WASHINGTON _ Here's a test to see how closely you've beenreading the op - ed pages lately. Jeremy Rifkin is to thebiotechnology industry as Henry Miller is to: (a) the FDA, (b) theU.S. Department of Agriculture (USDA), (c) the EnvironmentalProtection Agency, (d) the Clinton administration's biotechnologypolicies or (e) all of the above.
If (e) was your answer, you've clearly been reading the editorialpages of The Wall Street Journal, The Washington Times, TheChicago Tribune, The San Jose Mercury News, and The San DiegoUnion Tribune, to name just a few. In a blitzkrieg of editorials,Miller has relentlessly criticized the policies of all the majorgovernment agencies that regulate biotechnology. Excessivegovernment regulation is killing innovation and damaging theindustry, he has argued. His views are showing up in peer-reviewedscientific journals. And a Miller analysis of EPA policies will soonbe published in Science.
Rifkin, an anti-biotech activist who heads the Washington-basedFoundation for Economic Trends, and Miller approachbiotechnology from the poles of public policy debate. But somecritics say that while Rifkin is a demagogue, Miller can be ascientific, anti-regulatory zealot who is out of touch with politicalrealities and public sentiment. What sets Miller apart and makes hisviews even more provocative are his regulatory credentials.
Miller, currently a fellow of scientific philosophy and public policyat Stanford University's Hoover Institution, worked at the FDA from1979 to 1993. He started his career at the agency as a medicalreviewer, working on the approvals of the first two recombinantDNA products _ recombinant human insulin and human growthhormone. "We approved Humulin [recombinant human insulin] infive months and human growth hormone in 11 months at a timewhen 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 Millerbecoming founding director of the FDA's Office for BiotechnologyPolicy. According to Miller, FDA commissioner David Kessler"dismantled" the office "on the advice of the Clintonadministration." As a result, Miller has moved his base of operations,at least temporarily, to academia. (He still has an option to return tothe FDA).
Miller: Ideological Foes Are `Troglodytes'
Miller is not one to mince words, a trait which has "really rubbedpeople the wrong way," one of his fans conceded on condition ofanonymity. For example, he routinely dismisses ideological foes as"troglodytes." A headline for one of Miller's recent editorials, "TheWhite House biotech Luddites," is typical of one of his main themes.Miller says he believes that the Clinton administration has spewedpro-technology, pro-science rhetoric in an attempt to portray itself asa friend to the biotechnology industry while its policies have causedirreparable 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 wrotein The Washington Times in October. He went on to criticize theUSDA for requiring "unnecessary permits" for more than 1,400 fieldtrials of genetically modified plants and to chastise the FDA fordeveloping a pre-market notification policy for foods manufacturedwith recombinant DNA techniques.
Miller reserves his most biting disdain for the EPA, which recentlypublished plans to regulate genetically engineered microbes andpest-resistant plants. "The EPA's biotechnology regulatory policiesare the most egregious of all," he wrote recently. "EPA targets onlyproducts made with the most precise and predictable new geneticmethodologies."
An EPA official who asked not to be identified described Miller as"a thorn in our side." "Henry has made a career of criticizing usbecause he hates anyone who tries to regulate genetically engineeredmaterials," said the source. "The problem is now he's got time topublish extensively."
Miller says that regulation and pre-market review should be basedsolely on the safety of products rather than on the technologicalmethods (such as recombinant DNA techniques) that are used tocreate them. He champions this "risk-based" regulatory policyapproach over "technique-based" approaches. While most scientistsagree that risk-based policies are the most rational, consumeradvocates have argued that the public has a right to know whattechniques were used.
Kessler himself disagrees with a strictly risk-based regulatoryscheme. "While study of the final product ultimately holds theanswer to whether or not it is safe, knowing the process used tocreate it helps in understanding what questions to ask," he said in a1993 speech on bioengineered foods. "Proponents of geneticengineering have heralded the wonders of food biotechnology, whileat the same time arguing that it is nothing new. They have sought thepublic's trust, yet have not sought the oversight and openness thatbuilds that trust."
A Master Of Regulatory Sciences
Miller is highly regarded for his grasp of scientific and regulatoryissues by those in industry. "Intellectually, there is no one whounderstands 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 AlGore, said that Miller has promoted and prolonged industry-government conflicts rather than helped solve them.
"He has prevented regulatory certainty rather than created it byconsistently obstructing compromise," Simon told BioWorld. "Thebiotechnology industry has suffered more from Henry Miller thanfrom EPA policies because he has continued to fight on issues longafter industry wanted to reach a solution. Industry's bottom line ispractical _ 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 concernsabout biotechnology and the safety of their foods and drugs. He saidthat Miller's position boils down to the idea that as long as scientistsfeel their work is safe, it's safe. And that's out of sync with a host offederal laws governing pesticides and foods, said Simon.
"You find me one single Republican congressman who wants to gohome and tell his or her constituents that genetically engineeredorganisms are being released in fields all over his or her districtwithout any government reviews," said Simon. "The Americanpublic isn't interested in having private companies determine thesafety of foods, drugs and pesticides."
Gore and his advisors have been one of Miller's prime targets. In onerecent editorial, Miller suggested that Gore be removed from anyinvolvement with regulatory policy and that his regulatory advisorsbe dismissed. Miller told BioWorld that he is hopeful the Republicansweep of the House and Senate will force the Clinton administrationto be "more rational, market-oriented and risk-based" in its approachto biotechnology. "Perhaps this new Congress will conductinvestigative hearings that haul in regulators and administrationofficials to explain their policies and the direct and indirect coststhey impose," he said.
Industry insiders told BioWorld that Miller raises critical issuesabout government and regulation and thus plays an important role asagitator, but that his views don't allow room for compromises."Miller is a purist and we agree with his scientific arguments," saidSimon Best, chairman of the Biotechnology Industry Organization'sfood and agriculture division. "But sometimes political compromisesare necessary. That's the world we live in. The most powerful thingwe can do right now to allay consumers' fears is to get good biotechproducts on the market. We can do that within the existing regulatoryframework.
"There's no harm in having polarized views vigorously expressed,"continued Best. "But a democratic process means that views on bothsides of an issue must be taken into account." n
-- Lisa Piercey Washington Editor
(c) 1997 American Health Consultants. All rights reserved.