Course:SPPH381B/TermProject/Tylenol -Alex Kitt/Support Infrastructure

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Pharmaceutical Drug Development

Pharmaceutical drug development is a long process that typically costs around $2.6 billion, with over half of this value coming from clinical research [1].

Discovery and Development [2]

The first step of drug development is to 'discover' new chemicals, for example by designing drugs that impact certain cellular processes or by testing drugs that may have an effect. Following this, the drugs are tested for efficacy, toxicology, absorbance rates, and best mode of dosage.

Pre-Clinical Research[3]

Pre-clinical research uses both in vitro (in test tubes) and in vivo (in animals) tests for further toxicology and functional studies. Since it is so expensive to produce a pharmaceutical drug, researchers evaluate the effectiveness in molecules here to determine whether or not to continue research.

Clinical Research[4]

If drugs are selected to be tested in clinical research, then they must be tested in four clinical phase studies:

  • Phase I: To test safety and dosage in humans, 20-100 people (either sick or healthy) are tested on for several months.
  • Phase II: To test efficacy and side effects, several hundred people (with the target disease) are tested on for up to two years.
  • Phase III: To further monitor efficacy and adverse events, 300 to 3,000 people (with the target disease) are tested on for up to 4 years.
  • Phase IV: Lastly, several thousand people with the disease are tested on to ensure that the drug is safe and effective.

FDA Review[5]

Before drugs can be sold, FDA needs to review safety updates, directions, and other pertinent information. Once they are approved, the FDA and developer work to produce a label for marketing.

FDA Post-Market Safety Monitoring[6]

Once the drug has been released onto the market, further studies and monitoring of adverse events takes place. Ethical development of advertisements is also part of this process.

Animal Testing Hazards

Animal testing is a part of the pre-clinical trials. It is estimated that between 80-800 animals are used for testing per drug produced, including mice, rats, dogs, and more [7]. Not only is this a highly controversial issue ethically, but also poses significant health risks to laboratory staff.

Physical

  • Bites, scratches, and kicks: larger animals may be able to physically harm laboratory workers when they feel threatened
  • Explosions: Some gaseous euthanizing agents may explode if heated too high.

Chemical [8]

  • Disinfectants and Sterilants: Many disinfectants used in the industry are hazardous. For example glutaraldehyde, a commonly used on, has many effects including "both acute and chronic symptoms, including throat and lung irritation, asthma and asthma-like symptoms, nose irritation, sneezing, wheezing, nosebleeds, burning eyes, rashes, staining of hands"
  • Corrosive Substances: Strong acids and bases, such as sulphuric acid, can cause chemical burns to skin and irritate the eyes and respiratory tract.
  • Euthanizing Agents: Many chemicals used for euthanasia, such as ether, are hazardous to people. Furthermore, they have been linked to addiction, neurological issues, miscarriages, congenital abnormalities, and more. For more information on euthanizing agents, see here.
  • Tissue Fixatives: These include formaldehyde and glutarhaldehyde. Formaldehyde is deemed "reasonably anticipated to be a human carcinogen," and has been given an OEL of 3ppm by OSHA due to this. Both formaldehyde and glutaraldehyde are also irritants, and may cause sensitization after only several weeks of exposure.

Furthermore, many of the drugs used in animal testing have unknown health effects.

Biological

  • Development of allergies: It is estimated that between 10-44% of laboratory workers who work with animals develop allergies [9]
  • Zoonotic diseases: Diseases that are transferred from animals to humans are called zoonoses, and can include bacteria, viruses, fungi, protozoans, worms, and anthropoids.[9]

Psychosocial

  • Emotional stress: Testing on, and eventually euthanizing, laboratory animals may cause significant emotional stress in people.

Ergonomic

Handling animals may be difficult as they move, and so may involve workers handling animals in awkward positions. Over time, these may induce strain.

References

  1. ↑ Mullin, R. Scientific American. (2014).Cost to Develop New Pharmaceutical Drug Now Exceeds $2.5B. Retrieved from: https://www.scientificamerican.com/article/cost-to-develop-new-pharmaceutical-drug-now-exceeds-2-5b/
  2. ↑ US Food and Drug Administration. (2015) Step 1: Discovery and Development. Retrieved from https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405382.htm
  3. ↑ US Food and Drug Administration. (2015) Step 2: Preclinical Research. Retrieved from https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405658.htm
  4. ↑ US Food and Drug Administration. (2015) Step 3: Clinical Research. Retrieved from https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm
  5. ↑ US Food and Drug Administration. (2015) Step 4: FDA Review. Retrieved from https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405570.htm
  6. ↑ US Food and Drug Administration. (2015) Step 5: FDA Post-Market Safety Monitoring. Retrieved from https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405579.htm
  7. ↑ The Baltimore Sun. (2010). Alternatives to animal testing gaining ground. Retrieved from http://articles.baltimoresun.com/2010-08-26/health/bs-hs-animal-testing-20100826_1_consumer-products-animal-testing-experiments
  8. ↑ Thomman, W. ILAR. (2003). Chemical Safety in Animal Care, Use, and Research. Retrieved from https://academic.oup.com/ilarjournal/article/44/1/13/650525/Chemical-Safety-in-Animal-Care-Use-and-Research
  9. ↑ 9.0 9.1 EHS. (2010). OCCUPATIONAL HEALTH AND SAFETY HAZARDS IN THE ANIMAL RESEARCH SETTING. https://ehs.ucsd.edu/animal/Animal_Research_Hazards10-26-2010.pdf
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