Archive for September, 2009

Fibromyalgia: Does it Exist?

Friday, September 25th, 2009

The doctor who wrote the now classic 1990 paper defined fibromyalgia as widespread pain, mostly of middle-aged women, of unknown origin, without definite physical or laboratory findings now claims he was wrong, that the disease does not exist. He accurately predicted that Lyrica, on which Pfizer spent $50 million in 2007 to advertise, and the other drugs taken to relieve sufferers will be consumed by millions of people who do not need them. Yet advocacy groups, many partly supported by drug companies, and tens of thousands of physicians who treat fibromyalgia estimate that 6-12 million Americans suffer from the disorder.

Dr. Nortin Hadler, a rheumatologist and professor of medicine at the University of North Carolina who has written extensively on fibromyalgia, stated, “These people live under a cloud. And the more they seem to be around the medical establishment, the sicker they get.” Dr. Frederick Wolfe, the lead author of the original paper referred to above, and Director of the National Databank for Rheumatic Diseases, referred to by the New York Times (Jan.14, 2008), says he has become cynical and discouraged about the diagnosis, and now considers the condition a physical response to stress, depression, and economic and social anxiety.

The argument over fibromyalgia brings up many thorny questions I have previously addressed in my newsletters. See also this on the “medicalization of America and “disease mongering.” Once the argument over the existence of a disease, disorder, or diagnosis is apparently accepted, even if later it is the subject of controversy, it receives an ICD-9 code (the International Classification of Disease) and is officially recognized.

Fibromyalgia did achieve code recognition as 729.1, a subclassification, “Other disorders of soft tissues, myalgia and myositis, unspecified,” thus allowing its entry into statistical respectability. The definition, however, is imprecise, if not confusing. (To be fair, many ICD-9 codes employ the word “unspecified.”) Does a name or a billing code give an entity a medical reality? Can a condition be fictitious or invented?

Reduced to the ultimate choice for the medical establishment, if not the public: Do we ignore millions of patients by depriving them of their disease and possible treatment, or do we save them from the exposure to another potentially risky drug and billions of dollars of needless medical attention?

More Glitches with Gardasil

Tuesday, September 8th, 2009

The Gezondheidsraad (Dutch Health Council advising authorities on health matters) admitted in a position Report on cervical cancer.”…Whether HPV vac­ci­na­tion sat­is­fies the…cri­te­ri­on – that the vac­ci­na­tion should be an ef­fec­tive means of pre­vent­ing the rel­e­vant disease – is harder to say. The vac­cines have been de­vel­oped only re­cent­ly and, because the in­ter­val between HPV in­fec­tion and the de­vel­op­ment of cer­vi­cal cancer av­er­ages about twenty years, there are as yet no data to show whether vac­ci­na­tion leads to a fall in the in­ci­dence of cer­vi­cal cancer…”

Yet a few paragraphs later, the Council states: “As­sess­ment against the cri­te­ria sug­gests that the ad­mis­sion of HPV vac­ci­na­tion to the NIP (National Immunization Program) would be jus­ti­fied.” Accordingly,  a mass vaccination program was undertaken. There was such a furor in the Dutch press about Gardasil earlier this year that intended the vaccination plan failed in large part.

A paper “Marketing HPV Vaccine” the JAMA described how Merck, whose sales of Gardasil totaled $1.4 billion last year, provided professional medical societies with gran money the organizations used to develop educational programs promoting the product. “The lectures glossed over questions about the vaccine’s effectiveness and whether booster shots would be needed,” said Dr. Sheila M. Rothman, the paper’s author.

I quoted another study in the JAMA in my newsletter in which the authors admitted that the analysis was based on imperfect data. An accompanying editorial questioned whether any level or risk is acceptable when inoculating a healthy population against a disease that can be prevented through screening.

Questions on Gardasil and Cervarix-1

Wednesday, September 2nd, 2009

An error in the premise will appear in the conclusion.

Baxter’s Law (Anon.)

The new vaccines, Gardasil by Merck and Cervarix by GlaxoSmithKline targets the human papilloma virus (HPV), a sexually transmitted virus of which there are over 100 types. Two have been found in 70% of human cervical cancers, but the vaccine has never been proven to prevent this cancer, since it will take another 20-30 years and millions of patients to prove its effectiveness. Sales are exploding since the vaccine was approved by the FDA in 2006, with 23 million doses distributed in the U.S., and 40 million worldwide. Attempts have been made to make immunizations mandatory in preteen girls in 23 states, as the CDC and major medical organizations have advised routine vaccination for girls beginning at age 11-12.

But wait.  Does this sound like a “slam dunk”? Over 12,400 adverse reactions and 32 deaths have been blamed on the vaccine. Some risk is acceptable in any vaccine proven effective against major diseases such as flu, and measles.  But in a vaccine that probably protects for only 5 years, if it is indeed proven effective for the 5 years it is claimed, against a cancer that is increasingly rare (13,000 cases last year), and virtually 100% detectable by pap screening-almost all 3,900 deaths occurred in unscreened women-one wonders if any risk is worth it.

Since all women vaccinated or not, will continue to require pap screening anyway for detection of cervical or uterine cancer well into adult life, the logic of exposing millions of girls to ANY risk of an unproven vaccine that possibly protects 70% of women, is indeed questionable. If one started immunizing pre-teen girls, it would require booster shots every 5 years until  the average age 30 and beyond, when cervical cancer generally occurs. Would the vaccine, incidentally, the most expensive on record, $400-$1000 per set of three shots, then have to be continued every five years to age 45? Merck, which has already made $1.5 billion on the vaccine has already asked for FDA approval for this recommendation, along with a request for treating boys starting at age 9, as well as men, to help prevent genital warts.

Stay tuned.