Male circumcision shown to help prevent HIV transmission

By Dr Ananya Mandal, MD

According to a new study published in the Medical Journal of Australia, male circumcision can be seen as a “surgical vaccine” in the fight against heterosexual HIV transmission. The study based on spread of the virus in Africa showed that there was a reduced rate of transmission in regions where male circumcision was the norm.

According to co-author St Vincent's Hospital Alcohol and Drug Service director Alex Wodak this practice could be introduced as a long-term strategy in reducing heterosexual HIV transmission. He explained, “A wealth of research has shown that the foreskin is the entry point that allows HIV to infect men during intercourse with an infected female partner…Soon after the HIV pandemic was first recognized, much lower HIV prevalence was found in areas of sub-Saharan Africa, where more than 80 per cent of males had been circumcised than in areas where the circumcision rate was less than 20 per cent…Circumcision of males is now being referred to by many as 'surgical vaccine' against a wide variety of infections and adverse medical conditions over a lifetime.”

Speaking on Australia Dr. Wodak said that in the 50’s and 60’s more than 80 per cent of infant males were circumcised and recent Medicare statistics revealed circumcision among Australian boys had increased from 13 per cent in 1998 to 19 per cent in 2009. He said, “If Australia returned to the patterns we had in the 1950s and 1960s, I think that would be beneficial.”

Studies have failed to show similar benefits of male circumcision when it comes to sex between men. According to the World Health Organization there is “compelling evidence that male circumcision reduced the risk of heterosexually acquired HIV infection in men by approximately 60 per cent.”

Dr. Wodak went on to say that this simple surgical procedure also protects from some common sexually transmitted infections and other conditions such as urinary tract infections. He added, “The prospect of the availability of a (HIV) vaccine over the next 20 years is unlikely… Condom use remains essential, with promotion of condom use plus circumcision of males being analogous to seatbelts plus airbags for reducing the road toll.”

However Australian National University department of pediatrics and child health associate Professor Graham Reynolds feels this surgery is not imperative for prevention of infections. He said, “In order to prevent one infection, you circumcise unnecessarily a huge number of children who will never get a urinary infection, who will never get HIV, who will never get any other infection…if we paid proper attention to cleanliness in non-circumcised boys, we would get no problems.”

courtesy-http://www.news-medical.net/news

Dengue fever vaccine in the pipeline

By Dr Ananya Mandal, MD

Australians researchers are moving towards producing the first ever vaccine for dengue fever, the potentially life-threatening infection spread by mosquitoes in the tropics. At present late stage clinical trials are underway for a vaccine that would protect against all four known strains of the disease. Participants are now being recruited in Perth, Adelaide and Brisbane.

According to Associate Professor Peter Richmond, from Perth's Telethon Institute for Child Health Research, participants would be injected with the vaccine and their blood later checked for protective antibodies. He said that this vaccine once developed would be a boon for South east Asia where the disease is a true menace. “There are more than two hundred million infections annually, that's the estimate, and a couple of million (infected people) get a very severe form of Dengue hemorrhagic fever…From a global perspective, having an effective vaccine is very important,” he said.

Considering world population, over fifty percent live in areas at high risk of dengue fever that is usually fatal in children and adults alike. It causes fever and severe headache, vomiting, muscle and joint pain and skin rash. Australia also has sporadic outbreaks of the infection both from travelers and in the northern Queensland range of its specific type of carrier mosquito.

The vaccine is developed and the trials are being sponsored by pharmaceutical company Sanofi Pasteur. The vaccine is expected in five years.

courtesy- http://www.news-medical.net/news/20100920/Dengue-fever-vaccine-in-the-pipeline.aspx

Dilation Of Blood Vessels Restores Muscle Synthesis In Elderly

University of Texas Medical Branch at Galveston researchers believe they've found a way to use widely available blood pressure drugs to fight the muscular weakness that normally accompanies aging.

The discovery draws on research linking the loss of muscle mass with age-related changes in the behavior of the hair-thin blood vessels, or capillaries, which supply muscles with the amino acids they need for growth.

"When a young person eats food, insulin secretion causes the blood vessels in the muscle to dilate, so a lot of blood goes into the muscle and a lot of amino acids are available to build muscle proteins," said UTMB professor Elena Volpi, senior author of a paper on the work ("Pharmacological vasodilation improves insulin-stimulated muscle protein anabolism but not glucose utilization in older adults") now available in the "Online Ahead of Print" section of the journal Diabetes. "Older people's blood vessels have far less response to insulin, but we found that if you give them a drug that causes them to dilate, you can increase the nutritive flow to the muscles and completely restore normal growth."

Drugs that induce blood vessels to widen, called vasodilators, are commonly used to control high blood pressure and prevent angina. The UTMB study used sodium nitroprusside, a drug used in hospitals and administered intravenously.

The researchers enrolled 12 healthy older volunteers for the study, and separated them randomly into two six-person groups. Working in UTMB's Clinical Research Center, the investigators performed the delicate task of inserting catheters into the arteries and veins feeding and draining the subjects' leg muscles, and then used the arterial catheter to infuse the muscles with insulin at levels similar to those generated by a meal. One group of volunteers was given the vasodilator drug, while the other received a placebo.

Blood sample and muscle biopsy analysis produced estimates of muscle protein synthesis and breakdown. The results were impressive: virtually normal muscle growth in the older subjects given the vasodilator with insulin.

"By giving them this vasodilator, we were able to make our 70-year-olds look like 30-year-olds, at least in terms of muscle growth," said postdoctoral fellow Kyle Timmerman, a lead author of the paper. The study was co-led by medical student and graduate research fellow Jessica Lee.

While the researchers cautioned that larger studies would be needed to confirm their findings, they expressed optimism about vasodilator drugs' potential as tools for keeping older people from falling into frailty, and living happier, healthier and more independent lives.

"If by improving blood flow during and immediately after eating we can improve muscle growth in response to meals in older people, then we're going to have a major new tool to reduce muscle loss with aging," Volpi said. "By itself, that could mean a substantially decreased risk of physical dysfunction and disability."

Other authors of the paper include assistant professor Satoshi Fujita, senior study coordinator Shaheen Dhanani, assistant professor Hans Dreyer, graduate student Christopher Fry, assistant professor Micah Drummond, professor Melinda Sheffield-Moore and professor Blake Rasmussen.

The National Institute on Aging, the UTMB Claude D. Pepper Older Americans Independence Center and the UTMB Clinical and Translational Science Award supported this research.

Source:
Jim Kelly
University of Texas Medical Branch at Galveston

courtesyhttp://www.medicalnewstoday.com/articles/198549.php -

Development Of New Drug Treatment For Malaria

As part of the £1.5 million project, researchers are now testing the drug to determine how the treatment could progress to clinical trials. The drug is made from simple organic molecules and will be cheaper to mass produce compared to existing therapies.

Malaria is the world's most deadly parasitic infection, resulting in nearly one million deaths a year. The team at Liverpool have created a synthetic drug based on the chemical structure of artemisinin, an extract of a Chinese herb commonly used in malaria treatment. The new drug, which can be taken orally, is more potent than naturally derived artemisinin.

Artemisinin is known to interact with a substance inside parasite-infected red blood cells, causing a chain of events that destroys malaria. The treatment, however, is difficult to mass produce and can be chemically unstable in the body. Scientists have now found a way of creating the most reactive part of artemisinin synthetically and fusing it with a cage-like structure made of organic molecules to make the drug more chemically stable. The stability of the chemical structure in the body makes the drug last longer, reducing the chance of the parasite reappearing.

Professor Paul O'Neill, from the University's Department of Chemistry, explains: "Malaria affects the world's poorest countries and hospitals are unable to afford expensive treatments. The problem with current artemisinin-based therapies is their limited availability, poor oral absorption and high cost. We have created a new drug that is easily absorbed by the body, chemically stable and highly potent. It is made from very simple organic materials and therefore will be more cost-effective to mass produce than current therapies."

The research is funded by the European Commission and published in Angewandte Chemie Int Ed.

Source:
Samantha Martin
University of Liverpool

courtasy-http://www.medicalnewstoday.com/articles/197982.php

FDA Allows Lupin To Apply To Sell Copies Of Pfizer's Lipitor

cortasy :- First Published Thursday, 2 September 2010 09:19 pm - © 2010 Dow Jones

By Peter Loftus

Of DOW JONES NEWSWIRES

The U.S. Food and Drug Administration has given permission to Indian generic-drug maker Lupin Ltd. (500257.BY) to seek approval for a generic version of Pfizer Inc.'s (PFE) blockbuster cholesterol drug Lipitor with a different formulation than the original drug.

The FDA decision, however, isn't likely to result in the introduction of the Lupin product anytime soon. Lupin still must go through the normal generic-drug approval process before it can launch its proposed capsule version of Lipitor--the original product is a tablet--and agency reviews can take upwards of two years.

New York-based Pfizer said in a written statement Thursday that it believes the FDA decision on Lupin's request has no effect on its prior Lipitor patent settlement with Ranbaxy Laboratories Ltd. (500359.BY), which is expected to keep generic copies of Lipitor off the U.S. market until November 2011.

A Lupin spokeswoman declined to comment.

Lupin is one of several generic-drug manufacturers eyeing a piece of what promises to be a big market opportunity. The original Lipitor is the top-selling prescription drug in the world, with $11.4 billion in global sales last year and $5.7 billion in the U.S. alone.

Lipitor's impending loss of U.S. market exclusivity will be a major financial blow to Pfizer, which has cut costs and diversified its business lineup in preparation.

In 2008, Lupin filed a citizen petition with the FDA asking for permission seek approval of the capsule version of Lipitor. Lupin said it wanted to market a capsule version for people who have difficulty swallowing a tablet or prefer a capsule form.

The FDA last week granted Lupin's request, according to a letter posted online by the agency. The agency said Lupin's proposed capsule version of Lipitor wouldn't pose questions of safety or effectiveness, since the uses and oral route of administration are the same as the original tablet.

A capsule typically has a gelatinous exterior with the active ingredient inside, sometimes in powder form. Currently, Pfizer sells solid-tablet versions of Lipitor, which is approved to lower cholesterol and reduce the risk of heart attacks.

Because Lupin's product would be a different formulation, pharmacies wouldn't be able to automatically substitute it for branded Lipitor prescriptions, Pfizer said. Instead, doctors would have to specifically prescribe the capsule version if they or patients wanted the Lupin product.

Pfizer has U.S. patents for Lipitor that expire this year and in 2011, 2016 and 2017. The company had sued Ranbaxy after Ranbaxy challenged the patents' validity, and in 2008 the companies settled their litigation. Pfizer granted Ranbaxy a license to begin selling generic Lipitor in the U.S. effective Nov. 30, 2011.

Other generic-drug companies have filed for FDA approval to sell generic Lipitor, and Pfizer has filed patent-infringement suits that are pending in U.S. courts. Under federal law, Ranbaxy is expected to have a 180-day period of exclusivity to sell a third-party generic Lipitor.

In addition, Pfizer has granted Watson Pharmaceuticals Inc. (WPI) exclusive rights to sell what is known as an authorized generic version of Lipitor in the U.S. for five years, beginning in November 2011. Pfizer will manufacture and sell Lipitor's active ingredient, atorvastatin, to Watson for use in the authorized generic product, the company disclosed in a recent regulatory filing.

-By Peter Loftus, Dow Jones Newswires; +1-215-656-8289; peter.loftus@dowjones.com

New Oral Contraceptive

The U.S. Food and Drug Administration today approved ella™ (ulipristal acetate) tablets for emergency contraception. The prescription-only product prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. It is not intended for routine use as a contraceptive.

ella is a progesterone agonist/antagonist whose likely main effect is to inhibit or delay ovulation. Since May 2009, the prescription product has been available in Europe under the brand name ellaOne.

An FDA Advisory Committee for Reproductive Health Drugs discussed ella in June, 2010. The committee unanimously voted that the application for ella provided compelling data on efficacy and sufficient information on safety for the proposed indication of emergency contraception.

The safety and efficacy of ella were demonstrated in two Phase III clinical trials. One study was a prospective, multi-center, open-label, single-arm trial conducted in the United States; the other was a randomized, multi-center, single-blind comparator-controlled trial conducted in the United States, United Kingdom and Ireland.

Side effects most frequently observed with ella in the clinical trials include: headache, nausea, abdominal pain, pain/discomfort during menstruation (dysmenorrhea), fatigue, and dizziness. The profile of side effects for ella is similar to that of FDA-approved levonorgestrel emergency contraceptives.

According to the product’s labeling, women with known or suspected pregnancy and women who are breastfeeding should not use ella. A patient package insert also will be provided to ensure that women are fully informed of the benefits and risks involved in the use of ella.

LIST OF DRUGS PROHIBITED FOR MANUFACTURE AND SALE THROUGH GAZETTE NOTIFICATIONS UNDER SECTION 26A OF DRUGS & COSMETICS ACT 1940 BY THE MINISTRY OF HEA

DRUGS PROHIBITED FROM THE DATE OF NOTIFICATION

1. Amidopyrine

2. Fixed dose combinations of vitamins with anti-inflammatory agents and tranquilizers.

3. Fixed dose combinations of Atropine in Analgesics and Antipyretics.

4. Fixed dose combinations of Strychnine and Caffeine in tonics.

5.Fixed dose combinations of Yohimbine and Strychnine with Testosterone and Vitamins.

6. Fixed dose combinations of Iron with Strychnine, Arsenic and Yohimbine.

7. Fixed dose combinations of Sodium Bromide/chloral hydrate with other drugs.

8. Phenacetin.

9. Fixed dose combinations of antihistaminic with anti-diarrhoeals.

10. Fixed dose combinations of Penicillin with Sulphonamides.

11. Fixed dose combinations of Vitamins with Analgesics.

B12.Fixed dose combinations of any other Tetracycline with Vitamin C.

E13.Fixed dose combinations of Hydroxyquinoline group of drugs with any other drug except for preparations meant for external use.

ccc14. Fixed dose combinations of Corticosteroids with any other drug for internal use.

ccc15. Fixed dose combinations of Chloramphenicol with any other drug for internal use.

16.Fixed dose combinations of crude Ergot preparations except those containing Ergotamine, Caffeine, analgesics, antihistamines for the treatment of migraine, headaches.

17.Fixed dose combinations of Vitamins with Anti TB drugs except combination of Isoniazid with Pyridoxine Hydrochloride (Vitamin B6).

18. Penicillin skin/eye Ointment.

19. Tetracycline Liquid Oral preparations.

20. Nialamide.

21. Practolol.

22. Methapyrilene, its salts.

c 23. Methaqualone.

& 24. Oxytetracycline Liquid Oral preparations.

& 25. Demeclocycline Liquid Oral preparations.

T 26. Combination of anabolic Steroids with other drugs.

cc 27.Fixed dose combination of Oestrogen and Progestin (other than oral contraceptive) containing per tablet estrogen content of more than 50 mcg (equivalent to Ethinyl Estradiol) and progestin content of more than 3 mg (equivalent to Norethisterone Acetate) and all fixed dose combination injectable preparations containing synthetic Oestrogen and Progesterone. (Subs. By Noti. No. 743 (E) dt 10-08-1989)

* 28.Fixed dose combination of Sedatives/ hypnotics/anxiolytics with analgesics-antipyretics.

J*29.Fixed dose combination of Rifanpicin, isoniazid and Pyrazinamide, except those which provide daily adult dose given below:

Drugs Minimum Maximum

Rifampicin 450 mg 600 mg

Isoniazid 300 mg 400 mg

Pyrazinamide 1000mg 1500 mg

* 30. Fixed dose combination of Histamine H-2 receptor antagonists with antacids except for those combinations approved by Drugs Controller, India.

* 31.The patent and proprietary medicines of fixed dose combinations of essential oils with alcohol having percentage higher than 20% proof except preparations given in the Indian Pharmacopoeia.

* 32. All Pharmaceutical preparations containing Chloroform exceeding 0.5% w/w or v/v
whichever is appropriate.

** 33.Fixed dose combination of Ethambutol with INH other than the following: INH
Ethambutol 200 mg. 600 mg. 300 mg. 800 mg.

** 34. Fixed dose combination containing more than one antihistamine.

B**35.Fixed dose combination of any anthelmintic with cathartic/purgative except for
piperazine/Santonim.

**36. Fixed dose combination of Salbutamol or any other bronchodilator with centrally acting anti-tussive and/or antihistamine.

** 37.Fixed dose combination of laxatives and/or anti-spasmodic drugs in enzyme preparations.

G** 38.Fixed dose combination of Metoclopramide with systemically absorbed drugs except fixed dose combination of metoclopramide with aspirin/paracetamol

** 39.Fixed dose combination of centrally acting, antitussive with antihistamine, having high atropine like activity in expectorants.

** 40.Preparations claiming to combat cough associated with asthma containing centrally acting antitussive and/ or an antihistamine.

** 41.Liquid oral tonic preparations containing glycerophosphates and/or other phosphates and / or central nervous system stimulant and such preparations containing alcohol more than 20% proof.

** 42.Fixed dose combination containing Pectin and/or Kaolin with any drug which is systemically absorbed from GI tract except for combinations of Pectin and/or Kaolin with drugs not systemically absorbed.

*** 43. Chloral Hydrate as a drug.

b 44. Dovers Powder I.P.

b 45. Dover’s Powder Tablets I.P.

A 46.Antidiarrhoeal formulations containing Kaolin or Pectin or Attapulgite or Activated Charcoal.

A 47.Antidiarrhoeal formulations containing Phthalyl Sulphathiazole or Sulphaguanidine or Succinyl Sulphathiazole.

A 48.Antidiarrhoeal formulations containing Neomycin or Streptomycin or Dihydrostreptomycin including their respective salts or esters.

A 49.Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing Diphenoxylate Lorloperamide or Atropine or Belladona including their salts or esters or metabolites Hyoscyamine or their extracts or their alkaloids.

A 50.Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing halogenated hydroxyquinolines.

A 51. Fixed dose combination of antidiarrhoeals with electrolytes.

C 52. Patent and Proprietary Oral Rehydration Salts other than those conforming to the following parameters:
(a) Patent and Proprietary Oral Rehydration Salts on reconstitution to one litre shall contain:- Sodium - 50 to 90 millimoles. Total osmolarity - 240 - 290 milli osmoles. Dextrose : Sodium molar ratio - Not less than 1:1 and not more than 3:1
(b) Patent and Proprietary cereal based Oral Rehydration Salts on reconstitution to one litre shall contain :- Total osmolarity - Not more than 2900 milli osmoles. Precooked rice- Equivalent to not less than 50 gm and not more than 80 gm as total replacement of Dextrose.
(c) Patent and Proprietary Oral Rehydration Salts (ORS) may contain aminoacids in addition to Oral Rehydration Salt conforming to the parameters specified above and labeled with the indication for "Adult Choleratic Diarrhoea" only.
(d) Patent and Proprietary Oral Rehydration Salts shall not contain Mono or Polysaccharides or saccharin sweetening agent.

D 53. Fixed dose combination of Oxyphenbutazone or Phenylbutazone with any other drug.

H.D54. Fixed dose combination of Analgin with any other drug.

D 55. Fixed dose combination of dextropropoxyphene with any other drug other than anti-spasmodics and/or non-steriodal anti-inflammatory drugs (NSAIDS).

D 56. Fixed dose combination of a drug, standards of which are prescribed in the Second Schedule to the said Act with an Ayurvedic, Siddha or Unani drug.

F 57. Mepacrine Hydrochloride (Quinacrine and its salts) in any dosage form for use for female sterilization or contraception.

F 58. Fenfluramine and Dexfenfluramine.

I 59. Fixed dose combination of Diazepam and Diphenhydramine Hydrochloride .

K 60. Rimonabant.

LIST OF GAZETTE NOTIFICATION PUBLISHED

The Principal Notification GSR 578 (E) dt.23.7.83.

c Added b GSR 4(E) dated 31.01.1984

& Added b GSR 322(E) dated 03.05.1984\

T Amended by GSR 863(E) dated 22.11.1985

cc Amended by GSR 743(E) dated 10.08.1989

ccc Amended by GSR 1057(E) dated 03.11.1988

* Added by GSR 999(E) dated 26.12.1990

* Added by GSR 69(E) dated 11.02.1991

xxx Added by GSR 304(E) dated 7.06.1990

@ Added by GSR 444(E) dated 7.06.1992

b Added by GSR 111(E) dated 22.02.1994

A Added by GSR 731(E) dated 30.09.1994

B Added by GSR 848(E) dated 7.12.1994

C Added by GSR 57(E) dated 7.02.1995

D Added by GSR 633(E) dated 13.09.1995

E Added by GSR 793(E) dated 13.03.1995

Added by GSR 93(E) dated 25.05.1997

F Added by GSR 499(E) dated 14.08.1998

G Added by GSR 394(E) dated 19.05.1999

H Added by GSR 405(E) dated 3.06.1999

I Added by GSR 169(E) dated 12.03.2001

J Added by GSR 290(E) dated 16.04.2008

K Added by GSR 885(E) dated 11.12.2009

List of Drugs Prohibited for Import

1. Nialamide

2. Practolol

3. Amiopyrine

4. Phenacetin

5. Methapyrilene and its salts

a 6. Methaqualone

b 7. Chloral Hydrate as a drug

c 8. Mepacrine Hydrochloride (Quinacrine and its salts) in any dosage form for use for female sterilization and contraceptive.

9. Fenfluramine and Dexfenfluramine

d 10. Rimonabant

List of Gazette Notification Pblished

a Added by GSR 48(E) dated 31.1.1984

b Added by GSR 303(E) dated 7.6.1991

c Added by GSR 498(E) dated 14.8.1998

d Added by GSR 884(E) dated 11.12.2009

DRUGS PROHIBITED FOR MANUFACTURE , SALE AND DISTRIBUTION FROM SUBSEQUENT DATE

Drugs Formulation Effective date Notification

1.Cosmetics Licensed as toothpaste/tooth With immediate GSR 444(E)

powder containing tobacco. effect dt.30.4.92

2.Parenteal Preparations fixed dose Jan 1,1998 GSR 93(E)

combination of streptomycin with dt.25.2.97

Pencillin

3.Fixed dose combination of Vitamin B1, Jan 1,2001 GSR 702(E)

Vitamin B6 and Vitamin B12 for dt.14.10.99

human use

4.Fixed dose combination of haemoglobin Sep 1,2000 GSR 814(E)

in any form (natural or synthetic). dt.16.12.99

5.Fixed dose combination of Pancreatin or Sept. 1,2000 GSR 814(E)

Pancrelipase containing amylase, protease dt.16.12.99

and lipase with any other enzyme.

6. Fixed dose combination of Nitrofurantoin Jan 1,2002 GSR 170(E)

and trimethoprim. dt.12.3.01

7.Fixed dose combination of Phenobarbitone Jan 1,2002 GRS 170(E)

with any anti-asthmatic drugs. dt.12.3.01

8.Fixed dose combination of Phenobarbitone Jan 1,2002 GSR 170(E)

with Hyoscin and/or Hyoscyamine dt.12.3.01

9.Fixed dose combination of Phenobarbitone Jan 1,2002 GSR 170(E)

with Ergotamine and/or Belladona dt.12.3.01

10.Fixed dose combination of Haloperidol Jan 1,2002 GSR 170(E)

with any anti-cholinergic agent including dt.12.3.01

Propantheline Bromide.

11.Fixed dose combination of Nalidixic Acid Jan 1,2002 GSR 170(E)

with any anti-amoebic including Metronidazole. dt.12.3.01

12.Fixed dose combination of Loperamide Jan 1,2002 GSR 170(E)

Hydrochloride with Furazolidone dt.12.3.01

13.Fixed dose combination of Cyproheptadine Jan 1,2003 GSR 170(E)

with Lysine or Peptone. dt.12.3.01

14.Astemizole Apr.1,2003 GSR 191(E)

dt.5.3.03

15.Terfinadine Apr.1,2003 GSR 191(E)

dt.5.3.03

16.Fenformin Oct.1,2003 GSR 780(E)

dt.1.10.03

17.Rofecoxib Dec 13,2004 GSR 810(E)
dt. 13.12.04

18.Valdecoxib July 25,2005 GSR 510(E)
and it's formulation dt. 25.07.05