Gardasil: A case study of what can happen when pharma hustling goes wild

While the corporate media has rushed to defend Merck’s profit nub – Gardasil – against Michelle Bachmann - its critique missed the central point about the HPV vaccine: it was not the efficacy of the vaccine that was at issue but whether politicians should be mandating its use at a time when the medical profession was only recommending it for certain age groups. While the cause of this political leap is less clear in DC, it seems evident that Texas Governor Perry was influenced by contributions from Merck. Notice in the stories that follow no medical recommendation that the vaccine’s use be mandated.

As we wrote at the time a bill for mandatory use was introduced in DC:

||| The issue here is not whether the vaccine would work for many; the issue is the wisdom of requiring by law the use of a pharmaceutical that has only just come on the market and for which, for example, even the maker doesn't know its effect on women who take it around the time of conception. The true effects of a drug are often not realized until it's been on the market for some time. And the pharmaceutical industry has a dismal record - from indifference to outright fraud - on policing itself. Mind you, we're talking about a drug that will need to be taken in three $120 a shot doses. Consider that to this day that most people have little idea of the danger of memory loss with statins and that it took years of young people taking anti-depressants before research showed a connection with suicides. The wise move here is to provide but not require until we know much more. As the Washington Post reported, ‘Although the American Academy of Pediatrics recommends the vaccine for all girls ages 11 and 12, an adviser to the academy said he thought it was premature to recommend making it mandatory. 'I think it's too early,' said Joseph A. Bocchini, who chairs the academy's committee on infectious diseases. 'This is a new vaccine. It would be wise to wait until we have additional information about the safety of the vaccine.'” ||||

ABC News - Perry took issue with Bachmann’s accusation that his decision was spurred by the prospect of cash pouring into his campaign fund from the drug company. . . Perry cited a $5,000 campaign donation from Merck, but according to records from the Merck PAC, Perry has received nearly $30,000 in donations from the drug company over his decade as governor of Texas. The $5,000 Perry referred to was merely the Merck donation from 2006, one year before he established the executive order.

Health Research Group – Perry’s former chief of staff Mike Toomey has found a new (and presumably more lucrative) lease on life with Merck, manufacturer of the HPV vaccine Gardasil. And on the very day that Perry’s staff met with Merck about the Executive Order, a $5,000 check from the company made its way into the governor’s coffers. Add to that Merck funding of a group of female state legislators called Women in Government, many of whom introduced mandatory vaccination bills in their respective states, and you have all the ingredients for a sordid political stew.

But just because self-interested corporate behavior is at the root of an initiative does not prove that the initiative is not worthwhile. Cervical cancer takes the lives of some 3,700 American women each year. Preventing these deaths is obviously an end worth pursuing. . .

We certainly agree that the lobbying for this product has been unseemly. In its greed to maximize profit and its desire to gain a solid foothold before another HPV vaccine is approved, as is expected, Merck opted for the hard sell. It is unusual for a vaccine to be mandated so early in its lifespan. A better course would have been to wait for more safety data to accumulate and then sell the vaccine on its scientific merits, rather than by heavy-handed lobbying.

We recommend that people wait seven years unless the new product is a breakthrough of some kind. As there is no vaccine or medication proven to prevent infection with HPV, and because young people often become infected soon after becoming sexually active, we recommend not waiting the seven years in this case.

It’s true that the studies were funded by Merck itself, but this is standard practice in the drug and vaccine industries. We have advocated that drug companies be required to pay into a pool and that neutral scientists should conduct and analyze drug and vaccine studies. But until this proposal is accepted, most studies of new products will be conducted by their sponsors. While this should always make one skeptical of the results reported, one cannot simply dismiss studies solely on the basis of who is their sponsor. To do so would lead to refusing to take almost all drugs.

Studies of the vaccine show that toxicity was limited, usually restricted to pain and tenderness at the injection site (84 percent and 25 percent respectively). There are, however, few data on long-term toxicity due to the limited length of the trials conducted. This leaves many questions unanswered. The FDA recommends against use in pregnant women, though there is no evidence that it is toxic to the developing fetus

NY Times, 2011 - The vaccine is strongly recommended by medical groups, including the American Academy of Pediatrics and the American Cancer Society, to prevent cervical cancer, which kills about 4,000 women in the United States annually.

The recommended age of vaccination for girls is 11 or 12, before they become sexually active. But only Virginia and the District of Columbia require vaccination for middle school entry, according to the cancer society.

Dr. Deborah Saslow, the group’s director of breast and gynecological cancer, said it did not advocate requiring HPV vaccinations before entering middle school, since parents and even doctors need more time to get used to the idea of the vaccine and to accept that it is safe.

ABC News - Currently, the Centers for Disease Control and Prevention suggest that doctors "strongly recommend" that all 11- or 12-year-old girls be vaccinated against HPV, which is the cause of almost all cases of cervical cancer. The vaccine is a series of three shots, and is approved for use in males and females from ages 9 to 26.

Dr. William Meadow, a pediatrician and medical ethicist at the University of Chicago, said a doctor's strong recommendation to vaccinate a child often is all the prodding that many parents need. "Most pediatricians should and do recommend the HPV vaccine, and most parents of young women choose to have their child vaccinated," Meadow said. "What's the advantage of forcing someone to do it?"

Progress Report, 2008 - In July, U.S. Citizenship and Immigration Services quietly amended its list of required vaccinations for immigrants applying to become citizens. One of the newest requirements was Gardasil, which vaccinates against the human papillomavirus, the most common sexually transmitted viral infection in the United States. The problem with this regulation is that the HPV vaccine is not mandatory for U.S. citizens. Therefore, U.S. citizens are allowed to weigh the costs and risks associated with Gardasil, but immigrants are forced to pay-out-of-pocket for a vaccine they might not want to take. Without health insurance, the three-shot vaccine can cost $162 per dose, making it the most expensive vaccine on the market. "Given Gardasil's high cost, and the fact that there does not seem to be a public health justification for this particular mandate, I'm concerned that its real purpose is to create a financial barrier for immigrant women who seek to lawfully enter this country," said Jessica Arons of the Center for American Progress.

CBS, 2009 - Amid questions about the safety of the HPV vaccine Gardasil one of the lead researchers for the Merck drug is speaking out about its risks, benefits and aggressive marketing. Dr. Diane Harper says young girls and their parents should receive more complete warnings before receiving the vaccine to prevent cervical cancer. Dr. Harper helped design and carry out the Phase II and Phase III safety and effectiveness studies to get Gardasil approved, and authored many of the published, scholarly papers about it. She has been a paid speaker and consultant to Merck. It’s highly unusual for a researcher to publicly criticize a medicine or vaccine she helped get approved. Dr. Harper joins a number of consumer watchdogs, vaccine safety advocates, and parents who question the vaccine’s risk-versus-benefit profile. She says data available for Gardasil shows that it lasts five years; there is no data showing that it remains effective beyond five years. . . .

Asantewaa Nkrumah-Ture, Testimony before DC City Council - I am not personally advocating against the HPV vaccine; I'm strongly advocating that we all ask questions and demand all of our questions and concerns be addressed to our satisfaction. . . The following questions must be asked:

- Does the vaccine Gardasil prevent all types of cervical cancer? If not, which ones will it prevent? Does the vaccine protect against the most common types of cervical cancer here in the USA? If the leading killer of women in the USA is heart disease and not breast or cervical cancer, why is this vaccine being made "mandatory"?

- New Jersey-based Merck Co. makes this vaccine and its questionable ties to politicians and others has now come to light. . . Billions of dollars can be made by the drug company; the three required doses cost $360, and of course, the drug company is aggressively pushing for the vaccine to be "mandatory."

- Who is held liable in the case of mild or severe adverse effects or allergic reactions? . . . How many years of study on possible adverse effects has been done and documented?

- How do you "opt out" and who is responsible for explaining this process? Is it a time consuming process? Are there any penalties for opting out?

- If a young girl's parent [or] guardian is in jail, prison or a mental institution, do such parents [or] guardians give up their right to give consent for this vaccine? Who will advise such parents [or] guardians of their legal rights?

- Has Merck and Co. had any type of contact with any members of our City Council, their staff members, our city's Department of Health, their staff members or any other city officials? Has this drug company had any contact with any of our city's community leaders or other health care professionals?

- Cervical cancer and HIV - AIDS are both caused by a virus. Why are some people trying to make the HPV vaccine "mandatory" and not mandatory testing for HIV - AIDS, especially in a city like Washington, DC with its ever increasing HIV - AIDS rate, especially among women? Since DC General Hospital is now closed, where do you go to get the vaccine? Community clinics? Planned Parenthood? Your private doctor's office?

- The obvious race, class and gender aspects of this issue cannot be overlooked. Why didn't the HPV vaccine proponents do the kind of research of community opinion and carefully plan educational programs to answer any and all questions and concerns parents and the general public may have? . . .

- Why not make high quality public schools, equipment, supplies and infrastructure "mandatory"; comprehensive, science-based human sexuality education; affordable health care; health insurance; living-wage jobs; domestic violence, sexual assault and violence prevention education; high school and post-high school vocational education; substance abuse prevention education, etc. Why must African people, women, people of color and other marginalized groups of people, our bodies, be made guinea pigs for the benefit and advancement of science?

Rita Rubin, USA Today, 2007 – The American Academy of Family Physicians on Feb. 7 issued a policy statement that said it was "premature" to consider requiring immunization for school entry. "Long-term safety with widespread use, stability of supply and economic issues" must be clarified first, the statement said. . .

Gregory Lopes And Christopher M. Dolan, Washington Times - Lawmakers looking to force preteen girls to take Gardasil, a new vaccine against a virus that causes cervical cancer, are targeting the wrong age group, cancer data shows. Middle-school girls inoculated with the breakthrough vaccine will be no older than 18 when they pass Gardasil's five-year window of proven effectiveness -- more than a decade before the typical cancer patient contracts the sexually transmitted human papillomavirus.

Infectious disease specialists and cancer pathologists say the incubation period for HPV becoming cancer is 10 to 15 years -- meaning the average cervical cancer patient, who is 47, contracted the virus in her 30s and would not be protected by Gardasil taken as a teen. "It is a delicate balancing act," said Debbie Saslow, director of breast and cervical cancer control at the American Cancer Society. "If the vaccine is given at too young an age, it may wear off. Yet if it is given too late, it won't work.". . .

Progressive Review City Desk - We noted the other day the foolishness of DC requiring young girls to take a vaccine to prevent cervical cancer before there was an adequate history on the drug. The vaccine in question is made by Merck and now we read in the Online Journal: "Let no one say the studies in JAMA are funded by hidden drug company money. The funding is right out in the open. 'Effects of Continuing or Stopping Alendronate After 5 Years of Treatment,' in the December 27, 2006, issue of JAMA was funded by Merck that manufactures alendronate, a bisphosphonate, under the patent name Fosamax. Not only was the study 'supported by contracts with Merck and Co.,' according to JAMA, it 'was designed jointly by the non-Merck investigators and Merck employees' and written 'with editorial input from Merck throughout the process.' Want further transparency? 'The final version of the manuscript was approved by all coauthors, including Merck authors,' says JAMA.

Sarah Boseley, Guardian, UK, 2007- A campaign fronted by doctors and celebrities to persuade European governments, including the UK, to vaccinate all young girls against cervical cancer is being entirely funded by the drug company that markets the vaccine.

Sanofi Pasteur MSD, which markets Gardasil in Europe on behalf of the drug giant Merck, spent millions on what was billed as the "first global summit against cervical cancer", held in Paris on Thursday with doctors and patient organizations from across Europe.

The revelation comes as public health experts express disquiet about the promotion of a vaccine that is only effective in young girls - possibly at the expense of screening programs that are essential to protect adults. They also worry that the long-term effects of the vaccine are not known. The vaccine protects against the most common strains of the sexually-transmitted human papilloma virus (HPV) which causes cervical cancer.

Pharmalot, 2007 - A recent three-day event at the University of Chicago campus was held to promote awareness of HPV and the new vaccine everyone has been talking about. And it was co-sponsored by Peer Health Educators, a student program, and three companies: Sony, Avon and Merck.

One day, there were free makeovers. Another brought live music. And there was a day devoted just to discussing men's health. "We felt that it's very rare that there's a men's health event on campus. We wanted to bring men's health into a seemingly women-specific issue," Colleen Christensen, a second-year Peer Health Educator, tells the Chicago Maroon, the school newspaper.

Not only were free coffee and t-shirts given away, so were little bags of peanuts labeled with instructions on how to give 'self-testicular exams.' Peanuts? Why not beer bottles? Anyway, here's the message young men: One day, you won't have to worry that your short and curlies are sporting warts or growing harmful cells if the Merck vaccine is approved for fellas like you.

A similar event is being held at Ohio State University as part of a pilot program, and Merck plans to sponsor the same thing at 20 other universities this fall. By the time Merck convinces the FDA to approve Gardasil For Guys, a whole generation of educated young men will be primed for a shot. And they'll no longer have to associate peanuts with tricky maneuvers.

Kaiser, 2007 - Some health insurance companies are not covering Merck's human papillomavirus vaccine Gardasil and others only cover part of the vaccine's cost, the Detroit News reports. According to the News, many physician offices are requiring patients to pay for Gardasil up front or sign a waiver stating they will pay for the vaccine if their insurance company does not. . . According to some Detroit-area physicians, the full cost of the vaccine, which is given in three injections during a six-month period, is about $450. Two of the largest insurance providers in southeast Michigan, Health Alliance Plan and Blue Cross Blue Shield of Michigan, provide coverage for the vaccine. BCBS only pays for the HPV vaccine when the plan has immunization coverage, which is included in most employer groups, an unnamed company spokesperson said. According to the News, some health insurance plans stop immunization coverage at age seven or 17. In addition, some insurance companies that cover Gardasil have annual limits on preventive care that might be lower than the cost of the vaccine. "The insurance issue is a nightmare," April Sarvis, a Bloomfield Hills, Mich.-based ob-gyn, said, adding that some physicians are not offering Gardasil because insurance plans are not paying the full cost