On the Interconnectedness of the Leadership of Health Care Organizations: the Abbott Laboratories Case

We just posted about some misbehavior by Abbott Laboratories: a physician Abbott paid as a "key opinion leader" to help market its cardiac stents was accused of inserting stents in many patients who had no need for them; Abbott settled for over $400 million a lawsuit alleging the company defrauded Medicare and Medicaid; and it settled an unrelated suit for over $40 million alleging the company paid kickbacks to physicians for prescribing its drugs.  I thus thought it would be interesting to see how well paid are the corporate leaders who presided over these activities, and who are the board members who were supposed to be providing stewardship of this company.

According to the company's 2010 proxy statement, the five highest-paid executives were:

Miles D White, Chairman of the Board and CEO - $26,213,966 total compensation
Thomans C Freyman, Executive Vice President, Finance, and CFO - $9,561,227
Olivier Bohuon, Executive Vice President, Abbott Pharmaceutica Group - $5,232,589
Laura J Schumacher, Executive Vice President, General Counsel, and Secretary - $5,724,060
James V Mazzo, Senior Vice President, Abbott Medical Optics - $10,394,085

Now, let us turn to the company's board of directors.  Note that I looked for board members who also held leadership positions in other health care organizations whose interests may not be aligned with the corporation.  I also looked for those who held leadership positions in the discredited financial services corporation who helped usher in the global financial collapse.  (I  used similar methodolgy here.)

Abbott currently has 12 board members, including

• Robert J Alpert MD - Ensign Professor of Medicine, Professor of Internal Medicine, and Dean of the Yale School of Medicine.  He also "serves as a Director on the Board of Yale-New Haven Hospital."
• Roxanne S Austin - President and Chief Executive Officer, Move Networks Inc, and President, Austin Investment Advisors
• William M Daley -"Vice Chairman and Head of the Office of Corporate Responsibility and Chairman of the Midwest, JP Morgan Chase & Co."  He is the board of directors of  "Loyola University of Chicago and Northwestern University."
• W James Farrell - Retired Chairman and Chief Executive Officer of Illinois Tool Works Inc
• H Laurence Fuller - Retired Co-Chairman of BP Amoco, former chief executive officer of Amoco
• William A Osborne - Retired Chairman and Chief Executive Officer of Northern Trust Corporation and the Northern Trust Company.  He is "Chairman of the Board of Trustees of Northwestern University."
• Rt Honorable Lord Owen - Chairman of Europe Steel Ltd
• Roy S Roberts - Managing Director, Reliant Equity Investors.
• Samuel C Scott III - Retired Chairman,  President and Chief Executive Officer of Corn Products International.  He "currently serves on the board of directors of Bank of New York Mellon Corporation."  He also is on the board of "Northwestern Healthcare."
• William D Smithburg - Retired Chairman, President and Chief Executive Officer of Quaker Oats Company.  He is on the "board of trustees of Northwestern University."
• Glenn F Tilton - Chairman, President and Chief Executive Officer of UAL Corporation and United Airlines Inc.  He is on the "board of directors of Northwestern Memorial Hospital."
• Miles D White - Chairman of the Board and Chief Executive Officer, Abbott Laboratories, "is on the board of trustees of "Northwestern University." 

Of Abbott's 12 directors, seven have leadership positions at teaching hospitals, academic medical centers, medical schools or their parent universities (Northwestern University, its medical school and teaching hospitals, in particular, are stewarded by six Abbott directors). 

Two have leadership positions in  financial services corporations that were implicated in the global financial collapse.  (Note that JP Morgan Chase staffers helped to invent some of the kinds of financial derivatives widely viewed as causative of the collapse, but the firm itself did not fail. [See Tett G. Fool's Gold.]  Through TARP, the US government took preferred equity stakes in both JP Morgan Chase and Bank of New York Mellon.  [See Ritholtz B.  Bailout Nation. p. 222]) 

Two more are leaders of financial services firms.  All but one are current or former high-level hired executives (seven are or were CEOs), or chairpersons or co-chair persons of corporations (the one exception is a dean of a medical school.) 

Note how similar our findings were here to those found after our perusal of the boards of Genzyme and Medtronic (see post here).   So we find again that executives of health care organizations who preside over various questionable activities not only rarely pay any penalty, but usually become extremely wealthy in the process.

We also find how interconnected is the leadership of health care.  The boards and leadership of drug and device companies overlap with the boards and leadership of medical schools, teaching hospitals, and their parent universities. 

Yet, as we have noted before, there are obvious conflicts.  In particular, teaching hospitals and medical schools are supposed to provide unbiased teaching, including about issues relevant to drug and device corporations, such as choice of diagnostic strategies and treatments, and relevant health policy.  They are supposed to perform unbiased research, including research that evaluates drugs and devices.  They are supposed to provide the best possible patient care at a reasonable cost, which relates to choices of and prices paid for drugs and devices. 

On the other hand, drug and device companies are supposed to put making a profit for their share-holders first.  The directors of such companies, like the directors of all for-profit corporations, are supposed to show an unyielding loyalty to their companies' financial health and profits, although contemporary corporate directors have been accused of acting more like cronies of the hired management.  (See this post.)

Also, we note that the vast majority of people chosen as stewards of a given health care organization are current or former top hired executives of other corporations.  The board members, that is, stewards of health care organizations, to whom the top hired executives reports, are usually not people with large ownership interests in the organizations (in the case of public, for-profit corporations.)  For the most part, they also do not seem to be people with clearly demonstrated devotion to the values of health care, in particular, putting the care of individual patients first, and advancing health care teaching and research.  Instead, they seem to be people with the perspective of hired executives, who may be prone to putting the interests of hired executives, rather than patients, doctors, teachers, scientists or the public at large, first.

So here is another admittedly limited case study of the board of directors, that is, the ostensible stewards of a health care corporation, selected this time because of its history of ethical missteps, which showed  - that the leadership of health care organizations is incredibly interrelated, interlocked, incestuous.  Again, it appears that top leaders of various health care organizations may be more familiar with and identify more with each other, and with other hired executives and managers, than with their organizations, their organizations' missions, and their organizations' professionals, staff, students, clients, and patients.

So to repeat-

I strongly believe that there needs to be much more investigation, academic, journalistic, and perhaps legal, of the identity, nature, and culture of the leaders of health care, and their relationships. A few bloggers cannot do it all. Obviously, the anechoic effect mitigates against medical and health care academics looking into their own leaders. However, failing to understand who is leading our march to the brink of health care failure ought not to be something such academics would want on their conscience.

Finally, and obviously, health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research.

If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses.

Post Title → On the Interconnectedness of the Leadership of Health Care Organizations: the Abbott Laboratories Case

Abbott Laboratories and Pig Roasts, the "Philly Mob," and Legal Settlements

Help.... The health care muck is now being raked so fast I can't keep up.

Abbott Laboratories, Prolific Stenters, Pig Barbecues, Etc

In the last week, multiple media outlets picked up the story of the cozy relationship between Abbott Laboratories and a doctor now accused of implanting too many cardiac stents for too much money.  The essentials were, as summarized from New York Times, Wall Street Journal, and Baltimore Sun articles -

Dr Mark Midei was a prolific user of cardiac stents for patient with coronary artery disease (blocked cardiac arteries)

In the June deposition, Dr. Midei estimated that in 2005 — before research revealed that many stents were unnecessary — he performed about 800 stent procedures. Instead of dropping in subsequent years, however, the number of stents Dr. Midei inserted rose to as many as 1,200 annually, he estimated. In a 2007 internal document, Abbott Laboratories ranked Dr. Midei’s use of stents behind only five other cardiologists in the Northeast, including those at hospitals four and five times St. Joseph’s size. [NYT]

Therefore, hospitals sought him out

He had been one of the most sought-after clinicians in his region. Trained at Johns Hopkins University, he was a co-founder of MidAtlantic, a practice with dozens of cardiologists that controlled much of the cardiac business in Baltimore’s private hospitals. Dr. Midei was one of the practice’s stars. When MidAtlantic negotiated a $25 million merger with Union Hospital in 2007, the deal was contingent on his continued employment.

St. Joseph was so concerned about losing Dr. Midei’s business that the hospital offered a $1.2 million salary if he would leave MidAtlantic and join the hospital’s staff. [NYT]

However, it appeared he performed the procedures on patients who would not benefit from them.

The hospital engaged a panel of experts who reviewed 1,878 cases from January 2007 to May 2009 and found that 585 patients might have received unnecessary stents.

When asked to review the cases himself, Dr. Midei found far less blockage than he had initially, according to the Maryland Board of Physicians. The hospital suspended his privileges and eventually sent letters to all 585 patients. Hundreds of lawsuits against Dr. Midei and St. Joseph followed, including from patients treated well before January 2007. [NYT]

Nonetheless, Abbott Laboratories had been rewarding him for frequent use of their products

Word quickly reached top executives at Abbott Laboratories that a Baltimore cardiologist, Dr. Mark Midei, had inserted 30 of the company’s cardiac stents in a single day in August 2008, 'which is the biggest day I remember hearing about,' an executive wrote in a celebratory e-mail.

Two days later, an Abbott sales representative spent $2,159 to buy a whole, slow-smoked pig, peach cobbler and other fixings for a barbecue dinner at Dr. Midei’s home, according to a report being released Monday by the Senate. The dinner was just a small part of the millions in salary and perks showered on Dr. Midei for putting more stents in more patients than almost any other cardiologist in Baltimore. [NYT]

When his over-use was alleged, Abbott continued to use him as a key opinion leader.

Abbott responded to the controversy by hiring Dr. Midei as a consultant. 'It’s the right thing to do because he helped us so many times over the years,' an Abbott executive wrote in a January e-mail cited in the Senate report. [NYT]

Also,

After St. Joseph barred Dr. Midei from practicing there in May 2009, Abbott arranged consultant work for him, according to emails released by the Senate committee.

In December 2009, an Abbott senior vice president wrote in an email that he was 'very open' to having Dr. Midei do consulting 'to see how it might go—either getting the word out in China/Japan, medical or safety work.'

The following month, the Sun reported on the allegations against Dr. Midei and St. Joseph. According to the Senate report, an Abbott executive subsequently said in an internal company email, 'We recommend that we not use Dr. Midei in the U.S. at this time (the press is just too hot).'

Charles Simonton, the medical director of Abbott's vascular division, said in another email cited by the report that Dr. Midei should 'clearly avoid' the Baltimore area, but Dr. Simonton encouraged colleagues to 'please find key physicians or cath labs you'd like him to get in front of with our data.' Abbott wanted to hire Dr. Midei 'because he helped us so many times over the years,' yet another Abbott executive said in an email.

Dr. Simonton didn't return phone calls seeking comment.

Abbott sent Dr. Midei to Japan to promote the Xience stent, but bad publicity caused that trip to be cut short in late January, the report says. In total, Abbott paid the doctor $30,623 to help market the Xience, the Senate investigators found. [WSJ]

When the relationship was criticized, Abbott executives responded with threats, or were they jokes?

I called David Pacitti, vice president of global marketing for Abbott Laboratories' cardiac-plumbing division, to ask why he seems to want goons to beat me up in the newspaper parking lot.

'Don't you have connections in Baltimore?????' Pacitti e-mailed a subordinate regarding a January column I wrote on heart-artery stents. 'Someone needs to take this writer outside and kick his ass! Do I need to send in the Philly mob?'

Pacitti and other Abbott execs apparently don't care for suggestions that their expensive vascular devices often do patients little good and that a star Baltimore doctor took their encouragement to be 'truly outstanding' a bit too much to heart. [Sun]

Furthermore,

Pacitti didn't return my phone calls, but an Abbott flack got in touch on Monday.

'We sincerely apologize if this caused you any concern or distress,' the company spokesman said. Pacitti's comment, he said, 'wasn't meant to be taken seriously.'

Yeah, that's what King Henry II said after they whacked Thomas Becket. [Sun]

So here is a particularly vivid case showing how big health care corporations make "key opinion leaders" out of doctors apparently just because they use or prescribe a lot of the company's products, regardless of the doctors' expertise, or ethics.  As we noted before, "key opinion leaders" are seen by corporate marketing executives as fellow travelers or useful idiots (see posts here, and here). It again appears is that all that health care corporate marketers care about is selling product. Whether their pitches are honest or ethical is besides the point. Those who get in their way are treated with contempt, and maybe, just maybe are threatened with violence

The physicians who are flattered at being called "key opinion leaders," or "thought leaders" have got to realize that the marketers think they are chumps. If they think they are providing honest information, or education, they are deluded.

This case has already been widely discussed in the blogsphere.  See, in particular, posts by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog, and Larry Husten on the CardioBrief blog.

But if that were not enough, on the heels of this story came several more about Abbott Laboratories

Abbott Laboratories Settles, Twice

As reported by the Los Angeles Times, while Abbott was trying to hide Dr Midei overseas, it was also busily negotiating settlements of completely separate charges:

Abbott Laboratories and two other pharmaceutical firms agreed to pay more than $421 million to settle claims of defrauding Medicare and Medicaid in the latest in a string of nine- and ten-figure health care fraud settlements announced by the Justice Department.

The drug companies charged one set of prices to doctors and pharmacies but reported another set of inflated figures that were used as benchmarks by government insurers reimbursing health care providers. The spread, or difference, amounted to kickbacks to the companies' customers, according to Tony West, assistant attorney general for the Justice Department's civil division, who announced the settlements on Tuesday.

In particular,

Abbott, of North Chicago, Ill, agreed to pay $126.5 million to settle accusations that it charged the government inflated prices for products ranging from sterile water and saline solution to vancomycin, an antibiotic.

An Abbott spokesman said the company believes 'that we have complied with all laws and regulations' and settled the case to avoid 'the uncertainty associated with continued litigation.'

At least he did not threaten the Department of Justice officials with an attack by the "Philly mob."

But that is not all. The Wall Street Journal reported that Abbott had to make a second, unrelated settlement:

Separately on Tuesday, the Justice Department announced an unrelated $41 million settlement with Abbott subsidiary Kos Pharmaceuticals Inc. on charges that it paid kickbacks to doctors and other health professionals to encourage them to prescribe or recommend the cholesterol drugs Advicor and Niaspan.

As part of that settlement, Kos entered into an agreement that will allow it to avoid prosecution on criminal charges. 'These actions occurred prior to Abbott's acquisition of Kos in 2006 and Abbott has not been accused of any wrongdoing,' an Abbott spokesman said.

However, Abbott chose to acquire a company that allegedly chose to pay kickbacks of this sort. The apparent resemblance to Abbott's payments to Dr Midei in the case above are striking.

By the way, the Los Angeles Times article also noted previous black marks on Abbott's record:

Abbott also paid $614 million in civil and criminal penalties in 2003 to end a federal investigation of the company's marketing practices and Medicaid and Medicare reimbursements.

In 2001, TAP Pharmaceutical Products Inc., of Lake Forest, Ill., an Abbott joint venture, agreed to pay $875 million and plead guilty to a criminal charge of conspiring with doctors to overbill Medicare.

At the time, the TAP penalty was the largest health care fraud settlement in U.S. history, but it has since been eclipsed by at least two others.

So we once again illustrate how punishing wrong doing by fining large corporations, when the fines are just seen as a cost of doing business, in the absence ofany negative consequences on the real people who authorized, directed, or implemented the bad behavior fails to deter future bad behavior.

This remarkable confluence of cases suggest how rotten are the ethical foundations of even large and previously respected health care organizations. I imagine, though, that as long as these corporations richly reward their executives regardless of the ethics of their actions, and regardless of the long term effects on the organizations' reputations, and as long as their are no externally imposed negative consequences on these leaders, the practices will continue, and will get worse.

Health care costs keep rising, access keeps declining, quality gets worse. We moan and wring our hands, but as long as we allow the rot to worsen, and the muck to grow, expect these trends to continue until the whole smelly mess collapses of its own weight (with all those rich executives escaping to their mansions.)

If we really want high quality accessible, reasonably priced health care, we need true health care reform that reduces concentration of power in large organizations, and makes health care organizations' leadership accountable, ethical, and transparent. That will not be easy.

ADDENDUM (8 December, 2010) - See also comments by Maggie Mahar on the HealthBeat blog, David Williams on the Health Business Blog, and Paul Thacker on the Project on Government Oversight blog.

Post Title → Abbott Laboratories and Pig Roasts, the "Philly Mob," and Legal Settlements

Abbott Laboratories Settles

Another day, another settlement, this time,as reported by Reuters:

New York Attorney General Andrew Cuomo said Abbott Laboratories (ABT.N) and French drugmaker Fournier have agreed to pay $22.5 million to settle a multistate lawsuit that accused them of conspiring to block generic forms of their TriCor treatment for triglycerides.

The drugmakers will pay the money to New York, 22 other states and the District of Columbia, Cuomo said in a news release on Thursday. About $4.5 million goes to New York.

The lawsuit, filed in Delaware federal court in March 2008, alleged Abbott and Fournier schemed to block generics when competitors started to develop versions of TriCor, used to treat a type of blood fat that increases the risk of heart disease.

Cuomo said Abbott and Fournier made minor changes to TriCor that provided no clinical benefit, but were meant to prevent pharmacists from dispensing less-expensive generic versions of TriCor.

The states alleged the drugmakers also thwarted generic competition by filing baseless patent-infringement suits against generic drugmakers, thereby securing a monopoly for blockbuster TriCor.

The ongoing march of legal settlements of charges of various kinds of wrongdoing by diverse health care organizations is a reminder of the pervasiveness of bad conduct by such organizations. We have commented repeatedly (see some posts here) such settlements, including the "corporate integrity agreements" now frequently attached to them, seem to have done little to deter bad behavior. Usually, the companies involved only need to pay fines, and no individual who performed, directed or approved unethical or illegal acts will suffer any negative consequences. I submit once again that such fines are viewed merely as costs of doing business by the affected companies, and do not deter future bad behavior.

While each new entry in the ongoing march of settlements merits a few lines in the business media,separately, or in the aggregate these settlements rarely get noticed by health services or health policy research, or receive attention in health policy circles.  Nor do the contrasts between the conduct revealed by such settlements and the rosy public relations of the settling companies attract much attention.  For example, Abbott Laboratories proclaims its "promise,"

We are here for the people we serve in their pursuit of healthy lives. This has been the way of Abbott for more than a century - passionately and thoughtfully translating science into lasting contributions to health.

Our products encircle life, from newborns to aging adults, from nutrition and diagnostics through medical care and pharmaceutical therapy.

Caring is central to the work we do and defines our responsibility to those we serve:

We advance leading-edge science and technologies that hold the potential for significant improvements to health and to the practice of health care.

We value our diversity - that of our products, technologies, markets and people - and believe that diverse perspectives combined with shared goals inspire new ideas and better ways of addressing changing health needs.

We focus on exceptional performance, a hallmark of Abbott people - worldwide - demanding of ourselves and each other because our work impacts people's lives.

We strive to earn the trust of those we serve by committing to the highest standards of quality, excellence in personal relationships, and behavior characterized by honesty, fairness and integrity.

We sustain success - for our business and the people we serve - by staying true to key tenets upon which our company was founded over a century ago: innovative care and a desire to make a meaningful difference in all that we do.

The promise of our company is in the promise that our work holds for health and life.

The settlement of allegations about a scheme to maintain a monopoly on a profitable drug raise doubts about the company's committment to "earn the trust of those we serve" through "behavior characterized by honesty, fairness and integrity."  Whether the disconnect between this settlement and the "Abbott Promise" will affect the stratospheric earnings of Abbott executives (for example, in 2008, the total compensation of Abbott CEO Miles D White was $28,335,494 per the company's 2009 proxy statement) is a question that could be put to the company's Board of Directors.  Perhaps our readers at Yale University might want to ask Dr Robert J Alpern, Dean of the Yale  School of Medicine, who just joined the Abbott Board of Directors in 2008 about that.

Post Title → Abbott Laboratories Settles

An Original Excuse

The Associated Press just published a story about another company which apparently failed to report adverse events associated with its product:

Complaints about a contact lens solution linked to a 2007 outbreak of eye infections that blinded several people went unreported by the manufacturer for more than a year, government documents show.

The documents show Advanced Medical Optics received complaints about the solution more than a year before it was recalled, and failed to promptly report nine complaints as required by law.

The company pulled its Complete MoisturePlus off the market in May 2007 after the Centers for Disease Control and Prevention linked the fluid to dozens of cases of a serious infection called Acanthamoeba keratitis.

Lawyers for customers suing AMO obtained the documents, which stem from a previously undisclosed inspection by the Food and Drug Administration, through a Freedom of Information Act request. The papers were obtained by The Associated Press.

Of roughly 70 plaintiffs suing AMO and represented by the law firm Schmidt LLP, three had eyes removed, three others suffered blindness and about two dozen had at least one corneal transplant. The others suffered permanent vision damage.

Beginning in February 2006 and continuing through November, AMO received a series of complaints about users who were diagnosed with the Acanthamoeba infections. But those reports were not disclosed until June 2007, when FDA inspectors came to investigate the company's headquarters following its product recall.

What is most striking is the company's rationale for not reporting:

When questioned by FDA inspectors, company officials said they were not obligated to report the complaints because the product's labeling does not say it protects against Acanthamoeba, according to the FDA documents.

Kelly Morrison, a spokeswoman for Abbott Laboratories, which acquired AMO in February, said the company 'believed it was reporting customer complaints in compliance with FDA regulations.' She declined to elaborate. Abbott Laboratories is based in North Chicago.

That is an original excuse. Did the "company officials" really mean to imply that in the absence of a promise to protect against a specific microbiologic organism, patients and physicians should assume that the product could be contaminated with that organism? This completely ignores the company's basic responsibility to supply a product that is uncontaminated with any harmful organisms, and unadulterated with any harmful substances, and hence to be vigilant for any events that suggest that the product could have been contaminated or adulterated.

The "company officials'" bizarre excuse suggest a fundamental lack of comprehension of their responsibilities for the health and safety of the patients using their products. This is a particularly weird example of how little many leaders of health care organizations understand about health care.

Post Title → An Original Excuse

BLOGSCAN - Direct-to-Consumer Device Advertising on YouTube Sans Adverse Effects Information

On the PostScript blog, the Prescription Project announced the discovery of direct-to-consumer marketing videos released on YouTube by three device companies. The video from Abbott advertised the XIENCE-V drug eluting stent. That from Medtronic advertised the Prestige cervical disc. That from Stryker advertised its Cormet hip resurfacing technology. Apparently none of these brave new advertisements bothered to put in the discussion about adverse effects mandated by the US Food and Drug Administration (FDA). The new media obviously presents new opportunities for marketing, including marketing that gets around rules usually applied in other media. Kudos to the Prescription Project for blowing the whistle on this one.

According to this post, soon after the three companies pulled these ads. The issue of new media DTC advertising produced quite a bit of internet buzz. Amazingly, among those agreeing with the Prescription Project's position was none other than Mr Peter Pitts of the DrugWonks blog, the Center for Medicine in the Public Interest, and the Manning, Selvage and Lee public relations firm.

Post Title → BLOGSCAN - Direct-to-Consumer Device Advertising on YouTube Sans Adverse Effects Information

The "Suits" Win Again: How the "Big, Bad, Greedy Pharmaceutical Company" Used One Drug to Hike Another's Price

Here is a little more enlightenment about why the price of health care is so awfully high, from the Wall Street Journal, the example of how Abbott Laboratories elevated the price of Kaletra.

First, let me provide some background. Protease inhibitors revolutionized the treatment of HIV infection. Norvir (rinoavir), manufactured by Abbott, is a protease inhibitor that became popular as part of combination therapy with other drugs for HIV, but was not used alone. Kaletra was introduced by Abbott in 2000 as a single pill that combined Norvir with another protease inhibitor, lopinavir. But in 2003, Kaletra began losing sales to the combination of a new Bristol-Myers-Squibb drug, Reyataz (atazanavir), with Norvir.

In the fall of 2003, Abbott Laboratories grew worried about new competition to its flagship AIDS drug, Kaletra. Then it seized on an unusual weapon that helped Kaletra's global sales top $1 billion a year, even as it exposed Abbott to criticism that it was endangering patients.

The weapon was an older Abbott AIDS drug called Norvir. It is a key part of drug regimens that include rival companies' pills. Previously undisclosed documents and emails reviewed by The Wall Street Journal show how Abbott executives discussed ways to diminish the attraction of Norvir, with the goal of forcing patients to drop the rival drugs and turn to Kaletra.

Norvir represents a twist in which a company took advantage of its monopoly over one drug to protect sales of another, more profitable one.

As Reyataz began gaining market share, Abbott executives considered ways to protect Kaletra sales. On Sept. 6, 2003, Jeffrey Devlin, Abbott's HIV marketing director, emailed a slide presentation to a colleague that discussed two options: quintupling Norvir's price, or withdrawing Norvir pills from the U.S. market and leaving only the liquid version of the drug.

The pill withdrawal option would dramatically improve Kaletra's sales and cripple Reyataz, the presentation predicted, because the drug regimen that included Reyataz would suddenly become more expensive. It forecast that U.S. sales of Kaletra would grow by 20% to 30% between 2004 and 2006, while U.S. prescriptions of Reyataz would fall by 28% to 54% over the same period under the scenario. Anticipating that people would wonder why the Norvir pills were suddenly unavailable, the document recommended telling the American public that they needed to be sent 'to the developing world (i.e. Africa)' as part of a humanitarian effort.
But Mr. Devlin fretted that forcing Americans to swallow Norvir in liquid form 'will always be a tough sell.' Abbott was keenly aware of the liquid's unpleasant taste. In a deposition the following year with investigators from the Illinois attorney general's office, John Leonard, Abbott's vice president of global pharmaceutical research and development, referred to liquid Norvir as 'this fluid that has been -- I'll just say it -- characterized as tasting like someone else's vomit.'

A slide presentation titled 'HIV Communications Plan' and dated Sept. 24, 2003, reviewed the two options and added a third: pulling all formulations of Norvir from the global market. This radical step, the presentation said, would remove 'pricing from public debate' and render moot any discussion of the liquid's taste. However, it noted that Abbott's 'corporate reputation' would suffer.

As for the price-increase scenario, the document listed as a 'Pro' that health insurers might stop covering Norvir, which would hurt sales of other protease inhibitors and force patients to use Kaletra. Among the cons, it cautioned that the move would 'tarnish' Abbott Chief Executive Officer Miles White's debut as chairman of the Pharmaceutical Research and Manufacturers of America, the industry's trade group, and 'position' Abbott as a 'big, bad, greedy pharmaceutical company.'

In early October, as a second new protease inhibitor from GlaxoSmithKline PLC neared FDA approval, another internal document recommended the price increase.

Abbott declined to make Messrs. Devlin, Leonard and White available for comment. Ms. Brotz, the Abbott spokeswoman, says Mr. White, who remains chief executive, didn't know that lower-ranking executives discussed forcing Americans to take Norvir as a liquid or ending its sale altogether. She says the executives were just brainstorming and quickly discarded some of the options. These executives weren't decision makers, she adds.

However, in a court brief filed in the California case last year opposing a plaintiffs' motion to unseal the documents, Abbott said they were prepared by and for some of the most senior officers at the company as part of an enormously important strategic discussion about Norvir.'

In December 2003, Abbott implemented its final decision: a 400% price increase. Norvir's U.S. wholesale price rose to $257.10 from $51.30 for 30 100-milligram capsules. The move made Kaletra a cheaper option for American AIDS patients. It raised the cost of using a Reyataz/Norvir regimen by $2,504 to $11,187 a year. In the case of regimens requiring more than once-daily Norvir boosting, the cost rose by $5,000 or more a year. Kaletra at the time cost about $7,000 a year.

In May 2004, the National Institutes of Health held a public hearing to consider a request by a consumer advocacy group that it authorize cheaper generic copies of Norvir to be made before the drug's patent expired. The NIH has legal authority to do that in cases where it has helped fund research into a drug, but it has never used this power.

John Erickson, a former Abbott scientist who did much of the research work on Norvir, spoke in favor of the request. He testified that it was unlikely Abbott would have funded Norvir's early development without a $3.5 million grant it received from the NIH in 1988. Abbott doesn't dispute the grant was important but says it also invested its own money in HIV research, including $300 million on clinical trials of Norvir. The NIH decided in Abbott's favor, saying it wasn't empowered to determine whether a drug's price was too high.

Over time, the outcry faded. Private health insurers took a bigger blow but had little leverage, because they could hardly deny patients a lifesaving drug. Insurer Aetna Inc. sued Abbott but dropped the suit within days. Abbott also settled a suit brought by the AIDS Healthcare Foundation.

Illinois Attorney General Lisa Madigan has been investigating Abbott's price hike for three years, saying it may be an example of unfair pricing that violates the state's consumer-fraud law. A lawsuit filed in U.S. district court in Oakland, Calif., by two AIDS patients and the Service Employees International Union Health and Welfare Fund alleges that Abbott broke antitrust law by using its market power to boost Kaletra sales. The case is scheduled to go to trial in early 2008.

This would not be the first case in which a pharmaceutical company tried to leverage the price of one product on another. For example, see this post on how Pfizer meant to maintain the price of Lipitor once it went off patent, by combining it with its new drug to boost HDL (good) cholesterol, torcetaprib, a scheme that fell apart after the latter drug proved to have more adverse effects than expected. However, if nothing else, in my humble opinion, Abbott certainly did look like a "big, bad, greedy pharmaceutical company" in the current case.

The most remarkable aspect of this case was how little opposition Abbott's tactics inspired. First, where were the government agencies that are so quick to slash physician reimbursement every time the overall cost of health care goes up?

Actually, it appeared that Abbott cut the federal government a special deal.

Abbott exempted Medicaid, Medicare and state AIDS drug-assistance programs from the price increase. It also announced that it would expand its own patient-assistance program. This enabled the company to argue that the increase was being shouldered by private health insurers, not patients.

Of course, who ultimately ends up paying for health insurance? The people who have it (albeit often indirectly in the US, through foregoing salary that their employers then use to purchase their insurance). In any case, where were the managed care organizations who boast that their goal is to make health care accessible and affordable? And where were the federal enforcers of anti-trust law? Were they were too busy blaming physicians for rising health care costs to take any notice? And maybe the "suits" in managed care and the US government find it easier to go after individual, unorganized, individualistic physicians than the "suits" in pharmaceutical companies? [I salute the Illinois Attorney General for being willing to take action. Maybe she doesn't wear a suit.]

Of course, as long as the "suits" keep playing in their own sand-box together, individual physicians, and more importantly, individual patients will pay the price.

Post Title → The "Suits" Win Again: How the "Big, Bad, Greedy Pharmaceutical Company" Used One Drug to Hike Another's Price

More Things That Go Bump in the Night

From ghoulies and ghosties
And long-leggedy beasties
And things that go bump in the night,
Good Lord, deliver us!

The Wall Street Journal just published an investigative report updating our knowledge about the ghost writing of medical articles. It includes some important new examples of the genre.

• The manuscript of an article in the American Journal of Kidney Diseases, whose first author was ostensibly Alex J Brown was posted on the web-site of medical writer Michael Anello as an example of his work. He had been commissioned by a medical communications company to write the paper on behalf of Abbott Laboratories, which makes Zemplar (paricalcitol), a Vitamin D analog. Anello was not listed as an author of the published article. (Brown AJ. Therapeutic uses of vitamin D analogues. Am J Kidney Dis. 2001 Nov;38(5 Suppl 5):S3-S19.) Brown claims he partially re-wrote Anello's draft, and was responsible for the final version of the article. Anello has since removed the article from his web-site.
• A medical writer paid by GlaxoSmithKline helped draft a manuscript on the safety of acetaminophen versus aspirin and other analgesics for patients with asthma. GSK makes a version of acetaminophen (Panadol) outside the US. The published article stated that the first author "performed the analysis and drafted the paper." (Jenkins C, Costello J, Hodge L. Systematic review of prevalence of aspirin induced asthma and its implications for clinical practice. BMJ 2004;328:434) The lead author said that the "structure of her work was 'suggested' by the company version but she and the other authors did their own analysis." She also denied knowing that the company paid the writer. GSK said the failure to disclose the role of the medical writer was "a lapse on the part of GSK." A rapid response was just (December 13, 2005) appended to the electronic version of the article, stating, "A medical writer assisted in sourcing the papers, summarising their content and reviewing drafts for this review of the literature, but declined to be included as an author. The authors reviewed all papers considered for the analyses. The scientific evaluation of the data and the clinical commentary contained in the review was provided by the authors. The authors have recently been made aware that, without their knowledge, the medical writer's costs had been met by GlaxoSmithKline, but are confident that the information presented in the review was accurate and reflected the authors' personal scientific opinions."

The Wall Street Journal article also recounts some cases that may be familiar to the readers of Health Care Renewal.

• There was the omission by someone at Merck, unbeknownst to the lead author, of pertinent data about adverse events afflicting patients treated with Vioxx from the manuscript of the VIGOR study sent to the New England Journal of Medicine. (See our post here.)
• How the manuscript of the Advantage trial of Vioxx was written in-house by Merck, not by its first author. (See our post here.)
• The "stealth marketing" campaign that included the authoring of multiple articles about Zoloft (sertaline) by a medical education company at Pfizer's behest. (See our post here.)
• The finished draft of a manuscript on the adverse effects of warfarin sent to Dr. Adriane Fugh-Berman by a medical communications company hired by AstraZeneca, which was starting to market a new competing drug, Exanta (ximelagatran). (See our posts here, here and here.)

Kudos to the Wall Street Journal and reporter Anna Wilde Matthews for reminding us that ghost-writing is an ongoing, unsolved problem. It would be fitting to conclude with a quote from the editorial in the Journal of General Internal Medicine that accompanied Dr Fugh-Berman's article noted just above.

Publishing biased literature is not simply "getting the message out" for the pharmaceutical client of the medical education company. It injects bias and untruth into the scientific dialogue in order to enhance corporate profits.
How much is sullying the medical literature worth in market share?

Protect us, indeed!

Post Title → More Things That Go Bump in the Night