So what efforts go behind the scene till a new drug hits the market? Do patients benefit ? Are they cured? How do we control health care costs? What are the new drugs in the making?
Here are some highlights from current pharma and clinical research news, views and data-
Aspirin may boost survival, cut risk of recurrence in breast cancer survivors.
A new study says breast cancer survivors who take aspirin regularly may be less likely to die or have their cancer return." The researchers found that "women who had been diagnosed with early breast cancer and who just happen to be taking aspirin, somewhere between two and five days, had a 50% reduction in dying of the breast cancer." In women who took "aspirin just once a week, there was no benefit," but, those who took "aspirin two to five times a week" experienced a 71 percent reduction in dying from a return of the cancer.
The study of 4,164 breast cancer patients, published in the Journal of Clinical Oncology, showed that those "who took aspirin two to five days per week were 60 percent less likely to have a recurrence and 71 percent less likely to die from the disease."The findings challenge "at least five large studies" that "have shown that taking aspirin regularly has no effect on the risk of developing breast cancer in the first place. The researchers said that aspirin may help control cancer by fighting inflammation,as breast cancers produce more inflammatory chemicals than normal breast cells.But, they cautioned that more research is needed to confirm the findings before recommending that breast cancer patients take aspirin to increase their chances of surviving.
The study did not ask women what dose of aspirin they were taking, nor why they were taking it." The findings "also suggested other nonsteroidal anti-inflammatory drugs...may reduce breast cancer recurrence, although that effect was evident only in women who took those medicines 6 to 7 days a week." Notably, "no link could be established between acetaminophen...and reduced breast cancer mortality."
Discovery Laboratories to run additional preclinical trials for respiratory stress syndrome drug.
Following discussions with the FDA, "Discovery Laboratories Inc. said Tuesday it won't have to run new clinical trials of its respiratory stress syndrome treatment Surfaxin [lucinactant], which could save the company money and help get the drug approved sooner." Discovery Labs also "said it will focus on testing the drug on prematurely born lambs instead of premature infants." Discovery will conduct additional preclinical studies, rather than a limited clinical trial.
Additional trials may underscore prostate cancer drug's early successes.
Further tests have underlined abiraterone's "potential" as a prostate cancer drug, and "larger trials are underway." If the latest trials prove "successful, it could be prescribed to men in the advanced stages of the disease as early as next year, giving them the hope of precious extra months with their families.In a phase II study, about half of the 47 men given abiraterone experienced a substantial reduction in levels of prostate specific antigen in their blood.
Statins may increase diabetes risk.
According to a study published online Feb. 17 in The Lancet, statins may increase the risk of developing diabetes. After analyzing 13 studies of statins encompassing "more than 90,000 patients," researchers found that "the risk" for developing diabetes is "tied to the entire class of medications, and the danger increases with age."
"More than six million adults currently taking statins are being advised to carry on taking them by researchers and leading medical charities, who stress that the benefits far outweigh the risks, specifically, "researchers say that treating 255 patients with statins for four years results in one extra case of diabetes, but saves five major coronary events, such as heart disease death or heart attack." Nevertheless, "the review will put the brakes on growing calls for statins to be given to 'healthy' people.
Botox may help prevent some types of migraines.
Allergan Inc.'s Botox [botulinum toxin type A], given in the doses used to reduce facial wrinkles, may stop certain kinds of migraines that patients describe as crushing or 'eye-popping' more than other types," according to research published in the Archives of Dermatology. The company "has filed for approval with the [FDA] to market Botox as a treatment for chronic migraines...said" a spokeswoman for Allergan. A study of 18 patients showed that 13 "saw a reduction in migraine pain," from "almost seven days a month to less than one day a month." Researchers speculated that Botox "may work by blocking pain receptors or reducing inflammation." MedPage Today (2/15, Bankhead) also covered the story.