healthy4u: seeding trials

The Stealth Marketing of Medical Devices: The Biotronik Example

We have frequently discussed the use of organized, deceptive <a href="http://hcrenewal.blogspot.com/search/label/stealth%20marketing">stealth marketing</a> 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 <a href="http://www.nytimes.com/2011/06/01/health/01device.html">reported </a>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 <a href="http://hcrenewal.blogspot.com/search/label/seeding%20trials">discussed</a> them in the context of drug marketing. <blockquote>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.' </blockquote> Influencing Device Choice by Making Referring Doctors Consultants The Times report stated that the company's recent increase in sales was due to <blockquote>the company’s success in developing relationships with doctors who, in turn, can influence which brand of device a patient gets.</blockquote>Here is an example of one type of such a relationship: <blockquote>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.' </blockquote> Also, <blockquote>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. </blockquote> 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. <blockquote>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 <a href="http://hcrenewal.blogspot.com/2011/04/with-this-device-in-your-chest-straight.html">here</a>.] 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. </blockquote> Cultivating Nepotism Finally, here is the use of influence via creating family members' conflicts of interests. <blockquote>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</blockquote> 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 <a href="http://hcrenewal.blogspot.com/2006/01/dodging-stones-thrown-from-glass.html">here</a>.) 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 <a href="http://hcrenewal.blogspot.com/2011/02/health-care-corporate-disinformation.html">here</a>). 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<a href="http://hcrenewal.blogspot.com/2010/11/there-you-go-again-richard-epstein-says.html"> this post</a>.) 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?

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 pharmaceutica...

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Merck Settles Another Vioxx Case

All the shenanigans that went on in the course of Merck's marketing of the now withdrawn Cox-2 inhibitor non-steroidal anti-inflammatory drug Vioxx have provided grist for the <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> mill since 2005.  For example, see these posts: - <a href="http://hcrenewal.blogspot.com/2005/04/more-evidence-of-ghostwriting.html">here</a> about ghost-writing of a Vioxx research publication; - <a href="http://hcrenewal.blogspot.com/2005/06/allegations-that-merck-threatened.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2005/12/more-allegations-that-merck-executives.html">here</a> about allegations that Merck executives tried to intimidate Vioxx critics; - <a href="http://hcrenewal.blogspot.com/2007/03/drug-crazy.html">here </a>about how advocates of an extreme laissez faire approach to regulation of health care corporations used illogical arguments about the Vioxx case; - <a href="http://hcrenewal.blogspot.com/2008/08/article-in-annals-of-internal-medicine.html">here</a> about how an apparently major clinical trial of Vioxx turned out to be a "seeding trial," that is, a study really meant to recruit supposed physician-researchers as prescribers; and - <a href="http://hcrenewal.blogspot.com/2010/01/physician-pleads-guilty-to-fraud-for.html">here</a> about how one once prominent Vioxx researcher pleaded guilty to fraud in connection with his research on other drugs.  Thus, the Vioxx case provides a good lesson about some of the tactics used to deceptively and unethically promote health care products (pharmaceuticals in this case). Merck just announced just the latest settlement of Vioxx related legal actions, as <a href="http://www.businessweek.com/news/2010-02-10/merck-changes-safety-procedures-pays-in-vioxx-suits-update1-.html">reported by Business Week</a>: <blockquote>Merck & Co. agreed to settle shareholder lawsuits over the withdrawn Vioxx painkiller by strengthening its drug-safety procedures, appointing a new chief medical officer and paying $12.2 million in legal fees. Merck would appoint one committee to address risks that require immediate action and another to monitor the safety of drugs, the company said in a regulatory filing. Merck would also amend its code of conduct to promote scientific and academic integrity as well 'honest communication' with doctors. 'In all research endeavors that are sponsored by Merck, we will refrain from attempting to influence inappropriately the results and conclusions of such research,' according to the amended code. 'We strive for all communications with the medical community to be accurate, truthful and consistent with labeling.'</blockquote> Also, <blockquote>The company will be required to make corporate governance changes and “supplement existing policies and procedures,” ... [a Merck spokesperson] said.</blockquote><blockquote>Merck would submit results of clinical trials to a public registry, with its compliance overseen by an independent third party. The chief medical officer will have an 'executive voice' on product safety issues independent of Merck Research Laboratories. </blockquote>Note that this settlement is only of one type of lawsuit, as described in <a href="http://online.wsj.com/article/SB10001424052748704140104575057231552987908.html">a Wall Street Journal article</a>, <blockquote>The pact, which is pending final court approval, would resolve state and federal shareholder 'derivative' complaints (which are brought by shareholders on behalf of a company) alleging that current and former Merck officers and directors breached their fiduciary duties in handling Vioxx. </blockquote>Merck had already settled thousands of lawsuits, <blockquote>Since the Vioxx controversy erupted, about 27,000 personal-injury lawsuits have been filed, the company says. Merck has been challenging all of the cases and settled many of them. Most notably, it agreed to a pay $4.85 billion to settle personal-injury claims of more than 40,000 people. In another settlement, the company will pay $80 million to resolve 190 claims filed by drug-benefit plans seeking to recover costs of paying for Vioxx use.</blockquote>Merck has lots of other legal actions to go through, <blockquote>The Vioxx litigation remains far from over. The U.S. Supreme Court is weighing a separate shareholder case, seeking billions of dollars in damages from the company. Merck disclosed last year the U.S. Attorney's office in Boston was conducting a grand-jury investigation of Merck's handling of Vioxx. The claims of some 310 plaintiff groups are outstanding in courts in the U.S., according to the securities filing. There are also cases overseas, including Australia and Turkey.</blockquote>So the parade of legal actions and settlements thereof continues.  We believe that the scope of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">this parade</a> provides some sort of index of bad behavior by the health care organizations needing to make such settlements.  Most of these legal results are reported on in the business media, and rarely appear in any medical, health care research, or health policy journals.  I submit that were health care professionals, health care researchers, and health policy makers more systematically aware of these cases, they might realize that unethical and sometimes illegal behavior, often generated by bad leadership unrestrained by poor organizational governance, is a major cause of the current, seemingly intractable health care crisis. One notable attribute of the current Vioxx settlement is that it does mandate some changes in Merck's governance and leadership meant to prevent future cases similar to this one.  These include developing leadership structures and changing the company's code of conduct to emphasize the need for "truthful" communication, and the need to refrain from "inappropriately" influencing research.  On <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> we have discussed numerous examples of deceptive practices by health care organizations, often affecting marketing, and of <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation</a> and <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression</a> of research.  It is a small step forward for one company to commit to honest communications and to not manipulate research.  A better code of conduct may at least be a start towards an <a href="http://hcrenewal.blogspot.com/2009/10/organisational-ethics-policies-primer.html">organizational ethics policy</a>, which in turn may have the potential to actually improve behavior.  On the other hand, typical settlements that involve only monetary damages paid by the organization seem to have little deterrent effect on future bad behavior. Usually, the companies involved only need to pay fines, and no individual who performed, directed or approved unethical or illegal acts suffers any negative consequences. I submit once again that such fines are viewed merely as costs of doing business by the affected companies, and do not deter future bad behavior. Until the people who approve, direct, and perform unethical or illegal acts pay some penalties, expect such acts to continue, at best deterred only slightly by written policies that condemn them. I again suggest that to truly reform health care, we need rigorous regulation of health care organizations that has the power to deter unethical behavior that may risk patients' health

Merck Settles Another Vioxx Case

All the shenanigans that went on in the course of Merck's marketing of the now withdrawn Cox-2 inhibitor non-steroidal anti-inflammatory...

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Boston Scientific (Again) Settles - This Time, Charges of Kickbacks Disguised as Clinical Studies

One would think that the stories about bad behavior by health care organizations would quiet down just before Christmas, but no... As reported <a href="http://www.google.com/hostednews/ap/article/ALeqM5i6EeKMw1uQyqOJxROb_E5H2vMIeQD9CP8M1O0">by the AP</a>: <blockquote>U.S. attorneys in Boston said Wednesday heart device maker Boston Scientific will pay $22 million to resolve allegations its Guidant division paid kickbacks to doctors to get them to use its heart devices. The U.S. Department of Justice said Guidant paid physicians $1,000 to $1,500 each in 2003 and 2004 to participate in four studies, called RaCE, RaCE II, RaCE III, and MERITS. It said the studies were designed to increase sales of pacemakers and defibrillators. Federal officials said the company targeted doctors who favored products made by other companies, hoping the payments would induce them to use Guidant devices more often. They said Guidant submitted claims for payment on the devices to Medicare. Boston Scientific did not admit wrongdoing as part of the civil settlement. Under the agreement, its cardiac rhythm management division will have to publicly disclose payments to physicians on a Web site. Boston Scientific also entered into a corporate integrity agreement. </blockquote> So here we have an example of a "<a href="http://hcrenewal.blogspot.com/2008/08/article-in-annals-of-internal-medicine.html">seeding study</a>," that is, a marketing effort to persuade physicians to prescribe a product disguised as a clinical research study, but for medical devices, not drugs.  Seeding studies seem to combine multiple kinds of unethical behavior, deceptive marketing and manipulated research.  There had been some question in the past whether seeding studies exist, but this is the second recent example to come to light, suggesting that not only do they exist, but that they are used by device as well as pharmaceutical companies. Note that, as <a href="http://www.bloomberg.com/apps/news?pid=20601103&sid=a0ZPcYxXqf88">Bloomberg reports</a>, this is the third major settlement of allegations of bad behavior made by Boston Scientific, <blockquote>The company agreed last month to pay $296 million to settle a Justice Department probe into Guidant’s handling of heart devices and restated third-quarter results. [See post <a href="http://hcrenewal.blogspot.com/2009/11/boston-scientific-to-plead-guilty-of.html">here</a>.] In 2007, Boston Scientific agreed to pay $240 million to settle more than 8,000 lawsuits claiming Guidant hid defects in defibrillators, which are devices that shock the heart back into regular rhythm. </blockquote>Cataloging legal settlements seems to be a useful way to assess the sorts of bad behavior manifested by large health care organizations (see some posts <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">here</a>). However, as we have said frequently, such settlements, including the "corporate integrity agreements" now frequently attached to them, seem to have done little to deter bad behavior.  Usually, the companies involved only need to pay fines, and no individual who performed, directed or approved unethical or illegal acts will suffer any negative consequences. I submit once again that such fines are viewed merely as costs of doing business by the affected companies, and do not deter future bad behavior. I submit that would-be health care reformers who want to improve care, reduce costs and improve access should advocate for real negative consequences for people who implement, direct or approve the various versions of fraud, kickbacks, and miscellaneous corruption and malfeasance we have discussed on Health Care Renewal. By the way, the <a href="http://www.bostonscientific.com/AboutUs/Leadership.bsci/,,/navRelId/1004.1012/seo.serve">board of directors</a> of Boston Scientific includes two noted academics with leadership roles in academic health care.  Marye Anne Fox is the <a href="http://www-chancellor.ucsd.edu/leadership.html">Chancellor of the University of California - San Diego</a>, and hence the leader of a major medical school and academic medical center.  The <a href="http://www.ucsd.edu/explore/about/index.html">university's mission statement</a>, alongside which sits her picture, proclaims it "strives to maintain a climate of fairness, cooperation, and professionalism." Uwe Reinhardt, Professor at Princeton, is a noted health care economist, and <a href="http://economix.blogs.nytimes.com/author/uwe-e-reinhardt/">blogger on the Economix blog</a> for the New York Times.  Perhaps such august academic personages could tell  us how they are assuring that the company they are paid well to oversee upholds, rather than undermines professionalism and fairness.

Boston Scientific (Again) Settles - This Time, Charges of Kickbacks Disguised as Clinical Studies

One would think that the stories about bad behavior by health care organizations would quiet down just before Christmas, but no... As report...

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