Entries in Drug (16)


Doctors Debate Effectiveness of Alzheimer's Milkshake

George Doyle/Thinkstock(NEW YORK) -- Some call it a novel approach to treating Alzheimer's disease. Others call it "snake oil."

Either way, Axona is different from other treatments. It's a milkshake -- not a drug, but a "medical food," and it's a controversial alternative for Alzheimer's patients and their caregivers who face a frustrating lack of options when it comes to treating the disease successfully. Like drugs, "medical foods" are regulated by the U.S. Food and Drug Administration (FDA), but the agency's approval standards for this category are far less rigorous than for drugs.

According to the Alzheimer's Association, there are just five FDA-approved drugs to treat the symptoms of Alzheimer's, compared with the dozens available for conditions like cancer or heart disease. And scientists say none of the Alzheimer's drugs provide patients any lasting protection from the gradual advance of the disease's symptoms.

"Current treatments are modestly useful, but certainly inadequate. There is an enormous need for more effective therapy for Alzheimer's disease," said Dr. Paul Aisen, a neuroscience professor at the University of California, San Diego. "Patients and families want to find anything that may help."

Without any "magic bullet" cures, alternative treatments like Axona can offer a glimmer of hope to patients who have tried everything without success. But doctors are divided over whether these treatments are worth exploring or if they merely give false hope to patients with few options.

According to Accera, the milkshake's manufacturer, Axona was created as a solution to the problem of brain cells in Alzheimer's patients not being able to use the fuel they need to function: glucose. Instead, Axona provides the brain with an alternative fuel source: fats called ketones. On its website, Accera says that one Axona milkshake each day will "improve cognitive function in some AD patients."

Some scientists point to a lack of data showing that the treatment has any real effect on the disease.

In 2009, Accera studied a small number of patients who drank one Axona milkshake per day, and found that they improved 1.9 points on a 70-point cognitive testing scale than patients who drank a placebo milkshake. However, the benefits didn't last as long as the company hoped -- only 45 days as opposed to the 90-day goal.

That short fall is enough to persuade scientists like Dr. Rudolph Tanzi, a neurology professor at Harvard Medical School, that the treatment is worthless.

"This is just expensive coconut oil," said Dr. Roger Brumback, professor of neurology at the Creighton University School of Medicine. "It's another example of false hopes and an entrepreneur's financial gain in a disease that is clearly devastating to patients and families."

But other physicians aren't so quick to dismiss Axona. Steven Ferris, director of the Aging and Dementia Research Center at New York University, serves on the scientific advisory board at Accera, Axona's manufacturer. He said Axona's method of using different fuel to power Alzheimer's brain cells is a legitimate idea that scientists have explored since the 1980s. Although Axona's benefits are not proven, he said he doesn't believe the idea behind it is entirely worthless.

"I wouldn't characterize it as snake oil, simply because it does have a scientific basis and there is some data that suggests a potential benefit," he said. "If this were out there available in the supermarkets, I'd really be concerned. But we do have gatekeepers, the physicians. It really comes down to individual judgments by prescribers as to whether this is appropriate for their patients or not."

Richard Isaacson, a neurologist at the University of Miami School of Medicine who is also a paid consultant for Accera, said he likes having new options to present to patients who have so few.

"I don't want to give patients false hope, but I want to give them options," Isaacson said. "I want to do anything and everything I can for them. As long as it's safe, I'm still going to try it."

Copyright 2011 ABC News Radio


Progeria Patients May Get Hope with New Research

Jupiterimages/Thinkstock(BOSTON) -- Doctors may be closer to finding a cure for patients with Progeria, an extremely rare and fatal genetic disorder which causes children to age eight to 10 times the normal rate, according to a new study published in Science Translational Medicine.

Progeria is caused by a protein called progerin which accumulates in cells much faster than the average rate.  But researchers found that a drug known as rapamycin slowed and even stopped the disease progression within the cells.

While the drug has only been tested in Petri dishes, scientists are excited about rapamycin's potential to treat the condition.

"Part of the problem with aging starts when debris is accumulating in the cells and it's not getting removed, and this particular drug is able to enhance the removal process," said Dr. Dimitri Krainc, lead author of the study.  "It would be too optimistic to say this could completely cure Progeria patients, but we're hoping that this drug could make these kids live longer with fewer complications."

Out of every four to eight million births worldwide, one child will be diagnosed with the condition.

Progeria patients appear healthy at birth, but soon after, parents and doctors begin to see signs of the condition.  Children with the disease are well below the average height and weight for their age.  Their head is disproportionately large for the face, they have a beaked nose, hair loss, a hardening of the skin and stiff joints.

Currently, the average lifespan of a Progeria patient is 13 years old.

"Lifespan can really range from 5 or 6 years to 22 years old," said Dr. Ted Brown, a pediatrician who has spent 30 years researching Progeria.  "In a typical course, by the time a patient gets to be 9 or 10, there is a hardening of the arteries, and they die of heart disease -- heart attack and stroke most typically."

The drug is already approved by the Food and Drug Administration as an antibiotic to fight rejection in organ transplant recipients.  Because it is already used for certain conditions, Krainc said this may allow for physicians to jumpstart clinical trials to test it as a treatment in Progeria patients.

Copyright 2011 ABC News Radio


Study: Two New Drugs Decrease Risk of Death in Melanoma Patients

Stockbyte/Thinkstock(CHICAGO) -- Researchers had some encouraging news for melanoma patients on Sunday, as it was revealed at an American Society of Clinical Oncology that two new drugs have been found to be effective in treating the disease.

A study found that after one year of testing, 84% of the patients on the Genentech drug, vemurafenib, were alive compared to 64% of the patients who got the standard chemotherapy. This represents a 63% reduction in the risk of death, for patients with melanoma, a deadly form of skin cancer.

The drug reportedly targets a genetic mutation in the cancer, resulting in fewer side effects than standard chemotherapy.

Researchers also disclosed that the drug yervoy, which harnesses the immune system to attack the cancer, when combined with chemotherapy also produced an improvement in survival.

The research findings were also published in the New England Journal of Medicine.

Copyright 2011 ABC News Radio


Study Suggests Using Exemestane to Prevent Breast Cancer

Comstock/Jupiterimages(ALEXANDRIA, Va.) -- Aromatase inhibitors are drugs that reduce levels of estrogen and are currently approved by the FDA for treatment of early breast cancer.

A new study has found that these drugs may also be effective in preventing breast cancer in high-risk women such as those over the age of 60 or those who have a history of breast cancer. Published in the New England Journal of Medicine, the findings of the study show that women taking exemestane, a type of aromatase inhibitor, had a 65% lower rate of breast cancer in the 3 year study period compared to women taking placebo. Specifically, 0.37% of women on the drug were diagnosed compared to 0.77% of those on the sugar pill.

The findings -- which were also presented at an American Society of Clinical Oncology meeting -- also state that exemestane should be considered a new option for prevention of breast cancer.

Copyright 2011 ABC News Radio


New HIV Treatment Approved by FDA

ABC News Radio(WASHINGTON) -- The U.S. Food and Drug Administration (FDA) has given approval to a new treatment for adults infected with HIV.

The FDA announced the approval of the drug Edurant (rilpivirine) on Friday, which officials say when used in combination with other antiretroviral drugs, can treat HIV-1 infection in patients who have never taken HIV therapy. The FDA says Endurant is to be used as part of a highly active antiretroviral therapy regimen aimed at suppressing HIV levels in the blood.

“FDA’s approval of Edurant provides an additional treatment option for patients who are starting HIV therapy,” said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

The approval comes following a trial phase involving over 1,300 adult patients with HIV.

Copyright 2011 ABC News Radio


Cartoid Stent Approved for Wider Use

Pixland(WASHINGTON) -- Officials have approved an expanded indication that will allow a new group of patients who face the risk of stroke, to be treated with the RX Acculink carotid stent.

The U.S. Food and Drug Administration (FDA) announced the approval on Friday, allowing patients with the risk of stroke due to clogged neck arteries to have the stent implemented. This is a follow-up to the 2004 move by the FDA to allow RX Acculink for use with patients who had clogged arteries and were faced with the risk of complications if they underwent surgical treatment that involved scraping out plaque from the neck artery.

The FDA’s latest approval regarding the RX Acculink, extends the indication for use of the stent to all patients with clogged carotid arteries who face the risk of stroke.

“Expanded access to RX Acculink means patients and their health care providers have another option for treating clogged neck arteries,” said Christy Foreman, M.B.E., director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.

According to a release from the FDA, with the RX Acculink, a catheter is inserted into the groin and then threaded up to the affected neck artery, following which a stent is placed into the artery to keep it open.

The FDA’s approval comes following a 10-year study that involved 2,502 patients at 119 clinical sites in the United States and Canada.

Copyright 2011 ABC News Radio


FDA Approves New Drug to Treat Pancreatic Cancer

Jupiterimages/Thinkstock(WASHINGTON) -- The U.S. Food and Drug Administration (FDA) has announced the approval of a drug that helps in the treatment of pancreatic cancer, providing some encouraging news for patients with the disease.

On Friday the FDA said that it has approved the drug Afinitor (everolimus) for treatment to patients with progressive neuroendocrine tumors located in the pancreas, that cannot be removed by surgery or that have spread to other parts of the body.

“Patients with this cancer have few effective treatment options,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “Afinitor has demonstrated the ability to slow the growth and spread of neuroendocrine tumors of the pancreas.”

In a news release, the FDA says the drug was deemed safe for use after a clinical trial involving 410 patients who either had progressive neuroendocrine tumors spread to other parts of the body or had a disease that could not be removed with surgery. During the trial some patients reportedly received Afinitor and others received placebo (sugar pill).

The FDA says after being treated with Afinitor, the median length of time patients lived without the cancer spreading or worsening was 11 months, as compared to a period of 4.6 months for patients that received placebo.

Afinitor has also been approved to treat patients with kidney cancer and patients with a type of brain cancer called subependymal giant cell astrocytoma.

Copyright 2011 ABC News Radio


Study Finds Cancer Drug Avastin May Be Cheap Alternative for Eye Disease

Banastock/Thinkstock(PHILADELPHIA) -- Results from a study comparing Avastin (a cancer treatment drug) and Ludentis (a drug used to treat a degenerative eye disease) confirmed that the two are nearly equal in effectiveness for improving visual acuity lost as a result of age-related macular degeneration (AMD), according to MedPage Today.

According to the study, published online Thursday in the New England Journal of Medicine, patients who received monthly doses of Avastin gained 8.0 letters of visual acuity compared to an 8.5 letter improvement that Ludentis produced.

Members of the opthalmology community had much looked forward to the release of the study's findings, given the substantial price difference of the two drugs, both made by Genentech.  One dose of Avastin, approved by the FDA only for cancer treatment costs, about $50, while one dose of Ludentis, approved only for AMD, will run patients about $2,000. 

Fearing the impact such a study could have on the sales of the more expensive Ludentis, Genetech has been reluctant, MedPage reports, to fund a head-to-head trial between the two.  As a result, the National Eye Institute provided funding for the study, called the Comparison of AMD Treatment Trials (CATT).

Copyright 2011 ABC News Radio 


Shortage of Leukemia Drug Forcing Hospitals to Turn Some Patients Away

Paul Tearle/Thinkstock(NEW YORK) -- A critical shortage of a leukemia drug has cancer centers across the country worried about how to treat many of their patients.

So far, oncologists in 30 states have reported a shortage of cytarabine, a drug that is key to treating certain types of leukemia. The situation, doctors say, is dire.

"If we can't get the drug, then the patients are going to die," said Dr. Hagop Kantarjian, chairman of the Department of Leukemia at the University of Texas M.D. Anderson Cancer Center in Houston.

The shortage began last fall, when the U.S. Food and Drug Administration (FDA) says "manufacturing delays" caused production to lag.

One of the drug's three U.S. manufacturers, Hospira, said in a statement that its delays were caused when the company was unable to obtain the active ingredient, cytarabine, from its supplier. Hospira and another manufacturer, APP, also had a problem with crystallization in drug vials. APP ended up recalling a supply in February.

Bedford Laboratories, the third manufacturer, said in a statement its delays are "due in part to the fact that Bedford continues to face increased market share of product demand due to a decrease in competitor's capacity."

Cytarabine is used as part of a drug regimen against acute myeloid leukemia (AML), a relatively rare cancer. It's sometimes used to treat acute lymphoblastic leukemia -- ALL for short.

For patients with AML who take cytarabine, the drug is the difference between a shot at life and certain death.

"Since its introduction, we can claim cures in 40 to 50 percent of patients," said Kantarjian. "Without the drug in the treatment regimen, the rate is zero."

Doctors say there are no suitable substitutes for cytarabine, leaving AML patients without a viable alternative. There are other drugs available for treatment of ALL.

Kantarjian was so concerned about the shortage that he emailed thousands of oncologists from all over the country, asking them how they've dealt with the diminished supply of cytarabine. M.D. Anderson, Kantarjian said, is fortunate because it's a large hospital and was able to purchase a long-term supply of the drug, so there is an adequate supply there right now.

When ABC News asked cancer centers around the country how the shortage has affected patient care, the responses flooded in.

A number of hospitals said they have to ration supply, meaning some patients won't get the doses they need. It also means they have to turn new patients away. Some hospitals said the shortage forces them to reserve whatever cytarabine they have for their current patients.

Copyright 2011 ABC News Radio


Memantine Not Effective in Slowing Progression of Alzheimer's

Jupiterimages/Thinkstock(LOS ANGELES) -- Despite millions of dollars spent on Alzheimer's research, the drugs that are used for "treating" the condition are not very effective, according to a new study published online in the Archives of Neurology

Yet with all the ads for Alzheimer's drugs, and little coverage of their limitations, it will likely surprise people to hear that one of the frequently prescribed drugs was found to have little, if any, effect.

Researchers from the University of Southern California reanalyzed data from already published studies and found that Memantine was no different than a sugar pill in its effects on learning, functional activities and behavior in patients with mild Alzheimer's.

While Memantine has been approved by the FDA for patients with moderate to severe Alzheimer's, health care professionals often prescribe the drug off-label for patients with mild Alzheimer's, according to HealthDay News.

Researchers say that the drug can be effective in helping patients with severe Alzheimer's to think more clearly and perform daily activities with more ease. However, Memantine is not a cure for Alzheimer's, nor can it cease progression of the disease.

Copyright 2011 ABC News Radio 

ABC News Radio