The Stealth Marketing of Medical Devices: The Biotronik Example

We have frequently discussed the use of organized, deceptive stealth marketing campaigns to influence physicians to prescribe pharmaceuticals. Now more information is coming to light about similar campaigns to influence physicians to use particular medical devices

As reported in the New York Times, based on documents supplied apparently by a corporate whistleblower, here are some tactics used by a small German device manufacturer, Biotronik:

Seeding Trials

These are ostensibly clinical trials, but designed more to market than to discover meaningful data. We have discussed them in the context of drug marketing.

The message from cardiologists was loud and clear, according to a top executive at a heart device company. The doctors wanted implant makers to produce more clinical trials of devices to help them generate income from research fees.

To compete, 'we must be able to 'answer the bell,'' wrote Thomas V. Brown, an executive vice president at the American subsidiary of Biotronik, a small German firm that makes pacemakers and defibrillators.

Mr. Brown’s charge came in an e-mail last year to fellow Biotronik executives, one of scores of documents involving the company that offer a portrait of an implant industry where producers seek to influence the brand of device that patients receive long before a diagnosis.

The documents show, for example, that device makers recruit not only implant specialists as consultants but also general cardiologists who refer patients. Those cardiologists, called feeders in one of the documents, can benefit by enrolling the referred patients in a company-financed study that can pay a cardiologist up to $4,800 a patient.

A lawyer representing Biotronik, Christopher Myers, said Mr. Brown’s e-mail was sent around the same time that some Biotronik sales officials were asking the company to design 'unscientific studies' to compete with producers offering sham studies 'as a means of funneling money to doctors.'

Influencing Device Choice by Making Referring Doctors Consultants

The Times report stated that the company's recent increase in sales was due to

the company’s success in developing relationships with doctors who, in turn, can influence which brand of device a patient gets.

Here is an example of one type of such a relationship:

The company’s relationship with a general cardiologist in Tucson, Dr. Monty C. Morales, is the subject of several memos.

In mid-2008, Biotronik retained Dr. Morales as a consultant under an arrangement that paid him up to $2,000 a month, company records indicate. And about that same time, Dr. Morales, who does not implant devices, expressed strong opinions about the implant brand his patients should get, according to a report apparently written by a sales representative for a Biotronik distributor called Western Medical.

In that memo, Dr. Morales is described as saying that he would not refer patients to an implant specialist in his same Tucson-area practice, Dr. Darren Peress, unless Dr. Peress started implanting Biotronik devices.

'Currently, Peress does not get any of Morales’ business,' the memo stated. 'Monty will strongly support use and send Peress business if he uses Biotronik.'

Also,

Among the Tucson-area implant specialists to whom Dr. Morales apparently referred his patients was Dr. Benigno F. Decena III, the Western Medical report indicates. Internal Biotronik sales data indicates that Dr. Decena’s usage of the company’s products rose sharply in 2009.

During the 12-month period from February 2009 to January 2010, the monetary value of the Biotronik devices used by Dr. Decena reached $1.1 million, an eightfold increase from the previous 12-month period, data shows.

Influencing Device Choice by Making Device Implanters Consultants

Here is a more direct example of making physicians consultants to influence them to then themselves implant more product.

The Times recently detailed in an article how four implant specialists in Las Vegas sharply increased their use of Biotronik devices in mid-2008, about the same time they became consultants. Those doctors said that it was the quality of Biotronik’s devices, not the payments they had received, that had influenced their choice of implants. Whatever the reason, Biotronik’s revenues apparently skyrocketed. By early 2010, the cumulative monetary value of company devices used by those four physicians alone reached about $16 million, internal Biotronik sales data indicates. [Note: see our post by Cetona on this here.]

The documents point to similar outcomes elsewhere.

An implant specialist in Fullerton, Calif., Duane E. Bridges, became a consultant to Biotronik in mid-2008, company records indicate. The monetary volume of company products used by Dr. Bridges from early 2008 to early 2009 reached about $360,000, then jumped to $1.6 million over the next 12-month period, a greater than fourfold rise, the company data indicates.

Dr. Bridges did not respond to comment; also a lawyer, Anthony Willoughby, who said he represented Dr. Bridges could not be reached for comment.

Another implant specialist who became a company consultant in mid-2008, Dr. Michael Brodsky of Irvine, Calif., increased the dollar value of Biotronik devices he used over those two periods, Biotronik data indicate. The value of company products used by another specialist who became a Biotronik consultant in mid-2008, Dr. Prash Jayaraj of Burbank, Calif., also doubled, company data indicate.

Cultivating Nepotism

Finally, here is the use of influence via creating family members' conflicts of interests.

a widely used industry practice: the hiring by a device maker of a doctor’s spouse or other relative. For example, in plotting strategies to gain sales at one California hospital, Biotronik officials suggested that an implant specialist, whose son and wife both worked for a competitor, might be wooed if Biotronik offered him concessions 'such as studies or even the hiring of his son,' according to an internal company report.

Another company document discussed how the revenues of a sales official sharply dropped after his father, an implant specialist, died unexpectedly in an airplane crash

Summary

Thus, the set of documents the Times obtained suggested that one small device company used a set of tactics to increase sales by influencing doctors to use its products.  The tactics employed included seeding trials, hiring referring doctors as consultants to influence proceduralists to whom they referred to use the company's products, hiring proceduralists directly as consultants to influence them to use the products, and hiring relatives of doctors to influence them to use the products or persuade others to use the products.

There is every reason to suspect that such systematic stealth marketing campaigns are prevalent throughout commercialized health care. We have mainly discussed them in terms of the promotion of pharmaceuticals. The examples above suggest they may be used as often to promote medical devices. There is every reason to think they may also be used to promote other health care goods or services.

This latest set of examples brings up two important points.

Physicians, other health care professionals, and health care academics are frequently employed as consultants. These relationships seemed to be looked up on with much favor not only by those directly involved, but also by the supervisors of those involved who are academic or hospital/ health system employees. Even people who find fault with certain kinds of conflicts of interest affecting health care professionals seem less concerned about consulting relationships  For example, the often cited article by Brennan et al which called for more stringent academic policies on conflicts of interest, including banning small gifts from industry, would allow consulting as long as it were governed by a contract with "specific deliverables," (See our post here.)

Yet we have seen repeated examples of consultancies which seem more designed to market products than actually provide specific consulting advice. We also recently have seen how consulting relationships can cloak third-party strategies used in stealth advocacy campaigns (see post here). So all this would suggest that one should be very skeptical about any consulting relationships by health care professionals or academics unless the reason for and nature of the consulting is very clear, and very clearly not related to marketing or public relations.

Finally, note that many apologists for conflicts of interest affecting health care professionals and academics argue that these relationships are inevitable byproducts of the collaboration with industry needed to drive innovation (e.g., see this post.) We have argued that collaboration does not require industry to pay its professional or academic collaborators. The example above shows how conflicts of interest may be created deliberately by commercial firms for marketing purposes. Such relationships do not appear to be "collaboration" necessary for "innovation."

Health care professionals and educators should think again about whether accepting gifts or money from organizations which sell health care products or services is worth the doubts that such incentives create.  Even if the relationship was not designed to promote a product or service, the desire for continued payments and gifts can influence professional decisions or academic opinions.  Worse, the increasing evidence about the prevalence of stealth marketing and advocacy suggests that any gift or payment not clearly in reciprocity for a very well defined technical service is likely to be a deliberate part of such a campaign.  Is the money really worth the doubts about professionalism and trustworthiness it may create? 

"Repositioning and Rebranding" While UMDNJ Burns (Money)

The management of the University of Medicine and Dentistry of New Jersey (UMDNJ) was back in the harsh media spotlight again. UMDNJ has appeared frequently in posts on this blog. The university now is operating under a federal deferred prosecution agreement with the supervision of a federal monitor (see recent posts here, here, here and here.) We had previously discussed allegations that UMDNJ had offered no-bid contracts, at times requiring no work, to the politically connected; had paid for lobbyists and made political contributions, even though UMDNJ is a state institution; and seemed to be run by political bosses rather than health care professionals. (See post here, with links to previous posts.) Most recently, the costs of all these management shenanigans was estimated to be a whopping $243 million (see post here).

The indefatigable Newark Star-Ledger reported that yet another UMDNJ trustee has resigned. This time the issue was

the federal monitor overseeing the school concluded [trustee] Sterritt had committed ethical and legal violations by pressuring university officials to hire his brother, an admitted alcoholic who lost his license to practice law because of misconduct.

The monitor, former federal Judge Herbert J. Stern, said in the report that staffers within the university's human resources department complained that Sterritt was 'very involved' and 'persistent' in an effort to find his brother a position at UMDNJ -- which they considered unprofessional and unacceptable interference.

The report said UMDNJ staff felt pressure to find employment for Sterritt's brother 'at all costs,' noting he was eventually hired after the job requirements were loosened so he could qualify. However, he was paid at the higher salary of the titled position before it was downgraded, according to the monitor.

The article also cataloged all the other UMDNJ leaders who have left:

In the past eight months, the university has lost its president, who was pressured to leave by Corzine; three other trustees who left after tougher ethics rules were put in place banning even casual business relationships with the school; the dean of the university's School of Osteopathic Medicine and the university's senior vice president for academic affairs, who were both accused of abusing travel and expense accounts; and a senior associate dean, who was fired for abusing his position to help himself, friends and family -- including wielding his influence to get a daughter into medical school.

Meanwhile, the repurcussions of the university's huge financial losses continue. The Star-Ledger also reported that the university will lay off more than 100 staff, raise tuition at the medical and dental schools by four percent, and delay the opening of a new out-patient cancer center at the Newark campus. The interim president warned of "longer waits in the hospital's emergency room for non-critical cases. He predicted patients also will have to wait longer to get appointments at the hospital's clinics, as well as face delays for elective surgery."

But amazingly, despite these cuts, the Star-Ledger further reported that UMDNJ leadership had planned to spend about $2.5 million on a "marketing campaign to spruce up the image of the state's scandal-plagued medical university." This was "the second time the governor's office has killed an image campaign by UMDNJ that it found to be ill-timed or ill-conceived. An earlier media effort was quashed in January under pressure by then-Gov. Richard Codey." (See post here.) " The new plan was to resurrect elements of that plan, in a so-called 'repositioning and rebranding campaign' to highlight UMDNJ's research, aimed at attracting researchers, students and patients to the university's clinical services and its teaching hospital. It included many of the television commercials and print advertisements that had already been produced before the lid had been put on the original marketing effort, officials said." The plan was all set to go forward, but after the Star-Ledger asked the state governor's office to comment on it, "the university was ordered to put the ad campaign on hold indefinitely. That request was made by Stuart Rabner, the governor's chief counsel, who told the university that while image improvement was important for UMDNJ, the $2.5 million expenditure would seem inappropriate at a time when the university was cutting jobs and programs to help address a $25.5 million budget deficit at UMDNJ's University Hospital. "

Ok, UMDNJ is operating under a deferred prosecution agreement, has lost $243 million to mismanagement and other administrative misadventures, has seen the departure of many of its top leaders, is running a deficit and forced to make severe cutbacks. So how do the current leaders respond? - by trying to run a marketing campaign of "repositioning and rebranding?" Is there no problem that can't be papered over by a little repositioning and rebranding?

One correspondent responded to the problems at one of the large pharmaceutical companies by wondering if that company had become "a marketing company that happens to make drugs." Has UMDNJ become "a marketing company that happens to be a health care university?"

Once again, the problem appears to be corporate culture. Health care organizations have attracted leaders who are more interested in marketing than in their fundamental missions. UMDNJ needs leaders who put mission before marketing. Leaders' papering over problems is what lead the university to its current sorry state.

Another UMDNJ Leader Fired

After another brief hiatus, UMDNJ is back in the news again. The university now is operating under a federal deferred prosecution agreement with the supervision of a federal monitor (see most recent posts here, here and here.) We had previously discussed allegations that UMDNJ had offered no-bid contracts, at times requiring no work, to the politically connected; had paid for lobbyists and made political contributions, even though UMDNJ is a state institution; and seemed to be run by political bosses rather than health care professionals. (See post here, with links to previous posts.)

Our most recent post about UMDNJ was about a Federal Bureau of Investigation (FBI) raid on the university's School of Osteopathic Medicine in Stratford, NJ responding to a tip that papers related to the school's relationship to New Jersey state Senator Wayne Bryant (D-Camden) were being shredded in the office of Bryant's political ally, Warren Wallace, the senior associate dean for academic and student affairs at the osteopathic school.

The redoubtable Newark Star-Ledger reported Friday the firing of Dean Wallace. Today, the paper reported on the federal monitor's findings that lead to the firing. These included:

Wallace, whose responsibilities include admissions, worked behind the scenes to get his daughter into medical school. The report says that in a highly unusual decision, the university granted her an interview even though she had failed to submit test scores and other information critical to admission. According to those who have been briefed on the report, his daughter's application did not include the Medical College Aptitude Test scores every medical student must take, letters of recommendation or her required essays on why she should be accepted. Some members of the admissions committee were upset she was even granted an interview. But two members of the school's admissions committee, who acknowledged being contacted beforehand by Wallace, gave her the highest possible interview score.

Records show Wallace interceded to help a friend and neighbor obtain a no-bid contract to provide exclusive cafeteria and catering services for the campus in Stratford worth more than $300,000 over the past three years. The report says Wallace received free meals from the catering service.

Wallace submitted nearly $3,000 in travel expenses through subordinates, who put in for petty cash reimbursements that then were handed over to Wallace. The scheme allowed him to sign off on his own expenses.

Computer files in his office reveal Wallace -- who is also a Gloucester County freeholder and chairman of the Delaware River and Bay Authority -- conducted extensive amounts of outside business while at UMDNJ.

Wallace now is just the latest in a series of UMDNJ leaders who have been forced out, including the former UMDNJ President, former Chair of the UMDNJ board of trustees, and the Dean of the School of Osteopathy.

[ADDENDUM (June 6, 2006): The report is out, and in it, according to the New York Times, federal monitor Herbert J Stern called Mr Wallace's activities "unethical at a minimum." Furthermore, the new chair of the UMDNJ board, Robert J DelTufo, called his behavior "ethically unsavory." And a UMDNJ spokeswoman said, "Dr Wallace's interference with the admissions process was unethical and unacceptable." The Newark Star-Ledger reported that New Jersey Governor Jon Corzine said, "I think it's time for Mr. Wallace to step aside from public life." And the Gloucester County Times revealed the report "states that before a May 15 admissions committee meeting, staff was directed by Wallace to announce to the committee that his daughter was a candidate and that upon acceptance would be interviewed by a member of the faculty who reports to Wallace." After the report was made publich, she withdrew her medical school application.]

As this scandal lurches from one lurid revelation to another, I wonder how difficult it must be for the many honest and hard-working faculty, students, and staff at the institution who continue to fulfill the university's mission, the same mission that was seemingly abandoned by too many of the university's former top leaders.
Perhaps the hope that the university will learn something collectively from this awful experience, and may emerge from this experience as a strong and honest institution again.

We can only hope that the health care community as a whole might learn something from UMDNJ's nightmare. Of course, the community will not learn a thing if it never hears about the story at all.

Thus, the continued envelopment of the UMDNJ story in the anechoic effect remains distressing. I have just searched using PubMed, Google Scholar, and Google, and found absolutely not a single reference to UMDNJ's recent travails in any medical, health care, or health policy journal. The closest my search came was an article in the Spring issue of the Rhode Island American College of Physicians Governor's Newsletter, an article that I wrote.

One of the regular readers of Health Care Renewal suggested that it was frustrating to read so many postings about dreary goings on in health care unleavened by constructive suggestions about what could be done to improve things. Trying to suggest how to fix everything that has gone wrong with the leadership of UMDNJ may not be the place to start. But, instead, let me try this:

CONSTRUCTIVE SUGGESTION:
for the health care professionals reading this, how about writing the editor of your favorite general medical or health care journal, and ask why they have not discussed what has gone wrong at UMDNJ, and what the health care community can learn from these events.

[I would be happy to see others' constructive suggestions in the comments section.]