The Pusher in the Gray-Flannel Suit

You Smile as Your Doctor scribbles on his pad. You utter thanks as he extends the prescription. You grasp it, feeling some relief already from whatever ill your flesh is heir to--perhaps anxiety or depression, insomnia or pain.

You're glad, but should you be? What you're holding is more than a piece of paper. It's your membership card in America's largest drug culture, the pillzapoppin' world of prescription drugs. You have one of the one and a half billion prescriptions (seven per every living American) that will be written this year for one or more of the 26,000 licit drugs. It will cost about $5.98 to get it filled, your part of the 11 billion dollars the FDA estimates is spent on legal drugs each year. Each pill will be only one of the approximately 40 billion that will be dispensed this year, or 1800 per capita. And when you shake it out, when relief is just a swallow away, there are some things you should know.

You should know that if you follow directions, the pill will probably do what it's supposed to--numb you or regulate something or take you up or down or round and round--but that there may be nasty side effects, things your doctor may not have told you because he didn't know or wasn't told by the people who made your pill. You're now licensed to get addicted, twisted, blasted, ruined by accident or on purpose, but altogether legally. Empowered to join Betty Ford, Jerry Lee Lewis and unsung millions of your fellow citizens in becoming dependent on the pills; so much so that in extreme cases, you may find yourself doctor shopping for more prescriptions, or patronizing shady pharmacies, or going onto the street to find pills to feed your habit. You may become one of the 200,000-plus overdosed emergency-room patients, or, if you really abuse your pills (especially taking them with some other drug, such as alcohol), you can wind up dead. Some 10,000 to 12,000 prescription-drug victims will this year (that's exclusive of other drug-related deaths, such as those who will die from allergic reactions to antibiotics).

Say, for example, that you're given something common, one of the 72,424,000 prescriptions for Librium and Valium (both are products of Hoffman-LaRoche, the IBM of pills; 57,084,000 Valium prescriptions were written last year, more than for any other drug. In fact, Valium is in a class all its own, since nearly one and one half times as many prescriptions were written for it as for the number-two prescribed drug in the country, Darvon, a painkiller whose therapeutic use has been questioned, and that carries the danger of dependence and results in numerous fatalities each year). You'll get about 50 tablets in an ordinary Valium prescription. Take too many with another drug and you'll be one of the 63,700 clients of the emergency room. That's three times more Valium O.D.s than there are heroin overdoses in a year. You could be one of the 880 Valium-related deaths. That's more than 50 percent of the heroin total and about twice those attributed to a downer such as phenobarbital.

Or suppose you're given any of the top 24 abused prescription drugs. Then you might join the 280,600 emergency-room visitors or the 10,950 people who died as a result of those drugs. The warning about alcohol cannot be emphasized too strongly: According to law-enforcement officials and chemists, a ten-milligram Valium (good for at least eight hours in a normal adult male) taken with one beer equals 100 milligrams of Valium. You're entering a big, potentially dangerous drug culture, one that can cure you but may control or even kill you. And whose fault is that?

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Actually, the patient is the end (too often literally) of a line tracking through pharmacist and physician to the corporate leviathans of the drug industry. The freight can be heavy on that receiving end and the victims have no profile--they run the gamut from street users to middle-class housewives to the doctors themselves. For example, Marilyn was a pretty 17-year-old high school student in a lower-middle-class urban neighborhood when, like millions of other teenagers, she went looking for pills on which to get high. The local mark was an osteopathic practitioner, fully qualified under the law to prescribe drugs. Marilyn was slender, obviously in fine health, but the osteopath gave her a prescription for amphetamines, anyway. (In this case, for Preludin, an often-abused amphetamine analog.) Marilyn visited her local pharmacist, who was well aware that the osteopath had written many prescriptions for teenagers. She paid him $30 for 25 pills (manufacturing cost, about three dollars; pharmacist's cost, about eight dollars). Soon after she started taking the pills, she was boiling them down and taking the speed intravenously. Today, Marilyn can look back on ten years of addiction to speed. Littering those years are prostitution, robbery, futile drug rehabilitation attempts, jail terms and--ultimately--the murder of her pimp lover. Marilyn is once again out of jail. She is 27 and looks 60. She still takes Preludin, Ritalin, Desbutal, Desoxyn--whatever she can wangle from physicians (osteopaths in Marilyn's city are easier marks than M.D.s). As long as their prescription power is perverted, Marilyn will have lots of company.

Even the well-meaning doctors can, out of ignorance, ruin or kill people, often with drugs no one would take even to get high. Esther Sudell, a chronic sufferer of sinus problems, decided she needed medical attention for headache pain and a stuffed-up nose after her usual acetaminophen dosage did not provide relief. So she went to the nearest hospital. The intern gave her cephalosporin, a compound related to penicillin. What he didn't know was that Mrs. Sudell had a long list of allergic reactions to a variety of things, including penicillin. She was also diabetic. Soon after taking the cephalosporin, she started having trouble breathing. Her husband checked back with the hospital and was told he had nothing to worry about. Gradually, breathing became more and more difficult for Mrs. Sudell, and her husband called the family doctor. He, too, told them not to worry. An hour later, Mrs. Sudell stopped breathing altogether. Another hour later, she was back at the hospital. D.O.A.

Physicians themselves are often victims of their own drugs. Addiction, particularly to narcotics, is frequent enough among doctors to be a major concern of the A.M.A. and the Federal Government. But the doctors' carelessness with drugs can also be lethal. A case sharpens the point. Dr. Parker (a pseudonym) had what he diagnosed as a bacterial respiratory infection. It hampered his work, so he visited a fellow M.D. for an antibiotic injection. Dr. Parker had suffered very mild reactions to some antibiotics, but had thought nothing about them. His friend did not inquire about allergies before injecting him with penicillin. Thirty seconds later, Dr. Parker was unconscious on the floor, traumatized by a severe anaphylactic reaction. His life was saved by his friend's giving him an immediate injection of Adrenalin and prompt care at a nearby hospital. Dr. Parker was lucky--such services are not always available--but he still wishes his friend had been more careful.

The most frequent problem drug user is typified by a man we'll call Gerry Luther, aged 35, married, with three children, an insurance agent, active in the Jaycees and the high school boosters club, a jogger.

His work depressed him. It also wound him up tight. Gerry got prescriptions first for Valium. For months, it helped get him through his workday. Then he found that mixing it with vodka or an occasional joint gave him "very good feelings." He started doing lots of it. But his work, his middle-class life still depressed him. From another doctor, he got a prescription for Elavil, an antidepressant. Mixing and matching his various potions, Gerry discovered he could get positively euphoric--and stay that way with constant and unchecked prescription refills. Work, family became interludes for him, but he successfully concealed his drug habit until it became too much even for him to handle.

Luther went to yet another doctor and told him his drug history. The doctor put Luther in an outpatient drug-abuse program. Fortunately, it worked and Luther is now free of drug dependence. He says, "I sure wasn't the only one. I met dozens of people who were flying high every day just to get through it. There's a whole world of them out there."

And if you spend any time asking doctors about cases like these, they will make your hair stand up detailing all of the bizarre and needless ways in which the disease can turn out to be mild compared with the treatment.

So it is certain that each station on (continued on page 178) Gray-Flannel Pusher (continued from page 166) the way to the user or patient bears some responsibility for the overuse, misuse and just plain abuse of the drugs. But the majority of the blame for the prescription-drug culture seems to lie with drug manufacturers. They invent and wholesale each compound. They create its market for doctors, pharmacists and ultimately patients. Their history in developing and promoting drugs is, in some instances, as questionable as it is profitable. True, that doesn't exonerate the other pushers and abusers. Studies show that from one quarter to one half of the people don't take their medicine as prescribed, some through ignorance, many because they like getting high legally. Too many doctors overprescribe ("Let's make the patient feel good, no matter what") and fail to check their patients' progress with the drugs. They, too, may be ignorant of a drug's possible dangers. It's reliably estimated that your physician chooses to get 70 percent of his information on drugs from the drug companies. Most of their data is accurate but it's almost invariably slanted to a particular product. The doctor's journals have better data, but only about 20 percent of his knowledge comes from them.

Thus, they may prescribe too much too often. They frequently prescribe irrationally; amphetamines, for example, for appetite suppression. Today's data shows no valid medical uses for speed except in treating narcolepsy and some rare types of hyperactivity in children. (You will note in our drug chart that weight control and combating fatigue are listed as medical uses of speed. That is because, though strongly discouraged, some doctors still prescribe amphetamines for weight control and because the military uses speed to fend off fatigue.) Perhaps understandably, the physician and the drug company view themselves as partners in fighting disease. The A.M.A. has been muy simpatico with drug companies, which rent lavish display space at A.M.A. conventions, where they buttonhole the prescribers, wining and dining them while extolling their products. The Journal of the American Medical Association is thick with drug-company ads, some of them for products that have been shown to be ineffective or just plain dangerous.

Behind all these problems are the manufacture, distribution and prescription of the drugs in much the same way that Procter & Gamble works to move soap, foods and paper goods. With differences, of course. Some drugs are essential to our well-being. Many are potentially hazardous. All are expensive to develop, costing anywhere (the companies say) from $15,000,000 to $30,000,000 each to perfect. But there are some 21,000 drugs made by these companies, while the World Health Organization claims that only 150 to 200 drugs are needed to take care of almost all ordinary illnesses around the world--figures that leave room at the top for those drugs that might treat exotic conditions. This raises the question: What are they doing making and then pushing all these drugs? The manufacturers find themselves with a large business dilemma. How, on the one hand, to make money for the stockholders (which means generating increased drug usage) and, on the other, to stay ethical (that is, not addle the minds of the medical profession and its patients).

It's estimated that world-wide drug sales are over 40 billion dollars annually. Over one quarter of that comes from the United States, where the companies charge more for most drugs. Here are some examples from 1970 of outrageous profit margins. Minor tranquilizers are a major part of the prescription-drug profit picture: It is estimated today that 27 percent of American men and 42 percent of American women have used them. In 1970, Carter-Wallace, Inc., the holder of the meprobamate patents (Miltown and Equanil), charged domestic drug wholesalers $3.60 for 50 milligram tablets. The pills cost Carter-Wallace only 37 cents, because the active ingredient, meprobamate, is cheap. In addition, Carter-Wallace didn't even make the chemical--it bought it for 87 cents a pound, rolled some into its pills with its name on them and sold the rest in bulk for $23.80 per pound (that's a 2635 percent profit). It was all perfectly legal under patent protection. Patent law gives a company a 17-year monopoly on a drug. It also shows how marketing by brand name is vital to profits.

Another case originated in England, where Hoffman-LaRoche was selling Valium for $2300 per kilogram to the British Health Service. The cost was $50. The British government found out and forced LaRoche to return some of the overcharge. The price of Valium went down dramatically in England, but LaRoche didn't alter its prices elsewhere. Americans today pay three to four times what the English do for this brand name.

Hoffman-LaRoche is one of the world's most profitable companies. Indeed, Hoffman-LaRoche "is drugs," as one pharmacologist said, the model for the industry. It is a Swiss-based firm controlled by a small group of stockholders. Their profits are secret but are known to be astronomical. An analyst for the Bache brokerage house said, "Dealing with Swiss drug companies is like dealing with Swiss banks." Shares of the company are not traded openly. They are tightly held by their owners, for very good reason: One share is estimated to be worth between $40,000 and $60,000. Hoffman-LaRoche's American subsidiary, Roche, contributes 40 percent of total world-wide sales. Roche has more prescriptions among the top 200 drugs than any other company. It is estimated that those prescriptions account for 81 percent of all prescriptions. Discussing a possible take-over bid by Americans, the chairman of Hoffman-LaRoche himself once admitted, "It would require a sum of money that could not be raised by very many institutions in the world, even in the U. S. General Motors might be able to manage it, but nobody else." In short, Hoffman-LaRoche is a gold mine. Valium, in fact, is worth more than gold. It's over $1000 per troy ounce, while gold is a mere $185 at present.

Clearly, the drug business commands staggering profits and not just for Hoffman-LaRoche. As a group, American drug companies average 18 percent profit on invested capital (despite substantial research costs). That is almost twice the profit of manufacturers in other fields.

How do they do it? By promoting the pill culture and, particularly, by influencing physicians--and, to a lesser degree, pharmacists--to prescribe their products by brand name. The chemical compounds themselves, prescribed by genera, are cheap, ranging from six to as much as 35 times cheaper than their brand-name equivalents. They're not nearly as profitable, though most drug manufacturers make and sell the generic compounds (some companies even make and label their competitors' products). Indeed, as we've seen, many manufacturers buy the chemicals from small makers, slap their brand on them, jack up the price and send out the salesmen.

There's the rub: the promotion of drugs. U. S. drug companies spent an estimated 1.3 billion dollars, almost 13 percent of their sales, promoting their brands last year. They spent nine or ten percent on research, in a business that drug-company officials call "research intensive." Put bluntly, their promotion is wildly out of proportion to their business.

Their sales representatives, called detail men because they give the doctors details about drugs, number almost 24,000. Most are well informed about their line, though their training period can be as short as two weeks. Most try to be fair about the details but, as one doctor put it, "In some cases the information is misleading. Even if it's good, it's weighted toward their product." Their targets of opportunity: physicians and pharmacists, those who control the patients and whom, in turn, the drug companies would like to control, or at least influence. There are about 350,000 doctors in the U. S. and the drug companies each year spend an average of $3500 per physician promoting the drugs, 70 percent through the detail men, the rest through such things as ads in professional journals. The companies bring a lot of pressure to bear and in promoting the drug culture, they run afoul of a vexing ethical paradox. Part of a doctor's responsibility is limiting his patient's drugs to those actually and sorely needed. But despite their good work in inventing the drug, and despite their basic commitment to health, it is the drug companies' mandate--for business reasons--to pervert the doctor's responsibility: to get him to push more pills.

The means used to manipulate the physician and the pharmacist illustrate how, until recently, the big pushers leaned on ethical issues. (Circa 1974, some of the following practices were somewhat curbed, due to the Senate investigation of the drug industry by Gaylord Nelson, the industry's longtime nemesis, and Edward Kennedy, whose interest in national health is well known.)

The manufacturers' basic promotional device was unlimited sampling. A detail man (whose average visit in a doctor's office was then and is now five minutes) would breeze in, say what the drug was good for (sometimes neglecting the side effects) and drop a load of pills onto the physician's desk. An investigator for Senator Kennedy's staff estimated that three billion pills were sampled in 1974, or more than 8500 to every doctor in the country. Many were given to patients by the doctors, free of charge. A few physicians sold them to pharmacists, who, in turn, sold them again. Some doctors simply exchanged them for drugstore sundries such as tooth paste. In rare cases, they even sold them to their patients. However dispensed, the pills found their way to the public and, more importantly, to the physicians' repertory of brand-name "drugs of choice" (meaning the best, meaning the most familiar). Some drug companies gave samples to nurses and receptionists, too, along with "reminder items" such as pens, pencils, memo pads, perfume, various baubles. The pressure was clever and relentless.

Supermarket-style promotions were invented, especially to take advantage of fast-breaking opportunities in the drug game. Pfizer, Inc., once wanted to sock its Diplovax polio vaccine to the physicians in advance of a Governmental campaign to increase polio immunization, so it offered doctors premiums. They got books for ordering 100 doses, tape recorders for 250, calculators for 500 and the biggie, an upright freezer, for 1000. Other companies offered doctors "points" for prescriptions, leading to watches, travel, sporting goods, luggage, tools--any prize the heart desired. This 1974 Pfizer exhortation to the detail men exemplifies the company's marketing mentality: "Up to Your Ears in R.D.P. Sales. Wow! What a fantastic start! In the first full month of implementation, the dynamic Pfizer Labs field force turned in a spectacular 2230 R.D.P. [Retailer Dividends Program] deals totaling $675,000!" The detail men kept coming, as they still do, and the process recycled. The companies offered "symposia" (in actuality, expense-paid public-relations fiestas) to promote their products under the guise of learned gatherings.

Many doctors were already accustomed to this. As medical students, they had been offered tours of Eli Lilly and other companies. They were also given medical bags, stethoscopes, percussion hammers, plenty of expensive equipment and lots of leaflets. Companies would also provide handy preprinted prescription pads for the doctors, their brands neatly specified, all ready for the doctors' signatures. To check on how the massive promotion campaign was working, the detail men prevailed on friendly pharmacists to open their prescription records, violating the patients' right to confidentiality. With a "scrip survey," the detail men would check brands that doctors were prescribing. Then they could encourage or discourage their habits. For this help, the pharmacists got more favors.

Advertising reinforced the fundamental detail-man marketing approach. To help make a brand a household word in the doctor's office, the companies ran, and to this day run, hard-sell ads that, in the words of one pharmacologist, "imply and insinuate as much as possible about how this drug is superior, a cure-all, and still get away with it under the FDA." During the Sixties, for example, Roche spent an estimated $200,000,000 pushing Librium and Valium. Some ads showed tense college students, harried housewives and tired businessmen, instead of the genuinely neurotic patients for whom the tranquilizers had been developed. As John Pekkanen's book The American Connection puts it, "The whole campaign of the drug industry for mood drugs in the Sixties was to broaden to absurd limits the definition of illness to include every upset, every disappointment and every vague problem encountered in normal day-to-day living.

Current Valium ads feature the slogan "For the response you know, want and trust," adding, "A response which brings a calmer frame of mind." A current Pfizer ad for Sinequan, a powerful mood-altering drug used for depression, shows a housewife's hand cleaning a hazed-over window with a rag, revealing a beautiful sunrise over a lake punctuated by a forested island and mountainous terrain in the background. The dramatic headline reads: "Clearing of Depression." How is the doctor to interpret this? The ad doesn't exactly say, though it gives all the information required by law (if the physician has the time to read the fine print). Our interpretation would be that Pfizer is saying that perhaps more housewives than you think need Sinequan. That perhaps Pfizer has overstated its case. In short, the companies' samples, ads and other marketing methods are intended to create a drug-dependent society, and one dependent on brands.

It has worked. Last year, 90 percent of all prescriptions were given by brand name rather than by genus. Dr. Ralph Kauffman, a former FDA pharmacologist, now at the University of Kansas Medical Center, expressed it this way: "The promotion system encouraged doctors to overprescribe certain brands. If all of them had [followed the detail man's lead], then we'd really have had gross overprescribing. Consumers just expect a pill for every symptom in this culture."

The culture has shown some strange symptoms, indeed, from the pill pushing, as a few examples show:

• Premarin, a hormonal compound from Ayerst was designed to alleviate menopausal suffering. In a single year, it was prescribed more often than there were menopausal women in the nation, often with irksome side effects such as vaginal bleeding and odd hair growth. (Note: Some of those prescriptions may be accounted for by the drug's use in postmenopausal and/or posthysterectomy women, for whom the drug suppresses some ill effects.)

• Darvon, Eli Lilly's questionable painkiller, addicts thousands. This synthetic opiate is now the number-one overdose killer in Oregon.

• Talwin, a potent synthetic narcotic from Winthrop Laboratories, has such large-scale street use that a Midwest psychiatric institute estimates as many as 24 percent of heroin addicts also use (continued on page 226) Gray-Flannel Pusher (continued from page 180) it. Some people are addicted exclusively to Talwin, which some studies suggest causes muscle-cell decomposition.

• Before Congress restricted their manufacture and prescription in 1971, amphetamines were the most abused and overprescribed drugs in the country. Smith, Kline and French and other companies aggressively promoted speed as good for obesity, "apathy, pessimism, loss of interest and initiative and lack of ability to concentrate." Moreover, the manufacturers ignored the threat of paranoid psychosis resulting from speed addiction, preferring to note side effects such as infrequent and mild "insomnia, excitability and motor activity." Street use grew alarmingly in the Sixties, as did quasi-legal use by legions of Dr. Feelgoods and by the so-called fat clinics. Smith, Kline and French was called "The House That Speed Built," because it held the first U. S. amphetamine patents.

Today, especially in combination, amphetamines are still widely abused, and still marketed aggressively, if quietly. Biphetamine (the 20-mg. "black beauties" are a widely sought-after Pennwalt speed cocktail), Ritalin, Preludin, Dexamyl, Desoxyn and their chemical cousins tangle up thousands of housewives, business people, students, athletes and ordinary street users.

Some druggists and doctors have been known to deal these drugs. The prototypal Dr. Feelgood epitomized the abuses perpetrated by unscrupulous or careless doctors. He allegedly shot up his very distinguished clientele with a miraculous preparation of vitamins and amphetamines. The folks sure felt better, but many became addicts. Some sources have even said that at least one large American drug company manufactures amphetamine (or its ingredients) in bulk, ships it legally to Mexican factories, where it's rolled into pills, then smuggled back for illegal use. It seems we just can't get along without the speed we learned to love in the Sixties. As a Pennwalt sales memo said in 1971: "Project Number One. Increased share of anti-obesity market. Continuous and vigorous marketing of Biphetamine, Biphetamine-T and Ionamin."

• Panalba, a combination of two antibiotics, was introduced and promoted by Upjohn, even though it was described by Senator Nelson as a "classic case of the common practice of creating a new entity with a new trade name, even though it served no medical purpose." The compound was eventually found to be no more effective than a single antibiotic. Along the way, it had killed a few people.

• Chloromycetin, an antibiotic from Parke-Davis, was introduced in 1948 and promoted as good for a variety of infections. Two years later, it was found to cause fatal bone-marrow poisoning in some patients. Later, it was found to be effective against only Rocky Mountain spotted fever, typhoid fever and one strain of meningitis. All are diseases to be treated in the hospital, yet in 1976, over half a million prescriptions were written for the drug, half of them for people not in the hospital, two thirds of them for inappropriate diseases.

When Nelson began his long-running commitment to new laws for the drug industry, it was due to such eccentricities and to related questions.

Patents: Why should one company have a monopoly for so long? Profits: Why are they allowed to remain so high when only nine or ten percent of the money goes to research? Promotion: Why so many drugs? Why try to make us all so drug dependent? This cause was taken up by Senator Kennedy a few years ago. The Drug Regulation Reform Act of 1978 would try to address these and other questions. The bill would give the Secretary of Health, Education and Welfare and the FDA the authority to remove suspicious drugs from the market without the current lengthy review procedure. It would require postmarketing surveillance of the drugs by their makers, to spot any possible side effects that hadn't been noticed before--a very important point, given past misadventures. In addition, the raw data generated while testing the drug (including clinical trials), which the companies now share with the FDA, would finally be available to the public, opening the drug companies to increased competition. The measure would not affect the 17-year patent monopoly. However, it would require pharmacies to post prices for their brand-name drugs compared with the generic substitutes and provide clear information with each prescription drug.

The Pharmaceutical Manufacturers' Association, the lobbying arm of the industry, opposes large chunks of this act. The companies claim that disclosing their research results would end basic research, since competitors would steal their hard-earned compound. The patent also protects their property rights. They contend that the FDA is now so strict that there is a "drug lag," that good drugs are in use in Europe that the FDA forbids here, and the end of research would worsen it. Furthermore, the industry claims that it stopped its promotion abuses voluntarily in 1974 and says that developing new drugs must not be impeded (provided, one assumes, that a new disease is discovered to match the drug--otherwise, the companies would do better marketing the diseases).

What about promotion today? Product information? Research? Side effects? The number of necessary drugs? Patents vs. shorter-term licenses? Profits?

Some detail men report that the 1974 voluntary restraints have stopped unlimited distribution of samples to physicians, that now the doctors must request the drugs in writing. But Kennedy's investigators report that one and a half billion pills are still being sampled. And the unsolicited sampling goes on, according to several detail men. One described the new method: "What we say now is, 'Can I leave six bottles with you? Fine, sign this, please.' Or we have the nurse sign."

The reminder items still abound and many doctors write their prescriptions with the drug company's pen. As for gimmicks, Senate sleuths report that contests are out, the number of come-ons is down, but the amount spent on PR activities has stayed the same proportionately. And as the FDA and Congress debate control of promotion, the companies are shifting their marketing focus. A detail man for one of the top drug companies in America said, "The real marketing now is to the pharmacist. Somebody's always got a deal, a promotion, so now we go to the pharmacist and say, 'Buy these, you can substitute for what the doctor orders.' Then we throw in a trunkful of samples. We call it trunking. Some guys, especially detailing for little companies, will do anything to keep butter on the table."

His comments raise other issues. Many states have recently passed laws allowing pharmacists to substitute generic drugs for those brand names the doctor prescribes. Trunking could allow a more sinister substitution of one brand for another, irrespective of possible subtle chemical differences and side effects. (Not incidentally, the passage of substitution laws, deplored by the companies actually represents a substantial opportunity for them in selling their generic equivalents.)

It takes an average of five visits to sell a practicing doctor on a brand. To get the doctor early, the pharmaceutical makers send their detail men into hospitals to pitch interns and residents. A sales representative said, "It's good. I've got real control and PR for my company. Those guys don't know much about drugs, they've had only six months of pharmacology." Medical schools, it must be said, now require more pharmacology.

The drug manufacturers' clout extends even to their regular, the FDA. Under current law, when a new drug is developed, the manufacturer gets permission from the FDA to test it. Yes, the drug company hires the testers. The FDA merely evaluates the summary of results and decides whether or not to permit the selling of the drug. Several problems for the eventual patient pertain. It's often been alleged that the companies have lobbied those responsible for evaluating their products, so that the manufacturers in effect have regulated their regulators. Many FDA staffers have left the agency to go with drug companies, and vice versa.

Three years ago, an honest FDA inspector was checking research data on a drug called Flagyl marketed by the mammoth G. D. Searle & Co. The drug treated vaginal and urinary-tract infections and had been widely prescribed since its introduction in 1949. Searle had vowed that its research data showed the drug was absolutely safe, but the FDA investigator dug deeper, smelling a rat. She found 38 of them dead of cancer, raising serious questions about Flagyl's toxicity. The inspector reported her suspicions and suddenly was persona non grata with her bosses at the FDA, who seemed most anxious to keep her cancer-agent report under wraps. Eventually, Kennedy's subcommittee heard the inspector's complaint and an investigation was launched. Still, the upper-echelon FDA officials refused to divulge what Searle had told them--or what the true test results were--under a provision of the current drug law that that protected drug-company "trade secrets." There have been numerous such research disasters. Remember the near miss with Thalidomide?

So pervasive is the interlocking of regulator and regulated that HEW Secretary Joseph Califano, Jr., once lobbied for the Hoffman-LaRoche cause when he was a Washington attorney. Califano is credited with influencing Congressmen to put Valium and Librium on a separate schedule (a list of dangerous substances to be controlled by Federal regulation) from amphetamines and barbiturates, when the uppers and downers were the subject of legislation. Califano in his new position would be the one to implement the new Drug Regulation Reform Act if it became reality.

The pharmaceutical industry has a point, though, about the proposed forced disclosure of raw test data. That could destroy the incentive for innovative research by giving the second comer in the business free access to your work. But whether it would accentuate the drug lag by repressing new products is questionable--as questionable as whether or not a lag exists. It's true that from 1971 to 1976, three times more new drugs were introduced in England than in America, proof, the companies say, that FDA regulations are already too strict. In 1959, for instance, 63 new drugs were introduced in America, versus 16 in 1970, but the Sixties marked a great crest of medical discoveries.

The FDA claims there is no drug leg, that Americans have the pills they need in spades and that as new drugs are developed, they will under the law be more speedily tested and sold.

Patents and profits? Expiring patents do mean the possibility of slowed profits. A lapsed patent frees other manufacturers to make that particular compound and sell it. But usually, the original producer continues to hold the bulk of the market--and might if the law specified five years instead of the 17 provided by patent--because people have developed a habit for that drug. The loss of Librium's patent hasn't hurt Hoffman-LaRoche, and when Valium's is up in 1980 . . . well, the chairman of Hoffman-LaRoche has said, "When it expires, we hope to find some way to keep profitable." It shouldn't be hard. First, there's some evidence that the large companies price-fix, though drug-company officials deny it. They will not say, however, how their prices are set. On the few occasions when companies voluntarily allowed Federal investigators to examine their books, nothing was found--perhaps because the companies had ensured that nothing would be found. Recently, however, the Seventh Circuit Court has ruled that the General Accounting Office can inspect all of Eli Lilly's books. The result might be interesting. The second reason for the companies' astonishing profits is more telling. We need drugs.

The ultimate question is whether or not we need as many drugs, in such quantities. The past few years, the number of prescriptions has been going down, perhaps a hopeful sign for those who would like to loosen the drug culture's grip on America. The trouble with that fact is that doctors are prescribing more pills per prescription. They may be saving the patient the cost of another visit, but there is also the possibility that the doctors, like the pharmacists and the rest of us, have become dependent on the idea of the drug culture and on its pushers, the manufacturers. So? Relax! Take a pill. Or if all this has made you listless, logy, half-alive, pop something peppy.

Last spring, there was an ad from speed producer Pennwalt. It read, "We want our competitive enterprise system to survive. Because we're part of it. And because we've prospered within the system." Yeah, and don't forget, while you're reading, speeding, downing and twisting--if you're between 18 and 25, the chances are one in four that you've abused a prescription drug--there's a detail man out there, on orders from his government. You'd better pray he's not like the one--an exception--who said, "Sometimes I'm talking over my head. I'll come out and wonder what I said in there." If he wonders, maybe you ought to ask the doctor what's on that paper he's holding out. Maybe it's Latin for: Some people will swallow anything.

"Only 150 to 200 drugs are needed to take care of almost all ordinary illnesses around the world."