Saturday, June 25, 2005
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.
Monday, June 20, 2005
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.
Friday, June 17, 2005
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?
Thursday, June 16, 2005
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.
Tuesday, June 14, 2005
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?
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.
Thursday, June 09, 2005
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.