Part of my life as a nurse, involves educating patients on drugs that are ordered for them, why they are important and the side effect that may or may not occur. It is extremely important that we create understanding of medications for not only the simple fact that they may be life saving, but also, they may help improve overall health.
Once the patient leaves my care, they become the ones responsible for managing medications, monitoring their care and reporting things to their care provider that will ultimately impact their livelihood. If they don't, then more likely, they will end up back in the hospital as a readmission with new costs, possibly new medications and a slew of new knowledge to learn.
In May of 2019, Katherine Eban, an award-winning journalist wrote a book titled Bottle of Lies: The Inside Story of the Generic Drug Boom. The book covers a great history of the FDA, why it was originally created and what it does today, as well as how the generic drug industry really got its start in the U.S. via the Hatch-Waxman Act (Drug Price Competition and Patent Term Restoration Act of 1984). This act opened up an approval pathway for generic drug products to be approved by the FDA.
This investigative piece, outlines one of the biggest fraud's of the generic drug industry, how testing of samples by major pharmaceutical companies, as well as the data collected, were intentionally falsified and how these companies did not do due diligence with testing of the ingredients of some drugs.
Generic versus Brand Drugs
A generic drug is a version of a brand name drug that is made after a brand name drug has either gone off of it's patent OR the generic company has successfully challenged the brand patent in court.
Brand and Generic medicines will differ in their ingredients by tiny bits, but those bits are impactful enough to have disadvantages.
Generic drugs are reversed engineered (unless the brand company has partnered with the generic drug company to make it as similar as possible with the brand companies recipe).
Brand companies make it exceptionally hard for their recipe to be found due to multiple patents to be placed on a medication from as far down as the molecular process and as far up as the manufacturing process of the drug. Therefore, generic drug companies reverse engineer the drug as best as they can.
More information and Terms from the Generics and Biosimilars Initiative and what they mean as well as the World Health Organization Definition.
There are many reasons to why the generic drug market began to boom, as outlined in the book. Some of which include a moral decline and corruption by some members of the FDA by accepting payments to get drugs pushed to market; the FDA was forced to become a global agency with the inherent boom of the generic drug market in a very short amount of time. This does not mean that the FDA, in total, is bad.
What to consider within our drug market.
80% of all active ingredients in all of our drugs, whether brand or generic, come from overseas. LA Times.
90% of our drug supply is generic. Newsweek.
Almost none of the antibiotics are coming from the United States-it is probably coming from India or China. The Washington Post.
This makes the process of drug creation cheaper, but by no means, safer. Boston Globe.
It may cost upward of $1 Billion (and a median of $19 million) to develop a new drug, up to and past 10 years to study the drug and the price to make the drug is factored into the price of the drug once it becomes available to market. Link: Cost of Clinical Trials for New Drug FDA Approval Are Fraction of Total Tab.
The cost of drug making isn't necessarily delivering the best outcomes to patients. Harvard and Pew Charitable Trusts. An example comes from the drug Valsartan which had carcinogens in the drug for six years prior to the recall. This drug was coming in from China and India.
What Can You Do For Yourself and Why That Matters
If a drug has an expected outcome, as the consumer, you should pay attention to that outcome. Medications prescribed to you should do what is prescribed. So, if you are taking a medication for your cholesterol level, be mindful that it should work within a given time frame. If it isn't, ask questions.
Read Katherine Eban's A Guide To Investigating Your Own Drugs.
Have an open discussion with your pharmacists. Be mindful that your pharmacy may be partnered with a larger pharmaceutical company, and so, you may not be able to switch your manufacturer.
Valisure is a pharmacy whose business model exists by the sole means of testing every batch of drugs as they come in. They are the pharmacy that identified a carcinogen in a medication which the FDA missed. You can use them as your pharmacy, too.