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.

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