- The Washington Times - Friday, May 6, 2005

Mrs. Clinton’s about-face

Sen. Hillary Rodham Clinton may well rue the letter she sent to Secretary of State Condoleezza Rice advocating that the Bush administration hold bilateral talks with Pyongyang, North Korea (“Political cheap shots and North Korea,” Editorial, Tuesday). Mrs. Clinton strongly supported Sen. John Kerry in the 2004 presidential race and Mr. Kerry’s pounding of President Bush for going it alone by ignoring France, Germany and Russia in Iraq.

Mrs. Clinton’s about-face, advocating that the United States go bilateral, ignoring South Korea, Japan, Russia and China vis-a-vis North Korea, will be remembered by voters in the red states she has started wooing so ardently.

Surely Mrs. Clinton’s amnesia is not so severe that she forgets that in 1994, Jimmy Carter single-handedly negotiated with Pyongyang her husband’s failed Agreed Framework.

WILLIAM H. SMITH

Palm Desert, Calif.

No drug is perfect

The Commentary piece, “FDA in a pain-pill panic,” (April 26), illustrates once again that some in our society demand nothing less than perfection and risk-free drugs to alleviate pain and suffering in our nation.

An article in the Journal of the American Medical Association by a Harvard epidemiologist suggested that “clinicians should avoid using new drugs when older, similarly efficacious agents are available.” The author claims: “Millions of patients are exposed to potentially unsafe drugs each year,” a statement that is unreasonable at best and sensationalist at worst.

There is no doubt that the Food and Drug Administration is under severe scrutiny, with some even suggesting that it is failing to keep dangerous drugs from consumers. Although I completely disagree with that assessment, it is true that the agency seems to be taking an ultra-cautious approach in the approval process.

Bringing a newly developed drug to market is a costly and time-consuming effort. No one in the chain of the drug development process, especially the pharmaceutical companies, wants to have a product adversely affect those it is meant to help.

Simply stated, there is no 100 percent safe and effective drug for all users all the time. It is more a matter of how a drug is used (dose, frequency and duration), for what it is used (the severity of the condition treated) and with what other drugs is it used (the interaction problem).

There are examples of drugs that have gone through the approval process and have been on the market for years before some serious adverse reactions have turned up. In the meantime, thousands — perhaps millions — have been helped.

Another point: The more severe the consequences of the condition we are treating, the more we accept adverse reactions. This is the concept of risk-benefit ratio. It may be different for each one of us, but it is a choice the drug developers and regulators must ultimately reserve for the physician and the patient.

DR. CHARLES H. PIERCE

University of Cincinnati College of Medicine

Board member

Annapolis Center for Science-Based Public Policy

Cincinnati

The Commentary column by Donald Devine, “FDA in a pain-pill panic,” was on target in so many ways I hardly know where to begin.

My daughter, Kianna Karnes, died March 24 of metastasized kidney cancer. She desperately wanted access to one of two drugs that are in development and show a lot of promise in treating her specific cancer.

However, she became ineligible for a clinical trial because her cancer had spread, and brain tumors showed up. So we tried to get her access to either of the drugs under compassionate-use rules.

Compassionate use of drugs that have not yet been approved by the Food and Drug Administration (FDA) is indicated when the only alternative is death. However, neither of the drug companies, Bayer or Pfizer, would go along. Basically, they seemed to blame their reluctance on FDA rules, and I think they probably were right.

That brings us to the points made by Mr. Devine. He said, “Rule No. 1 for bureaucratic regulators is: What you do can get you in trouble with activists and politicians, what you deny no one can see. The ideal would be approving no drugs so no one could get hurt using them (nor blame the approving bureaucrat). The next best is to test them to death over the longest period possible in an effort to eliminate all risk.”

That is exactly the strategy the FDA is pursuing, and I’m sure it will drag out the new drug-approval process even further in the aftermath of the recalls of Vioxx and Bextra. As Mr. Devine said, though, “The only little problem is people die during the endless approval process.” My daughter died while waiting for approval of either BAY43-9006 from Bayer or SU11248 from Pfizer.

In fact, according to the California Kidney Cancer Foundation, 33 people die every day with metastatic kidney cancer.

And that is not the end of it. Thirty-three deaths a day translates to approximately 12,045 deaths each year from kidney cancer alone. The American Cancer Society estimates that 570,280 Americans will die from all cancers combined during 2005.

Would every one of those half-million plus people be saved by faster drug approvals and by opening up unapproved drugs to compassionate use? No, of course not. But many — probably thousands — would be saved. Many patients would be allowed to live out their normal life expectancies, and many families would be spared the indescribable grief that I feel, if only we can stop the bureaucratic ineptitude at the FDA.

Mr. Devine correctly stated that the FDA bias toward endless testing is most noticeable for patients with incurable diseases. Once again he is right on target.

Why can’t FDA bureaucrats get it through their heads that there is a difference between cancer and toenail fungus? Let them require tests until the cows come home for drugs for use by otherwise healthy people who have a rash, ache or pain.

But when people face death and, like my daughter, are willing to sign documents indicating that they know the experimental nature of the drug and are willing to accept the risks, give them a chance at life.

JOHN ROWE

Oxon Hill

Real ID not the answer

The Real ID Act indeed may provide some of the benefits listed in your editorial regarding immigration reform and homeland security (“A victory for common sense,” yesterday). However, there are a number of downsides to consider, as well.

You state that “several of the hijackers had in fact obtained numerous driver’s licenses from several states.” The Real ID bill would not change any of this, as the black-market fake document business would adjust to provide unseemly characters with the documentation necessary to obtain a Real ID card.

What would be done with the millions of people who have experienced identity theft? The law-abiding citizens who have already experienced identity theft will have to worry about criminals obtaining these cards in their names.

In most cases, identity theft assures that the criminals would already have the requisite information to fraudulently obtain these cards. The massive additional databases that store the personal information of the people who acquire the Real ID cards would be another avenue for hackers and criminals to perpetrate ID theft on an entirely fresh and unsuspecting public.

The Real ID card is not a panacea for immigration reform and homeland security, and the cure may be worse than the disease.

BEN BERRY

Washington

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