Tag Archives: Centers for Disease Control and Prevention

Insurance Companies Make It Difficult For Pediatricians

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The human papilloma virus (HPV) vaccine (Gardasil, Cervarix) has been approved for use in girls for several years now, allowing us to protect our young female patients from many cases of cervical cancer and genital warts. While the benefits likely will not be seen for some time, as pediatricians we are excited to be able to provide, for the first time, definitive protection against a virus-caused type of cancer.

Approval for use of the vaccine against HPV in boys has been slower in coming, however. While they do not get cervical cancer, for obvious reasons, males are susceptible to other forms of disease caused by HPV, including genital warts, and they can also serve as a vector for transmission of this virus to their sexual partners, so including them in the target group for protection makes good scientific sense.

Recently, however, the American Academy of Pediatrics came out with a recommendation to use the vaccine (Gardasil) in males as well as females. This was followed by a similar recommendation by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC). Having received this “official” approval, many of us have begun immunizing our adolescent male patients, and the acceptance of the vaccine by these patients and their parents has been encouraging. Initially, payment for the vaccine was an issue, but the vaccine has been approved for use by the Vaccines for Children (VFC) program, and most health insurance carriers are covering the vaccine for their insureds as well.

Most, but not all, however.

Our group, along with a number of others, has been told by the large national insurance company United HealthCare that the HPV vaccine is NOT a covered benefit for adolescent males. While other national insurance companies have been paying for the vaccine for months now, UHC was first waiting for the CDC to recommend it. Now that that has occurred, they state that they are waiting for that recommendation to be published in MMWR, the weekly report of the CDC, which can take time to occur, And after that, they claim that, by their contracts, they have an ADDITIONAL 60 days to begin to pay for it.

So despite the fact that this vaccine has been recommended and recognized as important for good health by many organizations and governmental bodies, United HealthCare is using SEMANTICS to delay covering a medical procedure which has been shown to be effective in preventing disease in patients who are paying premiums to United for just that sort of health assurance.

Frankly, in my opinion, this is a disgrace. The only reason for refusing to cover this vaccine upon CDC recommendation can be that United HealthCare does not want to cover the expense of this admittedly costly vaccine.

As physicians, we recommend that all adolescents, male and female, be vaccinated against HPV. And as parents, we want to do all that we can to protect our children, of both genders, from a preventable disease. If United HealthCare is your insurer, call them and object to their short-sighted and greedy policy. There is no reason that your children should be denied the protection paid for by virtually every other major health insurance company.

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HPV Vaccine Unsafe? Pediatricians Weighed In

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Written by Brandon Betancourt

Recently, a parent of one of our patients sent us a link regarding the Gardasil (HPV) vaccine and the claim that it doesn’t protect against cervical cancer.  The headline of the article the parent sent me is titled “Merck Researcher Admits: Gardasil Guards Against Almost Nothing.”

I had never heard of this claim before, so I asked a group of pediatricians what they made of this allegation and if they knew Dr. Diane Harper, the person quoted in the blog post. I also asked if they had any thoughts on the article itself; which was posted by the Population Research Institute, a non-profit organization tasked to debunk the myth of overpopulation.

I got quite bit of feedback that I’d like to share with you because I think it is important for objective individuals to dissect these claims and set the record straight.

By the way, if you would like to read the actual article by the non-profit that makes the claims, you can Google it. I really don’t want to send any traffic to the site. So I’m only going to quote on the pieces that the pediatricians commented on.

The first one to respond, was Dr. Zurhellen. He had an issue with this line from the article:

“…1 out of 912 who received Gardasil in the study died.”

Here is Dr. Zurhellen’s response to that:

If, really, 1 out of 912 girls vaccinated…died…from the vaccine…could this be hidden from us ?  Since over 38 million doses have been given, and that probably represents about fifteen million women/girls…that would translate as sixteen thousand (rough round-offs…) deaths.    Where was the media coverage of 16,000 vaccine deaths?  Nowhere since it did not happen.

Dr. Berman had a very practical analogy that actually makes a lot of sense:

This is kind of like saying seat belts don’t do a thing to prevent drunk driving, so what good are they?

Dr. Horowitz emphasized that in order to deconstruct Dr. Harper’s claims, one needs to understand how medical studies are done, understand the natural history of diseases or medical statistics.

For example, he quoted this from the article

70% of HPV infections resolve themselves without treatment in one year. After two years, this rate climbs to 90%. Of the remaining 10% of HPV infections, only half coincide with the development of cervical cancer.

And had this to say:

So let’s do the math: “only” 5% of cases of HPV infection are associated with cervical cancer. Given infection rates of about 50%, this amounts to 2.5% of the total female population at risk for cervical cancer. This is an enormous number of women.  In the millions…

Dr Horowitz had an issue with this statement as well:

“the death rate from cervical cancer continues to decline by nearly 4% each year.” Let’s do the math. If the 4% annual decline in cervical cancer death continues, in 60 years there will have been a 91.4% decline in cervical cancer death just from current cancer monitoring and treatment.

So let’s attribute this to better overall medical care in general, and earlier detection specifically. However, it is ludicrous to expect this diminution of death rates to continue forever. You may be able to squeeze 2 qts. of water out of a sponge, but it is silly to think that this is a linear relationship, with the amount of water per effort being the same with the 1st squeeze and the 10th.

“The rate of serious adverse events is greater than the incidence rate of cervical cancer.” 

Unfortunately, she shows her ignorance in not understanding what a serious adverse event is. I believe that every kid who fainted had a (serious?) adverse event.

Dr. Lessin added:

A serious adverse event is defined by the FDA as one that causes hospitalization or death.  Extremely few were reported.  The FDA also requires that every event that happens after a research intervention be reported.  This is why you see ear infections as a side effect of many medications.  Clearly there is no causal relationship other than the person got an ear infection around the time of the trial.

Others weighed in as well.

I tried to learn a bit more about Dr. Diane Harper and found numerous articles where she says was misquoted quite badly in other articles, some of which were picked up by the likes of CBS and MSNBC.

… there is some accuracy mixed in with what I would consider a careless disregard for fact. For example, of the 15,000 (now 19,000, depending on the article), adverse effects reported to the CDC, 94% were non-serious, such as swelling around the vaccine point or fainting after receiving the vaccine. Of the 6% that were serious, they have been closely monitored. Of the 23 deaths reported since the vaccine was introduced, none of the deaths were linked to the vaccine.

John Canning shared a Medscape article titled HPV Vaccine Deemed Safe and Effective, Despite Reports of Adverse Events (if you click on the link, Medscape will ask you to signup. But if you Google the title of the article, you can go directly to the article.)

The article is interesting and I encourage you to read it, but in essence, it concludes with this:

“Based on ongoing assessments of vaccine safety information, the FDA and CDC continue to find that Gardasil is a safe and effective vaccine,” the agencies said in a statement released on July 22, 2008. “The benefits continue to outweigh the risks,” they said. “This vaccine is an important cervical cancer prevention tool,” they added.

The takeaway is this

The HPV vaccine is highly effective in preventing four types of HPV in young women who have not been previously exposed to HPV. This vaccine targets HPV types that cause up to 70% of all cervical cancers and about 90% of genital warts.

Moreover, the vaccine has been licensed by the FDA as safe and effective. This vaccine has been tested in thousands of females (9 to 26 years of age) around the world. These studies have shown no serious side effects.

Dr. Harper was very likely misquoted.  If not, then she clearly does not understand statistics or causation and draws conclusions based on her opinion, rather than the facts.

To read more, visit the CDC’s website or click on this link.

Brandon is a practice administrator. He blogs regularly on practice management issues at PediatricInc.com. He and his wife (a pediatrician) are pro-vaccine and have vaccinated their  3 children with all the age appropriate vaccines. 

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Actually, The Vast Majority of Children Do Get Their Vaccines On Time

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Written by Brandon Betancourt

Dr. Ari Brown over at the Baby411 blog had a very interesting post where she looked in to a study, published in a pediatric journal, regarding parent’s attitude towards the vaccination schedule recommended by the American Academy of Pediatrics, The American Academy of Family Physicians and the Centers for Disease Control.

The study concluded that more than 1 of 10 parents of young children currently use an alternative vaccination schedule. In addition, a large proportion of parents currently following the recommended schedule seem to be “at risk” for switching to an alternative schedule.

Dr. Brown had a similar reaction to mine. She thought that the statistics were too high considering that a “vast majority of the families she treats DO follow the recommended schedule.”

In our practice, we too have a very small portion of parents that choose to “alter” the recommended schedule. Certainly well below the 10% mark.

But  Dr. Brown didn’t just settled.  She did what any good pediatrician does, which is, take a look a the data to understand where the numbers are coming from and how the researchers reached their conclusions.

Her findings provide a lot of insight.

She first mentions that the study was done in May of 2010, but it was just now published.

A lot has happened since May 2010 in the vaccine world (besides Michele Bachmann). In the same month that this survey was being done, the British researcher who published the now-retracted 1998 MMR-autism study in the Lancet lost his medical license for questionable practices. With this story, national media sided with modern medicine instead of conspiracy theorists on vaccine safety. That trend has been fairly consistent since then, and I think, has led to fewer parental concerns.

Dr. Brown highlights that the response rate from the study was only 61%; which could very well represent skewed data.

People who choose to vaccinate may have no interest in spending time answering questions about vaccine safety. People who choose to delay or skip vaccinations may want to share their position. It is hard to know what motivates people to participate in a survey, but it may influence the study results.

The first vaccine that parents refused or delayed was the H1N1 and the second, the seasonal flu.

Although there was outright hysteria regarding the H1N1 outbreak and calls for a rapidly available vaccine to combat it, there was also quite a bit of public anxiety about taking a vaccine that had not been field tested prior to use.

I agree with Dr. Brown when she points out that the seasonal flu should not be placed under the same category as other vaccines because with exception of New Jersey, the  flu vaccine is not required for school entry.

While the CDC and AAP recommend annual flu vaccine, it is never included in the national immunization survey done annually by the CDC she adds.

I love Dr. Brown’s conclusions:

The most effective message I can share with you and my own patients is that I vaccinate my own children to protect them, I wouldn’t do anything differently for yours.

Here lies the problem. This study was picked up by many mainstream media outlets including CNN running with headlines like “More parents think it’s safer to delay vaccines,” “Parents Commonly Deviate from Vaccine Schedule,” and “Many parents opt for “alternative” vaccination schedule.”

But the truth of the matter is, the vast majority of parents in the study vaccinate their children on time.

You may read Dr. Brown’s entire article by clicking here

Brandon is a practice administrator, speaker and blogger. He and his wife, whom is a pediatrician, vaccinate their three children. 

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Michele Bachmann Is Not a Doctor (she reveals), But Pediatricians Are

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Written by Brandon Betancourt

Last night was the GOP debate. We saw the usual stuff that is expected in these things. The candidates debated Social Security, jobs and the economy. During the debate, however, Michele Bachmann, member of the United States House of Representatives, said that vaccines, particularly the HPV vaccine, caused “mental retardation.”

Bachmann, in a post-debate interview, told Fox News that a woman had approached her and told her that she had a daughter who “suffered mental retardation as a result of the vaccine.”

Bachmann shared the same story on the Today show, telling Matt Lauer that the woman’s “little daughter took that vaccine, that injection, and she suffered from mental retardation thereafter.”

In an interview with Sean Hannity she had this to say when asked about her claims

“I have no idea … I am not a doctor, I’m not a scientist, I’m not a physician. All I was doing is reporting what this woman told me last night at the debate …”

I find it irresponsible that a congressional representative, or anybody with that kind of influence, would make such a claim on a national stage going only on the anecdote of a stranger.

I hope that parents listening to this type of rhetoric understand that politicians are politicians, who may or may not have people’s best interests at heart.

Michele Bachmann is obviously not educated enough in the science behind vaccines. But here is what I hope parents understand. Your pediatrician does have your children’s  best interest at heart. That is why pediatricians recommend that girls receive HPV vaccine around age 11 or 12.

The American Academy of Pediatrics issued an important press release rebutting Bachmann’s HPV claim. Here is the official response from the American Academy of Pediatrics:

“The American Academy of Pediatrics would like to correct false statements made in the Republican presidential campaign that HPV vaccine is dangerous and can cause mental retardation. There is absolutely no scientific validity to this statement. Since the vaccine has been introduced, more than 35 million doses have been administered, and it has an excellent safety record.

“The American Academy of Pediatrics, the Centers for Disease Control and Prevention, and the American Academy of Family Physicians all recommend that girls receive HPV vaccine around age 11 or 12. That’s because this is the age at which the vaccine produces the best immune response in the body, and because it’s important to protect girls well before the onset of sexual activity. In the U.S., about 6 million people, including teens, become infected with HPV each year, and 4,000 women die from cervical cancer. This is a life-saving vaccine that can protect girls from cervical cancer.”

For other related stories, click on the links below.

Vaccination Causes ‘Mental Retardation’? Fact-Checking Michele Bachmann’s Claim

GOP’s Bachmann claims shot to prevent cervical cancer can cause mental retardation. That is simply a lie

Pediatricians Fact-Check Bachmann’s Bashing of HPV Vaccine

 

Brandon is a practice administrator for Salud Pediatrics and blog at PediatricInc

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Brain-eating amoebas, internet info, and risk (oh my!)

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Written by David Sullo MD

It was with great sadness that I read of the third case of Naegleria fowleri infection (the “brain-eating amoeba) this summer.  Death in children is always tragic, but especially so when it is so unexpected and brought on by something so innocent as hitting the local swimming hole.

As a physician, I expected parents to be asking about it in the coming days and weeks, so decided to educate myself.  I thought I would write how I went about it, and how I think about it, as there are some good things to be learned about how to find medical info AND interpret it.

My first stop was to Wikipedia for some general info on the bug itself:

http://en.wikipedia.org/wiki/Naegleria_fowleri

Interestingly, it isn’t actually an amoeba as billed in the press, but that’s a tangent.  That then led me to the CDC website, which had more specific information on the actual rate of infections, possible treatments, and prevention strategies:

http://www.cdc.gov/parasites/naegleria/faqs.html

So in the end, there’s a couple of things to say:

a) Get your info from reputable sites.  Note I did not use a site that says “BRAIN eating AMOEBAS can KILL YOU!  Buy our nose spray and you’ll be protected!  Our nose spray is scientifically proven to block all amoebas!”

b) Some things are just tragic.  The CDC site makes an important point, which is that over 10 years there’s been 32 cases of this disease, but millions of people have gone swimming in these same places and NOT gotten this disease.  We’ll probably never know why these very few kids get the disease and the vast majority do not.

c) Modern medicine doesn’t have all the answers, yet.  This disease is almost uniformly fatal because it often is not recognized as Naegleria until late in the illness (or even post-mortem), and there is not a good treatment even when it is diagnosed early.  If we can develop better methods of detection and better treatments, the prognosis for these kids may improve.

d) Educate yourself.  The vast majority of cases are in southern states, in fresh water, and usually in warmer water (hot springs, etc).  There’s been only one case in a northern state (Minnesota).  So if you are going to the beach for a week on the Jersey shore, you can relax.

e) Take reasonable precautions.  You can 100% avoid this by never swimming again, but that’s not what I would call reasonable.  The CDC suggests this:

  • Avoid water-related activities in warm freshwater during periods of high water temperature and low water levels.
  • Hold the nose shut or use nose clips when taking part in water-related activities in bodies of warm freshwater.
  • Avoid digging in, or stirring up, the sediment while taking part in water-related activities in shallow, warm freshwater areas.

f) Remember what’s important.  Remember the 32 cases in 10 years noted above?  In a typical 10 year span, there are 36,000 drownings in the US.  Drownings don’t make national headlines like brain-eating amoeba do, but your child is literally 1000 times more likely to drown than to catch Naegleria.  So don’t lose sleep over the brain-eating amoeba but then take your child on a boat without a life jacket.

I hope this glimpse into the brain of a pediatrician was helpful.  I would also like to extend our sincerest condolences to the families of these children; we can only hope that  the increased public awareness from these cases leads to work on an effective treatment.

Dr. Sullo is a pediatrician at Genesis Pediatrics in Rochester, New York. He admits to having gone to computer camp in 5th grade when everyone else was playing baseball, and is an “Apple Fanboy.” He does his best to offset the geekiness by throwing in some winter backpacking.