Pharmablogger

The Children's Tylenol Statement

2010-07-31T08:06:00.000-07:00

This is the statement being appended to all adverse event reports related to the recall of children's products from McNeil's Ft Washington plant, including Children's Tylenol. No other comments here - PB will just take the Wikileak role. We report, you decide.

Additional information received on 11-Jun-2010

On April 30, 2010, McNeil initiated a voluntary recall of multiple liquid products manufactured at the Fort Washington facility that are within product shelf life. Some of these products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles.

1. A total of 26 lots were manufactured with Avicel RC591 FMC (supplier) lot DN08819943 as an inactive ingredient in some lots of the following products: Children's Tylenol Suspension 4 oz. Cherry, Infants Tylenol Suspension Drop ½ oz. Grape, Infants Tylenol Dye Free Suspension Drop 1 oz. Cherry, Children's Tylenol + Cold Multi-symptom Suspension 4 oz. Grape, Tylenol Pediatric Cherry Suspension Hospital/Government 4 oz., Children's Tylenol Suspension 4 oz. Grape, Children's Tylenol Suspension 4 oz. Bubblegum, Tylenol Grape Suspension Drop Hospital/Government ½ oz., 15 ml package, Children Tylenol Dye Free Suspension 4 oz. Cherry, Children's Tylenol Suspension ½ Cherry, Children's Tylenol + Cold/Cough Dye Free Suspension 4 oz. Grape and Infant's Tylenol Suspension Drop 1 oz. Grape. Subsequent to release of these products to market, it was discovered the supplier had separated out a portion of the lot for the presence of gram negative organisms. That portion of the vendor lot was not shipped to McNeil nor used in production of finished product. Corrective actions had been previously implemented with the supplier. No additional corrective actions are needed.
2. 3 of 10 lots of Infant's Dye Free Tylenol Drops, Cherry manufactured utilizing a 1000 gallon mix and 1000 gallon hold tank were rejected for failure to meet the potency specification for samples pulled from the end of the batch. The 3 lots were not released to the market. However, this batch size utilizing the 1000 gallon mix and hold tanks will not be manufactured in the Fort Washington facility without re-assessing the batch size development and re-validation of the process.
3. Other lots may contain tiny particles. Investigation to date has revealed potential root causes to be the filling equipment used in production and some raw material. Corrective actions are being developed and will be implemented prior to production resuming.

In all cases, the products were voluntarily recalled as a precautionary measure.

McNeil From the Ground Up - EXCLUSIVE

2010-07-15T19:24:00.000-07:00

Not yet released to the media (I don't think):
Johnson & Johnson announced internally that they are closing their Ft Washington, PA McNeil Consumer division plant until well into 2011, and laying off at least 75% of the operations staff there. This includes manufacturing, packaging, QA, planning and other staff. There are non-operations personnel there who are not affected. This site was where the recalled children's liquid products were produced.

The layoffs are considered permanent, but when they re-open the plant in 2011, they will consider re-hiring laid-off staff. The re-hiring will be on a much smaller scale however, as they introduce much more automation into their processes. They will also likely hire people as contractors, to avoid paying them benefits, according to Pharmablogger's unimpeachable sources.

The plant is being rebuilt from the ground up, literally. The new floor will be poured soon, for example. The effort is to make the plant "pharmaceutical grade" (what was it before?). Meanwhile, the FDA continues its proctology examination of the company, with a J&J Toronto plant in its sites.

Laid off workers will have an option for severance of 2 weeks for every year of service. It was a tough day in Ft Washington today, we hear. Coasting on your reputation for too long will only earn you hubris and disaster.

Do you recall.....?

2010-05-25T17:43:00.000-07:00

Pharmablogger loves stories of executive follies. Now, there's nothing new about the Johnson & Johnson / McNeil recalls of Tylenol products for various reasons, but pharmablogger has learned that J & J CEO William Weldon (2009 salary $25.6 million) can sit back and bask in the glow of triumph, as he seeks to make McNeil as low-cost a manufacturer as possible. You see, in one drive for economy, McNeil switched bottle manufacturers in Puerto Rico, to a company that used Brazilian pallets that were not heat-treated, but rather chemically treated, resulting in that musty smell that greeted users of Tylenol Arthritis and other products. The smell came from the interaction of the chemically treated pallets with the bottle resin. Yet, J & J came out ahead, right? After all, according to internal sources, the company saved $820,000 by switching bottle suppliers! WOW!

So if you're a J & J stockholder, you might want to let him know how much you appreciate the savings, unless you think the (currently) estimated $1.2 billion in lost sales (source: NOYB) before CAPA costs are figured in, overshadow that $820 large.

Heavy Metal Poisoning

By the way, don't be concerned too much about the metal particles in your kids' liquid Tylenol or Motrin. It's probably always been there, and heck, kids have been getting healthier every year, right?

You see, the liquid filling machines at McNeil have been washed between productions runs with 190 degree water since, well, a looooong time ago. What happens when metal heats up? That's right, it expands! And the liquid fillers have pistons which make the dowels go up and down, where they rub against other metal when expanded. But it took a packaging mechanic to notice the particles in bottles of water that were run after a maintenance service. Irony - that particular maintenance took place because the same bottle manufacturer had sent McNeil bottles that were too thin, so packaging was suspended for a while.

What about other findings from the FDA, that made the Fort Washington McNeil plant sound like a rat hole? Well, when you lay off 2/3 of your maintenance staff, you're going to get things that go unrepaired, like holes in the ceiling. Or when you lay off much of your packaging staff, and a line goes down, all you can do is re-allocate the remaining people to other lines, rather than waste precious time getting materials off the down line, where they will remain exposed to the air and get "grimy" over the course of a few hours (really?)

Then there are those skids of recalled product that were accidentally shipped back out to customers (whoopsie!) because McNeil and J & J systems don't adequately talk to each other.

I'd love to be at this week's hearings, and maybe I will be if schedules permit. Let's hope the House Oversight and Government Reform Committee, and Senator Tom Harkin ask the right questions.

PB to ailing William Weldon: Got your back, buddy! Get well soon!

Not a good week for AZ....

2010-04-27T14:15:00.000-07:00

AstraZeneca loses patent case against Dr Reddy's, and then has to cough up court costs.

My favorite passage:

I certainly hope that this ruling chills the sort of unreasonable, frivolous, anti-competitive, anti-consumer litigation in which plaintiffs here engaged. This lawsuit was nothing more than an effort to keep a legitimate competitor out of the market on flimsy-to-nonexistent grounds. Plaintiffs did not engage in zealous advocacy here; they engaged in litigation misconduct. They abused the litigation process and needlessly consumed the scarce time of the court.

Profile of a company founded on fraud?

2010-04-26T17:24:00.001-07:00

Try to get through this complaint against Cephalon, involving their mainstay product Provigil. One of the better class action complaints I've read.

What's the next step?

2010-04-26T16:44:00.000-07:00

Every year I had to complete training as part of the AstraZeneca Corporate Integrity Agreement (CIA) for improper marketing of Zoladex, which cost AZ about $250 million in fines years ago. Now they will enter into another CIA for Seroquel due to additional improper marketing (can you say "sleepoquel?" Google it). Everybody in the company knew that prisoners and nursing home residents were being fed this stuff in sub-therapeutic doses (for psychotic disorders) to keep them sedated. It was obvious from the sales data. So how does management, particularly sales management, get away with simply negotiating a second CIA? Why isn't there any jail time here? $520 million is slightly more than one month's sales of the drug. As a business decision, this was a no-brainer. If the market for off-brand sales is big enough, DO IT! Your stockholders will applaud you. They may even demand it of you.

Bureaucat vs bureaucrat

2009-12-17T06:31:00.000-08:00

The U.S. Preventative Services Task Force, which has been loosely described as a government body or agency, made now-infamous recommendations about mammograms, that have set my neighborhood all atwitter. "Obamacare looms over us already" is the general theme that outraged Americans of every (red) stripe is expressing.

Well, what a triumph this episode truly is for those of us supporting universal healthcare, snatching it from the voracious jaws of the insurance industry. Let's compare nonsensical statements of the recent past, competing for stupidest expression of outrage in 2009. We've all heard "Keep your government hands off my Medicare!" by the senior teabagging set (no snickering, please). How about laments about government bureaucrats controlling our healthcare coverage choices? That has to be about as dumb.

You got insurance? PB does too. You ever have to argue with your insurer about coverage? Yep, been there myself. But PB knows that government-based universal coverage comes with something no private plan has - 535 ombudsmen, eager to be outraged on your behalf. A task force makes a scientific recommendation about mammography that no one likes? It gets shot down faster than a hydrogen trial balloon at Lakehurst NJ. The American Cancer Society changes its position within five days, and legislators fall over themselves racing to microphones to express their indignation. Clarifications are issues, task force members go on NPR to re-explain what they REALLY meant, and patients remain fully covered.

What if a private insurer had examined its own actuarial data, came to the same conclusion about mammograms starting at 50 years old, and simply imposed that on their customers? What group would race out to condemn them, and force a reversal in policy? With universal government coverage, the time from unpopular coverage change recommendations to reversal would be measured in nanoseconds, as 535 congresspersons jam government printers with legislation to force HHS or whomever to pay for all the prostate exams, mammograms, chiropathy, and Native American Medicine Wheel interpretation they can consume.

Thinking like the big shots

2009-12-17T06:09:00.001-08:00

Employee parrots

While my previous job winded down, it became too boring to discuss here. PB apologizes for the funk.

But one of my last activities was a course for project management, that was mostly notable for the sad things PB heard during group participation activities. Groups were formed to solve various hypothetical problems using project management techniques, and the assumptions that each group displayed would have Eugene Debs rolling in his grave.

99 out of 100 people in this industry (my unofficial estimate) have completely swallowed the Kool-Aid concerning lay-offs. The industry line: "We will try to find a place for everyone who has been displaced by this action (outsource) but we can't make guarantees." Of COURSE they could. They just choose not to. But the PM class participants who had to lay off people as part of their exercise didn't consider any alternatives. And they're all on the chopping block themselves. Shameful brainwashing.

PB has executive sympathy? Yeah, kinda.

There was also a recent, unspoken yet clearly discernible frustration voiced by our execs, and I actually found myself in agreement with them. Following continued 30% and above year after year profits, our stock has gone nowhere. Our industry profits were barely touched by last years recession, and indeed gave big pharma huge opportunities to gobble up smaller firms with new technologies and drug candidates. So, what's with the plummeting stock prices? Our execs are required to meet with fund managers, Wall Street analysts, and so forth, to describe our business, and explain how they will continue to make their reliable profits. How about some of those investment gurus explaining THEIR business to US for a change. Hell, at least we manufacture stuff that people still buy. They just lose tens of billions (Mr Potter secretly pocketed it all at the bank!) and get bail-outs.

Looking for a Change

2009-08-29T14:48:00.000-07:00

Pharmablogger is about to be on the street. Yep, I need a job (you can tell how personal this is because I'm back to using the first person singular). It's been about a year since I've posted here, and I have no idea if anyone will pick up on this entry. Perhaps I've been ousted from your respective Google reader lists from lack of activity, maybe I just frustrated you. But if you like what I've written, and feel that my kind of knowledge about the pharma industry may be valuable to your firm, then contact me, and we'll discuss any possibility. I'm not posting a resume online, because despite any redaction of personal information, my anonymity would be still be blown.

In all seriousness, PB is concerned about impending unemployment, and I would greatly appreciate any leads, any offers, etc. Thank you my friends.

The Good, The Bad

2008-08-01T15:51:00.000-07:00

The Good

Some interesting news this week about Alzheimers research. First was the news published in Neurology about cutting the risk of dementia with statins. Some physicians believe that the primary benefit of statins derives from their anti-inflammatory properties, rather than, or in addition to, lowering plaque build-up, and this mechanism would go a long way toward explaining the dementia benefit (or so we're told. PB is not a healthcare professional).

Anyway, we're reminded of the benefits that are derived from both widespread use AND disuse of common medications, that are not always recognized until years after their introduction. The mass adoption of classes of medications in a short time period, such as statins have experienced, will inevitably have some kind of public health impact that is not understood or predicted by clinical studies. The negative example is the rate of breast cancer decline following the steep abandonment of Premarin. We may all have lucked out with the statin news, but there are going to be as many negative findings as positive ones, and if pharma is eager to put a new pill in the hands of as many patients as possible in as short a time as possible, they better be prepared to do the public health research necessary to tease out the data to expose the next Vioxx problem.

The other dementia news was the anti-Alzheimers compound that we heard about, helping to detangle the brain. We enjoyed WIRED magazine's take on this. Our first exposure to the story named the drug as Rember, which set off an alarm. Drugs in the pipeline usually don't get a proprietary name until closer to launch, during Phase III trials, so we thought this was some alternative therapy story. But no, there appears to be actual research going on. The compound is about a century old, though. "In the Pipeline" talks about it in depth. And those clever Quakers are going to make it easier for all of us to know when we've got the disease. PB still remembers asking a physician colleague years ago how the diagnosis is confirmed. By cutting open someone's head and examining it after death, was the response.

The bad?

How 'bout them medication error blues?

Lots and lots of them, up 3196% over some time period. More than every other form of accidental death, except for car accidents, COMBINED. Same death rate as homicides. The FDA has replaced riskmaps with REMS but PB's experience with reading these things is that they are generally siloed approaches to medication errors, or they deal only with the possible interaction with some other drug or class. That's all they are supposed to be, dealing with a single compound.

The FDA has published advice to hospitals and the public on how to minimize problems but we'd like to see that backed up by industry marketing muscle. Since the industry recently cut off possible sales and marketing reform legislation with the new PhRMA sales code, how about a similar effort to build a comprehensive technological approach to thwarting medication errors before Chuck Grassley convenes hearings on that issue as well? Don't just worry just about your own meds, worry about how how many people are dying as a whole.

Film fun

2008-07-24T15:06:00.000-07:00

The truth is...at the supermarket?
OK, are there any other X-Filers out there who get a little freaked out by this?

Father knows best
A few years ago, Pharmablogger's sister gave us a copy of "Daddy Day Care," and our daughter, bless her heart, made it disappear faster than a dead hooker from Ben Affleck's trailer (hat tip: Kevin Smith).

Last night PB was watching a preview for Juno, when we began to think about our favorite "Dad" movies; films with Dad characters who are actually intelligent, caring, compassionate. So we decided to start a list here, and ask all of our reader to contribute their suggestions. No particular order to these.

1. Juno

Juno's dad says a few biting things to her when she announces her pregnancy, but he's a great supporter and friend to her, who simply didn't see this coming. Favorite line: "Hey there, big puffy version of Junebug!"

2. Fairy Tale

This is a bit of a cheat, because the Dad moment is very brief, coming at the very end, and that's all PB is going to say about it. Because if you have a daughter, you need to see this movie. PB cries at the end every time.

3. Bend It Like Beckham

Dad is played by Anupam Kher, who shows his true colors of affection to his daughter about halfway into the film, sneaking in to watch her play metric football, then finally intervening in the end to allow her to play in the finals, accepting her traveling to America for college, and so on. He's trying to balance holding on to family the traditions of his culture with his daughter's need to grow.

4 & 5. Bride and Prejudice & Pride & Prejudice

The same story, two different interpretations, two great dads. Both of these contain variations of PB's favorite Dad line in literature: Your mother will never speak to you if you don't marry him, and I will never speak to you if you do. What a great show of respect for a daughter, to tell her that she deserves someone who is at least her equal, even if that decision may impoverish the rest of the family. Anupam Kher again in the first film, and Donald Sutherland in the second.

6. Contact

Jodie Foster's Dad is played by David Morse, who learns that his daughter is gifted in math and science, and does a great job inspiring her to excel beyond all of her peers, and think outside the orthodoxy of her field. His influence is so strong that it lasts well after his death when she is a young teenager.

7. Say Anything

Perhaps a controversial choice, since Ione Skye's Dad turns out to be a felon. But John Mahoney's relationship with his teenage daughter still remains something of a model for me. Sure, he puts her on a pedestal, but he's done a great job (another single Dad) encouraging her achievement, and giving her great values, despite his own personal failings. And there's that famous scene where she confesses that she "jumped on" John Cusack, and then expresses relief at her comfort at being able to tell her Dad something like that. Dad holds back his barely veiled concern, because he raised her to be honest, she was, and he knows he has to respect that, or undermine everything he ever told her in the past.

More when PB thinks of some, or you suggest something....

Baseball liner notes

2008-07-20T12:28:00.000-07:00

Pharmablogger has noticed a trend toward feminization in sports, and a corresponding complementary trend in the opposite direction. We loved watching our daughter play softball this Spring, we note how baseball teams have worked hard to make ballgames more "family friendly," and we look forward to watching Ryan Howard leading cheers from the bench someday:

"We don't play with Barbie dolls, we just play with bats and balls.
We don't wear no miniskirts, we just wear pants and t-shirts."

We approve, since we would like to see our daughter win an athletic scholarship some day, and be capable of stuffing a field hockey stick up the rectum of any over aggressive suitor should the need arise.

And while PB once purchased a T-shirt at a breast cancer fundraiser that reads "Save Second Base," we must confess that the first time we saw those pink Phillies caps, we thought it must be Carlotta Tendant bobblehead night.

Anyway, we pause here to note some interesting (and dare we speculate, revealing?) quotes in the Inky last Friday. Mike Arbuckle, the Phils general manager, was discussing their latest trade for pitcher Joe Blanton, when he made this point about Blanton's appearance: "We feel his make-up is going to allow him to fit very well in a pennant race. He was attractive for a lot of reasons." I guess this move by the Phillies is just cosmetic.

Immunity?

2008-07-20T11:52:00.000-07:00

Since the Supreme Court granted immunity to Medical Device manufacturers in February, there has been heightened discussion about the court taking the next logical step, granting immunity to FDA approved medications, which may occur in the next Court session.

Pharmablogger will devote additional coverage and discussion to this issue in the coming months. For an interesting contrast of media coverage, see July 18th edition of the Philadelphia Inquirer. In the same paper, there was a slightly paranoid sounding article about a meeting in Philly between Pharma execs, attended by a "high ranking official" from the FDA, who was the featured speaker on the topic of immunity. The points about faulty FDA review were spot-on, but PB wanted to specifically call out one sentence: "These corporations will cry that complete immunity pre-emption is necessary because the cost of litigation is suppressing their research and development. That is a lie. " Amen. One of the best-selling pharmaceuticals in the country is an anti-schizophrenia medicine, which has already had one large line extension with bipolar disorder, and the company is seeking approval for an even larger extension with a claim for general anxiety disorder, and major depression. The patient population for this drug could explode even more, with GPs prescribing it. Yet this drug is also a huge litigation magnet for this company already. No matter - full (development) steam ahead.

The second Inky article is about Merck's approval of a settlement sum for Vioxx litigants - $4.5 billion. Now, PB has no journalism experience, and the first article seemed timely based on the meeting that the author discussed. But is it possible that the Inky held the editorial for a short while, knowing that a Merck decision on the settlement funds was imminent? Just wondering.

Overtreated

2008-04-06T19:37:00.000-07:00

If I haven't linked to this author, I should have. Shannon Brownlee wrote a good book, and she reiterates some of her arguments in this Washington Post article.

She gets a lot of milage from debunking osteopenia in this article, but as I read her criticism, something struck me as being inconsistant. True, most women with osteopenia will not break a hip, and true, most people with actinic keratoses will not have skin cancer. But my perspective has always been from the side effect world. The statistics that we use to determine a "signal" is similar to the statistics used to predict whether someone will come down with a serious ailment if they have a "pre-disease." So why is one predictive model more valid than another? Well, if you're taking a medication, there's an assumption that its actually doing something positive for you, to make the benefit/risk ration worthwhile. She's right about one thing - there is definitely a growing movement to treat conditions before they even are manifest by using surrogate markers such as low cholesterol or bone density. But don't throw out that surrogate marker philosophy completely. Isn't blood pressure a surrogate marker? Does anybody feel bad just because they have it, or don't they have to wait for the kidney damage first?

From NPR's "Talk of the Nation" - Saline issues?

2008-03-27T17:02:00.001-07:00

Wax on, wax off

2008-03-20T18:35:00.001-07:00

OK, if Peter Rost can devote unseemly amounts of column inches to Elliot Spitzer, than I'm going to feel free to wax poetical on the heels of our current financial crisis. The following is an excerpt from a poem I wrote a long time ago, called Who Wants to Play? from the perspective of an investment banker:

Our wages come not from the things we create,
but the miniscule squeezings of this or that rate.
I'll earn more than my father by producing much less.
He worked as a craftsman; I'll learn about stress.

The Fed is our lackey; it works toward our ends.
The families we shred, we demand that they mend.
You won't see it coming, then you'll blame the wrong fools.
You can't change a thing when you play by our rules.
We'll crush you beneath our invisible hand
'Cause you cannot resist what you don't understand.

Cheerful, huh? I was in an uncharitable mood at the time. Unlike today! I also wrote an Ode to the Federal Reserve back then. No, really. If you say pretty please, I may even publish it here.

Compare & Contrast

2008-03-18T18:34:00.000-07:00

I've been doing some fascinating reading about the admissability of adverse event data in a pharmaceutical product liability case. "Post-sale" duty to warn concerns the marketing experience, and the related spontaneous adverse event reports, and accumulation and analysis of data.

The Third Restatement of Torts specifically addresses post-sale failure to warn duty, and states that the duty arises "when new information is brought to the attention of the seller." There's no affirmative duty to continue to test (forgetting for the moment any Phase IV commitments) but the manufacturer is supposed to keep abreast of scientific literature and related developments.

Now, the Federal Register specifically states that ADRs are not conclusive of causality (21 CFR 314.80(a)). In fact, a company "need not admit, and may deny" causality of an individual report (21 CFR 314.80(k)). The FDA has also stated that “[a]ccumulated [AE] cases may not be used to calculate incidences or estimates of drug risk" in a 1996 report. These tidbits have been used by defendants to exclude expert testimony on the incidence of ADRs, and actual ADR reports themselves, which is a shame for the plaintiffs, because they make such fun reading for a jury. There are exceptions, particularly in a Bendectin case which allowed expert testimony in 1985. ADR reports can be used to prove notice, however. A plaintiff could argue that the mere existence of reports indicates that a company had notice of possible issues, and a clever lawyer would refer to a large volume of reports, hoping a jury would assume that a big stack of 3500A reports meant that the drug had problems, even if they don't get to hear about the content.

Anyway, this is all leading to the Baycol litigation, where the defense for Bayer had evidence about "AER data" excluded from consideration. The decision cited the Federal Register, and those FDA reports warning against using ADR data inappropriately. A quote from an affidavit from Dr Janet Arrowsmith-Lowe, formerly with the FDA and CDC: "It is a well accepted pharmaco-epidemiologic principle that the biases affecting AERs preclude their use in calculating rates of events or in comparing rates of adverse events among pharmaceutical products." The court cited her affidavit several times, and accepted her arguments.

But what if a company chooses to use that type of data in their own defense (click link for "Spontaneous Adverse Event Reporting Information...)? If they make the case that post-marketing reports demonstrate the relative safety of their drug, will they later be able to make the claim to exclude such data in litigation?

Back to the Eighties weekend....

2008-03-17T19:04:00.001-07:00

So, have you seen the advertisements for Yaz, the pill that also has indications for PMDD and acne?

If Yaz fails, and the woman gets pregnant, do they sell a morning-after pill called Erasure?

(Hat tip George H.)

The latest screed
New York Times book review of Melody Petersen's "Our Daily Meds."

Day One

2008-03-11T16:12:00.000-07:00

at the Health Law Institute was OK. Tomorrow looks more promising.

I had lunch with a woman working for a law firm which has some Big Pharma clients. She posed an interesting question to me, and I responded in kind.

Her client was asking about employees who have licenses as practitioners, who need to log some clinical time to keep their licenses. Some of these nurse practitioners are also sales reps, whose pay is structured on how practitioners in their geographic areas prescribe. What should be done about these nurse practitioners, whose prescriptions could theoretically affect their pay? Would this arrangement violate some kind of anti-kickback statute?

Well, Stark is not a consideration, since they are not physicians. But there may be state regs that mimic Stark, but apply to a wider array of prescribers. An obvious recommendation to the client would be to restructure their pay for the period when they are in the clinic. Fascinating question though. I'd love to know what they eventually do.

I posed a question back to my lunch friend. If a clinical nurse educator is hired to address an interest group like an Alzheimers association, and they are required to discuss only the disease state and not their employer's medication, how might they still violate the Pharma code by inappropriate promotion? Well, the answer may lie in the clinical development strategy the company pursues, through line extensions and sNDA applications.

Did you ever compare labels and indications between two or more drugs in the same therapeutic family, which are fundamentally identical in mode of action. Go ahead - look it up with the statins, for example. PB will wait.

OK, you back? The clinical strategy for these compounds has been geared toward creating something unique in their indications that the other compounds haven't got. So, when nurse educator Betty speaks to a bunch of cardiologists about lipid-lowering strategies, and discusses the need for the patient to reach certain benchmarks in their therapy, wouldn't it be convenient if her company's compound happens to be the only one indicated to reach those benchmarks? She never needs to mention the drug name, as long as she pounds the message about the therapeutic end-points repeatedly. Then the sales reps for the attending docs can follow-up with a visit sometime later.

Free pharmaceuticals for everyone!

2008-03-10T16:46:00.000-07:00

Industry executives have banded together to announce a program to distribute health-affirming pharmaceuticals for free for every American. According to a press release from the world's most profitable industry, the program is already in place, and Americans have been benefitting by ingesting drugs that will help to lower their blood pressure and cholesterol, relieve pain, and encourage bodily growth(s). The program is being touted for its low price and convenience. The industry is rolling out the program with no charge to patients, and distributing the medications conveniently through drinking water. "We may consider a way to try to charge patients for this largesse in the future," stated one industry insider, who wished to remain anonymous. "It's outrageous that patients can derive a pharmaceutical benefit like this without any remuneration whatsoever. This makes the Canadian problem seem trivial in comparison."

Legal fun!

2008-03-04T17:46:00.000-08:00

Yeah, I do this stuff 'cause I love it.

Pennsylvania Bar Institute's "Health Law Institute," March 11 & 12, Philadelphia Convention Center.

If you're in the mid-Atlantic area, and there are lots of us Pharma people around here, check out this two-day affair next week if you have the chance. PB will be there, and I wish I had posted this earlier to give you a chance to book ahead. Still, its cheaper than most Pharma conferences. The Health Law Institute is not only Pharma topics, or even mostly. But there's plenty to learn about there, and its much more interesting than the last industry conference you went to, I guarantee.

Give me a holler if you will be attending, especially if you're going because I recommended it. Thanks!

Campaign fun!

2008-03-02T14:59:00.000-08:00

The Philadelphia Inquirer reports that the race for pharma campaign bucks has now tilted overall to the Democrats. Hillary Clinton leads all comers with $408,000 in contributions, but you won't hear Barack Obama complain too much about that, because he's only about $8000 behind her. John McCain remains as the one candidate who can spout off all he wants about Big Pharma, having collected only $112,000 or so up til now. And spout off he does. Read into the Inky article to get to some of his choicier quotes from the campaign trail. He's up to speed about the Medicaid lawsuits that just returned the first verdict against a pharma company in Alabama and he's no fan of Medicaid Part D, either. He clearly indicates that he wants to introduce more price competition into that program.

Billy Tauzin is quoted, acknowledging the "sea change" in contribution patterns toward the demos, but he doesn't sound phazed by McCain's comments.

Wanna have some fun? Navigate to this page at the Federal Election Commission and type in your company name in the search field. Let's find out if Frank down the hall has made a contribution to anyone! I don't know about you, but my company is always trying to get people to contribute to the company PAC, including inducements like making a contribution to a charity of your choice. It's guaranteed to be voluntary with no retribution, but they've never guaranteed anonymity, because they can't. Give to the company PAC, and your name will appear on this publicly accessible website, same as if you gave to a candidate directly.

John Roberts - Due Diligence foe?

2008-03-01T09:28:00.000-08:00

I have a feeling that Chief Justice John Roberts wouldn't care for aspects of my job any more than I do.

When I heard Nina Totenberg quote Justice Roberts on Wednesday evening: "I don't see what more a corporation can do," he said. "What more can the corporation do other than say 'Here is our policies' and try to implement them?" I recognized a kindred spirit.

Why are we hounding our vendors to send us everything they find regarding adverse events, when no other corporation is? Why are we telling our employees to call in every time they hear Aunt Millie complain about her gout worsening, just because she's been taking our blood pressure drug for 10 years?

Because we have no other ideas on how to get any meaningful safety data, and neither does the FDA. We're using these lame methods to pump up our database with nonsense, to show the FDA what good due diligence we pursue. The high-powered epidemiogist brains at our company and FDA can't imagine a requirement for practitioners to report suspected ADRs, or even serious ADRs, or even FATAL ADRs. No, we're going to depend instead on the screening skills of whoever picks up the phone at our rebate fulfillment centers to recognize when a patient is inadvertantly mentioning something negative, however trivial it may be.

And I think John Roberts doesn't care less if we do all this. We've got our policies, and we're generating lots of meaningless data from them. Big deal. I'd like it if John Roberts or somebody else with influence would require us to stop concerning ourselves with every potential petty interaction with patients, and require us instead to practice real science.

M. Butterfly, a review

2008-02-08T20:35:00.001-08:00

The current ************ Theatre Company production of M. Butterfly tells an extraordinary and Tony-award winning story, with amazing visual production values. The backdrops are beautiful segmented rings that take on different emotional hues with every sudden change of lighting. Sometimes, too sudden. A little more subtlety might have improved some of the transitions.

But that's the tone of the entire production from the acting perspective as well. The director's notes in the program state that he is no fan of realism and naturalism, scoffing that he can find that just by looking out his window. So his cast attempts no naturalistic acting, with the partial exception of the character Marc, libidinous friend to our protagonist Rene. Butterfly's falsetto makes no attempt to deceive, especially when paired with a rather prominent eyebrow ridge. And the famous five-minute segment where he changes from kimono to business suit and removes his make-up loses the astonishing impact from the original production. This is all by design, and it turns the play into an intellectual discourse on East and West, male and female, reality and fantasy. The audience is not drawn to the characters emotionally. This reviewer felt nothing as the tragedy unfolded, but perhaps I was able to think more about the points brought up during Rene's overlong soliloquy at the conclusion...

-Excuse me, what are you doing?

I'm writing a review. I went to see a play this evening.

-What does any of this have to do with pharma?

Well, nothing I suppose. I just felt like writing, raising a few points I was thinking about...

-But this isn't the place! Leave your intellectual masturbation at the door.

Screw you, its my blog. I can write whatever I want.

-Not if you want people to read it.

This is psychotic. Who the hell are you?

-How about if I guess what you are. A frustrated pharma employee, a wannabe something else, a jerk with a script half-finished on his flash drive...

Screenplay, thanks. So what?

-Oh, wants to be a movie writer? Lemme guess, the story of your pathetic life, made profound somehow. Maybe you can scab during the strike. Who do you have playing you?

Edward Norton, asshole. (Flips through the playbill) Anyway, look here at the benefactor list. GlaxoSmithKline, Shire, Johnson & Johnson...

-Tenuous my friend. Your point?

Well, maybe I don't have one. Or just that pharma money goes everywhere, supports everything.

-We know that already. But Arts are good.

Yeah, I agree. I mean, I actually paid for these tickets, but we've got VPs on boards of various theatre companies, regional symphonies and so on. I've gotten all kinds of free tickets over the years.

-Stadium boxes?

Yeah, but they're harder to come by. At least for me. The sales and marketing guys use them.

-So, whore you've been, whore you'll be again?

I'm not sure if I'm the whore or the pimp. Or which is worse.

-Sounds like you have no self-respect.

Probably not. Neither does a business willing to pony up $650 million in fines, and claim it was just due to a difference in interpretation of Medicaid rules. Totally innocent, of course.

-Yep.
-So how do we end this?

One fine day...no longer to live with dishonor.

-Let's not do anything hasty....

No. Its too late for haste. Good night, my butterfly.

A question for my new friends

2008-01-30T18:24:00.000-08:00

A vendor stopped by the other day, and we had an interesting chat about what they are doing for my company, and any legal issues that might pertain.

You see, they're performing social media monitoring for us, for a number of our products, and for our corporate image in general. They're checking out a number of blogs, using technorati and other blog rating tools (I forgot to ask about blogshares! Pick up your shares of pharmablogger today! Cheap!). They're following product discussions on cancer and psychiatry related patient websites. And they're giving us reports on everything they read.

I thought about one of our products in particular that has two key characteristics that interest me. First, it the subject of massive litigation, and second, it has a large amount of sales for off-label uses. Now, I've previously invoked the Divine Wow in these pages, asking that he guide our sales force to be not advising docs about these off-label uses. So for the moment, let's assume my prayers have been heeded, and we won't be on the wrong end of another Neurontin suit.

Yet our product teams are receiving reports about all of the off-label use of our drug from these vendors, as well as reading accounts such as this Wall Street Journal article about dementia patients, accompanied by warnings from the FDA like this. We also know that we're selling outsize amounts of low-dose tabs of our drug, that would not amount to therapeutic doses for its intended purpose, but are enough for the common off-label use. And then there's the IMS Health data. In short our sales force know what's going on out there.

So with all this knowledge about our product and how it's being used in the real world, how protected are we by simply claiming, however accurately, that we're not actually promoting the off-label use? Or in other words, does all of this awareness impose any duty on us to act, to warn, to advise doctors not to use our product inappropriately?

I posed the question to the vendor, and asked if they are providing any legal advice with their website content reports. That's not their function, it turns out. It should probably be mine, but I'm too tired to do the Lexis search tonight.

Even if I didn't find anything, just imagine the jury impact of the facts above. Our company is raking in billions of sales from a product that has a huge percentage of off-label use, that is inappropriate and harmful and maybe even fatal according to the FDA, and we're very aware that this is taking place, even if we're not instigating it, and we're not doing anything to stop it. How would you rule?

I might also add that we are not the only ones researching ourselves on the net. The plaintiff firms and "natural products" companies are doing it as well, but at least we're not actually posting or steering discussions in the patient forums (fora?). Heartening to know we're at least a half-step more ethical than law firms, isn't it? And of course, all-natural products never harmed anyone, right Socrates?

Equalizing stem cells

2007-11-21T13:58:00.000-08:00

From the reality-based community viewpoint

"The reprogrammed skin cells, by contrast, appear to hold the same properties as embryonic stem cells" according the New York Times.

Presumably, that also includes the ability to grow into a full-fledged human being, if implanted into the proper medium (uterus). Yet theologists such as Richard Doerflinger hailed this advance as the solution to the moral quagmire of embryonic stem cell extraction, which now may not require destruction of an embryo, anyway.

Why is the reformulated skin cell OK to use? If its identical to the stem cell that became my fetus 39 years ago, what makes it OK to experiment on now? Put another way, if I have embryonic stem cell "A" in my left hand, and a re-formulated skin cell "B" in my right, with either having the potential to grow into a human, what makes the one in my left hand holy?

Is it intent? The cell on my left was created by a process of fertilization that was designed to create a new person. Does some kind of "fit-for-purpose" spiritual calculation imbue that cell with a soul upon the biological union of sperm and egg? That immediately makes me think of the 75% of all embryos and fetuses that are naturally disposed of, never destined to develop because of a defect, or because the host mother is unable to house them. They were created with the same intent.

I'm sure Catholicism has an answer for that question, since it's not new, and that's actually something I admire about Catholic scholarship, from Augustine onward - the attempt to use rationality and logic to define spiritual boundaries. Its the convoluted results of that scholarship that leaves Catholics open to scorn from other Christian sects, but at least they try.

This is how it went that night.

2007-09-30T22:12:00.000-07:00

Since a recent posting concerning the deteriorating health of my mother, there have been further developments. She passed away last month. It is the scene of her final moments that I wish to describe.

I talked about the probably medication errors that brought her to the hospital. Now, we used a different medication to help end her life.

I was called to the hospital by my three siblings, who had been there a while. They wanted to increase her morphine drip, knowing that the increase would likely be the end of her already labored respiration. But they waited for me to arrive first. When I got there, she was on her side, and each breath made her face look like a fish gasping fon land. Her eyes were open, but not seeing. There was no one else in the room. Since my sister is a nurse in that hospital, she could control the rate of the iv drip.

I was rather alarmed. I wanted to better understand what was happening. I know that my sister wanted Mom to be out of pain, but were we killing her?

I spoke up, and asked that question. Everyone was distressed, but we could still have a conversation about what was going on. My sister asked me what I wanted to do, which was difficult to answer. She wasn't being flippant - there she was, in possession of much greater knowledge about the situation than I could hope to have, but she really wanted my opinion. I asked, what was she really dying from - would she be dying anyway, and were we just hastening a process with the morphine, while sparing her pain. She was bleeding internally, and there was no way to access the bleed without invasive surgery, which we had declined to do, since she would not survive the procedure with her co-morbidities.

Sister went ahead and increased the morphine, and within a few minutes, the very loud labored breathing quieted down. Her eyes remained open. I positioned myself seated by her head, my nurse sister to my left. She was talking to Mom constantly, giving reassuring statements which were likely not heard. My other sister and brother were on the other side. Over the course of several minutes, her respiration continued to drop, as well as her heartbeat. Sister mentioned that when her heart rate dripped below 60, her pacemaker would attempt to kick in. It did, creating a short spike on the monitor, but it didn't last. Her vitals continued to drop quickly from there, and then she just stopped all motion. Her eyes remained open, and the rest of the time we were in the room, and we said goodbye, I considered closing her eyes, but did not.

One bizarre moment was yet to occur. We had to get the attending ICU physician to declare her death, so we called the floor nurses to get the doc. It was about 2 am. I watched him stumble toward the room, he walked in, banging his shoulder on the partly open glass door, walked past the four of us, peered over her, turned around and said "well, she's at peace" to nobody in particular. He stumbled out, banging his other shoulder on the same door. No acknowledgement of any of us. Nothing like "Hi, I'm doctor whoever, I'm sorry for your loss.

JMK (nee H) 1928-2007

Social Media Marketing

2007-09-25T13:28:00.000-07:00

A new term for me, courtesy of a vendor who will be carrying out this function for my company within a few weeks. It means blog monitoring, in short, both the posts (like this one) that write about your company or product, as well as the feedback the blog postings generate (like all three of mine). I was aware of activity at my company that scrutinized sites like WebMD and the major disease sites like the various Cancer societies, but now we're talking about a bigger rabbit hole.

We'll be jumping into it headfirst, looking for postings for one of our asthma products. Google and Technorati keyword searches, board tracker software, etc.

An anonymous screen name is not enough to warrant action normally for an adverse event report. That's just not a valid, identifiable patient or reporter. But we've made exceptions in the past if the poster describes a serious adverse event that we have a particular interest in for that product.

I'm a little unsure about the value add for this kind of activity. Last Spring, our pro-active monitoring of Cafe Pharma revealed a very embarrassing post by a named individual in our sales force, that compared physician visits by sales reps to grabbing money from a cookie jar. It still made it to Peter Rost's blog, but we did fast damage control by being aware of it that much sooner. Pharma Blogosphere has information about posing as consumers on blogs, but we've never reached that point, and I doubt we will, considering the scowling glances that our legal folks brought to the table, simply at the mention of monitoring sites.

Recent experience is very interesting. For another, more controversial product, we uncovered artificial blogging activity that was an attempt to create business for law firms. One poster would write "I started taking this medicine, and this terrible thing happened!" and the response would be "That happened to me too! I just got a $100,000 settlement for it though. Check it out!" and the whole thing was an elaborate fake. There would be a banner at the bottom for Dewey, Screwum and Howe law offices. We managed to take action, but my readers will be aware that we were (and still are) awash in legal cases.

Speaking of which, I just participated in a review of a regulatory document for a legally challenged product that was hardly a joy to read, as it was all about patient deaths. As I alluded to in a previous post, there are concerns that the legal case overload will throw off our ability to detect genuine safety signals. If our spontaneous caseload normally equals x% of the background "noise" for a condition or event, but the case load for one particular issue skyrockets and clogs our database, our statistical analysis must be reconfigured to handle that, or else a separate analysis is undertaken to discount those legal cases. The latter is what we've actually done. So for this document, the discussion of legal cases was made separate from the rest.

A special shout-out to those of you who let me know you've added my blog to your Google Reader accounts. Let me know if you got this.

Reflections in a Glassy Eye

2007-07-27T19:14:00.000-07:00

How PB's Personal Life
has been affected by medications is not a new topic. I've mentioned personal issues with my wife's medications, for example. Now the subject is PB's mother, the likely victim of a medication error.

Mom was rehabbing a severe hip problem, when the staff at the residential rehab place gave her an injectable anti-coagulant (not heparin - the name escapes me. Long day.) apparently without discontinuing her Coumadin. They also gave it IM instead of in the gut, where it's indicated. A hemorrhage ensued, accompanied by the usual complications of low hemoglobin, hypoxia, etc. A hospital acquired pneumonia followed.

The hemorrhage was stopped, and Mom recently returned to a different rehab place, to resume treating the underlying mobility problem. I might add that she has unbelievable insurance coverage, thanks to Dad's employment at another Big Pharma company, which ended in 1983. She pays the first $500 out of pocket for anything - docs, meds, whatever, and nothing else after. Not a dime. Can anybody beat that? I can't.

Since being in the new place for a few days, Mom has been "out of it" - glassy eyed, can't find the right words while speaking, and memory loss. This was a very sharp 79 year old woman who was taking college classes last Fall. There are a few different possible reasons for this - her hemorrhage trauma and associated blood problems may have caused some damage to her brain, she has had poor blood oxygen off and on, and her pneumonia continues, but you wouldn't know it without an x-ray. PB also found out about another possible cause - she started Zoloft at about the same time. I need to research possible adverse effects of that SSRI.

Anyway, what drove me to post all this was the reaction I had today from a visit with her.

People visit their elderly parents for a variety of reasons. They are dutiful, the visits are good for the patients, etc. I have a 96 year old in-law who is visited regularly, which is wonderful, but it's not for the sparkling conversation. PB visits Mom because she is an intelligent and interesting conversationalist. Today was very different. It felt like the dutiful visit from the son with all the conversation in one direction, while she stared into the middle distance, smiled and nodded, with no other reply. This was disturbing enough, but when I spoke to staff members about this, they seemed all too eager to dismiss it with simple explanations. It's the meds, or the PT has her tired. Sounds fine, but it's BS. She's been on meds harder than anything you can buy on the street, and was never like this. She's had terrible arthritis for over 30 years which has worn out her body, and was never like this. She wasn't like this two weeks ago. But the staff doesn't know any of that, and frankly, everyone else whom they care for on this floor is in much the same zombie state. So why should they be concerned about the mental condition of a woman they don't know anything about?

As I sat with her during lunch today, I looked around at the 20 or so other residents, and it occurred to me how odd it is that so many people, with nothing else in common besides their age and infirmity, could act so completely identical to each other. What I'm saying is that every one of these people had some kind of personality at one time - there were former jocks, geeks, princesses, whatever, sitting in that room today, and if you subtracted 60 or so years from all of them, that would have been evident. But today they are all identical, with the same stare, no conversation, nothing at all to differentiate them except the color of their clothes.

I've been in a place populated by people in a worse state, who are experiencing dementia, and I noticed that an old personality re-emerges sometimes in that stage. Bullying, crying, and other highly emotional states come flying back to these folks when their minds lose a grip on reality.

But today, my mother was one of the starers, and it scared me to death. This is not who she is. I'm not ready to lose her mind, or to visit her out of a sense of duty. This sounds terribly crass of me, I know. If her brain was indeed damaged, than there may be no recourse. But when she did speak to me, there was fear in her glassy eyes too, because she know exactly what she's lost. She knows she wasn't like this a couple of weeks ago, and she doesn't know if she'll ever get her mind back.

A shout-out to my brother and sisters who live much closer to Mom than I, and have been such excellent advocates for her, especially A____. She's a nurse who is making sure the staff and the doctors know that something is terribly wrong with our mother's mental state, that this is NOT normal, and needs to be investigated, not explained away. I apologize heartily for every time I ever called you a bitch, dear sister.

Phrase of the Day

2007-03-25T17:35:00.000-07:00

PB learned a new phrase today, while catching up on George Will columns - "rent-seeking." OK, I've actually heard it before, without necessarily knowing what it meant, and I'm sure you business school types are scoffing at PB's ignorance.

It is not true that businesses, as a matter of principle, want to fend off government regulation. Businesses have a metabolic urge to make money, which is as it should be. But when a compliant government gives them the opportunity to use government regulations to enhance their moneymaking, that metabolic urge will overpower any principles about the virtues of free (from government intervention) enterprise.

Sound like anyone we know?

BTW, note the link on the right from the page above for the Pat Sajak columns. Did you know Pat was a columnist? PB is having an enlightening weekend.

March 15 WSJ

2007-03-17T04:53:00.000-07:00

By the way, if you can find a copy, pick up last Thursday's Wall Street Journal to read the front page article on cancer drug pricing. You can read a blurb here, in addition to some reader comments. I was considering commenting, but just about everything was said. I might add to the poster ("JIM") who is concerned about the economics knowledge of WSJ readers - Investigate how long it takes Pharmas to recoup that $1 billion investment. Not too long, folks. And how much of that $1 billion is real, how much is NIH, etc.

Face to face

2007-03-16T18:45:00.000-07:00

So, we'll be traveling next week up the turnpike to see counterparts from another Big Pharma, negotiating safety data exchange agreements. Or rather, observing the negotiation. This is PB's first face-to-face with another company. Yes it's true - PB is an underachiever, so to speak. I came into this racket late, after wasting a few years with more menial jobs. Now I'm not a youngster anymore, and I'm feeling it.

Anyway, the big legal issue with licensing for us has to do with reporting timelines, and the EU. Volume 9A, the European Commission's guidance document on pharmacovigilance (PV) was published in late January, and the big hit in licensing has to do with individual case handling reports (ICHRs). Specifically, the guidance explicitly states in Part 1, section 4.2, that the reporting clock date is set at "0" whenever the Marketing Authorisation Holder company or any company with a contractual arrangement with the MAH gets information about a adverse event. Ouch. Up until now, our practice has been to consider Day "0" the day when our company gets the report from our licensing partner. The deadline is day 15 - these are calendar days, not working days. So now we have to factor in much shorter data exchange timelines with other companies, and re-negotiate existing agreements.

Unfortunately, we don't have any electronic data exchange with our licensing partners. Our ability to do this is hampered by a lack of shared/compatible data standards and systems, and strained IT budgets. We're faxing and e-mailing case reports back and forth. We're doing this after the case has been entered into our own system, with our own internal timelines. Those internal guideline are geared toward our own company getting the reports in by day 15, not worrying about another company needing to do the same thing. Really, it's substantially shorter than 15 days already, because we've got to make the reports available to our marketing companies around the world, so they can submit the reports (usually a CIOMS) to their regulators.

So now, we have to decide either 1. Rework our individual case handling procedures to shorten our internal timelines, and expect our licensing partners to do the same, or 2. Assign one or the other of the companies to handle all of the reporting duties of a co-marketed drug to all of the regulators around the world, or 3. Share all source materials about adverse events with our partners the day they are received, and trust each party to send reports to their respective parts of the world's regulators

In reverse order, Number 3 is a non-starter, because our two companies could have completely different opinions on a case, if it's regulatory serious, listed with our core data sheet, etc. Then we would have two versions of the same case submitted to agencies, which would be a legal nightmare. We'd also never be able to produce a PSUR with competing cases.

Number 2 above can work fine if we're dealing with another large Pharma with established international reporting. They can do the case handling, submit the IPARs and QLLs to the Europeans for us, etc. The company I'm visiting next week can most likely do all that. But it gets really ugly when you've done a licensing deal with a company that only covers one country, like the US. If your licensing partner in the US is only selling your drug here, they have no reason to submit anything to European regulators. They may not even have the means to do so. And they probably won't tighten their internal timelines to get ICHRs to us quickly, so that we can.

So, we're often stuck with option 1, which is chaos and scrambling, or making exceptions for this or that product received from this or that source. Forget harmonization of processes. Or, my personal favorite variation on option 1, streamline your processes to cut out review times of ICHRs. Just type the case in and send it. This would put our reviewing physicians in a snit, but too bad. My company has too many reviews on an ICHR anyway. We've done some recent benchmarking, finding that other companies are just sending the reports, and worrying about medical review later.

But we know that *others* (Dr Wolfe, big law firms, David Graham at FDA) are scrutinizing our ICHRs, and our goal is to get the MedWatch exactly accurate before they go out the door the first time, being very careful with our wording. Franky, if you read my last couple of posts, it doesn't seem to be making any difference. We're under siege as it is, regardless of what we submit.

Not much. What's new with you?

2007-03-11T14:35:00.001-07:00

Legions of readers have been asking, so PB, what's been going on with you?

Well, we're happy to say we've conned ever more people into thinking we're doing a good job at work, and we're looking at a promotion within the next few months. There's cutbacks in other parts of the company, so that means that additional justifications have to be made for promotions, new hiring, etc. Really, that means that delays are built into the process, so we don't look so callous to managers who have to let people go. The company can say with some plausible deniability that they are not blatantly ignoring the company's bottom line by promoting PB when others elsewhere are being shown the door.

So, why are some people out the door? Over capacity created by incorrect forecasts, which were made incorrect by some high-profile late stage trial failures. Big ones. A shame - those were the products that actually made us proud to be in this business. They were innovative science, new approaches to unmet needs, etc. They just didn't work, was all. Details, details....

Legal Assault

2007-03-11T14:23:00.000-07:00

Ouch - over 1000 adverse event report in the past week and counting, all submitted by law firms for one product of ours. Our drug safety group has been scrambling to get these cases in the database on time, asking overseas offices to assist in the data entry, working weekends, etc. Deadlines will be met, according to the Veep of the department.

The reports for this particular product have been rolling in for about a year. We've got about 8000 total legal reports with named patients. If you've read Grisham's The King of Torts, then you have some idea about how this works. Now I'm seeing it from the other side.

If you Google the brand name of this product, about 3 or 4 of the top 2o hits are for law firms, but almost all of the Sponsored links are for lawyers. It's also under investigation by Pennsylvania for off-label marketing. This is a huge franchise, and we're counting on line extensions to keep sales up for at least 10 more years. It's a shame that a product becomes more well known for the negative news it generrates than any actual good it has done for patients.

We have little advance warning about when to expect discs arriving from a law firm with hundreds or more cases, but we haven't had to cry uncle yet. Still, the resource drain is huge.

Ouch - 7000 cases and counting...

2006-11-15T17:33:00.000-08:00

I almost forgot I had a blog.

Really. Some intereesting things have happened at work, but I forget to record them here. Busy busy busy. My blogshares are suffering terribly.

"King of Torts" comes to life

Yes, we've certainly received legal complaints based on Adverse Events before. But nothing like we're getting this year, for one particular drug.

A law firm in Massachusetts has sent us 7000 complaints, with individual patient identifiers, for one of our psycho-active drugs. Since each patient is named, that means we have to create a case in our safety database for each one. They are overwhelmingly described as having an unspecified illness, so these cases don't get reported anywhere, unless the patient has died. There's a handful of those. We have no idea how many more are coming.

We have a way of marking these cases in our database, so that they don't skew our statistics, which compare a particular instance of an individual event for a drug versus the background rate in the rest of our database. Basically, our database is a universe of patients, that can be used to find safety signals. Adding 7000+ meaningless cases to the database wouldn't help our statistical analyses.

I have absolutely no idea how we are planning to defend these, since no damages are specified, as far as side effect particulars are concerned. Just unspecified illnesses, wreaking havoc on patients' lives. If they named a particular ailment, it's probably on the label anyway. Then you'd be back to the restatement of torts again - unavoidably unsafe products, with warnings provided. They're going to have to provide specifics at some point. The co-morbidities of this patient population are extensive. I don't think this is going anywhere. Just giving our people busy-work.

This drug in particular was a target previously, because we had something listed on our Japanese label that was not listed anywhere else. Oh, the consternation! How dare we not warn the American people about problems that we are warning the Japanese about! Don't we care about Americans?

This went nowhere, because the Japanese label was mandated by the MHW, against our wishes. We didn't believe the Japanese label claim was justified, and we had the data on our side.

Critical look at Breastfeeding?

2006-06-15T06:10:00.000-07:00

My wife sent me a link to this New York Times article on the benefits of breastfeeding, and rather than just replying with a single word like "Interesting!" I sent her the following paragraphs that reflected my views on unfounded claims:

I am glad that there are actual trials underway totest some of the hypotheses that are claimed as benefits of breast feeding.
I'm always reminded of the assumed benefits of hormone replacement therapy, which were assumed to be true fortwo generations, and how shocked everyone was about two years ago, when they were all completely debunkedby a long-term double blind trial.
I'm not trying to downplay breast feeding at all, but so many claims are now being made (like less fussyeaters?!) without solid proof that the public support for breast feeding may come tumbling down if some of them are disproven, if no evidence of benefits hasbeen proven beyond a doubt. Do you get my point?
People love to read an article about something like fat (that a link between fat and certain cancers believed to exist were debunked by study last year) and then say - "See! I knew it all along! Those 'experts' don't really know anything, do they?" It's a profound anti-intellectual streak that runs through Americans. Get the proof, and don't rely on what you think must certainly be true.

My wife said that my reply was "worthy of pharmablogger" so I decided to post it here.

The Blogging Irony is Rich!

2006-02-22T18:50:00.000-08:00

...And they picked me because of my good looks and charm?!?!

So, here's one of my company's latest initiatives - spinning the blogosphere.

Yes indeedy, my company has hired vendors to monitor disease-related blogs and noticeboards, in order to see what kind of bile is being spewed by consumers, I mean patients!, about our products. And soon, we are hoping to influence some of that discussion. The plan is to hire medical professionals to log on to sites where there is negativity about our products, and try to steer the conversation in a more positive direction. Currently, we are planning to have these hired guns identify themselves as healthcare professionals, but not mention that they are (indirectly) on the company payroll, or connected to us in any way.

This is one of those things that you always suspect is going on in the blogosphere, but it is startling to actually hear that we are going to put it into practice. The net-savvy may catch on to this effort quickly, and identify our guys as company people. I hope so, anyway.

So what's my involvement? I've been asked to help out on a team that will evaluate the regulatory impact of the vendor involvement, specifically from a drug safety perspective. If these vendors are company agents, and one of the medical professionals that we've contracted with reads about an adverse event while participating in a discussion, what should they do? We are choosing to not identify these folks as company agents, at least initially. If they read on a board that product X killed someone's mother, what's the reporting obligation? Does that information constitute a legitimate report, with all of the required elements - identifiable patient, drug, event, and reporter?

The identifiable reporter is the sticking point. An anonymous blogger is arguably not such a reporter, but if I'm chatting with someone, would I have an obligation to ask that blogger to contact me or the company, explaining who I am? That would break the "cover" of our blogger, but good safety reporting should trump, right? If we get an email directed to the company about an adverse event, we record that event in our database, but the report remains "suppressed" unless the reporter also gives us more than just their email address. If we don't get a name or address, we email them back and ask for it. If they reply with that information, the case then becomes part of the database. I believe this is standard industry practice. We need a real name at least.

I'm not sure what our team may recommend. I've certainly browsed websites in the past that discussed my company's products, and even saw people mention what are clearly adverse events, but I never reported them to our safety department. But then, I've never done anything other than read the sites, not participate. Is there a meaningful difference, though? What do you think?

Feeling holier than thou?

2005-12-03T10:54:00.000-08:00

Well, hell yes. That's what this blog is all about, no?

Yeah, I suppose it seems that way at times. But now I'm actually feeling pretty good about the Firm, and I'll explain why.

I recently attended a forum where members of my department gave feedback to management about all sorts of issues, about which our management was found lacking, in one of those bi-annual workplace satisfaction surveys that my company conducts for all employees.

During this forum, I had a sidebar discussion with a physician, about the safety review process at our company. This is where all of our safety data is reviewed annually for each drug, and changes are made to the drug's labeling. He said that our company was the first he's worked at where there was no commercial input in this process. It is left entirely to the safety physicians to determine the contents of the safety sections of the labels. He had worked at four other companies, and singled out Wyeth as one where the sales organization had the largest impact on the safety review process. We have several other Wyeth alumni from the mid 90s, and I asked them how much the sales organization affected the safety group back then. They all just smiled, shook their heads gently, and walked away. I wonder why?

Economic models, and how we work

2005-11-01T18:10:00.000-08:00

No links, just thoughts

Today, my department received a presentation on a new model for international cooperation and harmonization of processes, raising issues, etc. We have three major sites worldwide in my group, and several satellite sites as well.

Just before this presentation, we were given an overview of the Companies efforts to promote Medicare Part D, by an individual from our government affairs office. All employees are expected to have at least minimal knowledge of the program, in anticipation of questions from family and friends that may come our way. To his credit, he was very upfront about the benefit to patients and the company by having hundreds of different plans compete for patients. Better to have hundreds of formularies to try to influence, than an all or nothing government formulary, was his message.

The contrast between these two presentations was thought-provoking. The Medicare presenter was part of the "commercial" organization, very articulate and polished, with a very persuasive message about the benefit of Part D to our company's bottom line. It's brilliant how patients' needs and the Company's benefits are perfectly aligned in so many issues. It's a great PR strategy, to always appear to be on the side of the patient, whether it be promoting "choice" Medicare coverage, or patient safety from counterfeit drugs (remember all those dying Canadians!) or on many other issues. More on that another day.

But the message about our department operating model was starkly different, in a political/philosophical way. Frankly, it was pure socialism in its design. It was all about centralized planning and control of processes, so groups or sites don't get too independent. It was stressed that we need to know how all the areas are operating, in light of FDA inspections that can occur anywhere in the world.

In a decentralized, capitalistic model of our department, we would all be given our goals for the year for output, and told to reach (or preferably, exceed) them in any way we saw fit, provided we didn't breach any laws. And I could not imagine anyone I work with would support such a model. This is a company and industry with an overwhelming (but not exclusive) alliance with Republicanism. But free market thinking just doesn't exist within my workplace.

Stranger than Fiction?

2005-10-28T19:54:00.000-07:00

"That's a nasty hack - you better take some medicine for it!"
The Puffington Host already had this, and Sploid picked it up from there, but I don't know if all of my reader(s) would see it there. In short, a guy was hired by PhRMA to write a thriller about adulterated drugs from Canada, poisoned by nasty swarthy types. The plug was pulled, and PhRMA's management claims ignorance about this project, set up by a "lower-level employee who acted without authority." The juicy part at the end of this? The book is coming out anyway, supposedly with a drug company behind the poisoning conspiracy! Bitchin! Pre-order today!

The plot thickens....
A reader asked me about possible plot holes in "The Constant Gardener," and I'll try to reply. How can a company hope to market a drug that quickly maims or kills a number of patients? The answer depends on what the drug is for - how deadly is the disease you're trying to cure? Specifically, in the movie the drug is being used for tuberculosis, and there are hints that the drug just needs "fine-tuning" before it can be submitted to regulatory authorities for approval. This is only conceivable if the "fine-tuning" has to do with finding the optimum dose range for the drug. You can't just muck about with the molecule, adding or removing an atom here or there to make it safer. Not yet, anyway. The closest I've seen to that sort of chemistry is to take an isomer of a drug, and to market it as a different compound, after testing. See this article for a good description, and some examples. An example of a film with an outlandish plot revolving around a bad drug, see "The Fugitive" where a drug ("Provasic" - great name!) to clear out blocked arteries was destroying patient livers. This drug would have been pulled within a few months after launch - it made no sense to hide such deadly effects during the trials, since the costs of pulling the drug off the market, with all the associated lawsuits and bad publicity, would be far more than just cutting your losses during clinical trials, and canceling the program. The truly paranoid just don't get that - we can't hide all the dead bodies, you know.

What...Me Worry??

2005-10-26T15:20:00.000-07:00

I had to take an annual compliance training courseonline today. It was the first time that I had evernoticed that it referenced bad acts by drug companies. For example, during the discussion of theAnti-kickback statute, it mentioned that "there hadbeen a number of high-profile case of pharmaceuticalcompanies..." who had violated various parts of theact. It also referred to "the corrupting influence ofmoney and gifts to the prescriber." I wonder how manyreps were able to to hear that with a straight face? After all, money and gifts to prescribers were theirbread and butter up until quite recently, andarguably, it still is. How else to bag the attentionof physicians on the go, if not for lunches anddinners? "I think you know my position on free food."- Kevin Costner, "The Upside of Anger"

Be Afraid...Be Very Afraid...of what?

A fabulous article that everyone should read appears in the NY Times today. Relative risk, folks. Thisarticle is for all of you idiots who stop using thesubway because you're afraid of terrorists, andinstead drive to work. Everyone I know needs a crashcourse on the statistics of harm (and lotteries too,but that's a topic for another day). Halloween isalso a good time to visit Snopes.com, not to mentionthe Department of Justice crime statistics. Acolleague of mine said today, "You just can't let kidsgo out trick-or-treating these days, like you couldwhen we were kids." Baloney. If it was safe ageneration ago, it's safe now. Our neighborhoods areno more infested with undesirables than they ever were- it's just that we can find out who they are, thanksto Megan's laws.

God bless the First Amendment

2005-10-03T15:55:00.000-07:00

God, I am so screwed....(see above)

But I love my granny....

Merck has tried an interesting line of defense, though suitable only for public consumption. The Philadelphia Inquirer reported yesterday that several key executives have revealed that immediate family members of theirs took Vioxx, in an attempt to dissuade the casual non-thinker that the executives are, in the words of Opus, "Incompetent fibbing poopyheads."

This sort of thing is not admissable as a defense, because it assumes a) that Raymond Gilmartin did not intend to kill his wife, and b) that they didn't decide to take their chances just to avoid the $10 co-pay. In other words, there are lots of reasons someone might choose one drug over another.

Meanwhile, clean arteries.

The AP reports that the cardiologist who treated the plaintiff in the Atlantic City Vioxx trial had clean arteries, in the "top 5%." The stories do not mention who the physician was testifying for - the plaintiff, or the defense. This news indicates that the pool of possible plaintiffs might be smaller than just anyone who had a heart attack while on Vioxx, if they've also got some artery clogging. The goal of the plaintiffs is make Vioxx the proximate cause of the injury, and the evidence shows that it increases the risk of heart attacks, not plaque.

Guidant is off-course

2005-09-29T17:42:00.000-07:00

J & J, Take Me Away!

Guidant has been maufacturing cardiac resynchronization therapy (CRT) units, that stimulate different parts of the heart independently. Recently, they have recalled tens of thousands of units due to short-circuiting problems. See this article for some background. Of course, Guidant isn't new to safety fraud...

Seeding trials?

I don't know much about clinical trials for devices, and how much they differ from drug trials, but in one respect, there seems to be a striking similarity. This New York Times article describes a that Guidant allegedly practiced, using an "evaluation" trial as a method to spur sales. This is right out of the pharmaceutical playbook of old. The company paid physicians to fill out a survey about the devices, $1000 for five forms. Chump change for Guidant, it turns out, since the survey resulted in

"...>$2 million in new sales with physicians who are not necessarily Guidant
friendly. We paid each physician who completed all five surveys $1,000 so
our
total cost was $80,000."

This is what used to be called a seeding trial - using a scientific pretext to generate sales, market share, buzz, or whatever.

Several documents were sent to the Times by someone professing to be an employee of Guidant, but there is no mention of whether there was a protocol for this "evaluation" or whether there was any consultation with IRBs or ethics boards where the participating physicians practiced.

Kick back and read on....

But you can't pay physicians to use your product - that's plainly illegal. So these evaluations have to be considered research to avoid the federal anti-kickback laws. To avoid violating the law, the research purpose for which you pay the physician has to be legitimate. See this presentation to get a better idea of the requirements. To quote:

"Clinical trials or other research with little scientific value implicate the
federal Anti-kickback Statute and IRS requirements. In addition, clinical
trial proposals that offer inducements to physicians to participate implicate
the federal Anti-kickback Statute."

The document then references the AMA definition of "Genuine Research Purpose" which you can find here.

"How can a physician tell whether there is a "genuine research purpose?"
A number of factors can be considered. Signs that a genuine research purpose
exists include the facts that there are (1) a valid study protocol, (2)
recruitment of physicians with appropriate qualifications or expertise, and (3)
recruitment of an appropriate number of physicians in light of the number of
study participants needed for statistical evaluation."

The drug industry has developed, through their trade group PHRMA, a Code for Interactions with Healthcare Professionals. More recently, we have promulgated new standards for clinical trial conduct and communicating their results. The first document was a voluntary code for industry, but has now been incorporated into law, in the sense that the most recent federal regulations on anti-kickback for the drug industry specifically cites the Code for Interactions, considering them to be a minimum standard. We may see similar treatment for the clinical trial standards.

At first blush, this may seem offensive. Since the industry wrote The Code, it sounds like the industry is therefore determining the law of the land for regulating themselves. I mean, who is supposed to write the laws? Should we have all industries write their own "Codes" and simply have the regulators defer to them?

However, we are persuaded that the PHRMA Code is actually not a bad starting point. In fact, we even heard Jim Sheehan, Associate US Attorney for the Eastern District of PA (Philadelphia) and frequent industry foe, refer to The Code as a good start, that fails only in that it does not address certain areas of conduct. In addition, by having The Code cited in the Federal Register, it makes adoption of this voluntary conduct a necessity to industry. No decent compliance or legal department would allow their sales folks to ignore it.

The Ectasy of Device Manufacturers

After a few more Guidant episodes, perhaps we'll see some similar reactions from the Medical Device Manufacturers Association (MDMA). A comparison between their website and PHRMA's website is instructive. PHRMA practices defensive medicine, knowing that it's an industry under siege. There are all kinds of articles and links to items showing how responsible and honorable they think they are. If we keep the pressure on, perhaps someday they'll live up to their own rhetoric.

Getting the Label

2005-09-27T18:21:00.000-07:00

How depressing.....
is this?. I might just have to take some Prozac.

Getting the Label

OK, let's talk a little about Vioxx. This is a pharmaceutical legal blog, and Vioxx is the big drug litigation story, so you'd think I'd spend more time on this.

Today, there's a telling AP story about Merck officials "getting the label" they wanted for Vioxx. The "label" is the package insert, which contains all the warnings and side effects about a drug, in addition to indications, pharmakinetics, chemistry information, etc. Getting the label you want for a drug is what clinical trials is all about - negotiating with the FDA, based on whatever trial data you have, to avoid warnings and precaution statements as much as possible. Negotiations sounds like a strange word in this setting, but it's what really happens. The drug company argues that there are too many confounding factors that prevent any assignment of causality. For a drug that is generally taken by sick people, this is an easier process for the company, since there is probably a substantial background rate of all kinds of ailments. For a pain drug, you have to consider the patient population who took the drug during the trials. Did they take it for arthritis pain, and are thus probably elderly? They probably take all kinds of other drugs then, with a whole bunch of side effects of their own. The VIGOR study was for rheumatoid arthritis, and if the patients were anything like my mom, they take a pharmacy every day.

In the big continuum that is drug development, before you even have a compound, you have a Target Profile. The profile tells you that you want a drug that does X, does not have side effect Y or Z (that the existing drugs in the therapeutic area have) and has a sales potential of $$$. Thus, you already have the beginnings of the label you want before you even have a compound.

I heard a lecture once from a drug safety physician in my company concerning a particular psychotropic medicine that had a warning about cataracts on the label, based only on animal studies. He had been told that getting rid of that warning was a high priority for drug safety, since it was responsible alone for losing hundreds of millions in sales annually. This was the first time that I heard a dollar figure attached to a safety issue, and it was clear that our marketing folks wanted us to go to the FDA with every argument possible to get rid of that warning.

So, the Merck folks came to the same conclusion about their drug, but they were more successful in their negotiations. They managed to convince the FDA to keep the heart attack information from VIGOR in the "Precautions" section of the label, instead of the "Warnings." This is significant not because the prescribers would notice the warning by themselves (they wouldn't), but rather the helpful competition would be sure to point it out to them, and feature it prominently in their sales materials. Imagine the script for a Pfizer rep - "Celebrex: the ONLY Cox-2 inhibitor without a heart attack warning."

The damning part of all of this is the attitude of the Merck players, as well as their stupid use of email. EMAILS LIVE FOREVER. Write them like they do. And remember - Merck was the most respected drug company in the country. If you asked a focus group about Merck two years ago, you'd get reactions like science, integrity, and so on. The evidence introduced in these trials should forever pierce that veil. How much of Scolnick's emails about VIGOR and the FDA had anything to do with patient well-being, do you suppose?

Tomorrow - Guidant was off-course!

See what happens while I'm away??

2005-09-22T19:35:00.000-07:00

Obnoxious...must stop...need guidance
Alright, fellow bloggers, how do I get this to stop? I posted about five minutes ago, and my inbox is getting filled with anonymous, clearly automated messages that read something like this:

Nice blog. Keep it up. I found this directory on How to drink and stay safe driving . I think it is a good thing that someone is educating us all on How to drink and stay safe driving. Simply PRICELESS!Imagine giving someone you love the opportunity to LIVE by giving them the proper stuff on How to drink and stay safe driving TODAY.

This is new since August - how can I make it stop?

Catching up with the news

2005-09-22T18:40:00.000-07:00

Much has happened since my last post. Headlines include the Vioxx verdict, medical device fraud with Guidant, many interesting articles about pricing lawsuits.

But I wanted to focus this evening on issues that are away from the news. One has to do with my criticisms of Medicare Part D and pricing.

A reader criticized my writing about government drug pricing (even accusing me of being a lawyer - what a cheap shot!). He referred me to a book on economics, and briefly explained how government interference in pricing distorts markets.

He was completely correct about the interference of government, but was too limited in his critique of government as a purchasing agent. He reminded me (and I can't believe that I haven't already mentioned this to you) that the Feds require that pharmas sell to them at their lowest price. This is true, and does indeed distort markets. I remember when my company was concerned about their Indigent Patient Program - if we gave away drugs for a few bucks in co-pay to the poor, would that constitute a price? And the TogetherRX program required a waiver from the pricing policy as well, according to my reader.

I am for market pricing - I haven't complained to anyone about the recent gas prices, for example, and found merit in the Wall Street Journal article "In praise of price gouging" or whatever is was called. But there is much more distorting the price of pharmaceuticals than the VA supply schedule. The three largest contributors to price distortion are the patent system for drugs, the regulatory burden of pharmas, and the enormous scientific subsidies they receive.

I'm not going to argue for the abolition of patents or regulations. Hello 1902. No, instead I want to give some perspective to help explain why exempting Medicare Part D from any pricing regulations rubs me the wrong way. The factors that drive up pharma pricing are almost overwhelming, and call for a restraining hand. For example, there is no such thing as a start-up garage-based drug company. Pharma CEOs do not look over their shoulders at lean and hungry start-ups the way Bill Gates has to. Also, you can't look at a drug patent, figure out a quick way to come up with an approved product, and have it on the market in weeks or months. Finally, there are huge gaps between the consumer, the learned intermediary (the doctor) and whoever is paying for the drugs. For most consumer transactions, these three elements are the same.

Think about the impact these elements have on pricing. And think what a small counterweight it is to have regulated pricing for programs paid for with tax dollars.

I've Done This Before...
but I can't help myself. There was a large ad for this item in the coupon section of my Sunday paper a couple of weeks ago, and I almost snarfed my cornflakes. I think I've mentioned before that I know many people who work for McNeil Consumer Products, and it's fun to call them and tease about this. Five years ago, this would never have happened, or so my friends like to believe. Get a real drug company, guys.

Switcheroooooo
You had to know I would mention this item, about the atypical anti-psychotics versus perphenazine. It's important to keep in mind that the headline writers are missing a big point revealed by the studies. While perphenazine performed well, it had a large number of patients who had to discontinue, like the rest of the drugs. So a large armamentarium for anti-psychotics is more important than, say, adding another statin or non-sedating anti-histamine to the market.

By the way, I wouldn't lose too much sleep (har har!) if I worked at AstraZeneca, makers of the maligned Seroquel (maligned in this article, at least). The drug is the market leader in prescriptions, but not sales. Why? Because most of the use is for sedation ("Sleepoquel") at sub-therapeutic doses. Let's just hope they aren't promoting it that way. T'would be bad.

Gardening away
Yep, the movie was awesome. I also watched City of God recently, by the same director, and found it somewhat over-rated. But watch this space in December for shameless promotion of "The Constant Gardner" for Oscar consideration. I cried like three times.

Interesting note - check out this post on essentialdrugs.org, concerning the movie poster. Kind of bizarre. I was struck by the fact that Ralph Fiennes appears with an outstretched arm holding a gun on the movie poster, which never occurs in the film. Also, in the movie's trailer, there's clearly a scene that was set in a snowy area, presumably in Western Canada, where part of the book is set. This is also not in the film.

Morning After Post

2005-08-27T04:44:00.000-07:00

I wan't going to post this weekend, but I found myself with some free time this morning, and decided to go with Plan B, while hunched Over-the-Counter in my kitchen. I just couldn't justify delaying this any longer, you dig?

Focus on Medicare

I got to take a little break from my cube and computer last week to participate in a focus group on Medicare Part D. It was the second time I had been invited to do so in my Company, and I was eager to voice my opinion. This time, we were being asked to evaluate educational materials for both patients and employees. The idea is that we as employees may be asked by patients what it's all about, and we should be knowledgable.

But first, we got to sound off on the program as a whole, and my fellow employees did not let me down. No myrmidons we, many negative opinions were expressed. I spoke about how the complexity of the program was a direct result of our lobbying against any kind of single payer system, while others worried about the liability of Medicare, especially after I pointed out that it will be insolvent far sooner than Social Security. The Public Affairs guys and gals in the back of the room took notes. I don't know if they were expecting this.

I have not missed an opportunity to say something about Part D whenever I could, and truthfully, I've never felt uncomfortable expressing anti-industry opinions in forums such as this. My company has one of the lowest rates of employee contribution to PACs in the industry, so I like to think that there's a lot of independent thinking going on here.

Still I remain vigilant. I've heard people complain about Medicare Part D in terms of its complexity - it's usually something like "God---ned government can't do anything right. Why do they make my mother/father/relative shop around for these ridiculous cards?" I don't hesitate (and neither should you, loyal reader(s)) to enlighten that person. It was us. We caused it to be like that. Without those cards, without the shopping around, without the explicit prohibition of government price setting like the Veterans Administration has, the program would not exist. We simply wouldn't allow it. After all, you are only citizens, and we write your laws for you.

Constant Gardener

2005-08-25T19:03:00.000-07:00

I am pleased to announce that I have just finshed John Le Carre's novel The Constant Gardener, just in time for the film's release next Wednesday. Fortunately, it's supposed to be a "wide release," meaning that it should come to my local multiplex, so I don't have to go to the Big City to see it. Don't get me wrong - I love the Big City, but when you're paying a babysitter $10/hour, you don't want to spend two of those hours driving to and from your destination.

I'm not sure how the book escaped my attention before now, since I have a growing library of anti-Pharma tomes. But I enjoyed it much more than Kakutani did. But whenever a reviewer complains that a book "devolves into an altogether conventional thriller" one should remember that the reviewer reads these things for a living. I don't, so the "conventional" part simply didn't apply. I reserve that sort of criticism for my Ebert moments, where I'm on surer footing.

The Author's Note at the end makes Le Carre's contempt for Pharma clear. He urges the reader to investigate a German outfit called BUKO Pharma-Kampagne, which is an independently financed Pharma watchdog group. Not in the Public Interest vein, but rather focused on the perfidy of Pharma's dealings in the developing world. Read about them here.

You're sick! You Spend too Much for it! You get little!

2005-07-12T16:39:00.000-07:00

First, a letter to the editor of the Wall Street Journal, commenting on the Viagra vision loss article (notice how I've tastefully avoided conflating Viagra use, blindness, and certain habits, just for a cheap laugh!) that I noted last week.

...as a consequence of our legal environment, drug companies have no choice but
to cram onto drug labels every adverse reaction reported, no matter how
rare....If a single adverse reaction has been reported and isn't included on the
label, the company will likely find itself on the losing end if sued by a
consumer who experiences that adverse reaction, on the theory that the company
''failed to warn'' of the remote risk of injury.

Sounds familiar, no?

You're sick!

What a great article that appears in the Seattle Times recently! As the introduction states,

Pharmaceutical firms have commandeered the process by which diseases are
defined. Many decision makers at the World Health Organization, the U.S.
National Institutes of Health and some of America's most prestigious medical
societies take money from the drug companies and then promote the industry's
agenda.

Damn right we have! Because we have the money to do it!
Check out the homepage of this excellent series, and spend some time reading the articles therein.

More ideas about DTC restrictions

2005-07-08T18:45:00.000-07:00

NPR and drug advertising

Because I know my readers have too much free time (after all, how else did they find this site?) I would urge you to listen to this NPR program, "Justice Talking" which was an hour-long debate about drug approvals. The show aired last Spring, during Pharmablogger's hiatus. But nothing escapes my attention!
The debate was actually quite tame. Schering-Plough Chief Medical Officer Dr Bob Spiegel squared off against Dr Alastair Wood, of Vanderbilt and the NEJM. Dr Wood was far more reserved in his comments than Marcia Angell of Mr Goozner would have been. He defended profit motive as a driver for new drugs, and does not think they are approved too quickly. However, his remarks about post-marketing surveillance incentives were interesting. He would tie approval for Direct to Consumer (DTC) advertising, as well as exclusive formulary listing, to completion of Phase IV safety studies. He also acknowledges the 1st amendment issues, however. I thought this tied in nicely to the previous post about Bill Frist's DTC suggestions.

Economics and Health
Right on the heels of that article about pill-splitting being endorsed by insurers, we learn one of the largest pharmacy benefit managers, Express Scripts, has reported no cost increases from 2004 for companies and organizations that utilized a step program for prescriptions. The step programs consist of using older, less expensive and usually generic drugs before stepping up to newer, more expensive therapies. The article is from Managed Care Weekly, with no link available. No year-to-year cost increases? Hello, GM? Anyone home?

The Written Word, DIA, and WLF

2005-07-05T18:24:00.000-07:00

Warnings for the eyes?

I'll start this evening with an excerpt from the Wall Street Journal. I haven't a link, since it's a pay site. Suffice to say that it's the best newspaper in the world, and I highly recommend a subscription to anyone.

Amid recent worries that some impotence drugs could be associated with vision loss in rare cases, there were predictable suggestions that this information be added to the pills' instructions....But the directions, also called package inserts or labels, have become so bloated and poorly organized that
they often obscure the facts that would be most useful....A government
proposal to make the labels more useful has been in the works since 2000,
long before the recent controversies over safety problems with
antidepressants and arthritis drugs. ''We are working on a final rule now
and don't have a time frame at this point for its completion,'' an agency
spokeswoman said.

The notorious package insert. Long, tedious, meaningless? This article is important, because it clearly describes who the insert is written for - lawyers. It's a giant CYA, with contradictory messages. If the company neglects to put something in the label that they have data for, it's a warning defect, in legalese. But regardless of what they put in, they always preface the list of nasty effects with "regardless causality." So, we've warned you, but we're not saying if we think our drug did it. What a ridiculous method of trying communicate important information to physicians.

Frist vs the WLF?

Bill Frist has gone on record urging drug companies to refrain from DTC in the first two years of a drug's life in the market.

Frist warned that the flurry of consumer advertising that often accompanies
launches of new drugs can lead to inappropriate prescribing and unnecessary
health care spending. He said he is asking the Government Accountability Office
(GAO) to review the Food and Drug Administration's oversight of prescription
drug ads, the drug industry's drug ad spending, and its effect on drug
utilization and health care spending.

This is slightly astonishing, and quite welcome. The last Senator we heard discussing the dangers of DTC was Kennedy. Frist also questioned DTC's role in overprescribing, with deleterious health consequences. Clearly, Frist has wandered off the reservation here, as the article continues to give an opposing viewpoint from PHARMA. Again, no link here, as this was taken from an article from the Bureau of National Affairs, and you need an expensive subscription. DTC is absolutely huge in the first few months of a drug's lifecycle, because everyone is looking at the sales curve for the launch period. The sharpest uptick is always in the first year, and if you don't get the utilization you want during that period, you might never.

But wait, Bill - your Republican anti-trial lawyer free speech buddies probably don't agree with you! According the Washington Times, and the Washington Legal Foundation's own website, DDMAC is already violating the law when it comes to regulating the "free speech" of drug advertising. I admit that DDMAC can be somewhat capricious with these DTC matters. I've got a good story about that, for another time. But the WLF clearly wants to pave the way for drug companies to say whatever they want about their drugs, without any interference, as a matter of right under the First Amendment. I've said it before - my copy of the Constitution and Bill of Rights keeps talking about people, and doesn't contain the word "corporation" or "company" in it. In fact, there's only one reference to "property" at all, and it's the government's property. Where's a strict constructionist when you need one?

An Autism retort, and BS at the WSJ

2005-06-25T06:49:00.000-07:00

I previously wished aloud that someone other than RFK Jr write about autism and thimerosal, and I seem to have gotten my wish.

I don't wish to dwell on this issue long, but check out the New York Times today, with an examination of some of the personalities and seminal studies on autism. Near the end of the article, a researcher make the excellent point that regardless of the studies, we will know about the thimerosal-autism conclusively in two years, because that's when the first cases of post-thimerosal autism will be diagnosed. The question is, how many will there be?

Outrage of the Week
OOOOOOOOh, we're hot about this one. OpinionJournal online has a ridiculous screed from "a Boston Lawyer" (corporate defense, shall we assume?) about prosecutorial abuse of the US Attorney's office in Boston, against drug companies. Now that he's written a piece defending TAP, he's signed on board the Saddam Hussein defense team.

Seriously, though, there is no defense for TAP. They didn't even try to make one. In a typical bait-and-switch technique, he uses the acquittals of some unnamed TAP officials as vindication of the company as a whole. He also suggests that the qui tam payout of the whistleblower somehow undermines the legitimacy of the case. Fortunately, there's a public record here that can't be ignored - the US Attorney's settlement with TAP, with all of the salacious details of fraud contained therein. Remember, these guys cost you, the American taxpaper, hundreds of millions of dollars. I have a copy if you can't find it online - email me if you want it.

Here's a nice summary of qui tam suits, with specific information about the TAP and AstraZeneca cases, at cafepharma. We also found this article, by a defense attorney for one of the TAP officials, who also use the acquittals as a means to question the whole prosecution. What is especially appalling is that Pharmaceutical Executive would have even published his article. This is just the message we want our executives to hear, isn't it?

There's also mention of AstraZeneca in the OpinionJournal piece, which got in similar trouble with their Zoladex injections. Fortunately for them, their malfeasance was not nearly as grand (they actually had a legal department, unlike TAP, who referred to it as the "anti-profit" department). I haven't heard anyone at that company crying foul over prosecutorial zeal. I just wonder if all of the thousands of employees who now receive mandatory ethics training as a result of their company's settlement have any idea why that's happening.

Folks, fraud is fraud, regardless of what Medicare policies you object to, or how you feel about prosecutors in general. Don't try to change the facts by dressing up your objections in ideology.

An American Wannsee?

2005-06-20T18:59:00.000-07:00

RFK Jr - investigative journalist?

If you've been wondering why I haven't written about the Autism and Thimerosal article in last Thursday's Salon.com, wonder no further. I've been taking the time to research the article, so I could comment competently.

And what I've found is disappointing, given the topic and the article's hype.

Read it here, rather than Salon, so you don't have to sit through a commercial. Your first impression may match mine - a conspiratorial approach that reads like a paranoid thriller. But you can read the original conference transcript here for yourself.

What? You don't want to read a 268 page .pdf file? Why not??

Fine - here's what I found. Some of what RFK Jr wrote is simply bunk. This was a large conference, over 50 participants, held in run-of-the-mill conference center a few miles outside of Atlanta, because that's where the Centers for Disease Control and Prevention (CDC) is. There was a technology conference in the city, which apparently occupied all of the available space there, according to the organizers.

No notes or materials allowed to leave? Nonsense. Check out the request from one of the participants to get copies of slides for everyone, and the half-hearted request at the end for everyone to embargo their materials until the end of that month, when they would be made public.

But the most telling thing about this transcript is simply that it has been available on the web since November 2003. All of the other "references" that RFK Jr make are out there as well, some of it years old. The quotes that he picked out are the same quotes from an article at momsonamissionforautism.org, also dated 2003. Search for the quotes, particularly the "plaintiff" ones in the .pdf file, and you'll find that the participants who spoke them were hardly being surreptitious.

This was an RFK clip job, and not a good one.

Why oh why did he have to write this? Sure, the democraticunderground.com loves it, but this should have been written some time ago, by a real journalist, in somewhat less inflammatory tones.

Why? Because the story itself is real. Epidemiology matters! (What a great bumper sticker that would make!)

As my friends at Breast Cancer Action like to point out, the quest for cures is only part of the story, and perhaps not even the most compelling. But the rising incidence of autism has been so ridiculously dramatic over the last 15 years, that no one involved has missed it. This point is missed by the pink ribbon bunch, who ignore the doubling of breast cancer incidence in the last few decades, but that's another story.

I've blasted this article here, but I cannot urge you enough to read more on this topic. You may have read that Bill Frist is trying to attach a rider to a homeland security bill to give legal immunity to vaccine manufacturers, or that ABC tanked a story on RFK and Autism. I suppose if his article gains the issue some attention, than it's all for the good. Again, I just wish a real journalist, who knows how to attribute, had written it first.

Some fun this evening

2005-06-17T18:50:00.000-07:00

First, I want to announce my abandonment of the first person plural. It's become obnoxious, derivative, and difficult to maintain. I may be adjusting previous blogs at some point in an Orwellian attempt to change history. While a couple of my favorite blogs are written that way, it's simply not my style.

The Future of Pharmaceutical Marketing?

An advert for this product appeared one recent Sunday morning in my paper, and I almost choked on my Hazelnut decaf.

I had fun calling a friend who works for McNeil Consumer Products, and he confirmed that the company is sliding down a steep cliff of intellectual bankruptcy. This is the company that brought us Tylenol ER, which was a coat-core Tylenol that lasted eight hours. It didn't sell, but their market research told them that anything with the word "Arthritis" in it would. So the same product was relaunched as "Tylenol Arthritis." The results were spectacular.

With flavored medication as inspiration, I had a few new ideas of my own. I wonder if they might take hold?

The Zoloft Happy Meal!

Some Ambien in your decaffeinated soda?

Idiocy at CBS!

2005-06-16T19:28:00.000-07:00

WE promised you this post yesterday, but we missed our deadline. But dammit, Batman came out yesterday! Two BIG thumbs up here!

Against What Grain?
First, start with this article from CBS News writer Dick Meyer, published in February.

The article was sent to us from a well-meaning colleague at work, who was excited to read something positive about pharmas. We almost blew a gasket reading this. No, we DID blow a gasket, and replied to our colleague with the following verbatim text, copying the four others in our department who also received the initial email:

My impressions of the article, blog-style.
"We expect drug companies to be altruistic, not to be motivated by profits...I don't think they are more or less greedy or corrupt than companies in any other sector of the economy."
Why would we expect drug companies to be altruistic, a cut above other types of corporations? Because that's the image they are giving us, through their company branding adverts. They are actively selling themselves as the deliverers of a better life, with mission statements that sound like something written for the WHO. In fact, they have a fiduciary duty to maximize return to shareholders above all else, a point that is painfully clear to AstraZeneca, considering the wave of class-action suits being filed against us: see http://www.lerachlaw.com/cases/astrazeneca/complaint.pdf
"I don't think they are more or less greedy or corrupt than companies in any other sector of the economy...And just because they make medicine, their malfeasances are not quantitively more evil than those of other corporate evildoers."
Is this guy kidding? Pharma malfeasance kills people. How many people died as a result of Enron, Global Crossing, MCI/Worldcom, Arthur Andersen, etc?
"Personally, I am incredibly thankful for drug companies. People I care about deeply are alive and full-strength because of drug companies."
How about some recognition for the NIH or NCI? Others have spent many electrons and killed many trees discussing Pharma perfidy in claiming medical advances; I shall not attempt to duplicate them here. One example only: http://lists.essential.org/pipermail/pharm-policy/2000-June/000215.html
"When more people use more effective drugs, overall health spending costs are lessened and national productivity goes up enormously, but in incalculable ways." Correct. But what is being prescribed? The ALLHAT trial http://allhat.sph.uth.tmc.edu/ clearly demonstrated the wastefulness of current prescribing habits for hypertension, to give one example. I have personal experience with this - when my wife was initially diagnosed with postpartum hypertension, our family doc reached for his prescription pad, and gave her a script for a (under patent) calcium channel blocker. We "fired" that pharma bimbo asap. For something closer to home, see: http://www.prescriptionaccesslitigation.org/resource.php?doc_id=662
"Critics don't want drug companies to advertise like other companies. They say the money should be spent to make drugs cheaper, which is a bogus point."
Classic strawman argument. How the heck does this guy know what critics are thinking? Basic economics shows that (successful) DTC doesn't raise the price of individual drugs - it pays for itself through higher sales volume. But at what price? Are the most effective treatments being advertised, or just the newest and most expensive? Are physicians prepared to discuss with their patients why they prefer to prescribe X instead of Y, when the patient insists on Y because she saw a lady with arthritis dancing around on TV? See: http://www.jabfp.org/cgi/content/full/16/6/513. - from study article: "Physicians filled 69% of requests they deemed clinically inappropriate"
"When a patient uses an expensive prescription drug for heartburn when a cheap over-the-counter might work just as well, we blame the drug company. But isn't the doctor more or equally responsible?"
Absolutely the physician is partly responsible, but they work within an irrational system. They continue to prescribe Nexium when Prilosec OTC is just as good, because they know that the insurance won't pay for the OTC.
"But the decisions about how medical care is distributed in this country are our decisions, collectively, through elections, laws and government...It is only by a spectacular feat of cynicism that our political system's moral negligence has become the fault of the pharmaceutical industry," Gladwell wrote in 'The New Yorker.'"
Again, is this guy for real? An investigative journalist? Has he read the Medicare Modernization Act, and seen the provisions that were inserted DIRECTLY FOR PHARMA that prohibit price competition, like the VHA enjoys (again, only one example)? Does any other industry have the benefits bestowed upon pharma by Congress? Has he checked to see what industry is the largest political contributor in the US?

Damn, we loved that reply! We wrote it all in a fury, with the links, in about 15 minutes. After we sent it, we panicked, and followed-up with another email begging the recipients to PLEASE not forward the message to anyone else. Brilliant analysis, perhaps, but lousy judgment. We also sent a copy to Dick Meyer, who replied with a polite Thank You. We had every intention of blogging this article at the time, but events intervened.

Save those links. Impress your friends and relations. Ciao.

Ethical Blinders

2005-06-14T18:06:00.000-07:00

Good evening, class!

Book report project
Today we start off with an assignment for a new book that doesn't quite cast the drug company in such demonic lights, as have our previous assignments. It's more illustrative of the powerful personalities who dwell at the summit of medical research and business. Mild personalities simply don't reach these spectacular heights, which explains why we are plugging away at this blog anonymously, while we should be doing other mundane tasks.

Such a clash is illustrated in a new book, reviewed here in the Times, describing how one alleged scandal over drug safety morphed into an altogether different affair surrounding the principal investigator for a Canadian drug, Nancy Olivieri (described as "charismatic"), her attempts to whistleblow the company supporting her, and why it may have all been smoke and mirrors. Not available in the US yet, so far as we can tell.

Pill splitting backed by insurers
The Associated Press has a interesting story, found in today's Philadelphia Inquirer, about how pill splitting to save money is being encouraged by insurers. If multiple dose forms are priced similarly, and there are no issues with instability or coat-core formulations, why not get a higher prescription strength Lipitor than you need, and cut it in half?

Ethical blinders?
It was the last sentence in this article that grabbed our attention. We got most of the way through this thinking that a CME "wall of separation" between pharmas and docs may be possible someday, if these trends continue. But then the Cephalon spokeswoman has to go ahead and say something stupid like "...it's an opportunity for us as a company to start building a presence in psychiatry" while discussing the psychiatry course they are underwriting.

If she's reading this (hah!), she probably has no idea what we are objecting to. Therein lies the problem.

We've had many a conversation with sales folks (who have a much more difficult job than we) about influence over physician prescribing habits. VERY little is required to make one person feel some kind of indebtedness to another, when it comes to gift giving. Pharmas know that well. Even the merest office trinkets, or under $25 "lunch and learns" can influence a doc to mke a decision they would not ordinarily make. See this link for the statistics involved. The reps we have known talk about building their relationship with physicians, often becoming quite chummy. And the kicker - they honestly, in their gut, think that is perfectly OK. Why not? Salesmen from other industries certainly get that way with clients.

Do we need to write more, or are you getting it? Would you like to know all of the factors that went into the decision for your doc to write you an Rx for drug xyz? And would you be comfortable knowing that the sales "relationship" was a factor, however background it may be?

The reps, the Cephalon spokesbabe, the docs - all with moral blinders. Is it immoral when they don't even see the conflict? Why is anything besides science guiding medical decision-making here? After all, every company claims that each of their products is the superior product for clinical reasons. Let's make them back that up without the relationships.

Tomorrow: The article that almost brought us out of retirement last February.

Pharmablogger Returns!

2005-06-09T19:03:00.000-07:00

Good evening, and welcome back to all of our loyal reader(s)! (Mom!!)

The news is just too rich too stay away. Let's start with our friend from Pfizer, Veep Peter Rost, recently profiled in this New York Times piece. It seems that Dr Rost is given precious little to do these days at Pfizer, after mouthing off about the truth of pharmaceutical marketing. He even reads some of the same books that we do! So why not fire him? Well, there's the possibility of Pfizer violating an anti-whistleblower statute.... Read the piece for more. Today. It's already a few days old, and the Times doesn't let you access the articles for very long.

Then we have our always reliable friends at Merck, who are responsible for two great pieces relating to Vioxx, and the pressure they place on researchers not to speak evil of their blockbuster. Start with this article from the Philadelphia Inquirer to get a taste of what kind of pressure they can exert. Than get a fuller picture from this piece from NPR's All Things Considered.

NPR got hold of documents that were obtained through some kind of discovery process at Merck. The New York times has done the same for Johnson & Johnson, to write this article about Propulsid. Let's focus on this sentence: "An internal company memo examined 15 of the proposed label changes and estimated that they would cost over $250 million a year in lost sales." That's just for a label change that many doctors will ignore anyway, continuing to prescribe off-label for the kiddies. No more need be said there.

There is a reference in the article to a film called "MAMA/M.A.M.A.," by Nonny de la PeÃ±a, which we have not seen. It's apparently about Munchausen Syndrome by Proxy disease. As a service, we will look into this film more. That's a particularly bizarre syndrome that we've read about in MedWatch reports for certain psychoactive meds we work with.

But we digress. After reading the Inquirer piece, like always our reaction began with "How appalling!" to "Gee, we wonder if we've ever done that?" Frankly, we have no idea. And no belief that we would ever find the truth about our company, absent a lawsuit with leaked documents.

Malpractice shield redux

2005-01-05T13:52:00.000-08:00

We discussed in an earlier post the possibility of Congress passing a tort reform bill that included a shield bor pharmaceutical companies who had complied with FDA regulations. Providence has given us spate of FDA deficiencies in the media that will help to prevent that bill from passing, but it already exists in at least two states - Michigan and Texas.

Today's Houston Chronicle discusses how Vioxx lawsuits in Texas may likely go nowhere, thanks to year-old tort reform legislation that protects drug companies "...as they can prove that any warnings of harmful side effects were approved by the Food & Drug Administration."

"To win against Merck in Texas, Vioxx plaintiffs will have to prove that the company withheld information or misrepresented it to the government. That will make litigation so expensive, some lawyers said, that they will accept only serious cases, in which plaintiffs were badly harmed and damage awards could be high. "

There is a possibility of combining the hundreds or thousands of Texas suits with suits from other states by the federal Judicial Panel on Multidistrict Litigation in Washington. This may be in Merck's favor however, as the litigation will become increasingly complex, and timelines will be stretched out for years. Remember, corporations may be "legal artificial persons" under the law, but they have the distinct advantage of not needing to age or die, unlike many of the "natural person" plaintiffs.

Here is a Law.com article about the other state with this protection, Michigan. Their law was passed in 1995, and withstood appeals to the Michigan Supreme Court.

"Jim O'Reilly, law professor at the University of Cincinnati and author of treatises on the FDA and product warnings, said the Michigan statute is unusual because states do not usually cede power to the federal government without pre-emption. A former associate general counsel at Procter & Gamble, O'Reilly added, 'the state is deciding to give away the rights of the individual" so that career federal agency employees in Washington "are now exercising the delegated power of a jury.'"

Jeff Trewhitt, spokesdude for PHRMA says that "the association has long supported an "FDA defense" to punitive damages if a drug company can prove that it followed all of the agency's rules and regulations in good faith." But frankly, even this is crap. The reality is that drug companies have to prove nothing. The plaintiffs will have to go through ridiculous amounts of discovery to prove that the drug companies did not follow regs in good faith. Do you know how much meaningless paper and garbled statistics a company can dump on a plaintiff to make discovery an impossible journey? We do. We've been instructed to hold all papers, emails, etc. with the name of certain drugs on it, in case of expected future litigation. We'll be able to bury any plaintiff with mountains of paper, should they dare to ask for it.

In today's mandatory Washington Post article on the subject of tort reform, pinhead "Victor E. Schwartz of the American Tort Reform Association. "If you have done everything the law requires, why should you be punished?" Victor missed the part in Torts class concerning the Common Law, and that regulations make up a tiny amount of what we call "the law." Let's just stuff the regulatory agencies with business people who don't care about patients or consumers, and then give those agencies the burden of deciding when the businesses subject to their regs can or cannot be found liable.

No thanks. The jury system can be found in the Constitution, while FDA deciding what is legally liable is not. Just call me a strict constructionist!

Robert Reich is ahead of Pharmahost

2005-01-03T20:57:00.000-08:00

Yes indeed, we must give credit to Mr Reich, who writes for the American Prospect. In his article about the perverted juxtaposition of tort reform for companies who follow FDA regs for their products, and the poor quality of FDA oversight at the office of Drug Safety, Mr Reich echoed my blog of December 27 ("Pfizer Exec tells all"). Except that he wrote his article on the 22nd. Like John Kerry, we have written to the American Prospect to offer our concession. And to ask that they link to Pharmablogger. T.A.P. ROCKS!!

For a different tale of Drug Safety, we offer you a link to an article in The New Yorker concerning the testing of drug in pediatric populations. The article is long, and makes several important points. We would like to focus on the idea that any drug under consideration for approval should be highly scrutinized in vulnerable populations for safety, and indeed we have seen this for the hepatically impaired in recent years. Liver failure has been one of the most common reasons for drug withdrawals or non-approvals (see Duract and Exanta). The Duract example is good because no one could get doctors to stop over-prescribing that drug. You have to wonder, does a company in that position really try to get a warning message across, right down at the sales rep level, even when the FDA is breathing down their necks?

Anyway, we would expect that real pediatric studies would be expected for whoever brings forth the next anti-depressant, based on recent bad publicity of Paxil and other SSRIs (studies in which no one actually committed suicide, but had events coded to the term "suicidal ideation"). This is still a scattershot approach, however. Scrutiny will only be brought to bear on the categories of drugs that have already been demonstrated to be a hazard.

Lastly, for our daily dose of re-importation nonsense, see this article from CIPA, a Canadian mail-order pharmacy group, that contends President Bush is behind a new effort by the Health Ministry to shut down shipments to US addresses. We love the way they make us sound like an underprivileged country in this bit:

"Dosanjh (health minister) drafted the new regulations that, if implemented,will make it illegal for Canadian mail-order pharmacies to fill prescriptions for non-citizens, and leave millions of Americans without access to affordable medications."

Oh wait, I forgot. For health care coverage, we ARE a third world country.

Re-importation - time to take sides?

2004-12-31T08:06:00.000-08:00

Not so much on the drug safety issue recently in the press. Instead, we have found several pieces relating to re-importation from Canada.

The Washington Post has an article by financial writer Steven Pearlstein that blasts the recent Bush Administration report on drug prices. Among other things, it asks the simple question, if you defend our prices on the idea that they help subsidize R&D for the world, then should why should there be any policy to help lower drug prices?

Rhode Island became the latest state to approve re-importation of drugs from Canada. The testimony for the state Health Department included a reference to the USA Today article that described greater reluctance on the part of Canadians, including Health Minister Ujjal Dosanjh, to subsidize our drug bill. Apparently, when drug re-importation becomes a matter of state policy rather than an individual act, there is puch-back from the suppliers.

We have actually been eagerly awaiting this development, since push-back from Canada will force lawmakers to stop trying to placate the few loudest grey-haired types, and find a way to give us all real relief from this industry boot on our throats.

Anybody notice that the $35 million aid package announced by Colin Powell is $5 million less than the Republicans are planning to spend on inaugeral festivities?

Please take a moment to lend a hand to those who are suffering from the tsunami. We think that the extent of this tragedy may not be known for quite some time, and the death tolls updated daily on the news are gross under-representations. You can donate here or here.

We hope your new year is healthy, and may you have unlimited access to your pain control of choice. We will be spending the evening with friends in an orgy of fondue and fellowship. May your evening be safe and enjoyable.

Pfizer exec tells all! and Fraud on the FDA?

2004-12-27T08:11:00.000-08:00

Today we found a remarkable story in Sunday's Los Angeles Times (link may require free registration), written by Peter Rost, VP of marketing at Pfizer. We urge you to read the entire piece, but we'd like to point out a few items that caught our eye. For instance:

"A 2001 study by the consumer advocacy group Public Citizen found that drug companies' favorite customers paid just a little over half the retail price. This leaves the 67 million Americans without insurance to pay cash, with no rebates, at double the prices paid by the most-favored customer"

Most drug company execs would piss on any report created by Public Citizen, like this one that discusses the real cost of drug development. We find Public Citizen's quest to have every objectionable drug banned to be irritating, because they refuse to acknowledge the real-world benefits that some patients have with newer drugs like Celebrex, after the patient has failed older therapies that Public Citizen approves of. While aggregate efficacy is compelling, and older therapies should always be tried first, there are always outliers that have fantastic responses to new therapies, and their health should be considered, too.

But we digress. To find a Pfizer exec quoting Public Citizen is remarkable. To read him also dissing Pharma indigent programs, like he does two paragraphs later, is stunning: "If they really worked, the Kaiser Family Foundation wouldn't have reported that 15% of uninsured children and 28% of uninsured adults had gone without prescription medication in 2000 because of cost, and 87% of uninsured individuals with serious health problems reported trouble obtaining medication." Wow.

So, how far off the reservation is Mr. Rost? At Pharmablogger, we have no clue. We assume that marketing execs (we don't know any personally) come from the ranks of sales reps, and they generally have drowned in the Pharma Kool-Aid. Yet, we know several high-ranking drug development types who believe that dramatically lower prices will bring about much greater utilization, since there are so many under-medicated patients out there. Hard to believe, since Grandma seems to be popping her pills all day? It's true, though. So many people with untreated hypertension and hyperlipidemia, for example. That's why firms continue to get into these markets with me-too drugs - their advertising is designed not only to take away market share from competitors, but to get more people to have themselves examined for these conditions, and expand the market for everyone.

We would like to examine the issue of Fraud on the FDA in this space today, since we were prompted by an article on tort reform in the Philadelphia Inquirer. The article details the attempt to create tort immunity for Pharma firms whose drugs have passed FDA approval, and have met other "FDA standards." A Merck spokesman states that they support the proposal.

"Proponents of the bill and the pharmaceutical industry have contended that manufacturers should not have to pay punitive damages for an FDA-approved product unless it can be shown that they misled the agency or failed to follow FDA strictures."

What's the problem here? Several. This bill assumes a competent FDA, for example. We generally approve of the job the FDA does, but it is incredibly understaffed, particularly in the post-marketing surveillance area. So if the FDA fails to act on a drug that has several safety "signals" - warning signs, why should the manufacturer get a free pass for this? There isn't any comparable protection in other industries, as far as we can tell. The Consumer Product Safety Commission issues a number of recalls every year, for example. So any product that is not recalled should be held unaccountable for design flaws? Nonsense.

This also assumes that the Pharmas are fully diligent in reporting to the FDA all safety signals that it finds. Assuming that they're looking. In fact, this bill would encourage them to not look for safety problems in their data.

That leads us to Fraud on the FDA. This is a claim that was asserted in a seminal medical device case called Buckman Co. v. Plaintiffs' Legal Committee, 121 S.Ct. 1012, 148 L.Ed.2d 854, (U.S. 2001). The Supreme Court rejected the idea that there is a private action possible against companies regulated by the FDA (including device firms) for state-law fraud on the FDA cases.

"The conflict here stems from the fact that the federal statutory scheme amply empowers the FDA to punish and deter fraud against the Agency, and the Agency uses this authority to achieve a delicate balance of statutory objectives that can be skewed by allowing state-law fraud-on-the-FDA claims. "

So, you can't sue Merck on a claim that states that they defrauded the FDA by failing to provide timely safety data for Vioxx, for example. Perhaps Merck isn't the best example. How about the makers of Phen-fen, who actually stuffed safety reports in desk drawers concerning lung and heart problems? If the FDA fails to act against the manufacturers, and then this "tort reform" is passed, what kind of claim is left for those who have been harmed? Remember, the FDA has a "delicate balance of statutory objectives," only one of which is patient safety. The others are more like industry promotion. These can and do conflict, which was at the heart of David Graham's testimony.

There is an attempt to get around the Buckman ruling, by stating that a drug is not really approved if there was fraud in the approval process, thereby abrogating the FDA's right to punish fraud, since a drug or device should never have been approved to begin with. This is the Gilligan case in the Sixth District, but we are not optimistic. The same rationale in Buckman could be used here as well to shoot down this theory.

Lastly, we have a stark reminder of what we posted in the inaugural edition of Pharmablogger - that Pharma is first and foremost a business, with a fiduciary responsibility to maximize return to investors. Tom McKillop of AstraZeneca is learning that right now.

Michael Moore attacks; and first Archive Holiday Assignment!

2004-12-23T10:58:00.000-08:00

Rotton Tomato news has a story about Michael Moore's forthcoming film "Sicko" which will be about American Health Care, possibly focusing specifically on our wonderful industry. The story notes that some companies sent out a warning to employees concerning the film, and to watch out for Michael Moore ambushes at the gates. We can attest that this is true - our company made such a warning earlier this Fall. My opinion about Michael Moore's films can be found in the comments beneath the article, and I won't repeat them here. Look for the Pharmablogger comment.

Little other news today, except for the bitch-slapping warning letter to AstraZeneca concerning their face-saving adverts for Crestor that appeared shortly after David Graham fingered the drug as one of five potential Vioxx cases. Here's the New York Times take on the letter, where they pull no punches in listing other AstraZeneca woes of the recent past.

We are not sure how often we will post in the coming few days, due to Christmas. For your holiday reading pleasure, I am assigning an article that appeared in the Times in March, 2001. The article is about the development of Claritin by Schering Plough, and their attempt to prolong the brand patent. Normally, the Times charges for access to articles over 7 days old. But for special features like this or Magazine articles, free access appears to be indefinite. The crux of the article is that so much money has been spent, and so much litigation has taken place over a drug that barely beat placebos in the efficacy trials. We just take a little piece of a Benadryl when we need something for our Spring allergies. Remember - there's no such thing as a non-sedating anti-histamine. By definition, any drugs that block histamine receptors (including many neuroleptics) cause drowsiness. Claritin, Allegra et al are simple weak anti-histamines. And our allergies laugh at them.

Update 2 hours later: Check out this article in Editor & Publisher about the Michael Moore film. Hidden cameras in doctor's offices? This could get ugly. We once had a discussion about doctors with a sales rep, who insisted that "establishing a relationship" with a doctor by providing dinner and other goodies was good for everyone, including patients. These Kool-Aid drinkers cannot ever see their role as corrupters of good medical practice. When our wife (first-person plural gets difficult sometimes) was diagnosed with post-partum hypertension, and the doctor's first choice for a prescription was a Calcium Channel Blocker, we "fired" that doctor immediately. Sometimes, it's hard to tell who is worse - the doctor whore, or the sales rep pimp.

Merry Christmas and good health to all!

A correction; and healthy skepticism at last!

2004-12-22T06:48:00.000-08:00

Yesterday we posited the idea that there was a media script for the "confused consumer" who did not know how to handle the news about Vioxx, Celebrex, Naproxen, etc. We are happy to say that we are wrong about this, as the script has been revised along lines we approve, namely the pissed off consumer.

We saw in yesterday's Wall Street Journal an article (free to subscribers only) about people with pain who were not happy about having the option to weigh risks versus benefits taken out of their hands. Similarly, while listening to NPR's Talk of the Nation, we heard John Klippel (heading of "Treating Pain"), president and CEO of the Arthritis Foundation, make the same case. OK, the Arthritis Foundation Supporters Page clearly shows that it's in Pharmas pocket. Still, a broken clock is right twice daily (cliche watch).

An article in today's New York Times shows us some healthy skepticism from members of Congress, particularly Republican, concerning the results of the Bush Administration's study on the safety of drug re-importation. Really, where do people think those Canadian drugs come from, anyway? And what would they find if they performed the same kind of study on drugs processed through the world's largest "repackaging" facility in Bentonville Arkansas (guess for whom?). If they don't take the Administration seriously on this, why did they swallow the $400 million pricetag for the Medicare Modernization Act (drug bill)?

On the subject of drug safety and the FDA's role in policing, I want to recommend Philip Hilts' history, Protecting America's Health. As I state in my Amazon reading list, while reading about the patent medicine era, consider how many conservatives/libertarians want us to return to those days, having the marketplace weed out the bad actors and products, after we can no longer ignore the bodies piling up on the streets.

Shop happy. I hate slamming into annoyed people in the mall.

Oh the PAIN! Celebrex, Naproxen, Accupuncture?

2004-12-21T06:57:00.000-08:00

Naproxen is next on the block, with evidence that it may also contribute to cardiovascular problems. The consumer reaction that we hear from the media does not juve with our personal experience, however. That's because there's a media script here, and they only feature people who fit the part - the Confused Pain-Sufferer!

Bollocks, to use a great British term. Don't you think the average consumer can understand the difference between a 1 in 1000 chance of having a heart attack or stroke versus a 2.5 in 1000 chance? That's the difference between Vioxx users and non-users. Now, we know that in the aggregate data, there is no efficacy difference between COX-2s and NSAIDS. But this is the type of medicine that has unpredictable outcomes for individual patients. I'd like Syney Wolfe to go to our mother's house, and tell her that she doesn't really need her Vioxx for her crippling rheumatoid arthritis, despite the fact that NSAIDS clearly did nothing for her after many years of use. How do you explain someone taking their first few doses of Vioxx, and shortly thereafter feeling a freedom of movement that they haven't had in years? Placebo effect? Bollocks again!

We're picturing a new drug ring in this country, a gang of little old stooped-over ladies (shades of Monty Python here) who traffic in COX-2s, and get pissed off whenever a consumer activitist tries to tell them what's best for them. Wolfie's gonna be found face down in a pool of Ensure someday, knitting needles protruding ominously from his back with a clear message from Grandma - don't mess with my meds!

Seriously though, it is definitely a headache to restrict usage of a drug once it's on the market, despite its potential dangers, unless you want a patient registry like thalidomide has. The genie wants out of that bottle. So could we trust Merck and Pfizer to carefully restrict the sales of these drugs, to only be prescribed to those who have failed other older therapies, have no additional risk of CV illness, and have a miserable QOL (Quality of Life) without COX-2s? The overutilization is a joint effort between the Pharmas and physicians, who can't be bothered to do any drug research beyond what the reps give them, and who also probably didn't have pharmacology in med school. Still, we believe these drugs should have some place in the armamentarium.

The Washington Post gives us lots of pain today, as they have articles on the Naproxen findings, as well as using accupuncture for arthritis, and physicians getting upset at the DEA for giving them chills. While we certainly want physicians to more aggressively treat pain, with opioids if necessary, we still can't help but laugh at this passage:

"[T]he government can open investigations on the suspicion that a doctor is diverting controlled drugs or to make sure there is no improper activity. In reply, the three pain groups wrote: 'Reading that the government can investigate merely on suspicion that the law is being violated will send chills down the spine of practitioners who are treating patients with [narcotic painkillers] ....'"

"Merely on suspicion"? We don't watch much crime TV, but isn't suspician usually what causes investigations? Investigation does not equal indictment. Does the fact that an investigation may be underway cause problems for a practitioner who is not violating the law? What level of evidence should the DEA require for starting investigations...Rush Limbaugh parking in front of the doctor's house?

Is Celebrex Going Down? and Tauzin Chutzpah!

2004-12-17T10:44:00.000-08:00

It seems that maybe all COX-2 inhibitors may be the same indeed. Pfizer announced that a trial similar to Merck's for preventing adenomas revealed a 2.5 greater chance of having a major fatal or non-fatal cardiovascular event than those on placebo. Pfizer's release is here, and the AP coverage is here. Note that the dosage used is at the higher end of what is prescribed for arthritic pain, so maybe Pfizer can hope this is a dose-dependant effect, and salvage some sales of Celebrex, which are about 6% of Pfizer sales.

Billy Tauzin has scored a major pay increase, by accepting a position as the head of PhRMA (no relation). There are of course the usual disclaimers that this is not a reward for his authorship of the Medicare Drug Bill. My favorite part of this article is the quote from Tauzin - "This industry understands that it's got a problem...It has to earn the trust and confidence of consumers again." Ironically, surveys have suggested that the more a senior citizen is aware of the parameters of the Medicare drug bill, the more likely they are to oppose it. So, Mr Tauzin, why do you imagine the industry has lost the trust and confidence of consumers?

Another dumb person story hot on the heels of yesterday's woman in the Post who isn't happy enough with her daughters: a survey showing that smokers are ignorant about health issues of smoking. The only unfortunate thing is that these folks will generally live long enough to pass on their stupid genes to the next generation. Well, at least they won't be sucking benefits out of Social Security for too long into retirement, since AstraZeneca's Iressa doesn't seem to improve survival over placebo.

A few new links for today....

2004-12-16T20:07:00.000-08:00

Today we're keeping it simple, providing some links to interesting reading. With apologies to James Taranto and the Daily Howler, we are also adopting the first person plural.

First up, we have the NIH admitting to flubbing safety standards in African trials for nevirapine, trying to reduce mother-baby transmission. What is disturbing here from our perspective is that the NIH performs so much of the basic science that brings us new medications - we would hate to see Congressional rats drag this organization over the coals, the way they tried to dismantle the FDA after the Republican takeover. The NIH contribution to drug development is not as well known as it should be, but some recent books are trying.

Next up, an article in the Washington Post (we like to link to them, because they don't yank access to articles after seven days, like SOME publications we could name) about choosing the sex of your baby by genetically examining the embryos before implantation. Nothing about drugs here - we were just appalled at the bitch mom who states "My husband is a 'Junior' and has a family business that he wants to continue in the family name...I'm excited, [w]e always wanted a boy" with the picture showing her surrounded by her three unworthy daughters. This reminded us of articles that appeared a few months ago in various places about "missing" tens of millions of girls in China and India. Unfortunately, they aren't missing because of genetic testing - they are aborted more frequently now due to increased access to ultrasound machines in rural areas. Since the fetus has to be far along to see the sex on ultrasound, we're talking about a LOT of second term or later abortions. It's all about devaluing girls.

Lastly, we cannot resist the urge to make crash-test dummy jokes about the Consumer Union's new website comparing drugs in the same therapeutic class, like NSAIDs and PPIs. Seriously though, this sort of information is invaluable, until non-placebo controlled trials are mandated, as they should be.

We would also like to note that to gin up some publicity, we have posted a couple of book reviews on Amazon, hoping to lure a few innocent pairs of eyeballs to this blog, as well as a "Listmania" list. Let me know if it works.

Drugs as "Unavoidably Unsafe" products

2004-12-13T07:53:00.000-08:00

I have a huge range of topics that I could explore following the previous post, but I decided to first discuss in part the topic of torts, and answer the question posed earlier – why are pharmaceuticals treated differently from all other consumer goods, when it comes to harming user? The phrase to remember is “unavoidably unsafe products.”

Pharmaceuticals have a special "carve-out" from product liability laws, because there is no way for them to exist without someone experiencing harm when taking them - side effects or "adverse events." There would be no drug industry if they were evaluated by the courts the same way a toaster manufacturer would. The link above discusses the different ways that a product can be found to be defective. Manufacturing defects are the first that come to mind, but if there is an alternative design for a product that would make it less hazardous, then there can be a Design defect. If the product is sold with inadequate instructions or warnings, it may have a Warning or Labeling defect, even if the product itself can remain on the market. The question for drugs is in the risk/benefit ratio - is the drug a net health benefit for medicine, to justify its risk? That depends on how severe and frequent the side effects are, and what the drug is used for. We accept far more dangerous side effects like leukopenia from chemotherapy medications than we would from an anti-histamine.

These definitions were codified in a document called the Restatement of Torts (Second) and the sequel, the Restatement of Torts (Third) in 1962 and 1997 respectively. The American Law Institute wrote these documents, to try to create a uniform approach to torts that state courts could adopt, but they have all interpreted the Restatements with shades of difference, keeping lawyers (and law professors) at full employment.

This link will take you to a case that had the manufacturer of Accutane as the defendant. Scroll down a bit to the section titled "IV. Analysis" and there's a nice summary of the Restatements, including Section 402A of the Second Restatement which deals with product liability, and Comment k, which deals with unavoidably unsafe products, including drugs.

If you’re a pharmacist, there's and excellent review of pharmacist liability here, at Medscape. You have to register to see the article, but it's free. If you prefer not to, Google has the article cached a huge document available that gives the latest stats on the utilization of drugs in the US. The .pdf is 14.4 MB, but you can look at individual sections, or an executive summary, if that suits you. We're taking more drugs than ever, more people are taking multiple drugs, yadda yadda. Any surprises here? It's good to know the scale of what we are here to discuss, however, so take a look.

Rep. Pete Stark of California, who gave us the Stark Ethics in Patient Referrals Act (Stark I and II), wrote an article last Friday concerning drug re-importation from Canada, reprinted widely. I have nothing more to add to the article at this time, other than to note the absence of dead Canadian bodies piling up outside of Vancouver pharmacies.

Pharmablogger Welcome

2004-12-09T11:57:00.000-08:00

Welcome to the Pharmablogger page. My mission here is to showcase information relating to the negative practices of the pharmaceutical industry, particularly focusing on the legal issues that arise from fraud, defective products and labeling, and so forth. I will also comment and link to any aspects of health care that tickle my fancy. It's my space, after all.

The passage of the Medicare Prescription Drug Improvement and Modernization Act of 2003, and the related lobbying effort that went into the passage of this ridiculous giveaway bill was the catalyst for my immersion into the literature of Pharma fraud. Much of that material I was already familiar with, but recent publications have pulled a lot of material together well, and I will be recommending titles and articles as I go along.

I've also witnessed truly innovative medicines being developed and brought to market, but frankly, that's such a small part of what the Pharmas do that I almost hesitate to mention it. But I've seen the faces of people whose lives had been improved or even saved by medications, and I can't discount that. I'll talk about that in the future as well, and talk about where those innovative meds really come from.

To get started, I would like to direct you to sources of material on the internet, so you can see what lies behind the nice Lance Armstrong ads and The World brought to you by Merck (NPR). Let's start with something provided by the companies themselves (because they have to!)

My favorite part of any Pharma annual report is the Contingency section in the Financials, where you can find information regarding ongoing and potential litigation. Any Pharma company is going to have a significant (and growing every year) section that details suits against them by class action plaintiffs, shareholders, the Department of Justice, various Attorneys General, or in the case of Merck, all of the above! (and more!) You have to look deep for this stuff, though. For Merck, the litigation liabilities is found in Note 9 of the financial section, not widely read. It starts on page 42 - http://www.merck.com/finance/annualreport/ar2003/pdf/merck2003ar.pdf
If you follow that link, you'll see a reference to lots of different kinds of litigation. However, the headlines all come from civil cases involving personal injury. It's important to understand the unique position that drugs have in the realm of product liability. Think for a moment - if you buy just about any kind of consumer product, use it as intended, and you end up in the hospital or a morgue due to an injury that unmistakably results from the use of that product, you've got a case, and that product won't be around for long, thanks to product recalls, voluntary or otherwise. But this happens to hundreds of people everyday who take prescription or OTC (Over The Counter) drugs. These drugs are not removed from the market, yet for the most part, these hundreds of people every day have no compensation for their injuries. Why? Pharmaceuticals have a type of immunity that just about no other product has. I'll provide further information about this concept later. I'll also have a numbers day, to provide the scale of some issues I'm bringing up.

Here's a few more Annual Reports available online:

AstraZeneca - Page 104, inside the section "Assets pledged, commitments and contingent liabilities"...enough to make any casual reader flop unconscious on his/her keyboard. Note the Zoladex Corporate Integrity Agreement at the bottom of page 106, resulting from when they were very bad. This will be a future topic of discussion, concerning fraud against the government.

Pfizer - Page 49, Note 20 of the financial section. Items to note include the patent action "against the manufacturers of competing PDE5 inhibitors for infringement" of their "broad patent...covering the use of orally-effective PDE5 inhibitors for the treatment of male erectile dysfunction." Say what? Pfizer makes Viagra, which is an "orally-effective PDE5 inhibitor." They have a patent on the Viagra molecule, naturally. But in October 2002, they got a patent not just for that molecule, but for the entire method of treatment of impotency. So Cialis and Levitra manufacturers (surely you've seen the ads!) have their own molecule patents, dating prior to October 2002, but are infringing on Pfizer's patent on an entire disease "target." Incredible. Imagine if the first manufacturer of the fork had received a patent not only on the fork itself, but on the method of using an implement to bring food from the plate to your mouth, and got that second patent after the spoon had also been invented by someone else!

Schering-Plough - Starting on page 62. Take a look particularly at the "Investigations" sections starting on page 64. Under the "Pennsylvania Investigation" and "Massachusetts Investigation" heading, there's information regarding attempts to defraud the government by failing to report information that would impact what Medicaid programs would be charged for their drugs. Also note the US Attorneys who are investigating these issues - Eastern District of Pennsylvania, and Massachusetts (Philadelphia and Boston offices). You'll see these folks again and again, as they are the most aggressive (and successful) litigators against Pharma fraud.
Just pick any company that you can think of, put their names in front of www. and put .com at the end, go to the investor relations section of the site, and look for the Annual Reports. I picked the above companies at random, and was not disappointed!

Get an idea of what a huge product liability suit can cost from this Businessweek article on Merck and Vioxx. The two analysts cited disagree on the costs, but the lower figure is $15 billion (ouch!). But with earnings (EBITDA) of $8.76 billion in 2003, don't look for bankruptcy proceedings anytime.

The Washington Post has a review article on those five drugs cited by David Graham of the FDA as being potential Vioxx - type disasters, and discussed alternative to the meds. All of the companies are rigorously defending their franchises, including this rather extraordinary attempt at public disclosure of safety issues regarding the AstraZeneca drug Crestor.

Again regarding AstraZeneca - new trial results showing that their drug Anastrozole (Arimidex) cuts the risk of breast cancer recurrence over the standard therapy of Tamoxifen. This is good news of course - estimates of lives saved by Tamoxifen (despite life-threatening side effects of blood clots and uterine cancer) are enormous when added up over the years, and Anastrozole does not seem to have the negative estrogenic effects that result in the clots and uterine cancer. Curious how the drug name is not mentioned in this article until Paragraph 9, while the Associated Press article, likely to be printed by most newspapers, mentions the name in Paragraph 2. You would think that these results would be bad for the Tamoxifen manufacturers (generics are available) except for the fact that Tamoxifen is also sold by AstraZeneca.

As I've said before, I'll visit all of the liability issues in future posts, as well as post links to the daily news coverage of Pharma issues. The examples above were meant to whet your appetite. Have I succeeded?