Friday, December 24, 2010

Monday, December 20, 2010

Shri Arun Madhavan speaks



Shri Arun Madhavan's talk at Purna Pragnya. He speaks of what the children of Purna Pragnya must feel when they leave after finishing their studies. He gives a glimpse of the fundamentally simple meaning of our life.

Tuesday, November 9, 2010

Sanofi Pasteurs dengue vaccine in ph III clinical trials

News item: Source BioSpectrum, Asia Edition




Singapore, Nov 4, 2010: Sanofi Pasteur, the vaccines division of Sanofi-aventis Group, has announced that its dengue vaccine is in final stage of clinical development. Sanofi Pasteur’s dengue vaccine, the world’s most clinically advanced dengue vaccine candidate entered its first phase III clinical study in Australia. 

This study is part of a global phase III clinical study program aimed at advancing the development of a novel vaccine for the prevention of dengue disease in children and adults. Currently, there is no specific treatment available for dengue fever, which is a threat to nearly three billion people and a public health priority in many countries of Latin America and Asia where epidemics occur. 

Phase III studies are the ultimate steps in the clinical development of a vaccine before it is submitted to regulatory authorities for evaluation for market authorization. Sanofi Pasteur’s candidate dengue vaccine is the first to reach phase III of clinical development.

“To address the global health challenge represented by dengue fever, we are conducting an unprecedented dengue vaccine research and development program as well as a scale up of the vaccine production. We are now entering the final laps of a long run that Sanofi Pasteur started almost 20 years ago. If successful, we are committed to introducing the vaccine in countries where dengue is of highest public health priority,” said Mr Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur. 

The study in Australia is the first to use dengue vaccine doses produced with industrial scale processes. The study is aimed at demonstrating that production of the vaccine at industrial scale will meet consistency criteria required for market authorization by regulatory authorities. Details of the phase III study in Australia as well as results of already completed studies are presented at the 59th annual conference of ASTMH (American Society of Tropical Medicine and Hygiene), held in Atlanta, US, on November 3-7, 2010.

Tuesday, November 2, 2010

Fentanyl transdermal pain patches recalled

After tests revealed too-rapid release of active ingredient about one million fentanyl patches for chronic pain have been recalled from store and pharmacy shelves.

Approximately one million fentanyl patches for chronic pain have been recalled from store and pharmacy shelves. The U.S. Food and Drug Administration and drug maker Actavis Inc. are working to get the word out, but they are targeting retailers and wholesalers, not consumers.

Continue reading

Thursday, September 23, 2010

FDA Restricts Use of Diabetes Drug Avandia

FDA Decides Not to Ban Avandia, but Puts Restrictions on How It’s Used.
By Daniel J. DeNoon
WebMD Health News

Sept. 23, 2010 -- The FDA will not ban Avandia -- but stringent restrictions will make it far harder for doctors to prescribe the safety-troubled diabetes drug.

The European Medicines Agency took harsher action. European sales of Avandia-containing drugs will be suspended over the next few months, although the agency did not formally withdraw approval.

The 600,000 U.S. patients currently taking Avandia can continue to take the drug only if their doctors officially attest that their patients understand the risks, that the drug is helping them, and that no other diabetes drug can keep their blood sugar under control.

New Avandia prescriptions can only be written for patients who, for medical reasons, cannot take Actos. Actos, a diabetes medication in the same class as Avandia, does not cause the heart problems linked to Avandia.

"Avandia will be available to new patients only if they cannot achieve [blood sugar] control on other agents and cannot take Actos," FDA commissioner Margaret A. Hamburg, MD, said at a news conference. "Current patients can continue taking Avandia only if they benefit and understand the risks."

Avandia maker GlaxoSmithKline will be required to establish a Risk Evaluation and Mitigation Strategy (REMS) program. Patients, their doctors, and their pharmacists will have to enroll in the program in order to receive, prescribe, or sell Avandia.

Avandia Heart Risks Clouded by Uncertainty

Hamburg admitted that FDA experts are split over how to interpret the scientific evidence suggesting that Avandia damages the heart. Both Avandia and Actos increase the risk of heart failure. But evidence suggests that only Avandia increases risk of heart attack.

Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, noted that an FDA advisory panel last July split over the issue of whether the evidence proved Avandia unsafe.

"In and outside the agency there is mostly agreement on the facts, but not on the weight of the safety analysis," Woodcock said at the news conference. "This has resulted in different conclusions, not only inside FDA but among outside experts. This reflects uncertainty in the science that tells us whether or not Avandia causes these problems."

Questions about Avandia heart safety should have been answered by the RECORD study, which Avandia maker GlaxoSmithKline conducted at the behest of the European drug agency. This study found Avandia to be safe, but critics have lambasted the study's poor design. Moreover, an FDA analysis suggests that the study failed to investigate all possible heart attacks in study patients.

Today's FDA action will require GlaxoSmithKline to convene a panel of independent scientists to review the RECORD data. That review may cause the FDA to lift the new Avandia restrictions -- or to ban the drug.

The FDA today also officially ended a study called TIDE, which was directly comparing Avandia and Actos. The FDA decided that the study, which already had been suspended, posed too much risk to participants.

In a statement, GlaxoSmithKline says it "continues to believe that Avandia is an important treatment for patients with type 2 diabetes," but that it will work with the FDA and the European Medicines Agency to implement their decisions.

Thank you, WebMD

Wednesday, September 22, 2010

Gilenya, First Oral MS Drug, Gets FDA Nod

Once-Daily Capsules Cut MS Relapses, Delay Progression
 
By Daniel J. DeNoon
WebMD Health News
 
Sept. 22, 2010 -- The FDA today approved Novartis' Gilenya, the first oral drug for multiple sclerosis (MS). Gilenya (formerly spelled Gilenia, generic name fingolimod) last June received the overwhelming approval of an FDA expert advisory panel.

Gilenya treats the relapsing form of MS. The drug significantly reduces MS attacks. However, it has serious side effects, with possible heart, lung, and eye toxicity and increased risk of infection. Patients must be closely monitored, and regular eye exams are advised.

In MS, white blood cells attack the myelin sheaths that protect nerve cells. Gilenya, the first drug in its class, keeps white blood cells penned up in lymph nodes by taking away the chemical key they need to unlock the lymph node door.

Fewer white blood cells mean fewer MS attacks. But it also means less protection against infections. Novartis will set up a careful program for educating and monitoring patients taking the drug. Moreover, the company will continue long-term studies to look for side effects that may occur with longer-term use.

Gilenya was invented as a new way to prevent rejection in kidney transplant patients. But at the necessary dosage, the drug was far too toxic. The dose that would be used to treat MS is five times lower than the lowest dose tested in the transplant studies.

Even at this dosage, Gilenya can have severe toxicity. In clinical trials, side effects linked to Gilenya included:

    * Elevated liver enzymes
    * Macular edema (swelling of the central portion of the retina, causing distorted vision)
    * Elevated blood pressure
    * Shortness of breath
    * Bronchitis
    * Diarrhea
    * Bradycardia (slowing of the heartbeat, seen only upon first treatment. The FDA panel recommended that patients be required to receive their first dose under medical supervision).

Two fatal herpes infections occurred in MS patients treated with Gilenya at 2.5 times the 0.5-milligram dose for which Novartis is seeking approval.

But overall, the drug's benefits outweighed its risks among the more than 2,600 MS patients who took the drug in clinical trials.

Sunday, August 8, 2010

How overdose of paracetamol hits kids

“Anxious mothers are feeding children excessive dosages”

“Overdose can happen more easily in children”

‘Drops' version mistaken for syrup




Even love is valuable only if it is given in the right dosage. Overdoses of drugs, specially the common paracetamol, need not be dangerous in adults, but can lead to serious complications, including liver failure, in children.

Over the past few weeks, with viral and flu infections rampant, a number of children have been admitted to the intensive care units, not for treatment of the primary illness, but for paracetamol poisoning. Janani Sankar, senior consultant, Kanchi Kamakoti CHILDS Trust Hospital, says kids come in with multi-organ failure, and while most of them could be saved, some have been beyond help as they have come too late.

“Two types of overdosing can occur: one is accidental, when the children drink up syrup because it is tasty; or two doses are taken by mistake. The other is what we are commonly seeing now: mothers with extreme anxiety feeding their children excessive dosages of paracetamol in order to bring the fever down,” Dr. Janani adds.

In a season when dengue cases are numerous, the course of the disease itself involves very high fever for several days. Mothers, in their anxiety to reduce the fever end up giving more than the recommended dosage, she says.

“In children, paracetamol overdosing can happen more easily than in adults. Doses are calibrated with body weight, and in children, even a little extra may be too much,” P. Ramachandran, director, Institute of Child Health, says. He adds that a number of private hospitals are reporting such cases increasingly.

Different values

Parents sometimes do not check the dosage of the drugs they are giving the child, as they are available in different values across different brands.

“There is the Double Strength version which they buy instead of the regular dose. With the increase in the number of dosages per day, the chances that it becomes too much for the child is high,” Rex Sargunam, senior paediatrician, explains.

Yet another complication arises because parents sometime mistake the ‘drops' version for the syrup. Deepa Hariharan, neonatologist at Sooriya Hospital says, “We had two cases recently of really sick children, where parents had bought drops instead of syrup.”

In the drops, there is 100 mg of drug in one ml while with the syrup, there is 125 mg in five ml.

“When we ask the parent to give 5 ml of the syrup four times a day, we intend a dose of 500 mg. Instead the parent buys the drops, and lands up dosing the child with 2000 mg of paracetamol,” Dr. Deepa adds.

In children, the liver is not very mature and therefore this overdose can be dangerous.

Dr. Janani cautions parents, “Do not be extraordinarily anxious and overdose the child. The paediatrician's recommended dosage must be stuck to at all times.”

Dr. Ramachandran also adds that parents and physicians should suspect and look for signs of paracetamol poisoning when a child is ill. “Initially there will be vomiting, maybe with some blood, the child will feel drowsy and will have liver damage within one to three days. Parents and physicians should watch out for this,” he says.

Laboratory tests to confirm unacceptable paracetamol levels are available and once the diagnosis is confirmed, treatment can be started at once.

This article is from The Hindu

Monday, July 5, 2010

''Dynamic Indian of the millenium"

As Member Secretary of CLINICOM, I am so thrilled to post this information here:

''Dynamic Indian of the millenium" award conferred
 
Coimbatore, Jul 4 (PTI) City-based K G Foundation today conferred the 'Dynamic Indian of the Millennium' award on Arun Madhavan, a former member of Prime Minister's special committee for model village development programme under the 20-point programme.


The award, carrying a citation, was given for his 'distinguished achievements and contribution to society over the years', the foundation chairman G Bhakthavatsalam, said at a function got up as part of the celebrations of World Doctors' Day, here.

Besides being conferred a global recognition for his 'project gateway' for promoting India as an investment destination, Arun had delivered a speech at the United Nationas, Geneva, on 'A New dimension to healthcare,' in 1996, he said. The first recipient of this award was the former president, A P J Abdul Kalam, a decade ago.


Note: The members of CLINICOM are applauding. Our best wishes are with Sri Arunji, always.

Stem cell scientists warn against fraudulent treatments


A new website will help people decide which therapies are safe and effective.
By Sandy Kleffman, Contra Costa Times

Leading scientists are warning people to beware of costly, unproven stem cell therapies that have little or no benefit and may be dangerous.

Many with devastating illnesses are mortgaging their homes and borrowing huge sums of money for treatments, which are often performed outside the United States to avoid its safety regulations.

Scientists worry that such therapies could harm people by leading to cancers and other complications.

"It's really the 21st century version of snake oil," said Dr. Arnold Kriegstein, director of the Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research at UC San Francisco.

"As soon as you scratch the surface, you realize that what they're claiming in their literature or what they tell you about, doesn't make sense," he said. "There's this notion that stem cells are in some way magic cells that can treat anything if you just deliver them into the body. That's pseudoscience and make-believe."

Stem cells have captured worldwide attention because of their ability to renew and form new cells. Scientists hope such cells can one day cure a host of deadly diseases by replacing injured and dying cells.

Of particular interest are embryonic stem cells, which can transform into virtually any cell type in the body.

But despite the encouraging signs, scientists are in the early stages of research. To date, only a handful of stem cell treatments have proven safe and effective in clinical trials. These include bone marrow transplants to treat lymphomas and leukemias, or to replace bone marrow destroyed by high doses of chemotherapy during cancer treatments.

Other well accepted therapies involve skin grafts and corneal repair.

But it can be difficult for people to determine which treatments are backed by scientific evidence. Searching the Internet for stem cell therapies will yield more than 200 companies claiming they can cure almost any condition by growing stem cells and injecting them into a patient.

"Once you read those websites and see what they are doing to people, you begin to lose faith in human nature," said Dr. Irving Weissman, director of the Stanford Institute for Stem Cell Biology and Regenerative Medicine, in a written statement. "They will take the last dollars and days of people's lives."

Weissman co-authored a report about the risks published in this week's edition of Cell Stem Cell.

The excitement surrounding stem cell research "has led to unacceptable exploitation of patients' hopes and fears," the report states.

As the immediate past president of the International Society for Stem Cell Research, Weissman convened a task force that oversaw the creation of a website to educate the public about stem cell research and to help people decide whether treatments are effective and safe.

The site, at www.closerlookatstemcells.org, recommends questions to ask before receiving a treatment.

People can also request that the stem cell society investigate a company or clinic. The society will attempt to determine whether a medical ethics committee is involved to protect patients' rights and whether the treatment will be supervised by an official regulatory body such as the U.S. Food and Drug Administration or the European Medicines Agency.

The results will be posted on the website, although it may take four or five months to complete the review.

In addition to protecting the public, stem cell researchers want to avoid having the fraudulent clinics cast a shadow over stem cell research or cause the public to question legitimate breakthroughs.

Scientists still have much to learn about stem cells, including how to ensure that embryonic stem cells transform into a specific cell type.

Worrisome results
One big concern is that stem cells will start producing tumors or cancers during untested treatments, Kriegstein said.

He noted that this happened with a boy in Moscow who developed tumors in his central nervous system as a result of a therapy.

Another worry is that a patient's body could reject the stem cells.

"These cells usually come from one or more donors that are not related to the patient and haven't been in any way matched, so they run the risk of having immune responses that could be significant," Kriegstein said.

It can be risky even to use a patient's own stem cells, the website notes. After the cells are removed from the body, they could become contaminated with bacteria or viruses that cause diseases when they are injected back into the body. If they are grown in a culture, they may lose the normal mechanisms that control growth or may lose the ability to specialize into the cell types the patient needs

Kriegstein said he understands that patients who seek such treatments often have no options. But because of the problems, he said, "I think going to these places is worse than having no treatment at all."

Among the suggested questions for people to ask is the source of the stem cells and how they are isolated and grown.

"Be wary of clinics that offer treatments with stem cells that originate from a part of the body that is different from the part being treated," the website notes. Stem cells from bone marrow regenerate blood, for example, but cannot make brain cells.

Kriegstein urges people to question how stem cells will be delivered to the right part of the body. Stem cells injected into one area may not make it to the area that needs repair, "let alone actually do something once they get there," he said.

Breakthroughs expected

Despite such cautions, Kriegstein and others are convinced the future is bright for stem cell research. Companies and scientists in the Bay Area and elsewhere are striving for scientific breakthroughs and are increasing their knowledge about how such cells work.

The first embryonic stem cell treatment for acute spinal cord injury is under review by the FDA and may soon move into clinical trials.

And in February, the British company ReNeuron announced it had been approved for a clinical trial of a stem cell treatment for strokes.

"We and others around the world are working very hard, as quickly as we can, to test therapies and develop new approaches," Kriegstein said.

"Eventually, I have complete faith that there will be therapies available that will come out of the current research that's going on in stem cell biology, but it will take time," he said. "There are certain disease areas where it may happen sooner than others. But the potential of stem cells is certainly there."

Questions to ask

The International Society for Stem Cell Research has set up a website to help people decide if treatments are effective and safe, at www.closerlookatstemcells.org People can ask the society to review a clinic, although it may take four to five months for a response.

Here are some questions for patients to ask: 
  • What is the source of the stem cells? How are they isolated and grown?
  • How are the cells delivered to the right part of the body?
  • How will my immune system be prevented from rejecting these cells?
  • What is the scientific evidence that this could work for my disease or condition?
  • What are the risks?
  • Is a medical ethics committee involved?
  • Is there supervision by a regulatory body such as the U.S. Food and Drug Administration or European Medicines Agency?
Source: International Society for Stem Cell Research

Thursday, July 1, 2010

Smoking parents = fat, bad kids

 

Two new studies suggest there's a connection between parents who smoke and kids who are heavier or misbehave more than other children.

The researchers haven't definitively proven that lighting up puts kids at risk for bad behaviour and extra pounds. In fact, it may be impossible to ever prove a cause-and-effect because it's considered unethical to assign some parents to smoke and then see what happens.

Still, the findings "tighten the link" between parents who smoke and physical and mental health problems in their kids, said Dr Jonathan Winickoff, an associate professor of pediatrics at Massachusetts General Hospital, who co-wrote a commentary accompanying the research.

For decades, doctors have advised pregnant women to avoid smoking for fear that they would harm their unborn children; research has linked smoking in mothers to physical problems in offspring such as low birth weight. If the mother smokes during the first trimester, the effects are worse than in later trimesters, said Neil E. Grunberg, a professor of medical and clinical psychology at the Uniformed Services University of the Health Sciences, in Bethesda, Md.

But it hasn't been as clear whether there's a connection between mothers who smoke and other health problems in their kids. And the influence of fathers who smoke - exposing their kids to secondhand smoke or perhaps affecting sperm at conception - has also remained a mystery.

The study

In one of the new studies, researchers examined what happened to kids whose fathers smoked but their mothers did not. Researchers from the University of Hong Kong studied 7,924 kids from that region who were born in 1997.

The researchers found that the kids who had fathers who smoked were more likely to be heavier at ages seven or 11 after the statistics were adjusted so they wouldn't be thrown off by factors such as gender and socioeconomic status.

The study appears in the July print issue of Paediatrics, as does a study linking pregnant mothers who smoke to misbehaving kids.

The second study

In that second study, British and Brazilian researchers studied 509 children in Brazil and 6 735 in England. After adjusting their statistics to account for possible confounding factors, they discovered that kids of mothers who smoked while pregnant were more likely to be deemed aggressive and disruptive.

This isn't the first time researchers have come to this conclusion, said Grunberg. And if smoking does cause the problems, the study doesn't say how, he added.

So, what might be the connection between parents who puff cigarettes and kids who misbehave and weigh more than others?

Winickoff, co-author of the commentary, said it's not true that smoking makes people skinnier. Instead, it boosts the weight around their bellies and hips, he explained. One theory is that secondhand smoke could do the same thing to those who are exposed, like the kids of dads who light up.

As for pregnant mothers who smoke, their bodies don't act as filters, he said. Instead, the toxins from smoking affect the foetus.

"Anyone who's been in the delivery room when a mother who smokes cigarettes delivers can attest to the state of the placenta," he explained. "In general, it's withered, discoloured. It's very clear that the blood supply to the child is compromised." - (HealthDay News, June 2010)



Rosiglitazone - increased risk of myocardial infarction?

NEW YORK (Reuters Health) - Two reports today in two separate journals -- a meta-analysis and a large retrospective study -- provide more evidence linking the thiazolidinedione rosiglitazone to an increased risk of myocardial infarction (MI).

The retrospective study also ties rosiglitazone therapy to an increased risk of stroke, heart failure, and death from any cause in patients aged 65 and older.

In an e-mail to Reuters Health, Dr. Steven E. Nissen, chair of the Department of Cardiovascular Medicine at The Cleveland Clinic and a long-time vocal critic of rosiglitazone, said the two manuscripts "provide overwhelming evidence of the hazards" of the drug.

"Taken together," he wrote, "the two studies demonstrate that this drug has an adverse benefit risk relationship and should be removed from the market. I would advise physicians who are still using rosiglitazone to stop and begin switching their patients to safer alternatives, including pioglitazone."

Concern over the effects of rosiglitazone on the heart arose in 2007 after Dr. Nissen and colleagues published a meta-analysis that showed a significantly elevated risk of MI and a borderline significant increased risk of cardiovascular death with its use.

Today, in the Archives of Internal Medicine, Dr. Nissen and co-author Kathy Wolski, also of the Cleveland Clinic, report results of an updated meta-analysis of 56 randomized controlled trials published through February 2010. These trials lasted at least 24 weeks and included a total of 35,531 patients; 19,509 received rosiglitazone and 16,022 received comparator drugs or placebo. (The journal has made the full text of the article available for free; the link appears below.)

There was no evidence from the updated meta-analysis that rosiglitazone increases the risk of cardiovascular deaths or all-cause mortality.

However, the authors estimate there is a 28% to 39% increased risk of MI with rosiglitazone, with a number needed to harm of 52 with RECORD trial data included and 37 without this trial. (Low event rates in the open-label, noninferiority RECORD trial of rosiglitazone published in 2009 resulted in insufficient statistical power to confirm or refute evidence of increased risk for MI).

Subgroups classified by study length and comparator drug used also showed elevated risks with rosiglitazone. "These findings are consistent with prior meta-analyses conducted by GSK (GlaxoSmithKline), the FDA, and most independent investigators demonstrating an increased risk of MI in patients treated with rosiglitazone," Dr. Nissen and Ms. Wolski note in their report.

"Because no unique benefits of rosiglitazone use have been identified," they add, "administration of this agent solely to lower blood glucose levels is difficult to justify."

The second paper, published in the Journal of the American Medical Association by Dr. David J. Graham, of the FDA's Center for Drug Evaluation and Research in Silver Spring, Maryland, and colleagues, reports the results of a large US cohort study examining the risk of cardiovascular events in 227,571 patients aged 65 and older. These patients initiated treatment with either rosiglitazone or pioglitazone between 2006 and 2009 and were followed for up to three years. (This paper too is available online at no charge from the journal; the link appears below.)

There were 8,667 events during the study period. Compared with pioglitazone, rosiglitazone was associated with an increased risk of adverse cardiovascular events, including heart failure (odds ratio, 1.25), stroke (OR, 1.27), death (OR, 1.14), and the composite of acute MI, stroke, heart failure or death (OR, 1.18).

Notably, the authors say the attributable risk for the composite endpoint was 1.68 and the number needed to harm was 60 treated for 1 year.

"The Graham study is well done and large," Dr. David N. Juurlink, author of an editorial in JAMA, told Reuters Health by e-mail, "and it adds to the evidence that rosiglitazone is less safe than pioglitazone."

"I think that was pretty clear before the Graham paper, but this new study throws another log on the fire at the feet of the FDA," added Dr. Juurlink, of Sunnybrook Health Sciences Center, Toronto, Canada.

The US FDA will hold an advisory committee meeting in July to consider whether to remove rosiglitazone from the market.

Reference
http://archinte.ama-assn.org/cgi/content/full/2010.207 http://jama.ama-assn.org/cgi/content/full/jama.2010.920 http://jama.ama-assn.org/cgi/content/full/jama.2010.954

Arch Intern Med 2010.
JAMA 2010.