Where have all the triplets (and quadruplets, and quintuplets) gone?

first_img About the Author Reprints By Jennifer Adaeze Okwerekwu April 28, 2016 Reprints That curve mirrors a trend in reproductive technology. The rise in higher-order multiples peaked in 1998 when implanting four or more embryos was a common practice. As various parts of IVF improved through the latter part of the 20th century, these implantation rates were increasingly driving multiple births.Vitrification, or flash freezing, began allowing doctors to freeze and thaw embryos at a survival rate of nearly 100 percent. This meant all the embryos do not need to be used at once. Doctors also developed better means of screening embryos before they were implanted, what’s called preimplantation genetic screening. “We have learned that most embryos that don’t stick, don’t stick because the embryos themselves were not normal,” said Grunfeld.As a result, in 1998 the American Society for Reproductive Medicine (ASRM) and the Society for Assisted Reproductive Technology (SART) introduced guidelines to encourage doctors to implant fewer embryos, and those have been continually revised downward since then. On top of that, doctors have felt a professional pressure to be conservative in their practice. “Even staying within the guidelines there is a concern about multiple birth … so there has been an incredibly big push over the past two or three years to put in only one embryo at a time,” said Grunfeld. Desi Fortin is an increasingly rare type of mother: a mother of triplets.After a steep rise in the 1980s and ’90s, the number of women giving birth to three or more babies is about half of what it was at its peak. The reason, scientists say, for both the rise and the fall of these multiple births is changing practices in assisted reproduction.Fortin, 30, gave birth to identical boys and a girl in August 2015 after struggling for years with infertility. When she and her husband decided to have in vitro fertilization, they chose to implant two embryos in hopes of having at least one baby.advertisement Just two decades ago, a woman Fortin’s age would commonly have had twice as many embryos implanted. “The reason [doctors] put in many embryos is that we weren’t sure which were the good ones,” said Dr. Lawrence Grunfeld, associate clinical professor of obstetrics, gynecology, and reproductive science at Mount Sinai Hospital.But, probably partly thanks to improvements in IVF, both of Fortin’s embryos implanted — and one divided to form identical twins.advertisement Columnist, Off the Charts Jennifer Adaeze Okwerekwu is a psychiatrist and a columnist for STAT. HealthWhere have all the triplets (and quadruplets, and quintuplets) gone? Data released Thursday by the US Centers for Disease Control and Prevention show that the rate of triplet and higher-order births dropped 60 percent for women over the age of 25 from 1998 to 2014. The biggest decline was in women 45 and older, where the rate of these births is just a third of what it once was. The rates did not change significantly for women under the age of 25. Related: Related:center_img Do antidepressants during pregnancy increase baby’s autism risk? R. Viner/Daily Express/Getty Images @JenniferAdaeze Jennifer Adaeze Okwerekwu Tags IVFpregnancytriplets Some fertility treatments produce more boy babies. Here’s why The drop in triplets, quadruplets, and others is welcomed by doctors. Pregnancies of multiple babies have an increased risk of complications. According to ASRM and SART, the goal of assisted reproduction is to achieve a singleton birth.“Infants born in triplet deliveries are at high risk of poor outcomes,” said Joyce A. Martin, the lead author of the CDC’s new analysis. “So a decline in these deliveries is a positive for infant health overall and for public health overall.”It is possible to reduce the number of fetuses in a multifetal pregnancy, but the procedure has some risks and may carry significant psychological consequences for families struggling with infertility.Guidelines based on the patient’s age and health history help doctors and their patients decide exactly how many embryos to implant. No more than five embryos may ever be implanted at a time, and facilities that consistently have higher-order births may be audited by SART.“We all know the story of the ‘Octomom’ where the physician actually adhered to a patient’s request to put in eight embryos and she got the eight babies,” said Grunfeld. “That was considered medical malpractice.”The guidelines stipulate that healthy patients under the age of 35 should be offered a single-embryo transfer and no more than two embryos. If the patient elects to transfer two embryos, they must be counseled on the risk of a multifetal pregnancy.This is what happened to Desi and her husband, Ryan Fortin, when they decided to implant two embryos. Their physician encouraged them to implant one embryo, but after two years of trying to conceive, “we had a hard time doing one because we were worried that it was not going to take. After going through what we went through emotionally and my body physically, it would have been devastating just putting one embryo back and having it not take.”Desi and Ryan Fortin with their triplets in December 2015. Courtesy Desi FortinIn the course of blogging about her experience with infertility, Desi found a community that shared their experiences with IVF. Some families she knew transferred two embryos and got one baby, others got two, others implanted one and got none, she said.Both of Desi’s embryos successfully implanted. During her first ultrasound, she and Ryan discovered that one of the embryos had split and they were expecting triplets. At 34 weeks she delivered Charlize and her younger twin brothers Sawyer and Jax by caesarean section.Still, even knowing her one baby might turn into three, Desi said that she would make the same decision again today. “You need to take in what the doctors are telling you, take in the advice and listen, and just go with what is best for you,” she said. [email protected] last_img read more

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Behind the Sarepta drug approval was intense FDA bickering

first_img Ed Silverman Leave this field empty if you’re human: According to the memos, Woodcock acknowledged some issues with trial data submitted by the company to win approval, but she disagreed with Unger and other FDA staff about the extent to which boys treated with the medicine would experience a meaningful clinical benefit.Their disagreement, however, also reflected a more fundamental debate over the stance the agency should take toward the Sarepta drug. Until now, the FDA had not approved a drug to treat Duchenne, prompting parents and some lawmakers to argue for accelerated approval, a process that relies on surrogate endpoints instead of actual medical benefits to endorse a drug.This has been a highly charged issue and has transformed the Sarepta drug into a litmus test for agency approval of new medicines, notably for diseases with unmet medical needs. Seen through that prism, Unger maintained that approving the drug would be detrimental to the FDA approval process on a long-term basis. Privacy Policy “By allowing the marketing of an ineffective drug, essentially a scientifically elegant placebo, thousands of patients and their families would be given false hope in exchange for hardship and risk,” he wrote in a July 18 dispute report. “I argue that this would be unethical and counterproductive. There could also be significant and unjustified financial costs — if not to patients, to society.”He added that approval “would send the signal that political pressure and even intimidation — not science — guide FDA decisions… A standard this low would undercut FDA’s ability to ensure that drugs that are approved are effective; it would call into question much of what we do. Lowering the bar to this level would be tantamount to rolling back the 1962 Kefauver-Harris Drug Amendments to the Federal Food, Drug and Cosmetic (FD&C) Act, which have served Americans well for some 54 years.”According to Borio, both Unger and the members of the FDA review team told the dispute review board that Woodcock “seemed focused on the external pressures, from both patient advocacy groups and Congress, and that she frequently talked about the effects of a decision regarding eteplirsen in terms of overarching policy.”Ultimately, the review board found that “Woodcock’s extensive, early involvement in the review process troubling. Indeed, her involvement here appears to have upended the typical review and decision-making process. Rather than ensuring that the scientific reviews started at the bottom of the chain of command, Woodcock made clear from her position at the top that she was pushing for a particular outcome from the very early stages.” @Pharmalot Related: PharmalotBehind the Sarepta drug approval was intense FDA bickering By Ed Silverman Sept. 19, 2016 Reprints [email protected] Please enter a valid email address. Privacy Policy About the Author Reprints Did the FDA set ‘a dangerous precedent’ with its latest drug approval? The run-up to Monday’s approval of a Sarepta Therapeutics drug to treat Duchenne muscular dystrophy was marked by unusual bickering inside the Food and Drug Administration, where debate over a key scientific question morphed into a formal dispute, and the head of the drug review division was accused of being too intensely involved in the process for evaluating the medicine.Ultimately, the decision to greenlight the drug fell to the FDA Commissioner, Dr. Robert Califf. In a 13-page memo last Friday, he deferred to Dr. Janet Woodcock, the controversial head of the drug review division, who pushed hard to approve the Sarepta medication but clashed with other FDA officials along the way.“The science is not in dispute beyond the usual types of disagreement that occur when experts review clinical evidence from different perspectives,” he wrote. “It is clear that Dr. Woodcock’s decision utilized the flexibility afforded under the relevant statutory provisions, including consideration of the life-threatening decisions of the disease and the lack of alternative treatments.”advertisement Leave this field empty if you’re human: Newsletters Sign up for D.C. Diagnosis An insider’s guide to the politics and policies of health care. Tags duchenne muscular dystrophyFDAJanet WoodcockpolicySarepta Therapeutics FDA approves Sarepta’s controversial drug for Duchenne muscular dystrophy Related: Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Please enter a valid email address. Califf was compelled to chronicle his decision in response to a formal dispute that was filed by Dr. Ellis Unger, who reports to Woodcock, and disagreed with her decision to approve the drug and the way she went about advocating for approval. The Califf memo was one of several internal FDA documents involving the dispute and the fate of the Sarepta drug that were released Monday.There is frequently disagreement among FDA staff over the extent to which clinical trial data should support the approval of a new medicine. But the intensity of the dispute surrounding the Sarepta drug underscores the stakes that were involved in this episode. Beyond this one drug, the discord among FDA officials illuminated a wider debate about the pressures the agency faces to endorse medicines from an increasingly aggressive patient population.advertisement Newsletters Sign up for Pharmalot Your daily update on the drug industry. In the approval of Sarepta’s drug, the FDA’s commissioner, Dr. Robert Califf, deferred to the controversial head of the agency’s drug review division. Andrew Harnik/AP In his dispute, Unger identified four deviations from the usual typical decision-making process. He claimed Woodcock was involved in the early stages of the review; she had “extensive involvement” in planning and participating in an expert panel meeting last spring; she made an initial decision last May to approve the drug before the FDA review team completed a draft review memo; and she issued a final decision memo before Unger finalized his own memo.Unger was not alone. In an Aug. 8 memo to Califf, Dr. Luciana Borio, the FDA acting chief scientist who convened the board that reviewed the dispute, wrote that “we fear that those actions could have chilled scientific debate within (the FDA Center for Drug Evaluation and Review) and reduced the level of participation by the review team during the final stages of the decision-making process.”“Rather than ensuring that the scientific reviews started at the bottom of the chain of command, Dr. Woodcock made clear from her position at the top that she was pushing for a particular outcome from the very early stages,” Borio wrote. And she noted that at least two staffers were leaving or were about to leave in response to the decision-making process “and the pressures exerted by outside forces.”Indeed, the dispute centered primarily on a disagreement over whether the Sarepta drug, known as eteplirsen, would produce enough of a protein called dystrophin to generate a clinically meaningful benefit. Boys suffering from Duchenne have a mutation and lack the protein. Sarepta argued that a very small clinical trial demonstrated the drug helped enough boys based on various measures, including a six-minute walking test.last_img read more

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Anger at EpiPen prices channeled at Mylan CEO in congressional hearing

first_img Talia Bronshtein/STAT Source: Elsevier Clinical Solutions’ Gold Standard Drug Database Others pushed Bresch on the numbers she provided. Buddy Carter (R-Ga.) wanted to know exactly where the money flows in the supply chain, like how much money Mylan pays to the pharmacy benefit managers. Bresch said she didn’t have that information with her and said she would provide it within 10 days.At the hearing, Bresch presented a table to show that Mylan makes a profit of $50 per EpiPen, with costs like “Cost of Goods Sold” and “Direct EpiPen Auto-Injector Costs.” Bresch said at the hearing that the direct costs included costs related to sales, marketing, disease awareness programs, and programs to provide access to EpiPens, but not research and development — a Mylan spokesperson later clarified that it did include R&D directly related to EpiPens.“We would expect a very professional presentation on your [profit and loss statement], and these dumbed-down versions do not make sense without the definitions in here,” Chaffetz said, waving around a piece of paper with the table printed on it. “It just feels like you are not being candid and honest with Congress.”Chaffetz called for more competition in the market, saying that this would help drive down the price. However, the availability of alternatives may not be enough — the introduction of Auvi-Q in 2013 did not lead to lower prices. How does the EpiPen work?Volume 90%Press shift question mark to access a list of keyboard shortcutsKeyboard ShortcutsEnabledDisabledPlay/PauseSPACEIncrease Volume↑Decrease Volume↓Seek Forward→Seek Backward←Captions On/OffcFullscreen/Exit FullscreenfMute/UnmutemSeek %0-9 facebook twitter Email Linkhttps://www.statnews.com/2016/09/21/mylan-ceo-congress/?jwsource=clCopied EmbedCopiedLive00:0001:5201:52  Alex Hogan, Hyacinth Epinado/STAT Alex Hogan, Hyacinth Epinado/STAT Hauling pharmaceutical executives before congressional committees to testify about increasing prices has become somewhat of a ritual.Cummings reprimanded Martin Shkreli before the very same committee in February — but Shkreli said little, pleading the Fifth Amendment. The CEO of Valeant Pharmaceuticals admitted it was a mistake to so aggressively raise prices to the Senate Special Committee on Aging in April. BusinessAnger at EpiPen prices channeled at Mylan CEO in congressional hearing By Ike Swetlitz Sept. 21, 2016 Reprints At a four-hour congressional hearing about EpiPen prices on Wednesday representatives excoriated the CEO of Mylan, Heather Bresch, taking the opportunity to call her to task on questions the company has so far successfully dodged.“This hearing is critical because yet another drug company, Mylan, has jacked up the price of a lifesaving product for no discernible reason — and I did read your testimony, Ms. Bresch, and I was not impressed,” Rep. Elijah Cummings said in his opening remarks. “The reason being, I believe, is to get filthy rich at the expense of our constituents.”Bresch in her testimony focused on the efforts the company has made to increase availability of the devices, but did not give a reason for the increase in price.advertisement The EpiPen was her ‘baby.’ Now this pharma CEO is in the hot seat over price hikes Tags EpiPenMylan Mylan may have violated antitrust law in its EpiPen sales to schools, legal experts say After Mylan acquired the rights to market the EpiPen in the United States, the company led a legislative campaign to get laws passed all over the country that enabled or required schools to keep epinephrine auto-injectors in stock. During some of that time, Bresch’s mother, Gayle Manchin, was president of the National Association of State Boards of Education, and she used that position to further Mylan’s legislative agenda, a USA Today investigation found.At the hearing, Bresch said the USA Today article “is completely inaccurate.”Mylan provided hundreds of thousands of EpiPens to schools for free, and also offered them at a discounted cost. The forms that some schools signed to order these discounted EpiPens included the provision that the schools would not buy competitive products. The New York attorney general is investigating Mylan for antitrust violations. Mylan has said that this exclusivity agreement is no longer part of their program.Rising deductibles have made the price increases even more painful for individuals, who end up paying more out-of-pocket before their insurance kicks in. In light of media attention, congressional scrutiny, and investigations by attorneys general, Mylan has taken some steps to quell public anger, by making EpiPens available for free for families of four making under $98,000 and increasing the amount of a coupon that lowers costs for individuals with certain types of insurance plans. The outrage is driven by the increasing price of EpiPens, and the growing perception that Mylan has been using its monopoly position to drive up prices and drive out competition. A two-pack currently lists for about $608, which is over 450 percent higher than the price was in 2004. There are no generics currently available, and EpiPens made up 89 percent of the epinephrine auto-injector market last year, according to data from IMS Health.advertisement The House Committee on Oversight and Government Reform convened the hearing to address the “justified outrage from families and schools across the country struggling to afford the high cost of EpiPens,” according to a joint statement by the committee’s chairman Jason Chaffetz (R-Utah) and ranking member Cummings (D-Md.). The rising cost of EpiPens050100150200250300350EpiPen inflation-adjusted (2016) list priceper 2-Pak in US dollarsDateEpiPen priceMay 16, 2016$304.31Nov 23, 2015$268.9May 1, 2015$234.03Nov 5, 2014$203.92May 2, 2014$177.47Nov 8, 2013$156.97Jul 17, 2013$136.62Nov 7, 2012$126.12Jul 27, 2012$114.76Mar 6, 2012$104.42Oct 18, 2011$96.98May 12, 2011$88.25Dec 15, 2010$82.84Aug 3, 2010$75.38Oct 12, 2009$69.71Jan 14, 2009$58.05Jan 16, 2008$55.09Feb 22, 2007$54.48Feb 23, 2006$53.88Feb 23, 2005$53.48Nov 1, 2004$53.16The rising cost of EpiPens Related: Related: STAT Cummings said he is concerned that the hearing won’t lead to any real change, and that Mylan would just roll with the punches and go back to business as usual.“After Mylan takes our punches, they’ll fly back to their mansion in their private jets and laugh all the way to the bank while our constituents suffer, file for bankruptcy, and watch their children get sicker or die,” Cummings said.Some members of Congress didn’t even take the time to ask questions, opting instead to fill up their five minute allotments with a public shaming of the company.last_img read more

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Pharmalot, Pharmalittle: Battle over California’s Prop 61 for lower drug prices is tightening

first_img Ed Silverman About the Author Reprints Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. [email protected] Johnson & Johnson wants to have lawsuits claiming its talcum powder caused women to develop ovarian cancer moved to a different court, Reuters reports. The health care giant is attempting this gambit after losing a $67.5 million jury verdict last month, which marked its third straight trial defeat. All three awards, totaling around $195 million, were handed down in state court in St. Louis, with the same judge presiding.Two Pakistani nationals held in custody since their 2012 arrest have been sentenced to time served for operating websites from 2005 to 2012 that illegally shipped $2 million of pharmaceuticals from Pakistan and the United Kingdom to other countries, according to federal prosecutors.advertisement Good morning, everyone, and welcome to another working week. And this should be an exciting one, yes? After all, there is an election taking place and who knows what may happen. All the more reason to start quaffing cups of stimulation to prepare for whatever lies ahead. On that note, we also offer you some tidbits. Hope you have a productive day and please keep us in mind when something intriguing occurs. We accept secret documents, you know …The battle over Prop 61 — the California ballot measure aimed at lowering drug prices — looks to be tightening, Reuters reports. The measure would require state agencies to pay the same as the Department of Veterans Affairs. A survey of nearly 1,500 registered voters at the end of October found 47 percent of voters would vote yes and 47 percent would vote no. The pharmaceutical industry donated $109 million to fight the effort.New data-driven pricing plans drug makers are trying to replace the “pay-per-pill” approach are increasingly used for cancer treatments but will take longer for other conditions, such as multiple sclerosis, Jens Grueger, who heads global pricing and market access at Roche, tells Reuters. “At this point in time, we don’t see a way that it would practically work. The data are not available, but it would be very much in line with our pricing philosophy.”advertisement Tags Californiadrug pricesJohnson & Johnsoncenter_img By Ed Silverman Nov. 7, 2016 Reprints @Pharmalot Alex Hogan/STAT The UK’s Medicines and Healthcare products Regulatory Agency has launched a social media campaign to raise awareness of side effects and improve the public’s understanding of how to report them, PMLive says.Cancer Research UK is partnering with the Wellcome Trust, Syncona, and BACIT to create a new public company with assets up to $1.2 billion to invest in life sciences, PharmaTimes tells us.Roche is pursuing two skin cancer trials that combine its Tecentriq immunotherapy and other drugs after early data showed the treatments were well-tolerated and effective in a small number of patients, Reuters says.Merck KGaA employees in Pakistan protested at the German embassy in hopes of receiving severance payments they argue are due after the drug maker sold a majority stake in its operations in the country, Dawn reports.India and the UK signed memoranda of understanding on intellectual property rights that envisions establishing a mechanism for promoting cooperation between intellectual property offices, the Economic Times says. PharmalotPharmalot, Pharmalittle: Battle over California’s Prop 61 for lower drug prices is tightening last_img read more

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EPA nominee Scott Pruitt was hammered for his answer on lead poisoning. But he has a good point

first_img STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Politics Tags Congresspediatricspolicypublic health GET STARTED By Rebecca Robbins Jan. 18, 2017 Reprints Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. EPA nominee Scott Pruitt was hammered for his answer on lead poisoning. But he has a good point What is it? Log In | Learn More What’s included? Scott Pruitt, nominated to head the EPA in the Trump administration, at his confirmation hearing. Aaron P. Bernstein/Getty Images Scott Pruitt, the Oklahoma attorney general picked by President-elect Donald Trump to lead the Environmental Protection Agency, immediately drew blowback during his confirmation hearing on Wednesday for saying that he “hasn’t looked into the scientific research” on precisely how much lead exposure is unsafe for children.Critics slammed Pruitt’s response as an uninformed and dangerously naive perspective on a critical environmental health issue. But, in fact, Pruitt’s not alone in his uncertainty on this question. There’s an ongoing debate among scientists and regulators about how much lead is too much for kids to have in their bodies. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTEDlast_img read more

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Scientists have created a ‘sunless tanner’ drug that boosts melanin in skin

first_img About the Author Reprints Megan Thielking @meggophone Scientists hoping to harness melanin’s protective power against skin cancer have created a class of small molecules that could help the skin produce more UV-absorbing pigments. They tested those treatments on human skin samples in the lab, and found they were able to seep in and boost pigment production.STAT chatted with study author and cancer researcher Dr. David Fisher about the work, published in Cell Reports.What did you set out to study?We know a lot about how pigmentation is made, so we looked for a way to find a small molecule chemical to stimulate pigmentation. We wanted to know whether it would be possible to activate real skin pigmentation without using radiation or the sun’s rays, which are damaging and dangerous. We discovered a class of compounds that have the ability to penetrate into the skin and trigger pigmentation.advertisement Lab ChatScientists have created a ‘sunless tanner’ drug that boosts melanin in skin What do you see as the potential applications for those compounds?We think it could offer protection. Having dark skin is associated with a really dramatically lower risk of developing skin cancer. Even individuals with just modestly darker skin have a significantly lower skin cancer risk than fair-skinned people who don’t tan, but burn. We don’t anticipate that a huge degree of darkening would be required for the protection. I’m seeing this from a cancer prevention perspective as something that would be used together with sunscreen. I would not see it as a replacement for sunscreen, because sunscreens really do prevent skin cancer.A photograph of skin treated with a topical drug that induces pigmentation. Nisma Mujahid and David E. FisherWhat’s the next step in the research?The safety would need to be established and tested. I think probably where it would be tested first would be in individuals who are at the highest risk for developing skin cancer. Drew Angerer/Getty Images Tags cancerresearch [email protected] By Megan Thielking June 14, 2017 Reprints News Editorlast_img read more

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Cleveland Clinic and American Cancer Society move fundraisers from Mar-a-Lago

first_imgHospitalsCleveland Clinic and American Cancer Society move fundraisers from Mar-a-Lago By Casey Ross Aug. 17, 2017 Reprints Trending Now: Mar-a-Lago has hosted eight years’ worth of Cleveland Clinic fundraisers. ON EMMERT/AFP/Getty Images About the Author Reprints @caseymross CLEVELAND — The Cleveland Clinic and the American Cancer Society said they will not hold annual fundraising galas at President Trump’s Mar-a-Lago resort in Florida amid intense criticism over the president’s reluctance to denounce white nationalist groups.The announcements come as businesses have faced increasing pressure to distance themselves from Trump, who has been sharply criticized for his equivocal response to the deadly violence in Charlottesville, Va. The clinic’s decision, which was announced Thursday, was a reversal from its prior commitment to keep the event.Its announcement was quickly followed by the American Cancer Society, which also said it would drop plans to hold its 2018 gala at Mar-a-Lago.advertisement The clinic has held a fundraiser at the Mar-a-Lago club for the past eight years. This year’s event happened soon after Trump’s January executive order on immigration, which prevented a Cleveland Clinic doctor from returning to the country, prompting protests and calls for the February fundraiser to be moved or canceled. But the fundraiser went on as planned, attracting about 500 attendees and raising $1 million for the clinic’s Florida hospital.The clinic initially said it planned to again hold its event at the resort in 2018. On Thursday, executives reversed course, but avoided any mention of politics in their justification. “After careful consideration, Cleveland Clinic has decided that it will not hold a Florida fundraiser at Mar-a-Lago in 2018,” a hospital spokeswoman said in a statement. “We thank the staff of Mar-a-Lago for their service over the years.” “Our values and commitment to diversity are critical as we work to address the impact of cancer in every community,” the cancer organization said in a statement. “It has become increasingly clear that the challenge to those values is outweighing other business considerations.”The news of the canceled events followed a decision by prominent business executives on Wednesday to disband a business advisory council advising the president. The clinic’s CEO, Dr. Toby Cosgrove, was among the executives who opted to pull the plug on the council.advertisement National Technology Correspondent Casey covers the use of artificial intelligence in medicine and its underlying questions of safety, fairness, and privacy. He is the co-author of the newsletter STAT Health Tech. Casey Ross [email protected] Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson last_img read more

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Grassley joins the debate over drug discounts with bill pushing hospitals to disclose payments

first_img STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Sen. Chuck Grassley (R-Iowa) Alex Wong/Getty Images Log In | Learn More Politics Erin Mershon [email protected] By Erin Mershon March 1, 2018 Reprints Senior News Editor @eemershon Unlock this article — plus daily intelligence on Capitol Hill and the life sciences industry — by subscribing to STAT+. First 30 days free. GET STARTEDcenter_img What is it? Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. WASHINGTON — A senior Republican senator is wading into the debate over a controversial drug discount program with new legislation to require more transparency from hospitals that participate.Sen. Chuck Grassley (R-Iowa) dropped legislation Thursday that takes aim at the so-called 340B program, which forces drug companies to give some public and nonprofit hospitals discounts on medicines. Through Medicare, the federal government then reimburses the facilities for the drugs at a higher rate. About the Author Reprints GET STARTED Tags Congressdrug pricinghospitalsMedicarepolicypoliticsSTAT+ What’s included? Grassley joins the debate over drug discounts with bill pushing hospitals to disclose payments last_img read more

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What my kidney cancer is teaching me about serendipity and persistence

first_img During the height of World War II, an artillery shell fired by German forces landed 10 feet from my grandfather. It didn’t explode. Before he died last year, he would take stock at family gatherings and marvel, “Look at all that was possible because that shell didn’t go off.”I’ve recently learned that sometimes the shell actually does explode. Earlier this year, I was diagnosed at the age of 33 with an aggressive form of kidney cancer. The diagnosis came suddenly after excruciating back pain and seeing blood in my urine led me to have a CT scan one Friday afternoon. It was only in hindsight that I appreciated the significance of the last month’s unexplained weight loss and night sweats.Of the many things going through my mind on the night of the diagnosis, the one that kept rising to the top was, “This was not supposed to happen to me.” I know that people are told every day they have cancer. As a doctor, I’ve seen this scenario unfold before my eyes — but to other people.advertisement When I was in medical school, I remember being shocked that even in healthy young bodies, some cells are naturally predisposed to mutate and develop into cancer. Fortunately, they are generally held back by a multitude of protective mechanisms. Back then, I wondered with naïve curiosity how it was possible that most of us didn’t have cancer when all it takes is a couple of faulty tumor suppressor genes or a mutated proto-oncogene. About the Author Reprints It occurs to me now that those words mirrored the actions of my cancer cells. It takes a certain tragic serendipity for cancer to exist, but its persistence is what makes it blossom into a life-threatening illness.My cancer cells — like all cancer cells — are programmed to survive and grow. Through no fault of their own, they have genes that help them divide faster than neighboring kidney cells and stave off death, even in the low-oxygen environment of a kidney tumor that other cells simply can’t bear. Cells from many different kinds of tumors, including my own, even develop a “do not disturb” signal, a protein called programmed cell death ligand-1 (PD-L1), to hold off the immune system, not because they are clever but because the ones that didn’t survive were probably killed off by the immune system.If the primary tumor in my kidney had the chance to shoot off cells to colonize my lungs or liver or bones before it was cut out of me, it wasn’t because it was following some faulty code of ethics aimed at killing its host — me — but because of an insuppressible drive to survive in spite of many other signals telling it to die off.After my diagnosis, I, too, shifted into survival mode. As an assistant professor at Harvard Medical School and a psychiatrist at Beth Israel Deaconess Medical Center, I had the advantage of working in a world-class institution and down the street from one of the premier cancer centers in the world —the Dana-Farber Cancer Institute. The director of my center at Beth Israel Deaconess knew another faculty member who had been diagnosed with kidney cancer, and pointed me toward a magnificent team of oncology and surgery specialists at Dana-Farber and Brigham and Women’s Hospital.The necessary short-term actions were quickly outlined by my expert medical team — Dr. Toni Choueiri, nurse practitioner Ally Mulloy, and Dr. Steven Chang. Within seven days, the tumor, along with the rest of my left kidney, had been removed. Because my cancer had a high likelihood of recurring, I started an experimental immunotherapy regimen aimed at preventing that from happening. Newsletters Sign up for Cancer Briefing A weekly look at the latest in cancer research, treatment, and patient care. [email protected] Privacy Policy I returned to an eerie simulation of my old life. It seemed like I was the only one who could tell that everything had changed, and it made me uneasy — but also motivated — to have such an altered viewpoint. I decided that, if for no other reason than my own mental well-being, the status quo wasn’t going to suffice. I wanted to do more, not just for myself but for my 2-year-old son who has a father — and three other relatives — who have been diagnosed with kidney cancer. What I yearn for more strongly than watching with my wife as he grows up is to know that he won’t have to face this disease as I have.I began to write about my experience as a young physician living with cancer in medical journals and other platforms. Writing gave me an outlet for coping, and also helped me give voice to others experiencing the same struggle.About a month after my diagnosis, I connected with Dena Battle, who had read one of my essays. She had lost her husband to kidney cancer a few years before. Needing to do more, she started using the skills she had developed as a legislative director and policy lobbyist in Washington, D.C., and created the Kidney Cancer Research Alliance (KCCure), a grassroots organization of patients, caregivers, doctors, and medical researchers dedicated to accelerating research toward a cure. I decided to help out with the organization’s fundraising efforts.Last year, KCCure awarded its first-ever innovation award to Dr. Wayne Marasco, a Dana-Farber researcher. His lab is attempting to discover and operationalize immunotherapy against multiple cancers, including kidney cancer. Knowing that the lab was just up the street from where I work, Dena arranged for me to meet with Marasco and his team to discuss their progress.In that meeting, I learned that the Marasco lab’s approach taps into the strength of patients’ immune cells. They are engineered in the lab to be CAR-T cells, great numbers of which are generated and infused back into the patient. They attack only those cells that carry antigens unique to the cancer. Similar approaches are already being used against blood cancers with great success, but using CAR T-cell therapy in solid tumors has been elusive because the tumor microenvironment suppresses the activity of immune cells. By Adam Philip Stern Dec. 19, 2018 Reprints Related: Please enter a valid email address. Cemetery walks and playwriting: How I found healing after breast cancer Leave this field empty if you’re human: But I slept fine at night for 10 years, knowing that I was, indeed, young and healthy, and that while I might not understand how or why bodies worked that way, they worked — until I was standing in the foyer of our home hugging my wife, whispering that somehow we were going to get through this together simply because we had to.advertisement Related: First OpinionWhat my kidney cancer is teaching me about serendipity and persistence New immunotherapy techniques, such as checkpoint inhibition, may allow this technique to be extended to solid tumors like those found in kidney cancer. Based on promising animal work, Marasco and his colleagues hope to launch clinical trials in humans in the near future.What I didn’t know when I set up the meeting with Marasco was that his life course was also irreparably altered by kidney cancer. About 15 years ago, he told me, his family was in Hawaii celebrating his daughter’s completion of chemotherapy for leukemia. For fun, he went on a run up and down a volcano. It was a vigorous workout that put just enough pressure on his kidneys to produce the first visible symptoms of disease — blood in the urine. That run was fortuitous because it detected his kidney cancer early. While in his hospital room recovering from surgery, Marasco began working on his first immunotherapy research grant proposal for kidney cancer.When I think about all of the circumstances that had to go just right for me to be born and just wrong for me to be diagnosed with kidney cancer, I realize there is so much serendipity in this world that it cannot be understood or predicted. The same universal chaos that caused an artillery shell not to explode 75 years ago — allowing me to exist at all — also led to my diagnosis. It’s the same mysterious force that connected me to a stranger a thousand miles away with a foundation that sent me to meet one of the scientists working to find a cure for kidney cancer just down the street, who had his own serendipitous route to studying it.I cannot possibly predict what comes next for me or the millions of other people with cancer trying to survive right now. What I do know is that I will contribute however I can to fighting kidney cancer and that, like the cells that threaten my life, I will persist.Adam Philip Stern, M.D., is the director of psychiatric applications at the Berenson-Allen Center for Noninvasive Brain Stimulation at Beth Israel Deaconess Medical Center and an assistant professor of psychiatry at Harvard Medical School. Tags cancerphysicians Watch: CAR-T is a personalized attack on cancer. Here’s how it works Adam Philip Stern @adamphilipstern Kidney cancer cells Paul Andrews/Univ. Dundee/Wellcome Collectionlast_img read more

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PhRMA blasts Trump’s plan to tie U.S. drug prices to other countries’ — but some of its criticisms don’t hold up

first_imgPolitics STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. PhRMA blasts Trump’s plan to tie U.S. drug prices to other countries’ — but some of its criticisms don’t hold up Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED What’s included? Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Log In | Learn More By Ike Swetlitz Jan. 24, 2019 Reprints GET STARTED WASHINGTON — The pharmaceutical industry’s Washington lobbying group is fighting full force to scuttle a Trump administration policy proposal that would tie the price of drugs in the U.S. to their costs abroad — and making a handful of specious arguments along the way, health policy experts told STAT.PhRMA has launched a multipronged attack against the proposal, arguing that it would, in effect, make health care in America more closely resemble systems in Europe. Patients wouldn’t be able to get as many new drugs and might suffer as a result, they say. Drugs displayed at a pharmacy in Paris. STEPHANE DE SAKUTIN/AFP/Getty Images What is it? Tags drug pricinggovernment agenciespolicySTAT+White Houselast_img read more

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