Archive for July, 2007



Transient amnesia can be a form of epilepsy (Reuters)

Monday, July 30th, 2007

Episodes of transient amnesia,
which frequently occur on awakening and are associated with
other memory problems, may be a symptom of a distinct type of
epilepsy. A British team describes this condition they call
"transient epileptic amnesia" in a study published in the
Annals of Neurology.

Dr. Adam Z. J. Zeman, of the Peninsula Medical School in
Exeter, and colleagues recruited 50 patients over an 18-month
period who had recurrent episodes of amnesia that were
witnessed by another person; otherwise intact mental
functioning; and evidence suggesting epilepsy, including EEG
abnormalities, response to anticonvulsant therapy; or clinical
features, such as hallucinations involving the sense of smell.

In correspondence with Reuters Health, Zeman described
transient epileptic amnesia as "repeated short episodes of
transient amnesia, occurring about once a month, usually
lasting about half an hour, often occurring on waking,
typically in middle-aged people around the age of 60."

"There can be other manifestations of epilepsy during the
attack, like a hallucination of a smell, or a brief period of
loss of awareness, but often the amnesia is the sole
manifestation of the seizure," he added.

Zeman’s team found that the condition was often
misdiagnosed — only 12 of the 50 patients in the study had
received an initial diagnosis of epilepsy.

Anticonvulsant medication was effective in 44 of the 47
patients treated. "Most of our patients were treated with
carbamazepine, sodium valproate or lamotrigine and the response
to treatment was generally excellent," Zeman said.

Among the 50 patients, 40 described persistent memory
difficulties. Patients demonstrated a "loss of autobiographical
memory for events extending back over 40 years." They had a
normal performance on standard memory tests, but they exhibited
"accelerated forgetting of verbal and visual material over
three weeks by comparison with matched control subjects," the
researchers report.

"We propose that transient amnesic epilepsy is a
distinctive epilepsy syndrome, typically misdiagnosed…and
associated with accelerated long-term forgetting and
autobiographical amnesia," Zeman and his colleagues conclude.

SOURCE: Annals of Neurology, June 2007.

(original article)

Nicotine may slow progression of rheumatoid arthritis (Reuters)

Monday, July 30th, 2007

In people with rheumatoid
arthritis, heavy cigarette smoking appears to slow the rate of
joint destruction, new research suggests.

"Potentially, this may be due to the anti-inflammatory
properties of nicotine," Dr. Axel Finckh, University Hospital
of Geneva, Switzerland told Reuters Health.

Cigarette smoking is a known risk factor for rheumatoid
arthritis, a chronic inflammatory disease that causes
progressive joint destruction, disability, and premature death,
Finckh and colleagues reported in the Annals of the Rheumatic
Diseases.

Yet, it remains unclear if smoking influences the
progressive joint destruction and disability cause by
rheumatoid arthritis. Finckh and colleagues therefore assessed
joint X-rays and results from self-reported functional
disability questionnaires for more than 2,000 rheumatoid
arthritis patients
in their early- to mid-fifties.

Most of the patients (1459) did not smoke; 489 were
considered moderate smokers and 55 were classified as heavy
smokers, consuming more than one pack per day.

Overall, the investigators found that the smokers and
non-smokers had similar rates of progressive joint damage and
functional disability.

Unexpectedly, they also found slower rates of progressive
joint damage in the X-rays of heavy cigarette smokers compared
with the moderate smokers and the non-smokers over the 3-year
study.

These findings suggest that smoking is more influential in
the development of rheumatoid arthritis than the progression of
the disease over time, but further research is needed to fully
understand the impact smoking has on disease progression.

Still, Finckh cautioned: "The cardiovascular hazards of
smoking
certainly outweigh the potential anti-inflammatory
benefits of nicotine," so the health risks associated with
smoking are much greater than any benefits people with
rheumatoid arthritis may gain from smoking.

Additional study is needed to understand the influence of
tobacco and nicotine on the body’s immune system.

SOURCE: Annals of the Rheumatic Diseases, July 2007.

(original article)

Generic drug prices skyrocketing in Canada: study (Reuters)

Monday, July 30th, 2007

Canadian government policies have
driven up prices of generic prescription drugs so dramatically
that they are more expensive than their U.S. counterparts, a
study showed on Tuesday.

Priceq of generic prescription drugs in Canada were, on
average, 115 percent higher than U.S. prices, a study by
Canada’s Fraser Institute showed. However, Canadian brand-name
prescription drugs
were about 51 percent cheaper than those in
the U.S.

"Canadians pay more for generic drugs because government
policies shield generic drug companies and pharmacy retailers
from normal market forces that would naturally reduce prices,"
the study said.

Indeed, generic drug prices in Canada have risen compared
with a similar study in 2005. At that time, they were 78
percent more expensive in Canada than in the U.S., while
Canadian brand-name drugs were 43 percent cheaper.

The institute said "misguided government policies" cost
Canadians between C$2.5 billion and C$6.6 billion in
unnecessary spending in 2006 alone, due to the inflated prices
for generic drugs.

From 2003 to 2006, the total in unnecessary spending was
estimated to be as high as C$20 billion, or possibly more than
C$26 billion, the report said.

The study showed that 44 percent of the prescriptions
dispensed in 2006 were for generic drugs, while 56 percent were
for brand-name drugs. In the U.S., 63 percent of prescriptions
were for generics with just 37 percent for brand-name drugs.

The report said Canadian drug programs direct public
reimbursement of prescriptions to pharmacies instead of
consumers, insulating consumers from the cost.

It said provincial drug programs reimburse generic drugs at
a fixed percentage of the brand-name original drug which
discourages price wars.

"Since the U.S. market is not distorted by the kinds of
government policies that exist in Canada, Americans benefit
from dramatically lower prices for generic drugs," Brett
Skinner, The Fraser Institute’s director of health,
pharmaceutical and insurance policy research, said in a
statement.

($1=$1.06 Canadian)

(original article)

Clinical Trials Update: July 31, 2007 (HealthDay)

Monday, July 30th, 2007

(HealthDay News) — Here are the latest clinical trials, courtesy of Thomson CenterWatch:

COPD (Chronic Obstructive Pulmonary Disease)

This study will compare the effectiveness of two investigational medications in people with COPD. The trial will last 35 days and require three clinic visits and at least one telephone call. Candidates must be at least 45 and have used the Spiriva HandiHaler.

The research site is in Panama City, Fla.

More information

Please see http://www.centerwatch.com/patient/studies/cat44.html.

—–

Diabetes Mellitus Types I and II

This study is for adults who are using metformin (Glucophage) to treat type 2 diabetes, but are having difficulty controlling blood sugar levels. If you qualify, the study may last up to 9 months, and you can continue taking current medications. All study related treatments and procedures are provided at no cost, and you may be compensated for time and travel. Health insurance isn’t required.

The research site is in Suffolk, Va.

More information

Please see http://www.centerwatch.com/patient/studies/cat55.html.

—–

Chronic Myeloid Leukemia

This study will evaluate the effectiveness and safety of an experimental drug, flavopiridol, in treating acute leukemias. Candidates with acute leukemias must be ages 1 to 17 years old to participate.

The research site is in Cincinnati, Ohio.

More information

Please see http://www.centerwatch.com/patient/studies/cat761.html.< /p>

—–

Copyright 2007 Thomson CenterWatch. All rights reserved.

(original article)

Doctor charged in transplant inquiry (Associated Press)

Monday, July 30th, 2007

The lawyer for a surgeon charged with prescribing excessive drugs to a disabled patient to speed up his death and harvest his organs says his client has been the subject of a “witch hunt.”

Prosecutors in San Luis Obispo County said Dr. Hootan Roozrokh, 33, of San Francisco, gave a harmful drug and prescribed excessive doses of morphine and a sedative to 26-year-old Ruben Navarro, who died in 2006.

Roozrokh was charged Monday in the first such criminal case against a transplant doctor in the U.S., the county district attorney’s office said.

M. Gerald Schwartzbach, Roozrokh’s lawyer, called the charges “unfounded and ill-advised,” saying his client “has unfairly been the subject of an 18-month witch hunt.”

“Nothing that Dr. Roozrokh did or said at the hospital that night adversely affected the quality of Mr. Navarro’s life or contributed to Mr. Navarro’s eventual death,” Schwartzbach said in a statement.

Roozrokh planned to surrender and post $10,000 bail, Schwartzbach said.

Navarro was taken in a coma to Sierra Vista Regional Medical Center, 150 miles northwest of Los Angeles, in 2006 after suffering respiratory and cardiac arrest. Although Navarro was found to have irreversible brain damage and was kept on a respirator, he was not considered brain dead because he still had limited brain function.

The day before Navarro died, his family gave approval for a surgical team to recover his organs for donation. That didn’t happen, however, because Navarro didn’t die within 30 minutes of being removed from life support. He died a day later.

Roozrokh, a surgeon at Kaiser Permanente’s now-closed kidney transplant program, was working at the time on behalf of a group that procures and distributes organs. The prosecutor’s office said in a statement that the drugs were prescribed “to accelerate Mr. Navarro’s death in order to recover his organs.”

State law prohibits transplant surgeons from being involved in the treatment of potential organ donors before they are declared dead.

Prosecutors did not pursue murder charges because witnesses said they did not believe the drugs caused Navarro’s death.

The coroner’s office this year determined Navarro died of natural causes. Last month, his mother, Rosa, filed a wrongful-death and medical malpractice lawsuit against Roozrokh and others, claiming her son was removed from life support without her permission and given lethal doses of drugs.

Navarro, who weighed about 80 pounds, was born with a neurological disorder known as adrenoleukodystrophy. He also had cerebral palsy and seizures.

Roozrokh was charged with felony counts of dependent adult abuse, administering a harmful substance and unlawful controlled substance prescription. If convicted of all three counts, he faces up to eight years in state prison or up to one year in jail and a $20,000 fine as a condition of probation.

(original article)

Two-Drug Combo Tough on Kidney Cancer (HealthDay)

Monday, July 30th, 2007

TUESDAY, July 31 (HealthDay News) — Kidney cancer might have met its match in a new combination of cancer drugs, a new study shows.

Used together, interferon alpha, a drug that boosts the body’s ability to fight off tumors and infections, and sorafenib, a drug that cuts off a tumor’s blood supply, led to significant tumor shrinkage in 33 percent of patients in a U.S. pilot study.

“We found that by combining a drug that enlists the immune system’s help in combating cancer with one that cuts off a tumor’s blood supply, we could substantially increase patients’ response rates to treatment,” lead investigator Dr. Jared Gollob, of the Duke Comprehensive Cancer Center in Durham, N.C., said in a prepared statement.

Used alone, each drug is only successful in fighting 5 percent to 10 percent of tumors. But the new study finds that the combination works much better. Sorafenib is sold under the brand name Nexavar.

The drugs had an additional benefit, the researchers said, in that the combo therapy doubled the time before tumors began to grow again. According to Gollob, most tumors begin growing again after about five or six months when treated by either drug alone.

Reporting in the Aug. 1 issue of the Journal of Clinical Oncology, Gollob and his research team gave 40 study patients sorafenib in pill form twice daily and interferon alpha injections three time a week for eight weeks. If the patient’s tumor had not grown or had shrunk after eight weeks, they repeated the cycle after a two-week break until the tumors disappeared or the cancer got worse. The researchers monitored the tumors using computerized-tomography (CT) scans.

The approach completely destroyed tumors in two of the 40 patients.

Researchers plan to begin a multi-site clinical trial that will analyze the impact of giving patients increasing doses of sorafenib alone after their tumors have shrunk as much as possible on the combination treatment.

According to the U.S. National Cancer Institute, about 51,000 people suffer from kidney cancer every year, and almost 13,000 will die from the disease. The majority of patients are men over the age of 45. The cancer is especially deadly, because it very rarely causes symptoms until it has reached an advanced stage. By the time kidney cancer rates stage IV status, it has spread to other organs such as lungs, liver and bones. People are given six months to two years to live once they reach stage IV, and only about 10 percent are alive five years after diagnosis.

The Duke team noted that one of the biggest challenges facing doctors and patients with kidney cancer is the cancer’s resistance to chemotherapy, radiation and other common cancer-fighting tools.

More information

To learn more about kidney cancer visit the cancer.gov/cancertopics/types/kidney” target=”_new”> U.S. National Cancer Institute.

(original article)

Health Tip: Red Face Could be Rosacea (HealthDay)

Monday, July 30th, 2007

(HealthDay News) — Rosacea is a condition in which the skin, most commonly on the face, breaks out in a red, bumpy rash.

Rosacea most often affects people after age 30, and is characterized by a pattern of flare-ups and remissions, says the National Rosacea Society.

Typical symptoms include persistent flushed face, red skin, bumps or pimples, and visible blood vessels. Eventually, the skin becomes ruddier. Fair-skinned people are especially prone to the condition, the society says.

The cause of rosacea is unknown, and there is no cure. Skin care with mild and gentle cleansers, as well as the use of cosmetics, can help minimize redness and other symptoms.

(original article)

Health Highlights: July 31, 2007 (HealthDay)

Monday, July 30th, 2007

Here are some of the latest health and medical news developments, compiled by editors of HealthDay:

U.S. Chief Justice Hospitalized After Seizure at Maine Summer Home

Chief Justice John Roberts suffered a seizure Monday at his summer home on a Maine island and was hospitalized overnight for observation, according to spokespersons for the U.S. Supreme Court and the Penobscot Bay Medical Center, where he was taken.

The Supreme Court statement said the chief justice, 52, was “fully recovered” from the 2 pm seizure and had undergone “a thorough neurological evaluation, which revealed no cause for concern.” He was kept overnight as “a precaution,” The New York Times reported.

The newspaper noted that this was the second recorded seizure suffered by Roberts; the first occurred in 1993. This one was described as a benign idiopathic seizure, the newspaper reported, which means that the cause is unknown. A U.S. Supreme Court press release said the 1993 seizure was similar to the one that occurred Monday.

According to the Associated Press, the court press release said that Roberts “experienced minor scrapes” when he fell after the seizure.

Roberts was “conscious and alert” when he was taken off the boat from his island home at Port Clyde and put in the ambulance, St. George fire chief Tim Polky told the AP.

The wire service and the Times interviewed a number of medical experts who concluded that the diagnostic equipment at Penobscot Bay Medical Center was sufficient for initial testing, but that, after having gone through two seizures, the chief justice probably would need to be evaluated to determine whether further treatment was necessary.

Dr. David J. Langer, the director of cerebrovascular neurosurgery at St. Lukes-Roosevelt, Beth Israel and Long Island College Hospital in New York told the Times that if Roberts began taking medication to control future seizures, it could “have significant side effects.”

And Dr. Edward Mkrdichian, a neurosurgeon at the Chicago Institute of Neurosurgery and Neuroresearch, told the AP that anyone who has had two unexplained seizures was at high risk for a third. Mkrdichian said he prescribes anti-seizure medications for those patients.

—–

Capsules May Help Prevent Insulin Cell Transplant Rejection

Results from experiments with mice and pigs suggest that implanted capsules made from seaweed and iron may help prevent insulin cell transplant rejection in people with Type 1 diabetes, says a Johns Hopkins University study.

The capsules, which contained insulin cells, were placed in the pancreas of diabetic mice and in the liver of the pigs, the Associated Press reported. Openings in the porous capsules were large enough to allow the release of insulin into the body, but too small for immune cells to enter and attack the insulin cells.

Blood sugar levels of mice that received the capsules returned to normal within about a week. In pigs, the capsules were still releasing usable levels of insulin after three weeks. The findings were published online Sunday in the journal Nature Medicine.

These capsules may reduce the need for anti-rejection drugs in Type 1 diabetes patients who receive insulin cell transplants, study co-author Jeff Bulte, professor of radiology and chemical and biomolecular engineering, told the AP.

The team of researchers are starting a longer-term trial of the capsules in pigs and are partnering with a private company to begin the process of seeking U.S. Food and Drug Administration approval for the capsules.

—–

Second U.S. Hospital to Offer Partial Face Transplants

Brigham and Women’s Hospital in Boston says it has granted permission to a surgical team to perform partial face transplants on certain patients with serious facial disfigurement, the Boston Globe reported.

The hospital said it would allow the procedure only for patients already taking immunosuppressant drugs, which reduce the risk of tissue rejection and infection.

Dr. Bohdan Pomahac, associate director of the burn unit at Brigham and Women’s, said that he has seen four patients in recent years who might qualify for the procedure, the Globe reported.

Only one other U.S. hospital — the Cleveland Clinic — has announced that it would offer partial face transplants. So far, three such procedures have been reported worldwide, two in France and one in China.

—–

Major Dengue Fever Outbreak Hits Asia

An outbreak of mosquito-borne dengue fever in Asia could prove the worst to hit the region in nearly a decade, says the World Health Organization.

The disease is erupting in a number of countries. In Cambodia, nearly 25,000 people have been diagnosed with dengue fever (about three times the number of cases for all of 2005) and nearly 300 children have died, the Associated Press reported.

In Indonesia, more than 100,000 cases of dengue fever and 1,100 deaths have been reported this year. In Malaysia, more than 1,000 dengue fever patients have been admitted to hospitals every week for the past month. Vietnam has reported more than 33,000 cases and 32 deaths so far this year.

In 1998, there were about 350,000 cases of the disease and nearly 1,500 deaths in Southeast Asia, the AP reported. The current outbreak could reach similar levels, said John Ehrenberg, WHO’s regional adviser on vector-borne diseases.

There are no vaccines or cures for the four different types of dengue fever, which causes high fever, joint pain, nausea, rashes, and severe headache.

—–

Alcohol Increases Bowel Cancer Risk: Study

The more alcohol you drink, the more likely you are to develop bowel cancer, says a British study that found that a large glass of wine or a pint of beer a day increases the risk by about 10 percent, while those who drink more than 30 grams of alcohol a day have a 25 percent increased risk.

The study authors analyzed data on almost 480,000 people, who were asked how much alcohol they drank and then were followed for six years, BBC News reported. During that time, 1,833 of the study volunteers developed bowel cancer. The findings appear in the International Journal of Cancer.

“The research shows quite clearly that the more alcohol you drink the greater your risk of bowel cancer,” said Professor Tim Key, a Cancer Research UK epidemiologist and deputy director of the cancer epidemiology unit in Oxford.

“The increase in risk is not large but it is important that people understand they can reduce their risk of a number of different cancers — including bowel cancer — by cutting down on alcohol,” Key said.

(original article)

Health Tip: Use Your Inhaler Correctly (HealthDay)

Monday, July 30th, 2007

(HealthDay News) — People with asthma are often prescribed a metered-dose inhaler. It is important to know how to use an inhaler correctly to ensure that you get the proper amount of medicine to help you breathe.

Here are some guidelines from the American Academy of Family Physicians:

  • Remove the cap and shake the canister, holding it upright.
  • Slightly tilt your head backward, and exhale.
  • Hold the inhaler an inch or so from your mouth, in your mouth with a spacer, or place the inhaler directly in your mouth.
  • As you slowly inhale for three to five seconds, press down on the top of the inhaler.
  • Hold your breath for about 10 seconds to allow the medicine to fill your lungs.
  • Repeat these steps if directed by your doctor.

(original article)

1 Joint as Damaging as 5 Cigarettes to Your Lungs (HealthDay)

Monday, July 30th, 2007

TUESDAY, July 31 (HealthDay News) — Smoking just one marijuana joint is the same as smoking five cigarettes in terms of the damage it does to your lungs, a new study found.

Lung damage from marijuana results in chronic bronchitis and other respiratory problems. But whether marijuana causes emphysema or lung cancer isn’t clear, the researchers said.

“This damage is a full range from symptoms to structural lung damage and reduced lung function,” said lead researcher Dr. Richard Beasley, director of the Medical Research Institute of New Zealand, in Wellington.

Beasley thinks marijuana smokers should heed the study’s findings. “Many people think that marijuana is safe, but this shows that it’s not safe. Hopefully, this will avoid a lack of knowledge among smokers,” he said.

For the study, Beasley’s group collected data on 339 people. The group consisted of people who smoked at least one marijuana cigarette a day for five years; people who smoked a pack of tobacco cigarettes a day for at least a year; and people who smoked both. There were also people who didn’t smoke either tobacco or marijuana.

All the study participants had lung X-rays and took breathing tests to see how well their lungs worked, according to the July 31 online report in the journal Thorax.

Among the 75 people who smoked only marijuana or the 91 who smoked tobacco and marijuana, there were complaints of wheezing, coughing, chest tightness and phlegm. But, the researchers found signs of emphysema only among the people who smoked just tobacco or tobacco in combination with marijuana.

Marijuana did, however, damage the lungs and stopped them from working properly. The drug decreased the number of small fine airways, which carry oxygen and waste products to and from the blood vessels. In addition, marijuana damaged the large airways, blocking airflow and making the lungs work harder, the researchers found.

The amount of damage was directly related to the number of joints smoked, with more marijuana associated with more lung damage, Beasley noted.

The extensive damage from marijuana results from its higher burn temperature, and because it is inhaled more deeply and held in the lungs longer than cigarettes, Beasley explained. “In addition, there is no filter,” he said.

One expert thinks this study is the first to really explain the risks to the lungs posed by marijuana.

“We have always suspected that marijuana causes lung damage, but it’s nice to have it quantified,” said Dr. Norman Edelman, chief medical officer at the American Lung Association. “Now we can say much more strongly, to people who smoke marijuana, that they are doing bad things to their lungs.”

There are still many unanswered questions about marijuana smoking, Edelman said. “Do marijuana smokers go on to get chronic obstructive pulmonary disease?” he asked. “We don’t know that.”

More information

For more about marijuana, visit the U.S. National Institute on Drug Abuse.

(original article)

Diabetes Drug Should Stay Despite Heart Risks, U.S. Advisers Say (HealthDay)

Monday, July 30th, 2007

MONDAY, July 30 (HealthDay News) — The widely prescribed type 2 diabetes drug Avandia should remain on the market, despite studies that suggest it could increase the risk of heart attacks, U.S. health advisers said Monday.

The U.S. Food and Drug Administration advisory panel voted 22-1 to keep the drug on the market, although it recommended Avandia should carry new safety warnings. That vote was preceded by another vote, 20-3, in which panel members agreed that available data does show Avandia increases heart risks.

“The committee felt, almost uniformly, that there is a risk to some patients,” said Dr. Clifford Rosen, the acting committee chairman from the Maine Center for Osteoporosis, St. Joseph Hospital, in Bangor.

“There was some increased risk of cardiac events to some patients. The signal for increased risk was there, with some qualifications,” he told reporters at a teleconference.

Patients at risk include those with congestive heart failure, heart disease or patients using insulin, Rosen said, adding, “There are clear-cut reasons not to prescribe this drug to certain patients.”

But the decision to keep the drug on the market, according to an FDA official, came about because the committee wasn’t convinced that the data presented about the risk was conclusive.

“If we have a clear answer, we don’t take this to an advisory committee,” Dr. Robert Meyer, the director of the FDA’s Office of Evaluation II, Center for Drug Evaluation and Research, told reporters.

Dr. Gerald Dal Pan, director of the FDA’s Office of Surveillance and Epidemiology, said, “We will go back and formulate what we think should be on the label.” Panelists’ suggestions included a black box warning or other warning for heart attack, but there was no consensus on how the label should be changed, he said.

The FDA had previously asked GlaxoSmithKline to add a black box warning about heart failure.

While the FDA isn’t bound to follow the recommendations of its advisory panels, it typically does so.

Concerns about Avandia (rosiglitazone), part of a class of drugs for diabetes called thiazolidinediones, are based on a meta-analysis of published studies that suggested the drug increases the risk of heart attack by 43 percent.

That finding was first published May 21 in the New England Journal of Medicine, in a paper co-authored by Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic and one of the earliest critics of the arthritis drug Vioxx, which was withdrawn from the market in 2004 due to heart attack concerns.

Dr. Larry Deeb, president for medicine and science at the American Diabetes Association, said before Monday’s vote that he believes Avandia should continue to be available to diabetics because the increased risk of heart attack has not been proven conclusively.

“A decision to do something should not be based on a nebulous risk,” Deeb said. “There probably should be a warning on the box, because there is enough concern.”

Deeb believes the FDA should call for a study to thoroughly review any heart risks associated with the drug’s use. “It’s premature to withdraw the drug. I am anxious about pulling [a drug] that has done some good off the market based on a meta-analysis,” he added.

Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, who has previously spoken out against Avandia, was among the speakers at the hearing. “Does the overall risk-benefit profile of Avandia support its continued marketing in the United States? The answer is clearly no,” he said in a prepared statement.

According to Wolfe’s prepared testimony, FDA adverse-reaction reports filed since Avandia hit the market in 1999 have shown the drug had a 15.2 times higher adjusted rate of heart failure than did the older diabetes drug Glucotrol. The adjusted rate of liver toxicity with Avandia was 9.5 times higher, and 14.8 times higher for liver failure, he said.

“There is no evidence of any uniquely beneficial clinical outcome for Avandia and growing evidence of unique risks in multiple organ systems,” Wolfe said. “If Avandia were up for approval today, based on what is now known, it would be summarily rejected. There should not be a double standard for removing it from the market.”

For its part, Avandia’s maker, GlaxoSmithKline, insists the drug does not increase the risk of heart attack. “We don’t believe that a warning about heart attack should be on the label,” said Dr. Andy Zambanini, director of clinical development at GlaxoSmithKline.

“Avandia is one of the most studied medicines in the diabetes field,” Zambanini said. “We have looked at all the available data both from short-term trials, long-term trials and real-world data, in terms of epidemiology. There is really no evidence of an increase in cardiovascular death with Avandia. And when you look at Avandia and compare it with all the other similar agents, there really is no difference in heart attack risk.”

One of the studies that GlaxoSmithKline is relying on to make its case is the RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes) trial. The study, sponsored by Glaxo, was specifically designed to determine the risks for heart attack from Avandia.

Dr. David Graham, associate director for science and medicine in the FDA’s Office of Surveillance and Epidemiology and an Avandia critic, disagreed with Glaxo’s interpretation of the RECORD study. In a report submitted by the FDA to the advisory panel before the hearing, Graham concluded:

“RECORD does not now, nor will it at completion, provide meaningful evidence to demonstrate with any degree of certainty that RSG [Avandia] does not increase the risk of acute myocardial infarction [heart attack] or sudden death, or the APTC outcome. The biased design of RECORD renders it useless as an objective measure of Avandia’s cardiovascular safety.”

Zambanini countered by saying that the RECORD study has seen very few cardiac deaths. “To say that this study is of no value isn’t true,” he said.

During Monday’s testimony, Graham was supported by his boss, Dal Pan, who said the risks posed by Avandia outweighed the benefits.

But another agency official, Dr. Robert Meyer, head of the FDA office that reviews new diabetes drugs, urged panel members to keep an open mind about Avandia, the AP reported.

“It is important that the committee understand there is a fundamental disagreement within (the FDA’s drugs office) on the scientific conclusions that should be drawn,” Meyer said.

That rift revealed a division between FDA officials responsible for approving new medicines and those who monitor their safety once on the market, the AP said.

More than 2 million people worldwide take Avandia for type 2 diabetes, the most common form of diabetes in which the body doesn’t produce enough of the hormone insulin or cells ignore the insulin, leading to a buildup of blood sugar that can pose a range of health risks. Obesity is often a cause of type 2 diabetes. The drug generates $3.2 billion in annual sales for GlaxoSmithKline.

Currently, there is a warning on Avandia’s label that it increases the risk of another cardiovascular problem called congestive heart failure, a chronic condition caused by the heart’s failure to pump normally, allowing fluid to build up in the body.

In May, the FDA said it wanted a stronger warning about the risk of heart failure on Avandia’s label. Glaxo is “still in negotiation with the FDA about a new warning label on heart failure and we expect to release that information soon,” Zambanini said.

Critics of the drug contend there are alternatives to Avandia that don’t have the same risk for heart failure or heart attack They include metformin, Actos, Amaryl, Glyburide and others.

More information

Learn more about diabetes drugs from the diabetes/pills.html” target=”_new”>U.S. Food and Drug Administration.

(original article)

India to step up fight against HIV in children (Reuters)

Monday, July 30th, 2007

India launched a drive on Tuesday to
supply drugs to tens of thousands of mothers and newborns to
stop HIV transmission to infants.

India has the world’s third highest HIV caseload, after
South Africa and Nigeria, with around 2.5 million people living
with the virus — of whom around 70,000 are under 15 years old.

The government said at least 21,000 children are infected
each year through mother-to-child transmission of the virus.

&quot;One of the constraints is the higher number of home
deliveries, making access a problem,&quot; said Health Secretary
Naresh Dayal, at the launch of an anti-AIDS policy aimed at
pregnant women, mothers and children.

More than half of Indian women deliver at home, the vast
majority without help from medical professionals.

Since its first reported HIV case in 1986, the Indian
government has given drugs to around 20,000 women and newborns
to prevent HIV transmission.

Officials say they aim to push up the number to nearly
76,000 by 2010 by expanding health services in rural areas in
order to determine the HIV status of a greater number of
pregnant women.

If untreated, roughly one-in-four newborns get the virus
from their infected mothers, either during birth or soon after.

Across the world, around 2.3 million children are living
with HIV.

Yet only around 10 percent of those who need treatment
receive it, UNICEF says, adding that the others face a &quot;bleak
and short-lived future.&quot;

India is providing around 6,500 children with pediatric
drugs to combat HIV and says is involved in the &quot;difficult
task&quot; of trying to identify thousands more who may be in need
of drugs.

It is also planning to introduce long-pending legislation
this year to prevent HIV discrimination, as several cases of
schools refusing admission to HIV-positive children or asking
those enrolled to leave have been reported.

Other children have been told by relatives they would not
inherit family property because of their HIV status.

&quot;Anybody who hesitates to reach out to somebody with HIV is
truly ignorant and should be labeled as such,&quot; Women and Child
Development Minister Renuka Chowdhury said.

(original article)

One cannabis joint as bad as five cigarettes: study (Reuters)

Monday, July 30th, 2007

Smoking one cannabis joint is as harmful
to a person’s lungs as having up to five cigarettes, according
to research published on Tuesday.

Those who smoked cannabis damaged both the lungs’ small
fine airways, used for transporting oxygen, and the large
airways, which blocked air flow, the researchers said.

It meant cannabis smokers complained of wheezing, coughing,
and chest tightness, the study by experts at the Medical
Research Institute of New Zealand found.

The researchers tested 339 people — those who smoked only
cannabis, those who smoked tobacco, those who smoked both and
non-smokers.

The study found only those who smoked tobacco suffered from
the crippling lung disease emphysema, but cannabis use stopped
the lungs working properly.

&quot;The extent of this damage was directly related to the
number of joints smoked, with higher consumption linked to
greater incapacity,&quot; said the authors of the report published
in the medical journal Thorax.

&quot;The effect on the lungs of each joint was equivalent to
smoking between 2.5 and five cigarettes in one go.&quot;

The British government is considering whether cannabis
should be reclassified as a more serious drug because of the
dangers associated with stronger strains.

&quot;The danger cannabis poses to respiratory health is
consistently being overlooked,&quot; said Helena Shovelton, Chief
Executive of the British Lung Foundation.

&quot;Smoking a joint is more harmful to the lungs than smoking
a cigarette and we have just banned people from doing that in
public places because of the health risks.&quot;

Last week British researchers said using marijuana
increased the risk of developing a psychotic illness such as
schizophrenia.

(original article)

Experimental Therapy Reverses Type 1 Diabetes in Mice (HealthDay)

Monday, July 30th, 2007

MONDAY, July 30 (HealthDay News) — Researchers have accomplished what might be a cure of type 1 diabetes — at least in mice — and they’re taking the first steps toward a human trial.

Type 1 diabetes is the autoimmune form of the disease, affecting about five percent of diabetics. It usually emerges in childhood and occurs when the body’s immune system attacks insulin-producing beta cells in the pancreas.

Now, a three-drug regimen that not only stops the destruction of beta cells but also preserves the function of cells that receive and metabolize insulin has eliminated type 1 diabetes in laboratory mice, said lead researcher Maria Koulmanda, director of nonhuman primate research at the Transplant Research Center, Beth Israel Deaconess Medical Center in Boston.

Her team published its report July 30 in this week’s online edition of the Proceedings of the National Academy of Sciences.

“We stopped the progression of automimmunity. The animals could become normoglycemic,” meaning they had normal levels of blood sugar, Koulmanda said.

Another major discovery is that inflammation appears to play a major role in type 1 diabetes, she added. In fact, one drug used in the treatment regimen reduced the inflammation of cells that metabolize insulin.

“Basically, by blocking inflammation, we were getting the animals to be insulin-sensitive,” Koulmanda said.

Another drug successfully reduced the autoimmune destruction of beta cells, but that was not the key to reversing the disease, she said. Instead, success was linked to blocking inflammatory processes that impair cells’ responses to insulin.

Some of the cells involved in insulin metabolism were found to be resistant to insulin’s effects — a common phenomenon seen in much more common, adult-onset, obesity-linked type 2 diabetes, Koulmanda said. “This is the first time anyone has seen insulin-resistant cells in type 1 diabetes,” she noted.

A course of treatment lasting less than four weeks restored normal blood sugar function in the test mice. In contrast, mice that did not get the treatment died during that month-long period.

Based on these promising results, the first work need to start a human trial of the regimen are about to begin, said Dr. Terry B. Strom, director of the Transplant Research Center.

“We have tried something like this for monkey models,” he said. “The results have been very good.”

The next step will be tests to ensure that the regimen is safe for human use.

“We anticipate toxicology trials very soon,” Strom said. “We are making the proteins needed for those trials.”

The fact that success was achieved in the mice trials with a relatively short course of treatment indicates that, for humans, “one might be able to use relatively brief periods of treatment to restore normal function,” he said.

More information

There’s more on type 1 diabetes at the diabetestype1.html” target=”_new”>U.S. National Library of Medicine.

(original article)

One-Third of Diabetics Have Sleep Apnea (HealthDay)

Monday, July 30th, 2007

MONDAY, July 30 (HealthDay News) — People with type 2 diabetes who drag themselves through the day may be among the 36 percent of diabetics suffering from obstructive sleep apnea, according to new research.

Sleep apnea occurs when impaired breathing due to collapsed airways triggers multiple nighttime awakenings.

Researchers at The Whittier Institute for Diabetes in La Jolla, Calif., analyzed health data from 279 adults with type 2 diabetes. They found that one out of three diabetics also suffered from obstructive sleep apnea. Men, particularly those over the age of 62, were more than twice as likely as women to experience interrupted sleep.

Previous research has indicated a relationship between obstructive sleep apnea, glucose intolerance and insulin resistance, so the connection with type 2 diabetes is not surprising. This is the first study to analyze data from both men and women at a diabetes clinic, the researchers said.

“These findings demonstrate that obstructive sleep apnea has a high prevalence in adults with type 2 diabetes,” principal investigator Dr. Daniel Einhorn said in a prepared statement. “Given that treatment of obstructive sleep apnea has the potential to both decrease blood pressure and improve glycemic [blood sugar] control, individuals with type 2 diabetes should be regularly screened for the presence of sleep apnea,” he said.

The researchers published their findings in the current issue of Endocrine Practice.

According to previous research, treating people who have both obstructive sleep apnea and type 2 diabetes with “continuous positive airway pressure” therapy not only helps manage the sleep interruptions but also reduces blood sugar levels. The researchers recommend that clinicians screen patients with type 2 diabetes for obstructive sleep apnea.

According to the American Diabetes Association, more than 20 million people in the United States have diabetes, with more than one in five adults over the age of 60 suffering from the disease. Type 2 is the most common form of diabetes, a disease in which the body does not make or use insulin effectively.

The National Sleep Foundation estimates that more than 18 million people suffer from obstructive sleep apnea, although the majority of people have not been diagnosed with the disorder. Obstructive sleep apnea is related to a multitude of health risks, including heart disease, high blood pressure, depression, sexual dysfunction and an increased risk of car accidents.

More information

To learn more about obstructive sleep apnea, visit the National Sleep Foundation.

(original article)


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