By David Michaels
Marla Cone, in the Los Angeles Times, reports on a complaint raised by the Environmental Working Group (EWG) that the National Toxicology Programâs Center for the Evaluation of Risks to Human Reproduction (CERHR) is being run not by federal scientists but by a consulting firm that also works for manufacturers of chemicals CECHR is charged with evaluating.
EWGâs charges are true, but not surprising if youâve ever worked in a federal agency. The number of government activities that are actually performed by contractors is enormous and growing rapidly. CERHR, whose mission is to provide âscientifically-based, uniform assessments of the potential for adverse effects on reproduction and development caused by agents to which humans may be exposedâ is operated by Sciences International, a private consulting firm owned by Tetratech, one of the giant contracting firms.
The Los Angeles Times article focuses on an upcoming CERHR evaluation of the controversial plasticizer bisphenol A (BPA). This is a widely used chemical found in numerous independent studies to have âendocrine disruptingâ effects at low doses; chemical industry-funded studies, in contrast, always find it to be harmless at these levels. According to the article, Sciences International
produces the first draft of the center's reports on the risks of chemicals, including a new one on bisphenol A, a widely used compound in polycarbonate plastic food containers, including baby bottles, as well as lining for food cans.
The center's work is considered important to public health because people are exposed to hundreds of chemicals that have been shown to skew the reproductive systems of newborn lab animals and could be causing similar damage in humans. Chemical companies and industry groups have staunchly opposed regulation of the compounds and have developed their own research to dispute studies by government and university scientists:
The bisphenol A report, which some scientists say has a pro-industry bias, is a public document scheduled for review by the center's scientific panel on Monday. Employees of Sciences International involved in writing it will preside over the meeting.
EWG has questioned whether Sciences International, which has worked for numerous chemical manufacturers, can be trusted to run (and thatâs what contractors do) this evaluation. Itâs a great question. Sciences International is not a hack company; it employs some very respected scientists who do excellent work.
On the other hand, the company was involved in a sleazy attempt by the tobacco industry to back the EPA away from controlling exposures to a pesticide used in tobacco, and used its work for government agencies to land this contract. The episode is the subject of an important paper published in Environmental Health Perspectives in 2005. EWG has posted a provocative letter to a tobacco industry executive from Sciences International's founder and then President Dr. Elizabeth Anderson. The letter is a sales pitch, extolling the fact that the company "is different from most other consulting firms in that we also currently serve government agencies." (Dr. Anderson has since left Sciences International. She is now Group Vice President of Exponent, Inc., one of the nation's top "product defense" firms.)
The Los Angeles Times article explains that
Debate over BPA is one of the most contentious environmental health issues faced by government and industry. Traces are found in the bodies of nearly all Americans tested, and low levels â similar to amounts that can leach from infant and water bottles â mimic estrogen and have caused genetic changes in animals that lead to prostate cancer, as well as decreased testosterone, low sperm counts and signs of early female puberty, according to more than 100 government-funded studies. About a dozen industry-funded studies found no effects.
Fred vom Saal, a University of Missouri-Columbia scientist conducting NIH-funded BPA research, said the draft report written by Sciences International downplays the risks of the plastics chemical and makes critical mistakes.
"It's a combination of inaccurate information and blatant bias as it exists in its draft form," vom Saal said. "They specifically ignore fatal flaws in industry-sponsored publications." He said the 300-page report misrepresented government-funded studies that found effects by inaccurately portraying their findings, and failed to note industry funding of some studies cited.
[Michael] Shelby, the center's director, in a late February memo to the Environmental Working Group, said Sciences International reviews the scientific literature on chemicals and writes the basic reports, but that conclusions are prepared by the center's panel of independent scientists, which "serves to minimize or eliminate any bias that might possibly be introduced by the contractor."
Shelby wrote that there are no requirements for Sciences International or other contractors to disclose financial conflicts of interest.
When work that should be done by federal employees is given to private sector companies, the public usually gets the short end of the stick. In Iraq, private firms have been living high off of federal budget, paid too much and producing low quality work. Congressman Henry Waxman is investigating the link between recent privatization of services at Walter Reed Army Medical Center and the abysmal treatment provided Iraq war wounded. The examples go on and on and on.
Poor work quality aside, contractors are always thinking about where the next contract will come from. The too frequent result is that they watch out for their own interest over those of the tax-payer. Thatâs simply the way the world works.
Federal dollars are given to contractors who may be working for private companies that have an interest in the results. If a contractor is competing for both US and private dollars, conflict of interest is virtually inevitable.
To me, the answer is pretty clear. The federal government needs to ensure it gets the best, unconflicted science. Conflict of interest is pernicious; even when the process is fair and the outcome not influenced, the taint of conflict reduces the credibility and therefore the usefulness of the product.
UPDATE: The CERHR meeting on bisphenol A is getting quite a bit of press coverage. The St. Louis Post-Dispatch has an article on the dispute over its safety, and today's Columbia (Missouri) Daily Tribune has a profile of Dr. vom Saal.
David Michaels heads the Project on Scientific Knowledge and Public Policy (SKAPP) and is Professor and Associate Chairman in the Department of Environmental and Occupational Health, the George Washington University School of Public Health and Health Services.
the NTP insists that the contractor, Sciences International, did no more than manage the administrative functions of the BisA review, though this is in doubt. NTP has now proposed to "solve" the conflict, in this late stage of the game, by removing SI from its administrative duties on this chemical. Unfortunately, this is too little, too late. A broken scientific assessment is now undergoing a scientific review that may provide patches, but is unlikely to rescue this flawed review.
The extramural research programs at agencies such as the NIH and the CDC have had large portions of activity outsourced to private "research and management" firms. This has been done in follow-through of former Vice President Gore's "Reinventing Government" plans, put onto steroids by current Vice President Cheney. You may remember that when W and Dick came to office, they announced a goal of outsourcing 50% of government operations by the time they left office, and that they intended to begin with the Pentagon and the NIH.
Aside from the goal of shrinking government, these measures permit the following:
1. weakening the labor movement by eliminating government workers who belong to unions and whose working conditions are regulated by a union contract. This has the delightful intended side effect of reducing the amount of dues collected and thereby the amount of money that unions have to back labor-supporting candidates. Not to mention the ability to pay workers less and take the balance as corporate profits or as bloated salaries for corporate executives - or even use the money for campaign donations.
2. This also weakens the civil service system, already horribly weakened by years of disregard and neglect. A key purpose of the system was to prevent patronage in government employment and the abuse of government workers for the gain of key politicians.
3. Outsourcing government functions makes politicians and political parties more ripe for bribing with campaign and other donations by companies that want to then get the contracts to do the government work. On the flip side, the political party in power or that hopes to be in power can then go to companies and promise contracts if sufficient support is provided to get party members elected (a kind of blackmail).
The system is set to be ripe for corruption and to reduce democratic oversight and control.
Here are some of my most recent experiences with the system.
A colleague recently contacted someone at NIH to learn about the scoring of a proposal that she had submitted. She was told that the agency is terribly short-staffed and having great difficulty getting participants for peer review panels and so they set the cut-off for scoring proposals at 180 (lower than has normally been the practice). The agency will get to the proposals that score above that within the next few months and will score all and give summaries for the ones that are not far from 200. The agency employee was exasperated. She told my colleague that between the difficulty that they are having reviewing proposals and the reduced funding they receive for awards, they are funding about 1/2 of what they were several years ago. I have experienced similar problems at the National Institute for Occupational Safety and Health which has had a woefully small and overworked staff managing its extramural portfolio.
The other thing that I've noticed is that the private corporations who now do the outsourced work of organizing review panels are themselves submitting proposals to do the research - they are establishing research groups. And, I recently read that these corporations, because of their size and wealth, have lobbyists working Congress to make sure that the work of running the research agencies continues to be outsourced rather than rebuilding internal staffing strength - so that they can continue and expand their business. Constella, one of these corporations working with NIH and CDC has an advisory board that has Tommy Thompson, former Director of the DHHS as the chair and Carol Browner, a former EPA director as a member. Constella received about $150M dollars in management and research support from NIH and CDC last year alone.
In the meantime, academic researchers across the country are finding it increasingly difficult to secure federal research grants. This is due to a combination of budget reductions for the research programs (money is needed for a war based on the lies of an administration that stole two elections to exist, and for drastic reductions in taxation of the wealthiest in our society - corporations and individuals) and ideological barriers put up against what will be funded and who will participate on review panels and science boards.
Take a look at the board of directors of Tetra Tech, the parent corporation of Science International. Albert Smith is the board chairman. Quoting from their web site:
"Mr. Smith is a former member of the Secretary of Defense's Defense Science Board, serving from 2002 to 2005. He was an Executive Vice President of Lockheed Martin and President of its Integrated Systems & Solutions business until 2004. From 1999 to 2003 Mr. Smith was Executive Vice President of Lockheed Martin's Space Systems Company. Prior to that, Mr. Smith was President of Government Systems at Harris Corporation. He has also worked for the Central Intelligence Agency, where he received the Intelligence Medal of Merit. Mr. Smith has served as Chairman of International Launch Services' Board of Directors and as a Director of the Space Foundation."
So, Science International, Constella, Lockheed Martin Government Services, Halliburton and its subsidiaries, are part of the ever expanding network of corporations with directors who have been busy running through the revolving doors between corporations and the federal government. As any corporation, their mission demands that they meet the goals of their investors as well as other fiduciary obligations. Their primary goals cannot be to support public health or the firm democracy that is critical to achieve optimal public health.
In the currently playing German film, The Lives of Others, viewers watch as a character who lived in the former German Democratic Republic (the former East Germany) and after the fall of the Berlin Wall and integration with West Germany is able to review all records collected on him by the former police state. It's powerful to watch this, especially to then realize that here in the US we do not have that liberty. We cannot obtain, for free, the records that government political and police surveillance agencies have collected about us. We have to file Freedom of Information Act requests, pay for the copying fees, only to obtain records that have blacked out because they were deemed as state secrets and security risks.
Public health goals cannot be achieved in a state where democracy is squashed.