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.

Themes of This Blog Seen In Newspaper Advice Columns – Part II

This is the second in series of posts showing how several of the issues I discuss in this blog show up in letters to newspaper advice columnists. Advice columnists must bring us problems that resonate with a fairly wide readership, and they therefore provide us with another source of information about human behavior and cultural trends.

I follow Jeanne Phillips (Dear Abby), Carolyn Hax, Amy Dickinson (Ask Amy), and Marcy Sugar & Kathy Mitchell (Annie’s Mailbox).

I will highlight each theme with a title preceding each letter to the columnist that I've reproduced, reflecting the blog subject that seems to be discussed. The title will also be a link to a related post. I am not including the columnist’s responses to the letters. 

"In relationships, if you always do what you always did, you'll always get what you always got." ~ Amy Dickinson.

Whenever a family member has somewhat compulsively behaved in a certain manner for a very long time, and then decides to change, the change often does not go over well with the rest of the family. The others seem determined to force the changer to go back to his or her old ways. 

In this post, I am emphasizing the above process rather than the particular role described in these letters, which I have not previously discussed directly as a separate entity. In the following three letters, the writers all had served in various incarnations of the same role, and complain about the reactions of the rest of their families when circumstances changed. The role might be called the “family support person,” or in a more extreme form, the “family servant” or even “the enabler.”

6/7/13.  Dear Carolyn: I’ve always been the one in my family to give whenever possible. When I went to college, I took on student loans so my sister wouldn’t have to. A few years later, when her car died, I purchased a new one and gave her mine. When family needed help, I was always there. Now I’m trying to purchase a house, and no one seems the least bit interested in helping me. I swallowed my pride and asked for financial assistance, even if it was a “loan,” and was told tough toenails. Would it be wrong for me to cut my family out of my life? I feel as if I was the great son whenever I went out of my way to help, but now I’m just some annoyance. - Always the Giver

6/18/13. Dear Amy: I've spent most of my life being a support system for various friends and relatives through one crisis or another. I've always been proud of the fact that I'm someone they can rely on when they need to. Recently, I learned that I may have a debilitating disease for which there is no cure. No firm diagnosis has been reached, but at this point it doesn't look great. Since I received the last batch of test results, I have witnessed my friends and relatives pull away from me, dismiss my symptoms and change the subject if I bring it up. I understand that everyone has their own lives and problems, but I desperately need some support right now. — Lost

June 24, 2013.  Dear Annie: My husband and I both work 18-hour days at a hospital. When we get home, we are exhausted. Since our schedules are irregular, however, our siblings seem to think it means we are always available for free babysitting. My husband's sister (a stay-at-home mom) is forever dropping off her toddler, saying she needs to "de-stress." She never calls ahead. We've tried locking the door, but she has a key. My brother has dropped off his young sons multiple times without warning and with no indication of when he'd be back. He stopped when I told him I was going to start charging him $12.50 an hour.  

The last straw was when my oldest brother's wife arrived one weekend in a van with seven little girls and stated that these kids were staying overnight with us because she and her girlfriend were going to a spa. I was just getting off a 24-hour shift, and I told her politely that since she hadn't checked with me beforehand, she'd have to make other arrangements because I was too exhausted to care for her girls and those of her friend. She became angry and told my nieces that I don't love them. Her girlfriend, whom I had never met, screamed at me from the passenger window. After they left, I got nasty phone calls from my brother and parents. The friend sent me an itemized bill and asked that I reimburse her for the spa trip they missed. Instead of responding, my husband and I sent our family members an email outlining that we love them and our nieces and nephews, but we would no longer be available for babysitting unless it was an emergency. We apologized for being rude or for causing them any trouble. The email was much kinder and more polite than they deserved, but we hoped it would allow us to start over. It was not received well. Currently, the only person speaking to us is my father-in-law. We considered moving in order to have boundaries, but I resent being forced out of a house I love.  I miss my family. What can we do? — Not the Nanny

Your Spouse’s Secret Mission 

Wherein one’s spouse plays the villain to take the heat off a husband or wife who cannot stand up to his or her own family.

8/19/12. Dear Annie: My daughter-in-law tends to go to her family. She says she is uncomfortable with my son's side. She has been rude to us since she married my son, and she controls him. She threatens him if he does not do what she wants. My daughter had a fight with my daughter-in-law four years ago, and I just woke up to the fact that my daughter-in-law blames us for my daughter's actions. My husband and I tried therapy with my son and daughter-in-law, but it made things worse. I left, saying that I am not happy with either of them and I just want to see my grandchildren. My son said that if I don't continue with therapy, I won't see the kids again. They are using the children as weapons to control us. I told her she didn't like us from Day One. She told me she doesn't trust me. My new granddaughter had a baptism, and my daughter-in-law told us it was an occasion only for her family. We were insulted and hurt. I'm thinking of going to court and suing for grandparents' rights. — Trustworthy

Tag, you’re it 

Despite the protestations of heritability study authors across the universe, parents do not treat all of their children the same.

9/21/13.  Dear Annie: I'd like to add my two cents about whether parents treat their children the same. Mom, Sis and I live equidistant from one another. Sis still lives near the place where we grew up. Mom moved to a warmer climate. We call each other every weekend to catch up and stay in touch. Sis and I fly to visit Mom about once a year. Mom visits Sis and her family a few times a year. But despite the many invitations I have extended, she will not visit me. When I had heart surgery five years ago, Mom did not come. When I was hospitalized for pancreatitis, Mom did not come. Of the 25 stage plays I've appeared in, Mom came to see exactly one. She will never see the home my wife and I remodeled. It seems the things that are important to me don't matter much to her. I suppose there is a certain amount of validity in her excuse that there's nothing that interests her in my city, but when we visit our son and his family, we don't care whether there is anything to do. We are simply glad to be with them. Does Mom love me? Certainly. Does she love me as much as my sister? Probably. Does she treat us the same? Judge for yourself. — That's My Lot in Life