Thursday, August 24, 2017

A Stealth Marketer Goes Through the Revolving Door to ... the President's Council of Economic Advisors?!

Stealthy, deceptive systematic marketing, lobbying, and policy advocacy campaigns on behalf of big health care organizations, often pharmaceutical, biotechnology and medical device companies, have long been a subject of Health Care Renewal.  A relatively recently revealed example was the stealth marketing campaign used by GlaxoSmithKline to sell its antidepressant Paxil.  This campaign included manipulating and suppressing clinical research, bribing physicians to prescribe the drug, use of key opinion leaders as disguised marketers, and manipulation of continuing medical education.  Other notable examples included Johnson and Johnson's campaign to sell Respirdal (look here),  and the infamous Pfizer campaign to sell Neurontin (look here and here).   Notably, stealth marketing seemed to be one reason for the growing popularity of narcotics (opioids) starting in the 1990s (look here). 

Such campaigns have gotten more exposure in the media and the scholarly literature, so we have not written as much about them in the last few years as previously.  So I confess we did not directly discuss a February, 2017,  investigative report by ProPublica about Precision Health Economics, a company that has orchestrated several such campaigns (although we did allude to it here).

Prof Tomas Philipson Named to President's Council of Economic Advisors

This week this report suddnely appears very salient, since Yahoo News just revealed that a top leader of Precision Health Economics, Prof Tomas Philipson, has been nominated to the President's Council of Economic Advisors by Donald Trump.

Donald Trump’s new senior economic adviser has helped pharmaceutical companies lobby to charge astronomical prices for crucial drugs.

Last Monday, the White House confirmed that Tomas J. Philipson, a health care economist, was joining the President’s Council of Economic Advisors.

That announcement was made just hours after Trump publicly accused Merck CEO Kenneth Frazier of charging patients 'ripoff prices' for drugs after he resigned from the President’s Manufacturing Council in protest at the president’s response to the violence at a white nationalist rally in Charlottesville, Virginia last weekend.

Now that Ken Frazier of Merck Pharma has resigned from President's Manufacturing Council,he will have more time to LOWER RIPOFF DRUG PRICES!

— Donald J. Trump (@realDonaldTrump) August 14, 2017


.@Merck Pharma is a leader in higher & higher drug prices while at the same time taking jobs out of the U.S. Bring jobs back & LOWER PRICES!

— Donald J. Trump (@realDonaldTrump) August 14, 2017

Precision Health Economics

Given the potential influence of Prof Philipson on the Council of Economic Advisors, it is worth summarizing what ProPublic said about his career at Precision Health Economics.

PHE as Orchestrator of Stealth Marketing and Policy Advocacy

First, the business of PHE is to help pharmaceutical and biotechnology companies market their products and influence public policy in their favor.

While collaboration between higher education and industry is hardly unusual, the professors at Precision Health Economics have taken it to the next level, sharpening the conflicts between their scholarly and commercial roles, which they don’t always disclose. Their activities illustrate the growing influence of academics-for-hire in shaping the national debate on issues from climate change to antitrust policy, which ultimately affect the quality of life and the household budgets of ordinary Americans — including what they pay for critical medications.

Furthermore,

'This is just an extension of the way that the drug industry has been involved in every phase of medical education and medical research,' said Harvard Medical School professor Eric G. Campbell, who studies medical conflicts of interest. 'They are using this group of economists it appears to provide data in high-profile journals to have a positive impact on policy.'

The firm participates in many aspects of a drug’s launch, both advising on 'pricing strategies' and then demonstrating the value of a drug once it comes on the market, according to its brochure. 'Led by professors at elite research universities,' the group boasts of a range of valuable services it has delivered to clients, including generating 'academic publications in the world’s leading research journals' and helping to lead 'formal public debates in prestigious, closely watched forums.'
Again, some people may naively imagine that academic publications are written by unbiased academics, not hired guns for industry, and that formal debates on major issues ought to again by led by people who are disintered and authoritative, not hired guns.  That would be very naive.

So PHE has set itself up as a vehicle to market and advocate on behalf of big corporations while making that work appear to be unbaised academic discourse.  In particular,

Precision Health Economics has counted at least 25 pharmaceutical and biotech companies and trade groups as clients. The roster includes Abbott Nutrition, AbbVie, Amgen, Biogen, Bristol-Myers Squibb, Celgene, Gilead, Intuitive Surgical, Janssen [a subsidiary of Johnson and Johnson], Merck, the National Pharmaceutical Council, Novartis, Otsuka, Pfizer, PhRMA, rEVO Biologics, Shire and Takeda.
Note that many of these companies are known for perpetrating the kinds of marketing shenanigans that we discuss on this blog.  See the links above.

 PHE Has Been Accused of Biased Work for Pharma Prettied by Its Principals' Academic Credentials

To justify the value of expensive drugs, the professors affiliated with Precision Health Economics rely on complicated economic models that purport to quantify the net social benefits that the drugs will create.

However,

Critics have at times questioned the assumptions underlying the consultants’ economic models, such as the choice of patient populations, and suggested that some of their findings tilt toward their industry clients. For example, some have tried and failed to reproduce their results justifying the value of cancer treatments.

Precision Health Economics allows drugmakers to review articles by its academics prior to publication in academic journals, said a former business development manager of the consulting group. Such prior review is controversial in higher education because it can be seen as impinging on academic freedom.

In addition,

About 75 percent of publications by the firm’s employees in the past three years have either been funded by the pharmaceutical industry or have been done in collaboration with drug companies, a ProPublica review found.

Some academics worry that a tight relationship with industry might suggest bias. 'I personally find, when your enterprise relies so substantially on a particular source of funds, you will tend to favor that source,' said Princeton economist Uwe Reinhardt.

Thus several of the firm's campaigns have produced considerable controversy.  For example,

Advocating Increased Pricing for Oncology Drugs

Precision Health Economics raised its profile in 2013 when the president’s annual economic report cited a cancer study by several of the firm’s principals and consultants. To some critics, though, the study showed how industry funding can taint academic research.

Originally published in Health Affairs, where [PHE founder Dana] Goldman also serves on the editorial board, the study found that Americans paid more for cancer care than Europeans but had better survival gains.

As the study acknowledged, it was funded by Bristol-Myers Squibb, a company that at the time was developing a much-anticipated cancer treatment. It was priced at more than $150,000 per year when it eventually came on the market. All three founders of Precision Health Economics were listed as authors of the Health Affairs article, alongside one of their employees, yet none of the founders disclosed their ties to their consulting firm in the published study. In an interview, Goldman said this might have been an 'oversight.'

In addition,

As the cancer study gained national recognition, its methodology and findings came under fire. Researchers from Dartmouth College tried and failed to reproduce the results. Cancer care in the U.S., their research found, may actually provide less value than cancer care in Europe, considering cost.

'We know that [the U.S. health care system] is more disorganized and disorganization is more expensive, so it’s surprising to believe that the U.S. would perform better in a cost-effectiveness sense,' said Samir Soneji, one of the authors of the counter-study and an assistant professor of health policy at Dartmouth. The science in the original study, Soneji says, was 'questionable.'

Soneji was not alone in his criticism. Aaron Carroll, a pediatrics professor at the Indiana University School of Medicine, reviewed the methodology and concluded that the Precision Health Economics researchers had used a measure that can frequently be misinterpreted. Instead of relying on mortality rates, which factor in a patient’s age of death, the study employed survival rates, looking at how long people live after diagnosis. Cancer screening, which can increase survival rates, is more frequent for some cancers in the U.S. than in other countries, Carroll says.

'When they wrote that paper using survival rates, they were clearly cherry picking,' Carroll told ProPublica. 'If the arguments are flawed and people keep using them, I would be concerned that they have some other motive.'

PHE Work on Behalf of PCSK9 Inhibitors

Not long after the controversy over its cancer research, Precision Health Economics became embroiled in another academic spat related to a client’s product. This time, it was over a breakthrough treatment that, injected one to two times per month, could help millions of Americans with high cholesterol. At the $14,000-per-year price set by one of its makers, Amgen, the PCSK9 inhibitor could also hike the nation’s annual prescription drug costs by an unprecedented $125 billion, or 38 percent. Its price in the U.S. is twice as much as in the U.K.

The U.S. price of the drug has come under vigorous attack from the nonprofit Institute for Clinical and Economic Review. ICER, which began as a small research project at Harvard Medical School, studies the cost-effectiveness of drugs, balancing their value to patients against the impact of their cost on society. The Centers for Medicare and Medicaid Services proposed a new rule in March 2016 that includes the use of value-based pricing studies, specifically citing the work of ICER.

The industry has attacked many of the institute’s studies, particularly those that find a treatment is overpriced. 

PHE orchesterated an attack on the ICER conclusions.

ICER concluded in 2015 that the new cholesterol treatment, the PCSK9 inhibitor, should cost about one-fifth what Amgen is charging. A few months later, Philipson, the Precision Health Economics co-founder, and Jena wrote an op-ed in Forbes, citing the institute’s research and deriding its approach to value pricing as 'pseudo-science and voodoo economics.' Only Philipson disclosed his ties to Precision Health Economics, and neither academic disclosed that Amgen was a client of the firm.

PHE Principals Have Failed to Disclose Their Conflicts of Interest

The professors’ disclosure of their ties to the firm and to the pharmaceutical industry in scholarly articles is inconsistent: sometimes extensive, sometimes scanty. Members of Precision Health tend to reveal less about their paid work in blogs, public forums like conferences, and legislative testimony. At the Capitol Hill briefing last May on hepatitis C drugs, Lakdawalla didn’t mention his affiliation with Precision Health Economics, though it was listed in the journal issue, which was provided to attendees.
One can argue that failing to disclose relevant conflicts of interest is deceptive.

Prof Philipson's Role in PHE has Increased in Scope

PHE was sold in 2015 to a "privately held biotech company, Precision for Value."  Since the sale, "Philipson is listed as chief economist and the chair of the strategy and innovation board."

A Problem Beyond the Revolving Door



We have frequently railed about the revolving door affecting health care.  Prof Philipson clearly will be transiting the revolving door, in that he will be going directly from a responsible corporate position into a government role in which we will be able to influence policy that affects the corporation in question (as well as other corporate interests, of course).  Nowadays, people frequently transit the revolving door from or to US government positions.  We most recently posted about the revolving door affecting health care in the current US administration here.

We previously opined about the revolving door....

The revolving door is a species of conflict of interest. Worse, some experts have suggested that the revolving door is in fact corruption.  As we noted here, the experts from the distinguished European anti-corruption group U4 wrote,


The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.
The ongoing parade of people transiting the revolving door from industry to the Trump administration once again suggests how the revolving door may enable certain of those with private vested interests to have excess influence, way beyond that of ordinary citizens, on how the government works, and that the country is still increasingly being run by a cozy group of insiders with ties to both government and industry. The latest cohort of revolving door transits suggests that regulatory capture is likely to become much worse in the near future.

So, as we have said before.... The continuing egregiousness of the revolving door in health care shows how health care leadership can play mutually beneficial games, regardless of the their effects on patients' and the public's health.  Once again, true health care reform would cut the ties between government and corporate leaders and their cronies that have lead to government of, for and by corporate executives rather than the people at large.


However, the case of Prof Philipson raises issues beyond the revolving door.  Prof Philipson is not a mere corporate executive.  He is a master of stealth marketing/ lobbying advocacy.  Stealth marketing, in particular, has been one of the scourges of US health care.

Back in a 2006 blog post about the stealth marketing of Neurontin, I wrote:

Physicians must be increasingly skeptical about educational and scholarly activities that may be disguised efforts at drug marketing.

Shame on the companies that have implemented such stealth marketing programs. Shame on the academic physicians who have taken money to help them out without revealing their financial interests to their physicians colleagues.

In a 2008 blog post about the same case, I wrote:

 This unfortunately is another blow to the current paradigm of evidence-based medicine. The EBM paradigm calls for physicians to make optimal decisions for individual patients based on their knowledge of the clinical context, the patients' values and wishes, and a critical review of the best relevant evidence from clinical research. For the paradigm to work, the assumptions are that all relevant research can be found, and that the research studies, while imperfect, were not intentionally designed or reported to deceive the reader. Yet the case of gabapentin adds to fears that relevant evidence that is unfavorable to the interests of the drug, device, or biotechnology company which sponsored the work is likely to be suppressed by that sponsor, and that commercially sponsored research is often deliberately manipulated to make its results appear more favorable.

Also, as Professor Dickersin noted (reported by the WSJ), "in exchange for being experimented upon in trials, patients are told they are contributing to human knowledge. To withhold negative results from the public breaks that ethical obligation to such patients...."

I began to think in the years after 2008 that the increasing exposure of stealth marketing (and related stealth lobbying and policy advocacy) campaigns would lead to their eventual decrease.  Never in my wildest dreams in 2008 did I foresee a stealth marketing master transiting the revolving door to be appointed to the President's Council of Economic Advisors.  (But then again, back then I would have laughed out loud at the notion of Donald Trump as President).  I seem to be really bad at prophecy.

We are slipping farther and farther from my ideal of true health care reform.  

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