21 July 2019

Regenerative Medicine and Cryonics Litigation

The Leading Innovation: The UK’s ATMP Landscape report from the Alliance for Regenerative Medicine (ARM) and UK BioIndustry Association comments
The UK is a cornerstone in the international life sciences community, and advanced therapy medicinal products (ATMPs) are a fast growing part of the UK economy. The UK cell and gene therapy industry employs 1,500 people; by 2035, the cell and gene therapy industry could be worth £10B and provide 18,000 jobs. 
This report is intended to provide an overview of the current ATMP sector landscape in the UK. The growth in this industry highlights the need for coordinated efforts to promote regulatory pathways for safe and effective products, develop and implement innovative reimbursement options, address challenges in scale-up and manufacturing, and foster international policy convergence to ensure that patients across the globe are able to access these products in a timely manner
Key takeaways are
1 The UK is a leading source of innovation in the research and development of advanced therapy medicinal products (ATMPs) in Europe. 
2 There is strong government support for scientific innovation, capital formation, and patient access to cell and gene therapies in the UK. 
3 There is significant investment in the UK to support the development of these life-changing therapies. 
4 The clinical pipeline in the UK, both in terms of UK-based companies and other companies interested in clinical development in the UK, is robust and growing. 
These therapies are already positively impacting thousands of patients worldwide. In order to ensure that patients in the UK and globally can continue to access these transformative therapies, it is imperative that stakeholders from across the sector continue to promote a positive environment to support the research, development, approval, and commercialisation of ATMPs. ... 
The realisation of the immense therapeutic potential will require stakeholders to: 
1 Support scientific research to develop and advance both cell and gene therapies
and ancillary processes, including manufacturing and scale up. 
2 Foster economic development and the creation of a skilled workforce to promote the continued growth of this industry in the UK. 
3 Cultivate a positive regulatory environment for the research and development of cell and gene therapies, including fostering accelerated pathways to ensure that patients are able to access safe and effective therapies in a timely manner. 
4 Develop the necessary infrastructures within NICE and its counterparts in Scotland, Wales, and Northern Ireland to ensure health technology assessments are able to address the long-term value provided by cell and gene therapies. 
5 Collaborate with the NHS and other public and private payers in the UK to develop innovative financing models to ensure patients can access approved therapies in an efficient manner.
Meanwhile, as an illustration of litigation in the cryonics sector (more faith than science), Kurt Pilgeram in Montana is reportedly seeking $1m from the Alcor Life Extension Foundation for allegedly improperly removing his father's head, cremating the body and sending the ashes to Pilgeram's family members. The son also alleges that Alcor refused to return his father's head - currently in a vat of liquid nitrogen - so that he can cremate it.

One media item features the “They chopped his head off, burned his body, put it in a box and sent it to my house” subhead. Pilgeram Sr, a biochemist, was an enthusiast for cryonics. He is reported to have signed an agreement for whole-body preservation, in contrast to neurocryopreservation (where just a severed head is in cold storage pending purported eventual 'reanimation'). Alcor apparently indicated that it could not guarantee that it would be practical to fulfil all parts of the agreement; ultimately the head was removed and shipped off to the Alcor repository in Arizona when Pigeram died unexpectedly in 2015.

Alcor initially sued Kurt Pilgeram in 2017 after he allegedly attempted to stop his father’s life insurer from paying Alcor, which often depends on such payments. The insurance company had previously asked the courts to force litigation between the parties to settle the dispute. Alcor charges U$200,000 to preserve an entire body (supposedly in perpetuity), with its fee for neurocryopreservation being US$80,000.

The item states that Jim Pilgeram, a brother of the litigant, said “He believed in cryonics, but he didn’t believe in mutilation. He made it awful plain to them people that he did not want to be just a head".

Pilgeram reportedly alleges that Alcor promised that his father's body would be preserved and that the company "arbitrarily, fraudulently, and in bad faith" severed the elder Pilgeram's head and then cremated the body rather than deliver the remains to the family whole. Further, "inconclusive" tests have suggested the cremated remains may not be entirely his father's.

Pilgeram alleges elder abuse, infliction of emotional distress, breach of contract, unfair business practices, and intentional misrepresentation on the part of Alcor. Alcor argues that it was possible to reach Alcor during the weekend at the time of Pilgeram’s death but it wasn't alerted to Pilgeram’s death quickly enough to preserve the whole body. Court filings reportedly argue that "the fault of Pilgeram or others besides Alcor" caused the alleged damages, with Pilgeram failing "to use reasonable diligence" to mitigate the alleged damages