Biotech Sanity in California

We are pleased when we are able to post the insights of Dr. Henry Miller, physician, molecular biologist, and fellow at the Hoover Institution and author of "The Frankenfood Myth." Dr. Miller headed the FDA's office of biotechnology from 1989 to 1993.   In this post, Dr. Miller describes recent proposed legislative action in California that would give genetically enhanced plant products and technologies a level playing field upon which to articulate their virtues. 

Dr. Miller's complete editorial follows.

Anatole France famously said, "If 50 million people say a foolish thing, it is still a foolish thing." That aphorism applies to politicians and voters who have, over the last few years, introduced and passed local ordinances in four California counties to ban the cultivation of plants improved with state-of-the-art genetic techniques. These actions in Trinity, Mendocino, Marin, and Santa Cruz counties represent democracy at its worst.

To begin with, the measures are unscientific and logically inconsistent, in that their restrictions are inversely related to risk:  They permit the use of microorganisms and plants that are crafted with less precise and predictable techniques but ban those made with more precise and predictable ones.

Further, vast numbers of gene-spliced and other bacteria are released routinely from ordinary, low-contaminant microbiology laboratories, such as those at UC Santa Cruz, without any harmful effects. A study by the Environmental Protection Agency found that for each technician in such labs, 50 million to one billion bacteria on average escape daily on lab coats, in hair, or just blowing out the door.

But there is a far more fundamental issue at stake:  The freedom of individuals and companies to pursue lawful activities unencumbered. All citizens should be concerned about the implications of subjecting safe, legitimate commercial products, in this case plants crafted with a proven, superior technology to surveillance, confiscation and destruction by local officials.

Fortunately, California legislators have introduced a bill, SB 1056, that would preempt local regulation of seeds and nursery stocks. It would ensure consistency of regulation throughout the state and obviate the need for farmers to navigate a county-by-county patchwork of restrictions and requirements. The bill has the support of virtually all major agricultural organizations, including the California Farm Bureau, Western United Dairymen, Western Growers Assn., the Wine Institute and more.

Outlawing the cultivation of insect-resistant crops developed with the assistance of modern biotechnology ensures the increased use of chemical persticides, the persistence of these chemicals in ground and surface water, and it will result in increased occupational exposures.

Most important, the county prohibitions block sophisticated genetic approaches to the eradication of blights that threaten a variety of crops and ornamental plants in California. Biotechnology's potential is not just theoretical. By inserting a single gene into squash and other crops, scientists have made them virus-resistant. Gene-spliced papaya varieties have resurrected Hawaii's $64 million-a-year industry, which was moribund a decade ago because of the predations of ringspot virus. And because gene splicing has enhanced the resistance of plants to pests and disease, we have been spared the use of millions of pounds of chemical pesticides.

The future holds out even greater hope. The technology makes it possible to remove dangerous allergens from wheat, peanuts, milk, and other commonly allergenic foods. Gene splicing will allow crop varieties to thrive in conditions of drought or near-drought.

For years, activists have relentlessly promoted the Big Lie about gene splicing; namely, that it is unproven, unwanted, untested, and unregulated. After more than 20 years, none of the hypothetical concerns about safety has been substantiated. Crops using gene-splicing techniques are grown by 8.5 million farmers in 21 countries annually. California farmers plant almost a million acres of gene-spliced crops annually. Americans have consumed more than a trillion servings of foods that contain gene-spliced ingredients.

There is not a single documented case of injury to a person or disruption of an ecosystem. There is a broad consensus among scientists that gene-splicing techniques are essentially an extension, or refinement, of earlier ones, and that gene transfer or modification by molecular techniques does not, per se, confer risk.

Letting ideology and misguided activism trample science and common sense is antithetical to sound public policy. That's why we need SB 1056.

Expert Witness Court Test in Ohio

The Ohio Supreme Court recently issued a 4-3 decision that affirmed lower court rulings that held that rules of evidence governing "expert witnesses" can preclude testimony about an alleged cancer resulting from chemical exposures where no studies are cited to demonstrate a causal effect between the exposure and the cancer.

In the case at hand, the family of an employee at PPG Industries alleged that workplace exposure to chemicals for some 30 years was responsible for a very rare form of brain cancer. At trial in county court, the family's attorney presented testimony from doctors and an industrial hygienist. That testimony suggested some undefined relationship between the employee's work and the cancer he developed. However, the county court rejected the testimony as not meeting the standards for expert witnesses - and issued a summary judgment in favor of PPG.

A majority court  opinion stated that "Expert opinion based on unscientific principles and methodology is unhelpful to the trier of fact and has no place in courts of law," and that none of the so-called expert witnesses in the case at hand cited any scientific studies that provided evidence of a causal connection between the employee's work at PPG and the brain cancer.

This decision was cited as support for the principle that "expert" testimony must meet standards of scientific validity and quality, and that PPG was to be commended for defending the principle of good science in the courtroom.

Politicization of Science

Dr. Henry Miller, physician and Fellow at the Hoover Institution, recently wrote an Opinion for the San Diego Union-Tribune (March 10, 2006) on the Politicization of Science.  For the public "consumer," this translates into situations where government officials can be in a position to extend unmerited bias to either the expediting or delaying of development of products and treatments relating to human health.   The entire article has been included in this forum.

Politicization of Science is Bipartisan,  by Dr. Henry Miller (to the San Diego Post)

Angered by the Food and Drug Administration's repeated delays in approving over-the-counter distribution of the morning-after contraceptive Plan B, Susan Wood quit six months ago as the agency's assistant commissioner of women's health. Instead of rolling over and "going along to get along" - the bureaucrat's credo - Wood voted with her feet.

Since her resignation, Wood has been writing articles and giving lectures in which she laments that "our federal health agencies seem increasingly unable to operate independently and that this lack of independence compromises their mission of promoting public health and welfare," as she wrote in a recent op-ed.

However, Wood also mentioned that she is a 15 year veteran of the federal government, which makes one wonder where she spent the 1990s. Although there is no question that many of the Bush administration's science-related appointments and its record leave much to be desired - witness the litmus tests for appointees to science-related positions, distortion of information to consumers about health and safety issues, undisguised antagonism toward embryonic stem cell research, and the FDA's appparently politically motivated decision on over-the-counter sales of Plan B - the Clinton administration's blatant perversion of science was even more pervasive and egregious.

As Clinton's science and technology czar, Al Gore was entrusted with choosing many top appointees to regulatory agencies, thereby obtaining the leverage to politicize the administration's policies and decisions. There was no room for dissention or respect for data-driven policy in the Clinton administration, no participation in the marketplace of ideas unless you were a true believer and willing to toe the party line. And on many environmental and public health issues, it was a very radical party line, indeed.

As to more direct politicization of decision-making during the Clinton-Gore years, I was a senior FDA official during most of the first term, and, like many of my colleagues, was appalled at the willingness of then-FDA Commissioner David Kessler to take orders from above about which products should be expedited and which should be delayed by regulators. For example, the agency approved a dubious female condom after being informed by the secretary of Health and Human Services that it was a "feminist product" and that delay was not acceptable; and FDA officials went to [extraordinary] lengths to look for reasons to deny approval to biotech-derived bovine somatotropin, a veterinary drug, because the vice-president's office considered it to be politically incorrect.

Never has American government been burdened with such politically motivated, anti-science, anti-business, anti-social eco-babble as duiring the Clinton-Gore years, but during that time I don't recall hearing from the born-again, now-vociferous defenders of scientific, data-driven public policy.

Lamentably, both Democrats and Republicans have learned to excel at the Emperor's New Clothes School of policy-making. By moving from step to bureaucratic step according to the rules, with everyone pretending that the evolution and substance of the policy are plausible, the pols and bureaucrats can confer legitimacy on almost any policy, no matter how flawed, unscientific, or inimical to the public interest. There is an axiom in the nation's capital that something said three times becomes a fact; and adherence to the procedural requirements of federal rule making is the apotheosis of that idea.

As Massachusetts Institute of Technology meterologist Richard Lindzen has sagely observed, science "provides our only way of separating what is true from what is asserted. If we abuse that tool, it will not be available when it is needed." Cynicism about the motivations and actions of those in government is healthy.  But if criticism about abuses of science - among other things - is to be credible, it should be consistent and evenhanded, even if not wholly apolitical.

Perchlorate Standard in Massachusetts

The nation's first drinking water standard for perchlorate has been proposed by the state of Massachusetts at a level of 2 ppb, an order of magnitude lower than the EPA's current "reference dose" (recommended safe limit).  The state claims that the proposal reflects growing scientific evidence of exposure to perchlorate from various pathways other than water. The article did not mention the growing evidence that perchlorate occurs naturally as a result of energetic atmospheric chemistries.

Separately, an EPA advisory committee on children's health has submitted a letter to EPA Administrator Stephen Johnson urging the agency to set a federal water standard for perchlorate and/or to issue a health advisory for drinking water that will specifically protect infants. At issue with the current clean-up goal of 24.5 ppb for Superfund toxic waste sites, the committee cites factors such as infants' extra fluid needs and lighter weights as factors in their opinion. Various toxicological experts have gone on record as saying that long-term exposure to perchlorate at levels as high as 200 ppb are generally expected to be safe, and included sensitive sub-populations such as nursing infants and fetuses.

An article reflecting this news and its attendand political controversy was published in the March 15, 2006 issue of the Wall Street Journal.

Risk Assessment and the FDA

The March 1, 2006 issue of Genetic Engineering News features a column by Shep Bentley under the heading of FDA News & Analysis titled:  Finding a Balance in Assessment of Risk. The essential question impacting the drug industry is who should decide when a product is unsafe, and by what standards ?  The most critical problem appears to be the absence of  any remotely standardized expression of benefit within the paradigm of risk/benefit analysis. Value ascribed to  a drug or a process may be vaguely inferred, but rarely clearly stated and quantified.

This "biomedical" analysis differs from risk assessment involving toxicological and analytical chemistries, although both are forced to address inherent uncertainties. In the latter, the ever lower threshold of instrumental detection limits has often left uncertainty factors to the imagination (and potential manipulation) of the beholder.  In the medical realm, the "First Do No Harm" principle runs the risk of being extrapolated into a precautionary principle that may  preclude the accommodation of reasonable (calculated) risk.

Probably under-appreciated is the reality that the common denominator for evaluating risk is society's values. A pain-averse society uses a quality of life measurement that teeters on a delicate balance of function and comfort. Pre-market drug submission that includes less risk-related data and more quantitative expression of product benefit would be the new paradigm. But the fact is that although risk mitigation is a zero-sum exercise, there is always some residual risk.

More information can be found at www.genengnews.com.

Slippery Teflon Charges Won't Stick

By Gregory Conko and Henry I. Miller

The uncanny ability of President Ronald Reagan to deflect public criticism won him the nickname, "The Teflon President." Ironically, now it is Teflon itself that is facing the heat, as anti-chemical groups and trial attorneys have joined forces to cook up controversy over a product that has become one of America's most trusted consumer icons, as well as an integral part of our language, like Thermos and Kleenex.

The radical Environmental Working Group has charged that the billions of meals worldwide prepared every day on Teflon cookware are being contaminated with "Teflon toxins," and two Florida-based law firms have filed a $5 billion class-action suit in eight states against the manufacturer, DuPont, for "failing" to warn consumers about the product's alleged dangers.

But, like many product-safety scares these days, these charges are bogus. And that really fries us.

The truth is that an EPA advisory panel has recommended more testing of a chemical known as PFOA, which is used to make non-stick coatings and numerous other products, including those trademarked as Teflon. However, both Teflon and PFOA have been the subject of numerous studies, and there is not a shred of evidence that either poses a human health risk.

Only when tested at very high doses on mice and rats, has PFOA been shown to cause cancer, but under the EPA's current policy, such questionable animal data are enough to classify the chemical as a "likely human carcinogen." That high-dose test methodology is unreliable, though, because it is totally irrelevant to real world exposures. In fact, a wide spectrum of naturally occurring chemicals -- including many that are common constituents of our diet -- also cause cancer in lab animals at high doses. At the very low doses to which humans are actually exposed, most natural and synthetic chemicals are completely harmless.

Most compelling of all, PFOA is not present in the actual non-stick cookware coating -- including pots and pans coated with Teflon. A recent peer-reviewed published study confirmed that there is no detectable consumer exposure to PFOA through Teflon-coated cookware. Even the chronically over-cautious European Food Safety Administration recently dismissed the trumped up concerns and allowed the continued use of non-stick coatings in cookware. Studies in Denmark and China also have also confirmed Teflon's safety.

Finally, the risk-averse U.S. EPA has stated quite clearly that it "does not believe there is any reason for consumers to stop using any consumer or industrial related products" as a result of their ongoing investigation into PFOA.

That should be the end of the story. But the persuasive evidence against any injury caused by Teflon doesn't faze attorney Alan Kluger. "I don't have to prove that it causes cancer," he said. "I only have to prove that DuPont lied in a massive attempt to continue selling their product."

What's going on here?

The typical formula used in these big class action suits is to trump up some bogus health claim, demand a quick settlement, and then cut and run before the facts are weighed in litigation. The lawyers know they can count on people's fear of chemicals and their natural concern for the health of their families to generate public outrage. Teflon has been around for half a century and is ubiquitous.

As toxicologist and president of the American Council on Science and Health Dr. Elizabeth Whelan has pointed out, "Teflon, probably more than any industrial product, is the poster child of modern technology, one that has made our lives easier and more enjoyable." It is precisely the product's "stellar success story [that] makes it a very ripe target for those who spew chemical-phobia in their crusade to eliminate the tools modern industrial chemistry has given us -- pesticides, pharmaceuticals, food additives, and more."

Another factor in pursuing bogus claims is that the plaintiffs' lawyers know they can often count on a major corporation like DuPont to capitulate in order to protect its reputation. In 2004, for example, the company paid an $82 million out-of-court settlement to the residents of Parkersburg, West Virginia, who alleged that PFOA from a nearby DuPont plant had tainted their water supplies -- in spite of the lack of any supportive evidence. In fact, a University of Pennsylvania study examined neighbors of the Parkersburg claimants who used the same water source and found no harmful effects.

We hope that this time DuPont fights to the bitter end to expose this class action charade.

Lamentably, whether litigation is involved or not, activists commonly misrepresent environmental or public health risks. Undeterred by the facts, many self-styled public health advocacy organizations like the Environmental Working Group, Greenpeace, Center for Science in the Public Interest, and the Union of Concerned Scientists know that to have an impact, their charges need not be true but merely plausible. The media -- whose motto is "if it bleeds, it leads" -- does the rest: "Are you eating cancer-causing chemicals in every meal? Details at 11!"

Also, it's hard for the public to shed a tear for the misfortunes of a corporate goliath like DuPont, the creator of the Teflon miracle and the owner of the trademark. The days of "Better Things for Better Living through Chemistry" -- DuPont's advertising slogan until 1981 -- are long gone, as chemicals are now looked upon with suspicion by many people. Moreover, big multinational companies of any kind are largely unappreciated, no matter how many jobs they create or lives they enrich.

Distortion and manipulation of science by self-styled consumer groups in pursuit of political agendas and by voracious plaintiffs' attorneys looking for the next big score erodes our society's capacity to innovate and prosper. It jeopardizes safe and beneficial products and harms manufacturers and their employees. In the absence of persuasive evidence vetted by experts, consumers should reject the attacks on Teflon, as well as on other essential products like vaccines, pesticides, medical drugs, and many others. The charges just won't stick.

Gregory Conko is a senior fellow at the Competitive Enterprise Institute. Henry I. Miller, a physician and fellow at the Hoover Institution, was an FDA official from 1979-1994. Barron's selected their book, "The Frankenfood Myth," as one of the 25 Best Books of 2004.

Medical Monitoring Claims

The August 9-15, 2004 issue of the Chemical Market Reporter published a report of court action in Michigan pertaining to speculative medical monitoring claims.  At issue is the present liability to be associated with the potential development of a medical condition, and medical monitoring related thereto.

The American Chemistry Council (ACC) is urging the Michigan Supreme Court to reject claims for ongoing medical monitoring by plaintiffs who are not injured.

In a brief filed last week, the ACC urged the court to overturn a lower court's order allowing medical monitoring in the case of Henry v. Dow Chemical Company.  The brief argues that the lower court order, if allowed to stand, would have a significant adverse effect on plaintiffs who have suffered an injury, the state court system, and the business community.

The issue presented in this case is whether the State of Michigan permits individuals who have been exposed to a potentially hazardous substance, but who are not actually injured, to bring a lawsuit for "medical monitoring."

Unlike traditional lawsuits, such claims would not require any showing of a present, physical injury. Instead, plaintiffs could obtain monetary awards based on a speculative potential of the plaintiff developing a medical condition in the future.

Despite two separate decisions by the Supreme Court of Michigan in 1993 and 1998 rejecting such claims, lower courts have at times wither ignored those decisions or taken advantage of perceived ambiguity in the language to allow medical monitoring claims to move forward.

The brief notes that in the few jurisdictions that permit medical monitoring claims, such as West Virginia, entrepreneurial plaintiffs' lawyers have brought lawsuits on behalf of thousands of healthy individuals. It says one West Virginia Supreme Court Justice has stated that the practical effect "is to make almost every [resident] a potential plaintiff in medical monitoring cause of action."

If the Supreme Court of Michigan does not take action, the brief cautions, "Michigan courts could become clogged with speculative medical monitoring claims." As a result, "access to justice for those with present, serious, physical injuries may be delayed or denied."