Statin Article In New Enhttp://www.nejm.org/doal of Medicine

[lars999]

Hello All!!

Much to my surprise and satisfaction I found the following article in latest New England Journal of Medicine -- Online Edition. http://www.nejm.org/doi/full/10.1056/NEJMp1112023?query=OF&#t=article
TITLE: Needed: Pragmatic Clinical Trials for Statin-Intolerant Patients

As you read this you will see many things that we have come to learn the hard way, some we will applaud, some we will cuss. Also read the references.

Lars

[lars999]

Hello All!!

Pleased to see than over 100 folks have accessed this thread and apparently read the New England Journal of Medicine opinion article. What leaves questions in my mind is why no one has commented on that article.

I have sent link to that article to various people I have helped get themselves or someone close to them off statins. They were all pleased to see that a medical journal with high standing of NEJM would publish such an article, even if it is "only" an opinion article.

Lars

[Allen1]

Hi there Lars,

I must admit that I am one of those folks who read the article and never got back to remark on it.

It is definitely good news to see that someone ie Patricia Maningat, M.D., and Jan L. Breslow, M.D. has taken the problem seriously and wrote that article, its also written in such a way that there can be no misunderstanding about how only selected candidates are used in trials and what happens to the rest of us when stuff like Statins is released on the general population.

Something like this would have made all our doubts and worries about our symptoms and sanity, so much more credible if we had been armed with such information about Statin intolerance when we were first going through all our problems, doctors as we all know, really didn't believe the problems were real or maybe they were just in our imagination.

It has been 3-4 years since I stopped taking Simvastatin and a lot of the pain has eased (unless I do something a little taxing), My memory and physical stamina however are still so easily depleted, I hope that many more people learn about Statin side effects by reading the article and posts on sites like this and not by having to live with them through Statin therapy like we all did.

Great link Lars and thanks for posting it

[lars999]

Allen,

Thanks for your comments. They should help orient a lot of new and casual visitors to this site.

Perhaps the one point I like best from that NEJM article is the clear distinction between the VERY controlled drug testing designed to obtain FDA, etc. approval to market the drug and the really rather uncontrolled, real world "testing" that happens when a drug is approved and then given to the widest possible range of persons. Statins have got to be one of the best examples of essentially uncontrolled use of a FDA approved drug. There simply does not exist a well researched set of criteria for NOT PRESCRIBING STATINS to a person that will suffer debilitating adverse side effects. Couple that with all the excessively positive BS about statins and one really has some pretty egregious malpractice.

Or, to express it somewhat differently, from a different cultural perspective, "The customer is the Quality Assurance Agent." That perspective is from life in former Soviet Union in 1950s to at least early 2000s, if not until present. There as well as "here", it is Internet sites like this one that provide the inquisitive, determined and often desperate person a measure of self-protection, albeit, often too late.

Should anyone want to learn about some of the more inappropriate, knee-jerk uses of statins, do some Google searches on Dr. Per Langsjoen and/or his son Dr. Peter Langsjoen. Per was specialist in treating advanced heart congestion patients. Shortly after statins came to market, he found that he had to get them off statins before he could make progress in reversing their congestive heart failure. He was one of early whistle blowers about statins.

But, I suspect there are additional inappropriate uses of statins in actual practice (above and well beyond the stupidity of lowering cholesterol to unnatural and unhealthy levels). Of late I encounter more and more diabetic persons that have been prescribed a statin, "because diabetics have high risk of heart attacks". This in apparently total ignorance that there is at minimum a 16% additional risk of adverse consequences to severity of diabetes from statin drug use, not to mention all the non-diabetic adverse consequences you and I an most others here have come to know so well. We on this site would likely immediately presume that 16% is only the tip of iceberg.

Lars

[leeno]

Lars999 -
Thanks for referring the NEJM article. I HAVE COMMENTS!
1. Wonderful to see the NEJM take the plunge with statins. And we can be grateful to these researchers - I wonder who on earth paid for their work? Not the drug companies! But, on the other hand, these are just crumbs we are celebrating over. We are so far from having what we need and deserve, including addressing many of the issues mentioned in the article.
2. My favorite part of the article: "Given the lack of standard definitions and relevant biomarkers, we propose a simple definition of statin-intolerant patients as those in whom statin-associated adverse effects develop that are either recognized by a physician or [u]identified by the patient and who find their quality of life so diminished by these effects that they discontinue or modify their lipid-lowering regimen." [/u]
3. Lars, you're good with words and info. Why don't you draft a letter to NEJM, on behalf of all the Spacedoc Forum users, praising the editorial board for publishing this article? It probably won't get printed, but it could have an impact on the editorial board. I'll help.
4. Not specific to this article, but it triggers one of my pet peeves. The complete content of medical journals is some of the hardest information to find on the internet. In a way, the journals are just like the drug companies: it's all about the money!! I mean the journals don't even have to generate their own content; people are falling all over themselves to do it for them. The journals are surely a very profitable venture, given their subscription rates.

Carry on, good people.

[lars999]

leeno and everyone,

I like idea of letter to NEJM from posters on Spacedoc Forum. I would be willing to be "writing author", something I have done now and then.

There are logistical hurdles, as always, but perhaps a bit worse with this forum because there is no working Personal Messaging function. We have two basic options: 1) I or someone posts a first draft in a new thread and others comment and/or make suggested changes -- this would be the totally open and public path, and 2) one or more of us posts their email address and functions as coordinator for getting us in touch with each other off line to prepare such a letter. Actual path to completion would likely be combination of these two. I would expect this to result in an Open Letter sent to NEJM, and to be posted where ever we think appropriate.

My preference would be for some number of us to sign the letter, as well as provide some tallying of numbers of affected individuals that have/do utilize this Forum. I envision a short, few paragraphs, letter stating our support and why, accompanied by appendix of support information about numbers of affected individuals, type and severity of adverse side effects of statin drugs.

I have always been reluctant to post even my most public email address on any public BB. I will post it if there seems to be enough persons willing to participate.

There have been several prolific posters here, each with their own perspective and information. An effective letter should result. I would like to aim for a letter that could be published in NEJM as a supportive response to the cited article.

Feedback???
Lars

[leeno]

Great, Lars!
If you take this on, I, for one, trust you will do a fine job. So go at it any way you see fit and are comfortable with.
Linda