Adverse Drug Reaction

This article was written by Dr Ray Strand.

January, 2007 Vol. 4 No. 1
Death by Prescription
When I released my book, Death by Prescription [Thomas Nelson 2003], I alerted people to the fact that the 3rd leading cause of death in the US and Canada was legal medication. The medical literature has shown us that over 100,000 deaths annually are due to properly prescribed and properly administered medication. When you combine these numbers with the 80,000 deaths due to improperly prescribed or administered medication, you have a total of 180,000 deaths each and every year due to adverse drug reactions. This makes adverse drug reactions to LEGAL medication the third leading cause of death, following only heart disease (750,000 deaths) and cancer (580,000 deaths) and just ahead of strokes (140,000 deaths). I also revealed in this book that there are over 2,000,000 hospital admissions in the US alone each and every year that are directly related to adverse drug reactions. A recent study has shown that about 25% of the patients have an adverse drug reaction to outpatient medication. This means that you have a one in four chance of having some type of adverse drug reaction to any drug prescribed by your physician. The major reason that I wrote this book was because the medical literature has also shown us that over half of these adverse drug reactions could and should be avoided, if people just knew what to do. I would encourage you to take advantage of a special, limited-time offer to get a copy of my book, Death by Prescription, for just $7.95 [$6.95 each when you order 5 or more] through the bookstore located on my website at http://www.bionutrition.org/bookstore/.
There have been some recent revelations from the pharmaceutical industry and the medical community in regard to adverse drug reactions involving the use of non-steroidal anti-inflammatory drugs (NSAIDS), like Motrin and Naproxen, and what are now known as Cox-2 anti-inflammatory drugs, like Vioxx and Celebrex. This month’s Healthy for Life Newsletter will detail these amazing concerns about the world’s most widely used category of medications.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDS)
The October 4th, 2006 issue of the Journal of the American Medical Association (JAMA) devoted two major review articles and an editorial regarding the safety concerns with the use of these drugs used to treat inflammation and pain. Arthritis is the most common chronic degenerative disease that we deal with as physicians. I have never had any patient die because of their arthritis however, I have had hundreds of patients who have suffered serious complications and even death trying to treat their arthritis using these drugs. I share the well-known fact in my book that there are over 100,000 admissions and over 16,000 deaths due to the toxic gastrointestinal effects of these drugs (upper GI bleeding) that NSAIDS cause. If this is not enough reason for concern, a review article in the October 4th issue of the JAMA revealed that, this class of drugs also causes kidney damage to over 2.5 million individuals each and every year in the US alone.
When you consider that Motrin (Ibuprofen) and Aleve (Naproxen) are now available over-the-counter, it brings this situation full circle. Now it is not only a major cause of upper GI bleeding, but it is also one of the major causes of kidney damage.
When you take into consideration that these drugs are primarily used for the treatment of pain and the inflammation of arthritis, which is not a fatal disease, you quickly begin to realize that the

danger of developing arthritis is going to be the medications you consume for this disease.
COX-2 Anti-inflammatory Drugs Enter the Picture
The pharmaceutical industry and medical community have been aware of the inherent dangers of taking NSAIDS when it comes to their toxic effects to the lining of the stomach. Pharmaceutical companies have been trying to develop new and safer medication to replace these NSAIDS as the primary treatment of inflammation and pain. NSAIDS are known to non-selectively block the COX-2 enzymes, which is the primary cause of the inflammation of arthritis and gives the NSAIDS their therapeutic effect. The problem with NSAIDS is the fact that they also block COX-1 enzymes, which are critical for protecting the lining of the stomach. Generally, this is one of the main problems with pharmaceutical drugs. They block a natural enzyme system in order to produce a beneficial pharmaceutical effect. However, the body is an amazing and intricate creation. When a natural enzyme system is blocked in one part of the body, it can cause an adverse reaction by blocking another enzyme system in another part of the body that is not desirable. This was the problem with NSAIDS. So the pharmaceutical industry felt that the best way to improve these drugs was to create an entirely new class of drugs that would specifically block the COX-2 enzyme system and not affect the COX-1 system. This would gain the benefits of decreasing inflammation and pain, while at the same time, decrease the risk of upper GI bleeds. The introduction of Vioxx followed shortly by Celebrex in 1998 allowed us to enter the world of these COX-2 anti-inflammatory drugs.
Initially, the clinical trials did show that the risk of upper GI bleeds was about 50% of the risk experienced by NSAIDS. Due to the intense marketing of these drugs to the physician and consumer, these COX-2 drugs quickly became one of the most prescribed medications in the world. As I share in my book, Death by Prescription, when a drug is first approved as safe and effective by the FDA, the FDA only knows about half of the serious adverse drug reactions of the newly approved drug. They also have established a policy that states that they will not list a safety risk on a drug unless there is “complete certainty” that the drug causes the problem.
The entire drug approval process has shifted dramatically in favor of the pharmaceutical industry and away from the safety and protection of the consumer. This, in large part, is due to the fact that the pharmaceutical industry now finances over 50% of the FDA’s budget via the use of “user-fees.” A drug company is now required to pay the FDA over $300,000 each and every time they submit a new drug application to the FDA. That is correct. This popular program established by the US Congress in 1992, known as the Drug User-Fee Act, now provides over half of the financing to operate the FDA. So they are supposed to be monitoring the FDA for our protection the pharmaceutical industry.
Early Concerns about the safety of COX-2 Inhibitor Drugs
In the pre-clinical trials done involving Vioxx there was strong evidence that this drug increased the risk of blood clotting and heart attacks. However, because of the FDA’s practice of requiring “complete certainty” before acting on safety concerns, these drugs were still approved for use in the general population. Amazingly, the potential increased risk of having a heart attack was not even placed in the drug warning labels given to the doctors.
Within months of release of these drugs to the public, the Vioxx Gastrointestinal Outcomes Research (VIGOR) study did show a 50% reduction in serious upper GI bleeds. However, in this same study there was a five-fold increased risk of having a heart attack in those individuals who took Vioxx. This meant that for every upper GI bleed that was prevented, a patient suffered a heart attack instead. Merck tried to cover this

finding up by reporting that the control group, which was taking Naproxen, actually had 1/5 the risk of having a heart attack, instead of stating that there was a five-fold increased risk in taking Vioxx. They told the physicians and the medical community not to worry because it was not that Vioxx increased the risk of having a heart attack, but instead, that taking Naproxen had a cardioprotective affect much like aspirin. The FDA and the physicians bought this argument and Vioxx was allowed to remain on the market with no warning to the physicians or public that Vioxx may increase your risk of having a heart attack.
Then, in 2004, Merck withdrew Vioxx from the market after the Adenomatous Polyp Prevention Trial (APPROVE) showed a two-fold increase risk of developing a heart attack even on very low-dose Vioxx (25 mg daily). However, Merck claimed at the time that this risk did not occur until after the participants had been on Vioxx for at least 18 months. This move by Merck was an attempt to avoid numerous lawsuits following the withdrawal of their drug from the marketplace. The problem was the fact that Merck had performed their statistical reporting improperly and this statement by Merck was an outright lie. In 2006, two years later, Merck corrected this statement and admitted that they had reported these findings incorrectly. Their review of the same data showed that the increased risk of developing a heart attack happened early on with the use of Vioxx and possibly even with the first dose.
The real concern is the fact that entire class of COX-2 inhibitor drugs that are still on the market are showing similar risks in increasing the risk of having a heart attack when taking these drugs. Celebrex also increases the risk of a heart attack with doses greater than 200 mg, however, the risk for lower doses of Celebrex is not clear at this point. Several other NSAIDS and COX-2 selective drugs have also now been shown to increase the risk of a heart attack. These drugs are Voltaren, Mobic, Indomethacin, and Motrin. The only NSAID at the present time that does not seem to increase your risk of having a heart attack is Naproxen or Aleve.
Now Let’s Get this Straight…….
The development of the COX-2 anti-inflammatory drugs by the pharmaceutical industry was motivated by the fact that thousands of people were dying each and every year due to upper GI bleeding, due to an adverse drug reaction to the NSAIDS. It was very evident that early on during the pre-clinical trials with these drugs that they increased the risk of blood clotting and heart attacks. However, the FDA saw fit to go ahead and approve these drugs anyway because the FDA was not “ABSOLUTELY CERTAIN” that these serious adverse reactions were due to the COX-2 drugs. Shortly after the release of these drugs it was shown, in very well done clinical trials, that there actually was a five-fold increased risk in COX-2 users of having a heart attack. The FDA and the medical community then allowed Merck to deceive the public and claim that this was not due to their drug, but instead, it was the result of the protective effect of Naproxen. The evidence really showed that for every case of upper GI bleeding that was being avoided; an individual instead actually suffered a heart attack. Then Merck was again allowed to misrepresent the scientific data when it took Vioxx off the market, by stating incorrectly that the increased risk of having a heart attack only occurred in those individuals who had been taking the drug for at least 18 months. Merck finally corrected this statement 2 years later by stating that the increased risk of having a heart attack began early in the use of their drug.
How can this Happen?
There really is not a short answer to this question. This is just one example of drugs being released to the public that are dangerous. Just think of the thousands of people who have suffered and died because of these drugs. Safety has definitely taken a back seat to the profits of the pharmaceutical industry. The FDA has totally changed its attitude and instead of asking,

“Should this drug be approved?” they are asking “How can we get this drug approved?” The only way this can be accomplished is by overlooking possible safety hazards of the drugs they approve and then allowing pharmaceutical companies literally to lie and deceive the medical community and the public as the dangers of their drugs become evident.
I would strongly encourage each and every one of you to consider getting a copy of my book Death by Prescription and learn how you can better protect yourself, your family, and your loved ones from the third leading cause of death—legal medications. I detail the chain of events that can lead to a serious adverse drug reaction. When you consider the 100,000 hospital admissions and 16,000 deaths due to upper GI bleeds caused by NSAIDS, the new revelation that these drugs also cause damage to over 2.5 million NSAID users annually, and that all the COX-2 anti-inflammatory drugs dramatically increase your risk of having a heart attack, this book becomes a must- read. Especially since you can get this book now at this special, limited-time offer for just $7.95 (http://www.bionutrition.org/bookstore/).
Safety of Nutritional Supplements
Do you agree with me that it seems very hypocritical that the FDA is now very concerned about the safety of nutritional supplements taken at optimal or advanced levels? Especially when you consider that there have only been approximately 10 deaths reported with the use of nutritional supplements during the past decade. Almost all of these were due to the use of niacin prescribed by physicians at massive doses in attempt to lower cholesterol. This flies in the face of the fact that there are over 2 million hospital admissions and over 100,000 deaths due to properly prescribed and properly administered medications, which had been approved by the FDA. Nearly 25,000 to 30,000 deaths each and every year are now felt to be the result of these NSAIDS and COX-2 drugs.
Just contrast all of this with the use glucosamine sulfate along with tumeric or some other natural anti-inflammatory for the treatment of inflammation and pain. You have no side effects and these natural products have been shown in clinical trials to actually decrease inflammation safely and actually slow down the progression of arthritis and in some cases even rebuild your joint cartilage. NSAIDS and COX-2 drugs not only do not slow down the progression of joint deterioration, but have also been shown in some clinical studies to make the progression of the disease occur faster. Doesn’t make too much sense, does it? The only thing that could explain the FDA’s attack on the safety of natural products while blindly approving harmful drugs is because of their willing support of the pharmaceutical industry and their greed.
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Reversal of Metabolic Syndrome

This change my life when I found out why I wasn't loosing weight!!

No. 14 USANA Health Sciences July 20, 2005

Reversal of Metabolic Syndrome through a

Lifestyle Change Program involving a

Low Glycemic Diet and Exercise

Dr. Ray Strand, Dr. Tim Wood and Toni McKinnon RN, CCRP

USANA Health Sciences, Inc. Salt Lake City, UT, USA

Introduction

Type 2 diabetes has risen to epidemic proportions in the United States and other industrialized countries (1,2). Recent research has shown that this disease is highly preventable, and that lifestyle interventions involving changes in diet and physical activity are effective in reversing many of the risk factors and disease processes associated with this condition (3,4,5). Such approaches are thought to be particularly effective in people with Metabolic Syndrome, a pre-diabetic state involving multiple symptoms including overweight and central obesity, insulin resistance, elevated blood lipids, elevated blood glucose, and high blood pressure (6).

The objective of this clinical trial was to determine whether a 12-week lifestyle modification program, involving low-glycemic functional foods, a low glycemic diet, and modest exercise could reverse many of the symptoms of Metabolic Syndrome in affected people.

Methods

Twenty-five subjects, five males and 20 females, 20-65 years of age, were recruited for the study.

To select people at risk for Metabolic Syndrome,

men were required to have a waist measurement

>40 inches and women had to have a waist

measurement >34.5 inches. Moreover, all had to

have two or more of the following additional

symptoms of Metabolic Syndrome: elevated

blood pressure (>130/85 mm Hg), elevated

triglycerides (>150 mg/dl), elevated fasting

glucose (>110 mg/dL), low HDL cholesterol (<50 style=""> The lifestyle change program employed in this study was developed by Dr. Ray Strand, a family practice physician in Rapid City, SD. This 12-week, internet-based program was specifically designed to help people reverse insulin resistance through dietary modification and increased exercise. Specifically, during Weeks 1-4 of the program, subjects were instructed to consume one low-glycemic meal replacement shake for breakfast, a second shake for lunch, one low-glycemic nutrition bar as a daily snack, and a normal, but low-glycemic dinner prepared according to instructions provided by Dr. Strand. During Weeks 5-12 of the program, subjects consumed one lowglycemic meal replacement shake per day, one snack bar, and two normal, but low-glycemic meals. In addition, throughout the 12 weeks, subjects took a multivitamin-mineral supplement daily. All meal replacement shakes, snack bars, and nutritional supplements were provided by USANA Health Sciences, Inc., Salt Lake City, UT (7). Subjects were further coached to increase their physical activity and to ultimately exercise at least 45 min per day, five days per week, during the last eight weeks of the program.

To determine the impact of the lifestyle program on the subjects’ health, measurements of the following parameters were made during Baseline (Week 0), Interim (Week 6), and Final (Week 12) Visits to the study clinic: weight (lbs), height (in), waist circumference (in), blood pressure (mm Hg), blood cholesterol (total, LDL, HDL; mg/dL), serum triglycerides (mg/dL), plasma glucose (mg/dL), and insulin sensitivity (8).

Results

Twenty-one of the 25 study participants showed good (>80%) compliance with the dietary and exercise recommendations of the program. Four showed relatively poor compliance. Nevertheless, we included data from all subjects in the statistical analyses of results. The attached figures show the changes in average weight, total cholesterol, serum triglycerides, systolic blood pressure, insulin sensitivity, and urinary 8-isoprostanes (a marker of oxidative stress) for the 25 participants. In addition, the following results were observed. The average BMI of participants declined from 34 ± 5 (Baseline) to 32 ± 5 (final). Waist circumference declined from 41.5 ± 4.2 in (Baseline) to 38.9 ± 4.4 in (Final). Diastolic blood pressure declined from 86 ± 7 mm Hg (Baseline) to 80 ± 7 mm Hg (Final). LDL cholesterol dropped from 134 ± 23 mg/dL (Baseline) to 111 ± 24 mg/dL (Final), while HDL cholesterol remained unchanged at 43 ± 10 mg/dL throughout the study.

Discussion

On average, the 12 week lifestyle modification program employed in this study had dramatic impacts on the health of the 25 subjects. On average, subjects lost 13 lbs of body weight per person over the 12 weeks (about 6% initial body weight). Four subjects lost 25 lbs or more. This weight loss was further reflected in significant declines in BMI and waist circumference. Even more dramatic, however, were the changes in cardiovascular and metabolic health. Blood pressure, for example, declined from an average of 131/86 mm Hg (Baseline) to 121/80 mm Hg (Final). Total cholesterol dropped from an average of 206 mg/dL (Baseline) to 176 mg/dL (Final). Most of this decline resulted from a drop in LDL cholesterol from an average of 134 mg/dL (Baseline) to 111 mg/dL (Final). Fasting blood glucose levels declined slightly over the 12 week program from an average of 97 mg/dL (Baseline) to 95 mg/dL (Final). And a standard Index of Insulin Sensitivity based on a Glucose Tolerance Test increased markedly from an average of 0.071 (Baseline) to a value of 0.087 (Final).

All of these changes are consistent with a

reversal of Metabolic Syndrome and with

significant improvements in cardiovascular and

metabolic health. They are further consistent

with a dramatic reduction in the risk of type 2

diabetes. Moreover, it is important to note that,

most of the changes in the health parameters

measured in this study were continuous through

the 12 week period, suggesting that as the

lifestyle program is extended, further

improvements in health status and reductions in disease risk can be expected.

We conclude that the lifestyle change program employed in this study was fully effective. The shifts in dietary habits to include low-glycemic functional foods and low-glycemic meals, and the modest increases in physical activity offer a valuable approach for reversing Metabolic Syndrome and preventing Type 2 diabetes and heart disease in at-risk people.

Acknowledgment: This study was funded by USANA Health Sciences, Inc. It was conducted in partnership between USANA and Dr. Ray Strand. The protocol for the study was approved by the Western Institutional Review Board.

References

(1) Mokdad AH, et al. 2000. Diabetes trends in the U.S.: 1990-1998. Diabetes Care 23:1278.

(2) Narayan KM, et al. 2003. Lifetime risk for diabetes mellitus in the United States. JAMA 290:1884..

(3) Diabetes Prevention Program Research Group.

2002. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin.

N Engl J Med 346:393.

(4) Tuomilehto J, et al. 2001. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N

Engl J Med 344:1343.

(5) Pan XR, et al. 1997. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. Diabetes Care 20:537.

(6) Reaven G. 2000. Syndrome X. Simon and

Shuster, NY. 284 pp.

(7) The functional foods supplied by USANA Health Sciences included low-glycemic drinks (e.g. Nutrimeal) and low-glycemic bars (Nutribars). The multivitamin/mineral

supplement was USANA’s Essentials (Mega

Antioxidant plus Chelated Mineral).

(8) Stumvoll M, et al. 2000. Use of the oral glucose tolerance test to assess insulin release and insulin sensitivity. Diabetes Care 23:295.

Results from the clinical trial measuring Reversal of Metabolic Syndrome through a

Lifestyle Change Program involving a Low Glycemic Diet and Exercise. Results for the changes in body

weight, total cholesterol, serum triglycerides, systolic blood pressure, insulin sensitivity, and urinary 8-

isoprostanes are shown in the six graphs below. In all cases, the changes from Baseline to Week 12 are

statistically significant at the p<>

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