February 11th 2013
By: Heidi Stevenson
Using Merck's Gardasil vaccine as a case in point, an investigation documents Big Pharma's near-total control of governmental health agency decisions and the utter lack of concern by the decision makers. However, some scientists are speaking out, and here's what they have to say.
Corruption, by Mark Holloway, Image modified by changing word at center
by Heidi Stevenson
Researchers are speaking out about the corruption in science with regard to vaccines. Certainly, they're in the minority, but their expertise and solid evidence for their claims are resulting in both their studies and their concerns being published in medical journals.
The arena of vaccination, which has been adversely affecting so many children, is now a centerpoint for documenting how Big Pharma has taken over so much of science, resulting in outright fraud that's used to promote their products. Scientists Lucija Tomljenovic, Christopher A. Shaw, Judy Wilyman, Eva Vanamee, and Toni Bark use the example of Merck's Gardasil, a human papilloma virus (HPV) vaccine, to demonstrate the point that HPV vaccine activism is not based on science, but instead on misrepresentations of science.
In a letter signed by all five of these scientists, they point out several flaws in the claims that Merck's Gardasil and Pfizer's Cervarix make to sell their vaccines:
1. HPV vaccines have never been shown to prevent cervical cancer.
2. The end-points used in the studies are based on infections and lesions that usually heal without help, so how can they demonstrate efficacy in preventing cancer several years later?
3. The trials are biased to produce false negatives and therefore cannot accurately estimate the risk of developing cancer.
4. Passive methods of recording adverse effects cannot accurately reflect how prevalent they are.
5. Accurate estimates of the actual frequency of HPV vaccine adverse effects cannot be made when such effects are automatically dismissed as unrelated to the vaccine.
6. Women are not informed that, in some instances, the HPV vaccines may increase the rate at which existing abnormalities develop, thus causing the cancer from which they're supposedly being protected.
7. When information about HPV vaccine risks and limitations are not provided, women cannot possibly make informed decisions about whether to have the vaccine.
8. Health regulators are making decisions based on information provided by the same corporations that hope to profit from them. How can they possibly make rational decisions on such limited and biased information?
Investigation into Merck's Murky Dealings with Government
"Pharmaceutical Companies' Role in State Vaccination Policymaking" is an investigation into the lobbying efforts by Merck to promote the HPV vaccine, Gardasil. It states:
Merck engaged in direct lobbying to varying degrees in all of the states we studied. Merck proactively contacted legislators to discuss strategies to maximize uptake of Gardasil, either directly through company employees or by using local political consultants, prominent physicians, or public relations firms.
Many respondents reported that company representatives proposed specific legislation, often drafting the bills and searching for a sponsor. In most states, their efforts focused on a school-entry mandate. Respondents pointed out that Merck's activities were not unusual, although the public seemed to have been unaware that private companies played such a role in the legislative process. One commented, "Just about every vaccine mandate that we have lately has been the result, at least partially, of the drug industry's efforts." [Emphasis mine.]
They asked respondents, who included legislators, health officials, medical professional organizations, advocacy organizations, journalists, health insurers, and clinical researchers, what role pharmaceutical manufacturers should play. The respondents believed that pharmaceutical manufacturers should provide scientific information about the products they push and that it was appropriate for Merck reps to sit on task forces and committee meetings. Worse, though, not one person felt that there was any problem in Merck's drafting legislation!
In my reading of the paper, it appeared that the respondents tended to hide behind the fact that Merck donated some vaccine, though there were a few who found Merck's involvement to be inappropriate.
Women in Government (WIG) received funding from Merck, which some respondents felt was just fine, though opinions did vary on that point. It should come as no surprise that WIG heavily promoted implementation of the Gardasil vaccine.
The investigation documented the extremely disturbing influence that pharmaceutical corporations have in governmental health decisions that affect us all.
Response to Investigation into Merck's Influence in Government
"Who Profits from Uncritical Acceptance of Biased Estimates of Vaccine Efficacy and Safety?" is a definitive statement regarding Merck's influence in vaccine policy. Tomljenovic and Shaw state:
... [C]areful scrutiny of Gardasil clinical trials shows that their design, as well as data reporting and interpretation, were largely inadequate.
They go on to delineate that optimism about Gardasil's clinical benefits rests "on an extremely weak base built on a number of untested assumptions and significant misinterpretation of factual evidence." They cite these examples:
- The claim that Gardasil will result in a 70% reduction in cervical cancer is made in spite of there being no clinical data to support it.
- The claim that life-long protection is provided by three vaccine doses has no basis in fact, as studies lasted, at most, five years.
- The claim that Gardasil's adverse effects are minor are supported only by "highly flawed safety trial design".
- They also point out "evidence of biased and selective reporting of results from clinical trials".
Their conclusion is:
Keeping in mind that "the primary interest of a pharmaceutical company is developing and selling pharmaceutical product," one must ask whether rational vaccine policy decisions should be based on conclusions derived from an uncritical acceptance of flawed vaccine safety and efficacy estimates provided by the vaccine manufacturer. Failure to adhere to principles of evidence-based medicine with respect to Gardasil promotion and vaccination policymaking inevitably raises the question of whether we have learned anything from the Vioxx debacle.
Indeed! It most assuredly does look like nothing has been learned from past disastrous destruction of lives by Big Pharma. Just how many times must we go through such agony? The toll Gardasil has been taking is being swept under the table, but the evidence is growing, as Tomljenovic and Shaw have been documenting in their research.
How many more must suffer before we step back from the pharmaceutical juggernaut and refuse to let them manipulate and control our healthcare system?
These articles contain more information on Tomljenovic and Shaw's research:
HPV vaccines and cancer prevention, science versus activism, Infectious Agents and Cancer, Lucija Tomljenovic, Judy Wilyman, Eva Vanamee, Toni Bark, Christopher A. Shaw; doi:10.1186/1750-9378-8-6
Pharmaceutical Companies' Role in State Vaccination Policymaking, American Journal of Public Health (on Medscape), Michelle M. Mello, JD, PhD, Sara Abiola, JD, PhD, James Colgrove, PhD
Who Profits from Uncritical Acceptance of Biased Estimates of Vaccine Efficacy and Safety?, American Journal of Public Health, Lucija Tomljenovic and Christopher A. Shaw; doi:10.2105/AJPH.2012.300837