Letters To The Editor

LETTERS TO THE EDITOR

December 28, 2005

FDA sets standard for drug safety

Merrill Goozner is misguided in questioning the thoroughness and safety of the Food and Drug Administration's drug approval process, which has been held up as the worldwide standard for safety ("Protocol of convenience," Opinion

Commentary, Dec. 19).

The user-fee law he referenced was implemented in 1993 and has had no impact on safety, contrary to Mr. Goozner's assertions.

The safety record is clear - in the last 20 years, fewer than 3 percent of medicines have been withdrawn from the market for safety reasons.

This remarkable record is indicative of the FDA's exhaustive approval process: It takes 10 to 15 years for just one drug to be approved, and that includes up to 7.5 years of clinical trials with thousands of volunteer patients.

Approving one medicine involves hundreds of thousands of pages of scientific data, all of which are reviewed by the FDA before the product is approved.

Patients can find clinical testing information online at the clinical trials registry of the National Institutes of Health.

I strongly support the site as an important resource for physicians and patients seeking information about ongoing clinical trials.

While a clinical trial should not be viewed as a treatment option, such trials can provide access to promising new therapies for seriously ill patients with few other options.

And, ultimately, a successful and robust clinical trial can lead to new cures for patients.

Ken Johnson

Baltimore

The writer is a senior vice president of the Pharmaceutical Research and Manufacturers of America, a drug industry trade and lobbying organization.

Scorning liberties won't keep us safe

I find it appalling that Cal Thomas is so willing to sacrifice our civil liberties for an illusion of safety ("Preoccupation with civil liberties could end up costing us much more," Opinion * Commentary, Dec. 21). Where is the evidence that the Patriot Act has made us any safer?

Mr. Thomas says, "But civil liberties mean nothing if you're killed by a terrorist who has manipulated the Constitution to achieve his or her objectives."

Do civil liberties mean any more if you are murdered during a robbery attempt?

Far more people are killed by common criminals than by terrorists, and they also "manipulate" the Constitution to escape justice.

Perhaps we should just do away with the Fourth and Fifth Amendments entirely, since they're such a hindrance to law enforcement.

But is anybody really so naive as to believe that we would all be safe if we did that?

Mr. Thomas also objects to Sen. John McCain's bill to ban torture because our enemies won't do likewise. He seems unaware that torture is not a way to obtain reliable information.

I think the United States should be held to a higher standard than that of what our enemies do or do not do.

And if terrorists do manage to kill thousands or millions of us, it won't be because some government agent failed to torture someone.

Eric Haas

Edgewood

Oath is to defend the Constitution

Cal Thomas' column "Preoccupation with civil liberties could end up costing us much more" (Opinion * Commentary, Dec. 21) suggests that the president swore in his oath of office to protect this country and its citizens from all enemies, foreign and domestic.

It would be good for all citizens to understand why that is false.

Each president recites the following oath, in accordance with Article II, Section I of the U.S. Constitution: "I do solemnly swear (or affirm) that I will faithfully execute the office of President of the United States, and will to the best of my ability, preserve, protect and defend the Constitution of the United States."

By design, the president swears to defend the Constitution because, in the long run, that is more important than defending the people.

And our system of government has other mechanisms to defend its people.

Peter McCullough

Lutherville

Inclusiveness isn't attack on Christmas

I was a little bemused and amused by the letter "Attack on Christmas harms our heritage" (Dec. 23), and I was wondering whose heritage the writer was referring to.

It can't be the American heritage, because the Constitution guarantees against a national religion and protects minorities from the tyranny of the majority.

It also guarantees individual rights and freedoms that cannot be abridged by governments or interest groups.

While it is true that most people in the United States are white and Christian, it is imperative that we don't consider ourselves to be a white, Christian nation.

So chill out. There is no war against Christmas, nor is there a war against Christians.

But it does appear that there is a dawning recognition that a more generic holiday greeting such as "Happy Holidays" will be more inclusive of all groups who celebrate around the winter solstice.

Howard Albert

Joppa

No need for clerks to ratify our faith

There are so many reasons to celebrate this time of year - from ancient solstice feasts to faith-filled holy seasons.

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