Abilify, an atypical antipsychotic developed for adult schizophrenia, has recently been approved for irritability and self harm in children (aged 6-17) diagnosed with autism — an antipsychotic! These companies are out of control with their attempts to extend the range of approvals for their atypicals and Abilify seems to be leading the pack, chronologically, at least. It was also the first to get approved as an add-on for depression.

Autism is a difficult thing to contend with — I know first hand — but to dose a kid up on schizophrenia drugs to control irritability is truly beyond comprehension. I’m sure there has been plenty of off-label use in just this capacity but one must wonder if the FDA even cares what they pass anymore. I’ve long given up wondering if there are any consciences at the tops of these companies.

Add this to the pile of proof positive that atypicals are the new restraints. Consider the many uses for which these drugs are being granted approval and used off-label, and then think back. How many of these same “symptoms” were formerly handled with physical restraints of the most barbaric kind?  They are actually being used even more generally and increasingly in younger kids with more mild behavioral problems. For those who think we should be grateful for less barbaric restraints, think again. We don’t need alternative abuses but true treatment. Putting the shackles or strait jackets or five-point restraints in a bottle is not the same as treating a disease or a disorder. It is no less barbaric or abusive under the guise of legitimate medicine. This isn’t a kinder, gentler approach anyway. Not when you see kids growing up with any number of very real ailments, like diabetes, cognitive dysfunction and tardive dyskenesia — and that’s just the ones that make it past the strokes. Oh and by the way, Bristol-Myers Squibb, makers of wonder drug Abilify, just closed on Monday with stocks at a record high for the year. Some people know a cash cow when they see it.

I know that many parents are truly desperate for answers, options and alternatives in addressing autism and related behavioral issues and we should be finding them but drug companies cannot continue to be allowed to determine the standard of care. Antipsychotic use in children both on and off label is out of control and has been for some time and irritability in children with or without autism is not psychosis. After all this time, we still have a very narrow understanding of the mind and the brain is perhaps an even greater mystery. So how can we be so bold as to take something so intricate and foreign to us and try to fix it with the biggest hammer we can find?  Some answers will not be found in a bottle, no matter how desperately they are sought and trading away health for desirable behavior –while great for investors and easiest for educators and often even parents — is always going to a bad choice for children.

Bioinformatics is a computer intensive field, so it is quite natural to find that experts in this discipline tend to post a lot of useful information on the web. In fact most professors teaching bioinformatics courses, book authors, and creators of important algorithms have extensive web sites filled with tutorials and educational information. The challenge is to locate the resources that you need for your personal education without spending months of your time surfing the web searching for these gems.

There is a clear need for an organized central resource that collects links to bioinformatics training material. The EXOME™- Horizon (EH) is an attempt to fill this need.

EXOME™ Horizon, an enabling service for Bioinformatics is a “Unified bioinformatics Learning Environment” that integrates the tools to learn, appreciate, explore and teach Bioinformatics in an optimal way. It facilitates the understanding of Bioinformatics among researchers and students.

The EXOME™ Horizon is an organized collection of Sequence Analysis tools, Structural Bioinformatics tools & Drug discovery tools, Comprehensive tutorials, In-built databases, On-line references, Sample test datasets, etc. In short everything that interested scientists/student’s need in order to train themselves in the emerging discipline of bioinformatics

EXOME™ Horizon is a service offering that consists of Sequence Analysis, structural bioinformatics and Drug Designing modules. EXOME™ Horizon uses workflow model through which a user can effectively and efficiently comprehend the procedural steps of sequence analysis, structure analysis and drug designing.

Listed below are just some of the areas in which training is conducted using EXOME™ Horizon:

* Genomics -Sequence/Structure Annotation, Phylogenetic Analysis, SNP Analysis, Genomics/Comparative
* Proteomics – Structural Bioinformatics, Protein Modeling and Simulations
* Cheminformatics -Pharmacophore/QSAR Modeling, Combinatorial Library design, Molecular Dockings, Structure Based Drug Designing, Toxicity Modeling and Prediction, Chemical Databases

Some of the salient features of EXOME™ Horizon other than the one mentioned above are as follows:

1. Client server architecture minimizes the cost per user.
2. Minimizes the hard ware requirement to a Server
3. User specific & secure work space
4. Comprehensive help menus for self learning
5. Limiting the use of internet bandwidth with inbuilt data bases- Nucleotide, PDB, PDBQ etc.
6. Interactive GUI removes the pain to learn and write commands to run an application.

Easy to understand the results/output through graphical representation and saves valuable time in understanding the application specific output

For any further queries on EXOME™ Horizon, kindly contact Rajesh

Medical News: ESSM: Flibanserin Boosts Sex Life of Low-Libido Women – in OB/Gyn, General OB/GYN from MedPage Today

The drug was originally developed as an antidepressant. Animal experiments had suggested it might have a more rapid effect than serotonin reuptake inhibitors, but it failed to substantially reduce depression symptoms in a clinical trial.

However, the potential to increase female sexual desire became apparent during the study. Reportedly, trial participants were reluctant to return unused pills when the study was over.

Medical News: Early Data Link Diet Drug to MI, Stroke, and Cardiac Death – in Product Alert, Prescriptions from MedPage Today

Preliminary analysis of data from a placebo-controlled study of sibutramine (Meridia) suggested an excess risk of cardiovascular events including myocardial infarction and cardiac death among patients taking the diet drug, according to the FDA.

Medical News: Ziprasidone Okayed for Bipolar Disorder – in Psychiatry, Bipolar Disorder from MedPage Today

Ziprasidone comes with a long list of precautions and contraindications:

 

* It should not be used in patients with a known history of QT prolongation, recent acute myocardial infarction, or uncompensated heart failure, and should not be used with other QT-prolonging drugs.
* It should also be avoided in elderly patients with dementia-related psychosis, as studies have shown that ziprasidone increases the risk of death in such patients.
* Discontinuation should be considered in patients showing signs of tardive dyskinesia.
* Treatment should be stopped immediately in patients with symptoms of neuroleptic malignant syndrome, which include hyperpyrexia, muscle rigidity, diaphoresis, tachycardia, irregular pulse or blood pressure, cardiac dysrhythmia, and altered mental status.
* Patients and clinicians should be alert for hyperglycemia, rash, seizures, and orthostatic hypotension with ziprasidone.

Medical News: Three Drug Classes Associated with Falls in the Elderly – in Primary Care, Geriatrics from MedPage Today

More than 30% of people ages 65 years and older experience a fall annually. Falls are associated with more than 40% of nursing home admissions, so research into risk factors “is urgently needed,” according the the researchers.

 

Who’s behind the madness? This wacky viral campaign that has been labeled “brilliant,” “borderline genius,” “idiotic,” “over-the-top,” a “viral pharma phenomena?”

S&R Communications Group in Durham, North Carolina, launched the Pharmageddon 2012 campaign in July of this year. Pharmageddon2012 stemmed from years of angst among our company’s pharma veterans and newbies alike. Watching an industry that had given us so much hurt itself to this extreme was a punch in the gut. Unprecedented times called for a change. A breakdown of physician trust, impending patent expirations, shrinking pipelines, poor marketing practices, overzealous sales goals, poor targeting, feeble attempts in new technological mediums, misinformation, disjointed messaging, confusion, collapse. These are a handful of the issues, a snowball effect over the last decade in the pharmaceutical industry.

Pharmageddon 2012 is a conversation. It is one of which many have been aware for some time, but few have had the stomach to acknowledge and adjust. As we presented, analyzed, and discussed the issue facing pharma, S&R Communications Group, after 18 years in the business, decided to become 2 specialized companies: S+R Medical Communications, which will concentrate on redefining branded medical education, and Friday Morning, an exciting advance in the philosophy of what promotional consultants can provide to pharma.

S+R Medical Communications

Curriculum That Communicates

S+R Medical Communications is a full-service, independent, medical
communications company relentlessly pursuing breakthrough creative strategies and programs for its clients. S+R Medical Communications will provide the educational vehicles that brands need to rebuild trust and help physicians and patients make better, more informed choices in healthcare. It provides educational programming that is needs-based, transparent, engaging, and disseminated through multiple channels, from traditional to digital media. For more information, please visit srmedcom.com.

Friday Morning

A New Approach to Yes

Friday Morning is a reaction to the breakdown in promotional effectiveness and commoditization of ideas pervading pharma. It offers solutions on a project basis, through a powerful combination of deep industry experience and unique insights into what physicians will and will not respond to as promotion. As promotional consultants to the pharmaceutical industry, Friday Morning collaborates with like-minded individuals who appreciate the necessity of communicating with physicians in a more profound way. With a philosophy and process fostering fundamental reexamination of its customers’ external and internal communication practices, Friday Morning is dedicated to the idea that patient outcomes, physician confidence, and client success are inextricably interconnected. For more information, please visit fridaymorning.com.

MedAdNews

Read more about Pharmageddon 2012, S+R Medical Communications, and Friday Morning in the November issue of MedAdNews

Wednesday pm 25/11. New Hunts house.

Not designed for PhDs but you will have an opportunity to listen to reps form AstraZeneca, BBSRC, Health Protction Agency, Science Museum – and much more

Another industry questions the usage of social media.

http://www.lifescienceleader.com/index.php?option=com_jambozine&layout=article&view=page&aid=3922

It looks like an opportunity to me, especially when momnitoring adverse events (sometimes referred to incorrectly as “side effects”)  in patients using the meds.  Even bad news might still be OK.  Adverse events are usually bad news for drug companies.  But if those are reported in real time in controlled environments such as private tweets, the company has a chance to react.  Historically, pharma companies are too big to turn on a dime.  They don’t stop Phase III trials unless there’s a tremendous reason to do so.  Response times to these events MUST decrease in the 21st century. Profitability depends on it.  Accountability depends on it.  The public will not accept pharma companies who fail to respond promptly to what amounts to ignoring adverse events.

But HIPAA has yet to surface on the subject…

-Tim Tucker

Another industry questions the usage of social media.

http://www.lifescienceleader.com/index.php?option=com_jambozine&layout=article&view=page&aid=3922

It looks like an opportunity to me, especially when momnitoring adverse events (sometimes referred to incorrectly as “side effects”)  in patients using the meds.  Even bad news might still be OK.  Adverse events are usually bad news for drug companies.  But if those are reported in real time in controlled environments such as private tweets, the company has a chance to react.  Historically, pharma companies are too big to turn on a dime.  They don’t stop Phase III trials unless there’s a tremendous reason to do so.  Response times to these events MUST decrease in the 21st century. Profitability depends on it.  Accountability depends on it.  The public will not accept pharma companies who fail to respond promptly to what amounts to ignoring adverse events.

But HIPAA has yet to surface on the subject…

-Tim Tucker

3SBio is a Chinese Biotech company.

I bought 110 SSRX shares on Aug 1 2008 for $9.15 each. I spent a total amount of $1001.5

Today I sold 77  SSRX shares @ $13.21. I made a total amount of $ 1017.17.

I am $11 richer and I do own 33  free  SSRX shares, which hopefully one day will make me rich, thanks to my free stocks strategy.

It’s Thanksgiving week! We’ll plan on publishing the Daily on Monday/Tuesday, then take the rest of the week off from news reporting. Unless somebody buys somebody else. That, we’ll report!

TODAY’S NEWS

Sanofi chief wants to do things differently. Liked this juicy quote:  Mr Viehbacher added: “The best scientists are often lousy leaders [and] managers. You had a research and development god who hoped a blockbuster emerged. When it didn’t, you merged. The model was flawed. I think the mistake we made in our industry was, we made R&D organisations that were very big, very complex, very difficult to manage, and we killed the innovative spirit”…more

Morphine – kill pain, grow tumors?? – Two new studies add to growing evidence that morphine and other opiate-based painkillers may promote the growth and spread of cancer cells…more

Pfizer reaps one of the consequences of merging: inherited lawsuits – Two Pfizer Inc. units’ hormone- replacement therapy drugs caused an Illinois woman’s breast cancer, making them liable for at least $6.3 million in damages, a Philadelphia jury ruled today…more

B-I hoping to take a big bite out of warfarin – Just 2.4 percent of patients given Pradaxa for six months after their initial treatment developed clots in the legs and lungs, similar to the 2.2 percent rate for those given the generic drug warfarin, according to an abstract of the so-called Recover study posted on the American Society of Hematology Web site last week. There was no increased risk of major bleeding, a complication of blood-thinning treatments…more

RECOMMENDED

Specialty/Oncology training and development. If you’re looking to enhance your training program for specialty reps, we have just the providers for you.  Contact us (stevew at impactiviti dot com, or phone at 973-947-7429) for recommendations.

PLUS

What about that pesky Social Media/ROI question? My thoughts…

JUST FOR FUN

———-

Subscribe to the Impactiviti blog via e-mail (which will bring you Impactiviti Daily – a brief of the day’s top pharma news)

Sign up for the Impactiviti Connection twice-monthly e-newsletter (see sample)

Connect with Steve Woodruff

ORBIS Bioscience Business Training Programme and Internships

Deadline: 15 January 2010

Please register early as places are limited.

Salary: Approx. £1000 per month training stipend
Location: Within bioscience and healthcare sector companies in London and the South East

- Are you a recent graduate seeking paid work experience in the bioscience sector to upgrade your skills and enhance your CV?
- Maybe you have just graduated and want to spend some time in a bioscience company to find out more about the type of work available in the sector?
- Or perhaps you are a graduate with work experience but have recently been made redundant and wish to continue in the bioscience sector?

Following the successful placement of over 35 interns  at graduate, masters and postdoctoral level the ORBIS Programme is recruiting now for a variety of exciting paid 26-week internship placements to commence in February 2010.

We are looking for bright, energetic, innovative and talented graduate-level individuals to take up placements within bioscience and healthcare related companies.  The companies involved with the programme are mainly based in London and south east of England and include emerging biotechnology companies, medical device manufacturers, intellectual property consultants, technology incubator facilities and multinational pharmaceutical giants.

During your 26-week internship placement you will be paid approximately £220 per week as a tax free training stipend.  You will gain valuable workplace experience in an exciting company environment and you will also receive 12-days of bio-business training in London. An ORBIS internship will provide you with a skills development opportunity that will help you to compete more effectively in the job market. The bio-business training will supplement your technical skills and know-how by helping you to understand how technology-dependent businesses can become more enterprising and effective.  During your internship you will have the opportunity to find out more about the different types of work available within the bioscience sector and your placement may lead to permanent employment.

Individuals with an undergraduate, masters or doctoral degree in medical science, bioscience, biology, bio-engineering, chemistry, manufacturing, business/management, marketing or IT related subject areas are welcome to apply for these internships.  All applicants must be recent graduates, or have limited workplace experience, or have been recently been made redundant.  You must be entitled to live, study and work in the UK, and if necessary, you should have a relevant working visa.  The details of eligible registered applicants will be shared with the companies hosting interns.  If your knowledge, skills and aptitudes match their requirements you will be invited by the company for an interview and if successful will be offered a 26-week ORBIS Internship.

Interested graduates can obtain more information on the ORBIS internship programme and instructions on how to register at www.rvc.ac.uk/enterprise/orbis

Sehr spannender und ausführlicher Artikel zum Thema – Lesebefehl:

Das für mich aufregendste sind aber die widersprüchlichen und höchst mysteriösen Untersuchungsergebnisse um die Rolle von Squalen im Zusammenhang mit dem Immunsystem, die sich derzeit nicht erklären lassen und eigentlich Horden von Wissenschaftlern anlocken müssten.

via Aggregat7 : Impfungen, Wirkverstärker und das Golfkriegssyndrom.

Drug Makers Raise Prices by 9% while inflation fell by 1.3% – http://bit.ly/352NLi
Legislators should simply index the Health Care Reform tax that Pharma will pay to 2008 dollars, then prorate as Pharma raises prices. If Pharma raises prices by 9%, their tax rises by 9%.

We need an inquiry; Drug Makers Raise Prices by 9% while inflation fell by 1.3% – http://bit.ly/352NLi

By equating medical ghostwriting to plagiarism by students, Senator Grassley hopes to dent the cozy relations between Medical School Profs and Big Pharma! – http://bit.ly/3KceDM

Über meinen Netzwerkpartner Volkstribunal erhielt ich einen Link zu einer Mitteilung, die ungeheuerlich klingt, aber vieles, was in der letzten Zeit geschieht, einen realen Hintergrund gibt. Ob es jetzt wieder mal ein Fake ist oder nicht, das kann ich noch nicht genau beurteilen. Ich weiß aber, dass meine Freunde (ich befinde mich z.Zt. in der Nähe von Prag) wehleidig auf Deutschland und Österreich schauen, weil dort so ein Aufstand durch die Medien geht, was sie hier nicht begreifen können. Nach dem Lesen dieses Artikels aber werden sicher viele zum Nachdenken angeregt werden.

Der Artikel beginnt so:

Warum sind die kritischen Berichte über Impftote im Ausland eigentlich plötzlich verstummt? Was geschieht zur Zeit in den Ländern mit Zwangsimpfung? Warum wird der Lissabon-Vertrag noch schnell zum 01.12.2009 in Kraft gesetzt, anstatt erst zum Jahreswechsel?

Gibt es plausible Erklärungen für all diese Ungereimheiten oder sind es nur “Verschwörungstheorien”? Was hat es mit dem auffälligen Schweigen der Medien zu diesen Fragen auf sich?

Bitte hier weiter lesen und nach Möglichkeit, wenn man es verantworten möchte, weiter verbreiten:

http://www.wahrheiten.org/blog/2009/11/08/das-schweigen-der-medien-unglaubliche-hintergruende-zur-schweinegrippe/

Bitte in meinem Blog eine Bestätigung abgeben, wenn es jemand übernommen hat. Danke.

Übrigens sind auch die weiteren Berichte des Verfassers lesenswert, die vor oder nach diesem Artikel stehen…

We are looking for candidates for an Account Manager Role for a Pharmaceutical Company in UK . This is a permanent role with one of our clients, a Leading NASDAQ listed IT Services company.

Write to kaushik [at] avanceservices [dot] com for more details

Role : Account Manager
Location : UK
Vertical : Pharmaceutical, Healthcare and Lifesciences
Compensation : Competitive

Referral Reward – 1000 Euros
There is a referral reward of 1000 Euros on a success fee basis for this role i.e. we will pay this reward if the person you refer is selected for this role, joins this position and meets some basic client obligations in the first 3 months

We will reply to you within 2 business days for any candidates that you recommend and whom we have already spoken to in the past for this role. This referral reward offer is valid only till December 5th -2009

Laut „Arzneiverordnungsreport 2005“ verordnen deutsche Ärzte heute doppelt so häufig Medikamente gegen Depressionen wie vor zehn Jahren und dreimal so häufig wie 1990. Ein besonders starker Trend zeigt sich bei der Verschreibung der selektiven Serotonin-Rückaufnahme-Inhibitoren (SSRI): Innerhalb eines Jahres stieg die Zahl der Rezepte mit dem Wirkstoff Citalopram um 18,8 Prozent, Sertralin-Präparate nahmen um 15,2 Prozent zu. Die Wirksamkeit der SSRI gilt zwar als gut belegt, die Liste ihrer möglichen Nebenwirkungen ist jedoch beängstigend lang. Anders als bei Johanniskraut-Extrakten, die – wie aktuelle Studien zeigen – auch in der Langzeitbehandlung den chemischen Antidepressiva ebenbürtig sind.

Prof. Dr. Markus Gastpar, Klinik für Psychiatrie und Psychotherapie in Essen, stellte kürzlich in München die Ergebnisse zweier Vergleichsstudien vor.
In einer Kurzzeitstudie über sechs Wochen haben 388 Patienten mit einer mittelschweren Depression einmal täglich entweder ein Scheinpräparat (Placebo) oder 20 mg des SSRI Citalopram bzw. 900 mg des Johanniskraut-Extrakts STW 3-VI eingenommen. Die Wirksamkeit der Therapie wurde mit Hilfe der international gebräuchlichen Hamilton-Depressions-Skala beurteilt. Das Ergebnis:

• Sowohl SSRI als auch STW 3-VI waren dem Placebo gegenüber signifikant überlegen. Das pflanzliche Arzneimittel verbesserte die depressive Verstimmung bei vergleichbar vielen Patienten, wie das synthetische Präparat.
• Eindeutig besser schnitt Johanniskraut in der Verträglichkeit ab: Unerwünschte Nebenwirkungen gaben lediglich 17,2 Prozent der damit behandelten Patienten an, vergleichbar mit der Placebogruppe. Von den Patienten dagegen, die Citalopram erhalten haben, berichtete jeder zweite (53,2 Prozent) über unerwünschte Arzneiwirkungen.

In einer zweiten Studie verglich Professor Gastpar den Johanniskrautextrakt STW 3 in Langzeittherapie von 24 Wochen mit dem SSRI Sertralin. Dabei wurden 241 Patienten mit mittelschwerer Depression entweder mit 600 mg STW 3 oder mit 50 mg Sertralin behandelt.

Von Anfang an zeigte sich STW 3 mit Sertralin therapeutisch gleichwertig, nach 24 Wochen hatten 84 Prozent der Johanniskraut-Patienten auf die Therapie angesprochen, in der Sertralin-Gruppe waren es 81 Prozent.
Bereits nach 8 Wochen haben sich die Beschwerden in beiden Behandlungsgruppen von 23 Punkten im HAMD-Score am Anfang auf 9 Punkte unter STW 3 bzw. 8 Punkte unter Sertralin verringert. Nach 20 Wochen lagen beiden Gruppen bei 7 Punkten.

Zum vollständigen Artikel =>

Quelle: phytotherapie-komitee.de

Greetings readers,

And how are we on this rather crisp, Autumnal afternoon? Well, I hope. So the perceptive amongst you will have already picked up the topic of discussion in this post – Nexavar, a drug prescribed for end-stage liver cancer. Indeed, what prompted me to write this post apart from having itchy fingers, is the BBC News article which reports on NICE’s recent recommendation that the drug is cost-ineffective. To this end, the drug has been rejected for use in the NHS in England, Wales and Northern Ireland, based upon its cost of about £3,000 per month (equating to roughly £36,000 per year).

In the context of liver cancer, the statistics show that only about 20% of patients are alive one year after diagnosis, dropping to just 5% after 5 years. Clearly the prognosis for sufferers is not great. However, the evidence has demonstrated that Nexavar can extend life by 3 to 6 months, with proven effectiveness. Indeed, anecdotes from carers of those with liver cancer point to the fact that the drug does indeed prolong life by precious months, if not longer.

Professor Jonathan Waxman, who is a clincal specialist in Oncology based at Imperial College, London, has spoken out over his misgivings on the recent NICE guidance, suggesting that some sort of public debate should be initiated surrounding such a sensitive and pertinent issue. This comment has been in addition to Mike Hobday, head of campaigns at Macmillan Cancer Support, who said he was “extremely disappointed” at NICE’s decision. However, Andrew Dillon, chief exec at NICE, defended the body’s decision that Nexavar is simply cost-ineffective, and that this money could be better spent elsewhere (obviously indicating the opportunity cost is simply too high in this instance). However, I am sure patients with liver cancer, and their families will feel somewhat differently about this.

Currently, NICE guidance over whether the NHS should fund treatments refers to a threshold of £20,000 -£30,000 per quality-adjusted life year (QALY), which Nexavar evidently exceeds. In light of this, a recent government review of end-of-life treatment  said “NICE should give extra weight to drugs that could extend a patient’s life”. However, I understand the predicament that the government is in; unfortunately, we do not have unlimited funds for drugs in this country, and based upon this, a body like NICE serves an invaluable role in guiding whether or not new drugs are cost-effective (based on an arbitrary threshold on the value we place on human life). The sad fact of the matter is that many patients suffering from end-stage liver cancer are also likely to be of advanced years, and though this shouldn’t be an explicit factor, extending the life of several hundred people a year by several months is not at the top of the Department of Health’s list of priorities.

I understand the rationale behind this, but it does make me hope that God forbid (and I am not a religious man), if I do end up with a chronic, intractable illness for which a specific treatment has been advised against by NICE, my specialist either ignores this evidence, or I have the funds to pay out-of-pocket.

On a final note, I would like to refer you to an interesting article I stumbled upon in the BMJ, with a head-to-head argument  over whether NICE’s threshold range for cost per QALY should be raised or  not.

And on this rather cheery note, I bid you a good weekend!

Thank you for reading,

Faisal.