Lawyer claims his plan to reform the FDA could save 100,000 lives a year, but is ignored by Congress and the White House.
"I have a plan that can save 100,000 American lives and $100 billion in health care costs per year," assures attorney Terence Mix, "but no one in Washington DC will even listen to me." His proposal involves a major remodel of the way drugs are tested prior to marketing and the manner in which the FDA monitors those drugs once they are on the market. Mix, a long-time litigator against drug companies and expert on the pharmaceutical industry, has sent multiple inquiries to the White House, members of the Senate and members of the House of Representatives for the past a year and a half. "I cannot even get an audience with my local congresswoman," he adds.
Every year about 230,000 Americans die as a result of adverse reactions to prescription and nonprescription drugs. It is the third leading cause of death in the United States behind only heart disease and cancer. Mix points out that about 6.5 million people annually incur medical costs for the same reason, including 2.3 million who are hospitalized or have their hospital stays extended. "The cost is huge," he says. "About $200 billion a year - and my plan could easily cut these numbers in half."
Mix points out that with 2.3 lobbyists for every member of Congress and a big check book, the drug industry has considerable influence over both houses and will not sanction a change in the status quo. "I am not naive," he says. "That's one lobbyist for every ear in Congress and a few more to write the checks. But something needs to change. I have had access to thousands of pages of confidential drug company records and am well-acquainted with the close relationship between the FDA and its regulated industry," explains Mix. "It's a virtual partnership," he says, "with the drug industry covering about 55% of the budget for the drug division of the FDA."
Mix's award-winning book, "The Price of Ovulation," exposes what goes on behind closed doors in the drug industry, while following his 35-year battle with the manufacturer of the fertility drug, Clomid. "We have got to take the fox out of the henhouse," he urges. "It is absolutely insane that the FDA relies upon the results of premarket studies conducted by the drug companies themselves rather than an impartial entity, such as the National Institutes of Health."
"This is not rocket science," says Mix. "A drug company stands to lose hundreds of millions of dollars if a new drug does not get the FDA's approval for market launch. And well over 50% of all drugs entering the market have a serious side effect that no one knows about - other than perhaps the drug companies marketing them." He cites our experience with Vioxx as just one example. Released in May 1999, the drug was intended to provide pain relief for arthritis without the risk of internal bleeding caused by older drugs. It has been estimated that by the time Vioxx was pulled from the market in September 2004, between 26,000 and 56,000 of its users died from heart attacks and strokes induced by the drug. Later litigation against Merck disclosed that the company knew about this risk even before the drug was approved by the FDA for the American market.
Mix says that by remodeling the FDA and the procedures for the premarket testing of drugs - and eliminating the multiple conflicts of interest which infect the system - his plan could save one million lives and $1 trillion in healthcare costs in 10 years.
"When it comes to Congress, there is strength in numbers," says Mix, "especially when each and every one of them is a potential voter." He urges everyone to click on his website at www.FDAreformpetition.com and sign his petition. Details on his proposal are available for review at the site. "My goal is to save lives," he says, "but I will need support if I have any hope of penetrating the wall around Congress constructed by the drug industry. Perhaps with a petition endorsed by thousands, all speaking in a unified voice, we might just actually succeed."
Terence Mix is an attorney/author who writes about reform of the FDA and drug industry. For additional information, please contact him at email@example.com
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