JayaJan Pharmaceutical Research in India was one of the companies with which Merck had a contract to test Gardasil. Like most of the industry, Merck increasingly outsources its clinical trials to Contract Research Organizations (CROs) in areas of the world where trial subjects are plentiful, operating costs are low, and regulations lax. These CROs are a booming $15 billion industry whose revenues are rising at 15 percent a year. Critics point out that CROs can come with built-in problems. Conflicts of interest can arise when CROs are paid royalties only after a drug is approved rather than being paid a set fee that is independent of how safe or effective the drug turns out to be.
By promoting vaccination as a public health imperative mandated by government, rather than as a private choice, Merck has opened the door to the inherently uncomfortable discussion of whether mandatory vaccination is cost effective. Since Merck claims Gardasil protects against the two strains of HPV that cause 70 percent of cancers, women will still need but may be less likely to get Pap smear tests to catch the signs of cervical cancers caused by the other 30 percent of dangerous strains.
The study was conducted in Australia, in 2007 and reported in The British Medical Journal in Dec 2008. Sharon Choo of the Royal Children’s Hospital in Melbourne reported that during 2007 more than 380,000 doses of the vaccine had been administered in schools in Victoria and South Australia under the Australian immunization program. Choo and colleagues noted some components of Merck’s treatment — such as aluminum salts and yeast — have been associated with allergic reactions. In the British Medical Journal article, published in late 2008, she and her colleges are quoted as saying, “Our clinical recommendation is that females with suspected hypersensitivity to the quadrivalent vaccine should be evaluated before receiving more doses, and any challenges with the same vaccine should be carried out in a supervised setting.”
The U.S. Food and Drug Administration on Wednesday strengthened warnings on Merck & Co.’s (MRK) Gardasil vaccine about fainting after receiving reports of “traumatic injuries” among some vaccine recipients. In a posting aimed at health-care professionals posted to the agency’s Web site, the FDA said all vaccine recipients should remain seated or lying down and be closely observed for 15 minutes following vaccination “to prevent falls and injuries.”
International Coalition of Advocates for the People’s first educational advocacy effort has been a success. Seven women who became international advocates wrote a paper about HPV vaccines to educate all necessary parties in Europe. This paper has been distributed throughout Europe and to select individuals in the United States. Presently, thirteen German scientists from the Robert Koch Institute are questioning the effectiveness of these vaccines. They are also asking for evidence now from the Standing Committee based on the scientists’ views.
Merck could increase the size of the dividend payment it makes to shareholders every quarter following its $41.1 billion purchase of rival Schering-Plough, although the company will not commit to an increase now.
Chief Financial Officer Peter Kellogg told analysts and investors Thursday that Merck “will be generating a lot of cash” and that the company does see the need to “ultimately make sure shareholders benefit from that.” He also said, “It’s too early to declare how we will do that.”
“What concerns us is that the two manufacturers of the vaccine aren’t always using facts. They claim that a lot of high-risk strains of cancer-causing virus are protected against but equally there are others that are not. If protection is not more than 20 per cent then that is an awful lot of money to be spending, particularly as the vaccines have quite serious side-effects.” — Professor Martina Doren, of the Charitie Hospital in Berlin:
According to the Canadian Women’s Health Network, most women who don’t smoke, eat well and have a healthy immune system will clear the virus without any treatment. And the Public Health Agency of Canada has said that more than 80 per cent of HPV infections acquired at an early age were gone within a year and a half. Even better, after a woman has fought off a strain, she has almost no chance of contracting it again.
Perhaps the most impressive site to date is Gardasil’s “Take a step against cervical cancer” profile on Facebook—with more than 100,000 fans. (For comparison, American Idol’s Facebook page has about 430,000 fans.) But the big difference between the two is that “Take a step” is a one-way communicator: no comments allowed.
Richard B.S. Roden, a researcher at Johns Hopkins who was trained at the National Cancer Institute, has spent a decade developing the new HPV-vaccine. He said it will protect against a wider range of HPV types than Gardasil and can be produced for perhaps less than $1 a dose.
BlogoSquare