TASK DEFINITION: Given a paragraph, generate a claim that is supported by the given paragraph. 1) The claim must contain information from within the paragraph. 2) A sentence within the paragraph can be used as a claim. 3) The claim should not have contradictions within the paragraph. 4) The claim should be at most one sentence long.
PROBLEM: The chamber’s top Republican, who said he was making enactment of the bill “one of my highest priorities,” issued his proposal at a time when the use of e-cigarettes is growing and underage vaping has soared, raising concerns by health expert s. The measure would apply to all tobacco products, e-cigarettes and vapor products and was co-sponsored by Sen. Tim Kaine, D-Va., whose state has also been a major tobacco producer. “Kentucky farmers don’t want their children to get hooked on tobacco products while they’re in middle school or high school any more than any parents anywhere want that to happen,” McConnell said on the Senate floor. Fourteen states, including Arkansas, California and Virginia, have enacted laws raising the minimum age for tobacco sales to 21, according to the anti-smoking Campaign for Tobacco-Free Kids. So have 470 municipalities, including New York City, Chicago, Boston and Minneapolis. Even so, the use of e-cigarettes and vaping has surged, with much of the increase among teenagers. The CDC says most e-cigarettes contain highly addictive nicotine, which can harm the development of young people’s brains and may them likelier to smoke cigarettes later in life. “Youth vaping is a public health crisis,” McConnell said. “It’s our responsibility as parents and public servants to do everything we can to keep these harmful products out of high schools and out of youth culture.” A government survey found that last year 1 in 5 U.S. high school students reported vaping the previous month. “Today, we are coming together to side with young people’s health,” said Kaine, acknowledging the rarity for bipartisan legislation at a time when the two parties can seldom find middle ground. The bill quickly won the endorsement of the American Cancer Society. Its advocacy organization, the Cancer Action Network, said the measure was a “welcome indication that Congress is taking the alarming crisis of increased youth tobacco use seriously and is committed to taking action.” The group also warned the sponsors to resist amendments that could let the federal government pre-empt stronger measures by states and municipalities, exempt some young people or exclude certain products. A similar bill was introduced last month by Sens. Brian Schatz, D-Hawaii, Todd Young, R-Ind., Dick Durbin, D-Ill., and Mitt Romney, R-Utah. Most experts agree e-cigarettes are less harmful than the paper-and-tobacco variety because they don’t produce all the cancer-causing byproducts found in smoke. But researchers say they are only beginning to understand the risks of e-cigarettes, which they think may damage the lungs and contribute to precancerous growths. McConnell has long been involved in tobacco issues. He helped pass the 2004 tobacco buyout, when the government provided billions of dollars for growers who lost money with the end of federal price supports. Kentucky has the highest cancer mortality rate in the country, with nearly 186 deaths per 100,000 residents in 2017, according to the federal Centers for Disease Control and Prevention. As health concerns about tobacco have grown in the U.S., demand and production of the crop have fallen in Kentucky, where it had long been a pillar of the state’s economy. Growers have been relying increasingly on industrial hemp, which McConnell has helped legalize. The CDC calls tobacco products the country’s top cause of preventable disease and death, with almost 40 million adult cigarette smokers. The agency says around 4.7 million middle school and high school students use at least one tobacco product, including e-cigarettes. Treating adults with smoking-related diseases costs the country nearly $170 billion annually for medical care. The country’s biggest tobacco company, Altria Group, has invested in the e-cigarette company Juul and has backed bills raising the minimum age for buying tobacco and vaping products to 21. Critics have suggested that support is aimed at forestalling tougher restrictions such as banning flavored vaping products and menthol cigarettes. ___ AP Health Writer Matthew Perrone contributed to this report.

SOLUTION: Senate GOP leader would raise age for buying tobacco to 21.

PROBLEM: Entitled “Beyond The Physical: A Symposium on Mental Health in Sports,” the forum will feature a series of panels with current and former NFL players as well as mental health organizations, caregivers, medical providers and media personalities. The aim is to raise awareness of mental health and promote a culture in which people, including athletes, are encouraged to seek help and support to achieve overall wellness. Confirmed panelists include NFL wide receiver and co-founder of Project 375 Brandon Marshall;  former NFL cornerback Asher Allen; former Pro Bowl running back Warrick  Dunn; Atlanta Falcons senior director of player affairs Kevin Winston; and representatives from Active Minds, Mental Health America (MHA) of Georgia, the American Psychological Association, and Campaign to Change Direction. “May is Mental Health Awareness Month and the NFL is pleased to partner with the NFLPA and Cigna to increase awareness and decrease the stigma around mental health ...” said Dwight Hollier, the NFL’s vice president of wellness and clinical services. “This effort is especially important in light of the messages young athletes receive about toughness and the need to be strong all the time. Through our discussions with caregivers, athletes, professionals and others, we will shine a light on mental health in sports and discuss ways to support athletes and others on the journey toward total wellness.” ___ For more NFL coverage: http://www.pro32.ap.org and http://www.twitter.com/AP_NFL

SOLUTION: NFL, union to host symposium on mental health on May 14.

PROBLEM: We’re told a 12-week regimen costs $54,600. However, we’re not clued in as to how much a 16-week treatment costs and that’s important since some of the trials lasted 16 weeks. Generally, according to the NIH, treatments take anywhere from 24 to 48 weeks. It’s unclear if this is true of Zepatier, although the results seem to indicate one round of treatment is all you need. There’s also a notable addition in this release in regard to cost: Financial assistance that brings the cost down to “as little as $5 for each prescription” for private insurance plans that aren’t generous when it comes to drugs. As the recent HealthNewsReview.org post by Lieberman might suggest, this is part of a growing trend to conceal the true cost of expensive drugs to the consumer, forcing those with more substantial insurance plans to foot the bill. “Do we want the health system to work for a few or for everyone?” Lieberman wrote. “That should guide our reporting when the next news release touting the newest specialty drug shows up.” After 12 to 16 weeks of treatment, Merck claims its drug can cure two types of hepatitis C in 94% of people. This includes people who had cirrhosis, HIV or kidney impairment. However, it should have been explained that the response or “cure” refers only to the reduction of viral load, which does not address long-term effects or adverse effects of the drug. The benefits are given in absolute terms, but viral loads are not reported and the response or viral loads in the placebo group are not reported at all in the release. This would be a critical element to be adequately reported in describing the results of studies on the efficacy of a particular drug. Finally, since some of the patients already had cirrhosis, there is no way the drug can prevent this outcome, and the needed study outcome should be reduction in the rate of liver or other GI cancers. The discussion on harms includes a long list of drugs to avoid mixing with Zepatier as well as common side effects and adverse reactions including headaches, fatigue, nausea, and anemia in about 5% of people who took the drug. Although we wouldn’t expect harms from placebo to be severe, we expected to see at least a mention of them since the drug was compared against placebo. And, since the minor harms were listed so extensively, we would have liked to see a mention of the risks for more rare but serious side effects due to the drug. In its news release on the approval, the FDA writes, “Zepatier carries a warning alerting patients and health care providers that elevations of liver enzymes to greater than five times the upper limit of normal occurred in approximately 1 percent of clinical trial participants, generally at or after treatment week eight.” Drugs must pass high bars to achieve FDA approval, and here we’re given the detailed results in five randomized, double-blind clinical trials for one form of hepatitis C (GT1 HCV) and one trial for another — GT4 HCV. Each of the trials used a few different populations with different pre-existing conditions. Despite the exhaustive accounting of study results, we’ll ding the release here for not acknowledging that the studies were all designed to find the “disease oriented” and not “patient oriented” outcomes. This means that the trial looked at the reduction in viral load, not the prevention of specific conditions like cirrhosis, an outcome that is supposed to be prevented by the use of these drugs. Patients care most about conditions that affect them and not how many virus particles are in their blood, so this was an important omission. There are no harrowing, overly dramatic details here. Merck is clearly labeled as the sponsor of the release. In the clinical trials section, some alternative treatments are named, including “IFN or PegIFN ± RBV” and “boceprevir, simeprevir, or telaprevir in combination with PegIFN + RBV.”  We’ll award a Satisfactory on that basis, although the trials mentioned are all compared against placebo and not these drugs. It would have helped to know what those treatments are, and their effectiveness. We will note, however, that highly successful curative hepatitis C treatments are very new — basically, within the past few years. The alternatives prior to that were liver transplants, which can cost $300,000, and viral interferon treatments, which were less than 50% effective. Merck’s release states the drug will start shipping to wholesalers within 7 days of Jan. 28, 2016. This is the second one-pill, once-a-day option for hepatitis C. We don’t think the release demonstrates novelty. “Multiple therapeutic tools” to treat hepatitis C are mentioned in a quote by the executive director of the Hepatitis Education Project, but we’re not clued in to what those are or where Zepatier fits in. Alternative drugs have similar, albeit slightly lower, cure rates in the high-80% to low-90% range. We see the word “cure” four times in the release. The release defines its use of the term cure early on in the release as “Sustained virologic response is defined as HCV RNA levels measuring less than the lower limit of quantification at 12 weeks after the cessation of treatment (SVR12), indicating that a patient’s HCV infection has been cured.”  We disagree because there’s no indication that these “sustained” responses are prolonged for a long period after the drug is discontinued.

SOLUTION:
Merck Receives FDA Approval of ZEPATIER™ (elbasvir and grazoprevir) for the Treatment of Chronic Hepatitis C Virus Genotype 1 or 4 Infection in Adults Following Priority Review