Hi all,
I am making a single thread for each and every medical topic, with news and research corresponding to it.
So this thread shall contain all DRUGS research news.
P.S. Please dont post DRUGS research news anywhere else on the forum.
Most importantly : PLEASE POST A DISCLAIMER BEFORE YOU POST THE NEWS AND A RELEVANT FOOTNOTE AT THE END OF THE ARTICLE. THIS IS A NEW RULE THAT APPLIES TO ALL THE POSTS HERE. A FOOTNOTE MAY CONTAIN YOUR OPINION OR VIEWS OR REFERENCE TO OTHER RELATED NEWS ARTICLES.
And please quote the original source and author.
Sample Disclaimer "This research news has been taken from a reputed news website. It has not been modified or recreated in way, as to preserve the authenticity of it. No Copyright Infringement is intended. This information is posted here for read-only basis. No part of this news is to be reproduced elsewhere, unless due credit is given to the original source and author.
WASHINGTON (Reuters) - U.S. health officials and drugmaker GlaxoSmithKline Plc are likely to face tough questioning from lawmakers on Wednesday over their handling of data suggesting a heart risk with the widely used diabetes pill Avandia.
A furor erupted last month when a Cleveland Clinic analysis linked Avandia to a 43 percent higher chance of having a heart attack. The Food and Drug Administration and Glaxo say other data provided conflicting evidence.
Glaxo has said it gave regulators information in August 2006 that estimated a 30 percent higher heart-attack risk with Avandia. Some critics question why neither the FDA nor Glaxo alerted patients sooner.
"The American people deserve to know why eight years after FDA approved Avandia, it's still unclear whether the drug is harmful or helpful," Rep. Henry Waxman, a California Democrat and chairman of the House Oversight and Government Reform Committee, said in a statement.
Millions of patients take Avandia, known generically as rosiglitazone, and sales topped $3 billion last year. But analysts this week said prescriptions have fallen 16 percent since the Cleveland Clinic report as doctors switch patients to Takeda Pharmaceutical Co. Ltd.'s rival drug Actos.
Glaxo released early findings on Tuesday from an ongoing company-funded study that was unable to show a link to heart attacks. It also defended itself and reassured patients in full-page advertisements in at least a dozen U.S. newspapers.
"Patients and physicians should find these data reassuring," said a statement by Moncef Slaoui, London-based Glaxo's research and development chairman.
Still, several experts said the new evidence still suggests a greater risk of heart attack.
Waxman's panel is set to question Slaoui, FDA Commissioner Andrew von Eschenbach; cardiologist Steve Nissen, who wrote the Cleveland Clinic analysis, and others.
CRITICISM OF FDA
Concerns over Avandia have sparked an outcry from members of Congress who have blasted the FDA in recent years as being slow to respond to problems with other medicines, including Merck & Co Inc.'s withdrawn arthritis drug Vioxx.
The controversy comes as Congress considers legislation meant to bolster the FDA's oversight of drug side effects. Some critics are seeking to use the Avandia case to push for tougher safeguards.
Waxman said the House hearing would focus on whether the FDA is properly safeguarding the public and whether changes in the agency's authority, resources or leadership might be needed.
The FDA is finishing its own Avandia analysis to better assess the heart risk but has not said when it will be completed.
FDA officials have defended their actions, saying they had to weigh warning the public against concerns that diabetic patients could stop taking their medication altogether.
"I believe we did it right with regard to Avandia," von Eschenbach told reporters last week.
The agency has scheduled a July 30 public meeting to discuss the drug's risks.
huge brands are too failing to stop this menace instead they too seem to take part in the play with human lives ! a pill supposed to stop something creates something unexpected to the patient but knowingly expected by the manufacture . a strict control and research and test of all drugs should be made to save innocent public trusting huge brands and following such famous names .
if huge brands fails then what about the rest , they too will follow the same dirty magic to boost their profit and sales .
many thanks for the moderator ( Monica) who posted this report
CHICAGO: An experimental drug prevented mice from developing diabetes and heart disease and might one day be used to stave off the diseases in humans, US researchers said on Wednesday.
The drug, which was developed by researchers at Harvard University in collaboration with Bristol-Meyers Squibb, blocked a protein needed to move fats around the body and made the mice resistant to the diseases.
The drug also reversed symptoms of diabetes and heart disease in mice that had them. "It shoots two big birds with a single [bleep]," said Gokhan Hotamisligil, chairman of the Harvard School of Public Health's Department of Genetics and Complex Diseases.
Mice given the drug became immune to diabetes, heart disease and other metabolic disorders even though they were severely obese or had high cholesterol and extremely high-fat diets.
Hotamisligil's work, published in the journal Nature, builds on his lab's prior discovery of a gene that is linked with diabetes and obesity in mice. They found that mice who lacked the gene resisted those diseases. "No matter what we did, we couldn't get them to develop diabetes," he said in an interview.
Source : timesofindia
By Shankar Vedantam
Washington Post Staff Writer
Sunday, June 10, 2007; Page A06
For more than a decade, families across the country have been warring with the medical establishment over their claims that routine childhood vaccines are responsible for the nation's apparent epidemic of autism. In an extraordinary proceeding that begins tomorrow, the battle will move from the ivory tower to the courts.
Nearly 5,000 families will seek to convince a special "vaccine court" in Washington that the vaccines can cause healthy and outgoing children to withdraw into uncommunicative, autistic shells -- even though a large body of evidence and expert opinion has found no link. The court has never heard a case of such magnitude.
The shift from laboratory to courtroom means the outcome will hinge not on scientific standards of evidence but on a legal standard of plausibility -- what one lawyer for the families called "50 percent and a feather." That may make it easier for the plaintiffs to sway the panel of three "special masters," which is why the decision could not only change the lives of thousands of American families but also have a profound effect on the decisions of parents around the world about whether to vaccinate their children.
A victory by the plaintiffs, public health officials say, could increase the number of children who are not given vaccines and fall sick or die from the diseases they prevent.
Economics and politics intersect in the case with questions of health and the deepening mystery of soaring autism rates. Advocates of the vaccine theory have argued that the increase in cases was triggered by a mercury-based preservative in vaccines that, they say, is toxic to children's brains.
Under pressure from the advocates and to keep the issue from disrupting vaccination programs, U.S. officials began phasing out the additive, thimerosal, in children's vaccines around 1999 while maintaining that there was no hard evidence that it was dangerous. But thimerosal is still used in vaccines across much of the developing world. If the vaccine court decides that the preservative caused autism, parents of children in poor countries are likely to protest its inclusion, but removing it would make vaccines much more expensive and potentially put them out of reach for many.
Gary Golkiewicz, chief special master in the U.S. Court of Federal Claims, where the case is to be heard, said he is aware of the larger ramifications. But the court's job, he said, is only to focus on whether plaintiffs show a plausible link between vaccines and autism.
About 20 experts are expected to testify in the case, which will involve a staggering amount of complicated epidemiology and Biochemistry
. Golkiewicz said a ruling could be a year off.
Experts for the government will argue that a range of epidemiological studies found no link between vaccines and autism, as the prestigious Institute of Medicine concluded in a 2004 report. The institute, part of the National Academies that was chartered by Congress to advise the government and the public on matters of science, dismissed the vaccine-autism theory, which is mostly based on Biochemistry
studies on the toxic effects of mercury.
Large international studies -- and preliminary evidence from the United States -- suggest that after thimerosal was removed from children's vaccines, autism rates continued to soar.
If thimerosal was the cause, removing it should have sharply lowered autism rates, scientists say. Although definitive national evidence is not in -- children vaccinated after 1999 are just beginning to enter school, which is the point at which many receive a diagnosis -- data from California suggest that autism rates are continuing to climb steeply.
The cases are rising, experts say, primarily because of better diagnosis and services: Parents and teachers are more attuned to the signs of autism, and doctors are better equipped to spot it than they were two decades ago. Also, the boundaries of the diagnosis have expanded to include a range of problems under an umbrella known as autism spectrum disorders.
The plaintiffs acknowledge that their case is far from airtight scientifically. But Kevin Conway, a Boston attorney representing the family of 12-year-old Michelle Cedillo of Yuma, Ariz., whose claim was designated the opening test case for more than 4,800 plaintiffs, said that even if the science is equivocal, he has a good legal argument, which is all he needs.
"There is a difference between scientific proof and legal proof," Conway said. "One is 95 percent certainty, and the other is . . . 50 percent and a feather."
Besides, Conway added, those who support the vaccine-autism theory did not put all their eggs in the thimerosal basket. They are also arguing that something else in vaccines might be making children sick.
Like many other advocates of the link, Conway said he believes that vaccines in general are a good thing and have saved many lives. In an age of bioterrorism, moreover, vaccines are not just a health priority but a national security priority. But Congress's efforts to shield vaccine makers from lawsuits over the rare but inevitable side effects of vaccines have given the companies no incentive to make vaccines as safe as possible, Conway said.
Congress set up the vaccine court to provide compensation for individuals harmed by those side effects, because lawsuits were threatening to put vaccine makers out of business.
The law requires people claiming they were harmed by a vaccine to bring the case in the special court first, but if they lose, they can still file suit in civil courts.
Scientific advocates for the vaccine-autism theory, such as the father-and-son team of Mark and David Geier of Silver Spring, say fears about damaging public health programs have prompted scientists and the government to hide evidence of a problem. Many of the families believe that the medical establishment and the U.S. Centers for Disease Control and Prevention have conspired in a massive coverup.
Peter Hotez, president of the Sabin Vaccine Institute and a biology professor at George Washington University, who has a 14-year-old autistic daughter, said the controversy has distracted from the real problem: finding services for rising numbers of autistic children and ramping up research to find a cure.
"We are absolutely confident Rachel's vaccines have nothing to do with her autism," he said. "If we could roll back the clock, we would give her all the vaccines again."
But the family of severely autistic Michelle Cedillo, who arrived in Washington on Friday for the trial, disagrees.
Michelle was a healthy 15-month-old when she was given the measles-mumps-rubella vaccine, said her mother, Theresa. The dozen or so words she had been able to speak -- including Mommy, Daddy, baby, kitty and juice -- vanished. She developed a high fever one week after the shot and went rapidly downhill. Today, she does not speak and is totally dependent on caregivers. She suffers from seizures, arthritis and inflammatory bowel disease and is nearly blind.
Cedillo said she is "not anti-vaccine" and not very interested in playing the blame game or weighing in on matters of public policy.
"I am not a scientist. I am not a doctor," she said in an interview. "We want to focus on Michelle and find out what happened and get the help for her that she needs."
Print CHICAGO (Reuters) - A vaccine targeting a deadly strain of meningitis proved to be safe and highly effective in protecting African children, researchers said on Friday, raising hope that it may help prevent epidemics that afflict many African countries.
The new vaccine targets A Neisseria meningitidis, a leading cause of bacterial meningitis in Africa's so-called "meningitis belt," a group of 21 countries in sub-Saharan Africa.
Researchers from the Meningitis Vaccine Project said the new vaccine produced an antibody response that was 20 times greater than current vaccines.
"The length of time individuals will be protected is probably measured in decades rather than in years," said Dr. F. Marc LaForce, director of the Geneva, Switzerland-based Meningitis Vaccine Project, in a telephone interview.
The group is a partnership between the World Health Organization and the Seattle-based PATH, an international nonprofit.
Existing vaccines do not offer long-lasting protection and do not protect very young children, he said.
The new vaccine is made by the private Serum Institute of India Ltd.
Researchers compared the new vaccine to an older one in a study of 601 children in Mali and Gambia aged 12 to 23 months.
LaForce said the improved antibody response came after only one dose, suggesting it may change how African countries fight meningitis. The trial is still underway and patients will receive a second dose. There were no reported safety problems after four weeks.
"This is a very potent vaccine that can be used prevent rather than proactively treat," he said.
The next step is to study the vaccine in 2- to 29-year-olds -- the target population for most of the group's planned mass vaccination efforts. Testing will take place in Mali, Gambia, and at least one other African country.
If all goes well, next year the group hopes to immunize the entire population of those aged 1 to 29 from an African country experiencing a high degree of disease, he said.
The group is hoping the vaccine may be able to protect an entire population, including those who have not been vaccinated.
If it works, LaForce thinks the vaccine could be available in Africa for about 40 cents per dose within the next two to three years.
Meningitis is an infection of the thin lining that surrounds the brain and spinal cord. Meningitis groups A, B, and C cause most of the cases worldwide, but group A causes deadly epidemics every 8 to 10 years in an area of Africa that spreads from Senegal and Gambia in the west to Ethiopia in the east.
The largest epidemic in this region in 1996-1997 struck 250,000 people and killed 25,000.
Written by Neil Simmons
Tuesday, 12 June 2007
Autism is a complex developmental disorder that severely impairs a child's ability to communicate and interact with other people. Although the precise cause of autism is unclear, a plethora of theories have been suggested. One theory suggests a genetic link, while another holds vaccines containing mercury as the culprit. Parents of autistic children are now seeking legal recourse on whether mercury in vaccines caused autism in their children.
Thimerosal is a preservative in vaccines that contains 49 percent ethyl mercury. Mercury is a known neurotoxin or in other words is a chemical that causes untold harm to the brain, especially a child's developing brain. Scientists thought that autism might be one such toxic manifestation of mercury in vaccines. In 2002, thimerosal was phased out of childhood immunizations mainly because the Public Health Service and the American Academy of Pediatrics advocated it.
However it is possible that the mercury in the vaccines administered to children before 2002 did play a role in the development of autism. In the present case Cedillo v. Secretary of Health and Human Services, the United States Court of Federal Claims in Washington is all set to hear data that vaccines containing mercury are a causal factor in autism.
The case will be followed very keenly because there are another 4,800 such cases pending before the court.
Autism-vaccine links emerged in the late 1990s when the State of California released a report suggesting a 273 percent increase in the number of persons with autism between 1987 and 1998, the New York Times reports. The cases of autism are definitely on the rise in American children, whether it is due to improved diagnosis or due to other factors remains unclear.
In 2004, the Institute of Medicine examined data on links between vaccines containing mercury and the incidence of autism and found no evidence linking thimerosal to autism. The Institute of Medicine's panel based its conclusions on five large studies conducted in United States, Denmark, Sweden and Britain in 2001. These studies examined thousands of children, but failed to find any link between autism and thimerosal.
The IOM report said it was an undisputed fact that high doses of mercury did cause substantial neurological damage. However no symptoms resembled that of autism, the report suggested. It added that genetics was the main causative factor as many studies had noted that autism started prenatally.
A review by the Environmental Working Group suggested that autistic children had a biomarker that rendered them susceptible to mercury and heightened their risk of developing the neurological disorder. The report cited a study by Dr. Jill James of the University of Arkansas School of Medicine, which found that children with regressive autism had high levels of oxidative stress, which made it hard for their bodies to get rid of mercury.
The study cited the following factors as well (as available on
* The indisputable toxicity of mercury to the brain, particularly the developing brain (Limke 2004, Clarkson 2002, Mahaffey 1999).
* Peer-reviewed reports showing that autistic children are extremely poor at ridding their bodies of mercury as measured by mercury hair levels (Holmes 2003).
* The recent finding that autism-like symptoms are triggered by thimerosal in mice with a predisposition to autoimmunity (Hornig 2004).
* The fact that the prevalence of autism in boys is four times that in girls, and that boys have elevated incidence of damage from mercury exposure in epidemiologic studies (Vahter 2002).
The study said that it did not find a credible link between mercury in vaccines and autism, but there was sufficient evident to suggest mercury played some role.
This theory was reinforced by a study in 2006 which showed that autism cases declined when mercury was banned from vaccines. Using data from CDC’s Vaccine Adverse Event Reporting System (VAERS) and the California Department of Developmental Services (CDDS), lead authors David A. Geier, B.A. and Mark R. Geier, M.D., Ph.D found that autism rates hit a high of 800 in May 2003, but dropped to 620 in 2006.
The authors suggested that the 22 percent decline in autism cases was mainly due to the restriction of mercury in vaccines.
The U.S. Centers for Disease Control and Prevention estimates that one in every 150 children has autism and that 560,000 people aged till 21 in the United States have autism.
Experts have tried to dispute the vaccine-autism link by suggesting that children are naturally distressed by shots and that this is the age when autism is first diagnosed leading parents to believe that the vaccines cause it.
It will be interesting to see what the U.S. Court of Federal Claims rules in the autism-vaccine case pending before it. This ruling might set off a legal time-bomb if it decides that mercury in vaccines is indeed responsible for autism. However a battery of scientists is also ready to give the flip side of the opinion.
The drug isradipine, commonly used to treat blood pressure and stroke, could one day help to slow down or even stop the progression of Parkinson's disease, according to new research by US scientists.
The study is published in the early online edition of the journal Nature.
Scientists at Northwestern University in Chicago, Illinois, US, managed to show that isradipine slowed the progression of Parkinson's in mice, and are now planning clinical trials on humans.
Parkinson's occurs when dopamine cells in the brain die off. Dopamine is a chemical messenger or neurotransmitter that helps the brain to control movement. When the cells that release it die off, movement becomes harder to control, and eventually the affected person loses the ability to walk, talk and pick things up. There is no cure as yet for the disease.
About 1 million Americans live with Parkinson's; it is the second most common degenerative brain disease in the US (the first being Alzheimer's). People over 60 years old are at most risk, and risk increases with age.
The researchers at Northwestern University discovered that isradipine rejuvenates worn out dopamine cells.
Dr D. James Surmeier, who is Nathan Smith Davis Professor and chair of Physiology
at Northwestern University's Feinberg School of Medicine, and also head of the Morris K. Udall Center of Excellence for Parkinson's Disease Research at Northwestern, led the study. Sumrmeier has been researching Parkinson's for 20 years. He said their hope for this discovery was that:
"This drug will protect dopamine neurons, so that if you began taking it early enough, you won't get Parkinson's disease, even if you were at risk."
"There has not been a major advance in the pharmacological management of Parkinson's disease for 30 years," he said, explaining why this study is exciting.
"It would be like taking a baby aspirin everyday to protect your heart," he added.
As well as delaying or avoiding onset, it is possible that isradipine may significantly benefit people who already have Parkinson's. Surmeier and colleagues found that by rejuvenating the dopamine cells, isradipine also stops them from being killed off by toxins, because younger cells are less vulnerable. At the moment people with Parkinson's are treated with a chemical, L-DOPA, that turns into dopamine in the brain. This helps to reduce many of the symptoms in the early stages, but as the disease progresses, higher and higher doses are needed to achieve the same effect. Also, L-DOPA has side-effects, including unwanted movement.
The researchers hope that their discovery means that if the death of dopamine cells can be slowed down or halted even, then treatment with isradipine could help people with Parkinson's stay on L-DOPA longer with good effect.
Surmeier said:
"If we could double or triple the therapeutic window for L-DOPA, it would be a huge advance."
The discovery was made when Surmeier decided to look into whether the vulnerability of dopamine cells might be explained by their electrical activity. Dopamine cells, like all neurons, send electrical signals to other neurons, using ions. Dopamine cells are like pacemakers, they send electical impulses on a regular basis all the time. Scientists had already discovered that brain cells use sodium ions to carry the electrical charge.
However, Surmeier and his team found that in the case of dopamine cells it was not sodium ions that were being used but calcium. Calcium ions are more troublesome and volatile, and they have to be closely controlled in the brain cell by either sequestering them or pumping them out. This takes more energy than the sodium based method.
The researchers thought that perhaps the continual stress on the dopamine cells could be the reason they are more vulnerable to toxins and die off more quickly as the person gets older.
Another chance discovery helped to bridge the link toward therapeutic applicaton. Working on a different study, Surmeier found that young dopamine cells worked quite differently to older ones.
When the dopamine cells are young, they use sodium ions, but these are gradually replaced with calcium as they age. The change to calcium is what starts them becoming vulnerable to toxins. So the researchers decided to try and stop the calcium getting into the dopamine cells to see if they reverted to using sodium.
They gave mice isradipine, and it blocked the calcium from getting into the dopamine cells. At first they just went quiet, but within a few hours they started their electrical pulses again, but using sodium ions instead of calcium ones. Surmeier said that:
"This lowers the cells' stress level and makes them much more resistant to any other insult that's going to come along down the road. They start acting like they're youngsters again."
Deputy Director of the National Institute of Neurological Disorders and Stroke (NINDS), Dr Walter J. Koroshetz said:
"This animal study suggests that calcium channel blockers, drugs currently used to reduce blood pressure, might someday be used to slow the steady progression of Parkinson's disease."
June 11 (Bloomberg) -- Sanofi-Aventis SA's weight-loss pill may raise the risk of suicide and suicidal thoughts, U.S. regulators said in documents for an expert panel that will recommend whether the three-time delayed drug should be approved.
The medicine, to be known as Zimulti in the U.S., helped patients lose weight at the highest dose of 20 milligrams, the Food and Drug Administration staff said in the documents posted today on the agency's Web site. An agency advisory panel will meet June 13 to discuss whether the product's benefits of reducing weight, cholesterol and blood sugar outweigh its risks.
Zimulti, sold as Acomplia outside the U.S., is the first of a new class of drugs called CB1 antagonists that block receptors in the brain that regulate hunger and food intake, as well as acting directly on fat cells. Paris-based Sanofi expects sales of at least $3 billion a year from Acomplia as its older best- sellers, such as the sleeping pill Ambien, lose patent protection. Profit at Sanofi fell in the first quarter.
``The market is expecting the drug will get approved for obesity, but in light of these comments it could be a quite a close call,'' said Andrew Fellows, an analyst at Helvea Ltd. in London, in a telephone interview.
Shares of Sanofi fell 5 cents, or less than 1 percent, to 67.52 euros at the close of trading in Paris. They've declined 3.7 percent this year, trailing the 16-member Bloomberg Europe Pharmaceutical Index, which has fallen 2.6 percent in the period. Sanofi's U.S. depositary shares, each equal to half an ordinary share, fell 36 cents to $45.14 at 4:02 p.m. in New York Stock Exchange composite trading.
Suicide Concerns
The Sanofi pill was approved last year by regulators in Europe, where it competes with Roche Holding AG's Xenical and Abbott Laboratories' Meridia. Approval in the U.S. would open a market in which a third of the population is considered obese.
The FDA noted two suicides in clinical trials of volunteers testing the drug. The panel will be asked to discuss whether it can establish a causal link between the medicine and suicidal thoughts or actions.
The FDA usually follows the advice of its outside advisers, although it isn't required to do so. The agency will issue a decision by late July. Analysts say the FDA, which has delayed approval of the drug three times, may be wary about Acomplia's side effects.
The agency has come under pressure in recent weeks after a study showed a diabetes drug approved in 1999, GlaxoSmithKline Plc's Avandia, raised the risk of heart attacks.
FDA `Risk Averse'
``It was always suspected that there were safety issues,'' Fellows said. ``In recent times, the FDA has become more risk averse, especially if there is reasonable efficacy but there are question marks over side effects.''
Sanofi is seeking approval of the medicine as an adjunct to diet and exercise for the treatment of overweight people at risk of heart disease or for chronically obese people. The company has asked the FDA to also consider Zimulti as a diabetes treatment.
The drugmaker proposed a risk management plan for the U.S. that would restrict its use, excluding it from patients suffering from psychiatric illness and advising caution in people suffering from epilepsy.
The company is monitoring the drug's use in Europe and South America, where a total of 108,730 people had been prescribed it as of March 1, 2007.
Some patients who took part in clinical trials of Acomplia suffered from mood swings, anxiety and depression. Trial volunteers given the highest dose lost an average 5.3 kilograms (11.7 pounds) over a one-year period compared with a weight loss of 1.4 kilograms (3.1 pounds) among patients given a control pill. Acomplia significantly lowered the level of HbA1c, a measure of blood sugar, to within a safe range.
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