Archive for October, 2009

Gardasil Redux

Monday, October 26th, 2009

An article in the Philadelphia Bulletin, Oct.25, by Susan Brinkmann, entitled “Gardasil Researcher Drops a Bombshell,” describes more troubling news about the vaccine.

 

Dr. Diane Harper, lead researcher in the development of two human papilloma virus (HPV) vaccines, Gardasil and Cervarix and also a consultant to the World Health Organization , said the controversial drugs will do little to reduce cervical cancer rates and, even though they’re being recommended for girls as young as nine, there have been no efficacy trials in children under the age of 15…

“Dr. Harper began her remarks by explaining that 70 percent of all HPV infections resolve themselves without treatment within a year. Within two years, the number climbs to 90 percent. Of the remaining 10 percent of HPV infections, only half will develop into cervical cancer, which leaves little need for the vaccine…

In 2007, which was at the height of Merck’s controversial drive to have the vaccine mandated in schools, Dr. Harper remained steadfastly opposed to the idea and said she had been trying for months to convince major television and print media about her concerns, “but no one will print it.”

“It is silly to mandate vaccination of 11 to 12 year old girls,” she said at the time. “There also is not enough evidence gathered on side effects to know that safety is not an issue.”

“…To date, 15,037 girls have officially reported adverse side effects from Gardasil to the Vaccine Adverse Event Reporting System (VAERS). These adverse reactions include Guillian- Barre, lupus, seizures, paralysis, blood clots, brain inflammation and many others. The CDC acknowledges that there have been 44 reported deaths.

Dr. Harper also participated in the research on Glaxo-Smith-Kline’s version of the drug, Cervarix, currently in use in the UK but not yet approved here. Since the government began administering the vaccine to school-aged girls last year, more than 2,000 patients reported some kind of adverse reaction … with 4,602 suspected side-effects recorded in total. The most tragic case involved a 14 year-old girl who dropped dead in the corridor of her school an hour after receiving the vaccination.

“I came away from the talk with the perception that the risk of adverse side effects is so much  greater than the risk of cervical cancer, I couldn’t help but question why we need the vaccine at all” said Joan Robinson, Assistant Editor at the Population Research Institute…

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Breathing Insulin: Exuberant about Exubera

Thursday, October 15th, 2009

If you could inhale insulin, wouldn’t it be an advantage over taking the hormone by injection?  Could be a good idea, eliminating the slight discomfort of a tiny needle stick a couple of times a day, but would it really be worth it? In 2006 the FDA finally approved the inhaled insulin product, Exubera by Pfizer, but the inhaler used with the product was large and awkward.  Because of the unpopularity of the product it was withdrawn.  But now a new inhaler has been introduced with faster acting insulin, and has won new FDA approval. Analysts predict that the new product could earn $2 billion a year by 2010 with worldwide sales. Some doctors, however, warn that the risks of Eubera to the lungs  have not been thoroughly tested. Although insulin by inhalation appears to work no better than insulin by injection, using the formulation and new mode of administration could take years before clinical experience is sufficient to declare that breathing insulin is safe to lung tissue. In clinical trials, Exubera caused some reduction in patient’s ability to breathe.

Human lungs contain about 300 million tiny air sacs where gas exchange takes place-air in, carbon dioxide out. Transporting gases efficiently is why it took over tens of millions of years for the lungs to evolve from fish gills.  So far as I know, these air sacs or alveoli, were never told they might have to transport a insulin, a protein molecule that is 4,000 times heavier than a simple elemental gas like oxygen.  But never worry, the Food and Drug Administration is recommending that lung function should be checked before starting Exubera and every six to twelve months thereafter. Common sense suggests that it could take another ten to twenty years or longer before we really know what inhaled insulin does to those tiny lung sacs. My humble guess is that it won’t help your breathing.

Let’s not be too exuberant about Exubera too soon-unless you hold stock in Pfizer.

 









Off-Label Marketing II

Monday, October 5th, 2009

Allergan, Inc. the makers of Botox pulled a switch recently.  The company charges in an unprecedented suit against the FDA that restrictions on promoting Botox  for unapproved uses like spasticity violate the company’s First Amendment rights to speak truthfully to doctors about its drug products! This is a direct challenge to the Government’s right, discussed in the last blog, to restrict illegal drug promotion, and, according to Jeffrey N. Gibbs a lawyer specializing in food and drug law, quoted in the New York Times, “a broad attack on the constitutionality of FDA restrictions on speech by an individual company…They are seeking relief which would invalidate all of the FDA regulations which restrict the promotion of drugs.” The operative adjective here is speak truthfully. 

Botox by injection is approved in the U.S. to treat crossed eyes, eyelid spasms, excessive sweating, wrinkles, neck contortions.  But many doctors use the drug for unapproved indications like facial spasm, vocal cord problems, and migraine. (Serious complications have occurred for these latter uses, including difficulty swallowing, and breathing difficulties.)

Talk about chutzpah, this case beats them all. If by chance this lawsuit is successful, it will result in unimaginably horrendous consequences for drug regulation and for the public health. Free speech indeed vs. “truth in advertising.” Go figure.

Off-Label Drug Marketing

Thursday, October 1st, 2009

Once the FDA approves a drug for one condition or disease, doctors are free to prescribe it for another, a situation defined as prescribing “off-label.” This is not always a good idea, but there is latitude in a legal sense to use a drug for a condition not strictly approved by regulation, but considered by the physician to be useful (if not necessarily safe or appropriate).  As for marketing, however, pharmaceutical companies are not allowed to promote such off-label uses.  Usually, when this occurs (or is discovered), the company responsible is subject to heavy fines by the FDA.

The New York Times, however, just reported that the former head of a drug company was convicted of wire fraud for issuing what federal prosecutors called a misleading press release that contributed to off-label sales of his company’s drug. The former chief executive of InterMune was, however, acquitted of the related charge of “misbranding,” that is, off-label marketing itself.  It seems like splitting legal hairs, yet the gentleman in question faces a jail term if his appeal fails.Watch Full Movie Streaming Online and Download

This should strike fear into corporate executives who can hide behind a corporate shield when they promote drugs with false or misleading information.

The whole concept of off-label use by doctors and promotion of drugs for unapproved uses of new-and old drugs-deserves to be reassessed, not only by the Government, but by the research community. I can offer many examples in a coming blog.

The next time your doctor prescribes a new drug for, let us say, fibromyalgia or depression,or anything else, it might be wise to ask him or her if this is an off-label use. Sometimes, in the case of life-threatening illness when options have been exhausted, off-label use of a drug might make sense, but in other situations, it might conceivably lead to patient-and doctor’s-remorse.