As of 2019, there are urine-free FDA-approved bioidentical hormones that skirt the standardization concerns of compounded preparations. Are they any safer?
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"Is FDA-Approved Bioidentical Hormone
Replacement Therapy Safe?"
¶
0:06.72
The news that
menopausal hormone therapy
0:09.78
had the potential to cause
higher rates of breast cancer,
0:12.12
cardiovascular disease,
and overall harm
0:14.76
rocked women and physicians
across the country.
0:18.42
The study arm used progesterone
and Premarin,
0:21.24
because it was the most commonly
prescribed form of estrogen
0:24.00
and is still prescribed
0:24.96
more than a million times
a year in the U.S.
0:27.30
It's a mixture of more
than 50 different estrogens
0:30.54
from horse pee.
0:31.74
("Premarin" comes from the words
"pregnant mare urine,"
0:35.28
if you're skeptical,
0:36.42
try crushing a pill
and sniffing it.)
0:40.02
The dour findings
of the Women's Health Initiative
0:42.96
(combined with some high-profile
celebrity endorsements)
0:45.90
saw interest shift
to "bioidentical hormones,"
0:48.96
made from plants
rather than a horse source.
0:51.48
They are marketed as being safer
and more effective.
0:54.42
No wonder estimates
peg the annual number
0:57.06
of prescriptions
at 30 million a year,
0:59.40
constituting
a billion-dollar industry.
1:02.64
One reason patients may believe
compounded hormone therapy
1:06.30
is safer is that,
thanks to a legal loophole,
1:08.64
they are not mandated
to provide
1:10.44
the FDA insert required
for commercial products
1:13.26
warning about side effects.
1:15.00
Purchased at regular pharmacies,
1:17.04
hormones have
a prominent black box
1:19.14
with an all-caps
"WARNING: ENDOMETRIAL CANCER,
1:22.26
CARDIOVASCULAR DISORDERS,
BREAST CANCER,
1:24.12
AND PROBABLE DEMENTIA."
1:26.22
There's no evidence
that bioidentical hormones
1:28.92
are any safer,
1:29.88
but the missing laundry list
of side effects
1:32.22
may give patients
a false sense of security.
1:34.14
Another appeal
is customized dosing
1:37.74
based on saliva hormone testing,
1:40.02
but such tests are considered
to be unreliable
1:43.74
and so recommended against,
1:45.78
since the only people
who profit
1:47.88
are the ones
trying to sell you the tests.
1:51.24
Custom-compounded hormones
are not FDA-approved,
1:54.72
have not been shown to be safer
or more effective,
1:57.18
and may lack standardization
of quality, purity, and dose.
2:01.14
When the FDA
or muckraking journalists
2:04.08
have filled
the same prescriptions
2:05.46
in compounding pharmacies
in different states,
2:07.44
a third of the stated
estrogen contents
2:10.44
were off
by as much as 250 percent.
2:13.50
No wonder all the major
American medical societies
2:16.98
that counsel physicians
on treating menopausal women
2:19.50
recommend against
compounded hormones,
2:21.54
including the American College
of Obstetrics and Gynecology,
2:24.00
the Endocrine Society,
2:25.62
and the North American
Menopause Society.
2:28.38
Characterizing the pushback
they got from their 2020 review
2:31.62
recommending against the use
of bioidentical hormones,
2:34.38
the National Academies
of Sciences,
2:36.54
Engineering,
and Medicine concluded,
2:38.28
"It is clear
from these communications
2:41.10
that many clinicians,
compounding pharmacists,
2:43.26
and patients hold minimum,
if any,
2:45.66
concerns regarding
the medication's safety
2:47.94
and effectiveness."
2:49.86
Now, as of 2019,
2:51.18
there are pee-free FDA-approved
bioidentical hormones
2:54.96
that skirt
the standardization concerns
2:57.36
of compounded preparations,
2:58.62
but that just brings us back
to square one,
3:02.10
since they are considered
3:03.12
to have
the same risk/benefit profile.
3:05.10
The multibillion-dollar
compounded hormone industry
3:08.82
is considered a "leading source
of disinformation,"
3:11.88
but the same could be said
of Big Pharma.
3:14.94
With so many billions of dollars
at stake,
3:17.58
it's hard to know
who to trust.
3:18.90
When in doubt,
I turn to The Medical Letter
3:22.68
on Drugs and Therapeutics,
3:24.00
considered one
of the least biased sources
3:26.46
in medicine.
3:26.94
It's kind of like
the Consumer Reports
3:29.46
of the drug world,
and, in fact,
3:31.68
was actually co-founded
by the co-founder
3:33.84
of the publisher
of Consumer Reports
3:35.34
more than 50 years ago.
3:37.32
As The Medical Letter
used to brag on their website,
3:40.32
it "does not accept grants,
from any source;
3:43.02
donations, from anyone;
[or] funding, from any entity."
3:46.20
They won't let their work be
used for promotional purposes,
3:49.26
and they don't accept
any advertising.
3:51.18
In their review of the evidence,
they concluded,
3:53.82
"There is no acceptable evidence
3:56.16
that bio-identical hormones
are safer."
4:00.00
So, how do you treat
menopausal symptoms
4:01.80
like hot flashes?
4:02.88
The American College of
Obstetricians and Gynecologists
4:05.64
suggests palliative measures,
such as "consuming cool drinks,"
4:09.06
but is there really no way
to treat hot flashes
4:12.36
without the cancer, clots,
and coronaries?
4:15.24
Thankfully there is,
4:17.22
as I cover in a video series
that starts with
4:19.56
Menopausal Hot Flashes
Are Not Inevitable
4:22.26
and then moves
from prevention to treatment.
