A Little Sunshine Peeking Through the Clouds? - the Sunshine Act is Finally Implemented, Sort of

"Conflicts of interest" is probably the most frequently used Health Care Renewal tag.  We believe conflicts of interest are a major causes of health care dysfunction.  Therefore, I felt that one of the truly reformative aspects of the US Accountable Care Act (ACA, "Obamacare") could be the "Sunshine Act," a provision championed by Iowa Senator Grassley (R) and his staff investigator, Paul Thacker, that would require public reporting of most financial interactions among health care corporations and health care professionals and hospitals.

The roll-out of Sunshine Act implementation occurred this week, and not unexpectedly, was very rocky.   As reported by the Wall Street Journal,

it hasn't been a smooth process. First, CMS delayed the public reporting of the data by a year to give companies more time to prepare. The Open Payments online system has experienced technical problems, including a data mix-up that resulted in some doctors being linked to payment records for other doctors with the same surname. The preview function for doctors had a cumbersome registration process, some doctors said, and was taken offline at times in recent weeks.

The first batch of data is incomplete. CMS in August said it removed about one-third of the payment records from the physician-preview database because it said some of the state medical-license numbers that companies reported for doctors didn't match a database that the agency was using for verification, among other problems. CMS now is releasing those records but without identifying the physicians tied to them. It will update the database to include the physicians' names for those records next year. Also, CMS isn't immediately releasing payments related to proprietary research-and-development; those will be reported at a later date.

 But why should we have expected anything else, given the parties involved?

Drug, Device and Biotechnology Companies

As reported by the NY Times,

all manufacturers of drugs, medical devices and medical supplies that have at least one product covered by Medicare or Medicaid must report payments or gifts they make to doctors and teaching hospitals. This can be as seemingly trivial as a bag of bagels — all payments above $10 are included — or as lofty as a research grant. It also includes meals, travel expenses and speakers’ fees. Group-purchasing organizations, which serve as middlemen between health care providers and manufacturers, also must disclose doctors’ ownership and investment interests in their companies.

Presumably such reporting actually was quite burdensome to the companies.

Furthermore,company executives might not be exactly thrilled about putting all this information out there.  As we have frequently discussed, to serve their own interests, such companies make all sorts of payments to physicians, other health care professional, and hospitals and other non-profit health care organizations.  In particular, payments to health care professionals may foster companies' marketing and public relations goals.

While some payments are made for technical and clinical consulting, many are to support "education" that may serve marketing or public relations.  In particular, many payments are for "drug talks," that is, talks sponsored by the drug companies, usually through speakers' bureaus, and given probably not as part of formal, accredited continuing medical education.  Since the publication of "Dr Drug Rep" in the New York Times in 2007, it became evident that such talks emphasize content provided by the pharmaceutical companies, and are intended to be corporate marketing exercises.  From that case we also learned that physicians who deviate from the marketing message do not last long on speakers' bureaus.  (See posts here and here.)

In addition, pharmaceutical companies often pay physicians deemed to be "key opinion leaders," whose opinions are promoted supposedly for their brilliance and erudition.  However, as noted here and here, the companies buying their services think of KOLs as sales people.    Evidence about key opinion leaders actually performing like marketers has come from documents revealed during litigation (e.g., see this recent example of a huge monetary settlement made of charges that GlaxoSmithKline, a major multinational drug company committed fraud among other things, and in the course of its unethical activities used key opinion leaders as marketers).   Also, see the Neurontin marketing plan (see post here), and the Lexapro marketing plan (see post here) for examples of how corporate managers view key opinion leaders as marketers.

Pharmaceutical, biotechnology, and device companies protest that much of the money they pay goes to support research.  But the clinical research they sponsor has been shown to be frequently subject to manipulation designed to increase the likelihood of results favorable to these companies' products.  When manipulation fails to provide sufficiently favorable results, corporations may simply  suppress it.  Academic institutions desperate for more external funding, and physicians whose continued gainful employment at such institutions requires external funding may not be too quick to protest manipulation and suppression by those paying the bills.

Vox just summarized some of the relevant evidence:

Research for decades has shown that relations with industry — from industry-sponsored education to encounters with pharmaceutical-company sales representatives, and even drug samples provided by those companies — can bias a doctor's judgment in all sorts of ways. It can color the medical education they give to future doctors, cause them to inappropriately prescribe drugs, to push for the FDA approval of medicine, or for drugs to be included on their hospital formularies. Industry-funded studies are also four times more likely to lead to favorable and positive results than independent research.

The side-effects of this 'Bad Pharma' behavior range from waste in the health system, to mistreatment of patients, and even avoidable patient death.

So is it any surprise that industry may not have been enthused or comfortable about complying with the Sunshine Act?  Instead of admitting that, of course, they have complained, as reported by the NY Times,

the website is being questioned by the industry, which says that technical problems and data inaccuracies limit its value.

But it seems that industry may have created the sorts of data problems about which they now complain.  Note that when ProPublica made this first assessment of the database,

Many drug and device companies attributed payments to multiple subsidiaries, rather than reporting them under the name of a single parent company. Johnson & Johnson, for instance, submitted payments under at least 15 subsidiaries. The device maker Medtronic reported payments by at least six subsidiaries. So did the drug maker Novartis. On first blush, that makes it tough to calculate how much each company spent overall.

Similarly, companies reported payments associated with particular drugs in different ways. The expensive drug Acthar, which is marketed for a variety of different conditions, is listed under at least eight different name variations. The diabetes drug Januvia is reported as both 'Januvia' and 'Januvia Diabetes.' There is one drug simply listed as 'KNEES' and another as 'Foot and Ankle.'

So it appears that the companies reported data in a confusing, perhaps deliberately confusing manner, obfuscating the relationships between companies and subsidiaries, and between essentially similar drugs with different names.  It is hard to believe that all, or even most of these problems were due to mishandling by the government.  So it is a little hard to take the companies' criticisms of the quality of the data seriously.

Physicians and Organized Medicine

"We have met the enemy and he is us." - Pogo

On the other hand, news articles suggested some physicians were also unhappy with the data release.  For example, per the WSJ article,

Some doctors disputed details of the payment data. The database shows John LeDonne, a surgeon from Baltimore, as having received about $78,200 in payments for food and beverage for the five-month period from medical-device maker Dr. LeDonne acknowledged he performs paid consulting work for health-care companies including Teleflex, but that he rarely received free meals. He said the total payment amount was in the right 'ballpark,' but should not have been classified in the food-and-beverage category. 

That seems to be a bit of quibble.  The amount he received, and its source, seem more important than whether it was labelled "consulting," or "food and beverage" payments.

More importantly, a few doctors were worried, as reported by the Minneapolis Star-Tribune, that the information may reflect negatively on them,

 'Overwhelmingly, the interaction between industry and physicians is positive,' said Dr. Robert Harbaugh, chairman of neurosurgery at Penn State and president of the American Association of Neurological Surgeons.

Maybe Dr Harbaugh should realize that there already are a lot of reasons to think about the negative aspects of physician - industry paid interactions, as summarized above. And Vox reported,

 Dr. Thomas Stossel, known as Harvard's 'pro-industry professor,' says 'doctors' work with industry is necessary and beneficial.' He worries that the Sunshine Act could make it embarrassing and difficult for doctors to do work like developing medical devices or designing clinical trials, and that industry may start avoiding working with American doctors because of the time and investment disclosure will require.  

Dr Stossel did not provide evidence to explain the necessity or benefits of the work for industry, nor why doctors could not design clinical trials outside of industry relationships. 
Doctors also complained about data quality, but I am not aware that the medical profession rushed to help with improving the data for the Sunshine Act.  Obviously, there are some physicians who have personally profited quite a lot from their relationships with drug, device, and biotechnology companies but who may not be comfortable having the figures booted around in public, e.g., per the WSJ,

Among individual physicians, Stephen Burkhart was one of the top recipients of non-research payments from industry. The San Antonio orthopedic surgeon received $7.4 million in non-research payments or transfers of value for the five-month period, mostly from device manufacturer Arthrex Inc. for payments identified as 'royalty or license.'

Dr. Burkhart couldn't be reached for comment. Arthrex said in a statement that it has 'financial relationships with a number of orthopedic surgeons and teaching hospitals,' like many manufacturers, for their advice and expertise.

Chitranjan Ranawat,a New York orthopedic surgeon, received about $4 million in nonresearch payments or transfers of value, mostly from DePuy Synthes unit for 'royalty or license,' according to the database. 

 Dr. Ranawat couldn't be reached for comment.

And those were payments made in a five month period.  Maybe the doctors have a reason to be uncomfortable.

Furthermore, ProPublica reported that 21% of the $3.5 billion in payments, approximately $735 million, reported by the system were for "promotional talks," a la "drug talks" as noted above.  Since "Dr Drug Rep," such talks have gotten something of a bad reputation, but are obviously lucrative, so those who got paid to give them may not be happy with their detailed disclosure.

The US Department of Health and Human Services

The Sunshine Act was but a small part of the huge ACA, most of which the US DHHS, and particularly the Center for Medicare and Medicaid Services (CMS) was charged with implementing, but probably with proportionately insufficient funding and time.  So no wonder that the Sunshine Act never seemed to find a vocal champion within DHHS.

Most likely money concerns, and the constant din of outside criticism of "government bureaucrats" by those demanding more "business-like" government lead CMS to outsource the work on the Sunshine Act database, as described by another ProPublica article,

While the payments database is a far cry from Healthcare.gov — and less complex – it's reasonable to expect some glitches. CGI Federal, the company that led what turned out to be the botched launch of Healthcare.gov, is also responsible for the release of the payment data.

Massachusetts also outsourced operation of its Health Connector to CGI Federal, with equally bad results.  The state had to terminate the contract (look here.)

So if lackadaisical bureaucrats outsourced the Sunshine Act to contractors of questionable competence, what result should have been expected?

Why the present administration, and the bureaucrats it supposedly commands, seemed so uninterested in this particular aspect of the ACA is not clear, but perhaps we should peer around some revolving doors for the answer.  (For example,  John Podesta, a current White House adviser, worked for non-profits funded by drug company Eli Lilly and device company Synthes [look here]; and Nancy-Ann DeParle, former White House "health czar," had previously served on the boards of of Boston Scientific, Cerner and Medco [look here], and now is involved in health care investments made by private equity, and is on the board of CVS [look here]).

Of course, the sort of conflicts of interest that were supposed to be revealed by the Sunshine Act are highly beneficial to the parties directly involved, whatever embarrassment they may cause.  Given the power of those parties, plus the lukewarm, outsourced effort by government perhaps influenced by government officials with their own "revolving door" conflicts of interest, is it any wonder that the Sunshine Act implementation was "rocky?"

Summary

Nonetheless, because of the Sunshine Act, we do now know a bit more about conflicts of interest involving drug, device, biotechnology and related companies on one hand, and physicians, other health care professionals and hospitals on the other.

Maybe throwing even veiled sunshine on some of these relationships will inspire some people to rethink whether they want to continue them.  There are other reasons they should do so.

We have called endlessly for full, detailed disclosures of all conflicts of interest, for honesty's sake if for no other reason.  We have also called for severe curtailment of all conflicts affecting clinical decision making, health care education, clinical and health care research, and health policy making.  But Health Care Renewal can easily be dismissed as a voice crying out in the wilderness.  However, we are really not alone.

The 2009 Institute of Medicine report set relatively tough standards for managing conflicts of interest affecting clinical research and teaching, which unfortunately since have largely been ignored.  It did call for senior institutional officials to disclose their conflicts of interest, and for institutional boards of trustees to form conflicts of interest committees that would exclude conflicted individuals, but otherwise did not address conflicts of interest affecting academic leaders or institutional trustees.  The 2013 Pew Charitable Trusts Conflicts-of-Interest Policies for Academic Medical Centers suggested restrictions on conflicts affecting faculty, trainees, and students, but again did not mention senior institutional leaders or boards of trustees.  Implementing even some of these recommendations would be true health care reform.

Maybe more publicity about the web of conflicts of interest that drapes of over health care will lead to some further steps in the needed direction. 

Big Door Keep Revolving - Our Latest Roundup About the Blurred Lines Between the Health Care Industry and the Government Bodies that are Supposed to Regulate and Make Policy Affecting It

The revolving door continues to turn connecting US government bodies that make health policy or regulate health care and the health care industry.  Sometimes these transitions are obvious, sometimes they are obscure.  The press sometimes makes the revolving door the subject, but more often it is just an aside.

The latest roundup of transitions through the door includes, in chronological order of media attention...

Former White House Press Secretary to Consultancy Serving Health Care Corporations

As reported by the Washington Post in April, 2014, Robert Gibbs was White House Press Secretary until he departed for the private sector,

Since departing the White House in 2011, Gibbs has taken a path familiar to other former White House officials who use their ties to a president to enrich themselves and establish a new career. 

In particular, he

co-founded The Incite Agency, a consulting and media relations firm that advises Fortune 500 companies, including health-care firms.

The story was apparently generated after the Democratic House Minority Leader openly criticized someone who served in the Democratic President's White House, so the thrust of the story was about how Mr Gibbs has apparently changed his ideas on Obamacare since his White House days,

House Minority Leader Nancy Pelosi (D-Calif.) suggested Sunday that former top Obama aide Robert Gibbs's comment that the employer mandate portion of the Affordable Care Act won't survive might be related to Gibbs's business interests.

'I don't know who his clients are or what his perspective is,' Pelosi told CNN's 'State of the Union.' 'But we are celebrating the fact that we have over seven million who have signed up.'

The Post also noted,

The speech Gibbs gave this past week in Colorado is consistent with how the Harry Walker Agency bills Gibbs as a potential paid speaker. On its Web site, pitches Gibbs by noting that he 'played a major role in the daily White House policy debates over the shape of healthcare reform.' It suggests that during such speeches, Gibbs 'articulates the future for the Patient Protection and Affordable Care Act.'

The pitch concludes by stating that 'The future of Obamacare -- and how it will affect your business -- is yet to be seen, and few are better prepared than Gibbs to guide you through that conversation.'

Again, note that this article seemed to be inspired by Rep Pelosi's direct criticism of a fellow Democrat, not by the revolving door transition per se.  

President of Global Government and Scientific Affairs at Natural Products Association to Director of the Division of Dietary Supplements at the FDA then Back to Natural Products Association as CEO

This round trip through the door was noted rather obliquely in a New York Times article in late April, 2014, focused on how slowly the FDA has reacted to apparently dangerous "dietary supplements,"

Before joining the F.D.A. in 2011, Dr. [Daniel] Fabricant was a top executive at an industry trade group, the Natural Products Association.

The article had previously identified Dr Fabricant as

the director of the division of dietary supplement programs in the agency’s Center for Food Safety and Applied Nutrition.

But,

The F.D.A. recently announced that Dr. Fabricant is leaving the agency this month to return to the trade group as its chief executive.

While the NY Times article thus mentioned as an aside that a government official with major responsibility for regulating dietary supplements had these relationships with the dietary supplement industry, it did not question whether that relationship had anything to do with slow responses by the FDA to reports of toxic dietary supplements. 

Spokesman for the Speaker of the House of Representatives to Spokesman for America's Health Insurance Plans

USA Today briefly but directly noted this in mid-May, 2014,

House Speaker John Boehner’s spokesman, Brendan Buck, has spent a lot of time over the years helping his boss and congressional Republicans criticize President Obama’s health care law.

Now Buck is leaving Capitol Hill to be spokesman for America’s Health Insurance Plans, the trade association that represents thousands of health insurance companies.

'Brendan’s experience and skill set will allow him to hit the ground running on Day One,' said Karen Ignagni, president and CEO of AHIP. 'He’s an effective communicator who knows how to tackle complex policy issues and skillfully navigate an ever-changing health care and media environment.'

What made this interesting seems to be how it represented a change of tune on Mr Buck's part.  Note that many people believe that commercial health insurers will benefit from all the new policy holders that Obamacare sends them, so

As the health insurance  industry’s trade group, AHIP supports the law’s mandate that individuals obtain health insurance. The trade group has praised the Affordable Care Act’s ability to expand insurance coverage.

But never mind that the man in the government for whom Mr Buck previously worked,

Boehner likes to call Obamacare a 'train wreck.'

FDA Director of the Office of Medical Policy for the Center for Drug Evaluation and Research to Greenleaf Health Consultancy

This so far has appeared only in a mid-May, 2014,  press release.   It describe Dr Sherman's career at the FDA,

During her FDA tenure, Sherman was a driving force for innovation, new programs and policy. Sherman was responsible for spearheading and implementing the Sentinel Initiative, the Critical Path Initiative, biosimilars policy and the new Breakthrough Therapy Designation.

As Director of CDER’s Office of Medical Policy and Associate Center Director for Medical Policy Sherman was responsible for developing, coordinating, and implementing medical policy programs and strategic initiatives as well as establishing and chairing CDER's Medical Policy Counsel [sic]. This included overseeing the regulation of prescription drug promotion and advertising.

Sherman began her career with FDA in the Division of Antiviral Drug Products at CDER in 1989—first as a medical reviewer and then as a clinical team leader. In 1998, she was appointed Deputy Office Director for the Office of Drug Evaluation I. In 1999, she assumed the duties of Deputy Office Director for the newly established Office of Medical Policy in CDER. 

But now she will be "Principal, Drug and Biological Drug Products" for Greenleaf, described as,

Greenleaf Health is a full service regulatory consulting firm that provides strategic guidance to companies regulated by the FDA and those developing innovative solutions to pressing public health challenges around the globe

Note that Greenleaf was already well populated with FDA officials who had previously transited the big revolving door,

Patrick Ronan, former FDA Chief of Staff and currently president of Greenleaf; Dr. Daniel Schultz, former Director of the Center for Devices ('CDRH') and Radiological Health and currently Greenleaf's Principal for Medical Devices and Combination Products; Michael Chappell, former Associate Commissioner for Regulatory Affairs, and currently Greenleaf's Principal for Regulatory Compliance; Heather Rosecrans, former Director of CDRH's 510(k) staff and currently Senior Vice President for Medical Devices and Combination Products; Linda Carter, formerly Associate Director of CDER's Office of Evaluation I and currently Vice President of Drug and Biological Drugs; and Taryn Fritz Walpole, former FDA Deputy Chief of Staff, and currently Chief Operating Officer and Senior Vice President for Regulatory Affairs

So maybe it has become so routine for middle and upper level FDA managers to go to work for consultancies that help industry to deal with the FDA that no journalist found this revolving door transition interesting.

Summary

Again, there appears to be constant traffic among health care corporations and the government bodies that regulate them and make policy that affects them.  The traffic may be so heavy and routine that it no longer appears to be news, unless accompanied by an ironic detail or two.

However, as we have said many times before, the constant interchange of health care insiders among government, large health care corporations, and the consultancies, marketing, public relations, lobbying and legal firms which represent them certainly suggests that health care, like many other sectors, seems to be run by an amorphous group of insiders who owe allegiance neither to government nor industry.

However, those who work in government are supposed to be working for the people, and those who work on health care within government are supposed to be working for patients' and the public health.  If they are constantly looking over their shoulders at potential private employers who might offer big checks, who indeed are they working for?

Attempts to turn government toward private gain and away from being of the people, by the people, and for the people have no doubt been going on since the beginning of government (and since the Constitution was signed, in the case of the US).  However, true health care reform  would require curtailing the severe sorts of conflicts of interest created by the revolving door.

Real heath care reform would require multi-year cooling off periods before someone who worked in the commercial world can get a job in a government whose work has direct effect on his or her previous employer or industry sector, and before someone who worked in government whose work had direct effect on a particular economic sector can accept a job for a company in that sector.   

Is this Any Way to Discuss Health Care Policy? - Television Advertising about US Health Care Reform Cost $445 Million from 2010 -2014

Every now and then, we get an anonymous comment criticizing our "lack of balance" or words to that effect, maybe because we criticized some action by a big, often but not always for-profit, health care organization.  We usually respond that we have no obligation to be balanced, since
- We publish opinion, not hard news
-  It is questionable that even hard news reporters must report all opinions on an issue, if some of those opinions are demonstrably less credible
-  There are far more voices extolling the wonderful "innovations" provided by our current "best health care system in the world," than providing our sorts of criticism.

To expand on that last point - a recent news item suggests how much of the health care policy debate is paid marketing and public relations, rather than individual voices of citizens, health care professionals, or even health care policy experts.

From the AP, via the Seattle Post -Intelligencer,

A new analysis finds the nation's health care overhaul deserves a place in advertising history as the focus of extraordinarily high spending on negative political TV ads that have gone largely unanswered by the law's supporters.

The report, released Friday by nonpartisan analysts Kantar Media CMAG, estimates $445 million was spent on political TV ads mentioning the law since the enactment of the Affordable Care Act in 2010. Spending on negative ads outpaced positive ones by more than 15 to 1.

In particular,

In the 2014 congressional races, 85 percent of the anti-Obama ads were also anti-'Obamacare' ads, the analysis found. In some competitive races, 100 percent of the pro-Republican TV ads aimed at Democrats contained anti-health law messages.

Over the four years, an estimated $418 million was spent on 880,000 negative TV spots focusing on the law, compared to $27 million on 58,000 positive spots, according to the analysis. Nearly all of the spending was on local TV stations, in races ranging from state offices such as treasurer and governor to Congress and the presidential election.

That is just amazing.

My concern is not so much that much of this advertising is against "Obamacare."  We have not often written about the Affordable Care Act (ACA), aka "Obamacare," and what we wrote at best was mild praise.  As I posted back in 2009, very little of the law had anything to do with the issues we discuss on Health Care Renewal.  In my humble opinion, since the law went into effect, it has increased access to health insurance, especially for certain groups of people that commercial health care insurers previously spurned, e.g., older people and people with pre-existing diseases.  It also contained provisions that might increase disclosure of conflicts of interest, and foster comparative effectiveness research.  On the other hand, the law has done nothing to reduce concentration of power in health care.  It has done nothing to make health care leaders more accountable, especially for their organization's unethical or even criminal behavior, decrease their ability to line their pockets regardless of such behavior, and thus reduce their impunity.  It will not obviously decrease conflicts of interest affecting those who make decisions about patient care or health policy, lock the revolving door between government and the health care industry, end manipulation of clinical research to serve vested interests, or suppression of research whose results offend such interests, etc, etc.  So there is plenty to discuss about health care reform and related matters of health care policy.

Yet a major venue of US public discussion about health care policy, at least having to do with health care reform legislation, appears to be 15 -60 second paid television advertisements.  Often who pays for these ads are obscure, as certainly are the identities of the advertising or public relations firms that actually craft them.  Certainly, the ads do not explain who might profit were what they urge be implemented. The ads may appeal to emotion, or engage in logical fallacies.  And they appear in millions of peoples homes day in and day out.

Such advertising, added to all the other billions of dollars worth of marketing and public relations that swirl around health care, make any sort of intelligent discussion very difficult.  The advertising frenzy renders the voices of individual citizens, health care professionals, and even health policy experts  whispers in comparison.

While there are ostensible free speech advocates who defend these advertisements, and maybe who promote the free speech rights of corporations as the same as those of human citizens (without, of course, many of the responsibilities of citizens), none of these vocal self-proclaimed civil libertarians seem to be doing anything to defend the audibility of the voices of individuals in the health care policy debate.

So we will continue to do what we can to bring some healthy skepticism about loud proclamations in health care made by people who stand to gain financially from their effects.  But is it any wonder that our voices create so few echoes?

Marketing Bad Health Care Decisions as a New Form of Stealth Health Policy Advocacy

A remarkable set of video advertisements appeared a few weeks ago that seem designed to frighten people into making bad health care decisions.

The "Bad Uncle Sam" Advertisements

As described by Businessweek,

In the first ad, dubbed 'The Exam,' a young woman who has signed up for Obamacare arrives at a medical facility and changes out of her clothes and into a flimsy hospital gown. Following the instructions of a doctor, she reclines on a hospital bed and spreads her legs into a pair of stirrups. The doctor leaves the room. Then, suddenly a mascot wearing a plastic Uncle Sam mask and sporting an unwavering grin—Creepy Uncle Sam!—pops up between her legs. As she screams, the ad pans out. 'Don’t let government play doctor,' reads the kicker.

The final message, for some reason not described by Businessweek, was

Opt out of ObamaCare

Similarly,

A second spot, entitled 'The Glove,' follows a similar narrative arc. A young man sits in an examination room and tells a doctor that he’s signed up for Obamacare. 'I saw the ads and figured, why not?' he says. 'Okay,' says the doctor. 'Take your pants off.' The man drops his trousers, reclines on the hospital bed, and brings his knees to his chest. The doctor leaves the room. Behind the young man, Creepy Uncle Sam pops up, raises his hand into the air, snaps on a latex medical glove, and wiggles his fingers menacingly.

Once again, the final message is

Opt out of ObamaCare

The Ostensible Message of the Advertisements

Again per Businessweek, the ads were sponsored by " Generation Opportunity, a Virginia-based conservative organization funded in part by Charles and David Koch,..."  According to an article on the Atlantic website, Generation Opportunity means to be

urging Millennials not to sign up for insurance on the health care exchanges created by the Affordable Care Act. It claims that paying the individual mandate's tax penalty and buying insurance that doesn't meet government coverage rules is a 'better deal' for young people.

As many have noticed, that is not the implication of the visuals.  As an opinion piece in the National Journal put it,

 the message is that the government is trying to forcibly rape women with a blunt metal instrument.

Furthermore, the final written message of both advertisements is not a nuanced one about where one should seek to go to buy health insurance.  It is simply "opt out of ObamaCare."

A Nonsensical Premise

Also, the premise of the advertisements is nonsense, to put it politely.

ObamaCare does require health insurance to pay for various kinds of preventive care without requiring patients to pay deductibles.  It does not make physicians and nurses provide these services.  Whether a patient gets, for example, a pelvic exam, is up to that patient and her doctor or nurse practitioner, not the government.  Of course, the legislation does not remotely suggest creepy government agents should perform pelvic or rectal exams. 

Thus, the entire point of these advertisements seems to be to generate irrational fears that will drive young people away from health insurance now available through ObamaCare.

Stealth Health Policy Advocacy by Means of Marketing Bad Personal Health Care Decisions

In the US, the Affordable Care Act, aka ObamaCare, still arouses a lot of controversy.  There are many people who have been critical of various aspects of the law.  (In fact, we criticized it for not addressing most of the issues about which we write on this blog.)  Furthermore, there is at least a large minority who want to repeal the law.  So there has been an ongoing barrage of persuasive messages meant to support or criticize various aspects of the law, and to support or discredit the entire law.

However, the "Bad Uncle Sam" advertisements are different.  They do not urge people to vote for any particular person or initiative.  They do not urge people to express their own policy views.  They do not ask for contributions to political or advocacy organizations.

Instead, they urge people to make particular health care decisions.  Despite the more nuanced messages espoused by Generation Opportunity when interviewed, their advertisements try to irrationally scare people away from purchasing health insurance made available by ObamaCare.

They are aimed at young adults, who are less likely to have spare funds to pay for expensive health insurance, less likely to get sick or injured, and more likely to feel relatively invincible.  However, were an uninsured person, even a young one, to suffer a significant illness or injury, the resulting costs in our dysfunctional and extremely expensive health care system could drive them bankrupt.  This is all the more likely since the uninsured are likely to be charged "rack rates" for health care, while insurance companies negotiate discounts for their subscribers.  Furthermore, uninsured people may put off needed tests and treatments due to financial concerns, yet doing so may lead to worse health care results, or even death.

An article in the St Louis Post succinctly listed the costs associated with some unlucky outcomes for uninsured young people, for example, 

Suppose you twist your knee playing soccer. Without coverage, fixing it will be at least $20,000 to repair the ACL ligament, according to an estimate from Costhelper.com.

Can’t pay it? Buy some crutches. They run about $30. You’ll also take on the risk of tissue damage and early arthritis.

Personal finance columnist Jim Gallagher concluded,

 although the vast majority of young adults stay healthy, serious trouble is not rare. Those without insurance are playing the odds. If they win, they’ve saved the insurance premiums. If they lose, they’re ruined.

Generation Opportunity may claim to be

 a free-thinking, liberty-loving, national organization of young people promoting the best of Being American: opportunity, creativity and freedom. 

However, what it appears to be doing is urging bad health care choices  based on a false premise to serve an ideological agenda.

Thus, its advertisements are a unique and uniquely bad mixture of marketing (of bad decisions) and stealth health policy advocacy.  If they want to publicly oppose ObamaCare, that is their right.  Fooling people into making bad decisions in the hopes that this will financially burden ObamaCare is completely unethical and amounts to disinformation, in my humble opinion.  The leadership and funders of Generation Opportunity ought to be ashamed of themselves.

The US has many major health care problems.  They deserve discussion and debate.  Disinformation that tries to confuse people into making bad personal health care decisions is likely to make our health care dysfunction even worse.  

Round and Round Spins the Revolving Door, Unimpeded by "Obamacare," Nor By Those Protesting "Obamacare"

On this day of government dysfunction in the US, it is time for our latest installment on the "revolving door," the interchange of insiders among government legislative offices that affect health policy and agencies that implement it, and large health care corporations and the lobbyists and attorneys who represent them.  While we have been discussing this issue since March, 2011 (look here),  it got major media attention in the form of a New York Times article two weeks ago.

We have accumulated several other relevant stories since late August, 2013, which we will group by the type of government offices and agencies affected, and within them, by the date the story first came out..

Regulatory and Law Enforcement Agencies

Health Care Antitrust Leader at the Federal Trade Commission to Arnold & Porter

 From the MainJustice.com site,

Peter J Levitas, a former senior antiturst attorney at the Federal Trade Commission, is joining Arnold & Porter LLP in Washington, D.C....

Levitas has spent the past four years as deputy director of the FTC's Bureau of Competition and oversaw investigations and litigation for mergers and conduct cases in numerous industries.  

So,

Levitas joins the firm's antitrust practice with experience3 addressing complex merger and conduct investigations, particularly in the healthcare, pharmaceutical and technology industries.

Leader of Health Care Fraud Enforcement for US Attorney New Jersey Office to Lowenstein Sandler

From the ComplianceWeek.com site,

Maureen Ruane, a former health care fraud chief at the U.S. Attorney's Office for the District of New Jersey, has rejoined the law firm Lowenstein Sandler to lead its new health care litigation, investigations and compliance practice.

The new practice will help the firm's healthcare and life science clients strengthen their regulatory and compliance programs, as well as defend corporate and individual clients who become the subjects or targets of government investigations or enforcement actions. 

Prior to rejoining Lowenstein Sandler, Ruane most recently served for more than three years as the Chief of the Health Care & Government Fraud Unit at the U.S. Attorney's Office for the District of New Jersey.

Health Policy Implementation

Counsel for Department of Health and Human Services to Sidley Austin

Per the NY Times, 

Dr. [Dora] Hughes, a former Obama administration official, has something Washington lawyers and lobbying shops covet: an insider’s understanding of the new health care law. After nearly four years as counselor to Health and Human Services Secretary Kathleen Sebelius, she left government last year to work for Sidley Austin, which represents insurers, pharmaceutical companies, device makers and others affected by the law. 

Previously,

she  began a decade ago, first as a health policy adviser to Senator Edward M. Kennedy, and later to Mr. Obama, then a senator.

Deputy Assistant Secretary of Department of Health and Human Services to Glover Park Group

Also from the NY Times,

 Elizabeth Engel, who oversaw health legislation and served as a liaison to Congress when she was a deputy assistant health secretary under Ms. Sebelius, is now advising health care clients for the Glover Park Group.

White House to Avenue Solutions

From the NY Times,

Yvette Fontenot, a mother of three who began her Washington career in 1997, analyzing Medicare for the Office of Management and Budget. Ms. Fontenot worked on the health bill as a Finance Committee aide and later moved to the White House. Four months ago she joined Avenue Solutions, a boutique lobbying shop. 

White House "Health Czar" and Deputy Chief of Staff to Consonance Capital, and CVS

While we noted this in August, 2013, the NY Times reported in September as part of its larger article, 

   Nancy-Ann DeParle, Mr. Obama’s former 'health czar' and later his deputy chief of staff, now guides health care investments as a partner in a new private equity firm, Consonance Capital, with colleagues from her pre-White House days. 

Actually, as we discussed in 2009, Ms DeParle has been oscillating back and forth through the revolving door for a while.  She  was the administrator of the Health Care Financing Administration in the Department of Health and Human Services under President Clinton from 1997-2000.  She left to become managing director of a private equity firm, CCMP Capital.  She also served on the boards of directors of Boston Scientific, Cerner, and Medco.  Then she went back to the executive branch as noted by the the Times above.

Furthermore, as reported by AP, via the Providence Journal,

Drugstore chain CVS Caremark has added to its board of directors a former top adviser to President Barack Obama on the health care overhaul.

The Woonsocket, R.I., company said Wednesday after markets closed that Nancy-Ann M. DeParle, 56, will be an independent director who serves on the board's audit committee.

White House to health care venture capital

Also from the NY Times story,

Bob Kocher, a doctor, management consultant and former member of Mr. Obama’s economics team, is a California venture capitalist, helping finance health start-ups.

Legislative Offices

Senate Finance Committee Staff, then Department of Health and Human Services Staff to Avenue Solutions

As reported by The Hill bog,

The firm Avenue Solutions, for instance, recently hired Yvette Fontenot, a former staffer for both the Senate Finance Committee, which wrote ObamaCare’s tax-related provisions, and HHS's Office of Health Reform, which is assisting the implementation.

Since her hire in April, the four-woman firm has picked up Health Care Service Corp. as a client, and Fontenot is now lobbying for the Blue Cross Blue Shield Association

Congress to Alston & Bird

In the same report,

Former Rep. Earl Pomeroy (D-N.D.) joined Alston & Bird in 2011 after dealing with healthcare and tax issues as a member of the House Ways and Means Committee.

Now Pomeroy and his one-time chief of staff, Bob Siggins, are lobbying on ObamaCare for clients such as clients such as Vision Service Plan, the National Coordinating Committee for Multiemployer Plans and Medicare — a health insurance provider.

Health Counsel for Senate Finance Committee from WellPoint, Now to Johnson & Johnson

Note that we touched on part of this story back in 2010 here.  Now from the New York Times, 

Liz Fowler, a onetime executive with WellPoint, the insurer, helped draft the legislation as the chief health counsel for the Senate Finance Committee and later joined the administration. Now she runs global health policy for Johnson & Johnson, the medical equipment and pharmaceutical giant, which strongly backed the health bill and stands to benefit from it. 

Ms. Fowler is not a registered lobbyist, but she does provide in-house advice on the bill — work that has drawn criticism from publications like the British newspaper The Guardian and the Web sites Salon and The Huffington Post, where the journalist Bill Moyers singled out Ms. Fowler, asserting that 'when push comes to shove, corporate interests will have the upper hand.'

Summary

 It's enough to make one's head spin: all that traffic through the revolving door reported just in the last five weeks.

As we have said many times before, the constant interchange of health care insiders among government offices, lobbying and legal firms, and large health care corporations certainly suggests that health care, like many other sectors, seems to be run by an amorphous group of insiders who owe allegiance neither to government nor industry.  The NY Times tried to explain this in a benign way,

Yet the progression from government to the private sector is also predictable, a window into the peculiar rhythms of life in the capital. Young aides, often fresh out of college or graduate school, acquire highly specialized knowledge but eventually settle down, build lives and long for jobs that pay more and let them see their children at night. 

While the private sector may offer good pay, is it just for these poeples' skills and expertise?  Or are these offers only for those who while in government service evinced friendship to private vested interests?  Do government workers who think longingly of higher pay and shorter hours wonder what it would take to please those that might offer such opportunities?

Yet those who work in government are supposed to be working for the people, and those who work on health care within government are supposed to be working for patients' and the public health.  If they are constantly looking over their shoulders at potential private employers who might offer big checks, who indeed are they working for?

Attempts to turn government toward private gain and away from being of the people, by the people, and for the people have no doubt been going on since the beginning of government (and since the Constitution was signed, in the case of the US).  However, true health care reform  would require curtailing the severe sorts of conflicts of interest created by the revolving door.  This might require both improving pay and working conditions for government regulators, law enforcers, and legislative staffers; and specific laws to prevent immediate transitions from being a regulator, law enforcer, or legislator to handling corporate responses to or defenses against such regulation and enforcement. 

That bit does not seem to be part of the current Affordable Care Act, yet it was hardly to enact such restrictions on conflict of interest that certain members of Congress have shut down the government.  

What Sorts of People are "Most Influential in Healthcare?"

Modern Healthcare just put out their list of the "100 Most Influential People in Healthcare" for 2013.  A look at what sorts of people are on this list says a lot about who runs US health care, and raises questions about who should.

Some Health Care Professionals, Lots of Hired Managers

I did some quick descriptive categorizations. (Counts were double checked but I am not guaranteeing accuracy.  Categorizations were sometimes difficult for highly diversified organizations.)

First, less than one third of list members are physicians (31% by my count).  I did not see any other health professionals on it (although I confess I did not look up the biographies of all 100).

Of these physicians, most are now functioning as hired managers, usually at the CEO level, of big health organizations.  I found only a few who could be characterized as somewhat academic: Dr Atul Gawande, professor at Harvard Medical School, Dr Eric Topol, chief academic officer at Scripps Health, Dr Harvey Fineberg, President, Institute of Medicine, Dr Brent James, chief quality officer and executive director, Institute for Health Care Delivery Research, Intermountain Healthcare,  and probably Dr Jeffrey Drazen, editor-in-chief of the New England Journal of Medicine. 

My counts of hired managers on the list included

CEOs of For-Profit Health Insurers - 5%

CEO of For-Profit Hospital Systems - 8%

CEOs of Non-Profit Hospital Systems - 21%

CEOs of Other For-Profit Care Delivery Corporations - 7%

CEOs of Drug/ Device/ Medical Supply Corporations - 2%

CEOs of Health Care Information Technology Corporations - 1%

CEOs of Non-Profit Trade Associations - 14%

CEOs and other Leaders of Professional or Medical Association - 5%

CEOs of Health Care Charities - 4%

CEOs of Other Non-Profit Organizations - 15%

Elected Government Leaders - 6%

Leaders of Government Agencies, Departments - 10%

Union Leaders - 2%

People Whose Organizations Have Issues

The list included quite a few people who lead organizations which have had issues of the sort we discuss on Health Care Renewal.  For example, the list included the following among its top 10 most influential, in order of listed influence -

4.  Stephen Hemsley, CEO of UnitedHealth Group - We have discussed concerns about his executive compensation and how it does not fit his organization's stated mission, or his organization's long list of ethical misadventures (most recently summarized here)

6. Mark Bertolini, CEO, Aetna - We most recently discussed how Aetna's leaders' pontifications on health policy seem mainly based on self-interest (here)  We also discussed various other management, ethical and legal issues.

7.  Richard Bracken, CEO, HCA - A long time ago, HCA was one of the first big health care corporations to have to make a billion dollar plus settlement for fraud, among other issues (look here).  The company has had legal, ethical, and management issues since.

8.  Joseph Swedish, CEO, WellPoint - He is new as CEO, but under previous leadership, the company amassed a record of misadventures while making its leadership very rich (summarized here, and look here for details.)

The list also included many other people whose organizations have been frequent fliers on Health Care Renewal.  For example, the CEOs of Epic Systems (ranked 13),  Tenet Healthcare (18), Cigna (20), McKesson Corp (24), Sutter Health (42), Johnson & Johnson (46), Pharmaceutical Research and Manufacturers of America (PhRMA) (48), HealthSouth (59),  UPMC (69), and  Steward Health Care System (86).

There are many other people on the list who lead organizations that have gotten unfavorable notice on this blog, and a few whose own extreme executive compensation garnered comment.  As my science professors used to say, I leave their identification as an exercise for those interested.

Who Is Not on the List

It is interesting who is not on the list.  There are no physicians in private practice.   I would argue there are no physicians who are "pure" academics at the moment.  There are no other health care research, health policy research, or public health academics.

I saw only one person on the list (Senator Charles Grassley - R, Iowa) who has been identified with the sorts of real health care reforms we discuss here.  (Senator Grassely has investigated many instances of alleged conflicts of interest and fraud, and sponsored the Sunshine Bill to disclose better physicians' conflicts of interest.)  I do not see anyone else who in my humble opinion is identified as a dissident within the current environment. 

Many of the media accounts we have noted include people identified as experts who decried such issues as excessive executive compensation, mission-hostile management, conflicts of interest, ethical issues leading to legal settlements, or crime and corruption in health care.  None of them save Senator Grassley  are on this list. 

Summary

The Modern Healthcare list of 100 most influential people in health care demonstrates the enormous influence of hired managers in modern health care.  The vast majority of list members were hired managers.  While the list did include some physicians, most of them were currently working as hired managers.

It also demonstrates the influence of the for-profit, industrial part of health care.  It included 5 for-profit insurance CEOs, 8 for-profit hospital corporation CEOs, 7 for-profit health care delivery corporation CEOs, 2 for-profit drug/device company CEOs, and 1 for-profit health care IT CEO, a total of 23.  It also included CEOs of multiple trade associations, some of which represent the for-profit side of health care (e.g., PhRMA, America's Health Insurance Plans).  While it included leadership of many non-profit organizations as well, some of these organizations have clear financial links to the for-profit industrial side.  These ties may include significant financial support from industry, significant holdings of health care corporate stock, or managers or board members with their own relationships to industry.  (For example,  see this discussion of conflicts of interest affecting the Gates Foundation, whose co-chair is 76 on the Modern Healthcare list.)  Many of the large, non-profit hospital systems, 21 of whose CEOs are on the list, have major institutional conflicts of interest, and have many people with individual conflicts of interest among their leadership and on their boards of trustees.

As opposed to the influence of the for-profit industrial part of health care, the influence of government seems muted.  The list included only 6 politicians and 10 government managers.  Some of the politicians are notable proponents of smaller government, e.g. Senator Grassley, and specifically of a smaller role of government in health care, e.g., Governor Bobby Jindal, R, Louisiana.    Nor do unions have much influence.  Only two union leaders were on the list.  There was little counterweight provided to industrial influence from academia, and an almost complete absence of those who might question the current US status quo of dominance of health care by commercial interests. 

So here is the latest evidence that US health care is dominated by commercial interests (in an era of regulatory capture, revolving doors, and financialization) and professional, if often generic managers.  This suggests why our health care system seems more about revenue (and thus is very expensive), and less about improving patients' and the public's health.  True health care reform would require increasing the influence of people who have different priorities than the currently most influential. 

The Door Revolves Again: the Former White House Health Reform Czar Goes to Private Equity Firm Looking for Investments Created by Health Reform

Round and round it goes, and when it will stop, nobody knows.

Background: The Former Health Care Reform Czar's Past Career

It appears that Ms Nancy DeParle, formerly a White House Deputy Chief of Staff, and before then, from 2009 - 2011, the Director of the White House Office of Health Care Reform, has gone through the revolving door again.

We raised concerns about Ms DeParle's strong ties to the commercial side of health care at the time she was put in charge of getting health care reform legislation passed (look here.)  Specifically, her background for shepherding this legislation included being on the boards of directors of three large health care corporations, Boston Scientific, a medical device company, Cerner, a vendor of health care information technology, and Medco, and pharmacy benefits company.   She had previously been on the boards of DaVita, a commercial kidney dialysis care delivery company, and Triad Hospitals, a for-profit hospital system.  At the time, I wondered whether this set of relationships with multiple  health care corporations would lead to "health care reform" that was more about the interests of big health care corporations and their top executives than about us, the people.

As it turned out, there is a case to be made that a lot of the health care reform legislation that eventually passed was in the interests of big corporations.  It enabled for-profit health care insurance companies to continue to dominate the insurance market, and created no "public option" that could have competed with them.  It fostered the development of "accountable care organizations," (ACOs), and thus fostered a wave of consolidation in the hospital market favoring ever larger hospital systems, including for-profit ones, and the rise of the corporate physician.  It pushed the use of commercial health care information technology without requiring these devices' effects on patients to be rigorously assessed, and with no obvious concerns about the risks posed by these systems.  It did nothing to stop concentration of power in health care, nothing to support small private practices, small non-profit hospitals, or non-profit health insurance.  While it required more disclosure of conflicts of interest affecting physicians, it did nothing to reduce them, or to combat deception in health care marketing and public relations, or to reduce manipulation or suppression of clinical research to serve commercial vested interests, or even to combat blatant health care corruption.

A Brief Stop at a Think Tank

At any event, Ms DeParle left the government early this year.  She did not immediately go back to the commercial world, however.  Instead, as reported by The Hill, she went to a think tank.

Nancy-Ann DeParle, a White House deputy chief of staff and the president's point person on his signature health care law, is leaving the West Wing to join the Brookings Institution. 

Brookings president Strobe Talbott announced in a post on Twitter that the longtime Obama staffer would work as a guest scholar for the think tank.

Through the Revolving Door to Private Equity

That position did not last long, however.  A few days ago, a Wall Street Journal blog announced she was moving again,

As health care-focused private equity firms navigate the nuances of the Affordable Care Act, one such shop, Consonance Capital, has decided to go straight to the source, hiring Nancy-Ann DeParle, the former director of the White House Office of Health Reform.

So now she will be with private equity, and in particular, with a private equity firm specializing in, of course, health care:

Consonance has been out targeting between $350 million and $450 million for its debut fund.

The fundraising effort appears to have gained traction in recent months. LBO Wire reported in February that the firm had raised $30.3 million for Consonance Private Equity PV LP.  According to a person familiar with the fundraising, the vehicle has gathered as much as $200 million so far from investors including Ohio Public Employees Retirement System, Travelers Insurance and LGT Group.

The fund is earmarked for buyouts and recapitalizations of health-care providers, payors, pharmaceutical and specialty distributors and device manufacturers with between $20 million and $150 million in annual revenue.

Finally, it seems Ms DeParle will be suited to this new employment opportunity since she knows so much about how the new supposed health care reform will create investment opportunities,

 Ms. DeParle said the changing regulatory environment will give rise to a host of new investment opportunities. 'There’s a lot that’s changing in health care,' said Ms. DeParle. 'There will be millions of new customers for hospitals and health care providers, much stronger demand for health care services....'

Summary

So to recapitulate, Ms DeParle came from roles as a steward of multiple large health care corporations to lead the health care reform efforts of the executive branch.  In that capacity, she helped to create and enact legislation that she would later say created many "new investment opportunities."  Now, as the legislation is going into operation, she has spun over to private equity to take advantage of these opportunities.

This seems to be a great example of why the revolving door is bad for government, health care, and the American public.  People in responsible government positions, in which they are supposed to represent all the people, may be constantly thinking about impressing those who might employ them in the private sector when they leave government service.  What better way to impress these potential employers than to take actions which may later improve these companies'  commercial prospects, whatever effect they may have on us, the people?

I am no political scientist, but in my humble opinion, there should be multi year cooling off periods before someone who worked in the commercial world can get a job in a government agency whose work has direct effect on his or her previous employer or industry sector, and before someone who worked in a government agency whose work had direct effect on a particular economic sector can accept a job for a company in that sector.  Now that would be a real reform. 

Is the Patient Centered Outcomes Research Institute Really More Industry-Centered?

One of the biggest reasons our health care system seems so dysfunctional is that clinicians and patients have great difficulty determining what might be the appropriate management of particular clinical problems.  Due to endless and sometimes deceptive marketing, conflicts of interest affecting health care professionals and academics, and manipulation and suppression of clinical research, making truly evidence based decisions that put individual patients interests first has become very difficult.  Instead, we may end up using excessively expensive, relatively ineffective, and more dangerous than anticipated drugs, devices, and diagnostic and therapeutic strategies, thus leading to poor patient outcomes and high costs.

Background - the Patient-Centered Outcomes Research Institute (PCORI)

One lingering hope has been that better clinical research, particularly focusing on the outcomes that are most important to patients (patient-centered outcomes), and comparing clinical strategies that may be widely used but poorly evaluated (comparative effectiveness research) would help dissipate the fog.  An attempt to promote such research in the US appeared in our recent health reform legislation, the Affordable Care Act.  It authorized the creation of the Patient Centered Outcomes Research Institute (PCORI).

However, as we observed, how good a solution this would be would depend on the details.  Our concerns were that PCORI, which is an independent although government sponsored institute, not a government agency, might be too beholden to "stake-holders" including the large organizations, device and pharmaceutical companies, insurance companies, hospital systems, etc, that already dominate health care and may promote their and particularly their executives' interests ahead of patients.

Recently, Merrill Goozner, the editor of Modern Healthcare, raised similar concerns,

there is the law's requirement for stakeholder boards to set PCORI research priorities. They must include representatives of researchers, clinicians, patients, providers, insurers, employers and industry. The interests of those groups are not the same. Priority-setting by stakeholder boards could turn into a prescription for steering clear of the most controversial, and therefore most significant, questions.

So,

There is no shortage of drug and device firms, specialty hospitals and medical specialty societies with a vested interest in leaving certain questions unasked or muddying the waters with methodological quibbles. They shouldn't be allowed to hijack or soften the agenda.

PCORI is now in operation, but has seemingly not gotten a lot of scrutiny. What scrutiny it has received as not allayed these concerns.

The PCORI Advisory Panels

Recently, the publication of the membership of four key advisory panels for PCORI got the attention of  Michael Millenson, blogging on the Health Care Blog.  He noted that initially the members of the panels were identified only by name and city of residence, without any information on their other affiliations or characteristics.  He suggested,

PCORI isn’t a church, where all are created equal in the eyes of God, but a politically created, politically governed, controversial dispenser of a very large amount of money that a host of interest groups would like to control. PCORI staff chose the panel members in part by looking at their affiliations, and those connections (or lack of them) should be an immediate part of the public record when the appointments are announced. By being vague, PCORI obfuscates political and power relationships and makes it more difficult for the public and industry stakeholders to either approve of or criticize those choices.

Eventually, PCORI did release somewhat more information on membership of these panels, on Addressing Disparities, Assessment of Prevention, Diagnosis, and Treatment Options, Improving Healthcare Systems, and Patient Engagement.  Mr Millenson was able to review the membership of one panel, and noted some strange anomalies in a comment to his original blog post. 

One panel member who supposedly represents "patients, caregivers, and patient advocates" had a full time position with a pharmaceutical company.  Another worked for a big consumer organization which is heavily funded by the pharmaceutical industry.

This raised concerns that PCORI may get guidance from people whose interests are actually different from those they are supposed to represent.

Therefore, I attempted to review the stated affiliations of all PCORI advisory panels.

Review of the what was made public about the membership of the advisory panels revealed several additional important anomalies.  Members said to be representing "patients, caregivers, and patient advocates" appeared to have positions working for organizations who might have their own, and different interests from the group they were supposed to be representing. 

Let me summarize the apparent anomalies by advisory panel.  In each case, in alphabetical order by panel,  I will list the panelists name, supposed representation, and affiliation, with my comments. 

Addressing Disparities

Monique Carter MS - Dallas, TX
representing: patients, caregivers, and patient advocates
affiliation: Senior Research Scientist, AROG Pharmaceuticals Inc

So this person would appear to be more of an industry (pharmaceuticals) representative.

Venus Gines, MA, P/CHWI - Manvel, TX
representing: patients, caregiver, and patient advocates
affiliation: Instructor, Chronic Disease Prevention and Control Research Center, Department of Medicine, Baylor College of Medicine

So this person appears to be more of a clinician, or health system representative

Doriane C Miller MD - Chicago, IL
representing: patients, caregivers, and patient advocates
affiliation: Director, Center for Community Health and Vitality, University of Chicago Medical Center

So this person also appears to be more of a clinician, or health system representative.

Carmen E Reyes, MA - Whittier, CA
representing: patients, caregivers, and patient advocates
affiliation: Center and Community Relations Manager, Los Angeles Community Academic Partnership in Research in Again, UCLA

So this person appears to be more of a health system representative.

Mary Ann Sander, MHA, MBA, NHA - Pittsuburgh, PA
representing: patients, caregivers, and patient advocates
affiliation: Vice President, Aging  and Disability Services, UPMC Community Provider Services

So this person appears to be more of a health system representative

Deborah Steward, MD, MBA - Jacksonville, FL
representing: clinicians
affiliation: Florida Blue

So in summary, this panel included five people who ostensibly represent patients, caregivers, and patient advocates but who actually work for large academic medical centers or health systems, and one who was there to ostensibly represent patients, caregivers, and patient advocates who works for a pharmaceutical firm.  (In addition, one person supposedly representing clinicians apparently works full time for a health insurance company.)

Assessment of Prevention, Diagnosis, and Treatment Options

Karen Chesbrough, MPH - Annandale, VA
representing: patients, caregivers, and patient advocates
affiliation: Scientific Program Administrator, Foundation for Physical Therapy.

Note that the stated mission of the Foundation for Physical Therapy is that it "supports the physical therapy profession’s research needs," and the foundation is funded in part by companies that make physical therapy devices and supplies  (look here).  Therefore, this person appears to be more of a representative of clinicians, or perhaps industry (devices).

Bettye Green RN - South Bend, IN
representing: patients, caregivers, and patient advocates
affiliation: Community Outreach Nurse and Associate Director of Advocacy, Alliance for Clinical Trials in Oncology, Saint Joseph Regional Medical Center

So this person appears to be more of a health system representative.

Debra Madden - Newtown, CT
representing: patients, caregivers, and patient advocates
affiliation: Clinical Applications Systems Analyst, Associated Neurologists

So this person appears to be more of a clinician representative.

Daniel Wall - Spencer, WI
representing: patients, caregivers, and patient advocates
affiliation: Analyst, Biomedical Informatics Research Center, Marshfield Clinic Foundation

So this person appears to be more of a clinician or health system representative

So in summary, this panel included four people who ostensibly represent patients, caregivers, and patient advocates but who actually work for health systems or clinician organizations, and one of the latter organizations appears to be heavily funded by the medical device and supplies industry.

Improving Healthcare Systems

Susan Diaz MPAS, PA-C - Jacksonville, FL
representing patients, caregivers, and patient advocates
affiliation: Physician Assistant in Liver Transplant, Mayo Clinic in Florida

So this person appears to be more of a clinician, or health system representative.

Anne Sales PhD-  Ann Arbor, MI
representing: patients, caregivers, and patient advocates
affiliation: Professor, School of Nursing, University of Michigan

So this person appears to be more of a clinician, or health system representative.

Jamie Sullivan MPH - Silver Spring, MD
representing: patients, caregivers, and patient advocates
affiliation: Director of Public Policy, COPD Foundation.

Note that the COPD Foundation receives support at least from "Boehringer-Ingelheim/Pfizer Inc. and Grifols" (look here).  .

So this person appears to be at least somewhat an industry (pharmaceutical) representative.

So in summary, this panel includes three people who ostensibly represent patients, caregivers, and patient advocates, two of whom actually work for large health system, and one who works for a foundation with significant pharmaceutical industry support.  

Patient Engagement

Stephen Arcona MA PhD - East Hanover, NJ
representing patients, caregivers, and patient advocates
affiliation: Executive Director, Outcomes Research Methods & Analytics, Department of Health Economics and Outcomes Research, Novartis Pharmaceuticals Corporation

So this person appears to be more of a researcher, and industry (pharmaceutical) representative.

Marc Boutin JD - Washington, DC
representing patients, caregivers, and patient advocates
affiliation: Executive Vice President and Chief Operating Officer, National Health Council 

Note that while the National Health Council claims to be an advocate for people with chronic disease and disability, its core membership includes "major pharmaceutical, medical device, health insurance, and biotechnology companies." and it receives considerable industry support.  For example, it disclosed contributions in the $100,000 - $300,000 range from Amgen, Astra-Zeneca, Eli Lilly, Novartis, Pfizer, and the Pharmaceutical Research and Manufacturers of America (PhRMA), and smaller but still significant contributions from other pharmaceutical companies and other industry associations.  So this person appears to be at least somewhat of an industry (pharmaceutical) representative.

Charlotte W Collins JD - Elkridge, MD
representing patients, caregivers, and patient adovcates
affiliation: Vice President of Policy and Programs, Asthma and Allergy Foundation of America

Note that while the Asthma and Allergy Foundation of America claims to be a patient advocacy organization, it disclosed financial support from many pharmaceutical, device, and health insurance companies, and from major health care systems

So this person appears to be at least somewhat an industry, health insurance, and/or health system representative.

Amy Gibson, RN MS - Washington, DC
representing patients, caregivers, and patient advocates
affiliation: Chief Operating Officer, Patient-Centered Primary Care Collaborative (PCPCC)

Note that the PCPCC has an executive committee that includes multiple pharmaceutical, device, and health insurance companies, and health systems.  So this person appears to be at least somewhat an industry, health insurance, and/or health system representative.

Julie Ginn Moretz - Augusta, GA
representing patients, caregivers, and patient advocates
affiliation: Associate Vice Chancellor, Patient- and Family-Centered Care, University of Arkansas for Medical Sciences

So this person appears to be more of health system representative.

Sara Triagle van Geertruyden - Washington, DC
representing patients, caregivers, and patient advocates
affiliation: Executive Director, Partnership to Improve Patient Care (PIPC)
(Note: this affiliation appears incomplete.  Sara van Geertruyden is listed as a current partner of Thorn Run Partners, a lobbying firm, with a major practice area in health care, boasting, "Thorn Run Partners offers one of Washington, DC’s most comprehensive, competent and effective health policy practices."


Note also that PIPC has membership that includes many specialty physician societies, and a steering committee that includes the Biotechnology Industry Organization, and PhRMA. 

So this person appears to be more of an industry (pharmaceutical and biotechnology) representative.

So in summary this panel includes six members who ostensibly represent patients, caregivers, and patient advocates, but who work for either patient advocacy organizations that get considerable industry support, or a health system, or a pharmaceutical company.  One person whose affiliation was listed as a patient advocacy organization also somehow appears to be a full-time lobbyist.  

Summary

While PCORI has set up advisory panels that seem to strongly emphasize representation of patients, caregivers, and patient advocates, a substantial fraction of the people who are supposed to provide this representation seem to work for patient advocacy groups with considerable industry support, or directly for industry or health care systems.  Some of them may work as clinicians or researchers, but many appear to have high level executive positions with these organizations.  One appears to be a full-time lobbyist at a firm that has a strong health care practice. 

Thus it appears that PCORI advisory panels actually may be as much about the interests of big health care organizations, including pharmaceutical and device companies, health insurance companies, and large hospital systems, as they are about patients, caregivers, or patient advocates.  

I am afraid my and Merrill Goozner's original fears that PCORI may end up being more about industry-centered interests than patient-centered outcomes may not be paranoid.  I do hope that PCORI leadership manages to put improving patients' and the public's health ahead of making industry executives happy. 

by Roy M. Poses MD, for Health Care Renewal