New USPSTF guidelines suggest reducing the volume of Vitamin D deficiency testing in the general population, which could reduce revenue for clinical laboratories
From 2005 to 2011, the volume of clinical laboratory tests for Vitamin D soared nationally as more doctors tested more patients for Vitamin D deficiency. This became a major source of revenue growth for many clinical laboratories performing those tests. But at least a portion of lab revenue associated with Vitamin D testing may be in jeopardy.
In a recommendation statement published in JAMA Network, titled, “Screening for Vitamin D Deficiency in Adults,” the United States Preventive Services Task Force (USPSTF)—following up on its 2014 recommendations—stated “that the current evidence is insufficient to assess the balance of benefits and harms of screening for Vitamin D deficiency in asymptomatic adults.”
The USPSTF’s new recommendations concerning Vitamin D testing came after the federal task force performed an extensive review of the benefits and potential harm of screening for Vitamin D deficiencies in non-pregnant adults who displayed no symptoms of a deficiency. Symptoms of a Vitamin D deficiency include fatigue and tiredness, bone and back pain, depression, impaired would healing, bone loss, hair loss, and muscle pain.
After completing its research, the USPSTF concluded “the overall evidence on the benefits of screening for Vitamin D deficiency is lacking. Therefore, the balance of benefits and harms of screening for Vitamin D deficiency in asymptomatic adults cannot be determined.”
Are USPSTF Conclusions Contrary to Current Deficiency Testing Practices?
“Among asymptomatic, community-dwelling populations with low Vitamin D levels, the evidence suggests that treatment with Vitamin D has no effect on mortality or the incidence of fractures, falls, depression, diabetes, cardiovascular disease, cancer, or adverse events,” the JAMA Network article states.
Other studies have linked low Vitamin D levels with some health conditions and risks, however, the USPSTF review found no studies that directly evaluated any perks associated with Vitamin D screening in otherwise healthy individuals.
Everyday Health listed 10 illnesses linked to low Vitamin D deficiency. They include:
“We see a lot of associations between Vitamin D deficiency and poor health outcomes,” Mary Byrn, PhD, RN, an associate professor at Loyola University in Chicago who studies Vitamin D, told Everyday Health. “Although these are relationships and we are unable to conclude cause and effect, taking Vitamin D supplements or exposing yourself to the sun in a safe manner to increase Vitamin D naturally are easy ways to improve your health and try to reduce your risk of multiple diseases,” she said. (Photo copyright: Midwest Nursing Research Society.)
Can Vitamin D Supplementation Be Harmful?
The USPSTF study also stated that Vitamin D supplementation appears to be safe and that toxicity from too much Vitamin D would be rare. One of the USPSTF’s key concerns of screening for Vitamin D in asymptomatic individuals was the potential for misclassification and inaccurate diagnoses.
The study also revealed that more research is needed to determine what serum levels are optimal when diagnosing a Vitamin D deficiency, and whether those levels vary by subgroups, such as race, ethnicity, or gender.
The JAMA Network article states that “the evidence is inconclusive about the effect of treatment on physical functioning and infection.”
The amount of Vitamin D individuals need each day depends upon their age. The National Institutes of Health (NIH) recommends that adults between the ages of 19 and 70 get 15 micrograms or 600 International Units (IU) of Vitamin D daily.
According to an NIH fact sheet, people can receive Vitamin D through sun exposure, supplements, and some food, such as fatty fish, mushrooms, beef liver, cheese, and egg yolks, plus foods that are fortified with Vitamin D, such as some milk products and breakfast cereals.
Vitamin D and COVID-19
It has been widely reported that approximately 42% of Americans are Vitamin D deficient. And Vitamin D deficiency has been linked to an increased risk of contracting the SARS-CoV-2 coronavirus and how well patients recover after COVID-19 treatment.
A study published in the Journal of Clinical Endocrinology and Metabolism that examined 216 COVID-19 hospitalized patients in Spain found that over 80% of those individuals were deficient in Vitamin D. The study also found that COVID-19 patients who had lower Vitamin D levels also had a higher number of inflammatory markers that have been associated with poorer COVID-19 outcomes. The results of this study were in March.
For several decades, experts have recommended avoiding sun exposure and using sunscreen to avoid skin cancers. This may have caused people to get less Vitamin D from sun exposure. It may also have contributed to an increase in the number of Vitamin D deficiencies and increased COVID-19 infections.
Pathologists and clinical laboratory managers should keep in mind that the USPSTF recommended less testing for Vitamin D deficiencies in asymptomatic individuals. This proposal may affect test volume in clinical laboratories, as Vitamin D testing has been a common and lucrative assay for many years.
Clinical laboratory managers may want to follow the debate that surfaced shortly after publication of the study in a peer-reviewed journal, when editors of the journal issued concerns over the researchers’ claims
Virologists and medical laboratory scientists continue to investigate ways the SARS-CoV-2 coronavirus can be defeated using the body’s own defenses in conjunction with medical treatments and a possible vaccine. Now, researchers at the Boston University School of Medicine have discovered that higher levels of vitamin D in the blood may improve chances of recovering from a COVID-19 infection.
“This study provides direct evidence that Vitamin D sufficiency can reduce the complications, including the cytokine storm (release of too many proteins into the blood too quickly) and ultimately death from COVID-19,” Michael F. Holick, PhD, MD, Professor of Medicine, Physiology and Biophysics at Boston University School of Medicine and one of the authors of the study, told SciTechDaily.
Holick is well-known in the scientific community for his many published studies on Vitamin D. In 2018, Kaiser Health News and The New York Times published a retrospective on Holick and his advocacy on behalf of Vitamin D, titled, “The Man Who Sold America On Vitamin D—and Profited in the Process.” In that story, Holick acknowledged working as a consultant for several organizations, including Quest Diagnostics in a relationship that dates back to 1979. KHN and NYT noted that Quest Diagnostics performs Vitamin D tests.
The Boston University researchers published their study in PLOS ONE, a peer-reviewed open-access scientific journal published by the Public Library of Science (PLOS). The paper’s apparent conclusions, however, invoked an “expression of concern” from the journal’s editors, which, along with direct responses from the Boston University researchers, can be read on PLOS ONE.
Can Vitamin D Save Lives?
To perform their research, the Boston University researchers examined the Vitamin D levels of 235 patients who had been admitted to a hospital with a SARS-CoV-2 infection. The patients were then tracked for clinical outcomes, including:
Blood samples were also analyzed for the number of lymphocytes and inflammatory markers. The researchers compared the collected data between patients who were sufficient to those who were deficient in Vitamin D levels.
They determined that patients over the age of 40 who were Vitamin D sufficient were 51.5% less likely to die from a COVID-19 infection than those who were deficient in the vitamin.
“Because Vitamin D deficiency and insufficiency is so widespread in children and adults in the United States and worldwide, especially in the winter months, it is prudent for everyone to take a vitamin D supplement to reduce risk of being infected and having complications from COVID-19,” Michael F. Holick, PhD, MD (above), told SciTechDaily. The Boston University School of Medicine professor and study author has been praising the health benefits of Vitamin D for years. He played a role in drafting national guidelines for the vitamin and also authored books that tout the advantages of Vitamin D, the importance of UV rays, and the biologic effects of light. (Photo copyright: Boston Herald.)
How Vitamin D Works and Why It’s So Important
In a fact sheet, the National Institutes of Health (NIH) recommend that adults between the ages of 19 and 70 take 15 micrograms (mcg) or 600 International Units (IU) of Vitamin D per day. Adults over the age of 70 should increase that amount to 20 mcg or 800 IUs per day.
According NBC News, Americans spent $936 million on supplements in 2017, which was nine times more than the previous decade. That article also stated that medical laboratory testing for Vitamin D levels have exponentially increased over the years. More than 10 million tests for Vitamin D levels were ordered for Medicare patients in 2016 at a cost of $365 million, which represents an increase of 547% since 2007. Currently, approximately one in four adults over the age of 60 in the US take Vitamin D supplements.
The NIH fact sheet notes that Vitamin D is a nutrient found in cells throughout the body and is needed for good health and to maintain strong bones. Individuals who are deficient in Vitamin D may develop soft, thin, brittle bones, as well as rickets in children and osteomalacia in adults. Vitamin D also helps the immune system fight off invading bacteria and viruses, helps nerves carry messages between the brain and other body parts, and helps muscles move. It can also play a role in warding off osteoporosis in older adults.
Very few foods naturally contain Vitamin D. The best dietary sources for the vitamin are fatty fish such as salmon, tuna, and mackerel, and foods fortified with Vitamin D, such as milks, some breakfast cereals, and yogurt. Being outside on sunny days is another way to obtain Vitamin D, as the body makes the vitamin when skin is directly exposed to the sun.
The Boston University study outlines the advantages of having sufficient Vitamin D levels, as well as how the vitamin may help ward off and possibly lessen the effects of infections like COVID-19, though those conclusions have been called into question.
Nevertheless, individuals who are deficient in the vitamin may want to take a supplement or get plenty of sunshine, just to be on the safe side. And clinical laboratory managers will want to keep in mind that over the years “the steady increase in physician and patient demand for Vitamin D tests has kept most clinical and pathology laboratories scrambling to maintain turnaround times and quality,” which Dark Daily reported in “Why Vitamin D Continues to Be the World’s Fastest-Growing Clinical Laboratory Test.”
CEO Summary:Editor-In-Chief Robert L. Michel gave blood for the cause and it’s another laboratory industry first! To understand what doctors and patients see as national labs use different methodologies and reference ranges to report Vitamin 25(OH) D results, his blood was tested 24 times by nine laboratories. The results were unveiled at the Executive War College last May in New Orleans. These results are published here, along with comments from the All-Star Vitamin D Panel experts who discussed reasons why doctors might be confused and might misinterpret Vitamin D lab test results.
UNTIL RECENT YEARS, THE VITAMIN D TESTING MARKET was a rather quiet, uncontroversial corner of the lab testing marketplace. This was true because of the widespread acceptance and use of a long-established, FDA-cleared immunoassay test for Vitamin 25(OH) D.
However, this status quo in Vitamin D was disrupted when some national laboratories began performing Vitamin 25(OH) D testing using tandem mass spectrometry (LC-MS). For a variety of reasons, this different methodology introduced a new element of complexity for physicians and their patients.
In recent years, laboratory scientists and pathologists have begun to publicly discuss and debate the pros and cons of testing for Vitamin 25(OH) D by each of the available methodologies.Much of this discussion centers on analytical precision.
However, this scientific debate about analytical precision of different methodologies among laboratory testing professionals often fails to recognize the needs of physicians and their patients. Clinical laboratory testing is done at the specific request of a physician who is evaluating and treating a patient. These physicians and patients are the true customers of the clinical laboratory, Thus, their needs and expectations for Vitamin 25(OH) D testing should be addressed in the public discussions of laboratory scientists.
During the All-Star Vitamin D Panel at the Executive War College in New Orleans last May, the perspective of the patient was introduced in a novel and unique way. Robert L. Michel, moderator of the panel and Editor-In-Chief of THE DARK REPORT, shared the results of 24 Vitamin D tests performed on his blood by nine different laboratories in the United States.
February 24 Audio Conference will cover the A-to-Z of Vitamin 25(OH) D Testing
Clinical laboratory testing for Vitamin 25(OH) D continues to the fastest-growing test on the medical laboratory menu, in the United States and other developed nations around the globe. Over the past four years, the steady increase in physician and patient demand for Vitamin D tests has kept most pathology laboratories scrambling to maintain turnaround times and quality.
To help laboratories understand and respond to this unprecedented demand for a simple laboratory test, national Vitamin D expert Bruce Hollis, Ph.D., Director of Pediatric Nutritional Sciences at the Medical University of South Carolina will conduct a special audio conference on February 24 at 1:00 P.M. EST. Pathologists and laboratory professionals will find Dr. Hollis’ session to be an essential and comprehensive explanation of why Vitamin D has become a high profile subject in medicine and how they should position their clinical laboratories to best serve the demand for Vitamin D knowledge and testing.
Get information on the latest developments in Vitamin D testing when you join THE DARK REPORT and DARK DAILY for this exceptional audio conference on CD, “The A-to-Z of Vitamin D: Why It’s Today’s Hottest Lab Test!”
Demand for Vitamin 25(OH) D testing is going through the roof! In recent years, it has been, hands-down, the fastest-growing test by volume. Your lab has an unprecedented opportunity to take advantage of this growth and add value to physicians and patients by increasing your clinical knowledge about Vitamin D.
Here’s just some of what you’ll learn during this insightful 90-minute conference recording:
The basics of Vitamin D2 and D3.
The different testing methodologies, from immunoassay to mass spectrometry.
Insights into the sources of Vitamin D and how the body metabolizes it.
The most recent clinical studies linking Vitamin D insufficiency to a surprising number of diseases.
Why new research findings are changing the way many physicians manage Vitamin D in their patients.
The politics of Vitamin D in the scientific and payer communities.
The debate on what are sufficient/insufficient levels of Vitamin D.
How the choice of reference ranges for different Vitamin D test methodologies affects physician and patient response.
Why your own Vitamin D level may be under what’s necessary for optimal health.
The future demand curve for Vitamin D testing: Why more testing is likely.
…and much more!
This audio conference CD features expert Bruce Hollis, Ph.D., Professor of Pediatrics and Neonatology at the Medical University of South Carolina. He is recognized as the inventor of the first successful Vitamin A immunoassay in the 1980s and is a well-known international authority on Vitamin D. In fact, the depth and breadth of his insights about Vitamin D and its essential role in optimum health motivated a number of experienced pathologists and laboratory scientists to leave last year’sExecutive War College to purchase Vitamin D supplements!
Listen as Dr. Hollis provides details of recent clinical studies that will help explain how new knowledge about Vitamin D is changing the role it plays in a growing number of conditions and diseases. You’ll also learn which methodologies are being used to conduct Vitamin D testing and what the advantages and limitations are for each type of Vitamin 25(OH)D assay. And find out why the Vitamin 25(OH)D levels and reference ranges used to report the results generated by different Vitamin 25(OH)D test methodologies can confuse patients and physicians.
You’ll get the latest information on the vigorous debate going on about what level of Vitamin D should be used by clinicians to determine a patient’s sufficiency. Find out how the healthcare establishment picked an RDA number that-as clinical knowledge advances-is much too low to support optimum health. And how new clinical studies are providing persuasive evidence that the daily intake of Vitamin D should be closer to 5,000 units per day.
Understanding the changing science behind Vitamin D and why it is the fast-growing assay, by volume, on your lab’s test menu is critical to the future success of your lab. At the end of this session, you’ll come away with steps you can take that will help position your laboratory as a valuable resource on all aspects of Vitamin D testing.
The surging demand for Vitamin D testing has great clinical and financial importance for your laboratory. ORDER AUDIO CD NOW for “The A-to-Z of Vitamin D: Why It’s Today’s Hottest Lab Test!”
And don’t forget the question-and-answer session that allows you to hear relative questions to this world-renowned expert in vitamin D testing. This direct access will help you get advice and insight that’s tailored to the unique needs of your laboratory. So don’t wait! Order Your CD today for this very special program.
THE DARK REPORT AUDIO CONFERENCE AT A GLANCE
PLACE: Your telephone or speakerphone COST: $245 per digital CD recording TO ORDER CD: Call 512-264-7103
For one low price—just $245 per 90 minute CD—you and your entire team can take part in this fast-paced, insightful audio conference.
How to ORDER CD Now:
Call toll free: 512-264-7103
Your audio conference registration includes:
Downloadable PowerPoint presentations from our speakers
A full transcript emailed to you soon after the conference
Distinguished Presenter:
Bruce Hollis has studied vitamin D metabolism, molecular function and assay techniques for the past 35 years. He is a trained nutritional biochemist who has studied maternal and infant nutrition related to vitamin D for his entire tenure. He earned his Ph.D. in 1979 from the University of Guelph in Ontario, Canada. Hollis currently has active National Institutes of Health (NIH) projects investigating vitamin D requirements during pregnancy and lactation as well as its role in the development of childhood asthma and infection prevention.
ACCENT® Continuing Education Credit The American Association of Clinical Chemistry (AACC) designates this program for a maximum of 1.5 ACCENT® credit hours towards the AACC Clinical Chemist’s Recognition Award. AACC is an approved provider of continuing education for clinical laboratory scientists in the states of California, Florida, Louisiana, Montana, Nevada, North Dakota, Rhode Island, and West Virginia.
