Dr. David Graham is a senior official in the U.S. Food and Drug Administration’s Office of Drug Safety — the office responsible for monitoring drugs once they’ve been approved for sale.

Graham, whose medical, epidemiological and biostatistics training was received from the Johns Hopkins University School of Medicine, Yale and the University of Pennsylvania, blew the whistle on Vioxx, after finishing a study that showed the drug had injured and killed tens of thousands of people.

According to Graham the FDA “reacted violently” when he announced he was going to submit his research for peer review. “FDA saw no problem with 100,000 people having heart attacks.”

Senior people in the FDA told him they didn’t want him studying Vioxx and heart attacks. His supervisors called his work “scientific rumour,” and his centre director told reporters that Graham’s study “constitutes junk science.”

The day after his remark Graham’s study was the lead article in the Journal of the American Medical Association. The article was accompanied by an editorial calling for a complete restructuring of the FDA.

Agency officials contacted at least one Senate staffer accusing Graham of being a “liar, cheat, bully, a demagogue and untrustworthy.” At the same time, they contacted a lawyer he obtained through a whistleblower protection group called the Government Accountability Project with the same line of character assassination. His director contacted an editor at The Lancet, accusing Graham of scientific misconduct.

Dr. Graham says the FDA is willing to give a free pass on safety in exchange for its “user fees,” which the pharmaceutical industry pays under the Prescription Drug User Fee Act to reduce the approval time for new drug applications. He says the effect of which is that “our parents and grandparents, our children — all of us — get to be the guinea pigs in that grand experiment while drug companies continue to make profits.” In 2002 the FDA collected fees of $143.3 million of the $209.8 total operating costs for reviewing drugs from the pharmaceutical industry.

Graham charges that the FDA approach to product safety is to “virtually disregard it,” believing there is no risk that cannot be managed “in the post-marketing setting.” FDA’s concept of risk management enables the marketing of unsafe drugs.

His policy prescription is that industry can’t be the client. Public health must be funded by the public for an institution run by and for the public.

“Companies are selling their products to the public and essentially, doing a study on the American people to determine the safety of their products,” he says. “Doing a proper study on drugs like Vioxx takes longer and needs to be much larger than those that serve industry interests. If a drug maker is ringing up $3 billion a year in sales, every day of clinical trials is another day it’s not making $10 million.”

In 2002, two-thirds of FDA scientists surveyed said they weren’t confident that products approved by the FDA were safe, while 18 per cent said they were pressured to change their conclusions on reviews of new drugs.

The Changing Structure of Regulation

What happened to Nancy Olivieri, a researcher at the University of Toronto who warned of liver risks in 1998, and Graham, while dramatic, is symptomatic of much more subtle changes taking place in Canada and the U.S. in the structure of regulation.

The idealized contexts within which publicly-funded scientists would expect to work — where their research would be judged by impersonal criteria, findings were open and shared, motivated by the pursuit of truth, and accepted only after a rigorous process of testing — are being systematically replaced to reflect the requirements of industry.

Now, government regulation of health and safety are seen as barriers to trade, competitiveness and profits.

Reagan’s United States

Mark Blyth (Great Transformations, Cambridge University Press, 2002) describes how the Reagan administration began to deregulate business. For one, they introduced the requirement that all new regulatory proposals would be subjected to a corporate biased cost benefit analysis in order to ensure a calculus where polluters would have to pay less.

Another highly effective strategy was to staff agencies with political appointees “whose ideological convictions were the exact opposites of everything for which the department stood.” For instance, Reagan’s Secretary of the Interior, and the heads of the Environmental Protection Agency, Occupational Safety Health Authority, and National Labour Relation Board were all corporate agents.

A third/fourth strategy was to drain funds and/or lower the standards of the regulatory agencies. Between 1970 and 1980 the budgets of federal regulatory agencies increased by 400 per cent. Between 1981 and 1984 they were cut by 11 per cent overall.

The EPA’s budget fell by 35 per cent and its exposure standards on regulated industrial substances were raised between 10 and 100 times. The staff complement at EPA was reduced from 14,075 to 10,392. Its referrals to the Justice Department for the prosecution of violators decreased by 84 per cent and the number of enforcement orders fell by 33 per cent.

The Food and Drug Administration had its budget cut by 30 per cent over this period and its enforcement orders declined by 88 per cent.

“Between 1981 and 1984, the absolute number of regulations in the Federal Register declined by 25 per cent, and since 1984, no new permanent regulatory department has been authorized or established by the federal government.”

Canada & the Move to Abdicate the Health Protection Duty

In 1997, the Canadian Health Care Coalition reports that Canada’s Bureau of Drug Research was quietly dismantled and facilities for independent lab investigations of pharmaceutical products destroyed. The agency’s scientists were recognized internationally for independent research on drug quality, toxicity, bioequivalence and clinical application of drugs. It was at this juncture that Dr. Michelle Brill-Edwards resigned as the head of the pediatrics branch because she could no longer assure the Canadian public of the efficacy of new drugs that now relied on the pharmaceutical companies to ensure their safety.

Also in 1997, food safety research was terminated and labs were secretly dismantled. Projects cut included: investigations into detection of deadly microorganisms and harmful bacteria, toxic chemicals, preservatives, pesticides, residues of volatile contaminants, additives, herbicides, insecticides, fungicides, glass particles and insect parts and genetically modified organisms in food.

In February 1997, according to the Canadian Health Care Coalition, Health Protection Branch drug reviewers were instructed that the client is the company who pays for the service. “By adopting a client focus and service orientation, regulatory organizations can help those seeking approval to comply with regulations as easy as possible, promote voluntary compliance, earn goodwill from the regulated community, ... and improve the working atmosphere.” The bulletin also says: “there is no conflict of interest between delivering a service to a client and functioning in a regulatory environment.”

NAFTA — Chapter 11

Chapter Eleven of the North American Free Trade Agreement provides corporations with the unprecedented capacity to challenge the powers of government to protect its citizens, “to undermine environmental and health laws, even attack our system of justice.” (Bill Moyers, Trading Democracy)¹ That is, corporations can now sue governments and overturn their judgements in spite of the best evidence of their scientists about their citizens’ health.

Here are two examples of how Chapter 11 cases have become social determinants of health:

The Ethyl Corporation, an American manufacturer of a gasoline additive (MMT), considered by the Canadian government to be carcinogenic and banned, sued the Canadian government under Chapter Eleven. The Ethyl Corporation claim was launched in 1996 and settled in 1998 after a Tribunal made three awards. As part of the settlement, the Government of Canada removed the ban, was forced to issue a statement that there was no evidence of harm caused by the product and to pay the company approximately $20 million (Canadian) because of lost profits. MMT is banned in many U.S. states and in Europe.²

Methanex is a Canadian company that is the world’s leading producer of methanol, the key ingredient in the gasoline additive MTBE or methyl tertiary butyl ether. In 1995 MTBE began turning up in wells throughout California, and by 1999 had contaminated 30 public water systems. The state ordered the additive be phased out, after several studies linked it to cancer and other human health problems. Methanex filed suit under NAFTA’s Chapter Eleven, seeking $970 million in compensation for loss of market shares and, consequently, future profits. This case has not yet been settled.

In each of these cases, scientists in the U.S. and Canada argued that these chemicals should be banned in the interest of public health. With the signing of NAFTA, science was to be judged by trade lawyers, with lost profits as a primary consideration in the determination of the environmental impact of chemicals.

What’s Next — Smart Regulations?

There are two Liberal bills pending in Canada, C-27 and C-28 both part of the government’s Smart Regulation initiative.

According to Barbara Sibbald of the Canadian Medical Association Journal, the initiative is intended “to guide federal health and safety regulations pertaining to everything from pharmaceuticals to agricultural seeds.” Intended to modernizing the regulatory system, it is also designed to “foster an economic climate that promotes innovation and investment.” The initiative’s guiding principles include effectiveness, cost-efficiency, timeliness, transparency, accountability and performance. Environmental protection as well as health protection would be subject to “smart” regulation.

Critics argue that within the regulation framework, corporations would no longer be responsible for proving their products are safe. New foods, drugs and technologies would be presumed safe by Health Canada unless proven otherwise.

Bill C-27 would allow the Canadian Food Inspection Agency to accept testing and certification results from other countries. That means if the FDA authorized a food for consumption it could be sold in Canada.

Critics contend that public safety will be subservient to economic goals. While the Smart Regulation initiative emphasizes timeliness, precautionary values require science to understand the risks, and this takes time.

Shiv Chopra, who along with colleagues Margaret Haydon and Gerard Lambert, blew the whistle on conflicts of interest in Health Canada’s drug approval process, describes the Smart Regulation legislative renewal project, which includes Bill C-27, as the “corporatization of knowledge.”

And according to Mike McBane of the Canadian Health Care Coalition, Bill C-28 would give the minister of health the interim marketing authority to expose Canadians to chemicals, food additives, pesticides and veterinary drugs without first receiving sufficient scientific data to assess the health effects of these products.

“Regulatory competitiveness,” “flexibility in managing health risks,” “cost-effective health protection” and “shared responsibility” are the language of the new regulatory regime.

The role of science in analyzing and predicting in the public interest through universities and government agencies (the HPB in Canada and the FDA in the U.S.) is in the process of qualitative institutional change.

REACH

The European Union has responded to this new North American pro-business regulatory regime with REACH — Registration, Evaluation and Authorization of Chemicals.

According to Mark Schapiro of The Nation, the REACH directive represents an upheaval in the basic philosophy of chemical regulation, flipping the American presumption of “innocent until proven guilty” on its head by placing the burden of proof on manufacturers to prove chemicals are safe — what is known as the “precautionary principle.”

“Under REACH, chemicals determined to be ‘carcinogens, mutagens or repro(ductive) toxins’ would have to be taken off the market within a decade. According to the EPA’s own standards, this could amount to as many as 1,400 chemicals.”

Not only will the raw data be analyzed by scientists but also “the test results that were once tightly held by chemical companies will suddenly be available to citizens and regulators across the globe.”

The American Chemical Council and the State Department claimed that REACH would be “unworkable in its implementation, (would) disrupt global trade and adversely impact innovation.”

According to Schapiro, those assertions have been vigorously disputed by the EU. The EU claimed that the costs of implementing the European regulatory approach would be offset over time by profits generated from safer alternatives and compare favourably to the billions it estimates would be saved in chemical-related health costs alone over the next three decades.

It seems that at least in Europe a new cost benefit analysis is being undertaken with the full social and economic costs of toxic substances to be incorporated into a new regulatory regime.

REACH will mean that in Europe scientists like Olivieri and Graham will be able to work in the public interest independently of industry. Unfortunately for us, we have to eat, drink, breath and take our medicine in North America.


¹http://www.thirteen.org/moyers/trading_democracy/sample.html.

² CCPA Monitor, November 1998.

Robert Chernomas is professor of economics at the University of Manitoba. He has published in both the academic and popular literature in the areas of macroeconomics, history of economic thought, health care economics, post-secondary education and social economic determinants of health. He has lectured in Canada, the United States, China, Africa and Europe. He is a former co-chair of the Alternative Federal Budget and is currently a board member of the Council of Canadians.

The views expressed are those of the author and not necessarily those of CAUT.