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.

Q: The story does not describe the costs of uterine artery embolization or how they compare to costs of surgery. The cost of UAE is quite high and for some women may not be covered by insurance. The story provides adequate quantification of some of the most important things for consumers to know, such as the fact that after a year, there were no differences in the quality of life of the women assigned to uterine artery embolization compared to those assigned to surgery and that 13% of those who underwent UAE had a repeat hospitalization, mostly for surgical intervention because of failure of UAE to achieve the desired results. The story could have provided more quantification of other pieces of information that women would want to know, such as length of hospital stay, time to return to work, or risk of serious adverse events. The story does mention some of the potential harms of uterine artery embolization, such as the need for repeat procedures for treatment of recurrent symptoms and the fact that there are questions about safety of pregnancy after the procedure. The story should have also mentioned the potential for ovarian failure, causing infertility, infection, delayed complications and a small risk of emergency hysterectomy. The story adequately describes the design of the current study. The story accurately describes the prevalence and symptoms of uterine fibroids. The story only uses quotes from the original article and accompanying editorial. It doesn't appear that the authors were even interviewed. The story should have quoted other clinicians/researchers who were not related to the study who could have provided some perspective on what this new information means for clinical practice. The story does mention alternative options such as myomectomy (surgical removal of the fibroids), hysterectomy (surgical removal of the uterus) in addition to uterine artery embolization. The story could have mentioned other treatments such as watchful waiting, pain medications or birth control pills. The story does not state whether uterine artery embolization (UAE) is available and if so, how widely. And availability is a real issue. It requires expertise in interventional vascular radiology and an interest in the female pelvic anatomy. Facilities offering the procedure would need strong links between gynecologists and radiologists to provide coordinated assessment and care. This is not explained in the piece. The story implies that uterine artery embolization is a new procedure. The story could have mentioned that the procedure has been performed for more than 10 years in Europe and the US, although it has been limited to mostly academic hospitals. There is no way to know if the story relied on a press release as the sole source of information, although it is noteworthy that the story only uses quotes lifted from the published study and from an accompanying editorial. It doesn't appear that these people were actually interviewed.

A: Treating fibroids without surgery
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Q: The company said the trial will continue unchanged as per the recommendation of a data monitoring committee. The trial was testing Bristol-Myers’ drugs Opdivo and Yervoy, against Opdivo alone, in patients with advanced melanoma. The combination failed to show a statistically significant benefit in patients whose tumors had 1% or lower levels of the PD-L1 protein being targeted, the company said. The American Cancer Society estimates that about 96,480 melanoma cases will be diagnosed in the United States this year. Bristol-Myers shares were trading at $55.99 before the bell.

A: Bristol-Myers misses main goal of late-stage skin cancer trial.
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Q: The U.S. Food & Drug Administration (FDA) rejected Lemtrada for launch in the world’s biggest drug market on the grounds that Genzyme had not shown its benefits outweighed its “serious adverse effects”, Sanofi said on Monday. The FDA also demanded Sanofi carry out further clinical trials using different designs and methods prior to approval, Sanofi said. The company said it strongly disagreed with the decision and planned to appeal. The FDA ruling could impact the value of Sanofi’s Genzyme takeover, since the latter’s shareholders had received so-called contingent value rights (CVRs) entitling them to future payments of up to $14 a share if certain goals were met. The CVRs, which are traded in the United States under their own stock market quote, slumped 63 percent to an all-time low of 30 cents. They were worth $2.10 in October, but tumbled the following month after a review by an advisory panel to the FDA raised questions over the design of the clinical trial and Lemtrada’s potential to cause cancer and other conditions. Shares in Sanofi were down 0.9 percent at 75.88 euros at 1522 GMT, the biggest losers in a flat CAC 40. Germany’s Bayer, which has an option to co-promote Lemtrada in the United States, saw its shares fall 1 percent. Sanofi said on Monday it did not expect to meet the CVR milestone of U.S. approval for Lemtrada by the end of March. Other milestones are related to the drug’s sales and would likely be hard to reach without the U.S. market. Analysts on average had expected Lemtrada to generate annual sales of $707 million by 2018, according to forecasts compiled by Thomson Reuters. “Genzyme’s takeover was about catching up in biologics, having a greater footprint in the United States, and also largely for Lemtrada,” said Eric Le Berrigaud, analyst at Bryan Garnier & Co. “This is unquestionably a setback, as without a U.S. market such a product doesn’t have the same potential.”  The brokerage, which had forecast peak Lemtrada sales of $400 million in the United States, said it was scrapping the U.S. market from its forecasts. It argued it would take Sanofi at least three years to conduct the studies demanded by the FDA, and that, given an increasingly crowded market for MS drugs, it could opt out of what could be a lengthy and costly process. But Renaud Murail, a fund manager at Barclays Bourse, said Monday’s development was no big surprise for investors who had already factored in the risk of U.S. rejection. “Genzyme remains Sanofi’s gem and this is only a half-defeat,” he said. A U.S. law firm acting on behalf of purchasers of the CVRs has launched a class action alleging Sanofi misled investors over Lemtrada’s efficacy, safety and prospects. A Sanofi spokesman said it was reviewing the FDA letter and evaluating its next steps, including the appeal timeline. Genzyme chief David Meeker said: “We strongly believe that the clinical development program, which was designed to demonstrate how Lemtrada compares against an active comparator as opposed to placebo, provides robust evidence of efficacy and a favorable benefit-risk profile.”  Lemtrada is designed to treat relapsing remitting multiple sclerosis, the most common form of the disease. It was approved in September by European regulators in a market dominated by rivals Biogen Idec, Novartis and Teva Pharmaceutical Industries. Multiple sclerosis is a chronic, autoimmune condition which affects more than 2 million people worldwide and up to 500,000 in the U.S. It attacks the central nervous system and can cause muscle weakness, pain and cognitive difficulties. Lemtrada is given via an intravenous drip and designed to reprogram the immune system, but can make the body more vulnerable to other diseases. The multiple sclerosis market is increasingly moving away from injectable treatments in favor of pills such as Novartis’ Gilenya and Biogen Idec’s Tecfidera. Some analysts expect that Lemtrada, partly handicapped by its risk profile and injectable form, will be reserved for patients for whom other treatments are ineffective. Sanofi also has an oral treatment, Aubagio, developed by Genzyme and which has already been approved in the U.S. and Europe. Analysts on average expect Aubagio sales to reach $854 million by 2018, according to Thomson Reuters data. ($1 = 0.7258 euros)

A:
Sanofi MS drug suffers setback in key U.S. market.
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