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6 S e p t e m b e r 2003 PharmaVOICE RAISE your voice Few lessons learned I am writing to offer my feedback about the article “The Lessons of Greed” in the July 2003 issue of PharmaVOICE. As a clinicalresearch professional involved with ensuring the ethical conduct of clinical trials, I have closely followed the case of Bruce Diamond and Dr. Richard Bori son since they were indicted on fraud charges in 1997. I challenge Bruce Diamond’s assertion in your article that he and Richard Borison did not risk the health of patients. Your article did not mention that Mr. Diamond (a nonphysician and not authorized by law to dispense or prescribe medicine) was convicted by the state of Georgia for forging Dr. Borison’s name on prescriptions for controlled substances and dangerous drugs, a practice that the FDA claims “created a risk of injury to consumers.” Mr. Diamond also was convicted of bribing an employee to obtain her silence and cooperation about an attempted sui cide of a subject enrolled in one their clinical tri als. Again, the FDA stated that this demonstrat ed a “wanton disregard for the public health.” In your article, Mr. Diamond states, “What we did was not research misconduct.” According to the FDA, research misconduct is defined as fabrication, falsification, or plagiarism in propos ing, performing, or reviewing research, or in reporting or analyzing research results. By this standard, what Mr. Diamond and Dr. Borison did was certainly misconduct as they were con victed of making false statements about their involvement in clinical research at the Medical College of Georgia. I saw Mr. Diamond speak in April at the Asso ciation of Clinical Research Professionals meeting where he offered several suggestions to reform the current system of conducting clinical trials. I found it very difficult to give his suggestions any credence at all since he was very short on express ing remorse for what he had done. While he admitted to being greedy, he spent considerable time lamenting his treatment in prison (lousy food, sleep deprivation, strip searches, and menial work) instead of expressing sorrow to the institu tions and pharmaceutical companies that he defrauded or to the research subjects that he endangered. He also denied committing bribery and some other crimes to which he pled guilty. I came away from his presentation with the distinct impression that Mr. Diamond had learned very few lessons from his own greed. Paul Below CLINICAL RESEARCH CONSULTANT P. BELOW CONSULTING INC. Cheaper Drugs Today, But Fewer Medicines Tomorrow The vote by the U.S. House to allow the reimportation of drugs from foreign countries spells disaster for the future of pharmaceutical development. Thedrugs developed by U.S. phar maceutical companies are in demand around the world, but that means they’re also often at the mercy of governments with socialized medicine systems that have the power to force U.S. com panies to sell their products at belowmarket prices. By reimporting the same drugs back in the United States, we’re essentially reimporting their entire drug pricecontrol system, which would be a disaster. If enacted, this bill will make maintaining a viable drug industry even more difficult, since it is U.S. consumers who end up making possible the development of new drugs for everyone by paying prices high enough to support the research that is required to bring drugs to the market. A more effective way to reduce costs would be to reform the FDA’s drugapproval process, which weighs heavily the risks of approving a drug too quickly, but gives little weight to the risks of approving a drug too slow ly. The result is the druglag problem, increasing the cost of getting a new medicine to pharmacy shelves. Fred L. Smith Jr. PRESIDENT COMPETITIVE ENTERPRISE INSTITUTE “I challenge Mr.Diamond’s assertion that he and Dr.Borison did not risk the health of patients.” — Paul Below CLINICAL RESEARCH CONSULTANT, P. BELOW CONSULTING INC. AWESOME STATISTICS — WHAT HAVE YOU HEARD LATELY? The lifesciences industry is data driven. As such, executives encounter statistics on a daily basis that have the potential to impact their strategies. PharmaVOICE wants to know what are the most sur prising statistics or strange facts that you have come across lately. For example, did you know that every human spent about half an hour as a single cell? Or, that about 70% (of 10,000 sur veyed) of consumers think companies have too much per sonal information, and 76.4% feel that their privacy has been compromised if a company uses their personal information to sell them products. WHAT’SYOUR OPINION? Please email your comments to email@example.com. What’s Your Opinion? LETTERS Patients at risk