Information Can Change Medical Practice, Patient Behaviors, and Kill Kids

April 10, 2008 / Michael D. Miller MD / Clinician-Patient Relationships, Comparative Effectiveness, Delivery of Healthcare, FDA, Information & Communications, Public Health, Quality of Care & Safety / 1 Comment

Medical information can change how clinicians treat patients, how patients care for themselves, and how healthcare payers promote or prevent the use of treatments and diagnostic tests. However, this information can act as either a broad sword or a scalpel, and produce good or bad outcomes.

A recent report from a Canadian new service about an article from the Canadian Medical Association Journal describing the outcomes from warning about the use of anti-depressants in children brings this issue down from a general concept to being very specific. This news report stated:

Two years after Health Canada warned about prescribing anti-depressants to children, the number of children and teens who died by suicide increased 25 per cent after years of steady decline, major new Canadian research shows.

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Toxic Dietary Supplements

April 10, 2008 / Michael D. Miller MD / FDA, Nutrition, Public Health, Quality of Care & Safety / No Comments

I’m usually either supportive or neutral about alternative therapies because they generally aren’t harmful, and can be beneficial. However, there seem to be more and more recalls of these products by the Food and Drug Administration (FDA) for mislabelings that are significant, although seemingly not extremely dangerous.

On the other hand, I was struck by a press release I got yesterday from the FDA about a recall for the dietary supplement products “Total Body Formula” and “Total Body Mega Formula.” The recall was because these products had more than 200 times the amount of selenium than was printed on the products’ label – and the press release noted that, “Excessive intake of selenium is known to cause symptoms to include significant hair loss, muscle cramps, diarrhea, joint pain, fatigue, loss of finger nails and blistering skin.”…

More on Counterfeit Medicines & Safety

March 27, 2008 / Michael D. Miller MD / Access to Healthcare, Delivery of Healthcare, Economics & Financing, FDA, Information & Communications, Public Health, Quality of Care & Safety / No Comments

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.…

Safety, Costs and Quality of Medicines

March 25, 2008 / Michael D. Miller MD / Delivery of Healthcare, FDA, Politics, Public Health, Quality of Care & Safety, Therapeutic Substitution & Interchange / 1 Comment

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.…

Trans Fat Shocker

March 21, 2008 / Michael D. Miller MD / Nutrition, Public Health, Quality of Care & Safety / 2 Comments

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.…

Boston University Biolab Update

March 15, 2008 / Michael D. Miller MD / Information & Communications, Innovation, Public Health / No Comments

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.…

Vaccines and Autism – More Mess

March 11, 2008 / Michael D. Miller MD / Delivery of Healthcare, Innovation, Politics, Public Health, Quality of Care & Safety / No Comments

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

March 6, 2008 / Michael D. Miller MD / Information & Communications, Innovation, Politics, Public Health / No Comments

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.…

Health Groups Lobbying & Executives’ $$$s

February 19, 2008 / Michael D. Miller MD / Economics & Financing, Health Policy and Communications Blog, Nutrition, Politics, Public Health / 2 Comments

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.…

Level 4 Bio Lab at Boston University

February 1, 2008 / Michael D. Miller MD / Information & Communications, Innovation, Miscellaneous, Public Health / 1 Comment

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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