Friday, July 31, 2009

Academic Journals, or Advertising Journals?

Academic Journals, or Advertising Journals?
And how can we tell the difference?

The good news is that Elsevier, one of the handful of leading publishers of academic research journals, has the guts to go public with this issue.

The bad news is that there supposedly legit academic journals, publishing supposedly legit studies, supposedly authored by researchers of integrity, supposedly judged and reviewed by impartial academic reviewers, and these journals are nothing more than marketing publications paid for by pharmaceutical companies.

Here is the controversy: There is a publishing company called Elsevier, one of the most prominent academic publishers, with Lancet as their lead journal. In this past year or so, someone figured out that Elsevier was coming out with a slew of journals called "Australasian Journal of [Fill in the Blank], and that these journals were basically funded by a specific pharmaceutical company to promote one of their specific patented drugs.

The lead example has been the Australasian Journal of Bone and Joint Medicine. Rather than sharing the latest evidence and outcomes, it emerged in court proceedings that the journal was bankrolled by Merck to promote rofecoxib, Merck's big-dollar pain medication marketed as Vioxx until lawsuits exposed the heart health risks from Vioxx.

So, while bone and joint docs in Australasia, and the rest of the world, believed that they were reading decent, selected, reviewed, vetted studies regarding rofecoxib/Vioxx and other treatments, they were actually reading a disguised advertising brochure.

Furthermore, Merck's pharmaceutical representatives were visiting docs across the world, and updating the docs on the latest "empirical" research. The drug rep could hand the doc a seemingly impartial, scientific article supposedly providing an impartial assessment of various medications for various pain conditions.

Investigation revealed that the publishing company, Elsevier, had several of these fake journals.
This issue progressed. To save their actual, legit, premier reputation and position, Elsevier jumped into action to squelch this practice.

First, they explained away these fake journals as being part of a rogue division operating all over Australasia with little supervision from the parent company.
Next, they declared that they would get rid of all of these journals.

To the credit of Elsevier, this August brings the publication of a commentary letter in Elsevier's premier journal, Lancet.

Australian researchers Jureidini and Clothier sublitted a letter, titled "Elsevier should divest itself of either its medical publishing or pharmaceutical services division.
what the letter strikes at is the issue that Elsevier develops twto types of publications: impartial scientific journals, and pseudojournals that are thinly veiled marketing pieces. The authors note, regarding Elsevier's pharma-promoting pubs masquerading as education, that "education is a euphamism for marketing."

Lancet published this bold, accusatory letter. This deserves a lot of admiration. However, Lancet/Elsevier follows up with a response that falls flat. They stand by their pharma-funded, pharma-promoted efforts to provide publications that appear as though they are impartial science, but are designed to "help pharmaceutical companies publish and market their research."
The advanced level of transparency, and acknowledgement of the issue, is progress in the issue of conflict of interest. Hopefully this trend will continue, and will snowball. We, and our physicians, need to be able to tell when we are reading an impartial, peer-reviewed journals, and we, and our physicians, need to be able to know when we are being presented with a piece of paper that is nothing more than advertising copy.

That only makes sense. The efforts now underway with Elsevier will correct these specific issues. But it takes a lot more to rebuild trust between consumers of research and publishers. It is very likely that as people recognize the gravity of this problem, trust for peer-reviewed medical journals in general will be damaged.

Monday, July 27, 2009

SSRIs again? "Man Kills Wife, Grandson, Himself on Wedding Anniversary"

AP story: Man Kills Wife, Grandson, Himself on Wedding Anniversary

I just saw this terrible headline. Terrible. I can almost guarantee that antidepressants wre involved in yet another familicide-suicide.

George Doby. Atlanta. july 27, 2009.

Google the headline to find the story. I don't think the link will persist.

Married to the same woman for 57 years? That does not sound like a foolish person or a mentally unstable person. Or a "cheat." Or a "drug addict."

"Dobys were a close-knit family that often got together for Sunday dinner." We are talkign about someone with social support his entire life? Shoots ppl all-of-a-sudden? How long do you have to be a decent person to be judged a reasonably decent person? I judge that this man was a reasonably decent person, from whom we would NEVER expect this type of thing. In contrast, I bet he was the opposite: giving, self-sacrificing, helpful, controlled, supportive.

Shoots his grandson? Who shoots their grandson?

If anyone catches more in-depth info, please post a note about it here.

If antidepressants have a bad effect in some modest portion of our population, towrd violent aggression rather than toward benefit, we need to keep briging this issue up until these drugs are only used in a certain way - with full fair warning for the patient, and a warning to involved family members.

Plus, research dollars need to be diverted from studying yet another me-too drug, to studying who gets affected this way, and how it happens physiologically.

In other posts, I have noted my opinion: maybe 3-4 % of people get this effect from SSRI and SNRI, or withdrawal from these, and I suspect it somehow involves the role of the neurotransmitter nitric oxide upon the frontal lobes of the brain.

I believe that for a modest portion of people, these drugs lead to a change in frontal lobe nitric oxide balance that loosens our normal capacity to govern thoughts or feelings of aggressiveness. I believe this effect is profound enough to strongly contribute to a family man killing self and family. We know that people who get frontal lobe head injury damage are more aggressive. The drugs are just messing up the frontal lobe functioning though chemistry, not blunt trauma.

Enough people have died now for us to take this seriously. Check out ssri-stories.com for more info.

Sunday, July 26, 2009

Bad timing: NEJM: Obama’a top-down healthcare quality plan not working in UK

Bad timing: NEJM: Obama’a top-down healthcare quality plan not working in UK

The article is: Stephen M. Campbell, David Reeves, Evangelos Kontopantelis, Bonnie Sibbald, Martin Roland. Effects of Pay for Performance on the Quality of Primary Care in England. New England Journal of Medicine, volume 361, number 4, pages 368 to 378, July 23, 2009.

In UK, where they have had socialized health care for decades, the recent years have seen grand, extensive "pay-for-performance" plans. In a typical “P4P” plan, a doctor gets a bonu$ from the govt if he or she delivers certain clinical activities with patients, if that activity is warranted. An example would be: do you get all women over the age of 40 to have a mammogram every other year? Do you get all men in a certain age range to have colonoscopy as recommended? Do you ask each and every patient whether they smoke?

England has integrated a lengthy list of these incentives into their physician pay scheme in order to achieve great quality and manage costs. The whole concept is that if illnesses can be prevented or detected early, costs to treat those illnesses will be decreased. Remember: all the docs work for the govt, and he who has the gold makes the rules. So, the govt gets to decide how to pay docs, and by incentives, directs what the docs will do.

This current NEJM study does not achieve the optimal goal of connecting the incentives to the desired long-term outcomes. For the mammogram example, the long-term outcome would be the early, versus late, detection of breast cancer, AND prompt treatment once detected. The outcome would be: lower five-year mortality rates from breast cancer.

This study has more easily measured outcomes: does the P4P incentives actually end up driving docs to perform the desired behaviors? The results show that, yes, to some degree. But, it seems that the docs improve to some degree, then top out before reaching 100% compliance. Plus, the docs may increase these activities but at the same time do less of other things they should be doing. AS this study notes has happened for cardiovascular care.

It only makes sense. A doc can only do so much in a given span of time. Something has to “give.” The law of unintended consequences is operating.

This is where we in the U.S. are headed if we put a community organizer and his friends in charge of how docs get paid. Obamedicine. When you incentivize something, something else somewhere else will be compromised. To get optimal medical care, you would have to pay a “bonu$” for each and every little thing under the sun that the doc should do.

Never mind what you the patient actually went to the doc toge thelp with. You will be spending your visit answering a big range of questions and going through a range of screening activities each vist, so the docs can piecemeal their salary together.

People note that a big difference between the U.S. healthcare system and other healthcare systems is the “overhead:” paperwork, claims certification, etc. Sure, it would be great to see a system where the capitalist system is subverted and paperwork costs are dropped. But this NEJM study, exposing the weak results from UK’s experience, suggests how much micro-management, bureaucracy, documentation, and paperwork would be needed to adjust docs to perform “optimal” behavior.

Upon scanning this article, I don’t see how such extensive oversight will yield the suggested savings. My guess is that we will have an equal or geater level of "overhead."

We need to use this evidence as it comes out of UK’s extensive years of top-down management before we decide if we want to adopt their plan. For that reason, this NEJM article is very valuable and needs to be digested well.

So, let's take some time before we vote for this 1,000+ page health care reform plan that no one has yet read. [BTW: FWIW: I heard, to be "green," it was printed on the flip-side of the sheets of paper used to print the 1,000+ page TARP.]

Friday, July 24, 2009

Special JAMA edition on mental health! coming May 2010!!!

Get ready! Special JAMA edition on mental health! coming May 2010!!!

With all of the garbage parading as mental health research that has been published in JAMA, including the Robinson post-stroke paper which has actually climbed into the "infamous" category, I can only wait with baited breath to see how the pharma puppets spin their med solutions this time.

JAMA's call for papers, written by Richard Glass, notes: "All submitted manuscripts will undergo JAMA's usual rigorous editorial evaluation and review."

Is that supposed to be taken seriously?

JAMA has been hit hard regarding Robinson and other shams, and all they have done is defensively hit back, inclusing name-calling, rather than acknowledge the gaping holes in the fabric of editorial credulity. My recent observations:

http://www.medsvstherapy.com/2008/07/license-please-or-what-happened-to.html
http://www.medsvstherapy.com/2008/07/adhd-treatment-placebo-versusplacebo.html
http://www.medsvstherapy.com/2009_03_01_archive.html
http://www.medsvstherapy.com/2009/03/march-20-more-jama-backpedaling-on-coi.html

A decade ago, here is what Glass concluded after conducting a systematic review of medical research journal policies regarding conflicts of interest:

"Conclusions: Most medical, biology, and economics journals have not developed written policies to deal with conflicts of interest. Publication of substantive articles authored by the chief editor of the journal raises questions about conflicts of interest in oversight of the peer review and manuscript acceptance processes."
(Google any of those phrases or the title, "A SURVEY OF JOURNAL CONFLICT OF INTEREST POLICIES," to find the original.)

Glass has written a great deal regarding COI, and hopefully he will be able to police this upcoming special edition for any funny business. I have one article in development that will qualify. Right on the timeline. A review of evidence. The conclusion will be: therapy wins.

Monday, July 6, 2009

FDA sez: Side Effects of 2 Antidepressant Meds: Depression and Suicide

AP story July 1:
"NEW YORK - The Food and Drug Administration will require two smoking-cessation drugs, Chantix and Zyban, to carry the agency’s strongest safety warning over side effects including depression and suicidal thoughts.
The new requirement, called a “Black Box” warning, is based on reports of people experiencing unusual changes in behavior, becoming depressed, or having suicidal thoughts while taking the drugs.
The antidepressant Wellbutrin, which has the same active ingredient as GlaxoSmithKline PLC’s Zyban, already carries such a warning."

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm170356.htm

Does this seem odd to anyone except me?

Technically, Chantix is not an "antidepressant." It seems to have simialr effect in the brain as the various antidepressants associated with aggressive impulsiveness, including suicidality and homicidality.

Zyban is the same as Wellbutrin, an antidepressant. Just re-labeled.

Antidepressant studies were being conducted for bupropion, the generic name of Wellbutrin and Zyban. Some of the depressed study participants happened to report that their desire for tobacco smoking, and their saitisfaction from smoking, were decreased as a side effect of the bupropion. So, bupropion began to get attention as a smoking cessation aid. This led to FDA approval for an antidepressant as a smoking cessation aid.

There is nothing different or unusual about Zyban. It just happpens to help some people quit smoking.

At the same time, it opens the door for millions to be exposed to the side effects of depression and suicidality. FDA has caught on to this, and so is reviewing the warning label.

Thursday, July 2, 2009

FDA monitoring of chantix leads to stronger suicide warning.

"FDA: Stop-smoking drugs Chantix, Zyban must carry suicide warning"
-USA Today.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170100.htm

Meds vs. therapy. Therapy wins this one. for the past several years, Pfizer has been marketing Chantix to help people stop smoking. It works for some. Yet, for some, it causes aggressive impulsiveness that can lead to homicide or suicide.

At the same time, we all know that millions of people have quit smoking without taking Chantix. There are more former-smokers out there than there are smokers. We all can simply ask amongst friends and family and discover people who were regular smokers, and who figured out a way to quit, without Chantix, and have stayed smoke-free for a week, a month, a year, 2 years, 10 years, 20 years, 30 years.

Some did it on their own. Some did it with some kind of help - maybe counseling based on motivational interviewing, maybe not. Maybe with the aid of hypnosis, maybe not. Maybe because laws changed, or prices increased, and the balance between pleasure and hassle shifted enough for them to finally quit. Maybe because illness appeared, and a doc told them to quit. Maybe they substituted candy, or nicotine-replacement gum, or the patch, or herbs, or vitamin E. There have been a great deal of resaerch studies showing that therapeutic interventions can increase the portion of smokers who succeed quitting, compared to solo attempts. But it is surely the minority of former smokers who quit with psychiatric drugs, such as Chantix.

But if Chantix helps, why not?

FDA is stepping up its suicidality warning level on Chantix, the stop-smoking drug - that happens to affect serotonin, as do the SSRIs and the SNRIs. Suicide in non-depressed people associated with this brain drug: time to start paying attention.

To understand what is really going on with a drug, you need a great amount of data. You can't make a decision based on the bad, or good, experience of one person, or of a few people. Scientifically, it takes trained epidemiologists to guide the rest of us as we try to interpret the informaiton coming out of various sources of data.

This is one of the challenges that has been involved when trying to detect the problem of suicidality caused by antidepressants - the tough part is that at the same time you have a population where suicidality will be present anyway. That population could be prescribed lollipops and you would notice some suicidality - thoughts, attempts, and actual suicides. This aspect is used by the psychiatrists and pharmaceutical companies to hide the signal that is coming through the noise.

Many physicians attribute suicidality to the depression, not to the drug. So, when suicidality happens, the physician does not go through the effort to send an "adverse event" report to the FDA.

However, with a stop-smoking drug, this confusion is not there. You have a smoking population, not a population of people who have suicidality as a symptom. Tragically, it may be the use of these antidepressants in non-depressed populations that makes the problem blatently clear enough for people to begin to act responsibly.

Cafepharma is a website where people involved with the pharmaceutical industry share and discuss issues realted to their business. They have a discussion board. when FDA started posting warnings about Chantix for smoking, bck in 2007, this was discussed by some of the people visiting the Cafepharma discussion boards. Along with a million other views, here are a couple posts that show the chantix-suicide problem. Keep in mind: these are generally pharma-positive people, and these are spontaneously posted remarks - they were not solicitied for a lawyer, for a documentary, to get disability benefits, etc.

"I wanted to post a Blog about my most recent experience with Chantix. My reason is that my doctor did not make me aware of the Suicide scare. I left my doc's office with a script for Chantix and no direction. Chantix worked very well for me. I quit smoking my third day on the medication. After 21 years. I was never able to double my dosage by day 7 to 1 mg. in morning and 1 at night due to extreme nausea and dizziness. I stayed at .5 morning .5 night. Had major dreams..which I liked..I could feel textures, smell, taste, feel heat and OMG what an imagination I must have. I had few problems associated with the whole stop smoking experience. Limited events of feeling over whelmed or Nicotine fits. Very few temtation moments after the first week. Everything went smooth some slight nausea till my 48th day on Chantix. Probably the best week of my life and I went to bed with an overwhelming feeling of wanting to kill myself. Like a driving voice telling me to. Like my thoughts were..OH GOD I CANT PAY THIS BILL..JUST SLICE MY WRISIT AND NO MORE WORRIES..I was hardcore..and lasted days..Some major meltdowns also durning that few days. The only thing that I think really saved me is my friend telling me of the news about suicides and murders associated with Chantix users..I thought that oh here someone goes raining on my parade. But I am glad because what little sanity I had left made me relize that it was the medicine talking. I stopped the night of my first vivid suicide thought. 48 days into half dosing of Chantix. It was a very scary experience, ruined my Holiday but I didnt jump off the bridge. I just wanted to post my feeling and experience hoping that someone might see the signs and relize it before it is to late.
I am still smoke free 61 days now. I owe it to Chantix it made it an almost painless experience..But I did feel some major effects in the end. Good luck to all on it.
Angel in Seattle"

Anonymous:"This is not a joke and I resent those on this board making suicide jokes or claiming that there is no validity to the Chantix-suicide link.
My father was happy, fulfilled, had a 1 year old granddaughter, great job making great money, no debt, beautiful house, and was retiring in a few years. He had no previous depression or psychological issues of any kind and no indication of suicide. Yet, 6 months ago, after taking Chantix for 2 months, he went into a field near his home and shot himself with a rifle. I lost my hero, my daughter lost her grandpa, my grandfather lost his son, my aunt lost her brother, and my husband lost his best friend.
How funny is it now? This is happening, and families are losing loved ones. Our family will never be the same. Maybe you should think before you write."

Those stories are chilling. If there is something going on, I want to know.

Darkly, some commentors joke that if a peson commits suicide, then they get counted in the portion of people no longer smoking. True. sick, but true.

--Sure, maybe the suicidality in these two anecdotes had nothing to do with Chantix. How to decide? Decent epidemiology. The FDA keeps getting these reports. but mainly, we need to have a general belief, amongst prescribers, that drugs, especially these serotonin-affecting drugs, affecting the brain can, in some cases, cause aggressive thoughts and impulsiveness. Then docs would report cases more frequently. And then could advise patients properly.

Each person receiving a prescription could be informed by the doc: "OK, this drug might help you quit smoking. However, for a small portion of people, maybe 3-5%, they experience thoughts of suicide or homicide, which have for some resulted in murder or suicide. so, if that occurs for you, stop the medication. If you feel like the urges for you get strong, call 911 or call my beeper."

Maybe, each person Rx chantix could be required to have a family member be informed so they could monitor this.

Maybe, at this point, a lot of people would redouble their efforts to quit without a psychaitric medication.

Most smokers have had a successful quit experience. All they need to do is repeat what worked before. They successfully quit with their own therapy, or were guided by some kind of therapy. Rarely have meds been responsible. The smoker has gotten back into smoking, and just needs to get back to what worked before. Easier said than done, but the fact remains that people quit without meds. Meds vs. therapy. Therapy wins this one.