I just finished up reading the Weston Kosova and Pat Wingert article from the June 8th edition of Newsweek Magazine. It is a critique of the pseudoscience that routinely makes it onto broadcasts of the Oprah Winfrey Show.
The authors go down the list of questionable medical advice that is given out on the show by activists like Suzanne Somers and Jenny McCarthy and proceeds on to criticize "experts" like Dr. Christiane Northrup and dermatologists Karyn Grossman and Brandith Irwin.
Case by case, the Newsweek duo offers real medical findings that contradict what is offered to viewers of the show on a regular basis. Many times, Oprah wholeheartedly endorses unproven and medically risky techniques without giving any time to the opposing viewpoint.
First up in the article is a discussion of Suzanne Somers and her practice of administering hormone treatments and taking 60 supplements a day. She also partakes in some other practices such as:
she also starts each day by giving herself injections of human growth hormone, vitamin B12 and vitamin B complex. In addition, she wears "nanotechnology patches" to help her sleep, lose weight and promote "overall detoxification." If she drinks wine, she goes to her doctor to rejuvenate her liver with an intravenous drip of vitamin C. If she's exposed to cigarette smoke, she has her blood chemically cleaned with chelation therapy. In the time that's left over, she eats right and exercises, and relieves stress by standing on her head. Somers makes astounding claims about the ability of hormones to treat almost anything that ails the female body. She believes they block disease and will double her life span. "I know I look like some kind of freak and fanatic," she said. "But I want to be there until I'm 110, and I'm going to do what I have to do to get there."
The authors go on to say that on the Oprah show that featured Somers, doctors who were critical of her practices were not given a fair chance to debate the validity of her practices. When Newsweek contacted a doctor to address concerns of what Somers and Oprah were advocating for this was the response:
Outside Oprah's world, there isn't a raging debate about replacing hormones. Somers "is simply repackaging the old, discredited idea that menopause is some kind of hormone-deficiency disease, and that restoring them will bring back youth," says Dr. Nanette Santoro, director of reproductive endocrinology at Albert Einstein College of Medicine and head of the Reproductive Medicine Clinic at Montefiore Medical Center.
Okay one down, now onto Jenny McCarthy. I'm sure most of us are aware of her activism on autism and how she cites the onset of her son's autism after an MMR vaccine he was given as a toddler as her evidence of the causal relationship between the two. She does not specifically blame the vaccine itself, rather she believes that the chemicals used in preserving vaccines are the culprit. McCarthy's story:
McCarthy is certain that her son contracted autism from the measles, mumps and rubella (MMR) vaccination he received as a baby. She told Oprah that the morning he went in for his checkup, her instincts told her not to allow the doctor to give him the vaccine. "I said to the doctor, I have a very bad feeling about this shot. This is the autism shot, isn't it? And he said no, that is ridiculous; it is a mother's desperate attempt to blame something on autism. And he swore at me." The nurse gave Evan the shot. "And not soon thereafter," McCarthy said, "boom, soul gone from his eyes."
The problem is, of course, the complete lack of scientific evidence that could back up her assertion:
Studies have found some genetic and environmental links that may increase the risk of autism, but its causes are still unknown. The baffling rise in the number of autism cases has loosely coincided with an increase in the number of childhood immunizations. Yet researchers have not found a link between the vaccines and autism.
Now here's where Oprah becomes a part of the problem:
But back on the Oprah show, McCarthy's charges went virtually unchallenged. Oprah praised McCarthy's bravery and plugged her book, but did not invite a physician or scientist to explain to her audience the many studies that contradict the vaccines-autism link. Instead, Oprah read a brief statement from the Centers for Disease Control saying there was no science to prove a connection and that the government was continuing to study the problem. But McCarthy got the last word.
We're starting to see a trend here. Now onto Dr. Christiane Northrup, an ob/gyn who:
stresses alternative therapies and unseen connections between the soul and the body that she believes conventional doctors overlook, but that she can see. She has written about how she has used Tarot cards to help diagnose her own illnesses. (On her Web site, she sells her own "Women's Wisdom Healing Cards.") In other words, she gets right to the center of Oprah's search for hidden mystical meanings. Oprah says she reads Northrup's menopause book "just like it's the Bible. It's the book next to my bed. I read the Bible. I read that book."
Tarot cards used to diagnose illness. Alas, Oprah has turned to Northrup in the past for advice including when she came down with a thyroid condition. Here's a little exchange from a show with Northrup:
Oprah : So your body ... is only manifesting what's really going on with your spirit?
Northrup: But your intellect doesn't know it. This is the important part. It's not—you're not causing this deliberately ... It's your soul bringing it to your attention.
Oprah: Right. It's your soul trying to speak to you.
Okaaay...(Backing away slowly)
And here's Northrup giving more bad medical advice, which Oprah provides no challenge to:
Northrup advises that in addition to conventional thyroid medication, women should consider taking iodine supplements.
That is just what they shouldn't do, says Dr. David Cooper, a professor of endocrinology at Johns Hopkins medical school who specializes in thyroid disease. "She is mixing truth with fantasy here," he says. First, "thyroid disease has nothing to do with women being downtrodden. She makes it sound like these women brought it on themselves." Cooper agrees that thyroid patients should seek thyroid hormone treatment to bring the symptoms under control.
The last example from the article concerns new plastic surgery techniques which are often hyped on Oprah's show as the next great discovery, even before the medical community has weighed in on them. One example of a procedure that was hyped on Oprah's show was the "thread lift", in which Grossman:
poked multiple holes on each side of Sandy's face near her ears, eyes and cheekbones, then pulled through thin threads under the skin. The threads caught in her flesh, hoisting her tissue up and back. "Threads are tied off," Oprah enthused, "and a one-hour lunch-break lift."
And of course, the medical community has to weigh in and rain on the super-fantastic-happy-fun time parade again:
Yet according to Plastic Surgery Practice, an industry magazine, some doctors reported that "over time, the suture tends to act like a 'cheese wire'," cutting through delicate facial tissue. Some patients who underwent another version of the procedure, which used barbed threads, experienced bunching of the skin, dimples and scars. Others complained the left and right sides of their faces no longer matched up due to "migration of the sutures." One of the most common complaints, though, was that they couldn't see any improvement at all.
The article also points out that after this procedure was discredited, she never bothered to go back and do an update for her viewers or warn them about the risks involved.
The other procedure hyped, then later discredited was Thermage, a way of smoothing "wrinkles by using radio waves to tighten skin". Interesting...of course Oprah failed to mention on her show that Thermage:
hurt, a lot. And it didn't always work. On her own Web site, Irwin acknowledges that in those early days of Thermage, "the treatments were painful without sedation (we sedated everyone in our office), and the results were inconsistent." O magazine recently ranked Thermage as a four on a pain scale of one to five. Five was "agony." There was also no mention on the show about the potential risks, which included burns and scars.
The Newsweek article does give Oprah credit for featuring a few doctors such as Dr. Mehmet Oz, who actually gives great advice on subjects like nutrition and exercise. I give her credit for that as well, but the other cases still stand as a testament of her willingness to push pseudo scientific cures for contemporary medical problems as well as her inability to provide her viewers with the potential downsides of these practices.
What I see as the point of writing this is that whenever we see pseudoscience being taken seriously or offered as the best or only way of treating a disease or medical problem, we must speak up in order to counteract the people pushing this pseudoscience.
I think that if you are someone who is willing to believe that vaccines cause autism or that when you get sick it is just your soul talking to you that you'll be more likely to believe that the Earth is 6000 years old or that humans appeared on the planet in their present form. These views are caustic to the political discourse in this country and should be eradicated. It is our responsibility as progressives to promote a culture and a civil society that values scientific research and intellectual thought.
Oprah has 40 million viewers each week tuning in to watch her. She needs to be taken to task on this and I have provided a link to contact the show in order to express your disapproval of her unwillingness to provide both sides of the story.
I actually filled it out and sent it in. I wrote in the message that Oprah should do a show about how a lot of the medical advice and opinion given out by Suzanne Somers, Christiane Northrup, Jenny McCarthy and others is bogus. It takes a minute and maybe if they get enough of these they'll do a show to expose the bullshite. We can only hope...
Wish Away Cancer! Get A Lunchtime Face-Lift! Eradicate Autism! Turn Back The Clock! Thin Your Thighs! Cure Menopause! Harness Positive Energy! Erase Wrinkles! Banish Obesity! Live Your Best Life Ever!
Weston Kosova and Pat Wingert
NEWSWEEK
From the magazine issue dated Jun 8, 2009
In January, Oprah Winfrey invited Suzanne Somers on her show to share her unusual secrets to staying young. Each morning, the 62-year-old actress and self-help author rubs a potent estrogen cream into the skin on her arm. She smears progesterone on her other arm two weeks a month. And once a day, she uses a syringe to inject estrogen directly into her vagina. The idea is to use these unregulated "bio-identical" hormones to restore her levels back to what they were when she was in her 30s, thus fooling her body into thinking she's a younger woman. According to Somers, the hormones, which are synthesized from plants instead of the usual mare's urine (disgusting but true), are all natural and, unlike conventional hormones, virtually risk-free (not even close to true, but we'll get to that in a minute).
Next come the pills. She swallows 60 vitamins and other preparations every day. "I take about 40 supplements in the morning," she told Oprah, "and then, before I go to bed, I try to remember … to start taking the last 20." She didn't go into it on the show, but in her books she says that she also starts each day by giving herself injections of human growth hormone, vitamin B12 and vitamin B complex. In addition, she wears "nanotechnology patches" to help her sleep, lose weight and promote "overall detoxification." If she drinks wine, she goes to her doctor to rejuvenate her liver with an intravenous drip of vitamin C. If she's exposed to cigarette smoke, she has her blood chemically cleaned with chelation therapy. In the time that's left over, she eats right and exercises, and relieves stress by standing on her head. Somers makes astounding claims about the ability of hormones to treat almost anything that ails the female body. She believes they block disease and will double her life span. "I know I look like some kind of freak and fanatic," she said. "But I want to be there until I'm 110, and I'm going to do what I have to do to get there."
That was apparently good enough for Oprah. "Many people write Suzanne off as a quackadoo," she said. "But she just might be a pioneer." Oprah acknowledged that Somers's claims "have been met with relentless criticism" from doctors. Several times during the show she gave physicians an opportunity to dispute what Somers was saying. But it wasn't quite a fair fight. The doctors who raised these concerns were seated down in the audience and had to wait to be called on. Somers sat onstage next to Oprah, who defended her from attack. "Suzanne swears by bioidenticals and refuses to keep quiet. She'll take on anyone, including any doctor who questions her."
That would be a lot of doctors. Outside Oprah's world, there isn't a raging debate about replacing hormones. Somers "is simply repackaging the old, discredited idea that menopause is some kind of hormone-deficiency disease, and that restoring them will bring back youth," says Dr. Nanette Santoro, director of reproductive endocrinology at Albert Einstein College of Medicine and head of the Reproductive Medicine Clinic at Montefiore Medical Center. They just don't need as much once they get past their childbearing years. Unless a woman has significant discomfort from hot flashes—and most women don't—there is little reason to prescribe them. Most women never use them. Hormone therapy can increase a woman's risk of heart attacks, strokes, blood clots and cancer. And despite Somers's claim that her specially made, non-FDA-approved bioidenticals are "natural" and safer, they are actually synthetic, just like conventional hormones and FDA-approved bioidenticals from pharmacies—and there are no conclusive clinical studies showing they are less risky. That's why endocrinologists advise that women take the smallest dose that alleviates symptoms, and use them only as long as they're needed.
"It completely blew me away that Oprah would go to her for advice on this topic," says Cynthia Pearson, the executive director of the nonprofit National Women's Health Network and an authority on hormone therapy. "I have to say, it diminished my respect."
Somers says it's mainstream doctors who need to get their facts straight. "The problem is that our medical schools do not teach this," she said in a February interview with NEWSWEEK. She believes doctors, scientists and the media are all in the pocket of the pharmaceutical industry. "Billions are spent on marketing drugs, and these companies also support academic research." Free from these entanglements, Somers can see things clearly. "I have spent thousands of hours on this. I've written 18 books on health. I know my stuff."
On Oprah's show, there is one opinion more equal than others; and by the end of the program there was no doubt where Oprah herself stood on the issue. She told her audience that she found Somers's bestselling books on bioidentical hormones "fascinating" and said "every woman should read" what she has to say. She didn't stop there. Oprah said that although she has never had a hot flash, after reading Somers she decided to go on bioidenticals herself. "After one day on bioidentical estrogen, I felt the veil lift," she wrote in O, The Oprah Magazine. "After three days, the sky was bluer, my brain was no longer fuzzy, my memory was sharper. I was literally singing and had a skip in my step." On the show, Oprah had her own word of warning for the medical establishment: "We have the right to demand a better quality of life for ourselves," she said. "And that's what doctors have got to learn to start respecting."
All in all, it was a perfect hour of tabloid television. Who could look away from Suzanne Somers's sad but captivating efforts to turn back time? And if there was a stab of guilt in the pleasure we took in the spectacle, Oprah was close by to ease our minds, to reassure us, with the straightest face, that it was all in the name of science and self-improvement. Oprah routinely grabs viewers with the sort of tales of the strange and absurd that might be found a few clicks over on Maury Povich or Jerry Springer: women who leave their husbands for other women (another recent Oprah episode); a 900-pound mom (ditto). But there is a difference. Oprah makes her audience feel virtuous for gaping at the misfortunes of others. What would be sniffed at as seamy on Maury is somehow praised as anthropology on Oprah. This is Oprah's special brilliance. She is a gifted entertainer, but she makes it seem as though that is beside the point. Oprah is not here to amuse you, she is here to help you. To help you understand your feelings; drop those unwanted pounds; look and feel younger; get your thyroid under control; to smooth your thighs, nip and tuck your wrinkles, awaken your senses and achieve spiritual tranquillity so that you can at last be free to "Live Your Best Life."
Oprah takes these things very seriously. They are, after all, the answers she hopes to find for herself. If Oprah has an exquisite ear for the cravings and anxieties of her audience, it is because she shares them. Her own lifelong quest for love, meaning and fulfillment plays out on her stage each day. In an age of information overload, she offers herself as a guide through the confusion.
Her audience cannot get enough. After more than two decades on the air, the Oprah franchise continues to expand. Forty million people tune in to watch her television show each week. O magazine, which features her picture on every cover, sells more than 2 million copies each month. She has her own satellite radio channel and a very popular Web site. Forbes puts Oprah's personal fortune at $2.7 billion. Her empire is about to get bigger. Oprah has made a deal to launch her own cable television channel that will reach 70 million homes. It will be called, of course, the Oprah Winfrey Network and will include Oprah-approved programming on health and living well. In announcing the deal, Oprah said, "I will now have the opportunity to do this 24 hours a day on a platform that goes on forever."
Oprah says things like this without irony. But really, how could it not go to her head, even a little? Her most ardent fans regard her as an oracle. If she mentions the title of a book, it goes to No. 1. If she says she uses a particular wrinkle cream, it sells out. At Oprah's retail store in Chicago, women can purchase used shoes and outfits that she wore on the show. Her viewers follow her guidance because they like and admire her, sure. But also because they believe that Oprah, with her billions and her Rolodex of experts, doesn't have to settle for second best. If she says something is good, it must be.
This is where things get tricky. Because the truth is, some of what Oprah promotes isn't good, and a lot of the advice her guests dispense on the show is just bad. The Suzanne Somers episode wasn't an oddball occurrence. This kind of thing happens again and again on Oprah. Some of the many experts who cross her stage offer interesting and useful information (props to you, Dr. Oz). Others gush nonsense. Oprah, who holds up her guests as prophets, can't seem to tell the difference. She has the power to summon the most learned authorities on any subject; who would refuse her? Instead, all too often Oprah winds up putting herself and her trusting audience in the hands of celebrity authors and pop-science artists pitching wonder cures and miracle treatments that are questionable or flat-out wrong, and sometimes dangerous.
Oprah would probably not agree with this assessment. She declined to be interviewed for this article, but in a statement she said, "The guests we feature often share their first-person stories in an effort to inform the audience and put a human face on topics relevant to them. I've been saying for years that people are responsible for their actions and their own well-being. I believe my viewers understand the medical information presented on the show is just that—information—not an endorsement or prescription. Rather, my intention is for our viewers to take the information and engage in a dialogue with their medical practitioners about what may be right for them."
The first-person story that, as Oprah says, puts "a human face on topics" is an important part of the show's success. Perhaps Oprah's most attractive quality, and one that sets her apart from other daytime hosts, is that she abhors the celebration of victimhood. She succeeded despite a childhood of abuse, and her own experience left her with very little tolerance for people who indulge in self-pity or blame cruel fate for their troubles. She often features regular people or, even better, celebrities, who have met challenges in their lives.
In 2007, Oprah invited Jenny McCarthy, the Playboy model and actress, to describe her struggle to find help for her young son. When he was 2½, Evan suffered a series of seizures. A neurologist told McCarthy he was autistic. "So what do you think triggered the autism?" Oprah asked McCarthy. "I know you have a theory."
McCarthy is certain that her son contracted autism from the measles, mumps and rubella (MMR) vaccination he received as a baby. She told Oprah that the morning he went in for his checkup, her instincts told her not to allow the doctor to give him the vaccine. "I said to the doctor, I have a very bad feeling about this shot. This is the autism shot, isn't it? And he said no, that is ridiculous; it is a mother's desperate attempt to blame something on autism. And he swore at me." The nurse gave Evan the shot. "And not soon thereafter," McCarthy said, "boom, soul gone from his eyes."
McCarthy is now the most prominent voice in a small but vocal movement of parents with autistic children who are demanding action from the government. They believe that chemicals once used to preserve vaccines, combined with the increase in the number of shots kids get today, have created an epidemic of autism; and that doctors, the government, the media and drug companies are hiding or ignoring the truth. McCarthy declined an interview, but in a statement she said, "I understand that vaccines are an important part of keeping us alive today. My problem is with the ingredients in some vaccines that can become toxic when introduced to children with vulnerable immune systems. I want those children to be able to delay vaccines that could cause them harm."
It is easy to see why parents like McCarthy have latched onto vaccines as the culprit. They want answers, and sadly there are few. Studies have found some genetic and environmental links that may increase the risk of autism, but its causes are still unknown. The baffling rise in the number of autism cases has loosely coincided with an increase in the number of childhood immunizations. Yet researchers have not found a link between the vaccines and autism. Here is what we do know: before vaccinations, thousands of children died or got sick each year from measles, mumps and rubella.
But back on the Oprah show, McCarthy's charges went virtually unchallenged. Oprah praised McCarthy's bravery and plugged her book, but did not invite a physician or scientist to explain to her audience the many studies that contradict the vaccines-autism link. Instead, Oprah read a brief statement from the Centers for Disease Control saying there was no science to prove a connection and that the government was continuing to study the problem. But McCarthy got the last word. "My science is named Evan, and he's at home. That's my science." Oprah might say that McCarthy was just sharing her first-person story and that Oprah wasn't endorsing her point of view. But by the end of the show, the take-away message for any mother with young kids was pretty clear: be afraid.
Oprah told viewers that McCarthy would be available to answer questions and give guidance later that day on Oprah.com. One viewer went online to ask McCarthy what she would do if she could do it all over again. "If I had another child," McCarthy answered, "I would not vaccinate." A mother wrote in to say that she had decided not to give her child the MMR vaccine because of fears of autism. McCarthy was delighted. "I'm so proud you followed your mommy instinct," she wrote. A year later, McCarthy was back on the show for an episode about "Warrior Moms," which gave her another opportunity to expand on her claims about vaccines and autism. Oprah must have liked what she heard. McCarthy became a semiregular guest on the show, and in May, Oprah announced that her production company had signed McCarthy for a talk show of her own.
McCarthy is not the only guest who has warned Oprah's viewers off vaccines. Last summer Dr. Christiane Northrup, a physician and one of Oprah's regular experts, took questions from the audience. One woman asked about the HPV vaccine, which protects women against a sexually transmitted virus that can cause cervical cancer. Northrup advised against getting the shot. "I'm a little against my own profession," she said. "My own profession feels that everyone should be vaccinated." But Northrup cautioned, "There have been some deaths from the vaccine." She suggested a different approach. "Where I'd put my money is getting everybody on a dietary program that would enhance their immunity, and then they would be able to resist that sort of thing. All right?"
It is true that of the millions of women who have received the vaccine, 32 have died in the days or weeks afterward. But in each case, the Centers for Disease Control and the Food and Drug Administration investigated the deaths and found that they were coincidental and were not related to the shot. "This is a very safe vaccine," says Susan Wood, a research professor in the School of Public Health at George Washington University and the former head of the FDA's Office of Women's Health. "Because of the power and influence that Oprah's show has, she should make an extra effort to be clear." Neither did Oprah question Northrup's assertion that women can stop the spread of a cancer-causing sexually transmitted disease by eating healthy foods. There is, Wood says dryly, "no evidence that money spent on general health promotion" will do that. Reached by phone, Northrup herself now concedes she isn't certain that anyone has died from the vaccine. And she didn't mean to leave the impression that women should avoid it. "I would say that there is a chance that they could be injured from it, but I wouldn't say not to take it."
Northrup holds a special place in Oprah's constellation of regular guests. A Dartmouth-educated ob-gyn, she stresses alternative therapies and unseen connections between the soul and the body that she believes conventional doctors overlook, but that she can see. She has written about how she has used Tarot cards to help diagnose her own illnesses. (On her Web site, she sells her own "Women's Wisdom Healing Cards.") In other words, she gets right to the center of Oprah's search for hidden mystical meanings. Oprah says she reads Northrup's menopause book "just like it's the Bible. It's the book next to my bed. I read the Bible. I read that book." (Disclosure: NEWSWEEK correspondent Pat Wingert, who worked on this article, and contributor Barbara Kantrowitz are coauthors of a book on menopause.)
Oprah turned to Northrup for advice in 2007, when, as she put it, she "blew out" her thyroid after a stressful season of work and travel. She felt sick and drained and she gained weight. She asked the doctor to come on the show to explain what was going on. "When I called her to talk about this whole thyroid issue," Oprah told the audience, "she always connects the mind, the body and the spirit."
Thyroid dysfunction, which affects millions of Americans (mostly women), occurs when the thyroid gland located in the neck produces too much or too little thyroid hormone. Too much (hyperthyroidism) and the metabolism races, sometimes causing anxiety and weight loss. Too little (hypothyroidism) and it slows, which, if severe, can lead to depression and weight gain. Many things can trigger the disease, especially autoimmune disorders.
But Northrup believes thyroid problems can also be the result of something else. As she explains in her book, "in many women, thyroid dysfunction develops because of an energy blockage in the throat region, the result of a lifetime of 'swallowing' words one is aching to say."
On the show, she told Oprah that "your body gives you signals: 'Hey, you've been putting too much stuff under the carpet ...' "
Oprah: So your body ... is only manifesting what's really going on with your spirit?
Northrup: But your intellect doesn't know it. This is the important part. It's not—you're not causing this deliberately ... It's your soul bringing it to your attention.
Oprah: Right. It's your soul trying to speak to you.
An interesting theory—but is there anyone who believes that what Oprah suffers from is an inability to express herself? She didn't make it clear on the show what form of the disease she had, or what her doctors believed brought it on. She shared with her audience that she took thyroid medication and spent a month relaxing in Hawaii, where she ate fresh foods and drank soy milk. Northrup advises that in addition to conventional thyroid medication, women should consider taking iodine supplements.
That is just what they shouldn't do, says Dr. David Cooper, a professor of endocrinology at Johns Hopkins medical school who specializes in thyroid disease. "She is mixing truth with fantasy here," he says. First, "thyroid disease has nothing to do with women being downtrodden. She makes it sound like these women brought it on themselves." Cooper agrees that thyroid patients should seek thyroid hormone treatment to bring the symptoms under control. But, he says, Oprah should have stayed clear of soy milk. "If you're hypothyroid and you're taking thyroid medication, you do not want to be taking soy. It will block your body's ability to absorb the medication."
Iodine, he says, can be even riskier. "[Northrop] says iodine deficiency is more common in women, when in reality it's not very common in women at all. This is a myth." The thyroid gland, he says, is extremely sensitive to iodine. "If you have mild hypothyroidism, taking iodine will make it worse."
"The problem is that this all has the aura of being scientific when a lot of it is wrong, or not proven or just utter hogwash," Cooper says. "No wonder it sounds very credible to the patients, and in my opinion, that's even worse. If it was all complete rubbish, people would be more likely to see it for what it really is."
All this dreary talk of measles and cancer and thyroids. Wouldn't you rather "Stop the Clock on Aging!" Hear about "The Latest Age-Defying Breakthroughs!" Get the skinny on the miracle "Lunchtime Face-Lift Which Means No Cutting and No Down Time!" These are all teaser lines Oprah has recited on her show. Oprah hasn't had plastic surgery herself, and she has aired the cautionary tales of desperate, youth-obsessed women who ruined their faces with too many procedures. Yet she seems fascinated with the subject and has been among the first to promote the newest treatments. In 2004, Oprah debuted a new "groundbreaking" procedure on the show called a thread lift. Her guest, dermatologist Karyn Grossman, called it "pretty much as close as you can get to a face-lift without actually cutting."
Oprah liked the sound of that. "Well, let's see what this is, y'all!" she told the audience. She played a video of Grossman performing the procedure on a 61-year-old woman named Sandy. Grossman poked multiple holes on each side of Sandy's face near her ears, eyes and cheekbones, then pulled through thin threads under the skin. The threads caught in her flesh, hoisting her tissue up and back. "Threads are tied off," Oprah enthused, "and a one-hour lunch-break lift."
Sandy was in the audience to show off the results. Oprah flashed the "before" picture, what appeared to be a no-makeup shot under harsh lighting. She looked like a 61-year-old woman with no makeup. Then, the big reveal. Sandy emerged under the warm studio bulbs, her face heavily pancaked with makeup. She looked like a 61-year-old woman heavily pancaked with makeup. It was difficult to tell if there was any difference. But Sandy pronounced herself pleased with the results, and the audience burst into applause.
Oprah said almost nothing about possible risks. "It is a relatively painless procedure, I'm told," she said. "Scarring is minimal, and recovery time is measured in days instead of weeks." Yet according to Plastic Surgery Practice, an industry magazine, some doctors reported that "over time, the suture tends to act like a 'cheese wire'," cutting through delicate facial tissue. Some patients who underwent another version of the procedure, which used barbed threads, experienced bunching of the skin, dimples and scars. Others complained the left and right sides of their faces no longer matched up due to "migration of the sutures." One of the most common complaints, though, was that they couldn't see any improvement at all.
The thread-lift craze, such as it was, did not last long. "You never hear anything about them now," says Dr. Alan Gold of the American Society for Aesthetic Plastic Surgery. "That procedure turned out to have major downsides and rapidly fell into disrepute."
You would not know this from watching Oprah. The New York Times noted problems with the treatment in a 2006 article specifically about the Oprah show's tendency to hype plastic surgery without mentioning the risks. But Oprah never circled back to warn her viewers that they just might want to cross it off their to-do list. Grossman says Oprah never gave her an opening to talk about the downsides, and in the moment it didn't occur to her to raise them herself. If she went on the show again, she says, she'd do things differently. "We should have said, 'This is a new procedure. It looks interesting and exciting, but we don't know everything about it yet and there may be risks that haven't come up yet'."
Oprah was also one of the first to feature a procedure called Thermage. It smooths wrinkles by using radio waves to tighten skin. The Times article noted that Oprah was one of the first to call attention to the $30,000 Thermage machines after they were released in 2003. "The show drove so much interest that our sales reps were selling machines over the phone," the president of the company told the paper. In the years since, Oprah has featured the product numerous times on her TV show and Web site and in her magazine.
In February 2004, dermatologist Brandith Irwin appeared on an episode called "Look Younger! Live Longer!" The show aired again twice over the next two years. Irwin came on the program to promote a book and to talk about cosmetic procedures. She had nothing but praise for Thermage, which was then still a relatively new treatment. "I tell my patients they'll lose about half a day, and then you go back to your normal activities the next day." Neither Oprah nor Irwin said anything about a significant downside to the procedure: it hurt, a lot. And it didn't always work. On her own Web site, Irwin acknowledges that in those early days of Thermage, "the treatments were painful without sedation (we sedated everyone in our office), and the results were inconsistent." O magazine recently ranked Thermage as a four on a pain scale of one to five. Five was "agony." There was also no mention on the show about the potential risks, which included burns and scars.
The makers of Thermage say the latest generation of machines are more effective and far less painful. And the risk of complications is very low. Stephen Fanning, the company's CEO, says Oprah certainly helped drive sales and interest. But he is uncomfortable when his product is promoted without giving people the whole picture. "I think any time you're dealing with a cosmetic device, you always have to present a balanced approach. Oprah didn't." Fanning believes Oprah should have made it clear that Thermage isn't for everyone. "Who isn't a good candidate? Someone who smokes a lot, someone who consumes a lot of alcohol, is not going to get the kind of results they want. The same can be said for someone who has spent a lot of time in the sun."
Yet Irwin says there was no time on the Oprah show to go into these kinds of details. "It was meant to stimulate interest, and then people could go find out about it from their doctor and decide what's appropriate for them. That's what the Web site and the book and office visits are for," Irwin says. "I am in sympathy with the idea of doing better medical segments," she says. "We can't do that in 15 seconds."
Right about now is when you might be asking, is there anything Oprah gets right? In fact, there is. For one, she gives excellent diet and fitness tips. Two of her longest-serving resident experts, Dr. Mehmet Oz and trainer Bob Greene, routinely offer sound, high-quality advice to Oprah and her audience on how to lose weight and improve overall health. For the most part, it is free of the usual diet-industry hype, perhaps because so many of her viewers are on to those scams by now. Oz's and Greene's philosophy amounts to: eat nutritious foods, and exercise.
Oz, fit and handsome, is particularly good at connecting with Oprah's audience. He is a cardiac surgeon at Columbia University and generally sticks to the facts. He is also a natural showman who comes onstage in surgical scrubs, as if he might be asked to perform an emergency heart transplant at any moment. He sometimes arrives carrying preserved body parts as visual aids. On one show, "Everybody Poops," Oz conducted a genuinely fascinating seminar on what comes out the other end. (It should be shaped like an S and "hit the water like a diver from Acapulco." Who knew?)
Oz isn't without his faults. He sometimes keeps quiet on the show when Oprah's out-there experts are spouting their questionable theories. There seems to be an unwritten rule that one Oprah expert may not criticize or correct another, and Oz has an interest in keeping Oprah happy. She has turned his books into mega-bestsellers, and features him on her Web site and in her magazine. Her production company is also bankrolling his own syndicated TV show, Dr. Oz, which debuts in the fall. "My role on The Oprah Winfrey Show was never to assume editorial control or in any way to debate the position that other guests might take," Oz said in a statement. "My participation on the program, much like that of any physician on television, was never intended to replace the discussion necessary between patients and their personal health-care provider."
Oprah, of course, is notoriously bad at sticking with the advice Oz and Greene dispense, especially when it comes to her weight. She laments her inability to keep off the pounds. In January she embarked on yet another attempt to trim down, which means all of Oprah's viewers are now—actually or vicariously—on a diet too. She will lose the weight, and there will be much remarking upon it. But then, in a year, or two, or three, experience teaches us that the fat will likely come back. And she will lament. And then she will do it all over again, with a whole new set of experts armed with the latest breakthrough theories on how to live our next best life and all-new, must-have books and gadgets and ointments to ease the way.
At some point, it would seem, people will stop looking to Oprah for this kind of guidance. This will never happen. Oprah's audience admires her as much for her failings as her successes. In real life, she has almost nothing in common with most of her viewers. She is an unapproachable billionaire with a private jet and homes around the country who hangs out with movie stars. She is not married and has no children. But television Oprah is a different person. She somehow manages to make herself believable as a down-to-earth everywoman. She is your girlfriend who struggles to control her weight and balance her work and personal life, just like you. When she recently related the story of how humiliated she felt when she arrived for a photo shoot to find that she couldn't fit into the clothes she was supposed to wear, she knew she had every member of the audience in her hand. Oprah's show is all about second and third and fourth chances to fix your life, and the promise that the next new thing to come along will be the one that finally works.
This perpetual search for The Answer reached its apex a couple of years ago, when Oprah led the frenzy over The Secret. The video and accompanying book were a rehash of one of the oldest of self-help truisms—"think positive"—refreshed with a dusting of "science." The secret of The Secret was something called the Law of Attraction. As Oprah put it on the show, "It says that the energy, that the thoughts and feelings that you put out into the world, both good and bad, are exactly what is always coming back to you, so you have the life that you have created." Oprah and the teachers of The Secret, as they call themselves, did not mean this metaphorically. They explained that the universe and everything in it are made of vibrating energy, and by thinking positively we can actually "attract" the positive vibrations of the universe and bend them to our will. "You're a field of energy in a larger field of energy," one of The Secret's teachers said. "And like attracts like, and that's very, very scientific."
By harnessing this powerful science, they said, we can have anything we want—happiness, love, fabulous wealth. This was so inspiring to Oprah that she devoted three shows to the product and appeared on Larry King to talk it up more. She said it encapsulated everything she believes. "I've been talking about this for years on my show," she said. "I just never called it The Secret."
On one of the Secret shows, Oprah gave an example of the scientific power of the concept. She said that once, while she was hosting an episode about a man who could blow really big soap bubbles, she was thinking to herself, "Gee, that looks fun. I would like to blow some bubbles." When she returned to her office after the show, there, on her desk, was a silver Tiffany bubble blower. "So I call my assistant," Oprah told the audience. "I say, 'Did you just run out and get me some bubbles? 'Cause I got bubbles by my desk.' And she says, 'No, the bubbles were always there. I bought you bubbles for your birthday and you didn't notice them until today'."
There are many lessons that might be drawn from this anecdote. One is that if you give Oprah a thoughtful gift, she may not bother to notice it or thank you for it. This is not the lesson Oprah took away from her story. Because the way she sees it, her assistant hadn't really given her the gift at all. She gave it to herself. Using the power of The Secret, she said, "I had called in some bubbles."
According to The Secret, however, the Law of Attraction can use the vibrations of the universe to deliver more than just bubbles. The book that Oprah urges everyone to live by teaches that all diseases can be cured with the power of thought alone: "The question frequently asked is, 'When a person has manifested a disease in the body temple … can it be turned around through the power of "right thinking"?' And the answer is absolutely, yes." The book then offers the testimonial of a woman identified as Cathy Goodman. "I was diagnosed with breast cancer. I truly believed in my heart, with my strong faith, that I was already healed. Each day I would say, 'Thank you for my healing'." Goodman watched "very funny movies" to make herself laugh. "From the time I was diagnosed to the time I healed was approximately three months. And that's without any radiation or chemotherapy."
The message got through. In March 2007, the month after the first two shows on The Secret, Oprah invited a woman named Kim Tinkham on the program. She had been diagnosed with breast cancer, and her doctors were urging surgery and chemotherapy. But Tinkham wrote Oprah to say that she had decided to forgo this treatment and instead use The Secret to cure herself. On the show, Oprah seemed genuinely alarmed that Tinkham had taken her endorsement of The Secret so seriously. "When my staff brought this letter to me, I wanted to talk to her," Oprah told the audience. "I said, get her in here, OK?" On air, Oprah urged the woman to listen to her doctors. "I don't think that you should ignore all of the advantages of medical science and try to, through your own mind now because you saw a Secret tape, heal yourself," she said. A few weeks earlier, Oprah could not say enough in praise of The Secret as the guiding philosophy of her life. Now she said that people had somehow gotten the wrong idea. "I think that part of the mistake in translation of The Secret is that it's used to now answer every question in the world. It is not the answer to all questions," she instructed. "I just wanted to say it's a tool. It is not the answer to everything." The Law of Attraction was just one law of many that guide the universe. "Although I live my life that way," Oprah said, "I think it has its flaws."
There were limits to The Secret's healing powers even for Oprah. For there she was, in the months that followed, worrying over her thyroid, ingesting bioidentical hormones and putting on pounds. The Secret warns that all illness and misfortune is caused by attracting the negative power of the universe. "You cannot 'catch' anything unless you think you can," it says. "You are also inviting illness if you are listening to people talking about their illness."
It is possible that this is what happened to Oprah. Listening to so many guests talk about their troubles dampened her energy fields. Yet it may be for the best that things didn't quite work out. What if Oprah had managed to solve all of her problems, to end her search for meaning and fulfillment and spiritual calm and a flatter, firmer stomach by summoning the very power of the universe itself? It might have been hard for her to take Suzanne Somers seriously after that.
The Federal Trade Commission today announced complaints against seven online sellers of alternative hormone replacement therapy (HRT) products, alleging that they made health claims for their natural progesterone creams without supporting scientific evidence. Six of the sellers have signed consent orders barring them from making such unsubstantiated claims in the future. The seventh did not respond to staff’s repeated contacts, and the case will now be heard by an administrative law judge.
“Millions of women seek safe, effective alternatives to hormone replacement therapy,” said Lydia Parnes, Director of the FTC’s Bureau of Consumer Protection. “These companies violated their trust by making claims they just couldn’t prove.”
The Commission’s Complaints
According to the FTC’s complaints, the respondents claimed that their natural progesterone creams: 1) are effective in preventing, treating, or curing osteoporosis; 2) are effective in preventing or reducing the risk of estrogen-induced endometrial (uterine) cancer; and 3) do not increase the user’s risk of developing breast cancer and/or are effective in preventing or reducing the user’s risk of developing breast cancer. The complaints allege the respondents did not have substantiation for these claims and, in some cases, misrepresented that clinical testing proved the products were effective.
The products allegedly sold without proper health-claim substantiation include: ProBalance and ProBalance Plus transdermal creams; Elation Therapy Natural Progesterone Cream; Preserve Progesterone Cream; Progesta Care Plus; EST progesterone cream; Restored Balance progesterone cream; Serenity for Women Natural Progesterone Cream; Nature’s Precise Cream; Eternal Woman Progesterone Cream; and Pro-Gest Body Cream.
The Consent Orders
The consent orders announced today settle the FTC’s charges against the following individuals and organizations: 1) Lawrence A. Jordan and Stephanie L. Jordan, individually and doing business as (d/b/a) Springboard and Pro Health Labs of Spring Valley, California; 2) Elation Therapy, Inc., and Robert Rutledge, individually and as an officer of Elation Therapy, Inc., of Marietta, Georgia; 3) Merilou Barnekow, individually and d/b/a Women’s Menopause Health Center of Surfside Beach, Texas; 4) The Green Willow Tree LLC, and Robert Burns individually and as a manager and member of The Green Willow Tree, LLC of Asheville, North Carolina; 5) Health Science International, Inc., and David Martin, individually and as an officer of Health Science International, Inc., of Port Orange, Florida; and 6) Shelly Black, individually and d/b/a Progesterone Advocates Network of Trabuco Canyon, California.
Under the terms of the orders, the respondents are required to have competent and reliable scientific evidence substantiating claims about the health benefits, performance, efficacy, safety, or side effects of any dietary supplement, food, drug, device, or health-related service or program, including claims that progesterone products are effective in mitigating, treating, preventing, or curing any disease. In addition, the orders prevent the respondents from misrepresenting the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research. Finally, the orders contain record-keeping and notification provisions designed to ensure the respondents comply with their terms. The orders will expire in 20 years.
The charges against Herbs Nutrition Corporation and Syed M. Jafry, individually and as an officer of Herbs Nutrition Corporation of Torrance, California, have not been settled, and the case will be tried by an administrative law judge at the Commission.
Consumer Information
In the actions announced today, the FTC obtained all the relief necessary to protect consumers by focusing on some of the most egregious claims made by the online sellers of alternative HRT. The FTC staff is not aware of any competent and reliable scientific evidence to support claims that natural progesterone products are safe, or that they are effective in preventing osteoporosis, increasing bone density, or preventing, treating, or curing cancer, heart disease, or other diseases. When evaluating health-related claims for any product, it may be a good idea for consumers to talk to their primary care physician, pharmacist, or healthcare provider.
The Alternative HRT Web Surf
The FTC staff identified the respondents through an Internet search of Web sites advertising products that claimed they were natural alternatives to HRT and that they would prevent diseases such as cancer and osteoporosis. The FTC staff sent warning letters to 34 Web site operators informing them that they must have competent and reliable scientific evidence to support any health-related claims made for their products. The staff advised the marketers to revise or delete any false, misleading, or unsubstantiated claims.
The FTC’s letters noted that the staff was not aware of any competent and reliable scientific evidence to support claims that natural progesterone products are safe or are effective in preventing osteoporosis, increasing bone density, or preventing, treating, or curing cancer, heart disease, or other diseases. The U.S. Food and Drug Administration (FDA) sent letters to an additional 16 alternative HRT sellers, warning them that their business practices could be in violation of FDA law.
The FTC staff followed up with the online advertisers who received letters, and all except seven modified the claims on their Web sites. The Commission now has charged those seven sellers with violating the FTC Act, and has settled the charges against six of the seven sellers.
The Commission vote authorizing the filing of an administrative complaint against respondents Herbs Nutrition Corporation and Jafry was 5-0. The vote authorizing the filing of administrative complaints and consent orders settling the charges against the remaining respondents was 5-0. The consent orders will be subject to public comment for 30 days, beginning today and continuing through November 7, 2007, after which the Commission will consider whether to make them final. Comments should be send to: FTC Office of the Secretary, 600 Pennsylvania Ave., N.W., Washington, DC 20580.
NOTE: The Commission authorizes the filing of a complaint when it has “reason to believe” that the law has or is being violated, and it appears to the Commission that a proceeding is in the public interest. A complaint is not a finding or ruling that the defendants have actually violated the law.
NOTE: A consent agreement is for settlement purposes only and does not constitute an admission of a law violation. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of $11,000.
Copies of the Commission complaint and consent orders can be found as a link to this press release on the FTC’s Web site. The FTC works for the consumer to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, click: http://www.ftc.gov/ftc/complaint.shtm or call 1-877-382-4357. The FTC enters Internet, telemarketing, identity theft, and other fraud-related complaints into Consumer Sentinel, a secure, online database available to more than 1,600 civil and criminal law enforcement agencies in the U.S. and abroad. For free information on a variety of consumer topics, click http://ftc.gov/bcp/consumer.shtm.
MEDIA CONTACT:
Mitchell J. Katz, Office of Public Affairs 202-326-2161
STAFF CONTACTS:
Laura DeMartino Bureau of Consumer Protection 202-326-3030
FDA cracks down on custom-made hormones
By RANDOLPH E. SCHMID, AP Science Writer January 9, 2008
WASHINGTON - Government health officials on Wednesday began cracking down on Internet sales of custom-mixed hormones for menopausal women, a market born when doctors deemed prescription estrogen therapy too risky for many. But the Food and Drug Administration says these alternative hormone mixes are no safer, and told seven makers to stop selling them.
The FDA said it sent warning letters to the companies saying their claims about the "bio-identical hormone replacement therapy" or BHRT products are not supported by medical evidence and are considered false and misleading.
"We want to assure that Americans receive accurate information about the risks and benefits of drug therapies," Dr. Janet Woodcock, FDA's chief medical officer, said in a statement.
The agency said it is concerned that the claims for safety and effectiveness mislead patients, as well as doctors and other health care professionals.
Compounded drugs are not reviewed by the FDA for safety and effectiveness, and FDA encourages patients to use FDA-approved drugs whenever possible, the agency said.
The warning letters say the pharmacy operations violate federal law by making false and misleading claims about their hormone therapy drugs.
Following a 2002 study that found replacement hormones made by drug companies raised the risk of heart attacks, breast cancer and strokes, many women turned to the estrogen, progesterone and testosterone products sold by compounding pharmacies.
Medical researchers concluded in 2003 that hormone replacement pills should be taken only as a brief treatment to help women weather the worst symptoms of menopause.
The drug company Wyeth later complained to the FDA about the Internet sales of compounded products.
Aetna will stop paying for dubious hormone treatments {from our friends at Quackwatch.com}
Aetna has announced that as of October 1, 2007, it will no longer cover about 25 types of "bioidentical hormones" and compounded thyroid drugs. [Coverage policy changing for hormone, thyroid compounds. Aetna Office Link Updates 4(3):6, 2007] https://aetna.providerpreference.com/landing/New_England_OfficeLink_6_07.pdf Bioidentical hormones are often prescribed unnecessarily by practitioners who rely upon salivary hormone testing, which Aetna also criticizes. [Salivary hormone tests. Aetna Clinical Policy Bulletin 0606, Oct 17, 2006] http://www.aetna.com/cpb/medical/data/600_699/0608.html
Suzanne Somers sells bioidenticals. You decide!
Air Brsushed Suzanne Somers. She should be ashamed!
The "Bioidentical/Bioequivalent" Hormone Scam
Alastair H. MacLennan and David W. Sturdee
Climacteric 2006; 9:1-3
So-called ‘bioidentical or bioequivalent hormones’ are increasingly being sold direct to women on the internet or through laboratories and compounding chemists, who encourage patients to obtain prescriptions for these unregistered and unproven concoctions from their doctor. Gullible doctors are often writing prescriptions dictated by outside agencies that have purportedly assessed the woman’s hormonal needs through salivary hormone testing. Women are being falsely informed on multiple internet sites or through media advertisements in various ways that ‘Bioidentical hormone therapy has all of the good effects of HRT with none of the severe side-effects that have caused so many women looking for menopause relief to steer away from traditionally administered HRT.’ Most sites start with fear tactics and may falsely represent the true risks of pharmaceutical HRT and then state or infer that their pharmacy-mixed hormones have similar or greater benefits, with no risk or no mention of risk. Quite correctly, they say that hormone therapies are best tailored to the individual and her needs, but the pseudo science is that they claim that a woman’s clinical need can be calculated from her saliva.
In truth, there is no scientific evidence to back claims for ‘bioidentical hormones’ that they have any advantage over conventional therapies, but there is evidence that they may sometimes be dangerous1. So-called ‘bioidentical’ hormones are claimed to be synthesized from many of the same sources as traditional HRT, e.g. yams. The hormone made by the ‘bioidentical’ manufacturer is often claimed to be ‘natural’ and, in advertisements, it is inferred that the identical estradiol, produced by the regulated pharmaceutical industry from the same yam source, is somehow different and not natural.
Great play is often made of pharmaceutical estrogens produced from non-vegetable sources, e.g. equine estrogens, but there is little mention that these estrogens are mostly converted in the human into human estrogens. It should be clearly stated that there are no published peer-reviewed data to show that a single or multiple salivary hormone assays can accurately reflect the hormonal status or needs of a woman and, in particular, there has been no validation that they can be used to titrate hormone regimens to give an appropriate hormonal response. It is not been shown that hormonal blood levels are useful in adjusting hormonal therapies, and salivary levels also have not been correlated with clinical response. Most experienced clinicians realize that hormone regimens are best tailored by the clinical response and not by biochemistry reports.
The ‘bioidentical’ hormonal mixtures are compounded in buccal troches or transdermal creams and may contain estrogens (estrone, estradiol and estriol), progesterone, testosterone, dehydroepiandrosterone (DHEA), thyroxine, growth hormone and melatonin. Purveyors of these hormones use loopholes in some countries’ therapeutic goods regulations, where these hormones are either considered as complementary medicines (which are often poorly regulated) or where there are regulations that allow the importation of drugs that are not available in that country but are needed for a specific patient. In reality, the hormones are imported by compounding pharmacists before any patients are identified and, through various forms of advertising, women and doctors are attracted. Financial incentives are sometimes offered to doctors to prescribe the mixtures and to use laboratories, which claim without validation that they can effectively measure salivary hormones and thereby recommend the precise mixtures of hormones to be compounded to give the desired clinical effect.
The ‘bioidentical’ salesmen play on recent media hype about registered menopausal hormone therapies and the illusion that their hormones are somehow more ‘natural’ and therefore somehow safer than those synthesized by a pharmaceutical company. In reality, unlike the strict requirements for registered pharmaceutical products, the bioidentical products can be synthesized and imported without regulatory quality control evidence of purity, dosage, contamination, bioavailability, etc. They are compounded with other hormones and ingredients in local pharmacies without safety data concerning these combinations and doses and without adequate pharmacy audits of the compounding process.
They are sold without evidence of the pharmacokinetics, clinical effect, sideeffects and drug interactions of these particular hormonal regimens. Some of the individual hormones used such as DHEA have not been approved by therapeutic regulatory authorities and have no quality data to justify their clinical use. In 2001, the FDA analyzed a variety of 29 product samples from 12 compounding pharmacies and found that 34% of them failed one or more standard quality tests (
2).
Wren and colleagues have conducted one of very few pharmacokinetic studies of bioidentical hormones delivered in a buccal troche and assessed both plasma and salivary levels, with the conclusion that salivary levels were highly variable and their accuracy and value were uncertain for therapeutic monitoring of hormonal therapy(3). Wren and his colleagues also conducted a double-blind, randomized, controlled trial of transdermal progesterone cream, finding no clinical beneficial effect. Of greater concern, these authors found that this progesterone regimen had no measurable effect on the endometrium and thus would not suppress estrogen-induced endometrial proliferation(4). There have been anecdotal reports of endometrial cancers following the use of bioidentical hormonal regimens containing ‘natural’ estrogens and progesterone. Thus, there is great concern that progesterone given by buccal or transdermal routes, in conjunction with estrogen, is not proven to suppress the risk of endometrial cancer induced by estrogen therapy. If the estrogens used in 'bioidentical’ mixtures are the same and can reach bioequivalent serum levels, they are likely to have the same benefits as registered estrogens. However, they will also have the same risks. If the opposing progesterone used does not have a protective endometrial effect, it will have greater risks than conventional combined HRT.
The cost of the unproven ‘bioidentical hormones’ is usually several times greater than traditional menopausal hormone therapies and the patient often has to pay dearly for the salivary tests. Both the patient and her doctor may receive results of these assays from ‘hormone consultants’, whose qualifications are unknown, who have not seen the patient, and who give unvalidated interpretations of the results that they reflect abnormal adrenal, ovarian and/or thyroid function. In examples of these reports that we have seen, the ‘hormonal consultant’ advocates the precise hormonal mixtures and doses that the patient should obtain and the doctor should prescribe. This has huge medicolegal implications for the prescriber who takes the responsibility for the quality, risks and evidence for the use of this unregistered complementary and alternative therapy.
In a recent Climacteric Editorial, Breen outlined the ethical responsibilities for those advocating and prescribing complementary medicines (
5). The prescriber must inform the patient when a therapy is unproven, the patient must be fully informed of any risks associated with such therapy, access to proven therapies should not be denied, a second medical opinion should be offered if there are potential risks to an unproven and unconventional therapy, and doctors should not gain financially from the sale of these products.
Medical negligence could be claimed:
l
If you were unaware of the published risks of the hormones in your prescription;
l
If you have not fully informed your patient of these risks;
l
If you were unaware of known drug interactions for these products;
l
If you were unsure of the appropriate hormonal mixtures and doses you prescribed;
l
If there is no supporting peer-reviewed academic data for your therapeutic regimen;
l
If you had given the impression to the patient that ‘bioidentical hormones’ were safe.
There is some doubt that medical indemnity agencies will indemnify doctors if they prescribe unproven complementary products, especially if they have escaped any scrutiny by the relevant national therapeutic regulatory agency.
In Australia, the Australasian Menopause Society wrote to the medical indemnity agencies in Australia and could not obtain any clear assurance that their members would be covered for the prescription of such products. The four agencies that replied had many caveats about the adequacy of evidence for the product and the extent that the patient was informed about its proven risks and benefits, and would not guarantee cover. Therefore, the prescriber may be at personal financial risk if litigation ensued because an adverse event, e.g. thromboembolism, was claimed to have been precipitated by ‘bioidentical’ therapy. In some countries, a doctor must be fully indemnified to be registered to practice medicine. So, they may also risk their medical registration. One wonders why prescribers of bioidentical hormones take such risks!
In Australia and the USA, there has been a recent proliferation of compounding chemists who have taken advantage of postmenopausal women’s need for and anxiety about conventional HRT and the loopholes in current legislation in these countries. These compounding pharmacies are now manufacturing ‘bioidentical’ hormonal mixtures and delivery systems in such proportions that they have effectively become a large, inadequately regulated pharmaceutical industry. It is time for the international drug regulatory authorities to regulate this industry, which is based on false promise, pseudo science and pecuniary interest without responsibility for the interests and health of the consumer.
References
1. Boothby LA, Doering PL, Kipersztok S. Bioidentical hormone therapy: a review. Menopause 2004;11:356–67
2. Beasley D. Use of ‘‘bioidentical’’ female hormones questioned. Reuters Health Information, Oct 31, 2005
3. Wren BG, Day RO, McLachlan AJ, Williams KM. Pharmacokinetics of estradiol, progesterone, testosterone and dehydroepiandrosterone after transbuccal administration to
postmenopausal women. Climacteric 2003;6:104–11
4. Wren BG, Champion SM, Willets K, et al. Transdermal progesterone and its effects on vasomotor symptoms, blood lipid levels, bone metabolic markers, mood, and quality of life
for postmenopausal women. Menopause 2003;10:13–8
5. Breen KJ. Ethical issues in the use of complementary medicines. Climacteric 2003;6:268–72
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