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Tuesday, June 5, 2018

Don’t Expect Much from YouTube Vids Labeled for Colon Cancer


One-quarter of 40 YouTube videos ostensibly about colorectal cancer featured “content of minimal or no relevance to colorectal cancer or screening,” according to a study presented here.
Among them: the most popular video that turned up on the site with a search for “colon cancer,” with some 3 million views.
“That was what was striking,” lead author Donelle Cummings, MD, of SUNY Downstate Medical Center in Brooklyn, N.Y., told MedPage Today. Cummings and colleague Prameela Rao, MD, presented their findings at Digestive Disease Week.
The pair searched YouTube for the terms “colon cancer” and “colon cancer screening” over 3 weeks last year, evaluating the top 20 most-viewed videos’ content and associations for both terms.
They did not find much educational content in videos with the most views, Cummings said.
“Providers must become familiar with web-based content and patients’ use of it for gathering information about colorectal cancer screening,” Cummings and Rao wrote in their poster. “Stakeholders must develop novel methods to educate and engage individuals using YouTube and similar platforms” to increase knowledge and screening rates.
About one-quarter of the videos included “expert or professional testimonial or narration,” the authors reported. Nearly half included information on colorectal cancer pathology, screening methods, and the benefits of screening. About one-quarter discussed risk factors, while 14 discussed signs and symptoms, and 14 treatments. Six discussed screening risks.
Two videos were actually advertisements.
Concerning the most-viewed video, Cummings noted it featured video of an endoscopy with limited dialogue — and nothing about colorectal cancer or screening.
Among the 40 videos, 16 were user-generated or independent. Cummings and Rao found seven posted by non-profits or public healthcare organizations, and five from national or international societies.
YouTube is second among all websites in total views, the authors noted, and “promotional messages have been shown to increase” screening rates. They added, “As individuals increasingly rely on web-based media to gather information, they may have difficulty finding quality content.”
So “it’s very important” for providers to be aware of what content is on popular sites, Cummings said, noting that educating patients is part of the job. “We have to kind of adapt with the times,” he added. Cummings advised providers look for quality online resources and steer patients to those, particularly any hosted by academic institutions and national societies.
Cummings encouraged stakeholders to work with YouTube to produce more certified videos on the site. The site has already begun displaying more certified videos recently “with high-quality content,” he said. “I’m encouraged by what I’ve seen lately.”
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Osteoporosis Risk After Bariatric Surgery


Anatomical changes due to bariatric surgery can put patients at risk for mineral deficiencies and subsequent osteoporosis, and managing this risk can pose a challenge for healthcare providers.
“Many forms of bariatric surgery lead to malabsorption of calcium and vitamin D, which can cause secondary hyperparathyroidism in the absence of treatment,” Elaine W. Yu, MD, of Massachusetts General Hospital in Boston, explained to MedPage Today.
However, the degree of fracture risk following bariatric surgery varies based on the specific procedure.
“Mixed restrictive and malabsorptive procedures such as Roux-en-Y gastric bypass (RYGB) and biliopancreatic diversion (BPD) are associated with an increased risk of fracture at osteoporotic sites, risk that starts to manifest between 2 and 5 years after surgery,” Anne Schafer, MD, of the University of California San Francisco and the San Francisco VA Healthcare System told MedPage Today. “Laparoscopic adjustable gastric banding (LAGB) appears not to increase fracture risk, at least in the short term, and it is not possible at this point to determine whether sleeve gastrectomy increases fracture risk.”
While sleeve gastrectomy may also cause bone loss, it’s perhaps to a lesser degree than BPD or RYGB, Yu said.
Schafer said that “the literature is largest and strongest for RYGB” mostly because it was the reigning bariatric procedure in popularity until recently.
“After RYGB, bone mineral density declines at the axial and appendicular skeleton, and there are detrimental effects on bone microstructure and estimated strength. Postmenopausal women seem to be particularly affected,” she noted.
As for screening, the joint guidelines released by the American Association of Clinical Endocrinologists (AACE), the Obesity Society, and American Society for Metabolic and Bariatric Surgery (ASMBS) state that DXA bone density scans are indicated both preoperatively and 2 years after bariatric surgery.
“In particular, I recommend screening patients who are at higher risk for low bone density, such as postmenopausal women, older men, and those with prior fragility fractures or a family history of osteoporosis,” Yu said.
This recommendation was echoed by Schafer, who added, “I believe DXA may be appropriate preoperatively in higher-risk patients, including postmenopausal women, men ages >50 years, and others with risk factors for osteoporosis. It could also be considered postoperatively, perhaps after 2 years, in select patients.”
In addition to screening bariatric surgery patients for bone changes, clinicians must also closely monitor calcium and vitamin D levels before and after surgery.
“Especially considering that patients with obesity are at high risk of vitamin D deficiency, one should measure serum 25-hydroxyvitamin D (25OHD) level and correct vitamin D deficiency preoperatively. Postoperatively, routine monitoring of serum 25OHD, calcium, albumin, and parathyroid hormone (PTH) levels is indicated. The recommended frequency of these measurements varies between guidelines, but one reasonable approach is to do routine biochemical screening every 6 months for the first 2 years and then annually,” Schafer said.
She recommended that providers refer to the guidelines of the ASMBS when considering calcium and vitamin D supplementation for these patients.
“Calcium citrate is preferred over calcium carbonate,” Schafer said, adding that it should be administered with split doses to achieve a total daily calcium intake — including diet plus supplements — of 1,200 to 1,500 mg per day in patients who underwent RYGB, sleeve gastrectomy, or LAGB. Patients who underwent BPD should aim to achieve a total intake of 1,800 to 2,400 mg daily, she added.
“These intakes may not be sufficient for a substantial proportion of patients, at least after RYGB and BPD, and thus monitoring with PTH (and 24-hour urinary calcium when appropriate) is important,” Schafer noted.
She also suggested that “a typical initial vitamin D supplement dose is 3,000 IU of vitamin D3 daily, with titration to serum 25OHD >30 ng/mL.”
Lifestyle modification after bariatric surgery is important for these patients in order to mitigate the adverse impact on their bones. Other recommendations include a diet sufficient in protein and regular physical activity.
In some bariatric surgery patients at a moderate to high fracture risk, antiresorptive osteoporosis therapies may also be appropriate. However, in order to minimize the risk of hypocalcemia, “an antiresorptive should be used only after vitamin D and calcium supplementation is deemed sufficient based on measurement of serum 25OHD, corrected calcium, PTH, and potentially 24h urinary calcium,” Schafer said, explaining that the parenteral route is preferred over oral treatment.
This recommendation was reinforced by Yu, who suggested that providers “avoid oral bisphosphonates due to theoretical problems with absorption and potential for increased risk of GI adverse effects. Intravenous bisphosphonates and/or denosumab could be cautiously considered as long as providers ensure appropriate calcium and vitamin D supplementation to avoid hypocalcemia.”
She also said that healthcare providers must emphasize to patients prior to bariatric surgery that calcium and vitamin D supplements are “lifelong requirements” following surgery.
“I want to reiterate the call for bone density screening in this population — in an analysis that we published, only around 10% of bariatric patients received bone density scans at any point after surgery,” Yu noted.
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#ASCO18: Cancer therapy targeted at tumor genetics doubles survival


Using molecular tumor markers to select targeted therapy slowed cancer growth and doubled survival, according to a retrospective analysis of early experience with precision medicine.
Among 1,300 patients with at least one identified genetic alteration, those treated with a drug that targets the alteration had a 3-year overall survival (OS) of 15% as compared with 7% for patients who received nonmatched therapy. At 10 years, 6% of the patients treated with targeted therapy were still alive versus 1% of those who received conventional therapy, reported Apostolia-Maria Tsimberidou, MD, PhD, of the MD Anderson Cancer Center in Houston.
Progression-free survival, objective response rate, and clinical benefit rate all favored targeted therapy, she reported at the American Society of Clinical Oncology (ASCO) meeting.
“This is the first and largest study — with the longest follow-up — to assess the impact of precision medicine on survival across multiple cancer types,” she said during an ASCO press briefing. “Our findings show that molecular testing of tumors using next-generation sequencing can be used to optimize therapy and should be taken into consideration when selecting therapy for patients with difficult-t0-treat cancers.”
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Apostolia-Maria Tsimberidou, MD, PhD, presenting the results
Noting that the results represented experience with patients treated as long ago as 2007, Tsimberidou said, “I am optimistic that in the next few years, we will dramatically improve outcomes for patients with cancer by increasing implementation of precision medicine.”
The advent of precision medicine transformed traditional paradigms for treating cancer, which focused on the type of cancer, growth kinetics, and other less specific methods of matching therapy to disease, said ASCO expert Catherine Diefenbach, MD, of NYU Langone Medical Center in New York City.
“This method of molecular profiling tumors and treating on the basis of actionable mutations is the wave of the future,” said Diefenbach. “Large-scale [studies] will bring these efforts to many, many more patients and will usher in new approaches to treating advanced cancer and hopefully improve overall survival.”
Tsimberidou reported long-term follow-up data from the Initiative for Molecular Profiling in Advanced Cancer Therapy (IMPACT). Begun in 2007, the study had a working hypothesis that selecting cancer therapy on the basis of patient’s tumor molecular analysis would lead to better outcomes as compared with the prevailing standard approaches.
The study involved patients with advanced-stage cancers for which no standard treatment options existed or who had incurable rare cancers. Study participants had been referred for molecular testing of tumor specimens, which might have involved a single gene during early stages of the testing program to as many as 50 in the later years.
If the test results showed an actionable mutation, patients were matched with targeted therapies, if available. If no appropriate targeted agents were available, patients received nonmatched treatment.
From 2007 to 2013, 3,743 patients underwent molecular testing, which revealed at least one targeted alteration in 1,307 patients. Subsequently, 711 of the patients were matched to a targeted therapy, and 596 received nonmatched therapy. The patients had received a median of four prior regimens, and 2.8% of the cohort had no prior treatment before referral for molecular evaluation. The most common types of cancer represented by the cohort were gastrointestinal (24.2%), gynecologic (19.4%), breast (13.5%), melanoma (11.9%), and lung (8.7%).
Tsimberidou reported that matched therapy resulted in an objective response rate of 16.2% versus 5.2% for nonmatched treatment. Additionally, 18.4% of matched patients and 14.7% of unmatched patients had stable disease for at least 6 months. Matched patients had a significantly higher clinical benefit rate (response plus stable disease: 34.9% versus 20.1%, P<0.001).
Patients who were matched to therapy had a median PFS of 4.0 months and median OS of 9.3 months, as compared with 2.8 and 7.3 months, respectively, for the unmatched population (HR 0.67, HR 0.72, P<0.001). By multivariate analysis, receiving nonmatched therapy was an independent predictor of worse survival (HR 1.30, 95% CI 1.16 to 1.46, P<0.001). Alterations in the PI3K/AKT/mTORpathway also were associated with worse survival (HR 1.25, 95% CI 1.10 to 1.42, P<0.001).
Investigation of the IMPACT strategy will continue in IMPACT 2, an ongoing prospective, phase II randomized trial comparing PFS in patients who received targeted therapy matched to tumor molecular characteristics versus treatment versus nonmatched therapy.
Although IMPACT and other studies have demonstrated the potential benefits of precision medicine and analysis of tumor genetics, the oncology community still has a lot to learn, cautioned Richard Schilsky, MD, ASCO chief medical officer.
“There’s a lot of this going on in routine clinical practice these days, and that’s probably a leap a little too far ahead of what the data will support, at least in the context of patients with far-advanced cancer,” he said. “Doing this in the context of a research program is a completely valid and important thing to do until we get the information we need about the circumstances under which these approaches actually work.”
Otis Brawley, MD, American Cancer Society chief medical officer, offered a more succinct cautionary assessment. “Precision medicine has given us some things, but it has promised a lot — which it has yet to deliver,” he said.
Tsimberidou disclosed relevant relationships with Baxter, Bayer, Boston Biomedical, EMD Serono, Foundation Medicine, IMMATICS, Karus Therapeutics, ONYX, Placon, and Stem Cells Inc. Co-authors disclosed multiple relevant relationships with industry.
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2 Allergan holders call for split of chairman-CEO post


Two of Allergan Plc’s (AGN.N) shareholders – hedge funds Appaloosa Management and Senator Investment Group – on Tuesday asked the drugmaker’s board to split the role of chief executive officer and chairman, and end its acquisition strategy.
Allergan, which has a market value of about $51 billion, is saddled with a long-term debt of $26.6 billion as of March end – an outcome of a string of acquisitions.
The company’s shares have fallen about 33 percent in the past 12 months, up to Allergan’s close on Monday. The stock was up nearly 2 percent at $154.22 in late morning trading on Tuesday.
“It is time for Allergan’s management to concentrate on running a world class pharmaceutical and aesthetics business and forego thoughts of, or the exhilaration from, an ambitious acquisition strategy,” the shareholders said in a letter.
Allergan did not immediately respond to request for comment.
Earlier this year, the Dublin-based company under CEO Brent Saunders took up a strategic review and last week decided to sell its smaller businesses, the women’s health and infectious disease units.
However, some investors had hoped for a more dramatic outcome from the company’s strategic review.
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“Like the rest of the investment community, we were underwhelmed by the Company’s half-hearted attempt to restore strategic momentum,” Tepper, along with Douglas Silverman, Managing Partner for Senator Investment Group, said in a letter.
The two hedge funds said after splitting the position of chairman-CEO, the company should hire a new person for one of the posts from outside the company.
The shareholders, who have a combined stake of nearly 2 percent, said they had previously sent similar letters to the drugmaker’s board in May and April.
In May, Appaloosa and two of billionaire investor David Tepper’s funds received Federal Trade Commission clearance for the billionaire to become an activist investor in Allergan.
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Co-Diagnostics details advances in genotyping tech


 Co-Diagnostics, Inc. (NASDAQ: CODX) (“Co-Diagnostics” or the “Company”), a molecular diagnostics company with a unique, proprietary platform for the development of diagnostic tests, announced today an advancement in the Company’s Co-Primer™ platform technology in multiplex tests for SNP detection, which allows for multiple targets to be identified in a single reaction without costly and time-consuming re-optimization of primers.
SNP detection refers to finding small-scale but clinically-significant mutations in a given gene using real-time polymerase chain reaction (PCR) testing. Medical applications of SNP detection include identifying the presence of cancer cells or cell-free genetic material in a liquid or tissue biopsy, and to determine the distinct type of cancer involved. A real-life example of this includes being able to identify specific mutation(s) in genes linked to breast cancer in order to determine a patient’s prognosis, initiate the most effective and affordable treatment and to determine whether chemotherapy is necessary. SNP detection is also used in the agricultural industry to identify variations in crop genomes associated with desired characteristics such as higher yield, drought and disease resistance and improved seed viability.
Multiplexing is the ability to identify several different DNA sequences (or loci) simultaneously in a single PCR test procedure, as opposed to conducting several individual procedures. As multiple SNP targets are added to a multiplexed reaction, the individual primer pair molecules used in standard PCR reactions must be designed, optimized and verified independently to ensure they do not cross-react and affect the outcome (i.e. generate a false positive result). The recently completed study confirms the ability of CoPrimers to be used in multiplexed SNP reactions without subsequent re-optimization, allowing researchers or technicians to utilize any combination of primer sets without concerns of cross-reactivity.
Co-Diagnostics CEO Dwight Egan commented: “The unique structure and cooperative relationship between the Co-Primer molecules enhance PCR by making the reactions more specific, to better differentiate between similar target genetic sequences. The medical and diagnostics industries are more aware than ever of the importance of correctly and accurately identifying the existence and genetic variant of cancer in patients afflicted by this life-altering condition. The Company’s development will further augment our product offerings, where specificity is the key to unlocking successful multiplexed reactions. Industry experts have already recognized the advantages of Co-Primers in being able to “mix-and-match” primers for SNP mutations and we are confident that the potential applications of our advanced technology represents a key opportunity for the Company, and for PCR technology as a whole.”
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Hookipa, Gilead in pact for HIV, hep B immunotherapies


 Hookipa Biotech AG (“Hookipa”), a clinical-stage biotech company pioneering an innovative class of active immunization therapies for oncology and infectious diseases and Gilead Sciences, Inc., (“Gilead”), a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need, today announced that they have entered into a research collaboration and license agreement that grants Gilead exclusive rights to Hookipa’s TheraT®and Vaxwave® arenavirus vector-based immunization technologies for two major chronic infectious disease indications, hepatitis B virus (HBV) and human immunodeficiency virus (HIV).
Under the terms of the agreement, Gilead will provide an upfront payment of $10 million. Additionally, Hookipa will be eligible to receive milestone payments based upon the achievement of specified development, regulatory, and commercial milestones up to a total of more than $400 million. Gilead will fund all research and development activities. Hookipa will also be eligible to receive tiered royalties on net sales.
“Gilead, a world leader in innovative therapies against major viral diseases, is the ideal partner for us to drive our pipeline development in this area for the benefit of patients in need. This partnership is strong recognition of our unique immunization technology, and helps us concentrate our own energy and resources on immuno-oncology,” commented Joern Aldag, Chief Executive Officer of Hookipa. “The collaborative HIV and HBV programs nicely complement our significant efforts in the infectious disease area with an exciting proprietary prophylactic CMV vaccine.”
“Gilead is committed to advancing innovative approaches directed at functional cures against HIV and HBV,” said Bill Lee, PhD, Executive Vice President of Research, Gilead. “We are convinced that Hookipa’s unique therapeutic vaccine technology, which has demonstrated excellent safety and immunogenicity in Phase 1 clinical studies, has strong potential to have synergistic effect with other Gilead cure efforts in both of these diseases areas. Our ultimate long-term goal is to eliminate the need for life-long antiviral therapy for millions of patients around the world.”
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AbbVie rheumatoid arthritis med meets endpoints in Phase 3 study


AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive top-line results from SELECT-EARLY showing that both doses of upadacitinib monotherapy (15 mg and 30 mg) met the primary endpoints of ACR50a at week 12 and clinical remissionb at week 24 versus methotrexate (MTX).1 Additionally, all ranked secondary endpoints were met.1 The ongoing study evaluates upadacitinib, an investigational oral JAK1-selective inhibitor, as a monotherapy treatment compared to methotrexate monotherapy in adult patients with moderate to severe rheumatoid arthritis who were methotrexate-naïve.1 Upadacitinib is not approved by regulatory authorities and its safety and efficacy have not been established.
“SELECT-EARLY is the fifth pivotal trial that will support regulatory submissions for upadacitinib in rheumatoid arthritis later this year,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “Results from SELECT-EARLY further support our belief that upadacitinib has the potential to be an important new treatment option for patients with rheumatoid arthritis.”
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