Generics and Therapeutic Substitution – Safety and Efficacy?

Excuse me for being a “doubting Thomas,” but when I saw articles in JAMA Internal Medicine and commentaries supporting use of generics instead of brand name drugs I asked myself “Where is the proof of equivalent results and safety?”.  Generic substitution implies that the original product is no longer patented and exclusive and another firm is now producing an identical chemical version which produces the same beneficial effects on the patient.  Therapeutic substitution means your pharmaceutical insurance company or pharmacy changes the drug you are prescribed to one in the same drug class. Think of drinking Coca Cola and having the supermarket substitute a comparable brand instead.

The reason for this is simply to spend less money. Many pharmaceutical insurance companies realize if they put an obstacle in your path of obtaining your medication you likely will pay for it independently saving them money.  The authors of the JAMA articles estimate between 2010 and 2012 therapeutic substitution would have saved $73 billion. The out-of-pocket savings to the patient would have amounted to $25 billion.

I’m for saving money and spending less with certain guidelines. However; I want to know that a generic medicine is produced in a factory inspected by the Food and Drug Administration (FDA) at least as frequently as the drugs produced in North American factories. I like to know where the drug was made including country of origin, city, location and the plant’s track record for health and safety. I also want to know the generic medication produces the same drug levels and positive effects as the brand name medication and is made with no more contaminants than the original branded product.

I need reassurance that my patient isn’t receiving a counterfeit product with stolen original labeling, which has been a scam fooling pharmacists and Customs agents for years.   I would additionally like to know that the generic product, or therapeutically substituted product, works as well as the original. We know for example that Levothyroxine generics and substitutions are problematic.  We additionally know that the beta blocker carvidilol (Coreg) has certain unique properties that other beta blockers do not provide making therapeutic substitution for less expensive medications in the beta blocker class problematic.

Once this information is available it should be distributed in package inserts, online and taught in pharmaceutical, nursing and medical school courses as well as CME courses for health care professionals.

There is an abnormally perverse concern that if a pharmaceutical representative takes a health care provider out for a meal and a drink while explaining their product, we will prescribe it even if it is more expensive or doesn’t work as well.  I doubt sincerely that most physicians would do that but do believe if the cost is comparable, or less, and the efficacy is as good, they might choose the product as a viable alternative.

Generic Drugs- Small Government and Less Regulation Lead to Lack of a Safety Net in Production

Years ago under pressure from consumer groups, Congress dramatically reduced the time a drug manufacturer could retain a patent on a brand drug.  The patent was reduced from 21 years from release of the product after FDA approval to 7 years from the time development begins. The extremely short window of opportunity to research and develop new medications led to extraordinarily high prices for the new medications. The law met its intended result of encouraging the rise of copy cat less expensive generic drugs.

At the same time under the Reagan Administration, the Food and Drug Administration closed its research and evaluation labs for testing new pharmaceutical products before they can be released to the American public. Under the new laws, pharmaceutical manufacturers now can contract with outside labs to test their products and the reports are then submitted to the FDA for review and approval.  No longer did a drug company have to submit its actual product to the FDA for their independent testing and approval or denial.

The results of these two pieces of government de-regulation was the rise of generic pharmaceutical manufacturing plants in remote regions of China , India and Asia with the most reliable and technologically advanced plants in Israel. Generics needed to prove to the FDA that they possessed 85% of the bioavailability of the brand product in reports generated by contracted labs and sent to the FDA for the products approval.

For years I suggested to my patients that if they could afford the brand name they were best served paying the higher price to obtain a product they knew was produced locally with relatively high standards.  The NY Times on Saturday August 13, 2011 ran a front page article noting that over 80% of generic products are produced in “shadowy” foreign factories that have never ever been inspected.  Several years ago 81 individuals perished because Chinese manufacturers substituted cheaper and tainted products in the making of the anti coagulant heparin. Counterfeit packaging and products originating with the Russian mob proliferate throughout the world market and are difficult for experts to distinguish from the real thing.

It appears that the Obama administration has finally reached an agreement with the generic drug industry for the industry to pay for government inspection of their facilities every few years. The legislation may pass through Congress this fall.

My suggestion to my patients remains the same. If you can afford the brand product purchase it. Know where your pills come from. Demand that your Congressional elected official works to fund the FDA so it can reopen its research and evaluation lab and be the independent agent determining the safety and efficacy of the drugs we are prescribed. Consider extending the length of a patent on new products in exchange for lower pricing on brand name drugs. It’s time to stop allowing only market forces to be watching out for the safety of our medications. That’s like asking the fox to watch the hen house.