Xenotransplantation Advisory Committee Recommends Taxpayer Subsidies for Risky Technology While Downplaying Disease Prevention

Countless Problems Have Driven Investors Away

(Washington, DC) – Members of a federal advisory committee expressed concern Tuesday about the drop-off in private sector funding for cross-species transplantation, or xenotransplantation – a reflection, perhaps, of waning confidence in unfulfilled promises of mass-produced pig organs and profits to match; or fears of money wasted on a field plagued by technical problems, legal and regulatory challenges, and bad publicity over animal welfare concerns.

Throughout the course of the fifth meeting of the Secretary's Advisory Committee on Xenotransplantation (SACX), Committee members repeatedly called for increased federal spending on the technology.

“Too much taxpayer money has already been wasted on xeno and it’s gone into a black hole,” says Alix Fano, Director of the Campaign for Responsible Transplantation, a coalition of 90 public interest groups.

Fano points out that the Commerce Department’s Advanced Science and Technology Program has given multi-million dollar grants to PPL Therapeutics and others for transgenic pig breeding and cloning projects, many of which are now defunct. The FDA has spent untold resources on regulatory and oversight matters. The National Institutes of Health (NIH) has dispensed tens of millions of dollars in grant monies to researchers over several decades with unknown outcomes. The NIH’s Small Business Innovative Research grant program is supporting the development of Immerge/Novartis’s “knockout pigs” which the company is touting as the latest transgenic wonder, despite the fact that one of its pigs was born with only one eye. “When will these public subsidies to unethical private industries stop?,” asks CRT’s Fano.

Xenotransplantation is inherently unethical and inhumane. At the meeting, Christopher McGregor of the Mayo Clinic’s xenotransplantation program described gruesome pig-to-baboon heart transplant experiments, hundreds of which have already been performed in the U.S. and elsewhere. The median survival time for the baboons was allegedly 76 days (or 2.5 months), considered a breakthrough; though McGregor revealed that one baboon died from a toxic overdose of immunosuppressive drugs while others died from untreated cytomegalovirus infection, which is transmissible to humans.

While the measure of “success” in pig-to-primate experiments was defined by the number of days the baboons survived, the quality of the animals’ brief lives was not discussed. But internal documents, leaked from Novartis U.K. in September 2000 revealed that baboons and monkeys transplanted with genetically engineered pig hearts and kidneys suffered terribly. Over a quarter of the primates died as a result of their surgeries, most within hours or days. Diarrhea, vomiting, tremors, hemorrhage, infection, weakness, swelling of the eyes, wounds seeping blood and pus, rapid involuntary eye movements, breathing difficulties, and grinding of teeth were some of the recorded list of agonies these animals endured.

These embarrassing documents did not seem to phase Novartis/Immerge which announced plans to conduct similar experiments by this Spring, even though researchers acknowledge that baboons are poor models for xenotransplantation outcomes in humans. “Animal welfare discussions are virtually absent from these SACX meetings; it’s disgraceful,” says Fano.

Human trials with pig cells and tissue continue to pose regulatory challenges. Extensive discussions about informed consent regulations revealed that patients participating in xeno trials could withdraw from such trials and from programs which monitor them for infectious pig viruses. Food and Drug Administration guidelines call for lifetime monitoring for viruses in these patients but forced compliance is illegal, creating a frightening public health problem. Moreover, current laws do not require informed consent from third parties such as health care workers or intimate contacts. The SACX stressed that xeno patients have the “responsibility to educate contacts” about disease risks, but this is also unenforceable. Equally problematic is the volatility of the biotech sector. What if a xeno company, which is charged with monitoring its patients for life, goes out of business? Who would be responsible for monitoring those patients then?

During a workshop discussing a draft document on the state of xeno science, several members of the SACX complained that their draft placed too much emphasis on prevention. One member commented that the report should “give a nod to prevention” but should state that it wouldn’t solve the organ shortage or “eliminate the need for intervention.” Mayo’s McGregor stated that “alternative technologies” posed a challenge to xenotransplantation. It was suggested that SACX documents describe stem cell technology - widely viewed as a replacement for xenotransplantation - as being “in its embryonic stages.”

“The heavy industry influence and lack of public involvement or debate at these meetings, makes it quite obvious that the SACX was not set up for the public’s benefit,” says Fano.