[Congressional Record (Bound Edition), Volume 151 (2005), Part 6]
[Extensions of Remarks]
[Page 8776]
[From the U.S. Government Publishing Office, www.gpo.gov]




RISK AND RESPONSIBILITY: THE ROLES OF FDA AND PHARMACEUTICAL COMPANIES 
          IN ENSURING THE SAFETY OF APPROVED DRUGS LIKE VIOXX

                                 ______
                                 

                        HON. DENNIS J. KUCINICH

                                of ohio

                    in the house of representatives

                         Thursday, May 5, 2005

  Mr. KUCINICH. Mr. Speaker, thank you for the opportunity to speak 
about this critical public health issue that has affected the entire 
U.S. The Vioxx case presents us with a valuable opportunity to examine 
an industry in order to help it improve. The problem is not only that 
the FDA does not have sufficient regulatory authority to protect the 
public, though that is certainly true. The problem actually lies with 
the way pharmaceuticals are priced. I'll explain.
  In the Vioxx case, Merck displayed a litany of predatory behavior. 
Vioxx research teams were stacked with people who had financial 
associations with Merck. Merck manipulated research protocols. They 
delayed publication of negative findings about Vioxx. They succeeded in 
getting people to take Vioxx that did not have a medical need by 
spending $161 million for direct-to-consumer advertising alone. And 
direct lobbying to doctors is a well-known practice that has the same 
result. Lastly, 10 members of a 32-member FDA advisory board in charge 
of determining whether Vioxx should continue to be allowed on the 
market, had ties to industry. Had those advisers abstained, the 
committee would have voted that Vioxx should not return to the market. 
And these are only the things we know about. More concerns are likely 
to be uncovered as we dig deeper.
  Would Merck be doing all this if Merck was the only maker of Vioxx? 
Absolutely not. When there is competition in manufacturing, just like 
there is in most other sectors, the capability to squeeze so much 
profit from a single drug is gone. But under a monopoly, which is what 
Merck has with its patented Vioxx, the sky is the limit on profits. 
Only the patent holder or licensee can sell it, so they control the 
market. And when a company controls the market, they have considerable 
leeway to corrupt the process in ways similar to what we have seen with 
Merck.
  The usual justification for patent monopolies is that patents are 
yielding innovation, which is critical for new pharmaceuticals. But we 
are not getting that innovation. The number of New Molecular Entities 
approved by the FDA has been in decline several years running. Copycats 
or me-too's constitute roughly 70 percent of new FDA approved drugs. In 
other words, the pipeline is drying up.
  If we want to avoid another Vioxx down the road, we need to get to 
the root of the problem. We need to bring innovation back up, control 
perverse incentives, and drive drug prices back down to a similar level 
as other developed nations. We do that by changing the financing of 
pharmaceuticals.
  Put simply, the NIH, which is currently responsible for much of the 
innovation in pharmaceutical research, should drastically increase its 
already successful pharmaceutical research program. The innovations 
that result should be available for any qualified entity to 
manufacture, which would introduce competition into the market. It 
would boost innovation, competition would drive down prices as it does 
in the generics market, and the incentive to engage in Merck-like 
behavior would be drastically reduced.

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