The best recent posts you may have missed

Every other month or so, I post a list of my top 5 favorite posts since the preceding "best of" list on this blog, for those of you who have only recently started reading Common Sense Family Doctor or don't read it regularly. Here are my favorites from the past few months:

1) Changing unhealthy habits requires changing environments (6/4/12)

2) The best colorectal cancer screening test is the one that gets done (5/21/12)

3) The end of the line on PSA screening (7/11/12)

4) How would you rate your health care team? (6/7/12)

5) Making wiser choices about medical tests and treatments (8/2/12)

If you have a personal favorite that isn't on this list, please let me know. Thanks for reading!

The FDA, social media, and Big Pharma - Part 2 of 2

This is the second of two posts that outlines my view of the approach that the FDA should take in regulating pharmaceutical promotion in social media. Part 1 is available here.

**

Another critical element that may determine how involved the industry can be in promoting products through social media outlets is the FDA’s interpretation of manufacturers’ obligations to report prescription adverse events in online discussions that they monitor. The scope of such a task may be more manageable than it seems. In 2008, the Nielsen Company analyzed 500 randomly selected healthcare-related messages on non-pharmaceutical social media sites and found that only one satisfied the FDA’s four standard adverse event reporting requirements (specific medication, adverse experience, identifiable patient, and identifiable reporter). A subsequent analysis estimated that social media generate only 166 reportable adverse events per day across the entire industry, with even the best-selling brand name medications generating fewer than 100 “mentions” each day.

AstraZeneca recently distributed a “white paper” on social media that proposed five principles for guiding the company’s social media activities: ensuring truth and accuracy; respectful participation; protection of patient health; transparency; and tolerance of differing views. It also suggested that in regulating social media activities, the FDA should distinguish between three levels of communications: company-controlled and hosted, such as on company websites; company-controlled communications provided on other websites; real-time communications such as chat rooms and blog comments. AstraZeneca argued that in general, manufacturers should be held most accountable for the first two types of communications and least accountable for the latter.

Ultimately, the FDA’s decision will depend on its assessment of the potential public health benefits and harms of allowing limited or unlimited engagement of pharmaceutical companies in social media for product promotion purposes. As was the case in 1997, when the FDA modified its stance on broadcast DTCA, there is little empiric evidence to indicate that the benefits will necessarily outweigh the harms, or vice versa.

Policy Options

1) Outright Ban – This option would prohibit pharmaceutical companies from using social media for direct product promotion. Companies would be allowed to host and/or support websites that provide news about company activities or general disease information that does not reference particular products.

2) Restrictive Option – Pharmaceutical companies would be permitted to advertise products via social media, but all such activities would be subject to strict FDA oversight and approval, guided by existing regulations regarding “fair balance” in broadcast DTCA. All company communications, on sponsored or independent websites, must be transparent about their source. In addition, companies that chose to engage consumers in conversations about their products would take on the responsibility of monitoring for, and reporting, all adverse events on those websites.

3) Permissive Option – This option would permit pharmaceutical companies to promote their products in any social media outlet without limits, as long as the content provided was factually accurate. “Fair balance” rules would only apply to content posted on company-sponsored websites. Adverse event reporting to the FDA from other websites would be encouraged, but voluntary.

Discussion

The Permissive Option, by continuing the status quo of no explicit FDA regulation of social media, is administratively the most feasible. However, it is likely to have a significant public health impact by encouraging pharmaceutical companies to intensify DTCA of products via social media, increasing requests for (and, probably, prescribing of) promoted medications. The experience of DTCA broadcast ads suggests that health professionals will have mixed responses, and patients will generally support having access to more information about diseases and treatments.

The Outright Ban Option would require a greater investment in administrative resources initially, as many current pharmaceutical industry activities would need to be discontinued to comply with the new policy. In addition, there would be a continuing need to monitor health care social media sites to enforce the blanket restrictions. The public health impact of this option is uncertain, and it may prove unpopular with patients.

The Restrictive Option would require a substantial investment in administrative resources, since it contains the most specific guidance and would require staff to create and apply objective criteria to determine if a specific social media activity is permitted or not (rather than “all are permitted” or “none are permitted”). Although the rationale for regulating product promotions is to encourage social media activities that are likely to benefit the public health and discourage harmful activities, these benefits and harms would be theoretical and initially very subjective. I anticipate that health professionals and patients would be for the most part satisfied with this option. I recommend that the FDA Administrator select the Restrictive Option. Although it poses some administrative challenges, it strikes a balance between too much and too little regulation and is most likely to lead to improvements in public health.

References

1. AstraZeneca. White paper: social media in the pharmaceutical industry. December 2010. Available at: http://www.astrazeneca-us.com/_mshost795281/content/media/AZ_Social_Media_White_Paper.pdf. Accessed February 14, 2011.

2. Davies, M. White paper: listening to consumers in a highly regulated environment: how pharmaceutical manufacturers can leverage consumer-generated media. The Nielsen Company, August 2008. Available at: http://blog.nielsen.com/nielsenwire/wp-content/uploads/2009/11/Nielsen-Online-Healthcare-Practice_Social-Media-Adverse-Event-Reporting_nov09.pdf. Accessed February 14, 2011.

3. Donohoe, J. A history of drug advertising: the evolving roles of consumers and consumer protection. Milbank Quarterly 2006;84:659-99.

4. Frosch DL, Grande D, Tam DM, Kravitz RL. A decade of controversy: balancing policy with evidence in the regulation of prescription drug advertising. Am J Public Health 2010;100:24-32.

5. Greene JA, Kesselheim AS. Pharmaceutical marketing and the new social media. N Engl J Med 2010;363:2087-89.

6. Kravitz RL, Epstein RM, Feldman MD, et al. Influence of patients’ requests for direct-to-consumer advertised antidepressants: a randomized controlled trial. JAMA 2005;293:1995-2002.

7. Kupchuk A, Madagan K. FDA policy on social media and product promotion. Corporate Compliance Insights Blog. Posted June 7, 2010. Available at: http://www.corporatecomplianceinsights.com/2010/fda-policy-social-media-product-promotion/

8. Richman, J. Monitoring adverse events for pharma’s biggest brands: hopeless task or simple project? Dose of Digital Blog. Posted December 8, 2009. Available at: http://www.doseofdigital.com/2009/12/monitoring-adverse-events-social-media-pharmas-biggest-brands/

9. Richman, J. Dose of Digital Pharma and Healthcare Social Media Wiki. Last updated September 10, 2010. Available at: http://www.doseofdigital.com/healthcare-pharma-social-media-wiki/

10. Webb, S. Drug marketing and the new media. Nature Biotechnology 2010;5:396-98.

The FDA, social media, and Big Pharma - Part 1 of 2

Last December, more than two years after first holding public hearings on the promotion of medical drugs and devices via social media, the U.S. Food and Drug Administration finally released draft guidance to pharmaceutical companies on the very narrow topic of responding to unsolicited requests for information on off-label uses of their products. Citing limited resources to explain their glacial progress on this critical guidance, the FDA's website states:

Taking into consideration the input from within and outside FDA, ... we have identified the following issues that are important to address: responding to unsolicited requests; fulfilling regulatory requirements when using tools associated with space limitations; fulfilling post-marketing submission requirements; on-line communications for which manufacturers, packers, or distributors are accountable; use of links on the Internet; and correcting misinformation. We are developing multiple draft guidances to address these topics to benefit industry and the public by ensuring that these draft guidances are meaningful and well thought out when they are issued.

While Big Pharma and other interested observers continue to hold their breath (or not), here is my take on this topic, drawn from a paper I wrote last year. Sources are listed in Part 2 of this post.

**

Direct communication between the pharmaceutical industry and patients is increasingly common. An important milestone in direct-to-consumer advertising (DTCA) was the 1995 FDA hearings, at which pharmaceutical companies requested that the FDA clarify the conditions under which broadcast advertisements need not include a brief summary of benefits and risks from the approved product label. The FDA subsequently stated that these advertisements could instead send consumers to a website, toll-free telephone number, print advertisements, or health professionals for this information. Overall pharmaceutical spending on DTCA then shifted from predominantly print to broadcast advertisements and rose from $1.3 billion in 1998 to $4.9 billion in 2007.

While the pharmaceutical industry has consistently argued that DTCA empowers patients by providing information on potentially undiagnosed health conditions and enabling them to initiate conversations with their physicians about treatments, physicians and physician groups have expressed concerns that DTCA would lead patients to request, and doctors to fulfill, inappropriate prescriptions. Limited evidence on the effect of DTCA on prescribing practices, including a single randomized controlled trial of DTCA for antidepressants suggests that DTCA increases prescribing of advertised medications in general, both for appropriate and inappropriate indications.

A survey conducted by the National Consumers League in 2002 indicated that most consumers did not agree that ads for prescription drugs should be restricted to medical journals. These results may reflect changing societal attitudes about the extent to which patients ought to be involved in making their own health care decisions, and the degree to which health information needs to be filtered through physicians.

Social media websites such as blogs, Facebook, and Twitter differ from static web pages in allowing multiple participants to exchange information, ideas, and opinions in real time. The proliferation of social media tools over the past decade has created new opportunities for unmoderated dialogue between health professionals, pharmaceutical companies, and the public, as well as the rapid dissemination (“going viral”) of health-related content to a broad and diverse audience.

Despite the FDA’s stated intention to issue guidance on permissible uses of social media, the pharmaceutical industry has already established or is involved in many online communities relevant to their products. Some examples of pharmaceutical-sponsored social media websites are a Pfizer-authored blog “forum about science and medicine,” Think Science Now; a GlaxoSmithKline-supported “community” for users of its over-the-counter weight-loss drug Alli; and a Boehringer Ingelheim Facebook page that “is not intended as a forum to discuss technical queries regarding specific pharmaceutical products.” Every major drug manufacturer has an active Twitter account, and most have created one or more mobile phone applications.

Although the FDA’s experience with regulating DTCA can help inform its guidance to the pharmaceutical industry regarding social media, the scope of social media communication is considerably larger than advertising alone. Social media channels are varied, evolving, and for the most part, not under direct industry control. Other unresolved issues include how and where to draw the line between company-sponsored media and “independent” websites, as well as the difficulty in determining financial or other conflicts of interest held by health bloggers, many of whom are anonymous.

As a result of the above concerns, social media activities of the pharmaceutical industry generally have not included DTCA. Only 4% of the $4 billion that the industry spent on DTCA in 2008 on the Internet. Further discouraging online advertising, the industry’s previously-held assumption that fair balance requirements could be satisfied with a “one-click” rule (including a direct link to a web page that contained full risk and benefit information), was overturned when the FDA sent warning letters in April 2009 to 14 companies that had posted brief online ads without risk information on search engines.

Breastfeeding is the infant's best medicine

In honor of World Breastfeeding Week, which ends today, I am re-posting a post I wrote two years ago about breast milk being the "next all-natural blockbuster drug."

**

Pharmaceutical companies and their shareholders are always looking for the next "blockbuster" drug, the label given to a drug that generates more than $1 billion of revenue per year. Blockbuster drugs don't necessarily have to save many (or any) lives - slick marketing more than compensates for marginal improvements in treatment efficacy - but they do need to target conditions that are common enough that millions of patients will buy them. In adults, such conditions include osteoporosis, high cholesterol, and arthritis.

The reason that there have been few, if any, blockbuster drugs for children is that the vast majority of children are healthy. But what if medical science discovered a drug that was proven conclusively to prevent or reduce the risk of a variety of common and uncommon childhood illnesses, including ear infections, gastroenteritis, respiratory infections, eczema, asthma, diabetes, obesity, and even sudden infant death syndrome? A recent cost analysis published in a leading pediatric research journal suggested that giving this drug to 90% of U.S. children for the first 6 months of life could potentially save the lives of more than 900 infants and $13 billion per year. How much do you think people would be willing to pay for this miracle drug? Enough that it could potentially become the first pediatric blockbuster - that is, if breast milk wasn't already free.

Although the American Academy of Pediatrics recommends that mothers exclusively breastfeed infants for the first 6 months of life, and supports continuing breastfeeding to at least one year of age, data from the 2004-2008 National Immunization Survey document that only 73% of U.S. women attempt to breastfeed after birth, and only 42% and 21% are still breasfeeding at 6 and 12 months of life. The numbers are even more discouraging for Black women: only 54% attempt breastfeeding, and just 27% and 11% are still doing so at 6 and 12 months.

Pediatricians and family physicians work diligently to convince women to breastfeed their babies and to continue as long as they can to reap the numerous health benefits (which include a reduced risk of type 2 diabetes, breast, and ovarian cancer for mom), but they are often frustrated in these efforts by health system and employment obstacles. Hospitals commonly distribute free formula or branded diaper bags (my son, who never drank a drop of infant formula, nonetheless went home with a free bag courtesy of Enfamil) and interrupt critical early attempts at breastfeeding with tests and other procedures. Upon returning to the workplace, many moms find that the only private place to pump and store breast milk is a bathroom.

However, a new provision in the health reform bill will for the first time require that U.S. employers (even those with fewer than 50 employees) provide regular breaks and a private space for female employees who need to express breast milk. Small employers who may initially feel that this new requirement is an "undue hardship" should consider the lower health costs (and lower insurance premiums) that should result from more infants consuming this all-natural blockbuster drug.

Making wiser choices about medical tests and treatments

"Sometimes, the hardest thing for a physician to do is nothing," observed my colleague Jay Siwek, MD in a recent editorial in American Family Physician. "And although patients are sometimes a source of excess utilization, physicians, responding to conventional practices, current fads, and the rituals of medicine, often order tests or treatments that don’t stand up to clinical scrutiny. How do we do better? How do we know not only what to do, but also what not to do?"

The editorial compiles family medicine-relevant items from the multi-specialty Choosing Wisely campaign that aims to reduce the provision of "unnecessary" care, defined as medical tests and treatments that offer no health benefits and may result in harm to patients. Based on trusted sources of evidence-based medicine such as the U.S. Preventive Services Task Force, the Cochrane Database of Systematic Reviews, and Essential Evidence Plus, these "don't do" recommendations have the potential to save both lives and money, if they can be effectively put into practice. To inform patients about the campaign, Consumer Reports has created fact sheets about many of the included items.

Reactions to the Choosing Wisely campaign in the blogosphere have been varied. Calling it "the health reform we need," cardiologist John Mandrola writes, "I hope it sticks like super glue." On the other side, emergency physician William Sullivan argues that the campaign "has good intentions, but isn't a good idea," noting that "there isn’t a Suing Wisely campaign for attorneys and there isn’t a Legislating Wisely campaign for Congress." Similarly, family physician Mike Sevilla contends that while Choosing Wisely may "score political points" for sponsoring physician organizations, it is unlikely to change their members' behavior, which is also driven by patient demands and fears of lawsuits over interventions not taken. Where do you stand on this spectrum of opinions? Is the Choosing Wisely campaign good or bad for patients, or perhaps some of both?

**

A slightly different version of this post first appeared on the AFP Community Blog.

Common Sense Family Doctor turns 3: no more baby (or toddler) steps

"What is a year, after all?" I rhetorically asked an audience of Washington DC-area breast cancer care coordinators yesterday during a talk about the limitations of screening mammography. "It's 365 days. There is nothing magic about a yearly screening interval." So, too, is there nothing magic about a blog enduring for a year, or in the case of Common Sense Family Doctor, three years. But it is a convenient milestone worth celebrating in this, my three hundred and seventeenth post. To date, this blog has been viewed more than 172,000 times. My most popular post, an indictment of the deceptive advertising practices of Life Line Screening, has been viewed nearly seven thousand times.

As a father of three children younger than age 7, I can't help but view the passage of time in child years. A few months after my older son was born, I started working at the Agency for Healthcare Research and Quality. I remember rehearsing my first presentation for the U.S. Preventive Services Task Force (a summary of the evidence on screening for COPD using spirometry) in front of my rapt ten-month old, whom I like to think understood the importance of the occasion. Two months after the birth of my daughter, the USPSTF recommended against screening for prostate cancer in men age 75 and older, which appears to have had a significant effect on clinical practice. (The effect of their new recommendation against PSA screening in all men remains to be seen.) By the time my younger son was born this year, I had long since left AHRQ and was preparing to re-enter the world of academia, where I now direct Georgetown University School of Medicine's Fellowship in Primary Care Health Policy.

By the child year standard, then, Common Sense Family Doctor has passed through infancy and toddlerhood, and is now entering what some child-rearing experts call "the wonder years," that amazing period when children achieve a measure of self-sufficiency but remain comfortingly dependent on mom and dad for most of their daily needs. The blog's growth and visibility has been been helped immensely by regular syndication in KevinMD, The Doctor Weighs In, Prepared Patient Forum, and coming soon, Physician's Weekly. It has also given me the opportunity to write for different audiences in Family Health Guide, U.S. News and World Report, and the AFP Community Blog. Many thanks to all of my readers and fellow health bloggers who have provided validation and encouragement along the way.

What can readers of Common Sense Family Doctor expect in the future? More reflections on the proper role of primary care and prevention, now that the Affordable Care Act appears to be here to stay (and prominent Republicans Bill Frist and Mike Leavitt are publicly supporting state-based health insurance exchanges, which I discussed in a previous series of posts). I also intend to write about innovative ways to improve population health outside of health care - a tricky topic, to be sure, and fraught with ethical/political questions about the appropriate role of governments in improving the heath of their citizens (such as putting restrictions on the size of soda containers). No, I don't believe that any government should have the power to force you to buy a gym membership or eat broccoli, and I've always been a skeptic about the value of dietary guidelines. But I consistently favor happy mediums over hardened ideological positions, and hope that this blog will become wiser as it ages. Of course, you will ultimately be the judge of that.