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The Heparin DisasterA running commentary on the contaminated heparin disaster caused by Baxter Healthcare's distribution of contaminated heparin from Scientific Protein Lab's API, and the deaths and injuries resulting therefrom.Wednesday, April 29, 2009 Baxter Releases Live Avian Flu VirusBaxter International, the company that brought us contaminated Chinese heparin, has struck again. The The World Health Organization is closely monitoring the situation. The contaminated product was a mix of H3N2 seasonal flu viruses and unlabelled H5N1 live avian flu viruses. The viruses could have combined to create an even more dangerous hybrid.
Amazingly, Baxter refused to reveal information about how the accident happened because of fear of revealing “trade secrets.” According to the
Labels: Baxter, Baxter Heparin, Chinese heparin, Heparin, heparin lawsuit, heparin lawyer
Monday, April 27, 2009 Grassley, Kennedy Introduce Bill to Protect Against Contaminated Imported DrugsSens. Chuck Grassley (R-Iowa) and Edward Kennedy (D-Mass.) introduced new legislation in Congress last week that would broaden the FDA’s inspection and enforcement authority with respect to foreign drugs and medical devices. To view the press release on the proposed legislation, click here. This legislation, referred to as “The Drug and Device Accountability Act of 2009,” would give the FDA money to conduct foreign drug plant inspections. As stated by Sen. Grassley, “An increasing number of drugs and ingredients for pharmaceuticals are being manufactured in other countries, yet studies show the FDA doesn’t know how many foreign plants are subject to inspection, and the FDA conducts relatively few foreign inspections each year. Our legislation is a practical solution to beefing up the FDA’s inspection work, both domestically and abroad, and holding the FDA accountable for its review of medical devices, where questions have been raised about the agency’s work.” The proposed legislation would also give the FDA the power to detain products from foreign plants when inspectors believe that a drug, (such as the dirty Chinese heparin that recently killed hundreds of Americans), has been adulterated. This is important because the FDA currently has no alternative, but to rely on the overworked and unfunded U.S. Customs to handle the actual seizure of suspect imported goods. The bill would also give the FDA the power to issue subpoenas allowing the agency to obtain internal business records from careless drug manufacturers who ship production of their drugs overseas in order to increase corporate profit and avoid regulation meant to protect the American public. As discussed previously in our May 21, 2008 blog, “FDA Needs Subpoena Power,” without this ability, the agency is powerless to obtain internal business records from a negligent company who has allowed contaminated drugs to be sold, (such as Baxter who sold the dirty Chinese heparin from a foreign plant that Baxter knew had never been inspected by the FDA or any other governmental agency). The FDA is one of the few Federal agencies that currently lacks subpoena power. As previously noted by Rep. Bart Stupak, (Chairman of the investigations panel of the House Commerce Committee), in a letter last year to the former FDA Chief, “An integral part of ensuring the FDA can protect the American people is equipping the Agency with proper resources and enforcement authority it currently lacks….In some cases, the FDA does no testing of its own, and in making decisions it must rely entirely on the test results submitted by manufacturers. Without subpoena power, the only way the FDA can ensure it has the information it needs it to threaten criminal prosecution by the Justice Department if it finds critical data is withheld.” Finally, the proposed legislation would also require certification of applications for drugs and devices needing FDA approval and establish civil and criminal penalties for false or misleading certifications. To fund the new powers, the bill would levy fees on plant inspections, thus putting the cost on the drug manufacturers who decide to send production overseas. This regulation would likely have prevented the Heparin debacle and saved the lives of hundreds of innocent Americans. As such, we commend and support this important legislation. Labels: Baxter, Baxter Heparin, China, Chinese, Chinese heparin, FDA, Grassley, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, Kennedy, OSCS, Stupak
Thursday, April 23, 2009 Sherrod Brown speaks out for Heparin Victims
Ohio Senator Sherrod Brown struck a blow for victims of dirty Chinese Heparin yesterday in a speech in our nation's capital. Speaking before the Washington International Trade Association and the George Washington University Elliot School for International Relations, Senator Brown decried the importation of cheap drugs:
Our enormous trade deficit has resulted in our nation not only importing goods and services, but also importing the dangerous safety standards of our trading partners. I discussed the Heparin Disaster with Senator Brown last year in Toledo. He clearly heard the concerns of the victims of big pharma. Senator Brown understands that the big corporations like Baxter Healthcare put profits over people. We have now received about one million pages of documents from Baxter. These documents show that Baxter went to China for its heparin because it could save a few dollars on its raw material costs. Baxter knew the Chinese facility had never been inspected by the FDA. It knew that there were no inspections being performed on the heparin workshops and consolidators. Baxter showed reckless indifference even after the contamination was brought to light. We are now learning that Baxter was being criticized by the FDA in September of 2008 for an inadequate recall. The more we learn, the worse the story. We will continue to uncover the unsavory details and fight in the courtroom for the victims. We ask you to all support Senator Brown as he fights for us in the halls of Congress. Labels: Baxter, FDA, Heparin, Heparin Class Action, heparin lawsuit, Sherrod Brown
Sunday, April 19, 2009 Two Chinese Heparin Suppliers Cited by FDA
The FDA just cited two Chinese-based drug suppliers, Qingdao Jiulong Biopharmaceuticals Co. and Shanghai No. 1 Biochemical & Pharmaceutical Co, who manufactured and sold at least 19 lots of contaminated heparin to the U.S. in 2008, despite the fact that the heparin was supposed to be quarantined. (See 04/18/09 Wall Street Journal Article, “FDA Cites Two Chinese Heparin Makers.”) To read the FDA’s letter to Qingdao click here. To read the FDA’s letter to Shanghai No. 1 click here.
The heparin was tainted with over-sulfated chondroitin sulfate (“OSCS”), the same contaminate that has been linked with numerous U.S. deaths. During the FDA’s inspection of these companies, the FDA found “significant deviations from U.S. current good manufacturing practices (CGMP) requirements in the manufacture of drugs.” Further, one of the drug suppliers, Shanghai No. I Biochemical, was also was found to have lied to the FDA about the manufacture of its heparin. Specifically, the FDA found that the Chinese drug supplier “used two other manufacturers to produce heparin sodium, failed to notify FDA of this manufacturing arrangement, and affirmatively represented that ‘no contract firms are involved in the manufacturing of the drug substance, Heparin Sodium USP, that is the subject of th[e] Drug Master File.’” Labels: Baxter, Baxter Heparin, FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawsuit, heparin lawyer, OSCS, over sulfated chondroitin sulfate
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