Pharmaguy's Insights Into Drug Industry News
185.8K views | +2 today
Follow
Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
Curated by Pharma Guy
Your new post is loading...
Your new post is loading...
Scooped by Pharma Guy
Scoop.it!

Doctors Urged to Forget Conversation with Parents About HPV Vaccination and Just “Announce” It’s Time To Do It!

Doctors Urged to Forget Conversation with Parents About HPV Vaccination and Just “Announce” It’s Time To Do It! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

OBJECTIVE: Improving provider recommendations is critical to addressing low human papillomavirus (HPV) vaccination coverage. Thus, we sought to determine the effectiveness of training providers to improve their recommendations using either presumptive “announcements” or participatory “conversations.”

 

METHODS: In 2015, we conducted a parallel-group randomized clinical trial with 30 pediatric and family medicine clinics in central North Carolina. We randomized clinics to receive no training (control), announcement training, or conversation training. Announcements are brief statements that assume parents are ready to vaccinate, whereas conversations engage parents in open-ended discussions. I.e., Some of the doctors received training to propose the HPV vaccine to parents like any other vaccine, automatically assuming parents were ready to vaccinate their kids. Other doctors were trained to engage in open-ended discussions with parents about the vaccine, while a control group received no training at all. HPV vaccination coverage was 5 percent higher in clinics where doctors presumed parents would opt for the HPV vaccine. The study’s authors say that strategy may be more effective because it allows parents to sidestep discussing sex — which can be a hang-up for some — but still lets parents ask questions if they choose.

 

A physician led the 1-hour, in-clinic training. The North Carolina Immunization Registry provided data on the primary trial outcome: 6-month coverage change in HPV vaccine initiation (≥1 dose) for adolescents aged 11 or 12 years.

 

RESULTS: The immunization registry attributed 17 173 adolescents aged 11 or 12 to the 29 clinics still open at 6-months posttraining. Six-month increases in HPV vaccination coverage were larger for patients in clinics that received announcement training versus those in control clinics (5.4% difference, 95% confidence interval: 1.1%–9.7%). Stratified analyses showed increases for both girls (4.6% difference) and boys (6.2% difference). Patients in clinics receiving conversation training did not differ from those in control clinics with respect to changes in HPV vaccination coverage. Neither training was effective for changing coverage for other vaccination outcomes or for adolescents aged 13 through 17 (n = 37 796).

 

CONCLUSIONS: Training providers to use announcements resulted in a clinically meaningful increase in HPV vaccine initiation among young adolescents.

Pharma Guy's insight:

Wow! This is a low in doctor-patient relationship. So many tactics have been proposed to increase HPV vaccination, but this seems to be the most anti-patient yet, even worse than blaming the parents (read “Merck Ad Blames Parents & Asks: ‘Mom, Dad, Did You Know’"; http://sco.lt/4wtOs5 and “Marketing Gardasil Vaccination in the Halls of Colleges & Universities”; http://sco.lt/87OFSj).

 

Also read: “More Parents Refuse Vaccination for Their Kids. Why? Not the Reason You Think”; http://sco.lt/8pIo65

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Merck Ad Blames Parents & Asks: "Mom, Dad, Did You Know"

Merck Ad Blames Parents & Asks: "Mom, Dad, Did You Know" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

On the heels of a recently renewed push by researchers and doctors to encourage HPV vaccinations, Merck--maker of market-leader Gardasil--is out with a new HPV awareness campaign that puts the onus of vaccination on parents.

 

In the TV ad, a young adult woman with cancer caused by HPV is shown in a series of pictures that go back in time. She wonders whether hier parents just didn’t know about the vaccine that could have protected her when she was 11 or 12. “Mom, Dad, Did You Know?”, she says poignantly. The ad ends with a female voiceover asking, “What will you say?”

 

Most recently, an analysis of 58 studies on the vaccine since 2007 was compiled and evaluated, led by Royal Women’s Hospital at the University of Melbourne, Australia. It found a 90% decrease in HPV cases in countries with the highest vaccination rates, even though the HPV shot still lags other childhood vaccinations. In the U.S., only 40% of girls and 21% of boys have received the HPV vaccination, according to the CDC.

 

Gardasil brought in $1.9 billion in sales last year--which would sound like more if forecasts hadn't once pegged the HPV vaccine market at $4 billion in annual sales. The other HPV vaccine, GlaxoSmithKline's Cervarix, had sales of about $128 million last year.

 

The Merck spokeswoman said the awareness campaign is needed because in its own survey of 858 parents last year “about 85% were familiar with HPV, but only about 50% knew about the link between the virus and cancer.”

Pharma Guy's insight:

Dr. Dalbergue, a former pharmaceutical industry physician with Gardasil manufacturer Merck, said: "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."; http://sco.lt/4l3oe1 

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Is Gardasil a "Flop" Because of Faulty Investigative Reporting or Because of Social Media?

Is Gardasil a "Flop" Because of Faulty Investigative Reporting or Because of Social Media? | Pharmaguy's Insights Into Drug Industry News | Scoop.it
The Toronto Star, Canada's highest-circulation daily newspaper, has built a reputation for excellent investigative reporting, including justly celebrated exposes of Toronto Mayor Rob Ford.


But now that reputation is in tatters, due to an evidence-free "investigation" of the health risks of the vaccine Gardasil, which immunizes against the dangerous human papillomavirus. The Star's Feb. 5 piece, ominously headlined "A wonder drug's dark side," exploited heart-wrenching family anecdotes of illness and death to undermine a vast library of scientific studies proving the vaccine to be safe.


Worse, the Star responded to an uproar over the article by scientific and medical experts by smearing and demeaning critics -- until the paper's publisher finally acknowledged publicly that the story was wrong: "We failed in this case. We let down. And it was in the management of the story at the top," he told a radio audience on Feb. 11. On Friday, the Star added a subheadline to the online version of the article, acknowledging the uproar and stating in part, "There is no scientific medical evidence of any 'dark side' of this vaccine."

Pharma Guy's insight:

 

Meanwhile, some think social media is to blame. Read the following excerpt from a comment to "Will Social Media Make it Harder for Pharma to "Hide" Drug Side Effects?", a Pharma Marketing Blog post:

 

"Why was Gardasil a flop? It flopped because girls told each other via social media that they felt like $#^& after getting the shot. Not only is uptake in general low but the percentage of girls who get one shot and don't finish the three dose series is astronomical. Social media is killing Gardasil. People won't put up with feeling terrible for some theoretical protection thirty years down the road against something that may never happen to them anyways. Parents won't watch children suffer for the same reason. When they thought their child's adverse reaction was the proverbial "one in a million", they put up with it. Once they began to network (and read the package inserts) and realized how common these adverse reactions really were, parents started saying no. More an more say no every year.

"Pharma can't put the genie back in the bottle. They once controlled the flow of information as the mainstream media wouldn't jeopardize their pharma advertising revenue with critical stories. Blogs, facebook, twitter, etc. have broken the gatekeepers stranglehold on information. It's already happened with vaccines, and it will also happen with traditional drugs. The only reason it hasn't fully happened yet is that the primary market (senior citizens) aren't as plugged into social media as younger consumers. That's changing and it won't be good for pharma."

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

GSK Withdraws HPV Vaccine Cervarix from US Market

GSK Withdraws HPV Vaccine Cervarix from US Market | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Facing “very low market demand,” GlaxoSmithKline has decided to pull out of the U.S. market with the HPV vaccine Cervarix, a spokesperson told FiercePharma. It’s a move that gives Merck a stranglehold on the market as public health officials work feverishly to boost vaccination rates.

 

GSK’s last shipments were made on Aug. 31, according to a supplier note to customers. Last year in the U.S., GSK’s vaccine earned just £3 million of an £88 million ($107 million) worldwide total. That’s in comparison to Merck’s global total of $1.9 billion for the Gardasil franchise.

 

The move gives Merck complete control of the U.S. HPV vaccine market as public health officials push for higher HPV vaccination rates. A sex stigma, safety concerns, antivaccine campaigns and other factors have hindered uptake for a vaccine class once anticipated to reel in $4 billion to $10 billion by optimistic analysts.

 

CDC figures last year placed HPV vaccination rates at 40% for girls and 21% for boys, far short of a U.S. Department of Health and Human Services goal of 80% for both boys and girls by 2020.

 

To combat the low rates, organizations including ASCO and the National Cancer Institute have urged more vaccinations. In a joint statement, NCI’s cancer centers called the vaccines “tragically underused.”

 

Merck, for its part, launched an ad campaign to put the onus on parents to get their children vaccinated (read “Merck Ad Blames Parents & Asks: ‘Mom, Dad, Did You Know’").

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Marketing Gardasil Vaccination in the Halls of Colleges & Universities

Marketing Gardasil Vaccination in the Halls of Colleges & Universities | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Wandering the halls of a college or university campus can be enlightening in seeing how the pharmaceutical marketing machine is insinuating itself into the lives of young people.

 

Last month, while giving a public lecture at the University of Victoria, I spotted a glossy poster entitled, “Reasons Why You Should Help Protect Yourself Against HPV.” It featured a man and two women staring provocatively into the camera. Since consumer-directed advertising of pharmaceuticals is illegal in Canada, I wondered what this drug ad was doing on a university bulletin board.

 

No doubt designed to entice university students of both genders to start worrying about something they’ve probably never even heard of – HPV (Human Papilloma Virus) – it included this bold stat that helpfully stokes fear: “It is estimated that 75% of sexually active Canadians will have at least one HPV infection during their lifetime.” After making the link between HPV, cervical cancer and genital warts, the poster hits the students with the sales hook – I’m paraphrasing here – “Come on down and get your Gardasil 9 vaccinations and your student health plan will save 80% of the cost!” For debt rattled students, the chance of saving $400 must surely be very enticing because, well, genital warts? Oooh, gross.

 

The grossest thing about this poster was the missing safety information related to the vaccine. But if you looked closely, you could see it had been covered up, as was the manufacturer’s name, Merck, with a sticker showing the potential cost savings. The headline “Gardasil is available at UVIC Health Services for Men and Women” was followed by how the three-dose regime of the Gardasil 9 vaccine would cost students $480 out of pocket but only $96 with their undergraduate Extended Health Plan. What a bargain!

 

If you held the poster up to the light, you could just make out the safety information. In this case, the vaccine was related to a number of minor things and the classic cover-all statement, “As with any medicine, there is a very remote chance of a vaccine causing a serious injury or death.”

 

In my world of researchers, the university’s attitude seems quaint and naive given that many people worldwide consider the HPV vaccines to be poster children for “controversial.” Even though it’s designed to prevent infection by some strains of the sexually transmitted human papillomavirus (HPV), the vaccine has yet been proven to reduce cervical cancer rates. And the potential for harm is real and troubling.

 

Evidence from the company-sponsored, randomized trials used to approve the vaccine have shown it was generally safe, but ‘real world’ experience has been very different. In the US, for example, up to the end of September 2015, there were 37,474 adverse reaction reports made to the federal Vaccine Adverse Events Reporting System (VAERS) associated with Gardasil. These reports include 209 deaths. What does one make of this? It’s unclear because these deaths are deemed ‘associations’ and one cannot conclude the vaccine alone was directly responsible.

 

[The author, Alan Cassels is a drug policy researcher in Victoria. His most recent book, The Cochrane Collaboration: Medicine’s Best Kept Secret, has just been published. Follow him on twitter @AKECassels]

more...
No comment yet.
Scooped by Pharma Guy
Scoop.it!

Former Merck Doctor Predicts that Gardasil will Become the Greatest Medical Scandal of All Time

Former Merck Doctor Predicts that Gardasil will Become the Greatest Medical Scandal of All Time | Pharmaguy's Insights Into Drug Industry News | Scoop.it

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!


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.


As we have reported in many previous articles here at Health Impact News, the HPV vaccine has become a huge international controversy, while enjoying widespread mainstream media and medical acceptance here in the United States. Any mainstream media reporter who dares to report on the controversy surrounding Gardasil faces ridicule and a potential loss of their career. (Just ask Katie Couric.)


U.S. law prevents anyone from suing Merck or any other vaccine manufacturer as the U.S. Congress gave them total immunity from civil lawsuits in 1986, and that legal protection which gives them a free pass to put as many vaccines into the market as they want to, was upheld by the U.S. Supreme Court in 2011. In addition, the National Institute of Health receives royalties from the sales of Gardasil.

Pharma Guy's insight:


Back in 2009, I reported that Merck's cervical cancer vaccine, GARDASIL, posted total sales as recorded by Merck of $262 million for the first quarter of 2009, a 33 percent decline from the same quarter in 2008. Read more on that here.

It was speculated at the time that as more girls get the shot, its remaining market declines. Merck must target increasingly larger populations -- so Merck sought and got approval for use of Gardasil in boys (see here).


Gardasil's difficulties  include price, effectiveness, and possible dangerous side effects (the CDC said it has received reports of 21 deaths and almost 10,000 side effects in women following vaccination as of 2008.). Read more on that here.

more...
No comment yet.