What is a therapeutic good?
A therapeutic good is anything that is used for a therapeutic use, such as treatment, prevention or diagnosis of diseases, testing susceptibility to diseases, contraception and pregnancy tests. Even stuff like band-aids and thermometers are considered to be therapeutic goods.
Sometimes things can get a bit complicated. Let's start with foods. If you have a clove of garlic, that is food. If you concentrate part of the garlic, put it into capsule form and make a therapeutic claim (e.g. "can relieve cold and flu symptoms"), you now have a therapeutic good. Cosmetics can also be a bit confusing: moisturisers are normally cosmetics, but if they contain a sunscreen agent and claim to protect from UV radiation, they become classified as a therapeutic good. In short: the principal use and presentation of a product are important in determining whether something should be classified as a "therapeutic good" or not.
To make things even more confusing, there are some products that you would think should be therapeutic goods, but aren't. Hair products, such as bleaches and dyes, as well as some dental products, such as whiteners, are excluded from being classified as therapeutic goods. Breath testers used by police are also exempt, as is reproductive tissue for use in assisted reproductive therapy. Fresh, viable organs are exempt, though an organ that has been stored for a while is classified as a therapeutic good.
Why is regulation of therapeutic goods important?
It is important to regulate therapeutic goods so that we can (hopefully) prevent dodgy drugs from making it to market, or we can at least recall them quickly if they turn out to be problematic. Here are some examples of therapeutic goods that turned out to be problematic:
- Thalidomide- Perhaps the most well-known example. Thalidomide was originally created to treat morning sickness. However, it also caused babies to be born without limbs (or with deformed limbs), due to anti-angiogenic effects. Interestingly, thalidomide is sometimes used as an anti-cancer drug because of its anti-angiogenic effects.
- Vioxx- Originally created to treat rheumatoid arthritis and other forms of chronic inflammation, Vioxx was withdrawn when it was found to increase the risk of cardiovascular disease.
- Porcine small intestine submucosa (SIS)- SIS was advertised as an acellular scaffold for cell therapies. However, it was found to contain porcine DNA, resulting in inflammatory responses.
- Metal-on-metal hip implants- Metal-on-metal implants were found to release small metal particles into the bloodstream.
- Poly implant prosthesis (PIP) breast implants- These breast implants had the risk of exploding.
Regulation of therapeutic goods
To be honest, I mainly just zoned out here. Main points are that the main regulator in Australia is the Therapeutic Goods Administration (TGA). Their main concerns are quality, safety, efficacy and cost. All of these factors are taken into consideration when evaluating a new therapeutic good and when monitoring an existing good.
There are three main categories of therapeutic goods: medicines, medical devices and biologicals. Medicines include prescription and over-the-counter drugs, vaccines, blood and blood components, and animal cell and tissue-derived products. Medical devices include blood pressure monitors, cardiac pacemakers, surgical gloves, breast implants, condoms and human tissues used in diagnostics. Biologicals are things that are made from human cells and/or human tissues (aside from human tissues used in diagnostics).
And that's the last post for the semester! Good luck in exams!!
