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At Home Genetic Testing

Monday, October 22, 2018 // Uncategorized

What is At-Home Genetic Testing?

Understanding what an at-home test will – and will not – tell you

For a price (typically several hundred to a thousand dollars) you can order a genetic testing kit online or by phone. You’ll swab your cheek or spit into a test tube. Then you will mail it to a lab where it may be tested for a wide variety of things — from whether you inherited your intolerance to the lactose in dairy products to your risk of certain types of cancer to if you carry a gene for a serious illness such as Cystic Fibrosis and could pass it on to your children.

There are at-home tests for:

  • Traits ( e.g., male hair loss to dimples)
  • Wellness (e.g.,  risk of certain types of cancer to restless leg syndrome)
  • Ancestry reports (i.e., ethnicity and lineage)
  • Carrier status (e.g., Tay-Sachs Disease to Sickle Cell Anemia)
  • Paternity testing (i.e., determining a child’s biological father)

There are three general ways to get genetic testing:

  • Through your physician or a genetic counselor – These are the most detailed and comprehensive tests available. They include cancer testing and testing for genetic disorders.  They include large “panels,” meaning they test for the most genes.
  • Physician-ordered online testing – While you can order some of the more comprehensive tests online, you will still need a physician’s approval. In some cases, your physician can order the test. In some cases, the testing company employs a physician who can order the test for you.
  • Direct-to-consumer testingThese are the at-home tests you most often hear about. They do not require a physician’s order. However, they don’t fall under the same guidelines as the other two types of testing, and they may provide incomplete information. For example, they may not test for the genes you’re most interested in. Or they provide you raw data, but don’t provide guidance regarding the results and what they may mean for you or your family.

Before you order at-home genetic testing, it’s important to consider your goals for testing. It’s also a good idea to understand what a test may or may not tell you, how reliable the testing is, and whether you will receive any guidance to help you understand what the test restuls mean for you and your family. If you’re thinking about at-home genetic testing, consider the following.

Is the company trustworthy?

If you decide to order an online test, research the company providing the service. Verify that:

  • The lab that conducts the tests has received one of the following certifications: Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP) or AABB. The Food and Drug Administration (FDA) is still exploring how it will address genetic testing and has approved some but not all such tests.
  • The company’s staff members have received extensive education in the subject, such as being certified genetic counselors, medical geneticists, pathologists, Ph.D. geneticists, biologists or molecular pathologists.

What will the test tell you, exactly?

It’s important to fully understand the test results. You should determine:

  • Exactly what is being tested (health conditions, ancestry, traits, carrier status)
  • How the results will be provided
  • What you will do with your results, and if they will help you make health decisions
  • If you might find out information you might not be expecting
  • If you plan to share your results with your family
  • If the company will contact you if there are new scientific findings that may change your results

Will your personal information be protected?

Carefully review the testing company’s privacy and security policy. Be sure to find out:

  • What does the company plan to do with your genetic information, now and in the future?
  • Will the company share your genetic information with pharmaceutical or biotechnology companies, researchers, not-for-profit groups or public or private DNA databases?
  • Will the company let you know if its policies change, or if your information is shared?

What professional help will the company provide?

No matter the results of your test, you likely will have questions. You should find out how the company plans to answer your questions.

  • Is a genetic counselor or other trained professional available before or after testing to provide guidance and help?
  • If so, is this service included in the cost of testing, or is there an extra charge?
  • Is the professional employed by the company, or is the service separate?
  • If the company does not have trained genetic professionals on staff, can it refer you to someone?

Receiving the results may produce a variety of emotions. You may be surprised, relieved, disappointed or confused. Whether you choose at-home testing or seek out testing through a medical professional, seeing a genetic counselor can provide helpful guidance.

Wishing you good health!

Mark L. Thornton, M.D.

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The New Shingles Vaccine

Monday, October 22, 2018 // Uncategorized


The short version: As many of you know, a new shingles vaccine (“SHINGRIX”) was introduced in the past year, and is recommended for all adults over 50 years of age. The new vaccine is much more effective than the old vaccine (“Zostavax”). The new vaccine is associated with a higher incidence of side effects (such as pain and swelling at the injection site, or flu-like symptoms—achiness, fatigue—typically lasting a day or two after the vaccine), but because of its improved effectiveness, SHINGRIX has essentially replaced the old shingles vaccine.  More detailed information from The Medical Letter follows: 

The long version:

The FDA has approved an adjuvanted, recombinant varicella zoster virus (VZV) vaccine (Shingrix – GSK) for prevention of herpes zoster (shingles) in adults ≥50 years old. Shingrix is the second herpes zoster vaccine to be approved in the US; Zostavax, a live-attenuated VZV vaccine approved for the same indication, has been available since 2006.1,2

HERPES ZOSTER – Following primary infection, VZV persists in a latent form in sensory ganglia; VZV-specific cell-mediated immunity (CMI) prevents reactivation and multiplication of latent virus. When CMI falls below a critical threshold, as it can in older and immunocompromised persons, VZV can reactivate, causing shingles and, occasionally, postherpetic neuralgia (PHN) and other complications. About 1 million cases of shingles occur in the US each year.3,4  

ZOSTAVAX  In clinical trials, the live-attenuated vaccine significantly reduced the incidence and severity of herpes zoster and PHN in adults ≥50 years old, but its effectiveness declines sharply with age (see Table 1), and its protection against shingles wanes to 4% within 8 years after inoculation in persons vaccinated at ≥60 years old.5-9 Zostavax is contraindicated for use in immunocompromised patients and it must be frozen during storage and transport. The Advisory Committee on Immunization Practices (ACIP) recommends Zostavax only for adults ≥60 years old, even though it was approved by the FDA for use in those ≥50 years old.10

SHINGRIX  The new recombinant vaccine contains a surface VZV glycoprotein E (gE) antigen obtained from cultured, genetically engineered Chinese hamster ovary cells that triggers a targeted immune response to VZV. It also contains a liposomal adjuvant (AS01B) to enhance the immune response. Unlike ZostavaxShingrix is not contraindicated for use in immunocompromised patients and does not need to be frozen during storage and transport.

CLINICAL STUDIES – FDA approval of Shingrix was based on the results of two observer-blind trials, one in adults ≥50 years old and the other in adults ≥70 years old, in which a total of 27,922 persons were randomized to receive two doses of vaccine or placebo two months apart.11,12 The vaccine was effective in preventing herpes zoster and PHN in all age groups. Pooled results of the trials are summarized in Table 1.

The duration of protective immunity against shingles with Shingrix is unknown. In persons ≥70 years old, vaccine efficacy was 85.1% in the fourth year after vaccination.12 Immunogenicity data suggest that the protective effect of Shingrix will persist for at least 9 years after vaccination.13 The efficacy of Shingrix in persons who receive only one dose is not known. Shingrix and Zostavax have not been compared in head-to-head trials.

ADVERSE EFFECTS — Although not directly compared to one another in clinical trials, adverse reactions appear to occur more often with Shingrix than with Zostavax. Common adverse effects of the new vaccine include myalgia (45%), fatigue (45%), headache (38%), shivering (27%), fever (21%), GI symptoms (17%), and injection-site pain (78%), redness (38%), and swelling (26%). Severe local reactions preventing normal daily activities occurred in 17% of persons who received Shingrix and persisted for a mean of 2 days. Serious adverse events, including new-onset immune-mediated disease and death, occurred at similar rates in the vaccine and placebo groups. Long-term data on the safety of Shingrix are lacking.

DRUG INTERACTIONS – The efficacy of Shingrix may be reduced in patients who are receiving immunosuppressive therapy.

DOSAGE AND ADMINISTRATION – Shingrix should be given as two 0.5-mL doses administered intramuscularly 2-6 months apart. It can be given at the same time as influenza vaccine, but a different injection site should be used.

The vaccine is supplied in two single-dose vials, one containing the lyophilized antigen component and the other containing the adjuvant suspension component. Both vials should be refrigerated during storage; the vaccine should be discarded if frozen. Before administration, the antigen component must be reconstituted with the adjuvant component to form an opalescent, colorless to pale-brown liquid. The reconstituted vaccine should either be administered immediately or refrigerated and given within 6 hours. It should be discarded if it appears discolored or contains visible particulates.

NEW RECOMMENDATIONS – The ACIP now recommends that healthy adults ≥50 years old, including those who have already received Zostavax, be vaccinated with two doses of Shingrix (2-6 months apart).10 The committee voted that Shingrix is preferred over Zostavax for herpes zoster prevention. The optimal time between administration of Zostavax and vaccination with Shingrix has not been established.

Update 1/26/18: Since publication, the ACIP has recommended that Shingrix not be given <2 months after vaccination with Zostavax.14

CONCLUSION – The adjuvanted, recombinant varicella zoster virus (VZV) vaccine (Shingrix) appears to be considerably more effective than the live-attenuated VZV vaccine (Zostavax) for prevention of herpes zoster (shingles), especially in older patients. Two doses of Shingrix administered 2-6 months apart are now recommended for healthy adults ≥50 years old, including those who have previously received Zostavax. Ensuring completion of the two-dose series may be challenging, particularly in patients who experience severe adverse effects with the first dose.

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New Medicine/Old Medicine

Sunday, January 15, 2017 // Uncategorized

I haven’t blogged for awhile.  I haven’t been inspired.  Now I have just finished my  notes for Friday. It was a busy day and I left the office before I had finished all my documentation.  That happens often.  I get home and I spend another hour finishing notes.  This is the way it is with many doctors.  We want the record to reflect something of the patient encounter.  Too often, it is just documenting for reimbursement.  It’s about checking all the boxes necessary to meet certain core measures.  This article in The Annals of Internal Medicine’s section On Being a Doctor  captured the sense of  an older physician’s struggle to take care of patients while  teaching what medicine used to be like.

On Being a Doctor |6 December 2016

Coeur d’Alene

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Flu Shot Today? Later May Be Better Than Sooner

Sunday, September 18, 2016 // Uncategorized

This article is from Kaiser Health News.  It also was mentioned on NPR and The Rivard Report.  We’re still waiting on our quadrivalent vaccine to come in.  The pharmacies are 600 pound gorillas and get theirs first.  As this article mentions, it is best not to rush out and get it.

The Ads Say ‘Get Your Flu Shot Today,’ But It May Be Wiser To Wait

September 15, 2016

flu shot sign

The pharmacy chain pitches started in August: Come in and get your flu shot.

Convenience is touted. So are incentives: CVS offers a 20-percent-off shopping pass for everyone who gets a shot, while Walgreens donates toward international vaccination efforts.

The start of flu season is still weeks — if not months — away. Yet marketing of the vaccine has become an almost year-round effort, beginning when the shots become available in August and hyped as long as the supply lasts, often into April or May.

Not that long ago, most flu-shot campaigns started as the leaves began to turn in October. But the rise of retail medical clinics inside drug stores over the past decade — and state laws allowing pharmacists to give vaccinations — has stretched the flu-shot season.

The stores have figured out how “to deliver medical services in an on-demand way” which appeals to customers, particularly millennials, said Tom Charland, founder and CEO of Merchant Medicine, which tracks the walk-in clinic industry. “It’s a way to get people into the store to buy other things.”

But some experts say the marketing may be overtaking medical wisdom since it’s unclear how long the immunity imparted by the vaccine lasts, particularly in older people.

Federal health officials say it’s better to get the shot whenever you can. An early flu shot is better than no flu shot at all. But the science is mixed when it comes to how long a flu shot promoted and given during the waning days of summer will provide optimal protection, especially because flu season generally peaks in mid-winter or beyond. Experts are divided on how patients should respond to such offers.

“If you’re over 65, don’t get the flu vaccine in September. Or August. It’s a marketing scheme,” said Laura Haynes, an immunologist at the University of Connecticut Center on Aging.

That’s because a combination of factors makes it more difficult for the immune systems of people older than age 65 to respond to the vaccination in the first place. And its protective effects may wear off faster for this age group than it does for young people.

When is the best time to vaccinate? It’s a question even doctors have.

“Should I wait until October or November to vaccinate my elderly or medically frail patients?” That’s one of the queries on the website of the board that advises the Centers for Disease Control and Prevention on immunizations. The answer is that it is safe to make the shots available to all age groups when the vaccine becomes available, although it does include a caution.

The board says antibodies created by the vaccine decline in the months following vaccination “primarily affecting persons age 65 and older,” citing a study done during the 2011-2012 flu season. Still, while “delaying vaccination might permit greater immunity later in the season,” the CDC notes that “deferral could result in missed opportunities to vaccinate.”

How long will the immunity last?

“The data are very mixed,” said John J. Treanor, a vaccine expert at the University of Rochester medical school. Some studies suggest vaccines lose some protectiveness during the course of a single flu season. Flu activity generally starts in the fall, but peaks in January or February and can run into the spring.

“So some might worry that if [they] got vaccinated very early and flu didn’t show up until very late, it might not work as well,” he said.

But other studies “show you still have protection from the shot you got last year if it’s a year when the strains didn’t change,” Treanor said.

In any given flu season, vaccine effectiveness varies. One factor is how well the vaccines match the virus that is actually prevalent. Other factors influencing effectiveness include the age and general health of the recipient. In the overall population, the CDC says studies show vaccines can reduce the risk of flu by about 50 to 60 percent when the vaccines are well matched.

Health officials say it’s especially important to vaccinate children because they often spread the disease, are better able to develop antibodies from the vaccines and, if they don’t get sick, they won’t expose grandma and grandpa. While most people who get the flu recover, it is a serious disease responsible for many deaths each year, particularly among older adults and young children. Influenza’s intensity varies annually, with the CDC saying deaths associated with the flu have ranged from about 3,300 a year to 49,000 during the past 31 seasons.

To develop vaccines, manufacturers and scientists study what’s circulating in the Southern Hemisphere during its winter, which is our summer. Then — based on that evidence — forecast what flu strains might circulate here to make vaccines that are generally delivered in late July.

For the upcoming season, the vaccines will include three or four strains, including two A strains, an H1N1 and an H3N2, as well as one or two B strains, according to the CDC. It recommends that everyone older than 6 months get vaccinated, unless they have health conditions that would prevent it.

The vaccines can’t give a person the flu because the virus is killed before it’s included in the shot. This year, the nasal vaccine is not recommended for use, as studies showed it was not effective during several of the past flu seasons.

But when to go?

“The ideal time is between Halloween and Thanksgiving,” said Haynes at UConn. “If you can’t wait and the only chance is to get it in September, then go ahead and get it. It’s best to get it early rather than not at all.”

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Fats, Fat and Death

Sunday, July 24, 2016 // Uncategorized

Here are a couple of recent articles dealing with the type of a fat in the diet and mortality and obesity and mortality.

Being Modestly Overweight Linked to Increased All-Cause Mortality Risk

By Amy Orciari Herman

Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, FASAM

Being even modestly overweight is associated with increased mortality risk, according to a large meta-analysis in the Lancet. The finding calls into question prior research suggesting that a slightly elevated body-mass index might be protective.

Researchers examined individual participant data from 189 studies comprising nearly four million adults who had never smoked, had no known chronic conditions at baseline, and survived beyond 5 years of follow-up. Participants were from North America, Europe, Australia, and East Asia.

Overall, roughly 386,000 participants died. All-cause mortality was lowest at a BMI of 20.0–24.9 (normal weight) and then increased significantly and linearly beginning at a BMI of 25.0–27.4 (hazard ratio, 1.07). BMIs below 20.0 also posed increased risk. The findings were consistent across geographic regions, and associations between higher BMIs and mortality were greater in younger than older participants and in men than in women.

The authors write, “These findings suggest that if the overweight and obese population had WHO-defined normal levels of BMI, the proportion of premature deaths that could be avoided would be about one in five in North America.”

Dr. Harlan Krumholz of NEJM Journal Watch Cardiology commented: “What I really want to know is not average risk, but who has the most risk, if any, among those who are modestly overweight. Meanwhile, as a physician, my greatest emphasis regarding weight loss will remain on those with marked elevation of BMI, those with the highest risk.”

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Overuse of Antibiotics

Thursday, May 5, 2016 // Uncategorized

Antibiotics are often prescribed for upper respiratory tract infections inappropriately.  According to the most recent study, 1/3 of antibiotics are prescribed inappropriately.  Overuse of antibiotics leads to resistance of bacteria.  Here is a summary of a recent JAMA article from Physicians First Watch.  Following that is the American College of Physicians informational page for patients on appropriate antibiotic use.

May 5, 2016 Population-Based Estimates of Appropriate and Inappropriate Antibiotic Prescribing Thomas L. Schwenk, MD reviewing Fleming-Dutra KE et al. JAMA 2016 May 3. Tamma PD and Cosgrove SE. JAMA 2016 May 3. Thomas L. Schwenk, MDThe U.S. annual antibiotic prescribing rate in 2010 was about 500 prescriptions per 1000 people; one third of prescriptions were judged to be inappropriate. Thomas L. Schwenk, MDResearch about inappropriate antibiotic prescribing usually focuses on specific conditions and age groups. However, these researchers used several national ambulatory care databases to provide overall population-based estimates that could guide government and professional mandates designed to reduce inappropriate antibiotic prescribing.Researchers assessed appropriateness of antibiotic use in about 184,000 ambulatory visits (not including urgent care centers, “minute” clinics, federal facilities, or long-term care facilities) in 2010 and 2011 using accepted clinical practice guidelines. If guidelines were not available (e.g., for sinusitis), the lowest regional level of antibiotic use was used as a surrogate for appropriateness (almost certainly still an overestimate). For some conditions (e.g., pneumonia), all antibiotic use was deemed to be appropriate.The overall annual rate of antibiotic use was 506 prescriptions per 1000 people, of which roughly two thirds of prescriptions (353 prescriptions/1000 people) were deemed to be appropriate. The overall rate ranged from 423 to 553 prescriptions per 1000 people in the West and South, respectively. Most inappropriate antibiotic use was for acute respiratory conditions (111 prescriptions/1000 people annually).Comment – See more at:

Appropriate Antibiotic Use for Acute Respiratory Tract Infection in Adults: Advice for High-Value Care From the American College of Physicians and the Centers for Disease Control and Prevention

 What are acute respiratory tract infections?

Acute respiratory tract infections (ARTIs) are common in adults. ARTIs include bronchitis, sinus infections, sore throat, and the common cold. Most are caused by a virus, not by bacteria.

What are harms related to antibiotic use?

Antibiotics are medicines used to treat illnesses that are caused by bacteria, such as strep throat (medical name: group A streptococcal pharyngitis) or pneumonia. Antibiotics will not work for illnesses caused by viruses, such as the common cold. Antibiotics can cause harm when they are not used the right way. These harms can include:

Side effects: These can be mild, such as upset stomach, diarrhea, or skin rash. However, in some cases they can be very serious and even life-threatening.

High costs: Prescriptions that are not needed increase patients’ out-of-pocket costs. It is estimated that 50% of antibiotic prescriptions are not needed, totaling more than $3 billion in wasted spending.

Antibiotic resistance: When antibiotics are used when they are not needed, germs and bacteria can become resistant to them. This means that common antibiotics will not be able to treat certain illnesses. Antibiotic-resistant bacteria cause more serious illnesses that are harder to cure and can be life-threatening.

Why are so many people prescribed antibiotics when they are not needed?

Because antibiotics have often been used when not needed, many patients expect to receive antibiotics for ARTIs and believe that they need them to feel better. In other cases, clinicians may prescribe antibiotics right away, rather than waiting or testing to see if they are needed.

How did the ACP develop this advice?

The authors looked at research and clinical guidelines related to antibiotic use for ARTIs. This information was used to develop advice for clinicians and patients.

What does the ACP recommend that patients and physicians do?

Reducing unneeded antibiotic prescribing will improve care, lower costs, and help to stop antibiotic resistance. In most patients, symptoms get better in 1 to 2 weeks. Coughs can sometimes last up to 6 weeks. The ACP recommends the following:

•Clinicians should not prescribe antibiotics for patients with bronchitis. Antibiotics should only be used if patients have pneumonia.

•Clinicians should test patients with symptoms that could be strep throat. Because symptoms alone are not reliable, antibiotics should only be prescribed when testing confirms strep throat. Other sore throat infections do not need antibiotics.

•Clinicians should not prescribe antibiotics for sinus infections unless patients have severe symptoms or symptoms that last more than 10 days. Patients whose symptoms improve but eventually get worse may also need antibiotics.

•Clinicians should not prescribe antibiotics for patients with the common cold.

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The Benefits of Quitting Smoking

Wednesday, March 2, 2016 // Uncategorized

It’s never too late.  From a recent review article on smoking cessation from the Annals of Internal Medicine. Even patients who have lung cancer have an average survival that is longer in those who quit smoking than those who continue to smoke.

The benefits of quitting begin immediately and last for decades. After 10 years of smoking cessation, the risk for lung cancer in former smokers was reduced up to 50% (1). Smoking cessation reduces risk for death from CAD by two thirds within 2–3 years of quitting, with risk approaching that of persons who have never smoked (12, 13). Circulation improves within weeks of quitting, and stroke risk is reduced to the level of that of nonsmokers in 2–4 years (14). Lung function improves within 3 months. Smoking cessation during the first 3–4 months of pregnancy reduces risk for low birthweight to that of never-smokers. Other benefits include reduced damaging effects on skin, breath, teeth and gums, smell, and taste. Finally, smokers and providers should be aware that tobacco use can affect metabolism of caffeine and commonly prescribed medications, including olanzapine, clozapine, and theophylline (15). Therefore, when smokers successfully quit, medication doses might be lowered.

Health Benefits of Quitting Tobacco

Symptoms: Minutes–days: Lower BP; lower carbon monoxide; better stamina, smell, tasteLung function

  • 2–4 weeks: Decreased respiratory infections

  • 4–12 weeks: Improved lung function

Cardiovascular disease

  • 2–3 months: Improved circulation

  • 1 year: 50% reduction for heart attack

  • 5–15 years: Cardiovascular risk equals that of never-smokers

Cancer: 10 years: Risk for lung cancer reduced by half

Is there an age after which smoking cessation no longer yields benefit?
Smoking cessation benefits people of all ages, regardless of smoking history (6, 7). Older smokers, despite smoking for many years, may have increased motivation from health concerns and symptoms of tobacco-related illness, experience with what has been successful in past quit attempts, and better access to treatment resources.
Two large, recent, retrospective cohort analyses showed that smokers who quit at age 55–64 years gained 4 years of life and that even those who quit after age 70 years had lower risk for mortality than those who continued to smoke (6, 7).
Clinical Bottom Line: Health Consequences of Smoking
Tobacco use affects nearly every organ system in the body and leads to numerous disorders, including heart disease, stroke, many types of cancer, vascular disease, respiratory infections, diabetes, and gastroesophageal reflux disease. The health benefits of quitting start within minutes and continue for years. These risk-reduction benefits are especially significant for smokers with CAD, COPD, or those who are pregnant by reducing preterm labor and low birthweight. Cessation for smokers with children can reduce exposure to and disease caused by environmental tobacco smoke. Even after decades of smoking, those who stop smoking significantly reduce their risk for death from certain diseases, such as lung cancer, and slow the deterioration of lung function in patients with COPD. One is never too old or young, too healthy or sick, to benefit from smoking cessation.
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“I Heard This on TV….”

Tuesday, February 23, 2016 // Uncategorized

We are constantly bombarded with medical news. It is part of the fodder of the news media.  The problem with this is that information is not all of the same caliber. It doesn’t all carry the same weight. Case in point, a recent study showed and association between proton pump inhibitors like Nexium and chronic kidney disease.  This is a summary from Journal Watch.

  • Proton-Pump Inhibitors Are Associated with Chronic Kidney Disease Thomas L. Schwenk, MD reviewing Lazarus B et al. JAMA Intern Med 2016 Jan 11. Schoenfeld AJ and Grady D. JAMA Intern Med 2016 Jan 11. Thomas L. Schwenk, MDA further reason to use PPIs only when their clinical benefits are clear Thomas L. Schwenk, MD Polypharmacy is one possible cause of the increasing prevalence of chronic kidney disease (CKD) in the U.S. population. Proton-pump inhibitor (PPI) use is associated with acute renal injury, but PPIs also have other biological effects, including hypomagnesemia, that can lead to excess risk for CKD. In a population-based, prospective cohort study, researchers followed 10,482 adults (mean age, 63; 80% white) with normal renal function (estimated glomerular filtration rate, >60 mL/minute/1.73 m2); at baseline, 322 participants used PPIs and 956 participants used histamine-2 (H2)–receptor antagonists. During the study (median follow-up, 14 years), PPI use increased markedly, to ≈27% of participants.At study end, the unadjusted incidence of CKD was significantly higher among baseline-PPI users than among baseline nonusers (14.2 vs. 10.7 cases per 1000 person-years); after statistical adjustment, the difference remained significant (hazard ratio, 1.5). CKD risk for baseline H2–antagonist users remained at baseline levels. A similar replication study in 249,000 participants who were followed for a median 6 years yielded similar results.Comment:These results add to increasing concerns about PPI use, including excess risks for Clostridium difficile infections, pneumonia, and fractures. Editorialists recommend monitoring renal function and magnesium levels in patients who are taking PPIs and who are at high risk for CKD; such patients should switch to H2-antagonists when possible and should not use PPIs for vague complaints of heartburn or dyspepsia. – See more at:


    The problem is that observational studies have inherent weaknesses. The following is from Wikepedia.

    Observational study

    From Wikipedia, the free encyclopedia

    Jump to: navigation, search

    In fields such as epidemiology, social sciences, psychology and statistics, an observational study draws inferences from a sample to a population where the independent variable is not under the control of the researcher because of ethical concerns or logistical constraints. One common observational study is about the possible effect of a treatment on subjects, where the assignment of subjects into a treated group versus a control group is outside the control of the investigator.[1][2] This is in contrast with experiments, such as randomized controlled trials, where each subject is randomly assigned to a treated group or a control group.



    The independent variable may be beyond the control of the investigator for a variety of reasons:

    • A randomized experiment would violate ethical standards. Suppose one wanted to investigate the abortion – breast cancer hypothesis, which postulates a causal link between induced abortion and the incidence of breast cancer. In a hypothetical controlled experiment, one would start with a large subject pool of pregnant women and divide them randomly into a treatment group (receiving induced abortions) and a control group (not receiving abortions), and then conduct regular cancer screenings for women from both groups. Needless to say, such an experiment would run counter to common ethical principles. (It would also suffer from various confounds and sources of bias, e.g.,it would be impossible to conduct it as a blind experiment.) The published studies investigating the abortion–breast cancer hypothesis generally start with a group of women who already have received abortions. Membership in this “treated” group is not controlled by the investigator: the group is formed after the “treatment” has been assigned.[citation needed]
    • The investigator may simply lack the requisite influence. Suppose a scientist wants to study the public health effects of a community-wide ban on smoking in public indoor areas. In a controlled experiment, the investigator would randomly pick a set of communities to be in the treatment group. However, it is typically up to each community and/or its legislature to enact a smoking ban. The investigator can be expected to lack the political power to cause precisely those communities in the randomly selected treatment group to pass a smoking ban. In an observational study, the investigator would typically start with a treatment group consisting of those communities where a smoking ban is already in effect.[citation needed]
    • A randomized experiment may be impractical. Suppose a researcher wants to study the suspected link between a certain medication and a very rare group of symptoms arising as a side effect. Setting aside any ethical considerations, a randomized experiment would be impractical because of the rarity of the effect. There may not be a subject pool large enough for the symptoms to be observed in at least one treated subject. An observational study would typically start with a group of symptomatic subjects and work backwards to find those who were given the medication and later developed the symptoms. Thus a subset of the treated group was determined based on the presence of symptoms, instead of by random assignment.

    Types of observational studies

    • Case-control study: study originally developed in epidemiology, in which two existing groups differing in outcome are identified and compared on the basis of some supposed causal attribute.
    • Cross-sectional study: involves data collection from a population, or a representative subset, at one specific point in time.
    • Longitudinal study: correlational research study that involves repeated observations of the same variables over long periods of time.
    • Cohort study or Panel study: a particular form of longitudinal study where a group of patients is closely monitored over a span of time.
    • Ecological study: an observational study in which at least one variable is measured at the group level.

    Degree of usefulness and reliability

    Although observational studies cannot be used as reliable sources to make statements of fact about the “safety, efficacy, or effectiveness” of a practice,[3] they can still be of use for some other things:

    “[T]hey can: 1) provide information on “real world” use and practice; 2) detect signals about the benefits and risks of…[the] use [of practices] in the general population; 3) help formulate hypotheses to be tested in subsequent experiments; 4) provide part of the community-level data needed to design more informative pragmatic clinical trials; and 5) inform clinical practice.”[3]

    Bias and compensating methods

    In all of those cases, if a randomized experiment cannot be carried out, the alternative line of investigation suffers from the problem that the decision of which subjects receive the treatment is not entirely random and thus is a potential source of bias. A major challenge in conducting observational studies is to draw inferences that are acceptably free from influences by overt biases, as well as to assess the influence of potential hidden biases.

    An observer of an uncontrolled experiment (or process) records potential factors and the data output: the goal is to determine the effects of the factors. Sometimes the recorded factors may not be directly causing the differences in the output. There may be more important factors which were not recorded but are, in fact, causal. Also, recorded or unrecorded factors may be correlated which may yield incorrect conclusions. Finally, as the number of recorded factors increases, the likelihood increases that at least one of the recorded factors will be highly correlated with the data output simply by chance.

    In lieu of experimental control, multivariate statistical techniques allow the approximation of experimental control with statistical control, which accounts for the influences of observed factors that might influence a cause-and-effect relationship. In healthcare and the social sciences, investigators may use matching to compare units that nonrandomly received the treatment and control. One common approach is to use propensity score matching in order to reduce confounding.[4]

    A report from the Cochrane Collaboration in 2014 came to the conclusion that observational studies are very similar in results reported by similarly conducted randomized controlled trials. In other words, it reported little evidence for significant effect estimate differences between observational studies and randomized controlled trials, regardless of specific observational study design, heterogeneity, or inclusion of studies of pharmacological interventions. It therefore recommended that factors other than study design per se need to be considered when exploring reasons for a lack of agreement between results of randomized controlled trials and observational studies.[5]

    In 2007, several prominent medical researchers issued the Strengthening the reporting of observational studies in epidemiology (STROBE) statement, in which they called for observational studies to conform to 22 criteria that would make their conclusions easier to understand and generalise.[6]

    Correlation does not imply causation” is a phrase used in statistics to emphasize that a correlation between two variables does not imply that one causes the other.[1][2] Many statistical tests calculate correlation between variables. A few go further, using correlation as a basis for testing a hypothesis of a true causal relationship; examples are the Granger causality test and convergent cross mapping.[clarification needed (hypothesis testing not well explained here)]

    The counter-assumption, that “correlation proves causation”, is considered a questionable cause logical fallacy in that two events occurring together are taken to have a cause-and-effect relationship. This fallacy is also known as cum hoc ergo propter hoc, Latin for “with this, therefore because of this”, and “false cause”. A similar fallacy, that an event that follows another was necessarily a consequence of the first event, is sometimes described as post hoc ergo propter hoc (Latin for “after this, therefore because of this”).

    For example, in a widely studied case, numerous epidemiological studies showed that women taking combined hormone replacement therapy (HRT) also had a lower-than-average incidence of coronary heart disease (CHD), leading doctors to propose that HRT was protective against CHD. But randomized controlled trials showed that HRT caused a small but statistically significant increase in risk of CHD. Re-analysis of the data from the epidemiological studies showed that women undertaking HRT were more likely to be from higher socio-economic groups (ABC1), with better-than-average diet and exercise regimens. The use of HRT and decreased incidence of coronary heart disease were coincident effects of a common cause (i.e. the benefits associated with a higher socioeconomic status), rather than a direct cause and effect, as had been supposed.[3]

    As with any logical fallacy, identifying that the reasoning behind an argument is flawed does not imply that the resulting conclusion is false. In the instance above, if the trials had found that hormone replacement therapy does in fact have a negative incidence on the likelihood of coronary heart disease the assumption of causality would have been correct, although the logic behind the assumption would still have been flawed.

    BOTTOM LINE: I don’t know if proton pump inhibitors cause kidney disease just like I don’t know if calcium supplements cause heart disease or statins cause ALS. All of these have been implicated in previous observational studies.  I do know that all medication should be used cautiously and not indiscriminately. It is worthwhile to periodically review the drugs that your are taking and discuss with your physician if they should be continued.



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“Medical Taylorism” or What is Wrong With Medicine Today

Monday, January 18, 2016 // Uncategorized

This is an excellent editorial from the most recent issue of the New England Journal of Medicine that resonated with me. I wanted to share it. It wasn’t surprising who authored it, two of my favorite authors.

Medical Taylorism

Pamela Hartzband, M.D., and Jerome Groopman, M.D.

N Engl J Med 2016; 374:106-108January 14, 2016DOI: 10.1056/NEJMp1512402

Frederick Taylor, a son of Philadelphia aristocrats who lived at the turn of the last century, became known as the “father of scientific management” — the original “efficiency expert.” He believed that the components of every job could and should be scientifically studied, measured, timed, and standardized to maximize efficiency and profit. Central to Taylor’s system is the notion that there is one best way to do every task and that it is the manager’s responsibility to ensure that no worker deviates from it. “In the past, the man has been first; in the future, the system must be first,” Taylor asserted.1

Toyota, inspired by these principles of “Taylorism,” successfully applied them to the manufacture of cars, thereby improving quality, eliminating waste, and cutting costs. As health care comes under increasing economic pressure to achieve these same goals, Taylorism has begun permeating the culture of medicine.

Advocates lecture clinicians about Toyota’s “Lean” practices, arguing that patient care should follow standardized systems like those deployed in manufacturing automobiles. Colleagues have told us, for example, that managers with stopwatches have been placed in their clinics and emergency departments to measure the duration of patient visits. Their aim is to determine the optimal time for patient–doctor interactions so that they can be standardized.

Meanwhile, the electronic health record (EHR) — introduced with the laudable goals of making patient information readily available and improving safety by identifying dangerous drug–drug interactions — has become a key instrument for measuring the duration and standardizing the content of patient–doctor interactions in pursuit of “the one best way.” Encounters have been restructured around the demands of the EHR: specific questions must be asked, and answer boxes filled in, to demonstrate to payers the “value” of care. Open-ended interviews, vital for obtaining accurate clinical information and understanding patients’ mindsets, have become almost impossible, given the limited time allotted for visits — often only 15 to 20 minutes. Instead, patients are frequently given checklists in an effort to streamline the interaction and save precious minutes. The EHR was supposed to save time, but surveys of nurses and doctors show that it has increased the clinical workload and, more important, taken time and attention away from patients.

Physicians sense that the clock is always ticking, and patients are feeling the effect. One of our patients recently told us that when she came in for a yearly “wellness visit,” she had jotted down a few questions so she wouldn’t forget to ask them. She was upset and frustrated when she didn’t get the chance: her physician told her there was no time for her questions because a standardized list had to be addressed — she’d need to schedule a separate visit to discuss her concerns.

We believe that the standardization integral to Taylorism and the Toyota manufacturing process cannot be applied to many vital aspects of medicine. If patients were cars, we would all be used cars of different years and models, with different and often multiple problems, many of which had previously been repaired by various mechanics. Moreover, those cars would all communicate in different languages and express individual preferences regarding when, how, and even whether they wanted to be fixed. The inescapable truth of medicine is that patients are genetically, physiologically, psychologically, and culturally diverse. It’s no wonder that experts disagree about the best ways to diagnose and treat many medical conditions, including hypertension, hyperlipidemia, and cancer, among others.

To be sure, certain aspects of medicine have benefited from Taylor’s principles. Strict adherence to standardized protocols has reduced hospital-acquired infections, and timely care of patients with stroke or myocardial infarction has saved lives. It may be possible to find one best way in such areas. But this aim cannot be generalized to all of medicine, least of all to such cognitive tasks as eliciting an accurate history, synthesizing clinical and laboratory data to make a diagnosis, and weighing the risks and benefits of a given treatment for an individual patient. Good thinking takes time, and the time pressure of Taylorism creates a fertile field for the sorts of cognitive errors that result in medical mistakes. Moreover, rushed clinicians are likely to take actions that ignore patients’ preferences.

Part of the original promise of scientific management was that increased efficiency and standardization would not only result in a better product at lower cost, but would also give workers more free time to enjoy life. Lillian Gilbreth, who with her husband Frank championed motion studies of workers to boost their efficiency, called this outcome saving time for “happiness minutes”2 (see Perspective article by Gainty, pages xxx–xx). Similarly, some prominent policymakers have claimed that implementing scientific management in medicine would free doctors, nurses, and other members of the clinical team to spend more time with their patients.3 In fact, the opposite seems to be happening. Yet some of the greatest rewards of working in medicine come from spending unstructured time with our patients, sharing their joys and sorrows.

Instead of gaining happiness minutes, clinicians are increasingly experiencing dissatisfaction and burnout as they’re subjected to the time pressures of Taylorism and scientific management in the name of efficiency. We have watched colleagues fleeing to concierge practices, where they have control over their schedules. Others have taken early retirement, unwilling to compromise on what they believe is the time needed to deliver compassionate care. Some have moved into management or consulting positions, where they tell others how to practice while unburdening themselves of their clinical load. Just as Taylor enriched himself by consulting for companies, a growing and lucrative industry has emerged to generate and enforce metrics in medicine. By 2014, the Centers for Medicare and Medicaid Services alone had mandated the use of more than 1000 performance measures. As the Institute of Medicine recently reported, such metrics have proliferated, though many of them have little proven value.4

There is a certain hypocrisy among some of the most impassioned advocates for efficiency and standardization in health care, as Boston neurologist Martin Samuels recently pointed out. “They come from many different backgrounds: conservatives, liberals, academics, business people, doctors, politicians, and more often all the time various combinations of these. But they all have one characteristic in common. They all want a different kind of health care for themselves and their families than they profess for everyone else.”5 What they want is what every patient wants: unpressured time from their doctor or nurse and individualized care rather than generic protocols for testing and treatment.

Yet students are now taught the principles of Taylorism and Toyota Lean as early as their first year of medical school. They enter clinical rotations believing that there must be one best way to diagnose and treat every medical condition. In residency training and beyond, they discover that’s not the case, and they face a steep learning curve as they take on primary responsibility for patient care. We learn how to modify and individualize care in the real world, recognizing the variety of clinical presentations, the reality of multiple coexisting conditions, the variability of human biology, the effects of social and cultural contexts, and the diversity of patients’ preferences regarding risk and benefit, all of which defy rigid protocols.

Medical Taylorism began with good intentions — to improve patient safety and care. But we think it has gone too far. To continue to train excellent physicians and give patients the care they want and deserve, we must reject its blanket application. That we’re beginning to do so is shown, for example, by a bill before Congress that would delay implementation of the Meaningful Use Stage 3 criteria for information-technology use in health care. We need to recognize where efficiency and standardization efforts are appropriate and where they are not. Good medical care takes time, and there is no one best way to treat many disorders. When it comes to medicine, Taylor was wrong: “man” must be first, not the system.

Disclosure forms provided by the authors are available with the full text of this article at

From Beth Israel Deaconess Medical Center and Harvard Medical School — both in Boston.



Taylor FW. The principles of scientific management. New York: Harper & Brothers, 1911.



Lepore J. Not so fast: scientific management started as a way to work. How did it become a way of life? New Yorker October 12, 2009:12-12



Swensen SJ, Meyer GS, Nelson EC, et al. Cottage industry to postindustrial care — the revolution in health care delivery. N Engl J Med 2010;362:e12-e12
Free Full Text | Web of Science | Medline


Blumenthal D, McGinnis JM. Measuring vital signs: an IOM report on core metrics for health and health care progress. JAMA 2015;313:1901-1902
CrossRef | Web of Science | Medline


Samuels M. The anti-hypocrisy rule. Forbes 2014 (

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Bad News Causes Deaths?

Wednesday, December 9, 2015 // Uncategorized

We are all inundated by medical news. It is all around us. Most people who hear it give it equal weight, but there is a wide variation in the quality and accuracy of it. This study shows the negative effect that medical news can have. People with heart disease stop their statins, medication which can prolong life and reduce the risk of heart attacks and stroke because of this negative news and some die as a result of this.

Negative news about statins is causing early death for heart disease patients
University of Copenhagen Faculty of Health and Medical Sciences News, 12/08/2015

Researchers in Denmark have found that negative news stories about statins are linked to some people choosing to discontinue their statin treatment, which, in consequence, is associated with an increased risk of heart attacks and dying from heart disease. The study, which was published in the European Heart Journal, shows that for every negative nationwide news story about the cholesterol–lowering group of medicines, there was a nine percent increased risk of people deciding to stop taking statins within six months of first being prescribed the drug. “We found that exposure to negative news stories about statins was linked to stopping statins early and explained two percent of all heart attacks and one percent of all deaths from cardiovascular disease associated with early discontinuation of statins,” said Professor Borge Nordestgaard, Chief Physician at Copenhagen University Hospital in Denmark. During the period from 1995 to 2010 the proportion of people on statins increased from less than one percent to 11%, while early statin discontinuation increased from six percent to 18%. The number of all statin–related news stories (positive, neutral and negative) increased from 30 per year in 1995 to 400 in 2009. In addition to the increased risk from negative news stories, the researchers found that the risk of early statin discontinuation increased per increasing calendar year (4%), increased daily dose (4%), being male (5%), living in cities (13%) and for being of non–Danish ethnicity (67%). In contrast, the risk of discontinuation decreased after exposure to positive news stories about statins (8%), and having cardiovascular disease or diabetes at the time the statins were first prescribed (27% and 9% respectively). In this study the researchers find that close to one in six of individuals discontinue therapy at an early stage, and this represents a major problem for cardiovascular health. These findings suggest a need to develop ways of increasing people’s adherence to statin therapy during the first six months in particular. “Positive news stories tend to be evidence–based, explaining how statins can prevent heart disease and early death, while this is often not the case for negative news stories, which tend to focus on relatively rare and moderate side effects. Considering how often there is a negative statin–related news story, we detected a surprisingly strong association: an increase of nine percent in early discontinuation for each nationwide story. If negative statin–related news stories did not exist at all, then early statin discontinuation would decrease by 1.3% in the whole of the population,” prof Nordestgaard concluded.

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