The FDA, without any research, approved of hormone-replacement drugs which exposed millions of people, about thirty-eight percent of postmenopausal women, to a drug that may cause heart disease, stroke, and cancer, and fail to prevent bone loss as promised in the advertisements. The drug company was criminally negligent and the FDA was no better.
Then there is the example of Gardasil. On May 18, 2006, Merck announced that the FDA’s Vaccines and Related Biological Products Advisory Committee collectively agreed that the data from Phase II and Phase III clinical trials proved the effectiveness and safety of Gardasil for human papillomavirus (Types 6, 11, 16, 18) for the prevention of cervical cancer and for the prevention of cervical, vulvar and vaginal pre-cancers caused by human papillomavirus (HPV) types 16 and 18 in females. Merck submitted Gardasil to the Biologics License Application (BLA) in December 2005.
On June 6, 2006, the BLA approved Gardasil. Researchers at the National Cancer Institute at the NIH, a government agency, created Gardasil. The agency now earns royalties with each and every Gardasil vaccine injection. The government mandates a product from whose sale it financially benefits. The FDA approved Gardasil on June 8 for females from nine to twenty-six years of age, after supervising the clinical tests. The agency licensed Merck’s marketing of Gardasil. On June 29, the ACIP met and formally approved Gardasil; twenty-three days after the FDA approved the vaccine. It was a unanimous vote; two of the fifteen members abstained due to their financial ties to Merck. Government agencies, in an unethical public-private partnership with Merck, shared in the huge profits; the NIH financially rewarded its in-house creators. Following the vote, vaccine enthusiasts applauded; members were glad-handing and celebrating their victory, as reported by numerous vaccine safety advocates who had attended because of their concerns about the flu vaccines and thought that the celebratory reaction was “inappropriate.” About fifty percent of those who sit on the FDA drug approval advisory panels FDA have financial connections to pharmaceutical companies.
Merck, using the scare tactics so common with the advent of all vaccines, began a television and Internet merchandising campaign for Gardasil to create its consumer base, even before the FDA approved it. Instead of marketing Gardasil among populations in geographic areas that had an excessive cervical cancer mortality rate, Merck marketed to the general population. With its deep-pocketed lobbyists, the drug company influenced state and federal lawmakers who Merck hoped would make Gardasil compulsory for schoolchildren and even preschoolers. While cancer is prevalent, cervical cancer is not among the top ten cancers in the United States. The federal government mandated Gardasil for the poor of the nation, girls up to the age of eighteen, all at the taxpayer’s expense, which amounts to over $1 billion. Hundreds of doctors promoted Gardasil for $4,500 per lecture.