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Sloppy Data in Clinical Trials Conducted by Big Pharma in China

Posted Jul 22 2013 12:00am

I have posted previous notes about the offshoring of clinical trials (see, for example:  Clinical Trials Increasingly Move Offshore, Many to China ). I previously believed that this trend would continue, and even accelerate, because they were less expensive and it was easier to recruit subjects for them, particularly those who had never been treated for their disease. Now, partly on the basis of a recent article, I am not so sure about this conclusion (see: Chinese clinical trials probed ). Below is an excerpt from it:

Drugmakers have increasingly been turning to China for large clinical trials because they’re cheaper and there’s a bigger population of subjects to draw on. Now U.S. regulators have stepped in, questioning sloppy data and irregularities from the world’s most populous country. Bristol-Myers Squibb Co. and Pfizer Inc.’s blood thinner Eliquis, approved in December, was stalled for nine months because of misconduct, errors and an alleged cover-up attempt at a Chinese trial site overseen by Bristol-Myers....The delay came after the company told the FDA that patients got the wrong medicine, records were secretly changed and “serious adverse events” went unreported, the documents show. The errors led to a lengthy reanalysis of the data and spurred a debate within the agency on what the drug’s label should say about its effectiveness. An agency official also questioned whether large trials in countries like China with similar data shortfalls were a viable basis for approving treatments....The mistakes showed a “pattern of inadequate trial conduct and oversight,” according to minutes of a Feb. 9 agency meeting involving the two New York companies and the FDA, posted on the agency’s website. Sales for Eliquis may one day reach $10 billion a year, according to analysts. The delay, though, may cut the time Eliquis is protected by patent, reducing revenue by billions of dollars. The Eliquis case is an example of the increasing scrutiny the pharmaceutical industry is facing on its research in China, which offers a huge base of test subjects and costs that...can be half those in the United States. Drugmakers will keep having problems with sloppy data and misconduct as long as they keep doing trials in places like China without providing better oversight, said Thomas Marciniak, an FDA medical team leader....“What we need is high-quality trials. If we’re not getting them in the low-cost areas, either fix the low-cost areas, or stop doing them,”....Last month, London-based GlaxoSmithKline said it fired its head of Chinese research after the scientist allegedly misrepresented data that was published in a medical journal [see:  GSK fires China research head over 'misrepresented' data ].

The FDA has a powerful weapon in its ability to stall the drug approval process in the U.S. because of errors in the clinical trials conducted in China. Such delays can cost a company dearly in terms of a reduction in the length of patent protection if the new drug ultimately comes to market. Such costs can add up quickly and offset the savings initially enjoyed by the company by moving the trials off-shore. Graft and corruption will often be the norm in business conducted in developing countries. Drug companies will hardly be able to change the norms in these countries. There may also be the problem of the FDA perception that all such studies in China may be inherently tainted (see: Why Bribery is Rampant in China’s Healthcare System ). Finally, recent reports have suggested that the pharmaceutical companies themselves may be active and knowing participants in bribery schemes (see: China names 4 GSK managers in drug bribery probe ).

It's one thing to manufacture computer chips or PCs in China. Such physical goods should be made to precise specs and can be checked for defects. It's another thing to contract for services such as clinical trials where the deliverable is in the form of information. It will be much more difficult for a company to detect corruption in the recruiting of subjects or whether patient serum specimens are subjected to "sink testing" (poured down the drain with the test results fabricated)? In fact, the methodology of clinical trials in general is now being questioned (see: Do Clinical Trials Work? ). Look for more serious scrutiny of clinical trials held abroad by the FDA with Big Pharma beginning to recalculate the ROI of conducting such trials in developing countries like China.

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