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.