Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Tuesday, September 8, 2015

FDA historically allows fraudulent ads of pharmaceuticals and medical devices targeted to women.


Jeremy A. Greene, M.D., Ph.D., and Elizabeth S. Watkins, Ph.D.
August 19, 2015
Aside from New Zealand, the United States is the only country with a strong pharmaceutical regulatory infrastructure that allows direct-to-consumer advertising (DTCA) of prescription drugs in print, broadcast, and electronic media. U.S. consumers are accustomed to full-page ads in newspapers and magazines detailing a drug's benefits — followed by another page of fine print in which its contraindications, risks, and side effects are spelled out in minute detail and equally minute print.
That may soon change, however, as the Food and Drug Administration (FDA) moves to enact new regulations regarding risk communication in DTCA. Earlier this year, the FDA sought public comments on new guidance for pharmaceutical marketers on communicating risks to consumers in print advertisements. This proposal, which the FDA has kicked around in one form or another since 2004, responds to mounting research showing that reprinting highly technical package inserts in print ads does very little to communicate risks to consumers. The goal is to communicate those risks in a new vernacular.
Instead of reproducing the fine print meant for physicians and pharmacists, the FDA proposes that drug marketers use a new “consumer brief summary” focused “on the most important risk information . . . in a way most likely to be understood by consumers.” A summary written in everyday language might take the form of a Q&A list, for example, or a Drug Facts box like those on packaging for over-the-counter medicines. Drug marketers are being asked to use popular idiom to communicate with people with a wide range of literacy levels; to use larger fonts and more readable formats; and to use visual elements such as white space, logos, and color schemes to highlight the most relevant risks.1
Public comments on the proposal have focused on the challenges of implementation. How many risks are too many to print? How will a manufacturer — or the FDA — know when language is too simple, too technical, or pitched “just right” for average Americans? Missing from this conversation is a broader perspective on the vernacular of risk in pharmaceutical promotion — as something that is not a new DTCA-related duty for the FDA but fundamental to the origins of the category of prescription drugs and their regulation over the past half-century.
After passage of the 1938 Food, Drug, and Cosmetic Act, which established the distinction between prescription-only and over-the-counter drugs, consumers received most information about the latter through ads and most about the former from their physician or pharmacist. Indeed, the category of “prescription-only” medications enabled industry to avoid having to communicate risks directly to consumers in marketing materials. The 1938 law required drugs to carry labels providing “adequate directions for use” and “adequate warnings” to protect users from harm. Partly to sidestep this mandate, drug manufacturers restricted the sale and marketing of their products to doctors, who could comprehend highly technical presentations of indications, contraindications, toxicology, and adverse effects.2
This order of things was upset in the late 1960s, after highly publicized Senate hearings on the safety of oral contraceptives. Women's health activists demanded action after the revelation that knowledge of the health risks associated with the Pill — including potentially fatal pulmonary emboli — had often been kept from women or left for doctors to convey at their discretion. Beginning in 1970, the FDA required manufacturers to include information for patients in every package of birth-control pills. Unlike technical package inserts for pharmacists, this patient package insert (PPI) would outline the health risks of the Pill in clear, everyday prose.

The 1970 Patient Package Insert for Oral Contraceptives.
Yet as the FDA quickly discovered, there was no clear consensus on how best to provide risk information to patients. The first draft of the PPI became a flash point in debates over the relationships between the FDA, drug manufacturers, consumers, and physicians. Entitled “What You Should Know about Birth Control Pills,” the 600-word document described in lay language the health risks, side effects, and contraindications of oral contraceptives. Both the medical profession and the pharmaceutical industry vigorously opposed the proposed pamphlet, and the FDA's parent agency, the Department of Health, Education, and Welfare, advocated revising the wording to address legal issues. In response to pressure from professional, industrial, and government interests, the FDA developed a shorter, less detailed version. The revised text, 100 words long, listed just 5 symptoms of side effects, whereas the earlier draft had listed 25. Gone were statistics on increased risk for and mortality from thromboembolism; the edited version simply mentioned blood-clotting disorders as a possible complication.
During the commenting period on the PPI, the FDA received more than 800 responses, most of them complaining about inadequate disclosure of adverse effects. Yet the insert that finally went to press was even more anemic: it listed no symptoms at all, telling consumers to “notify your doctor if you notice any physical discomfort.” Four of the insert's seven sentences described the availability of an information booklet, which patients could request from physicians. This 800-word booklet, jointly written by the American Medical Association (AMA), the FDA, and the American College of Obstetricians and Gynecologists, provided more information, but very few women actually received it.
It wasn't until 1977, after the FDA mandated use of a PPI to communicate newly disclosed health risks associated with estrogen products, that consumers earned the right to routinely receive the same technical package information as physicians and pharmacists. Then, in 1979, the FDA proposed a lay-language PPI for all prescription drugs. But when physicians, pharmacists, and drug companies balked, the agency scaled back its ambitions to a 3-year pilot program for 10 types of drugs. Even this reduced mandate failed to take effect, after the Reagan administration — seeking deregulation, privatization, and smaller government — required federal agencies to review the necessity and cost-effectiveness of existing and proposed regulations. The FDA deferred implementation of the PPI program in 1981 and canceled it the next year, relying instead on a voluntary private-sector approach.
After the revocation, some written information about prescription drugs was produced by a patchwork of organizations, including the AMA, the U.S. Pharmacopeia, and the American Association of Retired Persons.3 When the FDA began in 1985 to allow drug companies to advertise in mass-market magazines and newspapers so long as they included a “fair balance of information,” as required for ads in medical journals, companies began developing their own “patient information sheets,” which often simply reprinted the text of the package insert written for physicians and pharmacists. This information provision had little to do with educating consumers and much to do with expanding marketing opportunities. The medical terminology, dense verbiage, and tiny fonts of these inserts have made them inscrutable to the average consumer and virtually useless as information sources.4
The FDA's Medication Guide program, proposed in 1995 and launched in 1999, aimed to mitigate this problem for some outpatient prescription products, with user-friendly information to be distributed at the point of sale. The most effective of these guides might serve as templates for risk communication in DTCA. Moreover, in 2015, companies could harness the power of communications technologies such as smartphone-scannable QR codes to link such information to print ads or online materials for interested consumers.
Yet the primary risk-communication challenges the FDA has faced are not technological but social. In the case of the Pill, the PPI's opponents were able to dilute and delay efforts to provide patients with clear, comprehensive risk information. The U.S. medical consumer's voice has grown stronger since the 1970s, and the FDA increasingly relies on social scientific research in its decisions. Nonetheless, the success or failure of the current proposal depends on the agency's ability to capture the interests of all stakeholders.
For all its capacity to encourage overdiagnosis and overmedication, DTCA's virtue is that it treats consumers as people who deserve to know something about the compounds they take into their bodies. After 30 years of DTCA, it's not clear that advertising is the best medium for communicating risk information,5 but marketers should at least be required to try to communicate risk information as effectively as they do their promotional messages.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
This article was published on August 19, 2015, at NEJM.org.
SOURCE INFORMATION

From the Division of General Internal Medicine and the Department of the History of Medicine, Johns Hopkins University School of Medicine, Baltimore (J.A.G.); and the Department of Anthropology, History and Social Medicine, University of California, San Francisco, School of Medicine, San Francisco (E.S.W.).
http://www.nejm.org/doi/full/10.1056/NEJMp1507924#t=article

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