Patients Come First
It is a distracting time for the biopharmaceutical and medical device industries. Everyone is scrambling to gain advantage in the Senate health reform negotiations. Two major pharmaceutical companies disappeared in mega-mergers last week. Reportedly, more medical product companies are working on settlements with the Department of Justice.
All this frenzy makes it a good time to stop, draw a breath and remember why seriously-ill patients care about the success of biopharmaceutical and medical device companies.
Medical products—drugs, biologics, devices—are the hope of millions of Americans who are in ill health, disabled, or face the prospect of chronic disease. Patients want relief from symptoms, reduction in pain, the slowing of chronic disease and fewer restrictions on their ability to think, communicate and manage their own lives.
Who can deliver this? NIH research is essential to the advancement of biomedical science. But it is industry that creates the products for FDA to review for safety and efficacy. Take the companies out of the equation and you have nothing.
For this reason, seriously-ill patients need the biopharmaceutical and medical device industries just as much as industry needs patients. They share a common mission and a pressing need to improve public and individual health. It should be basis for a stronger alliance than exists today.
To unlock this additional potential, industry needs to rise above the many distractions that are unrelated to the needs of patients. Patients don't care which company bought another company, what US Attorney is announcing a lawsuit today, or whether there is a regulatory pathway for follow-on-biologics. Seriously-ill patients want innovations that provide relief and cures and they want to be able to manage their own care.
FDA's two hearings this week--one on risk communications and the other on the use of social media in medical product promotion--provide a timely example. Patients want reliable information in a context they can understand. They would like to be informed without being scared by long lists of unlikely side-effects. Patients want their doctors to be knowledgeable and don't really care how their doctors received truthful, medically-useful information.
In short, patients are not interested in communications that elevate structure over content, coherence or accessibility.
Arguably, this is an area where industry let itself become distracted by its battle with FDA on marketing issues. An earlier resolution might have been possible if a patient-centric approach had been advanced, rather than a commercial one.
Most seriously-ill patients wake each morning wondering how they will surmount the day's challenges. They are concerned about the health of all Americans, but can't help being focused upon their own medical situation. Most of the people I know in the medical products industry wake each morning with the hope that their day's efforts can contribute to improving the health of all Americans, as well as provide specific benefits to seriously-ill patients.
The world-views of patients and industry are not dissimilar. They can share a dream (and an action plan)…if it is built on an unwavering commitment to patients coming first.
Steven