|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 12-13-2004
Nonprofit Drug Company Gets Gates Grant to Target Malaria
The Institute for OneWorld Health, a nonprofit drug company devoted to creating affordable and accessible cures for diseases that afflict the world’s poorest nations, is expected to receive a $42.6 million dollar grant from the Bill and Melinda Gates Foundation a develop a synthetic version of the antimalarial drug artemisinin.
Artemisinin is currently harvested from a Chinese shrub, a very time-consuming and expensive process. The Institute for OneWorld Health worked with a chemical engineer at the University of California at Berkeley to genetically engineer E. coli bacteria to produce artemisinin. Later, the “the university issued a royalty-free license to OneWorld Health and Amyris Biotechnologies, a private Biotech company in Emeryville, Calif., which will begin scaling up production of the synthetic artemisinin compound. In return, Amyris has agreed to sell the drug at cost. OneWorld will handle drug development and regulatory work to demonstrate that the synthetic version is equivalent to the natural product.”
OneWorld is a promising example of the new philanthropic partnerships and innovative thinking required to bring new medicines to developing nations that are unable to afford standard treatments.
Study Suggests Way to Predict Whom Antidepressants Help
For the first time, researchers have been able to identify a genetic variation that correlates with patient response to antidepressants. In an article published in the journal Molecular Psychiatry, “doctors from Harvard and the University of California, Los Angeles, treated with drugs 54 Mexican Americans in Los Angeles who were both depressed and highly anxious. (Limiting the study to one demographic group was a control tool.) They found that 60 percent of the group had a common genetic variant that helps govern the body’s response to stress.”
Patients with this genetic variant “were far less anxious and depressed than when they began the study” and, conversely, “depressed patients who did not have the variation got much less relief from the drugs.” Eventually, as researchers learn more about this genetic variant, it may be possible develop targeted antidepressants for patients who are resistant to traditional therapies.
Celebrex warning echoes safety failures; An analysis shows that, as the number of new drugs like Celebrex -- now linked to heart attack risks -- being given first to Americans has increased, reports of drug-induced ailments have grown.
This article is pretty grim in its appraisal of the U.S. drug safety monitoring system. But just because the safety system needs fixing doesn’t mean that the approval system itself is flawed. The U.S has more new drugs approved here first than anywhere else in the world – meaning that U.S. citizens get first crack at new medicines that save lives, reduce disability, and lower other costs associated with debilitating or fatal diseases like cancer and heart disease.
Right now the FDA has a passive reporting system for drug adverse events, and that needs to change – but as part of a total reform package, which the FDA unveiled as its Critical Path initiative last year. By shifting to an “active” drug safety system, and working with health insurers to monitor adverse drug events track and off-label use of drugs, the FDA can mine a wealth of data that would’ve been impossible 10 years ago.
Funding for an active safety monitoring system is also sorely lacking. The blame for that problem lies with Congress, not the FDA. Giving the FDA the power to do better datamining and the budget to do it with should be high on Congress’ priority list in 2005.
This article notes that the industry has been facing an R&D bottleneck since the late 1990s. “The decline in drug research and development has been an open secret among analysts and scientists for years. But drug company executives have insisted that their industry is fundamentally healthy and expensive research will pay off.”
For instance, “the number of new drugs approved by the Food & Drug Administration has declined sharply since the mid-1990s, falling from 53 in 1996 to 21 in 2003, even as the industry has nearly doubled its annual spending on drug development, to about $33 billion. Further complicating the process, many drugs already on the market do a reasonably good job, so the bar that new therapies – most of them expensive – must cross is very high.”
What the article doesn’t tell us is that we are still developing the tools that will allow us to integrate new advances in genetic science and computer technology into the drug development process. That is happening, and it needs to happen faster. However, industry watchers need to remember that the “critical path” from lab bench to bedside can take up to a decade: cutting edge medicines developed with genomic technology now won’t come online for another decade. In other words, keep the pessimism in check. Science never stands still.
This interview with Biogen Idec CEO James Mullen is a fascinating read. Mullen describes both the challenges facing the industry and the possibilities for the future growth of medical technology. Says Mullen: “The industry continues to underestimate the complexity of human biology and disease. We know 10% of what we need to know. The knowledge is accumulating at a dizzying pace, but because we know so little, we have some spectacular failures. I think its going to be some time before those statistics [on the enormous unpredictability and expense of drug development] turn around.”
On the topic of price controls and U.S. innovation, Mullen says that while U.S. consumers may be “footing the bill for innovation that is enjoyed worldwide,” the venture capital that drives the biotech industry is simply not available in Europe because the financial rewards (i.e. profits) are not there, as they are in the U.S. Consequently, the “U.S. has a huge lead in biotech jobs.”
Mullen’s description of the challenge facing biotech companies is reminiscent of an old Eastern European proverb: We know that we can turn an aquarium into fish soup, but can you turn fish soup into an aquarium?
Biotech companies have tremendous resources and a fast-growing knowledge base in systems biology and pharmacogenomics – but no one knows quite how to put all the pieces together in order to model real diseases and complete biological systems. Until we do, the industry will be in for more “catastrophic failures.”
Still, progress in biotech markets isn’t about tremendous leaps of innovation but in incremental steps where clinical knowledge and lab bench innovation work hand in glove.
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