Thursday, March 20, 2008

Wax on, wax off

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.

Tuesday, March 18, 2008

Compare & Contrast

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?

Monday, March 17, 2008

Back to the Eighties weekend....

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."

Tuesday, March 11, 2008

Day One

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.

Monday, March 10, 2008

Free pharmaceuticals for everyone!

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."

Tuesday, March 04, 2008

Legal fun!

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!

Sunday, March 02, 2008

Campaign fun!

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.

Saturday, March 01, 2008

John Roberts - Due Diligence foe?

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.