Latest News in Rheumatology
2/7/2003
Hip Fracture Repair Yields Good Functional Outcome for
Less Than Half
U.S. Orthopedic Surgeons Face Liability Crisis
Antibiotics to Bear Resistance Warnings
H. Pylori Vaccine Approved as an Investigational New
Drug
FDA Issues Warning Letter to OxyContin Manafacturer
Greater Awareness of Bone-Marrow Suppression With
Methotrexate
Medscape Medical News -- Approximately 350,000 hip fractures occur every year in the
U.S. A new study reported at the 70th Annual Meeting of the American Academy of
Orthopaedic Surgeons says that although most of these patients (83%) survive for
at least one year after the fracture, only 41% regain pre-fracture condition.
Kenneth J. Koval, MD and colleagues at the Hospital for Joint
Diseases followed 1,000 hip fracture patients to determine pre-fracture function
and functional outcome after hip surgery. In order to focus on "issues that
the patients said were important", they assembled a list of questions
that addressed Basic Activities of Daily Living (BADLs) --eating, dressing,
bathing and toileting, etc. -- and Instrumental Activities of Daily Living (IADLs)
-- preparing shopping lists, shopping, cooking, and performing housework, etc.
The researchers specifically did not ask about pain.
Patients aged 85 years or younger who lived with another person were more
likely to gain BADL function, whereas age of 85 years or younger was the only
predictor for recovering IADL. Patients who were dependent before the fracture
were less likely to have a good outcome, and patients with more comorbid
conditions fared worse.
Unfortunately, these are factors that surgeons cannot control or influence.
Clinically, the only predictor of a good return to function was a fracture in
the femoral neck, which is also something that surgeons cannot control.
But Dr. Koval says that regardless of the limitations, "surgeons can
work as part of a multidisciplinary team to improve functional outcome". At
the Hospital for Joint Diseases, they have a specialized nursing pool for hip
fracture patients, as well as geriatricians, social workers, physiatrists, and
physical therapists who work together to help improve outcome. As part of this
team approach, Dr. Koval has developed a Functional Recovery Score (FRS), which
is a standardized instrument that measures the patients' pre- and post surgery
BADLs and IADLs. The doctors design a therapeutic plan based on the patient's
score. Using this approach, Dr. Koval says that most patients regain BADLs by 12
months, and 48% recover IADLs in this time period.
New Orleans, LA -- As reported at the American Academy of Orthopedic
Surgeons' (AAOS) annual meeting, U.S. orthopedic surgeons are facing a
professional liability crisis, which is jeopardizing patient care. Rising
medical insurance premiums are causing surgeons to avoid certain procedures, and
in some cases to avoid surgery altogether. This has led to physician walkouts in
protest.
"If doctors can't obtain insurance, patients can't get care," said
Dr. Michael Daubs (Las Vegas University Medical Center, NV). He is an orthopedic
surgeon in the center's trauma center, and last summer joined his colleagues in
a ten-day walkout, which led to the center being closed in protest over the
escalating cost of protecting themselves in lawsuits.
The problem of increasing medical insurance liability is affecting all specialties,
but orthopedic surgery is one of the hardest hit. The Medical Liability Monitor
shows that premiums for general surgeons increased by 25% in 2002, but a survey
conducted by the AAOS found that premiums for othopedic surgeons increased by
35% from 2000 to 2002. The survey also found that rising liability insurance
premiums have caused:
- 55% of orthopedic surgeons to avoid at least some procedures due to
liability concerns
- 39% to avoid performing spine surgery
- 21% to eliminate emergency room calls
- 6% to eliminate all surgery
- 5% to retire early
Another orthopedic surgeon, Dr. Paul Collins, says, "There are treatment
options available in other countries that are not performed in the U.S. due to
liability concerns.
Dr. Daubs believes that the key to rectifying this situation is
"comprehensive tort reform" like the Medical Injury and Compensation
Reform Act (MICRA) that California passed in the mid 1970's. MICRA instituted a
$250,000 cap on non-economic damages, such as pain and suffering, which has
seemed to stabilize the rate of growth of medial liability insurance premiums.
Presently, 18 other states also have caps on non-economic damages, and these
states generally have lower premiums than other states.
The AAOS believes these tort reform systems have helped resolve the problem
of professional liability, and have facilitated better patient care. They
support the consideration and adoption of such a system at the federal level.
The Associated Press -- The U.S. Food and Drug Administration (FDA)
has announced that by February 6, 2004, antibiotics will bear a big new warning
that overusing antibiotics makes them less effective. The FDA mandated that
doctors must be sure a patient is actually suffering a bacterial infection (not
a virus with similar symptoms) before prescribing antibiotics.
The government estimates that half of the 100 million antibiotic
prescriptions written in physician offices each year are unnecessary.
Oftentimes, doctors prescribe antibiotics for children with earaches caused by
viruses, or for adults with colds or viral coughs. But antibiotics have no
effect on viruses -- they only fight bacteria.
The FDA also will require antibiotics to bear warnings reminding doctors to
teach patients how crucial it is to take medications exactly as directed.
Patients should not stop taking the antibiotics before they finish the
recommended medication amount just because they feel better, or share pills with
anyone else.
Germs are growing increasingly resistant to antibiotics. Many common
infections no longer are treatable with old standbys like penicillin, and some
have become untreatable by every antibiotic on the market. Anytime antibiotics
are used, survivor germs can emerge stronger and spread.
The warnings will only be on the drugs' official label, and the FDA is
worried that few doctors read drug labels anymore so they are working on
additional ways to spread the word, including ads aimed at consumers.
Medscape Medical News -- The U.S. Food and Drug Administration (FDA)
has approved the investigational new drug application for Helivax, a vaccine designed
to prevent and treat infections caused by Helicobacter pylori (H. pylori), also
known as the "ulcer bug". This approval paves the way for patient
enrollment in new clinical trials involving Helivax for the first half of 2003.
Trials of Helivax in animal models have shown a good response.
H. pylori and nonsteroidal anti-inflammatory drugs (NSAIDs) are the
most important agents in the development of peptic ulcer disease, each causing
ulcers by different mechanisms. However, the interaction between H. pylori and
aspirin or nonaspirin NSAIDs (NANSAIDs) is extremely controversial. Although
studies have showed varying data on the topic, a recent analysis of the studies
concludes that H. pylori infection may increase the likelihood of ulcer bleeding
among users of aspirin or NANSAIDs.
Two-thirds of the world's population is infected with this bacterium,
including approximately 50% of Americans. It is recognized as the predominant
cause of ulcers and is associated with stomach cancers and cardiac disease. H.
pylori is the only bacteria classified by the World Health Organization as a
type 1 carcinogen; the American Cancer Society estimates there are more than
25,000 new cases of stomach cancer and more than 13,000 deaths per year.
Rockville, MD -- The U.S. Food and Drug Administration (FDA) has
issued a warning letter to Purdue Pharma-- manufacturer of the opioid painkiller
oxycodone (OxyContin)--slamming the company for two recent advertisements for
the drug that the FDA believes "grossly overstate" the safety of the
medication and promote it for uses "beyond which have been proven safe and
effective."
The FDA says Purdue removed from the two journal ads (published in the Journal
of the American Medical Association in October and November 2002) material
facts relating to the abuse liability and fatal risks of OxyContin, minimized
the risk of the product, and suggested that it can be used "in a much
broader range of pain patients than has previously been proven safe and
effective." They state: "Neither one of your ads presents...any
information from the boxed warning discussing OxyContin's potential for abuse
and the related considerations when prescribing the drug. Neither one of your
ads...presents any information from the boxed warning disclosing that the drug
can be fatal if taken by certain patients or under certain conditions. It is particularly
disturbing that your November ad would tout 'Life With Relief' yet fail to warn
that patients can die from taking OxyContin."
A spokesperson for Purdue, James Heins, says that the company stopped using
the ads immediately after receiving the letter, although some of the ads may
have appeared in print afterward because it was too late to stop them. Purdue
states: "The letter was the result of an honest misunderstanding, which we
regret, regarding the featuring of safety information already presented in the
brief summary that is part of the two new ads for OxyContin tablets." They
say that the boxed warning information was prominently referenced in bold print
on the front of each ad and printed in entirety on a subsequent page, but do
plan to work closely with the FDA "to ensure that our future promotion
fully complies with its expectations."
OxyContin has become one of the most abused prescription drugs on the U.S.
market in the short time it has been available. In July 2001, Purdue created a
boxed warning as part of the approval labeling for the tablets following
meetings with the FDA, and the company sent a "Dear Healthcare
Professional" letter to more than 800,000 healthcare professionals
explaining the revisions of the prescribing information. Last April, a report by
the U.S. Drug Enforcement Administration said the product was linked to 464 drug
overdose deaths in the past two years, although Purdue disputed this
figure.
West Bromwich, UK -- Two British hematologists say that doctors and
patients need to be more aware of the importance of sticking to the correct dose
of methotrexate and avoiding interacting drugs to prevent the risk of
bone-marrow suppression, which leads to a decrease in white blood cells, red
blood cells and platelets. Such reductions can in turn result in anemia,
bacterial infections and spontaneous or excess bleeding. Some people with
spondylitis are currently taking methotrexate as part of their treatment. Drs
Michael Sosin and Sunil Hands (Sandwell General Hospital West Bromwich, West
Midlands, UK) report in a recent BMJ issue of three cases of bone-marrow
suppression associated with methotrexate use at their hospital during a period
of four years.
The "unusual" weekly dosing regimen of methotrexate "can cause
errors...by patients or clinicians...sometimes resulting in death."
Bone-marrow suppression can occur even when there is no use of interacting drugs
or a dose error. Drs. Sosin and Hands stress the importance of folic acid
supplements, which may reduce the incidence of bone-marrow suppression, and has
not been shown to reduce the efficacy of methotrexate. None of the three
patients at these doctors' hospital had been taking folic acid before admission.
These patients (all with rheumatoid arthritis) "suffered considerable
morbidity, requiring prolonged admission and intensive treatment -- including
transfusion of blood products, intravenous antibiotics, and in one case,
treatment with growth factor." A fourth patient had been treating his
psoriasis with methotrexate obtained from a relative, but his information was
not fully described in this study. And two other cases of bone-marrow
suppression associated with methotrexate occurred at their hospital during that
time-period, both of which were fatal, but the details of these cannot be
reported because relatives of the deceased could not be traced.
In conclusion, the doctors say that regular monitoring of blood counts can be
helpful in picking up some cases of methotrexate toxicity, but "may not
prevent all episodes of bone-marrow suppression." They do not think that
more frequent blood monitoring will be of any use because of the rapid onset of
bone-marrow suppression. Drs Sosin and Hands say that oral folic acid may reduce
the incidence of this complication, but more importantly, patients and health
professionals "must be aware of the importance of avoiding interacting
drugs and taking the wrong dose."