Pharmalot... Pharmalittle... Good Morning

The article about the lawsuit against Chantix, settled out of court in favor of the claimant, is interesting in that he didn't commit suicide but only had suicidal thoughts. This highest-risk (of all the SSRI/SNRI drugs) in terms of suicide/homicide should be taken off the market.

And perhaps when President Obama's task force (post the Newtown school shootings) on mental health gets up and running - chaired by Secretaries Sibelius and Duncan - it will focus on the connection between school shootings and the SSRIs and somehow regulate the situation. Taking them off the market would certainly do it.

Barb, Chantix is not an SSRI.

The studies regarding a potential tie between SSRIs and violence have been done, and there is no discernable link.

http://www.ncbi.nlm.nih.gov/pubmed/11473500

http://www.ncbi.nlm.nih.gov/pubmed/22395429

http://www.ncbi.nlm.nih.gov/pubmed/21070110

http://www.ncbi.nlm.nih.gov/pubmed/20673556

http://www.ncbi.nlm.nih.gov/pubmed/15482629

@John2 - Re: Two of your cut and pastes - one was done in Ireland and the other in the Netherlands, not in a clinical trial setting, but reviewing some other kind of data in countries where the majority have a culture in common that was derived over centuries from a gene pool. The "melting pot" of USA is known to present a different challenge.

Three were studies (one in Australia) that added the use of SSRIs to see if it would either decrease impulsivity, alcohol induced domestic violence, and/or maladaptive behaviour in the intellectually challenged.

Something in USA is contributing to the increase in spontaneous and ever more deadly acts of random violence. Homeland Security consider the #1 threat to be economic disparity. Free SSRIs for everyone?

If those studies are correct, then why is there a warning for suicide on the label of the SSRIs? And are all those bizarre, frightening and ultimately sad articles in SSRI Stories just made up in someone's imagination?

Seems to me that the profession of psychiatry needs to examine its own culpability in prescribing these drugs so freely. It's not worth talking about pharma's culpability, or its cover-ups. Old news.

Barb, there is a warning for suicide in children and adolescents only. There is no warming about shooting up schoolyards or other acts of violence against others.

The bizarre, frightening and sad articles posted on SSRI stories are almost certainly not made up, but result from attribution bias. Heart attacks are more common in people who have are taking Lipitor, not because Lipitor causes heart attacks but because people with healthy circulatory systems are unliklely to be taking it.

Likewise, people with underlying mental illness are much more likely to be taking antidepressants than those without mental health issues. And if a member of my family committed suicide or went out and committed a violent act, I'd certainly rather blame it on the antidepressant they were taking than assume that that sort of behavior was something my family member was intrinsically capable of.

Who would want to believe their family member was capable of such a thing. Much more comforting to blame the drug, and maybe even let the facts adjust themselves a bit over time to make the attribution more plausible.

You are hiding your head in the sand.

Also the age at which the FDA deems SSRI/SNRI antidepressants a suicide danger to those who take them went up to "young adults"...I was there at the second hearing when this was a huge argument - many know that this age cutoff is arbitrary and meaningless.

Have you ever read any of Dr. David Healy's work? He is a world famous psychiatrist and psychpharmacologist and the author of many incicisive books. Might be worth your while before you weigh in on this topic again.

No Barb, I'm hiding my head in the data. You should try it sometime.

There is one warning. It's the Y chromosome. Only one of 62 mass murders in past 40 years done by a woman, in my own town, in fact. So let's forget about the girls in this regard and we can then devote 100% of attention to the other 50% of the schoolage population.

I had a meeting today with local university officials about drug use in that particular school. Warning signs aplenty, but stuff escalates and nobody intervenes when the warning signs start. Same with violence.

Best comment tonight on radio talk show. Caller says she has chronic mental illness, on a slew of SSRI's but never contemplated violence. She doesn't even like the term mental illness. She thinks the term is "insane".

There you go.

Against a mountain of evidence, Peter Dusenberg still insists that HIV is not the cause of AIDS. And if one searches long enough, one can find Professors of Natural History who believe that the world is 8000 years old. Likewise Healy chooses to ignore the vast body of data that is out there. What his motivations are I don't know.

Barb, my philosophy may be unusual, but I don't form strong opinions about the relative merits of the latest AMD and Intel processors and make opinionated statements about them on the internet. Why? Because I don't know a damn thing about processor design. For someone who didn't know Chantix wasn't an SSRI, I think you're coming on a little strong here.

Check out Pharmalot, 11/20/07, "Up In Smoke" Pfizer's Chantix & Suicidal Thoughts", but look out....there are a number of anecdotes in the 130 & comments. Also see Pharmalot, 2/1/08 Chantix & Suicide: The Latest Numbers"

Barb, Chantix isn't an SSRI.

Really though, how do you come to have such strong opinions about this? Other than the fact that you can buy it on Amazon, exactly what makes David Healy's book more credible to you than Marie-Thérèse Walsh'w comprehensive review of the clinical data? Did you find some methodological flaws in the studies that Dr. Walsh cited that you want to share with us?

If you don't have a good answer to those questions, its probably best not to have a strong opinion on the subject. Because strongly held opinions should be based on familiarity with the data.

How nice it must be to lecture me from the safety of your computer and your acronym. I could turn the tables and ask you questions as well. How can you so quickly dismiss David Healy, SSRI Stories, come up with your own "theory" of why all the suicides/homicides if not caused by these drugs, etc? Why are you such an apologist, why do you say the FDA put the warnings on the label, etc., etc.

But I shan't bother.

"Why all these homicides and suicides if not caused by these drugs"?. Lots of reasons for that, suicides and homicides have been with us throughout recorded history, SSRIs have not.

The problem with anecdotes is that each individual has a complex history, and attributing the "cause" of their behavior or health issues is impossible on an individual basis. Suppose David gets cancer at age 30. He doesn't smoke, eats few vegtables, takes a multivitamin daily, drinks too much, loves smoked salmon, served in Afganistan were he worked as a jet mechanic, has a grandmother who died of cancer, was exposed to a lot of pesticides as a child, and has a lot of sexual partners. What "caused" his cancer?

A bunch of guys who served in Afganistan and later got cancer could get together and form a blog, and say "well, we all got cancer and all served, so our military service must have caused our cancer". But if you do a study of 50,000 people who served in Afganistan and 50,000 who did not, and find identical cancer rates, that explanation has to be disregarded.

Healy is just not data driven. He draws broad conclusions based on his perceptions without having data to back it up. He attributes causation to non-statistically significant differences, and ignores parallel data that is inconsistent with his hypothesis. His study comparing mortality rates among schizoprenia patients today to those at the turn of the century is a nightmare of uncontrolled confounding variables.

And Barb, you started this discussion by suggesting that me and my colleagues are responsible for Sandy Hook and other mass shootings at schools. That's a pretty serious allegation.

If you're going to make provocative accusations like that, it hardly seems fair to role up in a ball and accuse me of bullying you because I point out that there is no data supporting your position.

I'll be blunt where John2 isn't. If an antidepressant restores productive lives to 999 people, and one boze decides to blow his head off, then I'll takes that risk benefit ratio any time, as will any sensible regulatory agency in the world.

Everybody thought that black box warnings would be the death knell for Big Pharma. Guess what. It's the rare drug that doesn't have them. I think the BBW's are good because we can all acknowledge them and then move on to the live saving benefits that the Pharma Gods bring to you all on a daily basis.

If some dude wants to turn himself into brain splatter I don't really give a crap.

There's a conference being held in Washington, DC, February 20-22 called "Selling Sickness s013 - People Over Profits"....if you live around there, it might behoove you to attend.

As for the SSRIs, you might want to read "The Myth of the Chemical Cure", by practicing psychiatrist Joanna Moncrieff, or "Crazy Like Us - The Globalization of the American Psyche", by Ethan Watters...the last chapter describes how pharma set about selling the concept of "depression" in Japan so that it could open up the market for the SSRIs.

Barb, there is inarguably a lot of unacceptable behavior in the pharmaceutical industry, just like in the oil industry, the chemicals industry, the banking industry, among real estate brokers, and among physicians. I don't disagree with you about that.

I appreciate your book references, but experience has taught me that such books are almost always written by someone who has an axe to grind. The outcome is always the same: Only those studies which promote the author's thesis are presented, and the results of those studies are often not presented accurately and completely. That's why I refer directly to the primary medical literature when I want to learn about something. Why put an ideologically motivated censor between myself and the data?

I'm quite familiar with the "selling sickness" arguments and don't agree with them. PLOS ran an article a few years back on how awful it was that Pfizer renamed "impotence" to Erectile Dysfunction. From my point of view, if changing the name of the disorder, which is usually due to physiological problems, makes it easier for men to talk to their doctors, there is no problem. What exactly is the harm in selling a $10 pill that allows couples to once again experience a full sex life, and how is that less moral than selling iPads?

"Restless Leg Syndrome" is another favorite of the "made up diseases" crowd. Again, the argument doesn't win me over. For 25 years beginning in high school, I fell asleep every night 3-5 hours after reaching a state of complete exhaustion due to RLS. At the time I didn't know these weird symptoms had a name or that anyone else in the world experienced anything like that. I started getting a decent nights sleep most nights for the first time since my teens when the advertisements for RLS drugs hit the airways in my 30s.

If you think the pharmaceutical industry is evil and a negative influence on society, I would challenge you to align your behavior with your beliefs and simply stop using our products. I think a week or two into your next bacterial infection, you'll agree that we bring considerable value into the world.

The Gates Foundation issues a press release regarding the progress of its partnership with major pharmaceutical companies to eliminate 10 key tropical diseases by 2020.

http://www.impatientoptimists.org/Posts/2013/01/Global-Partners-Start-Making-Good-on-Their-Promise-to-Fight-Neglected-Tropical-Diseases

But perhaps lymphatic filariasis, trachoma, soil transmitted helminthiases, onchocerciasis, schistosomiasis, leprosy, Guinea worm, visceral leishmaniasis, Chagas disease, and African trypanosomiasis are just additional examples of "sickness mongering" and another attempt to propagate Western disease concepts in order to sell more drugs?

Who knows, maybe people in equatorial Africa like having 24-36 inch worms eat their way out through their skin, and this is just another example of cultural imperialism.

Maybe you guys can discuss this issue at your conference.

@John2 - "...Who knows, maybe people in equatorial Africa like having 24-36 inch worms eat their way out through their skin, and this is just another example of cultural imperialism...."

You go so over the top that whoever you are and whatever you do to get paid by "pharma" comes under serious scrutiny by SCIENTISTS who are actually doing the work.

The writers of episode after episode of all the Star Trek TV dramas would be better picks for dealing with the ethics of "cultural imperialism" than your extremist examples that you trot out when you want to "win" a debate!

Scheesh.

Until you know at what level of competence the locals who have been living in the tropics with those health dangers are at

- meaning how aware are they of the threat and how have they, themselves, without cultural contamination, evolved some defense and security against the threat -

you can't just "sell" a cure, especially if you don't actually have one.

I don't know enough about what's going on at the locations to comment about where the locals are at in "warp" development. Microscopes have been around so long, I guess I'd start with determining why the locals are "pre-warp", or in this case, "pre-microscope", and proceed from there. Obviously, the indigenous threats have not wiped out the population's ability to increase its numbers, so they got something going on that deals with the threat(s).

And what are you going to trade with them in return for your post-warp medicine, so to speak, is where the valid discussion of "cultural imperialism" begins, no? How much do you care about the unintended consequences of polluting their cultural timeline with the economic protection the "west" provides for greed, avarice and self-serving "insane" ideology?

Good points, dieczko. The conference is not only about disease mongering, but that is certainly one of the topics.

Wish I could go - great presenters.

DZ, it has been pointed out to me by knowledgeable persons that everything pharma does is evil.

I'm just trying to be open minded and get my head around how one would rationalize the Gates-Pharma collaboration to eliminate tropical diseases within this paradigm.

Otherwise I'm just locked into the imperialistic, exploitative mindset that assumes that eliminating the Guinea worm with donated drugs would be a humanitarian act.

Please bear with me while I try to adopt a more enlightened world view.

@John2 - "...Please bear with me while I try to adopt a more enlightened world view...."

Well then, go to an internet Star Trek geek fan club site and ask them for all the episodes that deal with "Prime Directive" and health issues in pre-warp species. I'll send you the 7 bucks to buy a month's worth of Netflix.

WHatever you did so far and what you are doing now is getting you no where, and worse, you're losing credubility in thinking this is all jsut a debate to be won.

So DZ, is your position then that eliminating the Guinea worm would be bad for the citizens of Mali?

I'm grateful that I don't have to defend pharma. One would naievely think that prescription drugs were only developed to save people from dread diseases, help cure people of them, and so forth. But, sadly , one would be wrong. The history of the industry is rife with the development of so-called "blockbuster" drugs in which there is really little efficacy and a lot of "collateral damage" - people dead or their health impaired due to the effect of the drug. Psychiatric drugs are a real case in point.

Reading though this thread, it seems that john2 is trying to make an extreme case and it doesn't work.

The industry should be above reproach and unfortunately it's not. Greed is the name of the game, not what Eli Lilly would have you believe.

Suzanne,

This discussion started out with Barb asserting the SSRIs cause people to shoot up schoolyards. I presented several well designed, peer reviewed studies showing that SSRIs do not increase violence. Barb did not respond with any studies that support her position (There aren't any).

Being unable to support her position, Barb then moved into a general "Yeah, but pharma is really really evil" argument. I agreed that there were a lot of problems, but pointed out that there was a lot good going on too.

So what exactly is the "extreme viewpoint" you think I am advocating?

I'd also point out that both Barb and DZ appear to have taken the point of view that there is something immoral about donating drugs to help eliminate third world diseases. This seems like a pretty extreme position to me, and I think it would to you too given that your post suggests that improving human health should be the exclusive goal of the industry. I'd appreciate your thoughts on this.

@John2 - "...I’d also point out that both Barb and DZ appear to have taken the point of view that there is something immoral about donating drugs to help eliminate third world diseases...."

You have absolutely ZILTCH proof in anything I posted that that is, indeed, my point of view. Stop listening to your personal mystical channelor who claims to be able to read minds :-)

Only in your brain is your perception real and the only reason you made up such a LIE is because you want to have everyone believe that YOU stand on the superior moral high ground when you are standing in the most shallow end of the ethical pool.

I said there is a wrong way and a right way to introduce "medicine" into a culture that did not evolve it themselves. But you don't care about how to do it the right way because you just want a piece of the action - the rent $$$$ - the tithe to the empire...and you don't even care about whether it's really a cure that you are "selling".

DZ, I apologize, I genuinely misunderstood your Star Trek analogy.

But nonetheless, since we are talking exclusively about donated drugs, your accusation that pharma is seeking a "piece of the action" in its collaboration with the Gates Foundation is both inaccurate and seems to be an example of the sort of reflexive and irrational hostility toward pharma that I have been trying to address in this thread.

I don't see that either of them said what you say they did...as for hostility toward pharma, I have it, too. Though yes, many drugs have been, are, and will be lifesaving is true. However, the fact that it's estimated that 100,000 people per year die from the side effects of prescription drugs is a shocking figure - more than car accidents. The fact that the FDA is kept in a weakened state due to the influence of pharma lobby money is a fact. The fact that many doctors are on the pharma payroll and basically say what the industry wants is a fact. And the giant fines that continue to be levyied on the industry for various civil and criminal acts such as off-label marketing is a fact.

Once upon a time, I thought pharma was a totally noble entity, and continue to be shocked at how corrupt it really is. And the cynicism that I see on these threads from people within the industry adds to that shock.

"However, the fact that it’s estimated that 100,000 people per year die from the side effects of prescription drugs"

That sounds about right Suzann. AHRQ lists 2.1 million hospitalizations due to adverse effects of drugs in 2008. The problem is that the effects and adverse effects of drugs come as a bundle. And while the adverse effects are a significant healthcare burden, the overall risk/benefit ratio favors leaving them on the market.

According to AHRQ:

13% of these hospitalizations were due to corticosteroids used to treat autoimmune diseases such as rheumatoid arthritis and lupus. (Most of these are generic drugs on which pharma makes essentially no money).

12.5% were due to pain relievers, including opiates. I agree there is room for improvement here, though many of these patients are deliberate abusers who OD.

11.9% are anticancer agents. We all know how ugly chemo is, but most choose the additional few months of life provided in spite of the nasty side effects. A substantial fraction of these are generic drugs that pharma makes no money from, including most of the most toxic ones.

11.6% are anticoagulants, mainly the generic drug warfarin. Again, pharma is making no money here. Its an old drug which kills people on overdose, but overall clinical trials have shown that in the average patient, it extends life expectancy.

14% are other cardiovascular drugs. I don't know much of the details of these or what the specific issues are

6.1% are antibiotics. Generally these are not very nice compounds, but much nicer than an untreated bacterial infection. Again, the most commonly used ones are older drugs that are generic.

5.4% are CNS drugs.

So the question I would put to you is this: According to AHRQ, insulin (for example) leads to about 44,000 hospitalizations each year, and a about 2000 deaths. There are about 1 million Americans with Type 1 diabetes, all of whom will die if you remove insulin from the market to prevent the 2000 annual deaths from insulin overdose. As the FDA, what would you do?

The reason there are 100,000 deaths per year from side effects of prescription drugs is that drugs are not approved on the basis of safety, but on the basis of having a favorable risk/benefit ratio. Likewise, several tens of thousands of patients die during or in the aftermath of surgery each year. Banning surgery will not reduce the total number of deaths, nor will taking these drugs off the market.

It was foolish to believe pharma was noble. It is equally foolish to believe it is evil. Like capitalism itself, it is a deeply flawed system that somehow manages to do more good than harm. The situation is far too complex to summarize with a single word moral judgement.

@John2, "...But nonetheless, since we are talking exclusively about donated drugs, your accusation that pharma is seeking a “piece of the action” in its collaboration with the Gates Foundation is both inaccurate and seems to be an example of the sort of reflexive and irrational hostility toward pharma..."

You have got to be kidding me! LOL! Even the Gates Foundation will tell you that PURE ALTRUISM is not what is driving their campaign.

"Charity" is a one shot deal that happens when over 300,000 homes are gone after a hurricane. Sophisticated and well-ordered societies don't make a big deal about "charity". Stuff happens and it NEVER breaks the back of a decent society to help people left standing with nothing because it is a given that everyone will get back to being a contributing part of the society if they're not left to die standing in the freezing rain with their whole lives washed out to sea while a couple of miles away people are eating pizza and watching cartoons.

There is no permanent benefit to any society if medicine is given as "charity" because it can stop being given at a moment's notice - and then what?

Unlike you, John, I have DATA on the industry having worked in it for decades. Nothing reflexive or irrational at all - "...just the facts, Ma'am...". There are too many bona-fide criminals in positions of power, and that's a fact. It's basically been "enron-ed".

@John2, "The problem is that the effects and adverse effects of drugs come as a bundle. And while the adverse effects are a significant healthcare burden, the overall risk/benefit ratio favors leaving them on the market."

You act as if the current status is etched in stone, that there will never be any learning from the "risks" that WILL ultimately lower the risks! There's this thing called "Research and Development", John. Ever heard of it?

DZ, I think you are drinking too much coffee.

Suzann, I am most grateful that you don't have to defend Big Pharma either. Leave that to us heavyweights. Go do the dinner dishes or something less intellectually taxing.

How disappointing to continue to be demeaned and dismissed on this thread, though it certainly would not be the first time.

Yes, I guess it was naive of me to think that an industry which was supposed to be a noble and life-saving one would be full of charlatans out for the cash above all. When I read some of the internal documents (from Astra Zeneca and Eli Lilly) regarding decisions made from the top on down about the atypical antipsychotics, it made my hair stand on end, however. And then to see over time that not one individual has been prosecuted for behavior that is clearly criminal is just beyond me, in terms of the level of corporate malfeasance. You can talk about risk-benefit ratios all you want, but many of these serious and/or fatal side effects are entirely preventable - if the corporate chiefs were to come clean. But they don't.

Well Suzann, I made a real effort to have an honest, two-way exchange on the issues. I'm sorry we couldn't have that discussion.

I agree that the behavior at Lilly was horrific. But I don't think you improve the world by adopting the same tactics of making unsupported claims and changing the subject when those claims are challenged.

Truth comes from looking at the data with an open mind, letting that data form your opinions, and accepting complexity.

An excellent article from BioEthics International for those comfortable with shades of grey, on the FDA's decision to put a black box warning for suicidiality in children on antidepressants.

http://networkedblogs.com/zamN6

And, you, John, need to cut back on the cocktails at night since you wake up every morning repeating the same tired schtick that you did the day before - stuck in Groundhog Day.

A TV series was light years ahead of you back in the 70s, you really should attempt to put down some new neural connections - might ward off the Alzheimers that results from a life of lying.

Maybe true in the past about incriminating documents, Suzann, but us ignobles have wised up. Walk in to most senior executive's office and all you will find in the way of paper is their appointment book. Not a single scrap of incriminating paper. They don't do emails, memos and phones are routinely debugged. They meet on mountain top retreats that don't have wireless service. They never let their guard down.

Look what happened when Cosa Nostra got loose lips-they all went down with the ship. We won't ever let that happen again.

@John2 - Here you go - this one might give you *ideas* about how to extract that hasn't been tried yet - mountaintop pooha take notice:

http://www.youtube.com/watch?v=JVVFkx10igw

@oii - you know how it goes, one person's perception is that the info comes from a "snitch". The other person just considers it a PSA - Public Service Announcement.

With so many trials and billions in fines, seems we have something going on that is more akin to the Nuremberg Trials than "snitching".

Maybe so, but remember that there were a few acquittals.

Barb, as a professional service to you and the others on this thread I have finally been given the green light to take the wraps of a brand new SSRI from Hoffman Benelux. It is known as Ablixa (alipazone) and will soon be coming to a pharmacy near you.

Just click on the link to the website and you soon can be receiving the newsletter. Better yet, talk to your psychiatrist about Ablixa.

http://www.tryablixa.com/evaluation/

@oii - not just acquittals, but also great job offers.

Wait, are we still talking about WWII Nuremberg Trials or today's pharma CIA holders?

DZ, there's a fundamental difference between me on one hand, and you, Barb, and Suzann on the other.

I look at the data with an open mind, and then form an opinion. I've found that this saves me a lot of trouble relative to the opposite approach, forming an opinion that meets my emotional needs and then trying to cherry pick data to support it. In the latter case one inevitably ends up in the embarrassing situation of having some unpleasant person like myself point out all the data that one chose to ignore.

It also saves one the embarrassment of having to fall back on irrelevant ad hominem attacks like calling someone a "liar", or "shill", when one's arguments have been demolished by someone who, having selected their position based on an unbiased assessment of the data, is in an intrinsically stronger debating position.

@John2, "...DZ, there’s a fundamental difference between me on one hand, and you, Barb, and Suzann on the other...."

I don't assume to have such a complete profile of Barb and Suzann as you have concocted from the little that they have posted, but I do have enough to know that their actual industry experiences do not match my own. Nice try, but no cigar....

I have put in decades in the trenches collecting and analyzing the SCIENTIFIC DATA that is the sole responsibility of Big Pharma to collect. That's actually the real product of Big Pharma - the QUALITY of their DATA. Product used to be the result of the DATA - which is not how R&D operates anymore, is it? It's like every other business model - here's the packaging and the consumer who will want the Viagra - now go find a chemical that will squeeze into the risk/benefit ratio.

You accept a THEORY that is a mathematical model - a risk to benefit ratio. Which is about as far from "open mind" as it is humanely possible to get.

Actually Viagra was serendipity as it was being investigated for other reasons. At the same I was also investigating another vasodilator for late stage CHF and male patients were having erections as an AE. Thus the erections came first with Viagra. How to capitalize on them later became a marketing campaign. Pfizer was only following the advice of Rahm Emmanuel by never letting a good erection go to waste.

@oii - "...Pfizer was only following the advice of Rahm Emmanuel by never letting a good erection go to waste..."

whatta set up for a cheap shot - I'm not taking it, though...

lol

Imagine what surprising side effects we are going to get from social media like "treato"

As I previous Chantix user I commented quite frequently on its adverse affects, at least on me. My posts appeared mostly during 2008. Although I still believe Chantix is much more dangerous than the FDA currently ackowledges I do not wish to revisit that particular debate. Admittedly I only briefly scanned the above posts, but it was my Lay understanding that Chantix is both a partial dopamine agonist and antagonist and is classified as a designer drug. Granted, the effects of Chantix may mirror those of SSRI's, but certain studies state that violent agression and suicide are at least 18X higher than SSRI's.