The required legislation should ensure that patients have control over their tissues. I donate my tissues for a purpose, and that purpose only. If, later, someone wants to use them for another purpose, they need my permission again. If they can’t get permission, they can’t use my tissues.
Such a rule fulfills an important emotional need. But it also acknowledges that there may be significant legal and religious reasons why I do not want my tissue used for another purpose.
We should not fear that such regulations will inhibit research. After all, the National Institutes of Health seems to be able to conduct research while following these guidelines. Nor should we accept the argument that these rules impose an onerous burden. If a magazine can notify you that your subscription has run out, a university can notify you if they want to use your tissues for a new purpose.
3. Pass laws to ensure that data about gene testing is made public. New legislation is needed if the FDA is to publish adverse results from gene therapy trials. At the moment, it cannot do so. In the past, some researchers have tried to prevent the reporting of patient deaths, claiming that such deaths were a trade secret.
The public is increasingly aware of defects in the systems we use to report medical data. Research data has not been made available for other scientists to inspect; full disclosure has not been required; genuinely independent verification of findings is rare. The result is a public exposed to untold unknown hazards. Bias in published studies has become a bad joke. Psychiatrist John Davis looked at the trials funded by pharmaceutical companies in competition for the most effective of five different antipsychotic drugs. He found that 90 percent of the time, the drug manufactured by the company sponsoring (paying for) the study was judged superior to the others. Whoever paid for the study had the best drug.
This should not be news. Review studies conducted by those who have a financial or other interest in the outcome are not reliable because they are inherently biased. That fact should be addressed by an information system that does not permit biased testing, and takes steps to ensure that it does not occur. Yet gross bias remains far too common in medicine, and in certain other areas of high-stakes science as well.
Government should take action. In the long run there is no constituency for bad information. In the short run, all sorts of groups want to bend the facts their way. And they do not hesitate to call their senators, Democratic or Republican. This will continue until the public demands a change.
4. Avoid bans on research. Various groups of different political persuasions want to ban some aspect of genetic research. I agree that certain research ought not to be pursued, at least not now. But as a practical matter, I oppose bans on research and technology.
Bans can’t be enforced. I don’t know why we have not learned this lesson. From Prohibition to the war on drugs, we repeatedly indulge the fantasy that behavior can be banned. Invariably we fail. And in a global economy, bans take on other meanings: even if you stop research in one country, it still goes on in Shanghai. So what have you accomplished?
Of course, hope springs eternal, and fantasies never die: various groups imagine they can negotiate a global ban on certain research. But to the best of my knowledge, there has never been a successful global ban on anything. Genetic research is unlikely to be the first.
5. Rescind the Bayh-Dole Act. In 1980, Congress decided that the discoveries made within universities were not being made widely available, to benefit the public. To move things along, it passed a law permitting university researchers to sell their discoveries for their own profit, even when that research had been funded by taxpayer money.
As a result of this legislation, most science professors now have corporate ties-either to companies they have started or to other biotech companies. Thirty years ago, there was a distinct difference in approach between university research and that of private industry. Today the distinction is blurred, or absent. Thirty years ago, disinterested scientists were available to discuss any subject affecting the public. Now, scientists have personal interests that influence their judgment.
Academic institutions have changed in unexpected ways: The original Bayh-Dole legislation recognized that universities were not commercial entities, and encouraged them to make their research available to organizations that were. But today, universities attempt to maximize profits by conducting more and more commercial work themselves, thus making their products more valuable to them when they are finally licensed. For example, if universities think they have a new drug, they will do the FDA testing themselves, and so on. Thus Bayh-Dole has, paradoxically, increased the commercial focus of the university. Many observers judge the effect of this legislation to be corrupting and destructive to universities as institutions of learning.
Bayh-Dole was always of uncertain benefit to the American taxpayers, who became, through their government, uniquely generous investors. Taxpayers finance research, but when it bears fruit, the researchers sell it for their own institutional and personal gain, after which the drug is sold back to the taxpayers. Consumers thus pay top dollar for a drug they helped finance.
Ordinarily, when a venture capitalist invests in research, he or she expects a significant return on investment. The American taxpayer gets no return at all. The Bayh-Dole legislation anticipated that the public would receive a flood of marvelous life-saving therapies such that the investment strategy would be justified. But that hasn’t happened.
Instead, the drawbacks far outweigh the benefits. Secrecy now pervades research, and hampers medical progress. Universities that once provided a scholarly haven from the world are now commercialized-the haven is gone. Scientists who once felt a humanitarian calling have become businessmen concerned with profit and loss. The life of the mind is a notion as quaint as the whalebone corset.
All these trends were perfectly clear to observers fifteen years ago; no one paid much attention back then. Now the problems are becoming clear to everyone. A good first step toward restoring the balance between academia and corporations will be to repeal Bayh-Dole legislation.