GlaxoSmithKline Guilty, Fined $3B for Paxil, Wellbutrin Marketing

2 July 2012

By John M. Grohol, PsyD
Founder & Editor-in-Chief

In the largest health care fraud settlement ever, GlaxoSmithKline has agreed to pay the whopping sum of $3 billion, the U.S. Justice Department announced earlier today. The reason?

GlaxoSmithKline was caught marketing two popular antidepressant drugs — Paxil and Wellbutrin — for populations and indications they were never approved for.

In the U.S., the Food and Drug Administration (FDA) must approve all prescription medication uses and who they can be marketed to, based upon scientific studies the pharmaceutical must develop, fund and publish. Pharmaceutical companies then have to ask for permission to add those uses or populations to the drug’s existing approval.

Many drug companies, including GlaxoSmithKline (GSK), have sought to cut corners in getting these additional formal approvals, because all of that additional research costs time, money and effort on their part. So in the past, they’ve “soft marketed” these drugs for these additional uses through the salespeople who try and sell the drug to individual psychiatrists and physicians.

Perhaps, finally, drug companies will get the message. You may get away with such marketing practices for awhile, but eventually some whistleblower is going to (thankfully) turn you in.

So what did GSK do, exactly? Three things:

Prosecutors say GSK encouraged use of Paxil for children although it was not approved for anyone under 18.

The company also promoted Wellbutrin for uses besides major depressive disorder, its only approved use.

They say that between 2001 and 2007 GSK failed to report on two studies of the cardiovascular safety of Avandia, a diabetes drug.

Sadly, the fine is actually less than the company thought it would be:

Glaxo is pleading guilty to these violations of FDA regulations, which are misdemeanors. It has set aside $3.5 billion to cover the cost of the fines and other penalties related to the government’s seven-year probe of the company’s marketing practices for Paxil, Wellbutrin and Avandia, three of its blockbuster drugs.

And overall, we have to put the fine into some sort of context.

GSK had $11.7 billion in Paxil sales 1997-2006, according to data the company supplied as a part of a lawsuit. And that was just in the U.S. for a nine-year period.

It’s likely that GSK realized similar sales numbers for Wellbutrin during the years it was under patent.

According to litigation experts, the company has paid out more than $2 billion prior to this settlement to resolve a series of patient-filed lawsuits over Paxil.

Combined with the $3 billion fine, it still doesn’t appear to make GSK feel any real pain, because the company still managed to make billions of dollars from the sales of all three drugs.

All we can do is hope that such fines don’t make drug companies simply look for more clever ways to hide such marketing efforts, but that that they quit them altogether. And if they do the math, they may find it’s actually cheaper to do the additional research and run it through the FDA’s regulatory process for additional use and population approvals, than it is to try and sneak these things under the table through their sales and marketing departments.

And pharmaceutical companies wonder why they have such a reputation problem…

Read the full story: Drug giant pleads guilty, fined $3B for drug marketing

http://psychcentral.com/blog/archives/2012/07/02/glaxosmithkline-guilty-fined-3b-for-paxil-wellbutrin-marketing/

Equine Therapy: A Must See Video

By Claire Dorotik, LMFT

Sometimes, the bond between horses and people is best understood through demonstration; describing the communication that can exist between a horse and his partner with only words leaving something lacking.

And sometimes a true magician comes along, and there seems to be a new language that emerges between horse and man. One such person is Klaus Hempling.

Klaus coined the term “magic lungeing,” and believes that the preparation of the horse before it’s ridden is very important. However, as you can see in the video, much more happens between Klaus and his horse than simply preparation.

Hopefully, through understanding horses more clearly, we can also come to better understand ourselves, so that we too may communicate as seamlessly as Klaus and his magnificent stallion.




http://blogs.psychcentral.com/equine-therapy/2012/07/equine-therapy-a-must-see-video/

Common Signs of Someone Who May be Suicidal

By John M. Grohol, PsyD
Founder & Editor-in-Chief

According to government data, 70% of people who commit suicide tell someone about their plans, or give some other type of warning signs. Over 30,000 Americans die each year due to suicide, but over 800,000 Americans attempt suicide. While women attempt suicide three times more than men, men are nearly four times more likely to be successful.

You may be in a position to help someone get help before they take the one action that cannot be taken back.

Warning signs of suicide are not difficult to spot, but professionals differentiate between someone who simply has a passing thought of suicide or ending his or her own life, and someone who is more serious and has a definite plan. You don’t have to know how serious a person is in order to help them, though.

Friends and family who are close to an individual are in the best position to spot these warning signs. Often times people feel helpless in dealing with someone who is depressed or suicidal. Usually it is helpful to encourage the person to seek professional mental health help from a therapist, psychiatrist, school counselor, or even telling their family doctor about their feelings. Your friend or loved one needs to know you’re there for them, that you care and you will support them no matter what.

Remember, depression is a treatable mental disorder, it’s not something you can “catch” or a sign of personal weakness.

Some Suicide Warning Signs

Have you ever heard someone say two or more of the following?

• Life isn’t worth living
• My family (or friends or girlfriend/boyfriend) would be better off without me
• Next time I’ll take enough pills to do the job right
• Take my prized collection or valuables — I don’t need this stuff anymore
• Don’t worry, I won’t be around to deal with that
• You’ll be sorry when I’m gone
• I won’t be in your way much longer
• I just can’t deal with everything — life’s too hard
• I won’t be a burden much longer
• Nobody understands me — nobody feels the way I do
• There’s nothing I can do to make it better
• I’d be better off dead
• I feel like there is no way out
• You’d be better off without me

Have you noticed them doing one or more of the following activities?

• Getting affairs in order (paying off debts, changing a will)
• Giving away articles of either personal or monetary value
• Signs of planning a suicide such as obtaining a weapon or writing a suicide note

Suicide is one of the most serious symptoms of someone who is suffering from severe depression. Common signs of depression include:

• Depressed or sad mood (e.g., feeling “blue” or “down in the dumps”)
• A change in the person’s sleeping patterns (e.g., sleeping too much or too little, or having difficulty sleeping the night through)
• A significant change in the person’s weight or appetite
• Speaking and/or moving with unusual speed or slowness
• Loss of interest or pleasure in usual activities (e.g., hobbies, outdoor activities, hanging around with friends)
• Withdrawal from family and friends
• Fatigue or loss of energy
• Diminished ability to think or concentrate, slowed thinking or indecisiveness
• Feelings of worthlessness, self-reproach, or guilt
• Thoughts of death, suicide, or wishes to be dead

Sometimes somebody who is trying to cope with depression on their own will be seen turning to things like alcohol or drugs to help ward away the depressive feelings. Others might eat more, watch television for hours on end in bed, and not want to leave their house, apartment or dorm room.
Sometimes a person who is depressed may stop caring about their physical appearance on a regular basis, or whether they shower or brush their teeth.

Typically, people who suffer from serious, clinical depression feel depressed for weeks or months on end, so someone who’s just having a particularly rough or stressful week (because of school demands, relationship issues, work issues, etc.) may not be suffering from clinical depression.

http://psychcentral.com/blog/archives/2007/10/08/common-signs-of-someone-who-may-be-suicidal/

Sleep Deprivation Affects Immune System Like Physical Stress

By Janice WoodAssociate News Editor
Reviewed by John M. Grohol, Psy.D. on July 1, 2012


Sleep deprivation jolts the immune system into action in the same type of immediate response shown during exposure to physical stress, according to a new study.

Researchers in the Netherlands and United Kingdom compared the white blood cell counts of 15 healthy young men under normal and severely sleep-deprived conditions.

The greatest changes were seen in the white blood cells known as granulocytes, which showed a loss of day-night rhythmicity, along with increased numbers, particularly at night, the researchers report.

Previous studies have linked sleep deprivation with diseases such as obesity, diabetes and hypertension. Other studies have shown that sleep helps sustain the functioning of the immune system, and that chronic sleep loss is a risk factor for immune system impairment, the researchers note.

For this study, white blood cells were measured from 15 young men following a strict schedule of eight hours of sleep every day for a week. The men were exposed to at least 15 minutes of outdoor light within the first 90 minutes of waking and prohibited from using caffeine, alcohol or medication during the final three days.

All of this was designed to stabilize their circadian clocks and minimize sleep deprivation before the intensive laboratory study, the researchers explain.

After 29 hours of continual wakefulness, the researchers took blood samples from the young men to compare white blood cell counts with the counts found during the normal sleep/wake cycle.

“The granulocytes reacted immediately to the physical stress of sleep loss and directly mirrored the body’s stress response,” said Katrin Ackermann, Ph.D., a postdoctoral researcher at the Eramus MC University Medical Center Rotterdam in the Netherlands and the study’s lead author.

“Future research will reveal the molecular mechanisms behind this immediate stress response and elucidate its role in the development of diseases associated with chronic sleep loss,” she said.

“If confirmed with more data, this will have implications for clinical practice and for professions associated with long-term sleep loss, such as rotating shift work.”

Source: American Academy of Sleep Medicine

http://psychcentral.com/news/2012/07/01/sleep-deprivation-affects-immune-system-like-physical-stress/40874.html