ZGNX http://www.conferencecalltranscripts.org/summary/?id=1187821
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El reporte de ventas a fecha 26/09/2014 -- 1,375 scripts por semana un salto en relación con reporte anterior,total 14,752 para el trimestre. pero los gastos en demanda y abogados los espero altos en Q3
Primer caso de ebola en Europa. Una técnico sanitario en contacto con los dos españoles repatriados en España.
Lo peor de todo es ver a la ministra gestionando la crisis, si dice que está todo controlado, correr y no parar, no tienen bastante con arruinarnos y robarnos que quieren exterminarnos.
After months of intensifying criticism over its decision to approve the Zohydro ER prescription painkiller, the FDA is trying to push back.
In a piece in the Journal of the American Medical Association last week, three FDA officials write that not only was the approval warranted, but that scolding the agency is misguided. Why? Targeting the shortcomings of one drug and advocating for restrictions on its use during an “epidemic” of opioid usage is not going to address the underlying problem of widespread abuse and inappropriate prescribing, they argued.
“The problem of opioid overdose demands well-informed policies. The actions taken by FDA may help to reverse the epidemic,” they write in JAMA. “…Policies that focus on a single drug can divert focus from broader, further-reaching interventions… The concerns over Zohydro ER should be seen in the greater context of the opioid epidemic. Singling out one drug for restrictions is not likely to be successful.”
The opinion piece, which was co-authored by Janet Woodcock, who heads the FDA Center for Drug Evaluation and Review, was published online one week after more than a dozen patient advocacy groups called for FDA commissioner Margaret Hamburg to resign. In their view, the agency has been “putting the interests of analgesic makers ahead of the public’s health.”
Criticism over the Zohydro ER approval has come from several quarters, in fact. Members of Congress, governors from five New England states and attorneys general from 28 states, have asked the FDA to reconsider its decision. The approval, which was made a year ago, was issued despite a recommendation by an agency advisory panel that the drug should not be made available.
Zohydro ER is the only opioid painkiller to contain nothing but hydrocodone; unlike other opiates, the drug does not contain acetaminophen, which can cause liver damage. That feature was seen as a plus. But while the pill is designed to be released slowly over a 12-hour period, it lacks crucial abuse-deterrent features, because the pill can be crushed, chewed or mixed with alcohol to provide a kick.
For its part, the agency continues to maintain that Zohydro ER, which is sold by Zogenix, represents a safe and effective alternative for physicians seeking to treat patient pain, and has denied overstating the number of pain patients. “We really have to change the inappropriate prescribing, which is the underlying driver of the problem,” Chris Jones, a senior advisor in the FDA Office of Policy and Planning, tells us.
In their essay, he and the other FDA officials maintain the agency has taken steps to address the need for abuse-deterrent painkillers. They point to guidelines issued for drug makers and a recommendation that hydrocodone combination products should be harder to obtain under the Controlled Substances Act. But they argue the issue is more complicated than critics may either acknowledge or understand.
In referring to recommendations from its own advisory panel for abuse-deterrent features, the agency officials wrote that “although this is an appealing policy solution, the science of abuse deterrence is uncertain and evolving… No marketed opioid with purported abuse-deterrence technologies has been shown to deter oral abuse – the most common route – or to reduce addiction or death.”
They also chastised emergency rules issued by some states to restrict Zohydro ER prescribing and argue these “do not target the prescribing of the more than 100 other opioid products on the market – the known drugs that have caused serious public health consequences for more than a decade. A preferable approach would be to revise these rules to make them applicable to all opioids as a new standard of care.”
The FDA also suggests studying a program in Florida, where opioid overdose deaths declined after the state required tougher enforcement actions against inappropriate prescribing; required clinics owned by physicians to register with the states, and also prohibited physician offices from dispensing drugs on the Schedule II and III lists of the Controlled Substances Act, which restricts distribution.
Nonetheless, one FDA critic called the JAMA piece a “public relations” exercise. “Zohydro was not brought to market because we needed more options. It was brought to market because profits could be made,” wrote writes Andrew Kolodny, chief medical officer at Phoenix House, a non-profit that runs alcohol and drug abuse treatment and prevention programs. He also heads Physicians for Responsible Opioid Prescribing, which was one of the groups that called for Hamburg to resign.
“We’ve got methadone, morphine, oxycodone, hydromorphone, oxymorphone, fentanyl and other opioid molecules. The rest of the world gets by just fine without any hydrocodone-containing analgesics, yet we had to have an extended-release version of the drug?”
THE WALL STREET JOURNAL
What a Pain! FDA Fires Back At Critics of its Zohydro Policy
Zogenix officials, meanwhile, have argued they have not noticed an uptick in abuse attributed to their drug. More recently, the drug maker applied to the FDA for permission to market an abuse-deterrent version of the pill. We asked Zogenix if there was any comment and will update you accordingly.
[UPDATE: The drug maker sent us a note to say it "strongly believes that the first line of defense is educating prescribers, pharmacists and patients about the risks, benefits and appropriate use of opioids. Zogenix has implemented the FDA’s Risk Evaluation and Mitigation Strategy program for extended-release/long-acting opioids... and is pleased that the available surveillance data demonstrate that these efforts are working."]
zgnx
rebota o pinta mal stop colocado.
Lo peor es que voy a morir ppr ebola antes de que Amrn termine el reduce-it....
Cago en todo!
menuda cagada, MENUDA CAGADA!
la enfermera con fiebre tras tratar a un paciente con Ebola y se va de vacacioneeeeesssssss!!
Pero que es estoooo!
No han dicho en la tele que las farmas con una posible vacuna es una alemana y otra americana?
y no te resulta aun más preocupante el hecho de que una ENFERMERA se haya contagiado tratando a un enfermo con ebola diagnosticado?
Me parece surrealista, dudo que haya sido por un descuido de ella, a saber el "protocolo" que realmente pueden seguir, porque no dudo que papel en mano todo está perfecto pero y los medios reales?
En fin, un desastre.
