When it comes to our health, “collaboration between physicians and biopharmaceutical professionals is essential to improving the care we receive and developing new medicines. Whether it is collaborating on research for new medicines or learning about the latest treatment options, interactions between physicians and biopharmaceutical professionals lead to better health and better medicine.”
This simple motto underlies a critical new initiative launched by a wide range of organizations, known as the “Partners for Healthy Dialogues.” The partnership is a collaboration between health care provider organizations and biopharmaceutical organizations to demonstrate the value of interactions between physicians and biopharmaceutical companies, from better patient care to advancing medical innovation. The Partners include:
– American Association of Neurological Surgeons (AANS)
– American College of Preventive Medicine (ACPM)
– American Osteopathic Association (AOA)
– American Urological Association (AUA)
– The Congress of Neurological Surgeons (CNS)
– National Council of Asian Pacific Islander Physicians (NCAPIP)
– The Pharmaceutical Research and Manufacturers of America (PhRMA)
– The Society of Pharmaceutical and Biotech Trainers (SPBT)
The initiative was launched largely in response to the Physician Payment Sunshine Act—Section 6002 of the Patient Protection and Affordable Care Act (PPACA), and the finalized regulations issued by the Centers for Medicare & Medicaid Services on February 1, 2013. The Sunshine Act will increase transparency when a new public database will outline the specifics of these interactions.
Ethical interactions between biopharmaceutical companies and health care professionals and increased transparency are essential to strengthening patient trust in our health care system. The Partnership is working closely with CMS to ensure that the database and information will provide simple, clear, and unbiased information so that patients and other stakeholders can better understand how these interactions improve their health and well-being.
Partners for Healthy Dialogues support transparency and the principles of the Sunshine Act, and is committed to providing meaningful background about ways in which physicians and the biopharmaceutical industry collaborate for patients. The Partnership noted that while efforts like ProPublica’s Dollars for Docs could help raise awareness for these collaborations, the limited information runs the risk of not fully conveying how and why these interactions occur.
With proper context, the Sunshine Act has the potential to help patients understand how their physicians work with biopharmaceutical professionals and how these interactions benefit their health and, more broadly, medical innovation. Partners for Healthy Dialogues was created to provide details about these collaborations and help the public understand why these interactions are essential to lifesaving medical breakthroughs, the development of new medicines, and improvements in the care we all receive.”
As the Sunshine Act is implemented, the mission of the Partnership is to provide clear, helpful information to three core groups: (1) patients; (2) health care professionals; and (3) biopharmaceutical professionals. Below is a summary of information that the Partnerships provides for each stakeholder.
Patients
Collaboration between physicians and biopharmaceutical professionals can improve patient health and advance medical innovation. A biopharmaceutical company may compensate doctors for a number of reasons all of which are rooted in patient care and/or medical innovation. What does this collaboration mean for patients and how does it happen?
Over the past few decades, the lives of physicians have become increasingly complex. From significant amounts of paperwork to evolving administrative duties and increasing patient needs, physicians are busier than ever, particularly with the advent of health information technology (HIT) and electronic health records (EHRs). Despite this increasing workload, physicians must remain current on the latest medical knowledge and practice standards, including research on new treatments and medicines.
In 2005, however, researchers found that a primary care physician would have to read 341 relevant medical journals and 7,287 monthly articles, equaling more than 627 reading hours per month, to stay up-to-date on all medical literature. Here is a breakdown of how physicians spend their day:
- 55% – Face-to-face patient care describes any time spent interacting directly with patients in a clinical setting
- 14.5% – Visit-specific work outside of the exam room
- Reviewing the medical record
- Writing notes and completing patient encounter forms
- Arranging for tests or consultations and writing prescription
- 23% – Work related to patients not currently being seen
- Reviewing medical records and lab results/writing notes
- Making telephone calls or receiving them from patients
- Fielding patient-related questions from staff
- Interacting with insurance companies
- Looking up medical information
- 7.5% – Administrative and academic activities and patient care in other settings
- Hospital rounds and teaching
- Office management
- Research and reading the latest medical information
- Home visits
Patients should understand that their physicians are concerned about their caseloads. In a recent survey, more than 75% of physicians said their practices are either at “full capacity” or that they are “overextended and overworked.” Making matters worse, physicians will become even busier over the next several years as we continue to see declining number of primary care physicians, which accounts for more than a third of all practicing physicians in the United States. In fact, American Medical Association (AMA) President Jeremy A. Lazarus recently recognized that the U.S. “will face a shortage of 130,000 physicians across all specialties by 2025” and that this “shortage will be exacerbated by the increased demand on our health care delivery system as more seniors enroll in Medicare and newly insured Americans seek access to care.
Physicians turn to multiple sources of information to make decisions about prescriptions and care, including 1) their clinical knowledge and experience, 2) their patients’ responses to particular medicines, 3) each patient’s particular situation, which might include drug interactions, side effects and contraindications, 4) clinical practice guidelines, 5) discussions with colleagues/peers, and 6) articles in peer-reviewed journals.
For example, a recent survey showed that physician’s best means for learning about new medications and treatments is industry-supported continuing medical education (CME) programs (52%), followed by medical journals (51%), followed by industry (17%), colleagues (14%), and internet (including social media) content (13%). 66% of respondents said they trust the information they get from industry. Physicians weigh all of this information when making the best prescribing decisions for you.
However, a 2011 survey showed that more than four in 10 physicians find it difficult to stay informed about new medicines, but 79 percent said meetings and discussions with biopharmaceutical professionals are help ensure that they stay current on medical information while balancing heavy workloads to address these concerns. As physicians’ time becomes more and more limited, sometimes the only available time to meet with a biopharmaceutical professional to catch up on the latest developments related to medicines is over a brief lunch break, which is typically modest in nature, such as a sandwich or salad.
Biopharmaceutical professionals spend this time keeping physicians abreast of emerging safety, benefit, and risk information; new studies and the latest clinical information and trial results; appropriate dosing; new FDA approved drugs and treatments; and new indications, as appropriate. Such information is critical to physicians because it could affect their decisions about appropriate patient care. For example, many medicines require post-approval research to ensure that medicines are being used safely and appropriately. By meeting with physicians to convey such information, such as a safety concern, companies ensure that patients using that product are provided with alternatives to avoid a treatment gap.
Such professionals also engage with physicians to discuss the ways their patients respond to the company’s medicines beyond a controlled clinical trial setting and to discuss disease challenges more broadly. These in-person meetings provide a level of detail that a physician cannot get through literature alone. In addition, physicians can ask questions specific to a medicine that the biopharmaceutical professional has deep expertise and knowledge about or the professional can refer the physician to the company’s medical liaison for even more specialized information.
These conversations enable physicians to share real-world feedback on how well the medicines are working, how patients react to prescribed medicines, patient compliance, and any side effects. This information helps companies make improvements and advancements for patient care and can prompt biopharmaceutical professionals to conduct additional research that could translate into a product change or new treatment protocols that can benefit patients.
Physician meetings with biopharmaceutical professionals are also critical because physicians learn about company-sponsored programs that offer free or discounted treatments from their doctors to patients who do not have prescription drug coverage. This helps ensure that patients can actually take their medicines as prescribed, which can benefit their health, and reduce the need for hospitalizations and other expensive medical care. Such meetings also ensure, in compliance with federal and state law, that physicians can give samples to patients to help start treatment early or to determine proper dosing or any unwanted side effects.
Ultimately, patients should understand that your physician collaborates with biopharmaceutical professionals to get the information they need to make the best health care decisions for you. Moreover, federal law strictly prohibits companies from compensating physicians for prescribing a particular medicine or course of treatment. Instead, doctors rely on the information noted above in making their prescribing decisions and make such choices on a case-by-case basis and in the best interest of each patient. Further, over 75% of prescriptions in the U.S. are for generic drugs.
Patients – Research
Before medicines are approved for patient use, they must be tested extensively through clinical trials. The discovery of new and improved medicines is dependent on research collaborations between physicians and biopharmaceutical companies. In fact, new medications cannot be sold in the United States until they have been tested through clinical trials. Clinical trials sponsored by biopharmaceutical companies have led to life-saving breakthroughs for people suffering from cancer and other life-threatening diseases. These include the first ever vaccine to protect against cervical cancer, a breakthrough treatment for Cystic Fibrosis, and a therapy that helps adults suffering from multiple sclerosis.
Patients should understand that physicians play an integral role in the success of clinical trials, as they carry out research, track patient progress, report the research in peer-reviewed journals, and complete patient evaluation forms, among other responsibilities. Physicians are compensated appropriately for the time all this work requires, and never based on the outcome of the trial results (click here for the Sunshine Regs on research payments). Physicians who participate in clinical trials are likely to have a better understanding of research outcomes and to interpret the data objectively. Moreover, biopharmaceutical companies respect the independence of physicians and entities involved in clinical research to exercise their judgment to ensure that results are interpreted fairly.
Patients should also be aware that biopharmaceutical companies, the federal government, academic medical centers and hospitals sponsor clinical trials. In fact, 70% of funding for clinical trials in the U.S. comes from the biopharmaceutical industry. In a recent survey of physicians, 94 percent felt that it is useful for biopharmaceutical companies to sponsor clinical trials to research new medicines and treatments.
Clinical trials occur across the country, with over 2,000 in Massachusetts in state clinical research centers, university medical schools and hospitals, who are working together with biopharmaceutical companies to target the nation’s six most debilitating and chronic diseases. As the health care environment continues to rapidly evolve, these collaborations will remain crucial to the discovery of new and improved medicines and to address unmet medical needs worldwide and harness the full potential of new scientific discoveries.
Patients should also be aware that companies work with physicians to conduct research throughout the entire lifetime of a medicine, long after FDA-approval. In fact, many biopharmaceutical companies invest more than a third of their research budget on post-approval studies related to safety to ensure that physicians continue to use such drugs safely, appropriately and effectively with patients.
Regulations for the conduct of clinical research are enforced by the FDA, but many different entities and individuals contribute to the safe and appropriate conduct of clinical research, including investigative site staff and medical professionals who serve as clinical investigators; hospitals and other institutions where research is conducted; and institutional review boards and ethics committees. The public or private entity that conducts the trial is responsible for the ethical conduct of the study and for ensuring that rigorous scientific standards are upheld. The American Medical Association has established guidelines for physician participation in clinical trials and all research collaborations between physicians and biopharmaceutical professionals are upheld with the highest professional standards, and by those set by their respective associations:
- AOA – Code of Medial Ethics on Interactions
- American Association of Neurological Surgeons – Code on Interactions
- American Urological Association – Code of Ethics
- American College of Preventive Medicine – Code of Ethics
- PhRMA – Code on Interactions with Healthcare Professionals
- AMA – Code of Medical Ethics on Interactions
- AMA – Information on the Sunshine Act
Patients – Company Sponsored Education
In addition to the meetings that biopharmaceutical professionals have with physicians or group practices, biopharmaceutical companies sponsor speaker programs. Company-sponsored education programs are one of the most useful ways for physicians to gain knowledge and skills that help their patients. According to a 2011 physician survey, more than half of attendees at peer speaker events say they often gain knowledge or skills that are helpful to their practice.
Physicians who attend and present at these events do so to 1) expand and improve their clinical knowledge; 2) learn about potential side effects of medicines; 3) learn about new uses for medicines; 4) learn about the latest clinical data; and 5) learn about the range of treatment options and emerging safety and risk information. Many of these programs could not take place without the sponsorship of biopharmaceutical companies.
Company-sponsored education programs also fill an educational gap and are especially important to for primary care and rural physicians charged with treating everything from lung conditions to migraines. Moreover, physicians in rural communities have limited peer interactions and access to professional conferences. A biopharmaceutical-sponsored event, led by a well-qualified physician, may be their most convenient opportunity to learn the latest information on treatments. In fact, a 2011 survey showed that 86 percent of rural physicians attend company-sponsored education programs.
Physician education programs allow physicians to interact face-to-face and learn about some of the most complex disease states and treatments available. While medical technology evolves and becomes increasingly complex, face-to-face interactions among physicians provide a level of detail that is hard to capture in literature, including peer-reviewed journals. In person education allows for an open discussion about advancements made in patient health and medical innovation. This kind of interaction helps their peers gain a better understanding of specific therapies and also provides a forum for those who might have questions about treatment options.
To help ensure that the scientific information presented is accurate and up to date, biopharmaceutical companies sponsoring these educational events comply with both federal requirements and stringent self-imposed standards. For example, the FDA holds companies accountable for the presentations of their speakers; materials presented at these events must include all FDA-approved product information, and must be truthful, accurate and consistent with product labeling approved by the FDA.
The PhRMA Code also contains detailed provisions specific to the conduct and training of speakers. Under the PhRMA Code, company decisions regarding the selection of physicians are based on defined criteria such as medical expertise, reputation, knowledge and experiences in a particular therapeutic area, and communication skills. Companies take active steps to ensure that qualified speakers are carefully vetted and meet the highest ethical standards whenever they present at company-sponsored educational events.
Biopharmaceutical companies pay physician experts to speak at these seminars and educational programs because physicians are uniquely qualified to educate their peers about the medicines and treatments they prescribe and new innovations in an effort to foster improved patient care on a larger level. Physicians receive reasonable compensation for their time to prepare and deliver the presentations, as is customary with most speaker programs. Physicians who attend such programs may also receive compensation in the form of travel, lodging, meals, or educational items and materials such as slides or handouts. Any compensation or reimbursement is based on fair market value, per PhRMA’s Code.
Patients – Independently Accredited Education With Commercial Support
By necessity, physicians are lifelong learners who must stay up-to-date on the evolving science of medicine. However, for busy physicians, pouring over stacks of journal articles on the latest treatments may be unrealistic. To address this concern, almost every state in the U.S. requires that physicians receive continuing medical education (CME) every year to maintain their license to practice. CME offers a convenient opportunity to learn about new medicines that could prove safer and/or more effective for patients (click here for Sunshine Regs on CME).
Consequently, some biopharmaceutical companies also provide financial support for CME. The Accreditation Council for Continuing Medical Education (ACCME) sets the specific standards for such support, as well as the biopharmaceutical sector’s voluntary guidelines. Biopharmaceutical companies sponsor CME programs to enable physicians to improve their clinical knowledge, learn about new uses for medicines, and present their own research findings about the impact of medicines and treatments for their patients. These educational events are also designed to help raise awareness of innovative treatments—treatments that some doctors might not know exist—that can help improve the health of patients suffering from life-threatening and life-debilitating diseases such as cancer, heart disease, and diabetes.
Sharing their experiences, knowledge and expertise with other physicians is a crucial part of the learning process and he exchange of such information improves patient care. In fact, CME has been proven to improve patient outcomes in areas such as multiple sclerosis, hypertension, COPD, ICU patients, improved taking of family history by physician assistants, Sepsis, healthcare-associated infections, reduction in CT scans, and several other areas.
HEALTH CARE PROFESSIONALS
The page for health care professionals includes general information about the Sunshine Act regulations and requirements. It informs physicians that transparency in the various activities noted above “can help maintain trust in the health care system.” The page informs physicians that they, their patients, media, and other stakeholders may have questions about publicly disclosed payments. Accordingly, this page provides resources to physicians to help answer those inquiries and other questions that may arise. The page also provides resources to help physicians explain to your patients and the public the importance of collaboration. In light of the upcoming deadline for companies to begin reporting—August 1, 2013—this page recommends that physicians:
- Get details on the financial reporting requirements that biopharmaceutical professionals must follow in documenting interactions with physicians.
- Equip yourself with information and tools to share with patients how physician-biopharmaceutical professional collaboration helps them and furthers medical innovation.
- Download materials you can share with patients and peers, including FAQs, fact sheets, and a brochure.
The site allows physicians to receive Sunshine updates, news and to be alerted when the new database goes live.
Biopharmaceutical Professional
This page explains to professionals that “implementation of the Sunshine Act begins now, and it’s important for you to understand what it means and how it impacts you and the physicians you work with.” The page provides resources on the Sunshine Act and tips to help professionals talk about the various ways in which collaboration between biopharmaceutical professionals and physicians leads to better patient care and future medical innovations. The page also allows professionals to sign up to receive information and updates as it becomes available. In the meantime, the Partnership recommends that professionals:
- Equip yourself with information and tools to share with physicians about how physician-biopharmaceutical collaboration helps them and furthers medical innovation.
- Share downloadable materials with your physician contacts to help them encourage a dialogue with their patients and peers, including FAQs, fact sheets, and a brochure.
Finally, this page emphasizes the importance of biopharmaceutical professionals maintaining ethical and transparent relationships with all health care professionals, which is crucial to building trust in our health care system. It also emphasizes the PhRMA Code on Interactions with Healthcare Professionals, which sets industry-wide standards for these interactions to ensure that they are professional, ethical, informational exchanges designed to benefit patients and to enhance the practice of medicine.