AIDCOC to approach UPSC to include pharmaceutical science in optional subject list of civil services exams

The All India Drug Control Officers’ Confederation (AIDCOC) will soon approach the Union Public Service Commission (UPSC) demanding to include pharmaceutical science in the optional subject list of UPSC’s civil services examinations.

AIDCOC, in association with the Delhi unit of Indian Pharmacy Graduates' Association, will soon submit the memorandum to the UPSC after mobilizing support from Pharmacy Council of India (PCI) and associations of pharmacy professionals and students, said Ravi Uday Bhaskar, secretary general of AIDCOC.

He said the association will send circulars in this regard to all the pharmacy colleges in India, students’ organizations, teachers associations and to the associations of college managements. Support of the leaders of pharma industry will also be sought.

Pharmaceutical science is a professional subject like medicine, engineering and architecture. Apart from other basic subjects, agriculture, veterinary, engineering and medicine are included in the curriculum of civil services examination, but pharmaceutical science is not included. It is, in fact, a kind of discrimination towards this noble profession and the subject, he said.

Atul Kumar Nasa, president of IPGA Delhi, said since pharmacy profession is a technical profession, a copy of the memorandum will be forwarded to All India Council of Technical Education (AICTE) for support. He said pharmaceutical science, unlike other subjects, is a subject directly related to the health and welfare of the public, and pharmacists have become an integral and inseparable component of the Indian society. So, the opportunities to serve the community with administrative power should not be shunned in the case of pharmacy professionals.

M Dilip Kumar, Tamil Nadu state secretary of the Confederation while speaking to Pharmabiz said the pharmacists in India have been making this demand for the last 15 years to UPSC, but the efforts bore no fruit. He said if this subject is included in the list, the pharmacy professionals will get a chance to enter into the administrative side serving in various civil services positions.

Gujarat FDCA selects 32 drug inspectors, total rises to 100

The Gujarat State Food and Drugs Control Administration (FDCA) recently selected 32 drug inspectors from the state to fill up the increasing demand for drug officers. The latest recruitment was for position of class II level drug inspectors  who have cleared the Gujarat Public Service Examination (PSE) that was held recently in the state.

With this the total number of drug inspectors in the state of Gujarat has risen to almost 100. According to Dr H G Koshia, commissioner, Gujarat FDCA, “We have always made it a point to ensure that we are adequately staffed with qualified officials to handle the increasing workload. This has helped us to achieve    the status of being one of the best state drug authorities in the country.”

As of now there are almost 100 drug inspectors in the state apart from the 50 senior drug inspectors. Dr Koshia informed that Gujarat is the only state in the country to have the post of senior drug inspectors. Giving statistics he explained that the state of Gujarat has 27 assistant commissioners out of which two sits with him in his office at Gandhinagar, 26 district commissioners, 6 deputy commissioners, and five joint commissioners who help him in conducting various drug related activities in the state.

He said, “For us the most important priority is to ensure that all our offices are equipped with the best services available which includes adequate competent staff. This is because it will help us in restoring efficient enforcement of regulatory works like inspections in manufacturing sites and pharmacies etc in a more organised and effective manner.”

The recruitment of the new drug inspectors comes at the right time as the state will soon require assistance of additional officers to fill up the demands coming out of the slew of activities being witnessed in the state.

Most of the state drugs authorities in the country are understaffed because of the shortage of qualified and trained manpower in the country. Gujarat FDCA is one of the few food and drug control administrations in the country to have taken steps to address this issue

Hyderabad,Visakhapatnam emerging as major centres of medical tourism in India

Over the past few years Hyderabad has become the hub of medical tourism in India. As the government is also encouraging the concept, it is growing day by day with more tourists coming to the city. Grabbing it right, the corporate hospitals are making the maximum out of the opportunity. They are introducing new methods of treatment and innovative medical techniques to attract more patients from abroad. Most of the medical tourists are attracted to the traditional treatments offered by the hospitals.

Along with Hyderabad, the city of Visakhapatnam is also following the suit. Both the cities in Andhra Pradesh are known for their super speciality hospitals with multiple facilities and huge patient accommodation capabilities.

As more and more patients coming from aboard, many doctors feel that the concept of health tour operators or agencies should be popularized in the city so that patients don’t get cheated by unregistered agents.

Realizing the fact, that India provides high quality medical treatment for a cheaper cost, medical tourists especially patients from West Asian and African countries, come to the city even for common health issues. The corporate hospitals usually pay a commission of 20 per cent to the agents and individual doctors for referring foreign patients to their hospitals. These agents also provide services like making arrangements for local stay, fixing appointment with doctors and acting as translators.

Full time agents are also employed by prominent corporate hospitals to promote themselves in the foreign countries. A source from a private hospital said, “We also have a marketing department and international division to promote ourselves. Our personnel go to west Asian and African countries and stay in touch with the hospitals and agents there who in turn refer patients to our hospital for high-end treatment.”

“We employ well experienced staff who can translate local language and have prior experience of working in foreign countries. We also coordinate with foreign agencies and medical tour operators. These operators send us the medical records of the patients who directly pay to these agencies,” said a spokesperson from Asian Institute of Gastroenterology, Hyderabad.

Source: Pharmabiz

India get 12 new drug Advisory Committees to help DCGI

The Union health ministry has formed 12 New Drug Advisory Committees (NDAC), comprising experts in the respective fields, to advise the Drugs Controller General of India (DCGI) in matters for review of applications of new drugs and clinical trials.

Each of the panels set up to advise in matters related to review and regulatory approval of clinical trials and new drugs, except for Investigational New Drugs (INDs), relating to different therapeutic areas, has ten members. The panels were formed on reproductive and urology, cardiovascular and renal, ophthalmology, vaccines, dermatology and allergy, anaesthetics and rheumatology, neurology and psychiatry, pulmonary, oncology and haematology, gastroenterology and hepatology, metabolism and endocrinology, and antimicrobial-antiparasitic-antifungal-antiviral areas.

“The committee will advise DCGI in matters to undertake in-depth evaluation of non-clinical data including pharmacological toxicological data, clinical trial data (phase I, II, III, and IV) furnished by the applicant for approval of new drug substances of chemical and biological origin to be introduced first time in the country including vaccines and r-DNA derived products,” according to an official note by the health ministry.

The panels will also evaluate data being submitted by the applicants on global clinical trials, fixed dose combinations of two or more drugs to be introduced for the first time in the country. It will help preparing guidelines for clinical research industry in evolving acceptance criteria for marketing approval of new drugs of different therapeutic categories. The panel will also define roadmap for research industry for appropriate development of new drugs relevant to Indian population.

“While considering cases of new drugs, the committee will examine essentiality and desirability of new drugs in terms of assessment of risk versus benefit to the patient, innovation vis-à-vis existing therapeutic option and unmet medical need in India,” the note said.

Application for new drugs and global clinical trials will be evaluated by the committee either through meetings or by circulation of the applications. The term of the committees is for three years. Office of the DCGI will initially examine the applications and if any data is lacking the same will be informed to the applicant within 45 working days or else the data will be forwarded to the members of the committee in the respective areas

NHRC ON HUMAN TRIALS

Last month, National Human Rights Commission asked Indian Council of Medical Research and the office of Drugs Controller General of India to provide a detailed report on the status of clinical trials being conducted in India. NHRC’s demand is in the wake of growing number of deaths taking place while conducting clinical trials in the country during the last two to three years. As per the health ministry’s records, 671 persons had died during clinical trials last year and a majority of them were sick volunteers. And the ministry admits that most of the dead volunteers were not given any compensation by the CROs or the pharmaceutical companies. It is unfortunate that the pharmaceutical companies and their agents getting away with this kind of gross unethical practices in the name clinical trials. Ever since the clinical trials started on a big scale in the country, reports were appearing in the media about the unethical practices indulged in by CROs in clinical research. The health ministry is fully aware of this fact but has not been taking any serious steps to bring in effective regulation in this sector.  This is despite the demands for enforcing proper regulations to monitor and control clinical trials from various sections of the society. A public interest litigation is expected to come up in the Allahabad High Court calling for a ban on all clinical trials until specific laws to govern trials are in place. Civil society groups have alleged that clinical trial monitoring is not mandated under the Drugs & Cosmetics Act 1940 and yet the government is regulating the trials as per the provisions of the Act.

The health ministry has been working for last ten years to put in place a set of comprehensive rules to regulate clinical research with flow of large number of contract research jobs into the country. Country cannot afford to have such laxity in enforcing appropriate laws to this vital area of medical research. Multinationals and CROs are aware of this deficiency in law and they are fully exploiting the situation at the cost of human lives. What the country has a set of guidelines after amendment of the Schedule Y of Drugs & Cosmetics Act. There are no indications when these rules will be finalised and implemented. It is in the background of this uncertainty, health ministry made it mandatory for the CROs to register themselves in July 2009 to have some accountability. Even this registration process is not progressing as expected. Ethics Committees at most of the trial sites are also not active with no proper monitoring of trials. Considering this dismal state of affairs in regulating clinical trial sector, NHRC's action is a welcome step to generate some public interest and action.

Source: Pharmabiz

Over-the-counter asthma inhalers containing chloroflouorocarbons (CFCs) will no longer be made or sold after Dec. 31, 2011

The U.S. Food and Drug Administration says users of epinephrine inhalers containing chlorofluorocarbons (CFCs) should plan now to get a prescription for a replacement product because these inhalers will not be made or sold after Dec. 31, 2011.

Epinephrine inhalers, marketed by Armstrong Pharmaceutical Inc. as Primatene Mist, are the only FDA-approved inhalers for the temporary relief of occasional symptoms of mild asthma that are sold over-the-counter in retail stores without a prescription. The product uses CFCs to propel the medicine out of the inhaler so that consumers can breathe it into their lungs.

However, Primatene Mist will no longer be available by year’s end because no CFC-containing epinephrine inhalers can be made or sold after Dec. 31, 2011, to comply with obligations made under the Montreal Protocol on Substances that Deplete the Ozone Layer. This is an international agreement signed by the United States, in which countries agreed to phase-out substances that deplete the ozone layer, including CFCs, after certain dates.

“If you rely on an over-the-counter inhaler to relieve your asthma symptoms, it is important that you contact a health care professional to talk about switching to a different medicine to treat your asthma,” said Badrul Chowdhury, M.D., director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

The FDA began public discussions about the use of CFCs in epinephrine inhalers in January 2006. The FDA finalized the phase-out date for using CFCs in these inhalers and notified the public in November 2008. Many manufacturers have changed their inhalers to replace CFCs with an environmentally-friendly propellant called hydrofluoroalkane (HFA). There is currently no HFA version of epinephrine inhalers.

There are, however, many other safe and effective inhalers to treat asthma symptoms. All of these inhalers require a prescription, which must come from a licensed health care professional (physician, physician’s assistant or nurse practitioner). Current epinephrine inhaler users that don’t have a health care professional to write them a new prescription can ask a family member or friend what doctor they use and would recommend, or they can visit a federally-qualified health center, local clinic, community health center, or minute-clinic (sometimes located in pharmacies) to see a health care professional and get a prescription.

Primatene Mist already carries a prominent notice about the phase-out date on its product label, and the FDA encourages Armstrong Pharmaceutical to further educate consumers as the deadline approaches to ensure an incident-free transition. The agency also will continue to work with retailers and pharmacies to facilitate a smooth phase-out of this CFC product and is prepared to review applications for replacement products.

Kokilaben Dhirubhai Ambani Hospital identifies three new mutations of Wilson disease

In a first of its kind project in India, funded by the European Union, Kokilaben Dhirubhai Ambani Hospital doctors Mohit Bhatt and Annu Aggarwal have just identified three new mutations or genetic defects of Wilson disease (WD). They are collaborating with Germany and Greece to study the genetic cause of Wilson disease, and understand the its mechanism.

DNA codes in a person provides with the genetic information of his life and is present in all living things. Finding the defect can help doctors understand why the disease has developed and what we can do to treat the disease.

Dr Bhatt, Dr Aggarwal and their colleagues have identified three new defects in DNA of their patients with Wilson disease. This breakthrough is helping them study why the disease has developed.

The next step of their research is to study what medicine will help in treatment of the genetic defect. There has been some exciting results wherein they have been able to predict in the laboratory if a particular Wilson disease medicine will help a particular patient or not. If these findings are confirmed then it will be possible to decide which medicine to be administered to the patients just on the results of the blood test of a Wilson disease patients. 

WD is an inherited disorder leading to excessive copper deposition primarily in liver and brain. Patients develop jaundice, memory and behavioural problems, movement disorders and joint pains. The disease starts within the first twenty years of life and can be fatal if let untreated.

However, with timely diagnosis and treatment, patients with WD can lead a normal life. Even people with severe disability can improve and resume their school or work. Its treatment involves copper depletion (or chealtion) and is required to be continued lifelong with close monitoring.

Unfortunately, there is little understanding of the disease even among specialists. Dr Bhatt and Dr Aggarwal have shown that a patient with WD on an average visits at least 11 doctors including liver specialists, neurologists, paediatricians, haematologists and other specialists before the disease is diagnosed. In fact, it is not unusual for families to have lost two to three childrens' before WD is diagnosed in the youngest child.

Keeping pace with the ongoing scientific revolution in neurological diseases and their treatment, Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Mumbai, recently established a Centre for Brain and Nervous System.

The centre is the first of its kind department in the country where each consultant focuses on a particular area of neurology, like movement disorders, Alzheimer and memory related diseases, stroke, epilepsy and paediatric neurology. This model of subspecialist and super-specialist neurology is complimented by state of the art infrastructure and cutting edge technology to provide comprehensive neurology services at par with the best centres in the world.

Currently the hospital helps make a difference in the lives of over 4,000 patients with neurological disorders and their families every year, with the number growing over time.

Source: Pharmabiz

FAILING R&D of MNCs

World’s top pharmaceutical companies are heading for a major crisis as they are continuously failing to bring out new molecules with potential to turn them into blockbusters. At the same time the R&D expenditures of most of these companies are steadily on the rise. A situation like this if persisted can endanger the very existence of these companies as their profitability is getting eroded. The trend of failing R&D in pharmaceutical industry is illustrated by a recent  study of R&D expenditures of 15 top global pharma companies conducted by Pharmabiz. The study shows that during the first half of 2011, these companies spent 8.2 per cent more on R&D at 41.06 billion US dollars as compared to the same period of the previous year with no major breakthrough products. In 2010, the R&D expenditure of these 15 global pharma companies went up by 15.5 per cent at 88.60 billion dollars. However, R&D expenditure as percentage of pharmaceutical sales of 15 companies remained unchanged at 17.8 per cent during first half of 2011. Novartis, AstraZeneca, Eli Lilly and a few others have stepped up their R&D expenditures during the first half with Novartis spending 16.7 per cent more, Eli Lilly  spending 7.1 per cent more and AstraZeneca 2.1 per cent more. Pfizer, Merck & Co and GSK spent slightly less on R&D during the first half of 2011. Pfizer's R&D spending declined by 1.7 per cent to $ 4.33 billion during the first half while that of GSK’s R&D expenditure declined by 12.9 per cent to $3.09 billion during the same period.

This is happening at a time when more and more products of top companies are losing their blockbuster status. Over a dozen products of top companies have lost their blockbuster position during the first half of the current year on account of a steady drop in sales. It is likely that several other blockbuster products may also face declining sales in the second half of 2011. Pfizer is going to witness the biggest setback of its life time in the current year when  Lipitor loses its patent in November hitting a revenue stream of $10 billion. The problem with the global pharmaceutical industry is not that they are not getting enough drug candidates from their research labs but these candidates are not reaching the market place. Take the case of two largest pharma companies, Pfizer and GSK. Pfizer has 25 products in the Phase III as on August 11, 2011, 31 projects in Phase II and 37 in Phase 1. GSK is expected to have 15 products in Phase III by the end of 2011 and by the end of 2012 it expects to have  more than 30 in Phase III. Now the question is how many of these candidates would be able to pass the regulatory hurdles. The number of new drugs approved for marketing has been steadily falling despite rising public and private spending for research and development. Approval of new drugs by the US FDA  has dropped from an average of more than 35 a year in the mid-1990s to just 20 in 2009. For the regulatory authorities, clearances have to be tight as increasing number of drugs are failing in the market after the marketing approvals are given. R&D in pharmaceutical industry is thus becoming a less productive activity and therefore a burden on the company managements. It is time for global pharma to invent new strategies in drug research instead of just spending more every year.

Source:Pharmabiz

FDA - Calendar September 2011

UPCOMING MEETINGS

13th International Paul-Ehrlich-Seminar - Allergen Products for Diagnosis and Therapy: Regulation and Science DATE: September 14-17, 2011 TIME: 8:00 a.m. to 5:00 p.m. LOCATION: Hyatt Regency Washington on Capitol Hill, 400 New Jersey Ave NW, Washington, DC 20001-2097 This meeting will provide a forum to focus on the scientific and regulatory issues regarding the use of allergenic products to diagnosis and treat allergic diseases, as well as the impact of these issues on specialty practice and in the clinical setting. Public Meeting - Recommendations Proposed in Institute of Medicine Report: "Medical Devices and the Public’s Health, The FDA 510(k) Clearance Process at 35 Years" DATE: September 16, 2011 TIME: 8:30 a.m. to 5:00 p.m. LOCATION: Silver Spring Hilton Hotel, 8727 Colesville Rd, Silver Spring , MD, 20910 The purpose of the meeting is to encourage public comment on the recommendations proposed in the Institute of Medicine (IOM) report. Public Workshop - The Development and Evaluation of Next-Generation Smallpox Vaccines DATE: September 16, 2011 TIME: 8:00 a.m. to 5:30 p.m. LOCATION: Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877 The purpose of the public workshop is to identify and discuss the key issues related to the development and evaluation of next-generation smallpox vaccines. The public workshop will include presentations on the human response to smallpox vaccines and development of animal models for demonstration of effectiveness of next-generation smallpox vaccines. Town Hall Discussion With the Director of CDRH and Other Senior Center Management DATE: September 22, 2011 TIME: 8:00 a.m. to 12:00 p.m. LOCATION: The Embassy Suites Hotel, San Francisco Airport, 250 Gateway Boulevard, South San Francisco, CA 94080 The objective of this Town Hall meeting is to engage in a dialogue about issues that are of importance to the public. Pediatric Advisory Committee Meeting DATE: September 22-23, 2011 TIME: 8:00 a.m. to 5:30 p.m. LOCATION: Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877 On Thursday, September 22, 2011, the committee will discuss Fluarix (influenza virus vaccine), Afluria (influenza virus vaccine), and Abilify (aripiprazole). There will also be an update on a study jointly funded by the Agency for Healthcare Research and Quality (AHRQ) and FDA on antipsychotic use and metabolic effects in children. On Friday, September 23, 2011, the committee will discuss Akten (lidocaine hydrochloride), Famvir (famciclovir), Levaquin (levofloxacin), Navstel (balanced salt ophthalmic solution with hypromellose, dextrose, and glutathione), Retrovir (zidovudine), Topamax (topiramate), Triesence (triamcinolone acetonide injectable suspension), Videx EC (didanosine), Ziagen (abacavir sulfate), and Zomig Nasal Spray (zolmitriptan). There will be an informational update on Kaletra (lopinavir/ritonavir) oral solution and tablets. Cellular, Tissue and Gene Therapies Advisory Committee Meeting DATE: September 22-23, 2011 TIME: 8:00 a.m. to 5:00 p.m. LOCATION: Hilton Hotel Washington DC North/Gaithersburg, 620 Perry Parkway, Gaithersburg, MD 20977 On September 22, 2011, the committee will discuss BLA 125397, Umbilical Cord Blood, New York Blood Center, indicated for hematologic malignancies, bone marrow failure, primary immunodeficiency diseases, beta thalassemia, Hurler syndrome, Krabbe disease, and X-linked adrenoleukodystrophy. On September 23, 2011, the committee will discuss HDE BH110018, CliniMACS CD34 Selection System, Miltenyi Biotec, for processing allogeneic HLA-matched hematopoietic progenitor cells-apheresis (HPC-C) from a related donor to obtain a CD34+ cell population intended for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional graft-vs-host disease (GVHD) prophylaxis in patients with acute myelogenous leukemia in first or second morphologic complete remission. Public Workshop - Approach to Addressing Drug Shortage DATE: September 26, 2011 TIME: 8:30 a.m. to 4:30 p.m. LOCATION: FDA White Oak Campus, Building 31, The Great Room (Rm. 1503), 10903 New Hampshire Avenue, Silver Spring, Maryland 20993 This public workshop is intended to provide information for, and to gain additional insight from, professional societies, patient advocates, industry, consumer groups, health care professionals, researchers, and other interested persons about the causes and impact of drug shortages, and possible strategies for preventing or mitigating drug shortages. The input from this public workshop will help in developing topics for further discussion with industry and professional societies, and other stakeholders and may help the Agency to better address drug shortage issues. Tissue Adhesives / Soft Tissue Workshop / Symposium DATE: September 26-27, 2011 TIME: 8:30 a.m. to 4:30 p.m. LOCATION: FDA White Oak Campus, Building 2, A-2031, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993 The purpose of the workshop/symposium is to facilitate medical device innovation with the focus on tissue adhesive materials. Medical Device Alarms Summit DATE: October 4-5, 2011 TIME: October 4, 8:00 a.m. to 5:30 p.m.; October 5th, 8:30 a.m. to 5:00 p.m. LOCATION: Hyatt Dulles Hotel, 2300 Dulles Corner Blvd., Herndon, Virginia Stakeholders will develop priorities on the key issues with the safety and effectiveness of medical device/system alarms. Public Meeting - Advancing Regulatory Science for Highly Multiplexed Microbiology/MCM Devices DATE: October 13, 2011 TIME: 8:00 a.m. to 6:00 p.m. LOCATION: FDA White Oak Campus, Building 31, The Great Room (Rm. 1503), 10903 New Hampshire Avenue, Silver Spring, Maryland 20993 The purpose of the public meeting is to discuss performance evaluation of highly multiplexed microbiology/medical countermeasure (MCM) devices, their clinical application and public health/clinical needs, and quality criteria for establishing the accuracy of reference databases . Immunology Devices Panel of the Medical Devices Advisory Committee Meeting DATE: October 14, 2011 TIME: 8:00 a.m. to 6:00 p.m. LOCATION: Hilton Washington DC North/Gaithersburg, salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD 20977. The committee will discuss the Progensa PCA3 assay sponsored by Gen-Probe, Inc., indicated for use in conjunction with other patient information to aid in the decision for repeat biopsy in men 50 years of age or older who have had one or more previous negative prostate biopsies and for whom a repeat biopsy would be recommended based on current standard of care, before consideration of PCA3 assay results. Public Meeting - Prescription Drug User Fee Act Reauthorization DATE: October 24, 2011 TIME: 9:00 a.m. to 5:00 p.m. LOCATION: FDA White Oak Campus, Building 31, The Great Room (Rm. 1503), 10903 New Hampshire Avenue, Silver Spring, Maryland 20993 The purpose of the public meeting is to a discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA), which authorizes FDA to collect user fees and use them for the process for the review of human drug applications for fiscal years (FYs) 2013 through 2017. Food and Drug Administration Health Professional Organizations Conference DATE: October 31, 2011 TIME: 8:00 a.m. - 1:30 p.m. LOCATION: FDA White Oak Campus, Building 31, The Great Room (Rm. 1503), 10903 New Hampshire Avenue, Silver Spring, Maryland 20993 The aim of the conference is to further the public health mission of the FDA through training, collaboration, and structured discussion between health professional organizations and FDA staff. Please visit FDA’s Advisory Committee page (http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm) to obtain advisory committee meeting agendas, briefing materials, and meeting rosters prior to the meetings. You may also visit this page after meetings to obtain transcripts, presentations, and voting results. For additional information on other agency meetings please visit Meetings, Conferences, & Workshops (http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/default.htm).

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Weight loss as Symptomatic Treatment for Knee Osteoarthritis

A research study conducted by Henning Biddal et al at the Parker Institute, Denmark whose results were published in the Annals of Rheumatic Diseases has shown that weight loss program was successful in lessening the pain in patients with Osteoarthritis.

The study was a 1-year randomized controlled trial conducted to evaluate 1-year symptomatic improvement in obese patients with knee osteoarthritis (OA) on an intensive low-energy diet (LED) maintained by frequent consultations with a dietician compared to minimal attention. The LED programme consisted of group therapy with dietary consultations and two periods of a low-calorie diet of 810 kcal/day during weeks 0–8 and weeks 32–36. The control group only received dietary instruction and attention for 2 h at baseline, and at weeks 8, 32, 36 and 52. Primary end point (total Western Ontario and McMaster Universities (WOMAC) index) was assessed as the mean group difference during and after 1 year. After 1 year, mean weight loss in the LED group was –10.9 kg (11%) versus –3.6 kg (4%) in the control group. There was no difference between the groups in total WOMAC index (p=0.11), although both groups improved. However, the LED intervention resulted in less WOMAC pain (7.7 mm), with a group mean difference of 7.2 mm. After one year 14 (32.8%) responded to LED versus 7 (15.6%) to control, with an absolute benefit of 16.3%. Continuous reinforcement of a weight loss programme can be successful over a year in obese knee OA patients. Weight loss was statistically reflected only by a reduction in pain.

Ref: Ann Rheum Dis 2011;70:1798-1803 doi:10.1136/ard.2010.142018

FDA announces changes in drug center’s oncology office

The US Food and Drug Administration announced organizational changes within the office responsible for reviewing all drug and biologic applications for cancer therapies. The Center for Drug Evaluation and Research’s (CDER) Office of Oncology Drug Products has been reorganized and renamed the Office of Hematology and Oncology Products (OHOP).

“Under the new office structure, the agency anticipates greater clarity and more transparent interactions with companies about the requirements to bring cancer treatments to market,” said CDER director Janet Woodcock, M.D. “We don’t expect these changes to slow down pending applications, in fact, we expect to see greater efficiencies that will better support our work to get cancer treatments to patients.”

Richard Pazdur, M.D., who joined the FDA in 1999 and became director of the office in 2005, will continue to serve as the office director. Dr. Pazdur will also continue to head the agency-wide oncology program that coordinates oncology activities within the FDA as well as with external stakeholders. This program will remain in OHOP.

“As the practice of oncology and the treatments being developed for these diseases have become more complex, we’ve recognized the need and importance of taking a more disease-specific review approach to these therapies,” said Dr. Pazdur. “Reorganizing the office in this manner also aligns FDA with the organizational structure of leading cancer treatment centers, academic programs and the National Cancer Institute.”

The previous structure contained three divisions: Division of Hematology Products (DHP), Division of Drug Oncology Products (DDOP), and Division of Biologic Oncology Products (DBOP).

The new structure contains four divisions: Division of Hematology Products (DHP), Division of Oncology Products 1 (DOP1), Division of Oncology Products 2 (DOP2), and Division of Hematology Oncology Toxicology (DHOT).

Two unique features of the reorganization include the creation of DOP1 and DOP2, the agency’s primary review divisions for cancer solid tumor therapies, and the creation of DHOT, which will review nonclinical information.

DOP1 and DOP2 will have disease-specific therapeutic areas of responsibility regardless of whether the product is a drug or biologic. DHOT is a newly created division that will be dedicated to reviewing nonclinical pharmacology and toxicology aspects of cancer therapies. DHP will continue reviewing hematology therapies, including those for benign disorders and malignancies. The division directors for each division are listed below.

New OHOP Structure and Division Therapeutic Areas

DOP1	DOP2	DHP	DHOT
Division Director Robert Justice, M.D., M.S.	Division Director Patricia Keegan, M.D.	Division Director Ann Farrell, M.D.	Division Director John Leighton, Ph.D.
Breast, Gynecologic, Genitourinary, Supportive care (non-hematologic)	Gastrointestinal, Lung/Head & Neck, Neuro-oncology/Rare cancers/Pediatric Solid Tumor, Melanoma/Sarcoma	Benign hematology, Hematologic malignancies, Hematology support, Pediatric Hematology	Nonclinical Review Division for Hematology/Oncology products

OHOP at-a-glance

• 130: total employees in OHOP
• 55: number of medical oncologists in OHOP
• 39: number of pharmacists, nurses and non-clinical Ph.D.s in OHOP
• 19: Number of medical oncologists, nurses and pharmacists still treating patients
• 24: OHOP staff published in 2010
• 10: number of new drug indications approved in 2010
• 7: number of new molecular entities approved to date in 2011