Generic Lipitor - Not Yet. Other Excellent and Less Pricey Alternatives

On a recent radio ad for LIPITOR, Pfizer's best selling cholesterol lowering medication, the announcer states two interesting points.

• There is no generic LIPITOR.
• Your doctor may ask you to switch to a less pricey alternative, but if everything is working fine with LIPITOR, why would you switch?

Indeed, why would you switch?

For a full court press, at the LIPITOR website, they've dedicated an entire section on questions you should ask your doctor as well as other things you should consider.

Now I'm all in favor of empowering individuals with information, so the wise patient needs to be a wee bit skeptical when a pharmaceutical company appears to be providing "helpful" information that promotes their product.

Let's look at each point objectively.

• LIPITOR is the #1 prescribed branded medication in the world. -- True. Number one doesn't mean it is the best. Note that the recalled VIOXX anti-inflammatory and its related CELEBREX competitor were pulled of the shelves because of research that suggested increased heart attacks compared to other less pricey alternatives, NAPROSYN. CELEXBREX was the number one prescribed anti-inflammatory on the market at the time.

• LIPITOR is FDA-approved to significantly reduce the risk of: Heart attack, Stroke, Certain kinds of heart surgeries, Chest pain. -- True. Other cholesterol lowering medications are also approved for the same indications.

• LIPITOR is one of the most widely studied medicines in the world—with more than 15 years of research.-- True. Incidentially there are other cholesterol lowering medications that have been around for even longer.

• If you switch, you may not get the same cholesterol-lowering results you get with LIPITOR. LIPITOR is proven to lower LDL ("bad" cholesterol)- 76 to 115 points, or 39%-60% (average effect depending on dose). The cholesterol level you've achieved could change. -- True. This part is a little trickier. LIPITOR is one of the most potent cholesterol lowering medications in the family of medications called STATINS. The one that lowers the most at this time is called CRESTOR (and obviously it isn't generic either). But does lower LDL (bad) cholesterol mean better outcomes, that is less likelihood of heart attack and stroke? It depends. The cholesterol lowering medication VYTORIN, which contains two cholesterol lowering medication - ZOCOR and ZETIA, actually lowered LDL cholesterol better than ZOCOR alone, yet the study which looked at how much the carotid artery (neck artery) blockage decreased showed little to no change. So lower doesn't necessarily mean better, even though intuitively we want to believe it to be the case.

Indeed the four questions that Pfizer has you ask your doctor or pharmacist really hinge on the last point.

• No generic LIPITOR. This means, you will pay more until LIPITOR goes generic.
• Is generic ZOCOR proven to lower cholesterol as well as LIPITOR. No, ZOCOR, also known as SIMVASTATIN, isn't as potent. But don't get fooled, the real question is if I reach my LDL (bad) cholesterol goal with ZOCOR or LIPITOR, is one far better than the other in protecting my heart?
• If I switch could the cholesterol level I've achieved change? Yes it can. But better question, is it possible to achieve the same change with a different medication?
• If I switch could my body respond differently? Yes, but is it also possible that it might not?

Pfizer is doing what most pharmaceutical companies do when their product will soon lose its patent and become generic. They are trying to increase loyalty to their brand, even though LIPITOR is the dominant cholesterol lowering medication in the market.

Want reasonable alternatives and analysis that is objective? Consumer Reports has a free drug report which is fantastic. Here's what they say:

Taking the evidence for effectiveness, safety, and cost into account, we have chosen four statins as Consumer Reports Best Buy Drugs:

* Generic lovastatin and pravastatin — if you need to lower "bad" (LDL) cholesterol by less than 30%
* Generic simvastatin (20mg or 40 mg) — if you need 30% or greater LDL reduction and/or have heart disease or diabetes, or if you have had a heart attack or have acute coronary syndrome and your LDL level is not highly elevated.
* Atorvastatin (Lipitor) (40mg or 80mg) — if you have had a heart attack or have acute coronary syndrome and your LDL is highly elevated; use for two years and then reconfirm need or switch to generic simvastatin. Generic pravastatin and simvastatin became available in 2006. The price of these two medicines will decline in 2007, creating a significant savings opportunity compared to brand-name statins.

There you go. This is the nuance that is heart of a candid conversation between you and your doctor. Pfizer wants you to think the LIPITOR is the only cholesterol medication for you. Medicine is never quite that black and white. Smart patients will realize that there is always a deeper story and shouldn't get fooled by 30 second sound bites. Consumer Reports does say LIPITOR is a good choice for certain conditions. Note however they also say that generic SIMVASTATIN is also for patient who has had a heart attack or acute coronary syndrome, just like LIPITOR.

So why is Pfizer pushing now? Well if you check the FDA website on medications and when they lose their patent, LIPITOR 10 mg will no longer have protection in September 2009, this year!

So if it is too expensive to continue with LIPITOR, don't worry that you aren't getting the right care. Do some research by going to the Consumer Reports website. Ask more questions than the spoonfed ones by Pfizer. It is possible that you do need LIPITOR. It is also a very good chance you don't and others will do the job just fine at keeping you healthy and perhaps saving you money so you never have to choose between your health and all of the other important things you need to take care of.

What's the Best Medicine / Treatment? Doctors Don't Know

Fascinating article from the Associated Press titled, "What's the best medicine really?" in which a government panel will try to determine which therapies and medications are better than others in a study of "comparative effectiveness". Funded by the stimulus package passed by Congress, about $1.1 billion will be spent understanding this.

Naturally, all parties involved have a stake in this because there will be losers. Although the article states that it is a secret that newer medications don't need to be better than older proven therapies, that isn't true. It's that the public is unaware that for FDA approval, medications only need to be better than placebo.

Pharmaceutical companies rarely do comparative effectiveness studies because they can backfire. Note how Bristol-Myers Squibb compared its cholesterol lowering medication PRAVASTATIN (PRAVACHOL) against Pfizer's ATORVASTATIN (LIPITOR) in the PROVE-IT study. Bristol-Myers sought to prove that its medication was better than the newer one, LIPITOR. They were wrong and it cost them.

The real challenge isn't just understanding what works better than others. The real challenge is how to get this information to doctors consistently and in a timely manner. Research shows that on average it takes 17 years for medical research and findings to be practiced routinely in the community doctor offices. Whether the internet and information technology shortens this time frame remains to be seen. As a result, all the studies in the world are meaningless unless those at the front lines - doctors and patients get this information.

I am skeptical that any study will ultimately help manage healthcare costs.