) Erbitux that has run into trouble. A number of promising drugs, some treating heart disease, have recently met with long delays or washed out. Fueled by venture capital, biotech requires different financial and regulatory models than Big Pharma. While regulators must still ensure safety, there's a need for speed. While they must guard intellectual capital, they must also make their procedures more transparent to both scientists and investors.
The FDA can begin by removing much of the secrecy from its operations. ImClone worked with the FDA to design its small-scale trial of Erbitux, but was then told in a private letter that there were flaws and the results would not be accepted. More data was needed. When this leaked out, cancer patients were disappointed, the stock plummeted, and investors got clobbered. New leaks have now sent the stock soaring. What is going on? The FDA must provide better guidance to scientists, patients, and investors by opening its drug review procedures.
Biotech companies, for their part, have to get real. CEOs spin tales of miraculous cures to Wall Street even before results are in from early trials. The goal often appears to be to boost stock prices and their own personal wealth. Many trials are underfunded and far too small to draw proper scientific conclusions about efficacy. New biotech technologies allow for smaller, speedier testing, but some companies are cutting corners, rightly forcing the FDA to demand more data.
It would help if the Bush Administration finally landed an FDA chairman who could shake up procedures. The appointment has been caught up in abortion politics, to the detriment of people with cancer. Biotech companies would do well to appoint real boards of directors--not pals, investors, and self-interested scientists--to moderate claims and expectations.
Biotech promises to be an engine of growth in the years ahead. But unless the FDA and biotech entrepreneurs learn to work with one another, the promise of new drugs to cure cancer and other deadly diseases will be delayed, if not denied.