Oct
01
2004

What Went Wrong With VIOXX

Merck &. Co., Inc. announced on Sept. 30, 2004 that VIOXX® (rofecoxib), an arthritis and acute pain medication, would be withdrawn voluntarily worldwide. VIOXX was FDA approved as a new anti-inflammatory drug for osteoarthritis in 1999. Later it was also cleared for rheumatoid arthritis. As a Cox-2 inhibitor it was different from aspirin and the conventional anti-inflammatory drugs such as Naproxen, Motrin or Voltaren.

In a study called VIGOR , which is detailed more under this link, VIOXX was compared to Naproxen in terms of gastrointestinal side-effects. It was found that the risks of bleeding ulcers, perforation and bowel obstruction were 50% reduced (frequency of cases with naproxen 1.22% versus VIOXX with a frequency of 0.52%). Surprisingly, in this study of 4000 patients over 1 year the cardiovascular risks such as heart attacks, strokes, blood clots for VIOXX was 1.8%, 3-fold higher than Naproxen, which had only 0.6% such complications. In addition it was noted that high blood pressure was more common in rheumatoid patients. The FDA made Merck add a warning on the drug label regarding these added risks, but this went more or less unnoticed by the public.

It has been known for some time that aspirin (ASA) has polyp preventative action on the colon and thus reduces the risk of colon cancer. A specific study, called APPROVe (Adenomatous Polyp Prevention on VIOXX) trial, was designed to show that VIOXX could do the same as aspirin, but with less toxic side effects. In 2000 Merck started enrolling patients into this 3 year long trial.

What Went Wrong With VIOXX

What Went Wrong With VIOXX

After 18 months into the trial cardiovascular side-effects started to show up that were statistically significant when compared to controls. This is what prompted the recent press release that VIOXX would be taken off the market altogether.

More info on treatment of osteoarthritis: http://nethealthbook.com/arthritis/osteoarthritis/treatment-osteoarthritis/

Comments: One of the potential problems with receptor specific medications is that they can be so specific that the metabolism in the human body is changed. What’s good for the gut may not be good for the circulation, blood pressure and the heart. Merck did the right thing to withraw the medication altogether. It is not known at this time whether other similar medications such as Celebrex, which has a different molecular configuration, will stand up in the future to post-marketing testing.

Addendum on Nov. 6, 2012: In 2005 Bextra was also taken off the market by the FDA, but Celebrex was allowed to stay, but required to label their product with warnings about potentially serious side-effects.

Last edited October 27, 2014

Aug
01
2004

Uric Acid Blood Test Predicts Future Health Problems

A 12 year prospective, well controlled follow-up study from Finland determined that uric acid blood tests are not only useful in following patients with gout or kidney stones, but are also predictive for future health problems including death. Dr. Leo K. Niskanen from Kuopio University in Finland and colleagues followed 1,423 middle-aged Finnish men who at the beginning of the study were free from cancer, heart disease, strokes and diabetes. After about 12 years the researchers found that 157 men had died, 55 from heart disease or strokes. When men with elevated uric acid levels were classified into low, medium and high levels, an interesting observation was made when subclasses were compared with each other. Those men in the upper range of uric acid levels had a risk of more than 2.5-fold to die from a heart attack or stroke when compared to men with uric acid levels in the lower range. Also, men in the higher range were 1.7-fold more at risk to die from any cause than men in the lower range of uric acid levels.

Dr. Niskanen said that uric acid simply seems to be another good marker for spotting troubles in health. The mechanism of this connection is not known at this point in time, but the test is easy to do and is very useful in screening a middle aged population.

Risk of Developing a Heart Attack or Stroke with Elevated Uric Acid Blood Test

Uric Acid Blood Test Predicts Future Health Problems1

Uric Acid Blood Test Predicts Future Health Problems

 

 

 

 

 

 

 

 

 

Other investigators in the past have also observed a similar association, but this seems to be the first longterm and prospective study.

More info on:

1.heart attacks: http://nethealthbook.com/cardiovascular-disease/heart-disease/heart-attack-myocardial-infarction-or-mi/

2. strokes: http://nethealthbook.com/cardiovascular-disease/stroke-and-brain-aneurysm/

3. Gout: http://nethealthbook.com/arthritis/gout/

Reference: Arch Intern Med 2004;164:1546-1551

Last edited October 26, 2014

Jul
01
2004

Beer A Red Flag For Gout

For centuries gout has been known as the affliction of the affluent. The Greek physician Hippocrates first described it as “the disease of the kings”. In the meantime the illness has jumped social boundaries, as the over consumption of meats and alcohol will occur in all population groups.

In its April 17 issue the British medical paper”The Lancet” shows the first publication on the link between alcohol and gout. Dr. Hyon Choi of the rheumatology unit of the Massachusetts General Hospital, Harvard Medical School, headed a study that showed that moderate amounts of wine did not pose a risk for gout. It was the beer drinkers that were headed for trouble! Those who drank more than two 350 ml cans or bottles of beer per day had a 2.5 times higher risk of developing gout than nondrinkers. People who had 2 shots of liquor a day ran a risk that was 1.6 times higher than those who did not drink. Moderate wine drinkers had the same risk of developing gout as nondrinkers, as long as they did not overindulge: 1 to 2 glasses of wine per day were the limit! It is not clear at this point, which would be the noxious substance in beer and spirits that is responsible for attacks of gout, and moderation is still in order for all wine lovers!

Beer A Red Flag For Gout

Beer A Red Flag For Gout

More info about gout: http://nethealthbook.com/arthritis/gout/

Reference: National Review Of Medicine, May 15,2004, pg.10

Last edited Oct. 26, 2014

May
01
2004

Chronic Inflammation Causes Cancer, Heart Attacks And More

When the Time Magazine devotes 7 full pages in the March 22, 2004 issue to the topic of inflammation as the source of most of the diseases of the Western World, you know that something important is happening in medicine. Christine Gorman and Alice Park have summarized some of the groundbreaking research of the past few years in this article. I will report about this article here, but also include direct links regarding some of the relevant research the authors have mentioned including some of the key links regarding the metabolic syndrome, which was not mentioned in the article.

Since the beginning of the obesity wave in North America it has become obvious that a cluster of diseases such as heart attacks, strokes, Alzheimer disease, cancer of the colon, multiple sclerosis, arthritis and others have also become more frequent. Dr. Paul Ridker, a cardiologist at Brigham and Women’s Hospital, was one of the pioneers of investigating inflammation as a possible cause and the common denominator of these diverse illnesses. He noticed that certain patients got heart attacks although their blood LDL cholesterol levels (the “bad” cholesterol) were normal. The theory at that time was that all patients who would develop heart attacks would come from a high-risk group of patients with elevated LDL cholesterol. The problem was that 50% of patients with heart attacks had normal LDL cholesterol levels. Dr. Ridker suspected that the C-reactive protein (CRP), which is found to be elevated in the blood of rheumatoid patients, would be somehow involved in the disease process of hardening of the arteries before a heart attack would occur. CRP is produced by the liver cells and by the lining cells of arteries in response to a general inflammatory reaction in the body. Examples of this would be rheumatoid arthritis patients and patients with autoimmune diseases, where CRP levels can be readily measured with a blood test. Dr. Ridker found that there was a very good correlation between the CRP level and the degree of inflammation as well as the risk for developing heart attacks and strokes. Further investigation by others confirmed that CRP levels were perhaps more important than LDL levels in predicting impending heart attacks. This is so, because CRP is the body’s substance in the blood stream that would be responsible for breaking up LDL containing deposits (plaques) in the walls of the arteries, which leads to heart attacks in the heart and to strokes in the brain.

Chronic Inflammation Causes Cancer, Heart Attacks And More

Chronic Inflammation Causes Cancer, Heart Attacks And More

Other investigators found that CRP was only one link in a complex chain of events that includes inflammatory substances (cytokines) from the fat cells as well as insulin and insulin-like growth factors from the metabolic syndrome. Leptins are also a factor as has been discussed under this link.
Dr. Steve Shoelsen from the Joslin Diabetes Center in Boston has developed a mouse model for the metabolic syndrome. These mice will produce huge amounts of inflammatory substances in their fatty tissue in response to any inflammatory process that is started in them. Anti-inflammatory drugs such as the statins or metformin, it is hoped, will be shown conclusively to dampen the inflammatory process and prevent heart attacks, strokes and diabetes as well as cancer, Alzheimers disease and arthritis. Heart disease has already been shown to be improved by anti-inflammatory drugs. Asthma is an inflammatory disease of the small bronchial tubes, which can be stabilized with the anti-inflammatory drug Avastin.

What can we do as consumers to prevent some of those life-threatening diseases? By reducing our weight through calorie restriction on a low-glycemic diet we can help to reduce the insulin-like hormone substances of the fatty tissue. Regular exercise of at least 30 minutes of a brisk walk daily or the equivalent of other sports activities will half our risk for colon cancer and many other cancers. A diet rich in fruits and vegetables as well as fish and fish oils will reduce the amount of free radicals in our system cutting down on the circulating inflammatory substances. This prolongs life, prevents all of the major diseases of modern civilization and leads to longevity as the study of the Okinawa diet has shown.

Based on an article in the Time Magazine, March 22, 2004 edition, page 54 to 60.

Here is a chapter on arteriosclerosis from the Net Health Book, which explains inflammatory changes of the arterial wall:

http://nethealthbook.com/cardiovascular-disease/heart-disease/atherosclerosis-the-missing-link-between-strokes-and-heart-attacks/

Last edited October 26, 2014

Nov
01
2003

Leeches And Arthritis Pain; Old Facts And New Insights

Leeches have been used for centuries, particularly in Europe, for the treatment of chronic conditions and for arthritis pain. A group of researchers under Dr. Gustav J. Dobos from the University of Essen (Kliniken Essen-Mitte) in Germany published a paper in the Nov. 4, 2003 edition of the Annals of Internal Medicine (Ann Intern Med 2003;139:724-730,781-783) about the use of leeches in osteoarthritis, and particularly with knee arthritis.

In a randomized trial that lasted 91 days the researchers applied 4 to 6 leeches once to the knees of one group of 24 patients and used conventional diclofenac gel topical applications twice daily in a matched control group. On average the leeches fell off after 70 minutes. A simple pain score (Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) visual analog scale pain scores) was used to quantitate the pain that the patients experienced in both groups. I have tabulated the results after 7 days of therapy and included the relative improvement in the pain score here, based on their data.

Leeches And Arthritis Pain; Old Facts And New Insights

Leeches And Arthritis Pain; Old Facts And New Insights

According to Dr. Dobos there are powerful anti-inflammatories and hyaluronidase in the saliva of the leeches that have not been defined further. Now that these initial investigations have shown a more than 3-fold beneficial effect of the leeches versus conventional anti-inflammatory therapy for osteoarthritis, it is the intention of the group to define the active pharmaceutical ingredient from the leeches further.

Relief from osteoarthritis knee pain using leeches or diclofenac
Arthritis therapy: WOMAC
pain scores improved…
Relative improvement
of pain score:
leeches (applied
once)
from 19
to 52
64%
diclofenac gel
(twice per day for 28 days)
from 42
to 52
19%

Apart from pain control other beneficial effects such as improvements in ranges of motion, swelling and inflammation were also noted, again more so in the group treated with leeches. However, leeches have the disadvantage that they puncture the skin and that they can transmit infections (from Aeromonas hydrophila). It is hoped that in future medication can be developed from this line of work that can be taken in pill form without the dangers of applying leeches.

Here is a link to a review of osteoarthritis from the Net Health Book.

Last edited October 26, 2014

May
01
2003

Allergies, Asthma And Diabetes All Helped By Fish Oil

Cod liver oil was what your grandmother told you to take. It turns out she was right as two studies from Manchester/England and Boston/US have shown. The common denominator are omega-3-fatty acids, which are found in fish oil, cod liver oil, mackerel, salmon and other fish, generally speaking all sea food that feasts on plankton.

1. A prospective study with a cohort of 1100 children from before their birth until their 5th birthday, which will be next year, is being conducted in Manchester/England.

A smaller pilot study with 37 children (4-year-olds from this cohort) was recently analyzed as reported in Denver by Dr. Clare Murray, a pediatric lung specialist from the University of Manchester. The investigators have done detailed diet analyses with the help of the parents. They found that children with severe asthma were taking in a lot less omega-3-fatty acids than a healthy control group. Further analysis showed that the asthmatic group took in a lot of the inflammation provoking omega-6-fatty acids, whereas the control group had a much better balance between these two unsaturated fatty acids. Apparently it is the ratio between omega-6 to omega-3 fatty acids that determines whether the prostaglandin metabolism is switched versus pro-inflammatory (ratio more than 3 to 1) or versus anti-inflammatory (ratio 3 to1 or less). This article can be found in the Medical Post, Vol39, No.17 (page 19), April 29, 2003.

2. Another study is mentioned on the same page of the Medical Post: Dr. Frank Hu from the Harvard School of Public Health is the lead author of a study published in Circulation: Journal of the American Heart Association. 5103 female nurses with established type 2 diabetes have been followed for about 18 years and their medical histories, life styles and eating habits were updated every two years.

Allergies, Asthma And Diabetes All Helped By Fish Oil

Allergies, Asthma And Diabetes All Helped By Fish Oil

In the beginning of the study every patient was free of heart disease and cancer. The big surprise was that eating fish 5 times per week diminished the risk for developing heart disease by 65%. Even the women in the study who ate fish once or twice per week had 40% less heart disease than those who did not eat fish. In addition, fish eaters survived those who were not fish eaters much better (lower mortality). Controls of women without diabetes who ate fish five times per week had also a reduction of heart disease by 35% compared to non fish eating controls. Dr. Hu stated that it is the omega-3 fatty acids in fish that are the active ingredient. They are known to reduce irregular heart beats (arrhythmias) that can lead to sudden death. Omega-3 fatty acids also reduce blood fat levels (triglycerides), clot formation and improve blood vessel function. He also noted that both genders have the same benefit (no difference between male and female), just that the study was done on female nurses.

Comments: For your information the table below shows what foods contain omega-3 and omega-6 fatty acids.

Omega-3 and omega-6 fatty acids in our food
Type of unsaturated fatty acid: Foods that contain this type of unsaturated fatty acid:
omega-3 fatty acid flaxseed oil, walnuts, macadamia nuts, fishoil, canola oil, mackerel, salmon, sardines, tuna and most cold water fish
omega-6-fatty acid corn oil, cotton seed oil, grape seed oil, safflower oil, soybean oil and sunflower oil

In the past 50 years the food industry has changed the ratio of omega-6 to omega-3 fatty acids in many common foods to the point that the ratios are now 12 to 1 and up to 25 to 1. It is cheaper to produce these foods in that manner as they often have a longer shelve life. Read food labels. Inform yourself about omega-3 fatty acids. Take 2 capsules of a high strength, molecularly distilled (to remove PCB’s, mercury and other heavy metals) fish oil once per day and include more fish in your meals. Avoid deep fried foods, as they contain omega-6 fatty acids.

Here are some links explaining this more:

Link about balanced nutrition.

More details about fat and fatty acids.

Last edited October 26, 2014

Feb
01
2003

A Slipped Disc…Do Surgery

In the Dec.31, 2002 edition of the Medical Post a report of the recent North American Spine Society’s annual meeting in Montreal was entitled: “Aggressive approach to slipped discs needed”. A ground breaking study from England was presented that will change the attitude of many physicians about “slipped discs”.

Discs in the lower back do not really “slip”. The disc can bulge, protrude or herniate. In the center of the disc is a more liquid part (nucleus pulposus), which can leak out when the fibrotic shell of the disc tears.

This occurs commonly with aging and also with obesity. Dr. Keith Greenfield from the University of Bristol presented data together with the Walton Neurosurgery Centre in Liverpool showing that the borderline cases (“bulging discs”)that previously were treated without surgery do much better when early surgery is done (discectomy). This is a shift for many European countries and Commonwealth countries including Canada. In the US back surgeons always had a higher surgical rate as MRI scans have been used much earlier as the standard and the hidden minor disc protrusions and bulging discs are visualized earlier. Dr. Greenfield’s study involves 88 patients who belong into the group of patients who are borderline cases between those who definitely need surgery because of a sciatic nerve compression and those who do not need surgery (normal MRI scan). Clinically the “slipped disc” group (with disc bulges) has moderate back pain and some pain that radiates into the leg.

A Slipped Disc...Do Surgery

A Slipped Disc…Do Surgery

They have moderate disabilities with problems of walking, sitting, travelling and standing. The investigators treated half of the patients with microdiscectomy and the other half with conservative treatment (physiotherapy etc.). One year after the surgery a large percentage of them had returned to work and are feeling fine. The control group is quite the opposite: a large percentage of them has slipped into total disability that makes it impossible for them to return to work. Many have entered into chronic pain syndromes that might keep them disabled for a long time. The study is ongoing and the group will report about the two year follow-up point in Vancouver/B.C./Canada in May 2003 at a conference of the International Society for the Study of the Lumbar Spine. For now it seems that microdiscectomy is the treatment of choice in the bordrline cases of disc bulges and mild disc protrusions.

Comments: The rate of back surgery in the US has been 10 times that in England. Perhaps it is time that back surgery is being standardized and MRI scans are done routinely in every more significant back case to find out what’s going on earlier in the course of back pain. The direction medicine is going is that back pain that persists for more than 1 month likely should be MRI scanned. In case of a positive finding (bulge, protrusion or disc herniation), this study suggests that doing a microdiscectomy would be the new standard of therapy. Early mobilisation is the other key, which sports medicine physicians have been aware of and used for the last decade. If it’s good for athletes, it is likely good for the public at large.

Other link: Low back pain.

Last edited December 10, 2012

Jan
01
2003

Vertebroplasty And Kyphoplasty: Are These Procedures Safe?

These two orthopedic spinal reconstruction pocedures have become popular in the past few years. “Vertebroplasty” means doing a repair job on a damaged vertebral bone (spinal column bone). Originally this was developed for end stage cancer patients who had a single bone metastasis that led to a collapse of this vertebral bone. The difference in a good outcome of this procedure can mean the difference between being bedridden until death or walking and being active.

In a recent review of THE BACK LETTER (Vol.12, 12, Dec. 2002, Lippincott Williams & Wilkins), which critically reviews the literature regarding back pain and treatments, this procedure, even if successful, has not been researched long enough to be considered “standard therapy”. Many investigators report a success rate of 95% for compression fractures in patients with osteoporosis. But the FDA has warned that the bone cement that it used in this type of spinal surgery has never been properly investigaed for this application in non-cancer patients.

Nevertheless the technique of vertebroplasty has been clinically so impressive that those with severe kyphosis in the spine also wanted surgery. Kyphosis is a roundback in the mid spine area (thoracic spine) that can significantly interfere with normal posture, breathing action and cardiovascular functioning. Kyphoplasty is the procedure of repairing the curvature of the kyphosis, which consists usually of a series of several vertebral bodies with wedge shaped compression fractures in the thoracic spine. Often these patients are older and have osteoporosis.

Vertebroplasty And Kyphoplasty...Are These Procedures Safe...

Vertebroplasty And Kyphoplasty…Are These Procedures Safe…

THE BACK LETTER warns that the verdict on longterm follow-ups is not out. It may take a long time, even 10 to 15 years before this will become available as proper controlled studies have never been done. As the FDA link show, there can be serious life threatening complications from the procedure itself (spinal cord compression, respiratory arrest and death etc.). However, the longterm complications have not been reported properly as there is no longterm trial going on where the investigators would specifically concentrate on finding complications and untoward side-effects.

A well-designed multicenter trial regarding vertebroplasty and kyphoplasty is badly needed to answer these safety questions. Apparently efforts are on their way to attempt to do this.

Here is a link to my nethealthbook.com chapter on osteoporosis:

http://www.nethealthbook.com/articles/rheumatologicaldisease_osteoporosis.php

Last edited December 10, 2012

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