Healthy Skepticism Library item: 5399

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Publication type: media release

McCall R.
Media Advisory - Congressional Members Join Victims Harmed by Prescription Drugs to Protest FDA's Safety Record on Eve of its 100th Anniversary
Baum Hedlund 2006 Jun 28

Full text:

June 28, 2006
FOR IMMEDIATE RELEASE

Baum Hedlund
12100 Wilshire Blvd., Ste. 950
Los Angeles, CA 90025
Contact: Robin McCall, Media Relations
Day: (800) 827-0087 or (310) 207-3233
Email: RMcCall@BaumHedlundLaw.com
Web: www.baumhedlundlaw.com

Congressional Members Join Victims Harmed by Prescription Drugs to Protest FDA’s Safety Record on Eve of its 100th Anniversary

Washington, D.C. – - June 30, 2006 marks the Food and Drug Administration’s (FDA’s) 100th anniversary. In its press announcement, FDA boasts that it is the “oldest U.S. consumer protection office” providing “Americans with increasingly comprehensive, science-based protections that ensure the highest quality of products essential for health and survival.” http://www.fda.gov/bbs/topics/NEWS/2006/NEW01292.html

Capitol Hill Press Conference – June 29, 2006, 12:30 PM Room 121 of the Cannon House Office Building

Victims of prescription drug-induced injuries disagree with the FDA’s characterization of itself and will gather on Capitol Hill, along with Consumer’s Union (publisher of Consumer Reports) on Thursday, June 29, 2006 to address FDA’s drug safety failures and to urge Congress to pass stalled drug safety measures such as the public registry of drug trials; post-market safety monitoring and enforcement; and limiting new drug advertising and marketing. (See Consumer’s Union: Prescription for Change Media Advisory, attached.) Congressional Representatives from Connecticut, Minnesota, New York and Massachusetts will join Consumer’s Union and the victims at a 12:30 p.m. press conference in Room 121 of the Cannon House Office Building.

Baum Hedlund client, Kim Witczak, to attend

Prescription Drug safety activist, Kim Witczak, whose husband committed suicide while taking an SSRI antidepressant, is one of the victims who will be telling her story in order to illustrate the real consequences of the FDA’s failures and how devastating these failures can be. Her story was featured in the November 2005 issue of Fortune Magazine and was covered in an I-Team feature on WCCO TV in Minneapolis. She has been on NPR regarding drug advertising and has been quoted in a number of news reports on drug safety issues. Ms. Witczak has a website devoted to her husband’s memory and raising awareness about the risks of antidepressants and related drug-safety issues: www.woodymatters.com.

Public Opinion Poll Shows Lack of Confidence in FDA

Kim and other victim-advocates are not alone in their opinions regarding the FDA’s public safety failures. According to a May 2006 public opinion poll conducted by the Wall Street Journal and Harris Interactive, “the majority of U.S. adults think the U.S. Food and Drug Administration’s (FDA) most important function is to ensure the safety and efficacy of new prescription drugs. However, over the past two years, the public has become increasingly skeptical about the agency’s ability to meet that mission, with seven in 10 adults giving the FDA a negative rating. A vast majority of adults are concerned about the agency’s ability to make independent decisions that will ensure public access to safe and effective drugs. In addition, large majorities across party lines say the FDA’s decisions are influenced by politics rather than medical science.” See: http://www.harrisinteractive.com/news/allnewsbydate.asp?NewsID=1060

FDA’s “Final Rule” goes into Effect June 30, 2006

Ironically, June 30th also marks the day on which the FDA’s “Final Rule” goes into effect. The “Final Rule” sets forth new requirements for prescription drug labeling. What is significant about the “Final Rule” is that FDA lawyers inserted into the preamble section (which is not legally binding), a decidedly anti-consumer position. The FDA states that once a drug has been approved by the FDA, American consumers should not be permitted to second guess the FDA’s decision by suing drug companies for the injuries their drugs have caused (even if the drug company hid its knowledge of the side effects from both the public and FDA).

Judge Criticizes FDA’s Preemption Position

The FDA’s position was sharply criticized recently by a New Jersey state court judge, the Honorable Carol E. Higbee. During a June 6, 2006 hearing, she called the Final Rule’s preamble “a political statement by the FDA.” She complained that the FDA’s position that lawsuits should be federally preempted and that the FDA should be the final word has “nothing to do with science. … It is contrary to the U.S. Supreme Court’s decisions. It is contrary to all the law on preemption. … In addition to being contrary to the law of the land, it is also contrary to the Constitution of the United States.” She concluded by telling the defendant’s in the case: “And I am not going to allow you to use it.” Doherty v. Merck & Co., Ind., Docket No. ATL-L-0638-05MT, in Superior Court of New Jersey, Atlantic County Civil Division. (For more information on preemption, see: http://www.baumhedlundlaw.com/AttorneyArticles/KarenBarthMenzies/PreambleToFDAFinalRule.pdf

GAO Finds Fault with FDA

The FDA’s centennial anniversary also follows a highly critical report by the Government Accountability Office (GAO) which found the FDA’s performance “disorganized,” “bureaucratic,” and undermined by infighting between drug evaluation administrators whose allegiance is with industry, and the Office of Drug Safety. The GAO also criticized the way the FDA’s safety experts were prevented from speaking at important advisory committee meetings on drugs they were studying. The GAO report pointed out that “day-to-day oversight of safety issues is still hampered by poor information, lack of legal authority to order drug company studies, and bickering between the powerful FDA bureau that reviews drugs for approval and a smaller safety office depicted in the report as a bureaucratic stepchild,” the LA Times reported. The FDA “has not effectively overseen post-market drug-safety issues, and as a result, it is unclear how [the agency] can know that important safety concerns have been addressed and resolved in a timely manner,” the report said. See: http://www.latimes.com/news/nationworld/nation/la-na-fda24apr24,0,1424816.story?coll=la-home-headlines

Prescription Drug Deaths and Injuries

Since the year 2000, ten drugs have been withdrawn from the market due to safety concerns. Two million people are injured annually from prescribed pharmaceuticals—106,000 die from adverse prescription drug effects—in addition to 98,000 drug related deaths in hospitals due to errors. See: www.ahrp.org/cms/content/view/148/28 and Langreth, R. Just Say No, FORBES Nov. 29, 2004 http://www.forbes.com/forbes/2004/1129/102_print.html.

Statement by Karen Barth Menzies (Award Winning Pharmaceutical Drug Product Liability Attorney and Victims’ Advocate) on FDA’s 100th Anniversary

According to Karen Barth Menzies, “The FDA should not be congratulating itself in the wake of prescription drug safety failures over the past decade or so. How many innocent people, including children, have become statistics because the FDA failed them? I hope the legacy of the FDA in another hundred years from now is one of effective and unbiased oversight with an emphasis on encouraging new and innovative cures for real diseases, rather than rubber-stamping ‘me too’ drugs so that each company can have its own ‘blockbuster.’”

http://www.baumhedlundlaw.com/attorneys/karenbarthmenzies.htm

Robin McCall
Director of Media Relations
Baum Hedlund
RMcCall@BaumHedlundLaw.com