{"id":44517,"date":"2014-03-04T20:43:22","date_gmt":"2014-03-05T01:43:22","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=44517"},"modified":"2014-03-04T21:03:27","modified_gmt":"2014-03-05T02:03:27","slug":"bought-men","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/03\/04\/bought-men\/","title":{"rendered":"kudus to AL·AK·AR·ID·IN·NC·OK·RI·UT·WI…"},"content":{"rendered":"\n

From the letter<\/a> in the last post…<\/p>\n\n\n
\n
October 28, 2013<\/div>\n
Secretary Kathleen Sebelius<\/div>\n
U.S. Department of Health and Human Services <\/div>\n
200 Independence Avenue, S.W. <\/div>\n
Washington, D.C. 20201 <\/div>\n

Dear Secretary Sebelius: <\/p>\n

The undersigned physician organizations representing both national medical societies and state medical societies are writing to express our serious concerns about the Center for Medicare and Medicaid Services’ [CMS] recently promulgated regulations to the Sunshine Act and their impact on scientific peer reviewed medical journals and textbooks. We believe the regulations in this regard are contrary to both the statute and congressional intent and will potentially harm patient care by impeding ongoing efforts to improve the quality of care through timely medical education. <\/p>\n

The Sunshine Act was designed to promote transparency with regard to payments and other financial transfers of value between physicians and the medical product industry. As part of this provision, Congress outlined twelve specific exclusions from the reporting requirement, including “[e]ducational materials that directly benefit patients or are intended for patient use.” In its interpretation of the statute, CMS concluded that medical textbooks, reprints of peer reviewed scientific clinic al journal articles and abstracts of these articles are “not directly beneficial to patients, nor are they intended for patient use.” We believe this conclusion is inconsistent with the statutory language on its face, congressional intent, and the reality of clinical practice where patients benefit directly from improved physician medical knowledge. <\/p>\n

The importance of up-to-date, peer reviewed scientific medical information as the foundation for good medical care is well documented. Scientific peer-reviewed journal reprints, supplements, and medical text books have long been considered essential tools for clinicians to remain informed about the latest in medical practice and patient care. Independent, peer reviewed medical textbooks and journal article supplements and reprints represent the gold standard in evidence-based medical knowledge and provide a direct benefit to patients because better informed clinicians render better care to their patients. Moreover, Congress included a specific exclusion of items that directly benefit patients, such as reference materials that are often used side-by-side with a patient as a first resource when a patient brings an unfamiliar medical issue to a clinician. Many medical textbooks & scientific medical journal supplements and reprints are used in this way by physicians. The design of the reporting requirement presents a clear disincentive for clinicians to accept high quality, independent educational materials; an outcome that was unintended when the provision was passed into law. <\/font><\/strong><\/p>\n

The Food and Drug Administration [FDA]’s 2009 industry guidance titled “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices” underscores the importance of this scientific peer reviewed information. The FDA noted the “important public health and policy justification supporting dissemination of truthful and non-misleading medical journal articles and medical or scientific reference publications.” FDA guidelines for reprints provide that medical reprints should be distributed separately from information that is promotional in nature, specifically because the reprints are designed to promote the science of medicine, are educational, and intended to benefit patients. We believe the Sunshine Act was designed to support the dissemination of this type of educational material.<\/p>\n

We are concerned that the final regulations could inadvertently prevent the timely distribution of rigorous scientifically reviewed medical information to clinicians and patients and thereby undermine efforts to improve the quality of care provided to patients. This was not the intent of Congress when they passed the Sunshine Act as evidenced by the statutory language. We request that you reverse this policy and place textbooks and scientific peer reviewed medical journal reprints, supplements, and abstracts among the items excluded from the Sunshine Act’s reporting requirements. As clinicians, patients and providers of health care we know that these materials provide a direct benefit to patients and are critical for patient care. <\/div>\n<\/td>\n<\/tr>\n<\/table>\n

The tragedy of this letter is in who signed it:<\/p>\n\n\n
\n
American Academy of Child and Adolescent Psychiatry <\/div>\n
American Academy of Facial Plastic and Reconstructive Surgery <\/div>\n
American Academy of Family Physicians <\/div>\n
American Academy of Neurology <\/div>\n
American Academy of Otolaryngology-Head and Neck Surgery <\/div>\n
American Association of Clinical Endocrinologists <\/div>\n
American Association of Neurological Surgeons\/Congress of Neurological Surgeons <\/div>\n
American Association of Orthopaedic Surgeons <\/div>\n
American Association for Geriatric Psychiatry <\/div>\n
American College of Cardiology <\/div>\n
American College of Emergency Physicians <\/div>\n
American College of Radiology <\/div>\n
American College of Rheumatology <\/div>\n
American Geriatrics Society <\/div>\n
American Medical Association <\/div>\n
American Medical Directors Association <\/div>\n
American Podiatric Medical Association <\/div>\n
American Psychiatric Association <\/div>\n
American Society of Anesthesiologists <\/div>\n
American Society for Clinical Oncology <\/div>\n
American Society for Clinical Pathology <\/div>\n
American Society for Dermatologic Surgery Association <\/div>\n
American Society for Gastrointestinal Endoscopy <\/div>\n
American Society of Nephrology <\/div>\n
American Society of Nuclear Cardiology <\/div>\n
American Thoracic Society <\/div>\n
American Urological Association <\/div>\n
Endocrine Society, The <\/div>\n
Heart Rhythm Society <\/div>\n
Infectious Diseases Society of America <\/div>\n
International Society for the <\/div>\n
Advancement of Spine Surgery <\/div>\n
Medical Group Management Association <\/div>\n
Society for Vascular Surgery <\/div>\n
Arizona Medical Association <\/div>\n
California Medical Association <\/div>\n
Colorado Medical Society <\/div>\n
Connecticut State Medical Society <\/div>\n
Medical Society of Delaware <\/div>\n
Medical Society of the District of Columbia <\/div>\n
Florida Medical Association <\/div>\n
Medical Association of Georgia <\/div>\n
Hawaii Medical Association <\/div>\n
Illinois State Medical Society <\/div>\n
Iowa Medical Society <\/div>\n
Kansas Medical Society <\/div>\n
Kentucky Medical Association <\/div>\n
Louisiana State Medical Society <\/div>\n
Maine Medical Association <\/div>\n
MedChi, The Maryland State Medical Society <\/div>\n
Massachusetts Medical Society <\/div>\n
Michigan State Medical Society <\/div>\n
Minnesota Medical Association <\/div>\n
Mississippi State Medical Association <\/div>\n
Missouri State Medical Association <\/div>\n
Montana Medical Association <\/div>\n
Nebraska Medical Association <\/div>\n
Nevada State Medical Association <\/div>\n
New Hampshire Medical Society <\/div>\n
Medical Society of New Jersey <\/div>\n
New Mexico Medical Society <\/div>\n
Medical Society of the State of New York <\/div>\n
North Dakota Medical Association <\/div>\n
Ohio State Medical Association <\/div>\n
Oregon Medical Association <\/div>\n
Pennsylvania Medical Society <\/div>\n
South Carolina Medical Association <\/div>\n
South Dakota State Medical Association <\/div>\n
Tennessee Medical Association <\/div>\n
Texas Medical Association <\/div>\n
Vermont Medical Society <\/div>\n
Medical Society of Virginia <\/div>\n
Washington State Medical Association <\/div>\n
West Virginia State Medical Association <\/div>\n
Wyoming Medical Society <\/div>\n<\/td>\n<\/tr>\n<\/table>\n

The Sunshine Law requires acknowledging that industry is handing out articles they’ve selected that push their products and they don’t want to have to report what they are doing. Selective sunshine. So they get all of these medical societies to sign on to this letter. Why did they sign on? Why indeed! <\/p>\n

That’s the tragedy. They’re "bought men". Hang strong and let the sun shine in!…<\/div>\n","protected":false},"excerpt":{"rendered":"

From the letter in the last post… October 28, 2013 Secretary Kathleen Sebelius U.S. Department of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201 Dear Secretary Sebelius: The undersigned physician organizations representing both national medical societies and state medical societies are writing to express our serious concerns about the Center for Medicare […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-44517","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/44517","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/comments?post=44517"}],"version-history":[{"count":14,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/44517\/revisions"}],"predecessor-version":[{"id":44531,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/44517\/revisions\/44531"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=44517"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=44517"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=44517"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}