Friday, April 4, 2008

Canadian Government Drops Remaining Charges Against Former Red Cross Director

Nearly two years after the criminal trial first began on February 2006, prosecutors for the Canadian government have dropped all remaining charges against Roger Perrault, former director of the Canadian Red Cross (CRC). The charges stem from Canada’s contaminated blood scandals of the 1980s and early 1990s.
Approximately 1,000 Canadians were infected with HIV and an additional 20,000 with hepatitis C (HCV) when they inadvertently used contaminated blood and blood products. The majority of the HIV infections occurred in the 1980s, while the HCV infections occurred from the 1970s to the early 1990s. Complications related to HIV and HCV have resulted in the deaths of at least 3,000 Canadians.
In May 2005, CRC pled guilty to federal charges filed in 2002 under Canada’s Food and Drug Act for distributing products tainted with HIV and HCV from 1983 to 1990. It paid the maximum fine allowed under the offense. In addition, CRC agreed to contribute 1.5 million Canadian dollars ($1.4 million) to the University of Ottawa; with half the money going to a scholarship fund for victims and their families and the other half to a “national medical error project” to prevent such a crisis in the future.
In 1998, the Canadian government established a one billion Canadian dollars ($970 million) trust for HCV victims. The fund, initially open only to those infected with HCV from 1986-1990, was expanded in 2006 to include all Canadian citizens who contracted HCV from contaminated blood or blood-derived products.
While the compensation packages were welcome developments, the existing charges against Perrault represented for many a chance for accountability. Instead, Perrault’s “exoneration” is difficult for victims and their advocates to accept. They hold the former CRC blood transfusion service director largely responsible for allowing contaminated blood products to infect patients in the 1980s and early 1990s.
Also acquited in that decision were John Furesz, former director of the Bureau of Biologics at Health Canada; Wark Boucher, former chief of the blood products division of the Bureau of Biologics; Michael Rodell, former Armour Pharmaceutical vice president; and Armour Pharmaceutical, the New Jersey-based manufacturer of Factorate, the factor VIII product sold in Canada. In November 1987, Armour withdrew Factorate from the Canadian market in response to evidence that the heat-based, viral inactivation process being used did not adequately kill HIV.
The Canadian Hemophilia Society (CHS), which represents the country’s bleeding disorders population, reacted to the government’s latest move with indignation.
“A lot of money and time was spent and it all just ended today with a 10-minute speech from the Crown,” said John Plater of CHS. “There are a lot of people out there that are hurting as a result of what happened and they are going to walk away from this very confused, very upset, with a lot of questions. People can say that the system has failed them once again.”
Source: The Toronto Star (online), January 19, 2008, and Medical News Today, January 24, 2008

Japanese Victims of HCV Blood Scandal To Receive Compensation

New legislation in Japan will require the government and manufacturers of hepatitis C-contaminated blood products to compensate those infected with the virus years ago. The manufacturers of the contaminated products are expected to jointly administer a compensation fund with the government. The law, which was enacted by the Japanese Parliament on December 28, 2007, was followed by a statement from Yasuo Fukuda, Japanese Prime Minister.
“We must frankly admit the state’s responsibility for causing huge harm to the victims and for failing to prevent the harm from spreading,” said Fukuda. “I express my apologies from my heart.”
Momentum had been building in favor of the law as a group of approximately 200 HCV patients had brought multiple successful suits to several district courts during the past five years. The plaintiffs claim that the government’s failure to properly regulate blood products from the 1970s to early 1990s demonstrated clear negligence, resulting in as many as 10,000 HCV infections. Some Japanese media outlets report an even higher number--upwards of two million people infected. According to the Health Ministry, approximately 1,000 individuals are eligible to file a claim. They will receive $109,450-$365,000, depending on how severely they were affected.
“Our five-year battle was finally rewarded,” said Michiko Yamaguchi, leader of the plaintiffs nationwide. The case for government culpability was made stronger in light of events abroad. In 1977, a plasma-derived fibrinogen concentrate lost U.S. Food and Drug Administration approval after it became clear that the product could transmit HCV. Nonetheless, the Japanese government continued to approve the product long after the U.S. ban. Fibrinogen and other plasma products were commonly used in the 1970s by Japanese obstetricians, gynecologists and surgeons to treat hemophilia or simply stop hemorrhaging during childbirth or surgeries.
Several pharmaceutical companies also share a significant responsibility for failure to use viral-inactivation technologies that had become available by the late 1970s. Although these technologies, which included heat and solvent-detergent treatment, effectively eliminated HCV from plasma-derived products, pharmaceutical companies were reluctant to implement them, citing cost and efficacy concerns. Nihon Pharmaceutical Co. and Mitsubishi Tanabe Pharma (formerly Mitsubishi Pharma Corp.), along with Mitsubishi’s subsidiary, Benesis Corp., are all expected to contribute to Japan’s HCV compensation fund.
Sources: ABC news (online), December 28, 2007; BBC news (online), January 8, 2008; and International Herald Tribune, January 11, 2008