CEO SUMMARY: Psychiatrist John J. Cannell, M.D., was in a unique position to see the noticeable upward shift in the Vitamin D results reported on his patients by Quest Diagnostics Incorporated over the past 24 months, along with the recent decline in test result levels in recent weeks. His Vitamin D Council and his newsletter, with 28,000 readers, became a public clearinghouse where physicians and patients could get information about why the two national labs were reporting different Vitamin D results.
BECAUSE OF A KEEN CLINICAL INTEREST in Vitamin D and its role in various diseases, John Jacob Cannell, M.D., quickly recognized that an upward shift in the results of Vitamin D tests performed on his patients had occurred. He also believed this upward shift, combined with what readers of his newsletter were reporting, made it possible that a major American reference lab was reporting what he described as “falsely elevated” Vitamin D levels to many patients across the United States.
Cannell is a psychiatrist, a Vitamin D researcher, and holds a position at Atascadero State Hospital in Atascadero, California, which is the nation’s largest hospital for the criminally insane. He is the founder of the Vitamin D Council (www.vitamindcouncil.org). His newsletter is read by 28,000 people.
Interest in Vitamin D
“Vitamin D caught my attention eight years ago as I worked with my patients,” recalled Cannell. “I realized Vitamin D is not a vitamin at all, rather the only known substrate for a potent steroid hormone that regulates 2,000 human genes. Over the next year, I came to slowly realize that Vitamin D deficiency is probably involved in most of the diseases of civilization.
“Seven years ago, I founded the non-profit educational organization, Vitamin D Council, so there could be a clearinghouse of information for healthcare professionals and patients,” noted Cannell. “I began publishing my theories in the newsletter, a year or so before they were published in refereed medical journals, including my theories about Vitamin D’s role in influenza and in the autism epidemic. I also began to closely monitor all my patients’ Vitamin D levels.
“I work at a hospital that treats some very dangerous individuals with severe mental illnesses,” stated Cannell. “Many of my patients have very dark skin, none have fatty fish in their diet, and many come from prison, having been in solitary confinement for long periods of time. My hospital uses Quest Diagnostics Incorporated for laboratory testing.
“When I began monitoring the Vitamin D levels of my patients, as you can imagine, their Vitamin D levels were very low, just what you would expect when a person has: very dark skin, minimal exposure to the sun and no Vitamin D in the diet,” said Cannell.
“Vitamin D is generally obtained in the diet only from fatty fish. Most other sources, including multivitamins, contain inconsequential amounts of Vitamin D,” Cannell added. “For the first seven years, Vitamin D levels for my patients were at the level I expected. They were very low.
“About a year and a half ago, I noticed Vitamin D test results were creeping upward,” noted Cannell. “A test result would come back with a 25-hydroxy-vitamin D of 50 for a patient with very dark skin, who had been in solitary confinement, taking no vitamins, and who had no Vitamin D in his diet. So a Vitamin D test result of 50 for this patient meant something was screwy.”
Having noticed this change at Atascadero State Hospital, Cannell learned of a similar change from readers who were monitoring the Vitamin D Council Web site. Cannell explained, “People started calling and sending e-mails, stating ‘Dr. Cannell, why are you concerned about Vitamin D levels? My doctor did a test from Quest Diagnostics. My level is 60 and I don’t get any Vitamin D in my diet. I don’t go out in the sun and I don’t take Vitamin D supplements. You’re a quack!’
Different Test Results
“After reading similar e-mails,” continued Cannell, “I began suggesting to these people that they get their Vitamin D levels checked by using Laboratory Corporation of America for the test. I started getting calls and e-mails from readers who would say, ‘It’s incredible! I had my levels checked at both Quest and at LabCorp. At Quest, it was 50 and my level at LabCorp was 25. What’s going on?’
“At the same time, I noticed that Vitamin D levels had gone up in my hospital,” said Cannell. “In July of 2008, I described these events in my newsletter, which had grown to 28,000 readers. The editorial I wrote caused a firestorm. A week later, at the annual meeting of the American Association for Clinical Chemistry, I was inundated by pathologists asking me questions about Vitamin D tests. I suggested that pathologists collect duplicate blood samples from the same patients, then send one to LabCorp and one to Quest and carefully save the results that each lab reported for Vitamin D levels.
No Charge For Retesting
“Two months later, I presented my paper on the role of maternal vitamin D deficiency as an environmental trigger for autism at an autism conference in San Diego. Physicians there told me that Quest was sending them stacks of letters for individual patients that would notify them that the Vitamin D lab tests needed to be redone. Quest was offering to perform retesting for these patients at no charge. I was amazed. I had no idea reference labs did recalls like this.
“From what I can tell, these letters requested patients be retested if their original test had been done anytime in the past year and a half,” said Cannell. “Also, it seems like a great number of physicians across the country who ordered the Vitamin D test from Quest during that time were sent these retest letters.
“I understand Quest is performing 500,000 Vitamin D tests per month, so there’s a huge number of tests involved,” added Cannell. “Which physicians got the letters and how many patients they actually recalled, I don’t know.
“There are a growing number of clinical studies that connect low levels of Vitamin D to an increasing number of diseases,” explained Cannell. “Go to Google News or PubMed and type in ‘Vitamin D’ plus any disease you want, then read what comes up. For example, a recent news report on a clinical study done in Germany says people with low Vitamin D are five times more likely to drop dead from a heart attack.
“Recent published studies link low Vitamin D levels with hypertension, Parkinson’s disease, virtually all cancers, depression, schizophrenia, stroke, multiple sclerosis, diabetes, dementia, even obesity,” said Cannell. “It’s very important that people not be told that their Vitamin D levels are okay when they’re not. That’s the real problem—falsely elevated test results.
“The Vitamin D Council continues to urge people to have tests done at both Quest Diagnostics and LabCorp and to send us the results,” said Cannell. “During the past two years, we saw a period of time when the Vitamin D test levels from Quest started sneaking up and then got unbelievably high. Now, in the past month or so, I noted that Quest’s Vitamin D results have come back down to where they would be expected to be. Readers now email me that the Vitamin D results they get from Quest are closer when compared to the results they get from LabCorp, although Quest’s results remain higher. Quest Diagnostics did a substantial patient recall on this test. That is an implied admission that there were issues and I respect them for taking that step.
Accurate Vitamin D Tests
“The Vitamin D Council simply wants all labs to perform accurate Vitamin D tests,” he added. “If a bias has to exist, we favor a test bias that understates—not overstates—the level, for a simple reason. We want more people treated for Vitamin D deficiency.
“The danger is the false reassurance a patient gets if an inaccurate test overstated their real level of Vitamin D,” explained Cannell. “In this instance, it means the patient won’t take action to increase his/her level of Vitamin D. By contrast, there is no clinical danger in telling someone their level is 10 ng, or even 20 ng, lower than it really is.”
Pathologists and laboratory executives should take note of another aspect to the Vitamin D story. When both physicians and patients were puzzled by discrepancies in the way Quest Diagnostics and LabCorp were reporting Vitamin D results, they found the Vitamin D Council on the Internet and used it as a clearinghouse.
These physicians and patients were first to publicly report widespread discrepancies with Vitamin D test results delivered by Quest Diagnostics. They shared insights about methodologies, such as mass spectrometry versus the DiaSorin immunoassay for Vitamin 25(OH) D. They also publicly discussed the details of how the lab company responded when it was contacted about these issues.
Cannell, too, played his role in this story. “I felt I needed to speak out about this situation,” he said. “It makes no sense that a psychiatrist at a state mental hospital, who runs a shoestrong non-profit organization on his weekends using a home computer, ends up doing quality control for Vitamin D testing in the United States. That makes no sense at all.”
Lab Industry Missed this Major Event, But Alert Physicians Were Warning Their Patients
MONTHS AGO, WHEN THE VITAMIN D COUNCIL recognized a significant upward shift in the level of Vitamin D results reported by Quest Diagnostics as compared to Laboratory Corporation of America, it published its assessment of the situation on its Web site and in a newsletter read by 28,000 people.
For pathologists and lab executives, these Web postings demonstrate how the Internet now functions as a news service. Reproduced below is one posting that the Vitamin D Council published in July 2008 to alert its readers to issues associated with Vitamin D testing conducted at Quest Diagnostics during this time period(http://www.vitamindcouncil.org/newsletter/2008-july.shtml):
Does it matter what reference lab my doctor uses?
Yes, it might make a huge difference. A number of methods exist to measure 25(OH)D in commercial labs. The two most common are mass spectrometry and a chemiluminescence method, LIAISON. The first, mass spectrometry, is highly accurate in the hands of experienced technicians given enough time to do the test properly. However, in the hands of a normally trained technician at a commercial reference lab overwhelmed with 25(OH)D tests, it may give falsely elevated readings, that is, it tells you are OK when in fact you are vitamin D deficient.
The second method, chemiluminescence, LIAISON, was recently developed and is the most accurate of the screening, high throughput, methods; LabCorp uses it. Quest Diagnostics’ reference lab uses mass spec. Again, both Quest and LabCorp are overwhelmed by 25(OH)D requests. The problem is that the faster the technicians do the mass spec test, the more inaccurate it is likely to be.
If your 25(OH)D blood test says “Quest Diagnostics” on the top, do not believe you have an adequate level (> 50 ng/ml). You may or may not; the test may be falsely elevated. Let me give you an example. A doctor at my hospital had Quest Diagnostics do a 25(OH)D. It came back as 99 ng/ml of ergocalciferol. He is not taking ergocalciferol (D2), he has never taken ergocalciferol, only cholecalciferol, and he is not taking enough to get a level of 99 ng/ml, 50 ng/ml at the most. His email to Dr. Brett Holmquist at Quest about why Quest identified a substance he was not taking went unanswered other than to say “any friend of Dr. Cannell’s is a friend of ours.”
Long story short: if your lab report says “LabCorp” on the top, it is probably accurate; if it says Quest Diagnostics, it may be falsely elevated. While LabCorp has also been overwhelmed with 25(OH)D requests, the LIAISON method they use is relatively easy to do and does not rely on technician skill as much as the mass spec methods do. I’m not saying this because I’m a consultant for DiaSorin, who makes LIAISON, I’m saying it because it is true. If you don’t believe me, get Quest to make me an offer to be their consultant at 10 times what DiaSorin is paying me and see how fast I turn Quest down. If Quest fixes their test, I’d love to consult. The ironic thing: I’ve made both Quest and LabCorp lots of money via this newsletter, the Web site, and by repeatedly telling the press that people need to know their 25(OH)D level, which has contributed to the skyrocketing sales of 25(OH)D blood tests.
Cannell Criticizes Home Brew And No Regulatory Oversight
“THE VITAMIN D COUNCIL SIMPLY WANTS QUEST DIAGNOSTICS INCORPORATED—and any other laboratories that produced inaccurate Vitamin D results—to fix those problems,” said John J. Cannell, M.D., Founder of the Vitamin D Council in Atascadero, California.
“Quest is a major player in laboratory testing. We want them to have accurate tests and do 10 million Vitamin D tests per month to help patients and physicians address the widespread deficiency in Vitamin D,” stated Cannell. “But why is a lab like Quest allowed to create it’s own in-house test when an FDA- cleared test kit is available, is widely used, and has a long history of accurate results? The immunoassay kit manufactured by DiaSorin has a track record with physicians and was used in almost every major clinical study of Vitamin D in the past couple of decades.
“It’s nuts that existing regulations allow a laboratory to create its own test and offer it to patients and doctors with little validation of accuracy, nor with any regulatory review,” declared Cannell. “After all, people’s lives are at stake! Look at the turmoil caused over the past 18 months by one big lab after it decided not to use the FDA-approved test and instead offer its own version of a Vitamin D test. Lack of regulation on this point is unacceptable.”