We mostly think of the FDA as the government agency responsible for approving medications, but this agency is also responsible for the review and approval of the medical devices, such as pacemakers and breast implants, used for diagnostic or therapeutic purposes.
Review of devices. The amount of proof needed for a new device to gain the approval and endorsement of the FDA depends on the newness and complexity of the apparatus itself. For almost a year, however, a number of FDA scientists, as well as critics from outside the agency, have complained that the agency has been approving many medical devices without requiring them to undergo the rigorous review and extensive testing mandated by law.
In 2007, for example, only 41 devices underwent the most thorough approval process, while the remaining 3,000 or so gadgets to be evaluated were approved after only abbreviated reviews.
The whistleblowers at the FDA also contend that they've been forced by agency supervisors to alter their scientific reviews so that certain devices could be approved more easily.
The agency has begun an internal investigation of these charges. One of their internal documents indicates that a Congressman called an FDA supervisor to inquire about the fate of a new computer device aimed at improving the detection of breast tumors during mammography procedures. This caller was apparently trying to hurry-up the approval process.
But if such an accessory device is approved without adequate testing, the apparatus might cause cancers to be missed (false negative), or see cancers that are not really there (false positive)—and so prompt unneeded biopsies or surgical procedures.
Agency scientists have grown dissatisfied with the pace of this internal investigation and have written to Congress and to President Obama's administration pleading for an outside investigation of the FDA's procedures for approving new devices.
Financial conflicts in the conduct of clinical trials. Since 1999, FDA rules have required drug and device companies to collect information on all possible financial conflicts of all doctors who will be overseeing any clinical trial. In fact, these rules state that any serious conflicts of interest must be resolved by the agency before any clinical trial can be launched.
Now, however, the inspector general of the Department of Health and Human Services has found that the FDA has done little or nothing to investigate or police possible financial conflicts of doctors conducting clinical trials evaluating either drugs or medical devices. And, as if this revelation were not shocking enough, the FDA officials themselves informed inspectors that it was just not worth their (the officials') time to root out financial conflicts and so protect the subjects participating in trials.
I would agree that such financial conflicts are unlikely to endanger the participants in clinical trials, but I do think that the large amounts of money some doctors receive as salary support, honoraria, stock options, consulting fees, and grants are just too outsized. The average payments to the scientists who actually have reported receiving money and gifts from drug companies were substantial: about $47,000 in consultation fees or honoraria, and, for those receiving company stock, a median value of about $65,000.
Such large fees probably do not influence the results of clinical trials, but they might influence the way a researcher interprets those results. Such payments might even tempt him or her to use questionable data when deciding whether a drug was safe and effective. Such a faulty opinion might later convince the FDA to approve a harmful or useless drug.
Bottom line. Since the FDA must rely on the expertise of (mostly) medical-school faculty to carry out clinical trials of drugs and devices, the agency must obviously review the financial conflicts among these investigators. Otherwise, how can the agency ensure proper handling and interpretation of the data arising from these trials? The public is understandably wary when these investigators receive such large amounts of money from the very companies whose drugs or devices are being tested.
And yet the FDA had no permanent commissioner for more than half of President Bush's 8 years in office, and during that time it has faced a seemingly endless series of controversies regarding drug, device, and food safety. I believe President Obama must appoint a strong leader for the agency to restore confidence of consumers in the FDA and in the drugs, devices, and foods it approves.
