Marketing: June 2008 Archives
In an ongoing effort to protect consumers from fraudulent cancer treatments, the FDA sent warning letters to 25 web-based businesses from April 17 to June 9. The warned companies or entities and a list of their 125 "fake cancer 'cure' products" were posted yesterday at the FDA web site. These letters follow a series of warning letters sent by the FTC earlier this year to 112 web sites, which falsely promoted cancer treatments, says the FDA. Consumer complaints and a web search performed by the FDA, FTC, and members of the Mexico-US-Canada Health Fraud Working Group prompted the overdue crackdown.
At least 3 of the targeted entities are already known to the FDA. A search of warning letters at Casewatch indicates that Vitasalus Inc (Nu-Gen Nutrition), Vitapurity, and H&L Worldwide all received earlier letters from the FDA, which claimed that the businesses promoted products for the "cure, mitigation, treatment, or prevention of diseases" in violation of the Federal Food, Drug, and Cosmetic Act. These repeat warnings do not necessarily include the numerous instances in which companies have fraudulently hawked the same products—for example, "Coral Calcium" or "Curcumin"—in rotating fashion as disease treatments.
An FDA warning letter sent to Vitasalus (Nu-Gen Nutrition) in May 2002 cited a single website, cancerchoices.com, and the product Squalamax. However, the most recent FDA letter cites 7 websites and 6 other products, in addition to Squalamax. A Wayback search reveals that 6 of the 7 Vitasalus websites named this year existed in 2002. The 2 other companies, H&L Worldwide (Chang Li) and Vitapurity (Otto Roder), have evidently not moved their cyber or land-based addresses since the time of their FDA warning letters in 2004 and 2005, respectively. Given the number of products promoted by each company and those cited by the FDA this year, business does not seem to have suffered for either company in the interim.
Leaders of the Energy and Commerce committee, John Dingell (D-MI) and Bart Stupak (D-MI), requested that 4 drug companies adhere to rules for direct-to-consumer (DTC) ads that are mostly already in place. The letters were sent May 20 to leaders at JNJ, Pfizer, Merck, and Schering-Plough following a May 8 congressional hearing, "Direct-to-Consumer Advertising: Marketing, Education, or Deception?" Responses to the representatives' letters were posted yesterday at the committee's website.
Today's media coverage largely focuses on the representatives' request for a voluntary, 2-year moratorium on DTC advertising of new drug products, which was declined by the companies. However, Dingell and Stupak made other requests, as described in sequence here:
- That the companies follow the AMA's guidelines for the use of actors and health professionals in DTC ads.
The AMA's policy H-105.988 states that "product-specific DTC advertisements should not use an actor to portray a health care professional...because this portrayal may be misleading and deceptive. If actors portray health care professionals in DTC advertisements, a disclaimer should be prominently displayed." Also "[t]he use of actual health care professionals, either practicing or retired, in DTC to endorse a specific drug or implantable medical device product is discouraged but if utilized, the advertisement must include a clearly visible disclaimer that the health care professional is compensated for endorsement."
The representatives' request is, no doubt, a response to Pfizer's semi-controversial use of artificial-heart inventor Robert Jarvik to promote Lipitor in its now-pulled DTC ads. Pfizer replied to the committee that it is "currently working internally to ensure that the recent AMA guidelines...are fully incorporated into our DTC advertising when applicable." Merck responded that none of its current DTC ads use physicians or actors who play physicians. All companies, including JNJ and Schering-Plough, agreed to comply with the AMA policy in cases where it might be relevant.
2. That DTC ads not market products until a "valid outcomes study" is completed, and the results are released.
The representatives' definition of valid outcomes is not entirely clear; although they may be referring to longer-term clinical outcomes—for example, cardiac events instead of surrogate cholesterol levels in the case of cholesterol-lowering medications (ie, statins). Certainly DTC ads can only promote the use of FDA-approved pharmaceuticals, which must show at least clinically meaningful efficacy and safety to be approved. JNJ wrote that it has concerns about categorically prohibiting DTC ads "before completion of studies of an undetermined time and nature." Merck indicated that it would defer to the FDA on this point. Pfizer and Schering-Plough (which market Lipitor and Vytorin, respectively) indicated that waiting for long-term clinical outcomes would compromise consumer education and, therefore, consumer health.
3. As recommended by the Institute of Medicine, that there be a 2-year (instead of the conventional 6-month) moratorium on DTC ads for new prescription drug products.
In 2006, the IOM recommended that the FDA require a special product label to identify a new drug or new drug combination, and that DTC advertising should be restricted during 2 years. The FDA has not implemented the IOM's recommendation. All companies contacted by the representatives indicated that they abide by a general, internal 6-month moratorium on DTC advertising and would continue to do so. The companies cite PhRMA guidelines, which state that "companies should spend an appropriate amount of time to educate health professionals...before commencing the first DTC advertising campaign...[C]ompanies should take into account the relative importance of informing patients of the availability of a new medicine, the complexity of the risk-benefit profile of that new medicine and health care professionals' knowledge of the condition being treated."
4. That DTC drug ads should not market off-label uses.
Probably the most blatant example of grandstanding by the congressmen. Of course, DTC advertising must comply with FDA-approved labeling, and all companies indicated their compliance.
5. That DTC ads include the FDA's toll-free MedWatch phone number for reporting adverse events.
Current law mandates the listing of the MedWatch number in DTC print ads, and a toll-free information number in televised ads. JNJ indicated that it would include the MedWatch number in its TV ads. The other companies stated that they would defer to the FDA, pending the agency's ongoing investigation of this particular matter.
6. That so-called black-box warnings be included in DTC ads.
Merck and Schering-Plough indicated that they did not have any DTC ads for products with black-box warnings, and all companies replied that they have deferred (ie, Pfizer) or would defer to the FDA about how to incorporate such safety information into DTC ads.
HT for story: Pharmalot.
In an expected move, representatives of the primary voting blocks of the AMA House of Delegates—primary care doctors, state medical societies, and specialty medical societies—strongly objected to an AMA proposal to eliminate commercially supported CME, according to today's Medical Marketing & Media. The AMA's Council on Ethical and Judicial Affairs (CEJA) had recommended the phasing out of nearly all commercial support for CME, an issue which was debated at a committee hearing on Sunday, during the annual meeting of the AMA House of Delegates in Chicago.
John Kamp, executive director of the Coalition for Healthcare Communication, reported that the proposal "went down in flames," according to the paper. The CHC, along with the North American Association of Medical Education and Communication Companies (NAAMECC), objected to the CEJA proposal on the basis of 3 general arguments:
[T]he report ignores the dramatic difference between certified CME and other non-certified 'education' and thus overlooks the significant advances in the management and resolution of conflicts of interest mandated in the last several years by government, industry and the [ACCME].
[T]he report's conclusions are not based on current and scientifically relevant and rigorous evidence in the context of certified CME and do not respect dramatic progress in the past decade.
[T]he report lacks a plausible, detailed plan to ensure that the proposed elimination of $1 billion in certified CME funding would improve the quality of certified CME and patient care.
Given the objections voiced at the AMA meeting, the CEJA proposal is "referred back to the council, effectively tabling it for the year," wrote the paper.
