Cited by 101Complementary and Alternative Medicine StudiesMedicinal Plant ResearchPhytochemistry Medicinal Plant Applications

The DOI matches its Crossref record.

New therapies from old medicines

Open access
Chen, Shaw T, Dou, Jinhui, Temple, Robert, Agarwal, Rajiv, Wu, Kuei-Meng, Walker, Susan·2008·Nature Biotechnology

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Crossref · 10.1038/nbt1008-1077

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  • IND submissions are often misused by opportunistic manufacturers to claim scientific credentials for already-marketed dietary supplements, exploiting laypersons' inability to distinguish between INDs and approved drugs.

    “IND submissions are often misused by opportunistic manufacturers to claim scientific credentials for already-marketed dietary supplements, exploiting laypersons' inability to distinguish between INDs and approved drugs.”

    From Indian Imaginaries of Chinese Success in the Global Herbal Medicine Market: A Critical Assessment (2019) · cites this paper as S. Chen et al. 2008, 1080

    In “From dietary supplements to new drugs” (p. 1077), the paper distinguishes dietary supplements from drugs; its discussion of IND submissions addresses regulatory review and prior human experience. The passages on supplement claims say those claims can be confusing, but do not say manufacturers misuse IND submissions to confer scientific credibility or that consumers confuse INDs with approved drugs. Searches for IND misuse, marketing of supplements, and promotion of IND status found no passage addressing that allegation. (LLM, conf=0.77)

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  • Trials are often terminated midway because unfavorable results could jeopardize their current market.

    “Trials are often terminated midway, because unfavorable results could jeopardize their current market.”

    From Indian Imaginaries of Chinese Success in the Global Herbal Medicine Market: A Critical Assessment (2019) · cites this paper as S. Chen et al. 2008, 1080

    The discussion of dietary supplements and clinical testing (p. 1077) says that reporting clinical testing to the FDA is not required for certain marketed products. It does not say that trials are often terminated midway to protect an existing market. Searches for premature trial termination, unfavorable results, and commercial concerns found no passage addressing that claim. (LLM, conf=0.73)

    Experimental — accuracy not yet measured

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Research works printed but not linked: 13

  1. Wu, K.M. et al. Toxicol. Lett. 111, 199–202 (2000). · DOI
  2. Wu, K.M. et al. Am. J. Ther. 11, 213–217 (2004). · DOI
  3. Murayama, M., Takao, M., Bando, H. & Amiya, T. J. Ethnopharmacol. 35, 159–164 (1991). · DOI
  4. Lindenmuth, G.F. & Lindenmuth, E.B. J. Altern. Complement. Med. 6, 327–334 (2000). · DOI
  5. Turner, R.B., Bauer, R., Woelkart, K., Hulsey, T.C. & Gangemi, J.D. N. Engl. J. Med. 353, 341–348 (2005). · DOI
  6. Hypericum Depression Trial Study Group. J. Am. Med. Assoc. 287, 1807–1814 (2002). · DOI
  7. Shelton, R.C. et al. J. Am. Med. Assoc. 285, 1978–1986 (2001). · DOI
  8. Kasper, S., Anghelescu, I.G., Szegedi, A., Dienel, A. & Kieser, M. BMC Med. 4, 14 (2006). · DOI
  9. Nakachi, K., Eguchi, H. & Imai, K. Ageing Res. Rev. 2, 1–10 (2003). · DOI
  10. Lin, Y.S., Tsai, Y.J., Tsay, J.S. & Lin, J.K. J. Agric. Food Chem. 51, 1864–1873 (2003). · DOI
  11. Jiang, X. New Medical College, Encyclopedia of Chinese Materia Medica (Zhong Yao Da Ci Dian) (Shanghai People's Press, Shanghai, China, 1977).
  12. Stevens, T., Qadri, A. & Zein, N.N. Ann. Intern. Med. 142, 477–478 (2005). · DOI
  13. Gloro, R. et al. Eur. J. Gastroenterol. Hepatol. 17, 1135–1137 (2005). · DOI

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Metadata

Authors
Chen, S. T., Dou, J., Temple, R., Agarwal, R., Wu, K.-M., & Walker, S.
Affiliations
United States Food and Drug Administration (US)
Venue
Nature Biotechnology
Published
2008-10
Volume
26
Issue
10
Pages
1077-1083
ISSN
  • 0733-222X (ISSN-L)
  • 1087-0156
  • 1546-1696
OpenAlex
W2061285450
Cited by
101
References
0
Citations by year
2025: 3 · 2024: 1 · 2023: 4 · 2022: 5 · 2021: 5 · 2020: 4 · 2019: 5 · 2018: 2 · 2017: 8 · 2016: 11 · 2015: 7 · 2014: 11 · 2013: 7 · 2012: 13
FWCI
13.93
Type
journal article
Language
en
Open access
Licence
Locations
  • Nature Biotechnology (publishedVersion)
  • PubMed (publishedVersion)
  • Zenodo (CERN European Organization for Nuclear Research) (submittedVersion, public-domain)
Topics
  • Health Sciences › Medicine › Complementary and alternative medicine › Complementary and Alternative Medicine Studies
  • Life Sciences › Agricultural and Biological Sciences › Plant Science › Medicinal Plant Research
  • Life Sciences › Agricultural and Biological Sciences › Plant Science › Phytochemistry Medicinal Plant Applications
Keywords
plant-derived drugs, herbal medicine, drug approval, FDA regulation, new drug development, prescription drugs
MeSH terms
Drug Industry, Phytotherapy, Plant Extracts, United States, United States Food and Drug Administration, Drug Approval

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