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Clinical Questions for a New Decade

By Kevin Davies

February 1, 2011 | First Base | One doesn’t often expect to stumble upon exceptional science writing while perusing the requisite Hollywood celebrity interview in the pages of Vanity Fair (this month, Johnny Depp, complete with obligatory Annie Liebovitz photo spread). But the magazine kicked off 2011 with a devastating story revealing the downside of the globalization of clinical trials. The piece, entitled “Deadly Medicine,” described the consequences of the explosion in clinical trials in Southeast Asia, Eastern Europe and just about everywhere else. “Throw a dart at a world map and you are unlikely to hit a spot that has escaped the attention of those who scout out locations for the pharmaceutical industry,” write Donald Barlett and James Steele.

Globalization, the authors argue, pushes trials largely beyond the clutches of the Food and Drug Administration (FDA), which annually checks on less than 1 percent of trial sites outside the U.S. No surprise, then, that many high-profile drugs tested outside the U.S. have experienced major safety issues, including Avandia (GlaxoSmithKline), Seroquel (AstraZeneca), and Ketek (Sanofi-Aventis). Systemic problems, including allegations of fraud, extend to contract research organizations that conduct trials around the world and the bureaucracy (or incompetence) of the FDA itself. (The article also documents serious deficiencies in manufacturing plants. Such quality control issues in China have been widely publicized, but last year, GSK paid a $600 million fine after a whistleblower flagged major problems at a Puerto Rico manufacturing facility.)

“The only people who seem to care about the surge of clinical trials in foreign countries are the medical ethicists—not historically a powerhouse when it comes to battling the drug companies,” Barlett and Steele note. They point out that the estimated number of accidental deaths from FDA-approved prescription drugs—some 200,000 annually—dwarfs the number of people who die from illegal street drugs. “After a dozen or so deaths linked to runaway Toyotas, Japanese executives were summoned to appear before lawmakers in Washington and were subjected to an onslaught of humiliating publicity. When the pharmaceutical industry meets with lawmakers, it is mainly to provide campaign contributions,” they write.

Flat Line

This unsettling state of affairs falls against a backdrop of stagnation in new drug approvals that shows little sign of improvement. According to preliminary figures, the FDA approved just 21 new drugs in 2010, a dip from the 24 and 25 drugs approved in 2008 and 2009, respectively. There were a few highlights, including new biologicals from Amgen (osteoporosis), Genentech (rheumatoid arthritis) and Boehringer Ingelheim (blood thinner). But safety concerns stalled or postponed decisions on several other highly touted compounds, while the agency looks set to revoke the approval of Roche’s Avastin for breast cancer.

To start off a new year, we have devoted much of this issue of Bio•IT World to an appraisal of the clinical trial machine. The heart of the issue is a superb article from Deb Borfitz (see p. 18). In addition, we present the opinions of a variety of eClinical trial stakeholders, including a pharma biostatistician, a software CEO, and an in-demand clinical consultant. There is cautious optimism that clinical trials are becoming more efficient, helping identify and pull less-effective drugs sooner.

But as we have documented numerous times, the predictive tools for making those decisions are hardly foolproof. While some see big pharma buying innovation in the form of biotechs and/or outsourcing more and more of its R&D activities, others, including GSK, are revamping operations to emulate the nimbleness and perceived innovation of their biotech brethren. But big pharma is still hedging on the introduction of next-generation genomic analysis techniques for patient stratification. One big pharma department chief with a strong genomics background told us he hesitated to approve widespread implementation of NGS because of lingering concerns about the accuracy of the data.

That day will come soon, if not in 2011. 23andMe, which last summer published an encouraging study mapping genes for complex traits based on self-reported customer data, has received NIH funding for a pharmacogenetic study on consumer drug response. The company believes that “advancements in computing and the ubiquity of the Internet enable new approaches to research that are sound, valid and will be an important complement to traditional clinical trials.”

In the meantime, we hope that the various clinical tools and strategies discussed in this issue, coupled with the ingenuity and integrity of those implementing them, will make this a decade to remember.

This article also appeared in the January-February 2011 issue of Bio-IT World Magazine. Subscriptions are free for qualifying individuals. Apply today.

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