Public Health? Profit? What Drives The HPV Vaccination Campaign?
In November 2006, Merck & Co. Inc. began its high pressure saturation 'One Less' campaign for its genetically engineered drug, GARDASIL, being hailed as a tool to prevent cervical cancer caused by two of over thirty human papillomaviruses that have been identified as causing cervical cancer.The American Cancer Society states at its web site:
Most people will never know if they have HPV because no significant disease develops and the immune system suppresses the virus. A small percent of people with HPV will have the virus for a longer time and will develop cell changes that may lead over many years to cervical or other anogenital cancer.
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Earlier, in April 2006 and according to a PharmaceuticalOnline.com article, Merck & Co. Inc., a self professed global research-driven pharmaceutical company, under new leadership and poised to become, among other things, ”....(the company) that investors can look to first for growth among pharmaceutical companies....”, in the process of restructuring the company, decided to begin a new focus for the company, which was revealed at its Annual Meeting of Stockholders.
This article states:
“....(T)he first strategic action is the decision to concentrate research and development efforts in nine therapeutic areas; Alzheimer's disease, atherosclerosis, cardiovascular disease, diabetes, novel vaccines, obesity, cancer, pain and sleep disorders. These areas were selected because of the opportunity Merck believes they provide, both due to the enormous unmet need that exists and because of the likelihood that the Company can make a real difference in discovering effective, safe and highly desired treatments.”
The likelihood is that any or all of the diseases and conditions named are diseases and conditions for which Merck has acquired some type of patent claim or Merck has entered into an agreement with some other drug company or entity that claims to hold title to the investigation of any possible gene or genes associated with the named conditions and diseases at the focal point of this new strategy.
How can or how does a drug or genetic research company or any entity own a human gene? It seems a related matter was settled in court with some judicial body deciding that if the scientist can demonstrate the ability to transform a substance into a form not found in nature, a patent can be given. Therefore, if through the use of science, one can extract or remove a substance from something occurring in nature, with that substance previously existing in nature only as a part of the whole of that something in nature, a patent can be obtained.
Any gene that has been identified in the human body may be or could soon be the alleged private property of some lab or drug company because of a patent issued by the United States Patent Office.
It is a fact that 20% of the genes found in the human body have been patented by the United States Patent Office, allowing private companies that claim ownership of these genes the ability to collect millions of dollars from fellow researchers seeking to use any gene patented by another researcher or company.
This, in turn, drives up the costs of health related services, like testing, allowing any entity, i.e. pharmaceutical or genetic engineering company, to seek whatever price it chooses from scientists and companies, allowing any patent holder to block the release of a possibly cheaper product if the product was created by a competitor using the patent holders' alleged property, a human gene.
At Genetic Engineering and biotechnology News, under Breaking News, Merck announces worldwide sales will be driven by the company's major products. Sales forecasts worldwide in 2007, for vaccines alone at Merck, are estimated at $2.8 to 3.2 BILLION dollars.
Despite this rosy outlook proclaimed by Merck, it is revealed, in the Merck Shareholders of 2005 report, available on line, that Merck is a party to claims brought in court against the company in the United Kingdom under that country's Consumer Protection Act of 1987, which alleges certain children suffer from a number of conditions, among those being autism, with or without inflammatory bowel disease, epilepsy, encephalitis, encephalopathy, characterized as altered brain function, with the three main causes being liver disease, kidney disease and lack of oxygen to the brain. Guillain-Barre syndrome and transverse myelitis are also conditions named that are suffered by children in the claims filed in the United Kingdom.
These lawsuits were brought on behalf of children alleged to have been injured as a result of being vaccinated with various bivalent vaccines for measles and rubella, including Merck's MMRII. The company states it will, “....vigorously defend against these lawsuits.”
In the United States, anyone seeking damages against a vaccine manufacturer for vaccine related injuries must first file a complaint in the United States Court of Federal Claims also known as Vaccine Court. Merck states it has been successful in having cases dismissed on the grounds the claims were not first submitted to the Vaccine Court.
Merck is party to individual and class action product liability lawsuits and claims in the United States, with approximately 775 plaintiffs filing suit, involving pediatric vaccines, like Hepatitis B vaccine, which contained thimerosal as a preservative. The company states it has not distributed vaccines using thimerosal since the fall of 2001.
Again, Merck vows to, “.... vigorously defend against these lawsuits....” in the States as well, stating, however, that it is possible that, “....unfavorable outcomes could have a material adverse effect on the company's financial position, liquidity and results of operations.” In other words, negative outcomes could effect the company's profits and cash flow.
Let's not forget, Merck has ongoing financial woes with another of its drugs, Vioxx, resulting in a $141.4 million dollar loss due to voluntary worldwide withdrawal, with $604 million set aside for legal defense costs to be used only for Vioxx litigation.
Reported online at Drug Pipeline News in September 2006, reporting on comments made by David Stout, president of GlaxoSmithKline's pharmaceutical operations:
Stout noted that Merck, with its “Tell Someone” advertising campaign, is now doing the heavy lifting of educating consumers about HPV and vaccines, which could make Glaxo's job easier once Cervarix is launched....
Cervarix is the HPV vaccine manufactured by GlaxoSmithKline.
Drug Pipeline News article states further:
Ironically, Glaxo will profit from GARDASIL- Merck is paying it (GlaxoSmithKline) royalties under terms of a February 2005 settlement of the companies' competing patent claims for their respective vaccines. Under the settlement and license agreement, Merck was to make an up-front payment to Glaxo and pay ongoing royalties on GARDASIL's sales.
Merck, of Whitehouse Station, N.J., disclosed last month it will have to pay royalties on GARDASIL totaling about 24% to 26% of sales, including payments to Glaxo. The royalties include payments to CSL Ltd. Of Australia. Merck didn't break out the portion of the royalties going to Glaxo.
CSL Limited, at its website, identifies that the CSL Group of companies ”.... develop(s), manufacture(s) and market(s) pharmaceutical products of biological origin....” and is based in Australia.
From a media statement at the CSL Group website, dated August 24, 2005:
CSL Limited, Australia’s leading biopharmaceutical company, today announced that it has signed a license and option agreement with Merck & Co. Inc., of Whitehouse Station, New Jersey, USA, granting certain rights and options to Merck in a number of fields for the use of CSL’s ISCOMATRIX® adjuvant in Merck’s pipeline of investigational vaccine products.
WebMD.com defines an adjuvant as a substance added to a drug product formulation that affects the action of the active ingredient in a predictable way.
The media statement at CSL Ltd. continues:
Under the terms of the agreement, CSL will receive certain payments upon achievement by Merck of development and regulatory events, and royalties on vaccine product sales. In addition, Merck will make option payments to CSL upon the exercise by Merck of licenses to certain additional uses. CSL will supply all of Merck requirements for the ISCOMATRIX® adjuvant for development and commercialization. CSL will also receive distribution rights in Australia for certain vaccines developed using this technology. Additional financial terms were not disclosed.
Richard T. Clark, identified as chief executive officer and president of Merck & Co. Inc., in an article appearing under Breaking News at the Genetic Engineering & biotechnology News web site at www.genengnews.com, is quoted as saying:
The impressive sales performance of our newer and in-line products coupled with the rapid uptake of new, first-in-class vaccines and medicines like GARDASIL and JANUVIA, speaks to the strength of our underlying business and product portfolio. These results clearly set the stage for our performance in 2007 as well as continued progress toward our long term financial targets.
Reported in the Fort Wayne Daily News on March 14, 2007, in an article by Cindy Bevington, Dr. Diane M. Harper, an independent researcher that has spent 20 years developing the vaccine for human papilloma virus, shares her thoughts regarding the HPV vaccine, saying it is not for younger girls, stating that it's effectiveness in younger girls has not been tested, saying, ".... It is still a good vaccine. But, let's be honest. Don't over-promise."
She states that administering the vaccine to girls as young as 9 years of age may not protect them at all. Regarding the HPV vaccine, Dr. Harper states:
"This vaccine should not be mandated for 11 year old girls. It's not been tested in little girls for efficacy. At 11, these girls don't get cervical cancer - they won't know for 25 years if they will get cervical cancer."
“Giving it to 11- year-olds is a great big public health experiment,” said Diane M. Harper, a scientist, physician, professor and the director of the Gynecologic Cancer Prevention Research Group at the Norris Cotton Cancer Center at Dartmouth Medical School in New Hampshire", with the article further quoting Dr. Harper as stating that it is ”..... silly to mandate vaccination of 11-to –12 year olds. There also is not enough evidence gathered on side effects to know that safety is not an issue.”
In the article, Dr. Harper's concerns are continued:
For the governors of the states in this country, Harper has another message. One has to do with the fact that vaccinating little girls now is not going to protect them later. Since it can take a decade or more to even manifest itself as dysplasia, the HPVs against which this vaccine works may infect a little girl at the age she needs the vaccine most – meaning she will have to have a booster at the right point in time or she will not be protected. And, remember, it won't work at all if she was positive for the virus when she was inoculated in the first place.
Merck knows this, Harper said. “To mandate now is simply to Merck's benefit, and only to Merck's benefit,” she said.
Again, from Genetic Engineering & Biotechnology News, it states, as of November 1, 2006, with November 2006 being the month Merck began its 'One Less' GARDASIL recruitment campaign, that GARDASIL was added to the U.S. Centers For Disease Control and Prevention's Vaccines For Children (VFC) Program, with approximately half of all childhood vaccines in the United States being purchased through the Vaccines For Children Program. 50 of the 55 Vaccines For Children projects have placed orders for GARDASIL.
Merck reports sales of GARDASIL in 2005 totaled $235 million. GARDASIL has been approved for use in 52 countries, all under “accelerated review” with applications pending in more than 50 nations.
At the American Cancer Society website, a projected figure of 3,670 deaths in the U.S. will be attributable to cervical cancer, a small fraction of the total 270,100 projected U.S. female deaths that will occur from all cancers. Cervical cancer has been on the decline in the United States for decades, according to federal data, due largely in part to the use of PAP smears and improved techniques for detection of precancerous lesions.
With members of the board of directors at Merck & Co., a self professed global research-driven pharmaceutical company, representing major multinational corporations and foundations, banks, research hospitals, medical schools and genetic research entities and given specific circumstances relating to the possible financial motivation and the desire to produce a profit, major consideration must be given when reviewing the company's rationale for accelerated promotion of its product(s).
Before accepting the often repeated, and what can be termed, 'company line' about how remarkable any product may be, a determination should be made regarding the financial motivation behind any product's release onto the market, especially medicines being hailed as the next greatest thing since the discovery of penicillin.
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