On the issue of cervical cancer, after remembering Jan Hus – and heresy

The other day I tweeted: July 6 1415 Jan #Hus was burnt at the stake in Konstanz DE for #heresy against #doctrines of #Catholic #Church http://t.co/lM1SlwF

So what, you think to yourself? Okay, sure, you and many others have other things to be concerned about – and who cares about a 15th century heretic? Well, maybe some of us do, and I might on this occasion talk some heresy myself. How ’bout that?

But first, let’s be clear about what heresy is, and what Jan Hus’ heretic speech was about, very briefly. This, in case you don’t read the Wikipedia article http://t.co/lM1SlwF about the medieval thinker, a Czech priest, philosopher, reformer, master and rector at Charles University in Prague, chaplain to the royal court, confessor to the queen,  a key predecessor to Luther and the Protestant movement of the 16th century. It was only some 150 years later that “in 1567 Pope Pius V canceled all grants of indulgences involving any fees or other financial transactions” [indulgence = remission before God of the temporal punishment due for a sin after its guilt has been forgiven].

Master Jan Hus Preaching At the Bethlehem Chapel by Alphonse Mucha, 1916

The Czech king (“Good King Wenceslas” of the English Christmas carol fame) supported Hus preaching against indulgences and other such corruption of “the substance and spirit of the gospel“, but the church’s hierarchy, having declared war on Naples, needed vast revenues to fund the war effort… When the sales of indulgences continued, riots broke out in Prague. Three pro-Hus students were beheaded, and then buried to public acclaim in the Bethlehem Chapel. The hierarchy countered by excommunicating Hus (for the second time). The archbishop “interdicted” the city; that is, he deprived the people of al the spiritual resources of the church, a terrifying development in the middle ages.

This is citing from http://www.victorshepherd.on.ca/Heritage/Jan Hus.htm ; there too you can get the rest of the story about the General Council in Constance, which city was then in Switzerland, with Hus guaranteed a “safe conduct”.

You could see at http://dictionary.reference.com/browse/heresy that the dictionary defines heresy as (1) an opinion or doctrine at variance with the orthodox or accepted doctrine, especially of a church or religious system, and (2) as the maintaining of such an opinion or doctrine. In our time, reference could also be to other types of system or establishment.

More to the point of the Master Jan Hus anniversary, and for a scholarly treatise on the punishment that the medieval intellectual received from the then establishment, treat yourself to http://en.wikipedia.org/wiki/Death_by_burning .

Preparing_the_execution_of_Jan_Hus --- Müller-Baden, Emanuel (Hrsg.): Bibliothek des allgemeinen und praktischen Wissens, Bd. 2. - Berlin, Leipzig, Wien, Stuttgart: Deutsche Verlaghaus Bong & Co, 1904.

For, now that I gave you a preamble, I’ll go into a bit of potentially or mildly heretical talk myself, in relation to cervical cancer (and other STDs, sexually transmitted diseases). It is not heresy to remind ourselves that the HPV vaccines do not cure cervical cancer nor do they prevent infection by all strains of HPV – but it could be heretical to discuss that there has been a grave concern among the public about adverse effects, injuries and even deaths in some young recipients of the vaccines.

And even more so to point out that behavior control (the personal health practices referred to below) is advisable in view of the fact that the cancer is associated with early start of sexual activity and with promiscuity. “It is well known that more than 90% of cases of anogenital warts are caused by HPV. HPV has been implicated in cancers of the cervix, vulva, vagina, penis, anus, and oropharynx. The virus is a necessary cause of cervical cancer. [Note that] as many as 24 million American adults–that is, 1 in 5–may be infected with HPV.”

Sadly, and dangerously for the health of all of us, the above-cited phrase about “It is well known” is misleading because it pertains only to medical people (not even to all of them) as opposed to the general population. “Knowledge about the relationship of HPV to cervical cancer is low even in the United States and the United Kingdom.” One of the sources, on which this assessment is based, concludes: Cervical cancer risk factor knowledge, especially knowledge about HPV is low, even among women with the history of cervical cancer. Younger and more educated women are more likely to have HPV and cervical cancer knowledge accuracy. The importance of personal health practices and the focus on health education should be equally emphasized to achieve successful cancer prevention through vaccination. [Emphasis mine.]

In May, @bioZhena tweeted some on this subject. –

@bioZhena:                                                                                               Can #cervicalcancer #screening be done #simply at home as part of a precise determination of #fertile days? http://to.ly/xEO #womenshealth

@bioZhena:                                                                                               Why is it important to do regular #cervicalcancer #screening – besides the fact that #Merck says so? #Gardasil Why the Ovulona? http://to.ly/xEO

RT @BelievnTomorrow Julie Hewett by @bioZhena:                        The Pope, Condoms and HPV: What Pope Benedict May Not Know #PreventCC #HPV http://ow.ly/4Vo4W

@bioZhena:                                                                                            #fem http://bit.ly/k7As90 GARDASIL does NOT prevent all of #cervical #cancer Merck says: It’s important to continue regular #cervicalcancer #screening

@bioZhena:                                                                                     #Gynecology experts divided http://to.ly/awuh whether deaths & blood clots serious but rare side effects of the #HPV #vaccine #Gardasil #fem

@bioZhena:                                                                                       #Gardasil unexplained death http://to.ly/aB9A Coroner raises questions about #HPV #vaccination ¬es 78 US deaths related to Gardasil (51 by CDC)

@bioZhena:                                                                                               The Truth About #Gardasil http://to.ly/awu9 by @mariangreene04 No known treatment to help these girls as they suffer in silence #womenshealth

@bioZhena:                                                                                                             http://to.ly/awun reports of injury, death related to #Gardasil #HPV #vaccine It prevents positive #Pap – not CC [Cervical Cancer] Think Ovulona http://to.ly/xEO  AND THINK ABOUT THE BOLD-FONT STATEMENT JUST ABOVE.

Alphonse Mucha: Madonna Of The Lilies

There then appeared a physician’s tweet “in defense of” the HPV vaccines, dismissive of the public concerns:

@DrJenGunter tweeted:                                                                              @bioZhena don’t use media sources as references, there are excellent reviews of VAERS and Gardisil in real journals

@DrJenGunter tweeted:                                                            @bioZhena all the US deaths post Gardisil have been investigated and no causal relationship identified. Several good publications.

@bioZhena responded with a request for the source of the info, i.e., for those “several good publications”.

@bioZhena:                                                                                              Thanx @DrJenGunter for your msg on #Gardasil #Cervarix safety. Would you share references? I got CDC http://to.ly/aB3v                8% VAERS were serious (defined) = 1,468.

@bioZhena:                                                                                @DrJenGunter #Gardasil http://to.ly/aB4c ~half the adverse reactions required a trip to the ER & about 20% of those girls “Did Not Recover”

@bioZhena:                                                                                                 RT @DrJenGunter: @bioZhena 2011 meta analysis in peer reviewed journal > 44,000 girls no increase in adverse events with Gardasil vs. control #vaxfax — Any chance that you’d share the 2011 meta analysis reference, please?

@bioZhena:                                                                                             #Gardasil Gardisil Silgard Re: @DrJenGunter 2 @bioZhena “don’t use media sources as references, there are excellent reviews of VAERS and Gardisil in real journals”. Please cite them disproving deaths, harm. Email:  vaclavkirsner@yahoo.com . I look forward to hearing from you. Hard data is indeed necessary.

Did not receive any, unfortunately.

Meanwhile, the government’s Centers for Disease Control and Prevention – in “Reports of Health Concerns Following HPV Vaccination” http://www.cdc.gov/vaccinesafety/vaccines/hpv/gardasil.html – states, among other things (albeit not “in real journals”):

Blood Clots
There have been some reports of blood clots in females after receiving Gardasil. These clots have occurred in the heart, lungs, and legs. Most of these people had a risk of getting blood clots, such as taking oral contraceptives (the birth control pill), smoking, obesity, and other risk factors.
Deaths
As of February 14, 2011, there have been 51 VAERS reports of death among females who have received Gardasil. Thirty two of these reports have been confirmed and 19 remain unconfirmed due to no identifiable patient information in the report such as a name and contact information to confirm the report. A death report is confirmed (verified) after a medical doctor reviews the report and any associated records. In the 32 reports confirmed, there was no unusual pattern or clustering to the deaths that would suggest that they were caused by the vaccine and some reports indicated a cause of death unrelated to vaccination. END QUOTE.

Whereupon @bioZhena suggests: The anti-Hippocrates harm does not go away, and cervical cancer screening is no less needed post-vaccination than without it. That’s why @bioZhena’s interest in the topic, as we propose to introduce a better screen than the Pap – but this requires some funding. With our screen done automatically by women at home (in the background of the primary use of the Ovulona™ monitor), the concern that the Pap frequency would suffer in the West is or can be answered, and providing the screen to the population in the non-West countries is a big plus.
Posted by: http://twitter.com/bioZhena   5/26/2011 12:48:52 AM from Twitzer

@bioZhena:                                                                                                  India halts #HPV #vaccine trial after 6 girls die, US does nothing – 67 deaths http://to.ly/aALf #Gardasil & #Cervarix #cervical #cancer

@bioZhena:                                                                                       #vaxfax #womenshealth Worth repeating: Vaccination does NOT replace routine #cervicalcancer screening – does NOT protect against all #HPV types http://to.ly/aB3v And: Vaccines do NOT cure cervical cancer

@bioZhena:                                                                                              #HPV #PreventCC even vaccinated must screen4CC [must screen for cervical cancer]: 20-30 yrs old screen every 2 yrs, 30-65 yrs every 3 yrs if Pap is normal http://to.ly/aGu3

RT @MedscapeOBGYN by @bioZhena:                                             Cervical Cancer Screening Every 3 Years for Most Women http://bit.ly/mhop42

@bioZhena:                                                                                              #Vaccination does not replace routine #cervicalcancer screening! Vaccines don’t protect against all #HPV types http://to.ly/aB3v & they don’t cure it

Alfons Mucha, Malířství

@bioZhena:                                                                                     Comment from http://to.ly/aCD3 #Cervical #cancer “smear tests are invasive uncomfortable embarrassing & often are badly diagnosed”. Hear hear!

@bioZhena:                                                                                                  Comment from http://to.ly/aCD3 “De-stigmatize #cervical #cancer and do some work to make test less unpleasant – more #women will go”. Hear hear!

@bioZhena:                                                                                       #womenshealth RT @BelievnTomorrow #HPV and #cervical #cancer – (We can do better!) http://ow.ly/506ha ->Easy home screening http://to.ly/weK

@bioZhena:                                                                                                e-tech #medtech 4 getting #women everywhere screened 4 early signs of #cervical #cancer http://to.ly/aGtS  Innocuous, affordable.

That’s it – we can do better than the Pap.

But does anyone hear this?

@bioZhena:                                                                                             What is the significance of the #HPV epidemic? http://to.ly/aB44 Already in 1842 a Verona #doctor observed: #cervicalcancer is due to sexual activity http://to.ly/aB46

#Women who get #STD screening can avoid #infertility caused by #STDs http://to.ly/aIyq  Future home screen http://to.ly/xEO http://yfrog.com/kfgl0dfj

@bioZhena:                                                                                              Here is a thought. Daughters of @BarackObama too will benefit from our #medtech #fertility #cervical #cancer screen. See about the Ovulona at http://to.ly/xEO

Is this a heresy?

Comment on Female sexual dysfunction treatment options

An excellent overview post appeared on the KevinMD.com blog, titled Female sexual dysfunction treatment options, written by Jill of All Trades, MD: http://www.kevinmd.com/blog/2010/05/female-sexual-dysfunction-treatment-options.html .

It is worthwhile to capture the introductory paragraphs of Jill’s post here:

Female sexual dysfunction has been reported in up to 40% of women, and described as causing actual distress in approximately 12% of women.

Michelangelo, The Last Judgment, 2 cropped

Therefore, it is an important topic to familiarize with and screen for as a primary care physician, as many patients may not report these symptoms unless they are elicited during the history taking process of the patient encounter. Female sexual dysfunction is often multifactorial and complex; it is affected by such factors as depression and anxiety disorders, life stressors, interpersonal conflict between the couple, medication side effects, age, religious concerns, personal health, privacy issues, personal body image, substance and alcohol abuse, and hormonal influences.

In order to understand the necessary treatment options, it is important to understand the normal female sexual cycle. There are four phases:

1. Libido: the desire for sexual intimacy, through images or thoughts.

2. Arousal: the increase in heart rate, blood pressure, and respiratory rate, along with increased genital blood flow.

3. Orgasm: the peak of sexual pleasure, with rhythmic contractions of the pelvic muscles.

4. Resolution: the return to baseline with pelvic muscle relaxation.

Michelangelo The Last Judgment

The author then very nicely and concisely reviews the treatment options.

I posted the following comment, which at this writing was “awaiting moderation”. –

Thank you for an excellent overview.

I envisage that our Ovulona™ personal vaginal monitor (https://biozhena.wordpress.com/2007/12/11/the-ovulona™ ) will do two useful things for peri-menopausal women and their physicians (https://biozhena.wordpress.com/2008/10/06/ovulona-is-not-another-ovulation-kit ):

#1. Detect effect of any treatment on vaginal tissues and thus allow for personalization of therapy, titration of medications); and

#2. Allow vaginal delivery of therapeutic compounds.

The Ovulona should become a friendly companion tool for all women, to be routinely used from adolescence to peri-menopause (not only for reproductive management, its primary – or certainly initial – purpose).

Ref.: https://biozhena.wordpress.com/2007/12/18/menopause-hrt-and-biozhena/

Regards,

@bioZhena

Michelangelo, The Last Judgment, 2

To this, for the purpose of bioZhena’s Weblog, I would add a reminder about the significance of the problem of (tissue) atrophy, which the reader will find in The Alphabet of bioZhena (under A in the article titled Atrophy) at https://biozhena.files.wordpress.com/2007/11/aaee-the-alphabet-of-biozhena.pdf .

Atrophy means a wasting away, deterioration, or diminution, any weakening or degeneration (especially through lack of use). Read the article, you’ll see about genitourinary atrophy that leads to a variety of symptoms (in both sexes), affecting the quality of life.

And more, including about “estrogen therapy, which is invariably successful in reversing the atrophic problems. Relief from these problems often results in significant improvements in general well-being.”

In my comment above, #1 (detect the effect of treatment on vaginal tissues), the need for personalization of estrogen therapy is reflected, which requires the end-organ effect measuring tool that we provide. See also under E for End-organ effect in the Alphabet of bioZhena at https://biozhena.files.wordpress.com/2007/11/aaee-the-alphabet-of-biozhena.pdf .

Critique of birth control efficacies in NFP as published by Marquette University researchers

Comments on a report of two studies http://www.usccb.org/prolife/issues/nfp/cmr_winter-spring09.pdf – they report on what we will call peri-ovulation methodologies.

JUST LIKE THEIR PREVIOUS REPORT IN 2003 [http://www.nccbuscc.org/prolife/issues/nfp/cmrsumfl01.htm ] OF A STUDY WITH THE PERSONA MONITOR, “LIMITATIONS” OF THE TWO STUDIES THEY REPORT ON ARE POINTED OUT BY THE AUTHORS.

Michelangelo – The Drunkenness of Noah

Excerpts from their first study:

The retrospective study involved 204 couples (i.e., women with a mean age of 28.6 and their male partners, with a mean age of 30.3) who were taught NFP (by health professionals, physicians and nurses) at four sites in the United States

Table 1. Twelve months total unintended pregnancy rate [number of unintended pregnancies out of the number of couples in given group using the indicated method of NFP]

BBT + mucus                                    5/76                     7%

Monitor + mucus                               4/69                     6%

Mucus only                                       1/29                      3%

BBT + mucus + monitor                     2/25                      8%

Monitor only                                      0/5

Second study excerpts:

The participants for this study came from the same four clinic sites as the previous study and involved 313 couples who were taught how to avoid pregnancy with the EHFM [Monitor] plus CVM [Mucus], and another 315 who used CVM only … The researchers found a total of 28 unintended pregnancies with the EFHM plus CVM group and 41 with the CVM only group… (during 12 months of use)

Monitor + mucus                          28/313                        9%

Mucus only                                  41/315                        13%

QUOTE: “both studies have limitations in that they were not randomized clinical trials”.

In their 2003 study report, they similarly noted study limitations, but there was also the following: “Of interest is the authors’ statement that only 1% of reproductive age women in the Netherlands use NFP as a means to achieve or avoid pregnancy. The respondents in this study were mostly women who previously used oral hormonal contraception. This seems to indicate that a new technological device such as Persona could attract new couples to use NFP.” QUOTE UNQUOTE.

Quite right. Their statement of what “this seems to indicate” is consistent with what we had found (without any financial backing by a large investor like Unilever) in a survey of 5,000 American women at about the time when the Persona was new to the market in Britain. Out of those who would purchase our self-diagnostic electronic device (which does NOT require any chemical reagents and daily peeing for in vitro diagnostic measurement with imperfect measures), 70% were users of artificial contraception – they would switch to our device. This outcome was separate from anecdotal evidence of numerous letters and later emails asking if they could purchase our device for their use in NFP.

With the above quote in mind, we would broaden the conclusion – about new technology attracting new couples – beyond NFP use, and we would refer instead (i.e. more broadly) to fertility awareness based methods.

Now, before someone should glance at the above reported outcomes of the two studies and quickly jump to a conclusion, we must make some common sense observations about those statistics. Some little words.

Kandinsky – Little Words

Should someone want to declare that the above Marquette University reported Monitor had a zero failure rate, then it must be noted that, unfortunately, this was zero out of merely 5 cases. Not comparable with anything else in their publication – and hardly very useful for that reason (and because of the small sample size, too).

Similarly: Table 1 might be read as showing that mucus only is better than BBT + mucus + monitor. This could be “legitimately” considered a valid conclusion since the sample sizes are sort of comparable – if “sort of comparable” were considered good enough (76 and 69, respectively, a 10% difference). But the sample size of mucus only (29) is significantly lower than the sample sizes of the BBT + mucus and of the Monitor + mucus groups.

While the unintended pregnancy outcome of the BBT + mucus + monitor group (8%) is sort of comparable to the outcomes of the two groups with the much larger sample sizes where mucus is accompanied by either BBT or by monitor (7% and 6%, respectively), the only really legitimate conclusion or comment is that sample size matters. That is, if we do not want to compare 25 apples with 72.5 oranges (+/- 3.5) and thus come to questionable conclusions.

If all the groups had sample size of 5 and the percentage outcomes were the same, then the conclusion would be fairly legitimate about the superiority of the monitor – except for the equally legitimate complaint that the sample size of 5 is too small.

Michelangelo – The Battle of Cascina

Statistics are supposed to be about large numbers. At least about sufficiently large numbers. Sample size of 5 is hardly sufficiently large, although it would do for a proof of concept, which here the concept would be that Monitor alone is by far the best. I would go with that hypothesis BUT I WANT IT TESTED RIGOROUSLY IN PROPERLY DESIGNED CLINICAL TRIALS.

The outcomes of the second reported study contradict the outcomes of the first, with Mucus only now showing the highest failure rate of them all (13%), and, topping it off, Monitor + mucus is now even higher than in Table 1 (9% vs. 6%).

Since the sample size is now much larger than in Table 1 (313 vs. 69, i.e., 4.5 times larger) it is legitimately concluded that the second study carries more weight and therefore the failure rate of the Monitor + mucus methodology is more likely 9% than 6%. This is rather unsatisfactory but still better than Mucus alone at the whopping 13% unintended pregnancy rate. The 13% failure rate with 315 couples is more believable than the 3% failure rate with 29 couples in Table 1. About 10.862068965517241379310344827586-times more believable – to be light-hearted about it, per jocum dixi.

Then again, remotum joco: All this makes for a kind of arithmetic that should not occur in medical research.

The following is a graphical demonstration of how numbers can distort perception and understanding. The same Michelangelo’s Battle of Cascina (since he did not do any battle of statistics or technologies!) after an effect that allows the data on the periphery to dominate or simply affect disproportionally that which was in the center of focus.

See in the picture above the man looking intently toward us from the middle of the melee? Now (below) he is tiny compared to what’s around him; much like when – in a study of birth distributions as a function of the day of cycle on which conception took place – the data point outliers are doing the same to the high birth counts, because of inaccurate means of ovulation detection (actually mere estimations) employed in said study.

Michelangelo – The Battle of Cascina – Fish Eye effect -30

While such distortions happen with all imperfect measures of ovulation, the study by John France et al. was discussed in an earlier post at https://biozhena.wordpress.com/2007/12/03/fetal-sex-preselection-%E2%80%93-illustrated/ and in the document attached to that post, https://biozhena.files.wordpress.com/2007/12/fetal-sex-preselection-illustrated.pdf .

We subsequently showed, in https://biozhena.wordpress.com/2008/10/06/ovulona-is-not-another-ovulation-kit/, the effect of doing away with the outlier data points by means of the following diagram, which can be likened to removing the Fish Eye Effect -30 from the distorted Michelangelo picture just above to get back his undistorted Battle of Cascina (with all those naked Florentine soldiers surprised by the enemy while bathing).

Ovulona 3-day fertile window versus old methods’ fuzzy estimation of the fertile period

Now, one more citation from the paper under discussion. QUOTE: The EHFM [Monitor] is a hand held device that reads a threshold level of urinary metabolites of estrogen (estrone 3 glucuronide) and luteinizing hormone (LH; on test strips) and provides the user with a low, high, and peak reading of fertility. The monitor is sold in the United States as a method to help couples achieve pregnancy but can be used as an aid to track fertility. QUOTE UNQUOTE

This statement reflects the thinking in those circles. But note: Because no single hormone determines the beginning and no single hormone determines the end of the fertile window (whether they know this or not) they have to speak of low, high and “peak reading of fertility”. We have previously referred to this as a fuzzy delineation of the fertile window [https://biozhena.wordpress.com/2008/10/06/ovulona-is-not-another-ovulation-kit ].

A little bit fertile, then more, and a peak? That is merely a reflection of not having the accuracy to determine the boundaries of the fertile phase.

Salvador Dali – Metamorphosis of Narcissus

Just like you cannot be only a little bit pregnant, you either can conceive today or not. No such thing as low fertility, only the uncertainty of “low reading”, and of all their readings – including their subjective self-observations. Subjective self-observations refer to the mucus appearance and feel in NFP practice – and if they used that too, the same limitation applies to palpating the cervix.

The most succinct word about all this is as follows:

The old approaches to detecting fertility status are to be referred to as peri-ovulation methods. Where the prefix refers not to the Peri of Persian folklore (earlier regarded as malevolent!) but to the Greek meaning of about, around, near or enclosing – in this case ovulation. Surely, peri-ovulation or peri-ovulatory is a more palatable word than fuzzy.

STOP PRESS

And now, go and check out the 2012 post “The fallacy of ovulation calculators, calendars and circulating-hormone detectors” at https://biozhena.wordpress.com/2012/02/13/the-fallacy-of-ovulation-calculators-calendars-and-circulating-hormone-detectors/