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Saturday, October 11, 2008

The Royal College of Psychiatrists President - 2005

I believe that you all must know this editorial. However I've decided to copy and paste because it's beyond comprehension why so little is done.


Psychiatric Bulletin (2005) 29: 81-83
© 2005 The Royal College of Psychiatrists
Editorial
Dancing with the Devil? A personal view of psychiatry’s relationships with the pharmaceutical industry

Mike Shooter, President

Royal College of Psychiatrists

I had just spoken to a meeting of one of our users’ and carers’ organisations. Mingling at coffee time, I lapped up congratulations on how approachable the College had become, when I was brought up short by a long-term patient with a scowl on his face. ‘The trouble with you psychiatrists’, he said, ‘is that you’re all pill-pushers. You’re all in the pocket of the drug companies’.

As a child psychiatrist by trade, and as a President who has fought hard to tighten the College guidelines on sponsorship, I bridled at such stereotypes. But unfair though they may seem, the charges are persistent and deserve to be tackled head-on.

Reliance on medication

First, are we really ‘pill-pushers’ - do we rely on medication at the expense of other therapies? Well, let’s get one thing said straightaway: drugs do help. Few will now remember how the old phenothiazines allowed staff and patients in the late 1950s to tear down the walls that separated mental illness from the rest of the world, walls that reinforced the stigma of ‘them’ and ‘us’. The public who were appalled at what happened to Frank Bruno should appreciate that it was modern pharmacology that - by his own account - seemed to have returned him so effectively from intensive care to community. Frank’s experience is repeated in ward and clinic every day, through one drug or another. Whatever their ultimate aim, the pharmaceutical companies have poured billions of pounds into alleviating patient distress.

It would be comforting to think that attitudes to medication have shifted since the 1950s, from patient ‘compliance’ to ‘concordance’ - an agreement reached between patient and doctor, as equals within the therapeutic relationship, based on informed choice between all types of treatments. The reality, of course, is very different (Shooter, 2003). Patient power is only as good as information given, and that information is often poor. Not many patients will want complicated biochemical explanations, but where theories of drug action have changed so frequently, treatment is bound to seem empirical. Patients are entitled to ask their doctor why he or she is so keen on something whose mechanism is so little understood and whose side-effects can be so disabling, despite every effort to uncouple the therapeutic dosage from that at which side-effects occur (Tandon & Jibson, 2003).

Trust in the profession is further eroded when the suspicion grows that potentially catastrophic side-effects are being covered up. You would think that we would have learnt from the benzodiazepine story, when 16 million prescriptions were still being written every year, two decades after the first warnings had been sounded: but it seems we have not. The story is being retold with the selective serotonin reuptake inhibitors (SSRIs), through press headlines and the courts, and the price of medical protectionism will be just as high (Healy & Whitaker, 2003). If patients feel that they have been misled or kept in ignorance ‘for their own benefit’, how will they ever trust their doctor again?

All this is compounded when patients feel that medication is being ‘over-sold’, both in absolute terms and in comparison to other forms of help. Perhaps we should listen more closely to the narrative evidence of what patients feel like on their medication, rather than the randomised controlled trial that tells us what patients ought to feel because the science says so (Rose 2003). And when we do let in this element of subjectivity, it is the talking therapies that patients seem to value most, in combination with medication or in their own right. The problem is that medication is readily available (even in times of ‘postcode’ prescription) but the psychotherapies are not. Cognitive-behavioural therapy, of proven efficacy in an ever-widening range of illnesses, is difficult to implement in busy clinical settings. It is patchily available and therapists are poorly trained (Department of Health, 2001). Psychotherapy services are often seen as ‘soft targets’ by cash-strapped trust executives struggling to make ends meet. There is still too little emphasis on vocational rehabilitation - jobs and housing - so vital to the well-being of patients with severe illness (Boardman, 2003). And if all this is true of the patient population in general, it is even more so in the Black and minority ethnic communities where young African-Caribbean men are more likely to receive high doses of medication and have little access to any other therapy (Norfolk, Suffolk and Cambridgeshire Strategic Health Authority, 2003).

The demand for quick results

We should not imagine that this is a one-way equation, however. General practitioners, under pressure of time and numbers, will say that the public’s demand for a diagnosis and quick-fit medical cure is just as great in mental disorder as it is in physical illness. Psychiatrists under equal pressure, and uncertain of their role in multidisciplinary teams, are apt to retreat into what they see as unique to them - the prescription of medication; but they are right to worry about being dragged into the medicalisation of ordinary social unhappiness. Political imperatives to meet targets based on throughput, easily identifiable outcome measures and the reduction of risk are bound to favour short-term compliance with medication over more subtle, long-term shifts in psychological outlook (Adelman et al, 2003), and Black and minority ethnic communities again will feel that this discriminates against them most (National Institute for Mental Health in England, 2003).

So the charge of pill-pushing, I would suggest, is not a fair one. Most psychiatrists, like their patients, would prefer to engage in face-to-face, in-depth relationships, in holistic packages of help as laid down in national guidelines (National Institute for Clinical Excellence, 2002), emphasising recovery and mental health rather than illness (Vaillant, 2003). If they are prevented from doing so, it is as much the fault of factors beyond their control as any medically dominated attitudes of their own. But what of the second charge - that psychiatry has fallen into the hands of the drug companies. Is that quite so easy to refute?

Influence of the drug industry

Of the 731 physicians directly employed by the pharmaceutical industry in the UK, 25 are psychiatrists; they tend to be regarded with a mixture of curiosity and suspicion (Aitken et al, 2003). But there are other ways in which the services of psychiatrists can be ‘used’. Personal enticements - the mugs, pens and desk-top toys - are usually accepted unwittingly or without a second thought as the psychiatrist tours the trade stands; yet it all helps to advertise the company’s products. Walking into some consultants’ rooms is like entering a shrine to one firm or another, and one has to ask what message that conveys to patients about the objectivity of the advice they are about to be offered. Other enticements - free holidays, free trips to conferences and first-class travel - are more blatant both in hand-out and receipt. I cannot be the only person to be sickened by the sight of parties of psychiatrists standing at the airport desk with so many perks about them that they might as well have the name of the company tattooed across their foreheads. It simply will not do.

And what of research? We have long known about the methodological flaws that bedevil even the randomised controlled trial, or the overemphasis of results that when carefully analysed boil down to little more than the odd insignificant point on a rating score above psychotherapy or placebo. More worrying is the deliberate bias that enters the selection of research design to achieve particular aims, or into the publication of their results. Findings in studies of both antidepressants (Baker et al, 2003) and antipsychotics (Moncrieff, 2003) have been shown to be clearly linked to the level of drug company sponsorship. The psychiatrist reading through them in search of advice may already be floundering in zones of clinical uncertainty (Anderson, 2003). This may turn to despair when 90% of JAMA authors are shown to have drug company links (Healy & Thase, 2003) and even Cochrane Reviews have evidence of ghost authorship among them (Mowatt et al, 2002).

Suggestions have been made to limit such conflict of interest or at least to expose it. Authors might be asked to describe their exact contribution to the research and its write-up; all raw data might be made accessible from industry-sponsored trials; any direct interference from the sponsor might be outlawed and the role of ‘assistants’ carefully delineated (Healy & Cattell, 2003). But the level of mistrust in press and public is now so deep that the jobbing clinician will have difficulty in persuading the patient that the advice being given about medication is open and honest.

Is there the same mistrust of the College too? There are clear and tightened guidelines on the relationship of individual psychiatrists with the pharmaceutical industry, on the sponsorship of local educational events and on College activities as a whole. They are posted on the College website and open to criticisms of whether they are yet tight enough. The level of industrial sponsorship of College activities has been steadily and deliberately reduced; it now forms less than 5% of the College’s total income. Where a company sponsors a public education leaflet they do so with no strings attached and with the most discreet acknowledgement. Trade stands at the College Annual Meeting are not nearly as prominent as at some conferences overseas, and symposia sponsored by drug companies are kept separate from the main programme and clearly advertised as such. What little general sponsorship is still obtained for the Annual Meeting is used for entirely worthy causes - the lowering of attendance fees for trainees and support for psychiatrists from third-world countries, or users and carers, who would otherwise not be able to attend at all. In the interests of transparency, registers are kept of commercial links and public declarations demanded of any presenter about possible conflicts of interest.

In other words, the answer to the second charge, I think, is that psychiatry as a whole is not for sale, but certain psychiatrists regrettably are. The College has taken great pains to put its own house in order on this as on many other controversial subjects. To remain vigilant, we need to listen carefully to our own members, to the user and carer organisations and to patients like the one who accosted me at the meeting I started with. Yes, I did manage to persuade him that his charges were in part unfounded; but he persuaded me that a lot more needs to be done.

References

ADELMAN, S., WARD, A. & DAVISON, S. (2003) Setting up clinical audit in a psychodynamic psychotherapy service: a pilot study. Psychiatric Bulletin, 27, 371 -374.[Abstract/Free Full Text]

AITKEN, P., PERAHIA, D. & WRIGHT, P. (2003) Psychiatrists entering the pharmaceutical industry in the UK. Psychiatric Bulletin, 27, 248 -250.[Free Full Text]

ANDERSON, I. M. (2003) Drug treatment of depression: reflections on the evidence. Advances in Psychiatric Treatment, 9, 11 -20.[Abstract/Free Full Text]

BOARDMAN, J. (2003) Work, employment and psychiatric disability. Advances in Psychiatric Treatment, 9, 327-334.[Abstract/Free Full Text]

BAKER, C., JOHNSRUD, M.T., CRISMON, M. L., et al (2003) Quantitative analysis of sponsorship bias in economic studies of antidepressants. British Journal of Psychiatry, 183, 498 -506.[Abstract/Free Full Text]

DEPARTMENT OF HEALTH (2001) Treatment Choice in Psychological Therapies and Counselling. Evidence-based Clinical Practice Guidelines. London: Stationery Office.

HEALY, D. & CATTELL, D. (2003) Interface between authorship, industry and science in the domain of therapeutics. British Journal of Psychiatry, 183, 22-27.[Abstract/Free Full Text]

HEALY, D. & THASE, M. E. (2003) Is academic psychiatry for sale? British Journal of Psychiatry, 182, 388 -391.[Free Full Text]

HEALY, D. & WHITAKER, C. (2003) Antidepressants and suicide: risk-benefit conundrums. Journal of Psychiatry and Neuroscience, 28, 331 -337.[Medline]

MONCRIEFF, J. (2003) Clozapine v. conventional antipsychotic drugs for treatment resistant schizophrenia, a re-examination. British Journal of Psychiatry, 183, 161 -166.[Abstract/Free Full Text]

MOWATT, G., SHIRRAN, L., GRIMSHAW, J. M., et al (2002) Prevalence of honorary and ghost authorship in Cochrane reviews. JAMA, 287, 2769 -2771.[Abstract/Free Full Text]

NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE (2002) Schizophrenia. Core Interventions in the Treatment and Management of Schizophrenia in Primary Care and Secondary Care. London: NICE.

NATIONAL INSTITUTE FOR MENTAL HEALTH IN ENGLAND (2003) Inside Outside. Improving Mental Health Services for Black and Minority Ethnic Communities in England. London: Department of Health.

NORFOLK, SUFFOLK AND CAMBRIDGESHIRE STRATEGIC HEALTH AUTHORITY (2003) Independent Inquiry into the Death of David Bennett. Fulbourn, Cambridge.

ROSE, D. (2003) Collaborative research between users and professionals: peaks and pitfalls. Psychiatric Bulletin, 27, 404 -406.[Free Full Text]

SHOOTER, M. S. (2003) The patient’s perspective on medicines in mental illness. BMJ, 327, 824 -826.[Free Full Text]

TANDON, R. & JIBSON, M. (2003) Efficacy of newer generation antipsychotics in the treatment of schizophrenia. Psychoneuroendocrinology, 28, 9-26.

VAILLANT, G. E. (2003) Mental health. American Journal of Psychiatry, 160, 8.


Friday, October 10, 2008

English - the language of science

From time to time a Brazilian patient's book appear on the library shelves telling their lives and recovery from depression and bipolarity.
I've translated this excerpt from the book of the journalist Maria Rezende "The Journal of a bipolar" to show the importance of any information from US:

"Olavo, who is my psychiatrist, prescribed me Lamitor because he knew that it would be the best for me. Althought it was for sale it was still being on trial by psychiatrist but he had access to informations because he worked in California University. This is the med I take till today."

As people are not fully informed about what is going on in US whenever someone points out an American research, FDA drug approval or informations of any kind it's taken as the most reliable scientific truth.
English is the language of science and legitimates any kind of theory or hypothesis. Physicians who are from any American university or linked to any institution are much more competent than those who aren't.

Thursday, October 09, 2008

For Fiddaman














This AC/DC fan will have a special license and can park whenever he wants.
I've just phoned some Zepp's and they granted. I'll send you the identification Fiddy.
Welcome!

Wednesday, October 08, 2008

TGN1214 clinical trial - asking the media to do a good job

I've just found two e-mails I wrote to BBC in march 2006. It's about the TGenero drug trial that made 6 volunteers very sick. As i wrote in this post , by the time Philip Dawdy wrote an e-mail for two reporters of the Wall Street Journal and Stephany wrote a letter to Thomas Laughren, that I use to send e-mails even knowing that I will not have any answer.

This is one of them:

March 19, 2006
Dear Sirs,
About the Parelex, TGenero drug trial:
It was a bless in disguise that this horror happened in UK. Now you have hurt in your country young English citizens, a New Zealander and that is the reason why it is being reported. How many times horrors like this must have happened and has not been revealed.
This is the only way to catch attention to this horror and all the harm that Pharmaceutical Industry is causing in UK and around the world.
I do not use to watch CNN. But as the drug trial scandal is not being well reported by BBC, as I wrote before, I begun to follow the news on CNN. And I found out the reason why you cannot give too much information on this. I could not imagine that in UK the Pharmaceutical Industry use to advertise in search for volunteers in newspapers. Young people, students and unemployed are the target group to participate on these tests. Please, keep on doing your trials on english volunteers. Do not only look for poor people around the world.
It is in the Parliament review:
"A strong pound sterling makes matters worse for overseas companies. For those reasons, companies are increasingly placing their Phase II and III trials outside the UK, in low cost areas such as Eastern Europe, Russia and India." p. 18
The phase I must be in Africa and, as ethics is the last thing Pharmaceutical Industry holds dear, without people consent.
Perhaps the reason is:
"There is a shortage of appropriately trained clinical investigators in the UK, and this reflects lack of investment in clinical research and problems with clinical training pathways." p. 17
The review is very good and accurate. Unfortunately nobody pays attention.
I was astonished that CNN made a good approach on the matter interviewing doctors and even questioning ethics of Laboratories. BBC kept on repeating how luck that man was because he received placebo. From now on I will pay more attention on other sources. I was naive to believe that BBC is highly committed with good journalism. But I like Tim Sebastian even though "The Doha Debates" does not require all the skills he has. He was much better in HARDtalk.
Sincerely yours,

I've received a reply but unfortunately I have not save it but this is my answer:

Dear Mr. Giannini,

What I was trying to stress is that BBC did not put the TeGenero drug trial in a bigger approach.
In HARDtalk, Steven Sackur once said to a GlaxoSmith representative that this Laboratory is being regarded as very greedy.
I do not believe that BBC is not aware that Pharmaceutical Industry cares a lot about money. If you did not realize it refer yourself to the Business News. You will perhaps see a laboratory representative trying to explain to their shareholders that the antibiotics they sell is being tested to be used in many diseases as possible.
You have already made on Panorama a first step about the SSRIs problems and even Charles Medawar, from Social Audit, who is very concerned about this problem, was allowed to say three sentences. He also helped a lot with the Parliament review on "The Influence of Pharmaceutical Industry" and his name is on page 12.
As BBC kept on repeating that the laboratories need volunteers I begun to follow the news on CNN. And I found out one of the reasons why you cannot give too much information. I could not imagine that in UK the Pharmaceutical Industry use to advertise in search for volunteers in newspapers. Poor people, students and unemployed are the target group to participate on these tests. I was astonished that CNN made a good approach on the matter interviewing doctors and even questioning ethics of Laboratories. BBC, need more volunteers as Lady Janet Darbyshire kept on repeating. And "Almost half of all trial delays result from difficulties in finding volunteers, and that can equate with a company losing millions of pounds in sales for a new drug. " The Guardian.
The Parelex drug trial was reported because it has caused cytokine storm. The girl who claimed that her boyfriend was like "the elephant man" did not appear two days on BBC. You also forgot to say that the two of the must serious injured are in coma, perhaps for months. You forgot to report some others aspects of this scandal.
If you read http://www.guardian.co.uk/medicine/story/0,,1734446,00.html you will find more about this horror and also the story of a man who got sick in a "male pill" drug trial.
How many people got permanent damages in such trials but cannot complain for they suffer of a iatrogenic disease that has no name and they were paid to get sick?
I understand that you will not fight the Pharmaceutical Industry. But it was clear this time that you are protecting a lot.
Not only you. The MHRA, FDA, AMA.... Bush father....politicians. After all "It is the third most profitable economic activity after tourism and finance in UK."
And you can also rely on MHRA:
"The MHRA is looking at whether the reaction was caused by a manufacturing problem, contamination, a dosing error or whether it was some "completely unanticipated side-effect of the drug in humans".
Of course this has nothing to do with the drug. It was a contamination or manufacturing problem.
That is exactly what we cannot take any longer. The manipulation and the shameful way of depicting something tragic as a normal mistake are unacceptable.
We need to hear at least: "Certainly, action will be needed to stop any repetition of the tragedy that unfolded at Northwick Park. The sight of loved ones, horribly disfigured, will be indelibly fixed in the minds of friends and relatives who gathered by victims' bedsides" The Guardian
What I have learned from it all is not to rely on BBC's impartiality. I do not like CNN, but I will have the two views from now on. Unfortunately TV5-Monde became an entertainment channel and I have stop seeing it. If it had not changed I'm sure that they would have done a debate on this issue for it is a tragedy that has to do with health and have many aspects to be discussed. But in their News they explained how the drug trials are made in France and it is more ethical.
And of course keep on reading read newspapers.
I enjoy "The Doha Debate". Tim Sebastian is a very gifted man. But I believe it does not require all the skills he has. He was much better in HARDtalk.
I would love to see him in a Hardtalk with Simon Gregor, spokesman for the MHRA, Dr Thomas Hanke, TeGenero's chief scientific officer and some key persons who profit with this mad medicine that makes people sick, risks are more usual than benefits and even death is caused by medicines.
It is about time at least to start debating this vital issues that has to do with health. Does it sounds too idealistic? Guess so.
Sincerely yours,

Tuesday, October 07, 2008

Duke University and Seroquel XR for Social Anxiety Disorder

Duke University is conducting many clinical trials on mental health, neuroscience and neurological disorders.

1)Quetiapine XR for Social Anxiety Disorder

The purpose of this study is to examine:
  • The short- and long-term effectiveness and tolerability of quetiapine XR for the treatment of social anxiety disorder (SAD)
  • The continuation effects of quetiapine XR in preventing SAD relapse
Eligibility
We are looking for subjects 18-65 years old.
Requirements
The study consists of eight weeks of open-label treatment with quetiapine XR (50-400 mg/day). Those who show a minimal improvement will go into a 12-week period with either quetiapine XR or placebo.
There are total of 10 visits to Duke.
Compensation
Subjects will be compensated up to $270 after the completion of the study.
For more information, contact Nabila Lateef at 919-684-9701.

2)Generalized Anxiety Disorder

The purpose of this trial is to find out if the study drug can be used to improve symptoms of generalized anxiety disorder. We are looking for subjects between 18 and 65 years old.
Requirements
  • You will be taking the study drug, PD0332334, at a dose of 350 mg, 450 mg, or 600 mg, or a placebo.
  • Subjects cannot take antidepressants or antianxiety medications other than study drug during their participation.
  • The study lasts up to 10 weeks once enrolled and requires nine visits to Duke.
Compensation
The study pays $45 per completed visit. This is paid after your last study visit
For more information, contact Nabila Lateef at 919-684-9701.

These are 8 of the 29 clinical trials that Duke University is doing:

New Drug for ADHD ; Project Activate II: 60 Years or Older and Feeling Down? ; Having Trouble Sleeping with Depression? ; Are You Sad or Blue and Do You Enjoy Things Less Than You Used To? this one will use paroxetine (Paxil/Seroxat/Aropax) and duloxetine (Cymbalta); Suffering From Bipolar Disorder? investigational drug ; Aripiprazole and Lamictal in Bipolar Depression ; Lexapro in Atypical Depression ; Are You Depressed? ;.....


and many others. After reading it I will try to volunteer for this last one of this list.
Can you understand why do they test the same drug over and over again?
Quetiapine (Seroquel) is already being used off-label for anxiety disorder and it would be a great help legitimize the use of these drugs. AstraZeneca will be very happy with the results.

Wow! Just found this:

Brain Donors Needed for Alzheimer's Disease Research

The Joseph and Kathleen Bryan Alzheimer's Disease Research Center at Duke needs brain donors who:
  • Are at least 65 years old
  • Have no memory problems
  • Are willing to have yearly memory and neurological assessments in their home
  • Live within one hour of Duke

Enrollment in the Autopsy and Brain Donation Program must be made well in advance of death.
For more information, contact Mari Szymanski, RN,C, at 1-866-444-2372 or 919-668-1908.

I would donate if a research would really help and in my case it would be the effects that psych drugs causes to the brain.
Why don't they start this kind of research since there are already suspicions that some of these drugs can change the brain size? There are evidences that SSRIs, based on patients' reports that these drugs have caused cognitive impairments, sexual problems that persists after quitting - a condition known as PSSD - violent behavior and other side effects and the withdrawal syndrome is still not recognized as a problem.
Many questions I have will not be answered in my lifetime.

Friday, October 03, 2008

Taking a break


I'm taking a break. I have to try to get distance so that I can have focus.
Unfortunately I'm one of those people who are very passionate and get very involved emotionally with some issues.
I've been crying for no apparent reason till I realized it was because I've been thinking about mental health issues for the last 6 months and got angry and sad, sad and angry, angry and sad...
I've also found out the I've reached the end of my therapy. After 20 years the problems that led me to psychoanalysis are... I don't know how to finish this sentence. I'm not healed. I don't believe that there's such a thing in psychotherapy, but I'm fine and don't need to talk about them any longer.
The strange thing is that I thought that finishing therapy was something like: "Party! I don't need it anymore!"
It's not like this. I still don't know what does it mean not needing therapy.
That's why I'll see my therapist, ex-therapist... this week. :)
I'm also thinking about helping depressed people but I still don't know how.
I'm not feeling blue or sad. I only have to take a break to learn how to keep balanced and not getting angry and sad reading Furious Seasons and my blog buddies.
Blog friends are also a joy for me.
I wish I had written it before and that it was not the first post of October but perhaps that's a good beginning.


Tuesday, September 30, 2008

On forgiveness

Forgive your enemies, but don't forget their names...

Monday, September 29, 2008

Tenderly - Billie Holiday

Just listen. Don't pay attention at the photo.

Sunday, September 28, 2008

Sunday!

And I've received flowers!
These are Susan's roses and she was kind enough to send me this beautiful photo from her garden. My camera is out of order. I wanted to take some photos from my garden. Six tiny plants on tiny vases in an apartment.
But I love them! Every morning I put the three vases which need sun on the window. One of the plants is blossoming with tiny pink and purple flowers.
Have a nice week!

Friday, September 26, 2008

To the amazing person I met today and is depressed

Today I went to get prescriptions to buy the drugs I have to take due to withdrawal problems. I've met a wonderful person who is fighting depression since 2005.
This person shared with me some sorrows and there comes again that feeling of impotence. I wish I could be a therapist but I don't think I can because it's very hard for me to keep distance from people's sufferings. I feel like crying. Can you imagine your therapist starting to cry with you?
I told this person about my blog and the wonderful people I met because of this blog.
So my dear new friend, if you come here when you feel a little relief I want you to know that I care a lot about you and I have an idea about your feelings.
We all feel alone when depressed. There are many people like you blogging and finding support meeting other blogger buddies.
You know my real name and my face. You can see here that my identity is not revealed.
Many people do the same. This is part of the stigma we share.
If you feel like doing a blog you can write about whatever you want and not write whenever you want.
You told me that you're hating Brazilian's sun.
You can write about it... or not.
I just want to tell you that I know the wonderful person you are and I know all the power you have. And once again: don't feel guilty about being depressed. The person you are is trying hard to conquer but unfortunately depression wins. Cry and do what you can because you will find your way. Not tomorrow, not next week but little by little.
You'll be in my prayers.
Love
Ana

Thursday, September 25, 2008

Evergreening - the FDA help on making old drug get new patent

"‘Evergreening’ is the term used to describe the process by which the innovator patents trivial modifications of already-existing drugs which, in turn, extends their monopolies beyond the 20-year period granted for the original patent. It is a common practice in the pharmaceutical industry."

This is from The Economic Times. On this article it's explained how Wyeth have received a new patent to their blockbuster antibiotic Zozin that will expire in 2023 just by adding a purifying agent to its molecule.
Three companies, one from India have taken legal action against Wyeth.

"According to USFDA rules, a company is allowed to withdraw a product from the market only for reasons related to safety and efficacy. In case the product is withdrawn from the market, it is subsequently removed from the approved drugs’ reference list, and therefore no pharmaceutical company can market a generic version of this same drug.


"Zosyn is a safe and efficient drug. This is just a move to extend the patent life of the drug and prevent the entry of generic players in the market," K Raghavendra Rao, managing director, Orchid Chemicals & Pharmaceuticals, told ET."

FDA response to the Citizen's Petition (CP) filed by Orchid Chemicals in response to accusations of 'evergreening' related to Wyeth's re-formulated Zosyn (piperacillin/tazobactam):

10/30/2006 2006P-0442 Orchid Healthcare/Determine that Wyeth Pharmaceuticals, Inc. discontinued its previously-approved formulation of the Reference Listed Drug Zosyn (piperacillin and tazobactam for injection), 40.5 gram pharmacy bulk via Interim Response 04/23/2007


It's amazing that FDA has so little concern in promoting health and a huge concern with pharmaceutical industries profit.

Tuesday, September 23, 2008

Gaughin and Cézanne










This is Gaughin homage to Cézanne.
On the wall behind the woman Gaughin painted Cézanne's "Still Life with a Compotier", 1882.
It's amazing that even the woman is painted in a posture and with a certain Cézanne's way of portraying women and he signed his painting on the "wall" on the right just below Cézanne's.













Haven't you just seen part of this painting?

Monday, September 22, 2008

The Bipolar Children

While Philip Dawdy is trying hard to raise awareness on pediatric bipolar diagnoses*, a disease that is not still recognized by DSM, and the blogosphere discuss the article "The Bipolar Puzzle" New York Times Sunday Magazine I've decided to search "bipolar children" in Portuguese and in English.
"Children Bipolar"=
Results 433,000 and the "Criança Bipolar"= Results 97,900

In the Portuguese search the first answer that appears is a translation of this book review on "The Bipolar Child" : Demitri Papolos, MD and Janice Papalos.
.
It sounds strange to me that this book is the first result because it's not translated into Portuguese. I've also found an article on one of the two Sunday's Brazilians mags Veja where you can read:

"Recently a Harvard University study in US demonstrated that one out of three adults is bipolar."

Isn't it too much? When it comes from Harvard I don't know what to expect.

*"As I noted last week, the paper does not discuss or in any way delineate depression in pediatric cases of alleged bipolar disorder. I find that very strange, particular when it comes to discussing bipolar disorder in teens (still technically pediatric cases). The paper, and one assumes the FDA's definition, is almost entirely focused on what the authors call mania or manic-like symptoms. Despite that focus and a lengthy discussion of relevant literature, the authors never arrive at a firm description of the clinical features of "mania" in pediatric cases. In other words, they never trot out in DSM fashion the symptoms of the alleged disorder nor define its precise duration. If that's science, then the FDA also believes in cold fusion."

Sunday, September 21, 2008

Arte y Pico Award - Brillant Weblog Award


Clinically Clueless has honored me with this award that was created this year by an art-lover. According to the explanation of it's creator on her blog Arte y Pico means:

"What is the meaning of the expression: And basically, ironically, it translates into a wonderful phrase in Mexico, “lo maximo.” LOL! It will never find its counterpart in English, but if it HAD to, it would be something like, Wow. The Best Art. Over the top."

Thank you Clueless! Arts unite people and I believe we all are united not only by art but by part of our lives.

According to the rules I have to pick 5 blogs and I also have to choose 7 for the Brillant Weblog Award that Stephany has given me,

I've picked 7 blogs. Some bloggers has already received one of the awards but not the other and I would like to share both awards with them:

Jane
Jazz
Jena
Mark Krusen
Naturalgal
PreciousRock
Stan

This is a way to show how much we care about each other.

Saturday, September 20, 2008

Van Gogh and Toulouse Lautrec
















Impressionists used to portrait their friends and it was usual to show something related to the artist's work.
This is Van Gogh portrait by Toulouse Lautrec.



This is a 1884 Van Gogh painting. Haven't you just seen this glass and the bottle somewhere else?

The Vioxx case - when the side effect is physically noticeable

The Withdrawal of Vioxx

"In September 2004, Merck announced a voluntary withdrawal of its blockbuster drug Vioxx (a cox2 inhibitor used to treat pain and inflammation) from the market due to concerns of an increased user risk of cardiovascular problems, including heart attack and stroke. As a result, over 6,000 lawsuits were filed in the US and elsewhere by people claiming that they or their family members had suffered heart attacks as a result of taking Vioxx. Subsequently, it was revealed that Merck had known about the risks associated with Vioxx as early as 2000.
Furthermore, the company was accused of manipulating a study in The New England Journal of Medicines, whereby researchers who were sponsored by Merck deliberately erased a table with information about cardiovascular effects before sending it for publication. During the lawsuits two medical professionals testified that they were pressured by Merck not to publish test results that showed increased rates of cardiovascular disease. In early 2005 a study calculated that Vioxx caused between 88.000 and 140.000 cases of heart disease in the US.
In the first US lawsuit, which Merck lost, the jury demanded US$ 229 million in punitive damages. The amount was based on an internal document of Merck that estimated that the company could make US$ 229 million in profits if the publication of warnings on the product could be delayed for four months. Merck did spend about US$ 160 million on marketing for Vioxx annually." p. 11

Source: "Branding the Cure A consumer perspective on Corporate Social Responsibility, Drug Promotion and the Pharmaceutical Industry in Europe"
Published by Consumers International in June 2006.
© Consumers International, June 2006.
This study is available on the site and shows how pharmaceutic industry works. The companies studied included: Abbott, AstraZeneca, Admirall Prodesfarma, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson) (J&J), Lilly (Eli), Lundbeck, Menarini, Merck Sharp Dohme, Novartis, Novo Nordisk, Nycomed, Orion Pharma,
Pfizer, Roche, Sanofi-Aventi, Schering AG, Schering-Plough and Wyeth.

To Susan







Van Gogh's Paris's roofs

















A photography taken decades after Vincent's painting. Ops... a century after.

Monday, September 15, 2008

"I still become out of control angry living in a world where only a select group of people on the internet even understand the harm done to me."

"A world prepared to let somalia fester for 20 years, and let africa starve, can hardly be expected to suddenly dawn an age of reason in mental health. I don't know."

"When harm lasts thousands of days and grows in intensity, its hard to land again."
by Poe

Whenever I read this comment that Poe left in Furious Seasons I cannot help myself from feeling touched.
I'm fine but I cannot live behind this issue. I don't even think about what has happened to me but... perhaps I'm lying to myself. Why do I get so touched and angry?
Yesterday when I've received the newspaper with the story of the drug-dealer that was arrested in a mental institution I was infuriated. I go to this institute and talk to some patients or family. There's always a story, a sad story.
I think a lot about some of my blog buddies and seeing people suffering without knowing that they are taking drugs that are causing them harm and I cannot do anything...
I don't know. I really don't know. I feel like crying, I get angry... I don't know.

Sunday, September 14, 2008

Sunday!!!!!!!

(imagine your beautiful landscape)







I have to breath and be at a quiet and beautiful place keeping my mind in peace. I hope you can do the same.

Drug-dealer was arrested as patient in UFRJ Psychiatric Institute

This is the the news on a Brazilian newspaper published yesterday. The photo is the drug-dealer using the Institute's uniform with it's name on the shirt "IPUB" while taking photos back in jail.
I would really like to know why on earth a drug-dealer was transfered from the penitentiary to a mental institution. For the last three weeks he was being treated as a patient on the Institute of Psychiatry of Rio de Janeiro's University - IPUB. What diagnoses did he receive? Drug addiction? I wonder why a patient have to carry a gun and receive visits to bring him drugs and high amounts of money.
There are people on this hospital being treated for drug addiction and I believe it's harder to quit when having access to drugs on the very place you're receiving psychotropics like Zyprexa to cope with withdrawal symptoms.
Unfortunately I'll have no answer because whatever happens in Brazilian mental institutions have no explanations whatsoever!
This is a very serious case that put in danger patients. People who belong to jail being treated as mental health patients is beyond comprehension and I would really like to receive some explanations from Dr. Marcio Versiani who is the director of IPUB, member of APA,
Collegium Internationale Neuro-Psychopharmacolicum (CINP) and of Psycho-pharmacology Commission of the WPA and others.
As I don't think that a director has time to give these explanations any person from the Institute could explain how can it be that a drug-dealer was being treated as a patient in IPUB and when the police went there to arrest him he tried to get his gun.


Brillant Weblog Award


Stephany, you all know her blog Soulful Sepulcher and for her constant work trying to raise awareness on mental health problems, has honored me with this award.
This is a very special award to me because I admire Stephany not only as the brilliant advocate she is but for many of her qualities and character: a woman, a friend, a mother, a writer, the way she finds poetry in simple things, the way she is.
I thank you very much Stephany and I'll take it as a huge encouragement to keep on trying to help you and others to bring to public attention the problems of mental health treatments.

Now it's time to face the hard job of thinking about seven bloggers among so many amazing people.

Thank you Stephany.