Ancient history [15 years old], dirty laundry and an interesting story from "The Scientist" on Biotech's Baddies... Okay it is their issue for 1 April, but they don't do April Fools do they?
the-scientist.com
A former oncologist and his wife, a nurse, almost got away with a fraud that would have made them and an early-stage drug company millions of dollars by placing a largely ineffective topical treatment on the market. But a mistake committed by the oncologist, Harry Snyder, sealed their fate.
In the early 1990s, Snyder was vice president of clinical development at BioCryst Pharmaceuticals, a company based in Alabama; Renee Peugeot, his wife, was a registered nurse at the University of Alabama at Birmingham (UAB). In 1994, BioCryst's only drug, BCX-34, was in early FDA clinical trials for the treatment of psoriasis and cutaneous T-cell lymphoma, a rare form of skin cancer. BCX-34 is a phosphorylase inhibitor that researchers hoped would inhibit T cells, which play a role in both psoriasis and T-cell lymphoma.
At the urging of BioCryst executives, Peugeot was hired to work on the BCX-34 cancer trial at UAB, and she eventually oversaw much of the research involving the drug.
Though the trial was designed to be double-blind, court documents show that Snyder, previously a viral oncologist at Cornell University and author of dozens of scientific papers from the 1970s through the 1990s, started alerting colleagues that BCX-34 was looking like a successful cancer treatment a full month before the studies were completed. He and Peugeot also bought additional shares in BioCryst before the trial ended. Eventually the couple owned company stock and options worth $600,000.
At the end of the trial, data suggested that BCX-34 was an effective treatment in the study's 22 T-cell lymphoma patients at UAB (there were some patients being treated at Washington University in St. Louis). In February 1995, BioCryst issued a press release trumpeting the effectiveness of the drug against both psoriasis and the deadly skin cancer, and informed the FDA that 59 percent of the trial participants either saw their cancer disappear or improve markedly.
BioCryst stock shot through the roof. One share in the company was worth $6 at the end of the trial, and almost $13 only months later. Investors sank millions of dollars into BioCryst and its new cancer blockbuster.
Then BioCryst's medical director and Snyder's superior, William Cook, started writing up the psoriasis arm of the trial for publication, and noticed some irregularities. He found that Snyder had altered the randomization schedule for both trials; reanalyzing the data using the original randomization schedule from the study coordinator, Cook found that only 30 percent of the trial patients who received BCX-34 experienced a benefit from the drug.
In June, BioCryst held an executive meeting and announced what Cook had uncovered. Snyder attempted to justify the discrepancy, to no avail. The company alerted the FDA and issued a press release saying that BCX-34 was not a miracle cure for cancer. The bottom fell out of BioCryst stocks. Investors ended up losing about $34 million.
At trial, prosecutors revealed that Peugeot had participated in the scheme by fudging clinical data in her direct interactions with patients, while Snyder forged a randomization schedule to make it appear that the people who showed improvements in their disorders were also the ones treated with BCX-34. "What made it work so perfectly was that they were on both sides of the double-blind study," says Adolph Dean, a former Assistant US Attorney and one of the prosecutors in Snyder and Peugeot's case. "She was a subinvestigator for the principal investigator and he was working at the company that was conducting the study. They were playing Russian roulette with people's lives."
After a short trial in which the jury took only 3 hours and 35 minutes to deliberate, according to Dean, Harry Snyder and Renee Peugeot were found guilty of mail fraud, conspiracy to defraud the United States, and making false statements to the FDA. Snyder was sentenced to approximately 3 years in prison and Peugeot to 2.5 years. They were permanently debarred from the FDA in January of 2003.
BioCryst declined to comment on the episode involving BCX-34, Snyder, and Peugeot. The duo filed for chapter 7 bankruptcy from jail in 2003. Snyder was released from prison in September 2006, and Peugeot was released in October of 2008.
According to Dean, the pair lives near San Antonio, TX, but phone calls to a Boerne, TX (roughly 30 miles from San Antonio) number registered to Harry W. Snyder, Jr., were not returned. |
