Dear Dr. Kleszynski,
Thank you for your reply. As an ethical dentist as you
describe yourself, you surely are aware that the protecting the
patient's best interest is the paramount ethical obligation of all dentists.
Furthermore, it is unethical to practice or promote negligent dental practice.
For more than a decade the American Association of Endodontists position paper
is that the use of Sargenti paste constitutes substandard practice.
Endodontists set the standard of care in endodontic practice. Furthermore, all U.S. endodontic
departments teach that Sargenti paste should not be used since it is a toxic
substance whose risk of causing serious or catastrophic injury is greater than
the benefit. If the risk exceeds the benefit then all reasonable practitioners
would elect to choose to instead use a safe and effective alternative
therapy. How can you ethically justify providing your society's
imprimatur on a risky and dangerous technique when safe and time tested
alternative therapies with proven effectiveness exist? What is your
rationale?
You say that the Sargenti method has successfully treated
"many thousands of patients". In reply I will quote from
an FDA letter as they have replied to those same arguments in regard to
Sargenti paste.
"The FDA does not "poll" users to
determine drug effectiveness. "The responsibility for determining this
rests with the drug manufacturer and must have some basis in science not
testimonials," the letter stated, adding that adequate and well-controlled
studies provide the basis for the agency's evaluation of a drug."
Also, your suggestion that patients have benefited from Sargenti is analogous
to Merck arguing many patients benefited from Vioxx except those few who died
or suffered debilitating strokes and heart attacks. Because the risk
exceeded the benefit and safe alternative drugs existed Merck withdrew Vioxx
from the market anticipating the FDA would do likewise. The same FDA has
specifically refused to approve Sargenti as safe and effective. Moreover,
Sargenti proponents have had over three decades to prove its safety and
effectiveness to the FDA and have yet to succeed. Does your society claim
greater scientific expertise than the FDA?
Another analogy is to claim that speeding drivers get to
their destinations faster and therefore speeding is a more efficient way
to travel. This argument ignores those speeding drivers who kill
innocent people. The risk of serious injury or death is not worth the efficient
way to speedily travel and is therefore outlawed. Even if most
speeding drivers arrive safely and more quickly, it does not justify the
risk of such an unsafe practice. How many more patients does Sargenti paste
have to maim and destroy the quality of their life before your society will
recognize the potential harm as your organization provides cover to Sargenti
promoters with your implied recognition if not endorsement? Is it one
more, ten more or a hundred more maimed for life patients? Most injured
patients either don't discover that Sargenti
paste injured them as the dentist frequently conceals
what endodontic drug was used or even if told most patients accept their fate.
Very few ever avail themselves of MedWatch reporting to the FDA. When is the
last if not the first time you ever reported an adverse event to the FDA with a
voluntary MedWatch report? Are you any different in FDA MedWatch reporting
than the vast majority of dentists?
Finally, as the director of Scientific Programs for the
CDS which is allowing these Sargenti clinic tables, can you cite any
research study that demonstrates comparative effectiveness and safety of
Sargenti compared to conventional endodontic fillers and sealants? Ethical drug
companies sell proven safe and effective endodontic fillers and sealants which U.S. dental
schools teach as the recommended endodontic drug which should be used to fill
and seal root canals? As an organization devoted to scientific progress and
education I would hope you respond by providing the scientific research
that supports your tacit endorsement of an endodontic drug which mummifies
nerve tissue. As Stephen Cohen, DDS, editor of Pathways of the Pulp, teaches in
advocating against Sargenti, "No one should be embalmed before their
time". Placing such a toxic drug in the hands of dentists who know that
overfills on occasion happen is not worth the risk of mummifying the inferior
alveolar and/or maxillary nerves, and damaging tissue, bone and blood
vessels of patients such as myself and others.
Consequently, we the patient, pay the ultimate price
for this unnecessarily toxic chemical. Is speedier endodontics with
unsafe Sargenti worth this price? Primum non nocere teaches ethical dentists
otherwise.
Yours for better dentistry through safer chemistry,
Attachment: Letter from CDS/Aloysius Kleszynski
to Claudia Megaro
cc: Daniel Bluthardt, Director ยท Division of Professional
Regulation
Michael McRaith, Acting
Secretary of IDFPR
Lisa Madigan, Attorney General
Anthony M. Spina, DDS, MD
Randall B. Grove, Executive
Director CDS
Lennoree Cleary, Office Manager