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random rants about news, the law, healthcare law, economics and anything I find amusing

Effect of Exposure to Small Pharmaceutical Promotional Items on Treatment Preferences, May 11, 2009, Grande et al. 169 (9): 887

A new study finds that subtle exposure to branded pharmaceutical items, even without the social interactions of gifting, influence medical school student attitudes towards brands.  The study has some interesting discussion regarding “boomerang” response by some of the students from the institution that had strong rules prohibiting gifts.  This reaction may have some bearing on current efforts to ban gifts and marketing materials at healthcare institutions as well as the so-called “Sunshine Laws” at the federal and state levels regarding transparency of pharma and medical device marketing and financial arrangements, including gifting.

From the study’s commentary:

Our study finds that subtle exposures to branded pharmaceutical promotional items influences implicit attitudes of medical students toward pharmaceutical brands. The observed effect was modified by training year and school. Among third-year medical students, no significant experimental effects were observed. However, among fourth-year medical students there were significant effects at both schools in our study. Students at Miami responded as we hypothesized, shifting their preferences in the direction of the branding exposure (ie, Lipitor). However, students at Penn had a boomerang response, ie, a behavioral response opposite of the implied marketing intent.22 The most likely explanation for the difference across class year is that, as students advance in their training, they begin to form attitudes toward various treatment options that can be primed with branded promotional items. In comparison to third-year students, fourth-year students have had greater clinical experience and greater exposure to their clinical teachers and prevailing institutional practices.

The divergent effects at our 2 study schools are an interesting finding. At Penn, exposure to the branded items produced less favorable implicit attitudes. One potential explanation for this effect is that the strong school policy provided an external warning about specific persuasion tactics underlying pharmaceutical marketing. This information may have motivated some form of resistance by the audience23 that could have taken the form of simple message rejection or active counterarguing or careful message scrutiny.24 The policy therefore may have heightened the ability of the Penn students to exercise what has been termed “persuasion coping effectiveness”,25 which produces a goal within oneself to achieve one’s own current learning or attitudinal goal independently of what the marketer seems to be trying to accomplish. The differential attitudes observed in the marketing survey, with the Penn students exhibiting significantly more negative attitudes than those in the national sample or for the Miami students where no policy exists, support this explanation. At Miami, where students had more positive attitudes toward marketing, exposure to a branded promotional item likely primed more positive implicit associations.

via Arch Intern Med — Effect of Exposure to Small Pharmaceutical Promotional Items on Treatment Preferences, May 11, 2009, Grande et al. 169 (9): 887.

Filed under: Conflicts of Interest, Health Law, , , ,

Sunshine in Vermont… Again. Vermont Senate Bill (S-048)

As reported in the NY Times Blog yesterday, the State of Vermont, which already had fairly strict provider financial arrangement reporting requirements for pharmaceutical companies doing business in the state, is slated to significantly limit gifts to providers by both pharmaceutical and medical device companies.  The new law, which, according to the NYT blog, will be signed by the governor, will prohibit all but certain enumerated gifts, revise reporting requirements by pharmaceutical companies and expand the reporting requirements to medical device manufactures.

The legislative bodies findings and intent, obviously influenced by the reporting thus far provided under the previous version of the law, outline its concerns, stating its belief that marketing practices can influence the rise in health care spending and that “state of Vermont has a substantial interest in cost containment and the protection of public health.” The legislature cites a number of findings leading to its adoption of the legislation:  (i) an IOM study linking gifts to prescribing behavior, (ii) recent federal crackdowns on medical device manufacturers’ alleged antikickback  violations (see my related post on the federal Sunshine Act), (iii) significant spending in the relatively small state of Vermont on pharma marketing (“[i]n fiscal year 2008, pharmaceutical manufacturers reported spending $2,935,248.00 in Vermont on fees, travel expenses, and other direct payments to Vermont physicians, hospitals, universities, and others”), (iv) the pharma industry’s focus on 100 physician opinion leaders for almost two-thirds of pharma’s spend (“approximately $2.1 million in payments went to physicians…[with the] top 100 individual recipients received nearly $1,770,000.00 in fiscal year 2008”) and prevalence of pharma’s spend throughout Vermont’s 4,573 licensed health care professionals, with 2,280 being recipients.   Based upon the legislation, the Vermont lawmakers certainly are frowning on the nearly $1M spent on food, noting that many food recipients received $1,000 or more spent on them.  One individual recipient, in fact, apparently receive over $15,000 in food.

The legislature concludes that the “act is necessary to increase transparency for consumers by requiring disclosure of allowable expenditures and gifts to health care providers and facilities providing health care [in order] to reduce real or perceived conflicts of interest which undermine patient confidence in health care providers and increase health care costs by influencing prescribing patterns.  Limitations on gifts and increased transparency are expected to save money for consumers, businesses, and the state by reducing the promotion of expensive prescription drugs, biological products, and medical devices, and to protect public health by reducing sales-oriented information to prescribers.”

The new law prohibits “any manufacturer of a prescribed product or any wholesale distributor of medical devices, or any agent thereof, to offer or give any gift to a health care provider.”  It provides that the  attorney general “may bring an action in Washington superior court for injunctive relief, costs, and attorney’s fees and may impose on a manufacturer that violates this section a civil penalty of no more than $10,000.00 per violation. Each unlawful gift shall constitute a separate violation.”

Permitted items that are not deemed prohibited gifts include:  (i) samples, (ii) limited short term evaluation use loaners of medical devices not exceeding 90 days, (iii) reasonable quantities of medical device demonstration or evaluation units to a health care provider to assess the appropriate use and function of the product, (iv) provision, distribution, dissemination, or receipt of peer-reviewed academic, scientific, or clinical articles or journals and other items that serve a genuine educational function, (v) scholarship or other support for medical students, residents, and fellows to attend a significant educational, scientific, or policy-making conference or seminar of a national, regional, or specialty medical or other professional association if the recipient of the scholarship or other support is selected by the association, (vi) rebates and discounts for prescribed products provided in the normal course of business.  Certain items are not prohibited and are considered “allowable expenditures.”  These include (i) certain limited sponsorship of a significant educational, medical, scientific, or policy-making conference or seminar, (ii) certain limited honoraria and payment of the expenses of a health care professional who serves on the faculty at a bona fide significant educational, medical, scientific, or policy-making conference or seminar, (iii) bona fide clinical trial arrangements, (vi) certain limited bona fide research projects, (v) expenses relating to technical training of individual health care professionals on the use of a medical device pursuant to a written agreement.

Manufactuers need to report “any allowable expenditure or gift … to any health care provider” or “to an academic institution or to a professional, educational, or patient organization representing or serving health care providers or consumers” in the following categories:

  • “The loan of a medical device for a short-term trial period, not to exceed 90 days, to permit evaluation of a medical device by a health care provider or patient.”
  • “The provision of reasonable quantities of medical device demonstration or evaluation units to a health care provider to assess the appropriate use and function of the product and determine whether and when to use or recommend the product in the future.”
  • “The provision, distribution, dissemination, or receipt of peer-reviewed academic, scientific, or clinical articles or journals and other items that serve a genuine educational function provided to a health care provider for the benefit of patients.”
  • “Scholarship or other support for medical students, residents, and fellows to attend a significant educational, scientific, or policy-making conference or seminar of a national, regional, or specialty medical or other professional association if the recipient of the scholarship or other support is selected by the association.”
  • “Labels approved by the federal Food and Drug Administration for prescribed products.”

Manufacturers must report, on form specified by the attorney general, the value, nature, and purpose of each allowable expenditure, and permitted gift along with (i) the name of the recipient, (ii) the recipient’s address, (iii) the recipient’s institutional affiliation, (iv) prescribed product or products being marketed, if any; and (v) the recipient’s state board number.

Failure to manufacturer of prescribed products that fails to disclose as required by the law subjects the manufacturer to a civil penalty of no more than $10,000.00 per violation. Each unlawful failure to disclose, however, constitutes a separate violation.

The legislation also directs the attorney general’s office to conduct a review, in consultation with the commission on health care reform, of the advisability of modifying the law to require the disclosure of information about the provision of pharmaceutical samples to health care providers.   At present, samples are expressly excluded from the reporting regime.

If signed into law, the law will take effect July 1, 2009, but reporting activities under new regime will be implemented in 2010 reporting period.

Clearly the legislature had cost on its mind in enacting the law, as it also has tasked a state workgroup to explore generic alternative formularie recommendationss.   The workgroup is to report to the legislature by January 15, 2010 on the list generated.

Filed under: AKS, Conflicts of Interest, Health Law, , , , ,

AMNews: March 23, 2009. Doctors increasingly close doors to drug reps, while pharma cuts ranks … American Medical News

In the March 23, 2009 AMA News, a consulting firm reports that the heyday of the pharma detailer may have already peaked and is headed into decline:  “At its peak in 2007, the American pharmaceutical industry fielded 102,000 sales reps, said Chris Wright, managing principal for the consulting firm ZS Associates’ U.S. Pharmaceuticals Practice. Drugmakers have slashed the number to 92,000 since then, and ZS projects the number will fall to 75,000 by 2012 at the latest, saving the industry $3.6 billion.”

According the article and the survey, fewer physicians are spending less time with the detailers.  More types of providers are requiring advance appointments.

The article and survey reports that “[p]hysicians’ openness toward visits by pharmaceutical company detailers varies by practice ownership and size.

Refuse
to see
Require
appointments
Practice size
1 to 2 doctors 14.3% 32.5%
3 to 5 16.7% 36.1%
6 to 10 23.1% 45.0%
More than 10 44.0% 45.5%
Practice ownership
Non-hospital 22.1% 37.8%
Non-health system 22.3% 37.5%
Hospital 31.2% 44.6%
Health system 34.7% 52.0%

Source: “Physician Access: U.S. Physicians’ Availability to See Drug and Device Sales Reps,” SK&A Information Services Inc., released February”

The article also reports significant decreases in detailing staff.  “Experts estimate the U.S. pharmaceutical sales rep force eventually will be cut 25% from its 2007 peak of more than 100,000. Here are some of the biggest layoffs announced in the last year.

Drugmaker Sales rep cuts
GlaxoSmithKline plc 1,800
Merck & Co. Inc. 1,200
Wyeth 1,200
Schering-Plough Corp. 1,000
Sanofi-Aventis 650

Source: News accounts”

via AMNews: March 23, 2009. Doctors increasingly close doors to drug reps, while pharma cuts ranks … American Medical News.

Filed under: Conflicts of Interest, Health Law, , , , , ,

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