From FDA expert to biotech insider: The drug industry thrives on the revolving door

first_imgLeave this field empty if you’re human: “There haven’t been many quantitative studies on the revolving door at the FDA, so we didn’t really have a sense of the scope and scale of these transitions to industry before now,” said Pham-Kanter, assistant professor at Drexel University and a senior fellow at Leonard Davis Institute of Health Economics at the University of Pennsylvania.“This study gives us a good start on knowing the current baseline in a medical specialty that has historically had a lot of industry ties,” she said.Pham-Kanter also cautioned against assuming that the pattern of FDA staffers leaving the agency to work for industry is troubling.“If individuals who work in industry are more informed about the regulatory process because of these employment transitions, that’s not a bad thing,” she said. “On the other hand, if former FDA staffers, in their current roles in industry, try to influence their former colleagues at the FDA, we should be concerned.”FDA spokesman Jason Young noted that the revolving door dynamic is not unique to the agency.“The FDA has a strong set of rules in place to ensure that our employees are working in the public interest, not to advantage any company, organization, or individual,” Young said.After they leave the agency, Young said, they are subject to additional rules that protect confidentiality of information they worked on while in federal service, a cooling-off period for senior employees, and other post-employment restrictions.Prasad is not convinced there’s no conflict of interest.“I’m not paranoid. These are good people,” he said. “But like all people, we’re swayed.” Related: Please enter a valid email address. BusinessFrom FDA expert to biotech insider: The drug industry thrives on the revolving door Prasad launched the study after asking colleagues who study medical ethics whether anyone knew how often reviewers went from the FDA to industry.“Those of us who follow this field of FDA regulation know anecdotal stories of people who work for FDA and then immediately went to the drug industry,” said Prasad, “but nobody knew how often.”Prasad enlisted medical resident Dr. Jeffrey Bien, who serves as lead author. Prasad and Bien identified all the reviewers in the FDA hematology-oncology section who worked on applications between 2001 and 2010.Nearly half were still working at the FDA. But of the 26 who left the agency, 15, or nearly 58 percent, had gone to work in some capacity for biopharmaceutical companies. (Thirty percent of the reviewers who left the FDA could not be identified.)Genevieve Pham-Kanter, a well-known health economist who studies conflicts of interest in the regulatory field, praised the report. “I think it’s astonishingly high,” said Dr. Vinay Prasad, senior author on the paper and assistant professor of medicine at Oregon Health and Science University. “When you are talking about cancer drugs, with high toxicity and sometimes small benefit, it’s a place where judgment really matters. “Prasad also wonders if reviewers might make more favorable calculations if they are looking ahead to more lucrative industry work in the future.advertisement By Sheila Kaplan Sept. 27, 2016 Reprints Privacy Policycenter_img Tags cancerconflicts of interestFDApolicy Newsletters Sign up for D.C. Diagnosis An insider’s guide to the politics and policies of health care. FDA issues new draft guidelines for ‘appearance’ of conflicts of interest Chip Somodevilla/Getty Images WASHINGTON — Critics of the revolving door between government and industry cite the hundreds of lawmakers-turned-lobbyists as case studies in the art of cashing in on one’s years of public service.But less is known about the revolving door between the Food and Drug Administration and the biopharmaceutical industry.In a study published Tuesday in the journal BMJ, researchers who studied the careers of FDA medical reviewers found that more than half of the hematology-oncology assessors who reviewed drugs between 2001 and 2010 went on to work for the biopharmaceutical industry.advertisement “If you know a major post-employment opportunity is on the other side of the table, you give them the benefit of the doubt,” Prasad said. “You, maybe, make things a little easier on the companies.”last_img read more

Little Molly Mai’s fight for a school place receives national attention

first_img Community Charlie Flanagan on Electric Picnic: ‘I’d ask organisers to consult with community leaders’ RELATED ARTICLESMORE FROM AUTHOR Previous articleLISTEN: Football quarter-finals, Brody for an All-Star and Ladies football review – it’s our bi-weekly GAA podcastNext articleLIVE BLOG: Follow all the action from the SFC quarter final and JFC semi finals Siun Lennonún Lennon joined LaoisToday in a full-time capacity after studying Journalism and New Media in the University of Limerick. She hails from Rosenallis and her interests vary from news, sports and politics. Pinterest Twitter Home News Community Little Molly Mai’s fight for a school place receives national attention NewsCommunity New Arles road opens but disquiet over who was invited to official opening The Dollards lived in Bray until seven years ago, where Sarah-Jane’s son Ross was treated for epilepsy and autism.“Ross got all the Applied Behaviour Analysis (ABA) in Bray. He got an ASD unit, he got occupational therapy, physio, everything. Now because he got that ABA at a young age, he has come on in leaps and bounds. We’ve never looked back.“At the same time, I don’t know how Molly Mai is going to turn out – because she never got that early intervention,” admitted Sarah-Jane.We’ll be sure to keep an eye out on how this story unfolds for the Dollard family and little Molly Mai.SEE ALSO – Two communities come together after recent vandalism on Laois village and GAA Club By Siun Lennon – 14th September 2018 Little Molly Mai’s fight for a school place receives national attention Community center_img TAGSMolly Mai WhatsApp Facebook Twitter WhatsApp Pinterest Five Laois monuments to receive almost €200,000 in government funding Facebook Council Earlier this week, LaoisToday wrote an article on a Portlaoise family’s plight to try get their daughter Molly Mai a place in primary school.Martin and Sarah-Jane Dollard’s daughter Molly Mai was recently diagnosed with Asperger’s syndrome and ADHD, and suffers from a number of sensory issues.Four year old Molly Mai is due to start school in September, but with no spaces in ASD units in local mainstream schools, Martin and Sarah-Jane tried everything – from applying to St Francis Special School in Portlaoise, to looking at home tutors, and even the possibility of keeping Molly Mai back in preschool for another year.“We are desperately pleading for a school place for our child. We feel that she is being neglected by the State – that is honestly how we feel. Education is a fundamental human right – and Molly Mai isn’t receiving it,” said Molly’s Mai father Martin.Molly Mai’s story pulled at the heartstrings – and yesterday Sarah-Jane and Martin Dollard were invited onto Midlands 103 to talk about trying to get a place in school for their daughter.National attentionNow, RTÉ have contacted the Dollard family to arrange to come down to Portlaoise on Monday, September 17, and do a feature on either the Six One or nine o’clock news.Molly Mai’s mother Sarah-Jane says that she is overwhelmed with the response their story has received.“They want to do a piece comparing the services we got for Ross and what it’s like down here for Molly. Only for you putting our story out there we would not be in this position,” said Sarah-Jane.last_img read more

Van Zyl leads strong home contingent at S. Africa Open

first_imgGAUTENG, South Africa – Jaco van Zyl shot a 7-under 65 Thursday to top a South African-dominated leaderboard in the first round of the South African Open, the European Tour’s first event of 2016. Van Zyl maintained the form that put him in ties for eighth and 13th at the season-opening Alfred Dunhill Championship and Nedbank Golf Challenge before Christmas, making six birdies and an eagle. Shaun Norris was alone in second place after a 66, and Jbe Kruger and Keith Horne were tied for third at 5 under at Glendower Golf Club as South Africans filled the top four places. Two more were in a six-way tie at 4 under – Justin Walters and 2006 winner Retief Goosen. Defending champion Andy Sullivan of England shot 3 over and was 10 strokes off the pace. Play was suspended for the day because of the threat of lightning, with 33 players still to finish their rounds. Nicolas Colsaerts (shoulder) and Richard Finch (Achilles) retired in the first round. Van Zyl has 13 victories on South Africa’s Sunshine Tour but is yet to win on the European Tour, with the most recent of his four runner-up finishes coming at the Turkish Airlines Open in November. ”I’ve had a couple of weeks off, spending time with the family,” Van Zyl said. ”I’ve had my fair share of whisky and Christmas pudding so it was really nice to get off to a good start.” Starting at No. 10, Van Zyl picked up four shots on his front nine, and moved to 7 under after an eagle 3 at the par-5 second hole. He made up for his only bogey of the round, on No. 7, by making a birdie from three feet on the next hole.last_img read more