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.
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Question: Although this therapy is not yet available for patient use, the story makes a point of noting that the cost may well be “stratospheric,” should it make it to market. If approved, such treatments are expected to command stratospheric prices. For example, a separate Spark gene therapy for a rare type of childhood blindness, which is on track for Food and Drug Administration clearance soon, could cost $1 million per patient for infusions in both eyes, according to some Wall Street analysts. Still, the therapies can produce at least some offsetting savings. Porteus noted in his editorial that the hemophilia therapy resulted in savings of about $200,000 a year per patient because of the elimination of clotting-factor infusions. The story summarizes the outcome of the small, 10-person trial that dominates this narrative: Lindsey George, the lead investigator and a hematologist at Children’s Hospital of Philadelphia, said that nine of the 10 men in the trial didn’t experience any bleeding episodes after the gene therapy treatment. The one patient who needed clotting factor because of bleeding used 91 percent less than before, she said. Although the story does not address harms directly–and should have–it does note that one of the worrying side effects of gene therapy—spurring the body to attack itself—was not present in this study. It is clear from the story that the study is small and an “early-stage trial.” One source also notes that the researchers tracked individuals in the study for no more than a year and a half, making longer term assessments unavailable. The story could have done more, though, to signal to the reader that, despite the encouraging outcomes of the study, the treatment is still very much under development. The next stage—Phase 3 trials—requires more participants, more careful study design, and takes, on average, three years to complete. The treatment described here, if ultimately proved worthy, could have a profound impact on a serious genetic condition. Independent sources are identified in the story, as are the funders. But missing from the text is information describing linkages between the two funders—Spark Therapeutics and Pfizer—and the lead researchers. It’s not clear from the story that there is a financial relationship. Individuals coping with hemophilia B have few options, and the story describes the main one: injections of blood-clotting factor to stem runaway bleeding. Since the story notes that the research is at an early stage with only 10 participants, a reader can easily infer that the treatment is not yet available. However, additional information about remaining evaluation stages for this treatment would have been a useful reinforcing addition. Hemophilia B sufferers who see this story will likely be contacting their doctors. The story establishes novelty with this: The researchers presented earlier findings on the gene therapy a year ago at the American Society of Hematology’s annual meeting, but the latest data covers a larger patient group and a longer time period. A news release issued by Children’s Hospital of Philadelphia did a good job of describing this study; the Post story could have picked up more of the salient details from that text but reveals independent reporting nevertheless by including sources not connected to the study.

Answer: Gene therapy makes a big advance treating hemophilia B blood disorder


Question: While governments in at least 20 other states obtained more than 30 million doses of the drug through donations from the federal reserve or private companies, Oklahoma and Utah instead bought them from private pharmaceutical companies. Top officials in both states chalked up the decisions to “the fog of war.”  Oklahoma Gov. Kevin Stitt on Tuesday defended the state’s $2 million purchase, saying the drug was showing some promise. His health secretary attributed buying the 1.2 million hydroxychloroquine pills to something that happens in the “fog of war.”  Utah Gov. Gary Herbert at first defended the state’s $800,000 purchase of 20,000 packets of hydroxychloroquine compounded with zinc, but has since ordered an investigation of a no-bid contract with a local company that had been promoting the drugs. Herbert, a Republican, also canceled an additional plan to spend $8 million more to buy 200,000 additional treatments from the same company. A left-leaning nonprofit group in Utah filed a price gouging complaint Tuesday with state regulators, arguing the $40 per pack drug was grossly overpriced. Oklahoma’s attorney general requested an investigative audit on Tuesday of its Department of Health over spending and warned the agency about retaliating against employees who report wrongful government activities under the state’s Whistleblower Act. A spokesman for Attorney General Mike Hunter declined to comment on whether the request was related to the $2 million spent on the drug. Doctors can already prescribe the malaria drug to patients with COVID-19, a practice known as off-label prescribing, and many do. But the U.S. Food and Drug Administration on Friday warned doctors against prescribing hydroxychloroquine for treating the coronavirus outside of hospitals or research settings because of reports of serious side effects, including irregular heart rhythms and death among patients. Preliminary results from a recent study done on coronavirus patients at U.S. veterans hospitals showed no benefit, casting more doubt on the drug’s efficacy during the pandemic. Those were the latest admonitions against the drug that Trump has regularly promoted in public appearances, touting its potential despite his own health advisors telling him it is unproven. Oklahoma acquired 1.2 million pills, or about 100,000 doses, on April 4 from FFF Enterprises, a California-based medical supply wholesaler, according to the Oklahoma State Department of Health. Oklahoma state Rep. Melissa Provenzano, a Democrat from Tulsa, said the state’s purchase shows that Gov. Stitt’s actions don’t follow his claim that he relies on data to drive his decisions. “Two million dollars is a lot of money to waste, especially when we have unemployment claims approved yet going unpaid, health care professionals without proper protective equipment, and diagnosed cases and deaths continuing to rise,” Provenzano said. Stitt, a first-term Republican, said hydroxychloroquine was showing some promise as a treatment in early March, and he didn’t want Oklahoma to miss out on an opportunity to acquire it. “Now there’s some evidence the chloroquine may not be as effective, but I was being proactive to try and protect Oklahomans,” Stitt said Tuesday when asked about the purchase. “That’s always going to be my first instinct, to get the equipment and things we need that I’m seeing in the future would help Oklahomans.” Oklahoma’s Secretary of Health Jerome Loughridge said several physicians, including some in Oklahoma, were previously optimistic about the drug’s promise in treating COVID-19. He added that the drug is also useful for treating lupus and some other auto-immune diseases, so the state’s supply “will not have gone to waste.” “When we were battling sort of the fog of war at that point, we certainly acquired it on the potential that it would have utility,” Loughridge said. Jeff Burton, a former adjutant general of the Utah National Guard chosen to lead the state health department’s coronavirus task force, offered a similar explanation for why the state made its purchase. He said the state never received the pills and is trying to get its money back. “I chalk it up to fog of war,” Burton told the state’s pharmacy board. “There was a lot going on. It’s easy to judge it from (an) easy chair.. . . Since then we’ve decided that was not a wise purchase.”  Doctors in Oklahoma have been using the drug to treat patients with COVID-19, often in conjunction with a second drug, azithromiocin, but the results “just are not that promising,” said Dr. Douglas Drevets, chief of infectious diseases at University of Oklahoma Medicine. FFF Enterprises said it’s the company’s policy not to comment on transactions with customers. Utah gave a local company called Meds in Motion the $800,000 contract without taking bids from other companies under emergency procurement rules, said Christopher Hughes, director of Utah’s division of purchasing. State officials haven’t explained why they didn’t seek to get the drugs for free. The Federal Emergency Management Agency said Saturday it has sent out 28.6 million tablets of hydroxychloroquine sulfate free of cost to states around the country. Several states including New York, Connecticut and Texas received donations of the medication from a private company based in New Jersey called Amneal Pharmaceutical, according to information compiled by The Associated Press. Utah taxpayers deserve to know what happened to allow a purchase that seems like a company taking advantage of the early, chaotic days of the pandemic, said Chase Thomas, executive director of the group called Alliance for a Better Utah that submitted the price gouging complaint. The complaint alleges Utah paid at least double the common price for the medication. “Whether they were buying drugs we didn’t need or paying too much for it when they could have gotten them for free, there just needed to be a lot more thought going into this,” Thomas said. Meds in Motion didn’t answer an email seeking comment about the allegations. Herbert declined to provide an update Tuesday about the investigation of the purchase. He said Friday the state’s legal counsel would aim to find out what, how and why it happened. He said he believed state officials acted in good faith as they scrambled to slow the spread of coronavirus, but acknowledged a mistake may have been made. “I have some questions about how it came about,” Herbert said Friday. “Bottom line is, we’re not purchasing any more of this drug.”  ___ McCombs and Whitehurst reported from Salt Lake City.

Answer: Oklahoma, Utah face scrutiny over malaria drug purchases.


Question: The story does a good job of pointing out one advantage of the pill approach compared to delivery via colonoscopy–the reduced cost. “There was a significant difference in cost. Though the procedures were done in a Canadian hospital, the FMTs delivered by colonoscopy cost nearly $500 USD more than the capsules, which cost about $300.” This was a close call. Early on, it says the pill was 90% effective for treating recurrent Clostridium difficile infections. Later on, the story explains that both were equally successful in treating the Clostridium difficile infections. It would take a bit of deduction to figure out that the 90% treatment rate applies to both the pills and colonoscopies. And the study puts this figure close to 96%. But we’ll give the benefit of the doubt and rate it satisfactory. The story gets a satisfactory here for including the differences between the two methods of delivery: One source is quoted saying, “colonoscopies and the anesthesia required for the procedure can put a lot of stress on a person’s body and can be complicated for the people most at risk for C. difficile infections.”  It could have gone a step further and reminded readers that a colonoscopy is an invasive procedure with the inherent risks of infection and perforation that obviously aren’t there when taking a pill. The story did not mention the other adverse events described in the paper such as nausea and vomiting, though. The story comments on the size of the study and quotes a researcher about strengths (a randomized, controlled trial) and limitations (selection bias) of the study. Selection bias, in this case, means many people were excluded from the clinical trial if they had any number of issues (patients with severe or complicated cases were excluded, for example), potentially biasing the results. In a more real-world setting, the effectiveness rate may drop once it’s tried on a wider range of people. No disease mongering here. The story does include comments from an independent source unaffiliated with the research. But, it doesn’t specify that the source has received research money from a drug company that’s developing microbiome drugs. Standard treatment for C. diff is antibiotics. This should have been mentioned. Unfortunately, the story doesn’t spell out whether the pill form FMT is now, or soon will be, available to the public. The story does mention that numerous other clinical trials are using FMT as a possible treatment for various diseases but it is unclear whether the pill form is an option for physicians at this point. What’s new here is that a pill form for delivery of a fecal transplant is being tested against a colonoscopy. The story established this. It does not appear to rely on a news release.

Answer:
Fecal transplant via a pill? Newsweek’s coverage points out possible selection bias of study participants