Politically connected cancer mogul faces questions over his genetic tests

 In Politics

Patrick Soon-Shiong, the medical entrepreneur who has expanded his influence in Washington by cultivating close ties to both parties, has struggled to meet analysts’ expectations for sales of his GPS genetic test, the key to his plan to transform cancer treatment by matching patients with tailored drug treatments.

At the same time, sales of the GPS test are being boosted by purchases from hospitals and clinics associated with doctors who have financial ties to his network of for-profit and non-profit companies.

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Of 1,286 tests of the GPS test sold in 2016, well over a hundred were by institutions linked to three doctors who have been on the payroll of one of the arms in Soon-Shiong’s network, according to a POLITICO review of financial documents and corporate filings.

In calls with investors, Soon-Shiong has cited the purchases from one doctor’s clinic as proof of the test’s appeal, without mentioning that the same physician was a paid consultant for his company, billing Soon-Shiong’s firm on a month-to-month basis depending on how much work he did on behalf of GPS Cancer.

In a November 2016 earnings call, Soon-Shiong spoke about a “physician in Sarasota Florida who has now shared with me personally how this has affected how he treats patients. . .” He said the doctor, Steve Mamus, had achieved an excellent result with one lung cancer patient, demonstrating that GPS Cancer “is not just a flurry of useless information.”

Soon-Shiong didn’t note that Mamus had begun his paid consultancy two months earlier.

Soon-Shiong’s spokeswoman, Jen Hodson, said the use of doctors as consultants by Soon-Shiong’s companies didn’t present any medical ethical problems, and that “In the cases where physicians have relationships with [Soon-Shiong’s biotech firm] NantKwest there is a proactive conflict of interest policy which is available on our website for all to transparently see.”

The policy “requires comprehensive disclosure of the [doctors’] financial interests” to patients involved in medical research, but imposes no restrictions on other activities, such as earnings calls with investors.

Nonetheless, Marc Scheineson, a lawyer at the firm of Alston and Bird with a specialty in food and drug matters, said disclosure of such ties to investors is crucial to enabling them to assess the independence of the doctor’s recommendation. In promoting a product, “you’ve got to disclose any material connections you wouldn’t expect,” said Scheineson.

Hodson didn’t specifically respond to questions regarding Soon-Shiong’s comments on earnings calls.

Even as some of Soon-Shiong’s products have been slow to catch on, his vows to revolutionize the treatment of cancer have captured the attention of national leaders eager for a fresh approach to one of the medical world’s greatest challenges. Soon-Shiong has had repeated meetings with former Vice President Joe Biden, while serving on a blue ribbon panel associated with Biden’s Cancer Moonshot policy.

Soon-Shiong has also appeared on multiple conference panels — and shared an onstage joke or two — with former President Bill Clinton, and met at least twice during the presidential transition period with Donald Trump, who considered him for a job. House Speaker Paul Ryan recently appointed Soon-Shiong to an HHS advisory committee. In May, when Soon-Shiong’s appointment was announced, Ryan’s spokeswoman said that the doctor had “an accomplished history in medical innovation” and would be a “sound and trustworthy voice.”

Soon-Shiong’s presence as a policy adviser is significant because of his frequent criticism of traditional approaches to cancer research and medicine. In a January 2016 interview with the science publication Nautilus, he declared, “We’ve been losing the war [on cancer]. As physicians, we’re trained to be reductionist. We rigidly follow protocol. But life is not that way.”

Born in South Africa to ethnic Chinese parents, Soon-Shiong made billions of dollars in the United States by creating and selling a pair of drug companies. Lately, he has been raising his profile in other ways. He also owns a large stake in the newspaper chain Tronc, which includes the Chicago Tribune and Los Angeles Times.

At various points in his long career, the 65-year-old Soon-Shiong has been dogged by ethical complaints. In 1993, he attempted a bold strategy to combat diabetes: transplantation of pancreatic islet cells into one patient. The patient seemed cured at first, even eating ice cream at home. Then the effects wore off, and the patient later committed suicide. The American Diabetes Association’s president sought to tamp down the hoopla, saying “We don’t need this kind of inappropriate hype.”

Conflict of interest concerns also recur throughout Soon-Shiong’s career. Just this month, a report from the Utah state legislature’s Office of the Legislative Auditor General found that, following a series of donations from Soon-Shiong to the University of Utah, the school improperly bypassed procurement rules to give Soon-Shiong’s for-profit firms a contract without competition.

Earlier, a 2002 investigation by The New York Times found a shareholder in one of Soon-Shiong’s drug companies helped sell the drug company’s product to its own hospital clients, apparently without disclosing the relationship. A POLITICO investigation earlier this year revealed a pattern of the recipients of Soon-Shiong’s charitable gifts later purchasing his company’s products.

In April, when pressed by POLITICO regarding conflict-of-interest questions related to his non-profits, Soon-Shiong stated that, “All of these endeavors, including my charitable endeavors, are primarily done so with the hope that my efforts and my funds will work to reduce and even prevent the deadly consequences of multiple forms of cancer, as well as other debilitating and deadly conditions or diseases.”

Undisclosed consultancy

GPS Cancer is a new Soon-Shiong product, officially rolled out in summer 2016. It’s intended to serve as a means to map the genetic or protein characteristics of a person’s tumor in order to match it with a particular drug treatment or clinical trial. It has been submitted to the FDA for approval, but is one of many competing tests on the market.

Financial analysts are closely watching its sales. Last November, the investment banking firm of Cowen & Company estimated that Soon-Shiong’s company would sell 2,000 tests, which go for approximately $10,000 each, as a “downside” scenario for 2016. It sold 1,286, according to a press release announcing year-end results for NantHealth, Soon-Shiong’s software firm.

More than a hundred of those sales came from Florida, where GPS Cancer has been championed by Mamus, a 63-year-old hematologist who co-founded the Cancer Center of Sarasota. In an interview, Mamus estimated that he had ordered 200 GPS tests over the past two years. By September 2016, he was also on the payroll of NantHealth as a consultant.

In an interview, Mamus said he first became familiar with GPS Cancer when he saw a 2015 conference presentation on the test. “It was just totally cool,” he said. After a “spectacular result” with one patient with advanced lung cancer whose tumor was assessed with GPS Cancer, he said he became convinced that the test was a “generational leap” forward.

As a consultant, Mamus said, he helps with two large research projects related to the test and communicates with the Centers for Medicare and Medicaid Services about the test’s effectiveness.

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