24 January 2003

ADVISORY PANELS STACKED, SCIENTISTS WARN

Item 1 seems to describe just a slightly more blatant version of what's been going on for a very long time in the U.$. - see item 2 - and in many other places: witness the recent report by an independent consultant to the World Health Organisation on how the food industry has infiltrated the WHO and has been involved in placing scientists favourable to its views on WHO and Food and Agricultural Organisation (FAO) committees.
http://ngin.tripod.com/090103a.htm

1.Advisory Panels Stacked, Scientists Warn
2.Revolving door in U.S:
*The Bush-Monsanto connection
*Insider Trading?
*Revolving doors and FDA regulatory scandals
*The "revolving door" - Edmonds Institute

***

1.Advisory Panels Stacked, Scientists Warn

By J.R. Pegg
http://ens-news.com/ens/jan2003/2003-01-23-10.asp

WASHINGTON, DC, January 23, 2003 (ENS) - American scientists are growing increasingly worried that the Bush administration is manipulating scientific advisory committees in order to further its political agenda.  The federal government relies on hundreds of these committees to provide agencies with unbiased advice based on the best science available as well as to peer review grant proposals for scientific research.

The Bush administration, many scientists fear, has distorted this process by putting committee members through political litmus tests, eliminating committees whose findings looked likely to disagree with its policies, and stacking committees with individuals who have a vested interest in steering conclusions to benefit effected industries.

"We've seen a consistent pattern of putting people in who will ensure that the administration hears what it wants to hear," said Dr. David Michaels, a research professor in the Department of Environmental and Occupational Health at George Washington University's School of Public Health. Addressing reporters at a press briefing today in Washington, Dr. Michaels said, "That doesn't help science, and it doesn't help the country." The Bush administration says it is doing what every other administration has done in the past, but many scientists take issue with this defense.

"The Clinton administration did not do this," said Dr. Lynn Goldman, a pediatrician and professor at the Bloomberg School of Public Health at Johns Hopkins University. "They did not exclude people based on some sort of litmus test."

"These are not just the concerns of a few scientists or members of the public health community but of a broad array of people across the country," added Kelly O'Brien, associate executive director of public affairs for the American Public Health Association (APHA).

The role of these committees is not to tell the administration what they want to hear, Michaels argues, but to tell them what science has concluded about the issue under discussion.

"You hire political appointees to move your political agenda forward," he observes. "But the role of scientific advisory committees is quite different. It is to give advice to the agencies and to the public on what is the best science."

"This is a threat to the fundamental principles that we want to make decisions based on the best available science," Goldberg added.

Americans may be unfamiliar with the role of scientific advisory committees, but the impact of the advice they give is extensive. Rules and regulations that govern clean air, clean water, food safety and pesticide use, among others, have been devised with scientific advice from such committees.

The growing concern from American scientists comes from a slew of examples. Members of the Center for Disease Control's (CDC) Advisory Committee on Childhood Lead Poisoning Prevention were replaced last year with individuals with close ties to the lead industry, including Dr. William Banner, who has provided written testimony on behalf of lead industry defendants in a lawsuit in Rhode Island.

Banner is on record as believing that lead is only harmful in levels that are seven to 10 times higher than the current CDC blood lead levels. The CDC estimates some 890,000 U.S. children ages one to five have elevated levels of lead in their blood.

Fifteen of the 18 members of the Advisory Committee to the Director of the National Health Center for Environmental Health were replaced last year. This committee assesses the health impact of exposure to environmental chemicals. Among the new members is the former president of the Chemical Industry Institute for Toxicology.

Tommy Thompson, Secretary of the Department of Health and Human Services (HHS), dissolved a committee charged with analyzing the federal system for protecting human research subjects. A committee tasked with giving the U.S. Food and Drug Administration advice on oversight of the genetics testing industry was similarly disbanded.

A respected scientist nominated to serve on an HHS peer review study section, which is charged with reviewing research grant proposals submitted to the National Institute for Occupational Safety and Health, was rejected for her support of an ergonomics rule overturned by the Bush administration last year.

A consultant to the Army Science Board was disapproved for full membership on the committee because, he was told, he contributed to Senator John McCain's campaign, an allegation that was false.

A new member of the Food and Drug Administration's Reproductive Health Drugs Advisory Committee, Dr. David Hager, helped the Christian Medical Association lobby for a safety review of a drug the committee approved two years ago. The announcement that Hager, who has very few research credits, had been put on the committee was released on Christmas Eve.

The trouble with this politicization of the process by which scientists advise the government, Michaels explained, is that they will directly impact the government's willingness to act.

"I don't think there is really any danger of a committee coming out and making a statement so far out of the mainstream that it takes us in a different direction," he explained. "What these committees will do, and I think this is what the administration wants, is to essentially throw their hands up and say there is too much uncertainty. That sort of paralysis is dangerous."

The trust the public has in science, and in the scientific advice offered by the government for public health issues, could be gravely affected by these developments, said Dr. Martin Apple, president of the Council of Scientific Society Presidents.

"Public trust is like Humpty Dumpty," Apple said. "It is difficult to establish, easy to lose and nearly impossible to restore."

It is not that anyone expects scientific advisory committee members to be completely unbiased, Goldman said. Rather, it is critical that these committees are focused only on the science, leaving political, economic and religious bias out of the equation.

"If you attempt to predetermine the outcome of the scientific discussion by selecting certain people for science committees or by constructing a consensus before you bring the group together, then you are distorting the process," Goldman added. "For the past several months, again and again with this current administration, we've seen evidence of this occurring."

Goldman, who served as the assistant administrator for the Office of Prevention, Pesticide and Toxic Substances within the Environmental Protection Agency (EPA) from 1993 to 1998, has firsthand experience with the Bush administration's policy on scientific advisory committees. Goldman and two other experts on the effects of pesticides on children were invited to speak at an EPA funded conference that was scheduled for September 2002.

In July 2002, representatives from the pesticides industry wrote to the EPA to protest the conference and specifically the participation of Goldman and the other two scientists at the event. The EPA then rescheduled the conference for June 2003 and has not re invited any of the three.

The overarching concern, Goldman said, is the apparent influence of the pesticide industry on the EPA.

California Representative Henry Waxman, a Democrat, agreed and sent EPA Administrator Christie Todd Whitman a letter on December 20, 2002 asking for an explanation by January 6, 2003. Waxman's spokesperson Karen Lightfoot told ENS that the Congressman has not received any response from the EPA.

In late October 2002, Waxman and 11 other members of Congress sent a letter to HHS Secretary Thompson, detailing concern with "a pattern of events . suggesting that scientific decision making is being subverted by ideology and that scientific information that does not fit the administration's political agenda is being suppressed."

HHS did reply to Waxman and his colleagues, but their explanations did not satisfy the letter writers. A subsequent letter asking for more detailed information was sent on December 18, 2002.

Lightfoot said there has been no response to the December 18 letter, but added that Congressman Waxman will closely monitor "this trend of putting ideology before science."

Groups like the American Public Health Association, which has some 50,000 members, are calling on Congress to further explore just what the Bush administration is doing with scientific advisory committees. APHA drafted a series of recommendations, including the reevaluation of newly reconstituted advisory panels and the creation of criteria to guide the selection of members on public health advisory committees and peer review research committees at all levels of government - federal, state and local.

There is concern that if the process continues forward without serious review that many qualified scientists will decline to involve themselves with future committees.

"Scientists and the federal government in the United States have established an effective system of providing expert advice," Apple said. "But the best scientists are only willing to serve on such advisory groups when they believe that they are unbiased and will produce scientifically sound results. Once this currency is debased, the best scientists will decline to take the time out from their lives to participate, and the government will lose an irreplaceable resource."

"This will cause severe and last damage to the national interest and should be actively prevented," Apple urged.

There is "no glory" for scientists to take part in the vast majority of scientific advisory committees, Michaels said. They are only compensated for travel and accommodations, and the work is often long and tedious.

"It is quite possible that these are isolated, anecdotal incidents," Goldman suggested. "But then why hasn't there been an attempt to rectify them?"

***

2.Multiple items on revolving door between biotech and government in the U.S.

*The Bush-Monsanto connection
*Insider Trading?
*Revolving doors and FDA regulatory scandals - url
*The "revolving door" - Edmonds INstitute
...
The Bush-Monsanto connection

THE PLOT THICKENS
http://www.purefood.org/Monsanto/MonBushAdmin.cfm
Comments by Robert Cohen

During the 2000 election cycle, Monsanto gave a total of only $63,350 to Congress...on the record. Nobody will ever know what amounts were invested in the form of soft money, cash money, party favors, and gifts. The $63,350 paid to 435 members of Congress, and 100 members of the Senate averages out to $118 per member. Sure. I believe that.

The man receiving the SECOND highest total dollars from Monsanto was Larry Combest (R-TX). He got $2000. Combest is the powerful chairman of the House Agriculture Committee.

Who got the most from Monsanto? The winner of the Monsanto sweepstakes with $10,000 was: John Ashcroft, (R-MO). Ever hear of the man? You will in the coming weeks during the Senate's confirmation hearings. [see below]

Now...for those of you who are not regular readers of the notmilk column, let's review the Bush/Monsanto connection.

First. Monsanto's lawyer [Clarence Thomas ] was appointed to the Supreme Court by George Bush, Sr. The deciding swing vote giving the election to George, Jr. was made by Clarence Thomas, Esq.

Second. Donald Rumsfeld, Secretary of Defense [headed Searle] purchased by Monsanto.

Third. Ann Veneman, Secretary of Agriculture was on the board of directors of Calgene Pharmaceuticals, purchased by Monsanto.

Fourth. Tommy Thompson, Secretary of Health was a supporter of Monsanto in Wisconsin. He received $50,000 from Biotech firms is his election run, and used state funds to set up a a $317 million dollar biotech zone in Wisconsin.

Fifth. Mitch Daniels, Director of the Office of Management and Budget. Daniels was the vice president of corporate strategy at Eli Lilly Pharmaceutical company. Eli Lilly and Monsanto developed the genetically engineered bovine growth hormone. Lilly "owns" the European "franchise." Daniels presence insures that the bovine growth hormone will one day be approved for use in Europe.

Sixth. Last, but not least. John Ashcroft, Attorney General. Winner of the Monsanto PAC sweepstakes.

What will America's prize be?

Robert Cohen
...
Insider Trading? [Excerpt from a speech by Ann Clark Genetically Engineered Crops: A Luddite's View,  - the full text can be seen at:
http://www.oac.uoguelph.ca/www/CRSC/faculty/eac/biotech.htm]

"....Insider Trading? It is difficult to envision how government decisions can be made impartially and objectively - with societal and environmental interests in the forefront - when people in positions of high authority frequently have such strong ties to industry. A brief listing of key people who have migrated between the biotech industry and the USDA, the FDA, or the EPA in recent years would include Linda Fisher (EPA to Monsanto); Val Giddings (USDA to BIO), Terrence Harvey (FDA to Monsanto), Margaret Miller (Monsanto to FDA), Keith Reding (USDA to Monsanto), Michael Taylor (lawyer representing Monsanto to USDA), and Sally Van Wert (USDA to AgrEvo). These are not bench scientists, but people with key, governmental regulatory positions, often over the very products they are/were involved with in industry. In depth discussion of the forces which have influenced the agricultural policymaking process in the US and in the US vs. UK may be found in Wargo (1996) and Wright (1994), respectively."
...
Revolving doors and FDA regulatory scandals - Ecologist article (Sept/Oct 98) http://www.psrast.org/ecologmons.htm
...
The "revolving door" - the industrial alignment of public service and regulatory authorities (see also Ann Clark's comments above) taken from the Edmonds Institute: http://www.edmonds-institute.org/door.html

David W. Beier . . .former head of Government Affairs for Genentech, Inc., . . .now chief domestic policy advisor to Al Gore, Vice President of the United States.

Linda J. Fisher . . .former Assistant Administrator of the United States Environmental Protection Agency's Office of Pollution Prevention, Pesticides, and Toxic Substances, . . .now Vice President of Government and Public Affairs for Monsanto Corporation.

Michael A. Friedman, M.D. . . former acting commissioner of the United States Food and Drug Administration (FDA) Department of Health and Human Services . . .now senior vice-president for clinical affairs at G. D. Searle & Co., a pharmaceutical division of Monsanto Corporation.

L. Val Giddings . . . former biotechnology regulator and (biosafety) negotiator at the United States Department of Agriculture (USDA/APHIS), . . .now Vice President for Food & Agriculture of the Biotechnology Industry Organization (BIO).

Marcia Hale . . . former assistant to the President of the United States and director for intergovernmental affairs, . . .now Director of International Government Affairs for Monsanto Corporation.

Michael (Mickey) Kantor. . . former Secretary of the United States Department of Commerce and former Trade Representative of the United  States, . . .now member of the board of directors of Monsanto Corporation.

Josh King . . . former director of production for White House events, . . . now director of global communication in the Washington, D.C. office of Monsanto Corporation.

Terry Medley . . . former administrator of the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture, former chair and vice-chair of the United States Department of Agriculture Biotechnology Council, former member of the U.S. Food and Drug Administration (FDA) food advisory committee, . . . and now Director of Regulatory and External Affairs of Dupont Corporation's Agricultural Enterprise.

Margaret Miller . . . former chemical laboratory supervisor for Monsanto, . . .now Deputy Director of Human Food Safety and Consultative Services, New Animal Drug Evaluation Office, Center for Veterinary Medicine in the United States Food and Drug Administration (FDA).*

Michael Phillips . . . recently with the National Academy of Science Board on Agriculture . . . now head of regulatory affairs for the Biotechnology Industry Organization.

William D. Ruckelshaus . . . former chief administrator of the United States Environmental Protection Agency (USEPA), . . .now (and for the  past 12 years) a member of the board of directors of Monsanto Corporation.

Michael Taylor . . . former legal advisor to the United States Food and Drug Administration (FDA)'s Bureau of Medical Devices and Bureau of  Foods, later executive assistant to the Commissioner of the FDA, . . . still later a partner at the law firm of King & Spaulding where he supervised a nine-lawyer group whose clients included Monsanto Agricultural Company, . . . still later Deputy Commissioner for Policy at the United States Food and Drug Administration, . . . and later with the law firm of King & Spaulding. . . . now head of the Washington, D.C.  office of Monsanto Corporation.*

Lidia Watrud . . . former microbial biotechnology researcher at Monsanto Corporation in St. Louis, Missouri, . . .now with the United States Environmental Protection Agency Environmental Effects Laboratory, Western Ecology Division.

Jack Watson. . .former chief of staff to the President of the United States, Jimmy Carter, . . .now a staff lawyer with Monsanto Corporation in Washington, D.C.

Clayton K. Yeutter . . . former Secretary of the U.S. Department of Agriculture, former U.S. Trade Representative (who led the U.S. team in negotiating the U.S. Canada Free Trade Agreement and helped launch the Uruguay Round of the GATT negotiations), now a member of the board of directors of Mycogen Corporation, whose majority owner is Dow AgroSciences, a wholly owned subsidiary of The Dow Chemical Company.

Larry Zeph . . . former biologist in the Office of Prevention, Pesticides, and Toxic Substances, U.S. Environmental Protection Agency, . . . now Regulatory Science Manager at Pioneer Hi-Bred International.

*Margaret Miller, Michael Taylor, and Suzanne Sechen (an FDA "primary reviewer for all rbST and other dairy drug production applications")  were the subjects of a U.S. General Accounting Office (GAO) investigation in 1994 for their role in the U.S. Food and Drug Administration's approval of Posilac, Monsanto Corporation's formulation of recombinant bovine growth hormone (rbST or rBGH). The GAO Office found "no conflicting financial interests with respect to the drug's approval" and only "one minor deviation from now superseded FDA regulations". (Quotations are from the 1994 GAO report).