FacebookTwitterGoogle+RedditEmail

Merck is a Repeat Offender

by MARTHA ROSENBERG

Even as Merck seeks closure on its Vioxx nightmare by paying $4.85 billion to tens of thousands of plaintiffs who took the painkiller–not that it did anything wrong–the bad ink continues.

Articles about Vioxx, withdrawn from the market in 2004 for doubling stroke and heart attack risk, in the April 16, 2008 JAMA charge Merck disguised mortality data it submitted from Vioxx trials to the FDA and wrote the scientific papers itself it claimed were penned by doctors.

Merck transposed its own clinical study results of 34 deaths in the Vioxx group and 12 in the placebo group to 29 deaths in the Vioxx group and 17 in the placebo group when it submitted data to the FDA write Bruce Psaty, MD, PhD; and Richard Kronmal, PhD, professors at the University of Washington in JAMA. Worse, Merck knew as early as 2001 that participants in Vioxx trials who had Alzheimer’s disease were dying at three times the rate of those taking placebo.

Articles extolling Vioxx as the Super Aspirin were also a product of Merck machinations says another article in JAMA. They were actually ghostwritten from Merck’s own research with doctors’ “guest author” names attached as an afterthought write Joseph S. Ross, MD, MHS, Kevin P. Hill, MD, MHS and two other authors on the basis of 250 court documents they examined.

Merck marketing, with Schering-Plough, of Vytorin, the cholesterol drug exposed as no more effective than generics in January, is also under scrutiny in a House Energy and Commerce Committee investigation.

In fact it was the investigation, begun in December 2007, that pried loose the results of the Enhance study which Merck and Schering-Plough were sitting on since April 2006– despite clearance by consultant Michiel Bots–while they tried to change end points apparently to spin the data and unloaded Schering-Plough stock, say published reports.

“I would like for the companies to explain why they didn’t proceed with data analysis after Dr. Bots’ independent consultation report indicated the data were ‘fine,'” Rep. John Dingell (D-Mich.), chairman of the committee, said to The Star-Ledger.

In May, a House Energy and Commerce subcommittee hearing into deceptive drug industry marketing also looked at Merck’s multimillion dollar “cholesterol from two sources: food and family” Vytorin campaign in light of the suppressed Enhance study results.

“Many consumers may not have taken Vytorin had they been aware of the study results,” said Rep. Bart Stupak (D-Mich.) to Deepak Khanna, senior vice president of the Merck and Schering-Plough joint venture, according to The Star-Ledger.

Nor are other Merck drugs doing well.

Fosamax, Merck’s osteoporosis drug, was already facing more than 100 suits for causing osteonecrosis of the jaw or jaw bone death–added to its warning label in 2005–when a new wrinkle emerged. Women who took Fosamax were twice as likely to have atrial fibrillation, a chronically irregular heartbeat, as those who didn’t says an article in the April 28, 2008 Archives of Internal Medicine, echoing a New England Journal of Medicine article last year.

And Singulair, Merck’s allergy and asthma pill is under FDA review for possible suicide side effects.

But even as jokes appear about the number of Merck staffers required to change a light bulb–10 to call it a breakthrough, 10 to conference call Wall Street, 10 to suppress evidence it’s been done before and more safely and one to change the bulb–Merck is repeating its mistakes.

In April, it tried to launch a new cholesterol drug, Cordaptive, that combines niacin, a B vitamin which raises HDL but causes facial flushing with laropiprant, an anti-flushing drug, without waiting for study results, like it did with Vytorin.

Not only did the company want to start making money before safety was established in a 20,000 patient study that ends in 2012, Merck admits there are “theoretical” safety concerns about laropiprant’s effect on the liver, according to The Star-Ledger.

Plus, the science behind Cordaptive–that raising HDL, or good cholesterol will result in fewer heart attacks and strokes–is no longer reliable, says The Star-Ledger’s George E. Jordan.

“The utility of biomarkers was turned on its ear in a study of GlaxoSmithKlein’s diabetes pill Avandia, which found it lowered blood sugar in patients but resulted in elevated heart risks,” he writes. “Vytorin dramatically reduced LDL, but it worked no better at clearing clogged arteries than a generic drug five times less expensive.”

No wonder the FDA rejected Cordaptive out of hand, causing Merck to cut 1,200 sales jobs and add to its anti-fan club.

Merck didn’t even do simple market research. Vitamin and drug stores have been selling flush free niacin for years. A bottle costs about $9.95.

MARTHA ROSENBERG is staff cartoonist on the Evanston Roundtable. She can be reached at mrosenberg@evmark.org

Your Ad Here

 

 

 

 

 

More articles by:

Martha Rosenberg is an investigative health reporter. She is the author of  Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health (Prometheus).

Weekend Edition
February 16, 2018
Friday - Sunday
Jeffrey St. Clair
American Carnage
Paul Street
Michael Wolff, Class Rule, and the Madness of King Don
Andrew Levine
Had Hillary Won: What Now?
David Rosen
Donald Trump’s Pathetic Sex Life
Susan Roberts
Are Modern Cities Sustainable?
Joyce Nelson
Canada vs. Venezuela: Have the Koch Brothers Captured Canada’s Left?
Geoff Dutton
America Loves Islamic Terrorists (Abroad): ISIS as Proxy US Mercenaries
Mike Whitney
The Obnoxious Pence Shows Why Korea Must End US Occupation
Joseph Natoli
In the Post-Truth Classroom
John Eskow
One More Slaughter, One More Piece of Evidence: Racism is a Terminal Mental Disease
John W. Whitehead
War Spending Will Bankrupt America
Dave Lindorff
Trump’s Latest Insulting Proposal: Converting SNAP into a Canned Goods Distribution Program
Robert Fantina
Guns, Violence and the United States
Robert Hunziker
Global Warming Zaps Oxygen
John Laforge
$1.74 Trillion for H-bomb Profiteers and “Fake” Cleanups
CJ Hopkins
The War on Dissent: the Specter of Divisiveness
Peter A. Coclanis
Chipotle Bell
Anders Sandström – Joona-Hermanni Mäkinen
Ways Forward for the Left
Wilfred Burchett
Vietnam Will Win: Winning Hearts and Minds
Tommy Raskin
Syrian Quicksand
Martha Rosenberg
Big Pharma Still Tries to Push Dangerous Drug Class
Jill Richardson
The Attorney General Thinks Aspirin Helps Severe Pain – He’s Wrong
Mike Miller
Herb March: a Legend Deserved
Ann Garrison
If the Democrats Were Decent
Renee Parsons
The Times, They are a-Changing
Howard Gregory
The Democrats Must Campaign to End Trickle-Down Economics
Sean Keller
Agriculture and Autonomy in the Middle East
Ron Jacobs
Re-Visiting Gonzo
Eileen Appelbaum
Rapid Job Growth, More Education Fail to Translate into Higher Wages for Health Care Workers
Ralph Nader
Shernoff, Bidart, and Echeverria—Wide-Ranging Lawyers for the People
Chris Zinda
The Meaning of Virginia Park
Robert Koehler
War and Poverty: A Compromise with Hell
Mike Bader – Mike Garrity
Senator Tester Must Stop Playing Politics With Public Lands
Kenneth Culton
No Time for Olympic Inspired Nationalism
Graham Peebles
Ethiopia: Final Days of the Regime
Irene Tung – Teófilo Reyes
Tips are for Servers Not CEOs
Randy Shields
Yahoomans in Paradise – This is L.A. to Me
Thomas Knapp
No Huawei! US Spy Chiefs Reverse Course on Phone Spying
Mel Gurtov
Was There Really a Breakthrough in US-North Korea Relations?
David Swanson
Witness Out of Palestine
Binoy Kampmark
George Brandis, the Rule of Law and Populism
Dean Baker
The Washington Post’s Long-Running Attack on Unions
Andrew Stewart
Providence Public School Teachers Fight Back at City Hall
Stephen Cooper
Majestic Meditations with Jesse Royal: the Interview
David Yearsley
Olympic Music
FacebookTwitterGoogle+RedditEmail