e-mail campaign to nz health minister

Afternoon all,

It appears as if some parties are starting up another e-mail campaign to the new NZ Health Minister (Tony Ryall)urging him to approve LCT's trials. Below is an example of one of the letters sent. If you want to voice your opinion then e-mails should be sent to the following people (perhaps best not to say you're a shareholder and want the trials to go ahead so the SP explodes):

"Ryall, Hon. Tony" [[email protected]]
"Key, Prime Minister John" [[email protected]],
"Wood, Peter" [[email protected]],
"Elliott, Professor Robert B." [[email protected]],
"Shadbolt, Tim" [[email protected]],
"English, Bill" [[email protected]],
"Mapp, Wayne" [[email protected]],
"Jessamine, Dr. Stewart" [[email protected]]

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Dear Minister Ryall,

I am writing as a follow-up to my last message to you on March 19, 2009 regarding the small clinical trial by Living Cell Technologies (LCT) that was approved by your safety and ethics committees and by the cabinet of the last government in 2008, but which has been placed on hold by your government. I will not repeat the various arguments in defence of this trial (please see my earlier email below), but I would like to look at the issues involved from the perspective of conflicted interests and public safety.

Most of the opposition to this clinical trial is coming from an organization known as the International Xenotransplantation Association (IXA). On its own website, IXA lists as its corporate sponsors Astellas, Bristol-Meyers Squibb, Genzyme, Novartis, Roche and Wyeth. These corporations are the world's major suppliers of anti-rejection drugs that must be taken for life by any recipient of a transplanted organ or tissue. According to the U.S. Department of Health and Human Services, these drugs can cost a transplant recipient over $10,000 per year for life.

IXA's corporate sponsors have a vested financial interest in xenotransplantation because of its potential to dramatically increase the number of transplant recipients through the use of pig organs that are available in almost unlimited quantities. The massive increase in transplant recipients translates into a massive increase in revenue from sales of their anti-rejection drugs. It goes without say that this lifelong annuity from an existing and expanded base of transplant recipients is very important to IXA's corporate sponsors, and it can be expected that they will lobby vigorously against any threat to their revenue stream.

LCT's clinical trial is the first time that organ tissue will be transplanted to cure disease without the use of anti-rejection drugs. The medical risks associated with immune suppression, including cancer and infection, as well as the lifelong costs are eliminated by LCT through immuno-protection of the transplanted cells, not immuno-suppression of the patient's entire immune system. Thus, the patient is freed from both the risks and costs of lifelong immune suppression. IXA's conflict of interest arises because LCT's immuno-protection technology is a significant threat to the profitability of its sponsoring drug companies.

It is instructive to note that the research program of Dr. Bernhard Hering, described by IXA in 2007 as "Councilor - International Xenotransplantation Association", is focused on xenotransplantation of pig islets for the treatment of diabetes. The difference between Dr. Hering's protocol and that of LCT is that Dr. Hering proposes using conventional lifelong immuno-suppression to prevent tissue rejection, while LCT uses immuno-protection. It would therefore appear that IXA and their corporate sponsors are less concerned about the risks of xenotransplantation than they are about the threat of an alternative to lifelong immuno-suppression and the resultant revenue losses.

Megan Sykes, past president of IXA, has cited the work of Dr. Clive Patience as evidence that PERV may be able to infect human and other primate cells. Yet in the journal Xenotransplantation in 2009, Dr. Patience concluded that PERV infection did not occur even in heavily immunosuppressed primates. The paper concluded: "These results indicate that in a primate model, in the presence of chronic immunosuppression, neither the inoculation of cell-free nor cell-associated PERV using a virus already adapted to primate cells results in an infection". Similarly, a 1998 paper published in Transplant International likewise concluded that "transplantation of these [PERV-expressing] cells into baboon recipients did not result in virus transmission, not even under heavy immunosuppression." If PERV infection proved impossible in primates under heavy immunosuppression, then infection of a human being with a functioning immune system is virtually impossible, and transmission to others is a non-existent risk.

IXA has failed to provide compelling scientific backing for its vague warnings about LCT's clinical trial, while IXA's sponsors have a clear interest in the failure of these trials. It would be a tragedy if families with diabetes are forced to unnecessarily suffer the horrors of this disease to serve the interests of IXA's corporate sponsors.

In summary, PERV infection of humans or other primates has never happened despite millions of opportunities over centuries of pig-human interactions, including thousands of living pig cell injections in various treatment modalities over the past century, dozens of experimental islet xenotransplants, studies deliberately inoculating immune-suppressed primates with high titers of PERV, and thousands of daily injections of virus-positive pig insulin by diabetics immediately following Banting & Best's discovery.

Of primary importance in this discussion is the fact that pigs from the source herd used by LCT all test negative for PERV retroviral particles. In other words, the pigs do not even express the virus, and hence cannot pass it to any tissue recipient. That factor alone assures the safety of this clinical trial.

If ethics and science are to prevail, LCT's clinical trial must not be further delayed.

I trust we can look forward to a decision by your government in accordance with scientific evidence, ethical consistency, and your own safety and ethics committees, and that New Zealand can take its rightful place as a biotech leader in the new millennium.

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Have a good day.


Cheers

SW