October 26

NIH Under Fire: Longtime Favorite of Congress – Wash Post / WSJ

NIH Under Fire: Longtime Favorite of Congress – Wash Post / WSJ

Sun, 27 Jun 2004

Under fire from Congress with evidence of NIH staff engaging in secret outside contracts and consultancies, NIH Director, Dr. Elias Zerhouni, turned a corner. He acknowledged the problem at a hearing (June 22) of the House oversight subcommittee of the Energy and Commerce Committee, and issued a series of reforms to bring NIH researchers in line with government guidelines on outside activities and remuneration. His predecessor, Dr. Harold Varmus, had waived conflicts of interest guidelines, apparently believing that scientists have special entitlements and are less given to greed and temptation than other mortals.

The Congressional probe was prompted by an investigative report by David Willman of the Los Angeles Times (December 7, 2003), who uncovered conflicts of interest of unprecedented magnitude among 94% of the highest paid scientist at institutes of the NIH. The article also uncovered abuse of patients in clinical trials. See: http://www.latimes.com/news/nationworld/nation/la-na-nih7dec07,1,7108097.story?coll=la-home-headlines

The Washington Post reports about an example uncovered by the House subcommittee investigation of a high NIH official who received secret fees: “drug giant Pfizer Inc. reported that Trey Sunderland, a researcher at the National Institute of Mental Health, was paid $517,000 in fees, honoraria and expense reimbursements related to consulting arrangements with the company over the past five years. Greenwood said the information was not on Sunderland’s financial disclosure reports as required by federal ethics rules. An NIH official said Sunderland was traveling abroad and could not be contacted.”

Given the scope of the violations throughout NIH, it is doubtful that Trey Sunderland is the only official at the NIMH who was involved in secret financial deals with pharmaceutical companies. The Alliance for Human Research Protection (AHRP) is concerned about recent revelations involving concealed evidence of attempted suicides by teens in antidepressant drug trials, and the role of NIMH in that concealment. AHRP has twice submitted written letters of concern to Dr. Thomas Insel, director of the NIMH (copies to Dr. Zerhouni) questioning NIMH’s role in the concealment of adverse clinical trial data (April 30 and on June 23, 2004).

AHRP discovered in FDA documents that at least two teenagers enrolled in an NIMH-sponsored Prozac trial, attempted suicide. The published report of that trial failed to disclose any suicide attempts. Additionally, AHRP discovered in FDA’s medical review, that this taxpayer funded trial was “part of [Eli Lilly’s] pediatric development program for fluoxetine” to gain FDA approval for children. See: Food and Drug Administration (FDA). Center for Drug Evaluation and Research (CDER). June 25,, 2001. Application number 18-936/SE5-064. Medical Review by Andrew Mosholder, MD. Posted on FDA’s website Sept. 25, 2003: http://www.fda.gov/cder/approval/index.htm

We believe these revelations suggest the need for a thorough investigation of NIMH officials’ financial ties to drug companies–and the agency’s possible misappropriation of public funds. The Wall Street Journal reports that lobbyists from academia and elsewhere sense the chilly new atmosphere toward NIH. There is “NIH fatigue” on Capitol Hill, one lobbyist says, and “lots of pushback” from once-friendly members of Congress and their staffs.”

Oddly, The New York Times has not seen fit to report about the corrupt practices that have tainted NIH’s credibility. Yet, the Times does report on its front page about the pervasive corrupting influence of the pharmaceutical industry on individual physicians who accept $10,000 kick-backs. See: As Doctors Write Prescriptions, Drug Company Writes a Check, By Gardiner Harris http://www.nytimes.com/2004/06/27/business/27DRUG.final.html?hp

The most damaging corrupting influence of the pharmaceutical industry on the culture of medicine and the safety of prescription drugs, is its influence on science and scientists at elite medical research institutions. If scientists at prestigious institutions get away with concealed financial deals with companies whose products they proclaim to be “safe and effective” by reporting partial data, why would anyone expect ordinary physicians who are under pressure from HMOs to be less susceptible to pharmaceutical company bribes and kickbacks?

Contact: Vera Hassner Sharav
Tel: 212-595-8974


Washington Post
NIH Scientists Broke Rules, Panel Says
Deals With Companies Went Unreported, Probe of Potential Conflicts of Interest Finds
By Rick Weiss
Wednesday, June 23, 2004; Page A19

Researchers at the National Institutes of Health violated federal rules by engaging in lucrative collaborations with pharmaceutical and biotechnology companies and not reporting those arrangements to ethics officials as required, according to documents released yesterday as part of an escalating congressional investigation into conflicts of interest at the agency.

The House oversight subcommittee had already identified several instances in which scientists engaged in outside activities that posed at least the appearance of a conflict of interest. But in those cases the arrangements had been approved by top legal and ethics officials. Now, NIH officials said, disciplinary actions may be needed.

Testimony yesterday also provided evidence that Lance A. Liotta, a researcher at the National Cancer Institute, continued to receive thousands of dollars in compensation from one such business arrangement through May, despite his testimony under oath last month that he had suspended the collaboration months before.

The subcommittee said Liotta and others used their government computer systems to exchange e-mails relating to their private consultancies, supporting some lawmakers’ contention that some government scientists have been illegally using federal resources for personal gain.

It remains to be seen how many of the subcommittee’s allegations will stand up to closer scrutiny as bona fide breaches of ethics rules. Many details of the cases were still missing as of yesterday, and key individuals could not be reached to comment after the hard-hitting six-hour hearing came to a close.

But having learned of some of the new findings late last week, NIH Director Elias A. Zerhouni came before the subcommittee yesterday with proposed revisions to NIH ethics rules more severe than those he had recommended a month earlier. “I have reached the conclusion that drastic changes are needed,” he said.

The new allegations emerged as part of the panel’s expanding investigation into government employees’ consulting deals with private companies. Although House members began by focusing on NIH, where top scientists’ spare time is in great demand by drug companies wishing to capitalize on their expertise, they widened their probe last week to include 15 other federal agencies. In letters sent to agency heads, the subcommittee chairman, James C. Greenwood (R-Pa.), and House Energy and Commerce Committee Chairman Joe Barton (R-Tex.) asked that records of all such collaborations be provided to them by July 2.

Yesterday’s surprise disclosure that many NIH scientists may be engaging in outside deals without the required agency reviews and approvals grew from inquiries Greenwood made to 20 pharmaceutical companies. Given the lack of a centralized NIH database of all agency scientists’ outside collaborations, Greenwood went directly to the companies, asking them to reveal all the arrangements they had. Of the 264 arrangements the companies reported, Greenwood said, “about 100” were apparently unknown to NIH officials. That sampling has Congress wondering, “What else is out there?,” said Rep. John D. Dingell (D-Mich.).

In one example detailed by Greenwood, drug giant Pfizer Inc. reported that Trey Sunderland, a researcher at the National Institute of Mental Health, was paid $517,000 in fees, honoraria and expense reimbursements related to consulting arrangements with the company over the past five years. Greenwood said the information was not on Sunderland’s financial disclosure reports as required by federal ethics rules.

An NIH official said Sunderland was traveling abroad and could not be contacted. In another highlighted arrangement, Alan Moshell of the National Institute of Arthritis and Musculoskeletal and Skin Diseases was retained as an expert witness in several private product-liability lawsuits involving the drug Accutane at a rate of $600 per hour — and did so without required agency permission — Greenwood said. Those arrangements were described by Health and Human Services general counsel Alex M. Azar II as particularly worrisome as Moshell allegedly testified in those trials to the inadequacy of the government’s own warning label on the drug.

Moshell did not respond to calls and an e-mail late yesterday. The subcommittee also provided new details regarding an alleged conflict of interest outlined in a May hearing, in which cancer researcher Liotta and an FDA scientist became paid consultants for a California biotechnology company that is in competition with a Bethesda company with which the two scientists and the Cancer Institute were already collaborating. Liotta testified last month that by March of this year he had suspended the California arrangement, pending a fresh ethics review by agency officials who initially approved the deal but later expressed regret at having done so.

Yesterday, Greenwood flashed on a giant screen copies of several canceled checks from the company — Biospect Inc. of South San Francisco, recently renamed Predicant Biosciences — made out to Liotta. The latest check, for $3,125, was dated May 1. Greenwood also showed evidence supplied by the company that it had paid Liotta a total of $70,000, significantly more than the approximately $49,000 that Liotta reported to ethics officials.

A cancer institute spokesman said yesterday that Liotta had an appointment and would not be able to respond to media queries.

Zerhouni has already imposed new tiers of ethics review for all proposed outside consulting arrangements by NIH employees and greater public disclosure of approved arrangements. Yesterday, he proposed additional restrictions, including some that could be accomplished internally and others that may require new legislation.

Among them: a ban on ownership of drug company or biotech stocks by some key employees, and restricted stock ownership for all other employees; no membership on corporate boards; creation of a centralized registry of all outside arrangements and a public list of the awards that employees may receive; and prohibition of all paid consulting or speaking engagements at institutions that receive NIH funding.

C 2004 The Washington Post Company

The Wall Street Journal
Bernard Wysocki Jr., National Institutes of Health Is Under Fire;
Longtime Favorite of Congress Grapples With Slim Funding Increases, Conflicts Inquiry
Wall Street Journal
Jun 22, 2004 p. A.4

Washington — THE NATIONAL INSTITUTES of Health, long a sacred cow in Washington, is coming under fire from the very Congress that once showered it with funds. After doubling its annual budget to $28 billion in the past five years, Congress has given NIH tiny increases this year, as large fiscal deficits force budget tightening. Meanwhile, lawmakers are pressing agency officials to explain how they spend all the money — and why there isn’t more bang for these bucks.

More ominously for the agency, congressional investigators have launched a high-profile probe into the outside activities of NIH scientists, many of whom already enjoy special exemptions from civil- service salaries and command salaries of as much as $200,000 a year. The congressional probe is delving into potential conflicts of interest within NIH, following disclosures that scores of NIH scientists enjoy lucrative consulting relationships, often with pharmaceutical and biotechnology companies.

A House subcommittee will hold the third in a series of hearings on these sometimes-lucrative outside activities today. Lawmakers are expected to make public a list of 122 awards and prizes given to NIH scientists and administrators since 1999, totaling about $575,000. In 34 cases, the House documents show, the money came from universities and other institutions that get NIH grants, creating at least the appearance of impropriety in some cases, House investigators say.

It is an unusual battering for NIH, whose 27 component institutes and centers have long been admired as the crown jewel of America’s biomedical research effort. Several steps taken by Elias Zerhouni, the director of NIH since 2002, to put some restrictions on outside activities have failed to mollify lawmakers.

“When people get awards from a grantee, there’s at least the appearance of conflict of interest,” says Rep. Jim Greenwood (R., Pa.) chairman of the House subcommittee. He said Dr. Zerhouni is expected to come before the panel today and make proposals covering awards and outside consulting. “In the main, they are pretty darn good.”

Some committee members have openly scoffed at the recommendations of a blue-ribbon commission appointed by the 53-year-old NIH director. This clearly caught Dr. Zerhouni, a former senior administrator at Johns Hopkins University in Baltimore, off guard, since he believes the blue-ribbon panel recommended “draconian” steps, including limiting the size of consulting fees from industry and banning outside consulting activity by high-ranking NIH officials.

NIH is in the spotlight for more than the conflict-of-interest investigations. The huge increase in funding has prompted legislators to demand high-profile results against diseases. The impatience crops up repeatedly, as members of Congress often emphasize to NIH officials that its vast research should ultimately translate into treatment for diseases.

Further denting its image, lawmakers are using the NIH as a springboard into a wider investigation of ethics in government. Friday, the House Energy and Commerce Committee expanded the conflict- of-interest inquiry beyond NIH to 15 federal agencies. “Our goal is to learn whether the practices we have uncovered at NIH also exist in other agencies,” Rep. Joe Barton (R., Texas) the committee chairman, said Friday. Dr. Zerhouni in a recent interview said he had grave misgivings about a complete ban on outside activities, particularly on payments for writing and speaking. “If that’s under attack,” he said, “then we have a real issue.”

The NIH guidelines on outside activities were loosened by Dr. Zerhouni’s predecessor, Harold Varmus, in 1995, when, Dr. Varmus says, NIH was having trouble recruiting top private-sector talent. Dr. Varmus, now president of Memorial Sloan-Kettering Cancer Center in New York, says a new NIH vaccine center couldn’t have recruited 10 top scientists recently without the enticements of high pay and outside income.

Gary Nabel, director of the vaccine center, says 80% of these critical subordinates do outside speaking and writing, and about half do outside industry consulting for pay. Dr. Nabel himself has consulted on gene therapy in cardiovascular disease. It is an area of expertise that he says doesn’t conflict with his current job, which is to oversee development of vaccines for the AIDS, Ebola and other viruses. Dr. Nabel says he hasn’t had any turnover among the top people recruited over the past five years. However, he says, if a ban on all outside activity is imposed, “the most talented people” would be tempted to leave NIH.

Several members of the House subcommittee investigating NIH remain skeptical. Rep. Diana DeGette (D., Colo.), has repeatedly questioned Dr. Zerhouni about the need for outside compensation by scientists in the civil service. She says she understands why interaction is important but doesn’t see the need for extra pay. While she hasn’t made up her mind on the issue for NIH scientists, Rep. DeGette says, “I think it’s very difficult to enforce conflict-of-interest rules without an outright ban.”

One target of the probe by Congress is Richard Klausner, former director of the National Cancer Institute. In 2002, shortly after he stepped down, the cancer institute awarded a $40 million contract to Harvard University for drug-discovery research. The lead scientist at Harvard later formed a private company, made Dr. Klausner an officer and awarded him stock in the enterprise. Dr. Klausner says he didn’t have any role in awarding the Harvard contract and joined with the private company only after leaving government service. Currently, Dr. Klausner is a senior official at the Bill & Melinda Gates Foundation, which funds infectious-disease research.

In a separate case, several members of Congress lashed into two officials, one of NIH, the other of the Food and Drug Administration, who worked together in their official capacities with one biotech company while moonlighting for a competitor. Both officials stopped the moonlighting, after protests. More witnesses are expected to come before the House panel this morning.

The agency’s growing budget has brought it a different kind of scrutiny. Some legislators see it as never satisfied. Sen. Pete Domenici (R., N.M.) raised eyebrows this spring when he said NIH has “turned into pigs.” A recent study by the Rand Corp., the California think tank, found that nearly half of the federal research and development budget is going to medical schools.

Lobbyists from academia and elsewhere sense the chilly new atmosphere toward NIH. There is “NIH fatigue” on Capitol Hill, one lobbyist says, and “lots of pushback” from once-friendly members of Congress and their staffs.

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