From Gooznews Jan 26, 2008
The Lessons From Vytorin
Merrill Goozman

"... A generation ago, the drug industry accounted for about a third of clinical trials, while academic medical centers, using largely government funds, accounted for two-thirds of the tests. Today, that ratio is reversed. One estimate I’ve seen suggested industry spends over $20 billion a year on clinical trials, well over half of its collective research and development budget.

Has the time come to begin asking whether our privatized system of clinical trial research is serving the nation’s health? The fact that a drug like Zetia can be approved and sold to millions of people for nearly a decade without any evidence that it actually saves lives is absurd.

The FDA has the authority to order companies to conduct conclusive post-marketing trials, but when it does, the companies often delay complying or ignore the requests and the agency does nothing. I am not aware of a single instance where the agency has removed a drug from the market for failing to complete a requested post-marketing trial.

There’s much talk these days about identifying new biomarkers – like cholesterol – that will help industry end its drought in bringing new drugs to market. But why should the public trust the claims made on any new biomarker’s behalf when industry drags its feet in testing its validity in the only place where it matters – in a clinic trial testing whether affecting that biomarker actually improves health?

Our health care innovation system now relies on industry to finance clinical trials. But let’s not forget that the money spent on R&D is derived from patients and their insurers. It is a current cost of doing business, and accounts for about 20 percent of the price of every pill we pop. Perhaps the time has come to give patients more say over how that money gets spent.

One of the chief reforms talked about in the push for health care reform is creation of a new agency, either independent or within the government, that can conduct comparative effectiveness research on existing therapies. As the health care policy community debates such an agency’s shape and scope, it should also include the possibility that it manage all late-stage pre-approval and post-marketing trials.

Companies would pay user fees for the trials, just as they now pay user fees to the FDA to review their results. But the new agency would design the protocols and manage the process to ensure that information derived from the trials maximizes the knowledge that will improve public health and can be trusted because industry influence over the conduct of the trial has been eliminated.

Dean Baker of the Center for Economic Policy and Research has suggested that all clinical trials get run through such an agency. But, in my view, early stage safety and proof-of-concept trials should stay in companies’ hands. Centralization to early-on in the process might result in frustrated innovators accusing the government or whoever ran this agency of picking winners and losers, or dampen capital markets’ willingness to invest in start-up firms because they believe “the agency” has become too tough in allowing experimental drugs into the pipeline.

But the new gold standard for medical research should become the completely independent, double blind, placebo-controlled trial for truly new therapies and the completely independent double-blind, comparison-controlled trial for competing therapies.

The government has a long history of financing and managing clinical trials through the National Institutes of Health, especially the National Cancer Institute. Yet its authority and centrality has been undermined in recent years as industry-funded trials seized center stage. Meanwhile, companies have an equally long and sordid history of refusing to fund or follow through on clinical trials that might jeopardize their bottom lines, while crucial gaps in the information about new therapeutics go unaddressed.

To answer the question posed at the beginning of this post: the Vytorin episode teaches us that the time may be at hand to relocate responsibility for the nation’s clinical trial research enterprise."
Posted by gooznews at January 26, 2008 10:10 AM

http://www.gooznews.com/archives/000947.html