Autores de articulos legalmente responsables en caso de lesiones del paciente


Proponen que los autores firmantes de un artículo sean legalmente responsables en caso de que el paciente sufra lesiones

JANO.es · 30 Enero 2012 1
Un triunvirato de expertos plantea que los médicos que avalen trabajos realizados según las directrices de laboratorios farmacéuticos sean legalmente responsables ante la posibilidad de que un paciente sufra lesiones.

Proponen que los firmantes sean legalmente responsables ante la posibilidad de que los pacientes sufran lesiones.
El investigador español Xavier Bosch, del Hospital Clínic, ha planteado en un artículo publicado en PLoS Medicineque se adopten medidas legales para luchar contra el llamado ‘medical ghostwriting’, práctica consistente en conferir autoridad a un texto pseudopublicitario por el procedimiento de contratar la firma de un ‘autor invitado’.
Bosch y los coautores del artículo, Bijan Esfandiari, abogado en un bufete de Los Ángeles especializado en malas prácticas médicas, y Leemon McHenry, investigador del Departamento de Filosofía de la Universidad Estatal de California, recogen tres modelos teóricos de responsabilidad penal que afectarían principalmente a estos ‘guest authors’.
Así, los expertos proponen que los firmantes sean legalmente responsables ante la posibilidad de que los pacientes sufran lesiones por causa de una práctica que aquéllos han avalado, y plantean que esas mismas responsabilidades se extiendan a las empresas patrocinadoras. Ambos planteamientos se basan en que los artículos pueden influir en el juicio clínico, aumentar las ventas de productos y los costes de atención sanitaria del gobierno, y poner a los pacientes en riesgo.
Los autores también consideran una forma de ghostwriting “las conferencias y los congresos médicos sobre enfermedades en los que se habla de los beneficios de un producto, si el discurso ha sido preparado a partir de las directrices de una compañía”.

Ver artículo en PLoS MEDICINE

  • Despite growing concern about medical ghostwriting, pharmaceutical companies, universities, medical journals, and communication companies employing ghostwriters have thus far failed to adequately stem the problem. As a result, some commentators have proposed that legal remedies could be sought by patients harmed by drugs publicized in ghostwritten papers.
  • In this Essay, we build on a recent analysis by Stern and Lemmens in PLoS Medicine to outline specific areas of legal liability.
  • For example, when an injured patient’s physician directly or indirectly relies upon a journal article containing false or manipulated safety and efficacy data, the authors, including guest authors, can be held legally liable for patient injuries.
  • In addition, guest authors of ghostwritten articles published by Medicare- and Medicaid-recognized peer-reviewed medical journals used as clinical evidence for indications for off-label uses may be liable under the federal False Claims Act for inducing the United States government to reimburse prescriptions under false pretenses.
  • Paying guest authors of ghostwritten papers may influence clinical judgment, increase product sales and government health care costs, and put patients at risk by misrepresenting risk-benefit. Therefore, both physicians and sponsor companies may be liable under the federal Anti-Kickback Statute.
  • Although guest authors and pharmaceutical defendants may argue a First Amendment right to participate in ghostwriting, the US Supreme Court has firmly held that the First Amendment does not shield fraud.

California Gov Signs Controversial Vaccine Law


California Gov Signs Controversial Vaccine Law

vaccine-flickr1Following months of controversy, California Governor Jerry Brown late last week signed into law a bill that removes parental consent for vaccinating children 12 and older against sexually transmitted diseases. Although state law already allows children 12 and older to consent to treatment for sexually transmitted diseases without parental involvement, the new law expands that right to immunizations.
The bill (read here) had been strongly opposed by several organizations that argued minors do not have adequate judgment to make a decision about vaccination (back story). The legislation also figured into the wider national debate in recent weeks over HPV vaccines, concern among social conservatives about teenage sex and the extent to which drugmakers have worked to influence introduction and passage of such bills (see here andhere).
At issue is a furor that has plagued Merck and its Gardasil vaccine. The FDA approved the shot five years ago to protect girls and women ages 9 to 26 against four strains of the human papillomavirus, or HPV, which can lead to cervical cancer. Social conservatives and some parents, however, are concerned that teenagers may interpret vaccination as a green light to engage in premarital sex. Brown did not issue a statement upon signing the bill (look here), but one group is spitting mad.
“By signing AB 499 to coerce minors into risky Gardasil shots, Jerry Brown is deceptively telling preteen girls it will protect them from HPV, giving them a false sense of security that they can have all the sexual activity they want without risking developing cervical cancer or a raft of other negative consequences,” says Randy Thomasson, president of SaveCalifornia.com, in a statement.
In contrast to such sentiments, public health officials have recommended HPV vaccination – including the Cervarix vaccine sold by GlaxoSmithKline – as a useful tool to thwart the advent of cervical cancer. Nonetheless, Gardasil has been dogged by questions over side effects, cost and long-term effectiveness. Meanwhile, teenage vaccination rates for the HPV vaccine are trailing the other two vaccines recommended for teens and pre-teens, according to the Centers for Disease Control and Prevention (read here). To some extent, the concerns over Gardasil reflect the wider controversy over vaccine safety, in general.
Merck, however, fueled the debate over HPV vaccination by employing a surreptitious marketing campaign several years ago in which the drugmaker backed Women In Government, a non-profit group of state legislators, in hopes that mandatory vaccination bills for school-age children would be introduced nationwide. The effort backfired, though, and Merck ended its lobbying (back story).
But the issue re-emerged last month, when Texas Governor and Republican presidential candidate Rick Perry said his decision to sign an executive order to create a mandate. The state legislature later overturned the order, but Perry’s ties to Merck at the time became campaign fodder. These included Merck donations in the years prior to his order (read here).
The unexpected attention cast a bigger spotlight on the bill in California, where many members of the state senate and assembly who voted to approve the legislation also received money last year from Merck. This group included representative Toni Adkins, who introduced the bill and earlier this summer denied that she ever received money from the drugmaker (see here).
vaccine pic thx to lulu on flickr