The Greening Of An Emerald Isle Pharmacologist Par Excellence

Austin Darragh says he's a 'scientific auditor.' Indeed he's made a mint testing many of the drugs in your medicine cabinet. DUBLIN--Austin Darragh is a frequent flier, but only between April and September. Better weather conditions then mean fewer flight delays - and hunting isn't in season. So, during spring and summer he's often on night flights visiting his clients along the U.S. eastern seaboard. "It gives me a kick to see all the twinkling little lights on the streets below," says Darragh. "I think of all the houses with their bathrooms and their little medicine cabinets. And I think: Down there are two things that make me happy tonight. I think of all the drugs down there - helping pain, curing ailments, or making people feel secure - that we had some part in putting there," Darragh pauses in order to emphasize his next thought. "More important," he says quietly, "I am even more relieved by the thousands of drugs we've killed and stopped from getting into the medicine cabinet." If you've taken some medication recently - either of the antihypertensives Vasotec or Capoten, for instance - chances are this Irish pharmacologist who describes himself as "a scientific auditor" has played a role in getting that prescription drug into your medicine cabinet. Darragh, the founder and CEO of the eight-year-old Institute of Clinical Pharmacology (ICP) in Dublin, was one of the first of a growing number of scientists who identified contract clinical research - the testing of new drugs - as a significant entrepreneurial niche. Today, Darragh has helped to create a bonanza market - one valued in excess of $900 million. And he has become, quite possibly, the Emerald Isle's wealthiest citizen. If it's true that Austin Darragh is one of the fathers of the drug testing industry, a profession couldn't have a more respected founder. Darragh is well published with, at last count, 129 scientific papers. He's a departmental director at University College, Dublin, as well as professor of medicine and pharmacology at New York Medical College. He found-ed the Irish Cancer Society in 1964 and is currently its president as well as chairman of the National Council for the Blind in Ireland. But most Irish citizens know him from his radio program as the "Anonymous Doctor," a popular show on health issues. "The guy is buzzing over with enthusiasm. Always ready to go. He's been out there with a type of science expertise, and he's done what a lot of people said he wouldn't be able to do," says Willie O'Brien of Ireland's Industrial Development Authority. And, people will tell you, Darragh has style. Clients are met by a chauffeur driving a Rolls Royce at Dublin airport, and they are treated to traditional Irish hospitality throughout their visit to ICP's headquarters. But rather than flaunting his personal riches, Austin Darragh adds a new dimension to the term understated - he has found out the hard way that wealth is a double-edged sword, making his family vulnerable to danger. In October 1987, his son-in-law was kidnapped by a group of terrorists who were former members of the IRA. After days of tense drama, the gang was captured. But not before they had cut off two of his son-in-law's fingers. Besides work, it is horses, Darragh says, that are his true love. He and his son, Paul, operate a successful horse business; Paul is one of Ireland's top show-jumpers - he represented the country at the Olympics - and Darragh himself was Master of the Meath Hunt for more than a dozen years. He stepped down from this position only recently and, ironically, was seriously injured in a riding accident. "I got a few scratches and bruises in all the years I was Master. But this is the first time I've had a major injury," he muses from his hospital room. "I've learned one lesson from it. It's safer to be a leader than a follower." --K.B. Each year pharmaceutical firms worldwide contract out about 10% of their R&D work to some 200 independent clinical research companies like Darragh's. And, with the FDA's seal of approval on this practice, in the form of guidelines issued in 1987 delineating exactly what responsibilities can be carried out by contract research firms, the practice is picking up significantly. By 1995, the market for ICP and its competitors is expected to exceed $2 billion. Darragh's firm has been one of the most successful to date, with offices in Japan, Switzerland, England, New York, and Nashville, in addition to the corporate headquarters and hospital in Dublin. ICP's clients include 27 of the world's top 30 pharmaceutical firms: Hoffman-La Roche, Du Pont, Abbott, Yamanouchi, and Sandoz, to name a few. And the entrepreneur predicts that by 1995 his firm will control a full 10% of the market, raking in profits in excess of $40 million. ICP also intends to make money from a data management service for drug companies that choose to run their own clinical trials, as well as selling franchises in China and Australia. "Just like McDonalds sells its system for hamburgers, we're doing the same for the standard operating procedures we've developed in our lab," says Darragh. But ICP's bread and butter comes from running clinical trials on new drugs for pharmaceutical clients. These human trials, which must be conducted on every proposed new drug and are initiated only after all animal testing has been completed, are divided into four phases. ICP has developed expertise in all phases of clinical trials, and clients may contract for the whole process, from "white powder to registration," or for specific trials. Though ICP has been performing all phases of trials since its inception in 1980, the firm was the first company to establish a commercial hospital devoted to performing Phase One drug trials. At this hospital in Dublin, healthy volunteers are given doses of a new drug in order to establish how it works within the body, how it is eliminated, and whether it really is safe for humans. Volunteers, on arrival, are given a medical checkup that rivals the NASA surveillance of the early astronauts. Blood and urine samples are run through the lab to see if there are any "chemicals" within the body. (``We do find more traces of cannabis after a long weekend or the Christmas break,'' remarks Edward Caffrey, ICP's general manager.) The presence of even a trace of a chemical substance disqualifies the person. Once a volunteer passes the preliminary checks and is accepted for the trial, he or she is constantly monitored - all bodily functions, including the volunteer's psychological makeup, are carefully tested and assessed. The other, more advanced and less risky phases of testing are performed in a number of cooperating hospitals or doctors' offices and managed by ICP. Phase Two involves trying the drug on actual patients, usually between 25 and 50 of them, to test its efficacy. Phase Three is a wider clinical trial looking at thousands of patients - and the FDA prefers that patients come from at least 10 different sites, in order to get as varied a population sampling as possible. Phase Four, conducted after the drug gets a marketing license, involves at least 10,000 patients and is often performed in conjunction with family doctors. The aim is to gather data in terms of side effects, and how the drug works in a variety of ethnic groups, age groups, and with other prescription drugs. The entire testing process is long and expensive, taking an average of 10 years - and as much as $100 million. So to a drug company, time spent testing is tremendously expensive. "It works out to almost $4 a second for the average drug company," says Darragh, who emphasizes that any delay can dramatically increase cost. "We have proven that because of our standard operating procedures and computerization, we can knock years off the process." Darragh himself is now 62 years old. He has personally been involved in clinical testing for more than 25 years, and, since founding ICP in 1980, he's made more money than he will own up to. Asked if his success is due to a master plan that was formulated decades ago, he laughs: "I didn't consciously set out to be a multimillionaire. I sometimes wish I could say I was a visionary, but the truth is that the things which have happened in the evolution of the business have been circumstance-driven - we have responded to circumstances. "For me as a research scientist I have this little saying." He pulls a small square of white paper from his datebook, puts on his gold-framed Ben Franklin spectacles, and reads: "Do not follow where the path may lead. Go instead to where there is no path and leave a trail." Darragh's boyhood ambition was to become a pilot. But after military service in 1948 at age 21, "medicine seemed to be the least disagreeable of the professions." He did his medical training at Trinity College, Dublin, and subsequently specialized in pharmacology and endocrinology. After a brief obligatory stint as a general practitioner, Darragh went to work for Leo Laboratories, and in 1964 he joined Hoffman-La Roche as the head of its Biological and Medical Research Institute in Ireland, which operated out of prefabs on the grounds of St. James Hospital in Dublin. The big break came in 1980 when Hoffman-La Roche sold its facility to Darragh and became his client. Darragh paid just $300,000 for Hoffman-La Roche's facilities, but today ICP is worth in excess of $100 million. Within four years of its founding, ICP expanded overseas - 40% of its business is now in Japan - and found itself in need of larger facilities, but the Irish banks were unwilling to come up with venture capital. So Darragh was contemplating his next move when, he recalls, "a tall Irish- American walked into my office and suggested I should go public. I said to him `What do you mean, going public?' He was very patient with me, explaining that I could raise money by selling off 20% of ICP in shares on the New York Stock Exchange. And by the end of 1984 we had raised $9 million." The stockbroker who came to ICP's aid was Michael Nally, who had been on the prowl for Irish companies that could be smart investments for his U.S. clients. He'd looked around the clinic with its 110-member staff, computers, and lab technology and told Darragh: "This is the first testing clinic outside of Japan where I have seen five Ph.D.'s being supervised by still another Ph.D. That's the kind of quality control America will buy." In 1986, ICP joined forces with the Hospital Corporation of America, the largest manager of hospitals in the world, which immediately gave ICP a huge patient database for their trials. "It is not possible to guarantee absolute safety on the basis of 5,000 to 10,000 treated patients; the database has to include at least 100,000 patients with two years minimum exposure before we can talk about safety," explains Darragh. "People complain about FDA or other regulatory agency delay. They assume that because the agencies are not commercially driven, they are dragging their feet. But a fair analysis will show that only 10% of the time lost in the life cycle of the development of a drug is due to the regulatory agency. Ninety percent is due to the pharmaceutical industry." But in addition to speed and expertise, it may be smart politically for a drug firm to contract out its clinical research. One senior pharmaceutical executive notes, "It's obvious that a drug company has a vested interest in getting its new drug to market, and regulatory agencies may suspect, if all the research is done by the company itself, that the findings could be slightly biased. If we contract out to an independent research group, that suspicion isn't there. It's like hiring a firm of auditors to do your financial books." Darragh agrees. "We've carved a niche for ourselves as scientific auditors," he says. And it's a niche where, serving medicine and mankind, he is clearly quite comfortable. Karen Birchard is a science writer based in the Republic of Ireland.

The Greening Of An Emerald Isle Pharmacologist Par Excellence

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