Alliance For Human Research Proctection on the HPV vaccine

[Guest guest]

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)Promoting Openness, Full Disclosure, and Accountabilityhttp://www.ahrp.org and http://ahrp.blogspot.com FYINews reports about Merck's aggressive marketing campaign aimed at obtainingstate government mandates forcing 11 and 12 year old girls to be vaccinatedwith its Human Pappilomavirus (HPV) vaccine, Gardasil, is the latest exampleof irresponsible marekting targetting America's female population. Anotheris the recruitment of female students at university campuses who are askedto enroll as human subjects in an experimental Herpes vaccine trialco-sponsored by GlaxoSmithKline and the National Institute of Allergy andInfectious Diseases. . Below is a form letter sent out to all femalestudents at the Unviersity of Maryland offering $358. Since doctors agree that condoms are the safest and most effectiveprotection against sexually transmitted diseases-- Why are only femalesbeing sought for risky experimental vaccine trials? Gardasil is touted as prevention for cervical cancer which Merck says is thesecond-leading cancer among women around the world. But as The Wall Street Journal reports (below) the prevalence of cervicalcancer is actually low in the U.S. The American Cancer Society estimatesthat 11,150 women will be diagnosed with cervical cancer and 3,670 will diefrom it in the U.S. this year. That's equivalent to 0.77% of cancersdiagnosed in the U.S. and 0.65% of U.S. cancer deaths each year. Bycomparison, the society estimates that 178,480 American women will getdiagnosed with breast cancer in 2007 and 40,460 will die from it. These numbers underscore Merck's strictly commercial motivaiton: Gardasil'sprice tag is exorbitant-three shots at $360 each-is being forced on Americanchildren-not because they are at particular risk-but rather to ensure thatthe company profits hugely. So what is the justification for even considering mandatory vaccination ofchildren? Since 80% of cervical cancer occurs in underdeveloped countries, clearly,those who might benefit the most are denied access because they can't affordthe vaccine. The WSJ confirms that Merck is "desperate" for funding streamsand "vaccination across the U.S. would make Gardasil an automaticblockbuster." The campaign has been dubbed: "Help pay for Vioxx" litigation.Inexplicably, influential media sources have demonstrated a blindwillingness to accept without evidence, unsubstantiated promises about a newvaccine from a company whose ignoble record of fraudulent claims and illegalmarketing of a lethal drug caused thousands of preventable deaths. Prominent among these is The New York Times which rendered its position onthe side of commerce in an editorial (below) reflecting a faith-based beliefrather than a critical appraisal of evidence. Not only does the editorialendorse Merck's vaccine for all preteen girls, it offered "congratulationsto Texas for becoming the firs state to REQUIRE vaccinating youngschoolgirls-ages 11 and 12"-even as it acknowledges that "many parents areappalled at the notion of vaccinating such young girls against a sexuallytransmitted disease.GARDASIL has not been shown to protect against disease due to non-vaccineHPV types.The health-care provider should inform the patient, parent, orguardian that vaccination does not substitute for routine cervical cancerscreening. Women who receive GARDASIL should continue to undergo cervicalcancer screening per standard of care."http://www.merck.com/newsroom/press_releases/product/2006_0608.html Gardasil will not prevent cancer--it does not protect against ALL HPV types[e.g., 31, 33, 35] . The vaccine will merely result in a change of prevalentserotypes. "Tina Walker, the mother of an 11-year-old girl in Flower Mound, Texas, toldThe Wall Street Journal that she would prefer to wait until the vaccine hasbeen on the market for several years before subjecting her child to it. "Weare the guinea pigs here," she says.Under what moral authority do the editors of New York Times decree that TinaWalker's rights as a responsible parent should be nullified-and her daughterexposed to potential harm by a company that has a proven record ofconcealing the lethal hazards of its products?The Times editors would do well to examine how often the Times got it wrongwhen it endorsed any number of medical treatments that proved harmful. Forexample, on November 18, 1994, Times health columnist, Jane E. Brody, gavea ringing endorsement to hormone replacement therapy (New Therapy ForMenopause Reduces Risks, http://tinyurl.com/ysoogb ), reporting that itprotects women "not only against the risk of uterine cancer but heartattacks as well." In time, these claims were overturned by science-but notbefore untold number of women died as a result of bad medical advice. Furthermore, Merck does not deserve our trust in disclosing all we need toknow about its products. Merck marketed Vioxx as an effective, saferalternative to non-steroidal anti-inflammatory drugs for the treatment ofpain associated with osteoarthritis, but-as its secret documents lateruncovered during litigation revealed--Merck concealed the fact that Vioxxincreased the risk of cardiovascular disease.What guarantee do we have that Gardasil is not another Merck hoax?Contact: Vera Hassner Sharav212-595-8974veracare~~~~~~~~~~http://online.wsj.com/article/SB117082394405400647.html THE WALL STREET JOURNALMoves to Vaccinate Girls For Cervical Cancer Draw FireAs Merck Lobbies States To Require Shots, Some Fret Over Side Effects,MoralsBy JOHN CARREYROUFebruary 7, 2007; Page D1Bills being drafted in some 20 U.S. states that would make a cervical-cancervaccine mandatory for preteen girls are sparking a backlash among parentsand consumer advocates.The bills coincide with an aggressive lobbying campaign by Merck & Co., themaker of the only such vaccine on the market. Called Gardasil, thethree-shot regimen provides protection against the human papillomavirus, asexually transmitted virus that is responsible for the majority of cases ofcervical cancer.If the state bills become law, they would guarantee the Whitehouse Station,N.J., drug maker billions of dollars in annual revenue from the vaccine.POINTS OF CONTENTIONConcerns over mandating shots:. Some parents say a vaccine for HPV, the sexually transmitted disease thatcan cause cervical cancer, effectively condones premarital sex. . Long-term efficacy and risk of side effects are unclear. There have been82 reports of adverse events associated with the vaccine. . Gardasil is typically covered by insurance, but is costlier than manyother common vaccines. Proposed legislation varies from state to state, but the bills generallywould require girls to show proof that they have received the inoculation inorder to enter school. A number of immunizations -- including those formeasles, chicken pox and polio -- are mandatory for U.S. schoolchildrenbecause they block highly contagious diseases that can be spread easily in agroup setting. But HPV is different because it is transmitted sexually. At$360 for the three shots, Gardasil is also costlier than many vaccines (ameasles-mumps-rubella shot costs about $42.85 per dose, for instance),though it is generally covered by insurance.Conservative Christian groups have long voiced opposition to the vaccine,saying it would conflict with their message of abstinence because it would,in effect, condone premarital sex. However, concern has spread beyond thereligious right as momentum has grown for making inoculation mandatory. Agrowing number of parents are worried about exposing their children to theunforeseen side effects of a new vaccine to protect them from a disease thatis no longer very common in the U.S. and often doesn't develop until muchlater in life.Tina Walker, the mother of an 11-year-old girl in Flower Mound, Texas, saysshe would prefer to wait until the vaccine has been on the market forseveral years before subjecting her child to it. "We are the guinea pigshere," she says.Last week, Texas Gov. Rick Perry issued an executive order mandating thatthe vaccine be administered to all girls entering the 6th grade in the stateas of September 2008. The Texas executive order, which includes an opt-outclause for religious or other "reasons of conscience," enabled the governorto bypass what would have likely been a heated debate in the TexasLegislature.Many of the state bills contain opt-out clauses, but a few don't. The billpending in Florida would bar students ages 11 or 12 from being admitted topublic or private school in the state unless they can provide proof thatthey have been vaccinated or that their parents opted them out afterreceiving information about cervical cancer and the vaccine.Merck says cervical cancer is the second-leading cancer among women aroundthe world, but the disease's prevalence is actually low in the U.S. TheAmerican Cancer Society estimates that 11,150 women will be diagnosed withcervical cancer and 3,670 will die from it in the U.S. this year. That'sequivalent to 0.77% of cancers diagnosed in the U.S. and 0.65% of U.S.cancer deaths each year. By comparison, the society estimates that 178,480American women will get diagnosed with breast cancer in 2007 and 40,460 willdie from it.Adding to some parents' concern, 82 adverse events among both teens andadult women have been reported since Gardasil became available last June.Many involve common immune-system responses to vaccines, such as nausea,fever or rashes. But a number of patients suffered syncopes, or faintingspells.Richard Haupt, Merck's executive director of medical affairs, says thesyncopes are caused by patients' anxiety at having a needle stuck in theirarm and not due to any neuro-immune reaction to the vaccine. Mr. Haupt addsthat the number of adverse events is small compared with the hundreds ofthousands of doses of the vaccine administered so far in the U.S.However, with any newly approved drug or vaccine, side effects often don'tbecome apparent until a regimen has been on the market for a while, leadingsome patient and consumer advocates to urge states to hold off on requiringvaccination until Gardasil's safety is more clearly established.Of the more than 25,000 patients who participated in clinical trials ofGardasil, only 1,184 were preteen girls. "That's a thin base of testing uponwhich to make a vaccine mandatory," says Barbara Loe Fisher, co-founder ofthe National Vaccine Information Center, an advocacy group that lobbies forsafer vaccines.Gardasil is approved for females ages 9 to 26, and the three-dose regimen isthe same for all age groups. The vaccine protects against four strains ofHPV that cause 70% of cervical cancer cases. So it would not eliminate theneed for vaccinated women to have regular Pap smears to detect cancerouscells caused by other HPV strains. HPV is also the virus that causes genitalwarts.Merck acknowledges that it doesn't know yet whether an initial vaccinationwill offer lifetime protection or whether patients will need booster shots.So far, the company has shown only that the vaccine lasts five years.Merck started lobbying state legislatures to pass laws requiring vaccinationlast year after the Centers for Disease Control and Prevention's Committeeon Immunization Practices recommended that all girls get the vaccine whenthey turn 11 or 12. Another HPV vaccine, called Cervarix, is in developmentfrom GlaxoSmithKline PLC, but so far Gardasil is the only regimen on themarket.As part of its lobbying campaign, Merck has been funding Women inGovernment, a Washington, D.C.-based advocacy group made up of female statelawmakers. An executive from Merck's vaccine division, Deborah Alfano, saton Women in Government's business council last year, and many of the billsacross the country have been introduced by members of the group.Merck declined to say how much money it has funneled into its lobbyingcampaign, or contributed to Women in Government. A spokeswoman for Women inGovernment, Tracy Morris, declined to say how much it had received fromMerck. In Texas, one of Merck's lobbyists is Gov. Perry's former chief ofstaff, and Merck's political action committee contributed $6,000 to thegovernor's re-election campaign."Parents should be concerned that the only company that makes this vaccineis pushing behind the scenes for mandatory laws," says Maryann Napoli,associate director for the Center for Medical Consumers, a consumer groupbased in New York.At a Merrill Lynch conference yesterday, Margaret McGlynn, the president ofMerck's vaccine division, acknowledged the company's aggressive lobbyingcampaign but said, "States decide what works for them." She added that shehad her own daughter vaccinated with Gardasil and "immunizing femalesagainst cervical cancer is absolutely the right thing to do."Mandatory vaccination across the U.S. would make Gardasil an automaticblockbuster for Merck at a time when the patents on some of its bestsellingdrugs are expiring and it's desperate to replace their revenue streams.Gardasil's sales in 2006 were $235 million.Cervical cancer is a much bigger problem in the developing world, whichaccounts for more than 80% of cases of the disease. Merck says it'scommitted to bringing the vaccine to developing countries, but for now itsavailability is limited there to a few studies and demonstration programs.Write to John Carreyrou at john.carreyrou ~~~~~~~~~Herpes Vaccine: GlaxoDear student, The National Institute of Allergy and Infectious Diseases (NIAID) of theNational Institutes of Health (NIH) has joined forces with GlaxoSmithKlineBiologicals to develop the Herpevac Trial for Women. The Herpevac Trial forWomen is investigating a promising vaccine to protect women against genitalherpes, an infection that hundreds of thousands of women acquire each year.With more than 20 trial sites across the country, the Herpevac Trial forWomen is testing the vaccine in women between the ages of 18 and 30 who havenot been infected with herpes simplex virus (HSV), which causes cold soresand genital herpes.The University of Maryland College Park is one of these centers and we areaiming to recruit 500 eligible women into the study. Participants will begiven an investigational vaccine. There is a $380 compensation forsuccessful completion of the study. We would like to use this medium to reach you and other young ladies. Wehave been having health talks and information sessions in classes and wouldlove to speak with you and answer your questions. Please check out our website <http://www.herpesvaccine.nih.gov>OrContact us at:University of Maryland Center for Vaccine Development/ Maryland CaresRoom 2165 University Health CenterCollege Park, MD 20742Phone (301) 314-7575Jane Cowan RN, BSNResearch Coordinator(301) 314-4747 (fax)mdcares <mdcaersThank you for your interest ~~~~~~~~~~~~~THE NEW YORK TIMESFebruary 6, 2007EDITORIALA Vaccine to Save Women's Lives Congratulations to Texas for becoming the first state to require vaccinatingyoung schoolgirls - ages 11 and 12 - against a sexually transmitted virusthat causes cervical cancer and genital warts. Other states would be wise tofollow the same path.There is no doubt that Merck's vaccine against the human papillomavirus,given in three shots over eight months, is highly effective. It providesnearly perfect protection against two strains that cause 70 percent of allcases of cervical cancer, and against two other strains that cause 90percent of genital warts cases. (That still leaves 30 percent of thecervical cancer cases to worry about, so women are urged to keep gettingregular Pap tests to screen for signs of the cancer.) The side effects aregenerally mild: pain or tenderness at the site of the injection. Many parents are appalled at the notion of vaccinating such young girlsagainst a sexually transmitted disease. But the medical reality is that thevaccine will generally not work after a woman has been infected, so it isbest for girls to be vaccinated well before they become sexually active. Thenation's top advisory committee of immunization experts has recommended thatthe vaccine be routinely given to girls 11 and 12 years old. The most contentious issue is whether the shots should be required or simplyrecommended to parents through a strong educational campaign. Those opposedto compulsory vaccination complain that there are already a slew of requiredvaccinations, so why heap on another, especially for a disease that isspread only through sexual contact? Critics also fear that HPV vaccinationmay lead some students to wrongly assume that they are protected against allsexually transmitted diseases, perhaps encouraging them to engage in riskybehavior. None of these objections seem strong enough to forgo the protection againsta devastating disease. The United States records some 10,000 new cases ofcervical cancer each year, and 3,700 cervical cancer deaths. Gov. Rick Perryof Texas, a conservative Republican, has taken an "opt out" approach, inwhich vaccination is required but parents can seek an exemption for reasonsof conscience or religious beliefs.That makes sense to us. All students deserve protection against HPVinfection, and the presumption should be that they will get it. Copyright 2007 The New York Times CompanyFAIR USE NOTICE: This may contain copyrighted (C ) material the use of whichhas not always been specifically authorized by the copyright owner. Suchmaterial is made available for educational purposes, to advanceunderstanding of human rights, democracy, scientific, moral, ethical, andsocial justice issues, etc. It is believed that this constitutes a 'fairuse' of any such copyrighted material as provided for in Title 17 U.S.C.section 107 of the US Copyright Law. This material is distributed withoutprofit.