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  1. Article ; Online: The ethical limits of physicians' autonomy and the Brazilian Federal Council of Medicine.

    Paumgartten, Francisco José Roma

    Cadernos de saude publica

    2022  Volume 38, Issue 5, Page(s) e00259021

    MeSH term(s) Brazil ; Humans ; Medicine ; Personal Autonomy ; Physicians
    Language English
    Publishing date 2022-06-08
    Publishing country Brazil
    Document type Journal Article
    ZDB-ID 1115730-6
    ISSN 1678-4464 ; 0102-311X
    ISSN (online) 1678-4464
    ISSN 0102-311X
    DOI 10.1590/0102-311XEN259021
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 4981: Show issues Location:
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  2. Article ; Online: Equipoise, placebo in clinical trials and Brazilian Code of Medical Ethics.

    Paumgartten, Francisco José Roma

    Revista da Associacao Medica Brasileira (1992)

    2021  Volume 67, Issue 4, Page(s) 490–495

    MeSH term(s) Brazil ; Clinical Trials as Topic ; Ethics, Medical ; Humans ; Placebos ; Therapeutic Equipoise
    Chemical Substances Placebos
    Language English
    Publishing date 2021-09-07
    Publishing country Brazil
    Document type Journal Article
    ZDB-ID 731969-1
    ISSN 1806-9282 ; 0104-4230 ; 0004-5241 ; 0102-843X
    ISSN (online) 1806-9282
    ISSN 0104-4230 ; 0004-5241 ; 0102-843X
    DOI 10.1590/1806-9282.20200929
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: On the health risks of "hidden poisons on our table", good agricultural practices, pesticide residues in food, and dietary exposure assessments.

    Paumgartten, Francisco José Roma

    Cadernos de saude publica

    2021  Volume 37, Issue 5, Page(s) e00062221

    MeSH term(s) Brazil ; Dietary Exposure ; Humans ; Pesticide Residues/analysis ; Pesticide Residues/toxicity ; Pesticides/toxicity ; Poisons
    Chemical Substances Pesticide Residues ; Pesticides ; Poisons
    Language English
    Publishing date 2021-05-28
    Publishing country Brazil
    Document type Letter ; Comment
    ZDB-ID 1115730-6
    ISSN 1678-4464 ; 0102-311X
    ISSN (online) 1678-4464
    ISSN 0102-311X
    DOI 10.1590/0102-311X00062221
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Equipoise, placebo in clinical trials and Brazilian Code of Medical Ethics

    Francisco José Roma Paumgartten

    Revista da Associação Médica Brasileira, Vol 67, Iss 4, Pp 490-

    2021  Volume 495

    Keywords Medicine (General) ; R5-920
    Language English
    Publishing date 2021-09-01T00:00:00Z
    Publisher Associação Médica Brasileira
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article ; Online: On the health risks of “hidden poisons on our table”, good agricultural practices, pesticide residues in food, and dietary exposure assessments

    Francisco José Roma Paumgartten

    Cadernos de Saúde Pública, Vol 37, Iss

    2021  Volume 5

    Keywords Medicine ; R ; Public aspects of medicine ; RA1-1270
    Language English
    Publishing date 2021-05-01T00:00:00Z
    Publisher Escola Nacional de Saúde Pública, Fundação Oswaldo Cruz
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  6. Article ; Online: The tale of lenalidomide clinical superiority over thalidomide and regulatory and cost-effectiveness issues.

    Paumgartten, Francisco José Roma

    Ciencia & saude coletiva

    2019  Volume 24, Issue 10, Page(s) 3783–3792

    Abstract: In April 2017, the National Sanitary Surveillance Agency (ANVISA-Brazil) approved lenalidomide (LEN) for multiple myeloma (MM) and myelodysplastic syndrome. ANVISA had rejected the first application in 2010, and denied a request for reconsideration in ... ...

    Abstract In April 2017, the National Sanitary Surveillance Agency (ANVISA-Brazil) approved lenalidomide (LEN) for multiple myeloma (MM) and myelodysplastic syndrome. ANVISA had rejected the first application in 2010, and denied a request for reconsideration in 2012. The reason for rejection was the lack of comparative effectiveness studies proving that LEN was more effective than thalidomide (THAL), a strictly controlled drug regulated by Federal law 10.651/2003 and dispensed to patients (at no costs) through public health system units and hospitals. ANVISA unexplained retreat on the LEN approval for marketing was an unquestionable triumph of the lobbying that ensued the denial, at the forefront of which were politicians, Congress members, patient organizations and medical societies. Two randomized (phase III) trials and three observational (case-control and population-based cohort) compared the effectiveness of THAL- versus LEN-based therapies in MM. Overall, these studies showed no difference in efficacy between LEN- and THAL-based therapies. LEN caused less neuropathy, and more severe hematologic adverse effects. It is much costlier than THAL, and substitution of THAL by LEN shall raise considerably public healthcare costs in Brazil.
    MeSH term(s) Angiogenesis Inhibitors/administration & dosage ; Angiogenesis Inhibitors/adverse effects ; Angiogenesis Inhibitors/economics ; Brazil ; Cost-Benefit Analysis ; Drug Costs ; Drug and Narcotic Control ; Humans ; Lenalidomide/administration & dosage ; Lenalidomide/adverse effects ; Lenalidomide/economics ; Multiple Myeloma/drug therapy ; Multiple Myeloma/economics ; Myelodysplastic Syndromes/drug therapy ; Myelodysplastic Syndromes/economics ; Randomized Controlled Trials as Topic ; Thalidomide/administration & dosage ; Thalidomide/adverse effects ; Thalidomide/economics ; Treatment Outcome
    Chemical Substances Angiogenesis Inhibitors ; Thalidomide (4Z8R6ORS6L) ; Lenalidomide (F0P408N6V4)
    Language English
    Publishing date 2019-09-26
    Publishing country Brazil
    Document type Comparative Study ; Journal Article
    ZDB-ID 2078799-6
    ISSN 1678-4561 ; 1413-8123
    ISSN (online) 1678-4561
    ISSN 1413-8123
    DOI 10.1590/1413-812320182410.28522017
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Ethical issues in placebo-controlled trials of COVID-19 vaccines.

    Oliveira, Ana Cecilia Amado Xavier de / Paumgartten, Francisco José Roma

    Cadernos de saude publica

    2021  Volume 37, Issue 6, Page(s) e00007221

    MeSH term(s) Brazil ; COVID-19 ; COVID-19 Vaccines ; Ethics, Medical ; Humans ; SARS-CoV-2
    Chemical Substances COVID-19 Vaccines
    Language English
    Publishing date 2021-06-04
    Publishing country Brazil
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 1115730-6
    ISSN 1678-4464 ; 0102-311X
    ISSN (online) 1678-4464
    ISSN 0102-311X
    DOI 10.1590/0102-311X00007221
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    In stock of ZB MED Cologne/Königswinter

    Zs.A 4981: Show issues Location:
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  8. Article ; Online: The return of amphetamine-like anorectics: a backward step in the practice of evidence-based medicine in Brazil.

    Paumgartten, Francisco José Roma

    Cadernos de saude publica

    2017  Volume 33, Issue 10, Page(s) e00124817

    Language English
    Publishing date 2017--26
    Publishing country Brazil
    Document type Journal Article
    ZDB-ID 1115730-6
    ISSN 1678-4464 ; 0102-311X
    ISSN (online) 1678-4464
    ISSN 0102-311X
    DOI 10.1590/0102-311X00124817
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  9. Article ; Online: On the antiviral activity and developmental toxicity of 6-methylmercaptopurine riboside (6MMPr).

    Paumgartten, Francisco José Roma

    International journal of antimicrobial agents

    2017  Volume 50, Issue 5, Page(s) 695–696

    MeSH term(s) Animals ; Antiviral Agents/adverse effects ; Antiviral Agents/toxicity ; Female ; Fetal Development/drug effects ; Humans ; Methylthioinosine/adverse effects ; Methylthioinosine/toxicity ; Pregnancy
    Chemical Substances Antiviral Agents ; Methylthioinosine (342-69-8)
    Language English
    Publishing date 2017-09-07
    Publishing country Netherlands
    Document type Letter
    ZDB-ID 1093977-5
    ISSN 1872-7913 ; 0924-8579
    ISSN (online) 1872-7913
    ISSN 0924-8579
    DOI 10.1016/j.ijantimicag.2017.09.003
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 3368: Show issues Location:
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  10. Article ; Online: Ethical issues on the "synthetic" phosphoethanolamine clinical trial.

    Paumgartten, Francisco José Roma

    Revista da Associacao Medica Brasileira (1992)

    2017  Volume 63, Issue 5, Page(s) 388–392

    Abstract: Notwithstanding its approval by the National Committee for Ethics in Research (Conep) on April 19, 2016, a trial of the so-called "synthetic" phosphoethanolamine (syn-phospho) pill in cancer patients raises ethical concerns. An analysis by a laboratory ... ...

    Abstract Notwithstanding its approval by the National Committee for Ethics in Research (Conep) on April 19, 2016, a trial of the so-called "synthetic" phosphoethanolamine (syn-phospho) pill in cancer patients raises ethical concerns. An analysis by a laboratory contracted by the Ministry of Science, Technology and Innovation (MCTI) revealed that syn-phospho contained a great amount of impurities and did not meet standards of pharmaceutical quality required for an investigational drug. Cytotoxicity against human tumor cell lines and in vivo rodent xenograft tumor assays consistently failed to demonstrate a potential anticancer activity of syn-phospho. Preclinical safety studies of syn-phospho were also insufficient to support a trial of this investigational drug in cancer patients. Moreover, the ethical approval decision apparently overlooked two previous findings that suggested a possible enhancement of mammary carcinoma cell proliferation by phosphoethanolamine, and an apparent increase in lung metastases (rat implanted tumor assay) by syn-phospho. The syn-phospho risk-benefit ratio is clearly unfavorable and, thus, this trial in cancer patients does not fulfill a key requirement to make a clinical research ethical. There are also concerns regarding whether the study design is robust enough (scientific validity), and the social value of the trial of syn-phospho in cancer patients is questionable.
    MeSH term(s) Antineoplastic Agents/therapeutic use ; Brazil ; Clinical Trials as Topic/ethics ; Drug Evaluation, Preclinical/ethics ; Drugs, Investigational/therapeutic use ; Ethanolamines/therapeutic use ; Ethics Committees, Research ; Humans ; Risk Assessment ; Therapeutic Human Experimentation/ethics
    Chemical Substances Antineoplastic Agents ; Drugs, Investigational ; Ethanolamines ; phosphorylethanolamine (78A2BX7AEU)
    Language English
    Publishing date 2017-05
    Publishing country Brazil
    Document type Journal Article
    ZDB-ID 2027973-5
    ISSN 1806-9282 ; 0104-4230
    ISSN (online) 1806-9282
    ISSN 0104-4230
    DOI 10.1590/1806-9282.63.05.388
    Database MEDical Literature Analysis and Retrieval System OnLINE

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