THE VIAGRA MIRACLE

Oral sildenafil in the treatment of erectile dysfunction by Irwin Goldstein in the May 14, 1998 issue of the New England Journal of Medicine reported on an effective, reliable, simple to use, relatively safe, noninvasive, discreetly-administered drug to treat erectile dysfunction (impotence) (338:1397). Part one of the study was a 24-week trial of 532 men who took placebo or various doses of Viagra (sildenafil)--25 mg, 50 mg, or 100 mg. The greater the dose the better the results. After 24 weeks of treatment, improved erections were reported by 56%, 77%, and 84% of men taking increasing doses of Viagra compared to 25 percent with the placebo.

The second part of the study was a 12-week trial in which 329 men could increase their dose of Viagra or placebo on their own initiative. Of the men taking Viagra, 101 of the 136 reported improved erections compared to 23 of the 118 in the placebo group. This resulted in quadrupling the success of sexual intercourse. Benefits were seen in men diagnosed with many different sources of erectile dysfunction, including those classified as organic, like atherosclerosis, diabetes, hypertension, and history of radical prostatectomy, and those classified psychogenic, due to mental problems.

The most frequent side effect was headache, followed by flushing, dyspepsia (indigestion), and visual disturbances. No man had priapism (persistent erection not due to sexual arousal, accompanied by pain and tenderness).

The study was funded by Pfizer, the manufacturer.

COMMENT: (From a man’s perspective, of course).

Impotence is defined as the consistent inability to achieve or sustain an erection of sufficient rigidity for sexual intercourse. This excludes problems of libido, ejaculation, orgasm, and fertility. It is estimated that 10 million American men are impotent. It is age-dependent with about 2 percent at age 40 and 25 percent at 65 years of age. With disease, the numbers are higher; for example, 35 to 50 percent of diabetics are impotent. The most common cause of impotence is occulusion of the arteries to the penis, and arteries to the nerves that supply the penis, with atherosclerosis. Medications such as antacids (Tagamet), antidepressant and antipsychotic drugs also cause impotence; however, blood pressure pills are the most common offenders.

Before looking to Viagra for help (at $8 to $10 a pill) consider other things you might do to improve your performance. Begin by becoming healthy with diet and exercise. This will benefit you in several ways: your circulation will improve, you’ll get off medications that make you impotent, and you’ll look better to yourself and others. Improve communication and relations with your sexual partner. Yohimbine (Yocon) is an herb made from the bark of a tree growing in East Africa. It is so effective that drug companies have packaged it into pills that your doctor can prescribe. It is taken three time a day and effects are usually seen in 2 to 3 weeks.

If you do take Viagra, a healthy diet will even have benefits for the medication. Peak concentrations of Viagra occur in the blood in about an hour. A fatty meal, however, will delay the peak by about an hour and decrease the peak concentrations (Br J Clin Pharmacol 42:268P, 1996).

Viagra has obvious advantages over previously used approaches, such as psychological counseling, suction pumps, penile injections, insertion of tablets into the urethra, and surgical implantation of pumps, balloons, and plastic rods. No wonder it has been hailed as a wonder drug by men. The first week Viagra was on the market I had requests from 3 men in the McDougall Program at St. Helena for a prescription (there were only 5 men in that program). Patients picked up 906,368 new prescriptions for Viagra from April 3 through May 8, 1998. On the Internet you can place your order for the drug, but it won’t be filled until the doctor’s prescription arrives.

Viagra was discovered by researchers looking for a new kind of blood pressure pill. The medication was ineffective for lowering blood pressure, but none of the men returned the pills. Viagra works by enhancing changes in blood flow in the penis that normally occur to cause an erection. Tactile, visual, auditory, and imaginative stimuli cause an increased flow of blood into the penis, and close the flow out of the penis. The result is two large blood-filled sacks, the corpora cavernosa, become engorged with blood and the penis stands erect. Viagra enhances the build up of a specific substance (cyclic guanosine monophosphate-specific phosphodiesterase) that is released during arousal, and mediates the desired changes in blood flow. Because its mode of action only enhances something that normally occurs, an erection only happens with sexual stimulation. Because of this, only men with a normal level of sexual desire would be expected to be helped. Side effects, too, are due to the build up of this same substance in other parts of the body.

The only other human study on Viagra was published in the British Journal of Urology in August of 1996 (78:257). Twelve patients (aged 36-63 years) with erectile dysfunction of no established organic cause were studied. Measurement of penile rigidity was made during visual sexual stimulation at different doses of Viagra or placebo. Duration of rigidity of the penis was 1.3 min in patients on placebo, 3.5 min on 10 mg, 8.0 min on 25 mg, and 11.2 min on 50 mg of Viagra. Ten of 12 patients reported improved erectile activity while receiving Viagra, compared with two of 12 on placebo (P = 0.018). Six patients on active treatment and five on placebo reported mild and transient adverse effects which included headache, dyspepsia and pelvic musculo-skeletal pain.

Since there is so little reported research on Viagra many questions still have to be answered. Are there other short term and long term side effects yet to be discovered? Pfizer reported on May 22, 1998 to the Food and Drug Administration six deaths among Viagra patients. It's too early to say if Viagra played any role. People with erectile dysfunction are older and tend to frequently suffer from serious underlying health conditions, such as diabetes or cardiovascular disease, so you would expect a higher risk of deaths.

Patients who are taking nitroglycerin or other nitrates should not take Viagra, because both dilate blood vessels, the combination increasing the risk of death. Tagamet, erythromycin, Nizoral, Sporanox, Posicor increase the concentrations of the drug in the blood and Rifampin decreases effects.

Other outstanding questions are: Will it enhance the sexual performance for men without erectile dysfunction? Will women receive similar benefits with their sexual performance? Should insurance companies pay for this medication to treat this recognized medical condition, which is not only the most common, but also the most threatening, distressing, and embarrassing sexual problem for men?

SUGAR RAISES TRIGLYCERIDES

Human fatty acid synthesis is reduced after substitution of dietary starch for sugar by Lisa Hudgins in the April 1998 issue of the American Journal of Clinical Nutrition found very-low fat diets that contain only simple carbohydrate markedly increase the synthesis of fatty acids to produce triglycerides in healthy people (67:631). The addition of starch (complex carbohydrate) reduced the production of fatty acids.

COMMENT: Many people fail to understand that a low-fat diet does not necessarily mean a diet that will prevent heart disease or cause you to lose weight. Simple sugars actually cause an increase in one risk factor for heart disease--triglycerides. Furthermore, triglycerides are the fats that go into the fatty tissues for storage.

Simple carbohydrates (sugars) are found naturally in fruits, whereas complex carbohydrates are found in starchy vegetables (like whole grains, legumes, and roots), and green and yellow vegetables. In processed foods, especially in drinks, desserts, and snacks, simple sugars are voluminous. I see too many patients eating low-fat; meaning fat-free ice creams, puddings, yogurts, cookies, and cakes made from sugar--and they never lose weight or become healthier.

This misunderstanding that anything low-fat means healthy is also used by advocates of high protein diets to convince you that carbohydrates are bad for you. They point out that carbohydrates raise triglyceride levels. This study is one of many that shows this happens with simple sugars, but not with complex carbohydrates.

BP PILLS AND DEPRESSION

Use of calcium channel blockers and risk of suicide: ecological findings confirmed in population based cohort study by Gunnar Lindberg in the March 7, 1998 issue of the British Medical Journal found the use of calcium channel blockers may increase the risk of suicide (316:741). They compared the use of this class of blood pressure pills with the rates of suicide in 152 municipalities in Sweden and found a correlation, which they did not find with the use of other classes of blood pressure pills. The relative risk, adjusted for differences in age and sex, among users versus nonusers was 5.4.

COMMENT: An association of depression with the use of calcium channel blockers has previously been reported in several studies. This study carried that research forward looking at suicide which often follows depression. Patients who used calcium channel blockers had more than five times the risk of suicide compared to nonusers. These drugs easily pass from the blood into the nervous system where they can have effects on the nerves, neurochemicals, and receptors involved in mood. Most drugs used to treat heart disease and high blood pressure have effects on mood, however, calcium channel blockers seem to be the worst.

Calcium channel blockers (antagonists) are dangerous medications used to lower blood pressure and treat some forms of heart disease (angina and arrhythmias, for example). Previous McDougall Newsletters have dealt with the hazards of these medications: Doubling the Risk of Breast Cancer--Nov/Dec 1997; Causing an Increase in Cancer--Sept/Oct 1996; Gastrointestinal Bleeding--May/Jun 1996; and Heart Disease--Sept/Oct 1995. Yet calcium channel blockers are annually an 8 billion dollar business that can buy expert’s opinions--like other pharmaceutical manufacturers.

DRUG COMPANIES BUY DOCTORS

Conflict of interest in the debate over calcium channel antagonists by Henry Stelfox in the January 8, 1998 issue of the New England Journal of Medicine found, "Authors who supported the use of calcium channel antagonists were significantly more likely than neutral or critical authors to have a financial relationship with manufacturers of calcium channel antagonists (96 percent vs. 60 percent and 37 percent, respectively)." (338:101) Critical authors were also more likely to be associated with manufacturers of competing products. "We wonder how the public would interpret the debate over calcium channel antagonists if it knew that most of the authors participating in the debate had undisclosed financial ties with pharmaceutical manufacturers."

COMMENT: Pharmaceutical manufacturers provide money for a doctors’ educations throughout their careers, and for research that guides doctors’ decisions. Noontime educational luncheons sponsored by pharmaceutical manufacturers occur weekly in almost every hospital countrywide, drug salespeople flood doctors’ offices daily, and most of our continuing education conferences have a pharmaceutical manufacturer’s sponsorship. Obviously, money influences the kind of care you get. And the pharmaceutical industry rules big money.

TAMOXIFEN FOR BREAST CANCER

Tamoxifen for early breast cancer: an overview of the randomised trials by the Early Breast Cancer Trialists’ Collaborative Group in the May 16, 1998 issue of the Lancet found benefits from Tamoxifen for women with breast cancer regardless of their age, menopausal status, daily tamoxifen dose, and of whether chemotherapy had been given (351:1451). Proportion of mortality reductions were similar for women with node-positive and node-negative disease. Cancer of the uterus was doubled with 1 to 2 years of tamoxifen use and quadrupled after 5 years (Tamoxifen has estrogen stimulating effects that can cause endometrial cancer, in addition to its blocking effects that benefit breast cancer).

COMMENT: I can only imagine that sometime in the recent past, cancer doctors working hand in hand with pharmaceutical companies must have gotten together and divided up the breast cancer business. The side of the business profiting from toxic chemotherapy got the premenopausal women, which are mostly those with estrogen receptor negative tumors. The tamoxifen side got the postmenopausal women with mostly estrogen positive tumors. I could never understand any sound scientific reason to treat these women so differently because the studies as far back as the early 1980s showed all women, regardless of menopausal or estrogen receptor status benefited from the less toxic tamoxifen therapy (Lancet 1:257, 1983). Likewise, those with positive and negative lymph nodes under their arm benefited from Tamoxifen.

Estrogen stimulation should be reduced after initial breast cancer surgery (I recommend a lumpectomy with clear margins). Tamoxifen works by blocking the growth-stimulating effects of estrogen on the tumor. Chemotherapy is believed to work by destroying a woman’s ovaries and in that way reducing the stimulating effects of estrogen on her tumors. However, I think a year of sickness with vomiting and hair loss is an inhumane way to reduce a woman’s estrogens. The simplest, safest, and most economical means of removing ovary function is by laparoscopy surgery (Surg Laparosc Endosc 7:223, 1997).

MAMMOGRAMS AND FALSE POSITIVES

Ten-year risk of false positive screening mammograms and clinical breast examinations by Joann Elmore in the April 16, 1998 issue of the New England Journal of Medicine found over a period of 10 years of screening one-third of women had abnormal test results requiring additional evaluation, even though no breast cancer was present (338:1089). The estimated accumulative risk of a false positive mammogram was nearly 50 percent with 18.6 percent of women undergoing a biopsy after 10 mammograms.

COMMENT: That’s a lot of testing and surgery following an x-ray examination that has questionable benefits, even for women over 50 (Lancet 346:29, 1995). False positive mammograms and clinical breast examinations by doctors result in anxiety, complications, scars, and costs. After a false positive mammogram, 26 percent of women report worry and anxiety 3 months after they have been told they don’t really have breast cancer (Ann Intern Med 114:657, 1991). My recommendations are that women under 50 and over 69 should avoid routine screening. Those between these ages should understand that the benefits are far oversold. Two studies show statically significant benefits for women over 50, the other six don’t! (J Natl Cancer Inst 85:1644, 1993). Late next fall The McDougall Program for Women will be out with an exposing chapter on mammography.

ASTHMA FROM RICH FOODS

Worldwide variation in prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and atopic eczema: ISAAC by the International Study of Asthma and Allergies in Childhood (ISAAC) Steering Committee in the April 25, 1998 issue of the Lancet found asthma most common in UK, Australia, New Zealand, and Republic of Ireland; and least common in several European Eastern Countries, Indonesia, Greece, China, Taiwan, India, and Ethiopia (351:1225). The places of lowest prevalence for allergic rhinoconjunctivitis and eczema were similar to those of asthma.

COMMENT: You might think respiratory diseases, like asthma and rhinitis (runny nose), and conjunctivitis (inflamed eyes), would be most common where pollution was worse. However, that’s not what the worldwide pattern shows. These allergic diseases are common in affluent nations where pollution levels are generally low.

Based on what I know about their cause and the experiences I have had with treating these allergic problems, I would have predicted these findings, because, again, it’s the food. Dairy products have been linked to all of these allergic conditions, and removal of dairy from the diet has profound benefits for the patients. Other highly allergic foods, like eggs, probably play a role too. Rich foods also lead to acid indigestion and acid reflux. The refluxed acid travels to the back of the throat where it is inhaled, burning the bronchial tubes and causing the bronchospasm and mucus production, characteristics of asthma. That same stomach acid is breathed into the sinus passages causing rhinitis, and sinusitis.

The solution to these problems is a starch-based diet. Removal of the dairy and egg products often stops these allergic reactions. A change in diet calms the stomach and usually stops the acid reflux. Raising the head of the bed will also help keep the acid out of the back of the throat. Finally antacids may be needed to counteract the acid.