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How much confidence do you have for medical procedures?

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The full article goes into much greater detail. This follows on the heels of the statement made by GlaxoSmithKline that up to 50% of the people taking any particular drug will have unexpected results do to our genetic diversity.)

SPECIAL EDITION: LA Times Exposé of the NIH-Pharmco Axis and Follow-up

Stealth Merger: Drug Companies and Government Medical Research

Some of the National Institutes of Health’s top scientists are also collecting paychecks and stock options from biomedical firms.
Increasingly, such deals are kept secret.

“The problem is far more wide-ranging than we previously understood,” (Rep.) Waxman said in an interview. “If NIH can’t set rules to protect the integrity of scientists, then Congress should. But it’s hard for me to imagine that Congress will, because Congress is so beholden to the pharmaceutical industry.”

By David Willman, for the LA Times.

http://www.latimes.com/la-na-nih7dec07,1,3506168.story

Two decades ago, the NIH was so distinct from industry that Margaret Heckler, secretary of Health and Human Services in the Reagan administration, could describe it as “an island of objective and pristine research, untainted by the influences of commercialization.”

Today, with its senior scientists collecting paychecks and stock options from biomedical companies, the NIH is no longer an island.

Increasingly, outside payments to NIH scientists are being hidden from public view. Relying in part on a 1998 legal opinion, NIH officials now allow more than 94% of the agency’s top-paid employees to keep their consulting income confidential.

As a result, the NIH is one of the most secretive agencies in the federal government when it comes to financial disclosures. A survey by The Times of 34 other federal agencies found that all had higher percentages of eligible employees filing reports on outside income. In several agencies, every top-paid official submitted public reports.

The trend toward secrecy among NIH scientists goes beyond their failure to report outside income. Many of them also routinely sign confidentiality agreements with their corporate employers, putting their outside work under tight wraps.

Dr. Ruth L. Kirschstein, who as the deputy director or the acting director of the NIH since 1993 has approved many of the top officials’ consulting arrangements, said she did not believe they had compromised the public interest. “I think NIH scientists, NIH directors and all the staff are highly ethical people with enormous integrity,” she said. And I think we do our business in the most remarkable way.”

In response to The Times’ findings, Kirschstein said, she would “think about” whether administrators should learn more about a company’s ties to the NIH before approving the consulting arrangements

The NIH traces its beginnings to the Laboratory of Hygiene, founded in 1887 within a Navy hospital on Staten Island in New York. It became the federal government’s first research institution for confronting such epidemic diseases as cholera, diphtheria, tuberculosis and smallpox.

The laboratory’s success convinced Congress of its value in seeking cures for diseases.

In 1938, the renamed National Institute of Health moved to its present, 300-acre headquarters in Bethesda, about nine miles north of the White House.

The agency’s responsibilities — and prominence — have grown steadily.

In 1948, four institutes were created to support work on cardiac disease, infectious diseases, dental disorders and experimental biology. “Institute” in the agency’s name became “Institutes.”

President Nixon turned to the NIH in 1971 to lead a war on cancer. The agency has led the government’s fight against AIDS. Two years ago, President Bush enlisted the NIH to help counter biological terrorism.

Republican and Democratic administrations have boosted spending
For the 27 research centers and institutes that compose today’s NIH. Since 1990, the annual budget has nearly quadrupled, to $27.9 billion this fiscal year.

Senior NIH scientists are among the highest-paid employees in the federal government.

In November 1995, then-NIH Director Harold E. Varmus wrote to all institute and center directors, rescinding “immediately” a policy that had barred them from accepting consulting fees and payments of stock from companies.

The changes, he wrote, would bring the NIH ethics rules more in line with new, less stringent, executive branch standards. Loosening of restrictions on employees’ outside pursuits was occurring throughout the government. And with biomedical companies ready to hire, few were better positioned to benefit than employees at the NIH.

While making it easier for scientists to cut consulting deals, the NIH has made it harder for the public to find out about them.

The Ethics in Government Act requires yearly financial-disclosure reports from senior federal employees. This year, employees paid $102,168 or more generally must disclose outside income by filing a “278” form, which is available for public review. Other employees may file a “450” form — which does not specify the amount of money received from an outside party and is kept confidential.

At the NIH, 2,259 employees make more than $102,168, according to data provided by the NIH. Those records show that 127 of the employees about 6% — are filing disclosure forms available to the public.

From 1997 through 2002, the number of NIH employees filing public reports of their outside income dropped by about 64%, according to the agency records. Most of those employees have switched to filing the confidential 450 form.

Officials at the NIH said that an advisory legal opinion from the U.S. Office of Government Ethics gave them the discretion to bypass public disclosure.

Issued in 1998, the opinion said that the threshold for public disclosure was to be set, not by a federal employee’s actual salary, but by the low end of his or her pay grade. If the minimum salary in an employee’s grade is beneath the $102,168 threshold, he or she is exempt from filing a public report.

The NIH has shifted many of its high-salaried employees into pay plans with minimums that dip below the threshold.

And here is a follow up article:

Records of Payments to NIH Staff Sought: LA Times Follow-up
Two congressmen ask health institutes’ leader to detail researchers’ links to drug companies.

[By David Willman, for the LA Times.]

http://www.latimes.com/news/nationworld/nation/la-na-nih9dec09,1,25612.story?coll=la-home-headlines

Submitted by Anonymous on Tue, 12/16/2003 - 4:45 PM

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PBS Frontline program about the FDA

It would be nice to live in an ideal world; however, while the FDA is better than no FDA, it appears the FDA in the real world can be, occasionally, an imperfect government bureaucracy/whatever.

http://www.pbs.org/wgbh/pages/frontline/shows/prescription/hazard/

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