Nowhere in this article is there any mention of protecting patients from or informing patients about physicians who may have a financial interest in an ongoing trial; either through investment or because drug manufacturers are paying doctors a fee or ”bounty” for every subject they recruit into the trial. The potential for conflicts of interest and abuse of patient confidentiality in the name of easy returns for doctors and drug companies is enormous with this new initiative. Anyone who doesn’t recognize that is either willfully ignoring how some trials function or stands to make a profit off the new, streamlined method of going into confidential patient records to recruit subjects into trials,

• NEW YORK
• JUNE 17, 2010

New Effort Launched for Clinical Drug Trials

By SHIRLEY S. WANG

New York state medical centers and drug makers are launching an initiative to address a nettlesome problem for clinical drug trials: getting patients to sign up.

More than 3,000 clinical trials are actively recruiting in New York state, and an additional 8,000 trials involving New York are already running or were recently completed, according to the government clinical trials registry. Patient recruitment is one of the top reasons that clinical trials are delayed or fail, according to the Tufts Center for the Study of Drug Development.

The new collaboration, known as the Partnership to Advance Clinical electronic Research, or Pacer, aims to create a more systematic way of identifying patients for trials by utilizing the electronic patient medical records that many medical centers already use, according to David Krusch, chairman of the Pacer leadership group and chief medical information officer at Strong Memorial Hospital in Rochester.

Currently, the methods used to enroll patients are “very manual” and “cumbersome,” says Dr. Krusch. Typically, trial operators would recruit patients from a hospital or medical center by hanging fliers in the cafeteria or in waiting rooms. The haphazard method often doesn’t yield the right patients or an adequate number in the needed time frame, according to Dr. Krusch.

Methods for patient recruitment have improved over time with more companies making use of recruitment specialists or patient databases, but “there is a lot of hype,” said Ken Getz, a senior research fellow at the Tufts Center who isn’t involved in the New York collaboration. Sometimes an approach works for one study and not another, he said.

Under the new effort, if a patient meets the inclusion standards for a clinical trial, the system would electronically alert the patient’s doctor. The physician could then ask the patient if he or she was interested in participating. Ultimately, the goal is to link up medical center databases across the region.

“Patients aren’t always aware that opportunities are available,” said Dr. Krusch.

To protect patient confidentiality, only the patient’s doctor would be alerted to the potential eligibility for a trial, and the patient would have to give consent, according to Kathleen Ciccone, executive director of the Healthcare Association of New York State, a nonprofit that represents health-care organizations and hospitals and is part of the Pacer coalition.

The Pacer group also includes the Hastings Center, a nonprofit bioethics group, and several medical centers and health-information technology companies.

The group, which says it receives funding from drug makers and health information-technology firms, hopes to come up with standard protocols for clinical-trial eligibility within the next six to 12 months and start rolling out some of the changes two years after that.

Write to Shirley S. Wang at shirley.wang@wsj.com

OPINION

JULY 10, 2009

Bookshelf

Helping Science, Making Money

Drug trials involving 20,000 people or more are now fairly common.

BY SCOTT GOTTLIEB

When I was a medical student, a pulmonary professor of mine cajoled me into joining a clinical trial that she was running. The general aim of the tests was to determine whether prolonged periods of short and shallow breathing would cause a person’s lungs to go into spasm. It turns out, as I can attest, that they do. After essentially panting for one hour, I became so acutely short of breath that I needed an albuterol inhaler to stop me from fainting. That was enough for me — I quit. But my professor called several times, pleading for me to reconsider. She didn’t want to lose me, she said, because I was a “perfect control subject.”

What she didn’t do was offer money as an enticement — a strategy that has become commonplace in recent years as clinical trials increasingly shift from academic settings and into the commercial realm, with companies recruiting and paying tens of thousands of people to participate in tests.

Clinical trials cover a broad range of medical matters, including the testing of new devices, theories (like prolonged shallow breathing leads to lung spasm) and approaches to care. But the most extensive clinical-trial testing is done on new drugs. That has always been the case, but nowadays meeting the ever more daunting requirements of the Food and Drug Administration has become such a logistical burden for pharmaceutical companies that they turn to businesses that specialize in administering clinical trials. These highly profitable companies, and the self-described human “guinea pigs” they hire, are the central focus of Alex O’Meara’s “Chasing Medical Miracles,” his investigation of “the promise and perils” of a $24 billion industry.

Mr. O’Meara himself has served as a clinical-trial guinea pig, and he writes with authority about the growing ranks of people who make something of a living from taking not-yet-FDA-approved drugs. If participants sign up for a long-term study, they’re said to be in “lockdown” until it’s over. Before they can take part in another clinical trial, the guinea pigs must observe a month-long “washout” period “to get all the drugs they ingested from the previous testing out of their systems.”

The author describes a world of clinical trials dominated by secretive companies, working on behalf of big drug makers, that are known (if at all) to trial participants by acronyms such as PPD (Pharmaceutical Product Development) and MDS Pharma Services (the company’s own Web site doesn’t say what the MDS stands for). The clinical-trial business itself is known by the acronym CRO, but Mr. O’Meara notes that even CRO doesn’t have a standard definition — some say it stands for “clinical research organizations” others say “contract research organizations” — which only adds to the industry’s reputation for stealthiness.

Mr. O’Meara worries about the portents of a large business sector’s maintaining such a low profile, but “Chasing Medical Miracles” is not so much an exposé as a worried portrait. The book is framed by the author’s account of his own guinea-pig experience. A lifelong diabetic with “brittle” disease, he has had to endure frequent finger pricks to obtain blood samples that can be checked for sugar levels. He enrolls in a clinical study that will try to stimulate the insulin-secreting activity of the pancreas by transplanting cells from cadaver pancreases.

His clinical-trial experience is the jumping off place for Mr. O’Meara — a freelance journalist who has worked for the Baltimore Sun and Newsday — to apply his reportorial skills to studying the CRO industry. He bunks with guinea pigs during lockdowns, talks to the heads of clinical-trial companies and meets the lawyers developing novel legal theories to sue them when something goes wrong, even though participants sign exhaustive waivers acknowledging the dangers inherent in testing new drugs and innovative medical procedures.

The guinea pigs that Mr. O’Meara trails are mostly in it for the money. Many are students or the marginally employed; not long ago, he says, the ranks of clinical-trial participants were often made up mostly of drying-out drunks and the homeless, but the burgeoning of the CRO business and the need for ever more patients has resulted in sweetened compensation. He’s sketchy on industry-wide rates, but does visit the sign-in for a clinical trail that pays participants $830 in exchange for a three-day confinement and two return visits.

Mr. O’Meara is adept at portraying clinical trials and in discussing ethical concerns — about CROs possibly skewing results to favor the interests of the drug companies that hire them, and about the financial incentive for clinical-trial applicants to lie about their medical history. But he gives too short shrift to the legal and regulatory forces that have prompted the rise of the CRO.

With the FDA increasingly concerned about ensuring drug safety, new layers of rules and requirements — including much wider and more extensive testing — have been added to an already complex approval system. A decade ago, a trial for a new blood-pressure pill might have enrolled a few thousand participants. Now late-stage trials on 20,000 people or more are fairly standard for these kinds of primary-care drugs. It is often simply beyond the capacity of an academic medical center or even a big pharmaceutical company to recruit and monitor the highly specific and often “treatment naïve” patients that the FDA typically requires.

As for the clinical-trial patient Alex O’Meara, the experimental cell-transplant diabetes treatment works for a time. He’s able to go off insulin and reduce the frequency of blood-sampling finger pricks. But eventually the transplanted cells start to fail. At the book’s close, he is clinically better off but not cured, satisfied just to have taken a shot — and content in the knowledge that he might have helped, in some small way, the advance of medicine.

Dr. Gottlieb, a practicing physician and resident fellow at the American Enterprise Institute, was a deputy commissioner of the Food and Drug Administration from 2005 to 2007. He is on the boards of two health-care companies that do business with CROs.

Copyright 2009 Dow Jones & Company, Inc. All Rights Reserved

Clinical trials in third world and other foreign countries are facing closer examination following several deaths, according to the Wall Street Journal. The article by Shirley S. Wang, Geeta Anand, and Jeanne Whalen, describes the unfortunate and wrenching death of an infant in India who was enrolled in a trial. The story says more scrutiny is being paid to overseas trials conducted by western drug companies in particular because those companies are running many more trials than before. They point out, as I did in a more in-depth examination of the globalization of clinical trials in Chasing Medical Miracles, that the cost of a trial in a developing country can cost half as much as running it in the United States.

In order for trial results to be valid for approving a drug, procedure, or device for sale in the U.S., the FDA stipulates that the overseas trial meets either the standards of the country where they are taking place or lives up to the Helsinki Declaration, whichever is more stringent. Many host countries, such as China, India, Russia, and others, have lax regulations. Frequently under-developed countries, find it’s in their interest to avoid imposing tough laws. The countries are so poor that they want to attract clinical trials because they provide people with medicine and other “treatment” that the government cannot provide.

When I went to Uganda to research my book I found that the government, universities, independent doctors, and the health ministry were working hard to impose tougher regulations to govern clinical trials. Other countries, however, didn’t even appear to be trying, as I discovered and wrote about in Chasing Medical Miracles:

One man, Ilian Ivanov, for instance, oversees the regulations governing clinical trials in Bulgaria. He is simultaneously the regulator and recruiter of companies to come and conduct trials in Bulgaria and he openly aspires to someday be employed by a pharmaceutical company, just like the man who occupied his post before him. Part of his $100 monthly paycheck goes toward a bottle of whiskey he keeps at the ready for visitors to his office. Ivanov insists he’s no pushover for allowing sponsors of clinical trials to cut corners. Two Bulgarian researchers felt his regulatory wrath once when he caught them conducting trials without government permission. He slapped them with a $10 fine.

To read the full Wall Street Journal article, click here. (A subscription is required but a free trial subscription is available.)