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From the Townsend Letter
May 2007


Letter from the Publisher
by Jonathan Collin, MD

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One of my pet peeves with alternative medicine has been the incessant editorializing by practitioners and newsletter writers who declare pharmaceuticals are terrible medicine, dangerous to health, even life-threatening. True, reports have demonstrated the relatively high rate of iatrogenic disease – that is, disease brought on by doctors and hospitals, due to the abuse or misuse of medication. The incidence of iatrogenic disease caused by use of drug agents is staggering: studies in medical journals have reported that over 100,000 deaths may be attributed yearly to adverse effects of medication. Still, do we really want to throw out all pharmaceutical agents because of iatrogenic disease and death? How many of us would like to roll back the clock to 1870 when the only pharmaceuticals available were aspirin, tinctures of turpentine, and liver tonics? Perhaps a portion of the alternative community would delight in just such a possibility, but the majority of us appreciate the fact that pharmaceuticals exist and are being reformulated and that drug companies are engaged in research for newer drugs. I know that naturopathic physicians enjoy the use of USP thyroid, a drug agent. Naturopathic doctors are licensed to prescribe low-potency antibiotics, like ampicillin, an agent that did not exist in 1870. Older drugs patented 40 or more years ago are part and parcel of most alternative practitioners' prescribing: hydrochlorothiazide (diuretic), furosemide (diuretic), hydrocortisone (adrenal hormone), nystatin (anti-fungal), cephaloxin (antibiotic), and diazepam (anti-anxiety agent), to name just a few. Wouldn't medicine be a horrible place if all these drug agents disappeared?

Safety Concerns
Safety is a primary concern with pharmaceuticals, especially with the high incidence of associated adverse effects. One problem has been the misreading of prescriptions. Difficulties in reading doctors' scrawls and in differentiating similar-sounding drug names (for example, Zantac [a stomach acid reducer] vs. Xanax [an anti-anxiety drug]) have led to the medications being incorrectly prescribed or administered. The State of Washington has mandated that physicians must now write any medical prescription in block-print format or use an electronically printed prescription.

The wrong dispensing of medication is inexcusable, but what about the failure to know about the side effects of medications? Pharmaceutical critics argue that drug companies spends millions in getting a drug approved but very little in monitoring the new drug once it has been formally licensed by the Food and Drug Administration (FDA). Only after patients using the drug became seriously ill or died have many blockbuster new drugs been found to cause serious adverse effects. The discovery that the anti-inflammatory drug Vioxx contributed to the increased incidence of myocardial infarction in thousands of patients led to the recall of the drug as well as to an overwhelming number of patient lawsuits. The FDA is now requiring drug companies to monitor all newly approved pharmaceuticals for adverse effects and to report all serious reactions and deaths.

Drug Adulteration
While the FDA requirement for monitoring drug adverse effects is a step in the right direction, there is a much more serious risk to drug safety: pharmaceutical adulteration. This is not the manufacture of second-rate generic drugs or the importation of brand-name knockoffs from India and Malaysia (although that is a definite concern in and of itself). What I am concerned about is the criminal element insinuating itself in the distribution of pharmaceuticals to pharmacies. One result of the success the Drug Enforcement Agency (DEA) has had in curtailing the cocaine, opium, and marijuana drug trades has been the movement of the criminal element into the pharmaceutical business. No, the criminals are not manufacturing drugs. Why should they when there are great profit margins for the taking in distributing prescription drugs? The business of drug wholesaling offers a golden business opportunity in Florida, Texas, Nevada, Georgia, Missouri, South Carolina – virtually every state in the country. Up until a few years ago, anyone could apply in Florida for a state license to operate a wholesale pharmaceutical company.

Pharmaceuticals, contrary to popular belief, are not shipped from Merck, Pfizer, or other major drug manufacturers to the pharmacy. Pharmacies receive drug shipments from wholesalers. In the US, there are now only three major national wholesalers, including Cardinal Health and AmerisourceBergen. These major wholesalers supply regional wholesalers, which stock the drugs for most pharmacies. However, a pharmacy is not required to get their drug stock from a major or regional wholesaler. A pharmacy may obtain their prescription supply from any "wholesaler," anywhere in the US, even if that wholesaler is operated illegitimately. So when a pharmacy in Maine needs its supply of Lipitor replenished, that pharmacy may contact, say, "J&C Pharmaceuticals" of Orlando, Florida to get new stock. The trouble is that the Lipitor that J&C Pharmaceuticals ships to the Maine pharmacy may or may not be Lipitor, may or may not be 40 mg of Lipitor (it may be 80 mg, 20 mg, or even 0 mg), and may or may not be the Lipitor manufactured by Pfizer.

The underworld of "J&C" wholesale pharmaceuticals is often operated by criminals with little knowledge of medicine or pharmacy. Salesmen for these operations rarely acquire their drugs from the national or regional wholesalers. More often then not, salesmen have a clandestine meeting in the parking lot or in the bathroom of the strip club, exchanging drug supplies for cash at the lowest price possible. Of course, the drugs would not move if they were not far cheaper than the legitimate wholesale price. Another favorite means to acquire drugs is to bribe Medicare or Medicaid patients to give up drug samples dispensed at the clinic site. The big score in the sordid wholesale world is to steal expensive oral and intravenous drugs from clinic and hospital dispensaries. Up until four years ago, Florida had little knowledge that wholesale drug operators engaged in criminal means to peddle prescription drugs as a big business. In 2004, Florida investigated and indicted at least 25 individuals involved in these illegitimate drug operations. At least in Florida, wholesale drug operations are now being scrutinized.

Sleazy Operators
How sleazy and slick can these operators get? It is hard to imagine the extreme measures wholesale drug operators will take to profit in pharmaceutical distribution. Everyone knows that chemotherapy is big business. Private clinics and hospital oncology departments administer chemotherapy, billing insurance companies and Medicare enormous amounts to cover drug costs and profits. Profit margins for the wholesalers are not necessarily substantial for these expensive drugs. When the wholesaler buys a chemotherapy injectable for $350, the selling price to the hospital or oncology office is only five to ten percent more. But wouldn't it be nice, as a wholesaler, if you could purchase the injectable for $30 instead of $350? That would be a much nicer profit margin. One drug agent, Epogen®, is used to treat the anemia associated with chemotherapy. Epogen, also known as erythropoietin, is a powerful agent, enabling cancer patients to fend off the terrible fatigue and pain that comes with untreated anemia. So, when an oncologist prescribes and administers Epogen, but the drug is adulterated to less than three percent of the labeled dose and mixed with a questionable liquid, one can imagine the horrible effect the altered Epogen would have on the patient. Sad to say, Epogen was adulterated by an illegitimate Florida wholesaler five years ago. The book
Dangerous Doses by Katherine Eban (Harcourt, 2005) describes the nightmare experience of two patients who were victims of a group of criminal Florida wholesale drug companies that distributed adulterated Epogen. The process involved the wholesale drug operator acquiring a small number of high-dose Epogen vials to legitimize the process. The high-dose erythropoietin was diluted in unsanitary conditions and decanted into thousands of similar-looking vials, then falsely labeled as high-dose Epogen. The secret of the process was the detail work of the printer who printed labels to match the detail of the actual Epogen vial, including legitimate lot numbers. For piecework wages, laborers were hired to glue on the labels, but the glue work would often bleed through, easily distinguishing the real Epogen from the counterfeit. It would be hard for Hollywood to come up with a better plot. Profit margins for the false Epogen ran into hundreds of millions of dollars.

At the time
Dangerous Doses was written, the perpetrators of the Epogen hoax were under indictment but not yet imprisoned. Katherine Eban, an investigative journalist, suggests that Congress, state legislatures, the FDA, DEA, and the pharmacy boards of each state should regulate wholesale pharmaceutical sales, requiring a "pedigree," certifying the legitimacy of any drug shipment and proving the authenticity of drug manufacturing and transport. The wholesale pharmaceutical companies should be licensed, with operators who have formal pharmacy education. Dangerous Doses showed that most of these so-called wholesalers were simply office facilities in business parks with no legitimate pharmaceutical operations. Such sham facilities should be inspected and shut down. Pharmacies should be permitted to replenish their drug stock only from legitimate wholesale operations. Unless we regulate these drug sales, there will be no certainty that patient prescriptions will be filled with unadulterated medications.

Metabolic Syndrome and Diabetes
The May issue of the
Townsend Letter focuses on metabolic syndrome and diabetes. Dr. Majid Ali and Dr. Garth Nicolson hypothesize that mitochondrial dysfunction and oxidative stress underlie metabolic syndrome and diabetes. Dr. Alan Gaby conjectures that chemical pollution is increasing the incidence of diabetes. Dr. Jeffrey Bland comments on the role of inflammatory cytokines in metabolic syndrome and cardiovascular disease. Kerry Bone examines the herb Coleus forskohlii in treating metabolic syndrome, while Ken Jones reviews evidence that aloe vera is useful in glycemic control of diabetes. Dr. Stephen Holt and Dr. Ingrid Kohlstadt describe therapeutic protocols for supporting metabolic syndrome; Dr. Alex Tan proposes a treatment protocol for diabetic kidney disease; and Dr. David Watts uses hair analysis as a tool to define metabolic syndrome. We also continue Dr. J. Waterhouse's article on the Marshall Protocol for treating Lyme disease, and we offer Part 2 of Dr. Vojdani's evaluation of a new laboratory test for Lyme disease.

Finally, we are currently seeking submissions for our July issue. We invite readers to submit articles and letters regarding their experiences with the treatment of cardiovascular disease and congestive heart failure (CHF). Deadline for submissions is April 25, 2007.


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