Eden: Biopure went bankrupt because Hemopure stalled at clinical trials on humans, and they ran out of money. Their assets were then purchased by OPK Biotech. Seemingly small detail, but very relevant.
Yes. And it was then that OPK, I believe pulled up stakes and moved to Russia. And then, came back to American soil. Something like that...it is a difficult company to track. Consider how the WTS used the lure of having over 3000 doctors all lined up and ready to make medical advances using the JWs in Russia, as an argument to present to the Russian Supreme Court. The JWs were presented, not just as a religion, but also as a medical research group.
But, to throw some more interesting history of Hemopure into this mess, there is a whole scandalous legal drama that went on with Biopure over those stalled human trials. What happened was that the FDA had asked for the results of the clinical trials that were being conducted but Biopure refused to hand over the results. . And, subsequently, the investors sued Biopure.
http://www.dailykos.com/story/2009/03/14/708377/-Big-Pharma-CO-Fakes-Cancer-Doctor-Fakes-Clinical-Trials-for-Vioxx-Celebrex#
Howard Richman, former VP of Biopure, impersonated a doctor and lied about having colon cancer in order to trick a judge into thinking he was suffering and dying.
This bizarre deceit was an effort by Richman to squirm out of an SEC lawsuit that accused Richman of misleading investors. According to the Associated Press, Richman misled investors about the potential for FDA approval of a blood replacement product called Hemopure, which is made from cow's blood. By faking his own cancer and forging a doctor's note, Richman was able to get a postponement of judgment in the SEC lawsuit, which effectively ended the legal action he would have otherwise faced.
Richman was sentenced to three years in jail in 2009:
http://www.cbsnews.com/news/biopure-exec-sentenced-to-three-years-for-faking-cancer-to-avoid-sec-probe/
Howard Richman better hope there's no such thing as karma. The formerBioPure vice president was sentenced last month to three years in prison for faking cancer to avoid an SEC investigation.
The investigation centered on BioPure's communications with investors regarding Hemopure, a bovine-derived blood substitute. The product gained approval in South Africa but was turned down by the FDA in 2003. At the time, BioPure characterized the agency's rejection as relatively positive given that new clinical trials were not required, and the stock jumped 20 percent.
Apparently, BioPure failed to mention that the FDA had raised safety concerns about Hemopure and placed a clinical hold on other trials. According to the Boston Globe, that information was omitted from SEC filings as BioPure raised some $35 million that year, triggering the wrath of an SEC already fed-up with biotech hype.
And that's when Richman had an inexplicable lapse in judgment. According to the Globe:
Thomas Moore, the former chief executive, agreed to pay a $120,000 settlement. The company settled without paying a fine the year before. Jane Kober, Biopure's general counsel, and Carl Rausch, its former vice chairman and senior technology officer, each paid $40,000 fines. Richman was the only person who contested a settlement at that time.
As the SEC tried to proceed with its case, Richman said he had colon cancer and couldn't participate in depositions and such. He submitted a fake doctor's note and impersonated his doctor in a phone call with his lawyer. As time went on, he claimed the cancer had spread and was terminal, and a judge ended the litigation against him.
But later that year, Richman's lawyers abruptly resigned (hmmm--wonder why) and his new lawyers came clean to the judge. He pleaded guilty to one count of obstruction of justice in March, and in October he was sentenced to three years in prison.
BioPure wouldn't talk about the issue with the Globe, distancing itself by saying Richman hadn't worked there for years. But the company is not exactly free and clear of questionable judgment calls: Last year it filed a lawsuit against an NIH researcher who had published an unfavorable article about Hemopure in theJournal of the American Medical Association and pushed for the product's withdrawal in South Africa. Trying to sue a scientist for publishing data that shows your product is unsafe may not be as bad as faking cancer, but it ain't good.
BioPure filed for Chapter 11 bankruptcy in July.
The Securties and Exchange Commission laid charges of concealing info from investors against Carl Rauschin in 2003, who was apparently the "inventor" of Hemopure and the founder of Biopure (I think).
https://www.sec.gov/litigation/complaints/2006/comp19651.pdf
Carl Rausch resigned from Biopure in 2005.
For more links and info on Carl Rausch and Biopure lawsuits:
http://www.prnewswire.com/news-releases/biopure-announces-resignation-of-carl-rausch-from-board-of-directors-and-chief-technology-officer-position-54714262.html
*to add - This is why the human trials were stalled:
From a 2002 article:
The Food and Drug Administration is currently reviewing Hemopure as a possible substitute for red blood cell transfusions in patients undergoing orthopedic surgery. A decision on the product's approval is expected in the middle of next year.
Biopure concluded a 688-patient pivotal clinical study of Hemopure in August 2000. The company has insisted that results of this trial showed the product to be safe and effective, but has never fully released data from the study to back up its claims.
Wednesday, safety data finally released from that study showed 118 serious adverse events in 350 patients receiving Hemopure. By comparison, there were 83 serious adverse events in 338 patients given red blood cells.
Eighty-eight patients, or 25%, given Hemopure during the study experienced at least one serious adverse event. That compares to the reporting of at least one serious adverse event in 59 patients, or 17.5%, receiving red blood cells. The difference between the two patient groups was statistically significant, according to the study.
Breaking down these adverse events, 22 patients in the Hemopure arm of the study fell victim to cardiac problems, compared to eight patients in the red blood cell arm.
There were six incidents of kidney problems, including four cases of acute renal failure, in the Hemopure arm. In the red blood cell arm, there were four incidents of kidney problems, including two cases of acute renal failure. TheStreet.com has reported previously on cases of acute renal failure in Hemopure patients.
