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Merck’s Gardasil is one of several vaccines that might be linked to severe neurological conditions, including ALS. A CDC official says the agency is reviewing the adverse event database but has “no suspicions” of a causal relationship.

According to a recent report in U.S. News & World Report, the CDC’s associate director for immunization safety John Iskander says the thousands of adverse events including deaths associated with Merck’s wildly successful Gardasil HPV vaccine “kind of tells us that we need to look more broadly at this issue.”

Don’t you just love “kind of tells us”?

CDC’s Iskander adds that similar neurological adverse events were reported earlier, following the anthrax vaccine.

But Iskander is quick to add that “we’re doing just an initial review at this point; we don’t have suspicions that these are causally related.”

Oh sure, “we don’t have suspicions these are causally related” in spite of the painstakingly obvious connection between some vaccines and neurological damage.

And we’re undertaking a review to, um, satisfy, er, why are we doing this review again?

Meanwhile Merck and the FDA continue to echo the usual “no causality there, all coincidence” mantra one expects from those who are desperately trying to cover their butts, because they’re who’s going to catch hell when the truth is finally revealed.

It is now a cold hard fact that Gardasil adverse events reported to the federal Vaccine Adverse Events Reporting System (VAERS) are skyrocketing — five to 30 times higher than the rate of a ‘similar’ childhood vaccine.

With something like 10,200 adverse events already reported, at least 29 deaths, and hundreds of neurological and other ugly conditions, including the deadly amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s disease), something is rotten in the state of Denmark (as Marcellus remarked to Horatio in Shakespeare’s Hamlet, indicating that there’s rot at the top of the administration and it’s spreading downwards).

These numbers are already horrendous. But less than 10 percent of all adverse events following vaccination are reported, so the real numbers must be terrifying.

The National Vaccine Information Center (NVIC), the first, largest and most respected vaccine safety watchdog organization in the country, has published a review of Gardasil adverse events compared to the somewhat similar Menactra (meningococcal) vaccine. The link is to a PDF file, and anyone interested in a thorough, up-to-date look at the Gardasil situation needs to read this report — the list of Gardasil side effects will curl your hair.

The NVIC reports that through November 30, 2008, compared to Menactra, Gardasil was associated with at least twice as many Emergency Room visit reports (5,021), four times as many Death reports (29), five times as many “Did Not Recover” reports (2,017) and seven times as many “Disabled” reports (261). There have been 34 reports of thrombosis, 27 reports of lupus, 23 reports of blood clots, 16 reports of stroke, and 11 reports of vasculitis following Gardasil vaccine given alone without any other vaccines. There are three to six times more fainting or syncope reports after Gardasil vaccination than after Menactra, and 544 reports of seizures following Gardasil and 158 after Menactra (73 Menactra-associated seizures involved co-administration with Gardasil). And that’s just a smattering of the long, long list of hideous side effects.

NVIC is calling for the Obama administration to suspend Gardasil and launch a full investigation. It has a petition on line to help convince the White House and Congress to take action now, and you can sign it here.

If you didn’t click the link to sign the petition because you don’t sign petitions, read the following, which is taken from the petition:

·        Gardasil vaccine was fast tracked and licensed by the FDA in 2006 and immediately recommended by the Centers for Disease Control (CDC) for universal use by all 11-12 year old girls, teenagers and young women to age 26;

·        Merck, the drug company marketing Gardasil, was required by federal health agencies to study Gardasil side effects in only about 1200 girls 16 years old and younger and follow them up for less than two years before getting a license;

·        Merck was not required by federal health agencies to use a true placebo in pre-licensure clinical trials but compared Gardasil against a placebo that contained an unknown amount of aluminum, potentially masking the true reactivity of Gardasil, which also contains aluminum;

·        The deaths and serious health problems experienced by participants receiving Gardasil in pre-licensure clinical trials were written off by Merck as a coincidence;

·        The thousands of adverse events reported to the federal Vaccine Adverse Events Reporting System (VAERS) since Gardasil has been licensed, including deaths and serious health problems involving emergency room visits, hospitalizations, and permanent injuries, have been written off by federal health agencies as a coincidence;

·        A comparison of serious adverse events, such as death, stroke, blood clots, cardiac arrest, seizures, fainting, lupus, and rechallenge cases, reported to VAERS after Gardasil vaccination and meningococcal (Menactra) vaccination reveal that these events are reported three to 30 times more frequently after Gardasil vaccination;

·        Doctors and parents are not being informed by federal agencies or Merck about all serious adverse events associated with Gardasil so steps can be taken to monitor vaccine reactions and prevent injury and death.

Still don’t want to sign the petition? You probably work for Merck, the FDA, the CDC, or you own a bunch of Big Pharma stock.

Merck’s Gardasil, approved for females from 9 to 26, has been a successful new product thanks to agressive marketing, but regulators want to see more study results before approving it for women aged 27 to 45.

FDA has again withheld approval for Merck’s cervical cancer vaccine Gardasil for women aged 27 to 45, until they evaluate longer-term test results. Merck’s first request last year based on 24 months of results from an ongoing 48-month study was also refused.

Gardasil, a recent Merck success, was approved in 2006 for preventing cervical cancer and genital warts in females between the ages of 9 and 26. Aggressive marketing — critics consider it overly aggressive — even pushed state and local lawmakers to mandate its use among school children and immigrants.

Riding on the wave of massive sales, Merck began expanding its horizons to include the older female age groups and males. The FDA refusal letter does not affect Merck’s application to expand use to males.

Some medical experts consider Merck’s marketing claims to be inaccurate or at least misleading, and the cost of the vaccines to be exorbitant, because the vaccine only protects against a few forms of cervical cancer already easily detected by other means, such as the Pap Smear, which are readily available, widely used, and much less expensive.

Any connections between Gardasil and numerous serious adverse events, including paralysis, fainting and collapse, hallucinations, and even death, are strongly denied by the company.

An MSNBC report says Gardasil’s strong sales has waned, because the target age group is becoming saturated, and also that the vaccine is facing competition from GlaxoSmithKline’s similar product called Cervarix.

Despite the lack of scientifically valid evidence to support a dose-related effect at dosages above 1800 mg/day, the company launched a marketing campaign advocating  dosages up to and above 3600 mg/day.

A New York Times article reports that Pfizer earlier this decade “manipulated the publication of scientific studies to bolster the use of its epilepsy drug Neurontin for other disorders, while suppressing research that did not support those uses.” The charges come from experts who reviewed thousands of company documents for plaintiffs in a lawsuit against the company for promoting the drug for off-label uses it knew were ineffective.

Says the Times, “Pfizer’s tactics included delaying the publication of studies that had found no evidence the drug worked for some other disorders, “spinning” negative data to place it in a more positive light, and bundling negative findings with positive studies to neutralize the results, according to written reports by the experts, who analyzed the documents at the request of the plaintiffs’ lawyers.”

Promotion of unapproved, off label uses for Neurontin, such as bipolar disorder, certain types of pain and prevention of migraine headaches, helped propel sales of the drug to more than $3 billion a year before patent protection was lost in 2004 (the drug’s generic name is gabapentin). Publication of negative studies certainly would have impacted that bottom line, the experts said.

The reports, unsealed last Monday in a federal court in Boston, add to a growing body of evidence that Big Pharma has long been engaged in “blurring the lines between science and marketing,” the newspaper said.

For example, it was learned that Merck hired ‘ghostwriters’ to produce scientific articles about its pain reliever Vioxx, then paid prestigious doctors to serve as their official authors. After research showed it could cause strokes and heart attacks, Vioxx was withdrawn from the market in 2004, but not before it had earned billions. And Merck and Schering-Plough both have been condemned for delaying release of a study showing that its cholesterol drug Vytorin didn’t slow the growth of arterial plaque.

One of the experts, Brian Alldredge, PharmD, Professor of Clinical Pharmacy and Neurology at University of California, concluded that a review of all clinical trials failed to establish any dose-related effect (i.e., continued improvement in efficacy) at dosages above 1800 mg/day, an assertion supported by FDA rulings, yet Parke-Davis/Pfizer heavily marketed dosages up to and above 3600 mg/day. This higher dosage / higher efficacy message was strategically discussed in Parke-Davis planning documents, promoted via company-sponsored publications, continuing medical education programs and materials, and via presentations/lectures that targeted Neurontin prescribers, relying on lower quality evidence at the exclusion or minimization of higher quality evidence.

“The effect was to increase Neurontin sales, to increase Parke-Davis/Pfizer profits, and to increase the expenditures of payors (including patients),” Alldredge said

There are several important factors to look at when considering Big Pharma’s deceptive marketing practices: patient health, and the cost of health care in general

The goals of patients — better health –  and those of their physicians — to bring health and do no harm — are deliberately and criminally subverted when research is withheld or altered.

And for anyone concerned the country’s massive, out-of-control health care bill, do the math:

The cumulative cost to patients, to insurance providers, and to all levels of government involved in health care, for the purchase and administration of tens of millions, and in some cases hundreds of millions, of ineffective and even harmful prescription drugs, can cost this country hundreds of billions of dollars a year.

It’s time these realities should be interpreted legally and applied ruthlessly to any pharmaceutical company that engages in practices that place profits above the well-being of patients, and/or that threatens the viability of our health care systems.