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TRENDSPOTTER: Take Notes from the Stem Cell Controversy: Stand Up and Be Heard!

THIS IS not a column about whether the National Institutes of Health should continue to fund stem cell research. Having said that, my own view is that stem cells are neither less nor more important as tools for curing or treating diseases than other technologies. More to the point, genomics offers many more ways to detect and prevent disease than does stem cell technology (and indeed, without genomics, the mutations and glitches all manner of stem cells encounter en route to becoming differentiated may never be overcome).

In any event, while the genomics community may have a keen interest in the outcome of this debate, the most important lesson it can learn is how individual scientists can make a difference and generate a national dialogue and increased awareness when something important is at stake. The question is, will you, reader, take up the challenge? Today, the incentives and activities essential to development of genomics are at risk. Interest groups such as Public Citizen and Families USA in Washington are discrediting the role private companies have in discovering and developing new drugs and are proposing to replace the private sector with a public utility model for medical progress, drug discovery, and drug development.  

These organizations propose eliminating patent protection and adding billions in funding to the NIH which, in turn, would take over the job now being done by drug companies, biotech firms and, by extension every genomic company out there. The following quote, from Dean Baker's "Patent Medicine" article in the January 29 th American Prospect,  reflects a view being widely promoted and being taken seriously by policymakers and journalists without a full understanding of the facts: 

...the patent system is not the only way to support drug research. Alternatives that have a proven track record of success already exist--specifically, research supported by foundations, universities, and the government. Shortening patent terms and putting most pharmaceutical research in the public domain would cut costs for consumers as well as for government. And contrary to industry propaganda, doing so would not reduce innovation. ...Historically, the NIH has focused on basic research and early phases of drug testing, whereas the pharmaceutical industry has been primarily engaged in the later phases of testing, which include clinical trials and carrying drugs through the FDA-approval process. But this division of labor is arbitrary. The NIH has done research in all areas of drug development; in some cases, the agency has even secured FDA approval. There is no reason to believe that, given enough funding, the institutes could not oversee all phases of drug research at least as effectively as the pharmaceutical industry does at present.

This is nonsense and second-rate socialism. Pharmaceutical firms spend $3 billion a year on basic research, according to the Tufts Center for the Study of Drug Development. According to statistics from the Biotechnology Industry Organization, biotech companies spend roughly $5 billion more drawn from funds not provided by drug firms. That exceeds what the NIH spends on actual clinical basic research (both intramural and extramural spending)--approximately $5 billion--in a ratio approaching two to one. None of this includes the hundreds of millions the private sector outspends the government in genomics related research. What's more, if drug development is such a slam-dunk for government labs, why have thousands of compounds available under tech-transfer agreements never been developed? Why haven't other governments such as Brazil and India, both with a bevy of excellent scientists, generic companies, and weak patent laws, developed centers of biomedical innovation? 

But this view is largely unchallenged in the popular media and in policy circles and is increasingly accepted by Americans who are told medical miracles come cheap and easy, but for the big, bad drug companies. If you don't start speaking out, you and your companies will get caught in the political crossfire. Consider some of the articles and press releases I have come across in recent weeks about the recently announced $1.1 million in additional funding for the NCI/FDA joint program in proteomics. The Wall Street Journal , The New York Times,  and The Washington Post all reported the program as some new frontier in medicine. Yet, over six months ago Large Scale Biology Corporation's proteomics subsidiary completed the first version of a planned master database of all proteins in the human body. That item and all the other private sector work in proteomics goes largely ignored. Members of Congress that I have spoken to are unaware of these ventures or even what constitutes proteomics. Now that the NIH is entrenched in the business, they will know, and guess who will get the credit? 

The enemies of medical progress want the public to believe that you and your companies don't count, don't deserve patent protection, and shouldn't be profitable. I believe that the commercialization of biomedical knowledge has been and will be critical to making medical progress a reality in the 21 st  century. I want to hear from those of you looking to speak out and make a difference. And I would suggest writing your own articles and meeting with journalists and members of Congress in an organized fashion as scientists are doing now on the stem cell question.  It's not just your stock options that are at stake, it's the future of medical progress that is in the crosshairs. Together we can educate and inform the public and policymakers on this important issue.

Robert Goldberg is a senior fellow at the National Center for Policy Analysis and a senior research fellow at the Ethics and Public Policy Center. You can e-mail him at  [email protected]  . 

Trendspotter  is a weekly column that focuses on how trends in politics, patent law, and the US and European markets will affect the genomics industry. The column appears every Friday.

To access previous columns just enter the word "Trendspotter" in the archive search window on the homepage.

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