Tom Curb, R.Ph.

Although history has dispelled such threats, hardly a day goes by that there is not some statement by the international drug cartel, their supporters, or their lackeys proclaiming the dangers inherent in drug importation from foreign sources. As CNN reported on August 18, even President Bush is parroting the drug cartel’s rhetoric: "With political pressure mounting to allow imports of cheaper prescription drugs from Canada and other countries…(Bush) appeared to move closer to supporting the idea…if the safety of the drugs could be assured."

However, the facts prove that with respect to counterfeit, diverted or sub-standard drugs, Americans are much more at risk when obtaining medications from within the U.S. The same may even be true for potential pharmacy errors. Although a single international dispensing error recently made national headlines, during the first three quarters of 2004 more than sixty actions for dispensing errors were quietly brought against pharmacies and pharmacists by the Texas Board of Pharmacy. It is significant that these were just those due to complaints that generated Board action – one can only speculate as to how many errors were not discovered or reported. (This is not meant as a criticism of Texas pharmacists – it is for comparison only. It has always been my contention that anyone dispensing prescriptions will eventually make errors.)

But, the local or international potential for injury to Americans from substandard drugs or dispensing errors pales in comparison to the dangers inherent in the U.S. drug regulatory system. Case in point: The recent FDA admission of dangers from SSRI antidepressants is just the latest revelation in a frightening trend wherein the FDA’s administrators consistently override the cautions and objections of experts, including their own, to appease drug manufacturers.

The tardy FDA condemnation of SSRI-antidepressants for juveniles follows the pattern of Propulsid, Seldane, and Hismanal along with one exhibited by "FDA-approved" drugs whose previously known and proven dangers were so malignant that manufacturers and the FDA could not defend them to patent expiry.** These include the fenfluramine half of fen-phen* (a drug that more than 100,000 former users now claim caused heart damage and/or a deadly lung condition) as well as Rezulin, Oraflex, Zomax, Omniflox, Redux and Baycol – just to name a few.

Old time "druggists" such as myself can recall a time when FDA-approval was the gold standard for product quality and efficacy. How did it happen that a federal agency created to protect American consumers from the drug industry became so subservient to the multinational drug cartel’s whims? A recent "Frontline" expose revealing the increasingly incestuous relationship between the drug cartel and the FDA answers a lot of questions, proving the old Greek theory to "follow the money." Today, the drug industry’s contribution to FDA funding is such that it is tantamount to that federal agency’s being the drug cartel’s employee.

While individuals’ medical problems caused by these agency shortcomings are bad enough, seldom does one consider their resulting cost to the healthcare system, to consumers, to employer benefit plans, and to insurers. These bureaucratic actions and policies make consumers and insurers take two financial "hits": They have to pay the exorbitant prices for these drugs and then the cost of treatment for any medical problems they cause.

Examples such as these that illustrate the "unholy" relationship between the multinational drug cartel and the U.S. government along with state and federal regulatory agencies, educational institutions and research/analytical physicians and scientists do not bode well for U.S. consumers and insurers. Perhaps Pogo was right – "We have seen the enemy, and it is us."

* Despite known and reported problems, the FDA acted against fenfluramine only after it was warned that an obscure rural physician had voiced his concerns to the Mayo Clinic and that the two intended to expose the drug’s dangers in a nation-wide news conference.

** Although as a physician, the previous head of FDA and now head of Medicare, Dr. Mark McClellan’s primary admonition should have been "First, do no harm", he encouraged the FDA philosophy that: "Delays in approving drugs…could be just as bad as letting a dangerous medication to market." Although this made Dr. McClellan a favorite of drug manufacturers, because of the archaic, inefficient, and illogical FDA procedures for reporting and addressing adverse drug events, the policy will continue to be a recipe for disaster – and American consumers and insurers will reap the bitter fruit.