Latest Drugwonks' Blog
"Makers of dietary supplements looked to be on a collision course with Sen. John McCain when the Arizona Republican introduced legislation designed to strengthen policing of products marketed to casual and professional athletes." Yet, "the two sides appear to have reached a compromise they say will be part of a manager's amendment to a major food safety bill (S 510) being readied for Senate floor debate." Notably, "the provisions would require the Food and Drug Administration (FDA) to issue long-delayed guidance on acceptable supplement ingredients and report to the Drug Enforcement Administration when it rejects new supplements that contain synthetic anabolic steroids." This "would be a victory for McCain," who wanted the FDA to have more authority over supplements.
Talk about federal preemption!
CMS Medicaid confirmed Thursday that some money states receive as rebates from drugmakers will now be redirected to the federal government to help pay for the new health overhaul.
State officials had hoped the federal government would interpret the law in a way that left their discounts untouched. But in a letter Thursday to state Medicaid officials, CMS Services explained, "The amount of the savings resulting from the increases in the rebate percentages … will be remitted to the Federal government."
Cindy Mann, CMS director for the Center for Medicaid and State Operations , confirmed in an interview that meant states that already received drugmaker rebates between 15.1 and 23.1 percent would no longer be able to keep that portion of their savings. States and the federal government would continue to share in savings for the portion of the rebates both below and above that range. Many states already have average rebates well above 23 percent.
Mann suggested that state officials could negotiate deeper discounts with drugmakers to try to "recapture that dollar."
Thanks Cindy. Very helpful.
Teva is resigning from the Generic Pharmaceutical Association effective June 30th. (Apotex and Hospira resigned from GPhA last year.)
Does this make GPhA the healthcare equivalent of the Not Ready for Primetime Players?
Because Teva (Hebrew for "nature") most certainly is.
He has "retired" The Treatment but now reappears in TNR -- and elsewhere -- as a, hired hand or observer at large courtesy of the Kaiser Foundation which is now spending tens of millions to support Kaiser Health News. Or as the byline in Cohn's most recent TNR piece puts it: "This column is a collaboration between TNR and Kaiser Health News. KHN is an editorially independent news service and is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization, which is not affiliated with Kaiser Permanente."
Read Cohn's piece here
A collaboration? Does that mean KHN paid for Cohn to write the piece and TRN ran it? Did it split the costs? Did TNR pay for lunch? Is this something KHN will continue to do with other news outlets and magazines? Given the Kaiser Family Foundation's advocacy role and support of Obamacare, does this raise questions about media objectivity or should this be considered a novel way of funding reporting?
Kudos to Cohn and TNR for finding creative ways to carry on the health care discussion. Let's see if they and their followers are intellectually honest and consistent when folks like me follow suit.
To the Editor: In their Perspective article (Jan. 14 issue), Murray and Frenk review a number of indicators of the relatively poor state of the population's health in the United States. Most, if not all, of this information is well known to readers of the Journal, and the authors' use of it is not objectionable. However, Murray and Frenk begin their discussion by referring to the World Health Report 2000, Health Systems: Improving Performance, from the World Health Organization (WHO), which ranked the U.S. health care system 37th in the world, and this is objectionable. (I was editor-in-chief of the World Health Report 2000 but had no control over the rankings of health systems.) Fully 61% of the numbers that went into that ranking exercise were not observed but simply imputed from regressions based on as few as 30 actual estimates from among the 191 WHO member countries. Where the United States is concerned, data were available only for life expectancy and child survival, which together account for only 50% of the attainment measure. Moreover, the "responsiveness" component of attainment cannot be compared across countries, and the estimates of responsiveness for some countries were manipulated. This is not simply a problem of incomplete, inaccurate, or noncomparable data; there are also sound reasons to mistrust the conceptual framework behind the estimates, since it presupposes a production function for health system outcomes that depends only on a country's expenditure on health and its level of schooling, ignoring all cultural, geographic, and historical factors.
The number 37 is meaningless, but it continues to be cited, for four reasons. First, people would like to trust the WHO and presume that the organization must know what it is talking about. Second, very few people are aware of the reason why in this case that trust is misplaced, partly because the explanation was published 3 years after the report containing the ranking. Third, numbers confer a spurious precision, appealing even to people who have no idea where the numbers came from. Finally, those persons responsible for the number continue to peddle it anyway. To quote Wolfgang Pauli's dismissal of a theory opposed to quantum mechanics, "Not only is it not right, it's not even wrong!" Analyzing the failings of health systems can be valuable; making up rankings among them is not. It is long past time for this zombie number to disappear from circulation.
Philip Musgrove, Ph.D.
Health Affairs
Bethesda, MD
Much conversation about the FDA’s revised guidance on advisory committee conflict of interest waivers. Commissioner Hamburg wants a “stricter” policy.
Transparency? Certainly. But what exactly is the problem that requires stricter guidance? It’s not COI – its empty seats. 218 positions of the 600-plus on FDA's 49 advisory committees have yet to be filled.
According to the Pink Sheet, The general perception has been that the conflict-of-interest policy has made it more difficult to properly recruit for advisory committees. "There have been places where we felt we didn't have the right experts and we cancelled the meetings," John Jenkins, director of the Office of New Drugs, told attendees at the FDA/CMS Summit in December 2009 "We may have gone too far."
During my tenure at the FDA I was the senior official in charge of advisory committee oversight and the final decision-maker on who got a COI waiver and who did not. Many did not — but those who did received their waivers because FDA professional career staff made a strong case that these people weren’t just important to the advisory committee — but critical.
And we should all pay attention to the nomenclature. It’s not about “conflict of interest” – it’s about (as Secretary Sebelius correctly says) “interest.” And having an “interest” is not necessarily a bad thing – as long as you’re transparent about it.
http://www.space.com/entertainment/leonard-nimoy-retires-star-trek-100421.html
“Fail First” or “Succeed First?” It’s a pretty good proxy for the larger health care debate that pits short-term cost savings over long-term patient benefit.
A new bill in the California Assembly (AB 1826) addresses the issue of “fail first” policies (aka: “step therapy) and cuts right to the chase.
The bill “Requires a health plan or health insurer that covers prescription drug benefits to provide coverage for a drug that has been prescribed by a participating licensed health care provider for the treatment of pain without first requiring the enrollee or insured to use an alternative prescription drug or over-the-counter product.”
And it uses chronic pain as a specific example:
“Due to the variety of causal conditions and types of pain (acute and chronic), there is no standard treatment for pain. Pain treatment varies according to type, severity, and duration of pain, as well as the causal condition (if known), patient co-morbidities, and other factors (e.g., medication intolerance or patient compliance). Health care providers use clinical judgment to select among various pain medications and treatments in efforts to resolve or control pain for individual patients …For some enrollees, no pain medications are subject to fail-first protocols. Other enrollees, depending on the provisions of their plan contracts or insurance policies, have outpatient pharmacy benefits that make coverage for between one and 38 pain medications subject to fail-first protocols …Of more than 200 prescription medications used to treat pain, 54 are subject to fail-first protocols for at least some portion of enrollees with health insurance subject to this bill whose health insurance includes an outpatient pharmacy benefit.”
(The complete bill can be found here.)
One example of a group supporting this legislation is the California Medical Association. Opposed? The Association of California Life and Health Insurance Companies.
The repercussions of choosing short-term savings over long-term results, of cost-based choices over patient-centric care, of “fail first” policies over the right treatment for the right patient at the right time – are pernicious to both the public purse and the public health. Skimping on a more expensive medicine today but paying for an avoidable hospital stay later is a fool’s errand.
In California -- indeed across the entire United States -- access to care must be matched with quality of care.
On the 62nd anniversary of the founding of the Jewish state, a reminder of what David ben Gurion said regarding Israel's ability to thrive -- "to be a realist, one must believe in miracles." ( CMPI has been a proud partner of program based at the Tel Aviv University School of Management to support life science entrepreneurship in Israel for the past three years. “Health Care Technological Innovation - From Idea to Commercialization.” ) Israel's robust contribution to biomedical innovation -- despite the threat of terrorism and annihilation -- is truly miraculous:
According to the WEF 2007-2008 Competitiveness Report, Israel has the 5th highest number of patents pending in the world and ranks 3rd in technological readiness. Israel is ranked in 1st in the world for Medical Device Patents per capita, and ranks third in Europe for the number of clinical trials in progress.
Fourth in the world in biotechnology patents per capita, Israel not only has the talent to innovate, but the skills to transform technology into successful enterprise. A generous government incentives program is a major factor for pushing progress forward.
Entrepreneurship in Israel
Israel has the largest number of startups in the world per capita. In absolute numbers, Israel is only second to the US. Israeli startup companies are known for their creativity, innovation, and originality. Israeli ingenuity can be found in some of the world's leading products and technologies: voice mail, billing systems, internet security, instant messaging, ingestible video cameras, and generic pharmaceuticals.
Investments in Israel
Israel has the largest number of companies listed on the NASDAQ outside of the United States and approximately 70 Israeli companies are traded on various European exchanges.
According to the Israel Venture Capital Research Centre, Israel requires approximately $1.5 Billion of new investment annually to support its developing companies. Israel continues to attract capital both locally and from abroad. However, there continues to be a strong need to fuel the capital requirements of early-stage companies
Many major multi-nationals have chosen to run core activities in Israel including: HP, Microsoft, Intel, IBM, Siemens, GE, SAP, Philips, Time Warner, Sony, Cisco, Google, eBay, Analog Devices, Computer Associates, Berkshire-Hathaway, Applied Materials, Sun Microsystems, 3Com, Motorola, Pfizer, J&J and more.
Israel’s high tech industry in particular is extremely profitable and attractive to foreign multinationals.
2007 witnessed over 40 international Mergers & Acquisitions.
Mergers and Acquisitions in Israel
Major foreign firms have stepped up their local M&A activities, and direct foreign investment in Israel has exceeded $2 Billion annually.
2006 saw a record number of Mergers & Acquisitions - a total of 76 Israeli companies were acquired. Warren Buffet's Berkshire-Hathaway made its first international investment when the company made its monumental acquisition of Israeli ISCAR for $4 billion, HP acquired Mercury for $4.5 billion and SanDisk acquired M-Systems for $1.5 billion. Other examples of multinational companies that have acquired Israeli companies include: Microsoft, Motorola, Intel, HP, Siemens, Samsung, IBM, GE, Phillips, Lucent, AOL, J&J, Applied Materials, Sun Microsystems, EMC, Boston Scientific, eBay, HP, Kodak, Cisco and Xerox.
M&A activity involving Israeli companies that were either acquired or merged totaled $3.2 billion in 2007 in 75 deals – the second highest number of M&A deals in any one year to date.
Mergers and acquisitions of VC-backed Israeli companies in 2007 totaled $1.9 billion and consisted of 32 deals.
Venture Capital in Israel
With 100 active funds and over $10 billion under management, Israel’s venture capital industry thrives like in no other country. In 2004, foreign funds committed over 50% of the total dollars invested, demonstrating that Israel is an internationally sought after and sound investment (Israel ’s Ministry of Industry, Trade and Labor).
In the past 10 years, Israeli VC's attracted a total of $10.6 Billion. According to IVC, $2 Billion in capital is currently available for investment by Israeli VC's, of which $1.2 billion is intended for First investments in high-tech companies and the remainder reserved for Follow-on investments. $800 Million is expected to be raised in 2008 by Israeli VC's for investment in Israeli high technology over the next few years. (IVC Online)
In 2007, 462 Israeli high-tech companies raised $1.76 Billion from local and foreign venture investors, 8.5 percent above the $1.62 billion raised in 2006 and 31.5 percent above 2005 levels.
In the fourth quarter, 115 Israeli high-tech companies raised $503 million, a 21 percent increase from the $414 million raised by 108 companies in the third quarter and a 5 percent increase from Q4 2006. (IVC Online)
In 2007, Israeli VC's invested $678 million in Israeli high-tech companies. The Israeli VC share of the total amount invested in Israeli high-tech companies was 39 percent.
Israeli VC's invested $50 million in foreign companies during 2007 (in addition to their investments in Israeli high-tech companies), compared to $60 million in 2006 and $95 million in 2005. Three of the 39 investments were first investments and the remainders were follow-on.
In 2007, 78 Seed companies attracted $151 million, the highest amount raised since 2001.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
