Posts Tagged ‘Mother Jones’

Professor of Bioethics—Co-opted by market forces, clinical drug trials are now just covert instruments for promoting drugs

Friday, August 20th, 2010

MinnPost.com

By Susan Perry |

In the September issue of Mother Jones magazine, Dr. Carl Elliott, a professor of bioethics at the University of Minnesota, writes about the suicide in 2004 of 26-year-old Dan Markingson, who was enrolled at the time in a U of M industry-funded clinical trial of the antipsychotic drug Seroquel (quetiapine).

It’s a disturbing tale (the unsuccessful efforts of Markingson’s mother to get her son released from the trial and into other treatment are particularly heartbreaking) and one that, as Elliott acknowledges, was first told in the Pioneer Press by Jeremy Olson and Paul Tosto.

But Elliott’s purpose in writing the article wasn’t only to revisit the tragic details of Markingson’s story. “[T]he more I examined the medical and court records, the more I became convinced that the problem was worse than the Pioneer Press had reported,” he writes. “The danger lies not just in the particular circumstances that led to Dan’s death, but in a system of clinical research that has been thoroughly co-opted by market forces, so that many studies have become little more than covert instruments for promoting drugs. The study in which Dan died starkly illustrates the hazards of market-driven research and the inadequacy of our current oversight system to detect them.”

Those hazards include questionable informed consent (is a young man who’s experiencing psychotic episodes competent to give his consent?) and financial conflicts of interest. According to Elliott, the U of M psychiatry department earned $15,648 for each person it enrolled in the Seroquel study. In addition, the study’s two U of M investigators, Drs. Charles S. Schulz and Stephen C. Olson, personally earned a combined $811,045 between 2002 and 2008 from Big Pharma, including $261,364 from AstraZeneca, the maker of Seroquel.

At the time Markingson entered the Seroquel study, reports Elliott, the investigators were having serious problems recruiting subjects. Did that factor lead them to enroll someone into the study who shouldn’t have been?

“Even by the standards of a fairly ugly history [of clinical drug trials with ethical breaches] in medical history — even by those standards, this [case] jumps up,” Elliott told me in an interview last week. “There were so many things that went wrong — the consent process, the commitment order under which [Markingson] was recruited into the trial, the financial incentives of the university, the financial incentives of the investigators, and the sheer worthlessness of the trial. Anyone who looked into this and knew anything about clinical research would say this is terrible.”

Elliott sees the trial’s worthlessness as a particularly abhorrent part of the story. The Seroquel study was designed as a marketing tool, he suggests, not as a true scientific inquiry. Such studies, he writes, present a huge ethical problem that isn’t being properly addressed by the oversight systems currently in place:

What is simply assumed [when bioethicists and regulators debate the risks of a clinical trial], without much consideration at all, is that the research is being conducted to produce scientific knowledge. This assumption is codified in a number of foundational ethics documents, such as the Nuremberg Code, which was instituted following Nazi experiments on concentration camp victims. … But what if a research study is not really aimed at producing genuine scientific knowledge at all? The documents emerging in litigation [involving various prescription drugs] suggest that pharmaceutical companies are designing, analyzing, and publishing trials primarily as a way of positioning their drugs in the marketplace. This raises a question unconsidered in any current code of research ethics. How much risk to human subjects is justified in a study whose principal aim is to “generative commercially attractive messages”?

Or, as Elliott told me: “I don’t think anybody who enrolls in a clinical trial thinks, “I know this study is risky, but I think it’s worth it to help Pfizer or AstraZeneca market their drug.”

Read the rest of this article here:  http://www.minnpost.com/healthblog/2010/08/20/20742/disturbing_suicide_tale_u_of_m_professor_reexamines_ethics_questions_of_drug_trial

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National Alliance on Mental Illness (NAMI) – A Pharma front group

Thursday, October 22nd, 2009

The Citizens Commission on Human Rights (CCHR) states it is no wonder that the National Alliance on Mental Illness (NAMI), a group that claims to be an advocacy organization for people with “mental illness,” opposed the black box warnings on antidepressants causing suicide for under 18 year olds in 2004, and black box warnings on ADHD drugs causing heart attack, stroke and sudden death in children in 2006, when you look at their biggest source of funding: Pharma.

Today’s New York Times article, “Drug Makers Are Advocacy Group’s Biggest Donors” states “A majority of the donations made to the National Alliance on Mental Illness, one of the nation’s most influential disease advocacy groups, have come from drug makers in recent years, according to Congressional investigators. The alliance, known as NAMI, has long been criticized for coordinating some of its lobbying efforts with drug makers and for pushing legislation that also benefits industry. Last spring, Senator Charles E. Grassley, Republican of Iowa, sent letters to the alliance and about a dozen other influential disease and patient advocacy organizations asking about their ties to drug and device makers. The request was part of his investigation into the drug industry’s influence on the practice of medicine.

The mental health alliance, which is hugely influential in many state capitols, has refused for years to disclose specifics of its fund-raising, saying the details were private. But according to investigators in Mr. Grassley’s office and documents obtained by The New York Times, drug makers from 2006 to 2008 contributed nearly $23 million to the alliance, about three-quarters of its donations.”

Read NY Times article here: http://www.nytimes.com/2009/10/22/health/22nami.html?_r=2

More on NAMI:

    • NAMI’s pharmaceutical funding was first exposed in the November 1999  Mother Jones article  “An influential mental health nonprofit finds its grassroots funded by Pharmaceutical millions,”  Internal documents obtained by Mother Jones found 18 drug firms gave NAMI a total of $11.72 million between 1996 and mid-1999. These include Janssen ($2.08 million), Novartis ($1.87 million), Pfizer ($1.3 million), Abbott Laboratories ($1.24 million), Wyeth-Ayerst Pharmaceuticals ($658,000), and Bristol-Myers Squibb ($613,505).  And that NAMI’s leading donor was Eli Lilly and Company, maker of Prozac, which gave $2.87 million during that period. In 1999 alone, Lilly will have delivered $1.1 million in quarterly installments, with the lion’s share going to help fund NAMI’s ‘Campaign to End Discrimination’ against the mentally ill.”

    • In a 2000 Insight Magazine article, NAMI spokesperson Bob Carolla stated, “Mental illness is a biologically based brain disorder” and deferred to the U.S. Surgeon General’s 1999 Report on Mental Health as evidence of this. Yet the author of the article, Kelly Patricia O’Meara reviewed the entire report looking for this evidence, and found, “The Surgeon General’s report does not provide a single piece of scientific data supporting mental illness as a brain disorder or disease.”

    Factually, the Surgeon General’s report admitted there is no medical proof to substantiate NAMI’s claims. The report states, “The diagnoses of mental disorders is often believed to be more difficult than diagnoses of somatic or general medical disorders since there is no definitive lesion, laboratory test or abnormality in brain tissue that can identify the illness.”

    Psychiatrist Loren Mosher, former Chief of Schizophrenic Research Studies National Institute of Mental Health (NIMH) stated, “The National Alliance for the Mentally Ill (NAMI) gets the pharmaceutical money and then says they spend it on their ‘antistigma’ campaign. They say that mental illness is a ‘brain disease.’ And it works well for the people who suffer from this to use their drugs. This is why NAMI is pushing for forced medication. It is an amazing selling job on the part of NAMI.”

    • December 18, 2003, The New York Times reported that NAMI bused scores of protestors to a hearing in Frankfort, Kentucky, took out full page ads in Kentucky newspapers, and sent angry faxes to state officials, all protesting a state panel proposal to exclude the antipsychotic drug Zyprexa from Medicaid’s list of preferred medications. According to the article, “What the advocacy groups did not say at the time was that the buses, ads and faxes were all paid for” by the manufacturer of the antipsychotic drug Zyprexa, Eli Lilly.

    In 2004, NAMI opposed the FDA issuing “black box” warnings on antidepressants about their increased risk of suicidal thoughts and behaviors in under 18-year-olds.

    In 2006, despite overwhelming evidence of serious adverse cardiac events and sudden deaths caused by ADHD drugs, NAMI took the position that the “black box” warning on ADHD drugs was “premature.”

If NAMI was truly a patient’s rights advocacy group as they purport to be, the question must be asked why they opposed legislation that forwards patients rights.

Take for example the Child Medication Safety Act, a bill that passed the House of Representatives 425-1 in 2003. The bill stated that as a condition of receiving federal funds, states develop policies and procedures that prohibit schools from requiring a child to take psychiatric drugs as a condition of attending school. NAMI reported in their Policy Alerts section of their Beginnings newsletter that summer that they were “not opposed to the intent of the bill.” However, in the same article they stated “given the bill’s stern enforcement provisions—threatening the loss of federal education funds—it’s enactment would inevitably have a chilling effect on schools across the country.” They went on to encourage people contact their Senators to “express concern” about the bill.

Despite NAMI’s efforts, the bill, hailed as a protection for parents rights, was passed in December 2004 as the Prohibition on Mandatory Medication Amendment, a bill CCHR and many other concerned groups had been strongly in support of, after numerous parents came forth stating they had been forced to have their children take psychiatric drugs as a condition of attending school, and even had been charged with medical neglect for failing to comply.

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