PM360 June 2010

Hot Topics / Healthcare Highlights

New Disclosure Reporting
Aggregate spend and disclosure reporting is a hot topic among Life Science companies as six states have legislation, several large states (New Jersey, New York, and Texas) have pending legislation, and federal-level disclosure will soon be required thanks to the healthcare reform legislation. “It’s a growing challenge for these companies,” said Bill Buzzeo, Vice President and General Manager of Cegedim Dendrite’s Compliance Solutions. “Historically, they have been able to meet a handful of state requirements with spreadsheets or internally developed systems. [Under new legislation] the requirements aren’t just about what did you spend on the doctor when you were promoting your drug.” Some states require companies to report at the practitioner level while others want the amount spent on resources for selling and promoting, R&D, and clinical trials, and come 2013 the new federal law will require reporting across the country, said Buzzeo. With the increasingly complex reporting requirements, companies are seeking help.

Cegedim Dendrite’s 2010 Aggregate Spend and Disclosure Reporting Industry Survey found 40% of respondents still use manual reporting practices. However, over half plan to either outsource or automate the process internally to deal with the new federal requirements. The survey also found few respondents have complete faith in their current reporting techniques. Only 29% are very confident they are fully compliant with current regulations and only 17% are very confident they are collecting all reportable data. Cegedim Dendrite’s Aggregate Spend-360 tracks and analyzes all compliance data and generate reports. It also offers a user interface to enter data manually and will soon launch in Europe to help U.S. companies with affiliates abroad.. —Andrew Matthius

Cellphone Risk?
Approximately 4.6 billion cellphone users have been wondering for years: Does using cellphones increase the risk of cancer? Well, after the largest ever study on the subject, surveying 13,000 people across 13 countries over 10 years, there is still no definitive answer. Experts were nearly unanimous in declaring the results of the study by the World Health Organization’s International Agency for Research on Cancer (IARC) to be inconclusive. Or as IARC's director Christopher Wild told Reuters: “The results really don’t allow us to conclude that there is any risk associated with mobile phone use, but it is also premature to say that there is no risk associated with it.” The study found that the 10% of participants considered heavy users had a 40% increased risk of glioma, according to results published in the International Journal of Epidemiology. However, the study found no increased risk for the more common meningioma. In fact the results revealed cellphone users actually had a lower risk of cancer than people who never used one, which led the study’s 21 researchers to question its methodology.

The study was conducted as a survey asking participants to recall total usage over the past decade. Many of the researchers believe possible “recall error” could have skewed the results, according to the Associated Press. Wild told Reuters another problem with the survey is that mobile phone usage has changed dramatically since 2000. In the study, heavy use is defined as 30 minutes or more on actual calls each day, which today is considered common. In the hope of finding conclusive data, European scientists last April launched an even larger study. This one will eliminate the possibility of recall error by tracking people and their usage over the course of 30 years.
—A.M.

Unbranded Websites
Pharma marketers are increasingly interested in unbranded online
initiatives because of looming DTC restrictions, a growing emphasis on improving customer care, and to extend the reach of their brands, according to a new Manhattan Research report, Unbranded Websites: Extending Brand Reach throughout the Patient Life Cycle, which offers pharma marketers key data, insights, and strategic considerations. The research shows that more than half of e-pharma consumers have used or are interested in unbranded websites because they are open to the value they can provide, noted Monique Levy, Senior Director of Research. In general, product sites are mostly researched by consumers after diagnosis, while patients in the early stages of a disease are more likely to visit unbranded websites. A complementary strategy using both allows marketers to reach a wider net of patients on the treatment continuum, said Maureen Malloy, Healthcare Marketing Analyst.

Consumers want practical help from unbranded sites such as how to find a specialist, tools to help manage their condition, or information about an uncommon disease, said Levy. She added that the content depends on a variety of issues including marketing goals, therapeutic category, and competitiveness of the drug. One great example is www.PKU.com from BioMarin. According to Malloy, the site focuses on a niche disease (phenylketonuria) lacking online resources and was successful because it gave a small patient population a platform where they could share their experiences through a variety of social media features. “The extent to which a company can benefit from unbranded strategies varies greatly by disease category and product situation, but under the right circumstances, this type of investment can support lead generation, relationship marketing, and awareness and education initiatives,” said Malloy. “A recent warning letter sent about two Novartis unbranded websites will likely lead to a more conservative approach by most brands.” —A.M.

FDA UPDATE

In an effort to help healthcare professionals recognize and report misleading prescription drug advertisements, the FDA has launched the Bad Ad Program, administered by the agency’s DDMAC, to be rolled out in three phases. Phase 1 began last month as DDMAC started to engage with healthcare providers at medical conferences and partner with medical societies to distribute educational materials. Phases 2 and 3 will expand on these efforts. Bad ads can be reported by sending an email to badad@fda.gov or calling 877-RX-DDMAC.

The FDA has approved Dendreon’s Provenge (sipuleucel-T) as a treatment for certain men with advanced prostate cancer. The treatment stimulates a patient’s own immune system to respond against the cancer. It is intended for patients with prostate cancer that is either asymptomatic or minimally symptomatic and which has spread to other parts of the body and is resistant to standard hormone treatment.

The FDA has revised its recommendations for rotavirus vaccines for the prevention of the disease in infants and has determined it is appropriate to resume the use of GlaxoSmithKline’s Rotarix and to continue the use of Merck’s RotaTeq. The benefits of the vaccines are substantial as they can prevent death in some parts of the world and hospitalization for severe rotavirus disease in the United States.

Asthmatx’s Alair Bronchial Thermoplasty System is the first medical device to use radiofrequency energy to treat severe and persistent asthma. The FDA has approved the device for patients age 18 and older with asthma that is not well controlled with inhaled corticosteroids and long-acting beta agonist medications.  
—A.M.