Page 48 of Strong Medicine


  The word golden was appropriate. As Fortune magazine headlined a feature article a year after the new drug swept, like a tornado, upon the pharmaceutical scene:

  FELDING-ROTH

  FINDS RICH

  IS BETTER

  Fortune estimated that the first year of Peptide 7 sales would bring in revenues of six hundred million dollars. That and earlier estimates caused Felding-Roth shares, traded on the New York Stock Exchange, to go, in one broker’s words, “through the roof into the stratosphere.” Immediately after the drug’s introduction the share price tripled in a month, doubled again within a year, and redoubled during the eight months following. After that, directors voted for a five-to-one split to keep the share price within a reasonable trading range.

  Even so, when accountants finished their arithmetic, the Fortune estimate proved low by a hundred million dollars.

  Something else Fortune said was, “Not since SmithKline’s remarkable ulcer drug, Tagamet, was introduced in 1976 has there been any industrial product comparable with the phenomenon of Peptide 7.”

  The success was not confined to money.

  Thousands upon thousands of middle-aged and elderly men and women were taking the drug, spraying it into nasal passages twice daily and proclaiming that they felt better, their memories were sharper, their general vigor enhanced. When asked if “vigor” included sexual energy, some replied frankly, yes, while others smiled, declaring that to be a private matter.

  The enhanced memory factor was regarded by medical experts as the most important. People taking Peptide 7 who once suffered from forgetfulness now remembered things. Many who previously had difficulty in recalling other people’s names found that problem disappearing. Telephone numbers were recollected without effort. Husbands who formerly forgot them began remembering their wives’ birthdays and wedding anniversaries. One elderly gentleman claimed to have memorized, without even trying, an entire local bus schedule. When put to the test by friends, he proved it true. Psychologists who devised “before and after” memory checks confirmed to their satisfaction that Peptide 7 worked.

  Though considered secondary to memory, the drug’s antiobesity effect quickly became indisputable and advantageous. Fat people, including those in lower age groups, lost unwanted weight and gained in general health. The effect was soon so widely accepted medically that Felding-Roth applied, in the United States, Britain and Canada, for an official weight-loss “indication” to be added to Peptide 7’s authorized use. There seemed little doubt the applications would be approved.

  Throughout the world, other countries were rushing to approve Peptide 7 and obtain supplies.

  It was too early yet to know whether the drug would reduce the incidence of Alzheimer’s disease. Such knowledge was several years away, but many lived in hope.

  One critical question was being asked. Was Peptide 7 being over-prescribed, as had happened with other medications in the past? The answer: almost certainly, yes. Yet what made Peptide 7 different from those others was that even when not needed, it did no harm. It was not addicting. Incredibly, adverse reports about its effects were almost nil.

  One woman wrote from Texas, complaining that each time she took a dose, and afterward had sexual intercourse, she ended with a headache. The report was passed routinely by Felding-Roth to the FDA, and also investigated. The matter was dropped when it was discovered the woman’s age was eighty-two.

  A California man went to Small Claims Court, demanding that Felding-Roth be made to pay for a new wardrobe since his previous clothes were no longer usable after Peptide 7 caused him to lose thirty pounds of weight. The claim was contested and dismissed.

  Nothing more serious was reported.

  As for doctors, their enthusiasm seemed to have no limits. They recommended Peptide 7 to patients as being beneficial, safe, and one of history’s great medical advances. Hospitals were using it. Doctors who enjoyed active social lives rarely went out to dinner or to a cocktail party without a prescription pad in pocket, knowing they would be asked for Peptide 7, and that obliging a host or hostess, or their friends, could lead to other invitations.

  On the subject of doctors, Celia said to Andrew, “For once you were wrong. Doctors weren’t put off by all that publicity. In fact, it seems to have helped.”

  “Yes, I was wrong,” her husband admitted, “and you’ll probably remind me of it for the rest of my life. But I’m happy to be wrong, and happiest of all for you, my love. You—and Martin, of course—deserve everything that’s come about.”

  The publicity seemed to continue unabated, perhaps, Celia thought, because Peptide 7 was causing so much renewal of human happiness. In newspapers there were frequent references to the drug’s effects, and on television it was talked about often.

  Bill Ingram reminded Celia, “You once told me the nature of TV would help us one day. It certainly has.”

  Ingram, who had been promoted a year earlier to executive vice president, was carrying much of the load that Celia formerly had. Celia’s main preoccupation nowadays was what to do with the money that was pouring in and, presumably, would continue to accumulate for years to come.

  Seth Feingold, now retired, had been retained as a consultant and appeared occasionally. During one meeting with Celia, a year and a half after Peptide 7’s U.S. introduction, Seth cautioned, “You have to speed up decisions about how to spend some of that cash. If you don’t, too much will be swallowed by taxes.”

  One way of using cash was to acquire other companies. On Celia’s urging, the board approved purchasing the Chicago firm which was making Peptide 7’s containers. That was followed by acquisition of an Arizona concern specializing in new drug delivery systems. Negotiations to buy an optical company were under way. Many more millions would be spent on a new genetic engineering research center. There would be expansions overseas.

  A new company headquarters was planned, since the existing Boonton building had run out of space and some departments were housed in distant, rented quarters. The new structure would be in Morristown, with a hotel as part of a Felding-Roth high-rise complex.

  One purchase was a jet airplane—a Gulfstream III. Celia and Ingram used it on their North American journeyings, more frequent now because of the company’s widening activities.

  During Celia’s meeting with Seth, he also said quietly, “One thing that’s good about all this money coming in is that some of it can be used to settle claims about those poor Montayne-deformed children.”

  “I’m glad of that too,” Celia said. She had been aware for some time that the existing reserve fund being used by Childers Quentin for Montayne settlements was almost exhausted.

  Seth said sadly, “I’ll never feel free from my guilt about Montayne. Never.”

  Sharing the sober, reflective moment, Celia thought: Amid an enormous therapeutic and financial success, it was necessary and chastening to be reminded that grim failures were also part of pharmaceutical history.

  Through all of Peptide 7’s bountiful triumph, Martin Peat-Smith was, as the cliché went, in seventh heaven. Not even in the most optimistic moments had he ever imagined so much would be accomplished by his research into aging. Martin’s name was now widely known, his person admired, respected and in demand. Praise and accolades poured in. He had been elected a member of the Royal Society, Britain’s oldest scientific body. Other learned societies sought him as a speaker. There was talk of a future Nobel. A knighthood was rumored.

  Amid the attention, Martin managed to retain some privacy. His home telephone number was changed and unlisted. At the institute, Nigel Bentley arranged for Martin to be shielded from all but the most important calls and visitors. Even so, it was clear that Martin’s earlier, inconspicuous life would never be the same again.

  Something else changed too. Yvonne decided to cease living with Martin, and to move into a flat in Cambridge.

  There was no quarrel or difficulty between them. It was simply that she resolved, quietly and calmly, to go her sep
arate way. Recently Martin had been away from Harlow a good deal, leaving her alone, and at such times it seemed pointless to make the daily two-way Harlow-Cambridge journey. When Yvonne explained her reasoning, Martin accepted it uncritically, with understanding. She had expected him to put up at least a token argument, but when he failed to do so, she did not show her disappointment. They agreed they would see each other occasionally and remain good friends.

  Only Yvonne, when the moment came to leave, knew how sad, how torn she was inside. She reminded herself how happy she was with her veterinary studies; her third year had just begun.

  Immediately following the separation, Martin was away for a week. When he returned, it was to a darkened, empty house. It was more than five years since it had been that way, and he didn’t like it. He liked it even less as another week passed. He found that he was lonely and missed the sight and cheerful chatter of Yvonne. It was, he thought on going to bed one night, as if a light in his life had abruptly gone out.

  Next day, Celia telephoned from New Jersey on a business matter and, near the end of their conversation, observed, “Martin, you sound depressed. Is anything wrong?” It was then, in a burst of confidence, that he told her about missing Yvonne.

  “I don’t understand this,” Celia said. “Why did you let her go?”

  “It wasn’t a question of letting her. She’s free, and she decided.”

  “Did you try to talk her out of it?”

  “No.”

  “Why not?”

  “It didn’t seem fair,” Martin said. “She has her own life to live.”

  Celia agreed, “Yes, she does. And she undoubtedly wants more out of it than you were giving her. Did you consider offering her something more—like asking her to marry you?”

  “As a matter of fact, I did consider it. The day Yvonne left. But I didn’t, because it seemed …”

  “Oh, God help us!” Celia’s voice rose. “Martin Peat-Smith, if I were over there I’d shake you. How can anyone bright enough to find Peptide 7 be so dumb? You fool! She loves you.”

  Martin said doubtfully, “How do you know?”

  “Because I’m a woman. Because I hadn’t been five minutes in her company before it was as plain to me as it’s plain now that you are being obtuse.”

  There was a silence, then Celia asked, “What are you going to do?”

  “If it isn’t too late … I will ask her to marry me.”

  “How will you do it?”

  He hesitated. “Well, I suppose I could phone.”

  “Martin,” Celia said, “I am your superior officer in this company, and I am ordering you to leave that office you are in, right now, and get in your car, and drive to find Yvonne wherever she is. What you do after that is your affair, but I’d advise you to get down on your knees, if necessary, and tell her you love her. The reason I’m telling you this is that I doubt whether, in all your future life, you’ll find anyone who’s better for you, or who’ll love you more. And, oh yes, you might consider stopping on the way to buy some flowers. At least you know about flowers; I remember you sent some once to me.”

  Moments later, several employees in the Harlow institute were startled to see the director, Dr. Peat-Smith, running full tilt down a corridor, racing through the outer lobby, then jumping in his car and speeding away.

  The wedding present from Celia and Andrew to Martin and Yvonne was an engraved silver tray on which Celia had included lines from To a Bride by the Essex-born seventeenth-century poet Francis Quarles:

  Let all thy joys be as the month of May,

  And all thy days be as a marriage day:

  Let sorrow, sickness, and a troubled mind

  Be stranger to thee.

  And then there was Hexin W.

  It was due to appear on the market in a year.

  18

  The clinical trials of Hexin W produced a few side effects in patients who had taken the drug in conjunction with other chosen drugs—such combinations being the route to effective medication via the quenching of free radicals. There were scattered reports of nausea and vomiting, and separate occurrences of diarrhea, dizziness or elevated blood pressure. None of this was unusual or a cause for alarm. The incidents were not severe, nor did they appear in more than a tiny percentage of patients. It was rare for any drug to be free from occasional side effects. Peptide 7 had been a notable exception.

  The Hexin W trials, which occupied two and a half years, were overseen personally by Dr. Vincent Lord. In doing so he handed over other responsibilities to subordinates, leaving himself free for what had become a task of total dedication. At this vital, near-final stage he wanted nothing to go wrong with the launching of his brainchild. Nothing which, through someone else’s neglect or inefficiency, might diminish his scientific glory.

  Lord had watched with mixed feelings the enormous, continuing success of Peptide 7. On the one hand he experienced some jealousy of Martin Peat-Smith. But on the other, Felding-Roth was now a stronger company because of Peptide 7, and thus better equipped to handle another product that looked as if it could be equally, or even more, successful.

  Results from the Hexin W trials had delighted Lord. No major adverse side effect appeared. Those minor ones which did were either controllable, or unimportant in relation to the drug’s positive, excellent uses.

  In what was known as Phase III testing, where the medication was given to patients who were ill, under conditions similar to those foreseen for later use, the outcome had been uniformly good. The drug had been taken, over substantial periods of time, by more than six thousand persons, many in hospitals under controlled conditions—an ideal setup for test purposes.

  Six thousand was a larger number than in most Phase III’s, but was decided on because of the need to study Hexin W’s effects when taken with various other drugs, hitherto unsafe.

  Arthritis patients, as had been hoped, responded particularly well. They were able to take Hexin W not only alone, but with other strong anti-inflammatory drugs that formerly had been denied them.

  Coordinating the testing, in several widely separated locations, had been a mammoth task for which extra help had been recruited, both inside the company and out. But now it was done. Enormous amounts of data were assembled at Felding-Roth headquarters and, before submitting it to the FDA in the form of a new drug application, Lord was reviewing as much of the material as he could.

  Because of his personal interest, he found the process mostly a pleasure. Yet, suddenly, it ceased to be when he encountered one set of case reports.

  What Vince Lord read, then reread more carefully, at first caused him concern, after that perplexity, and eventually blazing anger.

  The reports in question were from a Dr. Yaminer who practiced medicine in Phoenix, Arizona. Lord did not know Yaminer personally, though he was familiar with the name and knew a little about the doctor’s background.

  Yaminer was an internist. He had a substantial private practice and held staff appointments at two hospitals. Like many other doctors involved in the Hexin W testing program, he had been employed by Felding-Roth to study the effect of the drug on a group of patients—in his case one hundred. Before such studies began, the patients’ permission had to be obtained, but this was seldom difficult.

  The arrangement was a normal one, used routinely by pharmaceutical companies wishing to field-test new drugs. Yaminer had done work for Felding-Roth before, and for other drug firms too.

  Doctors who contracted to do such work liked the arrangement for one of two reasons, sometimes both. Some were genuinely interested in research. All enjoyed the substantial money it brought in.

  For a little extra labor, spread over several months, a doctor would receive between five hundred and a thousand dollars per patient, the amount varying with the drug company involved and the importance of the medication. For his Hexin W case studies, Yaminer had received eighty-five thousand dollars. A doctor’s own costs for such work were small, therefore most of the money was profit.
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  But the system had a weakness.

  Because the work was so lucrative, a few doctors were tempted to take on more of it than they could properly handle. This led to corner cutting and—with surprising frequency—falsification of data.

  In a word: fraud.

  Dr. Yaminer, Lord was certain, had perpetrated fraud in sending in reports about the effects of Hexin W.

  There were two possibilities as to what had happened. Either Yaminer had failed to do the studies he was supposed to on the patients he had named, or some, perhaps most, of the hundred listed patients did not exist, except in the doctor’s imagination. He had made them up, invented them, as well as their test “results.”

  Making a guess based on experience, Lord believed the second to be true.

  Either way, how did he know?

  One reason—Yaminer had done his fake reporting in a hurry and been careless. What had caught Lord’s eye to begin was a close similarity between the handwriting on patient report forms on different dates. Usually such entries varied, and not only the handwriting, but the writing instrument. Even if a doctor used the same ball-point pen every day, it seldom performed with exact consistency.

  That in itself was not conclusive. Yaminer could have made earlier notes, then transformed them patiently into neater, finished reports. But for a busy doctor it was unlikely. Which prompted Lord to look for more.

  He found it.

  Among tests performed on patients receiving experimental drugs was one to measure urine pH—acidity or alkalinity. For an average person the result would be expressed in the range 5 to 8. But each measurement, on separate days, was an “independent event” and usually varied, meaning that a reading of 4 on Tuesday did not make likely another 4 in the same person on Wednesday. Expressed a different way: over five successive days, the likelihood of pH measurements being identical was only one in four. Long odds.

  Yet, repeatedly, Dr. Yaminer’s reports on patients showed identical pH readings day after day. Highly unlikely, even with one individual. Impossible in the case of fifteen patients—the number reviewed by Lord from the Yaminer study.