Dr. Stossel Sounds Off

DR. STOSSEL SOUNDS OFF

Thomas Stossel, MD, Professor of Medicine at Harvard Medical School, has released another opinionated piece this week on academics’ conflicts of interest. It appears in this week’s British Medical Journal. Like his previous rants, this one combines tangentiality, circumstantial thinking, illogical thinking, false assumptions, smears, insults, and the demonizing of those with contrary opinions. Roy Poses did an excellent job of exposing Stossel’s rhetorical smoke and mirrors, so I will not belabor this point.

The central pathology in Dr. Stossel’s rant is his denial or minimization of current ethical problems in academic-corporate relationships in medicine. If he wishes to be taken seriously, he should familiarize himself with case studies of the corporate corruption of medicine. Contrary to Stossel’s assertion that these problems don’t exist, here is a link that describes the corruption of a major journal by key opinion leaders in cahoots with Pharma executives: http://hcrenewal.blogspot.com/2008/01/antipsychotic-drugs-for-depression.html . Every sleazy deceit in the book was in play here.

There are similar problems in continuing medical education events that are funded by drug and device corporations. See here: http://hcrenewal.blogspot.com/2008/01/variations-on-theme-of-sleaze.html

The main player in these unsavory instances is a member of the Institute of Medicine of the U.S. National Academy of Sciences. This individual is an ethical recidivist who has been outed multiple times for failure to disclose salient conflicts of interest; who was forced to resign the editorship of a major medical journal; and who was forced to retract false statements that favored his corporate clients (otherwise known as shilling). Dr. Stossel notwithstanding, the rest of us are appalled by such tastelessly venal spectacles at the highest level of American medicine. Is it any wonder that the likes of Dr. Stossel are viewed as challenged?

Quality and the Blogosphere: Worthwhile Journal, Editor, and Editorial

In her "Editor's Notebook" for the first 2008 number of Patient Safety & Quality Healthcare, editor Susan Carr writes convincingly about the impact of blogs on health policy discussions. Title: "The Blogosphere." Example cited: the recent flap over the shuttering of a seemingly quite successful QI program in Michigan by the federal Office for Human Research Protections.

Carr cites HCRenewal friend Robert Wachter (and erstwhile guest columnist right here in this blog when he's not writing his own), who responded convincingly to the OHRP debacle after Atul Gawande blew the whistle in the New York Times. (Wachter: "Did I violate federal regulations today? I hope so.")

She concludes that the Internet is transformative in creating transparency in these matters. Or at least the possibility of letting in some cleansing sunshine. We hope she's right, and we plan to explore such influences more formally in the next couple of years.

You'll hear about it right here in HCRenewal.

The Rower Mis-Impresses? - Pfizer Ends its Lipitor Advertising Campaign

We posted last week about misleading aspects of the Pfizer Inc US television advertising campaign for Lipitor (atorvastatin), some of which were recently discovered by NY Times reporter Stephanie Saul. The ads centered on Dr Robert Jarvik. They touted him as a physician with great expertise about the heart. However, although Dr Jarvik does have an MD, he never was an intern or resident, never got a medical license, and never practiced medicine. Dr Jarvik's career is that of an inventor and biomedical engineer. Furthermore, the ads gave the impression that Dr Jarvik is tremendously fit, showing him jogging and apparently rowing a racing scull. However, a body double, not Dr Jarvik, was rowing the boat.

This week, Pfizer cancelled the advertising campaign. As reported again in the NY Times by Ms Saul, "Under criticism that its ads are misleading, Pfizer said Monday it would cancel a long-running advertising campaign using the artificial heart pioneer Dr. Robert Jarvik as a spokesman for its cholesterol drug Lipitor."

Meanwhile, further information came out suggesting that the campaign was even more misleading than previously thought. The ads originally touted Dr Jarvik as the inventor of the artificial heart. However, this is actually in dispute. Ms Saul also reported that

at least one former colleague of Dr. Jarvik’s ... contends that he was not the actual inventor of the artificial heart, as stated in the ads.

In a letter to Pfizer in August 2006, three former colleagues of Dr. Jarvik’s at the University of Utah complained that the ads erroneously identified Dr. Jarvik as 'inventor of the artificial heart.' That distinction, they said, should go to Dr. Jarvik’s mentor, Dr. Willem J. Kolff, and his associate, Dr. Tetsuzo Akutsu.

Pfizer subsequently changed its ads to identify Dr. Jarvik as the inventor of the 'Jarvik artificial heart,' but Dr. Jarvik’s former colleagues, members of a large team that worked on the heart, were not entirely satisfied, according to Dr. Donald B. Olsen, a veterinarian who worked on the heart and is president of the Utah Artificial Heart Institute.

In addition, the ads present Dr Jarvik as someone who actually takes Lipitor. However, Dr Jarvik really is not a long-term user of Lipitor. A NY Times editorial stated "that Dr. Jarvik only started taking Lipitor about a month after he started touting its virtues under a contract that would pay him a minimum of $1.35 million over two years."

Pfizer's decision to stop the advertisements drew praise from some US Congressmen who are now investigating direct to consumer (DTC) drug advertising. Bart Stupak (D - Michigan) said, "I commend Pfizer for doing the right thing and pulling the Lipitor ads featuring Dr Jarvik. When consumers see and hear a doctor endorsing a medication, they expect the doctor is a credible individual with requisite knowledge of the drug."

I agree that it is good that this particular advertising campaign has stopped. However, it is not clear whether the leadership of Pfizer, or of any pharmaceutical company has learned anything from this case. Here is how Pfizer explained its actions (again, per the NY Times article by Ms Saul),

'The way in which we presented Dr. Jarvik in these ads has, unfortunately, led to mis-impressions and distractions from our primary goal of encouraging patient and physician dialogue on the leading cause of death in the world — cardiovascular disease,' Pfizer’s president of worldwide pharmaceutical operations, Ian Read, said in a statement. 'We regret this. Going forward, we commit to ensuring there is greater clarity in our advertising regarding the presentation of spokespeople.'

First, note that Mr Read's pledge of clarity seems limited only to "the presentation of spokespeople." Second, and more importantly, note that Mr Read, and through him, Pfizer really never admitted any fault, particularly not for fielding an advertising campaign that had multiple misleading elements. Instead, he seemed to spread the blame among television viewers and print media readers, that is, those who developed "mis-impressions and distractions." Note that Mr Read did not even admit that the advertisements were meant to market Lipitor. Instead, he portrayed them as an educational exercise meant to encourage "patient and physician dialogue."

It may be that it is hard for Pfizer leadership to move on from a two-year plus advertising campaign orchestrated by the Kaplan Thaler Group ((a unit of the Publicis Groupe) that cost more than $258 million since the beginning of 2006 (again per the Times article).

In my humble opinion, though, this inability to admit any fallibility on the part of Pfizer leadership underscores a central problem affecting the leadership of many health care organizations. Much current business thinking seems to support the concept of the infallibility and omniscience of "imperial CEOs," presumably partly to justify their pay so enormous it could not be due to mere mortal men and women. The infallible, by definition, do not make mistakes. So many organizations seem unable to admit mistakes, much less worse misconduct, by their leaders. Of course, inability to admit mistakes makes it likely that even worse mistakes will be made in the future.

The NY Times editorial called this case "a telling reminder that consumers, besieged by drug promotion ads on television and in print media, need to take what they see, hear and read with a very large grain of skepticism." It also suggested "drug companies would be wise to find pitchmen who have the credentials - and the athletic skill - to back up their claims, without having to rely on stunt doubles."

I say, as long as drug companies continue to be lead by "imperial CEOs," and hence by people insulated from criticism and immune to self-doubt, their emphasis on marketing ahead of science will continue. Furthermore, as long as drug company marketers are convinced that they are providing education, they will continue to make misleading pitches, no matter who the pitchmen are.

BLOGSCAN - Sanofi-Aventis Teams with Mainstream Media to Promote Anatomy Education

On the PharmaGossip blog, there have been several recent posts about who now gets to be a pharmaceutical representative. This post is about a representative for an unnamed pharmaceutical company who is now appearing on the Big Brother television show. Her bio for the show features this self-description, "confident, agile and sexy." Two posts (here and here) are about "Playboy model" Cameron Haven, alleged to be a representative for Sanofi-Aventis. (Note: the links in these PharmaGossip posts are too explicit to open at work, or in the presence of children.)

Pharmaceutical marketers repeatedly argue that their main goal is physician education, so maybe they could argue that now they have teamed with mainstream media to increase the impact of anatomy education. Perhaps, though, if pharmaceutical companies really want to regain the reputation they once had, they ought to rethink sending Playboy models to "educate" physicians.

BLOGSCAN - Dubious Clinical "Researchers"

On the Clinical Psychology and Psychiatry Blog, two posts (here and here) gave examples of how the physicians pharmaceutical and biotechnology companies hire to implement their clinical trials may not always be qualified or competent to do such work, to put it politely. Despite some egregious conduct by such "researchers," the US Food and Drug Administration (FDA) has been slow to take action against them, and presumably the data they produce may still be used to argue for the advantages or particular drugs.

In pharma, is Medical Informatics a field any technology geek can do?

As readers here know, I’ve written on the blur and confusion regarding the formal specialty of Medical Informatics in the pharma industry e.g., "Why Pharma Fails", "CRO's: We don't need medical informatics here", "We don't need medical informatics here Part 2" and "GSK, Avandia and Medical Informatics: More on Why Pharma Fails." I am also reminded how this problem, complicated by the conflation of IT and information science, cause the industry to suffer at both ends of the pipeline, that is, new drug discovery as well as postmarketing surveillance.

Seen recently in a Pfizer job ad for a Senior Manager, Medical Informatics:

The role of Medical Informatics team is to bring a deep understanding of technology in order to address Medical business needs. The successful candidate will be able to leverage technology insights and experience in order to provide solutions that balance opportunities for innovative ideas that drive top-line growth with a focus on operation efficiencies that drive bottom-line efficiencies/savings.

Ironically, one major research area of Medical Informatics is in terminology development, to help ensure expressive clarity.

I am only going to ask two questions this about that paragraph:

What the heck are they talking about?

and

Did the writer ever pass a course in basic English composition?

Here are the position requirements:

• 5-8 years experience in technology related field.


• Excellent verbal and written communication skills


• Proven ability to deliver technology strategy and innovations that support business growth while still assuring operational excellence in support of existing systems and business processes


• An operating style that is flexible, professional, and driven by individual initiative

Notably missing: biomedical background, professional degree, medical informatics professional training, and any knowledge of information technology in clinical or medical research settings.

Worse, it's likely the person(s) who wrote/approved the above tortured paragraph (a generously mild description) will also be evaluating the incoming applications.

In pharma, Medical Informatics seems to be an area any ol' technology geek (perhaps even semi-literate ones) can not just perform, but can also oversee as Senior Manager.

-- SS

The Judge Cites Health Net's "Egregious" and "Reprehensible" Business Practices

More than two years ago, we noted that Health Net Inc,, the large US health insurer/ for-profit managed care organization, had settled a class-action lawsuit brought by California physicians under the RICO (Racketeer Influenced and Corrupt Organizations) standard. Late last year, we noted that HealthNet was fined by the state of California for offering bonuses to employees who retroactively cancelled the most individual health policies after their holders got sick and filed claims, and that the company was under investigation in Connecticut for allegedly sending deceptive messages to pharmacists that denied payment for some low-income childrens' medication.

Last week, Florida Health News reported,

Medicare officials have ordered Health Net, Inc., one of the largest publicly traded health insurers in the nation, to stop marketing its “Health Net Orange” prescription drug plans.

The U. S. Centers for Medicare and Medicaid Services also froze enrollment in the drug plans, according to an obscure notice on a government Web site.

The government acted against the California company because it fell behind in processing enrollment applications and sent members incorrect information about changes in their coverage for 2008, said CMS spokeswoman Allison Henry.

Also last week, Lisa Girion wrote in the Los Angeles Times, that Health Net was being sued by the Los Angeles City Attorney for allegedly retroactively canceling individual insurance policies after their holders got sick, and was opening a criminal investigation of allegations that the company paid bonuses to employees who cancelled the largest number of policies.

To top it all off, Lisa Girion also reported in the Los Angeles Times,

One of California's largest for-profit insurers stopped a controversial practice of canceling sick policyholders Friday after a judge ordered Health Net Inc. to pay more than $9 million to a breast cancer patient it dropped in the middle of chemotherapy.

The ruling by a private arbitration judge was the first of its kind and the most powerful rebuke to the state's major insurers whose cancellation practices are under fire from the courts, state regulators and elected officials.

Calling Woodland Hills-based Health Net's actions 'egregious,' Judge Sam Cianchetti, a retired Los Angeles County Superior Court judge, ruled that the company broke state laws and acted in bad faith.

'Health Net was primarily concerned with and considered its own financial interests and gave little, if any, consideration and concern for the interests of the insured,' Cianchetti wrote in a 21-page ruling.

When Health Net dropped her in January 2004, Bates was stuck with more than $129,000 in medical bills and was forced to stop chemotherapy for several months until she found a charity to pay for it.

Amazingly enough, Health Net's top leader actually promised to stop retroactive cancellations of individual policies, and expressed what appeared to be remorse for his company's actions.

Health Net Chief Executive Jay Gellert ordered an immediate halt to cancellations and told The Times that the company would be changing its coverage applications and retraining its sales force.

'I felt bad about what happened to her,' he said. 'I feel bad about the whole situation.'

Gellert said he would move quickly to 'give people the confidence that they can count on their policy.' Specifically, he pledged to stop all cancellations until an external review process could be established to approve all cancellations.

Until Friday, the companies had uniformly defended cancellations, saying they were necessary to hold down costs by weeding out people who may have failed to disclose pre-existing conditions on applications for coverage. They say cancellations happen infrequently.

It is also noteworthy that documents produced during the trial appeard to confirm previous allegations that Health Net paid bonuses to employees who retroactively terminated the most individual policies.

At the arbitration hearing, internal company documents were disclosed showing that Health Net had paid employee bonuses for meeting a cancellation quota and for the amount of money saved.

'It's difficult to imagine a policy more reprehensible than tying bonuses to encourage the rescission of health insurance that keeps the public well and alive,' the judge wrote.

HealthNet has now quite a record of bad behavior, from settling a racketeering-influenced corrupt organization (RICO) lawsuit, being fined for paying bonuses to employees for retroactively canceling individual health policies, being forbidden to market specific policies by the US Center for Medicare and Medicaid Services (CMS) because the company provided policy-holders misleading information, to now being subject to punitive damages for a single, "egregious" retroactive policy cancellation. That's quite a track record. Yet despite this record, so far no individual company leader has had to pay any penalty, and while the company is lead by the same people who were apparently responsible for all these previous messes, the company's business has not suffered.

This illustrates a huge problem with the current way health care operates in the US. There are no major disincentives of any kind for leadership that puts the company's and their "own financial interests" ahead of patients' interests. The leaders do not have to fear for their jobs, reputations, or pocketbooks. After all was said and done, at the most they might have to say "sorry."

Until our system and culture start to provide for major disincentives for unethical business practices by leaders of health care companies, such practices will continue unabated. The results will continue to be "egregious" and "reprehensible."

One wonders with all the hand-wringing about health care going on during the current US presidential campaign, whether anyone will notice that mismanagement and unethical business practices in health care organizations likely account for much of our excess costs, poor access, and degrading quality. Revamping health care financing might change the nature of the mismanagement and unethical business practices that afflict health care, but it won't eliminate them. We will have more cases like that of HealthNet, worse cases than that of HealthNet as long as we ignore these elephants in health care's living room.

ADDENDUM (29 February, 2008) - See also comments on the Effect Measure blog, and The Health Care Blog.

EMR Recipe for Disaster: Leadership by Delusional Bureacrat, the NHS example

My webcast on an "irrational exuberance" over clinical IT (electronic medical records and associated applications) was recently posted to the website "Government Health IT" (of the U.S. government, that is). I have also had an educational web site online for almost a decade on the topic of health IT difficulties entitled "Sociotechnologic Issues in Clinical Computing: Common Examples of Healthcare IT Difficulties".

Over the years I have noticed many hits from the domain "nhs.gov" (UK National Health Service). Why is that relevant? Read on.

My web site points out the myriad false assumptions, underestimations, misplaced beliefs in technologic determinism, and the major differences between business computing -- descended from the IBM punch card and plug-panel tabulating machines widely used to manage manufacturing and mercantile businesses decades before the electronic computer -- and clinical computing, descended from the creative work of medical computing pioneers using stored-program computers as a "canvas" to paint works of art.

(An aside: ever wonder why the so-called first "modern computer", the ENIAC, was programmed with patch cords? Think of the people who were acculturated via such machines, who set the tone for today's management information systems profession, and compare to the culture of clinicians. Meanwhile, foreign nationals with much better ideas on computation have largely been written out of the computing history books for some reason.)

My health IT website also illustrates how these false assumptions and underestimations, and leadership by bureacrats lacking clinical and biomedical backgrounds (and oftentimes, it seems, basic competence), result in problems ranging from major difficulties to catastrophic HIT project failures.

Now, here is a poster example of what I call "irrational exuberance" over health IT, at the highest levels of government. My comments in red:

ComputerWeekly.com

Blair Rushed NHS IT
Posted: 13:00 18 Feb 2008

Tony Blair repeatedly sought to shorten the timetable for the NHS IT programme in a move that would have brought results for patients in time for a general election in 2005, Computer Weekly has learned. Papers obtained under the Freedom of Information Act show that the Department of Health drastically underestimated the time it would take to make electronic patient records available online. [Did I see the word "underestimate?" - ed.]

In papers presented to an NHS IT meeting at Downing Street , the Department of Health promised systems would provide "seamless" care across the NHS by 2004/05 - less than half of the time now allotted to the scheme. The meeting, on 18 February 2002, was attended by IT suppliers, policy advisers and health experts.

But Tony Blair made it clear that he regarded even the 2004/05 timescale as too long. He asked repeatedly for it to be shortened, which would have brought visible benefits in time for a general election in May 2005.

Blair told the meeting that implementing the programme faster than planned would underpin the government's reform agenda and provide evidence of NHS modernisation to the public.

But the timetable in the Department of Health papers has proved hopelessly optimistic. Access by patients and doctors to national summary care records are only at a trial stage. And contracts for the delivery and implementation of new national systems run until 2013 - eight years later than the timetable presented to Downing Street [after many billions of British pounds have likely been thrown down to loo due to the rush - ed.]

The Department of Health awarded a series of contracts in record time under the NHS's National Programme for IT (NPfIT) in 2003, but some suppliers complained they were being given too little time to consider their proposals.

The main part of the programme - a national electronic health record - is running three years behind the original timetable, in part because the idea is more difficult than first thought to put into practice. [Oh - wait - you mean, automating medicine is harder than automating the production of widgets? - ed.]

The papers raise questions about whether the timetable for the NPfIT was geared towards a general election, rather than the practicalities and complexities of the scheme - and whether the Department of Health put politics before realities in promising the programme in less than three years. [Need I answer that? - ed.]

Paul Cundy, GP IT spokesman for the British Medical Association, said it appeared that the Department of Health had been "wildly, even delusionally, optimistic about the timetable for the NPfIT in order to secure funding". [Might I add "irrationally exuberant" and "suffering from the syndrome of inappropriate overconfidence in computers"? - ed.]

Vince Cable, deputy leader of the Liberal Democrats, said the Downing Street papers showed that the NPfIT was launched after a discussion that stood out for its "amateurism, naivety and a lack of consideration of the practicalities". [Indeed - ed.]

Health IT can accomplish its many stated goals, but only if done correctly. If not, it will be an annoyance at best, and a hazard as a tool for payer and governmental abuse of clinicians and patients at worst.

There must come a time when medicine's professionals stand up for their profession and stop permitting politicians, business interlopers and other parasites from attaching themselves to medicine's back and sucking the blood and sweat of its practitioners, and siphoning off capital better used to improve health.

Recklessly tranferring massive amounts of money from the healthcare sector to the IT sector, so that politicians can get re-elected, clinicians can be the development lab and beta testers for inept software companies, and so that information technology personnel who faint at the sight of blood can have nice jobs in hospitals and healthcare organizations, is not the way to accomplish this mission.

Unfortunately, those in the know (the healthcare informatics community) either are too timid to speak out politically about the abuses in the health IT industry, too conflicted financially, or too academically orientated to make any difference (i.e., after major system disasters are described by the principals, the evidence is written off as "not scientifically grounded.") Lastly, those who do try to report on such problems receive much pushback and/or become marginalized.

Scott Adams once observed a number of categories of irrational thinking. One of them was this:

IGNORING ALL ANECDOTAL EVIDENCE
Example: I always get hives immediately after eating strawberries. But without a scientifically controlled experiment, it's not reliable data. So I continue to eat strawberries every day, since I can't tell if they cause hives.

The UK NHS IT experience is one big, stunningly red strawberry. Will the medical and healthcare informatics communities learn anything from it?

I have my doubts.

Finally, who at nhs.gov has been reading my website over the years? Did they understand it? Did they try to use it and related writings by others in pushback against artificially rushed schedules? Or were such writings dismissed as the rantings of luddites?

Inquiring minds would like to know.

-- SS

Heparin Made Out of Pigs from Elsewhere

Last week, we discussed what was known about the sudden increase in the frequency and severity of adverse effects due to heparin, an anti-clotting drug that has been in use for more than 7o years. The heparin all carried the Baxter International label, but its "active ingredient," that is, the heparin itself, was purchased from 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. Furthermore, it turns out that the factory was never inspected by either the US Food and Drug Administration (FDA) or its Chinese counterpart.

First, the Wall Street Journal reported how heparin is made in China.

In a small, damp factory here [in Yuanlou, China], blood-smeared men wring pulp from pig intestines, then heat it in concrete vats.

The activity at Yuan Intestine & Casing Factory is the first step in the poorly regulated process of making raw heparin, the main ingredient in a type of blood-thinning medicine that in recent days has come under suspicion in the deaths of four Americans.

More than half the world's heparin comes from China. The chemical is often extracted from pig entrails in small factories -- many as rudimentary as this one, which also manufactures sausage casings from intestines.

Heparin goes through extensive processing in its journey from abattoir to IV bag. Nevertheless, because some of it originates in tiny Chinese factories like these, if there's a problem with the final medication, it can be nearly impossible to trace the raw heparin back to the source, the pigs whose tissue was used to make it.

Heparin makers in China readily acknowledge the lack of oversight. Yuan Changkun, the owner of the small factory here, says health regulators don't visit his plant. Mr. Yuan doesn't keep records of where he acquires the intestines he uses. Nor is he sure who the end customers are.

The raw heparin made by China's myriad small producers ends up in the hands of about 50 export companies, which sell to customers overseas. In the first half of last year, more than 85% of these heparin exports went to the U.S., Austria, France, Italy and Germany, according to an industry trade group.

In fact, although Scientific Protein Laboratory did not get the heparin it sold to Baxter International from Yuan Changkun, it appears that the management of SPL did not know much about the heparin it supplied.

David Strunce, the president of Scientific Protein Laboratories, Baxter's main supplier of heparin, says that the Yuan Intestine & Casing Factory isn't in his company's supply chain. He says Scientific Protein can't trace its supplies in China in as much detail as it can in the U.S. 'We're all dealing with the China collection system,' Mr. Strunce says.

In fact, Changzhou SPL actually was not the source of the heparin that eventually got the Baxter International label. Changzhou SPL, in turn, got the heparin from a number of wholesalers who in turn, got it from a number of smaller, unnamed factories.

Scientific Protein's Mr. Strunce says his company's China venture, Changzhou SPL, gets raw heparin from two wholesalers who gather it from 'six to 12' workshops. 'You can have better, or less good, workshops, Mr. Strunce says.

So to recap so far, Baxter International got the heparin that it sold under its label from SPL, which got the heparin from Changzhou SPL in China, which got the heparin from several wholesalers, which got the heparin from numerous, unnamed small factories. Apparently at none of the steps along the way in China was the heparin subject to any inspection or regulation by the US FDA or its Chinese counterpart.

Then, the Chicago Tribune reported,

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.

Parkinson noted that Baxter's auditors had inspected the facility in the last six months, but he declined to speculate on whether they may have missed something.

'It is both premature and inappropriate to go down that path,' he said.

So, to summarize, a commonly used drug which carried the label of a formerly respected US pharmaceutical company actually came down a torturous supply chain that began in several small factories in China. The factories, and the entirety of the supply chain was never subject to FDA inspection. The respected US company and its CEO did not seem aware of who was actually making the drug it sold under its name, and under what circumstances it was made. The US company that was the proximate source of the active drug to the pharmaceutical company, and its CEO did not seem aware of who was actually making the drug it supplied, and under what circumstances it was made.

Most US corporate CEOs receive extremely generous compensation. For example, Robert L Parkinson, the CEO of Baxter International, was recently reported as getting $3.16 million a year in total compensation. One common explanation for such compensation that to some borders on the outrageous is that the CEOs have to make the tough decisions and take ultimate responsibility for what their companies do. Yet Mr Parker did not seem aware of company practices critical to the health and safety of the patients who were using Baxter International products.

More importantly, patients and physicians used to have some reason to trust the quality of drugs made by US pharmaceutical companies. But now, big US pharmaceutical companies seem willing to outsource the drugs that doctors and patients thought the companies themselves made. Big US pharmaceutical companies do not always seem to know where and how these drugs are made.

In addition, patients and physicians used to have some reason to trust that the FDA was assuring the quality and purity of drugs. My dim recollection of the history is that the FDA was founded to assure the purity and quality of US pharmaceuticals. But now, the FDA no longer seems to be keeping track of an increasing proportion of drugs marketed by US companies, but actually made somewhere else.

So tell me again why US patients and physicians should trust these companies to provide them with pure drugs which are as safe as their labels purport them to be, and why they should accept the high prices these companies charge for their heavily marketed products.

Reckless outsourcing of drug production, failure of US pharmaceutical companies to control and be responsible for how and where the drugs they market were made, and the FDA's failure to monitor drugs sold with US company labels but made somewhere else threaten a crisis of confidence that could have dire consequences for US health care.

ADDENDUM (22 February, 2008) - Also see comments on Effect Measure blog.

Times Flogs Blog Clog

An article in today's New York Times (February 20, 2008) exposes the curious matter of a San Francisco federal judge attempting to stifle whistleblower bloggers.

As the result from--get this--a suit from the Cayman Islands, that bastion of transparency and probity, Judge Jeffrey S. White shut down--no let's put that in inverted commas, "shut down," the www.wikileaks.org Website.

Judge White did this by forcing the organization's Internet domain name registrar to put the kibosh on users' access to "www-dot-wikileaks-dot-org."

We ask: what was he thinking? Exactly what purpose is served by the erection of one-millimeter speed-bumps?

Actually shutting down Internet access to free speech, as you saw if you just clicked on the above URL, and as authorities discover daily in certain countries that don't believe in it, turns out to be not quite so easy. The IP address still works, as you just saw. What's more, putting "wikileaks.org mirror" in a search engine quickly gives access to the meshwork of sites that ardently defend this group's mission.

We make no pretense of having performed extensive research on the net "goodness" of the organization behind wikileaks. But, as the Times points out, "forbidding the dissemination of ... documents, is a more classic prior restraint on publication. Such orders are disfavored under the First Amendment and almost never survive appellate scrutiny."

"In the Middle of All Those Pigs in China" - the Case of the Allergenic Heparin

The case of the allergenic heparin seems to be opening up a new window on how US pharmaceutical industry is managed, or mismanaged.

The story started with reports of unusual numbers of allergic reaction, many serious, to parenteral heparin, a drug in use for over 70 years to reduce blood clotting. Most of the afflicted patients were dialysis patients who get large doses (boluses) of heparin to prevent blood clots during dialysis. The reactions included "nausea, difficulty breathing and rapidly falling blood pressure that can lead to death." The reactions affected patients receiving heparin from multi-use vials made by Baxter International. "About 350 events linked to Baxter's heparin have been reported since the end of last year compared with less than 100 reports in 2007." Baxter recalled lots of heparin which "all came from a Baxter facility in Cherry Hill, N.J."(1)

But then the plot started to thicken. Last week we found out:

• Baxter Actually Didn't Make the Heparin. A Chinese Factory Made It, then Shipped It to a US Company, Which Shipped It to Baxter. "A Baxter spokeswoman confirmed that the company gets the active pharmaceutical ingredient for its heparin from a U.S. supplier that operates a plant in China and another in the U.S., but she declined to identify the supplier." (2)
• The FDA Never Inspected the Factory Which Made the Heparin. "The FDA said last night that it hadn't inspected the Chinese facility that made the active ingredient in the Baxter drug." (2)
• The FDA Admitted It Should Have Inspected the Factory. "The FDA spokeswoman said the plant making the active ingredient 'was supposed to be inspected' but 'our understanding is that, due to human error, and inadequate information technology systems, a pre-approval inspection, which would normally be conducted, was not.'"
• Responsibility for the Manufacture of the Heparin was Dispersed Among Multiple Entities in Two Countries. "Baxter said the active ingredient for its heparin was supplied by Scientific Protein Laboratories LLC, a Waunakee, Wis., company with a manufacturing facility there and a joint-venture operation called Changzhou SPL in Changzhou...." Note that "Changzhou SPL ... [is] also known by its Chinese name, Kaipu Biochemical Co...." Furthermore, "Scientific Protein ... is majority-owned by the Bethesda, Md., buyout firm American Capital Strategies Ltd...." In addition, "the Chinese operation ... is also owned by Changzhou Techpool Pharmaceutical Co., of China."(3)
• Failure of the FDA to Inspect the Chinese Factory Violated the Agency's Own Policies. "The Food and Drug Administration violated its own policies when it approved for sale a crucial blood-thinning drug without first inspecting a Chinese plant which, along with a plant in Wisconsin, made the drug’s active pharmaceutical ingredient."(4)
• The Factory that Made the Heparin Was Not Certified to Produce Pharmaceuticals, and Was Never Inspected by Chinese Regulators Either. "A Chinese factory that supplies much of the active ingredient for a brand of a blood thinner that has been linked to four deaths in the United States is not certified by China’s drug regulators to make pharmaceutical products, according to records and interviews. Because the plant, Changzhou SPL, has no drug certification, China’s drug agency did not inspect it." So, "a spokesman for China’s State Food and Drug Administration, Shen Chen, said Friday that 'as far as we know, it is not a drug manufacturer — it is a producer of chemical ingredients.'" (5)
• Production of Heparin was Relocated So It Could Be "in the Middle of All Those Pigs in China." "SPL moved production to China three years ago, he [David strunce, chief executive of Scientific Protein Laboratoris] said, because the Chinese are the world's dominant supplier of hogs."(6)

OK, to summarize, the heparin that Baxter ships with its logo on it was made by a Chinese chemical factory not licensed to produce pharmaceuticals. The rationale for using a Chinese plant was its proximity to pigs. The factory was never inspected by Chinese or US drug regulators. The Chinese factory shipped the heparin to a US company, which shipped it to Baxter. And now heparin made in this way has been associated with hundreds of allergic reaction, many serious, including 4 fatalities.

This case also made it clear how suspect is the provenance of many drugs sold in the US (and around the world) by formerly respectable pharmaceutical companies. "China is now the world's largest producer of active pharmaceutical ingredients.... In 2005, China had $4.4 billion, or 14% of the world's $31 billion market for active drug ingredients...."(2) But, "the FDA may only inspect around 7% of foreign drug-making facilities in a given year...."(2) "A legal requirement for drug manufacturers to get inspected every two years applies only to domestic plants, not the growing list of overseas facilities."(3) The FDA "inspected foreign drug plants at best once every 13 years. The agency's record in China ... is even worse. Of the 700 approved Chinese drug plants, the agency has been able to inspect only 10 to 20 each year...." (4) It is not clear whether the FDA or its Chinese counterpart has ever inspected a Chinese chemical factory that produced pharmaceuticals without a license. Yet, "an unlicensed chemical plant in China made a tainted drug ingredient that poisoned more than 170 people in Panama, killing at least 115."(5) Furthermore, "the Chinese government does not inspect production plants that make drugs solely for export to the U.S. and other markets."(6) So, "'it's a little bit like the wild, wild west as this relationship with the Chinese continues to grow,' said Kip Kirkpatrick, partner with Chicago-based private-equity firm Water Street Healthcare Partners, which has investments in China's drug and medical-product market."(6)

So this tragic case raises many questions for the leaders of the various organizations involved. Why did Baxter farm out the actual production of a drug which it sold as its own? How hard did Baxter scrutinize the production of the drug? How hard tid SPL scrutinize its production? Did Baxter, SPL and/or the FDA realize the drug was being produced in an unlicensed Chinese chemical factory which had never been inspected by the Chinese or US government? If they did, why did they accept its product? If they didn't, why didn't they know? I presume others will be trying to find out the answers to these questions.

Most US drug companies (as well as many other US health care organizations, for-profit and not-for-profit) now are run by businesspeople, not physicians or scientists. Such businesspeople seem to too often worship at the altar of management gurus. Such gurus seem to preach the need to cut costs by out-sourcing and off-shoring, often without too much concern about how well some factory or country in an exotic location will produce the desired product or service. Obviously, such concerns should be heightened because the attractively low prices of out-sourced products and services could be due to poorly paid and unmotivated, if not exploited workers, and shoddy operations using poor quality equipment and supplies. The leaders of health care organizations ought to be particularly worried that cutting costs by out-sourcing may affect the quality of their products and services, and hence may endanger patients' health and safety. The case of the dangerous heparin suggests that these leaders have not been worried enough. One would think that the health of the patients who ultimately would have heparin injected into them ought to outweigh the proximity of a factory to pigs.

If we don't get people who run health care organizations to put patients before profits, there are going to be more dead and injured patients.

References

1. Jepsen B. Baxter halts heparin production after reports of allergic reaction. Chicago Tribune, Feb 11, 2008 (link)
2. Mathews AW, Burton TM. China plant played role in drug tied to 4 deaths. Wall Street Journal, Feb 14, 2008. (link)
3. Burton TM, Mathews AW, Zamiska N, Fairclough G. Heparin probe finds U.S. tie to Chinese plant. Wall Street Journal, Feb 15, 2008. (link)
4. Harris G, Bogdanish W. F.D.A broke its rules by not inspecting Chinese plant with problem drug. New York Times, February 15, 2008. (link)
5. Bogdanich W, Hooker J. China didn't check drug supplier, files show. New York Times, Feb 16, 2008. (link)
6. Greising D, Japsen B. China doesn't check plants that make U.S. drugs. Chicago Tribune, Feb 16, 2008. (link)

BLOGSCAN - Policy Suggestions Re Physicians and Pharma from "Jack Friday"

On the PharmaGossip blog, "Jack Friday" posted his list of suggestions to the UK Royal College of Physicians working group on relationships among physicians and the pharmaceutical industry. He suggested the RCP investigate conflicts of interest affecting UK academic medicine; develop a policies that allow UK clinical researchers access to the data they produce (something which Dr Aubrey Blumsohn was denied); consider how to defend physicians from abuse, but with the realization that physicians who take pharma money perhaps should not complain when pharma asks them to toe the line; and concluded with re-emphasizing the need to investigate financial relationships among physicians and pharma. Good work, "Jack!"

BLOGSCAN - Brody on Institutional Conflicts of Interest

On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody offered some interesting thoughts about institutional conflicts of interest, a topic recently in the news because of a JAMA article that showed few medical schools seem to have clear policies about such conflicts. Dr Brody noted the tremendous pressure on medical schools to bring in external funds, which certainly make it hard for the schools' leadership to deal with ICOIs. (On the other hand, I again wonder why medical schools and academic medical centers are always under pressure to bring in external funds, while the rest of the university seems to mainly get by on tuition, alumni contributions, and endowment income?) Thus, he wonders if any attempt to control ICOIs would work unless some body external to the schools could do the enforcement.

"A Catastrophic Failure" - More on the Ketek Trial Debacle

We previously posted (also here, here and here) about the ill-fated clinical trial, study 3014, of the antibiotic telithromycin (Ketek) made by Sanofi-Aventis, run by Pharmaceutical Product Development Inc. (PPD). Problems with the trial included fabrication of data at one clinical site, and allegations of manipulation of data at another. The physician in charge of the first site was convicted of mail fraud, and the physician in charge of the second had his license suspended. Although the results of this trial were never published, it still crept into the clinical literature: it was cited in a review article in the New England Journal of Medicine.

The case is now the subject of a US congressional investigation. As reported by the Associated Press (via the International Herald Tribune),

Democrats in the U.S. House of Representatives are threatening to hold a member of President George W. Bush's Cabinet in contempt for not turning over documents in a probe of a Sanofi-Aventis antibiotic.

Dingell, who chairs the House Energy and Commerce Committee, said he would support holding Health and Human Services Secretary Michael Leavitt in contempt for refusing to turn over FDA briefing documents subpoenaed by the committee.

The documents were used to prepare FDA Commissioner Andrew von Eschenbach for his appearance before lawmakers last year. Von Eschenbach testified the FDA did not use the flawed safety study to approve Ketek. Dingell and other Democrats say that statement may be untrue.

Robert West, an FDA agent who first investigated Ketek, said he tried to get permission in 2002 to look into whether Aventis was aware of fraudulent data when it submitted the study. West said his request was blocked by senior FDA officials, although he said he did not know which ones.

"A catastrophic failure" was how another FDA investigator, Douglas Loveland, described the company's handling of the study.

"The decision-making process Aventis used to investigate these problems was illogical and ineffective and it could have led them to come to the wrong conclusion," Loveland told House lawmakers.

The investigator stopped short of saying Aventis, Sanofi-Aventis' corporate predecessor, knew the results were false when they submitted them but said it "should have known." Loveland said the results contained all the hallmarks of sham data, including forged signatures and crossed out information.

Sanofi President for Research and Development Paul Chew testified that the company submitted the study in "good faith."

The company was not able to spot the fake patient results....

It seems clear that this case involved a very sloppy clinical trial sponsored and run by a pharmaceutical company. Such sloppy science breaks promises made to human subjects of clinical research that their participation would go to advance science and improve health care. Sloppy trials that produce dubious data will do neither. Furthermore, sloppy science that produces dubious results provides patients and doctors pseudoevidence rather than the best possible evidence relevant to decisions about health care interventions, and hence may also lead to bad decisions that harm patients.

It is bad enough that clinical trials sponsored by pharmaceutical, biotechnology, and device companies are often sloppy, and designed to show their products in the most favorable light, rather than provide valid and unbiased data testing hypotheses most important for patients' and physicians' decisions. This case now raises the more disturbing possibility that high government officials entrusted with protecting the public's health and safety may have hid the sloppiness and unreliability of the Ketek trial. Time and further investigation will tell if this possibility is more than speculation. But the latest events in the Ketek saga clearly show the need for more open and transparent clinical research on drugs and devices, and more open and transparent regulation of such companies by the government.

Blue Cross of California - Wellpoint to Use EMR's to Deny Women Prenatal Care and Encourage Abortions, it follows...

I commented on the "irrational exuberance" over healthcare IT here. Health IT is a double-edged sword. It can be used, and it can be misused. In the hands of the wrong people, it will "revolutionize healthcare" all right ... but not in the direction health informaticists and clinicians would desire.

The title of this post seems the logical outcome based on the self-initiated debacle of Blue Cross of California, as posted at Wellpoint Halts Attempts to Have Doctors "Rat Out Patients":

Blue Cross of California is sending physicians copies of health insurance applications filled out by new patients, along with a letter advising them that the company has a right to drop members who fail to disclose 'material medical history,' including 'pre-existing pregnancies.''Any condition not listed on the application that is discovered to be pre-existing should be reported to Blue Cross immediately,' the letters say.

The full extent of the "medical derangement syndrome" represented by this incident calls for elucidation that seems absent in the main stream media.

First, a plan seeking to deny coverage that specifically singles out a "condition" of "pre-existing pregnancy" is heartless beyond hope:

• Is pregnancy now considered by Wellpoint to be merely a "pre-existing condition?"
• What about women who might not have known they were pregnant at the time of application? With the history of Wellpoint's cancellation of policies, how would such situations be adjudicated, and how rapidly considering the clinical time windows involved?
• Why would such patients be subject to cancellation instead of rate adjustments? Who was to make that determination? What was it to be based on?
  

It seems to me that the intent was to deny coverage to pregnant women who did not for whatever reason disclose their pregnancy, thus pushing them towards inadequate prenatal care and/or abortions.

I would like to know the answers to the following:

• Who conceived this policy and the announcement? What committee and executives approved it?
• Did they have any idea of the all too predictable physician reaction? If yes, did they care?
• If they knew the likely reaction and did not care, why are these people in a position of authority in healthcare?
• If they did not know the predictable reaction, what are people so utterly divorced from medical culture and ethics doing in a position of authority in healthcare?
• Who hired these people?

Finally, being denied access to physicians "ratting out" their patients, it's likely Blue Cross of California will resort to using Health Information Technology and Electronic Medical Records data from physicians to provide the same information.

In effect, it seems Blue Cross of California - Wellpoint will use EMR's and other healthcare IT to deny people coverage, including denying women prenatal care and probably pushing them to have abortions.

Is this the "revolution" health informaticists had in mind when we began advancing the field of computing in medicine?

With regard to their statement "As a result, we are discontinuing the dissemination of this letter going forward", the business-speak spin term "going forward" is best translated as:

We got caught doing some seriously bad sh*t, but let's just sanitize it and brush it under the carpet.

Finally, I find it pathetically ironic that this organization expects potentially hostile-to-self-interest honesty out of its subscribers about their medical histories, when as Roy Poses pointed out, their own corporate history includes:

• Settling a RICO (racketeer influenced corrupt organization) law-suit in California over its alleged systematic attempts to withhold payments from physicians (see post here).
• Being fined for cancelling individual insurance policies (again in California) after their holders filed claims (see post here)
• Being found to have mis-handled at least half of its revocations of individual policies (see post here)

Perhaps honesty best begins at home.

-- SS

Wellpoint Halts Attempts to Have Doctors "Rat Out Patients"

We just discussed the sorry state of Merck Inc, whose founder once said, "Medicine is for people, not for profits," but now seems to be run by people who think otherwise, to the detriment not only of patients, but of the company and most of its employees.

Here is another example of a company that seems to put short-term financial gain ahead of its stated commitment to "improving ... lives."

Lisa Girion, writing in the Los Angeles Times, reported yesterday that Blue Cross of California, a subsidiary of for-profit Wellpoint Inc, has been "asking California physicians to look for conditions it can use to cancel their new patients' medical coverage." In particular,

Blue Cross of California is sending physicians copies of health insurance applications filled out by new patients, along with a letter advising them that the company has a right to drop members who fail to disclose 'material medical history,' including 'pre-existing pregnancies.'

'Any condition not listed on the application that is discovered to be pre-existing should be reported to Blue Cross immediately,' the letters say.

Please keep in mind that insurance companies usually request copies of medical records of people who apply for individual health insurance. However, Blue Cross of California was not simply requesting copies of records. It was asking the physicians to actively look through patients' records for information that could be used to cancel the patients' insurance. It was no wonder that physicians were

'outraged that they are asking doctors to violate the sacred trust of patients to rat them out for medical information that patients would expect their doctors to handle with the utmost secrecy and confidentiality,' said Dr. Richard Frankenstein, president of the California Medical Assn.

Patients 'will stop telling their doctors anything they think might be a problem for their insurance and they don't think matters for their current health situation,' he said.

The California Medical Assn. sent a letter to state regulators Friday urging them to order Blue Cross to stop asking doctors for the patient information, saying it was 'deeply disturbing, unlawful, and interferes with the physician-patient relationship.'

Blue Cross' explanation frankly made no sense: "Enrolling an applicant who did not disclose their true condition (and the condition is chronic or acute), will quickly drive increased utilization of services, which drives up costs for all members,"

Today, Ms Girion reported even more outrage, starting with physicians:

Robert Margolis, a physician and the chief executive of one of the state's largest medical groups, described the letters as "an obnoxious intrusion" on the relationship between physicians and patients.

"Asking us to be the application police is inappropriate," said Margolis, who heads HealthCare Partners Medical Group in Los Angeles.

Some famous politicians got into the act.

[California Governor Arnold] Schwarzenegger sharply criticized the practice, which he described as akin to telling physicians to "rat out the patients and to give the patients' medical history to the insurance company so they have a reason to cancel the policy."

The governor said the practice should be banned.

"That is outrageous," he said, and "one more reason why it is so important to have comprehensive healthcare reform."

Democratic presidential contender [NY Senator Hillary] Clinton said the Blue Cross effort was another "example of how insurance companies spend tens of billions of dollars a year figuring out how to avoid covering people with health insurance."

Somehow, one day after it was revealed that Blue Cross was sending the letters, the company decided to stop, with this burst of business-speak [highlighted in red],

Today we reached out to our provider partners and California regulators and determined this letter is no longer necessary and, in fact, was creating a misimpression and causing some members and providers undue concern.

As a result, we are discontinuing the dissemination of this letter going forward

You just can't make this stuff up. On one hand, underlying the sending of these letters is the irrational system the US has for providing health insurance based on employment status.

On the other hand, Blue Cross' aggressive attempts to cancel peoples' policies contradicts Wellpoint's pledged "commitments."

At WellPoint, we are dedicated to improving the lives of the people we serve and the health of our communities. From the boardroom to the mailroom, every associate is expected to honor the company's commitments to our diverse customers, fellow associates, shareholders and the communities we serve - helping us become the most trusted choice among consumers.

Our business strategies mirror our commitment to providing affordable quality care to our members and the public.

Wellpoint is becoming an amazing example of a health care company whose management seems completely hostile to its stated warm and fuzzy mission of "improving the lives of the people we serve." In the past, we have discussed how Wellpoint (and/or its units)

• misplaced a computer disc containing confidential information on 75,000 policy-holders (see post here)
• settled a RICO (racketeer influenced corrupt organization) law-suit in California over its alleged systematic attempts to withhold payments from physicians (see post here).
• was fined for cancelling individual insurance policies (again in California) after their holders filed claims (see post here)
• was found to have mis-handled at least half of its revocations of individual policies (see post here)

This sort of corporate culture and corporate leadership within health care has to be responsible for a good measure of the rising costs, poor access, and stagnant quality that are repeatedly lamented, yet seem resistant to conventional policy solutions.

Fixing this problem will require changes in the education of health care leaders, the culture of health care organizations (starting with public and enforceable commitments to ethical leadership), and unavoidably some imposition of the heavy hand of government regulation.

Such changes will provoke considerable opposition from those in the power elite of health care who have become rich and powerful under the current system. This opposition will doubtless be noisy and intimidating, given that health care's power elite has plenty of money to finance it. (Perhaps to overcome it, Governor Schwartznegger would be willing to put on his "Terminator" costume and visit a few health care CEOs to persuade them not to seek the "ratting out" of more patients.)

But as long as health care organizations' leaders are more interested in acquiring power and money than in serving patients, patients will remain at the bottom of the heap.

ADDENDUM (15 February, 2008) - On the Covert Rationing blog, DrRich noted that the first LA Times story (see above) included an assertion by Blue Cross that for a long time it had been sending many letters to doctors asking them to help the company find patients who had medical conditions not revealed on their applications for individual policies. DrRich thought that these letters had gone to physicians who were paid by capitation, and that therefore might have been motivated to have sicker patients leave their practice. If that was the case, this would suggest how perverse incentives could influence physicians to betray their core values, including making care of their individual patients their first priority, and protecting the confidentiality of patients and their medical records. However, the article noted that many physicians said they had never seen such letters before. Perhaps Blue Cross enlarged the population of physicians receiving letters. Perhaps who really got what letters when is not yet clear. In any case, it appeared that the letters asked, if not demanded physicians betray their core values. I can only hope that not too many physicians let the letters influence them to do so.

BLOGSCAN - More on Manipulation of Paxil Data

On the Clinical Psychology and Psychiatry blog, this post dissected allegations that GlaxoSmithKline manipulated data about suicidal ideation as an adverse effect of the drug Paxil (paroxetine , Seroxat in the UK ). (See our related post here.) The post concentrated on how key opinion leaders allayed fears about these advere effects based on summaries of data that had been processed by the company, data the company may have manipulated. Meanwhile, on the Scientific Misconduct Blog, Dr Aubrey Blumsohn noted how the current CEO of GSK chastised journalists for reporting on scientific data (unfavorable to the company) before scientists had looked at it, which makes more sense if the scientists to whom he was alluding were the sorts who are inclined to accept company processed data as is.

'P' is for Poor Management?

An editorial entitled 'P' is for Profit appeared yesterday about the latest Merck scandal that was mentioned in posts "What Are Those Consulting Fees and Speakers' Honoraria Really For?" and "Healthcare scandal-of-the-week: Merck settles Medicaid lawsuits." This company has a large presence in the Philadelphia region, and the editorial contains an important message:

Philadelphia Inquirer - editorials

'P' is for profit

Tue., Feb. 12, 2008

In 1952, Time magazine put Merck & Co. Inc. president George W. Merck on its cover, along with his quote: "Medicine is for people, not for profits." That admonition supposedly has guided Merck ever since. But the drug maker has run into a string of legal troubles that raise questions about the application of Mr. Merck's mantra.

... just last week, Merck agreed to pay $650 million to settle charges that it routinely cheated the federal government by overbilling Medicaid for its most popular drugs. Merck didn't admit any wrongdoing. The agreement was one of the largest health-care fraud settlements ever.

... The Medicaid case arose out of a whistleblower suit filed by a former Merck sales manager, H. Dean Steinke, who will get about $68 million. He first complained to Merck, but said his supervisor told him: "I don't care how you do it, but get the damn business."

That sure doesn't sound like putting people before profits.

I agree with that assessment; however, in the field of social informatics, we analyze social and organizational issues underlying behaviors, primarily around information and communications technologies. More broadly speaking, but in that same vein, this episode raises several social questions:

• Is the company being wrongly blamed, as opposed to an individual?
• Might the individual's actions have been based on some other motivation(s) besides greed?
• Is the company at fault in any way for this type of behaviors in employees?

Let's answer those questions.

First, I believe it is wrong to condemn an entire company for the actions of one individual, or group of individuals. Many fine, ethical people work in pharmas, including my former colleagues at Merck, who did and do take George Merck's words to heart.

Second, what might motivate a middle manager to instruct a sales manager to "get the damn business" [by any means possible]?

How about fear of layoffs and the fear of the demoralization, instability and insecurity that engenders? (Also see the post "Do Demoralizing Pharma Personnel Practices Contribute to Unsafe Drugs?")

One of Merck's strengths in promoting ethical conduct by its employees was a "social contract" that worked as follows: if you perform well, you have a secure career. In fact, prior to 2003 when a drastic cultural shift occurred, Merck had not had a mass downsizing in its 100+ year history. People could live by the George Merck creed and be assured of stability.

In November 2003, the "Equinox layoff" program of 4,400 occurred, marking a major cultural shift and a quite marked decimation of the "social contract" with employees. (Frequent announcements of further layoffs have appeared regularly in the press, and up to ~ 10,000 people have apparently been separated since the 2003 social contract termination.) In the post-layoff counseling sessions at an outplacement firm in my case, I observed a multitude of highly intelligent, capable adults up to VP level sitting at a table, highly demoralized, worried about mortgages (and foreclosure), paying tuition for kids in college, etc.

One separatee in 2003 was a former medical instructor who taught me during my residency days who was a few years older than I; his wife was ill with cancer and he had significant other expenses as well. He remained unemployed for several years until I lost touch of his whereabouts. In my own case, mid 2003 was a very bad time for hiring nationally. At age 46 at the time, it took me a full 18 months to secure new employment and all I had received was a few month's severance. I believe age discrimination is quite real. (My new position was in academia where that phenomenon is probably less common.)

Now, like most major pharma corporations, the company has reserves of billions of dollars. The endowments of major universities pale in comparison. In reality, executives do not have to continually "re-engineer" the corporation through layoffs, except to please Wall Street (and coincidentally raise their own compensation higher into the stratosphere). If greed exists, it begins in the executive suite.

Imagine a middle manager or sales representative watching senior manager shred the social contract with employees. Imagine them watching former colleagues led out the door and humiliated, to face the spectre of unemployment because "their services were no longer needed." Imagine them watching the senior executives arrange lucrative contracts and golden parachutes, while shuttling daily between PA and NJ sites and to provincial homes in a fleet of luxurious corporate heli-choppers (it costs million to maintain such a fleet), or in some cases in weekly corporate jet flights for executives who live cross-country, such as in the midwest. I am certainly annoyed by the daily sight of these choppers over my neighborhood.

Telecommunications-equipped limos are not good enough to travel the ~80 miles on the NJ turnpike or PA/NJ interstates in this culture.

In such a culture, it is perhaps understandible why a family man with a good track record might feel compelled to stretch ethical boundaries to "make the numbers" -- not out of pure greed, but in an attempt to avoid the layoff axe. As I cited from one state's Bureau of Unemployment in the post "Happy Accidents in pharma doubtful: Tax Break Used by Drug Makers Failed to Add Jobs", 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."

While I do not at all condone unethical behaviors, such behaviors by line employees to avoid a stress equivalent to a death in the family are at least understandible, contextually, outside the sphere of pure greed and/or criminality.

So, in answer to the third bulleted question above, yes, a company's sick culture does contribute to an employee's behavior. A system of dehumanizing personnel practices and perverse incentives [which can be for personal gain, or for basic social stability] affects not just senior people, but everyone.

To put people under the duress of frequent "restructuring" while senior management live it up, and expecting people to hold the line ethically is simply bad human engineering. It is a perfect setup for mayhem.

'P' is as much for Poor Human Engineering and its root causation - Poor Management - as it is for profit.

Lastly, one final provocative question:

• Can non-medical business executives who've never actually sacrificed for patient care, as any physician or nurse has, truly understand -- at a gut level -- the creed of George Merck that "Medicine is for people, not for profits?"

-- SS

Addendum: thanks to reader Steve Lucas for pointing out the extremely unfortunate story in the WSJ health blogs below. I was unaware of it when I wrote the post above. Would it be too far off the mark to suggest a connection? A 47-year-old research chemist is likely to be someone with a fair amount of seniority - and a lot to lose:

A Chemist Found Dead at a Merck Plant
Posted by Jacob Goldstein

Tue., Feb. 12, 2008

A Merck chemist was found dead this weekend, apparently after swallowing “a bit of white powder from one beaker and some liquid from another,” the Star-Ledger reports. A co-worker came across the 47-year-old man on sprawled on the floor of the research library at a company plant in Rahway, N.J. The beakers were found near his body.

A hazmat team said the substances smelled of “bitter almonds and chlorine,” according to the article. Cyanide can smell of bitter almonds, but officials have yet to determine the chemicals involved in this case.

Police are investigating the possibility of a suicide, and a Merck spokesman told the paper that the death wasn’t work-related. The man’s name hasn’t been released, and police wouldn’t say whether he left a note. About 4,300 people work in manufacturing, research and development jobs at the Rahway plant, which is open 24 hours a day, seven days a week, the Star-Ledger wrote.

Permalink

I also note this in the linked Star Ledger story:

"Merck spokesman Chris Garland emphasized today that the death was not work-related. " ... Two glass beakers containing the unknown substances were found on the floor near the man's body, [Police Capt.] Mikajlo said. He added the man, who lived in Middlesex County, appeared to have swallowed the chemicals in succession.

I should add that if this occurred in the research library (building 86, above the cafeteria), this was not a place where chemicals and beakers were present or allowed to be taken. This would seem a very deliberate act in any case. To say the death is not "work related" seems very premature.

GE: We Bring More Conflicts (of Interest) to Light

A news story in Forbes described how one manufacturer of high-tech imaging equipment, GE Healthcare, a division of General Electric, (whose current slogan seems to be "imagination at work," but whose slogan used to be "we bring good things to life,") has cranked up its marketing efforts. It included this case:

GE has spent $1 million to build a Web site and run a conference that offers architectural, legal and financial advice to anyone mulling a new imaging center.

When Mark Grossman, the head of Jefferson Radiology, which owns seven imaging centers around Hartford, wanted to buy TV advertising from cbs' Hartford affiliate, GE roped its NBC station there into giving him a better deal. The station Web site also plugged his radiologists in its 'ask an expert' service. GE gave Grossman free market research to help him determine where to situate his next center. And at a GE-sponsored conference, Grossman learned how to use direct mail to get women to come in and get their varicose veins zapped away.

Grossman's practice, which already owns $10 million worth of GE machines, is negotiating to buy the mother of all MRIs, a 30,000-gauss magnet that would cost $2 million-plus if bought.

How many conflicts of interest can one spot in this one case? Let's see:

• A device company engineering a better price charged a physician to advertise his services that would incorporate use of the companies' products.
• The device company influencing news or public service program content on a television station owned by the same conglomerate of which the device company is a part.
• The device company providing the physician free market research to help him situate an office which would use the companies' products.
• The device company supporting a conference which provides tips to the physician about marketing his services that use the companies' products.

That's four conflicts.

Note also that the second item involved stealth marketing disguised as news or public service television programming.

Again, here is one more anecdote suggesting conflicts of interest are pervasive in health care. Conflicts of interest can distort information available to patients and physicians, and provide financial incentives that risk distorting physicians' decision making.

Conflicts involving physicians and pharmaceutical companies are better known and receive more attention in the media and the medical and health care literature than other kinds of conflicts. Conflicts involving other organizations, e.g., medical device manufacturers, may turn out to be just as important.

Hat-tip to Matthew Herper at the Science Business blog.

BLOGSCAN - Contrasting Approaches to Commercial Funding of CME

On the Carlat Psychiatry Blog, Dr Daniel Carlat contrasted approaches to commercial funding of continuing medical education (CME) at two different academic medical centers. His earlier post noted that at Sloan-Kettering in New York, commercial funding of CME has been banned. On the other hand, his next post noted that at the Massachusetts General Hospital in Boston, the psychiatry department developed the "MGH Psychiatry Academy," to actively solicity big-time money from pharmaceutical companies. Whose programs will feature fancier venues, better food, and more high-tech graphics? Whose programs would you trust more?

Allegedly Conflicted Institute Director Leaves NIH

Last summer, we posted about allegations that Dr David Schwartz, then-director of the US National Institute of Environmental Health Sciences (part of the National Institutes, of Health, NIH), had several significant and previously undisclosed conflicts of interest. These included stock holdings in pharmaceutical and biotechnology companies, work as an expert witness in litigation that continued while he was director, and bringing in faculty members from the university where he previously worked full-time, while maintaining his faculty position there.

Late last Friday, Dr Schwartz's resignation was made public (but only in an email to Institute staff, in the news section of Science):

David Schwartz, the embattled director of the National Institutes of Health's (NIH’s) environmental health institute, resigned today after a stormy 3-year tenure to head a research program in Colorado.

Schwartz, a pulmonary disease researcher, drew controversy soon after he left Duke University in 2005 to head the nearby NIEHS in Research Triangle Park, North Carolina. Environmentalists, scientists, and some lawmakers protested when he wanted to privatize the institute's journal and shift funds from disease prevention to clinical studies. But the real trouble began when an inquiry by Congress revealed that Schwartz was consulting for law firms and had built up a large personal lab despite concerns from NIH ethics officials. Schwartz temporarily stepped down as director in August and had been serving in an advisory role to NIH Director Elias Zerhouni while the agency reviewed NIEHS management....

In an e-mail today to NIEHS staff, Schwartz explained that his reasons for leaving were 'simple': NIEHS 'would be more successful with new leadership,' he wrote, and he 'would have a greater impact in environmental health by working as a physician-scientist.' In addition, Schwartz wrote, 'our community has not universally embraced the scientific direction or strategies that I have implemented' and that he had 'inadvertently disenfranchised segments of our community,' for which 'I sincerely apologize.'

To what the mention of "disenfranchised segments of our community" referred is unclear, but our previous post noted reports that Schwartz's "foot-loose and fancy-free" approach to NIH rules had demoralized some institute staff.

This appears to be one small step towards reducing conflicts of interest affecting the leadership of the NIH. As we said before, such conflicts raise "concerns about whether their actions are meant to serve science and the public, or their private financial interests."

The allegations about conflicts do not seem to have affected Schwartz's reputation.

Schwartz has apparently landed on his feet. He is leaving this spring for the National Jewish Medical and Research Center in Denver, Colorado, a world-renowned center for research on respiratory diseases. He will head a new genetics research center and also direct the pulmonary and critical-care division. Gilbert Omenn of the University of Michigan, Ann Arbor, who served on a search committee that recommended Schwartz for NIEHS director, says his problems there were 'unfortunate' but that his move to Denver is 'terrific for National Jewish and terrific for him.'

As we have noted before, conflicts of interest seem to be an accepted part of "doing business" at too many academic medical centers and medical school, going hand in hand with the "show me the money" attitude of their leadership, based on the notion that faculty members' main responsibilities are to bring in more money to the institution, wherever it may come from.

Hat-tip to the Effect Measure blog.

What Are Those Consulting Fees and Speakers' Honoraria Really For?

Widely reported in the media were two large settlements reached by Merck & Co and federal prosecutors. As described by AP,

In Philadelphia, prosecutors said Merck agreed to pay $399 million for improper calculation of Medicaid rebates and bribing doctors. In New Orleans, prosecutors said the drugmaker agreed to pay $250 million for its rebate practices. With interest, that totals $671 million.

The settlement is the third largest ever for health care fraud, behind a $900 million case involving hospital operator Tenet Healthcare Corp. and a $730 million case involving hospital chain HCA, according to the group Taxpayers Against Fraud.

Whitehouse Station, N.J.-based Merck said the settlements do not constitute an admission of any liability or wrongdoing.

'What we have here is a disagreement (over) the rules of the Medicaid rebate program,' said Merck spokesman Ronald Rogers. 'These civil settlements were the best and most appropriate way to resolve these lengthy investigations.'

However, the settlement was not just about pricing.

From 1997 to 2001, prosecutors said Merck had about 15 different programs used by its sales representatives to give doctors and other health professionals 'illegal kickbacks,' disguised as fees for training or consultation, to induce them to prescribe Merck drugs.

Another AP report enlarged on this:

Prosecutors ultimately alleged that Merck paid physicians, hospitals and others excess fees to run supposed educational programs, from lunches to speaking engagements to visiting professorships, in hopes they would favor their products.

Clearly, this appears to be another in now a large series of cases in which prominent health care organizations settled charges of unethical, if not illegal behavior. The frequent appearance of such cases contributes to the impression that sleazy and unethical activities are more the rule than exception in health care, and that even the largest and formerly most reputable organizations are willing to go right up the line, and sometimes over it, in pursuit of more sales and more profits.

One feature of this case should be of particular concern to physicians and health care professionals. Drug, device, and biotechnology companies often loftily proclaim that all the money they spend to pay physicians as advisors, consultants, speakers, etc and to support myriad medical educational activities, goes to support of science and education. This case provides more evidence that consulting fees and speakers' honoraria may be meant as inducements to use and help market companies' products. Hence, at best, they are meant to support marketing, and at worst, they approach bribery.

Recall the recent case we discussed of a surgeon who admitted taking kickbacks from medical devices companies labelled as research grants and consulting fees.

Any physician of health care academic who accepts fees from commercial health care companies ought to consider whether the money is really supporting science or education, or is meant to pay for marketing or kickbacks for recommending the companies' products. In most cases, it may be hard to justify that the only purpose of the money is advancing science or education. Do physicians and other health care professionals really want to be regarded as part-time product marketers, or worse? Is the extra money really worth the shadow it throws on one's professionalism?