April 18, 2014

FDA Stands Between Terminally Ill And Experimental Drugs

Pills in bottles FDA Stands Between Terminally Ill And Experimental Drugs

By Attorney Jonathan Emord
National Health Federation

In the 1973 science fiction film Soylent Green, directed by Richard Fleisher and starring Charlton Heston as Thor, the government combined with industry to euthanize people deemed of low social utility and use their corpses to make a food source called Soylent Green, which was then fed to a starving population unaware of its true source. Whenever government supplants the right of an individual in making penultimate treatment decisions in the face of terminal illness, the people are robbed of their right to liberty and to life. The grotesque abuse of government power portrayed in Soylent Green has a modern corollary in the FDA that is equally horrific.

Under FDA regulations a patient who is terminally ill may only gain access to an investigational drug if the FDA approves. FDA approval is required even if the attending physician recommends the drug and the sponsor is willing to provide it. In this way, FDA stands between the terminally ill and access to potentially life saving drugs. Hundreds of people have been deprived of all hope and freedom of choice by the barbaric exercise of life-ending power by the Food and Drug Administration.

In 1999 Abigail Burroughs, a nineteen year old University of Virginia student, was diagnosed with a rare cancer of the head and neck. For eighteen months, she underwent painful chemotherapy and radiation treatments, those approved by FDA, to no avail. In March of 2001, Abigail and her parents were informed that the FDA approved treatments had failed and that her only hope lay in gaining access to investigational drugs, Erbitux and Iressa, then undergoing clinical trials. Abigail’s cancer cells had very high Epidermal Growth Factor Receptors, and EGFRs had been shown preliminarily to be greatly suppressed by these two experimental drugs. The sponsors of the drug trials were willing to provide the experimental drugs to Abigail, but they had to first obtain the consent of the FDA. The FDA refused to grant its consent, and Abigail died on June 9, 2001, at the age of twenty-one.

In the spring of 2001 sixteen year old high school student David Baxter was diagnosed with colorectal cancer. Although there was little chance that FDA approved chemotherapy would be successful, he proceeded through his chemotherapy rounds. David was denied access to investigational drugs by FDA on the basis that he was not yet eighteen, and the trials were said to be only available for those eighteen and older. He died shortly before his seventeenth birthday on July 20, 2002.

Kianna Karnes was a forty-four year old mother of four and grandmother of one when she was diagnosed with kidney cancer that was said to have metastasized. Two different investigational drugs, BAY 43-9006 and SU 11248, were promising for what was regarded as an otherwise untreatable disease. Despite appeals for access to the drugs, FDA refused to grant access until her condition had advanced to its final stage. FDA refused to grant Karnes access to one of the experimental drugs but finally changed its position, issuing notice of a grant of access to Karnes on the day she died in 2005.

Thirteen year old Anna Tomalis was diagnosed with embryonal sarcoma. She underwent FDA approved chemotherapy and surgery but both failed. Her parents then endeavored to have Anna treated with an investigational drug, Deforolimus, developed by Merck and ARIAD. FDA refused to grant Tomalis access to the drug until three weeks before she died, at a stage of cancer progression beyond that effectively treatable by the investigational drug.

Many, like Patricia Clarkson (the subject of my article for Newswithviews entitled FDA Condemnation of the Terminally Ill), are presently diagnosed with terminal cancer and have been informed that FDA approved treatments are not likely efficacious, yet their requests for access to investigational drugs have been denied by the FDA.

On August 3, 2012, Congressman Ron Paul introduced the Compassionate Freedom of Choice Act, HR 6342. Under that bill, if a patient has been diagnosed with a terminal illness and a physician has determined that FDA approved drugs and devices are unlikely to be curative, the patient may obtain access to an investigational drug if the sponsor is willing to supply it and the patient executes an informed consent. The bill removes FDA from the picture, restoring medical freedom to the patient and the practice of medicine to attending physicians. The bill also removes a perverse incentive now present in FDA regulations. FDA requires sponsors of clinical trials to report the results of treatments to those given compassionate access. Because adverse findings may have an impact on drug approval, sponsors are often dissuaded from granting access for fear that it will redound to their detriment in the drug approval process. Congressman Paul’s bill eliminates the requirement that any information concerning compassionate access be supplied to the FDA.

Congressman Paul’s bill is co-sponsored by Congressmen Charles Broun of Georgia and Richard L. Hanna of New York. It is pending before the House Energy and Commerce Committee, chaired by Fred Upton of Michigan. On this bill depends the lives of many terminally ill patients. Without the bill, every terminally ill patient who seeks access to an experimental drug must grovel before the FDA, begging for the right to receive the drug which is that person’s only hope for survival. No American, and certainly none fighting to remain alive, should be subjected to that humiliation, and no person in government, and certainly not an FDA bureaucrat, should ever stand between the terminally ill and access to a potentially life-saving drug.

I list here each member of the Energy and Commerce Committee. Please examine the list. If your member of Congress is on it, I urge you to call or email him or her today. Ask your representative to co-sponsor HR 6342. If your member of Congress is not on this list, please call or email the chairman of the committee, Fred Upton of Michigan, and urge him to co-sponsor this bill. This is not a partisan issue, it is a humanitarian measure of critical and immediate need.

Republican Members, 112th Congress

Fred Upton (MI)
Joe Barton (TX)
Cliff Stearns (FL)
Ed Whitfield (KY)
John Shimkus (IL)
Joseph R. Pitts (PA)
Mary Bono Mack (CA)
Greg Walden (OR)
Lee Terry (NE)
Mike Rogers (MI)
Sue Myrick (NC)
John Sullivan (OK)
Tim Murphy (PA)
Michael Burgess (TX)
Marsha Blackburn (TN)
Brian P. Bilbray (CA)
Charles F. Bass (NH)
Phil Gingrey (GA)
Steve Scalise (LA)
Bob Latta (OH)
Cathy McMorris Rodgers (WA)
Gregg Harper (MS)
Leonard Lance (NJ)
Bill Cassidy (LA)
Brett Guthrie (KY)
Pete Olson (TX)
David McKinley (WV)
Cory Gardner (CO)
Mike Pompeo (KS)
Adam Kinzinger (IL)
Morgan Griffith (VA)

Democrat Members, 112th Congress

Henry A. Waxman (CA)
John D. Dingell (MI)
Edward J. Markey (MA)
Edolphus Towns (NY)
Frank Pallone, Jr. (NJ)
Bobby L. Rush (IL)
Anna G. Eshoo (CA)
Eliot L. Engel (NY)
Gene Green (TX)
Diana DeGette (CO)
Lois Capps (CA)
Michael F. Doyle (PA)
Jan Schakowsky (IL)
Charles A. Gonzalez (TX)
Tammy Baldwin (WI)
Mike Ross (AR)
Jim Matheson (UT)
G. K. Butterfield (NC)
John Barrow (GA)
Doris O. Matsui (CA)
Donna Christensen (VI)
Kathy Castor (FL)
John Sarbanes (MD)

© 2012 Jonathan W. Emord – All Rights Reserved

Jonathan W. Emord is an attorney who practices constitutional and administrative law before the federal courts and agencies. Congressman Ron Paul calls Jonathan “a hero of the health freedom revolution” and says “all freedom-loving Americans are in [his] debt . . . for his courtroom [victories] on behalf of health freedom.” He has defeated the FDA in federal court a remarkable eight times, six on First Amendment grounds, and is the author of Amazon bestsellers The Rise of TyrannyGlobal Censorship of Health Information, andRestore the Republic. He is also the American Justice columnist for U.S.A. Today Magazine. For more info visit Emord.com.

Read the full article and comment here:  http://www.thenhf.com/article.php?id=3433

 

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