FacebookTwitterRedditEmail

The Inconvenient Senator Grassley

The “bully tactics” and “intimidation” of drug industry operatives could cause “thousands of additional cancer deaths,” cries an angry doctor in a May 29 oped in the Wall Street Journal.

But Mark O. Thornton, MD, MPH, PhD, is not talking about the lobbyists and reps embedded in doctors’ and lawmakers’ offices even as patients and constituents wait for access.

He’s talking about Sen. Charles Grassley (R., Iowa), ranking member of the Senate Finance Committee.

You see, even though “Mr. Grassley did some good after the Vioxx episode, by focusing on the woeful manner in which postmarketing drug safety is managed and regulated by the FDA,” writes Thornton, who the Journal identifies as a former medical officer in the Office of Oncology Products at the FDA who “volunteers as president of the Sarcoma Foundation of America,” the Senator “and his staff should have kept their eyes on the ball.”

Instead, Grassley wants the Government Accountability Office to investigate why the cancer drug Avastin was approved for use in metastatic breast cancer two months after the FDA’s Oncologic Drugs Advisory Committee (ODAC) rejected approval–and on the basis of data that showed improvement in PFS–progression free survival, the period of time a patient doesn’t get worse–but no improvement in overall survival.

Even drug reps were surprised it was approved.

“Not going to happen on basis of data presented to date,” posted an anonymous salesman on industry chatroom cafepharma when approval rumors first surfaced. “Think about it. What is the label going to say? Improvement in PFS but not sure of clinical relevance of this. No improvement in overall survival. FDA is not going to do it.”

Just because Vioxx caused 27,000 cardiac deaths, Avandia was found to increase cardiovascular death risk by 64 percent and Vytorin proved worthless in improving cardiovascular health all after approval, “The senator is demanding a full-scale review of each and every product ever approved,” whines Thornton, “to ensure that drugs approved on surrogate endpoints are both safe and effective.”

Imagine that.

Of course surrogate endpoints–short-term criteria a clinical study is judged on in lieu of mortality or survival data–vaulted to national fame when Merck and Schering-Plough sought to alter theirs in the suppressed ENHANCE study to keep Vytorin from looking like a national con job.

Surrogate endpoints spell Ka-Ching to the drug industry because it can start blitzing a drug while safety data is still out and Wall Street is sitting up and listening.

And if the drug turns South as it’s used by the first patients/guinea pigs, it’s cheaper to ask for forgiveness than permission; Merck, after all still made money on Vioxx despite its $4.85 billion settlement with tens of thousands of plaintiffs.

But the problem with surrogate endpoints is: your actual mileage may vary.

Vytorin reduced LDL but didn’t clear arteries.

Avandia lowered blood sugar but raised not lowered heart attack risk.

New osteoporosis drugs stop bone turnover but cause instead of prevent fractures. Oops.

Thornton served on the clinical review team for Erbitux® while at the FDA–the cancer drug at the heart of the Martha Stewart/ImClone scandal–and worries that “a change toward the much stricter endpoint of overall survival,” (sic) will chill innovation.

“U.S. cancer-drug development stands on a precipice overlooking a new dark age in which each new product’s development is longer and costlier than the last,” he writes.

Each new cancer drug is costlier, too, say health policy watchers.

Why does Erbitux® costs $17,000 a month? Avastin $4,400 a month?

Because the drug companies can get away with charging that much writes Robert Bazell, Chief science and health correspondent with NBC news, adding that if Avastin is added to the regimen for treating advanced colon cancer it would add $1.5 billion a year in new national health costs.

In a letter responding to Thornton’s oped– unsubtly titled Grassley’s War on Cancer Patients– Sen. Grassley says Thornton “mischaracterized” the GAO review and that it is an attempt “to make the relationship between the FDA and drug makers less cozy.”

He also observes that in addition to “volunteering as president of the Sarcoma Foundation of America,” Thornton is the Senior Vice President of Product Development at GenVec, Inc. which makes cancer drugs–a simple Google vett the Wall Street Journal didn’t include.

Thornton also served as Chief Medical Officer and Head of Product Development of Ziopharm Oncology Inc. and Managing Director of Clinical and Regulatory Affairs of Angiotech Pharmaceuticals and is on the Board of Directors of the partially drug industry funded Center for Medicine in the Public Interest (CMPI).

But maybe those are his career’s surrogate endpoints.

Disclosure composure

Dear Ms. Rosenberg,

I appreciate and respect your point of view raised in your piece. Indeed in my advocacy pieces, I do not mention the various companies I have worked for, since to do so would presuppose that they share my personal views. While fair to them, I fully understand how easy it is to believe that evil motives are at work in such a position.

It is unfortunate that we live in a time of such deep mistrust of motives of individuals. I consider my advocacy on behalf of cancer patients to be bipartisan and centrist, and engage often with advocactes on both ends of the political spectrum.

At any rate, I hope that through all the easy shots you took at all the fish in my barrel, one could appreciate that my views are not totally corrupted, and to perhaps consider the peril we may very well be in in being able to get new therapies out there for cancer patients.

Regarding profits in this industry, any bipartisan measures that you feel would help curb the profiteering going on in the industry when new cancer therapies get approved, I would surely support and mention to my fellow cancer advocates.

My best to you,

Mark Thornton

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).

bernie-the-sandernistas-cover-344x550

June 24, 2019
Jim Kavanagh
Eve of Destruction: Iran Strikes Back
Nino Pagliccia
Sorting Out Reality From Fiction About Venezuela
Jeff Sher
Pickin’ and Choosin’ the Winners and Losers of Climate Change
Howard Lisnoff
“Bomb, Bomb, Bomb Iran”
Robert Fisk
The West’s Disgraceful Silence on the Death of Morsi
Dean Baker
The Old Japan Disaster Horror Story
David Mattson
The Gallatin Forest Partnership and the Tyranny of Ego
George Wuerthner
How Mountain Bikes Threaten Wilderness
Christopher Ketcham
The Journalist as Hemorrhoid
Manuel E. Yepe
Yankee Worship of Bombings and Endless Wars
Mel Gurtov
Iran—Who and Where is The Threat?
Wim Laven
Revisiting Morality in the Age of Dishonesty
Thomas Knapp
Facebook’s Libra Isn’t a “Cryptocurrency”
Weekend Edition
June 21, 2019
Friday - Sunday
Brett Wilkins
A Brief History of US Concentration Camps
Rob Urie
Race, Identity and the Political Economy of Hate
Rev. William Alberts
America’s Respectable War Criminals
Paul Street
“So Happy”: The Trump “Boom,” the Nation’s Despair, and the Decline of Joe Biden
Jeffrey St. Clair
Roaming Charges: Ask Your Local Death Squad
Dr. Vandana Shiva
Fake Food, Fake Meat: Big Food’s Desperate Attempt to Further the Industrialisation of Food
Eric Draitser
The Art of Trade War: Is Trump Winning His Trade War against China?
Melvin Goodman
Trump’s Russian Problem
Jonathan Cook
Forget Trump’s Deal of the Century: Israel Was Always on Course to Annexation
Andrew Levine
The Biden Question
Stanley L. Cohen
From Tel Aviv to Tallahassee
Robert Hunziker
Permafrost Collapses 70 Years Early
Kenn Orphan
Normalizing Atrocity
Ajamu Baraka
No Dare Call It Austerity
Ron Jacobs
The Redemptive Essence of History
David Rosen
Is Socialism Possible in America?
Dave Lindorff
The US as Rogue Nation Number 1
Joseph Natoli
The Mad King in His Time
David Thorstad
Why I’m Skipping Stonewall 50
Michael Welton
Native People: Changing Our Ways of Seeing
Peter Bolton
The US-UK “Special Relationship” is a Farce
Ramzy Baroud
‘World Refugee Day’: Palestinians Keep Their Right of Return Alive Through Hope, Resistance
Louis Proyect
The Douma Gas Attack: What’s the Evidence It was a False Flag?
Binoy Kampmark
Nigel Farage’s Grand Tour of Sabotage
Brian Cloughley
Trump’s Sanctions are Sadistic and Spiteful
Norman Solomon
Clueless and Shameless: Joe Biden, Staggering Frontrunner
Tom Clifford
Hong Kong is Far From China’s Biggest Problem
Lawrence Davidson
On the Alleged “Preciousness of Life”
Mel Gurtov
Impeach Trump
Rajan Menon
America’s Suicide Epidemic: It’s Hitting Trump’s Base Hard
Dan Bacher
Oregon Governor Kate Brown Signs Five-Year Fracking Ban Bill
Ralph Nader
Congressional Interns and Congress Redirections—A Meeting
FacebookTwitterRedditEmail