The Health Care Dilemma - A Painless Solution

Congress can deliver a pain-free health care plan -incidence of less than 1/2500 should be detected
and the solution is right in its own back yard. Induring premarket clinical studies - no exception.
Rockville, Maryland, actually, at the Center forBut unfortunately, the general public has become
Drug Evaluation and Research (CDER) of thethe unwitting guinea pig for the testing of new
Federal Food and Drug Administration (FDA), thedrugs.
division responsible for the approval andAllowing the fox to guard the henhouse has been
monitoring of prescription and nonprescriptiona major problem for decades. Currently, drug
drugs. And it won't require raising taxes on thecompanies design, supervise and conduct all of
wealthy, penalizing individuals and employers whotheir own premarket studies, then compile the
don't purchase health insurance or reducingstatistics, summarize them and ultimately
Medicare payments to medical providers. It willspoon-feed the FDA with its own spin on the
only require fixing the archaic and inefficientdata. And the documented abuses over the years
methods and practices of the CDER branch ofare legion. With tens of millions of dollars invested
the FDA.in premarket research and FDA approval the only
Consider these statistics...means to recoup the investment, drug companies
- More than 50% of all serious adverse reactionsare highly biased and motivated to pursue any
to drugs are discovered after the drugs areand all action necessary to obtain that approval.
initially marketed (e.g., they are not detectedPOSTMARKET FDA ACTION
during premarket testing).When the Food and Drug Amendments Act of
- About 2,270,000 patients per year incur hospital2007 was passed in September 2007, it was
costs as a result of adverse drug reactions.intended to extend postmarket power to CDER,
- Another 4,300,000 visit other health carewhich was to some extent lacking prior to its
providers (physicians, hospital outpatientpassage. Yet over the past 22 months, it has
departments and emergency rooms) as a resultshown little inclination to abandon its established
of adverse drug reactions.pattern of procrastination and apparent
- Approximately 230,000 die each year as a resultindifference to the urgency of addressing a
of an adverse drug reaction (105,000 using drugsserious drug risk that is impacting a large segment
as directed and 125,000 from not followingof the population.
directions) - the fourth leading cause of death inWithin ten months after Vioxx was first
the United States.marketed, a study was released reporting that
- The total annual health care cost as ausers were 3 times more likely to have a heart
consequence of adverse drug reactions exceedsattack than users of a competing pain reliever.
a staggering $200 billion - an amount equal toYet only after 5 more incriminating studies and
what is spent on Medicaid every year and almost3½ years had passed was the drug
half of what is spent on Medicare.removed from the market (October 2004), and
This cost can be cut in half - easily - by fixingthen only because of the voluntary decision by
everything that is wrong with the FDA and thethe drug's manufacturer, Merck & Co. It has
system of testing drugs. This would amount tobeen estimated that as many as 88,000 to
health care savings of at least $100 billion per139,000 users of Vioxx suffered heart attacks -
year - one trillion dollars over ten years.30 to 40% of them fatal - prior to its removal.
In general terms, this can be accomplished byThis unfortunate pattern continues to this day.
two major changes: (1) Taking away theA CLOSER LOOK
premarket/pre-approval testing of drugs from theFor a behind-the-scenes look at what goes on in
pharmaceutical companies and placing it with anthe drug industry and how pharmaceutical
impartial and unbiased third party, such as thecompanies manipulate and deceive the FDA, my
National Institutes of Health; and (2) streamliningnonfiction book, THE PRICE OF OVULATION: the
CDER, such that decisions about warnings, neededTruth about Fertility Drugs and Birth Defects -
studies and removal of drugs from the marketand a Solution to the Problem, explores in depth all
are promptly and efficiently made within 60 days,of the problems associated with the current
rather than several months, years and - in somesystem of testing and monitoring drugs. The book
instances - decades, while tens of thousands offollows the 45-plus-year history of the fertility
victims suffer devastating and often fatal adversedrug, Clomid, while detailing and documenting how
reactions to drugs.its manufacturer concealed reports of birth
PREMARKET STUDIESdefects, disregarded requests for warnings and
If an adverse reaction occurs only once infurther studies, and employed deceptive language
100,000 users - or even once in every 10,000 -in its product labeling - all facilitated by an
then missing a serious side effect from a drugindifferent FDA that is more concerned about
might be understandable. But when the incidencerushing drugs to market than the safety of the
is less than 1/1000, this is not only unacceptable, itconsuming public it is obligated to protect.
is inexcusable. When evidence of a serious andWith these advocated changes, not only would
fatal drug reaction surfaces only three monthswe facilitate a plan that could pay for universal
after the drug was introduced on the market - ashealth insurance all by itself, but also save 100,000
it did with Baycol (cerivastatin) - something islives annually and immeasurable suffering in the
horribly wrong with our premarket testingprocess.
system. An adverse reaction that occurs at an