"A Kind of Blackmail": A Not-for-Profit Health Insurance Company CEO's Salary So Large It "Had Broken the Law"

Here is another case in the annals of over-paid executives of not-for-profit health care organizations, this time from the Burlington (VT) Free-Press,

Blue Cross and Blue Shield of Vermont overpaid its former chief executive officer by $3 million over an eight-year period and has been ordered to pay the money back to its subscribers by 2012 in the form of reduced premiums, a top state regulator said Wednesday.

The action by the state Banking, Insurance, Securities and Health Care Administration Department follows last year’s disclosure that William Milnes, the nonprofit firm’s former CEO, received a $7.2 million payout when he stepped down in 2008.

Furthermore, note that

[Commissioner of the Banking, Insurance, Securities and Health Care Administration Department Paulette] Thabault said her department had concluded Blue Cross had broken the law by paying Milnes more money than necessary to perform his functions as head of the nonprofit health-benefits provider.

The Department's review found obvious flaws in how Blue Cross Blue Shield set its former CEO's pay:

The department’s review found that Milnes’ salary package while at Blue Cross was excessive, and in some years, he was paid more in bonuses than he received in base pay. In 2005, for example, Milnes was paid $425,000 in salary and $489,800 in bonuses.

'Other health insurance or managed care organizations of a similar size to the Vermont company compensate their chief executive officers at a level of about 45 percent to 50 percent less than the compensation levels set by the company for Mr. Milnes,' the department order said in part.

The department said Blue Cross used a 'peer group' study to justify the pay it gave Milnes, but regulators concluded the study was flawed because it put Milnes’ position on the same level of chief executive officers of much larger Blue Cross sister companies.

'The peer group ... used in 2007 included 14 companies, all but one of which were substantially larger in terms of annual gross premiums,' the department’s order said. 'Nine of the 14 companies had gross premiums in excess of $1 billion.' Blue Cross gross premiums for 2007 were $590 million.

This story is striking because it seems that the overpayment of a not-for-profit health care organization's executive this time seemed to rise to the level of crime. However, current Blue Cross leaders seemed unconcerned.

'The company accepts the findings of the department, and it just wants to move on at this point,' [Blue Cross and Blue Shield spokesman Kevin] Goddard said.

Somehow, whenever a health care organization's conduct is publicly revealed to be shameful, the response is not sorrow or apology, but let's just "move on." Moving on, of course, minimizes the accountability of those initially responsible for the bad behavior.

Furthermore, do not expect corporate leadership to acknowledge anything wrong with how the pay for the top hired corporate executive was determined.

Goddard said the company thought the peer group numbers it was using were sound.

'Our board used a comprehensive analysis to come up with a compensation package for Bill,' he said. 'We relied on what we thought was professional information.'

One begins to feel a little sorry for the poor spokesman who is obligated to mouth these sorts of sentiments. Whether the analysis was rational, or the "professional information" was relevant or correct seems not to have bee anyone's concern.

In addition, although Blue Cross and Blue Shield is now obligated to reimburse its policy-holders for former CEO Milnes' excessive pay, do not expect the money to come out of his pocket:

None of the $3 million the company has to pay back will come from Milnes. Blue Cross asked Milnes, through his attorney, if he would give back some of the money but was rejected, according to documents in the case made public Wednesday.

'He has made it quite clear that Mr. Milnes is not willing to make a voluntary repayment of any portion of the Supplemental Executive Retirement Program distribution,' Christopher Gannon, a Blue Cross vice president, wrote in a letter to Thabault’s department Jan. 21.

One would think that the current company management would be so upset about its new $3 million obligation, that it would aggressively try to recover the money from the person who benefited from it. However, it seems that all the current Blue Cross and Blue Shield management was willing to do was politely requesting that Mr Milnes return it. Suing a former CEO, of course, is just something that is not done. Perhaps it would be too disturbing to  the cozy atmosphere now prevailing among top executives and the boards of trustees who are supposed to be supervising them. This seems to make clear that no one at Blue Cross and Blue Shield ever really was responsible for what Mr Milnes was paid.

As an editorial in the Rutland Herald put it:

On its face, it was an outrage. Blue Cross is a nonprofit corporation that insures about 150,000 Vermonters. That a nonprofit with a mission of providing health care coverage should be a source of extravagant personal profit was an affront to all Vermonters, including those struggling to pay escalating premiums, those struggling to find adequate care, or those with no coverage at all.

The usual excuse from companies is that big money is necessary to attract big talent. It's a marketplace. But this excuse is really a kind of blackmail that allows corporate executives to collude in the inflation of their own worth.

So the notion of the "imperial CEO" who can virtually set his or her own pay, unencumbered by any real accountability to a board of trustees who would dare not ruffle the imperial feathers has now been imported even into relatively small health care organizations in New England states once famed for their common-sense and frugality.

So here we go again.... We have discussed numerous examples of compensation of health care organizations' leadership that seems orders of magnitude above that which would be rationally justified. These latest examples of the wealth being accumulated by leaders of supposedly mission-centered not-for-profit organizations are a product of the current management culture that has been infused into nearly every health care organization in the US. That culture holds that managers are different from you and me. They are entitled to a special share of other people's money. Because of their innate and self-evident brilliance, they are entitled to become rich. This entitlement exists even when the economy, or the financial performance of the specific organization prevents other people from making any economic progress. This entitlement exists even if those other people actually do the work, and ultimately provide the money that sustains the organization.

Although the executives of not-for-profit health care organizations generally make far less than executives of for-profit health care corporations, collectively, hired managers of even not-for-profit health care organizations have become richer and richer at a time when most Americans, including many health professionals, and most primary care physicians, have seen their incomes stagnate or fall. They are less and less restrained by passive, if not crony boards, and more and more unaccountable. In a kind of multi-centric coup d'etat of the hired managers, they have become our new de facto aristocracy.

Or as we wrote in our previous post, executive compensation in health care seems best described as Prof Mintzberg described compensation for finance CEOs, "All this compensation madness is not about markets or talents or incentives, but rather about insiders hijacking established institutions for their personal benefit." As it did in finance, compensation madness is likely to keep the health care bubble inflating until it bursts, with the expected adverse consequences. Meanwhile, I say again, if health care reformers really care about improving access and controlling costs, they will have to have the courage to confront the powerful and self-interested leaders who benefit so well from their previously mission-driven organizations. It is time to reverse the coup d'etat of the hired managers.

Oh, the Prices We Pay, Reloaded - Celgene Balks at Explaining High Price of Thalidomide

A brief article on Bloomberg.com implied that Celgene has been fighting efforts by the Canadian Patented Medicine Prices Review Board to get pricing data about the drug Thalidomid (thalidomide):

Celgene Corp., the biotechnology company specializing in blood-cancer medicines, will get a hearing before Canada’s highest court over the country’s demands to provide pricing information for the drug Thalomid.

The Supreme Court of Canada today agreed to hear Celgene’s appeal of a Federal Court of Appeal ruling that said Canada’s Patented Medicine Prices Review Board was entitled to information about the pricing of the drug. The high court gave no reason for its decision.

Celgene’s two top-selling drugs are Revlimid and Thalomid, for a form of blood-cancer called multiple myeloma. They brought in more than 80 percent of the company’s total $2.25 billion in 2008 revenue.

It should be no surprise that Celgene may be sensitive about the price of Thalidomid. We posted back in 2005 about the stratospheric prices of new drugs that seemed disproportionate to manufacturing and development costs on one hand, and the value of the drugs for patients on the other. We noted that thalidomide, a very old drug that notoriously was found to cause birth defects when it was given to pregnant women, but that then showed promise as an anti-cancer drug, was being marketed in the US for $29 per capsule (approximately $25,000 a year), while a generic form sold in Brazil for $0.07 per capsule.
 
The amount Celgene manages to make from this very old (and demonstrably cheap to produce) molecule is vivid, albeit anecdotal evidence about what has gone wrong with health care prices in the US.  Despite health care insurance companies' protestations that their goal is to provide reasonably priced health care, they seem utterly incapable of negotiating down the prices of even the most obviously over-priced drugs.  And the US government Medicare program so far is prohibited by law from negotiating prices.  How our supposed free market health care system has tilted so far in favor of pharmaceuticals is a reason to wonder, but ought to be reason to investigate. 
 
Meanwhile, Celgene's 2010 annual report shows that the company has sold more than $400 million worth of Thalidomid yearly since 2007. The company's total sales in 2009 were $2.567 billion, while it spent $795 million on research and development, and $754 million on general, sales, and administrative expenses. According to the company's 2009 proxy statement, in 2008 its CEO received over $8.5 million, its COO over $5.1 million, its CFO over $2.1 million in compensation, and a senior vice president over $3.0 million. The total compensation of its five highest-paid hired managers (compare to a total of 2813 full-time employees in 2009), approximately $20.5 million 2008, was was approximately 2.6% of the company's net income in 2009, and just under 1% of its total sales.
 
As we have said previously, so the health care bubble continues to inflate.  One cause is"compensation madness," including "insiders hijacking established institutions for their personal benefit."  Another is the amazing acquiescence of those who pay bills at all levels, from the individuals who ultimately fund health care through salary dollars not earned, health insurance premiums, co-pays and the like, and tax payments, through the health care insurers and government agencies who did not balk at paying $25,000 a year for thalidomide in 2005.  If we really want to provide accessible health care of good quality and a reasonable cost, we will need to develop mechanisms to pay more reasonable amounts for health care goods and services. This will require some courage facing down the corporate and organizational insiders who have made themselves very rich from the current craziness.

With Leaders Like These...

My current favorite book about the global financial meltdown, aka great recession, The Sellout, by Charles Gasparino, featured vivid portraits of the bad leadership that lead to the collapse.  For example:

Richard S Fuld, Jr, former CEO of Lehman Brothers (now bankrupt) -

Fuld had become more isolated and arrogant. (p.208)

As the firm's leverage increased, Fuld's grip on his management and board grew. He was revered by so many people in his circle of senior advisers that almost no one dared to speak out about the firm's risk and leverate, and almost never to Fuld himself. Everyone else was so scared to be cursed at in public or even fired that they simply kept their mouths shut.

Fuld's leadership was more like that of a cult leader than even that of an imperial CEO. (p. 209)

Maurice R ("Hank") Greenberg, former CEO of AIG (now bailed out by the US government) -

Greenberg had begun the financial products group that sold all those [now discredited] credit default swaps in the late 1980s....

Greenberg had a love-hate relationship with the group and its various leaders. He hated the risks they took and the independence the top people in the group sought. But he loved the profits the financial products group ... produced.

Yet Eliot Spitzer, the New York State attorney general and by now Wall Street's most famous enforcer, believed Greenberg ran a company that regularly committed accounting fraud and created fictional profits through a series of sham transactions that had nothing to do with credit default swaps. Greenberg considered these possible transgressions so trivial that he called them 'foot faults,' as in a minor foul in tennis.

Greenberg eventually did resign.... (p. 204)

[and the financial products unit nearly drove AIG bankrupt]

John A Thain, former CEO of Merrill Lynch (bailed out by being forcibly merged into Bank of America under pressure from the US government)

Over time, it became difficult to keep track of every statement coming out of Thain's mouth that turned out to be wrong since nearly the moment he had taken over as CEO. (p. 417)

Thain was becoming unhinged; during a briefing in one of his finely decordated conference rooms that had been part of the $1.2 million office spending spree, people close to the firm said, he completely lost his compusure when an aide informed him about the size of the [company's] losses. What Thain did isn't clear, but Merrill Lynch had to replace a shattered glass panel that appeared to have been the target of the CEO's rage. (p. 419)

- Sanford I Weill, former CEO of Citigroup (bailed out by the US government)

But in reality, Will never really ran anything. He was a visionary, to be sure, but one whose vision was so myopically focused on building the empire had lusted for for so long and on its share price that he ignored just about everything else. (p. 144)

So here we again have reminders of how bad leadership of major US financial firms lead to the collapse. We had discussed a series of such factors and how they obtain in health care, suggesting that health care is undergoing a bubble likely to burst just as badly as did the financial/ housing bubble.

However, I supplied these quotes not just to underline this point.  It turns out that Mr Fuld, Mr Greenberg, Mr Thain, and Mr Weill have something in common other than having helped to lead their financial firms toward the brink, something in common with relevance to health care.

We recently discussed the outsize compensation given to the current CEO and other top leaders of one of the country's revered medical centers, New York - Presbyterian Hospital.   I suggested that such "compensation madness" will continue to inflate the health care bubble.  What that post did not discuss was how these leaders got to be so well paid.  Presumably, their compensation was set, or at least acquiesced to by the Board of Trustees of the hospital.  So I thought it might be entertaining to see who is currently on this Board.

According to the medical center web-site, the Board of Trustees as of October, 2009, was quite large (including 88 people by my count).  The web-site lists only names, not biographies, so that who most of the members are was not obvious.  This lack of transparency, which is not uncommon in health care organizations, would make figuring out who all the people ostensibly responsible for the $9.8 million dollary man are quite laborious.  However, I did recognize a few names immediately.  These were Richard S Fuld, Jr, Maurice R Greenberg, John A Thain, and Sanford I Weill. 

Thus, the Board of Trustees of New York - Presbyterian Hospital includes four of the most well-known architects of the global financial meltdown.  Thus, is it any wonder why the Board of Trustees was happy paying the CEO of a not-for-profit health care institution at a level comparable to a for-profit corporate CEO?  (And is it any wonder that the Dean of the Faculties of Health Sciences and Medicine, and Executive Vice-President for Health and Biomedical Sciences at Columbia University, one of the two medical schools that provide students, trainees and faculty at New York - Presbyterian Hospital, once admitted that the school's main criterion for faculty success was ability to generate external funds, which he called being a "taxpayer," rather than ability to teach, research, or take care of patients?)

As we have discussed before, boards of trustees of not-for-profit health care institutions have a primary duty to uphold the institutions' missions.  Thus, one would think such boards would be selected according to their dedication to their missions.  But perhaps, in the grubby real world, there may be more important criteria, possibly such as the size of their donations to the institution.  Furthermore, those likely to donate the most  may be more likely to be richest (and perhaps most in need to making themselves appear philanthropic and public-spirited) than the most fervent upholders of patient care, teaching and research.

Maybe giving stewardship of our once proud health care institutuions to people most likely to defend their missions, rather than most likely to donate a lot of money, would result in somewhat poorer institutions which do a better job of patient care, teaching and research. 

Teaching Would-be Health Care Leaders About Health Care: Why Is This News?

The Wall Street Journal just published a story on a big innovation in the business school curriculum:

David Song was in the middle of a two-year executive M.B.A. program at University of Chicago's Booth School of Business in February when he got the idea to create a course to help business people better understand the inner workings of medicine.

Dr. Song, chief of plastic surgery at the University of Chicago Medical Center, believes the course may help close the gap between such industries as pharmaceutical and biotech, and the medical community they serve.

'Why not help reveal how things run and how we make decisions, particularly in this time of immense overhaul to the system?' says Dr. Song, who began collaborating with one of his marketing professors, Sanjay Dhar, to put together the course, titled 'Understanding the New Breed of Healthcare Decision Makers'—a five-day $7,650 program slated for May.

The program is designed to give participants a look at the administrative workings of an academic medical center, including how doctors make decisions about the way to treat patients, and which devices and products they choose to purchase.

Booth, like other business schools, is struggling to keep up enrollment in executive education at a time when companies are pulling back on training budgets. Dr. Song's health-care program is the only new addition to the curriculum for the academic year, says Stephen LaCivita, associate dean of executive education.

The program is geared toward professionals who work in areas like pharmaceuticals, medical devices and financial services, who may have a limited understanding of the physicians, nurses and other clinicians who are their customers.

Some of the issues addressed in the seminars, which will be taught by medical and business faculty, include: how doctors and hospitals define value; how reimbursement strategies work; and how supply chain, purchasing decisions, patient flow and operations are managed.

And here is the course's big feature:

As an added bonus, on the second to last day students will change into scrubs and observe a surgery, make rounds with doctors and see how patients are prioritized in the emergency room. 'This is getting a glimpse of what it's like and how we make decisions,' says Dr. Song.

Earlier this year we noted a NY Times article which breathlessly promoted management jobs in health care, partially by implying that they were available to those who knew little to nothing about what health care actually entails, with, at most "a little studying up." This new article suggests how little "studying up" may actually be needed.  The fact that a five-day course to teach budding MBAs a little bit about health care is considered a newsworthy business education innovation by the Wall Street Journal certainly suggests that the prevailing business culture allows management of heatlh care organizations by people with almost no knowledge of or experience in actual health care.

We noted in August that the NY Times article had the whiff of a bubble about to burst.  Indeed, we just noted an article that listed some of the salient characteristics of the recently burst financial/ housing bubble, including "major organizations lead by the clueless."  For that post, we used examples of three leaders of huge financial firms that have now failed (that is, are bankrupt or bailed out) who did not understand the complex derivatives their firms were buying and selling.  In the earlier post, we noted examples of leaders of two big American automobile companies that have now similarly failed who seemed to know little about automobiles.  So here we have would-be leaders in pharmaceutical, medical device and other health care corporations "who may have a limited understanding of the physicians, nurses and other clinicians."

This reinforces my thesis that health care is now in a bubble that will soon burst.  It also suggests why health care in the US costs so much, out of proportion to the quality or access provided.  Even setting aside how the business culture in the last 20 years has put short-term revenue and personal enrichment ahead of everything else, why would we expect that health care leadership by people who know little about health care, and care less for its values, would be anything but disastrous?

The $9.8 Million Dollar Man

We seem to have a new candidate for the award for best-paid CEO of a not-for-profit academic medical center, as reported in the New York Post,

Wall Streeters aren't the only ones raking in big bonuses during tough economic times.

Hospital presidents and CEOs also collect fat bonuses and 'incentive payments,' even as health-care systems cry poverty, claiming they struggle to break even against government cutbacks, tightwad insurers and skyrocketing costs.

While warning of layoffs and slashed patient services, many hospitals shower their top execs and department heads with bonuses and perks. They include housing allowances, chauffeurs, first-class air travel, tuition for their kids and country-club memberships.

Under new IRS rules, the extras are disclosed for the first time in recently filed 2008 tax records obtained by The Post.

The filings for the city's biggest and most prestigious private, tax-exempt hospitals show at least a dozen CEOs get compensation of $1 million and up. Some also cash in early on million-dollar pre-retirement payouts while on the job.

Dr. Herbert Pardes, who runs the New York-Presbyterian Hospital and its health-care system -- the city's largest private hospital network -- received a $1 million bonus in 2008 on top of his $1.67 million salary.

The hospital has a 'pay for performance' philosophy but says even though Pardes met his goals, his bonus was smaller than 2007's to 'reflect the current external environment.'

But Pardes' compensation totaled $9.8 million in 2008 because he vested in a retirement plan that will pay $6.8 million when he leaves in 2011. He also received a $93,500 housing allowance and the use of a car and driver.

The Post article also listed two other hospital CEOs who got over $4.5 million in compensation, and several other top executives at other hospitals who got substantial compensation despite the hospitals' financial distress or accusations of unethical behavior.  On the other hand, the CEO of the city's Health and Hospital Corporation, with a budget of $6.3 million, got only $291,000.

Note that Dr Pardes' total compensation was more than double the compensation for a Boston medical center CEO that I thought was so outlandish back in September, 2009.

So here is much more evidence about the continually inflating health care bubble.  Not only do executives of big, for-profit drug, device, biotechnology and health insurance companies make seven and eight figure salaries, now it appears executives of ostensibly not-for-profit, charitable organizations can also make this much. 

Is it possible that at least Dr Pardes' compensation was a fluke, related to a one-time retirement payment?

The answer appears to be negative.  The New York - Presbyterian Hospital's 2007 US Internal Revenue Service (IRS) form 990, which was organized somewhat differently and may have used somewhat different definitions than the 2008 form from which the Post reporters apprently got their information, showed Dr Pardes total compensation to be $4,736,824 plus a $1,433,761 contribution to employee benefit plans and deferred retirement plans in that year. In addition, in 2007, (apparently former) executive Vice President Michael A Berman, MD received $5,949,092 in compensation plus $31,830, current Executive Vice President and Chief Operating Officer Steven J Corwin MD received $2,671,747 plus $455,304, Senior Vice President and Chief Financial Officer and Treasurer Phillis RF Lantos received $2,481,044 plus $336,284, Senior Vice President and Chief Operating Officer Robert Kelly received $1,538,412 plus $271,641, Senior Vice President and Chief Operating Officer Cynthia N Sparer received $1,370,541 plus $307,259, Senior Vice President and Senior Legal Officer Maxine Fass Esq received $1,337,354 plus $257.06, Senior Vice President, Finance Dov Schwartzben received $1,314,960 plus $173,848, Senior Vice President and Chief Nursing Officer Wilhelmina Manzano received $1,218,966 plus $159,555.  In summary, in 2007, the medical center paid at least 10 current and former executives each substantially more than $1 million a year.

By my calculations, the medical center paid these ten executives over $26 million a year, approximately equal to 25% of the center's fund excess (e.g., profit equivalent), of slightly over$106 million.  These ten executives received nearly 1% of the entire 16,850 employee institution's budget.  Furthermore, note that in the medical center's 2007 expense statement, general and administrative expenses, over $675 million, made up about 24% of the center's total expenses. 

So it appears that gigantic compensation for New York - Presbyterian Hospital executives, which is outsize both in comparison to the Hospital's fund excess and total budget, is part of a long-term trend
The Post quoted Brian Conway of the Greater New York Hospital Association with this excuse:

There are thousands of 20-somethings on Wall Street making millions who don't have anywhere near the responsibilities or skills of New York hospital CEOs.

This fits in our catalog of logical fallacies.  It is an appeal to common practice.  Of course, the particular practice to which Mr Conway appealed is the exaggerated executive compensation in finance that many believe was a cause of the global financial melt-down, aka great recession.  One could also argue that not one Wall Street executive has the life and death responsibilities of the typical practicing primary care physician.  I doubt Mr Conway would try to argue that Dr Pardes' job requires 40 times the skill of full-time practicing primary care or cognitive physician.

Instead, executive compensation for hospital CEOs seems best described as Prof Mintzberg described compensation for finance CEOs, "All this compensation madness is not about markets or talents or incentives, but rather about insiders hijacking established institutions for their personal benefit."  As it did in finance, compensation madness is likely to keep the health care bubble inflating until it bursts, with the expected adverse consequences.  Meanwhile, I say again, if health care reformers really care about improving access and controlling costs, they will have to have the courage to confront the powerful and self-interested leaders who benefit so well from their previously mission-driven organizations. 

More Air Into the Health Care Bubble: the $30,000 a Month Cancer Drug

Over four years ago, we posted about the stratospheric prices of new drugs that seemed disproportionate to manufacturing and development costs on one hand, and the value of the drugs for patients on the other.  For example, back then we noted that thalidomide, a very old drug that notoriously was found to cause birth defects when it was given to preganant women, but that then showed promise as an anti-cancer drug, was being marketed in the US for $29 per capsule (approximately $25,000 a year), while a generic form sold in Brazil for $0.07 per capsule.

That was then, and this is now.  This week, the New York Times reported on a $30,000+  per month cancer drug. 

A newly approved chemotherapy drug will cost about $30,000 a month, a sign that the prices of cancer medicines are continuing to rise despite growing concern about health care costs.

The price of the new drug, called Folotyn, is at least triple that of other drugs that critics have said are too expensive for the benefits they offer to patients. The colon cancer drug Erbitux, for instance, costs $10,000 a month and the drug Avastin about $8,800 when used to treat lung cancer.

So what could be the rationale for this breathtaking price?

Drug Effectiveness

Could it be that the drug is extremely effective? Not according to the NY Times:

Folotyn has not yet shown an effect on longevity. In the clinical trial that led to approval of the drug, 27 percent of the 109 patients experienced a reduction in tumor size. The reductions lasted a median of 9.4 months.

But considering all the patients in the trial, only 12 percent had a reduction in tumor size that lasted for more than 14 weeks. The trial did not compare Folotyn to another drug or a placebo

A PubMed search revealed no sign that this trial had been publsiehd, and no publications reporting any controlled trials of this drug.

So at best, this drug at best may temporarily shrink tumors, although that assertion is based on evidence that has not yet been published or subject to peer-review. It does not seem that the tremendous price of the drug could be justified by tremendous benefits to patients.

Research, Development and Manufacturing

So, perhaps the drug was very difficult and expensive to create, manufacture and develop?  That does not seem to be the case, either.

Folotyn's generic name is pralatrexate. As the name suggests, it is a chemical compound very similar to the much older anti-cancer drug methotrexate. [See O'Connor OA. Pralatrexate: an emerging new agent with activity in T-cell lymphoma. Curr Opin Oncol 2006; 18: 591-597.]  It was first developed not by Allos Therapeutics, but by Memorial Sloan-Kettering Cancer Center, Southern Research Institute, and Stanford Research Institute.  The Allos Therapeutics 2008 annual report noted that the company's total research and development expenses for the drug from 1992 through 2008 were $26.8 million (so much for the urban myth that the average drug costs $1 billion to develop.)  Based on the estimate that the drug would cost roughly $30,000/ month from the NY Times, the company could recover all the development costs of this drug after 893 patient-months of use.

Allos Therapeutics does not actually make pralotrexate, but outsources its production, according to the company's .  The firm's total yearly manufacturing costs (for several experimental drugs as well as pralotrexate) in 2008 were $6.7 million.

So it does not seem that the tremendous price of the drug could be attributed to the costs of discovering, developing, or manufacturing it.

So where would the money go?

General and Administrative Costs, Executive and Board Compensation

Allos Therapeutics seems to spend a disproportionate amount of money on marketing, general and administrative costs.  According to the 2008 report, "marketing, general and administrative expenses include costs for pre-marketing activities, corporate development, executive administration, corporate offices and related infrastructure."  In 2008, these expenses were $23 million, in one year, almost as much as the company spent over 16 years to research and develop Folotyn.

Allos Therapeutics has enriched its corporate insiders.  According to the company's 2009 proxy statement, in 2008, CEO Paul L Berns received $2,091,600 in total compensation; Chief Commercial Officer James V Caruso received $1,259,700; and Chief Medical Officer Pablo J Cagnoni received $1,408,700.  The total compensation of the five highest paid executives of the company in 2008, $5,945,500, was over 10% of the entire company's budget, $53,639,000. 

Mr Berns, who has only been with the company since 2006, owned 994,606 shares or equivalent (at a price of $6.62 per share on 4 December, 2009, worth $6,584,292).  Mr Caruso owned 272,072 shares or equivalent,and Dr Cagnoni owned 386,245.   Although two board members, Stewart Hen and Jonathan S Leff seemed to be serving by virtue of their positions with Warburg Pincus & Co, whose Private Equity VIII LP owns over 29% of Allos Therapeutics stock, Mr Hen and Mr Leff received $120,700 and $119,400 to sit on the board.

These amounts should be considered in light of the fact that the company is comparatively tiny.  Its 2008 report disclosed that it only has 81 full-time employees, of whom fully 31 "are involved in marketing, corporate development, finance, administration, and operations."  The company has never made money.  Its 2008 report noted losses of over $20 million a year in the past five years, and a total loss of over $289 million.

So one wonders if the real reason pralatrexate was priced so high was to justify the millions that top company leaders have reaped from a company that lost money over the 16 years?

Summary

The NY Times reported that people outside of Allos were not pleased with the price of Folotyn:

Dr. Lee N. Newcomer, senior vice president for oncology at the big insurer UnitedHealthcare, called the price of Folotyn 'unconscionable.' He said that Folotyn alone would cost as much as UnitedHealthcare now typically spends in total to treat a lymphoma patient from diagnosis until death. That median expenditure now, he said, is $87,000 for a little over a year of treatments.

But Dr. Newcomer said insurers would be obligated to pay for Folotyn because there were no alternatives.

Furthermore,

'This drug is not a home run,' Dr. Brad S. Kahl, a lymphoma specialist at the University of Wisconsin, said during a meeting of an advisory committee to the F.D.A. on Sept. 2. 'It’s not even a double. It’s a single.'

Saying that even a single was helpful, Dr. Kahl was part of a majority on the panel that recommended approval of the drug, 10 to 4.

But after recently learning what Allos planned to charge for Folotyn, Dr. Kahl said he was 'disappointed' by the 'excessive' price.

'It dampens my enthusiasm for using that drug,' he said. 'It creates these huge ethical quandaries about trying a drug that has a modest benefit for the average patient at enormous expense.'

So the health care bubble continues to inflate.  I suggest that the case of the ridiculous pricing of Folotyn shows how this bubble is in part generated by "compensation madness," not only "insiders hijacking established institutions for their personal benefit," but also insiders able to become rich at the expense of even tiny, money-losing corporations.   But the bubble is also generated by the amazing acquiescence of those who pay bills at all levels, form the individuals who ultimately fund health care through salary dollars not earned, health insurance premiums, co-pays and the like, and tax payments, through the health care insurers and government agencies who did not balk at paying $25,000 a year for thalidomide in 2005, and seemingly will not balk at paying $30,000+ a year for pralatrexate in 2009.

If we really want to provide accessible health care of good quality and a reasonable cost, we will need to develop mechanisms to pay more reasonable amounts for health care goods and services.  This will require some courage facing down the corporate and organizational insiders who have made themselves very rich from the current craziness. 

NOTE (21 December, 2009) - See also comments on the Postscript blog.

The Health Care Bubble: Parallels with the Global Financial Meltdown

The global financial melt-down, or great recession, or whatever it will be called was a big surprise in September, 2008, to those of us not immersed in finance. A year later there is an opportunity to at least better understand the events leading up to it.  I have managed to read two focused books on aspects of the melt-down, (House of Cards, by William D Cohan, and Fool's Gold by Gillian Tett) and am in the midst of what may be the best general narrative of it published to date, The Sellout, by Charles Gasparino.

Reading the recent history of the meltdown makes me uncomfortably aware of parallels between these events and the current dysfunction of the health care system.  In his discussion of the run-up to the crash, Mr Gasparino emphasized a number of issues which I will catalog along with their health care parallels.

Prices Always Go Up

The prices in question were those of real-estate, and the notion that they would always go up helped to fuel would an explosion of mortgage loans made to people who had little chance of fully repaying them.  When housing prices reached an unsustainable level and started to fall, the melt-down began.

-  It is a cliche that overall health care costs in the US have been going up much faster than inflation for as long as most of us can remember (at least since the 1970s), creating the expectation that they always will go up.   

Products were Over-Rated by the Apparent Experts

Mortgages made to people who were unlikely to be able to pay them back were sold by irresponsible originators, and then packaged into financial derivatives by finance firms.  Many of these derivatives were rated "AAA" by trusted rating firms, even though they contained multiple individually risky mortages.  The rating firms boasted of expertise, and used complex mathematical models supposedly based on evidence to make their ratings. 

-  In health care, we have come to trust expert professionals' assessments of products (like drugs and devices) and services based on their expertise and clinical research evidence. 

Evidence Used to Rate Products was Suspect

The mathematical models used to predict risk were based on limited data and assumptions.  In particular, they did not account for the possibility that real-estate prices might go down, or that particular circumstances might cause multiple home-owners to default on their mortgages at the same time.  The increasing level of defaults, signaling that the derivatives based on the mortgages might be riskier and less valuable than previously thought, caused the melt-down to accelerate.

-  We have discussed how the clinical evidence may be manipulated by those with vested interests in selling products or services.  When manipulation  does not yield the result desired by the marketers, the results of the research may be entirely suppressed.  One particularly telling example was the suppression of research  unfavorable to new anti-depressant medications as documented in part by Erick Turner et al.  When all suppressed research was taken into account, the drugs appeared much less effective than was previously believed.

The Experts were Conflicted

The rating agencies were paid by the finance firms which sold the derivatives.  Ratings agencies that did not deliver sufficiently good ratings were likely to lose business.  "By 2005 triple-A ratings were being handed out like candy: underwriters could nearly demand they wanted on a deal and did."

-  We have discussed how physicians and medical academics frequently have conflicts of interest due to their financial ties to pharmaceutical/ biotechnology/ device and other health care companies.  August academic medical institutions have come to depend on money from industry to support research and education.  Distinguished academics are often paid key opinion leaders for drug and device marketers.

Deceptive Marketing

Per The Sellout, "On Wall Street, complexity isn't something to be avoided - it allows smooth-talking salesmen to obscure simple concepts like risk and losses."

- We have written again and again about deceptive marketing practices, how marketing is disguised as medical education, the use of stealth marketing, etc to promote often overpriced tests and treatments that are often less effective and/or more hazardous than they are advertised to be. 

Politicians Pushed Access without Regard to Consequences

US politicians from both parties pushed ever more accessible mortgages for the laudable goal of making better housing available to the less advantaged, but seemed unconcerned about how they would eventually pay back the loans.

-  The driving motivation for most current health care reforms efforts in the US seems to be to provide "access," now redefined as some sort of health insurance, without much attention to the reasons health care has become so inaccessible in the first place.

Major Organizations Lead by the Clueless

The Sellout provided some notable vignettes, including those about Jimmy Cayne, the CEO of Bear Stearns, who did not understand the complex derivatives his firm bought and sold, or the level of risk the firm was assuming; Stan O'Neal, the CEO of Merrill Lynch, whose tenure was "one of the strangest, most volatile, and ultimately most disastrous that Wall Street had ever seen;" and Charles Prince, the CEO of Citigroup, who apparently was a good lawyer, but had "little experience running a business," much less one as complex as Citigroup.

-  We have repeatedly discussed how large health care organizations are now often mismanaged, at times by people with little knowledge of or experience in the health care context.

Overpaid, Isolated, Arrogant, Imperial CEOs

The Sellout provided more notable vignettes.  Jimmy Cayne (see above), was at one point worth more than US $1 billion.  He spent more and more time playing bridge, and less managing his company.  Stan O'Neal (see above), would often vanish to play golf.  The leadership of Richard Fuld, the CEO of Lehman Brothers, "was more like that of a cult leader than even that of an imperial CEO."

-  We have repeatedly discussed how large health care organizations' leaders may be overpaid (some making nearly as much as the leaders of some financial firms before the collapse), arrogant imperial CEOs, some aspiring to be members of the superclass.  One striking example was the former CEO of UnitedHealth, Dr William McGuire, who was once worth more than US $1 billion before it became apparent that some of his fortune was based on back-dated stock options. 

Sycophantic Cronies as "Stewards"

The Sellout discussed how members of the boards of directors of financial firms were mostly chosen by the CEOs they were supposed to supervise.  For example, Jimmy Cayne, who had "a firm grip over his board of directors," noting "my board is my board."

-  We have often discussed poor governance of health care organizations, and specifically how boards of directors or trustees of health care organizations are similarly unlikely to challenge the CEOs they are supposed to supervise.  We also have noted how health care organizations' are often lead by the same Masters of the Universe who brought us the global financial collapse.  For example, Cornell's Weill Medical School was named after former trustee Sanford Weill, who constructed the giant conglomerate Citegroup, but did not figure out how to make its pieces fit together, and was forced "to step down as CEO as the research scandal [investigation] initiated by [former New York state Attorney General] Spitzer snared its highest-profile target, Weill himself." (from The Sellout, p. 187.)

Suppression of Dissent

The Sellout noted how increasingly arrogant leaders of financial firms ignored advice of more conservative or risk-adverse employees.  Dissenters were often afraid to speak out, and some were fired.  For example, at Bear Stearns, Jimmy Cayne increasingly marginalized "Ace" Greenberg, who was wary of excess risk.  At Lehman Brothers, the cult of personality that surrounded Fuld suppressed dissent and debate.

-  We have discussed the anechoic effect, the lack of discussion surrounding important health care issues, seemingly enabled by the sense that one simply does not talk about such issues.  Whistle-blowers are often ostracized, or worse, and academic freedom and free speech may be frankly threatened.

Ineffective, or Captured Regulators

From the 1980s onward, deregulation of the financial industry advanced.  The Sellout discussed how the Federal Reserve, lead by Allan Greenspan, enabled if not cheer-lead for the bubble.  The  Securities and Exchange Commission (SEC) was often ineffectual at best.

-  We have discussed how the FDA got conflicted advice and often seemed to feel that drug and device manufacturers, rather than the public were its clients.  We just noted that one version of health care reform would put control of a comparative effectiveness research institute in the hands of industry, and would empower its leaders to suppress research which offends them.

Summary

We have discussed the impetus to make physicians give up their professionalism ostensibly to increase competition (see post here), and to then hand over control of health care to managers ostensibly to reduce costs.  Since the 1980s, health care has increasingly been dominated by large organizations run as businesses by business managers.  It should therefore be no surprise that the ethos of health care management has come to resemble the ethos of business management in general.  Thus, maybe the parallels between some of the issues related to the global financial meltdown and the issues related to current health care dysfunction should not be surprising.

A few other bloggers and business writers have referred to a health care bubble in the last few years.  Notably, Dr Wes advanced the concept in 2008.  Dr Rich spoke out in early 2009, and Dr George Lundberg added to it later in 2009. 

So I make a fearless assertion and prediction.  Health care dysfunction has lead to a health care bubble, which is likely to burst soon with considerable adverse consequences.  Perhaps a controlled deflation of the bubble would be possible, but would require more courage and clear thinking than most of our political and health care leaders have exhibited so far.  We have repeatedly noted how current efforts to reform health care have ignored most of the issues discussed above and documented repeatedly on Health Care Renewal.  If one of the currently proposed versions of health care reform becomes law, it may postpone for a while the popping of the bubble.  However, the longer the bubble grows, the nastier the bursting of it.

Do not say we did not warn you.