2/3 Institute of Medicine AIDS research panel have Conflicts of Interst – Assoc Press

2/3 Institute of Medicine AIDS research panel have Conflicts of Interst – Assoc Press

Thu, 17 Mar 2005

On Feb 25, the New York Times reported that 10 of 32 FDA panelists determining whether to recommend that COX 2 painkillers should allowed to be marketed despite the documented increased risk of heart attacks and strokes, had financial conflicts of interest. (The number of such conflicted panelists was later reported to be 27 out 32). See: http://www.ahrp.org/infomail/05/02/25.php
http://www.ahrp.org/infomail/05/03/01.php

An investigation by The Los Angeles Times uncovered documents showing that at least 500 of NIH senior researchers not only had financial conflicts of interest–but they failed to report their deals with biotech and drug companies.

See latest in the series: http://www.ahrp.org/infomail/05/03/05a.php

Yesterday, the Associated Press reported that two-thirds of a panel of experts appointed by the Institute of Medicine, to investigate a controversial AIDS study conducted in Uganda with funds from NIH, receive grants from NIH.

The experiment involves nevirapine, a controversial AIDS drug. President Bush allocated $500 million offering nevirapine to African nations a “cheap solution” for protecting African babies from AIDS without being informed by NIH officials that the drug had in fact been found to cause “thousands of severe reactions including deaths.”

That information was revealed by an NIH whistleblower, Dr. Jonathan Fishbein, who was hired to ensure that NIH-funded AIDS research complies with ethical and scientific standards. See:
http://www.ahrp.org/infomail/04/12/13a.php ;
http://www.ahrp.org/infomail/04/12/14.php ;
http://www.ahrp.org/infomail/04/12/15b.php

Yesterday’s report by the Associated Press (below) sheds light on the Institute of Medicine (IOM) and its members’ conflicts of interest. The IOM has, until now, maintained a carefully cultivated image as an independent source of reliable, science-based expert opinions on matters affecting health care policies. Indeed, Congress and the public have assumed that pronouncements by the IOM are impartial and evidence-based. But that assumption is belied by the facts.

Critics point out that the IOM is hardly free from conflicts of interest and that their pronouncements more often than not favor pharmaceutical company interests. Most IOM members-physicians and bioethicists-are employees of major medical schools that have extensive financial ties to pharmaceutical and biotech companies. Additionally, IOM members include executives at major pharmaceutical companies. IOM members receive millions of dollars in grants from both industry and NIH. Their financial interests present personal and institutional conflicts of interest–raising doubts about IOM members’ ability to render an objective evaluation about controversial drugs, vaccines, and other issues affecting health care.

Two recent examples illustrate that IOM panels tend to issue pronouncements that favor industry interests and government policies that have been adopted under the influence of industry. An IOM panel gave a clean bill of health to two highly controversial vaccines which critics charge disregarded a body of scientific evidence showing the vaccines caused some of those vaccinated, irreparable harm.

The controversial infant vaccines-Measles / Mumps / Rubella (MMR) are laced with high levels of thimerosal (mercury). Thousands of parents have charged that the mercury in the vaccines cause autism in their children. Although mercury is known to cause neurological damage, drug manufacturers– Eli Lilly, Merck–have denied a link. Even without complete data, the IOM issued a “final” report (2004), Immunization Safety Review: Vaccines and Autism, upholding the manufacturers’ claim that no causal link has been proven between the vaccine and autism. Critics point out that the IOM panel failed to analyze the body of evidence showing that at the high doses that American infants are exposed to mercury, the risk is demonstrable.

Another IOM panel exonerated the equally controversial experimental anthrax vaccine whose safety has not been proven. Military personnel have been forced to take the anthrax vaccine without informed consent. A federal judge ordered the government to suspend its forced anthrax vaccination program in October, 2004. See: http://www.dcd.uscourts.gov/03-707c.pdf

IOM pronouncements such as these give vaccine manufacturers the benefit of the doubt, when a precautionary approach would be consistent with good medicine-especially when there are serious consequences affecting life safety. The absence of accountability on the part of advisory panels such as the IOM ensures that decisions are not fully justified by the evidence. The predictable, though unintended, consequences endanger lives.

How can the public trust the integrity of medical recommendations if the researchers, the providers and all agents involved in formulating health care policies are individually and /or institutionally intertwined with the pharmaceutical industry?

Congressman Dave Weldon noted that the IOM MMR vaccine report “is premature, perhaps perilously reliant on epidemiology, based on preliminary incomplete information, and may ultimately be repudiated.” He reminded the IOM that it “is not immune to error and has been forced to reverse itself before, most recently reversing a long-standing finding that chronic lymphocytic leukemia (CLL) was not due to Agent Orange exposures. A similar reversal is a very real possibility here.”

See: http://www.vaccinetruth.org/congressman_dave_weldon.htm

Senator Charles Grassley, chairman of the Senate Finance Committee, said he is concerned the current IOM panelists’ financial ties to NIH create a conflict of interest that sullies any conclusions they make.

“If there’s financial interest, there’s a conflict, and that’s a factor to consider when sizing up objectivity.”

Contact: Vera Hassner Sharav
212-595-8974

Associated Press
AIDS Panel Gets Money From Agency in Probe
Wed Mar 16, 2:20 AM ET By JOHN SOLOMON,

WASHINGTON – Two-thirds of the members serving on an expert medical panel investigating a U.S.-funded AIDS (news – web sites) study are receiving grant money from the federal agency at the center of the probe, according to documents and interviews.

Yahoo! Health

The Institute of Medicine (news – web sites) said it was aware of the financial ties with six of the nine members of its expert panel but approved their participation because they have special expertise, receive only a minority of their overall funding from the National Institutes of Health (news – web sites) and won their grants competitively.

The six panel members are receiving funds from NIH ranging from $120,000 to nearly $2 million a year, according to agency records and interviews by The Associated Press.

IOM, the nation’s health adviser, believes the panel’s ultimate conclusions about NIH’s controversial AIDS study in Africa won’t affect the members’ NIH funding, and thus there is no conflict of interest, spokeswoman Christine Stencel said.

“When you get into some of these fields or areas, you are not talking about a really huge pool of experts who can be candidates or experts,” Stencel said.

“In this case a lot of the great candidates potentially would have had funding from NIH. … Do you keep off of your committee every great expert out there because they can’t have a single penny from NIH or do you strive for a balance, keeping any possible connection like that to an absolute best possible minimum?” she said.

Stencel said IOM rejected two other potential members because they received a majority of their funding from NIH or drug companies tied to AIDS research.

The chairman of the Senate Finance Committee said he is concerned the researchers’ financial ties to NIH create a conflict of interest that sullies any conclusions they make.

“If there’s financial interest, there’s a conflict, and that’s a factor to consider when sizing up objectivity,” Sen. Charles Grassley (news, bio, voting record), R-Iowa, said.

Frequently the government has appointed experts to scientific panels even though they had connections to the issues, companies or agencies they were investigating. For instance, federal drug regulators recently acknowledged that some advisory panel members who recommended pain killers stay on the market had ties to the makers of the drug.

Legal and medical ethicists said IOM likely didn’t violate any laws but should have done more to alert the public to the financial conflicts in the NIH case, especially because the panel members have an ongoing financial relationship with the agency.

“Essentially, what the public will want to know about this report is is this a whitewash or is it actually independent,” said Kathleen Clark, a government ethics expert at Washington University in St. Louis.

“It is interesting that they (IOM) revealed this only in response to an inquiry from Senator Grassley and from the media. That’s problematic,” she said.

IOM’s review of NIH’s study in Uganda of the AIDS drug nevirapine has international implications. The study was relied on by the Bush administration to back its decision in 2002 to send hundreds of millions of dollars worth of nevirapine to Africa to help stop the spread of AIDS from mothers to babies. AP reported in December the study violated federal patient protection rules and suffered widespread problems with paperwork and compliance.

NIH officials acknowledge the problems but say they remain confident in the study’s overall conclusion, that nevirapine can be taken safely in single doses. NIH asked IOM last fall to independently investigate its conduct in that study.

South Africa is deciding whether to end nevirapine’s use for pregnant mothers.

At least four IOM panel members get their money directly from NIH’s infectious disease institute, whose conduct is at the center of the IOM investigation. Two others get their funding from NIH’s Fogarty International Center, which helps fund research worldwide on issues from AIDS to mental health.

Dr. Mark Kline, an IOM panel member and pediatric AIDS expert at Baylor University, said he receives between $250,000 and $300,000 a year from NIH. He said he went into the study “as objectively as possible and in an open-minded manner and tried to judge on the basis of the evidence.”

Kline said NIH money accounts for 5 percent or less of his overall program. “It had never crossed my mind that there would be implications for my funding,” he said. Other IOM panel members with NIH funding:

  • Dr. Wafaa El-Sadr, an AIDS expert at Columbia University, received just over $2 million from NIH’s infectious disease division last year, NIH said.
  • Stephen W. Lagakos, director of Harvard University’s Center for Biostatistics in AIDS Research, which received $242,700 from NIH in the past year, NIH said.
  • J. Richard Landis, a University of Pennsylvania biostatistics expert who received $136,229 in funding from NIH’s infectious disease division last year, NIH said.
  • Dr. Charles van der Horst of the University of North Carolina-Chapel Hill, who helped oversee a multimillion-dollar NIH study on the side effects of AIDS medicines. Last year, his project got more than $120,000 in NIH funding, the agency said.
  • George W. Rutherford of the School of Medicine at the University of California, San Francisco, who receives funding through NIH’s Fogarty Center. NIH and IOM confirmed Rutherford was awarded a five-year grant in 2001 for AIDS training and research. Rutherford said he received $243,308 in the past year.

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On the Net:
Institute of Medicine: http://www.iom.edu
National Institutes of Health: http://www.nih.gov

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