Boston University Biolab Update

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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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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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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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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Level 4 Bio Lab at Boston University

Today’s Boston Globe had another report about the delayed opening of the Level 4 research lab at Boston University.  Since it was first proposed and funded, this lab has raised controversy – primarily from those in the community who were concerned about the safety of research involving the most dangerous of organisms occurring in their urban neighborhood. While substantive process (and EPA) concerns have been raised during the building and certification of the lab, the problem really appears to have started from the beginning, with BU seeming to believe that all things biotech-science related are golden, and that their new lab would be welcomed into the neighborhood.…

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