WASHINGTON _ Here's a test to see how closely you've been reading the op - ed pages lately. Jeremy Rifkin is to the biotechnology industry as Henry Miller is to: (a) the FDA, (b) the U.S. Department of Agriculture (USDA), (c) the Environmental Protection Agency, (d) the Clinton administration's biotechnology policies or (e) all of the above.
If (e) was your answer, you've clearly been reading the editorial pages of The Wall Street Journal, The Washington Times, The Chicago Tribune, The San Jose Mercury News, and The San Diego Union Tribune, to name just a few. In a blitzkrieg of editorials, Miller has relentlessly criticized the policies of all the major government agencies that regulate biotechnology. Excessive government regulation is killing innovation and damaging the industry, he has argued. His views are showing up in peer-reviewed scientific journals. And a Miller analysis of EPA policies will soon be published in Science.
Rifkin, an anti-biotech activist who heads the Washington-based Foundation for Economic Trends, and Miller approach biotechnology from the poles of public policy debate. But some critics say that while Rifkin is a demagogue, Miller can be a scientific, anti-regulatory zealot who is out of touch with political realities and public sentiment. What sets Miller apart and makes his views even more provocative are his regulatory credentials.
Miller, currently a fellow of scientific philosophy and public policy at Stanford University's Hoover Institution, worked at the FDA from 1979 to 1993. He started his career at the agency as a medical reviewer, working on the approvals of the first two recombinant DNA products _ recombinant human insulin and human growth hormone. "We approved Humulin [recombinant human insulin] in five months and human growth hormone in 11 months at a time when the average drug approval took 30 months," said Miller.
In 1983, Miller became a special assistant to then- commissioner Frank Young, a job which led in 1989 to Miller becoming founding director of the FDA's Office for Biotechnology Policy. According to Miller, FDA commissioner David Kessler "dismantled" the office "on the advice of the Clinton administration." As a result, Miller has moved his base of operations, at least temporarily, to academia. (He still has an option to return to the FDA).
Miller: Ideological Foes Are `Troglodytes'
Miller is not one to mince words, a trait which has "really rubbed people the wrong way," one of his fans conceded on condition of anonymity. For example, he routinely dismisses ideological foes as "troglodytes." A headline for one of Miller's recent editorials, "The White House biotech Luddites," is typical of one of his main themes. Miller says he believes that the Clinton administration has spewed pro-technology, pro-science rhetoric in an attempt to portray itself as a friend to the biotechnology industry while its policies have caused irreparable harm.
"Biotechnology regulation, the bete noire of the [Clinton] administration's policies, has become increasingly anti-innovative, unscientific and focused on negligible-risk activities," Miller wrote in The Washington Times in October. He went on to criticize the USDA for requiring "unnecessary permits" for more than 1,400 field trials of genetically modified plants and to chastise the FDA for developing a pre-market notification policy for foods manufactured with recombinant DNA techniques.
Miller reserves his most biting disdain for the EPA, which recently published plans to regulate genetically engineered microbes and pest-resistant plants. "The EPA's biotechnology regulatory policies are the most egregious of all," he wrote recently. "EPA targets only products made with the most precise and predictable new genetic methodologies."
An EPA official who asked not to be identified described Miller as "a thorn in our side." "Henry has made a career of criticizing us because he hates anyone who tries to regulate genetically engineered materials," said the source. "The problem is now he's got time to publish extensively."
Miller says that regulation and pre-market review should be based solely on the safety of products rather than on the technological methods (such as recombinant DNA techniques) that are used to create them. He champions this "risk-based" regulatory policy approach over "technique-based" approaches. While most scientists agree that risk-based policies are the most rational, consumer advocates have argued that the public has a right to know what techniques were used.
Kessler himself disagrees with a strictly risk-based regulatory scheme. "While study of the final product ultimately holds the answer to whether or not it is safe, knowing the process used to create it helps in understanding what questions to ask," he said in a 1993 speech on bioengineered foods. "Proponents of genetic engineering have heralded the wonders of food biotechnology, while at the same time arguing that it is nothing new. They have sought the public's trust, yet have not sought the oversight and openness that builds that trust."
A Master Of Regulatory Sciences
Miller is highly regarded for his grasp of scientific and regulatory issues by those in industry. "Intellectually, there is no one who understands regulatory science better than Henry," Joe Panetta, director of regulatory affairs for San-Diego-based Mycogen Corp., told BioWorld. But government officials are critical of his approach. Greg Simon, chief domestic policy advisor to Vice President Al Gore, said that Miller has promoted and prolonged industry- government conflicts rather than helped solve them.
"He has prevented regulatory certainty rather than created it by consistently obstructing compromise," Simon told BioWorld. "The biotechnology industry has suffered more from Henry Miller than from EPA policies because he has continued to fight on issues long after industry wanted to reach a solution. Industry's bottom line is practical _ selling products. Henry's bottom line is theological _ he takes a religious approach to these issues."
Simon said that Miller is out of touch with the public's concerns about biotechnology and the safety of their foods and drugs. He said that Miller's position boils down to the idea that as long as scientists feel their work is safe, it's safe. And that's out of sync with a host of federal laws governing pesticides and foods, said Simon.
"You find me one single Republican congressman who wants to go home and tell his or her constituents that genetically engineered organisms are being released in fields all over his or her district without any government reviews," said Simon. "The American public isn't interested in having private companies determine the safety of foods, drugs and pesticides."
Gore and his advisors have been one of Miller's prime targets. In one recent editorial, Miller suggested that Gore be removed from any involvement with regulatory policy and that his regulatory advisors be dismissed. Miller told BioWorld that he is hopeful the Republican sweep of the House and Senate will force the Clinton administration to be "more rational, market-oriented and risk-based" in its approach to biotechnology. "Perhaps this new Congress will conduct investigative hearings that haul in regulators and administration officials to explain their policies and the direct and indirect costs they impose," he said.
Industry insiders told BioWorld that Miller raises critical issues about government and regulation and thus plays an important role as agitator, but that his views don't allow room for compromises. "Miller is a purist and we agree with his scientific arguments," said Simon Best, chairman of the Biotechnology Industry Organization's food and agriculture division. "But sometimes political compromises are necessary. That's the world we live in. The most powerful thing we can do right now to allay consumers' fears is to get good biotech products on the market. We can do that within the existing regulatory framework.
"There's no harm in having polarized views vigorously expressed," continued Best. "But a democratic process means that views on both sides of an issue must be taken into account." n
-- Lisa Piercey Washington Editor
(c) 1997 American Health Consultants. All rights reserved.