Canada’s Proposal for Subsequent Entry Biologics

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After writing about Follow-On Biologics in a recent posting, I saw a notice about Health Canada’s proposal for how they would approve biologic products that are similar to already approved biologics whose patents have expired. They call these products Subsequent Entry Biologics (SEBs), and the proposal is open for public comment from March 14, 2008 until April 16, 2008.

While the draft guidance is lengthy, it does strike an overall well-balanced tone:

  • “SEBs are not ‘generic biologics'”
  • Approval of an SEB does not mean it can automatically be substituted for the original biologic that it is “similar” to
  • Comparative studies will be required to generate data showing similarity to the original biologic in terms of quality, safety and efficacy

In many ways, the draft guidance is similar (no pun intended) to the process the US FDA used to approve some generic drugs prior to the 1984 Hatch-Waxman Drug Price Competition and Patent Term Restoration Act.…

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More on Counterfeit Medicines & Safety

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My last post contained some perspectives about fake medicines. That same day, the LA times ran an article about California’s long-delayed pedigree requirements for tracking prescription medicines. This law was prompted by the discovery of fake medicines for HIV/AIDS in 2000, and was intended to achieve what the FDA has been trying to implement for many years.

The LA Times article blames the delays in the state’s drug tracking system on the industry – from the manufacturer to the retail pharmacy. I suspect that the real challenge is not in the technical or cost aspects from the manufacturers – who certainly have lots to gain by stopping counterfeits of their products from being sold instead of the real thing, but from the wholesalers and to a lesser extent the pharmacies.…

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Safety, Costs and Quality of Medicines

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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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Trans Fat Shocker

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A couple of days a week I work out of shared office space in Cambridge, MA that is part of a multi-floor incubator/start-up facility. One of the benefits in the office is the food stocked in the kitchens – including lots of healthy things, like fresh fruits, nuts, dried fruit, bagels, etc….. Now not all the food is purely healthy…. They have sodas and M&Ms, etc. But today I did a double-take, when I saw that the Drakes Apple FruitPies had 8 grams of Trans Fats per serving.

For those of you not familiar with Trans Fats, they are chemically created by taking naturally occurring oils and heating them in the presence of a metal catalyst (like nickel or platinum) to add extra hydrogens to the oil.…

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Culture of Healthcare Organizations

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Culture change is one of the core messages of a book I’m working on, so I was interested to see an article about “cultural transformation” in Modern Healthcare by John Mitchell, CEO of Harbor Community Hospital in WA.  He notes that there is frequently a disconnect between a hospital leader’s stated goal of wanting to create a great culture and their actions: Retaining a central command and control structure does not empower people, and forcing solutions onto hospital staff who feel uninspired to excel will not produce sustainable improvements. Rather cultural changes leading to improved quality and reduced costs requires the leader to inspire the staff to perform while also empowering them to achieve shared goals.…

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Boston University Biolab Update

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I don’t mean to keep harping on the BU biolab situation, but yesterday’s Boston Globe had a concise perspective on the situation. In that article, the attorney who sued to block the facility summarized the whole situation with the quote, “They should have taken the time before they spent a dime of the taxpayers’ money.” [In the context of the article, she clearly means that no money should have been spent on the building until the community’s safety concerns had been answered.]

I certainly agree.  The facility will most likely be worthwhile and will do important work related to serious diseases and possible bioterrorism agents, but in rushing to build and open it, the result is that it is costing more and actually take longer to complete because of the need to address the community’s concerns.…

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Principles for Health Reform & EBM

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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

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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 Evidence Based Medicine

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In a previous post I was somewhat critical of evidence-based medicine (EBM) when it is used to make payment decisions. One of the points I was trying to make is that EBM is not a passing fad. The staying power of EBM was recently reinforced by two recent developments.

First, the Medicare Payment Advisory Commission’s (MedPAC) March 2008 Report to Congress cites their own 2005 report recommending EBM as a touchstone for comparing physicians’ practices as one way to improve quality of care and value for the Medicare program:

In the March 2005 Report to the Congress, the Commission recommended that CMS measure physicians’ resource use over time and share the results with physicians (MedPAC 2005).

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More on BU Bio Lab – NIH Creates 2 Committees

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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?

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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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UK NHS Restricting Access to Uncovered Treatments

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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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