The benefits of the pharmaceutical industry's influence on senior Bush appointed officials within the FDA cannot be understated. These officials have the power to: (1) control billions of dollars in drug profits; (2) effect drug company stock value; (3) influence litigation; and (4) drive a company out of business.
For the past three years, Senator Grassley has pressured the agency to sever its alliance with drug companies and to act with more independence and transparency. He has also sponsored legislation to mandate a clinical trials registry and a stronger post-market surveillance process within the FDA.
In a September 20, 2006, letter to FDA acting commissioner, Dr von Eschenbach, Senator Grassley called on the FDA to address "persistent" problems at the agency, especially the "too-cozy" relationship with the industry and the inclination of agency leaders to suppress scientific dissent and drug-safety recommendations.
"I have frequently criticized the FDA for its relationship with the industry, which I believe is far too cozy," he wrote. "The FDA needs to distance itself from the industry and return to its role as regulator, not a facilitator," Senator Grassley told the acting Commissioner.
He said the most powerful message coming from increasing numbers of current and former FDA personnel is that the FDA has "sold out" to the industries it is charged to regulate.
"FDA's handling of the antibiotic Ketek," Senator Grassley said, "is another example where the FDA appears to have accommodated a drug company despite the fact that the company submitted fraudulent data from a safety study to the FDA and repeatedly provided incomplete safety information."
"What baffles me even more," he continued, "is the fact that the FDA continued to cite Study 3014 in publicly released safety information for Ketek even after its Division of Scientific Investigations concluded that Study 3014 involved "multiple instances of fraud" and that "the integrity of data from all sites involved in [the] study...cannot be assured with any degree of confidence."
Your recent meeting with FDA staff involved in the review of Ketek is a disturbing example that FDA's internal dispute resolution processes are not working, he told the acting commissioner. "Instead of reassuring FDA employees that they can raise concerns without being subjected to retaliation or intimidation," he wrote, "the meeting itself appears to be an act of intimidation."
It is beyond dispute that FDA employees are being intimidated and muzzled. A survey released by the Union of Concerned Scientists (UCS) and the Public Employees for Environmental Responsibility (PEER) on July 20, 2006, found that approximately one-fifth of the nearly 1,000 FDA scientists surveyed said that they had been asked, for nonscientific reasons, to inappropriately exclude or alter technical information or their conclusions.
One-fifth of those responding said that they have been explicitly asked by FDA decision-makers to provide incomplete, inaccurate or misleading information to the public, industry, the media and government officials, and over one-third said they could not openly express any concerns about public health within the FDA without fear of retaliation.
Experts agree that all new drugs come with possible adverse reactions, and that the list of side effects on the label of a new drug is never complete because there are always cases where certain people may have an unpredicted adverse reaction to a new drug.
However, unfortunately nowadays, once a new drug is approved, mass-marketing campaigns result in millions of people being exposed to the drug long before the serious side effects and problems with long-term use are known.
More information for injured parties can be found at Lawyers and Settlements.com
http://www.lawyersandsettlements.com/
Evelyn Pringle
evelyn.pringle@sbcglobal.net
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