15 July 2004

Translates To Better Profits For Drug Companies

While we were discussing the merits and demerits of a pull-out from Iraq by the Philippines, the US government last Monday (July 12) issued an update to the 2001 National Cholesterol Education Program (NCEP) guidelines. The NCEP is used by all American doctors in cholesterol management for their patients, and as Filipino doctors use the NCEP too, as reference, I believe we are equally affected.

The update is published in the latest issue of Circulation and the full report can be accessed here. The update is based on based on a review of 5 major clinical trials of statin therapy --- the PROSPER, HPS, ALLHAT-LLT, ASCOT-LLA, and PROVE IT-TIMI 22 studies, which all cardiologists are very familiar about. The statins or cholesterol-lowering medications in the study include atorvastatin (Lipitor by Pfizer), fluvastatin (Lescol by Novartis), pravastatin (Lipostat by Bristol-Myers Squibb), rosuvastatin (Crestor by AstraZeneca), and simvastatin (Zocor by Merck) are all available and sold here in the Philippines and in the US.

Highlights of the update include:
1. An LDL goal of below 100mg/dL for high-risk people and below 130mg/dL for moderately high-risk people. Since the new update found that LDL levels as low as 70 mg/dL --- 30 points lower than the 2001 guidelines --- reduced coronary disease in certain at-risk groups, the new guidelines advocate a 70mg/dL LDL goal for very high-risk patients whose LDL levels are already below 100 mg/dL.
2. The concept of using cholesterol-lowering drugs like statins without lifestyle changes is NOT correct.
3. If diet and exercise do not work or LDL numbers are too high (greater than 130mg/dL), doctors should consider higher statin doses and adding another cholesterol fighter, like nicotinic acid.
From ATP III handout

For the uninitiated, HDL is the "good cholesterol" and LDL is the "bad cholesterol." LDL is the body's major cholesterol carrier in the blood. Cholesterol does not dissolve in the blood, and excessive amounts can build up on artery walls and contribute to formation of plaque that can cause fatal clots that result in strokes and heart attacks.

From Newsday

While the idea that it is good to lower cholesterol is not new, what stands out in the new update is how far medical experts now believe LDL should drop for patients at the greatest risk for heart attacks or strokes.

Also, while I have nothing against lowering bad cholesterol in high-risk patients, I am also left with a conclusion that this means big and good business for the drug companies.

Statins are the top-selling medications in the world. More than 36 million people take them and they generate sales of more than $26 billion a year. [Forbes]

Click here to read the article

Although the authors of the new report have not calculated it yet, it is safe to expect that the update will further increase the number of patients taking statins and expect more than 40 million people to take them today and in the coming years. As to sales, you do the math. The new update advise that patients at the highest risk should receive even more aggressive treatment, which translates to higher, more expensive doses of these drugs. This figure will further double by millions of people because the new guidelines suggest treating diabetics and people who at one time would have been considered healthy.

Can you now hear Pfizer's and Merck's cash registers ringing with glee?

In the US, for example, healthcare costs are already rising by double digits, and Lipitor or Zocor can cost $100 or more a month for a 30-day supply, or more than $3 a pill, for people without health insurance, according to industry price guides. And for those with coverage, their co-pays can be as high as $30 to $40 a month, depending on their health plan. [Newsday]

In the Philippines, according to respected cardiologist Dr. Esperanza Icasas-Cabral, the perennial problem has been the high cost of statin therapy which often leads to poor compliance. This also explains why most Filipino doctors are not so aggressive using the statins to lower cholesterol as they get frustrated when patients can not follow the treatment program. [Manila Times]

If you think my post is riddled with bad news, brace yourself because there's more to be sad about when you read this.

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