You are on page 1of 24

Science, Ethics and the Pharmaceutical Industry

The Age of High science in American Medicine
1935-

1880 ‡ The golden age of medical practice 19001960 ‡ The golden age of scientific (pharmaceutical) medicine 1935-? .Golden ages ‡ The golden age of public health 1880-1920 ‡ The golden age of surgery. c.

S.3 50. enteritis. 1900-1998. Leading Causes of Death .2 64 72.U.1900 Diphtheria Senility Cancer and other malignant tumors All accidents Nephritis (all forms) Intracranial lesions of vascular origin Diseases of the heart Diarrhea.4 202.3 88.000 population Source: Leading Causes of Death.2 250 Deaths per 100. Centers for Disease Control and Prevention .7 194.6 106.4 142.9 137. and ulceration of« Tuberculosis (all forms) Pneumonia (all forms) and influenza 0 50 100 150 200 40.

Centers for Disease Control and Prevention . 1900-1998.5 Deaths per 100.U. and asthma Certain causes of mortality in early infancy Arteriosclerosis Cirrhosis of liver Diabetes mellitus Influenza and pneumonia Accidents Cerebrovascular diseases Malignant neoplasms.5 15.2 169 346 350 400 Source: Leading Causes of Death.000 population 25. including neoplasms of lymphatic and hematopoietic tissues Diseases of heart 0 50 100 150 200 250 300 12. Leading Causes of Death .S. emphysema.1 15.6 13.7 49 97.6 17.1974 Bronchitis.

including neoplasms of lymphatic and hematopoietic tissues Diseases of heart 0 50 100 150 200 250 10.4 35.9 Deaths per 100.1 285. Centers for Disease Control and Prevention .000 population 35.9 204. Leading Causes of Death .9 56. 1900-1998.9 300 350 Source: Leading Causes of Death.5 11.4 30.S.7 12.1992 Homicide and legal intervention Human immunodeficiency virus infection Suicide Diabetes mellitus Pneumonia and influenza Accidents and adverse effects Chronic obstructive pulmonary diseases and allied conditions Cerebrovascular diseases Malignant neoplasms.2 19.U.

1944: antibacterial agents ‡ Corticosteroids. 1888 ‡ Diphtheria antitoxin. 1891: concept of stimulating immune system ‡ Salvarsan. 1948 . 1935. 1921.Cures ‡ Rabies vaccine. addition of normal bodily substances ‡ Sulphanilimide. penicillin. streptomy cin. 1907 ± 606: concept of toxic receptors ‡ Insulin. 1941.

1940s http://en.org/wiki/File:Karl_Pearson.wikimedia.jpg ‡ Raymond Pearl (1879-1940) ± Application of Pearsonian statistics in medicine. 1830s1840s ± Hospital as an experimental site ± Very large (tractable) patient populations ± Bleeding does not improve pneumonia This image is © Wellcome Images. ‡ Karl Pearson (1857-1936) ± Mathematics of correlation and regression http://commons.wikipedia. available under a Creative Commons License.The emergence of clinical ³SCIENCE´ ‡ The Paris Hospitals.org/wiki/Raymond_Pearl . early 19th century ‡ PCA Louis and the numerical method.

The pharmaceutical industry ‡ Pharmacopeias: lists of recognized medicaments (and modes of preparation): Problems of strength ± ± ± ± ± 11th century Arabia 1618: London Royal College of Physicians 1820: U.org ‡ Proprietaries: Hamlin¶s Wizard oil ‡ "Rheumatism. deafness. bleeding gums...usp. 1938: accepted as legal standards ‡ www. cholera morbus. and just about everything else!" ‡ Ethicals: laudanum Image courtesy of the National Library of Medicine. burns. quinsy. gastralgia. National Institutes of Health. Pharmacopeia 1888: National Formulary 1906. . toothache.. bite s of dog.S. diphtheria.

gif .png http://en.wikimedia.org/wiki/File:Lydia_Pinkham.wikipedia.Lydia Pinkham http://commons.org/wiki/File:LydiaPinkham-VegetableCompound.

chloroform. or any derivative or preparation of any such substances contained therein. alpha or beta eucaine. section 8. heroin. opium. morphine. or acetanilide. cannabis indica. cocaine. If the contents of the package as originally put up shall have been removed. chloral hydrate. or if the package fail to bear a statement on the label of the quantity or proportion of any alcohol. If it be an imitation of or offered for sale under the name of another article. Mislabeling In the case of drugs´ ± FIRST. and other contents shall have been placed in such package.htm . in whole or in part.Regulation of the pharmaceutical industry ‡ Federal Pure Food and Drugs Act.gov/opacom/laws/wileyact.fda. ‡ Problems: Pinkham¶s vegetable tonic (20% alcohol) ‡ Amendment 1912 allows action against ³false and fraudulent´ claims ± Http://www. 1906 (the Wiley Act). ± SECOND.

interest in families of compounds Assumption of structural molecular specificity Little knowledge of HOW drugs work Drug testing in the 1930s ± Safety.Empirical age of pharmacology (to mid 1950s) ‡ ‡ ‡ ‡ Lots of new compounds. but new uses and combinations ± Free-lancers: established clinical scientists ± Efficient: wannabe clinical scientists: practitioners with access to patients ± Friendly experts: the insidious ³general consultant´ ‡ Rasmussen¶s classes .

I do not feel that there was any responsibility on our part. under 1906 act for mislabeling (elixir = alcohol)[ Photo courtesy of U.³ ‡ Fined.S. .Regulation of the pharmaceutical industry/2 ‡ 1937 Sulfanilamide incident: ‡ Elixir Sulfanilamide: sulfanilamide + diethylene glycol + raspberry flavoring ‡ 100 deaths: ‡ Defense ‡ "We have been supplying a legitimate professional demand and not once could have foreseen the unlooked-for results. Food and Drug Administration.

1940s. FDA ± Amendments. to gatekeeper physicians ± After 1980s.Regulation of the pharmaceutical industry/3 ‡ Leads to passage of Foods. to 1951: ‡ lead to prescription-only drugs after 1951 ‡ Requirements for pre-approval testing ‡ Medical Advertising ± After 1951. 1938. est. Drugs. and Cosmetic Act. to public ‡ Back to consumer medicine .

enforced after 1970 ± False positives and negatives ± Risk (or tolerance)-benefit ratio ± Presumption of universal human ‡ State interests in citizenry vs therapeutic liberty ± Ecological interests ± veterinary antibiotic use ‡ Inability to choose ± OTC vs prescription . 1962.It¶s my body: why not let me choose? ‡ Problem of drugs. diagnostic techniques ± Efficacy.

Meaningful long-term follow-up ‡ Problematic before serology: large numbers mask ‡ Complicated conceptually in epidemiology and ethically in treatment trials ‡ Presumes biomedical model of cure ‡ Requires standardized modes of measurement ‡ Requires enormous commitment of social workers. Diagnostic accuracy ± Disease + patient + stage ‡ 2.Controlled trials (and epidemiology) ‡ 1. Elimination of bias ideally double blind ‡ 4. statisticians: Even necessary? . agreed measures of success ‡ 5. Meaningful control ‡ 3.

Hubert ± Gottlieb¶s instruction: follow the Protocol ± Sondelius¶ capitulation: follow Gottlieb ± Arrowsmith¶s capitulation: save lives.The concept of clinical trials ‡ Arrowsmith¶s trials of plague antidote: St. sacrifice science ‡ The Reception of Arrowsmith: science is a hard but noble master .

Federal funding of medical research ‡ Pre WWII ± Rockefeller Foundation ‡ Rockefeller Institute. 1935 ‡ Theobald Smith. Public Health Service Hygienic Institute ‡ Joseph Kinyoun ‡ Goldberger. New York ± A De Witt Tubbs/Simon Flexner ‡ Carnegie Foundation ± Flexner Report ± U.S. pellagra. Rocky Mountain Spotted Fever .

hhs. 3 million ± 1951 76 million ‡ National heart institute.6 mil by 1962). television violence. 1948.gov/ophs/ . NIMH 1949 (374K to 42.Federal funding/ 1930 NIH (Bethesda. leads to CDC 1946 ‡ 1950 NSF: peer review grants ‡ overall fed expenditure on medical research ± 1941 c. artificial quinine. alcoholism ‡ Separation of Surgeon General¶s office 1968 ± http://www. juvenile delinquincy. 1938) 2 ‡ 1937 National Cancer Institute ² grants to outside researchers ‡ 1941 Committee on Medical Research : mass production of malaria. ‡ Child development. suicide prevention.

.Image courtesy of Office of NIH History. National Institutes of Health.

gov/icd/index.nih.27 Institutes: How many do you know? ‡ ‡ ‡ ‡ ‡ ‡ ‡ ‡ ‡ ‡ ‡ ‡ ‡ NCI NEI NHLBI NHGRI NIA NIAAA NIAID NIAMS NIBIB NICHD NIDCD NIDCR NIDDK ‡ ‡ ‡ ‡ ‡ ‡ ‡ ‡ ‡ ‡ ‡ ‡ ‡ ‡ NIDA NIEHS NIGMS NIMH NINDS NINR NLM CIT CSR FIC NCCAM NCMHD NCRR CC http://www.html .

8 m ‡ 1945 180. .Federal funding/3 1938 usphs total = 2.000 for research alone ‡ 1947 4 million for research alone ‡ 1950 46 m for NIH alone ‡ 1955 81 m ³ ‡ 1960 400 m ³ ‡ no similar funding for increasing medical education.

1952: an upper class disease ‡ American Cancer Society. 1937 ² march of dimes ‡ Salk vaccine. . (Mary Lasker)1948-49 Mary Lasker in front of one of her paintings Photo courtesy of the National Library of Medicine.The politics of public medicine: medical advocacy ‡ National Foundation for Infantile Paralysis. National Institutes of Health.

Credits Slide 8 ‡ ‡ ‡ Pierre Charles Alexandre Louis 1787-1872. In the public domain.wikipedia. 2010.nih.gov/default.gov/exhibits/history/docs/page_07a.png on August 9.jpg on August 9. In the public domain. 2010.nih. Accessed from http://images. Accessed from http://www. Accessed from http://en.jpg on August 9.uk/ on August 9. Slide 9 ‡ ‡ ‡ Slide 10 Slide 13 ‡ ‡ Slide 20 Slide 23 ‡ .fda.org/wiki/File:Lydia_Pinkham. In the public domain.gov/ on August 9. In the public domain.htm on August 9. In the public domain. 2010. Accessed from http://profiles.org/wiki/File:Raymond_Pearl_o.wellcome.nih.nlm. Hamlin's Wizard Oil. 2010. In the public domain.wikipedia.gov/TL/B/B/D/C/_/tlbbdc. 2010.gif on August 9.nlm.org/wiki/File:LydiaPinkham-VegetableCompound. Lydia E. Photo of Karl Pearson. Pinkham¶s Vegetable Compound. 2010.history. NIH Org Chart 1949. Accessed from http://commons. Accessed from http://www. 2010.jpg on August 9. In the public domain. Photo of Raymond Pearl. Lydia E. Accessed from http://en. In the public domain. Accessed from http://commons. ccby-nc-sa. Accessed from http://www. 2010.wikimedia. Pinkham¶s Herb Medicine. B&W photo of Mary Lasker. Bottle of Sulfanilamide.wikimedia.org/wiki/File:Karl_Pearson. 2010.html on August 9.ac.