Sunday, November 4, 2012

The Boy Who Cried Wulf



The first article was posted as a blog at the American Nurse Today website. You can access the article here: http://www.americannursetoday.com/BlogView.aspx?bl=9012&bp=11776. The rebuttal to this article is printed below.

Bioidentical Hormones And Compounding Drug Deaths
Written by WULF H UTIAN MB BCh, PhD, DSc(Med), FRCOG, FACOG, FICS 10/19/2012 

The current tragic situation regarding contaminated compounded steroid injections causing stroke and death should alert women to the danger of using mass produced compounded bioidentical hormones as a menopause therapy.



ARE COMPOUNDED BIOIDENTICAL HORMONES REALLY SAFE?
The concept of bioidentical hormones, popularized by the likes of Suzanne Somers and Oprah Winfrey, has created real confusion. While the term has been used to refer to many well-tested, regulatory (FDA) approved, brand-name HT products containing hormones chemically identical to hormones produced by women (primarily in the ovaries), such as estradiol or progesterone, in the wider medical market it has assumed a different meaning. It is most often used to prescribe custom-made HT formulations (called “bioidentical HT”, or BHT) that are compounded for an individual according to a healthcare provider’s prescription.

It cannot be adequately emphasized that the FDA has not tested these products for efficacy or safety, and they are not approved by any regulatory agency. Indeed, safety information is not consistently provided to women along with their prescription, as is required by the FDA with commercially available HT products (the patient package insert). Moreover, batch standardization and purity may be uncertain (is this month’s prescription identical to last month’s?).

The FDA has actually sample-tested products from some compounding pharmacies and found unapproved contaminants, dosing errors, and other problems. As a result the FDA ruled that compounding pharmacies have made claims about the safety and effectiveness of BHT that is unsupported by clinical trial data and therefore considered to be false and misleading. The FDA has also stated that there is no scientific basis for using saliva testing to adjust hormone levels.

Much of the motivation behind this industry is explained in one word – PROFIT. Indeed the cost of the medications to women could be an issue. Medical insurance companies view many compounded products as experimental drugs and will not cover the cost.

MEDICO-LEGAL RISKS FOR PHYSICIANS AND NURSES
The prescribing of compounded drugs involves the triad of patient, physician/nurse prescriber, and compounding pharmacy. When prescribing an FDA-approved drug according to acceptable indications, in the event of an adverse outcome the nurse/physician is invariably indemnified by the FDA approval process and background support of a major pharmaceutical company, thus unlikely to face personal liability.

Compounders, unlike with FDA-approved products, are not required to provide a patient package insert listing risks and benefits, and their marketing invariably has minimized possibility of risks. Consequently, prescribers of compounded products would be personally exposed should there be an adverse event as a result of administering a product for which neither the prescriber or compounder can prove to have been pure and free of active contaminants, of correct dose, sterile etc. Providers should also be aware that the liability for using a non-FDA-approved drug can be significant, and possible negative consequences can include the invalidation of their malpractice insurance, personal liability, and possible criminal prosecution.

You can immunize yourself to a large extent against malpractice exposure. The simple and direct approach would be to only prescribe FDA-approved products.

Hopefully the extent of the current compounding drug tragedy can be contained.

The bottom line is that for virtually all women with indications for therapy, FDA-approved HT will provide appropriate “bioidentical” therapy without the risks and cost of custom compounded preparations.

Simply put, buyers beware!

Have a great week,
Wulf Utian MD PhD DSc



The Boy Who Cried Wulf


(This is a rebuttal to Dr. Wulf Utian’s blog on the American Nurse Today website reprinted above.  This post was co-written by myself and my colleague Dr. Erika Schwartz.)

It is important to state that compounded medications are ubiquitous in our health care system. Intravenous therapies, pain medications, chemotherapeutic agents, asthma medications, and even orange flavored antibiotics are all created by compounding pharmacies across the country. Our health care system could not function without the expertise of compounding pharmacies.

“The current tragic situation regarding contaminated, compounded steroid injections causing stroke and death should alert women to the danger of using mass produced compounded bioidentical hormones as a menopause therapy.” That quote was part of a blog written by Wulf Utian, M.D., founder of the North American Menopause Society.

Dr. Utian got one thing right; it is a tragic situation that occurred with the contaminated steroids causing meningitis and death. The pharmacy responsible for this tragedy, the same as any FDA approved drug that causes pain and suffering to patients, should be thoroughly investigated and, if necessary, prosecuted. However, to disparage all compounding pharmacies for the actions of one is as ridiculous as blaming all drug companies for one bad drug. Dr. Utian’s comments remind us of the hormone debacle he started in 2002 which, to this day, has left millions of women and their doctors confused and full of unjustified fears.  Dr. Utian claimed that bioidentical hormones had the same adverse effects that synthetic hormones caused.  This has never been shown to be true as bioidentical hormones have an impeccable safety record.  It reminds us of the nursery rhyme about the boy who continually cried wolf.

Unfortunately, there was nothing else constructive to Dr. Utian's vitriolic blog.

His sole purpose was to use this particular incident to further intimidate and confuse prescribers and users of compounded bioidentical hormones into fearing that all compounding pharmacies are providing dangerous, unregulated products. Utian, who appears to function as a pharmaceutical spokesperson rather than a patient advocate, would have you believe that compounding pharmacies are rogue businesses. His claims are blatantly false.

Drug manufacturers make FDA-approved prescription medications for mass markets. In contrast, compounding pharmacies make individualized drugs when the patient's needs can’t be met by commercially available medications. In fact, compounding pharmacists have been mixing drugs with an excellent track record of safety and effectiveness long before the advent of the age of mass-produced pharmaceuticals.

All pharmacies are licensed and regulated at the state level by pharmacy boards. USP is standard in pharmaceutical and compounding pharmacies. National practice standards are established by the Pharmacy Compounding Accrediting Board (PCAB). Compounding pharmacies are strictly regulated at the state level using the same active ingredients in their compounds as FDA-approved drugs available at your local pharmacies.

"...the FDA has not tested {the products used by compounding pharmacies} for efficacy or safety, and {these products} are not approved by any regulatory agency,” stated Dr. Utian.

The fact is that bioidentical hormone ingredients (e.g., estradiol, progesterone, testosterone, thyroid), used by compounding pharmacies, are purchased from suppliers that are registered and inspected by the FDA. Most compounding pharmacies purchase their raw materials from the Professional Compounding Centers of America (PCCA). PCCA purchases their materials though FDA-registered suppliers and verifies their potency through the same testing procedures that pharmaceutical companies use.

Dr. Utian claims the motivation behind the compounding pharmacy industry is “…explained in one word-PROFIT.” Certainly Dr. Utian, who seems to speak for pharmaceutical companies and has even a scholarship in his name paid for by Pfizer, understands the word profit very well. Is there a distinction between profit made by Big Pharma or a compounding pharmacy? Yes, Big Pharma makes more profit and produces drugs that are responsible for hundreds of thousands of deaths per year.

In fact, pharmaceutical drugs have been shown to be the third or fourth most common cause of death in the US.(1) The number of deaths from compounded medicines pales in comparison to the number of deaths caused by prescription medications. As we have previously stated, any medication-related death should be investigated and prosecuted to the full extent of the law.

Dr. Utian uses intimidation tactics claiming that doctors who use compounded medications are exposing themselves to increased malpractice risk and should stop using these items. This would include bioidentical hormones. For those of us who rely on compounded medications to meet the unique needs of our patients, the outcome of this type of gross intimidation would be to provide suboptimal care and become doctors who only care about malpractice and not the patients.

We denounce this suggestion and blatant affront to good medical practice.

Together, we have used compounded, bioidentical hormones and other compounded medications in our medical practice for over 40 years in tens of thousands of patients. We work closely with our compounding pharmacists and find their skill invaluable and supportive of individualized patient care. We have been writing and teaching doctors and patients about the effectiveness of compounded, bioidentical hormones for many years.

We strongly believe Dr. Utian would do better to focus his energy on helping the FDA figure out why FDA-approved prescription drugs are the third or fourth leading cause of death in the United States.

(1): JAMA. 4.15.98. 279. N. 15. P. 1200-6. This article can be accessed here: http://jama.jamanetwork.com/article.aspx?articleid=187436

David Brownstein, M.D.
Erika Schwartz M.D.

Drs. Schwartz and Brownstein are founding members of the Bioidenticalhormoneinitiative.org that presently has over 1,000 professional members.

David Brownstein, M.D.
5821 W. Maple Rd. Ste. 192
West Bloomfield, MI 48323
www.drbrownstein.com
O:  (248) 851-1600
F:  (248) 851-0421


Erika Schwartz MD,PC
www.DrErika.com
200 West 57th St
Suite 502
New York, NY 10019
O. 212-873-3420
F. 212-937-2279

Dr. Brownstein's book, The Miracle of Natural Hormones describes how natural , bioidentical hormones can be safely used. More information can be found at the link below.


2 Comments:

  • At November 5, 2012 at 6:28 AM , Anonymous Anonymous said...

    Yes, as an ICU RN, I can assure you that if you are a patient in a conventional hospital you are likely receiving compounded medications. Many hospitals lease out their complex IV fluid preparation to off-site, independent, compounding pharmacies. Also, treatment paradigms that have years of research backing them are not always FDA approved. Years of peer-reviewed endocrinology literature tells us that metformin can help women with PCOS conceive and remain healthier; however, this is not an FDA approved use of the drug. Whether you choose to put metformin in your body or not, my point is that we wait for the FDA at our own peril. Also, last I knew, the decision makers at the FDA were not exactly free from the influence of profit.

     
  • At November 5, 2012 at 7:38 PM , Anonymous Dr. Cheryl Perlis said...

    Thank you for taking the time to provide this outstanding rebuttal. It is a shame that more time is not spent helping patient's feel better, instead of attempting time and time again to negate the benefits of bioidentical hormones. You would think the sole purpose of this country is to keep patient's alive in disease states. A very sad situation for physicians who can not see "outside the box".

     

Post a Comment

Subscribe to Post Comments [Atom]

<< Home