Tuesday, June 10, 2008

Where’s the Money? Harvard, MGH, and Money Laundering’s Perfect Storm

It will take us some time to figure out what went wrong at MGH’s Department of Child Psychiatry, but we already have enough data to make some reasonable conjectures.

It’s clear that Dr. Biederman, Wilens, and Spencer did not disclose the majority of their drug company payments to Harvard University. Their motivations were unclear. In yesterday’s posting, I proposed a kind and gentle possibility—namely, that they made honest mistakes, and really believed that most of the payments were not relevant to their NIH grants. Most of those who commented yesterday did not find this explanation exactly…shall we say…convincing. They may well be right.

As I have read more about this scandal, I think the more likely explanation is that these doctors felt embarrassed about accepting so much drug company money. On some level, they likely made conscious decisions to hide these payments. If true, this is a serious ethical breach, and all three of them may be in bigger trouble professionally than I originally thought.

As I’ve gone through the list of payments posted publically in the Congressional Record (click here and then type “Biederman” in the search box), it’s clear that the majority of money received by these doctors did not come directly from drug companies, but indirectly from various third party companies. And this is likely the key to the mystery of why the doctors assumed they could ethically hide these payments.

As I described last year in this New York Times op-ed, much of the continuing medical education (CME) industry in the United States is a legalized money laundering operation. Rather than paying doctors directly to give accredited CME courses (which is illegal), drug companies pay third party companies to create the courses. The checks are actually written by the education company, but the ultimate source is clearly the sponsoring pharmaceutical company. The drug industry has gravitated to this form of marketing because they realize that doctors are more likely to believe information in CME courses than information from drug reps.

The Harvard scandal represents the perfect storm of this money laundering operation. It appears that the vast majority of the money eventually reported by the Harvard Trio, a combined $4.2 million over 7 years, was drug company money that was laundered and processed to seem like it wasn't drug company money. And this, I suspect, is why it was so easy for the doctors to rationalize not disclosing it.

The most glaring example comes from Dr. Wilens disclosures. Senator Grassley posted slightly more than a third of Wilens’ payments ($612,303 out of a total of $1.6 million). Only $69,915 of this (11%) came directly from drug companies. Most of the money ($542,388) came from various third pary companies, many, possibly all of which, are CME companies.

Here’s the breakdown of Wilens’ indirect drug company payments:

1. TVG (p
harmaceutical marketing company): $42,000

2. J.B. Ashtin (m
edical communication company): $14,500

3. Phase 5
(marketing research and strategy company): $194,250

4. Medlearning (m
edical education communication company): $70,000

(Here is an example of a CME newsletter Wilens wrote for Medlearning)


5. Promedix/Advanced Health Media (s
peaker program management): $163,750

6. Primedia (former administrator of MGH Psychiatry Academy CME programs
): $32,000

7. Veritas Institute for Medical Education (m
edical education communication company): $25,388

None of this "soft" money was reported in Wilens' forms.

As a sad post-script, the Physician Payments Sunshine Act, a financial transparency bill which is likely to be passed by Congress, would allow essentially all such soft money to go unreported, because of a CME exemption tacked on to appease the pharmaceutical industry. It's likely that companies are already making plans to funnel even more of their promotional money through these opaque third party companies.

And so it goes....




69 comments:

Gina Pera said...

Thank you for the analysis, Dr. Carlat. Very helpful.

I'm struck by this passage: "As I have read more about this scandal, I think the more likely explanation is that these doctors felt embarrassed about accepting so much drug company money. On some level, they likely made conscious decisions to hide these payments"

Perhaps that is the case--and deserves redress. But we cannot leave out one huge factor in this discussion: Many of these scientists have been MADE to feel ashamed, given the propaganda campaigns about these medications.

They are trying to balance their science with public credibility--a largely ignorant public and press, in these regards-- and I can't imagine how tough that is.

Americans are largely ignorant about brain disorders and the need for many of these medications. And too many people confuse "gotcha" with critical thinking and knowledge.

There also remain too many simple minds who, perhaps betraying their own self-serving, mingy natures, do not understand any motivation other than money. And, so they do not understand that researchers might have higher motives as well.

Why is it that we will pay fortunes to rock stars, athletes, CEOs, and the like, but we demand that our scientists--some of our leading minds who offer the promise of life-changing discoveries--must eke out but a modest living? Where is the logic in that?

These issues are not simple. They are massively complex.

Anonymous said...

The unvarnished truth. Good on ya, Dan.
Still, you ought to spend some time in sackcloth and ashes to make up for your last post.
Google Biederman and you will see that this is making headlines around the world.

Anonymous said...

@gina pera

So now it is the poor dear under-rewarded Opinion Leaders (of Psychiatry not Scientology) who are forced to use underhand means to get their rightful due and keep the wolf from the door.

I eagerly await the next installment...

Iowa Doc said...

Dr. Carlat, I hope that you will continue to get this message out to the general public. Educating the average person on the street will ultimately be the engine of change. It is doubtful that the medical community will make the necessary paradigm shifts unless there is growing public sentiment forcing them to change.

Like any effective political message, this should be conveyed in simple yet colorful terms. The $2000 toilet seat on the B-1 bomber was a great example. I hope that you can create sound bites for public consumption that raise awareness among average folk.

The payoffs described in your article are certainly going to provide more political fodder. At a time when many Americans are struggling to buy food and gas, how comforting it must be to them to know that their doctor is picking up an extra 100K or so by hawking overpriced drugs.

Anonymous said...

What do you think about the UCSF and Pfizer deal that was just made public today?

Iowa Doc said...

Gina: Actually, many Americans are just as offended by the salaries of rock stars, athletes, and CEOs...but that is a separate issue.

I don't think that anyone has a problem with scientists making a lot of money; at least I don't. But it is a different matter when practitioners responsible for making helath decisions allow their clinical judgment to be affected by financial gain.

If any doctor wants to work for Pharma full time, who could object? But don't pretend to be a real doctor when in fact you are only playing one on TV.

That said, I still believe that government should not mandate anything EXCEPT disclosure. Sunlight will cure all.

Sara said...

I appreciate your clarifying these issues; it really helps to explain what happened in this case. The bottom line though is that CME is a scandal right now -- a disgrace. It's laughable how little it really has to do with patients getting better, especially in psychiatry, but really the objective of all CME at this point seems to be to make people into patients and keep them as patients for as long as possible. How did the medical profession let itself get hijacked in this way? There needs to be some huge changes to correct this appalling situation.

And clinical research is also a disgrace -- those trials that Biederman and his colleagues are leading as described on clinicaltrials.gov make my stomach turn. Putting 4-6 year olds on Seroquel for 8 weeks? And not even stopping stimulants if they already happen to be on those? So what happens after 8 weeks, pray tell? Do you keep the kid on it with all the physical effects that will entail or do you stop it with all the rebound effects to behavior that ensue from withdrawal? Conducting an 8 week trial with a drug like Seroquel on such young children should be outlawed. And a 12 week trial of Lamictal on 6-17 year olds -- same thing. These kids are having their human rights violated. I kid you not. You do not take these drugs for a period of weeks and come away scot free. Not at all. It's frightening what's going on out there.

Anonymous said...

Gina Pera:
With all due respect, when did you decide to become a shill for Biederman and his ilk? Are you serious when you say that Biederman must "eke out but a modest living"? Huh? I sincerely doubt that Biederman and his corrupt comrades are but "modest" wage earners without pocketing Big Pharma's money! You should be ashamed for trying to excuse their fraud by this charade!

Supremacy Claus said...

It's a perfect of nothing but meaningless lawyer gotcha and left wing bias, by the media, by Dan, and by most of commenters.

If Dan will moderate comment, don't people think he should check the comments every 5 minutes. I feel frustrated if I have to wait longer than that to see my brilliant repartee published. Who else here gets frustrated having to wait for my brilliant repartee? Tell Dan to stop wasting time on whatever else he has to do. Nothing is more important than these comments.

DrL said...

@supremacyclaus
Can you please clarify:

Is concern for children restricted to the left wing in your opinion. How does the right wing reproduce exactly?

And what is this lawyer-gotcha cliche which appears in every one of your posts? Could it be that you are running out of rational arguments?

Supremacy Claus said...

DrL: If this paper work lapse lawyer gotcha resulted in harm to a child, specify the case. I still await a fact of harm from industry sponsorship. The entire farce is pretextual. Until harm is shown, the left ideologues are invited to "Shut your face," in the words of Clint Eastwood.

Again, the left wing extremist has personal remarks take the place of a fact. Why? No fact has supported the Left for the past century. The Left is factless.

Also, if I were Bierderman, I would reply, to Grassley, "Bug off, you insurance company hack, my consulting work is no one's business. And I am suing you for defamation, seeking to pierce your unjust Senatorial immunity used to bully a private party for crass, partisan political point scoring. Let the Supreme Court say, it will give bullies immunities. Let the Justices show themselves as the cult criminals they truly are."

Even if tossed out on first pleading, Grassley will have generated $1 million in legal defense costs for the Senate. Government does nothing well or cheaply. The leaders of the Senate will speak to him about the cost of his big mouth.

Supremacy Claus said...

Iowa Doc: Please post your income tax returns of the past seven years on this web site, including all 1099's. I would like to rummage through them to make sure your points in the Comments do not represent a conflict of interest, to verify your credibility, and to make sure none of your points are self-serving nor serve the interest of a payor. Also, do you think, my forensic accountant could not find dozens of tax code violations, even if your tax returns were prepared personally by the Commissioner of the Internal Revenue Service?

If you have a problem with that request, explain again why disclosure is necessary.

Disclosure is lawyer scam and an ancient cult enforcement technique. Stalin had a policy of self-criticism. Journalists went for it. As soon as they did, he shot them. One has a duty to resist tyranny and left wing bullying to protect clinical care.

drl said...

S Claus: you said
"Until harm is shown, the left ideologues are invited to "Shut your face," in the words of Clint Eastwood.

Again, the left wing extremist has personal remarks take the place of a fact. Why? No fact has supported the Left for the past century. The Left is factless."

I checked your blog. You are a lawyer not a physician.

1. You don't seem to get despite posting on this blog for many moons that physicians have to abide by *accepted* standards of care in clinical work and in research.

If I injected my child patients with saline a few times for no *accepted* reason it would in all probability cause no demonstrable harm - but you can be sure the credentialing and licensing bodies would not wait for the lawyers to prove harm before disciplining me.

2. You do not address the contravention of NIH regulations instituted to safeguard patients not physicians and their right to do as they wish with patients provided nonone can demonstrate harm.


3. Why don't you publish the
he names of all your clients and sources of income (drug corporations included) for the last 7 years and I would be happy to join Iowa Doc in disclosing mine.We can then be in a position to judge whether there is any conflict of interest in your virtually anonymous posts here.

Much of what you say here is personal invective couched as commentary (lawyer-gotcha actually).

The fact that you wait eagerly to comment and read responses indicates that this all a lawyer-gotcha game to you. I am not sure why Dr.Carlat publishes your every comment when many contain no real information at all just invective.


I would say that the left wing is in in lusty form right now, wouldn't you say? If 'factless' is the most awful thing the right wing can hurl at us I will sleep very well for many moons.

Daniel Carlat, M.D. said...

I err on the side of accepting comments, as long as there is no profanity. I reject posts which are only personal attacks with no comment of additional value to the debate. When I see a comment whose only point is to say, "You're a bad person," or "I hate you," I reject it. Obviously, it's a judgment call.

therapyfirst said...

hmmm, drl seems to echo my feelings. I know you have censored some things by SC in the past, but maybe he should be called on some of his less than flagrantly wrong commentary a bit more often.

I'm having the same issue at another blog site I have been commenting on of late, and I get the sense the blog owner is at least considering my concerns.

Have to say, a bit ironic I chose to stop attending here with gusto and this Biederman issue happens.

I still read though.

Gina Pera said...

Iowa doc wrote: "At a time when many Americans are struggling to buy food and gas, how comforting it must be to them to know that their doctor is picking up an extra 100K or so by hawking overpriced drugs."

Are you a psychiatist, Iowa doc?
Have you ever treated a child with bi-polar? Where did you find guidelines on such treatment? Which medications did you use?

Or did you blame the parents for failing the child and send them to a therapist? (As if they hadn't tried that before.)

Until you can answer any of these questions, you are really blowing smoke.

In fact, I have no heard ONE person in any of these blog comments show one shred of compassion for the people who actually suffer from the disorders that are immensely helped by these medications. No compassion at all.

Gina Pera said...

Iowa doc:

Who are you to assume that their clinical judgment is affected by financial gain?

Gina Pera said...

"I still await a fact of harm from industry sponsorship. The entire farce is pretextual. Until harm is shown, the left ideologues are invited to "Shut your face," in the words of Clint Eastwood."


Amen Brother Klaus!

But where are you getting this left-ideologue stuff? There are just as many closed minds, rigid thinkers, and disconnected neural pathways on the right as on the left. Just slightly different packaging.

Gina Pera said...

Oh, a stroke of brilliance from SK:

If I were Bierderman, I would reply, to Grassley, "Bug off, you insurance company hack, my consulting work is no one's business. And I am suing you for defamation, seeking to pierce your unjust Senatorial immunity used to bully a private party for crass, partisan political point scoring. Let the Supreme Court say, it will give bullies immunities. Let the Justices show themselves as the cult criminals they truly are."

EXACTLY. He should NOT back down to this politician and his vested interests. He should not grovel. He should ask him to babysit five children with untreated bi-polar.

You cannot accommodate bullies. You must stand up to them.

(And Iowa doc...please....you think you're like George Bush, able to look into Putin's soul by looking into his eyes? Except with Grassley, it's deciding he doesn't have pictures of Hitler on his office wall so he's a swell guy? That's the litmus test of someone with honest intentions?

Please tell me you aren't a psychiatrist, because if you're that easily fooled by appearances, I'm really gonna wish you're a podiatrist.

Supremacy Claus said...

DrL: Padner, I hope you were smiling when you called me a lawyer. I consider that profession to be a criminal cult enterprise, whose tyrannical hierarchy must hang.

You admit there has been no harm. You certainly specify no case of harm. Personal remarks show frustration in the traverse. I just enjoy the quiet victory in the debate that they represent.

Thank you.

The way it works is, first Beiderman promotes mood disorders in children. The drug companies gravitate to him and use him for their ends. It is not the other way around. He was wrong before any sponsored activity. He remained wrong after ongoing sponsorships. The over diagnosis of mood disorder is this decade's ridiculous embarrassment of the psychiatry profession. Psychiatry has never gone a decade without a huge jackass embarrassment. Most emanated from Ivy med schools. These self-serious schools are ridiculed around the nation.

Gina Pera said...

Oh, I'm crushed, Claus. Just when I thought there was a voice of clarity here (other than Daniel's). sniff.

As for this from you:
"The way it works is, first Beiderman promotes mood disorders in children. The drug companies gravitate to him and use him for their ends. It is not the other way around. He was wrong before any sponsored activity."

You would not be more wrong. You're just too smart to be that wrong.

The question to asking is WHY there is bi-polar in children. Not whether it is real. We cannot overlook the many physical changes in our environment over the past decade, and how they affect us physiologically, including genetic expression.

One factor that's appropriate here: losing omega 3s from our livestock as, presumably, Iowans and others looking to market their corn focused on feeding it to animals--and even got government subsidies.

When they stopped eating grass, not only did the animals get sick and require hormones, but they stopped eating a source of Omega-3s.

(In case you are unaware, omega-3 derived from fish oil can be helpful in mitigating bi-polar symptoms, but most likely not as helpful as the mother having plentiful stores as the fetus' neurological system is developing.)

Human life is complicated, folks. We can't afford scientific ignorance.

Gina Pera said...

Thank you for posting that link to Wilens' piece on ADHD and substance abuse, Daniel.

It should be required reading for every substance use counselor and every barbaric bariatric-bypass surgeon, who utterly fails to understand the role that the brain (especially an understimulated one) plays in any activity that is done to excess.

It boggles the mind to think of how many societal ills could be conquered if more docs learned about the brain and it's role in one's ability to initiate and maintain healthy habits.

A young man recently diagnosed with ADHD (after being treated for depression by psychiatrists for EIGHT YEARS--a common error) started taking stimulant medication.What he could not get over was that he lost his desire to smoke cigarettes--"Yeah, I quit, and I wasn't even trying."

Thank you, Dr. Wilens!

Gina Pera said...

For anyone who is interested in what Biederman and others might have to say on this -- despite plenty of flaky stuff at the beginning-- read this Boston Globe story:

http://tinyurl.com/23b79z

Please pay no mind to Diller. His sole purpose in life seems to be getting quoted as an ADHD naysayer.

excerpts:

Biederman's boss said he does not believe the money affects Biederman's judgment.

"I think a pharma person would not dare to tell Joe what to say," wrote Dr. Jerrold Rosenbaum , chief of psychiatry at Mass. General, in an e-mail. "And if they made that mistake, it would be only once. . . . For Joe, it is his ideas and mission that drive him, not the fees."

Biederman said he quickly discovered that drug companies were less interested in bipolar disorder than the more established ADHD. He and Wozniak, who did not respond to a request for an interview, struggled to get funding for research on bipolar children. "The more controversial a diagnosis is, the harder it is to get funding from conventional sources," he explained.

AND

Though Biederman acknowledges that distinguishing bipolar disorder from ordinary crankiness and flights of fancy in young children is challenging, he insists there is no ambiguity in the patients at his practice. "People have to wait a long time to see me or my colleagues. . . . It's not that somebody comes to me after their child has a temper tantrum. They do things for years that are dangerous. These are things that profoundly affect the child," said Biederman, putting them at risk of academic failure or even suicide.

Anonymous said...

Also gina, the article you are citing was written over a year. Bierdermans' bosses had no idea how much money was actually influencing his judgements. At that time Biederman failed to disclose that information.

DrL said...

Gina
Neither Biederman nor his boss get to decide whether his judgement is clouded by money and whether it is OK to breach regulations and then conceal that fact.

No more than I am permitted to decide what is a permissible blood alcohol level when I am driving on public highways. This is decided after careful deliberation, by bodies appointed by society for its own protection.

It does not make it any easier on me if my boss thought I had superior driving abilities and therefore should be allowed to drive with a higher alcohol level.

Compassion and contributions to the field are not the issue here and do not absolve unethical behavior.



S Claus
I don't get to demand proof that I have maimed somebody when the cops stop me for a DUI.

***

I feel compelled to write this for all the patients who may visit this blog. Physicians are well aware of this already - even if they sometimes act like they have forgotten the fundamental principles of our profession and pretend that we acquire a qualitatively different amygdala and superior cingulate gyrus along with our MD diploma.

Supremacy Claus said...

DrL: My good friend, I am going to help you overcome your left wing education indoctrination.

In the US, we have freedoms. One is the a two sided freedom, the freedom to speak, and the freedom to hear speech. In a dozen cases of settled law, the Supreme Court has held that the pre-chilling of speech based on its content violates the Free Speech Clause. Even if the speech is criminal (planning a crime) or defamatory (alleging a false fact about a person), it can only be punished after the utterance.

You may have been thinking of Iran, Venezuela, or Cuba, where speech is regulated before its utterance. Any regulation that even discourages speech based on content, is also unlawful. I claim that these pretextual, lawyer bad faith, gotchas on self-reporting forms are
unAmerican, violate the Free Speech Clause, and that their authors should be deported to Cuba, where they would be among their tyrannical left wing, America hater ilk.

Non-content based regulation is permissible. So for example, one may pass a regulation banning loudspeakers blaring from a sound truck, in a residential neighborhood, at 3 AM. One cannot ban the content of the blared speech ahead of time.

I hope that helped you fill in the information about our freedoms that you missed in your left wing biased education.

James M. La Rossa Jr. said...

I faintly recall Biederman explaining-away four cases of sudden death in children taking desipramine in the late '90s. His pro-drug defense when faced with the ultimate calamity was to point out, simply, that "X" children die of sudden death each year and that there was a statistical probability that these four desipramine - medicated children were part of that random group. His overall argument, which seemed very elegant at the time, was to question whether parents should "sacrifice a better today" by denying their children medication for the distant "possibility of a better tomorrow." Biederman said it more eloquently, of course, and his rationale calmed a lot of child psychiatrists at the time who were going (quite reasonably) batshit because of these sudden deaths.

I fear the huge increase in antipsychotic prescribing among children and adolescents won't end so neatly. It seems axiomatic at this point that when child diagnoses yo-yo from ADHD to mood and anxiety disorders and back again, we are witnessing a new, unnamed type of spectrum disorder of which the scientific literature is not keeping pace nor making much sense of.

Guys like Biederman have been around a long time, so if anyone deserves to get rich in trying to figure this out, he's as deserving a candidate as anyone. But I fear that he and his colleagues are rolling the dice and, perhaps, unwittingly making things worse. Kids continue to get sick and sicker at an alarmingly fast pace. (And I'm not hearing a lot of success stories out there, are you -- even in the face of all this expert marketing?)

My heart goes out to these patients and their parents, who are compelled to choose between ever more powerful psychoactive drugs to get their children through the next school year, or to their next birthday. It's frightening enough to drive one back to Church or Temple.

Gina Pera said...

Unfortunately, Anonymous, I had to go back a year to offer anything resembling Biederman's perspective.

So far we've heard from Grassley and his insurance company lobbyists, an anti-psychiatry reporter (Gardiner Harris), and NYT copy editors looking for a flashy headline above the fold.

What we lack are the FACTs. And even when we have those facts, there will still be gray area. Yes, the gray area that is so difficult for those with an overactive anterior cingulate gyrus or amygdala--and too-weak prefrontal cortex. Meaning, half this country.

We cannot afford knee-jerk reactions. Too much is at stake. Google the news headlines and see how the hucksters and sharks offering their "natural remedies" have jumped on this alleged story.

It's just too darn bad that the experts who really could weigh in intelligently on these issues are too busy actually doing their work. But I'm sure they'd have been happy to talk to Gardiner and Harris, so they didn't have to overly rely on Scientology shills.

Gina Pera said...

"My heart goes out to these patients and their parents, who are compelled to choose between ever more powerful psychoactive drugs to get their children through the next school year, or to their next birthday."

It's nice to hear there's some heart in the discussion. But I'm sorry; you simply don't understand the choice.

It's not about getting through the school year. It's about small children wanting to commit suicide--and some trying it--because they are so unhappy. And parents being at a loss as to what to do for these children.

And guess what, folks? Some of these babies are "unhappy" from birth--and it has NOTHING to do with parenting. And their unhappiness only deepens as they age.

So, please can we ever leave the hidebound psychoanalysts behind? Haven't they done enough harm?

Gina Pera said...

" (And I'm not hearing a lot of success stories out there, are you -- even in the face of all this expert marketing?) "

No, I'm not, either. Which is why I volunteer to educate the public about proper treatment protocols.

Because too many docs haven't gotten the memo and truly have their heads up their arses when it comes to prescribing. Where's the headline on that?

Most people whose lives have been decimated by untreated mental illness can't afford to pay out of pocket for the good docs, who refuse to let insurance companies dictate how much time they can spend with a patient. Where's the headline on that?

James M. La Rossa Jr. said...

Gina: Sounds as if you're pretty tightly wound about this posting, whigh I respect, though we can't always address the part of the debate that most interests you. As you have aptly noted, it's a widely ranging subject. And considering I've dedicated my professional life to publishing journals about psychopharmacology, making a reference to me as part of the "hidebound psychoanalysts," is, well, kinda funny.

Let's pick a point of agreement. That even with seven figure honoraria and eight figure marketing, there are "not a lot of success stories out there."

Instead of placing causation on "too many docs haven't gotten the memo and truly have their heads up their arses when it comes to prescribing," perhaps Biederman and colleagues have, quite simply, overreached. Which is what I was trying to gently imply by recounting the desipramine tragedy 10-years ago. Perhaps things won't end with just a few deaths this time. In absolute sincerity, I don't recall a debate where so much scientific muscle has resulted in such little patient progress. And while I have nothing but disdain for that squirrel-faced Grassley, I've been a contributing witness to enough psychiatric advances to say with some authority that I don't like what's going on here and that Carlat needs to keep pounding away at "Harvard, MGH, and Money Laundering's Perfect Storm." But, then, again, I'm in Los Angeles tonight rooting for the Celtics, so it just might not be my night. Regards, j.

Anonymous said...

Gina,

For the sake of this discussion, I think it is fair that people know exactly who you are affiliated with and what your biases are. You don't provide a link like some posters do in which people can easily check to see why they say what they do.

I am a person who is tapering off psych meds due to them causing numerous side effects, including hearing loss and several cognitive issues. In spite of being told I would need these meds for life, that is being proven to not be the case.

I am not affiliated with any organizations nor am I a scientologist. So when I post again on this blog, people will know exactly why I have made specific remarks.

I think people deserve to know what your background is.

AA

Gina Pera said...

James wrote: ""Perhaps Biederman and colleagues have, quite simply, overreached. Which is what I was trying to gently imply by recounting the desipramine tragedy 10-years ago. "

James, no offense, but how can you edit a psychopharmacology journal and still have this opinion?

Those "facts" you offer on the desipramine case are wrong. Do some research. In fact, some smart docs would argue that desipramine is probably still a better choice that some current-day medications. For one, because it offers 24-7 coverage. But docs who don't understand physiology become Nervous Nellies and scamper away at the merest hint of problem. (Especially when grandstanding docs like Nessen stick their big noses into areas that they do not understand.)

Guess what? Children who need these medications are often physically vulnerable in many other ways--not just their brains. A nervous system that doesn't develop properly affects the rest of the body. The brain is central command for the body, after all.

They are also often low in many nutrients, including magnesium, which makes them vulnerable to cardiovascular events. But do GPs or psychiatrists know about this? No. They do not.

Gina Pera said...

"For the sake of this discussion, I think it is fair that people know exactly who you are affiliated with and what your biases are. You don't provide a link like some posters do in which people can easily check to see why they say what they do."

That's pretty rich, Anonymous. You could Google my name and learn about me. But as for you, you don't even provide a name.

I'm affiliated with NO ONE. I take money from NO ONE. Hard to believe, eh?

When I learned a few years ago--when trying to help a close friend navigate the mental healthcare system--how screwed up things are, I earmarked five years of my life to try to make a difference in whatever way I could. I always thought about joining the Peace Corps, so this was my chance--without having to eat grubs.

And my focus has largely been studying these issues and trying to parse them for people who need solid information, who have been so utterly failed by the mental health profession.

So, dig all you want. You'll find no "dirt" on me. No self-serving motives. Only compassion and outrage at what passes for mental healthcare in this country--much less the rest of the world.

And, Anonymous, your comments on this issue have rung very familiar to me. So I'm glad you finally are out with it. They are common among those who have been failed by psychiatry--with the wrong medication(s) and no attention to physical issues that might mitigate medications' effectiveness.

So, my ulterior motive: helping people like you.

James M. La Rossa Jr. said...

Gina: There was a desipramine "scare" that was well publicized and addressed in the medical community and rattled the FDA. That is a fact. I am not arguing the pros or cons of the medication, just that Dr. B. was a calming influence throughout the incident. Some historical perspective might be helpful at times like these.

Currently, the medical literature does not support the widespread use of atypical antipsychotics, nor are there any guidelines available to help physicians in the prescribing of these drugs in the child and adolescent populations. (And no amount of sponsored or unsponsored CME seems to be helping.)

As I said, "I fear the huge increase in antipsychotic prescribing among children ... It seems axiomatic at this point that when child diagnoses yo-yo from ADHD to mood and anxiety disorders and back again, we are witnessing a new, unnamed type of spectrum disorder of which the scientific literature is not keeping pace nor making much sense of."

Those are my points. I am not debating the influence of low magnesium levels.

ps--why not provide a short background link about yourself so others stop questioning your motives? It's more efficient than expecting other readers to undertake a google search. Just a suggestion. j

Gina Pera said...

James,
I re-read your post re: desipramine and see I didn't read it carefully enough. Apologies. You must admit, though, the first 3/4 of that paragraph are rather inflammatory.

Why should I provide my credentials? Aren't words enough? Can't readers judge whether they have merit, without knowing first if I have a PhD? ) Why is no one else asked to validate or even reveal their credentials?

Okay, here's my website, for whatever purpose that serves.. If I'd posted it earlier, I'd be accused of self-promotion, because I've written a soon-to-be-published book. (A book I've spent 8 years writing, with no plans of going on Oprah, but merely so I can scale back on volunteer work and leave behind a solid information source.)

There's always someone eager to project their own mingy natures on whomever they want to attack. Why give them ammunition?

http://www.GinaPera.com

Stephany said...

James, as always walks in with the voice of reason, and compassion.

"Let's pick a point of agreement. That even with seven figure honoraria and eight figure marketing, there are "not a lot of success stories out there."

Exactly. I've lived this for a decade (and not to go off track to appease Gina, but yes, I've lived with this for a decade with my daughter) and there are not a lot of success stories out there, with regard to medicating children, over the last decade my daughter has suffered more from the drugs than from what (now no one really knows)is wrong. Leaving it wide open for brain damage discussion.

Thanks for your perspective James, and support.
Stephany

scientificintegrity said...

Daniel - This analysis of the issue, now that you appear to have thought about it a little further, is a big improvement on the report you gave previously.

However saddening something turns out to be it need facing, even if it takes a lot of time and thought to do so. It must be that much more difficult to come to terms with when the issue involves someone you know or knew.

James M. La Rossa Jr. said...

Gina: Of course your "words are enough," but you've done a service by providing attribution for yourself, which will keep the focus where you want it: on your words. Just for the record: I have been an unabashed believer in the advancement of psychopharmacology for my entire professional career, and I certainly am not anti-industry (in fact, I have benefited from industry largess as much as anyone). I think that Senator Grassley is grossly undereducated about medicine and shows little conscious about some of the real (and avoidable) harms his office has occasioned. And I certainly don't blame thoughtleaders like Joe Biederman for beating their drums. That is what they do and I have had enough interaction with them to know that they are not "talking heads" for pay. They do believe. So I listen. And I appreciate that the off-label prescribing of many drugs has led to more advances than I can count. What I am critical of is that the FDA and the ACCME have unwittingly created a sanctioned pipeline called CME, which neither physicians nor clinicians benefit and which has resulted -- in this instance -- in a premature belief that bipolar children may benefit from a class of drugs which is yet unproven. There is a lack of compelling published evidence in this instance. Yes -- this hits home for people like Stephany and I -- who are parents with very personal issues, which makes us vulnerable to claims of bias. We can take it. But make no mistake about it, there comes the proverbial point where the "rubber meets the road." And Carlat's exposure of what is really going on here -- which no one has denied to my knowledge -- shows that what has transpired is an overly ambitious construct that atypical
antipsychotics are effective in more bipolar children than has been scientifically quantified. And there is no blame here, but only the perception that we may be going about this the wrong way.

The recent NY Times article regarding our friends in Boston made me pause. All anyone can ask for in this case is that docs exhibit the good sense and circumspect, cautious attitude with which they were trained -- and not have a new therapy shoved down their throats. Yes, it is critically important that we hear from experts like Joe Biederman. We need to know what he thinks; he is on the front lines after all. Regards, j.

Gina Pera said...

James wrote: As I said, "I fear the huge increase in antipsychotic prescribing among children ... It seems axiomatic at this point that when child diagnoses yo-yo from ADHD to mood and anxiety disorders and back again, we are witnessing a new, unnamed type of spectrum disorder of which the scientific literature is not keeping pace nor making much sense of."

Welcome to the 21st Century, James. This is new ground. These are new breakthroughs, and we're not always going to get it right. But knowledgeable clinicians get it amazingly right if you're willing to look beyond abstractions and preconceptions.

Why don't you seem some of these out, instead of sticking to your theories. Why don't you talk to parents of children who have been helped? Would not suit cognitive dissonance?

You also say: "Those are my points. I am not debating the influence of low magnesium levels."

From your mocking tone, I take it you're unaware of the importance of magnesium in nerve condition and 300 other bodily processes. You and 90 percent of psychiatrists.

And until more psychiatrists learn that the brain is part of the body, we will keep having poor medication outcomes--and ignorant people will keep blaming the medication and everything else.

If only issues were so one-dimensional as some posters here would like.

Anonymous said...

Gina,

Thank you for mentioning your website and for not chastising me as I realized after I asked you, I could have googled your name.

I am curious, do you think there is any situation where someone with a mental health diagnosis shouldn't be medicated? This isn't a trick question by the way.

AA

Gina Pera said...

James- Our posts crossed. But I appreciate your delimiting your criticism/concern to this salient point:

"What I am critical of is that the FDA and the ACCME have unwittingly created a sanctioned pipeline called CME, which neither physicians nor clinicians benefit and which has resulted -- in this instance -- in a premature belief that bipolar children may benefit from a class of drugs which is yet unproven."

This stands out from the many mindless ranting-against-medication posts.

I'm not an expert in CME. I just know there are a lot of dumb-kluck docs out there who should never have graduated from medical school (or med school needs to change its focus from selecting for the rote learners and proceduralists).

Well-trained docs with critical-thinking skills should be able to parse the literature, use common sense, and not simply regurgitate whatever pharma feeds them at these pharma-fest luncheons.

As for all the other docs, well, their incompetence stretches across the medical landscape, with disastrous results for public health.

And the fact remains, these medications are helping some children who otherwise would be bereft. Where are the ethics in withholding aid from them?

Meanwhile, who is showing concern for what might be causing these disorders? The possible factors are too numerous to mention, with some of them overwhelmingly genetic, but many related to epigenetic factors that people of child-bearing age are just clueless about.

Just look at all the epidemic deficiencies in this country--iron, iodine, magnesium, calcium, omega-3s, etc. These deficiencies harm the developing fetus, and there are simply no good "after market" solutions. This is called Natural Law.

And, if I hear one more parent talk of getting this "vanity" ultrasound photos of their fetus, I will scream. We have no evidence that these ultrasounds don't harm the baby--because it's not been studied. And, don't get me started on the uncharted psychiatric birth defects from in vitro.

Open your thinking, folks, and examine larger factors.

j-sk said...

Daniel, thank you for your contribution here on the interview with Melody Petersen:
http://www.onpointradio.org/shows/2008/06/20080612_a_main.asp

An audio well worth a listen. Melody Petersen has done her work well. Picked the link up from a comment at pharmalot.

Gina Pera said...

AA asks:

I am curious, do you think there is any situation where someone with a mental health diagnosis shouldn't be medicated? This isn't a trick question by the way.

-----
Of course, AA! Medication is the last option--after proper nutrition, exercise, meditation, community, connection, prayer, therapy, and whatever options the person might want to pursue.

I came reluctantly to seeing these drugs as miracle-workers. My mother's seven children never even saw an aspirin. We didn't even need eyeglasses.

I came to it after reading the scientific evidence, but more importantly, listening with compassion to people who have tried everything--sometimes for decades--and found nothing helpful. People who were convinced their "characters" were too badly flawed to change. People whose problems have been exacerbated by science-phobic therapists and by a culture who tells them to just buck up. It's inhumane.

We wouldn't do this with any other organ--e.g. try to "talk" someone out of asthma. Oh, wait, some shrinks used to blame that on the mother, too, and tie it to childhood fears.

It's absolutely insane to keep applying the psychodynamic paradigm to every "behavioral" challenge.

Now AA, do you see any situations were medication is acceptable? :-)

Anonymous said...

Touche Gina.

Yes, to answer your question as I saw it as an acceptable situation in my case. Unfortunately, the cure became worse than the disease as I developed a hearing loss and my LD issues greatly worsened from years on ADs and a stimulant. As a result, I am slowly (the key word here) tapering my meds and doing much better.

Like the experiences of people you reported, initially, I thought the meds were miracle workers. No disrespect to your position but to be honest, I wish my therapists had been science phobic as I was having horrible side effects when I was in therapy. I am not saying that as blame but simply as wishful thinking.

By the way, I don't think it was a case of having a bad psychiatrist. Even if geniuses don't have good tools, they aren't going to be able to help people.

I am not opposed anyone taking meds as long as they are fully informed of the risks. I don't expect doctors to report every side effect known to mankind. But I just feel they prescribe meds like candy and aren't always as forthcoming about the downsides.

On a different note, I didn't know that asthma was blamed on the parents. I thought was autism. Learn something every day.

AA

James M. La Rossa Jr. said...

Dear AA: In reviewing a new drug application, the FDA looks carefully at a number of areas in order to determine whether the agent will contribute to patient well-being. One of those areas, as you can guess, is the severity of potential side effects. By and large, the newer generations of a drug class show fewer serious side effects in clinical trials. That is one of the reasons for the drug approval, so, have faith.

What's especially curious to me is that drug failure due to side effect-triggered non-compliance does not vary to a high degree according to how sick you are. Logic would dictate that the sicker you are, the more willing you would be to "fight" through side effects in order to find relief, but that is not always the case, according to psychiatrists. For example, I find it fascinating that someone with major depressive disorder -- who is (presumably) too ill to engage in sex -- will discontinue a drug which lifts their symptoms, but may reduce their newly activated libido. So, one wonders ... do side effects become more pronounced as the psychiatric symptomology lessens?

My point (long-winded though it might be) is that, perhaps, the side effects you were feeling became more pronounced as your psychiatrist helped you work through some problems, so the contrast between how YOU felt and how the drugs made you feel, became more obvious. At any rate, I'm glad you're feeling better.

Fight it though they may, people who suffer from psychiatric illness deserve to feel the best they can over the course of their lifetimes. For a large percentage of those people, drug therapy is integral to "getting better." In following, the management of side effects is both art and science -- a chicken or egg dilemma if you will -- which must be enormously challenging for clinicians. In my case, I would rather have an arm amputated than suffer through acute schizophrenia, so discontinuing an effective medication due to anything other than a life threatening side effect confounds me. Regards, j

Gina Pera said...

AA-
This isn't a discussion forum on meds, but since you presented it, I'd bet good money your psychiatrist was inexpert. Because 90 percent of them (roughly) are, in my experience.

Not only do they disregard other healthy factors (as I mentioned before), but they also don't understand medications' effect on the body. For example, some SSRIs can deplete B vitamins (critical for a healthy nervous system) or that they can back-suppress dopamine in parts of the brain (and vice versa with the dopamine reuptake inhibitors). And, when you treat women, you can't overlook hormones or thyroid function.

That's why I do this volunteer work, because I grew tired of hearing abysmal medication stories.

My feeling is that too many docs are simply not accountable. They are alone in a room with a patient (a "mental patient" who will often doubt their own perceptions before the doctor's). And, let's face it, some of these docs are a few neurons short of a neural pathway. Sorry, but they just are.

No, I'm not asking for the impossible, because I know many excellent docs who do "get it." But insurance companies won't pay for them.

I really do think that experiences like yours are fueling this whole uproar over the MPH Three. And, that's a tragedy.

Gina Pera said...

James wrote: I would rather have an arm amputated than suffer through acute schizophrenia, so discontinuing an effective medication due to anything other than a life threatening side effect confounds me.
---

It's called agnosognosia, James--from the Greek for "not knowing an illness." Specifically, not knowing one has an illness. They don't connect the dots. They really think it's everyone else who has the problem. Everyone is just trying to stifle their creativity, their brilliance.

Which is why it's dangerous to give this perspective too much weight in the medication debate. A real sticky issue.

Gina Pera said...

P.S. AA mentions:
Unfortunately, the cure became worse than the disease as I developed a hearing loss and my LD issues greatly worsened from years on ADs and a stimulant.

--
I'm not a doc, but knowing a bit about ADHD, I see a red flag when you say that your hearing and LD issues (both could be related to dopamine) got worse on the ADs.

Also, but if you have ADHD, it often worsens for women around menopause. Estrogen being a precursor for various brain chemicals.

You might want to check out the National Center for Women and Girls with ADHD, founded by two pioneers in this field, physician Patricia Quinn and psychologist Kathleen Nadeau. http://www.ncgiadd.org/

I just noticed that their bookstore is offering many useful white papers on female-specific ADHD issues (that you won't find anywhere else).

good luck.
g

Stephany said...

"In my case, I would rather have an arm amputated than suffer through acute schizophrenia, so discontinuing an effective medication due to anything other than a life threatening side effect confounds me."-James
--
As a mother, I have embraced this concept/ and though it is horrifically difficult to become a bystander in your/a/child's life; sometimes it is what we know is right, working,etc.

Stephany

Anonymous said...

James,

I started off my post thinking we were having a reasonable discussion. But you have made it quite clear what your views are with your last point.

All I am going to say is that unless you know what it is like to have an arm amputated, you have no business making statements like that.

I greatly beg to differ about drugs being effective in treating mental illness. Check out the NIMH site on the success rate of antidepressants, which is 50% for a 50% reduction of symptoms. It is even less for complete remission.

Bob Whittaker, who started his research, believing in the miracle of neuroleptics, has found they are very ineffective. He has citations showing that people with schizophrenia do better without meds.

And a NY Time article on schizophrenia shows that doctors in Europe are finding that some patients can do great without meds.

One of the main reasons I feel that people like you think that drugs are the only solution is that professionals are clueless about tapering patients off of meds. They do it way too quickly and then confuse withdrawal problems with a return of the illness. This is one of my major complaints about the psychiatric profession.

When I told my psychiatrist I wanted to taper my meds at 10% of the current dose every 3 to 6 weeks, his complaint was that it was much too slow and I would never get off of them. My response was that by doing it my way, once I was off, I would stay off. Anyway, to his credit, he has been totally cooperative even if he doesn’t agree with my method.

Anyway, I could list several non drug alternative such as fish oil capsules which are backed by research. But I have the sense you are entrenched in your views and don’t want to listen. Otherwise you wouldn’t have made the statement that an arm amputation is an acceptable side effect.

I will conclude by saying that posts like yours make me so glad that I made the decision to taper off of meds and will be free of psychiatry in 2010 once I am done with my taper.

AA

Anonymous said...

James, I apologize for my previous post. In retrospect, I realized I was a little too strong.

I am just very frustrated that psychiatry seems to see mental health as a either or situation with drugs when there is research showing that they shouldn't be doing this.

AA

G - I will respond to your posts but I am getting distracted from what I should be doing. I am sure you understand (smile).

James M. La Rossa Jr. said...

First and foremost, AA, I was paying a compliment to your psychiatrist -- suggesting that he or she may have contributed to your symptom abatement, which may have made the use of drugs (especially in light of the side effects you were suffering) unnecessary. Secondly, as a lifelong resident of NY City until fairly recently, I have seen my share of acute schizophrenics among the homeless, and in my visits to see authors working on the 19th floor at Bellevue. Crude as my example might have been, to even suggest that "people with schizophrenia do better without meds," is not a responsible statement. I'll follow Gina's lead from here on and refrain from turning this into a discussion forum on meds. May 2010 bring you the happiness you seek.

Anonymous said...

jl,

I think you have highlighted the problems with research today. Research is no longer based on science but rather logic. Logic tells us that SZ is such a horrible disease that someone would lose an arm rather than suffer the horrible effects of SZ or that someone would rather suffer sexual side effects than be depressed. It sounds all so logical. Research now has determined the human experience is now a disease called "agnosognosia". All for the purpose of selling medications. Logic has made millions of dollars for researchers and drug companies at the expense of the patients.

Logic is so rampart in research we no longer look at the data as it only clouds the science behind it. We reward researchers for making sense and not at the accuracy's of their data. The human experience isn't even researched because it just isn't logical. No one would pick sz over the side effects of medications. Surely people would rather not have sex than be depressed. It just makes so much sense.

A great example is Chantix. The new smoking cessation drug. Logic tells us that all smokers have a mental illness because quite frankly you have to be crazy to smoke. Its kinda a form of slow suicide. So when someone suffers a psychiatric side effect while on Chantix, its not to hard to blame the patient for the side effects. We don't even demand to see the evidence that these people were mentally ill because we all just assume, because its logical, that these people were mentally ill to begin with. Because of this logic Chantix is still being prescribed. It will stay on the market because it is logical for someone to choose a fast suicide (Chantix) over a a slow suicide (smoking). That's where our logic has gotten us.

Research has to change. We have to start looking at the science, the data. Just because you, the doctor, has determined losing an arm would be better
than suffering the effects of SZ doesn't mean your patient holds that same logic. Science, the data, tells us sz's do better in the long term unmedicated. Sure, that doesn't make scientist rich or sell medications, but it does help the patients.

Anonymous said...

OK I have read these posts and feel frustrated. I am in the mental health field. I am no Luddite. I think some of the miracle discoveries in psychiatry involve ECT for depression and Lithium for bipolar I disorder. Not to mention anti-psychotic medications for schizophrenia and related psychotic conditions. I marvel at how much human suffering has been alleviated as a result of these treatments.
But let's get real: This discussion is essentially about honesty and integrity in psychiatric research, particularly drug research. And the alliance between the drug industry and academic medicine (including psychiatry) is leading to terrible consequences that, left unchecked, will almost certainly undermine the credibility of the field. And that is why it is so important to come down hard on Biederman and others who practice "research" under the guise of what amounts to bribes by the drug companies. Sure, you will protest. But let us not forget what the New England Journal of Medicine uncovered earlier this year -- that when you look at ALL anti-depressant medication trials, they barely work better than placebo. And, in Great Britain, the research suggests it is basically a tie between the true drug effect and placebo. You would never know that from listening to the Pharm reps who populate my department and feed my psychiatry residents. Hell... these people have no shame -- they even have the gall to claim that their particular antidepressant is better than the competition and produce shoddy "research" articles published in journals bought and paid for by their particular company to prove their point! These issues have also been addressed in articles in the NY Times showing how DOCTORS are bought off and brainwashed into going around the country spouting falsehoods about the miraculous efficacy of their particular agents!
And the problem is not limited to anti-depressant medication. Recent INDEPENDENT research in this country and Great Britain indicate that the so-called new line or "atypical" (and expensive) agents are no better (and actually under perform) relative to the "old line" and less expensive medications, like Haldol. Ah... but the cry of Tardive Dyskinesia goes out; so you prefer diabetes instead? I work in a major academic medical center and I NEVER see Haldol prescribed anymore -- even for people who cannot afford the supposedly "superior" atypicals. If Psychiatry were truly interested in relieving human suffering, then the field should be backing the use of the more affordable agents, which may help medication compliance. But no --- the lure of drug money is too powerful. Our field is literally intoxicated with pharmaceutical industry money, with disingenuous effects.
Of course, the problem is not limited to Psychiatry – witness the recent contretemps over the failure of cholesterol meds to lower cholesterol and heart disease incidence. And what did the pharmaceutical industry do? Why, they took out full page ads in major newspapers and actually said, in effect, “ignore the research.” And why?” Because “clinical experience” has taught us that these drugs work! You have got to be kidding me! Anecdotal evidence now substitutes for empirical research when the research doesn’t support the myth? Hmmm…calling Gina Pera here: Doesn’t this sound like the psychoanalysts who asked us to trust them regarding their claims for “cures?”
And speaking of psychoanalysts or more serious trained psychodynamic clinicians. Frankly, there is still a lot to be gained from focusing on the motivational and often irrational bases of human behavior. Such a focus will never explain schizophrenia, dementia, bipolar I and ADD (at least when diagnosed in childhood). Sure, analytical theory claimed they could explain most of these conditions; and it is good they have been discredited. But biological psychiatry will suffer a similar fate if it continues to over reach. Human suffering, in all of its myriad manifestations, will never be reduced to a single (or a combination) of genes or aimless axons. We can scan all the brains we want, prescribe all the drugs we have, but we will never reach the Holy Grail that way. Try explaining conversion disorders from a “gene” perspective! Integrationist and translational research offers the only hope, in my humble opinion. And, yes, Gina Pera, I do think it matters, in the ultimate scheme of things, that how you were parented, and what environment you were raised in, interacts with biological givens (genes) to produce health or pathology. The neuroscientists and the psychologists need one another if we are to progress any further. We just need honest research.

Anonymous said...

The research states ECT is the most effective treatment for depression. Have You ever looked at the COI's of the main researchers for ECT? Tell me why in 2006 Harold Sackiem finally came out with actual studies showing substanial cognitive side effects from ECT? (Something patients have been stating for 60 years)-It couldn't have been because for the past couple years Sackeim has been working on "the new ECT", FEAST could it? Funny how all the sudden, now, with a new machine to sell, ECT causes cognitive damage. Psychiatry researchers are lining their pockets from both the drug makers and the device makers. It is absolutely disgusting.

Psychiatry better start cleaning house. You are losing crediability at a pretty fast pace right now.

Anonymous said...

James - I find it interesting that you want to give my psychiatrist all the credit for my recovery and none to me. By the way, in spite of dealing with my mother's death two months ago and unemployment, I am still going strong and this is is without therapy.

Anyway, psychiatrists don't do therapy, remember?

G - Regarding your comments, Remeron was the specific drug that caused my hearing loss before menopause. Recently, I messed up the dose (long story) and took more than I should have. Hearing worsened until I got back on the right amount. As I have reduced the dose, there has been improvement although I don't think it is 100%.

You are right about menopause worsening ADHD. But many people who didn't have menopause have complained about LD like side effects on these meds

Not that this makes for a scientific study but remember, no one is collecting the data on the long term effect of these meds.

I am through with psych meds and actually, any kind of meds. I joke with people that if for some example, my cholesterol becomes high, I will eat seaweed instead of taking meds.

AA

James M. La Rossa Jr. said...

I simply refuse to submit to the jaded theory that doctors prescribe medications for any other reason than they see good response in their individual patients. Period. My experience is that most responsible physicians take side effects from drugs very seriously. Sure, they will try the hot new drug, but if they do not receive positive patient feedback, no amount of free lunches will get them to push a drug that will tie-up their phone lines and clog their waiting rooms with sick, miserable patients.

A number of excellent anonymous posts preceded my own -- one of which addressed Chantix -- an excellent example for the sake of this discussion. As we know, 100 out of 100 smokers die of smoke-related illness. The immense cost to our society in continuing to engage in this destructive behavior is scientifically unquantifiable. Of the five people I know who have taken Chantix, all five quit smoking (luckily, without any suicidal ideation). Barring psychiatric side effects in higher numbers than published to date, why wouldn't you try Chantix to get every chronic smoker in your practice off cigarettes? This is not an issue of pharmaceutical marketing, but of quality of life and pure common sense. This is a case (to echo a past posting) where logic and science meet very nicely. And to ignore this smoking cessation agent because the manufacturer is poised to make a lot of money is, frankly, cutting off your patient's nose to spite his face. Not everyone has the willpower and fortitude to pail the butts, put on their sneakers, and hit the bricks for that 12-mile run that marks the end of their smoking days. That doesn't mean that we give up on them either.

Anonymous said...

James,

Here is link to a site about how a survey showed that doctors blow off complaints about statin side effects even though they have been documented.

http://tinyurl.com/3kbj4j

I don't think this happens always due to financial conflicts. But the patient still suffers in the end.

AA

Stephany said...

The double-edged sword I carry, is that I believe the public needs to be aware of the severe reactions people have had to medications; and I also know that one of the most dangerous antipsychotics on the market is the only one that allows my daughter freedom from locked down psych wards and her mind; though that is little solace considering quality of life (to some people)...I have to say when a child(grown adult age child in my situation) has been "missing" for 5 months and calls a parent(me for example)and remembers me...well this is why I enjoy this entire discussion.

Consider the topic a diamond, with many facets, and each point shines with equal significance.

Anonymous said...

Thats the problems James! The side effects associated with Chantix are being blamed on the patients, just as the psychotropic medications. We are not going to see studies of the adverse effects because non-smokers don't really care if smokers die while trying to quit smoking.

My understanding is there are no patient identifiers provided in an adverse side effect report and the drugs makers purposely excluded mental patients from the clinical trials. In their own press release they state something to the effect, they test their medications on the population they intend to service. They go on to say most smokers have mental illnesses. Just exactly who were they marketing this drug for?

This is an issue of marketing. They are taking a population of people already disliked by society and now calling them mentally ill (logical by the way) because of the side effects of the medications. Without patient identifiers and excluding people from their trials, they have absolutely no idea if only the mentally ill are suffering these side effects. This is easy money for the drug companies.

The number of serious adverse effects from this drug is astounding considering people could with the proper assistance quit on their own. Chantix has something less than a 35% success rate and that rate is only with a patient support method offered from the drug company. They don't even know the long term success rate for this drug. And that is only for a population of smokers who weren't considered mentally ill.

Some doctor is sitting someplace lining his pockets playing on societies dislike of smokers. Marketing at it's finest! It is so easy to use the "qualitity of life arguement" if you aren't the one who had a love one die or become disabled. But that cost to society isn't counted is it?

Stephany said...

The FAA banned pilots from using Chantix, due to recent reports of erratic behaviors and suicides by users of Chantix. For the FAA to take a move like that should give some pause to wonder what's up with this drug.

James M. La Rossa Jr. said...

I'm not at all sure that "blame" is the issue here. While scientists conducting clinical trials can try to randomize psychiatric patients, for example, from a population group, psychiatric illness occurs in roughly 2-3 percent of the population, so some of those folks are going to get in no matter how much the CRO's try to keep them out. About 20 years ago, Wellbutrin was pulled from the market after a statistically significant rate of seizure(s) was noted in patients taking the drug. Wellbutrin was allowed back on the market after warnings were issued and it was discovered that the incidence of seizures occurred in obese patients (more inclined to seizures due to their weight) who were enrolled in the original clinical trials. I think it is safe to say that Wellbutrin has helped a lot of people over the course of the last 15 years or so. So, I don't agree with your hard line, my Anonymous friend.

Nor am I familiar with any claims by Pfizer that "smokers are mentally ill." Suffice it to say that you'd not find support for such a statement in the DSM-IV. (Having lived in Rome for almost two years in the 1980s -- where virtually every human smokes(ed) -- I wouldn't diagnose everyone residing on the banks of the Tiber with mental illness.)

And while it's true that there are other effective ways to stop smoking other than Chantix, one cannot condemn the drug because "people could with the proper assistance quit on their own," as you say. NO, SOME PEOPLE CANNOT. Just like some people, Mr. Cruise, can't beat postpartum depression by going to Scientology class! Doctors need options for their patients. (And, yes, I would agree, "safe options.")

I am moving on to the more current CME debate at this point, but please email me at james@larossa.us if you feel compelled.

ps--Stephany, just saw your post as I was about to hit the publish button. I imagine that smoking is a big issue for people who fly for a living as they have absolutely no opportunity for a smoke break in the air. Coincidentally, one of the five people I know who stopped smoking after taking Chantix was a stewardess. Luckily for her, she stopped before the FAA made their rulling. Cheers, j.

Gina Pera said...

AA wrote-
G - Regarding your comments, Remeron was the specific drug that caused my hearing loss before menopause. Recently, I messed up the dose (long story) and took more than I should have. Hearing worsened until I got back on the right amount. As I have reduced the dose, there has been improvement although I don't think it is 100%.
--------
From what I hear, AA, Remeron has lots of side effects for most people. (But for some it's the only thing that works.)

I do know that many medications "use up" key vitamins and minerals and so supplementation is advised. Do 90 percent of prescribing docs know this? No. So, the medication gets the blame.

Re: hearing loss. If it's not dopamine-related (e.g. Remeron backsuppressing dopamine), I'd also look into nutrients associated with hearing loss (magnesium and B vitamins come to mind).

With many anti-depressants, it's advised to increase B-complex, so maybe Remeron is one of them. good luck.

Gina Pera said...

RE: Here is link to a site about how a survey showed that doctors blow off complaints about statin side effects even though they have been documented.

------
Oh, don't get me started about statins.

How many docs will recommend a simple B vitamin and magnesium supplementation before prescribing statins? Only the very few good ones.

But is this the drug company's fault that these docs are ignorant and never learned about nutrition in medical school?

Why is it the drugs are always blamed but not the prescribers?

Gina Pera said...

AA wrote: I am through with psych meds and actually, any kind of meds. I joke with people that if for some example, my cholesterol becomes high, I will eat seaweed instead of taking meds.

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Hey, that's no joke, AA. Seaweed is an excellent source of magnesium. And mag lowers total cholesterol and LDL and raises HDL

I think poor Tim Russert could have used a doc who understood the link between mineral deficiency and an enlarged heart, not to mention clots. He might still be alive.

We are a stupid stupid country when it comes to these things. All "stress tests" and cholesterol numbers--docs obsessed on getting down that number like it's their golf game--and no true knowledge of physiology.

My Italian mother was right: "Americani" don't know how to take care of their health.

Anonymous said...

G,

So seaweed has magnesium, huh? You keep teaching me good stuff. I do take it by the way so that is nice to know it helps with hearing loss. And I do take a B complex.

It sounds like we're not far off in agreeing about meds. Like you, I definitely think that the issue of drugs depleting nutrients is a very neglected issue.

For example, I will bet most people don't know that Co-Enzyme Q10 is depleted by tricyclics. As I am sure you are well aware, tricylclics have been implemented in heart trouble and Co-Enzyme Q10 helps heart function.

You make a fair point about whether we should be blaming the drugs instead of the doctors. What would side effects look like if people were taking adequate supplements? Something to think about.

I understand that Remeron may be the only drug that works for people. However, people need to understand that drugs cause hearing loss. When I researched the issue, I was stunned to find out that antibiotics can do this as well as even aspirin if the dose is hight enough.

Stephany, due to my mother having dementia before she died, I understand about recognition issues. So I do relate to your situation.

I have no doubt you made a fully informed decision about the med. I just want everyone to have the same rights.

AA

Stephany said...

AA,

I'm not quite sure what you are referencing with regard to the last comment you made, but if it is with regard to how I feel about my daughter on meds? I'd rather not have her take anything. Have I seen her come out of a 9 month psychosis on Clozaril? yes.

She is also a legal adult and makes this choice on her own, because she says she feels better on them; though what is happening is a recovery from a psychotic break which in essence is recovery from a TBI (traumatic brain injury).I do believe the brain has capability of healing, and she is proving that every day. (while on Clozaril).

Some people may disagree with my daughter being on medications, and that is simply no one's business but hers, and as James stated previously, he has witnessed just as I have the devastation of Schizophrenia, and there are drugs that are less than good, not tolerable, and this is where something has to be done to find a better path for recovery, on or off of medication, Schizophrenia is a tragic and isolating illness that robs people of lives, hope and dreams.
This is why I appreciate this forum, and James' support. As a consumer, and advocate and caregiver I've been able to learn from Carlat and the other professionals that write here from the frontlines, because until we can understand how this works, we cannot break it down and change things for good.

Back to the CME topic for me now.

Gina Pera said...

I realize this thread is dead, but today's NYTimes magazine story on children with bi-polar should be read by everyone who:

1. disbelieves that children can have bi-polar
2. disbelieves how severe it can be
3. believes that the MGH 3 witch-hunt, in which Gardiner Harris at the NYTimes was complicit, solely has to do with financial mismanagement/under-reporting.

My personal communications with Mr. Harris left me convinced that, bottom line, he doesn't "believe" that bi-polar can manifest in children. I hope he read the article.

http://www.nytimes.com/2008/09/14/magazine/14bipolar-t.html?pagewanted=1&_r=1&sq=jennifer%20egan&st=cse&scp=3

(If that link doesn't work, search on Nytimes.com for "The Bi-Polar Puzzle," by Jennifer Egan, on September 14, 2008)