Tom Curb, R.Ph.

(When the health and safety of American patients or the economic interest of consumers conflict with the objectives of the multinational drug cartel, American patients have virtually no advocates. For decades, the drug cartel has overcharged U.S. consumers and used a portion of that excess to "buy" allegiance from other entities and individuals that can impact healthcare costs. Some that are often illegitimately influenced by drug manufacturers include state and federal regulators; professional associations; purchasing agents; consultants; third party administrators; educators; politicians; and various types of healthcare providers, administrators and benefits managers.)

Today’s criticism of the FDA with respect to its inept handling of Vioxx follows the latest in a series of agency "embarrassments" - this being most recently preceded by that of antidepressants. Undoubtedly the often criticized "employment revolving door" between FDA administrators and the drug companies that FDA was created to regulate contributed to FDA’s "silencing one of its own drug experts who raised safety concerns (about Vioxx) weeks before Merck yanked its blockbuster drug". (Merck acted under the threat of potential for liability costs exceeding an already "estimated $10 billion or more.") But the FDA is not alone in "criticism due":

When asked questions about medications’ importation, President Bush stated, "I believe my primary responsibility is to protect the safety and well-being of the American people"; however, continuing evidence that his administration and appointees favor special interests over patient welfare comes as no surprise. Prior to his presidency, I directly petitioned then "Governor" Bush to thwart prescription legislation that would endanger Texans. Since the legislation was supported by influential special interest groups, Governor Bush ignored my pleas and enabled the bill to become law. Although the regulation did not impact me personally, I appeared as the only patient advocate at the bill’s public hearing. My argument against the dangerous element was effective, and support for that aspect evaporated to the extent that the Senate co-author of the legislation withdrew endorsement of that portion of her own bill! Since Governor Bush placed special interests ahead of the health and safety of citizens of his own adopted state - as President, there was no anticipation that he would be any more considerate of other Americans.

Federal officials’ and agencies’ support for special interests are accompanied by anti-consumer, anti-patient efforts of state regulators. Even in my early career, to impede competition from "discount pharmacies", state agencies (supported by pharmacy associations and educators) passed laws making it illegal to advertise the price of a drug. To make discounters’ intrusion even more difficult, they made it illegal to include the name of the drug on the Rx label - or even to tell the patient the name of their drug without the express consent of the doctor. We did not have today’s ready-reference drug identifiers and central profiling, and pharmacists were routinely "called out" at night to research what drugs some child in an emergency room might have taken. To protect drug manufacturer profits, state agencies also passed laws prohibiting pharmacists and patients from "conspiring" to substitute generics for brand-name drugs.

(A recent indicator of the drug cartel’s influence peddling at the academic level is that during the 2002-2003 school year, 85% of "contributions greater than $24,000" to University of Texas College of Pharmacy affiliates came from drug manufacturers and distributors.)

Fortunately, because these special-interest state regulations could not pass the "smell test", Texas consumers eventually forced their overthrow. Today, Texas pharmacists must put the name of a drug on the label, and they must inform about and offer patients available generics. So there is hope, and although there are more drug industry lobbyists than legislators on Capitol Hill, no doubt American consumers and their champions will force current and federal special-interest sponsored regulations to follow the same ignominious route. The movement has started:

*The Accreditation Council for Continuing Medical Education, which gives its stamp of approval for doctors’ continuing education credit classes, announced sweeping changes…to limit the influence of doctors with financial connections to the pharmaceutical industry.

*Dr. Eric Topol, a prominent cardiologist and chairman of cardiovascular medicine at the Cleveland Clinic, is calling for a congressional investigation into how the Food and Drug Administration and Merck allowed Vioxx to be marketed to millions of people in the face of indications that the painkiller could cause heart attacks and strokes. In an editorial to appear in the Oct. 21 issue of the New England Journal of Medicine, Dr. Topol writes that "neither the FDA nor Merck fulfilled its responsibilities to the public." Dr. Topol calls the FDA to task for not requiring Merck to perform studies that specifically examined the risk of cardiovascular events on patients taking Vioxx. As for Merck, he writes, "Sadly, it is clear to me that Merck's commercial interest in rofecoxib (Vioxx) sales exceeded its concern about the drug's potential cardiovascular toxicity."

*Dr. Jerry Avorn, a physician and associate professor at Harvard Medical School and an expert on the use and marketing of prescription drugs asks, "Why did it take four years to get the definitive data? Why didn't the FDA demand the company mount the appropriate study?" He said, "When this question came up initially, the standard response from the FDA was to hope the company would do its own study to resolve it, and the FDA has not been brave enough in demanding that companies perform safety studies of this kind."

*Senate Finance Committee Chairman Charles Grassley, whose staff has been investigating the FDA's handling of safety issues, sent (FDA) a letter asking for information about the agency's actions on Vioxx, saying, "Once again, the FDA has remained on the sidelines while life-threatening issues threatened the American public."

*Tom Davis, the House Government Reform Committee chairman, wrote to the FDA seeking information related to the FDA's surveillance of Vioxx stating, "I am concerned whether FDA has been sufficiently aggressive in monitoring drug safety…"

*Four Democratic lawmakers in Congress introduced legislation on October 7 that would require makers of drugs and medical devices to register clinical trials of their products in a public database when they start and report the test results on it.

*Editors of medical journals, gatekeepers for the medical profession, are expected to begin requiring that drug trials be registered at the outset as a prerequisite for the subsequent publication of their results. Requiring such registration as a condition for reaching the journals’ vast audience of doctors would make it difficult for drug companies to hide the results of unflattering tests - as some have been accused of doing.