What the Tea Party -- and Everyone Else -- Missed on Gardasil®

In 2008,raised some of the first serious questions about the safety and efficacy of the drug, Gardasil®, exposing Merck and Co's marketing slight of hand to peddle the new cervical cancer vaccine to girls age 9 to 26.
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Has broadcast news been subconsciously bullied, compromised by the large amount of ad dollars pharmaceutical companies have pumped into their shrinking flagship programs?

Or was it just too hard to resist focusing on another Michele Bachmann gaffe instead of the most important thing she, or just about anyone has had to say in the Republican campaign for president: that the government should not mandate vaccinating our daughters with the controversial drug, Gardasil®.

In 2008, The New York Times raised some of the first serious questions about the safety and efficacy of the drug, Gardasil®, exposing Merck and Co's marketing slight of hand to peddle the new cervical cancer vaccine to girls age 9 to 26.

Since then, the number of girls (and some boys) who have taken the triple-dose vaccine has doubled -- 35 million doses have now been administered in the U.S. with millions more in Canada and around the world.

With their early call to action so widely ignored, it was somewhat ironic that The New York Times found such a strange bedfellow in Michele Bachmann who, in the middle of the televised Tea Party debate, blasted her Republican opponent Rick Perry for signing an executive order in Texas to mandate the controversial vaccine for all girls in his state.

Unfortunately, instead of shining light on a health issue certainly worthy of a presidential-level debate, Rep. Bachmann only succeeded in muddying the already murky waters when she appeared on the "Today Show" and spoke about a random mother who had just shared an (unvetted) story how her daughter suffered "mental retardation" after a Gardasil® injection. (It is important to note that there has been no evidence that there is an association between Gardasil® and cognitive or behavioral disorders.)

The long-abandoned, cringe-inspiring term, "mental retardation," was enough on its own to invite a backlash. Unfortunately, too many journalists focused on the moment's "gotcha" than the broader truths about the drug.

As a result, we the American public are no better informed of Gardasil®'s risks, benefits or effectiveness than before. Equally bothersome: Many of our favorite TV docs piped in to assure us that 35 million doses is proof Gardasil® must be okay. Sadly, I believe that the current debate is still a farce.

What I Found Today On The Website Of The Centers For Disease Control

The CDC manages something called The Vaccine Adverse Event Reporting System (VAERS) which is supposed to serve as an early warning system to help the CDC and FDA detect possible side effects after vaccinations, or adverse events not identified during clinical trials. The public, including vaccine recipients, parents, other family members, doctors, health-care workers -- even vaccine manufacturers -- are all encouraged to report online.

This is what's currently online about Gardasil® :


Reports to VAERS Following Gardasil®
As of June 22, 2011, approximately 35 million doses of Gardasil® were distributed in the U.S. and VAERS received a total of 18,727 reports of adverse events following Gardasil® vaccination ... 8 percent were considered serious.

Deaths

As of June 22, 2011 there have been a total 68 VAERS reports of death among those who have received Gardasil®. There were 54 reports among females, three were among males and 11 were reports of unknown gender. Thirty-two of the total death reports have been confirmed and 36 remain unconfirmed due to no identifiable patient information in the report such as a name and contact information to confirm the report. A death report is confirmed (verified) after a medical doctor reviews the report and any associated records. In the 32 reports confirmed, there was no unusual pattern or clustering to the deaths that would suggest that they were caused by the vaccine and some reports indicated a cause of death unrelated to vaccination.

Merck maintains Gardasil® is safe and effective, and the illnesses and injuries reported to VAERS are consistent with what you would find in a general population of girls that age.

The American Academy of Pediatrics reiterated their support for Gardasil® last week calling its safety record after 35 million doses "excellent."

How do they know? The CDC says that VAERS data cannot be used to form any conclusions between the vaccine and any of the 17,000 reports of adverse events; it's not designed to help determine if the adverse event is coincidental or was caused by the vaccination.

One of the biggest critics of VAERS is Diane Harper, one of the original lead researchers for Gardasil®. In 2009, she published an article in the Journal of the American Medical Association (JAMA) revealing most of the adverse reports on VAERS were in fact, get this, supplied by Merck:

The majority of the reports (68 percent) were submitted by the manufacturer (Merck & Co), which the authors say compares with a rate of 40 percent from manufacturers of other vaccines. But for nearly 90 percent of these reports, Merck & Co. would not provide the CDC with any follow-up information to investigate possible statistical causality link. As the authors pointed out in the article, this is unusual behavior for a pharmaceutical company, Dr. Harper comments. During the same reporting period, manufacturers reported only 14.5 percent of the adverse events associated with Menactra (a meningitis vaccine from sanofi pasteur) and only 7.5 percent of the adverse events associated with Adacel (a tetanus, diphtheria, and acellular pertussis booster vaccine from sanofi pasteur), she points out.



"Why would Merck make a concentrated effort at reporting nearly 70 percent of the adverse events for Gardasil if they did not want to control the information?" Dr. Harper comments. "Legislation needs to be enacted to require adverse events reported to pharma to include medical and contact information for potential follow-up by the CDC."

Dr. Harper, who is also professor of medicine at Dartmouth Medical School, says "HPV vaccination is generally safe for most girls or women," but she and her co-authors also call the adverse events reported: "quite significant," noting fainting and blood clots occurred at greater rates than other vaccines and at a higher rate than reported in Gardasil®'s clinical trials. There is also a fair share of reports about Guillaume-Barre syndrome, but again, with little or no follow-up.

VAERS doesn't exactly promote transparency. If you're looking on their site to find the most recent reports of side effects in 2011, this is what you'll see:

415263,HPV4,MERCK & CO. INC.,0644Z,1,IM,LA,HPV (GARDASIL)

416885,HPV4,MERCK & CO. INC.,0992Z,0,IM,LA,HPV (GARDASIL)
416898,HPV4,MERCK & CO. INC.,1437Z,0,IM,RA,HPV (GARDASIL)
417329,HPV4,MERCK & CO. INC.,1099Y,1,IM,UN,HPV (GARDASIL)

If you want more details, you'll have to file under the Freedom of Information Act as did the consumer watchdog group, Judicial Watch. Here is what one individual case looks like, part of the larger report they published in 2008:


FDA Freedom of Information Distribution

Case received from the Health Authority on 17-JUN-2009 under the reference number PEI 2009012220. The original reporting was done by an alternative healer (non-medical practitioner). It was reported that a 12-year-old female patient was vaccinated with a first dose of GARDASIL (lot # 1050U, batch # NH32130, IM, injection site not reported) on 09-JAN-2009. One day post vaccination the patient developed asthenia, headache and sleepiness which improved the following day. A few days later symptoms recurred and subsequently worsened. Pediatric, neurological and cardiac examinations were carried out and a mild pericardial effusion was diagnosed. Three weeks post vaccination the patient was very weak especially gait, posture and the left arm more than the right arm. GUILLAIN-BARRE syndrome was suspected. At the time of reporting to Health Authority on 25-FEB-2009 the patient had not recovered. Health Authority coded also myasthenia. GUILLAIN-BARRE syndrome, asthenia, headache, sleepiness and pericardial effusion were reported as other important medical event. Other business partner numbers include E2009-05040. No further information is available. File closed.

No Conditions, Not Serious

Not serious? No further information available?

Judicial Watch uncovered a half a dozen cases of Guillane-Barre syndrome plus reports containing symptoms such as "anaphylactic shock," "foaming at mouth," "grand mal convulsion," "coma" and "now paralyzed. "

The document also reveals the case of an 18-year-old woman who was vaccinated with Gardasil, found unconscious that evening and died. Another woman, 19, was vaccinated and then found dead in her bed the next morning.

Before We Argue "Is It Safe?" Shouldn't We Know If It's Effective?

The Gardasil® package warns the protection of the vaccine "may wear off." A document on their website "prescribing information" was updated in April to add: "Vaccination with GARDASIL® may not result in protection in all vaccine recipients."

Why don't they know for sure?

The drug barreled through the FDA for approval in a record six months, before it could be tracked for five or 10 years like most vaccines. It is likely that boosters for Gardasil® will be needed every seven to 10 years as do most aluminum-based vaccines, like Gardasil®. This certainly adds to the cost which, in some areas, already reaches $1,000 for the three doses prescribed.

Is Gardasil® Even Necessary?

I, for one, have come to believe Gardasil® has never been about great health care, it's about great marketing. In 2008, Merck's Gardasil® team swept the Pharma industry awards winning honors for Best Branded TV, Best Branded Print and Best Integrated Campaign.

Merck was also named Marketer of the Year at the awards show. Agency of the Year went to DDB, whose New York office handles consumer advertising for the Merck HPV vaccine.

The award-winning commercials flooded the market, often appearing in high-profile films like "Sex & the City."

Another part of the marketing campaign, lower profile but just as aggressive, included recruiting and training of hundreds of doctors to give talks about Gardasil® for $4,500 for a lecture, with some earning hundreds of thousands of dollars.

Politicians were wined and dined, lobbied to legislate against this global killer. And former state officials, such as Texas Governor Rick Perry's chief of staff, were recruited to lobby former colleagues.

At the time of the Gardasil® roll out, I wondered why the sudden hysteria about cervical cancer -- one of the slowest growing cancers, and certainly among the easiest to detect with an annual pap smear.

Even if you have a false negative one year, next year's pap test will catch it in plenty of time as it takes those abnormal cells about a decade to turn into cancer. I have many friends whose abnormal cells were scraped, lasered or frozen into oblivion after a simple pap test.

But suddenly, with the marketing of Gardasil®, I believe that cervical cancer became a new generation's boogie man.

We learned that the human papollomavirus (HPV), strains of which can cause cervical cancer, affects 75 to 80 percent of sexually active men and women during their lifetime, although most clears on its own.

And we heard this scary statistic resonating throughout the Gardasil® marketing campaigns: Cervical cancer is the second top cancer killer of women.

The reality check: 95 percent of women who die of cervical cancer live in developing countries without access to the pap smears (and in countries where the cost of an HPV vaccine would be prohibitive.) In the U.S. there are about 3,600 deaths a year, many in concert with HIV infections.

Cervical cancer in America does not even rank in the top 10 deadliest cancers.

After the 2008 NYT expose, the chairman of Merck wrote a letter to the editor arguing that the paper minimized the risks of HPV which, he re-emphasized, kills 10 American women a day. He also asked why not one quote was offered from a cervical cancer survivor, widower or motherless child.

Maybe they couldn't find anyone willing to join Merck's marketing campaign. You see, Gardasil® does not prevent cervical cancer. When it is effective, the vaccine prevents the transmission of certain strains of the human papillomavirus (HPV), strains which cause 70 percent of cervical cancer.

Just 70 percent? Yes, women are still advised to get annual an annual pap smear regardless of having the vaccine.

New Competition, New Applications, Old Marketing Strategies

Besides Merck & Company, GlaxoSmithKline markets its own HPV vaccine, Cervarix®. Last month, the National Institutes of Health reported the results of a study of more than 4,000 women in Costa Rica between 18 and 25 who were given the drug and followed for four years. Press releases said Cevarix prevented 62 percent of anal cancers and 77 percent of cervical cancers caused by HPV infection compared with rates in the general population. Headlines focused on the success fighting anal cancer.

The FDA recently approved Gardasil® to also be marketed for prevention of anal cancer, a cancer even more rare than cervical cancer with just over 5,000 cases diagnosed each year. And again, a pap test is often used to detect anal cancer.

Today, you can follow the spread of marketing for the HPV vaccines, specifically with the increasing amount of people suggesting the HPV vaccines for boys.

As a side note, the cost of a mass HPV vaccination project just for girls is estimated to equal the entire budget for vaccinating Americans for measles, influenza, polio and other life-threatening diseases that can turn into an epidemic by the most passive exposure -- sneezing on a bus, wading in a public pool, sitting in a classroom.

On a personal note: I am not against vaccines and was among the first to spot the British wacko who falsified his scientific data and scared the world about a link to autism. I get flu vaccines every October and many other vaccines as recommended. With that disclosure, I issue this appeal to all anchors, political reporters and TV docs who have missed the real story about Gardasil in 2008 and now:

Please don't move on so fast after the fun of a candidate's misstatements. Wake up and smell the coffee, then click on to any one of these YouTube links and take a peek at the postings of some mothers, random health care workers and a bunch of young girls who, after all, are the ones bearing all the risks.

This column was first posted on Shelley Ross' daily Xpress

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