Latest Drugwonks' Blog
The European Court of Justice ruled on April 22 that financially incentivizing physicians to prescribe generic drugs (and to switch patients from branded medicines) is legal – but it remains illegal for innovator companies to engage in similar practices.
In its ruling, the ECJ said that EU legislation banning pharmaceutical companies from offering financial incentives to doctors does not prevent public health bodies, like UK Primary Care Trusts, from implementing schemes that offer doctors financial inducements for switching patients to a specific, named, medicine.
The switching of large numbers of patients in one area of the UK from a branded statin to generic simvastatin was believed to have been one of the triggers for the original court case, currently being heard in the UK High Court; it was this court that referred the questions decided by the ECJ in its ruling.
But, to understand the unintended consequences of such actions, it’s also imperative to consider what happens when such switching occurs. Case in point, The Health Improvement Network (THIN) study-- an observational study of a large United Kingdom primary care database showed that patients who were switched from established Lipitor therapy to generic simvastatin experienced a 30% increase in relative risk of cardiovascular events or death compared to patients who remained on Lipitor therapy.
The data, which included records from October 1997 to June 2005, were generated from a retrospective analysis of a medical database of anonymous patient records entered by general practitioners in the United Kingdom. The analysis included 11,520 patients (2,511 patients who had taken Lipitor for six months or more and were switched to simvastatin vs. 9,009 patients who were taking Lipitor for six months or more and then remained on Lipitor therapy).
While the reasons these patients were switched is not known -- it is certainly not inconceivable that it might have had something to do with ... short term costs to the system.
Now there will be another reason – direct payments.
And what of Article 94 of EU Directive 2001/83 which bans the practice. Specifically, "Where medicinal products are being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of medicine or pharmacy."
Do different rules apply to government incentives? In the EU it looks like this is just the case. Another lesson we need to learn as we move forward into the uncertain world of Uncle Sam, MD.
"While Berwick will be constrained by congressional directives and institutional rules, his large vision focuses on nothing less than revamping the delivery system from top to bottom. For example, when I interviewed him for my book Rx For Healthcare Reform, here’s how Berwick explained why he thought we could cut 30 to 40 percent out of healthcare spending without affecting quality:
The work of John Wennberg and Elliott Fisher at Dartmouth shows that the more intensive services are available in a community, the more that they’re used without effect on the quality of care. So supply drives demand. It’s a monster cost driver without value added.
This isn’t what most of the healthcare community (aside from primary care doctors) wants to hear. It isn’t what drug or device makers want to hear. And it’s a major reason why Republicans will oppose Berwick. But it is the message that all stakeholders need to absorb and take to heart if we really want to control costs and make good healthcare available to everyone."
http://industry.bnet.com/healthcare/10002286/berwicks-big-vision-will-make-him-target-in-bid-to-become-medicare-chief/
Meanwhile in the UK, Britain's Department of Health said investment in the NHS had risen from £35bn in 1997 to more than £110bn by 2011. That's over 200 percent, twice as fast as it did in the US. At the same time, UK oncologists note: "We now spend similar amounts to Europe on health generally and cancer care in particular, but less than two thirds of the European average on cancer drugs.... It just can't be that everybody else around the world is wrong about access to innovative cancer care and the NHS right in rationing it so severely."
No, it is also that UK cancer survival rates are still the lowest in Western Europe.
http://news.bbc.co.uk/2/hi/health/7579422.stm
Yes, "discipline" indeed.
Here's my take on Berwick's sweeping and silly assertions. Do we really want someone so driven by ideology and biased against our own healthcare system to head up CMS?
http://spectator.org/archives/2010/04/26/the-fix-is-in
Remember Richard Foster?
He’s the CMS official whose report on Part D costs were “suppressed” during the debate over the MMA. That was in 2003 – when he was a “whistle-blowing darling of Congressional Democrats.
That was then. This is now. Robert Pear reports that:
In signing the measure last month, President Obama said it would “bring down health care costs for families and businesses and governments.” But Mr. Foster said, “Overall national health expenditures under the health reform act would increase by a total of $311 billion,” or nine-tenths of 1 percent, compared with the amounts that would otherwise be spent from 2010 to 2019.
In his report, sent to Congress Thursday night, Mr. Foster said that some provisions of the law, including cutbacks in Medicare payments to health care providers and a tax on high-cost employer-sponsored coverage, would slow the growth of health costs. But he said the savings “would be more than offset through 2019 by the higher health expenditures resulting from the coverage expansions.”
Mr. Foster says the law will save Medicare more than $500 billion in the coming decade and will postpone exhaustion of the Medicare trust fund by 12 years, so it would run out of money in 2029, rather than 2017. In addition, he said, the reduction in the growth of Medicare will lead to lower premiums and co-payments for Medicare beneficiaries.
But, Mr. Foster said, these savings assume that the law will be carried out as written, and that may be an unrealistic assumption. The cuts, he said, “could become unsustainable” because they may drive some hospitals and nursing homes into the red, “possibly jeopardizing access to care for beneficiaries.”
Nancy-Ann DeParle, director of the White House Office of Health Reform, said that fear was unfounded.
“Unfounded.” That’s the counter-argument? Seems so. The White House is going to have to do better – a lot better. And remember – this story is from the pages of the New York Times – not the Washington Times.
The complete New York Times Story can be found here.
This will certainly add fuel to the fire of those calling for repeal.
But rather than repeal we should be talking “appeal” – like in appealing to the better angels of our nature. In other words -- being for something. And that something is called "the truth."
Let’s start a movement – and let’s call it “Appealism.” Here’s how it works: Rather than calling for “repeal” (which is a negative thing) let’s be for “appeal.” That means appealing to common sense and un-fuzzy math. It means calling a spade a spade and (most importantly) being honest.
I know – how naïve. But …
Even if the GOP realizes its most optimistic November projections, the likelihood for legislative repeal is still, well, a highly optimistic projection. And, even all the stars and planets align in an elephant-friendly fashion, there’s no scenario that provides for a two-thirds majority over-ride of a 100% predictable Presidential veto.
Hence, the need for “appeal.” The Foster analysis is a good place to start because the finish line isn’t repeal; it’s controlling the rule-making process. And that’s where “appeal” comes in.
Appealing to reality. Appealing to facts and figures rather than rhetoric and double-sided political coin of bribes and threats.
Appealism. Yes we can.
"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.
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.
