Thanks to Tom Sullivan for providing this roundup of information on current issues that affect the healthcare communication industry. For more of Tom”s commentary and analysis, visit his blog at www.policymed.com
Since the passage of the Patient Protection and Affordable Care Act (the health care reform), there has been much discussion on what happens now. This month we look at timelines and events that will shape CME.
Other news includes:
- MSS recently released their guidance of interaction with companies
- Pfizer discloses payments to physicians
- Georgetown Conference on CME funding and its ties to alternative medicine
- The FDA released draft guidance”s on DTC and COI in advisory boards
- FDA holds hearing on FDUFA
- The Association of Clinical Researchers and Educators is presenting in a open session this Saturday May 1, at 3:30pm on COI at the ASH annual meeting in New York
- Macy Foundation is holding a Health Care Briefing on CE on Thursday May 13, to promote the report they sponsored at the IOM. (Though no mention of IOM in the announcement)
- The FDA is holding a hearing on Friday April 30, 2010: Voting and Nonvoting Consumer Representative Members on Public Advisory Committees and Panels
- For at least one committee in the US Senate the next big event for them is the IOM Report on FDA Medical Device Approvals “Public Health Effectiveness of FDA 510(K) Clearance Process” expected summer of 2011.
The Council of Medical Specialty Societies (CMSS) which represents 32 leading medical professional societies, with a collective membership of more than 650,000 U.S. physicians released the CMSS Guidance for Interactions with Companies.
The guidance provides detailed guidance to medical specialty societies on appropriate interactions with for-profit companies in the health care sector. The voluntary guidance is designed to ensure that societies” interactions with companies are independent and transparent, and advance medical care for the benefit of patients and populations.
Although the database of payments to physicians from pharmaceutical and device companies, required by the recently passed Physician Payments Sunshine Act, will not be posted until September 2013, some are predicting that its impact will reduce such payments. A recent article in Kaiser Health News described how the new law will require companies to begin recording any physician payments that are worth more than $10 in 2012 and to report them on March 31, 2013.
Continuing the ongoing trend of transparency and disclosure in the pharmaceutical industry, Inc. released its payment information for the second half of 2009. The reported that all together, the company paid $35 million to about 4,500 health-care professionals who consulted with the pharmaceutical maker on the development and marketing of new pharmaceuticals and other matters.
Dr. Margaret A. Hamburg, Commissioner of the Food and Drug Administration (FDA), sent a letter to colleagues and staff regarding the disclosure of financial conflicts of interest (COIs). The purpose of her letter was to share her perspective on “the challenge of assembling top experts to advise the organization while maintaining the integrity of FDA”s decision making processes. It also served as a message to make staff aware of “a new draft guidance on transparency and advisory committees,” which she hopes will address these challenges.
In 2012 Congress will be revisiting Prescription Pharmaceutical User Fee Act (PDUFA). In an effort to prepare the FDA is asking for comments and holding hearings on this law to ensure it is up to date.
The Food and Pharmaceutical Administration (FDA) has recently issued proposed guidance for direct to consumer ads as directed by the Food and Pharmaceutical Administration Amendments Act of 2007 (FDAAA). The guidance calls for clear, conspicuous and neutral standards.
A recent article in the Journal of the American Medical Association (JAMA) discusses how to “Build Comparative Efficacy and Tolerability Into the FDA Process.”
The current responsibility of FDA is to provide the public with the “science-based information” it needs to use pharmaceuticals and devices to improve health. To provide such information “under the current Federal Regulations (CFR), new approval is typically based on demonstration of efficacy in 2 or more randomized clinical trials (RCTs), often in comparison with placebo.”
Keeping track of the progress made since an OIG report on the CDC, Senator Charles Grassley (R-IA), sent one of his letters to Thomas R. Frieden, M.D., M.P.H., the Director of CDC, expressing his concern about conflicts of interest (COI). Citing the same examples he has used for the past two years (Emory, Stanford and Harvard), Mr. Grassley used these exceptions (not examples) to ask for documents and responses to questions including the names of their advisors.
The American Medical Association (AMA) Task Force on Continuing Medical Education (CME) for Provider/Industry Collaboration consists of nearly 50 senior professionals in CME with various backgrounds in medicine and healthcare.
Their most recent fact sheet, dealing with on-label and off-label use of pharmaceuticals and devices, described how healthcare products must be proven “safe and effective” by the FDA before they are marketed. Once approved, FDA and the manufacturer agree on, among other things, what the pharmaceutical or device can be used and prescribed for.
This summer, in an attempt to discredit modern innovative strategies for educating physicians, PharmedOut a pro-alternative medicine anti pharma group under the umbrella of Georgetown University will be holding a conference titled: “Prescription for Conflict: Should Industry Fund Continuing Medical Education?”
The conference, which is being held at Georgetown University, is billed as a joint effort between Georgetown University Medical Center, the Kennedy Institute of Ethics, and Georgetown University Law Center without mention of PharmedOut. The organizer and chairman of the meeting is an Associate Professor in the Complementary and Alternative Medicine Master”s program.
In response to the Institute of Medicine”s recently published report titled “Redesigning Continuing Education in the Health Professions”, the Council of Medical Specialty Societies (CMSS) asserted that a Continuing Education Institute accountable to the federal government is unnecessary.
With more and more studies showing that America is going to be facing a significant shortage of physicians in the near future–150,000 by 2025–any other factors that could reduce the physician workforce will harm patients significantly, especially now that health care “reform” has passed.
Unfortunately, a recent noted that shortages will not be the only problems because “as many as 10% of the nation”s 750,000 physicians will demonstrate “significant deficiencies in knowledge or skills” at some point in their career, according to Harvard University patient-safety expert Lucian Leape. What this means is that physicians are going to need more continuing medical education (CME) programs to address these “significant deficiencies in knowledge or skills.” This need will also be critical as millions of patients enter the health care system.
The Accreditation Council of Continuing Medical Education (ACCME) recently announced that it will be opening up its Program & Activity Reporting System (PARS) Education Phase in April. The program, a Web-based portal designed to streamline and support the gathering of program and activity data from continuing medical education providers, is expected to run for four weeks.
A recent discussion about Continuing Medical Education (CME) with Steven Kawczak, MA, associate director for the Center for Continuing Education (CCE) at Cleveland Clinic, highlighted a study he conducted this year regarding industry support of CME.
They noted that “until recently there have been no scientific studies proving–or disproving–that pharma or device makers” support of CME inherently introduces bias into the activity.” That is, until Kawczak and his colleagues at the clinic decided to analyze the CCE”s database of evaluations collected from 346 CME activities of all types for the year 2007. What they found was contrary to popular belief.
Steven L. Dubovsky, MD, professor and chair of the Department of Psychiatry at the University at Buffalo, along with four other professors in the Department of Psychiatry at Buffalo, and one pharmaceutical company representative, conducted a study to answer the following question: “Can Academic Departments Maintain Industry Relationships While Promoting Physician Professionalism?” The study itself contains a disclosure statement as well, and acknowledges that “a large number of clinical investigations at the University at Buffalo were supported by industry-sponsored projects.”
The Miami Herald reported that the University of Miami medical school has become one of the first in the country to offer an online, searchable database explaining its physicians” relationships with outside businesses.
The payment data, is searchable by name of faculty member or by name of company. It will be updated at least annually and now includes data for fiscal 2009 — which ended May 31, 2009. It lists physicians” relationship with outside companies — but not the dollar amounts of the deals, which will start to be added later this year.
“Advances in biomedical research continue to create significant possibilities for improving the detection, treatment, and prevention of disease,” according to a recent Institute of Medicine (IOM) report titled “A National Oncology Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program.
This report calls for more cooperation with government agencies, academia and industry to reduce the startup time of clinical trials.
Pharmaceutical and Device
IMS Health reported that the size of the global market for pharmaceuticals is expected to grow nearly $300 billion over the next five years, reaching $1.1 trillion in 2014.
The 5 – 8 percent compound annual growth rate during this period reflects the impact of leading products losing patent protection in developed markets, as well as strong overall growth in the world”s emerging countries.
While media, politicians, and critics continue their crusade to limit physician-industry relationships, recent evidence suggests that the work between physicians and industry is helping patients. Specifically, the reported that “the myocardial infarction rate among elderly Americans appears to be falling sharply” because of using new medicines and treatments for prevention.
Generic pharmaceuticals account for 75% of prescriptions issued in the United States, up from 57% just five years earlier.
Thomas Friedman, author of the world is flat outlines how small medical device start-ups can drive innovation and help develop devices and therapies. These small companies create exactly the types of high paying jobs that build our economy. Potentially standing in their way is burdensome regulation.
The Milwaukee, Wisconsin continued on its track to discredit physicians working with industry by publishing an article about “sixty-nine Wisconsin physicians who were on the payroll of Pfizer.” The article comes in response to Pfizer”s recent list of payments (see here) made to physicians who were speakers, consultants and researchers. The article noted that the Wisconsin physicians made more than $200,000 combined, which is an average of less than $3,000 per physician. This average was not much less than the $3,400 national average Pfizer paid for a speaker during the same time period.
Stephen F. Hodgson, MD a Mayo Clinic endocrinologist in an editorial published in the Rochester Post-Bulletin argued that physicians are able to make their own judgments and against legislation introduced in Minnesota basically banning interaction between physicians and industry.
Health Care Reform
Now that the Patient Protection and Affordable Care Act (PPAC) is law, there are some important dates and timelines for how this sweeping new health care reform will be implemented. Of course these are deadlines, and it is up to the Federal Government to implement.
According to a recently released Rutgers study by Stuart Shapiro, the mean time for completing a regulation from start to finish is 831 days or about two and a third years. This being a piece of immensely complicated legislation (3000 pages with the reconciliation package) we anticipate that this timeframe may be even longer.
By adding nearly 31 million more people to the U.S. health care system, the success of Patient Protection and Affordable Care Act (PPAC) will largely rest on the progress of one major organization in dealing with the new influx of patients who will be using two of the government”s largest run health programs. To begin this implementation, the President yesterday appointed Dr. Donald Berwick for Administrator of CMS.
Just as the Obama Administration added 31 million to an already overworked and understaffed health care system, the New York Times noted a “quiet revolution” occurring in America that is transforming how medical care is delivered in this country. The impact of this “revolution” “could have a big impact on that law”s chances for success.”
For example, “an increasing share of young physicians, burdened by medical school debts and seeking regular hours, is deciding against opening independent practices.” This kind of trend could be extremely harmful to patients who seek physicians, and would only add to the crowded waiting rooms. Because of this trend, physicians are now accepting salaries at hospitals and health systems, and older physicians — “facing rising costs and fearing they will not be able to recruit junior partners — are selling their practices and moving into salaried jobs, too.”
While health care reform has taken a national stage over the past year, states have also begun introducing legislation to address health care issues as well. In particular, Alaska, Arizona, Connecticut, Hawaii, Illinois, Minnesota, Colorado, and Washington, among others, have introduced bills including but not limited to prescription marketing, data mining, and gifts or payments to physicians. We have been working on this for some time, and since writing several states legislatures have gone out of session without passing bills including Maryland and Maine.
A recent article in BusinessWeek discussed how “pharmaceutical companies spent almost $2.6 million on marketing their products to Vermont physicians and hospitals in the 12 months ending July 1, 2009.” According to a report issued by the l, the new Vermont law, which took effect during this time frame, is “expected to sharply reduce this kind of spending.”
The report was the seventh one from Mr. Sorrell regarding Pharmaceutical marketing disclosures and is based on disclosures of payments made during the period July 1, 2008, through June 30, 2009, in adherence to Vermont”s Pharmaceutical Marketing Disclosure Law, 18 V.S.A. § 4632. The report notes how this law was “amended substantially in 2009 to prohibit most gifts, to require reporting by manufacturers of biologics and medical devices, and to eliminate the trade secrets exception to public disclosure.”
In our summary of state bills, we summarized AB 2112, a bill that seeks to regulate prescription information–in other words, prohibit data mining. Specifically, the legislation, which was modeled after a similar law in New Hampshire which stated purpose is “reined in the sale of physicians” prescription records for marketing purposes,” according to . The bill was shelved by the sponsor due to lack of support on the committee.
In response to the Massachusetts policy of Conduct which bans meals at FDA regulated events, Dr. Carlat recently debated Steve DiFillippo, owner of Davio”s and Avila”s on the effect the law is having on area businesses. The debate was aired on the WGBH program Greater Boston, and was hosted by Emily Rooney (daughter of 60 minutes fame Andy Rooney).
Prior to the debate, the segment noted how in addition to the hurting economy, restaurants and their employees have been suffering tremendously due to the loss of business from the gift ban law. One business owner estimated his losses $65,000, and a waitress estimated that she was losing $400 a week.
A recent article in PLOS One, titled “Citability of Original Research and Reviews in Journals and Their Sponsored Supplements,” examined the use of “supplements to biomedical journals, which can be used as a forum to highlight a particular disease state or intervention.” The article focused on how such supplements are “often sponsored by a commercial enterprise with a position in the topic being discussed, such as a pharmaceutical company wishing to promote their medications.” It was noted that “usually the supplement is funded through an unrestricted grant and CME credits may or may not be provided.”
A recent paper from the CATO Institute, titled “Scientific Misconduct The Manipulation of Evidence for Political Advocacy in Health Care and Climate Policy,” highlighted how “science is increasingly being manipulated” based on the political choices and ethical preferences of those who are willing to suppress evidence of conflict between those preferences and the underlying reality. In health care scientific manipulation is largely for political and not economic reasons.
ASH is hosting a session at their annual meeting featuring presentations from the Association of Clinical Researchers and Educators on Saturday, May 1st at 3:30pm – 5:00pm at the Hilton Hotels and Towers in New York City.
This panel will address some key concerns identified as critical to improving our perception and the success of our mission including conflict of interest, legislative action, and state and federal government affairs. How issues addressing CME should be addressed throughout your entire enterprise including outside stakeholders.buy levitra low price