98 New Drug Inspectors to be recruited in Tamilnadu

As part of strengthening the department of drugs control for better enforcement of drug acts, the government of Tamil Nadu has decided to fill up vacancies of 98 drug inspectors against a sanctioned strength of 146 posts.

The state public service commission has called for applications from graduates in pharmacy for written test and interview and the process will be completed by June this year, it is learnt.

Along with the recruitment of new drug inspectors, the government will also fill up 23 vacancies of junior analysts in the state drug testing laboratory, for that too, the PSC has invited applications. Graduates with B Pharm or B Sc qualifications can apply for the posts.

The last time recruitment of drug inspectors in the department was taken place in January 2010, when 23 vacancies were filled up. It was after a period of ten years that appointments were held, still vacancies were existing. At present the Tamil Nadu drugs control department has only 48 drug inspectors for inspection and sample collections in the hospital pharmacies, retail and wholesale shops and manufacturing companies covering 32 revenue districts.

Currently, due to shortage of staff, the workload on the drug inspectors is quite heavy affecting the work efficiency. As per rules one inspector has to inspect 50 retail outlets and an equal number of wholesale stores in a month and should collect seven samples for testing. In most of the months the routine work cannot be completely fulfilled with the limited staff. Since the majority of drug inspectors are females and working in villages, they cannot fulfill the target always.

As far as the drug testing laboratory is concerned, due to lack of technical staff and analysts the test reports are always delayed. So the drug inspectors are collecting samples of long expiry drugs. If short expiry samples are taken and found in the lab test as ‘not of standard quality’, the department will not get sufficient time to hold investigation and further action. So, all the drug inspectors are collecting long expiry samples, sources from the traders’ community maintained.

To solve all these problems, the present drug controller has submitted a project, including new recruitment, to the government which later approved it. The drug inspectors complain that inadequacy of conveyance facility is becoming a major challenge to their work.

Source: Pharmabiz

Fancy stat!

I was taking a quick look at my blog status and a fancy stat figure brought in a smile in my face and could not resist sharing with the readers (without whom this wouldn't have become possible)

Thanks for visiting my blog & subscribing for feeds. Will continue to feed you with useful news & analysis.

Hats On For Skin Health

Hats On For Skin Health is a global campaign to spotlight the deadly effects that sun rays can have on the sensitive skin of albinos. Through a worldwide effort, the program aims to raise funds to purchase hats and other sun-protective items for albinos living in Tanzania, a country in East Africa with one of the highest rates of albinism in the world.

Albinism is a genetic condition passed from parent to child, in which the body does not produce the pigment melanin. Albinos are born with pale skin, light hair, pinkish eyes and impaired vision. Melanin is the skin’s own natural protection against the sun’s rays – and lack of melanin puts albinos at risk for many types of solar skin damage, including deadly skin cancers. Worldwide, albinism affects about one in 20,000 people. However, the incidence of albinism in sub-Saharan Africa is significantly higher than in the rest of the world, and Tanzania has one of the highest rates of all with an incidence of one in 1,429, or approximately 30,000 people.

The risk is of skin cancer is especially great for albinos living in sub-Sarahan Africa, where ultraviolet rays are high because of the close proximity to the Equator.

Stiefel, a GSK company have announced today that Hats On For Skin Health, their global campaign with the International League of Dermatological Societies (ILDS), have raised enough funds to produce 15,000 sun-protective hats for albinos living in East Africa and has already distributed more than 2,000 hats.

In addition to support from ILDS, the American Academy of Dermatology (AAD) has assisted the Hats On For Skin Health campaign by making information about the campaign available on its website, and by accepting donations in the United States for the campaign.

Source: PRNewswire

First generic Lexapro to treat depression and anxiety disorder

On March 14, 2012, the U.S. Food and Drug Administration approved the first generic Lexapro (escitalopram tablets) to treat both depression and generalized anxiety disorder in adults.

Depression is characterized by symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of depression often recur throughout a person's lifetime.

Signs and symptoms of major depression include: depressed mood, loss of interest in usual activities, significant change in weight or appetite, insomnia or excessive sleeping (hypersomnia), restlessness/pacing (psychomotor agitation), increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicide attempts or thoughts of suicide.

People with generalized anxiety disorder (GAD) are filled with exaggerated worry and tension, even though there is little or nothing to provoke it. They anticipate disaster and are overly concerned about health issues, money, family problems, or difficulties at work. GAD is diagnosed when a person worries excessively about a variety of everyday problems for at least six months. People with GAD can’t relax, startle easily, and have difficulty concentrating.

Source: FDA

FDA Guidance Documents Update

The US FDA have released the following guidance documents recently.


1. Guidance for Sponsors, Investigators, and Institutional Review Boards: Questions and Answers on Informed Consent Elements,21 CFR § 50.25(c) (Small Entity Compliance Guide)

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM291085.pdf

2. Guidance for IRBs,Clinical Investigators,and Sponsors: IRB Continuing Review After Clinical Investigation Approval

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294558.pdf

3. Guidance for Industry and FDA Staff: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND, Frequently Asked Questions

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294729.pdf

4. Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers, Final Guidance

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM295372.pdf

Interview With Pfizer Director on Virtual Clinical Trials

Found an interview of Pfizer Director, regarding virtual clinical trials.

Virtual Trials - Still REMOTE ?

Just as I wrote about virtual trials (interestingly came to know about it around the "Partnership in Clinical Trials" conference where there was a session on this topic), there was an update on this topic supporting my initial apprehensions of the practicality of this fascinating approach. 

Miguel Orri, Senior Director of clinical sciences at Pfizer, at the ‘Partnerships in Clinical Trials’ conference, have indicated that the virtual trial "REMOTE" did not recruit.

Reasons:

• It did not ‘appreciate what patients need’ - Patients don’t want to divulge their medical information online, or to a pharma company.
• Another problem is that many patients affected by overactive bladder disorder are elderly, and do not use the internet as regularly as younger patients. (I've seen many granny's are on FaceBook these days.. shouldn't be a problem in the near future)
• Importantly, the aspects of the process were ‘quite complicated and tedious

Plan of Action from Pfizer:

Pfizer is collecting feedback from participants in the US trial to improvise the model. They have also now taken steps to revamp the model by creating a new call centre to helps patients through the initial steps. 

This bitter start in US should help them with their European virtual trial, dubbed REMOTE 2.0. Pfizer said they would contract a recruitment vendor to help patients through the initial setup process, making it easier for patients. All participants in the European trial will also receive a communication device to help with updating their e-diaries.

source: InPharm

Previous Articles:
Virtual Clinical Trials - Pfizer leads the race

Virtual Clinical Trials - Pfizer leads the race

I was very much interested to know what this is all about when I saw the Program of "Partnerships in clinical trials" conference that started yesterday at The Marriot World Cener, Orlando, FL, USA. Really interesting idea.

How about running clinical trials at a subject's home ?! Yes, that is all about Virtual Clinical Trials.

Pfizer have become the forerunner of this new approach in clinical trials. They have decided to leverage the advantages that the digital world provides to overcome the difficulties faced while conducting a usual clinical trial. Difficulties range from finance, logistics, partnering, enrolling patients, labs, ethical and legal issues, storage, dispensing of IP, etc. in a clinical trial. If not all the difficulties, many of those seems to be overcome in virtualtrials (which has limitations of its own!)

Pfizer began the first ever virtual clinical trial, REMOTE (Research on Electronic Monitoring of OAB Treatment Experience) to determine whether the results of the pilot ‘virtual trial’ can replicate those of a previously completed Phase IV study with tolterodine tartrate (Detrol LA)

• 600 patients from around 10 states across the US
• Screening is online
• Consent online using video/multimedia
• Subjects will manage their own trial activity and report results directly to a trial investigator,
• Study drugs will be shipped to the subjects' homes rather than to study sites
• Study participants will get $25 for each online assessment and/or laboratory visit completed, up to a total of US$175.
• No study site visits

Potential advantages would be real time and reliable data collection, a lot of time, money and effort saved. A lot of paperwork is eliminated and of course audit findings will be clear.

“Studies like REMOTE could make biomedical science much more accessible to people who have long been excluded from or under-represented in clinical trials,” said Dr Freda Lewis-Hall, executive vice president and Chief Medical Officer of Pfizer.

But to train almost 600 people on the systems to use, procedures to follow will be tough job for Pfizer and the advent of technology is itself a limitation of its use. And the main disadvantage of this would be that this system is more applicable to conditions where there are a lot of patient reported outcomes and those that does not involve any complex diagnostic or treatment procedures. That again raises a concern of the scalability of this system. Moreover, I cannot imagine something like this to be a reality (at least in half a decade) in an African country or a developing nation where the cost of healthcare is still a economical burden on the patients.

Least, this does spice up the clinical trial experience for trial personnel and subjects who are tech savvy!

Here is the program at "Partnerships in Clinical Trials" confernence. No wonder Pfizer dominates this  session. They lead the race with no visible competitors.

Monday, March 5, 2012—Executive Summit Day and General Session Kick-Off 9:30 Chairperson's Opening Remarks,PFIZER INC. 9:45 Virtual Trials— what are They? - PFIZER INC. 1030 Making a Study Different: What is Truly Innovative About the Virtual Trial Approach? - GENENTECH (ROCHE) 11:00 Break 11:30 Case Study: New Results From Pfizer's Mobile- Powered Virtual Clinical Trial Outsourcing Pilot Program, PFIZER INC. 12:30 Lunch 1:30 Assess the Legal Risks and Considerations of Virtual Trials, GORDON & REES LLP. 2:15 Examine Collaboration of Technology Companies Needed to Support the Virtual Trial Model 2:45 Industry Collaboration: How Should We Approach and Work With the FDA to Create a Regulatory Process for Virtual Trials? - PFIZER INC. AND JANSSEN 3:30 Summits End

WHO updates guidance for joint prevention, diagnosis and treatment of TB and HIV

Global health impact reported that an estimated 910 000 lives were saved globally over six years by improving collaboration between TB and HIV services that protect people living with HIV from TB. 

In 2004, WHO proposed the initial guidance on collaboration between TB and HIV activities and there was a 12-fold increase in the number of HIV people screened for TB. The number of HIV people screened for TB in 2010 was over 2.3 million. On the other hand, number of TB people screened for HIV rose from approximately half a million in 2005 to 2.2 million in 2010, a five fold increase!

These success stories have triggered WHO to release an updated global policy for joint prevention, diagnosis and treatment of TB and HIV. 

Since HIV being a disease of the immune system, people with HIV are much more likely to be infected with a variety of other diseases like HCV and TB.

The new policy calls for routine HIV testing for TB patients, people with symptoms of TB, and their partners or family members; provision of co-trimoxazole, a cost-effective medicine to prevent against lung or other infections for all TB patients who are infected with HIV; starting all TB patients with HIV on antiretroviral therapy (ART) as soon as possible (and within the first 2 weeks of starting anti-TB treatment) regardless of immune system measurements; evidence based methods to prevent the acquisition of HIV for TB patients, their families and communities.

More than 100 countries are now testing more than half of their TB patients for HIV. Progress was especially noteworthy in Africa where the number of countries testing more than half their TB patients for HIV rose from five in 2005 to 31 in 2010.

Click here to read the entire 36 pages policy document 

The new WHO Policy for joint prevention, diagnosis and treatment of TB and HIV will be presented in detail on 5 March at the annual Conference on Retroviruses and Opportunistic Infections (CROI), in Seattle, Washington.

Source: WHO

Conference on Retroviruses and Opportunistic Infections (CROI) 2012

CROI 2012 will take place from March 5-8, 2012 at the Washington State Convention Center in Seattle, Washington.

The Conference on Retroviruses and Opportunistic Infections (CROI) is a scientifically focused meeting of the world’s leading researchers working to understand, prevent, and treat HIV/AIDS and its complications. The goal of CROI is to provide a forum for translating laboratory and clinical research into progress against the AIDS epidemic. Over 4,000 leading researchers and clinicians from around the world convene in a different location each year for the Conference.

Registrations will close on Wednesday, February 8. Few days more. Hurry up!!

Click here for Program at-a-Glance

If you may not be able to attend the meeting, never mind. 90% of the meeting will be available online (including program, abstracts, electronic posters as well as webcasts of plenaries, symposia, scientific overviews, oral abstract sessions, and themed discussions). Webcasts are also available as streaming video on the Apple iPad and iPhone.