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HUMAN TRIALS: Scientists, Investors, and Patients in the Quest for a Cure.

THE VAST MAJORITY OF BOOKS about biotechnology spend endless pages trumpeting the triumphs of genetic medicine and the coming age of wonder drugs. Susan Quinn wants to try something different and instead chronicles the heartbreak of a biotech company that fails, and the dashed hopes of patients in desperate need of its drugs. The result, Human Trials, provides a sobering view of why the search for medical miracles involves enormous risk.

Autoimmune, Inc., was founded in 1988 to develop a new class of drugs for treating autoimmune diseases such as multiple sclerosis (MS), diabetes, and rheumatoid arthritis. Autoimmune disorders are caused by a flaw in the immune system, leading it to mistakenly attack parts of the body. The paralysis and numbness of MS, for instance, results when immune cells destroy myelin, the fibrous sheath that surrounds nerve cells and helps them conduct signals. In rheumatoid arthritis, the immune system methodically annihilates the connective tissue and cartilage in joints. All told, several dozen different autoimmune disorders afflict 8.5 million Americans, a gigantic potential market for the company that can produce a treatment.

Autoimmune's founder was Howard Weiner, a prominent neurologist and researcher at Harvard University who specializes in treating MS patients. Fed up with writing grant proposals that weren't getting funded, Weiner turned to investors to support his research after achieving spectacular results in two experiments in animals demonstrating a theory known as oral tolerance. For each autoimmune disease, the immune system targets a specific set of proteins. In MS, it is proteins found only in myelin; in diabetes, proteins in the pancreas; in rheumatoid arthritis, proteins in cartilage. Weiner reasoned that feeding patients tiny doses of the specific proteins in question might retrain the immune system to tolerate, or grow accustomed to them and stop the attacks. When the idea worked in rodents, Weiner was ready to try oral tolerance on human patients.

So far so good, except that Weiner has hardly a clue how oral tolerance actually works, or at least Quinn fails to explain it adequately, leaving the reader to wonder whether this is just some cockamamie idea cooked up by a bright, but overeager doctor and then marketed ferociously to Wall Street. After all, other biotech companies have been founded on even less science (my personal favorite: Shaman Pharmaceuticals, a company that raised millions for expeditions to search for nostrums used by witch doctors). Oral tolerance, as it happens, is a legitimate theory that may well pan out one day as a treatment for autoimmune diseases, but Autoimmue's investors were destined to lose their shirts.

Before reading this book, I had never thought about how devastating a drug's failure must be to those who have pinned not only their fortunes but also their hopes to it. Quinn describes the moment when Weiner and the officers of the company learn that their drug worked no better than a placebo in patients with MS: "Weiner looked nearly ... shattered ... He sat hunched over the table with a hand on his forehead, as though he didn't want to let people see his eyes. His assessment of the results was brutal. `It was like the feeding of water ... why didn't it work?'"

That is one of the most dramatic moments in the book. Quinn must be the only journalist on the planet who appears not to have a single mean-spirited or skeptical bone in her body. She is so careful not to inject her opinion that the only villain in the story is the immune system. All the human beings come off as well-meaning, sincere, and just so gosh-darned nice. But more important than a lack of drama, Human Trials misses an opportunity to tackle some of the thornier issues surrounding drug development.

Quinn gained unusual access, sitting in on private meetings, interviewing investors, researchers, even patients, whose identities are rarely provided to journalists. Yet when a doctor fails to tell a patient she may be on the placebo in a drug trial, a no-no in the protocol of informed consent, Quinn excuses this by saying the patient has been in so many trials she undoubtedly knows she may be randomly assigned to take the placebo. Maybe. But sick people are generally not so clearheaded when they want desperately to believe that their doctor can help them. That's why there are strict rules for informing patients about the risks of participating in clinical trials, rules that are all too frequently bent or broken when doctors have a vested interest in getting patients to agree to join a drug trial. There is scant mention of the struggle between the openness of academic research and the secrecy of private industry. No issue is made of the conflict of interest created when drug companies pay doctors a bonus for finding patients for clinical trials, or how some doctors can convince themselves they've found a cure before they've bothered to actually test it.

Read Human Trials for a glimpse into the world of clinical trials, but we'll have to wait for insight into the drug industry's darker secrets.

SHANNON BROWNLEE is a freelance science writer in Maryland.
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Author:Brownlee, Shannon
Publication:Washington Monthly
Article Type:Brief Article
Geographic Code:1USA
Date:Jun 1, 2001
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