FDA Scientists Appeal to Obama for Changes
Imagine a world where drugs and medical procedures are released to the public without proper testing for safety or efficacy. Nine scientists from the FDA are concerned about just that and have shared these concerns by sending a letter to president-elect Obama and his transition team, stating there has been "gross mishandling" by FDA managers, putting the country at risk. They are asking for a restructuring of the agency, stating that managers have "ordered, intimidated and coerced scientists to manipulate data in violation of the law."
The scientists' concerns focus on the agency's scientific procedures in reviewing the safety and efficacy of medical devices. Not a new problem, the scientists cited a breakdown of the independent scientific review process at the FDA as far back as 1998, when Tom Daschle, Mr. Obama's choice to head the Department of Health and Human Services, wrote about the issue in his book, "Critical: What We Can Do About the Health-Care Crisis." In that book, Daschle described how mammography computer-aided detection devices were not appropriately approved, thus setting into motion a chronic breakdown of the FDA's system.
Daschle noted that these devices were not backed by clinical evidence showing they were effective in detecting breast cancer, thus causing undue biopsies for thousands and thousands of women. For the past three years, FDA scientists and physicians have recommended five times that these mammography devices not be approved without valid clinical, scientific evidence.
The group has pointed out that there is a gross lack of competence and trust, with the honest employees fearing the dishonest employees. They point out "corruption and distortion" by the current staff and are pleading to Obama to make sweeping changes, with the hopes that certain managers at the FDA will be removed.
Among the charges listed in the letter:
- Scientists and doctors have been threatened and told, on occasion, to ignore FDA regulations.
- Devices have not been properly labeled.
- Managers without appropriate experience have been given authority to make final decisions about device regulation and have done so while ignoring serious safety and effectiveness concerns.
- FDA experts have been excluded from product meetings because manufacturers felt that they were "biased."
- Manufacturers have been allowed to market their products without FDA approval.
As ADHD medications continue to be developed and approved, we can only hope that the new administration heeds the concerns of the scientists and makes the changes necessary in order for the American public to safely be treated. In fact, with SPECT scans and other devices being developed and even currently utilized in helping to diagnose ADHD and comorbid disorders, it's imperative that these devices be appropriately developed and approved before being used on children and adults.