Horror Stories in the Public Domain: Often More to the Story

The Nocebo Effect

Since I started this blog, I have corresponded or interacted with several respectful, thoughtful, and caring (as well as some hateful, ignorant, and not so well-meaning) individuals who run websites that are critical of psychiatrists or psychiatric medication, or who run support groups for the parents of individuals with various psychiatric diagnoses. These folks collect and publish horror stories. Some of their readers report having had bad reactions to psychiatric drugs and/or awful interactions with mental health professionals, while others discuss interactions with relatives with specific psychiatric or psychological disorders.  

As to the psychiatry critics' drug websites: Of course, anyone who reads this blog knows that I believe that there are a lot of really bad psychiatrists out there who end up doing real harm to their patients. Mostly, they drug patients unnecessarily or over-medicate them, and do not recommend  - and therefore deprive patients of - psychotherapy or family therapy that might do their patients some real good. Others do not monitor patients for adverse reactions, with sometimes catastrophic results. These websites can often contain information that can be very helpful to such individuals.

It is also quite true that a small proportion of those taking any drug on the market, psychiatric or otherwise, can have bad reactions or bad withdrawal symptoms, and that certain drugs are of such high risk for potential toxicity that they should not be prescribed for anything but the most serious of reasons. Toxicity from drugs that for many people are truely helpful and indicated can be monitored for, of course, but often doctors do not do this, as mentioned above.

While a majority of the horror stories about drugs are therefore probably true, although unrepresentative for reasons about to be discussed, this does not necessarily mean that any story website readers submit about a bad reaction that they seem to have had to a drug is, in fact, due to the drug. That should go without saying.

First, there is what is called a nocebo reaction, which is sort of like a placebo reaction in reverse. People will develop symptoms that are not actually due to the drug itself because of their expectations about the drug - just like people can have a bad or good reaction to a sugar pill that is basically inactive, pharmacologically speaking. The popularity of the obviously bogus science of homeopathy, in which individuals are given what is basically water, attests to the power of placebos and nocebos.

It is ironic how some of the more strident anti-psychiatry folks go on and on about high placebo response rates in drug studies, yet systematically deny that anyone ever has a nocebo response. This lack of consistency is always an excellent clue that anything such a person says may be highly prejudiced, and that their reading of evidence is highly selective.

Of course, people who have good responses to drugs are not going to write into the sites designed for people who have a complaint. In a similar vein, parents who were severely abusive to their offspring are not going to write to parent support groups for the families of patients with alleged psychiatric “diseases.”  Therefore, both the leaders of parent support groups and drug site webmasters are hearing from a highly select sample of individuals who are probably not at all representative of the majority of people who are involved.  

Parents who contact the two support groups for the parents of patients with borderline personality disorder (BPD),  NEA-BPD and TARA, are an excellent example of an unrepresentative sample. Yet the leaders of these groups often deny or minimize the role child abuse and general family dysfunction play in the genesis of BPD because of their tendency to overgeneralize from their readers, despite the FACT that every study ever done shows that these factors are highly prevalent in families that produce children who grow up to have BPD.

As to the people who do seek help from support groups for relatives of people with various disorders: At least some if not most of these individuals have a strong need to blame their interpersonal problems solely on a mental illness that their relatives supposedly have. If that were the case, they would not have to feel guilty about their role in the family member’s problems. I discussed this phenomenon a long time ago in a post about a website supporting the parents of children who supposedly had bipolar disorder but were in actuality just plain ol' acting out. The post showed how Pharma, with the cooperation of corrupt psychiatrists, took advantage of these parents to sell inappropriate drugs for their kids.

Similarly, complainers about drugs may actually be miserable because of family problems, but would rather blame their misery on the drug rather than face the facts of their family dysfunction. This is the defense mechanism called displacement. 

Again, of course there are real psychiatric diseases like schizophrenia and real manic depressive illness, but as readers of my blog know, I believe that what are just behavior and interpersonal problems are frequently mislabeled as "diseases" by both mental health providers and the general public alike, such as ADHD, bipolar (my ass) disorder, and even borderline personality disorder. 

The webmasters for the sites under discussion here, and the leaders of these support groups, tend to just accept the pronouncements of their “customers” as true and complete and do not question them. Blindly taking the word of people who may have several skeletons in their family closets is probably not wise. These are people the webmasters usually do not know at all, although in some cases they may have corresponded more extensively, and there is rarely any way to verify what they say. Therefore, it seems to me that one can easily be misled about both the prevalence and/or the basic nature of these problems from reading these websites.

The same question of whether one is getting the whole story might also be said about letters to newspaper advice columnists. Admittedly, I have been guilty of using such letters to illustrate various points I make on this blog. Some letters to Dear Abby and her colleagues may be completely fraudulent, and they can easily be fooled into publishing a fake one.  

An even bigger problem is that, even when a letter writer is completely sincere, many times he or she is only telling part of a much bigger story. Patients, letter writers, and website visitors can be completely truthful in what they say, but leave out highly relevant facts that would change the opinion of anyone listening to them.

As a therapist, and as I have mentioned in previous posts, sometimes the truth about what is really transpiring with a patient, particularly during their interactions with family members, are not revealed until literally months or even years into ongoing psychotherapy. Family skeletons tend to remain family skeletons for a reason.

A great example of someone leaving out a lot of relevant details, if true, was seen in a couple of letters to the advice column Annie’s Mailbox. A daughter-in-law was accused by a letter writer of what sounded like some pretty rude and unpleasant behavior, and the Annies were sympathetic in their answer to the writer. Then the daughter-in-law herself wrote in with her side of the story. Although I cannot be certain that the letter writers were not making this stuff up, I reproduce the letters because I have seen real examples of patients “spinning” facts to make themselves look better than they are, or in many cases, to make themselves look worse than they are.

These letters do illustrate some of the ways that facts can indeed be “spun” in such a way that a reader or listener is completely misled.

Letter #1: Aug 5, 2013. Dear Annie: My husband and I drove a long distance from our home to help our son and his wife with their move from another state. They have two infant daughters, and we wanted to help in whatever way we could. The first morning, Dad went with our son to the bank, leaving me at the house with the movers. My daughter-in-law stayed in her bedroom with the babies. The movers' questions were directed to me, and my daughter-in-law didn't come out of the bedroom until my son came home. It was hard to believe she wouldn't want to be involved in the decision-making process about where her furniture should go. 

On the fourth day, our son went back to work, and we were left to fend for ourselves in the morning while his wife slept in. There wasn't even a TV to keep us occupied while we waited for her to get up. At 11 a.m., we decided it was time to leave, and we cut our stay short. We called our son on the way back home and explained the situation. In seven months of our son saying everything was "fine," they never initiated any contact. There were no acknowledgements of Christmas and birthday gifts, much less a thank you. There were no phone calls. Now his wife is demanding an apology from us, saying we were rude to leave so abruptly. We believe this was inappropriate behavior on her part. What is your opinion? -- Disappointed Parents

Dear Parents: We think you will have ongoing problems with your daughter-in-law. She was rude and ungracious. But she is your son's wife, and he is disinclined to stand up to her. You will have to work through her if you wish to maintain a relationship with your son and grandchildren. Apologize, even if it sticks in your throat. If she avoids you by staying in the bedroom, don't make it a problem. Learn to keep your negative opinions to yourself. Remain upbeat and positive. Always be nice to her. Remember, you can catch more flies with honey than vinegar.

Letter #2: 10/18/13.  Dear Annie: I am the daughter-in-law mentioned in the letter from "Disappointed Parents," who said I retreated to the bedroom while my mother-in-law handled the movers. From their letter, I can understand why you think I might be a problem. Yes, they did travel a long distance to help us with our move, and it was greatly appreciated. I kept thanking them and continuously asked whether they were OK and whether they needed anything. I was told over and over that they were just fine. The day the movers arrived, my husband and I agreed that he would deal with them and I would keep our small children out of the way in our bedroom. He didn't tell me that he and his father left to go to the bank, leaving his stepmother to handle the movers. 

My husband and I both slept until noon that day, but they only castigated me for being "lazy." They didn't mention that I was up until 4 a.m. unpacking. They were bothered that I didn't have breakfast ready for them, even though the kitchen wasn't unpacked. They expected to be entertained. When they decided to leave in a huff, I was bathing our kids. They didn't even lock the front door behind them. After they left, I received nasty emails saying how rude I was and that I need to apologize. Each one included a laundry list of the ways I am a terrible daughter-in-law and don't know my place. I didn't send birthday and Christmas greetings because my husband said he wasn't interested in doing so. His father has a history of anger issues and has alienated every other family member. My last email stated that I was cutting off contact. I am too busy raising my children to raise my in-laws. They smile to your face while making lists of slights behind your back. I don't want my kids around such behavior. Thank you for reading my side of the events. — Shell-Shocked Daughter-in-Law

Dear Shell-Shocked: Thanks for providing it. Many readers came to your defense, saying that a new mother who had just moved had her hands full and deserved more consideration. We agree.

Often the possibility that details are being left out of a description of an interpersonal problem can be suspected from a very careful reading or listening to what is said. For example, I see a lot of letters to advice columnists by elderly parents complaining that their adult children are ignoring them or are angry at them, seemingly for no apparent reason. In point of fact, there is always a reason. For example:

Dear Annie: I could have written the letter from "Hurt in Florida," whose children and grandchildren don't include her in their get-togethers. My daughter told me they are "just too busy" for me. But they somehow have time for her dad and stepmother, as well as her in-laws and several friends. I haven't seen them in more than a year. We don't talk because I don't call. I don't understand any of it. I just wanted to let "Florida" know that she's not alone. I'm hurting with her. — Midwest Grandma

The key question raised by what is said in this letter is why said daughter seems to love to get together with every family member except the letter writer. Could it be that the writer has distanced her child in some way? You can almost bet on it.

Older Siblings and Neglectful Parents

I have lately been coming across another interesting pattern of family dysfunction. It takes place in families characterized by having several siblings and in which the parents were severely neglectful of them when they were growing up. This pattern is particularly likely when the adult who neglected the kids was the mother.

The neglect might have stemmed from any of a number of factors: parental depression, parental alcohol or substance abuse, mothers who had been bullied by demanding and violent husbands, husband who had made sure that their wives were perpetually pregnant, parents who were overly-enmeshed with their own families-of-origin, families subject to religious strictures against birth control and/or mothers working outside the home, and probably a host of others.

In many of these families, childcare duties fell on the oldest of the siblings, who was pressed into service to take care of the younger ones. This situation is a setup for disturbed sibling relationships after everyone has grown into adulthood.  There are three reasons for sibling discord in such a situation that I would like to focus on and describe:

1. The siblings are angry at the neglectful parents, but they protect their parents from those negative feelings by displacing them onto the older, mother-substitute sibling. 

2.  The older sibling, having no real power in the family and being ill-equipped to be a parent, becomes verbally or even physically abusive to the younger siblings. 

3.  When the oldest sibling is a male and the younger ones female, and when there is no parental supervision as there often is not in such cases, the boy sexually molests the girls. (Occasionally, older sisters will also molest younger sisters).

Problems #1 and #2 frequently occur together, although not always, leading the younger siblings as adults to isolate or even completely exile the older one from the rest of the family. As the parents age, the younger siblings may get together to keep the eldest away from the parents, and to make sure that he or she is disinherited in one way or another. Vicious gossip about the eldest may make the rounds. The children of the eldest siblings are often gossiped about and/or exiled as well.

Whenever I hear about incest between siblings, I find that, at least among my patients, parental neglect is nearly ubiquitous.  Sometimes the unsupervised children are literally never taught that there is anything wrong with doing this. When the elder sibling grows up, he (or she) becomes totally ashamed of what he had done. Usually the siblings, as adults, will never even discuss what happened. They may go on and act like nothing at all untoward had ever happened. They may avoid one another, but sometimes they may even become quite close!

Patients that grew up in such families often report that everyone in the family stuffs their feelings when in one anothers’ presence, and that no one speaks up when someone else displeases them. Family members are also highly prone to giving one another the “silent treatment” when upset with one another, or cutting off contact for years at a time.

I have often heard patients who were severely neglected as children opine that they would rather that their parents had been abusive rather than neglectful if they had to choose between the two.  At least then they would seem to matter to the family. There are few feelings worse than having your whole family act like you just don’t count for anything and that your very presence is a big bother.  

The Deterioration in Quality and Usefulness of the Notes Written by Psychiatric Nurses

The hospital notes of psychiatric nurses are starting to be as unrevealing of the patient's true condition as the notes by psychiatrists. Both types of notes are relying more and more on useless symptom checklists. As my friend James Woods observed, using a symptom checklist to make a diagnosis is only slightly more accurate than throwing darts at a dartboard - blindfolded.

Whenever a psychiatrist sees a new patient who had been treated by another clinician in the past, it is usually standard operating procedure for the doctor to obtain any prior medical or hospital records that pertain to that patient’s case. However, an ethical psychiatrist does not rely completely on another doctor’s diagnosis or treatment, but does his or her own evaluation to form an opinion. 

The previous doctor might have had things completely wrong. The former chairman of the academic department in which I was the residency training director, Dr. Neil Edwards, used to tell residents in training that the evaluation of each patient new to a clinician should take into account two different possibilities: first, that any prior clinician was competent, thorough and correct. Second, that the prior clinician was none of these things. 

In order to judge the diagnosis made by a mental health professional from the medical records, there has to be more than just a diagnosis on the chart or a quick “mental status” exam from one or two points in time. There has to be a narrative description of the patient. Particularly in a psychiatric hospital setting, there should also be a description somewhere in the chart of the patient’s ongoing behavior on the ward, particularly when the patient is not aware that he or she is being observed, and any major consistent changes in that behavior over time as treatment progresses.

To understand why this is important, let me relay some personal experience. I worked for a time in the main psychiatric emergency room in Memphis, from which many patients were referred for psychiatric hospitalization. After having evaluated a patient in the ER, I would later see the same patient in the hospital on weekends, when I was covering a service for the doctors who were in charge of the patient in the new setting. I would review the patient’s chart for the events and subsequent evaluations that had occurred since admission. One thing I witnessed time and time again – and not just with trainees but with the attending faculty as well – was quite striking. 

In the ER, some patients looked very depressed and showed all the signs (observed characteristics) and complained of all of the symptoms of clinical major depressive disorder. Their movements and speech were slow (psychomotor retardation), and they complained of chronic and persistent changes in appetite, sleep, pleasure, energy, and concentration. Since the patient seemed to meet all of the necessary DSM criteria, the diagnosis of major depressive disorder was therefore made by my resident, and I concurred.

However, in many cases in which I saw the patient in the hospital the very next day, or heard a description of the patient’s behavior on the ward by the nurses on the day following admission, an entirely different picture emerged. The patient was observed to be actively socializing with other patients, friendly and talkative on approach, speaking with normal rate and volume, sleeping on hourly bed checks (although they often had been given a sedative), and eating 100% of served meals!

One major characteristic that distinguishes true major depressive disorder from other types of depression is that its symptoms do not evaporate overnight, nor do they disappear merely because of a change of venue for the patient. They persist and are present in all environmental contexts. They can get to the point where a patient could win the lottery but not crack a smile. If symptoms change radically with a change in venue, then the primary problem for the patient resides in the venue, not in his or her mental disorder.

Clearly, everyone’s initial diagnostic impression of these patients – including my own – was incorrect. 

Yet surprisingly, the patients’ diagnosis was almost never changed during the entire course of their hospitalization. Their admission and discharge diagnoses were identical. Furthermore, they had been given treatments that patients who actually had major depression would be given.

Were my observations of this phenomenon biased in some way? Perhaps not changing a diagnosis in the light of new and conflicting information was something peculiar to doctors practicing in academic settings or only those practicing in Memphis, the city in which I was located. Possible, but not likely. How do I know?  Well, in over 30 years of practice, I have had the opportunity to review medical records of patients who had been psychiatrically hospitalized all over the United States. 

Nowadays, I often do not even bother to even send for hospital records, for they have become next to worthless for understanding a patient's condition. In the doctor’s initial evaluation, there would be no information about the time course, pervasiveness, or persistence of any symptom the patient was alleged to have had. There might be a "description" of symptoms that would consist of meaningless terms such as  “paranoid” or “suicidal” without any explanation of what the term meant as applied to the particular patient, or the context in which it occurred. Did “paranoid” mean delusional, or merely distrustful? No information.

With electronic medical records, I often have access to the notes and evaluations of several previous clinicians. Often no “target symptoms “ are described when a patient is put on a medication, and there is no information later on about what, if any, symptoms, had gone away in response to treatment. No way to know if the patient should have stayed on the medication. Sometimes the meds would be changed, but no reasons would be given for doing so. Did it not work? Or were there intolerable side effects? Or what?

With hospital records, I used to overcome the problem of physicians’ notes lacking any indication of how the patient was behaving on the ward by looking at the nurses’ notes. They used to actually describe such things. The patient might be noted the day after admission to eat, say, 100% of meals, be up and about socializing on the ward, sleeping on one hour bed checks, and pleasant and appropriate on approach.  If such a patient had been diagnosed as major depression or manic by the doctor the day before, I would know that this diagnosis was incorrect.

Imagine my reaction when I recently learned that the major local psychiatric hospital in my area, which is a haven for manufacturing bipolar disorder diagnoses where none exist, was instructing its nursing staff on what and what not to include in its nursing notes. I thought I’d better take a look at them to see what was being included and what was not.

It was far worse than I thought. There were very few narrative nurses notes at all! The main part of the nurses' notes consist of  a checklist which basically completely omitted the type of information I was looking for.

I asked a patient about it. She told me that the nurses would line up all the patients on their ward at certain times of day, take their blood pressures and other vital signs, and ask them if they were suicidal or not. The patient told me that the nurses spent almost zero time observing them on the wards!

I really had to look at even the checklists very carefully to glean anything about how the patient was behaving. Another patient was diagnosed as bipolar, but even on the checklist, the patient's energy was marked normal, affect was marked appropriate, and mood was checked "euthymic" (normal). Bipolar, my ass.

There was also a separate sheet with observations allegedly made every 15 minutes, which of course was inconsistent with what my other patient told me about how often they were closely observed. The patient's behavior on the sheet was again not a narrative description but a number with each digit defined so generally as to be diagnostically meaningless.  Even then, this patient was noted to be sleeping throughout the entire night.

To be fair, there were some narrative notes scribbled on the back of these checklists, often written by a psychiatric technician and not a nurse. Many were illegible, and they contained fairly minimal information. Even so, an allegedly bipolar patient was described as "isolating to room frequently."  [How frequently? Why? In this case the patient later told me that there was a specific reason for going to her room that had nothing to do with a mood disorder], "Pleasant mood, appetite good," and "no distress noted." [Bipolar? Really??]

What is the hospital trying to hide? You can bet that somehow limiting the validity of the information on the patients' charts helps them to maximize their reimbursements from insurance companies - perhaps hiding the fact that they want their doctors to diagnose patients with something serious rather than something the insurance companies might question. Patient welfare be damned. 

Book Review: "High Price" by Dr. Carl Hart: A Life and the Lies in Drug Abuse Research

For a long time I have been critical about conclusions drawn from animal experiments which purported to be models for addictive behavior with drugs in humans. In particular, I got annoyed hearing over and over about how rats and rhesus monkeys would press levers to get cocaine, heroin, or methamphetamine compulsively, even until they died, choosing drugs over even food and water. These experiments were touted  incessantly by so-called experts. As I mentioned in a previous post, the head of the National Institute for Drug Abuse, Dr. Nora Volkov, even had the nerve to say that rats and humans could have the same phenotype!

My usual response to this was that rats and monkeys do not know about the damage the drugs might do to them, but that humans do, and that makes the comparison ridiculous if not completely preposterous. Furthermore, if a monkey experienced the “crash” that followed stopping cocaine or meth, it would not know that the crash was due to the drug, only that the drug stopped the crash.  And scientists even STILL have had no luck in finding rats who hide bottles of alcohol.

As it turns out, these points, while probably valid, are only minor considerations in determining the lessons to be learned from these animal studies. A far bigger issue was that the experiments were not even accurately or honestly described by those touting them. In an outstanding new book called High Price by African-American neurospsychologist Carl Hart, a faculty member at Columbia University, the author points out that descriptions of the environments in which the animals were kept were completely missing from the descripions, but that environmental factors were key in determining animal drug use behavior.

Dr. Carl Hart

The animals in these experiments were essentially kept in solitary confinement, as they had throughout most of their lives, and had nothing else to do but push the lever!  If they were instead placed in an enriched environment with alternatie activities available and other animals with which to socialize, their “drug-seeking” behavior changed drastically.

A series of experiments that the drug warriors don't want you to know about were conducted in the 1970s, and known as Rat Park. Researchers allowed two groups of rats to self-administer morphine. They housed the first group in stark cages, one rat to a cage. They placed the second group in an “enriched environment,” which offered opportunities to burrow, play, and copulate. The isolated rats drank 20 times more morphine-laced sugar water than those enjoying the Rat Park. These results have been reproduced using both cocaine and amphetamine.

Dr. Hart points out that if you were held in solitary confinement with just one movie to watch, you might watch it over and over. That would not prove that the movie itself was addictive!  In people, when they have appealing alternatives, they often do not choose to take drugs in a self-destructive manner.

Add to the mix of misinformation about drug abuse is the unheralded but monumental effect of racism on both drug use and the prevailing ideas about it.  Legal bans on certain drugs (and not others) were legislated after widespread reporting of highly exaggerated horror stories about drug use by a despised minority:  crack cocaine by Blacks, marijuana by Blacks and Mexicans, methamphetamines by toothless "poor white trash" in Appalachia, and opium by Chinese railway workers. No one was immune from these cultural influences and myths, including the minorities themselves. The Black Caucus in the United States Congress was, originally, solidly behind the huge and unfair differences in the length of jail sentences for people convicted of using crack vs. powdered cocaine, the effects of which drugs are physiologically identical.

Some facts:  The problems in the black urban community attributed to crack were already prevalent well before crack was even introduced. The vast majority of illegal drug users do not become addicted or even psychologically dependent on the drug. Among addicts, half are employed full time. Violent convicts in jails are less likely to abuse drugs than other prisoners. The vast majority of homicides do not involved drug use, and alcohol is probably the worst offender among those that do. Dealing crack is only about as profitable as working at McDonalds for low level dealers. Few people who abuse drugs take only one drug, yet there are very few studies of the effects of combinations of drugs. Self reports from addicts who are asked about their cravings for the drugs do not predict whether or not an addict in recovery will relapse.

Adderall and Methamphetamine are nearly identical molecules with identical effects, yet drug manufacturers go out of their way to say that those children treated with stimulants for “ADHD” are no more likely to go on to abuse drugs than anyone else.  Of course, since their drugs are already being legally provided to them by physicians, they have no need to obtain them from illegal sources, which is one of the measures the experts use to measure drug abuse!

This kind of circular reasoning in the literature abounds. In a series of experiments with rhesus monkeys, Dr. Hart reports, “…researchers found that the animals’ choice to use cocaine is reduced to the size of the food reward they are offered as an alternative.” People are now using this data to claim that junk food is as addictive as cocaine, when initially cocaine was claimed to be “…especially addictive because animals preferred  it to food when hungry.” (p.93).

The book by Dr. Hart is especially eye opening because it combines discussions of this sort of pseudoscience with the author’s explorations about his own personal story. As an African-American having grown up in an inner city in which many of his friends and relatives did poorly and got into drugs and crime, he asks himself why he not only escaped this but became an Ivy League professor and an expert. The experiences of this black man in America shines a bright light on the real causes of self destructive behavior. It is not drugs.

The following graphic is not discussed in the book, but, with what we know about the havoc that a felony conviction and hanging out with convicts for months or years can create in the lives of young men, it is clear that far more harm is inflicted on drug users by the laws against drug use than by the drugs themselves.

By the way, do you know how to abuse drugs? You hold them in your hand and scream at them, “You worthless pile of sh*t!  You call that a buzz?? You suck!” You then throw them to the ground and stomp on them. 

Yeah, it’s the self that’s being abused by addicts, not the drugs. 

You owe it yourself to read this highly engrossing and informative book.

Yet Another Pharma Company Pays Huge Fine for Misleading Marketing

On my post of May 8, 2012, I reported that, after a rash of huge United States Justice Department fines against various large drug companies for deceptive marketing of drugs used in bipolar disorder and other psychiatric conditions, two states picked up the gauntlet. The states of South Carolina and Arkansas fined Ortho-McNeil-Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson, for overstating the effectiveness and minimizing the risks of their antipsychotic medication Risperdal.

The company responsible for this deceptive advertising was one that had somehow escaped the scrutiny of the federal government.

Until now.

There is this from the US Department of Justice. This same company was fined 2.2 billion dollars for misleading and deceptive advertising for this medication. (My posts about this sort of thing are getting just plain routine, and a bit tiresome):

 "WASHINGTON - Global health care giant Johnson & Johnson (J&J) and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider.  The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion....

In a criminal information filed today in the Eastern District of Pennsylvania, the government charged that, from March 3, 2002, through Dec. 31, 2003, Janssen Pharmaceuticals Inc., a J&J subsidiary, introduced the antipsychotic drug Risperdal into interstate commerce for an unapproved use, rendering the product misbranded.  For most of this time period, Risperdal was approved only to treat schizophrenia.  The information alleges that Janssen’s sales representatives promoted Risperdal to physicians and other prescribers who treated elderly dementia patients by urging the prescribers to use Risperdal to treat symptoms such as anxiety, agitation, depression, hostility and confusion.  The information alleges that the company created written sales aids for use by Janssen’s ElderCare sales force that emphasized symptoms and minimized any mention of the FDA-approved use, treatment of schizophrenia.  The company also provided incentives for off-label promotion and intended use by basing sales representatives’ bonuses on total sales of Risperdal in their sales areas, not just sales for FDA-approved uses.  

In a plea agreement resolving these charges, Janssen admitted that it promoted Risperdal to health care providers for treatment of psychotic symptoms and associated behavioral disturbances exhibited by elderly, non-schizophrenic dementia patients.  Under the terms of the plea agreement, Janssen will pay a total of $400 million, including a criminal fine of $334 million and forfeiture of $66 million.  Janssen’s guilty plea will not be final until accepted by the U.S. District Court...

In a related civil complaint filed today in the Eastern District of Pennsylvania, the United States alleges that Janssen marketed Risperdal to control the behaviors and conduct of the nation’s most vulnerable patients: elderly nursing home residents, children and individuals with mental disabilities.  The government alleges that J&J and Janssen caused false claims to be submitted to federal health care programs by promoting Risperdal for off-label uses that federal health care programs did not cover, making false and misleading statements about the safety and efficacy of Risperdal and paying kickbacks to physicians to prescribe Risperdal...

The complaint also alleges that Janssen knew that patients taking Risperdal had an increased risk of developing diabetes, but nonetheless promoted Risperdal as “uncompromised by safety concerns (does not cause diabetes).”  When Janssen received the initial results of studies indicating that Risperdal posed the same diabetes risk as other antipsychotics, the complaint alleges that the company retained outside consultants to re-analyze the study results and ultimately published articles stating that Risperdal was actually associated with a lower risk of developing diabetes."

So far, these huge fines have not seemed to have done a whole lot in discouraging this practice. The companies more than recoup the costs.

Pharma Still Up to its Old Tricks

It looks as though big Pharma is still up to one of its most disturbing practices: not publishing or making public studies that show that its products might be ineffective. As described by my colleague Peter Parry later in this post, we had thought this problem was successfully addressed back in 2010.  

Apparently not.

And do not think this problem is unique to psychiatric medications. 

Of course, as I have pointed out several times in this blog, recruitment and assessment of subjects for many research studies these days has become so warped by financial incentives that many of the studies, published or not, are not worth the paper they are printed on to begin with. 

And some studies are purposely designed to mislead readers into believing that certain generic drugs, particularly antidepressants, are not effective when in fact, when used properly for the right patients, they are among the most effective drugs in all of medicine. But that's a 'hole 'nuther issue.

To get back to the issue at hand:

From Medscape, 10/29/13: 

An analysis of nearly 600 registered clinical trials published online October 29 in BMJ has shown that 29% remained unpublished 5 years after completion, that no results were available in ClinicalTrials.gov for three fourths of those unpublished trials, and that industry-funded trials were nearly twice as likely to go unreported as studies that had not received industry funding.

Previous studies have shown that published trials contain less than half of the patient-outcomes data contained in company-controlled documents.

Dr. Jones and colleagues from the University of North Carolina, Chapel Hill, conducted a cross-sectional analysis of trials that had at least 500 participants and had been prospectively registered with Clinical Trials.gov and completed before January 2009. 

Their analysis included 585 registered trials, 171 of which (29%) remained unpublished. These unpublished studies included nearly 300,000 participants.

"By focusing our investigation on studies with at least 500 participants, we greatly limited the possibility that non-publication of trials in this cohort was due to rejection of manuscripts by journals or a lack of time or interest on the part of investigators or sponsors," the authors write.

The non-publication rate was 32% for industry-funded trials and 18% for those without industry funding (P = .003), and 78% of the unpublished trials also had no reported data in ClinicalTrials.gov.

From Peter Parry (on the webpage TheConversation.Edu.Au):

Dr. Peter Parry

A large proportion of drug trials, particularly those sponsored by pharmaceutical companies, never get published, skewing our picture of drugs' effectiveness and safety.

Research published in 2010 showed results unfavorable to sponsored drugs are less likely to be published, or selectively published to put a favorable spin on poor results.  And internal pharmaceutical industry documents released from court cases show concealment of data is a widespread practice.

A colleague and I assessed such documents about psychiatric medications from five pharmaceutical companies. The papers suggested widespread overstatement of benefits and understatement of adverse effects. Other researchers have found similar problems with different drugs.

In response, some medical journals voluntarily agreed to publish only studies registered on a website of the US National Institutes of Health, ClinicalTrials.gov. At least studies with unfavorable results would not be buried by drug companies. But the BMJ article confirms that many registered studies still don’t get published.

The AllTrials initiative aims to make the (de-identified) results and methodology of drug trials available to independent researchers so journals can publish in-depth articles based on all of the full data.

In 11 months, the campaign’s petition has gathered over 59,000 individual signatories and over 400 medical and health-care organizations. These include many British medical colleges and learned academic medical science institutions, such as the Cochrane Collaboration and the British National Institute for Health and Clinical Excellence (NICE).

Although the campaign is progressing slower outside the United Kingdom, it is managing to get some traction internationally.

The World Association of Medical Editors (WAME), the South African Medical Research Council and the Canadian Agency for Drugs and Technology in Health have signed.

Maybe there is still hope this problem can be rectified.

Guest Post: Addictions and Development

Today's guest post is by Emma Haylett. She decribes growing up with an alcoholic father who literally tried to recruit her as his drinking buddy, and in the process put her smack dab in the middle (triangulation) of her parents' relationship. This may be a telling example of someone in the role of go-between.

A Revelation

My father bought me my first 6-pack of beer. I was only 14 at the time and drank it behind closed doors, away from him and the rest of my family. It was a late summer night and I remember my mother was already hidden away in her room, lights off, TV on such a low volume like she was whispering with ghosts. Dad sat in a broken recliner watching western violence, occasionally calling my name to come drink with him. Instead, I wrote. I started writing before I popped the first cap and continued to do so after all of them were empty and stagnant around me.

I knew the other kids at my school drank. I knew my dad drank. I watched him every day, but what I didn’t realize was the problem he held. Within the next two hours, I was dizzy and tired. The spoken words of my father were surrounded in quotation marks intermittently written down the page, phonetically spelled out: “Em-uhh,” “ehmm,” and “c’mon to the livin’ room, now.” 

As my state of clarity became more and more unclear, my dad’s stayed exactly the same. I didn’t know he was permanently inebriated until pouring over my notes the next morning. This revelation became something of an alcohol abuse study for years.

My mother never noticed the extra beer my father bought. I think she always assumed Dad was going to drink them, and it was a fair enough assumption. As he pressured me to drink them, I would sip slowly and watch him become more intolerable by the bottle. It didn’t taste good and I don’t remember it feeling good either. 

His speech slurred to the point of intelligibility and his breath was something similar to a laboratory experiment gone wrong. His actions embarrassed me – he would yell at the television if a star delivered a line poorly, and wrap his arm around my shoulder to tell me how to buy liquor underage. Whenever my mother entered the room, his face became tired and uninterested.

One evening, after Dad was snoring deeply in the chair, my mother sat me down and asked me if I drank with him. Of course I didn’t lie – I told her he would give me a few bottles and we would watch TV together. She told me Dad wasn’t healthy and that what he was drinking wasn’t, either. She told me he was always cracking cans since he was about my age, partying much too hard with his friends and family. I wasn’t old enough, she very sternly told me, “and your dad’s decisions reflect poorly upon this family.” I stopped drinking with him after that night.

Family Treatment

Dad was kinder in the early hours of the day and progressively became more incoherent and rude towards the time he usually passed out in the recliner. I come to realize, from lengthy trial-and-error experiments, that the trick to getting lunch money, permission to go out on school nights, or even a small favor was asking him in the mornings after his first coffee with a whiskey cream substitute. 

My mother took the opposite route and, when she thought I wasn’t around, suggested rehab programs later in the evenings, or else, she threatened, she would leave…again and again. But she never did. Their relationship became empty threats with the two of them screaming about whose turn it was to buy essential toiletries with the little money we had, and who was going to raise their daughter standing behind them unnoticed.

There was more hidden behind my father’s alcohol addiction than what was obvious: the empty bottles clacking together as he put another one down was always accompanied by false affection when we had father-daughter talks around the dining room table late at night about being a responsible adult, trust, and his image of love. I learned that being responsible was saving a bit of grocery money for a tall bottle of cheap alcohol. Trust was believing him when he said, “Just one more,” and love was “don’t tell your mother” followed by a bribe.  

Promises to attend my school-sponsored activities came to a screeching halt as the more dangerous drugs became the better part of him. I once found him asleep in the truck idling in the driveway with the windows down and a burnt cigarette between his still fingers. The long stem of ash flaked away as I shook him to remind him that he was supposed to take me to school.

Emotional Detox

I lied to my friends. I lied to my teachers, and I lied to myself - for years. It goes without saying that I don’t trust long or often. I had a hard time believing my ex-fiancé Jake was going for a quick run to the gas station without bringing home a brown paper sack around a bottle or plastic baggie of some substance. I am reminded of being alone when my new neighbor’s empty beer cans crash and echo against each other as she pushes her trash bins to the curb every Thursday morning. I am still angry at my mother who should have tried harder to get my father some help.

I always wished he would have even considered alcohol rehab. I firmly believe our family life could have been different, saved even, with detox and therapy. As an adult, I hesitate to show affection and honesty. I have daylight visions of my father wrecking the truck. I lose hours of sleep over the conversations I should have had with Jake about trust and what it means to be loved without stipulations.

Looking back, it’s hard to know what it is I was feeling. From adulthood, it is easy to know that my father was using me as a crutch, as a tool with which to hurt my mother. And I dutifully played the part of loyal daughter to both of them. I was a substitute, in many ways, for their relationship—an embodiment of the good in my father as my mother saw him, a (albeit young) drinker still capable of offering love - and so she ignored it. For my father, I was a female who served as his caretaker and confidant, a secret-keeper who acted without judgment, an enabler. While my father was dependent upon alcohol, I was simply (or not so simply) using it—more on that here. This was my first experience as an enabler too.

I do remember feeling trapped in between them and, because they were my parents equally, wanting to please both. If I could do it simultaneously, even in secret, it felt like a win. I didn’t like the taste or feel of alcohol, but I also didn’t like the way my father breathed my name until I came out. For me, this drinking was easier, especially since I never outright lied to my mother. Like my father, I had my justifications.

Therapy

I’ve learned that addiction is better treated as a disease. With a non 12-step program, doctors treat addicts with proper medical treatment as you would any other chronic medical illness. Working with addicts in this program has taught me that sometimes you can’t rely on having faith or attending self-help meetings. Sometimes real help (however you find useful to define it) is necessary. 

Addicts can come to an understanding of trust and commitment, as well as formulating a self-betterment plan that is supported by people like me. I provide the guidance and encouragement as well as sensitivity to the issue.

My father would always get upset if the word “addiction” was even quietly muttered.

I realize what it is like to be an addict. I watched and recorded one my entire life. To approach the issue with proper intelligence and caution is critical – to provide them with real courage and motivation rather than standing idly by will push the addict towards getting the appropriate help and the chance of staying healthy will greaten. It’s a very rewarding opportunity to be there for somebody and to see them succeed.

I help myself by helping people overcome these dangerous addictions. I help them make that sensitive reconnection to their family and children. There is always hope that they can raise their kids to live without being exposed to the fear and emotional emptiness that that I hold inside and that is so overwhelming. Getting help can change more than one life. That first step is always the hardest, but I know in my heart of hearts it can make a difference.

Author Bio: Emma Haylett finds comfort in writing. When she’s not helping coordinate non 12 step recovery programs for addicts and their families, you can find her watching terrible made-for-TV movies.

Part 5 of Dr. Allen's Discussion About Borderline Personality Disorder - The Earth Needs Rebels Show on Orion Talk Radio

Part 5 of my discussion of borderline personality disorder on Free Thinking Voice - The Earth Needs Rebels internet radio show was on live Tuesday, November 12, from 12-2 PM U.S. Central Time, and is now found on their website.    

Here is the link to the downloaded broadcast: http://oriontalkradio.com/archives.htm.  Click on "down" and not on "listen."  The date and times posted for the broadcast: Tuesday, November 12, at 1:05 and 2:05 PM.