The Battles

Sent: June 03, 2007

I am sending these articles to some health officials.
/Sandra

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Thanks to Hart Haidn:

June 3, 2007

After Sanctions, Doctors Get Drug Company Pay

By GARDINER HARRIS and JANET ROBERTS

A decade ago the Minnesota Board of Medical Practice accused Dr. Faruk Abuzzahab of a “reckless, if not willful, disregard” for the welfare of 46 patients, 5 of whom died in his care or shortly afterward. The board suspended his license for seven months and restricted it for two years after that.

But Dr. Abuzzahab, a Minneapolis psychiatrist, is still overseeing the testing of drugs on patients and is being paid by pharmaceutical companies or the work. At least a dozen have paid him for research or marketing since he was disciplined.

Medical ethicists have long argued that doctors who give experimental medicines should be chosen with care. Indeed, the drug industry’s own guidelines for clinical trials state, “Investigators are selected based on qualifications, training, research or clinical expertise in relevant fields.” Yet Dr. Abuzzahab is far from the only doctor to have been disciplined or criticized by a medical board but later paid by drug makers.

An analysis of state records by The New York Times found more than 100 such doctors in Minnesota, at least two with criminal fraud convictions. While Minnesota is the only state to make its records publicly available, the problem, experts say, is national.

One of Dr. Abuzzahab’s patients was David Olson, whom the psychiatrist tried repeatedly to recruit for clinical trials. Drug makers paid Dr. Abuzzahab thousands of dollars for every patient he recruited. In July 1997, when Mr. Olson again refused to be a test subject, Dr. Abuzzahab discharged him from the hospital even though he was suicidal, records show. Mr. Olson committed
suicide two weeks later.

In its disciplinary action against Dr. Abuzzahab, the state medical board referred to Mr. Olson as Patient No. 46.

“Dr. Abuzzahab failed to appreciate the risks of taking Patient No. 46 off Clozaril, failed to respond appropriately to the patient’s rapid deterioration and virtually ignored this patient’s suicidality,” the board found.

In an interview, Dr. Abuzzahab dismissed the findings as “without heft” and said drug makers were aware of his record. He said he had helped study many of the most popular drugs in psychiatry, including Paxil, Prozac, Risperdal, Seroquel, Zoloft and Zyprexa.
The Times’s examination of Minnesota’s trove of records on drug company payments to doctors found that from 1997 to 2005, at least 103 doctors who had been disciplined or criticized by the state medical board received a total of $1.7 million from drug makers. The median payment over that period was $1,250; the largest was $479,000.

The sanctions by the board ranged from reprimands to demands for retraining to suspension of licenses. Of those 103 doctors, 39 had been penalized for inappropriate prescribing practices, 21 for substance abuse, 12 for substandard care and 3 for mismanagement of drug studies. A few cases received national news media coverage, but drug makers hired the doctors
anyway.

The Times included in its analysis any doctor who received drug company payments within 10 years of being under medical board sanction. At least 38 doctors received a combined $140,000 while they were still under sanction. Dr. Abuzzahab received more than $55,000 from 1997 to 2005. Drug makers refused to comment, said they relied on doctors to report disciplinary or criminal cases, or said they were considering changing their hiring systems.

Asked about the Minnesota analysis, the deputy commissioner and chief medical officer of the Food and Drug Administration, Dr. Janet Woodcock, said the federal government needed to overhaul regulations governing clinical trials and the doctors who oversaw them. “We recognize that we need to modernize the F.D.A. approach in keeping people safe in clinical trials,” Dr. Woodcock said.
Drug makers are not required to inform the agency when they discover that investigators are falsifying data, and indeed some have failed to do so in the past. The F.D.A. plans to require such disclosures, Dr. Woodcock said. The agency inspects at most 1 percent of all clinical trials, she said.

Karl Uhlendorf, a spokesman for the Pharmaceutical Research and Manufacturers of America, said the trade group would not comment on The Times’s findings.

The records most likely understate the extent of the problem because they are incomplete. And the Minnesota Board of Medical Practice disciplines a smaller share of the state’s doctors than almost any other medical board in the country, according to rankings by Public Citizen, an advocacy group based in Washington.

Dr. David Rothman, president of the Institute on Medicine as a Profession at Columbia University, said the Times analysis revealed a national problem. “There’s no reason to think Minnesota is unique,” Dr. Rothman said.

“Clinical trial investigators must be culled from only the finest physicians in the country,” he said, “since they work on the frontiers of new knowledge. That drug makers are scraping the bottom of the medical barrel is an outrage.”

Payments by drug companies to doctors, whether or not the doctors have been disciplined, are a matter of much debate. Drug makers and doctors say the money finances vital research and helps educate doctors about helpful medicines. But others in the medical profession say the payments are thinly disguised incentives for doctors to prescribe more, and more expensive,
drugs. Among the other doctors who were disciplined or criticized by the board and paid by pharmaceutical companies:

¶Dr. Barry Garfinkel, a child psychiatrist from Minneapolis who was convicted in federal court in 1993 of fraud involving a study for
Ciba-Geigy. His criminal case made headlines across the state. From 2002 to 2004, Eli Lilly paid him more than $5,500 in honoraria, according to state records.

Dr. Garfinkel said in an interview that he had wondered why drug makers would hire him as a speaker considering his statewide notoriety. He decided that “they’re hiring me to influence my prescribing habits,” so he quit giving sponsored talks and taking money from drug makers, he said.

¶Dr. John Simon, a Minneapolis psychiatrist who for years shared an office with Dr. Abuzzahab and was told by the state medical board in 1994 to complete a clinical training program after it concluded in a report that he “frequently makes abrupt and drastic changes in type and dosage of medication which seem erratic, not well considered and poorly integrated with nonmedication strategies.” He prescribed addictive drugs to addicts and failed to stop giving medicines to patients suffering severe drug side
effects, the board concluded.

Dr. Simon earned more than $350,000 from five drug makers from 1998 to 2005 for consulting and giving drug marketing talks. Of this, Eli Lilly paid more than $314,000. Dr. Simon said in an interview that the board’s action was a learning experience, and that drug makers continued to hire him to speak because “I am respected by my peers.”

Asked about Drs. Garfinkel and Simon, Phil Belt, a spokesman for Eli Lilly, said that both doctors were licensed to practice medicine and that the company relied on doctors to report disciplinary actions or criminal convictions against them.

¶Dr. Ronald Hardrict, a psychiatrist from Minneapolis who pleaded guilty in 2003 to Medicaid fraud. In 2004 and 2005, he collected more than $63,000 in marketing payments from seven drug makers. In an interview, Dr. Hardrict said 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, and I use Risperdal because it works,” Dr. Hardrict said, referring to an antipsychotic medicine for schizophrenia. Johnson & Johnson, the maker of Risperdal, paid Dr. Hardrict more than $30,000 in 2003 and 2004.

Srikant Ramaswami, a spokesman for Johnson & Johnson, said the company removed Dr. Hardrict as a speaker in 2004 when, as a result of his conviction, his name appeared in a government database. Asked why other drug makers continue to hire him despite a fraud conviction, Dr. Hardrict responded with an e-mail message stating only, “I will pray for you daily.”

In cases involving Dr. Abuzzahab over 15 years in the 1980s and ’90s, the medical board found that he repeatedly prescribed narcotics and other controlled substances to addicts, renewing one patient’s prescriptions six weeks after the patient was jailed and telling another that his addictive pills should be thought of as “Hamburger Helper.” He prescribed narcotics to pregnant patients, one of whom prematurely delivered a baby who soon died.

In explaining his abrupt discharge of the suicidal Mr. Olson, Dr. Abuzzahab told the medical board that “if a patient is determined to kill himself, he can’t be prevented from doing it and hospitalization postpones the event,” records show.

Mr. Olson’s sister, Susie Olson, said Dr. Abuzzahab “had no time for my brother unless David agreed to get into a drug study. He said, ‘You’re wasting my time and the hospital’s.’ It was all about money.”

Separately, the F.D.A. in 1979 and 1984 concluded that Dr. Abuzzahab had violated the protocols of every study he led that they audited, and reported inaccurate data to drug makers. He routinely oversaw four to eight drug trials simultaneously, often moved patients from one study to another, sometimes gave experimental medicines to patients at their first consultation, and once hospitalized a patient for the sole purpose of enrolling him in a study, the F.D.A. found. Dr. Abuzzahab, 74, was president of the Minnesota Psychiatric Society and two decades ago was chairman of its continuing education and ethics committees. He would not discuss the specifics of his disciplinary record, saying he did not have the time. But in 1998 he signed an agreement with the
board saying that his conduct “constitutes a reasonable basis in law and fact to justify the disciplinary action.”

A simple Google search reveals Dr. Abuzzahab’s 1998 medical board disciplinary file, which was reported at the time by a local newspaper and a TV station. In 1998, The Boston Globe featured Dr. Abuzzahab in a front-page article questioning the safety of psychiatric drug experiments. And in 1999, the NBC program “Dateline” did a segment about a woman who committed suicide
while in a drug experiment he supervised.

In June 2006, the medical board criticized Dr. Abuzzahab, this time for writing narcotics prescriptions for patients he knew were using false names, a violation of federal narcotics laws. Despite all this, drug makers continued to hire him. Dr. Abuzzahab’s résumé
lists 11 publications or research presentations since 2000, when the medical board lifted its restrictions on his license.

Takeda, a Japanese drug maker, confirmed that Dr. Abuzzahab was doing a study financed by the company on its sleep medicine, Rozerem. Eisai, another Japanese drug maker, said that although Dr. Abuzzahab had signed a clinical trial agreement with the company to study its Alzheimer’s drug, Aricept, it told him two days after a reporter asked for comment on the case that he was
not qualified to be an investigator. And at AstraZeneca, for which Dr. Abuzzahab said he had performed clinical trials and still gave drug marketing lectures, a spokesman said the company was “concerned” about Dr. Abuzzahab’s disciplinary record.

“We have our own internal processes for dealing with these matters, which are under way,” said Jim Minnick, an AstraZeneca spokesman.

The Minnesota records often fail to distinguish between drug company payments to doctors for research and for marketing, so it is sometimes impossible to determine why doctors were paid. Some doctors, like Dr. Abuzzahab, clearly performed both research and marketing. Gene Carbona, who left Merck on good terms in 2001 as a regional sales manager after 12 years in drug sales, said the only thing the company considered when hiring doctors to give marketing lectures was “the volume or potential volume of prescribing that doctor could do.” A Merck spokesman declined to comment.

Mr. Carbona, now executive director of sales for The Medical Letter, which reviews drugs, said that had he known that a doctor had a disciplinary record for excessive prescribing, “I would have been more inclined to use them as a speaker.”

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from yesterday’s email:

(3) THE INDEPENDENT, MAY 31, US PHARMACEUTICAL GIANT PFIZER SLAPPED WITH CRIMINAL CHARGES IN NIGERIA OVER NOTORIOUS CLINICAL TRIAL IT CONDUCTED ON CHILDREN

http://www.commondreams.org/contactingus.htm

Friday, June 01, 2007

Published on Thursday, May 31, 2007 by the Independent/UK

Drugs Giant Faces Criminal Charges Over Clinical Trial
by Andrew Gumbel

LOS ANGELES – The US pharmaceutical giant Pfizer has been slapped with criminal charges in Nigeria over a notorious clinical trial it conducted on children during a meningitis epidemic a decade ago. Patients became unwitting guinea pigs for a new, untested antibiotic and many of them either died or were left with permanent disabilities.

Pfizer and its representatives will be called to account at hearings due to begin next month in the Nigerian state of Kano, where public anger over the clinical trial – and the assurances of any pharmaceutical company – remains so high that the local population won’t even trust the Nigerian government to immunise their children against polio.

The episode, which has already led to one unsuccessful suit in the US courts, was the inspiration for John Le Carré’s novel The Constant Gardener and is frequently held up as an instance of scientific inquiry gone shockingly awry.

The Nigerian authorities say Pfizer researchers selected 200 children and infants from a crowded epidemic camp in Kano in 1996 and gave about half of them an untested antibiotic called Trovan. The lawsuit alleges that the researchers did not obtain consent from the children’s families even though they knew from their own research that Trovan might have life-threatening side effects and was “unfit for human use”.

The suit further contends that the researchers gave the other half a comparison drug made by Pfizer’s competitor Hoffman-La Roche, but deliberately underdosed them to make their own product look better. Pfizer and its doctors “agreed to do an illegal act,” the suit says, “in a manner so rash and negligent as to endanger human life”.

Once the trial was over, the suit continues, Pfizer left the area, removed all medical records and “obliterated any evidence” of the trial. A Nigerian government report, which appears to have spurred the criminal charges, previously found that Pfizer never told the children or their parents they were participating in a trial and did not inform them that alternative treatments were available – most obviously chloramphenicol, a relatively cheap antibiotic usually recommended for bacterial meningitis.

The government report found that of the 11 children who died, five were taking Trovan and six were taking low doses of the comparison drug, ceftriaxone. An unknown number suffered deafness, blindness, paralysis and other disabilities.

The Kano authorities have charged Pfizer on eight counts of criminal conspiracy and voluntarily causing grievous harm. They have also filed a civil suit seeking more than $2.7bn (£1.3bn) in damages. Pfizer has responded to the lawsuit by insisting it did nothing wrong. “Pfizer continues to emphasize – in the strongest terms – that the 1996 Trovan clinical study was conducted with the full knowledge of the Nigerian government and in a responsible and ethical way consistent with the company’ s abiding commitment to patient safety,” a company statement said. “Any allegations in these lawsuits to the contrary are simply untrue – they weren’t valid when they were first raised years ago and they’re not valid today.”

Back in 1997, when Pfizer faced a US government audit of its records on Trovan, the company produced a letter from a hospital in Kano saying its study had been approved by the hospital’s ethics committee. The company’s accusers contend that the letter was fabricated after the fact, using a forged letterhead. The hospital, according to the suit, has no ethics committee.

Nigeria’s decision to prosecute Pfizer marks the first known instance of a Third World country going after a pharmaceutical multinational. Until now, the Nigerians have trod very carefully around the issue – commissioning an investigation but then suppressing the results until they were leaked to The Washington Post a few years ago.

But the episode has got in the way of successive public initiatives, including a polio vaccination drive that prompted an 11-month boycott in Kano.

Trovan has never been approved for use on US children. It was cleared for adults in 1997, but its use was restricted two years later following reports of liver damage and death. It is banned throughout Europe.

© 2007 Independent News and Media Limited

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Email from:
Sandra Finley, Saskatoon
Email network started in year 2000 – www.sandrafinley.ca
Joined Green Party in May 2006
Leader, Green Party of Saskatchewan, Oct 2006