Oprah and Somers misrepresenting self hormone therapy

[bundschuh]

Bioidenticals are tailored for each woman's hormone situation, my blood was tested 4 times over 4 weeks to figure out what hormones I needed and what dosages and when. I see my doctor every 3 months for refills, he does not prescribe 1 year of dosages.

Big pharm generally mixes estrodial and progestins (not estrogen and progesterone) together whether you need estrogen or not.

The studies do show postmenopausal women who take big pharmhormones for 5 years or longer (combo estrodial and progestins) have a higher chance of cancer. When they stop, the higher chance of cancer stops immediately.

For me, the bioidentical hormones have been a godsend.

 

[hiitdogs]

The agency has nothing to gain by "keeping" products from consumers, but does have a mission to "protect and promote the public health."

Just sayin!
Liz

The FDA is a far cry from their original mission to protect and promote public health, the mission these days seems to be to protect and promote the profits of the pharmaceutical industry. The agency may not have much to gain by keeping products from consumers but the ties of many employees of the agency to the pharmaceutical industry are much to close for comfort.

This video is very long but quite interesting.

http://video.google.com/videoplay?docid=-2502546838698762400

Certain products are cleverly marketed so that they don't treat the disease or condition (for example, "Enzyte for natural male enhancement" and not erectile dysfunction).

As if whatever the pharmaceutical industry cleverly markets to the general public by showing healthy people doing Thai Chi, riding their bikes, etc. ever really treats the disease or condition, at best it treats the symptoms. Not only does it not always treat the condition, what about the side effects.

Where was the FDA to protect the consumer with Vioxx or when prescription psychopharmaca killed teenagers, etc. Just because the FDA approves a drug doesn't mean that it is safe.

 

[hiitdogs]

I wish Oprah would have asked Suzanne about her breast cancer and how it related to BHRT.

Not all breast cancer tumors are receptive to estrogen or progesterone. About 30% of women have ER-/PR- (estrogen/progesterone receptors negative) or a combination. Not all breast cancers are caused by hormones and not in all breast cancers tumor growth is promoted by hormones. I don't know if Suzanne Somers had ER+, I am assuming she did because I read she also refused Tamoxifen which usually is recommended/given with estrogen positive tumors.

Suzanne Somers was diagnosed with breast cancer in spring of 2001, now it's 8 years later. Apparently her breast cancer hasn't returned in 8 years, looks like her BHRT did not effect her breast cancer so far.

 

[rjroubi]

Not all breast cancer tumors are receptive to estrogen or progesterone. About 30% of women have ER-/PR- (estrogen/progesterone receptors negative) or a combination. Not all breast cancers are caused by hormones and not in all breast cancers tumor growth is promoted by hormones. I don't know if Suzanne Somers had ER+, I am assuming she did because I read she also refused Tamoxifen which usually is recommended/given with estrogen positive tumors.

Suzanne Somers was diagnosed with breast cancer in spring of 2001, now it's 8 years later. Apparently her breast cancer hasn't returned in 8 years, looks like her BHRT did not effect her breast cancer so far.

As quoted from the Newsweek article provided by the OP
http://www.newsweek.com/id/183842:

"Nor did Winfrey ask Somers about her own history of breast cancer—Somers was diagnosed with the disease after she started taking her estrogen supplements—or more recent precancerous changes in Somer's uterus that led to her hysterectomy. (Privacy wasn't an issue; Somers has written extensively about both incidents in her books.) Winfrey also didn't question Somers about her decision to continue hormone supplementation after the cancer diagnoses or her latest cancer-fighting theory: that older women should "restore" their hormones to the levels they had in their 30s and start having periods again, because then they'd be more like younger women who get less cancer. That upside-down logic puts Somers at odds with just about every oncologist in the country."

Women should make truly informed choices with their physician....they shouldn't be influenced by marketing schemes...the word "bio-identical" ...or celebrities who swear they are the fountain of youth. Suzanne Somers should keep to her thighmaster...

 

[hiitdogs]

I don't know where the article comes up with the claim that Somers was diagnosed with breast cancer after she started taking "estrogen". I couldn't find anything on that but I haven't read her book(s). The "pre-cancerous" cells which led to the removal of her uterus was uterine bleeding with an elective hysterectomy. This had nothing to do with her breast cancer. In fact, uterine cancer is one of the side effects of the estrogen inhibitor Tamoxifen that is prescribed to breast cancer patients in order to block estrogens in ER positive breast cancers.

Not that I think that Suzanne Somers is an expert on much more than Thighmasters and certainly not someone who is a medical expert but it is absolutely her right to write a book about her personal experience. She has said several times on her breast cancer treatment and in respect to BHRT that she does not advocate it for anyone else but herself. I don't think anyone in their right mind should blindly follow or buy into anything a celebrity or even a medical professional says without doing their own research or get a second opinion.

I just finding really curious as to how all those experts are ripping into bioidentical hormones. I am sure it has nothing to do with the fact that drug companies can’t patent a bioidentical structure, so they invent synthetic hormones that are patentable and profitable, hiring their "experts" to slam everything else.

Women should make truly informed choices with their physician....they shouldn't be influenced by marketing schemes...the word "bio-identical" ...or celebrities who swear they are the fountain of youth. Suzanne Somers should keep to her thighmaster...

Hmmh, interesting but it is okay for the pharmaceutical industry with their "marketing schemes" to slam us with tv commercials, magazine ads, etc. using celebrities like Lance Armstrong, Sally Fields, etc. How is that any ?different?

 

[rjroubi]

I just finding really curious as to how all those experts are ripping into bioidentical hormones. I am sure it has nothing to do with the fact that drug companies can’t patent a bioidentical structure, so they invent synthetic hormones that are patentable and profitable, hiring their "experts" to slam everything

This is what I mean. People don't understand that the word Bio-identical is a marketing term and misleading:

From the FDA:

"The term “bio-identical” has no defined meaning in any medical or conventional dictionary, and FDA does not recognize the term. Even different medical groups define the term differently. The Endocrine Society, for example, defines “bio-identical” hormones as “compounds that have the exact same chemical and molecular structure as hormones that are produced in the human body,” while the American College of Obstetricians and Gynecologists (ACOG) defines “bio-identical” hormones as “plant-derived hormones that are biochemically similar or identical to those produced by the ovary or body.”

Many compounding pharmacies use “Bio-identical” as a marketing term to imply that drugs are natural, or have effects identical to those from hormones made by the body. FDA is not aware of credible scientific evidence to support these claims. Compounded products that have identical chemical structures to synthetic hormones can be expected to have the same benefits—and risks— associated with FDA-approved hormone therapy.

Some pharmacy compounders claim that their compounded “BHRT” drugs are a “natural” alternative to FDA-approved drugs, because the compounded hormones are purportedly identical to the hormones produced in the body. These pharmacies may also claim that their “natural” compounded drugs are safer and more effective than FDA-approved menopausal hormone therapy drugs. FDA is not aware of any credible scientific evidence supporting these claims. Nor is FDA aware of sound evidence showing that the side effects and risks of compounded "BHRT" drugs that use estrogen and progesterone as active ingredients are different than those of similarly formulated FDA-approved menopausal hormone therapy drugs. Because many claims regarding the safety, efficacy, and superiority of compounded “BHRT” drugs have not been proven, FDA is concerned that these claims mislead patients and practitioners. Compounded products that have identical chemical structures to synthetic hormones can be expected to have the same benefits—and risks— associated with FDA-approved hormone therapy."


There are already so called "Bio-identical" hormones approved by the FDA on the market....that have at least been studied for saftey and efficacy. People don't have to go to compounding pharmacies to get them, but if they want to that's fine. Be really informed of the risks.....and not mislead by the words.

I also agree, it should not be okay for the pharmaceutical industry to slam us with marketing schemes.

 

[teddy16410]

I also find it offensive that when people disagree about mainstream medicine (actually - mainstream anything) that we are being DUPED or MISLEAD....

Advertising is all about hype...I don't see non FDA approved bio-identicals showing commercials ad nauseum about how my life will be better if I use their product

Breast Cancer occurs in millions of women who have never taken a hormone in their life. If you'd like the name of my 12 immediate female relatives that have/are fighting breast cancer & have never so much as taken a birth control pill - PM me!

I am not misled, misunderstanding, misdirected nor am I being duped. I am a responsible 46 year old woman that has researched and followed the HRT industry over the last 25 years. I have made an informed decision about my medical care, I am thrilled with my results, I think I am to be respected & commended for doing so & not chastised.

I do not judge, look down upon, try to alter someones mind - based on my beliefs & my personal research & history and I'd like the same respect from those on the other side of the fence.

Nothing...absolutely nothing that is considered conventional medicine today was thought of this way 20 years before its time. If new, different, untested, unchartered waters are not consistently embraced we stagnate- we never find cures - we never move forward.

 

[hiitdogs]

FDA is concerned that these claims mislead patients and practitioners.

Very funny! Maybe the FDA should be concerned about the misleading of the public by the pharmaceutical industry, and the FDA should be even more concerned about having lost sight of their mission of protecting the public instead of the Food and Drug industries.

I don't believe anything that comes out of the FDA! Their whole approval process relies almost solely on what they are told by the drug companies. Clinical trials that are required for the approval process and ongoing monitoring are over 70 % carried out by the drug companies themselves, about 20 to 25 % are sponsored by the drug companies and 5 to 10 % are independently studied. Phase I, II and III clinical trials are done and submitted to the FDA to approve the drug. Phase IV clinical trials are after the drug is already approved.

People need to know that the pharmaceutical industries don't have to use any of the unfavorable outcomes of clinical trials to submit to the FDA. They are allowed to selectively pick and chose which clinical trials to use and not report/disclose the others. How is that for complete information?

After the drug is approved doctors and health practicioners have to the report side effects to the drug companies - not the FDA. The drug companies keep track and report (or don't) to the FDA.

Safety and concern about consumers? Yeah, right! It's about money and it is not uncommon that FDA employees who have been cooperative get lucrative jobs in the pharmaceutical industries.

The FDA can write whatever they want on their website. It is absolutely meaningless. They are doing a fine job of protecting the industries that fund their very existence. But they sure don't protect the consumer and it makes me sick to my stomach people believe because the FDA approved a drug or treatment, it is "safe".

 

[rjroubi]

Very funny! Maybe the FDA should be concerned about the misleading of the public by the pharmaceutical industry, and the FDA should be even more concerned about having lost sight of their mission of protecting the public instead of the Food and Drug industries.

I don't believe anything that comes out of the FDA! Their whole approval process relies almost solely on what they are told by the drug companies. Clinical trials that are required for the approval process and ongoing monitoring are over 70 % carried out by the drug companies themselves, about 20 to 25 % are sponsored by the drug companies and 5 to 10 % are independently studied. Phase I, II and III clinical trials are done and submitted to the FDA to approve the drug. Phase IV clinical trials are after the drug is already approved.

People need to know that the pharmaceutical industries don't have to use any of the unfavorable outcomes of clinical trials to submit to the FDA. They are allowed to selectively pick and chose which clinical trials to use and not the report the other. How is that for complete information?

After the drug is approved doctors and health practicioners have to the report side effects to the drug companies - not the FDA. The drug companies keep track and report (or don't) to the FDA.

Safety and concern about consumers? Yeah, right! It's about money and it is not uncommon that FDA employees who have been cooperative get lucrative jobs in the pharmaceutical industries.

The FDA can write whatever they want on their website. It is absolutely meaningless. They are doing a fine job of protecting the industries that fund their very existence. But they sure don't protect the consumer and it makes me sick to my stomach people believe because the FDA approved a drug or treatment, it is "safe".

Ah, but the FDA has a heck of a lot more crediblility than Suzanne Somers....and let's not ever forget Thalidomide. Who protected us then? It certainly wasn't the general public who wanted the drug introduced into this country. Oh, yes, we would have had a lot of babies born in this country with missing limbs. Remember? It was the FDA who wouldn't approve it.

I agree with you on many points.....there is a lot of corruption (read "Overdosed America" by John Abramson) on all levels. I also believe their is a lot of money to be made in the bio-identical hormone industry....they are certainly not immune. I just feel that people in general should be fully aware of the risks and not hoodwinked. Biased reporting by the television industry on any level....pharmaceutical or otherwised (ie. Oprah) simply shouldn't be allowed.

 

[teddy16410]

I just feel that people in general should be fully aware of the risks and not hoodwinked. Biased reporting by the television industry on any level....pharmaceutical or otherwised (ie. Oprah) simply shouldn't be allowed.

Robin:
I still am not clear why you feel that those who choose alternatives are being " hoodwinked". Isnt it the right of every American to know all the options, all the points of view & then have the responsibility to investigate & then the right to choose?

As far as the statement: "Biased reporting by the television industry on any level....pharmaceutical or otherwised (ie. Oprah) simply shouldn't be allowed"....

I'm sorry that feels like censorship to me - I do not want ANY government agency or advertising company dictating the information I can listen to. Because I choose diffferently than you I am not hoodwinked. Who's to say that those going down the path of FDA approved only items arent being hoodwinked?

 

[jackie7]

Sorry, but I don't have much faith in the FDA. I think women have to make informed choices on their own.

My dad was an MD but never believed in any alternative meds. My aunt had arthritis and finally found relief in acupuncture; medical doctors could not help.

I believe these women using bioidenticals are blazing a path. They are researching for future generations. Who knowe what the outcome will be, but they should be respected for making their informed decisions.

 

[hiitdogs]

Ah, but the FDA has a heck of a lot more crediblility than Suzanne Somers....and let's not ever forget Thalidomide.

That's where we disagree, I don't think the FDA has any credibility.

What about Thalidomide? That was in 1960, back then the FDA was not only operating much differently, it actually had some credibility. Thalidomide caused birth defects of missing limbs and effected about 10,000 children in Europe and Africa. Do you want to talk about how many people were killed or their health destroyed by the FDA-approved drug Vioxx? Up to 150,000 heart attacks can be attributed to Vioxx, 30 to 40 % of them were fatal, that's about 50,000 deaths that could have been and should have been avoided!

There are drugs approved by the FDA that cause heart toxicity, when asked, some doctors will just flat out deny it because they either don't know about it because most of their education is sponsored by the drug companies and because the FDA sits on her hands instead of doing their job in protecting the general public or because they make pretty good money by prescribing those drugs.
Unless you do your own research and specifically ask you are not being told the risks and side effects. People have a right to know what the risks are so THEY can make an educated decision and decide if the benefits outweigh the risks.

However, with the FDA "approval" people believe the drugs are safe and the drug industry uses the FDA seal of approval as a marketing tool. Not only that but they use the FDA to squash any independent, small, innovative researchers.

That to me is censorship! Talk about being hoodwinked!

By the way, Thalidomide was approved by the FDA in 1998 for the use in ENL and in 2006 accelerated approval was granted by the FDA for use in multiple myeloma.

 

[rjroubi]

Robin:
I still am not clear why you feel that those who choose alternatives are being " hoodwinked". Isnt it the right of every American to know all the options, all the points of view & then have the responsibility to investigate & then the right to choose?

As far as the statement: "Biased reporting by the television industry on any level....pharmaceutical or otherwised (ie. Oprah) simply shouldn't be allowed"....

I'm sorry that feels like censorship to me - I do not want ANY government agency or advertising company dictating the information I can listen to. Because I choose diffferently than you I am not hoodwinked. Who's to say that those going down the path of FDA approved only items arent being hoodwinked?

When I watched the program I expected to hear balance and expert testimony from both sides.....it was clearly a spectacle. There absolutely was no balance of opinions. Heck, there were just opinions.The expert from Northwestern University's medical school was given second stage....heck, she wasn't even on the stage. (A pharmaceutical company giving a continuing education program wouldn't dare pull a stunt like that.) The same unbalanced presentation occurred when Oprah had Robin McGraw promoting her book. People should be presented with all the facts....not just, the "Oh, this is so wonderful side."

A hormone added to your body is a drug. I don't care what spin they put on it.

My problem was with the "that biased program"....not people choosing alternatives. Everyone has the right to choose. Be informed....but do remember you are choosing at your own risk. If something goes wrong who do you blame?

I don't think of it so much as trail blazing.....I think of it more like being a guinea pig.

 

[pixiesis]

If you watch Oprah regularly you'd know that she routinely give Doctors center stage. Dr. Oz, Dr. Christiane Northrup and others are regular guests. As far as I'm concerned, it's perfectly okay for her to give someone else center stage and have the Docs there on a "second" stage. Suzanne Somers was her guest for that episode. The Northwestern Doc (forget her name) was extremely emotional and shrill, and was clearly angry at Suzanne. I wanted to hear her point of view, but she was hard to listen to because of her hostile stance. Oprah gave her the floor however, and Dr. Northrup. I'm not surprised that the Northwestern doctor later complained--she was clearly upset and it obscured her expertise. I walked away from that episode confused about the whole thing, to be honest.

Amy

 

[hiitdogs]

I don't think of it so much as trail blazing.....I think of it more like being a guinea pig.

What do you think people in clinical trials are? Or even people prescribd drugs that are already approved by the FDA, in most cases we don't know what the long-term side effects of drugs are.

The difference between an FDA approved drug and other drugs is that the FDA approval gives people a false sense of security.

I don't understand, most tv reports or magazine articles are biased depending on who is behind it. You never get the full picture of anything. To rely on a single report, article, book or even doctor to get full and accurate information is silly.A talk show shouldn't be a person's sole information source. It can spark people's interest in a subject but it certainly shouldn't be expected to be a complete and unbiased report.

 

[hottiescientist]

Two things, one a question and another a comment.

1) For those who have done HRT and have had success -- first, that's so wonderful! -- and second, did you guys do it through a physician that specializes in it (and did they suggest FDA approved or the bioidenticials) or have you just done self HT with bioidenticals? Because the bulk of what the article and I think medical experts find disturbing about Somers is that she's doing it all by herself (and maybe some of you guys think she's done all the research she needs to do but Somers can't even run a blood test on her own to keep track of how her body is responding).

2) Carola and others, you have every right not to trust the FDA at all. And I agree that people think that just because the FDA approves a drug, it must be safe. A drug is a drug and what may work on some people may kill another. But I do want to just mention a couple things...

It's true that the FDA has screwed up on some medication and that there are certain individuals who are in the purses of the Pharm companies. But its also true that there are a lot of people who are good, responsible men and women trying to test the safety of food and drug products and for the most part, they're doing ok given the thousands of medications that are on the market not killing thousands of people. But its still ok not to trust them, so please don't think I'm saying that, because everyone has the right to make their own choice.

But even if you think its false, you can access the data from the various tests and trials (with some effort) from the FDA. You cannot access *any* data for bio-identical trials or tests. You can poll for the information of quality and safety out of the companies that make FDA drugs by both the government AND independent safety groups outside the government. There is no entity TO check for the safety and quality of bioidenticals. Now, if you think then that the drugs approved by the FDA and bioidenticals have the same credibility (or if you think bioidenticals have more), that's fine but I think a lot of people may think twice when there are no quality checks for a drug that mimics the hormones in your body.

 

[pixiesis]

Because the bulk of what the article and I think medical experts find disturbing about Somers is that she's doing it all by herself (and maybe some of you guys think she's done all the research she needs to do but Somers can't even run a blood test on her own to keep track of how her body is responding).

This is not accurate. I definitely remember that Somers DOES have a doctor who prescribes her medicines and she and Oprah both repeatedly said that women must consult with a doctor. NO ONE advised women to go off and start using hormones without seeing a doctor.

Amy

 

[hottiescientist]

This is not accurate. I definitely remember that Somers DOES have a doctor who prescribes her medicines and she and Oprah both repeatedly said that women must consult with a doctor. NO ONE advised women to go off and start using hormones without seeing a doctor.

Amy

If that's the case, then that's good, but I got the impression -- though its an impression -- that she was doing a lot of stuff own her own. (Though makes you wonder which doctor wants you to take that many supplements. Why would a doctor tell her to take progesterone after a hysterectomy? )

 

[hiitdogs]

But even if you think its false, you can access the data from the various tests and trials (with some effort) from the FDA.

You can access only the data from the various tests and trials that the drug companies deem favorable and are willing to release.

What about safety checks on FDA approved drugs? That's pretty non-existent. Just last year Baxter Pharmaceuticals distributed contaminated Heparin which killed 4 people and adversely effected thousands of others. Why? Because Baxter wanted to maximize their profits and import the active ingredient cheaper from China. And where was the FDA? Nowhere to be seen, they didn't even inspect that plant although it is their obligation to do so.

I don't think that BHRT would be a viable option for me but quite frankly I would trust an American pharmacist a little more than a factory in China.

 

[hiitdogs]

Though makes you wonder which doctor wants you to take that many supplements. Why would a doctor tell her to take progesterone after a hysterectomy? )

In my treatment, at times I was on 20 different supplements.

After hysterectomy progesterone is often prescribed to prevent osteoporosis.