Archive for February, 2010

New York Wants to Mandate HPV for School Kids

Saturday, February 20th, 2010

The Alliance for Human Research Protection (AHRP) reported last week that the New York State Senate Senate is about to vote on legislation permitting a school nurse of doctor the power to vaccinate children under 18 with the controversial vaccine, Gardasil (and hepatitis B) without parental “consent or knowledge.”Gardasil, a human papilloma virus vaccine, promoted by Merck as an immunization against cervical cancer, is riddled with controversy, and covered extensively in the media, and in my previous blogs.

Dr. Diane Harper, an acknowledged researcher who conducted pre-marketing clinical trials for both Gardasil and GlaxoSmithKline’s Cevarix vaccines, blasted marketing strategies for HPV vaccine, offered the New York State Committee her expert opinion on the vaccines. As Dr. Harper and others have already written, its period of effectiveness is unknown, and evidence shows it poses serious risks for some children and young women such that its risk/benefits are highly debatable.

AHRP has stated the bill, S4779B, violates parental rights to make medical decisions on behalf of their children. If a child is harmed by a vaccine given without consent, and, according to this law, beyond the bounds of school authority, who will bear medical, financial, and Legal authority? In a landmark decision last March, the U.S. Supreme Court ruled that in case of severe injuries or death, federal law does not prevent consumers from suing drug companies in State Court.

But who, if anyone would be entitled to sue the drug company or the State of New York-or both- in cases of misadventure following mandated vaccination of the HPV vaccine?To be noted is Merck’s record of aggressive, illegal marketing of drugs including the Gardasil vaccine.According to the AHRP Newsletter, Merck is on record of having bribed state legislators to support similar bills in Texas. Merck indeed made campaign contributions to the Governor of  Texas to mandate Gardasil. Other states are considering mandating HPV vaccinations. In my opinion, the HPV controversy should be investigated by the FTC, and the FDA if not the Congress.For further information, contact: Vera Hassner Sharav at veracare@ahrp.org

Chantix: Promotion and Perils

Saturday, February 13th, 2010

Most patients with susceptible cancers are thankful for chemotherapy and radiation, and are willing to suffer crippling and dangerous side effects, even death, if treatment can help them or prolong their lives. But would you take a drug to treat a bad smoking habit with more warnings than a travel advisory to a war zone, and 90,000 URL’s under its combined search term for “adverse reactions”?

I guess it depends on what you read about Chantix, (Champix in Europe), the trade name for Varenicline, marketed in the U.S. by Pfizer to treat smoking addiction. For starters, the ad for doctor, running for weeks in the JAMA, has almost two pages out of four of “important safety information”- warnings and adverse reactions. Included in the ad are neuropsychiatric symptoms ranging from suicidal and violent behavior, worsening of psychiatric illness, as well as  nausea, sleep disturbance, constipation, vomiting, to which you might add Steven Johnson Sydrome, Erythma Multiforme, and angioedema, etc.

The drug portal, druglib.com  reported an index of adverse events during 2007 alone of 2319 serious events related to ingestion of Chantix from patients and non-professionals Cases resulting in death, 42, life-threatening events, 52, hospitalizations, 306. Because of the findings of a medical watchdog group, the Institute for Safe Medication Practices (ISMP), the drug has been grounded by the FAA for pilots and air traffic controllers. Fearing for the safety of passengers. 150 pilots and 30 ground controllers were ordered to stop taking the drug. The ISMP findings indicate from May 2006 until December 2007 there were 227 reports of suicide attempts, 28 actual suicides, 397 cases of possible psychosis and 52 reports of hostility or aggression. The latter, according to the news report, is what led to the death of popular Dallas musician Carter Albrecht, “…after he flipped out, assaulted his girlfriend and attempted to break into a neighbor’s home before being shot dead.”

A “Black Box Warning(a notice on the packaging of a prescription drug which warns patients and prescribers that the drug has potentially dangerous side effects) was not issued by the FDA until July 2009, 14 months after the FAA issued their edict for pilots and air traffic controllers! I seriously wonder how a drug for smoking addiction can survive the press it’s been receiving for almost three years and why doctors and patients continue to use a drug with this reputation. Will Chantix finally be taken off the market, or will the FDA, as is too often the case, cave in to pressure from Big Pharma, just as the medical profession and the public continue to succumb to drug advertising blitzes?