Congress can deliver a pain-free health care plan – and the solution is right in its own back yard. In Rockville, Maryland, actually, at the Center for Drug Evaluation and Research (CDER) of the Federal Food and Drug Administration (FDA), the division responsible for the approval and monitoring of prescription and nonprescription drugs. And it won’t require raising taxes on the wealthy, penalizing individuals and employers who don’t purchase health insurance or reducing Medicare payments to medical providers. It will only require fixing the archaic and inefficient methods and practices of the CDER branch of the FDA.
Consider these statistics…
More than 50% of all serious adverse reactions to drugs are discovered after the drugs are initially marketed (e.g., they are not detected during premarket testing). About 2,270,000 patients per year incur hospital costs as a result of adverse drug reactions.
Another 4,300,000 visit other health care providers (physicians, hospital outpatient departments and emergency rooms) as a result of adverse drug reactions. Approximately 230,000 die each year as a result of an adverse drug reaction (105,000 using drugs as directed and 125,000 from not following directions) – the fourth leading cause of death in the United States. The total annual health care cost as a consequence of adverse drug reactions exceeds a staggering $200 billion – an amount equal to what is spent on Medicaid every year and almost half of what is spent on Medicare.
This cost can be cut in half – easily – by fixing everything that is wrong with the FDA and the system of testing drugs. This would amount to health care savings of at least $100 billion per year – one trillion dollars over ten years.
In general terms, this can be accomplished by two major changes: (1) Taking away the premarket/pre-approval testing of drugs from the pharmaceutical companies and placing it with an impartial and unbiased third party, such as the National Institutes of Health; and (2) streamlining CDER, such that decisions about warnings, needed studies and removal of drugs from the market are promptly and efficiently made within 60 days, rather than several months, years and – in some instances – decades, while tens of thousands of victims suffer devastating and often fatal adverse reactions to drugs.
PREMARKET STUDIES
If an adverse reaction occurs only once in 100,000 users – or even once in every 10,000 – then missing a serious side effect from a drug might be understandable. But when the incidence is less than 1/1000, this is not only unacceptable, it is inexcusable. When evidence of a serious and fatal drug reaction surfaces only three months after the drug was introduced on the market – as it did with Baycol (cerivastatin) – something is horribly wrong with our premarket testing system. An adverse reaction that occurs at an incidence of less than 1/2500 should be detected during premarket clinical studies – no exception. But unfortunately, the general public has become the unwitting guinea pig for the testing of new drugs.
Allowing the fox to guard the henhouse has been a major problem for decades. Currently, drug companies design, supervise and conduct all of their own premarket studies, then compile the statistics, summarize them and ultimately spoon-feed the FDA with its own spin on the data. And the documented abuses over the years are legion. With tens of millions of dollars invested in premarket research and FDA approval the only means to recoup the investment, drug companies are highly biased and motivated to pursue any and all action necessary to obtain that approval.
POSTMARKET FDA ACTION
When the Food and Drug Amendments Act of 2007 was passed in September 2007, it was intended to extend postmarket power to CDER, which was to some extent lacking prior to its passage. Yet over the past 22 months, it has shown little inclination to abandon its established pattern of procrastination and apparent indifference to the urgency of addressing a serious drug risk that is impacting a large segment of the population.
Within ten months after Vioxx was first marketed, a study was released reporting that users were 3 times more likely to have a heart attack than users of a competing pain reliever. Yet only after 5 more incriminating studies and 3½ years had passed was the drug removed from the market (October 2004), and then only because of the voluntary decision by the drug’s manufacturer, Merck & Co. It has been estimated that as many as 88,000 to 139,000 users of Vioxx suffered heart attacks – 30 to 40% of them fatal – prior to its removal. This unfortunate pattern continues to this day.
A CLOSER LOOK
For a behind-the-scenes look at what goes on in the drug industry and how pharmaceutical companies manipulate and deceive the FDA, my nonfiction book, THE PRICE OF OVULATION: the Truth about Fertility Drugs and Birth Defects – and a Solution to the Problem, explores in depth all of the problems associated with the current system of testing and monitoring drugs. The book follows the 45-plus-year history of the fertility drug, Clomid, while detailing and documenting how its manufacturer concealed reports of birth defects, disregarded requests for warnings and further studies, and employed deceptive language in its product labeling – all facilitated by an indifferent FDA that is more concerned about rushing drugs to market than the safety of the consuming public it is obligated to protect.
With these advocated changes, not only would we facilitate a plan that could pay for universal health insurance all by itself, but also save 100,000 lives annually and immeasurable suffering in the process.
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