Recently in Medical education Category
Today is the 115th anniversary of the first production of x-rays (thank you, Google, for the reminder) and the approximately 27th anniversary that Dr. David C. Sabiston, Jr, pimped yours truly about their discoverer, Wilhelm Roentgen (RENT-gun). No commemoration of historic medical events seems complete without traumatic personal memories of formal education, which also include being presented on rounds with a radiograph of a buckshot shoulder (something like this, if not this) and the ever-popular ruse of showing a chest x-ray of situs inversus...backwards.Google eases or heightens the retentive pain (depending on how jazzed you get by primary sources) by providing, in its ever-expanding Books section, access to Roentgen's original paper, "Eine neue Art von Strahlen." For those who don't read German, a translation ("On a new kind of x-rays") is provided here by the Indian Academy of Sciences.
Radiograph taken by Wilhelm Roentgen on December 22, 1895, of the hand of his wife.
Nah. Just messin' with ya.
But medical residents are extremely reluctant to take off work because of illness. While this is a time-honored fact known to anyone and everyone who's spent time in the field of healthcare, MGH resident Anupam Jena nevertheless felt compelled to conduct a survey on the subject—ostensibly to determine exactly what percentage of residents have worked while sick during the course of a year (specifically 2008-2009). The answer, which is printed in a letter to JAMA: 58%.
That's a lowball figure, IMO. When I was a resident [cue younger generation to roll eyes far, far back into head], working 80-plus-hour weeks at HUP and taking every third night call for 2 years [might as well milk it], an intern or resident would never have dreamed of calling in sick unless he or she were already in the hospital—as a patient. Taking the day, and especially the night, off because you weren't feeling well would be like asking to be excused from the Battle of the Bulge because of trench foot. The resentment engendered in your already spent colleagues, who would have to make up for your absence, was simply not worth it, if you had a speck of pride, integrity, martyrdom...whatever.
Image of Saint Sebastian by Guido Reni from Wikipedia.
Just like in 2008, total income to produce all certified continuing medical education (CME) programs dropped by another 7% last year, from about $2.37 billion in 2008 to $2.18 billion, according to the latest data from the Accreditation Council for CME. But commercial support to publishing/ educational companies, or MECCs, fell even more dramatically—by greater than 20% (which is comparable to the drop observed between 2007 and 2008). Consequently total income to MECCs (which are down from a total number of 144 in 2008 to 135) declined by about 10% (companies evidently made up some of their losses with modest increases in advertising income, money from other sources,* and a slight reduction in expenses).
Here's the cut-up year-to-year table, which provides not only cumulative data, but average total and net incomes per MECC. The cumulative net income (total income minus total expense) and the average net income per MECC in 2009 were about half of what they were in 2007. The explanations: a general reduction in support from commercial sources to all CME providers (down 30% from 2007) and a directed reduction in support to MECCs (down nearly 40% from 2007).
Year Total Income Total Commercial Support Advertising and Exhibits Income Other Income Total Expense 2005 $780,783,394 $594,864,588 $18,757,802 $167,161,004 $598,727,647 2006 $818,772,623 $620,657,405 $15,431,546 $182,683,672 $607,961,083 2007 $830,811,192 $594,419,878 $10,831,027 $225,560,282 $615,705,205 2008 $667,419,787 $463,382,991 $10,054,745 $193,982,051 $509,811,733 2009 $604,024,888 $365,315,693 $11,406,679 $227,302,516 $500,057,330
(N = 148)
(N = 154)
(N = 150)
(N = 144)
(N = 135)
Year Net Income Average Total Income per MECC Average Net Income per MECC 2005 $182,055,747 $5,275,563 $1,230,106 2006 $210,811,540 $5,316,705 $1,368,906 2007 $215,105,987 $5,538,741 $1,434,040 2008 $157,608,054 $4,634,860 $1,094,500 2009 $103,967,558 $4,474,258 $770,130
(No. MECCs)
(N = 148)
(N = 154)
(N = 150)
(N = 144)
(N = 135)
MECCs = medical education-communications companies.
* Like, for example, participant registration fees and "allocations from a provider's parent organization or other internal departments."
So who uses the web to find health information—or should I say, health misinformation?
According to a National Health Interview Survey...
- nearly one half of adults (46%);
- women (51%) more than men (40%); and
- younger adults.
Here's the age-sex breakdown:
Yesterday the Council of Medical Specialty Societies, a nonprofit umbrella group of 32 medical groups, announced its guidelines for interacting with industry. There's nothing particularly new here to shake up the established movement that emphasizes independence from pharma influence and the full disclosure of industry ties. For instance (yawn), the code stresses a distinction between certified continuing medical education (CME) activities and non-CME activities and prohibits ghostwritten articles in society journals.
In its entirety, the code, currently endorsed by 13 member societies,* addresses charitable contributions, corporate sponsorships, educational grants, exhibits and advertising, licensing, research grants, and editorial standards for society journals. The other 19 member societies, including CMSS President James Scully's American Psychiatric Association, have until the end of the year to sign on.
* American Academy of Family Physicians (AAFP)
American Academy of Neurology (AAN)
American Academy of Ophthalmology (AAO)
American Academy of Pediatrics (AAP)
American College of Cardiology (ACC)
Accreditation Council for Continuing Medical Education (ACCME)
American College of Emergency Physicians (ACEP)
American College of Obstetricians and Gynecologists (ACOG)
American College of Physicians (ACP)
American College of Preventive Medicine (ACPM)
American College of Radiology (ACR)
American Society for Radiation Oncology (ASTRO)
American Society of Clinical Oncology (ASCO)
This week, the ACC, as an arena for impassioned conflict, didn't stand solely for the Atlantic Coast Conference. A heated confrontation also occurred at the annual meeting of the American College of Cardiology, where Duke physician Robert Harrington debated the Cleveland Clinic's attention-loving Steve Nissen on the issue of physicians' relationships with industry.
Both cardiologists acknowledged historical examples of the marketing influence that pharma and the medical-device industry have had on professional education and, potentially, medical practice. But Harrington painted a more complex picture, in which physicians and medical journal publishers have been complicit in allowing this influence to happen. While Harrington advocated that ongoing relationships with commercial entities are "critical," he urged clear "firewalls" between physicians (particularly academic physicians) and industry and full access to data from industry-funded research. Harrington also correctly stressed that potential conflicts of interest go beyond money; "scientific hubris" is also in the mix.
And speaking of hubris...
Nissen conversely argued that industry funding to sponsors of continuing medical education (CME) and professional medical societies must cease. He cited a Merck-funded CME program at the ACC's Cardiosource web site, "Optimizing Patient Outcomes in Acute Heart Failure Syndromes: Strategies to Preserve Cardiorenal Function," which was sponsored by an accredited* medical-education communications company (Med-IQ) and the ACC.** Without citing specific examples of undue industry influence in the program, Nissen argued that Merck's reason for sponsoring the program was due to the fact that the company had a novel compound, rolofylline, in development that addressed the condition in question. Nissen called the CME program a "market preparation business activity" and an ultimate "misuse of medical information," primarily because the drug died in phase 3 development. But Nissen failed to acknowledge the obvious follow-up question: How could Merck influence cardiac practice with this particular CME program if rolofylline can never be prescribed?
Using an even more tenuous example, Nissen implied that the American Heart Association had backed away from a study that linked soft-drink consumption with cardiac risk factors and an NEJM-advocated soft-drink tax, on the basis of the AHA's alleged marketing relationship with Coca-Cola. As evidence, Nissen offered up the red-dress logo for The Heart Truth educational campaign, which has been prominently displayed on cans of Diet Coke. Nissed charged that the logo comes from the AHA.
However, on this very circumstantial point, Nissen appears to be wrong in his facts. According to MedPage Today, the logo belongs to the National Heart, Lung, and Blood Institute. Moreover, both the AHA and the NHLBI deny that any money has been exchanged between Coca-Cola and their organizations to produce the campaign. The Heart Truth program is solely funded by government entities, according to an NHLBI spokesperson.
Those physicians who argue that ties between industry and medical practice should be severed may have some valid points, but Steve Nissen didn't deliver their perspective in any compelling fashion in this debate. Like in the recent b-ball champ-ship, the hands-down ACC winner here was (the guy from) Duke.
N.B.--Audio portions of the debate are provided by MedPage Today.
* Nissen called the Accreditation Council for CME, the organization that accredits other organizations to sponsor certified CME, "absolutely pathetic" and a "toothless watchdog."
** Notably the program included faculty from Duke (acknowledged by Nissen) and the Cleveland Clinic (not acknowledged by Nissen).
Image of The Heart Truth campaign logo from the NHLBI web site.
Addendum
: The AHA sponsors the trademarked Go Red for Women campaign, which is supported by Macy's and Merck, according to the campaign web site. The campaign's logo (left), while incorporating a red dress, is distinct from The Heart Truth's logo. Both red-dress logos are trademarked by the DHHS.03/19/10 addendum: Christopher Cannon, Harvard cardiologist and Cardiosource Editor-in-Chief, reviewed the Merck-sponsored CME program that was criticized by Dr. Nissen and provided a lengthy comment at MedPage Today. Among 5 talks, according to Cannon, 4 did not mention Merck's (now defunct) drug in development, rolofylline. The talks covered the pathophysiology and epidemiology of the condition in question, possible interventions, and clinical development. Last a case was presented "where the drug is not mentioned." Cannon counted 130 slides in the CME program, 8 (6%) of which concerned the funder's drug in development. Cannon concluded, "This is I believe a fair balanced program and it does not meet the charaterization [sic] stated by Dr. Nissen."
Once again: I'll attempt to clarify the difference between participating in speakers' bureaus and delivering continuing medical education (CME).
The repeat effort to distinguish the two is prompted by today's newspaper and blog reports of physician Lawrence DuBuske, who decided to give up his academic gig at Harvard when the institution required him to make a choice between speaking for pharma and working at the Brigham and Women's Hospital.
Evidently DuBuske earned nearly $100,000 during April, May, and June of last year for giving Glaxo-paid talks to physicians and decided that the pharma gigs were just too lucrative.* In GSK's second-quarter report, "Fees Paid to US Based Healthcare Professionals for Consulting & Speaking Services," DuBuske's services are described as "speaker" and are apparently distinct from any CME honoraria that he might have received through GSK's educational grants (see, for example, "Grants & Charitable Contributions to US Based Healthcare Organizations").
A quick Google search shows that DuBuske did, in fact, also deliver certified CME programs last year (see here and here). Published disclosures through one of these CME programs reveal that DuBuske participated in the speakers' bureaus of 10 drug companies (including GSK) and received honoraria (assumed to be CME honoraria) through grants from 11 drug companies during the last 12 months (at least).
Distinction Between Speakers' Bureaus and CME
Participation in speakers' bureaus consists of giving talks that are based on slides and talking points created by the drug or medical-device company. The content of these talks must be reviewed by the company's medical-legal department and must adhere to FDA guidelines—for example, they must contain so-called fair-balance information. In essence, a healthcare professional who participates in speakers' bureaus becomes a glorified sales representative (like Daniel Carlat during his speakers' gigs for Wyeth).
Participation in CME requires either the development of educational content or its delivery to other healthcare professionals. In the case of industry-funded CME, funds are procured by an organization that is accredited to produce CME.** This organization—which can be a university-based CME department, a medical professional organization, or a for-profit medical education communications company (MECC)—then recruits faculty and assists them with the development of the educational content. The organization is also instrumental in deciding the format of the CME program (eg, Internet-based activity, dinner meeting) and enforcing recognized guidelines to ensure the independence of the program. Honoraria to faculty that develop or deliver content are paid by the accredited organization from the industry-supplied educational grant. Critics of industry-funded CME (eg, Daniel Carlat) argue that companies unduly influence the content of these CME programs through their indirect or direct pressure on grant recipients.
Policies of Partners Healthcare Regarding Speakers' Bureaus and CME
The newly enforced policies of Partners Healthcare, comprising Harvard's Mass General and Brigham and Women's Hospitals, "ban faculty participation in industry speakers bureaus." However, policies relating to industry funding for CME only address involvement at the institutional level; they do not explicitly prohibit Partners physicians from receiving honoraria for developing or presenting certified industry-funded CME programs.
Industry funding for "educational programs" (whether certified or not) may only be accepted after approval from Partners' newly created Educational Review Board, which requires that support for a specific CME program come from more than one company. Also Partners faculty who earn so much per year from a potential industry sponsor (eg, ≥$20,000) might be prohibited from participating in the creation or delivery of a Partners-produced CME program.
* Whether industry will still want to pay DuBuske to speak after his separation from Harvard is debated.
** In the United States, accreditation is most often bestowed by the Accreditation Council for CME.
In an apparent effort to suppress criticism of industry bias in continuing medical education (CME), Pfizer is giving Stanford $3 million to produce such programs without condition. Specifically the grant will not stipulate therapeutic areas of interest for the educational activities—a major departure from current, recognized standards for US-based CME. A full report, with soup-to-nuts opinions from physicians on Pfizer's new type of pooled CME grant to the university, is available in today's NYT.
However...however.
Decisions have apparently been made that Stanford's Pfizer-funded CME will concentrate on diabetes, cardiovascular disease, smoking cessation, and infections, reports the paper. All of these therapeutic areas are of potential interest to the monolithic company.* For example, Pfizer makes Chantix, a smoking-cessation drug; the blockbuster statin Lipitor; and Caduet, a combo calcium-channel blocker/statin.
Now whether bias is inherent in a CME grant that merely specifies a therapeutic area is up for debate. For instance, see the comments here.
And for the historical record:
- Last year, Pfizer announced that it would no longer directly provide CME grants to medical education communications companies (MECCs), presumably because of the perception of bias in MECC-produced CME.
- In 2004, Pfizer agreed to pay the government $430 million to settle allegations of promoting Neurontin (gabapentin) off-label. One alleged off-label outlet: Pfizer-funded CME.**
* Implying here that it might be hard to find a therapeutic area that is not of interest to Pfizer.
** Also 2 months ago, it was revealed that the protocol-defined primary endpoints in company-funded trials of Neurontin were often changed.
On Friday, the WSJ printed a story by Alicia Mundy, "Health-Bill Disclosure Rule Is Resisted," which revealed that a recently passed health-reform bill in the House would require drug companies to disclose payments made to physicians and third parties, such as medical education communications companies, or MECCs. But the idea is nothing new, and reports of such disclosures have been carried extensively by various news sources, including the WSJ and the related WSJ Health Blog.
Given the scrutiny that financial relationships between pharma and physicians have received of late (thanks largely to the Senate Special Committee on Aging and Senate Finance Committee), several drug companies (for example, Eli Lilly and GSK) have voluntarily offered readily accessible information about payments made to physicians for consultant, advisory, or speaking services, as well as educational grants given to MECCs to produce CME programs.
Resisting disclosure, Mundy reported, is John Kamp, executive director of the Coalition for Healthcare Communication. The Coalition, according to the organization's web site, "defends the right of health professionals and consumers to receive truthful information regarding pharmaceuticals and medical products, as safeguarded by the Constitution of the United States. Founded in 1991, the Coalition represents organizations, rather than individuals, dedicated to assuring the free exchange of scientific information without undue government interference." Among the member groups of the Coalition are the American Association of Advertising Agencies and the Association of Medical Media.
Kamp penned his objection to legislated CME disclosure in a July letter to Senator Herb "I'm Richer Than Croesus and God" Kohl (WI-D), who chairs the Special Committee on Aging. In response to an inquiry from the Committee, Kamp wrote, "Many leading drug and device companies have published all their grants for the world to see, and others are following quickly. Given this trend, the Committee should consider elimination of certified CME reporting in all versions of Health Care Reform bills because they are unneeded, redundant and needlessly expensive [boldface sic]." Mundy quoted Kamp, beginning at "should consider..."; she failed to clarify why Kamp resisted legislated disclosure—thereby misleading her readers to believe that Kamp resists disclosure altogether.
Mundy then segued to Thomas Sullivan, president of a small Maryland-based MECC, Rockpointe, and sole blogger at Policy and Medicine. Although Sullivan reported to Mundy that he's not against legislated CME disclosure from drug companies, he has been openly critical of Senator Kohl's Committee, as well as Senator Chuck Gassley (IA-R), who is the ranking minority member of the Senate Finance Committee. In a September blog post, Sullivan described the efforts of Grassley's investigator, Paul Thacker, into physician-related conflicts of interest with pharma as "witch hunts." (It's a description that Sullivan should have heeded when considering any voluntary cooperation with Senator Kohl's Committee and its chief investigator, Jack Mitchell. But more on Mitchell in a follow-up post.)
In a move that was off-point from her article's lede but apparently designed to shock or embarrass, Mundy then proceeded to report the amount of educational grant money that Sullivan's private company had received from drug firms during the last 3½ years. Evidently Mundy had obtained this proprietary company data through the UCSF's publicly accessible Drug Industry Document Archive, which had received the information from Kohl's Committee.
In July, the Committee had requested "an accounting of the funding received by Rockpointe Corporation from pharmaceutical, medical device and biologics companies." Why the Committee was spending taxpayer dollars investigating the 18-employee, privately owned MECC is anybody's guess.* In any event, Sullivan volunteered the information, writing, "We have discussed with your Chief of Investigations, Jack Mitchell, the business information provided is proprietary. We would appreciate your use of this information in the aggregate, and reasonable protection against this information becoming publicly available." So much for government courtesy.
Mundy proceeded to report the cumulative amount of CME grant money that Rockpointe received from the beginning of 2006 to July 2009 (~$23 million), as well as a breakdown of funds the company received from Medtronic ($802,791 or about $100,350 per CME seminar). She added, "Rockpointe's classes typically addressed ailments that the sponsors' products treat"—an observation that should be news to, well, no one. A drug firm is not going to fund a CME program that is outside its therapeutic area of interest.
What Mundy (most egregiously) failed to do was examine (or ask an independent and knowledgeable physician to examine) Rockpointe's CME programs, to determine if any were biased toward the grantor's product. To do so would have required work, and the possible outcome (namely that Rockpointe's CME programs were not biased) would mean that Mundy wouldn't have much of a story.
But as irresponsible as Mundy's reportage is here, it's nothing compared to the harsh writing of blogger and shrill critic of pharma-funded CME Daniel Carlat—who, curiously enough, posted his arguably libelous rant about Sullivan and his company's finances the day before Mundy's story was published. The timing suggests that Carlat is more than a mere fall-off-a-log quote source for lazy and/or agenda-driven reporters like Mundy.
* In his letter to Senator Kohl (which is available at the UCSF archive), Sullivan wrote, "It is a concern to us that this letter has been directed to Rockpointe as a result of a group meeting that we initiated with the Aging Committee staff. That initiative was intended to provide information, understanding and insight concerning CME and the proposed Physician Payment Sunshine Act. The meeting, and the required time and preparation, constituted a good faith effort to bring relevant information to the Committee. Our intent was to differentiate accredited CME from promotional marketing. Under the credo of "no good deed goes unpunished," this initiative led directly to your singling us out among the hundreds of similar CME providers to submit confidential business records. We have expended considerable time, expense and professional fees identifying, locating, reviewing and organizing nearly 4 years of business records in order to digest and prepare the accurate summary you requested. An inquiry of this nature will likely discourage other concerned "good Samaritans" from exercising their rights as involved citizens to bring issues of concern to the attention of the committee."
Image of Alicia Mundy from the New America Foundation; reproduced through a Creative Commons license.
Earlier this week, the WSJ Health Blog reported on a newly published study by Boston researchers Zinner et al (Participation of academic scientists in relationships with industry. Health Aff (Millwood). 2009;28:1814-1825), who assessed the extent to which academic physicians and other scientists have financial ties with the drug or device industry. The story was also predictably picked up by Ed Silverman at Pharmalot.
The blogs' respective ledes highlighted the finding that about 53% of academic researchers have some kind of financial relationship with industry—an observation plucked from the article's abstract. But if one reads the article, the most face-slapping result, IMNSHO, was the horrifying uniformity of the surveyed respondents: 72% were male, and 77% were white. The ethnic/racial diversity, or obvious lack thereof, is flabbergasting. The only minority represented to any notable extent was "Asian."* Among the 2168 respondents** from clinical or nonclinical "life-science" departments, 22 described themselves as black or African American. That's one percent.
|
Ethnicity/Race |
No. |
% |
|
White |
1705 |
77 |
|
Asian |
314 |
14 |
|
Hispanic, any race |
56 |
3 |
|
Declined to report |
57 |
3 |
|
Other |
47 |
2 |
|
Black or African American |
22 |
1 |
|
|
2201* |
100 |
And it's not as if the survey candidates were cherry picked. The authors selected a random sample of faculty from the life-science departments at the 50 US universities that received the most NIH funding in 2004. Survey responses were collected between December 2006 and March 2007. The findings are, therefore, one hell of an indictment of those making contemporary academic appointments in the life sciences at our top programs.
Unfortunately the authors (who include my favorite, sociologist Eric Campbell) did not address the homogeneity of their survey population; perhaps they believed it to be off point. But such a stunning revelation demands examination.
