If people on the board have been following along, Biopure recently announced last week how great their cow's (bovine) blood product (hemoglobin based) is. This is important to the Witness community because this product may save JW lives who are now allowed to take hemoglobin (Of course to non-JWs, we wonder out loud how stored cow's blood is okay when the Watchtower tells the press and JWs that transfusions are not allowed because blood must be poured on the ground).
The company's (Biopure's) upbeat press release occurred after "TheStreet.com" found out problems with Biopure and reported the safety concerns about the hemoglobin from cow's blood product. I provided the board with TheStreet.com's concerns regarding the press release
When I reviewed this recent September 1, 2001 story by TheStreet.com, I wondered if the Watchtower was running this company.
Why you ask?
Anyone who looks at a Watchtower article will note that the Watchtower will do a correct quote from a recognized author but will always take the quote and the author's conclusion completely out of context. (Remember Maximus' essay on Professor Frank Gorman's quote found in the Oct 15, 2000 WT QFR as just one example).
Compare this story, where Adam Feuerstein, the reporter, reveals the company is letting an "independent panel of reviewers" study the patents side affects who take human blood and hemopure. But the company, Biopure, does not reveal to the "independent panel" how "serious" the side effects are!
Also compare how the story also reveals that kidney complications are not a big deal with hemopure according to the company. Only problem is that the story provide doctors who tell us there are no kidney problems with blood transfusions and the rate of kidney problems with hemopure could be deemed too high to be safe compared to blood.
Please note the area where I have both underlined and bolded a paragraph in the story (below). After you read this paragraph, ask yourself, who else do we know that over plays the dangers of human blood eh? (BTW that's a Canadian "eh")
I know Marvin (who I have the most utmost respect for), you told me the science seemed okay. But this story does seem to tell a much different picture on the science never mind all the "spin" being put on by the company.
I express a lot of concern over this information that shows the science appears suspect. The reporter is now quoting actual doctor's names (one who was involved in the hemopure study) and the company is not repsonding to the charges and releasing the data. The JW leadership is relying on this and other products to get them out of this blood transfusion mess and it seems like it won't be happening anytime soon. This at a time when little kids are dying in the JW community all because the leadership does not want to face the lawsuit music.
Please read the article below for yourselves. I think this story is going to get bigger "legs".
hawk
( http://www.thestreet.com/stocks/biotech/10000575.html
Biopure's Safety Claims Leave Some Doctors in DoubtBy Adam Feuerstein
Staff Reporter
09/01/2001 10:00 AM EDTBiotech firm Biopure's (BPUR:Nasdaq - news - commentary) statement Aug. 27 that its highly anticipated blood substitute met safety requirements hasn't closed the book on the product -- it's provoked a whole new series of questions from medical professionals.
Shares of Biopure have risen nearly 13% since the company announced that an analysis of testing data showed its blood substitute Hemopure was essentially no more dangerous for patients in surgery than blood transfusions, an assertion reinforced by the comments of CEO Carl Rausch.
But a closer examination of Rausch's comments and Biopure's explanation of how the safety analysis was conducted tells a different story. Expert physicians doubt statements made by CEO Rausch about the relative safety of blood transfusion. One physician even calls the admitted rate of kidney problems found in Hemopure patients "alarmingly high" and "unacceptable." In addition, reviewers conducting Hemopure's safety analysis were not given access to patient data crucial to making judgments on Hemopure's safety -- information that the company has not made public.
Comments last week by Rausch and a company spokesman about side-effects raised eyebrows about the information Biopure is giving investors. As a quick refresher, TheStreet.com has previously reported on information that at least six patients receiving Hemopure lapsed into temporary kidney failure so serious that dialysis was required.
Biopure has never publicly acknowledged cases of kidney failure. Until last week, that is. In an interview with CBS MarketWatch, Biopure spokesman Doug Sayles said, "There were occurrences of renal failure in both groups, but it was very uncommon." The groups he was referring to are Hemopure patients and those receiving red blood cells.
Representatives of Biopure did not reply to requests for comment from TheStreet.com.
Biopure's CEO Rausch also spoke on the subject in interviews with CNBC and The New York Times, although his terminology was different. The "rate of serious urinary and kidney reactions during the trial was 1% to 2% for both the patients receiving Hemopure and those receiving transfused blood," Rausch told the Times. He made similar comments using the same numbers during a CNBC interview, adding that the rates were "statistically insignificant."
But Rausch's assertions do not gibe with the opinions of several highly credentialed doctors and blood-transfusion specialists. In fact, these experts say that Rausch's claims about the dangers of transfused blood are baseless.
Dr. William Colman, an assistant professor of orthopedic surgery at the University of California San Francisco Medical Center, says that "we transfuse blood into a lot of patients, and when you're dealing with healthy people that need blood, renal failure is never an issue."
Colman specializes in joint replacements, a type of elective orthopedic surgery that was also part of Biopure's late-stage tests for Hemopure. He says it's not uncommon for a small percentage of patients, during or immediately after surgery, to experience some temporary decrease in kidney function. But he stresses that these problems are caused by factors unrelated to blood transfusions. Colman has no financial interest in Biopure or any other blood substitute company.
One of Colman's UCSF colleagues, Dr. Sigurd Berven, agrees, stating that in his eight years as an orthopedic surgeon, he has had only two patients who suffered kidney complications so serious as to require dialysis. But neither patient's problems were caused by blood transfusions.
"The odds of serious renal [kidney] complications occurring is less than one patient in every thousand," he says, adding that blood transfusions actually help to cure these problems. Berven has no financial interest in Biopure or any other blood-substitute company.
Dr. Jeff McCullough, professor of laboratory medicine and pathology at the University of Minnesota, and the editor of Transfusion, the medical journal for blood-transfusion medicine and blood banking, says the only way blood transfusion would cause kidney damage would be if a patient received the wrong type of blood by mistake.
"It would not be expected that even 1% or 2% of patients undergoing orthopedic surgery would have renal complications of any kind due to transfusion," he says. McCullough has no financial interest in Biopure or any other blood substitute company. He does conduct research for Cerus, (CERS:Nasdaq - news - commentary), which is developing a new blood-cleansing system.
And just as alarming to Dr. Berven is Rausch's complementary statement that 1% to 2% of patients receiving Hemopure suffered severe kidney reactions. Berven is currently conducting research on ways to reduce overall blood risks during surgery, so he's knowledgeable about blood substitutes.
"A 1% to 2% [kidney] complication rate among patients getting a blood substitute is dangerously high and is really unacceptable, especially in an orthopedic patient population," he says.
These doctors clearly believe that Rausch's statements about the dangers of transfusing blood during surgery are overblown. If true, they said, it would represent a public health crisis that they believe does not exist.
In some respects, Rausch's comments to reporters last week were not as important to investors as the main event -- the release, after one year of work, of the findings from an independent safety analysis committee convened to pass judgment on Hemopure's safety. It was the company's announcement of positive results from this statistical analysis that sent Biopure shares flying.
"The overall medical risk to patients receiving Hemopure was no worse than the risk to patients receiving blood," Biopure said in its press release.
But a careful examination of this statistical analysis and how it was conducted suggests that this study concluded little or nothing about Hemopure's safety. Instead, it was only powered to determine the "risk" of safety or medical problems cropping up in Hemopure patients, compared with those for patients receiving red blood cells.
This is a complicated, but very important distinction. Risk is defined as the possibility of meeting danger or suffering harm or loss. But calculating risk tells you nothing about the cause of that harm or its severity.
The reviewers who conducted Biopure's safety analysis were given a medical report on each patient, "including adverse and serious adverse experiences," according to an explanation of the study's design included in the company's Aug. 27 press release.
But later in the release, the company says that the same reviewers were not given a crucial piece of information. They were barred from "the treating physicians' classification of the seriousness, identity and cause of the reported adverse experiences."
In other words, Biopure says its independent panel of reviewers was asked to determine whether Hemopure was safe, based on patients' records that included a list of all negative side-effects associated with the blood substitute and transfused blood. But omitted from these patient records was any information on the cause or seriousness of the negative side-effects.
Given the information provided, reviewers could only add up the number of adverse events in each group, and use those figures to calculate the overall medical risk posed to patients receiving Hemopure vs. patients receiving blood. Determining the causal link between Hemopure and reported side-effects -- the actual safety of the product -- was not possible.
Biopure has yet to do what many other biotech firms do -- make public actual testing data to support its conclusions and hold a telephone conference call or meeting in which analysts and other biotech observers can ask questions. In fact, Biopure has never presented any of its late-stage Hemopure test data for peer review or discussion at a scientific or medical conference, despite the company's claims that it will file an approval application with the FDA by the end of the year.