Merck funding and the push to give Gardasil without parents’ knowledge or consent

Well, color me naïve. Last week I wrote here about two ill-advised bills currently attempting to make it legal for clinics and school nurses to give children HPV shots (Merck’s Gardasil is the brand most commonly used in the US)—regardless of age, and without their parents knowing a thing about it.

"Although some bloggers have speculated about the motives of these zealous legislators, particularly with regards to campaign contributions by Merck,” I wrote, “I don’t doubt that they think they’re doing the right thing—even if they’re in fact being preposterously over-reaching.”

Now a regular reader has written to let me know that Senator Liz Krueger is in fact a member of Women in Government, a group that was heavily criticized for attempting to make vaccination with Gardasil mandatory for public school attendance after receiving substantial funding from Merck.

OK, sometimes I’m a real innocent.

Children to be given Gardasil or Cervarix without parents’ knowledge or consent?

Imagine. You brush up against your daughter and she winces; you pull up her sleeve and see the telltale needle mark. She’s what, perhaps 12 years old.

It was Gardasil, not heroin, duh, she says. The nurse said it was safe and now I will never get cervical cancer. Don’t you want me to stay healthy, Mom?

Well, yes. And so, because you know that she has a strong family history of autoimmune disease on both sides, you’ve deliberately chosen to protect her health by avoiding getting her extra shots. Particularly Gardasil, because it’s a novel type of genetically engineered vaccine, as yet unproven, and of questionable value. You’re cautious because it has anecdotally been associated with autoimmune diseases—which are triggered in susceptible individuals by environmental factors—and your doctor has advised you, dammit, to be cautious with shots.

But now your informed decision has been overridden by a complete stranger.

Ridiculous?

If the scenario of a minor child—as young as nine—being given a shot without a parent’s knowledge or consent seems absurd, think again. New York Senate bill S4779, sponsored by Senator Liz Krueger and co-sponsored by Senators Adams and Parker, provided for exactly that. And although S4779 has been held in the Senate Codes Committee for improvement and clarification of the bill's language, Ms. Krueger is reportedly determined to get it through at some point. Meanwhile, Assemblywoman Amy Paulin has sponsored  New York Assembly bill A06702, which is almost identical apart from an attempt to make vaccination with Gardasil mandatory for school attendance.

The bills seek to ensure “that a health care practitioner may provide medical care related to the prevention of a sexually transmissible disease, including administering vaccines, to a person under age eighteen without the consent or knowledge of his or her parents or guardians, provided such person has capacity to consent to the care, without regard to the person's age, and the person consents. The section provides further that any release of patient information regarding vaccines provided under this section shall be consistent with sections 17 and 18 of the public health law.”

Wonderful. Not only could a nurse shoot up my kid with Gardasil or Cervarix even if I’ve specifically decided against it, I couldn’t find out for sure what those needle marks are. I’d have no clue as to why my child might have started convulsing, as did two girls in Spain right after getting their shots.

The whys and wherefores

Although some bloggers have speculated about the motives of these zealous legislators, particularly with regards to campaign contributions by Merck, I don’t doubt that they think they’re doing the right thing—even if they’re in fact being preposterously over-reaching. Merck has done a fantastic job of persuading the public, including (apparently) some legislators, that if our kids don’t get the three Gardasil shots at a total cost of around $400 per child, they’re gonna get cervical cancer. Why bother to research the real facts?

Merck, of course, has notoriously been highly unscrupulous about its sales jobs—from concocting an entire fake medical journal and deliberately discrediting doctors and researchers who questioned Vioxx to paying off professional medical associations (PMAs) to promote Gardasil to other health professionals, without any appropriate transparency and discussion of risks and benefits. Not to mention its participation in the skewing of reporting drug trials endemic in professional journals.

The company is not going to spend a whole lot of effort on educating anyone about the full pros and cons of Gardasil and the truth about HPV. Particularly when its Gardasil sales have just plummeted by almost 80 percent in Australia, where a massive HPV vaccination campaign has ended.

Nor can we rely on doctors to educate themselves and us. In the context of Gardasil, Newsweek even quoted Susan Wood, former head of the FDA’s Office of Women’s Health, as believing that there was no relationship between a healthy diet and a strong immune system that could fight off HPV on its own and leave a natural immunity in its wake—totally contrary to solid scientific evidence.

And so we have legislators falling for the quick fix. Kids are having sex, their theory goes, and indulging in risky behavior. They already come to us to get birth control and treat STDs, so let’s PREVENT the STDs with a very expensive shot that must be safe because the government says so (Vioxx, anyone? BPA? Tambocor? Thalidomide?). It must be effective because Merck says so. Parents, of course, are just naïve, uncaring, and/or prudish and should have no say in the matter.

Never mind that kids who are already having sex have a heightened risk of developing a high-grade cervical abnormality if they are infected with vaccine-type HPV when they get Gardasil—particularly if they smoke.

The capacity to consent

But wait. The target kids have to have the “capacity to consent,” right? They can make decisions for themselves, especially if they’re already having sex, a supposedly adult activity. Gardasil is recommended for kids as young as nine, and kids as young as nine have been known to have sex ‘willingly.’

The capacity to consent implies the ability to understand and weigh all the pros and cons of Gardasil. Frankly, I’ve been giving my DOCTOR info that she, as an overworked professional, didn’t have previously. And yet Ms. Krueger and friends think that a nine year old—hell, a sixteen year old—can sit there and figure it all out before making an informed decision?

I’d think a lot better of Ms. Krueger if she initiated healthier foods in schools. Or campaigns that educated kids about the behaviors that cause persistent HPV infections and, potentially, cancers. I’d be good with efforts to teach parents about Gardasil, honestly cataloging the risks and benefits. I’m not necessarily against Gardasil for the right, most at-risk population as long as their family history is taken into consideration.

But I am totally against usurping parents’ rights, making uninformed decisions, and encouraging kids to make uninformed decisions. Especially when there’s a financial motive on the part of clinics and drug companies.

That’s what cigarette companies do. Is Senator Krueger the new face of the Marlboro Man?

Here’s the straight talk for your kids, just in case legislators nationwide are daft enough to jump on the Krueger bandwagon. What you need to know about Gardasil

Gardasil pros and cons

Gardasil has been hailed as the first vaccine against cancer, protecting women against some of the strains of human papillomavirus. HPV can, in a tiny percentage of cases, cause cervical cancer. Gardasil also been reviled as oversold and potentially dangerous. Here’s what you need to know:

• Up to 80 percent of people will get HPV, a virus akin to the common cold, in their lifetime. There are more than 100 strains of HPV, multiple strains of which COULD cause cancer in limited circumstances.

• 95 percent of those infections are self-limiting—they’ll be beaten off by your immune system, leaving you immune to further infection with the same strain.

• Only if an infection becomes persistent could it cause pre-cancerous lesions.

• Your behavior dramatically affects the chances of an infection becoming persistent.

• If you smoke, you have up to a 2,700 percent greater chance of getting a persistent HPV infection. (Anthony Gunnell, M.A.Sc., Karolinska Institutet, Stockholm; November 2006, Cancer Epidemiology, Biomarkers & Prevention)

• If you don’t eat vegetables and fruit regularly, you are 50 percent more likely to get a persistent HPV infection. (Rebecca L. Sedjo, MSPH, et al: University of Arizona, US; Cancer Epidemiology, Biomarkers & Prevention)

• If you have multiple sexual partners, you will exponentially increase your chances of getting a persistent HPV infection.

• Oral birth control and having sex at a young age may increase HPV risks.

• Being uncircumcised or having an uncircumcised partner increases HPV risks.

• Insufficient sleep on a regular basis, drug use—anything, in fact, that depresses your immune system—will increase your chances of getting a persistent HPV infection.

• With all that, if you get regular Pap smears, the chances of an infection progressing to pre-cancerous lesions and then cervical cancer are very small, and if it does, it is extremely curable when caught early. About 4000 women, some 60 percent of whom have not had smear tests, will die of cervical cancer in the US this year. It is twice as likely to affect Hispanic women and 50 percent more likely to affect African American women, probably because of economic factors. The number of cases drops by about 4 percent annually.

Gardasil
• Gardasil protects against the two strains of HPV, 16 and 18, that currently cause close to 70 percent of cervical cancer, plus two wart-causing strains. There are more than 100 strains of HPV. Merck’s research shows a small degree of cross-protection against strains not covered by the vaccine.

• Gardasil is a novel type of genetically engineered vaccine.

• Although ads imply that you will not get cervical cancer if you get Gardasil, Gardasil does not protect against many oncogenic strains of HPV. So far, Merck’s research has shown a rather meager 17-45 percent reduction in all cervical abnormalities in vaccinated girls. Recent figures of 89 percent reduction refer only to abnormalities and persistent infections caused by the four vaccine-type strains and do not include abnormalities caused by other strains.

• Although HPV16 and 18 caused the majority of invasive cervical cancer in a sample of women in New Mexico, the overall proportion attributable to HPV16 has dropped over 20 years, giving way to non-18 types. (C.M.Wheeler, PhD, University of New Mexico; Journal of the National Cancer Institute 2009).

• There is some concern that non-vaccine HPV types will fill the biological niche, an effect known as replacement disease. Merck does not think this likely, although it has happened with the vaccine Prevnar.

• The effect on natural immunity and duration of protection is currently unknown. Nor is the effect of new HPV infection in older adults when immunity has worn off.

• Merck’s research showed initially that Gardasil caused a 44.6 percent increase in the highest grade of pre-cancerous lesions in women who were already infected with vaccine-type HPV. Merck determined that the study was unbalanced and that those women also had high risk factors such as smoking. After ‘balancing’ the study, the combined figure for subgroup studies showed an enhanced risk of disease of 11.7 percent for females who had vaccine-type HPV at the start of the study.

• If you are already sexually active, get an HPV test prior to vaccination, particularly if you smoke or are otherwise high-risk.

• A neurologist has expressed concern about unusual immune response-mediated inflammation in the spine of a girl who died from an unusually rapid onset ALS-type disease and believes it may be associated with Gardasil.

• The FDA associates Gardasil with heightened risks of syncope and blood clots.

• Gardasil has also been associated anecdotally with Graves Disease, paralysis, Guillaine-Barré syndrome, seizures, chronic headache, and various autoimmune diseases although not at statistically extraordinary levels. Merck’s studies showed a slightly elevated risk of various types of arthritis. Incidence of autoimmune disease, which is triggered in susceptible people by environmental factors, is rising rapidly and an ever-increasing lifetime burden of vaccines and accompanying adjuvants may be a factor. This has not been proven, however. In trials of Gardasil, placebo vaccinations used an aluminum-containing adjuvant, something that could mask sideeffects.

• You should still get regular Pap tests, even if you have been inoculated with Gardasil.

It’s important to honestly assess your family medical history and lifestyle prior to getting the course of vaccinations. Read up on the facts. Gardasil may well be right for you, but it is not 100 percent effective or safe. Know its limitations—and yours.

Merck looks to expand $400 Gardasil use while scientists say a $2 test could prevent 100,000 deaths from cervical cancer

Maybe it’s just me. But I found it extraordinarily offensive that on the same day that scientists in Britain reported that 100,000 deaths from cervical cancer could be prevented annually by the use of a $2 test overseas, reports surfaced that Merck is once again trying to get approval for Gardasil (cost: $360 per person, plus whatever health care providers charge for administering it) to be used for women aged 27-45.

The difference is, of course, that expensive Gardasil will be used in the US, where it is least needed. Although at least 80 percent of women here will be infected by the HPV virus, 95 percent of those infections will be shrugged off by healthy immune systems, leaving in their wake a natural immunity to further infection. Of the small percentage of cases that become persistent, many could be avoided by eating a healthy diet with fruits and vegetables, quitting smoking, getting enough sleep, limiting sexual partners, etc. And most (granted, not all) persistent HPV infections that do turn to cancer can be caught early by regular screening.

Still, an incredibly effective marketing scheme that fails utterly to accurately inform women about the pros and cons of the vaccine has convinced women that unless they pony up big bucks they’re going to get cervical cancer.

Now Merck, dismayed by flagging sales and by clear evidence that Gardasil isn’t cost-effective for the potentially lucrative male market and its recommendation only as a wart-preventer and not as a cancer preventative for boys, is once again going after the older women market. It will be interesting to see whether they have found a way around earlier evidence that Gardasil may actually cause existing HPV infections to become cancerous.

Meanwhile, in developing countries, where women often aren’t able to get regular life-saving Pap smears and equally often have depleted immune systems due to inadequate diet—countries where Gardasil would actually make sense—a simple, dirt-cheap test could really, truly save lives. It can be used in rural areas without sophisticated equipment and labs; a nurse, midwife, or OB/GYN simply swipes the patient's cervix with acetic acid (vinegar) and then looks at the tissue. If lesions are present, the tissue turns white.

The only obstacles? Raising awareness, and getting enough money and qualified people to do the $2 tests and follow-up. Without, of course, a fraction of the budget that Merck has used to sell the largely unnecessary Gardasil vaccine.

So once again, I’m telling Blue Cross/Blue Shield: thanks for offering my girls the vaccine, but please send the $800 to an appropriate charity that offers VIA screenings to women in developing countries instead. Hey, that’s 400 potentially life-saving tests. Doesn’t that sound more cost-effective than inoculating two very low-risk girls?

Gardasil Optional, Not Recommended, for Boys--Will You Pay for It?

It’s up to you now. The Advisory Committee on Immunization Practices voted almost unanimously to tell doctors that they’re free to give boys the Gardasil vaccine as a way of avoiding future bouts with genital warts—which affect about one percent of the population—but they’re not going to recommend it as a routine vaccination.

Nor do they plan to recommend it as an “anti-cancer” vaccine, which is the way it’s been sold to many millions of girls. Although the HPV virus can cause esophageal, anal, testicular, penile and perineal cancer in boys, such cancers are very rare, and even then a large percentage aren’t associated with the human papillomavirus. The only real advantage would be to protect future partners.

Merck, with billions on the line, had determined that the vaccine would be very cost-effective for boys by assuming that the vaccine would be 100 percent effective in preventing cancer and that the vaccine would cost $400 per child—at $360 for the cost of the shots alone, that doesn’t leave much to pay the cost of three visits to the doctor.

A Harvard study, however, went on the assumption that the vaccine would be 75 percent effective and cost $500 per child, and found that the cost of vaccinating boys would be spectacularly cost-ineffective.

The Advisory Committee apparently agreed with Harvard.
There is certainly no reason to assume that Gardasil will be 100 percent effective. Merck’s own study of more than 4,000 boys didn’t even find that, and Gardasil trials have shown the HPV vaccine to be just 17-45 percent effective in preventing cervical abnormalities in girls thus far. Gardasil has also been associated anecdotally with a number of rare, but serious, side effects, including autoimmune diseases and a form of ALS.

Meanwhile, it’s doubtful that many insurance companies will now pay for Gardasil for boys, although government programs may do so for those on Medicaid. Parents might prefer to be sure that their children understand the importance of getting annual exams as adults and of eating fruits and vegetables, avoiding smoking, being circumcised, getting sufficient sleep, and limiting the number of sexual partners—all factors that are known to substantially cut the risk of getting a persistent HPV infection.

So are you willing to fork over the cash yourself? Do you think Gardasil’s worth it?

Is There a Gardasil / ALS Connection?

All it would take is for neurologists to ask young female patients—and soon, young men too—a simple question.

“You have symptoms of ALS. Did you have the Gardasil vaccination?”

That’s the only way that we’re going to eventually find out whether the unusually rapid-onset ALS-like paralysis that killed Jenny Tetlock and Whitney Baird was indeed related to their recent vaccinations with Gardasil.

Up until now, no-one’s been asking. Most parents take routine vaccinations for granted and don’t think to bring it up. Merck and the FDA insist there’s no link. But at the 134th meeting of the American Neurological Association, Catherine Lomen-Hoerth, MD, director of the ALS Center at University of California San Francisco Medical Center, was asking.

Jenny Tetlock died from a neurological disease, mediated by immune responses, which led to extensive damage in her spinal cord. Lomen-Hoerth noted the unusual inflammation in Jenny’s spine and announced that she and her team are planning to study girls with ALS, both those who got the vaccination and those who didn’t, to compare symptoms and pathological features.

Hopefully, neurologists will now start asking about Gardasil—so simple!—and perhaps even comb through the records of any current and deceased patients with juvenile ALS, and then send the information on to Lomen-Hoerth.  It won't just be Jenny's parents who are saying, look, maybe there's no connection, but we want to know for sure.

And it’s not at all irrational to ask that question. Right now, there’s no causal link established between Gardasil and ALS, and two cases among millions of girls safely inoculated with the HPV vaccine means zip. However, given the unusual spinal inflammation (not a hallmark of ALS) and Jenny and Whitney’s shared history of a childhood autoimmune skin disorder that might have made them more vulnerable; given that periods of paralysis have marked mystery post-Gardasil medical conditions in a number of girls—given all that, there’s good reason to ask the question seriously.

Dr. Diane Harper Badly Misquoted on Gardasil and Cervarix

I’m not a regular reader of the Guardian’s “woo-medicine”-debunking columnist Ben Goldacre, and when I do read him I often disagree with him.

But he hit a home run with his latest Bad Science column.

He took apart a front page Sunday Express article that has already been widely disseminated around scare sites on the Internet. Of course, you can’t read it on the Sunday Express site anymore because it's been removed. Probably because Dr Diane Harper, who was quoted as saying that HPV vaccines are more dangerous than cervical cancer, is about to sue the pin-striped pants off the always-lurid Express. Or so I hope.

I’ve often felt sorry for Dr Harper. She seems like a forthright, intelligent scientist who removes herself from Merck’s marketing hysteria to make sensible cautionary comments about the Gardasil vaccine, which she has worked on and in general supports. But her comments are frequently taken out of context and paraded around the web as if she were an anti-vaccine crusader.

As someone who is wary of Gardasil to the point of thus far turning it down for my daughters, who have a family history of autoimmune disease; as someone who would like to see an awful lot of very serious questions about Gardasil taken very seriously and answered very seriously, it makes me LIVID. We need more people in the pharmaceutical industry to encourage scientists, physicians and the public to ask intelligent questions and not simply swallow the party line wholesale. So-called reporters like the notorious Express’s Lucy Johnston badly undermine the likelihood of that happening.

If I’ve understood Dr. Harper correctly—forgive me if I haven’t, Dr. Harper, and feel free to correct me—she thinks that HPV vaccines are in general a good thing but that Gardasil should have been introduced more slowly and cautiously; and that perhaps people with family histories of auto-immune disorders should be particularly cautious. She thinks—again, if I understand correctly—that Merck’s unprecedented intensive marketing campaign has oversold Gardasil; that the 3-shot series and its marketing might make women cavalier about still-essential annual exams; that we don’t know how long protection will last.

According to Goldacre, what she doesn’t think is what she was reported as saying in the Express’s article. That the cervical cancer vaccine 'may be riskier and more deadly than the cancer it is designed to prevent.' That the jab 'would do nothing to reduce the rates of cervical cancer in the UK.' Etc., etc., etc.
Goldacre simply contacted Harper directly when he read the article.

“I will explain Harper's position in her own words,” he writes. “They are unambiguous: ‘I did not say that Cervarix was as deadly as cervical cancer. I did not say that Cervarix could be riskier or more deadly than cervical cancer. I did not say that Cervarix was controversial, I stated that Cervarix is not a 'controversial drug'. I did not 'hit out' – I was contacted by the press for facts. And this was not an exclusive interview.”

Harper did not "develop Cervarix" but she did work on some important trials of Gardasil and also Cervarix. "Gardasil is not a 'sister vaccine' as the Express said, it is a different compound. I do not know of the side effects of Cervarix as it is not available in the US.’

“She did not say that Cervarix was being overmarketed. ‘I did say that Merck was egregiously overmarketing Gardasil in the US – but Gardasil and Cervarix are not the same vaccines’…She also suspects from modelling data that for the specific and restricted group of women who are punctilious about attending every single one of their cervical cancer screening appointments, vaccination may have little impact on their risk of death from cancer; but even they will benefit from the reduction in reproductive problems caused by treating pre-cancerous changes in cervical cells.

‘I fully support the HPV vaccines," she says. "I believe that in general they are safe in most women. I told the Express all of this.’”

That was a lot of Goldacre’s column to reproduce. But I think it bears repeating as long as the Sunday Express article inevitably circulates and spawns more mis-information.