One of the greatest historical challenges to the effective practice of medicine has been to ensure that healthcare providers have access to the most accurate and up-to-date information when and where they need it. While the rise of the Internet and new communication platforms connect patients and providers to more data than ever before, Food and Drug Administration (FDA) regulations limit the ability of biopharmaceutical companies from sharing truthful, scientifically-accurate information about the medicines they research, develop, and produce with healthcare professionals.
An article from The Atlantic earlier this year noted that Wikipedia is the top source of healthcare information for doctors. That statistic may not come as a shock to most – Wikipedia is one of the Internet’s most popular websites. Given that a recent Campbell University study found that nine out of 10 Wikipedia entries on health are inaccurate, patients and the entire healthcare ecosystem should be concerned about the availability of accurate data to inform treatment decisions to get the best possible patient outcomes.
How can we ensure that treatment decisions for patients are based on the most reliable and accurate sources available? A key element of a fully-informed healthcare system is allowing physicians and patients to participate in an open, data-driven dialogue involving truthful and non-misleading information regarding available treatments. This includes peer-reviewed journal articles as well as information from clinical studies and real world evidence, among other sources. In many cases, biopharmaceutical companies have valuable information to contribute to the conversation about the treatments they research and produce, beginning in clinical trials and carrying through the entire life cycle of a medicine. Unfortunately, these companies are currently limited in their ability to communicate this scientific data with physicians and other healthcare providers.
FDA regulations prohibit companies from sharing any information about treatments that is not contained within a medicine’s approved labeling. However, many medicines are used to treat conditions for which they were not originally approved, particularly in areas such as oncology and mental health. What’s more, such medically-accepted alternative uses of medicines (also known as “off-label” uses) are routinely reimbursed by the government and appear in physician-drafted medical practice guidelines. Limiting the exchange of information on how medicines affect specific groups or sub-populations of patients, new data about common and medically-accepted uses of medicines for conditions outside the existing label and large analyses of how medicines have performed over time deprives healthcare professionals of essential information to inform treatment options.
Sharing information beyond what exists on a medicine’s label becomes even more important in the treatment of rare diseases. While biopharmaceutical companies devote extraordinary resources in research and development to discover treatments for rare diseases – there are currently more than 450 such medicines in development – 95% of rare diseases do not have an FDA-approved treatment. As a result, most rare diseases are treated under protocols involving medically-accepted alternate uses of medicines. In such circumstances, preventing healthcare providers from accessing all relevant and scientifically accurate information about a treatment can be a potentially harmful disservice to patients.
Embracing a system of open communication between biopharmaceutical companies and healthcare professionals will promote greater patient safety and care. Healthcare providers are experts capable of evaluating clinical data and other types of evidence to make the best possible decisions with individual patients. Of course, the FDA would still have an important role to play in ensuring that such communications are accurate and contain enough context to allow trained professionals to make high quality treatments decisions for their patients.
As information on medical conditions and treatments is increasingly available online, but not necessarily more reliable, the healthcare ecosystem must strive for open exchange of truthful and scientifically-accurate information to enhance care delivery and, most importantly, improve patient care.
John Castellani is president and CEO of PhRMA.