FDA OKs Merck’s Gardasil For Two More Cancers
31 CommentsBy Ed Silverman // September 12th, 2008 // 8:46 pm
Perhaps this will fan the controversy over the HPV vaccine still more. In any event, the agency expanded Gardasil’s approved uses to include cancer of the vagina and vulva, but at the same time added new info to the prescribing label about reports of deaths and illnesses.
Overall, though, the move gives Merck a boost over Glaxo, whose Cervarix HPV vaccine was delayed last year by the FDA. Gardasil was approved to protect females ages 9 to 26 against four strains of HPV, which can cause up to 70 percent of cervical cancers and 90 percent of genital warts. Docs, however, have needed incentives and Wall Street is disappointed with Gardasil revenue.
You may recall that a recent study found Gardasil makes economic sense for preteens because they are less likely to have the sexually transmitted virus that causes cervical cancer, according to the study. But the cost-benefit depends on how long Gardasil’s protection will last, and is uneconomical for women over 18. Merck contends the vaccine is cost effective for women through age 24.
“There is now strong evidence showing that this vaccine can help prevent vulvar and vaginal cancers due to the same viruses for which it also helps protect against cervical cancer,” Jesse Goodman, who heads the FDA’s Center for Biologics Evaluation and Research, in a statement.
The added prescribing info includes reports of deaths, seizures, autoimmune disorders, and paralysis in patients given the vaccine, without indicating any link to the vaccine. In July, the Centers for Disease Control and Prevention indicated Gardasil was safe after reporting that 20 people died following the injection, but the deaths could be unrelated and no additional precautions were needed (look here).
Conservative groups, such as Judicial Watch, argue the vaccine is dangerous, maintain abstinence is a safer choice and object to mandatory vaccination.
Paul G
Perhaps it will fan more the controversy…and just perhaps people, especially relentless critics will realize that the benefit that this vaccine brings to public health is amazing. Not without risks, but would we rather have this thing pulled off the market like some people want?
NR
Paul give us scientific evidence how the benefit of this vaccine is amazing.
Please lay it out simply. Cites, science, not opinion.
Paul G
NR, have you not read all the data, the studies, the papers, the product information? Everyone of those studies has shown a big difference vs. placebo in just about all measures.
The idea of having a cancer vaccine alone is an amazing one, and here is a product that delivers on that idea.
laurie
“NR, have you not read all the data, the studies, the papers, the product information? Everyone of those studies has shown a big difference vs. placebo in just about all measures.”
There are also reports that they have no idea how long the “protection” will last, if boosters would be required and when, and then there’s the adverse reactions that are being reported when widespread use started.
The “studies” are short term effect with minimal long term data, hence the possible booster need.
And, just to point out, it’s not a “cancer vaccine”, it’s a vaccine against a virus that can potentially be cancer causing. Big difference.
Paul G
Laurie,
So what would you do if you have a teenage daughter like I do? Wait another 10 years until you have satisfying data? By then she may have contracted HPV (like 35% of kids will before they reach age 20).
BOB FIDDAMAN
Paul G,
Do you trust Merck, the manufacturers of Gardasil?
Simple question and one that requires only and yes or no answer.
Fid
Nathan
Laurie,
I’d also like an answer to Paul G’s question. You are right - there are no long term studies yet. Would you rather wait another 10-20 years till the studies are done?
I suppose you feel the same about other vaccines? Prevnar? How long of studies would you like to see on drugs? Remember our patent lifetime is 21 years. We can’t get a drug to market until 7-10 years into the patent life. If you want truely long-term studies to be done, you’ll need to completely revamp the patent/approval system.
(yes, I know — vaccines are a special case. As a biological, there is no current mechanism for companies to get generic approval. But as we all know, that will likely change soon.)
AA
Folks might want to read this relevant article in the Washington Times. Warning - it is long but I think is quite relevant to this controversy in my opinion:
http://tinyurl.com/5exqxk
Risk vs. reward
Dr. Mona Saraiya, a medical epidemiologist in the Division of Cancer Prevention and Control at the CDC, says nearly all sexually active woman are exposed to HPV.
“However, only a few will get an infection that stays and won’t go away, and only a portion of those will get a precancerous lesion. At that point, only a few will eventually develop cervical cancer,” Dr. Saraiya said.
Fewer than one-hundredth of 1 percent of the 108 million U.S. women older than 18 (0.009 percent) get cervical cancer and even fewer die from it. There were an estimated 9,700 new cervical cancer cases and 3,700 fatalities in 2006, according to the American Cancer Society.
So Paul and Nathan, to answer your question, if I had a teenage daughter, I would definitely not have her get the vaccine. According to these statistics, it would not be worth the risk of a vaccine that hasn’t established a good track record of safety.
Even if you think your daughter should get the vaccine, according to the article, any problems will show up in mostly older women who have long lost the protection period of the vaccine.
AA
laurie
“So what would you do if you have a teenage daughter like I do? Wait another 10 years until you have satisfying data? By then she may have contracted HPV (like 35% of kids will before they reach age 20).”
If I had a teenage daughter, I would teach her that annual cervical screenings are a vital part of her health needs. I would discuss the means of transmission of HPV and how to maximize protection of those transmission routes.
I am not “anti vaccine”….I am concerned with giving this vaccine to 8 year olds with no timeline for when this “protection” may stop working, and using this vaccine in very young children when we have no data on long term effects.
Paul G
Bob,
Do you want a simple answer? Yes I trust them.
In fact, I trust them a hell of a lot more than:
- Government
- Trial and plaintiff attorneys
- Blind and obsessed critics
BOB FIDDAMAN
Thanks for your honest answer Paul.
Do yourself and your daughter a favour before you decide on the jab though (unless you already have)
Type ‘Vioxx’ into Google.
Good luck in whatever decision you make… it’s a tough call.
Nathan
Laurie,
As for “when the protection may stop”, here’s something to think about. It’s the HPV that causes the cancer - right? Let’s say that the vaccine is only effective against the virus for a relatively modest 15 years (most vaccines are effective much longer than that). If you vaccinate at 12, she should be protected from HPV till 27. Considering that the 12-27 time frame is the most likely that she will contract HPV, I think she has been protected against a significant risk of HPV related cancer FOR THE REMAINDER OF HER LIFE — even if the HPV immunity wears off.
I have two young girls — I’ll get them both vaccinated when they reach the appropriate age.
Moreover, as I’ve brought up in previous conversations on this site, this vaccine (and its successors) give us the opportunity to ERADICATE a disease that results in 2000-3000 deaths every year. (does anyone get measles or smallpox anymore?) Pharma is constantly criticized for coming up with chronic treatments for disease rather than cures. This is even better than a cure — it is a true prevention of a deadly form of cancer.
Nathan
AA,
It’s a little funny to me that you think that 3700 deaths and 9000 case of cancer a year are somehow insignificant. If everyone in the US was innoculated with this vaccine, that would drop to ~3000 cases of cancer and only 1200 deaths. (the next generation vaccines will hopefully take those numbers even lower)
truthman30
Do you want a simple answer? Yes I trust them.
In fact, I trust them a hell of a lot more than:
- Government
- Trial and plaintiff attorneys
- Blind and obsessed critics
Anyone who trusts the pharmaceutical industry nowadays does so with blind naivety , that’s a sad state of affairs…
The industry should be held up as beacon of integrity and ethics, instead it it wallows in corruption, deceit and lies..
People can’t trust the industry because the industry can’t trust itself..
vince
Weather this product will protect against reduce the rates of cervical cancer is simply not know. Giving it to kids has been described as a public health experiment. The duration of this vaccine is unknown. Certainly anyone can choose to take this vaccine but to mandate it is not supported by the evidence
BOB FIDDAMAN
The Human Papilloma Virus (HPV) has no direct link to cervical cancer!
The FDA have known this since 2003.
Gardasil vaccines may increase the risk of developing precancerous lesions by 44.6% in some groups of women.
http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf
Still think it’s safe?
Nathan
Bob,
You’re funny. You are joking, right?
Here’s the FDA’s statement about HPV. Have a quick read.
http://www.fda.gov/WOMENS/getthefacts/hpv.html
By the way, thanks for the link you sent. It clearly demonstrates the safety and efficacy of this vaccine. Here’s the data of adverse events from 20,000 patients:
(the first number is the number of events on vaccine treated patients, the second is on placebo treated patients)
Gynecological or obstetricalL: 42, 41
Gastrointestinal: 11, 6
Appendicitis: 4, 1
Injury: 6, 6
Neurological: 4, 7
Immune mediated: 2, 4
Coagulation/DVT: 2, 1
Pulmonary: 2, 5
Genitourinary: 6, 3
Endocrine: 1, 0
Injection site reaction: 1, 0
Psychiatric: 5, 2
Cardiovascular: 1, 1
Musculoskeletal: 1, 1
ENT: 1, 0
Total: 101, 97
Lisa Van S
Nathan,
You appear to be an individual who is “pro- prevention”. According to child and adolescent Psychiatrists 1 in 6 children will have suicidal thoughts and many more will rcve a mental health diagnosis.
So my question to you is this. Would you consent, to your children being prescribed an antidepressant, or an antipsychotic, for the prevention of child onset mental illness?
Jack2
rcve?
Lisa Van S
receive?
Jack2
Do you have a reference that >1/6 children receive a mental health diagnosis. I can’t believe that.
BOB FIDDAMAN
Nathan, you may want to read this:
http://www.naturalnews.com/022404.html
I think it’s best if we know ALL the facts and not just what Pharma want us to hear.
Nathan
Bob,
Did you read the report? The report is based largely upon this FDA press release: (page three of the “naturalnews” report)
http://www.fda.gov/bbs/topics/NEWS/2003/NEW00890.html
Please read the FDA press release yourself and see if you come to the same conclusion. I certainly didn’t. Here’s a quote from the FDA press release that supposedly indicates that the FDA believes that HPV and cervical cancer are not linked:
“The HC2 High-Risk HPV DNA Test, manufactured by Digene Corp., of Gaithersburg, Md., can identify 13 of the high-risk types associated with the development of cervical cancer. The HPV DNA test does not test for cancer, but for the HPV viruses that can cause cell changes in the cervix. If left untreated, these changes can eventually lead to cancer in some women.”
So, technically, you are absolutely correct. HPV doesn’t cause cancer. Rather, HPV causes cell changes in the cervix which, left untreated, eventually lead to cancer in some women.
Wow - what a stunning revelation… I guess technically smoking doesn’t cause lung cancer either. Rather, it causes “changes in lung cells which, left untreated can lead to lung cancer in some smokers.” Good luck with that arguement. I wouldn’t start smoking again if I were you.
Lisa Van S
Jack2
Dr. David Fassler(Child and Adolescent Psychiatrist) has testified before FDA and has given many media interviews on this. Please google his name and read for yourself, So I may be able to stay unbiased.
Nathan
Lisa,
Two links I ‘ve found with his testimony say nothing of the sort:
http://www.politicalwatchdog.com/psych_fraud/fassler.htm
http://www.aacap.org/cs/root/resources_for_families/psychiatric_medication/children_and_ssri_antidepressants_information_for_parents_by_david_fassler_md
Lisa Van S
Nathan,.
FDA conducted a two day hearing on medication Guides.June12th and 13th. Dr Fassler’s testimony can be found at the end of the hearing on June 13th. How do I know? I sat beside him. I also noticed you never answered my question,.. would you allow “your children” to be treated with psychotroppic drugs to prevent mental illness? Maybe more important than HPV?!!!!
AA
Nathan,
You took what I said out of context. Here is the whole exert:
Fewer than one-hundredth of 1 percent of the 108 million U.S. women older than 18 (0.009 percent) get cervical cancer and even fewer die from it. There were an estimated 9,700 new cervical cancer cases and 3,700 fatalities in 2006, according to the American Cancer Society.
Don’t infer things that aren’t there as I didn’t say these deaths are insignificant. One death is one death too many.
My point was that because of these statistics, a vaccine that doesn’t have a proven safety record is a big gamble and tilts the risk/benefit ratio greatly towards the risk section.
I saw your post about reported side effects to the FDA. But if it is anything like with drugs in which it is estimated that only 1 to 10% of all AEDs are ever reported, I would tend to not trust those figures.
Anyway, do you have a link to unbiased research showing the vaccine would reduce the fatalities and cancer rates to back up your claim?
AA
laurie
” Let’s say that the vaccine is only effective against the virus for a relatively modest 15 years (most vaccines are effective much longer than that). If you vaccinate at 12, she should be protected from HPV till 27. ”
Nathan, if these were documented claims, then I wouldn’t have such a problem with that aspect. But I’ve heard anywhere from 4-6 years immunity.The one scientist who worked on this vaccine pointed out that this is a potentially big problem.
So if we’re vaccinating 8 year old, that puts them at 12-14 years when that immunity is no longer there. This is one of the problems I have with this. No one appears to know when this will wear off, so what do we tell these kids when they hit their teens, at the highest risk point.
Now tack on the adverse reactions and there’s enough for me to question it’s use.
Of course it’s an individual decision for a parent and child to make, but not having full disclosure, once again, leaves a parent making a decision on only partial information.
truthman30
If I was to be a total cynic about this..
I would say this is the pharmaceutical industry, yet again,marketing the disease and then the drug to treat it..
These vaccines will be a major cash cow for the industry..
And is that not always the bottom line?
truthman30
Whenever I read the words “Blockbuster” and “GSK” in the same sentence, I shudder…
Paxil and Avandia were both promoted as wonder drugs, and they were also “blockbusters” for GSK..
They were also extremely dangerous and defective…
http://www.bioportfolio.com/cgi-bin/acatalog/GSK_s_Cervarix_a_future_blockbuster_of_2007.html
GSK’s Cervarix a future blockbuster of 2007
The number of blockbusters continues to increase. The number is set to increase to 112 in 2007. Of the products set to receive FDA approval this year and generate blockbuster status on an annual basis, GSK’s Cervarix, intended for the prevention of infection and lesions from the two cancer-causing types of HPVs holds great potential.
GSK will earn royalties of up to 10% or $200 million each year from Merck due to sales of the Cervarix cervical cancer vaccine, according to the legal settlement reached last year. This is a new market battle and you need to be part of it.
harpy
I think this “In any event, the agency expanded Gardasil’s approved uses to include cancer of the vagina and vulva” is misleading - aren’t they really linking HPV to the cause of vaginal and vulvar cancer?
To put it another way - it is still only preventing (arguably) the same four strains of HPV that cause an estimated “70 percent of cervical cancers and 90 percent of genital warts.” Asking what percentage of vaginal and vulvar cancer is caused by HPV is almost beside the point (but still worth knowing).
I call shenanigans on the FDA - if this were a DTC ad, they would be investigating misleading claims. In my mind, it’s akin to saying Chantix prevents lung cancer. And it really doesn’t give Gardisil any more of a leg up on Cervarix than it already has - the way I read it, if it prevents the same strains, it’ll have the same indications, no?