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Friday, September 19, 2008

Why chemo works for some people and not others...

MIT researchers have shown that cells from different people don't all react the same way when exposed to the same DNA-damaging agent — a finding that could help clinicians predict how patients will respond to chemotherapy.

The research team from MIT's Center for Environmental Health Sciences (CEHS) and the Departments of Biological Engineering and Biology, identified a group of 48 genes that can predict how susceptible an individual is to the toxic compound, known as MNNG. The work appears in the Sept. 19 online edition of Genes and Development.

MNNG, a DNA-damaging compound similar to toxic chemicals found in tobacco smoke and in common chemotherapy agents, usually kills cells by inducing irreparable DNA damage. However, the researchers found a wide range of susceptibility among cells taken from healthy people.

"A cell line from one person would be killed dramatically, while that from another person was resistant to exposure," said Rebecca Fry, former MIT research scientist and lead author of the paper. "It wasn't known that cell lines from different people could have such dramatic differences in responses."

Toxic agents such as MNNG create lesions in DNA, provoking the cell to defend itself with a variety of DNA-repair and other pathways. However, every individual expresses slight differences in the genes involved in those pathways.

"Even if everyone is exposed to exactly the same things, they would respond differently, because we're all genetically different," said Leona Samson, senior author of the paper, director of CEHS, and an American Cancer Society Research Professor.

The team members found that after measuring the expression of every gene in each cell line, they could predict cell sensitivity to MNNG from the expression of just 48 specific genes, with 94 percent accuracy.

Several of those 48 genes have already been linked to cancer, said Samson, but it was not known that their expression is already altered before exposure to the DNA damaging agent.

Source: The Hindu

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Saturday, September 13, 2008

Tiny 'ships' kill tumour in bloodstream...

Tiny ships loaded with a cargo that can identify and destroy cancerous tumours are being tested on mice and could one day ply the human bloodstream.

"These mother ships are only 50 nanometers in diameter, or 1,000 times smaller than the diameter of a human hair, and are equipped with an array of molecules on their surfaces that enable them to find and penetrate tumour cells in the body," explained biochemist Michael Sailor at the University of California, San Diego.

The hulls of the ships are created with specially modified lipids (a type of energy-storing fat) designed to mimic lipids that cover natural cells, allowing the ships to avoid the radar body's immune system. The stealth construction was tested on mice, and the ships sailed for hours before being destroyed.

The ships were loaded with an anti-cancer drug plus superparamagnetic iron oxide and fluorescent quantum dots. The iron oxide nanoparticles allow the ships to show up in a Magnetic Resonance Imaging, or MRI, scan, while the quantum dots can be seen by a fluorescence scanner.

"One can imagine a surgeon identifying the specific location of a tumour in the body before surgery with an MRI scan, then using fluorescence imaging to find and remove all parts of the tumour during the operation," Sailor said.

Source: The Times of India

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Monday, September 8, 2008

Stephen Colbert's DNA to back up the human race...

Should anything happen to Earth, the human race will now be insured.

Comedy Central announced Monday that the host of The Colbert Report will have his DNA digitized and sent to the International Space Station (ISS). According to the Associated Press, Stephen Colbert's gene package will be carried there by famed video game designer Richard Garriott, who will travel to the station in October.

Garriott will deposit the "Immortality Drive," a time capsule that will include human DNA and records of humanity's greatest accomplishments, along with personal messages collected specifically for the project.

This will be the second time Colbert goes intergalactic. In May, May he was the first late-night host to interview an astronaut, Garrett Reisman, while he was in space.

In a statement, Stephen Colbert said he was thrilled to have his DNA shot into space, as this would bring him "...one step closer to my lifelong dream of being the baby at the end of 2001," referring to the 1968 sci-fi movie 2001: A Space Odyssey.

In a statement, Garriott said: "In the unlikely event that Earth and humanity are destroyed, mankind can be resurrected with Stephen Colbert's DNA. Is there a better person for us to turn to for this high-level responsibility?"

Stephen Colbert's answer to that rhetorical question would probably be "no."

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Sunday, September 7, 2008

Natural Medicine: Probiotics -- The "good" bacteria...

The human digestive tract is home to billions of bacteria, and many are essential for normal digestion. Probiotics are one of the friendly bacteria that help maintain and establish a healthy intestinal tract.

The many benefits of probiotics include:

  • Inhibit the growth of harmful bacteria, viruses and yeast
  • Improve digestion and absorption of nutrients
  • Decrease lactose intolerance
  • Support immune system
  • Decrease prevalence of food allergies and sensitivities
  • Decrease the risk of certain cancers
  • Decrease the incidence of diarrhea and constipation

    Some popular foods high in probiotics include yogurt containing active cultures, and fermented foods such as tempeh and miso. However, it is key to read product labels before purchasing probiotic-rich foods because different brands can vary greatly in their bacteria strain and potency. The most common species of probiotics found in food and supplements are called lactobacillus and bifidobacterium.

    There are many easy ways to bring probiotics into your diet any time of day. Try adding yogurt to your morning cereal, or freezing it for a healthy dessert or snack. Add tempeh to a stir-fry, soup or stew and use fermented vegetables such as sauerkraut and kimchi as a zesty side dish or condiment. Miso soup traditionally is served as a breakfast dish in Japan, but it makes a great addition to any meal and is an excellent way to warm up on a cool, cloudy day.

    Schedule an appointment with a licensed nutritionist to learn more about how a diet rich in probiotics may benefit your health.

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    Tuesday, September 2, 2008

    New England Journal of Medicine: Vytorin-Cancer Link ‘Uncertain’...

    The medical community shouldn’t rush to dismiss a possible link between Vytorin and cancer, the New England Journal of Medicine says in an editorial this morning.

    The editorial appears alongside the results of a study in which patients who took the drug were more likely to develop cancer than those who took placebo. Also appearing in this morning’s NEJM is an analysis that looked at the new study along with two other, larger studies, and concluded that the data “do not provide credible evidence” that Vytorin raises the risk of cancer.

    The basic findings of the study and the analysis were released in July. Vytorin, which is co-marketed by Merck and Schering-Plough, is actually a combination of two drugs: a statin called simvastatin, and a second cholesterol-lowering drug called ezetimibe, sold alone under the brand name Zetia.

    The NEJM editorial noted that the analysis of multiple Vytorin studies found that the drugs didn’t increase the risk of cancer, but did show a slight increase in cancer deaths. The analysis concluded that the increase is simply a fluke.

    But while future research may confirm that Vytorin doesn’t raise the risk of cancer deaths, the editorial said, “it is appropriate to raise a note of caution. Whether the increased mortality risk is due solely to the play of chance is uncertain. … Physicians and patients are unfortunately left for now with uncertainty about the efficacy and safety of the drug.”

    The data are being presented today at a big cardiology conference in Munich. For more on on the controversy surrounding Vytorin see the New York Times front-page story in the paper’s series on evidence gaps in the practice of medicine.

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    Monday, September 1, 2008

    Patients with coronary artery may not benefit from vitamin B supplements...

    According to a study by Marta Ebbing, lead researcher and M.D. of Haukeland University Hospital, Bergen, Norway patients suffering from coronary artery diseases and generally prescribed vitamin B supplements to reduce death risk may not benefit as previously thought.

    For the study 4 groups were created and the 3096 patients from two Norwegian hospitals were selected for the study. The participants were then randomly assigned to any of the 4 group. There were 2462 males and 634 females with average age of 61 years. The study was conducted between 1999 and 2006.

    The first groups were given daily dose (oral) of vitamin B12, B6 and folic acid. The second group was subjected to vitamin B12 and folic acid. The third group was given oral doses of vitamin B6 only, and fourth group received placebo alone.

    The study revealed that the groups that received vitamin B12 and folic acid for about a year showed 30 % reduction in mean plasma total homocysteine concentration.

    According to researchers 422 participants of which 219 from group two and four reached the end point in the study. By definition “The primary end point was a composite of all-cause death, nonfatal acute myocardial infarction, acute hospitalization for unstable angina pectoris, and nonfatal thromboembolic stroke.”

    200 participants who were subjected to vitamin B6 benefited from the treatment as compare to the 222 who did not receive such treatment. The groups that were given folic acid showed lower stroke incidents but higher cancer incidences.

    Over all the study indicated that prescribing vitamin B for patients with coronary artery disease does not serve the purpose.

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    Saturday, August 30, 2008

    Conference combines music with medicine...

    The Fort Wayne area is known in some regional circles for its music and its medicine, but not so much for the kind of out-of-the-box thinking that could advance efforts to combine the two for patient treatment or wellness promotion.

    That could change at a Sept. 12-13 conference at Indiana University-Purdue University Fort Wayne.

    The university will be the site of the third-annual international conference organized by the Alliance for Research in Music Medicine. General admission for the conference is $75 and includes dinner.

    The alliance is expecting a diverse group of 75 to 100, “but it’s very hard to say,” said Nancy Jackson, director of music therapy at IPFW. “It’s Indiana, and this is very new to Indiana folks. But it started here, so it should come home here.”

    The conference’s theme this year is “Music and Medicine: Composing the Science of Healing.” Author and physicist Claude Swanson will keynote the event, kicking it off with a view of quantum physics that will take the audience on a musical journey into the body’s physiology and biochemistry.

    An alliance statement on the conference said its presentations and panel discussions will share the latest research on music’s impact on chronic disease, inflammation and new treatment strategies.

    Questions and ideas relating to sound and body frequencies will be among the more intriguing topics covered at the conference, Jackson said.

    “We know that all matter vibrates. All matter has some sort of frequency to it, and the cells of our body certainly are included in that,” she said.

    “With the appropriate technology, we can probably have a computer picture of what those frequencies in the body are. We know lots of pieces and those pieces just have to be brought together.”

    Speakers at the conference who aren’t medical doctors all have Ph.D.s. “If you look at the lineup, we have a very diverse group of people, all with very excellent credentials,” Jackson said.

    “It’s not about one person or one viewpoint being the authority. We are all bringing our own expertise in to look at our common problems,” she said. “We’re looking at ways we can start to do research together and not have missing pieces in the studies we have done.”

    ARIMM was co-founded by Jackson and a local doctor who chairs its board, Angela LaSalle of Fort Wayne Endocrinology.

    LaSalle had graduated from IPFW, and when she had the idea for the conference, she contacted Jackson about it because she remembered the university had a music therapy program.

    The first ARIMM conference took place at the University of Arizona through contacts LaSalle had developed when she was there for its integrated medicine program. This year, the conference is hosted and co-sponsored and by IPFW’s Music Department.

    “We expect some students here and we expect some professionals here. There are people in the community who are very interested,” Jackson said.

    “We’re going to have folks who are just intrigued and professionals who really want to get involved in this. We need lots and lots of ideas and viewpoints.”

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    National Library of Medicine (NLM) at the National Institute of Health (NIH) has accepted Journal of...

    National Library of Medicine (NLM) at the National Institute of Health (NIH) has accepted Journal of Visualized Experiments (JoVE) for indexing in the official repositories of the scientific literature MEDLINE and PubMed.

    Less than 2 years old, JoVE is a new type of scientific journal that publishes online video-demonstrations of biological experiments as performed in laboratories of leading academic institutions including Harvard, MIT, Stanford and Berkeley. Now it became the first video journal to be indexed by NLM. The decision was made by the NLM advisory committee, Literature Selection Technical Review Committee, which is composed of the authorities in the field of biomedicine, such as researchers, physicians, editors, health science librarians and historians. This committee evaluates the scientific quality of publications and typically approves only 25% of the applications.

    Dr. Moshe Pritsker, the CEO of JoVE, emphasized the importance of this decision. “Inclusion in PubMed/MEDLINE is a big milestone for JoVE, and for the scientific publishing in general. It provides the official recognition and "blessing" of the scientific community to the new approaches in science communication. Overall, this decision will encourage biological scientists to publish their experiments using video online to increase efficiency and transparency of their research, which are critical “bottleneck” problems in the life sciences today.”

    According to Dr. David Crotty, the Executive Editor of the scientific publication CSH Protocols, “It's exciting to see JoVE accepted into MEDLINE/PubMed. New technologies are allowing scientists to share information in new ways and JoVE is doing groundbreaking work in establishing visual explanations as a legitimate means of scientific publication. Indexing by MEDLINE/PubMed means it will be easier for researchers to find JoVE's video articles, and will hopefully help pave the way for mainstream acceptance of some of these new communication methods.”

    Ike Burke, Director for Production at the scientific publisher Annual Reviews, said:
    “We think users of our in-depth literature reviews benefit immensely when relevant experimental-protocols can be demonstrated and explained in article-accompanying videos. We’ve sponsored JoVE’s collaboration with our authors in the production of such videos because JoVE offers a superb grasp of the science involved, sensitivity to our authors’ busy schedules, and professional mastery of videographic narrative. We applaud the National Library of Medicine evaluators for extending to JoVE this well-deserved (and indispensable) recognition.”

    About Journal of Visualized Experiments (JoVE); www.jove.com
    JoVE was founded in October 2006 as the first online video-publication for biological research to increase transparency and efficiency in biological sciences. The JoVE editorial board includes 20 scientists from leading academic institutions including Harvard, Princeton and NIH. JoVE has released 17 monthly issues including over 200 video-protocols on experimental approaches in neuroscience, immunology, developmental biology, microbiology and other fields. To facilitate integration of video into scientific publishing, JoVE has developed an organizational and technological structure to conduct production of scientific videos in research labs in the USA, Europe and Japan.

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    Herbal medicine all-clear...

    AYURVEDIC centres in Bahrain claim their customers have nothing to fear after US researchers found harmful levels of lead, mercury and arsenic in Ayurvedic medicines purchased over the Internet.

    Researchers at the Boston University School of Medicine (BUSM) discovered one-fifth of US and Indian-manufactured Ayurvedic medicines they purchased online contained enough of the dangerous substances to exceed acceptable standards.

    Their findings have been published in the Journal of the American Medical Association (JAMA) and have raised question marks over the safety of Ayurvedic remedies here.

    "Herbs and supplements with high levels of lead, mercury and arsenic should not be available for sale on the Internet or elsewhere," said Dr Robert Saper, who led the study.

    "We suggest strictly-enforced, government mandated daily dose limits for toxic metals in all dietary supplements, and requirements that all manufacturers demonstrate compliance through independent third-party testing."

    Ayurveda is a form of medicine based on herbal products that originated in India more than 2,000 years ago.

    The alternative treatment has recently gained popularity in the Gulf among all nationals, with several centres now operating in Bahrain.

    However, Kottakkal Ayurvedic Centre manager S Shekhar told the GDN that such medicines available in Bahrain had to undergo testing by the Health Ministry before they could be sold.

    He added that imported Ayurvedic medicines found to contain unacceptable quantities of the metals were shipped back to India.

    "We use and sell only those medicines that are allowed in Bahrain and have a valid licence to do so," said Mr Shekhar.

    "We get our shipment of medicines from our headquarters in India once every two months.

    "These medicines are subjected to various tests by the Health Ministry, like heavy metal residue test, microbiological residue test and pesticide residue test.

    "However, since testing each item costs around BD50 to BD55, they are only tested once (for the first time) and later they are only tested randomly.

    "But when sometimes it was found (during testing) that the item contained these metals in unacceptable quantities or that certain herbs were not allowed for sale here, they were sent back.

    "This is applicable to all alternative medical centres in Bahrain licensed to import medicines, so there's nothing for Bahrain to worry about."

    Meanwhile, Coimbatore Herbal Centre senior specialist Dr Rajeev Raj said medicines manufactured using metals were not harmful if they were properly processed.

    "Ayurvedic medicines are divided into two major types: herbal only and Rasa Shastra, which is an ancient practice of deliberately combining herbs with metals, minerals and gems," he said.

    "If medicines made with lead, mercury and arsenic are properly prepared and administered, they will be safe and therapeutic.

    "They need to undergo various thorough processes until they are converted from being inorganic to organic.

    "They should be in a form that can be assimilated by the human body, but if otherwise consumed they will prove to be highly poisonous.

    "We get our medicines from other centres in Bahrain that are licensed to sell them."

    Bahrain Wellness Resort Centre medical officer Dr Janaki Balan admitted that medicines still retaining unacceptable quantities of the metals could lead to serious health problems.

    "Our shipment of medicines comes from Kerala once every six months, which we use for treatment and selling," she said.

    "If our medicines contain anything at all harmful or not approved by the Bahraini government, we will not be able to use them.

    "Medicines that contain lead, mercury or arsenic in quantities that are not acceptable would affect the human organs."

    However, despite the comments of his counterparts who appear to support the US study, Madawi Integrated Medical Complex chief executive officer V S Thampi denied that Ayurvedic medicine could be harmful.

    He even claimed the report was a politically-motivated attempt by the US to damage India's reputation.

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    Thursday, August 28, 2008

    Gene therapy 'may repair hearing'...

    The ear gradually loses hair cells

    Gene therapy has the potential to restore hearing in mice, offering hope for humans too, US scientists suggest.

    An Oregon team discovered gene transfer produced functioning hair cells that are essential for the inner ear to interpret sounds, Nature reports.

    In people with normal hearing, cochlear hair cells convert sound into electrical signals, which are ultimately transmitted to the brain.

    Once the cells are lost or damaged, they cannot be replaced naturally.

    Although still a long way from the clinic, the work shows that gene therapy is a potential treatment to combat some forms of congenital deafness
    Professor Andy Forge
    Deafness Research UK

    According to the Royal National Institute for Deaf People (RNID), there are about nine million people who are deaf or hard of hearing in the UK.

    Most of them have lost their hearing gradually with increasing age, partly due to the loss of hair cells in the cochlea.

    Repair and replace

    Prolonged exposure to loud noise is another culprit, damaging the hair cells.

    John Brigande and his team from Oregon Health and Science University showed, at least in unborn mice, gene therapy can be used to encourage other cells to become hair cells.

    Gene therapy uses a harmless virus to insert copies of the key gene into cells which then replicate.

    The key gene used by the Oregon team was Atoh1 which is essential for hair cell development.

    The cells "treated" with Atoh1 functioned exactly like original hair cells.

    "This capability is a crucial first step in defining translational therapies to ameliorate the effects of inner-ear disease in humans," the researchers said.

    Work in humans is still a way off, but the findings point to a way to repair the damaged cochlea without using a mechanical or electrical device.

    Currently, people can have a cochlear implant which works by bypassing the damaged cochlear hair cells and stimulating the auditory nerve directly.

    An implant cannot restore hearing to normal but it does give the sensation of sounds.

    Andy Forge, Professor of Auditory Cell Biology and advisor to Deafness Research UK, said: "Although still a long way from the clinic, the work shows that gene therapy is a potential treatment to combat some forms of congenital deafness.

    "With one in 2,000 children born deaf because of genetic defects, such a therapy would clearly be of value."

    Dr Mark Downs, of the RNID, said: "This is an exciting development which completes another important piece of the jig-saw in understanding how we might use gene therapy to eventually restore hearing loss."

    Source: BBC News

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    Young children 'almost completely selfish'...

    Parents who attempt to ingrain egalitarian ideas among very young children are bound to feel frustrated, for a research suggests that kids become more egalitarian only as they grow older.

    According to a study by Swiss scientists, children learn the principles of equality by the age of eight. The study, which is published in the latest August issue of online journal Nature, showed that majority of three and four-year-olds are inherently selfish. However, by the age of seven, most have acquired the ability to consider other peoples feelings.

    "At age three to four, the overwhelming majority of children behave selfishly, whereas most children at age seven-eight prefer resource allocations that remove advantageous or disadvantageous inequality," says Dr Ernst Fehr, who led the research at the University of Zurich. At the age of three, children were "almost completely selfish", says Fehr.

    When Scientists asked 229 Swiss schoolchildren to share packets of sweets with another child of the same age, they found that three and four-year-olds rarely gave their partners any sweets. Fewer than 10 per cent of them shared the sweets equally, the research found.

    However, when the same experiment was carried out with seven and eight-year-olds, Scientists came across dramatic change. Most children routinely chose the fairest options.

    Source: The Hindu

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    Drugs used in clinical trials safe: AIIMS...

    Under fire over the death of 49 children during clinical trials, AIIMS on Tuesday said the drugs used in the tests were found "safe" and that the children were not selected from a particular socio-economic group. Noting that the drugs used in the trials were found safe in earlier studies and "not known" to have fatal complications, the country's premier health institute said the deaths occurred as the children had "high risk and serious disease conditions".

    "All studies had undergone scientific scrutiny and had all the required regulatory and ethical approvals," AIIMS said in a statement here. The statement came following a controversy over the reports of deaths of 49 children during clinical trials of new medicines in the premier institute during the last two-and -a-half years.

    Refuting allegations that children who underwent the tests were from a poor socio-economic background, the AIIMS said the children enrolled for the trials represented the "prevailing mix" of patients treated at the premier institute. "There was no question of targeting any socio-economic group selectively," the statement said, adding that AIIMS would share all details on the issue upon the completion of the in-depth enquiry ordered by the Union Health Ministry.

    Defending the trials, the AIIMS said that no death was "attributable to the study treatments used" as all children received the standard treatment and no medication or supportive care required for underlying condition withheld. "The deaths were due to the natural history of the severe disease that the children suffered from," the statement said adding the children selected for the trials had ailments like sepis and those with respiratory failure receiving life support.

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    Wednesday, August 27, 2008

    Novavax Moves Closer to Licensing Bird Flu Vaccine...

    Novavax said yesterday in Washington that its bird flu vaccine elicited a robust immune response in humans, moving the biotech a step closer to licensing its pandemic vaccine production system.

    In the trial, 160 patients received two vaccine injections, of 15 to 90 micrograms, one month apart. Of the patients who received the highest dosage, 94 percent produced antibodies to neutralize H5N1, an Indonesian strain of bird flu that emerged in 2005 and has been linked to 110 deaths.

    "These results are strong and very competitive," said Rahul Singhvi, Novavax's chief executive.

    Shares of Novavax fell 6 cents, or 2 percent, to $2.91.

    Novavax has had a demo of the vaccine manufacturing process set up at its Rockville headquarters since May 1 but does not have a buyer.

    There were 385 cases of bird flu in humans, leading to 243 deaths, from 2003 to June 19, according to the World Health Organization's most recent data. Outbreaks have mostly centered on Asia.

    Many large multinational biotechs -- GlaxoSmithKline, Sanofi-Aventis, Novartis -- are working on bird flu vaccines in the United States and Western Europe under government contract, said Ken Trbovich, an analyst with RBC Capital Markets.

    Novavax has partnered with GE Healthcare to reach the rest of the world by providing other countries a system to quickly mass-produce vaccines.

    "If you truly believe a pandemic outbreak is likely, there is reason to believe foreign governments and the U.S. will clamp down and control the supply," Trbovich said. He added, "Other places in the world may have a lot of money, but no amount of money will get you vaccines in the case of a pandemic."

    Traditionally, to create flu vaccines, drugmakers grow live virus strains in chicken eggs, which act as incubators. The virus is later killed and bottled into a vaccine. But eggs are a volatile medium, and a scarce supply essentially stops production.

    Novavax's bird flu vaccine uses particles that mimic the size and shape of the virus, which trigger an immune response but lack the genetic material to replicate.

    Because the particles are produced in more stable insect-cell cultures, yields are seven to 10 times higher than egg-based manufacturing, Novavax said. The vaccine can also be created within 10 to 12 weeks of identifying a pandemic strain -- half the time it takes to make egg-based vaccines.

    GE is developing the production equipment, which is cheap to set up and run in case of a pandemic.

    In December, Novavax studied low doses of its bird flu vaccine in a much smaller patient population. After tweaking the production process, the biotech was able to elicit a stronger immune response in this recent trial.

    Novavax is seeking a governmental or pharmaceutical partner to finance the next set of human trials.

    "We see no reason to invest additional money of our own into the pandemic vaccine when we can wait for a foreign government that needs this vaccine to put money in," Singhvi said.

    Meanwhile, Novavax will be begin human tests of its seasonal influenza vaccine, using virus-like particles, in the fall. Currently all U.S. flu vaccines are egg-based.

    "The pandemic area is difficult to monetize even if you successfully generate a contract," Trbovich said. "There are no reoccurring revenues. Moving a seasonal flu vaccine into clinical trials is their first real commercial opportunity."

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    Tuesday, August 19, 2008

    Repeat Ultrasounds Predict Heart Risk...

    Repeat examinations using ultrasound could help identify patients at high risk of having strokes or heart attacks, according to a new study.

    Researchers from Austria performed ultrasound exams of the carotid arteries, the vessels in the neck that supply the brain with blood, and then repeated the exams six to nine months later to see if they could predict which patients were at high risk of a heart attack or stroke.

    They zeroed in on changes in plaque -- the buildup of fat, cholesterol, and other substances that can narrow blood vessels. The researchers found that patients whose plaque appeared unstable were more likely to have a heart attack or stroke during the three-year follow-up.

    About 600,000 Americans have a new or first stroke each year, according to American Heart Association estimates, and another 600,000 have a first heart attack. The attacks often come without apparent warning, as in the case of NBC newsman Tim Russert, who died June 13 of a heart attack after plaque ruptured in an artery, according to his doctor.

    Tracking Plaque

    For years, physicians have performed ultrasound exams of arteries in high-risk patients to determine how much the plaque has caused a narrowing in the blood vessels, called stenosis.

    But "the determination of the degree of stenosis alone is insufficient to predict patients' risk," says Markus Reiter, MD, a physician at Medical University of Vienna, and the study's lead author. That is because a significant number of heart attacks and strokes occur in those whose blood vessels may not be extremely narrowed.

    So Reiter's team zeroed in on patients who did not have symptoms of heart attack or stroke but were known to be at high risk for such problems. They gave them two ultrasound exams to analyze in detail the type of plaque they had, and then followed the plaque over time to see if they could predict which patients were more likely to have a cardiovascular crisis.

    Repeat Ultrasounds to Predict Heart, Stroke Risk

    Reiter's team first did ultrasound exams of the carotid arteries of 1,268 patients at high risk of cardiovascular disease because of multiple risk factors, such as smoking, diabetes, high blood pressure, high cholesterol, or known blockages in other blood vessels such as the coronary arteries.

    Then they focused on the 574 patients with clearly demonstrable plaque buildup in the carotid arteries.

    Six to nine months later, these patients all had repeat ultrasounds to measure changes in their plaque.

    Reiter's team used the ultrasound images and a computer-assisted evaluation (called gray-scale median or GSM) to evaluate the darkness of the plaque and its density. If plaque appears darker, it has a low GSM and is thought to be unstable, more likely to rupture or burst.

    "Our study is the first using repeat GSM testing for the assessment of an individual's cardiovascular risk," Reiter says.

    Next, the researchers looked at whether the GSM levels had decreased -- considered a bad sign, reflecting unstable plaque -- or increased (a neutral to good sign) and whether the patient had had a cardiovascular event during the follow-up, for a median of three years.

    Over a follow-up of slightly more than three years, the GSM levels decreased in 230 patients, or 40%, and increased in 344, or 60%. Those in the lowest GSM group, with the darkest plaque, were about 1.7 times more likely to have a cardiovascular event than those whose GSM went up the most, reflecting less dense plaque, during the follow-up.

    Those whose GSM declined the most had a 68% survival rate at three years, compared to a 78% survival for those whose GSM increased.

    The study is published in the September issue of the journal Radiology.

    Ultrasound Predicts Stroke, Heart Attack: Second Opinions

    Evaluating plaque at a single time point "is not as predictive an outcome as following it over time," says Nick Bryan, MD, a professor of radiology at the University of Pennsylvania, Philadelphia, and a spokesman for the American College of Radiology. That's a strength of the study, he says.

    Another strength, he says: They used the ultrasound tests to predict cardiovascular events anywhere in the body, not just in the carotid artery.

    So would a repeat ultrasound have helped Russert?

    Too soon to say, Bryan says. "We don't know how well this [finding about repeat ultrasound] would apply to the general population," he says. In the study, the average age was 72. "This is not ready for clinical applications. It is a very interesting observation that will need a lot of follow-up."

    "There is a bias," agrees Pablo Abbona, MD, a radiologist at Santa Monica-UCLA Medical Center & Orthopaedic Hospital in Santa Monica, Calif. "The patients are all in a high-risk population."

    Another expert, Ravi Dave, MD, a cardiologist at Santa Monica-UCLA Medical Center & Orthopaedic Hospital and an associate professor of medicine at the University of California, Los Angeles, pointed out that although ultrasound is readily available, "not all labs have GSM."

    Reiter agrees that more study is needed.

    Lifestyle changes shouldn't be ignored, Dave says. "The current aggressive treatment of patients at high risk should be continued," he says. That means encouraging them to exercise if possible, eat a healthful diet, and control blood pressure, blood sugar levels, and cholesterol.

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    SBI launches loan scheme for poor heart patients...

    State Bank of India (SBI), the country’s largest commercial bank, today launched a loan product aimed at the poor heart patients. Named ‘SBI Hrudaya Suraksha Scheme’, the exclusive loan product is extended only for patients undergoing cardiac treatment at the Narayana Hrudayalaya in Bangalore.

    The loan product was launched at the hands of Muhammad Yunus, founder, Grameen Bank of Bangladesh and Nobel Laureate for peace in 2006.

    Speaking on the occasion, SBI Chairman O P Bhatt, said SBI has been taking several initiatives to reach out to the larger sections of the society and the new loan scheme is aimed at helping the poor to undergo heart surgeries was one such initiative. The bank will come out with many more complex products in association with Narayana Hrudayalaya in the future, he said.

    Mahpara Ali, chief general manager, SBI, Bangalore, said the SBI Hrudaya Suraksha Scheme is a hassle-free loan product that will help the poor patient meet the shortfall in his medical expenditure.

    Under the product, SBI would extend around 80 per cent of the medical expenditure or Rs 50,000, whichever is lower. The borrower will have to repay the loan in six months with no interest for the first three months.

    Later, the loan amount will have to be repaid at an interest rate of 8.5 per cent. However, the loan scheme is available only to poor patients and as per the recommendation of the hospital. The bank expects to lend to about 30-50 patients per month initially, she said.

    “We need to bring in innovative schemes and investments to shore up healthcare cover in the country. Healthcare, especially heartcare, needs huge investments. The present demand is 25 lakh heart procedures a year, but only 80,000 procedures are carried out across various hospitals,” said Dr Devi Prasad Shetty, chairman and managing director, Narayana Hrudayalaya.

    Ali said, “Talks are on with Narayana Hrudayalaya as to how to link self help groups (SHGs) in Karnataka for healthcare schemes. Integration of SHGs and healthcare schemes are being worked out. State Bank of India along with few non-government organisations (NGOs) in Karnataka has exposure to 50,000 SHGs and has disbursed loans to the tune of Rs 200 crore,” she added.

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    Drug trials in India under investigation after 49 babies die at leading hospital...

    The death of 49 babies used to test experimental drugs at one of India’s top hospitals has raised concerns that ethical standards are being compromised as the country becomes the world’s leading destination for clinical trials on human beings.

    The deaths occurred over a period of 30 months at the Delhi-based All India Institute of Medical Sciences (AIIMS), an elite medical college and public hospital renowned for providing low-cost treatment to the poor.

    The dead babies were part of a pool of 4,142 infants used in a total of 42 clinical trials – one of the final stages of drug development – at AIIMS since January 2006, many for Western companies. Of the children used in the trials, 2,728 were aged under a year old.

    The mortality rate among the babies, many of whom were seriously ill before they underwent tests, was 1.2 per cent – significantly below the 4 per cent for all patients treated at the hospital. However, the age of those selected for testing has shocked many in India and there are fears that the increasingly lucrative drug-testing industry may be cutting corners because of a shortfall of staff trained in medical ethics and best practice.

    Manish Tiwari, a spokesperson for the Congress party, which heads India’s coalition Government, said: “The practice of using infants like guinea-pigs for drug testing must end.”

    Campaign groups have voiced concerns that the poor, often illiterate, parents who make use of the publicly subsidised healthcare that is available at institutions such as AIIMS do not understand the implications of putting forward children to test new drugs.

    Rahul Verma, of the Uday Foundation for Congenital Defects and Rare Blood Groups, which exposed the AIIMS deaths after a request under freedom of information laws, said: “If you are rich in this country you go to a private doctor and you certainly don’t put your child up to be experimented on.”

    India has become the leading destination for international pharmaceutical companies to outsource clinical trials, largely because of the diverse genetic pool offered by its vast population and the low cost of doing business.

    Drug tests on human beings are forecast to become a £1 billion-a-year industry in India by 2010. According to the Indian Pharmaceutical Alliance, GlaxoSmithKline, the London-listed pharmaceutical giant, and Johnson & Johnson, its US-based peer, are the two leading groups engaged in testing new drugs in India, each conducting 22 trials over the past year.

    There is no suggestion that either company is involved in the testing that led to the deaths.

    However, recent research by the Indian Government’s Planning Commission highlighted a chronic shortage of trained staff. A report found that the country is short of between 30,000 and 50,000 research personnel, including trial investigators, auditors, staff qualified to serve on ethics committees and data safety management boards.

    The country’s regulatory infrastruc-ture has been found to be weak and the office of the Drugs Controller, which has to approve drugs trials, including those at AIIMS, is understaffed.

    A spokesman for AIIMS, which has a strong international reputation, said that it was important to note that it was not yet known how many of the deaths occurred among babies given drugs and how many among those in control groups, who received placebos. “Many of these babies were very ill,” he said.

    It is understood that an inquiry into the deaths ordered by Anbumani Ramadoss, the Indian Health Minister, will focus on two trials carried out at AIIMS funded by the World Health Organisation and the Indian Government. It is not known what treatments were being tested.

    Experts say that the entry of large Western drugs developers into India has raised safety and ethics standards but admit that India’s regulatory systems are failing to keep pace with a boom in clinical trials.

    Rashma Cama, of the Indian Institute of Clinical Research, said: “Informed consent is now the norm and regulations have become stricter but there is a need for savvier investigators.”

    AIIMS denied any slip in standards. It said that illiterate parents have a document approved by the hospital’s in-house ethics committee read out to them that “outlines the risks and benefits and emphasises that parents/ guardians can opt out of the trial any time they want”.

    About 139 new trials were ousourced to India last year, putting it well ahead of the second-placed China, which had 98. The market value for clinical trials outsourced to India is estimated to stand at about £150 million, having increased by 65 per cent last year. It is expected to hit between £750 million and £1 billion in the next two years.

    Documents showed that Shire, the British-based group, was named by the hospital as being among the five leading testers of drugs at AIIMS.

    Shire, which is testing a treatment for Gaucher’s disease, a rare inherited disorder, at AIIMS, said that no children had died in its trials.

    A spokesman for the company said: “All the patients enrolled in the trials must be at least two years of age and there is a vast age range in the trials.

    “This trial has been approved by a local ethics committee and regulatory bodies in India, and follows good clinical practices as outlined by the international conference on harmoni-sation.”

    Trial and error

    £500m Average cost of bringing a new drug to market. Human clinical trials are the most expensive phase of drug development

    60 Percentage by which costs can be cut by holding trials in India

    400 The approximate number of trials under way in the country

    £1bn Predicted value of the industry to India by 2010

    Source: Times archive

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    Monday, August 18, 2008

    HIV vaccine trial shows promising results...

    Indian Council of Medical Research (ICMR), National AIDS Control Orgainsation (NACO) and International AIDS Vaccine Initiative (IAVI) said that the phase-1 of clinical trials of the AIDS vaccine has shown that it has suitable levels of safety and was well tolerated. The drug has completed the phase successfully.

    The three organizations further said that the response levels of volunteers suggested that the vaccine, whose trail was relied on a Modified Vaccinia Ankara (MVA) based AIDS vaccine candidate (TBC-M4), holds promise to fight the virus effectively.

    The two doses of the Modified Vaccinia Ankara (MVA) were used on trial basis. 82% of the volunteers were given a low dose and 100% of the volunteers were given high dose. They registered immune responses to the vaccine after three injections were given.

    The candidates who were given high dose have been measured to have shown immunity which is higher than the majority of AIDS vaccines till date. It was found that the strength and the diversity of resistance power are different.

    If the vaccine is utilized with other candidate AIDS vaccine, the resistance power might rise to a further level.

    S.K. Bhattacharya, the additional director general of ICMR said, “We are pleased to see that the MVA-based candidate tested in Chennai was safe and showed promising initial immune responses. We do not know whether these observed responses will ultimately translate into an effective vaccine ... but hope to learn more through further testing.”

    In January 2006 phase-1 of the clinical trial was started at the Tuberculosis Research Centre (TRC), an ICMR institute in Chennai and trail was finished in January 2008.

    In Chennai the trial was conducted under the aegis of a MoU between the central government through ICMR and NACO and IAVI. YRG CARE, which was collaborated with TRC, helped increase the community during the trial of the phase I.

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    New Imaging Technique Could Spot Early Cancers...

    The technology takes advantage of the "photoacoustic effect," a physical phenomenon in which light hits an object and is converted into sound. Shining light on an object heats it up, de la Zerda said.

    "Think of a black car parked in the sun," he said. The car warms up, and the metal expands. Later, the cooling, shrinking metal makes little "tink" sounds.

    "We shine light on a nanotube and listen to the ultrasound waves coming out of it," de la Zerda said.

    The technique is faster and costs less than an MRI scan and requires no ionizing radiation like a PET-CT scan, the researchers said. Its ability to look 2 inches deep into the body would make it helpful for looking at tissues in the breast or prostate gland.

    Nanotechnology may offer doctors a noninvasive way to detect early stages of cancer and also help monitor treatment, a new report says.

    Researchers at Stanford University School of Medicine recently demonstrated the new approach using "smart" targeted carbon nanotubes to zero in on cancer cells in living mice, followed by laser scans of the animals in which the nanotubes absorbed the laser energy and released ultrasound waves to highlight the locations of the tumor cells.

    "This imaging modality allows us to see things we've never been able to see before," study author Adam de la Zerda, a doctoral student in Stanford electrical engineering, said in a news release issued by the university.

    The technology takes advantage of the "photoacoustic effect," a physical phenomenon in which light hits an object and is converted into sound. Shining light on an object heats it up, de la Zerda said.

    "Think of a black car parked in the sun," he said. The car warms up, and the metal expands. Later, the cooling, shrinking metal makes little "tink" sounds.

    "We shine light on a nanotube and listen to the ultrasound waves coming out of it," de la Zerda said.

    The technique is faster and costs less than an MRI scan and requires no ionizing radiation like a PET-CT scan, the researchers said. Its ability to look 2 inches deep into the body would make it helpful for looking at tissues in the breast or prostate gland.

    The method is sensitive enough to detect minute, early tumors that normally can't be seen, the researchers said. Also, the scanners could also be adapted to endoscopes, enabling views of internal organs.

    Coatings on the nanotubes could also be altered so doctors could receive diagnostic information about a tumor, de la Zerda said. For instance, molecules put on nanotubes could tell a doctor which anti-cancer drugs would work on a breast tumor.

    "We will be able to ask a tumor: Are you responding to chemotherapy or not?" de la Zerda said. "This should give us early information long before the tumor shrinks or grows."

    A companion study in mice, published inNature Nanotechnologyin April, found the carbon nanotubes appear to be safe to inject, although further testing is needed before testing can begin in humans.

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    India may be hub of chronic illness...

    According to a World Health Organisation report Preventing Chronic Diseases — A Vital Investment, 350 million people will die in the next 10 years of chronic disease and a significant proportion of these will be in India.

    To help fight such diseases is an initiative launched by the Piramal group with the Associated Chambers of Commerce and Industry of India. Helpyourbody, a nationwide campaign against chronic diseases, was inaugurated by former president APJ Abdul Kalam at KC College in Churchgate on Saturday. Helpyourbody will kick off in three phases, comprising a panel of experts in diabetology, cardiology and orthopaedics, as crusaders in the first phase. “Each doctor will impart information to patients on risk factors for chronic diseases, diagnosis and management,” said Dr Swati Piramal,
    director, Piramal Healthcare Ltd.

    The campaign will focus on ailments like hypertension, heart disease, diabetes, arthritis, cancer, addiction and mental health. Tests will be carried out at 90 diagnostic centres across 47 cities and detection camps will be organised in 20 cities across India
    reaching out to 10,00,000 people.

    “India is expected to be the chronic disease capital in the world. The government, private sector, NGOs and medical fraternity should help combat these diseases,” said Piramal.

    Kalam said, “Corporates should carry out periodic check-ups of employees over 40 years. Students should become ambassadors for this cause. Rural areas need to have mobile clinics and awareness among taxi-drives and dabbawallahs should be increased.”

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    R.C. Deka to be new director of AIIMS...

    R.C. Deka, dean All India Institute of Medical Sciences (AIIMS), is to be the institute's new director.

    A high-level selection committee on Monday cleared the name of Deka for the post which was lying vacant after the retirement of renowned cardiologist P. Venugopal in early July.

    According to health ministry sources, the 17-member selection committee headed by Health Minister Anbumani Ramadoss, after a marathon meeting on Monday afternoon, forwarded Deka's name to the appointment committee of the cabinet.

    Initially eight names were picked from a set of 60 applicants, but finally Deka's name was selected.

    “The name has been forwarded to the appointment committee headed by Prime Minister Manmohan Singh. A formal announcement will be made soon,” a ministry source said.

    Deka, who has been serving AIIMS for over two decades, is currently the head of the ENT (ear, nasal, throat) department.

    Deka's two years' as dean of AIIMS and also in a senior administrative post at the Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, went in his favour.

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