Dr. Irving Kent Loh
I have been a clinical researcher for almost 50 years. After medical school and internal medicine residency, I was selected to go to the National Institutes of Health where I learned the basics of randomized double-blinded, placebo-controlled clinical trials, which became the gold standard for validating the superiority (or not) of a new intervention compared to the best standard therapy.
My earliest work was determining whether lowering cholesterol levels reduced the development of coronary artery disease. The validation of coronary artery calcification came out of that early trial and became a linchpin in early assessment of coronary heart disease. My more recent work has focused on development of pharmaceutical agents to modify cardiovascular risk factors that contribute to the progression of heart disease or its manifestations.
As we all know, recently approved pharmaceutical agents are almost always quite expensive, especially those developed for high impact critical diseases. Almost everyone frets about these expenses on general principles, but if the disease affects you or those you care about, it becomes very personal since the sometimes-exorbitant cost means compromise in other parts of one’s life since most of us live with finite resources. Either one does without the medication or self reduces the dose in order to try and get some benefit yet save money. But I can tell you that the FDA approved doses are those that have been proven to have the desired benefit and alterations in dosing, or not taking the medication at all, may not have the hoped-for benefit.
The reason for the high prices is complicated and vary from company to company. The ins and outs of that establishment of pricing is beyond the scope of this short column, but they fall into the categories of drug discovery, development, validation, and marketing. It costs about a billion dollars to bring a drug to market since there are a lot of failures and blind alleys encountered along the way that still need to be paid for in the budget. There are many scientists, labs, technicians, and regulatory issues to deal with, and sales and marketing teams need to be hired to get the pharmaceutical to intended patients who will benefit.
Compounding these issues is that the copyright to the drug is about 20 years and the clock starts when the company starts developing it, not when they start selling it. So all that development time works against the company in that the longer it takes to get a drug to market, the less time they have to sell it and make its profit.
This is why efficient clinical researchers and suitable patients willing to participate in these clinical trials are so important. If everything goes according to plan, a pharmaceutical company may have 7-12 years to sell its proprietary drug before the copyright expires and generic drug manufacturers can jump in and start making the cheaper versions of those branded name products.
There are tricks that a pharmaceutical company can use to extend its copyright timeline. It can find new indications for FDA approval, or it can tweak the formulation so that it’s “different,” or it can even pay the generic companies to hold off making the cheaper versions.
The reality for us, the consumer, is that generic drugs are often, but not always, less expensive than the branded medications. They may be as much as 85% less expensive and carry a much lower copay as well.
But generics often look different by shape, size, color. They may have a different texture and taste. Since there are many generic drug manufacturers making the same generic drug, each company’s version may be different that another’s, and certainly not like the “real” drug since exact duplication, would be a copyright violation. Every time you fill the prescription for the same drug, it may look different that the last one you had, even though the name and dose are the same. This also, incidentally, assumes that the pharmacy filled the prescription correctly.
This brings us to the point of this column. Do the generic drugs you are picking up really have the same benefits (and side effects) as the original branded agent? The active agent is the same, but there will be differences in the fillers that may alter the texture, color, and there may be differences in the medication’s shape. None of these ingredients should significantly alter the way the drug behaves in the body otherwise the FDA would not certify its “bioequivalence,” the sine qua non for being an approved generic agent suitable for sale here in the U.S. There is, however, a risk that there may be a different component, such as gelatin or a dye color, to which a patient may be sensitive that is not present in the…
Read More: Are they really the same?