MERCK: Gardasil will become the "Greatest Medical Scandal of All Time" / Dr. Bernard Dalbergue pero...

Dr. Bernard Dalbergue, a former pharmaceutical industry physician with Gardasil manufacturer Merck, was interviewed in the April 2014 issue of the French magazine Principes de Santé (Health Principles).

Excerpts: 

• The full extent of the Gardasil scandal needs to be assessed: everyone knew when this vaccine was released on the American market that it would prove to be worthless! Diane Harper, a major opinion leader in the United States, was one of the first to blow the whistle, pointing out the fraud and scam of it all. 
• Gardasil is useless and costs a fortune! In addition, decision-makers at all levels are aware of it! 
• Cases of Guillain-Barré syndrome, paralysis of the lower limbs, vaccine-induced MS and vaccine-induced encephalitis can be found, whatever the vaccine. 
• I predict that Gardasil will become the greatest medical scandal of all times because at some point in time, the evidence will add up to prove that this vaccine, technical and scientific feat that it may be, has absolutely no effect on cervical cancer and that all the very many adverse effects which destroy lives and even kill, serve no other purpose than to generate profit for the manufacturers. 
• There is far too much financial interest for these medicines to be withdrawn.

Sin embargo no todos están de acuerdo...:

Yes, out of the blue, the vaccine denialist cult is going to foist another individual who will trumpet the evils of vaccination. No, it’s not another Jenny McCarthy. Or Alicia Silverstone. Or Mayim Bialik. 

Bernard Dalbergue / Liberation

No, this is big time. Wait for it. This is really big. 

It’s Bernard Dalbergue. 

I think I hear chirping crickets out there. No, I had no idea who this dude was, so as a public service, I decided to find out what I could find out. 

So who is this Bernard Dalbergue and why is he important to the antivaccinationists? Well, it’s because, as the antivaccination fringe proclaim loudly, Dr. Dalbergue is a “former pharmaceutical industry physician with Gardasil manufacturer Merck.” And he apparently made some nasty comments about Gardasil in the April 2014 issue (pdf, French) in the French anti-science magazine Principes de Santé (Health Principles).(...)

Dr. Dalbergue’s story seems awfully like Dr. Harper’s. Except for the small fact that I can find no evidence that he ever worked for Merck (as opposed to Dr. Harper, who actually did, though not quite in the role she and the antivaccine world claimed). As far as I was able to uncover through sources and background checks, Dr. Dalbergue was the Directeur Medicale (Medical Director) of a drug distributor, Martin & Harris Pvt. Ltd. Let’s look at this step by step. Every medical products distributor in the world has a Medical Director, someone who signs off on documentation, occasionally holds pharmacy licenses, and provides advice on medical issues to the partners, principles and executives of the company. 

A Medical Director is almost always a critical role in pharmaceutical companies undergoing research and development. Almost every medical or pharmaceutical company must have an MD approve regulatory documents. However, being a Medical Director for a minor pharmaceutical distributor, by itself, lends no credence to a statement that he was deeply involved with Merck. 
He was not employed by Merck.(Más)

Ver también:

Ratón de biblioteca: Omerta Dans Les Labos Pharmaceutiques / Dr. Bernard Dalbergue & Anne-Laure Barret

Gardasil vs Cervarix: Se conocen ya resultados...Cervarix "gana."

Alertamos...ahora se conocen ya resultados y, de momento, dan "ganador" a Glaxo.

LONDON -- Drugmaker GlaxoSmithKline said Friday that results from the first, large-scale comparative trial between licensed human papillomavirus vaccines show that GSK's Cervarix generated a significantly higher immune response compared to Merck & Co's Gardasil. The trial showed neutralising antibody levels for Cervarix vaccine were more than two times higher than those for Gardasil vaccine for HPV type 16, and more than six times higher for HPV type 18, GSK said. These results were highly statistically significant, it added.

Ver...

Nevertheless, U.K.-based Glaxo hopes the results, to be presented at a Swedish medical conference that begins Friday, will help give Cervarix a competitive edge if it reaches the U.S. market, which Merck has had to itself since Gardasil's launch in 2006. The U.S. Food and Drug Administration is reviewing Cervarix and could decide whether to allow it to go on sale by autumn. Cervarix is already on the market in other countries including the U.K.

"The study clearly shows a higher level of immune response in women receiving Cervarix than Gardasil," Gary Dubin, vice president of global clinical development in Glaxo's vaccine unit, told Dow Jones Newswires in an interview.

Mas...

GARDASIL: Se recorta más el mercado para Merck...

Quisieron extenderlo por encima de los 26 y la FDA lo rechazó...

Nuevos estudios consideran que GARDASIL no sería "cost-effective" sino en adolescentes. Que su administración por encima de 18 años no justifica el gasto.


"The findings may raise qualms for Merck, which recently stepped up marketing to women ages 19 to 26 after Gardasil sales declined 9 percent to $326 million last quarter."

.../...

"Gardasil is one of Merck's top products and may generate $4 billion and 14 percent of Merck's earnings by 2012, according to JPMorgan Chase & Co. analyst Chris Schott."



Mas...

"Llegó el autobús": CERVARIX (ahora ya para mujeres)/ GARDASIL (ahora ya para hombres)...

“Cervarix is approved in many markets outside of the U.S. already” where it has “approximately 35 percent sales market share,” said Tim Anderson, an analyst at Sanford C. Bernstein & Co. in New York, in a note to clients last week. “In the U.S., the product will be roughly three years behind Gardasil’s introduction, and our belief is that it will not capture as much share in the U.S. as it has internationally.”

.../...

The FDA is scheduled to make a decision by the end of this month whether to approve Cervarix’s use in women ages 10 to 25. The shot is cleared in 98 countries and had sales of 125 million pounds ($232 million) last year, or about one-sixth as much as Gardasil. The average estimate of three analysts surveyed by Bloomberg calls for sales of 758 million pounds in 2012.

.../...

Merck had sought approval to sell Gardasil to prevent pre- cancerous lesions in boys and young men, as well as genital warts. The FDA told the company in May the proposal for prevention of “external genital lesions” was too broad, according to the FDA’s staff review.

This restriction may hurt Merck’s ability to prove the shot is cost effective for boys, said Keyur Parekh, a UBS AG analyst in New York, in a Sept. 4 note to clients.

Ver...

MERCK navega GARDASIL por aguas prohibidas...?

Oct.17 (Bloomberg) Merck&Co is targeting its cervical cancer vaccine Gardasil to women who may not benefit from it after U.S. sales shrank in July and August.

The number of Gardasil vaccinations tumbled more than 33 percent in those two months from the year-earlier period, according to health research firm IMS Health Inc. Merck shifted its marketing to women ages 19 to 26, who have been less likely to get the shots.

Mas...

GARDASIL: no, pero si...

Study examines cost-effectiveness of Gardasil

August 21, 2008

By John Carroll

Mas...

Un nuevo estudio publicado en NEJM cuestiona el "cost-effectiveness" de Gardasil en mujeres mayores (>26 años) pero si justifica su uso en pre-adolescentes.

Otras entradas...

Gardasil vs Cervarix: En un mes se conocerán resultados...

April 22 (Bloomberg) -- GlaxoSmithKline Plc will release the first study to compare its cervical cancer vaccine with Merck & Co.’s blockbuster Gardasil, more than a year after completing the research.
.../...

It will be presented for the first time at a medical meeting in Malmoe, Sweden, on May 10, according to a draft of the program obtained by Bloomberg News. .../...

The study also will help governments determine which of the vaccines to select for immunizing women, influencing a global market that Glaxo estimated at more than $10 billion last year. Glaxo’s shot, used less often than Gardasil in Europe, hasn’t won approval in the U.S., where Merck began selling its version three years ago.

Mas..

Y que ocurrirá con "aquellos" que ya decidieron si el resultado no confirma su decisión?

GARDASIL/CERVARIX: Portugal tambien...

Portugal tem registo de 21 casos de reacções adversas de jovens que tomaram a Gardasil, vacina contra o vírus do papiloma humano, metade das quais são consideradas graves.

As notificações não se limitam a um lote específico da vacina e abrangem mesmo as duas marcas no mercado, ou seja, Gardasil e Cervarix.

GARDASIL: Parece no ser cosa para varones...

Harvard University researchers have found that public health authorities would do better to extend the vaccination of adolescent girls against human papillomavirus (HPV) than to launch a campaign to get boys and young men vaccinated as well. The study, published in the British Medical Journal, comes as the Food and Drug Administration considers a proposal from Merck, the makers of the HPV vaccine Gardasil, to approve the vaccine for boys between the ages of nine and 15. (Más...)

By Julie Steenhuysen CHICAGO, Oct 8
Vaccinating boys against the virus that causes cervical cancer and genital warts does not appear to be cost-effective, U.S. researchers said on Thursday.

Assuming all girls get the shot, adding boys to a national vaccination program may not be worth the expense, they said. (Más)

Brasil aprova vacina Gardasil® contra HPV em homens

27/05/2011

A Anvisa (Agência Nacional de Vigilância Sanitária do Brasil) aprovou o uso de uma vacina contra o HPV (papilomavírus humano) em homens de nove a 26 anos de idade. O produto já era aplicado em mulheres, avança o site noticioso R7.

O objectivo da vacina, chamada Gardasil®, é prevenir os homens de verrugas genitais causadas pelos tipos 6,11, 16 ou 18 do HPV. Em Março, foi divulgado um estudo realizado no Brasil, México e EUA que indicou que cerca de 50% dos homens estão infectados com o HPV.

O Brasil é um dos líderes mundiais em incidência de HPV – mais de 685 mil pessoas vivem com o vírus. A doença sexualmente transmissível, que é causada por relação sexual desprotegida ou contacto genital, é a quarta mais comum no país, com números acima dos casos de sida. (Ver)

GARDASIL/CERVARIX: Incognitas aun por aclarar...

Incógnitas aún por aclarar

Todavía quedan lagunas en el conocimiento sobre la vacuna contra el virus del papiloma (VPH) que Miguel Ángel Martínez-González, Silvia Carlos y Jokin de Ira, del departamento de Medicina Preventiva y Salud Pública de la Universidad de Navarra, enumeran en un artículo publicado por Medicina Clínica. "Los ensayos que han usado lesiones clínicas como criterio de valoración no se han prolongado todavía más allá de cinco años", afirman. Aún se están realizando estudios sobre la vacuna.

Los autores añaden que "no obstante, es preciso reconocer que los valores de anticuerpos protectores que logra la vacunación son muy elevados".

Algunas de las dudas e incógnitas mencionadas por los autores son:

1. Se desconoce su eficacia y seguridad en un plazo mayor de cinco años.

2. No se sabe si se deberán usar dosis de recuerdo.

3. Se desconoce el mínimo valor de anticuerpos para obtener protección.

4. Falta información sobre la inmunogenicidad cruzada con otros tipos de VPH.

5. En niñas de 9-14 años no hay ensayos con lesiones (neoplasia intraepitelial cervical / adenocarcinoma in situ) como resultado.

6. No hay evidencia científica de reducción del cáncer invasivo.

7. No se ha presentado la eficacia estratificada por conducta sexual.

8. Se ignora si la infección por el VIH, la desnutrición u otros factores modifican la eficacia.

9. Hay dudas sobre su prioridad frente a otras vacunas o estrategias preventivas.

10. Se ignora si la vacunación masiva modificará los patrones de conducta sexuales, cuál será su impacto en el uso del preservativo y en los programas de cribado.

11. Se desconoce si las dos vacunas existentes (Gardasil y Cervarix) son intercambiables.

Mas...

Top 10 Pharmaceutical companies 2018 (III) IgeaHub

Ver anterior:
Top 10 Pharmaceutical companies 2018 (II)

 

Merck & Co. (U.S.)

Merck, research and development company, known as MSD outside the United States and Canada, offers health solutions through its prescription medicines, vaccines, biologic therapies and animal health products. Merck offers medicines in oncology, fertility, neurodegenerative diseases, and endocrinology. 
In 2017, top 3 best-selling drugs include Januvia / Janumet, Keytruda, and Gardasil / Gardasil 9.

Novartis (Switzerland)

Novartis is a global healthcare company based in Basel, Switzerland. The company’s portfolio includes innovative biological therapies and pharmaceuticals in several disease areas including oncology, cardiology, neurology, immunology, eye care, generic and bio-similar medicines. 
In 2017, top 3 best-selling drugs include Gilenya, Cosentyx, and Glivec.

Gilead Sciences (U.S.)

Gilead is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines. Gilead Sciences focused on virology, hepatology, hematology, oncology, cardiovascular, inflammation and respiratory diseases. 
In 2017, top 3 best-selling drugs include Harvoni, Epclusa, and Truvada.

GlaxoSmithKline (U.K.)

GlaxoSmithKline is research-focused pharmaceutical company engaged in discovering, manufacturing and distributing pharmaceutical products including prescription medicines, vaccines and consumer healthcare. It offers medicines in cardiovascular disease, gynecology, diabetes, anti-infective, dermatology, and respiratory diseases. 
In 2017, top 3 best-selling drugs include Seretide/Advair, Triumeq, and Tivicay.

Amgen (U.S.)

Amgen Inc. is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California that discovers and develops innovative therapies in both biopharmaceuticals and small molecule drugs. 
In 2017, top 3 best-selling drugs include Enbrel, Neulasta, and Aranesp.

Sources: SEC filings, companies websites, and annual reports.