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Posts Tagged ‘American Medical Association’


8:50AM 11/12/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

8:50 a.m. – Keynote Speaker – CEO, American Medical Association

The American Medical Association (AMA) has the largest number of practicing physicians of all specialties as its members and the organization plays a very important role in health care policy and education of medical professionals.  AMA has been quite active in assessing the role of personalized medicine in the future of healthcare in all of its facets.  Dr. Madara will talk about the status of AMA’s thinking about personalized medicine and his vision of how it might be able to transform medical care.

Keynote Speaker

James Madara, M.D. @AmerMedicalAssn


Executive Vice President and CEO, American Medical Association

AMA Strategy the context for PM  – Outside looking in View applied

Mission statement: Promote Medicine 167 years since it was established. Societies of MDs – all population of American MDs, are members.

AMA developed:

  • CPT Curation – Billing of Procedures
  • Standard Procedure for Katrina and Emergency Medicine
  • Strategic Plan 110 active Projects to be compressed into three big ideas
  1. Connect clinics with community – OUTCOMES, cooperation with CDC i.e., Diabetes, HTN (KaiserPermanente)
  2. Medical education bring t to 21th century: Competence vs Time-in-Chair, 141 Medical Schools, teaching methods: Gaming/mobile, the lecture Hall in Medicine is poor form for education, Simulation methods, Clinical Research and Basic Research – blend across disciplines, platforms in Silicon Valley to create new TEACHING of MDs, Genomics must be incorporated, shifting from Inpatient to Outpatient to HOME, all training is for Inpatient – Nothing for HOME delivery of Care. 85% of all Medical School responded they need change in Teaching — 11 Excellence Medical Schools selected: Vanderbilt, MI, UCSF, UC Davis…
  3. Make practice of medicine joyous again – installation in MDs Offices, optimize the efficiency of MDs reporting now emphasis on USABILITY

Doing through Partnership: PM in Nutrition is everywhere — it is a HYPE, Gartner Group Hype Cycle was used by the Speaker for an analogy with Personalized Medicine (PM)

SHAKE out for a steady state in PM mitigation the hype

  • Mixed perceptions of Cost effectiveness of Healthcare delivery – Growth of Health Spending by Component:
  • Center on Outcomes and Values: PM redefined: away from behavioral toward procedural (actions): i.e, CV death risk predicted by waist size –

Cost/Behavior: sweet-spots are the following

  • Pharmaconeconomics: Is cost effective and it does not involve behavior
  • Cancer
  • Laboratory Developed Tests (LDTs)

– need be approved by FDA – New challenge in PM

– AMA View: Medical services not Medical Devices, CLIA ensure the quality and Standards, it requires more than guidance, currently FDA has ONLY guidance

 

 

– See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

 

@HarvardPMConf

#PMConf

@SachsAssociates

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ASHG to Maintain Information of to shut down National Genetics Coalition

Reporter: Aviva Lev-Ari, PhD, RN

 

National Genetics Coalition to Shut Down,

July 30, 2013

NEW YORK (GenomeWeb News) – The National Coalition for Health Professional Education in Genetics (NCHPEG), an interdisciplinary group of leaders from a range of public and private organizations funded by the National Institutes of Health, will shut down next month due to funding constraints, according to the National Human Genome Research Institute.

The genetics and genomics education information that NCHPEG has compileds and made available via its website will be maintained by the American Society of Human Genetics, ASHG executive VP and former NCHPEG executive director Joseph McInerney said.

NCHPEG launched in 1996 after current NIH Director Francis Collins and Kathy Hudson, current NIH director for science, outreach, and policy, began talking with the American Medical Association and the American Nurses Association about the need for educating healthcare providers about genetics and genomics. Those discussions led to the creation of the group, which has been funded by NHGRI, the National Center for Advancing Translational Sciences, the NIH Office of Rare Diseases, and several other government agencies and non-profit foundations.

NCHPEG is slated to close down on Aug. 31. When the coalition began, there were few applications for genomics-related applications in healthcare that doctors encountered.

“A lot has changed since then,” NCHPEG Executive Director Joan Scott said in a statement. “There are many more clinical applications of genomics available and a growing awareness within the healthcare provider community that they need to be thinking about incorporating them into practice. We see more institutions and organizations developing initiatives to bring genomics into the clinic.”

The coalition’s core aim has been to provide genetics and genomics professional education tools through partnerships with specific communities and collaborations.

To that end, it has developed a number of documents, products, and programs to provide core competencies and educational programs in genetics, genomics, and family history for healthcare professionals.

The group has developed special programs aimed at helping physicians recognize increased genetic risk for cancer, and helping nutritionists, physician’s assistants, dentists, nurses, and others understand genetics and genomics.

McInerney said that ASHG will work over the next six months to determine whether the society wants to become more deeply involved in offering educational programs to healthcare providers.

“But we have to be thoughtful. NCHPEG is closing as a direct result of the current funding climate. We have to determine where our funding for education programs would come from if our board decides to take this on,” he explained.

McInerney said that during his time at NCHPEG, the group distributed thousands of publications on genomics education.

“Our premise was that healthcare professionals want to be up-to-date on all areas of medicine. Many of them already felt like the field of genetics and genomics was snowballing and they wanted to be ready,” he said.

SOURCE

http://www.genomeweb.com//node/1259986?utm_source=SilverpopMailing&utm_medium=email&utm_campaign=Health%20Genetics%20Program%20to%20Shutter;%20Foundation%20Medicine%20Files%20for%20IPO;%20Intrexon%20Prices%20IPO;%20More%20-%2007/30/2013%2004:05:00%20PM

 

 

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Reporter: Aviva Lev-Ari, PhD, RN

Reform, Regulation, and Pharmaceuticals — The Kefauver–Harris Amendments at 50

Jeremy A. Greene, M.D., Ph.D., and Scott H. Podolsky, M.D.

N Engl J Med 2012; 367:1481-1483 October 18, 2012DOI: 10.1056/NEJMp1210007

 

Fifty years ago this month, President John F. Kennedy signed into law the Kefauver–Harris Amendments to the Federal Food, Drug, and Cosmetic Act (see photoPresident John F. Kennedy Signing the 1962 Kefauver–Harris Amendments.). With the stroke of a pen, a threadbare Food and Drug Administration (FDA) was given the authority to require proof of efficacy (rather than just safety) before approving a new drug — a move that laid the groundwork for the phased system of clinical trials that has since served as the infrastructure for the production of knowledge about therapeutics in this country. We often remember the Kefauver–Harris Amendments for the thalidomide scandal that drove their passage in 1962. But there is much we have collectively forgotten about Senator Estes Kefauver (D-TN) and his hearings on administered prices in the drug industry. Many parts of the bill left on Congress’s cutting-room floor in 1962 — and left out of our memories since — have not disappeared but continue to confront those who would ensure access to innovative, safe, efficacious, and affordable therapeutics.

By the time Kefauver began his investigation into the pharmaceutical industry in the late 1950s, the escalating expense of lifesaving prescription drugs was illustrating that the free-market approach to medical innovation had costs as well as benefits. From the development of insulin in the 1920s, through the “wonder drug” revolutions of sulfa drugs, steroids, antibiotics, tranquilizers, antipsychotics, and cardiovascular drugs in the ensuing decades, the American pharmaceutical industry had come to play a dominant role in the public understanding of medical science, the economics of patient care, and the rising politics of consumerism. For Kefauver, the “captivity” of the prescription-drug consumer in the face of price gouging and dubious claims of efficacy under-scored the need for the state to ensure that innovative industries worked to the benefit of the average American.

After 17 months of hearings, in which pharmaceutical executives were openly berated for profiteering and doctors were portrayed as dupes of pharmaceutical companies’ marketing departments, Kefauver presented his bill, S.1552. Perhaps its least controversial components were its calls for ensuring that the FDA review claims of efficacy before drug approval, monitor pharmaceutical advertising, and ensure that all drugs had readable generic names. More radically, Kefauver proposed completely overhauling the relationship between patents and therapeutic innovation. First, he proposed a compulsory licensing provision so that all important new drugs would generate competitive markets after 3 years. Second, and more controversial still, Kefauver wanted to eliminate “me-too drugs” and “molecular modifications” by insisting that a new drug be granted a patent only if it produced a therapeutic effect “significantly greater than that of the drug before modification.”1 Proving that a drug worked, according to Kefauver, was not enough: he wanted proof that a drug worked better than its predecessors. In contemporary terms, he wanted to know its comparative effectiveness.

Kefauver’s bill met strong resistance as it made its way through the Subcommittee on Antitrust and Monopoly.2 The American Medical Association firmly opposed the regulation of efficacy by a government agency, arguing that “the only possible final determination as to the efficacy and ultimate use of a drug is the extensive clinical use of that drug by large numbers of the medical profession over a long period of time.”3 The editors of the Journal, on the other hand, supported the efficacy provision and the expansion of generic drug names but opposed the patent provisions (considering them an “arbitrary discrimination” against the pharmaceutical industry) and the comparative effectiveness provisions (considering “proof of superiority” necessary only if superiority was actually being “claimed by the manufacturer”).4 The pharmaceutical industry amplified such concerns about comparative effectiveness, arguing that any a priori determination of which medicines were “me-too” and which were true innovations would be arbitrary. Efficacy was hard enough to prove, they suggested; proving comparative efficacy would be “completely impracticable.”3

Kefauver initially stuck to his guns on issues of compulsory licensing and patents, but his persistence ultimately cost him control of his own bill. In June of 1962, officials from the Kennedy administration and the pharmaceutical industry presented the subcommittee with an alternate bill — with no regulatory language about patents included. Kefauver cried foul, the Kennedy administration eased off its support, and S.1552 seemed to all observers to be a dead letter. It was only by chance timing that the summer of 1962 also produced a highly visible tragedy (thalidomide), a hero (Frances Kelsey), and enough ensuing public outcry to persuade Kefauver and Kennedy to embrace the gutted bill.

The amendments granted the FDA the power to demand proof of efficacy — in the form of “adequate and well-controlled investigations” — before approving a new drug for the U.S. market. They also led to a retrospective review of all drugs approved between 1938 and 1962 (the Drug Efficacy Study Implementation program), which by the early 1970s had categorized approximately 600 medicines as “ineffective” and forced their removal from the market. These market-making and unmaking powers were also tied to a new structure of knowledge generation: the orderly sequence of phase 1, phase 2, and phase 3 trials now seen as a natural part of any pharmaceutical life cycle.

However, a well-circulated grievance pointed to one unanticipated consequence of the amendments: the new burden of proof appeared to make the process of drug development both more expensive and much longer, leading to increasing drug prices and a “drug lag” in which innovative compounds reached markets in Europe long before they reached the U.S. market. Industry agitation surrounding the “drug lag” finally led to modification of the drug patenting system in the Drug Price Competition and Patent Term Restoration Act of 1984 — through further extension of drug patents. Indirectly, then, Kefauver’s amendments ultimately affected both pharmaceutical pricing and patenting — in a manner diametrically opposed to the one he intended.

Another unintended consequence of the amendments was that the new structures of proof changed not only the behavior of the pharmaceutical industry but also the conceptual categories used by biomedical researchers around the world.5 Pharmaceutical research came to be overwhelmingly organized around the placebo-controlled, randomized, controlled trial. Although this system has greatly helped researchers gauge the efficacy of an individual drug, it has also rendered data on comparative efficacy much more difficult — and much more expensive — to find or produce.

Renewed attention to comparative effectiveness research in the 21st century illustrates the consequences of sidelining Kefauver’s initial demand for comparative data for evaluating the promotion of novel therapeutics. By 2000, pharmaceutical expenditures had become one of the fastest-growing parts of the budget of many U.S. states and third-party insurers. But the kind of knowledge required for entry into the U.S. drug market offers consumers and payers little information relevant to choosing between subtly different “me-too” drugs within the same therapeutic class — whose therapeutic effect may or may not be the same. Only in the past decade, through the action of the Reforming States Group, the Drug Effectiveness Review Project, and most recently funding of comparative effectiveness research through the American Recovery and Reinvestment Act, the Affordable Care Act, and now the Patient-Centered Outcomes Research Institute, have we begun to catch up on the vital project of comparing therapeutics so that American consumers and their physicians can make meaningful treatment decisions — the project that motivated Kefauver’s original investigations a half century ago.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

SOURCE INFORMATION

From the Departments of Medicine and the History of Medicine, Johns Hopkins University School of Medicine, Baltimore (J.A.G.); and the Department of Global Health and Social Medicine, Harvard Medical School, and the Center for the History of Medicine, Francis Countway Library of Medicine — both in Boston (S.H.P.).

REFERENCES

  1. 1

    Congressional Record. Washington, DC: United States Senate, 1961;107:5639.

  2. 2

    Tobbell D. Pills, power, and policy: the struggle for drug reform in Cold War America and its consequences. Berkeley: University of California Press, 2012.

  3. 3

    Drug Industry Antitrust Act. 87th Congress, Session 1, 1961.

  4. 4

    Ethical drugs — reflections on the inquiry. N Engl J Med 1961;265:1015-1016
    Full Text | Web of Science

  5. 5

    Carpenter D. Reputation and power: organizational image and pharmaceutical regulation at the FDA. Princeton, NJ: Princeton University Press, 2010.

 

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