uniQure announced that six data presentations, of which three are oral presentations, will be delivered at the upcoming American Society of Gene and Cell Therapy 21st Annual Meeting held in Washington D.C., April 29 – May 2, 2019. “We have made significant progress over the past year in advancing our gene therapy expertise through expansion of our research pipeline,” stated Sander van Deventer, M.D., Ph.D., chief scientific officer at uniQure. “We are very pleased to have such a strong showing at ASGCT, and to have new preclinical data featured in Huntington’s disease, hemophilia A and Fabry disease. We look forward to having these data prominently featured at the conference.”
https://thefly.com/landingPageNews.php?id=2892693
Monday, April 15, 2019
Don’t Cave: Physician-Assisted Suicide Unethical
Physician-assisted suicide and euthanasia (PAS-E) has been a source of discussion for millennia, as evidenced by its explicit mention in the Hippocratic Oath from the fifth to third century B.C., where Hippocrates includes it among the list of things physicians must never participate in. In the aftermath of the horrors of the 20th century, where thousands of people were euthanized without their consent in World War II, there was an even stronger swing of the pendulum against any form of PAS-E.
However, the latter half of the 20th century has seen a resurgence of this debate, with a number of countries, including Belgium, the Netherlands, Canada, and Luxemburg, having legalized euthanasia, with a push to normalize PAS-E worldwide. This month, the World Medical Association (WMA), the international organization representing physicians to ensure their independence and work towards the highest standard of ethical behaviorand care, will hold its 212th Council Session, where it has called for written opinions re-examining the PAS-E statement in the WMA code of ethics.
Currently, the language in the code of ethics on PAS-E, adopted by the 53rd WMA General Assembly in 2002, states that “[PAS], like euthanasia, is unethical and must be condemned by the medical profession. Where the assistance of the physician is intentionally and deliberately directed at enabling an individual to end his or her own life, the physician acts unethically.” The statement even encourages national medical associations and physicians to refrain from participating in euthanasia, even if national laws allow it.
At the WMA medical ethics conference in October 2018, a proposal was submitted by the Canadian Medical Association (CMA) and Royal Dutch Medical Association (KNMG) to amend the WMA ethics code on PAS-E from condemning the practice to neutrality. This proposal was strongly opposed and was retracted.
Rather than make their controversial case before the conference, the Canadian and Dutch parties turned a minor scandal into a reason to leave the WMA altogether. The inaugural speech contained passages that had been plagiarized by a speechwriter; despite the WMA President’s public apology, saying he was not aware of this, the CMA, without consulting with its wider membership, withdrew from the WMA, citing unethical conduct, and the KNMG also later withdrew, citing the same reasons.
The WMA called for written opinions re-examining the PAS-E statement in its code of ethics for the general session in April 2019. The German Medical Association has suggested a compromise to reword parts of the code such as “physician-assisted suicide” to “physician-assisted death” and “unethical and must be condemned” to “physicians should not engage.” Other national associations of the WMA had also overwhelmingly opposed this proposal.
With two major national associations having left the WMA, there will now be pressure on the WMA to come up with a compromise to woo them back.
However, the WMA should not respond to such bullying tactics. It sets a poor precedent for proposals from other countries, which would allow for similar responses in the future. It also introduces inequality in influence, with only two countries having disproportionate ability to influence WMA policy, whether considered ethical or not by the rest of the WMA.
The WMA should not consider the German proposal. Softened wording neuters the gravity of PAS-E by taking it out of the sphere of medical ethics, and such a change would also clearly signal having caved to the demands of the CMA and KNMG, encouraging these groups to press for further change. Furthermore, the WMA has a policy that physicians should not take part in unethical practices, even if they are legal. The German proposal would exclude PAS-E from that policy.
Most importantly, in a pluralistic society, the purpose of forums such as the WMA is to create a setting for debate and discourse. Whether one thinks that PAS-E is ethical or not, it is important for national medical associations to continue the process of engaging with colleagues, and convince or be convinced by them through debate rather than exiting the dialogue altogether.
John Y. Rhee, MD, MPH is an intern in the Department of Medicine at Mount Sinai Hospital in New York City and a resident in the Department of Neurology at Massachusetts General Hospital/Brigham and Women’s Hospital at Harvard Medical School in Boston.
Amicus to present first preclinical results for Pompe gene therapy at ASGCT
Amicus Therapeutics announced the company will present initial preclinical data from its investigational adeno-associated viral gene therapy program for Pompe disease in a poster at the American Society of Gene & Cell Therapy, or ASGCT, 22nd Annual Meeting on April 30. “These represent the first set of preclinical results for the Pompe gene therapy which Amicus is currently developing in collaboration with the Gene Therapy Program of the Perelman School of Medicine at the University of Pennsylvania,” the company noted.
https://thefly.com/landingPageNews.php?id=2892685
https://thefly.com/landingPageNews.php?id=2892685
Primary care < 5% of Medicare spend
Primary care spending as a percentage of total spending in the Medicare program is low, according to a RAND study.
KEY TAKEAWAYS
Primary care services have long been defined by “higher quality, better outcomes and lower costs,” according to the RAND study.
For narrow definitions of primary care, the lowest percentage of spending came from North Dakota at 1.59% while Hawaii led the way with 3.19%.
For expansive definitions, the lowest percentage came from the District of Columbia at 2.92% while Iowa led the nation at 4.74%.
Primary care services make up a small percentage of spending by Medicare beneficiaries, ranging between just over 2% to nearly 5%, according to a new RAND study released Monday.
The study analyzed spending by 16 million Medicare beneficiaries with fee-for-service coverage under Parts A and B, along with Part D prescription coverage, during 2015.
Narrow primary care spending by beneficiary under the narrow definition totalled $308.32, while services rendered under the broad definition reached $387.79. For all professional services under the narrow definition, beneficiaries spent $550.62 while the amount spent under the broad definition totalled $708.23.
Primary care services have long been defined by “higher quality, better outcomes and lower costs,” according to the report, though fluctuations between the percentage that primary care spending represents depend on whether narrow or expansive definitions are applied.
RAND researchers stress the study’s findings provide a set of reference points that could be beneficial for hospital administrators looking to benchmark while also contributing to “policy debates about investment in primary care.”
Mark W. Friedberg, one of the study’s authors, told HealthLeaders that health system CFOs would also benefit from reviewing the Millbank Memorial Fund report released last October to understand the technical aspects of how primary care spending can be measured within a health system using claims data.
“There are multiple ways of defining primary care, both based on provider training background and the type of service they’re providing,” Friedberg said. “Depending on how you set the dials on those assumptions, you could get different Medicare spending figures. Of course none of them are high, in the Medicare population, you’re dealing with primary care spending under 5% of total spending, no matter how you set the dials.”
Friedberg added that another interesting finding from the report is primary care spending represents a lower fraction of total spending as patients get older. While older cohorts spend more on primary care, they also spend much more on treatment from specialists to monitor more serious or chronic medical conditions.
When reviewing the data, it’s clear that primary care spending varies geographically.
For narrow definitions of primary care, the lowest percentage of spending came from North Dakota at 1.59% while Hawaii led the way with 3.19%. For expansive definitions, the lowest percentage came from the District of Columbia at 2.92% while Iowa led the nation at 4.74%.
Friedberg said that the upper Midwest recorded low primary care spending, using a narrow definition of services, but was not low when the broader definition was applied. He said this means the providers in those states are mostly conducting comprehensive care, including a combination of other services beyond the definition of primary care.
Since primary care spending in the Medicare program low, Friedberg recommends investing in primary care to provide them with additional capabilities.
“Maybe you want to give [primary care providers] another 10% or 20% on top of their current budgets for taking care of their patient populations,” Friedberg said. “T hat’s not going to break the bank because the denominator for primary care is so low. You’re talking about adding less than half a percent to total Medicare spend if you do something like that.”
Cannabis stocks led down by Aphria as quarterly loss outweighs revenue surge
Cannabis stocks were mostly lower Monday, led down by Aphria Inc. after it swung to a wide loss in the third quarter that outweighed a surge in revenue.
Aphria shares APHA, -12.82% APHA, -11.71% fell 15% in early trade, after the Leamington, Ontario-based company posted a C$108.2 million ($81.1 million) for its fiscal third quarter, or 43 cents a share, after a profit of C$12.9 million, or 8 cents a share, in the same period a year ago.
Excluding nonrecurring items, such as noncash impairments and additional nonoperating losses, adjusted gross profit was C$13.4 million. FactSet does not provide consensus estimates for Aphria.
Revenue climbed to C$73.6 million from C$10.3 million in the first full quarter of Canadian legal cannabis. But the company sold less cannabis than a year ago—kilograms sold fell to 2,636.5 from 3,408.9, while the average retail selling price for medical cannabis increased to C$8.03 per gram from C$7.51, primarily because of higher oil sales. The average price for adult-use cannabis fell to C$5.14 from C$6.32, due to a shift to smaller package sizes.
Separately, the company said it has entered into a series of deal to accelerate the expiry date of the unsolicited offer launched by Green Growth Brands Inc.GGBXF, -0.12%
Organigram Holdings Inc. shares OGRMF, -4.87% fell 7.1%. Like Aphria and other rivals, Organigram posted a loss for its fiscal second quarter, while revenue topped estimates. The company reported a net loss of C$6.4 million ($4.8 million), or 5 cents a share, after earnings of C$1.076 million, or 1 cent a share, in the year-earlier period.
Net revenue (excluding excise taxes) came to C$26.9 million. The consensus of four analysts polled by FactSet was for EPS of 2 cents and revenue of C$24.2 million.
The company said its “all-in” cost of cultivation came to 85 cents per gram of dried flower harvested, down from C$1.48 a year ago, mostly due to higher yields per plant. It is now focusing on vaporizable pen technologies and a range of edibles ahead of the launch of derivatives in Canada in the fall of 2019.
U.S. cannabis retailer MedMen Enterprises Inc. MMNFF, +1.80% offered unaudited revenue numbers for its fiscal third quarter to end March of $36.6 million, up 22% over the second quarter. The growth was driven by the company’s retail expansion in Nevada and Arizona, where sales rose 34% and 513% respectively, from the second quarter.
In Nevada, the company’s Paradise location, which is closest to McCarran Airport, is the company’s second highest performer, with a 39% increase on the second quarter.
The company said pro forma revenue, including for acquisitions that have not yet closed, came to $54.9 million, up 11% from the second quarter. The company announced plans to acquire PharmaCann LLC in October, in an all-stock deal valued at $682 million.
In regulatory news, the U.S. Hemp Authority is revising guidelines for CBD producers seeking a seal that ensures the safety of their products and has set an April 15 deadline for manufacturers to comment on how the industry should self-regulate, Marijuana Business Daily reported.
The U.S. Food and Drug Administration has separately pledged to hold a public hearing on May 31 for stakeholders to share their experiences, and offer information and views on how the CBD market should be regulated. While hemp was fully legalized in the December Farm Bill, CBD was moved under the purview of the FDA from the DEA, and the former has said companies cannot add it to food or beverages without its approval.
Meanwhile, investors are bracing for the initial public offering later this week of what will be the closest thing to a U.S. cannabis company available for trade on a major U.S. exchange. Greenlane Holdings Inc. GNLN, +0.00% a Florida-based maker of cannabis vape hardware and accessories to retail businesses and consumers across the U.S., Canada and elsewhere around the world, is expected to price its IPO on Wednesday and to start trading Thursday on Nasdaq, under the ticker symbol “GNLN.”
Elsewhere in the sector, Canopy Growth Corp. CGC, -3.88% WEED, -3.37% was down 3.8%, Aurora Cannabis Inc. ACB, -3.49% ACB, -3.13% was down 3.1% and Cronos Group Inc. CRON, -7.22% CRON, -5.82% was down 5.2%.
Tilray Inc. TLRY, -5.97% was down 4.4%, Cresco Labs CRLBF, -4.02% was down 2.6%. Hexo Corp. was down 3.8% and Green Organic Dutchman Holdings Ltd.TGODF, -5.77% TGOD, -5.48% was down 5.8%. Aleafia Health Inc. f ALEF, -7.74%ALEF, -7.74% ell 7.9%, CannTrust Holdings Inc. CTST, -5.30% TRST, -5.14% was down 5.2% and GW Pharmaceuticals PLC GWPH, -2.40% was down 1.1%.
FDA added sugar label could be cost-effective way to boost health, savings
The Food and Drug Administration’s (FDA) mandatory added sugar labeling policy for packaged foods and beverages, set to take effect between 2020 and 2021, could be a cost-effective way to generate important health gains and cost-savings for both the healthcare system and society in the U.S., according to a new modeling study led by researchers from the Friedman School of Nutrition Science and Policy at Tufts University and the University of Liverpool. The analysis is the first to estimate the potential health and economic impacts of the new label.
In 2016, the FDA announced several mandatory changes to the Nutrition Facts label in order to provide consumers with enhanced nutritional information. Among the changes was adding the grams and percent Daily Value of added sugar content, which would help consumers limit calories from added sugar in accordance with the recommendations of the 2015-2020 Dietary Guidelines for Americans.
The study, published today in Circulation, estimates that the FDA’s added sugar label could prevent or postpone nearly 1 million cases of cardiometabolic disease, including heart disease, stroke and type 2 diabetes, over a 20-year period. When combined with possible industry reformulations to reduce added sugar content in packaged foods and beverages, the label could prevent or postpone nearly 3 million cases of cardiovascular disease and diabetes over the same time period. Cost-effectiveness of each scenario was evaluated from a healthcare perspective (accounting for policy costs and medical costs) and from a societal perspective (further accounting for informal care costs and lost productivity costs). Both scenarios were estimated to be cost-effective within five years and cost-saving within seven years.
Specifically, the analysis estimates that the added sugar label could:
- Prevent or postpone 354,400 cases of cardiovascular disease and 599,300 cases of diabetes;
- Gain 727,000 quality-adjusted life-years (QALYs); and
- Save $31 billion in net healthcare costs and $61.9 billion in societal costs. Policy costs were estimated to be $1.7 billion.
Taking into consideration possible reformulation by the food industry, the analysis yielded greater corresponding gains, estimating that the new label could:
- Prevent or postpone 708,800 cases of cardiovascular disease and 1.2 million cases of diabetes;
- Gain 1.3 million QALYs; and
- Save $57.6 billion in net healthcare costs and $113.2 billion in societal costs. Policy costs, including industry reformulation costs, were estimated to be $4.3 billion.
“The added sugar label is an important policy step toward reducing consumption of foods and beverages with high added sugar contents, improving health, and lowering healthcare spending,” said Renata Micha, R.D., Ph.D., the study’s co-senior and corresponding author and research associate professor at the Friedman School of Nutrition Science and Policy at Tufts University. “These findings have important implications for individuals, policy makers and the food industry alike. Modest industry reformulation would be a powerful way to maximize potential benefits, highlighting industry’s critical role in being part of the solution.”
While some companies have begun listing added sugar content, the 2018 deadline for compliance has been extended to 2020 for large manufacturers and 2021 for small manufacturers.
“Informing consumers about what is in their sugary drinks, cakes, and sweets will help them decide what they want to eat for their health now and later,” said Martin O’Flaherty, M.D., Ph.D., co-senior author and professor in epidemiology at the University of Liverpool. “Full implementation of the label before 2021 could help maximize health and economic gains.”
The researchers note that Americans consume more than 15 percent of their total calories from added sugars and overconsumption of added sugars is linked to an increased risk of cardiometabolic diseases. These diseases pose large health and economic burdens for the society and the healthcare system. Food labeling could be an effective strategy to support informed consumer choice and reduce added sugar intake, while further stimulating industry reformulation, as supported by recent experience with trans fat labeling in the U.S.
The researchers used a validated microsimulation model (IMPACT) to estimate the potential health impact, costs, and cost-effectiveness of the FDA’s added sugar label based on the two scenarios, which were compared with a “no intervention” baseline scenario over a 20-year timeframe (2018-2037). The model generated a sample representative of the U.S. adult population and utilized data from the two most recent National Health and Nutrition Examination Survey cycles (2011-2014), CDC Wonder, meta-analyses, and other validated sources.
The model evaluated health benefits and cost-savings from cardiometabolic health outcomes; increased healthcare costs from competing diseases could reduce cost-effectiveness, while other health benefits would further contribute to health gains and cost-savings.
Story Source:
Materials provided by Tufts University, Health Sciences Campus. Note: Content may be edited for style and length.
Journal Reference:
- Yue Huang, Chris Kypridemos, Junxiu Liu, Yujin Lee, Jonathan Pearson-Stuttard, Brendan Collins, Piotr Bandosz, Simon Capewell, Laurie Whitsel, Parke Wilde, Dariush Mozaffarian, Martin O’Flaherty, Renata Micha. Cost-Effectiveness of the US Food and Drug Administration Added Sugar Labeling Policy for Improving Diet and Health. Circulation, 2019; DOI: 10.1161/CIRCULATIONAHA.118.036751
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