DSI Newsletter: Generic Statins: Low Cost, Bad Medicine

DSI Newsletters, Issue 66:
Generic Statins: Low Cost, Bad Medicine

Generic Lovastatin (Mevacor) has been here since 2001 and generic Simvastatin (Zocor) is coming June 2006 and generic Pravachol (pravastatin) is not far behind. Lay people (patients) look forward to a drop in the cost of their cholesterol lowering medication. But is a generic Statin really cost effective?
This low cost cholesterol lowering drug maybe bad medicine. Statin drugs have long been used as a fast and effective way to reduce cholesterol, prevent heart attacks, strokes and save lives. The medical literature is full of studies describing by the numbers how people who take them benefit by living longer with fewer serious health risks. Some pharmacists and physicians see the class of statin drugs as pretty much interchangeable. The way statins are prescribed to reduce cholesterol may soon change when as early as June 2006 a generic version of the statin drug Zocor could hit the market. That is when Merck loses its patent protection against the manufacturer of a generic version of Zocor (Simvastatin); such a step could affect the sales of all interchangeable statin drugs. But will the patient suffer from this attempt to cut the cost of drugs?
Statin drugs such as Lipitor, Crestor, Pravachol, Lescol and Zocor will be at risk to lose sales once a cheaper way to reduce cholesterol comes on the market; although generic Mevacor has been around since 2001 and the branded statins have been doing just fine. Insurance companies may push for patients with high cholesterol, who will probably need to take the drugs for the rest of their lives, to go for a less expensive option.
Many in medical research argue that the generic Zocor and Mevacor are not as good as the brand name statins. They cite added research; better controls during the manufacturing process; and smoother blood levels as some of the reasons why it’s worth the extra price to get the brand name drug. To better understand why it is important to purchase brand name statins, one has to understand the product and the package theory. On the one hand, when you buy brand name Zocor you can easily see that it also says Simvastatin on the label. When the generic version is manufactured by the scores of competing generic companies, you will also see the name, Simvastatin. To the uninformed, it would be easy to say, "It is the same drug since they both contain the same chemical entity, Simvastatin." And it is true that it is the same chemical compound, but is it truly the same drug?
The quick answer is generic Simvastatin is not Zocor; it's really not the same drug. They are the same chemical substance, but the capsule (tablet, cover, vehicle, carrying case) is a cheap inferior substitute that can markedly change how the Simvastatin works! That is, it may not be as effective at lowering your cholesterol and it may be more apt to cause side effects.
This may sound like semantics, but there is much more to a Pharmaceutical Drug than the chemical entity it contains; the package counts (By package I mean the capsule or the tablet that is coated and covering the chemical that governs how it is released in your system). For example, just think about the eggs you are bringing home from the grocery. They come in a nice egg holder that allows you to reliably bring home the eggs from the market and usually they all survive the trip home. On a trip to Mexico, I noticed when you purchase eggs there, it is their custom to place the eggs in a baggy. I thought this was funny as I thought of the saying about not putting all your eggs in one basket. By the time the eggs arrived home, a percentage of them had broken and were no longer usable. I thought about bringing egg crates from home on my next visit to recycle them there.
With the coming threat of generic statins, I could not help thinking about these broken eggs. One could look at the eggs in the crates as the brand name eggs. They cost more to purchase initially, but more of them survive the trip home. But they are all eggs; aren't they? Why should we pay more just to have a better package to carry the eggs in? But there turns out to be other differences between brand name and generic eggs. The more expensive brand name eggs have better quality and safety controls associated with them than their generic equivalents in the bag. The brand ones come from chickens that are raised in accordance to stricter safety codes. The eggs are cleaned prior to placing them in the carton. Now you might say you can clean you own eggs. But it gets harder to remove material from the egg shell after it has had time to stick on the shell. So, when you crack open the eggs, impurities like salmonella are more likely to contaminate your breakfast and make you sick. But the generic eggs are cheaper, or are they.
Now the majority of people buying the generic eggs get by without problems. They make a special trip to the market and carry their eggs home especially carefully. They wash the eggs as soon as they get home. The few people that get sick and die in Mexico from these eggs are never heard from. In America there would be a bill board on every corner from an attorney advertising if you ate a generic egg and think you might have got sick, give us a call at 1-800-BAD-EGGS or visit our website: www.BadEggs.com and see how you can risk free get all the money you deserve and are entitled to for being injured by the evil egg suppliers that allowed you access to cheap inferior eggs that have dirty shells and are packaged poorly so that they break on transport.
Even though the pill says Simvastatin on it, the packaging does count. There is no miracle way generic companies charge less for their products. It is not just royalties that drive up the price of brand name drugs. They are truly a better product. When you consume Zocor (Simvastatin) you get a smooth, stable blood level over time. That is, over the 24 hour period after swallowing the pill, the Simvastatin level rises and falls. How it changes is crucial to how it works and how safe it is. Classically the generic equivalents have a "cheaper package" just like the generic eggs in Mexico. This allows the Simvastatin to reach a higher peak level which places you at risk for statin induced side effects like hepatitis and muscle injury. Then, the generic doesn't last the full 24 hours. When the level is lowest, it fails to protect you from a heart attack and stroke like the branded equivalent.
In conclusion, what might be cheaper to acquire in the short run may wind up much more costly in the long run. Remember, today's branded pharmaceutical fund tomorrow's wonder drugs. Be careful not to place all your eggs in one generic basket!

Sincerely:
Joseph Saponaro, MD, DABIM, FACP, CPI, CCI, CCTI, CCRC, CCRP
PI (Principal Investigator), DSI (Drug Study Institute)
Board Certified Internist, JPMC (Jupiter Preventive Medicine Center)
DABIM (Diplomat American Board of Internal Medicine)
FACP (Fellow American College of Physicians)
CPI (Certified Physician Investigator) by the AAPP (American Academy of Pharmaceutical Physicians)
CCTI (Certified Clinical Trial Investigator) by the ACRP (Association of Clinical Research Professionals)
CCI (Certified Clinical Investigator) by the DIA (Drug Information Association)
CCRC (Certified Clinical Research Coordinator) by the ACRP (Association of Clinical Research Professionals)
CCRP (Certified Clinical Research Professional) by SoCRA (Society of Clinical Research Associates)
Member, SIMPD (Society for Innovative Medical Practice Design)
Member, ACPM (American College Preventive Medicine)
Ethics Committee Member, Jupiter Medical Center
IRB Member, Jupiter Medical Center
Founder, CertifiedResearchers.com

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