Category Archives: General Health

“Not Up For Debate: The Science Behind Vaccination”

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Wednesday’s well publicized debate unfortunately discussed vaccination.  Perhaps it is not surprising that a businessman/entertainer, Donald Trump, reiterated misinformation.  Yet, the two former physicians (Ben Carson and Rand Paul) on the stage also provided misleading information.  A good write-up of this issue from the NY Times: Not Up for Debate: The Science Behind Vaccination

Here’s an excerpt:

Here are the facts:

  • Vaccines aren’t linked to autism.
  • The number of vaccines children receive is not more concerning than it used to be.
  • Delaying their administration provides no benefit, while leaving children at risk.
  • All the childhood vaccines are important.

ICD-10: Source for humor?

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Like most physicians, I am not terribly excited about the transition to ICD-10.  The increased detail with coding will take longer and be a hassle. However, there is apparently some humor to be derived from the institution of ICD-10.

From HealthcareDive.com: “There are 68,000 billing codes under the new ICD-10 system, as opposed to a paltry 13,000 under the current ICD-9. …Despite the controversy surrounding ICD-10, there is one universally agreed-upon upside to the hyper-specific coding system: Weird and obscure codes that stand for bizarre medical injuries. There’s even an illustrated book, Struck by an Orca: ICD-10 Illustrated.”

Some of the absurd ICD-10 codes from HealthcareDive.com:

  • V97.33XD: Sucked into jet engine, subsequent encounter
  • Y92.146: Swimming-pool of prison as the place of occurrence of the external cause
  • W55.41XA: Bitten by pig, initial encounter​
  • W61.62XD: Struck by duck, subsequent encounter
  • Z63.1: Problems in relationship with in-laws
  • W220.2XD: Walked into lamppost, subsequent encounter
  • Y93.D: V91.07XD: Burn due to water-skis on fire, subsequent encounter​
  • W55.29XA: Other contact with cow, subsequent encounter
  • W22.02XD: V95.43XS: Spacecraft collision injuring occupant, sequela
  • W61.12XA: Struck by macaw, initial encounter
  • R46.1: Bizarre personal appearance

Multiple authorities have weighed in on the issue of which ICD-10 codes are most zany. Here are a few links:

University of South Florida their list includes

  • Knitting and Crocheting (Y93.D1)
  • Pecked by chicken, initial encounter (W61.33XA)

Multibriefs Exclusive their list includes

  • T71.231D Asphyxiation due to being trapped in a discarded refrigerator, accidental
  • V80.730A Animal-rider injured in collision with trolley
  • Z62.1 Parental overprotection
  • T63 Unspecified event, undetermined intent

NY Times: Roughed up by an Orca? There’s a code for that (from 12/29/13) “There are codes for injuries incurred in opera houses and while knitting, and one for sibling rivalry.” This article has some nice graphics, including one of a water skier with the skis on fire.

Does Staying Up All Night Affect Surgery the Next Day?

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According to a recent study (A Govindarajan et al. NEJM 2015; 373: 845-33), the answer is no.  That being said, my preference would be for a well-rested surgeon.

Some of the details:

The authors conducted a retrospective, population-based, matched cohort study in Ontario, Canada.  Twelve procedures were analyzed from 1448 physicians and involving 38,978 patients.  The same physicians had his/her procedures compared when they were done after treating patients from midnight to 7am to when these were done on days that were not preceded by night call.  The physicians included in the study were attending physicians; thus this does not provide insight into whether residents or fellows would perform similarly.

Key finding:

  • No difference in any primary outcome: death, readmission, or complication.  This primary outcome occurred in 22.2% after night call and 22.4% without night call.

Here’s a graph below -which depicts, from top to bottom, odds ratio for cholecystectomy (n=9322 patients, 479 physicians), gastric bypass (n=320 patients, 25 physicians), colon resection (n=2214 patients, 315 physicians), hysterectomy (n=7020 patients, 384 physicians), knee arthroplasty (n-2504 patients, 192 physicians), hip arthroplasty (n=1564 patients, 154 physicians), repair hip fracture (n=1192 patients, 166 physicians), lung resection (n=550 patients, 55 physicians), CABG (n=460 patients, 48 physicians), Spine surgery (n=3456 patients, 104 physicians), Craniotomy (n=1396patients, 66 physicians), Angioplasty (n=8980 patients, 130 physicians)

From NEJM Twitter Feed

From NEJM Twitter Feed

FDA Approves New Drug for Nausea/Vomiting

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FDA Announcement -here’s excerpt:

The U.S. Food and Drug Administration approved Varubi (rolapitant) to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Varubi is approved in adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing (emetogenic and highly emetogenic) cancer chemotherapy….

“Chemotherapy-induced nausea and vomiting remains a major issue that can disrupt patients’ lives and sometimes their therapy,” said Amy Egan, M.D., M.P.H., deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “Today’s approval provides cancer patients with another treatment option for the prevention of the delayed phase of nausea and vomiting caused by chemotherapy.”

Varubi is a substance P/neurokinin-1 (NK-1) receptor antagonist. Activation of NK-1 receptors plays a central role in nausea and vomiting induced by certain cancer chemotherapies, particularly in the delayed phase. Varubi is provided to patients in tablet form.

The safety and efficacy of Varubi were established in three randomized, double-blind, controlled clinical trials where Varubi in combination with granisetron and dexamethasone was compared with a control therapy (placebo, granisetron and dexamethasone) in 2,800 patients receiving a chemotherapy regimen that included highly emetogenic (such as cisplatin and the combination of anthracycline and cyclophosphamide) and moderately emetogenic chemotherapy drugs. Those patients treated with Varubi had a greater reduction in vomiting and use of rescue medication for nausea and vomiting during the delayed phase compared to those receiving the control therapy…

The most common side effects in patients treated with Varubi include a low white blood cell count (neutropenia), hiccups, decreased appetite and dizziness.

Varubi is marketed by Tesaro Inc., based in Waltham, Massachusetts.

Upside Down Incentives in Pharmaceutical Development –Profit over Patients

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A good read on why cheap effective drugs may not be coming to the market in the U.S. –as well as solutions. (Full text: AR Kellermann, NR Desai. JAMA. Published online August 17, 2015. doi:10.1001/jama.2015.10114)

Here’s an excerpt:

In 2003, Wald and Law proposed to combine 3 half-dose antihypertensive agents, an intermediate-dose statin, low-dose aspirin, and folic acid into a once per day polypill for primary and secondary prevention of cardiovascular disease. Based on epidemiological models, they estimated that daily use by individuals aged 55 years or older could reduce the incidence of MI and stroke by more than 80%.

In the 12 years since this report was published,3 versions of the polypill have been successfully tested in several phase 2 (safety) studies and a few modest-sized phase 3 (efficacy) trials. Collectively, these studies demonstrated that the polypill was well tolerated, achieved good adherence, and based on intermediate end points, such as reduction of blood pressure and low-density lipoprotein cholesterol level, is efficacious…

The 4 drugs in the current version of the polypill have long histories of safe use. Although all 4 are frequently prescribed in the United States, the US Food and Drug Administration (FDA) has not approved combining them in a single pill…

Although the polypill could produce substantial public health benefits, people in the United States are unlikely to find out anytime soon. This is because the pill’s price is so low (≤$1 per tablet) and the cost of the large clinical trials required for FDA approval is so high, it is unattractive to investors. The inventor’s dilemma is that creating a product that improves health is not enough; the product must also be able to generate a healthy return on investment. In the United States, the surest way to generate a healthy return on investment is to increase health care spending, not reduce it.

Related blog posts:

“Negative Externality,” Splitting Checks, and Feeding Psychology

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If you have a great psychology book that you recommend, please let me know.  As frequent readers of this blog know, I am fascinated with psychology experiments.

In a recent blog from fivethirtyeight.com, the author tackles the question of whether people eat more when they know they are splitting a dinner check. Does it Make Sense to Split The Check at a Restaurant?

Here’s an excerpt:

In 2004, a study in The Economic Journal, a publication of the Royal Economic Society, …the researchers told four groups of diners (always three men and three women) to split the bill equally among them. They told another four groups to pay for what they had ordered. Lastly, they told two lucky groups that they would get their meals for free…

Those who were getting a free meal spent the most … Those who were splitting the bill spent less, and those who were paying individually spent the least…

Any time you make a decision that affects someone else without considering how it might affect that person, whether positively or negatively, you create an externality — it’s basically a fancy way of saying “indirect effect.” There are positive externalities (e.g. when you decide to get a flu shot, other people benefit) and negative externalities (e.g. when you decide to fart, other people suffer).

The unscrupulous diner’s dilemma reveals how negative externalities — and even the mere threat of negative externalities — affect our behavior. Participants in the bill-splitting experiment expected the others to order more, so they tried to maximize what they could get out of the situation by ordering more themselves.

Bottomline: It is fascinating to me how something as simple as splitting a bill may encourage someone to order a lot more.

Related blog posts:

Near Fairy Falls, YW

How the Trans-Pacific Partnership Could Affect Health Outcomes

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Generally, trade agreements are not something I scrutinize and typically have little to do with the medical field.  Recently, I was surprised to learn that the Trans-Pacific Partnership (TPP) has language in its intellectual property chapter that could impact the lives of millions (A Kapczynski. NEJM 2015; 373: 201-3).  The background for this story is that pharmaceutical companies want to have patent protection for their medications for as long as possible.  This has a substantial impact on pricing.  “For example, patents increase the annual cost of antiretroviral therapy from around $100 per person to $10,000 per person.”

Some countries, like India, have undermined patent protections.  “India allows patents on new drugs but not on new uses of old drugs or new forms of known drugs that do not increase therapeutic efficacy.”  Other countries have been following India’s lead.  Even in the U.S., there are efforts to decrease data exclusivity, which prevents regulatory agencies like the FDA from registering a generic version of a drug.

“President Barack Obama’s fiscal year 2016 budget proposes rolling back the data exclusivity period for biologic drugs in the United States to 7 years from 12 years, yielding a projected savings of more than $4 billion over the next decade. In the TPP negotiations, however, the United States is proposing a 12-year term of exclusivity.”

Other potential concerns include both the elimination of a provision to use “competitive market-derived prices” and the potential for promoting foreign companies to sue TPP countries for millions of dollars in damages due to loss of profits.

Currently there are escalating drug prices, both with innovative new medications and well-established treatments. Even lifesaving cures are being rationed in the United States.  While the TPP has not been finalized, there are provisions that could limit the United States  from regulating “critical aspects of health policy for years to come.”

Related blog posts:

Cascade Canyon, Grand Tetons

Cascade Canyon, Grand Tetons

 

 

Understanding the Problem Physicians Have With Retail Clinics

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Two articles highlight the upside and downside of retail clinics.

  • Iglehart JK. NEJM 2015; 301-3
  • Chang JE et al. NEJM 2015; 382-8

Currently, there are ~1900 retail clinics with four main ‘players:’ CVS, Walgreens, Kroger, and Target.  However, Target has recently made a deal with CVS and Walmart is expanding into retail clinics as well.  Almost all of these clinics accept private insurance and medicare; growing numbers accept medicaid too.

Retail clinics offer a limited scope of care and typically are staffed by midlevel providers (nurse practitioners or physician assistants).  In contrast, urgent cares offer more complex services and typically are staffed by physicians.

Upside:

  • For consumers, the key advantages of retail clinics: lower costs with transparent pricing, convenience due to extended hours and locations, and often short wait times.

Downside:

  • Potential disruption in longitudinal care (“medical home”)

What about quality?

  • “Research has not found that retail clinics deliver poor quality care, overprescribe antibiotics, or adversely impact delivery of preventive care.”

Do Retail Clinics Enhance Access?

  • Yes but these clinics are disproportionately located in areas with relatively high income.  Nevertheless, “approximately 61% of retail-clinic visits and 37% of urgent care visits involve patients without a primary care provider.”

Patient navigation:

  • “One study …showed that patients did properly self-triage, with more than 88% of retail-clinic episodes resolved in one visit. Another study showed that 2.3% of retail-clinic patients were triaged to an emergency department or physician’s office.”

Why Would Physicians Oppose These Retail Clinics?

  • While primary care organizations have raised concerns about quality and continuity of care, a basic economic issue is likely at work as well.  “The current reimbursement system renders simple acute health problems high-margin work that can offset losses from treating more complex problems.“

Bottomline: Retail clinics are filling a need for many patients in terms of cost and convenience for simple acute problems.

Related blog post: AAP -Behind the Scenes (Part 1)

Leek's Marina, Grand Tetons

Leek’s Marina, Grand Tetons

Would Medical Marijuana Meet the Threshold for FDA Approval?

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For most conditions –the answer is no.  A recent study was reviewed by several media outlets including the LA Times.  Here is an excerpt:

A comprehensive review of dozens of clinical trials that have tested medical marijuana for 10 conditions finds that there’s very little reliable evidence to support the drug’s use. The review, by an international team of researchers, was published Tuesday in the Journal of the American Medical Assn.

Patients who use medical marijuana to treat chronic neuropathic pain or cancer pain would probably have the least to fear from an FDA review. The JAMA study considered 28 studies involving 2,454 patients and concluded that there was “moderate-quality evidence” from at least a dozen studies showing that cannabinoids – chemicals in marijuana that produce pharmacologic effects inside the body – reduced pain in such patients by modest amounts….

The other condition for which medical marijuana proved useful was muscle spasticity in people with multiple sclerosis. After assessing 14 studies with 2,280 patients, the JAMA authors determined there was “moderate-quality evidence” to support its use in these patients, although many of the studies reported improvements that weren’t quite big enough to qualify as statistically significant…

One of the things the studies showed most clearly is that people who use medical marijuana had a “much greater risk” of side effects, including serious problems like kidney, liver and psychiatric disorders. The most common adverse effects included dizziness, confusion and disorientation,  according to the JAMA report…

The authors, from the Yale University School of Medicine, lamented the fact that state approval of medical marijuana had been based on “low-quality scientific evidence, anecdotal reports, individual testimonials, legislative initiatives, and public opinion.”

Related blog posts:

Zoo Atlanta

Zoo Atlanta

Genetically Modified Humans: Genome Editing 101

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In a review at last year’s NASPGHAN meeting, John Barnard gave a basic science review (Basic Science Year in Review -#NASPGHAN 2014 | gutsandgrowth) that touched on CRISPR-Cas9 for genome engineering (Cell 2014; 157: 1262-78).  Reading through a recent editorial (Lander ES. NEJM 2015; 373: 5-7), it seems that the potential for genome editing is not that far from landing into clinical use.

His points:

Genome editing holds great therapeutic promise…

  • “physicians might edit a patient’s immune cells to delete the CCR5 gene, conferring the resistance to HIV carried by the 1% of the U.S. population.”
  • “Editing blood stem cells might cure sickle cell anemia and hemophilia.”
  • Eliminate genes which increase the risk for Alzheimer’s, Huntingdon’s disease and heart attacks

Concerns:

  • “Genetically modified humans” and true “designer babies”
  • Technical issues to perform editing with precision.
  • Unanticipated effects with various edits. “We remain terrible at predicting the consequences of even simple genetic modification.”
  • Who decides?  Future generations cannot consent to their modification.
  • Is it morally right? “Would the ‘best’ genomes go to the most privileged?”

In the U.S., genome editing would not garner approval from FDA or NIH in the near future. But, given the advancing technical capabilities, it is not too early to begin the discussion about genome editing.  At the very least, this technology should spurn a couple great sci-fi movies.

Take-home point: “Authorizing scientists to make permanent changes to the DNA of our species is a decision that should require broad societal understanding and consent…We should exercise great caution before we rewrite” the human genome.

Zoo Atlanta (Kinda looks like a genetically-modified giraffe)

Zoo Atlanta (Kinda looks like a genetically-modified giraffe)