TCS Daily


Women Beware

By Melana Zyla Vickers - July 24, 2002 12:00 AM

Editor's note: The Environmental Working Group and other such activists must be feeling pretty smug this week, as regulators from the Food and Drug Administration sit cooped up in a suburban Maryland hotel reviewing, for three days, their own brand new advice on how much fish should be consumed by pregnant women, given that the women risk exposing their babies to mercury contamination.

The review is a direct result of pressure from the activists, who have argued the FDA advice on fish is not alarmist enough. The trouble, though, is the activists' criticism has almost no basis in science. Yet it's typical of the kind of attack that gets the FDA's attention, and causes the regulators to backpedal.

If the FDA at the end of its meeting on Thursday decides to tighten its mercury/fish standards, the activists will have won a victory. The public, meanwhile, will be left confused, because the standards were only just set 19 months ago. To read more about the unreasonable influence activist groups have on the FDA, turn to the paper enclosed below, by TCS columnist and Independent Women's Forum senior fellow Melana Zyla Vickers.

American women enjoy excellent healthcare, and in the last two decades have benefited from advances in nutrition, drugs, and other medical treatment that have combated diseases, improved quality of life, and extended longevity by an average of five years. American women could be enjoying even better healthcare, though, if the federal Food and Drug Administration weren't regularly hijacked by activist groups that misrepresent health risks, unnecessarily frighten the public, and pressure the agency to slow down, and occasionally stop, medical advances.

The most familiar such example has been the exaggerated scare over silicone breast implants: Despite several independent medical studies failing to find causality between silicone breast implants and auto-immune disease, activist groups and trial lawyers succeeded in pressuring the FDA to impose a moratorium on the implants in 1992.

Plenty of more recent examples exist. Consider the women's health scares that the FDA has had to react to in the last two years: The government conspires to allow fatally high mercury levels in fish; stomach-discomfort and weight-reduction drugs are deadly; newly approved drugs are deadly; and nail polish is harmful to women's health. These scares have led to FDA reconsiderations of policy, channeling of taxpayer resources toward the scare and away from other productive uses, and contributed to an overall slowing of the regulatory process.

Yet the FDA response to the scares has much more to do with politics than science: Each scare generates mainstream-media coverage, often on the front page of newspapers. Each scare proves to have an avowedly anti-corporate group such as Public Citizen or the Environmental Working Group as its instigator. And each scare is based on a mis-assessment of risk that plays to women's fears rather than to women's sense of reason. Put another way, the FDA response is the last in a chain of "scare dominoes" that begins with an activist-group's claim and gathers political steam as it moves through the insufficiently analytical media.

Government-Accepted Mercury Levels in Fish Are Deadly

The FDA strictly warns pregnant women about the dangers to fetuses resulting from mercury in some fish. In January 2001, in response to extensive studies and focus groups with pregnant women, the agency issued clear warnings that pregnant women not eat shark, swordfish, king mackerel, or tilefish and limit consumption of any other fish to about the equivalent of two tuna cans weekly.

That advice wasn't alarming enough for the Washington-based Environmental Working Group and a Public Citizen sister group called the U.S. Public Interest Research Group Education Fund.1 In an April 2001 report called "Brain Food: What Women Should Know About Mercury Contamination of Fish," the groups argued that the tough, clear government warning is insufficient and puts women at risk. Their scientific basis? A Centers for Disease Control study that reports average mercury levels in women are not of concern, but that 10% of adult women have mercury levels that exceed what it considers safe. In other words, the activists base their alarm on a minor finding in a small study that has nothing to do with pregnant women, and nothing to do with fish, and that finds high mercury levels in 10% of its subjects.

The Environmental Working Group followed up in early 2002 with a paper arguing with selective quotations that transcripts of FDA meetings show the agency deliberately downplayed warnings about mercury as it devised its standards.

The paper is of rather reedy integrity. For example, on page two it strings together a private citizen's speculation about links between mercury and Attention Deficit Disorder in her child with an FDA scientist's vague response, implying falsely that the FDA makes a link between the controversial disorder and fish contamination.

The Environmental Working Group isn't new to exaggeration and error: In early January 2001, it informed reporters that it had damaging information about Gale Norton, the Bush administration's then-nominee for Interior Secretary. Oops, the group had to admit after kicking up the dust, wrong Norton.

But for the purposes of setting scare dominoes in motion, the quality of the analysis in the deadly-fish reports didn't matter. Nor did the fact that the FDA had recently set strict fish-consumption standards. Wire services and the nation's major newspapers carried the scare prominently, some on page one. Political pressure mounted, and by March 2002 the last domino fell: The FDA agreed to set up a panel to review its own brand-new advice.

Public confusion and wasted resources at the FDA aren't the only consequences of this chain of events. It also distracts the FDA from disseminating and implementing properly its existing mercury warnings and standards-a shortcoming for which the agency has been criticized by the GAO in the past.

Newly Government-Approved Drugs are Deadly

The FDA's primary drug-related mission is to bring new medical treatments to patients safely and quickly. In the agency's own words, it's "to promote and protect the public health by helping safe and effective products reach the market in a timely way." Despite that, as pharmaceutical companies made dramatic advances in treatment through the 1980s and 1990s, patients weren't reaping the benefits. The approval process simply slowed down, with the FDA in 1992 taking a sclerotic 2.5 years, on average, to review and approve an application for a new drug.

In response, Congress passed bipartisan legislation to reduce the delays. The FDA began collecting user fees and with that revenue streamlined its approval process, which by 1998 dropped below 12 months.

While the improvement made even Democrat critics of the pharmaceutical industry happy, activists were displeased. Most recently, a spokeswoman for the National Women's Health Network argued on National Public Radio in May that it was compromising for the FDA to take money from the companies it regulates.

And last summer, perennial drug-industry, gun-industry, and tobacco-industry critic Jennifer Washburn slammed the FDA reforms in an article in the policy journal The American Prospect. The activists' theme: Speedier drug approvals, facilitated through illegitimate user fees, raised the risk that deadly drugs would get approved. Proof of this risk becoming reality was seen in a series of high-profile withdrawals of new drugs since 1993. Mainstream newspapers gobbled the theme up, with the Los Angeles Times on December 20, 2000, running a mammoth, 13,000-word article, starting on page one, under the headline: "How a New Policy Led to Seven Deadly Drugs."

The flaw in the argument? Dangerous-drug withdrawals have actually declined since the new policy kicked in, as anyone who calculates the percentage rates can see. Independent Women's Forum research shows that in the eight-year period before user fees (1985-1992), there were 170 new drugs (new molecular entities) approved and seven drugs withdrawn for reasons of health risk-a 4.1% withdrawal rate. In the eight-year period since user fees (1993-2000), there were 259 new drugs approved and nine drugs withdrawn-a 3.5% withdrawal rate.

This basic mathematical calculation is conspicuously absent from all the critical commentary this author reviewed, including the Los Angeles Times' opus. The most egregious omission of the withdrawal-rate data occurs in a widely cited May 1, 2002, article in the Journal of the American Medical Association, which raises fears about newly approved drugs. Omitting the data isn't the only flaw inthe article by Sidney Wolfe, director of Public Citizen's Health Research Group. It starts by scaring readers with the noteworthy, if highly selective, data that five drugs approved in 1997 have been withdrawn from the market. From there, it goes on to argue that dangerous or fatal effects of drugs are widespread but little-known to patients. It analyzes 24 years of approved drugs, measuring withdrawals and "black box" warnings about risk of death or serious injury. It excludes, however, "black box warnings that were present when a drug first appeared in the Physicians' Desk Reference (and) black box warnings that a drug should be administered by a qualified physician."

After all that slicing and dicing, Wolfe and his co-writers find merely that 10% of new drugs approved between 1975 and 1999 ended up featuring "black box" warnings or being withdrawn.

That minor finding doesn't stop the activist authors from tipping the scare dominoes. They conclude: that "patient exposure to new drugs with unknown toxic effects may be extensive"; that U.S. clinicians should avoid new drugs where older, "similarly efficacious agents" are available; that the FDA should tighten its approval policies for new drugs; and that where safe and effective therapies already exist "any new drug should be considered a black box."

The Wolfe article triggered numerous follow-ups in the mainstream press-none of which crunched the easily obtainable numbers on approval rates, and few of which prominently attributed the article to Public Citizen, choosing to call it a JAMA article or citing the less known authors instead.

At the FDA, the cost of activists' misrepresenting the danger of newly approved drugs has been high. A renewed climate of risk-averseness causes patients to wait longer for new drug treatments and to lose others altogether. Drug approvals have slowed back down to 1.5 years. Meanwhile, the activists continue to oppose new drugs and user fees-even opposing a plan designed to satisfy their concerns by earmarking user-fee revenues for the study of drugs' safety after the drugs get approved.

Diet and stomach-discomfort drugs pose a deadly hazard that women cannot manage on their own.

The FDA in March 2000 withdrew from the market a diabetes drug called Rezulin, after it was linked to the fact that 2.2% of patients using it suffered liver damage that was in some cases fatal. Any fatality resulting from prescription drugs is alarming. Nonetheless, it's noteworthy that Rezulin patients were warned and monitored because of the drug's liver toxicity. What's more, the Rezulin case demonstrated that the FDA system, under which drug effects were monitored after the drug was on the market and then caused it to be pulled, clearly worked. No matter-the withdrawal was a watershed event: Activists accused the FDA of dragging its feet and conspiring with drugmakers on Rezulin. This, combined with the deluge of criticism of new drug approvals discussed above, put the agency on the defensive.

In a series of cases following Rezulin, the FDA decided to say "no" to risky diet and stomach-discomfort drugs first, ask questions later: The idea that women and their doctors could safely manage risks themselves was all but abandoned. Consider the case of Lotronex, a drug for treating diarrhea in women suffering from Irritable Bowel Syndrome. When approved in 2000, it quickly attracted some 150,000 users. 13 The drug was dispensed with special warnings for clinicians and patients because of associated risks of potentially fatal intestinal inflammation and severe constipation. But after seven users died and over 100 were hospitalized, allegedly because of the drug, the FDA mounted pressure on Lotronex's manufacturer, and GlaxoSmithKline withdrew the drug within a year after approval. It seems that even when a drug's harmful side effects are understood and conveyed clearly to patients, scare dominoes can trigger its withdrawal.

It took two years and a deluge of complaints from users to convince the FDA to allow Lotronex back on the market. It now features-wisely-even more elaborate warnings and restrictions on who can take it. Yet activist groups such as Public Citizen opposed its return, with Public Citizen's Sidney Wolfe even appearing on the roster for a public FDA hearing on the subject in April, to take a consumer rights position opposite to that of Lotronex consumers. And that's not Wolfe's only patronizing stand: He doesn't like the patient-information leaflets one collects with a prescription at the pharmacy, arguing they contain faulty information that patients can misunderstand, "leading to needless drug-induced deaths."

Public Citizen has other diet drugs for women in its sights besides Lotronex, and it has the FDA jumping to respond to its criticisms. No sooner had the group petitioned the FDA about potentially deadly side effects from a dietary supplement called Ephedra, than the FDA moved to ban a Utah producer from manufacturing the product.15 Next up is Abbott Labs' diet drug Meridia, which Public Citizen in March asked the FDA to remove from the market because of side effects.

To be sure, some of these drugs may indeed be fatal to some users, and possibly belong off pharmacists' shelves. But that's not what's at issue here. When activists succeed in hounding the FDA into banning drugs within months of their complaints, without careful FDA analysis of the actual risks, then the agency's scientific benefit-risk analysis is revealed to have broken down. What's more, informed, conscientious patients who benefit from safe use of the drugs, and are left without them, suffer. The FDA's director for drug evaluation and research, Janet Woodcock, denies the FDA response to activists' political pressure. But she admits it's there; " I think the (drug review) teams feel that." She adds that "There's the same kind of political spectrum inside the FDA as without," an observation that hints at activists finding a sympathetic ear among some FDA insiders.

Nail Polish Causes Birth Defects; Water is Harmful to Pregnant Women

Hot on the heels of the Environmental Working Group and Public Interest Research Group collaboration on fish is their new study arguing chlorinated tap water is dangerous to pregnant women.

Not stopping there, the Environmental Working Group is also warning pregnant women not to use nail polish because it can contain phthalates, megadoses of which can cause birth defects in rodents. The activists go on to criticize the FDA for failing to test cosmetics for the chemicals. It remains to be seen whether the FDA responds to the criticism with policy changes, or avails itself of the conclusions already drawn by its sister Center for the Evaluation of Risks to Human Reproduction: phthalates raise no red flags at this time.

Of course, there's a risk the cosmetics industry will get toppled by the Environmental Working Group's scare dominoes on nail polish just as the Consumer Product Safety Commission and toy industry were knocked down by the activists on phthalates in baby teethers and rattles: Despite the commission's finding that phthalates posed little or no harm to babies, all the main baby-toy manufacturers moved to stop making teethers and rattles with plastics containing phthalates in 1998.

Rigorously Applied FDA Science, Public Outreach

The opportunity cost of the FDA focusing on the scare dominoes that activists set in motion is high. Already, drug approvals have slowed. Regulators are distracted from current projects to respond to the activists' agenda. The suggestible public becomes confused and suspicious as regulators appear at times overly lax and at other times overly skittish about new drugs. The FDA message is inconsistent.

The way to counteract "scare dominoes" is for the FDA to maintain tough, scientific standards on a threshold level of public risk to which it will respond with regulatory changes. This is, of course, the principle on which the FDA already operates, but the agency clearly deviates from it when the political heat is turned on. The FDA must also reach out more effectively to the public, and counter the misrepresentations of risk by putting them in context. Ideally, every single media story about a health risk should feature an FDA comment that puts the risk-level in context.

Only with aggressive outreach and scientific thresholds will the agency become able to counter scares with sense.

To find out more, visit the Independent Women's Forum website.
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The FDA or the Federal Reserve do we really need them? What have they actually accomplished? Not much I am afraid.

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