Most of what I’ve read and previously written about electronic health records has been about making them work better or getting more clinicians to use them. Security of patients’ on-line data hasn’t been a major topic of concern. I’ve assumed that this was because these concerns had mostly been addressed back in the late 1990s during the development of the Health Insurance Portability and Accountability Act (HIPAA), or because those creating systems to allow medical information to be internet accessible – like those coalitions building dedicated Health Information Exchanges and companies like Microsoft, Google, and BlueCross BlueShield insurance plans – have resolved the security concerns.…
Cracking Down on Fake Cancer Cures
The FDA announced today that they have sent letters to 25 companies to stop selling fake cancer cures. That is, things that the companies claim cure cancer, but have never been tested, or approved by the FDA. The FDA has a web-site with more information about this, and a sub-page that lists 125 Fake Cancer Cures.
I know the FDA gets lots of flack for not doing enough – and not doing it fast enough – I applaud the FDA for taking this action, and encourage them to do more because I have found the advertisement and selling of these non-medicines troubling for a long time.…
Nature v. Nurture – Smoking and Other Complex Problems
A long-standing debate in the life sciences has been the role of nature versus nurture in determining individual characteristics. For example, how much of an individual’s height is determined by their genes and how much by their nutrition – both in childhood and prenatally?
In the last few decades advances in our understanding of genetics has shifted this dichotomy to describe it in terms of genetics versus environmental factors, and expanded our appreciation for the role nature/genetics play in causing all manner of human diseases. For example, it was discovered that genetically determined slow serotonin transporters in the brain can predispose individuals to developing depression.…
More Perspectives on Health Information Technology – Can We Call It Prevention?
A few weeks ago I wrote about the challenges of adopting electronic medical records to provide value for different stakeholders and the entire health care system. Well, this week the Congressional Budget Office released a paper on “Evidence on the Costs and Benefits of Health Information Technology.” This paper is a reasonable review and synthesis of the literature, but it’s important to recognize that the CBO’s mission is to focus on how federal legislation can change government spending.
While the paper concludes that savings from adopting HIT are generally uncertain, it does make some supportive comments about its value.…
Baseline and Goals of Treatment
While watching the Red Sox-Milwaukee baseball game on TV last Saturday, the announcers were discussing Julio Lugo, the Red Sox shortstop who had missed 5 games with a concussion. One of them noted that the team had done baseline neuroimaging testing on all the players so if they had a concussion during the season they would have a baseline to compare to their post-concussion tests. I assume that they also did non-imaging neurological testing, such as reflexes and memory, etc., and this was an extension of all the other evaluations the players went through.
The reason I found this interesting is that it highlights the importance of having an understanding of both a patient’s baseline and their goals.…
End of Life Issues: Clinical and Cost Considerations
At a policy related forum for medical residents at the Massachusetts General Hospital last week, one of the questions was about end of life care. The other panelists and I answered from a clinical perspective – and I also put a plug in for the Kenneth B. Schwartz Center which does educational programs for clinicians about strengthening patient-caregiver relationships and communications.
However, during the informal discussion after the panel, a number of the residents raised questions about how much of our healthcare spending goes for treating people at the end of life. In talking with them about this, I recalled three things having looked at this issue several years ago: First, there is a lot of public misunderstanding and misrepresentation of information about this topic.…
People in Clinical Trials: Patients or Subjects?
Are people who participate in clinical trials patients or subjects? This may seem like a minor rhetorical difference, but I believe it has tremendous implications for health and biomedical research policy. Let me explain why –
Clinical trials are experiments to discover new knowledge. Their intent is to see if a new way of treating a specific disease or condition is better than, the same as, or worse than, another option – either a placebo or an established treatment. Therefore, when people agree to participate in a clinical trial they are participating in this experiment, and their fundamental goal for participating should be to help future patients by expanding biomedical and/or clinical knowledge.…
Electronic Medical Records: Salvation or Sinkhole?
Electronic medical records (EMRs) have been touted as one of the solutions for healthcare’s cost and quality problems. But why haven’t we seen more benefits from EMRs?
Disconnect Between Costs and Benefits
The simple answer is that there is a disconnect between those who have to pay for EMRs and those who benefit from them. For example, many (if not most) national health reform proposals call for investing billions of dollars in EMR systems claiming that EMRs will save the healthcare system lots of money. However, these savings projections hide many important factors related to the timing of any potential savings, and how different stakeholders would be affected.…
The Stressed and Strained Health Care Workforce
The Institute of Medicine put out a report yesterday titled “Retooling for an Aging America: Building the Health Care Workforce.” The report discusses how the aging of the baby-boom generation will create greater needs for health care providers (of all types) who are trained in caring for the elderly with chronic conditions. The report’s recommendations fall into three categories: training, system transformation and financing. Like many reports about health system improvement, their recommendations all make sense – particularly within the context of the three categories. However, like many IOM reports, the writing by Committee process is a bit evident in that, (at least from the Executive Summary), it doesn’t seem to describe a complete plan, nor does it prioritize any of its recommendations – either in terms of funding or which actions should be done first.…
Information Can Change Medical Practice, Patient Behaviors, and Kill Kids
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.
Ensuring Enough Primary Care Clinicians
Like many complicated problems in the US healthcare system, setting a goal can be easy, but achieving it can be hard. In recent years there has been a number of proposals for increasing the use of primary care clinicians to help patients with chronic diseases (like diabetes) manage their care and avoid long-term complications – and to presumably lower long-term healthcare spending. For example, the “Patient Centered Medical Home” proposal supported by a dozen organizations, (including companies and family practice and pediatrics associations), doesn’t specifically use the term “primary care,” but it gets to the same result – heightened relationships and communications between patients and a particular clinician or clinic.…
More on Counterfeit Medicines & Safety
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.…