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: They found several creams caused skin cancer in the specially bred mice, which had been pre-treated with ultraviolet radiation. The cancers are not melanoma, the deadliest kind of skin cancer, they stressed in their report in the Journal of Investigative Dermatology, but another type called squamous cell carcinoma. Such tumours are slow growing, highly treatable and only fatal if patients fail to have them removed. Allan Conney and colleagues at Rutgers University in New Jersey said they discovered the risk while testing a theory that caffeine could prevent skin cancer. “We sort of got into this by accident,” Conney said in a telephone interview. “We wanted a safe cream that we could put the caffeine into.”   They were testing specially bred albino mice, which are prone to develop skin cancer. The mice are pre-treated with ultraviolet radiation to simulate the effects of a human who has had heavy sun exposure in the past but then stopped — something that may be happening in the population as people realize the risks of getting a tan. Conney’s team decided to test the creams first and found that all four they tested caused tumours to grow on the mice. He said he does not know why, but suspects two ingredients — mineral oil and sodium laurel sulphate. “We’d like to understand the mechanism. What is most important is to see whether these moisturizing creams are tumorigenic in people,” Conney said. He said his lab is not equipped to do this but someone should. But he added, “I don’t think that people should be scared because this is a mouse study and we don’t know whether or not it applies to humans.”   Other experts were sceptical about the study. “This is a pretty artificial situation with the mouse skin primed by a lot of UV light to develop cancer,” Karol Sikora, Medical Director of Cancer Partners U.K. in Britain, said in a statement. Dr. Jonathan Rees, an expert in dermatology at the University of Edinburgh in Scotland, said squamous cell carcinoma was not a big health worry. “Non-melanoma skin cancer in man is very, very common and is almost 100 percent curable with an operation usually simpler than a tooth filling,” Rees said in a statement. Conney said the mouse was a commonly used model in skin cancer but said he agreed that it does not perfectly replicate human skin and human behaviour. He said his team approached Johnson & Johnson to create a cream without the suspect products and they developed one using other readily available ingredients. “They are things that are commonly used in many moisturizing creams,” he said. This cream did not cause the tumours in the mice, they said. He said Rutgers and Johnson & Johnson had patented the new cream jointly but did not know whether it would be commercially developed. A spokesman at the company was not immediately available for comment.

SOLUTION: Skin creams seen to cause tumours on mice.

PROBLEM: 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.

SOLUTION: FDA approves new, targeted treatment for bladder cancer

PROBLEM: The coronavirus has infected more than 168,000 people worldwide and killed at least 6,610, according to the World Health Organization (WHO). While the bulk of those infected experience only mild symptoms, it is severe or critical in 20% of patients. The virus mortality rate is about 3.4%, the WHO has estimated. As scientists scramble to develop a vaccine, researchers at Australia’s Peter Doherty Institute for Infection and Immunity said they had taken an important step in understanding the virus. By examining the blood results from an unidentified woman in her 40s, they discovered that people’s immune systems respond to coronavirus in the same way it typically fights flu. The findings help scientists understand why some patients recover while others develop more serious respiratory problems, the researchers said. “People can use our methods to understand the immune responses in larger COVID-19 cohorts, and also understand what’s lacking in those who have fatal outcomes,” said Katherine Kedzierska, professor of microbiology and immunology at the University of Melbourne, which took part in the research. COVID-19 is the disease caused by the coronavirus. As researchers monitored the Australian patient’s immune response, they were able to accurately predict when she would recover. Researchers did not name the patient, but said she was an Australian citizen who was evacuated out of Wuhan, the epicentre of the coronavirus outbreak in China. Health Minister Greg Hunt described the development as “world leading” and a major development in research on the disease. “It’s about fast-tracking a vaccine by identifying which candidates are most likely to be successful,” Hunt told reporters. “It’s also about fast-tracking potential therapies and treatments for patients who already have coronavirus.”  At least a dozen drugmakers around the world are working on vaccines or antiviral and other treatments for the fast-spreading contagion. But investment costs for vaccines could run as high as $800 million in a process that, even if accelerated, will likely take more than a year until approval, according to executives from companies involved in the effort.

SOLUTION:
Australian researchers map immune response to coronavirus.