The Blame Game: Zyprexa Judge Blasts The FDA
25 CommentsBy Ed Silverman // July 22nd, 2008 // 7:56 am
During a hearing last week on the sprawling litigation over Lilly’s antipsychotic, US District Court Judge Jack Weinstein decided to have his own day in court. In a few short minutes, he let loose a stinging rebuke of the FDA’s role in allowing Zyprexa on the market, despite persistent allegations that such side effects as diabetes and obesity were hidden, causing the government and insurers to overpay.
“Compared to its peer agencies in other parts of the world, the FDA has arguably failed consumers and physicians by over relying on pharmaceutical companies to provide supporting research for new drug applications; by allowing them, through lax enforcement, to conduct off-label marketing; by acquiescing to industry pressure on drug labels; by not requiring doctors-the main line of defense against misusing prescriptions-to be adequately informed; and by leaving information dispersal and control largely to industry-influenced medical journals and non-governmental associations. The result of such claimed governmental failures arguably causes overuse and overpricing of pharmaceuticals, resulting in mass litigations such as this one for Zyprexa.”
And he had some words for others who ensured the drug was widely used. The mountains of document “could suggest to jurors inadequate controls of the pharmacological research, distribution, delivery, use and payment systems in the US: failure of the federal and state protective agencies upon which users of pharmaceuticals primarily depend to protect against overpricing and misuse, and, in particular, the FDA’s lack of adequate research and control over marketing; failure of third-party payers, pharmacy benefit managers, and their consultants to exercise control over drug pricing and use; failure of what should be impartial and timely research by governmental and non-governmental organizations; inadequate steps by governmental and non-governmental organizations to promptly publicize efficacy and dangers; and, to some extent, failure of prescribing doctors and other medical personnel to limit appropriately usage and costs.”
But Lilly was not exempt, in his view. “Lilly’s alleged lack of transparency, failure to warn, and deceptive or illegal marketing practices are but some of the factors that a juror could find led to this litigation.” And he went so far as to say there is “some merit” to the allegation that “Lilly exaggerated the utility of the drug, both on and off-label, and de-emphasized its dangers, in order to support an excessive price. Evidence of defendant’s alleged failure to disclose its products’ side effects, its violation of obligations of transparency, and its deliberate encouragement of off-label use, permits-but just barely-a jury finding of liability under RICO.”
There’s more if you want to look here.
Dan
The D.O.J. is just as much in collusion with the pharmaceutical industry as the FDA, in my opinion, so the statements in this post are difficult to absorb or believe.
Justice in MI
Dan - Can you elaborate? If the DOJ was also involved, why would that make the rest hard to believe?
Personally, I do believe that lax enforcement through the FDA’s Office of Criminal Investigation, which works in concert with DOJ, is part of the problem. To me, that’s consistent with Judge W’s statement which refers to “lax enforcement” in general.
Jack2
JIM,
Slightly off topic, but it’s about your favorite topic:
I read yesterday that the current proposals for preemption would exclude fraud (meaning someone could still sue for fraud). Is this your understanding of preemption.
Ima Misfit
Thank you Judge Jack Weinstein!
At least there’s one person within the Judicial branch who understands the corruption and fraud that has plagued the healthcare industry for at least three decades.
While there are certainly many others within the Judicial and Legislative branch that understand the issues, almost all are in the pockets of big pharma and will do nothing to fix the disgrace of a pharmaceutical industry that exists in the U.S.
http://americanfraud.com/default.aspx
Nathan
Jack2, can you provide a link? I’d like to read about preemption someplace besides this website. It seems that no one else out there is talking about it, positive or negative! It’s hard for me to believe that it could have such earth shattering consequences when the mainstream press is utterly silent. Not only that, you would think that financial analysts would be talking about the financial impact of such a “major” decision — but I hear only complete silence on the issue on almost all fronts. (except this website)
Jack2
Relevant text:
Michigan, where the case was first brought, is one of a handful of states that have laws granting FDA-approved drugs protections against liability suits, except when the approval was obtained by fraud.
…It’s worth reading the whole article though.
Linky:
http://pharmexec.findpharma.com/pharmexec/Rotating+Features+Article/Pharmas-Day-in-Court/ArticleStandard/Article/detail/529151
Justice in MI
Hi guys (and gals) - Jack2, you did, indeed, zero in on a key issue and one that got me started in all this.
Our 1996 Michigan law, as originally written, did have a “fraud exception.” However, in a few key cases - most famously, one called Buckmann - the Supreme Court ruled that only the FDA can find fraud against itself, not state courts (and thus not individual plaintiffs).
Thus, for this to be relevant to Michigan’s law, there would thus have to be (a) a successsful felony fraud prosecution by FDA/DOJ and (b) [in the language of the Michigan statute] the relevant drug “would not have been approved or would be withdrawn” if the data had been accurately submitted.
As I learned through a FOIA to FDA as well as my own research, there have been ZERO cases in the past twenty years that meet Michigan’s criteria, which are actually much narrower than fraud alone. This has largely to do with settlements (with no “admission of guilt”), remedial plans, deal-making, etc. all of which head off the kind of fraud prosecution that is required.
This was also the issue in Warner-Lambert v. Kent cited in the article. Was Michigan’s “fraud exception” itself preempted by FDA (because only FDA can find fraud against itself). Although the Court split 4-4 with Roberts recusing, the facts above still hold.
Meanwhile, in the DOJ/FDA brief in Kent - and this is the position of those championing preemption - the core argument was that an FDA/DOJ finding of fraud (if one should happen!) should _not_ serve as a gateway to civil litigation. As you’d guess, the core of that is the “open the floodgate” argument.
So, as things stand, there is no meaningful fraud exception either in Michigan or in preemption as it is being advocated nationally. It is _conceivable_ that a Supreme Court ruling would suggest there should be, but - given the current court - that is also very unlikely in my personal view.
Re: Nathan’s post, I could not hope more that there be more discussion in the media - the more the better, as far as I’m concerned.
There have been a scattering articles in the NYT, WSJ, LAT, WP, etc. - almost all, in response to individual cases. There have also been editorials in these papers - perhaps one each! And you know about the two NEJM editorials. Beyond that - especially TV - almost zilch.
Where is O’Reilly when we need him? (Did I say that?)
Justice in MI
Addendum: Michigan does still have a “bribery” exception, but you would also have to prove that the drug would not have been approved without the bribe. FDA has said (rightly, in my view) that there is no office anywhere that could determine what FDA “would have done” in any hypothetical situation. So even the bribery exception is essentially meaningless.
Also, for clarification, Michigan is the _only_ state with a full preemption shield. (We take no pride in that status!) Other states have limited preemption - on punitive damages, “rebuttable presumption,” that sort of thing. We in Michigan would be very happy to have the rights that the rest of the “handful” have.
Jack2
Thanks for the update JIM.
Here’s my take on what I would like, and I think most people would agree with this:
1. I don’t want pharmaceutical companies to waste resources defending themselves from “frivolous” lawsuits. A term that’s impossible to define, which therefore makes it impossible to quantify the resources spent in this area. I won’t name names but I think we’ve seen a bunch mentioned on this site, and I also suspect for each one mentioned here there’s a bunch more we don’t hear about.
2. I don’t want pharmaceutical companies to proactively list everything under the sun in the prescribing information to head off a lawsuit. The things are already unwieldy (although the recent change in format improves them), and I’d like to keep them from getting any worse. Depending on the severity, side effects that lack a conclusive linkage to the drug belong in the medical literature – not the PI. Your cars user manual doesn’t include everything anyone ever learned about your car, and that’s why the manual’s eminently readable (if you don’t believe me go read the manual that came with your car – it’s an easy read).
3. Pharmaceutical companies cannot anticipate every possible safety problem in advance, and not all relevant safety data can reasonably be gained from a clinical trial. If a company does everything reasonably possible to not hide safety data, and acts responsibly when learning about new data, they shouldn’t be liable for unexpected adverse events (see Chantix - although I personally still doubt there’s anything wrong with that drug).
4. I don’t want pharmaceutical companies to falsify data or deliberately hide safety information (see allegedly Paxil). I may work for them, but A) I don’t want to work for a company that does that and B) I have family and friends who take these meds. Companies that do that should not be protected by preemption, and we should interpret that as fraud.
I see your point, that under current law the fraud exception is irrelevant because it has never been enforced. If the legislation were altered to include viable fraud exclusions, would that change affect your opinion?
Ellen Liversidge
Dear Judge Weinstein, I appreciate your blast at Lilly and the FDA, partners in the murder of my son. Though in reading your statement, I simply do not understand how taking the life of a 39 year old man by Zyprexa - after assuring there was no warning on the label or by the doctor; hiding the lethal side effects that caused the profound hyperglycemia that killed him, does not constitute cause for a criminal trial. Similarly, I do not understand how the FDA, which clearly knew of the side effects (both Japan and the UK had required Lilly to place black box warnings on the drug in their countries before my son’s life was taken) can escape any sort of penalty at all for not acting. The only reason they ultimately acted, in 2004, was - best I can tell - based on the three front page stories we were able to get in the Baltimore Sun, Wall Street Journal, and NY Times. And even that warning was not a black box warning…not until 2005 did a black box warning appear against off label use for dementia, and not until 2007 did Lilly finally admit the drug caused diabetes. Both the company and the government are complicit but the drug makers should have a criminal trial and go to jail. Now that you declare this as unlikely, where is the justice for the death of my only son? Lilly giving money back to states, or giving paltry settlements to the families of victims, is not justice. Perhaps there ultimately is no justice in this industry. It is hard to conclude otherwise.
I have spoken publically numerous times before the FDA, on France2 TV, and in various newspapers, but the sum total of these and other efforts has been naught. I do not understand your conclusion, Judge Weinstein, and if it stands I will never understand it, nor will my friends whose only sons were also killed by this drug.
Just A Thought
“Pharmaceutical companies cannot anticipate every possible safety problem in advance, and not all relevant safety data can reasonably be gained from a clinical trial.”
This is probably partially true but it is not the full story. There are trials and then there are trials. Some trials are based on one dose studies on healthy people. What that MIGHT prove is the AUC on average. What it MIGHT prove are variables based on individual metabolisms (are those numbers required on an application or just the averages?). What it does not prove is a long term effect. If the drug companies wanted to show the long term effect they most certainly could run a longer trial on a group that is more likely to use the medication on the long term, if that is how the drug is intended to be used. Instead they appear to punt and send it to market and see how many people get sick. Then, in my personal experience, they deny any possibility of the the illness being related to their drug.
Based on what? A few healthy folks not getting sick from one pill? Please. If that is the drug company’s best effort then everyone better start complaining. I want to know EXACTLY what I am ingesting and any possible benefits or dangers. ANY! It is my body whether the drug companies think I have half a brain or not. I want to make fully informed decisions for myself. There is no way I’m going to leave those decisions to someone with a financial interest who believes that a one dose study on someone with no medical problems is a good basis for how their drug will act in my system. Call me crazy.
Jack2
JAT: I can’t give you a percentage, but in my humble opinion, I’d say most short-term double-blind trials that test drugs which could be used chronically roll willing patients into an open-label extension study which primarily focuses on safety.
Furthermore, if a company with indication 1 pursues indication 2, doesn’t get indication 2, and notices new safety data while pursuing indication 2 then that safety data goes into the label even though the company cannot put the efficacy data in the label.
Finally, if you really want ALL the safety information then type the generic name of any older off-patent medication into pubmed (http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed). It can get overwhelming.
Justice in MI
Jack 2 - Brief response (unusual for me…). I agree with most of your points, certainly their core.
There is an interesting article by Catherine Sharkey that was linked at the Drug and Device Law Blog yesterday. Sharkey is etching out a position re: preemption that I think may transcend the special interests on all sides of the issue.
I will need more details to make that call, but the gist of it is that if a particular risk has been adequately reviewed by FDA (which, of course, assumes they had appropriate data to do so) then preemption should cover. Lots of definitional issues, of course - what constitutes an adequate review, etc. But, in principle, I think this may be a way to balance claims and preserve justice that we have not seen before.
Needless to say, fraud would, indeed, not make adequate review possible. In my view, there may also be a range of lesser delinquencies - particularly if they cluster in a constellation of, say, misleading marketing to docs - that would also negate adequate review (of those marketing materials). So lots to clarify.
That said, this may be at least the way to a solution.
whatever
And what about the people who’s found Zyprexa to be a life saver?
Are we to be denied it now?
Dianne
Hi to all. I’m very glad to see FDA preemption being discussed. Nathan, you wondered why “the mainstream press is utterly silent…” I wonder that too, and it concerns me. I live in Michigan where the predecessor to FDA preemption was born. That was 13 years ago. Media coverage of the law has been very limited. In 2006, WXYZ TV aired an excellent story re: the law. Some press, too, but that’s about it. Most Michiganders have no idea they lost their civil right to legal redress.
FDA preemption gives cart blanc immunity to an entire industry at the expense of all Americans. The New England Journal of Medicine (NEJM) called FDA preemption “A disaster for patients’ rights, public safety, and industry accountability.”
I hope, for all of us, this issue gets the publicity it needs and deserves.
Justice in MI
To whatever - Has anyone suggested that Zyprexa be withdrawn? Perhaps I missed that in the thread, but I certainly haven’t heard it more generally. And it is certainly not what Judge W. has suggested.
Rather, the issues have been about accurate reporting of risks and benefits, especially in promotional material.
Do you see the suggestion to withdraw Zyprexa somewhere?
Justice in MI
And a late night Michigan thought …
When our then Governor Engler supported Michigan’s preemption law in 1995, his aides stated directly that it was intended to “be a favor to the Upjohn Company.” Remember them?
And then the bigger Pfish ate the smaller Pfish until the biggest Pfish ate them all. And swam away, favors notwithstanding.
And so we are left with this legacy after all these years. We know un-favors when we see them.
Melody
whatever-
So you think you may be denied your “lifeline”? You NEED Zyprexa? it worked for you as no other drug did? your life will be miserable without it? SO-o-o-o-?
Corporations are allowed to make any “business decision” they want. Eli Lilly made a decision to withdraw all natural animal-sourced insulins DESPITE their own acknowledgement that some patients COULD NOT TOLERATE (survive on) synthetic insulin, genetically-engineered from E. coli bacteria. Corporations and their bean-counters merely see such individuals as collateral damage . . . there ARE no morality or ethical issues involved when “making a profit” and successfully driving a ‘business model.’ Let me say–welcome to the club, from another ‘expendable’ consumer.
Dianne
JIM: Too bad they didn’t eat the bottom feeders also.
Justice in MI
Melody/Whatever - I also “lost” a drug on which I relied. (The “external relations” person actually said this to me directly: “Don’t take it personally. It’s just a business decision.”)
Still, as far as I know, there are no plans with withdraw Zyprexa. Indeed, we will probably see Zyprexa XL, XR, etc.
Melody
JIM–
The quote from Eli Lilly’s Loren Grossman,M.D., testifying before a Health Canada commission, was this: “We know that some diabetics [no percentage given] cannot use [rDNA] human insulin.”
Lilly’s succeeding actions were to withdraw EVERY natural (animal) insulin from the U.S. market–’just a business decision.’ What does that tell you about Lilly’s concern for those diabetics ‘who cannot use human insulin’? My interpretation (except for the small window of opportunity provided by the FDA for personal importation) is “use OUR human insulin and die” or “use no insulin and die”–what a choice! I expect the Colonel, who founded Eli Lilly, as well as Banting & Best–who GAVE their discovery (insulin) to mankind–would be astounded at such compassion.
Justice in MI
Jack2 - If you happen to see this, a belated response to one bit of your post above.
As you say, “frivolous” lawsuit is hard to define. I’d like to suggest (knowing it is futile in the scheme of thing) that we don’t use the phrase at all. It is obnoxious and dismissive without having any explicit principle behind it.
Instead, I would prefer a phrase like “exploitative lawsuit,” which is really closer to what we’re talking about, and a more authentic condemnation. (Just as we wouldn’t say “frivolous fraud.”) A truly exploitative lawsuit ought to be condemned, not simply dismissed as “frivolous.” There is actually nothing “frivolous” about it.
Using such phrases may also helpbreak the knee-jerk responses to these issues as policy so they can be looked at seriously. So, at least, I’d hope!
Lauren
All I can say it is about time — it is nothing new — the only difference here is they got caught and it went to a court of law. The blame game? Please!!!
Defending Clinical Care
Ellen Liversidge: Are you affiliated or assisted by the Church of Scientology?
Ellen Liversidge
No, I am a member of the board of the Alliance for Human Research Protection. Why do you ask? Do you think that every grieving parent whose child was killed by a drug and who chooses to fight for justice is involved in Scientology? How naive of you. Some suffering parents choose to fight while others choose to nurse their broken hearts in the shadows.