Joints That Last A Lifetime
Enclosed are scientific references to allow you to make more informed health care decisions. Please share them with your family and friends.
Table of Contents
- 3 Billion Dollar Hoax
- Arthritis Drug May Cause Liver Damage
- Arthritis Patients Turn to Chiropractic
- Avoid Long Term Tylenol and Aspirin or Advil Use
- Case Study Shows Chiropractic Benefit for Spinal Stenosis
- Doctors Warned of Adverse Effects of Remicade
- How Vioxx and Celebrex Increase Your Risk of Heart Attack
- Research on Multi-Billion Dollar Arthritis Drug Flawed
3 Billion Dollar Hoax
By Gina Kolata
An estimated 12% of Americans age 65 and older have osteoarthritis of the knee. Researchers are reporting today a popular operation for arthritis of the knee worked no better than a sham procedure in which patients were sedated while surgeons pretended to operate.
The operation from this study, arthroscopic surgery, is for the pain and stiffness caused by osteoarthritis and it is performed on about 650,000 people in the US every year, at a cost of about $5,000 per procedure, for a total cost of 3.3 billion dollars every year in the US.
It involves making three small incisions in the knee; inserting an arthroscope, a thin instrument that allows surgeons to see the joint; and then flushing debris from the knee or shaving rough areas of cartilage from the joint and then flushing it.
Tests of knee functions revealed that the operation had not helped, and those who got the placebo surgery reported feeling just as good as those who had had the real operation.
Dr. Baruch Brody, an ethicist at Baylor who helped design the study, described the surgery as a sham.
The study dealt only with arthroscopic surgery for osteoarthritis, not with other common knee operations.
The 180 participants in the study were randomly assigned to have the operation or to have placebo surgery in which surgeons simply made cuts in their knees so the patients would not know if they had the surgery.
The research began when an orthopedic surgeon at the Houston veterans' hospital, Dr. J. Bruce Moseley, who is now the team physician for Houston's two professional basketball teams, approached Dr. Wray suggesting a study that would compare washing the knee joint, with washing and scraping, in patients with arthritis.
Dr. Wray had a bolder idea.
"She said, `How do you know that what you are seeing is not a placebo effect?' "Dr. Moseley recalled. "My response was, `This is surgery.' She said, `I hate to tell you this, but surgery may have the biggest placebo effect of all.' "
Placebo studies of surgery are almost never done. Many doctors consider them unethical because patients could undergo risks with no benefits. Working with Dr. Brody, the ethicist, the group tried to make the placebo treatment no more dangerous than daily life. Still, of 324 consecutive patients who were asked to participate, 144 declined.
For those who agreed, the day of surgery meant being wheeled into an operating room
while neither they nor any of the medical staff knew what their treatment would be. When they were on the operating table, Dr. Moseley, who did all the operations, opened a sealed envelope telling him whether the patient was to have the surgery or not.
Those in the placebo group received a drug that put them to sleep. Unlike those getting the real operation, they did not have general anesthesia.
Dr. Moseley made small cuts in their knees to simulate an operation. He bent and straightened the knee and asked for surgical instruments, just in case the patient was partly conscious. An assistant sloshed water in a bucket to make the sound of a knee being flushed clean.
The paper in The New England Journal is accompanied by two editorials. One, by Sam Horng and Dr. Franklin G. Miller of the National Institutes of Health, asks whether placebo surgery is unethical. The controversy, they wrote, comes because doctors assume that patients in clinical research should not be put at risk if they cannot benefit, and placebo surgery involves risk.
But, they say, clinical research is different from medical therapy; its aim is not to help those in the study but to help future patients.
To be ethical, they say, a study with placebo surgery must meet three criteria: it must not place patients at undue risk; the benefits of learning whether the surgery works must be worth any potential risk to the patients; and the patients must give informed consent.
In the current case, they wrote, all those objectives were met and the study "exemplifies the ethically justified use of placebo surgery."
Arthritis Drug May Cause Liver Damage
Arava, the popular drug for rheumatoid arthritis has been linked to liver damage and at least 12 deaths. According to a story from the March 29, 2002 Intelihealth, the FDA has received at least 130 reports of severe liver toxicity linked to Arava use. The full toll according to the article was reported as including 56 hospitalizations and 12 deaths, said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen. Two of the deaths were people in their 20s. He also stated that this prescription drug for rheumatoid arthritis has been linked to dozens of serious liver injuries and 12 deaths and should be banned.
To date, the FDA has six times more reports of liver damage among Arava users than users of methotrexate (another popular arthritis drug), even though thousands more people use methotrexate. Last summer the American College of Rheumatology warned doctors to take special care in prescribing Arava, by repeatedly testing patients' livers for signs of harm.
"It is impossible to predict which patients will be at risk", said Dr. David Yocum of Arizona Health Sciences Center. "I do not believe that the general rheumatologist understands or has any knowledge about these serious and potentially life-threatening complications."
Why is this so surprising? Every medication has adverse reactions. When one is pulled off the market and replaced by another, the end result is the same.
Arthritis is caused by abnormal wear and tear from abnormal alignment. Realigning the joints of the body normalizes joint movement, and insures they last exactly as long as you do.
Arthritis Patients Turn to Chiropractic
The Annals of Internal Medicine (of all places) published the results of a survey of 232 people who had arthritis and were under a rheumatologists care. Of those 63% responded to the survey by saying they were using some form of "complementary care" as named by the study. Of those people 31% were using chiropractic. These numbers may themselves be grossly under reported as only 45% of the patients told their doctor about using the other forms of care.
These reported numbers translate to over 19% of the public who is seeing a rheumatologist is also seeing a chiropractor. And if less that half of the patients are telling their doctor about it the actual number may be twice as high.
Possibly the most impressive statistic was that 73% of those trying chiropractic found it helpful. The reasons given why people said they tried the non-medical care was to control pain, because they heard it helps, because it is safe, because it helped someone they know, and because their prescription medication wasn't working.
Avoid Long Term Tylenol and Aspirin or Advil Use
A questionnaire of over 35,615 male health professionals showed that after adjustment for age, physical activity, and energy-adjusted dietary fiber and total fat intake, regular and consistent use of NSAIDs such as aspirin, Advil and the host of prescription anti-inflammatory drugs and acetaminophen was associated with diverticular disease.
Arch Fam Med. May 1998;7:255-260
COMMENT: The association between these drugs and diverticular disease of the colon is new for me. However, what is not new, and what seems to be a frequent observation in the people I care for, is kidney damage due to using these two medications together. It is a relatively common cause of permanent damage to the kidney resulting in the kidneys to fail and the person to remain on dialysis or have a transplant. In fact, 15% of all people on dialysis are there due to the use of Tylenol alone or in combination with aspirin like drugs. So the caution is that you can use these drugs together for the short term, but you must be very cautious about using them together on a regular basis. A 1994 article in NEJM showed that taking more than one table a day of Tylenol or 1,000 tablets over an extended period doubles the risk of kidney damage.
Americans spend over 6.6 billion dollars on these types of medications every year. The most common reason they are taken is for arthritis. As mentioned previously nearly 30,000 people a year dies from using these medications. The bulk of these deaths are due to bleeding ulcers. There are alternatives to these medications. Glucosamine 500 mg three times a day works quite nicely for most degenerative arthritis and an herb from India called Boswellia serratia works for inflammatory arthritis like rheumatoid arthritis.
Case Study Shows Chiropractic Benefit for Spinal Stenosis
In the May 2001 issue of the Journal of Manipulative and Physiological Therapeutics (JMPT) is a case report of how chiropractic helped a patient with Spinal Stenosis. In this study a 78-year-old man had low back pain and severe bilateral leg pains. Lumbar spinal stenosis (LSS) is a condition resulting in narrowing of the spinal canal and pressure on the spinal cord and/or nerve roots. Degenerative changes are also common. The patient commonly has chronic low back pain and unilateral or bilateral leg symptoms.
The patient in this study was a 78-year-old man with acquired degenerative Lumbar Spinal Stenosis. The onset was slow and progressive with increasing low back pain of 2 years' duration and progressively worsening bilateral anterior leg pain of 4 months' duration. The patient described an "achy low back" pain with a belt-line distribution and an "electric," "sharp," and "crampy" pain along the front of the lower leg. The MRI study of his lower back reveled a narrowing of the spinal canal.
In this case the man underwent an initial course of chiropractic care for a two week period during which significant changes were noted by the patient. The conclusion of the case report demonstrates successful care of a patient with symptoms either caused by or complicated by central spinal cord stenosis.
Doctors Warned of Infection, Worsening Heart Failure, and Death in Patients Taking Remicade
Oct. 24, 2001 -- Earlier this month, drug maker Centocor sent letters to doctors and other healthcare workers to warn them of the following problems in some patients taking Remicade:
First, when the drug is used to treat rheumatoid arthritis and Crohn's disease, there have been serious cases of infection, including tuberculosis (TB), and fungal infections.
In some cases, the complications were fatal. After 84 instances of tuberculosis happened worldwide between Aug. 24, 1998 and June 30, 2001, and 14 people were reported to have died, a warning was added to the drug information to tell doctors to be watching for possible infections. Doctors are urged to give patients taking Remicade a skin TB test. And, in places where the fungal infection histoplasmosis is common, doctors are urged to weigh the possible benefits of taking this drug against the risk of serious infection.
See a copy of the warning letter to doctors outlining the infection warnings on the FDA web site.
Also in October, Centocor sent a warning letter to doctors to tell them about what researchers have found when people with moderate or severe congestive heart failure (CHF) took Remicade. In a study of 150 patients, more people with CHF died or needed to go to the hospital for worsening symptoms if they took the drug, compared to patients who did not get it. The risk seemed especially pronounced in people who received the higher dose of the drug: 10 mg/kg. Seven of the 101 patients given Remicade died, compared to no fatalities among those who received a placebo.
In the warning letter sent to doctors, Centocor warned:
- Patients with CHF should not start Remicade therapy.
- Those with CHF who are taking the drug to treat Crohn's disease or rheumatoid arthritis should be reevaluated.
- Doctors should consider stopping Remicade treatment in patients with CHF, but if they decide to continue, patients need to have their heart function closely monitored.
- In patients with worsening CHF, Remicade treatment should be stopped.
See a copy of the warning letter to doctors outlining the instructions about Remicade and CHF patients.
Brand name: Remicade
Generic name: Infliximab
How it works: This drug is a genetically engineered substance, grown from elements of the human immune system. It is designed to bind to some of the products that are produced when the body is injured. It is hoped that when Remicade binds, it prevents some of the damage that makes rheumatoid arthritis, Crohn's disease, and other inflammatory illnesses so severe. Since the body makes similar products as heart failure develops, scientists have been trying to determine if the drug can help CHF patients as well.
How Vioxx and Celebrex Increase Your Risk of Heart Attack
Research in mice suggests that a newer class of painkilling drugs called COX-2 inhibitors could trigger a chain of events potentially harmful to the cardiovascular system.
Researchers speculate, though, that their findings might explain the outcome of a recent major trial in which patients taking a COX-2 inhibitor -- the arthritis drug Vioxx -- had higher rates of heart attack and other cardiovascular complications compared with patients on naproxen.
Naproxen, used in painkillers such as Aleve, belongs to a group of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs), which includes many familiar painkillers such as aspirin and ibuprofen. Aspirin is also well known for its heart-healthy blood-thinning effects.
COX-2 inhibitors -- which besides Vioxx include the arthritis drugs Celebrex, among others -- are a newer type of NSAID shown to be easier on the stomach. Unlike older forms such as aspirin, they work by selectively blocking the COX-2 enzyme. Traditional NSAIDs inhibit both the COX-2 and COX-1 enzymes, and this is believed to underlie the gastrointestinal side effects that can come with the drugs.
But the new mouse research suggests that the selectivity of COX-2 inhibitors could create an imbalance that promotes blood clotting and blood vessel constriction.
COX-1 makes thromboxane A2, which promotes blood vessel constriction and "stickiness" in blood cells called platelets. COX-2 is the major source of prostacyclin, which helps prevent platelets from clumping and promotes blood vessel dilation.
The researchers hypothesized that the heart-healthy ways of prostacyclin might counter the ill cardiovascular effects of thromboxane A2 in the body -- meaning that blocking only COX-2, and therefore prostacyclin, could allow thromboxane A2 to go about its business unchecked.
The researchers found that mice without a PGI2 receptor -- which mimics the clinical effect of taking COX-2 inhibitors -- had an enhanced vascular response to injury and showed increased thromboxane A2 formation and platelet activation. This exaggerated response was canceled out in mice lacking both thromboxane A2 and PGI2 receptors
Recently Merck & Co. Inc., the maker of Vioxx, announced that the arthritis drug's labeling would be changed to state that it carries higher cardiovascular risks than naproxen -- a move required by the US Food and Drug Administration following the Vioxx-naproxen trial.
However, that labeling also highlights data from two other studies showing that Vioxx users had a lower rate of cardiovascular problems compared with study participants taking an inactive placebo, although the difference was not statistically significant.
Research on multi-billion dollar arthritis drug flawed
Arthritis affects nearly 43 million Americans, or about one of every six people. In Britain, an estimated eight million people suffer from the condition. In fact, it's one of the world's most common diseases.
Most experts agree that as the population ages, this number will increase dramatically. By 2020, 60 million people will be affected by arthritis in the U.S. alone.
To health care providers, this translates into a global health epidemic. To drug manufacturers, it means a huge market that can produce billions of dollars in revenue. That was undoubtedly one of the incentives for the pharmaceutical industry to develop a new generation of arthritis drugs, known as selective COX 2 inhibitors.
However, despite the claims of the drug companies, these drugs may not be any better than the over-the-counter pain pills traditionally used for symptom relief. Worse yet, they may pose far greater risks of adverse side affects.
Those were the conclusions of a team of researchers whose report was published in the June 2002 issue of the British Medical Journal (BMJ).
Many of the hyped-up claims for the COX 2 inhibitors were based on a study published in September 2000 which concluded that the COX 2 inhibitor, celecoxib, was associated with a lower rate of stomach and intestinal ulcers than two older drugs for arthritis. The drug companies widely publicized the results of this study.
Two brands of COX 2 inhibitors -- Pharmacia/Pfizer's Celebrex and Merck's Vioxx -- broke records for first-year sales when launched in 1999. By the end of the first year on the market, U.S. sales soared to nearly $2 billion for these two drugs alone. Celebrex and Vioxx are projected to produce U.S. sales in excess of $6 billion this year.
However, the COX 2 inhibitors have been linked to an increase in the risk of blood clots, heart attacks and strokes.
The BMJ report re-examined the original study and found that only the data for the first six months of the study were published. When all the data were considered, the published results appeared to be clearly flawed.
The BMJ researchers believe that an "industry independent" analysis of all trials of selective COX 2 inhibitors must be performed to include both published and unpublished data. They also called for the wide dissemination of the misleading results of the trial to be counterbalanced by the equally wide dissemination of the findings of the reanalysis according to the original protocol. "If this is not done, the pharmaceutical industry will feel no need to put the record straight in this or any future instances," they concluded.
Arthritis is an unnatural wear and tear of the joints that are designed to last as long as you do. They wear out prematurely and unevenly when the joints are out of alignment. Stay straight and stay strong and healthy in every way.