October 26

"Profits" / "Prophets"_NYT Editorial: Industry Distortion of the F.D.A.

“Profits” / “Prophets”_NYT Editorial: Industry Distortion of the F.D.A.

Wed, 8 Dec 2004

A White House transcript of President Bush’s speech at the Christmas tree lighting on Thursday:
“We think of the patient hope of men and women across the centuries who listened to the words of the profits and lived in joyful expectation.”

Nineteen minutes later, The Washington Post reports, a corrected transcript changed “profits” to “prophets.”

But an announcement by the Office of Government Ethics indicates that profits, not prophets were on the President’s mind and on the minds of this administration: the Office of Government Ethics “declared that it was relaxing prohibitions on lobbying by former Cabinet secretaries and other top officials.” Not a minute to be lost from their “joyful expectations” of profits.

True to its tradition, an editorial in today’s New York Times – Industry’s Interference at the FDA–straddles the fence. No doubt, the Times supported the 1992 law that, it now acknowledges, “has grievously distorted the agency’s drug safety programs in unforeseen ways.”

Hey, the founding fathers understood the importance of checks and balances and had the guts and foresight to fashion this democratic union with built-in checks and balances – so as to ensure that the public interest, rather than the private interest, is at the forefront of public policy.

Predictably – not as the Times suggests, a surprise–the intrusion of the chemical /pharmaceutical industry into government oversight agencies has undermined public health, safety, and morality. However, the Times editors are most likely conflicted by the advertising income from the pharmaceutical industry, thus they consistently fail to take a moral stand.

FDA’s impotence vis a vis industry has resulted in hundreds of thousands of lives lost due to the marketing of lethal drugs. Industry’s influence on the Environmental Protection Agency has resulted in birth defects and increased cancer and neurological diseases. Industry’s influence on the FDA and EPA has resulted in a culture of concealment of vital evidence; the erosion of ethical standards in human research; and along the way, industry’s influence has undermined the integrity of the scientific literature.

The EPA has turned its back on the Nuremberg Code standards for permissible (i.e., ethical) human research. By funding and promoting human pesticide experiments, the EPA joins an infamous gallery of international rogues.

What moral standards guided EPA’s proposed CHEERS experiment in which parents would be paid $970 to permit their babies to be exposed to indoor pesticides so that EPA officials could afterwards – not during exposure–record the children’s bodily absorption of poison? This immoral experiment is a perfect illustration of industry’s corrosive influence on the health and welfare of the nation.

Would the $7 million in public funds not be better spent on educating the public about the hazards of pesticides and suggesting alternative methods to control pests?

Contact: Vera Hassner Sharav

Lobbying Prohibitions Eased For Former Top Officials

By Dana Milbank and Jim VandeHei
Sunday, December 5, 2004; Page A05


The timing was perfect: On Nov. 23 — exactly three weeks after the election and as a flurry of top Bush administration officials announced their departures — the Office of Government Ethics declared that it was relaxing prohibitions on lobbying by former Cabinet secretaries and other top officials.

Until now, senior officials at Cabinet departments and agencies had not been allowed to lobby former colleagues for a full year after leaving office — a rule designed to prevent an obvious conflict of interest. But, in a notice in the Federal Register, the ethics office issued a new rule invoking its power to declare that “a former senior employee who served in a ‘parent’ department or agency is not barred . . . from making communications to or appearances before any employee of any designated component of that parent.”

Specifically, the Department of Homeland Security “requested that the [Ethics] Director designate seven distinct and separate components in DHS,” including the Secret Service, the Coast Guard, the Transportation Security Administration, and the Emergency Preparedness and Response functions. The Justice and Treasury departments made similar requests.

These changes were so urgent that the ethics office found that “good cause exists for waiving the general requirements for notice of proposed rulemaking, opportunity for public comment and . . . a 30-day delayed effective date.”

Larry Noble, executive director of the Center for Responsive Politics watchdog group, was not amused.

“It’s a problem,” he said, noting that the administration also expanded the “banding,” or ranges, of asset values that must be reported, making it more difficult for the public to know how wealthy government officials are. “We’re seeing a general loosening of ethics rules,” he said.

Words Fail Us

“We think of the patient hope of men and women across the centuries who listened to the words of the profits and lived in joyful expectation.”

— A White House transcript of President Bush’s speech at the Christmas tree lighting on Thursday. Nineteen minutes later, a corrected transcript changed “profits” to “prophets.”

C 2004 The Washington Post Company


Editorial: Industry Distortion of the F.D.A.

December 8, 2004

Twelve years ago, the White House and Congress made an agreement with the pharmaceutical industry that seemed eminently reasonable at the time. The industry would supply substantial sums – reaching $200 million a year at latest count – to help the Food and Drug Administration hire more reviewers to speed the approval process for new drugs that might otherwise be held up solely by administrative logjams. The quid pro quo was that the government had to meet tight deadlines for reviewing drugs and had to keep steady its own financing for new-drug reviews, adjusted for inflation.

That seemed a reasonable way to ensure that the government did not cut back on its own funds and use the industry money to pay for reviewers already on the staff. But as an article by Gardiner Harris in The Times on Monday made clear, this 1992 deal – negotiated under the first President George Bush and updated under President Bill Clinton and again under the current president – has grievously distorted the agency’s drug safety programs in unforeseen ways.

The blame lies with successive administrations and Congresses that failed to keep sufficient funds flowing to the F.D.A. for pharmaceutical programs. As a result, the agency has had to cannibalize programs to monitor the safety of drugs after they are on the market to keep up its reviews of new drugs before they are allowed on the market. The shift in emphasis is striking. In 1993, the agency’s Center for Drug Evaluation and Research spent 53 percent of its budget on new-drug reviews, with most of the rest used for programs to ensure that drugs already on the market were safe. By last year, 79 percent of the agency’s budget went for new-drug reviews.

Almost everything else has been starved. Half of the scientists in the drug center’s labs are gone, reducing the agency’s ability to conduct independent testing of suspect drugs. Collaborations with respected academic groups that assess drug side effects have ended. Both were savaged so money could be diverted to maintain a computerized listing of side-effect reports. This is the agency’s main tool to detect postmarketing problems, and virtually all experts say it has serious shortcomings.

We are not optimistic that a Republican-dominated Congress and administration, beholden to drug industry campaign contributions, will leap to change a system that works to the industry’s advantage. But the last three presidents and their Congresses got the F.D.A. into this bipartisan mess, so Washington ought to fix it. One solution would be to revisit the agreement so corporate money could be used to support a wide range of postmarketing checks, not just initial drug reviews. An even better approach would be to increase federal support for the F.D.A. so safety monitoring would be adequately financed and the industry’s influence would be proportionately reduced. That should not prove frightfully expensive and would be a price worth paying.

Copyright 2004 The New York Times Company

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