Yet another Jim Thomson initiative…

I notice on the website of the Centre for Mental Health a news item about the Zyprexa recall in the UK…

Interesting to note that Jim Thomson is still against the parallel trade in drugs: “The Centre has long campaigned on our belief that the (presently legal) free movement of medicines in Europe is a potential weakspot in the supply chain and an open invitation to criminal counterfeiters who prey on vulnerable patients. It is well known that medicines counterfeiting is a source of funds to organised crime and international terrorism.”

Is it well known Jim?

I’d like to see the evidence of a proven link between medicines counterfeiting and international terrorism – you see, I thought the link was between DVD piracy and international terrorism – or was it CD piracy and international terrorism? – or was it counterfeit handbags and international terrorism?

Anyway, Jim goes on “…our committment to protecting patients has led us and a number of partners to form the European Alliance for Access to Safe Medicines (EAASM).”

Great – just what we need – yet another ‘Alliance’. Now, I wonder who the partners are…

Jim is Chair of the EAASM and continues to be CEO of the Centre for Mental Health.

I’ll be interested to watch how the EAASM develops and I hope I’ll be able to report back to you with full details of the founding (and funding) partners, as well as to inform you all exactly what the aims of the organisation are.

Until I can find out more, just remember what Jim himself says “…ask yourself one question… What does this person, or this organisation, have to gain from taking this position?”

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Clinical trials – honest and true?

This story comes from the AHRP blogspot via The New York Times. A front page investigative report by Gardiner Harris and Janet Roberts blows the lid off the perception that prescription drugs approved by the FDA have all passed scientifically rigorous clinical trials, and that doctors testing those drugs are held to high standards of professional integrity.

The Times’ lead anecdotal example involves the former president of the Minnesota Psychiatric Society who, after having been repeatedly disciplined and his license temporarily revoked for willfully disregarding the welfare of his patients, including several who committed suicide, continues earning tens of thousands of dollars from at least a dozen drug companies for either testing or promoting their new drugs. Psychiatrist Dr. Faruk Abuzzahab is no ordinary anecdotal “bad apple,” he represents the norm and practice in psychiatry. Indeed he served as chairman of the Minnesota Psychiatric Society’s ethics committee. The Times documented gross negligence and violations of professional practice standards in the conduct of drug trials—including “reckless, if not willful disregard for patients”—resulting in deaths and preventable suicides by patients entrusted to their care. But as the Times documents, despite repeated disciplinary actions against him, Dr. Abuzzahab’s career—judging by his income–did not appear to suffer one bit after being found repeatedly in violation of professional standards of care–including prescribing narcotics to drug addicts.

In 1994, he enrolled Susan Endersbe, a suicidal patient, into a drug trial for which he was paid by a corporate sponsor. He later admitted to state investigators that he had ignored study criteria that excluded patients who were suicidal. As soon as he withdrew Ms. Endersbe from the antidepressant, Effexor (venlaxafine), she quickly worsened—as recorded by the hospital nurses—state investigators reported. Indeed, the SSRI-SNRI antidepressant drugs are highly addictive—as demonstrated by severe, even suicidal withdrawal symptoms patients experience when they abruptly stop taking the drugs (in clinical trials this is called, “wash out” a.k.a “cold Turkey”). But Dr. Abuzzahab falsified the record by recording her adverse effects as “0”.

Susan Endersbe’s brother said he was stunned to learn years later from The New York Times that Dr. Abuzzahab was still overseeing clinical trials. “He should not be allowed to harm anyone else.”

In addition to Dr. Abuzzahab, the Times cites the following psychiatrists: *Dr. Barry Garfinkel, a child psychiatrist who was convicted in federal court in 1993 of fraud involving a study for Ciba-Geigy. *Dr. John Simon, a psychiatrist, who prescribed addictive drugs to addicts and failed to stop giving medicines to patients suffering severe drug side effects *Dr. Ronald Hardrict, a psychiatrist who pleaded guilty in 2003 to Medicaid fraud; collected more than $63,000 in marketing payments from seven drug makers; claiming that it was “insulting” and “ridiculous” to suggest that income from drug makers might influence doctors’ prescribing habits. “I bought the Mercedes because it has air bags…”

The hazardous drugs approved under these dubious circumstances include many of the most profitable drugs in psychiatry: Paxil, Prozac, Risperdal, Seroquel, Zoloft and Zyprexa.

You can read the full story here.

Avandia critic to tell how he “was intimidated by Glaxo.”

This story by Stephanie Saul from the New York Times:

When a Congressional committee holds a hearing on Wednesday, the subject will be the safety of the diabetes drug Avandia and whether federal drug regulators have paid close enough attention to its potential risks.

But for one witness who is scheduled to appear, Dr. John B. Buse, a nationally noted diabetes specialist, the hearing will take a different turn, focusing on whether he was the target of an effort by the drug’s maker, GlaxoSmithKline, to silence his criticism of the drug.

In a statement last night, Dr. Buse said his full story would be told at the hearing, including the account of how he was intimidated by Glaxo. But he said the company apologized and he later reported his concerns about the drug to the Food and Drug Administration.

“It was upsetting, but it was not life-altering,” Dr. Buse’s statement said. “I hold no ill will toward Glaxo or any of its employees.”

Congressional investigators have been looking into what they have called “very serious” claims that Avandia’s maker “silenced one or more medical professionals who attempted to speak out about the potential for cardiovascular problems with Avandia,” according to a letter to Glaxo last week from the Senate Finance Committee.

Glaxo denied yesterday that it made any effort to stifle a scientific discussion of its drug, used for Type 2 diabetes. Avandia is the company’s second-largest product with more than $3 billion in sales last year.

Dr. Buse has declined to discuss any details of his story, saying he wanted them to come out during sworn testimony. But one of his friends, a University of Michigan diabetes expert, Dr. Charles F. Burant, said that Dr. Buse had been troubled by the pressure he had received from Glaxo.

Dr. Burant said he was not familiar with specifics, but that the pressure had included Glaxo’s contacting the University of North Carolina medical school, where Dr. Buse was then on the faculty and is now the head of endocrinology.

Although Glaxo is based in London, it has major operations in Research Triangle Park, N.C., and the company’s foundation has donated millions of dollars to the University of North Carolina.

Dr. Buse, who is about to become the president of the American Diabetes Association, was an early and frequent critic of Avandia after it reached the market in 1999. In a March 2000 letter to the F.D.A., he said Avandia might raise patients’ risk of heart attacks, and he criticized the company’s marketing, saying it employed “blatant selective manipulation of data” to overstate the drug’s benefits and understate its risks.

The following year, after demanding that Glaxo strengthen the language on Avandia’s label describing its potential heart risks, the F.D.A. sent Glaxo a letter reprimanding the company for playing down those risks in discussions between sales representatives and undercover investigators at a medical conference.

Dr. Buse, meanwhile, had also raised his concerns about Avandia in speeches to other doctors. Avandia, an oral medication, is used for a patient population already at increased risk for heart disease.

More recent questions about Avandia’s potential risks, as outlined in a New England Journal of Medicine article last week, have prompted the Congressional hearing. The author of that article, Dr. Steven E. Nissen, a heart specialist at the Cleveland Clinic, has also been called to testify.

In an interview this week, Glaxo’s president of United States operations, Chris Viehbacher, acknowledged that the company was looking for any records that would shed light on the accusations that it tried to suppress Dr. Buse’s criticisms. Mr. Viehbacher said that the events occurred years ago and that the employee who was thought to have been involved had left the company.

In that interview, Mr. Viehbacher repeated Glaxo’s ’s contention that Avandia’s risks were in line with those of other diabetes medications.

Yesterday, in a written statement issued by a spokeswoman, Mary Anne Rhyne, the company said: “Discussions occurred with Dr. John Buse in 1999 and 2000 regarding his views on Avandia, and we had a scientific disagreement that was later resolved. We regret if, at any time, Dr. Buse felt the conduct of any GSK employee was contrary to the spirit of open, scientific debate regarding his views on Avandia.” The statement also said that the company “does not condone any efforts by GSK’s staff to limit an individual’s ability to discuss or publish adverse events related to Avandia.”

Dr. Buse’s friend, Dr. Burant, said in a telephone interview, “I never wrote a prescription for Avandia because of the heavy-handed way Glaxo treated John Buse.”

When Glaxo sales representatives have asked him why he was not prescribing Avandia, “I was very straight with them,” Dr. Burant recalled.

“When they were giving John a hard time, I just told them that if this is the way you’re going to treat people who are doing their usual scientific review of the product, it’s not the kind of company I’m going to support,” Dr. Burant said. “I just told them flat-out.”

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