Health
Will people give cholesterol drug Vytorin a second chance?
By Martha Rosenberg
Online Journal Contributing Writer


Aug 21, 2009, 00:17

For a trip down memory lane, visit Organizedwisdom.com.

You�ll be told that despite osteoarthritis, Olympic gold medalist Dorothy Hamill skates �five days a week for up to three hours,� thanks to Vioxx -- and can even �continue touring with the show Champions on Ice!�

�Take Vioxx exactly as directed by your doctor,� adds the site and �It was withdrawn from the U.S. market in 2004.�

For another health redux visit modelinia.com where you�ll be told super model Lauren Hutton was �the first television advocate for hormone replacement therapy, the postmenopausal preventive treatment for osteoporosis, heart disease, colon cancer, and Alzheimer�s.�

It�s a good thing for pharma that Americans have short memories and forget things like Vioxx quadrupling heart attacks and hormone therapy increasing them by 23 percent.

And, speaking of forgetting, that hormone therapy increases cognitive decline in women and shrinks brains.

How else would Merck and Schering-Plough have the audacity to bring back the �two sources of cholesterol� campaign less than two years after their Vytorin marketing drew lawsuits from state attorneys general and a congressional intervention?

And even as Merck and Schering-Plough, now in the process of merging, agree this month to pay $41.5 million to settle lawsuits with consumers and health plans who accused them of burying Vytorin�s clinical trials?

After agreeing last month to pay $5.4 million to 35 US states and the District of Columbia to reimburse investigations into Vytorin related �violations of consumer-protection laws�?

Heavily advertised until 2008, Vytorin was supposed to solve both your food and family �sources of cholesterol.� Ads saturated the airwaves, pun intended, with a split photograph of eggs, ham and other cholesterol-dripping foods and an older person who can eat them now thanks to, taa-taa, Vytorin.

Except that the glutton-out-and-pay-no-price promise wasn�t true.

Results of the 750 patient Enhance study found Vytorin had no effect on the buildup of plaque in the arteries, which is believed to correlate with heart attack and stroke.

Consumers, health plans, attorneys general and lawmakers were furious. Sen. Chuck Grassley (R-Iowa) asked the General Accounting Office to investigate why the FDA would approve a drug to reduce artery-clogging plaque that doesn�t reduce artery-clogging plaque.

Congressmen Bart Stupak (D-MI) and John Dingell (D-MI) wanted to know why Schering-Plough Executive VP Carrie Smith Cox unloaded $28 million of stock between the end of the study and release of its results, earning her the moniker the Martha Stewart of pharma. Schering-Plough had just paid $31 million to Missouri for bilking Medicaid with a different drug months earlier. Hello?

It wasn�t so much that Vytorin was no better than the generic simvastatin -- which cost pennies -- in reducing plaque and therefore heisted private and public health insurance dollars.

It wasn�t that patients and doctors thought they were buying health protection when they weren�t.

The reason for the outrage was the fact that Merck and Schering-Plough sat on the damning Enhance study for two years while the money rolled in struggling, so they said, to �analyze� the data.

Which part of the word lemon didn�t they understand?

Even drug salespeople on Cafepharma were buzzing about what a bust the study was.

Needless to say sales of Vytorin tanked after the clinical belly-flop. Especially because only months later a new, second Vytorin study which tested effectiveness in aortic stenosis showed Vytorin increased the chances of getting and dying from cancer.
Oops.

When the study results were integrated with two others trials, Vytorin only increased the risk of dying of cancer not getting it -- whew! -- and the FDA sounded an all-clear.

But the New England Journal of Medicine said a cancer risk could not be discounted in a Sept. 2008 editorial.

Now the Vytorin campaign is back like nothing happened -- thank you, regulators -- though Merck and Schering-Plough have agreed to adhere to new guidelines in their �direct-to-consumer TV ads� and clinical trials.

Both kinds of deception.