Wednesday, September 30, 2009

Schoolgirl’s Death After Cervarix HPV Shot Raises Questions about Screening for Underlying Medical Conditions

Britain’s HPV vaccination program was suspended yesterday and a 200,000-shot batch of Cervarix was recalled after 14-year old Natalie Morton turned pale and collapsed after being vaccinated. She died in hospital just hours later.

Because of the implications of her death, an autopsy was performed very quickly at University Hospital in Coventry, England. Initial results indicate that Ms. Morton’s death was a result of an "underlying medical condition," although no explanation was given as to why the shot apparently—although not definitely—precipitated Ms. Morton’s death.

Questions about rare adverse events associated with both Cervarix and Gardasil frequently center on the difference between causality and the trigger effect. Both Cervarix and Gardasil, for instance, have been associated with autoimmune diseases, which arise in genetically predisposed individuals but require an environmental trigger such as chemical exposure or a vaccination.

Take fifteen year old Jenny Tetlock, who apparently had a predisposition to autoimmune disease as seen in an early childhood skin condition. She died within two years of onset of a very rapidly progressing ALS-like paralysis that began shortly after vaccination with Gardasil; the autopsy showed that she had damage to her spine that was caused by “neurological disease that was mediated by immune responses.”

Although no definitive link with Gardasil has been made, the question still looms large in the minds of concerned scientists, doctors and parents—even if Gardasil didn’t definitively “cause” Ms. Tetlock’s death, did it trigger it? And if so, how do we stop that from happening again? Can we, and should we, insist on a better screening process to find individuals likely to be adversely affected by immunization?

The VAERS passive surveillance system reports eleven cases of cardiac arrest after vaccination with Gardasil. The Advisory Committee on Immunization Practices recommended back in 2003 that military personnel with known underlying heart disease or cardiac risk factors, such as diabetes or a smoking habit, should NOT be given the smallpox vaccine after it was associated with increased cardiac “events.”

And the FDA has found a slightly increased risk of blood clots to be associated with Gardasil, which should raise questions for girls who are on the Pill; and when two girls in Spain suffered repeated convulsions for months after being given the vaccine, an investigation found that the convulsions weren’t caused by Gardasil but could have been triggered by it.

Meanwhile, Dr Caron Grainger, joint director for public health for the National Health Service Coventry and Coventry city council, simply said in a statement: “The preliminary postmortem results have revealed a serious underlying medical condition which was likely to have caused death. We are awaiting further test results which will take some time. However indications are that it was most unlikely that the HPV vaccination was the cause of death.”

NHS officials urged parents not to be alarmed and to allow their children to be vaccinated when the Cervarix program resumes next week. Girls aged 12 and 13 in British schools are given the HPV jab in school unless their parents specifically object. The batch of Cervarix that was used for Natalie Morton’s vaccination has been returned to GlaxoSmithKline for further testing, and schools are awaiting fresh supplies.

Cervarix and Gardasil are both new vaccines against the human papillomavirus, which is usually shrugged off by the immune system but can, in a very tiny percentage of cases, cause cervical cancer and (even more rarely) penile, esophageal, anal or testicular cancer. The vaccines use genetically engineered VLPs (virus-like particles); Cervarix protects against two oncogenic strains of HPV and uses a novel adjuvant, AS04; while Gardasil uses an aluminum adjuvant and protects against two oncogenic strains and two genital wart-causing strains.

Vaccination programs usually work on the “greater good” principle, with the idea that a few patients might experience adverse side effects, even death, but lives will be saved overall. Merck has been widely criticized for its heavy-handed over-selling of Gardasil, notably in last month’s JAMA.

What do you think? Could we do a better job of screening individuals prior to vaccination rather than adopting a “one size fits all” policy?


Anonymous said...

My strong healthy hyperactive 35year (not underweight, not overweight) 35 old wife had the first shot of Cervarix (Gardasil equiv) in mid Jan 2010 and is having a severe reaction since then. This vaccine really messes up the metabolism and the immune system. This is what she suffered:

Dizzyness, frequent headache, joint pain, frequent fever, throat infection, dry upper/inner mouth, flutters in ear, severe weakness, irregular and messed up period and most importantly (this was the clue) massive loss of body fat in a very short period of time. The skin of her hands started shriveling like an old woman (hint: sub-cutaneous fat). Dry skin and mild rashes all over. She was so weakened that she was almost bedridden for a few days.

Good thing is that now she is regaining strength and on the way to recovery. This is what we and our good family physician (specialist in Internal medicine and gastro-entr) had to do.

1. MUST: Don't eat any wheat products. Eat rice instead. Stop any form of dieting and go to full nourishing meals.
2. Drink lots of water, 4 glasses of fresh fruit juice every day. Drink coconut water if you can get it.
3. Lots of butter, yogurt, curd, full-cream milk, fish. Have two country chicken/duck eggs everyday
4. MUST: A good multivitamin, specially vitamin B-Complex syrup (Polybion) 3 times a day
5. Plenty of vegetables, specially carrots and beet-root (semi-boiled)
6. Try to maintain basic physical activities but do not exert. Take good rest.
7. Eat fish
8. Sesame seed paste (mix with milk shake/yogurt)
9. MUST: Have this "muscle builder" supplement 3 times a day for 5 days (no more): "Carnitin Ornitate" (may be available under different brands).
10. Get a good protein supplement with essential amino acids.

According to our doctor, the full recovery would take a month or two.

This post may help others to cope with the after effects. The treatment may already be known to many doctors but I could not find any on the net. Hence the posting.

Always consult a "really good expert" specializing in Internal Medicine and Immunology. I mean the type of doctors (a rarity these days) who have not yet lost their brains (and heart), who try to understand things in terms of the underlying body chemistry and keep themselves updated with research and open issues. If you think the doctor is not paying attention to the effects/suffering and is dismissing you after routine stuff, change the doctor immediately. He/she probably does not know any more than what has been spoon-fed by the Merck/GSK sales folks.

And when you recover, get together with others and sue the living daylights out of GSK and Merck. I am very sure they fudged/cooked their clinical trial reports or what they tried is not what they are selling. Enron of medicine? Why not. The vaccine may or may not be effective against HPVs (time will tell) but the way they have set the dose and the turbo-charged it with the adjuvents, definitely does not suit all human beings.

PS. If your body already shows such a violent reaction, do not go for the next injections. Your immune system will remember this viral-protein till you die at a ripe old age.

Anonymous said...

Quick detection and treatment is the key. Yes the CNS can repair itself for any small damage but if you are late and have received multiple shots already then it may be bit late. You can still recover partially.

Update on my wife's treatment and progress (2 months since first Cervarix dose in mid Jan 2010):

Intial Treatment:
To overcome the intial wave of neurological disorder symptoms (that feels like "I am dying out of exhaustion, headache , vertigo and I don't know what I am doing"):

3 times a day for 5 days (no more): \u201cCarnitin Ornitate\u201d (may be available under different brands). Mix the powder with milk shake.

Supplements and Diet:
1 capsule daily: "CoQ Forte" (100mg co-enzyme Q10 per cap)

4-6 capsules daily: "Mega-3" (fish-oil derived EPA+DHA combo, around 400mg each capsule).
If the fish smell is too much then a poorer alternative is: "Oxyflax" (1000mg flaxseed oil per cap). Take 3 of those.

2tbsp twice daily "Polybion" syrup (B-Complex)

1 tab "Supradyn" daily - a good multivitamin+mineral+trace elements from Bayer.

1. Must avoid anything made/derived from wheat (basically no gluten, as it showed adverse reaction in her. Also there are some research on neurotoxicity involving it). Take rice and rice derived stuff. Avoid bread, cakes, pastries.

2. Avoid eating at cafes/resturants. Most of these places use MSG (mono-sodium glutamate) to sharpen the perception of taste. It is a known neurotoxin.
Cheap roadside eateries may actually be okay as they mostly do not use MSG (also known in India as Aginamoto). Avoid the taste-maker masala powder that comes with Maggi. I think it contains MSG.

3. Avoid foods that can trigger allergic reactions.

4. Try to avoid any antibiotics for few months.

5. Take plenty of fresh fruit juice throughout the day. Drink coconut water.

6. 2 eggs every day. Prefer country/ free-range chicken/duck.

7. Protenix milk shake (use full cream milk).

8. Plenty of curd/yogurt.

9. Take lots of fluid. Avoid getting constipation (a common symptom of de-myelinating disorders like ADEM/Multiple-Sclerosis that are triggered by Cervarix/Gardasil). Keep an appropriate laxative handy.

10. Not sure about Coffee/Tea (caffeine/nicotine) - my wife drinks neither !

11. Do not bother about weight gain. Your nervous system requires this much material for 3-6 months to repair itself.

Take full rest during the first wave of fatigue attack. Start the treatment.

After you are bit okay, resume some regular activity. Do not overstress.

Severe headache and mild/severe short term memory loss may occur but do not despair. Within 2 months it should improve/recover.

Do not drive (at least in the first few weeks). You may face strange confusion/ lack of confidence while trying to cross a busy road with traffic (hint: minor damage in hind brain). Do not despair, it is not permanent, but for the time being ask someone to help you.

Find a good neurologist who has treated ADEM/MS and other autoimmune cases.
But start the above treatment as soon as you detect the symptoms. Do not wait for the doctor (often too busy, too formal, too dumb, too biased towards GSK/Merck) to run 20 tests for 30 days to confirm what it is. It may be too late to get your brain/nerves back to its original healthy state.