Ex-Southern Health boss gets £190,000 payoff for quitting advisory role

The former chief executive of a troubled mental health trust has been given a £190,000 payoff after she left her latest role.

Katrina Percy faced repeated calls to resign over Southern Health NHS foundation trust’s failure to investigate more than 1,000 unexpected deaths of patients with mental health problems and learning disabilities.

In August Percy resigned as chief executive but was moved to a role created for her by the trust with the same £240,000 salary and benefits package. She has now left that role after criticism from the public, patients and the families of those who died. It was confirmed on Friday she will receive a £190,000 settlement, the equivalent of one year’s salary.

Percy was under pressure to resign as chief executive following a series of damning reports on the trust’s failure to investigate deaths because of shortcomings on the board and by senior executives. But she was moved to a new role specially created for her.

Dr Sara Ryan, mother of 18-year-old Connor Sparrowhawk, who drowned in a bath after an epileptic seizure at Slade House in Oxfordshire in July 2013, was one of those who criticised the creation of a role for Percy.

On Friday the trust said: “Following the recent announcement that Katrina Percy will take on a regional strategic advisory role, we have received correspondence from the public, patients and families expressing their concerns. We have listened to all of this feedback and reflected.

“Both the trust and NHS Improvement believe it is no longer possible for Katrina to continue in her new advisory role. Katrina shares this view and we have worked with NHS Improvement to come to a settlement where she will leave Southern Health with immediate effect, to pursue other opportunities.

“We thank Katrina for her significant contribution to the NHS and we wish her well for the future.”

Last month the interim chair of the trust, Tim Smart, quit the organisation. He had been criticised over how the trust had continued to employ Percy.

A spokesman for NHS Improvement said there had been no legal grounds on which to dismiss Percy as chief executive and defended the payout.

“Tim Smart, as the then interim chair of the trust, received advice that there were no legal grounds upon which to dismiss her, and that doing so would open the trust and the wider NHS up to potential litigation and the very real possibility of significant costs to the taxpayer,” the spokesman said.

“He worked with Ms Percy to explore a way of her leaving her role as chief executive, but continuing to contribute to the future of patient services in Hampshire and the Isle of Wight in a very meaningful, but non-patient facing, way.

“As an adviser, Ms Percy’s strategic skills would be put to good use for a period of 12 months… we supported this. It has been clear in the weeks following the announcement – that this agreement cannot now be delivered.

“We have, therefore, worked with the trust to renegotiate for her to leave its employment immediately. Her contract with Southern Health entitles her to six months’ pay in lieu of notice. She will also be entitled to a further six months’ pay as part of the settlement. She will need to repay both of these payments if she gets a role in the NHS within the next 12 months.”

The spokesman added: “We know that this won’t please some who think she ought to have received no payment at all, and in situations like this, a perfect deal is not possible.”

Deborah Coles, director of Inquest, which has supported Sparrowhawk’s family, said: “The resignation of Katrina Percy should mark the end of Southern Health’s denial of responsibility for systemic failings and the start of vital work to protect the lives of the people in its care.”

Ex-Southern Health boss gets £190,000 payoff for quitting advisory role

FDA Advisory Panel Supports Novel Drug Coated Balloon

The FDA’s Circulatory Technique Gadgets advisory panel voted unanimously on Thursday to assistance approval of CR Bard’s CR Bard’s Lutonix Drug Coated Balloon. It would be used to enlarge arteries in a subset of individuals who have peripheral arterial disease– such as obstructive de novo or non-stented restenotic lesions (≤ 15 cm in length) in native femoropopliteal arteries with reference vessel diameters of 4 mm to six mm.

The PreMarket Approval (PMA) application is based mostly on the pivotal Levant two trial in which individuals had been randomized to the DCB or standard percutaneous transluminal angioplasty. The trial was productive in demonstrating the two the security and efficacy of the DCB. At one 12 months the primary efficacy endpoint– freedom from target lesion restenosis and target lesion revascularization– was significantly higher with the DCB (65.two% versus 52.six%).

However, the advisory panel invested significantly of the day making an attempt to interpret the complexities of the trial. There were a huge quantity of protocol violations in the control arm, so that the final results have been no longer considerable in the per protocol analysis. In addition, the DCB did not benefit women in the trial and the DCB was a lot more efficient in websites outdoors the US than in the US web sites.

“We genuinely had a challenging time,” mentioned panel member Rick Lange.  ”It looked like in the non-US sites there was a clear advantage, but in the US sites it was marginal, even though in females it didn’t appear like it was great.” Panel members had to make a decision whether to lump the data or split it. “We determined to lump it together,” stated Lange.

The unanimous vote, explained Lange, was a reflection of the committee’s view that the gadget was each protected and at least as effective as PTA. “It’s a minor less complicated than a stent considering that you are not leaving something inside,” he stated.

The panel urged the FDA to require the sponsor to offer prolonged-term information for the DCB, like a publish-approval research and continued followup of present sufferers. They said the outcomes review must be large adequate to review guys versus females and US versus non-US.

If it is accepted Lutonix would turn into the very first drug-covered balloon (DCB) obtainable in the US. A second DCB from Medtronic Medtronic is imagined to be about six months behind Lutonix in the approval process.

FDA Advisory Panel Supports Novel Drug Coated Balloon

FDA Advisory Panel Suggests Towards Approval Of Novartis Heart Failure Drug

The FDA’s Cardiovascular and Renal Medicines Advisory Committee voted unanimously  (eleven-) towards approval of the biologics license application (BLA) for serelaxin (proposed trade name Reasanz). The novel drug from Novartis was meant to be employed in patients with acute heart failure. The when extremely-promising drug, which received a ”breakthrough therapy” designation from the FDA last year, was also turned down for approval in Europe earlier this 12 months.

FDA reviewers and committee members expressed no substantial worries over the security of the drug.But they have been troubled by the seemingly impenetrable benefits of the pivotal Unwind-AHF trial. Throughout the day the Novartis speakers, including heart failure experts Milton Packer and Loosen up-AHF investigator Barry Greenberg, attempted to make clear and justify the complex trial, which only met one of its two co-primary endpoints.

But panel members remained skeptical. They located that flaws in trial design and style created it extremely hard to accurately assess the effect of the drug. They did not completely reject the surprising obtaining of a mortality reduction at 180 days in Chill out-AHF, but simply because it was not a prespecified endpoint they mentioned it necessary to be tested in a followup research.

Right after the vote most of the panelists advised the business to continue development of the drug given that it may possibly in the end help handle an important unmet healthcare need to have.

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FDA Advisory Panel Suggests Towards Approval Of Novartis Heart Failure Drug

FDA Advisory Panel Recommends Towards Approval Of New Medicines Firm Heart Drug

The FDA’s Cardiovascular and Renal Medicines Advisory Committee these days advised against the approval of cangrelor, the investigational new antiplatelet drug from the Medicines Firm. In a 7-2 vote the panel 1st rejected an indication  for the reduction of thrombotic cardiovascular occasions such as stent thrombosis in patients undergoing PCI.

The panel also voted unanimously to reject a second indication, for the maintenance of antiplatelet therapy in patients with acute coronary syndromes or sufferers with stents who have discontinued antiplatelet therapy due to the fact they are awaiting surgical treatment and are at higher threat for thrombotic occasions. FDA reviewers, who had delivered mixed opinions for the first indication, had suggested a total response letter for the 2nd indication, because the company had failed to complete a trial showing clinical advantage for the indication.

During the day panel members wrestled with issues with the pivotal CHAMPION PHOENIX trial, which attempted to treatment the deficiencies of two earlier damaging trials. Even though most panel members agreed that PHOENIX showed a advantage compared to the clopidogrel handle group, the advantage appeared small and the committee was concerned that cangrelor may possibly have acquired an unfair advantage simply because in the handle group clopidogrel was not used ideally, given that several  did not receive preloaded large-dose clopidogrel. An additional concern was that most of the difference amongst the groups was due to a reduction in periprocedural MIs. Panelists after again raised the query of the clinical relevance of this obtaining. Finally, the higher threat of bleeding with clopidogrel appeared to largely offset the observed advantages.

Panel member Milton Packer, who voted against approval, explained that he needed to vote yes and that he considered an antiplatelet agent with fast on/off properties may properly demonstrate beneficial. But, he said, the sponsor had not demonstrated that cangrelor was superior to full dose clopidogrel.

FDA Advisory Panel Recommends Towards Approval Of New Medicines Firm Heart Drug

FDA Advisory Panel Votes In Favor Of Approval For Merck"s Vorapaxar

(Photograph credit: Wikipedia)

The FDA’s Cardiovascular and Renal Medicines Advisory Committee voted ten-1 in favor of approval for vorapaxar, Merck’s Merck’s novel thrombin receptor antagonist. The “roller coaster ride” cliché may have been invented for this drug, which was the topic of tremendous early hopes followed by main disappointments and, finally, a subsequent revival.

The committee voted in favor of the drug for use as an adjunctive therapy for the reduction of atherothrombotic events in individuals with a background of myocardial infarction (MI). Panel chairperson Philip Sager explained that “this drug addresses a true unmet medical require and can make a real variation for sufferers.”

The University of Colorado’s Mori Krantz provided the a single unfavorable vote, however in his comments he indicated that he was not completely opposed to approval. He characterized his vote as a “formal dissent” and explained that he desired to get on the record his concerns about the large amount of individuals who would need to be taken care of with vorapaxar to stop a single occasion and his dread that the bleeding problems observed in the study may be amplified in the real world.

Sanjay Kaul stated that Merck ”convincingly demonstrated that the advantage exceeded the risk in the chosen patient cohort. Like all advancement programs, it has it’s fair share of warts, but there is an unmet need in this population where we have no safe and effective therapies accessible. Hopefully, if accredited it will be utilized in situations that optimize its advantage-risk profile.”

The panel spent much of the day wrestling with the complicated questions raised by the drug’s troubled history, in which a single massive trial, TRACER, was stopped early due to large charges of significant bleeding and the other trial, the TRA2P trial, was redesigned in midstream. But eventually the panel believed that TRA2P had been able to show that vorapaxar was successful in a post-MI population in which sufferers with a historical past of stroke had been excluded.

FDA Advisory Panel Votes In Favor Of Approval For Merck"s Vorapaxar

Johnson & Johnson Faces Uphill Battle At FDA Advisory Panel

The third time could not be the charm. Twice before the FDA has turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson &amp Johnson’s Xarelto (rivaroxaban). On Thursday the Cardiovascular and Renal Medication Advisory Committee will get up the sNDA nevertheless yet again, but FDA assessment documents posted today suggest that the organization will once more face an uphill battle.

Originally, back in 2011, most observers considered the ACS indication would be a snap. The pivotal ATLAS ACS 2-TIMI 51 trial was extensively praised when it came out and the FDA promptly granted priority review for the indication. But  momentum, as I’ve reported before, ground to a halt when FDA reviewers raised queries about the ATLAS trial. The FDA advisory panel, highlighted by vocal criticisms from Steve Nissen and Sanjay Kaul, resulted in a vote against the ACS indication, foremost to the very first comprehensive response letter. The FDA issued a 2nd total response letter final March but J&ampJ restated its self confidence in the trial and its commitment to pursue the indication.

The earlier rejections were based mostly largely on the significant amounts of missing followup information from the trial. The FDA and J&ampJ thought that this difficulty might be circumvented by pursuing an indication for a shorter 90-day remedy duration, given that significantly of the missing information was for longer followup. But the brief phrase information do not seem very convincing and the FDA reviewers make clear in the new assessment paperwork that they now have grave considerations about this technique. (For readers interested in the particulars and minutiae of FDA-sponsor interactions and negotiations, the briefing paperwork include a series of letters from the FDA that supply a fascinating retrospective view of this complicated process.)

There was much more negative news for J&ampJ in the announcement of the panel participants. Former critics Steve Nissen and Sanjay Kaul are on the roster again and will be joined by mentioned pharma critic Sidney Wolfe. In addition, and maybe even more unsafe for J&ampJ, is one of the scheduled FDA presenters, clinical reviewer Thomas Marciniak. He has turn into well recognized for his scathing critiques of rosiglitazone and the angiotensin receptor blockers in addition to rivaroxaban.

Johnson & Johnson Faces Uphill Battle At FDA Advisory Panel