Dr. Graham Sher has to be the most confident guy on the planet.
While experts around the world are cautious about making safety claims regarding blood-based products, the CEO of Canadian Blood Services told a hand-selected Health Canada round table forum in April that the present manufacturing processes now include “steps to inactivate any virus or other contaminants, known or unknown.”
He further claims that there has been no transmission of infectious disease through plasma products in Canada in 25 years – at least that he was aware of.
This is a leap from the caution expressed by Justice Horace Krever in his final report of the Royal Commission into Canada’s blood system (1993-97).
At the time Krever suggested that tracking infection associated with the use of so-called “plasma derivatives” was difficult.
“It is possible, however, that cases of infection have occurred but have not been recognized or reported,” the Justice reported.
Krever referred to a 1996 editorial in the journal Gastroenterology: “Any given product is usually widely distributed throughout the United States and abroad. In any given locality, there may be only individual or a few cases from this potential source. To be documented, it has been necessary to have a common exposure to pooled plasma products of two or more patients in an individual practice, clinic, or category of patients. For a complete investigation, the manufacturer and lot number(s) must be recorded, which is seldom done. Although a shelf life of two years means that infections can be widely scattered in time, it is usually necessary for the dates of onset of derivative-transmitted viral hepatitis to be in relative proximity to each other to provoke an investigation. Finally, infections by pooled plasma derivatives are often subclinical and escape detection unless corecipients of the particular material are also screened by aminotransferase and/or serology.”
A much more recent paper by Lucy Reynolds, a research fellow at the London School of Hygiene and Tropical Medicine, notes plasma products in the UK “have a track record of avoidable quality problems.”
Writing in an April 2013 paper for Open Democracy, Reynolds notes there is no reliable test for variant Creutzfeld-Jacob disease. Parvovirus B19 has recently made the jump to humans, yet it is resistant to heat, detergent or solvent treatments.
British Lord David Owen, MD, recently wrote to Prime Minister David Cameron expressing concern about the privatization of Plasma Resources UK. Owen stated “I cannot stress enough that we simply do not know everything about the mutation of genes and the spread as of yet unidentified infections to be anywhere near certain of relying exclusively on purchasing plasma supplies on world markets.”
Nor did a Canadian expert panel express Sher’s confidence in one of the most sought-after plasma derivatives – intravenous immune globulin (IVIG) – in 2007.
Just five years ago in a paper intended to establish guidelines for its use, Tom Feasby, Brenda Banwell and others stated “IVIG is a product made from large pools of human plasma and it is not possible to claim with certainty that there is no risk of infectious disease transmission.”
Testing may also overlook more recent developments among donors. The UK’s Reynolds again notes that antibody-based tests may pass a patient with primary infection from a very recent risk as negative.
It’s not like there haven’t been problems with IVIG in the past.
One of the reasons for international shortages at the end of the 1990s was the US FDA’s intervention in the industry, concerned that “the plasma industry lags behind the drug industry in compliance with GMP (good manufacturing processes).”
Given these products are not made in Canada, Sher should really be looking internationally for evidence, not just within our own borders.
He might have found, for example, some significant problems with Chinese IVIG in 2006 despite passing routine local inspections. Then there was the investigation into the sale of “fake albumin.”
Following the deaths in this province as a result of SARS, health care providers adopted the precautionary principle to keep both healthcare staff and patients safe.
We cannot understand why Sher is so eager to support a rival’s application to operate a major private for-profit plasma collection operation that will break with Canada’s more cautious approach towards unpaid or “altruistic” donations.
Aside from the for-profit plasma industry, he is outside the mainstream when he says there is no difference in safety between paid and unpaid donors.
If you want to sign a petition calling on the Federal Minister of Health to ban paid donation, please click here.
If you want to send more in-depth comments to Health Canada (by July 26) please see our story last week.