{"id":3546,"date":"2013-01-01T19:47:09","date_gmt":"2013-01-01T19:47:09","guid":{"rendered":"https:\/\/www.pm360online.com\/?p=3546"},"modified":"2014-01-12T13:16:35","modified_gmt":"2014-01-12T13:16:35","slug":"the-cancer-breath-test-ban-on-off-label-marketing-overturned","status":"publish","type":"post","link":"https:\/\/www.pm360online.com\/the-cancer-breath-test-ban-on-off-label-marketing-overturned\/","title":{"rendered":"The Cancer Breath Test; Ban on Off-label Marketing Overturned?"},"content":{"rendered":"

The Cancer Breath Test<\/strong><\/p>\n

Screenings for cancer are uncomfortable enough to begin with\u2014based solely on the fact that you are testing to see if you have cancer\u2014so the fact that the test for colorectal cancer involves a colonoscopy (and tubes going where you prefer they don\u2019t go) only makes the screening that much more uncomfortable and far less appealing. However, researchers may have found a way that eliminates all of that, and all the patient has to do: exhale.<\/p>\n

Donato F. Altomare, MD, of the Department of Emergency and Organ Transplantation at the University Aldo Moro of Bari, and his colleagues collected exhaled breath from 37 patients with colorectal cancer and 41 healthy patients (serving as the control group) and tested the samples to determine their volatile organic compound (VOC) in order to test if a simple breath would be able to reveal cancer. According to the results published in the British Journal of Surgery, the test was able to correctly identify 32 of the 37 patients with cancer, but it also incorrectly diagnosed seven of the 41 healthy patients\u2014overall that gives the test a 76% accuracy rate.<\/p>\n

\u201cThe technique of breath sampling is very easy and non-invasive, although the method is still in the early phase of development,\u201d Altomare said. \u201cOur study\u2019s findings provide further support for the value of breath testing as a screening tool.\u201d<\/p>\n

In the meantime, patients will just have to settle for being a little uncomfortable.<\/p>\n

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DC Dispatch<\/strong><\/p>\n

Ban on Off-label Marketing Overturned?<\/strong><\/p>\n

The First Amendment promises U.S. citizens the right to free speech, and according to the Court of Appeals for the Second Circuit in Manhattan that includes a sales rep\u2019s right to discuss off-label uses of the drugs that he\/she promotes. Under the Food, Drug and Cosmetic Act, the sale of a misbranded drug is illegal, and the pharma industry has paid heavy fines whenever it has been caught doing so\u2014just last month Amgen had to fork over $762 million for the misbranding of its anaemia drug Aranesp. However, the pharma industry may have caught a break when last month the Second Circuit court overturned the ruling in United States v. Caronia, which involved a sales rep who was caught on tape discussing unapproved uses of the narcolepsy drug Xyrem with a doctor who was a government informant, according to The New York Times.<\/p>\n

The court\u2019s 2-to-1 decision ruled that \u201cthe government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.\u201d But this ruling only applies to the Second Circuit (New York, Connecticut and Vermont), and it is likely that the government will appeal, which could bring the case to the Supreme Court. Until then, it is unlikely this decision will have much of an impact on how the industry operates. But Gerald Masoudi, a former chief counsel of the FDA still told The New York Times that \u201cit\u2019s very significant.\u201d<\/p>\n

\u201cIt\u2019s going to make the FDA, in its promotion cases, focus on the kinds of speech that are more likely to harm consumers, such as false or misleading marketing versus something that is not approved,\u201d he said.<\/p>\n

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TeleMed Texts<\/strong><\/p>\n

Survey Says: Internet Saves Lives<\/strong><\/p>\n

The Internet is not all email, social media, funny videos and porn\u2014it turns out that one in 10 Americans believe that without the World Wide Web they would have already died or at the very least be severely incapacitated. A recent U.S. survey of 1,003 adults commissioned by Royal Philips Electronics found that consumers believe that web-based health information, mHealth tools and mobile apps are all keys to living longer lives. In fact, 25% of those surveyed use a symptom checker website or some kind of home-based diagnosis technology as much as they visit the doctor, while another 27% choose to use interactive applications over a trip to the doctor. All of this new technology, however, doesn\u2019t mean people are completely cutting the doctor out of the equation. About half of Americans use symptom checker technologies or home-based vital sign monitors that automatically share information with their doctor.<\/p>\n

\u201cWe are in the early stages of the web-enabled, mHealth, mobile app world of healthcare delivery,\u201d said Dr. Eric Silfen, Chief Medical Officer of Philips Healthcare. \u201cNear-future apps will focus on tying together health information technologies, connecting with doctors, nurses, healthcare professionals and patients, all within a social context that facilitates shared medical decision-making.\u201d<\/p>\n

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Therapeutic Talk: Oncology<\/strong><\/p>\n

Make Way for Targeted Therapies \u00a0<\/strong><\/p>\n

Chemotherapies and hormone therapies have always ruled the prostate cancer market, but a new therapy option may be gaining ground over the next few years. According to the report PharmaPoint: Prostate Cancer\u2014Global Drug Forecast and Market Analysis from GlobalData, the role of chemotherapies will be reduced as targeted therapies like Johnson & Johnson\u2019s Zytiga (abiraterone acetate) and Medivation\/Astellas\u2019 Xtandi (enzalutamide) become the more popular treatment options for metastatic castration-resistant prostate cancer (mCRPC). That\u2019s bad news for the drugs that have historically dominated this market including AstraZeneca\u2019s hormone therapies Zoladex (goserelin acetate) and Casodex (bicalutamide), and Sanofi\u2019s popular chemotherapies Taxotere (docetaxel) and Jevtana (cabazitaxel).<\/p>\n

In fact, GlobalData predicts that Zytiga and Xtandi will dominate the mCRPC space with peak sales of Zytiga reaching $1.7 billion in 2018 and Xtandi sales reaching $2.05 billion by 2022. Another promising drug in the pipeline is Bayer\/Algeta\u2019s Alpharadin (radium-223 chloride), but this drug as well as anything else to emerge from the pipeline over the next decade might have trouble capturing a significant market share. Not only will the market start to become crowded with competitors, but also increasing pressures to prove cost-effectiveness could restrain growth in the prostate cancer market\u2014this is especially true in Europe. Still, with the anticipated success of Zytiga and Xtandi, GlobalData estimates that overall sales of prostate cancer therapeutics will increase from $3.8 billion in 2012 to $7.9 billion by 2022.<\/p>\n

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FDA Update<\/strong><\/p>\n

2012 Matches 2011 in Approvals<\/strong><\/p>\n

The FDA announced that it approved a total of 35 new drugs in the fiscal year 2012, which matches the total from the previous year. This year\u2019s approvals included 10 cancer medicines, Vertex Pharmaceuticals\u2019 cystic fibrosis drug Kalydeco, a meningitis vaccine and the first cord blood product. In terms of the calendar year, however, the agency approved 31 new drugs which tops last year\u2019s seven year high of 30.<\/p>\n

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Faster Med. Device Access<\/strong><\/p>\n

The FDA is joining the first public-private partnership to promote medical device regulatory science with a focus on speeding the development, assessment and review of new medical devices. The new Medical Device Innovation Consortium (MDIC) is an independent, nonprofit corporation, created by LifeScience Alley (LSA), a biomedical science trade association. The MDIC will receive input from industry, government and other nonprofit organizations while prioritizing the regulatory science needs of the medical device community and funding projects to simplify the process of medical device design and the pathway to market.<\/p>\n

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Recent Approvals<\/strong><\/p>\n

ARIAD Pharmaceuticals\u2019 Iclusig (ponatinib) was approved to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases.<\/p>\n

Janssen Biotech\u2019s Zytiga (abiraterone acetate) received an expanded approval to treat men with late-stage (metastatic) castration-resistant prostate cancer prior to receiving chemotherapy. The FDA initially approved Zytiga only for use in patients whose prostate cancer progressed after treatment with chemotherapy.<\/p>\n

Exelixis\u2019 Cometriq (cabozantinib) was approved to treat medullary thyroid cancer that has spread to other parts of the body. It is the second drug approved to treat medullary thyroid cancer in the past two years.<\/p>\n

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The Cancer Breath Test Screenings for cancer are uncomfortable enough to begin with\u2014based solely on the fact that you are …<\/p>\n","protected":false},"author":13,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[336,11990,45,11991,259,114,225,142],"tags":[73833,340,266,53,68,20,44,82],"_links":{"self":[{"href":"https:\/\/www.pm360online.com\/wp-json\/wp\/v2\/posts\/3546"}],"collection":[{"href":"https:\/\/www.pm360online.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pm360online.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pm360online.com\/wp-json\/wp\/v2\/users\/13"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pm360online.com\/wp-json\/wp\/v2\/comments?post=3546"}],"version-history":[{"count":0,"href":"https:\/\/www.pm360online.com\/wp-json\/wp\/v2\/posts\/3546\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.pm360online.com\/wp-json\/wp\/v2\/media?parent=3546"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pm360online.com\/wp-json\/wp\/v2\/categories?post=3546"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pm360online.com\/wp-json\/wp\/v2\/tags?post=3546"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}