INDEX

Abbott

Enlight Biosciences and

fines levied against

philanthropy

R&D budget cuts

Abramson, John

Academic institutions, collaborating with

Accountability

ACE inhibitors. See Angiotensin converting enzyme (ACE) inhibitors

Acetaminophen

Acetylsalicylic acid

Actos

AD. See Alzheimer’s disease

Adverse Event Reporting System

Advertising

direct-to-consumer

FDA guidelines

television

AIDS

AIM-HIGH trial

Aldose reductase inhibitors

Alimta

Aliskerin

ALK. See Anaplastic lymphoma kinase

Allergic reactions

Alli

Alnylam, R&D budget cuts

Alpha blockers

Alprostadil

ALTITUDE study

Alzheimer’s Association

Alzheimer’s disease

cost of care for

rising incidence of

American Cancer Society

American College of Obstetricians & Gynecologists

American Heart Association

“America’s Innovative Agency: The FDA” (Hamburg)

“America’s Most Generous Companies” (Smith)

Anacetrapib

Anaplastic lymphoma kinase

Anemia, Recormin for

Angell, Marcia

Angiotensin

Angiotensin converting enzyme (ACE) inhibitors

Anglo-Scandinavian Cardiac Outcomes Trial

Anti-BAFF antibody

Antibacterial R&D, less investing in

Antibiotics

bacterial resistance and

novel, GAIN Act and

Antidepressants

Antihistamines

Antipsychotics

Apixaban

Arrowsmith, John

Arthritis

ASCOT. See Anglo-Scandinavian Cardiac Outcomes Trial

Aspirin

AstraZeneca

Enlight Biosciences and

R&D budget cuts

tuberculosis campaign

Atherosclerosis

Atorvastatin

Attention deficit disorder medicines

Avanafil

Avandia

AVEO Pharmaceuticals

Avorn, Jerome

Azithromycin

Bachmann, Michele

Bacterial infections

Bacterial resistance

Bapineuzumab

Bardoxolone

BBC News

Benadryl

Benign prostatic hyperplasia, saw palmetto and

Benjamin, Regina

Benlysta

Beta-adrenergic receptor blockers

Beta blockers

Big pharma. See also Drug companies

Big pharma

early research collaborations

rare diseases and

restoring image of

Bill & Melinda Gates Foundation

Biofind

Biomarkers

Biopharmaceutical industry, major impacts on

Biopharmaceutical R&D

cancer treatments and cutbacks in

productivity of

Biotech companies, R&D budget cuts

BioWorld

Bisphosphonates, risk-benefit profile of

“Bitter Pill for Big Pharma, A” (Petersen)

Blockbusters

changing mentality around

defined

niche

predicting, difficulty in

Blood-pressuring drugs

BMI. See Body mass index

BMJ. See British Medical Journal

BMS

Body mass index

Boger, Joshua

Boldrin, Michele

Bone loss

BPH. See Benign prostatic hyperplasia

Brain diseases

Bristol Myers, merger with Squibb

Bristol-Myers Squibb

British Medical Journal

Brody, Howard

Brody, Jane

Budget sparing, outsourcing and

Bulbulia, Richard

Bupropion

Butte, Atul

C-reactive protein, lowering, Crestor and

Cafepharma

Cancer

bundling medications for

as chronic vs. fatal disease

FDA and new drugs for

mortality rates for

targeted therapies for

Cancer medications, cost of

Cancer research

“golden era” of

during 1990s

Cancer Research UK

Cannon, Christopher

Capacity generating, outsourcing and

Cardiovascular disease

niacin therapy and

risk factors for

in United States

CARDS study

Cardura

Carpenter, Daniel

CDC. See Center for Disease Control

CDP. See Coronary Drug Project

Center for Disease Control

Centers for Therapeutic Innovation, at Pfizer

Central nervous system (CNS) research, averting “dead space” in

Cerezyme

Cervical cancer, human papilloma virus and

Cetirizine

CETP. See Cholesteryl-ester transfer protein

CFTR

Chantix

Chemical entities, new, launched in U.S.

Chemotherapy, new agents

Chinese herbal medicines

Chlamydia trachomatis

Cholesterol levels

Cholesteryl-ester transfer protein, finding inhibitors of

Chronic diseases, FDA approved drugs and

Chronicle of Philanthropy, The

Cialis

Claritin

Clinical development programs, studies and costs tied to

Clinical outcomes, predicting, difficulty in

Clinical trials

data in public registries

drug company funding for

high placebo efficacy rates in, for psychiatric disorders

transparency and

ClinicalTrials.gov

Clostridium difficile

Collaboration

academic institutions and

precompetitive

Collins, Francis

“Comparative Effectiveness of Weight-Loss Interventions in Clinical Practice”

Consultants

Contrave

Coronary Drug Project

Corporate reputation, drug pricing, profitability and

Cost-cutting culture, R&D and

Coukell, Allan J.

Credibility

Crestor

Crizotinib

Crum, Alia

CVD. See Cardiovascular disease

Cynicism

Cystic fibrosis

“Cytisine for Smoking Cessation” (Etter)

Cytisine preparation, smoking cessation and

Cytisus laborinum L, poisoning incidents and

Cytosine

DALYs. See Disability adjusted life years

Dana Farber Cancer Institute

Dapaglifloxin

Darapladib

Data Safety Monitoring Board

Davis, Pamela

“Debate Re-ignites Contribution of Public Research to Drug Development”

“Decade of the Brain”

Deen, Paula

Dementia, Ginkgo biloba trial and

Department of Health and Human Services

Depression

healthy diet, active lifestyle and

major

Diabetes

FDA and new drugs for

healthy diet, active lifestyle and

Diet

cardiovascular disease and

obese population and

Diet drugs, FDA and stance on

Dietary supplements, U.S. sales of

Dificid

Diflucan

Diphenhydramine

Direct-to-consumer advertising

Disability adjusted life years, mental illness and

Discovery, productivity and

Discovery industrialization, success of

Disease, worldwide burden of, disability adjusted life years

“Disease creep”

“Disease Creep: How We’re Fooled into Using More Medicine Than We Need” (Lenzer)

“Disease mongering”

Diuretics

Doctors, as gatekeepers for patients’ medications

Doshi, Peter

Downsizing

Doxepin

DPP-IV inhibitors

Dr. Oz Show, The

“Dr. Oz’s Four Secrets”

Drug approvals, from companies that no longer exist. See also Food and Drug Administration

Drug “cocktails”, for cancer

Drug companies

controlling information your doctor gets

prescribing drugs you don’t need

targeting symptoms, not causes

underestimating dangerous side effects and

Drug delivery technology

Drug lags

Drug repositioning, filling R&D pipeline and

Drug reprofiling

Drug repurposing

Drug-resistant pathogens

Drug Truths—Dispelling the Myths About Pharma R&D (LaMattina)

Drugs

discovery of

perspective on

“shots on goal” philosophy in

illegal detailing of

price regulation for

risk–benefit profiles of

DSMB. See Data Safety Monitoring Board

Dyslipidemia

ED. See Erectile dysfunction

Effectiveness of drugs, transparency and

Eisai, malaria campaign

Ekblom, Anders

Eli Lilly

Enlight Biosciences and

fines levied against

philanthropy

strong R&D investments at

tuberculosis campaign

Employees, mergers and social consequences on

Enlight Biosciences, partners invested in

Entrega

“Epidemic of Mental Illness–Why?, The”, (Angell)

Erectile dysfunction

drugs for

TV ads for

Etter, J. F.

European College of Neuropsychopharmacology

Exercise

cardiovascular disease and

obese population and

Famotidine

FDA. See Food and Drug Administration

Federal deficit, NIH budget cuts and

Federal Trade Commission

Fen-phen

Fertility rates, placebos and

Fidaxomicin

Financial toxicity

Fines, for illegal marketing practices

Firestone, Raymond

Fisons

5-lipoxygenase inhibitors

Food and Drug Administration

advertising guidelines

declining number of approvals by

diabetes drugs and

drug approval system of

drug sponsors and

heightened requirements for NDAs by

new antibiotics and

new drug approvals by

new medical entities approved by

rolling 10-year drug approvals

safety data requirements by

unfair criticisms of

Vertex approved by

Fortune magazine

“Four Secrets That Drug Companies Don’t Want You to Know” (Oz)

Framingham Heart Study

Frazier, Kenneth

Freund, John

FTC. See Federal Trade Commission

Funtleyder, Les

Fusion mergers

GAIN Act

Gamma secretase inhibitors

Garber, Judy

Gardasil

Gaucher disease

Gender, cancer mortality rates and

Generic drugs

cost of

safety issues and

Genetically targeted drugs

Genzyme

Gingko Evaluation of Memory (GEM) trial

Ginkgo biloba

GlaxoSmithKline

Avandia sales and

fines levied against

malaria campaign

rare diseases and

tuberculosis campaign

Globalization

Goddard, Colin

Goodwin, Guy

Gottlieb, Scott

“Grasping for Any Way to Prevent Alzheimer’s”

Grassley, Chuck

Growth

Gutierrez-Ramos, Jose Carlos

Ha-Ngoc, Tuan

Hajek, Peter

Hamburg, Margaret

Hamilton Rating Scale for Depression

Hausen, Harald zur

HDL cholesterol

Health-care system, War on Cancer and

Heart attacks

Heart disease

deaths attributable to, in U.S.

FDA and new drugs for

Heart Protection Study (HPS) Collaborative Group

Herbal medicines

Herper, Matthew

HGS. See Human Genome Sciences

High-throughput screening

Hiring freezes

Hirth, Peter

HIV drugs, FDA approval of

Hoechst

Hogan, Melissa

HPV. See Human papilloma virus

HRSD. See Hamilton Rating Scale for Depression

HTS. See High-throughput screening

Human Genome Project

Human Genome Sciences

Human papilloma virus, cervical cancer and

Hypertension drugs

Ibuprofen

IDSA. See Infectious Diseases Society of America

Iduronate sulfatase

IFPMA. See International Federation of Pharmaceutical Manufacturers & Associations

Illegal detailing, of drugs

Imaging techniques

IMT. See Inflammatory myofibroblastic tumor

“In Defense of Antidepressants” (Kramer)

In-licensing

“In the Pipeline” blog (Lowe)

Industry-physician relationship, transparency and

Industry productivity, royalties and

Infectious diseases

global deaths from, leading causes of

Infectious Diseases Society of America

Inflammatory myofibroblastic tumor, ALK oncogene and

Influenza

Inlyta

Innovation

Intellectual property

International Federation of Pharmaceutical Manufacturers & Associations

International Trachoma Initiative

Iressa

“Is Declining Innovation in the Pharmaceutical Industry a Myth?” (Schmid and Smith)

ITI. See International Trachoma Initiative

Ivacaftor

Ivermectin

JAK-3

JAMA. See Journal of the American Medical Association

Janumet

Januvia

Jarvik, Robert

Jefferson, Tom

Johnson & Johnson

Enlight Biosciences and

philanthropy

in top 10 of Fortune’s list

Journal of the American Medical Association

Kefauver-Harris Drug Act

Kessler, David

Kidney cancer, drugs for

Kramer, Peter

Kumar, Harpal

Lactose intolerance

Lancet, The

Langer, Ellen

Latanoprost

Lawsuits

Layoffs, mergers and

LDL cholesterol

Lipitor and

lowering

statins and

Leads

Lechleiter, John

Lehman, Richard

Lenzer, Jeanne

Leprosy, thalidomide and

Levitra

Linezolid

Lipid metabolism, PCSK9 and

Lipitor

biochemical profile of Crestor vs.

sales of, at its peak

success of, factors related to

TV ads for

Liver failure, acetaminophen and

Loder, Elizabeth

Loratidine

Lowe, Derek

Lung cancer

ALK gene and

crizotinib and

Mackay, Martin

Major depression

Malaria, combating

Mandel, Michael

Mann, John

Marion Merrill Dow

McKinnell, Hank

Mectizan

“Medical Management of Depression, The” (Mann)

Medicare

Medimmune, Astra Zeneca acquisition of

Melanoma

new therapies for

vemurafenib for

Zelboraf for

Men, cancer mortality rates for

Menon, Rosalyn

Menotabine

Mental illness

Merck

Enlight Biosciences and

philanthropy

river blindness campaign

in top 10 of Fortune’s list

Mergers

R&D productivity and impact of

social consequences of, on employees

Methicillin-resistant Staphylococcus aureus

Miller Taback Health Care Transformation Fund

Misoprostil

Moynihan, Ray

MPS. See Mucopolysaccharidosis

MRSA. See Methicillin-resistant Staphylococcus aureus

Mucopolysaccharidosis

Multiple sclerosis

Muscular dystrophy

Naltrexone

Nanotechnology

Naproxen

National Alzheimer’s Project Act

National Cancer Act

National Cancer Institute

National Health Service, Britain

National Institutes of Health

antibacterial R&D and

biomedical research funding and

budget cuts at

diabetes drug development and

rare diseases defined by

Native American healers

Nature

Nature Biotechnology

NaV1.7

NDAs. See New Drug Applications

Negative data, credibility of pharmaceutical industry and

Nerve growth factor

Neuroscience research, scaling back on, reasons for

“New Bargain for Drug Approvals, A” (Boldrin and Swamidass)

New development project success rates

New Drug Applications

filing

heightened FDA requirements for

New England Journal of Medicine, The

New medical entities, FDA approval of

New York Review of Books, The

New York Times

Nexavar

NGF. See Nerve growth factor

Niacin

heart disease and debate over

side effects with

“Niacin at 56 Years of Age—Time for an Early Retirement

Niblack, John

Niche blockbusters

Nicotine

Nicotine partial agonists

NIH. See National Institutes of Health

Nissen, Steven

Nitrous oxide

Nixon, Richard

NMEs. See New medical entities

NO. See Nitrous oxide

Non-Hodgkin’s lymphoma, ALK-positive

Nonsteroidal anti-inflammatory drugs

Norvasc

Novartis

malaria campaign

tuberculosis campaign

Novel drugs, recently approved and in pipeline

Novo Nordisk, Enlight Biosciences and

NSAIDs. See Nonsteroidal anti-inflammatory drugs

Nutt, David

Obama, Barack

Obama administration, Alzheimer’s disease research and

Obesity

FDA and new drugs for

type 2 diabetes and

“Off the Mark” (Parisi)

Omeprazole

Oncogene Sciences Institute

Oncogenes

Onyx

Optimer Pharmaceuticals

Orexigen

Orlistat

Orphan diseases

Osborne, John

Osteoarthritis, healthy diet, active lifestyle and

Osteopenia

Osteoporosis

FDA and new drugs for

healthy diet, active lifestyle and

Outcome studies

Outsourcing

pharma R&D and

purposes of

Overdosed America (Abramson)

Oz, Dr.

PAF. See Platelet activating factor

Pain

Pain sensitivity, treating

Parisi, Mark

Pathogens, drug-resistant

Payers, higher hurdles set by

PCSK-9 antibody

PCSK-9 blockers

PDE-5 inhibitors

PDUFA. See Prescription Drug User Fee Act

Peanut allergies

Pepcid

Pereira, Dennis

Permutter, Roger

Perry, Rick

Petersen, Melody

Pfizer

CARDS study

Centers for Therapeutic Innovation

Enlight Biosciences and

fines levied against

Lipitor’s success and

malaria campaign

new

oncology pipelines at

philanthropy

pipeline updates

rare diseases and

R&D budget cuts

“Science Ambassadors” program at

“shots on goal” philosophy at

size and productivity at

substance P antagonists and

in top 10 of Fortune’s list

Pharmaceutical companies, TV ads and

Pharmaceutical industry

consolidation of

R&D cuts and

Pharmaceutical Research and Manufacturers Association

Pharmacia

Pharmacoeconomics groups

Pharmacovigilance programs

Phase 4 studies

Phenothiazines

Phenotypic screening

Philanthropy, pharmaceutical companies and

PhRMA. See Pharmaceutical Research and Manufacturers Association

PHT. See Pulmonary hypertension

Pipelines

“industrialized” methodology and

mergers, reorganizations and

outsourcing and

“Placebo-Controlled Trial of Cytisine for Smoking Cessation”

Placebo efficacy rates, high, in clinical trials for psychiatric disorders

“Placebo Response in Studies of Major Depression”

Platelet activating factor

Plavix

Plexxikon

Poison Control Center

Polysaccharides, incomplete breakdown of

Precompetitive collaborations

Predictive innovation, success rates and

Prescription Drug User Fee Act

Prices of drugs, regulation of

Prilosec

Productivity

discovery and focus on

mergers and impact on

surge in

Progressive Policy Institute

Promoting drugs, for labeled indications

Prostaglandins

Psoriasis, tofacitinib and

Psychiatric disorders, high placebo efficacy rates in clinical trials for

Psychiatric medications, controversy over

Public confidence, restoring

Public registries, clinical trial data entered into

Public sector research, number of drug approvals rooted in

Pulmonary hypertension, primary

PureTech Ventures

Queen Mary University Hospital, London, Tobacco Dependence Unit

Rare diseases, big pharma and

Rasilez

R&D

budget cuts in

consolidations and turmoil in

cost-cutting culture and

evolutionary thinking in

identifying fatal flaws in compounds

need for substantial investment in

outsourcing and

productivity

current critics of

heightened FDA requirements for NDAs and

higher hurdles set by payers and

mergers and impact on

size and

science ambassadors and

R&D pipeline, drug repositioning and

Read, Ian

Recormin, for anemia

Redfern, David

“Reminder on Maintaining Bone Health, A” (Brody)

Renin-angiotensin (RAS) cascade

Renin inhibition

Reorganizations, R&D divisions and

Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA (Carpenter)

Resource pooling

Return on investment

Reusable drugs

Revatio

Rezulin

Rheumatoid arthritis, tofacitinib for

Rhone-Poulenc

Rinat

Risk-benefit profiles

River blindness

Roche

Rockoff, Jonathan

ROI. See Return on investment

“Role of Public-Sector Research in the Discovery of Drugs and Vaccines, The”

Rorer

Rosenthal, Elisabeth

Rosuvastatin

Roussel-Uclaf

Royalties, scientific productivity and

Rumors

Russell, Angus

Safety data, FDE requirements for

Sage Therapeutics

Salicylic acid

Sanofi-Aventis

Genzyme acquired by

malaria and tuberculosis campaigns

SATURN trial

Saw palmetto

Saw Palmetto Treatment for Enlarged Prostates (STEP) trial

Scannell, Jack

Schering-Plough

Schizophrenia

Science ambassadors

Scripps Research Institute, Pfizer collaboration with

Searle

Semagacestat

Serenoa repens

SGLT2

Sheskin, Jacob

“Shots on goal” philosophy, at Pfizer

“Should Patents on Pharmaceuticals Be Extended to Encourage Innovation

Side effects

Sildenafil

Silverman, Ed

Simpson, Stephen D.

Simvastatin

Singulair

Sitagliptin

Site closures

Size

benefits of

negative aspects of

R&D productivity and

Skyline Ventures

Smith, Jacquelyn

Smoking addiction, treating

Smoking cessation, cytisine preparation and

Southworth, Paul

Squibb, Bristol Myers merger with

St. John’s wort

Statins

Stipp, David

Stroke

Substance P antagonists

Super Bowl commercials

Sutent, for kidney cancer

Swamidass, S. Joshua

Synergy (downsizing)

Synthelabo

T/A, study results for. See also Atorvastatin; Torcetrapib

Tabex

“Take Two Possibly Lethal Pills and Call Me in the Morning” (Stipp)

Tamiflu

Tanezumab

Tarceva

Targeted drugs

Taylor, Edward C.

Tedizolid

Tekturna

Television advertising

Thalidomide, repositioning of

“Therapy for Cystic Fibroses—The End of the Beginning”

Thomson Reuters

Time magazine

Tivozanib

Tofacitinib

Torcetrapib

Torreele, Els

Trachoma

Traditional medicines, modern drug industry and

Transparency, need for

“Treating to New Targets” study

Triglycerides

Trius Therapeutics

Tropical diseases

Tuberculosis, combating

“Two-Year Randomized Trial of Obesity Treatment in Primary Care Practice, A”

Tylenol

Type 2 diabetes

increase in, globally

obesity and

UNICEF

United States

deaths attributable to heart disease in

increase in obesity and Type 2 diabetes in

new chemical entities launched in

Upjohn

Varenicline

Vasodilation, sildenafil and

Vemurafenib, for melanoma

Vertex

Viagra

Victoza

Victrelis

Viehbacher, Chris

Vioxx

Vitamin B3

Vivus

Wall Street Journal

Wang, Shirley

War on Cancer

new business models and

research funded by

Warner-Lambert Parke-Davis

Weight loss

FDA and new drugs for, 35, 36, 37.

obese population and

placebos and

West, Robert

Weyland, Simone

“Why Placebos Work Wonders” (Wang)

Williams, John

Williams, Mike

Winfrey, Oprah

Women, cancer mortality rates for

Woodcock, Janet

World Bank

World Health Organization

Wyeth, R&D budget cuts

Xalkori

Xanax

Xarelto

Xenical

Yervoy

Zantac

Zelboraf, for melanoma

Zithromax

Zocor

Zoloft

Zyprexa

Zyrtec

Zyvox