Preemption: The Business Case Of The Century
81 CommentsBy Ed Silverman // October 31st, 2008 // 4:34 pm
This is how CNBC is describing the case to be heard this Monday by the US Supreme Court, which will review the story of how Diana Levine lost her right arm in a clinic after being administered a Wyeth drug. She sued for inadequate labeling and won; Wyeth is appealing.
At issue is the notion that FDA approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Drugmakers and the FDA argue that preemption exists by maintaining the agency’s actions are the final word on safety and effectiveness. The court’s decision, therefore, will be closely watched because its ruling will determine whether patients can sue a drugmaker through state law when a product has already been approved by the FDA.
“When Wyeth took away my arm, they took away my livelihood,” says Levine, a Vermont musician, tells CNBC. You can watch the CNBC clip here. Here is some background reading - various briefs filed in support of Levine; a brief filed by the US Solicitor General; our interview with Levine, and Wyeth’s brief with the court,
Justice in Mi
Just for the record, “the business case of the center” was originally the US Chamber of Commerce’s description of Levine.
And yet, preemptors are trying to suggest it’s all the result of some sort of “hysteria.”
The Chamber is hysterically spending a lot of moolah.
WY
How can Wyeth look at itself in the mirror? Incredible!
Nathan
Levine writes: “When Wyeth took away my arm, they took away my livelihood.”
That’s a little strange that she appears to put all the blame on Wyeth. The drug clearly had a warning against IV administration. The warning was obviously not directed at her — it was directed to the nurse/doctor administering the drug. It seems to me that 90% of the blame here goes to the doctor. She’s just going after Wyeth because they have deeper pockets.
Nathan
If people weren’t so “lawsuit happy”, then maybe preemption wouldn’t be an issue. Justice continually argues that this case isn’t a good one (a “typical” one) for debating the virtues of preemption. But the fact that this case made it this far clearly shows that the “preemptors” have to deal with many “frivolous” lawsuits like this one…
Lisa Van S
Nathan,
Not every Lawsuit is frivolous.
Jaynesday
Nathan, perhaps if the industry wasn’t so “drunk on profit” and bent on the blockbuster drug, preemption wouldn’t be an issue.
Please watch this video about frivolous lawsuits.
http://www.youtube.com/watch?v=h85j1vNxd8A
Nathan
Jaynesday,
Your video about spends much time deriding major companies for funding ads that publicize frivolous lawsuits. This is quite ironic since the very video I’m watching was paid for by “InjuryBoard.com” which appears to be an association of trial lawyers that make their living by suing big corporations!
That said, I do agree with your first sentence. Industry itself is partly to blame for all the lawsuits. But this (Levine) case does not appear to be one of those cases. While industry certainly deserves some of the lawsuits it has recieved. Wyeth has/will pay out ~$22 billion for Fen-Phen litigation. Can you tell me how many people were seriously injured? Current estimates are 1000-2000. Is something out-of-whack? That ammounts to about $100 MILLION PER INJURY!
That is the reason that pharma is pushing for preemption. We cannot survive as an industry with $20 billion liabilities hanging over our heads…
Jaynesday
Nathan, I understand your concern about the source of the video but I found the facts that were presented to be counter to the current commonly held beliefs about “frivolous lawsuits”.
*Medical errors kill 195,000 people per year.
*1 in 8 injured by medical malpractice ever sue
*Medical malpractice lawsuits are decreasing
*Median payouts for all torts is down 55% = $28,000
In my humble opinion the true source of the preemption argument or excuse if you will, originated in the concept of the “frivolous lawsuit” which begat “torte reform”. What is frivolous? It’s pretty easy to label most any lawsuit as frivolous; as a matter of fact that’s what many defense lawyers get paid for. I’m sure they would tell you that they all are frivolous.
It often boils down to a feeling or a point of view and can be just as much based on emotion as the term “undue hardship”.
How many “frivolous lawsuits” are committed each year? Who knows? Until you know what one is you can’t count it. So we just assume that there are way too many and they cost way too much. After all didn’t that lady that dropped the coffee in her lap get $1,000,000 dollars?
Jaynesday
The facts are she only asked for $20,000 after receiving 3rd degree burns requiring skin grafts and 2 weeks in the hospital caused by coffee that was 180 degrees in temperature.
Jim
The fact is preemption has never been part of the original law or of any of any of its subsequent ammendments and therefore their is no legitimate basis for the preemption argument. A basic premise of Contract law is that which is not included is specifically excluded. Now while I understand that this is not a contract law interpretation the basic premise should still be recognized.
On the Medical devices front Congress and the Ford administration felt it was necessary to include preemption for the protection of the device makers in the wake of the Dalkon Shield fiasco.
The current attempt by the FDA and in particular the Bush Administration is attempting to bypass the legislative process and grant the Pharmaceutical industry a protection that was never intended.
While I am not fully versed in the Fen-Phen case, it would appear from what I read that this would have been the case to make the preemption argument, but is was never raised or if was raised it was quickly dismissed. Nathan states that estimates are there are 1000 to 2000 individuals seriously harmed by Fen-Phen, with a preemption policy in place these individuals would have been left in the cold.
The fact is the pharmaceutical industry has brought a lot of this upon themselves. They continually make minor upgrades to existing drugs that do not materially enhance the existing drug’s value yet they are able to gain continued patent protection for these minor mostly useless upgrades. With the pipeline of new drugs shrinking the big winners will be the generic drug makers and we know the Pharma representatives will see huge declines in their earnings. If the pahrmaceutical industry was more upfront about test results for their new products the failure to certify a preemption policy would probably have a minimal effect on lawsuits in general annd corporate profits ovrall.
The Pharmaceutical Industry has engaged in unethical prctices by pushing their products at the ground level in the medical field through the practice of honorariums and kickbacks.
This argument about over warning is ridiculous, I call it informed consent. we as a country probably have more over priced patent protected drugs prescribed where a generic or Over the Counter drug works at least as well.
Is the Wyeth case the perfect vehicle for this? The answer is no. However, why did the Supreme Court grant Certiori for this case, I think the answer is self evident, it’s a case that poorly represents the argument against preemption and probably should have been dismissed at the Appeals court level and even if the Court, as predicted rules, in favor of Wyeth the decision should be narrowly construed.
A federal agency should not be granted the authority that the legislative body did not empower them to have. At least in Riegel v Medtronic, Medtronic had the force of law behind their argument, that law is non-existent in the Wyeth case and exists only in the minds of the Bush Pro-Business mentality. I know the argument for preemption will cite this silence as evidence that their position is correct, however I don’t know how they will defeat the argument that Right To Private Action has been the prevailing attitude since the inception of the FDCA and has not been challenged until recently. If precedence has any value this case should be dismissed or as stated above be narrowly defined.
In closing the Pharmaceutical industry are their own worst enemies, they do not enjoy a high standing in overall public opinion and if they win this case their standing will fall even further. Recalls of newer drugs have gone a long way to diminish this confidence and fiasco’s like Fen-Phen certainly do not help their cause. Consumers will demand generics that have had a long history and where the side effects are pretty well known, so the the Pharmaceutical Industry will fail to realize the great profits they envision for their new drugs.
In closing I would like to add that this is an excellent site and for the most part the discourse among competing ideas is civil. I realize that a number of posters here are directly tied to the industry but this site gives a voice to even those who are not.
Jim
I wanted to add one other thought; if Preemption becomes the law of the land and consumers/patients discover that they do not have any legal recourse at the State level against the Pharmaceutical industry they will set their sights lower, their medical provider. I believe that most doctors do not have the time to pour through all of the details involved with the clinical trials of new drugs and this failure on their part will leave them open to malpractice lawsuits. The increase in malpractice lawsuits will lead to higher malpractice insurance premiums and ultimately a reluctance on the part of physicians to prescribe any new medications.
Nathan
Jim writes: “if Preemption becomes the law of the land and consumers/patients discover that they do not have any legal recourse at the State level against the Pharmaceutical industry they will set their sights lower, their medical provider”
That’s exactly the point — in this case (Levine), the liability SHOULD be with the providor. She is just going after Wyeth b/c they have deeper pockets…
Dianne
Thanks for the powerful video Jaynesday. Its beauty is it is the truth.
“Tort reform isn’t about fixing a “broken” justice system; it’s about protecting the public image and bottom lines of the biggest and most powerful companies in the world. Tort reform isn’t about protecting doctors from high insurance rates; it’s about protecting their insurers from having to pay large judgments. Tort reform isn’t about keeping “greedy lawyers” from filing frivolous lawsuits; it’s about keeping those who are severely injured out of the court system and away from the public eye.” See: http://news.lawreader.com/?p=339
Also noteworthy, Public Citizen reported:
“U.S. Businesses File Four Times More Lawsuits Than Private Citizens And Are Sanctioned Much More Often for Frivolous Suits.” See: http://www.citizen.org/pressroom/release.cfm?ID=1799
So, what happened is the American public got bamboozled about tort reform and Big Business saved Big on lawsuits. Cool. Just ask any greedy pharma lawyer.
Nathan
Diane writes: “Tort reform isn’t about protecting doctors from high insurance rates; it’s about protecting their insurers from having to pay large judgments.”
It must be nice to be a doctor and be able to rely on liability insurance. There is no such thing in pharma. We pay the liability lawsuits out of our own pockets. (Actually, it’s out of YOUR pockets. We have to keep increasing the prices of drugs to cover for all those liability claims!)
Condor
I had resolved to remain silent on these back and forhts — but Nathan’s last mis-statement cannot be allowed to stand.
While it is true that the applicable state law PREVENTS plaintiffs from letting the JURY know about the corporate DEFENDANTS’ insurance policies (to prevent runaway verdicts) — it is simply NOT TRUE that pharmaceutical companies do not carry products liability insurance.
The market is very narrow, and not particularly deep, and yes, riddled with re-insurers, excess coverage “carriers” and various other profiteers — and so, many corporations have chosen to create “captive” insurance companies — really a risk retention pool — funded by the companies themselves. A self funded reserve for liability claims.
So, yes, Nathan, your dear pharma co.s do have already reserved funds to tap — usually the vast majority of such payouts DO NOT come out of “quarterly EPS” figures — this is just one of the natural “prices” of being granted monopoly power. Geez Nathan, try to sound at least plausible — in your goofy attacks, here.
In fact, this (self-funded pooling) is how the insurance giant called ACE got its start, in the early 1990s.
Yes — the coverage is expensive, and waning, but it does exist.
So, I’d encourage everyone to take whatever Nathan writes with a “truckload of salt” — from here on out.
He is a water-carrier. Plain and simple.
NB: It strikes me that Nathan’s FIRST comment in the thread would be comical — if it were not so tragic — I guess he actually believes that nonsense, too. Sheesh.
Namste, one and all.
Nathan
Condor writes: “your dear pharma co.s do have already reserved funds to tap — usually the vast majority of such payouts DO NOT come out of “quarterly EPS” figures”
Absolutely correct. We don’t pull liability money out of our quarterly earnings. We stash it away every quarter into a “warchest” that is maintained to pay out on potential losses. In the case of Wyeth, that “warchest” was approximately $22 BILLION. None of that came from insurance — it came from our profits. Please correct me if I’m wrong. (Imagine having to pay for your civil liabilities out of your 401k rather than from your homeowners or umbrella policy!)
You also write: “Nathan’s FIRST comment in the thread would be comical — if it were not so tragic”
I assume you are talking about my placing more blame on the providor than on Wyeth. Do you place the blame for the Levine tragedy on Wyeth? If so, please explain why. It seems to me that 90% of the blame goes to the providor and maybe 10% to Wyeth. Yet the liability will come out the reverse (90% Wyeth, 10% providor) simply b/c Wyeth has deeper pockets.
Justice in MI
This is a belated response to Nathan’s post up-thread.
The reason that the Levine case was brought by Wyeth via the Bush Solicitor General to be the “poster child” for preemption was precisely because it _does_ obscure the real issues in preemption. It is clearly case (and I agree with this) that makes the company look relatively innocent - no accusations of cover-up, fraud, gross negligence, etc. - certainly as compared with fen-phen, baycol, vioxx, rezulin, et. al..
That was precisely the strategy. It is not Levine’s fault that Wyeth chose to appeal and that the preemption lobby was more than ready to help them do so. It was intended to be a “wedge case” to see how far in the preemption door it could be shoved.
Truth Hurts
Nathan,
It is a lost cause with these industry-bashing, lawsuit loving people. They really believe that the pharma companies are poisoning the public and that lawsuits are the way to riches and justice. The hysteria will die down as it did with the tobacco industry and they will move on to another industry to try and burn and destroy.
Nathan
Justice writes: “certainly as compared with fen-phen…”
I’ve asked this before, but this time you brought it up: Can you explain exactly what Wyeth did wrong in the case of fen-phen? I haven’t been able to dig it up. People were hurt, but I haven’t been able to find real evidence of wrongdoing. Yet Wyeth paid out $13 billion (and has another $9 billion ready for payout). This seems to be another poster child in FAVOR of preemption (and example of “lawsuits gone wild”)
Joe
Truth Hurts,
I hope you never have to experience the “truth”; I’m not sure you could handle it. The truth is, those who you call “these industry-bashing, lawsuit loving people” are people who have been harmed, or know people who have been injured or killed by an industry that uses an unamerican policy to avoid accountability. “We” are the people who are more concerned with justice than with corporate profit. We are the people who care about the erosion of our civil rights. We are the people.
Jim
Nathan
I am sure you are much more knowledgeable than me about the history of Fen-Phen and its introduction to the American market. However after reading your comments I conducted some research on this drug and if any drug is a Poster Child against the preemption doctrine Fen-Phen is the one.
The drug was approved by the FDA even though the FDA was aware of safety concerns that were raised in a European Study (IPPHS) prior to its approval by the FDA (link attached).
After its approval American Home Products (Wyeth) embarked on a massive marketing campaign and at its peak, prescriptions for Fen-Phen were being written at the rate of 85,000 per week, even though according to the link below some individuals in the medical profession stated that Fen-Phen should only be prescribed in cases of “moderate to severe obesity.” The link goes on to say that these recommendations were largely ignored.
In July 1997, researchers at the Mayo Clinic found that Fen-Phen may be linked to a rare heart condition and notified the FDA. During this same month Mary Linnen died from Primary Pulmonary Hypertension after having been on Fen-Phen for three weeks. This I believe is the answer to your question as to what did Wyeth do wrong? The risk of Primary Pulmonary Hypertension was previously known and despite this awareness Wyeth pursued FDA approval and the FDA complied.
On September 15, 1997 the FDA released what I would call a CYA statement calling for the voluntary withdrawal of Fen-Phen from the market. In the FDA release, the FDA does not mention any prior concerns about the safety of Fen-Phen and cites only the concerns raised by the Mayo clinic study.
Given your opinion that the pharmaceutical industry deserves a pass and that the medical providers should be held accountable, I must ask you, had it come to your attention that certain physicians were over prescribing a product that you sell would you feel compelled to refuse those sales?
In addition, why would you endorse a policy that leaves your distribution network holding the bag in the event something goes wrong with the products you sell?
http://www.fda.gov/CDER/news/phen/fenphenpr81597.htm
http://www.pbs.org/wgbh/pages/frontline/shows/prescription/hazard/fenphen.html
http://www.journalclub.org/vol1/a30.html
Note: American Home Products settled with the Linnen family for an undisclosed sum.
Nathan
Jim,
Thanks for the info. I really don’t know a lot about Fen-Phen, other than the fact that it cost Wyeth $22 bilion. From reading your post, I’m still not entirely clear on what Wyeth did wrong. Did they hide the cardiac tox info from the FDA? Based on your post, the only thing I see that they did wrong was to over-promote the product. Is that a crime worth $22 billion?
Ok, I agree that it is an example where preemption is bad policy. But it is also (in my mind) an example of why pharma is pushing so hard for it — how can 1000-2000 serious injuries/deaths be worth $22 billion, especially when I haven’t seen any direct accusations of deliberate coverups/fraud/neglegence, etc.
Nathan
I didn’t answer your questions:
You ask: “had it come to your attention that certain physicians were over prescribing a product that you sell would you feel compelled to refuse those sales?”
No. Doctors practice medicine. Pharma and insurance companies do not interact with the patient and hold no direct responsibility to the patient. (pharma’s responsibility is to adiquatly inform doctors of the benifits/risks of drugs)
Second question: “why would you endorse a policy that leaves your distribution network holding the bag in the event something goes wrong with the products you sell?”
I’m not sure of what you are asking here.
Lisa Van S
Paxil in children and Adolescents would have been a better option.
Jim
Nathan
You are welcome. As far as what Wyeth did wrong other then over promote the drug, I cannot at this time give a definitive answer.
There is a book about the woman who died titled “Dispensing with the Truth” by Alicia Mundy. This book chronicles the story of Ms. Linnen and her family’s legal battle with Wyeth. The gist of the argument was what did Wyeth know and when did they know it. I went to pick up a copy at the local Library but the Library was closed.
That being said, I do not know if Wyeth withheld any information from the FDA and judging by what I have read thus far it does not appear that they did, but when I come up with additional information I will let you know.
The fact is what I have read thus far does not condemn Wyeth as much as it condemns the FDA.
I will admit the system is far from perfect; I am sure that a large number of individuals jumped on the “me too” bandwagon in regards to Fen-Phen and three attorneys in Kentucky were charged with defrauding their clients in a Class Action lawsuit involving Fen-Phen.
However, these facts alone, at least in my opinion, do not add up to “Throwing the Baby out with the Bathwater,” which is essentially what a preemption doctrine will accomplish.
As to my second question: it goes back to your previous post where you state that “the liability should be with the PROVIDER.”
I did not read the JAMA editorial opposing preemption but I am sure that a large number of Doctors and Hospital Administrators did and they are your distributers; without them and their endorsement of your new products these same new products will wither on the vine, particularly since a number of new products are only minimally more effective then existing treatments.
Lisa Van S
Jim and Nathan,
Ed of Pharmalot, has covered the Phen-Phen issue for years. All you have to do is,.. ask him.
Nathan
Ok, Lisa - thanks. Ed, any insight? I’m trying to figure out what exactly Wyeth did “wrong” in the Fen-Phen fiasco. Was there some sort of coverup? I’m still absolutely astounded that Wyeth came away paying $22 billion when only a few thousand people were hurt.
Lisa Van S
Nathan,
do a Pharmalot search of “fen-phen” Lots to read. Im sure you will get a kick out of some the posts
Nathan
Lisa, I did that. There are dozens of posts about fen-phen - and not a single one mentioning ANYTHING that Wyeth did wrong. I’m thinking more and more that this fen-phen fiasco is a perfect example of why pharma is so strongly pursuing preemption.
As I keep asking repeatedly, how can $22 BILLION be an appropriate settlement for ~2000 serious injuries? This is “lawsuits gone wild”! Is anyone really suprised that we in the pharma industry are doing everything we can to stop this flood?
Condor
Nathan — I tried the longish format, but you side-stepped my central point. So, let me be terse this time around.
Where, exactly, do you suppose the funds for paying any third-party insurance premiums would come from?
Right — the same place as your litigation & claims reserves. So ours is a difference of degree — not kind.
The central point you refuse to address is that there SHOULD be some additional responsibilty imposed — when our legal system grants your products monopoly power. It is then appropriate to transfer risk to your company, as it receives the spoils of monopoly marketing muscle.
Please discuss.
Nathan
Condor writes “The central point you refuse to address is that there SHOULD be some additional responsibilty imposed — when our legal system grants your products monopoly power.”
Our responsibility is to be honest and forthright with the FDA and the public. If we meet that criteria, there should be no liability. Tragic things happen in life and sometimes no one is to blame. Science is such that we can’t always afford or forsee the correct experiments and studies to perform. From what I can tell with both fen-phen and with the Levine case, Wyeth fulfiled its obligations to the public and the FDA. If you have evidence to say otherwise, please post. I’m waiting.
Nathan
Condor, I’ll remind you that it is the US patent office that gives us this limited monopoly power. (to ALL industries - not just ours) The USPTO imposes no special responsibility on the patent holder to be liabile in case of failure of the patented product. Maybe you believe it is somehow a moral responsibility. I, however, do not.
Condor
Nathan — your monopoly products have one additional feature we haven’ t addressed, yet: they are opaque.
That is — we cannot know whether they work — thus, the FDA’s jurisdiction here. We have to trust your company — implicitly. Preemption won’t help us with that. We cannot live with a “caveat emptor” rule as to pharmaceuticals — nor should we — especially given your monpolies.
So, is it too much to expect additional warnings, and perhaps, extensive training for nurses — funded by the pharma co?
Jim
Ed
Care to share your thoughts on the Fen-Phen Litigation?
Justice in MI
Again, I am late catching up on the thread. The best book on fen-phen is Alicia Mundy’s, who is not a reporter for the WSJ.
I don’t want to summarize beyond staying that Wyeth was awaare of the valvular heart disease issues and managed to camoflage them in AE reports to FDA behind better known AE’s of the drug, especially pulmonary hypertension. The evidence shows, I believe, that Wyeth counted on FDA not finding the “needle in the haystack” given the nature of the ODS at the time. It worked. FDA didn’t. It was only after some principled people in Fargo, and evetually at Mayo, called a news conference that FDA was forced to look at the data which they already had.
This was a question of a company technically being in compliance but going out of their way (and successfully) to to divert attention from the camoflated info they submitted.
In my own view, it was about as despicable as such things gets. BTW, there were also some Congresspeople, including Tom Lantos, who played auxilliary roles in helping Wyeth maintain the charade. They are also, in my view, accessories to murder.
Nathan
Condor writes: “your monopoly products have one additional feature we haven’ t addressed, yet: they are opaque. That is — we cannot know whether they work”
That used to be true. From our previous conversations on this site, it is my understanding that all clinical trial data (from the last few years, and going forward) is now posted online. This is no longer a valid arguement.
Monopolies (patents) are granted in order to spur innovation. The monopoly is granted in exchange for publicizing information about the invention (in the form of a patent). In the case of drugs, I agree with you that this information should also include clinical trial data.
But that doesn’t change anything as far as liability goes. If a company is honest with the FDA and the public, there should be no liability for product failures and injuries. There’s an old saying “shit happens”. Sometimes no one is to blame for drug-injuries. Many people on this site (I’m not lumping you in there) do not seem grasp this point.
Nathan
Justice, thanks. So from your reading about the issue, is $22 billion a fair amount? Or vastly excessive?
Dianne
Nathan, I’m glad you brought up “tragic.” Following is an interview Jack Lessenberry did with Amanda Melpolder. It concerns preemption in Michigan.
Amanda gives a very good description of “tragic.”
“Jack Lessenberry Essays and Interviews: Interview: Amanda Melpolder - 3/3/08 - Includes audio with Amanda Melpolder (author of “A Tragic Blunder— Michigan’s Drug Immunity Law, Feb. 2, 2008 (http://centerjd.org/archives/studies/MIDrugImmunityF.pdf)”
Somewhere, somehow, someone forgot (overlooked) the words: “No person shall . . . be deprived of life, liberty, or property, without due process of law.”
Levine is not about Levine
Jim
If anyone is interested I have attached a link to a recently released report by the Center for Democracy and Justice who oppose preemption. The full report is 44 pages.
http://www.centerjd.org/archives/press/2008/081029.php
Jaynesday
Nathan, Up a few posts you made this statement - If a company is honest with the FDA and the public, there should be no liability for product failures and injuries. There’s an old saying “shit happens”. Sometimes no one is to blame for drug-injuries.
I would like to know if you think this is a commonly held excuse of this industry. I know you may not be a spokesman for it but do you honestly think this is the way at least some management feel about the workings of their operations?
Condor
Nathan writes: “. . .If a company is honest with the FDA and the public, there should be no liability for product failures and injuries. . . .”
This would place pharmaceuticals alone, on the vast landscape of American commerce. It is unwarranted — and it makes no public policy sense.
Moreover, to suggest that one may “read the studies, online” does little to reduce the “opacity” of drug products — at least as to about 97 percent of the American consuming public. In order to undrestand these studies, one muct be versed in the language, and nuances, of scientific discourse. And one must possess a very discerning, and scientifically- skeptical, point of view.
In addition, one must be able to sift through, and sort out the “NOISE”, the hyperbole — usually put out by the companies themselves (or doctors on “the pharma dole”), from what a given study actually finds — again, a tall task — even for most college-educated Americans.
We are watching — right now — the painful process of trying to get uniform DISCLOSURES from pharma — about which “thought-leaders” get paid for which “opinion pieces” each authors. ANd several, including Schering, have refused to do it voluntarily. So we will apparently end up needing MORE federal legislation — to “create the sunshine”, here.
That is what I mean by “product opacity”.
So, let us agree — your products are “opaque”. We Americans must rely on an “expert” — either the company, or our doctor, to figure out what is best for us. And, when things go wrong — after we’ve RELIED on these twin experts — BOTH PARTIES carry an affirmative burden to show they were free from negligence.
Having a “pure heart”, and an “empty head” has never been a good defense in American law — why should these multi-nationals be offered this break from at least 75 years of well-settled black-letter law?
You aren’t selling garden hoses, here — and you actually have TWO legislatively-created monopoly powers — FDA grants generally exclusive authorizations to sell new prescription medicines, right? So, along with this, and powered by the TWIN after-burners of patent-protection, the economic muscle of a novel, efficacious blockbuster drug is the envy of the capitalists’ world: a license to print money, and (usually) save lives, while doing so.
And so — it insults the intelligence of the readership, here assembeled, to use a reductio “shit happens” argument — to defend what would amount to placing drug companies ABOVE all other forms of American commerce — granting them alone, IMMUNITY from the consequences of medical errors. Sorting out causation for, and damages from, such errors — should be left to the courts.
To state your premise in this more honest way — is to REFUTE it. Please don’t tell me pharma will “die” without it. That is also palinly rubbish.
[Finally, note here that I have assumed -- without adequate evidence -- that ALL trials and studies are ACTUALLY reported to clinicaltrials.gov, and in a timely fashion.
But that, too, is a very-open open question, at the moment.]
Anne
I am sorry this case is not about Zyprexa, Lilly’s drug which killed or maimed 30,000 people. But most of the suits were mass tort settlements, with a large number of individuals stuck for life with diabetes, settling for approximately $10,000. It is now well-known that, before presenting this drug to the FDA, Lilly hid its lethal side effects. There were very few cases that went to state courts. Lilly was happy. I’m sure Nathan would be, too.
Try imagining, Nathan, how you would feel towards Lilly, or phrma in general, if it had killed your only son, and how you would feel about tomorrow’s SCOTUS case.
Justice in MI
It is possible that the Court will include some sort of “fraud exception” in a preemption ruling. This will be meaningless in any case, since the FDA/DOJ essentially never prosecute fraud - and certainly felony fraud.
So it will be “reassuring,” and serve good propanda for the preemption lobby, until folks realize it is yet more misinformation.
Condor
Ed — I trust you won’t mind if I go ahead and repost the portions of this fine discussion in which I’ve participated, almost exclusively with Nathan — on my blog. FYI Nathan, I tried to clean up my many, many typos, above (and the one or two of yours that I noticed), before posting — and reprinted it all, here:
http://shearlingsplowed.blogspot.com/2008/11/only-slightly-tangental-topic-drug.html
Let’s hope that — as one insurer’s latest slogan intones — “sanity makes a comeback” — after tomorrow (at the SCOTUS, and on 1600 Pennsylvania Avenue).
Namaste
Condor
An anonymous poster on my blog just offered this, after reading the above:
“. . . .An interesting debate.
Other items Nathan misses are: preclinical toxicology results, phase 1 clinical data and the ’slow’ (or under) reporting of adverse events once a Rx is approved.
Many of these never reach the public’s view. So, how can an uneducated individual ‘truly’ protect oneself without pursuit of a lawsuit?
To believe that Pharma is in the business to make people better is just not true. They are in the business to make money and improve shareholder value. They just happen to be in the field of making medicines.
And yet, we (as a society) don’t really hold accountability to a Dr (or ourselves) who uses a drug ‘off-label.’
Take a very innocent example: the writing of antibiotic Rxs for viral infections. Look at the recent web-story about Drs writing placebo Rxs. Just to ‘do something’ for the patient.
While nothing seems to be happening to the patient, it is now clear we’ve impacted/created the ‘drug resistant’ microbes.
November 2, 2008 10:34 AM. . . .”
Nathan
Condor, I’ll have to post more later. I still disagree about the opaqueness issue. The public is not (and cannot expect to be) experts on ANY technical issue from the design of aircraft, automobiles, anticancer agents, or home heating systems. We rely on “expert opinion” all the time in every area of life — pharma is not unusual in this regard.
Now, I’m still waiting for a straitforward answer from you or Justice (or any other anti-preemption person): IS THE $22 BILLION PAYOUT FROM WYETH (ABOUT FEN-PHEN) AN APPROPRIATE SIZE?
This is a very legitimate and central question. THIS ONE CASE in a nutshell is why preemption is being pursued. This industry can’t survive if we have $20 billion liability lawsuits continually hanging over our heads.
FDA Reviewer
Other things that the public is not aware of is that FDA reviewers are routinely harassed for questioning drug companies about their data or for even for requesting absolutely essential data or studies.
Reviewers who persist and stop a drug for safety reasons are harassed, officially reprimanded, and warned not to make any more trouble or they may be fired.
For reviewers (especially non- M.D. reviewers) who have not done research for years this means that after finally landing a permanent job after years and years of post-docs and temporary jobs that they are effectively blacklisted from any pharmaceutical job and their research skills are too dated to go back into the lab or to get an academic position. (i.e. spend 20 years in training, work in your field for 10 years, and then lose everything.)
Forget about Congress, if FDA management even thinks you may have gone to Congress it means you’ve got a target painted on your back and you’re gone as soon as they can set you up.
FDA management is only too happy to call up drug companies when reviewers find these safety issues (even when it’s specifically prohibited). And then insider trading occurs.
We reviewers follow the stocks on the drugs during reviews and when stcok prices repeatedly drop by 5 or 10% a day or so after safety issues are found it’s pretty clear what’s going on. When the managers who make these phone calls leave FDA (retire etc.) they then get lucrative consulting jobs.
There are drugs out there right now that FDA management is protecting that will likely result in more than the 60,000 Vioxx deaths and
bigger liability than the $13.1 billion for phen-fen. Why else do you think a company needs a $22 billion dollar liability fund. If they didn’t think that there was actually liability there and they might lose. Remember Vioxx only resulted in a $4.85 billion settlement.
By the way the zoloft OCD study in children resulted in several deaths on drug due to suicide and none on placebo. Even if it does improve the response over CBT alone the additional benefit may not be worth 1% of kids dying.
Condor
Nathan writes: “The public is not (and cannot expect to be) experts on ANY technical issue from the design of aircraft, automobiles, anticancer agents, or home heating systems. We rely on “expert opinion” all the time in every area of life — pharma is not unusual in this regard. . . .”
Odd. I guess I’ve forgotten where the “preemption is the law of the land” 18 U.S.C. Sections and/or case-holdings are — for autos, for aircraft and home heating systems.
Oh. Right. Silly me.
THERE ARE NONE, Nathan.
Game. Set. Match.
Your own argument just proved far too much, just then.
If Wyeth has its way, pharmaceuticals WILL be unique in all of American commerce.
QED
Jaynesday
Nathan, I guess I’ll try to answer your $22 Billion dollar question. Forgive me I will make a number of assumptions, having no details about the progression of the case and settlement. It appears that no one else on this site really has that information either. But here goes.
I would say if it takes $22B from keeping another Fen-Phen from happening again, Yes it is appropriate. I would have to assume it took a number of learned people, not just jurors, to decide what was appropriate and would be meaningful to Wyeth.
Also turn it upside down (which is what preemption wants to do). What if Wyeth perpetrated the same thing and there was no consequence, no accountability?
What if we lived in a world where multi billion dollar corporations existed that could, if they wanted to, design and sell drugs that were no better than placebos but promised us that their studies showed it could heal terrible illnesses. Furthermore what if that medicine actually caused the death of thousands and injured 10s of thousands. Then what if that multi billion dollar corporation could thumb its nose at it’s customer when they complained - “Hey we trusted you with our lives and the lives of our children, our families and friends and instead you took them from us”.
Personally I prefer the $22 Billion dollar option. And if Wyeth is caught doing something similar in the future (What?) it would be obvious then that $22 Billion wasn’t enough.
Justice in MI
Missed the 22B question, but what I wonder is what has Wyeth actually paid out in settlements or otherwise re: fen-phen.
Otherwise, learned recently from a reliable ‘insider’ that Merck - like other companies in such circumstances - had precise calculations about when to pull Vioxx based on earnings and projected liability. The APPROVe trial happened to fit right in to relevant charts and grafts.
Some have suggested that Merck would have faced less liability had the kept Vioxx on the market. Their own projections showed otherwise. And so, of course, did the result, in which they did quite well under the circumstances.
Too much? Five billion divided by 50,000 deaths, minus cut by lawyers equals about 6K per surviving family. That’s the cost of a moderate funeral.
Nathan
Justice writes: “I wonder is what has Wyeth actually paid out in settlements or otherwise re: fen-phen”
The answer: $13 billion so far. They anticipate an additional $8 billion before it is done. This comes to about $100,000,000 per live lost. Rather steep?
Nathan
Condor,
In case you missed it, I’ve never been a complete advocate of preemption. (reread my posts carefully) I’ve gone back and forth on this issue. I understand the need for recourse in the event of unethical behavior by pharma (which has clearly happened). But the current system is out of control. You never answered my $22 billion question. I’ll ask you again, I feel deserve an answer from you: IS THE $22 BILLION PAYOUT FROM WYETH (ABOUT FEN-PHEN) AN APPROPRIATE SIZE?
I don’t think it is any coincidence that the company that was so unfairly treated in the Fen-Phen fiasco is the same company bringing this challenge to the supreme court. Employees & shareholders are tired of being slapped around unfairly by the court system. As I’ve said before, preemption may swing the pendulum too far in favor of the corporation — but the current system is swung was too far in favor of the plaintiff.
Condor
Nathan — should it matter at all that it was marketed as a “diet pill” — and it was apparently inherently dangerous?
This gets directly at my point about the opacity of such drugs — what is it, exactly, you think these people SHOULD have done to protect themselves?
When their doc wrote the ’scrip, wasn’t the doc permitted to assume that the pharma co. had done its homework — before putting it
on the shelf?
I dunno. I think making something people DON’T
necessarily NEED to take — a vanity drug, if you will — and then it turns out to be dangerous (and, perhaps, in a way previously-suspected by the pharma co.) — should cause steep settlement numbers.
But that’s just me.
Cheers!
Nathan
Justice writes: “Five billion divided by 50,000 deaths, minus cut by lawyers equals about 6K per surviving family. That’s the cost of a moderate funeral.”
That’s funny Justice — I assume you are writing tongue-in-cheek?
1) $5 billion / 50,000 = $100,000. Do you really think lawyers take 94% of winnings? At that rate, the lawyers make $4.7 billion out of the $5 billion settlement!
2) Where do you get the 50,000 deaths from?
3) Even if the 50,000 deaths is accurate, can you REALLY attribute all of that to bad behavior by Merck? I’ll ask the same question I did of Wyeth: What exactly did Merck do wrong here? The main controversy is about the NEJM paper. This was really a case of scientific misconduct in my mind. All the negative data was available to the FDA and publicly posted on the FDA web site. Had the NEJM article been written correctly, sales of Vioxx would have been lower — but the drug was still approved and would have been used.
(see link here for background on the NEJM paper)
http://content.nejm.org/cgi/content/full/354/11/1193
Nathan
Condor,
You can call an obesity drug a “vanity drug” if you want, but obesity is now recognized as a top cause of premature death in the US. See this link.
http://www.doctorslounge.com/primary/articles/obesity_death/
I’ll take your terse response to mean that your answer to my $22 billion question was “Yes, it was an appropriate payout.” In that case, the discussion is over. We’re too ideologically far apart to even find some common ground. I respect Justice’s opinions in these matters because he at least recognizes that the current system is not quite working right. Preemption may not be the answer, but THERE IS A PROBLEM WITH THE CURRENT SYSTEM. If you don’t agree, then it’s pointless continuing our discussion.
Nathan
Condor, let’s return to the topic at hand: You haven’t addressed the real issue in Levine. You keep talking about preemption. Let’s talk about the Levine case: Where does the liability lie? Do you agree that the doctor is more at fault than Wyeth? Do you really believe that Levine’s injury was Wyeth’s fault? That’s the root issue here — and that’s the basis on which the supreme court will issue an opinion.
Justice in MI
“What exactly did Merck do wrong here?”
Read Ed’s interview with Tom Nesi from a few months back. For starters:
- Ignored two FDA warning letters of the most severe kinds for mispresenting Vioxx to docs. FDA said Merck’s stuff was endangering public health.
- Used a series of strategies to intimidate academic medical researchers and threaten academic medical centers.
- Continued to argue that naproxen was cardioprotectice (post-VIGOR) when it was pretty clear no one at the company actually believed that - and especially not Ed Scolnick.
- Had one of their folks doing stats for the VIGOR oversight board - illicitly unblinded data during the trial, probably prevented it from being stopped when it should have because it would have “killed the drug.”
- Continued to misrepresent the stats of the APPROVe study (the eighteen-month myth) well after they knew numbers were bogus .
- The more they became aware of mechanism-based CV risks, the more heavily they promoted drug.
- According to NESI, also suppressed two Alzheimer’s study that showed a statistically significant _worsening_ of AD among pts taking Vioxx.
As above, for starters.
Justice in MI
Nathan writes: ‘Do you really believe that Levine’s injury was Wyeth’s fault? That’s the root issue here — and that’s the basis on which the supreme court will issue an opinion.’
Actually, it isn’t. Otherwise, it would just be a regular liability suit. The SC is not deciding the merits of the original suit (which most of us agree are not the strongest). Wyeth and preemptor buddies decided to appeal _specifically_ on the basis of preemption. So that’s what the SC will be deliberating about, much more than the particulars of this particular case.
Justice in MI
p.s. If the Solicitor General and four Justices did not want to issue a ruling specifically on preemption, they never would have granted cert. (agreed to hear case) in the first place. They are not a last-ditch appeals court unless there is some major policy or Constitutional issue involved. In this instance, it’s FDA preemption.
Nathan
Thanks Justice — insightful as usual.
I know I’ve asked this before, but I’ll ask again: If it’s so clear that Merck was in the wrong on so many issues, would preemption REALLY stop lawsuits? What if they were found to be criminally wrong on some of the above issues you mention? Wouldn’t that open up the possibility of liability?
I think I know your answer, I just still find it very hard to believe…
An FDA Reviewer
Nathan,
How is anyone going to be able to show that criminal actions have occurred.
There’s an FDA reviewer who recently documented criminal activity by a drug company (covering up deaths in phase III studies) and and is in the middle of being fired for reporting it.
FDA management even documented the reasons for the firing as being that the reviewer was going to go to the FBI and to Congress.
An FDA Reviewer
Jaynesday
What’s the worst that could happen today?
1. Preemption is denied – We go on as before with a somewhat problematic torte system that does need improvement. Pharma has to continue to factor in the possible increased cost of their product due to the fact that they will need to sacrifice some percentage of their consumer’s health and well being. Given the uncertain nature of their product’s design and testing it just can’t be helped. If we want great new blockbuster drugs we’ve just got to suck it up.
Who wins – No gains in this scenario
Who loses – the lab rat
2. Preemption is allowed – A brave new world. I say brave because you really will need to be brave to take a new pharma product in this new world. It was risky before but the risk factor just doubled for new drugs and devices. The consumer has no recourse in this new world and the manufacturer is free as a bird to soar to new heights of ….. TBD.
Who wins – the industry machine. Lets see if we get inundated by new blockbusters that they’ve been holding on the shelf for a “less risky” environment.
Who loses – the consumer x 2
atlex
All,
Don’t expect anything to happen today except for the case to be argued. This case is unlikely to be read out until sometime after the beginning of the new year.
Atlex
Condor
Nathan — I am willing to let the courts of our nation decide which party or parties (the docs, nurses, hospitals, the ER transport team, or the drug manufacturer — or NONE of them!) is more or less negligent when a patient is injured — that is not an “all or none” game — juries and judges find various parties “comparatively” negligent or not so — all the time.
Damages are then split up among the parties relative to their comparative negligence.
You’d simply give pharma a pass. I won’t. So we are pretty far apart, Nathan. I will concede that much.
As to obesity — I imply no value judgement.
I simply remark that most people seeking damages took it believing it was a “safe and effective” diet pill. The safe part no longer seems so clear. I think the courts should be allowed to sort it out.
We’ll see what comes when Levine is published next Spring sometime — but we’ll get a “Kentucky windage” today, from some of the Justices questioning — and argument, among themselves.
Cheers!
Former pharma Marketing Exec
I would like to thank the FDA Reviewer for having the courage to post your comments here.
You have been most helpful and insightful.
Most of the things you have said, we have guessed, you are helping us all by confirming what we already suspected.
Most of the drugs being produced today are expensive band aids. Not only are the patients/consumers being ripped off, the drug companies are ripping off themselves. We do not yet know what causes most illnesses, so, no one is immune.
The amount of money that is being spent on drugs that are not as effective and safe as they are touted to be diverts lots of money, time, and research away from meaningful work that could really help more of humanity.
This is why there is a “former” in my moniker.
Anyone who tries to do the right thing in the pharma world will be harassed into oblivion. We have learned here that it wold seem that the extent of corruption in this business goes beyond anyone’s imagination.
The more people continue to take/ buy drugs, the more Pharma will have the money to manipulate our government system and take rights away from “we the people”.
If you are not on any “life saving” drug (there aren’t many of those anyway) stop buying/paying for any of these.
Maybe we should start a Drug Free America day, week, month etc…
If we are being treated as consumers, then we should show the power we have as consumers.
Eat well, exercise well, sleep well and stay away from Pharma…
Justice in MI
Nathan - Thanks for the question. The original Michigan law had what is called a “fraud exception.” So, if we posit that Most of Merck’s actions as listed happened, even these would not constitute felony fraud (deliberate withholding of info) as legally defined. Thus preemption wouldn’t apply.
But let’s look at the case FDA review mentions in which, as described, bodies were hidden. That clearly would be felony fraud. It is quite possible the SC will end up deciding for broad preemption but include some version of a “fraud exception.”
The problem is the one we have often discussed. For a ‘fraud exception’ to kick in, FDA/DOJ have to have carried through on a criminal prosecution of felony fraud. Settlements, remedial plans, fines for lesser charges, label changes, drug withdrawals, confessions to misdemeanors - none of that would count. Which leaves …. essentially nothing. So, since FDA/DOJ basically _never_ prosecute fraud in a context relevant to labeling and compliance, a “fraud exception” would be, in practice, meaningless and full preemption would be apply.
Meanwhile, in the Kent case, FDA/DOJ argued that preemption should apply even if there _were_ such prosecution!
That, by the way, is precisely what has been the case in Michigan. Total black out on civil liability since our law was passed in 1995.
Justice in MI
whoops - last sentence of paragraph 1 should have been preemption _would_ apply.
Juryman
A View from the Jury Box
While realizing this case hangs on a point of applicability of law, I thought it might be useful to share a bit of the view as on on the original jury in this case.
My background is healthcare management and I also have worked with a law firm specializing in defense of medical malpractice.
When entering the jury room. Less than half the jurors, including myself, were ready to return a plaintiffs verdict. We spent and exteneded period of time reading the many documents entered into evidence ranging from actual package insert to many internal Wyeth findings and communications.
A few things became clear:
1. All FDA expert testimony, plaintif and defense agreed the package insert could be changed at any time on an expedited basis to add to warnings.
2. The package insert allowed for IV push administration.
3, Tissue death could be induced by interstitial administration not just inter- arterial meaning a needle wandering throuh the wall of the vein or drug leaking around a needle could have this result. This was not clearly explicated on the insert.
4. Wyeth had known about this problem and the consequences for decades and had done nothing, not even a simple “Dear Doctor” letter to communicate the risk to doctors.
5. The insert was the original insert from the introduction of the drug still in use at the time of the incident under a grandfather clause. It was being updated, but the warnings were not being changed at the time.
6. The award contained no punitive element. None was asked for and none was given despite the desires of some more extreme jury members. It was based on a life care plan. Due to my previous experience I tended to view such things skeptically but this one was probably optimistic based on medical information revealed at the trial.
7. The head of the clinic involved acknowledge responsibility both in a settlement and in testimony at the trial.
What would have prevented a plaintiff verdict? Almost certainly any act by Wyeth that attempted to communicate with the medical community a need to take a higher degree of care in the administration of this drug.
WY
The problem with the original Wyeth settlement is that the individuals on the commercial side that were responsible for the tragedy got away with it. In fact, they went on to create more of the same at Pharmacia (HGH, Celebrex) and now at Schering-Plough (Zetia, Vytorin). The major question is “will they ever be held accountable for any of these or will they continue to avoid responsibility and retire rich?”
An FDA Reviewer
Former Pharma Marketing Exec
While I agree with many comments I’ve read from the people in the pharmaceutical industry that many drugs are simply me toos and money would be better spent finding new drugs. I’m afraid that that’s naive.
From what I’ve seen many of the toxicitites that kill drugs either during development, during the review, or even post-marketing appear to be the same things over and over and also appear to be mediated via similar final common pathways within cells. These alterations in these pathways are also the likely cause of many diseases. Thus it may be impossible to get develop drugs without serious problems.
Industry develop the best new drug that they have in their pipeline and they need to keep growing and replacing lost sales. So if they don’t have anything better they have to try to bring to market an unsafe drug. This is a problem for the entire industry and one reason why they need preemption.
I’ve thought about many alternatives such as extending patent life, etc., every alterantive I’ve come up with has inherrant flaws.
I might be in favor of preemption if companies would be honest with us. We actually did our jobs ethically at FDA and we could lay everything out in a public forum at the appropriate times so that the public has a true voice in the level of risk they’re willing to take. Instead of having FDAers being paternalistic and who have finacial biases (post retirement) or are simply biased because as professionals they are more used to accepting high levels of risk because they’ve become immune to the consequences. However I’ve actually heard senior FDA officials and Division Directors discussing how they were going to get the head of an advisory committee to sway the other members in a company’s favor. Where in spite of observing the head of the AC trying to direct the discussion and vote it was only by the reviewers making a such a strong argument to the AC that it didn’t occur and the drug wasn’t approved.
I’ve also heard senior FDA officials indicating that drugs need to be approved due to instructions from the White House, and they have been.
Juries not only evaluate the facts as to whether the science was actually presented, etc. but they also give us an interpretation on societies value judgment as to acceptable levels of risk and warning. No scientist nor even a single public member on an advisory committee ever do this.
In fact no single jury can adequately do it, it’s only by multiple jury decisions can we come up with a general idea of the level of risk society is willing to accept.
If people here really want to find out what’s going on then you need to have Congress look into the case I described of the reviewer that’s being fired.
If this is occurring why hasn’t Congress held the people who have retaliated responsible.
Write Dingell, Stupak, Grassley, the winner of tommorrow’s election. The senator’s from Maryland where FDA is located and the Representatives who represent most FDA reviewers, e.g. Chris Van Hollen.
I’m sure they can find out any reviewer who has or is in the process of being fired.
Also contact the FBI and the Justice Department and ask them to look into it. If this is true then it’s possibly witness tampering by FDA officials.
Otherwise this reviewer will be fired and will never be able to speak because too many things are ‘trade secrets’.
Jim
Juryman
Thanks for the insight. It made me think of another possible outcome; the Supreme Court upholds the Jury Verdict Award because it predates the FDA regulatry change but holds that the Preemption Regulatory Change was within the scope of the FDA’s authority.
To Former Pharma…
I could not agree with you more; individuals should only take those drugs that are necessary, the only problem is the Medical Profession continues to prescribe drugs to their patients and tells them they are necessary.
There is also the flip side to this argument and that is people would rather take a pill then alter their lifestyle. I know several diabetics who take their medication but have done nothing else to alter their lifestyle.
Condor
One technical note on the post by “Juryman”, above:
If memory serves, there was no path through the applicable state laws for a request for punitive damages in the original Levine case.
That is why the lawyers for the plaintiff sought no punitives.
But one question: How on Earth did the lawyers for the plaintiff let a guy with med mal defense experience get seated in the jury box?
I am puzzled. Very interesting — were the OTHER potential jurors worse choices — for the plaintiff? Wow.
Odd. Now, to be clear, “Juryman” — it seems you did an excellent job — but it would make logical sense that the plaintiff lawyers would want to exclude you — so that your experiences did not lead the jury beyond the evidence (or to disregard the evidence) offered.
Kudos!
And, namaste.
BILLYBOB
I’m very interested in this preemption argument because I’m currently involved in a lawsuit regarding my use of an FDA approved medicine. AstraZeneca produces a nasal inhalant called Rhinocort (budesonide). It is a corticosteroid for chronic nasal allergies that promotes easier breathing. My physician presribed to me due to snoring issues that kept my wife awake at night. I took the drug for 18 months, and within 24 months, I was legally blind. AstraZeneca never put any warnings on their product that use of corticosteroids were associated with cataract formation. The type of cataract most closely associated with steroid use is Posterior Subcapsular Cataracts, which was exactly what my diagnosis was. Doing a little research, I discovered that there were more than 50 years of associational studies indicating that corticosteroids were linked with cataract formation. Even the Merck Manual states that cataracts are often formed by corticosteroids.
I sued in state court, but the defendants had it removed to federal court.
My question to Nathan (since you seem to be the pharaceutical rep here) is do you not agree that AstraZeneca is liable ?
Jaynesday
Very interesting posts here, I learn new things every time I read. Thanks Ed.
What struck me upstream is the input of Juryman; an aspect of this issue that we’ve not explored much.
Forgive my normally simple take on this – If we will allow a product on the market that the public will have to bear *any* burden of harm for, we *absolutely must* allow:
1. all citizens the right to bring suit when the product does harm
2. a jury made up of that same public the opportunity to hear the case and weigh the merits
To do anything less than this is uncivil and demeaning for the citizens of our free country. By not doing this we elevate industry above the citizen and we tarnish the edict that we shall have the right to life, liberty and the pursuit of happiness. This is not what our forefathers had in mind when they wrote the constitution.
I understand the issue of “the greater good” – the fact that our drugs and devices help more that they hurt, but if *any* are hurt (even one) you can not take away the right to protest before our peers. The natural progression of this kind of thinking is that we should weigh the “value” of each citizen and when there is a grievance between two citizens the one with more “value” wins.
Justice in MI
FDA reviewer - As you well know, some number of FDA people (not just those cited in Waxman’s report) have taken the initiative with their actual identities to comment on the realities of the compliance/approval process to relevant Congressional contacts. i am not asking you to do this!
However, I am wondering if you can tell us whether there is movement in that direction under the protection of subpeona. My understanding is that there has been. Can you confirm?
Thank you.
Former pharma Marketing Exec
To The FDA reviewer.
I agree with what you are saying, and I know firsthand the complexities represented in drug development. We do not know all there is to know about any given disease, yet we are trying to make drugs that treat certain aspects of it.
It would be great if Pharma would be honest with you. I think all of us agree that if we were all dealing with one another on an honest basis, we would not be so embroiled in such difficult discussions.
Humanity is based on trust, and we have all played a role in eroding the foundation of trust so necessary. It is what I have termed the “perfect storm”.
More importantly, we should all consider the vulnerability of the patient population we are supposed to be serving.
What is it like to be at the mercy of a very flawed system. What is it like to be told that you have in many cases,a serious illness and you must depend on a drug or service of some kind.
- we need to know more about the FDA reviewer who is being fired for doing his/her job. This is completely unacceptable and the public needs to know the extent of the corruption in a government office. We are not a third world country!
To the juryman, it is interesting that you made it to the jury given your background - sometimes things go right I guess. To all who have read his comments, ask yourselves, what is the intentions that were behind the lack of attention and priority to update the monograph and inform the medical professionals using the drug of the seriousness of harm that could be caused? The doctors and nurses who use this drug should be outraged. The anxiety it causes them to know that after years of careful training they have done what they pledge not to do, they have caused harm. It could have been avoided had Wyeth in this case done the right thing.
If we in Pharma do not take equal responsibility to “do no harm” then we shouldn’t be in the business of making drugs and selling “cures”.
To JIM. The very reason why people rely on drugs rather than change their lifestyle is because that is what we have taught them.
When you go to the doctor with high blood pressure, very rarely do you get a consult for a health and nutrition expert and lifestyle coach. The first thing they do is reach for the Rx pad (that has our logo on it) and start earning their “frequent flyer” rewards.
We created this mess - it is up to us to fix it.
Informed consent is the right of all people. If I am being asked to comply or pay for access to drugs or treatment, then I must be told everything.
None of us should be satisfied with a “need to know basis”. The argument is always that the patient cannot possibly understand all they need to know. That does not mean that anyone can filter information and make broad assumptions. Patients who want to know will, and those who want to learn will, but the decision to do so is theirs. Give them everything, and let the patients decide.
Wyeth “duped” everyone. They duped their customers - the doctors and nurses they sell the drug too, they duped the FDA, and the patient was harmed because of it.
What was their intention? That is what has to be brought to light here.
An FDA Reviewer
Pharma Marketing Exec.
I’m going to restate. If people want to know what’s really going on, then people from this blog need to contact Congress about this reviewer. If Congress finds out that it’s now public maybe they’ll actually look into it and the safety concerns this reviewer was raising why will come out.
It’s fairly common knowledge at FDA that the reviewer is being fired. Management had the reviewer physically escorted from the building for being an imminent danger to others, but this is based on the reviewer standing up to management in an open forum in front of a couple of hundred other reviewers several months earlier. I wouldn’t call a 3-4 month delay an imminent threat. On one of the occasions the reviewer challenged senior management’s assertions that no one is ever pressured to complete reviews when they don’t have enough time and management’s openly stating that anyone who claims they don’t have enough time is just lazy and a complainer.
I believe that management openly having the reviewer escorted from the building by security is a blatent effort at intimitation of the rest of the review staff.
As for Kindler and updating FDA science, it’s also interesting all the Pfizer people who came to FDA over the past several years and were promoted into management positions after only a year or so. One person who congress has implied they’re watching is Bob Powell. Dr. Powell was a VP at Pfizer and came to FDA as a low mid-level manager. He also worked at Pharmacia and Glaxo and is responsible for automating adverse event reporting etc.. (Remember the miscoding of safety at Glaxo). He’s also involved in the Pharmaceutical Research Institute Congress is afraid will have too much say over FDA, Drug-Disease modeling, the critical path initiative and updating the computer systems and datamining that Kindler and Pharma are so interested in.
Another person is Gwen Zornberg MD, ScD who worked on antipsychotics at Pfizer and then was promoted to management in Pyschiatry after only a year at FDA.
So even if anyone tries to clean up FDA, like the Hydra the replacement heads are ready to take their place.
There are others but these are the ones whose backgrounds are public knowledge and it’s a violation of FDA policies to discuss the work history of people at FDA if they are not publicly known.
Jim
To FDA Reviewer
Is the employee who is being fired covered under the Merit Systems Protection Board?
An FDA Reviewer
I would assume so. However not only has MSPB not been standing up for people under Bush but the very fact that our government would fire people for talking to Congress especially after Congress admonished FDA Commissioner Von Eschenbach about this previously with other reviewers is unacceptable.
It smacks of intimidation for engaging in first amendment activities.
Even if MSPB does do something it may take years.
I’m afraid if Congress doesn’t do anything quickly then no matter what MSPB decision there is down the line people will be even less likely to come forward and it will also encourage even greater harassment for political reasons within the FDA.
It will also encourage drug companies so that they will think, yes we can get away with anything we want to.
Former pharma Marketing Exec
Thanks FDA Reviewer,
I really hope people here will speak up and write to their congressmen over this issue.
This is unacceptable and again shows that our rights are being eroded.
Thanks for speaking up, we shouldn’t let this drop.
An FDA Reviewer
Thank you Former Pharma Marketing Exec
After I posted I thought quite a bit about if I was too strong, and if it would be better to let MSPB take care of it. I decided I wasn’t too strong at all.
Much of this election is about change in how things are done in Washington.
If MSPB takes care of this down the road say in a year or two and the reviewer is vindicated. What about in the interim? Is the reviewer fired? Did the reviewer lose his house because he’s blacklisted by industry and can’t get a new job in this economy. Has the stess resulted in Divorce? Has the reviewer taken another job and moved away, so he won’t come back and FDA can put a dangerous drug(s) on the market at will kill 10’s of thousands before it’s caught again. Will FDA instead pay this reviewer off in order to be quiet and so that an extremely dangerous drug will be allowed to kill people.
The firing is only the culmination of years of increasingly severe harassment for this reviewer. Even if the reviewer comes back, I’ve been told that the harassment will likely only get worse in order to try to get the reviewer to quit.
Congress previously told Von Eschenbach that FDA managers would not be paid if they engaged in whistleblower reprisal. They said this multiple times. David Graham was going to be moved out of his position after he testified on Vioxx and Congress had to step in. He then went on to get Bextra off the market. However Andy Mosholder who identified antidepressant suicidality was forced to move to postmarketing surveillence from the Psych group and Victory Hampshire (Proheart 6) also had to move. Consequently they’re no longer working in the areas where they have the most expertise and can do the most good.
I think for Congress to have warned FDA management multiple times and especially in the present atmosphere of Congress claiming that they want change and are going to exert their oversight responsibilities to not hold managers in FDA visibly responsible will only send a message to all the industry plants in FDA that Congress has only been blowing smoke and as soon as the smoke clears it’s OK to get back to business as usual.
An FDA Reviewer