Ho-hum, Another Month, Another Set of Multi-Million Dollar Settlements by Health Care Corporations Acting Badly

adverse effects deception Fresenius health care prices impunity legal settlements Merck Pfizer Vioxx You heard it here first

Ho-hum, Another Month, Another Set of Multi-Million Dollar Settlements by Health Care Corporations Acting Badly

Unknown 2/21/2016 Komentar

Amazingly, with a US presidential election looming, there is finally some public discussion here of the impunity of top corporate executives.  Columnist Gretcher Moregenson wrote on February 6, 2016 in the New York Times,

Ho-hum, another week, another multimillion-dollar settlement between regulators and a behemoth bank acting badly.

Then,

As has become all too common in these cases, not one individual was identified as being responsible for the activities. Once again, shareholders are shouldering the costs of unethical behavior they had nothing to do with.

It could not be clearer: Years of tighter rules from legislators and bank regulators have done nothing to fix the toxic, me-first cultures that afflict big financial firms.

Similarly, but more broadly, Senator Elizabeth Warren (D - Massachusetts) published a report in January, 2016, entitled "Rigged Justice: 2016 - How Weak Enforcement Lets Corporate Offenders Off Easy." She summarized its main conclusions in a New York Times op-ed,

Corporate criminals routinely escape meaningful prosecution for their misconduct.

Furthermore,

In a single year, in case after case, across many sectors of the economy, federal agencies caught big companies breaking the law — defrauding taxpayers, covering up deadly safety problems, even precipitating the financial collapse in 2008 — and let them off the hook with barely a slap on the wrist. Often, companies paid meager fines, which some will try to write off as a tax deduction.

The failure to adequately punish big corporations or their executives when they break the law undermines the foundations of this great country. Justice cannot mean a prison sentence for a teenager who steals a car, but nothing more than a sideways glance at a C.E.O. who quietly engineers the theft of billions of dollars.

These enforcement failures demean our principles. They also represent missed opportunities to address some of the nation’s most pressing challenges.

In particular, she cited this example involving health care.

When Novartis, a major drug company that was already effectively on federal probation for misconduct, paid kickbacks to pharmacies to push certain drugs, it cost taxpayers hundreds of millions of dollars and undermined patient health. Under the law, the government can boot companies that defraud Medicare and Medicaid out of those programs, but when Novartis got caught, it just paid a penalty — one so laughably small that its C.E.O. said afterward that it 'remains to be seen' whether his company would actually consider changing its behavior.

Note that we discussed the Novartis settlement here.  The case referred to by Senator Warren was just the latest in a series of ethical misadventures by Novartis which led to legal actions in the US and around the world, but feeble penalties.

But while Ms Morgenson wrote about financial institutions, now we can also write:

Ho-hum, another month, another set of multimillion-dollar settlements between regulators and  behemoth health care companies acting badly.

In chronological order, since mid-January, 2016...

For $830 Million, Merck Settled Shareholders Lawsuit Alleging Deceptions by Corporate Management

On January 15, 2016, the Wall Street Journal reported,

Merck said Friday it agreed to pay $830 million to resolve a class-action lawsuit brought by shareholders, alleging the drug maker and its executives made false and misleading statements about the safety of Vioxx between its introduction in 1999 and its market withdrawal in 2004.

The shareholders alleged they paid inflated prices for Merck shares because of the company’s conduct.

Note that if the company misled its shareholders, it also misled health care professionals and the public about the harms of Vioxx,  putting many patients at risk. Of course, the Vioxx case is now old news, but it continues to be an example of a case in which the corporation paid fines, presumably at the expense of shareholders, employees and patients, but in which no one who authorized or directed the bad behavior paid any penalty.

As is typical in such cases,

Merck, which is based in Kenilworth, N.J., said Friday the settlement of the shareholders’ lawsuit doesn’t constitute an admission of liability or wrongdoing by the company or individual executives named as defendants in the case.

Merck has paid billions to settle multiple lawsuits related to Vioxx, yet what it paid was much less than the revenue produced by the drug.

The bulk of Merck’s Vioxx-related costs came from its 2007 agreement to pay $4.85 billion to settle thousands of product-liability lawsuits alleging that patients’ use of Vioxx caused heart attacks and strokes, and that Merck failed to properly warn people of the risks. Merck didn’t admit liability in that settlement.

In addition, Merck agreed in 2011 to pay $950 million to resolve allegations by the U.S. Justice Department and state governments that the company deceived the government about the safety of Vioxx, and marketed it for uses not included in the prescribing label approved by the Food and Drug Administration.

Merck recorded more than $11 billion in Vioxx sales during the drug’s years on the market from mid-1999 to September 2004.

The company did plead guilty to one criminal charge related to Vioxx.

 As part of the 2011 settlement, Merck pleaded guilty to a misdemeanor criminal violation of a federal drug law, admitting that it promoted Vioxx to treat rheumatoid arthritis before that use was approved by the FDA.

But apparently no Merck manager was ever charged with a crime, much less convicted.  We have discussed the Vioxx case here, and other issues with Merck here.

Note that this settlement comes soon after a smaller settlement in 2015 that was barely mentioned in the press,Merck to pay $5.9 million for misleading marketing of pink eye drug: U.S [Reuters]

For $785 Million, Pfizer Settled Suit Alleging Overcharging of Medicaid

On February 16, 2016, per the Wall Street Journal,

Drugmaker Pfizer Inc. on Tuesday said it reached an agreement in principle to pay $784.6 million to settle a long-running U.S. government investigation of allegations that its Wyeth unit overcharged government Medicaid health programs for the heartburn drug Protonix.

Of course,

Pfizer said the agreement doesn’t include any admission of liability by Wyeth.

Much less did the agreement include any penalties for anyone at Wyeth or Pfizer who authorized or directed the overcharging. Yet some people must have.

Note that this settlement did not seem informed by Pfizer's amazingly lengthy record of legal settlements, and some guilty pleas and/or convictions (for illegal marketing/ misbranding, and for violating the racketeering influenced corrupt organization [RICO]  statute), as most recently summarized here.

Note also, pertinent to the report by Senator Warren mentioned above, every week people pay severe penalties for defrauding Medicaid, Medicare, or other federal health programs.  Today, a quick Google search for "medicaid fraud prison" found such stories from the last month as a woman sentenced to five years in Louisville, and another women sentenced again to five years in Dallas. Yet no person at Pfizer paid any penalty for for practices that deprived the government of hundreds of millions of dollars.  

For $250 Million, Fresenius Settled Lawsuits Alleging it Withheld Information About the its Products' Hazards

Per the New York Times, January 18, 2016,

The world’s largest provider of kidney dialysis equipment and services has agreed to pay $250 million to settle thousands of lawsuits from dialysis patients and their relatives claiming that the company’s products had caused heart problems and deaths.

The settlement was announced by Fresenius Medical Care, a German company whose North American division is one of the two large dialysis providers in the United States.

The lawsuits arose after Fresenius’s own medical office sent an internal memo to doctors in the company’s dialysis centers saying that failure to properly use one of the company’s products appeared to be causing a sharp increase in sudden deaths from cardiac arrest.

But the company did not warn doctors in non-Fresenius clinics who were also using the product, called GranuFlo. It did so only after the internal memo was sent anonymously to the Food and Drug Administration, which began an investigation.

 The company conducted a recall, which was actually a change in the label, not the removal of the product from the market.

Note that this settlement was of allegations not of financial chicanery, but of behavior that put patients in harms way. Nonetheless,

Kent Jarrell, a spokesman for the company, said the initial internal memo was actually incorrect and contradicted by further careful analysis. He said the warning language added to the GranuFlo label in 2012 was eventually removed. GranuFlo, and a related product called NaturaLyte, are used in dialysis machines to help cleanse patients’ blood.

In the first case to go to trial, a jury in Massachusetts state court ruled that Fresenius was negligent, for not distributing the memo more widely, but that a patient’s death could not be attributed to GranuFlo, so no monetary damages were awarded, according to Mr. Jarrell and to Christopher Seeger, a lawyer who led the settlement negotiations for the plaintiffs.

But if the initial concern was unwarranted and Fresenius won the first trial, why would it pay $250 million to settle? Mr. Jarrell suggested that a reason was to put the more than 10,000 lawsuits behind it.

'Fresenius deeply regrets the confusion and concern temporarily generated by the November 2011 memorandum,' he said in an emailed statement.

Again, there were no admissions or findings of guilt, no apologies (except for causing "confusion and concern"), and no negative consequences for the corporate managers who authorized or directed the actions in question.  While the FDA apparently issued a recall notice for GranuFlo, no federal agency apparently took action against the company or any individuals within it.    Also, this settlement seemed uninformed by previous settlements made by Fresenius, which were made in 2011 of allegations of false claims, in 2010 again of allegations of false claims, and in 2007 of allegations of restraint of trade (look here).

Summary

We first discussed how legal settlements may serve as markers for misbehavior by large health care organizations, but not as deterrents to future bad behavior in 2006.  Then we wrote ...

 Why do the mainly monetary penalties seem mainly to come out of the hides of stock-holders and consumers, rather than the people who actually made the decisions that lead to the offenses?

In 2008, we wrote,

After all, a fine or settlement paid years later can just be written off as a cost of doing business. Furthermore, although such a payment may have a (minimal) effect on the company's bottom line, it has no real effect on the people whose decisions and actions lead to the problem.

So rather than repeating our usual verbiage about the impunity of health care leaders, let me defer to Senator Warren:

Laws are effective only to the extent they are enforced. A law on the books has little impact if prosecution is highly unlikely.

This country devotes substantial resources to the prosecution of crimes such as murder, assault, kidnapping, burglary and theft, both in an effort to deter future criminal activity and to provide victims with some degree of justice. Strong enforcement of corporate criminal laws serves similar goals: to deter future criminal activity by making would-be lawbreakers think twice before breaking the law and, sometimes, by helping victims recover from their injuries.

When government regulators and prosecutors fail to pursue big corporations or their executives who violate the law, or when the government lets them off with a slap on the wrist, corporate criminals have free rein to operate outside the law. They can game the system, cheat families, rip off taxpayers, and even take actions that result in the death of innocent victims—all with no serious consequences.

The failure to punish big corporations or their executives when they break the law undermines the foundations of this great country: If justice means a prison sentence for a teenager who steals a car, but it means nothing more than a sideways glance at a CEO who quietly engineers the theft of billions of dollars, then the promise of equal justice under the law has turned into a lie. The failure to prosecute big, visible crimes has a corrosive effect on the fabric of democracy and our shared belief that we are all equal in the eyes of the law.

Under the current approach to enforcement, corporate criminals routinely escape meaningful prosecution for their misconduct. This is so despite the fact that the law is unambiguous: if a corporation has violated the law, individuals within the corporation must also have violated the law. If the corporation is subject to charges of wrongdoing, so are those in the corporation who planned, authorized or took the actions. But even in cases of flagrant corporate law breaking, federal law enforcement agencies – and particularly the Department of Justice (DOJ) – rarely seek prosecution of individuals. In fact, federal agencies rarely pursue convictions of either large corporations or their executives in a court of law. Instead, they agree to criminal and civil settlements with corporations that rarely require any admission of wrongdoing and they let the executives go free without any individual accountability.

Keep in mind that the impunity of health care leaders, especially in contrast with the tough enforcement efforts against small fry health care offenders, not only has a corrosive effect on the fabric of democracy but endangers patients' and the public's health, and makes health care more expensive and inaccessible.

Maybe now that the impunity of corporate leaders is becoming a mainstream topic of discussion, we can start talking about, and then doing something about the impunity of corporate leaders in health care. 

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Academic Medical Leaders as Directors of For-Profit Health Care Corporations: the Prevalence of This "New Species" of Conflict of Interest Documented in the BMJ

academic medical centers boards of directors conflicts of interest institutional conflicts of interest medical schools You heard it here first

Academic Medical Leaders as Directors of For-Profit Health Care Corporations: the Prevalence of This "New Species" of Conflict of Interest Documented in the BMJ

Unknown 10/01/2015 Komentar

The important conflicts of interest generated when academic health care leaders also serve on the boards of directors of for-profit health care corporations is suddenly less anechoic, thanks to some intrepid researchers and the British Journal of Medicine.

Background: Academic Health Care Leaders Also Serving as Directors of For-Profit Health Care Corporations

First Discovered Cases

In 2006, we first noticed that leaders of academic medicine also were serving as board members of large for-profit health care corporations.  The first example we discussed was that of Marye Anne Fox, Chancellor (equivalent to president) of the University of California - San Diego, and hence the person to whom the University of California, San Diego School of Medicine and its academic medical center report. The conflict was between this position, and her service as a member of the board of directors of Boston Scientific, a medical device manufacture, and the board of directors of Pharmaceutical Product Development Inc., a contract research organization.

Later that year, we discussed a "new species of conflict of interest."  At that time we wrote:

Medical schools and their academic medical centers and teaching hospitals must deal with all sorts of health care companies, drug and device manufacturers, information technology venders, managed care organizations and health insurers, etc, in the course of fulfilling their patient care, teaching, and research missions. Thus, it seems that service on the board of directors of a such public for-profit health care company would generate a severe conflict for an academic health care leader, because such service entails a fiduciary duty to uphold the interests of the company and its stockholders. Such a duty ought on its face to have a much more important effect on thinking and decision making than receiving a gift, or even being paid for research or consulting services. Furthermore, the financial rewards for service on a company board, which usually include directors' fees and stock options, are comparable to the most highly paid consulting positions. What supports the interests of the company, however, may not always be good for the medical school, academic medical center or teaching hospital.

Since 2006, we continued to find colorful examples of such conflicts of interest, e.g.,

- In 2006, the UnitedHealth board included multiple academic leaders, at least one of whom seemed partly responsible as a member of the board compensation committee for allowing the then UnitedHealth CEO to collect many backdated stock options (look here)
- In 2009, some attributed the problems at George Washington University's medical school that caused it to be put on probation to the conflict of interest of its provost and vice president for health affairs,  who also sat on the board of Universal Health Services, which owned the university hospital (look here)...

Through more recent years,

- In 2014, members of the AMA committee that has an outsize role in how the government fixes the pay of US doctors wer also found to be members of boards of directors of such companies as Kindred Healthcare, Hanger Inc, and Sante. (Look here.)
- In 2015, the academic physician and research unit leader nominated to be the new head of the US Food and Drug was a director of Portola Pharmaceuticals (look here)...

Look here for even more

Our Early Cross-Sectional Study

In 2007, we did a somewhat rough and ready research project based on 2005 data to determine the prevalence of such conflicts.  The results were presented in abstract form,(1) but not published as an article:

In 2005, there were 164 US health care companies in the 2005 S&P 1500, and 125 US medical schools. We identified 198 people who served on the companies' boards of directors who had faculty or leadership positions at these medical schools. Of the 125 medical schools, 65 schools had at least one faculty member and/or leader who also served on a health care corporation's board of directors. 15 schools had more than five, and 4 had more than 10 such individuals. Of the 125 schools, 7 reported to university presidents who were also directors of health care corporations, and 11 schools reported to vice-presidents for health affairs who were also such corporate directors. Four schools were lead by deans who were also health care corporate directors, and 10 schools had academic medical center CEOs who were such directors. 22 schools had at least one top leader who was also a director of a health care corporation. 36 schools reported to university boards of trustees which each included at least one director of a health care corporation, and 12 schools' own boards of trustees included at least one such director.

We concluded:

more than one-half of US medical schools had a leader or faculty member who also was a director of a major US for-profit publicly traded Bpure^ health care corporation, more than one-sixth of schools had a top leader who was also such a director, and more than one-fifth reported to boards of trustees which included such directors.

More Modern and Complete Data

Unfortunately, we never wrote a full paper about this work, although the likelihood we could have gotten it published around 2007 was very small.  It is fortunate that Anderson and colleagues did a more complete and current version of this project, which was published online this week by the British Medical Journal.(2)

Methods

Their methodology was similar to our earlier work, but more sophisticated.  They obtained data on the 2013 board members of 446 public for-profit US companies listed on New York Stock Exchange or NASDAQ and classified as in the healthcare sector, including pharmaceutical, biotechnology, medical equipment and supply companies and health care providers from the companies' 2014 proxy statements.

Results

Their results were striking, suggesting even a greater prevalence of conflicted academic leaders than our preliminary results suggested

Directors were affiliated with 85 geographically diverse non-profit academic institutions, including 19 of the top 20 National Institute of Health funded medical schools and all of the 17 US News honor roll hospitals. Overall, these 279 academically affiliated directors included 73 leaders, 121 professors, and 85 trustees. Leaders included 17 chief executive officers and 11 vice presidents or executive officers of health systems and hospitals; 15 university presidents, provosts, and chancellors; and eight medical school deans or presidents.

The new study also described the direct financial relationships among the academic leaders, professors and trustees and the corporations on whose boards they served.

The total annual compensation to academically affiliated directors for their services to companies was $54 995 786 (£35 836 000; €49 185 900) (median individual compensation $193 000) and directors beneficially owned 59 831 477 shares of company stock (median 50 699 shares).

Discussion

As we have suggested, Anderson et al stated that being on the board of directors of a for-profit health care corporation creates conflicts of interest beyond those created by simply having a financial relationship with a health care company, e.g., by participating in a commercially sponsored research project or acting as a consultant to a company.

Similar to individuals engaging in consulting relationships, directors on industry boards enter a formal contract with the company and receive financial payment for services; however, they are subject to two important differences. Firstly, unlike consultants who are compensated to provide expertise on a specific issue, directors are subject to a fiduciary responsibility to company shareholders to advance the general interests of the company and increase profits. Secondly, directors are reimbursed both through larger cash fees than typical consulting contracts and through stock options, the value of which is directly tied to the financial success of the company.

They also added the reminder that,

Though the missions of academia and for profit companies can overlap, they may also diverge, specifically when the for profit mission of industry competes with the non-profit taxpayer funded clinical and research missions of academic medical and research institutions.

So,

previous guidelines have emphasized the relationships of clinicians and researchers with industry, but institutional conflicts of interest, which arise when administrators, including executive officers, trustees, and clinical leaders have a financial relationship with industry, are increasingly recognized and pose a unique set of risks to academic missions. 

Our Summary

We have written again and again on the problem of conflicts of interest affecting health care professionals, academics, and policy makers.  The worst such conflicts may occur when individuals are simultaneously leaders of large mission-oriented health care non-profit organizations, such as teaching hospitals, medical schools, or research institutes, and board members of for-profit health care corporations.  Despite our attempts to raise such issues as important, and probably important causes of health care dysfunction, they have remained anechoic.

Now a broadly based study of this no longer so "new species" of conflict of interest has appeared in one of the biggest and most prestigious medical journals.  Let us hope it will bring this issue to the forefront, and also partially counter those who have been preaching that concerns about conflicts of interest in health care are overblown.

As we have said again and again, the web of conflicts of interest that is pervasive in medicine and health care is now threatening to strangle medicine and health care.  Furthermore, this web is now strong enough to have effectively transformed US health care into an oligarchy or plutocracy.  Health care is effectively run by a relatively small group of people, mainly professional managers plus a few (lapsed?) health care professionals, who simultaneously run or influence multiple corporations and organizations.

For patients and the public to trust health care professionals and health care organizations, they need to know that these individuals and organizations are putting patients' and the public's health ahead of private gain. Health care professionals who care for patients, those who teach about medicine and health care, clinical researchers, and those who make medical and health care policy should do so free from conflicts of interest that might inhibit their abilities to put patients and the public's health first.

Health care professionals ought to make it their highest priority to ensure that the organizations for which they work, or with which they interact also put patients' and the public's health ahead of private gain, especially the private gain of the organizations' leaders and their cronies.

ADDENDUM (16 November, 2015) - Note that an abbreviated version of this post has appeared as an electronic "rapid response" to the article by Anderson et al (link here), although the published form has on it our original submission date.   

References

1. Poses RM, Smith WR, Crausman R, Maulitz R. Selling them the rope: prevalence of for-profit health care corporate dirctors among academic medical leaders. J Gen Intern Med 2007; 22 (Suppl 1): 98.
2.  Anderson TS, Good CB, Gellad WF.  Prevalence and compensation of academic leaders, professors and trustees on publicly trade US healthcare company boards of directors: cross sectional study.  Brit Med J 2015; 351:h4826.  Link here. 

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How Institutional Conflicts of Interest Exacerbate the Anechoic Effect - the Example of ASCO Fearing "Biting the Hand that Feeds You"

American Society of Clinical Oncology anechoic effect conflicts of interest health care prices institutional conflicts of interest medical societies You heard it here first

How Institutional Conflicts of Interest Exacerbate the Anechoic Effect - the Example of ASCO Fearing "Biting the Hand that Feeds You"

Unknown 6/27/2015 Komentar

As we recently discussed (here, here, here and here), in May, 2015, the New England Journal of Medicine, arguably the world's foremost medical journal, published an editorial and a three-part commentary arguing that current concerns about the effects of financial conflicts of interest (COI) on health care are overblown(1-4).  On June 1, the Wall Street Journal published a report on the 2015 meeting of the American Society of Clinical Oncology (ASCO) that provided a vivid example of why these concerns should not be dismissed.

Questioning Drug Prices at the ASCO Meeting

The main issue in the article was:

In a sign of growing frustration with rising drug prices, a prominent cancer specialist on Sunday sharply criticized the costs of new cancer treatments in a high-profile speech at one of the largest annual medical meetings in the U.S.

'These drugs cost too much,' Leonard Saltz, chief of gastrointestinal oncology at Memorial Sloan Kettering Cancer Center, said in a speech heard by thousands of doctors here for the annual meeting of the American Society of Clinical Oncology.

The notion that health care prices are high and are rising continuously in the US should hardly be novel for regular Health Care Renewal readers.  We have been writing about it for a while, starting in 2005.

We first posted about high drug prices in July, 2005, with the example of BilDil.  This was a brand-name combination drug that included two compounds that were already cheaply available in generic form, advertised as a uniquely convenient therapy for congestive heart failure.  We were aghast that the price of the combination drug might be $5.40 - $10.80 a day (in 2005 dollars), over three times the cost of the two drugs in generic form.

But only a few days later we noted that three cancer costs had yearly costs in the five figures, and one, Erbitux, cost as much as $100,000.  Most amazingly we noted that Thalidomid was priced at $25,000  a year.  Yet it was just the infamous thalidomide, the drug initially marketed as a tranquilizer that caused severe birth defects after it was initially sold in Europe.  The drug was still available in generic form in South America for about seven cents a pill.

Since then, the ridiculously high prices of many tests and treatments, but most notably new drugs and devices, has been so widely covered our discussion has been limited to special cases.   For example, consider just a few headlines from April to May, 2015.

How Much Would You Pay for an Old Drug? If You Have MS, a Fortune (Bloomberg)

Pharmaceutical Companies Buy Rivals' Drugs, Then Jack Up the Prices (WSJ)

How Marketing Exclusivity Led to Higher Drug Costs and Questionable Benefits (WSJ)

Runaway Drug Prices (NY Times)


Drug Prices as a Taboo Topic

However, despite this wide attention to the problem, the speech at ASCO was notable.  Back to the WSJ...

Dr. Saltz’s speech was unusual because it was made at the meeting’s plenary session, where the field’s most significant scientific research is presented and which all meeting participants are expected to attend. An estimated 25,000 doctors and scientists attended this year’s meeting.

One would think that the high price of drugs, especially cancer drugs, would be a fit subject for discussion at a plenary session of ASCO, however,

It is unprecedented for plenary speeches, which typically address scientific and medical issues, to substantially take on the topic of drug costs, said Alan Venook, a professor of medicine at the University of California San Francisco who planned the meeting’s scientific session and invited Dr. Saltz to speak.

The prominent venue for the speech was also unusual because, like many medical meetings, ASCO is sponsored by pharmaceutical companies and often focuses on highlighting advancements in drug development, said Dr. Venook. He said discussing drug prices there is 'uncomfortable' because it could be seen as 'biting the hand that feeds you.'

Doctors are also reluctant to antagonize the drug industry because they need pharmaceutical firms to invest in developing new medicines for patients, he said.

'It’s a tough balancing act for ASCO where the meeting is largely funded by pharma,' Dr. Venook said in an interview. 'You can’t have a [plenary] talk trashing pharma, but you can have a talk by a respected person questioning it.'

So because pharma gives ASCO a lot of money, at best, only the most distinguished ASCO members can gently question pharma, but cannot criticize, much less "trash" the source of their mammon.


This is thus a succinct example of why financial conflicts of interest in medicine and health care can be bad.  The incredibly high prices of cancer drugs should be a fit topic for discussion at a meeting run by a society of medical oncologists.  But those in charge of the meeting and the society are afraid to initiate such a discussion, and even more afraid of appearing to criticize the companies that charge these prices, because the society has become dependent on money from these very same companies.  So this is further an example of how conflicts of interest can create the anechoic effect - the notion that certain topics in medicine and health care are taboo, because discussing them might trouble the powers that be, and particularly the moneyed interests that now dominate medicine and health care. 

In a succinct response to the NEJM series (1-4) soft pedaling concerns about conflicts of interest, the British Medical Journal ran a commentary by a former NEJM national correspondent, and two former NEJM editors.(5)  It stated,

The NEJM has now sought to reinterpret and downplay the importance of conflicts of interest in medicine by publishing articles that show little understanding of the meaning of the term. The concern is not whether physicians and researchers who receive industry money have been bought by the drug companies, as Drazen writes, or whether members of guideline panels or advisory committees to the US Food and Drug Administration with ties to industry make recommendations that are motivated by a desire for financial gain, as Rosenbaum writes. The essential issue is that it is impossible for editors and readers to know one way or the other.

In this case, we seem not to be talking about the possibility that health care professionals "have been bought by the drug companies,"  but how drug companies essentially "buying" a professional organization has apparently heretofore prevented medical professionals from discussing a vital issue that could have major effects on patients.

Following the Money

In case there is any question about the money involved and its sources, one only needs to go to some publicly available in formation supplied by ASCO (mostly because of reporting requirements imposed on all US non-profit organizations of a certain size).  

The latest (2014) annual report from ASCO reveals that the organization only gets 16.1% of its revenue from member dues.  Thus a ostensible membership organization gets only about a sixth of its funding from members' dues.

Yet the organization has become quite wealthy.  Its most recent (2013) US Internal Revenue Service 990 Form reveals that it owns over $55 million in real estate, and has over $104 million in investments (presumably as an endowment.)  The organizations' leaders are also doing very well. Its CEO, Allen Lichter MD, got $804,775 in total compensation in 2012.  Eleven other managers, of which three are health care professionals (one MD, one RN, one PharmD), got at least $220,000 in total compensation.  Five of them got more than $300,000. 

The source of all that money seems mainly to be pharmaceutical and other health care corporations that sell goods and services for cancer care.  US non-profit organizations are not forced by law to reveal the details of their financial support.  However, the ASCO annual report does list 23 pharmaceutical and biotechnology companies, and one for-profit cancer hospital chain as contributing at least $1 million each in total to the non-profit over time.  The report lists 37 pharmaceutical, biotechnology, and medical device companies as current corporate donors, and also 10 other for-profit health care related corporations as current corporate donors.

In addition to these apparently marked institutional conflicts of interest, ASCO leaders may have their own individual conflicts of interest.  I do not have the resources to search all relationships affecting meeting organizers and ASCO officers and trustees, and the organization does not post conflicts of interest affecting its leadership and governance in a prominent place. However, Dr Alan Venook, who confessed to his discomfort about inviting a talk that might be perceived as biting the hand that feeds the finances of ASCO, is or has been on advisory boards for Thershold Pharmaceuticals,  Mirna Therapeutics, and GlobeImmune.  For a 2014 presentation, he gave the following disclosures: "Research support from Genentech/Roche, BMS, Lilly, Novartis; H. Lenz: Consulting, advisory boards and research support from Genentech/Roche, BMS and Merck."  Furthermore, the current chair of the ASCO Board of Directors, Julie M Vose, MD, is also on the Medical Advisory Board of EmergingMed Inc, and the Clinical Advisory Board of Bullet Biotechnology.

Summary

The New England Journal of Medicine recently launched a counter-attack against the "pharmascolds" who are allegedly slowing the pace of medical progress by their excessive and puritanical concerns about financial conflicts of interest.  Yet the arguments that COIs could be bad for health care are logical, and based on at least some reasonably good evidence.  (See the article by Steinbrook et al in the BMJ mentioned above[4], the accompanying BMJ editorial[5] just to start and then the 2009 Institute of Medicine report.)

Moreover, we have encountered a lot of vivid cases suggesting that conflicts of interest can have adverse influences on health care.  In this most recent one, we see at least one prominent if conflicted organizational insider admitting that institutional, and perhaps individual conflicts of interest have made discussion of at least one big health care and health care policy topic taboo.  This seems to corroborate our previous discussion that the anechoic effect - that certain topics in health care are taboo - may be generated by conflicts of interest of the people who ought to discuss them, or of those to whom those people may have to answer.

True health care reform requires full disclosure of conflicts of interest for honesty's sake, and marked reduction of conflicts affecting those who make health care decisions on behalf of individual patients, and health care policy decisions that affect patients' and the public's health.  If we allow conflicts of interest to continue, we will have difficulty even discussing the most severe problems affecting health care, because those generating the topics are benefiting from the circumstances that enable such problems.

ADDENDUM (1 July, 2015) - This post was republished on 28 June, 2015, on the Naked Capitalism blog. 

ADDENDUM (20 July, 2015 ) - This post was republished on July 12, 2015 in OpenHealth News.

References

  1.Drazen JM.  Revisiting the commercial-academic interface.  N Eng J Med 2015; ; 372:1853-1854. Link here.
2. Rosenbaum L.  Reconnecting the dots - reinterpreting industry-physician relations.  N Eng J Med 2015; 372:1860-1864.  Link here.
3. Rosenbaum L. Understanding bias - the case for careful study.  N Engl J Med 2015;  372:1959-1963.  Link here.
4.  Rosenbaum L.  Beyond moral outrage - weighing the trade-offs of COI regulation. N Engl J Med 2015; 372: 2064-2068.  Link here.
5. Steinbrook R, Kassirer JP, Angell M.  Justifying conflicts of interest in medical journals: a very bad idea.  Brit Med J 2015; 350: h2942.  Link here. 
6. Loder E. Revisiting the commercial-academic interface in medical journals.  Brit Med J 2015; 350: h2957.  Link here.

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More Barbarians at the Gates: Private Equity Puts Primary Care in Play

corporate physician primary care private equity You heard it here first

More Barbarians at the Gates: Private Equity Puts Primary Care in Play

Unknown 4/26/2015 Komentar

There are still some idealistic physicians who enter primary care practice as a calling.

The usual informal definition of primary care is care which is continuous, coordinated, comprehensive and compassionate.  The official definition used by the American Academy of Family Physicians (AAFP) is:

Primary care is that care provided by physicians specifically trained for and skilled in comprehensive first contact and continuing care for persons with any undiagnosed sign, symptom, or health concern (the 'undifferentiated' patient) not limited by problem origin (biological, behavioral, or social), organ system, or diagnosis.

Primary care includes health promotion, disease prevention, health maintenance, counseling, patient education, diagnosis and treatment of acute and chronic illnesses in a variety of health care settings (e.g., office, inpatient, critical care, long-term care, home care, day care, etc.). Primary care is performed and managed by a personal physician often collaborating with other health professionals, and utilizing consultation or referral as appropriate.Primary care provides patient advocacy in the health care system to accomplish cost-effective care by coordination of health care services. Primary care promotes effective communication with patients and encourages the role of the patient as a partner in health care.

Private Equity Firms are Buying Out Primary Care Practices

However, an article this week in Modern Healthcare described how primary care in the US is getting a rude surprise.  Apparently, primary care practices are now "in play," (using the terminology for the classic 1987 movie Wall Street, in which Gordon Gekko declared that greed is good).



The argument was that there is

a small but growing number of investments that private-equity firms are making in primary-care physician practices that are ahead of the curve in offering new care delivery and payment models. Investors see an opportunity in being early participants in value-based care, even as the business case is still unclear given mixed results in Medicare's payment and delivery reform demonstrations so far.

But the niche is well-suited for private-equity firms, which feed on uncertainty, said Todd Spaanstra, a partner at Crowe Horwath, an accounting and consulting firm. 

This is not about quality of care, it is about the idea that business people think that "value-based care" and "risk-based contracting" are the current rages, and so there is money to be made investing in entities that seem to fit in with these fashions.

said Slava Girzhel, managing director at KeyBanc Capital Markets. 'There's a lot of discussion about private-equity investing in risk-based models, and I do think we'll see more of that.'

Continuous, coordinated, comprehensive and compassionate care may suffer when the time horizons are not that long, and the owners of the practice are ultimately looking to sell it. 

The long-term opportunity for private-equity firms is the ability to sell these managed-care-savvy medical groups to insurers or health systems, which may pay a premium for the care-coordination expertise and data analytics these practices offer.

Also,

The typical private-equity investment timetable is short—about five years. At that point, the firm would probably look to sell the practice, ideally to an insurance company or a health system, said Dan Hosler, a principal at private-equity firm Sterling Partners.

Furthermore, why private equity may be interested in primary care now, continuing interest will depend on the numbers, not on the benefits to patients

'This is an area where there are winners and losers,' said Dr. Andrei Gonzales, director for value-based reimbursement initiatives at McKesson Health Solutions. 'It's everyone trying to get a slice of the pie that's getting smaller.'

What Happens When the Barbarians are at the Gate

Conspicuously absent from this article was discussion of aspects of the private equity modus operandi which are even more at odds with primary care values than the short time horizon noted above.  We previously warned about the perils of private equity employing physicians (look here.)  The main points were:

-  Private equity is just the new name for leveraged buyout firms (the type of firm described the book, Barbarians at the Gate.)

-  Therefore, when they buy out firms (e.g., the primary care practices discussed above), they use borrowed money.

-  But they leverage in two senses.  Once firms are bought, the private equity owners makes the firms take out further loans, and the money from them may go back to the owners, usually in the form of a special dividend, to pay down the debt originally incurred by the private equity owners.  This leaves the bought out firms heavily in debt, but frees the private equity firm from its original debt.  If the firm is eventually sold, the new buyers take over the debt.  In a worst case scenario, however, the bought out firm goes bankrupt, the private equity's firm stock in it becomes worthless, but the private equity firm need not be responsible for its financial obligations.

-  If the private equity firm desires more money while it still owns the acquired firm, it may sell parts of it off.

-  To make the finances of the acquired firm look more attractive to the next buyer, the private equity firms often undertakes short term cost cutting measures that may involve layoffs, increased workload on remaining workers, etc.

Other dark aspects of private equity are discussed on the Naked Capitalism blog here.

Summary

Primary care physicians thinking about selling their practices to private equity ought to think at least twice before doing so, assuming the physicians are serious about upholding the values of primary care.  Private equity firms are in it for the money, and in the relatively short term.  Private equity firms are unlikely to care about the mission of primary distinct from the ability of primary care practices to make the firms richer.  Therefore, practices owned by private equity may well not provide the best possible care for their patients.  In any case, the physicians working for such practices may be answering to owners who are very explicitly only in it for the money.  They will have become corporate physicians, possibly in the most pessimistic sense of the term.

In general, Dr Arnold Relman reminded us that physicians used to shun the commercial practice of medicine (look here).  Physicians and other health professionals who sign on as full-time employees of large corporate entities have to realize that they are now beholden to managers and executives who may be hostile to their professional values, and who are subject to perverse incentives that support such hostility, including the potential for huge executive compensation.  It is not clear why physicians seem to be willing to sign contracts that underline their new subservience to their corporate overlords, and likely trap them within confidentiality clauses that make blowing the whistle likely to lead to extreme unpleasantness.

Things are likely to be even worse for corporate physicians who are employed by firms owned by private equity. Because of the way private equity operates, primary care practices owned by such firms are liable to be very unstable.  At best, they are liable to be sold to totally new owners in a relatively short time frame, and those owners are likely to be those who will pay the highest price, not necessarily those who will provide the best stewardship for the practices.

Furthermore, primary care practices owned by private equity are likely to end up heavily indebted and subject to strict cost cutting measures that may decrease care quality, decrease access, increase patients' out of pocket costs, and demoralize providers.  Practices acquired by private equity may be broken up and sold as separate pieces.  Should the debt be too high, and the cost cutting not be sufficient, such practices could end up bankrupt and possible completely defunct. 

Do not say I did not warn you.

Physicians need to realize that to fulfill their oaths to put patients first, they have to reduce the influence of rich and powerful organizations with other agendas, like health care corporations, and especially corporations owned by private equity.  The metastasis of private equity into primary care should make us all rethink the notion that direct health care should ever be provided, or that medicine ought to be practiced by for-profit corporations. I submit that we will not be able to have good quality, accessible health care at an affordable price until we restore physicians as independent, ethical health care professionals, and until we restore small, independent, community responsible, non-profit hospitals as the locus for inpatient care.

ADDENDUM (28 April, 2015) - This post was re-published on the Naked Capitalism blog.  

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"God Damn the Pusher Man" - Especially when Enabled by the FDA Revolving Door

amphetamines conflicts of interest FDA health care corruption revolving doors You heard it here first

"God Damn the Pusher Man" - Especially when Enabled by the FDA Revolving Door

Unknown 4/13/2015 Komentar

Who is watching the watchers?  A story this week involving "speed" like drugs added to "dietary supplements" suggests how far the once respected US Food and Drug Administration has fallen.

An Amphetamine-Like Drug Spiking "Nutritional Supplements"

The story began with a paper by Cohen and colleagues published a relatively obscure medical journal, and then picked up by the news media.(1)  The main points of the article were:

BMPEA (beta-methylphenylethylamine) is a compound first synthesized in the 1930s as a "potential replacement" for amphetamines.  Animal tests revealed amphetamine-like properties.  The compound was never tested on humans, and never marketed.

But,

BMPEA remained known only as a research chemical until early 2013 when the FDA identified BMPEA in multiple supplements labelled as containing ‘Acacia rigidula’, even though the stimulant has never been identified or extracted from Acacia rigidula, a shrub native to Texas.

However,

More than two years after the FDA's discovery, the FDA has yet to warn consumers about the presence of the amphetamine isomer in supplements.

So Cohen et al undertook to identify "nutritional supplements" said to contain acacia rigidula and test them for BMPEA.  They found 21 such supplements, all of which tested positive. The authors then recommended,

that supplement manufacturers immediately recall all supplements containing BMPEA, and that the FDA use all its enforcement powers to eliminate BMPEA as an ingredient in dietary supplements. Consumers should be advised to avoid all supplements labelled as containing Acacia rigidula. Physicians should remain alert to the possibility that patients may be inadvertently exposed to synthetic stimulants when consuming weight loss and sports supplements.

Note that while the power of the FDA to regulate "nutritional supplements" is limited by a 1994 law, Cohen and colleagues wrote that it

is tasked with identifying and removing mislabelled, adulterated, and dangerous dietary supplements from the marketplace.

Since BMPEA is apparently not found in nature, and was not sold prior to 1994, putting BMPEA in a "dietary supplement" appears to be adulteration. 


The Risks of BMPEA in Nutritional Supplements

The study was then picked up by the media.  In the Los Angeles Times, Pieter Cohen, the lead author of the journal article,

said that while the effects of BMPEA are unknown, the compound is potentially dangerous. He said the FDA's failure to act is 'completely inexcusable.'

Furthermore, in a CBS report,

BMPEA has not been tested in humans, but led to increased blood pressure in cats and dogs.

'These are things that are signals that in humans will later turn into heart attacks, strokes and maybe even sudden death,' Cohen said.

The point is that while it has never been tested fully on humans, there is every reason to suspect that BMPEA acts very similarly to amphetamine, colloquially called "speed."  Amphetamines, as we discussed here, have dangerous side effects, including severe blood pressure elevations, and increased risks of stroke, myocardial infarction (heart attack), and other cardiac events.  The drugs also have a high potential for abuse. 


Why Did the FDA Do Nothing? 

Despite the likely riskiness of BMPEA, the FDA did nothing when it found it in numerous dietary supplements in 2013, and has not indicated that it will do anything now.  According to the LA Times,

FDA spokeswoman Juli Putnam acknowledged that the agency published research on the occurrence of BMPEA in Acacia rigidula supplements in 2013.

'While our review of the available information on products containing BMPEA does not identify a specific safety concern at this time, the FDA will consider taking regulatory action, as appropriate, to protect consumers,' she said.

In a Consumers Report item, Dr Cohen responded to that,

'It’s mind boggling,' said Pieter Cohen, M.D., the Harvard physician who is the lead author of the new study, published online in the journal Drug Testing and Analysis. 'The companies think they have complete impunity. They assume the FDA will do nothing about it. And they’re right.'

A post in the NY Times Well blog reiterated, 

Under federal law, dietary supplements — with some exceptions — can contain only ingredients that are part of the food supply or that were already on the market before 1994. Dr. Cohen said that BMPEA has never been sold as a food or supplement, and as a result any product that contains it is considered adulterated, which would give the F.D.A. the authority to send warning letters to companies that add it to their supplements.

Yet while the FDA had authority to do something, it did nothing.

Was the Revolving Door the Reason?

Back in 2014, we posted about two transitions through the revolving door by the FDA official in charge of the regulation of nutritional supplements.  We reproduce the relevant section of the post below:

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 then question whether that relationship had anything to do with slow responses by the FDA to reports of toxic dietary supplements. 

In 2014, the Times drew no conclusions about Mr Fabricant's career trajectory.  However, this time

But public health experts contend that the F.D.A.’s reluctance to act in this case is symptomatic of a broader problem. The agency is not effectively policing the $33 billion-a-year supplements industry in part because top agency regulators themselves come from the industry and have conflicts of interest, they say. In recent years, two of the agency’s top officials overseeing supplements — including one currently on the job — were former leaders of the largest supplement industry trade and lobbying group.

Daniel Fabricant, who ran the agency’s division of dietary supplement programs from 2011 to 2014, had been a senior executive at that trade group, the Natural Products Association, which has spent millions of dollars lobbying to block new laws that would hold supplement makers to stricter standards. He left the F.D.A. last year and returned to the association as its chief executive. His current replacement at the F.D.A.’s supplement division also comes from the trade group.

'To have former officials in the supplement industry become the chief regulators of that industry at the F.D.A. is like the fox guarding the hen house,' said Michael F. Jacobson, the executive director of the Center for Science in the Public Interest, a consumer advocacy group.

Also, the new Well blog post noted 

Shortly before Dr. Fabricant left the F.D.A. in 2014 to return to the association, the F.D.A. hired another official from the group, Cara Welch. She is now the acting director of the agency’s supplement division. Dr. Cohen, who is also an internist at the Cambridge Health Alliance, said he repeatedly wrote to Dr. Welch asking what the agency was going to do about BMPEA, and that she did not respond.

Dr. Welch declined repeated requests for interviews. In a statement, Juli Putnam, an F.D.A. spokeswoman, said that the agency 'has found that hiring experienced leaders with diverse backgrounds in public health, industry, academia, and science enriches the professional environment and leads to the best health policy outcomes for the American public.'

Before joining the F.D.A., Dr. Welch was the vice president of scientific and regulatory affairs at the Natural Products Association, where she was a staunch defender of the supplement industry. When JAMA, a leading medical journal, raised concerns in a 2011 editorial that the federal law allowed the supplements industry to police itself, Dr. Welch responded that the industry had 'an excellent safety record.'

'The industry itself supports and has implemented strong self-regulatory mechanisms,' she said in an industry news release at the time.

Summary

To summarize, from 2011 to now, the leadership of the part of the FDA that is supposed to regulate dietary supplements was dominated by former top executives of the Natural Products Association, the trade organization for dietary supplement manufacturers.  In 2013, FDA scientists found that multiple dietary supplements contained BMPEA, a compound closely related to amphetamines, and hence potentially dangerous and addictive, although it had never been tested on or previously used by humans.  Although the FDA had authority to do something about this apparent adulteration of these products, it so far had done nothing.  Thus it appears that the currently legal revolving door that allows government regulation to be run by people who come directly from the industries that government is supposed to regulate could be responsible for exposing people to dangerous, addictive drugs.

Remember, BMPEA is a first cousin of amphetamine, amphetamine is "speed," and as the drug epidemics of the 1960s and 1970s showed us, "speed kills."  So a plausible argument is that the revolving door, as relevant to FDA, has enabled manufacturers of nutritional supplements to become the "pusher man," a la the Steppenwolf sound track of Easy Rider,


As we noted here, some experts consider the revolving door per se to be corruption, not merely conflict of interest.  The current case plausibly suggests not only that the revolving door is corrupt, but that when applied to health care can pose dangers to patients, not merely danger to government finances, government ethics, and the integrity of representative democracy.  Nonetheless, up to now, a few people have decried the revolving door (and very occasionally in health care), but nothing has been done about it.   

So it is surprising that today (13 April, 2015), the New York Times published an editorial inspired by the BMPEA case, which concluded

consumer advocates are surely right that putting the industry in charge of supplement regulation is like appointing the fox to guard the henhouse. Clearly, the F.D.A. should not allow industry insiders to fill key positions. A permanent solution is for Congress to enact conflict-of-interest laws forcing employees above a certain grade level at any agency to recuse themselves from official actions that affect a former employer or client, including trade associations and their members.

As a minimum, that would be a good start.  Unfortunately, even a NY Times editorial hardly guarantees action.  At least, however, the problem of the revolving door as a danger to patients has gotten a little less anechoic.

As we last wrote, 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 that have lead to government of, for and by corporate executives rather than the people at large.

ADDENDUM (20 April, 2015) - This post was republished on Naked Capitalism. 


Reference

1.  Cohen PA, Bloszies C, Yee C, Gerona R. An amphetamins isomer whose efficacy and safety in humans has never been studied, beta-methylphenylethylamine (BMPEA), is found in multiple dietary supplements.  Drug Testing Analysis 2015; DOI: 10.1002/dta.1793  Link here.

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