Vioxx Verdict: Cargo Cult of Pain and Suffering
Published on 29 Aug 2005 at 12:00 pm |
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Filed under The Cargo Cults of Business, Brain Trust, Winners and Losers, Business and Corporation Related, Health and Safety, Legal, Law, and Courts, Government: Federal, State and Local.
OK, so, Vioxx has pretty much been done to death across the blogosphere. I’m not going to let that stop me from chiming in, because the harm done to the medical industry by that hapless group of jurors is just inconceivable. This is a poster case for the disaster that results when appearance takes the lead in judicial matters. Ted Frank over at Point of Law has a substantive rundown of the blast radius. What continues to distress me about this case is the just totally clueless manner in which the jurors, suddenly faced with a case involving complex technical information, were prepared to just completely tune out the "wah-wah-wah" and start punting purely on the basis of emotional whim. (It should be noted that I am relying here on citations by Dr. Bainbridge from the Wall Street Journal, the folks at the Journal having cleverly hidden the article in their pay-per-view section, thus continuing to ensure that I will never again be among their subscribers).
And this is cargo-cultism at its worst: the substitution of completely disjoint criteria in critical decision making that will affect the lives of thousands, if not millions, of people. As noted in my previous post on vaccination, while I’m among the last to leap to the defense of Big Pharma, in this case I can’t help but be aghast at these proceedings on Merck’s behalf. Certainly, as Warren Meyer notes over at Coyote Blog, this ruling is yet another blow to liberty as it further erodes the ability of legal adults to willfully assume risks. But as Ted Frank incisively notes, the real harm that is happening with this case and others against our medical establishments is that, by curtailing (to the point of asphyxiation) our ability to willingly choose risk, we leave the organizations that we rely on to sustain our health and well-being with a no-win scenario. Either they take ever more conservative positions in product development, or sail merrilly into bankruptcy.
Being corporations, we know which direction the helm will have to be set. And, as one of the patients dependent on Vioxx for interim management of my Repetitive Strain Injury wrist damage, I am personally going to suffer because of 9 morons who couldn’t be bothered to think carefully and diligently about the one salient issue in this case: assumption of risk. Walter Olson at Overlawyered makes the case for this concisely. For us to avail ourselves of effective medical care, we simply must have the ability to decide, for ourselves, whether the benefits outweigh the risks.
This doesn’t excuse Big Pharma, or any other medical institution, from proper and forthright risk disclosure. But in my opinion, the real blame in this whole mess goes to the judiciary, who have been steadily and thoroughly corroding our judicial system into a parody for the better part of a century by not employing robust gatekeeping in the admission of cases. Not only was the evidence in this case weak, but the use of any drugs that substantially alter biological operations in our bodies are going to carry some inherent risk. Even seemingly innocuous drugs can throw patients with substantial allergies into anaphylactic shock. And what implications does this imbroglio have for the food industry; will the FDA outlaw eggs because some people can have life-threatening allergic reactions to them?
If I was the judge in this case, I’d be ashamed to show my face in public for even letting such a specious suit go to trial. Certainly, there’s a strong legacy of judicial malfeasance in allowing the jury selection process to be reduced to a pick-the-best-idiots contest by excluding anyone who might actually have a clue and be able to apply critical thinking to the matters at hand. But the real problem with these cases is that, when there have been clear disclosures of risk (and the drug monographs, if not the patient brochures, are certainly clear), suit is still permitted to be brought.
I don’t know what the answer is for our medical establishment. Even the passage of damage limitation laws and, as the WSJ suggested (via Professor Bainbridge), tightening FDA approval won’t be enough as long as our judiciary is running out of control and letting dubious cases with clear and prevailing indeterminacy in the door. At this point, the predatory damage lawyers can– and will– challenge anything, regardless of how deep of a legislative bunker it is protected with. Big Pharma’s lobby is in a position to do themselves and their consumer constituency a world of good, simply by focussing their efforts on judicial reform.
Because it’s a sure bet that we haven’t seen the last of a jury that can’t– or won’t– think, even to spare the suffering of millions of other human beings.
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September 3rd, 2005 at 11:38 pm
I simply can’t understand why you can say these things while knowing so little. Do you know that Merck used the doctors who testified against them for research? That they spoke highly of them in their own records?
This entire case is about what you want: Willingness to assume risk. If Merck would have said from the beginning, “this drug is little better than an aspirin for most people. Some people see great results. Its main benefit is that it causes less stomach problems than aspirin does. But it also greatly increases risk of a heart attack or a stroke, so if you have lot of cardiovascular problems, you may want to consult further with a doctor. Take in a 12.5 mg dose, or at maximum 25mg” WE WOULDN’T BE HERE TODAY. They would have said WHAT THEY KNEW, and everyone would have known and could have chosen accordingly. Many would have chosen to take it.
But they didn’t. They hid documents. They recategorized patients as “unknown” in studies who had actually died of heart attacks. They lied to doctors and intimidated researchers at places like Stanford. They threatened people, all so they could market a niche drug as some sort of cure-all.
Have you read the letters the FDA sent to Merck in 2001, lambasting them for the claims they were making about their drugs? One study clearly showed a 5x greater risk of cardiovascular problems over naproxen, but Merck’s press release was titled something like “Studies confirm cardiovascular benefits of Vioxx.” What is okay about that?
All you as a drug manufacturer have to do is tell me. Tell me the truth. If you don’t know when it comes out, tell me when you do. But don’t lie and hide to make more money.
Why should a judge have thrown out this “specious” case when the leading cardiologists have been trying to get the drug removed for five years? Why when there are emails reported on in the Wall Street Journal indicating that Merck’s top executives knew years and years ago that the cardiovascular risks were there? And why when the 1991 Merck Manual contained a section on the cardiovascular risks of altering the prostacyclin/thromboxane balance (this was 1980s science), but REMOVED IT in the next edition, as they began work on Vioxx?
Every single fact was presented to this jury. If you don’t like people who are probably poorer than you, just say so. If you want to rant without knowing the facts, just give us that warning before we assume the risk of reading this stuff. But don’t blame the jury for making the ONLY decision that could have been made.
September 4th, 2005 at 11:21 pm
Dale,
I think you have missed the thrust of my commentary. I have no dispute with the facts you bring to bear. It is clear that Merck engaged in shady and underhanded practices; but this is hardly unusual behavior for Big Pharma.
The problem is that, at least as far as I can tell, nothing that they did was actually illegal. Also, as best as I can tell, they even had made note of potential cardiovascular effects in their original monograph (the link is to an early Canadian version; I wasn’t able to locate an initial U.S. copy).
In 2002, they revised their Canadian monograph in response to the Canadian health authorities. But in the U.S., they did nothing. Why? Because, as you indicate, the FDA used lots of harsh language but no legal force.
It is this lack of any actual illegal activity that makes the lawsuit specious, and grounds for dismissal. The indication, however insufficient in light of later facts, in the earlier monograph of potential cardiovascular problems also stands sufficiently as a disclosure to throw reasonable doubt on the plaintiff’s case. Now, you can argue that Merck’s behavior is so unconscionable that they should be tried anyway for their dirty deeds, regardless of their legal compliance, regardless of pre-existing disclosure. I wouldn’t agree, but it’s a valid argument all the same.
But that’s the whole problem, and the entire point of my original post: They weren’t tried for any of their actual underhanded behavior. You mention that every single fact was presented to this jury. Well, based on every account that I’ve seen, the jury didn’t pay one whit of attention to those facts. They preferred to make their decisions based on irrelvant, emotional, and self-aggrandizing criteria (like getting on Oprah). This is a travesty; it is cargo cult justice.
And that was the focus (or, at least, intended focus) of my initial post. I didn’t address Merck’s villainy simply because it’s off-topic for our site; we focus on appearance-over-reality, not unconscionable corporate behavior per se (we could never remotely hope to cover all that effectively). I did try to note it in passing (”This doesn’t excuse Big Pharma, or any other medical institution, from proper and forthright risk disclosure.”), but apparently not explictly enough.
As I am oft want to say, “the only conscience of a corporation is the limits set by law”. Should the FDA have forced Merck to revise the monograph, and conduct further CV studies? Absolutely. Should Merck have acted in the cause of virtue and proactively updated the U.S. monograph as well? Absolutely, as far as ethical behavior is concerned.
But unless it’s illegal to not do those things, it is wrong- and unethical for the judiciary- to try a corporation when they are complying with prevailing law. I’m the first to argue for judicial and legislative reform in eliminating (not merely reducing) the ability of corporations to subvert government processes. But a principled stand requires that I also recognize the real deficiencies in this situation, and here that lies with the FDA (and, further up, Congress) for letting Merck get away without revising the Vioxx monograph, and the judiciary for allowing suit to be brought against a legally compliant firm.
My previous post on the vaccination debacle shows what I think of collusion between Big Pharma and Government. But the Vioxx trial and subsequent verdict were a drumhead, a kangaroo court at its best. Invective and polemic, not justice and reason, carried the day. Had the FDA stepped in when they should have, the U.S. monograph would have been revised, the plaintiff would have had no case, and Vioxx would still be on the market. As it was, the lack of action by Congress and the FDA, and the fact they did indicate a potential cardiovascular risk, left Merck legally in the clear, however black their ethical position.
And, in point of fact, I think Vioxx should still be made available, just with the updated monograph and attendant risk disclosures. Instead, because a jury (and, by extension, the larger populace) are willing to act on emotion and not on reason, I and millions of others, who did not and would not experience any untoward effects of the drug, are now unable to obtain it, regardless of our willingness to assume risk. And barring some miraculous intervention on the part of the FDA, I don’t think that likely to change.
Regardless of any differences in our views, many thanks for your insightful and very relevant contribution to the discussion. You illuminate key issues that need to be, indeed must be, addressed within our medical industry. And I think getting them sorted out, and sorted out in favor of the patients, is all the more important in the wake of the Vioxx case.
Paul