Thursday, August 1, 2013

My Daughter, Cervarix And Scleroderma: What Do They Have In Common? Plus Merck Takes A Hit In Japan Inside Report

My   Daughter,  Cervarix  And  Scleroderma:  What  Do  They Have  In  Common?  

Plus Merck Takes A Hit In Japan Inside Report

My  Daughter,  Cervarix  and  Scleroderma:  What  do  they have  in  common?


Shannon, Invergarry Region, Inverness-shire, Scotland

Story submitted by Linda Stewart, Shannon’s mother


As a parent, I would have never dreamed that a few short months after her last injection of Cervarix my daughter would be diagnosed with scleroderma. We simply thought we were protecting her from having to worry about cervical cancer. This is our story:

Shannon and her twin brother were born prematurely at 35 weeks. She had an operation when she was just a few weeks old to repair the pyloric stenosis she was born with and had eczema when she was a toddler. Apart from these she was always a healthy child.

Shannon has lived in the same small village in the Highlands of Scotland since she was born. She attended the local playgroup, nursery and primary school where she received glowing reports all through her education. She had occasional bouts with hay fever, but takes medication which keeps at bay.

Shannon began the series of three Cervarix injections, marketed to protect her against cervical cancer in March of 2011. She had her final HPV vaccination on 03 August 2011. At the time, we had no idea how rapidly our lives would change.

The week after her last HPV shot Shannon spent a week in Germany with Kilchuimen Academy, the local high school that she attends in Fort Augustus. During the week after her return she fell in school going upstairs to the first floor. When she fell, she hit both her knees on the edge of the stair. When she got home that day, she told me what she had done and showed me her knees, which were both slightly red. The following morning she complained that they were both sore and bruised. I took a look and saw that the bruising on the left knee was from the knee to her thigh.

Over the following weeks Shannon continually complained that her knees didn’t seem to be getting much better. She was starting to have difficulty bending and sitting comfortably.

I was starting to wonder if she had done any damage to her knees when she fell. By this stage, she was also having difficulty putting on her socks and dressing in the morning. I took her to the GP where blood tests were taken and she was referred to Raigmore Hospital, Inverness. There she underwent a 6 week course of physiotherapy. Shannon managed to do some of the exercises that she was given, but others left her in pain.

At this stage, she was coming in from school totally exhausted, making a cup of tea and going directly to her room. I would follow a few minutes later and she would be fast asleep.

In April, she started a part-time job washing dishes in a local hotel. That only lasted six weeks as she was finding it difficult to stand for a long time and was constantly tired. We also noticed that the drain hole in the shower was continually blocked with hair she was losing.

Shannon basically spent the summer of 2011 in her room reading a book or sleeping, shutting herself off from the rest of the world. She had never had a problem with her menstrual cycle before, but her periods stopped in April. Her menstrual cycle did not resume until November, when it came back with a vengeance. In the end, she had to be put on medication to help control the heavy flow. Even so, it took five months for her cycle to return to normal. So far she has had no further problems in this area.

By this time Shannon was in such pain she would not participate in PE at school (I must add that the PE teacher was very understanding). I then returned to the GP who referred her for another course of physiotherapy, despite the lack of success with the first round.

While waiting for the referral date to arrive, Shannon started having difficulty holding her cutlery and cutting her dinner, especially meat. One night at the dinner table, she broke down and showed us her hands. They were starting to curl. She could not make a fist or straighten her fingers. She also could not extend her elbow joint to its full potential.

By this time, my husband and I were both very worried. We made another appointment to have a discussion with our GP. We had seen several articles in the newspapers about girls with symptoms very similar to Shannon’s after their HPV vaccinations. We brought this to the attention of our GP. She subsequently contacted Raigmore Hospital and got us an appointment with Paediatrics and Orthopaedics.

In October 2011, we went to Turkey for a holiday. We had been abroad before and never had any problems. First, Shannon had difficulty sitting on the flight for four hours. She was very tearful and sore as she could not stretch her legs. Unfortunately, she could not lower herself into the swimming pool and had to be helped to get in and out – embarrassing for a teenager. Our apartment was on the first floor and had approximately 15 steps.

Shannon had to take our arms to get up the steps. She spent most of the fortnight in the hotel reception area reading a book as she could not lower herself onto a sun lounger and the water slides were out of the question. Even a daytrip to Bodrum Castle was impossible as there was no way she could climb the steep steps.

When we returned, our first appointment was with the Orthopaedics specialist who said that this was a common problem with teenagers. He sent her for x-rays, but they came back clear. It was explained to him that Shannon’s other joints were now beginning to show problems (i.e. her fingers, toes, etc…). He decided there was no more he could do for her and signed her off.

Eventually we saw a paediatrician at Raigmore Hospital who gave her a thorough examination and more blood tests. In December 2011, Shannon was referred to Yorkhill Hospital, Glasgow. Within several hours of arriving she was diagnosed with a condition known as Scleroderma. This is a very rare condition in children. There were approximately 20 cases in Scotland at the time.

Five days later, after numerous blood tests, heart tests, lung tests, physiotherapy, the fitting and wearing of hand splints, and three days of steroid drips – the stress finally took its toll on Shannon. In her own words,
“It was hard facing the stress of not knowing what was wrong and what the future would hold.”

We arrived home 2 days before Christmas. We made the best of Christmas and the New Year’s celebration before Shannon was admitted to Raigmore for a week’s intensive physiotherapy course. During that week a rheumatology nurse was appointed who explained everything to us.

Over the last sixteen months, Shannon’s life has changed dramatically. Her weekly blood tests are now down to three monthly, which is a relief as finding a vein is a problem. Hydrotherapy appointments are still fortnightly physiotherapy is down to monthly, as long as she does exercises at home. For a teenager, this schedule is difficult. She does have lapses, but luckily her paediatric physiotherapists are brilliant. Steroids are now in tablet form instead of drip, and are being reduced every time we see Dr. Davidson, Consultant Rheumatologist from Yorkhill. Methotrexate is still weekly, but medication is being reduced when she is able to handle the reduction.

This is no life for a previously healthy teenager. Shannon had no symptoms of Scleroderma before taking Cervarix. We are told there is no proof that Cervarix injections caused these problems, but we are provided with no proof it did not cause her problems.

This is our story. We hope it helps you evaluate the risks versus benefits of Cervarix for yourself.

Merck's ($MRK) human papillomavirus (HPV) vaccine Gardasil has enjoyed a strong start to 2013, with sales up 27% in the first half of the year. But Japan's decision to suspend promotion of the jab after it was linked to adverse events has raised some questions about its prospects.

Gardasil generated $140 million in sales in Japan last year, which was less than 10% of the total revenues brought in by the HPV vaccine. Merck is resigned to a fall in sales in Japan this year, with management telling investors the withdrawal of the health ministry's recommendation will have a significant negative impact. Gardasil is still available in Japan but, for now, lacks the health ministry's recommendation. Merck is looking to other markets to offset the loss of sales in Japan. Brazil is adding Gardasil to its national immunization program from 2014, and has set aside almost $160 million for buying HPV vaccines. 

The bigger concern is whether Japan's action will have knock on effects in other markets. Merck is monitoring the situation. "We have not seen any significant impact at this time in other markets around that world," Merck Research Laboratories president Roger Perlmutter told investors. 

The focus now is on continued monitoring of adverse event reports, and presenting data on the safety and efficacy of Gardasil to the Japanese government.

Japan takes a particularly reactive approach to vaccine adverse events. In 2011 Pfizer's ($PFEPrevnar and Sanofi's ($SNY) ActHIB vaccines were both suspended following the deaths of four children. This week the spotlight is on GlaxoSmithKline ($GSK) and Merck ($MRK).

The Japanese health ministry has told local governments to suspend promotion of Gardasil and Cervarix while it investigates adverse events linked to the human papillomavirus (HPV) shots. As of this week, the vaccines are still freely available, but physicians will stop recommending use of the jabs, at least temporarily. The health ministry decision follows reports of people experiencing severe prolonged pain after receiving the vaccines.

An estimated 3.3 million people have received the HPV vaccines in Japan, almost 2,000 of whom have then reported possible side effects, The Asahi Shimbun reports. A ministry task force took a closer look at 43 cases but was unable to establish a causal relationship between HPV shots and symptoms of pain or numbness. HPV vaccines have been linked to more side effect reports than other shots approved at the same time, though. For every million vaccinations with Cervarix, Japanese people have reported 241 side effect cases. In contrast, there have been 67 cases per million Japanese encephalitis vaccinations.

The prevalence of side effects--coupled with high-profile cases, such as a girl who lost the ability to walk after receiving Cervarix--prompted the task force to call for further studies. In the meantime, the ministry is withdrawing its recommendation of the vaccine.

"The decision does not mean that the vaccine itself is problematic from the viewpoint of safety. By implementing investigations, we want to offer information that can make the people feel more at ease," task force head Mariko Momoi said. A ministry official told The Japan Times the HPV vaccination rate is certain to drop sharply while the issue is being resolved.
- here's the Asahi Shimbun article

- read the Japan Times item
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