n
a suburban strip mall midway between downtown Denver and health-conscious
Boulder, there is a place where people can go and order blood tests to
detect any number of medical problems, like high cholesterol, diabetes,
H.I.V. and prostate and ovarian cancer.
It is neither a doctor's office nor a traditional laboratory that
requires a physician's referral for medical tests. It is a retail store,
where all that people need is cash, a check or a credit card to find out
what ails them.
The store, called QuestDirect and owned by Quest Diagnostics, the largest
diagnostic laboratory in the United States, is one of a growing number of
direct-to-consumer laboratories that are opening up across the country and
on the Internet.
In addition, an estimated 10 to 15 percent of existing commercial and
hospital laboratories are now offering testing directly to consumers,
without a doctor's referral, said Jondavid Klipp, managing editor of
Laboratory Industry Report, a trade publication.
"We're potentially entering a retail era where companies are marketing
and selling testing services directly to the consumer," said Dr. Bruce A.
Friedman, a pathology professor at the University of Michigan Medical
School. "The number of people doing this is minuscule but, in fact, a lot of
people are paying attention to it because there is a movement toward these
retail labs."
The trend worries many doctors, who question the medical implications of
patients' trying to diagnose their own conditions and interpret their own
test results. They also question the legality of these direct-to-consumer
laboratories.
"Trying to interpret lab tests is a very complex and very specialized
thing and requires knowledge far beyond the usual layperson's ability," said
Dr. J. Edward Hill, chairman-elect of the American Medical Association's
board. "It's unfathomable that people are going to order tests that take
years of medical training to understand."
Many states have laws preventing patients from ordering their own tests
and receiving results without a doctor's requisition. Direct-to-consumer
laboratories in those states sometimes follow the letter of the law but not
the spirit, skirting the laws by hiring doctors to sign the requisitions,
usually without ever seeing the patients.
To get tested, people can walk into one of the storefront laboratories.
Or they can order their tests online at Web sites like HealthcheckUSA.com or
Questest.com, and then have their blood drawn at a local traditional
laboratory. People can also buy at-home tests, which are then mailed back to
the laboratory for analysis.
Popular tests include screening for cholesterol and other heart disease
markers, H.I.V., Lyme disease, thyroid problems, liver and kidney function,
prostate and ovarian cancer, allergies and sexually transmitted diseases.
Some people use self-testing laboratories to screen themselves for
recreational drugs before they submit to an employer's drug test.
Dottye Howard, 49, of New York City, says ordering her own blood tests
has improved her thyroid problem. The thyroid test she takes every six to
eight weeks helps her and her doctor adjust the medications so she has
optimal levels in her body. Ms. Howard's managed care company refused to pay
for the tests, so she orders them directly from HealthcheckUSA for $79 out
of pocket, less expensive than if her own doctor had ordered the tests.
After receiving by fax or mail a doctor- signed requisition from the Web
site, she takes a bus or a cab to a local laboratory and gets her blood
drawn. Two days later, she can download her results from the Internet, call
her doctor and discuss whether to increase or decrease her medications.
"Getting the meds optimized has really improved my quality of life and
that could not be done, in my opinion, without the access to these tests,"
Ms. Howard said.
Sandra Thomas, president of American Hemochromatosis Society, said she
advised people with family histories of hereditary hemochromatosis, an iron
overload disease, to order their own tests if their doctors refused to
screen them for the disease. She said self-testing had probably spared the
lives of several people she knew. In those cases, the people learned that
they had the disease early enough to be successfully treated.
Proponents of self-testing believe it gives patients more control over
their health and may help in the early diagnosis of diseases. Some patients,
particularly the uninsured, may never seek health care and may have diseases
that go undiagnosed, said Dr. Richard Abrams, an internist in Denver. A
simple, inexpensive test can catch common diseases like diabetes, high
cholesterol and hepatitis C early, he said.
Self-testing is an extension of the screenings conducted at health fairs,
at malls or through corporate wellness programs, Dr. Friedman said. People
also test themselves on a limited basis with home health tests, like
pregnancy tests and glucometers for diabetes.
But critics worry that even a well-informed consumer outside the medical
field is not educated enough to understand the results of many tests. "The
problem is you need a doctor to read the tea leaves and put it in the
context of your overall health," Dr. Abrams said.
Blood tests are not the only factor in making many diagnoses. "The first
thing I try to teach medical students is that about 90 percent of diagnoses
can be made accurately by taking a good history and good physical exam," Dr.
Hill said. "When you do testing, it is to confirm your suspicions."
Direct-to-consumer testing starts the process where it should end, he said.
The College of American Pathologists, whose members work at commercial
and other laboratories, takes a cautious position on the issue. "We have
concern about the lab tests being ordered by an individual who may not fully
understand the consequences of the test and the potential pitfalls in test
interpretations," said Dr. Paul Bachner, past president of the organization.
The group's biggest concern centers on false negative results, in which a
test does not pick up an existing problem. "Patients may have symptoms, but
will conclude that if the test is normal, they don't have that condition and
don't seek out medical care," Dr. Bachner said.
A physician caring for such a patient, he said, may recognize
discrepancies between the symptoms and the results and repeat the test or
order others. On the other hand, false positives can lead people to have
more tests or unneeded procedures.
QuestDirect, HealthcheckUSA and other independent laboratories say they
encourage customers who have abnormal results to see doctors. When result
are significantly out of the normal range, the companies contact the
consumers to let them know they should see their doctors immediately.
"We're very careful to let people know that they should use this
information in the context of an overall relationship with their personal
physician," said Hughes Bakewell, vice president of consumer health for
Quest Diagnostics, a $4 billion publicly traded company, which opened eight
QuestDirect laboratories across the country, all in states where laws do not
prohibit self-testing.
"Typically, people who do this on their own are proactive anyway and it's
highly likely they'd act on it," Mr. Bakewell said. No laboratories seem to
have done follow- ups on what patients do with the information.
He said typical customers were people who wanted to monitor problemss
like high cholesterol and diabetes. But perfectly well people who are
health-conscious make up a significant portion of self-testers.
"They're the worried well," said Dr. Henry Soloway, who pioneered
direct-to-consumer health testing nearly two decades ago in Las Vegas.
"They're wondering how they're doing. They're somewhat sophisticated and may
have a specific question they want an answer to."
There are also those who choose self- testing so their results do not
show up on their medical records.
Others use the laboratories to save time. Dr. John Halsey, a clinical
immunologist in Kansas City, Kan., who started a direct-to- consumer
laboratory and then sold it to Quest, said: "Traditionally, if you wanted
your cholesterol taken, you'd have to go to the doctor, sit in his waiting
room for a half hour. He'd order the test, then you'd have to go to the lab
and get the blood drawn. Now, patients can be in and out in 15 minutes."