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Posts Tagged ‘side-effects’

Worth Forwarding.

May 26th, 2010 2 comments

http://nephropal.blogspot.com/2010/05/halloween-comes-early.html

Am tired from travel. But this is worth looking into:

A new study by French and British researchers examined 72 new drug therapy studies to evaluate if there was a spin on the conclusions for the benefit of the drug.

“More than 40% of the reports had spin in at least 2 of these sections in the main text.”

Reuters link

Abstract:

Reporting and Interpretation of Randomized Controlled Trials With Statistically Nonsignificant Results for Primary Outcomes

Isabelle Boutron, MD, PhD; Susan Dutton, MSc; Philippe Ravaud, MD, PhD; Douglas G. Altman, DSc
JAMA. 2010;303(20):2058-2064.

Context Previous studies indicate that the interpretation of trial results can be distorted by authors of published reports.

Objective To identify the nature and frequency of distorted presentation or “spin” (ie, specific reporting strategies, whatever their motive, to highlight that the experimental treatment is beneficial, despite a statistically nonsignificant difference for the primary outcome, or to distract the reader from statistically nonsignificant results) in published reports of randomized controlled trials (RCTs) with statistically nonsignificant results for primary outcomes.

Data Sources March 2007 search of MEDLINE via PubMed using the Cochrane Highly Sensitive Search Strategy to identify reports of RCTs published in December 2006.
Study Selection Articles were included if they were parallel-group RCTs with a clearly identified primary outcome showing statistically nonsignificant results (ie, P .05).

Data Extraction Two readers appraised each selected article using a pretested, standardized data abstraction form developed in a pilot test.

Results From the 616 published reports of RCTs examined, 72 were eligible and appraised. The title was reported with spin in 13 articles (18.0%; 95% confidence interval [CI], 10.0%-28.9%). Spin was identified in the Results and Conclusions sections of the abstracts of 27 (37.5%; 95% CI, 26.4%-49.7%) and 42 (58.3%; 95% CI, 46.1%-69.8%) reports, respectively, with the conclusions of 17 (23.6%; 95% CI, 14.4%-35.1%) focusing only on treatment effectiveness. Spin was identified in the main-text Results, Discussion, and Conclusions sections of 21 (29.2%; 95% CI, 19.0%-41.1%), 31 (43.1%; 95% CI, 31.4%-55.3%), and 36 (50.0%; 95% CI, 38.0%-62.0%) reports, respectively. More than 40% of the reports had spin in at least 2 of these sections in the main text.

Conclusion In this representative sample of RCTs published in 2006 with statistically nonsignificant primary outcomes, the reporting and interpretation of findings was frequently inconsistent with the results

Statistical proof of what we’ve been saying all along.  We can make studies say what we want.

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The Smear Campaign Continues: Acupuncture “does not relieve” Childbirth Pain

April 28th, 2010 2 comments

Firstly, I’d like to apologize for not posting for two weeks. I’ve been travelling a lot through Hong Kong and China. I will blog more on some observations I’ve made while in Hong Kong as soon as I get some of my photographs uploaded to my laptop.

Speaking of Hong Kong, I am beginning to wonder if there is some grand plot to discredit acupuncture in Hong Kong. First comes the “letter to the editor” concerning acupuncture spreading disease (http://qi-spot.com/2010/03/20/new-bashing-technique-acupuncture-causes-disease/) and now this.

“Acupuncture does not relieve childbirth pain” (http://www.guardian.co.uk/society/2010/apr/28/acupuncture-childbirth-pain-study)

I am the first person in the world to admit where acupuncture is one big FAIL (such as in colour blindness). But I would like to call the attention of the reader to the weasel wording evident in this smear campaign of a headline.

Look at the title. “Acupuncture does not relieve childbirth pain.” What does this imply to the reader? It implies that acupuncture has no effect at all on the pain felt by mummy.

Yet the sub-title below the headline betrays a hint of the truth:

“Research suggests results from complementary therapy during labour may be placebo effect”

Now, we have no idea, based on this sub-headline if this is a single study or a meta-analysis.  As we have said before, a meta-analysis is a fancy way of saying, “let’s put different studies together just to get the numbers up.  We can always find a way to put the studies together that the sum total numbers can be made to say whatever we want.”

Secondly, it “suggests” (whatever that means) that the results may be placebo effect.  Wait.  Results?  RESULTS?  I thought that acupuncture “does not relieve” childbirth pain?  So if it is useless, why are there “results”?  That means there WAS relief of pain.

So why come up with a headline saying otherwise?  Because the results “may” be placebo effect.

pregnacy The Smear Campaign Continues: Acupuncture does not relieve Childbirth Pain

Actually, I wouldn't use those points in pregnancy... but what the heck. Then again, he just might be some really fat guy...

The finding, which has already prompted a vigorous debate about the value of acupuncture, came from British and Korean researchers who examined previous studies of its use in labour.

“The results show that there is little convincing evidence that women who had acupuncture experienced less labour pain than those who received no pain relief, a conventional analgesia, a placebo or sham acupuncture,” researchers told BJOG: An International Journal of Obstetrics and Gynaecology. The journal is owned by the Royal College of Obstetricians and Gynaecologists, which represents most of the UK’s doctors specialising in childbirth and maternity care.

The finding, which has already prompted a vigorous debate about the value of acupuncture, came from British and Korean researchers who examined previous studies of its use in labour.
“The results show that there is little convincing evidence that women who had acupuncture experienced less labour pain than those who received no pain relief, a conventional analgesia, a placebo or sham acupuncture,” researchers told BJOG: An International Journal of Obstetrics and Gynaecology. The journal is owned by the Royal College of Obstetricians and Gynaecologists, which represents most of the UK’s doctors specialising in childbirth and maternity care.

So it IS a meta-analysis.  Strike one.  I wonder what points were used? Hmmm…

Prof Edzard Ernst, of the Peninsula medical school at Exeter and Plymouth Universities and co-author of the report, said: “The effects of acupuncture perceived by women are largely due to placebo. Acupuncture has many qualities that maximise placebo effects: it involves touch and is invasive and, psychologically, is attached to the mysticism of the east.”

Ernst is a known skeptic of acupuncture and makes a living (i.e. buy his book!) by bashing it.  Then again, I make my living healing patients with it, so I guess we cancel each other out.  Still, he admits that acupuncture DOES have an effect, it’s just that he either cannot or will not recognize the evidence that acupuncture DONE PROPERLY is more than placebo. (http://qi-spot.com/2010/04/04/a-study-to-look-forward-to-acupuncture-more-than-just-placebo/)

I would like to point out that even in western medicine, there exist drugs for which the mechanism of action is unknown.  Lithium is used for bipolar disorder and it is not known how it works.  Yet it is given, despite toxicity, because it has been observed to work.  I leave it to the reader to witness where the double standard lies.

Also, I find it disturbing that people will look down (albeit unintentionally) on patients’ experience just to pooh-pooh acupuncture.

Prof Philip Steer, BJOG’s editor-in-chief, said labour pain can be so intense that a women would do anything to minimise it.

Please, by that logic we can get a shaman in pyjamas to conduct ritual chants and that would work.  Yet it doesn’t, and acupuncture does.

“Acupuncture is a drug-free approach and that may explain why some women prefer its use during labour. This review shows that in a very small number of cases acupuncture may be of help, usually for short periods of time after treatment, and this may be down to psychological rather than a physiological effect. Generally the consensus is that the evidence does not support its use.”

The only benefits were 11% less pain in the first 30 minutes after receiving acupuncture and a need for less pharmacological pain relief, the authors say.

Wait wait wait.   The “only” benefits? So “they” begrudgingly admit that there are benefits!  Back to my first question: why the irresponsible headline, then?  The last part of the sentence betrays the answer:

“…a need for less pharmacological pain relief” – in english: LESS DRUGS.

Less drugs, less profit for big pharma.

I will skip to the last part:

Mike O’Farrell, chief executive of the British Acupuncture Council, said: “We’re surprised by these findings as previous trials, along with the evidence that our members see in their practices every day, suggest that acupuncture can be effective in providing pain relief in many different circumstances.”

Again, as I have said before, people not biased by big pharma can see where acupuncture works and it doesn’t.  I am happy to report, both first hand and through correspondence with other OB-Gynecologists even in the US, that acupuncture can work in reducing childbirth pain IF DONE PROPERLY.

My final thoughts: this article should have been entitled “Acupuncture apparently no better than placebo” instead of “Acupuncture doesn’t work”.  News bias, bah humbug.

Campbell, Denis.  ”Acupuncture does not relieve childbirth pain” The Guardian.  28 April 2010.  <http://www.guardian.co.uk/society/2010/apr/28/acupuncture-childbirth-pain-study> Accessed 28 April 2010
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New Bashing Technique: Acupuncture Causes Disease?

March 20th, 2010 4 comments

This is a new low.  Hitting below the belt.  No, taking a jackhammer and hitting below the belt.

“Acupuncture Spreads Disease” (http://www.theage.com.au/lifestyle/wellbeing/acupuncture-spreads-disease-20100319-qjgo.html)

My first reaction is: of course it does.  Just like ANY OTHER MEDICAL PROCEDURE, acupuncture CAN spread disease, if done improperly.  But you don’t hear the media say that oh no…

First they say there’s no scientific basis.  Then research destroys that argument.

Then they say there’s no evidence.  Then research shows otherwise.

Now they have to scrape the bottom of the barrel just to discourage people from a safe (if done properly) procedure with less side effects (if any) than conventional therapies just so Big Pharma can continue hooking us on drugs.

Many people don’t read past the headline.  This headline implies that STANDARD acupuncture spreads disease.  The first paragraph, while finally implying that it is not acupuncture itself but substandard sterilization procedures cause disease, makes you forget that fact by pairing it with HIV and Hepatitis… causing panic in the reader.

Bacterial infections, hepatitis B and C, and possibly even HIV are being transmitted via acupuncture through the use of contaminated needles, cotton swabs and hot packs, experts have warned.

Note that he says “contaminated”.  However, by that time you’ve already read “hepatitis” and “HIV” despite the fact that to get HIV through acupuncture, you hypothetically have to dip the needle in an infected patient’s blood, and while it’s still fresh (HIV dies in dried blood) poke it in ANOTHER patient.

Even the article (begrudgingly, and at the END) says as much.

Although no clear evidence exists to support a link between acupuncture and HIV infection, there are reports of patients with HIV who had no risk factors other than acupuncture,” it said.

Yes, I had heard about this in a lecture where CDC numbers are mentioned.  The number of these reports? uh ONE? (http://www.hivatwork.org/tools/factshts.htm) and that was only because they couldn’t think of any other reason.  Similar to those babies in eastern europe that tested positive for HIV despite having HIV negative mothers – so they couldn’t think of any other reason except contaminated needles.

In an editorial published in the British Medical Journal, microbiologists at the University of Hong Kong said the number of reported acupuncture-related infections worldwide was the tip of an iceberg and they called for tighter infection control measures.
“To prevent infections transmitted by acupuncture, infection control measures should be implemented, such as use of disposable needles, skin disinfection procedures and aseptic techniques,” wrote the researchers, led by Patrick Woo, microbiology professor at the University of Hong Kong.
Uh yes, it’s called clean needle technique.  It’s required for every acupuncturist applying for a license in the united states. (http://www.ccaom.org/cntprogram.asp).
Now about bacteria:
Woo and his colleagues said acupuncture may be risky as needles are inserted up to several centimetres beneath the skin and they warned of a new syndrome – acupuncture mycobacteriosis – in the 21st century.
“This is an infection caused by mycobacteria that rapidly grow around the acupuncture insertion point as a result of contaminated cotton wool swabs, towels and hot-pack covers. There is a long incubation period but the infection usually leads to large abscesses and ulcers,” they wrote.
hypodermic New Bashing Technique: Acupuncture Causes Disease?

oh so THESE don't cause disease if improperly used?

“So far, more than 50 cases have been described globally. In most cases … bacteria were transmitted from the patient’s skin flora or the environment because of inadequate skin disinfection before acupuncture,” they wrote.
So this can happen in ANY penetrative procedure with inadequate skin disinfection.  Why not say “inadequate skin disinfection causes disease” oh! that won’t get people to read the article! That also won’t be bashing acupuncture per se!
There have been at least five outbreaks of hepatitis B virus infection that are linked to acupuncture.
In most of these cases, the sources were infected patients and the virus was transmitted through dirty needles, although in one case, it was the acupuncturist who was the source, they said.
Let’s see in China a good number of patients are already Hep B positive.  How do we know that they didn’t already have it in the first place?  This is also why needles are never to be re-used.  If the physician doesn’t practice good practice guidelines, then blame the idiot not the acupuncture procedure!
Funny about the acupuncturist being the source.  What did he do? Take a needle, jab himself, then jab the patient?

dirty hands 300x210 New Bashing Technique: Acupuncture Causes Disease?

Using these hands with anything can spread disease. Why single out acupuncture?

And finally:
The paper also laid out the possibility of transmission of hepatitis C and HIV via acupuncture.
Yeah, the “possibility”.  Why, because it doesn’t happen that way.  Geez. Scare tactics.
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More Evidence for Red Yeast Rice!

October 29th, 2009 No comments

Three days ago, I wrote an article about red yeast rice and it’s popular derivative drug Xue Zhi Kang. <http://qi-spot.com/2009/10/27/red-yeast-rice-for-cholesterol-fermented-fun/>.  Now, Medscape has put online a study about it.  Here it is with the usual highlights and commentary:

Red Yeast Rice and Hyperlipidemia: How Strong Is the Evidence?

3-Hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors, or statins, have proven to be effective in reducing lipid levels and improving the risk for cardiovascular disease. However, many patients may not tolerate statins over time, partly due to statin-associated myopathy. Does red yeast rice present a valid alternative treatment for patients with this adverse event? The randomized trial discussed in this review examined the efficacy, safety, and tolerability of red yeast rice among a cohort of patients with a history of statin-associated myopathy.

The significant benefits of statins are hard to refute. These are being reported even among patients at a low risk for cardiovascular disease. For example, in a 2009 study, within 12 months of the initiation of treatment, rosuvastatin was associated with significant regression of carotid intima-media thickness — a strong surrogate marker for cardiovascular events.[1] Moreover, statin treatment among low-risk patients is associated with a reduction in the risk for cardiovascular events. The Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS) examined treatment with lovastatin vs placebo among patients without a history of cardiovascular events.[2] Researchers found that lovastatin reduced the risk for first coronary heart disease events by nearly half over an average follow-up time of 5.2 years. This included a 40% reduction in the risk for myocardial infarction. There was also no significant difference in the rate of severe adverse events when comparing the lovastatin and placebo groups.

In English:  Statins work.  Statins also harm muscles sometimes.  Can Red Yest Rice work for those who can’t take statins?

Sigh, gotta love it.  The question is not “can we use herbal medicine/diet instead of statins” but “can we use them when patient’s can’t tolerate statins”.

The next few paragraphs deal with explaining the very rare side effects of statins.  We’ll leave it to the curious reader to follow the link later on.  Now we focus on red yeast rice!

One strategy in the management of patients with statin-associated myopathy could involve the use of red yeast rice, the fermented product of the yeast species Monascus purpureus grown on rice. It has been used for medicinal and nonmedicinal purposes in China since 900 A.D., and it is promoted there as a means to improve circulation. Red yeast rice contains several compounds collectively known as monacolins, one of which is monacolin K, a powerful HMG-CoA reductase inhibitor and the same chemical as lovastatin. Because of this, red yeast rice has received increased attention in Western countries as a means to treat hyperlipidemia, and there is good research to support its efficacy. In one placebo-controlled trial of 83 individuals with hyperlipidemia, red yeast rice was associated with mean reductions in the concentrations of total and LDL cholesterol of 18% and 22%, respectively, over 12 weeks of treatment.[7] Red yeast rice also reduced serum triglyceride levels by 7% but did not significantly alter high-density lipoprotein (HDL) cholesterol levels. In another placebo-controlled trial, red yeast rice reduced total and LDL cholesterol levels by 27.7% and 21.5%, respectively, and red yeast rice decreased apolipoprotein B levels by 26%.[8]

In English, again – Red Yeast rice was proven to reduce bad cholesterol but not good cholesterol!

To help determine whether red yeast rice may be useful among patients with hyperlipidemia who do not tolerate a statin, the study under discussion in this review compared red yeast rice and placebo among patients with statin-associated myopathy. Patients from one cardiology practice in the United States were eligible for study participation if they were between 21 and 80 years old and had discontinued a statin because of myalgia. Participants’ LDL cholesterol levels were between 100 and 210 mg/dL at baseline, and patients with a serum triglyceride level of 400 mg/dL or more were excluded from study participation, as were those with a history of coronary heart disease.

Sixty-two patients underwent randomization to treatment with 3 red yeast rice 600-mg capsules twice daily, or matching placebo capsules with the same dosing schedule. The treatment period was 24 weeks. All study participants had previously been enrolled in a 12-week trial of lifestyle counseling to prevent cardiovascular disease. The mean age of the participants was 61 years, and 65% of the participants were women. The mean patient weight at baseline was 81 kg. The 2 groups were similar at baseline, except for a slightly higher mean pain score in the placebo cohort.

The main study outcome was LDL cholesterol level, as measured at baseline, week 12, and week 24. The mean values in the placebo group were 165 mg/dL, 154 mg/dL, and 149.8 mg/dL at baseline, week 12, and week 24. The respective levels of LDL cholesterol in the red yeast rice group were significantly better during the active trial period (163 mg/dL, 120 mg/dL, and 128 mg/dL, respectively). This represented a decrease in the baseline LDL cholesterol level of -27.3% at 12 weeks and -21.3% at 24 weeks in the red yeast rice group. Total cholesterol levels were also improved in the red yeast rice vs placebo groups, but there was no treatment difference in HDL cholesterol or triglyceride levels.

Researchers also examined other lipid values and patient weight, as well as specific surveys for bodily pain and laboratory assessments of creatine phosphokinase levels and liver-associated enzymes. There was no significant difference between the red yeast rice and placebo groups in the rate of adverse events and bodily pain, even when the researchers performed a subgroup analysis that was based on the number of statins that patients had previously tried. Four patients discontinued treatment in the red yeast rice group, compared with 1 patient in the placebo group. Creatine phosphokinase and liver-associated enzyme levels remained similar between the groups. Both treatment groups experienced a weight loss of approximately 3.5 kg from baseline.

Again in English: Red Yeast rice caused “bad cholesterol” to go down.  It did not cause any significant difference in both body pain (known statin side effect) and liver and kidney problems between the two groups.

And for their conclusion!

The collective research suggests that red yeast rice is effective and safe in improving the lipid profile among patients with hyperlipidemia. Some research even has suggested that red yeast rice, along with other nonprescription treatment, may be as or more effective than a statin. Becker and colleagues compared treatment with simvastatin 40 mg daily vs combination therapy consisting of enrollment in an intensive lifestyle intervention, fish oil supplementation, and red yeast rice supplementation.[9] The reduction in LDL cholesterol was approximately 40% in both treatment groups, and patients receiving the combination treatment experienced a greater reduction in body weight and serum triglycerides. Although these results are impressive, it is unclear which of the nonstatin interventions was most effective in improving study outcomes.

Red yeast rice does not have the impressive track record of statins in terms of the prevention of cardiovascular events. However, a trial of 5000 individuals with a history of previous myocardial infarction demonstrated that red yeast rice reduced the risk for nonfatal myocardial infarction by 62% and coronary disease mortality by 31% compared with placebo.[10] Red yeast rice also reduced overall mortality by one third compared with placebo.

More research is required with regard to the clinical outcomes of red yeast rice before this treatment can be recommended as an alternative to statins to treatment-naive patients with hyperlipidemia. Concerns about red yeast rice toxicity have been based on monacolin K, the natural lovastatin. Myopathy and rhabdomyolysis,[11,12] similar to that seen with lovastatin, have been reported in case reports. Hepatotoxicity is the main concern, with reports on red yeast rice’s effects on the liver being variable. Some studies have shown theoretical potential for hepatic damage,[13,14] and others have reported no harm in humans.[15] In some animal studies (rats and mice), high doses were tolerated without liver toxicity.[16-18] Because of this finding, statins themselves and any agents that interact with statins should be avoided by those taking red yeast rice.

There are also common questions associated with any complementary and alternative therapy about standardization of the preparation and reimbursement for long-term treatment. However, among special cohorts of patients, particularly those with statin-associated myopathy, red yeast rice appears to be a viable alternative treatment. Physicians should weigh the potential risks and benefits of statins vs alternative treatments for individual patients on the basis of their history of treatment and cardiovascular risk.

Charles P. Vega, MD “Red Yeast Rice and Hyperlipidemia: How Strong Is the Evidence?”  http://www.medscape.com Published: 10/28/2009, Retrieved 10/29/09<http://www.medscape.com/viewarticle/711114>

Vega cites the following as references:

1.  Bots ML, Palmer MK, Dogan S, et al; METEOR Study Group. Intensive lipid lowering may reduce progression of carotid atherosclerosis within 12 months of the treatment: the METEOR study. J Intern Med. 2009;265:698-707.
2. Downs JR, Clearfield M, Weis S, et al. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study. JAMA. 1998;279:1615-1622.
3. Law M, Rudnicka AR. Statin safety: a systematic review. Am J Cardiol. 2006;97:52C-60C.
4. Hansen KE, Hildebrand JP, Ferguson EE, Stein JH. Outcomes in 45 patients with statin-associated myopathy. Arch Intern Med. 2005;165:2671-2676.
5. Avorn J, Monette J, Lacour A, et al. Persistence of use of lipid-lowering medications: a cross-national study. JAMA. 1998;279:1458-1462.
6. Young JM, Florkowski CM, Molyneux SL, et al. Effect of coenzyme Q10 supplementation on simvastatin-induced myalgia. Am J Cardiol. 2007;100:1400-1403.
7. Heber D, Yip I, Ashley JM, Elashoff DA, Elashoff RM, Go VL. Cholesterol-lowering effects of a proprietary Chinese red-yeast-rice dietary supplement. Am J Clin Nutr. 1999;69:231-236.
8. Lin CC, Li TC, Lai MM. Efficacy and safety of Monascus purpureus Went rice in subjects with hyperlipidemia. Eur J Endocrinol. 2005;153:679-686.
9. Becker DJ, Gordon RY, Morris PB, et al. Simvastatin vs. therapeutic lifestyle changes and supplements: randomized primary prevention trial. Mayo Clin Proc. 2008;83:758-764.
10. Lu Z, Kou W, Du B, et al; Chinese Coronary Secondary Prevention Study Group. Effect of Xuezhikang, an extract from red yeast rice, on coronary events in a Chinese population with previous myocardial infarction. Am J Cardiol. 2008;101:1689-1693.
11. Smith DJ, Olive KE. Chinese red rice-induced myopathy. South Med J. 2003;96:1265-1267.
12. Rhabdomyolysis linked to Chinese red yeast rice. Prescrire Int. 2008;17:64.
13. Lu ZL, Xu S, Kou WR. The clinical observation of treatment of hyperlipidemia with different dose of Xuezhikang. National Symposium of Clinical Therapies for Cardiovascular Diseases. 1995;1997:53-57.
14. Wang J, Lu Z, Chi J, et al. Multicenter clinical trial of the serum lipid-lowering effects of a Monascus purpureus (red yeast) rice preparation from traditional Chinese medicine. Curr Ther Res. 1997;58:964-978.
15. Kantola T, Kivisto KT, Neuvonen PJ. Grapefruit juice greatly increases serum concentrations of lovastatin and lovastatin acid. Clin Pharmacol Ther. 1998;63:397-402.
16. Changling L, Yafang L, Zhonglin H. Toxicity study for Monascus purpureus (red yeast) extract [abstract]. Chin Pharmacol Soc. 1995;12:12.
17. Li C, Li Y, Hou Z, et al. Experimental studies on toxicology of Xuezhikang. Commun Chin Pharmacol Soc. 1995;12:12.
18. Blanc PJ, Laussac JP, Le Bars J, et al. Characterization of monascidin A from Monascus as citrinin. Int J Food Microbiol. 1995;27:201-213.

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British Girl Dies After Cervical Cancer Jab

October 3rd, 2009 No comments

Welcome to Qi Spot’s first ever post.  Interestingly it is not about Chinese medicine, so I am classifying this under “Western Medicine”.  Why have I chosen this for my icebreaker?  Well, this blog was actually born out of some discussions over HPV vaccines (I will not call them “cervical cancer” vaccines) and one exasperated colleague’s suggestion that I “write my crazy ideas down”.  So here we have it.

British Girl Dies After Cervical Cancer Vaccine Jab (from Philippine Daily Inquirer)

LONDON – British drug giant GlaxoSmithKline said Tuesday it was working with health authorities here investigating the death of a schoolgirl following a cervical cancer vaccination.

The 14-year-old died on Monday when the Cervarix vaccine was administered at her school in Coventry, central England, as part of a national vaccination to protect women against the disease.

Health authorities have isolated the batch of vaccine used in the school involved against the Human Papillomavirus (HPV), a sexually-transmitted virus which is the primary cause of cervical cancer.

“The incident happened shortly after the girl had received her HPV vaccine in the school,” said Dr. Caron Grainger, joint head of public health for the National Health Service (NHS) in Coventry and Coventry City Council.

Late Tuesday Grainger said test results revealed the teenager had a “serious underlying medical condition” and the vaccination was therefore “most unlikely” to have caused her death.

“The preliminary post-mortem results have revealed a serious underlying medical condition which was likely to have caused death,” she said.

“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.”

The Department of Health said the vaccination program would continue as planned, stressing that more than 1.4 million doses had been given out in Britain and the vaccine had a “strong safety record”.

“The quarantining of this batch is a purely precautionary measure,” a spokesperson said, adding: “The HPV vaccination program can continue as planned — there is no reason for the campaign to be suspended or interrupted.”

In a statement GSK, which produces Cervarix, said it was working with health authorities “to better understand this case, as at this stage the exact cause of this tragic death is unknown.”

It added: “To date the vast majority of suspected adverse reactions (to Cervarix) have related either to the signs and symptoms of recognized side effects listed in the product information or were due to the injection process and not the vaccine itself.”

Awareness of cervical cancer was boosted earlier this year by the death from the disease of a reality television star, Jade Goody, who garnered publicity notably for the need for women to have regular cervical smear tests.

Natalie Morton died a few hours after being injected with a dose of Cevarix.  Strictly speaking, Cevarix and Gardasil are not vaccines for cancer, but for strains of HPV that are supposed to cause cervical cancer.  A recent Journal of the American Medical Association article with a stated objective of summarizing reports from the Vaccine Adverse Effects Reporting System (VAERS) has led the authors to the following findings:

1) There were 12,424 reports of Adverse Effects.

2) Of these, 772 were considered serious.

The reporting rates per 100 000 qHPV doses distributed were 8.2 for syncope; 7.5 for local site reactions; 6.8 for dizziness; 5.0 for nausea; 4.1 for headache; 3.1 for hypersensitivity reactions; 2.6 for urticaria; 0.2 for venous thromboembolic events, autoimmune disorders, and Guillain-Barré syndrome; 0.1 for anaphylaxis and death; 0.04 for transverse myelitis and pancreatitis; and 0.009 for motor neuron disease. Disproportional reporting of syncope and venous thromboembolic events was noted with data mining methods.

Note the word “disproportional”.  Keep in mind that this is a PASSIVE data system, meaning it doesn’t actively seek out side effect reports, but it sits there waiting for doctors to report them.  I am trying to imagine how many more cases out there are unreported.

and 3) There were 32 deaths.

Okay, 32 deaths out of millions of doses given… that’s not very large.  However, what comes to mind is that I have a daughter of my own.  How would I feel if that daughter of mine were one of that 32?  One of the 772 with “serious” side effects?

Of course, I could look at the other side of the fence and think, what if my daughter gets exposed to HPV?  Develops pre-cancerous lesions?

How to balance the two?

There are two factors that make me lean towards avoiding this vaccine for now.

First is the fact that this vaccine is still relatively new.  Thus, it’s long term effects are still in question.  People now do not recall the Polio Vaccine snafu that happened in the 1950s, when it became apparent that Salk’s polio vaccine actually CAUSED more cases of polio.

Second is the fact that the incidence of cervical cancer is actually lowering.  Instead, we have a rise in detection of carcinoma-in-situ (only seen cellularly).  Why? Pap smears, that’s why!  With regular screening, we can find pre-cancerous lesions, treat early, and prevent cancer.  With diseases like Hepatitis B, we don’t have that luxury.

Methinks I will wait ten years before pronouncing HPV vaccines as safe and reliable.

In the meantime, let’s also look at the applicable Chinese Medicine principles here.  Behaviors influence disease.  In the case of HPV, one is most at risk by having promiscuous sex with several partners.  (Well that was redundant… promiscuous sex with several partners…)  Logic dictates that proper behavior not only protects against HPV but other sexually transmitted infections as well.

Final seemingly-unrelated-thought: I also find it amusing that if a person with an underlying medical problem dies and is found to have been infected with H1N1, authorities are quick to assume that H1N1 caused the death by complicating the underlying problem.  Yet, when a person with an underlying medical problem is jabbed with a vaccine and dies, the same authorities are quick to rule out the vaccine as a cause of death because of the presence of the underlying problem.  As my good friend Garrick would say, “Huh?”

pixel British Girl Dies After Cervical Cancer Jab
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