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Profile: Institute of Medicine
Institute of Medicine was a participant or observer in the following events:
An expert panel convened by the National Science Academy’s Institute of Medicine issues a report recommending a number of changes to how the FDA regulates the drug industry. The proposed changes are unanimously endorsed by the panel, comprised of 15 experts from academic and professional organizations. Some of the recommendations include:
The FDA should implement a moratorium on direct consumer advertising of recently approved classes of drugs until enough aggregate data is available to confirm the drugs’ safety. Packaging for such medications should have a special symbol imprinted on them alerting consumers to the higher risk associated with new medications.
The FDA should be required to reevaluate the safety and effectiveness of drugs at least once every five years after the drug has been approved. The agency’s current system for monitoring drug safety post-approval is far less effective than pre-approval testing. The report notes that there is a history of fierce disagreements between the FDA’s Office of Drug Safety and the agency’s Office of New Drugs.
The FDA should be given new powers to impose fines, injunctions, and withdrawals
when drug companies fail to complete the required safety studies.
The agency should be given the authority to impose a wider range of restrictions on drugs it considers potentially unsafe.
The government should require drug companies to register all clinical trials they sponsor in a government-run database so patients and physicians can review all studies. Currently, only those studies published in medical journals are accessible to the public, and these tend to be the studies that produce the most favorable results for the drug being tested.
Expert advisory panels should not be loaded with industry-connected scientists. Most of the members making up these panels should be free of industry ties. “FDA’s credibility is its most crucial asset, and recent concerns about the independence of advisory committee members… have cast a shadow on the trustworthiness of the scientific advice received by the agency,” the report says. [Institute of Medicine, 9/22/2006; Washington Post, 9/23/2006; New York Times, 9/23/2006]
Dr. Jonathan Fishbein. [Source: unknown]Government whistleblower Dr. Jonathan Fishbein, in testimony before a panel at the Institute of Medicine, says that federal officials involved in a US-funded study in Uganda endangered the lives of hundreds of patients testing an AIDS drug because of careless and negligent research practices. Fishbein says officials at the National Institutes of Health (NIH) ignored problems with the way the study was being conducted on the AIDS drug, nevirapine, which is used to protect babies in Africa from HIV infection during birth. The consequences of their failure had “grave and sometimes fatal implications for the lives of real patients,” Fishbein tells the panel. Fishbein does not allege that the drug is dangerous or ineffective. Instead, he discusses problems with the researchers involved, citing shoddy data collection, record-keeping and quality control issues. Because of those concerns, he says, the results of the study cannot be trusted. “We can ill afford to entrust the lives of people to invalid data,” he says. NIH has acknowledged that the Uganda research failed to meet required US standards. But it maintains that hundreds of thousands of African babies have been saved by using single doses of the drug to block the AIDS virus and that it can be done safely with those single doses. Nevirapine is an antiretroviral drug used since the 1990s to treat adult AIDS patients and is known to have potentially lethal side effects like liver damage when taken in multiple doses over time. Concerns have been raised over the possibility that the drug may cause long-term resistance in patients to further AIDS treatments. It is marketed in the United States as Viramune. Fishbein says that top officials at NIH became “so heavily invested in the trial’s outcome” that they could not be objective. “The old adage ‘garbage in, garbage out’ is apt,” he says. In 2003, Fishbein helped halt the study for 15 months after auditors, medical experts, and others disclosed problems with the project. But the concerns were dismissed by NIH officials, and the study began again. Documents show NIH knew of problems with the study in early 2002, but did not tell the White House before President Bush launched a $500 million plan that summer to use nevirapine throughout Africa. NIH is attempting to fire Fishbein for what it calls poor performance issues; Fishbein says the firing is retaliation for his speaking out. [Associated Press, 1/4/2005]
Researchers for Harvard Medical School and the Cambridge Health Alliance release a report that shows approximately 45,000 Americans a year—122 a day or one every 12 minutes—die as a result of a lack of health insurance and a subsequent inability to receive medical care. The study’s co-author, Harvard medicine professor Dr. David Himmelstein, tells a reporter, “We’re losing more Americans every day because of inaction… than drunk driving and homicide combined.” Lead author Dr. Andrew Wilper, a medical professor at the University of Washington, says: “The uninsured have a higher risk of death when compared to the privately insured, even after taking into account socioeconomics, health behaviors, and baseline health. We doctors have many new ways to prevent deaths from hypertension, diabetes, and heart disease—but only if patients can get into our offices and afford their medications.” The study also shows that Americans aged 64 and below have a 40 percent higher risk of death than those who have coverage. The study is published in the online edition of the American Journal of Public Health, and released by Physicians for a National Health Program, which favors government-backed or “single-payer” health insurance. In 1993, a similar study showed those lacking insurance had a 25 percent higher risk of death. In 2002, the Institute of Medicine estimated that around 18,000 Americans a year died because they lacked coverage. Himmelstein says the sharp rise in risk is due to the swelling ranks of the uninsured. Around 46.3 million people in the United States lacked coverage in 2008, according to the US Census Bureau, an increase over the 45.7 million figure from 2007. Another factor is the dwindling resources where the uninsured can receive care. Public hospitals across the country are either denying uninsured people any care at all, or restricting the care they offer. Co-author Dr. Steffie Woolhandler says the findings show that without proper care, uninsured people are more likely to die from complications associated with preventable diseases such as diabetes and heart disease. The National Center for Policy Analysis, a conservative think tank, calls the study flawed; a spokesman for the Center says: “I think you can’t trust the results. Having said that, we ought to do something for the uninsured.” Woolhandler says the study followed similar protocols to those used by earlier government and private studies. “For any doctor… it’s completely a no-brainer that people who can’t get health care are going to die more from the kinds of things that health care is supposed to prevent,” she says. “Historically, every other developed nation has achieved universal health care through some form of nonprofit national health insurance. Our failure to do so means that all Americans pay higher health care costs, and 45,000 pay with their lives.” [Reuters, 9/17/2009; Harvard Science, 9/17/2009; CBS News, 9/17/2009]
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