Background
Last year we posted about how two medical societies which received funding from a drug manufacturer tried to persuade the US Food and Drug Administration (FDA) to deny approval of a generic competitor to one of that company's products. The medical societies were the Society of Hospital Medicine (SHM) and the North American Thrombosis Forum (NATF). The company was Sanofi-Aventis and the product involved was its anti-coagulant derivative of heparin, Lovenox.
At the time, we noted that the SHM CEO denied the need to specifically disclose funding from Sanofi-Aventis in the letter to the FDA, since he asserted the letter was about "providing the best, most effective care to the hospitalized patient." If so, I wondered why the SHM had not raised concerns about the case of the deadly contaminated heparin which was sold by another company from which it received support. I noted that as long as medical societies accepted money from companies that made drugs or devices their members might prescribe or use, there would be "suspicion that such societies may use their considerable influence to serve the corporations', not patients' interests, and so undermine the professional values of the societies' members."
The Senate Report
Now the US Senate Finance Committee has reported on their investigation of this incident, and the concerns it raises go beyond just suspicions. As reported by Alicia Mundy in the Wall Street Journal,
The report itself made clear why Sanofi wanted the FDA to delay or deny approval of the generic version of Lovenox:
It also made clear how much financial impact Sanofi had on the SHM:
It made clear that the letter the SHM wrote to the FDA resulted from its interactions with Sanofi:
So let us just walk through this again. Sanofi wanted to keep generic Lovenox off the market. Sanofi pushed two medical societies to which it provided considerable funding to try to persuade the FDA not to approve generic Lovenox, without revealing their financial ties to Sanofi or that Sanofi had instigated their protests. At the time, at least one of the societies' leaders denied that its attempt to persuade the FDA had anything to do with its relationship to Sanofi.
Note that Sanofi's use of two medical societies and a "key opinion leader" to try to influence public policy without disclosing the company's causal role was an example of what Wendell Potter called a "third-party" tactic (see this post). While Mr Potter outlined a series of tactics used by public relations department of health insurance corporations to further their policy objectives, often in such deceptive and systematic ways as to constitute disinformation campaigns, there has not been such a broad description of these these tactics used by other kinds of health care organizations. Now it looks like drug companies' PR departments are also users of these techniques. Most likely they have been deployed throughout the health care sphere to promote policies that benefit particular companies, often at the expense of health care professionals, patients, or the public at large.
On a personal note, I am a general internist who spent some time as an academic hospitalist. The SHM is the main society for hospitalists, and is allied with the Society for General Internal Medicine (e.g., see here), to which I belong, and which I have served in a variety of capacities. Thus I am very sad about the hole into which the SHM leadership has apparently fallen.
The SHM and NATF leadership have apparently become stealth health policy advocates, and actively tried to change government policy on behalf of a corporation that had funded them. Thus, these medical societies acted more like public relations or lobbying firms. In doing so, they appeared to subverted their own missions, and their members' values.
A short time ago, we noted the cases of two medical societies that got substantial funding from drug and device companies, and thus seemed to function more like marketing firms that professional associations. Now we have two cases of medical societies that seemed to function more like public relations and lobbying firms than professional associations.
So all the organizations which ought to have upheld health care professionals' values against the onslaught of laissez faire commercialized medicine, now medical societies as well as academic medical centers, medical schools and their parent universities, and medical and health care foundations, seem to have been systematically sold out to big health care corporations' marketers and public relations flacks.
What Is To Be Done?
If we health care professionals really want to improve patient care and the public health, we could start by exercising extreme skepticism about the funding and leadership intentions of our own professional associations. If these societies appear as dependent on industry for money as they are dependent on their own members, and/or if they appear to be acting more like marketing, public relations or lobbying firms, why do we continue to enable such behavior? Why should we pay dues to marketing, public relations or lobbying firms? We need to have our medical societies uphold their own missions, or we need to get new medical societies.
Hat tip to the Project on Government Oversight (POGO) blog.
Last year we posted about how two medical societies which received funding from a drug manufacturer tried to persuade the US Food and Drug Administration (FDA) to deny approval of a generic competitor to one of that company's products. The medical societies were the Society of Hospital Medicine (SHM) and the North American Thrombosis Forum (NATF). The company was Sanofi-Aventis and the product involved was its anti-coagulant derivative of heparin, Lovenox.
At the time, we noted that the SHM CEO denied the need to specifically disclose funding from Sanofi-Aventis in the letter to the FDA, since he asserted the letter was about "providing the best, most effective care to the hospitalized patient." If so, I wondered why the SHM had not raised concerns about the case of the deadly contaminated heparin which was sold by another company from which it received support. I noted that as long as medical societies accepted money from companies that made drugs or devices their members might prescribe or use, there would be "suspicion that such societies may use their considerable influence to serve the corporations', not patients' interests, and so undermine the professional values of the societies' members."
The Senate Report
Now the US Senate Finance Committee has reported on their investigation of this incident, and the concerns it raises go beyond just suspicions. As reported by Alicia Mundy in the Wall Street Journal,
The Senate report, 'Sanofi's Strategic Use of Third Parties to Influence the FDA,' said the company enlisted medical experts to conduct 'independent interaction' with the FDA to hold on to Lovenox's market.
Between 2007 and 2010, the company contributed more than $2.6 million to the Society of Hospital Medicine; more than $2.3 million to the North American Thrombosis Foundation, which studies blood clots; and more than $260,000 to Dr. Tapson, the report said.
Sen. Max Baucus (D., Mont.), chairman of the Finance Committee, said: 'Pharmaceutical companies simply cannot be allowed to spend millions of dollars to buy medical opinions that claim objectivity but instead favor their products.'
The Society of Hospital Medicine was initially reluctant to write the letter, according to emails released by the committee. The society's director told Sanofi in a June 2008 email that his group 'has no history of making similar comments to the FDA' and might not have 'the expertise or knowledge to say much about' the issue.
However, the email added, 'we want to give any issue that is important to our partner careful consideration.'
Two months later, the society sent its letter to the FDA. A Sanofi public-relations representative later cited the letter in an internal email as a 'key accomplishment.'
The report itself made clear why Sanofi wanted the FDA to delay or deny approval of the generic version of Lovenox:
According to a 2009 Sanofi slide presentation on its 'Lovenox Patient Safety Strategy,' a core issue faced by Sanofi was the 'imminent threat to [Sanofi’s] Lovenox franchise' posed by 'generic alternatives.'
It also made clear how much financial impact Sanofi had on the SHM:
SHM received $2,675,850 from Sanofi from January 2007 through August 11, 2010 for conference exhibits, sponsorship, and grants. Sanofi’s payments to SHM totaled $1,132,500 between July 1, 2007 and June 30, 2009, accounting for 8 percent of SHM’s total revenue during those 2 years.
It made clear that the letter the SHM wrote to the FDA resulted from its interactions with Sanofi:
Internal Sanofi communications indicate that SHM consulted with the American College of Chest Physicians and Dr. Tapson about sending a letter to the FDA after 'a very positive meeting' with Sanofi officials.Summary
So let us just walk through this again. Sanofi wanted to keep generic Lovenox off the market. Sanofi pushed two medical societies to which it provided considerable funding to try to persuade the FDA not to approve generic Lovenox, without revealing their financial ties to Sanofi or that Sanofi had instigated their protests. At the time, at least one of the societies' leaders denied that its attempt to persuade the FDA had anything to do with its relationship to Sanofi.
Note that Sanofi's use of two medical societies and a "key opinion leader" to try to influence public policy without disclosing the company's causal role was an example of what Wendell Potter called a "third-party" tactic (see this post). While Mr Potter outlined a series of tactics used by public relations department of health insurance corporations to further their policy objectives, often in such deceptive and systematic ways as to constitute disinformation campaigns, there has not been such a broad description of these these tactics used by other kinds of health care organizations. Now it looks like drug companies' PR departments are also users of these techniques. Most likely they have been deployed throughout the health care sphere to promote policies that benefit particular companies, often at the expense of health care professionals, patients, or the public at large.
On a personal note, I am a general internist who spent some time as an academic hospitalist. The SHM is the main society for hospitalists, and is allied with the Society for General Internal Medicine (e.g., see here), to which I belong, and which I have served in a variety of capacities. Thus I am very sad about the hole into which the SHM leadership has apparently fallen.
The SHM and NATF leadership have apparently become stealth health policy advocates, and actively tried to change government policy on behalf of a corporation that had funded them. Thus, these medical societies acted more like public relations or lobbying firms. In doing so, they appeared to subverted their own missions, and their members' values.
A short time ago, we noted the cases of two medical societies that got substantial funding from drug and device companies, and thus seemed to function more like marketing firms that professional associations. Now we have two cases of medical societies that seemed to function more like public relations and lobbying firms than professional associations.
So all the organizations which ought to have upheld health care professionals' values against the onslaught of laissez faire commercialized medicine, now medical societies as well as academic medical centers, medical schools and their parent universities, and medical and health care foundations, seem to have been systematically sold out to big health care corporations' marketers and public relations flacks.
What Is To Be Done?
If we health care professionals really want to improve patient care and the public health, we could start by exercising extreme skepticism about the funding and leadership intentions of our own professional associations. If these societies appear as dependent on industry for money as they are dependent on their own members, and/or if they appear to be acting more like marketing, public relations or lobbying firms, why do we continue to enable such behavior? Why should we pay dues to marketing, public relations or lobbying firms? We need to have our medical societies uphold their own missions, or we need to get new medical societies.
Hat tip to the Project on Government Oversight (POGO) blog.
