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 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
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.
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
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
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.
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
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.