Good lord almighty. I'm beginning to think that the ACCME should move to Cuba.
The council that bestows accreditation on organizations to provide CME is now proposing that independent physicians or writers who are involved in the production of any kind of promotional material for pharma cannot be involved in the development of content for CME. This would arguably prohibit any non-industry physician involved on a company's advisory board or speakers' bureau from participating in the production and delivery of CME. Likewise, any independent writer who produces promotional material for a company could not be involved in the creation of CME content about the same drug class. Yeesh, what's next, ACCME? Little Mao caps?
The ACCME's new proposal is evidently based on the following:
In May 2008, the Attorney's[sic] General of thirty US states won a judgment against a commercial interest that included the stipulation that a promotional speaker for the commercial interest could not also be a CME speaker, on the same class of drugs discussed in the promotion activity, in a CME activity that received funding from the commercial interest.
As Thomas Sullivan at the Policy and Medicine blog points out, the ACCME's characterization is not exactly accurate. In May 2008, Merck actually agreed to a multistate* settlement (it was not a judgment) regarding its Vioxx ads. With respect to the funding of CME, the settlement indicated that Merck will comply with the ACCME's Standards of Commercial Support (nothing particularly earth-shattering) and that any person acting in a promotional capacity for Merck shall disclose to CME participants this promotional relationship (again, nothing particularly earth-shattering). This settlement also indicated that Merck cannot fund a CME program, if it has foreknowledge that a CME speaker has been a promotional speaker for Merck during the last 12 months (a minor tremor, given that Merck could not recommend CME speakers anyway, according to the ACCME standards).
In addition, the ACCME cites a June report from the AAMC Task Force, which urged academic medical centers to discourage their faculty from participating in industry-sponsored speakers' bureaus. But the Task Force also wrote,
To the extent that academic medical centers choose to allow participation of their faculty and staff in industry-sponsored, FDA-regulated programs, they should develop standards that define appropriate and acceptable involvement.
1. Academic medical centers should require full transparency and disclosure by their personnel to the centers and when participating in such programs; and
2. Academic medical centers should require that payments to academic personnel be only at fair market value.
So the ACCME, given the full details of the Merck settlement and the AAMC opinion, is overgeneralizing and grossly overstepping its purview, IMO, by proposing that non-industry physicians limit their communication to other physicians, depending on the setting. Moreover, the ACCME's proposal would needlessly undermine opportunities for independent medical writers to earn a living.
Or to provide another free-speech comment: Blpppht.
AAMC = Association of American Medical Colleges; ACCME = Accreditation Council for Continuing Medical Education.
* Twenty-nine states and Washington, DC.
I'm not eager to recommend therapy to another MD, but I wouldn't mind if psychiatrist and fervent CME critic Daniel Carlat took up some kind of regular relaxation technique. Perhaps, simply deep-breathing exercises—particularly before posting at his blog.
The effort might otherwise prevent hasty, arguably emotion-driven, and inaccurate assumptions about those who dare to disagree with him on the subject of industry-supported continuing medical education (CME). I am specifically referring to his post yesterday, which referred to online critical comments of a recent BusinessWeek article ("Teaching Doctors—or Selling to Them?"). One of these online comments (which can be found here) was mine, and in addition, I cited the BW author, Arlene Weintraub, at this blog for failing to distinguish between overt pharma marketing and CME and her omission of relevant information about Zimmer Holdings.
What I and other online critics of the BW article apparently failed to do, Dr. Carlat implies, is reveal every darn thing about ourselves in the comment box as a show of transparency. (Of course, Dr. Carlat's focus on the article's critics diverts attention from what is actually justified criticism of the BW article.) Some of the critics, who did provide their names, are (gasp) affiliated with the CME business—which could be easily determined by your basic fall-off-a-log Google sleuthing. With respect to my comment, Dr. Carlat wrote the following:
But wait—there's more!
B. Martin criticizes Weintraub's "inability to differentiate between outright pharma marketing and the current status of industry-funded CME." She does not disclose that she is Barbara Martin, who, on her Pathophilia website, identifies herself as a "formerly practicing board-certified neurologist" who is now a full time writer in the "intriguing world of pharmaceutical marketing and pharma-supported continuing medical education (CME)." I guess that means her job is dependent on industry support of CME.
For perspective, here's my actual comment at the BW site:
B. Martin, MD
Aug 6, 2008 5:24 PM GMT
In addition to Ms. Weintraub's inability to differentiate between outright pharma marketing and the current status of industry-funded CME, she also neglects to indicate that Zimmer's move away from funding MECC-sponsored CME is likely related to the company's Deferred Prosecution Agreement with US Attorneys: http://bmartinmd.com/2008/08/businessweek-engages-in-sloppy.html.
So what I did do was provide a link to this blog, which Dr. Carlat failed to notice or inform his blog readers. For an online comment, at least in my opinion, that's as transparent as cellophane. I would also correct Dr. Carlat's interpretation of my About page. I am indeed a formerly practicing neurologist, and I was employed, after my clinical experience, in pharma marketing and, later, in the CME business (which accounts for my knowledge of CME). Today, I am a full-time, freelance writer; however, it is inaccurate to say that my current job is "dependent on industry support of CME."
There. Deep bloody breath.
While we wait for confirmation and further explanation from the scientific community (and I suspect specifically from Northern Arizona University's Paul Keim) about the forensic evidence that ties Bruce Ivins to the 2001 anthrax attacks, we can comb the documents released today by the DoJ. At least from my perspective, the evidence against Ivins is very compelling.
Among the presented information is the fact that the Ames strain of Bacillus anthracis contained in the mailed letters can be directly linked to a single spore batch, called RMR-1029. This identification was accomplished by the detection of 4 characteristic genetic mutations, which are otherwise not described in the DoJ documents; however, it is possible that these mutations refer to the use of highly mutable single nucleotide repeat (SNR) markers described in a previous post here on the subject.
Of the 16 domestic labs that had RMR-1029 before the 2001 anthrax attacks, only one—the USAMRID facility in Fort Detrick, MD—was located where the identified "federal eagle" envelopes used in the attacks were distributed and sold (Maryland or Virginia).
At Fort Detrick, RMR-1029 was stored in the B3 biocontainment suite in Building 1425, to which Bruce Ivins had "unrestricted access." Moreover, Ivins had been "the sole custodian of RMR-1029 since it was first grown in 1997."
Because the B. anthracis spores in the letters sent to the Post and Tom Brokaw (postmarked 9/18/2001) were physically different* from those contained in the letters to Senators Leahy and Daschle (postmarked 10/9/2001), the investigators concluded that the spore batches were created from the RMR-1029 flask at Fort Detrick on two separate occasions. This conclusion is supported by the presence of a B. subtilis contaminant in the Post/Brokaw letters, which could not have been derived from the Fort Detrick flask.
On the basis of nighttime work records at Fort Detrick, the DoJ proposes that Ivins produced the Post/Brokaw B. anthracis during September 14-16 and the Leahy/Daschle spores sometime from September 28 to October 5. It is important to note that Ivins worked alone during these late-shift periods, and that his work time differed considerably from those of other Fort Detrick researchers with access to RMR-1029.
Probably most damning is the allegation that Ivins stalled the genetic identification of the RMR-1029 batch at Fort Detrick by submitting possibly sabotaged or false samples to the FBI for analysis. Initial samples provided by Ivins in 2002 were unusable, according to the DoJ documents, and a second sample of RMR-1029 from Fort Detrick did not contain the characteristic 4 mutations. In 2004, the FBI seized the RMR-1029 flask, which subsequently indicated a genetic match to the B. anthracis contained in the letters.
A final note of curiosity is the return address provided on the Senators' letters: "4th Grade, Greendale School, Franklin Park, NJ, 08852." Former person of interest Stephen Hatfill had been loosely linked to the fictitious address, owing to erroneous media reports that he lived near a "Greendale Elementary School" while in Zimbabwe. The DoJ documents suggest that the return address may be an indirect reference to the Greendale Baptist Academy in Wisconsin and a related suit filed by the ultra-conservative American Family Association against the Wisconsin Department of Public Services, which was investigating the corporal punishment of a 4th-grade student at the Academy. The DoJ notes that "Mr. and Mrs. Bruce Ivins," who were practicing Catholics, made several donations over the years to the AFA and received the organization's newsletter, which would have referenced the suit.
* Genomic sequencing, however, revealed that the B. anthracis spores in all 4 letters were identical.
Scanning electron micrograph of spores of Ames strain of B. anthracis from CDC/Janice Haney Carr.
In a recent BusinessWeek article, writer Arlene Weintraub demonstrates a very poor understanding of the differences between outright pharma marketing and the current status of industry-funded, certified continuing medical education (CME). Several online comments to the article, which features the usual high dudgeon of CME critic Daniel Carlat, rightly indicate that Weintraub describes a dated version of industry-funded medical education. For example, MCM's Lew Pinsker wrote,
It's unfortunate that a reporter for a major business periodical would indict a billion-dollar industry without doing due journalistic diligence in researching her subject. As has been pointed out in previous comments, her use of the term "marketing companies" when describing accredited medical education companies ignores the significant changes which have been taking place for more than a year. Organizations which develop certified CME cannot in any way be "marketing companies".
In her article, Weintraub cites two companies, Pfizer and Zimmer Holdings, as having recently suspended their funding of CME produced by medical education communications companies (MECCs). In fact, Zimmer—an orthopedic device company—suspended funding of all CME activity, Weintraub reports, and will identify an "independent third party," like a professional medical society, to produce the CME activities that the company supports financially.
However, Weintraub fails to note that Zimmer's move away from funding CME is likely related to fallout from a Deferred Prosecution Agreement in September of last year with the US Attorney's Office in New Jersey. The Indiana company settled with federal prosecutors as a result of an investigation into the company's financial relationships with consulting orthopedic surgeons. As part of the agreement, Zimmer will pay a civil fine of $169.5 million* and agreed to an 18-month oversight by a federal monitor appointed by the DOJ and a 5-year Corporate Integrity Agreement with the Office of the Inspector General (OIG). The company, however, did not admit to any wrongdoing.
In April of this year, Zimmer announced "comprehensive changes in its corporate compliance model," which "is designed to aggressively reduce potential or perceived conflicts of interest inherent in consulting relationships between industry and healthcare professionals." The changes are intended to "meet and exceed the requirements of its September 2007 resolution agreements with the US government," the company wrote in its press release.
* According to Yahoo, Zimmer's net income for 2007 was $773.2 million.
Adjunctive, transdermal estradiol significantly reduces the positive and general psychopathologic symptoms of acute or chronic schizophrenia in women of childbearing age, according to a clinical study published in this month's Archives of General Psychiatry. The assessment of supplemental estrogen in schizophrenia is based on long-term observations of the delayed onset of disease in women, improved symptoms during pregnancy, and postpartum deterioration.
In the double-blind Australian study, women with acute or chronic schizophrenia (inpatients, 29; outpatients, 73) received randomly assigned transdermal estradiol 100 µg (n = 56) or transdermal placebo (n = 46) for 28 days, in addition to standard psychiatric treatment. Estradiol effects on symptoms were assessed weekly with the standard Positive and Negative Syndrome Scale (PANSS). Despite improved positive symptoms (eg, hallucinations) at 28 days, there was no effect on the negative symptoms (eg, avolition) of schizophrenia.
Larger and longer studies are necessary to confirm these short-term study results and to assess the risk of the known adverse events of estrogen in a population that routinely smokes and is treated with dopamine-blocking antipsychotics. Moreover, stratifying results on the basis of disease state (acute vs chronic) is needed, given the differential effect of short-term estrogen on positive symptoms in this study. Whether estrogen supplementation is worthwhile in men with schizophrenia is a trickier prospect for obvious reasons.
Image of estradiol patch from Mylan.
Our understanding of fear responses in mammals improved last week, thanks to 2 rodent studies published in the latest issue of Nature (see here and here). In a combined analysis of the work, Australian scientists Pankaj Sah and Frederick Westbrook provide an overview of the circuitry now implicated in fear conditioning. Fear conditioning is a process whereby a normally innocuous stimulus (eg, a flashing light) is paired with a noxious, fear-producing stimulus (eg, an electric shock) to produce a fear response after exposure to the innocuous stimulus alone.
The rodent studies indicate that fear conditioning is the result of sensory input from both the innocuous and noxious stimuli into so-called fear neurons of the basolateral portion of the amygdala. (The amygdala is a bilateral, deep-seated collection of neurons within the medial temporal lobes, which can be thought of as the brain's Grand Central Station of emotional reactions.) These fear neurons then activate neurons in another part of the amygdala, the central nucleus, which sends its output to the hippocampus and brainstem to produce a behavioral fear response.
Extinction of the fear response, which occurs after repeated exposure to the innocuous stimulus alone, is the result of activation of intercalated neurons within the amygdala, either directly from the prefrontal cortex or by way of so-called extinction neurons within the basolateral nucleus of the amygdala. These intercalated neurons then inhibit the fear neurons and their input into the central nucleus. Likhtik et al showed that toxic lesions of the intercalated neurons in mice resulted in deficient extinction that correlated inversely with the number of surviving cells.
The renewal of the fear response, which occurs when the innocuous and noxious stimuli are re-paired, is the result of input from the hippocampus, which activates inhibitor neurons in the basolateral amygdala. These inhibitor neurons, in turn, suppress the activity of extinction neurons.
Paj and Westbrook indicate that specific neuronal receptors* within this fear circuitry are likely to become targets for investigational treatments of anxiety and panic disorders in humans.
* The chief transmitter of major inputs into the amygdala is glutamate, and the central nucleus contains inhibitory gamma amino-butyric acid (GABA) receptors, which are potentiated by benzos.
Image of transparent brain from underneath (ventral aspect) showing bilateral amygdalae (red) from Wikipedia.
Get Carter: Michael Caine is smokin' hot as a ruthless hitman who investigates his brother's murder. There's still plenty of England's Swinging Sixties in this 1971 film—micro-minis, sexual promiscuity, bad teeth...no paisley, though.
Poster image from Wikipedia and reproduced under fair use law.
Yesterday, the Massachusetts House and Senate reached anticipated compromises on a widely discussed pharma-code bill, reports the Boston Globe. The drafted bill, which is expected to be approved and sent to the state governor this weekend, now requires the following:
- Companies will report any physician gifts exceeding $50 to the state's Department of Public Health, and the DPH should post this information online for public access.
- The DPH will adopt something like the recently unveiled, voluntary PhRMA code, which bans branded trinkets and out-of-office meals with reps.
- A $5000 fine will be levied for each violation by pharma or medical-device companies.
Two new cases of Tysabri-related progressive multifocal leukoencephalopathy (PML) in patients with multiple sclerosis (MS) were reported yesterday by comarketers Elan and Biogen. In both cases, the diagnosis was established by the detection of JC virus DNA in spinal fluid, along with clinical and MRI findings. The patients had received Tysabri monotherapy for more than a year. These new cases can be added to 2 cases of PML in MS patients who received Tysabri with Avonex (interferon beta-1a; Biogen) and 1 case in a patient with Crohn's disease given Tysabri monotherapy.
Reports of these new PML cases follow the publication in this week's Neurology of the long-term risk-versus-benefit of the agent in patients with relapsing-remitting MS. By assessing quality-adjusted life years (QALYs), investigators from the University of Rochester concluded that the PML risk with Tysabri would have to increase more than 7 times to reduce the drug's net benefit below that of interferon beta. This result is mostly due to the superior reduction of relapses with Tysabri.
|
|
QALYs With Tysabri |
QALYs With |
|
Natural history |
8.70 |
8.70 |
|
Health gains |
|
|
|
Delayed progression |
0.08 |
0.06 |
|
Reduced relapse rate |
0.78 |
0.37 |
|
Health losses |
|
|
|
Non-PML |
–0.002 |
–0.003 |
|
PML |
–0.055 |
0 |
|
Net effect |
9.50 |
9.12 |
The positive analysis notwithstanding, the news of the latest PML cases with Tysabri hit Elan and Biogen hard, with share prices dropping substantially.
