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Vaccine under suspicion

Stow family thinks series of shots meant to protect women from cervical cancer actually to blame for teen girl's illness

Federal health officials, Merck insist Gardasil continues to be safe

By Cheryl Powell
Beacon Journal medical writer

Published on Monday, Mar 09, 2009

For months, more than a dozen doctors have studied why Kenzie Bear has been so sick.

The once-healthy, active 15-year-old from Stow suffers from constant nausea, debilitating fatigue, seizures and other symptoms that have left her unable to attend school or play sports.

''Sometimes I'm afraid to go to sleep,'' Kenzie said, ''because I'm afraid I won't wake up.''

Now her mother, Jenna, is among a small, but growing community of parents nationwide who are concerned a series of shots meant to protect their daughters from cervical cancer instead might have made the girls incredibly ill.

They're sharing their suspicions about the vaccination called Gardasil in online blogs and chat rooms, as well as in national news stories covering the controversy.

''This is a horrible thing on a mom who signs a paper and says it's OK to give a vaccine,'' Kenzie's mother said. '' . . . They need to stop until they study it more, that's for sure.''

But federal health officials and Merck & Co. Inc., the maker of Gardasil, insist the vaccine continues to be a safe, effective series of inoculations against the sexually transmitted human papillomavirus, known as HPV.

Gardasil protects against strains of the virus believed to be responsible for about 70 percent of cases of cervical cancer, a disease that kills almost 4,000 American women annually.


When the U.S. Food and Drug Administration first approved the three-shot series in 2006 for girls and women ages 9 to 26, medical experts heralded the breakthrough as the first vaccine to prevent a known cause of cancer.

Some critics raised ethical concerns about giving adolescents shots designed to protect against a sexually transmitted disease.

But on its Web site, the FDA indicates that Gardasil ''is an important cervical cancer prevention tool that will potentially benefit the health of millions of women.''

According to the U.S. Centers for Disease Control and Prevention, more than 23 million doses of Gardasil had been distributed nationwide as of Dec. 31.

As of that date, 11,916 reports of adverse reactions following Gardasil vaccination were made to the Vaccine Adverse Event Reporting System, an early warning public health system that helps the CDC and FDA detect possible side effects.

The vast majority (94 percent) of reports were considered nonserious events, including fainting, pain and swelling at the injection site, headache, nausea and fever.

''Given the large number of doses distributed, it is expected that, by chance alone, serious adverse events and some deaths will be reported in this large population during the time period following vaccinations,'' the CDC and FDA said in a statement.

''Experts have not found a common medical pattern to the reports of serious adverse events reported for Gardasil that would suggest that they were caused by the vaccine,'' the CDC concluded.

Hospital files reports

Dr. Blaise Congeni, director of infectious diseases at Akron Children's Hospital, said the hospital has only seen a couple of patients who were concerned that the Gardasil vaccine might have caused serious side effects.

''We filed the appropriate paperwork under those circumstances, because we are committed to seeing that there is one clearinghouse,'' he said.

Congeni said he and other doctors rely on the CDC and FDA to investigate reports and track potential side effects of vaccines.

In a prepared statement, Merck said ''nothing is more important to Merck than the safety of our products, and we carefully monitor the safety of Gardasil on a routine basis.

''Experts at the FDA and CDC also continue to review data and, as recently as four months ago, said, 'Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks,' '' Merck stated.

But Kenzie's family isn't convinced.

The Stow teen was leading a normal, healthy life when she got the Gardasil shot during a routine sports physical in June.

Aside from the initial pain, Kenzie was fine until she started experiencing severe nausea and other flu symptoms toward the end of a family vacation to North Carolina's Outer Banks the following month.

At first, doctors thought she had a virus or food poisoning, her mother said. But her symptoms persisted, causing the already slim girl to lose 15 pounds.

By mid-September, she started experiencing joint pain and numbness and tingling in her legs. In the months that followed, her symptoms progressed to include breathing problems and seizures.

''She would lay on the couch and just moan that she was in pain,'' her mother recalled.

More tests ruled out Guillain-Barre syndrome, a disorder that causes muscle weakness and tingling.

The potentially life-threatening condition is among the serious adverse events that have been reported to the federal government after Gardasil administration. But the CDC has said there is no indication the vaccine increases the rate above that expected in the general population.

A whirlwind of scans, scopes and blood tests during visits to doctors and hospitals throughout Northeast Ohio failed to reveal a reason for Kenzie's problems, her mother said. Some doctors labeled her condition as ''chronic fatigue syndrome'' or simply dismissed the symptoms as being in her head.

''They were treating the symptoms but they had no explanation for what is actually wrong with her,'' Jenna Bear said. ''It's just a nightmare.''

Looking for answers

Kenzie's mother began to suspect a link between the girl's mysterious symptoms and Gardasil after an acquaintance told her about another family with a teen who experienced similar illnesses after getting vaccinated.

She searched the Internet and found stories of other frustrated parents whose daughters were having many of the same problems as Kenzie after getting the vaccine.

But most doctors dismissed the family when they asked whether Kenzie's symptoms might be linked to the vaccine, her mother said.

''The horrible part is nobody wants to talk about the fact that it could be the vaccine,'' Jenna Bear said.

Kenzie said her ongoing illness has caused her to miss most of her freshman year at Walsh Jesuit High School and lose friends.

''A lot of my friends stopped talking to me because they say, 'I got the shot, and I'm fine. You must be faking it,' '' she said.

One local doctor, however, was willing to report Kenzie's case to the federal Vaccine Adverse Event Reporting System for further investigation, her mother said.

And now the family is working with Dr. Ritchie Shoemaker, a Maryland physician who specializes in diagnosing and treating illnesses caused by biotoxins.

Shoemaker said blood tests have confirmed that Kenzie has a series of abnormalities in her innate immune system, a condition that affects less than 1 percent of Americans.

The innate immune system is the body's first line of defense against invading pathogens. People inherit this part of their immune system.

Shoemaker said he is treating two other young women who received the Gardasil vaccine and have ''strikingly similar'' symptoms to Kenzie. Their lab results are pending.

More testing is needed to determine whether other girls and women who say they became ill after getting the Gardasil vaccine share the same immune abnormalities, Shoemaker said.

''Until I have a cohort of 10 or 15 cases, I would not consider that the vaccine has been demonstrated statistically to be implicated,'' he said.

But if it is shown that people with a specific genetic makeup are at risk of serious side effects from a vaccine, Shoemaker said, ''then someone in public health might say, 'Before you have the vaccine, get this gene test.' ''


Cheryl Powell can be reached at 330-996-3902 or chpowell@thebeaconjournal.com.

[]
Kenzie Bear, 15, (left) and her mother, Jenna, in their home. Kenzie has experienced many severe health complications since being given the vaccine to prevent HPV last summer. (Karen Schiely/Akron Beacon Journal) (AKRON BEACON JOURNAL)
View more photos>>

For months, more than a dozen doctors have studied why Kenzie Bear has been so sick.

The once-healthy, active 15-year-old from Stow suffers from constant nausea, debilitating fatigue, seizures and other symptoms that have left her unable to attend school or play sports.

''Sometimes I'm afraid to go to sleep,'' Kenzie said, ''because I'm afraid I won't wake up.''

Now her mother, Jenna, is among a small, but growing community of parents nationwide who are concerned a series of shots meant to protect their daughters from cervical cancer instead might have made the girls incredibly ill.

They're sharing their suspicions about the vaccination called Gardasil in online blogs and chat rooms, as well as in national news stories covering the controversy.

''This is a horrible thing on a mom who signs a paper and says it's OK to give a vaccine,'' Kenzie's mother said. '' . . . They need to stop until they study it more, that's for sure.''

But federal health officials and Merck & Co. Inc., the maker of Gardasil, insist the vaccine continues to be a safe, effective series of inoculations against the sexually transmitted human papillomavirus, known as HPV.

Gardasil protects against strains of the virus believed to be responsible for about 70 percent of cases of cervical cancer, a disease that kills almost 4,000 American women annually.


When the U.S. Food and Drug Administration first approved the three-shot series in 2006 for girls and women ages 9 to 26, medical experts heralded the breakthrough as the first vaccine to prevent a known cause of cancer.

Some critics raised ethical concerns about giving adolescents shots designed to protect against a sexually transmitted disease.

But on its Web site, the FDA indicates that Gardasil ''is an important cervical cancer prevention tool that will potentially benefit the health of millions of women.''

According to the U.S. Centers for Disease Control and Prevention, more than 23 million doses of Gardasil had been distributed nationwide as of Dec. 31.

As of that date, 11,916 reports of adverse reactions following Gardasil vaccination were made to the Vaccine Adverse Event Reporting System, an early warning public health system that helps the CDC and FDA detect possible side effects.

The vast majority (94 percent) of reports were considered nonserious events, including fainting, pain and swelling at the injection site, headache, nausea and fever.

''Given the large number of doses distributed, it is expected that, by chance alone, serious adverse events and some deaths will be reported in this large population during the time period following vaccinations,'' the CDC and FDA said in a statement.

''Experts have not found a common medical pattern to the reports of serious adverse events reported for Gardasil that would suggest that they were caused by the vaccine,'' the CDC concluded.

Hospital files reports

Dr. Blaise Congeni, director of infectious diseases at Akron Children's Hospital, said the hospital has only seen a couple of patients who were concerned that the Gardasil vaccine might have caused serious side effects.

''We filed the appropriate paperwork under those circumstances, because we are committed to seeing that there is one clearinghouse,'' he said.

Congeni said he and other doctors rely on the CDC and FDA to investigate reports and track potential side effects of vaccines.

In a prepared statement, Merck said ''nothing is more important to Merck than the safety of our products, and we carefully monitor the safety of Gardasil on a routine basis.

''Experts at the FDA and CDC also continue to review data and, as recently as four months ago, said, 'Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks,' '' Merck stated.

But Kenzie's family isn't convinced.

The Stow teen was leading a normal, healthy life when she got the Gardasil shot during a routine sports physical in June.

Aside from the initial pain, Kenzie was fine until she started experiencing severe nausea and other flu symptoms toward the end of a family vacation to North Carolina's Outer Banks the following month.

At first, doctors thought she had a virus or food poisoning, her mother said. But her symptoms persisted, causing the already slim girl to lose 15 pounds.

By mid-September, she started experiencing joint pain and numbness and tingling in her legs. In the months that followed, her symptoms progressed to include breathing problems and seizures.

''She would lay on the couch and just moan that she was in pain,'' her mother recalled.

More tests ruled out Guillain-Barre syndrome, a disorder that causes muscle weakness and tingling.

The potentially life-threatening condition is among the serious adverse events that have been reported to the federal government after Gardasil administration. But the CDC has said there is no indication the vaccine increases the rate above that expected in the general population.

A whirlwind of scans, scopes and blood tests during visits to doctors and hospitals throughout Northeast Ohio failed to reveal a reason for Kenzie's problems, her mother said. Some doctors labeled her condition as ''chronic fatigue syndrome'' or simply dismissed the symptoms as being in her head.

''They were treating the symptoms but they had no explanation for what is actually wrong with her,'' Jenna Bear said. ''It's just a nightmare.''

Looking for answers

Kenzie's mother began to suspect a link between the girl's mysterious symptoms and Gardasil after an acquaintance told her about another family with a teen who experienced similar illnesses after getting vaccinated.

She searched the Internet and found stories of other frustrated parents whose daughters were having many of the same problems as Kenzie after getting the vaccine.

But most doctors dismissed the family when they asked whether Kenzie's symptoms might be linked to the vaccine, her mother said.

''The horrible part is nobody wants to talk about the fact that it could be the vaccine,'' Jenna Bear said.

Kenzie said her ongoing illness has caused her to miss most of her freshman year at Walsh Jesuit High School and lose friends.

''A lot of my friends stopped talking to me because they say, 'I got the shot, and I'm fine. You must be faking it,' '' she said.

One local doctor, however, was willing to report Kenzie's case to the federal Vaccine Adverse Event Reporting System for further investigation, her mother said.

And now the family is working with Dr. Ritchie Shoemaker, a Maryland physician who specializes in diagnosing and treating illnesses caused by biotoxins.

Shoemaker said blood tests have confirmed that Kenzie has a series of abnormalities in her innate immune system, a condition that affects less than 1 percent of Americans.

The innate immune system is the body's first line of defense against invading pathogens. People inherit this part of their immune system.

Shoemaker said he is treating two other young women who received the Gardasil vaccine and have ''strikingly similar'' symptoms to Kenzie. Their lab results are pending.

More testing is needed to determine whether other girls and women who say they became ill after getting the Gardasil vaccine share the same immune abnormalities, Shoemaker said.

''Until I have a cohort of 10 or 15 cases, I would not consider that the vaccine has been demonstrated statistically to be implicated,'' he said.

But if it is shown that people with a specific genetic makeup are at risk of serious side effects from a vaccine, Shoemaker said, ''then someone in public health might say, 'Before you have the vaccine, get this gene test.' ''


Cheryl Powell can be reached at 330-996-3902 or chpowell@thebeaconjournal.com.