Archive for November, 2008

FDA may have mishandled the Heparin scandal

Wednesday, November 26th, 2008

Questions are being raised as to the adequacy of the Food and Drug Administration’s handling of the contaminated blood thinner Heparin earlier this year. It is thought that the FDA misreported deaths tied to the product and didn’t thoroughly investigate the problem. It appears that the FDA released conflicting statements to the public and Congress about the number of deaths tied to contaminated Heparin.

The FDA said it linked three deaths to the defective drug in May, but last month claimed that only two of the deaths were possibly linked to Heparin when reporting to congressional staff.

Baxter International Inc., a company involved in the scandal, did its own investigation of the deaths and concluded that Heparin was not the likely cause in the three cases. Their investigation included obtaining medical records from patients, visiting a hospital where one of the patients had gone before dying, and interviewing pharmacists and nurses.

The FDA didn’t follow up with a clinical staff at the hospitals, talk with Baxter to find out further information about deaths, or access other medical databases it uses to evaluate drug safety problems.

Beware of milk imported from China

Wednesday, November 26th, 2008

In the past month, the FDA has issued an import alert detaining ALL milk products, milk derived ingredients and finished food products containing milk from China due to the presence of melamine.

These foods include both human foods (bakery products, cereals, cheese, ice cream, soft drinks, and candy) as well as several types of pet foods (pet cat foods, pet dog foods, pet fish foods, other pet foods, laboratory animal feeds, pet and laboratory animal foods, byproducts for animals, dairy byproducts for animals, and animal waste feed products) imported from China.

According to the FDA, the melamine milk contamination started in infant formula but “these contaminated milk components appear to have been dispersed throughout the Chinese food supply chain…Reports of contamination have come from more than thirteen countries in Asia, Europe, and Australia, in addition to the United States.”

Time magazine has reported that the Chinese government continues to downgrade the severity of the problem. Some believe that the contaminated foods are “one of the most important factors resulting in the soaring number of birth defects in China.”

FDA corrupted safety process

Wednesday, November 19th, 2008

According to a report published on Bloomberg.com, scientists and physicians at the Food & Drug Administration (FDA) have charged that the agency has corrupted the process by which new medical devices are approved.

The names of scientists who made the charges, as well as the devices to which they refer, have been redacted in the copy of a letter released to the public.

But the allegations in the letter are troubling. The scientists charge that misconduct by managers at the FDA Center for Devices and Radiological Health (CDRH) “is interfering with our responsibility to ensure the safety and effectiveness of medical devices for the American public and with FDA’s mission to protect and promote the health of all Americans.”

The letter was sent to members of the House Energy and Commerce Committee, the Congressional arm that provides oversight of the FDA.