Astra takes brand cancer drug straight to patients

(Reuters) - AstraZeneca Plc is selling breast cancer drug Arimidex directly to U.S. patients, offering an option for people who want to pay for the brand instead of generic versions.

Under the drugmaker's new program, patients with a prescription can pay $40 a month for Arimidex to be mailed to their homes.

That is less than patients would generally pay for the brand, but is typically more than the co-payment for generic versions of the drug, also known as anastrozole.

AstraZeneca said it started the program in response to patients asking for options to buy the brand, which are prohibitively more expensive compared with generics since the cheaper copies became available in mid-2010.

"We definitely got lots of calls every month to our information center on how they could get a branded option," said Steve Davis, Astra's executive director overseeing its mature brands in the United States. "There are patients that prefer not to be on the generic option."

Health plans generally try to steer patients to generic versions once they become available because they are significantly less expensive.

AstraZeneca's move is similar to one by Pfizer Inc, which has offered delivery of brand versions of its Lipitor drug to patients after the big-selling cholesterol treatment lost U.S. patent protection in November.

Arimidex was once a big seller for Astra. In 2009, the last full year before generics arrived, Arimidex sales reached $1.9 billion globally and about $880 million in the United States alone. Last year, Astra's U.S. sales of the drug fell 91 percent to $42 million, reflecting the toll taken by generic rivals.

In Arimidex's class of drugs, known as aromatase inhibitors, some 96 percent of prescriptions are generic, Davis said.

A major wrinkle in the Arimidex Direct program is that patients do not use their health insurance to get their pills, but pay out of pocket. AstraZeneca is contracting with Express Scripts Inc, a pharmacy benefit management company that mails the prescription to patients.

At $40 a month, the price is more than the usual $10 co-pay for generics, but less than insured patients would otherwise pay for the brand, which may only be available at close to the full price, according to Express Scripts.

Drugstore.com lists a one-month supply of Arimidex at $458.97 and anastrozole at $186.01.

"Given the seriousness of the condition, there may be individuals who are willing to pay $40 for the brand," said Everett Neville, chief trade relations officer Express Scripts. "That's completely different than you might see with some less emotionally charged conditions."

Aromatase inhibitors are used to treat breast cancer or help keep breast cancer from recurring after surgery, according to the American Cancer Society.

Davis said AstraZeneca started the program late last year, initially marketing it through brochures left in oncologists' offices and wanted to make sure it was working smoothly before publicizing it. About 300 patients are enrolled so far.

"This is a very emotional disease and it brings a lot of patient concerns," Davis added. "There is brand loyalty."

(Reporting By Lewis Krauskopf; editing by Andre Grenon)

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Dietary Help Can Boost Cancer Patients' Nutrition, But Not Survival

WEDNESDAY, Feb. 15 (HealthDay News) -- Good dietary advice and supplements can boost nutrition while improving quality of life in malnourished cancer patients, a new study finds.

However, the interventions do not appear to affect survival for these patients, according to the findings published in the Feb. 15 issue of the Journal of the National Cancer Institute.

For the study, Christine Baldwin, a lecturer in the nutritional sciences division at King's College London, and colleagues analyzed data from 13 clinical trials that included a total of more than 1,400 cancer patients who were malnourished or at risk of malnutrition. Some of the patients received oral nutritional support (dietary advice and/or supplements) while others received routine care.

Oral nutritional support had a wide range of effects on both weight and energy intake, and led to improvements in aspects of quality of life, such as emotional functioning, shortness of breath and loss of appetite. However, this type of intervention had no effect on patient death rates, the study authors noted in a journal news release.

The level of benefit varied between patients, and the authors concluded that "it is likely that the factors such as site and stage of disease and, indeed, variations in the duration, nature and intensity of the nutritional intervention will account for difference in effects in patients."

International guidelines have suggested oral nutritional intervention for malnourished cancer patients or those who are at nutritional risk, but these suggestions are based largely on expert opinion as opposed to clinical trials, according to background information in the study.

Commenting in an editorial accompanying the study, Ann O'Mara and Diane St. Germain of the U.S. National Cancer Institute wrote that "until future research provides clearer answers regarding who will benefit from nutritional interventions, the use of a comprehensive assessment, published nutritional guidelines and early interventions are essential."

More information

The American Cancer Society has more about cancer patients and nutrition.

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No Cancer Benefit From Vitamin B, Omega-3 Supplements in Heart Patients

MONDAY, Feb. 13 (HealthDay News) -- Patients with a history of heart disease will most likely not reduce their risk for developing cancer by taking vitamin B and/or omega-3 fatty acid supplements, a new French analysis suggests.

"In the population we studied, we found no beneficial effects of either B vitamins or omega-3 fatty acids taken over five years on cancer occurrence or cancer-related death," noted study author Valentina Andreeva, who is with the nutritional epidemiology research unit at the University of Paris XIII in Bobigny, France.

Andreeva and her colleagues report their findings in the Feb. 13 online edition of the Archives of Internal Medicine.

To explore the protective potential of B vitamins and fatty acid supplements, the authors did a secondary analysis of data that had been collected in a previous study involving almost 2,000 French men and 500 women.

All were between 45 and 80 years of age, and all had experienced cardiac trouble (heart attack, unstable angina or ischemic stroke) in the year leading up to the start of the study.

In turn, the participants were divided into one of four different groups that consumed a daily supplement regimen involving various types of vitamin B and omega-3 fatty acids at "relatively low supplementation doses."

By the end of the original five-year study, 7 percent of the participants had gone on to develop some form of cancer, and just over 2 percent ultimately died of cancer. The vast majority of cancer cases (including prostate, lung, bladder and colorectal cancer) and deaths occurred among men (81 percent and 83 percent, respectively).

The team unearthed no evidence that any form of vitamin B or omega-3 fatty acid supplement improved cancer outcomes in any way.

The investigators noted that there were some indications that cancer risk might have actually gone up, specifically among women taking vitamin B and/or omega-3 fatty acid supplementation. However, the authors stressed that this observation was based on too few cases to substantiate a firm conclusion, and called for further research involving a larger pool of participants.

"The results of our study suggest that individuals should exercise caution when deciding to take dietary supplements, especially over a long period of time and without a physician's advice," advised Andreeva. "Such supplements constitute active substances and might have adverse effects in some populations. To be on the safe side, individuals should strive to achieve dietary recommendations via healthy, balanced diets."

Joseph Su, the Washington, D.C.-based program director of the division of cancer control and population science within the U.S. National Cancer Institute's epidemiology and genomics research program, said that nothing about the findings struck him as surprising.

"So far, study findings have been very inconsistent," he noted. "But most supplement studies, if anything, have shown no beneficial effect whatsoever. Just like this one. So, I don't think there's anything that can really back up the idea that these supplements can prevent cancer."

However, Vicky Stevens, strategic director of laboratory services at the American Cancer Society in Atlanta, expressed some reservations about the French analysis.

"Compared with other trials, they used much lower levels of supplements," she noted. "From the B-vitamin point of view, dramatically lower. So, it could be argued that they just weren't using high enough levels of supplements to see any effects," Stevens suggested.

"And they used a natural form of folate [vitamin B supplement], whereas other trials use a synthetic form," Stevens added. "But the real problem in being able to evaluate the effects they do see is that they don't have enough people. And it's not really a long enough follow-up period to really see an effect of these supplements on cancer onset. Five years isn't really enough. It can take 10 or 20 years in most cases. So, what they may be seeing is an effect on preexisting abnormalities, but not the impact on cancer onset itself."

Duffy MacKay, a naturopathic doctor and vice president of scientific and regulatory affairs for the Council for Responsible Nutrition in Washington, D.C., agreed.

"When you look at an intervention like this, you're definitely not looking at the role of the supplements at preventing tumors, because the tumors likely started well before the trial," he noted. "So really what the trial is about is giving vitamin B and omega 3 and seeing if they altered the outcome, the progression, of these cancers," MacKay explained.

"And with that you have to realize that cancer is a very complex multi-factorial disease," MacKay stressed. "And two supplements would never be expected to be a successful treatment on their own. I would say, however, that proper nutrition is one of your best allies in terms of wellness, period. And while no one ever claimed these were cancer drugs, if you will, supplements make sense, cancer or no cancer."

More information

For more on vitamins and cancer, visit the American Cancer Society.

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Patients Clamor for Cancer Drug That Shows Promise for Alzheimer's in Mice

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PET_Alzheimer1

PET image of an Alzheimer's brain

The pharmaceutical industry has beat a concerted retreat from developing drugs for diseases that affect the brain, stymied by the lengthy development times for these agents and a string of failures. Despite the evident risks, a new study shows how industry leaders should perhaps be taking the long view.

The report online last week in Science that an already approved cancer drug showed promise in mice in correcting both the molecular pathology and cognitive decline of Alzheimer’s has patients and their families clamoring for the compound.

Those suffering are asking by the hundreds for the drug despite warnings that evidence in mice often does not translate into later success in humans. Gary Landreth of Case Western Reserve University received a flood of requests from desperate families.

Landreth, the lead researcher on the study, did not hype the results. He acknowledged that bexarotene rapidly cleared the toxic amyloid peptides and seemed to improve cognition in mice. But he also emphasized that rodents differ from humans and that examining whether the drug can eliminate amyloid in a small human trial must be demonstrated now before moving forward to a larger test to ascertain whether cognition improves as well. In our story last Thursday, Landreth cautioned:

“Don’t try this at home because we don’t know what dose to give, we don’t know how frequently to give it, and there are a few nuances to its administration. So one shouldn’t be prescribing it off-label.”

It is also unclear whether a drug like bexarotene, even if it were a success for patients in the early stages of the disease, would work later as the pathology progresses and nerve cells start to perish.

The fallout from this story turned up in our comments section. One reader, identified only as Jeff_Davis, responded to another’s remarks by saying:

“You write: …’I'd be very worried about off-label use…’

“I guarantee you, this is way past ‘worry.’ A tsunami of off-label use is underway even as we speak. Friends, already in the grip of the Alzheimer’s horror — loved ones in their care, mostly — are already in contact with their physician, saying, ‘Will you prescribe this drug, or do I have to find someone who will?’”

The Case Western Reserve researchers are heading up an effort to move the drug quickly into human trials. Things should move along at a good clip because the safety profile is relatively well known for this nearly 13-year-old drug.

Patients and their families should hold tight because without drug trials that conform to well-established testing protocols, it will be impossible to know whether a drug originally approved for cutaneous T cell lymphoma will work for Alzeheimer’s. Using the drug off label now will be be like ingesting nothing more than a sophisticated dietary supplement. At the same time, drug manufacturers should take notice of the huge pent-up demand and think twice about scrapping their neuro development programs.

Image: Wikipedia Commons

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Smoking May Up Cancer Risk in Barrett's Esophagus Patients

FRIDAY, Feb. 10 (HealthDay News) -- People with the condition called Barrett's esophagus who are smokers may have double the risk of developing esophageal cancer, a new study warns.

These people also have twice the risk of developing advanced precancerous cells, according to the study in the February issue of Gastroenterology.

"We found that tobacco smoking emerged as the strongest lifestyle risk factor for cancer progression. Contrary to popular belief, alcohol consumption didn't increase cancer risk in this group of patients with Barrett's esophagus," lead author Helen Coleman, of Queen's University Belfast in Northern Ireland, said in a news release from the American Gastroenterological Association.

In people with Barrett's esophagus, damage caused by stomach acid causes the lining of the esophagus to become similar to the lining of the stomach, according to the U.S. MedlinePlus Medical Encyclopedia. Most people with Barrett's esophagus do not develop esophageal cancer.

For the study, researchers looked at more than 3,000 Barrett's esophagus patients worldwide and identified 117 cases of dysplasia or cancers of the esophagus or stomach.

Current smoking, regardless of the number of cigarettes smoked per day, was significantly associated with an increased risk of esophageal cancer. Therefore, cutting down on cigarette consumption may not be enough to reduce the risk of esophageal cancer in people with Barrett's esophagus, the researchers suggested.

"Tobacco smoking has been long established as highly carcinogenic," Coleman said. "Barrett's esophagus patients who smoke should start a cessation program immediately."

Although the study authors pointed out that more research is needed to confirm the findings, and the association noted in the study did not prove a cause-and-effect relationship between smoking and esophageal cancer in these patients, Coleman's team suggested that smoking should be discouraged.

The investigators also noted that developed countries have seen a rise in the incidence of esophageal cancer.

More information

The U.S. National Cancer Institute has more about esophageal cancer prevention.

View the original article here

Smoking May Up Cancer Risk in Barrett's Esophagus Patients

FRIDAY, Feb. 10 (HealthDay News) -- People with the condition called Barrett's esophagus who are smokers may have double the risk of developing esophageal cancer, a new study warns.

These people also have twice the risk of developing advanced precancerous cells, according to the study in the February issue of Gastroenterology.

"We found that tobacco smoking emerged as the strongest lifestyle risk factor for cancer progression. Contrary to popular belief, alcohol consumption didn't increase cancer risk in this group of patients with Barrett's esophagus," lead author Helen Coleman, of Queen's University Belfast in Northern Ireland, said in a news release from the American Gastroenterological Association.

In people with Barrett's esophagus, damage caused by stomach acid causes the lining of the esophagus to become similar to the lining of the stomach, according to the U.S. MedlinePlus Medical Encyclopedia. Most people with Barrett's esophagus do not develop esophageal cancer.

For the study, researchers looked at more than 3,000 Barrett's esophagus patients worldwide and identified 117 cases of dysplasia or cancers of the esophagus or stomach.

Current smoking, regardless of the number of cigarettes smoked per day, was significantly associated with an increased risk of esophageal cancer. Therefore, cutting down on cigarette consumption may not be enough to reduce the risk of esophageal cancer in people with Barrett's esophagus, the researchers suggested.

"Tobacco smoking has been long established as highly carcinogenic," Coleman said. "Barrett's esophagus patients who smoke should start a cessation program immediately."

Although the study authors pointed out that more research is needed to confirm the findings, and the association noted in the study did not prove a cause-and-effect relationship between smoking and esophageal cancer in these patients, Coleman's team suggested that smoking should be discouraged.

The investigators also noted that developed countries have seen a rise in the incidence of esophageal cancer.

More information

The U.S. National Cancer Institute has more about esophageal cancer prevention.

View the original article here