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.

[EX Q]: The release does not mention cost. The FDA evaluates drugs without consideration of cost, so it’s understandable that they wouldn’t comment on it — and that’s why we’re rating this Not Applicable. But let’s be real here: The value of a new drug is a function not just of how well it works, but its cost-effectiveness. So we look forward to the day when any news release about a new drug — even one from the FDA — will include some mention of cost in its message. This release gives the preliminary results from a single study of 310 patients. Because the drug is experimental, long-term results haven’t been studied. Of the 310 patients enrolled in the lone trial upon which the approval is based, 14.8 percent showed some shrinkage of tumors during the assessment period lasting from 2.1 to about 13.8 months. For a subset of patients who were classified as having a positive response to PD-L1 expression, the response was 26 percent. As noted above, tumor shrinkage doesn’t always lead to improvements in survival or quality of life. It is a surrogate endpoint — a substitute — for the main outcome which is survival. Although this drug looks promising, to be fully transparent about its benefits as currently known, the release should have explained this. As noted in the “Summary,” another larger study is underway to assess the drug’s impact on extending life and improving quality of life. The release includes a description of side effects of this treatment. The most common ones included fatigue, decreased appetite, nausea, urinary tract infection, fever (pyrexia) and constipation. The release also mentions that patients taking the drug have an increased risk of infection and serious side effects that are “immune-mediated.” We would have liked a bit more context on what this term means for patients. The release outlines that this is the very first clinical trial of this compound for safety and efficacy, and under which regulatory paths the drug was assessed, including “breakthrough therapy designation, priority review status and accelerated approval.” We’re giving this release the benefit of the doubt and rating it Satisfactory for its bare bones description of the trial (and since we already addressed the lack of long-term survival data in the “Benefits” section.) As it stands, the results from the small trial were preliminary and short-term and did not reflect long-term survival. We would have liked to see a reference or link to the completed trial where one could look at the results to assess independently or learn more about the outcomes. We think the release should have provided more data on the patient demographics, the treatment regimen (dosing amount and schedule) as well as the range in tumor reduction. There is no disease mongering. This release describes the approval of a new drug by a regulatory agency, but we’d still like to know who sponsored the study that’s the basis for the approval. It’s not enough to state who markets the drug. The release does not give us very much information about alternatives. These patients had already received other therapy and their cancer had recurred, so it is implied that they had no other alternatives. But this isn’t stated very clearly. We can assume (and it seems evident) that the platinum-based therapy that the patients didn’t respond to initially is the usual treatment. The FDA’s approval of a drug clears the way for the drug sponsor to scale up production and begin marketing and selling the product. (The FDA doesn’t state this explicitly but it can be inferred.) A NYT article said the drug would be available in about two months. The release clearly states this product is first of its kind for this type of cancer. We found no unjustifiable language.
[EX A]: FDA approves new, targeted treatment for bladder cancer

[EX Q]: Major European stock markets dived more than 7%, Japanese indexes fell over 5% and U.S. markets sank over 7% after Saudi Arabia launched an oil price war with Russia that sent investors already spooked by the coronavirus epidemic running for the exits. In Italy, scene of Europe’s worst outbreak with infections and deaths still soaring, the government took its most drastic steps yet to contain the outbreak, affecting some 60 million people. It ordered everyone across the country not to move around other than for work and emergencies, banned all public gatherings and suspended sporting events, including soccer matches. Deaths in Milan’s Lombardy region - which had already been on lockdown with cinemas, theaters and museums closed and restaurant hours restricted - jumped 25% in a day to 333, while the national death toll soared by 97 to 463, the highest in the world after China. Over 9,000 people have become infected in Italy in little over two weeks, out of a global total of more than 113,000 in over 100 countries. Nearly 4,000 people have died across the world, the vast majority in mainland China. “Now that the virus has a foothold in so many countries, the threat of a pandemic has become very real,” World Health Organization Director-General Tedros Adhanom Ghebreyesus told a news conference. But he welcomed Italy’s tough measures, noting that just four countries - China, South Korea, Italy and Iran - accounted for 93% of cases worldwide. Israel ordered anyone entering the country to self-quarantine for 14 days on Monday. “It would be the first pandemic that could be controlled,” Tedros added. “The bottom line is we are not at the mercy of the virus.”  In the United States, which has reported over 600 cases and 26 deaths, the administration scrambled on Monday to assure Americans it was responding to the outbreak as stock markets plunged and top health officials urged some people to avoid cruise ships, air travel and big public gatherings. U.S. President Donald Trump, who continued to play down the threat posed by the flu-like virus, said he would announce economic measures on Tuesday and would discuss a payroll tax cut with Congress to bolster the economy. Trump recently spent time with two members of Congress, including one who rode on Air Force One, who are self-quarantining over concerns about exposure to the virus. Vice President Michael Pence said he did not know if Trump had been tested for coronavirus. Around the world, flights have been canceled, communities and cruise liners isolated, and concerts and trade fairs postponed. While some countries, such as China and Italy, have turned to drastic measures to try to delay the spread of the virus, others remain in a “containment” phase, where individual cases can still be tracked. Britain, with five deaths from almost 300 confirmed cases, said it would remain in that phase for now, allowing major gatherings and sporting events to continue, while making extensive preparations to move to the “delay phase.”  In neighboring Ireland, acting Prime Minister Leo Varadkar said a 3 billion euro ($3.4 billion) coronavirus package had been agreed. Funds set aside for a potential sudden rupture in trade ties with Britain, which has left the European Union, were to be diverted to coronavirus mitigation. Perhaps just as dramatically, Varadkar announced  cancellation of all parades planned for the national St. Patrick’s Day festival on March 17, including one in Dublin that draws more than 500,000 people from all over the world. In Spain, schools were closed across the Madrid region and the Basque capital Vitoria for two weeks as cases topped 1,200 nationwide. Prime Minister Pedro Sanchez said an emergency economic plan had been prepared. In the Gulf region, where most cases stem from travel from Iran, the emphasis has been on border control. Saudi Arabia said it would fine people who did not disclose health information and travel details at entry up to $133,000. Iran, with 7,161 cases and 237 deaths, said it was temporarily releasing about 70,000 prisoners because of the coronavirus. China and South Korea both reported a slowdown in new infections. Mainland China, outside the outbreak center of Hubei province, recorded no new locally transmitted coronavirus cases for the second day. South Korea reported 165 new cases, bringing the national tally to 7,478, while the death toll rose by one to 51. With the rate of increase in new infections at its lowest  in 11 days, President Moon Jae-in said South Korea could enter the “phase of stability” soon. In Italy, that phase still seems far off. Authorities said seven prisoners died as riots spread through more than 25 jails across the country over measures imposed to contain the coronavirus. Police and fire trucks massed outside the main prison in the northern town of Modena, the site of some of the worst violence. Barkeepers in Rome and Milan said police had visited them to warn that they risked closure if they let customers huddle together. “We went into the cafe together but were told to stand far apart. It was really odd because we are friends,” said Ilaria Frezza, a 21-year-old student. But the bar she was in was, in fact, almost deserted. “I wish I was having problems keeping people apart, but that’s the least of my worries,” said Franco Giovinazzo, who runs the Spazio Caffe in Rome. “The real problem is there’s no-one here.”  (Graphic: Coronavirus spreads in China and beyond, here)  (Graphic: Tracking the novel coronavirus, here)  (Online package of coronavirus news, here)
[EX A]: Stocks savaged, Italy on lockdown, Trump seeks to reassure as coronavirus spreads.

[EX Q]: Dr. Neelu Pal poses for a portrait in New York, July 23, 2010. Pal was fired weeks after authorities at New York University Langone Medical Center Surgical Weight Loss Program learned she had contacted patients about the dangers of Lap-Band surgery in January 2006. REUTERS/Shannon Stapleton Pal had previously raised her concerns with hospital officials, complaining — to no avail — about the lack of care given after surgery and incomplete or inaccurate medical forms that were taken prior to surgery. She was fired weeks after hospital authorities learned she had contacted patients in January 2006. She has filed a wrongful termination lawsuit — the case is pending — and enrolled in law school. Pal, who came to the United States from India a little over a decade ago to practice medicine, says she has been blackballed from her chosen profession. The NYU bariatric surgery practice where she worked is widely considered one of the world’s most experienced. But in an interview with Reuters, Pal described the facility as a hectic Lap-Band factory. “My impression at the time was that the practice was disorganized, but once I knew more about the system, I could see what they were trying to do was get as many patients on to the operating table as possible,” she said. During her three months at NYU Langone Medical Center’s Surgical Weight Loss Program in late 2005 and early 2006, two surgeons — Dr. Christine Ren and Dr. George Fielding, who are married — implanted gastric bands into as many as 20 patients in a single day, according to Pal. Known as pioneers in the field, Fielding and Ren are also paid consultants of Allergan Inc, the Botox and breast implant maker which is the leading manufacturer of the gastric band. Though rivals have been gaining, Allergan’s Lap-Band still commands more than two-thirds of a $300 million to $400 million market. To critics, Pal’s allegations — some of which were corroborated by a New York State Health Department investigation around that time — underline the potential risks that go along with the industry’s rapid growth. And the business could soon swell even more if U.S. regulators grant permission to perform the procedure on the nation’s bulging ranks of overweight teens. Ren was an investigator in an Allergan-sponsored clinical trial studying the use of bands on teens. And the company has an application with the U.S. Food and Drug Administration seeking approval to market the device to teens as young as 14. A decision could come any time. Winning regulatory approval for the gastric band in teenagers would allow the companies that make the devices — Allergan, Johnson & Johnson and others — to target that specific age group. Today, regulators consider performing the procedure on teens “experimental” as it has not been approved for that age group. But, like any device, it may be used on teens at a doctor’s discretion. Allergan declined to comment on Pal’s lawsuit or disclose how much it pays the surgeons, though the company did confirm that both remain on the payroll. Through a NYU spokeswoman, Ren and Fielding — who have been the subject of some controversy — declined to be interviewed for this article, also citing the lawsuit. But in some medical circles, concern over gastric banding for teenagers is growing nearly as fast as American waistlines. In particular, some doctors worry about the device’s long-term safety and effectiveness. A gastric band is just what it sounds like: an inflatable silicone band placed around the top portion of the stomach to create a pouch that restricts food intake. It has become increasingly popular in the United States in recent years, and results in reasonable weight loss. The procedure is considered less invasive and risky than gastric bypass. Banding could also be an especially attractive option for teens, say proponents, because it is reversible, whereas bypass is not. The 30- to 60-minute procedure, typically performed with a laparoscope, might require one night in the hospital but can also be done on an outpatient basis. But certain data show gastric bands are less effective and more problematic for teens than adults, said Dr. Thomas Inge, chair of a government study to assess bariatric surgery in adolescents called Teen Longitudinal Assessment of Bariatric Surgery, or Teen-LABS for short. The Teen-LABS study aims to determine if adolescence is the best time to intervene with surgery. It was launched in 2007 and is expected to report results in about five years. In more than one in five teens in another study, Inge noted a high rate of “symmetric pouch dilation” — a complication in which the small pouch created at the top of the stomach by the band gets bigger, allowing patients to consume more food. This issue was reported in the journal Obesity Surgery, and later in the Journal of the American Medical Association. “We await the U.S. trial data, PMS (post-marketing surveillance) data, and confirmation from non-industry-run trials to make final recommendations,” said Inge, who is the surgical director of the weight loss program for teens at Cincinnati Children’s Hospital. As Inge and others are quick to point out, trials that studied how teens fared with a gastric band over the short term have been few, and those that were conducted show the device generally is safe and effective, with a relatively low risk for complications or death. But there is a dearth of long-term data on the outcomes from gastric band surgery. And that worries Dr. Mary Brandt, an investigator in the Teen-LABS study, among other experts. “I think there’s a fundamental problem with putting a rigid plastic object around a moving organ. You’re asking it to stay in place and not erode over a long period of time,” said Brandt, who is also director of the pediatric surgical program at Texas Children’s Hospital in Houston. “I’ll be happy to reverse my position as soon as I see 10 or 20 year data. Unfortunately, that’s not something that industry is excited about funding.”   She acknowledged a bias against gastric bands, citing a Swiss long-term follow-up study of 167 adults that showed the band failed almost a third of the time after 10 years. About a fifth of the patients required another operation. And while fewer than 8 percent reported complications in the 30 days following surgery, more than 40 percent had problems after a decade. Long-term complications included the erosion and slippage of the band, both of which might require another operation, and a dilation of the esophagus, which could result in difficulty swallowing. Infections around the port that sits below the skin and allows the doctor to add or remove saline with a syringe to tighten or loosen the band, as well as leaks, were also common. “Bands are definitely safe in the short term and definitely work in the short term. What we don’t know is about the long term,” Brandt said. “I’m not saying it should never be used. We just have to be more careful about how we’re using it.”   The Swiss study of adults who had gastric banding, published in Obesity Surgery, came to the same conclusion. Because of complications, the need for another operation, and long-term failure rates, gastric banding should be performed in “selected cases only” until more data are available, it said. Another group of 276 adults who underwent gastric band surgery had similarly disappointing results in a long-term Austrian study published in the same journal. Only a little under 54 percent of the patients still had their original band after nine years, with nearly 18 percent having the original replaced with a new one and nearly 29 percent having it removed. Of those who no longer had any band, more than half had a second bariatric operation. Gastric banding demands that teens do something they often aren’t very good at — sticking to a rigorous follow-up routine. Dr. Roberta Maller Hartman, a psychologist and Lap-Band patient herself, counsels teens and adults after receiving the gastric band. “I’ve worked with a lot of high school students and they just want to be like everyone else and go out and eat pizza with their friends,” she said. “They can, but they have to take little bites and chew a lot.”   Success depends most on a patient’s ability to modify their behavior. “The band doesn’t reduce the desire to eat emotionally. That has to be addressed,” said Dr. Maller. “Teens tend to need more hands-on, one-to-one support.”   Indeed, there are many success stories of obese teens losing weight, keeping it off and staving off a host of related illnesses, such as diabetes, arthritis and high blood pressure. Surgery — banding or bypass — has been shown to produce the most sustainable results when compared with diet and exercise. Nevertheless, critics abound. Dr. Susan Woolford, Medical Director of the Pediatric Comprehensive Weight Management Center at the University of Michigan, conducted a study, published in Obesity Surgery, to find out how readily primary care physicians and pediatricians — those in the front lines of obesity treatment — would refer patients for bariatric surgery. Nearly half, or 48 percent of the 381 physicians surveyed, said they would never refer an adolescent for any type of bariatric surgery. The controversies swirling around NYU’s influential bariatric surgery center — as well as its two top surgeons — have done little to ease concerns. An investigation by the New York State Department of Health in 2006 found that Fielding falsified data on Vincent Esposito, a 14-year-old boy who was part of the FDA-authorized study that was looking at the use of the device in obese teens. A week after Esposito’s Lap-Band surgery, he developed an infection with an abscess — a common complication with gastric banding — and returned to the NYU facility, where Fielding performed an appendectomy. The investigation by New York health authorities determined there was no evidence of appendicitis, according to the report. “They told me I was a ticking bomb,” Esposito had told the Daily Times in Salisbury, Maryland in 2007, referring to his obesity. Reached by telephone, his father said his son was “fine” and that they are being represented by an attorney and declined to comment. NYU also declined to comment. In its response to the NYDH report, the university maintained no wrongdoing, saying “the surgeon probably misinterpreted his operative findings.” In a statement at the time, the school added, “...we are persuaded that he assumed that the infection did not begin in the gastric band device.”   The response and NYU’s plan to correct the issues were accepted by state regulators. In the NYSHD report, Fielding was also cited for failing to address a post-operative patient’s persistent lack of urine output. The patient went into cardiac arrest and died 36 hours later. This was the death that alarmed Pal and led her to warn patients. The same report said the program director, Ren, had permitted two surgeons to practice without the appropriate licenses, in violation of the law. For four months, the unlicensed physicians “performed multiple surgical procedures, made pre- and post-op assessments, and wrote orders to be carried out by nursing staff,” the report said. After Ren learned she was being investigated by an internal committee, she went back and removed the name of the unlicensed surgeon from the operative report, according to court testimony. She was found to have committed professional misconduct and received a letter of reprimand that was put in her file for a year. Fielding, who got a gastric band himself in 1999, is from Australia, where he left behind multiple personal injury lawsuits, most of which have been settled. Dr. Robert “Skip” Nelson, a pediatric ethicist at FDA, said he had no specific knowledge about the incident at NYU Medical Center. If the agency did learn that an investigator has entered false data, he said, there would be an investigation. He added that if the FDA doubted the integrity of the data, they would not be considered in the decision-making process. An investigator, as doctors who run clinical trials are called, could also be disqualified as a result. Despite the reports of misconduct, the NYU Langone Weight Management Program has retained its status as a “Center of Excellence,” a designation conferred by the Surgical Review Corp, an entity created by the American Society for Bariatric and Metabolic Surgery. Surgical Review Corp CEO Gary Pratt said that he was unaware of the incidents and the NYSHD report. He said the corporation’s reviews maintain the highest standards with the goal of advancing the safety and efficacy of bariatric surgery. The company intends to put out a new list of approved bariatric clinics that treat teens later this year — which may coincide with the FDA granting approval, or not. If the FDA does greenlight it, insurers would be more likely to pay for the procedure, which costs the insured patient $2,000 to $4,000. The uninsured, making up about a third of patients who have the surgery in the United States, pay about $15,000 for the surgery. Some health professionals worry that band manufacturers will target teens with direct-to-consumer (DTC) ads on television and radio or in subway stations that have proven effective at luring people to doctors’ offices. The FDA said there is no guidance or regulation on DTC ads to young users. For Allergan, based in Irvine, California, the implications are significant. And the company is acting accordingly. It recently launched a campaign with bariatric surgeons to invite their patients to enter an essay contest and win a chance to go to Washington, D.C. to “share their personal stories with legislators and media.”   Allergan has seen its stock underperform the S&P 500 year to date. Botox remains its key product and has weathered increased competition amid the recession, while obesity intervention was hit hardest by the economy. At the same time, Lap-Band has also been slowly losing market share to Johnson & Johnson’s competing device called Realize. In 2009, Allergan’s obesity products generated revenue of $258 million, down 13 percent from 2008. Management is betting that continued investment in direct-to-consumer advertising will stimulate growth in the obesity segment, said Gleacher & Co analyst Amit Hazan. He estimates there will be 83,500 gastric band procedures in the United States in 2010, up 6 percent from 2009. Sanford Bernstein analyst Aaron Gal said FDA approval of the Lap-Band for teens could increase sales by as much as $20 million for Allergan. Even critics of gastric band surgery acknowledge that there are few good solutions to adolescent obesity. It is a mounting problem, affecting nearly 1 in 5 American teens, and many doctors believe that it should be addressed sooner rather than later when other health problems can develop. Some experts are wary but believe the benefits may outweigh the potential harm. “My conclusion is that it makes sense to intervene sooner because surgery can head off other related problems. Kids are better surgical risks, but the downside is that I suspect most teenagers are doing it less for health and more for social and psychological reasons,” said Dr. Jeffrey Zitsman, who is leading an independently funded teen study at Columbia University. Those who do it out of vanity, he cautioned, may have a harder time. “When health reasons don’t motivate them,” he said, “sometimes there are compliance issues.”   Yet, Dr. Robert Murray, director of Nationwide Children’s Hospital Center for Healthy Weight and Nutrition, argues that the heavy psychological problems obese teens carry should not be ignored. “They’ve been teased out of school, they have social issues, many are depressed, and their quality of life is equal to that of a kid with cancer,” he said. “If you get them at 14 and reverse weight and health problems, they’ve got a shot at a normal life.”   To critics, at least, the question is at how big a price.
[EX A]:
Special report: Targeting teens for gastric bands.