Bone Drugs - How to Build a Drug Empire

So...you want to run an international drug empire? In that case you're going to have to play the system like a virtuoso.

For a master class in system manipulation, you couldn't do much better than the big brains at Merck. Here's how they turned a completely made up bone-health condition into a license to print money.

In four easy steps...

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Friends in high places
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STEP ONE: Change the system to fit the drug.

In 1995, the FDA approved Fosamax--Merck's osteoporosis drug. But this "breakthrough" drug wasn't a blockbuster at first because there was a little diagnostic problem.

At the time, the only method to measure bone density in the spine and hips (the critical osteoporosis points) required cumbersome and expensive equipment. This made screening costly, so women weren't getting screened in large numbers.

Another technique used "peripheral machines" to measure bone density in a finger or a wrist. These machines were smaller and less expensive. But measurements of peripheral bones don't reveal what's going on in the spine and hips.

That critical detail didn't bother Merck officials. They launched a campaign to widely promote the use of peripheral machines in doctors' offices. This gave a boost to the number of people screened, a huge boost to the number of diagnosed osteoporosis cases, and an equally huge boost to Fosamax sales.

STEP TWO: Get some help from friends in Congress.

Want to REALLY improve your business? Throw a ton of money at Congress.

Intensive lobbying efforts by Merck paid off in 1997 with the Bone Mass Measurement Act. Under this act, bone scans were covered by Medicare. So Merck got another triple boost: more screenings, more osteoporosis cases, more Fosamax sales.

STEP THREE: Get some help from friends at the FDA.

1997 was a big year for Merck. In addition to purchasing the Medicare boost from Congress, they developed a low-dose Fosamax pill and got the FDA to approve this "new" pill as a treatment for a condition that requires no treatment at all.

They call the condition osteopenia--a word dreamed up by World Health Organization researchers to define diminished bone density.

But here's the catch: Just about everyone experiences bone density loss as a natural part of aging. So you may have perfectly healthy bones, but just not quite as dense at 45 as they were at 35. That's osteopenia.

Of course, the medical community knows that osteopenia isn't a serious health concern. But doctors played right along with Merck and the FDA. So now, Fosamax and other osteoporosis drugs are regularly prescribed for osteopenia.

STEP FOUR: Get more help from those FDA buddies.

Last year, FDA officials announced that they could find no evidence that bisphosphonate drugs, such as Fosamax, Boniva, Reclast, etc., increase risk of femur fractures just below the hip joint.

But that same month, two studies showed that long-term use of this class of drugs absolutely does appear to increase fracture risk.

Is this a disaster in the making for Merck? Not quite. After a brilliant marketing run of well over a decade, Merck's luck held out beyond the date when the patent for Fosamax expired in 2008.

Merck wins. Patients lose.

Except those, like us, who realize that marketing campaigns aren't medicine.

Tell your friends to just say no to drug therapy for osteopenia or osteoporosis.