19th Aug 2015, 05:16 PM #2061
Re: Health Bulletin
US FDA approves 'female Viagra' with strong warning
The first drug to treat low sexual desire in women won approval from US health regulators on Tuesday, but with a warning about potentially dangerous low blood pressure and fainting side effects, especially when taken with alcohol.
The US Food and Drug Administration said the pink pill, to be sold under the brand name Addyi and made by privately held Sprout Pharmaceuticals, will only be available through certified and specially trained health care professionals and pharmacies due to its safety issues.
Addyi, whose chemical name is flibanserin, is designed for premenopausal women whose lack of sexual desire causes distress. The condition is formally known as hypoactive sexual desire disorder, or HSDD.
"This is the biggest breakthrough in women's sexual health since the advent of 'the Pill'" for contraception, The National Consumers League said in a statement. "It validates (and) legitimizes female sexuality as an important component of health."
But Public Citizen, a consumer watchdog group that testified against the drug earlier this year, predicted that Addyi will be pulled from the market within a few years because of "serious dangers to women, with little benefit" to them. "Unfortunately, we haven't heard the last of this drug."
Sprout's drug has been nicknamed the "female Viagra" in media reports, even though it does not work like Pfizer Inc's
blockbuster Viagra pill for men that in 1998 became the first approved drug for erectile dysfunction.
The FDA had twice rejected the Raleigh, North Carolina-based firm's drug. But the latest decision comes after an advisory panel concluded in June it should be approved with strict measures in place to ensure patients are fully aware of the risks.
The news sent shares of Palatin Technologies, which is creating a rival drug for HSDD, up about 30 percent to $1.21 in extended trade.
Palatin's experimental treatment called bremelanotide is now in late-stage trials and works differently from Addyi. It attempts to activate certain brain pathways.
Palatin in a statement late Tuesday said its drug, if approved, would only be taken as needed, not on a daily basis like Addyi, thereby providing women "greater control and flexibility in their treatment."
Addyi needs to be taken every day. Unlike Viagra, which affects blood flow to the genitals, the new drug works on the brain. It is similar to a class of other drugs known as selective serotonin reuptake inhibitors, or SSRI's, that include antidepressants such as Prozac.
Women who took Addyi in a clinical study had an increase of about one sexually satisfying event (SSE) per month compared with those taking a placebo. Advocates claim that increase is meaningful. Critics say the small benefit is outweighed by the drug's risks.
Addyi will come with a prominent "boxed warning" about side effects, including among people with liver impairment or who take Addyi with alcohol or with medicines known as CYP3A4 inhibitors that include certain steroids.
Originally developed by Germany's Boehringer Ingelheim under its chemical name flibanserin, it was first rejected by the FDA in 2010 after an advisory panel said the benefits did not outweigh the risks. Sprout acquired the drug, conducted additional studies and resubmitted the application. In 2013, the FDA rejected it again.
The rejection sparked a lobbying campaign by Sprout, aided by some women's groups who accused the FDA of gender bias because it had approved Viagra for men - a charge the FDA vigorously rejected.
19th Aug 2015, 05:21 PM #2062
Re: Health Bulletin
Patients can contribute to medical studies now
To make medical research more patient-centric, top journals are now inviting reviews from people who have suffered the disease in question.
Moving away from traditional ways of publishing medical research studies, renowned journals around the world are now adding a human touch to research by introducing patients as reviewers. Studies, thus, will not just be peer reviewed by scientists doctors before publication, but also be assessed by a group of select patients who have gone through the turmoil of the disease under study .
Top journals such as British Medical Journal, Research Engagement and Involvement, and Journal of Participatory Medicine have introduced patient reviewers, thereby allowing patients to be contributors in health and medical research. "Imagine development of a chemotherapy, which is targeting the organs but is causing great discomfort to patients. As researchers we need to understand what the patients require," says paediatrician Dr Meenu Singh at PGI Chandigarh, a regular reviewer for the well-known Cochrane database of systematic reviews based in the UK.
This trend gives patients a voice and allows researchers to do studies relevant to their needs. "Patient involvement in all aspects of healthcare is to be welcomed. Of course, there would be sensible as well as terrible comments, which reflect a range of opin ions. In the end, they will go through a process of informed decision making. Reviews will also be assessed by editorial committees that will differentiate the wheat from the chaf," says Dr Vivekananda Jha, professor at department of nephrology , PGI, and deputy editor of the Indian Journal of Nephrology .
The publishers who have initiated patient reviews say they are provided a slightly different set of questions than those posed to traditional peer reviewers. Amy Price, a PhD researcher in evidencebased healthcare at Oxford, says, "An informed public working together with medical providers will forge a dynamic partnership that will potentially save many lives."
20th Aug 2015, 01:49 PM #2063
Re: Health Bulletin
Working over 8 hrs a day raises stroke risk by 33%
It's now official -working over 8 hours a day increases the risk of stroke by 33%.
Scientists have for the first time quantified the number of hours of work that could cause serious harm. Working 55 hours or more per week is linked to a 33% greater risk of stroke and a more modest (13%) increased risk of developing coronary heart disease compared with working a standard 35 to 40 hour week. The largest study till date on the issue, involving over 6,00,000 individuals will be published in The Lancet on Thursday .
It clearly shows that the longer people worked, the higher their chances of a stroke. In the study , data from 25 studies involving 6,03,838 men and women from Europe, USA and Australia were looked into, with each of them studied for nearly nine years.
The study was carried out by Mika Kivimaki, professor of epidemiology at University College London.
20th Aug 2015, 01:56 PM #2064
Re: Health Bulletin
Depressed? Go and meet friends
Upending conventional wisdom that having a depressed friend will likely make you depressed, a new study by researchers from the Universities of Manchester and Warwick has shown that it doesn't work like that. They found that a having mentally healthy friends can help someone recover from depression or even remain mentally healthy in the first place. But having depressed friends does not make you more likely to become depressed yourself.
The researchers looked at over 2,000 adolescents in a network of US high school students to see how their mood influenced each other by modelling the spread of mood using similar methods to those used to track the spread of infectious diseases. Their study is published today in the journal Proceedings of the Royal Society B.
The team found that while depression does not 'spread', having enough friends with healthy mood can halve the probability of developing, or double the probability of recovering from, depression over a 6-12 month period.
"This was a big effect that we have seen here. It could be that having a stronger social network is an effective way to treat depression. More work needs to be done but it may that we could significantly reduce the burden of depression through cheap, low-risk social interventions," said Dr Thomas House, senior lecturer in applied mathematics from the University of Manchester, and one of the authors of the study.
"We know social factors, for example living alone or having experienced abuse in childhood, influences whether someone becomes depressed. We also know that social support is important for recovery from depression, for example having people to talk to," he added.
"Our study is slightly different as it looks at the effect of being friends with people on whether you are likely to develop or recover from being depressed."
These results suggest that promotion of any friendship between adolescents can reduce depression since having depressed friends does not put them at risk, but having healthy friends is both protective and curative.
"As a society, if we enable friendships to develop among adolescents (for example providing youth clubs) each adolescent is more likely to have enough friends with healthy mood to have a protective effect. This would reduce the prevalence of depression," House said.
University of Warwick social science expert Professor Frances Griffiths and applied Mathematician Edward Hill collaborated on the study. Edward Hill said: "We've ensured that the method we used was not confounded by homophily - that's the tendency for people to be friends with others like themselves. This would have affected our research. For example if many adolescents drink a lot of alcohol and their friends drink a lot too it may be that alcoholic drink cause depression among the young people rather than who they are friends with."
20th Aug 2015, 02:04 PM #2065
Re: Health Bulletin
Coming, an oral drug to treat alcoholism
An oral drug that treats alcoholism and has very few side-effects may be available in five to six years, according to scientists, including one of Indian-origin, who have identified compounds that drastically reduced drinking in rats.
The exact causes of alcoholism are not well understood, but the urge to drink is related to the brain's pleasure centres, according to V V N Phani Babu Tiruveedhula, graduate student at the University of Wisconsin, Milwaukee. Alcohol triggers the brain to release neurochemi cal dopamine. Some drugs available to treat alcoholism are aimed at dopamine.
"They dampen out the dopamine system a little bit, so you don't get so happy when you have an alcoholic beverage," said James Cook, a chemist at the University of Wisconsin, who advises Tiruveedhula. However, these medications, derived from a class of compounds called opioid antagonists, cause depression in some patients, Cook said. They are addictive themselves, which can lead to drug abuse. Valium is an example of another common drug used to treat alcoholism that is also addictive.
Looking for an alternative, Cook focused on molecules known to cause some of the same results as Valium and the opioid antagonists with out the unwanted side effects.
Tiruveedhula has now made several promising betacarboline compounds that could represent the future of alcoholism treatment.
Cook said these potential medications could be taken orally . In tests using rats bred to crave alcohol, the scientists found that administering these compounds drastically diminished the rats' drinking. They observed very few of the side effects common to alcoholism treatment drugs, such as depression and losing the ability to experience pleasure. The drugs appeared to reduce anxiety in "alcoholic" rats, but not in control rats.
"What excites me is the compounds are orally active, and they don't cause depression like some drugs do," said Cook. The group is testing the compounds in additional animal studies. If everything works out, Cook said, a drug could be ready for the market in five to six years.
21st Aug 2015, 08:54 AM #2066
Re: Health Bulletin
Indian medicine, at 1/100th cost, saves Aussie's life
Less than four months ago, Greg Jeffery was on the verge of getting liver cirrhosis. The 61-year-old Australian, suffering from hepatitis C, desperately needed a drug called Sivoldi to reverse the life-threatening condition.
The problem was, each Sivoldi pill cost over 1,000 Australian dollars and the total treatment regime of 84 tablets would have set him back by around 100,000 dollars.
Jeffery, a historian and author, didn't have that kind of money. Desperate to source the drug at a cheaper rate, he landed in Chennai three months ago. There, he not only got the drug but bought it for less than one-tenth the price in Australia.
"The same treatment with the same drug in India is $900," Jeffery told Australian TV channel, ABC.
" Basically as soon as I got home I started taking it. Within 11 days all my liver functions had returned to normal and within four weeks there was no virus detectable in my blood — I was essentially cured," he told the channel.
Jeffery's story, now all over Australian media, has renewed the debate on whether life-saving drugs should be priced so high.
" If you haven't got the money, for a lot of people it's a death sentence — you die," Jeffery told ABC. " I was right on the edge of cirrhosis of the liver, once you get cirrhosis you then open up to tumours and cancer."
And just like the protagonist of Hollywood movie Dallas Buyers Club, Jeffery is now helping other Australians in a similar situation to source the drug from India.
" I get about 40 to 50 emails every day, seven days a week and they are from people who have hep C, whose mother or father has hep C, wife or husband has hep C," he told the channel.
The story is also a vindication of sorts for India's patent regime that is often criticized in the West for not honouring intellectual property rights in medicine.
In January this year, India's patent office rejected the patent application for Sovaldi (chemical name sofosbuvir) from US pharma giant Gilead Sciences on the ground that there was little evidence to show that " minor changes in the molecule" had substantially improved the drug.
What made the ruling possible was a controversial provision in India's law that says patent applications can be turned down if they fail to show sufficient novelty and inventive steps.
The decision opened the doors for Indian manufacturers to copy the drug and sell it cheaply. According to one report, 10 Indian companies were now making sofosbuvir. Two Hyderabad-based companies have reportedly priced their copied version at a retail price of Rs 19,900 per bottle of 28 tablets of 400 mg dosage, which is one-90th of Gilead's price.
Earlier, a study from Liverpool University had claimed that sofosbuvir could be produced for as little as $101 for a three-month treatment course.
21st Aug 2015, 09:39 AM #2067
Re: Health Bulletin
Early-stage breast condition may not require cancer cure
As many as 60,000 American women each year are told they have a very early stage of breast cancer — Stage 0, as it is commonly known — a possible precursor to what could be a deadly tumour. And almost every one of the women has either a lumpectomy or a mastectomy, and often a double mastectomy, removing a healthy breast as well.
Yet it now appears that treatment may make no difference in their outcomes. Patients with this condition had close to the same likelihood of dying of breast cancer as women in the general population, and the few who died did so despite treatment, not for lack of it, researchers reported on Thursday in JAMA Oncology.
Their conclusions were based on the most extensive collection of data ever analyzed on the condition, known as ductal carcinoma in situ, or DCIS — 100,000 women followed for 20 years. The findings are likely to fan debate about whether tens of thousands of patients are undergoing unnecessary and sometimes disfiguring treatments for premalignant conditions that are unlikely to develop into life-threatening cancers.
Diagnoses of DCIS, involving abnormal cells confined to the milk ducts of the breast, have soared in recent decades. They now account for as much as a quarter of cancer diagnoses made with mammography, as radiologists find smaller and smaller lesions. But the new data on outcomes raises provocative questions: Is DCIS cancer, a precursor to the disease or just a risk factor for some women? Is there any reason for most patients with the diagnosis to receive brutal therapies? If treatment does not make a difference, should women even be told they have the condition?
Dr Otis W Brawley, chief medical officer at the American Cancer Society, said he was not ready to abandon treatment until a large clinical trial is done that randomly assigns women to receive mastectomies, lumpectomies or no treatment for DCIS, and that shows treatment is unnecessary for most patients.
But Dr Brawley, who was not involved in the study, also said he had no doubt that treatment had been excessive.
"In medicine, we have a tendency to get too enthusiastic about a technique and overuse it," Dr Brawley said. "This has happened with the treatment of DCIS."
22nd Aug 2015, 12:25 PM #2068
Re: Health Bulletin
Banks to issue blood only on MBBS doctors' prescription
Blood banks cannot issue blood and its components on prescriptions written by ayurveda, homeopathy and unani doctors, says a circular issued by the Drugs Controller General of India (DCGI). The August 18 circular will curb the indiscriminate use of blood in treatment that has led to a rise in transfusion-related infections and deaths, it added.
It has alarmed alternative medicine practitioners. Industry insiders say Mumbai hospitals too could face hardships during emergencies since many have hired ayurveda doctors to run their wards and ICUs.
The decision to restrict prescriptions on which blood will be made available was taken "solely keeping the safety of patients in mind", Dr G N Singh, the Drugs Controller General of India, told TOI on phone. "The time has come for strict monitoring. It is important to know who is prescribing blood and how much. Our utmost goal is to see that patient safety is not compromised at any point."
Singh added that the circular was issued on the basis of a clause in the Drug and Cosmetics Act that allows blood banks only to accept prescriptions from MBBS doctors, dentists and certified veterinarians. Alternative medicine practitioners believe it will adversely affect healthcare delivery in rural areas.
The Federation of Bombay Blood Banks said all banks in the city have received the circular. "The effective implementation of this decision is something the state health ministry and Food and Drug Administration (FDA) have to decide. Whether the decision is right or wrong is not for blood banks to decide," said a member who did not wish to be quoted on the "controversial issue".
Injudicious use of blood and its components such as packed cell, plasma, platelets, etc, has recently come under BMC scrutiny too. As many as four out of 12 dengue deaths last year were attributed to over-transfusion of platelets.
Vinay Shetty of NGO Think Foundation welcomed the decision, saying even one unit of unsafe blood can pose a huge health risk to an individual. "It is imperative that blood transfusions are given only to patients who absolutely need it. Studies in the US have shown that as much as 30% of blood transfusions can be avoided," he said.
A senior technician in one of the leading blood banks said many ayurveda and homeopathy doctors often prescribe blood to raise haemoglobin levels, something that can easily be done with tablets.
The spotlight has also been turned on transfusion-related infection. The National Aids Control Organisation, in an RTI response, had revealed in January that nearly 1,000 people have contracted the human immunodeficiency (HIV) virus in Maharashtra due to transfusion of infected blood over the past five years. "Mumbai annually collects over three lakh units of blood and still grapples with the demand," said Shetty.
The alternative medicine practitioners now plan to raise the issue with the state government. "What if there is a road accident or a woman delivering in a taluka hospital? Where will you find an MBBS doctor to write a prescription," questioned Dr Bahubali Shah, president of the Homeopathy Council of Maharashtra. In Maharashtra, nearly 1.2 lakh alternative medical practitioners make up for the missing MBBS doctors.
Shah added that the government should rather design courses and train alternative medicine practitioners to identify and transfuse blood into the right patient. Singh said the dearth of MBBS doctors is a "systemic argument" that the health ministry should look into.
22nd Aug 2015, 12:40 PM #2069
Re: Health Bulletin
Dengue can affect your sight
High fever and low platelet count are not the only clinical manifestations of dengue. The mosquito-borne disease can also cause congestion in the eyes and, in rare cases, blindness.
Eye specialists say it is important to diagnose infection in dengue patients early in order to control the damage. "Eye infections in dengue patients are a known complication and are sometimes an initial symptom. We recently had a patient who lost his vision due to the infection. His eyes were swollen and tests showed he was bleeding internally. We managed to save him but could not help him get his sight back," said Dr Bhavana Chawla, additional professor of ophthalmology at AIIMS.
Last year, TOI had reported how three patients with dengue suffered partial or complete loss of vision in Mumbai.
Dr Mukesh Mehra, senior consultant, internal medicine at Max hospital, Patparganj said congestion in the eyes is seen in most dengue patients but rarely leads to blurry vision. "A 35-year-old man suffering from blurry vision due to dengue was discharged from our hospital this week," he said.
There is not enough data in India on the epidemiology of eye disease in dengue patients. However, experts say that it could range anywhere between five to six percent. In patients hospitalized with dengue, it ranges between 16% and 40.3%, which is very high.
Research published in 'Survey of Ophthalmology', a medical journal, states the time of onset of ocular symptoms can range between two days since the patient gets fever to even five months. However, in most cases, patients suffer from damage to the eyes when their platelet count drops severely.
"There is no known effective treatment for damaged retina. Active surveillance and steroid therapy are the main treatment modalities used. In some cases, the doctors have also experimented with immunosuppressive therapy to hasten clinical recovery," the journal states.
Dengue, termed by many experts as the world's most rapidly spreading mosquito-borne viral disease, follows a cyclical trend in which there is a surge in number of cases every three to five years. In the last decade, outbreaks have been reported in 2006 and 2010.
It is caused by four serotypes. While type I and III are milder in nature causing classic dengue fever and fever without shock, respectively, dengue type II and IV are considered deadly. These cause fever, bleeding and a drop in platelet count. Researchers say the presence of all four serotypes could be behind increased frequency of the disease outbreak. This year, Delhi has reported more than 280 dengue cases till date and two people have died due to the mosquito-borne disease.
22nd Aug 2015, 12:40 PM #2070
Re: Health Bulletin
Farmers spraying crops with animal hormone
Desperate to save the standing crop in the face of severe drought, paddy farmers have turned to the animal hormone Oxytocin to salvage the Khariff yield. Oxytocin, which is widely used by farmers in a bid to artificially promote growth in fruits and vegetables, has been banned for use in agriculture and animal husbandry.
According to researchers in Prof Jayashankar Telangana State Agricultural University here, paddy farmers who have lost a major portion of their standing crop due to prolonged dry spell, are testing their luck by spraying oxytocin in the fields. This is the first time that farmers are using the non-plant hormone with the hope of pumping up the growth process in paddy plants. But health experts warn that this could be catastrophic not only for paddy cultivation but also for people who consume the produce. Since oxytocin is being used for the first time in paddy, experts point out that it is difficult to predict how the hormone will react in the paddy plant.
It was only on Wednesday that the Hyderabad High Court had come down heavily on the practice of adding chemicals to artificially enhance growth of fruits. A bench headed by Acting Chief Justice Dilip B Bhosale called those responsible for such malpractices "worse than terrorists" and asked governments of the twin states to crack down on fruit-growers and sellers who use calcium carbide to ripen fruits unnaturally.
" Oxytocin should not be used in agriculture or horticulture. It is basically an animal hormone. Oxytocin, if taken in heavy dosage, may lead to nervous breakdown and even cause blood-clotting. It also causes irregular heartbeat and seizures," warned clinical dietician M Gayathri of Apollo Hospitals, Hyderguda, in the city. Even the minor side effects are severe - they include swelling of the mouth, face, lips and tongue, she added.
Contradicting farmers' notion, agricultural scientists argue that oxytocin will not promote vegetative growth. At best it can help inflorescence from withering away. " It is illegal to use oxytocin in agriculture and even in animal husbandry. It induces forced rather than natural growth. Since an animal hormone is used in a plant, we do not know what turn it will take at the genetic or molecular level. But the harmful effects are obvious," said senior researcher Dr C Srinivas of Prof Jayashankar Agricultural University.
Sources said paddy farmers, who largely depend on canal irrigation, have turned to oxytocin after 50 per cent of the standing crop had withered away. Farmers in Khammam, Warangal and Nizamabad in Telangana and Krishna, East and West Godavari, Kurnool, and Guntur districts in Andhra Pradesh are clandestinely using the banned hormone.
Agriculture scientist Dr A Kiran Kumar told TOI that the Telangana government's agriculture department has taken up campaign against the use of oxytocin. " Farmers do not approach us when they use banned or harmful chemicals. They go by the advice of private agri firms who are ready to reap a fortune by fishing in troubled waters. Since it is done secretly and without the knowledge of farm extension scientists, it is difficult to estimate the quantum of oxytocin used in paddy," he said.
The paddy ryots' desperation for oxytocin can be gauged from the fact that only 54 per cent of the normal crop area has been sown so far this Khariff in Andhra Pradesh. In case of Telangana, it is slightly better with 76 per cent of the area sown. The sowings for Khariff season 2015 officially came to an end on Thursday and any sowings from now onwards will not be viable.