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PhRMA: Cancer drug ‘failures’ are a critical part of the drug development process

BY Michael Johnsen

WASHINGTON — The Pharmaceutical Research and Manufacturers of America on Tuesday released a new report, “Researching Cancer Medicines: Setbacks and Stepping Stones,”  which highlights the number of investigational cancer medicines that did not succeed in clinical trials and how these “failures” are a critical part of the drug development process. 

The report illustrates the immense challenges in bringing new medicines to patients with cancer, and explores the factors that contributed to both the approvals of new treatments and those that “failed” between 1998 and 2014. The report focuses on three cancers that are particularly difficult to treat: melanoma, lung cancer and brain cancer.
 
Findings include:
 
  • 96 potential treatments for melanoma did not make it through clinical trials, but paved the way for 7 approved medicines, a nearly 14:1 ratio of “failures” to “successes”;
  • 10 medicines have been approved to treat lung cancer, whereas 167 other potential treatments did not make it through clinical trials; and
  • Only 3 new medicines have been approved to treat brain cancer, while another 75 investigational medicines were unsuccessful in the development process.
 
Despite these challenges, America’s biopharmaceutical companies continue to invest in research to develop new treatments. According to a new report by PhRMA, there are nearly 800 cancer medicines and vaccines either in clinical trials or awaiting review by the Food and Drug Administration. Of these medicines, more than 50 are for the treatment of melanoma, 98 for lung cancer and 47 for brain cancer.
 
“While it may sound counterintuitive, research setbacks are instrumental to furthering efforts to better understand a disease and how to treat it. They are also an indication of the incredible difficulty in developing medicines to treat cancer,” stated John Castellani, PhRMA president and CEO. “These setbacks serve as a reminder that to make progress, we need a public policy framework that supports drug development in combination with promising science so that we can bring important innovations to patients.”
 
Significant advancements in the treatment of diseases like cancer are typically the result of cumulative innovation over time, rather than a single breakthrough in treatment. Every success — and every “failure” — builds on previous advances to improve patients’ lives. Research has shown that cancer is actually a set of more than 200 extremely complex diseases and discovering medicines that effectively treat each one is a difficult task.
 
“While it is incredibly disappointing to see a promising new drug candidate eliminated from the pipeline, researchers take immeasurable learnings from every setback and build upon each one to develop effective therapies for patients,” said Castellani.
 
The release of the “Researching Cancer Medicines: Setbacks and Stepping Stones,” report comes in advance of the Turning the Tide Against Cancer National Conference on Oct. 9. At the meeting, Castellani will join other health care stakeholders to discuss ways to improve cancer care and promote innovation. 

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Dietary supplement industry issues public advisory against marketing around Ebola virus

BY Michael Johnsen

WASHINGTON — The dietary supplement industry on Tuesday spoke out against any supplement manufacturer making advertising claims around the Ebola virus. "The dietary supplement industry is aware of public concern regarding the Ebola virus and of the desire of the public to protect itself against this virus," the industry stated in a joint statement of five associations. "We are unaware of any scientific data supporting the use of dietary supplements to prevent Ebola virus infection or treat Ebola virus disease. Furthermore, federal law does not allow dietary supplements to claim to treat any diseases, including Ebola virus disease."

The American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, the Natural Products Association and the United Natural Products Alliance endorsed the following unified advisory for marketers and retailers, as well as for consumers of dietary supplements:
 
  • Marketers and retailers of dietary supplements are urged to refuse to stock or sell any supplements that are presented as treating or curing Ebola virus disease, or preventing Ebola virus infection;
  • Marketers and retailers should refrain from promoting any dietary supplement as a cure or treatment for Ebola virus disease;
  • Anyone who believes they may have Ebola virus disease or may have come in contact with the Ebola virus should contact a healthcare professional immediately. The Centers for Disease Control and Prevention has more information on Ebola virus disease and the proper actions to take if you suspect you are ill; and
  • While there are many dietary supplements that have much to offer in terms of enhancing general immune function, therapies for the treatment of Ebola virus disease should only be recommended by qualified healthcare professionals or public health authorities.
The organizations supporting this advisory represent the majority of dietary supplement manufacturers. Each of the associations and its member companies remain committed to providing the American public with high-quality products for supporting personal health and permitting “self-care” choices. Each of the associations is also committed to recognizing that self-care is discouraged for some health conditions. The current outbreak of Ebola virus disease is such a condition.
 

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CRN reaches 41-year high of 151 member companies

BY Michael Johnsen

WASHINTON — The Council for Responsible Nutrition on Tuesday announced that, with the addition of three new companies, its membership roster is at a 41-year high of 151 member companies. The three new companies include BioCell Technology, DianaPlantSciences and Proliant Health.
 
“CRN continues to attract companies who might not have previously thought of joining us, but see the immense value that results from collaborating with colleagues and competitors who share a common value—doing what’s right for their consumers with safe and beneficial products," said Steve Mister, CRN president and CEO. "In fact, over the past five years, thanks to companies who are committed to the long-term growth of this industry, our dues revenue has increased by 50%, placing us for the first time in the ‘$5+ million’ category of associations. This budget enables us to increase our meaningful work on behalf of our members and be a stronger, unified voice of the industry. Responsible companies want to be part of that.”  
    
BioCell Technology engages in researching, developing, branding, and distributing science-based raw material ingredients that have applications in health and beauty. DianaPlantSciences is in the natural and functional food solutions space, specializing in the commercialization of phyto-actives sustainably sourced from plant cell culture for nutrition. And Proliant Health manufacturers pharmaceuticals-inspired bovine plasma fractions along with cutting edge chicken and beef proteins. Proliant’s proteins are used in everything from vaccines and medical diagnostic kits to providing the performance nutrition elite athletes need to excel.
 
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