Quest Acknowledges Errors in Vitamin D Tests

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Quest Acknowledges Errors in Vitamin D Tests

By _ANDREW POLLACK_

(http://topics.nytimes.com/top/reference/timestopics/people/p/andrew_pollack/ind\

ex.html?inline=nyt-per)

Published: January 7, 2009

The nation’s largest medical laboratory company provided possibly erroneous

results to thousands of people who had their _vitamin D_

(http://health.nytimes.com/health/guides/nutrition/vitamin-d/overview.html?inlin\

e=nyt-classifier)

levels tested in the last two years, the company has acknowledged.

(http://www.nytimes.com/2009/01/08/business/08labtest.html?_r=1 & emc=eta1#secondP\

aragraph)

_Quest Diagnostics Inc_

(http://www.nytimes.com/auth/login?URI=http://www.nytimes.com/2009/01/08/busines\

s/08labtest.html)

_Go to your Portfolio »_

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The company, _Quest Diagnostics_

(http://topics.nytimes.com/top/news/business/companies/quest_diagnostics_inc/ind\

ex.html?inline=nyt-org) , has already sent

letters to thousands of doctors listing the patients who might have received

“questionable†test results and is offering free retests. The company said

it had fixed the problems.

An erroneously high result may mean patients will not take vitamin D

supplements when perhaps they should, doctors said. And an erroneously low test

result might lead in rare instances to a toxic overdose of vitamin D. When the

Quest tests have been inaccurate, the reading has typically been too high,

although not in all cases.

Quest’s action represents “the largest patient test recall I’m aware of in

my 20 years in the business,†said L. Michel, editor of _The Dark

Report_ (http://www.darkreport.com/) , a newsletter for pathologists that first

reported on Quest’s action.

The incident could raise calls for more regulation of diagnostic testing at a

time when diagnostics are playing an increasingly crucial role in guiding

medical treatment. Many laboratory tests, including Quest’s vitamin D test, do

not require approval from the _Food and Drug Administration_

(http://topics.nytimes.com/top/reference/timestopics/organizations/f/food_and_dr\

ug_administrati

on/index.html?inline=nyt-org) .

The incident also raises questions about vitamin D testing, which has surged

because studies have suggested that a deficiency of the nutrient raises the

risk of bone weakness, _cancer_ (ht

tp://health.nytimes.com/health/guides/disease/cancer/overview.html?inline=nyt-cl\

assifier) , heart attacks, autoimmune

diseases and other illnesses. Quest and other laboratories have reported that

in

some cases test volumes had nearly doubled from one year to the next.

_Medicare_

(http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/med\

icare/index.html?inline=nyt-classifier) pays about $40 for a vitamin D

test, though doctors say some of their patients were billed as much as $200

for the Quest test.

But experts say that so far there is no standardization of the tests, meaning

that results can differ considerably from one laboratory to another.

That can make it hard for doctors to decide on treatment and for experts to

compare studies aimed at determining the optimal level of vitamin D in the

blood. “If you get your vitamin D level measured in the _Mayo Clinic_

(http://topics.nytimes.com/top/reference/timestopics/organizations/m/mayo_clinic\

/index.ht

ml?inline=nyt-org) , the Cleveland Clinic and the Timbuktu Clinic, it would

be nice if it came out the same value,†said Dr. Neil C. Binkley, associate

professor of medicine at the _University of Wisconsin_

(http://topics.nytimes.com/top/reference/timestopics/organizations/u/university_\

of_wisconsin/index.html

?inline=nyt-org) .

Dr. Binkley said that a few years ago he sent a sample of his blood to six

laboratories and got results that ranged from 14 nanograms a milliliter, which

would be a deficient level, to 41 nanograms — a level three times as high and

considered adequate. While the tests’ consistency has improved since then,

there can still be substantial variability, he said.

Yet many experts say that even if the tests were accurate, there would still

be uncertainty in how to treat patients. There is considerable debate about

how much vitamin D is needed and whether vitamin D supplements even prevent

various diseases. Vitamin D is usually made by the body when the skin is

exposed to sunlight and is also contained in oily fish and some fortified

drinks

like milk.

Some doctors said they had switched to other testing laboratories because of

Quest’s problems. But Quest, based in Madison, N.J., offers numerous tests,

from routine blood work to sophisticated genetic tests. No one type of test

represents a large potion of its revenue, which was $5.45 billion for the first

nine months of 2008.

The company said the retesting would not have a material effect on its

earnings. The company’s stock price rose 80 cents Wednesday to $49.20,

approximately in the middle of its 52-week range.

Quest’s problems with the vitamin D analysis arose after it shifted in 2006

and 2007 to a new test of its own design, replacing an older F.D.A.-approved

test. The new test promised to be more accurate and offer more detailed

information, Quest executives said. But the test relied on a sophisticated

instrument called a mass spectrometer, which can be tricky to use, especially

for

high-volume testing.

Dr. Wael A. Salameh, the medical director for endocrinology at Quest’s most

sophisticated laboratory, which is in San Capistrano, Calif., said some

materials used to calibrate test results had been faulty. And four of the

seven Quest testing laboratories around the country did not always follow

proper

procedures, he said.

Quest would not say how many patients were affected. But a spokesman did not

deny that thousands of doctors were sent letters in October. Each doctor had

at least one patient, and in many cases dozens of patients, who had a

possibly inaccurate test result.

Dr. Salameh said the inaccurate results represented less than 10 percent of

all the vitamin D tests done by Quest from early 2007 to mid-2008. And even

many of the possibly inaccurate results were probably accurate, he said,

because Quest sent letters even if there was only a remote chance that the test

was

erroneous.

“We are kind of being penalized for going the extra mile,†he said.

Dr. L. Hoffman, a clinical nutritionist in New York City, said his

letter from Quest mentioned about two dozen of his patients. “There was a

patient we put on vitamin D and all of a sudden, for the first time ever, the

patient came back with what seemed to be a toxic level of vitamin D,†said Dr.

Hoffman, who is also host of a radio program on health, on WOR in New York City.

When the patient was given a different vitamin D test, the value was

considerably lower.

Dr. Lawrence D. Rosen, a pediatrician in Oradell, N.J., who treats many

_autistic_

(http://health.nytimes.com/health/guides/disease/autism/overview.html?inline=nyt\

-classifier) children, said his letter named more than 20 patients

and that retesting was an inconvenience. “A lot of these kids, especially if

they’re autistic, it’s a big deal for parents to have their blood drawn,â€

he

said.

One question is why Quest’s problems took so long to discover. Some doctors

who advocate vitamin D use said they had begun noticing some unusually high

test results in 2007 and had begun complaining publicly in the summer of 2008.

One of them was Dr. J. Cannell, a psychiatrist at a California hospital

for the criminally insane who started the Vitamin D Council to promote use of

the vitamin. He said that after the test was introduced, he started noticing

that some patients had normal levels of vitamin D, a departure from the

past, when the levels had often been low.

“A black man coming from solitary confinement on C.D.C.R. food cannot have a

normal level of vitamin D,†he said, referring to the California Department

of Corrections and Rehabilitation. People with dark skin do not convert

sunlight to vitamin D as easily as those with lighter skin.

Quest executives say they dismissed the concerns of Dr. Cannell because he

was a paid consultant to DiaSorin, a company that makes a rival test.

They said the company’s review of its testing results had instead been

prompted mainly by its own review of national health trends based on Quest data,

which had shown an unusual rise in average vitamin D levels.

Meanwhile, the F.D.A. is considering increasing its role in regulating

diagnostic tests. Now, test kits sold to labs, _hospitals_

(http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/hos\

pitals/index.html?inlin

e=nyt-classifier) and doctor’s offices must be approved by the agency. But

tests developed and offered by a single laboratory, like the Quest vitamin D

test, do not.

Quest and many other laboratories argue that lab quality is already regulated

through Medicare and that having to win approval for each new test will slow

innovation and raise costs.

Jan Patenaude, RD

Certified LEAP Therapist

Consultant, Speaker, Writer

Director of Medical Nutrition

Signet Diagnostic Corporation

(Mountain Time)

(toll free)

Fax:

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