BLOGSCAN - FDA Panels Violate New Conflict of Interest Rules

On PharmaLot, Ed Silverman noted how the US Food and Drug Administration (FDA) seemed to violate its own new increasingly stringent rules about conflicts of interest when it set up two advisory panels which will be meeting today.

"Happy Accidents" in pharma doubtful: Tax Break Used by Drug Makers Failed to Add Jobs

When the healthcare group of a technology company, Comdisco, Inc., where I worked for a short time folded in early 2000 due to the company's failed fiber/telecom/dot-com investments, I was provided with the services of a local "employee outplacement" firm as part of the severance package. Many of the others in my "cohort" at the local outplacement firm office had been pharmaceutical executives and mid-level managers who'd just been laid off from Centocor, after acquisition by pharma giant J&J.

I noted that these people looked quite shell shocked and depressed, as many were middle-aged and likely had mortgages and kids in college. I was the "odd man out", having come from a non-pharma. The services of the Employee Outplacement company were not very useful, but I did get some hints as to how to improve my resume.

I found a middle-management position at Merck within five months and thought I was set for life, as Merck had a 100+ year history substantially free of major involuntary layoffs.

I was wrong, because within three and a half years, give or take, I was handed a layoff notice along with 4,400 other people. I was sent to another employee outplacement firm (which proved equally un-useful), where I again observed shell shocked and depressed ex-pharma employees. My repeated attempts to "get back in" were unsuccessful. Layoffs and "restructuring" continue at the company, and at about every other large pharmaceutical company as well.

The New York Times posted an article entitled "Tax Break Used by Drug Makers Failed to Add Jobs" by Alex Berenson. The issue is that recent tax breaks given large corporations through a "tax amnesty" on foreign profits in order to add jobs were simply not used to add jobs.

New York Times
July 24, 2007
Tax Break Used by Drug Makers Failed to Add Jobs
By ALEX BERENSON

Two years ago, when companies received a big tax break to bring home their offshore profits, the president and Congress justified it as a one-time tax amnesty that would create American jobs.

Drug makers were the biggest beneficiaries of the amnesty program, repatriating about $100 billion in foreign profits and paying only minimal taxes. But the companies did not create many jobs in return. Instead, since 2005 the American drug industry has laid off tens of thousands of workers in this country.

And now drug companies are once again using complex strategies, many of them demonstrably legal, to shelter billions of dollars in profits in international tax havens, according to their financial statements and independent tax experts.

I am not going to go into detail about the tax amnesty, shelters and strategies here - you can read the article - but it's clear "human resources" (a dehumanizating term that as a physician I frankly abhor) comes second in this industry to other "resources."

Drug makers are not the only American multinationals using tax loopholes to declare large portions of their income beyond the reach of the Internal Revenue Service. The Brookings Institution estimates that multinational companies are using overseas tax shelters to lower their payments to the Treasury by about $50 billion a year. But the drug industry accounts for one of the biggest portions of that shortfall, according to the I.R.S. and independent tax experts.

And the nature of their business gives drug makers techniques, like sheltering valuable pharmaceutical patents in tax-friendly havens like Ireland, that many other industries cannot use. Moreover, the sheer heft of the American drug industry, which had about $60 billion in pretax profits last year, can give disproportionate weight to the economic impact of its tax sheltering techniques.

At least this phenomenon is not limited to the pharmaceutical industry, but that is no excuse for practices that the New York Times article describes. As an example:

... Lilly said in a statement that it complied with the law in taking advantage of the 2005 tax amnesty, which enabled the company to avoid more than $2.3 billion in American taxes. Lilly said it believed that the 2005 tax break had encouraged investment in the United States, noting that the company, which is based in Indianapolis, has invested $1.3 billion in the state of Indiana alone. [invested in what, I ask? Not people -ed.]

Still, since the beginning of 2005, Lilly has cut its United States work force by more than 8 percent, reducing it to 22,000 jobs by last January ... Pfizer, Merck and Amgen declined requests for comment.

In theory, companies are only deferring taxes on the profits they shelter overseas, not permanently avoiding tax. If they bring the money back to the United States to distribute to their shareholders, they still have to pay American taxes on it. But those rules were temporarily suspended when President Bush signed legislation in 2004 to let companies return overseas profits at a rate of 5.25 percent, far below the official tax rate of 35 percent, if they moved the money back by 2006.

During that period, multinational companies of all stripes moved a total of about $300 billion into the United States, avoiding about $90 billion in taxes. Among them, the pharmaceutical industry was the largest single beneficiary. Leading the pack was Pfizer, the world’s largest drug company, which repatriated $36 billion.

The quid pro quo was supposed to be that the drug industry would invest some of its tax windfall in American operations and jobs. Instead, struggling with a dearth of new blockbuster drugs, they have had mass layoffs. Again, Pfizer has been the leader, reducing its work force by about 8,000 in 2006 and saying early this year that it would lay off an additional 10,000 employees.

Indeed, there's this news just on the wires:

J&J to cut 3-4 pct of work force in restructuring
Tuesday July 31, 8:55 am ET

NEW YORK (Reuters) - Johnson & Johnson (NYSE:JNJ - News) on Tuesday announced plans to eliminate 3 percent to 4 percent of its global work force of about 120,500 people as part of an effort to improve its cost structure.

The diversified health care company, whose shares rose nearly 2 percent in premarket trade, said it expected the cost cuts to generate pretax savings of $1.3 billion to $1.6 billion in 2008.

J&J plans to seek savings from its pharmaceuticals division, becoming the latest large drug maker to restructure in response to patent expirations to major products.

That's 4,000-5,000 people. Considering the previously mentioned massive tax breaks on overseas profits, this is not the ethics one would like to see from corporate pharma. Now, it is a company's prerogative to hire and fire as they see fit. However, what the companies are missing is the human toll on both those laid off and those remaining.

In case any corporate execs are reading this posting, let me remind them of what happens after a layoff:

• The stress of losing a job is like the stress of a death in the family or a divorce.
• It involves loss of wages and benefits, role as worker and provider, dignity and self esteem, loss of the "American Dream", loss of trust, loss of control over your life, loss of the pattern of daily life, and loss of the "work family. "
  
• The laid off employees feel resentment, betrayal, hostility, denial, depression, and other emotions that certainly do not endear them to their former employers. They may speak or act negatively against their former companies in numerous venues, no matter how well-written the severance agreement (if they elected to sign one, which basically is a gag agreement that says we'll give you a severance if you stay silent.)
• Many of these employees carry corporate wisdom with them that is lost; and many may carry proprietary knowledge that they share with others, including later employers, no matter how "secure" is the confidentiality agreement. You cannot keep track of everyone all of the time.
• Many employees are forced to sell homes, relocate, pull children out of school, face humiliation in front of their families, and go out hat in hand for new jobs.
• Going out for new jobs carries traumas in and of itself, especially when one is confronted by arrogant and insensitive hiring managers, such as the Sr. VP of Biometrics at a CRO, himself recently laid off from Novartis and rehired by the CRO, who told me "there was nothing in my resume of value to a CRO", the former FDA drug safety official who told me "we don't need medical informatics here", and other minor (e.g., never hearing back after an interview) and major (insults such as above) humiliations that in a bar might earn a person a black eye.
• Remaining employees become overworked, burned out, extremely unhappy and put in a position of fear and uncertainty (I live near my former employer and repeatedly hear this about them in places where the information is likely to be accurate: my local barber shop, my family medicine physician's office, and my car dealer).

To make matters still worse, company management and Human Resources "Catberts" still tout themselves in its hiring ads and eRecruiting sites with puffery that might have been true in past decades, i.e., we are a wonderful place to work and a great place for a career.

Catbert is a typical cat, in the sense that he looks cute but he doesn't care if you live or die. As Human Resources Director at Dilbert's company, he teases employees before downsizing them.

An example of this might be GlaxoSmithKline, where as I understand it from former employees, during a downsizing people are required to justify their position and/or "bid on their own job" in a competitive fashion. If they fail and cannot then "find another position in the company" (after losing your own job that you may have had for years, what's the likelihood that will happen?), then it's out the door. IMO that is simply horrible management of those "precious" "human resources." What could be more humiliating than bidding on your own job?

But all the while, of course, the companies are committed to advancing peoples' careers and curing the ill ... scanning the "career site" web pages of major pharmas, I find statements like this:

We recognize that people are the cornerstone of Pfizer's success, we value our diversity as a source of strength, and we are proud of Pfizer's history of treating people with respect and dignity ... We play an active role in making every country and community in which we operate a better place to live and work, knowing that the ongoing vitality of our host nations and local communities has a direct impact on the long-term health of our business.

And this:

When people notice your hard work and achievements, the satisfaction is hard to contain—and that rings as true on a corporate level as to an individual. That’s why Merck is justifiably proud of our reputation as an organization and employer. The wonderful thing about working here is being part of an exceptional team that not only makes strides in global health, but also in diversity, corporate responsibility and quality.

... At Merck, we’ve received many awards and accolades from industry experts and business partners—for diversity, business ethics and philanthropy. So, if being successful and making an impact matters to you, you’ll be in like-minded company here ... Consistent with our desire to maintain a creative environment that will stimulate individuals to achieve their potential, we take pride in the programs and resources that we offer our employees to help them achieve professional growth, career development and advancement.

The people who actually write this copy must understand the shallowness of their words.

Employees who read this rhetoric fall into one of two groups: those who believe it, and thus are deluded, and those who don’t believe it, and thus may easily become demoralized and cynical.

Environments of the deluded, demoralized and cynical are not the best for leading-edge drug R&D in the opinion of this author. Pharma R&D as in any sophisticated industry is primarily a complex social endeavor. Although many excuses can be offered for making employees feel they are "short timers", expecting high levels of creativity when little heed is paid to human nature is, quite frankly, ludicrous. The culture itself has become sick.

The need for creativity has been observed by others:

Philadelphia Inquirer, July 30, 2007, book review (reviewed by Jen A. Miller):

"Happy Accidents, Serendipity in Modern Medical Breakthroughs" By Morton Meyers, Arcade. 408 pp.

... The biggest breakthroughs in medical history weren't discoveries found on a preordained track but the blessings of "the muse of serendipity." "The heroes of the stories told in this book ... are not scientists who merely plodded rationally from point A to point B, but rather those who came upon X in the course of looking for Y, and saw its potential usefulness, in some cases to a field other than their own."

Consider some of the most groundbreaking, and lifesaving, medical discoveries that were Eureka moments - the X found on the path toward Y: X-rays, penicillin, chemotherapy drugs, and treatments for syphilis, schizophrenia, depression, lymphoma, leukemia, tuberculosis, ulcers and erectile dysfunction. These medical breakthroughs were all found by people looking for something else, usually by people Meyers calls "mavericks" - scientists, doctors, researchers and sometimes even amateurs not at the center of their respective fields of study.

I believe demoralization is not conducive to serendipity. Serendipity, "happy accidents", and "eureka moments" generally require a clear mind. Today's research environments are more likely conducive to nervous breakdowns, not "happy accidents" and serendipitous discovery.

... Meyers also takes an abrupt turn at the book's conclusion. Through most of Happy Accidents, the tone is light and almost funny, but Meyers then makes a vicious attack - not entirely without merit - on the current state of medical research and the pharmaceutical industry ... [Meyers] points out that the pharmaceutical industry, which spends $4.2 billion a year in direct-to-consumer advertising (those "ask your doctor" commercials), isn't helping.

Instead of investing in finding new drugs for conditions that need treating, it instead focuses on "me too" and lifestyle drugs, making slight variations of ones that already exist and still work ... Of the ten top-selling drugs in the world, half offer almost no benefit over drugs marketed previously."

The environment for more "happy accidents" looks grim, at least in the United States.

Indeed.

-- SS

BLOGSCAN - Maggie Mahar on the Provenge Mess

On the Health Care Blog is a post by Maggie Mahar about the Provenge mess. We had most recently posted about it here. A good quote, "in a money-driven health care system, those who view health care as a profit center strive to dictate social policy. "

Hip Protectors and Conflicts of Interest

Associated Press reported Lindsey Tanner just wrote a story (here, via the Washington Post) about undisclosed conflicts of interest affecting authors of an article about the use of hip protectors to ward off fractures in the most recent JAMA (Kiel DP, Magaziner J, Zimmerman S, Ball L, Barton BA, Brown KM et al. Efficacy of a hip protector to prevent hip fracture in nursing home residents: the HIP PRO randomized controlled trial. JAMA 2007; 298: 413-422.)

A new study showing that padded hip protectors didn't prevent fractures in the elderly has renewed questions about hidden drug industry ties to medical research.

Three of the authors of the study on bone breaks didn't tell editors of an influential medical journal, which is publishing their research Wednesday, that they had consulted for or received research money from the makers of bone-strengthening drugs. That potential conflict was discovered by The Associated Press.

Editors of the Journal of the American Medical Association _ which has tough rules on financial disclosure _ had asked the authors about any conflicts and were told there were none. The researchers said later they didn't believe their industry connections were relevant because the study of hip fractures didn't involve bone drugs and didn't recommend them.

The editor of JAMA agrees. Dr. Catherine DeAngelis said that in this case, the drug company connections didn't violate the journal's detailed financial disclosure policy.

DeAngelis said she believes her journal is being unfairly scrutinized by The AP, which found the researchers' ties to drug companies through searches on the Internet and through a consumer database.

'This has nothing to do with drugs,' she said. 'At what point do you say, come on, is this a witch hunt?'

A close reading of JAMA's guidelines suggests the fracture study authors' ties to drug makers are 'clearly relevant,' said Dr. Michael Callaham, president of the World Association of Medical Editors. 'It's a slam dunk,' he said.

A consumer advocate with the Center for Science in the Public Interest agrees. Readers could easily interpret the study to say that since hip protectors don't work, 'I guess I better take the drugs,' even if that's not what the authors intended, said Merrill Goozner. The consumer advocacy group runs a database on scientists' financial ties, an effort to combat corporate influence on science.

In this case, reporting such ties 'seems to me to be a no-brainer,' Goozner said.

[Study author Dr. Douglas Kiel, a Harvard Medical School researcher] ... said bone-building drugs could be one of several options to hip protectors for older patients, but that they are not ideal for nursing home residents because they take a year or more to work and these patients often are already taking many other drugs. But he also said the drug company money he and his colleagues have received is not relevant to the current study because it wasn't a comparison of both treatments.

'We have no financial disclosures with hip protectors,' Kiel said. 'We were asked repeatedly by the editors whether we were following JAMA's full disclosures and we said yes.'

We have previously noted in discussions of ghost-writing and stealth marketing (e.g., here) that pharmaceutical and other health care companies may make elaborate marketing efforts to position their products. These efforts may include attempts to make the problem for which the product is intended seem more prevalent or more serious, and to make other ways to treat the problem look less effective, more harmful, or otherwise less advantageous. Thus it is easy to see how a study showing that hip protectors do not protect against hip fractures might be useful to those seeking to market drugs meant to protect against fractures.

Thus, in my humble opinion, the authors of such a study should have disclosed any financial entanglements they had with companies making such drugs.

Once again, this case illustrates the enormously tangled web of conflicts of interest that now pervades health care. As I just wrote, each one of these conflicts, no matter how financially advantageous for the parties immediately involved, has the potential to negatively affect health care for the broad population, by raising costs, impeding access, or degrading quality. It is not too late to address this member of the herd of elephants in health care's living room.

Naming a University Teaching Hospital for a Pharmaceutical Company

We recently posted (here and here) about the controversy that erupted after the leadership of the University of Iowa proposed naming their new school of public health after a local for-profit insurance company in exchange for a substantial gift from the company's associated foundation. The ensuing newspaper coverage noted that there seems to be no precedent for naming an educational instution after a corporation (as opposed to naming one for an individual donor).

One of our astute readers, however, found this amazing example. The main pediatrics teaching hospital for the University of Medicine and Dentistry of New Jersey (UMDNJ) - Robert Wood Johnson Medical School is the Bristol-Myers Squibb Children's Hospital, named, of course, for Bristol-Myers Squibb, the large pharmaceutical company.. The hospital was apparently well supported by grants from the the Bristol Myers Squibb Foundation.

The hospital opened in 2001. As best as I can tell from a Lexis-Nexis search, there was not the slightest controversy about naming a hospital for a large pharmaceutical company. Obviously, doctors and faculty at the hospital may choose to use Bristol Myers Squibb products, and to perform research, consult, or give talks for the company. Yet there was no public discussion about whether having the hospital named for the drug company produced even the appearance of an institutional conflict of interest.

The naming of the hospital occurred at a time when, in retrospect, the leadership of UMDNJ proved to be quite troubled. The university now is operating under a federal deferred prosecution agreement under the supervision of a federal monitor (see most recent posts here, here, here, here and here.) We had previously discussed allegations that UMDNJ had offered no-bid contracts, at times requiring no work, to the politically connected; had paid for lobbyists and made political contributions, even though UMDNJ is a state institution; and seemed to be run by political bosses rather than health care professionals. (See posts here, and here, with links to previous posts.) A recent development (see post here with links to previous posts) was that UMDNJ apparently gave paid part-time faculty positions to some community cardiologists in exchange for their referrals to the University's cardiac surgery program, but not in exchange for any major academic responsibilities. Another was some amazingly wasteful decisions by UMDNJ managers leading to spending millions of dollars for real-estate that now stands vacant (see post here). Another was the indictment of a powerful NJ politician for getting a no-work job in the system, and the indictment of the former dean of the university's osteopathic medicine school for giving him the job (see post here).

The decision to name the hospital for the drug company was made before the federal deferred prosecution agreement was put in place. One wonders if the ongoing investigation of the previous regime at UMDNJ may cover how it ended up naming a hospital for a drug company. Since the hospital is part of a state institution, one also wonders if naming the hospital violated any conflict of interest policies or regulations.

The decision to name the hospital also took place in 2001, before the pervasive nature of conflicts of interest in health care started receiving some attention. I wonder how many other glaring examples of such conflicts we would find if we only had the time to look more into the modern history of health care.

But each one of these conflicts, no matter how financially advantageous for the parties immediately involved, has the potential to negatively affect health care for the broad population, by raising costs, impeding access, or degrading quality. It is not too late to address this member of the herd of elephants in health care's living room.

ADDENDUM (31 July, 2007) - Please see the comment below from Ed Silverman of PharmaLot, which contains the text of a 1999 Newark Star-Ledger editorial which criticizes the naming of the hospital for a drug company as "commercialism."

BLOGSCAN - When Scientists Disagree with Managers: "You Want Democracy? Go to Russia"

On the Hooked: Ethics, Medicine, and Pharma Blog, Howard Brody discusses how Wyeth's chief of research and development responds to any disagreements by his scientists, "It's not a democracy. You want democracy? Go to Russia." Leaving aside the global political issues, he went on to say that the big question is "whether rigid scientific mindsets will be a barrier to further productivity gains at drug companies less interested in top-to-bottom transformation than Wyeth." Brody's key question: "How far can you shoehorn science into a business-productivity model, before science has been turned on its head completely into marketing and PR?"

Intel's former CEO, EHR's for his horses, and Equus asinus

(Warning: animal-related metaphor alert!)

At this post I lamented the bull-in-a-china-shop intrusion into the domain of clinical IT by Big Business, focusing on Intel Chairman Craig Barrett's ill-conceived "prescription" for healthcare.

I thought I'd seen all the bull regarding such prescriptions.

However, in perhaps the most asinine [no pun intended] metaphor ever used in the domain of healthcare IT, Intel's former CEO Craig Barrett believes his use of EHR's for his 45 members of Equus caballus prove that EHR's for the 300 million or so members of Homo sapiens in the U.S. (and countless billions elsewhere) should be as easy as apple pie ...

... and that the magic bullet of "demands for change" from big employers will miraculously solve the myriad technical, emerging legal, and the nearly intractable sociotechnical, problems that have plagued clinical IT for the past several decades - and that have shown little sign of letting up, even in national-scale projects with massive budgets even larger than Mr. Barrett's wallet.

Intel Chief Repeats Call for Employers to Demand Change
By Neil Versel

July 24, 2007 | How dysfunctional is American healthcare? Craig Barrett, the well-heeled chairman and former chief executive of Intel has electronic medical records for the 45 horses on his Montana ranch, and even veterinary test results via e-mail for his equine friends. But the humans close to him have no such technology.

“I wish the average U.S. citizen had the same response my horses did,” Barrett said during an Intel-sponsored Webcast on chronic care management from Washington, D.C., last week.

... As Barrett has done many times before, he voiced his belief that change most likely will come from big business outside the healthcare sector. (See “Intel, Wal-Mart Call for Employer Activism in Demanding Health IT Adoption.”) “Systems only change rapidly when the people with the buying power demand the change" [i.e., threaten with economic bludgeoning -- ed.], the Intel executive said.

Horse manure is what I say.

When profoundly absurd comparisons of horse EHR's and human EHR's are made by people who apparently believe the size of their wallet trumps their lack of knowledge of issues that make human EHR's such a difficult endeavor, experts who do know better think of a different species:

Equus asinus.

Mr. Barrett, you are not helping healthcare with harebrained comparisons like this. In fact, through technologic determinism and suggestions of a generous application of economic bludgeoning, you are in my opinion making the situation worse, and postponing the day when there will be trusted, national, interoperable EHR's.

Of course, you ran a company that produced widgets, and probably dismiss the "soft issue" sociotechnical domain as fluff - issues that can be resolved through enough money, management consultants, TQM, process re-engineering, six sigma, balanced scorecards, and when all else fails, brute force. I'd be happy to let you take my course Sociotechnical Issues in Healthcare Informatics, but I doubt you'd want to; after all, your expertise in management and in the microprocessor business surely makes you a clinical computing expert.

I have some additional "soft issue" advice for you, Mr. Barrett. Perhaps you should not be bragging about your 45 horses on your Montana ranch. To cash-strapped hospitals that cannot afford EMR at the prices the health IT industry charges (e.g., Temple University in Philadelphia serving a large minority area of the city, that had to postpone plans to roll out an EMR), and to the tens of millions in the U.S. who apparently lack health insurance, such bragging might be interpreted along the lines of this infamous lady who at one point lost her head.

This was partly as a result of a rather insensitive line about pastries - something about letting the peasants eat cake.

(Perhaps Mr. Barrett's horses can talk, like Mr. Ed, and can give as complex a medical history as a human patient and opine on electronic health records as well):

A horse is a horse
Of course, of course
And no one can talk to a horse of course —
That is of course unless the horse
Has an equine EHR.

Go right to the source and ask the horse —
He'll give you the medical history that you'll endorse
He's always on a steady course
The horse has EHR!

People yakity-yak a streak
And waste your time of day,
But a horse will never speak
Unless he has something medical to say!

A horse is a horse
Of course, of course
And this one will complain about EHR privacy 'till his voice is hoarse
You never heard of a talking horse?
Well listen to this:
"I am a horse with EHR!"

-- SS

BLOGSCAN - Why Do People Trust Medicare?

On Marginal Revolution (an increasingly influential libertarian economics blog), this post on whether or not people in the US trust our Medicare program. Blogger Tyler Cowen suggests that "people like Medicare because it pays some of the bill, while keeping interference in the medical process to an apparent minimum; admittedly non-interference is in part illusory because the indirect effects of Medicare (e.g., it drives up prices) have become enormous." One wonders if people knew more about the obscure process Medicare uses to adjust reimbursement to physicians (see our posts here and here), whether they would trust Medicare less.

BLOGSCAN - More About Conflicts of Interest and Provenge

On PharmaLot, this post updates the Provenge story. We had posted about it here, emphasizing how relevant conflicts of interest muddied an already muddled story. Now, there is even more controversy over accusations about conflicts of interest. Unfortunately, the presence of such conflicts often turn scientific disputes into "he said, she said" sorts of arguments in which the money at stake drowns out the science.

Clinical IT mayhem is good for [the IT] business

Clinicians are being asked to become entirely dependent on clinical IT in performing their roles, and the data from the clinical IT will undoubtedly be used to alter clinical power structures, reimbursement, and liability.

Blind faith in the IT and business "experts" is a sure path to hell.

Here's an example of the issues clinicians face from the providers and implementors of this technology - mostly non-clinicians. This collage of issues comes from the former head of the UK's Connecting for Health national clinical IT program, Richard Granger. See article below:

"Sometimes we put in stuff that I'm just ashamed of ... Some of the stuff that Cerner has put in recently is appalling ... Cerner and prime contractor Fujitsu had not listened to end users ... Failed marriages and co-dependency with subcontractors ... A string of problems ranging from missing appointment records, to inability to report on wait times ... Almost a dozen cancelled go-live dates ... Stupid or evil people ... Stockholm syndrome -identifying with suppliers' interests rather than your own ... A little coterie of people out there who are "alleged experts" who were dismissed for reasons of non-performance."

It is quite literally amazing how a national program to implement health IT, that has spent billions of dollars to date, is plagued by the same problems I observed and wrote about almost a decade ago. Every one of the above issues, and more, are found even in organizational-level clinical IT projects.

One wonders if anyone will learn from these issues.

I tend to doubt it. The motto of this industry may well be "Clinical IT mayhem is good for [the IT] business."

This is unfortunate. I am a strong advocate of clinical IT, but as I have written on many occasions, clinical computing and business computing (management information systems) are different subspecialties of computing, and clinical IT will significantly benefit healthcare quality, efficiency and costs, but only if done well.

In getting clinical IT 'done well", it's not about "process" and "six sigma" and "business process re-engineering." There simply is no substitute for brains, integrity (conflict of interest and integrity being polar opposites), proper expertise, and significantly less arrogance from the IT industry about how virtual clinical tools should be developed and deployed.

-- SS

Granger says he is 'ashamed' of some systems provided

E-Health Insider, 10 Jul 2007

http://www.e-health-insider.com/news/item.cfm?ID=2854

The departing head of the NHS IT programme Richard Granger has said he is ashamed of the quality of some of the systems put into the NHS by Connecting for Health suppliers, singling Cerner out for criticism.

Going further than he before in acknowledging the extent of failings of systems provided to some parts of the NHS - such as Milton Keynes – the Connecting for Health boss, said "Sometimes we put in stuff that I'm just ashamed of. Some of the stuff that Cerner has put in recently is appalling."

He said a key reason for the failings of systems provided was that Cerner and prime contractor Fujitsu had not listened to end users. "It really isn't usable because they have building a system with Fujitsu without listening to what end users want. They have taken some account but they then had to take a lot more. Now they are being held to account because that's my job."

The latest remarks, quoted in an interview in the current issue of CIO magazine , appear to make a nonsense of Granger's June statement that unless agreement was reached between Computer Sciences Corporation and iSoft over its acquisition by IBA Health, Cerner could wind up as the system used across the whole of the English NHS.

In December 2005 Nuffield Orthopaedic Centre became the first NHS site to go live with Cerner Millennium under the NHS IT programme. It has since suffered a string of problems ranging from missing appointment records, to inability to report on wait times. The Millennium system – now installed at six NHS locations in the South – remains unable to directly integrate with Choose and Book or meet 18-week reporting requirements.

In April, 79 members of staff from Milton Keynes NHS Trust signed a letter outlining their frustrations at the Millennium system, stating: "In our opinion the system should not be installed in any further hospitals.

CfH said there had been some "unacceptable problems" with the new system installed at Milton Keynes. The hospital trust was subsequently visited by Granger and NHS chief executive David Nicholson to learn of the problems first hand.

At the end of June, David Wrede, a senior consultant at Taunton and Somerset Hospital NHS Trust, exasperated by almost a dozen cancelled go-live dates, gave vent to his frustrations with the version of the Millennium system on offer from Fujitsu the local service provider in the South.

Speaking at the BMA's annual representative meeting on 29 June Wrede said: "We should have a public inquiry. The people who made the original Cerner contract should be brought to book and as Cerner Millennium R0 [release zero] is not fit for purpose…" The motion calling for a public enquiry was passed.

The first Cerner installation by BT, the NPfIT contractor in London, is scheduled to go live at Barnet and Chase Farm NHS Trust within the next week. The trust is understood to be due to recieve the same release zero version of the Millennium software that has so far been used in the South. Later sites in London will use London-specific versions of the software.

Granger also cast further light on Accenture's departure from the NPfIT programme at the end of 2006, describing their relationship with sub-contractor iSoft as a failed marriage, in which they had failed to realise their co-dependency. He contrasted the relationship with iSoft with Accenture's performance on Picture Archiving and Communication Systems with Agfa as its sub-contractor. "When they work with a mature, high quality vendor that recognises Accenture as in charge and they're doing it their way, you get a quite good deal and they'll do the job."

The CfH boss goes on to state that he has been careful to avoid Stockholm syndrome -identifying with suppliers' interests rather than those of the NHS - as problems have mounted.

"One supplier asked for an extra £500m to deal with cost overruns. He received a succinct refusal but there are many places where the response would have been different; where threats of bad publicity and contract disputes would persuade an organisation to start bunging millions of pounds a month in addition to the existing contract, just to cover up," says Granger.

Elsewhere in the in-depth valedictory interview carried out ahead of Granger announcing his resignation, he rounds on critics and erstwhile colleagues, saying. "Either people are really stupid or evil. It's difficult to be compassionate with people who claim that suppliers are going out of business because they are not getting paid or they were withdrawing from wishing to do business with the NHS. At the same time, they are saying they [the suppliers] have been bunged millions of pounds that weren't budgeted for. It's stupid or wicked."

He reserves particular ire for so-called experts. "There is a little coterie of people out there who are alleged experts and who worked on this programme. They were dismissed for reasons of non-performance or in one case, for breach of commercial confidentiality.

"He actually sent our financial model to a supplier and that's why we suspended him. He then resigned which is an answer in itself."

Granger continued: "Who contributed evidence to the public accounts committees? For just about every figure quoted as an expert in this programme, I've got HR files on them. They generate a piece of opinion that often substantiates their world view."

Link
The full CIO article can be read at
http://www.cio.co.uk

Naming a School of Public Health After a Health Insurance Company: An Idea that Refuses to Die

We previously posted about a proposal to name the new school of public health at the University of Iowa after a local health insurance company. But the faculty roundly rejected the notion of a "Wellmark Blue Cross and Blue Shield College of Public Health," and that seemed to be the end of the idea.

But maybe not. On Inside Higher Ed was a report that the faculty reconsidered.

Earlier this month, professors at the University of Iowa decided that they’d rather not work at the 'Wellmark Blue Cross and Blue Shield College of Public Health' — even if it meant potentially losing a donation of $15 million, which the insurance company’s nonprofit philanthropic arm promptly rescinded.

But it looks like a significant proportion of the university’s faculty members are having second thoughts. At a meeting on Monday morning, they passed another resolution, this time resolving to 'move forward and consider this naming gift at a collegiate faculty meeting early in the [2007-8] academic year.'

Apparently some faculty were happy to shorten the name.

A faculty member who was present at Monday’s meeting said he believed that there was a strategy behind rescinding the offer and then taking the issue back to the faculty. One possibility tossed around, the professor said, is that the insurer would now settle simply for the 'Wellmark College of Public Health,' assuming the faculty could be brought around to the idea. In theory, both parties could argue that the name refers to the foundation and not the insurance company itself.

Meanwhile, there has been a backlash against the faculty's initial rejection of the concept of a Wellmark School of Public Health. According to the Des Moines Register,

Des Moines businessman Marvin Pomerantz, a former president of the Iowa Board of Regents, says the dean of the University of Iowa's College of Public Health should be fired for turning down a $15 million gift from Wellmark Blue Cross and Blue Shield insurance company.

'We need to pay him off and get him out of there,' Pomerantz said of Jim Merchant, who has been dean of the college since it was founded in 1999. Merchant plans to retire next year.

'I think the new president will take care of the dean. He needs to go,' Pomerantz said Wednesday.

Pomerantz, a prominent U of I donor whose name is on a pavilion at University of Iowa Hospitals, resigned last week from a fundraising committee for the public health college after Merchant and the college's faculty members approved a resolution on July 5 stating they did not want the college to be named after Wellmark, Iowa's largest health insurance company.

Meanwhile, it appears that the acting university president has been working on some way to keep the Wellmark school naming alive, again per the Register.

Interim University of Iowa President Gary Fethke played a key role in persuading faculty members in the U of I College of Public Health to reconsider a controversial $15 million gift from the Wellmark Foundation, faculty said this week.

But Fethke presented the idea Monday of dropping 'the Blues' from the name, said faculty members who attended the meeting.

Fethke distributed a mock-up letterhead showing the college's name if it were changed to the Wellmark College of Public Health.

An article in the Iowa City Press-Citizen suggested that part of what is going on has to do with the history of the relationship between Wellmark Blue Cross and Blue Shield and the University of Iowa.

Pomerantz, a former Wellmark director, and University Hospital Director Emeritus John Colloton, a current Wellmark lead director, approached the Wellmark board for the money, although the offer came from the Wellmark Foundation, a charitable organization created by Wellmark. They were both serving on the public health colleges capital campaign, though Pomerantz has since resigned.

Wellmark CEO John Forsyth, a former regent president who resigned in 2005 in the middle of a contentious contract dispute between UI and Wellmark, withdrew the offer.

All the more reason not to name the school of public health after Wellmark, with or without the "Blues."

In my humble opinion, the switch from "Wellmark Blue Cross and Blue Shield College of Public Health" to "Wellmark College of Public Health" is a distinction without a difference.

Either way, naming a college of public health for a local health insurance company in return for $15 million certainly suggests the appearance of obvious institutional conflict of interest. And the historical ties among some of the university's leadership with Wellmark are all the more reason not to take on this added tie.

The University Regents and top administration ought to sit down and ponder long and hard what the missions of the university and its school of public health ought to be. They ought not to include promoting a local health insurer.

Only $50K Per Physician a Year for Drug Company Sponsored Talks?

Again on Question Authority with Dr Peter Rost is this post on how US pharmaceutical companies use physician key opinion leaders to give talks promoting specific products. Rost came up with apparently genuine emails from Pfizer Inc. drug representatives touting a specific physician as a speaker whose talks on the cardiovascular risks of HIV patients could be used to promote the use of the anti-retroviral drug Viracept (nelfinavir). Further, the emails note that while the usual internal rules limit any given speaker from receiving more than $50,000 in honoraria from Pfizer per year to give such talks, these rules can be bent.

Assuming the authenticity of the emails, this post highlights some important points

• Pharmaceutical companies pay physicians to speak as a way to market their products
• Physicians can make considerable amounts of money doing so

Thus, as I have said before, physicians who are paid part-time to give talks to help market drugs should make that fact clear when they give these talks. If they would be embarassed to do so, then maybe they should be embarassed to give such talks.

Finally, giving such marketing talks without acknowledging their purpose is a form of stealth marketing, and is inherently dishonest both for physicians involved and the companies that pay them.

Challenge to the audience: what are other words for dishonest marketing?

BLOGSCAN - Even European Pharma Execs Don't Like DTC Advertising

On BrandweekNRX is a fascinating post on the disdain European pharmaceutical executives have for direct to patient (DCT) pharma advertising. On UK executive even said "that American drug advertising was regarded as so excessive in the UK that it had actually nixed the chances of UK drug companies being allowed to conduct similar promotions."

And the post started with a link to Question Authority with Dr Peter Rost which cited a commentary in a left-wing Swedish newspaper in which a Swedish Pfizer executive called DTC advertising "a bad model for Sweden."

So why do American pharma executives swear by DTC advertising? Are they dumber than their European counterparts, or are American consumers more gullible than European consumers?

Another Species of Conflicts of Interest: A Board Interlock Between a Managed Care Organization and a Medical Device Company

On the Wall Street Journal Health Blog, this post notes that Jack Lord, who is a Senior Vice President at Humana, just resigned from the board of NeuroMetrix, a small medical device manufacturer. The post focused on whether the resignation has to do with NeuroMetrix's current legal problems.

I wondered (and asked in a comment) whether Lord's position on both boards was yet another species of board-level conflicts of interest. After all, Humana is a managed care organization/ health care insurer which promises an approach which "makes health benefits affordable, easy to administer and use, and instills confidence in both employees and employers." Presumably, one component of making health care more affordable would be negotiating fair prices with providers and suppliers, including medical device manufacturers. In fact, wasn't a major rationale for the managed care movement that managed care would lead to more rationale pricing. Yet wouldn't a degree of board interlocking make it unlikely that two companies would negotiate fairly with each other?

Avandia to be Reviewed by FDA Board with Conflicted Members

We have posted quite a bit, most recently here, about the spinning that went on after the New England Journal of Medicine published a meta-analysis which suggested that the anti-diabetic drug rosiglitazone (Avandia, by GlaxoSmithKline) might have heretofore unrecognized cardiovascular adverse effects. Later this month, the US Food and Drug Administration (FDA) will convene an advisory panel to discuss the risks of Avandia and similar drugs. Bloomberg just reported,

Six doctors with financial ties to the pharmaceutical industry, including stock holdings or speaking fees, will be among members of a U.S. advisory panel on the use of a GlaxoSmithKline Plc diabetes medicine linked to heart risks.

The doctors will discuss the safety of the drug, Avandia, and similar treatments at a July 30 meeting convened by the Food and Drug Administration. As many as four of the six doctors with conflicts may vote on recommendations to the FDA, according to financial disclosure documents released by the agency. The agency wouldn't say how many members the committee will have.

Bloomberg was able to find out something about some of the conflicted panel members.

The FDA's documents for Thomas Pickering, a professor at Columbia University Medical Center in New York, said he was paid less than $10,001 a year for serving on a drugmaker's advisory board and had stocks in drug companies. Pickering, 67, who is a voting member of the panel, said in an interview that he served earlier this year on an advisory board to Bristol-Myers Squibb Co., a New York-based drugmaker....

Another voting member, David S. Schade, a professor at the University of New Mexico School of Medicine in Albuquerque, received less than $10,001 a year as a member of a speaker's bureau for a drugmaker whose products compete with those to be discussed at the panel meeting, according to the FDA.

[John R.] Teerlink, director of the heart-failure clinic at the San Francisco Veterans Affairs Medical Center, also received $10,001 to $50,000 a year as a study reviewer for a drugmaker, which he identified as Bristol-Myers. The FDA paperwork doesn't make clear whether Teerlink will vote.

Steven Nissen, first author of the controversial meta-analysis, and Curt D. Furberg, who wrote an accompanying editorial, will both serve as non-voting panel members.

Of course, the conflicted panel members say that their conflicts will not affect how they will vote.

The financial ties won't affect his recommendations, Pickering said.

'I would not serve on the panel if I felt that I had conflicts that would interfere with my ability to objectively interpret the data and make decisions to help protect the public health,' Teerlink, 46, said in an interview.

Others differ.

'They shouldn't appoint people with conflicts of interest,' said Merrill Goozner, director of the Integrity in Science project at the Washington-based Center for Science in Public Interest, in an interview. 'The public perception of the evenhandedness of the process will be immeasurably enhanced if they appoint only people who do not have conflicts.'

A while back we blogged about a proposal that appeared in JAMA to prevent physicians from receiving even small gifts from pharmaceutical companies (e.g., pens, coffee mugs, pizza lunches) because of the evidence that even such small gifts may affect their clinical decision making. See our post here, and the article here (Brennan TA et al. Health industry practices that create conflicts of interest: a policy proposal for academic medical centers. JAMA 2006; 295: 429-433.)

If you accept the idea that even the gift of a pen might affect a physician's therapeutic judgment, why wouldn't a consulting job paying thousands a year affect an advisory panel member's scientific judgment? After all, if one is paid thousands to consult for company x, wouldn't one tend to favor company x's products and services?

We noted here that the Avandia spin cycle was receiving much of its rotational velocity from people who had a variety of relevant vested interests. It would have been nice if we had confidence that the FDA review of the drug's possible adverse effects would be done by people with no relevant vested interests. But that, it appears, won't be the case.

We fear that practicing physicians and other health professionals in the trenches, and the public at large, will just get more and more disillusioned about health care as long as the discourse is dominated by people with vested interests (other than in advancing health, education, and science.)

Hat tip to PharmaGossip.

BLOGSCAN - Stealth Advocacy in Sweden

On the Scientific Misconduct Blog, Dr Aubrey Blumsohn posted about the role of a Swedish disease-oriented patient advocacy group in the "Gillberg affair." The group, which apparently tried to discredit a whistle-blower in the case, turns out to be funded by the pharmaceutical industry. It looks like stealth advocacy is an international issue.

Scrap the national IT plan?

The Archives of Internal Medicine just published an article "Electronic Health Record Use and the Quality of Ambulatory Care in the United States" that assessed the association between EHR use, as implemented, and the quality of ambulatory care in a nationally representative survey (summary here.) The article concluded:

"As implemented, EHRs were not associated with better quality ambulatory care."

The key words are "as implemented" - which, as readers of my other posts about EHR's know, often means "poorly."

This story was picked up by the Rush Limbaugh talk program, that has an audience of perhaps 20 million listeners, as well as the health care blog of the Wall Street Journal in an article entitled "Computerized Medical Files Not Much Better Than Paper."

This is very bad publicity for this previously-cozy sector.

Cozy for IT vendors, hospital IS departments and high-paid management consultants who monopolize it, that is, not clinicians, who usually become data entry clerks and whose professional lives are usually made more difficult by often ill-conceived, poorly-designed and poorly-implemented systems, and not medical informatics experts, whose advice is often ignored and who are often marginalized in hospitals as "Director of Medical Informatics" a.k.a. "Director of Nothing."

Further, I can't disagree with most of the points in the following editorial in Modern Healthcare. Modern Healthcare points out health IT issues I have previously written about, including politics, finances, benefit vs. risk, conflicts of interest, simplicity and usability vs. needless complexity, and sums them all up in a concise manner. I think the difficulties of other national initiatives bears out this opinion.

I don't think the medical, IT or political worlds are ready for full electronic medical records yet. The progress in hardware has vastly outpaced the progress in wetware (i.e., grey matter).

Perhaps it is time for stepping back and reconsidering what we are trying to do through computerization.

Modern Healhcare
Jul 12, 2007
Editorial: Scrap the national IT plan

It should be clear by now that unless the federal government mandates a single healthcare information technology platform for all healthcare providers and heavily subsidizes its adoption, we won’t meet President Bush's goal of a national electronic medical-record system by 2014—or anytime after that. As there isn't the political will or the financial resources to accomplish such a national system, other solutions must be found.

The answers won't be forthcoming from the privatized mess left by the Bush administration, which is no closer to success on its interoperable IT system than it was when it started the process three years ago. It has left "control" of the health IT process in the hands of a contentious mix of IT vendors, data-miners, insurers and a handful of healthcare interest groups. The only ones left out are the American people, who might be concerned that invading their privacy may be the signal accomplishment of this concatenation of conflicts of interest. If you don't believe me, read the reports on the process from the Government Accountability Office or any of our past articles on the subject.

Most recently, HHS Secretary Mike Leavitt announced that the American Health Information Community—his advisory panel charged with recommending IT standards—would be privatized by 2009. As Rep. Pete Stark (D-Calif.) has pointed out, if the private sector were intent on having a system of interoperable medical records, it would have done so many years ago, as other leading industries did.

Strong presidential leadership on the issue—particularly in helping providers pay for IT—is needed, but it isn't clear from whom that would come. It may have to be someone who isn't in the Senate now. A bipartisan bill on health IT that is now up for consideration by the full Senate, called the Wired for Health Care Quality Act of 2007, would merely codify the same process we see unfolding in Washington today, including a lack of concern for patient privacy and an overreliance on private industry. One of its key backers is Democratic front-runner Hillary Rodham Clinton.

Why is it that nobody in government recognizes that the sharing of any data should be for medical and research purposes only? Until government absorbs this lesson, we shouldn't have a national IT system.

Not that there is any real threat of one. Only about 10% of physician offices have electronic medical records. While hospitals have adopted them at a faster rate, success stories involving the ability to share data across a system are rare indeed. Even pioneering efforts have foundered on physician resistance and technological snafus.

What may be needed now is simplicity, something in short supply when IT experts get together. One thing that stands out is that modest IT success tends to happen in larger, integrated health systems. Doctors operating in small practices, without any formal ties to hospitals beyond admitting privileges, may simply be left behind on the IT front.

Simply digitizing medical records and adopting computerized physician order-entry and decision-support software are huge steps in terms of patient safety and care quality.

In terms of sharing data among unrelated providers, why don’t we try using smart cards, as is being done in a regional health information organization in the New York area? Patients can carry the cards when traveling, and the complete medical record, updated on each office or hospital visit can be downloaded with a simple USB reader.

These and other relatively simple steps may be what passes for healthcare IT, at least for the foreseeable future. It would be more affordable than current plans. National interoperability can wait, at least until there is a national consensus that the needs of patients are greater than the needs of private business seeking to cash in on identifiable patient data.

To that I have nothing to add.

-- SS

Who'da thunk it? -- Personal Health Record project with big corporate sponsors not working out so well ...

The Dossia PHR (Personal Health Record) project, whose corporate members include Wal-Mart and Intel, is in a bit of trouble.

I predicted problems might arise in previous Healthcare Renewal posts:

"Big employers plan electronic health records (and a manned Mars expedition as a warmup?) "

"On Intel's and Walmart's prescription for Healthcare IT."

Here is the latest on what appears to be a significant debacle in the making:

Information Week: Major E-Health Records Project Unravels Into Legal Battle

Marianne Kolbasuk McGee, July 11, 2007 http://www.informationweek.com/story/showArticle.jhtml?articleID=201000830

Electronic health systems are supposed to help improve health care. But apparently, if you're involved with a big project to build an e-health records system, it can be harmful to your own health. Side effects may include headaches, lost sleep, and lawsuits.

Especially when electronic health systems are not your core competency...

Those are just some of problems being faced by those involved with the ambitious e-health record systems project launched in December by the Dossia Consortium, an employer coalition that includes Wal-Mart, Intel, Pitney Bowes, Applied Materials, British Petroleum, and Cardinal Health.

Dossia's ambitious project to provide e-health records to more than 2.5 million employees, retirees, and dependents is unraveling, at least when it comes to the relationship it has with Omnimedix Institute, the nonprofit organization that Dossia hired to develop the system, which was to include a massive, federated data warehouse.

Yes, a project to provide e-health records to more than 2.5 million employees, retirees, and dependents is just a piece of cake for the Intels and Wal Marts of the world. After all, they track 2.5 million widgets with ease.

Legal papers are starting to fly. A temporary restraining order was quietly filed in late June by Dossia against the Portland, Ore.-based Omnimedix in the circuit court of the state of Oregon for the county of Multnomah. According to court papers filed by Dossia, Ominmedix is temporarily restrained from filing any suit of its own except under seal.

Just what the public needs to inspire confidence in Personal Health Records sponsored by employers...

A source familiar with the situation says trouble had been brewing for months, even though the alliance between Omnimedix and Dossia is only about six or seven months old. The source says Omnimedix was seeking payment from Dossia, but that Omnimedix had failed to provide "deliverables" for the project so far, and that Dossia was demanding money back that it had already paid to Omnimedix. Neither [Onnimedix CEO] J.D. Kleinke nor a Dossia spokeswoman would comment on those allegations.

Kleinke said that under the contract signed last year between Omnimedix and Dossia, Dossia was to pay Omnimedix $15 million to build a system that would allow Dossia members' employees to access their own personal health records via the Web. By mid-2007 -- about now -- some Dossia members were expected to begin using the system. Kleinke admits that has not happened and the system hasn't yet gone online. Kleinke says details discussed with InformationWeek about Dossia appear in "public documents," including court papers related to the restraining order, and that he's not revealing confidential information.

Does the word "boondoogle" apply here?

I met J.D. Kleinke in the past. We were on a presentation panel in 1999 at a Capitol Hill healthcare conference sponsored by the Ethics and Public Policy Center in Washington, D.C.

J.D. is a medical economist and author of "Oxymorons: The Myth of a U.S. Healthcare System" among other books. He seemed to have an excellent understanding of the sociotechnical problems in healthcare IT, so although I have no further information beside the Information Week article, my gut feeling is that the problems are likely coming from the big-corporate side.

While the Dossia effort is ambitious in that it's the largest employer coalition currently attempting to provide workers with personal e-health records, Dossia isn't alone in the problems it's encountering in getting its e-health system moving along.

The e-health record landscape is littered with promising but complex projects that have had disappointing outcomes or quiet deaths because of a number of factors, including lack of funding, underutilization by doctors and others, concerns about patient privacy, medical liability, competition, and technology glitches. (and incompetence? - ed.)

You don't say...

-- SS

Advocacy in Whose Interest? - The Pharmaceutical Industry, the Epilepsy Foundation, and Generic Anti-Epileptic Prescribing

Just in time for another lazy summer weekend comes this article from the Wall Street Journal about another instance of cozy ties between the pharmaceutical industry and a disease-specific not-for-profit organization. (We posted about another such instance here.) The article's focus is how the Epilepsy Foundation has been campaigning against generic anti-epileptic drugs on a state level, while accepting significant funding from and leadership by pharmaceutical companies that make name brand anti-epileptics. First, the background,

Four major brand-name drugs used for epilepsy are expected to lose patent protection and face generic competition between next year and 2010. Those four drugs generated $5 billion in U.S. sales last year.

When a doctor writes a prescription for a brand-name drug, pharmacists are usually permitted in most states to make an automatic switch to a generic judged equivalent by the FDA.

In the late 1990s, the national Epilepsy Foundation, based in Landover, Md., raised concerns about anecdotal reports that some patients experienced seizures and side effects after switching epilepsy drugs. Some of the episodes involved patients who had been switched to a generic from a branded drug. The foundation also worried about cases in which patients were switched from one generic version of a drug to another generic version of the same drug.

The foundation theorized that some generic pills had a meaningful difference from the brands. This difference, it postulated, meant patients were getting more or less of the drug in their blood, causing some of them to have seizures or side effects. Foundation officials floated the idea in a 1999 meeting with the FDA.

The FDA's response: 'Show us the data,' recalls Sandy Finucane, who oversees state and federal policy for the foundation. The agency, unpersuaded by what it saw, stood firm in its long-held position that the difference was too small to have a tangible impact on patients.

In early 2006, the issue re-emerged as legislation requiring doctor permission for switches was proposed in Illinois.

In May 2006, the national Epilepsy Foundation convened a committee of medical experts to examine the question. The committee found a lack of authoritative studies showing that such drug switches cause problems, says its chairman, Steven Schachter, a Harvard Medical School neurologist. Nonetheless, it recommended that doctors give explicit approval for switches, citing anecdotal reports of seizures and noting that such attacks can be serious.

Now, about those ties among the foundation and pharmaceutical companies.

The foundation and its state affiliates receive funding from the epilepsy-drug makers. GlaxoSmithKline PLC and UCB SA donated $500,000 to $999,999 each in fiscal 2006 to the national foundation, according to its annual report. Abbott Laboratories and a Johnson & Johnson unit each contributed $100,000 to $499,999. Representatives of four drug companies sit on the foundation's board, as does PhRMA chief Billy Tauzin.

The foundation says its diverse funding base shields it from undue drug-company influence, and the industry executives on its board didn't participate in discussions of the drug-switching issue. Foundation leaders note that the state bills would generally require doctor permission for several kinds of switches, including when a patient goes from a generic to a brand.

'These are people's lives that we're talking about -- nothing about stock options and stock value and how this would affect [companies'] bottom line. That would be insulting to us to have discussions like that,' says Sindi Rosales, the head of a foundation affiliate in Texas, one of the states that weighed legislation this year. She says pharmaceutical companies are 'fabulous partners' and their help in several areas 'has been amazingly tremendous,' but the companies leave it to the foundation to call the shots.

For their part, company executives describe their lobbying role as limited and say the bills were primarily an initiative of the foundation, although they acknowledge in certain cases that company officials have gotten directly involved. Executives say the aim of these activities is to protect the health of patients.

Here we go again. We have noted before that conflicts of interest may not consciously affect human decision making, and how people affected by conflicts may be genuinely indignant when confronted with suggestions that the conflicts consciously influenced their decision making. But, "people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult" (see post here).

However, there is ample evidence that conflicts may affect how people think and what they do. Try a thought experiment. If you knew that your organization were getting a large amount of money from donor x, would you be more likely to take a position that directly goes against the interests of donor x, or the opposite?

In any case, this case appears to be yet another example of stealth health policy advocacy or stealth lobbying, and one that may succeed in keeping the costs of drugs rising ever higher.

See Pharmalot's related post here, and the Wall Street Journal's Health Blog's here.

BLOGSCAN - When Fighting Wooden-Headed Reimbursement, No Good Deed Goes Unpunished

On the Running a Hospital blog, Paul Levy describes how Virginia Mason Medical Center in Seattle tried to increase the quality and efficiency of its services for specific medical conditions, with prompting from health insurer Aetna Inc. We had posted about these efforts, which seemed to be one antidote to the sort of wooden-headed health reimbursement policies leading to higher costs and lower quality that we have decried. The problem with Aetna's and Virginia Mason's well-intentioned efforts were that they have hurt the Medical Center's bottom line, which is mainly a factor of the traditional, wooden-headed reimbursement policies of other commercial insurers, and of Medicare and Medicaid. It seems no good deed goes unpunished....

Censored Surgeons General

Several major newspapers (including the Los Angeles Times, New York Times, and Washington Post) just reported on testimony of three former US Surgeons General about politically based attempts to censor them. Most of the emphasis was on the testimony of Dr Richard H Carmona, former Surgeon General under President George W Bush. To quote the Washington Post's story,

Former surgeon general Richard H. Carmona yesterday accused the Bush administration of muzzling him on sensitive public health issues....

Political appointees in the administration routinely scrubbed his speeches for politically sensitive content and blocked him from speaking out on public health matters....

'Anything that doesn't fit into the political appointees' ideological, theological or political agenda is often ignored, marginalized or simply buried,' he said. 'The problem with this approach is that in public health, as in a democracy, there is nothing worse than ignoring science or marginalizing the voice of science for reasons driven by changing political winds.'

Particular issues about which Carmona charged he was censored included stem cell research,

He was told not to speak out during the national debate over whether the federal government should fund embryonic stem cell research, which President Bush opposes.

'Much of the discussion was being driven by theology, ideology, [and] preconceived beliefs that were scientifically incorrect,' said Carmona, one of three former surgeons general who testified at yesterday's hearing. 'I thought, 'This is a perfect example of the surgeon general being able to step forward, educate the American public.' . . . I was blocked at every turn. I was told the decision had already been made -- 'Stand down. Don't talk about it.' That information was removed from my speeches.'

Also, there was sex education,

Carmona said that when the administration touted funding for abstinence-only education, he was prevented from discussing research on the effectiveness of teaching about condoms as well as abstinence. 'There was already a policy in place that did not want to hear the science but wanted to just preach abstinence, which I felt was scientifically incorrect,' Carmona said.

And second hand smoke, according to the New York Times,

Top officials delayed for years and tried to 'water down' a landmark report on secondhand smoke, he said. Released last year, the report concluded that even brief exposure to cigarette smoke could cause immediate harm.

Carmona was even warned about attending the Special Olympics,

And administration officials even discouraged him from attending the Special Olympics because, he said, of that charitable organization’s longtime ties to a 'prominent family' that he refused to name.

'I was specifically told by a senior person, ‘Why would you want to help those people?’ ' Dr. Carmona said.

The Special Olympics is one of the nation’s premier charitable organizations to benefit disabled people, and the Kennedys have long been deeply involved in it.

When asked after the hearing if that 'prominent family' was the Kennedys, Dr. Carmona responded, 'You said it. I didn’t.'

And some reports are still on ice, according to the New York Times,

Dr. Carmona said drafts of surgeon general reports on global health and prison health were still being debated by the administration. The global health report was never approved, Dr. Carmona said, because he refused to sprinkle the report with glowing references to the efforts of the Bush administration.

Two other Surgeons General testified. They were Dr David Satcher, who served under President Bill Clinton, and briefly under President George H W Bush and Dr C Everett Koop, who served under Ronald Reagan. Both also cited politically driven attempts to censor them. As the Post put it,

Two other former surgeons general, David Satcher and C. Everett Koop, said at the hearing that political interference appears to have grown worse under Bush, although they noted that this administration has not been the only one to take a political approach toward the office.

Under Clinton, Satcher was censored about health and sexuality,

Satcher, Carmona's predecessor, who served from 1998 to 2002, said that under President Bill Clinton he could not release a report on sexuality and public health, in part because of sensitivities triggered by the Monica Lewinsky scandal.[WaPo]

The Washington Post article also noted,

Clinton also forced out Joycelyn Elders as surgeon general in 1994 after her controversial remarks that public schools should consider teaching about masturbation.

Satcher also was censored about substance abuse,

Dr. Satcher said that the Clinton administration discouraged him from issuing a report showing that needle-exchange programs were effective in reducing disease. He released the report anyway.

Under Reagan, Koop was told of political pressures on Reagan, but apparently was shielded from them by the President,

Koop, who served as surgeon general under President Ronald Reagan, spoke out on AIDS, despite political pressure not to do so. He said Reagan was pressured to fire him every day -- but he did not.

'If he had not been the kind of person he was, I would not be here today,' Koop said [WaPo]

On Health Care Renewal, we often discuss cases in which research results have been suppressed, or discussion of various health care issues has been discouraged. Often those doing the censoring in these cases appeared to have been acting out of economic self-interest.

These new and not so new stories remind us that people with political vested interests may also be eager to shape the debate about health care issues, and even try to completely shut up people whose positions offend them.

On the other hand, as we have said many times, for patients and doctors to make the best possible clinical decisions, they need access to the best possible evidence about tests and treatments. Furthermore, to make the best possible health policy decisions, people and policy-makers need access to all relevant evidence and view-points.

Stifling dissemination of information or debate to serve vested interests, whether these interests are primarily economic or political, is bad for patients and bad for people in general.