March « 2009 « Medical Detox Programs in a stress-free environment

March 31, 2009

AstraZeneca Tries The Race Card In Defense Of Seroquel And Diabetes

Filed under: Big Pharma, Zyprexa, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 1:34 pm

Lawyers argue that factors including African-American ethnicity elevated the risk of diabetes before a plaintiff took Seroquel.

With over 15,000 complaints now pending, and AstraZeneca’s determination to try each case on individual merits, Seroquel liability could become the longest, and perhaps the most expensive, legal odyssey in Big Pharma’s legal liability history.

AstraZeneca “is tossing everything it has at legal cases claiming the company’s drug gave people who took it diabetes,” says blogger Philip Dawdy at Furious Seasons, including ‘the race card’. Dawdy, who says he has personally experienced the negative effects of the antipsychotic Seroquel, has a moral and an emotional stake in the outcome, if not financial.

AZ’s lawyers are claiming that ethnicity caused diabetes in Kansas plaintiff Nina Scaife, not Seroquel. They claim that factors including her obesity and being African-American already elevated her risk of diabetes before she took Seroquel.

“I can’t see how the plaintiffs can win,” gloated Michael Kelly, a Wilmington-based partner in the law firm McCarter & English, who’s slated to try the Scaife case for AstraZeneca in late June.

If AZ plays the race card in court, even one black juror could make it interesting indeed.

And you also can’t ignore the 15,000 claims (and counting), who include many who are neither black nor obese, but who got fat and got diabetes after relatively short periods of Seroquel use.

Eli Lilly fought similar claims involving the antipsychotic Zyprexa, and early on claimed that mental illness caused diabetes, not the drug. That strategy failed, and eventually the company settled Zyprexa cases totaling nearly $1.3 billion, involving numerous states, the feds, and some 28,500 individuals.

And Merck tried to block its first big Vioxx case by claiming patient Robert Ernst died while using Vioxx because he already had some degree of arterial disease. We all know what later transpired regarding the painkiller Vioxx — $4.85 billion in settlements, and the drug gone forever from the marketplace.

The real point of any such case was summed up recently by one of Scaife’s lawyers, who said that anyone with any degree of increased risk, whether diagnosed or not, needs even more protection from a drug’s side effects.

If being African American — or any other risk factor — raises the risk of getting diabetes from a drug, the drug company should ensure there are huge warnings in every communication to prescribing physicians and patients, clearly outlining these increased risk factors.

But in fact, AZ buried not one, not two, but nearly half a dozen studies that clearly showed Seroquel presented risks for serious weight gain, and possibly diabetes — regardless of racial or other predisposing factors.

Internal AZ memos reveal that company officials openly discussed and willfully decided to hide, from regulators and from the public, negative findings. Other memos discuss how the positive studies that were released were based on questionable science.

The $billions that AZ has ripped off from the states and federal government, and from tens of thousands of individuals, by selling a drug that causes chronic illness, makes the Bernie Madoff ponzi scheme look like a church bake sale.

And it’s not just the money. These officials carelessly consigned unknown numbers of people to debilitating disease and possible death without a thought of anything but profit.

Such conduct in any other setting is a criminal act. Responsible individuals are charged with fraud, fined, and locked up in jail. If his plea goes through in its present form, Bernie Madoff will be in jail for the rest of his life. And that’s just for a money crime.

Callous disregard for human life and safety is something else again. It’s met with charges of assault, or in the case of death, with manslaughter charges. But with AZ, and other similar Big Pharma cases, the charges should be murder — because they are knowing, and premeditated. And on a colossal scale.

Yet all we ever see with these Big Pharma cases, regardless of how many people are permanently injured or even killed, are fines and cash settlements.

AZ has said it will fight all the Seroquel cases. Some reports say the company has already racked up $500 million in legal bills. But since Seroquel represents close to $4.5 billion a year to the company, I suppose they can afford it.

Meanwhile, AZ wants the FDA to extend approval for Seroquel XR, the extended release version, to cover anxiety and major depression. This would add to the bipolar disorder and schizophrenia currently approved for Seroquel.

Oh right, let’s get tens of thousands more people fat and diabetic. What’s a few thousand more diseased and dying people when the $billions are rolling in? And the lame-brains at the FDA may actually go for it.

One more interesting fact. Nina Scaife was reportedly taking Seroquel for insomnia. Doesn’t insomnia sound a little distant from bipolar disorder and schizophrenia? How could any doctor, especially a family GP, possibly come up with the idea to prescribe a powerful antipsychotic for insomnia? Could the doctor possibly have gotten such an idea from AstraZeneca?

Oh heavens no. Pharmaceutical companies are legally prevented from promoting off-label drug use. It’s a crime to do so. Only doctors can prescribe off-label.

On the other hand, though, in true Big Pharma tradition, AZ apparently doesn’t mind making lots of people sick or dead. So would they shy away from “hinting” that Seroquel is dandy for simple sleep disorders too? It wouldn’t be the first time. Plenty of other Big Pharma players have been caught with their pants down after promoting off-label drug uses to physicians.

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March 27, 2009

After 30 Years Staten Island Man Wins $22.5M In Polio Vaccine Case

Filed under: Big Pharma, pharmaceuticals — Rod Malcolm @ 9:11 am

The New York Daily News reports that a Staten Island man stricken with polio after changing his daughter’s diaper 30 years ago has won a $22.5-million judgment from Lederle Laboratories, maker of the live-virus oral vaccine Orimune alleged to have passed through her stool.

The jury determined that the vaccine received by Dominick Tenuto’s infant daughter Diana was “unreasonably dangerous”, and that Lederle was “100% liable” for his injuries. The jury also found that the company failed to warn doctors of the vaccine’s risks.

Tenuto, 61, who fell ill while working at a small Wall Street securities firm in 1979, told the Daily News he lost his job, and sued two years after contracting polio. “It was a long legal fight and we finally prevailed. We waited 30 years,” Tenuto said. The award is believed to be among the highest ever on Staten Island.

“When I found myself paralyzed, a co-worker of mine called the hospital,” Tenuto said. “Little did I know that I would be paralyzed for the rest of my life.”

Tenuto, who requires a wheelchair to get around, said he spent months on a respirator in intensive care “thinking I was going to be a vegetable. I was on death’s door. We called a priest.”

His health improved after months of rehabilitation but he remained partially paralyzed. Tenuto said he tried to go back to work, but his office building wasn’t wheelchair accessible. Tenuto, who now has two infant grandchildren, said he plans to donate some of the award money to charity and some to have his teeth fixed and move out of subsidized housing.

The original Salk polio vaccine used dead viruses, and was administered by injection. Live-virus vaccines were developed later, and were administered orally. Both types of vaccine have been used around the world for nearly 60 years.

A Wikipedia article on polio vaccines says that a major concern about the oral live-virus polio vaccine is its known ability to revert to a form that can achieve neurological infection and cause paralysis. Clinical disease, including paralysis, caused by vaccine-derived poliovirus is indistinguishable from that caused by wild polioviruses. This is believed to be a rare event, but outbreaks of vaccine-associated paralytic poliomyelitis have been reported.

A 2006 study found that the rate of vaccine-associated paralytic poliomyelitis varies by region, but is generally about 1 case per 750,000 vaccine recipients. And a 2002 study says infection from the oral vaccine is more likely to occur in adults than in children. And another found that people who themselves have received the injection type of vaccination, which uses dead viruses, are more likely to be infected by exposure to the oral live-virus type.

The oral vaccine was discontinued in the U.S. in 2000, and in the U.K. in 2004, but continues to be used around the world. However, in recent years outbreaks of polio in more than a dozen countries have been attributed to the oral live-virus vaccine.

Lederle Laboratories says it is planning to appeal the decision.

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March 25, 2009

Bogus Research Reveals Serious Peer Review and Disclosure Problems

Filed under: Big Pharma, pharmaceutical giants, pharmaceutical sales — Rod Malcolm @ 8:21 am

After a Massachusetts physician had at least 21 fake studies published, serious questions arise about the credibility of peer review at respectable journals, and highlights what can happen when journals don’t ask for (or publish) researchers’ financial ties to pharma or device companies who benefit from the research.

In a recent Alison Bass blog, the author and drug approvals critic laments the disturbing situation brought to light last month when it was revealed that Dr. Scott S. Reuben, a Massachusetts anesthesiologist, had fabricated data in at least 21 studies that were accepted and published in a variety of professional journals.

Baystate Medical Center in Springfield, one of the institutions Reuben was associated with, uncovered the doctor’s fraud after a routine audit of research summaries. Reuben had failed to obtain approval of the hospital’s institutional review board for two of his newer studies.

“What ensued,” Anesthesiology News reported, “was the unraveling of what medical ethicists are calling one of the largest instances of research fraud ever reported, a massive scandal that has led to the withdrawal of as many as 21 journal articles.”

According to Bass, many of the fabricated studies were positive about painkillers like Vioxx, Celebrex, Bextra and OxyContin, two of which have since been withdrawn because of their dangerous side effects (an increased risk of heart failure). Also tainted, she says, was a study showing the value of Wyeth’s antidepressant Effexor in reducing pain among mastectomy patients.

Bass says that Reuben may or may not have been getting money from Wyeth, but according to The Boston Globe, he was a long-time member of Pfizer’s speaker bureau.

“That means he was getting speaking fees from the drug company that makes Celebrex and Bextra at the very same time he was reporting positive findings about the drugs.” Bass writes. “Yet none of these conflicts of interest were disclosed in the journal articles he published about these controversial painkillers.”

We have to agree with Bass that this represents an “egregious oversight” on the part of the professional journals, such as Anesthesia and Analgesia and the Journal of Pain and Symptom Management, which published his phony research with no mention of his financial ties to Big Pharma.

“The fact that Reuben’s results did not raise red flags at these journals says as much about the inadequacy of their peer-review process as it does about their shoddy disclosure policies around conflicts of interest,” Bass writes.

Bass also pooh-poohs the claim by Baystate officials that no one was harmed as a result of the bogus research.

“That’s a ridiculous assertion,” she writes. “Based on research done by Reuben and others, many patients were given drugs like Vioxx, Celebrex and Bextra, all of which have serious side effects, and they may well have been harmed as a result.”

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March 24, 2009

FDA Approvals Still Swing To The Tune Of Corporate Influence

Filed under: Big Pharma, FDA, pharmaceutical giants, pharmaceuticals — Rod Malcolm @ 9:54 am

The nature of the FDA’s approval process needs some serious attention by the new administration to free it from the clutches of corporate interests.

A terrific article in the Wall Street Journal amply illustrates our long-standing criticism that Big Pharma and the medical device industry have a strangle-hold on at least some of the science that should drive all of the Food and Drug Administration’s approvals processes.

A new device from ReGen Biologics Inc. to treat common knee injuries, called Menaflex, received approval last December under the agency’s fast-track approval rules, in spite of the fact that it had already received repeated rejections by FDA scientists.

The FDA’s significant internal scientific dissent over Menaflex was overwhelmed, reports the Journal, by a massive lobbying campaign by Regen BioLogics. The Journal says internal documents reveal that senior FDA staff members complained that the handling of Menaflex shows how political and industry pressure can influence scientific conclusions.

At issue isn’t the efficacy of the device, says the Journal — that remains in dispute — but the nature of the FDA’s own approval process. The objecting scientists had problems with the device, and with the decision to fast-track it. And even former Commissioner Andrew von Eschenbach, who was head of the FDA in December when Menaflex was approved, said, “We fumbled that process.”

Dr. von Eschenbach, who stepped down in January with the arrival of the new administration, is calling for an overhaul of the way the $200 billion-a-year medical-devices business is regulated, says the Journal. The fast-track system “has gotten out of control,” he said.

Menaflex was approved under rules requiring no clinical trials because it is similar to existing products. However, there are no other devices like Menaflex on the market. Jay Mabrey, chief of orthopedic surgery at Baylor University Medical Center in Dallas and chairman of the FDA advisory committee that considered Menaflex, says for this reason the FDA’s decision to approve was wrong.

In January, reports the Journal, a group of nine FDA staff scientists in the device division wrote to Congress, and to the Obama transition team, calling on the president to remove top FDA medical-device regulators. The device-approval process has been “corrupted and distorted by current FDA managers,” the letter says. The letter’s authors haven’t been publicly identified.

But Dr. Mabrey also says, “In retrospect, I think they were stacking the committee to get the decision the company wanted.”

We usually blog about Big Pharma here, because of our close association with drugs, or rather, with their miserable side effects, dangers and addictiveness. But the FDA’s involvement in approving or disapproving medical devices — the gadgets used to help bodies heal from or deal with disease and injury — are of concern as well, because like drug approvals, they demonstrate the level of agency independence from corporate profiteering, and show how well the FDA does its job in protecting Americans from dangerous products.

Also, we’ve all heard that Big Pharma has become too cozy with the upper echelons as well as the rank-and-file at the FDA. The device industry is also a vital component of health care in America, part of the same scene, and potentially just as dangerous as drugs.

The FDA is supposed to be our agent, our personal bodyguard protecting us from dangerous, ineffective drugs and devices. The Menaflex story shows us once again that when big money talks, the FDA walks. I hope President Obama’s new FDA executives take a good long look at this story, and act accordingly by removing the corruptions that exist in the agency’s approvals process.

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March 20, 2009

More On AstraZenaca’s Very Unscientific Seroquel Sex Scandal

Filed under: Big Pharma, pharmaceutical giants, pharmaceuticals — Rod Malcolm @ 8:39 am

Now we’re talking kinky bondage and corporate espionage, adding to the earlier revelations about using sex in the pursuit of favorable ‘clinical research’.

A few weeks ago we blogged about the high-level AstraZeneca research director engaging in sexual shenanigans with a Seroquel researcher and the ghost-writer hired to write the research results for publication.

Then a week later we blogged about AZ allegedly hiding Seroquel’s weight gain and diabetes side effects for nearly a decade, which has led to some 15,000-plus lawsuits alleging deaths and injuries from the drug.

Now this week, more juicy details have come to light, and the Furious Seasons blog has got them. And in spite of repeated requests from the blogger, the FDA has made no response, neither to the questions, nor taken any interest in taking a new look at the Seroquel research, which is now so obviously tainted.

Wayne MacFadden, the former U.S. medical director for Seroquel, slept with a researcher working on Seroquel trials, and with another woman working on documentation. He apparently offered Vicodin to one of them, and attempted to get confidential information about Bristol-Myers Squibb’s FDA filing for a bipolar depression approval for rival drug Abilify from the other.

Extracts from court depositions of McFadden by the lawyers representing the death and injury cases reveal maybe a little bondage or S&M may have been involved. The confessions include descriptions of sex in hotel rooms paid for by AZ, illicit distribution of Vicodin, and a kinky relationship in which one of the women asked to be “punished” for looking at a study that had negative results for Seroquel. To which MacFadden replied: “You will be punished (in the usual fashion!) when I see you … but perhaps more harshly this time!!!”.

Says Furious Seasons: “McFadden used sex (and bondage even) to get competitive intell on Abilify and, yes indeed, even suggested prescribing Vicodin, a narcotic pain killer, to a ghostwriter with Parexel MMS. I simply love how Big Pharma does business and I love the fact that the FDA continues to blow off my questions as to whether it has any qualms about its approval of Seroquel for bipolar depression (in 2006) since Macfadden was in charge of the studies, authored some of them, and clearly was putting out questionable research. You’d think the FDA would want to give it all a little look-see, but no. The FDA doesn’t care.”

The transcripts have been edited “to hide the identities of the women involved, but other documents in the case, says Jim Edwards at BNET.com, indicate that many of MacFadden’s colleagues had figured out that he was cheating on his wife with his work acquaintances.”

Comments on various blogs following the story, some apparently by industry insiders, suggest that this is all just business as usual in the halls of Big Pharma. One suggests that everyone should diligently avoid pharmaceuticals and physicians, and instead investigate alternative therapies whenever possible.

Not a bad idea.

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March 19, 2009

Schering-Plough Proposes $165 Million Shareholder Settlement

Filed under: FDA, Merck, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 10:36 am

The company already paid a $500 million fine for uncorrected manufacturing problems, but admits no liability or wrong-doing. Meanwhile, the Schering-Merck merger moves forward.

Schering-Plough Corp. has proposed to settle a securities class-action lawsuit alleging the company defrauded its investors by failing to disclose manufacturing defects that delayed FDA approval of the allergy drug Clarinex for more than a year.

The investor suit accuses the drug maker of not disclosing quality-control defects at four plants, brought to light by an FDA investigation. The investors sued after the company finally revealed that the FDA was withholding approval of Clarinex until the company fixed the manufacturing problems. Clarinex was the successor to Claritin, SPC’s top-selling drug at the time.

According to Bloomberg News, U.S. District Judge Katharine S. Hayden will consider the proposed settlement at a hearing on June 1 in Newark, New Jersey. If accepted, the $165 million will go into a fund for investors who purchased securities between May 9, 2000, and Feb. 15, 2001, the day the company warned that manufacturing problems would hurt earnings.

The company says it is admitting no liability or wrongdoing, and has agreed to settle the case to avoid protracted and expensive litigation. The settlement will close all claims asserted against the company in the lawsuit, and is covered by insurance and existing reserves, the company said.

The FDA had warned the company it needed to improve the safety and oversight of its manufacturing plants, and delayed its approval of Clarinex for nearly a year. The company paid a $500 million fine for the manufacturing problems despite the agency’s warnings.

Also this week, Merck & Co. has agreed to buy Schering-Plough for $41 billion, yet another in a series of pharmaceutical company mergers aimed at money saving diversifications. On the lighter side, various amusing names for the new merged company are already being bandied about in the Big Pharma-watcher blogosphere.

A couple of excellent names, proposed on the Schering-Plough watchdog blog ShearlingsGotPloughed, should be read for their sound-alikes: Schirck, and Schmerck.

Need we say more?

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March 17, 2009

White House Choice For FDA Commissioners Reportedly Set

Filed under: FDA — Rod Malcolm @ 8:42 am

Obama administration choices are a perfect fit for the stated aims of a reinvigorated FDA role in public health, and a hopeful sign of better things to come.

According to the Wall Street Journal, the Obama administration has settled on two public-health experts to fill top posts at the Food and Drug Administration.

Margaret Hamburg, a former health commissioner in New York City, is said to be the leading candidate for FDA commissioner. Baltimore’s public health department chief, Joshua Sharfstein, will likely be named a deputy commissioner.

These two choices appear to perfectly match the new administration’s aim to guide the FDA “back to its core mission of public health”, the Journal reported this week, and avoid any congressional debate over whether the choices are perceived as pro- or anti-industry because neither candidate is seen as strongly one way or the other.

FDA watchers have been waiting for months for the new White House to make some kind of definitive move, while almost all other major federal agencies received nominees to replace out-going Bush administration appointees.

“Behind the scenes,” says the Journal, “pharmaceutical companies and industry-supported patient groups have rallied behind various candidates seen as more favorable to industry concerns, while consumer advocates have openly lobbied for their own choices.”

Dr. Margaret Hamburg, known to most as “Peggy”, is 54 years old, and was one of the youngest New York City health commissioners during the time of the first World Trade Center bombing in 1993, won support for a clean-needle-exchange program for drug addicts to limit the spread of AIDS, and opposed the “morality oath” demanded by the Board of Education in 1992 while the city debated abstinence-focused sex education. She said science-driven public-health practices, not “moral judgment” or “wishful thinking,” should be the basis for AIDS education in schools.

She was an assistant secretary of health and human services during the Clinton administration, and more recently has worked at the Nuclear Threat Initiative, a think tank run by former Democratic Sen. Sam Nunn. She is now a leading advocate for changes in the nation’s public health policies and infrastructure, from local health departments to the highest levels of government, to meet the challenges presented by modern bioterrorism. She is a distinguished senior fellow with the Center for Strategic and International Studies, and also serves on the board of Henry Schein Inc., a medical-equipment wholesaler.

You can read more in this brief biography of Dr. Hamburg at the National Institutes of Health web site.

Dr. Joshua Sharfstein, 39, was a favorite candidate for the top job among many consumer health and safety groups, but drew strong opposition from the drug industry. Sharfstein became known as an outspoken public health official who kept a sharp eye out for drug industry improprieties, alerting medical journals to Big Pharma gifts-parties-and-booze events that violate the American Medical Association’s council on ethical and judicial affairs, saying it is unethical for doctors to attend such events. Dr. Sharfstein also published damning, long-overdue data on over-the-counter pediatric drugs, detailing not only the massive market for such drugs, but their general ineffectiveness and potential for harm.

Imagine! A public health doctor actually looking out for public health! Can’t have that, can we! These were the kinds of actions on behalf of public health that led Big Pharma’s lobbyists to push Republicans to oppose Dr. Sharfstein for the top commissioner job.

Fortunately, deputy commissioners don’t require Senate debate and approval, so Dr. Sharfstein can walk into that post unopposed, and the FDA will be better for his presence.

Meanwhile, Big Pharma can’t find anything much to oppose in Dr. Hamburg. And her record on behalf of public health and welfare is spotless.

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March 10, 2009

New Study Confirms Placebo Effect In Teen Depression Trials

Filed under: Big Pharma, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 10:37 am

More evidence supports earlier findings that antidepressants are at best marginally better than a placebo, and worse if one considers their known risks.

Teens diagnosed with moderate to severe depression and treated with placebo “achieve outcomes similar to those of patients who received active interventions, despite having received less treatment overall than those initially treated with an active intervention”, says a new study just published in the American Journal of Psychiatry.

The study evaluated placebo treatment from the standpoints of ethical acceptability, risk of harm from withholding active treatment, and use of “rescue procedures” to minimize negative consequences.

The study involved 439 adolescents with major depressive disorder, randomly assigned to receive an initial 12 weeks of treatment with Prozac (fluoxetine), cognitive-behavioral therapy (CBT), a combination treatment with Prozac and CBT, or clinical management with placebo. Kids on placebo received open active treatment as clinically indicated after 12 weeks of placebo. Assessments were conducted every 6 weeks for 36 weeks.

“At week 36, the response rate was 82% in the placebo/open group and 83% in the active treatment groups,” the study found.

The remission rate was 48% in the placebo/open group and 59% in the active treatment groups, a difference that approached statistical significance. Patients who responded to placebo generally retained their response.”

The study’s findings that patients treated with placebo are not harmed, and that placebo is an acceptable intervention in randomized controlled trials with adolescents who have moderate to severe depression, is, I’m sure, interesting to researchers.

But the findings that any suicide attempts among placebo patients happened AFTER the kids were on “active treatment” later in the trial — I believe that means on Prozac — is of a lot more interest to me. And if you care anything about your fellow human beings, it should also be of great interest to you.

This is yet another in a series of studies that show placebos are statistically on a par with dangerous psych drugs among teenagers. We’ve known for decades that Prozac causes suicidality, especially among the young — and I’ve never heard about any suicides caused by a sugar pill. And the flip side of depression — aggression and violence — are also among the side effects of antidepressants.

These drugs should play no part in the lives of children for ANY reason, including whatever “moderate to severe depression” means this week. The antidepressants-for-kids brigade has really run out of ammunition after this study, and they should all just go home and be quiet.

If this doesn’t seem to matter to you, first think “teen suicides” and “school shootings”, and then give this whole affair a little more thought.

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March 5, 2009

U.S. Supreme Court Rejects Preemption, Upholds Wyeth vs. Levine

Filed under: Big Pharma, FDA, pharmaceutical giants, pharmaceuticals — Rod Malcolm @ 2:14 pm

In a 6-3 decision, the court ruled that federal law does not preempt a lawsuit in state court, maintaining that people can hold drug companies financially responsible for injuries. Roberts, Scalia and Alito dissent.

Rejecting the Bush administration’s position undermining state tort law, the Supreme Court has affirmed a Vermont jury’s $6.7 million award to Diana Levine, the guitarist who sued drugmaker Wyeth for the loss of her arm to gangrene following an IV-push injection of Wyeth’s anti-nausea drug Phenergan.

Levine claimed Phenergan’s label inadequately warned about potential dangers of Phenergan IV-push injections. A Vermont jury agreed, awarding $6.7 million. Wyeth appealed, arguing that the case should be thrown out because the label had been approved by the FDA, but the Vermont Supreme Court upheld the jury verdict. Wyeth then appealed to the U.S. Supreme Court.

The decision affirms historical legal precedent and practice in the country, by which state-level product liability lawsuits can be brought against drug companies, even though the company may be in compliance with federal FDA regulations.

Congress and the FDA have long held that state level actions are a valuable and even a necessary adjunct to help assure public health and safety. And the FDA, as even a cursory review of its record confirms, has never been assumed competent to assure such safety.

But recently, under the Bush administration, federal preemption of state law found solid new footing. Machiavellian regulation-tinkering across multiple departments attempted to secure a hospitable environment for federal preemption policy, leading even the FDA to publicly reverse its decades-long position in favor of state tort. In fact, FDA lawyers and officials reportedly even assisted with Wyeth’s appeal.

Wyeth vs. Levine was seen as the ‘test case’ at the Supreme Court that, if the court favored Wyeth, would drive the final nail into the state tort coffin for drug liability, just as it last year for medical devices.

Both sides emailed comments to the WSJ Health Blog:

Wyeth’s lawyer said: “We believed that Federal law prohibited the company from revising its product label as the Vermont court required, and we regret that the Supreme Court disagreed. The medical and scientific experts at FDA are in the best position to weigh the risks and benefits of a medicine and to assess how those risks and benefits should be described in the product’s label.”

Levine’s lawyer said: “The Supreme Court’s opinion reaffirms the important role state law plays in promoting consumer safety and providing compensation for injuries. More importantly, the decision permits Ms. Levine to put this chapter behind her and to move on with her life.”

If you ask me, the whole nasty affair illustrates just how wide, and how deep, corporate money, influence and greed flowed into and throughout the corrupt Bush administration.

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March 3, 2009

AZ ‘buried’ negative trial results, and praised a project physician for ‘a great smoke-and-mirrors job’ by hiding data from a ‘cursed’ trial, say unsealed internal memos.

Filed under: Big Pharma, FDA, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 2:15 pm

Lawyers suing AstraZeneca on behalf of nine thousand people alleging damages from consuming the $4.4-billion blockbuster antidepressant Seroquel say recently unsealed documents show the company hid the side effects of significant weight gain and diabetes for nearly a decade, while continuing to heavily market the drug.

According to a New York Times article this week, a 1997 e-mail from Richard Lawrence, an AstraZeneca official, praised Lisa Arventis, the company’s Seroquel project physician, for minimizing adverse findings in what he called a “cursed” study.

Says the Times, Lawrence wrote: “Lisa has done a great ‘smoke-and-mirrors job!’”

“AstraZeneca knew about the risk of weight gain and diabetes in 2000 and not only failed to warn physicians and patients but marketed [Seroquel] in a way that represented there was no risk,” Edward F. Blizzard, a Houston-based lead lawyer on the cases, said in a conference call with reporters, the Times reported.

Lawyers for both sides this week agreed to unseal 102 of 111 documents at issue in the case, a few among millions of pages of discovery material assembled for the massive suit.

In another e-mail message from 1999, reports the Times, AZ’s publications manager John Tumas wrote: “The larger issue is how do we face the outside world when they begin to criticize us for suppressing data.” He said three drug trials had been “buried.” Referring to a fourth, he said, “We must find a way to diminish the negative findings. But, in my opinion, we cannot hide them.”

This case continues to illustrate why Big Pharma now bears the label as possibly the most greed-motivated and uncaring industry in history. Recent surveys in various media show a cataclysmic loss of public confidence. And there is mounting evidence that a backlash among medical professionals will soon spell the end of any kind of cozy relationships Big Pharma once enjoyed with physicians.

Even a few psychiatrists, if you can believe it, are going public with their thoughts and opinions in scattered journal articles and blogs criticizing Big Pharma’s record of misinformation and blatant unethical marketing of not just psychiatric, but all sorts of drugs.

Psychiatrist Dr. Dan Carlat, a particularly outspoken critic of many things pharmaceutical and psychiatric, commented in The Carlat Blog on the revelations about the company’s lead research director, Wayne McFadden, reportedly having sexual relations with a company-funded researcher and a ghostwriter.

Dr. Carlat writes: “The document alleges that MacFadden’s relationships with the women were ‘relevant and highly probative evidence of one high level AstraZeneca employee’s determination to exploit his sexual relationships with these women in order to elevate Seroquel’s status in the prescribing medical community through supposedly ‘independent’ publications of Seroquel safety and efficacy data….Moreover, the mere existence of these relationships calls into question the integrity of the scientific work product of those involved.’”

Other unsealed documents show more problems for AZ sales — and stock prices: Multiple studies showed that Seroquel was not as effective as competing drugs in the same class, including Lilly’s Zyprexa.

But then, Lily is having problems of its own with Zyprexa, as we reported in a recent blog, setting record for the largest single corporate settlement in American history with criminal and civil fines and penalties totaling $1.4 billion.

And the FDA is asking AZ for more info about the safety and effectiveness of the extended release version, Seroquel XR, which the company wants to market for anxiety and major depression as well as the already approved schizophrenia and bipolar disorder.

Oh my. Just the thought of thousands more people getting talked into taking Seroquel in any form is enough to bring on a major depression. The world needs to wake up and see that psych drugs are about as safe as a bread knife in the hands of a homicidal maniac, which is why Big Pharma has been lying about them for decades in the first place.

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