THE VIRGINIAN-PILOT
Copyright (c) 1996, Landmark Communications, Inc.
DATE: Sunday, April 21, 1996 TAG: 9604170041
SECTION: REAL LIFE PAGE: K2 EDITION: FINAL
COLUMN: THE IMPERFECT NAVIGATOR
SOURCE: Alexandria Berger
LENGTH: Medium: 83 lines
WHEN I WAS diagnosed with Systemic Lupus in 1982, I flew to Canada to obtain a life-saving drug unavailable in the United States.
A doctor I'd arranged to meet there wrote the prescription. I filled it at a local pharmacy, charged the $500 price to my MasterCard, took the first dose and returned to the States.
This convoluted process cost me $32 duty, plus airfare. For the next seven years I refilled the prescription by phone and received it by mail.
I am not alone. Others have had their life-saving medications confiscated at Customs checkpoints and have traveled thousands of miles for treatments and medications approved in foreign countries possessing more stringent testing regulations than our own.
American citizens have been forced to travel abroad for life-saving surgical techniques performed with new medical devices unavailable here.
The Food and Drug Administration has repeatedly played a delaying game with the approval of new medications, new medical devices, and older medications still in clinical trials. Delays can mean the difference between life and death - or between a high-quality life and living hell.
So, on March 27, 14 years after my trip to Canada, the House of Representatives' Committee on Commerce unveiled a series of proposals to ``streamline the process by which the Food and Drug Administration approves new drugs, medical devices and foods.''
The agency also promised to provide ``fast track,'' expedited review for those medicines aimed at ``serious and life-threatening conditions.''
I yawned.
After speaking with Commerce Committee staffers and reading drafts of the proposals, I've concluded that the whole business is no more than election-year hype.
For starters, no one at Commerce would define for me what ``serious and life-threatening,'' means, specifically. And without that definition - and a list of specific diseases and conditions that meet it - all the talk is just that.
Dr. David Kessler, America's ``drug czar'' and the FDA's head honcho, has repeatedly fought to maintain the FDA's autonomy, even to the point of attempting to have his own independent police force. Kessler is famous, as is everyone at the FDA, for using the old ``thalidomide fear'' excuse to delay new drug applications.
Thalidomide, you'll remember, was a German-made tranquilizer that caused severe birth defects. Kessler has effectively cited fears of similar side effects when speaking of safety and efficacy.
The chief sponsor of the bill, Commerce Committee Chairman Thomas J. Bliley Jr. (R-Va.), may be trying to change the FDA's ways more to satisfy an economic goal than anything else.
The big dollar sign seems to be slipping away from American drug, biotech and medical device companies, which are now moving overseas. ``While the FDA buries research scientists and medical pioneers with red tape and delay, our foreign competitors are rushing to embrace them,'' Bliley says.
The upcoming election, PAC groups, the European Economic Union and the American Pharmaceutical Association figure in this latest rash of bill-making, as much as we, the American patients who require medicines for ``serious or life-threatening'' illnesses.
However, the bottom line is that crusading politicians in D.C., no matter what their real agenda, are offering us an opportunity to change things.
In February, more than 300 patients' organizations and individuals signed an open letter to Congress calling for statutory reforms to speed the FDA approval process, because of the bureaucracy at the FDA.
We need to join that effort now. If we don't take advantage of the situation, we may be looking at another 14 years - or, at the least, another election - before the subject is again on the table.
Write this to your congressman immediately:
``As an American citizen, I demand amended legislation requiring the FDA to urgently review and approve all new drug applications designed to combat all `serious and life-threatening illnesses.' ''
Send it to: House Commerce Committee, 2125 Rayburn House Office Building, Washington, D.C., 20515, or e-mail the committee at: commerce(at)hr.house.gov. You can fax your letter to (202) 225-1919. MEMO: Write Alexandria Berger in care of Real Life, The Virginian-Pilot, 150
W. Brambleton Ave., Norfolk, Va. 23510.
by CNB