Vioxx « Medical Detox Programs in a stress-free environment

April 28, 2009

Court Discloses More Proof That Merck Knew Vioxx Was Risky

Filed under: Big Pharma, Vioxx, pharmaceutical giants, pharmaceutical sales — Rod Malcolm @ 8:31 am

In an internal email from 2001, a critical senior Merck researcher says interpretation of Vioxx test data was “wishful thinking . . .interpreted to support a preconceived hypothesis.”

Merck paid a cardiologist to sign his name to a 2001 medical journal article written by Merck staff that claimed no evidence of cardiovascular events arising from its painkiller Vioxx, according to court records in an on-going Australian class-action suit.

The class action alleges Merck covered up a higher risk of cardiovascular conditions.

More than 1000 complainants cite cardiovascular conditions following at least one prescription of the drug.

The Sydney Morning Herald reports that a 2001 email submitted in court shows that senior Merck researcher Briggs Morrison “expressed concern about the claim that Vioxx was not associated with an increased risk of cardiovascular events.”

“That seems wishful thinking, not a critical interpretation of the data,” Dr. Morrison said in the email to colleagues. “The data appears to have been interpreted to support a pre-conceived hypothesis.”

But the claim of no risk was nonetheless included in the final version of the article, which was sent to consulting U.S. cardiologist Dr. Marvin Konstam for approval and signature, and eventually published in the medical journal Circulation in October 2001, the Herald reports.

Dr. Konstam was named lead author, five of the authors were Merck employees, and the other two, including Dr. Konstam, were paid consultants.

If you’ve been following the Vioxx saga for the past few years, the name Briggs Morrison might ring a bell. Back in 2005 in Atlantic City, NJ, Morrison achieved notoriety of sorts when the judge in the second Vioxx trial ordered his defense testimony on behalf of Merck be stricken from the record, saying he overstepped his role as a fact witness.

Judge Higbee said at the time: “Quite frankly, I felt sick yesterday afternoon. I realized how I have got sucked into this. I feel that I was misled during the testimony.”

Higbee said Morrison, Merck’s lead-off defense witness, testified about a series of animal tests and their implications for the safety of Vioxx, but was not an expert on the subject and completely unqualified to testify.

Will it ever end? Merck’s grasping financial greed and ethical deficiencies are matched only by its stupidity.

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April 9, 2009

Email Reveals Merck’s “Hit List” Of Critical Doctors To “Neutralize”

Filed under: Merck, Vioxx — Rod Malcolm @ 10:33 am

An internal email released in an Australian federal court reveal that Merck maintained a hit list of doctors critical of Vioxx with “neutralize”, “neutralized” or “discredit” against their names. The company also threatened critical institutions with loss of funding.

An article in The Australian reports that Merck staff emailed each other about the list of doctors — mainly researchers and academics — who had been negative about the drug Vioxx or Merck and a recommended course of action.

The email came out in Federal Court in Melbourne, Australia as part of a class action against the drug company. Next to the names of doctors were the words “neutralize”, “neutralized” or “discredit”.

The email also alleged that the company used intimidation tactics against critical researchers, including “dropping hints it would stop funding to institutions and claims it interfered with academic appointments,” the article in the Australian said.

“We may need to seek them out and destroy them where they live,” a Merck employee wrote, according to an email excerpt read to the court by Julian Burnside QC, acting for the plaintiff.

Merck & Co and its Australian subsidiary, Merck, Sharpe and Dohme, are being sued for compensation by more than 1,000 Australians, who claim they suffered heart attacks or strokes as a result of taking Vioxx.

Launched in 1999, Vioxx was used by 80 million people worldwide because it did not cause stomach problems like other anti-inflammatory painkillers. It was voluntarily withdrawn from sale in 2004 after concerns were raised that it caused heart attacks and strokes. A clinical trial testing these potential side effects was aborted for safety reasons.

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February 26, 2009

DOJ Joins Whistleblower Lawsuit Against Johnson & Johnson

Filed under: Big Pharma, FDA, Vioxx, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 10:26 am

Seeking repayment for federal health claims, the Department of Justice is continuing its war on Big Pharma’s rampant off-label marketing by joining two ‘whistleblower’ suits by two former sales managers against J&J’s Scios Inc., maker of heart drug Natrecor.

Two ‘whistleblower’ lawsuits against the Scios Inc. unit of Johnson & Johnson, alleging improper off-label marketing of the heart-failure drug Natrecor, has been joined by the federal Dept. of Justice.

The DOJ will seek repayment of as-yet undetermined amounts of Medicare and other federal health insurance claims it paid out for uses if the drug that were unapproved by the FDA.

As you know, physicians can legally prescribe drugs for off-label uses, but FDA regulations forbid drug companies from promoting such uses. But that is exactly what Scios did, and did in spades, claim the two whistleblowers, both former Scios sales managers.

The thing is, Scios’ marketing tactics for Natrecor is not news. Back in 2005, Dr. Eric Topol of the Cleveland Clinic charged in a medical journal that Scios was aggressively marketing Natrecor for repeated administration in outpatient settings for a “tune-up.” Yet Natrecor was approved by the FDA in 2001 only for a serious type of acute congestive heart failure accompanied by shortness of breath. Topol reported that Scios was even showing doctors how to bill Medicare for the off-label treatments.

Topol went on to describe the regimen the company recommended, using nearly 10 times the amount of the drug administered to acute-care patients in hospitals as approved, resulting in fees of as much as $700 per dose to the doctors.

Dr. Steve Nissen, who later succeeded Topol at the Cleveland Clinic as cardiology chief, was the only FDA adviser to vote against Natrecor, after he found research that tied it to an increased risk of death. Nissen, as you might recall, has become known as a whistleblower of sorts himself, publishing medical journal articles warning about the real risks of the diabetes drug Avandia, the painkiller Vioxx, the anticoagulant Exanta, and the blood pressure drug Vanlev, among others.

According to the Wall Street Journal Health Blog, in cases where the DOJ seeks to recover damages based on federal health coverage paid for off-label uses, state attorneys general often join in, and the stakes can be high. A few weeks ago Pfizer took a $2.3 billion charge for off-label marketing of the painkiller Bextra after a federal probe.

GlaxoSmithKline also took a $400 million charge for marketing and promotional practices for several products recently, and Eli Lilly paid $1.4 billion in a recent settlement over marketing for its antipsychotic Zyprexa. And, a few months earlier, Cephalon agreed to a $444-million settlement in state and federal probes of its sales and marketing practices.

The FDA, while failing to protect Americans from health risks associated with drugs, has demonstrated no capability of policing the illegal financial gouging by criminals in the pharmaceutical industry who flaunt the FDA’s own rules. Without an aggressive DOJ, a few members of Congress, and occasional Big Pharma whistleblowers, we’d have no one trying to protect us.

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September 29, 2008

Insider Tell-all Reveals How High, And How Deep, The Vioxx Scandal Reached

Filed under: Big Pharma, FDA, Merck, Vioxx, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 10:22 am

“Drawing on internal Merck documents, court testimony, and exclusive interviews, as well as three decades of experience inside the medical industry, author Tom Nesi tells the dramatic story of what the drug’s manufacturer, Merck, knew and when.”

The editorial review at Amazon for Poison Pills: The Untold Story of the Vioxx Drug Scandal, by Tom Nesi (from Thomas Dunne Books) introduces the characters and the plot of a story few people could imagine in a new book that reads more like a mystery novel as it delves deeply into a scandal that rocked Big Pharma and has seen Merck settle with plaintiffs for roughly $50 billion (yes, BILLION) — and it’s not over yet.

Tom Nesi, a former PR director for Bristol-Myers Squibb and a 30-year veteran of the pharmaceutical industry, takes us through the corporate intricacies behind the rise and fall of the painkiller Vioxx, a $20-billion bonanza for Merck & Co. that crashed and burned in late 2004 after it was revealed it could cause heart attacks and death.

For those who don’t know about the Vioxx case, here is some background, some more here, and even more here.

The book ranges across the history of Big Pharma, and follows the breakdown of the US medical system, the failures of the FDA, and the staggering profits earned by a pharmaceutical industry at the cost of thousands of lives.

In a recent interview with Ed Silverman of Pharmalot, Nesi says the book idea came after he had begun researching the case, and realized here was “a much bigger story than anybody could believe.”

Some juicy Nesi quotes:

“Chicanery has been part and parcel of the pharmaceutical industry since whenever. So no, it’s not really new. But what sets the Vioxx story apart, or makes it unique, was the scope. Yes, it’s happened before that we’ve seen chicanery, but the level of the characters, the stars, the advertising . . . there were billions of dollars spent on marketing, the doctors involved, the samples handed out. And this was not just an action by Merck. There was total failure — the FDA, the New England Journal of Medicine, opinion leaders. It went on and on, and infected everything.”

“Merck knew full there were many times more heart attacks in the Vioxx group versus the naproxen group . . . and they issued a press release reaffirming the cardiovascular safety of Vioxx anyway . . . The whole effort to position the drug was a company-wide strategy.”

“The similarities between Vioxx and Vytorin are very frightening — and the fact that the FDA will have to take six months, at least, to evaluate the data is absurd. That is the amount of time it takes to get a fast track approval. Why isn’t the agency calling an emergency meeting as we speak?”

For anyone with even a passing interest in the billions of pills we take every day, the pills we are coaxed, persuaded, urged and exhorted to consume with ever-increasing fervor by Big Pharma and its medical minions, and the roles that the Food and Drug Administration and our government play in this deadly game of pharmaceutical roulette, this book is a must-read.

As one Amazon reviewer commented, you may hesitate to even take an aspirin ever again.

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September 22, 2008

Why More States Are Suing Big Pharma Over Psych Drug Marketing

Filed under: Big Pharma, Merck, Vioxx, Zyprexa, pharmaceutical giants, pharmaceutical sales — Rod Malcolm @ 8:58 am

A Utah assistant attorney general says Big Pharma has overcharged Medicaid, misled the FDA about drug safety, and improperly encourages off-label, unsafe drugging of children.

More states are filing lawsuits against Big Pharma over allegations of failing to disclose side effects and for improper marketing of antipsychotics, resulting in state Medicaid overpayments.

In a recent Pharmalot blog, Ed Silverman asked Utah special assistant attorney general David Stallard to explain why so many states are on the legal warpath against several Big Pharma antipsychotic makers.

Last year, Utah became the eighth state to sue Eli Lilly alleging the drugmaker hid side effects and risks of Zyprexa — weight gain and diabetes — while ‘illegally’ promoting off-label prescribing for the drug.

Stallard, who has spent several years working exclusively on pharmaceutical Medicaid fraud in Utah, said Medicaid sales are a huge business for pharmaceutical companies, and a very attractive market — what he called “feeding at the taxpayer trough.”

“Pharmaceutical companies try to get as much reimbursement as they can from Medicaid, because it’s a big payer,” Stallard said. “And not just on price, but utilization. As many pills as they can, and the highest price they can engineer.”

Merck’s Vioxx and Lilly’s Zyprexa are the two main targets in Utah, Stallard said, for “what I call failure to warn — risks we allege were known early on by the company but concealed” from the public, the FDA and the medical community.

Stallard says there was also pricing fraud — overcharging Medicaid by falsely inflating list prices. And in the case of Lilly, there was a lot of off-label use that was promoted improperly by Lilly, which is illegal federally, but which Utah is pursuing under state law alleging the practice caused Utah to pay more than it should have.

But the perhaps the biggest issue that could come from Utah’s cases will derive from Stallard’s analysis of federal and state Medicaid payment regulations, which require a drug to be a covered outpatient drug that “has to be used for a medically accepted indication.”

And a doctor legally, at his own whim, prescribing a medication for off-label use does not qualify it for Medicaid support. “That’s a separate issue … In order to get federal funding, Medicaid programs must comply with federal law.”

Stallard says he is opposed to the uncontrolled drugging of children with atypical antipsychotics, for which none have been approved, and it isn’t about the money it has been costing the state.

“I think they shouldn’t be experimenting when it’s never been tested on children. It’s a big mistake. Sometimes, legislators say they need to be liberal with vulnerable segments of society to give them medicines that may have some benefit. I turn it around and say we shouldn’t be experimenting with the most vulnerable segments of our society.”

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August 22, 2008

The Smoking Gun: Merck Memos Prove Vioxx Study Was A Marketing Ploy

Filed under: Big Pharma, Merck, Vioxx, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 8:40 am

Big Pharma has been suspected for years of “seeding” research studies to gain marketing benefits, but there was no “smoking gun” proof until Vioxx litigators unearthed internal Merck memos.

Proof that Merck & Co. “seeded” a research study into the comparative benefits of its painkiller Vioxx — the now-withdrawn drug that has brought Merck a hailstorm of lawsuits for alleged side effects — has come to light during litigation research.

According to an AP News story this week, the study was “primarily a stealth marketing strategy”, the real purpose of which was to get lots of doctors and patients into the habit of using Vioxx in time for the product launch.

“Seeding” refers to loading a study project with physicians who are inexperienced in clinical research. Merck’s Vioxx study employed some 600 family doctors new to clinical research. Each doctor received a stipend plus fees for recruiting a handful of patients to participate. Clinical trials are usually conducted by a few experienced specialists at major teaching hospitals that each recruit hundreds of patients.

Merck touted the 1999 study, called ADVANTAGE, to participating doctors and patients as a means of showing whether Vioxx caused fewer stomach problems than another painkiller, naproxen. The company maintains it was a valid scientific inquiry.

But doctors hired to review roughly a million Merck documents for plaintiffs’ lawyers preparing for trials in Vioxx lawsuits found internal Merck memos discussing the marketing strategy behind the study — some even showing it was designed by the marketing division.

According to the Annals of Internal Medicine, which published Merck’s original report on ADVANTAGE in 2003, it was misled by the faux science and published the results. But now it says drug companies have been suspected for years of doing “seeding” studies — bogus, marketing-driven “research” thinly disguised as science — and says the magazine will publish the new findings later this month.

Ah, Big Pharma — you can run, but you can’t hide.

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May 25, 2008

Merck To Pay $58M To Settle Multistate Lawsuit Claiming Vioxx Ads Played Down Health Risks

Filed under: FDA, Vioxx, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 4:45 pm

Merck must submit all new television ads for its drugs to the FDA for seven years, and follow through with agency-suggested changes before airing them.

This week, Merck and Co. agreed to pay a $58 million settlement with 29 states and the District of Columbia to stop investigating allegations that it downplayed cardiovascular risks caused by the COX-2 inhibitor Vioxx in its consumer advertisements dating back to 1999. Of course, to a major drug firm, $58 million is chump change.

Before Merck withdrew Vioxx from the market in 2004, it was linked to tens of thousands of heart attacks and strokes — research found that it doubled the risk. The company has already agreed to a $4.85 billion settlement, which is still pending, to end a majority of the public lawsuits that followed these findings.

As we reported in our recent Big Pharma scams blog, a study of internal Merck documents showed that the company knew of the dangers of Vioxx years earlier, but falsified statistics to hide them from the FDA.

Under this new settlement, Merck has also “agreed” to end its practice of so-called “medical ghostwriting” of research reports. In our recent blog about ghost writing, we reported how Merck faked reports on Vioxx by having Merck employees write them, then attributed the articles to academics paid by the company to use their names.

This raises an obvious question: How is FDA planning to police ghost writing? Over at the Hooked: Ethics, Medicine and Pharma blog, Howard Brody comments: “. . . given the secrecy with which ghostwriting of scientific papers occurs, how are we to know about compliance?” Exactly.

Finally, also part of the new settlement, Merck has agreed to submit all new television ads for its drugs to FDA for seven years, and to comply with agency-suggested changes before airing them. And the Pennsylvania Attorney General’s office, one of the states involved in the suits, added that the commercials don’t require court approval — just FDA approval.

Once again, that’s asking the fox to guard the hen-house. We only need to glance at what the FDA was doing about Vioxx during the five years it made Merck billions of dollars while killing or injuring thousands. Back in 2001, the FDA warned Merck that its ads failed to inform consumers about cardiovascular risks of Vioxx. Hello? The drug wasn’t pulled until 2004 — three years and thousands of heart attacks and strokes later.

A 2007 Pharmaceutical Research and Manufacturers of America report states that most drug makers already voluntarily submit their ads to the agency. But the number of FDA enforcement actions to pull misleading drug advertisements has dropped sharply since then. And Big Pharma has increased its consumer ad spending fourfold in the last 10 years — while the number of FDA warning letters has fallen 86% over the same period. Are we supposed to believe that’s because Big Pharma’s ads are now completely informative?

Okay, so the FDA is “under new management” so to speak, and according to some reports it’s getting whipped into some semblance of action, mainly because of the current Congressional and state investigations swarming around Big Pharma’s practices. But starting to wake up and do something is still a long way from effectively protecting America from the criminal actions for which Big Pharma has become notorious.

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April 28, 2008

Big Pharma Scams Do No Good For The Industry, And Let’s Not Forget They Often Kill People

Filed under: Big Pharma, Vioxx, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 4:35 pm

Merck and Schering-Plough are not the only Big Pharma players getting hurt by their own actions.

Before Merck and Co. withdrew the painkiller Vioxx in 2004, it was linked to tens of thousands of heart attacks. Now a new study of internal Merck documents alleges the company knew of the dangers years earlier, but falsified statistics to hide them from the FDA.

In the five years it was on the market, Vioxx was a blockbuster for Merck that generated billions of dollars. When it was eventually linked to heart attacks and strokes, the product was pulled from the market. Earlier this year, Merck agreed to almost $5 billion in compensation to the victims of the Vioxx — I hesitate to use it, but there’s just no other word to describe it — scam.

A scam is “a confidence game or other fraudulent scheme, especially for making a quick profit.” A popular synonym is the word “swindle”. And that’s exactly what Merck, a Big Pharma player, worked on its millions of patients, their physicians, and before that, the Food and Drug Administration that approved the drug.

Now Merck is embroiled in another possible scam, this one over its massively profitable — $5.1 billion in 2007 — cholesterol drug Vytorin, a combination of Merck’s Zocor and Schering-Plough Corp.’s newer drug Zetia. An ongoing study shows that Vytorin is no more effective than cheaper, generic versions of the statin drug Zocor at reducing plaque buildup. The report has doctors nationwide reverting to older, cheaper statin drugs. And Congress is investigating whether the two companies withheld the unfavorable study results to boost sales.

In spite of widespread public concerns about the FDA’s effectiveness at protecting us from drug dangers, the agency appears to be stepping up to plate with Merck.

The FDA has rejected Merck’s application to sell the cholesterol drug Mevacor over the counter, and it has begun an investigation into the asthma and allergy drug Singulair, linking it to higher rates of suicide. Merck had already updated the drug’s warning label about side effects including tremors, anxiousness, depression and suicidal behavior, but further investigation may reveal more problems.

Merck shares fell 35 percent in the first quarter, much of the loss due to the Vioxx scandal, according to Wall Street analysts. The company is far from the only Big Pharma player in trouble, as scams, swindles and scandals continue to surface across the playing field. According to Ed Silverman in his Pharmalot blog, Schering-Plough’s share prices have been “ravaged” by the Vytorin controversy, caused “massive layoffs”, and in general “sullied the company’s reputation.”

Well, as the old saying goes, if the shoe fits . . .

There are plenty of laws on the books, at all levels of government, designed to protect the public from scams and swindles. It’s time for our lawmakers to take a very long hard look at how Big Pharma is being regulated and its products are tested and approved. And part of the scrutiny needs to be directed at the FDA itself. A lot of people need reassurance that the scams aren’t getting some help from Big Pharma friends on the inside.

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