Vioxx and Celebrex May Give You a Heart Attack and More

A coxib a day won't keep the doctor away by Eric J Topol in the August 21, 2004 issue of the Lancet explains the true risks and lack of benefits of the new generations of pain relievers.*  The issue’s cover headline summarizes the researcher’s findings by stating, “It is hard to imagine the justification for this extraordinary adoption of coxibs (like Vioxx, Celebrex, and newer versions) in light of marginal efficacy, heightened risk, and excessive cost, compared with traditional NSAIDs (like Motrin, Advil and plain aspirin).” 

Comment:  In the USA alone $7 billion dollars a year are spent on these “high-tech” anti-inflammatory, prescription painkillers – since these new “improved” drugs are able to be protected by patented laws, they are highly profitable.  Vioxx and Celebrex will cost you $4 a tablet, whereas you can buy generic Motrin or Advil for 10 cents a piece and plain aspirin tabets – which are as effective and safer – cost much less than a penny each.

Unless there is some reason to act otherwise, I suggest my patients use simple, time-tested medications to relieve pain, such as aspirin and Tylenol (acetaminophen).  Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) and it has added benefits over other NSAIDs, like protection from heart disease.  If you prefer a next generation NSAID, then choose something over-the-counter and inexpensive, like ibuprofen (Motrin or Advil).  Remember all drugs have potentially serious side effects and you should become familiar with these before you use any medication.  Better yet, you should relieve the cause of your suffering through a better diet.  For example, most cases of arthritis, even serious rheumatoid arthritis, can be dramatically benefited (often cured) with a low-fat, pure vegetarian diet. (See my home page article:  “Diet:  Only Hope for Arthritis,” and read the Star McDougallers" articles – Jean Brown, Vanessa, Sabrina, Mayra, and Rolling Back Dermatitis... These are all found on my web site at www.drmcdougall.com.)

* A coxib a day won't keep the doctor away.  Lancet. 2004 Aug 21;364(9435):639-40.

Conservative Breast Cancer Treatment Best – No Mastectomy, No Radiation

Lumpectomy plus tamoxifen with or without irradiation in women 70 years of age or older with early breast cancer, in a study by Kevin S. Hughes in the September 2, 2004 issue of the New England Journal of Medicine found lumpectomy plus hormone therapy with tamoxifen alone is a realistic choice for the treatment of women 70 years of age or older who have early, estrogen-receptor-positive breast cancer.*  Radiation added nothing to the chances for living longer.  The risk of recurrence in the breast area increased from 1% to only 4% over five years when radiation was not used and those who had a recurrence were easily treated at that time with a little more surgery – but even then they avoided a mastectomy in almost all cases (98% of the time mastectomy was not needed).

Comment:  More than 20 years ago I began writing about and recommending the kind of conservative treatment reported here by Dr. Hughes. Since then I estimate in the USA alone more than 2 million women have been mutilated by unnecessary mastectomy, and more than one million have undergone radiation, believing incorrectly that these treatments would prolong their lives.  The reason for the failure of these treatments has been known for more than 50 years – breast cancer is usually a slow growing disease – taking about 14 years to kill half of its victims, but some women live 35 years and more with active disease. 

Unfortunately, by the time it is discovered, if it is the aggressive kind, the cancer has already spread beyond the reach of these local treatments – surgery and radiation.  Many breast cancers are, however, not aggressive and would not threaten a woman’s life even if left untreated.  By understanding this natural history of the disease, you will understand why conservative therapy is almost always best.  This article limits the findings to women 70 years of age and older.  However, the same principles apply to women of all ages with breast cancer.  Furthermore, this study was limited to women with “estrogen-receptor-positive tumors,” but the fact is that “estrogen-receptor-negative tumors” also respond to Tamoxifen.

This article by Dr. Hughes and his associates suggests that at least a few doctors understand why most women do not need aggressive therapy.  However, don’t count on the rest of the profession to catch up any time soon – doctors are very slow to change, and the fact that mastectomy, radiation, and chemotherapy are high-profit procedures doesn’t help the medical profession move into the 21^st century any faster.

Tamoxifen is an anti-estrogen medication that will prolong survival and seems to reduce local recurrences.  For the past thirty years I have been treating my patients with breast cancer with a simple surgical removal of the obvious tumor (lumpectomy) and Tamoxifen – no routine radiation, no lymph node dissection, and no chemotherapy.  I always encourage them to take advantage of a low-fat, pure vegetarian diet – in other words, improving the quality and quantity of their life by removing the cause of their breast cancers.  You can read about two of my patients who have elected diet-therapy and have done well for more than 20 years – see Star McDougallers Anneliese Moore and Ruth Heidrich at www.drmcdougall.com.  Also read my book, the McDougall Program for Women, with four chapters on breast cancer.

* Hughes KS, Schnaper LA, Berry D, Cirrincione C, McCormick B, Shank B, Wheeler J, Champion LA, Smith TJ. Lumpectomy plus tamoxifen with or without irradiation in women 70 years of age or older with early breast cancer.  N Engl J Med. 2004 Sep 2;351(10):971-7.

Time to Quit Using the PSA says Stanford University

The prostate specific antigen (PSA) era in the United States is over for prostate cancer:  What happened in the last 20 years by Thomas Stamey from Department of Urology, Stanford University School of Medicine, in the October 2004 issue of the Journal of Urology concludes: the use of  PSA tests has led to overly zealous treatment of men with prostate enlargement (hyperplasia) – men who do not have actual cancer.*  Prostate cancer is being over-diagnosed and over-treated, and the current extensive use of PSA screening is unwarranted.

Comment:  Please refer to my February and March 2003 newsletter lead articles (see the archives at www.drmcdougall.com) for a thorough discussion of the harms caused to men by the use of the PSA test, and the proper approach to prevention and treatment of this common disease.  

The PSA test is inaccurate and fails to catch the cancer at a stage early enough to be treated effectively by surgery or radiation.  Prostate cancer begins in men in their twenties and steadily increases in incidence as they age until by their seventies, about 80% of men are found to have this cancer.  With prostate cancer this common, any excuse to perform a biopsy is likely to find cancer in men over the age of fifty.  This research shows (again) that the PSA tests do not increase the odds of finding prostate cancer over chance alone (by serendipity), and does not help the doctor determine which men need to be treated.  PSA levels reflect mostly the size of the prostate as it enlarges with benign (non-cancerous) hyperplasia.

Even though prostate cancer occurs in most men, it has an extraordinarily small risk of killing the patient:  the death rate is 226 per 100,000 men older than 65 years old.  Yet if all men were biopsied, at this age about 80,000 men out of 100,000 would be told they have prostate cancer, and would be treated aggressively with surgery, and/or radiation.  Sadly, 79,774 men would only be harmed by this testing because they were at no risk of dying from this disease.  Even the 226 who died of prostate cancer failed to receive benefit, because in these cases the cancer had obviously already spread beyond the reaches of surgery and radiation (they were not cured).  Yet all this truth published in the world’s best scientific-medical journals will not change the practice of your doctors – you are left to protect yourself from this dishonesty.

My advice has been for men to not get a routine PSA blood test or digital rectal examination.  If a man has already been found to have prostate cancer, then in most cases he is better off doing nothing medically, often referred to as “watchful waiting.”  Prostate cancer is caused by the rich Western diet.  Therefore, common sense would dictate that victims of this disease “stop throwing gasoline on the fire,” and change their diet.  The diet for preventing and treating prostate cancer (like breast cancer) is a low-fat, plant-food-based diet.  The benefits of hormone therapy (analogous to the anti-estrogen drug, Tamoxifen, used for breast cancer) are yet to be determined.  My guess is that these anti-testosterone medications will be found to be only minimally beneficial for men who have prostate cancer.

* Stamey TA, Caldwell M, McNeal JE, Nolley R, Hemenez M, Downs J.  The prostate specific antigen (PSA) era in the United States is over for prostate cancer:  What happened in the last 20 years.  J Urol. 2004 Oct;172(4, Part 1 Of 2):1297-1301.

Vaginal Yeast Not Helped By Lactobacillus Pills or Inserts

Effect of lactobacillus in preventing post-antibiotic vulvovaginal candidiasis: a randomized controlled trial by Marie Pirotta in the September 4, 2004 issue of the British Medical Journal found that the use of oral or vaginal lactobacillus preparations had no effect on vaginal infections caused by a course of antibiotics.¹  Women were instructed to use one or both preparations during the entire course of antibiotic therapy and to continue four days after the antibiotic was stopped.  Of the 235 women treated with lactobacillus preparation or a placebo, 55 developed a vaginal infection, with yeast called candida. There was no difference in the infection rates between the two treatment groups.  The authors were so confident with their findings that they said, “Further research on this subject is unlikely to be fruitful…” and that they (women) should use proven antifungal treatments if they developed yeast infections.

Comment:  Inflammation of the vagina with itching and discharge can be caused by infections with microbes, such as parasites, bacteria, or yeast.  Transmission by sexual relations is the usual means of contracting parasites and bacteria.  Yeast (candida) naturally occurs all around us but its infectious potential is usually kept in balance, preventing an overgrowth that would cause vaginitis.  Sometimes conditions tip this balance in favor of the yeast and it is allowed to grow out of control; for example, when the excess sugars from diabetes feed the yeast, or when antibiotics kill the “friendly” vaginal bacteria – which usually keep the yeast in check.

The theory behind using lactobacillus bacteria pills and vaginal inserts is that they are supposed to return the natural balances in the bacteria in the vagina and prevent or cure yeast infections.  For years women have used yogurt (which contains lactobacillus), orally and vaginally, and recently this bacteria has been available in natural food stores sold as pills called “probiotics.”  A recent thorough review of the literature failed to find convincing evidence for benefits.²    This article and the review should quell some of the enthusiasm for this “natural” approach to vaginitis.

My experience has been that women who follow a healthy diet, exercise, and as a result become fit and trim, have very little trouble with yeast infections.  Most likely, the benefits are a direct result of an enhanced immune system and lower blood sugars (even if women are not truly diabetic, their blood sugar decreases to a healthier level).  Furthermore, the best means for you to grow healthful bacteria in your bowel and vagina, thus inhibiting the growth of yeast, is for you to eat vegetables and fruits.  These healthful bacteria thrive off the partially digested remnants of healthy plant foods.  I also recommend women with vaginal yeast infections use over-the-counter creams, such as miconazole (Monistat) or clotrimazole (Gyne-Lotrimin), when they have obvious discharge due to candida.

1)  Pirotta M, Gunn J, Chondros P, Grover S, O'Malley P, Hurley S, Garland S.  Effect of lactobacillus in preventing post-antibiotic vulvovaginal candidiasis: a randomised controlled trial. BMJ. 2004 Sep 4;329(7465):548.

2)  Jeavons HS.  Prevention and treatment of vulvovaginal candidiasis using exogenous Lactobacillus.  J Obstet Gynecol Neonatal Nurs. 2003 May-Jun;32(3):287-96.

Echinacea Fails Again – What Am I Going to Do during Cold Season?

Echinacea purpurea therapy for the treatment of the common cold: a randomized, double-blind, placebo-controlled clinical trial by Steven Yale in the June 14, 2004 issue of the Archives of  Internal Medicine found that Echinacea did not effectively reduce the symptoms and duration of the common cold.  This conclusion was reached after studying 128 patients enrolled within 24 hours of cold symptom onset who were treated with 100 mg of an Echinacea preparation of freeze-dried pressed juice from the aerial portion of the plant, and compared with a placebo.¹

Comment:  This is the third major study in the past five years that has failed to find benefits from this supposedly immune-system-enhancing herb.^2,3  (But I still have a bottle on my medicine shelf next to my Vitamin C for use when I think I am getting a cold – I am hoping for placebo effect at least.)

So with cold and flu season approaching what can you do?

Prevention is the best approach, like avoiding sick people. Hand washing is highly effective – do this whenever you have a chance.  Too much exercise suppresses your immune system and increases colds and flu.  Fish/flaxseed (omega-3), and other vegetable oils, can reduce your immune function and encourage infectious illnesses (and probably cancer).  Animal foods, including fish, also impair your disease-fighting abilities.  A healthy, low-fat, plant-based diet enhances immune function.  You also might consider a flu shot (vaccination) – although there is much controversy about the benefits and risks, I usually get one.

Once you are ill, raising your body temperature by submersion in a hot bath may help.  During your illness, you can benefit from medications that relieve the symptoms, such as cough syrups with dextromethorphan, nasal sprays for congestion and sneezing, and aspirin.  (See my October 2003 Newsletter article:  “Surviving the Cold Season” for more information and references for the above statements.)

1) Yale SH, Liu K.  Echinacea purpurea therapy for the treatment of the common cold: a randomized, double-blind, placebo-controlled clinical trial.  Arch Intern Med. 2004 Jun 14;164(11):1237-41.

2)  Barrett BP, Brown RL, Locken K, Maberry R, Bobula JA, D'Alessio D.   Treatment of the common cold with unrefined echinacea. A randomized, double-blind, placebo-controlled trial.  Ann Intern Med. 2002 Dec 17;137(12):939-46.

3)  Grimm W, Muller HH.  A randomized controlled trial of the effect of fluid extract of Echinacea purpurea on the incidence and severity of colds and respiratory infections. Am J Med. 1999 Feb;106(2):138-43.