Dr. Erika | Bioidentical Hormone Expert

NEWSWEEK'S ATTACK ON OPRAH WILL NOT HELP THE PUBLIC

This week's Newsweek cover story is a harsh and lengthy attack on Oprah and her ever-expanding health care advocacy choices. The article questions the legitimacy of her choices and points out that some of her doctors and “experts” are far out of the medical mainstream. 

I have never been on the Oprah Show, but last winter I was interviewed by Oprah's main doctor Mehmet Oz on his satellite radio show. Patients and e-mails flooded my office for months. This spring I was quoted in Oprah’s magazine as they interviewed one of my patients about bioidentical hormones. I learned first hand the power of Oprah and the success she brings to everyone she touches.

At times while watching her shows and reading about her choices of experts I wondered about the lack of balance. I even wrote to her producers when I realized by watching her that her thyroid was badly treated and I knew she was not getting good advice.

When she talked about bioidentical hormones I was thrilled. Her choice of experts and spokeswoman for the hormones, Suzanne Somers, left me cold. But it was Oprah who opened the door to bringing bioidenticals to the mainstream so I applauded her effort. When I gave my lecture on bioidentical hormones at Harvard in February 2, 2009, the first slide I showed was the one of Oprah with Suzanne Somers.

I asked the chairman of the department of ob-gyn, Isaac Schiff, MD and the rest of the physicians in the audience, “ How come Suzanne Somers and Oprah are the ones to teach the public about bioidentical hormones? What has the medical profession done with the information of the Women’s Health Initiative study?  Nine years later and women are still suffering and the medical establishment has not stepped up to the plate to help women find safe solutions to menopausal symptoms. Why are bioidentical hormones still controversial?” They had no answers.

Oprah did. She did what no conventional media or conventional medicine has done. She has stepped up to the plate. She has given the public the missing information. Instead of indoctrinating us with the party line, Oprah has opened the door to other options. And the public has spoken. Oprah is their leader, not the American Medical Association.

Granted, Oprah may not have always chosen the best “experts” or figured how to provide a balanced view of their opinions. But then, who does? At least she has had the courage to bring to the public new ways of looking at health and has sparked interest in options that others would like kept under wraps. Don’t let the naysayers stop progress! 

Is Gardasil Reall Protecting Our Daughters?

Gardasil, the controversial cervical cancer vaccine that is heavily marketed to young girls and women through schools, government agencies, media and physicians, is again coming under scrutiny amid thousands of complaints linking it to health problems, CNN reported today.

The vaccine has been the subject of 7,802 "adverse event" reports, including 18 deaths and two law suits, from the time the Food and Drug Administration approved its use two years ago, according to the Centers for Disease Control and Prevention.

When Gardasil first came out in 2006, I wrote two blogs questioning its credibility and its safety.

- http://www.drerika.com/blog?action=viewBlog&blogID=-671659212713105333
- http://www.drerika.com/blog?action=viewBlog&blogID=-797119734004008104

Sadly, my concerns are all too real.

Merck estimates more than eight million girls and young women in the U.S. have now received the vaccine, thanks to an extraordinary marketing blitz in which the company pressured state governments to make its use mandatory for school attendance.

Merck claims Gardasil prevents cancer caused by a few strains of the human papilloma virus, known as HPV -- a sexually transmitted virus, as common as the common cold that may cause cervical cancer in a relatively small percentage of infected women.

When asked about the adverse reactions and deaths, Merck insists there is no clear connection.

This response reminds me of the analogy to Thalidomide in the 1960s when babies born with flippers instead of limbs were also not considered proof of the connection between pregnant women taking thalidomide before giving birth to these poor babies.

The situation also reminds me of a 24 year old woman in my practice who got breast cancer after being on BC pills for 8 years. When I called the manufacturer of the BC pills to report the incident, the medical director bluntly told me I could not make the connection thus he would not take the report.

Finally, a glimpse at the FDA records on HPV vaccine clearly states that the evaluation of the vaccine's efficacy and safety will not be completed until September 30, 2009. So why have 8 million of our daughters been immunized and what is waiting for their babies when they become mothers?

Time has come to take care of the patient not the bottom line.

We need to make sure our voices are heard and we protect our daughters by not following blindly the marketing policies of a drug company out to make money off our fears or by being intimidated by doctors who get their information from the drug reps at their doorstep.

Circulate this Blog and let everyone know they need more information and less manipulation.

Beware doctors with hidden agenda$

Readers of my blog are well aware of the dangers that arise when doctors and drug companies serve each other's interest and put profits ahead of patients. Here's another glaring example: World-renowned Harvard child psychiatrist Dr. Joseph Biederman , whose work has helped fuel an explosion in the use of powerful antipsychotic medicines in children, earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007.

 The full extent of the payments only came to light recently when a congressional committee forced him to confess.

Unfortunately the problem is that Dr. Biederman is one of the most influential researchers in child psychiatry.

His work has helped fuel a controversial and incredible 40-fold increase in the diagnosis of pediatric bipolar disorder and, as a happy and not very surprising consequence for his drug sponsors, an astronomic rise in the use of antipsychotic medicines in children.

Oddly many in the medical community are asking belatedly whether this drug money influenced his findings. Why wasn't the question asked before?

Sadly, Dr Biederman is not alone in this healthcare jungle which abounds with doctors with hidden agendas. He is probably only the tip of the iceberg. All you have to do is watch the morning shows on network TV. Notice the majority of the ads are for drugs. Then watch how all too often the medical experts on the show recommend a path that leads to drug treatments benefitting the sponsors. And shockingly alternatives are nowhere to be found. Conflict or just oversight? You be the judge.

After 30+ years of taking care of patients I finally understand that doctors come in two categories:

 - Those who are honest and true to their Hippocratic Oath and are dedicated to serving only their patients.

- Those who work for a different master - the drug companies, the health insurers, the fear of malpractice, anything but your best interest.

Run away from the second group. If you stay, they will harm you. If you stop going to them, being intimidated by their bullying and fear mongering, eventually they will disappear and along with their extinction, we will all benefit from a new health care system that will emerge.

You can identify the doctors who don't work to serve you very easily. When you bring information to them that does not mesh with their masters' marketing message, they will push back. They don't listen or respect your opinion and they always are very sure of themselves and the information they dispense. They are not open to your questions and they do not acknowledge you as a person. Enough said.

Doctors in the first category, those who are the doctors who care and are in practice to serve you listen to you, respect your opinion, are open to information you bring to them and are always willing to learn. And finally but very importantly when they don't know something they will tell you so. They aren't all knowing. They are humble and caring. Stay with that doctor and I bet your outcome will always be better than you expected.

Ghostwriting Scientific Articles Added to the Job Description of Big Pharma

Some drug companies will stop at nothing to push their products on an unsuspecting public, even when they kill people.

Next time you read about glowing research on a new drug, remember this:

Merck has just been exposed for writing its own research studies for its blockbuster drug Vioxx, then getting top doctors to put their names on the studies as if they'd actually done them.

This way Merck managed to dupe prestigious medical journals into publishing their pseudo science. Next, the articles were picked up as gospel by the mainstream media and the treatment recommendation followed by unsuspecting, gullible physicians. Finally, we the public walked out of the doctor's office with a prescription for "the best and newest" anti-inflammatory drug, Vioxx. How crazy is that?

I wish I could say I was shocked by this revelation, but readers of my blog are well aware that I keep telling you real and sad stories of how too many drug companies have long abandoned the public in favor of big profits. The Food and Drug Administration, the federal agency mandated to protect the public from the greed and excess of the drug companies, has instead climbed into bed with them.

Vioxx was a best-selling drug before Merck took it off the market in 2004 over evidence linking it to heart attacks (which by the way was hidden from the medical community and consumers for at least two years). Last fall, the company agreed to a $4.85 billion settlement for tens of thousands of lawsuits filed by harmed patients or their families.

The latest issue of the Journal of the American Medical Association contains a crucial article that addresses newly uncovered documents from the Vioxx lawsuits which provide an unprecedented look into the practice of ghostwriting medical research studies that are then published in academic journals by the pharmaceutical industry.

The article cited one draft of a Vioxx research study that was still in want of a big-name researcher, identifying the lead writer only as "External author?"

The lead author of the JAMA article, Dr. Joseph S. Ross of the Mount Sinai School of Medicine in New York, said the Merck documents raised broad questions about the validity of much of the drug industry's published research, because the ghostwriting practice appears to be widespread.

"It almost calls into question all legitimate research that's been conducted by the pharmaceutical industry with the academic physician," he said.

Dr. Ross deserves much praise for bringing this scandalous state of affairs to the public's attention.

Vioxx was a financial success for Merck - and a lethal drug for patients who took it. Unfortunately the drugs massive success came through Merck's use of its financial might to overwhelm the FDA (keep them in the dark about the dangers), inundate the public with costly TV and print advertising (based on less than trustworthy research) and duping doctors into believing the value of the drug with its questionable research reports.

The Vioxx and Merck story are only an example of what happens all too often in our present drug company profits dominated environment.

There's only one way to change this sorry state of affairs - but don't expect drug companies to change their ways voluntarily.

The solution and protection must come from doctors and patients who must adopt a new attitude - one that leads to empowerment, mutual respect and honesty.

Every time a budding doctor takes the Hippocratic Oath, he/she promises to do no harm to patients. The doctors who prescribed Vioxx did harm their patients because they blindly relied upon claims made by Merck that turned out to be false. It is the doctor's responsibility to question the drug companies. I don't care where the information comes from and who sells it to me, I know one thing only: the doctor's job is to serve and protect the patient.

Many patients harmed themselves by unquestioningly taking their doctor's prescription, many because they believed the TV commercials about Vioxx represented the truth.

The Oath to do no harm should not only be taken by doctors. Each and every one of us must take our own Oath of empowerment and refusal to be intimidated and victimized. We must become our own advocates and stop accepting blindly medications or treatments handed out to us without question or consideration of the relationship we have with the doctor.

Once the doctors start serving the patients first and the patients stop allowing themselves to be intimidated and bullied, we will put an end to the greed and dishonesty that is crippling healthcare and create a safe and healthy environment for ourselves and our children.

National set of physician standards is an insult to every doctor and patient in this country

The medical establishment has climbed into bed with the nation's health insurers and agreed to a "national set of standards" for the public to measure physician performance.

Memo to the public: Don't expect this to be the solution to your medical problems.

Mainstream medicine and the insurers are equally responsible for the expensive mediocrity and lack of care that defines today's healthcare shambles. These two groups coming together are not going to fix anything, they are the ones that created much of the misfortune we now define as so-called healthcare.

National standards won't motivate doctors to provide any better care nor help the public become healthier. What's needed is patient advocacy and education to help the public navigate this enormous and bewildering system and help doctors learn to become more caring and service oriented to deliver the best possible outcome.

Fact is patients today are confused by the rapid changes in care and ever increasing treatment options, by reckless pharmaceutical marketing aimed directly at them on TV and print, and by the vast array of unverifiable medical information swamping the internet.

No one is stepping forward to help the public and they no longer trust conventional medical treatments to be in their best interests. No wonder there is a growing trend towards alternative and unconventional medical advice and treatments. Not that these treatments hold any more promise or proof of efficacy.

Applying "national standards" to a field so complex and diverse is an insult to every doctor and patient in this country. It will serve neither constituency, but it will certainly keep the machine that is our present healthcare mess spinning.

"Physician report cards will not be based on cost alone," claims Dr. Nancy Nielsen, the president-elect of the American Medical Association who, along with the American College of Surgeons, agreed to this insane deal with the insurers.

It's not clear what factors will be used to determine these so-called national standards. In the past, doctors complained that insurers were obsessed by costs and ignored the quality of care provided and that rankings supplied to patients were inaccurate or meaningless. Why hasn't anyone listened to the doctors then?

By the way, the AMA does not enjoy a stellar reputation when it comes to protecting the best interests of doctors or patients. This newest sham won't help their predicament.

The group represents barely 19% of the nation's practicing physicians. In the past, it has been accused of inflating medical costs in the U.S. by limiting the supply of physicians to insure them higher pay. It did this by limiting the size of medical schools through its control by retired members of state licensing boards. Now, the AMA is in the business of making money off the doctors while representing other interest groups.

You might be interested to know the AMA derives a significant portion of its income from selling physician prescribing data to pharmaceutical companies, claiming $33 million in revenue in 2005 from this practice. Not to mention how much pharma monies goes into the AMA's coffers just to support its mere existence.

Doctors - and patients - should not look to discredited groups like this to help them improve the stare of our health care.
The answer lies in empowerment through education and patient advocacy and definitely not sponsored by the drug companies or their representatives.

People don't belong in the doctor's offices, testing facilities or hospitals. They belong in their own lives.

Doctors are kept in the dark for two years about dangers of Vytorin as $200 million marketing campaign continues on TV

The peril of mass marketing prescription drugs to the public was evident again this weekend when the New England Journal of Medicine reported (3/30/08) that two frequently-prescribed cholesterol-lowering drugs, Vytorin and Zetia, may not work and should be used only as a last resort.

There's a lesson here every physician and every patient should pay attention to.

Vytorin and Zetia's use has soared in the United States amid their ubiquitous, $200 million TV and print marketing blitz. (Vytorin ad on Youtube). In Canada, where advertising drugs to consumers is not allowed, sales are four times lower. The medications are major profit makers for their manufacturers, Merck and Schering-Plough - worldwide sales totaled $5 billion last year.

Doctors at a major cardiology conference in Chicago were just shown for the first time the full results of a two-year clinical trial that demonstrated that the drugs failed to slow, and might have even sped up, the growth of fatty plaques in the arteries. Growth of those plaques is closely correlated with heart attacks and strokes.

Congress and state officials in New York have been investigating why these results were hidden for nearly two years after the study ended. Appallingly, despite these findings, Merck and Schering-Plough said they would continue to promote these medications as first-line treatments for high cholesterol.

Dr. John Kastelein, the Dutch scientist who led the study, said the results show the drug had "no result -- zilch. In no subgroup, in no segment, was there any added benefit in terms of reducing plaque."

It's time for responsible members of the medical community to stand up to this marketing madness. The public unknowingly is exposed to compelling advertising for powerful prescription drugs be it on TV or in magazines without the benefit of honest medical information or guidance from a caring and well informed physician. This situation only benefits the bottom line of the pharmaceutical manufacturer of the drugs and jeopardizes the health and wellbeing of the patient as well as bringing into question the role of the doctor-patient relationship.

Doctors need access to information about these drugs in a timely manner. The fact that the results in this case were kept secret by the drug companies for two years is a disgrace and unfortunately not a unique occurrence in our present drug company run health care system.

Doctors need to remember the oath they took to protect their patients and serve them and patients need to take a similar oath of not allowing themselves to become victims of ruthless marketing and intimidation by parties interested solely in financial gain.

Women Must Say No to Merck's Latest Greedy Gambit

Merck has flexed his financial muscle and persuaded the Food and Drug Administration to fast track approval of its dubious cervical cancer vaccine Gardasil for women ages 27 to 45.

Bloomberg News reported this disturbing announcement (March 20). Here's all you need to know from the Bloomberg report to understand why women's health has become a national scandal.

- "Gardasil, already approved for females ages 9 to 26, is one of Merck's top-selling
products with $1.5 billion in sales last year."

- "Use among older women may generate an additional $1 billion in annual sales for
Merck."

- "Merck is counting on Gardasil to replace revenue lost from products losing patent
protection."

Readers of this blog are familiar with the disgraceful story of Gardasil, a drug that was approved by the FDA based on tests conducted by Merck on teenagers in remote, poverty-stricken African villages.

In February last year I wrote: "Gardasil is an act of aggression against our daughters who are becoming victims of pharmaceutical greed. It has only been tested for five years on possibly as low as 100,000 ten year old girls in Africa. No one knows what will happen to those girls or our girls in the five, 10 or 20 years after the vaccine has been administered. The only science here is the real live testing about to be done on our daughters, who are technically, like the African ten year olds, the guinea pigs. Remember Lyme vaccine? What happened to that cure-all? It killed a few people and was quickly taken off the market.''

Since then the public interest group Judicial Watch has just reported 1600 cases of serious adverse events in patients who received Gardasil, including 11deaths.

Now this drug is to be inflicted on older women. How many of them get cancer from HPV? Not many. How many NEED to be vaccinated with a vaccine that has already killed young women, has been minimally tested and is purely a vehicle to make money for Merck?

Yet the craven bureaucrats at the FDA, whose job is to protect the public rather than the drug companies, have agreed to cut the approval process for Gardasil from 10 months to six months.

It's time for women to learn to say NO and for doctors to stop being the drug companies lapdogs.

Wyeth figures out again how to profit from women's woes, with FDA's approval

Here's some news that will make us all depressed - Wyeth has won FDA approval for its new antidepressant Pristiq. Yes, the same FDA who has just told us "bioidentical hormones" don't exist, the same FDA who has told compounding pharmacists to stop using Estriol, the mildest of estrogens when it helped hundreds of thousands of women with menopausal symptoms. Yes, the FDA whose mandate is to protect the public has spoken again. This time, it didn't take one of its hundreds of FDA approved dangerous flops off the market, this time it has added yet another antidepressant to an already endless list of drugs that don't' work to the market.

Unfortunately this is proof yet again that the FDA is more anxious to protect Wyeth's profits than the wellbeing of the American public.

This is a particularly ominous development for women - Wyeth is also asking the FDA to approve Pristiq as a drug to reduce hot flashes in menopause.

Pristiq is the successor to Effexor XR, whose patent expires in two years. Sales of Effexor last year were $3.8 billion. By the way, Effexor is not exactly a great drug either. Just check my blog on the topic and read about its side-effects and disastrous record when it comes to attempting to get off it. But let me get back to what matters.

The new drug provides a lucrative new revenue stream for Wyeth. How lucrative? Well, on the day it won FDA approval (February 29) Wyeth stock soared 2.5% while the rest of Wall St tumbled 315 points.

Did I mention any benefits to patients? I would, if I could think of any. One thing I'd like to ask the FDA and Wyeth is how many people (women) have taken this drug for how long before it got through the approval process? And by the way, did anyone have any adverse reactions we might consider serious enough to skip the drug altogether?

The prospect of Pristiq being approved for menopause is truly disturbing and proves the FDA has relinquished any pretence of protecting women. Treating menopause with anti-depressants is ineffective and dangerous. If women are depressed during menopause it is because their hormones are depleted and most conventional doctors discard their symptoms and tell them they are just getting old and should just get over it and go away.

The sensible and caring way to deal with the problems of menopause is to help women understand what happened to their bodies, how their diets affect the way they feel, how exercise improves the symptoms, how stress management helps them get the sleep they need, how supplementing their hormones with bioidentical hormones can help them get their lives back on track and enlighten the world with the wisdom they acquired along the way.

The solution is not going to be found in giving them another drug to become dependent upon.

Instead, the FDA is making it harder for women to find safe, sensible alternatives.

You'd think they'd done enough favors for Wyeth.

Supreme Court will side with big pharma over unsafe drugs

The Food and Drug Administration has come under increasing criticism from independent group who say it is incapable of protecting the country against unsafe drugs.

You only have to look at the debacle over hormone replacement therapy and the growing abuse of prescription drugs to see how true that is.

Now the U.S. Supreme Court has weighed in on the issue and - inexplicably - it has chosen to protect FDA bureaucrats rather than the public.

The court issued a decision (February 20) that will limit lawsuits by patients who have been injured by medical devices approved by the FDA. The court has signaled that it intends to provide a liability shield to drug manufacturers, too.

It comes as such respect organizations as The Institute of Medicine, the Government Accountability Office and the F.D.A.'s own science board have all issued reports concluding that poor management and scientific inadequacies have made the FDA incapable of protecting the country.

David Vladeck, a professor at Georgetown University Law Center, told the New York Times that the public is facing the worst of both worlds: a government health agency that cannot protect them and rules that block them from winning compensation when injured.

The fact is that the pharmaceutical industry has overwhelmed the FDA and most of the decision-makers in Washington, D.C. with its vast, no-expense-spared army of lobbyists. We see the results every day:

• A tidal-wave of TV commercials encouraging the use and abuse of powerful prescription medications, from anti-depressants to Ambien to Viagra. The result? Suicide is on the increase among middle-aged women - up 31 per cent from 1999 to 2004.
• The chaos and confusion after the 2002 Women's Health Initiative study that linked FDA-approved hormone replacement therapy to cancer, strokes and heart attacks. Instead of exploring safer alternative therapies, the FDA left the products on the market and never addressed their nepharious effects on millions of women.
• The decision to go after compounding pharmacies and ban the use of estriol - moves that makes no sense given the vast medical literature available on the subject and can only be explained as doing the bidding for big pharma which wants to crush the safer and more effective bioidenticals that hold no patent and thus no financial gain for big pharma.

We are in a time of crisis. In an election year, we need to look long and hard at what we want our future to look like. Do we want to continue being intimidated, victimized and heavily medicated? Or do we want to develop a system that represents the individual's best interest, health and strength regardless what the cost to big pharma or inept government agencies?

Coalition of Doctors Condemn FDA Decision to Deny Women Access to Bioidentical Hormones

A coalition of gynecologists, internists, allergists, ER physicians and general practitioners responsible for treating thousands of women today criticized the Food and Drug Administration (FDA) for taking action that threatens to deny hundreds of thousands of women access to customized medications they take for symptoms of menopause.

The FDA last week announced that the hormone estriol can no longer be used in estrogen medications customized for women by compounding pharmacies.  Estriol is a component of 90 percent or more of these customized preparations.

The FDA action is in response to a “citizen petition” filed by the giant drug maker Wyeth Pharmaceuticals.  Wyeth is the maker of Premarin and Prempro, two hormone treatments for women that have been linked to cancer, heart disease and stroke by the Women’s Health Initiative, NIH study.  Millions of women have discontinued taking Wyeth’s hormone products as a result of the WHI study, which was halted because of the serious health risks that were discovered in 2002.

“The FDA has succumbed to pressure from Wyeth in its attempt to clear the market of safer alternatives to its unsafe products,” said Erika Schwartz, M.D., a co-founder of BHI,  the Bioidentical Hormone Initiative (www.bioidenticalhormoneinitiative.org), a not-for-profit medical organization comprised of conventionally trained, practicing physicians who have successfully treated patients with bioidentical hormones for years.   “The FDA should protect the interest of women, not the profits of Wyeth.”

Estriol has been used by women for decades as a component of customized estrogen hormone drugs, most commonly known as Biest and Triest.  It occurs naturally in the human body and, according to the FDA, has never been associated with adverse events or other health and safety issues.  Estriol is also in a phase II/III clinical trial pending FDA approval for treating women with Multiple Sclerosis (MS).  It is approved for use and widely used in Europe and is a component of medications that have been commercially available in the U.S.

“There is no evidence that anyone has been harmed by estriol,” said Kent Holtorf, M.D., also a co-founder of BHI.  “The FDA has even admitted that safety concerns are not the reason behind their decision to try to remove estriol from the market.  Instead, they are responding to Wyeth’s blatant attempt to remove medicines that provide an alternative to their flawed horse hormones that are foreign to a woman’s body.”

“FDA’s actions are clearly misguided,” said David Brownstein, M.D., another founder of BHI.  “They have no legitimate reason or even the legal authority to limit a licensed physician’s use of a safe and effective bioidentical hormone.  There are numerous positive studies and countless successful outcomes with estrogen treatments containing estriol.”

The FDA claims that it is taking estriol off the market because it is not a component of any FDA approved drug, despite the fact that the hormone has been used for decades without problems.  Estriol has a long standing United States Pharmacopoeia monograph, an accepted standard for drug ingredients absent significant health risks.  Other common drugs that are not components of FDA approved drugs include aspirin. 

“There are no legitimate medical, scientific or legal reasons for the FDA to take this action,” said Dr. Schwartz.  “It would require countless women to return to their doctors and alter the medications they have used both safely and effectively for years.  If the FDA has its way, since estriol is available in Europe, a woman will need a passport, not a prescription to get her medication.”

The citizen petition filed by Wyeth with the FDA requested that estriol be removed from the market, along with other requests to remove customized medications that compete with their flawed products.  The petition created a tremendous backlash from women, doctors and pharmacists.  Over 77,000 comments, a near record, were filed with the FDA in response to the petition, all but a handful opposing Wyeth’s request.

“The few comments in support of the Wyeth petition were filed mostly by organizations with substantial financial ties to Wyeth,” said Dr. Schwartz.  “The FDA has chosen to protect Wyeth’s wealth rather than women’s health.  This is a shameful act for this agency to take.”

For more information on the Bioidentical Hormone Initiative, visit www.bioidenticalhormoneinitiative.org.