8
WEDNESDAY, DECEMBER 1, 2004
Social Security plans debated
BY MARK PUENTE
STAFF WRITER
Supporters of President Bush's
Social Security plan say many
young taxpayers could receive a late
Christmas gift from the nation's top
executive if he fulfills his campaign
promise of revamping the system.
Bush plans to give young adults
the option to choose among retire
ment plans by allowing workers to
divert a portion of their payroll taxes,
which now fund the program, into
accounts filled with mutual funds or
other investments.
But the president faces a variety
of problems in getting anew plan
through Congress.
Democrats oppose the proposal,
calling it an irresponsible use of the
nation's money. The costs could be
high. And the proposal is political
ly volatile because of its economic
implications for taxpayers.
The Social Security system is in
dire need of repair with millions
of baby boomers getting ready to
retire. Economists predict that
in 2018, Social Security will start
spending more money than it takes
in —and that by 2042, the govern
ment will have depleted the Social
Security TYust Fund.
“Social Security reform is not an
option,” said Michael Thnner, direc
tor of health and welfare studies at
the Cato Institute, a Washington
D.C.-based libertarian think tank.
“It has to be done.”
On the campaign trail, Bush
called for legislation allowing
young workers to put a portion of
their payroll taxes into personal
investment accounts. But he has
not offered a detailed plan on how
to divert the funds that now pay for
the retirement program.
Administration officials say it is
too early to speculate which plan
the president will adopt
Bush wants to give young people
a stake in their own retirement,
said Chad Kolton, press secretary
ORTHO EVRAP
(NORELGESTROMIN / ETHINYL ESTRADIOL
TRANSDERMAL SYSTEM)
PHetra *UJ Ire exMnwted tret tier produd down* pi o*ctg*nrHV intec
•an (NOS) and afar sexuaHy tammttM dmn.
ffconly
ORTHO EVRA® is a combination transdermal contracepttw patch with a contact surface area
of 20 cm 2. It contahs 6.00 mg norelgestrom n and 075 mg ethinyl estradiol (EE), and releases
150 of noreigestromin and 20 micrograms of EE to the bloodstream per 24 hara
•WOST/Uff NOTE-TNe information is a BRIEF SUMMARY of the complete prssaWng
Internet) oil provkted with the product and therefore should not be used as tie bads for
prescribing the product Tide eummeni erne prepared by deleting fromtheconnpletepre
eateng alternation certain test tables and references. The phystctanstnM be thoioughly
Write esMhlte conflate prsacitibiflbrfoiTnattei botes prescribing product.
WHCXnONS AND USAGE: ORTHO BRA® is indicated lor the preventksi of pregnancy.
Lite oral contraceptives. ORTHO BRA® is tnghfr effective I used as recommended in this tebel
auwo FW4* baa not tmn studied tor end Is not InKceted tor tm Hi emergency
CSNTRAMDICAnONSt ORTHO EVRA® shout! not be used in women who aarently have the
folowng conditions: 1. Thrombophteblis. thromboembolic disorders 2 A past history of deep
veei thrombophlebitis or thromboembolic disorders 3. Cerebrovascular or coronary artery
disease (current or pest history) 4. Valvular heart disease wlh complications 5. Severe hyper
tension 6. Diabetes with vascular itvolvement 7. Headadtes with focal petrological symptoms
8. Major surgery wlh prolonged im mobiteation 9. Known or suspected carchoma of the breast
or personal history of breast cancer 10. Cucriona of the endometrium or other known or
suspactedectrogen-dapendenlneoplasiall.UndiagTocedatncrmal genital Ueedhgl2. Cholestatic
jaundice of pregrancy or jaundice wjlh prior hormonal contraceptive use 13. Acute or chronic
hepatocellular disease with abnormal liver finction 14. Hepatic adenomas or carcinomas
15. Known or suspected pregnancy 16. HjpersenstMty to any component and Iris product
WMMMQS
Cigarette smoking Increases the risk of serious canlloyescutat MOv effects
from hormonal contaecapttveuee.TNs risk Increases wtti age and with heavy
snaking (15 or more cigarettes per day) and la quite merited In woman
osar 36 years or age. Woman who me hormonal contraceptives. Including
OHTHO EVRA®, should be shotttfy advtsed not to smoke.
ORTHO EVRA® and Mher contraceptives that contain both an estrogen and a progestin are
called combination hormonal contraceptives. There is no epidemiologic data available to
determine whether safety and efficacy with the transdermat route of administration would be
dtfteent than the oral route. Practitioners presenting ORTHO BRA® should be famliar wtth
Pie following information relating to risks.
The use ol combination hormonal contraceptives is associated with increased risks of several
serious conditions Including myocardial infarction, thromboembolism, stroke, hepatic
neoplasia, and galtHadda- disease, although the risk ol serious morbidity or mortality Is very
small h healthy women without underlying risk factors. The risK of moibldly and mortality
Dcreases significantly h the presenoe of other undertyng rfck factors such as hypertension.
hypertfldemla6, obesity and diabetes.
The Wormation contaned n the package risen is principally based on studies carried out n
women who used combination oral contraceptives with higher formulations of estrogens aid
progestins than those it com men use today. The effect of long-term use of combbatkn
hormonal contraceptives with lower doses of both estrogen and progestin admhistered by uiy
route remans to be determned.
Thratfwit this tabethg, epidemiological studies reported are of two types: retrospective or
case control studies and prospective or cohort studies. Case control studies provide a meas
ure ol te relative risk of a disease, namely, a ratio ot the incidence ol a disease among oral
contraceptive users to that among nonusers. The relative risk does not provide intamatton
on the actual clinical ocarence of a disease. Cohort studies provide a measure ot attributa
ble risk, which is the inference In the incidence of disease between hormonal contraceptive
users and nonusers. The attributable risk does pwide information about the actual occur
rence <* a disease n the population (adaptedfrom rets. 2 and 3 with the author’s permission).
For further Mormatkm, the reader is referred to a text on epidemiological methods.
1. Thremboentbolc Dteorden And Odter Vascular Problems: a. Thromboembolteit H\
increased nek ot thromboembolic and thrombotic disease associated with the use of hormcnal
contracepthes is well established. Case control studies have found the relative risk of users
compered to nonusers to be 3 for the first episode of superficial venous thrombosis, 4 to 11
for deep vain thrombosis or pulmonary embolism, and 1.5 to 6 tor women with predisposng
conditions for venous thromboembolic disease. Cohort studies have shown the relative risk to
be somawhat lower, about 3 for new cases and about 4.5 lor new cases requirtrn hospteliza
ttev The risk of thromboembolic disease associated with hormonal contraceptives is not
related to length ol use and disappears after hormonal contraceptive use a stopped. A two- to
four-fold increase it relative risk of post-eperative thromboembolic complications has been
reputed with the use ot hormonal contraceptives. The relative risk of venous ttrorrboss in
women who have predisposing ccnd Hons is twice that of women without such medical con
ditions. If feasbte, hormonal coitraceptivee should be discuitlnued at least lor weeks prior
to and lor two weeks alter elective surgery of a type associated with an increase n rtak of
Svomboembolism and durhg and following pooknged immobilization. Since the immediate
postpartum period Is also associated wh an increased risk of thromboembolism, hormonal
contracepttres should be started no earlier than four weeks after delivery h women who elect
not to breast-feed. In the Urge dnical trials (M= 3,330 with 1,704 woman-years ot erasure)
one case of non-fatalpuhionary embolism occured during ORTHO EVRA® use, tsxl one case
of post-operatke non-latal pulmonary embolism was reported followsig ORTHO EVRA® use. t
is unknown if the risk of venous thromboembolism with ORTHO EVRA® use S diluent thui
wi use of combination oral contraceptives. As with any combination humatal contracep
tives, the ctewaan should be alert to the Darkest manifestations of thrombotic disorders (ftvom
bophlebltis, pulmonary embolism, cerebrovascular disorders, and retrial thrombosis). Should
any of these occur or be suspected, ORTHO EVRA® should be discontinued immediately,
b. Myocardial Infarction: An ricreased risk of myocardial Infarction has been attributed to
hormonal contraceptive use. This risk is primsrily ri smokers or women wth othu underlyrig
risk lactus for cuonary artery disease such as hypertension, hypercholesterolemia, morbid
obesity, and dabetes The relative risk of heart attack ta current hormonal cmiraceptive users
has been estimated to be two to sk compared to non- usus. The risk Is very low under the age
ot3o. Smokrigricombhation with oral contraceptive use has been shown to contrtutescfr
stantiaHy to the incidence of myocardial Infuctions ri women ri ther mid-thirties or okter wth
smokrig accounting tor the majority of excess cases. Mortality rates associated with circuta
tory disease have been shown to hcrease substantial ri smokers. especa by ri those 35 years
ot age and okter among women who use oral contraceptives. Humeral contraceptives may
compand the effects ot weli-knovm risk factors, such as hypertension, diabetes hyperlpi
demias, age and cbesty. In particular, some progestns are known to decrease HDI choles
terol and cause glucose intobrance, while estrogens may create a state ot hypurisulmlsm.
Hormonal contrecertkes have been shown to ncrease blood pressure among some users (see
Secbcn 9 ri WARNINGS). Similar effects on risk factors have been associated with an increased
rkk cf heart disease Hormonal contraceptwes riduding ORTHO EVRA®. must be used w*i
caution in women with cardiovascular disease ri* factors. Norgestimate and norelgestromri
have mriimal androgenic activity (see CUN CAL PHARMACOLOGY in tul Prescribrig hfwmation).
There is some evidence that the ri* of myocardial Infarction associated with hormonal
contracaptkes is lowa when the progestin has minimal androgenic actkty that when the
activity is greater, c. Cerebrovascular diseases: Hormonal contraceptives have been ahown
to ncrease both the relative and attributable risks of cerebrovascular events (ttrombotic and
hemonhapic strokes), although, ri general, the ri* is greatest among older (>35 years)
hypertensive woman who also smoke. Hypertenskn was found to bea rkk factor lor both users
and nonusers, for both types of strokes, and stinking Interacted to increase the ri* of stroke
h a large study, the relative ri* of thrombotic strokes has been shown to range from 3 for
normotensive users to 14 for users with severe hypertension. The relative ri* of hemorrhagic
stroke is reported to be 1.2 tor non-smokers who used hormonal contraceptives, 2.6 for ent
ers who did not use hormonal contraceptives, 7.6 tor smokers who used hormonal contra
ceptives, 1.8 lot normotensive users and 25.7 for usus with sevue hypertension. The attributabte
ri* is also greater ri okter women, and. Dose -related rtek of vascular dlseaes from hormonal
oorrtraeepthra* Apostke association has been observed between the amouit ol estrogen
and progestin ri hormonal contraceptkes and the ri* ol vascuhr disease. A decline ri semm
Wgh-density Roprotens (HDL) has been reported with many proge6tetKnal agents. A decline
ri aerum high-density Ipoproteins has been associated wtth an increased incidence ot iechemic
heart disease. Because estrogens ncrease HDL cholesterol, the net effect ot a hormonal con
traceptke depends on a balance achieved between doses ot estrogen and progestin and the
activity ot the progestn used ri the contraceptives. The acbvty and amount of both hormwes
should be considered ri the choice of a hormonal contraceptive, a. Paratetance ol rtek of vas
cular dlsaastt There ue two studies that have shown persistence of ri* of vasculu disease
fa eva-ueers of combination homtonal contraceptives. In a study ri the Uhted States, the rkk
of devekflng myocardial enaction after disccntnuhg combination hormonal contraceptives
persists for at least 9 years tor women 40-49 years who had used combriation hormonal con
traceptkes fa five a more years, but this Increased ri* was not demonstrated ri othu age
groups, ri another study n Great Britan, the ri* of developing cuebrovasoular disease
persisted fa at least 6 years after discontriuation ot combriation humoral contraceptives,
abrafli excess rkk was veiy small. However, both stud iee were performed with combination
hormonal contraceptive famuiations contanhg 50 micrograms u hfltu of estrogens. It is
unknown whether ORTHO EVRA® is district from othu combination hormonal contraceptives
wih regard to the occuirence of venous and arterial thrombosis. 2. Estimates Of Mortality
From CanUnatlon Homtonal Contraceptive Use: One study gathered date from a variety
ol sources that have estimated the mortality rate associated with different methods of
for the White House Office of
Management and Budget
“It’s an important principle,” he
said. “The president believes having
ownership over their retirement
will make it viable in the future.”
But one pundit said revamping
a system that is sometimes referred
to as “the third rail of politics”
would be a challenge for any presi
dent or legislator.
For years, politicians have put
off changing the current system
for fear of alienating voters.
“If you touch it, you’ll die,” said
Jamie Carson, professor of political
science at the University of Georgia.
“But most people acknowledge it
needs to be revised.”
Retirement is not a topic that
many young people worry about at
an early age. Recent college gradu
ates are more concerned with the
immediate future of finding a
job and paying off student loans.
Planning for something 40 years
down the road is not a priority.
“We’re not suggesting they sit
down nightly with the Wall Street
Journal and choose between
General Electric and General
Motors’ stocks,” Tanner said.
All of the personal investment
plans being discussed would be
voluntary, and there would be no
access to the funds if a person fell
on hard times.
But Bush’s plan might create a
shortfall in the system, and bor
rowing by the government could be
necessary to establish the personal
accounts because of the way Social
Security' pays for benefits.
“If we pay a little now, we will save
a lot later,” Thnner said. “It would be
like paying your credits off today.
There are tough choices to make.”
Under the current system, the
payroll taxes levied on workers
provide benefits for people who are
already retired. Supporters of Bush's
plan say it would not affect retirees.
“We have a moral obligation to
contraception at diluent ages. Hiese estimates include frte combined ri* ot death associ
ated with contraceptive methods plus frier* attributable to pregnancy r the event ot method
tenure. Each method ol contraception has its specific benefits and rsks The study concluded
that with the exception ot combination oral contraceptke usus 35 and older who smoke, and
40 and okter who do not smoke, mortality associated wfrh ail methods ot birth control is low
and below that associated witi chldbirih.
The obseivation ot a possible increase ri ri* of mortality wth age for combinaticn oral con
traceptke users is based on data gathued ri the 1970's but not reported inti 1983. Cutrent
dnical recommendation Involves the use and tower estrogen dose tamulations and a cueful
consideration dri*tadore.lnl9e9theFeitilityand Maternal Health Drags Advisory Commttee
was asked to review the use and combriatiai hormonal contraceptkes h women 40 years and
age and over. The Commttee conctided that although cardiovascular disease risks may be
ricreased wth combriation hormonal contraceptive use alter age 40 h healthy non-smokrig
women (even with the never low-dose (emulations), thue are also greater potential heaKh
risks assocated wih pregnancy in okter women and with the altematke surgical and medical
procuteres rial maybe necessary it such women do nd have acceestoeffectke and acceptable
mears and ccrtreceflun The Committee recommended that the benelitsd tow-dose combi
nation himonal contraceptive use by healhynen-smokrig women over 40 may outweigh the
possible rteks. Although the date are mainty.obtaned with oral contraceptives, this is likely to
apply to ORTHO BRA® as wefr. Women and alt ages who use combriatiai hamonal contra
cetfkes, should usefrie lowest possible dose formulation that is effective and meets the ridn
viduat patient needs. 1 Cardnorra Of The Reproductive Organs And Breasts: Numerous
epidemiological studies give conttidrig reports on the relationshp between breast canca and
COC use. The rkk of having breast cancer diagnosed may be slightly increased among current
and recent users and combination oral contraceptkes. However, the excess rkk appears to
decrease over time alter COC dßcontinuatton and by 10 yeas utter cessation the increased
ri* disappears. Some studies report an inaeased ri* wth duration of use while otha stud
ies do not and no consistent reiattonshps have beo: found with dose a type of steroid. Some
studies have found a small increase ri rkk tawomen who fist use COCs betae age 20. Most
studies show a simitar partem and ri* wih COC use regudless and a womans reproductive
history a ha family breasi cancer history. In addition, breast cancers diagnosed in current a
eua oral contraceptive usas may be less driicaly advanced than ri neva-users. Women who
carentry have a have had breast cancer should not use hormonal contraceptives because
breast canca k usualy a hamonally sensitive tuma. Some studies suggest that combriation
oral contraceptke use has been associated with an inaease h the rkk of cervical intraep
ithelial neoplasia ri some populations and women. However, there continues to be cxntroversy
about the extent to which such fhdhgs may be due to dlterences n sexual behautor and othu
factors, h spte ot many studies of the rehtionshp between aal contraceptive use and breast
and conical cancers, a cause-and-ettedrehtionshp has not been established, it is not known
whether ORTHO BRA® is distinct from aal contraceptkes with regard to the above state
ments. 4 Hepatic Neoplasia: Benign hepatic adenomas are associated with homtonal con
fraceptke use, alhough the riddance ot benign tumors is rare in the United States. Indired
calculations have estimated the attributable rt* to be in the range ot 32 casesrf 00,000 to
users, a ri* friat Increases after tour a mae years and use, especially with hormonal caitra
ceffrwes contanhg 50 mtarograms a mae and estrogen. Rupture of benign, hepatic adenomas
may cause death thriugh ritra-abdomhal hemorrhage. Studies from Britain and the US have
show an ricreased rtak and developing hepatocellular cucrioma h tong term (a 8 years) oral
contraceptke users. Howevu, these cancers ue extremely rare in the U.S. and the attrbuta
hte rkk (the excess incidence) of kvu cancus in oral contraceptive users approaches less than
one per million users. I is unknown whether ORTHO EVRA® is distrid from oral contraceptives
ri tree regent. 8 Ocular Leatonu Thue have been dnical case reports and retinal thrombosis
associated wtfri the use ot hamonal contraceptkes. ORTHO BRA® should be discontinued if
thus is unexplained partial a complete toss ot vision; onset of proptosis a diplopia;
papilledema; a retinal vascular lestons. Appropriate diagnostic and therapeutic measures
should be undotakoi immediately 8 Hormonal Contraceptive Use Betae Or During Early
Pregnancy: Extensive epidemiological studies have revealed no inaeased rtak ot birth defects
ri women who have used oral contraceptives prtor to pregnancy. Studies also do not indicate
a teratogenic efted. particularly ri so tar as cardiac anomalies and tmb reduction defects are
concerned, when aal contraceptives ue taken inadvertently during early pregnancy Combination
hormonal contraceptives such as ORTHO EVRA® should not be used to nduce withdraws l Weed
ing asateetfa pregnancy. ORTHO EVRA® should not be used durhg pregnancy to treat threat
enedahabitual abortion. It is recommended thatfor any patient who has missed two consecutive
periods, pregnancy mould be rated out. It the patient has not adhered to the presabed sched
ule fa the use ot ORTHO BRA® the possibilty ot pregnancy should be considered at the time
of the test missed period. Hormoial contraceptke use should be discontinued it pregnancy is
confirmed. 7. Gelbtadder Disuse: Earlier studies have reported an inaeased lifetime rela
tive rkk ot gafrbladda surgery ri usas a hormonal contraceptives and estrogens. Mae re
cent studies, howeva, have shown that tie relative rtak of developing galbladder disease among
hormonal contraceptke users may be mriimal. The recent findings a mriimal ri* may be re
lated to the use of hormonal contraceptive formulations contariing lower hamonal doses of
estrogens and progestris. Combriation hamonal contraceptives such as ORTHO BRA® may
wasen existing gaUbhdda disease and may accelerate the development of this disease ri
previously asymptomatic women. Women with a history of combination hamonal
confracefltae-retated cholestasis are mae Ikely to have the coxtlion recur with subsequent
combriation hormonal contraceptive use. 8 Carbohydrate And Upld Metabolic Effects:
Hamonal contraceptives have been shown to cause a deaease ri glucose tolerance in some
usus. Howevu, ri the non-diabetic woman, combkiaticn hamonal contraceptkes appear to
have no effect on tasting blood glucose. Prediabetic and diabetic women ri particular should
becuefuly monitored while tekhgcombhatkn hamonal confraceptives such as ORTHO EfflA*.
h dhical trials with oral contraceptives coiterimg ethinyl estradiol and nagestimate thue
were no driically significant changes in fasting blood gtacose levels. There were no clinically
significant changes ri glucose levels ova 24 cydes of use. Maeova, glucose toterance tests
showed no driically significant changes from baseline to cydes 3,12 and 24. In a 6-cycle
cknical trial wfrh ORTHO BRA® ttwre were no clriicaik sijiiticant changes in tasting blood
glucose from baselne to end ot treatment. A small proportion ol women will have persistent
liypertriglycaideniia while taking hamonal contraceptives. As decussed earlier (see WARN
INGS 1a and 1d). changes ri serum triglycerides and lipoprotein levels have been reported ri
hormonal contraceptka users: 8 Elevated Blood Preaaur* Women with significant hyper
tension should not be started on hormonal contraception. Women with a histay of hyperten
sion a hypertension-related diseases, a renal disease should be encouraged to use another
method ot contraception. I women eled to use ORTHO EVRA® .they should be moiitaed closeiy
and it a driically significant elevation of blood pressure occurs, ORTHO EVRA® should be
discontinued. Fa most women, elevated blood pressure wil return to namal alter stopping
hamonalcattraceptiws, and ttwre is no difference ri the occurrence ot hypertenskn between
tarn* and never users. An haaase h blood pressure has been reported it women tekng
hormonal contraceptives and this inaease k mae likely ri older hamonal contraceptive users
and with extended duration of use. Data from the Royal Cdtege ot General Praditioners and
subsequent randomized tftek have shown that the incidence ol hypertension increases with
ncreasing progestational activity. 10. Headache: The onset a exacerbation ot migraine
headache a the development of headache with anew pattern that is recurrent, persistent or
seme requres discontriuation of ORTHO EVRA® and evaluation of the cause. 11. Bleeding
kTagutarttter Breakthrough bleeding and spottrig ue sometimes encountered ri women using
ORTHO EVRA®. Non-hormonal causes should be considered and adequate diagnostic meas
ures taken to rule out malignancy, other pathology, or pregnancy in the event ot breakthrough
bleeding, as ri the case ot any abnormal vaginal bleeding. It pathology has been excluded, time
a a change to anolha contracepAke product may resolve the bleeding, h the event o! amen
orrhea, pregnancy should be rated out betae Meting use ot ORTHO EVRA®. Some women
may encounter amenorrhea or oligomenorrhea after discontriuation ot hamonal contracep
tive use, especialy vfrren such a condition was pre-existent. Bleeding Patterns: ri the cknical
trials most women started their withdrawal bleeding on frte fourth day ot the drag-tree
interval, and the median duration of withdrawal bleeding was 5 to 6 days. On avaage 26% ol
women pa cycle had 7 a mae total days ot bleeding and lot spotting (this ndudes both with
drawal flow and breakthrough bleeding and lot spottrig). 12. Ectopic Pregnancy: Ectopic as
well as Intrauterine pregnancy may occur ri contracepAke failures.
PRECAUTIONS: Woman should hacountaiad that ORTHO EVRA® does not protect against
HIV ritacßon (AIDS) and otha esotuMly transmitted infections. 1. Body Weight etBB lbs.
(BO kg): Resuts of cknical triate suggest that ORTHO EVRA® may be less effective in women
wih body weflit *l9B ts. (90 kg) than in women with lowa body weights 2 Physical
Examination And Follow-Up: It is good medical practice ta women us ng ORTHO EVRA®, as
fa all women, to have annual medical evaluation and physical eiaminations. The physical
exam ratal howeva, may be deteiTed until alter initiation ol hormonal contraceptives it
requested by the woman and judged appropriate by the cknician. The physical eiemnaffon
should ridude special raterence to blood pressure, breasts, abdomen and pelvic agans,
nctodrig Cervical cytology, and relevant labaatory tests. In case ot undiagnosed, pusistent or
reaxrent abnormal vaginal bleedng, appropriate measures should be conducted to rale out
malignancy a othu pathology. Women with a strong family history ot breast canca a who
have breast nodules should be montaed with particular care. 3. Lipid Disorders: Womui
who we being treated fa hypalipidemias should be tolowad clcsely it they elect to use
ORTHO BRA*. Some progestins may elevate LDL levels and may rendu the control ot hypa
lipidemias more difficult 4 Uver Function: jaundice develops in any woman using
ORTHO EVRA®, (he medication should be disconthued. The humones ri ORTHO EVRA® may
be poaly metabolized ri patents with impaired Uver function. 5. Fluid Retention: Steroid hor
mones tike those ri ORTHO EVRA® may cause some degree ot fluid retention. ORTHO EVRA®
should he preaabed with caution, and only with careful monAorrig. in patients with conditions
which might be aggravated by fluid retention. 6. Emotional Disorders: Women who become
significantly depressed while using combination hamonal contraceptives such as
ORTHO EVRA* should stop the medication and use another method ot contraception in an at
tempt to determine wlietha the symptom k drug related. Women with a history of depression
should beceretully observed and ORTHO EVRA® discontinued it significant depression occurs
7. Contact Lenses: Contact lane wearers vrio develop visual changes a changes in lens toP
uanoo should be assessed byanothttiaknologkt 8 thug Interactions: ChanoasnCcritracectke
Effectiveness Associated with Co-Admnistration of Other Drugs: Contraceptive effectiveness
may be reduced when hormonal contraceptives are co*administered with some antibiotics,
“If we pay a little
now, we will save
a lot later. It would
be like paying your
credits off today. ”
MICHAEL TANNER, CATO INSTITUTE
the older generation,” said David
John, a research fellow at the
Heritage Foundation. “The prom
ises have to be kept.”
Critics of the plan say the solu
tions being proposed are not the
best options.
“It takes money out of a fund
that is headed for bankruptcy,” said
Barry Bosworth, an economist at
the Brookings Institution. “It is a
completely manageable problem.
This whole business of trying to
carve something out of something
is absurd.”
Most upper-income Americans
do not depend on Social Security
alone when retiring. It is lower
income Americans who depend on
the system the most.
But Bosworth said there is a
pending crisis that is more impor
tant than Social Security.
An aging population is a prob
lem, Bosworth said, and politicians
just don’t want to discuss the health
care costs associated with it.
Although Bush has said he
gained a political mandate after
the election, he will face an obsta
cle getting a Social Security plan
passed in the U.S. Senate next year,
where the Republicans have only a
five-member majority.
“Congress tends to focus on
issues that are immediate in crisis,
like anew bridge on 1-75,” John
said. “This is an issue that requires
them to think well ahead.”
Contact the State id National
Editor at stntdesk@unc.edu.
News
President’s nominations
could power Latino voice
BY AARON PRUITT
STAFF WRITER
The fastest-growing minority in
America will soon gain a greater
voice in the White House.
President Bush has nominat
ed two Hispanic Americans for
Cabinet positions in his second
term: Carlos Gutierrez as secre
tary of commerce and Alberto
Gonzales as attorney general.
The announcement of the
two nominations excited some
in the Hispanic community who
were elated to see Latinos in the
Cabinet.
“It is a good thing that a Latino
is that high up in the government,”
said Alma Ramirez, a social worker
for El Centro Latino, a nonprofit
organization based in Carrboro.
“They could do something to help
the community.”
Several Hispanic organizations
have endorsed the nominations,
including the Latino Coalition,
which stated in a press release
that Gonzales is the “perfect
choice for the next U.S. attorney
general.”
But some experts are unsure
whether Gutierrez and Gonzales
will represent the Hispanic
minority.
Congress restructures visa limits
BY BROOKE M. GOTTLIEB
STAFF WRITER
The visa reform bill passed by
Congress this month will give
20,000 internationals with U.S.
graduate degrees a better chance
to obtain temporary jobs in the
United States.
Congress passed the L-l and H
antituegals, antconvutsarits, aid otha drags that naease metaboksm ot confraceptive statute
This could resul in unintended pregnancy ot breakthrough bieedhg. Examples ridude bubi
turates, griseolulvin, rifampin, phenybutazene, phenytoin. cactemazeprie, tetoemate, oxcu
bazeprie, topramate and possibly with ampidlri. Tire proposed mechanism and rituadion of
anttoiotics k different from that ot Iker enzyme-inducing drags. Literature suggests possible
nteractions with the concomitant use ot hormonal caitraceptives and ampdlin a tefracy
drie. In a pharmacokinetic *ug interaction study, oral admhkfration ol tetracydrie HCI,
500 ng q.id.tu 3 days prtor to and 7 days duringwear of ORTHO BRA® did not significantly
affect the pharmacokheiics of naelgestromh a fe Several of the anti-HIV protease hhtoitors
have been studied with co-admhisfration of oral combriation hormonal confraceptives;
significant changes (naease and deaease) in the mean AUC of the estrogen and progestn
have been noted ri some cases. The efficacy and safety of aal contraceptke protects may be
affected; it is unknown whetha this applies to ORTHO BRA®. Healhcare professionals should
retu to frte label ot the individual anti-HIV protease rihiMots lor further drag-drag interaction
kitormation. Habal products cortaririg St. John's Wort (Hypericum perforatum) may hduce
hepatic enzymes (cytochrome P 450) and p-glyceprotein transporta and may reduce the
efleetkeness and contraceptive steroids.Thk may also result in breakthrousfri bleeding. Inaease
in Plasma Hormone Levels Asaockted with Co-Admritstaed Drags: Co-admriistratton of
atorvastatin and certain oral contraceptives contaririg ethinyl estradiol naease AUC values
tor ethinyl estradiol by approxfrnafely 20%. Ascot* acid and acetaminoehai may Increase
plasma ethinyl estradiol levels, possbly by inhibition ot conjugation. CYP 3A4 inhibitors such
as traconazoteukatoconazote may naease plasma hormone levek. Chancres ri Plasma Levels
ol Co-Mirinistered Drugs: Combination hormonal caitraceptives contariing some synthetic
estrogens (e.g., ethinyl estradiol) may inhibit the metabolism 0 othu compounds, hasased
plasma concentrations of cyctospiorine, prednisolone, and ttreophyllhe have been reported wih
concomitant admrikfratton of oral contraceptives, ri addition, oral contraceptkes may nduce
the conjugation ot ottrer compounds Decreased plasma concentrations ot acetaminophen and
hasased clearance of temazepam, salicylic add, morphine end doftric add have been noted
when these drugs wae administered wth oral contraceptives. Aithocfli naelgestromri and
its metabolites inhtoit a variety of P 450 enzymes ri human kvu mtorosomee. the cknical
consequence ol such an hteradion on the levek ol ofrwr concomitant medications is Ikely to
be insignificant. Undu the recom mended dreingregimen, the In vivo concentrations of naelge
sfromri aid Its metaboites, even at the pe* serum levels, are relatively tow compered to the
inhbltoiy constant 00) based on resuls ot In who studies). Health care professionak ue
advised to also retu to prescribing infumation of co-admhistaed dugs ta recommendations
regardrig management of concomitant ttrerapy. 8 Interactions With Laboratory Taitc Cola h
endocrine and livu function tests and blood components may be affected by hamonal
contraceptives; a. Inaeased prothrombin and factors VII, VII, IX, and X; deaoasad antlthrom
bri 3; inaeased naephephrkre-induced platelet aggregability. b. Inaeased thyroid binding
gtobukn (TBG) leading to inaeased creutating total thyroid hamate, as measured by proteri
bound iodine (PBfr, T 4 by column a by radioimmunoassay. Free T3 resin uptake k deaeased,
reflecting the elevated TBG, free T 4 concentration is unaltered, c. Ottrer bindkig proteins may
be elevated in serum, and. Sex hormone binding globulins are haeased and result in elevated
levels ot total creutating endogenous sex steroids and corticoids; howeva, free a biologically
aetke levek eitha deaease ot remain unchmged. a. Triglycuides may be riaeesed aid
levek ot various ottrer Ipds and lipoproteris may be affected, t. Glucose toterance may be
deaeased. g. Seram folate levels may be depressed by hamonal contraceptke therapy. This
may be of cknical sigiificance if a woman becomes pregnant shortly alter discontinuing
ORTHO EVRA®. 18 Carcinogenesis: No carcinogenicity studies wae conducted wfrh rarelge
sfromri. Howeva, bridgrig PK studies were conducted usrig doses a NGM/EE which wae
used previously ri the 2-year rat carcinogenicity study and 10-year monkey toxicity study to
support the approval ot ORTHO-CYCLEN and ORTHO TRI-CYCLBI inter NDAs 19-653 Old
19-697, respectively. The PK studies demonstrated that rats and maikeys wae exposed to 16
and 8 times the human exposure, respectively, wth the proposed ORTHO EVRA® fransdumal
contraceptive system. Naelgesfromriwastestedin in-vitro mutagenicity assays bacterialptate
incorporation mutation assay, CHO/HGPRT mutation assay, chromosomal aberration assay
usrig cultured human puflieral Vmphocytes) and h one in-vivo test (rat mtoronudeu6 assay)
and found to haw no genotoxtopotenhal. See WARNNGS Section. 11. Pregnancy: (Yegnancy
CategoyX See CONTRAINDICATIONS andWARNNGS Sections. NaUgestromin was tested to
its reproductive toxicity in a rabbit developmental toxicity study by the SC route ol administra
tion. Doses and 0,1,2,4 and 6 mgfkg body weight which gaw systemic exposure a approxi
mately 25 to 125 times the human exposure wfrh ORTHO EVRA®, were administered daly on
gestation days 7-19. Maltormations reported were pew hyperttexicin at 4 and 6 mg/kg and
paw hyperextension and cleft palate at 6 mg/kg. 12. Nunlng Msßiars: The effects ol
ORTHO BRA® in raising mottias have nek been evaluated and are unknown. Small amounts
of combriation hamonal contraceptive steroids have been identified in the mill of nurehg
mothers and a tew adverse effects on the child have been reported, ridudhg jaundice and
breast enlargement, h addition, combriation hamonal oontraceptkes gken in the pcktpertum
period may interfae with lactation by decreashg the quantity and qualiy rt breast mile, long
term follow-up a infants whose mothers used combriation hormonal caitraceptives while breast
feeding has shown no deleterious effects. Howeva, the nursing mother should be
advised not to use ORTHO EVRA® but to use offer tarns a ccnfracepticn until she has com
pletely weaned ha chid. 13. PkdMrfc Uoa Safety and efficacy ot ORTHO EVRA® haw teen
established ri women ol reproductive age. Safety and efficacy are expected to be the same (a
post-pubertal adolescents unda the age al6 and ta users 16 years and okter. Use a this
product betae maerche is not indicated. 14 Geriatric Us* This product has not boon stud
ied in women ova 65 years ot age and is not indicated ri this population. 18 Sexually
Transrrfrtted Disease* Patients should be counseledthatthkproduct does notprotectagahst
HIV riiectton (ADS) and otha sexus hr transmitted diseases. 16. Patch Adhesion: Expaience
with mae than 70,000 ORTHO EVRA® patches wan lot cafrraception tor 6-13 cycles showed
that 4.7% of patches ware replaced because they eittrer let off (1.8%) a wae puffy detached
(2.9%). Similarly, ri a small study a patch wear undu conditions a physical exertion and vari
able temperature and humidity, less than 2% ot patches was replaced to complete or partial
detachment. It the ORTHO BRA* patch becomes partially or completely detached and
remark detached, insufficient tfrug delivery occurs. A patch should not be re-applied if I is no
kngu sticky, if it has become stuck to itsok a anothu surface, it it has othu material stuck
to I, aif it has become loose a (alien off before. Ia patch cannd be re-appked, anew patch
should be applied immediately. Supplemental adhesives or wraps shculd not be used to hold
(he ORTHO BRA® patch in place. It a patch is partially a completely detached tor mae than
one day |24 hours a mae) ORI the woman is not sure how tong the patch has been detached,
she may not be protected from pregnancy. She should stop the current contraceptive cycle and
start anew cycle immediately by applying anew patch. Back-up contraception, such as con
doms, spomicide, or diaphragm, mustbeusedfortlrefiret week of the new cycle.
INFORMATION FOR THE PATIENTS See Patient Package Insert
ADVERSE REACTIONS: The most common adverse events reported by 9 to 22% ol women
usng ORTHO EVRA* in clinical trials (N= 3,330) wae the fokowrig, ri order a deaeasng
ricktence: breast symptoms, headache, application site reaction, nausea, uppa respiratory
inteeffon, menstrual cramps, and abdominal pari.
The most frequent adverse events leading to discontinuation ri 1 to 2.4% a women usrig
ORTHO BRA* ri the trials included the following: nausea and/a vomiting, application site
reaction, breast symptoms, headache, and emotional iabikty.
Listed below are adverse events that have been associated with the use a combriation
hamonal contraceptives. These ae also likely to appty to combiralion transdermal hamonal
contraceptives such as ORTHO EVRA*.
An inaeased rt* of the tokowng serious adverse reactions has been associated wfrh the use
ol combriation hamonal contraceptives (see WARNINGS Section): 1. Thrombophlebtk and
venous thrombosis with or without embolism 2. Arterial thromboembolism 3. Pulmonuy
embolism 4. Myocardial rituction 5. Caebral hemorrhage 6. Cerebralthromboek 7. Hypertension
8. Gallbladder disease 9. Hepatic adenomas or benign kva tumas
There is evidence ol an associatian between the fokowrig oaidtlone and the use of combria
tion hamonal contracefAkes: 1. Mesenteric thrombosk 2. Retrial thrombosk
The follcwrig adwrse reactions have been reported n users of combriation hamonal con
traceptives and ae believed to be drag-related: I.Nausea2.Ybmitlng3. Gastrointestinal symp
toms (such as Uxtomria! cramps andbtoatng) 4. Breakthrough bleeding 5. Spotting 6. Change
h menstrual flow 7. Amenorrhea 8, Temporary iiterffkty after dkoonttnuation of treatment 9. Edema
10. Melasma which may pasist 11. Breast changes: tenderness, enlargement, seaetion
12. Change in weight (inaease or deaease) 13. Change ri cervical aoslon and seaetion
14. Diminution in lactation when given immediately postpartum 15. Cholestatic jaundice
16. Migraine 17. Rash (allergic) 18. Mental depression 19 Reduced tolerance to carbehydrates
20. Vaginal candidiasis 21. Change ri comeal curvature (steepening) 22. intolerance to
contact lenses
The following adverse reactions have been reported in users of combination hamonal
contraceptives and a cause and effect association has been neitha contrmed na refuted:
1. Pre-menstrual syndrome 2. Cataracts 3. Changes in appetite 4. Cystitis-like syndrome
5. Headache 6. Nervousness 7. Dizziness 8. Hirsutism 9. Loss ol scalp hair 10. Erythema
muttitorme 11. Erythema nodosum 12. Hemonhagic eruption 13. Vaginitis 14. Paphyria
15. Impared renal function 16. Hemolytic uremic syndrome 17. Acne 18. Changes ri Ibtdo
19 Colitis 20. Budd-Chiarl Syndrome
OVERDOSAGE: Saious ill effects have not been reported fokowrig accidental ngestion of targe
doses a hamonal caitraceptives. Ovadosage may cause nausea andyomitrig. and withdrawal
bieedhg may occur in females. Given the nature and design o! the ORTHO EVRA® patch, it is
unlikely that overdosage will occir Saious 111 effects have not been reputed fokowrig acute
rigestion ol targe doses of aal caitraceptives by young children, ri case of suspected ovadose,
all ORTHO BRA® patches should t removed and symptomatic treatment given.
ORTHg^cNEIL
ORTHO-McNEIL PHARMACEUTICAL, INC.
Raritan, New Jersey 08869
© OMP 2001 Revised: May 2003 631-10-660-2 B
“It is a good thing that a Latino is that
high up in the government. They could
do something to help the community.”
ALMA RAMIREZ, el centro latino
“Just because someone has a
Hispanic name doesn’t mean repre
sentation,” said Karen Kaufmann, a
professor of government and poli
tics at the University of Maryland-
College Park.
“The notion of a singular
Hispanic community is untrue.
Mexican Americans make up one
half of the Hispanic population in
America, and they do not really
relate with Cuban Americans,
Venezuelans or Puerto Ricans.”
Kaufmann also said the appoint
ments will have little effect on the
Hispanic vote, which traditionally
goes to Democrats but in which
Bush made inroads Nov. 2.
“If it was as easy as appointing
high-level positions, then African
Americans would have voted for
Bush, who appointed Condoleezza
Rice and Colin Powell, and that
didn’t happen.
“The kinds of issues Latinos care
about are the kinds of issues every
IB Visa Reform Act on Nov. 20 for
the 2005 fiscal year in an effort to
admit educated foreign workers
into the country.
An Lrl, or intracompany trans
feree, works for a company that has
locations in the United States and
in another country. For example,
an American company would be
aUp Batlg 3ar Utel
American cares about —a strong
economy, health care, education for
their children —and Democrats
are perceived as better on those
bread-and-butter issues.”
Kaufmann added that the nomi
nations of Gutierrez and Gonzales
were not about gaining votes or
tokenism.
There are simply more qualified
Hispanics to fill top-level positions,
she said.
Experts say the nominations of
Gutierrez and Gonzales are a step
in the right direction for Hispanic
representation.
“As the cycle continues, with
more Hispanics going through
the education system, there will
be more qualified Latinos to fill
prominent positions,” said Tina
Siragusa, executive director of El
Centro Latino.
Contact the State & National
Editor at stntdesk@unc.edu.
able to recruit an executive from
an overseas branch with an L-l visa
for three years.
According to the U.S. Citizenship
and Immigration Services Web
site, “The 11-lB is a nonimmigrant
classification used by an alien who
will be employed temporarily in a
specialty occupation or as a fashion
model of distinguished merit and
ability.”
In other words, a U.S. company
that seeks a specialist from over
seas can hire someone for she years
as an H-18. The legislation would
maintain the yearly cap for H-lB
visa holders at 65,000.
But the first 20,000 applicants
with a master’s or doctoral degree
will not be included in the cap,
allowing more people to obtain a
visa.
In addition, the bill will no lon
ger allow L-l workers to be subcon
tracted to third-party employers.
They also will be required to work
for their petitioning employer for
at least one year, instead of the six
months previously required.
Gerry Chapman, an immigra
tion and nationality lawyer from
Chapman Law Firm in Greensboro,
said that the improving economy
allows employers to hire more
workers, but that the H-lB cap
already has been reached.
But he said that if there are not
enough qualified employees in the
United States, a company should
be able to hire specialists from
overseas.
“With my own experience, every
single H-lB or L-l who has come
into the U.S. has had the effect of
creating jobs for other U.S. work
ers,” he said.
The bill is a trade-off between
supporters and opponents of
increasing the number of H-lB
visas issued to foreign workers.
“(Opponents of the bill) are
missing the big picture,” he said.
“They are seeing it as a zero-sum
game, but (the visa holders’) pres
ence in our economy has an expo
nentially beneficial effect.”
But the Institute of Electrical
and Electronics Engineers-USA
opposes the bill.
“We’re against the fact that
(Congress) granted the additional
20,000 exemptions,” said Chris
McManes, senior public relations
coordinator for the organization’s
U.S. branch.
“With an abundance of American
workers looking for employment,
we don’t think that additional for
eign workers (are needed).”
A report released by the IEEE
USA on Nov. 19 states that unem
ployment in the United States
dropped between the first and third
quarters this year after the Hl-B
cap was lowered from 195,000 for
the 2004 fiscal year.
“You have to look at the people
who lost their jobs,” McManes said.
“(In addition), when you increase
the number of workers in any field,
you can suppress wages.”
He also said the institute is con
cerned with the unfair treatment of
foreign workers.
He said it does not want tempo
rary foreign workers to be abused
with insufficient salaries or the
threat of losing their visas.
“We’re not against foreign work
ers; we’re not anti-immigrant,” he
said. “We just feel that if U.S. com
panies want to bring in workers
from overseas, they should be given
a better opportunity to become U.S.
citizens.”
Contact the State id National
Editor at stntdesk@unc.edu.