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(NaturalNews) In yet another example of pharmaceutical hubris, Biopure has ballyhooed a study it financed, claiming it shows that their product is successful and safe. Reading the study itself, though, shows a completely different result:

* The death rate was 1-2/3 times higher in those who received artificial blood.

* Adverse events were 1-1/2 times higher in those who received artificial blood.

* Serious adverse events were 1-2/5 times higher in those who received artificial blood.

* Double the number of heart attacks occurred in those who received artificial blood.

* The number of strokes cannot be given a statistical outcome, because six people who received artificial blood had strokes, while there were no strokes in the control group.

Are your eyes spinning? Is your mouth hanging open in shock? Do you think there must have been a misprint? Is it possible that 1-2/3 more deaths, double the number of heart attacks, an infinitely higher rate of strokes, and more adverse events can be considered successful?

The answer, when you're a pharmaceutical corporation trying to make profits, is an unequivocal yes. Biopure is trying to get Hemopure, a hemoglobin-based oxygen carrier (HBOC) intended to replace blood in transfusions, approved for sale. To this end, on June 10th, it produced a press release quoting the company's medical vice president, Dr. A. Gerson Greenburg, as saying, "It is gratifying to have experts cull through the complex data repeatedly until insight into our product emerged."

If you translate that statement, what you have is a claim that even the worst results can be ignored in favor of a carefully defined definition of success that fits a portion of the data.

My Approach to the Study

As a result of my recent Natural News article, "Disaster Results From Artificial Blood Testing on Unsuspecting People" (http://www.naturalnews.com/023353.html) , I was included in mailings by Biopure. The first complained of the Natanson study referenced in the article, claiming that it was a "poorly constructed meta-analysis predicated on the hypothesis of an increased mortality".

The author, A. Gerson Greenburg, MD, Vice President of Medical Affairs, further stated, "In my opinion, it would be in the best interest of science and the field that both publications be formally retracted from the literature and an apology issued for being inaccurate, erroneous, incorrect, improper and unjust." Strong words!

Biopure has sent out notices of a new trial of their artificial blood product, Hemopure. They quickly blanketed the online finance world with notifications of it and claims of both its efficacy and safety. The same article, word-for-word, appeared on sites all over the 'net.

My approach was different. I looked for the study itself. Unable to find it, I contacted Biopure and asked for a copy. Within ten minutes, I had it. Unlike all those publications and their so-called reporters, who simply took the word of the pharmaceutical company and printed what they sent without a second look, I have read and carefully reviewed the study itself

So, you can be among the first to know what the study actually says.

Conflicts of Interest

The study, "HBOC-201 as an Alternative to Blood Transfusion: Efficacy and Safety Evaluation in a Multicenter Phase III Trial in Elective Orthopedic Surgery" was published in the June issue of the Journal of Trauma. (HBOC is an acronym for hemoglobin based oxygen carrier.)

One of the authors is Greenburg, Biopure's medical vice president. The lead author is Jonathan S. Jahr, MD. As a stockholder in Biopure, Jahr has a financial interest in the results of the study. He has previously published a study that withheld data showing negative results.

In 2004, a lawsuit was filed against Biopure for misleading investors for misrepresenting Hemopure's safety after it knew that the FDA had misgivings about it. They settled out of court. Several other class action suits have been filed against Biopure.

How can results like these be reported as successful?

Different techniques were used to obfuscate the recent trial's results:

* Implying that, because it was already known that the product causes certain adverse events, then those particular effects could be ignored as not relevant.

* Specifying success as avoidance of real blood transfusion in a certain percentage of cases, ignoring negative results in patients.

* Identifying the subset of patients with the worst results and placing the blame on their characteristics.

Study Methodology

The Subjects

Orthopedic patients having a wide range of surgeries were used in the study of Biopure's HBOC as the subjects. There were 693 subjects in 46 locations around the world, including the U.S., Europe, Canada, and South Africa. 350 were in the HBOC (artificial blood) group, and 338 were in the packed red blood cell (PRBC) control group. Types of surgery were all related to the skeletal joint system. 304 of the HBOC group and 282 of the PRBC group underwent non-back surgery. 46 of the HBOC group and 48 of the PRBC group underwent back surgery.

The trial ran for six weeks. There was no long term follow-up.

Reasons for doing HBOC or PRBC infusions included:

* Heart rate over 100 beats per minute

* Low systolic blood pressure

* Evidence of myocardial ischemia in an ECG

* Acidosis

* Blood loss over 7 milliliters/kilogram

* Diminished urine output less than 0.5 milliliters/kilogram/hour

* Weakness or dizziness

The Study

If certain criteria were met, those who had been given HBOC (artificial blood) were given PRBC (real blood). These were patients whose condition was not being adequately helped by HBOC. Thus, the goal of the study was to limit the percentage of cases in which PRBC was required. Success was defined as avoiding PRBC infusion in 35% of subjects. The study reports that over 50% of the HBOC group were able to avoid PRBC infusions. This is the basis of the claim for success.

Subjects deemed to require a transfusion were given either HBOC or PRBC by randomization. Some patients who were started on HBOC were later switched to PRBC "based on the investigator's assessment of clinical need," according to the study. How this determination was made was not discussed, though it was claimed that "contemporary transfusion process" was adhered to.

Each of the two groups of subjects were divided into two more groups. Those who were given HBOC (artificial blood) were divided according to whether they were switched to PRBC. Those who were given PRBC only were divided according to whether they were given two or fewer units of blood or three or more units.

Subjects who were started on HBOC and never received PRBC were considered moderate risk. Those who were started on PRBC and received fewer than three units were also considered moderate risk. Those who were started on HBOC and switched to PRBC were considered high risk. Those who were started on PRBC and received three or more units were considered high risk.

Several markers for health were tracked in the subjects. These include creatinine, hemoglobin levels, systolic blood pressure, lipase, and liver function tests. There was discussion about whether adverse events were associated with various test results. HBOC had a negative impact on all these markers. Positive or negative, they do not have any bearing on the claim of efficacy for Biopure's artificial blood, though they may be indicative of why there were so many more adverse events with it.

Results

Results from the four groups were discussed extensively in the study report. The study stated that nearly all of the negative results were in the high risk groups. This is hardly surprising, especially in light of the fact that the results of the study determined which subjects were classed as high risk.

Being switched from HBOC to PRBC, or being given more than two transfusions in those started on PRBC, were the only determinants of high risk classification. There is no way to identify high risk, other than by treatment. Thus, this separation into smaller groups accomplishes nothing but obfuscation.

The authors identified those at greatest risk as being over age 80. They make this claim based on 43% of cardiac severe adverse events and half of the deaths being in this group, though they are only 9% of the total number of subjects. While this is interesting, it does not include all adverse events.

Were those who suffered strokes the same age, or were they, perhaps, two decades younger? That information is not provided. So, very little can be concluded about the relative risk of artificial blood based on age.

Yes, it's interesting that 43% of severe cardiac events were among people over age 80. However, the ages of the rest of the subjects who suffered from cardiac events is not noted. Neither are the ages of the stroke victims given. Nor the ages associated with any other adverse events. In fact, what is most notable here is the lack of information provided.

The authors state:

"There are a number of physiologic effects of HBOC-201 that are known and expected for this class of drugs... removal of these expected AEs [adverse events] reduced the difference between matching groups... and clearly accounted for the majority of the differences between groups."

From a patient's point of view -- and, one would hope, that of a doctor -- the fact that adverse events are known to occur in a class of drugs does not eliminate them from concern.

The authors blame over and under treatment for a large portion of adverse events. What determines whether a patient has been over or under treated is not defined, making it a questionable piece of information.

The authors show a significant decrease in the use of their artificial blood product. They don't, though, state what basis, other than "contemporary transfusion process" was used to determine when or why real blood needed to be used instead.

Implications

If those who are at high risk could be identified before being subjected to artificial blood, then the study might be considered successful. However, the only determinants for high risk were the results of the study -- those who required a switch from HBOC to PRBC or those who required three or more units of PRBC. So, the bottom line for any potential patient is whether there is greater risk from artificial blood than real blood. The answer to that was quite clearly delineated by the study. Yes, severe risks, including death, are greatly increased by Biopure's product, Hemopure.

No amount of obfuscation or discussion of whether a patient was medium or high risk changes that fact. From the point of view of most patients, success is not measured by whether real blood transfusions are avoided. What counts is the likelihood of encountering an adverse event, like heart attack or stroke, or dying. If that risk is greater with Biopure's product, then most patients will not want it used.

References:

"HBOC-201 as an Alternative to Blood Transfusion: Efficacy and Safety Evaluation in a Multicenter Phase III Trial in Elective Orthopedic Surgery", The Journal of Trauma, Jonathan S. Jahr, MD, Colin Mackenzie, MD, L. Bruce Pearce, PhD, Arkadiy Pitman, MS, & A. Gerson Greenburg, MD, PhD

"Artificial Blood: HBOC-201 Does Well in Clinical Trial", Scientific Blogging, (http://www.scientificblogging.com/n...)

Berman DeValerio Pease, Tabacco, Burt & Pucillo, "Biopure Corp.", (http://www.bermanesq.com/Securities...)

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