Community forums, scientists criticize FDA

March 5, 2012

Health, Political

The need to “fix the FDA” tops the list for government reforms, according to an unusual community forum in Tempe, Ariz., moderated by Dr. Martha Grout. Some 250 people gathered at the Southwest Institute of Healing Arts (SWIHA) on December 28, 2008, to discuss health care reform. The meeting was in response to the Obama administration’s offer to hold grass-roots meetings around the country on health care reform and its request for those results to be forwarded to www.change.org.

Attendees said that, time and again, the federal Food and Drug Administration has failed to protect the public, and that it has become a tool of the pharmaceutical industry. Many attendees expressed the belief that because food is medicine, we also must reform commercial agricultural practices to create nutrient-dense food, free of pesticides and genetic modification. Many also think that school lunch programs need to provide a learning environment where children are taught what good nutrition is and how that relates to health.

“Looking at the big picture, people were saying we must move away from the disease-management paradigm of medicine that dictates health care today in the United States,” said Mary Budinger, coordinator of the event. “Attendees were unanimous that there is far too little emphasis on prevention and preventive medicine. I noticed in the materials we received from the Obama administration, [that] their examples of prevention were annual flu shots, annual mammography screenings and regular cholesterol checks. To many of us, that adds up to a dose of mercury, a blast of radiation and an invitation to use statin drugs. That is not good preventive health care. None of that will reduce the cost of health care.”

The December meeting was a unique gathering of people from across the complementary and alternative health care spectrum — doctors, dentists, massage therapists, homeopaths, acupuncturists, energy healers and others. There was a groundswell of feeling that the Complementary Alternative Medicine (CAM) community should work together to reform the medical paradigm — to emphasize creating a healthy population. “I heard people in this city, years ago, say we need to work together, but nothing came of it because it was like herding cats,” said Joanne Tedesco, editor of AZ Net News. “I hope we are seeing new momentum to create a unified voice. How can we change the paradigm, given the competitive nature of allopathic medicine, if those of us in alternative medicine don’t have a united front?”

Other ideas tossed up by attendees included freedom to choose vaccinations, freedom to choose a wide variety of health care, the ability to know what chemicals are in the environment, a ban on television ads for prescription drugs, the ability to have treatments which are available in Europe approved in the United States, and getting the allopathic community to understand energy medicine — both the healing potential, and the unhealthy exposure to electro-magnetic fields from cell phones, computers and the like. Complete results of the meeting can be read at www.arizonaadvancedmedicine.com/health_care_discussion1.html.

On January 7, 2009, nine FDA scientists sent an unusually blunt letter to the Obama administration outlining widespread managerial misconduct in a division of the FDA that evaluates medical devices, ranging from stents and breast implants to MRIs and other imaging machinery.

“The scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk,” the scientists wrote in the letter. The concerns echo some of the complaints from the FDA’s drug review division a few years ago during the safety debacle involving the painkiller Vioxx.

Written on letterhead from the agency’s Center for Devices and Radiological Health, the group claims that managers use intimidation to squelch scientific debate, leading to the approval of medical devices for which the effectiveness is questionable and which may not be entirely safe. “Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid,” the letter stated.

The FDA declined to publicly respond to the letter, but said it is working to address the concerns.

Lawmakers on both sides of the aisle are urging President Obama to appoint a commissioner who will shake up the FDA, and restore the confidence of its working-level scientists and medical experts.

 

Reprinted from AzNetNews, Volume 28, Number 1, Feb/Mar 2009.

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