Monday, August 15, 2016

Another Limit of the Electronic Health Record

Do most people take the time to review their medical record? Of course not. In my case, what was supposed to be a tool to improve care missed the mark.

For 35 years I had the same internist. As he changed practices I went with him. Whether he was a preferred provider or not it was reassuring to know that he had my whole health history at his fingertips. He could flip through the decades of my health history and see the changes in my life. It was wonderful to feel the security inherent in the vision of continuity of care.

All that came to an abrupt stop when this past year my internist retired. I was all prepared to find a new internist when I realized it would be helpful to have a copy of my medical record. Imagine my surprise when I discovered that 31 years of my medical history were gone.  What had happened?

It seems that when my internist changed his practice to being part of MedStar my paper records did not go with him. MedStar was on an electronic system and the health record they had was only for the last four years he had been with them.  All previous paper records were not with MedStar. When I asked what happened to 31 years of my health record the MedStar person referred me to my internist’s former practice.

It seemed that while Medstar was willing to take the patients that came with the physician the paper health records of the patient were not welcome.
The situation became more problematic as I reviewed my electronic record.    There were diagnoses for conditions I never had and prescriptions that were never given.

My suggestion to everyone? Carefully review your medical record and keep a copy of it for yourself. The life you end up saving may be your own.

Monday, April 18, 2016

Rethinking Clinical Trials

Here is the link to my article that appeared today in El Mundo's (translation  below) supplement on innovation and technology (Innovadores). El Mundo is one of the most prestigious newspapers in Spain. 

Much has been said about the major discoveries that will change our lives. These range from treatments for cancer to those that change the course of the increasing number of rare and new diseases. Developing cures or treatments aligns with the business goal of developing a product or intervention that will improve lives and generate revenue for the innovator company. 

Given all the products that are in the discovery pipeline it is clear that companies want to develop new products that improve or enhance lives. And of course the product must be priced so that it is affordable; without sales there are no revenues. Unfortunately, too often in the discussion of the need to develop new treatments the arguments about price are at best myopic. One way to manage prices is to decrease the cost of drug development that according to industry estimates is about $1.2 to $1.3 billion. Advances in different fields like engineering, information technology, and telecommunications need to be applied to drug development.

Other opportunities lie in building new methodologies for clinical trials so that we know more precisely the characteristics of people who will benefit from the treatments that are in development. What we know is that the bulk of trials are based on models of drug and treatment development that ignore that health is very individualized.

There is much upbeat talk about the promise of precision medicine or personalized medicine but it will remain just talk as long as the clinical trials that underlie the development process continue to be structured in a way that is neither precise nor personalized. The innovator working with regulatory agencies has to rethink these critical aspects of development.

The use of animal studies has long been an essential part of basic research. Yet even in these often seminal efforts there have been huge omissions that effect everything from validity to reliability. Reardon [1]pointed out that, “In 2014, the NIH [United States National Institutes of Health] began requiring researchers to include female animals in studies, and giving out supplementary grants to those who complained about the cost." The omission of female animals was not good science.

Likewise factors that also effect outcomes in animal studies are what the animal has been fed and its living conditions.  Research indicates that variations in these conditions change the health and longevity of the animals, which impacts on the outcomes and the ability to replicate the research. Although leading experts indicate that animal studies are becoming less relevant we still often extrapolate from animals to humans.

When it comes to studies of people our failures to develop targeted treatments and interventions are compromised even further. To develop precision or personalized medicine clinical trials must at a minimum include and analyze information using race, ethnicity, and gender. These are characteristics that are essential to understanding the success or failure of treatments. The process will be enhanced as information about the individual’s genetic and microbiome become more available.

The solution is not to spend more money on larger clinical trials but to use the advances in all of the sciences and design trials that are better defined, that are inclusive, and carefully monitored. This will make it possible to develop medicines and treatments that meet the health needs of the individual, the revenue goals of the innovators, and most importantly, continue to support future discoveries to benefit us all.

[1] Reardon, S. "A mouse's house may ruin studies— Environmental factors lie behind many irreproducible rodent experiments." Nature. February 18, 2016 vol. 530 Pg. 254

Thursday, January 7, 2016

Sugar and the 2015-2020 Dietary Guidelines

We are all too familiar with sugar as a driver for diabetes and excess weight. Yang et al[1]  piled on even more data to raise our concerns about sugar when their research found that people who had more sugar in their diet were more likely to die sooner from cardiovascular disease.

So today when I listened to the Dietary Guidelines Stakeholders Briefing convened by USDA and DHHS I was very interested in the recommendations on sugar. I knew that in March 2015 the World Health Organization released a new guideline that recommended adults and children reduce their daily intake of free sugars to less than 10% of their total energy intake and that a further reduction to below 5% or roughly 25 grams (6 teaspoons) per day would provide additional health benefits.  I wanted to understand the rationale on deciding on the U.S. guideline of 10% instead of 5%. 

I was glad to be part of this briefing and liked the transparency of of being encouraged to type in our questions. As I typed in my question I could see the questions that others had asked and was looking forward to the answers about soy, caffeine, etc. When the moment for Q & A’s came up I was shocked that none of the questions that were posted were asked. I typed my question in again just in case someone had missed it…and still no response. I sent an email to and am still waiting for a response. A simple answer would be informative.  But I guess it is all related to why the 2015-2020 Dietary Guidelines were not released until 2016.

[1] Yang, Q., Zhang, Z., Gregg, E.W., Flanders, W., Merritt, R., Hu, F.B. “Added Sugar Intake and Cardiovascular Diseases Mortality Among US Adults,” JAMA Internal Medicine. 2014;174(4) Pgs. 516-524. doi:10.1001/jamainternmed.2013.13563.