Hey Professors, Pay Up

As you might know, Michele Bachmann claimed that a woman came up to her, crying, saying that her child suffered mental retardation after being vaccinated for HPV.  A couple of professors question her claim.  The story is reported by Chris Moody.

Minnesota Rep. Michele Bachmann's story about a woman who claimed that her daughter suffered 'mental retardation' after receiving a vaccine against HPV could fetch the woman's family thousands of dollars. But the family can only collect if Bachmann or the unnamed woman can prove the story is true.

Two bioethics professors have offered to pay more than $10,000 for medical records that prove the anecdote Bachmann told after Monday night's Republican presidential debate is true[.]

I'd like to collect that $10,000 now, professors.

I ask the professors to look up a case in the CDC's VAERS database.  Specifically, VAERS number 380440.  The case was reported in Oregon on February 15, 2010.  The patient was 12 years old.  The symptoms in that case were reported in the VAERS database as follows.  (My emphases.)

Since receiving 1st dose of Gardasil, I started noticing a decline in my child's mental health.  She has become depressed and has extreme difficulty concentrating.  Shortly after receiving her 3rd dose of the vaccine, she started having stomach pains.  These have continued to this date.  We have had an ultrasound, CT scan, blood and urine work done, still no answers.

The professors might also look up VAERS case number 396852.  That case was reported in New York on August 8, 2010.  The patient was 20 years old.

Was called by outside institution. Pt is admitted for acute mental status change. Physician caring for Pt states she is very disorganized in her thinking. Pt prior was normal functioning. Pt is still hospitilized in psychiatric hospital x 5 days.

The professors might also look up VAERS case number 339718.  That case was reported in Indiana on February 17, 2009.  The patient was 13 years old.

Approx 3 weeks after getting 1st set of Gardasil, patient complained that she was weak and was having a hard time speaking. On 11/29/08 patient had 2 seizures. She was was taken to the ER. Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She is on a ventilator & has a feeding tube. She has neurological movements. All of the testing done shows that patient has encephalitis. The cause of the Encephalitis is a reaction to the Gardasil Vaccine... FINAL DX: meningoencephalitis w/significant mental changes & seizures Records reveal patient experienced seizure that progressed to loss of speech, sustained focal seizures... seizure disorder; history of depression w/suicidal attempts... not able to follow commands... severe neurological damage.  Now w/fever, hypotension & decreased mental status[.]

Do I get my $10,000 yet?

Then there is case 337242 from 2009, although it doesn't mention mental health.

My daughter had her 3rd GARDASIL vaccine in Sept. She was a very healthy young lady, she went to take a shower and died. Autopsy report states undermined death. There was no sign of trauma to the body to indicate a fall. She had pointed the shower head away from her and she got down on her knees and put her head on the edge of the tub and passed away. This has been a living nightmare for her family. She is not the only one to have had problems and death from this vaccine. Please I beg you to please take it off until it can be further tested. -not tested long enough to begin with- There will be others that will die if the cause is not found.

Of course, just because symptoms followed the vaccinations does not mean the vaccinations caused the symptoms.  (Although in case 339718, the remarks do indicate that the vaccine was the cause of the encephalitis that led to the symptoms.)  The CDC summarized the adverse effects following vaccinations with Gardasil®.

As of June 22, 2011, approximately 35 million doses of Gardasil® were distributed in the U.S. and VAERS received a total of 18,727 reports of adverse events following Gardasil® vaccination... Of the total number of VAERS reports following Gardasil®, 92% were considered to be non-serious, and 8% were considered serious*...

As of June 22, 2011 there have been a total 68 VAERS reports of death among those who have received Gardasil® .

*"Serious" means "hospitalization, permanent disability, life-threatening illness, congenital anomaly or death."

My arithmetic says there were about 1,500 serious adverse events out of 35 million doses, for a rate of about 4 per 100,000 doses.  Since each patient gets about three doses, that is 12 serious adverse events per 100,000 vaccinated patients.

On the other hand, about two white women in 100,000 die each year from cervical cancer.  (For black women, the rate is about four per 100,000.)  HPV vaccines are considered "highly effective" in preventing infections of "two high-risk HPVs that cause about 70 percent" of cervical cancers.

I don't know about you, but that tradeoff does not appear obvious to me.  I'm glad so many fact-based pundits find these numbers easier to fathom.

Here are some credentialed people who were able to fathom such numbers at the time: Gail Javitt, Deena Berkowitz, and Lawrence O. Gostin.  In 2008 they wrote in the Journal of Law, Medicine & Ethics.  They concluded as follows.

In light of these potentially adverse public health, economic, and societal consequences, we believe that it is premature for states to add HPV to the list of state-mandated vaccines ... mandating HPV vaccination at the present time would be premature and ill-advised.

The "present time" was the summer of 2008.  Gov. Rick Perry wrote his executive order mandating the vaccine in February 2007.

In May 2007, after Governor Perry wrote his executive order, George F. Sawaya and Karen Smith-McCune, both medical doctors, wrote as follows in the New England Journal of Medicine.

What can be inferred from these data about the potential effect of vaccination among girls 11 and 12 years of age? The FUTURE trials did not enroll subjects in this age group ... a cautious approach may be warranted in light of important unanswered questions about overall vaccine effectiveness, duration of protection, and adverse effects that may emerge over time.

Perry's February 2007 order was to make the vaccine mandatory for girls of age 12.

Just a reminder: I am not a doctor and I do not play one on the internet.  But the concern of the bioethics professors was not whether HPV vaccines cause "mental retardation," but whether a real woman came up to Michele Bachmann and said such a thing.  They were accusing Bachmann of lying about the incident, not about the safety of Gardasil® .

Given my very brief scan of the VAERS database, and only for 2009-10, I find it very believable that some mother out there believes her daughter suffered mental retardation after receiving the HPV vaccine.  Especially if that mother is from Indiana and her daughter is about 15 years old now.

Randall Hoven can be followed on Twitter.  His bio and previous writings can be found at randallhoven.com.

As you might know, Michele Bachmann claimed that a woman came up to her, crying, saying that her child suffered mental retardation after being vaccinated for HPV.  A couple of professors question her claim.  The story is reported by Chris Moody.

Minnesota Rep. Michele Bachmann's story about a woman who claimed that her daughter suffered 'mental retardation' after receiving a vaccine against HPV could fetch the woman's family thousands of dollars. But the family can only collect if Bachmann or the unnamed woman can prove the story is true.

Two bioethics professors have offered to pay more than $10,000 for medical records that prove the anecdote Bachmann told after Monday night's Republican presidential debate is true[.]

I'd like to collect that $10,000 now, professors.

I ask the professors to look up a case in the CDC's VAERS database.  Specifically, VAERS number 380440.  The case was reported in Oregon on February 15, 2010.  The patient was 12 years old.  The symptoms in that case were reported in the VAERS database as follows.  (My emphases.)

Since receiving 1st dose of Gardasil, I started noticing a decline in my child's mental health.  She has become depressed and has extreme difficulty concentrating.  Shortly after receiving her 3rd dose of the vaccine, she started having stomach pains.  These have continued to this date.  We have had an ultrasound, CT scan, blood and urine work done, still no answers.

The professors might also look up VAERS case number 396852.  That case was reported in New York on August 8, 2010.  The patient was 20 years old.

Was called by outside institution. Pt is admitted for acute mental status change. Physician caring for Pt states she is very disorganized in her thinking. Pt prior was normal functioning. Pt is still hospitilized in psychiatric hospital x 5 days.

The professors might also look up VAERS case number 339718.  That case was reported in Indiana on February 17, 2009.  The patient was 13 years old.

Approx 3 weeks after getting 1st set of Gardasil, patient complained that she was weak and was having a hard time speaking. On 11/29/08 patient had 2 seizures. She was was taken to the ER. Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She is on a ventilator & has a feeding tube. She has neurological movements. All of the testing done shows that patient has encephalitis. The cause of the Encephalitis is a reaction to the Gardasil Vaccine... FINAL DX: meningoencephalitis w/significant mental changes & seizures Records reveal patient experienced seizure that progressed to loss of speech, sustained focal seizures... seizure disorder; history of depression w/suicidal attempts... not able to follow commands... severe neurological damage.  Now w/fever, hypotension & decreased mental status[.]

Do I get my $10,000 yet?

Then there is case 337242 from 2009, although it doesn't mention mental health.

My daughter had her 3rd GARDASIL vaccine in Sept. She was a very healthy young lady, she went to take a shower and died. Autopsy report states undermined death. There was no sign of trauma to the body to indicate a fall. She had pointed the shower head away from her and she got down on her knees and put her head on the edge of the tub and passed away. This has been a living nightmare for her family. She is not the only one to have had problems and death from this vaccine. Please I beg you to please take it off until it can be further tested. -not tested long enough to begin with- There will be others that will die if the cause is not found.

Of course, just because symptoms followed the vaccinations does not mean the vaccinations caused the symptoms.  (Although in case 339718, the remarks do indicate that the vaccine was the cause of the encephalitis that led to the symptoms.)  The CDC summarized the adverse effects following vaccinations with Gardasil®.

As of June 22, 2011, approximately 35 million doses of Gardasil® were distributed in the U.S. and VAERS received a total of 18,727 reports of adverse events following Gardasil® vaccination... Of the total number of VAERS reports following Gardasil®, 92% were considered to be non-serious, and 8% were considered serious*...

As of June 22, 2011 there have been a total 68 VAERS reports of death among those who have received Gardasil® .

*"Serious" means "hospitalization, permanent disability, life-threatening illness, congenital anomaly or death."

My arithmetic says there were about 1,500 serious adverse events out of 35 million doses, for a rate of about 4 per 100,000 doses.  Since each patient gets about three doses, that is 12 serious adverse events per 100,000 vaccinated patients.

On the other hand, about two white women in 100,000 die each year from cervical cancer.  (For black women, the rate is about four per 100,000.)  HPV vaccines are considered "highly effective" in preventing infections of "two high-risk HPVs that cause about 70 percent" of cervical cancers.

I don't know about you, but that tradeoff does not appear obvious to me.  I'm glad so many fact-based pundits find these numbers easier to fathom.

Here are some credentialed people who were able to fathom such numbers at the time: Gail Javitt, Deena Berkowitz, and Lawrence O. Gostin.  In 2008 they wrote in the Journal of Law, Medicine & Ethics.  They concluded as follows.

In light of these potentially adverse public health, economic, and societal consequences, we believe that it is premature for states to add HPV to the list of state-mandated vaccines ... mandating HPV vaccination at the present time would be premature and ill-advised.

The "present time" was the summer of 2008.  Gov. Rick Perry wrote his executive order mandating the vaccine in February 2007.

In May 2007, after Governor Perry wrote his executive order, George F. Sawaya and Karen Smith-McCune, both medical doctors, wrote as follows in the New England Journal of Medicine.

What can be inferred from these data about the potential effect of vaccination among girls 11 and 12 years of age? The FUTURE trials did not enroll subjects in this age group ... a cautious approach may be warranted in light of important unanswered questions about overall vaccine effectiveness, duration of protection, and adverse effects that may emerge over time.

Perry's February 2007 order was to make the vaccine mandatory for girls of age 12.

Just a reminder: I am not a doctor and I do not play one on the internet.  But the concern of the bioethics professors was not whether HPV vaccines cause "mental retardation," but whether a real woman came up to Michele Bachmann and said such a thing.  They were accusing Bachmann of lying about the incident, not about the safety of Gardasil® .

Given my very brief scan of the VAERS database, and only for 2009-10, I find it very believable that some mother out there believes her daughter suffered mental retardation after receiving the HPV vaccine.  Especially if that mother is from Indiana and her daughter is about 15 years old now.

Randall Hoven can be followed on Twitter.  His bio and previous writings can be found at randallhoven.com.

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