Ethical Implications of Cosmetic Surgery for Aging
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PUBLIC CITIZEN HEALTH RESEARCH GROUP
SIDNEY M. WOLFE, M.D., EDITOR AUGUST 2002 + VOL. 18, NO. 8
Ethical Implications of Cosmetic Surgery for Aging
ombine the aging of our popu- the procedures they perform. gether, changing the goal of medi-
C lation, our obsession with
youth, and our faith in tech-
nology with excesses of disposable
Let us start by examining the cen-
tral question, "Why perform cosmet-
ic surgery for aging?" If the goal of
cine from promotion of health to
promotion of happiness. Each of
these will be examined in turn.
income for many people, and it is no medical treatment is to promote
surprise that we are awash in techno- health and healing, what is the pur- Aging as a Physical Illness
logic advances in the battle against pose of medical procedures where If aging of the skin is a pathologi-
visible signs of aging. Setting aside, no disease exists, i.e. in performing cal rather than a normal, physiologi-
for the moment, the heavily adver- surgery for aging? cal process, eventual dissatisfaction
tised, poorly-researched, and often The professional literature on the with our appearance is unavoidable
downright fraudulent vitamin E, B, C- ethics of cosmetic surgery, though and youth-promoting, cosmetic pro-
alphahydroxy-retinol-herbal-antioxi- disturbingly sparse, takes one of cedures are required for good health.
dant-collagen-aminoacid-mineral three tacks, each of which is highly Although the concept of aging as a
antiaging concoctions, real techno- questionable. The first is that aging is disease seems peculiar to most of us,
logic advances have occurred over a physical disease and that external it is standard for cosmetic surgeons,
the last decade that have made it pos- signs of aging are de facto evidence who discuss the treatment of brown
sible to erase external signs of aging of illness. The second avoids the spots, repair of wrinkles, and correc-
previously considered indelible. But issue of aging as a physical disease tion of sagging skin as if aging were
while physicians have made the tech- by ascribing illness to the patient's a disease which needs to be treated,
nology of "skin rejuvenation" increas- mind rather than body. The third repaired, or corrected. Topics such
ingly accessible, its intrinsic value skirts the question of healing alto- continued on page 2
and ethical implications have been
largely unquestioned by the medical CONTENTS
community. Why do we perform
these procedures? What goals are we Product Recalls
trying to achieve? Are these goals May 7-July 10, 2002
worthwhile? What is their impact on Tamiflu capsules, power tooth brushes and propane heaters
patients? On medicine? On society? A are on our list this month .......................................................... ............ 4
situation has developed in which
there has been ample investigation Is Your Doctor Selling You to the Highest Bidder?
into what physicians can do, but far Find out why it's important to know who is funding human
less examination of what they should experiments and if they're paying your doctor to recruit you ........... 7
do. Cosmetic procedures are inva- Hormone Replacement Therapy
sive, potentially hazardous tech- A recent study supports recommendations we made 11 years ago ... 8
niques that have implications far
beyond their value as "practice Outrage of the Month
builders." As physicians enter the "'t's Botox Night at Hopkins"
realm of cosmetic surgery, they have Find out how Johns Hopkins planned a social event including
a responsibility to explore the moral on the spot injections for wrinkles-and how Public Citizen
and psychosocial as well as the sci- helped stop it. ............ ...................... .. .................. .......................... ... ... 12
entific and technical implications of
VISIT HEALTH RESEARCH GROUP'S WEB SITE AT \VWW.CITIZEN.ORG/IIRG/
as the "treatment of the aging face," examined objectively, the proper text. of cosmetic surgery for aging?
are discussed with the same weight determinant of healthy skin is its (Though this question may seem
as treatment of diabetes or treatment function, not its appearance. Despite unnecessarily pedantic, anyone in
of tuberculosis. After all, the object of its spots and wrinkles, elderly skin the business of physically altering
treatment is necessarily disease; nor- functions remarkably well in the another human being in the name of
mal, physiologic processes, such as vast majority of individuals far into self-esteem had better have a pretty
breathing or eating, cannot be treat- old age. Some functional problems, good idea of just what self-esteem is
ed. By making the aging face the such as a decline in the skin's pro- and what enhances it.) Although
object of treatment, aging is defined tective barrier function, occasionally pride in one's appearance is certain-
as a disease that requires interven- become clinical problems, but the ly part of the definition, equating
tion. correction of these conditions is self-esteem with pride somehow
There are both practical and theo- hardly the objective of cosmetic sur- misses the mark. We all know vain,
retical problems with defining aging gery. In fact, the injury to the skin self-absorbed, proud individuals who
as an illness. Perhaps the most prob- surface incurred by laser resurfacing, are preoccupied with their appear-
lematic is that, in defining aging as chemical peeling, and other popular ance because of insecurity rather
an illness, we implicitly define life as cosmetic techniques exacerbates than self-esteem. If pride is to result
an illness. Aging may end with rather than ameliorates the defect in in self-esteem rather than vanity, it
death, but it begins at birth. How do barrier function. must include an additional element,
we know at what point aging namely, authenticity. Any self-image
changes from physiology to patholo" Aging as a Mental Illness worthy of enhancement, through
gy? Who is to say that puberty is As much as cosmetic surgery may cosmetic surgery or other means,
acceptable, but menopause is not? invoke a model of disease to legit- must be a true reflection of who that
Growth continues throughout our imize its place in medicine, the con- person is. Enhancement of a false
lives on many different levels. To cept of a "cosmetic disease" is a hard self-image can result in narcissism or
demean aging by labeling it a disease sell to the public, which tends to even self-contempt, but it does not
limits our potential and undermines view cosmetic procedures as frivo- result in true self-esteem.
our humanity. lous, and to insurance carriers, which The self that benefits from cosmet-
Unlike plastic surgery, which cor- ic surgery is an impostor. It is built
rects deformities that deviate from on the premise that pretending to be
the anatomical norm, surgery for the something we are not builds charac-
aging face removes anatomically nor- What is the meaning ter. Cosmetic surgeons are in the
mal features because they trigger a business, not of enhancing who we
negative stereotype. Every time sur- of self-esteem in are, but of replacing who we are
geons agree to perform a facelift, with who we or they think we
they legitimize the need for that the context of should be. Only a false self created
facelift. They confirm that looking by the myth of agelessness can prof-
old is objectionable, that aging is an cosmetic surgery it from surgery for aging. Only an
aberration, and that society is justi- idealized self in pursuit of perpetual
fied in discriminating against it. At for aging? youth can benefit from procedures to
medical conferences in this country, erase the effects of time. There is no
the mere presence of aging skin is question that a false self can be bol-
tantamount to an indication for cos- stered by any of a number of cos-
metic surgery. Of course, such atti- classify them as unnecessary. In metic disguises. But how do people
tudes are not unique to medicine. response, cosmetic surgery has whose worth is defined by a vision
The cosmetic industry has made a increasingly taken to promoting itself of eternal youth maintain self-esteem
multimillion dollar business of blur- as a cure, not for the body, but for with time gnawing at their heels?
ring the lines between health, beau- the mind-a sort of instant alterna- How do we maintain our equanimity
ty, and aging, portraying health and tive to psychotherapy for aging indi- knowing that the image we have cre-
beauty as attributes of youth while viduals who suffer from lack of self- ated is a fraud? As much as we may
assigning ugliness and disease to the esteem. Perhap$ then, as a therapy cover, smooth, or conceal the exter-
elderly. But physicians are charged for psychological disease, cosmetic nal evidence, each day we are 24
with protecting the health and well- surgery for aging could be a legiti- hours older and, in the end, we are
being of their patients, and it is diffi- mate form of medical treatment. who we are. In this context, a
cult to believe that fostering the atti- Before tackling the issue of request for cosmetic surgery seems
tude that aging skin is inherently whether cosmetic surgery enhances more like self-abnegation than self-
offensive is in the best interest of self-esteem, a more basic question esteem.
their patients. needs to be addressed: what is the The truly insidious part of nurtur-
Is aging really a disease? When meaning of self-esteem in the con- ing an illusion is that the true self,
2 +August 2002
that vulnerable, aging human crea- equal. The advice of physicians is as the goal of medicine, the practice
ture behind the cosmetic disguise, is implicitly coercive. When patients are of medicine becomes a commodity
neglected. There is real, physical told they need an appendectomy, and the medical profession just
beauty in all of us, whether at 20 or they are not receiving a casual sug- another venal example of the market
50 or 80. Think of photographs of gestion but an expert opinion that culture. Cosmetic surgeons may use
famous people taken when they surgery is required for their health. medical devices and receive profes-
were in their 70s or 80s- Mother Likewise, when cosmetic surgery sional training, but they engage in
Theresa, or Ernest Hemingway, per- patients are told they would benefit the business of selling pretty faces
haps. Would these people have ben- from a face lift, they are receiving pro- for a pretty price as much as any cor-
efited from "rejuvenation of the fessional validation that aging is unat- porate executive who promotes
aging face?'' That kind of beauty is tractive and that society is justified in beauty aids. Whereas the creation of
not something to be peeled away. judging them by their appearance. unnecessary markets is disagreeable
Another problem is that of scien- when the inventory is consumer
Aging and the Business of tific standards. In general medical goods, it is far more disturbing when
Medicine practice, physicians are entrusted the product is surgical procedures.
There is widespread recognition with restoring patients to a normal The inherent morbidity of the proce-
on the part of many people that cos- state of health. But unlike general dures, the vulnerability of the
metic surgery is not really required medicine, where there are objective patients, and the special privileges
for good health. We hear no public standards by which to judge the granted to physicians by society, all
outcry when insurance companies norm, cosmetics is a matter of style. demand a degree of moral conduct
deny benefits for face peels. There Thirty years ago, turned-up button surpassing anything suitable for a
are no charitable organizations solic- noses were all the rage; now larger, standard business contract.
iting funds to provide liposuction to more assertive noses are in vogue. Health, happiness, and beauty are
the needy. Accepting for the moment We are not talking science here; we not always compatible. The people
that cosmetic surgery does not treat are talking fashion. If happiness who lived in Aldous Huxley's Brave
real disease, perhaps it is acceptable rather than health were the real New World were all happy. They
within the context of a business objective of medical treatment, cos- were all happily narcotized on drugs
model of medicine. By transforming metic surgeons would be justified in and wanton sexuality. They were all
medicine from a profession to a busi- etching decorative scars on their cus- young and beautiful. They were all
ness, by changing its purpose from tomer's faces if they fancied the pat- free of wrinkles, of age spots, of tired
the promotion of health to the pro- terns. Our best physicians would eyes, of sagging skin. But their soci-
motion of happiness, surgery for hand out amphetamines as the most ety could hardly be called healthy.
aging could be viewed as a legiti- direct way of achieving happiness. They were a population of clones, all
mate service provided by doctors to Taken to the extreme, general sur- conforming to a preapproved, sani-
satisfy their customers. geons would be obliged to excise tized ideal of beauty. Sound familiar?
Accepting a business model for healthy organs if the patients Mr. Huxley wrote Brave New World
medicine presents several problems. believed they would be happier to make a point. It is time we took
Whereas business operates within a without them. The obligation of another look.
contractual paradigm, which pre- physicians is to make judgments to •••
sumes negotiations among equal par- protect their patients' health, not sim- Excerpts from this article were
ties, the relationship between physi- ply to please their customers. previously published in the Archives
cians and patients is anything but When happiness replaces healing of Dermatology.
' ' I 'A' I' • ' ' ' • ' ' I '
Editor ........................................... Sidney M. Wolfe
Managtng Edttor .................. Pbyllts McCarthy Hcaltl1 Letter The Health Research Group was co-founded
in 1971 by Ralph Nader and Sidney Wolfe in
Washington, D.C. to fight for the public's
Staff Researchers ........................ Etleen Rtngel health, and to give consumers more control
Peter Lurte over decisions that affect their health.
Benita Marcus Adler Copyright © Health Letter, 2002
Material in the Health Letter may not be
Information Spectaltst......john Paul Fawcett Published Monthly by
re-printed without permission from the Editor.
Public Citizen Health Research Group
Production Mgr. ...................... Krlsty l]ackson All rights reserved. ISSN 0882-598X Send letters and requests to HEAL1H LETfER,
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Our Web site address is www.citizen.org/hrg
Public Citizen's Health Research Group+ Health Letter+ 3
Product Recalls
May 7-]uly 10, 2002
T his chart includes recalls from the Food and Drug Administration (FDA) Enforcement Report for drugs, dietary
supplements and medical devices, and Consumer Product Safety Commission (CPSC) recalls of consumer products.
DRUGS AND DIETARY SUPPLEMENTS
The recalls noted here reflect actions taken by a firm to re~bve a product from the mark~t. Recalls may be con-
ducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority. A Class I recall is a situ-
ation in which there is a reasonable probability that the use of or exposure to the product will cause serious adverse
health consequences or death. Class II recalls may cause temporary or medically reversible adverse health conse-
quences. A Class III situation is not likely to cause adverse health effects. If you have any of the drugs noted here, label
them Do Not Use and put them in a secure place until you can return them to the place of purchase for a full refund.
You can also contact the manufacturer. If you want to report an adverse drug reaction to the FDA, call (800) FDA-1088.
The FDA web site is wwwfda.gov.
Na111e r!f Dru,~ rw SujJfJielllent; Clm .~ '!!'Rem((; Pmhle111 Lot #;Quantity anrl Di.\ lnbutum. Jlmlll}i~etm·er
Dalyvlte Liquid, a multi-vitamin liquid packed in brown, plastic bot- Lot 101624 EXP 2/03; 15,413-pint bottles distributed nationwide;
tles, One Pint (473 mL). Product was distributed under the Hi-Tech Hi-Tech Pharmacal Co., Inc., Amityville, New York
label; Gold line label; Class Ill; Product is contaminated with yeast, &
complaints of swollen containers were received
Doxycycline Hyclate Capsules, 1OOmg, 500-count bottles, Rx; Lot 2985-103511 EXP 12/04; 3,601, 500-count bottles distributed
Class Ill; Active ingredient fails to meet test specification for related nationwide; lvax Pharmaceuticals, Inc., Miami, Florida
compounds
Levoxyl Tablets, 50 meg, and 100 meg, Rx; Class II; Product from Product codes 5297-Q, 5297-1, 5300-Q; 13,82D-100 meg tablets,
manufacturer lacks stability prior to expiration date (subpotency and 18,600-50 meg tablets distributed nationwide; Allscripts Healthcare
super potency) Solutions, Libertyville, Illinois
Lomotll Tablets (diphenoxylate hydrochloride, 2.5 mg and atropine Lot Number: 021245, EXP 4/17/04; 1,288 bottles of 100 tablets dis-
sulfate, .025 mg), 100 tablets, Rx only; Class II; Tablets supplied' by tributed nationwide; G. D. Searle & Company, Chicago, Illinois.
the manufacturer may contain metal particles Recalled by AmeriSource Health Services Corp., Columbus, Ohio
Lomotll Tablets, (diphenoxylate hydrochloride), Rx, bottles of 100, Lot Numbers C200511 and C200682 in 100 tablet bottles; Lot
1,000, 2,500, and unit dose cartons of 100; Class II; Tablets may con- Numbers C200195 and C200577 in 1,000 tablet bottles; Lot Number
tain metal particles C200363 in 2,500 tablet bottles; Lot Number C200360 in 100 tablet
unit dose carton; 9,720 bottles and cartons distributed nationwide;
Pharmacia Corp., Kalamazoo, Michigan
Premarln Tablets (conjugated estrogens tablets) 0.625 mg, Rx; Lot Numbers: 9001566, 9010254, 9010255, EXP 07/03, 9010509,
Class Ill; Failure to meet dissolution specifications 9010510, EXP 10/03; 47,024 bottles of 100; 9,255 bottles of 1000;
and 1,408 bottles of 5000 distributed nationwide; Wyeth-Ayerst
Laboratories, Richmond, Virginia
Tamiflu Capsules (oseltamivir phosphate),75mg, 10 capsule car- Cartons of 10 capsules 81022-Q1, 81023-01, 81024-01, 81025-01,
tons and 15 x1 capsule Professional Samples, Rx only; Class Ill; 81025-Q2 EXP 6/02. 81029, 81029-01 EXP 9/02. Physician Samples
Potential cross contamination with active ingredients which could (15s) B1025-Q3 EXP 6/02; 1,021,141 trade lots; 1,800 free goods;
include mefloquine, levodopa/benserazide, .and/or sulfamethoxazole 153,264 physician samples distributed nationwide; Roche
Laboratories, Nutley, New Jersey
4 +August 2002
D R U G S A N D D I E T A R Y S U P P L E M E N T S cmtt.
Name of Drug or \upplemeut; C/a.H of Recal~· Problem Lot #; Quautity ami Distribution; M.mmfacturer
Tri-Nasal Nasal Spray {triamcinolone acetonide), 50 meg {0.05%), Product code: 5050-15 and 5050-00; 377.742 distributed nationwide;
120 metered sprays, 15ml bottles and professional samples, Rx; Muro Pharmaceutical, Inc., Tewksbury, Massachusetts
Class Ill; Subpotent, potency of the active ingredient triamcinolone
acetonide cannot be assured through labeled expiration date
MEDICAL DEVICES
Device recalls are classified in a manner similar to drugs, Class I, II or III, depending on the seriousness of the risk pre-
. sented by leaving the device on the market. Contact the company for more information. You can also call the FDA's
Device Recall and Notification Office at (301) 443-4190. To report a problem with a medical device, call 1-800-FDA-
1088. The FDA web site is http://wwwfda.gov.
Name (~l De1•ice; Class oj ReL·afl; Pm/Jiem Lot#; Quantity anti Distribution; M.muifacturer
lnterplak Power Plaque Remover Toothbrush; Class II; Batteries Model number 12209W; 15,758 units distributed nationwide; Conair
leaking hydrogen gas during charging popping off the end cap Corp., East Windsor, New Jersey
CONSUMER PRODUCTS
Contact the Consumer Product Safety Commission (CPSC) for specific instructions or return the item to the place of
purchase for a refund. For additional information from the Consumer Product Safety Commission, call their hotline at
1-800-638-2772. The CPSC web site is www.cpsc.gov.
Name of Prmluct; Problem Lot #; Quaulily ami Distrilmtion: M.muifacturer
Adapter Plugs (International}; Plug can separate when the plug is 2-prong slip-on; 22,000 sold nationwide from November 2000
removed, exposing live electrical conductors, posing an electric shock through March 2002; PM International Ltd., Edison, New Jersey
or electrocution hazard (800) 377-6332
Cigarette Lighters; May have child-resistant mechanisms that do Disposable, metal, with top that resembles a pencil across a protractor
not meet federal safety standards and triangle; 1,800 sold nationwide from December 2000 through May
2001; L.A. Lighter Inc., Azusa, California (800) 499-4708
Cigarette Lighters; Lighters do not have child-resistant mechanisms Refillable liquid or gas fueled with various decals; 6,000 sold in north-
ern California from March 1999 through April 2002; Specialty Sales
Co. Inc., Castro Valley, California (510) 581-3869
Drip Pans; Hot burners can ignite the pans and pose a fire hazard Various sizes SKU 845289; 294,000 sold at Dollar Tree Stores nation-
wide from April through May 2002; Dollar Tree Stores, Inc.,
Chesapeake, Virginia (800) 876-8077
Electrical Paintings; Paintings can short circuit, posing a shock or Motion Picture Series painted on glass, illuminated by a light bulb;
fire hazard 150 sold at flea markets in Texas and Arkansas from December 2001
through April2002; UL United Inc., Houston, Texas (866) 332-6643
Emergency Escape Smoke Hoods; Consumers may have pur- EVAC-UB bright green plastic with clear red top; 27,400 sold by web-
chased the hoods for protection from tear gas or chemical warfare based distributors, catalogues and travel stores from May 1997
agents, but should be used only to provide protection from smoke through April 2002; Brookdale International Systems, Inc., Vancouver,
caused by fires British Columbia, Canada {800) 459-3822
Public Citizen's Health Research Group + Health Letter + 5
C 0 N S U M E R P R 0 D U C T S emil.
Name of Pr(){/uct; Problem Lot #; Q11tmtity a11d DistriiJution: Jlmmfacturer
Ice Shavers; Stainless steel blade can cut consumers and cause Orange and blue with palm tree design; 1,000 sold nationwide
injury throughout May 2002; Bath & Body Works Inc., Columbus, Ohio
(800) 395-1 001
Instant Hot Water Oispensers; Water can leak from the metal Various brand names with serial numbers 999-10 or between 1000
holding tank, wet insulating material and cause electrical arcing and and 3084000; 252,000 half-gallon units sold nationwide from January
heat build-up, posing a fire hazard 1972 through December 1996; ln-Sink-Erator, Racine, Wisconsin
(800) 295-8727
Little Wooden Push Cars, Recall to Repair; Achild can pull the Natural wood, 24 inches long with "Radio Flyer" written on sides;
horn off the car's steering wheel, and a small part inside poses a 15,000 sold nationwide from February 1999 through June 2002;
choking hazard Radio Flyer Inc., Chicago, Illinois (800) 621-7613 www.radioflyer.com
Mountain Bicycles with "Ballistic 105" front suspension forks; Can Next Ultra Shock with Ballistic 105 front suspension forks, blue;
break apart, causing riders to lose control 132,000 sold at Wai-Mart stores nationwide from May 1999 through
December 2000; Dynacraft Industries Inc., San Rafael, California
(800) 288-1560 www.dynacraftbike.com
Pop 'n Scoot Ride-on Toys; Young children who lean forward can Molded plastic with clear dome filled with beads, model1568-01:
fall forward over the handlebars, causing injury 21 ,400 sold nationwide from March 2001 through May 2002; The
Little Tikes Company, Hudson, Ohio (866) 765-6729
www.littletikes.com
Potpourri Simmering Pots; Flames from candles inside these pot- Six-sided white ceramic, sold under the Martha Stewart Everyday
pourri pots can flare out of the side ventilation holes, possibly causing Brand; 80,000 sold nationwide from September 2001 through March
burns to consumers 2002; Candle-lite, Cincinnati, Ohio (800) 718-7151
Propane Heaters; Heaters can emit high levels of carbon monoxide Model 883-1000-0 outdoor tabletop; 45,000 sold nationwide from
(CO), which poses a risk of CO poisoning to consumers September 2001 through May 2002; The Brinkmann Corporation,
Dallas, Texas (800) 675-5301
Stove Fuel; Corrosion can cause the can to leak fuel, posing a fire or Packaged in red metal cans, batch number 2003-2; 9,700 cans sold
injury hazard nationwide from March through June 2002; Mountain Safety
Research, Seattle, Washington (800) 531-9531 www.msrcorp.com
Toy Tracks attached to children's activity centers; Toy track can break, Tot Wheels V models 4511 and 4521 and Convertible Entertainer
presenting a cut or pinch hazard and exposed small parts pose a models 4562 and 35225; 152,000 sold nationwide from November
choking hazard to young children 2001 through May 2002; Graco Children's Products, Inc., Elverson,
Pennsylvania (800) 673-0392 www.gracobaby.com
Washer and Gas Dryers; Dryer can overheat, posing afire hazard Whirlpool, Kenmore and General Electric brands, numerous models;
17,000 sold nationwide from January 2000 through May 2002;
Whirlpool Corp., Benton Harbor, Michigan (866) 251-1607
www.repair.whirlpool.com
6 +August 2002
Is Your Doctor Selling You to the Highest Bidder?
ntil relatively recently,. human accepting payment for referring
U experiments to determine
whether or not drugs work as
intended were deemed too complex
Physicians are
patients to research studies (finder's
fees) is also unethical." A companion
organization in Britain, the Royal
College of Physicians, requires that
to entrust to non-academic physi-
cians. But things progress slowly in
frequently offered recruitment fees be disclosed to
the groves of Academe, and pharma- research ethics committees.
ceutical company executives of late
thousands of dollars But as Drs. Rao and Cassia point
out, patients also have a right to
have come under 'increasing pressure
from stockholders for ever-larger div-
in (finder's fees" know about these sometimes shady
idends. As a result, the focus of fiscal arrangements. "Not to require a
experimental medicine is moving similar disclosure to patients is as
away from the bureaucratic, stodgy cynical as it is demanding of blind
campus environment to venues the industry than to true scientific and unquestioning trust." Moreover,
where studies can be completed progress. (Many of these drugs aren't while modestly reimbursing physi-
more rapidly. Increasingly, industrial blockbusters at all, offering little or cians for research-related services
sponsors of new products are turning no advantage over existing, cheaper, rendered beyond what would ordi-
to private practice physicians' offices generic drugs-but that is another narily be provided to the patient is
for research subjects. story.) "A system that allows com- acceptable, trial sponsors and parti-
But how to recruit research sub- mercially driven and clinically dubi- cipating physicians can circumvent
jects from private practices when ous research to crowd out good and any restrictions by "claiming to pay
doctors are already swimming in a much needed clinical trials, and that for the work involved in conducting
sea of clinical work and insurance denies patients their opportunity to the trial (rather than for recruiting
company forms and procedures? In a put their altruism to the best possible patients), and then overestimating
society where everything (and, use," say the doctors, "is unethical the amount of time required for each
apparently, everyone) is a potential and unacceptable." patient."
commodity, can it be any surprise Even if the research is legitimate, As usual, patients are ahead of
that the solution favored by the phar- finder's fees are improper. As ques- physicians on this issue. In a 1995
maceutical industry is-you guessed tionable a guardian of medical ethics U.S. survey, approximately 90 per-
it-the almighty buck. Physicians are as the American Medical Association cent of patients thought they should
frequently offered thousands of dol- declared in 1996 that "[o]ffering or be told who paid for the study, 80
lars in "finder's fees" merely for percent wanted to be told if the
plumbing their patient lists for eligi- researcher owned stock in the com-
ble patients and then referring them pany, and 85 percent wanted similar
to the industry as potential subjects. Approximately disclosure if the investigator was
paid for each patient enrolled. For
An article in the British Medical
journal raises serious questions 90 percent of patients each of these questions, doctors rec-
ommended disclosure at somewhat
about these practices. As Drs. Jammi
Rao and Sant Cassia point out, "cash thought they should be lower rates. Similar disparities are
apparent when doctors and patients
payments can influence doctors'
motives for joining a clinical trial." told who paid for are asked about the appropriateness
of accepting knickknacks, free meals
Worthy research (and clinical care)
can be displaced by more remunera- the study and trips to exotic locations from the
pharmaceutical industry. When will
tive drug company funded research,
often dedicated more to the creation the doctors catch up with their
of the blockbuster drugs sought by patients?
Public Citizen's Health Research Group + Health Letter + 7
Hormone Replacement Therapy
In a book Public Citizen's Health es, heavy sweating and vaginal dis- they cause human breast cancer, you
Research Group book published 11 comfort. For the short term problems will probably be told the evidence is
years ago, Women's Health Alert, the associated with menopause these still "inconclusive" and "inconsis-
largest chapter was on hormone women began hormone replacement tent," or that women are not the
replacement therapy (HRT'). By then, therapy. However, while the symp- same as rats or mice.
the evidence was clear that these toms of menopause usually subside You may have heard or read that
drugs caused breast cancer, very seri- in less than two years, a large pro- if you take menopausal hormones
ous doubts had been raised about portion of these women will take you increase your risk of endometri-
their ability to protect against heart estrogens, and probably progestins al (uterine) cancer, heart disease,
disease, and safer alternative drugs (a synthetic form of the naturally stroke, gallbladder disease, uterine
had been developed for osteoporosis. occurring female replacement hor- fibroids, liver disease, and migraine
The first sentence in this chapter mone progesterone) indefinitely. headaches. If you combine estrogens
began: "Female replacement hor- By today's questionable medical with progestins, you will reduce your
mones may someday be remembered reasoning, these potent drugs should risk of uterine cancer, but may simul-
as the most recklessly prescribed and be given to perfectly healthy taneously be increasing your risk of
dangerous drugs of this century." women, not to treat any disease, but heart disease and breast cancer.
Since the chapter was written, to decrease the potential of dis- Progestins may also cause abdominal
more and more evidence has accu- ease-specifically osteoporosis and bloating, headaches, depression, or
mulated linking these drugs with heart disease. acne. You may also begin to men-
breast cancer and disproving the Replacement hormones were the struate again.
protective effect on heart disease. This "feminine forever" drugs of the Many women do not realize that
has culminated in the study pub- 1960s and 1970s, guaranteed to keep menopausal hormones are grossly
lished in july from the government- wrinkles away, hair glossy and overprescribed for extraordinary
funded Women's Health Initiative depression to a minimum. In the lengths of time-now longer than
proving, beyond doubt, that the 1980s, these drugs were advertised ever before-longer than anyone
drugs do indeed cause breast cancer as the cure for osteoporosis, the long can scientifically justify. Unless you
and, instead of protecting against sought-after answer to brittle bones. are considered at high risk for poten-
heart disease, actually increase the Now in the 1990s, estrogens are tial problems with the treatment,
risk of strokes, heart attacks and being touted as the solution to physicians today are more likely to
blood clots. female heart disease. Whatever their downplay any harm and persuade
Below are excerpts from the 1991 mission, these recycled wonder you that without them you will pre-
Women's Health Alert chapter on drugs have securely found a perma- maturely expire or snap under the
HRT. nent spot in the medicine cabinets of weight of old age.
millions of healthy women over 45. Prescription practices for these
ince the 1940s when estrogens But the dangers of hormone replace- potent drugs have subtly but dramat-
S were first manufactured cheap-
ly and available by mouth, the
story of their widespread use in
ment therapy have been tragically
underplayed by American doctors,
the press, and of course the drug
ically shifted over time. Today, it is
not up to women to prove they
need hormone replacement after
treating women's "problems" is one companies, who make hundreds of menopause. The burden is on
of false promises, disregard for sci- millions more dollars every time a women to prove they don't. So wide-
entific evidence and the wishful new use for these drugs is found . spread is the use that many women
thinking of women and their doctors Throughout the history of their may not be completely sure why
that all female health problems can application in American medicine, they are still taking estrogens at age
vanish with the magic of pills. It is a estrogens have proven to be as dan- 60.
story of well-meaning doctors eager gerous as they are helpful. As with These two grandmothers are
to please, and of women too easily so many medical products sold to examples:
sold the wonders of pharmaceutical American consumers, taking them
cures. Unfortunately, years after has become a risk-benefit game; the I have been taking estrogens since
women have been routinely con- difference here is that women are I can remember. I don't know
suming hormones, many of these not making choices based on all the whether I'd still get hot flashes, but
otherwise healthy people have slow- facts. I don't want to find out.
ly been getting sick from estrogens. Ovarian hormones, especially and
In 1989 more than 3.5 million estrogens, have been linked to breast I started taking estrogens 12 years
women were given estrogens for the cancer in animal studies since the ago when my surgeon prescribed
symptoms of menopause-hot flash- 1930s. But if you ask your doctor if them following my hysterectomy. I
8 +August 2002
was having terrible hot flashes macologic interventions are power- were 2.7 times as likely to develop
then, and Premarin (the most ful symbols of the triumph of med- breast cancer 10 years after starting
widely prescribed estrogen) com- ical technology. Patients are likely to drug treatment as women who did
pletely got rid of them. I'm still tak- believe implicitly that the benefits of not use the drug.
ing it, because somewhere along drugs clearly outweigh the risks." In the second study, researchers
the line, I don't remember when, This can be a very dangerous found that women who received any
my doctor told me they would pro- assumption. dose of menopausal estrogens for at
tect me against osteoporosis. I feel least seven years had an 80 percent
great and don't see a reason in the Cancer and Hormone increase in breast cancer.
world I should stop taking that pill Replacement Therapy The 1981 study found that women
along with my vitamin every day. In the United States in 1990, an who had surgical removal of the
estimated 150,000 new cases of ovaries and estrogen replacement
Hormones: Not Harmless Little breast cancer will be diagnosed in therapy increased their risk of breast
Tablets women and 44,000 women died of cancer; dramatically the longer they
Little pills that deliver hormones the disease. Because women of the were on estrogens. The risk worked
to your body are not simple vitamins "baby boom generation" are now out like this: in less than five years of
or candy-coated aspirin. They are reaching age 40, the number of estrogen replacement therapy these
manufactured duplicates of sub- breast cancer cases and deaths will women had a 38 percent increased
stances that play amazingly diverse increase substantially over the next risk of breast cancer; at nine years,
roles in females. Besides their role in 40 years. For this reason, even a their risk had increased to 55 per-
maintaining reproductive cycles, small increase in the risk of breast cent; and after 10 years it reached 70
estrogens alter lipid (fat) levels, cancer caused by menopausal estro- percent.
metabolize carbohydrates, affect gens will translate into a lot of lost In 1986, an expanded study of
how blood coagulates, adjust blood lives. menopausal estrogen use showed
pressure, and assist in calcium As women in menopause by the that 20 years after first using estro-
absorption, all of which are complex hundreds of thousands are being gens, women had increased their
biologic events. given replacement hormones, that risk by 50 percent.
When the natural supply of increased breast cancer risk is being But all these findings have been
estrogen slowly diminishes after further investigated now. But accu- called "inconclusive" because other
menopause, can its job all be mulated evidence over the past studies have shown little or no con-
"replaced" in a pill? decade shows that if you use nection between breast cancer and
Obviously not. The enormous and menopausal estrogens for a long menopausal hormones. Proponents
complicated functions of hormones time, you roughly double your of menopausal hormones are reluc-
are not completely understood by chance of getting breast cancer by tant to implicate this wonder drug
science. Experts are still exploring the time you are 75. as a contributor to breast cancer,
the effects-both good and bad-of What's a long time? Let's briefly an admittedly complicated disease
replacement hormones. There is still look at the scientific studies. While caused by many factors.
a lot to know about their long term they go back earlier than this, the In 1989 at a meeting of the Food
risks, since long term use is relative- first reliable studies of women taking and Drug Administration Fertility and
ly new. In fact, identifying which menopausal estrogens for longer Maternal Health Drugs Advisory
women will ultimately benefit from than five years were published Committee in Washington D.C. lead-
these drugs is still impossible, which between 1977 and 1983. These were ing researchers met to decide if the
is why their use is so general and strikingly consistent in their findings, evidence over the last decade did
widespread. There is an excellent and overall, showed that women indeed point to an increased risk of
probability that the vast majority of using the most commonly prescribed breast cancer in postmenopausal
women receiving hormone replace- dose of estrogen (1.25 mg tablets at women.
I
ment therapy will obtain no benefit the time) for five or more years dou- Janet Daling from the Fred
at all while subjecting themselves to ble their chance of developing breast Hutchinson Cancer Research Center
all the potential risks and side cancer. in Seattle called the question of risk
effects. Four of the five studies found that "very tricky" to answer: "My conclu-
Since ovarian hormones have the risk of breast cancer was highest sion would be that estrogen replace-
been known to promote cancer, the in women who used higher doses of ment therapy may have a modest
trend toward grossly overprescribing the drug, women who used the drug effect on breast cancer risk, some-
them can't be taken lightly. As Allan for a long period of time or both. In thing in the range of 1.5 to 2.0 [times
S. Brett a researcher from the New the first of these studies, researchers increased risk] in women who have
England Deaconess Medical Center found that women using doses high- used estrogens for long periods of
wrote in a 1989 editorial in the New er than .625 mg per day (the dose time."
England journal of Medicine, "phar- most commonly prescribed today) The committee was also asked to
Public Citizen's Health Research Group + Health Letter + 9
review all the evidence and their Institute, says the results shouldn't associated with menopause. Hot
conclusion was: "The committee's make any hormone proponent feel flashes are temporary changes most
unanimous response is, while the vindicated. "It looks as though the women encounter. However, many
evidence is not conclusive, some cancer risk may be an estrogenic other psychological conditions have
studies have reported an increased effect and not some nuance of the been described as "symptoms" of
risk of breast cancer in long term use chemical structure of different estro- menopause. Irritability, depression,
of estrogen replacement therapy." gen compounds." anxiety, loss of sexual feelings, and
Today, instead of getting only a an almost limitless list of other states
prescription for estrogens, you will The results of the Swedish study, are all attributed to it, but not
probably also get another little bottle, says Hoover, are not surprising. proven to be caused by it.
this one with progestins. You will Menopause is not the first time
take these for 7 to 10 days at the end The fact that ovarian hormones most women experience these symp-
of your cycle of estrogen pills. might relate to increased risk of toms, but they may be worsened at
In the mid-1970s, three striking breast cancer is not on the bizarre age 45 or 50 in a society that dis-
studies found that taking estrogen by fringe of biological reasoning. The criminates against aging women, pro-
itself increases your risk of endome- biological plausibility was estab- motes superficial notions of exclu-
trial or uterine cancer from 5 to 14 lished 100 years ago, so new data sively youth-related sex appeal and
fold. This news sent shock waves which shows that women on encourages everyone to answer all
through the medical community, but replacement therapy have an problems with a pill. Menopausal
in 1989 it was shown that by adding increased risk is exactly what you estrogens will not eliminate wrinkles,
progestins, the problem of endome- would predict. You can argue increase your libido, or ameliorate all
trial cancer was largely ameliorated. about what level of risk there is, the psychological conditions that
but the reasonableness of the come with growing older. Those
Good news and bad news. It was observation is firmly steeped in hoped-for effects don't happen, plain
somehow "hoped" by some doctors biology. and simple.
that progestin would also offer However a small number of dis-
women some protection from breast Arguing about the level of risk is ruptive and annoying symptoms of
cancer, despite the known differ- what researchers are doing these menopause may be alleviated by
ences between how each organ days, which may be the reason that reintroducing estrogen as its own
responds to hormones. However, not practicing physicians are told, and production is slowly reduced.
surprisingly, in the summer of 1989, will tell you, that studies are incon- Menopausal estrogens in low doses
a new study from Sweden suggested sistent and inconclusive, so basically over short periods can eliminate hot
that progestins in combination with there is nothing to worry about. In flashes and night sweating associated
estrogen may cause more harm than fact, if you increase your risk of with menopause. They can also
good. breast cancer, that is obviously some- reduce vaginal dryness. While useful
The study showed, once again, thing to worry about. for both problems, treatment seldom
that women using estrogens alone needs to continue for longer than
for an extended period double their Getting Started on Replacement several months. Most women are
risk of breast cancer, but it also Therapy free of hot flashes in under two years
showed that when progestin was Why have women adopted the and vaginal dryness can be treated
added there was no protection notion that menopause is a cruel with topical creams.
against breast cancer. Instead, the consequence of being female, "one While some women do experi-
few women who used the two hor- of nature's mistakes," an illness that ence hot flashes that are incapacitat-
mones together for more than six needed to be cured? Menopause is ing, more frequent is the experience
years had a higher risk of breast can- not a disease. No one has ever died of Dorothy, 50, a psychologist.
cer than those taking estrogen alone. from it. It is a natural event that
The study has been criticized results in some temporary and some The first time I felt one I thought I
because the Swedish women who permanent changes for all women. bad forgotten to turn on the air
participated in it were given differ- Physiologically it's the time when a conditioner. Now I can feel one
ently manufactured hormones at dif- woman's ovaries stop functioning, coming and I know it's going to
ferent doses than women typically a process that can take several last a minute or so. Occasionally I
get in the U.S. But one of the study's years. The cessation of periods and have to take off a sweater, or wipe
authors, Dr. Robert Hoover, Chief of the thinning and drying of the my brow but it never gets in my
the Environmental Epidemiology vaginal tissues are among the two way. It's simply not a big problem.
Branch of the National Cancer most obvious permanent changes
10 +August 2002OUTRAGE, from page 12 than the blatant pitch "It's Botox under its roof, Public Citizen sent a
ties. In an April 29, 2002, letter to all Night at Hopkins." It is hard to imag- letter to Edward D. Miller, M.D.,
Academy members, Dr. Fred F. ine a patient education seminar on Chief Executive Officer and Dean of
Castrow II, the Academy's president, arthritis with "on-the-spot Enbrel the Medical Faculty at Johns Hopkins
cautioned dermatologists that "Social injections" or a seminar on cancer School of Medicine, strongly urging
gatherings of this kind in combina- with "on-the-spot chemotherapy." that "Botox Night" be cancelled.
tion with botulinum toxin treatments Whereas the refreshments and "With all the medical problems fac-
are inappropriate and potentially ing the U.S., and Baltimore in partic-
dangerous settings for patients. As ular, can this be the most productive
such, I strongly discourage you from use of faculty members,' students,' or
·participating in these kinds of med- ~ny interested in residents' time?" Public Citizen asked.
ical/social activities. " "What social or medical purpose is
Thus, we were astounded when receiving Botox serVed by marketing cosmetic proce-
we heard that everyone with an dures to healthy Johns Hopkins
email account through the Johns treatments may do employees, particularly those who,
Hopkins School of Medicine (includ- based on their age, will have few
ing students, faculty, residents and so on the spot!" signs of aging? Botox injections are
staff) had received an announcement medical procedures that should be
on Johns Hopkins stationary for the delivered in a calm, private setting-
Botox event with the title "It's Botox not in the festive atmosphere this
Night at Hopkins." Here was the announcement appeared to contem-
pitch: attendance at the session were plate."
indeed free-of-charge, as advertised, The Public Citizen letter had
Do you have fine lines and wrin- injections were to be offered to immediate results. Although Botox
kles that make you look older prospective clients at a special rate Night was not cancelled, the
than you really are? Do you want of about $100 per treatment. University did call off its plan to
to look younger without the cost Presumably, this "introductory offer" administer Botox at the event. It also
and inconvenience of surgery? would entice them to return to informed us that the university is
Curious what all the fuss is about Hopkins for injections in a few drafting an institutional policy which
Botox? Come join us after work months when the initial treatment will preclude similar events in the
for an iiifomation (sic) seminar inevitably wears off. The full price, future.
including live demonstration of typically five times that of the initial Such gatherings, which market
the many uses of Botox. Any treatment, most likely would be products under the guise of educa-
interested in receiving Botox treat- charged for subsequent visits. tion, undermine the core educational
ments may do so on the spot! Dismayed that a respected institu- mission of the university, debase the
Refreshments will be served and tion like Johns Hopkins would per- profession, and misdirect precious
attendance is free. (Emphasis in mit so inappropriate an activity health resources that would be better:
original) spent treating disease than pandering
to vanity. For this reason, Public
The wording of the ad did not Citizen has written to the Association
suggest an educational seminar so of American Medical Colleges asking
much as a sales pitch dressed up to The wording of the ad that it develop a national policy ban-
look like an educational event. Real ning such blatant commercialism. As
educational events at hospitals typi- did not suggest an for Johns Hopkins, in instituting its
cally occur at lunchtime seminars or planned policy prohibiting future
as grand rounds, not after hours with educational seminar so Botox Nights, it may yet lead the
promises of drugs for the attendees. nation, not only in medical science,
A truly educational seminar would much as a sales pitch but also in the fight to preserve
have been entitled "The Safety and integrity in medicine.
Efficacy of Botulinum Toxin A in the
Treatment of Glabellar Lines," rather
Public Citizen's Health Research Group + Health Letter + 11OUTRAGE OF THE MONTH
"It's Botox Night at Hopkins"
or the 12th consecutive year, of Facial Plastic and Reconstructive
F johns Hopkins Hospital has
come in first in the U.S. News &
World Report ranking of American
The American Academy
Surgery conducted between january
and April 2002.
Although alcohol was not served
at the johns Hopkins event, one pur-
hospitals . Ironically, one day before
receiving this honor, Hopkins came
of Dermatology went pose of the party setting is to capi-
talize on the fact that people in large,
within a hair's breadth of disgracing
itself by sponsoring a "Botox Night",
on record criticizing casual settings get caught up in the
moment and are easily influenced by
in which healthy people would have
received on-the-spot treatments at
Botox parties. persuasive speakers. Another is that
reduced prices in a social setting. since a vial of the very expensive
Botox, also known as botulinum Botox typically contains enough
toxin A, is a chemical that, injected toxin for five injections and the con-
in small concentrations, reduces the United States, typically in spas or tents must be discarded within four
ability of muscles to contract, there- upscale private homes, often featur- hours of the vial's being opened,
by causing improvement in the ing alcohol and on-the-spot injec- there is an incentive to gather
appearance of "glabellar lines" tions with Botox. The procedure enough people to use all the con-
(frown lines between the eyebrows). must be repeated, usually every tents in one session.
Since (and even before) the three to five months, potentially pro- just two weeks after Botox was
approval of Botox Cosmetic by the viding a steady stream of patients approved for cosmetic uses, the
Food and Drug Administration (and income). The average cost of a American Academy of Dermatology
(FDA) on April 12, 2002, Botox par- Botox injection is $497, according to went on record criticizing Botox par-
ties have sprung up all over the a survey by the American Academy continued on page 11
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12 +August 2002You can also read
