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

Drug Information Never Reaches Clinicians

FDA drug information that never reaches the clinician

Important information regarding the benefits and harms of FDA approved prescription drugs, does not make its way into the hands of the clinician - writes Lisa Schwartz in the New England Journal of Medicine. The FDA is the American drug regulatory body. Drug labels (package inserts) are the direct way of communicating prescribing information to physicians- but they are written by the drug companies and then negotiated or approved by the FDA. Drug approval requires that preclinical studies and the results of at least two phase 3 studies in patients - are submitted to highly qualifed FDA experts which may take a year to evaluate. The FDA produce review documents recording the reasoning behind approval. These are lengthy and can be complex - the problem seems to be that important information is getting lost - and never makes it onto a drug label. The authors report a number of possible harms - which fail to make it onto the drug labels, but also efficacy data that can be useful, but again is lost from the final drug sheets.

The FDA has recognised some problems with drug labels and in 2006 introduced a highlights section to emphasize drug warnings and indications. It has also issued guidance about reporting trial results in labels - but in at least 2 drugs studied, labels remained unimproved.

It seems that a better way of communicating information that is already known, but not passed into the clinicians hands must be expedited.

Source

WEB: http://content.nejm.org/cgi/content/full/361/18/1717