Friday, January 27, 2017

Will Trump's Leadership Picks Smack Down Health Care? - A Drug Company Lobbyist, an Entrepreneur Who Wants to Weaken Drug Testing, and a Mysterious Billionaire Who Settled Fraud Charges

President Trump in his inauguration speech promised to reach out to "struggling families" and to benefit "American workers and American families," and promised all Americans "you will never be ignored again."  Yet the Trump transition team, and now presidential administration continues to consider individuals for health care policy leadership roles remarkable for their conflicts of interest, which often did not merely arise from small financial transactions but from their roles as corporate insiders, and in some cases, association with dubiously ethical practices.  They are particularly remarkable for their lack of interest in, if not ignorance of American workers' and families' health, except perhaps as a vehicle for personal profit. 

Discussed in order of increasing potential power.

Jack Kalavritinos for FDA "Beachhead Team"

As reported by StatNews (unfortunately behind a paywall) on January 19,

Former pharmaceutical lobbyist Jack Kalavritinos, who also worked in various capacities for the George W. Bush administration, will take a major role on the 'beachhead' team that the incoming Trump administration is sending to run the Food and Drug Administration following Friday’s inauguration, transition team sources say.

Kalavritinos spent seven years as director of global lobbying for the Irish pharmaceutical and medical device company Covidien, which sells a wide array of hospital supplies around the world.  The US company Medtronic bought Covidien in 2014 and promptly moved its headquarters to Ireland, which had a lower corporate tax rate.

Mr Kalavritinos worked in Department of Health and Human Services as the Director of the Office of Intergovernmental Affairs as until 2007 before moving to Covidien in 2008 (look here), and stayed until 2015 (look here).

Thus he is a frequent traveler through the revolving door, going from the Department of Health and Human Services to Covidien, and now back to the DHHS.  Some experts consider the revolving door to be a form of health care corruption (look here).

Further note that he secured this new position despite the fact that he worked in a leadership position at Covidien during its "tax inversion":

Such 'inversions' - deals structured to let American companies take advantage of lower tax rates overseas - began to draw heavy public ire around the time of the Medtronic-Covidien deal.  The Obama administration has sought to crack down on such transactions with new rules from the Treasury Department.

President ... Donald Trump seemed to be referring to such deals, as well as the outsourcing of manufacturing, when he recently accused the pharmaceutical industry of 'getting away with murder.'
Finally, note that Medtronic has quite a history of misbehavior, as documented here, including settling multiple cases alleging its use of kickback, and hiding device safety information. 

Thus, Mr Kalavritinos has been a corporate insider for years, and an insider of a corporation which used financial maneuvers and apparently unethical actions for financial benefit.  In his track record are no indications he has any particular interest in improving the health of American workers and American families. 

Dr Joseph Gulfo for Commissioner of the Food and Drug Administration

Dr Gulfo appears to be the latest person to be vetted by the Trump administration to be FDA Commissioner.  As reported by the Boston Business Journal on January 24,

In an interview today, Dr. Joseph Gulfo — an author and former CEO of drug and medical device companies — confirmed that he has spoken with two members of President Donald Trump’s transition team about being the named commissioner of the Food and Drug Administration.

While Dr Gulfo is a physician, it seems he has not practiced in years.  Instead, he has mainly been an entrepreneur and executive.  As noted in his online biography,

Dr. Gulfo has more than 25 years of experience in the biopharmaceutical and medical device industries. As President & COO of Anthra Pharmaceuticals and Chairman of its UK subsidiary, he was responsible for the 1998 NDA approval of Valstar, a drug for superficial bladder cancer, which had sales of $27 MM in 2012, 14 years after its approval. Dr. Gulfo was also instrumental in the development of ProstaScint (Cytogen Corporation), a BLA-approved monoclonal antibody for prostate cancer. He was CEO and Chairman of Antigen Express, an immunotherapy and immunodiagnostics company in the field of vaccines for cancer therapy, antiviral therapy, and asthma, and led its merger. In 2012, he received the American Business Awards’ Maverick of the Year Award....
Note that his personal biography emphasizes the sales of the drugs his companies sold, not their benefits to patients.

More recently,

he served as President & CEO of MELA Sciences (2004-2013), and was Chairman of the Board (2011-2013).


 He is Executive Director of the Lewis Center for Healthcare Innovation and Technology at Fairleigh Dickinson University (FDU) [within the School of Pharmacy and Health Sciences].
His personal biography did not explain how any of his products or corporate accomplishments improve health of American workers of families.

So were he appointed, Dr Gulfo might be considered as transiting the revolving door, with implications as above.  Again, Dr Gulfo did not merely have financial relationships with health care corporations, but was top executive of several corporations, and thus was obviously a corporate insider.

Furthermore, as former top executive of multiple pharmaceutical and biotechnology companies, Dr Gulfo seems interested in making FDA standards for drug approval more lenient.  In particular, he has argued for approving drugs based only on their ability to make patients' "biomarkers," that is laboratory test results that may be correlated with clinical outcomes or patient-centered outcomes, but not absolutely.  So he would allow drugs that have never been shown to improve symptoms or functional status, or to reduce disease morbidity, complications, or early death. And it is likely that many drugs approved in this manner would never be proven to have any such benefits.  But all drugs have side effects, so this policy would expose patients to risks, without the chance of obtaining any benefits.  This is not what one should really call patient-centric.

Nothing in his track record suggests any great interest in the health of American workers and American families, except as consumers of his products.

Dr Patrick Soon-Shiong for "Health Care Czar"

As StatNews reported on January 24

Dr. Patrick Soon-Shiong, an audacious biotech billionaire who has pledged to 'solve health care,' has been in talks with the Trump administration about the possibility of serving in a senior role overseeing the US health care system, according to individuals familiar with the discussions.

Soon-Shiong, a trained surgeon, has met with President Trump and his advisers at least twice in recent weeks. During those discussions, he raised the possibility that he could serve as a 'health care czar' with a broad portfolio in the administration as it seeks to reshape the health care system and replace the Affordable Care Act, according to two individuals, who spoke on the condition of anonymity.

Far from solving health care, Dr Soon-Shiong seems known for making inflated claims that are never borne out.

In the early 1990s, Soon-Shiong claimed that he may have cured diabetes in a patient named Steven Craig by implanting cells that secrete insulin. The treatment worked, for a while — launching an outpouring of media attention for Soon-Shiong’s diabetes company, VivoRx. But he faced criticism in ensuing years, as the results were not reproducible.

'It’s far too early to view this as a cure, or even a therapy,' Dr. James Gavin, then-president of the American Diabetes Association, once said of Soon-Shiong’s therapy. 'We don’t need this kind of inappropriate hype.'

So this may be why

he now has a reputation for talking more than doing. 'Every time I hear his name uttered by an academic oncologist, it’s with an eye roll,' Dr. Vinay Prasad, an oncologist at Oregon Health and Science University, told STAT late last year. 'If you asked a dozen oncologists what they think of him, his general reputation is that of a shameless self-promoter.'

In fact, his claims have gone from inflated to allegedly fraudulent,

Generic drugmaker Mylan had invested in VivoRx to support its diabetes work, but much of the money was actually used to support a separate company Soon-Shiong set up — VivoRx Pharmaceuticals, which researched cancer drugs instead. That resulted in a fraud lawsuit from Mylan and Terrence Soon-Shiong, Patrick’s business partner.

Patrick Soon-Shiong paid $32 million to settle the lawsuit.

Furthermore, while he apparently became a billionaire, there is some controversy about how he did so. As another StatNews article reported on January 25,

The core of Soon-Shiong’s enterprise is called NantWorks, from which at least 10 interconnected biotech companies have grown. Each has raised hundreds of millions of dollars, and each tends to make deals with other firms under Soon-Shiong’s umbrella.

But not one has successfully developed a drug, and investor enthusiasm has waned.

Nonetheless, apparently Dr Soon-Shiong has paid himself handsomely, presumably in part of using other peopeles' money:

But Soon-Shiong personally has done well. In 2015, NantKwest paid him more than $148 million in stock and options, and he still owns a roughly 50 percent share of the company. He also owns about 57 percent of NantHealth, according to a regulatory filing, a stake worth more than $500 million.

All told, Bloomberg estimates he’s worth $8.8 billion.

The one drug with which he is most identified was apparently just an old drug repackaged, but sold for a then extremely handsome price:

It seems a little quaint now: More than 10 years ago, Soon-Shiong’s signature cancer drug, Abraxane, came under fire for being too costly. The medical community was outraged at Abraxane’s $4,200 price tag, describing the drug as 'old wine in a new bottle' because it’s an updated version of the long-used chemotherapy drug paclitaxel. Of course, considering the pricing of cancer drugs today, that’s practically a bargain.

Thanks to the commercial success of Abraxane, Celgene bought Soon-Shiong’s company, Abraxis, for a stunning $2.9 billion. That’s where he got most of his wealth.
Note that Abraxane is simply paclitaxel "protein bound." While it was not very innovative, Dr Soon-Shiong made it very pricey, leading to his own financial benefit, but not clearly to big benefits for patients. 

So Dr Soon-Shiong is the ultimate corporate insider, a multi-billionaire corporate CEO, an "entrepreneur" who has mainly benefited from financial manipulation, a great "innovator" who has never developed an innovative product that actually has been shown to improve human health.  Again, there is nothing in his track record demonstrating concern for the health of American workers and American families. 


These latest examples show that the Trump transition team and now the Trump administration seem to have affinity for health care advisers and leaders with numerous and severe conflicts of interest, whose expertise may be more in marketing and public relations that biomedical science, medicine, public health, or health policy, and who are known to make outrageous claims, even to the point of carrying whiffs of fraud.  They are all rich corporate insiders.  The administration's latest flirtations include a former lobbyist for a biotechnology firm, and two non-practicing physician-entrepreneurs.  The former worked for a company with a long history of ethical lapses.  One of the latter has promised many breakthroughs, none of which has so far apparently panned out, and settled allegations of fraud.  Nothing made public about any of them at this point suggests that they have deep underlying concerns for patients' and the public's health. 

While their flamboyant histories may appeal to someone like Mr Trump, with his own history of outrageous marketing stunts, and of marketing dubious health schemes (look here), their potential to put the health needs of patients and the public first is not obvious.  None of the three people discussed above are credible candidates to lead any part of any US government agency involved in health, health care, or public health, in my opinion.  None of these three people displayed any great concern for patients' or the public's health, despite Mr Trump's fervent claims that he will not ignore American workers and American families.

To repeat, true health care reform requires well-informed leaders who uphold health care professionals' values, put patient's and the public's health ahead of all other considerations, avoid self-interest and conflicts of interest, are honest and ethical, and surely are not corrupt.  They need to work in the context of a government that is of, by and for the people, not of, by and for a demagogic leader.

US health care may be heading for not better health for American workers and families, but for a Trump administered smackdown, like the one he delivered on a professional wrestling show:

Maybe it would have been better had Mr Trump ignored us American workers and families.

1 comment:

Anonymous said...

Personally, it is my belief that the “Medical Congressional Complex” – now clearly encompassing both Parties – doesn’t give an Expletive Deleted about Coasties vs Flyover, Democrat/Replublican/Left/Right/Center. The MCC has created a set of monopolies that will simply strangle the US economy, sooner rather than later.

A White House Petition for the prosecution of these monopolies under 15 USC Chapter 1 has been created. I have signed on and request that you pop over, take a look at it, and decide if you want to do the same:

Thank you for your time and attention.