© copyright 2007 Betsy L. Angert
Please view this Gardasil Commercial. Contemplate the truer concerns.
On February 3, 2007, I expressed my distress in an exposé titled, Texas Mandates STD Vaccination for Elementary Age Schoolgirls. In my writing I discussed the executive order imposed by Texas Governor Rick Perry. This Christian conservative concluded young schoolgirls, ages eleven and twelve, must be inoculated against cervical cancer. A series, of three shots, each costing $120 would be required. The consumer would be forced to pay for this state-imposed immunization. Actually, the child would not, or could not possibly purchase such services. Parents would bear the financial burden. The young girls might carry another costly load. Drugs have side effects. The more effective Pap Smears do not. Nonetheless, profits are on the line. I know, you thought saving lives was the greater concern.
Granted, mothers, fathers, or guardians could opt out of the program, if they think to do so. However, there is a stigma associated with nonconformity. A parent may be labeled negligent or a religious zealot. Few will think a concerned custodian is doing what is right, moral, or ethical if they are not protecting their young daughters from cervical cancer.
When I first learned of this story there were many questions, numerous concerns, and too few answers. I speculated. I investigated. I determined Governor Perry had close ties with the Pharmaceutical distributor. I postulated. This plan is profitable; it is not necessarily prudent.
Nevertheless, state officials in some twenty other regions are considering similar measures. In my own home state of Florida Gardasil injections may soon be mandatory. The drug company, Merck has been lobbying lawmakers nationwide.
Weeks ago, hardly any one was assessing the facts. Although readers at BeThink.org were. I received many brilliant, insightful, and informed comments. I cannot thank stickdog and maggiemahar enough. Your wisdom and knowledge may have provoked a change in Merck policy. Perchance, your sharings stimulated those on the right, left, and in the middle. It seems more people are mindful. Individuals and groups are asking, 'What are we doing to our children in the name of science and safety?'
Today, there is more news on this topic. I will contrast this recent bulletin with the research stickdog and maggiemahar presented. I think you might find each assessment interesting. In fact, a review of all of these together might be truly enlightening. Much of what is not said in the official statement is stated in reader remarks. Please peruse each of these accounts and decide for yourself. Is Gardasil the optimal solution for a prevalent problem? Is cervical cancer a common occurrence. Might Pap smears be a more effective, preventative treatment? Will Merck terminate their lobbying, or only alter their operation.
Merck ending lobbying for mandatory Gardasil vaccineThe number of deaths seems compelling. However, when we assess the data, we must consider the word "worldwide." Too often when given a statistic we ignore the variance in situations. Health care standards in a third world country do not compare with those in the Western world. Numbers may skew an evaluation. Health care services provided for the poor, even within our own country are a source of concern. Perhaps we would be better served if we looked at all the facts and circumstances.
February 21, 2007
NEW YORK (Reuters) - Drugmaker Merck & Co. said on Tuesday it would stop lobbying state legislatures to make it mandatory for schoolgirls to be inoculated with its new cervical cancer vaccine.
The company said it made the decision after re-evaluating its lobbying program, which has generated fierce debate with some religious organizations saying it could encourage promiscuity and parents groups questioning the need for such a widespread vaccination program.
Merck's Gardasil is the first and only vaccine against cervical cancer. Approved in 2006 for females aged 9 to 26, it works against strains of the human papillomavirus (HPV), a sexually transmitted disease responsible for about 70 percent of cervical cancer cases.
Earlier this month, Texas became the first U.S. state to require that all 11- and 12-year-old girls be vaccinated against HPV. Republican Gov. Rick Perry said parents could opt out of mandatory vaccinations for their children if they objected for reasons including religious beliefs.
About 20 U.S. states had been considering mandating the vaccine, many for girls before they entered the sixth grade.
The vaccine, given in a series of three injections at a price of $360, has been endorsed by medical organizations such as the American Academy of Pediatrics.
In December, Merck said it was looking into providing Gardasil at much lower prices in developing countries and to make it available within months.
Richard Haupt, executive director of medical affairs for vaccines at Merck, said the media publicity had become a "potential distraction" that was interfering with the company's objective of promoting widespread use of the product.
"We've reevaluated our position, but certainly plan to continue education efforts in different venues, such as with legislators, health departments and coalition groups in various states," Haupt said.
The company reaffirmed it continues to expect combined revenue this year of $2.8 billion to $3.2 billion from its array of vaccines, including ones to prevent shingles and infections with rotavirus.
GlaxoSmithKline Plc is expected to file in April for U.S. regulatory approval for its cervical cancer vaccine Cervarix.
Cervical cancer kills some 300,000 women worldwide each year.
After reading the news report and Merck's contention we might reason that religion and the fear of promiscuity were influential in drug company's decision. However, I suspect there is a more persuasive argument. The facts presented in this statement are fascinating and perhaps profound. Nevertheless, they differ from the evaluation stickdog offers. Please read this text. I hope you will find it meaningful.
Stickdog studied the original research on Gardasil and found the conclusions questionable.
The Facts About GARDASILStickdog submits more for your consideration.
1) GARDASIL is a vaccine for 4 strains of the human papillomavirus (HPV), two strains that are strongly associated (and probably cause) genital warts and two strains that are typically associated (and may cause) cervical cancer. About 90% of people with genital warts show exposure to one of the two HPV strains strongly suspected to cause genital warts. About 70% of women with cervical cancer show exposure to one of the other two HPV strains that the vaccine is designed to confer resistance to.
2) HPV is a sexually communicable (not an infectious) virus. When you consider all strains of HPV, over 70% of sexually active males and females have been exposed. A condom helps a lot (70% less likely to get it), but has not been shown to stop transmission in all cases (only one study of 82 college girls who self-reported about condom use has been done). For the vast majority of women, exposure to HPV strains (even the four "bad ones" protected for in GARDASIL) results in no known health complications of any kind.
3) Cervical cancer is not a deadly nor prevalent cancer in the US or any other first world nation. Cervical cancer rates have declined sharply over the last 30 years and are still declining. Cervical cancer accounts for less than 1% of all female cancer cases and deaths in the US. Cervical cancer is typically very treatable and the prognosis for a healthy outcome is good. The typical exceptions to this case are old women, women who are already unhealthy and women who don't get pap smears until after the cancer has existed for many years.
4) Merck's clinical studies for GARDASIL were problematic in several ways. Only 20,541 women were used (half got the "placebo") and their health was followed up for only four years at maximum and typically 1-3 years only. More critically, only 1,121 of these subjects were less than 16. The younger subjects were only followed up for a maximum of 18 months. Furthermore, less than 10% of these subjects received true placebo injections. The others were given injections containing an aluminum salt adjuvant (vaccine enhancer) that is also a component of GARDASIL. This is scientifically preposterous, especially when you consider that similar alum adjuvants are suspected to be responsible for Gulf War disease and other possible vaccination related complications.
5) Both the "placebo" groups and the vaccination groups reported a myriad of short term and medium term health problems over the course of their evaluations. The majority of both groups reported minor health complications near the injection site or near the time of the injection. Among the vaccination group, reports of such complications were slightly higher. The small sample that was given a real placebo reported far fewer complications - as in less than half. Furthermore, most if not all longer-term complications were written off as not being potentially vaccine caused for all subjects.
6) Because the pool of test subjects was so small and the rates of cervical cancer are so low, NOT A SINGLE CONTROL SUBJECT ACTUALLY CONTRACTED CERVICAL CANCER IN ANY WAY, SHAPE OR FORM - MUCH LESS DIED OF IT. Instead, this vaccine's supposed efficacy is based on the fact that the vaccinated group ended up with far fewer cases (5 vs. about 200) of genital warts and "precancerous lesions" (dysplasias) than the alum injected "control" subjects.
7) Because the tests included just four years of follow up at most, the long term effects and efficacy of this vaccine are completely unknown for anyone. All but the shortest-term effects are completely unknown for little girls. Considering the tiny size of youngster study, the data about the shortest terms side effects for girls are also dubious.
8) GARDASIL is the most expensive vaccine ever marketed. It requires three vaccinations at $120 a pop for a total price tag of $360. It is expected to be Merck's biggest cash cow of this and the next decade.
These are simply the facts of the situation as presented by Merck and the FDA.
Merck and the FDA:
Alum Injections Cause Neural Death in Mice:
More On GARDASILAuthor Maggie Mahar contributes her thoughts to the discussion.
There are two sides to every discussion, of course. This vaccine does appear to confer some benefits. If I were a sexually active woman who disliked condoms and liked to have multiple sex partners who had not yet been exposed to any of the four strains of HPV that this vaccine protects against, I just might sign myself up.
But that's not the same thing as making this vaccine MANDATORY for a preteen population it was not rigorously tested on a scant 8 months after its initial rush job FDA approval.
Aside from all the known risks of all vaccines, the unknown risks of this three shot regimen for preteens along with their other vaccine load, and the unknown long-term risks of this vaccine for all populations, we have to look at cost vs. benefit.
7861 of the placebo subjects contracted 83 cases of HPV 6-, 11-, 16-, 18-related dysplasias during the testing period compared to 4 cases among the 7858 subjects who were given GARDASIL. That's after counting out every subject with any prior exposure to these strains. This includes 42 of the less serious HPV 6-, 11- related low-grade dysplasias.
Merck has published no data for how many non-HPV 6-, 11-, 16-, 18-related dysplasias were contracted by these subjects over these periods, but some practitioners have commented that they expect the vaccine to protect against 40%-50% of all dysplasias.
In terms of every possible kind of dysplasia for which this vaccine confers protection, Merck's own clinical evidence suggests that this vaccine saved about 10 patients out of each 1000 injected from the painful process of having these dysplasias treated (over the entire course of follow ups which ranged from 18 months to 4 years). Note that the populations for these studies were not preteens but women at the height of their sexual activity. Further note that since the vaccine uses virus-like particles (a new vaccine technology) and is only about five years in testing now, there is no guarantee that it has any long term efficacy.
Of course, the pre-teen population is so less sexually active (and when active, so much less likely to be active with a previously contaminated partner) that I think it would be conservative to estimate that preteens are 5 times less likely to contract HPV dysplasias than the 16 to 26 year olds who were tested by Merck. So instead of saving 10 women per 1000 from painful treatments for HPV dysplasias, this vaccine would save perhaps 2 girls per 1000 from these procedures among the much younger population that Merck and Merck's politicians are targeting for mandatory vaccination.
Do we really want to pursue a public policy that costs $360,000 to vaccinate every 1000 girls while exposing each and every one of these thousand girls to the known adverse short term and largely unknown long terms side effects of three injections of a new vaccine just to save two of the more sexually active of these kids from having to have their dysplasias treated conventionally?
What kind of a risk and cost vs. benefit trade off is that?
Note that nowhere are we discussing actual incidences of cervical cancer because there is no clinical evidence whatsoever that GARDASIL reduces cervical cancer rates, and even if we place our hope in the fact that it might, cervical cancer is simply not a meaningful health risk for any girl in the target vaccination population who is getting an annual pap smear.
While it is a widely accepted medical theory that HPV "causes" cervical cancer, it's not close to being a fact. Although the vast majority do, many cases of cervical cancer don't show any association with HPV. It's a very good guess that certain strains of HPV are necessary co-factors for certain highly prevalent types of cervical cancer to emerge. The two really bad strains protected for in GARDASIL go hand in hand with 70% of CURRENT cervical cancer cases. My point is that there are 36 nasty strains of HPV screened for currently, and the human body is an ecology. We have no idea how protection against the two strains of HPV that are CURRENTLY most prevalently associated with cervical cancer (typically decades after initial exposure) will affect overall cervical cancer rates far in the future.
What we instead DO know is that current practices of annual pap smears and screening for ALL bad strains of HPV continue to reduce rates of cervical cancer among the US population annually. If all US women received a pap smear every year and were then promptly treated for any abnormal growths encountered, both the cervical cancer contraction and mortality rates would plummet even further to the point where HPV-associated cervical cancer would kill no more than a handful of US women a year. Yes, that is a guess as well, but it's a far better guess than assuming that conferring protection against four of the myriad of current and future strains of harmful HPV will somehow do the trick.
Certainly GARDASIL's benefit data against the four strains of HPV it targets are compelling. HOWEVER, the benefit data against ALL forms of HPV are not published by Merck and estimated by OP-GYNs to be a mixed bag. The benefit data against cervical cancer itself are nonexistent. The long term risk data for any population are nonexistent. There are almost no risk data at all for pre-teens. The fact that the "placebo control" was a shot of alum that was recently shown to cause neural death in mice is particularly problematic in terms of interpreting the small amount of risk data that were gathered.
Studies of the long-term benefits of a new drug or vaccine take a long time. It would take several decades to prove conclusively that this vaccine prevents cervical cancer deaths. So why the rush to make these three injections COMPULSORY for preteens?
Perhaps this would be excusable if GARDASIL conferred protection against HPV generally, but it does not. We have absolutely no way of even guessing how conferring protection against four strains of HPV will affect cervical cancer rates decades down the line. If you do, please quantify the expected benefits in terms of the expected reduction of cervical cancer contraction and mortality rates for the population of US women who get annual pap smears. The only thing you can say about these numbers are that they are unknown and tiny.
I am not trying to stop anyone from signing up themselves or their kids for this. If you want to pay $360 to make your little girl one of Merck's test subjects, please do. As I said, the vaccine shows promise. It may be a life saver for a small segment of the population (especially those too poor or uninformed to get annual pap smears), and it offers protection against most genital warts and a good percentage of HPV dysplasias.
The procedures to remove these warts and dysplasias are very painful, so these benefits are compelling. However, the risk and cost vs. benefit profile of this vaccine is not such that it is good public policy to mandate it -- especially not for a pre-teen population on which it has never been sufficiently tested -- even with an "opt out" clause. If Merck wants to make sure that women and parents who want it and can't afford it can get it, they should offer it to low income individuals and families on a sliding scale rather than lobbying state and federal governments to pony up the billions.
Gardasil--Merck vaccineYou dear reader, may have thoughts to share? Has your personal experience helped you to understand the dynamics of this campaign. If so, in what ways? Please share your stories. Merck will spin their tale. I think it might be wise we articulate our anecdotes. Let us teach the children and their parents to protect themselves from profiteers, pronouncements, and promiscuity.
The fact that Merck's vaccine protects against only 70 percent of the viruses that cause cervical cancer is key.
Pap smears, by contrast, can detect nearly 100% of cervical cancers. This is why Merck itself acknowledges that girls who receive the vaccine still need to have regular Pap smears.
But given all of the hype about Gardasil there is a real danger that girls who receive the vaccine will think that they are now "safe" and don't need Pap smears. Last weekend NBC news interviewed a young girl in Texas who expressed relief that she had been vaccinated: "Now this is one cancer I don't have to worry about fighting." No one corrected her.
Merck has been pushing Gardasil and pushing hard--enlisting of help of organizations like Planned Parenthood (which receives large contributions from Merck) because the company desperately needs a new blockbuster drug. After being forced to withdraw Vioxx from the market Merck is financially strapped. See the Wall Street Journal's stories about the vaccine--the Journal makes it clear that this is a business story.
If Merck were primarily concerned with saving lives, it would make this vaccine available--at an affordable price--in the emerging world, where Pap smears are not readily available. Instead, it is charging $360, making Gardasil the most expensive vaccine ever manufactured.
Posted by: Maggie Mahar | Feb 10, 2007 10:46:29 AM
Refer to Resources . . .