Welcome to the July issue

Welcome to the July issue of HOC. In it, you'll find part 2 of Mary Gabb 's article on DTC marketing, Julie Stauffer introduces us to www.PatientsLikeMe.com, a social networking initiative for patients, and Dr John Bridges of Johns Hopkins University Medical School intrigues with some thoughts on ‘the mean versus the gene: will national healthcare systems ever adopt personalised medicine?' Your editor interviews Walgreens Healthcare CEO Stanley Blaylock about how Big Box companies are promoting in-store healthcare delivery.

David Woods

“ But know also, man has an inborn craving for medicine. Generations of heroic dosing have given his tissues such a thirst for drugs... the desire to take medicine is one feature which distinguishes man, the animal, from his fellow creatures. It is really one of the most
serious difficulties with which we have to contend. Even in minor ailments,
which would yield to dieting or to simple home remedies, the doctor's visit
is not thought to be complete without the prescription.”
Sir William Osler, Canadian physician (1849-1919)

By Mary Gabb (mary.gabb@rxcomms.com)

In a previous issue of HOC , we outlined some of the commonly expressed pros and cons of direct-to-consumer advertising (DTCA), which is currently allowed only in the United States (US) and New Zealand but under consideration for Europe .

On May 5, 2008, three executives, from Pfizer, Schering-Plough/Merck and Company, and Johnson & Johnson, appeared before the US Congress Subcommittee on Oversight and Investigation, to answer questions regarding three specific “potentially misleading and deceptive tactics” used in DTCA for Pfizer's Lipitor, J&J's Procrit, and Vytorin, which is sold by Merck and Schering-Plough. The congressional subcommittee asked whether the three companies would be willing to commit to six guidelines:

• Follow the American Medical Association's guidelines regarding the use of actors and health professionals in DTCA.
• Not market products in DTCA until a valid outcomes study of the product is completed.
• Place a 2-year DTCA moratorium on new prescription drug products, as recommended by the Institute of Medicine .
• Not market off-label uses for prescription products in DTCA.
• Add the FDA toll-free MedWatch phone number in all DTCA.
• Include “black box” warnings in DTCA for products that contain such warnings.

All three companies agreed to only two of the six guidelines (following AMA guidelines on use of physicians in DTCA and placing a 6-month moratorium on DTCA for new products). Some of the companies also agreed to specific guidelines, or more often, agreed to work with FDA guidance or seek advice from the FDA on the proposed guidelines. The trade association for the pharmaceutical industry, the Pharmaceutical Research and Manufacturers of America (PhRMA), also participated in the congressional hearing. In 2005, PhRMA had developed its own guiding principles on DTCA.

DTCA are reviewed by the FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC). The reviews are for the most part voluntary, except for specific categories of drugs, such as cancer drugs, where the risk-to-benefit ratio may be weighted on the risk side. In the latter cases, the advertisement must be submitted ahead of time – but the pharmaceutical manufacturer does not have to heed the DDMAC advice nor even wait for the comments before it releases the ad.

Nonetheless, PhRMA maintains that DTCA is one of the most highly regulated forms of advertisement in the US . To date in 2008, the FDA DDMAC has issued 5 warning letters outlining regulation violations in promotional advertisements.

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The changing face of DTCA

The New England Journal of Medicine reports on a new form of DTCA of which we may be seeing more – for medical devices. (NEJM 2008;358:21). The article also describes the differences in DTCA requirements based on format – television ad, web site, and patient-education brochure. For example, the FDA requires that only “major risk information” be disclosed in broadcast DTCA, but these ads must direct viewers to other sources of information on associated risks. Print advertisements, by contrast, must include all information about associated risks (ie, major side effects, contraindications, and precautions contained in the FDA's label). As an example, a television ad for a drug-eluting coronary stent listed 4 potential adverse events related to use of stents in general, but none associated with the product. The web site listed 10 device-related adverse events, and 5 that were product-specific. The patient education brochure listed 31 device-related adverse events, and 13 product-specific adverse events. So, patients must do their homework, depending on the type of DTCA they see. A spokesperson from the FDA said that all ads – for devices and drugs – are required to not be false or misleading and to present information that is in accord with product label

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www.PatientsLikeMe.com – The power of patient-provided information

By Julie Stauffer (julie.stauffer@rxcomms.com)

Pharmaceutical companies depend on data – and lots of it – to develop drugs and measure their effectiveness. And many patients are eager to supply that information if it might mean better treatments or better quality of life.

That's the premise of PatientsLikeMe.com. Launched in 2006, it connects patients to other people dealing with the same life-altering disease. Not only does it allow users to share experiences and provide peer support, it also generates a goldmine of data by encouraging patients to track and quantify their symptoms, medications, and outcomes.

Today, the pharmaceutical industry relies on point-in-time, survey-driven information, explains David S. Williams III, the site's co-founder and head of business development. In contrast, PatientsLikeMe provides a much wider range of data.

Pharmaceutical companies can monitor its forums for insight into patient perspectives or recruit its members for clinical trials. Most exciting, however, is the opportunity to examine real-world, long-term data on how patient attitudes, decisions, and outcomes change over the course of their disease.

You now have a different longitudinal way of looking at how patients interact with your medication that you never had before,” Williams says.

To date, nearly 20,000 people from around the world have joined PatientsLikeMe, which offers on-line communities for patients with ALS, multiple sclerosis, HIV, Parkinson's, and a variety of mood conditions. Williams predicts those numbers will increase to one million patients and 200 communities by the end of 2011.

“The people we're attracting are that 5-15% of people in every single disease who will share their information openly. We know that target group exists,” he says. Once PatientsLikeMe proves that sharing medical information provides more collective benefit than keeping it private – establishing best care practices and accelerating research into treatments – he anticipates more people will overcome their privacy concerns.

But even data from the 5-15% segment alone has tremendous value, especially for a prevalent condition like heart disease. “The Framingham heart study has 5,000 people,” Williams points out. “We're talking about building 200 Framingham heart studies in 200 different diseases.”

How reliable is the information generated by PatientsLikeMe? Although patients misinterpreting or misreporting information is a very real possibility, the aggregated data is structured to make outliers evident. Because these charts and graphs are posted on the site, patients have an opportunity to spot and correct mistakes themselves. If a patient sees that she is the only person who reported taking a particular medication for a particular purpose, for example, she may realize that she's misunderstood why her doctor prescribed it.

Unlike most “health 2.0” businesses, PatientsLikeMe forgoes advertising in order to maintain high credibility with its members. Instead, revenues come from selling data to carefully screened partners that develop or sell drugs, devices, insurance or medical services aligned to the needs of patients.

While it's a model that promises profitability, the ultimate goal is to benefit the patients themselves. As the site's founders explain, “When patients share real-world data, collaboration on a global scale becomes possible. New treatments become possible. Most importantly, change becomes possible.”

“Look to your health; and if you have it praise God, and value it next to a good Conscience; for health is the second blessing that we Mortals are capable of: a blessing that money cannot buy, and therefore value it, and be thankful for it.”
Izaac Walton (1593-1683) – English author

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John Bridges, PhD, is Assistant Professor, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Senior Fellow at the Center for Medicine in the Public Interest and founding editor, The Patient: Patient-Centered Outcomes Research (see http://thepatient.adisonline.com )