Safety, Costs and Quality of Medicines

I’ve been trying to figure out how to write something meaningful about the many reports over the last several months about the safety, costs and quality of medicines. I finally concluded that rather than a too lengthy blog post, a series of snapshots would create a good description of the situation – sort of like a slide show rather than a feature film:

Safety of Generic Drugs: A recent LA Times article discussed patients who had adverse reactions when switched from a brand name to a generic medicine. This article includes physicians’ experiences with several types of generic medicines, e.g. for epilepsy, depression, high blood pressure, irregular heart rhythms, and to prevent rejection of organ transplants.…

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Principles for Health Reform & EBM

The National Federation of Independent Businesses (NFIB), just launched their health reform campaign called Solutions Start Here. Their 10 small business principles for healthcare reform includes:

Evidence-based:
The healthcare system must encourage consumers and providers to accumulate evidence and to use that evidence to improve health. Appropriate treatment choices and better wellness and preventive care should be key outcomes.

Current information and decision systems make it difficult to accumulate, interpret and use evidence affecting treatment decisions. One result is overspending on treatments and underspending on prevention. Decision-makers must understand the impact of their decisions on both costs and outcomes. Such an understanding must be based on solid clinical and economic evidence.

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Vaccines and Autism – More Mess

There has been a lot reported in the news about the recent payment from the Federal Vaccine Injury Compensation Program for Hannah Poling, a girl who developed autism after being vaccinated. (See New York Times article and a Wall Street Journal blog report about this case.)

Amidst all the debate and news reporting there have been several connected and interesting facts:

  • The Federal program that is making the payment to the Poling family doesn’t concede that the payment is in any way an admission of a link between vaccines and autism.
  • Since most vaccines no longer contain the mercury containing preservative thimerosal, and yet the rate of new cases of autism hasn’t declined, it would seem that whatever arguments there were for a link between thimerosal and autism should have been settled.

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More on BU Bio Lab – NIH Creates 2 Committees

The NIH today announced that they are creating two groups to address public safety concerns about the P4 biolab being built at Boston University. The first group is an “internal Coordinating Committee. ” The second is an external “Blue Ribbon Panel” with 16 members (all physicians and/or scientists) – including Peggy Hamburg, MD, MPH – who I first met when we both worked on AIDS issues at the NIH. (Click here to see NIH press release with full list of Blue Ribbon Panel members.)

While creating these groups now seems reasonable, as I pointed out in my previous post, much of this effort and controversy could have been avoided if a greater investment had been made in developing relationships and buy-in from community stakeholder groups when the concept for the project was initiated.…

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Evidence Based Medicine – NICE or Nasty?

The US Medicare Payment Advisory Commission (MedPAC) recently released a report on “Creating a Center for Evidence-Based Medicine” that was prepared by an outside analysis group. Before dissecting the MedPAC report, let me just lay out some of the more controversial aspects of evidence-based medicine (EBM):

  • How are the results of EBM research used for coverage or payment?
  • Are the EBM conclusions based upon reviews of prior studies or on research done specifically for the EBM analyses?
  • Are the EBM conclusions relevant only for a clinical research situation, or do they reflect real-world practices?
  • All medical practices evolve and “best medical practices” are reflected last in textbooks…..

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E-Health – A Medical Information Miracle or Mess?

Information technology tools has been touted for years as a cornerstone for improving the quality of healthcare and reduce spending. While, clearly this has not been achieved, many e-health initiatives are being launched, and it is unclear how successful or efficient these will be. I am often concerned about the effect e-health systems have on the health care quality when my own physician spends so much time looking into and typing on his laptop. But to avoid discussing the challenges of e-health based upon my n of 1, below are 4 perspectives that are more expansive and analytical:

The Commonwealth Fund recently released a report about 27 state governments’ e-health activities in 2007.…

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UK NHS Restricting Access to Uncovered Treatments

A very interesting article in yesterday’s New York Times discusses how the National Health Service (NHS) in England is clamping down on patients using both their own money and the NHS services to get treatments for the same condition at the same time. The article primarily discusses the case of a woman with breast cancer where the NHS wouldn’t pay for Avastin, and told her if she paid for it herself, she would have to pay for all her medical treatments for breast cancer.

The article also discusses the complexity and apparent confusion within the medical community and the NHS about how this policy is supposed to be implemented.…

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NPR Story on Presidential Candidates’ Health Plans

I caught part of the report on NPR this morning about the Presidential candidates’ positions on healthcare. The gist of the story was that Clinton favors more extensive individual mandates than Obama (who only favors mandates to cover children), while McCain favors tax credits to make health insurance more affordable.

Whoever becomes the next President, something will clearly be different starting in 2009. Regardless of the candidates’ campaign/political statements, the next President’s actions on healthcare (unlike in foreign affairs), will largely depend on what they can negotiate with the next Congress – which seems like it will be more Democratic than it is currently, but probably not with 60 Senators to force votes on matters that the minority finds objectionable.…

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Health Groups Lobbying & Executives’ $$$s

The February 16th issue of National Journal has its biennial salary report (2006 data) for national advocacy and trade associations. Since most of my posts have been too long I’ll keep this one short with two (OK – actually three) interesting points:

First, in addition to salary information, National Journal reports on lobbying spending of various organizations. It’s not surprising that 3 of the top 10 trade associations [501(c)(6) organizations] in lobbying dollars are from the health industry: PhRMA, AMA, Am. Hosp. Assoc. But what is interesting, is that all of the top 5 non-profits [501(c)(3) organizations] in lobbying spending are health related organizations: Am.…

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Government’s Right & Left Hands

The US government issued two proposals last week that may seem to be a case of the right and left hands not knowing what the other is doing. In the first instance, the Food and Drug Administration (FDA) issued a proposal to allow bio-pharma and medical device companies to more easily distribute published articles that discuss uses not approved by the FDA. In the FDA’s press release discussing the “Good Reprint Practices” draft guidance, Randall Lutter, FDA deputy commissioner for policy, states that “Articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care,” and “This guidance also safeguards against off-label promotion.”…

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Technology and Health Care Costs

Peter Orszag, the Director of the Congressional Budget Office (CBO), recently testified before the Senate Budget Committee about increasing health care costs. One of his conclusions was that “the most important factor driving the long-term growth of health care costs has been the emergence, adoption, and widespread diffusion of new medical technologies and services by the U.S. health care system.”

His testimony concludes that by using “comparative effectiveness” research to “generate more information about the relative effectiveness of medical treatments and changing the incentives for providers and consumers,” would create a situation where “savings are possible without a substantial loss of clinical value.”…

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Medicare Cost Containment: Trigger & Physician 10.1% Cut

The end of the 2007 Congressional session included a battle about an automatic 10.1% reduction in Medicare reimbursements to physicians scheduled to start January 1st. The resolution to this battle was a temporary legislative fix with a 0.5% increase. However, that fix was only for 6 months, so on July 1st, reimbursements are scheduled to drop by 10.6% from what they are now – the original 10.1% plus the 0.5% increase.

While that will certainly be a focus for Congress this spring, there is another, bigger Medicare fiscal battle likely to be fought because of a provision of the 2003 Medicare Modernization Act (MMA).…

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