New England Journal of Medicine and my article, "Beyond Diversity— Time for New Models of Health." It is all about leadership.

Although I had collected data for my dissertation in the US, Colombia, and Brazil, my committee told me not to use the word culture as culture was not a relevant variable. That was over 40 years ago. Fast forward to the summer of 2021 when I submitted an article to JAMA. One of the comments in the rejection was, "The section on cultural themes does not make sense."

It was not the first time I heard that comment so I submitted my article to New England Journal of Medicine (NEJM). The thoughtful editors had specific questions and very helpful, insightful suggestions. They accepted my article for publication and here is the link to the online version, "Beyond Diversity— Time for New Models of Health." The print version is in the New England Journal of Medicine, Volume 386:6, February 10, 2022, Pgs 503-505.

But this is not about my article, it is about how an institution and its leadership leads. NEJM is an example of leading through words and actions.  The closing sentence of NEJM's October 7, 2021 editorial "Striving for Diversity in Research Studies" clearly stated, "From this perspective, diversity in research isn't simply a matter of social justice. It's a critical part of learning how to improve the health of every person." NEJM's actions were to outline new requirements for future submissions for publication that included a supplementary table on the representativeness of study participants. Words and actions. 

I am hopeful that my article will be widely read and stimulate healthy discussions. Consultant driven solutions, e.g., an organizational theory of change, setting up DEI committees, or appointing a Chief Diversity Officer, may create activities but are rarely the solution for meaningful outcomes.

Change happens through leadership and that starts with each one of us.

More on Sadness, Depression, and COVID

 Just want to share my two recent articles on depression that were published in The Hill.

Sadness is not Depression

Holidays and Stress

COVID-19 Vaccine Trials Need to Be Based on Good Science

It is 2020 and we still have to remind the health care decision makers that data need to be collected, analyzed, and reported by race, ethnicity, and gender. The reason behind this push to have meaningful inclusion of diverse population is that it is good science; and, to not do so may have dangerous consequences. This is especially true for clinical trials as they are meant to provide information that is useful about anyone who will use it or take it. Here is our OpEd piece on COVID-19 vaccine clinical trials that appeared in The Hill.

Buena Salud® Guide on Understanding Depression and Enjoying Life

As COVID-19 began to change our way of life I knew that this would be a hard time for most people and that many people would need support. I wrote the first edition in 2011 and because of how the science has advanced and how our expectations have changed what started as an update ended up being 90% new plus 92 endnotes. 

Life has changed and what is needed is a combination of science, clinical insights, and the lessons learned from many others. There is much that we can do on our own to make our lives better and when we cannot do it alone...there are many options for treatment.

The book is available at Amazon and at your local bookstores. 

Here is the link for English edition and for the Spanish edition

COVID-19 Requires Hospital to Rethink The Patient Experience

Keeping patients and health care workers safe is more than cleaning surfaces and having people tested for COVID-19 four days before they come from a procedure. It also means thinking about exposure, viral load, and ventilation. The time a patient spends in a hospital or health care facilities must be minimized for the health of the patient and all those who work in a health care setting. Procedures need to be recalibrated in real time to take into account the changing realities of COVID-19. It is not about having to wait; it is about the extra time spent possibly being exposed or exposing others.

For example, it is unconscionable that Georgetown University Hospital asks patients to check-in 2 hours before they are taken in to start the prep-op for a procedure. Good management practices would find it unacceptable that the process should take 2 hours. In the case that I witnessed the process actually took less than 20 minutes but the patient had to be there 2 hours before and then ended up waiting an additional hour because the other procedures were delayed. Of course there is paperwork that needs to be done, but much of that can be, and is often accomplished by phone or online.

I contacted the hospital by email about my concerns. The “Patient Advocate” responded in a way that made clear that they were an advocate for the hospital. I eventually called Dr. Michael Sachtleben, President, MedStar Georgetown University Hospital and Dr. Lisa Boyle, Vice President of Medical Affairs kindly returned the call. I emphasized that especially now, under the current circumstances, 2 hours should be unacceptable to all. For certain what is required is timely action and not the process of a committee to agree that 2 hours is too long. The goal must be to reduce time spent in the hospital as much as possible. No excuses. Following pre-COVID-19 standard operating procedures is dangerous to some and fatal to others.

I will see if there is any change as I will be taking my patient back for a repeat procedure. 

The Evidence on Vitamin D is Clear

In August 2018 I wrote my first blog on Vitamin D and wondered how long it would take for clinical practice to change. Much more has been documented since then to move prescribers to rethink and change what they recommend.

On August 27, 2019 JAMA published an original investigation, “Effect of High-Dose Vitamin D Supplementation on Volumetric Bone Density and Bone Strength: A Randomized Clinical Trial.” The September 3, 2019 NEJM Journal Watch comments on the study were succinct, “In any case, the findings point to no benefit for bone integrity — and even potential harm — with high-dose vitamin D supplementation in patients whose vitamin D levels are adequate.”  

Even with critically ill patients the benefits were not evident. The December 26, 2019 NEJM original article “Early High-Dose Vitamin D3 for Critically Ill, Vitamin D–Deficient Patients” from The National Heart, Lung, and Blood Institute PETAL Clinical Trials Network concluded “Early administration of high-dose enteral vitamin D3 did not provide an advantage over placebo with respect to 90-day mortality or other, nonfatal outcomes among critically ill, vitamin D–deficient patients."

When it comes to recommending Vitamin D the willingness to change current prescribing behavior is still missing. The lag between the bench and clinical practice is not just a matter of communication; prescribers also have to be willing to change. 

High-fructose Corn Syrup (HFCS) and You

While the March 22, 2019  report in Science, "High-fructose corn syrup enhances intestinal tumor growth in mice," may need to be confirmed with humans, it is reasonable to expect that a similar effect will be found with people. At the very least each one of us who shops for food or beverages for ourselves and others should carefully read the ingredients that are listed on the label. And then what? When the product has HFCS...be proactive with your health and and the health of those you love and get something else.

Saving Money in Health Care

A good way to redirect the discussion on health care costs and savings is by reading our piece on clinical trials. We need to make sure that each person gets the medicines that we know will work for them. This is how to save lives and save money in our health care system.

Redo Recommendations Now: Vitamin D, Fake Data, and Hype

We all need Vitamin D, a hormone, but the challenge is in how to measure levels of Vitamin D, how to determine how much a person needs, and when necessary how to supplement it. Over the years it was difficult for me to reconcile how practically everyone I knew had a Vitamin D deficiency. Since we are not all part of one cohort and we are certainly a group that is diverse in many ways it seemed very odd that we all had the same deficiency.

An answer came in two recent articles. First and most concerning was the August 17, 2018 issue of Science article,"Tide of Lies— The researcher at the center of an epic scientific fraud remains an enigma to the scientists who exposed him."(DOI: 10.1126/science.361.6403.636). This analysis detailed that much of what we know about Vitamin D was based on Dr. Sato's fabricated studies. According to the article his work was "referenced more than 1,000 times, and 23 systematic reviews or meta-analyses have included one or more of the 12 trials." Second, on August 18, 2018 A Kaiser Health News investigation for The New York Times, "Vitamin D, the Sunshine Supplement, Has Shadowy Money Behind It," revealed the effect of one person on an entire field of practice.

Both are disturbing commentary on the state of our knowledge...and our sense of responsibility to one another. How fast will clinical practice change to take this fake data and hype into account? How long will it take to change the Recommendations for Vitamin D Supplementation, the Algorithms in medical decision making and AI, and all the other information that we give and have been giving. Given this evidence how do we answer the question, "Do I stop taking my Vitamin D?"

How Can We Do Better...

This has been a year of field research that evidenced that too often efforts to create a better situation ends up compromising a person's health and well-being. Here are three cases to consider.

Heathcare-associated Infections (HAIs)

Frank entered the hospital with pneumonia but upon returning home it seemed that while in the hospital he had contracted an infection of his foot. Several weeks later the infection was much worse and Frank was taken back to the hospital to determine how much of his leg would have to be amputated. There were no plans for rehab. 

In 2011 75,000 patients with HAIs died during their hospitalizations.

Best Practice

After Rosa’s stroke she was told that in order to prevent another stroke she needed to have the blockage in her artery cleared, i.e., carotid endarterectomy (CEA). Rosa knew the risks of the procedure but went through with it. Much to her disappointment, a few months later the blockage had reappeared. One year later she still has the blockage but no stroke.

Translational research is a step in the right direction but the continued lag from the bench (research) to the bedside (clinical practice) is unacceptable. At the same time evidence based medicine (EBM) continues to be undermined by the lack of inclusion and analysis by individual characteristics as well as the tendency of clinicians and insurers to apply a rigid set of procedures that are not nuanced to the person in front of you.

Defining Comfort

Agnes was having difficulty breathing and was taken to the hospital. Her initial diagnosis was pneumonia and a UTI; then, suddenly while at the hospital she had two heart attacks. Her family was told that (1) her heart had stopped working and was severely damaged, (2) there were no treatments available, and (3) diagnostic procedures that were invasive were not possible given her age and fragility. Agnes' family was also told that she would die that night in the ICU. Agnes's family decided that given the damage to her heart that "palliative or comfort" care was the best option for her. Somehow Agnes got through the night and after two more nights in the ICU Agnes was moved to a private room. The family was told she could not go home because the levels of oxygen given were higher than allowed in a home setting.

Comfort care what does that mean? How do we know?

Statement on CBO Estimates of Better Care Reconciliation Act

22 million people losing health insurance is unconscionable

“The CBO estimate of 22 million people losing health insurance should be a bill stopper.  This bill was supposed to increase the number of people who have health insurance.  As it stands the legislation is unconscionable,” said Jane L. Delgado, PhD, MS, President and CEO of the National Alliance for Hispanic Health, the nation’s leading Hispanic health advocacy group.

“It’s time for legislators to go back to the drafting table.  The American people deserve bipartisan legislation that will deliver on the promise of insurance for everybody.  Congress must (1) ensure access for people with pre-existing conditions instead of enacting barriers to access that may be a death sentence; (2) roll back Medicaid cuts and allow for rates of growth that reflect the reality of an aging population; (3) ensure an orderly transition that does not disrupt care and ensures states can respond to changes in a way that reduces cost growth without compromising quality and access; and, (4) strengthen and expand the network of community health centers that have a proven capacity to deliver quality services,” emphasized Dr. Delgado.

“The one thing that everybody agrees on is that our system is not perfect, so it is time to start working in a bipartisan fashion and serve the interests of the nation.  The American people deserve better,” concluded Dr. Delgado.

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About the National Alliance for Hispanic Health (The Alliance) 
The Alliance is the nation's foremost science-based source of information and trusted advocate for the best health outcomes for all. For more information, visit: http://www.healthyamericas.org or call the Alliance's Su Familia National Hispanic Family Health Helpline at 1-866-783-2645.

The New No Gimmick Diet— 
The Buena Salud® Guide to Losing Weight and Keeping It Off

I am thrilled by the review and recommendation by Redbook for the latest book in the Buena Salud® Series. You can order the book from Amazon in English or Spanish or through your local bookstore. Let me know what you think. The process of writing and living the book has been quite a journey.

The other books in the Buena Salud series include:
The Buena Salud® Guide for a Healthy Heart
The Buena Salud® Guide to Diabetes and Your Life
The Buena Salud® Guide to Arthritis & Your Life
The Buena Salud® Guide to Overcoming Depression and Enjoying Life

Considering Arthroscopic Surgery for Your Degenerative Knee Disease?

According to the most recent recommendations published in BMJ it seems that your answer should be,"No." The exceptions are young patients with sports-related injuries, patients with major trauma, and those with a true locked knee. This is a huge concern as according to the article 25% of people 50+ years old have degenerative knee disease. 

While a health care provider may be an expert on this procedure and may have been doing it for years...the time has come to rethink when to do it or have it done. The evidence is that in most cases arthroscopic surgery for degenerative knee disease does not produce the desired outcome.

There will be more research to come...in the meantime the challenge is to develop new interventions which are truly helpful. 

Back Pain

The data indicate that most people with back pain that lasts less than 12 weeks get better regardless of the treatment. Some people get better even without treatment. Taking all this into consideration as well as all the available evidence, the American College of Physicians recently published new guidelines for the treatment of back pain. This was the first revision since 2007 and what is recommended is a departure from past practice. 

There are surprises in the new guidelines, e.g., for acute back pain the recommendations include superficial heat, massage, and acupuncture. There are also very specific guidelines as to the medicines a person should take. Take a look at the recommendations and share them with a friend. 

The science behind wellness is growing. To make the best decisions for our health and the health of those we care for, we each need to know the latest science based information. 

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.

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. 

http://www.elmundo.es/economia/2016/04/15/5710e1aa468aebbb748b4624.html  

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

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 ASHMedia@hhs.gov 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.

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[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.

Myths We Love

Megan Scudellari’s, “Myths that will not die,” (Nature, Dec. 17, 2015 Vol. 528 pages 322-325) http://www.nature.com/news/the-science-myths-that-will-not-die-1.19022 focused on five myths: (1) screening saves lives for all types of cancer; (2) antioxidants are good and free radicals are bad; (3) humans have exceptionally large brains; (4) individuals learn best when taught in their preferred learning style; and, (5) the human population is growing exponentially.

Each statement had some initial evidence to support it but over time more research challenged the initial outcomes. What was compelling as I read the article was realizing that there were factors that seem to perpetuate if not strengthen a myth. These factors include a vocal community of supporters; the development of products, industries, and research lines to address or remedy the situation; and, attempts to discredit new research. As a result, myths like lies that are repeated, become accepted as truth. In the end the damage is done to all of us because rather than moving forward with science we are in a chokehold because of what others want us to believe.

As I look forward to 2016 and beyond, my hope is that as our knowledge grows we will use information wisely and change what we know and espouse. "Trust, but verify," should apply to much of what we do in health so that we can achieve the healthier and longer lives we all want.

Me and Burgers

I love hamburgers but lately I only eat them at home. I do not want to seem like a wuss but it seemed to me that when I ate burgers outside my home my microbiome let me know that they were displeased with my selection. Some of the people I know thought that I was just being picky when I said that I preferred meat that did not have added antibiotics or hormones.  Today's Washington Post made clear that my microbiome led me to a healthier choice.

Coca-Cola Funds Global Energy Balance Network

WHO is recommending limits in sugar intake because of the worldwide increase in people who have excess weight. Drinking one typical can of sugar sweetened beverage exceeds the limit. Nevertheless, it seems that Coca-Cola is interested in research that documents that excess weight is not due to bad diets but to not enough exercise http://nyti.ms/1KZUZ4e They just funded the Global Energy Balance Network to lead this work.