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Tuesday, July 31, 2007

FDA Panel Weighs in on Avandia

Yesterday, Dr. David Graham of the FDA recommended to a panel of scientific advisors the diabetes drug Avandia be pulled from the market. Studies have shown the drug may lead to an increased risk of heart attacks.

In a 20-3 vote, the panel agreed the drug increases the risk of heart attacks, according to The New York Times.

But the panel did not concur with Graham's assessment. The panel voted 22 to 1 to leave the drug on the market. Instead, the panel recommended the drug's packaging include warnings of the potential side effects. FDA will make the final decision on the drug's fate and may or may not choose to adopt the panel's recommendations.

On a related note, NPR reported a good story this morning on post-market drug safety. Dr. Bruce Psaty of the University of Washington describes how FDA and drug makers monitor the safety of drugs after they are approved for consumer use and why these processes are often insufficient. Listen to it here.



Posted by Matt Madia, 09:56:14 AM



Monday, July 30, 2007

Science-based Policy Not Bush's Cup of Tea

Former Surgeon General Richard Carmona's claim that senior Bush administration officials interfered with his work has caused quite the controversy. Now, more information is surfacing as to the exact incidences of manipulation.

A report titled, "Call to Action on Global Health" was commissioned by Carmona but never published. According to The Washington Post, "Three people directly involved in its preparation said its publication was blocked by William R. Steiger, a specialist in education and a scholar of Latin American history whose family has long ties to President Bush and Vice President Cheney."

The report doesn't espouse any revolutionary ideas. According to the Post, it identifies the link between poverty and public health, calls for citizens and corporations to take action to improve health conditions, and recommends America make the issue of global health a primary aspect of its foreign policy.

Of course, none of these findings jibes with the ideas of President Bush. This White House has been loath to address poverty and inequality issues and would never ask Americans or American corporations to sacrifice in the name of a greater good. (Maybe if the report told Americans to improve global health conditions by going to the mall it wouldn't have been tampered with.)

You wouldn't expect a surgeon general report to immediately change the way individuals, businesses and government operate. Rather, documents like this are about science-based policy ideas. Unfortunately, higher-ups in the Bush administration foolishly think they already have all the ideas America could ever need.



Posted by Matt Madia, 05:29:59 PM



Expert Urges FDA to Pull Diabetes Drug from Market

An FDA scientist has recommended the diabetes drug Avandia be pulled from the market for heightening heart attack risks associated with its use. Dr. David Graham made the recommendation during a meeting of a scientific advisory panel which will consider whether the drug should continue to carry FDA approval, according to the Associated Press.

In May, a study published in the New England Journal of Medicine called attention to heart problems associated with the drug.

The FDA could have prevented this scandal by listening to doctors and scientists who recommended a "black-box" warning on the drug's label, the highest the FDA imposes, in February 2006. Instead, the FDA chose to alienate its own experts from the process, siding with industry-backed data.

Unfortunately, patients who have taken Avandia bear the true cost of regulators' irresponsibility. GlaxoSmithKline is questioning the validity of FDA data with its own, also according to AP. Let's hope that this time FDA stands up for public health.



Posted by Kyle Hatzes, 11:52:12 AM



Wednesday, July 25, 2007

Progress in the FDA? Think again.

You'd think that U.S. Food and Drug Administration (FDA) officials would be willing to listen to their own employees as public confidence in the agency diminishes among a string of regulatory lapses and congressional investigations. However, a BNA report ($) suggests otherwise.

Last week, members from the House Energy and Commerce Committee met with a panel of FDA employees from several district offices to discuss the effectiveness of the agency in keeping Americans safe. At one point, the panel rated the effectiveness of the FDA between 2 to 5, on a scale of 1 to 10 (highest), though they refuted claims that FDA personnel in the field and in the offices were to blame and defended the agency's expertise.

In what is considered a retaliatory move, Assistant FDA Commissioner for Regulatory Affairs Margaret Glavin sent an officewide e-mail claiming that their peers had balked at the performance of FDA personnel. FDA Commissioner Andrew von Eschenbach defended FDA's food safety work but didn't condone Glavin's intimidation in an agency-wide e-mail the same day. According to the report's sources, however, it appears that Glavin grossly misrepresented the intentions of the panel.

Accountability seems to mean little to FDA officials these days. The lack of initiative by top agency officials to confront the issues that face the agency everyday shows a disregard for life-protecting regulation.

More disappointingly, von Eschenbach may have missed his golden opportunity to show true responsiveness to the concerns of his employees, and the welfare of the general public, by listening to the panel and using their testimonies constructively to help improve the agency's effectiveness and rebuild the FDA's tarnished image.



Posted by Rick Melberth, 05:36:27 PM



Victims of High Dioxin Exposure Levels Left Behind

Residents of Mossville, LA, have three times the level of dioxin in their blood as the national average, and 90 percent of the residents have illnesses that are linked to dioxin exposure. These are conclusions drawn from government data, so the humane, responsible thing for government agencies to do is — nothing.

According to a BNA story ($), the data were collected by the Agency for Toxic Substances and Disease Registry (ATSDR), the U.S. Environmental Protection Agency and the Louisiana Department of Environmental Quality. ATSDR's investigation of the exposure has been underway since 1998. But according to a report, Industrial Sources of Dioxin Poisoning in Mossville, Louisiana: A Report Based on the Government's Own Data, just released by Advocates for Environmental Human Rights (AEHR), "However, the Exposure Investigation entirely fails to identify the sources of the dioxins harming the health and environment of residents."

Mossville, an African American community, is surrounded by 14 toxic industrial facilities including vinyl manufacturers, oil refineries, coal-based power plants and chemical plants. The report, authored by AEHR and others, identifies six facilities as the culprits. Yet no assistance to the residents or other remedial action by the responsible government agencies has taken place.



Posted by Rick Melberth, 02:49:20 PM




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