“Populus iamdudum defutatus est”
“The people have been getting screwed long enough.”
— Quotation on the door of the Public Citizen Health Research Group
It has been said that Sidney M. Wolfe, M.D., has a waiting room packed with 240 million patients. Although qualified to “lay on hands,” he and other physicians on his staff have shunned a traditional fee-for-service practice for the greater challenges of public-interest medicine, a multi-disciplinary specialty that addresses the politics of health. In this brand of medicine, the diagnoses go beyond the standard evaluations of a person’s health or sickness to look at the configurations of power in the medical care marketplace, which can have equal or greater influence on the well-being of many people. Does a food manufacturer use cancer-causing additives? Has a drug maker fudged the safety research data on its new drugs? Are an industry’s workplace health and safety protections truly adequate? Are the Food and Drug Administration and Occupational Safety and Health Administration patrolling the marketplace and workplace with effective regulation and enforcement? These are the sorts of scientific, political and moral questions that are the backbone of public-interest medicine.
The tools of Dr. Wolfe’s practice are not unlike those of other Nader consumer groups: meticulous research, effective press relations, readable consumer guidebooks, well-honed rulemaking petitions, and, when all else fails, fierce litigation campaigns, in conjunction with the Public Citizen Litigation Group. By foraging through medical journals, consulting with health experts and cultivating a network of tipsters within government and industry, Dr. Wolfe and his colleagues have taken Ralph Nader’s vision of a consumer-side economy and public citizenship and applied it to the nation’s health establishment. Public Citizen’s Health Research Group pursues a vision of public health that goes well beyond the treatment of illness and injury — the chief concern of conventional medical practitioners — to promote prevention, the cheapest, most humane and effective form of health protection, and usually the most resisted when it demands a corporate response.
That preventive medicine can be disruptive to vested interests is a lesson that Wolfe learned as a student in part from pediatrician Dr. Benjamin Spock, then a professor at Case Western Reserve Medical School in Cleveland. Spock “made it very clear that it is not possible to understand people’s health problems without understanding the circumstances from which they come,” Wolfe explained. The HRG’s activism has applied this basic insight, helping to eliminate literally dozens of potent health hazards from the nation’s food and drug supply, workplaces and consumer products.
Tall, studious and doctorly, Sidney Wolfe at 52 has a precise, capacious memory and, like his good friend Ralph Nader, a deep reservoir of outrage. Wolfe credits his father, a Labor Department inspector in the Wages and Hours division, and his mother, an English teacher in a black ghetto in Cleveland, for sensitizing him to issues of social injustice. At Cornell University, Wolfe studied to be a chemical engineer but left after discovering the health hazards at one summer job. “I was leaving work every day with first-degree burns on my body from hydrofluoric acid,” Wolfe recalls. “So I decided to go into medicine, but I didn’t want to practice. I wanted to do research.”
Just before entering Case Western, Wolfe worked in a coroner’s office in Cleveland, where he encountered people who had died from drug overdoses, a problem that would later engage his attention as an activist. After completing medical school, Wolfe went on to the National Institutes of Health in Washington, where he did research in alcoholism, and cellular physiology and nutrition. In 1968, while at NIH, the 31-year-old Wolfe began consulting with Nader about various projects. Three years later, they jointly wrote a letter to the Food and Drug Administration urging the recall of millions of bottles of bacteria-contaminated intravenous fluid, which had caused 150 cases of infection and nine deaths. The mere fact that two outsiders had to prod the FDA to take such an obvious step pointed up the need for a watchdog group.
That realization, and the success of their prodding of the FDA, soon led Nader and Wolfe to found the Health Research Group, the first group to operate under the aegis of the newly founded Public Citizen. The HRG’s first crusade was a November 12, 1971 petition to the FDA requesting a ban on Red Dye No. 2, a popular yet nutritionally worthless color dye that could cause cancer. The campaign attracted widespread public attention, alerting consumers to the actual prevalence of potentially hazardous additives in the nation’s breadbasket. Five years later, after a tortuous series of scientific and legal squabbles, the HRG prevailed. The FDA banned the dye.
Since that first battle, the HRG has expanded its advocacy into other areas of consumer health. The remainder of this chapter is devoted to five primary areas of HRG activism — food safety, drug and medical device safety, women’s health, consumer empowerment and the costs of health care. (A sixth area of HRG activism, occupational health and safety, is examined in Chapter 5, Section 3.)
Patrolling the Safety of the Nation’s Food
Americans are understandably squeamish about adulterations in a product as intimate as food. More than most hazards, the integrity and quality of food is an issue that receives strong, reflexive support from the public. In two modern-day versions of Upton Sinclair’s The Jungle, the Nader’s Raiders explored food safety issues in The Chemical Feast, edited by James S. Turner (1970), which probed the performance of the FDA, and Sowing the Wind, by Harrison Wellford (1972), which documented the prevalence of carcinogenic additives and pesticide residues in the nation’s food.
Theoretically, as these books pointed out, there were laws on the books to protect Americans from such harms. In practice, however, the FDA was a captive of food manufacturers. There was little organized consumer pressure — until Nader arrived — to vigorously enforce and strengthen existing federal food laws. The Health Research Group stepped into this vacuum and became one of the first institutional consumer voices to make a sophisticated, scientific case for greater food safety. (Two other important Washington consumer groups involved in food safety are the Center for Science in the Public Interest, founded and directed by former Naderite Michael Jacobson, and Public Voice for Food and Health Policy, directed by Ellen Haas.)
One of the most bitterly contested and recurrent consumer-industry food fights has revolved around the Delaney Clause, a provision, added to federal food laws in 1958, that bans the use of any food additive that has been shown to cause cancer in laboratory animals. Food industry officials have long criticized the Delaney Clause as too rigid and scientifically questionable, and have repeatedly sought to eliminate or weaken it. In truth, however, the Delaney Clause over the past four decades has saved the American public from unnecessary exposure to dozens of carcinogenic additives.
To defend the Delaney Clause and force the FDA to enforce it, Dr. Wolfe and Public Citizen Litigation Group attorneys William Schultz and Katherine Meyer have waged an epic campaign of litigation against the assembled legal might of the food industry. The law has been clear: the Color Additive Amendments of 1960 instruct the FDA to screen all new additives and, depending upon the outcome of scientific tests for safety, either approve them or ban them. Congress set this high standard because color additives serve no therapeutic or nutritional purpose; they simply help the food, drug and cosmetic industries sell more products. Unfortunately, Congress also inserted a loophole into the law that allowed the FDA to extend the deadline for approving or banning additives by two and a half years in order to complete safety tests, and an additional authority to extend that deadline if necessary, as a last resort. In the meantime, manufacturers could still use suspect additives.
This minor clause has been greatly abused by the food industry and the FDA, which has relied on it time and time again over the past twenty-five years to keep some twenty-three additives on the market that have never been proven safe. In a series of lawsuits to force the FDA to carry out the 1960 color additives law, the HRG and Litigation Group have forced from the market a variety of color additives whose use violates the Delaney Clause or other food safety laws. By 1985, Public Citizen was still hammering away at the remaining additives — Red No. 3 (candy and baked goods), Yellow No. 5 (beverages, baked goods, pet food), Yellow No. 6 (beverages, candy, desserts), Red Nos. 8, 9, 19, 33, 36 and 37 and Orange No. 17 (drugs and cosmetics) — which resulted in a 1988 court victory against the Reagan FDA.
It is a sign of the enormous imbalance of wealth and power that the food industry and FDA have been able to evade the clear mandate of a 1960 law for so long and expose consumers to nutritionally worthless, carcinogenic additives. Yet it is also a sign of the consumer movement’s sophistication that Public Citizen (and others, particularly the Center for Science in the Public Interest) have been able to wage such protracted scientific and legal challenges.
Not all food additives or chemicals are directly added to the food supply, of course. As food travels from the farm to the dinner table, it often can become contaminated by animal drugs, food packaging, toxic molds and a blizzard of pesticides and other chemicals. Here again, Public Citizen has waged numerous campaigns to ensure that the FDA protects the public from these hazards.
For years, the FDA used informal “action levels” to regulate more than 20 substances classified as environmental contaminants. Such substances include aflatoxin, a naturally occurring carcinogen in peanuts and corn, lead, mercury and pesticides such as aldrin and chlordane. Because the FDA’s action levels were being set without any public comment or review, there was no way to determine whether the amounts deemed acceptable by the FDA are in fact safe. Prior to Public Citizen’s intervention, the FDA’s action levels (for example 20 parts per billion in corn) provided industry a safe harbor or guarantee against federal action as long as they complied with the action level. As a result of Public Citizen’s lawsuit, which went first to the Supreme Court and then to the D.C. Circuit, the FDA must either provide the public an opportunity to comment or declare that any amount of the contaminant is subject to federal action.
Over the past 18 years, the HRG and the Public Citizen Litigation Group have identified and challenged many other food safety threats, ranging from methylene chloride residues in decaffeinated coffee (a cancer risk), unpasteurized raw milk (risks of salmonella, causal illness and other diseases), and vitamin-deficient infant formula (resulting in a failure of infants to grow and thrive). Without concerted citizen action, it is unlikely that these and many other food hazards would have been identified and purged from our food supply.
A dramatic example of how a consumer-side approach to food safety can transform a particular market can be seen in the campaign against Alar (or daminozide), a chemical that makes apples redder and regulates their growth so that they can all be picked at once. When the EPA suspended its plans to ban the chemical in January 1986, even after its carcinogenic risk had been confirmed, Ralph Nader called on supermarket chains to refuse to buy Alar-treated apples. While Nader generated publicity to fuel a boycott (gaining such backers of a refusal to buy as the Safeway supermarket chain), Public Citizen Litigation Group, working with the Natural Resources Defense Council (NRDC), brought a lawsuit against the EPA to force a formal ban on the chemical. When a 1989 NRDC report showed that children face a heightened cancer risk from Alar-treated apples, even more supermarkets and apple-growers themselves joined the boycott. Finally, the EPA capitulated and agreed to a phased-in ban of the chemical. By October 1989, the only manufacturer of Alar, Uniroyal Chemical Co., citing lagging sales of Alar, announced plans to discontinue the chemical’s production.
The campaign proved to be something of a watershed in public consciousness about chemically-treated foods. In the wake of the Alar boycott, farmers began scrambling to find more benign, natural ways of raising fruits and vegetables; many supermarkets began to stock organic foods and provide more informative labeling for produce; and public expectations about the chemical contamination of food products have been greatly raised.
In microcosm, the Alar episode demonstrated how the consumer movement has, over time, altered social norms about technological hazards — in this case, chemical hazards. It also demonstrated the transformative potential of an organized consumer movement. The public’s heightened consciousness about good nutrition, for example — fueled by government nutrition research, a cultural concern about health, and the consumer movement’s advocacy — has helped bring about a new wave of more healthful food products (and pretenders to that title).
Although a great many of the HRG’s campaigns have been against a particular hazard, the consumer movement has not been reflexively in opposition. It has also worked hard to promote exemplary models of food production and marketing. In 1988, for example, a coalition led by the Center for Science in the Public Interest bestowed the “Safe Food Trailblazer” awards on such people as Purity Supreme, a New England supermarket chain that carries drug- and pesticide-free beef; the late Richard Kozlow, cofounder of the Organic Crop Improvement Association; and Raley’s Supermarkets of California, for testing its produce for illegal levels of pesticides. The awards were meant to show that the marketplace can sustain sales of safe and healthful food; what is often needed is leadership from the consumer-side and government to show that better alternatives are indeed possible.
The Center for Science in the Public Interest has developed a rather extensive advocacy for safe and nutritious food, along with numerous consumer guidebooks, colorful posters and reports. One compendium that gives a good overview of consumer concerns with food safety is Eating Clean (1987), a collection of articles published by Nader’s Center for Study of Responsive Law.
Ferreting Out Unsafe, Ineffective or Overpriced Drugs and Medical
In the firmament of health advocacy groups, Dr. Wolfe and the Health Research Group have a singular reputation: Few organizations have been as vigilant in spotting dangerous new drugs, as aggressive in trying to force them from the market, or as prolific in publishing consumer guidebooks exposing how the pharmaceutical industry sells medications that are unsafe or not effective for the intended purposes. William Cray of the Pharmaceutical Manufacturers Association scoffed to a reporter, “[Dr. Wolfe] tends to exploit every negative aspect of drug therapy to scare the consumer.” Yet FDA officials, such as former Commissioner Donald Kennedy, grudgingly concede the value of an outside watchdog: “Sometimes when I’ve been annoyed at Sid, I realized that I was really annoyed at myself for not seeing a problem to be as serious as I should have at first look.”
It is no exaggeration to say that Wolfe and his associates have been responsible for saving thousands of lives by forcing numerous unsafe drugs from the market. One of the first HRG drug campaigns was aimed at phenformin, a drug used to treat diabetes. A 1971 study showed that the drug actually increased deaths from heart complications, and an FDA spokesperson admitted two years later that the fatality rate from phenformin lactic acidosis was four cases per 1,000 users per year amounting to hundreds of deaths a year. Despite this damning evidence, it took a 1977 lawsuit from the HRG to force the FDA to ban the drug. In the process, the HRG established a valuable, new legal precedent by using a hitherto-unused provision of the Food Drug and Cosmetic Act that authorized speedy bans on especially dangerous drugs.
One of the more dramatic and important HRG campaigns against an unsafe drug involved Oraflex, an arthritis medication introduced in April 1982 by Eli Lilly and Co. with great marketing hoopla (unusual in that it was directed to the consumer) and false claims that it could heal tissues, thus actually curing arthritis. Within fourteen weeks, Eli Lilly had sold a remarkable 500,000 prescriptions for the drug and earned $30 million from it. Meanwhile, Dr. Wolfe had been investigating the drug’s performance in the United Kingdom, where it had been on the market for two years. He discovered that at the time when the FDA had approved Oraflex for use in the United States, the drug had caused at least eight deaths and ten other cases of nonfatal liver or kidney damage.
The HRG began warning patients about this serious risk, and petitioned the FDA to ban the drug. When the FDA declined to act, the HRG and the Public Citizen Litigation Group filed a lawsuit, gathered support from other public health and senior citizen groups, and stepped up its warnings about Oraflex. Finally, after the death toll in Great Britain had reached forty-five and the drug was banned there, Eli Lilly “voluntarily” withdrew the drug from the market worldwide. Only then did FDA investigators discover that Eli Lilly had known all along about the U.K. deaths and adverse reactions. Dr. Wolfe estimated that Oraflex had caused about fifty deaths in this country before its withdrawal. The penalty for such behavior, however, turned out to be appallingly modest. A federal grand jury investigation resulted in 40 misdemeanor counts and only $40,000 in fines for the company and its chief medical officer.
Because the FDA and Justice Department often have such casual attitudes toward the marketplace, the HRG has long advocated stiff criminal penalties for culpable executives, both to deter and punish. One HRG attempt to hold business leaders personally accountable involved Selacryn, a new medication developed by Smith, Kline & French (SKF) to treat high blood pressure. Only nine months after its introduction to the market, the drug had caused at least 514 cases of liver damage and 60 deaths among the 300,000 people who had taken it, prompting the FDA to ban the drug. Shortly after the ban, however, the HRG obtained information that SKF had suppressed a dozen reports of liver damage, failing to notify the FDA within fifteen days, as required by law. As a result of the HRG’s digging, the Justice Department brought criminal charges against the company’s executives, who pled guilty.
On yet another occasion, Public Citizen discovered that Ciba-Geigy, the giant Swiss drug maker, had withheld from the FDA evidence that its two arthritis drugs, Butazolidin and Tandearil, had caused at least 564 fatalities worldwide, while reporting only 101 fatalities to the FDA. Dr. Wolfe estimates that, because of the well-documented problem of underreporting of adverse drug reactions, especially deaths, the actual number of deaths from these two drugs was probably more than 10,000 worldwide and, in the United States, over 3,000. The HRG’s 1983 petition to ban these drugs was denied, but the FDA later agreed that stronger physicians’ warning labels were needed and Tandearil was taken off the market.
In 1988 the HRG brought to light yet another instance of a drug company failing to report early warnings of a drug’s potentially fatal adverse reactions. The HRG learned that, at least six months (and perhaps two years) before Hoffman-LaRoche introduced the tranquilizer VERSED (midazolam) to the U.S. market, it knew that the drug’s strong potency could cause oversedation and serious respiratory depression resulting in apnea (stopped breathing) and cardiac arrest. Internal company documents discussed the theoretical risks of using a strong concentration of the drug versus the benefits of marketing it at that strong concentration to compete with the then most widely used anesthetic drug which was marketed at the same concentration.
Even after introducing Versed to the U.K. market and recognizing its safety risks, the company did not seek U.S. approval of a more dilute dosage form of the drug for more than two years. In response, the HRG petitioned the FDA to stop allowing Versed to be used for conscious sedation where no anesthesiologist is present, the setting in which a disproprotionate number of Versed-related deaths occurred. The company belatedly lowered the potency of the drug, as it had already done for sales of Versed in other countries.
Over the past two decades, there have been literally dozens of additional drugs that the HRG has investigated and taken action against, often winning bans, forcing them from the market or obtaining stronger labeling requirements. Among the unsafe drugs: Vioform (iodochlorhydroxyquin), a drug ingredient applied directly to the skin to combat diaper rash and athlete’s foot (banned from over-the-counter drugs in 1986 because of its potentially toxic side effects); danthron, a carcinogenic ingredient in some of the largest-selling laxatives (withdrawn from market in 1987); Bendectin, a morning sickness drug marketed by Merrell Dow and suspected of causing birth defects (withdrawn from the market in 1983); and Depo-Provera, a drug for which the Upjohn Company sought FDA approval to use as an injectable contraceptive, despite evidence of a strong cancer risk (rejected by the FDA in 1983).
While the FDA is one of the obvious and most important pressure points for purging the market of unsafe drugs, private lawsuits brought by the plaintiffs’ bar also serve to keep drug makers more careful. To assist these efforts, the HRG has formed several “drug clearinghouses” that provide technical data and other useful information to help attorneys win their suits against pharmaceutical manufacturers. The HRG’s clearinghouses have dealt primarily with Phenformin, Selacryn, Oraflex, Cleocin, Zomax, intraocular lenses and the Bjork-Shiley artificial heart valve, whose defects caused the deaths of 165 people. Another clearinghouse is being started concerning silicon gel breast implants.
To help consumers avoid the special risks that some drugs hold when misprescribed or misused, the HRG has also spent much of its time pushing for consumer warning labels and “patient package inserts” for drugs. For example:
-When it was discovered that giving aspirin to children with the flu or
chicken pox can cause a rare but fatal or brain-damaging ailment called Reye’s
Syndrome, the HRG spent five years pushing a recalcitrant Department of Health
and Human Services and Office of Management and Budget to require a warning
label on all bottles of aspirin, which they did in 1986. Now the number of
Reyes cases is but a fraction of what it was earlier.
-When the Department of Health and Human Services ignored the advice of
its own scientific task force and failed to warn women exposed to the drug DES
of its newly discovered cancer risks, the HRG blew the whistle in July 1985 to
force the issue into the open.
– Because some inactive ingredients in drugs, such as lactose and
sulfites, can cause serious adverse reactions among large segments of the
population, the HRG and pediatrician Dr. Jeffrey L. Brown petitioned the FDA to
require drug labeling disclosures of inactive ingredients.
* Because many over-the-counter drugs can affect pregnant or lactating
women, the HRG has urged the FDA to expand its labeling requirements so that
appropriate medications carry adequate warnings.
In addition to promoting safe drugs and their safe use, the HRG has worked hard to promote generic drugs, which are cheaper and as effective as the brand-name equivalents. The large drug companies dislike the competition that generics entail, and over the years have devised numerous tactics to restrict their availability: state laws requiring the use of brand-name drugs unless prescriptions specify otherwise, unnecessary bureaucratic hurdles for FDA approval of new generics, and longer patent monopolies for brand-name drugs that delay the availability of generics. The HRG has strongly opposed all of these schemes.
Neutralizing the Threats to Women’s Health
A great deal of the HRG’s activism focuses on women’s health problems, addressing such issues as drugs used by pregnant and nursing women, contraceptive safety, breast implants, unnecessary breast surgery, hysterectomies and Cesarian sections, and toxic shock syndrome. In addition to Bendectin (the morning sickness drug), Depo-Provera (the injectable contraceptive) and the cancer risks of DES (a miscarriage-prevention drug used in the 1950s and 1960s), the HRG has disclosed the extraordinary risks of Accutane, an acne medication that can cause birth defects; the cancer risks of using silicon gel breast implants, which are implanted into 130,000 women a year; the cancer risks of using menopausal estrogens to treat osteoporosis in women (and therefore the advisability of using alternative methods when possible); and the excessive blood-clotting risks of bromocriptine (sold under the brand name Parlodel) and estrogens used to stop milk production and breast engorgement in women who choose not to breast-feed after giving birth.
Even though epidemiologists confirm that women who use high-absorbency tampons have a greater relative risk of developing toxic shock syndrome (TSS) — which has resulted in dozens of deaths and over 1,000 non-fatal case of TSS — there is no uniform rating scale of tampon absorbency that would allow consumers to make informed comparisons. To remedy this problem, the HRG petitioned, then successfully sued, the FDA to require all tampon boxes to display standardized absorbency information.
To discourage unnecessary Cesarian-sections for pregnant women, HRG researchers have documented the alarming overuse of this surgery and publicized it in the medical community and the press. C-sections were used in only 5.5 percent of all deliveries in 1970, but rates had escalated to 24.1 percent by 1986. The HRG contends that about half of the nearly 500,000 c-sections performed in the United States are unnecessary, wasting well over $1 billion a year. The HRG’s major study in 1987 which was updated in 1989 helped prod medical associations and hospitals to reevaluate their c-section practices and institute new policies to curb unnecessary surgery. The agitation against c-section appears to be paying off. By 1991, the National Center for Health Statistics reported that the c-section rate had levelled off at 23.8 percent in 1989, and may be headed for a decline.
As an advocate for consumers, the HRG raises questions that the medical specialties, drug companies and medical equipment suppliers do not ask, or prefer not to ask — yet questions that are usually beyond the expertise of the average consumer. For example, are the various devices used in obstetrics and gynecology — such as endometrial aspirators, fetal electroencephalographic monitors, contraceptive tubal occlusion devices and cervical dilators — safe and effective? The HRG urged the FDA to require clinical data on the safety and effectiveness of sixteen obstetrical/gynecological medical devices. When the FDA withdrew a proposed rule that would have established marketing restrictions on alpha-fetoprotein test kits, which are used to diagnose neural tube defects in fetuses, the HRG criticized the action. Without the restrictions, test results are likely to be misinterpreted by expectant parents, leading many to abort healthy and wanted children that they mistakenly suspect have a neural tube defect.
After twenty years of investigative research into health issues affecting women, the HRG in 1991 published a major resource for consumers, Women’s Health Alert. The book challenges the medical mainstream’s views on birth control, C-sections, hysterectomies, menopause, breast implants, weight-control products, osteoporosis, mammography and other medications, procedures and conditions that affect women’s health. Dr. Wolfe explains why he and the HRG prepared the book: “I have watched doctors’ and drug companies’ enormous appetite for dumping hormones and other drugs into women’s bodies. I have been awed at surgeon’s seemingly endless capacity to cut into women’s bodies, removing ‘useless’ uteruses through millions of unnecessary hysterectomies, surgically delivering ‘perfect babies’ through cesarean sections, and deforming women’s breasts by implanting silicone devices inside their bodies.” Although the mercantile forces arrayed against responsible medical decisions are powerful and numerous, Women’s Health Alert has been a valuable source of counter-information.
Empowering the Health Care Consumer
While it is important for consumers to have a representative of their own in FDA rulemakings and congressional hearings, the HRG also believes that it is important for patients to develop their own expertise about their health, medications and health care in general. To that end, the HRG has published numerous consumer guidebooks that popularize and disseminate otherwise obscure medical and scientific knowledge.
The HRG’s first best-selling book was its 1980 bestseller, Pills That Don’t Work: Prescription Drugs that Lack Evidence of Effectiveness. Because the FDA had been lax in identifying and banning drugs for which there was no scientific evidence of effectiveness, as required by the 1962 Drug Amendments, the HRG published a directory of over 600 highly suspect prescription medications. At the time the book was published, the 169 million annual prescriptions for these medications represented one of every eight prescriptions filled, and $1.1 billion in potentially worthless consumer expenditures. Since all drugs involve risks, people taking the suspect drugs were also being exposed to unnecessary dangers without compensating benefits. By selling more than 500,000 copies and attracting considerable publicity, Pills That Don’t Work, along with litigation by the Public Citizen Litigation Group to remove the ineffective drugs, helped prod the FDA to speed up its identification and bans of drugs lacking evidence of effectiveness.
The book proved to be the first of several that warned consumers of unsafe or ineffective drugs. Over-the-Counter Pills That Don’t Work (1983) itemized the ingredients in OTC drugs that lack evidence of safety and effectiveness. Here again, because an FDA review of the 300,000 ingredients in over-the-counter drug products was progressing so slowly, the HRG published a massive listing of suspect ingredients and the brand-name products that contained them. The issue was (and is) important because fewer than one-third of OTC ingredients have been shown to be safe and effective for their intended uses. Hundreds of OTC products are “combination” drugs that combine several ingredients to provide a “shotgun” approach to illness. When the book was published, Nyquil, for instance, contained four active ingredients (acetaminophen, dextromethorphan HB., ephedrine sulfate and doxylamine succinate), none of which has been proven safe and effective for the treatment of colds. Of the more than $10 billion that consumers spend on OTC drugs each year, Dr. Wolfe estimates that $3-4 billion are wasted on grossly overpriced products or products with ingredients lacking evidence of safety or effectiveness.
In 1988, the HRG released another consumer guide to a neglected area, the special dangers of adverse drug reactions among elderly people. Worst Pills, Best Pills: The Older Adult’s Guide to Avoiding Drug-Induced Death or Illness surveys 287 drugs with recommendations on how to use the medications and which to avoid entirely. The book, which sold over 1,000,000 copies, addresses a problem that had previously received little attention — the 61,000 cases of drug-induced parkinsonism, the 32,000 hip fractures attributable to drug-induced falls, the 163,000 cases of drug-induced or worsened memory loss, and the 243,000 hospitalizations in older adults stemming from adverse drug reactions.
The library of HRG guidebooks ranges widely. It includes Cataracts: A Consumers’ Guide to Choosing the Best Treatment, by Robert B. Leflar and Helen Lillie (1981); The X-Ray Information Book: A Consumers’ Guide to Avoiding Unnecessary Medical and Dental X-Rays, by Priscilla W. Laws and the HRG (1974 and 1983); Stopping Valium and Ativan, Centrax, Dalmane, Librium, Paxipam, Restoril, Serax, Tranxene, Xanax (1982), a guide to a highly addictive family of drugs for which 3.6 billion pills were dispensed in 1980, for an average intake of 95 pills per person; Taking the Pain Out of Finding a Good Dentist (1975); and Through the Mental Health Maze: How to Choose a Psychotherapist (1975).
Publishing information about different aspects of medical care is not just a good way to empower consumers but an excellent way of prodding the medical establishment to reform itself. An excellent example is the HRG’s 6,892 Questionable Doctors, the first nationwide compendium identifying doctors who had been formally disciplined by state or federal agencies. The June 1990 report was followed up a year later with 9,479 Questionable Doctors as part of the HRG’s ongoing effort to prod state medical boards to take action against doctors who engage in unethical practices or provide substandard or negligent care.
The issue is hardly academic. Based on three studies, the HRG estimates that between 150,000 and 300,000 Americans are injured or killed each year by doctor negligence. Yet only 2,600 formal disciplinary actions are taken by states against doctors each year. By bringing together into one report the not-easily-obtained facts about the nation’s questionable doctors — and the names, addresses, and phone numbers of state licensing boards — the HRG has brought new attention to a festering health care problem, instigating a powerful wave of pressure for reform among state boards, federal agencies and national medical societies.
The HRG’s campaign against “questionable doctors” is emblematic of many similar problems in our health care system, in which there is a stunning lack of data about medical performance and costs. By compiling and analyzing raw data, the HRG has helped identify wide discrepancies in the quality and costs of health care from hospital to hospital, and from doctor to doctor. One HRG study of Maryland doctors, for example, revealed that, in one hospital, a surgeon had an outrageous 10 percent death rate among his prostate-surgery patients — a revelation that came to light only because of the information disclosures. Responding to the HRG and others, the federal government and some states are now releasing comparative data on c-section surgery, medical fees, the patient mortality rates of physicians and hospitals, among other information.
Since March 1985, the HRG has published its HEALTH LETTER newsletter, now monthly, providing an informed consumer analysis of medical issues ranging from comparative hospital mortality data to the more insidious marketing tactics of pharmaceutical companies. While numerous mass-audience magazines now provide useful consumer health information, the HRG’s newsletter is one of the few popularly accessible publications that not only breaks the news but makes it, names names, draws upon the latest medical research and provides sound medical judgments from the consumer perspective.
Curbing the High Costs of Health Care
Besides helping consumers protect their health, one purpose of the HRG’s many guidebooks is to help bring down the soaring costs of health care while improving its quality. Dr. Wolfe estimates that as much as one-third of all money spent on health care in the United States in 1987 — or $180 billion of $540 billion — was wasted on unnecessary surgery, hospitalizations and other services. In numerous reports, presentations to congressional committees and petitions to government agencies, the HRG has proposed reforms to bring down medical costs without lowering quality of care. These reforms include the use of generic drugs instead of brand-name drugs whenever possible; the use of HMOs (health maintenance organizations) instead of fee-for-service care; the elimination of unnecessary surgery; reductions in physicians’ astronomical salaries; more prudent use of expensive medical technologies; and competition among individual doctors and hospitals, spurred by comparative information disclosures about performance and costs.
As the costs and administrative deficiencies of the American health care system were reaching crushing new levels in the early 1990s, the HRG convened a national conference calling for a complete overhaul of the U.S. system, replacing the 1,500 private health insurers with a single-payer government insurer. The proper model for the U.S., Dr. Wolfe has argued in numerous forums, should be the successful and socially equitable Canadian health care system. That system permits patients free choice of doctors and hospitals and provides universal access to health care, while slashing the grossly inefficient administrative overhead that plagues the current U.S. system. The HRG estimates that a more streamlined, Canadian-style system in the U.S. would have saved up to $136 billion in 1991, freeing up $3,919 for each of the 34.4 million Americans who did not have health insurance in 1990 and for tens of millions more who are underinsured.
The HRG conference in May 1991, co-sponsored by the Center for National Program Studies at Harvard Medical School/The Cambridge Hospital, dispelled the AMA-promoted myths that publicly funded health care results in long waiting lists for crucial surgery and that medical care under such a system is inferior. In fact, Canadians’ satisfaction with their health care system exceeds that of Americans’, and Canada spends less of its gross national product on health care (9 percent versus 12.2 percent in the U.S.).
Until the HRG jumped into the fray, the debate over how to reform the U.S. health care system had largely dismissed the idea of a single-payer system as too far-fetched. Now, with the mutual efforts of the HRG and Physicians for a National Health Program, the campaign for universal health care has begun in earnest. It is an uphill crusade, to be sure, because most physicians, insurers, hospitals and employers vigorously oppose a system that might rein in the prerogatives to which they have grown accustomed. Yet as the inadequacies of U.S. health care grow worse, the appeal of a single-payer system will only grow brighter.
__________ From the beginning, Dr. Wolfe has conceived the HRG’s mission as demystifying the practice of medicine and empowering consumers to make more informed health care decisions for themselves. At one level, the HRG acts as the consumers’ expert surrogate in Washington, representing an otherwise neglected viewpoint in agency rulemakings, enforcement actions, congressional hearings and other policy-making arenas. On another level, it acts as a bridge between assorted bodies of expert professional knowledge (pharmacology, physiology, epidemiology, etc.) and popular knowledge, enriching both the medical professions and ordinary consumers in the process.
It is difficult to measure the far-reaching impact that this sort of activism has yielded over two decades, but there is no question that Dr. Wolfe’s example and the knowledge that the HRG has generated have changed the practice of medicine in many large and small ways. Both the medical community and the public have a greater awareness of the risks of certain drugs; regulatory agencies and pharmaceutical companies, knowing that corner-cutting could result in adverse publicity and lawsuits, are more likely to do the right thing; consumers are more wary, informed and willing to assert their interests in their encounters with the health care system; and many physicians, in response to the consumer movement, have embraced safer and more humane medical practices. “After thousands of years of the extraordinary gap between what the doctor knows and what the patient knows,” Dr. Wolfe notes, “patients now realize it is in the best interests of their health to ask as many questions as possible. That to me is very good news.”