martes, 22 de agosto de 2017

CDRH New Update

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CDRHNew

Date: August 22, 2017

The following new items were added to the CDRH web pages on August 21, 2017. Previous CDRHNew items can be found on the CDRHNew Page.

Career & Training Opportunities | NIH: National Institute of Allergy and Infectious Diseases

Career & Training Opportunities | NIH: National Institute of Allergy and Infectious Diseases

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"Flag with Flasks; Credit: NIAID"

Medical Officer (Clinical)

NIAID seeks exceptional and motivated clinicians for medical officer positions within the Division of AIDS. Responsibilities will relate to the development and medical oversight of clinic trials sponsored by the division for the prevention and/or treatment of HIV/AIDS and/or related co-infections such as tuberculosis and hepatitis B. Candidates must be U.S. citizens, have an M.D. or D.O., and have an active medical license. 
The position is now open on www.USAJobs.gov until August 25, 2017. Search vacancy announcement NIH-NIAID-DH-17-1974690 to apply!
Visit NIAID Careers now for additional information.

HHS, NIH, and NIAID are equal opportunity employers.

FDARA: Making a Difference for Industry and Patients | FDA Voice

FDARA: Making a Difference for Industry and Patients | FDA Voice

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FDARA: Making a Difference for Industry and Patients

By: Peter Marks, M.D., Ph.D., Jeffrey Shuren, M.D., J.D., and Janet Woodcock, M.D.
Peter Marks
Peter Marks, M.D., Ph.D., Director of FDA’s Center for Biologics Evaluation and Research
For decades, user fees paid by the medical products industry have provided critical resources needed to conduct product reviews in a timely fashion and to help ensure the safety and effectiveness of medical products that American patients depend upon.
Since passage of the first medical product user fee act in 1992, the user fee laws and corresponding performance goals and program enhancements have helped evolve the drug and device review process in the United States allowing patients access to new and innovative treatments as quickly as possible without compromising the Agency’s high standards.
As directors of FDA’s three medical product centers, we want to applaud the U.S. Congress for passing the FDA Reauthorization Act of 2017 (FDARA), which President Trump signed into law on Friday.
Jeff Shuren
Jeffrey Shuren, M.D., J.D., is Director of FDA’s Center for Devices and Radiological Health
FDARA reauthorizes the Prescription Drug User Fee Act (PDUFA) for the fifth time, the Medical Device User Fee Amendments (MDUFA) for the third time, and both the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA) for the first time – allowing FDA to continue to collect medical product user fees through fiscal year 2022. The new law marks the culmination of two years of negotiations with industry and discussions with stakeholders. This is a compelling example of what can be achieved when FDA, industry, patients, Congress, and other stakeholders work together towards the same goal.
FDARA builds upon the goals outlined in previous user fee agreements and in the 21st Century Cures Act and will help us continue the essential work we are doing in many of our priority areas. The new law provides critical support for important FDA activities related to medical product regulation, including:
  • Enhancing our ability to capture the patient voice in drug development.
  • Allowing FDA flexibility to inspect medical device facilities based on risk, enabling the Agency to focus its resources where they are most needed, while providing greater predictability and transparency to the inspection process.
  • Advancing and facilitating the development and timely approval of drugs and biologics for rare diseases, including diseases of children. In particular, FDARA provides the FDA with new authority to require a pediatric investigation into an adult cancer drug if that drug is directed at a molecular target that is relevant to a pediatric cancer.
  • Providing resources for the popular, highly successful, and resource intensive breakthrough therapies program for drugs.
  • Continuing to leverage the use of “real-world” health data to inform regulatory decision making, including enhancing the capabilities of FDA’s Sentinel System for drugs.
  • Strengthening our partnership with patients, by providing funding for the development of  the National Evaluation System for health Technology (NEST) to help pay for a NEST Coordinating Center and pilot projects. NEST is intended to facilitate the use of real world evidence to support premarket activities.
  • Establishing a flexible and more efficient path to market for certain new medical device accessories, to enable new and innovative accessories to come to market more rapidly and enable accessories to be used with a wide range of devices – creating important options for patients.
  • Creating a category of over-the-counter hearing aids which will help lower costs and enable access for patients who greatly need these devices.
  • Providing new opportunities for early consultation on the use of new surrogate endpoints.
  • Streamlining combination product review to enhance coordination and transparency between FDA and industry.
  • Improving FDA hiring and retention efforts including a dedicated unit for scientific staff and continuous independent assessment of the Agency’s hiring and retention operations.
Janet Woodcock
Janet Woodcock, M.D., Director of FDA’s Center for Drug Evaluation and Research
FDARA will help FDA continue to fulfill its important public health mission.
As a whole, the reauthorization of PDUFA, MDUFA, GDUFA, and BsUFA will allow FDA to improve upon the demonstrated successes of these programs, and in so doing, further benefit patients and affirm our nation’s standing as a global leader in biomedical innovation.
Peter Marks, M.D., Ph.D., is Director of FDA’s Center for Biologics Evaluation and Research
Jeffrey Shuren, M.D., J.D., is Director of FDA’s Center for Devices and Radiological Health
Janet Woodcock, M.D., is Director of FDA’s Center for Drug Evaluation and Research
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Talco: Johnson & Johnson deberá pagar 353 millones por un cáncer debido a su polvo de talco | Internacional | EL PAÍS

Talco: Johnson & Johnson deberá pagar 353 millones por un cáncer debido a su polvo de talco | Internacional | EL PAÍS

Johnson & Johnson deberá pagar 353 millones por un cáncer debido a su polvo de talco

Una mujer contrajo cáncer de ovarios tras usar el producto durante años. Hay casi 5.000 demandas pendientes

Johnson's Baby Powder



Bote de polvos de talco de Johnson's.  AP



Un tribunal de Los Ángeles (California) ha condenado a Johnson & Johnson (J&J), el gigante de los productos de higiene y de farmacia, a pagar 417 millones de dólares (unos 353 millones de euros) a una mujer que desarrolló un cáncer de ovarios después de usar durante años el polvo de talco de la empresa. La condena se basa en que J&J no advirtió adecuadamente del riesgo de cáncer asociado al uso de productos con talco, especialmente el llamado Johnson's Baby Powder .
El caso ahora resuelto es uno de los miles presentados en todo Estados Unidos contra la compañía por la omisión de avisos de los riesgos del producto. De hecho, todavía hay más de 300 demandas pendientes en California y más de 4.500 denuncias en todo el país. Este caso es especial, ya que la empresa ha sido condenada a indemnizar a la víctima con 70 millones de dólares y a abonar otros 347 millones de multa por "daños punitivos".
Eva Echevarria. La foto ha sido facilitada por Robinson Calcagnie.
Eva Echevarria. La foto ha sido facilitada por Robinson Calcagnie.
El caso ahora sentenciado fue presentado por Eva Echeverria, de 63 años, a la que se le diagnosticó un cáncer de ovarios en 2007, tras utilizar talco de la compañía en su zona genital durante años. A Echeverria se le extirpó el tumor, pero no pudo asistir al juicio por su delicado estado de salud, según uno de sus abogados.
"Estamos agradecidos por el veredicto del jurado en esta materia", ha señalado su abogado Mark Robinson, quien también ha asegurado que Johnson & Johnson trató de "ocultar la verdad durante muchos años".


Mientras tanto, la compañía ha anunciado que apelará el veredicto. "Apelaremos porque, basándonos en la ciencia, estamos convencidos de la seguridad de los polvos de talco Johnson's Baby Powder", ha declarado la portavoz de la empresa Carol Goodrich. Esta citó un reciente informe del Instituto Nacional del Cáncer (National Cancer Institute's Physician Data Query), según el cual nada apoya el que exista una relación entre el cáncer de ovarios y la exposición de la región genital al polvo de talco.

Gardasil: Fast-Tracked and Flawed |August 22, 2017| MercatorNet |

Gardasil: Fast-Tracked and Flawed

|August 22, 2017MercatorNet |







Gardasil: Fast-Tracked and Flawed

A decade since the launch of the vaccine a book questions the claim it prevents cancer.
Carolyn Moynihan | Aug 22 2017 | comment 


HPV Vaccination in Sao Paulo 2014. Pan American Health Organisation/Flickr
The Australian government is likely to provide a new version of the vaccine that is said to prevent cancer soon. Gardasil 9 would replace the original Gardasil -- administered to young high school students in three doses – with a two-dose regime involving a stronger formula that is already used in New Zealand and the United States. The vaccine promises protection against the human papillomavirus (HPV), certain strains of which, it is generally accepted, can cause cervical cancer.
Like the original roll-out of the drug 10 years ago and promotions since, this one is being heralded by very optimistic messages: “New cervical cancer vaccine may almost eliminate disease, research shows,” ran a recent headline. "It's truly ground-breaking," the scientist who led the new research, Professor Julia Brotherton, told the ABC. “The possibility that we can now prevent our children being infected with this cancer-causing virus, I just think that's amazing."
But not everybody is so happy about Gardasil. In addition to the anti-vaccine camp, there are parents, women’s health activists and some doctors who question the way it was hustled into national health systems, its safety, and its claims.
One dissenter is Helen Lobato, author of an expose published recently by Australian feminist publisher Spinifex. In her introduction to Gardasil: Fast-Tracked and Flawed she says:
“Fast-tracked and poorly tested vaccines are now given to young girls and boys because of a link between the human papilloma virus and cervical cancer. … [T]hese vaccines are not only unproven but the vaccinated girls and boys can suffer devastating adverse effects that result in permanent ill-health and even death for some of them.”
Lobato, a former nurse, had her own brush with cervical cancer in 1985. This gives her a personal stake in the representation of the disease today. Like many other women, she may have been saved from full-blown cervical cancer by having a Pap smear (a test that dates back to the 1940s and has been offered through national screening programmes in more recent decades) that allowed timely (if somewhat brutal, in her experience) treatment for a pre-cancerous condition.
In fact, the effectiveness of cervical screening is a key argument in her case against the HPV vaccine. Others are: it was rushed onto the market after inadequate trials; it is associated with thousands of adverse reactions and some deaths; it is administered without adequate informed consent; there is no proof that it can prevent cervical cancer.
Is this vaccine really necessary?
When a lay person considers a vaccine they think in terms of being protected against a widespread contagious disease. HPV is, apparently, such a disease. It is said that around 80 percent of people who have sex at all will get this infection at some stage. But we are also told that 90 percent of the infections will clear within a year. So why vaccinate as many girls and boys as possible against it? Because 10 percent may be at risk of cancer?
But the incidence of cervical cancer in countries like Australia is nothing like 10 percent. It is less than 1 percent, Lobato reports. (P 81) There is no epidemic of cervical cancer in any developed country (it is a different story in developing countries).
Moreover deaths from this cancer in Western countries is even rarer – at the rate of 1.7 per 100,000 women in Australia, which in 2014 amounted to 223 deaths from the disease -- compared with 2,844 deaths from breast cancer (a figure which is expected to rise). Cervical screening is said to have halved the number of deaths since 1991, though Lobato believes that improvements in living standards played a part.
Her reading of the history of the disease suggests that poverty (including poor nutrition and hygiene) played a large part in earlier times, and more recently the contraceptive pill (its effect on immunity), smoking and other lifestyle factors. She discounts early theories that linked cervical cancer to “sexual excesses and immorality” and regrets that the current focus on HPV has swung the pendulum back in this direction.
The race to provide a vaccine
The hypothesis that HPV and cervical cancer are linked goes back several decades, and the idea of a vaccine against the STD was first mooted in the 1970s. Research began in several centres but in the end it was an Australian team – Scottish-born Professor Ian Frazer, and Dr Jian Zhou, at the University of Queensland – that made the breakthrough by producing a synthetic version of the HPV virus in 1991.
From the late 1990s in Australia and internationally, Lobato says, “a relentless propaganda campaign” for the vaccine began to build. This reached its peak in 2006, when Frazer was hailed as a national hero (Zhou died in 1999) and he personally vaccinated the first woman at the Sydney launch. There were 947 pieces of media devoted to the Australian campaign, driven by PR giant Edelman.
US television hosts hailed the vaccine as “a triumph in science and medicine” and something that “could save your teenager’s life someday”. Based on a US television advertisement featuring health young girls, “One less” (victim of cervical cancer) became an international slogan – as though victims were dropping like flies.
“Gardasil was fast-tracked through the FDA [the US Food and Drug Administration], a process usually reserved for life threatening diseases to fill an unmet and urgent medical need,” says Lobato. For her, this was a coup for Big Pharma rather than women or even public health. The drug companies, which funded the trials, stood to gain huge revenues.
In November 2006 the vaccine was listed on Australia’s national immunisation register and on International Women’s Day 2007 the program was launched.
The vaccine is provided free through schools to girls aged 12 and 13, and to boys on the same basis since 2013. Up till now, three injections are given over six months. And yet Gardasil had been tested on fewer than 1200 girls under the age of 16 when the national program began. Cervarix, the other brand used in Australia and Europe, was also studied in a small number of young girls.
Lobato quotes Diane Harper, one of Merck’s HPV vaccine researchers “and now a whistleblower,” saying that the roll-out “went too fast, without any breaks.”
Adverse reactions, deaths: what’s in Gardasil?
That was in 2008 and Harper was commenting on the mounting toll of side effects being reported – the dominant concern of Lobato’s book. It begins with the case of Australian woman Krisitn Clulow, who received her first two shots of Gardasil in May and August 2008 and whose health thereafter collapsed owing to an inflammatory disease of the brain. With treatment she recovered by 2010. A homeopath who helped her recovery informed her that her body was high in aluminium.
“Aluminium is a neurotoxin,” says Lobato, and each dose of Gardasil contains 225 micrograms of it as an adjuvant – a booster of the essential ingredient. Gardasil 9, approved by the FDA in 2014 for the prevention of cervical, vulvar, vaginal and anal cancers will contain 500mcg of aluminium and a larger dose of antigens (the HPV LI proteins). Cervarix also contains the chemical in the form of aluminium hydroxide.
Lobato regards this as a major reason that “HPV vaccines are associated with more deaths, and serious adverse effects than other vaccines.” According to the World Health Organisation’s Vigibase, there are now over 73,000 recorded adverse events after HPV vaccination. Lobato says there have also been at least 324 deaths.
All vaccines have side effects, but the fact that an illness or death occurred after vaccination is not proof that it was caused by the vaccine. Also, the plausibility of the case against the HPV vaccine is influenced by one’s attitude to vaccines in general, and Lobato seems to lean to the anti-vaccination camp.
Nevertheless, the National Vaccine Information Center in the US published a Gardasil risk report in 2009 which found that death and serious adverse events are reported three to 30 times more often after Gardasil than after the meningococcal vaccination Menactra.
This data needs scientific study, but it will be difficult for interested scientists to get funding for such research in the current climate. Australian GP Deirdre Little has documented in medical journals three cases of premature ovarian failure (early menopause) in adolescent girls who had been vaccinated with Gardasil, and she has questions about the vaccine’s safety – and the manufacturer’s research -- from that point of view.
No proof that HPV vaccination prevents cancer
“We can now prevent cancer.” Lobato says there is no proof that this is the case. This is because HPV vaccines have never been tested against cervical cancer outcomes only against surrogate endpoints: cervical intra-epithelial neoplasia (CIN) garde 2/3 lesions, and carcinoma in situ. These precursor lesions are common in women under 25 but rarely progress to cancer, according to Lobato.
To have allowed human test subjects to progress towards cancer in order to prove its efficacy at that point would be unethical, so there is nothing wrong with using surrogate endpoints, but the claims should be correspondingly modest. Instead, public messaging has harped on the cancer prevention potential of the vaccine – really, to maximise the number of young people receiving it. Basically, those young people are part of an experiment. A good experiment, perhaps, but shouldn’t parents and the wider public be informed that it has a downside?
Lobato concludes her book with an appeal to the media to do their job and give the public the fuller story about the HPV vaccine. You may not agree with her version of the story at all points, but she has shown Big Media some of the things they could be airing in the interests of informed debate.
Carolyn Moynihan is deputy editor of MercatorNet.


MercatorNet

August 22, 2017

You may have noticed more and more news about same-sex marriage in MercatorNet. Yes, there are more important issues than the upcoming plebiscite in Australia. But that’s where the editor lives and he cares about the future of marriage. So please pardon another brief message.
A loyal subscriber recently wrote to us and posed a very sensible question:  
I notice that you are using the expression “legalisation of same-sex marriage”. This, along with “allowing same-sex marriage” seems to me to be a mistake. There is nothing illegal about same-sex marriage. People are allowed to marry others of the same sex, to have wedding ceremonies, and live together legally as married couples. It’s just that the state does not call such relationships marriage.
If the question in the plebiscite is “Should same-sex marriage be legalised?” or “Should same-sex couples be allowed to marry?” it will probably be approved overwhelmingly, because voters will be led to feel that something is currently unfairly prohibited and in fact it is not.
As far as I have seen, no one has suggested a wording for the question, yet I believe it is crucial to the outcome. Maybe you could ask your readers to suggest their ideas for the wording for the question that is most likely to elicit the true feelings of the voters?
Any ideas? 



Michael Cook
Editor
MERCATORNET














About that poster
By Michael Cook
A poster in Melbourne against same-sex marriage may be offensive and provocative, but its statistics are correct
Read the full article
 
Gardasil: Fast-Tracked and Flawed
By Carolyn Moynihan
A decade since the launch of the vaccine a book questions the claim it prevents cancer.
Read the full article
 
My lunch with a Nazi
By Jeffrey A. Tucker
They still exist. And some of them are cultured and rich.
Read the full article
 
News flash! New sin discovered!
By James Schall SJ
The sins of our time are sins against God the Creator
Read the full article
 
What happened when we introduced 4-year-olds to an old people’s home
By Melrose Stewartand Malcolm Johnson
It does wonders for the health and mood of the elderly
Read the full article
 
The ethical spin on spinners
By Karl D. Stephan
Yet another example of the power of marketing to get people to buy something they never knew they wanted
Read the full article
 
If you don’t like plural marriage, don’t get plural married
By Michael Cook
Will LGBT bigotry be the biggest obstacle to legalising polygamy?
Read the full article
 
The sweatshirt that lasts 30 years
By Shannon Roberts
Choosing quality over quantity.
Read the full article


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Gardasil: Fast-Tracked and Flawed