Chris Aiken, M.D.  Psychiatry & Psychotherapy

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New Medicines, Generic Medicines and Pharmaceutical Advertisements

About Pharmaceutical Advertisements

Since the late 1990’s, pharmaceutical companies have been allowed to advertise prescription drugs directly to consumers.  This has resulted in the now familiar slogan “Ask your doctor about…”

While this kind of marketing has increased awareness about psychiatric conditions, it has also lead to some misunderstandings. The advertisements suggest that their medicine is uniquely effective in a certain condition, such as Zoloft for social anxiety, or Lexapro for depression. They also give the impression that a break-through has been made or that newer medications offer more benefit than the older versions.

In reality, most conditions have many good treatment options and no one stands out as the best.  Why then are drugs advertised this way?  The answer is that the Food and Drug Administration (FDA) only allows companies to promote medications for the conditions they are approved for.  To get this approval, a drug must be safe and effective for the condition.  “Effective” does not mean better than other medicines; it means it worked better than a placebo, or sugar pill, in at least two clinical studies.

Many drugs meet the FDA’s basic requirement but have not been approved because the approval process is very expensive.  Once a drug is generic, there is little financial incentive to seek this approval or to advertise the medicine.  Also, some brand-name medicines are effective for many conditions, but are advertised for only one as a marketing strategy.

Are New Medicines Better Than Old Ones?

New medications sometimes represent a major breakthrough in treatment, but this is not always the case.  Some new medicines are simply variations on established ones.  For example, after the popularity of Prozac, other SSRIs were developed by making small changes in Prozac’s chemical structure.  Although these new SSRIs are just as good as the original ones, it is helpful to have several options because people will sometimes have a better response to one SSRI over others.

Other times what is new is not the medicine but the preparation.  Examples include timed-release versions of paxil, wellbutrin and stimulants.  These advances offer once-a-day dosing and sometimes have fewer side effects, but the medicine itself is unchanged. 

Another type of new medicine is comes from isolating part of the old medicine.  Most drugs contain two compounds that are mirror-images of each other – called the “right-handed” and “left-handed” sides.  Sometimes one side is more effective than the other, and a purified version of that side is released with a new name.  Examples include Lexapro, purified from Celexa, and Focalin, purified from Ritalin.  Usually these versions do not offer significant advances in treatment or side-effects.

Other “new” medications are actually not so new.  They may have been used in Europe for a long time before appearing in the U.S., such as Celexa and Clozaril.  Some may have been used for research purposes for many years before finally being released, such as Strattera and Ziprasodone.

A potential problem with new medications is that they may not be as well tested as older ones.  Although all medicines are studied carefully in large populations before being released, it is always possible that rare side effects are not picked up until the medicine is in wide-spread use. 

Are There Differences Between Generic and Brand-Name Medicines?

There is no reason to believe that generic products are not as good as brand-name products.

Generic drugs have the same chemical structure as brand-name versions.  There may be differences in how they are prepared by the manufacturer – in other words the type pill or capsule it’s in.  Since the chemical structure is the same, the question is whether generics pills disolve in the stomach and enter the blood stream the same way as their brand-name alternatives.  To be sold in the U.S., generic manufacturers have to prove that blood-levels for their drug are the same as for the brand-name version.  In proving this, the government allows a 10% difference, so that in reality generic drugs may cause blood levels that are 10% lower or higher than the brand-name versions.  This difference should be safe; it is similar to the kind of difference you might expect a brand-name drug to have depending on how your stomach is acting when you take it.

How Does a Drug Become Generic?

About 7-12 years after a medicine is released, its patent expires so that generic versions can become available.  Companies will sometimes develop new preparations such as the time-released Paxil CR, Wellbutrin XL and Effexor XR, and these new preparations have their own patents.  In these cases the generic will be available, but not as a time-released form.

Initially, generic compounds do not differ much in price, although you may notice a drop in your insurance copay.  The generic manufacturers start with a high price so they can recoup their investment in making the drug.  After a few years the price tends to fall dramatically due to competitive forces. Although generic medications are less expensive, they are usually not available as free samples or through patient-assistance programs for those with financial hardship. 

 

Updated 6/25/4 by Chris Aiken, M.D.