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Tilting at Windmills

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November 17, 2007
By: Kevin Drum

VIOXX....Shorter Joseph Nocera: Mistakes were made and lots of people died. But that's certainly no reason to take the extreme step of getting the legal system involved. Brad DeLong has the longer version.

Kevin Drum 2:44 PM Permalink | Trackbacks | Comments (30)

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It's not that the legal system shouldn't get involved. It's that the way it got involved is dysfunctional.

First, lawyers end up with billions of dollars. It would be better to give those billions of dollars to the FDA so they can use it to monitor drug safety and development more closely. That is money much better spent than all the money it takes for lawyers to spend hours interviewing every drug rep who ever sold a drug, go through millions of pages of company documents, and then litigate thousands of trials.

Second, most of the true victims are grossly under-compensated. For many, the settlement will not even cover the medical bills caused by the drug. Rather than spending our money on trials, spend it on national healthcare. People should get treatment without having to play the litigation lottery.

Third, in any of these mass torts, there are countless people who get money even though the drug likely never caused them any injury. This is because it is incredibly difficult most of the time to determine whether a drug caused an injury in a particular person, even if it is certain that the drug causes injury among some portion of the population that took it. The true victims of the bad drug have to share with people who were not harmed at all.

There has to be a better way.

Posted by: Awesome-O on November 17, 2007 at 3:34 PM | PERMALINK

Awesome-O: (1) If the lawyers don't get paid, no one will ever bring a case and corporations will be free to act negligently without penalty. (2) Everyone here is in favor of national healthcare, but we don't have it right now. Besides, case like these usually involve non-medical costs too. (3) There is no way in a case like this to determine harm with 100% accuracy. The courts do the best they can given the current state of the art in human diagnostic capability.

There might very well be a better way. That's what everyone says. But what is it? What's your preferred system for adequately motivating corporations to act safely and adequately compensating people who are harmed by corporate negligence?

Posted by: Kevin Drum on November 17, 2007 at 3:59 PM | PERMALINK

As somebody who would like to see the comprehensive socialization of product liability risk, the thing that upset me the most was that he criticizes the current system without offering any alternative other than giving corporations a free pass...

Nocera used to be smart. What has happened?

Posted by: Brad DeLong on November 17, 2007 at 4:12 PM | PERMALINK

"What's your preferred system for adequately motivating corporations to act safely and adequately compensating people who are harmed by corporate negligence?"

Public stocks -- like the ones at colonial Williamsburg. And LOTS of garbage.

In August.

With television.

Time tied to executive compensation.

Posted by: theAmericanist on November 17, 2007 at 4:18 PM | PERMALINK

As a plaintiff's lawyer, let me add to this debate: to take a single Vioxx case to trial, even with the prepackaged materials from the earlier attorneys, requires bare minimum 100 hours of a lawyers' time, excluding the 50+ hours by secretaries and paralegals.

To that time, add bare minimum $50,000 in expert fees and $10,000 in litigation costs.

Vioxx defense attorneys bill anywhere from $250-$450 an hour.

So these greedy trial lawyers have to put in at least $25,000 worth of their time and at least $60,000 of their money just to get to trial.

Now consider: so far, *not one* plaintiff has collected from Merck. All trial verdicts have been appealed.

Plaintiff's lawyers take an enormous risk, particularly in mass torts, including the risk that even a slamdunk case (like Mark Lanier's) will go years without recovery. Their fees have to reflect that or their business can't survive.

And look on the other side of the coin: Merck could have settled with all of these victims on their own. They didn't. It took years of bruising litigation to get them to even consider it.

Cut out the plaintiffs lawyers, and no one will ever get a dime.

Posted by: M on November 17, 2007 at 4:28 PM | PERMALINK

Yeah, and you can bet that if any one of these high-minded, tut-tutting "tort reformers" ever suffered an injury to THEMSELVES, or to a member of their families, they'd be running to the courthouse as fast as their pudgy little legs would carry them.

Everybody hates lawyers -- until they need one.

Posted by: bleh on November 17, 2007 at 5:31 PM | PERMALINK

What's your preferred system for adequately motivating corporations to act safely and adequately compensating people who are harmed by corporate negligence?
-------------
The biggest problem IMO is the massive profits being generated by the drugs in the first place. If the prices were capped by the government and big pharma wasn't allowed to charge what the market would bear for a new drug, they would think twice about introducing something that risky. The profits are so huge, they are factoring in the cost of the potential lawsuits down the road before the first tablets hit the pharmacy. It pays for them to poison us.

Posted by: Doc at the Radar Station on November 17, 2007 at 5:53 PM | PERMALINK

Direct-to-consumer drug advertising is the most pernicious problem, in my opinion.

The matter of the foxes-guarding-the-henhouse with regard to drug companies being responsible for deciding whether a drug is safe for consumption (E.g., the pharma does all the research on their med --including possibly fudging some result-- and giving the FDA the info used to decide whether to approve sale of a drug)... that is a problem I can't find a better solution to. Maybe any pharma with a new med it wants to market can pay some govt agency $x million dollars which is then passed along to random university which will perform the drug trials -- so that the only input by the pharma is the demand that this med gets drug-trialed and the money given to perform the trials.

Posted by: absent observer on November 17, 2007 at 6:30 PM | PERMALINK

Absent observer -- the Vioxx case certainly shows that the system is imperfect (although even in this case, it ultimately caught up), but the notions of "foxes guarding the henhouse" and pharmacos "possibly fudging some result" are just wrong. The US drug approval and regulatory system is extremely stringent. The standards candidate drugs must meet are qualitatively tighter even than they were when Vioxx was approved, and those in turn simply are incomparable to the standards of a generation ago. (Tylenol, for example, is widely considered unapprovable under current standards.) Doctors, development professionals, and regulatory officers at pharmacos are extraordinarily diligent -- and keep in mind that medical doctors, who are almost uniformly extremely ethical and concerned principally with patient health, are involved at every step of the development process.

I think you're much closer to the mark when you criticize DTC marketing (which blossomed in the Reagan years as part of the Republicans' business-friendly ideology, BTW). To the extent uninformed consumers, rather than medical professionals, initiate the use of pharmaceuticals, there will always be the problem of misleading claims and overuse. Not, of course, that there's anything wrong with informed consumers, or with patients requiring that they understand what medications are being prescribed for them and why -- quite the contrary -- but, as the Vioxx case shows, pharmaceuticals are not an easy matter to understand, and the risks of mistakes are high.

By the same token, the development of pharmaceuticals is complicated, and it's not well served by loose rhetoric. Pharmaceuticals have literally brought about a revolution in medicine -- compare the situation today with that of a generation ago, much less two! -- and when we tinker with it politically (as the Reagan deregulation shows, for example), we're literally playing with peoples' lives.

Posted by: bleh on November 17, 2007 at 7:53 PM | PERMALINK

Merck is a highly visible, widely held stock. Vioxx's problems, or rather the announcement of the problems took about $40 billion off the market value and it's only after 3 years (and the announcement of a settlement) that the stock is back trading near where it was before Sept. 04. It pays for them to poison us. I don't think a smaller company would have survived the Vioxx situation, or perhaps it would have been like the asbestos claims. Is that worth "poisoning us"? It's not really about the money, but that certainly is a visible benchmark.

What to do? Now (PBS) had 2 suggestions, one which was in Dr. Graham's testimony to Congress in Nov. 04: ...solved by removing post-approval monitoring duties from the FDA and giving them to a new independent agency. Critics of this plan say that this would only add another layer of bureaucracy and additional costs to the process.

The other: Another solution may be to follow the example of the European Union. There the European Agency for the Evaluation of Medicinal Products (EMEA) reauthorizes (or not) drugs after five years on the market.

The Now page is here.

Posted by: TJM on November 17, 2007 at 8:32 PM | PERMALINK

The EMEA 5-year re-authorization is a recent innovation, and discussions have been underway for quite some time in the US about doing the same sort of thing.

So-called pharmacovigilance, i.e., systematic post-approval monitoring of adverse events (and efficacy) is another area where, IMHO, our regulatory system needs improvement.

That said, it's expensive. If it's going to happen, and happen reliably and independently, it needs to be properly funded. And there's no reason for it to occur outside the FDA. The FDA has all the necessary resources, as well as the institutional memory and records, to conduct it perfectly adequately. As long as there's no "capture" of the monitoring arm by the approval arm (as there has not, for example, been in many other regulatory agencies), then there's probably many reasons it would be more efficient to locate it within the FDA.

Posted by: bleh on November 17, 2007 at 8:57 PM | PERMALINK

I don't think a smaller company would have survived the Vioxx situation...
Posted by: TJM on November 17, 2007 at 8:32 PM
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My points exactly. If the profits would have been limited, they wouldn't have taken the risk to bring it to market in the first place and there wouldn't be any "situation" to be considering. The profits are the problem.

Posted by: Doc at the Radar Station on November 17, 2007 at 9:33 PM | PERMALINK

Sorry to repeat, but the evidence is that Merck knew that there were serious risks associated with taking their product -- several studies showed that conclusively. Rheumatologists already knew this in the early stages. That does not necessarily mean that the drug should never be used (even Thalidomide has important therapeutic benefits, as is now becoming recognized), but that the doctors who prescribe it and the patients who take it have to be told. Most rational people would go to the competitor were they told of the risk, which is of course why Merck covered it up.

How about holding Merck executives criminally liable for the coverup? I am not aware of anything in the Constitution that would forbid this. In addition, how about punishing Merck (in the civil litigation process) for its failure to bargain in good faith with the victims of its criminality? One way would be to allow juries to add to the verdict based on how seriously the offending company stonewalls its victims.

Posted by: Bob G on November 17, 2007 at 9:45 PM | PERMALINK

This is a subj. I know nothing about, but I remember somebody telling me about a case some years back, when an HMO (I think) had tested some guy's blood for more stuff than they were required to, including an HIV test. The guy turned out to be HIV+, but THEY DIDN'T TELL HIM, cuz that would have meant... God knows what.

And I thought: there is something wrong with a system where people acting in a fiduciary capacity on the part of their employer and the stockholders can't simply do the right thing -- AND cannot be held accountable for that failure. I wonder if it isn't simply that all the incentives are negative. You CAN'T tell the guy he's HIV+, cuz that would hurt your employer. You CAN'T change that policy, cuz that would hurt the stockholders.

Isn't there some way Bob G.'s insight could be made positively? Merck (and anybody else) naturally felt an obligation not to help their competitors, but....

Posted by: theAmericanist on November 17, 2007 at 9:55 PM | PERMALINK

Doctors, development professionals, and regulatory officers at pharmacos are extraordinarily diligent -- and keep in mind that medical doctors, who are almost uniformly extremely ethical and concerned principally with patient health, are involved at every step of the development process.

This may be the case, but isn't it true that meta-analyses have shown significant biases toward finding that specific drugs are effective when the studies are paid for by drug companies making those drugs? I don't see a simple solution to Kevin's more general question about how to provide better incentives for corporations not to screw up, though. Not without making them far more cautious than the public would accept, I think.

Posted by: RSA on November 17, 2007 at 10:35 PM | PERMALINK

the evidence is that Merck knew that there were serious risks associated with taking their product -- several studies showed that conclusively.

Two questions about the "several studies". The FDA testified to Congress that unlike most of the medicines tested, the Vioxx initial efficacy test wasn't run with a control group receiving a placebo. It would seem, wouldn't it, to make it more difficult to isolate the effects of Vioxx vs, other elements? Second, from Dr. Graham's testimony as well as the articles, these are relatively long term studies; it was several years, wasn't it until it was clear that Vioxx was causing the problem?

I knew a couple of people with sever rheumatoid arthritis who kept taking it after the announcement because it worked very well for them (and, of course hadn't killed them...yet). It was very effective.

Indirectly, you know, this is all PETA's fault. If you can't test these things on bunnies, we all end us as guinea pigs!


Posted by: TJM on November 17, 2007 at 10:43 PM | PERMALINK

My Vioxx complaint is that I can't have it any longer. I am mid 40's, healthy, fit, low lipids, low BP, perfect chemistries...when a horse is healthy, they say it is as healthy as me.

However...I played soccer for 35 years and spent 20 years on trauma teams, jumping out of helicopters and running at full speed between blood banks and trauma bays, and my knees are shot to hell and I have scars from nine surgeries to prove it. I have rebuilt patellar tendons, rebuilt ACL's, one rebuilt MCL, degenerative joint disease, and osteo-arthritis, and the five years I took Vioxx were the most pain-free and highest functioning years of my life since I had that first compound fracture sliding in to second when I was 15. (I was safe.)

I would sign any waiver and pay any price if I could just have back the drug that worked for me and gave me the most relief.

Posted by: Blue Girl, Red State (aka G.C.) on November 17, 2007 at 11:07 PM | PERMALINK


You might be in the small fraction of people who would get a net benefit - but you might want to look a bit harder. For example, do you have factor V Leiden? Check first.
More than doubling the risk of heart attacks was a bad deal for most of the people taking that drug, a very bad deal. There is no point in pretending that the average person is up to evaluating this kind of risk - that's for libertarians and other fantasists. Not even the average physician is, although that is partly due to the fact that few of them read the medical journals, let alone read them with a critical, statistically educated eye.

Posted by: gcochran on November 17, 2007 at 11:25 PM | PERMALINK

No, I don't have V Leiden, and I do know what it is (I'm a lab scientist and specialist in blood banking). (V Leiden is a genetic trait that can cause thrombophilia, or hypercoagulation.)

I am one of the people who enjoyed a net benefit, and one of the few with the professional background to read, understand and synthesize the information in professional journals.

Posted by: Blue Girl, Red State (aka G.C.) on November 18, 2007 at 12:00 AM | PERMALINK

RSA: I'm sure it's true -- although I haven't seen any analyses -- that pharmaco-sponsored studies are more likely to show efficacy than non-pharmaco-sponsored ones. Study results are highly sensitive to design -- there's a small industry devoted to this precise topic, in fact -- and it follows naturally that pharmacos choose designs most likely to show the best results. That's not to say that the results are scientifically invalid -- they're perfectly, peer-reviewably, regulatory-acceptably, valid scientific results. It's simply that they are chosen to present the potential product in the best possible light. (It would arguably be a breach of fiduciary duty for them to do otherwise.)

What it DOES mean, though, is that the regulatory regime needs to be appropriately skeptical. (The same of course is true of the consuming professionals and public, if they're capable, although unfortunately few are). This is a classic case of the failure of Libertarian dogma; this stuff is technically deep and complex, and for the most part it's inpractical for physicians, let alone patients, to be able to parse the claims and weigh the evidence.

Oh, and TJM, sometimes it's impossible to conduct a study that fully assesses efficacy, because of ethical concerns. Clinical trials that assess efficacy are typically performed with patients, and there is an overriding ethical mandate that the treatment of patients' conditions supersedes the scientific goals of a study. If treatment with a placebo would essentially be subjecting those patients to a hoax, or not treating a condition for which they need treatment, you just can't do it, even if that blunts the scientific conclusions of the study. I have no idea whether that was the case with any Vioxx studies, but FWIW...

One other observation. Pretty much all medical treatment is subject to individual judgment and to substantial uncertainty, and pharmaceutical therapies are no different. It's not realistic to expect certainty in ANY medical treatment, only to demand that risks be understood and communicated, and that judgments be made in the best interest of the patient. We naturally must insist on full honesty and ethical behavior from pharmacos (and from physicians), but at the same time we need to be careful not to throw the baby out with the bathwater.

Posted by: bleh on November 18, 2007 at 1:08 AM | PERMALINK

Well the problem is that the tort reformers want to replace mercenary justice with no justice. Which is obviously a really bad idea.

The solution would be to give government and law enforcement real teeth when it comes to dealing with public corporations. I'd say the combined profits of the last 10 years would be an appropriate fine to pay, wouldn't it? Then that money could be used to fund the system, and as well to try and make whole..at least somewhat..the victims of this mass murder.

Posted by: Karmakin on November 18, 2007 at 7:19 AM | PERMALINK

Look, conservatives argued, fifteen or twenty years ago, that there should be no "prior restraint" on business activity--i.e., we should get rid of regulations on industry, and if companies did not police themselves and people got hurt, well then there was the tort system to provide redress. The tort system was *held up* by conservatives as the proper venue for deciding and redressing wrongs.

Now that they have succeeded in gutting administrative law, however, they're whining about "frivolous lawsuits" and demanding "tort reform."

Not.

Posted by: Nancy Irving on November 18, 2007 at 8:55 AM | PERMALINK

Nice summary of some interesting complexities, bleh.

Posted by: RSA on November 18, 2007 at 9:27 AM | PERMALINK

bleh, that's a nice summary although you didn't read my comment closely. The FDA testimony was that Vioxx's clinical trial was not done with a control group precisely because of the ethical concerns. A group receiving a placebo would have been left to suffer. The question was really more along the lines of how can regulators be expected to know more than the company?

The other issue here is that the whistleblower laws aren't really effective, are they? How else to explain the actions of the people who work for Merck who were involved in the post-approval clinical assessments. How could a number of doctors, seeing the results, keep quiet both inside and outside the company?

This debate over which penalty is severe enough, from physical humiliation to death by hanging or mere monetary penalties imposed on the corporate entity, leaves the question of human, corporate human that is, behavior unanswered.

What makes people who work for an organization, like Merck in this case, do things they wouldn't do ordinarily? Let's say a doctor working for Merck knew, or suspected, that people driving inordinately fast through their neighborhood would eventually kill someone they knew, would that doctor somehow find a way to stop those cars? If the probability of death was greater than zero, why would they stand by and simply wait for the occurrence?

I suppose that's why every new safety regulation is written in blood. Whether it's the FAA or the FDA, the result is the same. Until enough people die, there's no change needed. Hannah Arendt was right about more than "good" Germans, Merck's behavior here was the epitome of the banality of evil. The knowledge that those doctors killed people through negligence, fear or greed will confront them forever.

Posted by: TJM on November 18, 2007 at 10:07 AM | PERMALINK

Isn't the answer to Blue Girl's specific situation the answer to all of it: transparency?

Posted by: theAmericanist on November 18, 2007 at 11:46 AM | PERMALINK

It's been my understanding that Vioxx, as a Cox-2 inhibitor, is not really more effective as an anti-inflammatory drug than classic agents like aspirin or ibuprofen, which are more promiscuous and target a second Cox in addition to Cox-2. The advantage of Vioxx is that, because it only targets Cox-2, its use poses less risk of stomach ulcers and bleeding that can result from long-term aspirin/ibuprofen use (blocking the Cox (not Cox-2) molecule can lead to these disorders).

I'd be curious, especially from Blue Girl, to learn if people who have had success with Vioxx or Celebrex failed to get relief from other anti-inflammatory agents? And if so, why do you think Vioxx was more effective as a treatment if, biochemically, its activity should be similar to the classical aspirin/ibuprofen remedy?

Posted by: Chuck Darwin on November 18, 2007 at 12:12 PM | PERMALINK

Chuck Darwin,

Studies have shown the efficacies of Vioxx were comparable to that of NSAIDS like ibuprofen and naproxen.

However, I know numerous people like RedStateBlueGirl who swear by Vioxx's pain relief. This is probably not surprising, though, since different people have different responses biochemically. It is probably the case that you just don't hear from the people who benefit more from ibuprofen, but they almost certainly exist.

Posted by: Yancey Ward on November 18, 2007 at 2:16 PM | PERMALINK

Voltaren is a terrific anti-inflammatory, but some people develop allergies to aspirin and everything chemically related like Voltaren. This is a problem for people who stay on nsaid's chronically. The ability of the aspirin class and other nsaid's to inhibit cox-1 as well as cox-2 results in a reduction in the body's ability to protect the stomach lining. The idea behind cox-2 specific inhibitors was that you could take high doses (enough to get the effects you want) without damaging the stomach concomitantly.

PS: As BGRS knows, the biochemistry is actually pretty interesting: The cells take a molecule that would otherwise be burned as fat or used in the construction of the cell membrane, and using the cox enzyme, turn it into a signalling molecule of the class known as prostaglandins. Prostaglandin E2 provokes inflammation and local pain, and the ability of the drugs to reduce its synthesis is the reason that aspirin, voltaren, and vioxx work as they do.

Posted by: Bob G on November 18, 2007 at 4:24 PM | PERMALINK

Many long-term users that did not get a prescription filled close enough to the heart attack will get nothing while some very short terms users will get much - this is foolish - Merck is the clear winner.

Posted by: Virginia on November 27, 2007 at 6:09 PM | PERMALINK

Virginia, I agree - as a over 2 year user the settlement MUST be amended to take us into consideration.

Posted by: Jerome on November 27, 2007 at 6:11 PM | PERMALINK




 

 

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