OCTOBER 1996 · VOLUME 17 · NUMBER 10
T H E I R M A S T E R S ' V O I C E
OCTOBER 1996 · VOLUME 17 · NUMBER 10
T H E I R M A S T E R S ' V O I C E
FEW TARGETS have ranked higher on the corporate agenda this year than the Food
and Drug Administration (FDA) and its commissioner, David Kessler. Acting
through their allies in Congress, the big companies behind the campaign --
especially medical device, biotechnology and tobacco manufacturers -- are
pushing legislation that would dilute the FDA's authority to review the safety
of new products and strip the agency of much of its enforcement power.
Providing the intellectual scaffolding for the corporate campaign are a number of Washington think tanks. They charge that FDA dawdling in approving new drugs has resulted in the untimely demise of tens of thousands of U.S. citizens and that the private sector could provide review faster and more efficiently than government bureaucrats.
These think tanks claim that they speak for the average citizen, chafing under the yoke of "big government" incompetence. Yet a new report from Public Citizen found that seven think tanks at the forefront of the FDA attack -- the American Enterprise Institute, the Cato Institute, the Competitive Enterprise Institute, the Heritage Foundation, the Hudson Institute, the Progress and Freedom Foundation and the Washington Legal Foundation -- took in at least $3.5 million from the very corporations which are most interested in downsizing the agency.
Another group targeting the FDA is Citizens for a Sound Economy (CSE), a think tank which also runs a "grassroots" lobby shop. Major corporations and right-wing foundations provide the vast majority of CSE's budget, which has climbed from $4 million in 1991 to $17 million last year. The group's growing popularity with Corporate America stems from its leading role in defeating health care reform, in promoting "tort reform" and in fighting off the Clinton administration's $72 billion energy tax in 1993.
CSE has spent at least $2 million on its anti-FDA effort, which has included a major newspaper and radio advertising campaign and the publication of dozens of reports charging the FDA with incompetence and misconduct. A number of CSE's funders have a keen interest in the FDA campaign, including Dow Chemical, the Pharmaceutical Research and Manufacturers of America and Philip Morris.
CSE's campaign against the FDA has not been without its humorous elements. Last year, CSE Chair C. Boyden Gray -- former counsel to President George Bush and now a lobbyist whose clients include Amgen, Inc., a pharmaceutical and biotech company -- told members of a House subcommittee of one particularly egregious example of FDA dallying, the case of the miracle drug nitrazepam. The drug "was approved five years later in the United States than it was in Britain," Gray thundered. "In that five year period ... more than 3,700 Americans could have been saved."
The force of Gray's presentation was greatly diminished when Representative Richard Durbin, D-Illinois, informed CSE's chair that the "life-saving" drug nitrazepam is used to treat insomnia, an unpleasant though not normally fatal ailment.
Indeed, charges leveled against the FDA by CSE and other think tanks are largely bogus. The FDA has already dramatically reduced approval times for new-drug applications, from an average of 33 months in 1987 to 16.5 months last year. For drugs that were deemed to constitute major therapeutic advances, the review time was just six months. And, most tellingly, during recent years, the FDA has kept off the U.S. market 47 drugs which had been approved for sale in England, France and Germany, and which were all later withdrawn due to safety problems.
Though CSE claims that the FDA is too nit-picky in its oversight role, many dangerous drugs still find their way to pharmacy shelves. According to Thomas Moore, a senior fellow at George Washington University's Center for Health Policy Research, prescription drugs annually injure about 5 million U.S. citizens seriously enough to require medical treatment.
But the campaign against the FDA has nothing to do with protecting the public and everything to do with helping corporations speed their drugs to market with only minimal scrutiny from government health officials. This point was starkly illustrated at a conference CSE held in mid-May at the J.W. Marriott Hotel in downtown Washington, D.C. under the chipper title, "The American Economy: Opportunities for Positive Change."
Among the multitude of corporate guests at the conference was Terry Adkins of Pittsburgh-based Biocontrol Technology Inc. During a brief break in the affair, he huddled with CSE's government relations assistant, Jenny Rugland, and complained about an FDA panel's decision earlier this year to keep his company's Diasensor 1000 -- which allows diabetics to use infrared light to measure blood sugar levels instead of drawing blood -- off the market until further tests are conducted. Biocontrol has invested $66 million in developing the Diasensor and the company's stock tumbled by 41 percent on the day that the FDA rejected its use.
After a lengthy discussion, during which Rugland talked about FDA reform bills CSE is trying to get through Congress, she offered to introduce Adkins to James Prendergrast, CSE's new "Mobilization Director." "That's one of the reasons I came down," said a grateful Adkins, who was promptly marched off to meet with CSE's coordinator of "grassroots" lobbying.
But Biocontrol is hardly a victim of FDA bungling. During testing the Diasensor measured blood sugar accurately in only 8 of 23 cases. Even the Juvenile Diabetes Foundation has opposed approval of the device, because erroneous information about a patient's blood sugar level can be fatal.
-- Ken Silverstein