Monday, March 31, 2008

Smoke Alarm: Tobacco Funding of Medical Research at Reputable Medical Schools May be Prevalent

We recently posted about a controversial study of using CT scans to screen for lung cancer that turned out to have been partially sponsored by a tobacco company. Even though we have written quite a bit about conflicts of interest, this surprised even me, since the conflicts of interest presented by financial relationships with tobacco companies seem so blatantly risky that I would have thought few physicians or medical researchers would dare contemplate them. It looks like even having blogged on Health Care Renewal for several years, I am still too naive.

For example, the Boston Globe just reported on funding of medical research in the Boston area just by tobacco company Philip Morris USA, just spun off from Altria Group Inc.

The nation's largest cigarette maker has paid for scientific research at four Massachusetts universities since 2000....

Philip Morris USA, which makes Marlboro and other top-selling cigarette lines, gave grants to scientists at Boston University, Harvard University, the Massachusetts Institute of Technology, and the University of Massachusetts, company spokesman David M. Sylvia said Friday.

The research supported by the company touched on conditions such as heart disease and cancer that are linked to smoking.

Funding went to Boston University.

BU's acceptance of research grants from Philip Morris was first disclosed Thursday in The Daily Free Press, a student newspaper at the university.

At BU, one recipient, Dr. Douglas Faller, is a longtime professor and director of the BU Cancer Center. According to a document detailing work at the university's Women's Health Interdisciplinary Research Center, Faller received $268,759 from Philip Morris to investigate a cancer drug.

Reached at his home late Friday, Faller deferred to university officials for comment.

Funding went to Harvard, although it has decreased since Harvard banned new tobacco funding of research in 2004.

At Harvard Medical School, researchers were ordered to stop pursuing tobacco-industry grants in July 2004. 'The policy did, however, allow those few researchers who had ongoing projects funded by those entities to complete them,' Margaret Dale, dean for faculty and research integrity at Harvard Medical School, said in a statement released Friday by a university spokesman.

Funding previously went to University of Massachusetts Medical Center, but the institution does not currently get tobacco funding.

A UMass Medical School spokeswoman said that the school does not currently have any research supported by tobacco companies and that it had accepted 'no more than' $2 million from the industry over the past decade.

No Philip Morris funding went to Tufts University School of Medicine, but the school did admit to receiving money from another tobacco company.

The Tufts University School of Medicine received no Philip Morris grants, but a school spokeswoman said that one laboratory there had received a grant in 2006 from a tobacco company.

The argument against funding of clinical research by pharmaceutical, biotechnology and medical device companies has been that such companies often try to exert influence, subtle or overt, that might bias the research to favor their products, or even suppress research that shows their products in a bad light. Such influence could adversely affect the advancement of science, and decision making by physicians and patients who accept the published research as unbiased. Such influence also breaks the trust of research subjects who were told that they were volunteering to advance science and health care.

But at least pharmaceutical, biotechnology, and device companies make products intended to help patients more than they harm them.

Tobacco products obviously pose serious health risks, and have no health benefits to counterbalance them. So the bias that could result from tobacco companies' sponsorship of research could be much worse for science, for medical decision making, and for research subjects than bias resulting from pharma, biotech, or device companies' research sponsorship.

Yet some medical schools seem to push their faculty so hard to get "external research support" that they do not mind if such support comes from tobacco companies.

Kudos to Harvard, though, for trying to cut back.

No medical school administrator nor researcher willing to be quoted by the Boston Globe reporter dealt directly with why tobacco company research support might not be a good idea. For example,

In a statement issued Friday evening, the provost of BU's medical campus, Dr. Karen Antman, said the school had received $3.99 million from Philip Morris during the past decade and devoted it to the study of tobacco-related diseases.

'We adhere to the highest ethical conduct in research and pursue funding from a variety of sources for unrestricted medical research,' Antman said in the statement. 'Our research is conducted and the results are assessed against the standard benchmarks that apply to any research.'

Again, the issue is that a researcher getting "unrestricted" research funding, funding that might be keeping his or her academic career alive, might naturally feel some gratitude for the funding, and consequently might unconsciously be less likely to criticize his or her funding source or its products than otherwise. Of course, the more the researcher might need future funding from this sponsor, the more likely would be a conscious sense of obligation to be nice to that sponsor. Furthermore, even "unrestricted" funding may open up some lines of communication between the sponsor and the researcher which the sponsor could use to further increase its influence.

Also, the tobacco companies surely are not spending money to support research out of pure altruism,

'Their interest now is to try to convince the public that they are truly concerned companies and that they care enough to fund important research at reputable institutions,' said Dr. Michael Siegel, a Boston University School of Public Health researcher who has extensively studied the tobacco industry. 'And, they're using the good name of these institutions to try to bolster their own scientific and public credibility.'

That seemed to be working, as demonstrated by this seemingly self-contradictory quote from a Massachusetts Institute of Technology researcher:

'As there were no strings attached in the application process I had no qualms in applying for this funding,' Rami Tzafriri, of MIT, said in an e-mail. 'In retrospect I can say that the whole process was very professional and friendly and that under similar circumstances I would apply for such funding again. Funding for research is essential, but unfortunately scarce. So any source that does not compromise my independence is welcome.'

On the other hand,

'Taking money from the tobacco industry to conduct scientific research is like the DA taking money from the Mafia to conduct investigations of crime,' said Gregory Connolly, a Harvard School of Public Health professor and former director of the Massachusetts Tobacco Control Program.

Indeed. It would strongly be in society's interest to find a way to wean academic medical institutions from their addiction to research dollars proffered by those with something to sell other than science and improving health care.

ADDENDUM (2 April, 2008) - See also comments on the Effect Measure blog.

Saturday, March 29, 2008

Taken for saps in the Trash Industry: Garbage in, garbage out? (Or is it "Garbage Out, No Garbage In?")

If large IT companies can't even get software for hauling garbage correct, why is there so much faith that they can automate healthcare?

While not directly related to healthcare, I see many familiar themes here that I've also seen in healthcare. Could this be the future of enterprise healthcare IT as well? Garbage in, garbage out? (Or is it "Garbage Out, No Garbage In?") Also, since healthcare organizations are choosing this same vendor (including some very prominent ones), this story is of potential importance to our profession.

If the details in this story are even close to factual, SAP would have violated just about every fundamental principle of good software design and resilience engineering, social informatics, and common sense.

I think of stories like these as cautionary tales. They might help counterbalance the mass exuberance regarding complex, expensive enterprise health IT. There certainly are precedents. For example, the essay "Shhhhh! 10 Secrets the EHR Companies Don't Want You to Know" contains familiar themes relevant to the trashy software story below:

SAP sued by trash hauler Waste Management
By Linda Loyd
Philadelphia Inquirer Staff Writer
March 28, 2008

The nation's largest hauler of garbage is suing software developer SAP America Inc., of Newtown Square [PA, near Philadelphia - ed.], and its parent, SAP AG of Germany, alleging fraud and false representations about waste-and-recycling software that it called "a complete failure."

Waste Management Inc., of Houston, is seeking to recover more than $100 million in expenses, plus unspecified punitive damages.

That isn't exactly trash money.

... The suit was filed last week in the Harris County, Texas, District Court. SAP is the world's largest business-software company. Its Americas division employs more than 2,000 in Delaware County.

I wonder how much of SAP America's development and programming work is outsourced to foreign countries (Germany, China, India etc.)? The common belief in this industry, it seems, is that people in foreign lands can be remotely managed in writing extremely complex software for managing extremely complex businesses in other countries (and, in the case of healthcare, entire professions) whose cultures they probably do not understand, since all businesses are just collections of "processes" that can be catalogued and automated like a global Model-T assembly line.

In 2005, Waste Management was looking for new revenue-management software to handle such tasks as billing, collections, pricing and new-customer setup, the lawsuit said.

SAP said its waste-and-recycling software was a "tested, proven, out-of-the-box solution" that could be rapidly implemented without need for any customization, the suit said.

Alert! In this paragraph we see violations of the major tenets of software engineering, resilience engineering, and common sense (common, at least, to anyone not infected with greed and the 'Silver Bullet-based Religion of IT-Enabled Transformation.")

The Waste Management IT personnel who fell for the "Plug and Play" lines should themselves be fired. No complex software is ever "out of the box" when ported from environment A to environment B. To say so, or to believe so, is bull. (In healthcare, that holds even for different medical specialties and service lines even within one organization.)

These representations were false because a "U.S. version" of the software had never been tested at a U.S. company, according to the court filing. Before 2005, it said, the software had been licensed to "a limited number" of small European firms.

And herein is the fatal flaw that is the "wage of hyperconfidence in computers" as all-powerful "solutions" to the world's business and professional problems. Europe, America ... trash hauling is trash hauling, no? Medicine is just a business like any other, right? After all, how hard can it be to accomplish nuclear fission on your kitchen table if you have all the right components?

SAP purported the software would save "hundreds of millions of dollars in increased efficiencies and revenue," the suit said.

Just as similar enterprise software will "revolutionize healthcare?"

Instead, it was "nothing more than beta software - software still in development and utterly incapable of running the operations of an American waste and recycling company," it said.

Waste Management said SAP presented "fake mock-up simulations," although the demonstrations were represented to be the actual software.

Dear Waste Management IT and management personnel,

This is the oldest trick in the book. (I could have smoked this out in ten minutes if you'd let me. Maybe you should have read my website on health IT problems?)

Waste Management said senior SAP executives, including SAP America president and chief executive officer Bill McDermott, participated in the "rigged and manipulated" demonstrations. "These fake product demonstrations occurred at numerous locations and on many occasions during an eight-month time period in 2005," court papers said.

Waste Management signed a licensing pact with SAP on Oct. 3, 2005. "Almost immediately the SAP implementation team discovered significant 'gaps' between the software's actual functionality and Waste Management's business requirements," the complaint said.

"Gaps?" Put more succinctly, it seems the software was garbage. (When something goes wrong, always blame the computer...)

In addition, the suit alleged, SAP originally promised that a pilot phase in New Mexico would be running by Dec. 15, 2006, but "it is not even close to being completed today."

Could this reflect SAP's own "irrational exuberance" about their IT, or was it simply a lie to get a contract signed, real, quality deliverables be damned?

Waste Management said it was seeking recovery of more than $100 million in project expenses "as well as the savings and benefits that the SAP software was promised to deliver."

They may get the former (i.e., money), but lots of luck on getting the latter.

Finally, if anyone on the plaintiff side wants to hire me as a consultant familiar with IT malfunctions and malfeasance, I'm ready and willing.

-- SS

Friday, March 28, 2008

Score One for Research Integrity in the Journals

The latest "HeartWire," a pretty reasonable alerting service from WebMD, heartens us in its account of courts protecting journalistic research integrity over Big Pharma's latest attempts, this time from Pfizer, to wield the meat-axe of the subpoena.

In a Federal district Copurt in Chicago, it seems, Magistrate Judge Arlander Keys ruled that journals--in this case, JAMA--won't have to give up its critical preservation of peer-reviewer confidentiality.

You'll have guessed that this is all about Pfizer's attempts to get out of its Celebrex jam. They wanted nothing less than the actual submitted, including rejected, manuscripts, peer reviewers' identities, and the actual comments passed back and forth between editors and reviewers.

It would have had a chilling effect had this attempt to erode the integrity of the peer review process been even minimally successful. What's chilling too is the fact that Pfizer--or, let's face it, their highly compensated attorneys--could make such a brazen attempt to have a go at the basic trust so necessary to the edifice of research integrity.

What's encouraging, though, is that Judge Keys saw those attempts for what they were.

Thursday, March 27, 2008

What Drug Reps Really Care About

In the Carlat Psychiatry Blog, Dr Daniel Carlat summarized a talk on tactics used by drug representatives by former Eli Lilly rep Shahram Ahari . Some key quotes:
  • "Gift giving is the key. You are programmed as a human to reciprocate. You feel obliged to return the favor."
  • " Samples are a marketing tool. They always have strings attached. Typically, we would provide two weeks worth of samples, which worked out wonderfully. Just like a drug dealer, the first one is free, and then you’re hooked."
  • " We had a $60,000 budget for food, and we used this to make ourselves seem a necessity to clinics who wanted to make their staff happy."
  • "I was in your office in order to influence you to prescribe Prozac or Zyprexa. We focussed on providing information to manipulate your prescribing, not to teach you how to treat your patients. Mostly, we wanted to build a good relationship, so that you’d like us. We are the one spot of sunshine in your day, a person who steps in the door and is actually interested in how you’re doing. We’re fun, witty, attractive, and we come bearing gifts. No wonder we’re accepted into your offices."

Remember, the drup representative's job is to market drugs. He or she is not there to educate the physician. He or she may appear to a beleaguered physician to be the one person who actually cares, but what the drug rep really cares about is selling drugs. He or she is no more naturally the physician's friend than is a hospital administrator or a managed care functionary. Some drug reps are naturally nice people. Some may care about education. Some may really be friends with physician. But they are all trained to appear to be physicians' friends. Physicians uncritically accept this appearance as reality at their and their patients' peril.

Smoked Out: Funding Lung Cancer Screening Research with Tobacco Money

A few weeks ago, we posted about conflicts of interest affecting a widely publicized study of using CT scans to screen for lung cancer. The study, basically a large case-series, was susceptible to multiple kinds of study bias that challenged its validity. Yet its authors used this limited and flawed data to strongly advocate such screening. Two lead study investigators, Dr Claudia Henschke and Dr David Yankelevitz of Weill Medical College of Cornell University, held multiple patents on technology used for the screening, and had licensed one patent to General Electric, a manufacturer of CT scans, and exchanged another for rights in a start-up manufacturer of lung biopsy devices. They did not disclose these conflicts in the articles they published describing study results, including one in the New England Journal of Medicine. We noted that perhaps these conflicts were related to the investigators' great enthusiasm for CT scan based lung cancer screening that went well beyond the data from their study.

Since then, the plot has thickened. A follow up article in the Cancer Letter(1) noted that the New England Journal of Medicine article which failed to disclose the authors' patents and licensing agreement also was a vehicle for continuing medical education (CME). Ethics rules for US CME require full disclosure of all authors' conflicts of interest. Futhermore, the authors had given multiple CME talks. Their disclosure of these conflicts was inconsistent across these talks. Thus, on the GoozNews blog, Merrill Goozner announced that "The Center for Science in the Public Interest later this week will ask the ACCME [Accreditation Council for Continuing Medical Education] to order all the CME providers where Henschke failed to disclose to send proper disclosures to anyone who participated in those activities."

Henschke and Yankelewitz wrote a letter to JAMA in which they acknowledged they had failed to disclose "potential conflicts of interest" in a previous JAMA article and letter.(2) The letter was rather defensive, in my humble opinion, declaring that "The license agreement was between General Electric and Cornell, the institution listed on the title page. A portion of the royalties are distributed to both of us and to the other co-inventors pursuant to Cornell policy, which in turn is consistent with the Bayh-Dole Act." The letter also asserted the authors' very narrow interpretation of conflicts of interest, "we believe that none of the patent applications or the license agreement played any role in the design of the study, interpretation of the data, or drafting of the publications in JAMA and therefore did not disclose them."

A recent AP article noted that even getting to Henschke and Yankelevitz to write this much was not easy.

Dr. Catherine DeAngelis, editor in chief of JAMA, the Journal of the American Medical Association, said she contacted Henschke months ago after others pointed out patents not disclosed in a July 2006 study. DeAngelis said Henschke didn't believe the patents were relevant to the research and resisted disclosing them.

'We'd been working with Dr. Henschke trying to get her to write a letter of apology — which is our policy — and to take responsibility,' DeAngelis said. 'It was not easy to get her to do anything.'

But you ain't seen nothing yet.

This week, Gardiner Harris writing in the New York Times revealed that the same study which was reported in the New England Journal of Medicine article(3), was substantially funded by money from a tobacco company.

Small print at the end of the study, published in The New England Journal of Medicine, noted that it had been financed in part by a little-known charity called the Foundation for Lung Cancer: Early Detection, Prevention & Treatment. A review of tax records by The New York Times shows that the foundation was underwritten almost entirely by $3.6 million in grants from the parent company of the Liggett Group, maker of Liggett Select, Eve, Grand Prix, Quest and Pyramid cigarette brands [Vector Group Ltd].

Moreover, Henschke and Yankelevitz could hardly deny knowing about this source of their funding. They were the ones running the foundation.

Dr. Henschke was the foundation president, and her longtime collaborator, Dr. David Yankelevitz, was its secretary-treasurer.

It turns out that the leadership of Weill Medical College of Cornell University were in on this.

Dr. Antonio Gotto, dean of Weill Cornell, and Arthur J. Mahon, vice chairman of the college board of overseers, were directors.

The Cornell leadership denied that the intent was hiding tobacco money. On the other hand, the purpose of the foundation, other than to serve as a conduit for this money to the research project, was not exactly clear.

In an e-mail message, Drs. Henschke and Yankelevitz wrote, 'It seems clear that you are trying to suggest that Cornell was trying to conceal this gift, which is entirely false.'

'The gift was announced publicly, the advocacy and public health community knew about it, it is quite easy to look it up on the Internet, its board has independent Cornell faculty on it, and it was fully disclosed to grant funding organizations,' they wrote, adding that the Vector grant represented a small part of the study’s overall cost. The foundation no longer accepts grants from tobacco companies, they wrote.

In the Vector press release, Dr. Henschke was quoted as saying that, thanks to the Vector grants, 'we have raised the initial funding needed to support this important research and data collection on the effectiveness of spiral CT screening.'

Dr. Gotto said in an interview that Dr. Henschke, Dr. Yankelevitz and another colleague set up the foundation initially without the university’s approval, which he said faculty members are allowed to do. He and Mr. Mahon joined the board some weeks or months after its creation to ensure that the Vector grants were handled correctly, he said.

'If we had been approached, we would not have set up the foundation,' Dr. Gotto said. 'We would have accepted the gift directly. We think we behaved honorably. There was no attempt to set up a foundation to hide tobacco money.'

Days earlier, Andrew Ben Ami, assistant secretary of the foundation, said in an interview he would not disclose the source of the charity’s financing at the request of the university.

In another interview before Dr. Gotto agreed to speak, Mr. Mahon, another foundation director, said he did not know the source of the funds.

Note that the Foundation for Lung Cancer: Early Detection, Prevention, & Treatment seems quite obscure. It has no web-site. Its address and email address, as reported by SourceWatch, are for Dr Henschke's office. What it has done other than transfer tobacco money to the research project is unknown.

You just can't make this stuff up.

So we have yet another case which illustrates how pervasive is the web of conflicts of interest that entangles physicians, researchers, academic medical institutions, and industry. Moreover, the web increasingly appears to involve not only industries that make products meant to do patients more good than harm, that is drugs and medical devices, but also industries whose products have no medical use, and even now tobacco, certainly one of the major man-made health scourges.

So this case has actually produced some outrage. Per the New York Times article,

Prominent cancer researchers and journal editors, told of the foundation by The Times, said they were stunned to learn of Dr. Henschke’s association with Liggett. Cigarette makers are so reviled among cancer advocates and researchers that any association with the industry can taint researchers and bar their work from being published.

'If you’re using blood money, you need to tell people you’re using blood money,' said Dr. Otis Brawley, chief medical officer of the American Cancer Society. The society gave Dr. Henschke more than $100,000 in grants from 2004 to 2007, money it would not have provided had it known of Liggett’s grants, Dr. Brawley said.


Dr. Jerome Kassirer, a former editor of The New England Journal of Medicine and the author of a book about conflicts of interest, said he believed that Weill Cornell had created the foundation to hide its receipt of money from a cigarette company. 'You have to ask yourself the question, ‘Why did the tobacco company want to support her research?’' Dr. Kassirer said. 'They want to show that lung cancer is not so bad as everybody thinks because screening can save people; and that’s outrageous.'

The case also illustrates the messiness of relationships among researchers, academic medical leaders, and industry. As Gardiner Harris wrote in the NY Times,

Universities are responsible for policing conflicts of interest and, in many cases, the required disclosures of their faculty. But Weill Cornell shared in the proceeds of Dr. Henschke’s patent and pending patents, and university officials were on the foundation board.

'We have a very strict oversight policy' for conflicts of interest, Dr. Gotto of Weill Cornell said. He dismissed any suggestion that the university could not police and benefit from faculty members’ financial deals.

But Dr. Kassirer said, 'The problem is that universities, because they’re so conflicted themselves, ignore the conflicts of interest of their faculty.'

To illustrate Dr Kassirer's last point, a quick Google search revealed that Dr Gotto, in addition to being dean of the medical school, is a top leader of two pharmaceutical companies. He is on the board of directors of Aegerion Pharmaceuticals and of Arisaph Pharmaceuticals. So where do his interests lie? - promoting the integrity of the medical school, promoting more funding to the medical school, promoting the profits of these two companies, or promoting the interests of the power elite who simultaneously can run medical schools and run health care corporations? Who can tell?

And that is, as we have said before, the curse of conflicts of interest in health care. Conflicts lead to confused thought, speech, and action. One cannot tell what interests lie behind the speech and actions of the conflicted. So clinical research designed, implemented, analyzed, and discussed by the conflicted rather than leading to further clarity about how to care for patients, just leaves us in a fog of doubt.

But financial ties to various industries, regardless of the conflicts they produce, fuel academic medical institutions and universities who want their faculty to become "taxpayers" rather than teachers and researchers (see post here). Such funding may be one reason why administrators now outnumber faculty in higher educational institutions. Such funding fuels the imperial pretensions of their leadership (see post here). So the universities will not give up their conflicts without quite a fight. But it's time for that fight to start.

ADDENDUM (28 March, 2008) - See also comments by Merrill Goozner on Gooznews, and by Gary Schwitzer on the Schwitzer Health News Blog.


1. Goldberg P. NEJM says Henschke conflicts irrelevant; propriety of granting CME questioned. Cancer Letter 2008; 34: 1.
2. Henschke CI, Yankelevitz DF. Unreported financial disclosures. JAMA 2008. (Link here.)
3. The International Early Lung Cancer Action Program Investigators. Survival of patients with stage I lung cancer detected on CT screening. N Engl J Med 2006; 355: 1763-1771. (Link here.)

Wednesday, March 26, 2008

Baxter Executives and the Syndrome of Overconfidence in a Chinese Pigsty

At various posts on Baxter's contaminated heparin, Roy Poses makes a number of good points. I will amplify one I consider crucial, and perhaps sentinel:

Yet Baxter International executives have not exactly been jumping forward to claim responsibility. In a letter, again to the Chicago Tribune, Peter J Arduini, President, Medication Delivery, for Baxter International seemed to be deflecting responsibility towards Scientific Protein Laboratories and the FDA, while asserting Baxter did all it could do.

How could Arduini know "Baxter did all it could do" to assure the quality of a complex biological?

Note his corporate bio below. Anything missing? How about:

A scientific background - such as in chemistry, biology, pharmacology, biomedicine, fields like that? Maybe a BA, or better yet, an MS, or how about ... a PhD in some scientific area?

He seems to have no personal knowledge or professional credentials that would permit him to understand the fine points of drug/biological manufacturing and purity.

However, by his executive position he held the ultimate responsibility to understand and act on this issue, and in my opinion should face the consequences of that responsibility. From my perspective (and not just a personal one; I was once Director of the team that authors The Merck Index of Chemicals, Drugs and Biologicals), the following questions should be asked:

  • Were there complaints from people with a science background at Baxter about the risks of acquiring heparin ingredients from fuzzy Chinese sources, that were ignored or even punished?
  • Why was someone with no biomedical background in such a position?
  • As President, Medication Delivery, what does Arduini's employment contract state with regard to his responsibilities to assure drug quality and purity?
  • If his job description includes that function, why is he not being held accountable?
  • If his job description does not include issues of product quality and purity, then why not, and ... whose does?
  • What was the role of the Baxter Board of Directors in setting professional and educational criteria for top executives responsible for drugs and biologicals?
  • Did Board members have any conflicts of interest regarding such matters?

Once again, it seems we have at the very least a management expertise problem, as pointed out in many stories on HCRenewal:

Peter J. Arduini is corporate vice president of Baxter Healthcare Corporation and president of the company's Medication Delivery business .

Prior to joining Baxter in March 2005, Mr. Arduini served as global general manager of General Electric Healthcare ' s cat scan (CT) and functional imaging business, a $2 billion capital equipment and innovation-intensive business. Mr. Arduini spent 15 years at General Electric Healthcare in a variety of management roles for domestic and global businesses. In addition to having served in sales management there, he also oversaw marketing, market research, product design and engineering program development for its radiology and cardiology franchise. Prior to joining General Electric Healthcare, Mr. Arduini spent four years with Procter & Gamble.

Mr. Arduini received his bachelor's degree in marketing from Susquehanna University and a master's in management from Northwestern University's Kellogg School of Management.

Regarding simple common sense, let alone scientific credentials:

Considering the low quality of much of the electronics I buy stamped "Made in China", where I usually buy two of everything (so I can return the one that's broken right out of the box), I'd say the Baxter execs should have been suspicious by default about the heparin ingredients. Suspicious with regard not just to adulteration and counterfeiting (which China seems excellent at - think CD's and designer watches), but to basic impurities, period.

After all, these came not from a foreign electronics company, but from a foreign pigsty.

That is not exactly a place that inspires my confidence regarding medication purity issues.

If I had been that President for Medication Delivery, I'd have set up the most rigorous, analytical chemistry-based and on-site inspection quality assurance program from the get-go. I'd have refused to outsource to China without that. To hell with FDA.

However, that awareness requires two things: brains, along with the appropriate scientific education and expertise (to realize the need), and money (which cuts profits.)

I am tired of the "leadership by biomedical dilettante" that plagues healthcare. Baxter's senior executives and Board deserve to be sued in my opinion by those harmed. Such devastating lawsuits will send a needed corrective message.

I also extend an offer of my knowledge and services to plaintiff's attorneys in that regard.

-- SS

Contaminated Heparin: Where is the Outrage?

We have posted frequently on the case of the contaminated heparin. A summary to date is below.

  • We have posted several times, recently here and here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events in the US was made by Baxter International.
  • We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. The company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart.
  • Most recently, we found out that the Baxter International labelled heparin was contaminated with over-sulfated chondroitin sulfate, a substance not found in nature, but which mimics heparin according to the simple laboratory tests used in the Chinese facilities to check incoming heparin. (See post here.) Further testing revealed that the contamination seemed to have taken place in China prior to the provision of the heparin to Changzhou SPL. (See post here.) It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there.
  • The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops."

Although this case has been extensively covered by some major newspapers, with kudos going to the Chicago Tribune, New York Times, and Wall Street Journal (in alphabetical order), the story has inspired, in my humble opinion, very little commentary, and that commentary has been remarkably reticent. This week, though, some interesting points were raised in the blogsphere.

On the PharmaLot blog, Ed Silverman interviewed personal injury attorney Eric Turkewitz, who undoubtedly had some of his own axes to grind. Nonetheless, he made some points that others have not.

  • Baxter International could be in serious legal trouble - "Assuming the reports are true. Baxter sold a counterfeit drug, which is in violation of federal law. We lawyers like to call it ‘negligence per se.’ They had an obligation to verify the goods they sold are bona fide. But it appears that Baxter sold something different." Furthermore, "They have an obligation to make sure the stuff they’re selling is what they say it is. They’re the ones selling the product."
  • Baxter International executives ought to have known that deliberate counterfeiting was a potential source of contamination - "I think it’s impossible for anybody to say, with a straight face, that they’re taken by surprise by what’s happened. The dangers of counterfeiting, because of the vast sums of money at stake, are well known in the pharmaceutical industry. And one aspect of that problem is counterfeit ingredients in the production process as opposed to a counterfeit finished product that enters the supply chain in the US and is mixed in with a legitimate shipment or sold as a substitute. This is the issue with the production in China. It’s called foreseeable risk. For Baxter, I don’t know if (the sourcing) was a decision to save money or they had to look for another supplier. But whatever the reason they used this supplier, they can’t excuse it. I can’t think of any excuse (Baxter) can come up with that will hold water."

Also, Nancy Reyes, described as a retired physician living in the rural Philippines, made some points on the Blogger News Network about what commentary there has been about the case.

  • The commentary seemed to assume that the problem was due to accidental contamination, not deliberate counterfeiting - "The problem is that too many American newspapers are writing editorials as if this was merely a quality control problem that FDA inspections would eliminate." However, "The drug was deliberately diluted with a drug that would pass routine drug testing.
  • The suggested solution, more inspections, could be evaded by people who deliberately seek to sell counterfeit drugs - "Inspections won’t work. You need a full time watchdog…one who won’t accept a bribe…" Furthermore, inspections "assume honesty. But would an honest man go out of their way to find a drug that is cheap and would pass routine tests? Obviously not. And if they cheat in big things, what makes you think that the labels and paper work would be honest?" In summary, "To think that simple inspections will find the hidden corruption that allows such deliberate contamination is naive. The criminals will merely find another way to outwit the inspectors to make money. If there is to be inspections, could I suggest that the ones to do such inspections should include FBI agents familiar with organized crime?"

It seems to me that the public discourse about this case has been strangely reticent. After all, after getting intravenous heparin, patients died, and many patients got very sick. So where is the outrage? Instead, the problem seems to be discussed as if it were a natural disaster or an innocent accident, which could not have been prevented, and for which no one was to blame.

What criticism there has been was of the US Food and Drug Administration for its inadequate inspections of outsourced drug suppliers. With the exception of the interview above, there has been little criticism of the US companies who sold drugs without paying much attention to how they were produced.

Finally, almost nothing has been heard from physicians (with the recent exception of Dr Reyes). In my extensive file on this case, I have found no other commentaries written by physicians, in newspapers, and certainly not in medical journals. Maybe it just takes a long time for such things to get published.

Yet, physicians' prime obligation is to put their patients' interests first. Presumably many well-meaning physicians gave heparin to their patients assuming it was safe, pure, and more likely to do more good than harm, only to see some of them sicken, and a few die. One would think physicians would be hopping mad to find out the drug they trusted was not really made by the venerable drug company whose label adorned it, that it was really made in unknown Chinese "workshops," and was apparently deliberately contaminated long before it got to the US.

Maybe physicians are so deep into a state of learned helplessness, or so fearful of company lawyers waving SLAPPs that they can't or won't express outrage. But if we don't get mad when bad things happen, more and more bad things will happen. It is our role as physicians to stand up for our patients. So the least we can do is express our outrage when the drugs we prescribe for them turn out to be contaminated and counterfeit.

So let me say it: This case is outrageous. It demands not only a scientific, but a criminal investigation. Any people identified as responsible for contaminating the heparin, and responsible for selling the contaminated heparin without making adequate attempts to assure its purity, should be prosecuted. The negative incentives for counterfeiting drugs, and for selling drugs likely to be contaminated without adequately assessing their purity should be so strong that no one in their right mind would dare to do this again.

Tuesday, March 25, 2008

BLOGSCAN - Continuing Investigation of Orthopods' Financial Relationships with Prosthetic Joint Manufacturers

On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody expanded his focus a bit to include medical device companies. He posted about the ongoing investigations of orthopedic surgeons' financial relationships to the manufacturers of prosthetic joints. He cited an unnamed senior general surgeon who "did not think that anywhere near as much real 'consulting' ever got done as cash flowed into docs' pockets." This story keeps bubbling just below the surface. Stay tuned, as I suspect there will be more developments.

BLOGSCAN - Imperial Pharmaceutical CEOs

On the PharmaLot blog, Ed Silverman has two posts about how pharmaceutical executives continue to rake in humongous compensation whose magnitude seems unrelated to their performance or the performance of their companies. The CEO of Cephalon got more than $15.8 million, including the value of stock options, while the company is dealing with an Federal Trade Commission lawsuit which contends the company blocked sales of a generic competitor, and despite settling a suit about off-label marketing (see post here.) The CEO of Bristol-Myers-Squibb got $13.5 million after the company's stock price fell, the company took a charge for losses on sub-prime mortgages, and several top financial officers left (see post here.) Again, as we noted earlier, imperial CEOs seem rampant in health care organizations.

Friday, March 21, 2008

Who Was Responsible for the Purity of Baxter International's Heparin?

We have posted several times, most recently here and here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions.

All the heparin related to these events was made by Baxter International. We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. In fact, the company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart. Most recently, we found out that the Baxter International labelled heparin was contaminated with over-sulfated chondroitin sulfate, a substance not found in nature, but which mimics heparin according to the simple laboratory tests used in the Chinese facilities to check incoming heparin. (See post here.)

It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there. The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops."

By the end of this week, it became clear that the counterfeit ingredient was added to the heparin in China. Per Bloomberg,

The contamination was present in the powdered raw heparin purchased by Scientific Protein's plant in China, said Robert Rhoades, a pharmaceutical consultant with Becker & Associates in Washington, speaking for Scientific Protein. The company was unaware of the contamination at the time because it wasn't detected in tests Scientific Protein conducted on the powder provided by suppliers, he said.

Scientific Protein purchased raw heparin from consolidators and refined it further before sending it to Baxter, which uses the ingredient to make the finished drug, Rhoades said. The consolidators obtained the ingredients from workshops in China, he said.

The contaminant 'was very likely introduced at the workshop or consolidator level,' Norbert Riedel, Baxter's corporate vice president and chief scientific officer, has said.

Nonetheless, a number of experts suggested that there was reason not be complacent about drugs made in China. A Washington Post article noted that it was well known that Chinese manufacturers were liable to supply dodgy drugs,

Although the contaminated heparin is the largest and highest-profile instance of tainted prescription drugs made in China, it is not the first. In the late 1990s, a spike in deaths associated with the intravenous antibiotic gentamicin was linked to China-based Long March Pharmaceuticals. Although no definitive link was ever established, tests by German researchers later found a wide range in quality and effectiveness in what were supposed to be uniform dosages of the drug, leading them to write that 'it was assumed' the deaths 'were related to faulty manufacture.'

The Post quoted former US Food and Drug Administration (FDA) official William Hubbard,

The history of some of these developing countries in terms of substituting or counterfeiting concerns is a long and well-documented one....

USA Today quoted former FDA Commissioner David Kessler saying that

the news shouldn't come as a surprise: China is 'as close to an unregulated environment as you can get.' In fact, it's a lot like the USA was in 1906, he says —'that's why we developed an FDA.'

Furthermore, one expert argued that Baxter International was ultimately responsible for the drug that it sold, per the Chicago Tribune,

The presence of a foreign ingredient raises new questions about Baxter's oversight because a lack of record-keeping at the China plant makes it more difficult for Baxter and government inspectors to trace the origin of the raw material for Baxter's product.

'Where are the controls here? What is the process here?' asked Carl Nielsen, who was the FDA's director of import operations and policy before leaving the agency to form a consulting firm in 2005.

'Ultimately, Baxter is the most responsible' for monitoring the quality of products that move through the company's pipeline, Nielsen said.

Yet Baxter International executives have not exactly been jumping forward to claim responsibility. In a letter, again to the Chicago Tribune, Peter J Arduini, President, Medication Delivery, for Baxter International seemed to be deflecting responsibility towards Scientific Protein Laboratories and the FDA, while asserting Baxter did all it could do.

Regarding the issue of active pharmaceutical ingredient that originated in China, Baxter's API supplier for heparin is in fact a Wisconsin-based company, Scientific Protein Laboratories, with whom Baxter and its predecessor in this business has worked for more than 30 years. SPL had been procuring heparin raw material from China for more than 10 years and opened a location in Changzhou, China, in 2004. Baxter worked with the U.S. Food and Drug Administration to obtain the appropriate approvals to work with this facility. For the API we receive from SPL, and for the API we receive from all our suppliers, Baxter performs quality testing of all incoming materials above and beyond what's required, to ensure that incoming API is what our suppliers claim it to be. Unfortunately, as the FDA has said, the problematic heparin API could not have been detected by the testing required of and done by any heparin manufacturer.
Previously Baxter International's CEO, Robert L Parkinson Jr, had dodged responsibility for the supply chain that provided the heparin to Scientific Protein Research's Changzhou facility, as we posted here, and as originally reported in the Chicago Tribune,

Baxter International Inc. does not monitor its supply chain to the extent that it would know that a supplier in China was never inspected before it began shipment of the blood-thinning drug heparin, which is linked to more than 300 illnesses in the U.S., the company's chief executive said Wednesday.

Baxter contracted with a Wisconsin supplier, Scientific Protein Laboratories, and not with that company's Chinese affiliate, Baxter CEO Robert Parkinson said Wednesday in his first interview since the heparin problems surfaced.

'It's not unusual for us not to know that the FDA hasn't inspected a supplier to a supplier,' Parkinson said.

Yet if Baxter International is not responsible for the production of drugs that carry its name, who is? If Baxter International's executives are not responsible for how the drugs it sells are manufactured, who should be?

In an ironic juxtaposition, a small and little noticed news item last week declared that Robert Parkinson received $16,600,000 in compensation in 2007, a 30.5% increase from 2006. In fact, the company's 2008 proxy statement suggests even greater total compensation in 2007, $17,580,718. And Mr Arduini's 2007 compensation was reported to be $2,438,642.

The usual justification for compensation at this level is the brilliance of and great responsibilities borne by the executives who receive it. But, if Baxter International's executives will not take responsibility for their products and how they are made, what again is the justification for paying them the big bucks?

So the case of the contaminated heparin becomes another reason to question the imperial nature of the current leadership of health care organizations.

BLOGSCAN - Labor Union Helps to Market Lipitor

In the Health Beat Blog, Maggie Mahar discussed how a branch of a labor union, the International Association of EMTS and Paramedics, an affiliate of The National Association of Government Employees (IAEP/SEIU), has been helping to market Lipitor (atorvastatin, by Pfizer Inc). I am not sure I have heard of previous cases of labor unions enlisted in stealth marketing efforts by pharmaceutical companies. Ms Mahar so far has not been able to elicit a coherent explanation from the union. Thanks to Dr Alicia Fernandez for blowing the whistle on this on. This also has been re-posted on the GoozNews blog. Although I have not previously heard of a case in which a labor union was helping to market a drug manufactured by a big pharmaceutical company, this is but one of many, many examples we have seen of reputable organizations taken in directions at odds with their missions by leaders with their own agendas.

Wednesday, March 19, 2008

Fake Heparin, then Sick and Dead Patients

We have posted several times, most recently here, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions. All the heparin related to these events was made by Baxter International.

We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. In fact, the company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart.

It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there. The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops."

Now the US FDA just reported it identified a contaminant in the heparin that may be responsible for the adverse reactions. This has already been reported today by many media outlets, but I will quote Bloomberg since its article makes the main points most concisely,

Baxter International Inc.'s blood thinner heparin, linked to deaths and allergic reactions, was contaminated with a less-expensive ingredient derived from animal cartilage, U.S. regulators said.

The contaminant, over-sulfated chondroitin sulfate, isn't approved for use in medicine, said Janet Woodcock, the head of the Food and Drug Administration's drug division, in a conference call today with reporters. Regulators are investigating whether the substance was intentionally or accidentally added to raw heparin from China.

'It does not appear to have come straight from the pig,' Woodcock said of the contaminant. 'It doesn't appear to be a natural contaminant that got in there. We don't know how it was introduced or why.'

Adding the contaminant to raw heparin, the active ingredient in the finished product, would have been cheaper than using pure raw heparin, according to the FDA. The agency didn't know how much money would be saved by its use, Woodcock said.

Chondroitin sulfate is taken orally as a dietary supplement to treat joint pain. The over-sulfated version found in the heparin was chemically modified to act like heparin, Woodcock said.

Over-sulfated chondroitin sulfate is generated in laboratories for experimental purposes, said Siobhan DeLancey, an FDA spokeswoman, in an interview. It is chemically altered to add additional sulfates, she said.

Two percent to 50 percent of the contaminated raw heparin samples tested by the FDA were made up of over-sulfated chondroitin sulfate, Woodcock said.

So it now appears, although it is not yet proven that the adverse reactions and deaths were caused not by a trace contaminant derived from a sloppy, primitive, and unsanitary manufacturing process, but from a bulk counterfeit ingredient deliberately introduced because it was cheaper than heparin, yet would fool purchasers into thinking it was heparin.

Thus we see what happens when US health care leaders were happy to put their prestigious logo on a drug whose source was unknown to them, presumably just to save some money. By obviously failing to exert rigorous oversight over how the drug which carried their company's name was produced, they not only allowed sloppy, primitive and unsanitary manufacturing practices, but apparently were easily snookered by counterfeiters who substituted a likely toxic ingredient for the real thing.

This was putting profits before patients. And the results were very bad for patients.

Baxter claims to apply
its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.

However, rather than its expertise, its sloppy and uncaring leadership seemed to leave some of its patients' lives meaningfully worse.

This case is a glaring demonstration of why we need a new set of leaders of our health care organizations, and a new corporate culture within these organizations. Otherwise, failing to understand the health care context, and failing to put patients before profits will yield more sick and dead patients.

The wages of complacency in defining "Medical Informatics" as a specialty

Over recent months I’ve been exploring roles back in applied HIT, having been a CMIO (Medical Director of IT, now called "Chief Medical Informatics Officer") in decidedly applied settings in the “olden days” a decade ago.

One common feature of the conversations I’ve had was that I’ve left these interviews with a sense of unease and annoyance, but was unclear why. It is only recently that I’ve been able to identify a common theme.

Imagine a seasoned neurosurgeon, interviewing for department chair, in the following interview scenario:

Candidate: I’m here interviewing for chair of the department of neurosurgery.

CIO: Well, you have an interesting background and have done many varied things. Were you aware that it’s important to be able to bring doctors into consensus? Tell us about how you intend to do that. Have you ever brought doctors into consensus?

IT project leader: How would you deal with pharma detail people? I don’t see that on your resume.

Finance: Billing is important. From your background, I’m not sure you understand billing. Tell us about your experience in that area.

Other doc: How would you go about treating meningitis? Can you actually do that? Have you ever done an LP?

While the scenario is absurdist, in effect I believe it summarizes metaphorically what I’ve been experiencing.

The hospital interviews I’ve been having are unlike anything I experienced in seeking clinical roles. They have even been a significant step down from some of the difficult ones I’ve had in pharma, where at least there is an understanding that holding an MD/Informatics title means the person understands something about biomedical research and computing.

In other words, I find that the designation of having studied Medical Informatics seems to confer no “fides” on a leadership role in applied Health IT (HIT) in hospitals. I’ve found myself interrogated about abilities and accomplishments in HIT as if “Medical Informatics” was being parsed as “Hsfapfwllerw”, i.e., meaningless, and as if past accomplishments were imagined or exaggerated. I find line items on a resume that say “led difficult HIT projects, managed staff, managed budgets” seem to mean little or are negated under the umbrella of the “Medical Informatics” title.

I find myself being asked frivolous questions on fundamental issues to which my reply really should be:

“Have you actually read my resume? Do you know what medical informatics is, and have you bothered to look before this interview?”

I’ve been preached to and patronized about HIT project issues by IT personnel and other non-clinical personnel, based upon what they seem to have read in their throwaway journals (e.g. “Advance for Health Information Executives”), as if I didn’t know anything about the area; as if IT staff were the clinical IT experts and I, an intern.

Another common finding is that materials I provide both pre- and post-interview on Medical Informatics (e.g., web links to my sites) are largely ignored, as I track my web sites by IP and can see from where they’re being read - or not.

Interviews of seasoned professionals in well-understood domains should not be like this. In my role interviewing doctoral-level faculty candidates for my college, we never, for example, asked them or challenged them if they understood basic tenets of information/library science, as if they were undergraduates. To do so would have been both unthinkable and alienating. Instead, we sought to have candidates tell us about their specific areas of expertise and how that could fit our needs. The assumption was that by being invited, we understood they were a competent professional.

Yet in medical informatics I’ve started to dread interviews, due to the absurdist scenario above, the need to present myself as someone who "gets it" regarding HIT, and the need to provide remedial education in an interview setting to confused people.

The weaknesses in societal understanding of the term “Medical Informatics”, therefore, are unhelpful to people who’ve expended the time and treasure acquiring the credentials and who wish to work in applied HIT.

This phenomenon impairs the ability of the Medical Informatics profession to contribute to and steer HIT in the service of medicine, and to help healthcare organizations avoid commonplace, expensive errors regarding clinical IT projects they can ill afford.

I am assuming this phenomenon is not just part of a larger phenomenon of dumbing-down in healthcare, of cost-cutting and institutionalized mediocrity.

This really needs to change.

-- SS

Tuesday, March 18, 2008

The Peril to Leaders "Who Accept Their Own Myth"

In the Washington Post, E J Dionne wrote about the recent collapse of the sub-prime mortgage market, and near collapse of at least one prominent investment banking firm, but what he wrote was also highly relevant to how US health care currently operates (I realize that some of Dionne's opinions may have an ideological slant, but I believe the point goes beyond the usual left/right dichotomy).

Never do I want to hear again from my conservative friends about how brilliant capitalists are, how much they deserve their seven-figure salaries and how government should keep its hands off the private economy.

The Wall Street titans have turned into a bunch of welfare clients. They are desperate to be bailed out by government from their own incompetence, and from the deregulatory regime for which they lobbied so hard. They have lost "confidence" in each other, you see, because none of these oh-so-wise captains of the universe have any idea what kinds of devalued securities sit in one another's portfolios.

So they have stopped investing. The biggest, most respected investment firms threaten to come crashing down.

But if this near meltdown of capitalism doesn't encourage a lot of people to question the principles they have carried in their heads for the past three decades or so, nothing will.

We had already learned the hard way -- in the crash of 1929 and the Depression that followed -- that capitalism is quite capable of running off the rails. Franklin Roosevelt's New Deal was a response to the failure of the geniuses of finance (and their defenders in the economics profession) to realize what was happening or to fix it in time.

As the economist John Kenneth Galbraith noted of the era leading up to the Depression, "The threat to men of great dignity, privilege and pretense is not from the radicals they revile; it is from accepting their own myth. Exposure to reality remains the nemesis of the great -- a little understood thing."

But in the enthusiasm for deregulation that took root in the late 1970s, flowered in the Reagan era and reached its apogee in the second Bush years, we forgot the lesson that government needs to keep a careful watch on what capitalists do. Of course, some deregulation can be salutary, and the market system is, on balance, a wondrous instrument -- when it works. But the free market is just that: an instrument, not a principle.

In the last 20 years, for-profit health care corporations seem to have turned their leaders into imperial CEOs. Their organizational cultures have been turned into cults of personality extolling the wisdom of their fearless leaders. Such brilliant leaders of course deserved equally brilliant compensation. So there have been plenty of CEOs of for-profit health care corporations who have had seven-figure-plus compensation. But sometimes, that compensation seemed not very proportional to their competence. (Remember the examples of the "brilliant" former CEO of UnitedHealth, or the former CEO of Pfizer Inc.)

Furthermore, the leaders of not-for-profit health care organizations have also become objects of personality cults, which suggested that they too deserved lavish, often seven-figure salaries and to live the high life at the expense of organizations whose missions are ostensibly to treat disease and reduce suffering, and/or to train students and pursue science. (See our latest example of the leaders of the University of Texas Southwestern Medical Center.)

We have often suggested that leaders who are more focused on their own wealth, power, and privilege may not be good at improving patient care, or advancing academic medicine.

So let us quote Galbraith again, and remember what he said applies well to leaders of health care organizations.

The threat to men of great dignity, privilege and pretense is not from the radicals they revile; it is from accepting their own myth. Exposure to reality remains the nemesis of the great -- a little understood thing.
Far too many leaders of health care have accepted their own myth. Thus it is likely that all too soon, some important part of the health care system will come crashing down like Bear Stearns unless health care professionals and patients can shred these myths in time.

A big hat tip to Dr Peter Rost on the Question Authority Blog.

Monday, March 17, 2008

Living the High Life in Academic Medical Center Leadership

We had posted awhile back about how a not-for-profit, state supported academic medical center, University of Texas- Southwestern Medical Center, had created an "A list" of local notables who were to be given special treatment, including enhanced access to physicians. This seemed to imply some slippage from the institution's mission (see post here). It turned out that the practice may not be unique, but neither is is universal (see this post).

The local television station that uncovered this practice, "CBS 11," has been keeping an eye on the medical center. Late last year it found out its top officials had quite a taste for expensive wine.

Top state officials at the University of Texas Southwestern Medical Center in Dallas spent tens of thousands of dollars in donations on luxury wines from prestigious New York wine merchants.

A CBS 11 News investigation of charges to the university's credit cards found that President, Dr. Kern Wildenthal, and his right hand assistant, Vice President, Cyndi Bassel, spent more than $125,000 on wine.

A UT Southwestern spokesman says the state healthcare institution purchased the wine with money from unrestricted donations and not tax funds. John Walls explained the wine expenses in a written statement, 'The purchases from New York dealers were for hard-to-find wines not readily available in local retail shops, which were especially appropriate for individual commemorative gifts and special recognition events.'

The TV station's reporters also found that the Medical Center was using restricted donated funds to wine and dine its top executives, although the funds were meant for very different purposes.

Upon his death in 1986, [Jesse] Brittain left his life savings of more than $390,000 to UT Southwestern. Brittain's endowment agreement specified that the money was to be used 'for the sole purpose of enhancing the business operation of UT Southwestern giving priority to the professional development of personnel in the business operation, including training courses, books, seminars, etc.'


CBS 11's hidden camera was there to record how the state university has been using money from the Jesse Brittain Memorial Fund.

The family of the late donor says the money was intended to help train employees and not for what CBS 11's investigation found.

The undercover video captured an annual holiday party held for a select group of the university's business administrators.

The state officials gathered in a luxurious penthouse dining room on the University's North Campus. It is a rarified atmosphere with a half million dollar collection of sleek tables designed by the internationally recognized Spanish architect Santiago Calatrava and a breathtaking night vista of twinkling lights on the Dallas skyline.

A white jacketed chef carved slices of herb crusted sirloin from a $450 side of beef. A waiter strolled through the party serving risotto crab cakes that cost $316 and artichoke hearts filled with goat cheese that cost $316.

Tables of silver serving trays filled with specialty appetizers were decorated with large gingerbread houses.

Partygoers bellied up to an open bar where more than $1000 worth of drinks were served.

The party that CBS 11 found in full swing is one of three annual holiday parties that have been paid for with more than $15,000 from the Jesse Brittain Memorial Fund.

In general,

CBS 11's review of financial records obtained under the Public Information Act indicates that more than $40,000 was spent on meals and refreshments which were paid for with money from Brittain's Memorial Fund over the past two years.

Finally, CBS 11 documented how the Medical Center CEO was living high on the hog supported by tax-exempt donations.

Dr. Kern Wildenthal, the President of the University of Texas Southwestern Medical Center in Dallas, spent tens of thousands of donors' dollars on European trips, meals at five star restaurants, parties and expensive gifts, according to CBS 11's review of the state university's records.

CBS 11 uncovered more than $500,000 in expenses charged over the past two years to credit cards issued to Wildenthal and Cynthia Bassel, UTSW's Executive Vice President for External Relations. Financial records obtained under the Public Information Act indicate that most of the expenses were paid for with money that was donated to the medical institution.

The Southwestern Medical Foundation, the university's fundraising arm, paid for the bulk of the credit card expenses including:
--$533 for a donor dinner at a five star restaurant at the Hotel Meurice in Paris, France, for Wildenthal, his wife Margaret, British opera singer Robert Lloyd and his spouse and Andre Dunstetter, a Parisian social figure with ties to Dallas.
--$783 for Wildenthal's two most recent annual memberships in Mosimann's Dining Club, an exclusive restaurant in London.
--$459 for collectible Woodland Eagle dinnerware, including a platter and four mugs from Crow's Nest Trading Company, for two donors in April of 2007.
--$13,000 for tulip arrangements sent to donors for Valentine's Day over the past two years. A note on the 2007 order instructs the florist to deliver a half-dozen of the arrangements to Wildenthal's home.
etc, etc, etc


Both Wildenthal and Bassel have charged thousands of dollars to the credit cards for memberships in social and civic organizations. CBS 11's review found that donors' money from the Southwestern Medical Foundation was used to pay for Wildenthal's 2007 membership dues in the Dallas Symphony ($3500); Dallas Museum of Art ($5000); Nasher Sculpture Garden ($5000); British North American Committee ($6000); Dallas Women's Club ($850); and the SMU Town and Gown Club ($140).

As we noted earlier, the UT Southwestern mission statement is [with italics added for emphasis]:

* To improve health care in our community, Texas, our nation, and the world through innovation and education.
* To educate the next generation of leaders in patient care, biomedical science and disease prevention.
* To conduct high-impact, internationally recognized research.
* To deliver patient care that brings UT Southwestern's scientific advances to the bedside — focusing on quality, safety and service.

Somehow, I don't see anything about fancy wines, opulent dinners, and luxurious trips for the top leaders.

Once again, it appears that the leaders of large health care organizations fancy themselves different from you and me. They seem to feel entitled to membership in the power elite, to lead the high life (and not the version from a Miller beer commercial) while leading organizations that are supposed to focus instead on the community and to bring quality care to all patients' bedsides. I have no objection to good pay for people who work hard on behalf of the mission. But it is unseemly for leaders of not-for-profit health care organizations to live like minor nobility while so many health care needs remain unmet.

By the way, it may not be that what the University of Texas - Southwestern Medical Center was doing is unusual. In a summary of the case just published in the Nonprofit Quarterly, Rick Cohen wrote,

As studies from the General Accounting Office and the Congressional Research Service show, these nonprofit indulgences are frequently standard operating practice. The hospital has dismissed all criticisms by pointing out that UT Southwestern’s fundraising and expenditure patterns are right in line with nonprofit hospital practices nationally, including the proportion and nature of expenditures on fundraising including gifts for donors. They further suggest that donors to the UT Southwestern foundation fundraising arm know full well that their donations—classified as unrestricted—will be used for expenses that aren’t particularly focused on medical care or research, but for the CEO’s club memberships, upscale dinners and gifts for donors and bigwigs, and flower arrangements sent to the CEO’s home. Therein may be the real issue, not that UT Southwestern is behaving out of the norm, but that it is exactly within the mainstream of big nonprofit hospitals. And no one seems all that put out, because this is what is expected of big corporate institutions, for-profit, nonprofit, hospitals, universities, corporations, it really doesn’t matter all that much.

So it would surprise me not at all to find out that many executives of many academic medical centers and teaching hospitals are similarly living the high life. This, of course, goes along with many discussions on Health Care Renewal of health care leaders who seem to put their pocketbooks ahead of their patients. If this is as widespread as Rick Cohen and I think it is, why are we wondering why health care is increasingly expensive and inaccessible, while its quality declines, and health care professionals get ever more disgruntled?

Friday, March 14, 2008

Hacking an ICD - A Dual Medical Informatics/Ham Radio Perspective

Roy Poses wrote at "Hacking an ICD" that:

An ICD is a device whose correct operation is critical for the health and safety of patients in whom it is implanted. One would think that the managers responsible for the design of such devices would have pushed to make sure that the operation of such devices could not be hacked or accidentally altered in ways that could put patients' health and lives at risk.


It is probably not well known that in addition to being a Medical Informaticist, I am also a ham radio enthusiast, licensed at the Extra class. I know more about electronics than most physicians - and most IT people in hospitals to boot, although that often didn't matter in the dysfunctional world of hospitals and health IT.

As a medical informaticist and ham radio operator, I am concerned by the possibility of long(er) range hacking of implantable medical devices than that accomplished by researchers recently.

Apparently ICD's use a frequency of about 175 kHz for data communications. 175 kHz is in a band known as longwave. For comparison and orientation, the bottom of the familiar medium wave band -- a.k.a. ordinary AM radio-- is 520 kHz.

(An aside for those interested: shortwave starts at about 1,800 kHz or 1.8 MHz and extends to about 30,000 kHz or 30 MHz, and is called "shortwave" for historical reasons; the actual wavelengths are appx. 160 meters to 10 meters. These wavelengths were considered "short", comparatively speaking, in the early days of radio. The shortwaves have the property, under proper conditions, of being refracted back to earth by the earth's ionosphere and can be reflected by the earth itself. This allows the waves to do "multiple hops" and propagate over great distances far in excess of line-of-sight, even around the world. Hence the ability of ham radio enthusiasts to talk to people all over the world on the shortwave bands allocated to them.)

When I was 13 years old I built a one-transistor transmitter on a cigar box from a plan by Heathkit that transmitted low power morse code at a frequency of about 550 kHz. It ran off a few AA batteries and used a short wire as an antenna. It was easily receivable on a radio across the house.

The first cordless phones ca. early 1980s, wireless baby monitors, and other devices operated at about 1,700 kHz, just above the AM radio band. They were very low power devices with short antennas relative to wavelength (~175 meters) but were usable at dozens of feet from their base units.

Using an antenna, say, the size of a CB whip (properly loaded electrically to resonate at 175 kHz, not very efficient but usable), or even better, a directional loop antenna, plus a transmitter of 5 or 10 or, perhaps, 100 watts of power (not very hard to build), and using a sensitive receiver designed for those frequencies (my $150 retail Grundig Yacht Boy is an example, with modifications and a suitable low-noise receiving antenna, would potentially extend the range of communications with RF-controlled implantable devices.

Not to miles with any type of portable equipment, I should add, due to efficiency issues with very short antennas (relative to wavelength) and the low power of the ICD's transmitter, but tens of feet might be possible. Throw in digital signal processing on the hacker's receiver, which is available via common, cheap, off-the-shelf DSP chips and algorithms, and even more range would be likely. You would be surprised at what a DSP-equipped and/or computer-enhanced receiver can pull out of the "ether" even under extremely poor signal conditions.

One wonders if any ICD's transmitter and receiver are encrypted in any way - apparently the devices tested were not. My car FOB is, although even those can be hacked (e.g., "Prius Security System Cracked",

A talk given at the computer security conference, CRYPTO 2007, explained how the key-fob system installed on the Toyota Prius has been cracked. The KeeLoq auto anti-theft cipher is used in common devices made by Microchip Technology Inc, which are also used by Chrysler, Daewoo, Fiat, General Motors, Honda, Volvo, Volkswagen, and Jaguar. The attack requires that the thief gets within range of your RFID keyfob, in order to break the encryption. This could mean stealing your keys, or just sitting next to you in a cafe with a laptop. The cipher used in these devices is 64 bit, which has always been theoretically possible to break, but has now been shown to be breakable in about an hour. This is important, because the shorter the amount of time required with the key, the more likely this attack is to become used outside of a research lab.

May I add that while encryption is not foolproof, lack of encryption seems the work of fools.

On a somewhat unrelated note, you can buy a wrist watch that picks up time-setting signals from an atomic clock via station WWVB, Fort Collins, Colorado ( at long wave frequency 60 Khz for $30. I have one and in Philadelphia, it works well.

Some hams bounce signals off the moon for earth-moon-earth communications. They use high power, high gain antennas, and very low noise receivers. It works quite well.

Never underestimate what can be done at RF.

On one (predictable) industry response:

Medtronic's Rob Clark said the company's devices had carried such telemetry for 30 years with no reported problems. 'This is a very low-risk event for patients that have these devices,' Clark said in a telephone interview."

It would have been just a bit harder to hack a computerized device 30 or 20 or even 10 years ago. When kids can buy a laptop with computing power exceeding that of the Cray supercomputer for $500 and crack into, say, the Pentagon's systems, we are indeed living in different times.

Dr. Poses also wrote that:

The most charitable explanation for why they [the manufacturers] did not think to [engineer ICD's to be exceptionally hacker-proof] is that they really did not understand the clinical context in which this device would be used.

I think a better explanation is that the manufacturers' management has little imagination and underestimate the capabilities of people much smarter and more creative than themselves (e.g., tech-savvy kids). It would not surprise me to find engineering memos warning management that more safeguards needed to be incorporated, only to be asked "What's the ROI?"

The bottom line is: manufacturers might need to work a little harder when they deploy wireless devices, as hacking of gadgets and computerized equipment such as cell phones seems to be an increasingly common pastime for today's youth. (It's too bad ham radio is itself losing numbers as the previous generation ages and dies out.) The internet itself is used to spread techniques and malicious code among hackers.

One can imagine the consequences of a malicious RF device hacker or smart-but-delinquent kid in, say, a crowded shopping mall.

Finally, ham radio experimenters worldwide are not unfamiliar with longwave experimentation. Note in particular the bolded statement below:

With no Amateur Radio low-frequency [longwave -ed.] allocation in North America, stations operating under FCC Part 5 Experimental licenses in the US or under special experimental authorizations in Canada nonetheless continue to research the nether regions of the radio spectrum. By and large, LF experimentation is occurring in the vicinity of 136 kHz--typically 135.7 to 137.8 kHz--where amateur allocations already exist elsewhere in the world. The FCC rejected the ARRL's 1998 petition for LF allocations at 135.7 to 137.8 kHz and 160 to 190 kHz, however, after electric utilities objected that ham radio transmissions might interfere with power line carrier (PLC) signals used to control the power grid.

"Most of the new LF activity of Part 5 licensees has been in the shared 137 kHz amateur allocation available in some parts of the world," says low-frequency experimenter Laurence Howell, KL1X/5. "Although not in the Amateur Radio Service, these Part 5 experimental stations continue to add to our knowledge on propagation and engineering."

The holder of Part 5 Experimental license WD2XDW, Howell who's also GM4DMA, previously operated LF from Alaska. He's since relocated to Oklahoma, and has now resumed his LF work on 137.7752 and 137.7756 kHz. Already he's reporting some spectacular success, despite antenna limitations. On October 28, New Zealand LFer Mike McAlevey, ZL4OL, copied WD2XDW's 137 kHz carrier "bursts" over a path of more than 13,000 km (8000 miles).

The take-away message is that:

  • In biomedicine, the most meticulous resilience engineering is never a bad idea.

When drug and device manufacturers understand this fully, perhaps we will no longer have incidents of bad health informatics that can kill.

-- SS