ostensible bayh-dole goal=more and better drugs, but … trypanosomiasis: 2 drugs, 1 of which,...

Ostensible Bayh-Dole Goal=More and Better Drugs,

but … Trypanosomiasis: 2 drugs, 1 of which, Melarsoprol, a

compound of arsenic and antifreeze, is quite dangerous. The safe, effective medication eflornithine is generally unavailable in Africa, but is sold …

For facial hirsutism: 8 drugs, including Vaniqa, neé Ornidyl, which is eflornithine

MDRTB kills 1.7 million: 5 mainstay drugs

Malaria killed 247 million in 2006: 8 drugs (some date from the 17th century)

ED has killed 0 (although 570 men have died from drugs to treat it)

At least 14 ED drugs have been marketed since 1996

04/21/23Copyright Harriet A. Washington 2

Patent primacy Spurs Harmful Drugs

Violates Non-maleficence: The preferential promulgation of ineffective or harmful medications and treatments

Violates Autonomy: Hobson’s choice for underserved subjects; Research sometimes dispenses with presumed consent, e.g., 50.24 research, tissue surrender

Violates Informed consent: IC “exceptionalism”: PolyHeme, 50.24, tissue surrender, research in the developing world,

Violates Beneficence: The withholding of (or discouraging research into possibly) beneficial medications and treatments Kano

Harmful Drugs, con’t. Violates Justice, e.g. The Global South facilitates cheap rapid

research for the West but is denied access to the treatments that arise; subjecting the Third World to risks Westerners are not asked to undertake; refusing to test medications for disease such as tropical diseases, that afflict the developing world

Violates Dignity e.g., Compulsory research subjects of studies such as those with anthrax shots artificial blood or postmortem tissue retrieval with which they may have objected on religious or visceral grounds

Violates Honesty e.g., presumed consent victims and their families are deceived so are 50.24 subjects such as those in the ROC

Undermines Professionalism and the supererogatory virtues of the physician

Showdown at the Border: Canadians

Patented Prices Board

Erbitux standoff

Bayer sues Thunder Bay, et al. (Cipro)

04/21/23Copyright Harriet A. Washington

5John Colacci

Greed is good? ICELAND

Icelanders Sold their genetic birthright for promises of disease cures , national prestige and fortune, none of which materialized.

Since DeCODE’s bankruptcy and reorganization, the people of Iceland find their linked genome and medical histories in the hands so a private corporation.

DeCode CEO: IC concerns “a crock of sh-t”


6

African Americans/Hispanics/Native

Americans Disproportionately recruited by 50. 24

exception research on PolyHeme; presumed consent schemes to obtain tissues

Bad genetic science coupled with patent greed— BiDil

Havasupai of Grand Canyon

Tristan de Cunha natives


7

Patents vs. Liver Cancer

LIVER CANCER: AA Hepatitis C twice the rate of general US population; major reason for liver transplants mostly cirrhosis, liver cancer.

Chiron’s patent blocked Murex HCV tests in UK

Chiron’s licensing policies exerted a chilling effect on research treatment in US. Reversal is good, but a chimerical whim of corporation could be reversed at any time.

Interferon treatment doesn’t work for most African Americans can’t research it without paying hefty licensing fees to Chiron


8

Patents Discourage Needed Treatments


9Dr. Chris Parish

The case of PI-88

BRCA and young AA Breast cancer 1) expense 2) Dominique Stoppa of

the Curie Institut discovered Myriad’s ~$3 K tests allowed large gaps in detecting BRCA risk, but Myriad prevented research into them to bar the use of the more inclusive tests. Young black women have highest risk of cancer from BRCA mutations


10

Developing World Cannot afford expensive branded Western medications

Tacit prohibition against testing medicines for use against tropical diseases

Per Michael Kremer and NEJM:Of the 1,233 drugs licensed globally between 1975 and 1997, only 13 targeted diseases that strike in the tropics. Only 4 were human medications for use by people who live there.


11

Developing World: Research Epicenter

Attractive to large corporations that fund treatment research

One in three US clinical-study sites is located abroad

Cheaper, faster, fewer regulations/protections

Helsinki Declaration was “modernized,” i.e., diluted in 2002

HIV, Pfizer’s Trovan. Etc.


12

Exportation of exploitation

Abusive medical research is burgeoning in the developing world.

Conducted by U.S. researchers Disparate distribution of risk and benefitEthical relativism; double ethical standardE.g., Thalidomide is backConflation of treatment and researchThalidomide is in at least 36 ongoing

research studies in the developing world— with the FDA’s blessing.

Unconscious trauma patients (CFR 20.24), soldiers, (CFR 20. 23(d))prisoners

Polyheme, Hemopure, Abiocor, diazepam, defibrillators, Bioport anthrax vaccine

Racialized risk*ED settings, emergent teststestsMay, 2007: ROC: Escalation May, 2007: ROC: Escalation

to 21,000 US subjectsto 21,000 US subjects Conflation of research,

therapy

Patents Catalyze Erosion of Informed Consent

Research transformationNeo-racial Pharmacogenomics (BiDil, malaria vaccines)

Nonconsensual research (PolyHeme, ROC); economical, completion during shorter trails

Pediatric research (Valium, Psychic drugs, ROC); patent/ monopoly extension

Nonconsensual pediatric research (ROC, Gardisil)


Tissue AppropriationPresumed consent tissues

Ardais

Prostate cancer Dr. William Catalona

Molchan-Sunderland Alzheimer’s Aricept


Children’s Rx:Purchased bias

Does purchased bias render authors of review articles promoting SSRIs for children rendered unreliable

Patent advantage for children’s applications

Biederman of Harvard

Goodwin of NPR

Merck and Elsevier


Distorting ResearchPaul M. Ridker and Jose Torres at HMS

found that two-thirds of industry-sponsored trials published between 2000 and 2005* favored experimental heart drugs or medical devices. Trials funded by nonprofits were as likely to support the drugs or devices as to oppose them.

Bero et al. Found that clinical trials that compare medications are 20 times more likely to favor the one made by the company that funds the research*


Are some corporations‘buying the ethics they need?’

Worry over corporate trinkets such as pens mugs and penlights is misplaced. The most sought-after commodities are medical publications and the opinions of ethicists.

Carl Elliott: Some papers in "Prozac, Alienation, and the Self,” a special issue of The Hastings Center Report critical of the drug industry. Eli Lilly and Company, which manufactures Prozac, withdrew its annual $250,000 gift to the Hastings Center, citing the special issue as its reason. … ‘A savvy CEO will have no problem finding an ethicist to say virtually anything.’

Some ethicists accept funds but insist they maintain objectivity and independence.

Laurie Zoloth, former American Society for Bioethics and Humanities president suggests that the real currency is ‘not financial but the honor and status of corporate consultancies.’

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ostensible bayh-dole goal=more and better drugs, but … trypanosomiasis: 2 drugs, 1 of which,...

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