No Wonder You Can't Trust Clinical Studies

Journal Watch

About Journal Watch

Written weekly by Dr Richard Lehman MD, Journal Watch provides a personal comment on articles from the main medical journals selected for their interest to doctors (and a few others!)

One Click Extract: NEJM  4 Nov 2010 Vol 363

The New England Journal describes itself as the world's leading medical journal and I wouldn't argue with that. Every now and again, though, its papers are of such a rarified nature that a mere GP cannot hope to apply their undoubted wisdom and excellence to his personal practice. You and I shall never use recombinant activated Factor VII in a heavily bleeding patient, which is probably just as well, because it might kill people; we shall never have the satisfaction of seeing the subependymal astrocytomas of tuberous sclerosis shrink under the influence of everolimus; nor indeed are we likely to use brentuximab vedotin in relapsed CD30-positive lymphomas; while advances in haemodialysis we leave in the capable hands of our learned friends, the nephrologists. I have no objection to such rarefaction on the part of the NEJM editors because these are life-and-death matters for many people around the world. Moreover, I can't fault the journal's stance on many of the important debates in medical politics, including criticism of the role of some major pharmaceutical companies, such as GSK in relation to rosiglitazone. 

But in one of his latest blogs, Richard Smith reminds us that high-faluting does not come cheap, and 32% of papers published by the NEJM relate to studies paid for by drug companies, who then pay the journal up to $1M for reprints. It is this sort of thing that led Marcia Angell to her depressing conclusion that "it is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of the New England Journal of Medicine."
 
http://www.nejm.org/doi/full/10.1056/NEJMoa1006221
http://www.nejm.org/doi/full/10.1056/NEJMoa1001671
http://www.nejm.org/doi/full/10.1056/NEJMoa1002965
http://www.nejm.org/doi/full/10.1056/NEJMra0902710

For more information please go to  http://blogs.bmj.com/bmj/2010/11/02/richard-smith-on-editors-conflicts-of-interest/

or here



just as Novartis plans to microchip your pills, transplant patients take heed! 

Consider Health News Review dot org for more of a discussion of this issue and current mis-reporting in mainstream media on omega 3

Recently on CBS News Couric reported erroneously on omega 3.

If you read this study you will notice that the form of DHA capsule that was utilized was from red algae. 

Red algae does supply some omega 3 in the form of DHA.  This is incomplete as it does not have the EPA component.

Some people cannot convert DHA to EPA and for this reason some supplements like flax oil are not always useful in certain populations.

The same can be said for vegetarian forms of omega 3 like algae (all ALA forms)

DHA is an omega-3 fatty acid made from another fatty acid called alpha-linolenic acid. ALA is found predominantly in flaxseed oil (also known as linseed) and hemp seed oil. Green leafy vegetables, soybeans, walnuts, and canola oil have small amounts of omega-3 fatty acids. Omega-3 fatty acids are beneficial because they provide fluidity to cell membranes and improve communication between brain cells. Omega-3s also reduce the clotting ability of platelets, thus potentially decreasing the incidence of heart attacks and strokes. Two very important omega-3 fatty acids are eicosapentanoic acid (EPA) and docosahexanoic acid (DHA). They are found in seafood, especially mackerel, salmon, striped bass, rainbow trout, halibut, tuna, and sardines. Supplements of fish oils that contain EPA and DHA are sold over the counter. DHA is also sold by itself, usually from an algae source. In the body, DHA is found mostly in the brain, retina, and in sperm. DHA plays an important role in vision.

DHA is thought to be helpful to people with diabetes.

But in general a person needs to take fish oil and DHA to get the full benefit of omega 3.

Also the report did not provide ANY information about the dose and frequency.

Some smaller, less rigorous studies suggested that mental decline could be slowed or prevented by eating fish, the main dietary source for omega-3 fatty acids, or supplements like fish oil pills that contain fatty acids including DHA. The study used capsules of DHA oil derived from algae.

Generally the accepted dose is 1000 to 3000 mg daily.  Fish based omega 3 is the effective form.

I'd suggest that  you have your news readers refer to Health News Review (dot org) for sound guidelines in health reporting, or at least make an effort to get all the facts before offering the public incomplete information that could be harmful to their health.

Thank you,

Dr Gayle Eversole

I have had no reply from CBS or heard a correction of the mis-information.

See also

NO CHANGE: Big Insurance

18 September 

Aetna granted 19% increase

Aetna gets OK to hike rates on individual health policies in California
The increase will average 19% and will take effect Oct. 1 along with double-digit hikes by Anthem Blue Cross, Blue Shield of California and Health Net that also had been reviewed by the Department of Insurance.

United Health is promoted by AARP and owned in a major part by Big PhRMA Novartis.

California regulators seek up to $10 billion in fines from PacifiCare

The health insurer violated state law nearly 1 million times from 2006 to 2008 after it was bought by UnitedHealth Group, the Department of Insurance says.

by Duke Helfand

California regulators are seeking fines of up to $10 billion from health insurer PacifiCare over allegations that it repeatedly mismanaged medical claims, lost thousands of patient documents, failed to pay doctors what they were owed and ignored calls to fix the problems.

In court filings and other documents, the California Department of Insurance says PacifiCare violated state law nearly 1 million times from 2006 to 2008 after it was purchased by UnitedHealth Group Inc., the nation's largest health insurance company by revenue.

Regulators say the companies broke promises to maintain smooth operations for 130,000 of PacifiCare's customers, resulting in what insurance regulators nationwide believe is the largest fine ever sought against a U.S. health insurer.

Double Standard

So what else have we come to expect?

The FDA just must be in a state of brain fog -

NOVARTIS, the big pharmaceutical company uses Guar Gum in their product Benefiber. The FDA says that one person died from using this product in supplements.

T92-14, Guar Gum The article herein was written in 1992, maybe it is the money that makes one wonder what hasn't changed.

March 18, 1992

FDA ORDERS NATURE'S WAY GUAR GUM DIET PILLS OFF MARKET

FDA has received numerous inquiries about action taken recently by 10 states and the FDA against diet drug products containing guar gum. The following may help in responding to questions.

In a nationally coordinated effort, FDA and 10 states moved to stop the sale off a weight control drug product containing guar gum, an ingredient determined by FDA to be unsafe for weight control. FDA warned Nature's Way Products, Inc., of Springville, Utah, to stop distributing its East Indian Guar Gum capsules and to remove them from the market immediately.

Acting in concert with FDA, attorneys general in 10 states ordered General Nutrition Centers, the major distributor of the capsules nationwide, to stop selling them. They also ordered General Nutrition Centers to recall and destroy all other diet products containing guar gum. Failure to do so could result in civil penalties. The nationally coordinated action by FDA and the state attorneys general is the first of what are expected to be more joint enforcement actions against health fraud, deceptive practices and other violations of federal and state food and drug laws. FDA banned the use of guar gum in nonprescription diet drug products after numerous reports that the ingredient presents a health hazard. The agency also banned 110 other weight control ingredients in these products because none had proven effective. Guar gum was found to be neither safe nor effective. Guar gum is a complex sugar that swells when it becomes wet and is purported to create a sense of fullness when ingested. Diet drug products containing guar gum have caused numerous cases of esophageal, gastric and intestinal obstruction. Many people affected required hospitalization, and one eventually died as an indirect result of esophageal obstruction. Although the ingredient is banned in weight loss drug products, it is approved for use in small amounts in foods such as cheese, salad dressings and ice creams. This use is not a health concern.

In a letter to Nature's Way, FDA cited both use of a banned ingredient and claims on the label that make the product a new drug, requiring FDA approval before it can be legally marketed. East Indian Guar Gum capsules claim to promote weight control, regularity and digestion, and to control glucose and reduce cholesterol. Marketing a new drug without FDA approval is a violation of the Federal Food, Drug, and Cosmetic Act. FDA gave Nature's Way five days to advise the agency how it plans to comply with the law. Failure to do so could result in further regulatory action, such as seizure or injunction. FDA has moved against 14 manufacturers of guar gum diet drug products in the past couple of years. In July 1990, the agency told the marketer of Cal-Ban 3000 diet tablets and capsules to stop distributing those products and ordered distributors to recall supplies. U.S. Marshals subsequently seized more than 350,000 bottles of Cal-Ban 3000. In September 1991, a federal judge condemned the seized Cal-Ban 3000 as an unapproved new drug and ordered it destroyed.

http://www.fda.gov/bbs/topics/ANSWERS/ANS00386.html