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By Judith Graham
VA Extends New Hepatitis C Drugs to All Veterans in Its Health System

 
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Dr. Raymond Schinazi played a leading role developing a drug that cures hepatitis C while working seven-eighths of his time for the VA
 
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Hepatitis C drug costing VA, DoD millions
By Patricia Kime, Staff writer
We're looking at a company who is milking a cash cow for everything it's worth," Sanders said. 
 


VA to outsource care for 180,000 vets with hepatitis C
Dennis Wagner, The Arizona Republic 12:27 a.m. EDT June 21, 2015
 


VA to outsource care for 180,000 vets with hepatitis C
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Dr. David Ross, the VA's director public-health pathogens programs, resigned from the working group. "I cannot in good conscience continue to work on a plan for rationing care to veterans," he wrote.
 


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1976 Maclean’s Magazine December 27,1976 Health

Blood money: what Red Cross donors didn’t know

A bitter behind-the-scenes struggle between two of Canada’s most respected organizations is about to break into the open, bringing with it at least some of the sordid details of a murky world — the $400-million-a-year international trade in human blood.

The Canadian Red Cross Society and Connaught Laboratories of Toronto, which have been closely associated for decades, are in hot dispute over which of them should process the blood plasma the Red Cross collects from volunteer donors across the country. It is a job Connaught has always done.

The falling-out stems from a little-known 13-year agreement under which Connaught exported nearly seven million dollars worth of surplus blood components and turned over 10% of the proceeds to the Red Cross, an organization that publicly insists that human blood should neither be bought nor sold.

The Red Cross angrily contends that at the end of 1973 Connaught exported $200,000 worth of serum albumin (a component processed from plasma and used to treat burn victims) at a time when Canadian hospitals were desperately short of the material. Connaught denies the contention and claims Red cross officials had approved the exports.

Now the Red Cross wants to sever its relationship with Connaught, and has asked the federal and provincial to support its plan to build a $10-million-plus fractionation (plasma processing) plant which would be owned and operaed by the Red Cross itself. Such a plant would severely undermine Connaught’s already shaky financial position. Canada’s 11 governments must adjudicate, despite their close association with both parties (the Red Cross transfusion service receives $30-million a year from Ottawa and the provinces; Connaught is indirectly controlled by the federal government, through the Canada Development Corporation).

Neither party has been anxious for the dispute to become public knowledge. Connaught has recently encountered serious criticism on several fronts, and is jittery about its relations with the press.

The Red Cross, fearful of offending those Canadians who donate their blood (only 4% of the public contributes the million pints the Red Cross collects annually), is equally wary of controversy. "Every time, we lose donors," says Red Cross medical director Dr. Roger Perrault. But Perrault believes Connaught is no longer acceptable as the processor of the nations’ plasma, and has taken his case to the various health minisistries.

Connaught on the other hand, vows to fight the Red Cross plan with all the resources it can muster. "We don’t believe it makes economic sense," says Alan Davies, the 36-year-old executive vice-president who is running Connaught on an interim basis. "Why should the taxpayer be asked to underwrite a new plant when we have a perfectly acceptable one here."

The Perrault proposal, however, received tacit support at special meeting of federal and provincial representatives in Ottawa November 23. That meeting agreed to let the Red Cross begin a feasibility study for its project, although, as Perrault says, "so far we have nothing on paper."

The Ottawa decision was based in part on a Red Cross document that outlined why the society wanted to end its relationship with Connaught. The document contained many details that cast a disturbing light on how Canada’s blood program has been operating. It showed for instance, that donated blood components worth $6,898,274 have been sold overseas since 1963. It revealed that roughly 40% of a blood fraction regularly sent by the Red Cross for processing by Connaught never returned because of contamination. It claimed that the Red Cross is now paying Connaught double what blood processing would cost from foreign fractionators. And it charged that Connaught had been miserly in spending on technical improvements and research.

Davies says the Red Cross submission was less than valid. "A lot of the Red Cross allegations are a year and a half out of date ... we have to be terribly honest about this. There was a time when we were having troubles with contamination, when our yields were perhaps low ... But we have made substantial improvements and I think I can say that our yields today compare favorably with the best fractionators in the world." He was distressed when told that Perrault had said: "I believe that in the long term our differences are irreconcilable."

Replied Davies: "I do not accept that. I cannot. Because if I accept that I’m saying essentially that Connaught is not as interested in health care as the Red Cross is ... I think Connaught more than most companies, has made a commitment to health care."

The story of the Red Cross disillusionment with Connaught has been long in the making, inextricably mixed with the history of the national blood transfusion service itself. The service began amid high hopes January 21, 1947, when the Red Cross opened its first blood donor centre in Vancouver. The original aim of the program was to eliminate commercialism. Although commercial blood cost as much as $25 a pint, the introduction of a voluntary donor service was not entirely based on financial grounds. Statistics showed then, as now, that commercial blood carried a far higher risk of disease than volunteered blood.

By 1954 the question of processing an ever-increasing flow had to be settled. Connaught, then a University of Toronto facility, was a research and manufacturing institute which had been set up in 1914 to manufacture vaccines and sera. The discover of insulin by the University of Toronto’s Frederick Banting and Charles best in 1921, and its subsequent production gave Connaught a well-deserved international reputation.

Connaught had produced dried blood plasma during the Second world war and had continued to process components into the 1950s, so it was well prepared to meet Red Cross needs by setting up a fractionation plant in 1954. (Fractionation is the process of splitting plasma into components that serve the same purpose a whole blood in transfusion.)

The Red Cross medical director at the time was D. George Miller. He established the arrangements, which involved sending Red Cross plasma to Connaught after the red cells had been removed. Connaught then broke down the plasma into components which were returned to the Red Cross for distribution to Canadian hospitals. For years, the arrangement worked well — so well, in fact, that the Red Cross decided in 1963 to sign "a gentleman’s agreement" with Connaught for plasma work. It contained the seeds of the current dispute. While blood technology in the rest of the world was fast improving, Connaught’s plant was beginning to age, it’s renowned flair for research fading.

But the Red Cross went further than merely initiating an agreement on plasma production. For 10% of the proceeds, it agreed to let Connaught sell certain blood components taken from the Red Cross donors. According to Miller, the Red Cross board made the decision on the assumption that the material would otherwise be dumped.

For 13 years, this agreement was never publicly disclosed or even referred to in the annual reports of either organization, although the sums involved were substantial. According to the Red Cross, Connaught received $6,898,274 from selling blood components. The Red cross share was $689,824.

Connaught sold some of the plasma derivatives through its contacts. It also used a Montreal broker named Thomas Hecht, who ran a company called Continental Pharma. His relationship with Connaught began in the late 1950s when he sold Salk polio vaccine for the institute. In a recent telephone interview, he said that his formal relationship with Connaught ended in the early 1960s, although he continued to sell blood components from Connaught on an irregular basis into the 1970s. During this period the world demand for blood was rising — particularly in Europe. The large drug companies there could not get enough suitable plasma because most European blood-donor systems were voluntary. Private brokers began scouring the world for blood, buying it anywhere they could, frequently from commercial "bleeding" operations exploiting the poor in Latin America. both the International Red cross and the World Health Organization have denounced this trade.

By 1971, Hecht had made a number of sales for Connaught in Europe. He was also involved in the selling of blood plasma not only to Europe but also to the United States. For example, one of his executives, Victor Kubik, offered large amounts of plasma to Warner-Lambert, the U.S. pharmaceutical giant. Kubik protected the source of this plasma by saying that it would not be identified by bleeding lists. Normally, such lists are provided to show who the donors were and where the plasma was drawn.

Miller says the plasma Hecht had on offer would not have come from Red cross donations. But, according to the Red Cross document presented in Ottawa, the Red Cross would not have known if it had because "no guarantee was ever given to the Red Cross, nor was any audit ever made available from Connaught to ensure that all sales were indeed credited." Connaught, which says it no longer does any business with Hecht, flatly denies ever selling any whole plasma obtained from the Red Cross. And the Red Cross says it has no reason to believe otherwise.

Nevertheless, it was the issue of whether Connaught was selling blood components abroad without the knowledge of the Red Cross that caused the first dispute. In early 1974, shortly after he had taken over from the retiring Miller, Perrault discovered that serum albumin was being sold abroad by Connaught.

The discovery came when Perrault received two cheques totaling $20,000 from Connaught. When he asked what the cheques were for, he was told that they represented the Red Cross’ share of albumin sales, under the long-standing agreement.

Perrault knew of no such agreement. What he knew he says was that there was an acute shortage of albumin in Canada. He demanded that Connaught stop exporting immediately, and Connaught complied.

Today Connaught claims that, at the time the sales in question were proposed and approved there was no shortage, but that soon afterward one developed because of a mysterious failure ("It was a freak thing, we can’t explain it." says Davies) Perault, on the other hand, insists there already was a shortage that simply became more severe when Connaught experienced the sequential batch failures. Either way, suspicion began to replace the traditional trust.

Connaught’s regular marketing of Red Cross blood components between 1963 and 1972 had not saved the company form its financial troubles. (Last year it lost $1.5 million on sales of $18 million.) And while the Canada Development Corporation’s take-over was partially a life belt operation, Connaught’s mandate was clear: it had to become profitable — fast.

The CDC recruited and ex-Warner-Lambert executive, Donald McCaskill as Connaught president. McCaskill was under immediate pressure. Not only had he to make profits with limited means, but he was saddled with contamination problems.

Connaught processing was infecting the plasma passing through its plant with toxins called pyrogens. These toxins produce fever when injected into humans. Pyrogenic plasma is regarded in medical circles as unfit for human use.

The pyrogenic problem at Connaught had an alarming effect on its production of pure blood components. A Red Cross survey showed that out of 644,745 vials of albumin due from Connaught over a 13-year period, fully 250,682 were 'lost' because of contamination.

In fact, the missing blood fraction was not lost.

Much of it was stored on the shelves at Connaught, which put forward two explanations. McCaskill said, in a 1974 letter to the Red Cross, that the "product was discarded, written off in value, but through some unknown set of circumstances, the physical product was retained." Davies says now that the "blood department put it away, knowing that some day it would be valuable."

In the summer of 1973, Connaught’s scientists began working on a process of removing pyrogens from the tainted albumin. There were able to do this, but there was disagreement in medico-scientific circles as to whether de-pyrogenated blood products were fit for human use.

A former vice-president of research for Connaught, Dr. Andrew Moriarity, has said: "You can interfere with other parts of the plasma while removing the pyrogens. It may pass tests afterward, but you could have other faults as a result."

"Despite such reservations Connaught produced a new process within three months. It made a confidential submission of samples of de-pyrogenated albumin to Ottawa’s Bureau of Biologics October 19, 1973, citing the general shortage of albumin.

On December 4, Ottawa replied. Of the three lots submitted for testing, the assistant director of the bureau, J.L.Byrne, wrote, two were pyrogenic, whereas your (Connaught’s) findings were the opposite."

On a controversial process that no other country then licensed, one third of Connaught’s sample had failed to pass.

Yet Ottawa decided to release the re-processed albumin for human use, providing it not be released on the Canadian market without Ottawa approval. While this injunction was obviously intended to protect Canadians, it placed no barrier on Connaught exporting the material.

Thirteen days after receiving the bureau’s letter, Connaught was shipping the reprocessed albumin abroad. The documents accompanying the exports contained no hint that the albumin was re-processed. Otherwise it likely would have been rejected by the importing country, which turned out to be Spain.

It was at this point that Dr. Perrault first took office, amid growing albumin crisis in Canada. "I was getting angry phone calls and letters from our 16 distribution centres," he said. "I finally wrote back assuring our people that I wasn’t hoarding the stuff."

Perrault, a University of Ottawa medical graduate with a Swedish PhD in blood research, knew nothing of Connaught’s exports when he took office. After he found out, while grappling with a shortage in Canada, he blew up. On April 9, 1974, he had a confrontation with McCaskill. The following day McCaskill wrote to Perrault saying that in the previous November, Miller had agreed to export the albumin and that neither of them would have allowed it to happen had there been a shortage. In fact, the shortage for the month of November was critical — with the Red Cross able to fill only 884 out of 2,222 orders received. Miller today says he has no recollection of the matter.

With the exports halted, Connaught’s de-pyrogenated albumin began to move into Canadian hospitals through the Red Cross, always after being released by Ottawa’s Bureau of Biologics.

According to an abnormal increase in patient reactions during the three years in which treated albumin has been used in Canada, Connaught says it regards its process as potentially very valuable, and says it has so far refrained from publishing details because its process cannot be patented. "We are hoping to effect an exchange of technology with another company," Davies says.

Connaught also claims to be the only blood fractionator in the world with a government license to distribute de-pyrogenated material. The license, really a letter from Ottawa’s bureau of Biologics, requires that Ottawa clear each batch as Connaught produces it. In fact, the U.S. Bureau of Biolgics occasionally releases for distribution material that has been de-pyrogenated by U.S. fractionators. "But," says Dr. Hohn Finlayson of Bethesda, Maryland, "we would naturally prefer that the processors avoid contaminating the product in the first place."

Today Connaught claims it has largely overcome its contamination problems and is efficient as any fractionator. But Perrault and the Red Cross are determined to go their own way. Even if the Red cross wins government approval for its own plant, such a facility is at least six years away. In the meantime Perrault and the Red Cross have to deal with Connaught, or take the politically sensitive step of sending their plasma out of the country for processing. "I have three offers from foreign fractionators to do our work at roughly half what we’re paying Connaught," Perrault says.

Despite their differences, Davies and Perrault are in the midst of negotiating a formal contract to replace the old "gentlemen’s understanding." Perrault abrogated the 1963 agreement last March, and Davies agrees that it was the right thing to do "We want to get on a more business-like basis," Davies says.

Perrault adds: "I hope to negotiate a standard fractionation contract, one that would guarantee performance [yields] and prices." Perrault also admits that he wants to increase the Red Cross’s share of the proceeds from any foreign sales of surplus blood products. "I don’t think the 90:10 split was very fair," he says. "Connaught was recovering far more that its costs, while were were recovering far less." Davies says Perrault now wants 50% of the foreign proceeds.

It all seems strange, given Connaught’s chronic problems (the Canadian Medical Association has sent a five-member team to study the company’s operation and the team’s report is expected to be published in the association’s journal next month) and given the Red Cross’s stock position that blood is too precious to be bought or sold.

But Perrault denies there is any inconsistency. "I want to protect the volunteer donor system," he says. "I will do anything to improve it. It doesn’t have to be done by the Red Cross, you know. If Colgate-Palmolive can organize it better, fine... But right now in Canada, our blood transfusion system is based on volunteer donors and public funds. There is no room for the profit motive. And yet the profit motive is very much in evidence. At Connaught. You’re not supposed to make a profit on plasma, but the CDC is under orders to make a profit. Obviously a fundamental policy decision will have to be made."

Joseph MacAnthony