Zyprexa Judge: FDA Can’t Police Safety Problems
Without lawsuits like the one the State of Alaska brought against Lilly over Zyprexa marketing, claims that drugs cause health problems “might well go unaddressed,” Anchorage Superior Court Judge Mark Rindner said from the bench this week. He made his remarks while the jury was out of the room, after the state had rested its case and Lilly asked for an immediate verdict in its favor, a routine step at that point in a trial.
As part of the proceeding, Lilly’s lawyer, George Lehner, argued that drug regulation is a matter for the FDA, not any state, and that Alaska’s Unfair Trade Practices and Consumer Protection Act shouldn’t apply to drugs. Rindner disagreed. Evidence presented by the state over the past two weeks established that the FDA “isn’t capable of policing this matter,” he told the courtroom, according to The Anchorage Daily News.
The exchange came during a closely watched trial in which Alaksa is suing Lilly to cover costs to Medicaid for treating weight gain and diabetes linked to the Zyprexa antipsychotic. The outcome - and even evidence - could influence settlement talks under way with the US Attorney in Phildelphia and state attorneys general, because an unfavorable verdict could prompt other states to file lawsuits, although nine already have.
Rindner’s remarks also focus attention on another closely watched legal battle - preemption. This concept turns on whether FDA approval of a drug supercedes state law claims challenging safety, efficacy or labeling. Drugmakers and the FDA argue preemption exists by maintaining the agency’s decisions are the final word on safety and effectiveness. The US Supreme Court will take this up in the fall.
Meanwhile, Lilly’s first witness was Silvio Inzucchi, a professor of medicine at Yale University, who is director of the Yale Diabetes Center, and internal medicine doctor who said he has treated thousands of diabetics. Under questioning by Lilly lawyer Andrew Kantra, Inzucchi testified he reviewed all the published studies on any connection between Zyprexa and diabetes. His conclusion: “Zyprexa does not cause diabetes.”
It doesn’t affect insulin resistance or production, he continued, and while weight gain increases the risk of diabetes, it doesn’t cause diabetes. Someone with a healthy pancreas who gained a lot of weight while on Zyprexa might never get diabetes, he told the court. He then added that studies found that patients may have had elevated blood sugar while on Zyprexa, but that’s not the same thing as diabetes, the Daily News reports.
Under cross-examination, however, Inzucchi acknowledged an “association between Zyprexa and diabetes” first shown in studies in the late 1990s. And look at this - In a Diabetes Fact Book that Inzucchi wrote last year, there are numerous references to the need for reducing weight. Seems a bit disingenous, no? A diabetes expert for the state previously testified that Zyprexa did cause the disease. UPDATE: As pointed out to us, Inzucchi has previously disclosed that he receives grant/research support from Lilly; consults for Merck, Novartis, Pfizer and Takeda; and is a member of the speakers bureau for Takeda.
Lilly also called David Kahn, a psychiatrist at Columbia University Medical Center and professor of psychiatry. He gave jurors a vivid view of the horrors of an extreme case of schizophrenia. Lilly’s team played a video of a psychiatrist’s interview with Russell Weston, who shot and killed two guards in the US Capitol in 1999 because he wanted to keep the country from being ruined by cannibals, the paper writes.
An early generation of anti-psychotics helped patients but had side effects like muscle tremors and jerking. Those drugs sedated them to the point they went through life with what felt like a “wet blanket over their head,” Kahn told the court. Drugs like Zyprexa were a “quantum leap forward” but also had risks, he told jurors. The first to come on the market, Clozaril, had a potentially fatal side effect: It could wipe out a patient’s white blood cells.
Kahn testified he began prescribing Zyprexa when it was approved in 1996 and he knew from colleagues involved in clinical trials that it brought a risk of weight gain, according to the News. But he told jurors that docs had many sources of info about drugs and their risks: medical journals, continuing education, package inserts, drug companies and their sales representatives, colleagues, and published guidelines.
Scott Allen, a Houston lawyer representing the state, pressed Kahn on whether he knew what Alaska doctors were told about Zyprexa. Kahn said he didn’t. Is there any source of information that Lilly is not involved in? Allen asked. No, Kahn said, according to the News.
MidwestRebel
Thumbs up to Judge Rindner: ….the FDA “isn’t capable of policing this matter”.
I’m a consumer with an aversion to paranoia and conspiracy theories, but there is no longer any doubt in my mind that much of the FDA administration is totally corrupted….with the exception of honorable scientists like Dr. David Graham. The problems go far beyond Vioxx. It has become corrupted by user fees, and more and more political (campaign contribution) interference, not to mention inteference in oversight enforcement. An agency which SHOULD be the Gold Standard for the world grows more tarnished. Even medical journals are tainted by pharma money. For example, “New England Journal of Medicine receives approximately $18 million a year from pharmaceutical companies, while JAMA, the Journal of the American Medical Association receives around $27 million.” The results of clinical trials are being manipulated or even withheld if they shed an unfavorable light on a new drug. Drugs and/or their ingredients supplied by foreign companies with little or no oversight are introduced into our pharmacies every day, but most consumers don’t know that. Our doctors are wined, dined and gifted into submission to prescribe drugs that may or may not be better, effective or even safe. Consumers pay obscene prices to be put at risk and yet aren’t usually aware that they are nothing more than paying guinea pigs for the latest ‘FDA-approved’ prescription. Television plasters us with ads ad nauseum for the latest wonder drugs from sunup to sundown; magazines, websites, nearly every source of news is overdosed with ads.
Perhaps consumers should demand that the impotent FDA be dissolved and its taxpayer-funded budgets returned to taxpayers in the form of HUGE refund.
Justice in Michigan
Re: Midwest Rebel’s comments, there is much I agree with. However, it is important to say that many of FDA’s problems can be placed squarely at the feet of Congress, both parties, over many years. They have consistently either not provided the agency relevant powers or provided them without the means - material, technical, personnel, and beyond - to carry them out.
Unquestionably there are a lot of shmoozers and courtiers among FDA senior administrators - the usual bureaucratic CYA experts. But the vast majority of FDA reviewers and line staff are as dedicated as any group, anywhere.. As others have said, the agency itself is an easy target. But going after it deflects our attention from who is most centrally responsible - the folks who work in the Capitol Building who make the budget (In one year, Lipitor earns twenty-five times CDER’s _entire_ annual budget) and the folks in the White House who decide who heads HHS and the senior positions in FDA.
Meanwhile, may the word go out from Alaska to another Court, also in our nation’s capitol. And may they friggin hear it.
Justice in Michigan
In the “you don’t need a weatherman” department, “creative” for Lilly defense to show a video of the horrors of schizophrenia. And the disease is horrific indeed.
But none of that explains how Zyprexa became one of the top ten best-selling drugs in the country, pretty close to Nexium.
Are there that many psychotic folks in the U.S.?
Justice in Michigan
Forgot to respond to this from my Midwest comrade:
“Perhaps consumers should demand that the impotent FDA be dissolved and its taxpayer-funded budgets returned to taxpayers in the form of HUGE refund.”
Guess what we’d each actually get if we divvied up the _entire_ FDA budget (of which only 1/4 is about drugs)?
Seven bucks ($7) a person. And that includes the hunk in FDA’s budget that comes from industry in users’ fees.
If you want real money, let’s divvy up NASA. We’d each get about fifty bucks plus moon rocks.
FDA oversees 25% of the U.S. economy. NASA oversees voyagers, challengers, and an occasional comet.
Conflict of interest statement
Relevant Financial Relationships
Dr Inzucchi has indicated that he receives grant/research support from Eli Lilly & Company; is a retained consultant for Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Pfizer Inc, and Takeda Pharmaceuticals North America, Inc.; and is a member of the speakers bureau for Takeda Pharmaceuticals North America, Inc.
Laurie
“Is there any source of information that Lilly is not involved in? Allen asked.
No, Kahn said. ”
A statement that speaks volumes!
Lauren
So, according to the Lilly shill that initially said Zyprexa doesn’t cause diabetes, my son could have merely been killed by profound hyperglycemia. Well, isn’t that comforting. We will never know as he had only one ONE blood glucose test.
I’ve heard all the arguments about the FDA not having enough money and blaming it on Congress, and there may be truth to this. But in my mind the ultimate culprit is George W. Bush. He has trashed every department of the Executive Branch. The muzzled scientists at the FDA have brethren in every other branch that has scientists. Every branch is wrecked. Remember FEMA? The EPA? And remember Waxman’s study that showed that in the first five years of Bush’s Reign (he believes he is a King) the FDA had issued half as many warnings to the Pharmas than in the previous few years.
Most of Junior’s years, he had a Republican Congress. Now the Dems have a slim majority. The Hill is crawling with Pharma lobbiests; I think they give the second most cash after the Chamber of Congress. The deck is stacked. The ultimate blame lies at the feet of the worst president we have ever had. One of Syd Taurel’s best pals.
Justice in Michigan
Hi Lauren - You won’t get much argument from me. I included both branches and, of course, the Judiciary is on the way. We need not decide on where most of the responsibility lies so long as we are prepared to take on all those we deem play a part. This is an election year, so there are a lot of folks who could be held accountable.
Lauren
The first, and only, demonstration I attended, in 2005, was in Lafayette Park and on the sidewalk in front of the White House. Of course, Jr. wasn’t there, but we were buzzed by police cars and motorcycles the whole time. Secret Service were up on the roof of the WH. I met some wonderful people who remain connected to me. Bush was the focus of our anger. Many of us had lost family members.
But your point is well taken. There is complicity enough to go around to every part of government. It is this way with all large corporations. The problem with Pharma is that they don’t sell sneakers; they sell lethal products and don’t bat an eye if people are killed due to their myriad of dirty tricks.
Justice in Michigan
My first was in 1967, same park, different war.
You may disagree some here as well, but pharma is not a monolith. There are plenty of people in the industry who are as outraged - and sometimes personally shredded - as many of us, although very rarely having suffered a loss like yours.
They are obviously not the final decision-makers in situations of the kind you describe. But they are there. If the industry doesn’t self-destruct first via preemption and similar schemes, they have a chance to recreate what was always far from perfect, but still …
Back in ‘67, in Lafayette Park, there were also those who had been there. They came back to join us.
gloria
MOTHER AND LEGAL GUARDIAN IN NYC.
Silvio E.Inzucchi, MD has no credibility in my eyes. He is tinted with “relevant financial relationships” with big pharma. He makes an extraordinary living lying about the most dangerous neurotoxins on earth. His license should be revoked…so his statements won’t contribute inflicting more damage to humanity.
A case in point:
Wilfred Postel, psychiatrist for Earth House School of Somerset, N.J., ordered on the telephone, with deprave indifference, to administer my son Albert, Olanzapine (Zyprexa) 15mg on 9.11.98, he was 19 years old then. Postel didn’t even bother to read his medical record, much less he didn’t even give him an evaluation.
This is what Loren R. Mosher MD Board Certified Psychiatrist - California License # CA14219 wrote in his Expert Opinion dated 12.4.02:
“The administration of Olanzapine prescribed by Dr. Postel and given by Earth House provided a toxic re-challenge to Mr.Levy’s already damaged neuroleptic hypersensitive brain. This exacerbated a neuro-toxic process in Mr. Levy, that resulted in further behavioral (immediate) and cognitive (longer-term) deterioration. He is now, and will likely remain, totally disabled with an IQ so low as to making testing unrealiable. He will require 24 hour 1:1 care for the rest of his life.”
Earh House Director, Greer S. Imbrie, acknowleged that the zyprexa had made Albert worse. When I took him home, he didn’t know his name or who I was and became ferociously violent, and showing extreme anxiety. He almost killed me three times and also attempted against other members of my family as well. I had to hire 3 male attendants to prevent Albert from breaking windows, walls, and from attacking me.
The psycho-pharma cartel as people call it in this medium, is so negative to a civilized society… “the Crib of Democracy” that lawyers see the opportunity to sell you out, judges dismis your case, advisers steal from you, only because they see your anguish with a psychotic child and you are desperate for survival.
We lost a $10M contract with the City of NY, we lost our real estate $5M and collateral damages $25M and first and foremost is Albert suffering because we cannot communicate with him as he doesn’t make sense and he prefers to be mute. Albert is 28 now, still exists because he has been detoxified with 7 different techniques,among them, the first one with Traditional Chinese Botanicals to cleanse the liver and the kidneys, the best…$120 is extremely effective. The second one with Essential Oils… $300, magnificent. The third one Doctor’s Choice Cellular Detox… $300, extraaordinary. And any other detox sold on TV and in health food stores. They all work miracles. But most be taken under secure environment because the person can become overwhelm with extreme anxiety. You need your family with you.
I suffered too much for 5 years with Albert totally psychotic running in the streets of Manhattan, while Honorable Jack M.Sabatino JSC - Superior Court of NJ - Mercer County Court House, ordered Albert’s attorney AAron David Frishberg to settle, otherwise he would dismis the case, which he did because the $15,000 offer of Stahl & DeLaurentis, PC attorney for Postel…was unacceptable. That’s the amount Frishberg received from me to represent Albert.
Our family has spent $500,000 caring for Albert during the lapse of 13 years…about $40,000/year. Medicaid is paying $247,000 per bed on average to psychiatric wards. This means my family has saved the government $4M. Albert, because his ‘0′ IQ, incontinence and severe cognitive impairment, his care will cost much more about $300,000/year including his rehabilitation and entertainment long overdue…our goal is to get him out of his chronic dementia.
Zyprexa is so dangerous, that just 15mg wiped out ‘64 IQ’
NY Hospital and Metropolitan Hospital in NYC - iatrogenic treatment - had left Albert with. The entire neuroleptic fiasco is so criminal it calls for the elimination of these medicines like a plague, we need detoxification clinics in abundance, and healing places in the mountains and the states will save billions.
I hold Ely Lilly responsible for the tragedy brought upon us, and for the almost destruction of my entire family. We demand a compensation suitable to our loses.
Thank you for the opportunity to ventilate our horror story.
Justice in Michigan
On the general topic of detailing, Dr. Sal has a good letter in the New York Times today…
Prescription Access Litigation (PAL) Project » Blog Archive » Why Drug Lawsuits are Necessary: FDA “isn’t capable of policing” drug safety, says Alaska Judge
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Grieving
So Gloria, you lost your son, too. If you wish, I am sure you can get my email privately from Ed. I would like to communicate with you. Even though my son was killed and yours was not, the common thread of Zyprexa makes us share the worst of all worlds. I am sorry to hear your story.
Simon Passanante - Lilly to pay $15 million to settle Alaska’s Zyprexa suit
[...] Pharmalot and the Anchorage Daily News reported earlier that after the state rested its case, and while the [...]