June Russell's Health Facts

Caveats of Studies and Drugs:

How Studies Can Be Deceiving and How Results May Be Misinterpreted

[Conflicts of Interest]   [Drug Reactions]   [Bad Science]   [Questionable Studies]   [Pain Killers and NSAIDS]   [Treatment of Fever]   [Vaccinations]   [Depression]   [Surgery]  

Conflicts of Interest in Medical Studies

Dr. Marcia Angell says that money is at the root of drug abuses, and increasingly family doctors are doing the experimental drug testing from $50,000 to $250,000 per study. Standards are lowered so individuals will qualify for the trials, and not all the 'volunteers' know what they are volunteering for, or the risks involved.
{"Drug trial dangers?" CBS News/60 minutes, Apr. 5, 2001}

Medical studies are commonly sponsored by private industries such as drug companies, but many medical schools and their industry sponsors were not adequately safeguarded, which leaves the sponsors free to influence the studies. This means that valuable information, including negative results that could potentially harm the sponsor of a particular drug, may never be reported.
{The New England Journal of Medicine, Oct. 2002}

Two years ago USA Today exposed the corruption in the system that is used to approve drugs. More than half of the experts hired to advise the government on the safety and effectiveness of medicine have financial relationships with the pharmaceutical companies that will be helped or hurt by their decisions. Two years ago, NEMJ posted an article that said most of the media coverage of the drugs was corrupted by highly conflicted drug company interests.
{"Corporate control in medical research," mercola.com, Nov. 2002}

Since the 'Controlled Clinical Trials (CCT)' are very expensive — it costs about $200 million today to get a new drug on the market — the clinical trial is really an instrument for limiting competition in medicine, and for raising the costs of medicine to the public. According to Harris Coulter, PhD, the CCT has become popular for political reasons; it can be used to put alternative medicine in a bad light, because by comparison, clinical trials have not been performed. According to Dr. Judith Jones, Director of the Division of Drug Experience at the FDA, if the data is unsatisfactory toward the drug being tested, trials can be continued elsewhere until satisfactory results and testimonials are achieved. Unfavorable results are very rarely published and clinicians are pressured into keeping quiet about such data. The incentive to fabricate data is enormous — as much as $1,000 per subject is paid, which enables some doctors to earn up to a $1 million a year from drug research. Loss of future work is inevitable when the desired data is not produced.
{Reviews: "The controlled clinical trial: an analysis, campaign against fraudulent medical research, alkalizeforhealth.net, Jan, 2002}

You should read all "scientific" nutrition reports with extreme skepticism, and look who’s picking up the tab. Lycopene, one of the main ingredients in tomatoes, can help protect against prostate cancer, according to a study by the University of Illinois. The suggestion was to make sure there was a bottle of ketchup on the table at every meal. This study was partially funded by the company that makes Hunt’s tomato sauce and ketchup. No matter that ketchup is a ‘junk’ food.
{"Seeing red about ketchup,’ Daily Dose, WC Douglass’ e-mail, Jan. 2003}

Drug Reactions and Inappropriate Use of Drugs —
FDA Approval Doesn't Mean Safe

You are ten times more likely to be hospitalized from the use of a prescription drug than by an automobile accident. Drugs by their very nature are like a two-edged sword, for example; the same chemical that gives pain relief also disables part of the system that protects from stomach acid. If you don't need drugs, don't take them. Forty-three percent of the approved drugs cause cancer at a human dose.
{"Prescription for disaster," Tom Moore, author, on People's Pharmacy, public radio, Mar. 7, 1998}

Less than 5% of all reactions to drugs are reported to the FDA and drug companies, The side effects can be gradual: it took five years to find out the side effects from Seldane.
{Joe Graedon, "Ophra," Spring 1994}

Industry creates new diseases to sell new drugs. Economics has replaced curiosity as the driving force behind research, and sales reps are in the doctor's offices every day, pitching their products.
{The Daily Progress newspaper, Charlottesville, Virginia, 'Commentary,' Jul. 30, 2000}  Author's comments: In using drugs are we swapping one problem for another? Are the drugs either not effective or can they do more harm than good, harm that might not show up until later. It has been suggested than the harm may be so subtle as to not be noticed until months or years later when no one connects them to the previous use or continued use of drugs. Often a doctor will tell you that a particular problem couldn't be from a drug you are taking, when they just don't know. We are told by physicians that all drugs have side effects, and they don't always know how our individual bodies will react. The use of drugs can take over the functions of the body with the result that the body is then unable to resume control.

We found that nearly seven million Americans over the age of 65 are receiving one of a list of 33 potentially inappropriate drugs. Of these, nearly one million were elderly Americans who should always avoid these drugs.
{Dr. Arlene Beerman, Senior Research Physician at the Agency for Health Care Research and Quality, and co-author of an article in this week's Journal of the American Medical Association (JAMA) concerning a study of drugs in older Americans, People's Pharmacy, Dec. 15, 2001}

In 1999, the report by the Institute of Medicine said that medical mistakes in hospitals kill up to 98,000 hospitalized Americans a year, yet Dr. Rodney Hayward led a new study in 2001 that said it was closer to between 5,000 to 15,000 deaths due to errors in the original study. However, in this study researchers found widely varying opinions among the doctors on whether an error directly led to death, and even on what constituted an error, said Hayward, Professor of Medicine and Public Health at the University of Michigan. Dr. Lucian Leape of the Harvard School of Public Health, co-author of the Institute of Medicine report, defended his findings and said Hayward's conclusion was too small of a sample and manipulated statistics.
{"Study: medical errors overstated," AP, The Daily Progress, Charlottesville, Virginia newspaper, Wednesday, Jul. 25, 2001}

Drug companies spent 2.5 billion dollars last year to convince you to take their drugs. They have been able to change the rules and now the drug companies can market to consumers directly. Two-thirds of doctor visits resulted in a drug being prescribed. The physicians often rely on drugs as band-aids, and do not seek the cause of the problem. When allopathic physicians use pain killers, fever suppressants, steroids and other drugs, which are poisons, they have the effect of weakening the patient to the point of inhibiting elimination. The waste products and the toxins themselves may be reabsorbed, irritating the already overworked liver, the detoxification center of the body. There has never been a recorded death among the thousands of children treated for chicken pox hygienically, and without drugs. It is the allopathic medical treatments that are used to treat the symptoms that cause the complications which result in death. Aspirin, Tylenol, etc., also burden the liver and kidneys and throw the chemistry of the liver off.
{"Chicken pox: why do children die?" on mercola.com, Dec. 2001}

The Breast Cancer Prevention Trial (instituted by the National Cancer Institute), using more than 13,000, cancer-free high-risk women, found that women taking tamoxifen were four times more likely to develop endometrial cancer than those taking a placebo. Tamoxifen is also associated with a slight increase in the risk of blood clots, which can lead to deep venous thrombosis (DVT, or blood clots in the leg veins), or pulmonary embolism (blood clots in the lungs). Less serious side effects were similar to the symptoms of menopause.
{"Should you be taking tamoxifen?" The Johns Hopkins Medical Letter, Health After 50, June 2001}

Should men be leery of testosterone therapy? An estimated 250,000 American men now use testosterone therapy drugs. But the FDA never approved the drugs for use by otherwise healthy aging men, and they haven’t been tested on that population in any large clinical trial. There are risks, the least of which is temporary testicular shrinkage. The drugs can spur the growth of existing cancer cells in the prostate and may increase the risk of blood clots. The drugs also lower sperm count.
{"A loving feeling," Health, Newsweek magazine, Nov. 11, 2002}

Women suffering from heart failure who are taking the widely prescribed drug digoxin are slightly more likely to die than women who do not take the drug, a new study has found.
{"Study raises questions about digoxin," Hartford Courant, in The Daily Progress newspaper, Charlottesville, Virginia, Nov. 10, 2002}

Birth control pills deplete a woman’s body of vitamins C, B-12, B-6, B-2, folic acid and magnesium. The deficiency of folic acid can increase the risk of neural tube defects in pregnancy. HRT (hormone replacement therapy) depletes magnesium, vitamin B-6 and zinc.
{"Drug-Induced Nutrient Depletion Handbook," in Healthy Immunity newsletter, Mar. 2002}

Bad Science and Bogus Studies —
Anti-Oxidants and Vitamins

This study reported in the Journal of the American Medical Association 2002, involved 423 postmenopausal females patients who took 800 IU's of vitamin E, 1,000 mg of vitamin C, or estrogen pills. The mortality was 6.1% of the vitamin group, 6.1% of the hormone users and 4.3% of the placebo group — a difference in hard numbers of only 1.4% between groups. Scientific studies use relative numbers, which give the appearance of significance. Other caveats: thickening of the coronary arteries does not always equate with increased risk for disease {Circulation 2002}, and the severity of artery narrowing is a poor predictor of a subsequent heart attack.
{American Journal of Cardiology 1992}

Howard H. Wayne, MD, of the Noninvasive Heart Center of San Diego, writes that "increasingly it is becoming apparent that the amount of narrowing of the coronary arteries is of only minor importance. Such narrowing does not correlate with the patient’s symptoms, the performance of the heart or the patient’s prognosis." There is no mention that the postmenopausal females were prescribed folic acid supplements to reduce homocysteine levels, that postmenopausal females have a different type of coronary disease than men, nor that six of the ten patients were taking statin cholesterol-lowering drugs which deplete the body of coenzyme Q10, and essential antioxidant, particularly in cardiac tissues. This was not factored into the study. The bottom line is that it cannot be stated with certainty that high-dose antioxidant vitamin supplements increase the rate of mortality, or plaque buildup on artery walls.
{Bill Sardi, Health Journalist, askbillsardi.com, Nov. 2002}

You would think green tea is a miracle drug from all the publicity, especially since the latest study from Japan indicates that people who drink at least one cup of green tea daily get fewer heart attacks. Published in the Nov. 15, 2002 edition of the American Journal of Cardiology, there was a study of almost 400 patients who were scheduled for coronary angiography — not representative of the average population of Japan. They showed no effect from the intake of tea on arterial blockages, but there were fewer heart attacks in the patients who drank one or more cups of green tea a day. However, since the tea drinkers ate significantly more fruit and had higher HDL-cholesterol levels, green tea drinking may simply correlate with healthier diet and other habits.
{"Green tea and your heart," Nutrition News Focus, E-mail, Feb. 2003}

More Questionable Studies

A study by researchers from the University of Wisconsin and the University of Alabama reported that cutting calories might keep the heart young. One group of mice was allowed to eat almost as much as they could, while those in the second group had their caloric intake reduced by 26%. The researchers found that the group fed the lower calorie diet had a 19% reduction in age-related genetic changes; less DNA damage, a stronger immune system, and a suppression of programmed cell death (apoptosis). The details of the diet would be a crucial factor to determine what contributed to the results. The mice that were fed the restricted diet were fed a SPECIAL AIN-M semi-purified mouse food that was enriched with "proteins, vitamins, and minerals to avoid malnutrition." If the mice were not fed the same nutrients, how can one group be compared to another? Perhaps the positive effects came from the supplements more than the lower caloric diet.
{Health Sciences Institute e-alert, Nov. 7, 2002}

In the American Journal of Epidemiology there was a study of age-related cataracts and thickening of the arteries showing that both may arise due to oxidative damage caused by free radicals. Also the women with diabetes who had a cataract extraction were almost three times as likely to develop heart disease than women who were not diabetic. Caveats: all these women were health-care professionals who had better than average access to medical care, so there might have been a higher rate of cataracts than cataract extractions, and some of the cases of diabetes may have been undiagnosed.
{"Cataracts may indicate an increased risk of heart disease," Washington Post Health, June 5, 2001}

The notion that cancer patients could improve their outcomes through a sunny outlook gained momentum from a 1989 study that suggested women with advanced breast tumors lived longer if they attended support groups, but this study has never been replicated. The British Medical Journal reviewed 26 studies and found no solid evidence that this was true, even though a positive outlook can improve a patient’s quality of life.
{"Sunny outlook won’t add days with cancer," healthscout.com, Nov. 2002}

Pain Killers — Aspirin and Non-steroidal Anti-inflammatories

Taking ibuprofen before taking aspirin reduced the protective benefit of aspirin. Many are taking low doses of aspirin for their heart and take anti-inflammatory drugs like ibuprofen to relieve their arthritis pain or their tennis elbow. This interaction is less likely if aspirin is taken several hours before ibuprofen. Aspirin and acetaminophen are generally regarded as safe. However, in reviewing the habits of 1,000 healthy Swedes, a study showed that of those who took aspirin or acetaminophen regularly at least twice a week for at least two months prior to their diagnosis, those who used acetaminophen were more than twice as likely to have kidney disease as the nonusers.
{People's Pharmacy, Public Radio, Dec. 22, 2001}

Johnson and Johnson representatives state that the incident of overdose of acetaminophen is ‘rare’ and there are only a handful of cases every year. However, an FDA review reports that in the U.S., there are more than 14,000 unintentional overdoses of acetaminophen each year, with about 100 of those cases resulting in death. Can you imagine a natural supplement manufacturer trying to get away with dismissing 100 deaths per year as a "handful"? By some estimates more than 100 million Americans take acetaminophen and it can be found in almost 200 products other than Tylenol.
{Health Sciences Institute e-Alert, Nov. 2002}

According to a study in the Archives of Internal Medicine, Tylenol and ibuprofen drugs may boost hypertension in young and middle-aged women who do not have high blood pressure (those who took aspirin were at no higher risk). NSAIDS and acetaminophen may interfere with the ability of the blood vessels to remain dilated (if blood vessels constrict, then the blood pressure can go up). NSAIDS can cause the body to retain sodium which can raise blood pressure. Researchers have previously linked NSAIDS to high blood pressure, but only in people who already suffered from hypertension. However, the medical director of the Cardiopulmonary Research Science and Technology Institute in Dallas, Dr. Eric Eichhorn, said that there are a whole lot of other factors that could be responsible for this effect in young women.
{"Painkillers linked to high blood pressure," healthscout.com - Nov. 2002}  Author’s comment: This last comment shows the necessity of examining the original study before concluding that a study is valid — ‘there could be a whole lot of other factors.’

The over-the-counter anti-inflammatory pain medications may not just kill pain — they may kill you. More than 16,500 people die each year and 103,000 are hospitalized for serious complications caused by pain relievers known as non-steroidal anti-inflammatory drugs (NSAIDS), says the National Consumers League (NCL). An estimated 30 million Americans use NSAIDS and in one survey 64% of the respondents were unconcerned about serious side effects caused by them (30% say they don’t usually read the instructions on the label).
{"The pitfalls of over-the-counter painkillers," healthscout.com, Nov. 2002}

British researchers say that if taken by everyone who needs it, aspirin could save tens of thousands of lives, but now a panel of U.S. experts say that everyone at risk for heart disease should ask their physician about taking this common but powerful drug. Aspirin can cause serious bleeding in the gut and brain. The risk of this is small, but may be much greater than the risk of heart disease in relatively healthy people. The number of individuals for whom aspirin is a good deal is rather modest. You have got to have a substantial risk of heart disease before it makes any sense, says Al Berg, MD, the U.S. Preventive Services Task Force (USPSTF) chief, in the Jan. 14 issue of the Annals of Internal Medicine. Even if you are at high risk for heart problems, there is a lot one can do to reduce it — diet and exercise. Do aspirin's benefits outweigh the risks? Aspirin isn't a magic shield against heart attack. Diabetes increases a person's risk of heart disease, but also increases a person's bleeding risk from aspirin. Dr. Berg says that better diabetes management would do a lot more than aspirin to reduce a person's heart-attack risk.
{"Too few take daily aspirin, but for some, it could do more harm than good," webmd.com, Jan. 2002}

The 'rebound headache' affects many with chronic headache who regularly take medicine for acute pain, and may result in headache symptoms growing worse rather than better over time. Almost any pain reliever, prescription or nonprescription, can be associated with rebound headaches. Also daily intake of caffeine can put a patient at risk for rebound. Physicians with the best of intentions may prescribe larger quantities of medication at more frequent intervals for their headache patients because it is easy to miss a diagnosis of headache rebound. It is important to limit use of off-the-shelf prescription medications to two or three days a week.
{"Rebound headaches: when medication backfires," Alan M. Rapoport, MD, Healthology.com, Dec. 2001}

Aspirin may help ward off heart attacks if you already have heart problems. But for other people, the popular regimen may do more harm than good. Since chronic aspirin use can lead to internal bleeding and hemorrhagic stroke, experts say that people with no history of heart disease should not be using it as prevention. Exercising, quitting smoking and lowering blood pressure and cholesterol are surer ways to keep your heart going strong.
{Prevention: Second Thoughts, Newsweek, Aug, 14, 2000}

Treatment of Fever

Suppression of fever will limit the body's ability to fight the infection, and generally it is unwise to use Tylenol, aspirin or ibuprofen to control most fevers.
{"Acetaminophen (Tylenol) deaths reported," Townsend Letter for Doctors and Patients, May 1998}

Aspirin should not be used to treat fever in children under 16 years of age because of a deadly disease known as Reye's Syndrome (a syndrome of rapidly worsening neurological symptoms and liver degeneration in children with viral illness and chicken pox). Alcohol rub is a bad idea, just sponge with tepid water, as it is the evaporation of the water from the skin that removes heat and lowers temperature. Fever is not a disease - it is only one symptom of an illness, and likely not dangerous.
{"My baby's got a fever!" Herschel Lessin, MD, Healthology.com, Dec. 2001}

Suppression of fever with Tylenol, aspirin, or ibuprofen can limit the body's ability to fight infection, and can even be lethal. The Journal of Pediatrics, Jan. 1998, warned that at least 24 children in the U.S. have died and three have received liver transplants after receiving accidental overdoses of acetaminophen - the most widely used medication for relief of pain and fever in children and infants. Of the two dozen deaths, six were due to doses only slightly above the weight-based recommendations.
{"Acetaminophen (Tylenol) deaths reported," Townsend Letter for Doctors and Patients, May 1998}

Vaccinations

According to Hugh Fudenberg, MD, the world’s leading immunogeneticist and 13th most quoted biologist of our times (nearly 850 papers in peer reviewed journals); if an individual has had five consecutive flu shots between 1970 and 1980 (the years studied), his/her chance of getting Alzheimer’s Disease is ten times higher than if he/she had one, two or no shots. Dr. Fudenberg said it was due to mercury and aluminum that is in every flu shot, and most childhood shots. The gradual mercury and aluminum buildup in the brain causes cognitive dysfunction.
{ithyroid.com, 2002}

Another report states that the flu vaccine cuts stroke risk in half, and even more in people who have been vaccinated for five consecutive years.
{"Bottom Line/Health, Oct. 2002}

Taking vitamins may weaken flu shot's effect in the elderly, says a team of military doctors at the Wright-Patterson Air Force Base Medical Center near Dayton, Ohio. This may explain why flu vaccines are generally less effective in older adults compared with younger people. However, previous research has shown that nutritional supplements (those that contained trace elements} might improve the effectiveness of flu shots. The multivitamin used in this study contained no trace minerals such as zinc.
{The journal of Infectious Diseases in Clinical Practice, Reuters Health, HealthCentral.com, Jul. 2001}

French researchers in Stroke: Journal of the American Heart Association (Feb. 2002), reported that flu vaccine might offer significant protection against stroke, especially for people age 75 or younger (of 270 people studied, aged 60 or older). The authors of the study questioned whether this association was due to the vaccination or the possibility that people who received the vaccine lived healthier lifestyles and less likely to have a stroke in the first place. This could only be determined in a prospective randomized trial. Each year, about 600,000 people suffer a new or recurrent stroke, according to the American Stroke Association. Stroke can affect people’s neurological functions, including speech, vision and coordination.
{Bottom Line Health newsletter, Oct. 2002}  Author’s comment: There was no mention of alcohol use affecting the outcome. Although light to moderate alcohol consumption has been shown as possibly lowering ischemic stroke, even light drinking dramatically increases the chance of hemorrhagic stroke. Ischemic stroke is more common, but hemorrhagic strokes are more serious and cause more severe damage. A safer choice is to include lots of heart-healthy vegetables and fruits, without the risks of alcohol.
For additional information see Alcohol - Heart on this Web site.

Researchers report that in animal studies, a vaccine that clears the brain of toxic deposits (beta amyloid) also tends to double the risk of stroke. Although some earlier studies found that a vaccine was able to stop the progression of Alzheimer’s, researchers are uncertain if beta amyloid is the cause of Alzheimer’s disease.
{"Researchers: vaccine may cause strokes," Washington, ‘In the Nation,’ The Daily Progress, a Charlottesville, Virginia newspaper, Nov. 15, 2002}

Depression

Moderate physical activity cuts women's risk of mental decline, say researchers at the University of California, San Francisco in a study that showed for every mile women walked (per week) they reduced their risk of lower cognitive decline. Caveats: activity levels were self-reported, and most of the women were white. The results may have been skewed because this study eliminated disabled and demented women, and the women who dropped out of the study tended to be older and less healthy.
{Jul. 23, 2001 edition of Archives of Internal Medicine, in the Washington Post Health, Jul. 31, 2001}

A severely depressed person who works out three times a week will get the same effect as taking Zoloft regularly.
{Health magazine, Nov. 2002}

The trend toward antidepressants as the treatment of choice is viewed with concern by some mental-health experts. There is a tremendous amount of advertising by the drug companies, and doctors are immediately reaching for the prescription pad. Drugs certainly have a part, but we need to look at what is making people depressed, and address it in a comprehensive, holistic and individualized way, says Dr. James Gordon, a psychiatrist who directs the Center for Mind-Body Medicine in Washington, D.C. Major depression accounts for 20 to 30% of all suicides and affects more than 19 million Americans at any point in time.
{JAMA, healthscout.com, Nov. 2002}

Caveats of Surgery

Even though decline in mental function is often temporary after bypass surgery, five years after surgery, 42% had experienced a decline in intellectual abilities.
{New England Journal of Medicine, 2001}

If you must have breast cancer surgery, the timing of your operation may be a matter of life or death. The phase of the menstrual cycle at the time of the operation is very important for the long-time survival of women with breast cancer. At the ten-year mark, those who had the surgery between 0 to 2 days or 13 to 32 days after their last menstrual period had a recurrence-free survival rate of 84% as opposed to a 54% survival rate for those who had surgery between 3 to 12 days after their last menstrual period.
{Lancet 1991, in Health Immunity newsletter, Mar. 2002}

A report in Obstetrics & Gynecology (2000) says episiotomies have no scientific foundation (assumed benefits have not been confirmed by studies) and they should no longer be performed routinely. An episiotomy is the cutting of the tissue between the vagina and the anus in women in stage two of delivery.
{www.garynull.com, Sep. 2002}

--- Questions About Bypass Surgery ---

Major government studies have shown that for most medically stable heart patients, bypass surgery does not prolong life or prevent future heart attacks, says Dr. George J. Juetersonke in his book, "Passing on Bypass Using External Counterpulsation: An FDA Cleared Alternative to Treat Heart Disease Without Surgery, Drugs or Angioplasty." He adds, "And in spite of its widespread use, angioplasty has yet to be shown effective in preventing heart attacks. In fact, the procedure may actually lead to more heart attacks."
{mercola.com - Dec. 2001}

Bypass surgery is unproven and ineffective. The first coronary artery bypass surgery was performed in 1967, but the procedure was not evaluated by the scientific community until a decade late when it was already being done on tens of thousands of patients each year. The first study, in which 596 patients with heart disease were assigned bypass surgery or drug therapy, found that surgery conferred no benefit at all. After three years, the rates of heart attack and death were virtually the same for both groups. Normally, such a poor showing would have landed bypass in the rubbish bin of failed therapies. But as Eugene Braunwald, MD, Chief of Cardiology at Harvard Medical School, stated in the New England journal of medicine 25 years ago, "an industry is being built around this operation . . . it is developing a momentum and constituency of its own, and as time passes it will be progressively more difficult and costly to curtail it . . ." Six years later, a second study was published with the same results, providing even more conclusive evidence that bypass surgery just doesn't work. At least a dozen subsequent studies have proven that the basic presumption of bypass surgery is just plain wrong. If you are scared into bypass surgery, you'll believe that you're alive because of the surgery, when in reality, your chances of survival would have been the same without the surgery. The vast majority of heart attacks are caused not by the large plaques picked up on angiography but by far smaller, yet more deadly lesions.
{'Health & Healing newsletter, Dr. Julian Whitaker, Feb. 2002}