Drugs

Virus-Like Particle Vaccine Protects Monkeys from Chikungunya Virus

An experimental vaccine developed using non-infectious virus-like particles (VLP) has protected macaques and mice against chikungunya virus, a mosquito-borne pathogen that has infected millions of people in Africa and Asia and causes debilitating pain, researchers at the National Institutes of Health have found.

Scientists at the National Institute of Allergy and Infectious Diseases (NIAID) developed the vaccine because there is no vaccine or treatment for chikungunya virus infection. Details about the vaccine were published today in the online version of Nature Medicine.

“Increases in global travel and trade, and possibly climate change, may be contributing to the spread of disease-carrying mosquitoes into new areas,” says NIAID Director Anthony S. Fauci, M.D. “Finding safe and effective human vaccines for chikungunya virus and other insect-borne pathogens is an important global health priority.”

To develop the vaccine, scientists in NIAID’s Vaccine Research Center (VRC) identified the proteins that give rise to chikungunya VLPs. The VLPs mimic actual virus particles but cannot cause infection, so they can be used safely as a vaccine to elicit immune responses. The researchers immunized rhesus macaques with the VLPs, waited 15 weeks before exposing the animals to chikungunya virus, and observed that the vaccine provided complete protection from infection.

When the group found that antibodies were responsible for immune protection, they transferred antibody-containing serum from the vaccinated macaques to mice with deficient immune systems. The mice then were exposed to a lethal dose of chikungunya virus, but the immune serum protected them from infection.

“This virus-like particle vaccine provides a promising way to protect against an emerging infectious disease threat,” says VRC Director Gary Nabel, M.D., Ph.D. “This same approach could possibly extend to viruses related to chikungunya that cause fatal diseases such as encephalitis.” Dr. Nabel says his group plans to seek approval for clinical trials to further evaluate the safety and efficacy of the vaccine in humans.

There are two VLP vaccines for other diseases approved by the Food and Drug Administration: one for hepatitis B and one for human papillomavirus. This study marks the first time that scientists have used VLPs in a vaccine to protect against chikungunya virus, which is in the genus Alphavirus. The group plans to determine whether VLPs will work against other alphaviruses, such as Western and Eastern equine encephalitis virus found in the United States and o’nyong-nyong virus found in Africa.

Investigators from Purdue University, the University of Texas Medical Branch at Galveston, and Bioqual, Inc., in Rockville, Md., collaborated with NIAID scientists on this study.

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Drugs

Burning Heart Tissue

Beats Atrial Fibrillation

If drugs don't work, catheter ablation does the job, study finds

By Ed Edelson
HealthDay Reporter

TUESDAY, Jan. 26 (HealthDay News) -- When drug therapy can't control the dangerous heart rhythm disorder called atrial fibrillation, burning out the cardiac tissue responsible for the abnormality will do the job in most cases, a new study has found.

Called catheter ablation, the burning technique ended episodes of abnormal heartbeat and improved the quality of life over a nine-month period for two-thirds of the people in the study who had the procedure, compared with 16 percent of those who were started on a new drug regimen.

The finding was reported in the Jan. 27 issue of the Journal of the American Medical Association.

In atrial fibrillation, the upper chambers of the heart have episodes in which they quiver rather than beat to circulate blood. The episodes are often uncomfortable, causing chest tightness, pain and other symptoms. In addition, clots can form in the stagnant blood, traveling to block arteries and causing heart attacks or strokes. An estimated 2 million Americans have the condition, which becomes more common with aging.

A variety of drugs are used to treat atrial fibrillation, but initial drug therapy will not satisfy about half the people with the condition, said study author Dr. David J. Wilber, who is director of the Cardiovascular Institute at Loyola University Medical Center in Illinois.

"What has become clear is that once you fail one drug, your chances of responding to another drug are limited," he said. At that point, Wilber said, he might suggest catheter ablation, in which an electrical impulse is transmitted to eliminate the source of the irregular heartbeat.

The study, done at 19 hospitals in the United States and abroad, included 167 people whose atrial fibrillation was not controlled by one or more drugs. Of that group, 106 people had catheter ablation treatment and 61 were given a different drug. The trial was cut short because of the obvious advantages of catheter ablation, the researchers reported.

But that does not mean that catheter ablation is the first choice for treatment of atrial fibrillation, Wilber noted. He said he suggests it only when drug therapy clearly is not working, with the choice largely left up to the person with the condition.

"Some patients may say they want to try anything else first, some say they want the invasive procedure [catheter ablation]," he said. "This study offers the possibility of catheter ablation replacing drug therapy in these cases because the trial shows those patients do better."

Catheter ablation does have its risks, Wilber acknowledged. Previous studies have found a complication rate of 1 percent to 5 percent, he said. No such complications were seen in the new study.

"The amount of heart tissue that is destroyed has a relatively small effect on heart function," Wilber said. "That tissue isn't missed by the heart as much as you might expect."

And though many large medical centers are equipped for catheter ablation, expertise in the technique can differ, he said. "There is a very large range of experience," Wilber said. People considering the procedure should check published reports of clinical trials for evidence of a given medical center's expertise.

"I don't think there is a simple way right now" to do this, Wilber said, adding that "there is considerable interest in a national registry, as for heart surgery."

Dr. Frank Marchlinski, director of the electrophysiology program at the University of Pennsylvania and a member of the research team, said the study "demonstrates convincingly that, with catheter ablation, the outcome is dramatically better."

Like Wilber, Marchlinski said he, too, would suggest the procedure when drug therapy isn't working.

"I give patients that information, describe the opportunity of catheter ablation and the risk of catheter ablation," Marchlinski said. "I tell them that there is only a 20 percent chance of long-term success with other drugs."

But because atrial fibrillation generally is not immediately life-threatening, "it doesn't mean with absolute certainty it has to be done," he said. "This is an elective procedure. It is appropriate to consider it for those who do not want to take drugs."

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Drugs

Overdoses From Prescription

Painkillers on the Rise

Use of opioids such as oxycodone, hydrocodone soaring, researchers say.

By Jennifer Thomas
HealthDay Reporter

TUESDAY, Jan. 19 (HealthDay News) -- Overdoses from prescription painkillers are increasing in the United States, a new study shows.

Researchers examined pharmacy files on 9,940 adults who took opioids such as oxycodone and hydrocodone for at least three months between 1997 and 2005. The patients, who were insured and members of the Group Health Cooperative in Washington, were prescribed the drugs for chronic pain due to non-cancer causes, including conditions of the back or neck, headaches, jaw pain, pain in the extremities, arthritis and menstrual pain or injuries.

Fifty-one patients overdosed on the drugs; six of the overdoses were fatal, the researchers found.

The risk of overdosing increased with the amount of drug prescribed, according to the study. Those given higher doses had nearly nine times the chance of overdosing as those given lower doses of opioids.

"The rate of overdose was strongly related to dose," said senior study author Michael Von Korff, a senior investigator at the Group Health Research Institute in Seattle. "For patients currently receiving higher-dose regimens, their rate of overdose was almost 2 percent per year, which is a lot."

Patients who were depressed, had a history of substance abuse or who were also taking sedative-hypnotics, such as sleeping pills, had a higher risk of overdosing.

The study is published in the Jan. 19 issue of the Annals of Internal Medicine.

One reason for the greater reliance on opioids is a recognition among physicians that chronic pain is a serious problem, hindering people from working, sleeping and enjoying their lives, Von Korff said.

Use of the drugs also increased after two prominent pain management societies said that pain had been under-medicated because of fears of addiction, said A. Thomas McLellan, deputy director of the White House Office of National Drug Control Policy, who co-authored an editorial accompanying the study.

"That may have been a correct conclusion but, oh baby, did that lead to a dramatic change in practice," McLellan said. "Opioids are now among the most available and the most prescribed class of drugs."

Today, about 3 percent of the U.S. population are long-term users of opioids such as oxycodone, hydrocodone, codeine, morphine and methadone, according to background information in the article. "Our research suggests the rate of use doubled between 1997 and 2005, and probably doubled in the eight or nine years prior to that," Von Korff said.

The greater availability of the drugs has led to an increase in abuse, McLellan noted. Opioids are frequently "diverted," meaning one person gets the prescription and then gives it or sells it to another. A recent study found that less than half of those who died due to accidental overdose had actually received the drugs from a physician.

Yet less was known about the risk of overdosing in patients receiving the drugs from their physicians for pain, Von Korff said.

Among patients in the study, the cause of the overdoses varied. Medical records showed eight people accidentally took too much. Six were suicide attempts, while three had also obtained additional opioids from non-medical sources.

But in most cases, the reason for the overdose was unclear, including whether patients were taking the medications as intended when they overdosed, or if they had accidentally -- or intentionally -- taken more than was prescribed.

Symptoms of people who overdosed were delirium, loss of consciousness, confusion, respiratory problems and falling.

Because of the risks, physicians should closely monitor patients who are on long-term opioid therapy, prescribe as low a dose as possible to control pain and frequently re-evaluate whether the benefit of the drug is worth the risk.

"We need to consider what can be done to maintain the medical benefits of prescribed opiates -- you don't want to reduce appropriate availability -- while recognizing there are public health side effects," McLellan said.

Patient education and patient contracts, in which patients pledge to not share the drugs with others and to only use as necessary, have been shown to help, McLellan said.

"Patients must assume more responsibility for the storage and proper use of these medications, and doctors and dentists must recognize there are public health as well as individual patient implications," McLellan added.

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Drugs

Tylenol Recall Expands

to Include Other OTC Meds

FDA criticizes manufacturer for slow reaction to consumer complaints.

By Steven Reinberg
HealthDay Reporter

FRIDAY, Jan. 15 (HealthDay News) -- As a Johnson & Johnson subsidiary expanded its recall of some of its over-the-counter drugs on Friday, federal health officials said a warning letter has been sent to the company for failing to act quickly to take the products off the shelves after customers were sickened by a moldy smell on the medications.

"This morning, McNeil Consumer Healthcare voluntarily expanded its recall of over-the-counter drugs to include approximately 500 lots of products," Deborah M. Autor, director of the Office of Compliance in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, said during a morning teleconference Friday.

The company's recall started last September and was limited to certain lots of Tylenol, although that recall was expanded in December. The recall now includes certain lots of Motrin, Benadryl, Rolaids and St. Joseph aspirin.

To date, there have been some 70 reports from consumers about the problem, and in some cases using these products has resulted in nausea, stomach pain, vomiting and diarrhea, Autor said.

The company believes the contamination was caused by a chemical used to treat the wooden pallets on which packaging material is transported and stored. The chemical, 2,4,6-tribromoanisole (TBA), also occurs naturally and has been blamed for giving wine a moldy taste.

"The health effects of this chemical have not been well-studied, but no serious events have been documented in the medical literature," Autor said.

According to McNeil, it is possible that the TBA leeched into the packaging material and then into the products themselves.

While Autor commended the company for broadening its recall to include products that consumers have not complained about, she chastised them for acting too slowly to report and investigate the problem.

The first complaints of a musty odor in Tylenol Arthritis Relief Easy Cap products reached company officials in May 2008, but it wasn't until September of that year that the company began to investigate the problem.

Then, McNeil did not notify the FDA of the problem until September 2009, Autor said. "When something smells bad -- literally or figuratively -- companies must aggressively investigate and take all necessary action to solve the problem," she stressed.

Since then, the agency has repeatedly urged McNeil to identify the source of the problem and to recall affected products. Under current law, the FDA cannot order a recall, Autor noted.

The first recall of products was in early September 2009; the recall was expanded in December 2009 to include all Tylenol Arthritis Relief caplets. In addition, the FDA inspected McNeil's primary manufacturing plant in Las Piedras, Puerto Rico.

Based on this data, the agency has sent McNeil a warning letter citing multiple violations of "good manufacturing practice requirements," Autor said. "[The] FDA also warned McNeil for failing to report quality problems to the agency."

"McNeil and all drug manufacturers have a corporate responsibility to ensure their products are high-quality, safe and effective," Autor said. "When a problem arises with their products they must be proactive, quick and thorough in order to assure the quality, safety and effectiveness of their products and protect consumers."

For its part, McNeil said this in a statement released Friday: "In addition to the product recall, McNeil Consumer Healthcare is continuing their investigation into this issue and is taking further actions that include ceasing shipment of products produced using materials shipped on these wood pallets and requiring suppliers who ship materials to our plants to discontinue the use of these pallets. We will continue to closely monitor and evaluate the situation and consult with the FDA."

Recalled products include specific lots of:

• Regular Strength Tylenol
• Extra Strength Tylenol
• Children's Tylenol
• Tylenol 8-Hour
• Tylenol Arthritis
• Tylenol PM
• Tylenol Simply Sleep
• Children's Motrin
• Motrin IB
• Benadryl
• Rolaids
• St. Joseph aspirin

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Drugs

Celebrex Might Thwart

Inherited Skin Cancers

Drug led to fewer basal cell carcinoma lesions in study patients.

FRIDAY, Jan. 8 (HealthDay News) -- People with an inherited skin disorder could reduce their risk of developing skin cancer by taking the painkiller celecoxib (Celebrex), a preliminary study suggests.

The research has only reached the second of three phases, however, and the drug is not yet officially approved for this use.

The condition, known as Gorlin syndrome, causes people to develop hundreds or even thousands of cancerous lesions known as basal cell carcinomas.

According to one of the researchers, the goal is to find a way to prevent cancer in everyone. "The underlying idea is if we can find something in these high-risk patients that could be translatable to the 'normal' population, then we could ultimately use that form of chemoprevention to reduce the numbers of skin cancer in all people," Dr. Ervin H. Epstein Jr., senior scientist at the Children's Hospital of Oakland Research Institute in California, said in a news release from the American Association for Cancer Research.

The researchers found that patients with basal cell carcinoma who took 200 milligrams of oral celecoxib two times a day had significantly fewer lesions after two years compared with patients who were given a placebo.

But the painkiller has been linked to cardiovascular side effects, Epstein said, and more research is needed.

The findings are published in the January issue of Cancer Prevention Research.

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Drugs

Older Antidepressant

May Treat Heart Failure

The drug clorgyline shows promise in animal tests, but side effects concern researchers.

FRIDAY, Jan. 8 (HealthDay News) -- An older antidepressant that's no longer prescribed may find new life as an effective heart failure treatment, research suggests.

The drug, known as clorgyline, hasn't been tested in humans as a heart-failure medication, but research in animals has found it can reduce and even reverse the symptoms of heart failure, including enlargement of the heart and a weakened ability to pump blood through the body.

Researchers reporting their findings in the Jan. 8 issue of Circulation Research say the drug blocks a key enzyme called monoamine oxidase-A. Clorgyline stops the enzyme from breaking down a neurohormone -- norepinephrine -- that controls the pace of the heart's pumping.

"Our study helps describe heart failure as a vicious chemical circle of stimulant norepinephrine overload and breakdown, and it offers a disease blueprint with monoamine oxidase-A as the target for drugs similar to clorgyline to rein in the disease," says senior study investigator and cardiologist Dr. Nazareno Paolocci in a statement. He is an assistant professor at the Johns Hopkins University School of Medicine and at the University of Perugia in Italy.

However, clorgyline also has a variety of side effects, Paolocci said, and people who take it have to avoid a long list of foods. Newer drugs in the same class as clorgyline will have to be tested first, he said.

An estimated 5.7 million American men and women suffer from chronic heart failure. The disorder killed an estimated 290,000 people in 2005.

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Drugs

Experimental Drug

May Help in Brain,

Prostate Cancers

Study finds that imetelstat targets mechanism that allows cancer cells to divide.

MONDAY, Jan. 4 (HealthDay News) -- An experimental drug called imetelstat shows promise in treating glioblastoma brain cancer and prostate cancer, according to the results of preclinical studies in which the drug was tested on human prostate cancer cells and in rodents with glioblastoma.

Researchers from the University of Texas Southwestern Medical Center found that the drug had an effect on most tumor cells, as well as cancer stem cells believed to cause most of a cancer's growth. Tests in mice with glioblastoma also showed that the drug was able to cross from the bloodstream into the brain. Most drugs cannot cross the blood-brain barrier.

The glioblastoma study is published in the January issue of Clinical Cancer Research, and the prostate cancer study was published online in the International Journal of Cancer.

Imetelstat (also called GRN163L) is being tested in clinical trials as a treatment for breast cancer, lung cancer and lymphocytic leukemia. The drug targets a mechanism that allows cancer cells to continue dividing.

"Because it attacks a mechanism that's active in most cancers, it might prove to be widely useful, especially when combined with other therapies," Dr. Jerry Shay, a professor of cell biology at the university and senior co-author of both studies, said in a university news release.

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Drugs

New Blood Thinner Could

Replace Warfarin to Fight

Venous Clots

Dabigatran equals older anti-clotting drug, with fewer hassles, study finds

By Amanda Gardner
HealthDay Reporter

MONDAY, Dec. 7 (HealthDay News) A new blood thinner called dabigatran etexilate may be just as effective in preventing dangerous venous clots as an old standby, warfarin, but much easier for doctors and patients to manage, a new study finds.

Dabigatran is marketed as Pradax in Canada and Pradaxa in Europe; it is not yet approved for use in the United States.

The new study, published early online Dec. 6 by the New England Journal of Medicine, follows on the heels of two other promising reports presented at the American Heart Association meeting in Orlando, Fla., last month. Those studies found that dabigatran appeared safe and effective in preventing blood clots when patients were treated for acute coronary syndrome, a cluster of symptoms that might indicate a heart attack; it was also found superior to warfarin in preventing strokes in patients with the irregular heartbeat known as atrial fibrillation.

In the new trial, warfarin and dabigatran seemed to perform equally well in helping patients with potentially dangerous clots in their veins avoid a subsequent clot or death over the next six months.

But it is in its ease of use that the newer drug appears to outshine warfarin, the authors of this latest study say.

Doctors have for years been looking for a safe alternative to warfarin, which is notoriously difficult to manage.

"For patients and health-care providers, dabigatran is a far more convenient drug than warfarin because it has no known interactions with foods and minimal interactions with other drugs and therefore does not require routine blood-coagulation testing," wrote the international team of researchers led by Dr. Sam Schulman of McMaster University and the Henderson Research Center in Hamilton, Ontario, Canada.

In the prospective trial, which was funded by dabigatran's maker, Boehringer Ingelheim, nearly 1,300 patients who had experienced a venous thromboembolism (VTE) received 150 milligrams of dabigatran in pill form twice a day. Another group of almost 1,300 patients was given warfarin, adjusted in dose to suit their particular needs.

Six months after the therapies began, 30 patients on dabigatran experienced another VTE compared to 27 patients on warfarin, for a 0.4 percent difference in risk, the authors report. Side effects such as major or minor bleeding were similar between the two groups, with slightly more bleeding events occurring in those on warfarin.

Based on the results, the authors conclude that, "a fixed dose of dabigatran is as effective as warfarin, has a safety profile that is similar to that of warfarin, and does not require laboratory monitoring."

Those optimistic findings echo those from the American Heart Association meeting in November. That study involved more than 1,800 patients in 24 countries with acute coronary syndrome -- a cluster of symptoms that might indicate a heart attack. Patients received one of four doses of dabigatran or a placebo on top of aspirin and the blood thinner Plavix.

The study found dabigatran safe in preventing blood clots in these heart patients. Researchers also saw reductions in mortality, nonfatal heart attack and stroke, although the trial was not specifically designed to look at efficacy.

"Dabigatran seems to be safe on top of dual antiplatelet therapy [meaning aspirin and Plavix]," study author Dr. Jonas Oldgren, chief physician in the department of cardiology at Uppsala University Hospital in Uppsala, Sweden, said at the time. "It has already been shown to have superior efficacy compared with warfarin."

And another trial, also presented at the AHA meeting, demonstrated that dabigatran outperformed warfarin in preventing strokes in patients with atrial fibrillation.

"Dabigatran appears to be superior to warfarin in terms of safety and more effective as well. This is the first alternative to warfarin that could signal a changing of the guard," Dr. Bernard Gersh, a professor of medicine at the Mayo Clinic College of Medicine in Rochester, Minn, said during the heart association conference. "I think there are still questions that need to be answered, but it's fair to say that warfarin has been around for many, many years and everybody hates warfarin. Patients hate warfarin. Doctors hate warfarin. It's not the most convenient drug, but it's effective and it is cheap."

"It's premature to say that a drug like dabigatran will take the place of warfarin," Gersh added. "There will be a lot of discussion about cost and convenience. It's a twice-daily dose and there are some questions about a possible higher rate of heart attack. I don't think this is truly resolved yet, but I think we can say that for the first time we have seen a drug that certainly has the potential to be an alternative to warfarin, and maybe even superior."

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Drugs

Hormonal Drugs Cool Hot

Flashes From Prostate

Cancer Therapy

Medroxyprogesterone wins out in comparison study.

SUNDAY, Dec. 6 (HealthDay News) -- Hot flashes caused by androgen suppression therapy for prostate cancer are best controlled by the hormonal treatments cyproterone acetate and medroxyprogesterone acetate, according to a new study.

Androgen suppression is considered the gold standard treatment for advanced prostate cancer, but about 80 percent of patients undergoing the treatment experience hot flashes. A number of hormonal and non-hormonal drugs are used to treat the hot flashes, but no direct comparisons of the drugs have been made in clinical trials.

The new study included 311 prostate cancer patients in France undergoing androgen suppression therapy. To treat their hot flashes, they received either the non-hormonal drug venlafaxine (102 men), or one of two hormonal drugs -- cyproterone acetate (101 men) or medroxyprogesterone acetate (108 men). The patients were assessed at weeks four, eight and 12 and asked to complete a questionnaire about the frequency and severity of their hot flashes for the week before each assessment.

The researchers found that all three drugs reduced the occurrence of hot flashes, but the hormonal drugs were much more effective at reducing them over all time periods.

After receiving treatment for four weeks, 219 patients (nearly 71 percent) reported an improvement of at least 50 percent in their hot flash scores, and 70 patients (nearly 23 percent) said they no longer had hot flashes. By the fourth week, hot flash scores were reduced by 47.2 percent for the venlafaxine group, 83.7 percent for the medroxyprogesterone acetate group and 94.5 percent for the cyproterone acetate group.

Among men receiving gonadotrophin-releasing hormone analogue therapy for prostate cancer, cyproterone acetate and medroxyprogesterone acetate are more effective at 12 weeks for treating hot flashes, the researchers concluded. However, "as cyproterone is a recognized treatment in prostate cancer, and its use could interfere with hormone therapy, medroxyprogesterone should be the standard treatment," they wrote.

The study will be published online Dec. 7 in The Lancet Oncology.

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Drugs

Cervarix Proves Effective Against HPV for Over 6 Years

Vaccine protected volunteers from virus linked to cervical cancer

URL of this page: http://www.nlm.nih.gov/medlineplus/news/fullstory_92556.html (*this news item will not be available after 03/03/2010)

HealthDay Robert Preidt Thursday, December 3, 2009

WEDNESDAY, Dec. 2 (HealthDay News) -- The human papillomavirus (HPV) vaccine Cervarix protects women from infection for longer than six years, new research has found.

The vaccine guards against the two types of HPV (HPV-16 and HPV-18) most commonly associated with cervical cancer.

The study looked at nearly 800 women, aged 15 to 25, with a normal cervical profile and no evidence of HPV infection at the start of the trial. There were 393 women who received the Cervarix vaccine and 383 who received an inactive placebo. Every six months for 6.4 years, the women were tested for HPV DNA.

The researchers found that vaccine efficacy against 12-month persistent infection with HPV-16/18 remained 100 percent during the study period. Vaccine efficacy against incident infection with HPV-16/18 was 95 percent. Antibody concentrations against HPV-16/18 in vaccinated women remained at least several-fold higher than would be found after natural HPV infection, the study authors noted.

Cervarix also protected women against incident infection with HPV-31 and HPV-45, which "are among the types most frequently associated with cervical cancer after HPV-16 and HPV-18, and are responsible for 10 percent of all cervical cancer cases," wrote Dr. Cosette Wheeler, of the Health Sciences Center at the University of New Mexico, and colleagues.

The study was released online Dec. 2 in advance of publication in an upcoming print issue of The Lancet.

"Although further assessment is necessary to confirm long-term vaccine effects, in view of the data from our study, we expect protection to continue for many more years," the researchers concluded.

Cervarix, from GlaxoSmithKline, received U.S. Food and Drug Administration approval in October.

SOURCE: The Lancet, news release, Dec. 2, 2009

HealthDay
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Drugs

High-Risk Women May

Often Avoid Using Tamoxifen

Armed with knowledge of risks, many hesitate to take breast cancer drug, study finds.

FRIDAY, Dec. 4 (HealthDay News) -- Worries about side effects are a major reason why only 6 percent of American women at high risk for breast cancer are willing to take the drug tamoxifen to prevent the disease, a new study finds.

In an effort to inform women about the risks and benefits of tamoxifen, researchers at the University of Michigan Comprehensive Cancer Center created a decision aid, which was tailored to the health history of each of the 632 women in the study.

"That means, when women read this decision aid, they learned about how the drug was likely to affect them given their age, race, breast cancer history and medical history," study author Angela Fagerlin, an associate professor of internal medicine at the University of Michigan Medical School and a research investigator at the VA Ann Arbor Healthcare System, said in a university news release.

The researchers found that the decision aid helped inform the women about the risks and benefits of tamoxifen, with 63 percent correctly answering at least five of the six questions about the drug and 41 percent getting all six questions right.

However, although the women apparently achieved a high level of understanding about the risks and benefits of tamoxifen therapy, only 29 percent said they were likely to look for more information about the drug, 29 percent said they'd talk to their doctor about it and only 6 percent said they were likely to take tamoxifen. When questioned about the drug again three months later, fewer than 1 percent of the women had started taking the drug and fewer than 6 percent had sought more information or talked to their doctor about tamoxifen.

Eighty percent of the women in the study said they were worried about the drug's side effects, which can include hot flashes, sexual problems and, in rare cases, blood clots, cataracts or endometrial cancer, the study authors noted.

"Experts have bemoaned the dearth of women taking these pills, worried that word has not gotten out about tamoxifen's ability to prevent breast cancer in high-risk women. Our study shows that even when the word does get out, most women are too concerned about the pills' side effects to want to take it," senior author Dr. Peter Ubel, a professor of internal medicine and director of the University of Michigan's Center for Behavioral and Decision Sciences in Medicine, said in the news release.

The study was released online in advance of publication in an upcoming print issue of the journal Breast Cancer Research and Treatment.

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Drugs

Makers of Powerful Painkillers Present Safety Plans

Move a response to pressure from federal regulators to crack down on abuse of opioid medications.

By Alan Mozes
HealthDay Reporter

FRIDAY, Dec. 4 (HealthDay News) -- The makers of 24 different prescription painkillers on Friday presented federal regulators with plans to curb the abuse of these opioid drugs.

The pharmaceutical companies have been under pressure from U.S. Food and Drug Administration officials to find a way to stop the hundreds of fatal overdoses that occur with these medications each year, the Associated Press reported.

Executives from Johnson & Johnson, King Pharmaceuticals and other drug makers proposed using patient medication guides, letters to doctors and additional physician training to end the misuse and inappropriate prescribing of painkillers, according to the wire service.

In February, FDA officials sent letters to 16 companies ordering them to design risk-management plans for their drugs. The drug makers presented their joint proposal to the agency after several months of discussion.

The painkillers in question include morphine, oxycodone and methadone.

This marks the first time the agency has required a risk-management plan for an entire class of drugs, the AP reported.

However, the problem is significant: a 2007 survey found 5.2 million people in the United States reported using prescription painkillers inappropriately.

Such drugs are typically approved for people requiring round-the-clock treatment for moderate to severe chronic pain, such as cancer patients.

But, significant harm can occur if patients are uninformed about how to properly take the drugs, doctors inappropriately prescribe the drugs, or if legitimate prescriptions get into the hands of people other than the intended patient, Dr. John Jenkins, director of the FDA's Office of New Drugs, part of the Center for Drug Evaluation and Research, said during a news conference back in February.

Jenkins said then that the agency was taking this step to implement "a relatively massive new program," because "the rates of misuse and abuse [of opiates] have risen over the past decade." He also said the FDA was better able to address the problem, because the Food and Drug Administration Amendments Act of 2007 gave the agency the authority to regulate opioids.

This is "our attempt to try and ensure that the benefits of the products outweigh their risks," Jenkins said in February.

In addition to patient misuse, the FDA has documented many cases of physicians prescribing the potent painkillers for people with migraines, an unapproved use. The FDA said patients also sometimes chew extended-release pills that are designed to be swallowed, causing an accidental overdose of the drug.
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Drugs

An online pharmacy is a

convenient

way to purchase medicines

by tomcornishy4

in Health

(submitted 2009-12-03)

0

votes

vote

Purchasing medications on-line is one of the best ways to receive an appropriate medical service hassle-free. The on-line pharmacy is a dependable, convenient and money-saving way of purchasing medications and professional medical assistance by a few mouse clicks. It provides the privacy you desire and prices which enable you to spend less money on drugs and more on other necessities. It spares a lot of time. Sometimes people have to drive from pharmacy to pharmacy in search of a certain product. You simply order a drug on-line and have it delivered to your house. It is particularly suitable for elderly people and those who live in remote places. Some pharmacies deliver products free of charge. An online pharmacy promises a quick filling of prescription medications. If you have any doubts regarding prescription or no-prescription drugs, you are free to ask a pharmacist working for an on-line pharmacy either by sending an e-message or making a phone call. Surely, you will be asked to provide your medical history form for the pharmacist to ensure that the drug you are going to take is safe for you. It is essential to find a dependable online pharmacy among hundreds that will satisfy your requirements to the full. Make sure the pharmacy you do business with is licenced and sells medications sanctioned by the U.S. Food and Drug administration (FDA). Avoid fake medications. There have been some cases when on-line pharmacies have sold counterfeit products. They are normally ineffective or dangerous to your well-being. When you receive your on-line prescription, check the delivery thoroughly to insure that the package is genuine and has not been broken or tampered. A reliable pharmacy clearly post confidentiality and protection policies on its site. Make sure you read them thoroughly prior to providing any personal information, such as your plastic details and medical history. Be cautious when purchasing products from online pharmacies located outside the USA. Medications may not be genuine. It is very likely that drugs have not been produced, stored, packaged, and dispatched under the safety standards outlined by the FDA. Some foreign on-line pharmacies likewise deal drugs that have been banned in the USA..


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Drugs

Review Finds Marijuana

May Help MS Patients

However, benefits are not clear enough to recommend its use, experts say.

By Steven Reinberg
HealthDay Reporter

FRIDAY, Dec. 4 (HealthDay News) -- Cancer patients, glaucoma patients and others can benefit from medical marijuana, and now a new analysis shows that it can help multiple sclerosis (MS) patients find relief from the muscle spasms that are the hallmark of the debilitating autoimmune disease.

"The therapeutic potential of cannabinoids in MS appears to be comprehensive, and should be given considerable attention," said lead researcher Dr. Shaheen Lakhan, executive director of the Global Neuroscience Initiative Foundation.

"Spasticity, an involuntary increase in muscle tone or rapid muscle contractions, is one of the more common and distressing symptoms of MS," the researchers noted in their review. "Medicinal treatment may reduce spasticity, but may also be ineffective, difficult to obtain or associated with intolerable side effects," they added.

"We found evidence that cannabis plant extracts may provide therapeutic benefit for MS spasticity symptoms," Lakhan said.

Although some objective measures showed improvement, there were no significant changes in after-treatment assessments, Lakhan said. "However, subjective assessment of symptom relief did often show significant improvement post-treatment," he added.

For the study, Lakhan and his colleague Marie Rowland reviewed six studies where marijuana was used by MS patients. Five of the trials showed that marijuana reduced spasms and improved mobility, according to the report published Dec. 3 in the online journal BMC Neurology.

Specifically, the studies evaluated the cannabis extracts delta9-tetrahydrocannabinol (THC) and cannabidiol (CBD). These studies found that both THC and CBD extracts may provide therapeutic benefit for MS spasticity symptoms, Lakhan said.

Although there was a benefit from using marijuana there were also side effects, such as intoxication. This varied depending on the amount of marijuana needed to effectively limit spasms, but side effects were also seen in the placebo groups, Lakhan and Rowland noted.

The careful monitoring of symptom relief and side effects is critical in reaching an individual's optimal dose, Lakhan said. "Moreover, there is evidence that cannabinoids may provide neuroprotective and anti-inflammatory benefits in MS," he added.

"Considering the distress and limitations spasticity brings to individuals with MS, it would be important to carefully weigh the potential for side effects with the potential for symptom relief, especially in view of the relief reported in subjective assessment," Lakhan said.

Dr. Moses Rodriguez, a professor of neurology and immunology at the Mayo Clinic, said that "the idea of using cannabis to treat MS has been around for a long time."

Rodriguez noted that the effects of using marijuana have been mixed. "It has been difficult to know whether the effect has been just a general well-being or whether it has a direct effect on muscle fibers and spasticity," he said.

If drugs could be developed that take away the intoxicating effects of marijuana, it could have a direct effect on spasms without the high, Rodriguez said.

The Obama administration announced in October that it will no longer prosecute medical marijuana users or suppliers, provided they obey the laws of states that allow use of the drug for medicinal purposes.

Rodriguez said he is often asked by his MS patients about whether there is a benefit to using marijuana.

"What I tell my patients," he said, "is if they want to try it they should try it. They should understand that there is a potential for it to be habit-forming and there may be a potential that they are fooling themselves."

Patricia A. O'Looney, vice president of biomedical research at the National Multiple Sclerosis Society, said the society has studied this issue and does not think enough is known to recommend that MS patients use marijuana.

"Because the studies to date do not demonstrate a clear benefit compared to existing therapy, and issues of side effects and long-term effects are not clear, the recommendation is that it should not be recommended at this time," she said.

Another expert, Dr. William Sheremata, director of the Multiple Sclerosis Center at the University of Miami School of Medicine, also doesn't think MS patients necessarily benefit from marijuana use.

Sheremata noted that the objective measures in the study did not show any benefit from marijuana. "Those are the only valid measures. Subjective responses are subjective; they really don't have much in the way of validity," he said. "I am not convinced that the use of marijuana benefits patients as a whole."

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Drugs

Pros And Cons Of Different

Types Of Drug Tests

by Art Gib

in Health

(submitted 2009-12-01)

0

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There are many types of drug tests, but which one is the best? Let's review the pros and cons of each drug test.

The first type of drug test, and the most commonly used, is the urine drug screen. A urine drug screen is often used in pre-employment drug testing and random drug testing. The pros of this type of test is that it is less expensive than other types, it is non-invasive, it can be tested for a variety of illegal drugs, and most drugs show up in urine within hours of ingestion. The greatest downfall of urine testing is that it can be easily manipulated; therefore, the results cannot always be trusted. Also, because drugs must first be metabolized before they can be detected in urine, an individual who is presently using drugs may still end up with a negative drug test result.

Another type of drug testing is done with a saliva sample. A saliva test is also fairly inexpensive, and because it is nearly impossible to manipulate, a much more reliable method of detecting drug use by an individual. It is very likely that a saliva drug test will completely replace urine testing. The pros are, as mentioned previously, reliability, lower cost, and non-invasiveness. However, it is difficult to detect the presence of certain drugs in a saliva test, specifically, THC and benzodiazepines.

Drug testing using hair samples reveals a wider window of drug use. Drugs metabolized in the body show up in the hair shaft for up to 90 days A small sample of hair, between 90 and 120 strands, is needed for the test, and the results are not affected by shampoo or any other means of manipulation. The hair sample can come from almost anywhere on the body, including arms, legs, and pubic area. The downsides of hair testing is that it takes longer for drugs to show up in the hair than it does in urine, blood, or saliva; it is more expensive than urine and saliva testing; and you must have a lab for results.

A lesser-known type of drug testing is a sweat test. The individual being tested must wear a patch for a prescribed period of time, usually ten days to two weeks. The patch absorbs sweat and, upon removal by a professional, is sent to a lab to be tested for drugs used during the time the patch was worn. The patch has security features that prevent it from being removed and replaced at the end of the test period. Sweat testing is non-invasive and impossible to manipulate. However, some drugs cannot be detected through sweat.

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Drugs

In Women, Aspirin Might Ward Off Eye Trouble

Still, taking it for macular degeneration is not advised, expert says.

By Steven Reinberg
HealthDay Reporter

WEDNESDAY, Dec. 2 (HealthDay News) -- Women who take low-dose aspirin to protect their heart might be helping their eyes as well.

A new study by Harvard University researchers found what they described as a modest benefit for aspirin in preventing age-related macular degeneration (AMD), an eye disease that destroys sharp, central vision.

"The data indicate that long-term treatment with low-dose aspirin has no large beneficial or harmful effect on risk of AMD," said the study's lead researcher, Dr. William G. Christen, an epidemiologist at Brigham and Women's Hospital in Boston and an associate professor of medicine at Harvard Medical School.

"But, the data could not rule out a possible modest benefit," he said.

Researchers have been looking at aspirin to see if it helps or hurts the eyes. Some believe its blood-thinning quality would be helpful in letting more blood reach the capillaries in the eyes. But others have proposed that, in a common form of AMD called wet AMD, in which blood leaks in the back of the eye and results in rapid vision loss, aspirin might increase the risk of bleeding.

For the study, reported in the December issue of Ophthalmology, Christen's group collected data on 39,421 women who took part in the Women's Health Study, which originally focused on heart disease and cancer. None of the women had AMD. They were randomly assigned to take either low-dose aspirin or a placebo.

During the next 10 years, 111 women who took aspirin developed AMD, compared with 134 women who took the placebo. That equates to an 18 percent lower risk for AMD among those who took aspirin, "but the rate difference was not statistically significant," Christen said.

Dr. Stephen G. Schwartz, an associate professor of clinical ophthalmology at the University of Miami's Bascom Palmer Eye Institute, said there have been similar results with aspirin in other eye diseases, such as diabetic retinopathy.

"This also fits in with common clinical experience," he said.

However, Schwartz said he did not think that people should be taking aspirin to try to prevent AMD. The fact that aspirin had little or no effect on AMD is good news, he said.

"If you need to be on aspirin, you should take it and not worry about AMD," he said. "If you don't need to be on aspirin, you probably shouldn't take it."

Another report in Ophthalmology found that common cholesterol-lowering drugs called statins do not stop advanced AMD.

The study's lead researcher, Maureen G. Maguire, from the department of ophthalmology at the University of Pennsylvania, said in a prepared statement that the data "did not support a large effect for statins in decreasing advanced AMD risk in patients who already had large drusen in both eyes."

Drusen are whitish deposits, commonly found in the eyes of people over 60, that could be a sign of AMD. People who used statins were at slightly higher risk for developing advanced AMD than were non-users, she said.

More information

The U.S. National Eye Institute has more on age-related macular degeneration.

(SOURCES: William G. Christen, Sc.D., O.D., epidemiologist, Brigham and Women's Hospital, and associate professor, medicine, Harvard Medical School, Boston; Stephen G. Schwartz, M.D., M.B.A., associate professor, clinical ophthalmology, Bascom Palmer Eye Institute, University of Miami School of Medicine, Miami; December 2009, Ophthalmology
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Drugs

Cetuximab Helps Treat Colorectal Cancer

Drug plus chemo boosts surgery success for patients with liver lesions, researchers find.

WEDNESDAY, Nov. 25 (HealthDay News) -- Adding the drug cetuximab to neoadjuvant chemotherapy can shrink tumors and boost the odds of successful surgery in colorectal cancer patients with inoperable metastatic liver lesions, new research suggests.

Tumors spread to other parts of the body in more than half of patients with colorectal cancer. Most commonly, the cancer spreads to the liver. Removing the tumors in the liver can cure patients, but about 80 percent have inoperable disease and a poor prognosis when they see doctors, the researchers explain in the Nov. 24 online edition of The Lancet Oncology.

Previous research suggests that neoadjuvant treatment with irinotecan- or oxaliplatin-based chemotherapy can make surgery more likely to succeed. The new study aimed to see if addition of the drug cetuximab, also known as Erbitux, would help patients even more.

The study authors, Gunnar Folprecht, from University Hospital Carl Gustav Carus in Dresden, Germany, and colleagues from Germany and Austria found that treatment with cetuximab boosted the proportion of tumors that could be treated with surgery. The treatment, in general, didn't have serious side effects.

"Our data suggest that treatment with cetuximab and chemotherapy results in high confirmed tumor response rates ... leading to ... increased respectability," Folprecht and colleagues wrote. "In the light of recent studies in metastatic colorectal cancer, the value of further treatment intensification will be investigated."

More information

For more about colorectal cancer, visit the U.S. National Cancer Institute.

(SOURCE: The Lancet Oncology, news release, Nov. 24, 2009)

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HealthDayNews articles are derived from various sources and do not reflect federal policy. healthfinder.gov does not endorse opinions, products, or services that may appear in news stories. For more information on health topics in the news, visit Health News on healthfinder.gov.

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Drugs

Proven Heart Vitamins -

Don't Become A Statistic by

David Cassell

in Health

(submitted 2009-11-20)

0

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Ever since we were all children the reminders of taking a vitamin has been engraved in our minds. Whether it was from home, school or by others we all know that vitamins contribute to our well being.

Heart vitamins are specific type of vitamins that can significantly reduce heart disease or attack in the near future. Many people suffer from heart disease and have to spend millions of dollars on medication that often have side effects.

By taking the right supplements now, you are helping your chances of not suffering from a cardiovascular disease.

Among the highly important facts to know are the B vitamin groups. The B6, B9 and B12 vitamins function by helping the body remove hemocysteine from the blood. Therefore for persons who have average health, these B vitamins will boost the overall health of your heart.

Other vitamins such as B3 which is also known as niacin have also been preached as a notable way to drastically reduce high cholesterol levels, which in turn help your heart health.

But what are the other types of vitamin that help mainatin and improve our heart?

Other vitamin types that work in conjunction are Vitamin C and Vitamin E. That's why if you've taken antioxidant vitamins you see these type of vitamins all-together. They help repair damage cells in the body and help improve other body components that are vital for well being.

Many multi-vitamin products found in retail shops and supermarkets do have many of the vital vitamins for heart health. The problem is that these vitamins are not in a bio-available form.

This means that if you consume these heart vitamins, your body doesn't recognize it as food so your body ends up only absorbing a small amount. Most of it is passed out as waste.

By the way, did you know that most of the vitamins sold in drugstores and superstores like Walmart are made by just two mnaufacturers. That is right.

If you want to get into the vitamin business, all you need to do is to contact these companies and apply your own label to the product.

This is why the majority of drug store supplements don't work that well. They are poorly formulated and hence very cheap.

It is therefore highly important to research the manufacturers of supplements and find out what process they use to manufacture pills.

The closer the supplement is to food, the more your body will accept it. The more your body accepts it, the more that supplement benefits your body.

When it comes to heart health vitamins assure yourself that the ingredients have been evaluated by an organization like United States Pharmacopeia (USP) or some such body in your country.

You will get the most value out of your money that way and assure yourself of buying a good heart health improvement vitamin!

About the Author

For a healthy heart, lower blood pressure and lower cholesterol, click here

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Drugs

Drug-resistant swine flu hits UK

By Fergus Walsh
Health correspondent, BBC News

Health officials say a Tamiflu-resistant strain of swine flu has spread between hospital patients.

Five patients on a unit treating people with severe underlying health conditions at the University Hospital of Wales, Cardiff, were infected.

Three appear to have acquired the infection in hospital.

They are thought to be the first confirmed cases of person-to-person transmission of a Tamiflu-resistant strain in the world.

There have been several dozen reports around the world of people developing resistance to Tamiflu while taking the drug - but they have not passed on the strain to others.

Just one possible cases of person-to-person transmission of a resistant strain has been recorded - between two people at a US summer camp - and this has never been confirmed.

Two of the University Hospital Wales patients have recovered and have been discharged from hospital, one is in critical care and two are being treated on the ward.

The health officials stressed there was no risk to anyone else.

They said tests were being carried out to confirm exactly what happened.

The UK has bought enough doses of Tamiflu, which can shorten the duration of swine flu and reduce the risk of complications, for half the population.

Serious concern

So any spread of a Tamiflu-resistant strain of the illness is a serious public health concern.

The H1N1 virus has been remarkably stable since it emerged in April, but virologists had been half expecting new resistant strains to emerge.

Dr Roland Salmon, director of the National Public Health Service for Wale's Communicable Disease Surveillance Centre, said: "The emergence of influenza A viruses that are resistant to Tamiflu is not unexpected in patients with serious underlying conditions and suppressed immune systems, who still test positive for the virus despite treatment.

"In this case, the resistant strain of swine flu does not appear to be any more severe than the swine flu virus that has been circulating since April."

Dr Tony Jewell, Chief Medical Officer for Wales, said: "We know that people with suppressed immune systems are more susceptible to the swine flu virus, which is why they are a priority group under the first phase of the vaccination programme in Wales which is progressing at pace.

"We have stringent processes in place for monitoring for antiviral resistance in the UK so that we can spot resistance early and the causes can be investigated and the cases managed.

"Identifying these cases shows that our systems are working so patients should be reassured.

"Treatment with Tamiflu is still appropriate for swine flu and people should continue to take Tamiflu when they are prescribed it.

"It's also important that good hygiene practices are followed to further prevent the spread of the virus."

Professor Peter Openshaw, a respiratory physician at Imperial College London, said of the spread: "It's not surprising that this has happened, indeed it has always been anticipated".

Dr Ronald Cutler, deputy director of biomedical science at Queen Mary, University of London, said: "Shortening the time taken to produce new vaccines and improving the methods to control and treat the disease while vaccines are being made would be a way forward".

On Thursday it was announced that more than three million healthy children under five across the UK will be offered the swine flu jab.

Figures released on Thursday showed an estimated 53,000 new cases of swine flu in England in the last week, down from 64,000 in the week before.

In Scotland, the figure was 21,200, down from about 21,500 in the previous seven days.

The rate of flu-like illnesses diagnosed by GPs in Wales dropped to 36 cases for every 100,000 people from 65.8 the previous week.

Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/2/hi/health/8370859.stm

Published: 2009/11/20 17:14:49 GMT

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Drugs

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Athletes Seeking Doping Agents Can Still Find Them Online Banned products are readily available, researchers say. FRIDAY, Nov. 20 (HealthDay News) -- Unapproved non-steroidal and tissue-selective anabolic drugs called selective androgen receptor modulators (SARMs) are being sold on the Internet as sports doping agents, according to a new report. Though SARMs offer promise for the treatment of a number of diseases -- including osteoporosis, sarcopenia, benign prostatic hyperplasia and cancer cachexia (a wasting syndrome) -- none of the agents have yet been approved for use in patients, according to background information in the study. However, some athletes who use doping products believe SARMS offer the performance benefits of traditional anabolic/androgenic steroids, such as testosterone, with fewer side effects. SARMs were banned by the World Anti-Doping Agency in 2008. In the new study, published online Nov. 19 in the journal Drug Testing and Analysis, researchers in Germany analyzed a product they bought on the Internet, which was delivered in a box labeled as containing face moisturizer and green tea extract. But the product was actually a non-approved arylpropionamide-derived SARM called Andarine, according to the study. "Major concerns result from these findings," study author Mario Thevis, of the German Sport University Cologne, said in a news release from the journal's publisher. "This product with considerable anabolic properties is readily available without sufficient research on its undesirable effects; this is especially significant where uncontrolled dosing is applied and drug impurities with unknown effects are present in considerable amounts as observed in the studied material." More information The U.S. Office of National Drug Control Policy has information on anabolic steroids. (SOURCE: Drug Testing and Analysis, news release, Nov. 19, 2009 ) Copyright © 2009 ScoutNews, LLC. All rights reserved. HealthDayNews articles are derived from various sources and do not reflect federal policy. healthfinder.gov does not endorse opinions, products, or services that may appear in news stories. For more information on health topics in the news, visit Health News on healthfinder.gov. http://healthcareman-dobi.blogspot.com/search/label/drugs