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Diffusion and Use of Genomic Innovations in Health and Medicine: Workshop Summary
said. Furthermore, companies, in order to make money, study the wrong things because of the way incentives are structured. If one could create a more streamlined system and actually define the value of the products as opposed to developing marketing schemes that are tangential to the value, one could focus on defining what actually works.
Gelijns mentioned that the history of pharmaceutical innovation is full of new and often unexpected indications of use that emerge in the post-marketing setting. What is needed may be a more streamlined process for looking at evidence, not only of unexpected side effects, but also of unexpected benefits. One important issue is how much room to leave for experimentation.
One audience member said that he thought that a major player in innovation and translation—the pharmaceutical companies—was being ignored. In 1998 a drug that had a 4 percent complication rate of hypersensitivity syndrome (abacavir) was released with an accelerated approval that required risk-management studies to be conducted. As a result, some early-stage pharmacogenetics were conducted. At the time, it was the only product in its class. Other products in the class have now entered the marketplace, and each of them has a different type of adverse event.
From the company’s point of view, if there was a highly accurate test that demonstrated that the adverse event for its drug could be avoided, the company would have a competitive advantage to getting that put on the label. That is, in fact, what happened. There is now a test that can identify, with greater than 99 percent specificity, the people who will suffer hypersensitivity syndrome if they take abacavir. For the first time there is a diagnostic test for a drug allergy.
Month by month the sales of this test, which did not come out simultaneously with the drug, have quadrupled, according to the audience member. Yet this information has not been published in any of the scientific journals. This example illustrates the fact that if there is a competitive situation and market share is at stake, a huge incentive exists to make the investment needed to implement the test, even if there is no reimbursement for the test. It might even be considered unethical to give the drug without testing.
It is important, the audience member concluded, not to restrict thinking about incentives to academia and the government, but rather to expand incentives to include those who can change the system, such as pharmaceutical companies.