Healthcare Reform can be painless

Expert reveals that fixing FDA can save consumers hundreds of billions


While Congress and the rest of the nation turn the battle over healthcare reform into a pro-wrestling-style steel cage death match with enough rhetoric to choke an English professor, at least one expert is looking beyond the bills on the table for a different solution.

According to a lengthy report by legal expert Terence Mix, The American Healthcare Dilemma (, reorganizing the FDA and its activities could save Americans a trillion dollars over the next decade.

“Congress can deliver a pain-free healthcare plan – and the solution is right in its own back yard,” Mix said. “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.”

Mix believes that cleaning up FDA miscues and duplicative functions can save consumers serious money in unnecessary healthcare costs, as well as free up some much-needed federal dollars. His chief complaints include:

·More than 50 percent 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 healthcare 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 third leading cause of death in the United States.

·The total annual healthcare 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.

“These costs can be cut in half by fixing everything that is wrong with the FDA and the system of testing drugs,” he added. “This would amount to health care savings of at least $100 billion per year – one trillion dollars over ten years, not to mention saving one million lives over the same period of time.”

Mix contends this can be accomplished by two major changes:

* 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

* 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.

“Allowing the fox to guard the henhouse has been a major problem for decades,” added Mix, author of the newly released book, The Price of Ovulation: The Truth About Fertility Drugs and Birth Defects – and a Solution to the Problem from Tendril Press ( Mix is an expert on fertility drugs like Clomid, whose FDA approval led to a wide variety of lawsuits from patients. “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 hundreds 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.”