ostensible bayh-dole goal=more and better drugs, but … trypanosomiasis: 2 drugs, 1 of which,...
TRANSCRIPT
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
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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”
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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
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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
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Patents Discourage Needed Treatments
04/21/23Copyright Harriet A. Washington
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
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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.
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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.
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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)
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Tissue AppropriationPresumed consent tissues
Ardais
Prostate cancer Dr. William Catalona
Molchan-Sunderland Alzheimer’s Aricept
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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
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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*
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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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