Astroturf Grows in Britain

This is just in case anyone thought this was only an American pheonomenon. As reported by the Independent.

The rising tide of protest over the refusal by the NHS to provide expensive drugs for cancer and other conditions is being funded by the pharmaceutical industry, an investigation by The Independent has revealed.

Patient groups that have been among the most vocal in spearheading attacks on the National Institute for Clinical Excellence (Nice) over decisions to restrict access to drugs on the NHS depend for up to half of their income on drug companies, but details are often undisclosed.

Protests have been launched by charities including the National Kidney Federation, the Arthritis and Musculoskeletal Alliance, the National Rheumatoid Arthritis Society, Beating Bowel Cancer, the Royal National Institute for the Blind and the Alzheimer's Society. All of these charities received sums of up to six figures from drug companies in 2007.

The extent of the drug companies' support for the smaller charities has led to criticisms that supposedly grassroots patient organisations are puppets of the pharmaceutical industry, being used to bludgeon Nice into making the drugs available on the health service.

Yet none of the charities named has criticised the high prices charged by the pharmaceutical companies for their products in their recent campaigns.

The National Kidney Federation (NKF) accused Nice of taking a "barbaric, damaging and unacceptable" decision when it turned down four kidney cancer drugs for NHS use this year and pledged to campaign against the decision. It did not criticise the cost of the drugs, at more than £3,000 for a 30-tablet pack. Half the NKF's £300,000 budget comes from the pharmaceutical and renal industries.

The Arthritis and Musculoskeletal Alliance (Arma) organised a protest letter from 10 professors of rheumatology, published in The Sunday Times last month, over a recent Nice decision to restrict access to arthritis drugs. The letter made no mention of the cost of the drugs but Ros Meek, chief executive, admitted that "half, or more" of the charity's £147,000 income came from the drug industry.

The National Rheumatoid Arthritis Society described the same Nice decision as "another nail in the coffin" for arthritis treatment and launched an appeal against it this week, with Arma and three drug companies. The society received 49 per cent of its £300,000 budget from the pharmaceutical industry in 2005-06, reducing to 26 per cent of its £472,000 budget in 2006-07.

We have heard physicians and leaders of not-for-profit organizations funded by pharmaceutical companies and other commercial health care organizations protest again and again that their activities and decisions are uninfluenced by the source of their money. For example, we recently posted about the President of the US American College of Cardiology who revealed that this medical society receives 38% of its funds from the pharmaceutical industry, but has "firewalls" that prevent this sum of money from having any effect on how the organization operates. Yet, as the saying goes, "he who pays the piper calls the tune."

The current example, from the UK, highlights how organizations that get substantial commercial support never seem to manage to criticize the policies or actions of those who provide the support. One would think a charity devoted to the interests of patients with a particular disease might protest when drug companies charge outrageous prices for treatments for that disease, but as noted above, not one of the charities listed above did so.

So in the absence of transparency, accountability, and clear and enforced codes of ethics, those with health care goods or services to sell are more than happy to plow substantial funds into non-profit, "grassroots" organizations with the not unreasonable hope that such organizations will then promote the requisite marketing or policy agenda. Thus these supposed "grassroots" organizations are really astroturf, and allow their sponsors to engage in stealth health policy advocacy.

Hat tip to Ed Silverman on PharmaLot.

Thoughts on Charles Nemeroff's Not So Excellent Adventure

The saga of Dr Charles Nemeroff was most recently discussed on Health Care Renewal here. We had first posted about his failure to disclose relevant conflicts of interest relating an article he wrote for a journal he also edited here. Other posts about Nemeroff's questionable behavior are here, here. Nemeroff has also starred in numerous posts on the Clinical Psychology and Psychiatry Blog, amongst others.

Now the tale of how Nemeroff raked in hundreds of thousands of dollars as a paid speaker on behalf of drug marketers, and denied these earnings while he ran a US government funded project meant to evaluate some of the products of his commercial sponsors, has splashed across major newspapers. There has been a lot of good discussion about the case in the blogsphere. (We await, of course, discussion in scholarly medical and health care journals, if it ever appears.)

I did think it was worth weighing in again just to underline some important points about this affair.

It has become common for academic leaders to earn more hawking commercial products than from teaching, research, or patient care. The database unearthed by Senator Grassley just of the speaking fees earned by Dr Nemeroff giving speeches promoting GlaxoSmithKline products is breath-taking. As noted by the anonymous blogger on the Clinical Psychology and Psychiatry Blog, Nemeroff was earning on average more than $20K a month from GlaxoSmithKline alone. That was from only one company. As that blogger also noted, Nemeroff at one point was a consultant for 18 companies, if I counted right, and gave paid talks for 4. Here is the actual relevant part of the disclosure statement.

[Nemeroff] has been a consultant to Abbott Laboratories, Acadia Pharmaceuticals, Bristol-Myers Squibb, Corcept Therapeutics, Cypress Bioscience, Cyberonics, Eli Lilly and Co, Entrepreneur’s Fund, Forest Laboratories, Inc, GlaxoSmithKline, i3 DLN, Janssen Pharmaceutica, Lundbeck, Otsuka America Pharmaceutical, Inc, Pfizer Pharmaceuticals, Quintiles Transnational, UCB Pharma, and Wyeth-Ayerst Laboratories; has been on the speakers bureau for Abbott Laboratories, GlaxoSmithKline, Janssen Pharmaceutica, and Pfizer Pharmaceuticals;

At most medical schools, bringing in money is more important than academic integrity, or anything else. We have previously posted about how one medical school leader explained that faculty who are "taxpayers," that is, bringers of money, are more valued than all others.

The case of Nemeroff shows how big-time taxpayers are now above the law at medical schools. As Dr Howard Brody explained it on the Hooked: Ethics, Medicine and Pharma Blog

[Nemeroff] sent a confidential letter to the dean of the medical school at Emory in May 2000, listing the dozen corporate advisory boards in which he sat. He then ticked off the grants and endowments that those firms had paid to the Department of Psychiatry at Emory, and added, 'Part of the rationale for [the companies'] funding our faculty in such a manner would be my service on those boards.' Translation--you mess with my cozy relationships with these companies, and the industry gravy train to Emory dries up. The threat is only slightly veiled, that should Emory decide to take any serious action against Nemeroff for his unreported conflicts of interest, he could easily jump ship to a more permissive med school, taking a lot of his captive research faculty and all of his industry funding with him.

Lying is an acceptable way to maintain an academic medical leadership position. Senator Grassley's letter to Emory documented this instance:

On several occasions during the life of this grant, it appears that Dr. Nemeroff
failed to report to Emory that he was participating actively on the speaker’s bureau for GSK. For instance, in an email regarding his outside activities dated October 1, 2003, Dr. Nemeroff wrote:
'…I have to dig up the agreement and send it to you, GSK no standing
contract, I chair their ad board 2-3 times per year and I am paid per board
meeting at a standard rate of $5K per weekend.'
However, and based upon information in our possession, in 2003 GSK
paid Dr. Nemeroff about $119,000 in speaking fees and expenses.

$15,000 does not remotely equal $119,000. Stating he was paid the former when he was paid the latter goes beyond "misspeaking."

Bullying helps too. As Dr Brody put it,

Nemeroff is pleased to bear the nickname 'Boss of Bosses.' He has a reputation for wielding tremendous power in psychiatry, especially taking advantage of his leverage with the big drug firms, and is ruthless in attacking those whom he doesn't like or who threaten him. One such event is described in some detail in HOOKED, the hiring and then subsequent firing of David Healy as head of a psychiatric research institute at the University of Toronto, due to Healy saying bad things about Prozac, whose manufacturer, Eli Lilly, was at the time considering a major grant to Toronto. Healy cheerfully sued Toronto and won, meaning that all the correspondence related to the firing is now in the public domain. In HOOKED I focused on Toronto's spineless behavior, but it is also interesting to note that almost certainly, Nemeroff was in the background pulling all the strings that led to Healy's dismissal.

Not only was this a case of bullying, of course, but it was also a case of the trampling of academic freedom, in this case, apparently to support the continuing relationship between pharmaceutical companies, "key opinion leaders," and medical schools, so profitable to these parties, but so detrimental to the integrity of academic medicine and of the clinical research data base.

The case of Charles Nemeroff's not so excellent adventure illustrates the sorry current state of the leadership of academic medicine. As Dr Brody put it,

In today's world, a medical school like Emory looks at all the pluses and minuses of having a guy like Nemeroff as a powerful chair, and decides that the pluses outweigh the minuses. His publication record is stellar (mostly ghostwritten of course), he brings in huge research grants, and people in his specialty all over the world want to kiss the hem of his garments. What has to change, in the regulation and the culture of the academic medical center, so that it becomes a no-brainer that having a guy like this on your faculty is a net loser?

Without such change, the public will fairly start to judge academic medicine's integrity as only slightly better than that of the garbage hauling industry, and that may be too insulting to the garbage hauling industry. It is sad beyond words that the current leadership of these once proud institutions have lead them to this pass, just for a few dollars more.

ADDENDUM (8 October, 2008) - See also comments by Dr Daniel Carlat on the Carlat Psychiatry blog here and here, and by Alison Bass on the Alison Bass blog here.

Doctor Nemeroff Didn't Disclose Glaxo Payments - of a mere $500,000 - Grassley Says

I guess he forgot.

After all, what's half a million dollars? Just pocket change. (Dr. Nemeroff, can this poor journalist have some? I take charity.)

Doctor Didn't Disclose Glaxo Payments, Senator Says

Wall Street Journal
Oct. 4, 2008

A prominent Emory University psychiatrist failed to tell the school about $500,000 he received from drug maker GlaxoSmithKline PLC while heading a government-funded research project studying Glaxo drugs, Sen. Charles Grassley alleged.

The payments to Charles Nemeroff, chairman of the Atlanta university's psychiatry department, compensated him for making presentations to doctors about Glaxo drugs, including its big-selling antidepressant Paxil, according to records Sen. Grassley obtained from Emory and Glaxo. The senator made the allegations in a letter to Emory President James W. Wagner dated Thursday.

Dr. Nemeroff has been a protagonist in numerous Healthcare Renewal pieces before. $500,000 is just part of the windfall:

From 2000 through 2006, Dr. Nemeroff received just over $960,000 from Glaxo, but reported to Emory that he received no more than $35,000, the letter said.

Dr. Nemeroff has been in the spotlight before over earnings from the medical industry. In 2006, he stepped down as editor of the journal Neuropsychopharmacology after The Wall Street Journal reported he wrote favorably in the publication about a depression-treating device but didn't disclose he was a paid consultant to its maker, Cyberonics Inc.

In a June 2004 Emory report obtained by Sen. Grassley, the school concluded Dr. Nemeroff had committed violations of its conflict-of-interest policies. At the time, he had consulting arrangements with about a dozen companies, including Merck & Co., Bristol-Myers Squibb Co. and Eli Lilly & Co.

So there has been trouble in the past. Why is this a "special" problem?

Dr. Nemeroff served from 2003 until this past summer as the primary investigator on a collaborative grant between Emory, Glaxo and the National Institute of Mental Health, a federal agency. The research effort, called the Emory-GSK-NIMH Collaborative Mood Disorders Initiative, had a $3.95 billion budget from the government, and examined five Glaxo drugs considered for use as possible antidepressants.

(10/7 Correction: It appears the WSJ was incorrect and that the budget was $3.95 million, as reported by other sources such as the NY Times.)

I can imagine - hypothetically speaking, of course - that such sums might causes academic leaders to turn a "blind eye" to violations of certain rules and regulations regarding disclosures of industry payments and conflicts of interest by faculty ... just sayin' ....

What is happening in the interim?

Friday evening, Emory released a statement saying that "in view of the ongoing internal and external investigations into these allegations," Dr. Nemeroff had voluntarily stepped down as chairman of the department, pending resolution of the issues.

Voluntarily stepped down? What other choice was there, I ask? That's akin to saying the Axis countries voluntarily surrendered in WW2...

There seems to be a pattern:

On March 19, 2004, the senator said, Dr. Nemeroff addressed questions from Emory's Conflicts of Interest Committee in a letter in which he wrote: "Apart from speaking at national symposia, such as the American Psychiatric Association, for which GSK might serve as a sponsor, my consultation to the company is limited to chairing their Paroxetine Advisory board and for that, I am remunerated $15,000 per year." Paroxetine is the chemical name for Paxil.

Just three days earlier, however, Glaxo paid Dr. Nemeroff $3,500 for a talk he gave on Paxil in Orlando, Fla., Sen. Grassley alleges.

The next day, March 17, he gave another $3,500 talk about Paxil in Kissimmee, Fla. In the week after writing to the conflict-of-interest committee, Dr. Nemeroff gave three talks on Paxil, for $3,500 each, at various locations in New York, according to the senator.

In my estimation, a number of issues need to be addressed if Sen. Grassley's latest allegations are true:

• At the very least, Dr. Nemeroff needs to find himself "persona non grata" in the halls of industry-sponsored drug talks, financial disclosures or not; trust is easily broken, but very hard to repair, and:
  
• The $3.95 million Emory-GSK-NIMH Collaborative Mood Disorders Initiative examining GSK drugs needs to be dissected not just with a fine-toothed comb, but also a scanning electronic microscope for evidence of conflict of interest-mediated biases, tampering, and other potentially invalidating shenanigans.
• Were these payments declared to the IRS and applicable state(s) regarding income taxes?
  

Again, if these allegations are true, this would be a brazen, egregious breach of trust that could rank as one of the largest biomedical research conflict-of-interest scandals, ever.

-- SS

Another Industry-Supported Physician Defends Industrial Support of Medical Societies

The President of the American College of Cardiology (ACC), W Douglas Weaver MD, has written a second editorial on relationships between the ACC and industry, continuing medical education, and conflicts of interest. In his first editorial [ Weaver WD. President's page: disclosures, transparency, and firewalls protect integrity. J Am Coll Cardiol 2008; 52(11): 964-965. Subscription required.] his major points were:

Major activities of the ACC require industry funding - "the Annual Scientific Session would not be possible in its current form if it were not for industry grants and fees from the Exposition."

"Firewalls" provided by the society prevent influence by industry on educational or scientific programs -

Let me assure you that we have very strong firewalls around industry support.

As part of our firewall structure, the College has long-established policies that require strict segregation between the source of commercial support and the use of industry funding. The College adheres to internal and external policies that prohibit companies that provide support from exercising any influence or control over programmatic content, speaker/faculty selection, program format, planning, partnering arrangements, program evaluation methods, and related matters.

Most of the College's commercial support from pharmaceutical and medical device/equipment companies is used for a new or ongoing initiative. For example, the College may solicit support for an educational program on the management of patients with congenital heart disease. Commercial support, in cases such as this, is dedicated or directed to that special objective but with the contractual understanding by the supporter that they will have no influence on how the College uses the funds to support the objective. Unlike unrestricted educational or charitable grants, directed funds are restricted to the designated objective, but the College determines how to use them in accomplishing the objective.

My comment is that is well and good, but it is possible for financial sponsors to exert subtle pressure that such firewalls would not prevent. Sponsors are likely to support educational activities which address topics which can fulfill marketing objectives. In particular, it is often in the interests of such sponsors to highlight, or exaggerate the prevalence of a disease which the sponsor's product can be used to diagnose or treat; to emphasize, or over-emphasize the importance of that disease; and to emphasize, or over-emphasize the benefits and deemphasize the harms of treating the disease. Presentations and publications which have such effects can help the sponsor's marketing objectives, without making crass, overt pitches for its products. It is likely that a professional society which needs substantial support from commercial sponsors will somehow end up providing educational and research presentations that help, or at least do not conflict with sponsors' marketing objectives. It is also likely that a society which needs such support will rarely provide presentations that are critical of these sponsors, their products, and their actions.

In a second article just out [Weaver WD. President's page: understanding the implications of conflict of interest issues. J Am Coll Cardiol 2008; 52(15): 1274-1275] Dr Weaver quantified the amount of support the ACC gets from industry, and again advocated such support as necessary:

Many of you are probably aware that industry supports a broad array of College activities including professional education, quality programs, the Annual Scientific Session Expo, and digital products through educational and other types of grants. This support, which constitutes about 38% of the College's revenues, enables the College to provide programs that we would otherwise not be able to offer. In addition, without this support, the registration fees for the Annual Scientific Session and i2 Summit would have to be more than double their present amount, and member dues would have to increase significantly.

My questions are how could a society which requires such a substantial proportion, 38% of funding from commercial sponsors ignore the preferences of the sponsors for particular topics and content areas? How could such a society dare to allow criticism of the sponsors, their products, or their activities? Knowing that the society is dependent on this level of support, could society leaders really hold industry representatives at arms' length? Knowing that industry supplies more than one-third of their salaries, would society staff really keep industry outside of some bureaucratic, but not concrete "firewall?"

Actually, it was not clear why so much external support was really necessary. The argument was not that the College could not continue its activities without the support. It was, instead, that the College would have to increase membership dues and meeting fees to do so. Perhaps College members would be willing to pay more to continue these activities to questions about industry influence on them? If College members, however, would not think that these activities are not worthy of their support via dues and fees, maybe these activities are not so important after all?

At the end of this first editorial, Dr Weaver declared:

The College does everything possible to ensure that our scientific and educational activities are protected from conflict of interest. Disclosure, transparency, and secure firewalls between commercial support and program content and implementation enable us to use such funding for education and other programs aimed at improving the quality of care to patients without sacrificing our integrity.

I would urge him to reconsider that. I do not have sufficient time or resources to scrutinize all the activities of the College, but I would not be surprised if an impartial assessment might show that they may tend to emphasize clinical areas most of interest to the College's commercial sponsors, while perhaps slighting other areas that are not of interest to them, but are still important to patient care. They may also want to take a skeptical look to see if these activities really are fully balanced in their assessment of the harms and benefits of sponsors' products and activities.

For example, a while back, we posted about an ACC statement that patients taking ezetimibe for cholesterol reduction should continue to take the drug after a controversy about a study which failed to show that the drug had any benefits. At that time, ezetimibe had never been shown to have any clear benefits on clinical outcomes, that is, it had never been shown to decrease symptoms, improve function, prevent morbid events, or prolong life. So why would the ACC advocate that patients continue to take a drug which may do no good? Could it have to do with previous funding the society had received from a company that makes the drug?


Finally, I urge Dr Weaver to take to heart his vigorous defense of transparency and disclosure. As noted above, he has now written two editorials that defend the substantial industry funding his organization receives, and deny the possibility that the large infusion of money could possibly affect organizational decision making. Yet in these editorials he did not disclose any of his own relationships with industry, which appear to be not insubstantial.

Several papers which he authored in the last few years disclosed that he had apparently significant financial relationships with pharmaceutical companies.

• Mahaffey KW, Granger CB, Nicolau JC et al. Effect of pexelizumab, an anti-C5 complement antibody, as adjunctive therapy in fibrinolysis in acute myocardial infarction. Circ 2003; 108: 1176-1183. Subscription required. This disclosed "Drs Mahaffey, Granger, Nicolau, Ruzyllo, Weaver, Theroux, Hochman, and Armnstrong have received consultation fees and/or research grants from Procter & Gamble Pharmaceuticals and Alexion Pharmaceuticals."
• Hudson MP, Armstrong PW, Ruzyllo W et al. Effects of selective matrix metalloproteinase inhibitor (PG-116800) to prevent ventricular modeling after myocardial infarction: results of the PREMIER (prevention of myocardial infarction early remodeling) trial. J Am Coll Cardiol 2006; 48: 15-20. Subscription required. This disclosed "this study was funded by Procter & Gamble Pharmaceuticals...." Furthermore, "Drs Ruzyllo, Quinones, Theroux, and Weaver received consultancy fees for participating on PREMIER Trial Expert Panel."
• The APEX AMI Investigators. Pexelizumab for acute ST-elevation myocardial infarction in patients undergoing primary percutaneous coronary intervention: a randomized controlled trial. JAMA 2007; 297: 43-51. Dr Weaver was listed as a member of "authors and steering committee members." The paper disclosed "members of the Steering Committee received honoraria for their participation." "The study was jointly funded by Procter & Gamble and Alexion Pharmaceuticals."
• Prisant LM, Thomas KL, Lewis EF et al. Racial analysis of patients with myocardial infarction complicated by heart failure an/or left ventricular dysfunction treated with valsartan, captopril or both. J Am Coll Cardiol 2008; 51:1865-1871. Subscription required. It disclosed "all of the authors have received grant support or consulting fees from the sponsor of the VALIANT (VALsartin in Acute myocardial iNfarcTion) study, Novartis, as well as from multiple other manufacturers of cardiovascular drugs."

In addition, a recent news articles in which Dr Weaver was interviewed also disclosed relationships with industry. This MedPage Today 2008 article disclosed "Dr Waver declared grant support from Proctor and Gamble and Schering-Plough and equity or stock interest in Acorn Cardiovascular."

So Dr Weaver seems to be another in a series of defenders of financial ties between physicians and medical societies and industry written by people who fail to disclose their own personal financial ties to industry. Perhaps having one's own cozy relationships with industry makes it hard to realize why people without such relationships may see them as a source of influence, if not outright bias. For other recent examples of stealth health policy advocacy, see this and this (which involved Dr Weaver's colleague, the editor of the JACC.)

I would submit that if medical societies want to avoid questions about their integrity, they ought to find ways to fund their activities through their members' dues and contributions, and without lavish contributions from industry, supposed "firewalls" notwithstanding.

Walgreen Settles

Here is the next story in what seems like an endless succession of prominent health care companies settling lawsuits alleging improper behavior, via the Minneapolis Star-Tribune:

Walgreens has paid the United States and Minnesota and three other states nearly $10 million to resolve allegations of falsely billing Medicaid, the U.S. Justice Department announced Monday, with some of that money going to two Twin Cities pharmacists who turned in the industry giant.

Illinois-based Walgreens charged Minnesota, Florida, Michigan and Massachusetts as if some Medicaid recipients were uninsured, the Justice Department said, when those members were actually covered by Medicaid and by private insurance. The department said Walgreen was entitled to a copay, but instead, charged the difference between what the insurance companies paid for the drugs and what the Medicaid programs would have paid if the recipients were uninsured.

As a result of this improper billing, Walgreens received reimbursement amounts from the states' Medicaid programs that were higher than it was entitled to receive.

Walgreens spokesman Michael Polzin blamed the problem on 'inadvertent billing errors' because of a 'unique requirement for Medicaid billing when Medicaid is a secondary insurer.'

This is the second settlement of this kind we have discussed this week. Its immediate predecessor was the Cephalon settlement. Earlier this year we discussed settlements by Staten Island University Hospital, Amerigroup, UnitedHealth, Anthem Blue Cross and Blue Shield, and HealthMarkets, Express Scripts, Kyphon (Medtronic subsidiary) and Merck. Of course, to these could be added various other ethical lapses, including some involving guilty pleas to criminal charges (e.g., Biovail, and at UMDNJ)

Juxtaposing these events in a procession suggests there are serious systemic ethical problems in the leadership of health care organizations. Moreover, these problems likely have cumulative adverse effects on heath care costs, access and quality, and on the morale of health care professionals. However, outside of Health Care Renewal, there seems to be almost no discussion that so juxtaposes them. In particular, try to find any mention of them in the health services research, health care research and health care policy literature.

Furthermore, while these settlements serve to mark the unethical behavior of the organizations and individuals involved, they never seem to have a large enough monetary value to actually discourage such behavior. As long as health care leaders can shrug off the consequences of unethical behavior merely as acceptable costs of doing business, absent any serious attempts to get health care organizations to enforce internal codes of ethical behavior or to avoid hiring ethically challenged leaders, the procession will likely continue. The effects will be continually rising costs, declining quality, shrinking access, and rising numbers of demoralized health professionals.

Maybe at a time when many people see arrogant, greedy, and unethical executives as the main reason our financial system seems to be in incipient collapse, they will also realize that the same sorts of executives may be a major cause of our ongoing health care crisis.

What's a life worth to Cephalon and its stockholders?

Apparently, not very much, considering their off-label promotions of opiate-laced lollipops.

Cephalon settles charges for $425 million

Linda Loyd
Philadelphia Inquirer Staff Writer

Posted on Tue, Sep. 30, 2008

In what prosecutors called the largest health-care settlement in federal court here, Cephalon Inc. will pay $425 million to settle criminal and civil charges that it illegally marketed three of its drugs.

The Frazer company is expected to plead guilty in U.S. District Court to one misdemeanor criminal charge, the U.S. Attorney's Office in Philadelphia announced yesterday.

Cephalon, a biopharmaceutical company based in Chester County, previously announced last November an "agreement in principle" with the U.S. attorney and Justice Department over an investigation that began in 2003 of its "off-label" promotion and sales of pain medication Actiq, Provigil for sleep disorders, and Gabitril for epilepsy.

Cephalon said yesterday that it had reached separate agreements with attorneys general in Connecticut and Massachusetts to settle related probes.

The drug manufacturer will pay $6.15 million to Connecticut and $700,000 to Massachusetts.

That's the cost of "doing business" to unscrupulous drug marketering and salesforce leaders:

Cephalon's off-label campaigns were successful. Actiq sales jumped from $50.1 million in 2001 to $550.4 million in 2006.

Gabitril revenue rose from $24.6 million in 2001 to $87.3 million in 2004, and Provigil sales from $146.2 million in 2001 to $691.7 million in 2006, the government said.

What's the problem with the strategy of off-label advertising?

While doctors are free to prescribe medicines for any condition they believe appropriate, drug manufacturers can promote products in the United States only for FDA-approved uses.

Were leaders at Cephalon, I add, hired and trained and unleashed without that knowledge? Or did they deliberately flout the law? And if so, have the individuals involved been properly held accountable?

Law enforcement authorities began seeing misuse of Actiq by people who also abused OxyContin and other narcotic painkillers in 2004. Actiq had the street name "perc-o-pops."

Actiq, a berry-flavored cancer-pain treatment on a stick, is approved to treat bouts of severe cancer pain in patients who can tolerate opiods such as morphine. But Cephalon promoted it to treat migraines and backaches, prosecutors said .... acting U.S. Attorney Laurie Magid said at a news briefing "We know in the case of these drugs, patients were harmed, including death, when there was off-label use."

Treatment of migraines and backaches with a drug used to treat pain of metastatic cancer?? The former are just the complaints many addicts use in ED's and doctor's offices to get drugs.

I spent the early part of my career trying to convince public transit vehicle operators, police, fire, and other mission-critical personnel not to abuse drugs, and oversaw testing for same.

Now, here come the pharmas, encouraging physicians (some of them - a minority - unscrupulous themselves, but others naive or misled by drug reps and advertising) to prescribe questionable drugs resulting in harm to innocent patients, abuses by dishonest "patient-actors", and support of the street drug trade.

How did this practice come to light?

In January 2003, a former Cephalon sales representative in Ohio, Bruce Boise, contacted the FDA about Cephalon's sales practices. Boise wore an undercover wire to a company sales conference to help the government gather evidence, according to his Washington-based attorney, Peter Chatfield.

In November 2003, another Cephalon sales representative, Lucia Paccione, of Philadelphia, filed the first of four qui tam "whistle-blower" lawsuits. The complaints were unsealed yesterday.

In this case, four whistle-blowers will divide about $46.5 million plus accrued interest, prosecutors said.

The ultimate costs to the company?

News of the settlement, known to Wall Street for months, barely budged Cephalon's stock price. Shares closed down $1.31, or 1.64 percent, at $78.57. Cephalon had reserved the $425 million for the federal settlement last year.

In summary, the life of an unsuspecting patient who takes Cepahalon drugs for off-label uses that were illegally advertised and then suffers harm, and the life of those addicted to drugs, seem worth little to Cephalon and its stockholders.

In my opinion, as long as this pharma/stockholder/cost-of-doing-business dystopia continues, we can look forward to an unending stream of this type of situation.

The penalties for this type of conduct need to be escalated. Instead of just a fine of $425 million, how about the addition of long prison sentences and exclusion from any further involvement in biomedicine - for life - for the perps?

-- SS

BLOGSCAN - Duplicate Publication about an SSRI

On the Clinical Psychology and Psychiatry Blog, the anonymous blogger described an interesting example of apparent dual publication on a selective serotonin reuptake inhibitor (SSRI) anti-depressant drug, duloxetine (Cymbalta, manufactured by Eli Lilly). Important aspects of the story include how both articles draw conclusions that go well beyond the (same) data in their enthusiasm for the drug in question, and how the second article incorporated an author not found in the first, an author who also happened to be the co-editor in chief of the journal in which the second article appeared, and the leader of an important medical society. This author has been the subject of previous posts (like this one), on Health Care Renewal.

Update on the NIH “Trial to Assess Chelation Therapy”

(Some of the following is identical to a post on Science-Based Medicine dated 9/26/08.)

A few days ago, while gathering information for a post on Science-Based Medicine about intravenous hydrogen peroxide, I noticed this:

ACAM Supports NIH Decision to Suspend TACT Trial

September 3, 2008, Laguna Hills, Calif. — The American College for Advancement in Medicine, ACAM today announced its support for the National Institute for Health’s (NIH) decision to suspend patient accrual of the Trial to Assess Chelation Therapy (TACT) Trial until allegations of impropriety can be proven false. ACAM believes that the TACT trial represents a important milestone in assessing the role of chelation therapy in modern healthcare and respects the decision of the NIH.

ACAM continue to work with Dr Tony Lamas to answer the unfounded allegations of impropriety.

“We believe that the Office of Human Research Protection (OHRP) will find that the allegations are of a political nature. To serve the best interests of participants enrolled in the TACT trial and all patients and their physicians who seek answers about chelation therapy, we call for a swift end to the moratorium and resumption of the trial,” said Jeanne Drisko, MD, President of ACAM.

I alerted a few others, including Stephen Barrett of Quackwatch, who queried the news room of the National Heart, Lung and Blood Institute (NHLBI: the joint sponsor, along with the NCCAM, of the trial) and got this reply:

The investigators and institutions performing the Trial to Assess Chelation Therapy (TACT), in conjunction with their Institutional Review Boards, have temporarily and voluntarily suspended enrollment of new participants in the study. NIH has not issued any announcement or press release about this action. To contact the Office for Human Research Protections’ (OHRP) press office, call Pat El-Hinnawy, (202) 253-0458.

The “allegations of impropriety” mentioned in the ACAM press release had been made by my co-authors and me in a comprehensive article previously introduced on Health Care Renewal here. The article is available in its entirety here. In June, we made a formal complaint to the federal Office of Human Research Protections (OHRP), citing that article and additional information posted on Science-Based Medicine here. That our complaint was the instigating factor for the recent “decision to suspend patient accrual” is suggested by an email that I received last week:

I would like to know who is paying you guys off. Finally we have a chance to assess Chelation therapy and put the issue to rest and to find out whether or not it really works and you bozos screw it all up. I know that the trial was stopped and it is your fault. What are you afraid of? Why are you not decrying all of the injuries caused by medications and unnecessary surgeries? Why are we the citizens of the US deprived of a trial of EDTA so that we can judge for ourselves?

Anyone who is a thinking man, can only be disappointed in you. [sic]

Binyamin Rothstein, D.O.

Rothstein, unlike many of his fellow ACAM members, does not appear to be a TACT investigator. Like them, however, he touts chelation, intravenous hydrogen peroxide, and other baseless and dangerous treatments. He has harmed patients, his protestations nothwithstanding. His medical license was revoked in 2005, but that hasn’t hindered him from using smoke and mirrors in his relentless pursuit of profit from nonsense. He’s even managed to promote himself to the public without revealing key items from his resumé—one of the many reasons that even the most diligent regulation can’t always protect the public from scoundrels.

At least two reporters have recently covered the story (here and here). They mostly get it right. The AP report, however, states that chelation "is mainly used to treat lead poisoning." That is not technically false, but is misleading because disodium EDTA (Na2EDTA), the drug used in the TACT, has never been approved for lead poisoning and is considerably more dangerous than calcium EDTA, the drug that is so approved. Ironically, one of our objections to the TACT is that its literature---including protocols, consent forms, and subject recruitment pitches---conflates the two drugs so as to make the study drug appear safer than it is.

Indeed, the FDA has recently withdrawn its approval of Na2EDTA, citing "important safety information" and the possibility that it may be confused with the less dangerous CaEDTA:

As noted in the January 16, 2008, Public Health Advisory, there have been cases where children and adults have died when they were mistakenly given edetate disodium instead of edetate calcium disodium (calcium disodium versenate) or when edetate disodium was used for indications other than those approved by FDA.

Readers might remember that we at HCR have previously discussed the important distinction between the two EDTA salts, after a 5-year old boy was killed in Pennsylvania when a quack administered Na2EDTA to him as a treatment for autism. At the time a CDC expert was so surprised that anyone would infuse Na2EDTA that she concluded, erroneously, that it must have been a drug error: "a case of look-alike/sound-alike medications." The PA medical board's investigation subsequently confirmed that the practitioner had intended to give Na2EDTA, exactly as we had predicted.

The TACT should now be stopped altogether. Contrary to the ACAM press release, our objections to the TACT are scrupulously documented and not “of a political nature.” They are of a scientific and ethical nature. They will not be proven false, because the evidence for them is overwhelming.

Did Mrs. Jones receive her off-label failed spinal implant via excellent informatics data, or via a surgeon's visit to a prostitute?

In a story that leaves me at a loss for what has become of medical ethics, I read that Medtronic stands accused of, among other marketing tactics, inducing surgeons to use its spinal implant devices via kickbacks and outings to a now-closed Memphis strip club whose owners pleaded guilty to dancers engaging in acts of prostitution.

Apparently the devices were being used extensively for off-label uses, resulting in unexpected adverse events, some quite serious in nature.

I could not have made up this rather sordid story if I tried:

Wall Street Journal
Sept. 25, 2008

Lawsuit Says Medtronic Gave Doctors Array of Perks

(subscription required)

A lawsuit brought by a former Medtronic Inc. lawyer alleges the big medical-device maker gave surgeons a variety of incentives to use its products, including regular entertainment at a Memphis strip club, trips to Alaska and patent royalties on inventions they played no part in. The previously undisclosed allegations involve Medtronic's spinal-devices unit, which has $3 billion in annual revenue. The unit's business relationships with doctors who use its spinal-repair implants are being investigated by Sen. Charles Grassley and have been the focus of lawsuits by other former employees.

Sen. Grassley has been looking into whether inducements for doctors, like those alleged in the lawyer's suit, have led to what surgeons say is widespread off-label use of Medtronic spine products.

... Ms Kelley's [whistleblower Ami P. Kelley, a former senior legal counsel for the spine unit] lawsuit says kickbacks were "pervasive" and "the culture and way of doing business" at Medtronic. Sales staff, she said, "routinely took physicians" visiting the spine unit's Memphis headquarters to the Platinum Plus strip club, and picked up the tab for the dancers' services during "VIP visits." In 2007, Platinum Plus's owner pleaded guilty to charges related to dancers engaging in acts of prostitution, and the club has closed.

Ms. Kelley's lawsuit sought to recoup damages for the federal government, which prohibits companies from giving doctors inducements to use products covered by Medicare or Medicaid.

Her lawsuit and a separate one that also accused the spine unit of paying illegal kickbacks to doctors were the basis for a $40 million settlement deal between Medtronic and the government in 2006, according to the settlement document.

"VIP Strip Club" visits for orthopedic surgeons and neurosurgeons? I'm certain that only the most advanced scientific discussions between company and client occurred at such venues.

My questions are:

• Why would any physician allow themself to be taken by a vendor to a strip club? This is a questionable and unprofessional activity on its face, but in the context of vendor marketing to surgeons (presumably male), it is even more appalling. I personally would have rejected such an invitation out of hand as being sleazy and tawdry by its nature.
• Was there a genuine data-driven attempt to evaluate the off-label uses?
• What datasets were being collected by the company and the surgeons to support non-FDA-approved uses of the spinal implant devices?
  
• Who designed those datasets?

Not to mention:

• Did the wives and families of the surgeons know where their husbands and fathers were being taken on their "business trips to Medtronic?"
  

The names of the involved physicians are currently a closely-guarded secret:

The former Medtronic lawyer's allegations are contained in a 2002 suit filed in U.S. District Court in Memphis against Minneapolis-based Medtronic and 10 doctors. The lawsuit and other filings in the case remain sealed, except for a heavily redacted copy of the complaint, which contains none of the doctors' names nor specifics of the allegations.

Medtronic has refused repeated requests from the Senate Finance Committee's staff for an unredacted version. Sen. Grassley, an Iowa Republican, is the panel's ranking minority member.

... The Kelley lawsuit names several top spinal surgeons among the 10 doctor defendants and lists several others as receiving inducements.

The complaint clearly comes from the typical "disgruntled employee":

Ms. Kelley, who now works at another company, alleges she was dismissed by Medtronic after challenging improper payments.

One surgeon's name was apparently made available to the WSJ:

The suit says surgeon Jeffrey Wang, now director of the University of California at Los Angeles's Comprehensive Spine Center, "liked to be taken" to Platinum Plus and emailed Medtronic sales official Brad Hancock saying he was "looking forward to going" to the club with him.

Of course, UCLA has an air-tight explanation for this:

A UCLA spokeswoman said Dr. Wang, who isn't named as a defendant in the suit, "denies ever being entertained by Medtronic at the Platinum club" and doesn't recall sending any such email. If he did send it, she said, "it would have been done so in jest."

In jest? They mean to say, a top surgeon who claims he never went to the club, doesn't recall sending the email --- but if he did actually send it and simply forgot (meaning he would have known a vendor takes doctors on "VIP visits" to strip clubs / houses of prostitution but refused to go himself) then it was just a joke?

On the MedInformaticsMD scale of credibility, that rates about a 0.3 out of 10. It's not even good spin.

All is better now:

Medtronic declined to comment on the lawsuit's allegations. It said it has changed many business practices since the suit was filed, and is "committed to reform and transparency in the industry."

How reassuring.

Actually, not, considering the posts about Medtronic's practices on this blog here, here, here and here, among others.

Also not reassuring was the simplest Google news search on "spinal implant problem medtronic" which returns items like this:

Medtronic Will Settle Accusations on Kickbacks
New York Times - Jul 19, 2006
Medtronic was the subject of two lawsuits filed in Federal District Court in Memphis by whistle-blowers on the actions of its spinal-implant division, ...
All 14 related - Related web pages

Medtronic to settle with doctor over spinal implant invention.
Free with registration - Saint Paul Pioneer Press - AccessMyLibrary.com - Apr 23, 2005
Spinal implant devices are part of a division that accounted for 20 percent of Medtronic's $9.09 billion in total sales last year. In 1999, Medtronic paid ...
Medtronic to Pay $1.35 Bln to End Spinal Doctor... - Bloomberg
Medtronic to buy spine patents, ends legal battle - USA Today
Forbes - San Diego Union Tribune - All 22 related - Related web pages

Medtronic Sofamor Danek's Patent Infringement Lawsuit Begins.
Free with registration - Commercial Appeal - AccessMyLibrary.com - Jun 4, 2004
Medtronic Sofamor Danek and Dr. Gary Michelson are disputing patent rights over the Los Angeles surgeon's inventions in spinal implants, instruments and ...
All 2 related - Related web pages

Medtronic Must Pay Inventor $109 Million, Jury Says (Update3)
Bloomberg - Sep 28, 2004
28 (Bloomberg) -- A US jury told Medtronic Inc., the world's biggest maker of spinal implants, to pay at least $109 million to an inventor for violating ...
Medtronic Must Pay Inventor $109 Million, Jury... - Bloomberg
Memphis, Tenn., jury awards surgeon $110 million... - Commercial Appeal - AccessMyLibrary.com (Free with registration)
All 12 related - Related web pages

Medtronic Must Pay Surgeon $400 Mln Punitive Damages (Update2)
Bloomberg - Oct 12, 2004
Minneapolis-based Medtronic doesn't break out sales of spinal implants. The unit that includes spinal products, as well as ear-nose-and-throat devices, ...
Medtronic ordered to pay $400 million to Los... - Saint Paul Pioneer Press - AccessMyLibrary.com (Free with registration)
$400 Million Judgment Against Medtronic - New York Times
Los Angeles Times - Star Tribune - All 11 related - Related web pages

I'm not even going to attempt to dig any deeper. I fear I may lose my breakfast as a result.

However, hopefully Sen. Grassley and his staff will dig deeper.

A lot deeper.

It's hard for Medical Informaticists and others to help usher in an era of data-driven healthcare when we are competing with strippers and prostitutes for the affection of our surgeons.

-- SS

Addendum:

I am increasingly coming to believe the executive resistance I faced to development of an advanced, very fine-grained, still-used Invasive Cardiology Clinical Database (ICCD) at a major heart center in Delaware late last decade was not based on scientific issues.

This information system could show whether a new device or treatment was effective or not in short order, affecting valuable orders for devices. In fact, in its first year it saved almost $1 million in expense through just that means.

Interestingly, the resistance was from administration and IT, not the doctors, who were the true cheerleaders of the system. Reading the increasingly common stories about the way business is conducted by such companies, I do wonder if cardiac device companies could have been in bed with administration in some way.

Additional addendum 9/28/08:

UC leadership is certainly aware of this issue as well as this posting, after reading it via a Google search on the terms "Medtronic" and "stripper." From the HCRenewal tracking logs:

Domain Name: ucsf.edu ? (Educational)
IP Address: 169.230.242.# (University of California San Francisco)
ISP: University of California, Office of the President
Operating System: Macintosh MacOSX
Browser: Firefox
Time of Visit: Sep 28 2008 6:35:33 pm
Last Page View: Sep 28 2008 6:35:33 pm
Referring URL: http://www.google.co...r&btnG=Google Search
Search Engine: google.com
Search Words: medtronic stripper
Visit Entry Page: http://hcrenewal.blo...eive-her-failed.html
Visit Exit Page: http://hcrenewal.blo...eive-her-failed.html

Brown University Student Journalists Dare to Report on Paxil/ Seroxat, Study 329 and GSK

We have published a few posts about the controversy about the clinical research supporting the use of paroxetine (Paxil, Seroxat in the UK, made by GlaxoSmithKline) in depression (here, here, here, and here.) This controversy includes allegations that clinical research funded by GSK was manipulated, and that the company's marketing for the drug was unsupported by clinical evidence. GSK settled a case alleging fraud in the marketing of Paxil by then NY Attorney General Eliot Spitzer in 2004. A recent article provided arguments and evidence that Study 329, a clinical trial of paroxetine for adolescents, was manipulated , allegedly at least with the acquiescence of Brown University Psychiatry Chair Dr Martin Keller. [Jureidini JN, McHenry LB, Mansfield PR. Clinical trials and drug promotion: selective reporting of study 329. Int J Risk Safety Med 2008; 20: 73-81. Link here.] A book entirely devoted to this controversy, Side Effects by Alison Bass, who started reporting on the case in 1999 for the Boston Globe, was just published.

I am a still proud alumnus of Brown University (undergraduate and medical). I was a full-time faculty member at the University from 1994-2004, and am still a clinical faculty member. Despite Dr Keller's and the University's central role in the case, at least as alleged by Ms Bass and by Jureidini et al, there has only been silence about the case here in Rhode Island.

That just changed. Intrepid reporters from the Brown Daily Herald published two stories on the GSK/ Paxil/ Keller controversy. Both included some important original reporting, as well as providing clear summaries of the issues at hand.

The first article dealt mainly with Keller's alleged conflicts of interest. This article provided confirmation that Senator Charles Grassley (R-Iowa) and the US Senate Finance Committee is, in fact, investigating Dr Keller and Brown University in connection with the controversy. It also included other original reporting, including an acknowledgement from GlaxoSmithKline Director of US Media Relationships Sarah Alspach that the company had provided the committee with full information about the compensation it gave Dr Keller.

The second provided a quite clear explanation of the allegations about the manipulation of Study 329. This article also included results of an interview with Dr Jon Jureidini, the author of an article that dissected study 329, and suggested that it had been manipulated to enhance the apparent benefits of paroxetine, and diminish its apparent risks. The reporters noted that Jureidini was "confident that data in Study 329 were deliberately misrepresented." They were also able to obtain an internal GSK document that acknowledged that study 329 did not prove the efficacy of the drug.

The BDH reporters, Chaz Firestone and Chaz Kelsh, in my opinion, did a fine job, clearly explaining the issues, and digging out some new facts on the case.

Nonetheless, the BDH reporters were not able to get Dr Keller to talk to them, despite several attempts. They were not able to get anyone in the University administration to discuss any substantive aspects of the case. The highest ranking University official who would talk to them was Provost David Kertzer. He asserted that the University "can't discuss particular cases of possible claims of wrongdoing and what we do about them."

In my opinion, and as I said to the reporters, one of the most distressing aspects of this case is the refusal of Dr Keller or anyone in the University to deal with the content of the case. Very serious allegations have been made. If they can be refuted, they should be. If not, stonewalling only increases the impression that the University administration has something to hide.

Furthermore, the case raises important issues about science and clinical medicine. Universities are supposed to be where people can conduct free enquiry. There seems to be no free enquiry at Brown into the issues raised by this case. University administrators should be encouraging free enquiry. Here, they seem to be doing their best to avoid, if not stifle it.

Today, the BDH published its own editorial on the case, suggesting that Dr Keller's "actions directly affect the integrity of the University." If so, the University community should, at the very least, be discussing these actions, how they affect this integrity, and what ought to be done about it. Unfortunately, I am not optimistic that there will be an open discussion of these issues, even after the brave publication of these articles. The University administration seems to have some reason they want to clamp a lid on this case, and I am afraid they will continue to do so. The medical school faculty, lacking tenure and remembering what happened to previous dissenters like Dr David Kern, are likely to be too scared to push that lid away. Woe unto Brown.

See also comments on the Alison Bass Blog, PharmaGossip, and Pharmalot.

ADDENDUM (29 September, 2008) - See also this post on the Alison Bass blog, with links to some of the original documents relevant to study 329.

Failed "Masters of the Universe" Running a Renowned Teaching Hospital

The Wall Street Journal Health Blog recently reported about some New York City hospitals worried about the current financial/ economic crisis, but for interesting reasons:

To give you a sense of how the crisis on Wall Street is affecting New York hospitals, we need only provide the names of some financial execs who are on the board and donor list of of New York-Presbyterian Hospital.

The chairman of the board is John Mack, Chairman and CEO of Morgan Stanley — you know, that big investment bank that just scrapped its business model? Serving alongside him was Richard Fuld, CEO of Lehman Brothers, the one that’s now reorganizing under bankruptcy protection. Another board member is John Thain, CEO of Merrill Lynch, which is selling itself to Bank of America. The hospital’s chairman emeritus is Maurice “Hank” Greenberg, former chairman and CEO of AIG, the insurance titan effectively taken over by the government.

Hospital execs worry that now just might not be the time to call their friends on Wall Street to ask for donations.

I will make a bet that if one were to get lists of the top current and recent former leaders of all the financial corporations that have just failed, one way or the other, in particular, Bear Stearns, Lehman Brothers, Merrill Lynch, Fannie Mae, Freddie Mac, and AIG, you would find quite a few who also have leadership positions (often as board members) of important health care organizations, both for-profit and not-for-profit. For example, we noted that the former CEO of Fannie Mae, James A Johnson, who was forced out after an accounting scandal that presaged the current plight of the company, was also a board member of UnitedHealth, and had approved the outlandish compensation given to now prematurely retired UnitedHealth CEO Dr William McGuire.

But the board members of a not-for-profit teaching hospital are not just supposed to be a group of the largest contributors. The board of directors or trustees of a not-for-profit institution provides the highest and final layer of oversight for the organization. Hospital executives are supposed to answer to, and are hired and fired by the board. The board has ethical, and in some states legal responsibilities to uphold the mission of the organization, and when making decisions for the organization, to put the mission and the interests of the organization ahead of personal interests.

So it seems reasonable that all the board members of not-for-profit hospitals should be devoted to the mission of the hospital, and the values that underlie it. Furthermore, it seems reasonable that all board members should at least either have substantial knowledge about the health care context, and/or have considerable intelligence and leadership abilities.

However, the board of this one illustrious teaching hospital included four corporate executives who had no particular knowledge of health care. They have now been shown to have lead spectacularly failed corporations, corporations whose failures have contributed to what some people now call the biggest economic crisis since the great depression. This is not a great testament to the intelligence and leadership abilities of these former "masters of the universe," although it is perhaps a testament to their ability to promote themselves.

So whoever is now responsible for leading the hospital, and beyond that, all those who are concerned about the reputation of the hospital and its ability to fulfill its mission should be wondering why in the world these people were on the board? Furthermore, they should be wondering what was and is wrong with the process that appointed such leaders to this level?

We have frequently discussed how leaders of health care organizations have often proved to be autocratic and "imperial," ill-informed about health care, indifferent to the values of health care, isolated and insulated, self-interested, conflicted, or even corrupt. We have contended that such bad leadership is a major, but rarely discussed cause of what has gone wrong with health care.

That arrogant and over-paid CEOs of some of the most spectacularly failed financial corporations of this century were also leading one of the country's (formerly?) great teaching hospitals says something major about what has gone wrong with the leadership of health care.

ADDENDUM (24 September, 2008) - the US Federal Bureau of Investigation (FBI) is now investigating four of the above firms, Fannie Mae, Freddie Mac, Lehman Brothers, and AIG, according to the New York Times.

Are You Ready for Some Football? - St Louis University Hospital Pays to be Official Hospital of the St Louis Rams

The St Louis Post-Dispatch reported on the latest fashions in hospital marketing:

St. Louis University Hospital calls itself the 'official' hospital of the St. Louis Rams on billboards and signs.

But its doctors provide no medical care for the Rams' team.

Team doctor Matt Matava and his colleagues from Washington University School of Medicine since 1995 have provided that service at BJC HealthCare facilities.

SLU Hospital defends the sponsorship deal. 'We're not out there trying to say we take care of the Rams,' said Laura Signaigo, its marketing and communications director. 'This is a marketing agreement.'

Sports teams have sponsorship arrangements with nearly every industry — from banks to breweries. Still, if a hospital calls itself the 'official' hospital of a sports team, do patients — and prospective patients — assume its physicians treat the players?

'Do I think it's clear to the general public (that this is a marketing agreement)? I don't know,' Signaigo said. 'I think the Rams have a product to sell, and I bought it.'

At one time, professional sports teams paid top dollar so their athletes could be treated by the best physicians. Then, the tables turned. Doctors and hospitals began paying teams — at times more than a $1 million a year — for the privilege of treating players.

A survey in 2004 by The New York Times found about half the teams in the four major North American professional leagues were tied contractually to a medical institution, and the numbers were growing. Those arrangements had varying business models. Few, if any, had an arrangement like the Rams and SLU Hospital, where the 'official' hospital did not provide care.

The advertisements never say the hospital's doctors are the Rams' physicians or that the hospital provides care, said Matt Marchal, who at the time was a sales manager for the Rams. He recently changed jobs and now works in insurance.

'They're leveraging the relationship … being associated with a professional football team carries a lot of weight,' Marchal said.

Signaigo also points out the term 'official hospital' is the Rams' terminology. It is supposed to signify a level of sponsorship, not a clinical relationship, she said.

'The purpose from a marketing perspective, in my opinion, is to tie into the positive perceptions that these organizations have with the public,' Signaigo said.

In my humble opinion, the most likely interpretation of a statement that the hospital is the "official" hospital of a sports team would be that the team gets their care at the hospital. The wording on its surface does not suggest that the hospital paid the team for the designation. Thus, this seems to be a particulary cynical way to market a health care institution. But what else should we expect from marketers in health care?

There was once a time when hospitals (and doctors) did not advertise. Those pushing for advertising argued it would lead to more informed patients. To often, however, it seems mainly to lead to deception.

Until 1980, the American Medical Association warned, "the practice of medicine should not be commercialized, nor treated as a commodity in trade."(1) According to Dr Arnold Relman, it was forced to change that position after a 1975 US Supreme Court decision that decreased anti-trust protection for physicians, effectively treating them more as trades people than professionals. Maybe it is time to urge reconsideration of that decision, and more appreciation of the old AMA policy.

References

1. Relman AS. Medical professionalism in a commercial health care market. JAMA 2007; 298: 2668-2670. Link here.

More Lucrative Payments to Orthopedic Surgeons: This Time Consulting Fees By Medtronic to Spine Surgeons

Starting last year, we posted (here, 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. Our last post on this subject noted the minimal disclosure some of the surgeons receiving these huge payments made when writing scholarly articles on related topics.

This month, the Minneapolis Star-Tribune published a series of reports on its investigation of payments made to orthopedic surgeons by medical device maker Medtronic. Unsealed documents from an ongoing lawsuit suggested that this company also made some strikingly large payments to orthopedic surgeons who perform spine surgery. The Star-Tribune's first article focused on a single surgeon:

Dr. David Polly's reputation precedes him and it's worth a lot. Among spine surgeons, this rather unremarkable-looking 51-year-old is a rock star.

Arrayed before him as he spoke at the annual Design of Medical Devices Conference at the University of Minnesota were two dozen doctors, engineers, students and medical device company representatives, some furiously scribbling notes. In this reverential group, Polly's mention of a particular surgical technique or medical device would be golden.

They already knew much about this man with a 29-page résumé. The head of orthopedic spine surgery at the university, Polly has led close to 80 research studies and co-written at least 90 scientific papers on repairing aging, injured and contorted spines. In an era of active baby boomers, many with ailing backs, Polly's specialty is a growth industry.

Polly's paid consulting relationship with Medtronic Inc., the global leader in medical devices, was not a focus of discussion that muggy April day. The Fridley-based firm makes the plates, screws, cages, neurostimulators and bone grafts that largely comprise the toolbox of spine repair.

A recently unsealed whistleblower lawsuit, and Congressional and Justice Department investigations, are finally bringing into public view the practice of handsomely reimbursing top doctors to consult for medical device companies.

The $344,375 in consulting fees Polly allegedly received from Medtronic in 2006, and similar amounts in 2004 and 2005, are only emerging because of a complaint filed in a whistleblower lawsuit by two former Medtronic employees in U.S. District Court in Massachusetts.

Another article focused on another surgeon:

Dr. Kenneth Burkus is quite confident his eight-year relationship as a paid consultant for Fridley-based medical device maker Medtronic Inc. hasn't compromised his patients' care.

The Columbus, Ga., surgeon said he receives royalties for helping to develop the company's artificial neck disc and other products. A whistle-blower lawsuit filed in Massachusetts federal court alleges that he was paid $416,775 for consulting work in 2006.

I thought it might be useful to examine the extent that these two surgeons have disclosed their relationships with Medtronic in their published work.

Dr Polly is by far the more prolific writer. Most of his recent work is in Spine. So I looked at a 2008 review article on treatment of scoliosis for which he was senior author.(1) This is what was disclosed in the article:

Although one or more of the author(s)has/have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of the manuscript, benefits will be directed solely to a research fund, foundation, educational institution, or other non-profit organization which the author(s) has/have been associated. One or more authors has/have received benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript: e.g., honoraria, gifts, consultancies, royalties, stocks, stock options, decision making position.

That was really specific, wasn't it. The disclosure does not identify which author received payments, what company made the payments, how much they were, or what their purpose was.

I found two recent articles authored by Dr Burkus, both again in Spine. The most informative disclosure statement was from an article by Dimar et al(2)

One or more authors has/have received benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript: e.g., honoraria, gifts, consultancies, royalties, stocks, stock options, decision making position.

That wording seems familiar, and presumably is the boilerplate favored by Spine. Of course, it is no more specific here than it was before.

The new investigations by the Star-Tribune suggest that huge payments to orthopedic surgeons by medical device companies are hardly confined to those related to hip and knee prostheses, and that spine surgeons seem no more eager to disclose these payments in any detail to the readers of their research articles than were surgeons who specialized in hip and knee replacement.

So I get to repeat myself. In my humble opinion, a disclosure that a journal article's author received some sort of "benefits" from a company does not quite have the impact of a disclosure that the author received hundreds of thousands of dollars in consulting fees. My concern is that surgeons of the stature of those mentioned in these articles have numerous opportunities to influence the practice of their colleagues, by informal conversations, formal talks, and published writing. These colleagues at least should have the opportunity to decide for themselves whether the surgeons' enthusiasm for spine surgery, especially involving the use of specific products, might just have been a bit influenced by making hundreds of thousands of dollars a year in consulting payments from the manufacturers of those products.

Again, there has been a lot of discussion lately about the effects of small gifts, pens, mugs, and pizza lunches, on physicians. Even small gifts have been shown to influence how people think and act. But if small gifts have some effect, what sort of effect would arise from consulting fees almost enough to make a doctor rich? Inquiring minds want to know.

This is another argument for requiring full and detailed disclosure of all payments made to physicians, and to health care academics, and health care decision makers, beyond their usual salaries or fees, and that could have any bearing on their clinical or health care decision making.



References

1. Lenke LG, Kuklo TR, Ondra S, Polly DW. Rationale behind the current state-of-the-art treatment of scoliosis (in the pedicle screw era). Spine 2008; 33: 1051-1054.

2. Dimar JR, Glassman SD, Burkus KJ, Carreon LY. Clinical outcomes and fusion success at 2 years of single-level instrumented posterolateral fusions with recombinant human bone morphogenetic protein-2/compression resistance matrix versus iliac crest bone graft. Spine 2006; 31: 2534-2539.

Staten Island University Hospital Settles, Again

From the New York Times comes the latest installment of the sorry story of Staten Island (NY) University Hospital:

Staten Island University Hospital has agreed to return $88.9 million that prosecutors say it fraudulently obtained from government health insurance programs, one of the largest settlements of such a claim ever paid by a single hospital.

The settlement, which prosecutors announced Monday, represents the third time in a decade that the hospital, which is the borough’s largest, has paid millions of dollars to resolve civil charges that it knowingly overbilled the government for treatment costs. Prosecutors had accused the hospital of conducting a collection of schemes from 1994 to 2005 that spanned many aspects of its operations, including substance abuse detoxification, inpatient psychiatric care, cancer treatment and the number of residents it had in training.

Two of the charges included in the settlement stemmed from separate whistle-blower lawsuits filed by a former doctor at the hospital and the widow of a cancer patient. Dr. Miguel Tirado, a former director of chemical dependency services at the hospital, accused the hospital of fraudulently billing the state Medicaid and the federal Medicare programs for inpatient alcohol and substance abuse detoxification treatment. Investigators determined that from July 1994 through June 2000, the hospital submitted claims for 12 more beds than it was licensed to use, and hid those beds from state inspectors. To settle those charges, the hospital agreed to return $11.8 million to the federal government and $14.8 million to New York State.

The other whistle-blower suit, filed by Elizabeth M. Ryan of Florida, accused the hospital of using the codes of a cancer treatment covered by Medicare to receive payments for treatment to her husband that was not covered. Investigators determined that the hospital used incorrect billing codes in cancer treatment from 1996 through 2004 to Medicare and Tricare, the United States military’s health insurance program. The hospital agreed to return $25 million to the federal government.

The settlement also resolved two other claims that were not yet the subject of lawsuits. Federal prosecutors said that from 1996 to 2003, the hospital had deliberately inflated its count of residents in training, which resulted in the hospital receiving reimbursements for which it wasn’t entitled. The hospital agreed to return $35.7 million.

Finally, the settlement resolved what prosecutors said were wrongful billings to Medicare and Medicaid for treatment of psychiatric patients in unlicensed beds from July 2003 through September 2005. The hospital agreed to repay the federal government nearly $1.5 million to settle that claim.

In 1999, the hospital entered a settlement with Eliot Spitzer, then the attorney general, to repay $45 million to Medicaid and to provide $39 million in free care for indigent patients. Mr. Spitzer had charged that from 1994 through 1998, the hospital provided therapy to developmentally disabled adults in rooms at group homes, but billed the services as outpatient hospital treatments, which Medicaid reimburses at a rate 10 times higher.

In 2005, Mr. Spitzer’s office negotiated a second settlement with the hospital that required it to return $76.5 million to Medicaid. Mr. Spitzer, who accused the hospital of overbilling through part-time community clinics, said at the time that the hospital’s own lawyers had warned its executives to stop, but the illegal billing continued nonetheless.

We had posted twice before on the 2005 settlement (here and here). It turned out that the former executive vice president of the hospital had been hailed as a leader with "gravitas" after he moved to his next job, which he subsequently quickly quit after his connection with the troubles at Staten Island came to light.

This story again reminds us how often the self-proclaimed leaders with "gravitas" of health care organizations are weighed down with other baggage. This is particularly pertinent during the week when the high priests of finance, the most exalted of the exalted leaders of business, have been shown to have foolishly and arrogantly over-reached. The push to break the medical guild and put managers without health care experience into the leadership of health care organizations unfortunately came at a time when such managers were growing up in a culture of greed, arrogance, and self-interest. So while high-paid chiefs of investment banks are brought low, it is time to rethink whom we have put in charge of health care.

MHRA Report on Influence of Healthcare Blogs

Below is a link to an MHRA-sponsored report (Medicines and Healthcare products Regulatory Agency, the UK equivalent of the FDA) on the "top influencers" in healthcare thinking, including blogs such as this one, Healthcare Renewal.

The MHRA report is here:  link (PDF)

The report is based on data collected regarding seroxat. The results are possibly reflective of, or proportional to, influence on other biomedical topics as well.

It was prepared for the MHRA by Market Sentinel, a company specializing in:

... measuring, monitoring and benchmarking influence in relation to issues, brands and companies. This includes social media monitoring (blogs and messageboards) but is not limited to it. We provide clients in the public and private sector with hard facts that enable them to better understand the playing field; more effectively bring their messages to market and increase their influence ...

... in addition to services such as reputation and crisis management, and optimization of customer targeting in advertising campaigns.The MHRA report became became publicly available after a UK Freedom of Information request, apparently by someone concerned about the seroxat controversy. The full Freedom of Information release containing the report is here (also PDF). The report begins at page 215 of the release, after a somewhat curious, identity-redacted email that states:

"Our intention is not so much to track retail opinion so to speak - the opinion of random unqualified individuals - but to track the opinions of those who matt[er], those with a demonstrated following. Our hypothesis is that it is these "influencers" whose opinions will reach the rest of the world.

We have not so far made recommendations as to who to target amongst these stakeholders, preferring to speak first about the message you wish them to receive."

I presume the "Our" and the "We" refer to Market Sentinel, and the "you" to someone at MHRA or perhaps seroxat manufacturer GlaxoSmithKline in an attempt at "reputational repair" over the seroxat controversy, but this is unclear.

In any case, it appears the Market Sentinel Report was not prepared as a purely academic exercise.
Health care bloggers appear to be doing well, a finding that does not surprise me, aware as I am of the growing influence and power of the political blogs.That healthcare bloggers in general appear to be doing well is a desirable observation, considering the increasing distortion of the biomedical literature by commercial interests that makes attainment of true "evidence based medicine" more difficult.

It is also desirable from the perspective of the "group think" aspect of the peer review process that makes publication of opinion, even well-documented opinion, sometimes impossible if the opinion is "politically incorrect" and/or runs contrary to the collective wisdom, collective exuberance - or the collective pocketbook.

My posts on Medical Informatics and healthcare IT problems, for example, would probably never make it through peer review in the informatics community. They challenge the dominant paradigms and what I believe to be the irrational exuberance over the technology.

I do not write about that issue lightly or without evidence. The American Medical Informatics Association, as just one example, recently decided it would not publish a book on HIT difficulty by several members of the Clinical Information Systems Workgroup in a style similar to my website on that topic (i.e., anonymized, fine-grained case examples), itself a resource that would have been impossible before the Web. The group had to go elsewhere.

I also highly doubt the posts of my colleagues about healthcare corruption and loss of core values would make it past peer review in most mainstream journals, especially in a fashion that would form an "anti anechoic effect" repository or aggregation of such cases.
Healthcare Renewal came out relatively high in influence on the MHRA-commissioned report on seroxat:

... Mainstream media accounts for 30% of the top 100 stakeholders. Media coverage of MHRA is neutral to mildly negative, with the force of emotion mainly targeted at GSK.

The second largest group is bloggers who account for 23% of the 100 most influential stakeholders. The blogs are either written by insiders in the pharmaceutical industry (Doctors, Researchers, Journalists etc) or by individuals who have experienced the effects of Seroxat first hand. Of the industry bloggers, 72% are from the USA and the rest are UK based. For the personal experience bloggers, 60% are based in the UK and the remainder is in the USA.

78% of blogs in the top 100 are written by industry insiders. The most influential industry blog is the American based Health Care Renewal blog. Contributed to by a group of health care professionals, it tackles issues which call into question the values of the health industry.

A highly influential industry blogger is Aubrey Blumsohn who writes the Scientific Misconduct Blog. Not only is he ranked high in influence, but his blog ranks the highest in terms of betweeness’ which measures how many different paths go through a specific stakeholder. Blumsohn is what Malcolm Gladwell would call a “connector”. His old blog, thejabberwock, is still often cited, despite the fact that it is no-longer regularly updated.

Blogger Bob Fiddaman is dedicated to raising the profile of the side effects of Seroxat and regularly posts comments on other blogs, which in turn increases his on-line sphere of influence. A further individual blogger who is highly influential is the author of the Seroxat secrets blog. The entire blog is dedicated to discussing and publishing any issues surrounding the drug, MHRA and GSK.

After Mainstream media and Bloggers, distribution of influence is shared between 12 groups, some of which exist to support those working in the health care industry by supplying information and support ...

Of interest is the citation analysis-like "stakeholder analysis" method used to rate the influence of various Old and New Media outlets. Here is a "stakeholder map" of the top influencers, showing connectedness and information flows (see the MHRA report linked above for a full explanation):

(click diagram to enlarge)

Healthcare Renewal is the red circle at the mid-right network border; size of each node reflects relative influence.Some stats from the report as highlighted by colleague Roy Poses:This blog ranked as 13 in the table of "top influencers." Other highly influential blogs included some cited by us, and/or are on our side-bar list of links. On the ranking of top influencers, Health Care Renewal outranked the Wall Street Journal, Reuters, the UK Times, Nature, Forbes the UK Telegraph, the Annals of Internal Medicine, the Canadian Medical Association Journal, and ABC News, among well known publications. On the ranking of "popular stakeholders," Health Care Renewal came in at 27. We out-ranked Reuters, the UK Times, Nature, CNN, Forbes, the UK Telegraph, and the Canadian Medical Association Journal.

Considering there were only a few posts here on the seroxat controversy, this may have to do with "trustedness" -- i.e., "goodwill" of a sort generated by the plain language, sunlight-as-best-disinfectant coverage of many other issues -- on the hyperlink-driven access patterns and information flows.
The stakeholder analysis shares some aspects of the longitudinal citation analysis methodology such as used to trace the flow of ideas here, but in a hyperlinked web context:

Citation analysis is the examination of the frequency, patterns and graphs of citations in articles and books.[1] [2] It uses citations in scholarly works to establish links to other works or other researchers. It is one of the most widely used methods of bibliometrics. Automated citation analysis has changed the nature of the research allowing millions of citations to be analyzed for large scale patterns.

[1] Rubin, Richard E. Foundations of Library and Information Science 2nd ed. New York: Neal-Schuman, 2004.
[2] Garfield, E. Citation Indexing - Its Theory and Application in Science, Technology and Humanities Philadelphia:ISI Press, 1983.

Although the MHRA-sponsored study has its limitations, blogs can indeed be quite influential. This is a lesson painfully learned by some prominent mainstream media newspeople, politicians, and others.

Perhaps HC blogs should not be dismissed as the work of pajama-clad novice journalists dabbling in their bedrooms.

(The existence of firms specializing in "social media monitoring" suggests that this is starting to be understood in some sectors.)

-- SS