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Showing posts with label pharmaceutical company marketing. Show all posts
Showing posts with label pharmaceutical company marketing. Show all posts

Thursday, June 20, 2024

Psych Meds: Under-prescribing Benzodiazepines and Over-prescribing Anti-Psychotics

 

Wikimedia Commons: Various Pills, Unknown author, Creative Commons Attribution-Share Alike 3.0


I often write about the misuse of psychiatric drugs (and disease mongering by big Pharma). Recently, two journal articles have been published that are in line with what I’ve been saying. (Caveat: I want to make it clear that I am not against the use of psychiatric drugs, which can be very useful and effective when prescribed properly to the right patients).

One of my pet peeves has been the demonization in the psychiatric literature of a class of drugs called benzodiazepines. Probably because they are cheap as well as effective. This includes drugs like Valium, Librium, clonazepam and Xanax. They are used for sleep and anxiety disorders. Whenever they are referred to in the psychiatric press, references to the names are almost always immediately followed by the phrase, “but of course they are addictive.” 

In contrast, references to other drugs, say anti-psychotic meds, are never accompanied by the words, “but of course they can cause diabetes and chronic movement disorders." Nor is any such statement attached to references to a far more often-abused class of drugs: stimulants like Adderall.

Even more strangely, this statement is also usually NOT applied to the references to the so-called “Z-drugs” like Ambien and Lunesta (which are newer and more lucrative for pharma), even though they work in almost exactly the same way as benzos and are just as addictive.

Benzo’s are highly effective for the treatment of short-term insomnia and anxiety, and particularly for the highly disabling panic disorder when it does not respond to an antidepressant alone. While benzo’s certainly can be abused, most of the time they are not. They are listed by the FDA as Schedule 4, which means low abuse potential. Adderall is Schedule 2, meaning a high potential for abuse.

So is benzo addiction really a big problem, especially now that doctors can see if their patients have been getting them from more than one provider? (With the exception of the most addictive benzo – Xanax - there is also no big street market for them). In general, shorter acting drugs are more addictive than longer acting ones, since withdrawal symptoms come much more quickly. 

A new, huge study in Denmark has been published that is consistent with my experience (Rosenquist, T.W. et. al., “Long-Term Use  of Benzodiazepines and Benzodiazepine-Related Drugs: A Register Based Danish Cohort Study.” American Journal of Psychiatry 181.3, March 2024).  It found that only 15% of users stayed on the drugs for over a year, and only 3% for more than 7 years. The median dose stayed rather stable in this population. Long term use of Z drugs was on average higher than with those on a benzo. Patients escalating their intake to higher than prescribed doses was uncommon and was found mostly in people that abused other drugs.

An accompanying editorial in the American Journal of Psychiatry points out that conditions like dementia, drug abuse, and other chronic illnesses often cause bad outcomes, not the treatment itself. As to overdoses, with benzo's they almost are never fatal unless the drugs are combined with opiates (on which one can overdose all by themselves).

When it comes to the overuse of antipsychotics, adding them to an antidepressant in “treatment resistant depression” is widely discussed in the psychiatric press - no doubt because many mental health consultants work for Pharmaceutical companies. 

Now don’t get me wrong, these medications definitely can work in this capacity – I had luck adding Abilify to an antidepressant. (As soon as that drug went generic, the exact same TV ads for depression using a replacement brand-named drug named Rexulti started. The two drugs are nearly identical [what does that tell you?)]. 

The issues are: 1. Using two drugs when one will suffice, and 2. The potential severe side effects of anti-psychotics (especially diabetes and a chronic movement disorder called tardive dyskinesia). There are safer “augmentation” drugs like lithium to try first.

I’ve discussed in a previous post one big reason why depression is labeled "treatment resistant" when it may not be: the conflation of major depression with chronic unhappiness. The latter almost never responds to an antidepressant (not counting the times when it acts like a sedative and is only effective due to that side effect). 

Also, you can be chronically unhappy before a major depressive episode even starts and that is your baseline. If you end up at your baseline, then the antidepressant did work! In that case, the next step should be psychotherapy, not more meds.

These issues tie in with an idea discussed by H. Paul Putman III M.D. in the April 2024 issues of Psychiatric News. He points out that much of what is labeled “treatment resistance” is actually a treatment impasse, meaning the doctors have not done everything they needed to do with the antidepressant or ruled out other causes for the symptoms. They have perhaps not slowly raised the dose until the maximum, or if this becomes precluded by side effects, then trying the same strategy with a second antidepressant and then a third. 

Medical causes such as endocrine disorders have not been ruled out. Maybe there was a rupture in the alliance between the patient and the doctor. Or the patient has not been taking the prescribed antidepressant at full dose all along - or not taking it at all. Interactions with other medications have not been evaluated. Co-occurring psychiatric disorders that are complicating treatment have not been considered.

Putman says the term “difficult to treat” should be substituted for “treatment resistant.” But then Pharma might not make as much money.

 




Thursday, November 18, 2021

The Science of Spin: Big Pharma Propaganda Techniques




IMO, industry uses psychology to get people to change their behavior far more effectively and scientifically than psychotherapists. In an article in Environmental Health, (2021; 20: 33. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7996119/. Goldberg and Vandenberg describe 28 unique tactics used by industries to manufacture doubt or confusion about science when it serves their interests. These messages are then frequently amplified by perpetuators of doubt – journalists, bloggers, citizen scientists, and lay-people – who, on their own without direct funding, unwittingly disseminate and spread pro-industry spin. The Pharma industry tactics used to manufacture doubt are:


1

Attack Study Design

Emphasize study design flaws in negative studies that have only minimal effects on outcomes. Flaws include issues related to bias, confounding, or sample size

2

Gain Support from Reputable Individuals

Recruit experts or influential people in certain fields (politicians, industry, journals, doctors, scientists, health officials) to defend their biases in order to gain broader support

3

Misrepresent Data

Cherry-pick data, design studies to fail, or conduct meta-analyses to dilute the work of critics

4

Suppress Incriminating Information

Hide information that runs counter to their interests

5

Contribute Misleading Literature

Use literature published in journals or the media to deliberately misinform, or use peripheral topics as a distraction

6

Host Conferences or Seminars

Organize conferences for scientists or relevant stakeholders to provide a space for dissemination of only information in line with their economic interests.

7

Avoid/Abuse Peer-Review

Avoid the peer-review process to publish poor literature, publish without revealing funding sources, use the journal name to add weight to claims, or minimize need for peer-review among lay audiences

8

Employ Hyperbolic or Absolutist Language

Discuss scientific findings in absolutist terms or with hyperbole, using buzzwords to differentiate between “strong” and “poor” science (i.e. sound science, junk science, etc.),

9

Blame Other Causes

Find related, alternative causes for any negative effects that are reported or observed

10

Invoke Liberties/Censorship/

Overregulation

Invoke laws to emphasize equality and rights for expression of their preferred data or interpretations thereof, despite differences in evidence quality

11

Define How to Measure Outcome/Exposure

Attempt to set guidelines for ‘proper’ measurement of exposures or outcomes, while undermining guidelines not in line with what they want.

12

Take Advantage of Scientific Illiteracy (media/individuals)

Emphasize scientific obscurity to confuse lay audiences, or deliberately disseminate unscientific or false but easily digestible information

13

Pose as a Defender of Health or Truth

Represent their goals as health-conscious or dedicated to truth

14

Obscure involvement

Ghostwrite, create shell companies, use attorney client privilege to hide the true source of their data 

15

Develop a PR Strategy

Devise methods for specifically reaching public audiences to spread their messages

16

Appeal to Mass Media

Appealing to journalistic balance, developing relationships with media personnel, preparing information for media personnel, invoking the Fairness Doctrine

17

Take Advantage of Victim’s Lack of Money/Influence

Silence or abuse critical individuals by out-spending or exploiting a power imbalance

18

Normalize Negative Outcomes

Normalize the presence of negative effects of their products to reduce their apparent importance and make them seem inevitable

19

Impede Government Regulation

Overwhelm governmental regulatory agencies to slow or stop their function

20

Alter Product to Seem Healthier

Make modifications to harmful product to reduce public appreciation of their negative effects

21

Influence Government/Laws

Gain inappropriate proximity to regulatory bodies and encourage pro-company policies

22

Attack Opponents (scientifically/personally)

Conduct targeted attacks on opponents by undermining their professional or personal reputations

23

Appeal to Emotion

Manipulate an audiences’ emotions to draw support for their claims in the absence of facts

24

Inappropriately Question Causality

Argue that correlation does not equal causation despite the presence of strong evidence

25

Make Straw Man Arguments

Publicly refute an argument that was not even made by the opposition

26

Abuse Credentials

Use qualifications in one discipline to assume authority in another discipline

27

Abuse Data Access Requests

Requesting access to data in order to misrepresent and attack, employing Shelby Amendment, Freedom of Information Act, etc..

28

Claim Slippery Slope

Illogically or falsely claiming that there will be disastrous consequences if their ideology is not supported

Tuesday, February 2, 2021

The “Logic” of Researchers in ADHD

 



About 15-20 years ago or so, when I was still Director of Psychiatric Residency Training at the University of Tennessee Medical School, I went to a grand rounds (a teaching conference involving the whole department) to hear a talk by a doctor about adult ADHD. It turned out to be more of a drug commercial for some or other stimulant the sponsor of the talk was selling.

The guy basically said that this pseudo-diagnosis was in fact incredibly common – up to 14% of the adult population – and all of them should be taking significant doses of one of the most dangerous and addictive class of drugs that are available by prescription – classified by the FDA in the same category of abuse potential as opiates like morphine. Wow.

During the Q&A at the end of the talk, the subject of ADHD in children came up. Someone asked him why so many kids diagnosed with the disorder could go to a video game arcade (which had at the time only recently gone the way of the dinosaurs) and concentrate with tremendous focus on the game they were playing despite all sorts of buzzers and bells going off, flashing lights everywhere, and scores of people milling all around talking to each other. The speaker opined that this was “not concentration.” I’ve heard that sentiment many times before and since from Pharma shills. Well if it isn't concentration, I wondered, then WFT is it?

Another skeptic in the audience from child psychiatry asked him about the high incidence of alcoholism in the parents of ADHD patients. His response: “If you had a kid like that, you’d probably drink too!” Oh, I see. Alcoholism is caused by having rambunctious children.

I should have gotten up and cussed the dude out for saying heinous stuff like this, but my boss in the department might have frowned on it.

All this reminds me of another talk I once heard from someone from the National Institute for Drug Abuse during an outside medical meeting. He was going on and on about how cocaine, another stimulant BTW, depletes a chemical in the brain called Dopamine, which makes it nearly impossible for abusers to enjoy anything but the drug. Someone (again, not me) got up and asked, “But aren’t we doing that when we prescribe stimulants to our kids?” The speaker’s answer, “But the drugs work so well.”

So I’m guessing that the answer to the question that was actually asked, which the speaker completely avoided, was, “Yes.”


Tuesday, July 9, 2019

NAMI, Big PHarma, and Family Therapy




Back in the beginning of June 2019 I received an e-mail from a manager in marketing and communications in NAMI inviting me to write a blog post for them, as they were planning on featuring articles in August about personality disorders. I replied that I would be happy to do so. However, I wrote, since I discuss the relationship between family dynamics and personality disorders, what I write might be offensive to some of NAMI readers. The manager then suggested to me that I could avoid that and write about what it means to have a personality disorder and how they are diagnosed. 

I agreed to do it, but had a strong suspicion that they would not like what I would write. I believe that personality disorders are different from other diagnoses in the DSM diagnostic manual and that the now-eliminated separate classification (Axis II) should have been retained. A copy of said blog post follows this introduction.

I was right. Soon after I turned in the post, I received an e-mail from higher up on the NAMI food chain, the Director of Marketing Communications.

She wrote: “…it appears there may be a misunderstanding about the agreed upon blog topic about what it means to have a personality disorder and how they are diagnosed. There are elements in your submission that do not align with NAMI’s position and educational materials about personality disorders. We align with the DSM-5 categorization of personality disorders as mental illness.”

I wrote back thanking them for the opportunity, but basically saying that I was not going to write a post as if the definition of "mental illnesses" in the DSM diagnosis list was not broad, and that it obviously covered some behavioral syndromes that are not brain diseases. Furthermore, by design,the DSM says nothing about etiology (causes of the disorders).

So why did I sort of know this would happen?

NAMI started out in life as advocates for the severely and chronically mentally ill – mostly people with schizophrenia. In the past, they had done some great work in this regard. I know that members were rightfully furious with both psychoanalysts and especially family systems therapists for blaming what is essentially a biological brain disease on family dysfunction. Of course, stressful family environments can make the presentation of any psychiatric or physical illness worse, but most readers probably know by now that I do not believe that schizophrenia is caused by family double binds or schizophrenogenic mothers.

Unfortunately, the NAMI membership morphed into those who dislike anyone who would dare suggest that ANY diagnosis in the DSM just might be created by severe family dysfunction. This position was attractive to the guilty parents I mention in the masthead of this blog, who do not want to look at their own family dysfunction, and therefore put a lot of store on phony “biological” psych disorders like pediatric bipolar disorder and adult ADHD. They joined the parents of people with actual brain disorders in the advocacy group.

In the post I submitted, I purposely did not mention adverse childhood experiences or family dysfunction in making the case that personality disorders (not including Cluster A – see the post) were behavioral syndromes and not brain diseases. Still, some members of NAMI might suspect that that was the implication of the piece. Unfortunately, there was also a second thing going on at NAMI that, although I cannot absolutely prove that the two factors led to the rejection of my post. They clearly seem to point in that direction.

This second process happened around the time that there was a major change in how NAMI derived the bulk of its funding. In October of 2009, the New York Times reported that Senator Charles Grassley had been looking into how patient advocacy groups like NAMI were getting a good portion of their funding from big PHarma. He found that drug makers from 2006 to 2008 contributed nearly $23 million to the alliance, about 75% of its donations. NAMI has long been criticized for coordinating some of its lobbying efforts with drug makers and for pushing legislation that also benefits industry.

Although I was unable to find more recent reports, there is little reason to think that this has changed significantly. Of course, if all DSM diagnoses were brain disorders, then they should be treated with pills, not psychotherapy. This increases drug sales. NAMI has clearly fallen under their spell.

Here’s the rejected post:

Is a Personality Disorder a Brain Disease?

Personality disorders (PD’s) are mental disorders defined as problematic, lasting patterns of behavior, thinking, and inner experience, exhibited across many social contexts – but, importantly, not all contexts. This latter point is seldom appreciated. The patterns are in fact often dependant on specific types of interactions and situations with certain other people, and may completely disappear at other times. People who exhibit symptoms of one of the more severe disorders, borderline personality disorder (BPD), are well known for creating arguments between doctors and nurses on hospital wards by acting sweet around one set of them, while acting horribly around the other set (the infamous staff split).

With the exception of the Cluster A disorders, described below, they are likely not brain diseases but problems with functioning, especially in relationships with others, and in my opinion the behavior patterns are learned responses. Because the behavior can be quite extreme, some people and clinicians think they simply must be brain diseases, but the neuroscience does not support that. The fact that the behaviors appear and disappear depending on social context shows this; real brain diseases like Alzheimers are not like that. Furthermore, findings on fMRI studies and heritability studies, often cited to “prove” that PD’s are brain diseases, are misleading or fraudulent. Readers can follow the links here to understand how.

Another odd characteristic of PD’s is that there can be over a hundred different combinations of traits that all lead to the same diagnosis. Some traits may even seem contradictory. Narcissistic personality disorder requires at least 5 of 9 different characteristics— Any 5— or any 6, 7, 8, or all 9. One trait is an excessive need for admiration, but another is “takes advantage of others.” It is hard to think of a worse way to gain people’s admiration that to make them feel used!

A patient can also simultaneously show symptoms of several different PD’s in any possible combination. One study showed that once someone is diagnosed with BPD, they also qualify, on average, for 1.6 other PD’s. Any others.

The traits that make up PD’s are said to be maladaptive. This means they cause problems for the intimates of the involved individuals, but also in the long run are self-destructive or self-defeating for the person with the disorder. Over the short run, these traits may be used to solve certain types of interpersonal problems, but the “solution” does not last and prevents the use of better ways to resolve ongoing problems.

PD’s were at one time thought by psychiatry to be different from all other psychiatric disorders. They were placed on a separate “axis” from other disorders - Axis II. Of course, all human behavior involves the brain, but as I have argued, PD’s are likely “functional” or behavioral disorders. For this reason, I was in favor of keeping Axis II. However, because insurance companies often refused to authorize treatment for them— despite the fact that they can be highly disabling and require extensive therapy—Axis II was eliminated. (Psychiatry does not consider causation in describing its diagnoses, because the true “causes” of almost all of them are not known for certain).

As mentioned, the personality disorders are subdivided into “clusters” that have common themes. The first, Cluster A, consists of disorders that are usually a prelude to more serious brain conditions such as schizophrenia, and probably have little in common with the PD’s in the other two “clusters.” For this reason, I believe that they should not have been classified as personality disorders in the first place, and they will not be discussed further here.

The most serious personality disorders are seen in Cluster B, the “dramatic” disorders. Antisocial p.d., the most difficult to treat, is characterized by disrespect and disregards for the rights of others, often leading to criminal behavior. They rarely come to therapy voluntarily.

BPD is currently the most common. I have noticed a marked increase in its prevalence since I was in training back in the mid 1970’s, which makes me think it is related to ongoing developments and changes in our culture. It is also seen much less commonly in traditional cultures. People with BPD often react with strong anger or panic to seemingly minor slights. This has led some psychiatrists to believe that BPD is a variation of bipolar disorder, but good evidence says otherwise. People with BPD are impulsive, self-destructive, and may cut themselves or engage in other self injurious behaviors. They often worry about being abandoned by loved ones. A history of overt physical or sexual child abuse is a feature in the backgrounds of many of them, although certainly not all of them.

Cluster C personality disorders exhibit highly prevalent anxiety or fearfulness. Those with avoidant PD, for example, are socially inhibited, feel inadequate, and are hypersensitive to negative evaluations by others. They constantly worry about what other people think about them,

Because of their now-you-see-it, now-you don’t nature, a variety of information must be taken into account to make an accurate PD diagnosis. Good clinicians specifically ask about some of the more severe symptoms and behavior in a good psychiatric diagnostic interview, which includes a complete history of the patient’s upbringing and relationships over the course of their lives – things asked about less and less recently. Often it takes more than one session for the clinician to see the patterns. A patient’s behavior with the doctor and with the staff also provides clues. Interviews with the patient’s significant others may reveal important information, although they may at times be just as misleading as patients sometimes are.

Tuesday, December 20, 2016

Yet Another Drug Company Fined for Off-Label Marketing of Psych Medication




Since I started this blog way back in March of 2010, I have posted several times about big Pharma companies being fined for the off-label marketing of various psychiatric medications. Well, the hits just keep on coming.

The Consumerist was one of several news sources to recently report that: 

"New York Attorney General Eric Schneiderman announced the settlement Thursday resolving allegations that Bristol-Myers Squibb improperly marketed and promoted the drug Abilify.
Abilify — the brand name for the prescription drug aripiprazole – is a second-generation antipsychotic prescription drug, commonly, commonly referred to as “atypical antipsychotics,” that were originally used to treat schizophrenia.
According to the states’ complaint, which was also filed today, BMS engaged in off-label marketing, which is the promotion of drugs for uses that are not FDA-approved.
For example, the complaint claims that BMS improperly promoted Ability for pediatric use and for use in elderly patients with symptoms consistent with dementia and Alzheimer’s disease.
This, despite the fact that in 2006, Abilify received a “black box” warning stating that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death.
Additionally, the complaint alleges that BMS violated state consumer protection laws by misrepresenting and minimizing the risks of the drug including metabolic and weight gain side effects and by misrepresenting the findings of scientific studies.
Under the proposed agreement, BMS is prohibited from promoting Ability from off-label uses; making false or misleading claims about the drug; compensating health care providers for attended promotional activities; using grant funds to promote Ability; and providing samples of the medication to health care providers who do not intend to use it for labeled purposes."
Bristol-Myers Squibb settled the claims with 43 states for a total of 19.5 million dollars. That sounds like a lot of money, but for big drug companies, it is actually a paltry sum. Fines like that are considered a cost of doing business

As readers know, I am rabidly against the use of antipsychotic medications in non-psychotic children, which is unfortunately becoming more and more common. However, I must admit I have negative feelings about that black box warning regarding the use of any (not just Abilify) antipsychotic medication in patients in nursing homes with advanced dementia due to Alzheimer's disease or other severe brain conditions. 

Things have gotten to the point where docs are afraid to prescribe these medications even in such patients who are actively psychotic with hallucinations and/or paranoid delusions, for which there are no other effective treatments.
Even in non-psychotic demented patients, antipsychotic meds are often the best agents for controlling assaultive behavior in this population. Unlike other sedatives, they do so while only minimally exacerbating memory and cognitive deficits in these people. Our society seems to want to pay nursing assistants only the minimum wage to take care of our impaired family members as they age. Long-term facilities are very expensive as it is. Not only that, but we under-staff them as well. While there may be psychosocial interventions which would reduce assaultive patients with dementia, we do not want to pay people to provide them.

Given those conditions, what is left? Medications, that's what. Do we really want to expose underpaid and overworked caretakers to dangerous aggressive behavior from patients who basically have no life anyway - just to prevent a tiny percentage of them from dying a little sooner due to the medications' cardiovascular side effects? Time to either pay up or shut up.