Princess Health and Stryker Subsidiary Pleads Guilty to Selling Adulterated Devices, Former CEO of Subsidiary Pleads Guilty to Fraud, Stryker's Track Record Goes Unremarked. Princessiccia

Princess Health and Stryker Subsidiary Pleads Guilty to Selling Adulterated Devices, Former CEO of Subsidiary Pleads Guilty to Fraud, Stryker's Track Record Goes Unremarked. Princessiccia

adulterated devices anechoic effect crime fraud impunity legal settlements medical devices Stryker

Gusty 13:42 Add Comment

The US Thanksgiving Day parade is over, so it must be time for the march of legal settlements to begin again. Our next example was best described by Bloomberg and by NJcom, but brief articles from the Associated Press, Reuters, and the Wall Street Journal have also appeared.

The Basic Facts

The Bloomberg lede was,

Stryker Corp. OtisMed unit pleaded guilty to selling devices used in knee-replacement surgeries in September 2009 without regulatory approval and will pay more than $80 million to resolve the case.

The conduct in question was,

The company admitted it never obtained U.S. Food and Drug Administration approval to sell 18,000 custom-built devices used by surgeons from 2006 to 2009 to make accurate bone cuts to implant prosthetic knees. OtisMed applied for FDA approval in October 2008, and the agency said 13 months later the company hadn�t shown it was safe and effective. [OtisMed CEO Charlie] Chi then shipped 218 devices to surgeons, overruling his advisers and board.

Furthermore, in this case, there was some information about who actually did what,

After a conference call with OtisMed directors on Sept. 9, 2009, Chi talked to two employees about ways to hide the shipments from the FDA, including taking them to an off-site shipping location, using Chi�s personal Federal Express account, and backdating shipping documents, court records show.

The NJ.com report clarified to what charges the guilty pleas referred,

Charlie Chi, 45, pleaded guilty to three misdemeanor counts of fraud linked to the September 2009 shipment of 218 OtisMed devices to surgeons throughout the U.S., including 16 in New Jersey.

Also,

OtisMed, which was acquired by Stryker Corp., pleaded guilty to a felony charge of distributing adulterated medical devices into interstate commerce.... 

So, a company acquired by large medical device manufacturer Stryker admitted and pleaded guilty to charges that it fraudulantly marketed an unapproved device, and that this marketing was lead and facilitated by the company's CEO.  The CEO pleaded guilty to misdemeanor fraud charges.

The Penalties

Per Bloomberg,

OtisMed will pay a fine of $34.4 million and forfeit $5.16 million in a criminal case, while paying a civil fine of $41.2 million. The company pleaded guilty today in federal court in Newark, New Jersey, where former Chief Executive Officer Charlie Chi also pleaded guilty.

Chi has not yet been sentenced, but according to NJ.com,

Chi, of San Francisco, faces up to three years in prison when he�s sentenced on March 18, 2015.

Bloomberg noted that,

The $80 million payment is almost three times the total revenue that OtisMed got for all of the knees the company sold, according to Fishman.

However, the amount could also be compared to the approximate annual revenue of Stryker Corp, which was most recently about $8 billion per Google Finance, or its net income, about $1 billion.

Furthermore,

OtisMed was barred from Medicare, Medicaid and all other federal health-care programs for 20 years. Stryker, based in Kalamazoo, Michigan, wasn�t barred.

This case was unusual in that a health care corporate CEO was actually charged and pleaded guilty to crimes connected to illegal marketing practices, and in that his company not only admitted wrongdoing and pleaded guilty, but also agreed to disbarment from federal programs.  However, by the time the case was thus decided, the CEO was no longer CEO, his company had been acquired by a larger health care corporation, and that corporation, while letting its new subsidiary agree to a fine and disbarment, was not itself disbarred from anything. 

Stryker's Track Record 

The Bloomberg noted that Stryker did not have unblemished track record,

In 2007, New Jersey�s U.S. attorney at the time, Chris Christie, reached an agreement with four makers of hip- and knee-implants that paid $310 million to settle U.S. claims they paid kickbacks to surgeons who used their products. Stryker, a fifth company, received a non-prosecution deal. Christie, a possible Republican presidential candidate in 2016, is now governor.

In fact, that year, we posted (here, here, here, and here) about the payments, often huge, that five manufacturers of prosthetic joints (Biomet, DePuy Orthopaedics (a unit of Johnson & Johnson), Stryker Orthopedics,a unit of Stryker Inc, Zimmer Holdings, and Smith & Nephew) revealed they made to orthopedic surgeons and various academic and other organizations. We also noted that some of the leadership of the major orthopedic societies have received substantial amounts from these companies, as have the societies themselves.

However, there is much more to the Stryker track record,

In 2013, we noted that Stryker paid $13.2 million to settle charges that it bribed doctors in various countries to use its devices, violating the US Foreign Corrupt Practices Act (FCPA) (look here).

In 2012, we noted that Stryker paid a $15 million fine after pleading guilty to a federal count of misbranding a medical device. Government prosecutors alleged the company conspired to defraud surgeons into combining two of its products, contrary to their labeled usage, and possibly harming patients (look here).

In 2010, we noted that Stryker paid $1.35 million to settle charges that it marketed bone growth products without FDA approval (look here).

In 2009, we noted that two Stryker sales representatives pleaded guilty to charges they promoted off-label use of Stryker bone growth products although they knew such use could endanger patients (look here).  

So the larger corporation that paid fines that appeared large, but were actually small given its size, and that let its subsidiary and its subsidiary's former CEO otherwise take the raps, had a long track record of similarly questionable behavior.  That track record did not apparently inform the resolution of the current case.


Summary

So here we go again. A large medical device company resolved charges of wrongdoing by paying a fine that appears large to the common person, but in fact was small compared to its revenue.  The case was unusual in that the company did admit wrongdoing, but in a way that seemed to reflect the blame onto one of its subsidiaries.  The case was further unusual in that a CEO was charged and pleaded guilty, but it was not the CEO of the large corporation, but the former CEO of the acquired company.  The case was yet further unusual in that a company was disbarred from transactions with the federal government, but the company was just the subsidiary of the larger company, which otherwise could continue business as usual. 

Thus while the penalties meted out in this case seemed more severe than usual, on examination they left the big parent corporation relatively unscathed.  No one still in management at that corporation, including anyone involved in the acquisition of the wayward subsidiary, apparently will suffer any negative consequences.  Furthermore, that larger corporation turns out to have a substantial track record of previous misbehavior.  Yet that did not apparently affect the outcome of this case, and little of this track record was even reflected in the reporting of the current case.

While we have often - some might say ad infinitum - discussed the march of legal settlements by large health care organizations, and how these settlements seem to impose relatively small penalties on the corporations, and leave their hired managers untouched, these settlements seem to produce few echoes.  Like many other examples of unpleasantness that might reflect badly on the leaders of large health care organizations, even those who may have personally profited from the unpleasantness, they remain largely anechoic.  So we would urge the reporters who cover the next settlements by big health care organizations at least look to see if the organizations had been involved in similar settlements in the past

Finally, as we have said all to often,...   The failure of the current limp legal efforts against such corruption is evident by how many corporations have become ethical repeat offenders.  Pervasive bad behavior by large health care organizations has got to be a major cause of our ongoing health care dysfunction.  So, to really deter bad behavior, those who authorized, directed or implemented bad behavior must be held accountable. As long as they are not, expect the bad behavior to continue.

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

conflicts of interest medical devices orthopedic surgeons

Gusty 13:49 Add Comment

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 Hacking an ICD. Princessiccia

Princess Health and Hacking an ICD. Princessiccia

ICD ill-informed management medical devices Medtronic

Gusty 07:35 Add Comment

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.

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

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

cancer conflicts of interest CT scans General Electric medical devices screening

Gusty 11:19 Add Comment

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.

Princess Health and A SLAPP Against Clinical Research?. Princessiccia

Princess Health and A SLAPP Against Clinical Research?. Princessiccia

free speech intimidation medical devices

Gusty 14:11 Add Comment

Posts on the Wall Street Journal Health Blog, the Clinical Psychology and Psychiatry Blog, and by Dr Aubrey Blumsohn on the Scientific Misconduct Blog all picked up on a brief story in the Harvard Crimson about a lawsuit apparently claiming that a clinical research article, and a randomized controlled trial no less, was defamatory. Here is the gist from that news article,

Harvard Medical School professor Douglas P. Kiel is facing a lawsuit because of an article he published in the July 2007 issue of the Journal of American Medicine (JAMA).

In the study, Kiel, a gerontologist, said that hip protectors are not effective in preventing injuries among elderly patients, a claim challenged by HipSaver, a popular hip protector manufacturer, in a suit filed in Norfolk Superior Court on Feb. 15.

HipSaver�s president, Edward L. Goodwin, said in an interview that it was scientifically inaccurate for the conclusions of Kiel�s study to be applied to hip protectors in general.

Robert L. Hernandez, who is representing HipSaver, described Kiel�s article as 'disparaging' and 'grandiose.'

Actually, as quoted by Dr Blumsohn, the JAMA article's conclusions were framed in the typically measured terms of clinical research reports.

In summary, this large multicenter clinical trial failed to demonstrate a protective effect of a hip protector on hip fracture incidence in nursing home residents despite high adherence, confirming the growing body of evidence that hip protectors are not effective in nursing home populations.

These results add to the increasing body of evidence that hip protectors, as currently designed, are not effective for preventing hip fracture among nursing home residents.

[See Kiel DP, Magaziner J, Zimmerman S et al. Efficacy of a hip protector to prevent hip fracture in nursing home residents: the HIP PRO randomized controlled trial. JAMA. 2007; 298: 413-422. Link here.]

Of course, if these conclusions were libelous, than practically any scientific article could be considered libelous.

Equally obviously, HipSaver leadership have a perfect right to criticize the Kiel article. But to sue the authors because the company disagrees with their conclusions could have a chilling effect on science. This lawsuit seems to be a deliberate effort to intimidate clinical scientists who dared to collect and publish data which suggesting that commercial products may not be as wonderful as their marketers claim.

If clinical scientists start fearing to publish such conclusions, then we can throw the whole of science based medicine out. This, of course, would be a catastrophe.

Furthermore, this lawsuit can be construed as an attack on basic human rights in the US context. In this context, it appears to be a SLAPP, that is, Selective Litigation Against Public Participation. This term was coined to describe lawsuits designed to intimidate people from speaking out about issues of public interest (but in a way that might threaten vested interests.) For more information about SLAPPs, see the SLAPP Resource Center. Also see this article from the First Amendment Center.

Most US states, including Massachusetts, have laws that allow SLAPPs to be countered. For example, in Massachusetts, the law provides (see the SLAPP Resource Center), ]

Any written or oral statement made to, or in connection with, a governmental proceeding is protected under the statute. In addition, any statement that is reasonably likely to encourage review of an issue by the government or enlist public participation is protected under the statute. Other important provisions of the statute include: (1) a special motion to dismiss; (2) an expedited review of the special motion to dismiss; (3) the government may defend or support the defendant in the special motion to dismiss; (4) all discovery is stayed upon the filing of the special motion to dismiss; (5) the burden shifts to the plaintiff to prove the statements were not protected by the statute; and (6) costs and reasonable attorneys� fees shall be awarded to a victim prevailing on the motion to dismiss.

I don't think it is too much of a stretch to apply the SLAPP concept to a lawsuit aimed at the free discussion of the effectiveness of treatments in health care, given that the government indirectly or directly pays for many of these treatments, and that determining the effectiveness of treatments is clearly a public health policy issue.

I fervently hope HipSavers withdraws this ill-conceived lawsuit. If the company persists, I fervently hoped its attempted SLAPP gets slapped down.

Here is another sorry example of how health care, particularly clinical research, is under seige by those with vested interests and private agendas.

Princess Health and Stories About Device Manufacturers' Payments to Orthopedic Surgeons Resurface. Princessiccia

Princess Health and Stories About Device Manufacturers' Payments to Orthopedic Surgeons Resurface. Princessiccia

conflicts of interest medical devices orthopedic surgeons

Gusty 13:48 Add Comment

Late last year, we posted (here, here, and here) about the payments, often huge, that five manufacturers of prosthetic joints (Biomet, DePuy Orthopaedics (a unit of Johnson & Johnson), Stryker Orthopedics,a unit of Stryker Inc, Zimmer Holdings, and Smith & Nephew) revealed they made to orthopedic surgeons and various academic and other organizations. The lists are here: Biomet, DePuy, Smith & Nephew, Stryker, and Zimmer. We also noted that some of the leadership of the major orthopedic societies have received substantial amounts from these companies, as have the societies themselves.

Despite the obvious potential for these payments to influence practice, teaching, and research, the issue received almost no attention after the initial media reports. Last week, however, it created a few more ripples. As reported by Bloomberg News, via the Washington Post,

Four makers of artificial hips and knees paid doctors more than $800 million in royalties and fees in four years to influence their choice of implants, a U.S. investigator told Congress.

The unidentified companies control about three-quarters of the $9.4 billion worldwide market for hips and knees, said Gregory E. Demske, an assistant inspector general at the Health and Human Services Department, at a hearing yesterday of the Senate Special Committee on Aging.

'Illegitimate' payments, the extent of which is unknown, influence orthopedic surgeons' medical judgment and are so common that it will be difficult to eliminate the practice, Demske and other witnesses said. The fees have enriched doctors and distorted the market by bolstering sales of lower-quality devices, they said.

'Industry and physicians are equally culpable,' said Sen. Herb Kohl (D-Wis.), chairman of the panel. 'Some physicians make it known to the companies that they will be loyal to the highest bidder. Where does the patient's well-being fit into the equation?'

Even an executive at one of the device companies admitted problems with the payments.

It's clear the device companies went too far, said Chad Phipps, Zimmer's general counsel.

'In hindsight it now appears that as the industry expanded to meet patient needs, the use of consultants may have been excessive at times,' Phipps told the committee.

In addition, a Minneapolis Star-Tribune story referred to

Wine-tasting outings to California's Napa Valley. Ski trips to Colorado. Tickets to sporting events. Gourmet meals at swanky restaurants. Forays to 'adult entertainment' clubs. Fat checks for what some see as questionable work.

And a Wall Street Journal story gave this example

In some cases, a company sales representative would spend one or two hours in an operating room watching a surgeon implant his company's device. The company would then pay the doctor for eight to 10 hours of 'training' services, according to findings that government investigators shared with the committee.

Maybe I shouldn't be amazed that this story has provoked so little response, much less outrage. Even though some academic orthopedists were getting literally millions of dollars a year (see this post), very few seem worried that such fabulous payments might have had some influence on their clinical decisions, on what they taught their students or colleagues, or on their research.

As noted before, some people are concerned by how physicians may be influenced by gifts of pens, coffee mugs, and pizza lunches. If we should be concerned about coffee mugs, how much more should we be concerned by multi-million dollar royalties or consulting payments?

But of course, it's easier to forbid coffee mugs and pizzas for medical students and house-staff than making the chair of orthopedics choose between his job and his multi-million dollar royalties.