Recently in Media Category
A London pediatrician's diary shows that Haiti desperately needs, more than surgeons, supplies and coordination.
Writing for the Evening Standard, Dr. Nathaniel Segaren of the Caris Foundation, logs his week of guilt, frustration, appall, effort, and anguish among the mayhem. He concludes, "I realise we can be of most help with our knowledge of the city's geography and our ability to speak a combination of French, English and Creole." The ultimate intent becomes to select, with exceptional agony, those patients for transfer to a floating US Navy hospital—which is already beyond capacity.
"There are lots of egos here and mini power struggles," Segaren observes, "People are desperate to claim credit and get maximum media coverage."
From the UN via Flickr: Photo of 18-year-old Haitian girl with head trauma being transported to USS Comfort, a floating hospital.
The latest in potentially cloying medical movies, which I avoid like they're pandemic H1N1, is the newly released Extraordinary Measures, starring the dramatically limited Harrison Ford* and the doughy, but generally likeable, Brendan Fraser. The story, at least on its surface, is reminiscent of 1992's Lorenzo's Oil, in which parents labor valiantly against the rigid medical community (or in the case of EM, the pharmaceutical industry) to find a cure for their children's very rare afflictions.**
Because I'm as likely to see this movie as I am the what-they-show-in-hell Patch Adams, there will be no review based on actual viewing. Instead I rely on the consumer services of critics from major US newspapers.
The reviews, like the movie itself, are more or less predictable. The overarching theme: EM is cable TV, but just with Harrison Ford.
From Michael Phillips of the Chicago Tribune: "[Y]ou can find more provocative medical crises on TV every week of the year, albeit without this film's headliners." "The big confrontations between Fraser and Ford...feel strangely rote...they are, in fact, written and performed at Emmy-highlights-reel pitch." Two stars.
James Verniere of the Boston Herald: "If I had a nickel for every time Ford's craggy-faced, grumpy old man growls 'Get out of my lab' at someone in the film I'd have a dollar." But Verniere calls the cast, especially the supporting actors, "Extraordinary."
Carrie Rickey, Philadelphia Inquirer: "[S]lack, well-meaning disease-of-the-week drama of the sort one might encounter on the Hallmark Channel." Rickey likes Ford (he's "a gas") but finds Fraser "stiff and visibly uncomfortable."
Robert Butler, Miami Herald: "'Measures' is competent enough. However, it's not the least bit inspired...[I]t feels as if it has been carefully assembled not to reveal some truth so much as to push certain dramatic buttons for its audience."
Betsy Sharkey, Los Angeles Times: "[A] sort of uplifting drama that neither touches the heart nor tests the brain—a film that wouldn't make the Showtime...or HBO quality cut." Sharkey says that Ford does a "credible job" but implies that Fraser is out of his league. (And if the league standard is Harrison Ford, for God's sake, change careers.)
A. O. Scott of The New York Times is, perhaps, the most gracious: While he finds a paradox in a "movie about a medical breakthrough" that "is not especially eager to break new ground of its own," Scott says the film delivers an education about the process of medical research. "This is the main reason that 'Extraordinary Measures'...rises above some of its made-for-TV trappings."
* The last and only time I found Harrison Ford interesting in a dramatic role (and it was a bit part) was in The Conversation.
** In Lorenzo's Oil, the disease was adrenoleukodystrophy; in Extraordinary Measures, Pompe disease. The major difference between these 2 stories is that the treatment developed in EM, Myozyme (alglucosidase alfa; Genzyme), is FDA approved.
An earnest-looking Brendan Fraser and a gruff-looking Harrison Ford in a still from Extraordinary Measures.
No. 3: The Transparency Movement Takes a Vice-Like Hold
The push to uncover every potentially relevant tie between physicians and commercial interests, every medical writer behind a figurehead author continued with a vengeance in 2009.
In December, Northwestern University became the latest medical school to voluntarily disclose the financial relationships of its faculty with drug or device companies at its web site. The Chicago-based university joined Stanford, which provided similar online information in August, and the Cleveland Clinic, which boarded the disclosure train last year.
A handful of pharma companies, perhaps in an effort to avoid legislated disclosure,* also committed to posting some of their payments to physicians. This year, Eli Lilly, Merck, and GlaxoSmithKline began revealing various forms of compensation to healthcare professionals for a variety of services, like consulting or speaking. And Pfizer promised to disclose comprehensive data (for instance, meals exceeding $25) beginning in the new year.
Caught up in the spirit of transparency—the Accreditation Council for Continuing Medical Education (ACCME), the US organization that accredits other organizations to provide certified CME—released detailed data on 729 accredited providers in August. In an impressive data dump, the ACCME revealed each provider's accreditation status and whether they received commercial support or income from advertising or exhibits (without, however, disclosing dollar amounts). The vast majority (81%) received some type of commercial support.
Peer-reviewed medical journals published at least 2 press-worthy studies that outlined the prevalence of industry ties among academic physicians (53%) and the incomplete disclosure practices of orthopedic surgeons specifically (nearly 30% of payments, some of which exceeded $1 million). An example of the exhaustive transparency to be expected in medical journals today: the author disclosures in a highly publicized, company-sponsored study in Alzheimer disease consumed roughly 3 columns of small type in the journal Neurology.
In addition to flushing out the financial ties of physician authors, journal editors launched the age of "ghostbusting." The practice and that of honorary authorship (eg, adding the name of a laboratory head to lend cachet or credibility to an article) were found to be relatively common in the most prestigious medical journals, including The New England Journal of Medicine and the Journal of the American Medical Association, according to survey results presented publicly in September.** For offenders whose work is published in PLoS Medicine, the editors recommended immediate article retraction, lifetime banning of the named author, and a report to the author's institution for investigation. Ouch.
Recently Cochrane reviewers became concerned about the actual involvement of listed authors, the possibility of ghostwriting, and the quality of the data from a 2006 analysis of 10 Roche-sponsored trials of oseltamivir (Tamiflu). The drug company received a very public comeuppance from BMJ editor Fiona Godlee this month, for resisting unconditional access to the trial data (see BMJ Editor Bitch Slaps Roche). Godlee concluded that the joint investigation by the Cochrane reviewers, BMJ editors, and a British TV news station "cast doubt not only on the effectiveness and safety of [Tamiflu] but on the system by which drugs are evaluated, regulated, and promoted."
* Either through the proposed Physician Payments Sunshine Act or healthcare reform bills.
** Nosing in on the ghostbusting movement was Senator Chuck Grassley (IA-R), ranking minority member of the Senate Finance Committee. In November, Grassley sent a letter (personally written by the Senator?) to the deans of 10 medical schools, asking them to respond to 6 essay-type questions regarding their schools' policies on ghostwriting and plagiarism.
Another Winter Solstice, another anniversary for the Pathophilia blog. Today marks 2 years of up-and-running blog time, which is 3½ years in Hollywood-marriage time.
And because anniversaries and a closing year prompt reflection, here are Pathophilia's top 10 stories for the year in medicine, pharma, and film noir on DVD. (Ho-ho-ho! So rare that I get to use the blog's strikeout feature as lame joke.)
No. 10: More Dumping on Merck's Vytorin, Zetia
The year began with continued debate (to put it nicely) about how to assess emerging cancer data from clinical trials of the anti-cholesterol combo drug Vytorin (ezetimibe/simvastatin; Merck). (For lots of necessary background, start at last year's No. 6 story.)
In a Smackdown: New England-Style, prominent cardiologist Steven Nissen essentially charged Sir Richard Peto and his colleagues with unethical behavior, when they separately analyzed cancer data from the SEAS trial (which suggested an increased drug-related cancer risk) and data from the ongoing SHARP and IMPROVE-IT studies (which did not). Nissen believed that data from all 3 studies should have been combined for the analysis (which would have affirmed a cancer risk); but Peto, a statistician and epidemiologist, stressed the importance of separating data in a hypothesis-generating study (eg, the SEAS trial) from data in hypothesis-testing studies (eg, SHARP and IMPROVE-IT). His analysis did not indicate an increased cancer risk with the drug.
At the same time, the FDA attempted to quell some of the anti-Vytorin sentiment and downright company-directed schadenfreude caused by the delayed results of 2008's troubled ENHANCE study. (And if you still don't know what the ENHANCE study is, go back to last year's No. 6 story.) The agency emphasized the importance of lowering the LDL cholesterol level (which Vytorin does) to reduce cardiac risks, like MI. The FDA also weighed in on why the ENHANCE study did not show a reduction of another surrogate marker for vascular disease, CIMT, with the addition of ezetimibe to simvastatin. Speculation included the selectiveness of the study population.
Months later, an Abbott-sponsored phase 4 trial (ARBITER 6-HALTS), which pitted the company's Niaspan (extended-release niacin) against Zetia (the ezetimibe half of Vytorin) was terminated early—and not because of safety concerns. The Street speculated that Abbott's drug had outperformed Zetia in the open-label study of high-risk adults. The Street was right.
At the Scientific Sessions of the American Heart Association in November, results of ARBITER 6-HALTS showed that Niaspan outperformed Zetia in 5 of 7 outcomes, including a composite clinical outcome. Many media reports played up Niaspan's effects on CIMT at the expense of Zetia, while downplaying tolerability issues (eg, flushing) and the fact that the study population was small (N = 208) and selective: enrollees were statin-treated adults who had already attained target LDL levels (<100 mg/dL) and had moderately low HDL levels. Niaspan in such patients would be expected to elevate HDL, and Zetia would be expected to further lower total cholesterol and LDL levels—which is what the investigators found.
Relatively minimal attention was given to another small placebo-controlled study of extended-release niacin, also presented at the AHA sessions, in which changes in carotid-wall plaque (via MRI) were comparable in the 2 treatment groups.
Merck's Zetia/Vytorin-related troubles, vis-a-vis 2-plus years of media coverage, were epitomized in an end-of-year article by Forbes reporter Matthew Herper—who showed his continued disdain for the drugs and their marketing in a less-than-objective synopsis of results from relevant clinical trials.
Herper and others like him have 2 more years to capitalize on the controversies surrounding Zetia and Vytorin. At that time, results of the long-running IMPROVE-IT study, in which Vytorin is compared with simvastatin monotherapy in at-risk adults, will be available. The primary and major secondary endpoints in this study aren't surrogate markers, like LDL and CIMT, but actual clinical events.
ARBITER 6-HALTS = ARterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 6 - HDL and LDL Treatment Strategies in Atherosclerosis; CIMT = carotid intima-media thickness; ENHANCE = Effect of Combination Ezetimibe and High-Dose Simvastatin vs Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia; HDL = high-density lipoprotein; IMPROVE-IT = Improved Reduction of Outcomes: Vytorin Efficacy International Trial; LDL = low-density lipoprotein; SEAS = Simvastatin and Ezetimibe in Aortic Stenosis; SHARP = Study of Heart and Renal Protection.
Public-domain image of Hamilton-Burr duel, which admittedly took place in New Jersey (not New England), from Wikipedia.
12/22/09 update: The FDA says it's "unlikely" that Vytorin and Zetia increase the risk of cancer; although the agency can't rule out the possibility, according to today's WSJ. The agency's announcement comes after its own review of cancer data from the SEAS trial.
In the midst of the 2009 pandemic influenza epidemic, BMJ editor Fiona Godlee takes Roche to task for not supplying the necessary data to confirm or refute the benefits of oseltamivir (Tamiflu) in otherwise healthy people with influenza. In one of 2 BMJ editorials, Godlee chides Roche for not supplying unconditional access to raw data from a pooled analysis of 10 company-sponsored trials (Kaiser et al; PubMed link here) to Cochrane reviewers Jefferson et al. Consequently the reviewers were "obliged to disregard" the bulk of these data (8 of the 10 trials) and were unable to verify that oseltamivir prevents lower-respiratory-tract complications (eg, pneumonia) due to influenza.
In their previous 2006 Cochrane review, Jefferson et al had concluded that oseltamivir 150 mg daily prevents such complications on the basis of the Kaiser article. However, the authors were criticized through a public feedback mechanism for using the 10-trial analysis without having access to the raw data. Prompted by this criticism, Jefferson et al then conducted another review, published this week in the BMJ, in which they affirmed their critic's perspective:
Data on the effectiveness of oseltamivir against complications of influenza principally came from one study...This was a meta-analysis of 10 trials containing a mixture of published and unpublished data, two of which are reported in this update and the remainder inaccessible to proper scrutiny, so that we are now obliged to disregard them. The remaining data showed no benefit for oseltamivir against complications.
In her editorial, Godlee asks, "Where does this leave oseltamivir, on which governments around the world have spent billions of pounds?" She, moreover, emphasizes that the Cochrane review data apply only to healthy adults with influenza, but they "say nothing about [oseltamivir's] use in patients judged to be at high risk of complications—pregnant women, children under 5, and those with underlying medical conditions." Even the drug's ability to reduce influenza-related symptoms (which Jefferson et al reconfirmed) are doubted, because there are no head-to-head studies with oseltamivir and NSAIDs, for instance.
In another BMJ editorial (with Cochrane director Mike Clarke), Godlee concludes that the latest Cochrane review and a "linked investigation undertaken jointly by the BMJ and Channel 4 News cast doubt not only on the effectiveness and safety of oseltamivir (Tamiflu) but on the system by which drugs are evaluated, regulated, and promoted." In their investigation, Cochrane reviewers became concerned about the actual involvement of listed authors on the Kaiser analysis, the possibility of ghostwriting, the high rates of influenza in the trials, and the low rates of serious adverse events.
Initial responses from Roche employees, who first declined to provide the data and then offered selected files, were less than satisfactory to the reviewers. The latest response from the company: it is "committed to making the 'full study reports' available on a password protected site soon."
On the basis of this experience, Godlee and Clarke conclude that the current system for reporting drug research "isn't working" and offer a number of potential remedies—including government-mandated access to raw data that are used to license and market a drug (eg, something in the spirit of the FDA Amendments Act of 2007).
News sources are all over this story (eg, Bloomberg), and the BMJ offers full-text access to the following relevant articles, including a response from a Roche employee—who chastises Jefferson et al for enlisting the investigative help of a TV news station.**
- Godlee F. We want raw data, now.
- Godlee F, Clarke M. Why don't we have all the evidence on oseltamivir?
- Smith J, on behalf of Roche. Roche replies to the authors of the Cochrane Review on oseltamivir.
- Cohen D. Complications: tracking down the data on oseltamivir.
- Doshi P. Neuraminidase inhibitors--the story behind the Cochrane review.
- Freemantle N, Calvert M. What can we learn from observational studies of oseltamivir to treat influenza in healthy adults?
- Jefferson T, Jones M, Doshi P, Del Mar C. Neuraminidase inhibitors for preventing and treating influenza in healthy adults: systematic review and meta-analysis.
- Web extra (including the criticism that got the ball rolling).
* And I mean that in the nicest possible way.
** Roche's Smith writes, "It is unclear to us why Dr Jefferson would adopt this approach, particularly given that he was a paid ad hoc consultant to Roche working on flu and oseltamivir between 1997 and 1999. During that period he worked closely with Roche experts, many of whom are still in the company, and he would therefore not have had difficulty in contacting them directly to discuss his requirements."
Photo from Vermin Inc at Flickr.
For what it's worth (perhaps a teeny-tiny indicator of an economic rebound?), pharma's spending on direct-to-consumer (DTC) advertising increased substantially during the third quarter of this year, to about $1.26 billion according to data from TNS Media Intelligence.* Numbers provided directly by the "intelligence" firm indicate that pharma's investment in DTC advertising increased by nearly 16% during July-September of 2009, when compared with DTC expenditures during the same time last year.
The following figures from TNS show that the latest quarterly increase in pharma's DTC ad spend has stabilized the declining trend in DTC investment for the year. (According to the latest data from the Congressional Budget Office, DTC expenditures by pharma totaled $4.7 billion in 2008—which has declined from a peak of $5.4 billion in 2006.)
|
Time Period |
DTC Spend, 2008 |
DTC Spend, 2009 |
Change |
|
Q1-Q2 |
$2,373,589,000 |
$2,221,822,000 |
–6.4% |
|
Q1-Q3 |
$3,462,700,000 |
$3,483,600,000 |
+0.6% |
|
Q3 |
$1,089,111,000 |
$1,261,778,000 |
+15.9% |
Television advertising still gets the biggest share of the DTC pie, about 65% of the outlay, according to the data; although investment in TV prescription drug ads dropped slightly (by 3.9%) during the first 2 quarters of 2009. Spending on Internet-based drug advertising (ie, banner ads) increased dramatically during the first half of the year, from about $36 million in 2008 to roughly $116 million (an increase of >200%).
|
Media |
DTC Spend, Q1-Q2 2008 (Thousands) |
% |
DTC Spend, Q1-Q2 2009 (Thousands) |
% |
Year-to-Year Change |
|
TV |
$1,524,602 |
64.2 |
$1,465,068 |
65.9 |
–3.9% |
|
Magazine |
$738,326 |
31.1 |
$583,217 |
26.2 |
–21.0% |
|
Newspaper |
$66,833 |
2.8 |
$44,980 |
2.0 |
–32.7% |
|
Internet |
$35,945 |
1.5 |
$116,178 |
5.2 |
+223.2% |
|
Radio |
$6002 |
0.3 |
$11,208 |
0.5 |
+86.7% |
|
Outdoor |
$1881 |
0.1 |
$1173 |
0.1 |
–37.6% |
|
Total |
$2,373,589 |
100.0 |
$2,221,824 |
100.0 |
–6.4% |
DTC Perspectives,* also referencing data from TNS Media Intelligence, indicates that spending on Internet-based ads more than tripled during the first 9 months of 2009, to $221 million.
Money spent advertising the top 10 promoted drugs to consumers accounted for nearly 40% of DTC expenditures during the first half of 2009. Again, these data are provided directly by TNS Media Intelligence.
|
Brand Name Drug (Company) |
DTC Spend, Q1-Q2 2008 (Thousands) |
DTC Spend, Q1-Q2 2009 (Thousands) |
|
Lipitor (Pfizer) |
$28,066 |
$117,014 |
|
Abilify (BMS/Otsuka) |
$53,557 |
$114,506 |
|
Cymbalta (Lilly) |
$84,527 |
$93,004 |
|
Advair (GSK) |
$93,643 |
$87,390 |
|
Plavix (BMS/sanofi) |
$94,952 |
$81,585 |
|
Ambien (sanofi-aventis) |
$79,808 |
$79,458 |
|
Lyrica (Pfizer) |
$87,436 |
$75,734 |
|
Cialis (Lilly) |
$65,750 |
$70,660 |
|
Singulair (Merck) |
$51,284 |
$70,628 |
|
Crestor (AstraZeneca) |
$62,135 |
$68,739 |
|
Total |
$701,158 |
$858,718 |
|
Percentage of DTC $ |
29.5% |
38.6% |
* DTC Perspectives, citing TNS Media Intelligence, indicated that pharma's DTC spending for Q3 of 2009 was about $1.16 billion, which is $100 million off from my calculation. DTC Perspectives Q3 calculation was requoted by Pharmalot.
Never missing an opportunity to engage in a Zetia (aka ezetimibe) pile-on, Forbes reporter Matthew Herper shows his continued disdain for the drug and its marketing in his most lopsided article yet. Herper's less-than-objective synopsis of Merck's Zetia-related troubles follows results of a recent, small head-to-head study, in which Abbott's Niaspan (extended-release niacin) outperformed Zetia in a highly selected population.
The essential problem with Herper's (and others') coverage of Zetia: He fails to stress that the drug significantly lowers LDL cholesterol—a well-recognized risk factor for vascular disease and a primary target of prevention guidelines. Herper is correct in writing, "No trials show that [Zetia] prevents heart attacks"; but he neglects to remind his readers that, at one time, the same could have been said of Pfizer's blockbuster statin Lipitor (atorvastatin).
Lipitor came to market in 1996 because it significantly lowered LDL-C; but Lipitor had not yet been shown to prevent clinical vascular events like other statins. Nevertheless, Lipitor quickly became the number-one statin because 1) it reduced LDL-C by a relatively greater percentage than other statins and 2) clinicians believe that the LDL-C level is directly related to the risk of vascular events. Lipitor wasn't approved to reduce the risk of vascular events until 2004.
Herper claims, "Merck's clever marketers have spun straw into gold"—a metaphor that wrongly equates the lowering of the LDL-C level with worthless "straw." To support his claim, he cites results of the Niaspan study and the infamous ENHANCE study, both of which enrolled highly selective at-risk populations and used another surrogate marker for vascular disease—the ultrasound measurement of carotid intima media thickness (CIMT). Merck (and Schering-Plough) reportedly struggled with the quality of the CIMT measurements in the ENHANCE study, and some investigators have questioned the usefulness of CIMT generally to assess cholesterol-lowering drugs. For instance, in the placebo-controlled CASHMERE trial, Lipitor failed to significantly alter CIMT in postmenopausal women, despite that fact that the statin undeniably reduces the risk of cardiac events and stroke.
Herper adds Zetia-disparaging quotes from prominent cardiologists, like Sanjay Kaul (who described Zetia as "the miracle of marketing, not the miracle of medicine") and renowned Zetia/Vytorin basher Steve Nissen ("We've spent billions on a drug that may turn out to be a placebo.") Herper also implicitly chastises Merck for waiting 3 years after Zetia approval (in 2002) to begin the IMPROVE-IT study, in which Vytorin (the combination of ezetimibe and simvastatin) is being compared with simvastatin alone to reduce the risk of a composite vascular outcome. Vytorin was FDA approved in 2004.
Herper also unfairly casts aspersions at prominent cardiologists Michael H. Davidson and Antonio M. Gotto, Jr, for providing "lecture and consulting" services to Merck after the results of the ENHANCE study became public. Herper implies that these physicians were paid off to promote the drug, despite the fact that the small and troubled ENHANCE study failed to show the benefit of adding Zetia to statin therapy in a highly select group of patients (ie, individuals with familial hypercholesterolemia). Herper's information was evidently supplied by the office of Senator Grassley, ranking minority member of the Senate Finance Committee.
A quick examination of the medical literature reveals that both physicians (like so many others) endorse the vascular benefits of lowering the LDL-C level. For instance, in a recent editorial, Gotto writes, "Lowering elevated [LDL-C] is a surefire way to reduce cardiovascular risk." But he also acknowledges the potential drawbacks of using surrogate markers to assess the protective benefits of drugs by adding, "As monotherapy, [Zetia] at 10 mg reduces LDL-C by approximately 17%, but when added to any dose of statin, it reduces LDL-C by an additional 25%. Given the well-established log-linear relationship between LDL-C and relative risk for [coronary heart disease], these greater degrees of LDL-C reduction can be expected to result in improved clinical outcomes, although this has not yet been proven in the case of ezetimibe."
In another editorial ("Is LDL-C passed its prime?"), Davidson more clearly lays out the shortcomings of applying general guidelines to what is probably a very heterogenous at-risk population. He notes that the rising number of patients with metabolic syndrome and those currently taking statins present more complex portraits of dyslipidemia and its associated vascular risks. He argues that, in these subgroups, other lipid markers—like apoB, LDL-particle number, and non-HDL levels—become relatively more predictive of coronary heart disease. Consequently drugs that specifically affect these levels (for example, niacin) may be more protective in these specific populations.
CASHMERE = Carotid Atorvastatin Study in Hyperlipidemic Postmenopausal Women; ENHANCE = Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression; IMPROVE-IT = Improved Reduction of Outcomes: Vytorin Efficacy International Trial; LDL = low-density lipoprotein.
The dramatic "Inside Edition" video can be found here; but any neurologist worth his or her salt would recognize that the young woman's filmed condition is factitious. I fully suspect that the Hopkins neurologists who reportedly made the diagnosis of "dystonia" believe that it represents a profound case of malingering also.
Jennings claims that her movement disorder appeared 10 days after getting a seasonal flu shot in August—so the obvious secondary gains would appear to be attention and financial compensation.
Other bloggers, like Orac and neurologist Steve Novella, have commented extensively on this case.
For the record, Jennings appears to have recovered with questionable treatments from the questionable Rashid Buttar, a controversial osteopath in North Carolina. God knows, she couldn't have kept it going forever.
11/24/09 update
Two Losers Find Each Other Thanks to a Third Loser
Jenny McCarthy's Generation Rescue evidently recommended Buttar to Desiree Jennings, the Washington Redskins cheerleader ambassador (whatever the hell that is). According to this recent Fox News affiliate report (which, once again, demonstrates that local news reporting simply sucks), Buttar diagnosed Jennings with something he calls "acute viral postimmunization encephalopathy" and "secondary mercury toxicity"—both of which he attributes to the flu shot.
But if Jenning's vaccination delivered any mercury,* she would have received no more than 25 micrograms of ethylmercury in the form of the preservative thimerosal.
And all injected seasonal flu vaccines contain inactivated (ie, split) virus, which is incapable of causing infection.
* And if the vaccine was in the form of a single-use syringe, it did not have ethylmercury-containing thimerosal.
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.
Forever brainstorming, Google is now helping Americans find a flu shot (either against seasonal or pandemic influenza) through the company's beloved Maps feature. The new tool (found here) is the product of a collaboration between Google and the US DHSS, the CDC (flu.gov), and the American Lung Assocation.
For example, here's where residents of the White House can possibly get a seasonal (blue) or pandemic (red) flu shot. (To the left of the map would be a list of the locations, ordered by proximity to the entered address and labeled "A" through whatever.)
Keep in mind that the Goggle tool is in its beta stages: locations for many flu shot clinics may be missing, the company advises, and locations currently listed may be out of stock. Nevertheless, it's a starting point for consumers.
For more information about the tool's development, go here.
HT: Mashable by way of attentionusa.com.
