Tuesday, 25 March 2008

Princess Health and BLOGSCAN - Continuing Investigation of Orthopods' Financial Relationships with Prosthetic Joint Manufacturers. Princessiccia

Princess Health and BLOGSCAN - Continuing Investigation of Orthopods' Financial Relationships with Prosthetic Joint Manufacturers. Princessiccia

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.
Princess Health and BLOGSCAN - Imperial Pharmaceutical CEOs. Princessiccia

Princess Health and BLOGSCAN - Imperial Pharmaceutical CEOs. Princessiccia

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, 21 March 2008

Princess Health and Who Was Responsible for the Purity of Baxter International's Heparin?. Princessiccia

Princess Health and Who Was Responsible for the Purity of Baxter International's Heparin?. Princessiccia

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.
Princess Health and BLOGSCAN - Labor Union Helps to Market Lipitor. Princessiccia

Princess Health and BLOGSCAN - Labor Union Helps to Market Lipitor. Princessiccia

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, 19 March 2008

Princess Health and Fake Heparin, then Sick and Dead Patients. Princessiccia

Princess Health and Fake Heparin, then Sick and Dead Patients. Princessiccia

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.
Princess Health and The wages of complacency in defining "Medical Informatics" as a specialty. Princessiccia

Princess Health and The wages of complacency in defining "Medical Informatics" as a specialty. Princessiccia

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, 18 March 2008

Princess Health and The Peril to Leaders "Who Accept Their Own Myth". Princessiccia

Princess Health and The Peril to Leaders "Who Accept Their Own Myth". Princessiccia

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, 17 March 2008

Princess Health and Living the High Life in Academic Medical Center Leadership. Princessiccia

Princess Health and Living the High Life in Academic Medical Center Leadership. Princessiccia

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.'

Instead,

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

Also,


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, 14 March 2008

Princess Health and Hacking an ICD - A Dual Medical Informatics/Ham Radio Perspective. Princessiccia

Princess Health and Hacking an ICD - A Dual Medical Informatics/Ham Radio Perspective. Princessiccia

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.

Indeed.

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, http://www.eham.net/reviews/detail/816) 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", http://www.treehugger.com/files/2007/08/a_talk_given_at.php):

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 (http://en.wikipedia.org/wiki/WWVB) 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
Princess Health and Hacking an ICD. Princessiccia

Princess Health and Hacking an ICD. Princessiccia

Implantable cardiac defibrillators (ICDs) are battery-powered, computerized electronic devices implanted in the body. They are designed to detect dangerous heart rhythms and administer a shock to the heart to stop these them. We have discussed these devices before, including a story about how one manufacturer suppressed data that suggested some of their ICDs were less reliable than heretofore thought.

It appears that a new, and potentially worrisome adverse effect of these devices has just been discovered.

An article to be published in the IEEE Symposium on Security and Privacy [Halperin D, Heydt-Benjamin TS, Ransford B et al. Pacemakers and implantable cardiac defibrillators: software radio attacks and zero-power defenses. IEEE Symposium Security Privacy 2008; in press. Link here.] demonstrated the vulnerability of an implantable cardiac defibrillator to computer hacking.

Let me set the stage. ICDs, and other implantable devices may need to be tested, and sometimes their functional parameters need to be adjusted. Obviously, it would be cumbersome and hazardous to remove such a device after it was implanted to check and adjust it. So the devices incorporate methods to check and adjust them remotely. It appears most do so using "wireless" means. Wireless, of course, is the traditional UK term for radio.

Halperin et al found that they could communicate with a representative ICD, the Medtronic Maximo DR VVE-DDDR model via radio. Note that the ICD they tested was not implanted in a patient, but sitting on a bench, and that their radio equipment used to "hack" it was in close proximity to it.

Once they figured out how to communicate, the found that they could:
- Discover patient data such as name, date of birth, medical ID number, and medical history
- Monitor electrophysiological telemetry data
- Turn off specific ICD functions
- Induce the ICD to deliver a shock, potentially one that could cause a severe rhythmn disturbance
- Increase the power consumption of the ICD so that its battery would fail prematurely.

Further, they found that they could overcome a design feature of the ICD meant to prevent anyone from communicating with it from more than a very short distance. The ICD is not supposed to respond to radio signals unless it is first exposed to a strong local magnetic field which triggers a magnetic switch in the device. But the investigators found, "in order to rule out the possibility that proximity of the magnet ... is necessary for the ICD to accept programming commands, we tested each ... attack with and without a magnet near the ICD. In all cases, both scenarios were successful."

Thus, this article suggested this ICD could be hacked, and that hacking it could pose significant risks to patients who had the ICD implanted.

Some people doubted that such hacking could actually take place in real-life, as opposed to laboratory settings. For example, per the AP story, FDA spokesperson Pepper Long "acknowledged a hacker could use specialized software and a small antenna to intercept transmissions from a defibrillator. But she said the chance of that happening � or of a defibrillator being maliciously reprogrammed using a technique similar to the one a doctor would use to program it � was 'remote.'" Furthermore, per the Reuters story, "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."

In my humble opinion, however, the problems that Halperin et al found with the Medtronic ICD have real importance. Let me first note that both the FDA and Medtronic representatives treated the issue epidemiologically. They based their pronouncements on the assumption that an adverse event that has not happened in the past due to a device in wide use is not likely to happen in the future. That does not make sense if the potential adverse event would involve conscious, malicious human action. Just because hackers have not yet attacked an ICD does not mean they will not do so in the future, especially after the possibility of doing so has gotten wide publicity.

Another way some have minimized the practical importance of their findings is that the experiment by Halperin et al was carried out on an ICD on a bench, using equipment that was in close proximity. Some may thus feel that the possibility of hacking carried out from longer range is low. I strongly believe that is not a good assumption. Many features of the ICD and its radio communication system suggest that hacking could be carried out from considerably longer range. There are hints in the Halperin et al article that could suggest to anyone moderately knowledgeable about radio how this could be done. I do not want to discuss these in any more detail, because I do not want to facilitate such long-ranging hacking. But I believe it is a real danger.

But why is this relevant to Health Care Renewal? It seems glaringly obvious that the risk of hacking could have been substantially reduced had the ICD been designed so it would not respond to any radio communication that did not have an appropriate authorization code, and/or if communication with it were encrypted. In fact, Halperin et al suggested some relatively simple measures that could be used to increase the security of these devices. Yet the Medtronic ICD, and presumably other ICDs and implantable devices, were not designed with such elementary security precautions in mind. As security expert Bruce Schneier wrote (reported in Information Week),

Of course, we all know how this happened. It's a story we've seen a zillion times before: The designers didn't think about security, so the design wasn't secure.

But 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. The most charitable explanation for why they did not think to do so is that they really did not understand the clinical context in which this device would be used.

This is yet another reminder that those who run health care organizations often fail to think about patients' welfare first instead of other considerations. We need to change the culture of health care organizations to put patients first. Until we do so, we are going to get hacked.

Wednesday, 12 March 2008

Princess Health and Article Ties Together Pogo and Anechoic Effects. Princessiccia

Princess Health and Article Ties Together Pogo and Anechoic Effects. Princessiccia

Ever wonder how the anechoic effect--why many, especially in the academy, sit idly by when questionable practices emerge from industry--fits in with the Pogo Effect ("we have met the enemy and he is us")?

In the article, "Allied Against Reform: Pharmaceutical Industry-Academic Physician Relations in the United States, 1945-1970," forthcoming in the Bulletin of the History of Medicine, but in March 2008 available (after registration) for download in preprint here , Dominique Tobbell of Penn and the Chemical Heritage Foundation supplies some of the connective tissue.

In this exceptionally well-researched article Tobbell argues convincingly that pharmaceutical reform in the 1960s was very much in the air--so much so that industry sought concertedly to create new alliances to blunt its impact. Capitalizing on concerns, not just within the AMA but also in the academy, about government oversight, industry representatives found new alliances in both places.

An expert advisory body, the Drug Research Board, to "guide government officials on pharmaceutical policy," was the result. "By positioning themselves as pharmaceutical experts, this alliance circumvented the FDA�s new authority," she argues, "[challenging] the efforts of pharmaceutical reformers to further increase the government�s role in drug development and practice."

Tobbell shows that the impulse to forge these alliances came, not just from industry, but also from the most rarefied reaches, such as Harvard, as early as the 1940s. When it became apparent that the government's influence on research was the Next Big Thing, individuals in both places, industry and medical schools, made common cause, she shows, to limit the authority of the FDA.

(Of course, the academy played on both sides. Funding is funding.)

Tobbell shows how it all came to a head in the more reformist 1960s and '70s, with issues swirling not just around research but around the then-emerging threats to directly-impacted revenue streams, such as proposals in favor of generic drug-substitution legislation.

Echo, anyone?

Well worth reading.

Tuesday, 11 March 2008

Princess Health and BLOGSCAN - Key Opinion Leaders. Princessiccia

Princess Health and BLOGSCAN - Key Opinion Leaders. Princessiccia

On the Clinical Psychology and Psychiatry blog is a pithy discussion of the use of "Key Opinion Leaders," (KOLs) to provide a veneer of apparent respectability to drug marketing. One KOL claimed, "trust me. I don't make that much," but it turned out had been paid $180,000 over two years to give talks about childhood bipolar disorder, a disease whose existence ought to be controversial.
Princess Health and BLOGSCAN - Throwing Money at Zetia Marketing. Princessiccia

Princess Health and BLOGSCAN - Throwing Money at Zetia Marketing. Princessiccia

On the Question Authority blog, Dr Peter Rost takes some time off from having fun discussing the Emperors Club VIP, i.e., the organization which NY Governor Eliot Spitzer allegedly patronized, to his downfall, to address Schering-Plough's alleged new marketing campaign for Zetia. He has a great anonymous post from someone who may be a Schering-Plough drug rep, "throwing money at a problem is not the way to fix things - it will only make matters worse. Have the company come clean about the study, give us some good (or even not so good) evidenced based medicine - and let us earn back the business the right way." Hear, hear.

Monday, 10 March 2008

Princess Health and Cancer Screening, CT Scans, and Patent Applications. Princessiccia

Princess Health and Cancer Screening, CT Scans, and Patent Applications. Princessiccia

We are getting to this story a bit late, but perhaps can provide some new insight.

In 2006, an article that supported the value of CT scans to screen for lung cancer caused quite a stir. [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.]

The article reported a case series of over 30,000 patients who were entered into a program using annual CT scans to screen for lung cancer. Over 10 years of enrollment, 484 patients were found to have cancer. The investigators estimated the10-year lung-cancer specific survival of these patients was 80%, concluding "annual spiral CT screening can detect lung cancer that is curable."

A few days later, the article's lead author, Dr Claudia Henschke, was quoted in the New York Times as not understanding why CT screening was not the standard of care, "'I don�t get what the resistance is,' Dr. Henschke said. To her, it is a matter of simple logic: the earlier cancer is found, the better the odds of a cure. CT finds lung cancer early. So why not use it?"

In line with that sentiment, advocacy for widespread screening using CT scanning has continued under the auspices of the Lung Cancer Alliance. (See their news release, "Lung Cancer Alliance stands behind CT screening for lung cancer" from last fall.) The LCA asserted, "the mounting evidence which continues to mature from the largest international, protocol-driven screening effort (I-ELCAP) [is] showing that CT screening in a high risk population has the potential to reverse the current 15% five year survival rate." Furthermore, as reported in the May 4, 2007 edition of the Cancer Letter, legislation providing funding for screening using I-ELCAP protocols has been introduced in several state legislatures.

Of course, this seems to be another example of the introduction of an expensive, high-technology intervention that could save lives, but once again driving up the already staggering cost of health care. But these sorts of advances seem inevitable, don't they?

Maybe not. Dr Henschke's enthusiasm for screening seemed to go well beyond the data her study provided. In fact, the multiple flaws of the study were nicely summarized in a special article in the Archives of Internal Medicine [Welch HG, Woloshin S, Schwartz LM et al. Overstating the evidence for lung cancer screening: the International Early Lung Cancer Action Program (I-ELCAP) study. Arch Intern Med 2007; 167: 2289-2295. Link here.]


  • A Case-Series, not a Randomized Controlled Trial - Because the study did not contain a control group, it is impossible to tell whether its apparently favorable results were due to the intervention, to the selection of patients with unusually good prognoses, or to chance. As Welch et al put it, "The I-ELCAP study design is a case series. Because there was no control group, readers cannot know what would have been observed in the absence of screening."
  • Lead-Time Bias - The major result of the NEJM study was that patients with cancer seemed to live longer after their diagnosis than experience suggests is the norm for lung cancer patients. However, this could have been due to lead-time bias. Per Welch et al, "because survival is measured from the time of diagnosis, any screening test that advances the time of diagnosis will bias the measure of survival�the lead-time bias." For example, consider a person who developed cancer at age 60, was diagnosed at age 65, and died at age 66. His survival after diagnosis was one year. But if he had been diagnosed at age 60, and died at age 66, his survival after diagnosis would have been six years, but his life-span would not have been altered.
  • "Overdiagnosis Bias" - This means that more intensive efforts at diagnosis may reveal cases of disease with more favorable prognoses. For example, it is well known that some patients who appear to have early prostate cancer will never have progressive disease. But detecting such patients by screening will not improve their survival. Welch et al noted that previous studies that used chest x-rays to screen for lung cancer demonstrated improved survival after diagnosis, presumably as a result of combined lead-time and overdiagnosis biases, since overall survival was not improved in patients who were screened compared to controls.
  • Failure to Assess Harms of Screening and Subsequent Treatment - Welch et al noted problems with how the I-ELCAP study assessed deaths due to surgical treatment of cancer. The study also failed to report adverse effects of invasive diagnostic efforts for patients who had positive CT scans, most of whom did not prove to have cancer. For example, needle biopsy of lesions found by CT scan can cause pneumothorax (lung collapse), but these events were not reported in the NEJM article.

Also, a series of letters to the editor of the NEJM brought up similar concerns, plus additional flaws, e.g., although the I-ELCAP study reported 10-year disease specific survival, it only followed patients for a median of 40 months, and less than one-fifth of subjects were followed for five years or more. A response by lead author Henschke and two other authors failed to reassure. It first seemed to simply deny the importance of lead-time bias,

Screening for cancer is supposed to provide for lead time in diagnosis and treatment. A bias is introduced when one compares relatively short-term survival rates as of diagnosis to assess the effectiveness of treatment with lead time relative to treatment without lead time. We did not do this.


Henschke et al also seemed to misunderstand overdiagnosis bias. They responded to the relevant critique by asserting that all cases of cancer were confirmed by pathology. This begged the question, because pathological diagnosis does not necessarily determine whether a tumor will progress.

Finally, they seemed to deny that randomized controlled trials are necessary to assess screening programs.



Berg and Aberle remark that our study had no comparison group, but unlike interventional research, diagnostic research does not inherently require a comparison, much less a comparison group. The attainable frequency of diagnoses of stage I tumors can be assessed only in the framework of screening, and our principal diagnostic result was the 85% frequency of diagnoses of clinical stage I tumors among all diagnoses. The principal interventional result was the 92% cause-specific 10-year survival rate after prompt treatment of stage I tumors. The relevant comparison group would consist of patients who received early diagnoses but were treated late, principally to learn about the timing of deaths from lung cancer.


Every scientist tends to be an enthusiast about his or her own work, but I was struck by how Henschke et al seemed to shrug off their study's obvious methodologic problems.

(It might seem to be beating a dead horse, but I found even more problems with the I-ELCAP article beyond those noted above: failure to describe the clinical characteristics of the patient population; not blinding assessment of whether deaths were cancer-related; failure to have a credible method to verify that patients who did not have a positive CT scan did not have cancer; and failure to report loss to follow-up.)

More concerns about the origins of the I-ELCAP investigators' enthusiasm, which seems to have infected such groups as the Lung Cancer Alliance, were raised by a new report in the Cancer Letter, (from Jan 18, 2007, but not available without a subscription, and just made available to me last week),



The leaders of a research consortium that advocates computed tomography scanning to detect early-stage lung cancer have built an estate of 27 patent applications worldwide covering technologies and methods of screening.

According to publicly available databases, the leaders of the International
Early Lung Cancer Action Project are listed as inventors on patent applications
and one issued U.S. patent that cover innovations in lung cancer screening,
from clinical trial methodology, to software for interpretation of scans, to
technology of biopsy needles.


The first of these patent applications was submitted on April 11, 2000. In the U.S., group leaders are listed as inventors on one patent and 10 published applications. At least one of the inventions has been licensed by General Electric, a maker of CT scanners, and, in another instance, patent rights were reportedly exchanged for stock of a start-up company that markets lung biopsy devices.

Disclosure statements that accompanied the publications by the group�s leaders didn�t reflect these activities as potential conflict of interest, a literature
search shows
.

Furthermore,



Both GE and Cornell declined to disclose the details of a licensing agreement covering Henschke�s and Yankelevitz�s inventions.

'We do have a license agreement with the Cornell Research Foundation for certain CT lung cancer patents,' Corey Miller, a spokesman for GE Healthcare Americas,
said to The Cancer Letter.

'The researchers�Henschke and Yankelevitz� have received some royalty payments from GE for a computer algorithm equation that they developed to detect lung cancer on diagnostic scans,' Miller said. 'That is, as far as I know, the extent of our relationship with those two.'

Note that the 2006 NEJM article included no disclosures of conflicts of interest.

Finally, the Cancer Letter noted that I-ELCAP investigators have worked actively with the Lung Cancer Alliance to promote screening.



As they spar with skeptics, I-ELCAP scientists work closely with LCA, a group that advocates for screening former and current smokers in accordance with I-ELCAP protocols.


So here we go again. Flawed research that supports an expensive, high-technology intervention for which millions of people would be eligible appears in a major journal. The intervention is hyped in news articles, and by a grass roots patient advocacy group. Politicians soon jump on the bandwagon. Citing the potential for saving lives, enthusiasts ignore the flaws in the data that started it all. Only much later do we find out that the researchers who wrote the flawed study may stand to make money if the high-technology intervention is widely adopted.

At the minimum, this case suggests that academic medicine's current method of managing conflicts of interest through disclosure is not working well. Further, in the absence of such disclosure, it seems that individual clinical decisions and public policy may too often be based on apparently unbiased research that in fact is being purveyed not merely by enthusiasts, but by people who may make more money when the results turn out a certain way.

People have been wringing their hands about ever rising health care costs for a long time. Expensive high-technology interventions are often cited as responsible, but not further addressed, apparently due to the assumption that their costs are an inevitable reflection of their advantages. Yet maybe this is not so inevitable. We may have placed to much credence in research that exaggerated the value of high tech gizmos because it was done by by people who stood to gain from the sale of such gizmos.

At the very least, we need to make sure we know when clinical research to evaluate screening methods, diagnostic tests, drugs, or devices was done by people with financial interests in their success. It might be, however, that the only way to get unbiased evaluations of drugs and devices is to have the evaluation done by people who have no financial interest in the results turning out one way or the other.

See this editorial in the Boston Globe by Dr Jerry Kassirer, and this post in the WSJ Health Blog for earlier discussion of what the Cancer Letter revealed.

ADDENDUM (11 March, 2008) - See also previous comments after publication of article by Welch et al by Merrill Goozner in GoozNews blog.

Friday, 7 March 2008

Princess Health and British Government Concludes GSK Suppressed Paxil (Seroxat) Data. Princessiccia

Princess Health and British Government Concludes GSK Suppressed Paxil (Seroxat) Data. Princessiccia

Last year, we summarized the results of a BBC investigation broadcast on the television program Panorama that charged that GlaxoSmithKline "distorted trial results of an anti-depressant, [Seroxat in the UK, Paxil in the US, chemical name paroxetine] covering up a link with suicidal teenagers." (See also the links in that post to extensive discussion on the Clinical Psychology and Psychiatry Blog.)

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has just completed an investigation, and it is fitting to quote the BBC story about its results.

It comes after the drugs regulator announced GlaxoSmithKline would not face criminal proceedings over claims it withheld information on Seroxat.

But they warned GSK should have been quicker to raise the alarm on the risk of suicidal behaviour associated with the antidepressant in the under-18s.

GSK has rejected claims it improperly withheld drug-trial information.

The Medicines and Healthcare products Regulatory Agency (MHRA) received data from clinical trials in May 2003 showing that patients under 18 had a higher risk of suicidal behaviour if they were treated with Seroxat than if they received a placebo.

Data also showed that Seroxat was not effective for treating depression in children and adolescents.

But Professor Kent Woods, MHRA chief executive said they were disappointed GSK had not given them information earlier and that drugs firms had an "ethical responsibility".

"I remain concerned that GSK could and should have reported this information earlier than they did.

"All companies have a responsibility to patients, and should report any adverse data signals to us as soon as they discover them.

The government decided not to pursue criminal charges, mainly because of "important weaknesses in drug safety legislation in force at the time."

Also,

Health minister Dawn Primarolo said the government would take immediate steps to secure a strengthening of the law in the UK and Europe.

She also said they wanted to make it clear to all pharmaceutical companies that, "notwithstanding the limitations that may exist in the law, they should disclose any information they have that would have a bearing on the protection of health".

The Guardian reported the forceful opinions of the [UK] Mental Health Foundation chief executive, Andrew McCulloch,

It is totally unacceptable to hear that, when information can be made available at speed, young people may have taken their own lives due to a lack of transparency by a pharmaceutical company.

Woods further commented in another article in the Guardian,

I really feel there is an ethical obligation that pharmaceutical companies ought to recognise and it seems to have been lost. Twenty years ago I was a prescribing doctor and I took it for granted that if there was information relevant to the drug I was going to prescribe, then it would be available. We're talking about something which has direct relevance to health and safety.

The Guardian also noted that Woods "could not rule out the possibility that other companies were sitting on unpublished data that could cause them commercial damage."

So, in case there was any doubt, based on this UK government report, it seems very clear that GSK suppressed data about the adverse effects of Seroxat in an effort not preserve sales. This was a blatant effort to put company profits ahead of patient well-being and a slap at the integrity of the clinical science data base. This has hardly been the only case of suppression of clinical research data because it reflected poorly on some company's products or services.

And pharmaceutical executives wonder why no one trusts them anymore?

I doubt there is any way to secure the integrity clinical research short of banning all involvement by corporations with vested interests in having specific research studies come out in ways that favor their products or services.

See also the forceful comments by Dr Aubrey Blumsohn on the Scientific Misconduct Blog. He called it "a day of shame."

Thursday, 6 March 2008

Princess Health and Fat Chance: Conflicts of Interest and Calorie Counting. Princessiccia

Princess Health and Fat Chance: Conflicts of Interest and Calorie Counting. Princessiccia

Stephanie Saul in the New York Times, and Karl Stark in the Philadelphia Inquirer have covered the curious story of the downfall of the president-elect of the Obesity Society. Last month, Ms Saul set the stage,


New York City�s new rules for menu labels at chain restaurants have set off a food fight among the nation�s obesity experts.

Most support the theory of the city�s health commissioner that forcing chain restaurants to list the calories alongside menu items � flagging that a Double Whopper With Cheese has 990 calories, for example � will make patrons think twice about ordering one. The rules are set to take effect at the end of March.

There is a countertheory, however, set forth by Dr. David B. Allison, the incoming president of the Obesity Society, a leading organization of obesity doctors and scientists. An affidavit he recently submitted to the United States District Court for the Southern District of New York has ignited a controversy within his organization.

In the filing, Dr. Allison argues that the new rules could backfire � whether by adding to the forbidden-fruit allure of high-calorie foods or by sending patrons away hungry enough that they will later gorge themselves even more.

It might be only a scientific debate among nutrition experts, except for the fact that Dr. Allison was paid to write the document on behalf of the New York State Restaurant Association, which is suing to block the new rules.

Dr. Allison�s role in the debate has angered some members of the Obesity Society, setting off an e-mail fury since word of his court filing began to circulate. Some have pointed to Dr. Allison�s other industry ties, which have included advisory roles for Coca-Cola, Kraft Foods and Frito-Lay.

Many of the group�s 1,800 members are �completely mad that a president-elect of the Obesity Society, an organization that cares about obesity and cares about healthy eating, wants to hold back information from people that helps them make healthy choices,� said Dr. Barry M. Popkin, a member of the organization, who is director of the Interdisciplinary Obesity Center at the University of North Carolina, Chapel Hill.

Dr. Allison, a professor of biostatistics and nutrition at the University of Alabama, Birmingham, is scheduled to start a one-year term as president of the Obesity Society in October. He has defended his affidavit. In a telephone interview, he said he did not take a position for or against menu labeling in the document but merely presented the scientific evidence that the labeling might deter over-eating but might not and, in fact, might be harmful.

He also defended his work for the restaurant industry, but would not disclose how much he was paid for his efforts.

�I�m happy to be involved in the pursuit for truth,� Dr. Allison said. �Sometimes, when I�m involved in the pursuit for truth, I�m hired by the Federal Trade Commission. Sometimes I help them. Sometimes I help a group like the restaurant industry. I�m honored that people think my opinion is sufficiently valued and expert.�

The executive vice president for the restaurant association�s metropolitan New York chapters, E. Charles Hunt, said that Dr. Allison was retained by the association�s lawyers. �Obviously, a lot of it was in favor of our position,� Mr. Hunt said, �although he didn�t come right out and say that.�


So this sounds like yet another story about conflicts of interest, and their possible effects influencing the publicly expressed opinions of a prominent academic. As usual, the conflicted party angrily denied that his financial relationships could have affected his scientific judgment. As we have noted before, this is undoubtedly a sincere belief, but psychological evidence and common sense suggests that having financial ties to organization x may influence one to take positions in line with organization x's interests, even if these influences do not reach conscious thought.

The variant here seems to be that the academic had a financial relationship not with a drug, biotechnology or device company, the usual suspects, but with an association of restauranteurs.

But wait, Mr Stark added more in his story in the Philadelphia Inquirer,

The relationship between academic researchers and industry is a front-burner issue in many fields. Several congressional inquiries are looking at drug-firm support for the American College of Cardiology, the national cardiology group, and the American Heart Association.

Compared with those groups, the Obesity Society, based in Silver Spring, Md., would seem like a tiny outpost with its $2.1 million budget. But the group's 1,800 members include many influential researchers, physicians and dietitians.

The society relies heavily on industry money, raising about $1 million in the last year from various companies, said Morgan Downey, the group's executive vice president. The biggest corporate donors were drugmakers sanofi aventis, GlaxoSmithKline and Allergan as well as the health-care conglomerate Covidien, he said.

About $230,000 of the corporate money funded a conference in September for health advisers to presidential candidates, Downey said.

Fast forward to this week, when Ms Saul reported in the New York Times that Dr Allison is giving up his leadership position for the Obesity Society,


A dispute over food industry influence has resulted in the resignation of the incoming president of the Obesity Society.

Dr. David B. Allison, who was to take over the society, a national group of obesity doctors and researchers later this year, submitted his resignation from that position on Friday.

So what happened? Did the Obesity Society cast out a leader because he had conflicts of interest that interfered with his ability to advance science, education and clinical practice? Or did the Obesity Society cast out a leader because he was aligned with commercial interests opposed to the commercial interests that provide most of the society's support? That is, was he cast out not because he had conflicts of interest, but because he did not have the same conflicts of interest as the society?

Who can tell?

Once again, this case is an illustration of the pervasiveness of conflicts of interest affecting health care organizations. It also shows how the pervasiveness of such conflicts sometimes makes it impossible to discriminate debates about science and health policy from the claims of conflicting pitchmen.

Full disclosure of these conflicts beforehand would at least have given warning that the nature of the debate was ambiguous.

But to figure out the best answer in the current policy debate, that is, whether it really is a good idea to have legislation to put calorie counts on restaurant menus, would really require the input from people who are not paid by either restauranteurs, or those selling obesity treatments. Fat chance that will happen soon.
Princess Health and Money for Nothing: More Guilty Pleas at UMDNJ, but Anechoic Effect Continues. Princessiccia

Princess Health and Money for Nothing: More Guilty Pleas at UMDNJ, but Anechoic Effect Continues. Princessiccia

We have done a long series of posts about the troubles at the University of Medicine and Dentistry of New Jersey (UMDNJ), the largest US health care university. The university was operating under a federal deferred prosecution agreement under the supervision of a federal monitor (see most recent posts here, here, here, here and here.) We had previously discussed allegations that UMDNJ had offered no-bid contracts, at times requiring no work, to the politically connected; had paid for lobbyists and made political contributions, even though UMDNJ is a state institution; and seemed to be run by political bosses rather than health care professionals. (See posts here, and here, with links to previous posts.) More recent were some reports of amazingly wasteful decisions by UMDNJ managers leading to spending millions of dollars for real-estate that now stands vacant (see post here). There was the indictment of a powerful NJ politician for getting a no-work job in the system, and the indictment of the former dean of the university's osteopathic medicine school for giving him the job (see post here). We found out that UMDNJ had named one of its teaching hospitals for a pharmaceutical company in 2001 (see post here), that the federal monitor accused the dean of one of the UMDNJ campuses of fixing students' grades (see post here), and that the monitor found even more bizarre financial practices at the university (see post here). Although the monitoring ended this year, his most recent report found previously undisclosed problems with the university's research compliance (see post here).

Over a year ago, it was reported (see post here with links to previous posts) that UMDNJ gave paid part-time faculty positions to some community cardiologists in exchange for their referrals to the University's cardiac surgery program, but not in exchange for any major academic responsibilities. Last week, the Newark Star-Ledger provided some f0llowup,

Two cardiologists yesterday admitted signing on to high-paying, no-show jobs at the state's medical university in return for funneling patients to the school's troubled heart surgery program.

As part of the kickback scheme, the two were hired as clinical assistant professors at the University of Medicine and Dentistry of New Jersey, despite having no research credentials. They gave no lectures, taught no classes and acknowledged that they essentially did nothing more than refer patients for cardiac procedures while receiving hundreds of thousands of dollars in salary over three years.

The doctors -- Bakul Desai, 52, of Livingston and Laxmipathi Garipalli, 59, of Colts Neck -- are cooperating with the U.S. Attorney's Office and the FBI in a two-year criminal investigation that so far has implicated more than a dozen other part-time cardiologists and several top UMDNJ administrators. The scheme was hatched as part of an increasingly desperate effort to beef up a failing cardiac surgery program then on state probation, according to court records and reports by a federal monitor.

No university officials or any other physicians have been charged, although UMDNJ's chairman of medicine was forced to step down after the initial revelations became public.

In proceedings yesterday before U.S. District Judge Stanley R. Chesler in Newark, the doctors pleaded guilty to embezzling approximately $840,000 in payments from the university. The physicians stood quietly, answering questions with simple 'Yes' or 'No' answers. Both face possible jail time and suspension or revocation of their medical licenses.

U.S. Attorney Christopher Christie said others will be held accountable.

'UMDNJ has a culpable role in all of this,' Christie said. 'Don't take from these two guilty pleas today (the idea) that the institution itself is off the hook, because I will say quite clearly it is not.'

A university spokeswoman said UMDNJ and its board have 'worked aggressively' to restructure and reform the community cardiology program since concerns were first raised in 2006, including a reduction in the number of community cardiologists and changes in salaries and reporting requirements.

Desai and Garipalli should have known from the start that they were taking money for doing nothing, Christie said.

'They continued to do nothing and they continued to get paid in what is a classic New Jersey no-show government job scam,' Christie said during a news conference afterward. 'Extraordinary fraud and waste and abuse and illegality that was occurring with public money at UMDNJ.'

So here is even more documentation about the muck in which UMDNJ is mired.

We will wait and see whether there are more criminal charges in this case. In cases of health care corruption, it often seems that any penalties incurred affect those lowest on the totem pole, in this case, the two unfortunate cardiologists. Those higher up all too often get to walk away. This suggests how health care has come to be run by a power elite that do not have to follow the rules to which mere mortals are subject. I hope Mr Christie is able to buck this trend.

In the UMDNJ case, it seems obvious that someone in the management of UMDNJ had to have been involved in this scheme. It is hard to see how it could have occurred otherwise. So we wait and see if any such people are identified, much less convicted.

Another striking feature of the UMDNJ case is its manifestation of the anechoic effect. I put in a fairly long summary above at the beginning of this post emphasizing the magnitude, importance, and complexity of this case. I did so because many people, including many health care professionals and health policy makers, may be totally unfamiliar with the UMDNJ case. It has only been discussed in the news media in New Jersey (and to some extent the neighboring states of New York and Pennsylvania) and in Health Care Renewal. It has not, repeat not ever been discussed in any medical, health care, health services research, or health policy journal. It has not, repeat not appeared in any prominent medical. (I repeated the relevant searches today, of Medline, Google Scholar, and of the American Medical News, JAMA, and MedPage.)

An entire health care university admitting guilt, being subject to a deferred prosecution agreement, operating under a federal monitor, while all sorts of mismanagement and unethical behavior were uncovered, and NO ONE thinks it is worthy of discussion in any medical, health care, health services research, or health policy journal or newsletter?

The anechoic effect lives. And as long as it lives so vigorously, we make no progress in attacking the pervasive mismanagement, conflicts of interest, and outright corruption afflicting the management of health care. If we cannot even talk about these problems, how are we going to solve them?

Talking about them, however, might disturb the power elite that personally profits so much from their domination of health care. Hence, most health care professionals who are lower in status realize that to even mention such topics in public is to imperil one's career.

But as long as we cannot discuss the recent unpleasantness, things will continue to get even more unpleasant.

Fight the anechoic effect. Take back the future.