instruction:
Generate an explanation for the given claim using the provided supporting material from the paragraph. Please consider the following points while generating an output. 1) The claim will always have supporting proof in the paragraph, and the paragraph will have a clear point of view supporting the claim. 2) There can be instances where direct correlation to the claim is not available. Make use of the sentences in the paragraph to provide a corresponding output supporting the claim. 3) The explanation should be at least one and at most twelve sentences long.
question:
Paragraph: In January 2020, readers asked us about the accuracy of a story that claimed the U.S. Food and Drug Administration (FDA) had approved a new cocaine nasal spray for use as a local anesthetic. On Jan. 13, the cannabis and drug industry website Merry Jane published an article with the headline “A Cocaine Nasal Spray Just Received FDA Approval.” That article reported that: Medicinal cocaine has always been a thing, but now there’s an FDA-approved nasal spray aptly made with totally legal, pharmaceutical-grade white. On Monday, the pharmaceutical outfit Lannett Company announced that its new cocaine hydrochloride nasal spray product, dubbed Numbrino, cleared two Phase III, randomized, double-blind clinical trials. “The FDA’s approval of our cocaine HCl product, the first NDA approval to include full clinical trials in the company’s history, marks a major milestone in Lannett’s 70+ years of operations,” said Tim Crew, Lannett Company’s CEO, in a press release. “We believe the product has the potential to be an excellent option for the labeled indication. We expect to launch the product shortly …” The pharmaceutical company’s press release, also published on Jan. 13, read as follows: “Lannett Company, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA), submitted under the 505(b)(2) regulatory pathway, for Cocaine Hydrochloride (HCl) Nasal Solution 4% (40 mg/mL), the company’s branded local anesthetic product … NUMBRINO® (cocaine hydrochloride) nasal solution is an ester local anesthetic indicated for the introduction of local anesthesia of the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities of adults.” Claim: In January 2020, the Food and Drug Administration approved a nasal spray containing cocaine. 
answer:
The press release, and Merry Jane’s article, were accurate. In a Jan. 10 letter addressed to Cody Laboratories, a subsidiary of the Philadelphia-headquartered Lannett, the FDA’s Center for Drug Evaluation and Research wrote:


question:
Paragraph: Israel-based BrainStorm said on Monday a case report is being published in the February issue of “Muscle & Nerve” by the principal investigator and his colleagues at Hadassah Hospital in Jerusalem and a professor from the Mayo Clinic in Minnesota. The report is already available online. A 75 year-old-man diagnosed with both MG and amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s Disease, was treated with BrainStorm’s NurOwn cells. Both are neurodegenerative diseases. One month after receiving injections of the cells, the patient and his family reported significant improvement in cognition, speech, and muscle power. After six months, due to progression of weakness and deterioration in cognition, a repeat injection of NurOwn was performed. Again, improvements in the ALS functional rating scale were observed, the report said, adding that treatment with NurOwn appeared safe and well tolerated. “The results suggest that repeated therapy may maintain and enhance the clinical benefits of NurOwn cell therapy in neurological diseases,” it said. Chaim Lebovits, president of BrainStorm, said the report in “Muscle & Nerve” was very promising. “This publication is an important milestone for BrainStorm as this is the first human data on NurOwn to be published in a prestigious scientific journal,” he said. He said the company expects to finalize its Phase IIa clinical trial in the first half of 2014. According to the ALS Association, 5,600 people in the United States are diagnosed each year with the disease, which has severely disabled British physicist Stephen Hawking. Claim: BrainStorm says stem cells helped patient with ALS and MG.
answer:
A patient suffering from both ALS and myasthenia gravis (MG) showed significant improvement in cognitive and motor function following treatment with BrainStorm Cell Therapeutics adult stem cells, according to a published case report.


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Paragraph: Researchers studied the medical records of more than 1 million children and young adults aged 2 to 24 who were taking or had taken stimulants such as Ritalin or Adderall and found no sign of increased risk of heart problems. “We don’t see any evidence of increased risk,” said Dr. William Cooper of Vanderbilt University, whose study was published in the New England Journal of Medicine. The study in children is the first of three commissioned by the Food and Drug Administration to understand the potential heart risks of the drugs after U.S. and Canadian regulators received a number of reports in 2006 of heart attacks, strokes and sudden cardiac arrest in children taking the medications. The reports prompted several FDA advisory committee hearings on heart problems, and Health Canada temporarily suspended marketing of ADHD drugs. The concerns also prompted the American Heart Association to issue guidelines suggesting that children who were just starting to take the drugs should be tested for potential underlying heart problems. “There was a lot of concern and confusion among families and providers about what the best approach would be to treating kids who had ADHD and who might benefit from these medicines,” Cooper said by phone. ADHD is one of the most common child mental disorders, affecting around 3 to 5 percent of children globally. Children with ADHD are excessively restless, impulsive and easily distracted, and often have trouble at home and in school. There is no cure, but the symptoms can be kept in check by a combination of behavioral therapy and medication. In the United States, some 2.7 million children have prescriptions for ADHD drugs including Novartis’ Ritalin or methylphenidate and Focalin; Johnson & Johnson’s Concerta, Shire’s Adderall and Vyvanse and Eli Lilly’s Strattera. For the study, Cooper’s team used prescription data from four large, geographically and demographically diverse health plans on 1,200,438 children and youth, including both current and past users of the drugs. They checked health records for evidence of heart problems, including heart attacks, strokes and sudden cardiac deaths, in children who were currently taking the drugs or who had taken them. The team found no increased risk of heart problems for either current or past users of the drugs. Yet because there were so few cases of serious heart problems — just 81 — the study may not have been large enough to detect it. But even if there were a risk of heart problems, it is extremely slight, Cooper said. In a guidance document issued on Tuesday, the FDA said it continues to recommend that the drugs not be used in patients with serious heart problems. It added that patients should be monitored for changes in heart rate or blood pressure. Jefferies analyst Peter Welford said the findings will likely reassure investors in Shire, maker of Adderall and Vyvanse. But because there were so few heart problems, the study was underpowered and cannot conclusively dispel concerns about cardiovascular risks. Shire’s shares were flat on Tuesday, outperforming a sharply lower market. Claim: ADHD drugs do not increase heart problems in kids.
answer:

Stimulants used to treat attention deficit hyperactivity disorder do not increase the risk of heart attacks, strokes or sudden death, U.S. researchers said on Monday, in a finding that should reassure millions of parents whose children take the drugs.