The
Grisanti Report
A Reliable Source for
Alternative Medical Advice
Report
#1227
What Every Hypothyroid Patient
Should Know about Synthroid
Written & Researched by
Ronald J. Grisanti
Special Thanks to John Lowe www.drlowe.com
Synthroid, a brand of thyroid
hormone, is the third most prescribed drug in the United States. Back in the
1980's, Synthroid was the only brand of thyroid hormone that mainstream
physicians would prescribe. Most physicians refused to prescribe other brands of
thyroid medication. This was due in part by the powerful marketing campaign by
Synthroid's manufacturers - formerly Knoll Pharmaceuticals (Knoll) and now
Abbott Laboratories (Abbott). In addition, Synthroid received the "stamp of
approval" from the endocrinology specialty. Mainstream medical physicians
believed and many still do that Synthroid was the absolute best of the thyroid
hormone products.
Unfortunately, a growing number of physicians
were becoming frustrated with the lack of consistent results with Synthroid.
While some patients did improve, many others did not, causing physicians to
question the reliability of this heavily marketed drug.
With the emergence of progressive thinking
medical physicians came a new way of looking at disease as well as a more
productive way of prescribing medication.
More and more physicians realized the
limitation of Synthroid and began prescribing Armour Thyroid or Thyrolar. The
results were astonishing!! Physicians were seeing a greater percentage of their
patients improving.
From a pharmaceutical stand-point, Synthroid
is a T4 only medication while Armour Thyroid and Thyrolar are both T3 and T4.
These are brands of thyroid hormone that contain both T4 (levothyroxine) and T3
(triiodothyronine).
Despite Synthroid's relative ineffectiveness,
when mainstream MDs in the United States diagnose hypothyroidism, they
habitually write "Synthroid" on their prescription pads. Why? Because dogged
endorsements of the drug by endocrinologists have fused the words hypothyroidism
and Synthroid as inseparably as runny nose and Kleenex.
Why Endocrinologists Endorse
Synthroid
Endocrinologists dictate other mainstream
medical specialists' beliefs about hypothyroidism and its treatment. One such
belief is that the proper aim of thyroid hormone therapy is to bring the
patient's thyroid-stimulating hormone (TSH) blood level into the reference range
(formerly called the "normal range"). To endocrinologists, when a patient's TSH
level is within this range, the patient is said to be well, even if he or she
remains disabled by hypothyroid symptoms.
Treating hypothyroid patients according to
this criterion has left millions of them chronically ill, disabled, and
prematurely dead. The reason is clear. During primary hypothyroidism, the
pituitary gland increases its release of TSH, raising the blood level above the
reference range. The pituitary is highly sensitive to T4, and small dosages of
T4 decrease the pituitary release of TSH, lowering it into the reference range.
Tissues other than the pituitary are comparatively insensitive to small dosages
of T4. Much higher dosages are required to normalize the metabolism of these
other tissues. However, T4 does not increase the metabolism of many patients'
tissues, no matter how high the dosage. Only a thyroid hormone preparation
that contains T3 will accelerate these patients' metabolism. Hence, when T4
therapy normalizes TSH blood levels of many patients, it leaves their
metabolism subnormal. These patients remain symptomatic despite their normal
TSH levels. This finding has led researchers to urge physicians to no longer
base patients' thyroid hormone dosages by TSH levels.
In view of this, why do endocrinologists
resolutely endorse Synthroid as the only brand of thyroid hormone any
hypothyroid patient ever needs to use? The cause is a complex interplay of
factors. Prominent among them are financial incentives to the endocrinology
specialty from corporate marketers of Synthroid. The corporations have richly
funded the specialty. He who pays the piper, of course, calls the tune. This
reality makes the proposition plausible that lavish funding by these
corporations has shaped endocrinologists' beliefs about hypothyroidism - beliefs
that are favorable, quid pro quo, to the financial interests of the
corporations, yet shown false by substantial scientific evidence.
Ample evidence supports the belief that
endocrinologists' endorsement of Synthroid has been strongly influenced by
financial incentives from the corporations. An example is a million-dollar
donation by Knoll to the American Thyroid Society (ATS) to fund thyroid
research. The studies ATS funds with that money will be those whose outcomes are
likely to favor the financial interests of the corporation. Studies that would
militate against the corporation's financial interests are not likely to be
funded. This type of mutual support ensures a continuing financial relationship
between research organizations and funding corporations.
Renowned thyroid patient advocate Mary Shomon
recently noted that the American Association of Clinical Endocrinologists (AACE)
"has a longstanding financial relationship with the manufacturers of Synthroid."
The AACE's web page listing its sponsors verifies that Synthroid subsidizes the
organization. Knoll funded AACE's work to develop practice guidelines for the
diagnosis and treatment of hypothyroidism. It is no surprise that the guidelines
mention no treatment for hypothyroidism other than T4. This endorsement of T4
dovetails with endocrinologists' oft-repeated public endorsement of
Synthroid.
Dr. Rhoda Cobin, president of AACE, recently
wrote in the Wall Street Journal that the organization does not endorse
specific products. Yet in the same letter, she - the AACE's top official -
endorsed Synthroid: "The 3,700 physicians in our organization, all specialists
in thyroid disease, have found that Synthroid has a long record of safety,
efficacy, reliability and consistency." Mary Shomon pointed out that the
homepage of the Synthroid website prominently displays an AACE press release
supportive of Synthroid.
FDA Action against Synthroid
Despite such assurances by endocrinologists,
and despite corporations having marketed Synthroid for 30 years, the FDA has not
approved the product for the treatment of hypothyroidism. Knoll recently
requested that the FDA waive requirements for "adequate and well-controlled
studies" of Synthroid and grant it status as "generally recognized as safe and
effective." The FDA refused and required Knoll to apply for a new drug
application following proper testing for safety and effectiveness.
The reasons FDA gave for its decision about
Synthroid contradict the reassurances of endocrinologists.' "Patients using
Synthroid," the FDA wrote, "have experienced significant, unintended variations
in their doses of [T4] ... these variations are not conducive to proper control
of hypothyroidism."
The FDA also wrote of Synthroid: "Its formula
has been changed numerous times throughout its marketing history."
The agency cited a long history of
manufacturing problems, subpotency, stability, and reliability issues. "In
August of 1989," the FDA noted, "Knoll initiated a recall of 21 lots of
Synthroid tablets." The reason for the recall was low potency during stability
studies. In 1991, Knoll recalled 26 subpotent lots of Synthroid in February and
other lots in June. Inspections of a Synthroid manufacturing plant led to
citations for deviations from good manufacturing practices: two in April 1991,
and nine in December 1992. Knoll distributed subpotent Synthroid during 1990,
1991, and 1992. The FDA summarized:
"The history of potency failures ...
indicates that Synthroid has not been reliably potent and stable. Furthermore,
Knoll's use of an overage [in potency] that has not remained consistent over the
years suggests that Synthroid has stability, potency, and consistency problems.
Although you [Knoll] claim that Synthroid has been carefully manufactured, the
violations of current good manufacturing practices discussed above indicate that
Knoll has not always manufactured Synthroid in accordance with current standards
for pharmaceutical manufacturing."
On August 1, 2001, Abbott Labs, after
acquiring Knoll, submitted to the FDA a new drug application for Synthroid.
Those concerned over the Synthroid problem can stay abreast of FDA actions
against its manufacturer through Mary Shomon's newsletter, Sticking Out Our
Necks.
In summary, evidence indicates that financial
incentives from the marketers of Synthroid have influenced endocrinologists to
endorse the product. Synthroid has a history of manufacturing, stability, and
potency problems, and it has not met FDA criteria for effectiveness and safety.
These problems with product quality led to FDA action against Synthroid. Many
alternative medical physicians report that treatment results with Synthroid
are inferior to those with products containing both T4 and T3, or T3
alone.
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References
- Lowe JC. Letter to the General Medical Council. London, United Kingdom,
April 17, 2001. http://www.drlowe.com/news/drpeatfield/jclletter.htm
- Mary Shomon's thyroid site: http://www.thyroid-info.com/
- Lowe JC. T3-induced recovery from fibromyalgia by a hypothyroid patient
resistant to T4 and desiccated thyroid. J Myofascial Ther 1(4):26-31,
1995.
- Lowe JC. The Metabolic Treatment of Fibromyalgia. Boulder, McDowell
Publishing Co., 2000.
- Lowe J, Honeyman-Lowe G. Thyroid disease and fibromyalgia syndrome. Lyon
Mйditerranйe Mйdical: Mйdecine du Sud-Est 36(1):15-17, 2000.
- Derry DM: Consequences of the TSH. Brit Med J May 29, 2000.
- Skinner GRB, Holmes D, Ahmad A, Davies J, Benitez J. Clinical response to
thyroxine sodium in clinically hypothyroid but biochemically euthyroid patients.
J Nutri. Environ Med 10:115-124, 2000.
- Greene LW. Information on hypothyroidism at Healthology website. Go to
http://www.healthology.com and type "Greene" in its search engine box,
then follow the links to videos from there.
- Shomon M. Endocrinologists defend Synthroid in Wall Street Journal.
Sticking Our Necks Out: The Thyroid Disease News Report, July/August, 2001,
p.3.
- Dobin R. Letter to the editor: Synthroid has record of safety and efficacy.
Wall Street Journal, June 20, 2001.
- http://www.synthroid.com
- http://www.aace.com/spon main.htm
- Shomon M. Synthroid files for FDA approval, will remain on market, but with
production phase-out. Sticking Our Necks Out: The Thyroid Disease News
Report, July/August, 2001, pp.1-2.
- http://www.nacb.org/Thyroid_ LMPG.html
- American Thyroid Association,1999.
http://www.thyroid.org/press/pr991004.htm
- American Association of Clinical Endocrinologists thanks Knoll
Pharmaceutical Company for an educational grant to support the development of
practice guidelines, 1996. http://www.aace.com/clinguideindex.htm
- Food and Drug Administration. Letter to Knoll Pharmaceutical Company, April
26, 2001.
- Shomon M. FDA refuses Synthroid's generally recognized as safe and effective
status, Abbott Labs forced to submit new drug application. Sticking Our Necks
Out: The Thyroid Disease News Report, May/June, 2001, p.4.
- http://www.thyroid-info.com/subscribe.htm
Click here for an explanation on Thyroid Laboratory
Tests
Question?
© 2001 Ronald J. Grisanti D.C.,
D.A.B.C.O
NOTICE: This information is provided for
educational purposes. Any medical procedures, dietary changes, or nutritional
supplements discussed herein should only be undertaken on the advice of a
qualified physician.
Ronald J. Grisanti, D.C.,
D.A.B.C.O
The Grisanti Center of Integrative Medicine
4200 East North
Street, Suite 14 • Greenville, SC 29615
(864) 292-0226 • FAX: (864)
268-7022
Reprinted from:
http://www.drgrisanti.com/Hypothyroidism.htm
