Merck To Text Teens About Gardasil Reminders?
17 CommentsBy Ed Silverman // June 11th, 2008 // 1:28 pm
The drugmaker is urging docs to distribute a spiffy new brochure after administering the HPV vaccine in hopes teens and women will return for their second and third shots. However, the brochure, which is part of Merck’s ‘3 Is Key’ campaign, is worded in such a way that the drugmaker may wind up collecting personal info from teens that could be used for market research.
We’ve included a link to the brochure, so you can judge for yourself. Here’s what we see: the brochure asks for personal data - name, address, birth date and e-mail addess - as well as a signature, but doesn’t stipulate that a parent or legal guardian must sign, instead of the teen. There’s also a line indicating the personal data will be used for ‘market research purposes.’
As one mom, who asked not to be named, pointed out, the brochure is worded in such a way that a teenager reviewing the form may unwittingly provide Merck with personal info that can be used for market research. Of course, this assumes a doctor’s staffer handed the form to the teen, not the parent, or the parent gave the form to the teen, perhaps unaware of the entire content.
A Merck spokeswoman was unable to say why the signature requirement is open-ended (the language says: ‘If you are unable to sign, a legal representative, or parent - if you are a minor - may sign on your behalf.’) She also says the market research has an opt-out provision and is only going to be used to determine whether regular mail, e-mail or texting is the best way to issue reminders. But that’s not clear - the wording says ‘market research purposes,’ suggesting broader use may occur.
One ethics expert questioned the approach. “Compliance is a huge problem and should be pushed on all fronts,” says Art Caplan, who heads the Center for BioEthics at the University of Pennsylvania. “But reminders should never be used for market research. If a minor were to see that, I don’t think they’d understand what it means. It’s not the right place to do it.”
Paul
Based on my knowledge and understanding of this disease and vaccine, I don’t have much of a problem with this program.
My daughter falls into this population category and this seems like good education to have.
Chris
What is the concern with using the information for market research purposes? All that typically means that is that a participant can be contacted to participate in surveys or focus groups. Given that there would be no obligation to participate in the research, the only concern that I could see would be that somebody would be aware that they (presumably) received the vaccine. The personal information would still fall under standard market research confidentiality guidelines.
However, I am puzzled by the comment from the Merck spokesperson that the data was only going to be used to determine the best way to contact a given person. Because this response is specific to the person involved, it typically would not be considered a ‘market research’ use.
Ed Silverman
Hi Chris,
That may be the case, but given that Merck used imprecise language and wants to use some info specific to individuals, it’s hard to know what will occur. The approach seems too hazy.
Thanks for writing in,
ed
Perks
It should be made clear that a parent must sign.
By October 2007 there were 11 deaths and 3,461 negative reactions reported to the FDA as connected to the vaccine, with additional reports in Europe. Teens have no experience at determining the difference between the content of spiffy brochures and the realities of drug reactions.
Doug Bremner MD
Gardasil protects against the Human Papilloma Virus (HPV), a virus that is spread by unprotected sexual intercourse that affects more than half of the population. For 95% of people, however, they are asymptomatic and
never know they have an HPV infection. Although almost all cases of cervical cancer are caused by HPV, since HPV is so ubiquitous it is uncommon for HPV to progress to cervical cancer. Cervical cancer kills 4000 women per year. By my calculations, that means that about 0.002% of women infected with HPV die each year from HPV-induced cervical cancer—not a very impressive number.
However, you could be the one saved, in which case it would be well worth it.
Good point though, if there is any risk at all given the meager benefit there should be true informed consent. And certainly not mandated, as it was in Texas, secondary to a rife COI there.
Perks
Good point.
Over what time period did the trials take place?Were they followed up over decades? If not, how do Merck KNOW for sure that this vaccine will protect against cancers at a later date?
In the meantime, when Teens die or suffer serious reactions to the vaccine such as paralysis, Guillain-Barre Syndrome, or seizures, what assurance do we, or they, really have that their reactions were ‘not in vain’ ?
Doug Bremner MD
We don’t know what the long term effects of Gardasil are. Some of the downsides (death, paralysis, fainting) were not previously anticipated. It is not clear to me at all what the relative risk-benefit ratio is. It is clear that the benefit v risk, if any, is not as great as people think. That didn’t stop our pediatrician from popping a gardasil shot into my daughter’s arm without my even knowing it. I guess in this case her mother’s consent was enough. But to illustrate the point her mother wasn’t aware of the true risk-benefit ratio.
Laurie
“What is the concern with using the information for market research purposes? All that typically means that is that a participant can be contacted to participate in surveys or focus groups. ”
These are minors who should NOT be solicited for market research without their parents knowledge.
Nathan
Doug,
Are you aware of the risk-benefit ratio for the chicken pox vaccine? Just wondering…
This will open up a can of worms — but remember that manditory vaccines are NOT about the risk-benefit ratio of the individual. They are about the risk-benifit ratio of SOCIETY. Polio and smallpox vaccines have taught us that (as a society) we can essentially eradicate particular diseases. In my opinion, if we can eradicate a disease that kills ~4000 people per year, we should do it. 4000 people may seems like a small number to you. Only 3000 people died on 9-11. It seemed like a huge number at the time. We’re talking about 4000 people EVERY YEAR — year, after year, after year. We CAN eliminate this desease — and we should.
(clarification: we can eliminate 2 isoforms of the disease with current vaccines — that accounts for 70% of the 4000 annual deaths)
Nathan
BTW, just so you don’t think I’m hypocritical about this:
I have two young daughters. I’m a conservative Christian and like most Christians I will teach them abstenence until marriage. But I’m still going to get them vaccinated for HPV. Why? I don’t want one of them to die of cervical cancer due to some poor judgement she made in the back seat of car after a football game.
And, no, I don’t work for Merck.
Paul
Nathan,
Same here.
Dan
I worked for Merck way before Gardasil came about, yet I feel this way about any drug, vaccination, or injection: It should never be enforced by anyone except an agreement between an unaffiliated doctor and a patient regarding these matters.
If you do your homework, you’ll find that children were injected with awful medications and even diseases on occasion by force and with intent, and we should not allow this to happen ever again.
harpy
Typically when I need a follow-up visit the receptionist schedules it before I leave the office and I get a reminder call a day or two before I’m due back in. Merck may have good intentions with this program, but it still seems shady to me. I wouldn’t fill it out.
Nathan - in addition to abstinence I do hope you teach your daughters about birth control, and by this I mean condom use, because there are far more immediate consequences they could suffer from poor judgment in the back seat after a football game. Condoms don’t protect against everything, but they’re better than nothing.
how about the truth
Nathan,
No one wants anyone to die from cervical cancer, but you’re not guaranteeing that your daughter won’t get cervical cancer just because she gets Gardasil. Why? First, because it only protects against the viruses that cause about 70 percent of cervical cancer — meaning she still can get the other 1/3 that can lead to cancer. And, she still has to get her Pap tests, or she might get cervical cancer anyway from those other 1/3. Second, the other thing Merck isn’t telling you is that if you just so happen to be positive for the HPVs against which the shot protects at the time you get the shot, it does NOT work — it has ZERO percent efficacy then! So, until they approve some kind of test for HPV that can tell you whether you’re positive for the HPVs Gardasil protects against before you get the shot, you may or may not be protected, especially since you don’t necessarily have to have been sexually active to acquire HPV. Oh, yes, sex is the primary way that it’s spread. But not the only way. Educate yourself more about what HPV is and how it’s spread, and about what this vaccine does or does not do. Then decide what to do for your daughter. P.S. I am NOT anti-vaccine. My kids, who are now grown, did have all their shots.
punter
Gardasil is, quite possibly, the greatest scientific fraud in history (and it has some great competition). When they evaluated the vaccine for safety, they asked the FDA if they could give the ‘placebo’ recipients injections of an undisclosed amount of aluminium instead of saline. The FDA, astonishingly (astonishing if you don’t know much about the FDA that is), agreed. Lo and behold, the ‘placebo’ recipients had only slightly less significant adverse reactions than the Gardasil recipients. Conclusion: The vaccine was safe.
This experiment is equivalent to me giving 100 kids cyanide and 100 kids ‘placebos’ containing arsenic, noting that deaths occurred in 100 per cent of both the control and trial groups, therefore, cyanide was safe.
As astonishing as this is, you can look for yourself on the web for the study at http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf
Shannon
Where were the trials conducted for this product….fast tract from abroad?????
Justin Bentley
I am so glad to live in a free country where drug makers can bend & break rules. You know what I find really hilarious about the US? A batch of tomatoes makes a lot of people sick so all the tomatoes are immediately recalled. On the other hand, a moneymaking worthless drug like Gardasil that is left on the market after nearly 4000 bad reactions and 11 deaths.
Go Merck!!!
You know what my vote is? Let’s let it kill 100 poor unsuspecting teens. How about 1000? I mean, what number of children must we kill before anyone gives a rats ass about them and recalls this ridiculous drug that is marketed like a wolf in sheep’s clothing.
The United States is an absolute joke. The FDA is an atrocity. I think we are the laughing stock of the free world.
Any Merck executives who give a crap can give me a call at my office anytime so I can give you some advice on how to run an honest business. You have my information.
By the way, I am selling all my Merck stock and encouraging all of my friends and customers to do so.
Thank you,
Justin Bentley
National Sales Director
Telcom National