Michael R. Peskin, M.D., served as medical consultant for this article. Peskin is a board-certified gastroenterologist who operates a private practice and is currently on the board of directors of Greater Laurel-Beltsville Hospital in Laurel, Maryland. He has done medical research at the Walter Reed Army Institute of Research and was chief of medical services of the US Army in Korea. He does a radio program on health-care issues on WLMD in Maryland and is working on a consumer health program for cable television.
Who's one of the five most important figures in the pharmaceutical industry? According to an informal survey by Drug Topics magazine of key individuals familiar with drug marketing, professional practice, drug law, and regulation, physician Sidney M. Wolfe makes the list. But he's not a drug company executive. Nor a biochemist developing pathbreaking wonder drugs. Sidney Wolfe is a self-appointed—and very visible—advocate of consumers' interests in health-related matters.
During the past decade, Wolfe has appeared before Congress more than 40 times. That means approximately every three months he speaks out on Capitol Hill, presuming to represent the otherwise voiceless consumer in the political process. As the consumers' knight in shining armor, he has testified on, among other things, Darvon, generic drugs, medical devices, medical record confidentiality, cancer research, asbestos, drug patents, product liability laws, food additives, health insurance, and nuclear power emergency planning. If it's remotely related to health matters, Wolfe is usually there.
And Wolfe's influence spreads well beyond Capitol Hill. His comments are a ubiquitous presence in the pages of major newspapers and popular magazines. In a several-month span in 1984, he could be found quoted in the Los Angeles Times criticizing the Food and Drug Administration (FDA), in the Wall Street Journal scoring a major drug company, and in the New York Times, regularly, on everything from FDA regulations to birth defect home-testing kits to irradiation of food.
Over the past few years, articles by or about Wolfe have appeared in Reader's Digest, US News and World Report, Harper's, Consumer Reports, Prevention, Science News, Aviation Week, and Industry Week. He's been the subject of interviews in USA Today and People magazine. The nationally syndicated Phil Donahue Show even devoted two full hours of programming to interviewing Wolfe about the bestseller Pills That Don't Work, which he coauthored.
Clearly, Wolfe has exposure—and clout. In the 13 years since he left his career in medical research at the National Institutes of Health, he's led crusades, often successfully, against products as varied as a red food coloring, a drug for morning sickness, and one kind of smoke detector.
Wolfe's visibility has come as director of the Health Research Group (HRG), co-founded by Wolfe and Ralph Nader in 1971 and now part of the Nader-associated consumer advocacy group Public Citizen. Wolfe heads a staff of seven at HRG, including one other doctor, several lawyers, and staff associates. The group says its $260,000 annual budget comes primarily from small contributions from individuals. This could not be confirmed through the Foundation Center in Washington, D.C., where staff members were puzzled to find that the center has no data on Public Citizen or the HRG.
As director of the HRG, Wolfe has railed against the Food and Drug Administration and drug companies alike. He is a constant critic of doctors, who "charge too much." In fact, overcharging is a theme, along with high profits in the health-care industry, that he frequently returns to. Testifying before Congress, Wolfe has characterized the market system as "greedy." He has charged that profit concerns outweigh all others in the drug and food industries, even to the extent that corporations will lie to protect their products, however dangerous to the public they might be.
Unquestionably, Wolfe has succeeded in putting his views on health matters on the public agenda. The question is whether this is a boon for consumers.
With this in mind, I set out to examine Wolfe's and HRG's record—talking to doctors, scientists, journalists, government regulators, and Wolfe himself. I looked at scientific studies pertaining to a number of health crusades Wolfe has spearheaded and pored over his congressional testimony. What I compiled was a picture of a man who has had almost phenomenal success in getting media attention and in influencing health-care policy. But I also found ample evidence of less-than-thorough research.
Despite what seemed to me to be obvious flaws in Wolfe's record, I could find few individuals willing to openly criticize him. Time and again, critics asked to have their comments remain off the record or at least unattributed—even where the comments were favorable. So successfully has Wolfe managed to present himself as the consumer's benefactor that critics said they feared that to attack Wolfe publicly would undermine their own credibility as defenders of consumers' interests.
Wolfe does much to fuel that perception. He himself minces no words on his critics. Those, for example, who criticize his opposition to using irradiation in the preservation of food are quickly dismissed by Wolfe as blindly pro-nuclear. Those who recommend an easing of FDA regulations are characterized as nothing more than ventriloquists for Ronald Reagan. In conversations with me, critics also noted the HRG's ready use of lawsuits to further its ends and expressed fear of legal action if they challenge Wolfe.
Still, off-the-record at least, doubts about Wolfe and his work abound. A number of themes weave a common thread through this criticism. Among the most important of these are concerns that Wolfe is selective in his use of data, that he frequently overemphasizes the negative aspects of evidence, and that he often exaggerates the dangers he alleges are present.
These critics also pointed out, however, that Wolfe normally comes well prepared to advocate his position and always has some documentation (however valid) to support it. The trouble is, as one former FDA official who had direct dealings with Wolfe told me, "Once he gets on a track, no amount of evidence to the contrary will convince him otherwise." When Wolfe believes, he apparently believes.
My own investigation showed other problems with Wolfe's work. For one thing, he is a man of contradictions. His arguments are frequently inconsistent. For example, he favors making potassium iodide available to the general population as part of an emergency preparedness program in the event of a nuclear power plant accident, despite the fact that potassium iodide can have serious side-effects for some individuals. Those individuals, says Wolfe, could be protected from harmful effects by including warning labels with the potassium iodide to indicate who might be at risk.
In the case of food dyes, on the other hand, Wolfe takes the opposite tack. Though the food coloring Yellow Dye No. 5, used in lemon soda, for example, may cause allergic reactions in less than 0.2 percent of the population, he urges a complete ban on it. Even a package label warning the easily identifiable group that might be allergic to the dye would not satisfy Wolfe in this instance.
Wolfe would probably respond that the two cases are different. In the case of a nuclear power plant accident, he would say that the benefits provided by potassium iodide against radiation are great (though experts disagree), therefore some risk taking is warranted. Yellow Dye No. 5, however, has no benefit at all, according to Wolfe. Indeed, in his typically rhetorical parlance, the "function of the dye…is to deceive or defraud the public." So no risk, not even to a tiny segment of the population, is warranted.
But this argument merely serves to highlight another problem with Wolfe's work. He seems entirely to forget that benefits have a subjective dimension. People may like yellow drinks. Or, in the case of saccharin, another food additive Wolfe wanted banned, they may prefer it over other sweeteners, whether or not it confers any biological benefit. In his testimony before Congress, Wolfe gives no inkling that he has ever contemplated such considerations. Perhaps his response in an interview in USA Today to the question, "Would you eat a hot dog?" best indicates the inconsistencies in his own logic. He answered: "As a treat. I still like the taste." Apparently, it's okay for him to choose to eat hot dogs high in salt and fat content, which may contribute to health problems. But it's not okay for others to choose to drink lemon soda with Yellow Dye No. 5, though they are not even allergic to the dye, because Sidney Wolfe doesn't think appearance is an important characteristic of food.
Equally indicative of the contradictory nature of Wolfe's positions are his pronouncements about desirable solutions to health-care problems. He repeatedly insists in his congressional testimony that he favors market solutions. Yet the Health Research Group's own literature proudly notes that it has supported government bans on numerous drugs and food additives; it has pushed for mandatory package inserts for a variety of products; and it has advocated all manner of regulations on the use of various chemicals.
Regarding health-care costs, despite his expressed enthusiasm for markets, he clearly urged in 1976 in testimony before Congress that the best way to ensure that people have access to adequate health care would be to enact "a truly comprehensive national health insurance program"—that is, government-provided health care, as in Great Britain.
Maybe Wolfe is simply ignorant of the ways that markets historically have responded to consumers' needs, even regarding health and safety concerns. Or perhaps he doesn't understand the difference between regulatory measures that involve coercion and solutions that arise from the voluntary interactions of individuals expressing their preferences in the marketplace. It didn't take a government regulation to get the makers of Tylenol to lead the industry in introducing tamper-proof packaging. Whatever the reasons for Wolfe's contradictory pronouncements, it is difficult to square his actions with a perspective that considers the marketplace a friend of the consumer.
Given the image of Wolfe painted by his critics and the contradictions in his own writings and testimony, I was particularly anxious to talk to Wolfe himself. How would he respond to his critics or explain his inconsistencies? After several weeks of phone calls, he finally agreed to an interview, which was conducted in his offices in Washington at the Health Research Group's headquarters.
Wolfe is a tall, slender man with an ingratiating manner who clearly is well versed in working with the media. Prior to our interview, he had asked for a copy of REASON, which he obviously read with care. Throughout our conversation, he went to some lengths to emphasize that the Health Research Group really is in favor of market solutions to problems. Wolfe had obviously done his homework.
I asked Wolfe the obvious question first: Why did he choose a career as an activist rather than going into private medical practice? He said that private practice had never been his goal when he entered medical school. Initially, he had intended to do "traditional medical research," believing he could "do more useful things in terms of larger numbers of people by doing research on issues having to do with health." But after five years at the National Institutes of Health performing the sort of traditional medical research he speaks of, Wolfe says he came to the growing realization that "there were a large number of scientific issues that had been researched, studied, and conclusions had been reached, and yet the obvious public policy implications had not been done. It just seemed that there was a huge vacuum there." Wolfe proceeded to move into it.
The specific incident that led to the initiation of Wolfe's crusade against the health-care establishment involved the recall of allegedly contaminated intravenous solutions. According to Wolfe, when evidence surfaced concerning the contamination of certain intravenous fluids, a deal was made between the manufacturer and the Food and Drug Administration whereby the fluids were not pulled off the market altogether. So incensed was Wolfe when he learned of this that he mounted a campaign, which was eventually successful, to demand that the fluids be removed from the market. Wolfe recollected that afterwards "a lot of people started writing and calling in, and so I started the group (Health Research Group) in November of 1971."
Over time, the callers have reportedly evolved into a network of informants within government, industry, and elsewhere who tip Wolfe off to problems in health-related areas. When asked how he sets priorities and decides which complaints merit attention, Wolfe recited a relatively straightforward set of four criteria. First, he determines how many people are affected by the alleged problem. Second, he attempts to assess how severe is the impact. Third, he looks at whether the evidence pointing to a problem is good. Finally, he attempts to determine whether there is any possibility or likelihood that by working on the issue a change can be made.
Wolfe's criteria sound reasonable enough, so it is important to see how well he adheres to them. Equally important, once he focuses on a particular issue, what kinds of policies does he pursue to bring about change? It is this that determines whether the consumer benefits from his efforts.
In the Summer 1984 issue of Public Citizen, a publication put out by the Ralph Nader umbrella organization that includes Wolfe's Health Research Group, an article appeared that challenged the FDA's proposal to permit the use of irradiation as a means of preserving food. In supporting its proposal, the FDA, according to the article, "stressed that treatment of food at the levels of radiation proposed would add no radioactivity to the foods, nor would it expose consumers to any radioactivity." Indeed, the FDA pointed out that irradiation might even replace controversial chemical fumigants such as ethylene dibromide (EDB), which some consider to be a cancer-causing agent. (This is the substance that created a furor last year when found in trace amounts in packaged muffin mixes and similar products.)
Support for irradiation was reiterated by the American Medical Association, which claimed that "food preservation and elimination of pesticide damage to food is vital to the maintenance of an adequate and wholesome food supply." In years of research, noted the AMA, "there has been no demonstrable adverse effect on health of food irradiation for food preservation and elimination of pests."
At least 28 countries have approved treatment of food by irradiation to extend shelf life and minimize spoilage. This approval came as a result of over 50 years of research into the use of irradiation to preserve food, including numerous studies to test its safety. Still, Wolfe is not convinced. The Public Citizen article quoted him as saying, "The FDA loses whatever scientific credibility it may have by declaring food irradiation with all its problems to be be safe."
Those are strong words, although typical of the way Wolfe portrays his opponents. Wolfe then went on to say, "The safety of irradiated food can only be determined by adequate long-term testing on animals, especially because some studies have already found irradiated food to be unsafe."
Unsafe? What studies is Wolfe talking about when the FDA and AMA have come to the opposite conclusion from his?
Wolfe's and the HRG's position on food irradiation is based primarily on four studies, three of which are referred to in the Public Citizen article. On investigating these studies, however, I discovered that three of them, one of which was conducted in India and two in the Soviet Union, were found to be invalid upon peer review. The fourth, commonly called the Raltech study, used levels of radiation up to 60 times the level proposed under the FDA rules and was also considered by irradiation experts to have no validity concerning the proposed FDA action.
When I asked Wolfe about the questionable validity of these studies and pointed out that a group of international agencies led by the World Health Organization has found food irradiation safe, Wolfe refused to budge. "FDA bureaucrats" he insisted, "say the World Health Organization has no basis for doing that (approving food irradiation as safe)." About the questionable validity of the studies, Wolfe said, "What are they talking about?" He claimed that the Soviet studies were replicated in the Raltech study and characterized the criticism of them as "facile." Moreover, Wolfe said that as far as he knew, the actual data from the Soviet studies had not been reviewed by US government researchers, leading him to remark, "I don't see what their basis is for criticizing these studies."
Wolfe seemed so sure of his facts that I called the US Department of Agriculture's Eastern Regional Lab to check out his claims. There I spoke with Dr. Eugene Wierbieki, a leading research scientist intimately familiar with the food irradiation studies in question. Indeed, Dr. Wierbieki is the scientist who actually translated the Soviet studies into English.
"He's wrong," said Wierbieki when I recounted Wolfe's remarks. Contrary to Wolfe's belief that US researchers did not have the Soviet data, Wierbieki had seen the complete Soviet studies and had actually spoken with their authors. The authors of the Soviet studies themselves had admitted to Wierbieki that their findings were invalid because of the inadvertent use of spoiled meat as a subject of irradiation.
Wierbieki was also familiar with the Indian study that Wolfe cited. Again, Wierbieki told me it was invalid and in fact had been withdrawn by the institute at which it was conducted. And with regard to the Raltech study, he noted that the level of radiation used to treat the food, 5.9 megarads, was nearly 60 times that under consideration at the FDA. This led him to conclude, "I don't think that Raltech had any relevance to the 100 kilorad range (the actual level proposed for the food irradiation process)." In a separate conversation with one of the world's leading experts on the subject of food irradiation, Dr. Jack Sinisky of the consulting firm CH2M, I was also told that "the 5.9 megarad range (used in the Raltech study) is of little concern to the food irradiation industry." In other words, none of the four crucial studies used by Wolfe as a basis for opposing food irradiation provided valid evidence to support his conclusions.
I also questioned Wolfe about his reference, in an April 1984 HRG study, to an unpublished FDA review of 413 studies of food irradiation. Wolfe claimed that this extensive review provided no evidence that food irradiation is safe. But the FDA scientists who actually did the review claimed otherwise when I spoke with them prior to talking to Wolfe. When I pointed this out, Wolfe's only response was to disagree with the government officials. "That's their interpretation," he said, offering no explanation or evidence to the contrary.
At least in the case of food irradiation, the FDA official who suggested that Wolfe, once on a track, is often unwilling to accept contrary data, seems to be correct. But is this an isolated incident?
A look at another crusade by Wolfe suggests otherwise. On June 4, 1981, the HRG petitioned the Department of Health and Human Services (HHS) to remove the prescription drug Bendectin from the market immediately. An accepted medical tool for nearly three decades, Bendectin was clearly the drug of choice among physicians treating women who suffer from severe nausea during pregnancy. Despite the long experience of obstetricians, however, Wolfe asserted (as he still does today) that the drug was ineffective and even harmful. Shortly after receipt of the petition, the HHS rejected it, so the Health Research Group set off on a public crusade against the drug. At about the same time, a number of lawsuits over the drug were initiated, claiming it had caused birth defects in the children of mothers who took it.
HRG's two-year crusade to ban Bendectin and the publicity generated by the lawsuits over Bendectin were effective in turning the tide against the drug. Increasing litigation sparked by the publicity led to escalating legal and product insurance costs for Merrel Dow (the drug's sole manufacturer). In fact, according to Private Practice magazine, the insurance costs rose to over $10 million, while US sales of the drug itself were only about $13 million annually.
Faced with such astronomical insurance and litigation costs, Merrel Dow finally decided in 1983 to settle the major class-action lawsuit brought against them and to withdraw the drug from the market. Even before the withdrawal, however, consumers had already begun to suffer from the controversy, as the price of the drug rose from 30¢ to nearly $1.00 per tablet in the face of rising insurance and litigation costs.
Heralding their victory, the HRG proclaimed that withdrawal of Bendectin from the market would mean "thousands of pregnant women and their unborn children will be spared the risk of exposure to this questionably effective and unsafe drug." Yet what evidence was there to support these HRG claims? According to Dr. Ervin Nichols, Director of Practice Activities of the American College of Obstetricians and Gynecologists, "they have removed the one drug that has probably been tested more than any other drug used by pregnant women, and which has a great record."
When I asked Wolfe about the drug's safety, he noted that there was a German study questioning the safety of Bendectin. I pointed out that the study had been found invalid, because no one could replicate its findings. Wolfe retorted that no one had tried to replicate it. However, even at the time of an HRG request in 1983 that Bendectin be sold only with labels warning of possible birth defects, an FDA spokesperson stated that a second study by the same German scientists had failed to obtain similar results.
More important was an article in the March 1983 issue of the New England Journal of Medicine reviewing the medical literature on Bendectin. The article stated, "concerns about the teratogenic (birth defect) potential of Bendectin should be allayed, since none of these studies showed, within the limits of statistical certainty, that the product was teratogenic."
When confronted with this evidence, Wolfe told me that HRG's first criticism of the drug concerned only its efficacy. But the fact remains that the fundraising literature from his organization, as well as HRG's second petition to the FDA, and numerous statements to the press all emphasize the safety aspects of the antinausea medicine. In fact, a fundraising letter from Public Citizen claims credit for pressuring "Merrel Dow to remove its morning sickness drug from the market. The drug has been linked to a severe birth defect, diaphragmatic hernia." This was the birth defect cited in the German study that didn't hold up.
Even on the efficacy issue, Wolfe appears to be wrong. Many physicians I interviewed agreed that Bendectin is effective.
Thus it appears that the real losers in the Bendectin controversy are the pregnant women who suffer from severe vomiting in their first trimester, as well as their unborn children. From 2 to 3 percent of the 3.5 million women who become pregnant each year fall into this category. For them, there is no longer a safe and effective medication to alleviate their symptoms. Some physicians even fear that as a consequence these women and their children will suffer from an increased incidence of birth defects, stillbirths, spontaneous abortions, and other health consequences.
The American College of Obstetricians and Gynecologists stated on June 10, 1983, "The decision of Merrel Dow creates a significant therapeutic gap. Nausea and vomiting in pregnancy cannot always be treated by symptomatic means, and in the past years severe cases have led to serious maternal nutritional as well as other deficiencies. We understand the Merrel Dow decision in view of the present legal climate, and feel that this decision was based more on the current litigious environment than science." The New York Times characterized the Bendectin settlement as a "devastation," and Merrel Dow called the drug the "victim of a litigious society." And Dr. Ervin Nichols concluded about the campaign launched by Wolfe and the HRG: "In an attempt to do good, they did bad."
Central to both the food irradiation and Bendectin examples is the question of risks and benefits. Wolfe was quick to agree when I interviewed him that "you have to look at the risks and benefits." But just how does he measure the risks? It seems that time and time again, all he looks at are the risks—and they're the risks as he defines them. Take, for example, his crusade against ionizing smoke detectors.
There are two types of smoke detectors being manufactured in the United States today. One, the photoelectric unit, uses a light cell to detect the presence of smoke. The other, the ionizing unit, uses a minute chip of a radioactive element, americium, to detect smoke. Each of the units has some advantages over the other, in that ionizing units detect smoldering fires more quickly, while photoelectric units detect smoke more rapidly. Ionizing units are far more common, because they are far less expensive—often costing only 25 percent of what is charged for a photoelectric model. Wolfe, however, does not like ionizing units. In fact, his HRG published a paper calling them "Mindless Dangerous Technology."
Published in 1976, but still available through HRG, the report, along with supporting material, warns that "chips of americium can come loose on a cleaner's fingers," and cautions that "even industry is concerned about the hazards associated with alpha-emitting sources" (the type of radiation americium puts out). The HRG recommends that owners of ionizing smoke detectors replace them immediately with a safer alternative. The report goes on to declare that "ionization smoke detectors represent an unnecessary risk of exposure to radiation and we have asked that they be taken off the market."
The HRG also raises the specter of danger to firefighters, noting that in the event of a warehouse fire, where the warehouse contained, say, 1,000 smoke detectors, firemen would run the risk of exposure to some 3,000 microcuries of americium (a microcurie is a measure of volume). What they fail to note, however, is that 3,000 microcuries—the amount contained in all of the smoke detectors in the hypothetical warehouse—is actually less than 1/1,000th of a gram. Moreover, firefighters normally would be wearing breathing equipment, making the already remote possibility of exposure even more remote. Also, it should be remembered that the type of radiation emitted by americium—alpha particles—is the least penetrating and would be stopped by clothing or even a piece of paper.
So why all the fuss? Simple—Sidney Wolfe apparently doesn't want anyone to be exposed to any radiation. Ignoring his own dictum about costs and benefits, he would deprive the public of this potentially life-saving device because of his own narrow perspective regarding radiation.
But does Wolfe really have any impact on the public's buying habits? Consumer Reports magazine apparently thinks so. Specifically addressing fears about radiation emissions from ionization detectors, the magazine explained in its October 1984 issue: "Ionization units which contain radioactive material make some people nervous. But the risk is minimal—the rough equivalent, say, of moving from an apartment to another on the floor above, and thus moving that much closer to the sun." Moreover, because of the different properties of the two types of units, Consumer Reports recommends that purchasers either buy a combination ionization/photoelectric model or make sure that one of the detectors in their home is an ionizing unit.
But despite the fact that Consumer Reports is more often than not an ally of Wolfe's, he continues to be adamant in his opposition to ionization units. What's most disturbing about this opposition is that some people, taking these fears to heart, might not purchase any smoke detector if all they can find is an ionizing unit or if the cost of a photoelectric unit seems prohibitive. While the risks associated with radiation from ionizing units are so small as to be of no consequence, the risks of not having a unit are considerable. The International Association of Fire Chiefs estimates that as many as 7,500 lives are lost each year that could be saved if every dwelling were equipped with a smoke detector. The National Fire Protection Association reports that more than 90 percent of fire fatalities in 1982 occurred in homes without detectors. Therefore, if one were to weigh the benefits and risks, as Wolfe says we should, they are clearly on the side of having ionizing smoke detectors available to the public.
The tendency to focus on relatively minute risks is not a new phenomenon with the Health Research Group. One of the victories they claim is in obtaining a government ban on Red Dye No. 2, a substance once widely used as a food additive.
During the early 1970s, a controversy arose over Red Dye No. 2 due to claims by some researchers that it might be linked to cancer or birth defects. Evidence was not conclusive, however, according to a detailed examination of the controversy by Edith Efron in her book The Apocalyptics. Even FDA officials admitted this. In addition, the quality of the research on which the FDA relied to impose a ban could only be characterized as slovenly. The scientist who was originally conducting the study left the FDA in the middle of the experiment and test animals were mixed up. So researchers were uncertain as to which were from the control group and which from the experimental group. Worse, fully 80 percent of the animals died before the study was concluded, and most of their bodies were allowed to decompose so badly that they could not be examined.
Still, because of the public pressure mounted by opponents of the additive such as the HRG, government regulators decided in 1976 to ban the dye. They did so despite the fact that FDA officials recognized that the study on which they relied failed to clearly establish the dye's carcinogenicity. They were even aware that a second study had failed to confirm the flimsy evidence of the first study. If anything, the hasty banning of Red Dye No. 2 illustrates how susceptible policymakers are to political pressures that cloud available scientific fact. And Wolfe's relentless use of media publicity, dramatic lawsuits, and political lobbying indicate that he understands this policymaking process well.
No doubt Wolfe himself is convinced he is right when he sets out on a crusade such as the one he mounted against Red Dye No. 2. However, the longer one speaks with him, the more one suspects he may be unable to recognize any evidence that challenges his preconceptions.
One such preconception includes a bias against combination drugs. Wolfe asserts, for example, that "except in a few cases," physicians should not prescribe "combination" drugs (ones that contain more than one active ingredient to treat several symptoms of illnesses at once). However, numerous studies indicate that the real value of such combination drugs is that patients take them. So-called compliance studies of patients required to take more than one drug have indicated that the likelihood of a patient not taking his medication goes up dramatically as the number of drugs increases.
Although asked about this several times during the interview, Wolfe always avoided a direct answer. Instead, he criticized combination drugs from some other aspect. In one instance, Wolfe cited the drug Librax as an example of a combination drug that is not effective. However, according to gastroenterologist Michael R. Peskin, Wolfe is incorrect. For patients with certain conditions, Librax is an effective drug, and Peskin's experience in his practice supports that conclusion. Of course, Wolfe does not place much stock in physicians' experience.
Similarly, in the HRG book on over-the-counter drugs, Wolfe criticized combinations that include the drug Simethicone. Yet I was able to turn up eight studies indicating that the drug is both safe and effective. In one study by medical researchers P.C. Pellegrino and H.B. Silberner, 85 percent of the patients studied "exhibited a satisfactory response." In other words, Simethicone does work, according to a number of clinical studies conducted over the years. Why, then, does Wolfe claim it is ineffective?
What Wolfe says is that it is ineffective as an "antiflatulent," that is, it does not reduce the production of gas in the intestines. This is true, but that is not its purpose. What Simethicone does is break up gas bubbles so that the individual can expel the gas from his system more readily, and in that application it is effective. Wolfe himself has recommended, as an alternative remedy, that individuals troubled by excess gas change their diets—stop drinking carbonated beverages, for example—or that they try to stop swallowing air (a major cause of intestinal gas in some people). But what if they can't? Or what if they don't want to change their eating habits? In that case, Wolfe would let them suffer rather than rely on a drug he thinks is ineffective.
In the wake of unrelenting legal pressure from HRG, the FDA has eliminated from the market several thousand previously legal prescription drugs, including many combination drugs. The latter, according to a July 1983 article in Regulation magazine, "were banned on the grounds that they were no more effective than their ingredients taken separately." As a result of the ban, in cases where patients do require both substances at once, physicians now must prescribe each ingredient separately—at additional cost, of course, to the patient and with greater risk that the patient will fail to comply with the recommended therapy. Such adverse results Wolfe seems to overlook in his narrow preconception of what constitutes consumers' interests.
It's unfortunate for the consumer that Wolfe and his HRG so effectively push their narrow perspective into public policy. But worse still is the fact that the documentation they use to bolster their perspective is often inadequate, questionable by scientific standards, and even sometimes just plain wrong.
The March 1983 issue of Private Practice assessed a number of assertions made in Pills That Don't Work, put out in 1981 by Sidney Wolfe and the Health Research Group. The book, which has sold several hundred thousand copies, has basic errors even of addition, according to the Private Practice article. Furthermore, before it even reached the public, the information contained in the book was seriously out of date. Of the 200 drugs the book identified as those most often prescribed, only 26 were still in that category at the time of publication. Nonetheless, Wolfe failed to point this out when interviewed about the book on the Phil Donahue Show.
One must seriously begin to question the thoroughness and accuracy of all Wolfe's and HRG's work when one considers the magnitude of the errors they sometimes make. Consider, for example, his congressional testimony regarding a pest-strip marketed by Shell. According to Wolfe, a chemical called DDVP, thought by some to be toxic, accounts for about 97 percent of the weight of the chemical package. In fact, DDVP, the principle active ingredient of the device, "is incorporated into the resin strip to the extent of 20 percent by weight," the manufacturer testified.
Even where Wolfe accurately recounts the statistics produced by studies of the health effects of certain chemicals, there are serious grounds to challenge his assumptions in evaluating them. For example, there is great debate about the validity of animal studies for determining carcinogenic (cancer-causing) substances in humans. When I asked Wolfe about this he said if an animal study is positive, "in terms of cancer there has to be the assumption that if the study is done properly—large enough number of animals, and so forth—you have to assume that it (the substance being tested) causes cancer (in humans)."
His response was equally assertive about the merits of using results of high-dose animal tests as adequate evidence of carcinogenicity in humans. One would gather from Wolfe's responses that these issues are totally resolved within the scientific community. Yet the use of animal studies, especially high-dose studies, is questioned by many scientists. In a 1984 paper presented at a Consumers Union symposium, Elizabeth Whelan and William Havender noted recent studies suggesting that "estimating cancer risks at low doses from the results of experiments using high doses tends to overestimate the true risk by many orders of magnitude." One study, for example, "showed that a 100-fold decrease in dose would be accompanied by a 2-million-fold decrease in tumor risk."
Despite this kind of evidence, nowhere does Wolfe himself caution that results from high-dose animal studies may be difficult to interpret or even invalid. He didn't even mention, for example, in his testimony on food dyes before Congress that humans would have to consume 1,200 pounds of food tinted with Red Dye No. 2 each day for two years to match intake levels given to rats in the studies that showed a statistically significant increase in malignancies in female rats.
Wolfe's failure to acknowledge scientific data that shed doubt on his conclusions seems to confirm that he is not so much after the truth as he is intent on transforming health-care policy to accord with his own preferences. Those preferences seem to stem from a bias that includes distrust of drug companies, dislike of the traditional health-care establishment, a seeming fear of anything to do with radiation, a mistrust of chemicals in general, and a belief that profits in the health-care industry are undeservedly high. These preconceptions seem to underlie almost all of what Wolfe says and does.
Given the fact that Wolfe appears to have a clear-cut bias, I was curious why he has been able to gain so much attention in the press. Clearly, he has wide-ranging contacts—in fact, our interview was interrupted by a call from an investigative reporter with the New York Times who was having dinner with Wolfe that evening. Still, good reporters would have to recognize the hyperbole that often creeps into Wolfe's rhetoric and, if they did their homework, would certainly have had to discover that in many cases he appears to be selective in his choice of data. As with so many other individuals we interviewed, however, journalists were simply not willing to speak for attribution.
One reporter with a major daily newspaper, speaking on the condition that he not be identified, did offer considerable insight into Wolfe's success with the media. "He's a critic," the reporter said. "So when we get industry's side, then we go to him to get the other side." But what, I asked, about his apparent bias? "Well, of course, he's biased," the reporter continued. "He's an advocate, and we expect that. But he's always got some study to back him up, and he's always good for a quote. Besides, there's really no one else filling the role."
Another journalist also cited Wolfe's accessibility and his willingness to comment. None of the journalists I talked to, however, seemed concerned that Wolfe's presentation of facts might be selective. Several acknowledged that they expected Wolfe to be biased, saying it made for better copy and that if they did not obtain his viewpoint, they were not telling the whole story.
This assumption, that in order to balance a story a reporter must seek out "an opposing viewpoint," whether or not any opposition is merited by the facts, is well understood by Wolfe and he plays to it well. But is the public served by this practice? The answer must be no.
There are times when Wolfe does call problems to the public's attention, as with the recent case of defective heart valves. Nor can one take exception to his providing consumers with information on drugs or other products—provided it is accurate. The problem is that in his search for zero risk, he exaggerates the hazards facing society. Coupled with the willingness of the media to promote Wolfe's position, this has resulted in an environment that encourages greater government interference in our lives. The inevitable consequence of his crusades seems to be more regulation, more restrictions on what we can buy and consume, on what medicines we can take, on how we can live our lives—and often when more careful analysis than Wolfe's reveals that there is little risk involved.
The problem with Wolfe is not that others may disagree with his conception about what might make the best world for consumers. The problem is that he purports to speak for the consumer, not merely for himself, and uses the political process to coerce others into living in his world. He has managed to equate his view of reality with consumers' interests, especially in the popular media and on Capitol Hill, and to oppose all other views as anticonsumer.
A phrase Wolfe used frequently during our interview was, "Who needs it?" He used this phrase in reference to everything from over-the-counter drugs, to Bendectin, to ionizing smoke detectors. But the real question is, Who is Sidney Wolfe to say what other individuals' needs are? His sincerity cannot excuse his condescension.
In a way it's unfortunate that Wolfe is so willing to accept the government as a solution to problems, because he otherwise might be able to provide a useful service. Information is important in a market system. To the extent that the HRG could provide information to consumers, it would be performing a useful function, if—and it's a big if—the information were accurate. But that doesn't seem to be in the cards. Instead, Wolfe seems to have a burning desire to remake the world in an image he has created, whether we want him to or not.
Milton Copulos is a senior analyst at the Heritage Foundation. He writes a syndicated column, "Man and His Universe," and is on the advisory board of Consumer Alert, a public-interest consumer organization. This article is a project of the Reason Foundation Investigative Journalism Fund.
This article originally appeared in print under the headline "It’s Effective—But Is It Safe?".