ENDOMETRIOSIS: When Gynecology does not know that they do not know.

When only 11% of providers can identify the prevalence of endometriosis in the population and >57%. are uncomfortable managing endo, and 75% of patients report being dismissed as neurotic and there are 176,000,000 of them worldwide, we have a crisis.

https://journals.sagepub.com/doi/full/10.1177/2284026520905239

https://www.houstonchronicle.com/lifestyle/renew-houston/health/article/Don-t-know-what-endometriosis-is-A-new-Houston-14080679.php

Couple that with new drug offerings that overstate the impact, "breakthrough treatment" when it is not a treatment at all, coupled with the publishing being done by physicians who in essence work for the drug company in their speaker's bureaus, then edited by the drug company, and the stated impact proven by their own data not to relieve the deep pain it is prescribed for and the crises grow. (David Redwine MD :

David Redwine***

January 6 · 

CONCORDANCE OF HIDDEN DATA EXPLAINS FAILURE OF PAINFUL INTERCOURSE TO RESPOND TO 6 MONTHS OF ORILISSA

Taylor et al, (NEJM 2017;377:28-40) showed in a randomized controlled trial (RCT) that painful intercourse did not respond to 6 months of Orilissa. They also showed that a slight response of painful intercourse seen at 3 months of Orilissa therapy was not sustained at 6 months. This poor outcome was hidden in plain sight in the paper. An RCT is considered the gold standard of medicine. A pronouncement from on high. Especially in the NEJM. It must be concluded that the evidence that was collected per protocol but which was not reported in the paper represented failure since any success would have been emphasized by a drug company interested in selling a drug. Thus making the following conclusion:

PAINFUL INTERCOURSE DUE TO ENDOMETRIOSIS DOES NOT RESPOND TO 6 MONTHS OF ORILISSA.

So why did the FDA approve Orilissa for treating painful intercourse when the RCT they were reviewing showed that there was no response after 6 months of Orilissa? And that a slight response seen at 3 months was gone at 6 months? All the possible answers to this question are bad and cast the FDA as understaffed, illogical or worse and cast the publication above in a deceptive light. But what should we expect when 36% of the authors of the paper were employees or ex-employees of Abbvie who held stock or stock options?

The lack of response of painful intercourse to 6 months of Orilissa is not surprising because the same RCT showed by similarly misleading lack of mention of the negative results that tenderness on exam and nodularity of the posterior vagina on exam did not respond to Orlissa. Such pelvic tenderness and nodularity is pathognomonic for endometriosis - meaning the finding is specific to endometriosis alone. (yes, there are various rare possible scenarios involving cancer in the vicinity which could conceivably produce tender nodularity, but such a finding would be exceedingly rare. I certainly never saw a case.) Since the end of the vagina is hit during intercourse, and since endometriosis is very often just on the other side of the vaginal wall (which is about as thick as your skin), the tissue that is inflamed by the endometriosis is also hit during intercourse. Ouch. So it would be impossible for painful intercourse to improve and pelvic tenderness and nodularity to remain unimproved unless penetration was shallower. So the failure of painful intercourse to respond to Orilissa is concordant with the failures of pelvic tenderness and pelvic nodularity to respond. 

The many authors of the study were brave to so openly and obviously conceal the fact that Orilissa is ineffective for painful intercourse, pelvic tenderness, and pelvic nodularity. I love good science, although when an article is written with deception in mind, you have to find the science between the lines.)***

Add to that the plethora of poorly aimed treatment options: get pregnant, remove your ovaries, let me ablate those lesions, lets do a hysterectomy, we will put you into medical menopause to treat, and since none of those are effective for endometriosis, failure will be 100%. This then leads to unnecessary pessimism in treatment.

https://www.endometriosisaustralia.org/post/2016/09/19/what-does-it-all-mean-excision-ablation-and-robotic-assistance-for-removal-of-endometrios

https://www.ncbi.nlm.nih.gov/pubmed/20129331

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6112593/

Then new diagnostic scanning on the horizon which in skilled hands may be helpful in identifying most disease but enthusiastic endorsement now will mislead much of gynecology to believe endo can be diagnosed with an ultrasound expect more patients to be dismissed as disease-free despite classic signs and symptoms. It is already happening widely in our current state. We have major clinics declaring patients disease-free with negative scans and classic symptoms, who when we refer elsewhere are found to have biopsy-proven endometriosis, often deep disease. Just another tool to gaslight patients and their symptomatic disease. We are currently running a poll which will be anecdotal in nature on the number of negative scans women with biopsy-proven disease when through before finding a surgeon who listened to their history and symptoms and used physical exam and training to determine the patient had a high probability of active endometriosis causing their pain. I will add the data later.

**** simple survey data on scanning revealed:

the anecdotal experience of patients who underwent scans that were negative, in some cases multiple scans and reported missed painful endometriosis found at surgery, confirmed by pathology. We cannot draw percentages but 1035 cases of multiple scans or US alone missed disease. We have to be careful we do not dismiss painful disease based on flawed technology

Erin Luyendyk ran a simple survey for us in Nook

 Neg US: 556 p

Neg CT: 130

Neg MRI: 120

Neg US/CT/MRI: 88

Neg US and MRI: 51

Neg US and CT: 75

Neg CT and MRI: 15

What happened to the gynecologist as a diagnostician? Review of symptoms (see Marc Possover's work on the expansion of symptoms systemically), careful history meaning they have to believe the patient, physical exams, gathering of data, and an assessment of findings, followed by laparoscopy to diagnose and treat with the proper consultants at hand in the OR would be a scientific investigation.

Now we have the move for psychiatric evaluations and assigning dx of central sensitization to patients with active endometriosis left in place, either due to the lack of skills, the lack of knowledge how disabling it can be and the lack of understanding that no therapy will alleviate the pain of endo as long as the active disease remains. Or one would hope the money is not the issue, but insurance companies, HMOs, government agencies all deny access to effective surgery for women and transgender folks with endometriosis. The question becomes is this a value statement on this segment of the population? Live with ineffective therapies because good surgery costs money? Or live with it due to the influence of drug companies over physicians' treatment decisions. Do money and speakers fees influence treatment decisions?

Quick and dirty but ineffective:

https://www.endometriosisaustralia.org/post/2016/09/19/what-does-it-all-mean-excision-ablation-and-robotic-assistance-for-removal-of-endometrios

How do you support giving patients medical therapy that puts them into low estrogen states with the attendant damage to heart, bone and cognitive function? These risks get pushed on down the patients' life spans so no one currently prescribing has any responsibility to inform on the risks for the future or the impact. When these issues develop likely current providers will not be around but patients may experience them in younger ages seriously impacting quality of life and adding substantially to the medical costs of their care in the future by damages done now.

https://www.heart.org/en/health-topics/heart-attack/angina-chest-pain/coronary-microvascular-disease-mvd?fbclid=IwAR0JrOsPLUWmn1bqIbng14jcrE1ZiFW7LQmgNZmEf4_DsqEReLuQSUEB3_Y#.V_-L2DKZPBK

https://www.jmig.org/article/S1553-4650(19)30206-7/fulltext?fbclid=IwAR0tdjCyGU0cH6yJ5eLEEpjBtQYgPLViw4-0HJN5EBT3ZxGHKN1t0wUPnHg

Current worries for men who took lupron and the signs of dementia they are developing do not extend to the millions of women who used lupron and other forms of the GnRH family of drugs. Can you say: The Sounds of Silence? https://jamanetwork.com/journals/jamaoncology/fullarticle/2569059

Last but not least is the "new diagnostic blood tests" developed by a team, members of which are AbbVie consultants and published as science by that team without adequate information on the links between the test and using medical therapy to treat endo once "diagnosed " with the blood test. A test yet to be truly determined reliable but growing in use, with more gaslighting of patients with marginal evidence and conflicts of interest declarations generally missing. Your "test" is diagnostic, lets put you into medical menopause to "treat", (once again a low estrogen state with long term adverse health impacts.) This test has yet to be proven in clinical trials.

Patients now reporting being diagnosed with endometriosis with Receptiva testing, but the small print at the bottom of the page notes it has not been submitted to regulatory agencies for documentation. https://receptivadx.com/women-families/about-receptiva-testing/

It is little wonder outcomes are poor, we are doing nothing that actually treats endometriosis if we are not expertly removing disease. We fail patients by relying on marginal tools to diagnose: uncertain quality blood tests, scans with limitations, limited understanding of the true symptom profile of this disease, comparing poor quality surgery instead of expert surgery with medical therapy and declaring outcomes the same when nothing could be further from the truth. Self-described endometriosis experts without a command of the true symptom profiles, the evolution of color appearance of the lesions, the statistical distribution of disease, adequate skill acquisition and team members for the extra pelvic disease will fail the patient every time creating pessimism in treatment. Treatment that never had a chance at success because the approach was faulty.

Professor Possover's discussion on expanded symptom profiles:

https://www.dhirubhai.net/pulse/endometriosis-expanding-symptom-profile-nancy-petersen/?trackingId=JRCTtVe%2FSOq2l8O9qCztaQ%3D%3D&fbclid=IwAR14xikbd9G8-dz-5JPadtif9lroVJ4WGADNoXu5myfLqAPQo_xnQKV8BQo

Commercial influences in publishing lead us far astray. We see way too much influence in scientific publishing which then gives way marketing within the published articles, lacking true science. This then leads to general gynecology gaslighting patients with marketing materials they thought were science. Medical Therapy: #endometriosis Nancy Petersen: there will be no drug to treat as long as the motivation by big pharma is to fraudulently make money without regard for the injurious nature of the drugs they develop. They misrepresent the value of the drug, twist the data, hide the true nature with court orders to suppress side effect information. There is no treatment that works short of expert surgical excision. https://lnkd.in/eHhdXcd

https://www.dailycal.org/2020/03/03/medical-gaslighting-epidemic-in-womens-health-myths-of-period-pain-require-academic-discussion/?fbclid=IwAR2QfxIbvCXoYTOo5I8sZNRVhgmqDBshUCw_OqswY6OhVz1bf2dOaV9IneM

https://www.bmj.com/content/367/bmj.l6576?fbclid=IwAR0Q2Kc2gH7ksZPMmQWPBoKxsYR6ZN1TVWIi8U_LcyPrpTaITreMaGymIfQ

We are coming up on 100,000 patients in Nancy's Nook with 1100 a week or so coming in now. They have failed all gynecology has to offer except expert excision of their disease. Most have been abused with denial of their symptoms, or told they are neurotic or do not have endometriosis. When surgeons and teams are doing good work and getting good outcomes long term, it is easy to see they may not appreciate the true nature of the crisis. Millions of patients languish in peritoneal quality pain, dismissed, inadequately treated. The state of the art is in a very sorry state.

It is way past time for standards of care, treatment and training centers, limited treatment of patients with endometriosis by untrained providers, and time for vetted skills for certifications before allowing gynecologists or others to operate on endometriosis patients. We are destroying lives through lack of skill, inadequate approaches, denial of the patients' realities. Pockets of excellence cannot resolve this mess, leadership is needed among the global GYN community leaders/organizations. The question becomes how long can they stonewall against the need for standards of care, expert training centers, outcome measurement with multidisciplinary teams to address all pelvic pain generators? Who wins with stonewalling and gaslighting? Not the patients.

Outcomes with expert excision:

www.endopaedia.info David Redwine's published research encapsulated in this website

https://journals.sagepub.com/doi/abs/10.5301/je.5000264?journalCode=peva

https://www.ncbi.nlm.nih.gov/pubmed/20129331

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4861171/?fbclid=IwAR3elkdB0nsDFb9pk9LiR7iArgY-B82G52h7VxbABVFHudNfOXLBzxsZPJ8

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3662751/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6112593/