The Latest News in Rheumatology
10/25/2002
Infectious Background of Patients with a History of Acute
Anterior Uveitis
Caution: Your Prescription Drug Dosage May Be Too
High
A Summary of Patients' Privacy Laws
Public Acceptance of Alternative Practitioners Grows
Researchers sought to study the infectious background of patients with a
history of acute anterior uveitis (AAU) and healthy control subjects. Although
they did not specify whether patients had spondylitis, uveitis is a common
condition associated with the disease.
M. Huhtinen and colleagues from the University of Helinski in Finland studied
sixty-four patients with previous AAU and sixty-four sex and age matched people
with no previous history of AAU. Antibodies Salmonellae, Yersiniae,
Klebsiella pneumoniae, Escherichia coli, Proteus mirabilis, Campylobacter jejuni,
and Borrelia burgdorferi were measured.
The researchers conclude that neither the prevalence nor the levels
of the antibodies studied differed in both the patients with acute anterior
uveitis and the control group.
They note that the data suggests the presence of a single or multiple
antibodies in patients with a history of AAU compared with patients with none or
few recurrences may be a sign of repeated infections, infection persistence, or
raised innate immune responsiveness.
Twenty percent of prescription drugs are marketed with instructions for
use that are later corrected by the manufacturer, almost always to lower the
recommended dose or to warn that the drug could be hazardous to certain
patients.
Georgetown University researchers released these findings to support
longstanding concerns that drugs are being studied at excessively high doses to
emphasize their effects, but then marketed at the same high doses to maximize
profits.
Some experts say that this may contribute to the high numbers of serious and
life-threatening drug side effects.
The Georgetown study examined the recommended doses of 354 prescription drugs
released from 1980 to 1999. After those drugs came to market, the instructions
on the label were corrected for 73 (21%) medications. Drugs with label
corrections came from all drug classes, including the potency drug Viagra, the
HIV drug AZT, and the antidepressant Prozac. But they did not study drugs that
are different from the ones recommended by manufacturers (like pain relievers)
or drugs that have been reintroduced in low-dose variants (like birth control
pills), so these figures represent a low-end estimate of the number of drugs
with dosage corrections after they have been on the market.
80% of the corrections involved a reduction in the original dose or a new
restriction for certain groups of patients, such as those with liver or kidney
disease or those taking certain other medications.
Interestingly, they found that drugs approved by the FDA through its
so-called fast-track system adopted a decade ago for lifesaving compounds seemed
no more likely to have corrections than other drugs.
Drug companies say that the high rate of label corrections indicates the
progress of science. "The central issue is that we're constantly learning
about a drug throughout its life cycle," said Dr. Alan Goldhammer,
associate vice president at Pharmaceutical Research and Manufacturers of
America. "We can't know everything about a drug before it goes to market.
That would mean long regulatory delays and the American public would not want
that." Even the largest clinical trials cannot identify all the possible
patterns that emerge when drugs are used by millions of people.
Georgetown found that dosage corrections occurred after an average of 16
years on the market for drugs released from 1980 to 1984, but after only 3 years
for drugs released from 1995 to 1999. Some say that the recent surge of label
corrections may reflect more vigilance from manufacturers and the FDA to find
early dosage problems and correct them.
Similar results were found in a European study for drugs marketed there. Dr.
John Urquhart, professor of pharmacoepidemiology at Maastricht University in the
Netherlands and an author of the European study comments: "We can't say if
it's the mistakes that are happening at a rising rate or if it's the mechanisms
for finding them that are getting better."
Dr. Carl C. Peck, an author of this Georgetown study, say that a policy of
"start low and go slow" may be the best for many patients when first
taking a prescription medication. Doctors should require frequent visits to
check the patient's response, and adjust the dosage accordingly. Peck
says that in the future, genetic-based analysis of a patient's metabolic
idiosyncrasies may help streamline this process.
But the Georgetown study does not touch on the subject that Dr. Jay S. Cohen
(associate professor of family and preventative medicine at the Univeristy of
California, San Diego) finds that most important -- 75% of serious side effects occur at recommended
doses. He argues that for many people, the
recommended doses were much to high because doses are based on small studies
done on "young, health people, usually men." And people vary in size,
shape, age, patterns of metabolizing drugs, and concurrent illnesses, so the
notion of a single optimal treatment "makes no sense." Furthermore,
Cohen says that "If a dose is reduce 7 or 10 years after the drug was first
marketed, you wonder how many side effects, what great costs to patients and to
the medical system could have been avoided."
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a
federal law covering patient privacy issues as relating to health information
created or maintained by health care providers who engage in certain electronic
transactions, health plans, and health care clearinghouses.
The Department of Health and Human Services' Office of Civil Rights has
posted nearly two dozen frequently asked questions on its web site to assist
providers, payers, and other covered entities on patients' privacy laws.
Examples of such questions are:
- If patients request copies of their medical records, as permitted under
the HIPAA privacy rule, can a covered entity charge for the copies?
Yes, the privacy rule permits a covered entity to impose reasonable,
cost-based fees to handle patient requests for medical records. The fee can
only cover the cost of copying (including supplies and labor) and postage if
the patient requests that the records be mailed. The fee cannot include
costs associated with searching for and retrieving the requested
information.
- Will the privacy rule permit a provider to disclose a complete medical
record if portions of the record were created by other providers?
Yes, as long as the disclosure is for a purpose permitted under the rule,
such as treatment.
- Can hospitals inform the clergy about parishioners in the hospital?
Yes, as long as the patient has been informed of this use and disclosure of
information and does not object.
For the full list of frequently asked questions, go to www.hhs.gov/ocr/hipaa
and click on "What's New."
According to some studies, 43% of Americans have used some form of
alternative or complimentary medicine, and are spending $40 billion a year on
such treatments.
"The trends are clear," says Michael Traub, ND, president of the
American Association of Naturopathic Physicians (AANP). "People are not
getting what they need with conventional physicians...they are looking for forms
of medicine that are less invasive, less harmful, and have fewer side
effects." AANP estimates there are 4,000 to 5,000 naturopathic
practitioners in the U.S. who have graduated from one of five accredited
colleges in the U.S. and Canada.
But most physicians remain firm in their opposition to using state
legislatures to expand naturopathic scope.
"We believe the way to become trained is by education not
legislation," said John C. Nelson, MD, secretary-treasure of the American
Medical Association. But Dr. Nelson acknowledges that many people with terminal
or chronic illnesses are turning to unproven alternative therapies when they
feel their traditional avenues of treatment have been exhausted, and that
managed care constraints have forced some doctors to be rushed with their
patients, all of which make some people turn to naturopaths and others who are
able to time with their patients.
Kansas is the latest state to pass legislation regulating who is qualified to
practice naturopathy and who is not. A licensed naturopathic practitioner
attends a four-year graduate level program and is educated in basic sciences and
holistic approaches with an emphasis on disease prevention. Studies include
clinical nutrition, acupuncture, homeopathic medicine and botanical medicine.
Some physicians work together with naturopaths in practicing what they would
call the "best" medicine available. Dr. Bethany Hays, an ob-gyn who is
medical director for True North in Falmouth, Maine says she values that
naturopaths spend time educating patients on health eating and lifestyles.
Patients with complex multisystem disorders like chronic fatigue, fibromyalgia,
and irritable bowel syndrome often benefit because "these are problems
conventional doctors don't have much patience or time for and often don't fee
like they're helping."
States that require naturopath licensing: Alaska, Arizona, Connecticut,
Hawaii, Maine, Montana, New Hampshire, Oregon, Utah, Vermont, Washington
States that require registration: Kansas, District of Columbia
Source: American Association of Naturopathic Physicians, American
Naturopathic Medical Association