Bonus Lobbying Victory: European regulators give Gardasil nod for use in women up to the age of 45

Last week was good to Merck’s hopes for an improved bottom line next quarter. It was a very a disappointing week for those of us who feel the HPV vaccine has the potential to do more harm than good, and continues to preempt scarce public health funds better used for more effective programs, like universal access to PAP Tests.

Merck’s FDA and European Gardasil market-expansion victory was some what muted by its potential competitor, GSK’s Cervarix own good news as it inches  closer to FDA approval. Merck has used all of its Federal regulatory lobbying influence to delay FDA approval of Cervarix for the American market.

Merck actively sought new indications for Gardasil to help combat falling sales of their human papillomavirus shot

Merck’s Garasil vaccine, promoted to prevent cervical cancer and genital warts, roared onto the market in 2006, but since then has decelerated sharply. Merck has been lobbying to increase its potential market to boys and mature women. It failed to persuade FDA to broaden use to older women–up to the age of 45–but now has convinced an agency advisory committee that Gardasil would be useful for boys and young men.

A few panelists–and at least one analyst–point out that approval for use in males doesn’t necessarily mean males will use it. The series of three shots is expensive, around $400, and will require three visits to the doctor over a six-month period…to prevent a nonfatal venereal disease. “Pretty much no healthy teen would ever do that,” Tim Anderson, analyst with Sanford C. Bernstein, told the New York Times.  (Good point Tim. The more cynical amongst those of us, who have fought use of Garasil  since the beginning, are wondering if, even now, the Merck marketing team is not trying to whip up false scare tactics that will herd fathers into take their sons in to doctor’s offices in massive numbers — after all, those catchy, cute commercials worked to move hundreds of thousands of well meaning mothers to contribute to those fat bonuses Merck Execs passed out in 2006 and 2007.)

Merck is expected to argue for vaccination of boys and young men in part to help protect girls and young women. But it remains to be seen whether that “herd immunity” argument will work on parents and insurers who have to pay for the shot.

The European approval, meanwhile, addresses cervical cancer, which is potentially fatal. [Sandi note: Merck's phasing, not mine. Cervical cancer is potentially, but rarely fatal if women have regular PAP tests after they become sexually active.] In Europe, the vaccine is marketed by Sanofi Pasteur MSD, a joint venture between Merck and Sanofi-Aventis. European regulators gave the nod to expand use of Gardasil to women up to age 45, when previously it was only indicated for those up to age 26.

This new expansion gambit is a complete mystery. In 2006 the rational used by Merck lobbyists for vaccinating school-girls as young as age 10 was that the HPV-vaccine Gardasil was not effective once the girls were exposed to HPV via sexual activity. Hundreds of thousand of girls have been herded into doctor’s offices by mothers and State regulators on the promise of lifetime protection from cervical cancer.  As more non-marketing information became available, questions that should have been asked and answered BEFORE approval began to be discussed. Dr. Diane Harper, one of the designers of the early trials, questioned the long-term effectiveness of the vaccine and raised the possibility of booster shots needed just at the age when young women became sexually active.  Based on Merck rational for expanding Gardasil usage for women up to their mid-forties, why do we continue to put young girls at risk with a vaccine with a history of adverse effects and has been tied to the deaths of young healthy girls.

In the U.S., the FDA has asked Merck for more data on Gardasil use in women 27 to 45 years old; the company expects to provide that info by the end of this year. Mother’s need to watch this like hawks. Read the FDA rational and the Merck aguments for expansion.  The money spent enriching Merck executives is far better used expanding access to PAP tests.

Sources:

Read Full NYT story: Two Giants Vie for Billions in S.T.D. Vaccine Market:

Read Full Story from CNNHealth.com: FDA panel urges HPV vaccine be given to boys

Read Wall Street Journal article: FDA Panel Backs Cancer Vaccines

©2012 An Inconvenient Woman. All Rights Reserved.

- The product information of the four-type (6,11,16,18) human papillomavirus (HPV) vaccine Gardasil® has been updated to include the clinical efficacy and safety information of the vaccine for women up to 45 years of age.*,1

In a clinical study which included 3,819† women between 24 and 45 years of age, among those who were not infected with the relevant virus type at vaccination‡ and who received all three doses of the vaccine (3,351 women§, Gardasil® prevented 90.5%** of HPV 6-, 11-, 16-, or 18-related persistent infection, cervical lesions (CIN††) of any grade, adenocarcinoma in situ (AIS), cervical cancer, vulvar and vaginal lesions and genital warts.1,2

Gardasil® was generally well tolerated and demonstrated a good safety profile with fever as well as redness, swelling and pain at the injection site as the most commonly reported side effects.1,2

“Vaccination recommendations or campaigns from health authorities will continue to focus on adolescent girls. However, women may remain at risk of HPV infection and developing related diseases during their adult life. Women should be aware of the efficacy and safety of Gardasil® up to 45 years. They should make an informed decision about individual vaccination following discussion with their doctors taking into account their personal and HPV disease histories“, says Professor Xavier Bosch from the Catalan Institute of Oncology in Barcelona, Spain.

All women should continue regular screening for early detection of cervical cancer whether they have been vaccinated or not. Gardasil® is a preventive vaccine and can therefore not treat preexisting infections or disease. The vaccine cannot protect against all HPV types.

Gardasil® is the only HPV vaccine to have clinical efficacy and safety for women up to 45 years added to its product information. Gardasil® is a four-type (6,11,16,18) HPV vaccine. In addition to unsurpassed and sustained cervical cancer protection, Gardasil® can protect from cervical, vulvar and vaginal pre-cancer, and from genital warts caused by HPV types 6, 11, 16 and 18. These four types together cause the vast majority of HPV-related genital diseases.1,3,4,5

©2012 An Inconvenient Woman. All Rights Reserved.

In twin votes likely to add considerable force to U.S. marketing efforts for HPV vaccines, an FDA expert panel has voted to back GlaxoSmithKline’s long delayed application to market its HPV vaccine Cervarix to women and soon after supported Merck’s application to extend the use of Gardasil to males. Glaxo shares gain 0.5 pct, Merck shares gain 1.9 pct.

Glaxo had originally tried and failed to gain FDA approval for Cervarix back in 2007 but was thwarted by the agency’s desire to see more information on potential side effects, particularly a heightened risk of miscarriage. Since that time the pharma giant has gained approvals in more than 100 countries, while biding its time with the FDA. And while the panel concluded that the link between Cervarix and miscarriages is tenuous, the experts suggested a warning to prevent pregnant women from getting the vaccine. The panel vote makes it all but certain that Glaxo will gain final marketing approval from the FDA, opening the door to the world’s biggest drug market and finally offering Merck some competition for Gardasil. Glaxo’s shares were buoyed by the news.

Food and Drug Administration advisers, in an 11-1 vote, said Cervarix appeared safe despite miscarriages reported around the time of vaccination and a small number of autoimmune problems such as rheumatoid arthritis and lupus. Panelists urged monitoring for those issues after approval to see if there was any link to the vaccine.Merck, meanwhile, is seeking an FDA approval to use its HPV vaccine to guard against genital warts in boys and men. The panel gave Merck its support, but there was widespread agreement that the use of an HPV vaccine for males 9 to 26 offered little protection against cancer, as HPV-related penile and anal cancer cases are extremely rare. The FDA has indicated that any final approval on Gardasil’s use in males will require post-marketing safety studies.

Check out full story in  the Los Angeles Times
Read  Reuters Report

©2012 An Inconvenient Woman. All Rights Reserved.

As an expert FDA panel prepared to meet this week to review new applications to market Cervarix to prevent cervical cancer in women and expand the use of Gardasil to prevent genital warts in males, both companies got key support from FDA staffers.

On Friday, the FDA said that GlaxoSmithKline’s Cervarix is effective in preventing the two most common types of cervical cancers 93 percent of the time. And the staff report discounted any potential links between the vaccine and muscular and neurological problems, which has delayed an approval since 2007. The FDA also agreed that Gardasil was effective in preventing male genital warts.

The review of these new applications is only likely to heat up the HPV Vaccine controversy

Both vaccines have been harshly criticized by social conservatives in the U.S. And some medical experts have joined in as well, arguing that screening can be an equally effective method in stopping cancer. Nevertheless, more than 100 countries have approved the vaccines and many strongly support their use, noting high rates of efficacy.

Review  AP online article: FDA says Glaxo vaccine blocks cancer-causing virus

Read the Wall Street Journal Online Health Report: FDA Advances Merck’s Gardasil for Men, Glaxo’s Cervarix

©2012 An Inconvenient Woman. All Rights Reserved.

Fresh controversies are heating up over the marketing of products to prevent cervical cancer

The U.S. Food & Drug Administration is gearing up to make critical decisions about two controversial vaccines. On Sept. 9 an FDA advisory committee will consider whether Merck (MRK)’s Gardasil, given to girls to prevent cancer-causing human papilloma virus (HPV), should be approved for use in boys, who can be HPV carriers. The same panel will also advise the agency on whether it should allow a new HPV vaccine, GlaxoSmithKline (GSK)’s Cervarix, to enter the U.S. market. The FDA doesn’t have to follow its panels’ recommendations, but it usually does.

Sales of Gardasil to prevent cervical cancer hit a respectable $1.4 billion last year, but they are already starting to slump, and fresh controversies could pour more cold water on this whole class of vaccines. Ever since Gardasil was approved in 2006, health-care watchdogs have griped that Merck has been overselling the vaccine’s cancer-beating power without having a full understanding of potential long-term risks. On Aug. 19, Columbia University professors Sheila M. and David J. Rothman published an article in the Journal of the American Medical Assn. blasting the company for paying grants to medical organizations that are strong advocates for vaccination. “Telling every mom she needs to get her daughters vaccinated to protect them from cancer is creating a market out of thin air,” David Rothman says. “They’re already protected” through regular pap smears, he adds.

Such criticisms mark a stark turnabout for a product once hailed as a breakthrough. Cervical cancer is a scourge: 11,000 cases are expected to be diagnosed this year, and 4,000 women will probably die of the disease, says the National Cancer Institute. The vaccine could prevent more than 70% of such cases. But from Day One, Merck has been lambasted for tactics such as lobbying lawmakers to make vaccination mandatory. After a strong start in the first two years, Gardasil sales fell 5% in 2008 and second-quarter sales are down 18% from a year earlier.

Dr. Richard M. Haupt, who heads the Gardasil research program for Merck, defends the company’s marketing. “Our goal is to act in the best interest of public health,” he says, noting that many organizations have spent money to promote the cause. Should boys be vaccinated? Merck has given the FDA data showing Gardasil prevents 90% of HPV symptoms in men, but since related male cancers are rare, the main justification is to protect their partners from cervical cancer. (Gathering data is also dicey because even if there were a drop-off in cases after widespread male vaccination, Merck could never prove its vaccine deserved more of the credit than, say, improved screening.)

Glaxo, for its part, doesn’t plan to market Cervarix to boys because it doesn’t think the strategy would be worth the expense. The Centers for Disease Control estimates that vaccinating males would cost the health-care system at least twice as much per year of added life as it costs to vaccinate females.

As for payments to medical organizations, Glaxo, Merck, and their beneficiaries say their disclosures are adequate. Two recipients, the American College of Obstetricians & Gynecologists and the Society of Gynecologic Oncologists, say they put the money to many uses beyond endorsing a specific vaccine. Meanwhile, Merck’s Haupt says the scandals are drawing attention away from what could be a public health boon. “I vaccinated both my daughters,” says the father of four. And if Gardasil is approved for boys, he says, “I plan to vaccinate both my sons.”

Arlene Weintraub is a senior writer for BusinessWeek‘s Science & Technology department and published this article in Businessweek, online August 27th, 2009.

©2012 An Inconvenient Woman. All Rights Reserved.

Less then a month after a JAMA article critized Merck for aggressively marking Gardasil, Merck is planning a big-time advertising push on Gardasil, hoping to revive flagging sales of the human papillomavirus vaccine. As Advertising Age reports, the drugmaker i’s plotting its campaign for the big back-to-school shopping season.

Besides ramping up ad spending, Merck is participating in vaccine-day events with doctors’ offices and clinics, providing posters, direct-mail pieces, and pocket cards. “Resources were made available several months ago to support execution during the back-to-school time frame,” a Merck spokeswoman told AdAge.

During Merck’s recent earnings call, EVP Ken Frazier touted the Gardasil push, saying he expected “sequential growth” in the vaccine’s sales “as we leverage the back-to-school season.” Second-quarter sales amounted to $268 million, down 28 percent from the same period last year and 18 percent from two years ago.

But–and this is a big ‘but’–Frazier also said during that call that the 13-to-18-year-old market for Gardasil has already peaked. So despite the back-to-school campaign, Merck is looking outside that age group for any real growth in the vaccine. Frazier said the company is “firmly committed to achieving greater vaccination rates in the 19-to-26 age group.” And it’s still hoping for new indications–for boys and for women up to age 45–from the FDA.

See Full  AdAge article

©2012 An Inconvenient Woman. All Rights Reserved.

This week has shown that a large number of reports stating that Gardasil is proving unsafe. News stations around the world have reported that Gardasil the HPV vaccine has been found to cause adverse reactions. The adverse reactions range from mild, such as headaches, nausea and fainting, to the more severe such as seizures, blood clots, Guillian Barre Syndrome and even death.

Christina England, The American Chronicle

This week has shown that a large number of reports stating that Gardasil is proving unsafe. News stations around the world have reported that Gardasil the HPV vaccine has been found to cause adverse reactions. The adverse reactions range from mild, such as headaches, nausea and fainting, to the more severe such as seizures, blood clots, Guillian Barre Syndrome and even death. This information has come to light since the publication of the
JAMA papers on the 19th August 2009, showing the results of the VAERS Vaccine Adverse Event Reporting System. The Gardasil data published was collected from June 1, 2006 through December 31, 2008.

Merck has only recently changed packaging showing acknowledgement that this vaccine causes fainting and seizures in some children.

Information Pertaining to Labeling Revision for Gardasil

“On June 9, 2009, the Food and Drug Administration (FDA) approved a revised label for Gardasil, a vaccine to protect against cervical, vulvar and vaginal cancers caused by Human Papillomavirus (HPV) types 16 and 18 and genital warts caused by HPV types 6 and 11. In the new label, information pertaining to syncope (fainting) is now also included in the Warnings and Precautions section, and this section has new information noting that individuals who faint sometimes have tonic-clonic (jerking) movements and seizure-like activity. The addition of syncope to the Warnings and Precautions section emphasizes that healthcare providers and consumers should be alert that fainting may occur following vaccination with Gardasil, sometimes resulting in falling and injuries. To prevent falls and injuries all vaccine recipients should remain seated or lying down and be closely observed for 15 minutes following vaccination.”

Cynthia Janak a USA journalist has been writing and proving this vaccine is unsafe for the last few years. Her website Only the Truth gives tribute to the many girls who have lost their life after taking Gardasil shots. This site points out and lists the adverse reactions, showing pictures of beautiful young woman now no longer with us, other pages have stories of girls suffering every day from the adverse reactions to this vaccine. There is up to date news and views on Gardasil.

News stories have been hitting America for three years about the dangers of this vaccine. Stories like this one 2007 Did Gardasil Vaccine Cause a 12-yr-old Girl’s Paralysis and Girl Dies after HPV Jab – CDC Blame Birth Control Pill

Merck says however, Merck Says FDA And CDC Reaffirm Safety Profile Of Gardasil – Update

“Based on the review of available information by FDA and CDC, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks.”

Confusing that because if Merck were so convinced that their vaccine was safe why have they recently changed the labelling?

Diane Harper who worked on the Gardasil trials has reservations. Harper told CNN she has concerns about the safety of the HPV vaccine for pre-adolescents, noting that a small number of girls have died or suffered neurological damage after receiving the shot.

However, despite the controversy surrounding this vaccine, with much information proving it to be unsafe, it appears not only is still being offered to teenage girls across the USA and the world today but is a mandatory vaccine for immigrants wanting to come into the USA. In a sickening story in a letter passed to me a grandmother who has been raising her grandchild and was trying to escape to the USA from domestic violence was refused entry because she refused after researching Gardasil. to let her grandchild have it. The letter also shows 140 immigration rights, women´s rights, public health, medical, and reproductive justice organizations including an attorney have joined a coalition in NYS.The letter to the CDC was written as the author felt the vaccine activists might want to know the names of political organizations opposing the US immigration regulation that requires immigrants receive the Gardasil shot.

So why is it that USA citizens in many states have the option to choose whether they or their children have the HPV vaccine but immigrants can not? In order to become a permanent, legal resident of the U.S, immigrants now must receive a vaccine that is not required of U.S. citizens. This is like saying these people are less important or more likely to be infected. This surely is wrong.

For The complete article go to: http://www.americanchronicle.com/articles/view/115767

Christina England is a  UK journalist studying for an HND in journa and a member of ICAP International Coalition of Advocates for the People
i.c.a.p.org

©2012 An Inconvenient Woman. All Rights Reserved.

In the wake of new safety data on Merck’s human papillomavirus vaccine, both FDA and the Centers for Disease Control and Prevention have issued a statement supporting the product. “Based on the review of available information by FDA and CDC, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks,” the agencies said, calling the vaccine an “important cervical cancer prevention tool.”

Earlier this week the Journal of the American Medical Association published an analysis of safety data that found the most common serious side effect was fainting, though some more severe adverse event occurred in Gardasil patients, including more than two dozen deaths. But the FDA and CDC say there’s no evidence the deaths or other severe effects were actually caused by the shot, and the agencies emphasize that they have reviewed the same safety data repeatedly.

In response to the government support, Merck sought to reassure parents, encouraging them to “look to the CDC and FDA, and to the advice of their own physicians” to help them decide whether to have their children vaccinated. ”We hope that the many parents who may have been frightened this week by misleading reports understand that Merck people are parents, too,” Dr. Richard Haupt, who heads up the Gardasil program, said in a statement. “Our own children are vaccinated with Gardasil.”

- see the FDA/CDC statement
- read the release from Merck
- get the story in the Wall Street Journal

©2012 An Inconvenient Woman. All Rights Reserved.

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.

In an online follow up to the CBS TV interviews, CBS News investigative journalist, Sharyl Attkisson, reports 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.

Read Judicial Watch reports on Gardasil
Dr. LaPook’s Story on HPV
Attkisson’s Exclusive Report on Gardasil

This raises questions about the CDC’s recommendation that the series of shots be given to girls as young as 11-years old. “If we vaccinate 11 year olds and the protection doesn’t last… we’ve put them at harm from side effects, small but real, for no benefit,” says Dr. Harper. “The benefit to public health is nothing, there is no reduction in cervical cancers, they are just postponed, unless the protection lasts for at least 15 years, and over 70% of all sexually active females of all ages are vaccinated.” She also says that enough serious side effects have been reported after Gardasil use that the vaccine could prove riskier than the cervical cancer it purports to prevent. Cervical cancer is usually entirely curable when detected early through normal Pap screenings.

Dr. Scott Ratner and his wife, who’s also a physician, expressed similar concerns as Dr. Harper in an interview with CBS News last year. One of their teenage daughters became severely ill after her first dose of Gardasil. Dr. Ratner says she’d have been better off getting cervical cancer than the vaccination. “My daughter went from a varsity lacrosse player at Choate to a chronically ill, steroid-dependent patient with autoimmune myofasciitis. I’ve had to ask myself why I let my eldest of three daughters get an unproven vaccine against a few strains of a nonlethal virus that can be dealt with in more effective ways.”

Merck and the Centers for Disease Control and Prevention maintain Gardasil is safe and effective, and that adequate warnings are provided, cautioning about soreness at the injection site and risk of fainting after vaccination. A new study in the Journal of the American Medical Association found while the overall risk of side effects appears to be comparable to other vaccines, Gardasil has a higher incidence of blood clots reported. Merck says it continues to have confidence in Gardasil’s safety profile. Merck also says it’s looking into cases of ALS, commonly known as Lou Gehrig’s Disease, reported after vaccination. ALS is a progressive neurodegenerative disease that attacks motor neurons in the brain and spinal cord. Merck and the CDC say there is currently no evidence that Gardasil caused ALS in the cases reported. Merck is also monitoring the number of deaths reported after Gardasil: at least 32. Merck and CDC says it’s unclear whether the deaths were related to the vaccine, and that just because patients died after the shots doesn’t mean the shots were necessarily to blame.

According to Dr. Harper, assessing the true adverse event risk of Gardasil, and comparing it to the risk of cervical cancer can be tricky and complex. “The number of women who die from cervical cancer in the US every year is small but real. It is small because of the success of the Pap screening program.”

“The risks of serious adverse events including death reported after Gardasil use in (the JAMA article by CDC’s  Dr. Barbara Slade) were 3.4/100,000 doses distributed. The rate of serious adverse events on par with the death rate of cervical cancer. Gardasil has been associated with at least as many serious adverse events as there are deaths from cervical cancer developing each year. Indeed, the risks of vaccination are underreported in Slade’s article, as they are based on a denominator of doses distributed from Merck’s warehouse. Up to a third of those doses may be in refrigerators waiting to be dispensed as the autumn onslaught of vaccine messages is sent home to parents the first day of school. Should the denominator in Dr. Slade’s work be adjusted to account for this, and then divided by three for the number of women who would receive all three doses, the incidence rate of serious adverse events increases up to five fold. How does a parent value that information,” said Harper.

Dr. Harper agrees with Merck and the CDC that Gardasil is safe for most girls and women. But she says the side effects reported so far call for more complete disclosure to patients. She says they should be told that protection from the vaccination might not last long enough to provide a cancer protection benefit, and that its risks – “small but real” – could occur more often than the cervical cancer itself would.

“Parents and women must know that deaths occurred. Not all deaths that have been reported were represented in Dr. Slade’s work, one-third of the death reports were unavailable to the CDC, leaving the parents of the deceased teenagers in despair that the CDC is ignoring the very rare but real occurrences that need not have happened if parents were given information stating that there are real, but small risks of death surrounding the administration of Gardasil.”

She also worries that Merck’s aggressive marketing of the vaccine may have given women a false sense of security. “The future expectations women hold because they have received free doses of Gardasil purchased by philanthropic foundations, by public health agencies or covered by insurance is the true threat to cervical cancer in the future. Should women stop Pap screening after vaccination, the cervical cancer rate will actually increase per year. Should women believe this is preventive for all cancers – something never stated, but often inferred by many in the population– a reduction in all health care will compound our current health crisis. Should Gardasil not be effective for more than 15 years, the most costly public health experiment in cancer control will have failed miserably.”

CDC continues to recommend Gardasil for girls and young women. The agency says the vaccine’s benefits outweigh its risks and that it is an important tool in fighting a serious cancer.

Dr. Harper says the risk-benefit analysis for Gardasil in other countries may shape up differently than what she believes is true in the US. “Of course, in developing countries where there is no safety Pap screening for women repeatedly over their lifetimes, the risks of serious adverse events may be acceptable as the incidence rate of cervical cancer is five to 12 times higher than in the US, dwarfing the risk of death reported after Gardasil.”

©2012 An Inconvenient Woman. All Rights Reserved.

The latest issue of JAMA delivered a mixed blessing to Merck’s Gardasil. In a headliner study published by the Journal of the American Medical Association, the side effects of the human papillomavirus shot were deemed reasonable. Serious adverse events cropped in up those who got the vaccine–including some 32 deaths and two cases of Lou Gehrig’s disease–but there’s no evidence the shot actually caused them. The most common complications were fainting and clot risk.

Overall, there were 54 adverse event reports for every 100,000 doses, and some 6 percent of those were serious. “We feel confident recommending people get the vaccine; the benefits still outweigh the risks,” Dr. Barbara A. Slade, lead author and a medical officer with the Centers for Disease Control and Prevention, told the New York Times. The company sent out a release touting the news: “We are pleased that the study published by JAMA today further reinforces the safety profile of Gardasil,” Merck’s Richard Haupt said in a statement.

That’s the good stuff. The not-so-good: JAMA asks in an editorial whether any level of risk is appropriate in the case of HPV vaccination. “I wouldn’t accept much risk of side effects at all in an 11-year-old girl, because if she gets screened when she’s older, she’ll never get cervical cancer,” the editorial’s author, Dr. Charlotte Haug, told the Times.

And another JAMA study dropped a bombshell: Merck gave money to three medical societies to fund their promotion of Gardasil.

Researchers from Columbia University said the American College Health Association, the American Society for Colposcopy and Cervical Pathology and the Society of Gynecologic Oncologists used Merck funding on educational materials and lectures that offered lopsided information about the vaccine’s risks and benefits. “I think what happened here was that marketing and medical education got blurred,” co-author Sheila Rothman told the Washington Post.

“This shows how [Merck was] able to influence physicians,” Diane Harper of the University of Missouri, who helped test the vaccine, told the paper.

Merck, however, says that the $750,000 it gave to those three groups was intended to help them develop “independent” information for their membership. “[O]ur activities with these societies were done in an appropriate and independent manner,” Haupt said. The groups themselves say the funding didn’t affect the content of their materials or programs.

Read the Merck release

- check out the NYT story

- See Washington Post Article:

- read the news from FirstWord

-  find the AP story

©2012 An Inconvenient Woman. All Rights Reserved.