January 2007

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Vol. 6, No. 1   

Favorite Five Articles from Recent Medical Journals

The Food Industry Buys Nutrition Research—
Threatening Your Family’s Health

Relationship between Funding Source and Conclusion among Nutrition-Related
Scientific Articles
by Lenard I. Lesser in the open access journal PLOS Medicine concluded, “Industry funding of nutrition-related scientific articles may bias conclusions in favor of sponsors’ products, with potentially significant implications for public health.”  The main finding of this study is that scientific articles about commonly consumed beverages funded entirely by industry were approximately four to eight times more likely to be favorable to the financial interests of the sponsors than articles without industry-related funding.  Of particular interest, none of the interventional studies with “all industry support” had an unfavorable conclusion.

The authors state further that, “When an industry is the major sponsor of research on its own product, unfavorable effects of that product are less likely to be investigated. The next step down the slope is adjustment of designs. The dosage of the product and the nature of control treatments may be adjusted so as to increase the chance that the study will demonstrate benefits of the product or that adverse effects will not reach statistical significance. Also, unfavorable data may be deemed less relevant and may be left out of the abstract and the press release, or out of the paper itself. Finally, the whole publication may be cancelled or seriously delayed when the outcome is disappointing to the sponsor.” 

This study reviewed articles about soft drinks, juice, and milk published between January 1, 1999 and December 31, 2003.


Ways That Industry May Influence Outcomes of Studies 

1) Fund only those studies that they believe will present their products in a favorable light, or their competitors’ products in an unfavorable light.

2) Formulate hypotheses, design studies, or analyze data in ways that are consistent with the financial interests of their industrial sponsors.

3) Choose to delay or not publish findings that have negative implications to the sponsor’s product. Researchers sign contracts that allow the sponsor to veto publication.

4) Search and interpret the literature selectively, in ways consistent with the sponsor’s interests.

5) Scientific reviews arising from industry-supported scientific symposia, often published as journal supplements, may over- or under-represent certain viewpoints. Presenters whose opinions conflict with the sponsor’s financial interests are not invited to participate.


When I read a scientific study in a medical journal, I first look for the source of funding.  This nugget of information foretells what I am likely to read in the article and why the researchers have reached their conclusions.  Contamination of the research is so great that I trust no paper published with industry funds—such as from food, pharmaceutical, testing, or device industries.  When the funding sources are not clearly identified in a suspicious paper, I will look at other papers written by the authors to see if they have worked for an industry favored by the article in the past.

Anyone serious about knowing the truth about human nutrition and working from a solid foundation of knowledge needs to read the basic research on protein, fat, carbohydrates, oils, milk and meat that was performed from the late 1800s to the 1970s; at a time when researchers did not have their hands in the pocketbooks of big business.  Much of this research is cited in my first 2 books: The McDougall Plan and McDougall’s Medicine—A Challenging Second Opinion.  Both can be purchased in our store as downloadable e-books.

Research on medications, tests, and surgical treatments published since the early 1970s is so contaminated by money that I do not know the true benefits and risks of the treatments I am asked to prescribe.  Even under these compromised circumstances, I have to make the best decisions possible for my patients.  When tests and treatments seem indicated, I choose the ones with the greatest safety and efficacy record; which are also the simplest and least expensive.  In the case of medications this usually means older and generic drugs.  My November 2004 newsletter discusses the few medications I commonly prescribe.

Lesser LI, Ebbeling CB, Goozner M, Wypij D, Ludwig DS. Relationship between Funding Source and Conclusion among Nutrition-Related Scientific Articles. PLoS Medicine Vol. 4, No. 1, e5 doi:10.1371/journal.pmed.0040005

How Long to Take Plavix and Aspirin after a DES (Heart Angioplasty Stent)

Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation by Eric L. Eisenstein published in the January 10, 2007 issue of the Journal of the American Medical Association found, “The extended use of clopidogrel (Plavix) in patients with DES (drug eluting stent) may be associated with a reduced risk for death (by 3.3%) and death or MI (by 4.5%) (at 24 months).   However, the appropriate duration for clopidogrel administration can only be determined within the context of a large-scale randomized clinical trial.”1  Of the 1501 patients in one group evaluated over the study period of almost 5 ½ years, “…14 patients receiving drug-eluting stents died or had a nonfatal MI, and none of these 14 patients was in the drug-eluting stent with clopidogrel group.”1

An accompanying editorial pointed out that, “For patients without contraindication, clopidogrel therapy should be continued through at least 1 year and possibly indefinitely until the time course of vulnerability for stent thrombosis in patients treated with drug-eluting stents is better defined.”2

Comment:  I see many patients who have had these drug-eluting stents (DES) placed in their heart arteries and are very worried about dying from a complication of very late stent thrombosis (blood clot formation closing down the artery). This often fatal complication occurs 9 to 12 months after surgery in about 0.5% of patients with DES—and can occur as late as 3 to 4 years after surgery.   My patients want to know what to do.  Based on this research my best recommendation at this time is to take the Plavix and aspirin as prescribed, indefinitely.  This treatment is not without risk “…bleeding events requiring transfusion were observed in 2.1% of patients followed up for a similar duration (approximately 2 years) to that of the current study.”2 

The reason DES may have this complication is the cancer chemotherapy drugs imbedded in the stent prevent healing after the surgery—stopping the cells of the artery lining from covering up the stent. The exposed stent is highly reactive and causes the blood to suddenly and tragically clot.

If you are at risk of having heart surgery (angioplasty) then you need to become fully informed quickly—read my Hot Topics section from my home page on heart disease.  I have discussed angioplasty therapy in detail in my September 2006 newsletter.

1)  Eisenstein EL, Anstrom KJ, Kong DF, Shaw LK, Tuttle RH, Mark DB, Kramer JM, Harrington RA, Matchar DB, Kandzari DE, Peterson ED, Schulman KA, Califf RM. Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation. JAMA. 2007 Jan 10;297(2):159-68.

2)  Kereiakes DJ. Does clopidogrel each day keep stent thrombosis away? JAMA. 2007 Jan 10;297(2):209-11.

Ear Tubes—Another Money Maker’s Benefits Disproved

Tympanostomy Tubes and Developmental Outcomes at 9 to 11 Years of Age by Jack L. Paradise in the January 18, 2006 New England Journal of Medicine found that, “In otherwise healthy young children who have persistent middle-ear effusion, as defined in our study, prompt insertion of tympanostomy tubes does not improve developmental outcomes up to 9 to 11 years of age.”

Comment: My young son, Patrick, at age 5 developed chronic fluid accumulation in his inner ears—most likely from abundant molds growing in the moist Hawaiian climate where we lived. The doctor I took him to 25 years ago recommended the placement of tubes in both ears to drain this fluid. He threatened me with his prediction that Patrick would lose his hearing and could become developmentally impaired with future speech, language, mental, and social difficulties.  I went to the medical library and discovered this was not true and that there were great risks from the surgery. He had no ear surgery and today he is a doctor (PhD) of organic chemistry and working at Stanford University in Palo Alto, California. Few parents stand a chance of defending their children against unnecessary surgery; especially when their doctors threaten permanent brain damage of their child if they refuse the ear tubes.

The placement of tympanoplasty tubes, also known as ventilation tubes, is one of the most common procedures performed on children. These tubes, open at both ends, are inserted into incisions made in the eardrums during a surgical procedure (myringotomy). They are left in place until they fall out by themselves or until removed by the doctor. Common complications include: chronically draining ears, infection, and hearing loss.

The condition that is usually being treated is chronic otitis media (an inflammation of the middle ear) and is accompanied by an accumulation of fluid in the inner ear (behind the eardrum).  The cause of this inflammation with fluid is usually allergy to substances present in the air and the food.  Dairy proteins are the most common cause of food allergy and this condition.2,3  A change in diet is often all that is needed to stop the inflammation and reverse the fluid accumulation.

If a change in diet does not stop the fluid and hearing loss becomes a problem, then the inner ears can be ventilated by using a bulb syringe, called a Politzer device. Air is blown through the nose into the eustachian tubes which temporarily opens the inner ear and drains the fluid. Hearing returns in 90% of cases.4  This simple cost-free treatment is done at home by the child or the parents.  We used the Politzer device on our son with great success.

1)  Paradise J, Feldman, H, Campbell T, Dollaghan C, Rockette H, Pitcairn D, Smith C, Colborn K et al.Tympanostomy Tubes and Developmental Outcomes at 9 to 11 Years of Age. N Engl J Med 2007;356:248-61.

2)  Bernstein JM.  The role of IgE-mediated hypersensitivity in the development of otitis media with effusion. Otolaryngol Clin North Am. 1992 Feb;25(1):197-211.

3)  Juntti H, Tikkanen S, Kokkonen J, Alho OP, Niinimaki A. Cow's milk allergy is associated with recurrent otitis media during childhood. Acta Otolaryngol. 1999;119(8):867-73.

4) Silman S, Arick DS, Emmer MB.  Nonsurgical home treatment of middle ear effusion and associated hearing loss in children. Part II: Validation study. Ear Nose Throat J. 2005 Oct;84(10):646, 648, 650

Antacids Promote Hip Fractures

Long-term proton pump inhibitor therapy and risk of hip fracture by Yu-Xiao Yang published in the December 29, 2006 Journal of the American Medical Association found “Long term PPI therapy, particularly at high doses, is associated with an increased risk of hip fracture.”  (PPI, or proton pump inhibitors, are powerful inhibitors of stomach acid production.)  The authors hypothesized that this increased hip fracture risk may be due to calcium malabsorption caused by the drug or by inhibition of bone cell activity.

This study compared 13,556 people with hip fractures to a control group of people. People taking PPI antacids for more than one year had almost twice the risk of hip fracture. Higher doses and longer use increased the risk of hip fractures.  The authors suggested doctors prescribe the lowest effective doses to patients with appropriate indications.

Comment: Doctors prescribe PPIs to treat people with heartburn, GERD (acid reflux disease), ulcers of the stomach or intestine, or a condition of relentless stomach acid overproduction, known as Zollinger-Ellison Syndrome.  Common examples of these medications are Prilosec, Nexium, Prevacid, AcipHex, and Protonix.

Protein, especially animal protein, in foods is a powerful stimulant for acid overproduction.2  Therefore, not surprisingly, indigestion is a very common problem for people eating the Western diet—just walk down the aisles of your local drugstore and see the multitude of intestinal remedies for sale.  This same animal protein is also the primary cause of bone loss, leading to osteoporosis, and to hip fractures.3,4  Therefore, it is likely that the association between PPI use and hip fractures has a common link to diet—in other words, people who eat a lot of animal protein develop osteoporosis and also have lots of indigestion, which leads to antacid use.

The solution to both problems is to eat an alkaline diet—one consisting of fruits and vegetables.  I must add a few precautions. Grains and legumes are slightly acidic and may need to be minimized in the diet of people who have any tendency towards osteoporosis—however, these foods do not usually cause any stomach upset. Indigestion is aggravated by raw vegetables, especially onions, green peppers, cucumbers, and radishes. Fruit juices (but not the whole fruits) commonly cause severe stomach burning, and so do spicy foods.  Beer and wine (but not distilled spirits) contain acids that cause indigestion.  Just by changing their diets almost all of our patients throw away their antacids the first day.  Additional benefit comes from raising the head of the bed 4 to 6 inches in order for gravity to pull the acid out of the esophagus and back into the stomach at night.  Wafer antacids (like TUMS) are a better choice.  They relieve acid indigestion and their alkaline makeup actually helps the bones maintain their strength by neutralizing very powerful dietary acids from hard cheeses, meat, poultry, eggs, fish, and shellfish.  For more information see the new book, Dr. McDougall’s Digestive Tune-up.

1) Yang YX, Lewis JD, Epstein S, Metz DC.  Long-term proton pump inhibitor therapy and risk of hip fracture. JAMA. 2006 Dec 27;296(24):2947-53.

2) McArthur KE, Walsh JH, Richardson CT. Soy protein meals stimulate less gastric acid secretion and gastrin release than beef meals. Gastroenterology. 1988 Oct;95(4):920-6.

3) Maurer M.  Neutralization of Western diet inhibits bone resorption independently of K intake and reduces cortisol secretion in humans. Am J Physiol Renal Physiol. 2003 Jan;284(1):F32-40.

4) Remer T.  Influence of diet on acid-base balance.  Semin Dial. 2000 Jul-Aug;13(4):221-6.

Complications Are Common from Colonoscopy

Complications of colonoscopy in an integrated health care delivery system by Theodore B. Levin published in the December 19, 2006 issue of the Annals of Internal Medicine found, “…that perforations occurred nearly once in every 1000 colonoscopies and that serious complications occur in 5 of every 1000. Removal of polyps through biopsy with a snare or forceps increases the risk for a serious complication nearly 9-fold compared with colonoscopy without biopsy. Postpolypectomy bleeding was the most common complication.”  

The study of 16,318 Kaiser patients who were over the age of 40 years at the time of testing found:

ü  Eighty-two serious complications occurred.

ü  Serious complications occurred in 0.8 per 1000 colonoscopies without biopsy or polypectomy.

ü  Serious complications occurred in 7.0 per 1000 colonoscopies with biopsy or polypectomy.

ü  Perforations occurred in 0.9 per 1000 colonoscopies.

ü  Postbiopsy or postpolypectomy bleeding occurred in 4.8 per 1000 colonoscopies with biopsy.

ü  Biopsy or polypectomy was associated with an increased risk for any serious complications.

ü  Ten deaths (1 attributable to colonoscopy) occurred within 30 days of the colonoscopy.

Comment: Colonoscopy is a test performed by specialty-trained gastrointestinal doctors and used to look at the interior lining of the colon (large intestine).  A thin, flexible 4 to 6 foot-long viewing instrument, called a colonoscope is used to detect ulcer, polyps, cancers and areas of inflammation or bleeding. During the procedure tissue samples can be collected (biopsy) and polyps can be removed. Colonoscopy is the most common test recommended for screening for colon cancer. Intervenous sedation is usually given.  Patients are often told that the risks from the procedure are very few and minor, and that the benefits far out-weigh the risks.  This study shows that in real-life medical practice (such as at Kaiser) the complications are not so uncommon and can be very serious.

The alternatives are a barium enema and sigmoid exam or a virtual colonoscopy when necessary to evaluate problems of the lower intestine and to look for precancerous polyps (screening).  Don’t overlook the fact that almost all problems of the intestines are caused by the foods you put in it and most of these disorders are quickly solved with a change to the McDougall Diet. For more information see the new book, Dr. McDougall’s Digestive Tune-up.

Levin TR, Zhao W, Conell C, Seeff LC, Manninen DL, Shapiro JA, Schulman J.  Complications of colonoscopy in an integrated health care delivery system. Ann Intern Med. 2006 Dec 19;145(12):880-6. 


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