Copyright by Radhika Anantharaman Nair 2005 - The University of ...

More documents

Recommendations

Info

$61~\~SN~JVÃ¡~~~ :fuÃOZ$

Physicians claim that advertising causes patients to come in the office with aplethora of information and physicians are in a passive role of answering questions anddispelling false notions. They believe that this could compromise patient care and alsotake time away from the active role physicians want to play in treating the patient. 171Another argument regarding DTCA has been that it might lead to patientsbelieving that physicians are so uninformed and intellectually malleable that they areeasily manipulated into prescribing drugs demanded by patients. 172 DTCA can lead toconfusion, unhealthy pressure on the “doctor-knows-best” patient-physician relationship,and increased demand for brand-name costly drugs. 173With these ongoing debates andthe role DTCA is playing in today’s healthcare, the FDA has tried to regulate itextensively.Regulatory Issues for DTCA: Earlier RegulationsThe 1914 Federal Trade Commission Act established a new oversight body topolice advertising claims. Section 12 of this act prohibits false advertisements that couldinduce the purchase of food, drugs and cosmetics. 174 This became the foundation for theregulation of advertising until the 1962 Kefauver-Harris Drug Amendments. In 1938,Congress passed the Food, Drug and Cosmetics (FD&C) Act that granted the FDAjurisdiction over labeling of all drugs both prescription and OTC medications. The 1962171172173174Holtz WE. Consumer-directed prescription drugs advertising: Effects on public health. Journal of Lawand Health. 1998-99;13(2):199-218.Angel JE. Drug advertisements and prescribing. Lancet. November 23 1996;348:1452-1453.Prescription drugs: Little is known about the effects of direct-to-consumer advertisements: UnitedStates General Accounting Office, Report to the Chairman, Subcommittee on Oversight andInvestigations, Committee on Energy and Commerce, House of Representatives; July 1991. GAOPEMD-91-19.Sachs EA. Health claims in the market place: The future of FDA and the FTC's regulatory split. Foodand Drug Law Journal. 1993;48:268-?44
Kefauver-Harris Drug Amendments also transferred jurisdiction for prescription drugadvertising to the FDA, but left the authority to regulate OTC advertising with theFTC. 175 According to Section 502(n), the FDA regulated the promotion of prescriptiondrugs to physician and consumers. 176According to the Kefauver-Harris Amendments to the FD&C Act, theadvertisements should have the following attributes:(a) Should not be false or misleading;(b) Must present a fair balance of information on benefits and risks;(c) Must contain facts regarding the advertised uses of the medication; and(d) Provide “brief summary” which should include every risk from the product’sapproved labeling. 177To regulate DTCA, the FDA chose to adapt the extensive requirements for labelingto advertising. Under section 502(a) of the FD&C Act, prescription drug labeling shouldprovide a brief summary and fair balance of benefits and risks. 178 Advertisements ofprescription drugs should provide a “brief summary” which includes the adverse eventsprofile of the drug, contraindications, warnings, precautions, effectiveness, andindications for use. This is called a “brief summary” because it does not have to containall of the dosage and pharmacological information that the drug’s labeling should have.175176177178Kessler DA, Pines WL. The federal regulation of drug advertising and promotion. Journal of theAmerican Medical Association. November 14, 1990;264(18):2409-2415.21 U.S.C. § 352(n) {FDCA § 502(n)}.Kefauver-Harris Act 21. Code of Regulations. Vol 2.2.1; 1962.Kessler DA, Pines WL. The federal regulation of drug advertising and promotion. Journal of theAmerican Medical Association. November 14, 1990;264(18):2409-2415.45
Page 1 and 2:
CopyrightbyRadhika Anantharaman Nai
Page 3 and 4:
EVALUATION OF FACTORS RELATED TO PR
Page 5 and 6:
AcknowledgementsThis dissertation a
Page 7 and 8:
estimate prices of the drugs. Time
Page 9 and 10:
PageRegulatory Changes in 1997 and
Page 11 and 12:
PageCHAPTER 4: METHODOLOGY . . . .
Page 13 and 14:
PagePrescription Drug Expenditures
Page 15 and 16:
PageObjective II . . . . . . . . .
Page 17 and 18:
PageDTCA Expenditures . . . . . . .
Page 19 and 20:
LIST OF TABLES PageTable 2.1: Regul
Page 21 and 22:
PageTable 5.20: Mixed Model Analyse
Page 23 and 24:
PageTable 5.37: Mixed Model Analyse
Page 25 and 26: PageTable 5.54: Mixed Model Analyse
Page 27 and 28: PageTable 6.5: Results for Hypothes
Page 29 and 30: PageFigure 5.4: Trends in Total DTC
Page 31 and 32: PageFigure 5.30: Trends in Total DT
Page 33 and 34: CHAPTER 1: INTRODUCTIONBACKGROUNDPr
Page 35 and 36: Figure 1.2: Annual Percent Change i
Page 37 and 38: addition, the guidelines for detect
Page 39 and 40: Direct-to-Consumer Advertising Expe
Page 41 and 42: of the guidelines, manufacturers fe
Page 43 and 44: percent whereas private health insu
Page 45 and 46: public coverage has remained about
Page 47 and 48: According to the National Center fo
Page 49 and 50: As mentioned previously, DTCA can a
Page 51 and 52: one drug prescribed has not increas
Page 53 and 54: drugs is encouraged. 66 All these f
Page 55 and 56: (a) To determine the relationships
Page 57 and 58: enefit of DTCA, many claim that DTC
Page 59 and 60: persistent and will shop around unt
Page 61 and 62: advertisements describe and discuss
Page 63 and 64: These advertisements were aired mai
Page 65 and 66: During this time, the FDA realized
Page 67 and 68: included media tours in which physi
Page 69 and 70: care for their condition, it does n
Page 71 and 72: It is possible that due to the infl
Page 73 and 74: mistakenly believe that there is a
Page 75: Thus, advertising could cause patie
Page 79 and 80: equire the industry to provide a de
Page 81 and 82: (d) Provide a statement that inform
Page 83 and 84: choose which side effects and contr
Page 85 and 86: The studies that tested these effec
Page 87 and 88: were more likely to have seen an ad
Page 89 and 90: disease it treats (51.0%). One-half
Page 91 and 92: advertised drug and on average used
Page 93 and 94: about a specific brand (1999-13.0%,
Page 95 and 96: Table 2.2: Prevention Magazine Surv
Page 97 and 98: eported that the physician recommen
Page 99 and 100: Maddox and Katsanis in a study publ
Page 101 and 102: drug, but not the disease or condit
Page 103 and 104: and 35.0 percent were prompted to h
Page 105 and 106: Glasgow et al. identified factors r
Page 107 and 108: Time, Inc. conducted two surveys of
Page 109 and 110: not be disappointed in the physicia
Page 111 and 112: quit smoking were not aware of it.
Page 113 and 114: 2001 study by Allison-Ottey et al.
Page 115 and 116: and perceived risk. Argument qualit
Page 117 and 118: esults were obtained from most stud
Page 119 and 120: In 1997, IMS Health along with Phys
Page 121 and 122: medication and 7.0 percent gave the
Page 123 and 124: Results of the studies described in
Page 125 and 126: The study reported that 46.0 percen
Page 127 and 128:
setting were more likely to have a
Page 129 and 130:
advertising to build brand loyalty
Page 131 and 132:
advertisements, headlines and subhe
Page 133 and 134:
offer to provide more information i
Page 135 and 136:
was increased, recall of risk infor
Page 137 and 138:
SummaryConsumers are increasingly a
Page 139 and 140:
including drugs used to treat high
Page 141 and 142:
the increased prescription drug exp
Page 143 and 144:
Office focus cluster had high expen
Page 145 and 146:
especially detailing. This made it
Page 147 and 148:
to a 47.8 percent increase in presc
Page 149 and 150:
enign prostatic hypertrophy. 311 Ev
Page 151 and 152:
which helped assess the impact of D
Page 153 and 154:
elationship was significant only af
Page 155 and 156:
DTCA expenditures and market share
Page 157 and 158:
classes accounted for 75.0 percent
Page 159 and 160:
DTCA expenditures along with prescr
Page 161 and 162:
eneficiaries with coverage may rece
Page 163 and 164:
utilization of prescription drugs i
Page 165 and 166:
who were uninsured or were enrolled
Page 167 and 168:
Access to Care and Utilization of P
Page 169 and 170:
Among Medicare beneficiaries, suppl
Page 171 and 172:
coverage filled fewer prescriptions
Page 173 and 174:
than men and are receive more presc
Page 175 and 176:
the prescription drug accounted for
Page 177 and 178:
vs. 17.9%) or heavy users (21.4% vs
Page 179 and 180:
visits than men. In 1998, the avera
Page 181 and 182:
each household was causally associa
Page 183 and 184:
eports, employment status, and read
Page 185 and 186:
Demographics (Age and Gender) and U
Page 187 and 188:
drugs use was largely due to drugs
Page 189 and 190:
The study results indicated that th
Page 191 and 192:
though the difference in the averag
Page 193 and 194:
According to the study based on dat
Page 195 and 196:
Summary of the LiteratureThese stud
Page 197 and 198:
In a model predicting prescription
Page 199 and 200:
Summary of the LiteratureUtilizatio
Page 201 and 202:
esults are skewed, especially when
Page 203 and 204:
Several other factors and market dy
Page 205 and 206:
H 1 : An increase in DTCA expenditu
Page 207 and 208:
H 14 : There is no significant rela
Page 209 and 210:
H 24 : An increase in the proportio
Page 211 and 212:
GastrointestinalsObjective ITo dete
Page 213 and 214:
Page 215 and 216:
access to care will be significantl
Page 217 and 218:
AntihypertensivesObjective ITo dete
Page 219 and 220:
Page 221 and 222:
Data Collection MethodologyThe basi
Page 223 and 224:
As mentioned earlier, CMR also coll
Page 225 and 226:
oadcasting industry survey conducte
Page 227 and 228:
stated previously, data for the rem
Page 229 and 230:
are to be recorded. A perforation b
Page 231 and 232:
truncated, but this leads to an und
Page 233 and 234:
As discussed in Chapter 2, with the
Page 235 and 236:
The total monthly advertising expen
Page 237 and 238:
64 years, 65-74 years, and 75 years
Page 239 and 240:
Table 4.2: United States City Avera
Page 241 and 242:
including chronic conditions (e.g.,
Page 243 and 244:
2000. The ICD-9 CM code for irritab
Page 245 and 246:
The ICD-9 CM codes used to identify
Page 247 and 248:
errors, the significance of the par
Page 249 and 250:
presence of autocorrelation, data w
Page 251 and 252:
measured for each drug over a perio
Page 253 and 254:
August 1997 and September 1997 to A
Page 255 and 256:
CHAPTER 5: RESULTSChapter 5 will pr
Page 257 and 258:
$39.8 million in 1995 accounting fo
Page 259 and 260:
each year to $1,091.7 million in 19
Page 261 and 262:
The number of months represent the
Page 263 and 264:
print and billboard advertising exp
Page 265 and 266:
1998, but then decreased every year
Page 267 and 268:
advertised allergy medications was
Page 269 and 270:
Figure 5.8: Trend in the Number of
Page 271 and 272:
Since 1997, nine out of ten individ
Page 273 and 274:
increase in prescription drug expen
Page 275 and 276:
The total DTCA expenditures for ant
Page 277 and 278:
Figure 5.14: Trend in DTCA Expendit
Page 279 and 280:
1994 to $14.3 million in 1995, but
Page 281 and 282:
Table 5.6: Number and Percentage of
Page 283 and 284:
Figure 5.17: Trends in Percentage o
Page 285 and 286:
Prescription Drug ExpendituresThis
Page 287 and 288:
Figure 5.20: Trends in Prescription
Page 289 and 290:
Since the guidelines for broadcast
Page 291 and 292:
Gastrointestinal-Related Physician
Page 293 and 294:
visits and number of prescriptions
Page 295 and 296:
prescriptions written decreasing to
Page 297 and 298:
64.0%), had health insurance covera
Page 299 and 300:
Figure 5.27: Trends in Total Prescr
Page 301 and 302:
AntidepressantsDTCA ExpendituresFig
Page 303 and 304:
The total DTCA expenditures increas
Page 305 and 306:
percentage of visits when the visit
Page 307 and 308:
Page 309 and 310:
presented in the methodology, the e
Page 311 and 312:
Figure 5.35: Trends in Prescription
Page 313 and 314:
heavily advertised antihypertensive
Page 315 and 316:
antihypertensives and number of hyp
Page 317 and 318:
Figure 5.38: Trend in the Number of
Page 319 and 320:
Page 321 and 322:
study, total drug expenditures did
Page 323 and 324:
the advertised drugs from the respe
Page 325 and 326:
In the dataset for mixed model anal
Page 327 and 328:
monthly allergy-related physician v
Page 329 and 330:
Table 5.14: Test Statistics for Ord
Page 331 and 332:
of individuals 45 years and older,
Page 333 and 334:
and time period indicates that the
Page 335 and 336:
values in the dataset for the perce
Page 337 and 338:
Increase in the allergy-related vis
Page 339 and 340:
Table 5.18: Mixed Model Analysis fo
Page 341 and 342:
elated visit increase, the drug exp
Page 343 and 344:
independent variables was associate
Page 345 and 346:
The Durbin-Watson statistic for thi
Page 347 and 348:
untransformed values yielded differ
Page 349 and 350:
Mixed Model Analysis with Transform
Page 351 and 352:
Table 5.25: Untransformed Mixed Mod
Page 353 and 354:
significant in both time periods (T
Page 355 and 356:
The significant variables in this a
Page 357 and 358:
Page 359 and 360:
in the drug expenditures for advert
Page 361 and 362:
coefficient for this variable was 6
Page 363 and 364:
years, 45-64 years, and 65 years an
Page 365 and 366:
in time period one compared to time
Page 367 and 368:
Page 369 and 370:
Table 5.34: Mixed Model Analysis fo
Page 371 and 372:
every one percent increase in indiv
Page 373 and 374:
less than 25 years, 25-44 years, 45
Page 375 and 376:
significant relationships in both t
Page 377 and 378:
visit {df=235, t=9.64, p
Page 379 and 380:
variables in the equation. For ever
Page 381 and 382:
for gastrointestinal-related visits
Page 383 and 384:
Page 385 and 386:
In the absence of the visit variabl
Page 387 and 388:
expenditures, and drug expenditures
Page 389 and 390:
Table 5.46: Mixed Model Analyses fo
Page 391 and 392:
untransformed variables were reconf
Page 393 and 394:
Page 395 and 396:
while controlling for other variabl
Page 397 and 398:
1997 to April 2001), which categori
Page 399 and 400:
antidepressants, the analysis was r
Page 401 and 402:
variables in the equation. The perc
Page 403 and 404:
The only age variable that was sign
Page 405 and 406:
prescriptions written for advertise
Page 407 and 408:
in time period two was not supporte
Page 409 and 410:
with health insurance coverage had
Page 411 and 412:
with the transformed variables (Tab
Page 413 and 414:
prescription for advertised antidep
Page 415 and 416:
significant variables indicating th
Page 417 and 418:
antidepressants and were 65 years a
Page 419 and 420:
Time series analysis was employed t
Page 421 and 422:
Page 423 and 424:
The results of the mixed model anal
Page 425 and 426:
The significant variables in the an
Page 427 and 428:
number of prescriptions written for
Page 429 and 430:
elated visits, DTCA expenditures fo
Page 431 and 432:
The interaction between DTCA expend
Page 433 and 434:
An increase in number of hypertensi
Page 435 and 436:
in the equation. In time period two
Page 437 and 438:
200 and 360 outlets (spot markets),
Page 439 and 440:
to three reasons for visits were re
Page 441 and 442:
The access or health insurance cove
Page 443 and 444:
• A wider use of the drugs may re
Page 445 and 446:
Table 6.1: Results of the Hypothese
Page 447 and 448:
Tables 6.3 and 6.4 provide a snapsh
Page 449 and 450:
market and advertising of these dru
Page 451 and 452:
(p=0.071). On splitting the dataset
Page 453 and 454:
antidepressants and depression-rela
Page 455 and 456:
The results for age should be inter
Page 457 and 458:
Objective II: Hypotheses for the De
Page 459 and 460:
Objective IV: Hypotheses for Depend
Page 461 and 462:
For every $1,000 increase in DTCA e
Page 463 and 464:
prescriptions written for antidepre
Page 465 and 466:
were positively and significantly r
Page 467 and 468:
coverage were more likely to be pre
Page 469 and 470:
antihypertensives reduced drastical
Page 471 and 472:
The upheavals in the market may be
Page 473 and 474:
a result of advertising, patients m
Page 475 and 476:
included in the study, inducing phy
Page 477 and 478:
new prescriptions or rather are a r
Page 479 and 480:
Objective III: Hypotheses for the D
Page 481 and 482:
Objective IV: Hypotheses for the De
Page 483 and 484:
DTCA ExpendituresSimilar to the rel
Page 485 and 486:
expenditures and prescriptions writ
Page 487 and 488:
expenditures for antihypertensives.
Page 489 and 490:
also possible that individuals rece
Page 491 and 492:
eported increased expenditures by a
Page 493 and 494:
awareness for consumers and physici
Page 495 and 496:
as well as number of prescriptions
Page 497 and 498:
Some studies have reported that wom
Page 499 and 500:
Physician VisitsPhysician visits (s
Page 501 and 502:
individuals had a positive relation
Page 503 and 504:
not only due to DTCA, but also othe
Page 505 and 506:
should be repeated for these newer
Page 507 and 508:
GLOSSARY OF ACRONYMSAARP - American
Page 509 and 510:
Average Wholesale Price of Drugs, 1
Page 511 and 512:
Total DTCA Expenditures (in million
Page 513 and 514:
Number and Percentage of Prescripti
Page 515 and 516:
Page 517 and 518:
Percentage of Women Among those who
Page 519 and 520:
Appendix FTables for Percentage of
Page 521 and 522:
Percentage of Individuals with Heal
Page 523 and 524:
Number And Percentage Of Prescripti
Page 525 and 526:
Page 527 and 528:
DrugCapoten®ToprolXL®Altace®Numb
Page 529 and 530:
Appendix HFigures for Percentage of
Page 531 and 532:
Percentage of Prescriptions Written
Page 533 and 534:
Appendix ITables for Total Prescrip
Page 535 and 536:
Total Prescription Drug Expenditure
Page 537 and 538:
BIBLIOGRAPHY. 21 C.F.R. § 202.1(1)
Page 539 and 540:
Direct-to-consumer advertisement of
Page 541 and 542:
Health care in America: Trends in u
Page 543 and 544:
Report to the President: Prescripti
Page 545 and 546:
Angel JE. Drug advertisements and p
Page 547 and 548:
Cain G. A remedy for rising drug co
Page 549 and 550:
Eng HJ, Lairson DR. Prescribed medi
Page 551 and 552:
Goldman DP, Joyce GF, Escarce JJ, e
Page 553 and 554:
IMS-Health. Paper presented at: Pha
Page 555 and 556:
Lipsky MS, Taylor CA. The opinions
Page 557 and 558:
Morris LA, Mazis MB, Brinberg D. Ri
Page 559 and 560:
Rosenbach ML, Irvin C, Coulam RF. A
Page 561 and 562:
Smart S, Williams C. Half of drug a
Page 563 and 564:
Wind Y. Pharmaceutical advertising:
show all

Copyright by Radhika Anantharaman Nair 2005 - The University of ...

Create successful ePaper yourself

Delete template?

Save as template?