Editor's Memo
by Forest A. Tennant, MD, DrPH
 Generics are, all of a
sudden, the “new rage.” Not only are they supposed to be cheaper and more
effective, they’re even being touted in some uninformed quarters as “the
answer” to high health care costs! One gets the eerie feeling that all this hype is
coming from the public relations firms hired by the generic firms to boost sales and stock
price.
What are the real facts? First, there’s no question that some drug lines such as
antibiotics, hypertensive agents, asthma preparations, topicals, and most injectables have
notable examples of generics that have equal equivalency at lower cost. Ask any physician;
he or she will give you a favorite.
Now, however, we are being confronted with generic opioids which are hitting the
market. Can they show equal muster to the name brands such as Duragesic«, Oxycontin«,
Kadian«, Avinza«, or Actiq«? Information is becoming available to begin to answer this
question. In the case of therapeutic opioids, it is not the basic chemical that is the
issue. Therapeutic opioids are compounds that are grown in nature, thanks to the opium
poppy, or synthesized in such a manner that they closely resemble the endogenous opioids
including Beta-endorphin, enkephalin, and dynorphin. However, to relieve pain, therapeutic
opioids must lock into mu, delta, and kappa receptors. The real challenge in providing
pain relief is to provide adequate tissue availability at the receptor site. This is the
rub and the reason why many anecdotal reports from patients, pharmacists, and physicians
suggest that many of the new generic opioids aren’t cutting it. Why? The formulation
of the complex delivery systems found in the trade-name therapeutic opioids are truly
superb. Many pharmaceutical companies have spent millions to develop and formulate
patches, lollipops, tablets, capsules, and liquids to insure proper gastrointestinal,
transmucosal, or transdermal delivery to produce absorption and opioid blood
concentrations that bring the opioid face-to-face with opioid receptors in the nervous
system and elsewhere to achieve good pain relief. Here’s where the generics may fail.
They have tried to cheaply copy these proprietary delivery systems, and they may simply
fail to deliver the opioid at rates and concentrations that interact optimally with opioid
receptors.
The shell on a generic pill, or the membrane on a generic patch, may look fine, but the
real McCoy took a long time and a lot of money to synthesize. A quick “me too”
generic may not deliver the same pain relief. Put another way, generics may work for strep
throat, but not severe, intractable pain.
Another myth may be cost. Generic opioids may be touted as being cheaper than trade
names but, in actuality, are only a few percentage points below the cost of the “real
stuff.” More cogent, however, is that generics may end up costing the patient and
health plans more, not less. The patient may have to take additional dosages to achieve
the same blood level pain relief as with a trade name opioid. Or the physician may have to
add additional drugs to the regimen to achieve equal pain relief. All told, physicians who
treat pain—and patients who endure it—are not embracing the new generic opioids
with much enthusiasm. While this statement is currently based on a growing number of
anecdotal reports, look for studies showing that generics don’t achieve the same
blood levels and absorption rates as the trade name opioids.
As usual we call for a careful ear to each patient’s report of effectiveness. But be
prepared to mark on the prescription, “Do not substitute.”
— Forest A. Tennant, MD, DrPH
Editor in Chief
— Jul/Aug 2005
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