Politically connected cancer mogul faces questions over his genetic tests

 In Politics

Mamus also said he has touted the test to Biden and Clinton. He has discussed the test in news stories and on the company’s promotional videos. But NantHealth doesn’t always disclose that he’s a paid consultant, whether in social media posts or other official communications.

For example, NantHealth cited Mamus as an authority in a December 2016 press release and accompanying video, without noting the financial relationship. The press release says Mamus “offered [the test] to more than 100 patients,” while another NantHealth press release says 138 GPS Cancer orders came from Florida during 2016.

Soon-Shiong himself has used Mamus’s experience and endorsement as an example of the power of GPS Cancer.

After touting Mamus’s endorsement in his earnings call last November, Soon-Shiong again referenced Mamus on an earnings call in May of this year, assuring investors that once doctors learned more about the GPS test they would order more of them; he pointed to Mamus and doctors at the University of Indiana as indicators of the test’s growing popularity: “I think the University of Indiana is now up to 200 consecutive tests and similarly at Sarasota maybe over 100 tests. So I think that is what is encouraging is that once the education occurs, the utilization and adoption will take place.” He did not mention that Mamus was on his payroll.

Scheineson, the food and drug lawyer from the firm of Alston and Bird, said videos featuring Mamus should note his paid consultancy, to make clear that he may not be an entirely disinterested advocate for the test. The promotional material contains no such disclosure.

Other paid doctors

Two other doctors, Leonard Sender and John Lee, have held senior positions at institutions making GPS Cancer orders while simultaneously serving in paid positions at NantKwest, Soon-Shiong’s biotech company.

Both doctors’ home institutions, Children’s Hospital of Orange County and Sanford Health, have ordered GPS Cancer tests; in addition, an El Segundo, California, cancer clinic founded by both doctors will be ordering the tests for clinical trials, NantWorks’ spokeswoman said, with the costs being covered by NantKwest.

Sender, a pediatric oncologist, “was involved in the ordering” of 87 GPS Cancer reports used in a research study, a spokeswoman for Children’s Hospital of Orange County said. The tests were ordered between August, 2016, and March of this year.

During much of that period, Sender was also working for Soon-Shiong’s network. Hodson said Sender had joined NantKwest in 2016, without specifying the precise date. An October 2016 press release describes Sender as the director of the “Cancer [Breakthroughs] 2020 Pediatric, Adolescent and Young Adult Cancer” initiative, which in turn is described, in Sender’s NantKwest biography, as part of the Chan Soon-Shiong Family Foundation, a Soon-Shiong-affiliated charity named for his wife.

Sender did not respond to multiple requests for comment.

A third doctor, John Lee, is described on the NantKwest website as its senior vice president of adult medical affairs.

After joining NantKwest in May of 2016, according to his LinkedIn profile, Lee began a consultancy midsummer with Sanford Health of South Dakota. The hospital ordered six GPS Cancer tests, Hodson confirmed, though she didn’t specify when; a Sanford Health spokeswoman says 10 tests were ordered between fall 2016 and October 2017.

According to Hodson, Lee’s consultancy ended in August of this year; Sanford Health says Lee’s consultancy ended in September. Lee declined requests for interview, and a Sanford spokeswoman would not comment on whether Lee had ordered the tests.

Meanwhile, Lee and Sender are co-founders of the Chan Soon-Shiong Institute for Medicine, the cancer clinic in El Segundo that is slated to become another institution driving GPS Cancer tests, according to its press releases.

The clinic, announced in July, has the goal of putting “close to 100 percent” of its patients in clinical trials, Sender told the local paper, The Daily Breeze. The clinic intends to immediately enroll pancreatic cancer patients in the “Nant Pancreatic Cancer vaccine trial,” Lee said in a July news release.

That vaccine trial will involve the ordering of 80 GPS Cancer tests, whose cost will be covered by NantKwest, Hodson said, noting that the clinic has a conflict of inflict policy. Among other tenets of the policy, it requires disclosure to patients participating in clinical trials of the investigators’ financial interest.

Despite the push from the doctors associated with various arms of Soon-Shiong’s network, GPS Cancer has failed to meet Wall Street expectations. In NantHealth’s first quarter 2017 earnings call, Soon-Shiong attributed the company’s slow sales to the lack of understanding of clinicians, most of whom “have very little knowledge of the word transcriptome or RNA protein expression or even genome.”

Clinicians do indeed feel uncertain about the value of genomic testing. In a survey of 132 oncologists released in May by medical publication Medscape, nearly three-quarters said the clinical utility of genomic testing was “unclear and too cost-ineffective at present to support widespread use.”

Meanwhile, GPS Cancer doesn’t appear to be the leading brand in the field. One of the competitors cited by NantHealth’s SEC disclosures – Foundation Medicine – sold 43,686 tests in 2016, according to its annual report filed with the SEC. Foundation’s flagship test examines a fraction of the genome – 315 genes at present – which that company characterizes as validated by the scientific literature. NantHealth, in its 2016 annual report, claims its product is the most comprehensive in the marketplace, as it surveys the entire genome – approximately 20,000 genes. Its combination of genomic and proteomic results drastically reduces the rate of false positive tests, according to NantWorks’s spokeswoman.

Yet insurers and government are cautious about reimbursing any form of genomic testing in most instances. A Blue Cross Blue Shield coverage review from August declares proteogenomic testing – a category which includes GPS Cancer – as “investigational for all indications.”

“There is no published evidence on the validity or utility of the GPS Cancer test,” the insurers’ review continues. “For proteogenomic testing in general, the research is at an early stage.”

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