Monday, March 19, 2012

News and Events - 20 Mar 2012




NHS Choices
16.03.2012 21:00:00

“Human resistance to antibiotics could bring ‘the end of modern medicine as we know it’,” according to The Daily Telegraph. The newspaper says that we are facing an antibiotic crisis that could make routine operations impossible and a scratched knee potentially fatal. Similarly, the Daily Mail’s headline stated that a sore throat could soon become fatal.

The alarming headlines follow a new report by the World Health Organization (WHO , which set out ways to fight the growing problem of antimicrobial resistance (AMR . AMR occurs when infectious organisms, such as bacteria and viruses, adapt to treatments and become resistant to them. The publication specifically addressed the long-known problem of antibiotic resistance, where increasing use of antibiotics can lead to the formation of “superbugs” that resist many of the antibiotic types we currently have. It outlined a variety of measures that are vital for ensuring we can still fight infections in the future and described how other major infectious diseases, such as tuberculosis, HIV, malaria and influenza, could one day become resistant to today’s treatment options.

However, despite the future danger posed by antimicrobial resistance, the situation is not irretrievable. As Dr Margaret Chan, director general of WHO, said: “much can be done. This includes prescribing antibiotics appropriately and only when needed, following treatment correctly, restricting the use of antibiotics in food production to therapeutic purposes and tackling the problem of substandard and counterfeit medicines.” The report also highlighted successful cases where antimicrobial resistance has been tackled, demonstrating that we can safeguard the effectiveness of important antimicrobial medicines with dedicated, rational efforts.

 

Where has the news come from?

WHO has just published a new report (“The evolving threat of antimicrobial resistance - Options for action” that sets out a global strategy for fighting antibiotic resistance. It explores how over past decades, bacteria that cause common infections have gradually developed resistance to each new antibiotic developed, and how AMR has evolved to become a worldwide health threat. In particular, the report highlights that there is currently a lack of new antibiotics in development and outlines some of the measures needed to prevent a potential global crisis in healthcare.

This is not the first time WHO has set out such a strategy. In the 2001, WHO published its “Global strategy for containment of antimicrobial resistance”, which laid out a comprehensive list of recommendations for combating AMR. The current report looks at the experiences over the past decade of implementing some of these recommendations, the progress made, and what else should be done to tackle AMR.

 

What is antimicrobial resistance?

Antimicrobial resistance (AMR occurs when microorganisms, such as bacteria, viruses, fungi or other microbes, develop resistance to the drug that is being used to treat them. This means that the treatment no longer effectively kills or inactivates the microorganism. The term “antimicrobial” is used to describe all drugs that treat infections caused by microorganisms. Antibiotics are effective against bacteria only, antivirals against viruses, and antifungals against fungi.

The case of penicillin illustrates the AMR phenomenon well. When penicillin was first introduced in the 1940s, it revolutionised medicine and was effective against a wide range of staphylococcal and streptococcal bacteria. It was also able to treat infections that had previously been fatal for many people, including throat infections, pneumonia and wound infections. However, with increasing use of antibiotics over the decades, bacteria began to adapt and develop changes in their DNA that meant they were resistant to the actions of the once powerful antibiotic. These bacteria would survive and proliferate, which meant their protective genes would then be passed on to other strains of bacteria. As a result, new and stronger antibiotics had to be created to combat the resistant bacteria.

AMR is driven by many factors, including overuse of antimicrobials for human and animal health and in food production, which can allow microbes to adapt to antimicrobials they are exposed to. Poor infection-control measures, which fail to prevent the spread of infections, also contribute. In particular, the WHO publication reports what it describes as the five most important areas for the control of AMR, as recognised in its 2001 strategy:

  • surveillance of antimicrobial use
  • rational use in humans
  • rational use in animals
  • infection prevention and control
  • innovations in practice and new antimicrobials

 

How big is the problem?

As the report describes, AMR makes it difficult and more expensive to treat many common infections, causing delays in effective treatment or, in the worst cases, an inability to provide effective treatment at all. Many patients around the world suffer harm because infections from bacteria, viruses, fungi or other organisms can no longer be treated with the common medicines that would once have treated them effectively.

The report presents some startling facts on major infectious diseases worldwide:

  • Malaria: malaria is caused by parasites that are transmitted into the bloodstream by a bite from an infected mosquito. Resistance to antimalarial medicines has been documented for all classes of the drug, which presents a major threat to malaria control. The report describes that a change in national antimalarial treatment policy is recommended when the overall treatment failure rate exceeds 10%. Changes in policy have been necessary in many countries due to the emergence of chloroquine resistance. This means that alternative forms of combination therapy have to be used as first-line treatment.
  • Tuberculosis: in 2010, an estimated 290,000 new multidrug-resistant tuberculosis (TB cases were detected among the TB cases notified worldwide, and about one-third of these patients may die annually. Inaccuracies in diagnosis also impede appropriate treatment.
  • HIV: resistance rates to anti-HIV drug regimens ranging from 10% to 20% have been reported in Europe and the USA. Second-line treatments are generally effective in patients when the first-line therapy has failed, but can only be started promptly if viral monitoring is routinely available.
  • Common bacterial infections: various bacteria can cause infections within the chest, skin and urinary tract bloodstream, for example, and the inability to fight these infections appears to a growing problem in healthcare. Estimates from Europe are that there are 25,000 excess deaths each year due to resistant bacterial hospital infections, and approximately 2.5 million avoidable days in hospital caused by AMR. In addition, the economic burden from additional patient illness and death is estimated to be at least ˆ1.5 billion each year in healthcare costs and productivity losses.

 

What can be done about AMR?

The five key areas that the report highlights could tackle the problem of AMR are as follows:

 

Surveillance of antimicrobial use

Tracking antimicrobial use (in particular antibiotic use and looking at the emergence and spread of resistant strains of bacteria is a key tactic in the fight against AMR. This can provide information, insights and tools needed to guide policy and measure how successful changes in prescribing may be. This can happen both locally and globally.

AMR is a global problem but, at present, there appears to be wide variation in the way regions and countries approach AMR surveillance. This means there is a long way to go before it can be carried out worldwide.

 

Rational use in humans

Antimicrobials can obviously be important or even lifesaving in appropriate situations, but it is just as important to prevent unnecessary use of antimicrobials, which can lead to resistance. Putting this into practice worldwide is said to be difficult, but rationalising antimicrobial use has had a demonstrable impact on AMR in some cases.

 

Rational use in animals

Antibiotics are said to be used in greater quantities in food production than in the treatment of disease in human patients. Also, some of the same antibiotics or classes are used in animals and in human medicine. This carries the risk of the emergence and spread of resistant bacteria, including those capable of causing infections in both animals and people.

The problems associated with the use of antibiotics in animal husbandry, including in livestock, poultry and fish farming, are reportedly growing worldwide without clear evidence of the need for or benefit from it. There are said to be major differences in the amounts of antimicrobials used per kilogram of meat produced in high-income countries, and actions need to be taken by national and international authorities to control this.

 

Infection prevention and control in healthcare facilities

The hospital environment favours the emergence and spread of resistant bacteria. The report highlights the importance of infection-control measures to prevent the spread of microbes in general, regardless of whether they are resistant to antimicrobials. Many facilities and countries are reported to have progressed well since 2001, implementing many recommendations on infection control and prevention, although gaps and challenges still remain.

 

Innovations

Lastly, the report describes how innovative strategies and technologies are needed to address the lack of new antimicrobials being produced. As the report says, while antimicrobials are the mainstay of treatment for infections, diagnostics and vaccines play important complementary roles by promoting rational use of such medicines and preventing infections that would require antimicrobial treatment. So far, new products coming on to the market have not kept pace with the increasing needs for improvements in antimicrobial treatment. However, current challenges to new research developments can be both scientific and financial.

 

Can these strategies really stop AMR?

While AMR poses a significant threat to health in the future, the situation does not appear to be irretrievable. The WHO report and an accompanying press release highlight some examples of success stories over the past years:

  • In Thailand, the "Antibiotic Smart Use" programme is reported to have reduced both the prescribing of antibiotics by prescribers and the demand for them by patients. It demonstrated an 18–46% decrease in antibiotic use, while 97% of targeted patients were reported to have recovered or improved regardless of whether they had taken antibiotics.
  • A pharmacy programme in Vietnam reportedly consisted of inspection of prescription-only drugs, education on pharmacy treatment guidelines and group meetings of pharmacy staff. These measures were reported to give significant reduction in antibiotic dispensing for acute respiratory infections.
  • In Norway, the introduction of effective vaccines in farmed salmon and trout, together with improved fish health management, was reported to have reduced the annual use of antimicrobials in farmed fish by 98% between 1987 and 2004.
  • In 2010, the University of Zambia School of Medicine was reported to have revised its undergraduate medical curriculum. AMR and rational use of medicines were made key new topics to ensure that graduates who enter clinical practice have the right skills and attitudes to be both effective practitioners and take a role in fighting AMR.  

 

How can I help?

There are times when antibiotics are necessary or even vital. However, as patients and consumers, it is important to remember that antibiotics or other antimicrobials are not always needed to treat our illnesses, and we should not expect them in every situation.

For example, the common cold is caused by a virus, which means it does not respond to antibiotics. However, people may expect to be given antibiotics by their doctor when they are affected, even though they offer no direct benefit and could raise the risk of bacteria becoming resistant. Furthermore many common viral and bacterial infections such as coughs, throat and ear infections and stomach upsets, are “self-limiting” in healthy people, which means they will generally get better with no treatment at all.

If, on the other hand, you are prescribed an antimicrobial, it is important to take the full course as directed. Taking only a partial course of an antimicrobial may not kill the organism but may expose it to a low dose of a drug which can then contribute to resistance.

Links To The Headlines

Health chief warns: age of safe medicine is ending. The Independent, March 16 2012

Resistance to antibiotics could bring "the end of modern medicine as we know it", WHO claim. The Daily Telegraph, March 16 2012

Why a sore throat could soon be fatal: Bugs are becoming more resistant to antibiotics, warn health chiefs. Daily Mail, March 16 2012

Links To Science

WHO: The evolving threat of antimicrobial resistance - Options for action. March 16 2012




19.03.2012 20:19:42
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18.03.2012 20:23:00
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19.03.2012 20:46:46
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18.03.2012 21:00:00
Fingolimod, the first ever MS (multiple sclerosis pill, will soon be recommended by the UK's National Institute for Clinical Excellence (NICE . NICE is a UK government body which decides which therapies should be covered by the National Health Service, the country's universal health care system. Fingolimod, brand name Gilenya, is made and marketed by Swiss pharmaceutical giant, Novartis...

Saturday, March 17, 2012

News and Events - 18 Mar 2012




16.03.2012 18:10:00

Case Number: AUTH/2424/8/11 and AUTH/2425/8/11
Case Ref: General Practitioner v Boehringer Ingelheim and Lilly
Description: Sponsored article on linagliptin
Breach: Lilly No breach, Boehringer Ingelheim Breaches Clauses 2, 3.1, 7.2, 7.4, 7.9, 7.10, 9.10 and 12.1
Appeal: Appeal by complainant - AUTH/2425/8/11
Review: Published in the February 2012 Review
Complaint Received: 03 August 2011
Complaint Completed: 04 October 2011

Case Summary:

A general practitioner complained that an article on linagliptin published in Future Prescriber represented the exaggerated, misleading and disguised promotion of linagliptin before a UK marketing authorization had been granted.

The article ‘Linagliptin: new class of DPP-4 [dipeptidyl peptidase-4] inhibitor in the treatment of T2DM [type 2 diabetes mellitus]’ was written by two diabetes and endocrinology physicians. A declaration of the authors’ interests was given in the final paragraph which stated ‘Placement of this article has been funded by Boehringer Ingelheim and Lilly. The content has been independently commissioned by Future Prescriber and has been checked by Boehringer Ingelheim and Lilly for factual accuracy only. Editorial control of this article remains with Future Prescriber’.

The complainant stated that the authors had previously received support from the companies which suggested that their opinions were likely to be known by both the companies which were likely to have been involved in their selection and briefing.

The complainant noted that the article stated that linagliptin was now approved and due to launch in the UK; this was not so. Linagliptin had only received a positive opinion from the European Medicines Agency (EMA .

The complainant alleged that the title of the article was misleading and exaggerated. He knew of no recognised or accepted sub-class of DPP-4 inhibitors. The title suggested an unqualified and unsubstantiated superiority over currently licenced DPP-4 inhibitors, comparisons with which were made throughout the article. The complainant asked if it was accurate to compare the maximal efficacy and potency of linagliptin with other DPP-4 inhibitors or claim that, in relation to use with concomitant medicines, linagliptin was safer than saxagliptin (Onglyza ; especially given that there were no head-to-head data with other DPP-4 inhibitors to substantiate this.

The complainant alleged that the claim that linagliptin might have a positive and long enduring effect on beta-cell function and therefore glycaemic control was misleading and inaccurate; this was not a fact nor could it be substantiated. The complainant stated that an unbalanced anddistorted promotional message was also elaborated with regard to renal acceptability. Saxagliptin was currently the only DPP-4 inhibitor with a UK licence for use in moderate/severe renal impairment. The complainant further alleged that the discussion of the possible cost of linagliptin compared with other DPP-4 inhibitors was not factual and potentially misled about cost-efficacy.

The complainant alleged that the decision to fund the development of this article and the evident lack of proper scrutiny of the facts suggested that the companies were keen to promote linagliptin prior to licence.

The detailed responses from Boehringer Ingelheim and Lilly are given below.

The Panel noted that it was acceptable for companies to sponsor material. It had previously been decided that the content would be subject to the Code if it was promotional in nature or if the company had used the material for a promotional purpose. Even if neither of these applied, the company would be liable if it had been able to influence the content of the material in a manner favourable to its own interests. It was possible for a company to sponsor material which mentioned its own products and not be liable under the Code for its contents, but only if it had been a strictly arm’s length arrangement with no input by the company and no use by the company of the material for promotional purposes.

The Panel noted that the publishers of Future Prescriber has proposed inter alia, two complementary articles (one of which was the article in question as part of the ‘managed entry programme’ for linagliptin ‘to support the product’ and ‘prepare the market’. It was proposed that the article in question would examine current and future treatment options with particular focus on the DPP-4 class and forthcoming products. The proposal also stated that the article would be independently commissioned, peer reviewed and published within the main pages of the journal. There would be no input from the company other than for medical accuracy. Reprints would be made available following publication. Minutes of a meeting between Boehringer Ingelheim the publishers and Lilly once the complaint had been received stated, inter alia, that the agreement with the publisher was that it would take all responsibility for generation of the article, choosing of authors (although it could requestinput from Boehringer Ingelheim, as it had done in relation to the article in question, but the publishers had made the final choice , managing the writing and review process and publication of the final article.

The Panel considered that it was clear from the proposal that the article would support linagliptin, and that Boehringer Ingelheim would have known this at the outset.

It appeared that although Boehringer Ingelheim did not pay for the article per se, it in effect commissioned it through an agreement to pay for 2,000 reprints. The Panel considered that Boehringer Ingelheim was inextricably linked to the production of the article and the company was responsible under the Code for the content.

Turning to the article itself, the Panel noted that the only mention of Boehringer Ingelheim was at the end of the article, after citation of all the references. The Panel considered that the article did not clearly indicate the involvement of the company, and ruled a breach of the Code. As the content was promotional, the Panel considered that it was disguised in that regard and ruled a breach of the Code.

The Panel noted that the article stated that linagliptin was approved in the UK. When the article was published, the product had not received a marketing authorization. The statement in relation to its licence was therefore inaccurate, and a breach of the Code was ruled. In addition, the article promoted a medicine prior to the grant of a marketing authorization and the Panel ruled a breach of the Code. As linagliptin did not have a marketing authorization, and therefore did not have a summary of product characteristics (SPC at the time of publication, the Panel did not consider that the article promoted the medicine outwith the terms of its marketing authorization or inconsistently with its SPC, and ruled no breach of the Code.

On the evidence before it, the Panel did not consider that linagliptin represented a new class of DPP-4 inhibitors. The title of the article implied that the medicine had some special merit, which could not be substantiated, and the Panel ruled breaches of the Code.

The article made it clear that there were currently no head-to-head trials of linagliptin with other DPP-4 inhibitors. The Panel did not consider that the article made misleading comparisons of the efficacy of linagliptin and other DPP-4 inhibitors as alleged and ruled no breach of the Code.

The Panel noted that the article stated that as linagliptin did not interfere with CYP450 it was ‘safer to use’ concomitantly with certain medications than saxagliptin. Given that there was no head-to-head trial of linagliptin and saxagliptin, the Panel considered that this claimdid not reflect available evidence and was not capable of substantiation by clinical experience, and ruled a breach of the Code.

The Panel noted the complainant’s comments in relation to the effect on beta-cell function of linagliptin and renal acceptability of the medicine. The Panel did not know whether any of these claims were correct. The Panel noted that the complainant bore the burden of proof. The Panel also noted its comment above that the company was responsible for the article. The Panel considered that as the product did not have a marketing authorization at the time the article was published, its ruling above of a breach of the Code covered these allegations.

 With regard to the allegation that the information about possible cost of linagliptin compared with other DPP-4 inhibitors was not factual and potentially misled in relation to the cost-efficacy of the medicine, the Panel noted that the complainant had not explained why the claim at issue was inaccurate. There was no actual or implied cost-efficacy claim. No breach of the Code was ruled. This ruling was unsuccessfully appealed by the complainant.

The Panel considered that Boehringer Ingelheim would have been aware at the outset of the promotional content of the article. For the company to consider it anything other than a promotional item demonstrated a serious lack of understanding of the Code. High standards had not been maintained and ruled a breach of the Code. The Panel considered that Boehringer Ingelheim’s involvement with the publication brought discredit upon and reduced confidence in the pharmaceutical industry, and ruled a breach of Clause 2.

 In relation to Lilly’s involvement with, and responsibility for, the article, the Panel noted that at the time the content of the article was agreed, Lilly and Boehringer Ingelheim had not formed a co-marketing alliance. The proposal for the article in question was sent only to Boehringer Ingelheim and only Boehringer Ingelheim was mentioned in the title of the proposal. Lilly was not aware of the article until it was contacted by Boehringer Ingelheim. Given the exceptional circumstances the Panel did not consider that Lilly was responsible for the article at issue, and ruled no breach of the Code.

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16.03.2012 20:38:00


  1. Ganapati Mudur

Author Affiliations

India’s controller of patents has granted the country’s first compulsory licence on a patented drug, allowing a domestic drug company to manufacture a generic version of Bayer’s sorafenib tosylate (marketed as Nexavar , used in chemotherapy for hepatic and renal cancers.

Natco Pharma asked for the right to manufacture sorafenib tosylate, saying that it would make available a generic version that would cost patients 8800 rupees (?110; ˆ135; $175 a month rather than the 280?000 rupees a month it costs for Bayer’s product. The controller granted the licence and ruled that Natco Pharma should pay Bayer a royalty fee of 6% on sales of the generic version.

Experts in public health who have been campaigning for better access to inexpensive generic drugs have hailed the controller’s decision, but sections of the pharmaceutical industry have said that compulsory licensing should be invoked only in public health emergencies and not to reduce the prices of drugs.

Bayer, which has the right to appeal, has said it is disappointed by the decision.

However, patient support groups are looking forward to more compulsory licences in other therapeutic areas. Yogendra Sapru, chief executive of the Cancer Patients Aid Association, said in a statement released after the controller’s decision this week, “Many other cancer medicines are sold at exorbitant prices in India.”

A single vial of patented trastuzumab (Herceptin , which is used in combination with paclitaxel to treat metastatic breast cancer, costs about 132?000 rupees in India, says a report from the Centre for Trade and Development, a policy think tank in New Delhi.

Malluparambil Santhosh, associate fellow at the think tank, said, “Herceptin chemotherapy in India is currently beyond the reach of the vast majority of patients who need it.”

A patented version of interferon used to treat hepatitis C virus infection is another example of a drug that most patients can’t afford, he said.

A senior health economist said that India will need to use all available tools to reduce prices of drugs given the government’s plans to introduce universal healthcare, including free drugs, announced last year (
BMJ
2011;343:d6774, doi:
10.1136/bmj.d6774 .

Sakthivel Selvaraj, an economist with the Public Health Foundation of India, New Delhi, said, “Compulsory licensing fits in with the goal of government procurement of drugs and distribution of free medicines for inpatient and outpatient healthcare.”

India changed its patent laws in 2005 to allow product patents on drugs, including the provision of compulsory licensing—as have other countries, as this is allowed under World Trade Organization rules. Brazil and Thailand have already used compulsory licences to make available antiretrovirals and anticancer drugs to their populations.

“India has been lagging behind on compulsory licensing despite huge expenses on drugs,” Dr Selvaraj told the
BMJ
. A nationwide survey of healthcare spending has shown that expenditure on drugs had accounted for about 68% of total personal spending on healthcare in India between April 2009 and March 2010.

The Organisation of Pharmaceutical Producers of India, which mainly represents international drug companies, has said that it has no objection to the use of compulsory licensing in a national emergency but believes that broadening its scope for “affordability” could result in the abuse of this provision.

India’s Association of Biotechnology Led Enterprises has said that it supports strong protection of intellectual property and opposes compulsory licences on “frivolous” grounds. “The government should clearly specify the criteria for issuing compulsory licences,” said Nandita Chandavarkar, its director of operations.

But health groups say that such reactions are predictable. “The idea that compulsory licensing should be limited only to emergencies is a myth promoted by multinational companies,” said Anand Grover, a director of Lawyers Collective, a non-government organisation that has represented cancer and HIV patients’ groups in court.

Mr Grover said that members of the World Trade Organization, including the United States and the European Union, had signed the Doha Declaration in 2001, which recognises the right to grant compulsory licences and the freedom to determine the grounds on which such licences are granted.

“India is likely to experience intense pressure from the developed countries and multinational corporations in the coming weeks to go slow on compulsory licensing,” said the Centre for Trade and Development’s Mr Santhosh.

Notes

Cite this as:
BMJ
2012;344:e2132

via
bmj.com

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16.03.2012 13:01:03
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17.03.2012 1:10:00

A claim for restitution filed by Pennsylvania's attorney general caused a last-minute delay in the sentencing of
Merck & Co. (MRK for its violation of a federal drug law in connection with its marketing of former painkiller Vioxx.

At a hearing Friday in federal court in Boston, U.S. District Judge Patti Saris delayed Merck's sentencing until April 19 to allow for more time to consider the Pennsylvania claim. Merck was originally scheduled to be sentenced Friday.

Merck, of Whitehouse Station, N.J., agreed in November to pay $950 million and plead guilty to a misdemeanor charge of marketing a misbranded drug, to resolve government allegations that the company illegally promoted Vioxx and deceived the government about the drug's safety.

The government alleged Merck promoted Vioxx for treatment of rheumatoid arthritis before that use was approved by regulators. A portion of the $950 million settlement also was to resolve parallel civil allegations that Merck made false and misleading statements about Vioxx's safety, causing government health programs to pay for the drug's use. Merck denied the civil allegations.

Merck had withdrawn Vioxx from the market in 2004 after a study showed it increased the risk of heart attacks and other cardiovascular events.

The proposed November settlement was to resolve claims by the U.S.
Justice Department, more than 40 states and the District of Columbia.

But last week, the Commonwealth of Pennsylvania filed a so-called victim impact statement with the court. Pennsylvania's attorney general office argued that Judge Saris shouldn't impose a sentence unless Pennsylvania obtains restitution for
Medicaid payments allegedly resulting from Merck's criminal misconduct, according to a court document filed by the U.S. Justice Department.

Pennsylvania is continuing to pursue Vioxx-related claims against Merck in proceedings coordinated by a federal judge in Louisiana, according to the Justice Department.

The Justice Department argued that Pennsylvania therefore has a forum to pursue its claims, and it shouldn't hold up the sentencing in Boston.

Merck also urged Judge Saris to decline Pennsylvania's application for restitution because it would delay distribution of the settlement money to participating states.

In a written statement Friday, Merck said: "Through a last minute request the Commonwealth of Pennsylvania has attempted to derail an agreement already reached in good faith with the federal government, 44 other states, and the District of Columbia. There is no legal foundation for the Commonwealth's claim in this court and Merck will vigorously oppose it."

The Justice Department said Pennsylvania was allocated $4.5 million for alleged Medicaid losses under the $950 million settlement. States had the choice of either accepting their allocations or initiating or continuing litigation against Merck.

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NHS Choices
16.03.2012 21:00:00

“Human resistance to antibiotics could bring ‘the end of modern medicine as we know it’,” according to The Daily Telegraph. The newspaper says that we are facing an antibiotic crisis that could make routine operations impossible and a scratched knee potentially fatal. Similarly, the Daily Mail’s headline stated that a sore throat could soon become fatal.

The alarming headlines follow a new report by the World Health Organization (WHO , which set out ways to fight the growing problem of antimicrobial resistance (AMR . AMR occurs when infectious organisms, such as bacteria and viruses, adapt to treatments and become resistant to them. The publication specifically addressed the long-known problem of antibiotic resistance, where increasing use of antibiotics can lead to the formation of “superbugs” that resist many of the antibiotic types we currently have. It outlined a variety of measures that are vital for ensuring we can still fight infections in the future and described how other major infectious diseases, such as tuberculosis, HIV, malaria and influenza, could one day become resistant to today’s treatment options.

However, despite the future danger posed by antimicrobial resistance, the situation is not irretrievable. As Dr Margaret Chan, director general of WHO, said: “much can be done. This includes prescribing antibiotics appropriately and only when needed, following treatment correctly, restricting the use of antibiotics in food production to therapeutic purposes and tackling the problem of substandard and counterfeit medicines.” The report also highlighted successful cases where antimicrobial resistance has been tackled, demonstrating that we can safeguard the effectiveness of important antimicrobial medicines with dedicated, rational efforts.

 

Where has the news come from?

WHO has just published a new report (“The evolving threat of antimicrobial resistance - Options for action” that sets out a global strategy for fighting antibiotic resistance. It explores how over past decades, bacteria that cause common infections have gradually developed resistance to each new antibiotic developed, and how AMR has evolved to become a worldwide health threat. In particular, the report highlights that there is currently a lack of new antibiotics in development and outlines some of the measures needed to prevent a potential global crisis in healthcare.

This is not the first time WHO has set out such a strategy. In the 2001, WHO published its “Global strategy for containment of antimicrobial resistance”, which laid out a comprehensive list of recommendations for combating AMR. The current report looks at the experiences over the past decade of implementing some of these recommendations, the progress made, and what else should be done to tackle AMR.

 

What is antimicrobial resistance?

Antimicrobial resistance (AMR occurs when microorganisms, such as bacteria, viruses, fungi or other microbes, develop resistance to the drug that is being used to treat them. This means that the treatment no longer effectively kills or inactivates the microorganism. The term “antimicrobial” is used to describe all drugs that treat infections caused by microorganisms. Antibiotics are effective against bacteria only, antivirals against viruses only, and antifungals against fungi.

The case of penicillin illustrates the AMR phenomenon well. When penicillin was first introduced in the 1940s, it revolutionised medicine and was effective against a wide range of staphylococcal and streptococcal bacteria. It was also able to treat infections that had previously been fatal for many people, including throat infections, pneumonia and wound infections. However, with increasing use of antibiotics over the decades, bacteria began to adapt and develop changes in their DNA that meant they were resistant to the actions of the once-powerful antibiotic. These bacteria would survive and proliferate, which meant their protective genes would then be passed on to other strains of bacteria. As a result, new and stronger antibiotics had to be created to combat the resistant bacteria.

AMR is driven by many factors, including overuse of antimicrobials for human and animal health and in food production, which can allow microbes to adapt to antimicrobials they are exposed to. Poor infection-control measures, which fail to prevent the spread of infections, also contribute. In particular, the WHO publication reports what it describes as the five most important areas for the control of AMR, as recognised in its 2001 strategy:

  • surveillance of antimicrobial use
  • rational use in humans
  • rational use in animals
  • infection prevention and control
  • innovations in practice and new antimicrobials

 

How big is the problem?

As the report describes, AMR makes it difficult and more expensive to treat many common infections, causing delays in effective treatment or, in the worst cases, an inability to provide effective treatment at all. Many patients around the world suffer harm because infections from bacteria, viruses, fungi or other organisms can no longer be treated with the common medicines that would once have treated them effectively.

The report presents some startling facts on major infectious diseases worldwide:

  • Malaria: malaria is caused by parasites that are transmitted into the blood stream by a bite from an infected mosquito. Resistance to antimalarial medicines has been documented for all classes of the drug, which presents a major threat to malaria control. The report describes that a change in national antimalarial treatment policy is recommended when the overall treatment failure rate exceeds 10%. Changes in policy have been necessary in many countries due to the emergence of chloroquine resistance. This means that alternative forms of combination therapy have to be used as first-line treatment.
  • Tuberculosis: in 2010, an estimated 290,000 new multidrug-resistant tuberculosis (TB cases were detected among the TB cases notified worldwide, and about one-third of these patients may die annually. Inaccuracies in diagnosis also impede appropriate treatment.
  • HIV: resistance rates to anti-HIV drug regimens ranging from 10% to 20% have been reported in Europe and the USA. Second-line treatments are generally effective in patients when the first-line therapy has failed, but can only be started promptly if viral monitoring is routinely available.
  • Common bacterial infections: various bacteria can cause infections within the chest, skin and urinary tract bloodstream, for example, and the inability to fight these infections appears to a growing problem in healthcare. Estimates from Europe are that there are 25,000 excess deaths each year due to resistant bacterial hospital infections, and approximately 2.5 million avoidable days in hospital caused by AMR. In addition, the economic burden from additional patient illness and death is estimated to be at least ˆ1.5 billion each year in healthcare costs and productivity losses.

 

What can be done about AMR?

The five key areas that the report highlights could tackle the problem of AMR are as follows:

 

Surveillance of antimicrobial use

Tracking antimicrobial use (in particular antibiotic use and looking at the emergence and spread of resistant strains of bacteria is a key tactic in the fight against AMR. This can provide information, insights and tools needed to guide policy and measure how successful changes in prescribing may be. This can happen both locally and globally.

AMR is a global problem but, at present, there appears to be wide variation in the way regions and countries approach AMR surveillance. This means there is a long way to go before it can be carried out worldwide.

 

Rational use in humans

Antimicrobials can obviously be important or even lifesaving in appropriate situations, but it is just as important to prevent unnecessary use of antimicrobials, which can lead to resistance. Putting this into practice worldwide is said to be difficult, but rationalising antimicrobial use has had a demonstrable impact on AMR in some cases.

 

Rational use in animals

Antibiotics are said to be used in greater quantities in food production than in the treatment of disease in human patients. Also, some of the same antibiotics or classes are used in animals and in human medicine. This carries the risk of the emergence and spread of resistant bacteria, including those capable of causing infections in both animals and people.

The problems associated with the use of antibiotics in animal husbandry, including in livestock, poultry and fish farming, are reportedly growing worldwide without clear evidence of the need for or benefit from it. There are said to be major differences in the amounts of antimicrobials used per kilogram of meat produced in high-income countries, and actions need to be taken by national and international authorities to control this.

 

Infection prevention and control in healthcare facilities

The hospital environment favours the emergence and spread of resistant bacteria. The report highlights the importance of infection-control measures to prevent the spread of microbes in general, regardless of whether they are resistant to antimicrobials. Many facilities and countries are reported to have progressed well since 2001, implementing many recommendations on infection control and prevention, although gaps and challenges still remain.

 

Innovations

Lastly, the report describes how innovative strategies and technologies are needed to address the lack of new antimicrobials being produced. As the report says, while antimicrobials are the mainstay of treatment for infections, diagnostics and vaccines play important complementary roles by promoting rational use of such medicines and preventing infections that would require antimicrobial treatment. So far, new products coming on to the market have not kept pace with the increasing needs for improvements in antimicrobial treatment. However, current challenges to new research developments can be both scientific and financial.

 

Can these strategies really stop AMR?

While AMR poses a significant threat to health in the future, the situation does not appear to be irretrievable. The WHO report and an accompanying press release highlight some examples of success stories over the past years:

  • In Thailand, the "Antibiotic Smart Use" programme is reported to have reduced both the prescribing of antibiotics by prescribers and the demand for them by patients. It demonstrated an 18–46% decrease in antibiotic use, while 97% of targeted patients were reported to have recovered or improved regardless of whether they had taken antibiotics.
  • A pharmacy programme in Vietnam reportedly consisted of inspection of prescription-only drugs, education on pharmacy treatment guidelines and group meetings of pharmacy staff. These measures were reported to give significant reduction in antibiotic dispensing for acute respiratory infections.
  • In Norway, the introduction of effective vaccines in farmed salmon and trout, together with improved fish health management, was reported to have reduced the annual use of antimicrobials in farmed fish by 98% between 1987 and 2004.
  • In 2010, the University of Zambia School of Medicine was reported to have revised its undergraduate medical curriculum. AMR and rational use of medicines were made key new topics to ensure that graduates who enter clinical practice have the right skills and attitudes to be both effective practitioners and take a role in fighting AMR.  

 

How can I do my part?

There are times when antibiotics are necessary or even vital. However, as patients and consumers, it is important to remember that antibiotics or other antimicrobials are not always needed to treat our illnesses, and we should not expect them in every situation.

For example, the common cold is caused by a virus, which means it does not respond to antibiotics. However, people may expect to be given antibiotics by their doctor when they are affected, even though they offer no direct benefit and could raise the risk of bacteria becoming resistant. Furthermore many common viral and bacterial infections such as coughs,  throat and ear infections and stomach upsets, are “self-limiting” in healthy people, which means they will generally get better with no treatment at all.

If, on the other hand, you are prescribed an antimicrobial, it is important to take the full course as directed. Taking only a partial course of an antimicrobial may not kill the organism but may expose it to a low dose of a drug which can then contribute to resistance.

Links To The Headlines

Health chief warns: age of safe medicine is ending. The Independent, March 16 2012

Human resistance to antibiotics could bring "the end of modern medicine as we know it", WHO claim. The Daily Telegraph, March 16 2012

Why a sore throat could soon be fatal: Bugs are becoming more resistant to antibiotics, warn health chiefs. Daily Mail, March 16 2012

Links To Science

WHO: The evolving threat of antimicrobial resistance - Options for action. March 16 2012




16.03.2012 13:04:12
Face it, this year you will have to 'do more with less'. SFE US 2012 will show you how......Pharma is in flux. That's an understatement. Customers have evolved, pipelines have shrunk, thousands of stakeholders need attention and budgets are restricted. The sales and marketing rule book is being completely rewritten. But it's not all bad... The speed of customer change is driving unprecedented innovation Right now, we're questioning 'norms', revisiting 'proven' tactics, looking for new approaches. "It's not about shiny new iPads, but changing the way we look at our customers and taking advantage of all of the opportunities available to us.." - Andreas Claus Kistner, Global Head of Commercial Architecture, Roche.



17.03.2012 18:58:49
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16.03.2012 23:00:42

The top executives at Abbott see their pay packages decline by a collective 24%; also, Allezoe replaces suspect secretary White; Stereotaxis COO/CTO steps down; and iCad holds on to marketing SVP.

MassDevice.com Personnel Moves

The top brass at
Abbott (NYSE:
ABT saw their 2011 pay packages reduced by a collective 23.9%, ranging from a 6.1% cut for chairman & CEO Miles White to a whopping 26.9% hit for pharma head Richard Gonzalez.



read more

http://www.massdevice.com/news/abbott-brass-takes-pay-cuts-personnel-moves#comments

Thursday, March 15, 2012

News and Events - 16 Mar 2012




15.03.2012 22:12:46


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15.03.2012 18:16:00

GlaxoSmithKline 
(NYSE:GSK has agreed to market some of its over-the-counter brands in Europe to Omega Pharma.

Belgium-based Omega Pharma is paying $614 million for brands such as stomach antacid Zantac and Nytol cold and allergy medicine .

Part of the deal includes transferring GSK’s Herrenberg, Germany factory to Omega Pharma.

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15.03.2012 10:16:43
Stay well Group India?s fastest growing company. We are a Rajasthan based & professionally managed pharmaceutical & Agro Food Company. We offer a wide range of highest quality & best packaged products manufactured .This is an ISO certified company. Stay well Company Manufactured in Cattle Feed (Pellets, Mass & Calcium, Milk Fat growing Supplements & Fmcg and Pharma products like (protein powder, Liquid Syrups, Herbals . Today this company is Present in 7 states with 32 centers across India (Owned and C&F and by the year of end there will be more as we plan to expand to over 100 centers in 50 cities. We are Inviting Distributor & Retailers for Agro & Pharma Division of sales our quality products in your Area. Enquiries also welcome, interested parties may contact: www.staywellpharmaceuticals.com or staywellpharmaceuticals@gmail.com required only good parties with financial background & marketing experience are welcome for the marketing/distribution/franchisee in the unrepresented areas. Join to hand became a part of new age business opportunity. We are also provided job work like (Cattle Feed, Calcium & Milk fat supplements?, Herbals? based protein powder etc. of third party manufacturing of small batches .Or contact +91-141-4210050 ,8955846124; **Conditions Apply Staywell Pharmaceuticals Largest manufacture of cattle feed and pharma products offer business opportunity



13.03.2012 6:31:14

 

Biotecnika Info Labs Pvt Ltd, Bangalore is a Parent Company which runs India’s Largest Biosciences Career & education Portal. Biotecnika is where in technology meets life sciences.

“We are a fast growing Bio-techno-media company with extremely talented and fun Loving people you would love to work with. Biotecnika is run by a group of Doctorate & post Doctorates of lifesciences & together we help in the upliftment of postgraduates from any lifesciences background. If you do not like processes, hate pyramid type organizations; love creativity, innovation and fun at work; you will love it here. You will find a very flexible work environment, which treats people like human beings” 

  • Post: Business Development Executive
  • Company Name: Biotecnika Info Labs Pvt Ltd
  • Location: in Bengaluru/Bangalore
  • Experience: 0 to 3 yrs
  • Salary: INR 1,75,000 - 2,50,000 P.A
  • Opening(s : 5

Qualification & Duties

  • Must be a MSc graduate in Bioscience
  • 0 - 3 years Sales experience.
  • MBA preferred
  • Good written and oral communication
  • Client follow ups
  • Candidate should be willing to sell services and product.
  • Candidates have to generate leads, qualify the leads on the sales strategies, identify the potential client, client interaction and maintain client relationship.
  • Understanding the requirement of client and offering them with the appropriate services and product.
  • Follow up with clients.
  • Ability to meet multiple objectives within an organization.
  • Work on Online marketing, Social Media Marketing, Email marketing, Tele Marketing as well as Field marketing
  • Selling should be your signature statement.
  • Maintaining relationship with clients and providing business leads, client interaction, team building, follow up with clients.
  • Identify potential clients; manage existing account/customer relationships.
  • Understanding the requirements of the clients & positioning an appropriate Solution
  • Should be able to travel on demand as per the Company Policy.
  • Liaisoning with Colleges / institutes for upliftment of biosciences


Desired Candidate Profile
Education:(UG - Any Graduate - Any Specialization, B.Com, B.B.A, B.Pharma, B.Sc,

B.Tech
/B.E. AND (PG - MBA/PGDM - Advertising/Mass Communication, International Business, Marketing, Other Management,

M.Tech
- Bio-Chemistry/Bio-Technology, Biomedical,

M.Sc
- Bio-Chemistry

  • A minimum of 0 - 3 years of marketing experience
  • Good organizational skills and the ability to understand detailed information.
  • Basic IT and numeric skills.
  • Good interpersonal skills to form effective working relationships with people at all levels.
  • A proven track record of 'making a difference'.
  • Creative, resourceful, detail-oriented, highly organized.
  • Excellent verbal and written communication skills.
  • Good Presentation skills.
  • Time Management Skills.
  • The potential to handle a leadership role.
  • Candidate should have pleasing personality with excellent communication skills (Verbal & Written .
  • Only candidates who can relocate to bangalore may apply

Executive Name:Sylvia Fernandes
Contact Company: Biotecnika
Address: #2628, 4th Floor 27th Main, Sector 1 HSR Layout, Landmark - CPWD Quarters BANGALORE,Karnataka,India 560102
Apply to Email Address :
jobs@biotecnika.org
Telephone: 80-91-65705331
Reference Id: MAR-10-BDE
 



http://www.biotecnika.org/content/march-2012/sales-marketing-business-development-executives-required-biotecnika-info-labs-pvt#comments



14.03.2012 5:39:28

Gland Pharma Ltd. is a leading Pharmaceutical Company approved by USFDA, involved in Manufacturing and marketing of Small Volume Parenterals, Pre-filled syringes and other Pharmaceutical Products

Post : QA Chemist
Experience : 2 to 5 yrs
Job Desciption : 
a. Should have basic knowledge in sterile injecatble manufacturing.
b. Should be aware of current GMP(CRF/TGA/MCCMHRA requirements.
c. Good communication and dosumentation skills.
Education : M.Pharma,

M.Sc
- Bio-Chemistry,

Biotechnology
,

Microbiology

Desirable : Preference will be given to Sterile Injectable working area expereinced candidates.
Location : Hyderabad

Contact Details :
Contact Company : Gland Pharma Ltd
Location : Hyderabad
Email Address : hr@glandpharma.com

Deadline : 11.04.12



http://www.biotecnika.org/content/march-2012/gland-pharma-ltd-recruiting-qa-chemist-post-msc-biotechmicrobio-eligible#comments



14.03.2012 13:32:00

One Pennsylvania doctor in 2008 wrote 1,913 prescriptions for the antipsychotic drug Risperdal - a bit more than 5.2 per day in that leap year, counting weekends and holidays - costing Medicaid $341,273.71.

The top 10 prescribers in Pennsylvania's system that year wrote 9,557 Risperdal scripts costing Medicaid $1.76 million, according to figures provided by a state official to U.S. Sen. Charles Grassley (R., Iowa , who has pushed for disclosure of such information and the relationship between doctors and pharmaceutical companies.

The numbers raised questions for Grassley, and Pennsylvania officials sent letters to scores of doctors emphasizing the need for safety in prescribing antipsychotic drugs. Twelve were suspended, dropped from Medicaid, or are under investigation, according to a copy of a letter to Grassley released Tuesday by the state welfare department.

The numbers also play a role in the U.S. Department of Justice's efforts to fight health care fraud. In the case of Risperdal, the Justice Department is negotiating with Johnson & Johnson, whose Janssen subsidiary makes the drug, to address allegations that the company illegally promoted it to doctors and through Medicaid programs.

Medicaid is the taxpayer-funded insurance plan for poor Americans and is administered by the federal and state governments.

J&J previously disclosed that it set aside money to settle criminal and civil charges in the Risperdal litigation, though it had not specified the amount.

Reports over the weekend from the Wall Street Journal and Bloomberg News said the Justice Department had demanded a payment of about $1.8 billion, an increase from the $1 billion figure reportedly negotiated by the U.S. Attorney's Office in Philadelphia in December.

Spokesmen for J&J, the Justice Department, and the U.S. Attorney's Office declined to comment.

The $1.8 billion figure would be the largest settlement for a case involving a single drug, but some of the other big settlements also involved antipsychotic drugs.

"Both Sen. Grassley and the Department of Justice are making great headway in the battle against Medicaid fraud," said Allen Jones, the former investigator for Pennsylvania's Office of Inspector General whose findings were ignored by state officials in 2004.

Jones was fired by state officials when he took the information to the New York Times, but his whistle-blower lawsuit resulted in J&J's paying $158 million to settle charges that it illegally marketed Risperdal through the Texas Medicaid system. Jones will get a portion of that settlement. He now works as an adviser to attorneys in related litigation.

Eli Lilly & Co. paid $1.7 billion to settle charges of illegal marketing of its antipsychotic drug Zyprexa. Pfizer Inc. paid $2.3 billion to settle charges of illegal marketing of several drugs, notably Bextra, but also its antipsychotic Geodon. Late in 2011, GlaxoSmithKline P.L.C. said it had reached a deal to pay $3 billion to settle charges related to several drugs, including Avandia, but the Justice Department has declined to comment on that one as well.

Jones provided The Inquirer with state figures sent to Grassley's office in 2010 by Michael Nardone, then an official with the Pennsylvania Medical Assistance Program.

New Jersey never responded to Grassley's 2010 request for information nor a follow-up letter dated Jan. 24. State officials could not be reached for comment Tuesday. Delaware Medicaid officials responded to Grassley in 2010 and again in February.

J&J's Risperdal lost patent protection at the end of 2007, so the 2008 figures were the beginning of the decline in costs as generic versions were used more often.

As a comparison, AstraZeneca P.L.C.'s antipsychotic, Seroquel, is just now losing patent protection on most versions.

In 2008, the top 10 prescribers in Pennsylvania wrote 18,705 prescriptions for Seroquel, costing Medicaid $3.67 million. State officials provided The Inquirer with the most recent response to Grassley. That letter says the top 10 prescribers wrote 17,692 scripts for Seroquel, costing Medicaid $5.73 million.

In 2010, AstraZeneca paid $520 million to settle charge of illegal marketing of Seroquel.

"I liken the DOJ effort to a storm surge building for a long time," Jones said, crediting Grassley and a few others in Congress for helping to push the issue. "They have a clear eye on the dirty ways of fraudulent marketing and are systematically exposing it. It is changing the way antipsychotic drugs are marketed in America."

Contact David Sell at 215-854-4506 or
dsell@phillynews.com.

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Pharma International's US Correspondent
13.03.2012 11:48:07

The government in India has granted the rights to an indigenous pharmaceutical group to manufacture a generic version of the cancer treatment drug Nexavar.

For the first time, an Indian drugs firm has been approved to produce a medication under licence when the original's still patent-covered.

As a result of the agreement, the firm - Natco Pharma - is obliged to forward six per cent in royalties back to Bayer, which presently markets Nexavar alongside Onyx Pharmaceuticals.

Bayer, meanwhile - according to reports - isn't best pleased with the Indian government's move. "We are disappointed about this decision", company representative Sabrina Cusimano stated in comments made to the Associated Press. "We will see if we can further defend our intellectual property rights in India".

Nexavar Cancer Drug

Nexavar is the market name for sorafenib, an orally-taken medication now approved to treat two types of cancer - advanced hepatocellular carcinoma (liver cancer and advanced renal cell carcinoma (kidney cancer .

The kidney cancer approval came first, in 2005, when the US FDA declared its satisfaction with the product. It did the same for the drug as a liver cancer treatment two years later and, with clinical trials now in progress, thyroid cancer could be the next condition added to this approved treatment list.

Controversially, the drug's not available as a
UK liver cancer treatment, after being rejected - on grounds of cost - by the National Institute for Health and Clinical Excellence in November 2009.

Natco Generic Nexavar Approval

The Natco generic Nexavar approval decision will see the production of drug copies priced at the equivalent of £112 for a box of 120: less than £1.00 each. This is dramatically cheaper than the original drug, with the same quantity presently priced at over 30 times that cost.

The Indian pharmaceutical firm believes that the drug's availability is key to the treatment of close to 9,000 cancer patients in India.

"This is a victory for Indian patients and for India's generic manufacturers, which are under attack", Natco Pharma's General Manager, Madineedi Adinarayana, stated according to the BBC, adding: "many more such cases will follow."




15.03.2012 20:51:23
Formulator (Pharmaceutical
West Yorkshire.
?19,000 - ?24,000

My client is an established and growing pharmaceutical company. They are currently looking for an addition to their Formulation team, reporting to the formulation team leader.

The main responsibility of the role is to develop suitable and stable formulations and processes using formulation aids and processing techniques. To support Analytical Development throughout Formulation Development.

To develop robust and stable formulations for new products that complies with the requirements of marketing.
Multi-project management of new formulations, from initial project approval through to successful production scale up, and licence regulatory submission (where applicable .
Liaise with multiple departments to facilitate new product introduction.
To produce process development protocols and reports to provide evidence of robust product manufacture.
To produce outline methods of manufacture for production.
To ensure that the batch size and methods of manufacture are of sufficient scale necessary to fulfil the marketing requirement, achieved by supervision of batch manufacture (In conjunction with production .
To produce specifications for new raw materials and new products.
To produce reports to support process development and validation activities.
To produce documentation which ensures that stability requirements are met.
To provide support for MA applications, providing information for Development Pharmaceutics reports as directed by Regulatory requirements.
To characterise suspensions with respect to particle size and rheological properties, providing supporting data and reports described above to support MA applications.
To review existing products and processes, recommending improvements, as new techniques become available.
Ensure all work performed complies with GLP, cGMP where applicable.
To keep accurate records of all work undertaken as per internal/external procedures/guidelines.

The successful applicant for this role will hold a BSc. in Pharmacy or a related subject with experience in pharmaceutical formulation. Experience of oral liquid dosage would be desired but not necessary.

If you are interested in applying for this role, then please forward your CV to: Brendan Rogers at PULSE Scientific.



14.03.2012 5:38:46

Post : Business Analyst in Pharmaceutical Research

Experience : 0 to 2 yrs

Job Desciption : 
a. Track the pharmaceutical, biotech and medical devices industry, especially therapeutic areas/modalities of interest to our regular clients
b. Understand project brief given by clients/project leaders, create analysis plan, data requirements, research approach, and prepare reports or executive presentations with key insights and recommendations
c. Report to project leader/consultant and assist in executing or execute the projects completely depending on complexity and scale
Education :

M.Sc
- Bio-Chemistry,

Biotechnology
,

Life Science

Salary : INR 1,75,000 - 2,50,000 P.A. The CTC is exclusive of Performance Bonus



Desirable : 
a. High level of comfort with MS Excel, Power Point, ability to perform basic calculations (basic financial, statistical and data manipulation understand sales and marketing performance metrics, basic data cleaning and organizing, ability to create meaningful charts/ visual representation to simplify complex analyses.
b. Web search, high level of familiarity with life sciences lexicon, regulatory framework for
pharmaceuticals and biotech
c. Attention to detail, accuracy, business relevance in analysis and report writing/executive
presentation skills

Location : Bangalore

Contact Details :
Executive Name : Ravi Prakash
Stratycon Business Solutions Pvt Ltd
Address : 14th cross, 2nd block,
Jayanagar Bangalore,Karnataka,India 560011
Email Address : raviprakash@stratycon.com

Deadline : 09.04.12



http://www.biotecnika.org/content/march-2012/immediate-opening-business-analyst-pharmaceutical-research-stratycon-freshers-eli#comments



14.03.2012 19:07:00

A medical doctor and former consultant to Takeda Pharmaceuticals is charging in a whistleblower lawsuit that the company failed to report serious adverse events related to the antidiabetes drug pioglitazone (marketed as Actos .

Helen Ge states in her lawsuit that Takeda “instructed medical reviewers not to report hundreds of non-hospitalized or non-fatal congestive heart failure cases as ‘serious’ adverse events and thus avoided its responsibility of accurately analyzing and reporting these hundreds of serious adverse events to the FDA [US Food and Drug Administration].”

She also claims that the company failed to report 28 of 100 cases of bladder cancers to the FDA, which she called a “serious discrepancy,” and that Takeda told her to change her notation that the cancers were “related” to “unrelated.” The suit says that she was fired after she complained to her supervisors about the company’s failure to report all serious adverse events.

The suit was originally filed in June 2010 but wasn’t publicly disclosed until 24 February, when the federal government declined to join the suit.

Dr Ge charges that Takeda “orchestrated” the downfall of its main competitor drug, rosiglitazone (GlaxoSmithKline’s Avandia , which is in the same class of drugs. In her suit she claims that after the
New England Journal of Medicine
published a study in 2007 (2007;356:2457-71 showing that rosiglitazone increased heart attacks and congestive heart failure, the FDA asked GlaxoSmithKline and Takeda in May 2007 to add warnings about heart failure for both drugs.

According to the suit, in November 2007 Takeda “began to run print advertising in 82 major market newspapers and national publications such as
Time
and
Newsweek
, advising readers with type 2 diabetes that ‘Actos has been shown to lower blood sugar without increasing your risk of a heart attack or stroke.’” At the same time Takeda stopped reporting non-fatal or non-hospitalised heart failure events as “serious,” while GSK continued to report all heart failure events as serious, unfairly positioning pioglitazone as safer than rosiglitazone.

Whether pioglitazone is actually safer than rosiglitazone is controversial. A 2010 meta-analysis by Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic in Cleveland, Ohio, reported that when compared with control treatment rosiglitazone increased heart attacks but not the rate of heart failure or cardiovascular mortality (
Archives of Internal Medicine
2010;170:1191-201, doi:
10.1001/archinternmed.2010.207 . David Graham, a safety officer with the FDA, conducted an observational, retrospective, inception cohort study of 227?571 patients aged more than 65 years to compare rosiglitazone and pioglitazone and reported that rosiglitazone was associated with “an increased risk of stroke, heart failure, and all-cause mortality and an increased risk of the composite of AMI [acute myocardial infarction], stroke, heart failure, or all-cause mortality” (
JAMA
2010;304:411-18, doi:
10.1001/jama.2010.920 . However, a retrospective cohort study published in 2010 in
Circulation
that assessed 36?628 patients taking either rosiglitazone or pioglitazone found no differences in overall heart failure, acute myocardial infarction and all cause mortality (2010;3:538-45, doi:
10.1161/CIRCOUTCOMES.109.911461 .

Dr Nissen told the
BMJ
that FDA statisticians “showed unequivocally that pioglitazone is less likely to cause ischaemic events than rosiglitazone.” He said, “These findings were confirmed by the analysis published in
JAMA
” and that “since several of these analyses” did not rely on data reported by Takeda “the differences are likely [to be] real.” He added that both drugs, however, “can precipitate congestive heart failure and cause fractures.”

France suspended pioglitazone in June 2011 over concerns about bladder cancer. Rosiglitazone is available in the United States with severe restrictions (
BMJ
2010;341:c5287, doi:
10.1136/bmj.c5287 , and the European Medicines Agency has suspended its marketing approval (
BMJ
2010;341:c5291, doi:
10.1136/bmj.c5291 .

Takeda said that it can’t comment on the allegations while the lawsuit is pending but that it “complies with all laws and regulations regarding the reporting of adverse events.” Dr Ge declined to comment.

Notes

Cite this as:
BMJ
2012;344:e2002

via
bmj.com

By Jeanne Lenzer

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15.03.2012 20:51:11
Location: NJ
Salary: 110000
Description: The position requires demonstrated expertise in general mammalian toxicology. The position will oversee the conduct of general toxicity and drug safety studies in accordance with current scientific and applicable regulatory standards (ICH, FDA and GLPs and will monitor safety studies related to drug registration. Preferably, the incumbent will be specialized in one or more of the following areas: general safety evaluation, genetic toxicology, safety pharmacology, reproductive toxicology, carcinogenicity evaluation. In addition, he/she is expected to provide technical leadership in non-clinical drug safety assessment in support of worldwide clinical and preclinical R&D. The incumbent will be required to make both informal and formal presentations to internal staff and project teams and may be asked to assist with presentations to senior management as well as providing project team representation and active involvement in process development. The incumbent will be expected to contribute to the preparation of relevant sections of drug registration submissions. Knowledge of the drug development process and experience in interaction with scientific disciplines such as pharmacokinetics, metabolism, medical research and clinical pharmacology are essential. A successful track record of toxicology testing program management, innovative thinking, execution and timely delivery of reports and regulatory submissions is helpful. PRINCIPAL ACCOUNTABILITIES: Direct responsibilities will include, but are not limited to the following: o Participation in the evaluation and qualification of CROs. o Assists in the design of study protocols for nonclinical toxicology and safety pharmacology studies for conduct at CROs. o Conduct, monitor, and manage toxicology studies at CROs. This will involve limited travel (~10% . o Reviews study data and reviews/revises final study reports for department authorization. o Assists in the preparation of the nonclinical safety sections of regulatory submissions for registration/marketing authorizations of new drug products o Provide technical expertise to support project teams goals and objectives. Educational Requirements A minimum MS in pharmacology, toxicology, biochemistry or related science is required. At least 5 - 7 years industry (preferably pharmaceutical experience with 3 + years' experience in the conduct of mammalian toxicology studies. Required Experience & Technical Requirements o Knowledge and expertise in toxicology and standard and alternative toxicology test methods is necessary to address the range of varied chemical substances that will need to be tested and to interpret and report the study results. o Knowledge of GLPs and direct experience in toxicology testing and/or study management is needed to successfully prepare protocols, implement, and adequately oversee the toxicity studies conducted by CROs and to understand the relative strengths and limitations of testing methods as they relate to hazard identification. o Knowledge and experience in internet/database searching is necessary to develop information that will allow the avoidance of duplicative and unwarranted use of animals in toxicology testing and to assure up-to-date and complete knowledge of available toxicology data and regulatory changes and initiatives. This includes but is not limited to experience in successfully searching FDA, EMEA, WHO, NTP, ASTDR, IARC, NLM databases. o Concise and accurate writing skills and clear and effective oral presentation skills.
Contact:
dld@judge.com
This job and many more are available through The Judge Group. Find us on the web at
www.judge.com




13.03.2012 4:48:00

MUMBAI: In a landmark decision that could set a precedent on how life-saving drugs under patents can be made affordable, the government has allowed a domestic company, Natco Pharma, to manufacture a copycat version of Bayer's patented anti-cancer drug, Nexavar, bringing down its price by 97%.

In the first-ever case of compulsory licencing approval, the Indian Patent Office on Monday cleared the application of Hyderabad's
Natco Pharma to sell generic drug Nexavar, used for renal and liver cancer, at Rs 8,880 (around $175 for a 120-capsule pack for a month's therapy.
Bayer offers it for over Rs 2.8 lakh (roughly $5,500 per 120 capsule. The order provides hope for patients who cannot afford these drugs.

The approval paves the way for the launch of Natco's drug in the market, a company official told TOI, adding that it will pay a 6% royalty on net sales every quarter to Bayer. The licence will be valid till such time the drug's patent is valid, i.e. 2020. As per the CL (compulsory licence order, Natco is also committed to donating free supplies of the medicines to 600 patients each year.

Bayer said it was "disappointed" and would "evaluate options to defend intellectual property rights" in the country. In July 2011, Natco had applied for the CL in the Mumbai patent office to make Sorafenib Tosylate for which Bayer has a patent in the country since 2008.

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15.03.2012 20:51:18
An excellent full time permanent opportunity has come up for either a Pharmacist or a Medical Information officer with a global pharmaceutical company based in Cambridge.

Responsibilities:

-Manage the collection, documentation and communication of all Pharmacovigilance / Drug Safety reports
-To contribute to the approval of promotional documentation produced in support of marketed products in accordance with the ABPI / PAGB Codes of Conduct
-Management of safety and other documentation ensuring that the documents are up to date, scientifically accurate and approved for the use in the UK
-Work closely with commercial department, including medical advisors, scientific advisors, sales and marketing
-Continue to provide up to date medical, technical and Pharmaceutical information on all of the companies' products to both internal and external customers.
-Regularly update all relevant information sources, including databases and factsheet
-Work with Medical Affairs to ensure the best possible outcomes from submissions
-Participate in promotional material screening



13.03.2012 5:05:00

Arrow Generics UK has launched generic versions of AstraZeneca’s Zomig (Zolmitriptan and Zomig Rapimelt (Zolmitriptan Orodispersible in the UK and France.

Arrow, part of the Watson Group, released the generics after the patent expired for the two treatments indicated for patients with migraine headache with or without aura.

Last year, the two treatments had sales in the UK and France of around $107 million in the two markets, according to IMS Health data.

The two generics are also set to be launched in the Nordic region later this month on the date of expiry.

Joining Zolmitriptan and Zolmitriptan Orodispersible, Arrow has also launched a generic alternative of GSK’s Naramig (Naratriptan – indicated for the same condition.

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15.03.2012 15:53:36

It's hard to know these days which way the proverbial worm is turning when it comes to shifts in drug policy. Election years tend to do that. Despite an historical turn of events in Central America which saw Presidents of drug trafficking nations come together to call for world wide decriminalization of drugs, in an effort to end the violence and corruption of the drug trade, the US continues to demur, absurdly claiming that the "War on Drugs" has been a success. Even stranger is Canada's recent announcement that they plan to follow the US model of a "tough on crime" approach to drug policy, which threatens to swell their correctional system in the same ways as in the US. Still, good news abounds with recent studies showing that LSD can cure alcoholism, psychedelics can cure PTSD, and cannabis smoking is not nearly as harmful as the prohibition governments claim. ~ CS 

Google+ Presents: 
It's Time To End The War On Drugs

To liberalise or prohibit, that is the question. And to answer it the masters of live debate have joined forces with the masters of web technology to create a never-seen-before combination of Oxford debating and Silicon Valley prowess.

Prohibitionists argue that legalising anything increases its consumption. The world has enough of a problem with legal drugs like alcohol and tobacco, so why add to the problem by legalising cannabis, cocaine and heroin? 



The liberalisers say prohibition doesn’t work. By declaring certain drugs illegal we haven’t reduced consumption or solved any problem. Instead we’ve created an epidemic of crime, illness, failed states and money laundering.

Julian Assange and Richard Branson; Russell Brand and Misha Glenny; Geoffrey Robertson and Eliot Spitzer. Experts, orators and celebrities who’ve made this their cause – come and see them lock horns in a new Intelligence?/Google+ debate format. Some of our speakers will be on stage in London, others beamed in from Mexico City or Sao Paulo or New Orleans, all thanks to the “Hangout” tool on Google+.

The web will have its say, and so can you at the event in London. Be part of the buzz of the audience, be part of an event beamed across the web to millions. Come and witness the future of the global mind-clash at the first of our Versus debates, live at Kings Place

Source:
Intelligence 2 from Google +

North America


America's plague of incarceration

The message is (or should be deeply disturbing. Shouldn't the USA be ashamed at having the world's largest prison system and highest incarceration rate (754 per 100 000 people ? The richest country in the world has so many of its citizens in prison that it can't afford to house them with even basic minimum medical care (more than half of all prisoners have mental health or drug problems . Prison overcrowding itself has become so terrible in California, that in May, 2011, the US Supreme Court affirmed a lower court order that California release some 46 000 prisoners because of the inhuman conditions under which they were being held. In the Court's words, “A prison that deprives prisoners of basic sustenance, including adequate medical care, is incompatible with the concept of human dignity and has no place in a civilised society.”

Source:
"
A Plague of Prisons: The Epidemiology of Mass Incarceration in America," 
The Lancet.


International Women's Day:  U.S. Must Address Impact of Mass Incarceration on Women.

More women are ending up behind bars than ever. Between 1980 and 1989, the number of women in U.S. prisons tripled. And the number of women in prison has continued to rise since. In the last 10 years, the number of women under jurisdiction of state or federal authorities 
increased 21 percent to almost 113,000. During the same time period, the increase in the number of men in prison was 6 percentage points lower, at about 15 percent. The increase in women in the federal population was even larger- over 41 percent from 2000 to 2010.

Most women are incarcerated for nonviolent offenses. Over one-fourth are in prison for a drug offense, while 29.6 percent were convicted of a property crime. Addiction plays a large part in a number of women's property crimes, and a lack of available or appropriate treatment only serves to drive their contact with the justice system.

Source:
Justice Policy Institute


From Cell to Screen: The Story of Mumia Abu-Jamal -- Part I


 

Stephen Vittoria is that rare commodity in Hollywood today: a filmmaker with a conscience. To be more precise, a filmmaker with a strong political conscience. After making two feature films,>Black and White& Hollywood Boulevard (1996 , as well as three feature documentaries:Save Your Life -- The Life and Holistic Times of Dr. Richard Schulze (1998 ,;Keeper of the Flame (2005 and the award-winning art house hit One Bright Shining Moment: The Forgotten Summer of George McGovern (2005 , a portrait of the South Dakota senator who tried to unseat Richard Nixon from the White House in 1972.

For his latest exploration into America's socio-political landscape, Vittoria joins forces with radio producer Noelle Hanrahan to bring Long Distance Revolutionary, the story of Mumia Abu-Jamal, to the screen. Born Wesley Cook in Philadelphia, Abu-Jamal made his name as a tireless writer and journalist during the racially-charged 1970s that often portrayed the City of Brotherly Love as anything but. With his intense coverage of the MOVE organization, a black empowerment group whose ongoing battle with the police and city hall came to a fiery end in 1985, Abu-Jamal become a constant thorn in the side of the city's powerful establishment. Things came to a sudden head for Abu-Jamal himself on the evening of December 9, 1981 when he was accused of murdering a Philadelphia police officer. He received a death sentence the following year, and has been on Pennsylvania's death row until early this year, when his death sentence was commuted to a life sentence in December, 2011.

Abu-Jamal's case remains one of the most controversial and heatedly debated in American legal history, with participants on both sides either protesting his innocence in the murder of Officer Daniel Faulkner or his absolute guilt with equal passion and more often, great vehemence.

Source:
Huffington Post


What’s In a Name? A Lot, When the Name is “Felon”

At a
recent conference of journalists at John Jay College, I raised an issue I have about language in the media:  the frequent use of the word “felon” to describe a person who has been convicted of a crime.

“Felon” is an ugly label that confirms the debased status that accompanies conviction. It identifies a person as belonging to a class outside many protections of the law, someone who can be freely discriminated against, someone who exists at the margins of society. 

In short, a “felon” is a legal outlaw and social outcast.  

Source:  
The Crime Report


Addiction: Medical Disease or Moral Defect?

Scientific theories that addiction hijacks the brain have just increased the stigma that they were meant to stop. At least in the moralistic bad old days, addicts were still viewed as having free will. Here's an alternative to both of these no-win approaches.

Source:
The Fix


Scientists Explore Hallucinogen Treatments for PTSD, Sex Abuse Victims

Mind-altering compounds, such as LSD and psilocybin, stirred controversy in the 1960s. As the counter-culture’s psychedelic drugs of choice, the widespread use - and abuse - of hallucinogens prompted tougher anti-drug laws.

That also led to a crackdown on clinical studies of the drugs’ complex psychological effects. However, now the U.S. Food and Drug Administration (FDA has begun to approve limited research into the potential benefits of psychedelic drugs.

No one is more aware of the stigma attached to psychedelics than Rick Doblin, director of the Multi-Disciplinary Association for Psychedelic Studies (MAPS , a drug development firm that funds FDA-approved clinical trials to examine the potential therapeutic uses of psychedelics.

Source: Voice of America

PBS Newshour: "Clearing the Smoke: The Benefits, Limits of Medical Marijuana"

Sixteen states have passed laws that allow patients to use medical marijuana to treat side effects of various illnesses, but now some are moving to either limit or repeal those laws. Anna Rau of Montana PBS reports.

Source: PBS Newshour

Drug users' union in San Francisco part of growing movement

Heroin shooters, speed users, pot smokers and even some men and women who now are drug-free convene regularly in this city's gritty Tenderloin district — not for treatment, but to discuss public health policy and share their experiences free from shame or blame.

Source: LA Times

New Report on Police Use of Force

How do varying policies affect police use of force? A new report, from research funded by the Department of Justice, examined eight police agencies, (Columbus, OH, Charlotte-Mecklenburg, NC, Portland, OR, Albuquerque, NM, Colorado Springs, CO, St. Petersburg, FL, Fort Wayne, IN, and Knoxville, TN and examined how different policies changed law enforcement strategies.

Researchers found that there is no ideal (or flawed policy approach across all outcomes, but the report offers ranking and outcomes for each policy offered allowing police executives to choose the best route for their force.

Access the report  here.

Source: The Crime Report

End 'destructive' war on pot, panel urges Harper

The Global Commission on Drug Policy says it's "very weird" that Canada is taking a tougher line on marijuana when governments across the globe are reconsidering the war on drugs.

In an open letter Wednesday to Prime Minister Stephen Harper, the Brazil-based commission calls on Canada to stop pursuing the "destructive, expensive and ineffective" prohibition of pot.

Louise Arbour, a former Supreme Court of Canada judge, former Brazilian president Fernando Cardoso, former Swiss president Ruth Dreifuss and Virgin Group founder Richard Branson are among the signatories to the letter that warns Canada is repeating "the same grave mistakes as other countries."

"Building more prisons, tried for decades in the United States under its failed war on drugs, only deepens the drug problem and does not reduce cannabis supply or rates of use," says the letter. "Instead, North American youth now report easier access to cannabis than to alcohol or tobacco."

Source: CBC

Marijuana Smokers Breathe Easy Says The University of Alabama

As of January 10, 2012, a new study has been published in the Journal of the American Medical Association exonerating marijuana from the bad reputation of being as harmful to your lungs when smoked as tobacco cigarettes. Researchers at the University of California San Francisco and the University of Alabama at Birmingham completed a twenty-year study between 1986 and 2006 on over 5,000 adults over the age of 21 in four American cities. Study co-author Dr. Stefan Kertesz is a professor of preventive medicine at the University of Alabama at Birmingham. He explained that the studies measured the pulmonary obstruction in individuals with up to seven joint-years of lifetime exposure (one joint per day for seven years or one joint per week for 49 years . "What this study clarifies," Kertesz explains in a released video, "is that the relationship to marijuana and lung function changes depending on how much a person has taken in over the course of a lifetime."

Source: Nugs.com

Marijuana Training Considered In Colorado Senate

DENVER (AP – Colorado senators have delayed action on a proposal to increase training for medical marijuana workers in Colorado. A Senate committee delayed a vote Wednesday on a bill setting up an optional “preferred vendor” classification for dispensaries and other companies that deal with medical marijuana. Under the proposal,the business community could decide to give all their employees additional training in exchange for a chance at softer penalties if they ever run afoul of state marijuana rules.

Source: CBS 4 Denver

Europe

Greek Health Crusader Is Arrested For Ordering Hemp Protein

Athens, Greece — On Wednesday morning July 16th, Anna Korakaki went to her local post office in Athens, Greece to pick up her latest health product order from Navitas Naturals, a health food company based in the USA. Anna had previously received shipments from Navitas which included raw cacao and maca from Peru, goji berries from China, and other high-quality nutritious foods. Moments after accepting her package Anna was immediately intercepted by 4 police officers, thrown on the hood of a police car and brutally handcuffed. Police then ransacked her apartment and after finding nothing suspicious or illegal, took Anna to a police station for further interrogation. Anna was then forced to spend the night in an Athens jail cell. The reason for Anna Korakaki's arrest was that she had received 4.5 kilos of hemp protein (a 'super-food' made from powdered hemp seeds , which she had ordered for the express purpose of making healthy smoothies. The order had a value of 57 Euros (US$89 , and represented but one of hundreds of hemp products available worldwide in health food stores, super-markets and via the Internet.

Source: Hemp Industries Association

LSD 'helps alcoholics to give up drinking"

A study, presented in the Journal of Psychopharmacology, Helmet, Freesans looked at data from six trials and more than 500 patients. It said there was a "significant beneficial effect" on alcohol abuse, which lasted several months after the drug was taken.

An expert said this was "as good as anything we've got".

LSD is a class A drug in the UK and is one of the most powerful hallucinogens ever identified. It appears to work by blocking a chemical in the brain, serotonin, which controls functions including perception, behaviour, hunger and mood.

Source:  BBC

Having trouble with drinking? Maybe you should try a dose of Acid. Researchers claim that a single dose of LSD could be helpful in treating alcoholism. A new paper, published in the  Journal of Psychopharmacology , examines six different trials throughout the '60s and '70s, involving a total of 536 patients being treated for alcohol problems. The researchers, from the Norwegian University of Science and Technology's department of neuroscience, discovered that 59% of subjects given a single dose of LSD showed improvements in their alcohol habits in follow-up assessments months later—compared with just 38% of people who didn't take the drug.

Source: The Fix

Source: The Journal of Psychopharmacology: "Lysergic acid diethylamide (LSD for alcoholism: meta-analysis of randomized controlled trials."

Latin America

Legalization Debate Takes Off in Latin America

Something incredible is happening right now in Latin America.

After decades of being brutalized by the U.S. government's failed prohibitionist drug policies, Latin American leaders, including not just distinguished former presidents but also current presidents, are saying "enough is enough." They're demanding that the range of policy options be expanded to include alternatives that help reduce the crime, violence and corruption in their own countries -- and insisting that decriminalization and legal regulation of currently illicit drug markets be considered.

Source: Ethan Nadelmann, Huffington Post

Is Latin America heading towards drug legalization?

On Saturday February 11, Guatemalan President Otto Perez Molina declared that following discussions with Colombian President Santos, he will present a proposal for the legalization of drugs in Central America at the Summit of the Americas, on April 14-15. Guatemalan Vice-President Roxana Baldetti toured Central America to discuss the proposal with regional leaders and garner support for it, starting with Panama on February 29. Unsurprisingly, the move was greeted by a quick rebuke from the US government who hurriedly dispatched Secretary of Homeland Security Janet Napolitano to the region on February 28, one day ahead of Roxana Baldetti’s own tour. Baldetti still managed to gain the support of Costa Rica and Salvador. The US is now pulling out its heavy artillery, sending to the region VP Biden, a staunch supporter of the War on Drugs.

Source: World War-D

Honduras Invites Colombia and Mexico to Join Drug Legalization Debate

President Porfirio Lobo yesterday invited Colombian President Juan Manuel Santos and Mexican President Felipe Calderon to a meeting of the presidents of Central American Integration System (SICA on March 24 in Guatemala. The gathering will focus on a recent proposal by Guatemalan President Otto Perez Molina to legalize drugs. On Tuesday, presidents met in Honduras with United States Vice-President Joe Biden to discuss the issue of drug legalization as strategy for combating the growing power of organized crime in Central America and Mexico and the associated violence plaguing the region. Despite Vice-President Biden's reiteration that the US government is adamantly opposed to legalizing drugs, there appears to be enough support for the idea among SICA heads of state to continue the debate and expand it to other nations such as Mexico and Colombia, which have also been affected by transnational narcotrafficking.

Source: Honduras Weekly

New Exile Nation Video

JULIE FALCO & DAN LINN

Julie Falco and Dan Linn are two of the leading drug policy reform activists in the State of Illinois. They have spent the better part of the last 10 years attempting to pass a medical cannabis bill, and have found themselves consistently thwarted.

Julie has advanced Multiple Sclerosis and is confined to a wheelchair. When she discovered edible cannabis as a medicinal therapy for MS patients it changed her life, and so she dedicated herself to bringing this medicine to others. But it was only after the death, in police custody, of a quadriplegic named Johnathan Magbie, that she found her strength to speak out.

Dan Linn began his activist work as a college student, and has since grown into a formidable voice for reform, appearing on television and in the news debating with career drug warriors.

Weekly Newsletters & Digests

Drug War Chronicle #725 - March 15, 2012

UK Drug Policy Commission - New Reports Online

editors
15.03.2012 22:02:00
Teva Pharmaceutical Industries Ltd. Has won U.S. approval to sell the first generic version of Lexapro for depression and anxiety. Teva has been granted a 180-day exclusivity, so no other firm can market the generic medication in the United States in that timeframe, the Food and Drug Administration (FDA said in a news release.
http://www.news-medical.net/news/20120315/Teva-gets-exclusive-180-days-to-market-generic-antidepressant-and-anti-anxiety-pill-Lexapro.aspx#comment
15.03.2012 18:51:21

On March 6, 2012, the Food and Drug Administration (FDA approved Surfaxin to treat respiratory distress syndrome (RDS . RDS is a potentially dangerous condition that occurs when an infant is incapable of naturally producing pulmonary surfactant, a liquid coating inside the lungs that helps to keep them open. Premature infants may show signs of RDS at birth or within the first few hours after delivery.

Biopharmaceutical company Discovery Laboratories Inc. develops surfactant technology for surfactant replacement therapies (SRT to treat various respiratory diseases. The company filed for a new drug application in 2004. Since then, Discovery Laboratories has been denied marketing permission four times. In 2005, an “approvable letter” was sent stating that the new drug application will be reviewed and included specific terms and conditions that must be met prior to gaining U.S. marketing permission. 

In 2009, the FDA asked Discovery to validate a biological activity test (BAT to ensure Surfaxin’s quality and stability.  A number of meetings were scheduled with Discovery to discuss details of the BAT and to establish a plan for moving forward before Surfaxin could be commercially marketed in the United States.

Last month, an Advisory Panel for the FDA recommended that Surfaxin be approved. Surfaxin is the fifth drug to be approved in the U.S. for RDS treatment. It is the first synthetic peptide containing surfactant to be approved for commercial use in neonatal medicine. It is estimated that 90,000 premature infants receive animal deprived surfactant treatments each year in the U.S. 

Moving forward

Discovery Laboratories states that commercial marketing of Surfaxin will take place later this year. The company anticipates sales to range between $50 million and $75 million. It also plans to conduct clinical programs for acute respiratory distress syndrome (ARDS in adults, neonatal respiratory disorders (NRD in infants, severe asthma in adults, and other respiratory diseases.

 
Tags: 
http://consumer-drug-report.com/content/fda-finally-approves-surfaxin#comments
14.03.2012 0:46:52
Greg Jericho

If there is one buzzword of economic policy this year it is productivity.

Want to be a politician, policy wonk or media commentator and you want to deliver or analyse economic policy? Make sure you throw in a good helping of "productivity".

It has quickly become the tomato sauce of policy - put it on top of everything in the belief that it makes everything taste a bit better or at least takes away the flavour of the bad policy underneath.

In the past week Wayne Swan, Tony Abbott, Joe Hockey, Secretary of the Treasury Martin Parkinson, and Reserve Bank Governor Glenn Stevens have all either made speeches mentioning productivity, or - in the case of Stevens - including mention of it in his statement announcing the cash rate.

Actually concern about productivity is no recent phenomenon. It has long been regarded as the key to economic growth and improvement in standard of living. And if there is one rule about discussing productivity it is that at some point you quote Nobel Prize-winning economist Paul Krugman who wrote back in the 1990s:

Productivity isn't everything, but in the long run it is almost everything. A country's ability to improve its standard of living over time depends almost entirely on its ability to raise its output per worker.

So it seems pretty important then. So important that it probably deserves to be treated with a bit more respect than it currently is by many in politics, business and the media - where it is now so widely used that quite often it becomes divorced from its actual meaning and refers to whatever the speaker or writer wants it to mean.

Aside from the great words of Professor Krugman, why is productivity such a concern? The main reason is the graph below. Productivity is generally (and very roughly defined as GDP per hour of work. Given that as a rule the national productivity increases over time, we care less about the actual amount of "GDP per hour worked" and more about the level of growth of GDP per hour worked. As you can see the graph below shows this growth in productivity has been declining since around 2000.

Now if quoting Paul Krugman is the first rule of discussing productivity, the second rule seems to be to ignore that he says "it isn't everything" and to assume he meant "it is everything". The next step is to confuse productivity with labour participation and output.

To explain, take this example:

Imagine if you work at a pie-making factory with five workers that produces 500 pies a day (or 100 per worker, or 12.5 pies per hour . Then one day your boss comes and says the company is hiring two young people and two seniors and that this will improve productivity. If your boss did say that what she/he would in effect be saying is she/he is hiring two young people and two seniors who will be able to produce more pies per hour than what you and the rest of your co-workers can produce. Remember productivity is output per hour worked. So if these new employees actually were slower at their job than you and your co-workers then productivity would actually decline. Let's say these new workers only can produce 10 pies an hour. They combined would make 320 pies a day. The original five workers churn out their usual 500, meaning the company now makes 820 pies a day, but the average pies per worker per hour is now 11.4 pies per hour.

Labour participation has increased (four new workers ; output has increased (320 more pies , but productivity has decreased.

Now is that a bad thing? Not for the four new workers - they have a job, and it may not be bad for the company - especially if can sell the extra 320 pies. But if it wants to make the same profit per pie it will actually have to increase the price it sells them for. So it might end up bad for those who buy the pies, because now they have to pay more for them.

I use this example because last year Tony Abbott announced a productivity policy:

Over the past two years, GDP per hour worked has not grown at all. To improve productivity, the Coalition will provide incentive payments to employers who take young people and seniors off welfare into work.

Now that policy might increase national labour participation, it might increase national output (GDP , but will it "improve productivity"? In the short term, almost certainly not - the new workers will have to be trained and while they are being trained their productivity will be lower than the other workers, thus productivity will decline. In the medium to long term it is also unclear how productivity will increase unless for some reason these new workers are trained better than the current workers and thus become more productive than the current workers.

Joe Hockey committed the same error last week in his speech to the Sydney Business Chamber in which he promised that that the Liberal Party would offer "a souped up productivity agenda". He stated:

The sad truth is that productivity growth has stalled under this Government. GDP per hour worked fell over the 18 months to September quarter 2011 [11]. Australia has been producing less for a given effort.

The Coalition has a compelling strategy to help lift productivity.

First will be genuine welfare reform to lift participation in work since there is no-one so unproductive as the person who is able to work but is not doing so.

Well if by a "compelling strategy" he means one that may increase participation but is pretty much guaranteed to reduce productivity in the short term, then yes, it is. Hockey's statement about "there is no-one so unproductive as the person who is able to work but is not doing so" sounds quite reasonable and logical at first blush.

The only problem is it has nothing to do with the problem of productivity that he states in the first part when he talks of "stalled productivity growth".

To go back to the example of the pie factory, Hockey is suggesting productivity has increased because at first there were nine people making 500 pies (but four were unemployed , and after the four new people were hired the nine people were making 820 pies. Huzzah! Productivity increase!

Except we don't measure productivity that way, because we already have a category that measures output per person - it's GDP per capita. We also already have a category to measure the rate of participation in the workforce. It's called, funnily enough, the "participation rate". Here's a look at how it has been doing since 1978 (the same period as the productivity growth graph above :

The rate has been climbing the whole time and exploded in the 1980s from 1983 to 1990, and again from 2004 to 2009. In the 1980s this was due to a big surge in women entering the workforce. In February 1983 only 44.5 per cent of Australian women were either working or looking for work; by 1990 it had increased to 52 per cent. The participation burst from 2003 to 2009 was due to an increase in the participation of both men and women.

But if you look at the participation rate and the productivity rate graphs when participation was increasing in the late 1980s, productivity growth was declining – and a similar thing happened during the 2003-2009 participation burst. There was an increase in both productivity growth and participation in the mid 1990s, though you would be hard pressed to suggest a correlation. The best you can argue is that increased participation increases productivity in the mid-long term.

What it shows is that to increase productivity you need to do more than just get people into the workforce.

A similar error occurs when talking of paid parental leave. The Liberal Party's proposed plan is frequently linked in the media with productivity.

Except when the Productivity Commission looked at Paid Parental Leave back in 2009, the one aspect it was very hedgy on was the gain in productivity. In fact it found that for many companies productivity would decline because during the parental leave a temporary worker would need to be brought in, who would most likely be less productive than the person on leave. One area it suggested there may be productivity increase in the long term is for the children of those parents who are able to take the leave, because of the positive effects of parent-child bonding in those first six months.

When the Productivity Commission talked of productivity benefits of parental leave for companies it mainly discussed for individual companies that offered such leave compared to those who don't - as the companies that do offer it are more likely to attract higher skilled women. But such benefits are largely removed if all companies have to have in place a paid parental leave scheme.

Now this is not to suggest that a parental leave scheme or encouraging young people and older workers on welfare back to work is a bad thing. Far from it - they are actually excellent policy aims, but not because of increases in productivity - but rather because they will increase participation and output. But it goes to the mistake of politicians, business leaders (and often journalists believing that productivity is everything. In the House of Representatives Committee Inquiry into raising the level of productivity growth in the Australian Economy in 2010 the Department of Treasury nicely explained this fallacy:

Some people who are not currently in the labour force, if you brought them into the labour force, may be less productive than the current average worker. So, if you took a strict measure, you could say they may reduce labour productivity through reducing the average. That might be a nice technical point but it would be a pretty silly conclusion. Given that there are a range of disincentives for participation, removing those and improving overall workforce participation outcomes clearly enhances wellbeing overall.

Thus productivity is not everything - wellbeing is. We want people to come into the workforce (and stay - in the case of parents because young people who get into the workforce are more likely to have a higher lifetime income than those who stay on welfare longer into their 20s, the same goes for families where both parents are able to work. Policies that increase participation and output are worthy enough goals by themselves and certainly do not need to be justified on productivity terms.

Paul Krugman himself noted the problems of being concerned too greatly with productivity when he wrote last year of Ireland, which had apparently seen an increase in competitiveness since its "austerity measures" were introduced after the GFC. He noted:

… what has happened in the austerity era is that sectors, which aren't selling to the domestic market, have held up much better than labour-intensive sectors serving that domestic market. And this causes a spurious increase in labour productivity: if you lay off a construction worker but don't lay off a pharmaceutical worker who basically watches over very expensive machines that produce a lot of output, it looks as if productivity has gone up, but in any individual sector nothing has happened.

This is what happens when we get into trouble if governments and businesses focus purely on productivity and forget that there is no point increasing productivity if it means less people are working.

The other rule of talking about productivity is that it must involve Industrial Relations - and usually assertions that unions are killing productivity. For example BHP Chairman Don Argus in a speech last month stated:

I believe we have seen a major warning light for productivity in the disruption many businesses face from strikes and the rising power of unions.

We see this link often mentioned - especially in The Australian and the Australian Financial Review, which both push pro "flexible labour market" policies.

Last week the Australian Bureau of Statistic released its quarterly " Industrial Disputes" figures. It showed that while work days lost due to strikes had declined in the last quarter, they had risen in the 2011 compared to 2010. The Australian reported it as:

The number of days lost to strikes and lockouts has almost doubled in the past 12 months, in a further brake on the nation's productivity.

What the article didn't say was that while the number of days lost had almost doubled in the past 12 months, so too had productivity:

In 2010, productivity actually declined but number of hours lost due to strikes was also down. In 2011 both productivity and the number of working days lost increased.

This is actually not a unique occurrence. A comparison of productivity and working days lost over the past 20 years shows the same thing:

In the past 20 years the days lost to strikes has dramatically decreased - from an average of 164 days lost per quarter from 1991-2001 to 55 days lost per quarter from 2001-2011. And yet in the 1991-2001 period, the average quarterly productivity growth was 0.6 per cent, compared to 0.2 per cent in the past 10 years.

I don't mean to suggest more strikes leads to more productivity, but to show that linking strikes to declines in productivity is easily done unless you want to find some actual proof, because the data does not show that more strikes leads to a "brake" on productivity. What they may lead to is less output, but that is a very different aspect to productivity. Thus declining productivity growth may be a tad more complex problem than simplistically being the fault of unions or IR policy.

If we are going to talk about productivity (and Australia's problems with it the best thing politicians, business leaders and the media can do is not to suggest productivity is everything, nor to suggest everything should be done or should not be done because of productivity. Similarly realising that productivity is not participation nor output might also help voters so that when we next hear politicians brag about how they will increase productivity we will know if they are producing good policy, or are just increasing the output of bulldust.

Greg Jericho is an amateur blogger who spends too much of his spare time writing about politics. His blog can be found here. View his full profile here.

13.03.2012 5:37:00

Johnson & Johnson (JNJ faces a U.S. government demand to raise its offer by $800 million from an initial proposal to settle a federal civil investigation into marketing of the antipsychotic Risperdal, according to three people familiar with the matter.

The Justice Department is demanding that J&J pay about $1.8 billion to resolve the civil claims by the U.S. and some states, the people said. The company raised its offer to settle the civil investigation to $1.3 billion by March 8, and negotiations on a final amount are continuing, one person said.

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14.03.2012 18:00:00
Health Network Communications recently interviewed Stefanie Thomas, Drug Assessment, IQWiG on what she thought the top issues impacting pharmaceutical market access were, and how she addressed these issues...
15.03.2012 23:41:00

It is absolutely unacceptable that this industry pushes people to believe that medicine is expensive because research and development is costly. These companies sweep negative clinical trial findings under the rug, invest in developing drugs that may be less effective and more dangerous than ones already on the market and care more about improving a patient’s self-esteem than saving lives.

By Rebecca McGoldrick

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14.03.2012 21:00:00
marcus evans, a conference producing company, will host the 2nd Global Pharmacovigilance & Adverse Event Reporting Conference, May 22-24, 2012 in Boston, MA. More than 16 leading experts will provide insights on dissecting the impact of new global regulations, understanding adverse reporting requirements, strengthening data mining and REMS and deploying signal detection tactics...
15.03.2012 20:51:18
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