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Question: Are brand name drugs better than generic drugs?

Answer: Companies invest billions of dollars and large amounts of time in developing pharmaceutical drugs. The process is very complex. In fact, each drug that is developed can take anywhere from 10 to 12 years and can cost around US$1.5 billion.

Making a drug starts with the disease. Scientists identify a particular disease and rigorously study it to understand everything they can about the disease process. Once they understand the disease, they identify a target pathway to attack it. For example, if bacteria have to cross from the bloodstream across the cell membrane to get inside the cell, the scientists might try to block the bacteria from crossing the cell membrane. Having identified that this pathway needs to be blocked, scientists now have to try to find a molecule that will block this pathway.

Steps to developing drug

Scientists typically cast their nets wide and may come up with as many as 10,000 options for molecules to block the pathway. They then test each molecule to see if it has the desired effect. Most of the molecules will be eliminated, leaving only about 10 to 20 options. Research continues to ensure that the molecules are effective and safe. Researchers use computerised models, cells, and animals to conduct these investigations.

About five to 10 molecules might make it through this testing process and become viable for testing in humans. The company then has to apply to regulatory authorities, such as the Food and Drug Administration (FDA), and provide evidence that this molecule will attack the disease process without having deleterious effects on humans. If the regulatory authority is satisfied, they will grant approval for clinical trials, where the drug is tested in humans.

Clinical trials take place in phases. Phase one clinical trials utilise a small number of healthy volunteers. Small doses of the drug are given to 20 to 100 healthy volunteers. These individuals are closely supervised during this process. About half of the molecules will not make it through this process for various reasons, and will be eliminated. Phase two clinical trials utilise 100 to 500 patients who actually have the condition the drug is intended to treat. The patients are given the drug in different doses and by various methods, such as orally or intravenously, to determine the best way to administer the drug. Some of the drugs will turn out to be ineffective or have intolerable side effects and safety issues, and will be eliminated.

The few molecules that make it to phase three clinical trials will be tested on 1,000 to 5,000 patients across different countries. The aim here is to confirm that the dose and method of administration are safe and effective among people of various races and ethnicities. Again, some drugs will fail at this stage.

If none of the molecules make it through phase three clinical trials, the drug company would have wasted 12 years and billions of dollars. If, however, a drug makes it through phase three, the developer can take it to market. When the drug goes to market, post-marketing surveillance is carried out to ensure the continued safety and efficacy of the drug.

Innovator company interest

A drug company that develops a drug patents the molecule. The patent prevents another drug company from copying the drug for 20 years. This patented drug becomes the brand name drug. Often, the brand name drug is quite expensive because the drug company has to recoup the monies spent in developing the drug, cover the development costs of the drugs that failed to make it to market, and gain monies to invest in the development of future drugs. After the patent period has expired, generic companies can manufacture and market the drug.

Generic versions of the drug are normally significantly cheaper because these companies do not have to invest time and money in research and development, as that would have already been done by the innovator company.

Brand or generic?

So, which is better — brand or generic? The generic versions might have slightly different formulations in terms of the excipients (extra things used to bulk up tablets, syrups, et cetera). However, they use the same molecule developed by the innovator company.

There are strict guidelines to make sure that generic versions are just as effective as the brand name products. Yes, there might be slight variations in how the generic is tolerated or absorbed because of the excipients, but the overall effect should be quite similar. If you do not particularly like one generic, you can try another or you can use the brand name drug to see which you like better. Once you choose a brand or generic, though, try to stick to it so the effect of the drug is consistent.

It is essentially a matter of personal choice and affordability whether you choose brand name or generic drugs. You will certainly get the effective dose of the medication either way.

Novia Jerry Stewart, MSc, RPh, is a pharmacist who specialises in ophthalmic care. She may be contacted at novia_jerry@yahoo.com.