Now that the FDA’s vaccine advisory panel has given the nod to Gardasil for boys and men, the FDA is almost certain to approve the new market.
Although several panel members expressed concerns about the unknown duration of Gardasil’s protection against four strains of the HPV virus, only one member voted no. That was Vicky Debold, PhD, RN, who is the panel’s consumer representative.
"It would be a mistake to go forward and recommend that boys be encouraged to take this vaccine,” Dr. Debold said, “until we understand what's going on with the safety issues that [are] cropping up in girls.”
The value and safety of Gardasil have been increasingly questioned of late, notably this month in JAMA. The FDA has warned that the vaccine demonstrably raises the risk of syncope and blood clots, although it believes that the potential benefits far outweigh the risks. Drs. Sheila and David Rothman noted in JAMA that there was no data available about the vaccine’s effect on natural immunity, replacement diseases, or human behavior, such as ditching annual exams. They questioned the assumption that defeating HPV strains 16 and 18 will lead to a marked reduction in cases of cervical cancer. And they expressed concern that consumers were pushed to get the vaccine without being given the unbiased information necessary to properly weigh risks versus benefits.
Meanwhile, the vaccine has been associated with various serious side effects, including neurological and autoimmune conditions, in a small percentage of girls who’ve received one or more doses of the vaccine. No link, however, has been demonstrated at this point. (On the bright side for the parents of boys, autoimmune disease, which can be triggered in susceptible individuals by environmental factors, is less common in males than in females.)
“I would love my daughter and my son to get a vaccination that would prevent any kind of HPV, but it has to be at no cost, and I don't mean financial cost, I mean at no health risk cost," Dr. Jacques Moritz, the director of gynecology at St Luke's Roosevelt Hospital, told CBS news.
For boys, the vaccine has fewer potential direct benefits than for girls. The FDA was asked to consider only its efficacy for preventing genital warts, which affect about one percent of the population. Although the human papillomavirus can cause anal, penile, perineal and oral cancers in men, such cancers are very rare and are not as directly traceable to HPV—only about 40 percent of penile cancers, for instance, are related to HPV. Many boys and men will get the vaccine mostly as a way of protecting future partners. That gesture that can only be applauded by any woman.
As always, parents need to educate themselves about risks and benefits and honestly assess their individual lifestyles and family histories. One would expect the parent of a child with any family or personal history of autoimmune disease to be particularly cautious. On the other hand, an individual or the parent of a child with a lifestyle known to strongly increase incidence of persistent HPV infection—a poor diet including few fruits and vegetables, a smoking habit, many sexual partners, frequent sleep deprivation, lousy hygiene habits—might be more enthusiastic about the vaccine and less concerned about possible side effects. Males should also know that not being circumcised also substantially raises the risk of both transient and persistent HPV infections. Even a transient infection (some 95 percent of HPV infections are simply shrugged off, virtually always leaving behind natural immunity to that particular strain) can cause a persistent infection in a partner.
We are, hopefully, long past the days when we assume that what’s good for one person (or many) is good for every individual. In the case of Gardasil, none of the available choices are risk-free.
So what do you think? Will you as parents be getting Gardasil for your sons, and will men be getting it for themselves?
Showing posts with label Gardasil for males. Show all posts
Showing posts with label Gardasil for males. Show all posts
Thursday, September 10, 2009
Tuesday, September 8, 2009
Gardasil for Men and Boys: What the FDA Committee Will Discuss on September 9
A lot of people who read this site have already sent in comments about Gardasil for review by the VRBPAC (the FDA’s Vaccine and Related Biological Products Advisory Committee). Committee members will consider these when they meet on Wednesday to discuss approval of Gardasil for men and boys, along with approval of Cervarix, GlaxoSmithKline’s competing HPV vaccine, and a few readers have even applied to make an oral presentation during the brief public comment periods.
But what else will the committee be looking at?
Gardasil for preventing genital warts, not cancer, in men
Turns out that the focus will be on Gardasil for preventing genital warts, not cancer, in men. That’s because Gardasil is indeed pretty effective (67 to 89.4 percent) for preventing HPV-caused genital warts, which are estimated to affect roughly one percent of the population.
However, penile and anal cancers, which can also be caused by HPV, are very rare. Because the progression of lesions to cancer is not as clearly defined in penile/anal/perineal cancers as it is in cervical cancer, and because a “substantial percentage of penile cancers are known to arise in the absence of detectable HPV,” Merck agreed to change its original request. Instead of asking to have Gardasil approved for preventing “external genital lesions,” it asked to have Gardasil considered solely as a genital wart preventative. Although Merck did study a subset of, as they put it, MSMs (Men having Sex with Men) in an attempt to assess Gardasil’s effect on anal cancer rates, they chose not to submit the data at this point.
Merck has been heavily criticized, most recently in JAMA, for over-selling Gardasil as a cervical cancer preventative. As Drs. Sheila and David Rothman wrote in JAMA, “No data were available to establish the duration of efficacy, possible adverse effects on natural immunity, whether vaccinated women will forgo Papanicolaou tests, and whether after suppressing HPV-16 and HPV-18, other strains may emerge as significant oncogenic serotypes.” Merck is apparently not going to try to pull that one off this time around, or at least,not yet.
Merck submitted data on a randomized, placebo-controlled study of 4065 males aged 16-26.
The data showed the expected efficacy for genital wart prevention and a number of other things, too, one of which was that in the placebo group rates of infection rose substantially in non-circumcised men and in those who had multiple partners (something to think about, guys).
And “a marked reduction in efficacy was seen in the setting of pre-existing infection.” In other words, you may not want to bother getting it if you’ve already become sexually active—or else you may want to get an HPV test before shelling out about $360 plus the cost of administration.
Adverse Events
As to adverse events (AEs), the background information that the VRBAC will consider didn’t show anything insanely significant. 69.2 percent of the Gardasil group versus 64.2 percent of the aluminum placebo group reported AEs, with notably more reporting injection site issues. Injection site AEs were far less frequent in the very small saline placebo group than in the much larger aluminum placebo group. 24.2 percent (Gardasil) versus 22.8 percent (placebo) reported new medical conditions.
Merck has been widely criticized for using an aluminum adjuvant in the placebo group, as such a practice can mask adverse reactions. Aluminum is somewhat suspect as a potential trigger for autoimmune and neurological disorders.
As with female populations, Gardasil appears to pose a somewhat higher risk of arthritis. 30, or 1 percent, of the Gardasil group developed arthralgia, arthritis, or reactive arthritis as opposed to 17, or 0.7 percent of the placebo group. There were also 3 (0.1 percent) versus 0 cases of hypothyroidism.
However, when all was said and done, the same percentage—1.4 percent—of both groups developed autoimmune disorders in the short term. There were no reports of the autoimmune diseases that have anecdotally been reported as occurring post-Gardasil in women and girls, such as the ALS-like “neurological disease mediated by immune responses” that, according to the autopsy, led to extensive damage in Jenny Tetlock’s spinal cord, and eventually to her death at 15. Gardasil has also been associated with Graves Disease, epilepsy, lupus, and various other immune disorders as well as multiple deaths. The FDA has not found that these conditions occurred significantly more frequently than in the overall population, although it recently warned that it was certainly associated with a higher number of blood clots as well as syncope.
The placebo group consisted of 2033 males injected with the aluminum adjuvant and just 322 injected with saline. Perhaps one day the FDA will demand a real placebo-controlled study of the adverse effects of vaccination, using saline only as a placebo.
A lot of the discussion about Gardasil for men and boys has focused on giving it to young boys as a way of preventing HPV in their future partners. That’s an unusual departure for a vaccination, although it still contributes to one of the goals of vaccination—“herd immunity.” The VRBPAC, however, will not consider this issue. Nor will it consider the potential for educating people about how not smoking, getting circumcised, eating lots of fruits and vegetables, delaying sexual activity, using condoms (about 70 percent effective) and limiting sexual partners, can all help people to dramatically reduce rates of persistent HPV infections. That might be a reasonable alternative for many people, rather than burdening growing bodies with yet another vaccine.
Instead, the VRBPAC will look solely at whether “the overall risk/benefit ratio” is favorable for approval of Gardasil as a means of preventing genital warts in men, and whether the post-marketing plan is adequate for assessing safety. That’s it.
My guess is that Gardasil will be approved for men and boys, and will join the ever-increasing number of vaccinations recommended for all children. Every parent and every young adult will have to sort through the pros and cons for themselves. Don't forget to honestly considering your lifestyle and your family history of autoimmune disease while making that decision.
But what else will the committee be looking at?
Gardasil for preventing genital warts, not cancer, in men
Turns out that the focus will be on Gardasil for preventing genital warts, not cancer, in men. That’s because Gardasil is indeed pretty effective (67 to 89.4 percent) for preventing HPV-caused genital warts, which are estimated to affect roughly one percent of the population.
However, penile and anal cancers, which can also be caused by HPV, are very rare. Because the progression of lesions to cancer is not as clearly defined in penile/anal/perineal cancers as it is in cervical cancer, and because a “substantial percentage of penile cancers are known to arise in the absence of detectable HPV,” Merck agreed to change its original request. Instead of asking to have Gardasil approved for preventing “external genital lesions,” it asked to have Gardasil considered solely as a genital wart preventative. Although Merck did study a subset of, as they put it, MSMs (Men having Sex with Men) in an attempt to assess Gardasil’s effect on anal cancer rates, they chose not to submit the data at this point.
Merck has been heavily criticized, most recently in JAMA, for over-selling Gardasil as a cervical cancer preventative. As Drs. Sheila and David Rothman wrote in JAMA, “No data were available to establish the duration of efficacy, possible adverse effects on natural immunity, whether vaccinated women will forgo Papanicolaou tests, and whether after suppressing HPV-16 and HPV-18, other strains may emerge as significant oncogenic serotypes.” Merck is apparently not going to try to pull that one off this time around, or at least,not yet.
Merck submitted data on a randomized, placebo-controlled study of 4065 males aged 16-26.
The data showed the expected efficacy for genital wart prevention and a number of other things, too, one of which was that in the placebo group rates of infection rose substantially in non-circumcised men and in those who had multiple partners (something to think about, guys).
And “a marked reduction in efficacy was seen in the setting of pre-existing infection.” In other words, you may not want to bother getting it if you’ve already become sexually active—or else you may want to get an HPV test before shelling out about $360 plus the cost of administration.
Adverse Events
As to adverse events (AEs), the background information that the VRBAC will consider didn’t show anything insanely significant. 69.2 percent of the Gardasil group versus 64.2 percent of the aluminum placebo group reported AEs, with notably more reporting injection site issues. Injection site AEs were far less frequent in the very small saline placebo group than in the much larger aluminum placebo group. 24.2 percent (Gardasil) versus 22.8 percent (placebo) reported new medical conditions.
Merck has been widely criticized for using an aluminum adjuvant in the placebo group, as such a practice can mask adverse reactions. Aluminum is somewhat suspect as a potential trigger for autoimmune and neurological disorders.
As with female populations, Gardasil appears to pose a somewhat higher risk of arthritis. 30, or 1 percent, of the Gardasil group developed arthralgia, arthritis, or reactive arthritis as opposed to 17, or 0.7 percent of the placebo group. There were also 3 (0.1 percent) versus 0 cases of hypothyroidism.
However, when all was said and done, the same percentage—1.4 percent—of both groups developed autoimmune disorders in the short term. There were no reports of the autoimmune diseases that have anecdotally been reported as occurring post-Gardasil in women and girls, such as the ALS-like “neurological disease mediated by immune responses” that, according to the autopsy, led to extensive damage in Jenny Tetlock’s spinal cord, and eventually to her death at 15. Gardasil has also been associated with Graves Disease, epilepsy, lupus, and various other immune disorders as well as multiple deaths. The FDA has not found that these conditions occurred significantly more frequently than in the overall population, although it recently warned that it was certainly associated with a higher number of blood clots as well as syncope.
The placebo group consisted of 2033 males injected with the aluminum adjuvant and just 322 injected with saline. Perhaps one day the FDA will demand a real placebo-controlled study of the adverse effects of vaccination, using saline only as a placebo.
A lot of the discussion about Gardasil for men and boys has focused on giving it to young boys as a way of preventing HPV in their future partners. That’s an unusual departure for a vaccination, although it still contributes to one of the goals of vaccination—“herd immunity.” The VRBPAC, however, will not consider this issue. Nor will it consider the potential for educating people about how not smoking, getting circumcised, eating lots of fruits and vegetables, delaying sexual activity, using condoms (about 70 percent effective) and limiting sexual partners, can all help people to dramatically reduce rates of persistent HPV infections. That might be a reasonable alternative for many people, rather than burdening growing bodies with yet another vaccine.
Instead, the VRBPAC will look solely at whether “the overall risk/benefit ratio” is favorable for approval of Gardasil as a means of preventing genital warts in men, and whether the post-marketing plan is adequate for assessing safety. That’s it.
My guess is that Gardasil will be approved for men and boys, and will join the ever-increasing number of vaccinations recommended for all children. Every parent and every young adult will have to sort through the pros and cons for themselves. Don't forget to honestly considering your lifestyle and your family history of autoimmune disease while making that decision.
Tuesday, August 18, 2009
Tell the FDA Your Opinion of Gardasil
No doubt the FDA catches some of the rumblings, questions and side-effect horror stories about Merck’s Gardasil that constantly percolate through the internet and media. But now you’ll have a chance to address the agency directly, when the Vaccines and Related Biological Products Advisory Committee meets to discuss the HPV vaccine.
The Committee will meet on September 9, 2009 in Maryland. On the agenda: a discussion about the effectiveness and safety of GlaxoSmithKline’s Cervarix vaccine against the HPV virus for females, and another about the advisability of recommending the Gardasil vaccine for males.
And here’s where you (maybe) come in: the public is invited to make a written or oral presentation of data, information, or a viewpoint about either issue. Background material will hopefully be available online two business days ahead of the meeting; otherwise it will be available after the meeting. Unfortunately only two half-hour public comment sessions are scheduled, so good luck getting in there, but here are the rules anyway.
"Written submissions may be made to the contact person on or before September 4, 2009
Oral presentations from the public will be scheduled between approximately 11:30 a.m. and 12:00 p.m. and 3:40 p.m. and 4:10 p.m.
Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before August 27, 2009. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by September 3, 2009.
Contact Information
Christine Walsh, R.N.1401 Rockville Pike, HFM-71, Rockville, MD 20852301-827-0314FAX: 301-827-0294e-mail: Christine.Walsh@fda.hhs.gov
FDA Advisory Committee Information Line1-800-741-8138 (301-443-0572 in the Washington, DC, area)code 3014512391. Please call the Information Line for up-to-date information on this meeting. "
The Committee will meet on September 9, 2009 in Maryland. On the agenda: a discussion about the effectiveness and safety of GlaxoSmithKline’s Cervarix vaccine against the HPV virus for females, and another about the advisability of recommending the Gardasil vaccine for males.
And here’s where you (maybe) come in: the public is invited to make a written or oral presentation of data, information, or a viewpoint about either issue. Background material will hopefully be available online two business days ahead of the meeting; otherwise it will be available after the meeting. Unfortunately only two half-hour public comment sessions are scheduled, so good luck getting in there, but here are the rules anyway.
"Written submissions may be made to the contact person on or before September 4, 2009
Oral presentations from the public will be scheduled between approximately 11:30 a.m. and 12:00 p.m. and 3:40 p.m. and 4:10 p.m.
Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before August 27, 2009. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by September 3, 2009.
Contact Information
Christine Walsh, R.N.1401 Rockville Pike, HFM-71, Rockville, MD 20852301-827-0314FAX: 301-827-0294e-mail: Christine.Walsh@fda.hhs.gov
FDA Advisory Committee Information Line1-800-741-8138 (301-443-0572 in the Washington, DC, area)code 3014512391. Please call the Information Line for up-to-date information on this meeting. "
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