NPAN supports PRI?
Jenny Birdsey, Director of NPAN, says that 10% of the ebook sales is "pledged" to progesterone research. Could she mean PRI, the Progesterone Research Institute, that Dr. John Lee runs? Does Dr. Lee get funded by money from the PRI, in essence making money from sales of the ebook? What about creams? You can write the PRI and legally ask for their last 3 years of tax returns.
Concerns on OBGYN.NET allows this product to be directly and indirectly promoted 
on their forums. Emails to on enforcement of the advertised rules does not appear 
to happen on a consistent or all across the board manner, and any private requests have met with
threats of action, name calling, and other negative comments. The website does state that 
its purpose is to give "accurate" information on health issues. Please investigate with 
your own medical doctor or similar type of medically educated professional, regarding 
information received there. Whether or not this has anything to do with a company 
deals with that produces 'a fine cream', I don't know. has known that this product is questionable. However, since the rules on the site state
that people may have differing opinions, and that it is for information, why does it appear that
I am unable to post to Why do they not allow you to see the information below? 

After almost a year of not posting to, and seeing that they did nothing to stop 
the touting of this product for that time, I posted a response on, if it is still
there its on November 23rd on the endometriosis forum. I received an email from {} saying
the problem was taken care of. However, when I responded back that nothing appeared to have been
done (November 25th) I got the following:

This Message was undeliverable due to the following reason:

Each of the following recipients was rejected by a remote mail server. The reasons given by the 
server are included to help you determine why each recipient was rejected.

    Reason:    5.7.1 ... [] Access denied by  
    Please see for more information.

Please reply to
if you feel this message to be in error.

Interesting wouldn't you say? Getting spam blocked for sending you to a site that said the product
violated FDA rules and the proof of it. Why does not want that???

I also note that one doctor appears to support the use of this product, 
and also has recommended gingko bilboa's use. I would be  
interested to know what the background/circumstances are of those this doctor stated concerning the
"several have supported its value for increasing sex drive". I wonder if this is in line with Dr. 
Marchbeins' 'Guidelines for posting to the WOMENS-HEALTH forum' regarding 'basic, accurate and timely medical
information' that is posted every day.


Progesterone creams research data and other CAM related material

An investigation into the legality and science behind progesterone creams
led to quite startling discoveries. The testimonials were all extremely
positive. My effort to distinguish fact from fiction led me to question the
legality of the creams, the research behind them, and the extent to which
they are promoted for money. You would want to especially question I. Selling 
the product/marketing scheme, #2. 

  I. Natural Progesterone
     A. Is it legal? 
        1. FDA references and warning letters
        2. FDA descriptions of dietary supplements
        3. FDA letters to companies on progesterone cremes
     B. MD/RN comments on progesterone creams
     C. Medline evidence
        1. Anti progesterones in endometriosis, fibroid treatment
        2. 'Progesterone cream' search and results
        3. 'Lee JR' search and results, mostly on osteoporosis
     D. Compounding pharmacies 
     E. Questionable tactics of progesterone cream proponents
     F. The claims
        1. One website reviewed
        2. Email list claims and testimonials
        3. Bias from those testifying for this product
        4. Why doesn't it work for everyone? 
     G. Claim rebuttals and responses, side effects
     H. Selling the product/marketing schemes?
     I. Further information needed: can you help?
     J. Wild yam creams
        1. Do they work?
        2. Doctor comments
     K. Progesterone supplementation during pregnancy
     A. Spotting it
        1. Using the 'fear' factor to sell
        2. Profit motive and related complaints
     B. Who is vulnerable to it?
        1. Resources
        2. "The Deadly Perils of Rejected Knowledge" by Thomas 
           R. DeGregori, PhD 
     C. Cases where natural and/or non scientific studied 
        substances caused problems
     D. General information on many different questionable health 
        1. Links
        2. Books
     E. Private email comments
     F. Debating it
     F. Errata
     G. Doctor attitudes and manners and patient effects:

III. Scientific methods: resources for understanding testing methods
IV.  Questions
V.   Summary 

Last update: Sept 11, 2012

I. Natural progesterone

A. Is it legal?

   1. Apparently not. See FDA references and warning letters
      a) Cyber letters 
         issued from CFSAN are to Internet Website 
         Operators promoting dietary supplement products that 
         claim to diagnose, mitigate, treat, cure, or prevent a 
         specific disease or class of diseases.  
      b) FDA
         In addition, only products that are intended for ingestion 
         may be lawfully marketed as dietary supplements. Topical products 
         and products intended to enter into the body directly through the 
         skin or mucosal tissues, such as transdermal or sublingual products, 
         are not dietary supplements. For these products, both disease and 
         structure/function claims may cause them to be new drugs.
      d) 1
      e) 2
      f) 3
      g) 4
      h) 5

   2. FDA descriptions on dietary supplements
      a) 1
      b) Dietary Supplements
      c) US FDA Food Safety & Applied Nutrition Dietary Supplements
      d) 2 
      e) 3 
      f) Conventional Foods and Dietary Supplements Claims list

B. MD/RN comments on progesterone creams and related theories
   1. Binds like valium 
   2. Binds like valium 2 
   3. Placebos and success 
   4. No such thing as a non side effect drug 
   5. Background facts 
   6. No scientific trials 
   7. Not for untested products 
   8. May not contain what's advertised 
   9. Dr Lee's work not reproducible
  10. Dr Lee's work not scientifically proven 
  11. Not effective 
  12. Won't result in expected outcome 
  13. 3 
  14. Not effective 
  15. Bad information
  16. Is "bunk"
  17. Unknown absorption rate
  18. 4
  19. is "quackery"
  20. Skin is a barrier to absorption
  21. Info gets distorted
  22. Who will the patient sue?
  23. Don't know what they're getting
  24. Pharmacist found no progesterone in product
  25. Views on synthetics
  26. Tried it and it didn't work
  27. Data not published in science journals
  28. Binds like Valium
  29. No studies showing it works
  30. is a placebo
  31. Skin is barrier to absorption
  32. What is natural?
  33. FAQ
  34. "underpowered" and may not do what you think
35. prolonged cycle
C. Medline evidence: review the sources 1. Anti progesterone treatment in endometriosis, fibroid treatment a. (Dr. Michael Kettel's work) Dr. Michael Kettle and others have found Mifepristone (an anti-progesterone) to help with endometriosis. With this being true in scientific studies, then how can endometriosis be helped by more progesterone? Do a search on 'endometriosis mifepristone' or 'endometriosis ru486' or 'endometriosis ru-486' at Pubmed). b. A similar search was made on Pubmed in regards to the search criteria 'Progesterone cream' on Sept. 15, 2002. None of the studies led to any valid conclusion that it was effective. The salivary tests weren't of any value by these. Dr. Lee published his side of the story, but doctors questioned whether or not the product should be used at all due to "inadequate" dosage, "unsubstantiated characteristics", "unsupported anecdotes", lack of ethics board review or patient informed consent. (*John C Stevenson, David W Purdie, *Rosen Laboratories of the Wynn Institute, Imperial College School of Medicine, Centre for Metabolic Bone Disease, Hull Royal Infirmary, University of Hull, Kingston upon Hull) c. Another doctor (Cooper et all) stated ""We find it difficult to envisage how progesterone could bind to red blood cells". d. Dr. Lee now proposes "actual clinical studies . . ." Lee's original report on Pro-Gest and the reversal of osteoporosis was a hypothesis". "We remain very concerned about the clinical use of Pro-Gest because of the absence of scientifically valid supportive studies on endometrial protection and bone conservation. Prescription should follow scientific evaluation--not the reverse." Cooper A, Spencer C, Whitehead MI, Ross D, Barnard GJR, Collins WP. Systemic absorption of progesterone from Progest cream in postmenopausal women. Lancet 1998; 351: 1255­56. [PubMed] and Dollbaum CM, Duwe GF. Absorption of progesterone after topical applications: serum and saliva levels. Presented at the 7th Annual Meeting of the American Menopause Society, 1997. 2. The Lancet, Volume 354, Number 9188, 23 October 1999, Research Letters, Micronised transdermal progesterone and endometrial response by Barry G Wren, Kathy McFarland, Lyndall Edwards 3. Transdermal progesterone and its effects 4. Menopause 2003; 10(1):13-18 Barry G. Wren, AM, MD, MBBS, MHPED, FRANZCOG, FRCOG; Susan M. Champion, SRN, MCN, (NSW); Karen Willetts, BSc, DPhil; Robert Zoa Manga, MBBS, MPH, MHSM; John A. Eden, MBBS, MD, MRCOG, FRANZCOG, CREI The conclusion is that the use of the transdermal route to administer progesterone at 32 mg daily does not seem to allow sufficient hormone to enter the body to achieve a biological effect on lipid levels, bone mineral metabolic markers, vasomotor symptoms, or moods. This work was supported by a grant provided by Michael Buckley of Lawley Pharmaceuticals, Western Australia, manufacturers of Pro-Feme progesterone cream. 5. Sequential transdermal progesterone administered with continuous transdermal oestrogen was insufficient to increase circulating blood progesterone concentrations or induce a secretory response in proliferating endometrium. Sydney Menopause Centre, Royal Hospital for Women, Randwick, NSW 2021, Australia (Barry G Wren MD, K McFarland BHSc, L Edwards FRCPA) 6. The Lancet Volume 350, Number 9070, 05 July 1997, "Keep taking the tablets for HRT" Could natural progesterone cream replace conventional HRT? Alison Cooper (King's College Hospital, London, UK) at the British Menopause Society conference (Birmingham, UK; June 26-28). Many claims have been made for Progest cream, which is derived from the wild Mexican yam. According to its proponents, indications include treatment of menopausal symptoms, osteoporosis, and premenstrual syndrome. The King's College Hospital team did a prospective, double-blind, randomised placebo-controlled cross-over study of the cream, using pharmacokinetic data as the endpoint. Postmenopausal women applied one teaspoon of cream (twice the recommended amount) to the arm or thigh, morning and night for 10 days. The average increment in plasma progesterone was 3 nmol/L. "Although this rise was statistically significant, it is difficult to see how such a low blood level could have any biological effect", said Cooper. "We would caution women against using this product until more scientifically rigorous data become available." 7. Natural Progesterone for Osteoporosis Prevention 8. 'Lee JR' search and results on Pubmed, mostly on osteoporosis, Sept. 16, 2002 Out of the 8 pages with 146 entries, I found 2 entries that I could associate with Dr. John Lee. One was his opinion on 'Use of Pro-Gest cream in postmenopausal women' in the Lancet, 1998 Sep 12;352(9131):905; discussion 906. The second was an erratum in Medical Hypothesis in 1991 Oct;36(2):178. None of his studies have been published in any accepted medical journal. Note that the 1994 Calcium, estrogen, and progestin in the treatment of osteoporosis study stated that "Progesterone, often given with estrogen to prevent endometrial carcinoma, may itself have a trophic influence on bone." 9. A study in England found ( progesterone cream failed to stop osteoporosis. D. Compounding pharmacies Pharmacists that compound their own versions of approved drugs do not always create the correct dosage, according to a study by the United States (FDA) reported September 21st at the 31st Annual Meeting of the American College of Clinical Pharmacology (ACCP). The Misuse of Compounding By Pharmacists by Bruce A. Bouts, RPh, MD, FACP. E. Tactics of progesterone cream proponents One of the most common tricks is for someone to ask about a treatment. Then the shill posts their answer. Shills are used in gambling halls. They play with house money to generate activity or enthusiasm at the tables. The advice offered by these shills is not to be trusted. They are used to plant questions that the speaker has predetermined answers for. 1. Personal experience testimonials only are used to support this position. Subjective vs. objective means of proof something 'works': 1 2 3 4 2. Distruct of allopathic, science based physicians: Note that you are "attacking" them when you question their beliefs without science evidence PLEASE REFERENCE 1 2 4 5 6 7 3. Higher dosages: getting you to buy more of the product (who does that benefit? Those who produce the product, and all the middlemen). 1 2 3 4. Promote other drugs problems, w/o supporting their own, so you distrust/fear regular medications: 2 5. Promotion of inaccurate testing, or never tested while proven testing is discounted: 1 2 3 4 6. Discrediting the messenger(s) so that the message that progesterone creams are possibly illegal and ineffective doesn't get out. The other option is to do whatever is possible to get legitimate medical information off of people who are willing to take a stand on questionable health products: A. The FDA. From what I saw of here and here and the related comments, my impression is that people don't understand what the FDA is. 1. 1 2. 2 3. 3 4. 4 5. 5 B. Myself (along with the other evidence): 1. 1 2. 2 3. 3 4. 4 5. 5 6. 6 F. The claims 1. One website reviewed As of Jan. 13, 2003 I removed this from my site. Seems the website in question has removed it and is now selling another questionable product. As for Jan. 21, 2003, I found another site: Emerita Pro-Gest® Cream - 2 oz. The claims are that its been "praised by professionals and recommended by top physicians." Like who? Ingredients are usually listed in order of amounts in the product. For example, if ingredient A is 20% of the product its listed before ingredient B at 19% of the product. In this case, aloe vera gel is the ingredient listed first. Progesterone is the 9th on the list. There is nothing to say where the progesterone is made from. The only disclaimers are: *All information presented throughout this web site is for educational purposes only; statements about products and health conditions have not been evaluated by the U.S. Food & Drug Administration." This is NOT what the FDA requires. 2. Email list claims and testimonials a. 1 b. 2 c. 4 d. 5 e. 6 f. 7 g. 8 h. 10 i. 11 j. 12 k. 13 l. 14 m. 15 n. 16 o. 17 p. 18 Note anonymous postings, which can be created by anyone wanting to post to the board. You'll see much of the progesterone cream pro side advertising as anonymous, usually without a name or anything else. 3. Distrust of medicine, definition of malpractice G. Claim rebuttals and responses, side effects, including info on the 'placebo effect'. a. Someone who tried the cream ** Good questions b. 2 c. 5 d. 6 e. 7 f. 8 g. 9 h. 10 i. 11 j. 12 k. 13 l. 14 m. 15 n. 16 o. 17 p. 18 q. Why bogus therapies seem to work r. Spontaneous remission and the placebo effect s. 22 t. 23 u. 26 v. "Testimonials abound supporting progesterone cream. However, claims about the magic of progesterone still lack valid scientific support." w. "In fact, one study of a "very popular cream that you rub over your belly ... found that it didn't work at all -- that women are just wasting their money," Nachtigall adds. "In fact, the man who markets that cream writes his own reviews and publishes these brochures that are handed out in health food stores, and women read them and believe them. But it's honestly useless. And that in itself is "probably good because if it was active, it would probably do a lot of harm." H. Selling the product/marketing schemes? 1. 1 2. NPAV Since we have no way of knowing who is a member and who isn't, wouldn't financial interest be a reason to promote these? 3. 3 4. NPAN 5. 5 6. Marketing to The Heart The Perfect Cure for Quackery 7. A private email from one of's administration, admitting they deal with a company who produces 'a fine cream'. 8. 8
I. Further information needed for verification: can you help with reliable sources? 1. That Dr. John Lee owned Avion Labs, a testing lab to measure progesterone levels, before being sold to an 'ally'. 2. That Dr. John Lee sold or has recommended specific creams in which he received compensation for in the 1990's or earlier. 3. That Dr. John Lee recommended at one time testing and getting progesterone from Avion Labs, which he owned. 4. That Dr. John Lee makes money from Endau creams, sent to the Progesterone Research Institute. PRI
J. Wild yam creams 1. Do they work? a. 1 b. 2 2. Doctor comments a. 1 b. 2 K. Progesterone supplementation during pregnancy. Not only has this not been proven to be safe in acceptable scientific studies, but its touted by non medical professionals. Are you willing to risk it? 1. 1 2. 2 II. CAM links: what to watch out for: a. 1 b. 2 c. 1 d. 2 e. From the NCCAM website: Funding Strategy: Fiscal Year 2001, Overview NCCAM's Fiscal Year 2001 appropriation from Congress is approximately $89 million. This figure reflects a 29% increase over the Fiscal Year 2000 budget. Research Project Grants: In Fiscal Year 2001, the Research Project Grant (RPG) portion of the NCCAM budget is expanding to 36% of the total budget. RPGs accounted for 24% of the Fiscal Year 1999 budget. The RPG line item is expanding relative to other segments of the budget in light of more than a 12-fold growth in grant applications received since Fiscal Year 1999. Most of this money is targeted to investigator-initiated research. f. Physician Exec 1998 Nov-Dec;24(6):6-14, Spending for complementary and alternative medicine (CAM) nationwide has been estimated at up to $14 billion a year. g. J Nurse Midwifery 1998 May-Jun;43(3):224-34, Women's use of complementary and alternative therapies in reproductive health care., its also estimated in the billions. h. 1 i. "The Deadly Perils of Rejected Knowledge" by Thomas R. DeGregori, PhD, healthfraud email list, Sept. 13, 2002. j. k. Cagey Consumer l. Herbal Watch m. 1 n. 2 o. Psychologists Educating Students to Think Skeptically (PESTS) p. 4 q. Fraud & Quackery Internet Resources r. Miracle Cures and Healthcare Hoaxes s. The Quack-Files Homeopathy Links t. The Quack-Files Anti-Quackery Resources u. homeopathy v. CQ - Canadian Quackery Watch w. Dietfraud HQ - Cellasene takes it all away x. Alternative Medicine A Skeptical Look Scientific Methods y. Statement of Timothy Gorski, MD z. Broadsheet 1. Alternative Medicine A Skeptical Look 10 ways to avoid being quacked 2. >Alternative Medicine A Skeptical Look Placebo effect 3. Health Fraud - Medscout (sm) 4. Herbal Remedies Adverse Effects and Drug Interactions 5. >FDA-CFSAN Illnesses and Injuries Associated With the Use of Selected Dietary Supplements 6. >Adverse reactions to dietary supplements under investigation by FDA 7. Herbals.Swh 8. Dietary Supplements Require Better Safety Controls in the US 2. Books Evidence-Based Herbal Medicine, by Dr. Michael Rotblatt (October, 2001). Dr. Rotblatt is an internist and assistant clinical professor at UCLA. E. Debating it Reprinted with permission: From: Dr. David W. Ramey, Sent: Thursday, August 08, 2002 8:34 AM Subject: Re: "So long and thanks for all the fish..." One of the debate tactics that I've seen over the years is to respond to questions about failed logic and lack of evidence with the response that the person doing the questioning is mean. Obviously, this sort of response totally begs the question and it's not likely to be true. So, while, it is important to be civil, it's not necessary to just roll over, either. Obviously, there's a fine line. Still, in my view, one of the problems between science and journalism is that science is not and does not strive to be fair or "balanced." In science, all ideas are *not* treated equally. Only those that have satisfied the test of experiment or can be tested by experiment have any currency. Beautiful ideas, elegant ideas and even sacrosanct notions from ancient times are not immune from rejection based on experimental data. Science is always open to new ideas, but open-mindedness does not mean that all ideas are equally good. Debate about such ideas is rather ruthless because it relies on data and doesn't really care much about people's feelings. But it's also possible to have vigorous debates and to disagree, but still get along, at least if everyone is willing to play by the rules. So, in conclusion, to present "both sides" of a debate about "alternative" medicine as being equal simply because people have different ideas is not really balanced. But to drown out legitimate questions under the aegis of it being impolite is not a good thing, either. David Ramey, DVM F. Errata Panel Addresses Financial Conflicts in Clinical Trials Progesterone FDA Revises Rules on Promotion of Health Benefits of Foods FDA Designate to Certify Supplements
G. Doctor attitudes and manners and patient effects: I spent a couple months on lists that debunked non science based health products and services. However, when it came to the effects that doctors have on their patients by their attitudes, I got a lot of negative press. My feeling is that the more doctors and related health professionals don't give their patients a caring hand, it pushes people away from science. It could make them more susceptible to other methods that aren't science based, in a position to be taken advantage of. I collected a couple of links for things doctors can do to help: Got Two Minutes Good Communication Cuts Risk I created a list of items that patients are looking at and from doctors want doctor to provide reasoning for decision making, basic information want to know doctors are concerned for patients' best interests want to know doctors are familiar and up to date with research ok to not be familiar if willing to find information from other experts want to know doctors won't pass themselves off as experts when they aren't attitude turn off, giving appearance of patients as dumb/inferior, not listening reading material important for patient empowerment, best care faith in physician is an intregral part if patient is included in decision making process, more likely to follow treatment want doctors to understand patients are willing to listen/be reasonable don't want doctors to give military type orders bad experiences can influence how you feel about docs, medicine and science not allowing choice between similar medications a big problem partnership with doctor was highly rated amongst all respondents doctors may bear legal/$ costs, but patients' living with consequences most important want to know docs don't prescribe due to pharmaceutical concerns, only medical science background not needed to get an idea of what research is going on PCOS: want to be more than just trying to get pregnant/not trying to get pregnant III. Scientific methods: resources for understanding testing methods and related links a. 1 b. 2 c. 3 d. 4 e. 5 f. 6 g. 7 h. 8 i. 9 j. 10 k. Some Notes on the Nature of Science l. Marketing to The Heart m. Diet Supplement hearings n. CDRH Consumer Information
o. Consumer Advice
p. Buying On Line
q. How do you recognize quackery
s. The Quack-Files Anti-Quackery Resources
t. The Quack-Files A Consumer Advocate's Dilemma
u. Advocates advise patients to ask questions, do their homework
v. Science Fiction by Chris Mooney
w. August 2, 2002, NUTRITION NEWS FOCUS, Today's Topic: Failure Number 1,283, has more facts: "a minimum of one-third of nutritional supplements do not supply what is on the label. A recent analysis of supplements promoted for prostate health in Canada comes to a similar conclusion." The testing was on several OTC products, including vitamins and saw palmetto. You can find the study in, The Journal of Urology. x. Wyeth
y. VCU library
z. Endolynx
l. Complementary And Alternative Medicine from WebMD Scientific American® Medicine, Adrian S. Dobs, MD, MHS; Bimal H. Ashar, MD, and SAMED.
IV. Questions to ask yourself: 1. Why are most posts comparative to Provera, versus Prometrium, a plant based proven progesterone? Why isn't Prometrium, a proven plant based FDA approved medication promoted as an alternative? 2. If we don't know the dosage level on progesterone creams, how can we not overdose and not ovulate? 3. What exactly is a 'physiologic dose'? 4. Isn't there a difference between 'benefits' and 'effectiveness'. Placebos have no 'benefits'. Doesn't mean they are 'effective' in treating a disease or problem. 5. Proof of Prometrium/liver overdose? 6. Progesterone is a precursor to a lot of other hormones. What does it become once in the body, what other hormones? 7. Does Dr. Lee still have an interest in ProGest? 1 8. Progesterone cream has estrogenic properties. Does Dr. Lee say this in his book? 1 9. Where is the recognition when the scientific community tries to clean up problems? Panel Addresses Financial Conflicts in Clinical Trials One in four hospital prescribing errors potentially serious
10. Where does the 'natural progesterone' in these creams comes from? Isn't it manufactured, and how does that process change the progesterone? What is the effect of the fillers on the body? Coincidence or not? Recently several email groups have been advertised. Do these sites sell products or links to products to cure/treat/alleviate diseases or symptoms? 1) Endonatural 2) Happy Hormones Arbonne comes up a lot on web searches for 'progesterone cream' as the search criteria. They hadn't been mentioned before, until this post on the PCOS forum that I made in rebuttal to it: Then on the endometriosis list at the same site, an article was mentioned regarding this same company, again, which hasn't been listed before: I asked about it, referring to page'. I also asked for the full citation, although it was never posted. The link was to: Then another posting showed up on the PCOS list the next day: Note the the Endonatural group sells items (some at a discount) to endometriosis sufferers. V. Summary Are natural progesterones legal? Apparently not. Not only do most not have disclaimers, but products that are for topical application (through the skin) or sublingual products, are not dietary supplements. Medical authorities have listed a number of reasons why they do not prescribe them, as double blind, placebo comparative studies have not been done for proven efficacy. Nor has the theories behind the major proponent of progesterone creams, the 'estrogen dominance' theory, been proven. Compounding pharmacies used to make creams have problems. Wild yam cream is proven to not work. Should you take one of these products, and have a problem with them, please contact the FDA to complain. FDA Complaint FDA Overview