FDA expands warnings on anemia drugs
Sat, 08 Mar 2008 03:55:25 GMT
By MATTHEW PERRONE, AP Business Writer
WASHINGTON - Drug maker
Amgen Inc. said Friday it expanded black box warnings about risks of death and tumor growth of its blockbuster anemia drugs.
The warnings approved by the
Food and Drug Administration state that the company's drugs increased death and accelerated tumor growth in patients with early
stage breast cancer and cervical cancer. Earlier labeling warned of similar risks in other types of cancer.
The changes apply to
Thousand Oaks, Calif.-based
Amgen's Aranesp and Epogen, as well as
Johnson & Johnson's Procrit. The drugs treat the blood-disorder anemia in patients with
kidney failure and those on chemotherapy. Amgen manufacturers all three, though New Brunswick, N.J.-based J & J sells Procrit.
The language states that the problems occurred when doctors treated patients with elevated levels of the drugs, which increase red blood cell levels.
The action came less than a week before a meeting where government advisers are scheduled to review the risks of the blockbuster medications.
Since
FDA began scrutinizing the drugs last March, shares of Amgen have sunk 27 percent. U.S. sales of its anemia treatments fell more than 10 percent to $6.3 billion for the year.
Wall Street analysts expect sales to fall further in 2008 following next week's review by FDA's cancer experts. The panel could recommend halting use of the drugs for certain types of cancers, or in all cancer patients. Recommendations will not apply to Amgen's Epogen, which is used almost exclusively by
kidney failure patients on dialysis.
If FDA removes only some cancer indications, Amgen's
anemia drug sales could lose between $150 million to $250 million for 2008, according to estimates by
Goldman Sachs' analyst May-Kin Ho.
FDA twice updated anemia drug labels last year, most recently in November. Amgen disclosed new data in December on the drugs' risks in early stage breast cancer and cervical cancer patients, sending shares downward nearly 20 percent. The new label incorporates detail from those studies.
Bear Stearns analyst Mark Schoenebaum said the effect of Friday's changes would be minimal for Amgen, since cervical cancer accounts for about 1 percent of the Aranesp market. He also noted that the previous label already highlighted the
breast cancer risks.
But
Stanford Group Co. analyst Gregory Frykman said the new warnings could attract tougher regulations from Medicare, the government's health plan for seniors. Last summer Medicare ruled that it would only pay doctors to administer anemia drugs if they were prescribed at low levels.
Frykman said the new warnings could convince Medicare to scale back its policy again, perhaps only paying for the drugs when used in certain types of cancer.
Wall Street reacted positively to the news, sending shares up 1.02 cents, or 2.3 percent, to $45.20 in after-hours trading. Shares fell 14 cents to close at $44.18 in regular trading.
Parents speak out on vaccine settlement
Fri, 07 Mar 2008 22:43:13 GMT
By MIKE STOBBE, AP Medical Writer
ATLANTA - The parents of a girl who won a government settlement described how their hearts were broken as they watched their healthy, red-haired toddler transformed into an irritable, odd-behaving child after she got several childhood shots.
"Suddenly my daughter was no longer there," said Terry Poling, the girl's mother, in a news conference Thursday. She and her husband Jon said their daughter Hannah, now 9, has been diagnosed with autism.
The government has agreed to pay the Polings from a federal fund that compensates people injured by vaccines. The amount of the settlement hasn't been set yet. U.S. officials reject the idea that vaccines cause autism, but they say that in this case the shots worsened an underlying disorder that led to autism-like symptoms.
The Polings said five simultaneous vaccinations in July 2000 led to Hannah's autistic behavior. She was about 18 months at the time.
U.S. health officials have consistently maintained that vaccines are safe, and the head of the Centers for Disease Control and Prevention said Thursday that there was no change in that position.
"Nothing in any of this is going to change any of our recommendations" about the importance of vaccines for children, said Dr. Julie Gerberding. "Our message to parents is that immunization is lifesaving."
In the Polings' first appearance since their case became public this week, the
Athens, Ga., couple acknowledged their legal case never got to the point where evidence was argued.
They called on the government to remove thimerosal — a mercury-based vaccine preservative — from all flu shots. Thimerosal has already been removed from other vaccinations given to children.
"Why take a chance?" asked Jon Poling, a 37-year-old neurologist.
The Polings, accompanied by Hannah, said that as a toddler, their daughter was a bright child who could whistle on command. But almost immediately after the vaccinations nearly eight years ago, she became feverish and irritable. Then, her behavior gradually changed so she would stare at fans and lights and run in circles.
"It wasn't like a switch being turned off. It was more like a dimmer switch being turned down," Jon Poling said.
Government health officials conceded that the vaccines exacerbated an underlying condition and that she should be paid from the federal vaccine-injury fund.
Autism advocates called Hannah's case a "landmark decision," although the Polings' own attorney disputes that.
"This was not a court decision," said Clifford Shoemaker, who is based in
Vienna, Va. The U.S.
Department of Health and Human Services conceded the case before the court was asked to make a determination, he added.
Government officials wouldn't discuss why they conceded this particular case, but said people with pre-existing disorders can obtain compensation under the program if they establish that their underlying condition was "significantly aggravated" by a vaccine.
Medical and legal experts say the narrow wording and circumstances probably make the case an exception — not a precedent for thousands of other pending claims.
"This does not represent anything other than a very special situation," said the
CDC's Gerberding.
Hannah has a disorder involving her mitochondria, the energy factories of cells. The disorder — which can be present at birth from an inherited gene or acquired later in life — impairs cells' ability to use nutrients. It often causes problems in brain functioning and can lead to delays in walking and talking.
Experts argued over how common the disorder is, and by implication, how many other vaccine cases might be affected.
"Most children with autism do not seem to have a mitochondrial problem, so this association ... is probably relatively rare," said Dr. Edwin Trevathan, a pediatric neurologist who heads the CDC's birth defects center.
The United Mitochondrial Disease Foundation, a
Pittsburgh-based group that raises money for research, says there are more than 100 types of mitochondrial disease, and genetic tests can find only a couple dozen.
The Polings were exploring two theories about what happened to Hannah. One is that she was born with the mitochondria disorder and the vaccines caused a stress to the body that worsened the condition. The other was that the ingredient thimerosal caused the mitochondrial dysfunction, Jon Poling said.
Since 2002, the preservative thimerosal has been removed from shots recommended for young children, except for some flu shots.
___
Medical Writer Marilynn Marchione in
Milwaukee contributed to this report.
___
On the Net:
CDC Autism Information Center: http://www.cdc.gov/ncbddd/autism/
United Mitochondrial Disease Foundation:
http://www.umdf.org/site/c.dnJEKLNqFoG/b.3041929/
Analysis Vaccineautism link unproven
Fri, 07 Mar 2008 22:44:05 GMT
By MIKE STOBBE and MARILYNN MARCHIONE, AP Medical Writers
ATLANTA - For those convinced that vaccines can cause autism, the sad case of a Georgia girl, daughter of a doctor and lawyer, seems like clear-cut evidence. The government has agreed to pay the girl's family for injury caused by vaccines. But it turns out it's not that simple — and maybe not even a first. The 9-year-old girl, Hannah Poling, had an underlying condition that may have been worsened, triggering her autism-like symptoms.
Her parents believe it was the five simultaneous vaccines she got as a toddler in one day eight years ago that did it. Government scientists say something like a fever or infection could have set off the problem — but they didn't rule out the vaccines either.
This week, government officials said they have agreed to pay the Polings from a federal fund that compensates people injured by vaccines. The amount is not yet determined.
While parents and advocates for autistic children say the case is a landmark legal precedent that signals the government is finally conceding potential autism-related risks from childhood vaccines, government officials are saying it's nothing of the kind.
"This does not represent anything other than a very special situation," said Dr. Julie Gerberding, head of the
U.S. Centers for Disease Control and Prevention.
Her comments came after the Polings, from
Athens, Ga., held a news conference Thursday to talk about their daughter, who accompanied them. At the briefing, Hannah seemed socially engaged with her caregiver, but later in an appearance on CNN's "
Larry King Live," she was quiet and seemed to be in her own world.
As a toddler, they said she was a bright, normal-behaving child until she got five shots when she was about 18 months old. She was a little behind on her vaccinations, so the decision was made to give her five shots.
Almost immediately after, she was screaming, feverish and irritable. Then, her behavior gradually changed so she would stare at fans and lights and run in circles.
"It wasn't like a switch being turned off. It was more like a dimmer switch being turned down," said Hannah's father, Jon, a 37-year-old neurologist.
It was heartbreaking, said her 47-year-old mother, Terry, who is trained as both a lawyer and a nurse.
"Suddenly my daughter was no longer there," she said.
The family filed a claim with the federal vaccine compensation program in 2002, which the government ultimately decided to concede before any evidentiary hearing.
The case may not be a first, said Gary Golkiewicz, chief special master for the U.S. Court of Federal Claims. He oversees the special "vaccine court" which rules on requests for payments from the vaccine injury fund.
"Years ago, actually, I had a case, before we understood or knew the implications of autism, that the vaccine injured the child's brain caused an encephalopathy," he said. And the symptoms that come with that "fall within the broad rubric of autism."
And there are other somewhat similar cases, Golkiewicz says, that were decided before autism and its symptoms were more clearly defined.
Hannah has a disorder involving her mitochondria, the energy factories of cells. The disorder — which can be present at birth or acquired later in life — impairs cells' ability to use nutrients. It often causes problems in brain functioning and can lead to delays in walking and talking.
The Polings were exploring two theories to explain what happened to Hannah. One is that she was born with the mitochondria disorder and the vaccines caused a stress to her body that worsened the condition. The other is that the vaccine ingredient thimerosal caused the mitochondrial dysfunction, Jon Poling said.
CDC officials decline to talk about the Poling case, but they say it should not be used to draw conclusions about risks for other children.
Scientists believe that in cases in which a mitochondrial disorder causes a child's brain function to deteriorate, the disorder exists and then is worsened by a fever, infection or other stress on the body.
Scientists don't know if a vaccination — independent of fever or infection — can cause such a stress, said Dr. Edwin Trevathan, a pediatric neurologist who heads the
CDC's birth defects center.
Others echoed his assessment.
"There are no scientific studies documenting that childhood vaccinations cause or worsen mitochondrial diseases, but there is very little scientific research in this area," said Chuck Mohan, executive director the United Mitochondrial Disease Foundation, a
Pittsburgh-based group that raises money for research.
Mohan said there are more than 100 types of mitochondrial disease, and genetic tests can find only a couple dozen.
"Most children with autism do not seem to have a mitochondrial problem, so this association ... is probably relatively rare," said Trevathan.
Some research suggests the disorder occurs in one in 4,000 births, but some experts believe the rate is closer to one in 2,000, similar to childhood leukemia. And it is often just as fatal, said Mohan, who lost a daughter to the disease in 1995.
Other federal vaccine advisers seek to portray Hannah Poling as an isolated if not unique case.
She is "not a typical autistic child," said Dr. Paul Offit, chief of infectious diseases at
Children's Hospital of Philadelphia and a longtime government vaccine adviser. "It's not a precedent-setting case."
___
On the Net:
CDC Autism Information Center: http://www.cdc.gov/ncbddd/autism/
United Mitochondrial Disease Foundation:
http://www.umdf.org/site/c.dnJEKLNqFoG/b.3041929/
FDA is favorable on antianesthesia drug
Fri, 07 Mar 2008 17:26:44 GMT
WASHINGTON -
Federal health regulators said Friday a
Schering-Plough Corp. drug appears effective at helping patients recover from anesthesia, though some safety questions remain.
A
Food and Drug Administration panel of experts will meet next Tuesday to review Schering's Bridion, an injectable drug designed to reverse the effects of anesthesia in patients after surgery.
An analysis of the drug was posted to the
FDA Web site Friday, along with questions the agency will ask the panel. The agency is not required to follow the recommendation of its panel, though it usually does.
Similar drugs are on the market, but Schering said Bridion is unique because it reverses the effects of mild and serious anesthesia.
FDA reviewers said Bridion appears safe in healthy adults, but that additional studies may be needed to answer questions about allergic reactions and the drug's effects on children's' teeth.
The agency said it is concerned about reports of some adults having hypersensitivity reactions while taking the drug. Schering is studying the reactions, and
FDA said the results "could have a significant effect on the overall finding of safety" for the drug.
FDA also said Schering has not addressed Bridion's effects on teeth in young children. Studies of the drug in young rats showed it interfered with growth of tooth enamel.
Studies of the drug in human adults also showed minor changes in bone strength, though they were not considered significant.
Only one study of Bridion in children has been completed, the FDA said.
The agency will ask its advisers Tuesday whether the company should be required to conduct additional studies in children.
Shares of
Schering Plough Corp. fell 38 cents, or 1.9 percent, Friday to $19.65 in midday trading.
Bacteria Mix in Guts of Babies Predicts Obesity
Sat, 08 Mar 2008 04:47:32 GMT
By Kathleen Doheny
HealthDay Reporter
FRIDAY, March 7 -- The mix of bacteria in a baby's gut
may predict whether that infant will become overweight or obese later in
life, a new study suggests.
Babies with high numbers of bifidobacteria and low numbers of
Staphylococcus aureus may be protected from excess weight gain,
according to a team of researchers from the University of Turku in
Finland.
Their study was published in the March issue of
The American Journal
of Clinical Nutrition.
The researchers suggested their findings may help explain why
breast-fed babies are at lower risk for later obesity, since
bifidobacteria are prevalent in the guts of breast-fed babies.
Other studies repeatedly have found that being breast-fed is associated
with a reduced risk of excess weight or obesity in childhood, with the
risk lowered from 13 percent to 22 percent.
In the new study, researchers evaluated children who had been part of a
long-term study to evaluate the effect of probiotics on allergic disease.
Probiotics are potentially beneficial bacteria found in foods such as
yogurt and in dietary supplements.
The children had been evaluated at birth, five more times before age 2,
and then again at ages 4 and 7. The researchers in the original study had
also tested for intestinal microbes in fecal samples collected at 6 months
and 12 months.
For this latest study, the Finnish researchers selected 49 participants
from the larger study -- 25 of them were overweight or obese at age 7
years, and 24 were normal weight at the same age.
When they looked at the fecal samples, the average bacterial counts of
bifidobacteria when taken at 6 months and 12 months were twice as high in
those who were a healthy weight as in those who got heavy.
Those who stayed at a healthy weight also had lower fecal
S.
aureus levels at 6 months and 12 months than did those who got
heavy.
The
S. aureus may trigger low-grade inflammation, the authors
speculated, and that may also contribute to developing obesity.
In other research, gut bacteria in adults have been found to be altered
in obese adults who lost weight. Someday, the Finnish researchers
speculated, tinkering with gut flora may help prevent or treat
obesity.
The latest study doesn't pinpoint exactly why intestinal bacteria are
linked with the development of obesity, said Connie Diekman, director of
university nutrition at
Washington University in St. Louis and president
of the American Dietetic Association.
"The exact role that bacteria in the intestine play in development of
obesity is still the subject of much research," she said, "but the
benefits of breast-feeding are clear. Breast-feeding provides not only the
proper nutrition for your infant, but it provides benefits that may impact
long-term health and weight issues as well."
However, she added that, "while breast-feeding may play a role in the
weight of children, so many other factors influence weight that parents
shouldn't ignore good role modeling of
healthy food choices, proper
portions and regular physical activity. Healthy weight is a combination of
factors, and no single issue will be the cause of weight gain or the magic
answer to weight loss."
Another expert who has studied how obesity changes microbes in the gut
calls the new study unique, because it collected information over several
years and could look for differences in gut microflora. "The finding, that
the lean children harbored higher levels of bifidobacteria at younger
ages, is very intriguing," says Ruth Ley, a research assistant professor
at
Washington University School of Medicine in
St. Louis.
Still, she says, research on the role of gut bacteria in regulating
body weight is in the very early stages.
More information
To learn more about breast-feeding, visit the American Academy of Pediatrics.
Exmodel Waris Dirie found in Brussels
Fri, 07 Mar 2008 18:40:07 GMT
By PAUL AMES, Associated Press Writer
BRUSSELS, Belgium - Police on Friday found
Waris Dirie, three days after the
Somali-born model who launched a worldwide campaign against
female genital mutilation had vanished.
Dirie, 43, appeared to be in good health and was being questioned by police about the disappearance, said Estelle Arpigny, a spokeswoman for the prosecutor's office.
She declined to give further details, saying it was unclear what had happened since Dirie vanished early Wednesday. Belgian media reports said police found her Friday afternoon walking the
Brussels' Grand Place square.
Hours earlier, police had announced they were launching a nationwide search for the former model, who had last been seen getting into a cab after a mix-up over a hotel.
Dirie gained international fame as a model posing in
Chanel ads and acting in the 1987
James Bond movie "
The Living Daylights" before launching her campaign against female genital mutilation in 1996.
She shocked the world with a best-selling book "Desert Flower" that described how her genitals were sliced off with a dirty razor blade without anesthesia, and then stitched together.
Now a U.N. goodwill ambassador, she was due to speak on genital mutilation in Brussels at two conferences on women's rights organized by the
European Union, including one on Thursday attended by
Secretary of State Condoleezza Rice.
News of Dirie's disappearance came a week after French police said they had found the body of another former model of African origin who had campaigned against female genital mutilation. Guinean-born Katoucha Niane was discovered floating in the River Seine in Paris.
The French police said an autopsy showed no signs of foul play, raising the possibility that she may have fallen accidentally into the river. However, Katoucha's family members say they suspect homicide.
Dirie's manager, Walter Lutschinger, said she had been involved in an altercation in a hotel reception area after a taxi driver took her to the wrong branch of the
Sofitel hotel chain. The police were called and drove Dirie around Brussels looking for the correct hotel because she had apparently forgotten where she was staying.
At one hotel, while staff and police were checking for her name on a computer, Meilleur said Dirie stepped out saying she planned to buy cigarettes from an all-night kiosk, but instead climbed into a taxi and drove away.
An Austrian citizen, Dirie was attacked in her
Vienna apartment in 2004 by a Portuguese handyman who had stalked her. The man was given a five-month suspended sentence by an Austrian court.
___
Associated Press writers Constant Brand and Aoife White in Brussels and George Jahn in
Vienna contributed to this report.
___
On the Net:
Waris Dirie Foundation: http://www.waris-dirie-foundation.com
Vaccine Could One Day Control High Blood Pressure
Sat, 08 Mar 2008 04:47:43 GMT
By Steven Reinberg
HealthDay Reporter
THURSDAY, March 6 -- A vaccine that blocks so-called
angiotensin II receptors, thus relaxing blood vessels to lower blood
pressure, may one day replace current blood pressure medications, a new
study suggests.
The advantage of the vaccine is that it would only need to be given two
or three times a year and should help patients adhere to their medication
regimen, researchers say.
"We found the vaccine was well-tolerated, and it did lower blood
pressure in hypertensive people," said vaccine inventor Martin Bachmann,
of Cytos Biotechnology in
Schlieren, Switzerland.
Currently, there are two problems with high blood pressure drugs,
Bachmann said. "On the one hand, people just don't take them, and, on
other hand, the drugs don't work very well early in the morning," he said.
In the United States, only about one-third of people with high blood
pressure have their blood pressure under
control, according to background information for the study. Many people
don't take their blood pressure medications because of side effects,
concerns about the long-term effects of the drugs, and their lack of
perceptible symptoms, Bachmann noted.
"Our vaccine would only have to be taken maybe twice or three times a
year, not every day. In addition, it works best early in the morning,"
Bachmann said.
In the new study, Bachmann's team presented the results of an early
trial of 72 patients with mild to moderate high blood pressure who were
randomly assigned to receive the vaccine at two different doses or a
placebo.
The patients' blood pressure was measured before the trial and 14 weeks
after the trial began. The outcome the researchers were looking for was
whether the vaccine was safe and well-tolerated.
Bachmann's team found that patients who received the higher dose of
vaccine had a drop in their systolic blood pressure of 9 mm Hg and a 4 mm
Hg drop in their
diastolic blood pressure. The
blood pressure drop was
particularly significant in the early morning, where patients showed a 25
mm Hg drop in systolic blood pressure and a 13 mm Hg drop in
diastolic
blood pressure, compared with patients receiving a placebo.
Overall, the vaccine was well tolerated, with only 10 patients
reporting flu-like symptoms after the injection. Such reactions are common
with several vaccines, the researchers noted. In addition, some patients
experienced mild irritation at the injection site.
The study results are published in the March 8 issue of
The
Lancet.
More extensive testing is needed before the vaccine could be made
available to the public, Bachmann said. "We are moving on to eventually
large trials," he said.
One expert thinks this finding could be a breakthrough in helping
patients control their blood pressure.
"Poorly controlled blood pressure remains a
worldwide health-care
problem and contributes greatly to heart attacks, strokes, and
cardiovascular deaths," said Dr. Gregg C. Fonarow, a professor of
cardiology at the
University of California, Los Angeles.
Although there are lifestyle modifications and a number of effective
and reasonably well-tolerated medications that can help control blood
pressure, many patients don't adhere to their regimens in a way that works
effectively, Fonarow said. "A vaccinate for controlling blood pressure, if
proven to be safe and effective, could represent an important therapeutic
advance," he said.
This study is the first to show promising data with a vaccine against
angiotensin II, a potent constrictor of blood vessels, in patients with
mild to moderate hypertension, Fonarow said.
"While further studies for safety and efficacy, including ones that are
larger and follow patients longer, are clearly necessary, this is an
exciting development in the search for new and more effective means to
help patients achieve and maintain control of high blood pressure," he
said.
More information
To learn more about high blood pressure, visit the American Heart Association.
Government Assistance Linked to Better Child Development
Sat, 08 Mar 2008 04:47:34 GMT
FRIDAY, March 7 -- Extra government financial support
of poor families boosts children's physical and mental development, a U.S.
study concludes.
Researchers at the
University of California, Berkeley found that
children in low-income families in
Mexico who received an extra amount of
cash from a government-run conditional cash transfer program were taller,
less likely to be overweight, and scored higher on motor, cognitive and
language tests than children in families that received less money.
The findings were published in the March 8 issue of
The
Lancet.
Cash benefits in traditional welfare programs are based on a family's
income or residence in a specific geographical area. Conditional cash
transfer programs give money to low-income families if they meet specific
requirements, such as making sure their children attend school or get
vaccinated. Food and nutritional supplements are also included in some of
these programs, according to background information in the study.
"Previous research has shown positive outcomes for child development
from conditional cash transfer programs, but the general assumption,
particularly from the
public health perspective, was that the improvements
were the result of the health and education components rather than the
cash. This new study is the first to tease out the impact of the money
from the other elements of the program." lead author Lia Fernald,
assistant professor in
public health nutrition at
UC Berkeley's School of
Public Health, said in a prepared statement.
Fernald and her colleagues didn't analyze exactly how the extra cash
boosted child development but believe the additional money helped families
buy more nutritious food or medicine, or perhaps purchase items for the
home -- such as a refrigerator or a covering for a dirt floor -- that
improve their lives.
"Even the purchase of additional books or toys for the children --
something we often take for granted in this country -- could help
stimulate cognitive development," Fernald said.
"Also, the additional cash could have the psychological benefit of
taking some of the pressure off the mothers. These are families who are at
the bottom 20th percentile in
Mexico for household income. When relieved
of the constant worry about not providing enough food for their children,
mothers may feel less depressed and may be better able to interact with
their children."
In 1997, the Mexican government became the first to offer a conditional
cash transfer program, which now includes more than 5 million families and
has been replicated in more than 20 developing nations.
Last year,
New York City launched the first conditional cash transfer
program in a developing country. It's already distributed more than
$740,000 to more than 1,400 families who've met specific criteria related
to education, health, and workforce participation and training.
More information
The
U.S. Centers for Disease Control and Prevention has more about child
development.
Memory Loss in Hyperactive State With Alzheimer39s
Sat, 08 Mar 2008 04:47:33 GMT
FRIDAY, March 7 -- Memory loss, where the brain
deletes inconsequential information, is in a hyperactive state in people
with
Alzheimer's disease, a new study suggests.
Researchers at
California's Buck Institute for Age Research analyzed
human brain tissue and found that people with Alzheimer's disease
showed more signs of cleavage of a molecule called amyloid precursor
protein than people without the disease.
But when they analyzed the brains of younger people without
Alzheimer's, the researchers were surprised to find that they had about 10
times as much APP cleavage as Alzheimer's patients. However, younger
brains make memories faster than they lose them.
The Buck Institute team believes that the malfunction of a biochemical
switch associated with APP cleavage causes the brains of Alzheimer's
patients to get stuck in the process of deleting memories. They added that
this suggests the disease affects the plasticity or malleability of the
brain.
The study was published in the March 7 issue of the
Journal of
Alzheimer's Disease.
"Young brains operate like Ferraris -- shifting between forward and
reverse, making and breaking memories with a facility that surpasses that
of older brains, which are less plastic," research group leader Dr. Dale
Bredesen said in a prepared statement.
"We believe that in aging brains, AD occurs when the 'molecular
shifting switch' gets stuck in the reverse position, throwing the balance
of making and breaking memories seriously off kilter," Bredesen said.
Researchers at the Buck Institute are focusing on nerve signaling and
efforts to "disconnect" the molecular mechanism that causes this
hyperactivation of memory loss in people with Alzheimer's. They're also
investigating the mechanisms that support brain cell connections that play
a critical role in memory making.
About 5.1 million Americans have Alzheimer's, which costs the country
$148 billion a year.
More information
The National Institute on Aging has more about
Alzheimer's disease.
Researchers Design Promising Cancer Drug
Sat, 08 Mar 2008 04:47:31 GMT
FRIDAY, March 7 -- A drug that targets a protein
interaction involved in many types of cancer has been created by
University of Michigan researchers.
In cell cultures, the small-molecule inhibitor MI-219 was highly
effective at preventing the tumor-suppressor function of the protein p53
from being blocked in the presence of a protein called MDM2.
In animals with human cancer, MI-219 completely inhibited tumor growth
and appeared to cause no severe side effects.
"For more than 10 years, scientists have searched for ways to block p53
inhibition, but with little success. Our study clearly shows that this can
be done," study author Shaomeng Wang, a professor of medicine at the U-M
Medical School and co-director of the molecular therapeutics program at
the U-M Comprehensive Cancer Center, said in a prepared statement.
The research was published online this week in the Proceedings of
the National Academy of Sciences.
Clinical trials of the drug could begin by the end of 2008. If the drug
proves safe and effective in humans, it could potentially be used to treat
many kinds of cancer, according to the researchers.
In almost all types of human cancer, p53 is inactivated. About half the
time, this is because the protein MDM2 binds to p53 and inhibits the
tumor-suppressor function of p53. In other cases, p53 dysfunction is due
to a missing or mutated gene.
"Many traditional cancer drugs also activate p53, but they do so by
causing DNA damage. They kill not only tumor cells but also normal cells,
thus having severe side effects. MI-219 is unique in that it is designed
to activate p53 without causing DNA damage, specifically killing tumor
cells," Wang said.
The University of Michigan has filed a patent application for MI-219
and its related molecules. The technology has been licensed by Ascenta
Therapeutics Inc., which helped fund the study. Wang is a scientific
founder of Ascenta, serves as its chief scientific adviser, and is the
principal investigator on a research contract from Ascenta to U-M.
More information
The National Cancer Institute has more about cancer.