For plants and animals forced to tough out harsh winter weather, the coverlet of snow that blankets the north country is a refuge, a stable beneath-the-snow habitat that gives essential respite from biting winds and subzero temperatures.
Source: University of Wisconsin-Madison – Discipline: Ecology… … www.labspaces.net… Read On
As most people agree that the best way to beat cancer is to prevent it, the United States have reached some important cancer prevention milestones during the past year.
Here are some of them, as reported in Galvestondailynews:
1. Lung cancer screening is now a reality.
To make sure whether you are free from developing lung cancer or not – due to the history of smoking, The National Lung Screening Trial in the US showed that a CT scan can be performed for some smokers and former smokers to detect lung cancer at an early stage. This way, we can surely reduce the chances of death.
But since lung cancer screening is not for everyone, you need to find out if you should get screened or not.
2. Health care reform makes preventing cancer more affordable.
With the reform of the health care, it should be much less costly now to get cancer screening exams and adopting healthy habits to reduce cancer risks.
Many health insurance plans in the US now provide preventive services without requiring a co-pay, coinsurance or a deductible. So with less cost, it should be easier for people to get help regarding diet improvement to lose weight, or a guidance to quit smoking, and other lifestyle changes that can help prevent cancer.
3. Proactive approach on avoiding everyday toxins.
The basic idea is: It’s better to be safe than sorry. As according to Margaret L. Kripke, co-writer of the report and professor emeriti at M.D. Anderson Cancer Center, people never know how much environmental factors can contribute to new cancer cases, therefore proactive approach like finding ways to reduce contact with toxic chemicals and radiation are advised to take. The approach is suggested in the 2010 President’s Cancer Panel Report.
4. Hormone therapy use to reduce cancer risks.
Women who take combined hormone therapy have been proven to have a higher risk of breast cancer. After a 15-year study regarding estrogen and progestin therapy, the Women’s Health Initiative confirmed the longer women use the therapy, the more cancer risk appears to increase.
However, instead of taking progestine-alone therapy – which may increase the breast cancer risk, taking estrogen-alone therapy for a short term is actually safe and does not increase the risk of breast cancer.
5. Smoking bans in half of all states.
Smoking bans are growing rapidly in numbers of states, where in these states smoking in public areas and work places are not allowed. According to the Centers for Disease Control and Prevention, if the progress continues, the entire country could have laws banning smoking in all indoor areas by 2020.cancer.womendiary.net … Read On
During the Rutgers Business School’s annual healthcare symposium, an FDA official encouraged industry to put its drugs on the reviewing table and be prepared for good news.
On a panel titled “Activist FDA: Transformation Agent,” Prevision Policy founder and former Pink Sheet editorial head Cole Werble relayed the tale of Acadia Pharmaceuticals, a San Diego-based company with a stage three compound (pimavanserin) targeting Parkinson’s disease-related psychosis.
A month ago, Acadia met with FDA to discuss the proper design of a new phase III trial intended to confirm the results of a previous, 17-month study that met its primary endpoints. A confirmation trial was needed, Acadia presumed, since the first phase III trial of pimavanserin, conducted in 2009 at half the dose of the successful trial, had failed. Acadia had already begun to enroll patients in the confirmation trial – which represented an $18 million commitment – when it met with FDA in April to get the agency’s blessing.
To Acadia’s surprise, FDA responded that the additional confirmation trial wouldn’t be necessary, based on the pivotal phase III trial already on the books, combined with supportive data from other studies on pimavanserin. As a result, Acadia scrapped plans to do another trial, and began preparing its NDA posthaste. But the company wasn’t hasty enough, and investors dialing in to a call about the FDA meeting balked at the company’s projected filing date – near the end of 2014. Why not file immediately, they wanted to know? Acadia executives’ refrain in response, was, “these things take time.” The company FDA had reversed the waiting game, making Acadia itself responsible for the delay in review and commercialization of a new product.
This is just one example, of course; it isn’t likely that a big pharma looking to introduce another DPP4 into the market for type 2 diabetes, for example, would be told not to worry about additional trials studying cardiovascular or pancreatic side effects. But the fact remains that FDA approved 39 NDAs in 2012 – the most since 1997 – and the agency launched yet another expedited regulatory pathway – breakthrough therapies – at the beginning of 2013. The breakthrough therapies designation is likely to shorten the timeline from discovery to commercial approval – for those drugs receiving the designation – to between three and five years, according to IMS estimates.
Rachel Sherman, associate director of medical policy and director of the Office of Medical Policy, CDER, FDA
The timeline from discovery to approval could be as short as 26 months, said Rachel Sherman, FDA’s associate director of medical policy at the Center for Drug Evaluation and Research (CDER). Sherman said her office had received – to date – 39 requests for breakthrough therapy status, of which 12 have been granted and 14 denied, with 11 pending and two withdrawn. She said the breakthrough therapies program is already “an enormous success.”
Joseph Herring, CEO at Covance, noted that pharmaceutical companies are often difficult to work with, from his perspective as the head of a CRO. “[Investigators] want a perfect trial that can’t be enrolled.” He wondered about the interplay companies have with FDA regarding trial design discussions. In response, Sherman advised more communication. “If what we say doesn’t make sense, ask us. Argue with us. We’re receptive to it.”
How does a company know whether it’s sufficiently engaged with FDA? “If your lead clinical person is on a first name basis with the [respective] lead reviewer at FDA, you’re in good shape,” said Sherman. “If you’re not, you’re not.” Sherman cited the Clinical Trials Transformation Initiative as another program aimed at “identifying and promoting practices that will increase the quality and efficiency of clinical trials.”
“The point of all our programs is better evidence generation…we lack evidence,” said Sherman. “The most expensive drug is the one given to the wrong patient, or given incorrectly.”
On the subject of biosimilar approvals, Sherman said FDA hasn’t received a single application yet, adding that the phrase “follow-on biologics” is dead. The requirements for biosimilars, according to Sherman, are that a biosimilar be “highly similar” to the original product, with “no clinically meaningful differences.” Sherman said that does not mean “interchangeability,” though, suggesting that a biosimilar could not be substituted for a brand biologic at the pharmacy, without specific doctor’s orders.
Comparing the current activist FDA with the activism the agency demonstrated during the HIV epidemic, Werble said that in addition to the breakthrough therapies designation, FDA has also launched the GAIN ACT, and its anti-infective exclusivity provision; has opened up FDA meetings to rare disease outside consultants, who advise companies on efficient FDA regulatory navigation; and has implimented PDUFA 5’s “patient-focused drug development meetings,” which solicit patient opinions around specific diseases.
Speaking on the “agency-wide impact of management attention and staff commitment” mustered during the HIV crisis 20 years ago, Werble said the pendulum has once again swung back toward FDA activism. “That commitment [to HIV] was infectious 20 years ago, and it’s occurring again,” said Werble. He also noted that a solid one-third of all drug applications submitted to FDA now come from small companies, a rejection of the thesis that only big pharma is properly equipped to navigate FDA’s regulatory structure.
The Rutgers Business School Annual Healthcare Symposium, convened on April 30, was presided over by Mahmud Hassan, director of the Blanche and Irwin Lerner Center of the Study of Pharmaceutical Management Issues. John Castellani, president and CEO of PhRMA, and Seyed Mortazavi, president of IMS Health US operations, also gave presentations.blog.pharmexec.com … Read On