LIPITOR: Pfizer Aims to Sell OTC Version

LIPITOR: Pfizer Aims to Sell Over-the-Counter (OTC) Version

After the collapse of sales, Pfizer wants to get a billion dollars with the help of patients.
In 2006, Pfizer sold its 13 billion statin, with a pervasive marketing.
This is one of the world's finest financial success and a disaster for the poor patients who took this toxic molecule.

PFIZER therefore wishes that this medication be over OTC (Over The Counter), as if it was a simple cough syrup.
People are unaware that it is a powerful drug, toxic, with many side effects. It is a drug that interacts with many others, by means of the cytochrome P450.

It is a drug that can cause terrible birth defects in fetuses. If ever a woman who is pregnant without knowing it (it happens for the 1st month), she may submit her baby to a dangerous product that affects the nervous system.

Historically, the FDA has approved the conversion of a number of prescription drugs to OTC status. For example, anti-ulcer/heartburn drugs such as the histamine H2 antagonist, Zantac, and the proton pump inhibitor, Prilosec – drugs first marketed more than 25 years ago – are readily available OTC. The same can be said for anti-allergy medications such as Claritin and Zyrtec. In general, these prescription-to-OTC switches are for drugs that have been used extensively, have a well understood side-effect profile, and are deemed by the FDA as being relatively safe.

Pfizer believes that Lipitor fits these criteria and is willing to run yet another clinical study to support this belief. Pfizer has started a 1,200 patient trial to determine if consumers taking OTC Lipitor will get their own blood tests at the pharmacy to see if the drug is improving their cholesterol profile. The trial will then measure if patients make the right health decisions based on their results. Most of the OTC drugs, such as pain relievers, heartburn drugs and anti-allergy agents, all relieve symptoms quickly and patients know whether the drug is helping them. High LDL-cholesterol, while harmful in the long term, is symptomless, and the FDA doesn’t want patients taking a drug that isn’t providing benefit – thus the need for periodic blood testing for cholesterol levels. Will patients be motivated to get their blood tested? That’s a goal of Pfizer’s study.

There’s no guarantee that, even if the Pfizer study is successful, the FDA will allow the OTC switch. Previously, Merck tried to get FDA approval to make its statin, Mevacor, available OTC, but this was rejected. However, Lipitor has been far more extensively studied than Mevacor. Furthermore, Pfizer is seeking OTC approval only for the lowest prescribed dose, 10 mg. Prescriptions doses can be as high as 80 mg. The FDA might be comfortable with this strategy.

Certainly, Pfizer stands to gain should the FDA approve OTC Lipitor. Goldman Sachs estimates that it could bring in $1 billion in sales each year. But generic companies also will benefit. Pfizer will get three years of exclusivity for OTC Lipitor based on the provisions of the Waxman-Hatch Act, provided that the FDA agrees that the clinical trial run by Pfizer met FDA guidelines. But after this time, generic companies are free to market their own OTC versions which would have to be called by Lipitor’s generic name, atorvastatin. Thus, they would be winners in this scenario as well as their patient pool would also be expanded.

However, insurance companies will also be big winners, as medical insurance doesn’t cover OTC medications. Insurers will no longer need to pay for 10 mg Lipitor prescriptions and, eventually, 10 mg generic atorvastatin prescriptions as well. Furthermore, in all likelihood, insurers will lobby hard to convert as many statin users as possible to OTC Lipitor. In doing so, they will perhaps shift as much as $1 billion of costs that they now have onto consumers.


But there will be no gain for the people : because this drug is not effective in primary prevention.

 

http://www.forbes.com/sites/johnlamattina/2014/03/04/who-stands-to-gain-with-fda-approval-of-otc-lipitor/