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Mindfully.org note: On one hand the industry claims these crops are unique for the purposes of patenting. And on the other hand they claim them to be the same for regulatory purposes. The industry falls one personality short of the Three Faces of Eve (1957), the movie about a woman with multiple personality disorder.
In spite of
Miller's insistence that there is too much regulation, the FDA provides only lip service to enforcement.
The regulations that are actually enforced amount to little more than words on paper.
The industry is essentially
self-regulating in the same way that an alcoholic or smoker self-regulates.
As a Fellow at the Hoover Institute — an ultraconservative think tank — Miller has focused much of his attention on biotechnology. Herbert Hoover, the 31st president of the United States(1929-1933), founded the Institute at Stanford. After the stock market crash on Black Tuesday, October 29, 1929 Hoover was unwilling to finance employment through federal intervention. A month after the crash, Hoover said, “Any lack of confidence in the economic future or the basic strength of business in the United States is foolish.” This line of thinking is the model for our present administration. Books by Miller:
Americans are indeed dying for regulatory reform. It is the kind that creates meaningful regulations that are actually enforced rather than ignored. Our regulatory reform would also end campaign financing and the FDA's strong ties to industry. Ann Veneman, USDA Secretary had been a lawyer-lobbyist for food companies. More. . . We are a nation that expects to take a pill in order to continue the eating binge. This model is reflected in all areas of the American Way. Whether in the US or abroad, we exhibit a tendency towards excess that is immediately recognizable. We eat too much and exercise too little; borrow too much and save too little; and we drive gas-guzzling SUVs that are unsafe at almost any speed. We pride ourselves as a nation on our mindless consumption fueled by a pervasive national arrogance, which is outdone only by our ignorance. |
The FDA is the nation's most ubiquitous regulatory agency. It oversees products that account for 25 cents of every consumer dollar, with a value of over a trillion dollars annually — and it's in turmoil.
First the agency was blindsided by Chiron Corporation's inability to provide flu vaccine this season due to contamination at its manufacturing facility, depriving Americans of half the usual supply. Then came Merck's withdrawal from the market of its blockbuster anti-inflammatory drug, Vioxx, because of cardiovascular and cerebrovascular side effects. This led one of FDA's medical officers, in congressional testimony last week, to accuse his own colleagues of discounting recommendations from the agency's safety researchers, and of consistently being in denial when data indicates safety problems from an approved drug.
The FDA is a favorite target of critics, who variously accuse regulators of excessive risk-aversion and delay of approvals, or of too cozy a relationship with the drug industry. Former FDA Commissioner Frank E. Young once characterized his agency as "a slow-moving target that bleeds profusely when hit."
Sen. Charles E. Grassley, chairman of the Senate Finance Committee, which held hearings last week, chided the agency, "The health and safety of the public must be the FDA's first and only concern." He is right, but particularly when governmental pre-marketing approval of a product is required, greater safety is not synonymous with more stringent regulation. In fact, net benefit to patients often suffers because of an obscure regulatory anomaly: the asymmetry of outcomes from the two types of mistakes that regulators can make. A regulator can commit an error by permitting something bad to happen (approving a harmful product), or by preventing something good from becoming available (not approving a beneficial product). Both outcomes are bad for the public, but the consequences for the regulator are very different.
The first kind of error is highly visible, causing the regulators to be attacked by the media and patient groups, and to be investigated by Congress. But the second kind of error — keeping a potentially important product out of consumers' hands — is usually a non-event, eliciting little attention, let alone outrage. Former FDA Commissioner Alexander Schmidt aptly summarized the regulator's conundrum: "In all our FDA history, we are unable to find a single instance where a Congressional committee investigated the failure of FDA to approve a new drug. But the times when hearings have been held to criticize our approval of a new drug have been so frequent that we have not been able to count them. The message to FDA staff could not be clearer."
As a result, regulators make decisions defensively, so they tend to delay or reject new products of all sorts, from fat substitutes to vaccines and painkillers. That's bad for public health and for consumers' freedom to choose. Congressional oversight is supposed to provide a check on regulators' performance, but rarely does it focus on their unnecessarily delaying product approvals. After all, a premature or mistaken approval makes for more exciting hearings, with injured patients and their families paraded before the cameras. Even when regulators' inappropriate delays are exposed, they can fall back on the "erring on the side of caution, better safe than sorry" defense. Too often, legislators, the media, and the public accept these euphemisms uncritically, making our system of pharmaceutical oversight progressively less accountable and less relevant to the public interest.
If we are to balance drug safety, innovation in R&D, and the availability and price of new medicines, we must find a way to make regulators accountable for costly errors of all kinds. One way would be to create a vigorous, independent agency ombudsman that could compel regulators to act in the public interest. The office would have to possess the following attributes: (1) independence from the agency and the FDA commissioner; (2) access to independent expertise in relevant disciplines, including medicine, pharmacology, science, regulation, and law; and (3) the power to levy sanctions against FDA employees found to be responsible, individually or collectively, for flawed decisions or policies that constitute severe, avoidable errors.
Americans are, literally, dying for regulatory reform. It's past time they got it.
Mr. Miller, a fellow at the Hoover Institution and the Competitive Enterprise Institute, and author of "The Frankenfood Myth" (Praeger, 2004), was an FDA official from 1979-94.
Page A8
Press Release
FOR IMMEDIATE RELEASE.
September 20, 2004
The Frankenfood Myth: How Protest and Politics Threaten the Biotech Revolution
By Henry I. Miller and Gregory Conko
STANFORD—Few topics have inspired as much international furor and misinformation as the development and distribution of genetically altered foods. For thousands of years, farmers have bred crops for their resistance to disease, productivity, and nutritional value; and over the past century, scientists have used increasingly more sophisticated methods for modifying them at the genetic level. But only since the 1970s have advances in biotechnology (or gene-splicing to be more precise) upped the ante, with the promise of dramatically improved agricultural products—and public resistance far out of synch with the potential risks.
In The Frankenfood Myth: How Protest and Politics Threaten the Biotech Revolution, Hoover research fellow Henry Miller and Gregory Conko trace the origins of gene-splicing, its applications, and the backlash from consumer groups and government agencies against so-called "Frankenfoods"—from America to Zimbabwe.
They explain how a "happy conspiracy" of anti-technology activism, bureaucratic over-reach, and business lobbying has resulted in a regulatory framework in which there is an inverse relationship between the degree of product risk and degree of regulatory scrutiny. The net result, they argue, is a combination of public confusion, political manipulation, ill-conceived regulation (from such agencies as the USDA, EPA, and FDA), and ultimately, the obstruction of one of the safest and most promising technologies ever developed—with profoundly negative consequences for the environment and starving people around the world.
The authors suggest a way to emerge from this morass, proposing a variety of business and policy reforms that can unlock the potential of this cutting-edge science, while ensuring appropriate safeguards and moving environmentally friendly products into the hands of farmers and consumers. This book is guaranteed to fuel the ongoing debate over the future of biotech and its cultural, economic, and political implications.
The Frankenfood Myth
How Protest and Politics Threaten the Biotech Revolution
By Henry I. Miller and Gregory Conko
ISBN: 0-275-97879-6 $39.95
296 pages September 2004
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