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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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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Wider Waistlines Linked to Memory Problems in HIV Patients

MONDAY, Feb. 13 (HealthDay News) -- HIV-positive patients with larger waistlines may be at greater risk for memory problems, according to a new study. Exposure to combinations of certain anti-HIV drugs could play a role in this reduced mental function, researchers said.

"Interestingly, bigger waistlines were linked to decreased mental functioning more than was general obesity," said study author Dr. J. Allen McCutchan, at the University of California, San Diego, in a journal news release. "This is important because certain anti-HIV drugs cause weight gain in the center of the body that is most dramatic in the abdomen, neck, chest and breasts."

Researchers looked at 130 HIV-positive patients who were about 46 years old and who had been infected for an average of 13 years. Most patients were on antiretroviral therapy consisting of combinations of anti-HIV drugs.

Forty percent of the participants had "neurocognitive impairment" -- reduced mental function such as poor memory and/or concentration. These patients also had a waist measuring an average of 39 inches.

In contrast, patients with normal mental function had an average waist size of 35 inches.

The study appears in the Feb. 14 issue of the journal Neurology.

"Avoiding those HIV drugs that cause larger waistlines might protect or help to reverse [mental impairment]," McCutchan said. "We don't know if central obesity is causing [the problem] directly or is just a marker for exposure to a more direct cause such as anti-HIV drugs. People with HIV should talk to their doctors before considering changes in their anti-HIV medications."

The study authors pointed out that reduced mental function was also linked to older age, a longer time living with HIV and diabetes in patients older than 55.

More information

The U.S. Centers for Disease Control and Prevention provides more information on HIV/AIDS.

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'Hunger hormone' could help chemo patients: study

NEW YORK (Reuters Health) - A synthetic version of the "hunger hormone" ghrelin might help limit the loss of appetite that can come with cancer chemotherapy, a small study from Japan suggests.

Ghrelin is a hormone secreted by the gut to boost appetite. Because of that, scientists have been studying it as a target in the obesity war, which has included work on an anti-obesity "vaccine" that inhibits ghrelin. But the research has met with little success so far.

Since the hormone spurs hunger, in theory, infusions of synthetic ghrelin could help prevent the sometimes severe appetite loss caused by cancer drugs.

In particular, a commonly used cancer drug called cisplatin often causes nausea, vomiting and appetite loss -- and cuts the body's natural ghrelin levels.

For the new study, Japanese researchers tested the effects of ghrelin infusions in 41 patients undergoing cisplatin treatment for advanced cancer of the esophagus.

Half of the patients were randomly assigned to have ghrelin infusions twice a day, before their meals, over one week of chemotherapy. The rest were given infusions of saline.

In the end, the ghrelin patients maintained better appetites and were able to take in almost 50 percent more calories per day than patients given saline.

Overall, more than half of the saline group had nausea, versus one in five ghrelin patients. And while half of the saline group had anorexia -- significant appetite loss -- during chemo, only one in six ghrelin patients did.

Dr. Yuichiro Hiura and colleagues at Osaka University report their findings in the journal Cancer. The study was funded by a grant from the Japanese government.

It appears to be the first to show that ghrelin may help cancer patients being treated with cisplatin, so further studies are needed, the researchers say.

There is already a medication -- one that decreases the activity of the hormone serotonin -- that eases nausea and vomiting in the first 24 hours of cisplatin treatment, Hiura's team notes.

But, they add, lingering nausea and appetite loss in the following days are still a challenge to control. So ghrelin could offer a way to help with those longer-term effects.

Intensive chemotherapy with multiple drugs, including cisplatin, is commonly used for advanced-stage cancer, Hiura's team writes. But side effects may keep many patients from completing their treatment.

Ultimately, the researchers say, the goal is to make chemotherapy easier for patients to get through -- and, it's hoped, improve the treatment's effectiveness.

SOURCE: http://bit.ly/wB771x Cancer, online January 26, 2012.

View the original article here

'Hunger hormone' could help chemo patients: study

NEW YORK (Reuters Health) - A synthetic version of the "hunger hormone" ghrelin might help limit the loss of appetite that can come with cancer chemotherapy, a small study from Japan suggests.

Ghrelin is a hormone secreted by the gut to boost appetite. Because of that, scientists have been studying it as a target in the obesity war, which has included work on an anti-obesity "vaccine" that inhibits ghrelin. But the research has met with little success so far.

Since the hormone spurs hunger, in theory, infusions of synthetic ghrelin could help prevent the sometimes severe appetite loss caused by cancer drugs.

In particular, a commonly used cancer drug called cisplatin often causes nausea, vomiting and appetite loss -- and cuts the body's natural ghrelin levels.

For the new study, Japanese researchers tested the effects of ghrelin infusions in 41 patients undergoing cisplatin treatment for advanced cancer of the esophagus.

Half of the patients were randomly assigned to have ghrelin infusions twice a day, before their meals, over one week of chemotherapy. The rest were given infusions of saline.

In the end, the ghrelin patients maintained better appetites and were able to take in almost 50 percent more calories per day than patients given saline.

Overall, more than half of the saline group had nausea, versus one in five ghrelin patients. And while half of the saline group had anorexia -- significant appetite loss -- during chemo, only one in six ghrelin patients did.

Dr. Yuichiro Hiura and colleagues at Osaka University report their findings in the journal Cancer. The study was funded by a grant from the Japanese government.

It appears to be the first to show that ghrelin may help cancer patients being treated with cisplatin, so further studies are needed, the researchers say.

There is already a medication -- one that decreases the activity of the hormone serotonin -- that eases nausea and vomiting in the first 24 hours of cisplatin treatment, Hiura's team notes.

But, they add, lingering nausea and appetite loss in the following days are still a challenge to control. So ghrelin could offer a way to help with those longer-term effects.

Intensive chemotherapy with multiple drugs, including cisplatin, is commonly used for advanced-stage cancer, Hiura's team writes. But side effects may keep many patients from completing their treatment.

Ultimately, the researchers say, the goal is to make chemotherapy easier for patients to get through -- and, it's hoped, improve the treatment's effectiveness.

SOURCE: http://bit.ly/wB771x Cancer, online January 26, 2012.

View the original article here