Thursday, April 10, 2008

Drug-Rep Free Zone

I've had it. As of today, I am no longer allowing drug reps into my office.

Yes, until today, I was seeing reps a few times a month for 5 minute visits in order to keep up on trends in drug company marketing techniques. But today, an Astra Zeneca rep and his district manager came in to push Seroquel for bipolar depression. They came armed with the two studies that won Seroquel its FDA approval. The studies have their limitations, but somehow these reps didn't bring these up.

Instead, what I got was a ridiculous hard sell: "Dr. Carlat, given this data, would you choose Seroquel over the other atypical antipsychotics for bipolar depression?" I asked them if Astra Zeneca had done any head-to-head studies comparing Seroquel with the others. The rep adopted a pseudo-confused look, and said, "I'm not even sure that kind of study would be ethical--would the FDA even allow you to compare an approved drug with an unapproved drug?" I pointed out that the FDA, in fact, requires that drugs be compared with placebo, the ultimate in "unapproved" drugs, and that they deem this ethical enough.

He tried another tack. "What are the symptoms of bipolar depression that you have the hardest time treating?" I said that all the symptoms are hard to treat--that, in fact, bipolar depression is a very difficult illness to treat. Out came his computer, with a slide showing that Seroquel successfully treated every one of the depressive symptoms in one study. "Now doctor, if you had a patient come into your office with suicidal ideation, and you had an agent that would help those symptoms in a week, wouldn't you want to use that agent?"

Of course I would, and there are many other agents that will work better than placebo in a week. But my rep wasn't interested in talking about the alternatives. The focus, as always, was on his product, and on his bonus.

I've printed out the National Physicians Alliance's brochure, "Why Doesn't My Doctor See Drug Reps?" and will put it in my waiting room. I'll let you know how my patients respond. For now, I'm still accepting samples (making me the most despised of doctors among drug reps, a "sample-grabber") but that will be the next to go.

76 comments:

therapyfirst said...

I'm surprised on two counts you still have reps in your office:
1. Your well known position on being a past speaker and now recanting on it(which I support) and
2. Your comments on the role such behavior plays in skewing the judgments of our colleagues.

You know, you haven't commented to me in any form, on this blog or via personal email, about the role of atypicals in managing depression. I know you agree with it to some degree, but really, with what we know of the risks with novel antipsychotics in use with affective disorders, and Ronald Pies noting in a Perl column in the April 08 Current Psychiatry that there are greater risks for TD with atypicals than previously reported, why aren't you at least a bit cautious with this push by Astra Z, Bristol M re Abilify, and the notorious ongoings by Lilly with Zyprexa and Symbyax.

I really would appreciate some form of rebuttal, or agreement from you. Rigid or not on my part, I still see this drug class as our downfall if we do not push harder for objective lit to clarify this application. I mean, $6-10 a pill?

live, love, and laugh.

Anonymous said...

I find it laughable that any rep that even remotely knows who you are would show up in your office with their DM. Then to do the "dog and pony show" and try to hard sell and hard close you is even more laughable.

Yes, I am a rep, but honest about my products. I would treat you with kid gloves and basically, let YOU teach ME about bipolar depression, therefore YOU can tell ME what is good and what is wrong with my product. You're the one with the experience regarding the disease state! This knowledge can only help me better convey my products to other physicians.

I would NEVER bring my DM in with me (unless you requested the meeting).

Have a small amount of pity on the rep and the DM. Reps are compelled to impress the DM with all of the "sales skills" that they are rated on. Also, the two of them are probably dolts who don't keep up on the nuances of their field/territory and don't know who Dr. Carlat is.

I live in Florida and I know who you are. I am a reader of this blog as well as The Carlat Report.

gabe said...

Bravo, doc! This was a joy to read. Keeps the faith that someone is doing right in psychiatry.

InteractMD said...

That's what you get for getting into discussions with the reps. I use their visits now as marketing opportunities for my website. They are good at feigning interest, but a little "counter detailing" is a good way to get them moving out of the office quick.

I will ask them if they've got any news for me. New indication? New clinical trial results? I'm always up for learning new things.

Now that I am keeping up with the news every day, I realize that a lot of their "pitch material" is tired old rehased information. It's not very interesting, and though they can dress it up with a shiny brochure and some pens, it's still just a tired old piece of information, and gets stale quickly.

I also like to have a little fun sometimes, like when I realized that competing ovarian cancer products scheduled webinars on back-to-back days. The rep was less than thrilled that I brought that to her attention.

Another rep was shocked that Genentech had sponsored a live satellite simulcast at a restaurant.

Still another rep was unimpressed that I had written a love letter to his product, unsolicited, on my website. Apparently, credible, uncompensated testimonial is not that interesting to him. Oh, well. At least Genentech is paying attention to my posts now.

I think anonymous was right--these were two knuckleheads who didn't know who they were dealing with, violating an important Rule of Power.

Michael S. Altus, PhD, ELS said...

I'm disappointed that Dr. Carlat decided to no longer allow drug reps into his office.

Dr. Carlat took a public role of gathering information about practices that he does not like and then communicating about them in various forums, such as his blog. If he no longer has drug reps in his office, then he can no longer continue gathering information from an important source. How else can Dr. Carlat comment on and advise others about drug rep practices without experiencing them for himself? How else will various stakeholders be informed?

A better approach would be to resume gathering information and then exposing it.

Supremacy Claus said...

Dan: For some reason, any form of debate upsets you. As a left winger, censorship and shunning is the response.

Aside from trading 5 minutes of time for $2000 in free samples for your needy patients, what harm took place in that encounter? Someone dared to question your argument by authority.

The left gets all huffy about nothing. Meanwhile, their proposed regulations are self-dealing, hypocritical attempts to hijack public education and assistance funds from drug companies.

Do they want that money sent back to the shareholders? No. It is to go through central offices of Hate America left wing indoctrination camp universities or unregulated organizations, run by left wing zealots. The brazen rent seeking of these zealots degrades clinicians and hurts patients who need support from drug companies.

therapyfirst said...

Re Dr Altus's comment above:

You are disappointed doctors do not want floridly biased opinions in a profession that is dedicated to providing care in as unbiased and objective venue?

To take a stab at an analogy, it would be having a political party representative call me and tell me to join their party and vote for their candidate(s) because they are the best and only one who can represent me, and then tell me in the next breath to ignore what the other parties say because the other parties are misrepresenting their true agenda.

Sort of like projection?

When money is involved, truth and fair representation is skewed.

A responsible doc gets info from various sources: reliable literature, contact with colleagues, FDA reporting. You can always choose to let reps in, it's just what and how they present their "facts" you must be cautious. Where do these reps get off schmoozing my secretaries and non-physician clinical colleagues with pharmacology info!?

Read Dr C's Posting from about two weeks ago re the former rep's account of what the agenda is.

I'm curious: your stance in this issue disappoints you in what way?
Stakeholders in what? Isn't this about the relation between doctor and patient? If I'm overreading your comments, then I will stand corrected.

By the way, I made an error in my last comment posting: it should have said "what we know of the risks with first generation, or typical antipsychotics (like Haldol, thorazine, navane) in use with affective disorders.
Sorry for the mistake.

Daniel Carlat, M.D. said...

This is not an easy issue, and I appreciate everyone's comments. I agree that there are benefits to seeing reps--mainly, keeping track of the latest deceptive spins on their products. Theoretically, there is "open debate" but such debate is usually a farce, because most reps don't have any knowledge beyond the talking points in support of their product.

I resisted banning reps for the longest time, but I simply could no longer ignore the feeling of nausea as I listened to their spiels. To imagine that there is any "educational value" in meeting with reps is beyond delusional. And yet, this is the line that I constantly hear from the trade group PhRMA.

The really difficult decision is whether to accept samples. That's something I'll be grappling with over the next few months and will be posting about for debate.

Supremacy Claus said...

Dan: Come on. Let's go. You are sitting on the APA Committee. Let's rehearse.

1) List the harm you are preventing by this exclusion.

2) Enumerate the studies showing any harm to patients from industry sponsorship of CME.

3) Show that increases in the prescription of a new medication comes from marketing, and not from patient results.

Finish these tasks, there will be more.

I am not a member of the APA, nor do I care about its future. However, given you hostile feelings, aren't you too biased to sit on such a committee?

Joe said...

Dan,

I also allowed reps to come in and leave samples, though I didn't meet with them for more than a couple of minutes. I then used the samples for my needy patients. However I stopped doing this for a couple of reasons.
First, since I was not prescribing a lot I didn't get a lot of samples. Thus the supply to the patients was not reliable and I felt that was not responsible on my part.
Second, if the patient was really needy then I could usually get free medication through a PAP program. Since I see these patients for no fee or an extremely low fee I could sometimes use guilt to get meds for the patient through the program if they were on the edge of qualifying.
Third, I knew the reps knew that I was giving away a lot of the samples, and I just didn't want to use dishonesty even though it might benefit my patients. The problem with the system is the lack of honesty and I decided that being duplicitous was contributing to the problem rather than being a solution.

therapyfirst said...

a reply to Joe:

your experience is interesting. What I have found is similar, but I believe, maybe moreso hope, that my threats to not prescribe the meds that are sampled more often get the reps to give me a fair supply to keep patients on a realistic dosage until the patient can mobilize and apply for MA or a PAP. My only annoyance when this works is they do not sample the lower doses I prefer to use in starting a patient; note Seroquel 25mg, Cymbalta 20mg, lexapro 5mg are some examples we should be offered to initiate patients, but we don't see supplied. Splitting tabs is still a hassle to some, so that doesn't validate the higher doses easily.

As much as I have some regrets with using less new name meds, I am glad i can reconsider the older, established drugs we well know their poisons as much as benefits. TCAs have a place, celexa is my first line ssri most often, and I am rarely, but at times trying low dose perphenazine where warranted. I look forward to when depakote loses its patent.
Even Risperdal is near that point now.

Still waiting to hear commentary to the reasons for/against the use of atypicals to treat depression.

live well, love much, laugh often.

Supremacy Claus said...

"Still waiting to hear commentary to the reasons for/against the use of atypicals to treat depression."

The best people to answer this question are your patients.

Stephany said...
This comment has been removed by the author.
Supremacy Claus said...

Specifically, Steph, what harm have you suffered from the care of your doctor who sees the reps?

therapyfirst said...

Always easy for the non-psychiatrist to voice an opinion or a philosophy about care interventions, until the care actually has to happen. Then, when problems develop, WHO YA GONNA CALL, GHOSTBUSTERS?!

Tell people without insurance and money they can't access a medication that the privileged can.

Let's price all medications the same, and the issue goes away. Oh my god, that's a liberal, socialist capitalism-bashing idea!
Or, it's an idea that levels the playing field. Tell that to Big Pharma. Oh, I forgot, someone needs to buy a Rolls today. So someone else can suffer delusions or be suicidal.
Now that's the American Dream.

Eh, SC?

Supremacy Claus said...

I am still waiting for even an anecdotal instance of harm from any form of drug promotion.

TF: This is from high school, 10th grade social studies, not even Advanced Placement. Central control failed despite the slaughter of 100 million people to impose it.

Not even Cubans or Chinese believe the stuff you wrote.

Here is capitalism. Guess if your patients are better off. The patent is a centrally imposed monopoly. The 20 year term came from the Statute of Monopolies under Queen Elizabeth I. We all know how those monopolies helped the creative geniuses around the Queen generate more innovation.

So, progressively reduce the term by a year, each year, until it reaches 5 years. In exchange, close the FDA. Just eliminate it entirely by statute. All data get published. Doctor and patient decide what to use.

Do you get more tools or fewer tools by reducing the patent term to 5 years?

Here is a hint. Enterprises with zero patentability include fashion, cars designs, and ... medical care.

In two countries, patents stopped entirely, for 10 years. No diff in economic growth.

Stephany said...
This comment has been removed by the author.
therapyfirst said...

SC:
Thalidomide, 1960s, fetal malformations.

Vioxx, 2000s, fatal heart disease.

Serzone, 1990s, fatal hepatic disease.

I'm sure you'll refute these. Your agenda to defend this issue?

By the way, patients are addressing the atypical meds use for depression: antipsychotic "numbing"/sedating is getting misdiagnosed as aggravated depression. So careless colleagues increase the dose further or add more meds to treat a side effect.
Again, will a colleague voice an opinion to the use of atypicals for treating depression? Or should I interpret the silence as deafening?

Is this ongoing comment postings going to get as ridiculous as the one from 3weeks ago, or will we accomplish something this time?

Michael S. Altus, PhD, ELS said...

“You are disappointed doctors do not want floridly biased opinions...?”

No. I want MD commentators such Dr. Carlat and organizations to study the subject and report their findings. Reporting on them means finding out about them.

“To take a stab at an analogy, it would be having a political party representative call me... Sort of like projection?”

No. I want organizations such as FactCheck.org (www.factcheck.org) and individual reporters to examine and report on political comments.

“When money is involved, truth and fair representation is skewed.”

Yes. Following their interest usually means following the money.

“Where do these reps get off schmoozing my secretaries and non-physician clinical colleagues with pharmacology info!?”

Again, I want to learn from MD observers such as Dr. Carlat about how this happens.

“Read Dr C's Posting from about two weeks ago re the former rep's account of what the agenda is.”

The issue is to get information from other sources, such as physicians who critically analyze the experience of receiving visits from drug reps.

“I'm curious: your stance in this issue disappoints you in what way?
Stakeholders in what? Isn't this about the relation between doctor and patient? If I'm overreading your comments, then I will stand corrected.”

I don’t understand “your stance in this issue disappoints you in what way?” Perhaps you meant Dr. Carlat’s stance. Please clarify if you think that it’s worth continuing.

My sentence about stakeholders repeated the previous one and could have been deleted. Yes, this starts with the relationship between the doctor and the patient, the two key stakeholders. Other stakeholders are others who are affected by illness, such as family and friends of patients; third-party payers; drug companies; employers; and the public health infrastructure.

I hope that this clarifies my intention.

Supremacy Claus said...

Today, a doctor suspects a drug caused a congenital anomaly. He blogs it to a site that emails the warning to every doctor in the world. The doctor and the patient decide if the risk is worth the benefit, and no one else, certainly not rent seeking federal functionaries.

There is no valid evidence Vioxx or serzone cause those side effects.

Still waiting for an instance of harm from pharmaceutical promotion.

Supremacy Claus said...

Michael: By his bias and animus, Dan is not qualified to sit on any review committee. The same applies to the other names he provided.

therapyfirst said...

Give me a break with these antagonistic, dismissive retorts.

What is worth studying in a committee sponsored by an organization that has a lot to lose if the truth is validated? My perspective is Dr C would like to see his concerns be heard and reported by his colleagues. Maybe if I was in his position, I would consider participating in this process. But, let's be real folks, politics is pandemic in so many facets of life, the truth gets beat down and kicked to the side so special interests and people addicted to the perks of power crap on those who are unfortunately dependent on this system.

Dr Altus, you want more studies and evaluations of a process that is overtly corrupt? What, so one exception can be used to invalidate the majority of impropriety? Do you believe in the adage, "deeds not words define who you are"? The pharmaceutical industry by in large is beholden to its financial interests first; if you believe otherwise, as I have asked before, what is your agenda to debating this process? Mine is helping patients get better and hopefully stay better, so maybe they don't need me anymore.

Regarding SC, you really tax my efforts to be respectful and interested in your position. I guess the FACT that Vioxx and Serzone are not being widely prescribed these days reflects the mistaken reports of their toxicities. Your efforts to hide behind black and white exclamations of exactness do not motivate me to dialogue with interest.

It's a shame people I have met who mirror your attitude while they cling voraciously to failed rhetoric end up painfully impacted by the tragedy of the errors of their rigid, inflexible ways.

Experience is the best teacher of life. How many more experiences do we need to subject our patients before it is obvious that pharmacology must be used judiciously and cautiously, not whimsically and recklessly?

As I have asked of everyone who dialogues with me, a little transparency, please? If you are a defender of the pharamceutical industry, I appreciate knowing your "stake" in this debate.

At the end of the day, you get tired of listening to bullshit. As far as I'm concerned, Dr C's choice to not dialogue further with reps reflects years of experience that validates his position on the panel. At the risk of offending Dr Altus, I use this analogy I feel I have some stake in providing: Do the Israelis need to keep hearing the disgusting rhetoric of the Palestinians to formulate Israel's position in the resolution of this conflict? No! We as doctors know the position of Big Pharma. We are not ignoring information by not receiving reps in our office. We are just making sure we get all the information and not being used to propagate someone else's agenda.

Yeah, I have come to the realization this is a battle. And the civilians here, the patients, are going to be protected as best I can provide. Gee, I guess that's a terrible special interest on my part.

Listen, learn, and change!!!

therapyfirst said...

A little transparency on my part;
books I have read that have influenced me in this debate:

Selling Sickness, by Ray Moynihan,
On the take, by Jerome Kassirer,
What your doctor won't (or can't)tell you, by Even Levine
Critical condition, by Donald Barlett
and my favorites:
How Doctors think, by Jerome Groopman
Severed Trust, by George Lundberg
The truth about drug companies, by Marcia Angell
Prozac Backlash, by Joseph Glenmullen

and am reading now
Generation RX, by Greg Critser

and a book everyone who has a supervisory role in their occupation should read: Trust Rules, by Linda Stroh

anyone else want to share?

Supremacy Claus said...

You forgot, David Healy's books.

Each has no credibility, as Dan has none, by bias and animus.

Lawyer fear made Merck take Vioxx off the market. The FDA, to its credit, demanded it return. That bonehead move disrupted the care of millions of patients doing well on it, including many left wing aging hippies. They wanted it back.

I made out well, buying Merck stock at the time, seeing it soar within a short time.

therapyfirst said...

anyone interested in another perspective to this debate on pharma's role with meds, go to npalliance.org, go down to the reading room area at bottom of the page and link to the top article, from the NT Times, april 6. Another example of how our wonderful pharma resource tries to hide its agenda from the public.

And you want me to listen to reps?

Save yourself some typing, SC: I don't care for your rebuttal to this mention, but thanks for some transparency in your last comment. I hope your Merck stock investment buys you lots of wonderful things, like, maybe a conscience. It speaks volumes to note how you make gains from others' losses. For me, it reinforces my point. Thanks, sir.

Stephany said...

TF: Book recommendation:

Uncomfortably Numb, Charles Barber

Supremacy Claus said...

TF: How do you know I am male?

No one died in the Vioxx study. No one even had an MI. I invest in evil. The evil was the lawyer induced fear of litigation. The evil was the removal of a good medication helping millions of people without adverse effects. There were 4% cardiac "events," such as chest pain, on Vioxx, versus 2.5%.

The same difference in proportions as with the bogus black box warning for suicidality with anti-depressants. Again, if one corrected for the large sample size, those proportions lost their statistical significance.

Years ago, I discovered this good investment tactic. Invest in evil. For example, I bought Magellan stock with their own settlement money after I sued them. At one point, it got so cheap, I could have bought a controlling one third interest for $250,000. I bitched and moaned about Magellan. However, when it came time to step up, I punked out. With controlling interest, they would have come to me, and asked, "SC, how do you want to manage these 67 million lives?" I have no idea. I do not want such responsibility, for any monetary reward. So I kept my cowardly hands in my pockets. Soon thereafter, outside companies stepped in with $100's of millions to bail it out.

I did well enough, but reality silenced me about Magellan. I saw county providers orchestrate the removal of corporations like Magellan. It was catastrophic. There is a reason these evil corporations exist, even after bankrupt. They further the best interests of the preponderance of people, buyers such as employers, consumers such as patients, and providers.

If the left succeeds in its hate filled agenda to take down these drug companies, it is patients that suffer. It will be a good buying opportunity for those investing in evil. They will pop up under other names in India or China. Those hyper-capitalist nations would love to eat our pharmaceutical lunch.

Here is a test for the left wing extremists here. Buy one share of Walmart. Period. It cost about $50. Then, try to maintain the erroneous left wing extremist ideology.

Anonymous said...

As a rep, I am responsible for the following:

Notify physicians of formulary changes.
Notify physicians of co-pay changes, and any programs the pharma company has to make the medication more affordable.
Notify physicians of new indications.
Present a study and how the study fits the physician's patient population, or present and determine if the new information is important to the physician.
Leave samples.
Leave literature that gets thrown away, so I don't do that often.
Leave the co-pay discount program reminders/cards/brochures, etc.
Invite physicians to peer-to-peer discussions.

Gee, that's about it. I am a walking reminder, a 30-second commercial, and occasionally I bring new and important information to a physician.

I don't go into office schmoozing and kissing up to hope the doctor will Rx my product because he likes me. I am polite, considerate of their time, and I am a nice person, but I don't go in there trying to win an Oscar.

Supremacy Claus said...

I have patience. I will wait for an instance of harm from drug company promotion.

Here are other tasks for the drug rep.

1) transmit questions requiring extensive literature review to the science department;

2) transmit complaints about medication to the leadership, about unavailability of low doses, routes of administration (liquid, depot); those black box warnings dump future liability on the clinician are adversarial to the clinician; inability to get insurance coverage;

3) help cash strapped agencies with supplies, meals during continuing education that double attendance; assist their patients obtain applications for long term scholarships; providing coupon numbers off hours for emergency filling of prescriptions;

4) arrange for meals for physicians who openly bash the product, sharing problems, and chastening others who have not yet tried the product. These remarks and questions are transmitted to the leadership of the company. High officials will travel long distances to review such complaints in person. Drug reps hearing such reports will help busy doctors fill out Medwatch forms to report any adverse event to the FDA on the spot or later.

Dan, being blinded by bias and animus, will never report such to his review committee, nor will any of the left wing ideologues pressuring centralization of drug company support funds.

They want a central fund to dispense all funds, empowering these centralized agencies, raking off massive fractions for themselves, and leaving crumbs for clinicians and patients.

therapyfirst said...

I appreciate the anonymous rep's comments, and don't get me wrong, I know that drug reps are working a job, so the ones who give me the impression they are staying in the boundaries of that job description are respected. I even advise the ones who would be interested in Dr C's Report his site and copies of articles if they express a sincere interest.

That said, I appreciate SC's 2PM posting for some effort of transparency, but don't expect me to thank you or commend you for your efforts at investing in evil.
Maybe your gut in not investing in Magellan should have driven you in a more positive direction thereon.
And if you are being sarcastic and challenging just for fun, I don't enjoy it, I'm not entertained by it, and I am not interested in reading your monologues. You don't know me, my parents, and you don't know my political convictions, so just stick to the points of this blog and drop the political banter, or just ignore my postings and I'll ignore yours.

By the way, it ids you as a male in your blog profile, so unless you lied about that, that's how I know!

Well, it's Sunday night and still no one who is a clinician has offered a position on using atypicals for depression. Man, that silence speaks volumes!!!

Sleep well, the week awaits.

Supremacy Claus said...

TF: I think I may have said a few things in my profile. Did you believe the rest too?

I will give you a use for second generation anti-psychotics in depression without psychosis.

Everyone with recent suicidal behaviors or urges gets one. Everyone who can hurt themselves is different, and cannot do without one.

Now, you to cite a specific patient harm from drug company promotion.

ther said...

Zyprexa, by Lilly, Weight gain and Diabetes risk; hence the $750 million lawsuit settlement in 2006.

twist it as much as you want, it is fact; Lilly promoted the hell out of it which is why so many people went after them.

By the way, your comment about using atypicals for suiciality is meritless, if not a bit absurd. I look forward to your alleged unbiased source/study to try to refute me. there is no responsible source in lit I have read in the past 2 years to defend use in depression AS A PRIMARY AGENT. Yet, we are to believe otherwise from Lilly, Astra Zeneca, and Bristol Meyers. Just ask the reps! Gee, I tied it in to this discusssion!

Stephany said...
This comment has been removed by the author.
Supremacy Claus said...

Repeated on-off experiments by patients prove the effect against self-injury and urges.

Monotherapy was last acceptable in the 1980's. It acceptable in mild, non-dangerous patients today, as in family practice grade patients.

Name an instance in which exposure to promotion or sponsored material harmed a patient or you.

Michael S. Altus, PhD, ELS said...

Another book:
“Our Daily Meds” by Melody Petersen

See Janet Maslin's review in the NY Times, March 17, 2008: The Case for Another Drug War, Against Pharmaceutical Marketers’ Dirty Tactics
http://tinyurl.com/63ntle

Joe said...

Therapyfirst,

I will often try a very low (6.25mg to 25mg) dose of Seroquel for depressed patient to help them get more restful sleep, especially if the antidepressant is not helping them sleep or is causing some insomnia.
Very few people have had any difficulty on such low doses, and it avoids a benzo or the fugue states caused by Ambien. I know Trazodone and Remeron can help with sleep, but sometimes the Seroquel seems to work better.

Hope that helps.

PS: Are you familiar with the book Stress, the Brain, and Depression by Hermann van Praag? Technical, but very thought provoking and may explain why so many different medications have such very different effects.

Stephany said...
This comment has been removed by the author.
Child Psychiatry News said...

Left wing ideologues fail at the Supreme Court.

http://www.law.com/jsp/article.jsp?id=1208169984001

therapyfirst said...

First business, then the rant:

Joe: I agree with low dose use at or below 50mg, but for short durations. I have seen seroquel help tone down the irritability of Axis II cluster B patients, but again low doses, less than 100mg at least 95% of time. As a sleeper, as Stephany said it well, UNACCEPTABLE choice until less invasive choices fail.
By the way, thanks for the response. I am disappointed the owner of this blog remains silent on the request for an opinion. It still is open for dialogue to me:
where is the appropriate use of atypical antipsychotics as a first line use for depression? NOT psychotic depression, not bipolar depression (another pharmaceutical created diagnosis, in my opinion), but just unipolar, textbook DSM4 depression. That's the agenda here with the companies I have named.

Stephany: did you know that there was a letter to the editor in April 07 APA green journal of psychiatry that suggested Seroquel be a controlled substance for exactly what you note? And yet, here we are a year later and another indication later for a drug that has abuse potential. Fascinating how so many people in this equation have failed the patients. Astra Zeneca is sure happy this is so.

Clinical Psychiatry News: are you Supremacy Claus dissociated, or a new player to this debate? If the latter, my apologies for the mis-association. If this is SC, what is your agenda?!

And now, the rant (kept short):
I am finishing a three plus year position as a consultant for an inpatient substance abuse program, because I am burnt out working with addicts, and the program is closing anyway by the middle of the year. Why am I burnt out? Several reasons, but to relate it to this blog site and comment postings, it is largely due to the perverse over diagnosis of psychiatric disorders for patients who go to inpatient psych units to detox, but in order for the units to get reimbursed for these indigent, non-insured patients, the patient MUST have an AXIS I DX, so guess what it is at least 85% of the time: Bipolar disorder, and usually these people come to our SAP on three or more psychotropics, and again, guess who is usually on the list: Seroquel!! Give the correct guessers a prize, Don Pardo.

I'm sick of the overdiagnosing, I'm sick of atypicals prescribed like pez, I'm sick of colleagues wimping out and succumbing to this bs pressure, and I'm completely disgusted MDs have forgotten the point to medicine: least to most invasive.

I would love to see any and all physicians reading this blog and commment postings answer this ad hoc poll:
If you developed mental health issues(no specific diagnosis) and went to a psychiatrist for a one hour eval (if it even lasted that long), who would take the atypical antipsychotic RX, with what you know? I challenge anyone who answers this question to do it honestly and candidly. I'll start: If I was psychotic, manic, or irritable to a point of possible danger to myself or others, I'd have to look at it. But not if I'm depressed, anxious, sleep deprived, OCD impaired, or chemically dependent. There are others to list, but time and space limit this.

So, to wrap up my profound disappointment of my field, we've sold out the people we've taken an oath to serve, not for free, mind you, but we are servants, like it or not. These companies who legitimately spend time, money, and energy to create products to help improve the health of the public, have succumbed to the ultimate addiction we are victim to as a civilized species: money, and a perverse symbiot, power. The reps are the messengers of this agenda, and I probably fail in being rigid in this position, but I'll be stunned if I'm wrong. CMEs should not be run by the pharmaceutical industry, so I've brought it full circle.

This for me is what this blog is about; a reality check for what we face as doctors, patients, and I would agree with Dr Altus to some degree as other stakeholders: families, spouses, employers, and insurers(this one to a limited degree).

If you read this, thanks for taking the time. I honestly don't know if I can practice psychiatry much longer if I am the minority opinion in this matter of drugs over therapy.

live well, love much, laugh often.

Stephany said...
This comment has been removed by the author.
therapyfirst said...

by the way, thank you for your recommendations of books; my intent by listing what I have read was not anything else but to show what I have accessed.

I did read Comfortably Numb; I was gald to see the author's rec to be in therapy.

Also, I read the review on M Petersen's book, but to be honest, I have read enough of that vein to know the blood.

Hope you'll look at Trust Rules; applicable to any profession.

reread my rant, sorry it was long.

TBTAM said...

I stopped seeing reps in my ofice about a year ago, and have not looked back.

I have many other venues from which to learn about new drugs, the most important of which is the FDA's own website, as well as clinical trials. I did not find it necessary to see reps to get the info I need to provide good, up to date patient care.

I do miss the samples for my patients, however, but that is not the end of the world for any of us.

Anonymous said...

THis is an example of the most egregious rep behavior. I am very surprised they did the horse and pony show for you. It shows their extreme ignorance and poor business skills.

My "Abilify" rep stops in even though I ask her not to. She brings glossys, even though I ask her not to. SHe recently appeared with the Berman article on Abilify augmentation of antidepressants and feigned not knowing what NNT and effect size measures even are.
Needless to say that is the end of her coming into my office!

Anonymous said...

I am bi-polar 2. I take 25-50 mg of seroquel. I have been known when very hypomanic to take 100 but that has only been once or twice in the last couple years. I have been taking this for a couple years now. I adjust the dosage with my psychiatrist knowledge as needed. If I am mancky I take a little more. More on the depression side I take less. You all can belittle the using it for sleep thing, but I have taken remeron, ambien, benadryl and trazadone. NONE of them will put me to sleep when hypomanic. I was in a mental hospital and they could not put me to sleep with their ambien. 4 or 5 days with no sleep is not a good thing. Sleep is nessecary to prevent psychosis I believe? Therefor in some instances it is justified. I sleep now. Before I had ECT I went 9 months never sleep more than 30-90 minutes a night. I sleep now. I have seroquel and seroquel alone to thank for this. Now that I sleep every night, hypomanic or depressed, I am more stable. I stll cycle but its less severe. I do not take large doses, usually 25-50 mg and never more than 100 and that is rare. Is this really such a terrible thing?

Raine said...
This comment has been removed by the author.
Supremacy Claus said...

I think the anti-drug company propaganda has not shown harm. It is an attempt to dictate to doctors, and to redirect these promotional funds through left wing organizations, so they may steal most of it. This movement seeks to interfere with the doctor-patient relationship, and to take away choices.

Beyond these left wing purposes, it is racist. It says, white people with insurance get brand name, expensive medication. Doctors are unduly influenced by drug company promotions. Those serving minority populations with public funding get old, less desirable generics. Most of these could never get FDA approval today, given their side effects. These left wing elitists are racially biased. They also carry the water for huge corporations, bigger than drug companies. HMO's that seek to give minority patients cheap generics.

If one passes these promotional funds through extreme left wing organizations, all disputes end. They will then steal most of them, instead of their benefiting doctors and patients.

The APA and organizations of its ilk are quasi-governmental organizations. For example, they may put a doctor on trial, with rules of evidence and lawyers. Expulsion from such an organization for cause gets recorded as an official act, and impacts the future career.

Their utterances are thus subject to governmental consequences. IF they interfere with the doctor-patient relationship, I would be suing them on racial discrimination grounds.

By his bias, Dan will never allow these points to get made in any review committee. Nor will his biased organization ever allow a member to make such points without getting expelled. It's a pity, a Federal judge may have to explain the law to them.

therapyfirst said...

some follow up:

To the last anonymous comment: you seem to relate you understand your illness and use low doses with appropriate effect. As a bipolar patient, I have no issues with you on Seroquel; it is the unipolar patient I am concerned is inappropriately on this drug class. I applaud your insight and self management effort sincerely. I can only advise you, as you are interested to hear, do not let a provider tell you to increase your dose solely because "it is too low" and yet you are at your best functionally. Good luck in future endeavors, and write back!

To SC: this is my last posting to you as your denial is pathetic. Read today's JAMA article by Dr Joseph Moss regarding the level of ghost writing by Merck to support the use of Vioxx. This is as plain and direct an example of promotion at the cost of patient safety, so I don't give a crap to read your next denial and rationalization that I am wrong or it doesn't measure up to your alleged standards of proof. What are you, a holocaust denier as well?
I'm sorry to Dr C for that last comment, but this person's writings are just ridiculous at times; I have to wonder if the deleted entry above this was one of SC's. If not, then I am sorry for the assumption, SC.

As a last observation, I had a Lilly rep in the office yesterday who just walks into the stock area of the clinic uninvited. She claimed that staff told her she could come back, yet we had to remind her of HIPAA reg's do not allow non-staff in areas where patient care is provided. I felt she was annoyed with our comments, and if so, it just shows what I feel is this entitlement to assume they are part of the staff because they provide these lunches and samples, which, by the way, I do not participate in as I am one of 8 staff psychiatrists in this office.
This reciprocity concept and how it is manipulated just has an evil agenda to me. Sorry if that sounds harsh, but that is my perspective.

I'm still going to end my comment with a request for feedback from providers to if and why they use atypicals as a first line agent for unipolar depression.

live well, love much, laugh often.

James M. La Rossa Jr. said...

I am not aware of a groundswell in the literature for the use of atypicals in unipolar depression, so I don't know where this concern is coming from. In the last year, Psychopharmacology Bulletin received one paper on the subject, which was inconclusive and did not make the cut for peer review.

This morning I pulled posters from the 2007 NCDEU meeting -- which I find is a good venue to identify research trends -- and looked carefully at the Lilly, AZ and BMS-sponsored posters -- looking, specifically, for studies pushing atypicals for first-line treatment in unipolar depression. A poster by Trivedi and Colleagues made an integrated analysis of olanzapine/ fluoxetine combo in clinical trials of treatment-resistent depression, which showed greater efficacy in combo therapy. But they were careful to point out that these patients ALL had historical documented antidepressant treatment failure.

As for the use of low-dose Seroquel to treat sleep disturbance in Bipolar I and II patients, there is much evidence to agree with the Anonymous patient/ blogger who writes above. (At NCDEU, for example, an impressive poster by Jean Endicott and Colleagues.)

Stephany's negative experience re. Seroquel is something worth noting, of course, but I would like to echo Joe's suggestion to read Stress, the Brain, and Depression, by Hermann van Praag? When I started CNS Spectrums in 1997, I got to know van Pragg while he was writing the book and found him to be a terrific resource in understanding the biological underpinnings in psychiatry.

But TF -- back to the original question and apologies for my lack of brevity here (it's expresso time here in Southern CA.)-- but are reps pushing the use of atypicals for first-line depression? In looking at published data, I don't see compelling evidence that the three pharma companies that would be most vested in this concept are driving significant resources to bolster this claim. What am I missing? Regards, jim.

Supremacy Claus said...

Seroquel would be good monotherapy for depression in someone with prior substance abuse. It monotherapy for multiple conditions. I need a new name for that effect. I do not have my Latin dictionary, for killing two birds with one stone. I do not know of anyone using Seroquel monotherapy in patients with primary depression. It may or may not be effective.

Abilify beats placebo in unipolar depression, as monotherapy. Such use may arise as people gain experience with this novel idea.

I found TF's demeaning of Holocaust victims to be quite offensive to their memory. To compare this pedestrian policy debate to Holocaust denial is quite inappropriate. I think Dan should delete all anti-semitic remarks. I would like to hear TF apologize to any survivor or relative of victims who may have been offended by such hyperbole. Not engaging in personal attacks out of frustration with the facts is one way to avoid such displays in the future.

Marissa said...

Wow. While I'm not a fan of drug "pusher" reps, my only concern is how those without affordable healthcare will obtain psych drugs without paying exorbitant costs. I've been in that position before and getting drug samples were helpful. However, I wish they had come from a psychiatrist instead of a PCP.

Supremacy Claus said...

Marissa: The left wing people here do not believe you and your doctor are the best judge of which medication to use. They seek to end all drug company support to avoid your being fooled by their irresistible advertising. The Supreme Court agrees with you. They said, clinical decisions have the presumption of validity. The most famous such case was Roe v Wade.

therapyfirst said...

my evening response replies:

Jim: my issue with atypicals is that I have heard rumblings that reps are noting that their meds have an indication they will be pushing for in the future. I mean, let's look at the cold, hard facts here: schizophrenia has a 1%prevalence rate, Bipolar AT BEST at 2-3%, so if you as a business want to get more bang for your buck, don't you want to access a population that doubles that prevalence rate? They CLAIM their intent is this "bipolar depression" and now as an adjunct or third tier option for resistant depression, but does any reasonable, aware MD not see this covert agenda to sneak in and get an indication as a first line agent for unipolar depression? I'm out of the loop on this concern?

Marissa raises one of my big beefs with reps as well: sampling of atypicals by PCPs. I've heard reps from Lilly and Bristol meyers claim they don't call on non-psychiatric MDs for these products, and yet colleagues tell me they are called on and advised to be diagnosing Bipolar in a PCP office!? Folks, this is bad news, and you legitimize this thinking now, we are an extinct profession within the next ten years. And it's not an issue of saving my job, it's maintaining an expert for a population that will be woefully underserved by those who are muscling in on our turf. There are times I would love to see a PCP or psychologist prescribe with reckless abandon for mental health patients and then come screaming for the psychiatrist to bail them out when the consequences spill out. Do you know I am seeing a patient next week who's PCP put him on Symbyax for a first time diagnosis of Bipolar. Hey psych colleagues, what did we learn about Triavil, Limbitrol, and these other combo drugs from the 80's? Poor choice!

Now that I've gotten some people's attention with my questionable metaphors and analogies, stick to the dialogue at hand. As a jewish person, my point to my examples being dismissed has an air to the absurdity and rudeness of exactly what I said. I'm sorry it was harsh, but it got attention. It's about a fair level of transparency to have an honest and fair debate on these issues, so the lame political tirades need to end too.

To all who are commenting here, I appreciate the perspectives. Again to Jim, thank you for a reply to my question. We'll see if I'm right or wrong.

Cheers, beers, and no fears! Tomorrow is Friday, Passover's Sat.

James M. La Rossa Jr. said...

I shouldn't be surprised, TF, but one can't argue with your logic that with the illusion of efficacy and tolerability, the powers that be will look to increase market share by accessing larger "patient populations." But unless you're a highly skilled PCP (perhaps bipolar themselves), dishing out atypicals as monotherapy for your depressed patients is putting yourself squarely in the legal firing line if something goes south. Some years ago, when Jan Fawcett was pushing for his IMs at Rush to be second-boarded in psych, this could have been a possibility, but that seems like a lifetime ago, doesn't it?

And as far as losing psychiatry to non-psychiatrists, you couldn't fill one medium-sized journal a year with serious psychiatric research authored by primary care doctors alone. When Clinton I initiated the gatekeeper frenzy in the 90s, there was a run on primary care psychiatry-authored papers, but except for guys like John March, I don't see many of them around anymore. Is it possible, nevertheless, to see, someday, as SC suggests, a host of people saved by an emerging class of drugs -- no matter how controversial -- one can only hope that he is right. But in the process, I am willing to bet that (1) the class will be championed by psychiatrists, (2) will be opposed by the status quo, (3) and will be roundly vilified and misunderstood by the popular press. So ... the beat goes on. Until then, keep the faith.

Happy Passover on Friday.

Supremacy Claus said...

The biggest lode of medical innovation at little cost, and little unknown risk is the application of approved medications to unapproved indications. Systematically, test all products for all potential conditions.

So, your headache patients spit up blood on aspirin. That giant nuisance side effect is a benefit to a heart patient needing a blood thinner.

Your blood spitting patients with ulcers improve on an antibiotic, preventing dangerous ulcer surgery.

Tamoxifen breast cancer patients with mania improve. Tamoxifen, an estrogen receptor antagonist is a treatment for mania. Who knew until attempted?

Can't pee on imipramine? So can't kids with enuresis.

The left wing ideologue has criminalized off label discussion lawlessly, in violation of the Free Speech Clause, to the detriment of patients waiting for a cheap, reliable treatment.

I am among those who wants to ban the FDA. They are in utter failure. They have simultaneously stifled innovation and failed to protect the public from dangerous products. That is because they have a left wing agenda to enlarge government. Their mission statement is a mere pretext, a false application of the law.

Supremacy Claus said...

TF: The Holocaust is among the most documented events in history. The 9/11 conspiracy theorists have been fully debunked by the government. The facts disprove these liars. They are not delusional. They are lying Fascists. Ass kicking is the appropriate response to a liar.

Where is the fact showing a harm from drug company promotion? I would accept anecdotal personal experience.

I will start you off, because the left wingers are having trouble when it's time for the facts to enter. They just want to blow boo-hoo, hot air, left wing propaganda. Here is one.

The standard line during rep visits and sponsored CME for switching was to do it in one day. All doctors doing that did it only once. Catastrophic. The feedback to these left winger academics, at CME sessions, with 100's of doctors listening, has completely stopped that advice. Promotion caused and remedied a harm.

Stephany said...
This comment has been removed by the author.
Supremacy Claus said...

Steph: Is your point that... What is your point?

State your point in a simple declarative sentence.

"Drug company promotions cause ..."

Then provide a fact to support the assertion, not venom.

therapyfirst said...

Sir, your logic is so twisted, It is a waste of time to dialogue with you!

You dismiss every example I give that shows how promotion has had negative consequences, and then demand another example. I wish you'd lose interest and move on!!!

My analogy about Holocaust deniers does fit with you: people who deny the holocaust just keep demanding more facts after they dismiss overt examples, and fabricate/rationalize to distort and minimize the truth. that's what you are doing, sir! I note you have no rebuttal to the JAMA article noted in my comment Wed AM.
Perhaps you are still trying to make up one to fit your twisted model. You come up with some worthwhile points and arguments and then drown them in your right wing rantings. It is pitiful, to be as nice as I can.

So, if this gets deleted by Dr C, so be it. You, Dr C, need to reconsider some limits by your responders; I'll even agree to this on my end. I feel the participants in this blog site want responsible and factual accountability in the debate to the
role of Big Pharma in the control of treatment for patients. I'm trying to keep to this premise; I sincerely request others accept this too. I'd like to hear your point in these discussions once in a while; it is YOUR blog.

There's nothing worse than hearing people complain they wish they could have done something sooner to prevent a tragedy or mistake. Folks, this issue to the role of CME management is headed exactly in such a direction.

By the way, appreciate the feedback Jim. Your expertise is well worth reading.

live, love, and laugh.

Stephany said...

You know what SC? ask Carlat what DTC and reps do for harm. I never said they did harm so shut the fu&%^ up.

James, there is no X is espresso, and you of all people should know that.

At the risk of how TF phrased it once before of being banned from here so be it.

Live love learn and get a life.

Stephany said...

Danny,

Thanks for your time, seriously SC has shut this blog down for coherent conversation, how unfortunate. TF has stated several times he will not return commenting as a result of SC, yet he/she does.

I will not.

Keep up the good work, and all of the best to the working crew in the trenches here.

Supremacy Claus said...

TF: Just list the harms you have discovered from drug company promotions.

1...2...3. Keep it simple, so I can follow it.

I gave you a specific one. Have the same courtesy I showed you.

Steph: You are a patient. I wish you well. I have no dispute with you.

therapyfirst said...

I feel I owe it to stephany and others who might be inhibited or just not invested to comment on the "gestalt" of this comment section of this blog site, so I take the risk to speak for the group:
this is a site I personally value, as Dr Carlat's efforts are something I support and feel are paramount to the struggle for not only psychiatry, but medical doctors in general, to regain control of education and our role in the patient care process. With that said, the constant barrage of this person known as Supremacy Claus ruins the intent and progress of what this site has to offer. So, as I have said before and now, I don't speak for anyone else but myself, I ask of this person to get focused and interact on the issues this site raises as a medical discussion, or please move on to another site where your issues and philosophy will better resonate. Alienating people like Stephany and perhaps others who are not willing to risk your attacks and innuendos ruins the ability for constructive dialogue to occur.

If these comments don't encourage a response by you, Dr Carlat, then I am out of this response section as well. I'll read your blog postings ongoing, but my feedback is not worth this pathetic discourse hereon. In my view, SC is involved to disrupt and disconnect. If He/she goes unaddressed, your site runs the risk of becoming irrelevant. I'm NOT asking SC be barred, just asked to be respectful and responsibly contributing.

Your response or lack of defines my follow up. To all who have dialogued with me, thanks for your efforts and interests. Psychiatry is a great profession; don't let people who are jaded or hostile ruin what we have to offer for those doctors who care and come into the office each day to help people help themselves. That's why I do it.

Good luck, good times, good day.

Supremacy Claus said...

The left wing ideologue always finds any request for a fact to be hostile and disruptive.

Dan is so biased, he should not sit on any responsible review committee without risking destroying his credibility.

I am recording this website, in case Dan takes it down to avoid having his extreme views and animus quoted to rebut any report.

Anonymous said...

SC, I will walk you through what TF has already offered as evidence that promotion causes harm to patients.

Nice and slowly now:

1. Merck flooding the scientific literature with studies and review articles that are ghostwritten or guest authored by academic clinicians who really had no role in drafting the manuscripts or performing the work.

2. If you try and argue that these papers are science after reading this week's JAMA, you sir are delusional. They are simply promotion masquerading as science.

3. In the JAMA paper by Psaty and Kronmal, they show that Merck intentionally misrepresented MORTALITY data related to rofecoxib. You know, little things like more patients DYING on the study drug. They did this to further promote their drug.

4. More patients are prescribed rofecoxib unnecessarily because all of the data are dressed up to make a dangerous drug look good. And not to mention this fraudulent data is jammed down the throats of busy physicians by drug reps who come by just to "educate" the docs.

5. More patients are harmed or possibly killed by a drug that has never proven itself to be any better than cheaper, safer alternatives.

A lot of theoretical advantages touted by biassed sales representatives and faulty science (i.e. promotion acting as science) leads to patients being harmed physically and financially.

Supremacy Claus said...

Anon: Good start. Without arguing each misleading item, name a specific excess harm that took place in the real world, shown to come from drug company promotion.

Since this is a psychiatry site, the enumeration of a harm to a psychiatric patient would be nice too. But any other harm would be great to discuss too. This discussion will help Dan get specific.


"More patients are harmed or possibly killed by a drug that has never proven itself to be any better than cheaper, safer alternatives."

Your dog is paranoid. You would ask the vet for Thorazine over Geodon? Is that what you are saying? Why are minority members of Medicaid less worthy of nicer brand names than your dog?

James M. La Rossa Jr. said...

It's a little scary when the first son of a trial lawyer -- raised in the adversarial tradition, who is a third generation NYer and an unabashed Zionist to boot, feels compelled to mediate. But I want to throw a few things out there, as briefly as possible.

SC: Most readers feel that your question has either been answered adequately, or they do not understand it. Specific examples have been given where drug companies use marketing messages before the full post-marketing surveillance of that drug has been established, which has proven that those marketing claims are wrong and need to be altered or eliminated entirely. (Usually, as you know, this accompanies some hard proof of an increase in morbidity, side effects, etc.) In other words, it is determined (and oftentimes admitted by the company) that the marketing and proper prescribing are at odds. The infamous "Dear Doctor" letter is issued, the company does a mea culpa, drug reps are re-trained (we hope), and Round 2 is underway. As someone who agrees with many of your points, such as the FDA has worn out its welcome, your question -- "[name a] specific excess harm that took place in the real world, shown to come from drug company promotion" has been answered -- perhaps not as specifically as you'd like (no names of reps, dates and examples of promotional materials left w/ doctor, etc.) -- but has been answered nevertheless. The more you keep banging that drum, the less attention is given to your other contributions. One has to live with the fact that not everything can be completely quantifiable, such as antidepressant "poop-out," which everyone knows exists but cannot be scientifically quantified. Thus goes your "promotion/harm" question. (A personal note for the record: ANON was making good points until his #5, at which point he lost all credibility, so I am in agreement with you there...)

Stephany: Dan is running a blog, not a kindergarten, so appealing to him for clarifying comments or to shut SC down, is not his job. As we get "blogged-down" in repetitive debate, he finds new postings, like today's "A BAD WEEK FOR PROFESSIONAL LIARS," and we move the debate forward ... we hope. Open debate in itself will bring 'relevance" to the surface, otherwise readers will move on. (By the way, thanks for the spelling advice -- that hurt!)

Lastly, while there is a time and place for historical events in medicine, the Holocaust discussion has to stop. It was an accidental mention to begin with and it's going nowhere. What's said here is not "evidence." So let's not ruin this great forum with too much repetition. Again, let me recommend today's new posting as one of the best!

Thanks for letting me express those few things -- allbeit, both repetitive and unscientific. Happy weekend and Happy Passover. j

therapyfirst said...

Jim:
well said, heard and respected.
You're on the mark about today's blog posting as well.

It's a shame we waste time discussing issues off the beaten path when other postings should take precedence.

No pizza for a week. Ugh!!!

Supremacy Claus said...

Jim: You know the first question a lawyer will ask upon your entering the room. What were your damages? If you cannot enumerate one, it's then, "Have a nice day."

I still wait patiently. Cite an instance of harm of a patient of a helplessly misled clinician, helplessly doing as the drug company promoted.

Find me data or anecdote. At this point, I will accept the rumor of an anecdote.

I cited such an instance, and its immediate correction by clinician feedback.

I cited the opposing view. By their bogus warnings, the left wing wackos deterred the treatment of depression and assassinated 100's of kids by their subsequent suicide. This left wing extremist wing has blood on its unclean hands.

The pain management of millions of Vioxx patients was disrupted by the fear of litigation by these left wing ideologues.

By their hatred of any competitor to central government in authority, they have obstructed progress and destroyed our economy.

James M. La Rossa Jr. said...

SC: At this point in time, like you, I am more worried about kids NOT getting their drugs because of Black Box Warning-hysteria. Who will stand up and be responsible for these "reverse" damages? Nobody of course. This borders on the criminal. Nevertheless, anytime a lawsuit is brought against a pharma company, however responsible or irresponsible, and Summary Judgment is not granted, it kinda means, by implication, that a judge acknowledges the possibility of damages -- since at least one material fact must be at issue for the Summary Judgment application to be refused. So, the trial moves forward and the clinician's culpability in tandem with the drug companies role becomes an issue of fact to be decided after a full airing. Damages are often admitted -- that's a forgone conclusion -- blame is the trickier element. So, I don't know what to say when you ask, "WHERE ARE THE DAMAGES?" They are part and parcel of any proceeding where a material fact is up for dispute; otherwise, there is no basis for a trial. What more can I say? I am not disagreeing with you. The whole idea that we blame and penalize people who are ultimately trying to help is beyond irony. But doctors have been making unwitting errors since that bad apple in the Garden of Eden. Could one of those mistakes have been made because the clinician was misinformed by someone in industry? Of course. The more interesting question to me is -- who to blame if that mistake was made because of something said in an ACCME- accredited program? Should that be enough to exonerate both the doctor and the pharma company? If not, what's the point? There's no other way I know to try and meet your question halfway SC. That's why post-marketing surveillance is so important.

I look forward to hearing your take, TF, on today's blog? Cheers, j

Supremacy Claus said...

Jim: Dan is immune from me. I have not made up my mind about the APA if they decide to take a heavy handed interference with the patient doctor relationship.

CME programs have absolute Free Speech Clause immunity, even if they cause harm in a direct chain of causation. All of these were immune despite serious injury from reliance upon their advice. A mushroom encyclopedia that caused liver failure in a wild mushroom eater; a chemistry book that caused an explosion by lab instruction; a travel book that failed to warn Hawaiian surf could be dangerous; a cookbook that sickened people who followed a recipe.

Not immune: an aviation map that caused a plane crash, putting a mountain in the wrong place. That was deemed a tool, not a writing.

This is the big one. Kid dives into a pool breaks neck. Collect from homeowner and pool builder. OK. Routine so far. A pool builder association has a set of guidelines that is faulty. The pool builder was not a member, never used the guidelines. Despite the lack of any involvement in the matter, the faulty guidelines were deemed a tort, and the lawyer for the kid owned a pool association annual convention, and all their other assets. The court held, guideline makers have a duty to do no harm. Guidelines have no Free Speech Clause immunity.

As you know the Free Speech Clause is a coin with two sides. The less famous side is the right to hear free speech. If the APA interferes with my right, I may claim a constitutional tort.

If Dan uses these arguments to inform this adversary of the clinician, I would be pleased, not disappointed. I am most interested in preventing a spectacle where docs sue each other to the endless amusement of the lawyers. So I have no hesitation in openly discussing the arguments the APA may face if they do not temper their attacks, and takes a hard partisan stance.

Stephany said...

James, the spelling advice was dry humor, to lighten things up, and hope you would get a laugh from it.

I understand the profound importance of this blog, just kinda getting tired of the SC commentary, but I will live.

Cheers.

Supremacy Claus said...

Steph: Most of my posts are demands. for a fact to support the inappropriate and misleading allegations wildly thrown about here.

The demand for a fact is unbearable to the left wing ideologue. The facts abandoned the left 100 years ago.

Anonymous said...

Cafepharma thread on this post:

http://www.cafepharma.com/boards/showthread.php?t=270887

Anonymous said...

I was prescribed 25 mg of Seroquel for insomnia. My dx: Major Depression. The next morning I felt hung over as hell. I poured the bottle of pills straight into the toilet & flushed. Why not just prescribe people get rip roaring drunk? They will have a lot more fun, pass out, & get that same foggy hung over as hell feeling in the morning. I don't know why people abuse that crap. I recommend those who prescribe it to try it some night when you can't sleep, then get back to me.

Anonymous said...

Are Drug Reps Really Necessary?

One of the main functions of pharmaceutical representatives is to provide free samples to doctor’s offices presently instead of authentic persuasion, and these samples in themselves cost billions to the pharmaceutical industry. Yet arguably, samples are the most influential tool in influencing the prescribing habit of a health care provider. Let me be clear on that point: Its samples, not a representative, who may be the top influencer of prescribing habits.

Yet considering that drug promotion cost overall is approaching 20 billion a year, combined with about 5 billion spent on drug reps themselves, what if there is another way for doctors to get free drug samples, which is what they desire for their patients to initiate various treatment regimens? What if prescribers could with great elation avoid drug reps entirely?
There is, actually, a way to do this, but it is limited. With some select, smaller pharma companies, doctors have the ability to order samples by printing order forms on line for certain medications through certain web sites associated with the manufacturers of these samples. Some examples are such medications that can be ordered in this way are keflex, extendryl, and allerx. Possibly several more can or are available to prescribers in this way. Others, however, cannot be acquired by this method.

So in some situations, a doctor can go on line, print off a sample order form, fax it into a designated fax number after completion of the form, and the samples are shipped directly to the doctor’s office with some products thanks to their manufacturers who provide this avenue. There is no review of the doctor’s prescribing habits. No embellishments from reps actually sounds pretty good.

Usually, this system is available for those smaller companies with very small sales forces to compensate for what may be vacant territories, but can be applied to any pharmaceutical company who, upon discretion, could implement such a system.

Now, why is this not done more often? Apparently, it is legal to obtain samples in this manner. If samples are the number one influencer of prescribing habits, why spend all the money on reps to deliver samples personally? It’s worth exploring, possibly, since the drug rep profession has evolved into those who become UPS in a nice suit.

Think of the money that could be saved if more pharma companies offered samples to doctors in this manner. Furthermore, additional benefits with this ideal system are that there is no interruption of the doctor’s practice. And again, there is no risk of bias presented to the doctor by a rep, as they would avoid contact with reps if they order samples through this way- to have the samples directly to be shipped to their office.

When samples are shipped to doctors’ offices in this manner, prescribing information of the particular med is included with the samples shipped. Doctors can order and utilize samples according to their discretion, and would be free of interference from the marketing elements of pharmaceutical corporations. Patients benefit when this occurs.
Considering the high costs associated with the pharmaceutical industry, having samples shipped directly to doctor’s offices should be utilized more than it is presently- regardless of the size of the pharmaceutical company.
Something to think about as one ponders cost savings regarding this issue.

“The new source of power is not money in the hands of a few but information in the hands of many.”

---- John Naisbitt

Dan Abshear

Anonymous said...

You Have Now Been Sampled (Drug Reps, Part 2)

While the pharmaceutical industry’s image and reputation has suffered, and has been complicated with their declining profits due to a few reasons, these companies still apparently insist on keeping most of their gift- givers on board. Known presently as simply drug reps today, this job has become a vocation void of a sense of accomplishment, which will be described below.
So they may be named at times in different ways, these promoters will be referred to as drug reps, which number close to 100,000 in the U.S. presently, it is believed. The cost to the pharmaceutical industry of these employees is around 5 billion dollars a year. Income for each rep grosses close to or above 100,000 grand a year on average, along with great benefits and a company car, as well as stock options as they gladly work from their homes.
The main function these days of drug reps, I believe, is primarily to offer doctors various types of inducements of a certain value. The drug sampling of doctors may be considered an inducement, and a rather valuable one for the drug rep, as many believe that these samples are what ultimately influence the doctor’s prescribing habits over anything else, including statements from drug reps. This may be why the drug industry spends around 20 billion every year on samples.
While historically drug reps have used their persuasive abilities to influence the prescribing habits of doctors in an honest and ethical manner. However presently, most health care providers now simply refuse to speak with them, or have banned all drug reps permanently from their practices for a number of reasons, including the recommendations from their colleagues. It is possible that this may be due to the following reasons:
1. The doctors lose money. Doctors are normally busy, so their time is valuable. As a drug rep, you are a waste of their time. Yet they will accept your samples still. The credibility you possibly have as a rep is not considered anymore to be present in your vocation due to various controversies associated with the pharmaceutical industry, it is speculated.
2. Most drug reps in the U.S. are hired for their looks and their personality. As a result, many are somewhat ignorant in regards to anything that is clinically relevant to a medical practice, so doctors seem to know this and have responded in such ways. Most drug reps have college degrees that do not correlate with their profession as a drug rep, which is to say that the clinical training of drug reps is limited. In fact, many consider this of such a serious nature that an Act is presently being considered called the SafeRx Act that would certify pharmaceutical reps, and this would be mandatory. One main reason would be to ensure personal accountability for their tactics and statements, I believe, which may improve the quality and safety of their function in the medical community.
3. Many drug reps, it is believed, are void of any ethical considerations due to ignorance of what they are coerced to do or say to prescribers by their employer, and this allows them to embellish the benefits of their promoted products at times in addition to offering inducements to doctors. This is usually due to the rep being unaware of the consequences of their actions at times, yet at other times what reps say is with premeditated intent for potential financial gain for such a drug rep. Worse yet, due to pressure to keep their high-paying jobs, they always are anxious to please their superiors, who require them to offer various types of inducements to physicians that are designated targets of a particular drug company. Such tactics are especially true with the larger drug companies. These reps are in fact coerced to spend these individual promotional budgets assigned to them by their employer. While legally risky, the drug companies continue to dispense to their reps these large budgets reps have been forced to be responsible for dispensing, and are required to spend these budgets. In fact, so much emphasis is placed on this promotional spending, there seems to be an association between the money a rep spends and the progression that occurs with their career working for their pharmaceutical employer. Disclosure laws are being considered presently to mandate the release of all funds dispensed from pharmaceutical companies, which is to say to allow others to see where their money goes and who it goes to, as it is presently very secretive, overall. It is not unusual for a big drug rep to spend 50 thousand dollars a year for clinic lunches alone. In addition, drug reps hire doctors as speakers for certain disease states, and they find many other ways to spend this money they are required to spend.
4. Another issue is what is referred to as data mining. The American Medical Association sells this prescribing data on individual doctors to pharmaceutical companies, which allows them to track the scripts a doctor writes, and the data is free of the patient names. Yet the names the products prescribed are well illustrated and available to the drug reps. This allows reps to tailor their tactical approach with any given doctor, if they see the doctor at all during an office visit. Worse yet, doctors who greatly support the promoted products determined by this data allow reps to reward those doctors who favor the rep’s products that they promote, and this could be considered a form of quid pro quo. Laws are being considered presently to prevent this practice of allowing reps to have this data. Doctors are opposed to the data the reps have as well about them for privacy and deceptive reasons, so they say.
5. Overall, reps can be best described as far as their function goes with their profession is to, whenever possible, manipulate doctors with remuneration or other forms of inducements, as they also continue to sample such doctors along with others their promoted meds. Also, frequent lunches are in fact bought often for doctors’ offices and their staff as a method of access, primarily, as stated earlier with the money reps spend earlier for this type of function. Essentially, because of the income and benefits the drug reps receive that they would likely not be able to obtain with any other job, they are compelled to do such unethical if not illegal tactics mentioned earlier that they perhaps normally would not do in another setting. Usually these drug reps rarely refuse to implement such tactics encouraged to them by their employers.
6. Samples keep the prescriber from selecting what may be their preferred choice of med due to cost savings from samples left with a medical office by a drug rep. In addition, doctors are now being paid by prescription providers, which are called pharmacy benefit managers (PBMs) that are typically owned by a managed care company to have a doctor switch their patients to generic substitutes, if they exist, and this is often not disclosed to such patients. Apparently, these PBM companies are doing this in response to the activities of the branded drug companies, as they continue pay doctors often for various reasons, which are questionable in themselves.
It is likely that most drug reps are good and intelligent people who unfortunately are coerced to do things that may be considered corruptive to others in order to maintain their employment, ultimately. It seems that external regulation is necessary to prevent the drug companies from allowing the autonomy of drug reps that exists, with their encouragement, which forces the reps to do the wrong thing for the medical community, possibly. Clearly, greed has replaced ethics with this element of the health care system, which is the pharmaceutical industry, as illustrated with what occurs within these companies. However, reversing this misguided focus of drug companies is not impossible if the right action is taken for the benefit of public health. Likely, if there are no drug reps, there is no one to employ such tactics mentioned earlier. Because authentically educating doctors does not appear to be the reason for their vocation. This is far from being the responsibility of a pharmaceutical sales representative.

“What you don’t do can be a destructive force.” --- Eleanor Roosevelt

Dan Abshear