Fool Me Twice? - Boehringer Ingelheim, Medtronic Settle Lawsuits Alleging Deceptive Marketing

It seems like it has been really quiet on the legal settlement front in the US, but maybe corporate executives wanted to wait until things calmed down after the unofficial start of summer to let out news that some people might not think reflected well on them.  So this week it was time to announce two new legal settlements of allegations of bad behavior by corporate health were announced, as we will list in alphabetical order....

Boehringer Ingelheim Settles Suits Alleging it Hid Data About Pradaxa Harms

As per Bloomberg,

Boehringer Ingelheim GmbH, the German family-owned drugmaker, agreed to pay $650 million to settle the majority of lawsuits filed over its blood thinner Pradaxa, which has been linked to more than 500 patient deaths.

The major allegations were about deception,

 Patients and their families alleged Boehringer executives knew Pradaxa posed a deadly risk to some consumers when they brought it to the U.S. market in October 2010.

In particular, as we discussed in more detail in February, 2014,

Documents made public as part of patients’ Pradaxa suits showed Boehringer officials didn’t disclose to U.S. regulators a data analysis that indicated the blood-thinning drug may have caused more fatal bleeding after it was cleared for sale than in a study used to win approval. 

Per the New York Times, Boehringer Ingelheim executives continued to maintain

that it stood behind the safety and efficacy of Pradaxa and continued to believe that the lawsuits lacked merit, but that settling the case allowed the company to move on. 'Time and again, the benefits and safety of Pradaxa have been confirmed,' said Desiree Ralls-Morrison, senior vice president and general counsel of Boehringer Ingelheim USA.

This is typical of most legal settlements involving large health care organizations, whether they end lawsuits brought by private parties or by the US government.  The settlements often allow the parties to continue to disagree, do not establish guilt or innocence, but leave one to wonder why executives would pay so much of admittedly other peoples' money just to "move on" without upholding their or their companies' honor, especially when documents revealed and legal findings made in cases prior to settlement remain unchallenged.

So this settlement also comes after December, 2013, as we discussed here, December, when a judge

ordered Boehringer to pay a $931,000 fine in December for failing to preserve 'countless' files on Pradaxa’s development and marketing. Patients’ lawyers say Boehringer should have placed an effective 'litigation hold' on the documents, forcing employees to preserve them.

(The above per Bloomberg.)  That finding, which the settlement does not dispute, does not fill one with confidence about the openness and transparency of Boehringer Ingelheim managers.

Also the settlement does not refute documents released during this litigation which suggested that Boehringer Ingelheim personnel tried to influence, or manipulate a company sponsored research paper to prevent it from contradicting the company's official marketing message that Pradaxa administration does not require monitoring of patients with blood tests (as we discussed here).    

Note further that this case comes only a few years after a case in which Boehringer Ingelheim settled allegations of deceptive marketing of drugs other than Pradaxa, as we discussed here.

Medtronic Settles Suit Alleging Kickbacks to Physicians

The most extensive and colorful report was in the Minneapolis Star-Tribune,

Medtronic Inc. will pay the U.S. Justice Department $9.9 million to settle a whistleblower lawsuit that accused the company of paying kickbacks to doctors for using its defibrillators and pacemakers.

The alleged kickbacks, according to the newly unsealed suit, included 'gifts of wine and alcohol' and 'trips to strip clubs' paid for by the Fridley-based company. The lawsuit also says Medtronic paid to fly doctors to events in San Francisco, Las Vegas, New Orleans, New York, Minneapolis and other cities that some physicians used as 'a free vacation.'

More colorful details,

The lawsuit, whose details remained secret until Tuesday, describes Medtronic business plans with names such as 'Project Wildfire' that had sales representatives offer 'cash payments, expensive trips and meals, expensive gifts and entertainment to physicians as kickbacks in exchange for the physicians’ agreement to implant Medtronic devices.'

The lawsuit alleged that Medtronic 'funneled millions of dollars in unrestricted grant money to physicians' to get them to encourage the use of Medtronic defibrillators and pacemakers in patients whose 'mild heart failure symptoms did not meet [Food and Drug Administration] criteria for an implantable device.'

Those procedures were not only unnecessary, the suit alleged, but potentially dangerous.

The suit describes payments of thousands of dollars in speaking fees to doctors for attending dinners at which they spoke for only a few minutes, if at all. In other cases, Medtronic allegedly prepared entire presentations that physicians offered almost verbatim.

The suit talks of a plan that 'instructed sales representatives to personally review patient charts in friendly doctor’s offices' and to flag those patients the sales representative 'felt should receive an implant.'

Note that commercially supplied "unrestricted grant money" is now the lifeblood of many ostensibly academic continuing medical education (CME) programs, but this case suggests that corporate executives may believe they are paying such money to get doctors to use their products.  Note further that many physicians defend their receipt of money in payment of talks they have given on behalf of commercial firms as fair payment for providing unbiased education, but this case suggests that corporate executives may believe they are paying such money for marketing, and/or to get the supposedly unbiased physician speakers to use their products. 

Once again, the settlement did not resolve the allegations.

 Medtronic said it did not admit that any of its activities were improper or illegal and that the settlement would bring to a close a long-running review of events dating from 2001 to 2009.

Also,

 Asked to comment specifically on the strip club allegations and the accusation that it financially facilitated unnecessary implantations, Medtronic reiterated that its $9.9 million payment was not an admission that it had done anything illegal or improper.

See my comments above.  Why would executives with even the slightest ability to feel shame not contest such allegations if they were untrue?  But maybe many of today's corporate health care executives are not capable of feeling shame, and of course they get to pay off these lawsuits with other peoples' money.

By the way, this is just one of many Medtronic settlements.  As Bloomberg summarized,

 Medtronic agreed in 2007 to pay about $130 million to settle consumer suits accusing the device maker of hiding defects in its defibrillators. The company agreed to a $268 million settlement of suits in 2010 over allegations that fractured wires in another line of defibrillators caused at least 13 patient deaths.

In fact, Medtronic has provided our blog with lots of material.  We first discussed detailed and vivid allegations that Medtronic had been paying off doctors starting in 2003 here in 2006.  Medtronic has been involved in other lawsuits alleging various kinds of deception.
-  In 2011, it settled for $23.5 million two other federal lawsuits alleging it paid kickbacks to encourage physicians to implant its devices (look here).  
- In 2008, Medtronic subsidiary Kyphon settled a suit for $75 million and signed a corporate integrity agreement for allegations that it defrauded Medicare through a scheme that lead to excessive hospitalization for patients who received the company's spine surgery device (link here)
- In 2006, Medtronic subsidiary Sofamor Danek settled for $40 million allegations that it gave kickbacks to doctors in the form of sham consulting fees and lavish trips (look here).

Yet we are now writing at the end of May, 2014, and Medtronic is still settling lawsuits involving vivid allegations of payoffs to physicians, and its executives are still saying nothing to see here, move on.

Summary

These sorts of cases provide evidence that large health care corporations, including not just pharmaceutical companies, but biotechnology and medical device companies, commonly use deceptive and unethical practices to market their products.  Such marketing lets them charge high, even outrageous prices and sometimes results in patients getting expensive treatments that do them no good, or worse, that do more harm than good.  Some of the executives of these companies doubtless got large bonuses, and may have gotten millions in compensation partially because of the sales generated by these practices.  However, they get to walk away from such lawsuits without any personal accountability, just by paying out a few millions, or billions, of the company's, that is, other peoples' money.  They get do pay that money without any other explanation that it eliminates distractions and allows them to move on (with whatever they have already made).

The more this goes on, the more health care dysfunction continues, and the more the health care oligarchy prospers.  As we have written many times,

penalties that only appear to be (relatively small) costs of doing business are unlikely to deter future bad behavior. Until the people who actually authorized, directed and implemented the bad behavior have to suffer some negative consequences, expect the bad behavior to continue.  Note that each of the companies discussed above have had their previous ethical lapses discussed in previous Health Care Renewal posts.

The continuing march of settlements, and sometimes criminal convictions involving major health care organizations should be regarded merely as providing a floor to estimates of the extent of bad behavior by large health care organizations. Bad behavior may not be reported, or lead to legal action, and legal action may not lead to settlements or convictions. However, it is amazing how many organizations that were once regarded as exemplary have had to settle, or plead guilty, or been convicted.

When it comes to health care's leadership, society seems to have acceded to defining deviancy down. Until we start holding health care leaders to high standards, expect their organizations not to uphold high standards.

(That version was from 2010, posted here re Medtronic's 2010 settlement. You heard it here first.  Medtronic is still settling, and according to its most recent proxy, from 2013, the annual total compensation of its CEO was last reported to be $8,975,886.)

Planned Obsolescence Disguised as Innovation, Oligopoly Disguised as a Free Market, and the Enrichment of Oligarchs

The New York Times published another article in its series on the high cost of US health care.  This one, focused on the care of type 1 diabetes mellitus and other chronic diseases, shines some light on the business management practices that now determine how our health care system functions, or not, and implies who benefits the most from them.

Planned Obsolescence Disguised as Innovation

The article first discussed the brave new world of type 1 diabetes treatment.  The introductory theme was:

Today, the routine care costs of many chronic illnesses eclipse that of acute care because new treatments that keep patients well have become a multibillion-dollar business opportunity for device and drug makers and medical providers.

Much of modern diabetes treatment seems to depend on medical devices and disposable medical supplies:

That captive audience of Type 1 diabetics has spawned lines of high-priced gadgets and disposable accouterments, borrowing business models from technology companies like Apple: Each pump and monitor requires the separate purchase of an array of items that are often brand and model specific.

A steady stream of new models and updates often offer dubious improvement: colored pumps; talking, bilingual meters; sensors reporting minute-by-minute sugar readouts. [Diabetes patient] Ms. Hayley’s new pump will cost $7,350 (she will pay $2,500 under the terms of her insurance). But she will also need to pay her part for supplies, including $100 monitor probes that must be replaced every week, disposable tubing that she must change every three days and 10 or so test strips every day.

Of course, the device and supply manufacturers claim that the high prices reflect the value of the wondrous new innovations:

Companies that produce the treatments say the higher costs reflect medical advances and the need to recoup money spent on research.

Yet now the Times reporter was able to find physicians who claim the "innovations" are really just the latest version of planned obsolescence:

Diabetes experts say a good part of what companies label as innovation amounts to planned obsolescence. Just as Apple customers can no longer buy an iPhone 3 even if they were content with it, diabetics are nudged to keep up with the latest model.

For example,

Those companies spend millions of dollars recruiting patients at health fairs, through physicians’ offices and with aggressive advertising — often urging them to get devices and treatments that are not necessary, doctors say. 'They may be better in some abstract sense, but the clinical relevance is minor,' said Dr. Joel Zonszein, director of the Clinical Diabetes Center at Montefiore Medical Center.

'People don’t need a meter that talks to them,' he added. 'There’s an incredible waste of money.'

Pharmaceutical companies have also discovered this model.

insulin ... has been produced with genetic engineering and protected by patents, so that a medicine that cost a few dollars when Ms. Hayley was a child now often sells for more than $200 a vial, meaning some patients must pay more than $4,000 a year.

In particular,

Synthetic human insulin is safer for patients, who sometimes developed reactions to animal insulin. But it is made by only three companies: Eli Lilly, Sanofi and Novo Nordisk. Manufactured in microbes, each one’s product has minor dissimilarities that reflect the type of cell in which it was made. Since the companies owned the cell lines, it is nearly impossible for other companies to make exact copies or even similar versions that would be cheaper, even once the patents expire. And the pharmaceutical companies defend the patents ferociously.

What’s more, the three companies continued to refine their product, adding chemical groups that made the insulin absorb somewhat more quickly or evenly, for example. They are called insulin analogues, and their benefits are promoted tirelessly to doctors and patients.

Of course, the pharmaceutical companies also claim that it's all about innnovation,

Dr. Todd Hobbs, chief medical officer of Novo Nordisk, defended the rising prices of insulin, linking them to medical benefits. 'The cost to develop these new insulin products has been enormous, and the cost of the insulin to the consumer in developed countries has risen to enable these and future advancements to occur,' he wrote in an email.

 Not everyone is convinced,

'The insulins are tweaked for minor benefits that may help a small number of patients with difficult-to-control diabetes, and result in major price increases for all,' [Kings College, London, UK Professor] Dr. Pickup said. Because of analogues, he added, Britain’s National Health Service has had to spend 130 percent more on insulin in the past five years.

In the United States, said Dr. Zonszein at Montefiore, the price of Humalog, Lilly’s analogue insulin, was typically two to four times that of its older human insulin line, called Humulin. 'There is not a lot of difference between Humulin and analogues,' he said, but he noted that Humulin was getting 'hard to find.' Sanofi Aventis has stopped selling its older product in the United States, and Mr. Kliff, the financial analyst, said other companies were likely to follow suit, effectively forcing patients to use the costlier versions.

The arguments about valuable innovation also do not explain why the prognosis of diabetes in the US does not seem to reflect all the money we spend on the disease,

Complication rates from diabetes in the United States are generally higher than in other developed countries. That is true even though the United States spends more per patient and per capita treating diabetes than elsewhere, said Ping Zhang, an economist at the Centers for Disease Control and Prevention.

The high costs are taking their toll on public coffers, since 62 percent of that treatment money comes from government insurers. The cumulative outlays for treating Type 1 and Type 2 diabetes reached nearly $200 billion in 2012, or about 7 percent of America’s health care bill.

So to summarize, there is considerable evidence that companies that make drugs and devices to manage type 1 diabetes constantly provide "innovations," yet most are minor changes that encourage obsolescence of previous products, but do not provide important increases in benefits or reductions in harm for patients. 


Oligopoly Disguised as a Free Market

Many in the US sing the praises of our supposed free-market health care system.  As noted above however, the insulin market is an oligopoly, dominated by three companies.  The diabetes device market is also dominated by a few companies, and in particular, the insulin pump market is dominated by a single company,

Medtronic is the dominant insulin pump manufacturer, serving 65 percent of American patients and the majority of those worldwide. Though smaller companies sell cheaper pumps, it is hard to make inroads: Once familiar with the Medtronic system and its extensive support network for troubleshooting problems, patients are reluctant to switch. Doctors are leery of prescribing equipment from a new company that may be out of business in a year; their office computer may not sync with the new software anyway.

Of course, Medtronic public relations will justify it all again based on innovation,

Medtronic declined to talk about specific prices, but said a core tenet was to make only 'a fair profit.' Amanda Sheldon, a spokeswoman, added: 'We are committed to reinvesting in research and development of new technologies to improve the lives of people with diabetes, and our current pricing structure ensures that we can bring new products to market.'

The article also discussed the prices of treating chronic diseases other than diabetes.  For example, see how a nominally non-profit hospital priced treatments for chronic diseases,

Dr. Kivi was on high doses of steroids for debilitating joint pain that left him unable to walk at times.

But when his last three-hour infusion at NYU Langone Medical Center’s outpatient clinic generated a bill of $133,000 — and his insurer paid $99,593 — Dr. Kivi was so outraged that he decided to risk switching to another drug that he could inject by himself at home. 

However,  this pricing appears to have been facilitated by the hospital's increasing market domination generated by its purchase of physician practices,

He had moved his care to NYU Langone to follow his longtime doctor, who had moved her practice from a nearby hospital where the same infusion had been billed at $19,000. The average price that hospitals paid for Dr. Kivi’s dose of Remicade late last year was about $1,200, according to Medicare data.

So in summary, a few companies now dominate the production of drugs and devices for the management of diabetes, and a few large hospitals may increasingly dominate the treatment of particular chronic diseases.  Such oligopolists are able to increase prices without improving treatment to or outcomes of patients.

Enrichment of the Oligarchs

This example shows how the current US health care system is dominated by huge organizations, mostly for-profit corporations but including some nominally non-profit corporations that act similarly.  They loudly proclaim innovation, but much of that innovation seems to provide few benefits to patients, and actually appears to be planned obsolescence.  The result is high and ever-rising prices. So if patients do not benefit from this, who does?

It does not appear to be the health care professionals,

Meanwhile, as the price of supplies rises, endocrinologists remain among the lowest-paid specialists in American medicine, meaning severe physician shortages in many areas and long waits to see a doctor.

We  have seen other examples of how leaders of the big health care organizations have become as rich as royalty.  Therefore, let us consider the pay of the leaders of the organizations mentioned above.  I will focus on the two US based corporations, Eli Lilly and Medtronic, and the New York hospital, NYU Langone Medical Center.

Eli Lilly

According to the company's 2014 proxy statement, the 2013 total compensation of its five highest paid hired executives was

- John C Lechleiter PhD, CEO                                      $11,217,000

- Derica W Rice, CFO                                                   $5,176,822

- Jan M Lundberg, PhD, EVP, Science and Technology   $4,774,535

- Michael J Harrington, General Counsel                          $3,174,222

- Erico A Conterno, President Lilly Diabetes                    $3,009,041

Note that all of these executives save Mr Harrington have also amassed more than 100,000 shares of company stock, and Dr Lechleiter has amassed more than 1,000,000.

It should be no surprise, given our recent discussion (e.g., here) of the currently symbiotic relationship among top health care corporations and academic medicine, that several of the members of the Lilly board of directors that has exercised stewardship over the company, and is thus responsible for these gargantuan compensation packages and the business practices discussed above are top academic leaders.  These include,

- Alfred G Gilman, MD, PhD, Regental Professor Emeritus, recent (until 2009) executive vice presdient, provost, and dean of medicine, University of Texas Southwestern 

- William G Kaelin Jr, MD, Professor of Medicine, Associate Director of Basic Science, Dana-Farber Cancer Center, Harvard University

- Marschall S Runge MD, Executive Dean and Chair of the Department of Medicine, University of North Carolina Medical School

- Katherine Baicker PhD, Professor of Health Economics, Harvard University School of Public Health  (I must note that Prof Baicker is also - amazingly - on the Medicare Payment Advisory Committee, MEDPAC).

- Ellen R Marram, Trustee, New York-Presbyterian Hospital

- Ralph Alvarez, President's Council, University of Miami

- R David Hooper, Trustee, Children's Hospital of Colorado

- Franklyn G Pendergast MD PhD, Professor, Mayo Medical School

All but the newest directors were paid at least $250,000 a year by the company (and thus by the executives the directors are supposed to supervise), and all but the newest directors had accumulated tens of thousands of shares of stock or the equivalent as pay for their services.


Medtronic

Similarly, according to the company's 2013 proxy (the latest now available), CEO Omar Ishrak made $8,975,866 in 2013, and the next four highest paid executives all made over $2,500,000 each.   Mr Ishrak owned or could acquire the equivalent of more than 500,000 shares of stock, and the other top paid executives owned of could acquire from over 100,000 to over 1,000,000 shares of stock.

Again, the executives were nominally supervised by a board of directors that included an academic and non-profit leader, Dr Victor J Dzau, MD former chancellor for health affairs at Duke University, and president-elect of the Institute of Medicine (note that we discussed Dr Dzau's conflicts of interest most recently here).  It also included a former government leader, Michael O Leavitt, former US Secretary of Health and Human Services; and a hospital leader, Preetha Reddy, Managing Director of Apollo Hospitals Enterprise Limited (India). 

NYU Langone Medical Center

The Medical Center's 2011 US form 990 is old, but the latest available, and is remarkably obscure, omitting, for example, mentioning the titles of any of the people listed as highest paid officers and employees.  The current CEO, was listed as receiving total compensation of just over $2.000,000.  Four individuals then received over $1,000,000.  The 990 form also mentioned that the Medical Center provided some individuals with first class travel, tax gross-up payments, housing allowances, and reimbursement for personal services.  Neither the 990, nor the center's web-site makes all the possible conflicts of interest of its trustees obvious.   

So in summary, the large organizations, for-profit and non-profit, that are able to greatly increase their prices through planned obsolescence disguised as innovation, and oligopoly disguised as free markets, are able to make their top executives very rich, and also enrich those who are supposed to exercise stewardship over them. 


Summary

An extensive journalistic investigation revealed how certain aspects of chronic care in the US health care system are dominated by a few large organizations.  These organizations are able to charge very high prices, mainly through market domination, and with the aid of marketing and public relations that tout planned obsolescence as valuable innovation.  The leaders of these organizations have become wealthy, often fabulously so.  This state of affairs has not been challenged by those who are supposed to provide stewardship, including many prominent academics.

The US health care system is the most expensive, on a per capita basis, in the world, and far more expensive than that in any other developed country.  Yet there is no evidence that its results are superior to those of other countries.  What evidence there is suggests in fact that our results are mediocre at best.

The current example suggests how the US system differs from those of other countries.  It has an ostensible free market focus.  Yet the system appears more to be an oligopoly, with most of its market components dominated by a few large organizations, run as an oligarchy, by a small, overlapping in-group of managers, executives and their cronies, with elements of corporatism, that is with the cooperation of, rather than regulation by government entities and leaders

A real free market health care system would include a level playing field.  This could only be achieved by the government acting as a fair umpire, not a crony.  Anti-competitive practices would have to end.  Oligopolies would have to be broken.  Deceptive marketing and public relations would have to be exposed.  Leaders would have to be made accountable, especially for putting patients' and the public's health ahead of their own enrichment.  All this would be horribly difficult, as the oligarchs have amassed much money and control, and would oppose, possibly violently, any effort to challenge them.  If we do not challenge them in the US, however, not only will our health care continue to become ever more expensive, less accessible, and less beneficial to patients, but we will all cease to be citizens of one of the first real democracies, and end up serfs instead. 

Incoming President of IOM Outed as Member of Boards of Alnylam Pharmaceuticals, Medtronic and Pepsico

We just discussed how the new CEO of the National Quality Forum was revealed to be a member of the board of directors of Premier Inc, and discussed the implications of this apparently intense conflict of interest. 

Now another new leader of an influential non-profit organization dedicated to improving health and health care has also been shown to have major conflicts of interest.

All Hail the New President of the Institute of Medicine

In 2010, we posted about a student protest of the salaries of some top administrators at Duke University, including then Chancellor of Health Affairs Dr Victor Dzau, at a time when the university was undergoing financial difficulties.  We pointed out that Dr Dzau's income was further increased by compensation received as a member of the boards of directors of multiple corporations, and further that serving as a highly paid steward of health care companies like Alnylam Pharmaceuticals, Genzyme, and Medtronic appeared to be a major conflict of interest.  .  

Last week Dr Victor Dzau was hailed as the new president of the Institute of Medicine.  The simple version, in Modern Healthcare:

 Duke University Health System President and CEO Dr. Victor Dzau was named president of the Institute of Medicine, succeeding the longtime president, Dr Harvey Fineberg, the National Academy of Sciences announced Wednesday.

Dzau, whose six-year term will begin July 1, has done research in the area of treatment for high blood pressure and congestive heart failure and pioneered the use of gene therapy for vascular disease, the institute said in announcing the selection. Dzau served on the IOM Council from 2008 through 2013, Fineberg said in a statement.

'As a physician-scientist and leader in academic medicine, Victor has consistently demonstrated inspirational leadership, innovative thinking and multifaceted achievement. Now, all of us at the IOM, both members and staff, will benefit more fully from his leadership,' said Fineberg, who has served as president of the institute for 12 years.

Conflicts of Interest Barely Noted

Neither this article, the official Institute of Medicine press release, nor articles in the few media outlets that initially covered this new appointment on 19-20 February, 2014,, including the Boston Globe and the Charlotte News-Observer, noted Dr Dzau's positions on the boards of directors of Alnylam Pharmaceuticals, device manufacturer Medtronic, and sugary soft drink maker Pepsico.

However, Forbes blogger Larry Husten, was the first to publicly report these memberships, drawing on our 2010  post  on Dr Dzau's conflicts of interest as Duke Chancellor for Health Affairs.

Then a blog post on Modern Healthcare by Steven Ross Johnson added some more detail,

IOM spokeswoman Jennifer Walsh said in an e-mail that Dzau initiated steps to resign from his corporate board positions before Wednesday's announcement and that he has committed to severing the ties by the time he begins his six-year term in July.

It did not mention why the IOM press release and the initial news stories did not mention Dr Dzau's board memberships nor his intention to resign from them.  The IOM spokeswoman apparently did not discuss why Dr Dzau was going to resign his board memberships now, while he had maintained them as a member of the IOM Council from 2008 to 2013.

Since then, later on 21 February, a single mainstream media article, in Bloomberg, did address Dr Dzau's new job, his corporate board memberships, and his planned resignations, with emphasis on his break from PepsiCo:

The newly appointed president of the Institute of Medicine, which advises government leaders and policymakers on health issues, plans to resign from several corporate boards in advance of taking his new job—including one that might have created a sticky situation.

Among the companies that Victor Dzau will sever ties with is PepsiCo (PEP), according to Jennifer Walsh, a spokeswoman for the IOM. 'Dr. Dzau had already decided to step down from corporate boards before he accepted the position,' she says.

For Dzau, who’s leaving his position as chief executive officer of the Duke University Health System to head up the IOM, the PepsiCo relationship might have been a problem: Several of the company’s products are among those blamed for contributing to the obesity epidemic in the U.S. The Purchase (N.Y.)-based company is best known for its Pepsi soft-drink line and snacks including Fritos and Cheetos.

The IOM, which has identified solving the nation’s weight problem as a top priority, endorsed the idea of a soda tax in a report detailing the 'staggering toll' of obesity. The agency estimates obesity-related illness in the U.S. costs $190 billion a year.

The Bloomberg article mentioned his memberships on the Alnylam and Medtronic boards mainly in passing.

The Rewards of Board Membership


The Modern Healthcare blog post provided a list of recent compensation Dr Dzau received from his board memberships.

According to Pepsico's 2013 proxy statement, Dzau deferred his retainer of $66,667 for the year ending Dec. 29, 2012, in lieu of 944 units of phantom stock, where cash is paid at a future date in an amount equal to the market value of stock shares. Dzau also serves on the boards of Alynylam Pharmaceuticals (he was paid $50,000 and received option awards of $89,000 in 2013) and medical devicemaker Medtronic (PDF) (he was paid $80,000 and received stock awards worth $140,000 in 2013).

It did not mention whether he currently owns any stock, or the equivalent, in any of these companies. 


However, the most recent Alnylam, Medtronic, and PepsiCo proxy statements show Dr Dzau's considerable stock holdings in these companies.

- According to the 2013 Alnylam Pharmaceuticals proxy statement, he currently owns the equivalent of 90,000 shares today worth $8,070,300 at the current price of $89.67.
- According to the 2013 Medtronic proxy statement, he currently owns 9636 stock options and 15,200 deferred stock units for total holdings of 25,156 share equivalents today worth $1,450,495 at a current price of $57.66.
-  According to the 2013 Pepsico proxy statement, Dr Dzau currently owns the equivalent of  36,173 shares of Pepsico stock. today worth $2,830,537 given a current price of $78.25. 

The Bloomberg article provided a somewhat lower estimate of the value his PepsiCo stock holdings based on an otherwise unidentified 2 December, 2013 filing with the US Securities and Exchange Commission.  It estimated the value of his deferred stock units in Medtronic based on an April, 2013 disclosure, but did not list the stock options which appeared in the July, 2013 proxy statement.  It noted his membership on the Alnylam board but did not mention that he held any shares or the equivalent in Alnylam stock.

I cannot find anything public about what, if anything, Dr Dzau plans to do with these not inconsiderable stock holdings in health care and health related corporations.  

Note that as we posted in 2010, in its last proxy statement before it was acquired by Sanofi, Genzyme declared that Dr Dzau owned the equivalent of 75,137shares as of 2009, which in 2010 were worth approximately $5.3 million.  I cannot tell what Dr Dzau did with these stock holdings after the merger.  


Thus while there may be some confusion about this current holdings and their exact value, it seems clear that Dr Dzau has become a multimillionaire by virtue of his holdings of stock or equivalent from the three companies, a drug company, and medical device company, and a company whose products have apparent public health implications, on whose boards he currently sits, and possibly by virtue of his holdings in another drug/ biotechnology company on whose board he previously sat.  .  

The Intensity of the Conflicts

The acuity of the conflicts presented were the President of the IOM to continue sitting on these boards was emphasized by this description of the influence wielded by the IOM written in an article in the Durham (NC) Herald-Sun,

 Under the congressional charter of the National Academy of Sciences, the Institute of Medicine is recognized as a primary source for independent, scientifically informed analysis and recommendations on health issues.

Even though Dr Dzau will apparently exit his board memberships before he becomes IOM President, the IOM  has been providing such analysis and recommendations under the supervision of a Council member who had fiduciary duties to the stockholders of two pharmaceutical companies a medical device company, and company that makes sugar-laden soft drinks and snack foods.  It will continue to provide such analysis and recommendations under the supervision of a President who became a multimillionaire by virtue of the stock holdings he acquired through his board positions.


In 2006 we first discussed a newly discovered species of conflict of interest in health care, in which leaders of medical or health care organizations were simultaneously serving on boards of directors of health care corporations.  We posited these conflicts would be particularly important because being on the board of directors entails not just a financial incentive.  It ostensibly requires board members to "demonstrate unyielding loyalty to the company's shareholders" [Per Monks RAG, Minow N. Corporate Governance, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.]  Of course, after the global financial collapse of 2008 made us sadder and a little wiser, we realized that many board members actually seem to have unyielding loyalty to their cronies among top management.  However, in any case, the stated or actual interests of a member of the board of a health care corporation, like a pharmaceutical company or medical device company, could be very different and at odds with the mission of an academic medical institution or a non-profit ostensibly dedicated to improving health care quality.

Also, this case could be aggregated with that of Dr Cassel, the new CEO of the National Quality Forum (and former CEO of the American Board of Internal Medicine) who was found to be a member of the board of directors of Premier Inc, a for-profit hospital group purchasing organization.(see this post).  In my humble opinion, the issue here goes even beyond blatant conflicts of interest.  That top stewards of big for-profit health care corporations could simultaneously be  top leaders of influential non-profit organizations ostensibly dedicated to improving health and health care suggests that increasingly US health care is run by an insular group of insiders whose influence gets ever larger because of their collective power, not necessarily because of their dedication or ability to improvement of health care.  As reported by ProPublica about Dr Cassel's case,

Rosemary Gibson, an author and senior adviser to The Hastings Center, a research group dedicated to bioethics in the public interest, said she wasn’t surprised at Cassel’s outside compensation. So much money permeates decision-making in Washington, she said, that participants have become oblivious.

'The insiders don’t see it,' Gibson said. 'It’s like a fish in water.'

How Would Dr Dzau Respond to Criticisms of the Companies He Directs, and How Would His Responses Reflect on the IOM?

Even if  Dr Dzau were to resign from all three corporate boards, and sells all his stock holdings in the three companies, as previous board member he was responsible for the stewardship of these four companies for years. Therefore it would not be unfair for someone to ask him to address any questionable actions of those companies that affected patients' and the public's health.

For example, as we have discussed here, Medtronic has been involved in a series of recent misadventures, including most recently a settlement between multiple hospitals and the Us Department of Justice of charges that they allowed themselves to be persuaded by executives of Medtronic subsidiary Kyphon to inflate their billings for patients who had a Kyphon device implanted (look here),  and a Senate report that Medtronic manipulated articles in the medical literature to market another of its products (look here).

But the awkward fact is that Dr Dzau, as a board member of Medtronic, can be seen to be a steward of that corporation, and hence responsible for the its overall direction.  Even if he were no longer a board member, he cannot erase his responsibility for Medtronic activities that occurred on his watch.  Thus, Dr Dzau could easily find herself in the uncomfortable situation of having to defend and justify questionable past behavior by Medtronic while simultaneously wearing the hat of President of the IOM.  How that would play out is not obvious.

Summary

To date, the case of Dr Dzau as incoming president of the IOM and current board member of Alnylam Pharmaceuticals, Medtronic and Pepsico has received little attention, and therefore no ethics expert has gotten a chance to speak up in public about it, as they have about the case of Dr Cassel, the NQF, and Premier Inc.  So I will have to step in.

As I have said before,  Dr Joe Collier said, "people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult."  [Collier J. The price of independence. Br Med J 2006; 332: 1447-9. Link here.]  To reduce further unclear thinking and its consequences, we again urge that academic medical institutions, and non-profit organizations dedicated to improving patient care and public health forthwith begin real reductions of conflicts of interest affecting all those who make clinical or policy decisions.

The IOM ought to consider
-  Immediately disclosing conflicts of interest affecting all its members, staff, and leadership in a very clear and accessible manner
-  Beginning a gradual but complete phase out of such conflicts

Otherwise, we all ought to be concerned that the leadership of medicine and health care is increasingly in the hands of a small group of insiders, interchangeable executives who simultaneously or sequentially lead multiple organizations, and are likely to become more comfortable with the fellow members of this interlocking leadership than with ordinary health care professionals, patients and the public.   

55 of Medtronic's Best Hospital Friends, Including HCA, Settle for $34 Million

The case of the over-marketing of Kyphon's kyphoplasty device (look here) just got more complicated, and now appears to have involved an amazing number of players.

The State of Play

 As reported by the AP (via the Washington Post),

 Fifty-five hospitals in 21 states have agreed to pay $34 million to the U.S. government to settle allegations that they used more expensive inpatient procedures rather than outpatient spinal surgeries to get bigger payments from Medicare, the U.S. Justice Department said Tuesday.

The settlement involves kyphoplasty procedures used to treat spinal fractures usually caused by osteoporosis. It can be done as an outpatient procedure, but he Justice Department said the hospitals performed the surgeries as inpatient procedures to increase Medicare billings.

The current media reports provided little detail about the allegations, but did note that this case has been litigated for a while,

 A similar settlement was reached last year, when 14 hospitals agreed to pay a settlement of more than $12 million. And in 2008, the Justice Department agreed to a $75 million settlement with Medtronic Inc.’s spine business. The government was investigating allegations that Kyphon, a company that had been acquired by Medtronic Spine in 2007, advised hospitals to do inpatient kyphoplasties to bulk up their Medicare payments.

The Players

Per the AP, there were quite a few

In the latest settlement, the largest payments are being made by Atrium Medical Center of Middletown, Ohio, which will pay $4.2 million; Mount Sinai Medical Center in Miami, $1.8 million; Altru Health System of Grand Forks, N.D., $1.5 million; Cedars Sinai Medical Center in Los Angeles, $1.5 million; Wayne Memorial Hospital in Goldsboro, N.C., $1.3 million; Trover Health System of Madisonville, Ky., $1.2 million; The Queen’s Medical Center in Honolulu, $1.1 million; and Des Peres Hospital in suburban St. Louis, $900,000.

Several multi-hospital organizations agreed to settlements, including:
—Twenty-three hospitals with HCA Inc. of Nashville, Tenn., paying a total of $7.1 million.
—Six hospitals with Lifepoint Hospitals Inc. of Brentwood, Tenn., $2.5 million.
—Five hospitals with Trinity Health of Livonia, Mich., $3.9 million.
—Four hospitals with Morton Plant Mease BayCare Health System of Clearwater, Fla., $2.4 million.
—Three hospitals with Baptist Memorial Hospital-Golden Triangle of North Columbus, Miss., $1.8 million.
—Two hospitals with Bayhealth Medical Center of Newark, Del., $1.1 million.

A Modern Healthcare report noted that the leadership of HCA, the hospital system with the largest liability, made it out to all be a misunderstanding,

Hospital executives say the allegations are prompted by  unclear Medicare rules on when spinal-surgery patients should be held overnight. And they note that even though the whistle-blowers and the government are targeting hospitals, the decision to admit patients is usually dictated by the treating physician.

'We are pleased to see new clarification of industry care standards, which help physicians make decisions regarding kyphoplasty patients,' HCA spokesman Ed Fishbough said in an e-mailed statement Tuesday. 'We are confident as a result that this issue has been resolved.'

However, the case appears to be more complicated than that.

What Really Happened, and Who Benefited?

In fact, we discussed the Medtronic settlement in 2008.  At that time, a New York Times article described the government's allegations about what went on this way,

A unit of Medtronic defrauded Medicare of hundreds of millions of dollars, according to a civil lawsuit that was unsealed Thursday and simultaneously settled with the Justice Department.

Two insiders had said Kyphon, which Medtronic acquired in 2007, improperly persuaded hospitals to keep people overnight for a simple outpatient procedure to repair small fissures of the spine. Medicare then reimbursed the hospitals much more generously than it otherwise would have for the procedure, which was developed as a noninvasive approach that could usually be done in about an hour.

By marketing its products this way, Kyphon was able to artificially drive up demand among hospitals, bolstering its revenue and driving up its stock price. Medtronic subsequently bought the company, its competitor, for $3.9 billion, greatly enriching Kyphon’s senior executives.

Furthermore,

 The scheme at Kyphon was based on Medicare’s practice of reimbursing hospitals more for complex inpatient back surgery than for outpatient care. The two whistle-blowers, Charles M. Bates and Craig Patrick, said Kyphon had deliberately urged doctors to admit patients overnight, knowing the admissions were unnecessary.

Hospitals saw the overnight admissions as a way to raise revenue, the two said, and bought Kyphon’s products, even though they were expensive, starting at $3,500 to repair one spinal fissure. The hospitals could recover the cost through the improper reimbursements for overnight stays.

Kyphon sold so much equipment this way that at one point it enjoyed a 90 percent profit margin, according to the two insiders, both of whom worked in sales positions.

The former employees said the scheme began in 1999, when Kyphon’s products first came to the market. Kyphon’s rapid sales growth and profitability eventually gave rise to a patent dispute with Medtronic, which was dropped when Medtronic acquired it. The acquisition richly rewarded Kyphon’s shareholders, particularly its top executives. The company said its top 15 executives stood to receive about $145 million by cashing in their options and restricted stock.

Note that at that time, Medtronic leadership, whose decision to purchase of Kyphon would end up so enriching Kyphon executives, seemingly had no worries,

A  spokeswoman for Medtronic, Marybeth Thorsgaard, said the company had known Kyphon was under investigation when it made the acquisition. She said it knew that Kyphon’s marketing strategy was being challenged, and took the risk of litigation into account. 'There were no surprises,' she said.

I can find no public record that any individual who authorized, directed, or implemented the arrangements above that lead to huge overcharges to Medicare, and huge revenues to Kyphon and the hospitals was subject to any negative consequences.  As noted above, it appears that the executives who lead Kyphon at the time it was acquired by Medtronic made substantial amounts of money apparently attributable to this scheme to allegedly "defraud Medicare of hundreds of millions of dollars" (as it was described above in the New York Times). 

Using the public record available on the internet, I tried to see how the top three Kyphon executives are doing now.  It appears they are not doing badly, and remain influential in health care.  According to its 2007 proxy statement, just before Kyphon was bought out, its CEO was Richard W Mott.  As best as I can tell, per Equilar, he currently runs a consulting firm (Walkabout Consulting LLC), and was previously chairman of PhotoThera, which just went out of business.  Kyphon's chief science officer was  Karen D Talmadge, PhD, who is now on the board of directors of the American Diabetes Association, and is also "Chair of the Board of Directors of Gynesonics, and serves on the Boards of Directors of Amplyx Pharmaceuticals, Velocity Pharmaceutical Development and Venous Health Systems."  Kyphon's chief operating officer was Arthur T Taylor, who is now on the board of directors of Providence Medical Technology.

The CEO of Medtronic at the time it bought out Kyphon, and the CEO of HCA at the time the arrangements began appear not to be doing badly either.  The CEO of Medtronic at the time it acquired Kyphon was Arthur D Collins Jr, who is now on the boards of directors of Boeing, Alcoa, and US Bancorp, also, according to his Boeing biography, he is a senior adviser to Oak Hill Capital Partners, and is on the Board of Overseers of the Wharton School.  The CEO of HCA at the time of its arrangement with Kyphon began was Dr Thomas Frist Jr, who is currently on the Forbes list of billionaires at number 262 in the world, with a total worth estimated at $4.3 billion.

Summary

In retrospect, this case allegedly involved arrangements between Kyphon, a device company, and multiple hospitals to increase the revenue of all parties by billing the US government for unnecessary hospitalizations occurring after the use of a device made by Kyphon.  The arrangements appeared to have been particularly lucrative for Kyphon's executives after a larger device company, Medtronic, chose to buy Kyphon. Medtronic ultimately paid a large fine and entered into a corporate integrity agreement nine years after the arrangements began.  Now fourteen years after the arrangements began, at least some of the hospitals involved have also paid fines.  The former Kyphon executives who benefited the most seemingly paid no penalties, nor seemingly did any managers of Medtronic or the hospitals who might have gotten larger compensation because of all the revenue that these arrangements generated.    

So initially, the big losers from this complex dance were the US government, and ultimately US tax payers.  Some patients may have also paid out of pocket for unnecessary services and thus lost money too.  Whether some patients suffered due to adverse effects of unneeded procedures was not clear.  Much later, Medtronic and some of the hospitals involved did pay big fines and thus lost some money.  However, it does not appear that they paid anything like what they made from the original scheme, and their payments were delayed for years.  However, the insiders who personally made a lot of money never apparently paid anything later.  So, this case appears to be a vivid example of how such insiders can walk away with piles of money from the misbehavior of their own corporations, while others pay the price.


Many of those of us of a certain age were brought up on myths that ultimately the good guys win and the bad guys lose.  We would all like to believe that the "arc of the moral universe ... bends toward justice."  History and this recent example suggest that it may not do so without our active intervention. 

In health care, as we have said many times (look here for examples), when bad behavior occurs within a large health care organization, rarely are the insiders who authorized or directed it, and who had the most to gain from the behavior ever made to suffer any negative consequences.  As long as health care leaders have such impunity, expect them to continue to personally profit from unethical behavior.  As a result, expect health care costs to continue to rise as quality and access get worse and worse.

True health care reform.needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

Another Revolving Door Variant: From Academia with Millions in Medtronic Royalties, to the White House, to the Health Care Service Corp

The revolving door spins, and where it will stop, nobody knows...

In October, 2010, we noted questions about how Dr Stephen Ondra got to be a Senior Policy Adviser for the US Department of Veterans Affairs. A veteran who was a neurosurgery professor at Northwestern University, Dr Ondra had received millions of dollars in royalties from device manufacturer Medtronic, whose CEO supported his appointment to the government position  (see this post).  As soon as he was appointed, he publicly opposed a nominee for US Surgeon General who had been critical of the medical device industry, and its financial ties to doctors.

After going to Washington, Dr Ondra apparently also served in the Executive Office of the President, in the White House, but returned to Northwestern University in 2012.  However, he did not stay there for long.

This month, a post on Forbes indicated he is moving on again, and back to the corporate side of health care.

the nation’s fourth-largest health insurance company is naming a key former health advisor to President Obama as its top doctor.

Dr. Stephen Ondra, will become senior vice president and chief medical officer at Health Care Service Corp., the Chicago-based parent company of Blue Cross plans in Illinois, Texas, Oklahoma and New Mexico. The plan has more than 13 million health plan members and is looking to grow even more, announcing last year a proposed partnership with the Blue Cross plan in Montana.

Health Care Service Corp is a mutual insurance company, that is, a company owned by its policy-holders rather than stock holders.  However, that does apparently not make it any more ascetic than a typical for-profit insurance company, at least in terms of generosity towards its top hired executives.  As Crain's Chicago Business reported in 2012,

New federal regulations intended to force health insurers to spend less on administration didn't keep the parent of Blue Cross & Blue Shield of Illinois from paying CEO Patricia Hemingway Hall more than $12.9 million in 2011, a 61 percent raise.

The Health Care Service Corp. chief executive's total compensation last year dwarfed the $8 million she received in 2010, according to a filing with the Illinois Department of Insurance. The 2011 increase was fueled by an $11.8 million bonus, which was 69 percent above her 2010 bonus of $7 million.

Ms. Hall wasn't alone in getting a big raise at Health Care Service, whose insurance business booked net income of more than $1 billion in 2011, for the second straight year.

The 10 highest-paid executives at the Chicago-based mutual company — which operates Blue Cross plans in Illinois and three other states — earned a collective $41.7 million, 65 percent more than the $25.3 million they were paid in 2010.

 If Dr Ondra's new position puts him among the latter group of executives, he too stands to make millions a year. 

So to recap Dr Ondra's career so far, in 2010 he was a medical school professor who had earned millions in royalties from Medtronic.  He then went to top leadership positions in the US Veterans Department and Executive Office of the President.  He returned briefly to Northwestern University, only to leave again for a top executive position in for-profit insurance company Health Care Service Corp, where he is likely to make millions more.

Thus Dr Ondra is our latest interesting example of the "revolving door" phenomenon in health care.  He started as an erstwhile academic physician but with a very major financial relationship with a medical device company.  He then went through the door the first time into the US government, and then a second time from the government to a for-profit insurance company, with just a brief stop-over in academia.

By the way, it appears that all of this is quite legal.  It does again raise questions about whether health care leaders in government with previous relationships with industry might still feel undue sympathy to the interests of industry, as might government leaders who can expect future jobs in industry.

Moreover, this case, like previous cases we have discussed,  indicates how leadership in academic health care, corporate health care, and the government tend to blend together.  Leaders of one type of organization have more and more in common with leaders of the other types of organizations than they do with their lesser ranked colleagues, and certainly than with other health care constituencies.  So the more the revolving door revolves, the more we wonder about the corporatism of health care, about how health care seems to be increasingly run by an amorphous group of academic/ corporate/ government leaders whose loyalties may be more to each other than to academic and professional values, patients' and the public's health, and government of, by and for the people.

Marketers' Systemic Influence over Ostensibly Scholarly, Peer-Reviewed Publications: the Medtronic Infuse BMP-2 Example

On the heels of our discussion of how one pharmaceutical company employed a "publications strategy" to commission and control randomized controlled trials to serve marketing purposes, a US Senate committee has released a report about how a device/ biotechnology company "influenced the content of articles in peer-reviewed scientific publications to present... [its product] in the best possible light."

The report was summarized by the Wall Street Journal,

A report by the Senate Finance Committee based on thousands of documents it subpoenaed from Medtronic Inc raises new questions about the integrity of the medical research underpinning one of the medical-device maker's products.

Medtronic was 'heavily involved in drafting, editing and shaping the content of medical journal articles' about the product—a bone-growth protein used in spine surgery called Infuse—even as it was paying the physicians who wrote those articles a total of $210 million for unrelated work, the Senate report alleges.

In one instance, a Medtronic employee recommended to one of the physicians not publishing a list of side effects associated with Infuse in a 2005 journal article, company emails show. Medtronic marketing officials also urged inserting language into other journal articles touting the use of Infuse as better for patients than using bone harvested from their pelvises because of the pain associated with the latter, other company documents show.

Medtronic's influence extended to preparing a physician's 2002 speech to a panel advising the Food and Drug Administration on whether to approve the drug, the report alleges. The physician's disclosure to the panel at the time suggested his testimony was independent, but the company had in fact helped him draft it and paid him as a consultant the previous year, company documents show. Medtronic later hired the physician as an executive.

In response to the Senate report, Medtronic issued a statement saying it 'vigorously' disagreed with any suggestion that 'it improperly influenced or authored any of the peer-reviewed published manuscripts.' The company also denied that it 'intended to under-report adverse events' associated with Infuse.

The Extent of the Problem

The report itself is available here. It is worth discussing some of its sections about how the company is alleged to have influenced the peer-reviewed, scholarly clinical literature in more detail.

First, it asserted that "Medtronic employees, including employees working for its marketing department, collaborated with physician authors, many of whom had significant financial relationships with Medtronic, to draft" 11 specific articles in the literature published between 2002 and 2009.

Obfuscating Adverse Effects

The report provided detail about specific instances in which Medtronic employees appeared to influence publication to further marketing objectives.  The first was apparently to cloud discussion of adverse effects of its product [italics added for emphasis]:

documents indicate that a Medtronic employee involved in editing a draft of the 2005 Journal of Bone and Joint Surgery (JBJS) article by Burkus, et al. about a similar InFuse procedure involving allograft bone (a cage made from donated bone rather than the FDA-approved titanium), recommended that 'significant detail' concerning adverse event  data should not be published.

On June 16, 2004, Dr. Julie Bearcroft, Director of Technology Management in Medtronic’s Biologics Marketing Department, wrote an e-mail to other Medtronic employees, commenting on a draft of the study, 'I have made some significant changes to this document (some at the request of Dr. Burkus) both in format and content.  In this e-mail, she asked: 'How much information should we provide relative to adverse events? . . . You will see my [note] in the attached document but I don’t think significant detail on this section is warranted.'  The referenced note in the draft article stated: 'I don’t believe we want to report in the same manner as we do in IDE studies. I personally think it is appropriate to simply report the adverse events were equivalent in the two groups without the detail.' According to an internal e-mail, the adverse events were observed in the trial and formatted in a detailed table. But following the advice of Bearcroft, this table of adverse events was not included in the published paper.

On July 3, 2004, after Medtronic edited the paper, Dr. Burkus sent a draft to his co-authors writing that 'this manuscript documents the superiority in clinical and radiographic outcomes with the use of rhBMP2 in a study population of only 133 patients.'

According to the Carragee et al. Spine Journal article published in 2011, the 2005 JBJS article 'reported no complications, such as end-plate fracture, collapse, and implant migration associated with rhBMP–2 despite the clear radiographic findings in at least the one presented case.  The e-mail exchange indicates that, in addition to Medtronic editing the manuscript without attribution, the company was recommending that the article omit a complete accounting of adverse event data, including serious adverse event data that were already considered a documented concern by FDA in similar application.
 
These types of adverse events were disclosed in Table V of a 2009 follow-up article concerning the original IDE study. Studies published in 2007 revealed that InFuse is associated with 'a clinically important early inflammatory and osteoclastic effect of the rhBMP–2 in soft tissue and bone, respectively.  In other words, Medtronic recommended against including information in the study that was ultimately revealed to have an association between In-Fuse and weakening that could lead to collapse of the bone and implant and required that patients undergo additional surgery.

Note that in this example, someone explicitly associated with marketing apparently edited a draft of a scholarly article, suggested that detail about adverse effects of the company's product be omitted, and that the published article in fact omitted such detail.

The report also included an example in which another Medtronic employee apparently tried to "tone down" the discussion of adverse effects of the product, but did so too late to influence the published version. 

Emphasizing the Adverse Effects of an Alternative to Using the Company's Product

On the other hand, the report also included an example in which it alleged that a company employee suggested adding emphasis to the drawbacks of using a management strategy that did not include use of the company's product.

Documents show that Medtronic edited draft publications to stress the pain patients experienced from undergoing a bone graft procedure instead of receiving InFuse. Medtronic markets InFuse as a less painful alternative to bone graft procedures for patients undergoing spinal fusion surgery.

In particular,

After receiving a draft of an early InFuse study 52 to review in October 2001, Medtronic’s Neil Beals, whose 'primary job responsibility was to manage Biologics marketing programs and initiatives,'  recommended that the physician authors of the study emphasize pain experienced by patients who received the bone graft. The patients were divided into an investigative group that received InFuse and a control group that received a bone graft obtained from the iliac crest of their pelvis.  An October 31, 2001 e-mail shows that Beals suggested to Dr. Burkus that 'a bigger deal should be made of elimination of donor site pain with INFUSE . . . so that ‘equivalent’ results aren’t received as a let down.'   Again, after reviewing a later draft of the study, Beals asked Dr. Burkus on March 8, 2002, 'would it be appropriate to make a bigger deal out of donor site pain and include more discussion and references?  Subsequently, a sentence was inserted at the end of a later draft, and included in the published version of the article, that read, 'The use of rhBMP–2 is associated with high fusion rates without the need for harvesting bone graft from the iliac crest and exposing the patient to the adverse effects associated with that procedure.'

Medtronic also sought to include discussion of long-term pain in the Baskin, et. al. 2003 paper on InFuse in the cervical spine. In a draft of the publication that was being circulated on August 30, 2002, the authors wrote, '[b]y 12 months after surgery, the patients [sic] graft-site pain had resolved . . . and no patients complained about the graft-site appearance.'  Beals inserted comments after this sentence stating, 'ALTHOUGH THE PATIENTS DID NOT COMPLAIN ABOUT APPEARANCE DIDN’T SOME STILL EXPERIENCE PAIN AT THE DONOR SITE? SEEMS LIKE RESIDUAL EFFECTS OF DONOR SITE SHOULD BE NOTED.  [sic] [emphasis in original]. In an e-mail to his colleague, Beals wrote, 'I would also add in more discussion on donor site pain and need for osteogenetic graft material (plant seed of doubt for just using allograft by itself ).  A review of the final published article reveals that, after Beals made the suggestion to emphasize pain at the bone graft site, a sentence was added in the final version of the article that read,  '. . . even at the 24-month follow-up assessment, some patients continued to experience residual pain at the donor site, and rated the appearance of the site as only fair.'

Note that in these two examples, another marketing employee edited drafts of two scholarly articles, suggested that more emphasis be put on supposed adverse effects of the procedure that the articles compared to the procedure which used the company's product, and that the two articles included such emphasis. 

Deceptive Response to Peer Reviewers' Criticisms of Apparent Bias 

Finally, the report included an instance in which a company employee managed correspondence between an article's ostensible first author and journal editors to try to defend wording which reviewers had criticized for bias in favor of the company's product.

In summary,

E-mail exchanges between Dr. Burkus and Medtronic employees regarding a study of InFuse utilizing the posterior lumbar interbody fusion (PLIF) technique and published in The Spine Journal in 2004 demonstrates that Medtronic employees not only edited the draft manuscript to include comments supportive of InFuse,  they also covertly participated in the peer-review process by drafting responses to peer-reviewers on behalf of the physician authors named on the paper.

In particular, one employee, Rick Treharne, previously identified as "Senior Vice President of Clinical and Regulatory Affairs," wrote a very positive summary statement for the article's discussion section:

In a January 10, 2003, e-mail to Dr. Burkus, Rick Treharne wrote, 'In looking over the data, I was impressed with how well the BMP patients actually did. So much so that I added a few paragraphs at the end that you may not agree with.' 

However, the reviewers were skeptical,

One reviewer wrote: 'Unless the authors can discuss the results of this study in an unbiased manner, which they have been unable to do in its present form, this data should not be published.'  Another reviewer wrote: 'The manuscript is full of biased statements that are a reflection of the data evaluators—the company that markets the product.'  That reviewer recommended a discussion of potential bias in the text of the paper writing,  'As it stands it is an advertisement for a specific product without significant scientific merit.'

Then, Medtronic employees then took over the process of responding to this review, to wit,

E-mail correspondence on May 28, 2003, indicates that Medtronic’s Rick Treharne wrote and sent Dr. Burkus a draft letter to Dr. Tom Mayer, Editor-in-Chief of The Spine Journal, to address concerns raised by orthopedic surgeons tasked with peer-reviewing the submitted PLIF paper. A subsequent e-mail by Julie Bearcroft notes that she and Dr. Burkus collaborated further on the response to the peer-reviewers of this study during a Lumbar Spine Study Group event.

In response to the peer-reviewers’ concerns about bias in the manuscript, the response letter seemingly misled The Spine Journal by stating that 'To help eliminate any potential bias, only one of the co-authors was a clinical investigator—the other three were independent reviewers of all the data. Since these data are taken from a clinical IDE study sponsored by a company, only the company would have all the data in its database—data that is reviewed by FDA auditors. We don’t believe any discussion of bias is needed for the text.'  By the end of 2003, 'independent reviewers' Dr. Haid and Dr. Burkus would have received $7,793,000 and $722,000 from Medtronic, respectively. This draft letter, written at least in part by Medtronic on behalf of Dr. Burkus, did not disclose the company’s role in directly editing the paper nor did it disclose the magnitude of financial payments made to the supposed 'independent reviewers.'

Thus, in this case, a marketing employee apparently edited a draft of a scholarly article to exaggerate benefits of the company's product, directly adding text to the article, and when peer-reviewers suggested that the article showed bias towards the company's product, apparently two employees ghost-wrote a response letter that claimed that certain authors were "independent reviewers," obfuscating that they had previously received large payments from the company.

Summary

In 2010, we noted reporting that suggested Medtronic had paid huge amounts, millions of dollars, to spine surgeons for reasons that were not clear.  Later that year, we noted further reporting that surgeons who were getting amounts sometimes exceeding one million dollars from Medtronic were not disclosing these payments in scholarly articles about the company's BMP-2 product.

Now there appears a US Senate committee report alleging that Medtronic marketing employees systematically influenced the writing, editing, and publication of multiple ostensibly scholarly articles, ostensibly written by doctors, to favor the Medtronic In-Fuse BMP-2 product.  This adds to previous case studies suggesting that pharmaceutical, biotechnology, device and probably other kinds of company marketers may try to systematically manipulate the design, implementation, analysis, and dissemination of supposedly scholarly and unbiased clinical research to more effectively market their products and services.  

This is discouraging to a former full-time academic physician who now realizes that the difficulties I encountered getting my manuscripts published, given that they written entirely by academic investigators and uninfluenced by marketers, may have been due to the cacophony of competition from marketing influenced texts professionally promoted to journals to serve vested interests.

This is more discouraging to a proponent of evidence-based medicine who believes that medical decisions ought to be informed by critical review of clinical research obtained by systematic search in order to weigh the benefits and harms of management options,accounting for patients' values.  When that clinical research was being deliberately influenced and biased by people selling goods and services, it is not clear that even rigorous critical review will distill the truth from the injected bias.  Yet if physicians cannot depend on published research to guide their decision making for individual patients, what can they depend on?

I conclude as I did my last post,...   Thus health care professionals, policy makers, researchers, and the interested public need to be even more skeptical about arguments made to promote innovative treatments and other clinical interventions.  However, it is not clear that even rigorous skepticism can defend the integrity of evidence based medicine from marketing disguised as clinical research.

Going forward, we must consider erecting an impregnable barrier between clinical research and those whose primary interest is to make money by selling health care goods and services.  If we do not do that, we will forever need to worry that we really have no idea what "works in medicine," and whether any particular test, treatment, or program provides benefits that outweigh its harms.