Blood-Test Labs Bypass Doctors, Spurring Debate

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March 12, 2002

Blood-Test Labs Bypass Doctors, Spurring Debate

By LAURIE TARKAN

Marilynn K. Yee/The New York Times

Dottye has blood drawn for tests to determine the medication level for

treatment of a thyroid ailment. Ms.

orders the blood tests through the Web site HealthcheckUSA, an independent

laboratory, then gets the results over the

Internet.

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People can order tests at Web sites like HealthcheckUSA.com or Questest.com

after having blood drawn at a laboratory.

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. 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 , 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. '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. said.

, 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. 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. 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 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. 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. "

http://www.nytimes.com/2002/03/12/health/policy/12SELF.html