The End For European Medicine Regulators?

Image: cientifica.eu


I was sent a link by a reader of Seroxat Sufferers that, if true, could have severe implications for those taking prescription drugs in the UK and rest of Europe.

The website, prescrire.org, is predominantly written in French, however the following has been translated into English.

The post was made on the 1st December, 2009 and, if true, will leave you shocked and stunned at the latest European Commission proposal.

It would appear that they wish to hand over post-marketing monitoring to the pharmaceutical companies, the same pharmaceutical companies that have a history of covering up adverse reactions that harm the sales of their products!

Prescrire writes:

Confronted with this fundamental problem, rather than attack the causes (including inadequate risk evaluation before drugs are approved), the European Commission has proposed a dangerous reform of the pharmacovigilance system. The Commission plans to turn the problem over to the very parties who have a strong direct interest in burying it: pharmaceutical companies.

You can read the article for yourself here

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Paxil Changes Your Personality

Image: api.ning.com

I can't argue with the title to this post. Paxil [Seroxat] does indeed change your personality.

It appears that it changes it for the good, if a recent study is to be believed.

The study, 'Personality Change During Depression Treatment' appeared in the Archives of General Psychiatry - Vol. 66 No. 12, December 2009.

In a nutshell, the study found no significant differences between the two active treatments, the SSRI paroxetine [Paxil/Seroxat] and cognitive behavioral therapy [CBT]. But both paroxetine and the CBT treatment outperformed placebo in changing depression, neuroticism, and extraversion scores significantly. [1]

Peter D. Kramer, the psychiatrist and author of the 1993 book 'Listening to Prozac,' has said that he felt "vindicated" by this newly published study. The LA Times reports that Kramer thought this study might have been funded by the makers of Paxil/Seroxat, GlaxoSmithKline. However, to back up his [vindication] the LA Times reports that the study was funded by Northwestern University initially, and then continued under a pair of grants from the National Institute of Mental Health.

So, all seems well in Peter Kramer's world - he feels vindicated that this study has proved him right.

Let's try not to rain on Kramer's parade here... I prefer the term 'Piss on one's cornflakes.

On Monday December 1st, 2003, Emory University, GlaxoSmithKline, and National Institute of Mental Health Create Partnership announced that they were going to develop new treatments for depression.

Wait a minute... The National Institute of Mental Health?

The same institute that continued the 'Personality Change During Depression Treatment' study?

Yes, you read correct folks.

Strange that Kramer doesn't mention this whilst blowing his own trumpet at his vindication.

We all know of Emory University and their connections with GlaxoSmithKline and Paxil/Seroxat don't we?

Here, Emory researchers found Paxil/Seroxat improved memory and brain structure in people with post traumatic stress disorders.

More worryingly, here, we find that Charles Nemeroff, prominent Emory University psychiatrist, failed to tell the Emory officials about $500,000 he received from GlaxoSmithKline while heading a government-funded research project studying Glaxo drugs.

I think we can safely say there is a conflict of interest here.

But what of The National Institute of Mental Health?

Well, scientists from Emory University School of Medicine, GlaxoSmithKine (GSK), and the National Institute of Mental Health (NIMH) have worked together since 2003 to accelerate the development of drugs to treat depression and other mood disorders. They were funded through a $4.9 million, five-year grant from the National Institutes of Health.

When I hear of Paxil/Seroxat being heralded as this or that, I tend to think there is a conflict of interest. It's a risk vs benefit thing with me you see. I like to weigh up the evidence that is out there and not the evidence we are just told to accept.

Kramer conveniently forgets to mention the on-going partnership between GSK, Emory and the National Institute of Mental Health.

See for yourselves here

Maybe Kramer just didn't know?

Enjoy those cornflakes.


[1] Personality Change During Depression Treatment


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Feds probing Emory, professor on research grants

Source: The Atlanta Journal-Constitution


By CRAIG SCHNEIDER

Federal officials are investigating Emory University and one of its prominent researchers to determine if either misled government agencies about the psychiatrist’s high-paying work with drug companies, officials said.

U.S. Sen. Charles Grassley, who pressed for the investigation, sent a letter Tuesday to the inspector general of the U.S. Department of Health and Human Services outlining his concerns. He said Dr. Charles Nemeroff, an internationaly prominent psychiatrist, may have violated conflict of interest rules surrounding several grants that Emory received from the National Institutes of Health. Grassley’s letter also noted that Emory is required to report such conflicts to the NIH.

The investigation by the inspector general focuses on the concerns addressed in Grassley’s letter, said Jill Kozeny, spokeswoman for Grassley.

The probe also reflects concerns about the way in which Emory handled the reporting of Nemeroff’s earnings from drug companies and his potential conflicts of interest.

Nemeroff, an internationally known expert on depression and former chairman of Emory’s psychiatry department, was a prime target of Grassley’s congressional investigation into whether drug company payments to doctors and academics compromises medical research and scholarship.

Grassley, an Iowa Republican who is the ranking member of the U.S. Senate Finance Committee, released documents last fall indicating that Nemeroff reported little of the money he earned through speeches he delivered for drug companies. He also received payment from drug companies whose products he was evaluating, officials said.

“But I have learned from the NIH that it was generally not aware of Dr. Nemeroff’s conflicts until I made the issue public last fall,” Grassley said in his letter.

Grassley also requested that the probe focus on whether Emory misled the NIH about the nature of Nemeroff’s talks for the drug company GlaxoSmithKline, which produces the antidepressant drug Paxil. Grassley has asserted that these talks were to promote the drug, while Emory has said they were for general education.

The NIH, an arm of the federal health and human services agency, requires universities to report potential conflicts of interest to ensure unbiased research.

Schools that violate the policies can face fines, a freezing of funds and loss of future grants. Overall, the NIH awarded Emory more than $251 million in funding last year — 61 percent of its total research grants.

As a result of its own investigation, Emory in December stripped Nemeroff of his department chairmanship and placed severe restrictions on his activities. Emory found that Nemeroff had violated the university’s policies by not reporting more than $800,000 in income from speeches for GlaxoSmithKline.

Nemeroff could not be reached for comment Thursday, but he has said, according to school officials, that he believed he was following school policy and was not required to report the speaking engagements.

Emory spokesman Ron Sauder said, “Emory has been fully cooperative with the National Institutes of Health and Sen. Grassley, and we will continue to be.”

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

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SKYLAND TRAIL/NEMEROFF & THE ANONYMOUS TIPSTER

Back in November I wrote about Skyland Trail and the connection between them and disgraced psychiatrist, Charles Nemeroff. It prompted a series of comments left by an anonymous tipster. The last comment I had has been kept under wraps as I wanted to give Skyland Trail the right of reply before I posted it.

Here is the anonymous post:

The senior management staff, including Beth Finnerty, President/CEO and Dr. Kotwicki, Medical Director, are certainly missing the mark. I have never seen an organization so void of moral character as Skyland Trail, George West Mental Health Foundation.

Ms. Finnerty is mostly interested in dollars and Dr. Kotwicki on his own career pursuits. Unfortunately it is client care that continues to suffer. The staff turnover is enormous especially since Dr. Kotwicki came on board. The staff is patronized and treated with such disrespect and blame.

Skyland Trail promotes the Recovery Model which is a joke by the way they treat their staff. Their best response it "it is not thier (staff) decision." How can staff grow and develop in this atmosphere. The clinical staff is overworked and under paid. I can't say the same for the business/administrative staff as well as their incompetence.

Please look into the misappropriation of funds and how they handle their cash flow. Is Mark West blind or just snowed by the poor oversight and decision making of Ms. Finnerty.

Because the anonymous tipster was naming names I had to give Skyland Trail the right of reply before I published the comment.

Vice President of External Affairs at Skyland trail, Conni Lombardo, told me, "Unfortunately, we cannot comment on an anonymous posting and more importantly, we believe the accusations in the posting are baseless and unfounded."

I will of course leave this open for debate should the anonymous tipster wish to comment.

Fid

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SKYLAND TRAIL & CHARLES NEMEROFF

Earlier this year I pointed out that disgraced psychiatrist, Charles Nemeroff held key positions at Skyland Trail.

Skyland Trail claim to serve adults with mental illness through innovative and individualized treatment that improves mental, physical and social well being. They also claim to specialize in the following disorders:

• Bipolar

• Depression

• Dual Diagnosis

• Schizophrenia

Millionaire psychiatrist Charles Nemeroff holds the following positions at Skyland Trail:

Board of Directors
Charles B. Nemeroff, M.D., Ph.D.

Professional Advisory Board
Charles Nemeroff, M.D., Ph.D.

National Advisory Board Members
Charles B. Nemeroff, M.D., Ph.D

Since my first post about this I have recieved comments from a former patient at Skyland Trail. It makes harrowing reading and begs the question; What on earth is going on at Skyland Trail, more importantly, why is this disgraced psychiatrist, Charles Nemeroff, part of [what sounds like] a living hell?

I don't know the authenticity of 'A Former Patient' but their comments are worth publishing, if only for others to come forward. I'm sure Sen. Grassley would be interested.

Comments left by 'A Former Patient'

I was a patient at Skyland for two months at the South Residence.

I was viciously retraumatized by the experience, and I was already suffering from severe PTSD.

I won't even go into all the details of what I observed, much less what I heard from patients who were there before me. There aren't words for Skyland Trail... it is a legal torture prison. Some of the shit they did there would have been outlawed at Guantanamo.

But I am going to expose them for what they are because the "mentally ill" are already helpless, misunderstood, and traumatized enough. I'm not going to let another patient be driven to suicide after their "hopeful, healing therapy." It's happened for far too long and the "mentally ill" are conditioned that no one will take them seriously if they start talking about what goes on at treatment centers, so we don't speak out.

And more people suffer. And more people die.

I can't "do nothing" any longer.

This is a copy of an e-mail I sent to my mother while I was living there, detailing just a few instances of what went on there.

(The things I've written in parentheses is hearsay and thus has no valid authority for me to be bringing up, but taken into context with the things I have witnessed, I feel it is important to include these "rumors" and "hearsay" for the sake helping to possibly establish a long-running "culture of irresponsibility" at Skyland Trail)

The two most important issues I have concerns about concerning Skyland Trail is the high staff turnover rate and the policies about clients at the Skyland South residence. The first time I had an appointment with my counselor, Lori, I searched for her office but only found rooms identified "Counselor 1, Counselor 2, Counselor 3 and Counselor 4." I had to guess which one she was in because there was no documentation or nameplate as to whom each office belonged. When I finally found Lori, I suggested that the counselors put some kind of identification outside their doors, and Lori replied that they switched offices so much and people came and went so often that it was too much hassle.

In the short time that I have been at Skyland Trail, I have heard a lot about people's counselors leaving. I witnessed the breakdown of one individual who had grown very close to her counselor and asked the other patients if that kind of thing happened often. They responded that counselors frequently come and go. My anxiety increased a little because I was wondering if my counselor would also be frequently changing, as this is the main person in charge of my treatment, and in order for me to progress at Skyland Trail, I have to have a trust and background with the person treating me. I don't understand how I can develop that if the person I am working with will be changing once or more a month.

Yesterday during my check-in group, the woman who was leading asked if we had heard the news about Lori. None of us had heard any news, and asked her what she was talking about. She responded that it wasn't her place to say and that Lori would obviously tell us that day (Friday, September 8) if she hadn't already.

Later that day, I had my first individual meeting with Lori. I was honest to her about what I wished to accomplish and she appeared earnest in wanting to help me. She said that we'd work together on my issues and I left the meeting feeling hopeful that I would be able to become an independent, fully-functioning adult through the resources at Skyland Trail.

At the very end of the day, another woman who has Lori as her counselor confided that she'd just had a meeting with Lori, and Lori had told her that she was going to wait until Tuesday as to not ruin the woman's weekend and had actually been trying to avoid encountering the patient during the day, but since the patient had tracked her down (to ask her a question), she told her she felt obligated to talk. Lori told the woman that both she and her intern (the woman who substitutes for Lori) would be leaving. Lori also told her that I was the only person who did not know the news yet, leaving me to wonder exactly how long she would have strung me along, working with me on my issues before she finally told me. Lori still does not know that I know that she is leaving.

Seeing as how the counselors are probably the most important staple in a client's treatment, it concerns me greatly to know that they come and go so often. Being a counselor at Skyland Trail appears to be more of a temporary position than a job people apply for seeking a career. I've become suspicious as to how things are being run behind-the-scenes that causes people to leave so quickly. I do not know what to expect with regards to my treatment, as it seems to be handled by someone who doesn't have the capability to inform her patients of something as important as her leaving, and also how often this change of counselors will happen to me, as it seems to have happened several times with other patients.

The second most pressing concern I have with Skyland Trail concerns the safety of the environment at Skyland South. I've come to understand that several of the male patients at Skyland South come here directly from jail, and are here not because they wish to get treatment, but as a condition of their parole. I've learned at least one of the male patients here was in jail for assault and battery. The staff are just now beginning to plan room assignments divided by floor, with most of the males upstairs and females downstairs. However, there are still some females upstairs.

(I have heard disturbing accounts of some male patients stalking females and exposing themselves, and even though this was repeatedly brought up at community meeting and the patients told that they were "handling it," nothing actually happened until the father of one of the patients threatened to go to the news stations with the story. A common selling point of Skyland Trail is how only "3 out of every 10 applicants are accepted into the program," making it seem like there are rigorous standards and only very stable individuals are accepted. However, I have heard things about some clients who are still here - such as an individual who refuses to wear underwear, even on her period, or wash her clothes - the latter of which I've observed, as there are many stains on her outfits - that make me more inclined to believe that the only reason 7 people out of 10 who apply are denied is because they can't sign the check.)

Adding to the instability of the environment is the level of responsibility of the staff. Yesterday, I listened to a patient tell me that staff slept during the night in the media room and family room area, and this morning I walked into the media room upstairs to see Law & Order DVDs and blankets on the sofas. After a few minutes, a member of the staff came into the room, collected the blankets and turned off the tv. This is very scary to me, because if this member of staff is laying there, sleeping or watching tv upstairs, how are they going to notice if a male client comes out of their room at night and goes downstairs? The fact that when I woke up, there were only two females working makes me wonder how they would handle it if a patient assaulted another patient. Would these two women, sleepy and distracted, react in time to be able to pull a male off of a patient? Would they even have the strength to do so?

I've discussed this concern with another patient, only to be informed that when physical altercations do occur, the staff does nothing to intervene. The patients are told that the staff is not allowed to physically break up a conflict between patients. If someone broke into my room at night and started assaulting me, and I screamed, would the staff (after waking up and coming downstairs) simply call the police and stand outside my door because they "are not allowed to put themselves at risk?"

The third thing that concerns me about my stay at Skyland Trail is the air of unprofessionalism the staff has about them. Besides the sleeping at watching TV during the night, I've observed the staff using patient money - the "petty cash" that they are given every week that actually comes out of the patients' payments to Skyland - to purchase things for themselves. Yesterday evening, we went to Bruster's for ice cream, and not only did the patients get ice cream, but the staff member who took us used our money to buy ice cream to bring back for all of the staff.

At Menninger, only a qualified R.N. was allowed to dispense medication to the patients. At Skyland South, there are no R.Ns on staff and unqualified individuals dispense medication. They prepare the daily medications in advance for the week for each patient into a plastic container with separate tabs for each day of the week, and the patient is responsible for getting up and getting their meds on time. When you walk up to the office area, they open the tab for your day and empty the section into your hand. If you have a prescription for something that does not fit into the little divided section - for example, a liquid, or a nasal spray - you have to ask for it. This means that even though I have a prescription for Flonase to be taken every morning, they do not give it to me. I have to ask for it.

(I have heard about patients getting their medications messed up and the staff not being able to do anything about it because they don't know what each person is supposed to be taking.)

There are several personal reasons why I do not feel safe living at Skyland Trail. Allegedly, in order to be a resident, you have to be mentally stable, yet I am still very unnerved living with a male born-again Christian (also directly from jail) who talks a lot about Christianity and watches The Passion of the Christ several times a day upstairs in Media Room (which I have to listen to if I'm on the computer). Thursday, September 7th on the way back from LEAP at the HEC, we stopped at QuikTrip. There is one patient here who has a reputation of being very adamant about riding in the front seat, to the point where she's only allowed to ride it on Mondays. However, this evening the regular van driver who enforces this rule was not driving, and this patient was in the front seat this past Thursday. Apparently this patient has to be able to control the radio if she is in the front seat, and when another patient reached to turn the volume down a little, this woman got so upset that she jumped out of the van while it was still moving and ran off. In the handbook, there are certain guidelines that you have to follow or you risk being kicked out of Skyland Trail, such as passing room checks or attending groups. However, there is one patient who sleeps throughout most of his groups in the library at the HEC - causing it to be locked and unavailable for patients to use even in the hours when it's supposed to be open - and one patient who has been here several months and never passes a room check (the same female patient who doesn't wear underwear) and also smokes in her room at night, which filters through the vents and causes my room to reek of smoke. Neither patient seems to be on the verge of being kicked out for not following the rules, leaving me to believe that as long as you keep paying, they will keep you here.

There is a van that takes patients to and from the HEC every weekday. Only when the van is filled to absolute capacity, will they add a second trip. This means that only when there are 15 passengers who need to be transported will they do two runs. This would be okay if there were 15 functioning seat belts, but there are only about four seat belts that work in the entire van, two of them being the two front seats. In the very back row where four individuals are expected to sit, there aren't even four seat belt clasps (most of the lap seat belts appear to have been cut or torn off, leaving the occasional buckle/clasp in the seats).

(in regard to my mothers' assertion that large passenger vans aren't recommended or required to have occupants wear seat belts, I direct to this site: Department of Transportation - where it states:

"Insist that all occupants wear seat belts at all times. Eighty percent of those who died in 15-passenger van rollovers nationwide in the year 2000 were not buckled up. Wearing seat belts dramatically increases the chances of survival during a rollover crash. In fatal, single-vehicle rollovers involving 15-passenger vans over the past decade, 92 percent of belted occupants survived compared to 23 percent for unbelted occupants."

Further documentation about the danger Skyland Trail is putting its clients in with the use of these vans: Roll Over Lawyer)

The last thing that affects me from a personal and not professional standpoint, is the environment in regards to my eating disorder. In the handbook, it states that clients are provided three nutritious meals a day and snack times are posted. Snack times are not posted, and staff keeps the door to the pantry area locked at all times, so if we need to refill the fridge with water or need to get a vegetarian option from the fridge, we can't. There is one small fridge available to store things like yogurt and water. Staff is responsible for refilling the cereal - the only thing of substance that is available to clients 24/7, seeing as how they keep the door to the pantry locked - which only occasionally gets done. One staff member complained that she was the only person who ever refilled the cereal bins. The only yogurt flavor available is strawberry-banana, which not only do I dislike in taste but it has chunks of strawberries in it, making it difficult to take mix my medicine and swallow it with. In fact, a couple days ago we appeared to completely run out of yogurt and I was about to take my medicine in oatmeal when a staff found one strawberry-banana yogurt in the staffs' personal fridge. Staff does not appear to do regular inventory of the food stocking, and it is up to clients to inform staff when we are out of certain items - and then, we have to wait until the "grocery day," when we are driven to Krogers and staff uses the petty cash - again, taken from clients' accounts - to purchase foodstuffs. Keep in mind, staff also eats these items, particularly at breakfast.

The food that is available is restricted. During the weekdays, we eat lunch at the HEC and they are always running out of food, to the point where it is now rationed and occasionally the server will give you your portion and you can only get seconds after everyone else has gone through the line. However, staff members are allowed to walk in and get their portions first before the buffet area is even open to clients, and when it is open to clients, they cut in line. The group before lunch lets out at 11:45 a.m., and they will only open the doors to clients to eat at noon, though staff is allowed to go back and get their meals ahead of this time. As a result, by the time clients are allowed to get lunch, the food is lukewarm to cold and there is no microwave available. Back at the residence, there are only two vegetarian meals brought with dinner (and lunch, on the weekends), and if those are gone and the entree is pork or beef, I eat cereal for lunch or dinner. I could go into the pantry and get a veggie burger, but the pantry is kept locked and the evening staff will only allow you to go into the back during certain times.

On the weekends, apparently the food for Saturday and Sunday are both delivered on Friday, so we eat the hot food Friday and then have sandwiches every Saturday and Sunday. The food for the weekend meals are stored in the pantry, and as such the fruit that gets delivered isn't very fresh by the time we eat it. At the HEC, you are only allowed to take one small bowl of fruit - and it's mostly melon, with some pineapple, grapes, and watermelon. I talked to my dietician about this and she said that they would prepare a special bowl of fruit for me without melon, but I've only received it twice.

The quality of the food is bad, and the options that are available are all geared to encourage patient dieting, and I've been told as much - a major concern is that clients will gain weight, but I don't think that's the rationale as much as it is that they cut costs with food and food quality. Fruit Loops and Frosted Flakes used to be available, but they stopped being purchased with the rationale that the diabetics couldn't eat them, so they stopped - even though Special K and Raisin Bran was also available. Now Special K and Raisin Bran are the only cereal options available. Snacks like Lorna Doone and Oreo cookies also used to be available, but they were also stopped with the excuse that "clients wanted healthier options." These changes happened awhile ago, but the justifications for the changes are still on the door to the pantry and they tried to make it seem like it was really the clients who motivated the change, but the excuses they gave were less than believable. I really don't think that the diabetics were so bothered by the presence of cereal they couldn't eat, even though there were options they could eat available, that they complained. I also don't think the clients really complained about having cookies available for a snack - and even if they both were the case, even if there was a push for healthier alternatives, why did they need to take away the "junk food" as well? Why can't they purchase both healthier alternatives and indulgences? That's the obvious compromise, but instead all they stopped buying all the junk food and left patients with no choice but to eat the healthier alternatives. I am in a "dieting" environment.

Oh, and there's so much more. They had us have rigid "room inspections" twice a week, and every room (with a single bed) had its own bathroom. However, there was a woman who worked there named Vivian and EVERYONE hated when she was in charge of room inspections. Vicious Vivian. I (and others) had mold on our shower curtains. My shower stall wasn't as spic and span as Vivian wanted, so she told me to clean it better. I told her I only had one brush, and I used it for the toilet.

She told me that it didn't matter, I could use the same brush to clean the toilet... AND the shower.

We had a trash can while we were there, a huge nasty trash bin. The lid was absolutely disgusting to touch to open it. We were responsible for cleaning every single square foot of the South Residence, under the guise of establishing "personal responsibility." People were shelling out thousands for us to clean the facilities. There were two washers and dryers, but only one dryer (or maybe it was a dryer) worked for a residence of dozens of people. Any time you "acted up", you were sent to Ridgeview, but they were very curiously selective in how badly they allowed someone to get before they sent them there. A close friend of mine was sent there after they made up that she was suicidal and practically took an act of fucking Congress for her husband to find out where she was at. Some people ran away. Some people attempted suicide (including myself) while we were there. No one at the HEC cared, and no one at the residence gave a flying fuck about the patients.

Like I said... I think Guantanamo Bay provides a better healing environment than Skyland Trail.

I'm sorry, just another thing about the van (which I've learned they've since bought a bus, but the fact that they went for years doing this to patients makes me think that they will only do the very minimum to ensure that they are not sued or exposed): when the (VERY lazy) staff didn't feel like making multiple trips to a location, we'd actually sit on the floor of the van.

Thousands of dollars for that. They were actually paid to do what they did.

They need to be exposed and they need to be taken down.

This post has been sent to the following for comment:

Ray Kotwicki, MD, MPH
Medical Director

Chris Cline, LCSW
Admissions Director

Delphia Williams
Human Resources Director

Julie Dudkowski, MS, LPC
Community Relations Coordinator

Tara McDaniel, MS, LPC
Community Educations Series and Advocacy

Paulette Graham, LCSW
Director of Residential Services

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

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