Unequal Justice Under Law - Comparing Cases of Alleged Misbehavior by Large Health Care Organizations and Individuals

How the wealthy and powerful have become able to play by a different set of rules than those affecting ordinary people may be the defining issue of our time.  Yesterday, President Obama's State of the Union message asked for an economy in which "everyone plays by the same set of rule."  We posted about how this issue, which got national attention due to the Occupy movement, affects health care here.

We have previously posted again and again about how the penalties for misbehavior by large US health care organizations seem to be so minimal as to be incapable of deterring future bad behavior (e.g., see posts about legal settlements).  At most, corporations often pay fines that are no more than a cost of doing business.  They rarely have to admit guilt, and when they do, it is usually to a relatively trivial charge.  The people who authorized, directed, or implemented the bad behavior almost never suffer any negative consequences.  Thus, the leaders of large US health care organizations seem to have impunity.

Similar complaints have been made about the lack of accountability of the leaders of the finance firms that lead us into the global financial crisis, or great recession. 

However, while I have reviewed now hundreds of stories about such minimal organizational punishments, I have also seen hundreds of stories discovered by my automatic news searches of much more severe penalties paid by individuals who have been accused of similar misbehavior.  I have never previously made an explicit comparison of how health care corporate and individual misbehavior are handled.

A recent set of examples of organizational misbehavior invites such a comparison.  Here they are, in chronological order.

KV Pharmaceutical

On December 6, 2011, the St Louis Post Dispatch reported:

KV Pharmaceutical Co. has agreed to pay $17 million to federal and state authorities to settle Justice Department allegations that it defrauded federal health care programs.

The settlement resolves allegations that KV, as the Bridgeton-based parent company of now-defunct Ethex Corp., misrepresented the regulatory status of two of its drugs that did not qualify for coverage under federal health care programs, the Justice Department said today.

The Justice Department alleges that Ethex submitted false quarterly reports to the federal Centers for Medicare and Medicaid Services related to the two drugs: nitroglycerin extended release capsules and hyoscyamine sulfate extended release capsules.

Company leadership made the usual sort of comment. CEO Greg Divis said:

The closure of this matter is another step forward as KV moves ahead as a women's healthcare focused branded specialty pharmaceutical company.

Corporate leaders seem to love putting such unpleasantness in the past and moving on, especially when they personally are not held accountable for the previous misbehvior.

Note that this is just the latest settlement for KV Pharmaceutical:

KV shut down Ethex after the subsidiary pleaded guilty in March 2010 to two felony counts of criminal fraud for failing to report to the Food and Drug Administration that it was making oversize drugs - and drew $27.6 million in fines and restitution.

Catholic Healthcare West, Sutter Health

On December 8, the Sacramento Bee reported:

Two of Sacramento's biggest health care players paid a combined $2.3 million to the federal government to settle allegations that 61 of their hospitals double-billed Medicare for therapies and services, U.S. Department of Justice officials announced Wednesday.

Catholic Healthcare West paid more than $875,000 and Sutter Health nearly twice that – more than $1.43 million – for alleged duplicate charges for infusion therapies and treatments to break up kidney and bladder stones, in what Lauren Horwood, a spokeswoman in the Sacramento U.S. attorney's office, called 'a significant settlement.'

As usual,

Officials at the two health networks admitted no wrongdoing in agreeing to the settlement, Horwood said. No charges will be filed.

Again, however, this was not the first such issue to affect these large non-profit organizations:

In 2006, Sutter Health agreed to grant discounts and refunds to uninsured patients the network was accused of overcharging, stemming from a 2004 class-action lawsuit.

Blue Shield (California)

On December 29, 2011, the Los Angeles Times reported:

More than a year after the healthcare reform law sought to prevent sick patients from losing medical coverage, insurers are still paying for their alleged abuses.

Blue Shield has agreed to pay $2 million to resolve accusations that the company improperly dropped policyholders after they got sick and needed expensive treatment.

The settlement, announced Wednesday by Los Angeles City Atty. Carmen Trutanich, ends an investigation into more than 1,000 so-called rescissions by Blue Shield, a San Francisco-based not-for-profit company.

As usual, there was no admission of guilt, and a company spokesperson claimed that while the company decided to pay out the money in response to the allegations, it, of course, was blameless:

Blue Shield spokesman Steve Shivinsky said the firm settled to avoid litigation.

'Our process meets or exceeds all legal and regulatory requirements,' Shivinsky said in a statement. 'In every instance, we provide immediate notice, ensure multiple layers of review, involve a medical director in the decision, give members an opportunity to provide additional information before we take any action, and follow the guidance of an independent third party review.'

Note that rescission is now against US federal law:

President Obama made rescission a central theme in his push for a healthcare overhaul. In September 2010, a ban on rescissions for unintentional application errors became one of the first pieces of the healthcare law to take effect.

GE Healthcare

On December 29, 2011, the Detroit Free Press reported (via USA Today):

Pharmaceutical giant GE Healthcare will pay $30 million to the U.S. Department of Justice to settle claims in a case filed by a Michigan salesman, alleging one of its companies marketed a diagnostic drug used in cardiology tests as one that could be diluted and stretched to more patients than intended.

Not surprisingly,

GE admitted no wrongdoing in the settlement.

This was despite the fact that the actions alleged may have harmed patients as well as defrauding the government:

For patients, the diluted product resulted in more false positives during cardiology tests and exposed them to additional and unnecessary testing....

We have posted previously about some previous questionable behavior by GE in the health care sphere.
Actavis

On January 3, 2012, Bloomberg reported:

Two units of Actavis Group Hf will pay $84 million to settle a lawsuit over drug pricing, Texas officials said, less than half the amount an Austin jury said the company should pay.

The state accused Actavis Mid-Atlantic LLC and Actavis Elizabeth LLC, subsidiaries of the Iceland-based company’s U.S. division, of inflating billings to the Texas Medicaid program by falsely reporting drug prices. The state court jury in February ordered the units to pay the state $170 million.

The settlement resolves that litigation, Texas Attorney General Greg Abbott said today in a statement.

Note that Medicaid is a joint federal-state insurance program for the poor.

The company's statement had a familiar ring to it:

'Actavis denies any and all wrongdoing, and denies that it has any liability relating to the Texas judgment,' the company and the state said in the settlement agreement. The parties reached a settlement 'to avoid the delay, uncertainty, inconvenience and expense of continuing the litigation.'

Nothing to see here, just move along.

Denver Health Medical Center

On January 5, 2012, the Denver Post reported:

Denver Health Medical Center will pay $6.3 million to federal and state officials for overbilling Medicare and Medicaid, state and U.S. attorneys said.

After investigating a whistleblower's lawsuit, government officials said Denver Health was classifying patients with an "inpatient" status when it should have been listing them as 'outpatient' or under 'observation' status, which paid less under government rules.

Oops, missing from this story was the pro forma denial of blame, wrongdoing, misconduct by organizational leadership. However, the Denver Business Journal was able to add that:

Denver Health, in a statement, said it and the government agreed to the settlement to avoid 'protracted litigation' over the allegations. It did not admit guilt in agreeing to the settlement.

Of course, again despite having to pay millions, the organization asserted that it is fine and upstanding:

'Denver Health has, and will continue to, strive to ensure that its billing systems are accurate,' the hospital said in a statement, adding that the hospital has implemented a system to correct and improve billing accuracy.

Whoever wrote the statement seemed to overlook the implication that flowed from the need to "correct" the system.

CVS Caremark

On January 12, 2012, the Baltimore Sun reported:

The Federal Trade Commission announced that CVS Caremark Corp. agreed to pay $5 million to settle a complaint that it misinformed seniors about the price of certain Medicare Part D prescription drugs sold through CVS and Walgreens pharmacies.

The action by the company, according to the FTC, caused seniors and consumers with disabilities to pay significantly more for drugs. It also pushed them more quickly into the so-called 'doughnut hole,' in which drug costs aren’t covered by the federal program.

Despite its multimillion dollar payment, the company admitted no guilt, of course, and asserted its exemplary corporate citizenship:

CVS Caremark released a statement:

'During the course of this two year investigation, our company cooperated fully with the FTC and provided to the government millions of documents as well as access to numerous members of our management team who participated in voluntary interviews and depositions,' said Douglas A. Sgarro, Executive Vice President and Chief Legal Officer of CVS Caremark.

He also took comfort from the fact that there were not even more charges:

It is important to note that, at the conclusion of this comprehensive investigation, the FTC made no allegations of antitrust law violations or anti-competitive behavior associated with any of our business practices, products or service offerings.

Stryker Corp

On January 18, 2012, Bloomberg reported:

A Stryker Corp. (SYK) unit agreed to plead guilty and pay a $15 million fine while the medical-device maker was on trial on charges it marketed an unapproved mixture of products for strengthening human bone growth.

The unit, Stryker Biotech, and three Stryker sales representatives were on trial in federal court in Boston on a 13-count criminal indictment claiming conspiracy and wire fraud. The trial began Jan. 9 with jury selection.

Stryker Biotech agreed to plead to one misdemeanor count of misbranding a medical device, according to a letter dated yesterday from the U.S. Attorney’s Office in Boston and filed with the federal court.

This did involve an admission of guilt, but to what amounts to a financial violation when there were allegations that patients may have been harmed:

The U.S. had charged Stryker Biotech with misbranding and its sales force with conspiring to defraud surgeons into combining the company’s OP-1 and OP-1 Putty with the bone filler Calstrux. Some patients suffered adverse side effects and required more surgery, the U.S. said.

'That mixture was never studied clinically,' Assistant U.S. Attorney Susan Winkler told the jury in her opening statement on Jan. 12. 'They did not know if it worked. They did not know if it was safe, and they marketed it to doctors anyway.'

Interval Summary

We have presented eight cases in which  major US health care organizations settled cases involving allegations of financial gain under false pretenses. Nearly all involved US federal charges, and the others included alleged misbehavior that affected a federal program or that now would be illegal under federal law. All the cases were resolved with fines over $1 million. However, while these fines may seem big to most people, they were trivial compared to the revenues of the organizations. None of the settlements involved any penalties to actual people who authorized, directed, or implemented the misbehavior. No individuals at any of the involved organizations admitted any mistakes, much less wrong doing.

While the volume of such settlements indicates the prevalence of misbehavior by large health care organizations, it is not clear that their results, which amount to slaps on corporate wrists, have any deterrent effect.

In comparison, see what happens when little people obtain money from the government under false pretenses. I found a convenience sample of such cases reported in the last month through a Google search.

Vasquez

On January 9, the San Francisco Chronicle reported:

A Los Angeles woman who pleaded guilty to committing $6.2 million in Medicare fraud has been sentenced to 5 years in prison.

Federal Health and Human Services officials say 47-year-old Carolyn Ann Vasquez has also been ordered to pay $6.2 million in restitution.

Vasquez admitted to conspiring with others to use a series of fraudulent Los Angeles-area medical clinics to defraud the federal health care insurance program for people over age 65 and the disabled.

Between 2007 and 2008, Vasquez obtained a physician's personal information and Medicare provider number and used it to print prescription pads.

She then had a physician's assistant, David Garrison, write fraudulent prescriptions for pricey medical equipment.

Curtis

On January 7, 2012, the [Jacksonville] Florida Times-Union reported:

A federal judge sentenced the would-be owner of a Brunswick prosthetic business to three years and six months in prison for his organization and leadership of a scheme that defrauded Medicare of more than $250,000.

Also,

In addition to prison, Wood sentenced Curtis to repay $254,750.94 to Health and Human Services and serve three years’ probation. She dismissed eight other counts as part of his plea agreement.

In stark contrast to the stories above about cases of fraud involving large health care organizations:

Samuel Curtis III, who had submitted false claims from Preferred Prosthetics and Orthotics in Brunswick and Team Orthotics and Prosthetics of Houston, had pleaded guilty in July to conspiring to commit health care fraud.

Curtis, 38, apologized and asked U.S. District Judge Lisa Godbey Wood for leniency during his sentencing hearing Friday.

Popov

On January 12, 2012, the Sacramento Bee reported:

A Los Angeles physician who assumed the role as co-owner of a Sacramento medical clinic has been sentenced to federal prison for his participation in a Medicare fraud scam.

Alexander Popov, 47, was sentenced today by U.S. District Judge Morrison C.England Jr. to eight years and one month in prison for committing health care fraud and conspiring to commit health care fraud, according to a federal Department of Justice news release. He was found guilty by a jury in July.

In sentencing, Judge England found that Popov was responsible for more than a million dollars in fraudulent billings submitted to Medicare and more than $600,000 in payments made on false claims.

Evidence at trial showed that Popov gave false testimony and manufactured evidence at trial, amounting to an obstruction of justice, officials said.

Also,

Vardges Egiazarian previously pleaded guilty in the case and is serving 78 months in prison.

Applebaum

On January 20, 2012, Medscape reported:

A former Idaho psychiatrist was ordered to pay nearly $95,000 in a legal judgment this week, adding to a prison sentence of up to 5 years, which he received in November for obstruction and falsifying records relating to Medicaid fraud.

The judgment, obtained by the US Attorney's Office against Michael Applebaum, MD, of Nampa, Idaho, involved a civil lawsuit in which he was accused of submitting false Medicare and Medicaid claims for undocumented and ineligible services from 2004 through 2009.

Prosecutors claimed Dr. Applebaum failed to properly document services for approximately 502 claims, including falsifying service dates on 49 claims to make them appear eligible for reimbursement under Medicaid's rule of submitting claims within 12 months of the date of service.

Summary

As we noted above, if a large organization, such as a hospital system, pharmaceutical company, or health insurance company is accused of fraud against the government, the outcome is likely to be a large fine that is nonetheless small compared with the organization's revenue, no admission of guilt or responsibility, and no penalties for any individuals who authorized, directed or implemented the misbehavior. However, if an individual or small business is accused of such fraud, the results are likely to include fines sufficient to bankrupt either, admissions of guilt, and years of jail time.

Yet such actions by large organizations are likely to be more harmful to individuals and society than those of individuals or small businesses.

This seems like a glaring, stark example of unequal justice in health care. If an individual does something bad in a health care context, the punishment is likely to be severe and life altering. If an individual who is a leader of a large health care organization does something equally bad, he or she is likely to receive no punishment at all.

This is an example that ought to unite the left and the right, liberals and libertarians in outrage. Liberals are supposed to believe in the rights of the individual and economic justice. Libertarians are supposed to believe in economic freedom and the economic rights of the individual. In this example, the government and large corporations seem to have gotten together to let corporate leaders play by different rules than individuals. Corporate leaders seem to be above the law, the same law that can ruin individuals who violate it.

If we really want to reform health care, we need to make sure that its rules apply equally to all individuals, whether humble or rich, whether they are individual professionals of corporate CEOs. As long as the rich and powerful can play by different rules, we only fuel cynicism and anger. Down that road lies disaster.

A Few Additional Comments on the GE Radiation Debacle

Roy Poses beat me to posting about the General Electric CT over-irradiation debacle (GE: Don't Know Much About Radiation Safety, Don't Know Much About Physics).

I am going to add two points:

Point 1:

The National Research Council in its 2009 report on health IT warned that "current approaches to healthcare IT are insufficient", and one of the major caveats was that:

... greater emphasis should be placed on information technology that provides health care workers and patients with cognitive support, such as assistance in decision-making and problem-solving.

In fact the lack of cognitive support for clinicians was one of the report's major themes.

"Cognitive support" by definition means producing devices (whether physical or virtual) that are intended for busy clinical settings where situations often resemble a madhouse - not calm, solitary office environments (borrowing from Joan Ash's findings on CPOE flaws):

"Many information systems simply don't reflect the health care professional's hectic work environment with its all too frequent interruptions from phone calls, pages, colleagues and patients. Instead these are designed for people who work in calm and solitary environments. This design disconnect is the source of both types of silent errors …Some patient care information systems require data entry that is so elaborate that time spent recording patient data is significantly greater than it was with its paper predecessors," the authors wrote. "What is worse, on several occasions during our studies, overly structured data entry led to a loss of cognitive focus by the clinician."

It does not mean, as reported on July 31, 2010 in the New York Times, that designers and vendors of these medical devices should take the stance of blaming the user:

A GE spokesman, Arvind Gopalratnam, said the way scanners were programmed was “determined by the user and not the manufacturer.” GE, he added, has no record of Glendale seeking its help setting up the new procedure in 2009.

... GE says the hospitals should have known how to safely use the automatic feature. Besides, GE said, the feature had “limited utility” for a perfusion scan because the test targets one specific area of the brain, rather than body parts of varying thickness. In addition, experts say high-clarity images are not needed to track blood flow in the brain.

GE further faulted hospital technologists for failing to notice dosing levels on their treatment screens.

But representatives of both hospitals said GE trainers never fully explained the automatic feature.

Imagine the reaction if Boeing blamed pilots for collisions if those pilots, busy with other matters, were only alerted to an impending collision via a range reading on their cluttered instrument panel - rather than a LOUD AUDIBLE ALARM - such as WARNING, WARNING, COLLISION IMMINENT.

Point 2:

What's really missing here was attention to cognitive support for busy clinicians. This, of course, requires proper senior management - senior management with the appropriate expertise.

Proper senior management then controls talent management down the chain of an organization. If the leaders "don't know nothing 'bout trigonometry", they will be less likely to put mathematicians in appropriate leadership roles.

If management doesn't understand Medical Informatics, they will be less likely to put informaticists into leadership roles as well. One major focus of Medical Informatics is cognitive support of busy clinicians in their all too real-world environments.

Why might the latter point be relevant at GE?

In 1999 after working for a competitor of GE, Comdisco Healthcare Group, who among other business aspects reconditioned and resold capital equipment such as CT scanners, I wrote this in an essay on "what medical informatics is not":

... I've noted a number of large vendors and even national medical organizations whose so-called "Medical Informatics Directors" had neither clinical backgrounds nor training in medical informatics (nor in information science of any kind). MIS managers, social workers, and clinicians with no more experience than some tinkering with a home Macintosh can be found as "Directors of Medical Informatics" in the (unfortunately) unregulated healthcare IT industry.

Sometimes the term is used as a sales slogan. General Electric displayed a huge banner over their booth proclaiming themselves "the world leader in Radiology Informatics" at the 1999 Radiological Society of North America (RSNA) conference in Chicago. Unfortunately, nobody present, including sales, management, and engineering representatives, could explain to me what that term meant. They actually said they did not know. I had only identified myself as a physician at that point, not as a medical informatics professional, and expressed incredulity on nobody being able to explain the banner to me. Under pressure, one GE engineer offered the statement "I think it has something to do with computers attached to our x-ray machines."

It's now 2010. It seems GE still may not know what Medical Informatics is.

Handing busy clinical end users a revolver with a single bullet in the chamber, and asking them to play Russian Roulette under busy circumstances with a warning to "check the chamber carefully each time before you pull the trigger", is simply unacceptable for computerized medical device design.

-- SS

GE: Don't Know Much About Radiation Safety, Don't Know Much About Physics

Don't know much about history

Don't know much biology
Don't know much about a science book
Don't know much about the french I took.
(Wonderful World, sung by Sam Cook)

This is becoming the theme song for executives of health care corporations.  We have posted about a series of cases in which major health care corporations suddenly seemed unable to carry out their core business functions, a phenomenon I am going to start calling "core business incompetence."  Some recent examples:
-  Baxter International apparently failed to check the purity of heparin it bought from a foreign supplier; the contaminated heparin resulted in approximately 81 deaths. (See post here.)
-  A major Genzyme manufacturing facility had multiple quality problems, resulting in the production of a very expensive, but contaminated biologic medication. (See post here.)
-  Three Johnson and Johnson manufacturing facilities had multiple quality problems, resulting in the production of contaminated batches of over-the-counter medications for children. (See post here.)
-  Aetna made mathematical errors in computing the rates it proposed charging; WellPoint made computer errors that exposed sensitive policy-holder information.  (See blog post here.)

Manufacturing pure, unadulterated medicines is a core function of a drug company.  Correctly calculating policy-costs and correctly handling patient data are core functions of health insurance companies.  But in the above cases, three large pharmaceutical companies and two large insurance companies could not perform these core functions competently.

Radiation Sickness from CT Scans
In the last few days, more details of what appears to be another example of core incompetency afflicting a major health care organization has surfaced.  The details were reported by Walt Bogdanich in the New York Times. Here is the summary:

When Alain Reyes’s hair suddenly fell out in a freakish band circling his head, he was not the only one worried about his health. His co-workers at a shipping company avoided him, and his boss sent him home, fearing he had a contagious disease.

Only later would Mr. Reyes learn what had caused him so much physical and emotional grief: he had received a radiation overdose during a test for a stroke at a hospital in Glendale, Calif.

Other patients getting the procedure, called a CT brain perfusion scan, were being overdosed, too — 37 of them just up the freeway at Providence Saint Joseph Medical Center in Burbank, 269 more at the renowned Cedars-Sinai Medical Center in Los Angeles and dozens more at a hospital in Huntsville, Ala.

The overdoses, which began to emerge late last summer, set off an investigation by the Food and Drug Administration into why patients tested with this complex yet lightly regulated technology were bombarded with excessive radiation. After 10 months, the agency has yet to provide a final report on what it found.

But an examination by The New York Times has found that radiation overdoses were larger and more widespread than previously known, that patients have reported symptoms considerably more serious than losing their hair, and that experts say they may face long-term risks of cancer and brain damage.

So not to mince words, in this sad case, many patients seem to have been subject to radiation poisoning from a diagnostic x-ray procedure (not from radiation therapy for cancer.)  Most people (and physicians) may have not previously thought that radiation poisoning was a possible harm from a single diagnostic CT scan.

A Design Failure?

Moreover, it appears that the radiation poisoning did not result from some freak accidents or malfunction:

The review also offers insight into the way many of the overdoses occurred. While in some cases technicians did not know how to properly administer the test, interviews with hospital officials and a review of public records raise new questions about the role of manufacturers, including how well they design their software and equipment and train those who use them.

Also,

None of the overdoses can be attributed to malfunctions of the CT scanners, government officials say.

At Glendale Adventist Medical Center, where Mr. Reyes and nine others were overdosed, employees told state investigators that they consulted with GE last year when instituting a new procedure to get quicker images of blood flow, state records show. But employees still made mistakes.

As a result, hospital officials said, a feature that technicians thought would lower radiation levels actually raised them. Cedars-Sinai gave a similar explanation.

'There was a lot of trust in the manufacturers and trust in the technology that this type of equipment in this day and age would not allow you to get more radiation than was absolutely necessary,' said Robert Marchuck, the Glendale hospital’s vice president of ancillary services.

A GE spokesman, Arvind Gopalratnam, said the way scanners were programmed was 'determined by the user and not the manufacturer.' GE, he added, has no record of Glendale seeking its help setting up the new procedure in 2009.

Most of the known overdoses, including the biggest, occurred on scanners made by GE Healthcare. At two hospitals that use Toshiba scanners — Los Angeles County-U.S.C. and South Lake in Florida — officials said the manufacturer suggested machine settings that ultimately produced too much radiation. Representatives of Toshiba agreed to be interviewed in their California office but abruptly canceled.

In particular,

To this day, no one at Cedars-Sinai knows who programmed the scanners that delivered the overdoses, officials there say. But in written statements to The Times, hospital officials said they had figured out how they might have occurred.

Normally, the more radiation a CT scan uses, the better the image. But amid concerns that patients are getting more radiation than necessary, the medical community has embraced the idea of using only enough to obtain an image sufficient for diagnosis.

To do that, GE offers a feature on its CT scanner that can automatically adjust the dose according to a patient’s size and body part. It is, a GE manual says, 'a technical innovation that significantly reduces radiation dose.'

At Cedars-Sinai and Glendale Adventist, technicians used the automatic feature — rather than a fixed, predetermined radiation level — for their brain perfusion scans.

But a surprise awaited them: when used with certain machine settings that govern image clarity, the automatic feature did not reduce the dose — it raised it.

As a result, patients at Cedars-Sinai received up to eight times as much radiation as necessary, while the 10 overradiated at Glendale received four times as much, state records show.

GE says the hospitals should have known how to safely use the automatic feature. Besides, GE said, the feature had 'limited utility' for a perfusion scan because the test targets one specific area of the brain, rather than body parts of varying thickness. In addition, experts say high-clarity images are not needed to track blood flow in the brain.

GE further faulted hospital technologists for failing to notice dosing levels on their treatment screens.

But representatives of both hospitals said GE trainers never fully explained the automatic feature.

In a statement, Cedars-Sinai said that during multiple training visits, GE never mentioned the 'counterintuitive' nature of a feature that promises to lower radiation but ends up raising it. The hospital also said user manuals never pointed out that the automatic feature was of limited value for perfusion scans.

A better-designed CT scanner, safety experts say, might have prevented the overdoses by alerting operators, or simply shutting down, when doses reached dangerous levels.

Summary: Core Incompetence
To summarize, GE diagnostic CT scan machines apparently were designed so that they could deliver so much radiation that their use could cause radiation sickness. The machines had no built in safeguards to limit the dose of radiation. Users, that is, X-ray technicians, could program the machine so as to deliver dangerous radiation doses, but GE did not warn them that this was the case, nor provide a machine feature that would give a real-time warning of incipient overdose.

Thus it appears that GE, which has been described as "the world’s biggest maker of health care imaging and information technology systems," failed in its core function of designing and manufacturing safe diagnostic x-ray machines. (Presumably the same might be said of Toshiba, but the NY Times report does not include so much detail about problems with its machines.)

A straightforward explanation of the magnitude of the core incompetence was provided by one of the patients who got radiation sickness:

To Mr. Heuser, it is unconscionable that equipment able to deliver such high radiation doses lacks stronger safety features.

'When you are in a car and it backs up, it goes beep, beep, beep,' he said. 'If you fill the washing machine up too much, it won’t work. There is no red light that says you are overradiating.'

It really seems like we are seeing an epidemic of core incompetence by major US health care corporations.

I can only speculate about why this occurring. One explanation is that the organizations may be lead by people who do not understand the health care context, and do not understand the scientific, engineering, and technical issues involved with core competence. Many health care corporations have come to be lead by people with no experience or background in relevant areas.

For example, the current, and often acclaimed CEO of GE is Jeffrey Immelt, who "earned a B.A. degree in applied mathematics from Dartmouth College in 1978 and an M.B.A. from Harvard University in 1982." The leader of GE Healthcare is John Dineen, who "is a graduate of the University of Vermont where he earned Bachelor's degrees in biology/genetics and computer science," and "joined GE in 1986 as a telecommunications engineer."

Another, even more speculative explanation is that many major US and global health care organizations seem to have been infected with the virus of putting short-term financial results ahead of everything else, leading to cutting of costs and particularly human expertise in the areas most core to the organizations' functions, and pushing for hurried results even at the expense of clear thinking, carefully engineering, and consideration of the effects on patients and other humans of the resulting mistakes.

Hopefully, further investigation will reveal more about what went wrong in this case. Meanwhile, I say again, again, again,...

As long as "imperial CEOs" can continue to get extremely rich while presiding over incompetence and stupidity, if not worse), we can expect the foolishness to continue. Meanwhile, the foolishness drives up costs and drives down quality of health care for the poor suffering patients, let alone the physicians and other health care professionals who must deal with it.

To really reform health care, we need to provide incentives for competent, honest leadership, and make that leadership accountable for its shortcomings.

Postscript - Why the Rush to Aggressive Treatment?

The NY Times article described the rush to get one of the afflicted patients to the CT scan:

on the morning of July 4, when a 52-year-old executive producer of films, H. Michael Heuser, arrived in the emergency department with stroke symptoms.

A 'code brain' was immediately called, signaling a life-or-death situation. A blood clot in the brain can be dissolved with medicine, but doctors must do it within several hours, before brain cells die from a lack of oxygen. So Mr. Heuser was rushed into a room with several CT scanners, where he underwent one brain perfusion study and at least one more later. A CT perfusion scan, which lasts about 45 seconds, can identify a stroke through a series of blood flow images.

Mr. Heuser did have a stroke, from which he would recover. But other parts of his body inexplicably began to break down.

However, there is no clear evidence that such a rapid and drastic approach is really that good for patients. A recently updated Cochrane review concluded: "In patients with acute ischaemic stroke, immediate anticoagulant therapy is not associated with net short or long-term benefit. Treatment with anticoagulants reduced recurrent stroke, deep vein thrombosis and pulmonary embolism, but increased bleeding risk. The data do not support the routine use of any the currently available anticoagulants in acute ischaemic stroke." However, many physicians seem to advocate the drastic approach based on some controlled trials that showed at best small improvements in average neurological function for patients receiving rapid anti-coagulation (and which were done before anyone thought about radiation sickness as a possible harm of the approach.) Once again, an aggressive, technological, expensive approach, possibly advocated by people who stood to gain financially from it, may not be as advantageous as it appears.

Lessons Unlearned: Health IT Failure, Act 2

The following appeared on the HISTalk site on 8/14/2009 from a writer with the screen name UCSFWatch:

From UCSFWatch: “Re: UCSF CIO’s e-mail. The GE Centricity Enterprise project is in full stop mode.” The attached and unverified e-mail from CIO Larry Lotenero says this: “The medical center’s Senior Management Group has engaged Kurt Salmon Associates (KSA) to assist us with a review of our IT clinical strategy. We are doing the review because we are dissatisfied with our progress to implement clinical applications to support the care of our patients. KSA will arrange interviews with many of you to capture your insights for the strategy planning. They will be on-site to begin their interviews on August 18. If KSA contacts you, I ask that you be as flexible as possible with your schedule to accommodate this process. We expect to receive a final report before November. For now, all activities associated with developing the GE clinical system should immediately be put on hold. Despite this action, we remain fully focused on our goal to complement our excellent clinical care providers with equally excellent clinical applications as soon as possible.”

If true (as it likely is), I find this remarkable.

I would have to refer to it as "UCSF Healthcare IT Failure, Act 2" for reasons just below.

I find it remarkable that this resource- and money-wasting scenario (with possible adverse patient care repercussions) can occur:

• In a state that's in a severe economic crisis,

• At an organization that failed severely in a HIT and administrative IT merger just ten years ago (in the failed, late 1990's attempted merger between UCSF and Stanford's medical centers, see the 2000 stories "UCSF/Stanford: Marriage was rough; divorce is expensive" here and "A thousand MIS personnel cannot merge two healthcare systems" here),

• With an EHR product, Centricity, that is the descendant of Logician that others have implemented successfully (including myself, speaking from experience),

• With GE, a major global high technology vendor, presiding over this new failure at a major academic medical center,
  

• With ample preventive material available in books, journals on the web about such failures (e.g., at the many pages and links here and here, as just a few examples).
  

This last point raises additional questions:

• Do IT managers at UCSF and GE actually read the HIT literature and the web, I wonder? Have they ever done a Google search on "healthcare IT difficulties" or "healthcare IT failure", or related concepts?
  

• Do they think the materials found via such searches frivolous, useless, or not credible?
  

Finally, it is quite remarkable that the best UCSF can do is hire yet another expensive management consulting firm to try to remediate this failure. What are UCSF IT personnel paid to do, exactly?

Perhaps AMIA, AHRQ, HHS and others in the administration need to focus less on new research on figuring why these situations occur, and devote resources to ensuring modern knowledge of HIT failure scenarios already extant is leveraged.

If not, we're likely (as I fear) to have a lot of UCSF Act 2's in the next few years, as organizations attempt to implement HIT by 2014 so as to not be penalized by HIT provisions in the ARRA act.

Perhaps (again, if the HISTalk note is true), we need to bring back the likes of "Neutron Jack" (Jack Welch, well known for laying off less than stellar divisions at GE), and perhaps the Governator needs to "terminate" the roles of the leadership of this project.

Gov. Schwarzenegger had a way with those
who fiddled around destructively with computers...

See other disappointing stories about events at UCSF on this blog at this link.

-- SS

Smoked Out: Funding Lung Cancer Screening Research with Tobacco Money

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

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

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

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

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

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

But you ain't seen nothing yet.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

You just can't make this stuff up.

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

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

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

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

Also,

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

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

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

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

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

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

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

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

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

References

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

Cancer Screening, CT Scans, and Patent Applications

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.

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.

Consent Decree Stops Shipping Some "Transformational Medical Technologies"

From the Deseret News, a report that the US Food and Drug Administration (FDA) has obtained a consent decree to force GE OEC Medical Systems, a subsidary of GE Healthcare, which is in turn a subsidiary of General Electric, to stop shipping fluoroscopic X-ray and navigation systems used in orthopedic, cardiac, vascular and urologic surgical procedures. GE Healthcare boasts of providing "transformational medical technologies and services that are shaping a new age of patient care."

Here's the story, edited and re-sequenced a bit,

General Electric bought OEC Medical Systems in 1999. It is part of the $15 billion GE Healthcare division with some 70 facilities worldwide. Since that time, OEC revenue more than doubled to some $500 million annually. Profit margins have soared to 50 percent, meaning the company clears about $250 million a year. The company has a dominant 70 percent market share.

The FDA issued GE OEC Medical Systems, 384 Wright Brothers Drive, a warning letter in March 2005 after an audit revealed serious quality control lapses in manufacturing, packing, storage and installation of its equipment.

For example, the inspection showed that test technicians for more than a year photocopied results from one device to another rather than create new documents for each device. It also revealed failure to timely report equipment malfunctions 'likely to cause or contribute to a death or injury if the malfunction were to recur.'

A follow-up audit last August showed the company still wasn't in compliance with FDA quality-assurance requirements.

Upper management had ignored internal pleas for money and personnel to correct the deficiencies identified in the FDA audits, sources told the Deseret Morning News.
GE OEC Medical Systems ceased shipping its fluoroscopic X-ray and navigation systems last September after audits revealed numerous violations of federal quality assurance regulations. About 30 employees went on furlough.

On Friday, the FDA announced a consent decree with the company, a subsidiary of global giant General Electric, prohibiting it from making and distributing the equipment until it complies with federal law. GE OEC Medical Systems is part of the GE Healthcare division. The decree, which serves as a permanent injunction, was filed in U.S. District Court for Utah.

In a statement, Pete McCabe, president and CEO, Surgery, GE OEC Medical Systems, said the company is committed to making safe products and following FDA rules.

'Patient safety and quality continue to be our top priorities,' he said in a company statement.

This story reminds us of some important points. The profit margins for the manufacture of medical devices are huge. Large corporations not usually identified as health care corporations, like General Electric, play important roles in the huge and complex health care system, such as manufacturing medical devices. Such corporations are not immune to the problems that now plague "pure" health care organizations. In the current case, there were allegations of mis-handled safety inspections, and "upper management's" unwillingness to deal with safety problems in one of the company's new "transformational technologies." Finally, although patient safety problems are most often attributed to errors by health care professionals, they can also result from mismanagement within health care organizations.