Index [assets.cambridge.org]assets.cambridge.org/97805218/54962/index/9780521854962_index.pdf · Index AAP (American Academy of Pediatrics), 48, 57 Abbott Laboratories Fund, 277 abortion
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Index
AAP (American Academy of Pediatrics),48, 57
Abbott Laboratories Fund, 277abortion policies
stem cell research and, 20Abrams, Thomas, 129, 130absorption, distribution, metabolism and
elimination studies. See ADMEAcademy of Managed Care Pharmacy.
See AMCPacetysalicylic acid, 151. See also aspirinAcquired Immune Deficiency Syndrome.
See HIV/AIDSAct-Up New York, 306ADAP (AIDS Drug Assistance
Program), 310, 311Additional Safeguards for Children in
metabolism and elimination), 48, 56genetics and, 83
Administrative Procedure Act. SeeAPA
adverse event reporting system. SeeAERS
advertising, 3DTCA, 127reminder, 156–157
AERS (adverse event reporting system),55
FDA and, 54Africa
AZT in, 273–274HIV/AIDS in, 28, 273, 339, 347–348
Africa, sub-SaharanHIV/AIDS in, 273, 452IP rights in, 346
African Americansantidepressants and, 80clinical testing and, 93health literacy for, 88high blood pressure among, 84pain medications for, 80race-based drug therapies for,
94smoking and, 86Tuskegee syphilis study and, 19,
101Africans
alternative treatments for, 90AIDS activism (medical), 15, 301–308
Act-Up New York, 306ATAC, 307, 316collaboration in, 308–311community involvement for, 308conflicts of interest and, 316–318ETAG, 307in EU, 307FDA approval and, 308, 312–314FPC and, 311NIH and, 308pharmaceutical industry funding for,
Clean Air Act (US), 114Clemente, CL, 264clinical equipoise, 62–63, 74Clinical Investigation of Medicinal
Products in the Pediatric Population,58, 59
clinical research. See research, clinicalclinical studies. See trials, clinicalclinical trials. See trials, clinicalClinton, Bill, 340, 347cloning, 114–116
in France, legal limits, 119Human Cloning Prohibition Act, 113reproductive, 111SCNT, 110, 111in South Korea, legal limits, 120US government restrictions on, 118
Code of Federal Regulations. See CFRCollaborating Centers for Influenza,
under ethical templates, 221–222in individualized therapies, 94“off-label” use for, 69, 132pediatric calculations for, 48in pediatric research, 52–53
double-blind trials, 24scientific ethics and, 23
Drews, Jurgen, 10, 11drug dosing. See dosing, drugsDrug Enforcement Agency. See DEAdrug labeling. See labeling, drugsdrug licensing. See licensing, drugsdrug pricing. See pricing, drugsdrug recalls. See recalls, drugdrug research. See research, clinicaldrug safety. See safety, drugsdrug sales. See sales, drugdrugs, antiviral
for influenza, 354drugs, “blockbuster,” 29, 328–329drugs, fixed-dose combination
clinical trials for, 38as treatment option, 38
drugs, “lifestyle,” 127, 253. See also drugs,prescription
drugs, new, 186, 235in Australia, cost guidelines for, 237“blockbuster,” 29, 328–329clinical trials for, 38cost-effectiveness of, 231–236development costs for, 27, 252, 311–312government reimbursement for (in
US), 288–289for HIV/AIDS, 253misbranding, 185–186older v., 142–143in UK, cost guidelines for, 238in UK, launches for, 25in US, 25
drugs, prescription, 136–145disadvantages of, 143DTCA and, sales from, 173FDA and, 155fixed-dose combination of, 38for hypertension, 139“lifestyle,” 127marketing for, 153–154, 170MUSE, 163OxyContin, 162–163“Patient Package Inserts” for, 155pharmaceutical industry and, 3Prograf, 164risk-benefit ratios for, 137sales figures for (2003), 153, 174Viagra, 213, 217–219
“adequate provision” as part of, 157Competitive Media Reporting and, 177consumer involvement in, 171–172Consumer-Directed Broadcast
Advertisements and, 157educational value of, 178–179in EU, 202expenditures for, 17, 127Fairness Doctrine and, 182FDA and, 128, 129, 170financing arrangements for,
adjustments, 182–183general medication use and, influence
on, 144, 175–176government policy alternatives to,
180–183
for “lifestyle” drugs, 127literature on, 179long-term influence of, 172–173, 181National Ambulatory Medical Care
Survey and, 177objectives of, 128, 153–154, 170patient information and, 202patient treatment and, influence on,
169, 176–177, 182patient-physician relations and,
influence on, 170physician detailing and, 128physicians’ visits and, influence on, 175prescription drug sales and, 173print advertisements for, 156public health care and, 128–131,
169–170, 179reminder ads and, 156–157Rogaine and, 171surveys for, 153, 172, 173–175, 177television and, 156treatment therapies and, influence on,
170, 177–178types of, 156
Dunn, Belynda, 206Dworkin, Ronald, 279
The Economist, 235“Effects of a Single Dose of
Dextroamphetamine in AttentionDeficit Hyperactivity Disorder: AFunctional Magnetic ResonanceStudy,” 61
EG (embryonic germ) cells, 121. See alsostem cells
antidepressant research by, 77Guidelines for Good Clinical Practice for
Trials on Pharmaceutical Products.See GCP
Guillain Barre syndrome, 468
HaitiHIV/AIDS in, 278–279
Hale, G. Victoria, 11Hardin, Garrett, 267, 269Harris polls, 3Hay, Joel, 133, 134Hayes, Arthur Hull, 155health care systems. See also health care
systems, private; health care systems,public
access to, 227chronic care as part of, 376consumer involvement in, 171–172cost-benefit analysis for, 228, 230–231cost-effectiveness for, 228as delivery government role in, 283demand management for, 201–202DTCA and, 128–131, 169–170, 179elderly care as part of, 376expenditures for (US), 134, 225during globalization, 291–292government role in, 283information technologies for, 172, 294limit setting within, 206–207literature for (US), 232–234in The Netherlands, 200nontoxic treatments as part of, 294outpatient care within, 294–295patient’s rights under, 171per capita spending, pharmaceuticals
(international), 226pharmacy benefit management in,
and, 35in Botswana, 277clinical research participation and, for
patients, 19clinical testing for, 93combination therapies for, 305, 348,
462“compassionate use” programs for, 25corporate collaborations and, 33–36didanosine for, 303, 304disease markers for, 304drug pricing for, 302“expanded access” programs for, 25Forum for Collaborative HIV
Research, 298in Haiti, 278–279as international pandemic, 281, 452IP rights and, 268mother-to-child transmission, 222, 461new drug development for, 253patents system and, 253patient’s rights and, 104–105possible treatments for, 302poverty and, 338–339property rights and, 379–381protease inhibitors and, 305Rescue Principle for, 381–385in South Africa, 339in sub-Saharan Africa, 273, 452in Tanzania, 277–278, 279Triomune, 349US government funding for, 341–342vaccine development for, 274women and, 372
informed consent, 44–45, 197–199age for, 103for children, 43–44in China, 44in clinical trials, 39cultural belief systems and, 103under Helsinki Declaration of Ethical
Principles for Medical ResearchInvolving Human Subjects, 197
husband-wife relationships and, 44in International Ethical Guidelines for
Biomedical Research InvolvingHuman Subjects, 44
in non-therapeutic clinical research,42–43
The Nuremberg Code of 1947 and, 44under state-controlled systems, 197in UK, 197
“Informed Patient” Project, 130, 196, 198,204–205
innovations. See also drugs, new; patentsin France, 333–334in Germany, 333incentives for, 243–244, 288“off-label” uses and, 290under Orphan Drug Act, 289recognition for, 287–290in UK, 333in US, 333
Institute for OneWorld Health, 11, 381,400, 401
Institute of Medicine, 16institutional ethics committee. See IECInstitutional Review Boards. See IRBsinsurance
formularies and, 147intellectual property. See IPIntellectual Property Institute. See IIPIInternational AIDS Vaccine Initiative.
See IAVIInternational Committee of Medical
Journal Editors, 78International Conference on
Harmonisation of TechnicalRequirements for Registration ofPharmaceuticals for Human Use. SeeICH
International Ethical Guidelines forBiomedical Research InvolvingHuman Subjects, 37, 41, 42
informed consent as part of, 44
International Society forPharmacoeconomics and OutcomesResearch, 237
Internetdrug sales and, 293medical information and, 198
InvermectinMerck Industries and, 12
Investing in Health, 345IOM (Institute of Medicine), 69, 355, 356,
421“minimal risks” and,
recommendations, 71IP (intellectual property)
alliance models for, 275–280in Brazil, 268challenges to, 260, 265–268corporate investments and, 265development of, 260HIV/AIDS and, 268human rights and, 261–280in India, 265–266, 268industries, pharmaceutical, and, 3Jefferson, Thomas, and, 262Locke, John, and, 262, 263moral imagination and, 275–276multiple perspectives system for,
antiretrovirals in, 347Kessler, David, 15Kipling, Rudyard, 295Kordel v. United States, 186
drug labeling and, 187Koski, Greg, 368, 381Kremer, Michael, 244
labeling, drugs“black box,” 13under FDCA, 186–187intended uses and, 438interaction warnings for, 91in Kordel v. United States, 187pediatric rules for, 50regulations for, 49, 438
Laetrile, 15The Lancet, 16language
clinical trials and, as barrier, 19health literacy and, 87informed consent and, as factor for,
103LDC (least-developed countries),
273. See also “third world” nationsdrug distribution in, 279
least-developed countries. See LDCLee, S, 82Leeper, Mary Ann, 277licensing, drugs
clinical research and, 22compulsory, 338, 460–461in South Africa, 339
life expectancy ratesinternational increase in, 236
“lifestyle” drug(s), 127, 253. See alsodrugs, prescription
oaths, medical, 107–108. See also ethics;Hippocratic Oath
Hippocratic, 22, 107, 131Maimonides and, 107
Office of Pediatric Therapeutics, 69Office of Technology Assessment. See
OTA“off-label” uses (prescription drugs)
dosing for, 69, 132under FCA, 191FDA approval for, 187, 193under FDCA, 185, 187under First Amendment, 188–191, 193in Franklin v. Parke-Davis, 191future applications for, 193–195innovations and, 290
old age dependency ratios, 242onchoceriasis. See River BlindnessOrphan Drug Act, 30, 289OTA (Office of Technology Assessment),
114, 123OTCs (over-the-counter medications).
See also medications, generalaspirin, 150–152Claritin, 141drug modifications and, 142FDA specifications for, 141–142Motrin, 141Prilosec, 141third party payer system and, 134, 141Zantac, 141
Ottesen, Eric, 389outpatient care, 294–295over-the-counter medicines. See OTCsOxfam, 259OxyContin, 162–163
indicated use violations for, 163usage risks for, 163
PAC (Pediatric Advisory Committee),69
PAPs (Patient Assistance Programs)in public health care systems, 292, 293
Parke-DavisFranklin v. Parke-Davis and, 191–193Neurontin and, 132, 133, 191“off-label” drug uses and, 132
Parkinson’s Disease, 15paroxetine, 76“The Participation of Underrepresented
HIV/AIDS and, 253for Jefferson, Thomas, 261legal protections for, 140, 262, 337–339market competition and, 242within pharmaceutical industries, 10protection for (US), 227, 350in public domain, 244–246reward systems for, 245social benefits from, 448–449in “third world” nations, 258WHO and, 244
Patient Assistance Programs. See PAPs“Patient Package Inserts,” 155patient selection
EU Directive on Clinical Trials and, 70GCP and, 70under Helsinki Declaration of Ethical
Principles for Medical ResearchInvolving Human Subjects, 70
for pediatric research, 70–71patient’s rights. See rights, patient’sPaxil, 54, 65
adverse reactions to, 55efficacy trials for, 55
PC (Pediatric Committee), 70EMEA and, 70
Pearson v. Shalala, 190Pediatric Advisory Committee. See PACPediatric Committee. See PCpediatric research. See research, pediatricPediatric Research Equity Act. See
PREAPediatric Rule, 50pediatrics. See also research, pediatric
AAP and, 48labeling rules, 50“off-label” medication use in, 69
Penicillin, 27Pfizer Pharmaceuticals, 358
IP rights for, 268pharmaceutical industries. See industries,
pharmaceuticalPharmaceutical Manufacturers
Association of America, 133pharmaceutical research. See research,
pharmacovigilanceBPCA on, 54in pediatric research, 54–56
pharmacy benefit managementaccountability under, 208decision revision under, 208drug allocation as part of, 208–209ethical template for, 209–222Imitrex and, 211–212Medicaid and, 209Medicare and, 209in public health care, 206–207
Philippines, thestem cell research in, 120
PhRMA (Pharmaceutical Research andManufacturers of America), 77, 311,340, 366
physician detailing, 128, 131, 154,181–182. See also sales, drug
“academic,” 181aids for, 154expenditures for, 131
physician package insert. See PIphysicians
clinical research and, role in,26–27
detailing for, 128DTCA and, influence on, 175mistrust of, 139“patient-centered” practices for,
in clinical research, 9–12free market systems and, 10
Prograf, 164Project Inform, 306promotions, drug (prescription). See also
sales, drugfor accelerated approval products,
164–165DTC, 165FDA violations for, 162–164FDCA guidelines for, 159, 166,
167under First Amendment, 184introductory campaigns, 165“off-label” use and, 184, 187–188, 438regulation of, 159–162, 167samples as part of, 158statutory framework for, 185–188types of, 158–159, 164–165US expenditures for (2003), 157–158
Prontosil, 27property rights. See rights, propertyprotease inhibitors
randomized clinical trials. See trials,clinical (randomized)
rare indications. See diseases, rareRatzan, Scott, 130R&D (research and development), 228.
See also drugs, newapproval times for, 296–298for aspirin, 151for AZT, 270, 302, 304for didanosine, 303, 304disease markers in, 297EU pharmaceutical industry
Related Agencies Appropriations ActSCNT under, 112stem cell research and, 112, 427
reminder advertisements, 156–157. Seealso DTCA
“brief summary” as part of, 156reproductive cloning, 111
SCNT v., 111, 115The Rescue Principle
HIV/AIDS and, 381–385IP rights and, 385
research and development. See R&Dresearch, clinical (non-therapeutic)
ethical guidelines for, 41–44guidelines for, 414–415informed consent as part of, 42–43Phase I studies for, 42for vulnerable groups, 43–44
research, clinical (therapeutic), 36children and, 17–18for common diseases, 28costs for, 27–28drug licensing and, 22economic pressures for, 26ethical guidelines for, 9, 26–31, 38–41for malaria, 10medical ethics in, 36participation in, 19–20patient’s rights in, 9, 16–20physician’s role in, 26–27profit maximization in, 9–12for rare diseases, 29scientific ethics in, 36stem cell, 9Tuskegee syphilis study, 17
research, geneticDNA arrays as part of, 91for drug therapies, 91–92GRAD and, 91
research, genomic, 295–296FDA and, 295government role in, 295–296
research participation (clinical)for HIV/AIDS, 19language/cultural barriers to, 19for minorities, 19, 20Tuskegee syphilis study and, 19
research, pediatric (cont.)adverse effects during, undefined, 53CFR on, 57, 59CIOMS on, 57, 68clinical trials for, 48, 51developmental behavior during, 53–54,
56, 290“direct benefit” in, 73–74dosing calculations in, 48ethical guidelines for, 56–62EU Directive on Clinical Trials and,
68as exploitation, 78FDA and, 48government policy for, 49ICH on, 57, 68ineffective dosing in, 52–53ineffective therapies during, 52IRBs for, 60legislative approaches to, 69–70for MDD, 76minimal risks for, 59–62, 71, 72–73NHRPAC and, 60for paroxetine, 76patient condition for, 72–73patient selection for, 70–71Pediatric Rule for, 50pharmacovigilance in, 54–56placebo-controlled clinical trials for,
63–65, 74–75post-approval studies as part of, 56public results of, 51queries for, 58randomized clinical trials for, 62–65regulations for, 49–52“sentinel canaries,” 49as social contract, 75–78variability in, 56
and, 112SCNT as part of, 110in Spain, 119in Sweden, 119in UK, 119–120US government policies for, 109, 118,
122US law and, 111–114
rights, human, 261IP as part of, 261–280
rights, patient’s, 104–107in clinical research, 9, 16–20HIV/AIDS research and, 104–105pharmaceutical industries and, 3under public health care, 171researcher trust and, 101, 104trial participation as part of, 97–100,
and, 38comparator products in, 46didanosine in, 304disclosure as part of, 319–320double-blind, 23, 24ethical review committees and, 45false data in, 315fixed-dose combination drugs and, 38foreign, 98–99funding sources for, 322–324guiding principles for, 318–324ICH and, 45informed consent as part of, 39international documents for, 39for new drugs, 38in New Zealand, 102The Nuremberg Code of 1947 and, 38patient’s rights and, 97–100, 105–106pediatric research and, 48, 51phases for, 46placebo-controlled, 63–65, 407, 416publication of, 46–47randomized (pediatric), 39risk management in, 285side effects during, 468sponsor obligations for, 45–46structured communication during,
320–322trials, clinical (placebo-controlled),
63–65, 407, 416Helsinki Declaration of Ethical
Principles for Medical ResearchInvolving Human Subjects and, 74
mother-to-child HIV transmission, 222for pediatric research, 63–65, 74–75pediatric research and, 74–75priority principle in, 442rationing for, 442risks for, 65for steroids, 74–75WMA and, 64, 74
trials, clinical (randomized)clinical equipoise in, 62–63DMC in, 62IEC input on, 62for pediatric research, 62–65
See also Doha Declaration onTRIPS and Public Health
tropical indications. See diseases, tropicalTrovan, 143tubal embryo transfer. See TETtumour necrosis factor. See TNFα
Tuskegee syphilis study, 17African Americans as part of, 19, 101AP and, 101
UK (United Kingdom)cost guidelines in (new drugs), 238drug price controls in, 327drug recalls in, 25informed consent in, 197innovation output in, 333medical information in, 198–199new drug launches in, 25NHS Direct in, 202Stem Cell Bank in, 119stem cell research in, 119–120
UK Stem Cell Bank, 119UN International Covenant on Civil and
Political Rights (1966), 39UNAIDS (Joint United Nations
Programme on HIV/AIDS), 40“Ethical Considerations in HIV
Preventive Vaccine Research,” 40Universal Declaration of Human Rights
(1948), 40Upjohn, 171US (United States)
AMCP in, 238anthrax in, 267Clean Air Act, 114cloning restrictions in, 118
Contract With America in, 114cost per QALY in, 229Dickey Amendment in, 111drug recalls in, 25–26Energy Security Act, 114Foreign Assistance Act, 114The Global Fund to fight AIDS,
Tuberculosis and Malaria and,contributions to, 341
healthcare expenditures in (2002), 134,225
healthcare literature in, 232–234HIV/AIDS funding in, 341–342Human Cloning Prohibition Act, 113immunization program in, 386–387innovation output in, 333IP rights in, 267–268, 340IVF in, 116, 118MMA in, 239–240new drug launches in, 25Orphan Drug Act, 289Patent Office, 280patent protection in, 227, 350prescription drug sales, international
share, 227prescription drug sales within (2003),
153, 174, 226Public Health Service, 228regulation setting in, 116–118stem cell research in, government
policies for (by state), 118stem cell research in, government
policies for (general), 109, 122stem cell research in, laws for, 111–114Strategic Defense Initiative in, 114Superfund in, 114Trade Act in, 457Veteran’s Health Care Act, 288
US Patent Office, 280US Trade Representative reports. See
USTRUSTR (US Trade Representative)
reports, 339, 457Section 301 watch list in, 339
vaccine development centers. See VDCsVaccine Injury Compensation Program.
See VICPvaccine, polio, 372, 386
Rotary International and, 389–390Salk, Jonas, and, 372