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Bioidentical Hormone Therapy: Whats the Harm


... to talk about this subject without talking about the medical profession itself ... Not a scientific term, and no uniform definition in any medical dictionary ... – PowerPoint PPT presentation

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Title: Bioidentical Hormone Therapy: Whats the Harm

Bio-identical Hormone Therapy Whats the Harm?
  • Bruce Patsner, M.D., J.D.
  • Professor, Health Law Policy Institute,
    University of Houston Law Center
  • NAMS Annual Meeting September 26, 2008

  • The views expressed in this presentation are
    those of the author only. All information is in
    the public domain.
  • My views do not represent those of the University
    of Houston Law Center, The United States Food and
    Drug Administration, or any other government

Putting Bio-identical Hormone Therapy (BHT) in
  • BHT is a major issue at NAMS and every ACOG
    meeting every year
  • There is NO WAY to talk about this subject
    without talking about the medical profession
  • Are there problems with BHT?
  • If so, what are the solutions?

Some Basic Definitions
  • Bio-identical no set definition
  • Natural neither artificial nor pathologic
  • Pharmacy compounding defined by both FDA and
    Pharmacy industry at core is the triad
  • New drug defined by 1938 FDCA

What Are Bio-identicals?
  • Not a scientific term, and no uniform definition
    in any medical dictionary
  • Molecularly very similar or identical to
    endogenous hormones plant-derived from soybean
    or yam
  • Individualized exact doses to replicate
    homeostatic hormone levels of Estrogen,
    Progesterone, Testosterone
  • Dosage is adjusted according to salivary or blood
    hormone levels, unlike commercial HR which is
    adjusted based on symptom relief
  • Purported anti-aging, sexual vibrancy and
    energizing effects are similar to
    structure/function claims made for dietary
    supplements rather than disease
    treatment/prevention claims made for drugs

Some Basic Facts First
  • Pharmacy compounding of BHT is now a
    multi-billion dollar a year industry
  • Bio-identical HR drugs are prescription drugs,
    not over-the-counter. Physicians are (or should
    be) always part of triad.
  • Absent active participation by the medical
    profession, this industry could not prosper or
    function the way it has
  • FDA has been fighting for decades over whether it
    has jurisdiction over pharmacy compounding at
    all, and to what degree

Why the Surge in Prescriptions for Bio-identicals
from Patient POV?
  • Response to widely publicized results from 2002
  • Suspicion of traditional medicine
  • Dislike of big Pharmaceutical companies
  • Perception its a safer alternative
  • Natural is equated with safer
  • Wider and more aggressive advertising, via
    internet and other media
  • Patient preference for alternative medicine. Begs
    question of just how alternative it is
  • Least likely reason patients still symptomatic
    on properly prescribed commercial HR products

Facts to Frame the Harm Q
  • Little or no substantive data comparing BHT with
    commercial HT. The studies all have deficiencies
  • Given uncertainty over whether FDA really can
    regulate, no real incentive on the supply side
    for anyone to do randomized, controlled or
    comparative studies it would be great if someone
  • Almost all potential patients could obtain
    adequate medical therapy/symptom relief with
    commercial HR were they prescribed properly and
    patients so inclined to take them

The Problems with BHT
  • No tested in good clinical trials, and no
    endometrial safety data
  • Natural does not really equal safer
  • No clinician or patient package inserts
    documenting safety/efficacy, and no black box
  • No uniform manufacturing standards. In one study
    25 of compounded products tested failed quality
    control testing vs. 2 of commercially
    manufactured drug products
  • No formal review of accuracy of advertised claims
  • This is A LOT of Nots. Will it even matter to
    those determined to take these products?

There Would Be No Harm If the Following Were All
  • Patients fully informed of true risks/safety
  • Physicians fully aware of limitations on
    safety/efficacy data
  • All advertising of risks/benefits is completely
  • The pharmacies all product a consistent,
    excellent product and did not attempt to practice
  • All prescriptions were completely legitimate
  • Salivary hormones levels actually meant something
    and were inexpensive to boot
  • BHT were proven as safe and effective as other HR
  • FDA found more important things to regulate

What Harm/Potential Harms, and Harm to Whom?
  • To patients?
  • To prescribing physicians?
  • To medical societies?
  • To the medical profession?
  • To commercial drug manufacturers?
  • To compounding pharmacies and their industry?
  • To regulatory agencies such as FDA and state
    pharmacy/medical boards?
  • To the reputation of our federal courts?

Discuss Data Before Harms Likely Bottom Lines
  • BHT may be just as effective as commercial HR,
    and likely is so though never proven to be
  • BHT never been shown to be safer or more
  • BHT should be just as safe as commercial HR, but
    theres no reason for it to be any safer than any
    other HR
  • If all this is true, why are physicians writing
    so many prescriptions? Because medicine is more
    than an art, its also a trade/business

Summary of Recent Literature
  • Cirigliano M. Bioidentical Hormone Therapy A
    Review of the Evidence. J. Womens Health 16
  • Moskowitz D. A Comprehensive Review of the Safety
    and Efficacy of Bioidentical Hormones for the
    Management of Menopause and Related Health Risks.
    Alternative Medicine Review 2006
  • Fugh-Berman A et al. Bioidentical Hormones for
    Menopausal Hormone Therapy Variation on a Theme.
    J. Gen. Internal Med. 22 2007. This one points
    out that use of salivary hormone levels may
    result in use of doses that are higher than the
    least effective dose (LED), an approach favored
    by both medical societies and FDA Guidance

Practices Which Dont Measure Up
  • The salivary hormone level thing. Lets call it
    friendo this is junk medicine
  • Promoting BHT as safer, more effective, or
  • Promoting BHT as a wholesale replacement for
    commercial HR products. This is not compounding.
  • Not taking enforcement actions against those
    pharmacies which are the biggest offenders
  • State boards not pursuing fraudulent activity

How Do Some Compounding Pharmacies Hurt Patients?
  • practice medicine by adjusting doses of BHT
    independent of physicians.
  • Note something is needed to adjust doses in
    order to claim that the therapy is individualized
  • Promote these products globally to any patient as
    a replacement for commercial HR products which
    are safe and effective for most patients
  • Make false claims regarding safety/efficacy
  • Overcharge for these meds?
  • Largest compounding pharmacies just drug
    manufacturers in disguise
  • Continued litigation by some pharmacies over 1st
    amendment issues now runs risk of eliminating
    availability of compounded drugs for many patients

How Do Physicians Hurt Patients?
  • By taking patients off meds with known safety and
    efficacy profiles to place them on BHT where
    these are unknown
  • Waste scarce patient financial resources on
    meaningless hormone level testing and more
    expensive BHT that offers no therapeutic
  • Just because patients want it and are willing to
    pay for it does not mean you have to go along
    with it. How about medical decision making
    prescribe only when its indicated

How Can Federal Courts Hurt Patients?
  • By holding that all compounded prescription drugs
    are new drugs, as defined by the 1938 FDCA
  • In the long run this could restrict availability
    of many kinds of compounded prescription drug
  • Could theoretically require pharmacies to do
    clinical trial to support an NDA to meet new drug
    approval requirements
  • Could force pharmacies into doing IND
    applications in order to demonstrate that they
    are planning on submitting an NDA.
  • No pharmacy can really afford to do either of

Update on Federal Litigation Over Pharmacy
  • Historically most drugs were compounded drugs
    now only 8
  • FDA originally considered all compounded drugs to
    be new drugs, but left much of this practice
    alone and intent only to intervene when
    pharmacies were manufacturing, not compounding
  • 1997 FDAMA abandons FDAs long-standing position
    on compounding but creates bigger problems with
    FDAs attempt to restrict promotion of specific
    compounded products, as opposed to pharmacies
    just advertising that they compound
  • Results in Western States litigation which FDA
  • FDA then back to enforcement discretion
    approach to selectively intervene pharmacy
    industry still takes position compounding is
    integral part of normal practice of pharmacy and
    none of FDAs business
  • The problem is the litigation doesnt stop

Most Recent Federal Court Decision Continues to
Create Problems
  • Med Ctr Pharm v. Gonzales (W.D. Tex 2006) holds
    compounded drugs are not new drugs in a bench
    trial. FDA loses, but appeals
  • Med Ctr Pharm v. Mukasey (5th Circuit 2008)
    reverses but muddies the waters
  • Compounded drugs ARE new drugs and FDA can
    regulate, BUT
  • Congress did not intend to deem all compounded
    drugs new drugs, and
  • Disagrees with 9th Circuit and holds that 503A
    of FDAMA does remain in effect (even FDA had
    agreed it was no longer in effect) and that the
    advertising restriction sub-section could be
    split off from the rest of the section (something
    the 9th Circuit said could not be done) and that
    alone was invalid
  • All of this leaves us where, exactly? Confused
    yet? They are

Medical Center Pharmacy v. Mukasey (5th Circuit
  • Importance relates to Section 503A of FDCA
  • In the 9th Circuit territory (California, Nevada,
    Arizona, Oregon, Washington) pharmacists cannot
    claim protection of this section (under FDAMA FDA
    ceded jurisdiction over compounding to the
    states), whereas they can in 5th Circuit
  • Status of all of this in the rest of the U.S. now
    uncertain because of split in Appellate Courts
  • These cases not originally driven by FDA but
    rather by compounding pharmacies who claimed FDA
    attempts to restrict their advertising of
    specific compounded drug products violated their
    commercial speech rights under the 1st amendment
  • The problem is that they have now jeopardized all
    of pharmacy compounding because this will likely
    go up to the Supreme Court and how they will
    decide is not known.
  • This was not the case when I talked at NAMS on
    this in 2006

Implications if compounded drugs are new drugs
by ruling
  • FDA has real jurisdiction over all of it
  • If sold compounded drug not supported by an
    approved NDA can either be seized or pharmacy
    enjoined from making and selling. End result
    some patients wont get these meds
  • No pharmacy has 800K lying around to invest in
    an NDA application or the millions it will take
    to do clinical trials to prove they are safe and
  • Pharmacy compounding could cease to exist
  • FDA will likely selectively enforce to prevent
    this, and the whole litigation cycle will start
    all over again since enforcement criteria will be
    somewhat arbitrary (i.e. if youre making too
    much then you are a manufacturer, not a
    traditional compounding pharmacy)

Enough about Judicial Harm.Can Patients Hurt
  • Patients have this right. Physicians do not.
  • Patients can, and do, ask for medications and
    procedures that are either worthless, harmful, or
    frivolous. Look at dietary supplements, plastic
    surgery, and C-Section on demand.
  • It is the medical professions job to place real
    limits on this. It is our fiduciary duty to do
  • Also, its bad enough when patients waste their
    own money. Indirectly, they are wasting others
    as well
  • The tradeoff patient autonomy vs. evidence based
    medicine. What do we stand for as a profession,

A final harm Medical Information via the Internet
  • Its totally unregulated
  • FDA has not even begun to really engage this
    issue, nor has the medical profession (or anyone
    else) really
  • Supreme Court takes the position that information
    is better than restriction of information
  • Lots of horribly false or misleading info out
    there the latter is ok according to courts if
    there is a disclaimer even though evidence
    strongly suggests these are worthless
  • BUT, this is also an opportunity for medicine
    medical societies, our profession to seize the
    initiative and assert some good information

What Must the Pharmacy Profession Do to Help
  • Better self-regulation so the feds and state
    boards dont step in
  • Get rid of false and misleading advertising
  • Reign in the worst offenders they are ruining it
    for everyone else. Its no different than the
    Ephedra/dietary supplement debacle

What Must Medicine Do, or Try to Do, To Correct
  • Real effort at self-regulation. A license to
    practice medicine is not a license to practice
    junk medicine
  • Make a determined effort to do the comparative
    trials to evaluate BHT claims
  • Medical societies should consider issuing
    opinions about setting limits on patient demands.
    We are not selling pizza.
  • Full disclosure to patients of your financial
    investments in labs and pharmacies wrapped up in
    the BHT process
  • As for the physicians who genuinely believe
    everything thats out there about BHT as well as
    the pseudoscience behind salivary hormone levels,
    Im not sure what we can do about this

What Must Federal Courts Do?
  • Sigh
  • Its always a thrill when federal courts weigh in
    on medical matters. Between abortion and autism,
    theres no telling where things are headed (and
    thats just the as)
  • It is possible the status of pharmacy compounding
    will now end up in front of the Supreme Court. If
    it does not, well have different regulatory
    systems in different parts of the U.S.

What Should State Boards Do?
  • Protect their citizens by taking enforcement
    actions against marginal and fraudulent medical
    and pharmacy practices
  • Police fraudulent claims in ads
  • The First Amendment offers no protection for lies

This is Not Just a U.S. Issue
  • The health issues are a potential problem for all
    countries in North America even if the costs of
    compounded BHT and the manner in which the
    government regulates them is not.
  • Im open to suggestions from members of NAMS
    outside the U.S. on how to approach this issue

Summing Up the Harms
  • Economic (for patients)
  • Patient Safety (for patients). Need data
  • Regulatory for government and courts. The
    latter are confused, and confusing.
  • FDA whats the point if youre only going after
    the small fish?
  • Reputation for medical profession

Where We Are Likely Headed
  • A U.S. Supreme Court decision to resolve the
  • Compounding pharmacies will try to stay under the
    radar screen if they are smart, but it may be too
    late because of continued litigation in federal
  • Medical societies such as NAMS will continue to
    do the correct thing by continuing physician and
    patient education. Perhaps more of an internet
    presence with very attractive, and the best,
  • Medical profession self-regulating dont count
    on it, but greater effort to kill medicine with
    no good evidentiary basis would be a nice start

Thank You
  • Qui tacet consentire videtur
  • He who is silent is taken to agree