Faulty Clinical Trials Just Symptomatic of a Bigger Social Problem

Last week pharma blogger Ed Silverman interviewed former NPR reporter Snigdha Prakash about her new book, 'All The Justice Money Can Buy,' an account of litigation against Merck's Vioxx. Silverman asked Prakash what surprised her most during the many months that she was "embedded" with the plaintiffs' lawyers.

"I think what really shocked me," she said, "was the extent of the scientific manipulation...I didn't understand about manipulating clinical trial data and couldn't believe a company of Merck's stature could be doing that."

As more and more trials will be conducted at foreign sites in Eastern Europe and Asia that are not closely monitored, the authenticity of clinical trials will become an even bigger question. A story that's been going around the industry the past two years, while probably apocryphal, illustrates the point.

The director of clinical trials for a large pharma company was supposedly speaking with a clinic manager in a region of the Balkans formerly behind the Iron Curtain. The local manager, knowing that the pharma director was responsible for signing up investigators, tried to pitch his clinic's virtues. For starters the manager said that he could enroll a large number of patients in the company's upcoming trial. The director appeared unimpressed. Pursuing another avenue, the manager said his clinic would charge 20% less per patient than any other Eastern European clinic for running a trial in the test drug's therapeutic class. Again the pharma company's trials director seemed underwhelmed. Finally, knowing that obtaining favorable results for the test drug was the main goal of any pharma company, the manager said, "You vant vin, ve give you vin."

Questions concerning data manipulation and the oversight of clinical trials are actually just symptomatic of an issue that is larger than the pharmaceutical industry. As Prakash sees it, "It's not just Merck and it's not just the drug industry. It's the financial industry. People lost their houses…There's a common theme – a failure of government regulation. I think the theme I kept coming up against is that these were powerful actors and consumers trusted them."

The past 30 years, as the Friedman-Reagan-Bush approach to political economy became the norm in this country, the US has outsourced responsibility and integrity to the major corporations. These corporate oligarchs benefit from an ideology whose first principle holds that the market is omniscient, efficient, ethical and benevolent. Sadly, this is also the view that has prevailed in the Obama administration under Tim Geithner. The executive branch's economic managers claim that if the oligopoly that controls an industry, say financial services, acquires sufficient resources and is left to its druthers, the general public will benefit. The market will see to it.

This presumption of the self-regulating market is the reason investment banks such as Goldman-Sachs were bailed out at 100 cents on the dollar, while people who were laid off from their jobs and went delinquent on their mortgages were left to their own devices. Geithner and Fed chairman Ben Bernanke assumed that if taxpayers provided the big investment bankers with enough money to cover their losses, the banks would keep lending to businesses and avert an economic collapse. Geithner and Bernanke expressed shock when the banks remained stingy on their lending and, instead, used the money to pay their top managers multi-million dollar bonuses.

Clearly if managing a national economy is too important to trust to the likes of Goldman-Sachs, then one must at least ask what justifies placing similar faith in pharma oligarchs to manage the nation's medicine cabinet.

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