Aetna postpones sedation policy change
Wed, 27 Feb 2008 23:00:05 GMTBy STEPHEN SINGER, AP Business Writer
HARTFORD, Conn. - Aetna Inc. said Wednesday it will delay a proposed policy that would stop covering the cost of using anesthesiologists during colonoscopies. The policy had been opposed by a group of New Jersey doctors who said denying coverage of anesthesiologists to anxious patients would lead to fewer cancer screenings.
The Hartford-based insurer's policy was to take effect Apri1 1. Aetna said it will now be implemented after the U.S. Food and Drug Administration approves other forms of sedation.
"Implementation of our policy on April 1 would inconvenience our members ... and potentially depress cancer screening rates in the short term," said Dr. Troyen Brennan, Aetna's chief medical officer.
Aetna initially announced its policy in December in an attempt to address questions about the medical necessity of an anesthesiologist's services during routine upper and lower endoscopic procedures, such as colonoscopies. Aetna would still cover anesthesiologists for high-risk patients.
The change was opposed by the Medical Society of New Jersey, which said patients should be assured that their insurance coverage includes the cost of anesthesiologists who administer propofol, an anesthesia the doctors say is effective and comfortable.
A call was placed to the group seeking comment.
Aetna has said moderate sedation works just as well and does not require an anesthesiologist, which can drive up the cost of the procedure by between $200 and $1,000. Gastroenterologists generally decide whether to use propofol or moderate sedation.
Aetna said it hopes delaying the policy will allow adequate time for new "attractive, patient-friendly alternatives to anesthesiologist-monitored sedation services" to be approved by the FDA.
New medical devices, as well as new sedatives, are expected on the market during the late summer and are in review with the FDA now, Aetna said.
Once that occurs, Aetna will implement its policy, Brennan said.
Colorectal cancer is the second leading cause of cancer death in the United States and regular screening could eliminate as many as 60 percent of deaths each year, according to the U.S. Centers for Disease Control and Prevention.
Kids vaccine linked to fever seizures
Thu, 28 Feb 2008 01:28:09 GMTBy MIKE STOBBE, AP Medical Writer
ATLANTA - Children suffered higher rates of fever-related convulsions when they got a Merck & Co. combination vaccine instead of two separate shots, according to a new study presented Wednesday.
The results prompted a federal advisory panel on vaccines to water down their preference for the combo vaccine ProQuad, which protects against measles, mumps and rubella as well as chickenpox.
In the study of children ages 12 months through 23 months, the rate of seizures was twice as high in toddlers who got ProQuad, compared with those who got one shot for chickenpox and one for the three other diseases.
The risk translates to about one extra case of convulsion for every 2,000 doses of ProQuad given said Dr. Nicola Klein, who lead the federally funded study. She presented the data at a meeting of the Advisory Committee on Immunization Practices.
The study focused on children who develop fevers and then go into convulsions — an occurrence that frightens parents but usually has no lingering consequences. There were no deaths in the new study.
ProQuad was licensed in 2005. It's been in extremely short supply since last year, when Merck suspended production because of manufacturing problems. The company expects to resume ProQuad production next year.
The panel had previously taken a position that they preferred doctors give children as few needlesticks as possible, and that ProQuad is preferable to giving separate shots.
It voted Wednesday to amend that, to say they're no longer voicing a preference for ProQuad over the separate shots.
"Safety, shortages, delivery issues — lots of reasons not to state such a strong preference," said member panel Patsy Stinchfield, an infectious disease expert at Children's Hospitals and Clinics of Minnesota.
Merck officials said their own research, though preliminary, also showed a doubling of the risk in children within five to 12 days of vaccination. However, the occurrence was low — about 5 cases in 10,000, Merck officials said.
They said there was five times more chickenpox antigen, the key ingredient, in the ProQuad shot than in the stand-alone chickenpox shot. But they said it's not clear that would explain the difference in seizure rates.
For some reason, the difference disappears when comparing rates for 30 days, Merck officials added.
Klein's research checked seizure rates only at seven to 10 days after vaccination, and looked at about 43,000 kids who got ProQuad and 315,000 who got the two other shots together. It found fever-related seizures occurred at a rate of 9 per 10,000 children vaccinated with ProQuad, compared with 4 per 10,000 for those who got separate shots.
Klein is co-director of Kaiser Permanente Vaccine Study Center in Oakland, Calif., one of seven sites in the study. Her work was funded by the U.S. Centers for Disease Control and Prevention.
ProQuad costs $124 per dose, about the same as the two other shots combined.
WHO says drugresistant TB spreads fast
Wed, 27 Feb 2008 22:59:39 GMTBy MARIA CHENG, AP Medical Writer
LONDON - Drug-resistant tuberculosis is spreading even faster than medical experts had feared, the World Health Organization warned in report issued Tuesday. The rate of TB patients infected with the drug-resistant strain topped 20 percent in some countries, the highest ever recorded, the U.N. agency said.
"Ten years ago, it would have been unthinkable to see rates like this," said Dr. Mario Raviglione, director of WHO's "Stop TB" department. "This demonstrates what happens when you keep making mistakes in TB treatment."
Though the report is the largest survey of drug-resistant TB, based on information collected between 2002 and 2006, there are still major gaps: Data were only available from about half of the world's countries.
In Africa, where experts are particularly worried about a lethal collision between TB and AIDS, only six countries provided information.
"We really don't know what the situation is in Africa," Raviglione said. "If multi-drug resistant TB has penetrated Africa and coincides with AIDS, there's bound to be a disaster."
Raviglione said it was likely that patients — and even entire outbreaks of drug-resistant TB — were being missed.
Experts also worry about the spread of XDR-TB, or extensively drug-resistant TB, a strain virtually untreatable in poor countries. When an XDR-TB outbreak was identified in AIDS patients in South Africa in 2006, it killed nearly every patient within weeks. WHO's report said XDR-TB has now been found in 45 countries.
Globally, there are about 500,000 new cases of drug-resistant TB every year, about 5 percent of the 9 million new TB cases. In the United States, 1.2 percent of TB cases were multi-drug resistant. Of those, 1.9 percent were extensively drug-resistant.
The highest rates of drug-resistant TB were in eastern Europe. Nearly a quarter of all TB cases in Baku, Azerbaijan, were drug-resistant, followed by about 20 percent in Moldova and 16 percent in Donetsk, Ukraine, WHO said.
High rates of drug-resistant TB were also found in China and India, the world's two most populous nations that together are home to half the world's cases.
Drug-resistant TB arises when primary TB treatment is poor. Countries with strong treatment programs, like the U.S. and other Western nations, should theoretically have very little drug-resistant TB.
That is not the case in China, however, where the government says 94 percent of TB patients complete their first TB treatment.
"There's a huge, gross discrepancy there if they are then reporting 25 percent of the world's multi-drug resistant TB cases," said Mark Harrington, executive director of Treatment Action Group, a public health think tank. "They are clearly nurturing a multi-drug resistant TB epidemic and failing to report XDR-TB at all."
With growing numbers of drug-resistant TB patients, there is concern some national health systems will soon be overwhelmed.
"We are totally off track right now," said Dr. Tido von Schoen-Angerer, executive director of Medecins Sans Frontiere's Campaign for Access to Essential Medicines. He said only 30,000 multi-drug TB resistant patients were treated last year.
Experts said new drugs are needed if the outbreak is to be curbed, along with new diagnostic tests to identify drug-resistant TB strains faster — current tests take about a month for results.
WHO said a new diagnostic test able to provide results within a day is being tried in South Africa and Lesotho. If successful, the test could be introduced across Africa in a few months, though new labs would be needed to run the tests.
"Multi-drug resistant TB is a threat to every person on the planet," Harrington said. "It's not like HIV, where you are only infected through specific actions. TB is a threat to every person who takes a train or a plane."
Nev. clinic creates hepatitis C scare
Thu, 28 Feb 2008 01:47:06 GMTLAS VEGAS - A clinic may have infected a handful of patients with hepatitis C — but about 40,000 more should be tested for that virus, as well as for HIV, health officials said Wednesday.
Six people who underwent procedures at the Endoscopy Center of Southern Nevada now have the blood-borne hepatitis C virus, the Southern Nevada Health District said in a statement.
Five of them were treated the same day in late September; the sixth is believed to have been infected in July, the district said.
An investigation determined that "unsafe injection practices related to the administration of anesthesia medication might have exposed patients to the blood of other patients," the statement said.
Officials said the unsafe practices had been in place for several years and may have put others at risk. About 40,000 patients who received injections of anesthesia at the clinic will be told of the potential exposure in letters arriving next week.
Anyone who received anesthesia at the clinic from March 2004 to Jan. 11 should be tested for the virus, along with hepatitis B and HIV, chief health officer Lawrence Sands said.
"We are recommending all patients during this time frame to get tested because we cannot determine which patients may have been exposed," Sands said.
Hepatitis C is a chronic, potentially fatal virus that can cause liver ailments, including cancer and liver failure. The health district says it typically receives reports of two acute cases each year. Three of the six cases reported this year are acute, it said.
The virus may have been spread when clinic staff reused syringes and used a single dose of anesthesia medication on multiple patients, the district said.
Endoscopy Center of Southern Nevada has ceased those practices, it said.
"All concerns noted by the health department were addressed immediately. We want to be sure that every patient who may have been exposed is informed and tested," the center said in a statement.
To retain its state license and Medicare certification, the center faces increased on-site inspections and fines yet to be determined.
Overweight Hispanic Kids Show Early Markers for Diabetes
Thu, 28 Feb 2008 04:47:46 GMTWEDNESDAY, Feb. 27 -- A small U.S. study found that obese Hispanic children and adolescents with normal blood sugar levels had elevated markers for blood vessel inflammation that may put them at risk for both type 2 diabetes and cardiovascular disease.
Researchers at the Joslin Diabetes Center studied 38 Hispanic youngsters, aged 10 to 18. Of those, 17 were lean and 21 were obese but had normal blood sugar levels, which means they had not yet developed diabetes.
The obese children had significantly higher percentages of body fat than the lean children and were already showing signs of insulin resistance, a pre-diabetes condition.
The study also found that the obese children had higher levels of blood markers for subclinical, or asymptomatic, inflammation of the inner layer of blood vessels.
"They are already exhibiting problems with circulation. There is an inflammatory process going on in the vessels," lead investigator Dr. A. Enrique Caballero, director of Joslin's Latino Diabetes Initiative, said in a prepared statement.
The findings suggest the obese children may be at increased risk of developing cardiovascular disease at a young age, said Caballero, who is also an assistant professor of medicine at Harvard Medical School.
The study is published in the March issue of Diabetes Care.
Genetic and lifestyle factors put Hispanic children at high risk for developing type 2 diabetes, but they had not previously been studied, Caballero said.
"We have found that overweight Hispanic children and adolescents have elevated markers of endothelial dysfunction and vascular inflammation closely related to excess body fat and increased insulin resistance," the study authors concluded. "This ... may increase their risk of developing type 2 diabetes and cardiovascular disease, further emphasizing the need for obesity prevention strategies."
More information
For more on preventing diabetes, visit the American Diabetes Association.
UN wants new push against female circumcision
Wed, 27 Feb 2008 21:57:26 GMTBy Louis Charbonneau
UNITED NATIONS - Ten U.N. agencies launched a new campaign on Wednesday to end female genital mutilation, urging governments to help abolish a practice they said remained widespread in Africa, the Middle East and Asia.
"If we can come together for a sustained push, female genital mutilation can vanish within a generation," U.N. Deputy Secretary General Asha-Rose Migiro told an annual meeting of the U.N. Commission on the Status of Women.
"We call on member states to join us as full partners in this fight, to promote the end of this terrible practice, to respond to its consequences, and to hold those who perpetrate it criminally responsible for inflicting harm."
An estimated 100 million to 140 million women and girls worldwide are estimated to have undergone genital mutilation, also called female circumcision, with U.N. agencies estimating that another 3 million a year are subjected to it.
The practice usually involves cutting off the clitoris and other parts of the female genitalia. Many of the practitioners are untrained and use crude instruments.
Proponents of the ancient custom say it reduces female sexual desire, maintaining chastity before marriage and fidelity afterward. It can cause health complications and psychological damage and is sometimes fatal.
In a statement condemning the procedure, the U.N. agencies expressed concern that it has been in effect legitimized in some countries where is often done by medical professionals.
"The rate of decline in this practice leaves much to be desired," the statement said. "If we are to eliminate it, we must redouble our efforts." The campaign aims to eradicate the practice by 2015.
Last year the United Nations called for a worldwide ban on genital mutilation. The east African country of Eritrea, where the practice has been widespread, banned it in April 2007.
Egypt, where UNICEF estimates that some 97 percent of women between the ages of 15 and 49 have suffered the procedure, strengthened its ban last year by eliminating a legal loophole allowing girls to undergo the procedure for health reasons.
Genital mutilation predominantly occurs in 28 African countries, including Sudan, Chad, Sierra Leone and Djibouti, as well as in some Middle Eastern nations, parts of Asia, including Indonesia, and among immigrant communities in Europe and North America.
India mulls potentially landmark ruling on generic drugs
Thu, 28 Feb 2008 07:48:54 GMTby Parul Gupta
NEW DELHI - A drugs firm asked Indian officials for permission Thursday to make cheaper generic copies of cancer drugs for export to poor countries in a case watched closely by global pharmaceutical giants.
Indian firm Natco Pharmaceuticals made the plea for the country's first so-called "compulsory licence" to the patent office as it bids to make generic copies of Pfizer's Sutent and Roche's Tarceva cancer drugs.
"This is the first case in India. A compulsory licence will allow companies like ours to manufacture and export drugs to least developing countries," said M. Adinarayana, the secretary of Natco Pharmaceuticals, as the hearings began.
The global drugs patent system allows countries to make cheaper generic copies of patented drugs in certain situations, such as public health emergencies, under compulsory licences.
Experts said Natco's request for permission to make and export copies of Sutent and Tarceva to Nepal tested those regulations, amid a wider debate about whether poor countries have enough access to key but often pricey medicines.
Tarceva was granted a patent in India in 2007 following a new patent law passed in 2005, which brought the world's largest maker of generic drugs in line with World Trade Organisation guidelines on intellectual property.
The laxer rules before 2005 had encouraged generic drugs manufacture in India, which campaigners had welcomed as good for the poor.
Compulsory licences have been granted since 2005, but so far none have been issued in India, making Hyderabad-based Natco's plea a potentially landmark case.
Canada allowed a generic copy of a patented AIDS drugs to be exported to Rwanda in October. Thailand also issued domestic compulsory licences last year, but was criticised over claims it was not responding to a public health emergency.
An Indian Patent Office official, who declined to be named, said the hearing had started over the Roche case and that the Pfizer case would be held Friday. He expected representatives from Roche and Pfizer to attend.
Roche or Pfizer did not immediately respond to emailed requests for comment.
Many Indian activists have complained that the cost of patented drugs is too high and that provision should be made to allow generic drugs to be supplied to the country's legion of poor.
"If compulsory licensing is not resorted to, 98 percent of India's population will not be able to afford any of the patented drugs," said Y.K. Sapru, the president of the non-profit Cancer Patients Aid Association.
But pharmaceutical giants often argue protecting patents are crucial to stimulating the research and development of new drugs.
Industry groups object that if Natco is granted a compulsory licence for Nepal, then it could lead other Indian firms to push for more sales of generic drugs domestically.
Natco has reportedly offered Roche a five percent royalty on generic versions of Tarceva exported to Nepal, one of the world's poorest nations. The Indian firm stopped sales of an earlier generic copy of Tarceva after Roche won its 2007 patent.
But Indian firm Cipla, based in the financial capital Mumbai, started making a generic version of Tarceva a few months ago. Roche has filed a court case to halt further domestic sales by the firm.
One tablet of Tarceva, which fights lung cancer, costs about 4,800 rupees in India, where tens of thousands of people need the medicine. Cipla's generic copy sells for nearly one-third that price.
The cost difference is crucial for poor people, a Medecins Sans Frontieres official said.
"India is the only source for generic drugs for developing countries. It has the capacity to manufacture and has many generic producers," said Leena Menghaney, a campaigner for the group in India.
CDC Panel Urges Extending Flu Vaccine Coverage for Kids
Thu, 28 Feb 2008 04:47:41 GMTBy Steven Reinberg
HealthDay Reporter
WEDNESDAY, Feb. 27 -- U.S. health advisers recommended Wednesday that all children 6 months to 18 years of age receive annual flu shots.
Currently, the recommendation is that children 6 months to 5 years of age get vaccinated.
The recommendation by the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices would cover an additional 30 million children, making it one of the largest expansions of flu vaccination coverage in U.S. history.
The committee is recommending that the new guidelines take effect no later than the 2009-10 flu season, noting that many doctors have already ordered their vaccine for the 2008-09 season. The panel's recommendations are typically followed by the CDC, which issues vaccination guidelines to doctors and hospitals.
"Each season, many children remain vulnerable to the consequences of not being vaccinated against influenza," U.S. Surgeon General Dr. Richard H. Carmona said in a prepared statement. "We hope this expanded vaccination recommendation will strongly encourage Americans to get an annual influenza vaccination as soon as vaccine becomes available in their communities. This will help in reducing the number of childhood hospitalizations and deaths from influenza each season."
The flu kills dozens of U.S. children annually, part of the estimated 36,000 Americans who die each year from the disease. So far this season, there have been more than 10 reported deaths of children. During the 2006-07 flu season, 68 children died.
Children tend to come down with the flu at higher rates than adults but usually don't get as sick. Health officials hope that extending vaccine coverage will also benefit adults, making them less likely to be infected by children.
"Influenza is a serious, deadly illness that needs to have a vaccination each and every year," said Richard Kanowitz, president of Families Fighting Flu, who lost a 4-year-old daughter to influenza in 2004.
Kanowitz's group was one of those supporting expanding the age range for flu vaccination.
In 2006, the CDC expanded the recommendation to include children up to 5 years old.
"We want the recommendation expanded, because we hear even to this day people say, 'The recommendation doesn't apply to me. I don't have to get vaccinated.' It's completely the opposite," Kanowitz said. "You need to get vaccinated. The CDC just puts out a recommendation, and the confusion over whether people need to get vaccinated needs to be dispelled by having a clear message -- everyone should get vaccinated. The more people who get vaccinated, the more lives get saved."
This year's flu season has hit many areas of the country hard. Adding to the severity of the flu outbreak, this year's vaccine is not well matched to the current strains of flu most prevalent in the United States.
The virus strain most common in the United States right now is the influenza A H3N2 strain, and it's a strain not included in this year's vaccine. Also, this year's vaccine is not well-matched against influenza type B.
Complicating matters, some of this year's influenza type A virus is showing resistance to the antiviral drug Tamiflu. Overall, 8.1 percent of the influenza type A viruses tested by the CDC were resistant to Tamiflu. In past years, less than 1 percent of the viruses have been resistant to the drug.
Last week, the U.S. Food and Drug Administration selected the influenza strains that will make up the 2008-09 flu vaccine. Following the lead of the World Health Organization, the FDA is including the new flu strains Brisbane/10, a version of the H3N2 flu; a second new Type A strain known as H1N1/Brisbane/59; and a newer Type B/Florida strain.
But according to one expert, even the best planning may not result in a perfect vaccine.
"You have to make a decision about what will be in the vaccine in advance," said Dr. John Treanor, a professor of medicine, microbiology and immunology at the University of Rochester Medical Center in Rochester, N.Y. "It takes six to eight months to make the vaccine after you've chosen the strains.
"But the reality is that new strains emerge after that decision is made. So, you could be wrong," Treanor said.
More information
For more on flu vaccine, visit the CDC.
Ginkgo biloba may protect memory study
Thu, 28 Feb 2008 00:41:47 GMTNEW YORK - Taking the herbal supplement ginkgo biloba may help delay the onset of cognitive impairment in normal elderly adults, according to a study published online Wednesday.
However, the study also showed a higher incidence of strokes and "mini-strokes" in ginkgo users. The reasons for this are unclear and require confirmation in other studies, the investigators say.
Extracts of ginkgo biloba are among the most widely used dietary supplements. The herb is marketed as a memory enhancer, and some studies have suggested it may help improve memory and other mental functions in people with dementia.
"One of the most pressing public health problems facing our society is the rapidly growing number of people who, due to their age alone, are at high risk of developing dementia. The potential to delay or prevent this is of great importance," study chief Dr. Hiroko H. Dodge, from the Oregon State University in Corvallis, said in a statement.
The three-year study involved 118 people age 85 and older with no memory problems. Half of them took ginkgo biloba extract three times a day and half took a placebo.
During the study, 21 people developed mild memory problems, or questionable dementia: 14 of those took the placebo and 7 of those who took the ginkgo extract. Although there was a trend favoring ginkgo, the difference between those who took ginkgo and those who took placebo was not statistically significant.
However, when the researchers took into account whether people followed directions in taking the study pills, they found that people who reliably took ginkgo had a 68 percent lower risk of developing mild memory problems than those who took the placebo.
"These results need to be clarified with larger studies, but the findings are interesting because ginkgo biloba is already widely used, readily available, and relatively inexpensive," Dodge said.
As noted, more strokes and mini-strokes were seen in the ginkgo group. Seven people taking ginkgo had strokes, while none of those taking placebo did. "Ginkgo has been reported to cause bleeding-related complications, but the strokes in this case were due to blood clots, not excessive bleeding, and were generally not severe," Dodge noted in a statement.
"Further studies are needed to determine whether ginkgo biloba has any benefits in preventing cognitive decline and whether it is safe," he added.
SOURCE: Neurology, online February 27, 2008.
AstraZeneca39s Recentin fails lung cancer trial
Wed, 27 Feb 2008 09:10:05 GMTBy Ben Hirschler
LONDON - AstraZeneca Plc is stopping a clinical trial of Recentin as a treatment for lung cancer after a mid-stage study failed to meet its main goal, although trials in colorectal cancer will move ahead.
The mixed news on Wednesday adds to the company's patchy record on drug research, analysts said.
Recentin, which is given as a pill, is a rival to Roche Holding AG and Genentech Inc's blockbuster injectable treatment Avastin. It was being tested against non-small-cell lung cancer, the most common form of the disease.
The Anglo-Swedish drug maker said Recentin had shown some evidence of clinical activity in lung cancer but a Phase II/III trial would not progress into Phase III because among patients given the drug "there appeared to be an imbalance in toxicity."
John Patterson, the company's executive director for development, said AstraZenenca remained committed to investigating the potential of Recentin in lung cancer, despite the setback.
AstraZeneca, meanwhile, is progressing with a final stage Phase III clinical trial comparing Recentin plus chemotherapy with Avastin plus chemotherapy in colorectal cancer.
Shares in the drug maker were 0.3 percent lower at 20.01 pounds by 0825 GMT in a broadly unchanged market for drug stocks.
Navid Malik, a pharmaceuticals analyst at Collins Stewart, said lung cancer had potentially been the bigger commercial opportunity for Recentin, given there were already a number of competing drugs in colorectal cancer.
"Recentin was potentially a $1 billion product, so I think this is going to be quite disappointing for AstraZeneca," he said. "AstraZeneca needs good news from the pipeline."
AstraZeneca, which is facing the threat of generic competition to its two biggest sellers -- Nexium and Seroquel -- has suffered a series of setbacks with its new drug pipeline in recent years.
Back in 2001, AstraZeneca was the top-rated stock in the European sector but the failure of five key drugs -- Exanta, Iressa, Galida, NXY-059 and AGI-1067 -- and the risk from generics has pushed it into the bargain basement, trading at around 8.7 times forecast 2009 earnings.
Recentin, like Avastin, is a targeted cancer therapy -- a new class of medicine designed to fight tumours more effectively than chemotherapy, with fewer side effects. It targets three vascular endothelial growth factor receptors used by tumors to get blood supply.
AstraZeneca also has another similar experimental drug in development for lung cancer, called Zactima. Clinical trial results for this product are expected to read out in the coming months.
(Additional reporting by Mark Potter; Editing by Quentin Bryar/David Cowell)
