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A Plea to Save Orphan DrugsUntil you...

THE BALTIMORE SUN

A Plea to Save Orphan Drugs

Until you or a family member suffer from an incurable rare

disease, altering the Orphan Drug Act of 1983 may seem like a good idea. For those of us who witness the pain and anguish of these diseases firsthand, changing this law poses terrible and unacceptable risks.

My teen-age sons, Dean and Damien Storm, have cystic fibrosis, a genetic disease that affects mainly their lungs and digestive systems. Ultimately, they learn to breathe on less and less. Cystic fibrosis causes a slow and painful build-up of thick, sticky mucus in the lungs, which eventually suffocates the victim, leading to death.

Only about 50 percent of our cystic fibrosis children and young adults reach their mid-twenties. So far there is no cure.

Over the years the boys have been exposed daily to numerous antibiotics, both orally and intravenously. They also take 30 capsules each for digestion and need chest physical therapy on a daily basis.

Despite their illness, however, they are experiencing life to the fullest. Over the years, both boys have benefited from a chronic health-impaired program through the Upton School, which has given them the opportunity to be taught during their illnesses and not marked absent.

The boys have been in the German exchange program and on the soccer team, although their physical endurance is somewhat limited. Dean and Damien are 11th and 12th-grade honor students at Baltimore City College. Dean is graduating this June and plans to attend Towson State on a full scholarship. His goal is the journalism field.

The costs involved for treating this disease are tremendous. Last year, their prescription drugs were approximately $3,000 each for the year, not including the additional thousands when treated with intravenous drugs for two-week to three-week periods, frequent outpatient visits to the hospital, cases of Ensure Plus to help them gain weight, fat-soluble vitamins, etc.

In spite of their increased lung problems and daily challenges, the boys could not be more hopeful. They are currently involved in a DNase study (DNase is a synthetic enzyme) in the third stage of clinical trials, where the drug has been known to improve lung function 15 to 20 percent. If it's approved by the FDA, all of our cystic fibrosis children could benefit.

The scientific breakthroughs are tremendous. We are within a few years of a cure. All of this is possible through the research efforts that are finally paying off after so many years, so many lost lives.

Congress passed the Orphan Drug Act in 1983 to provide incentives for drug companies to develop drugs for orphan diseases, those afflicting fewer than 200,000 people each. The reasoning was that, since it can cost hundreds of millions of dollars to research and develop a new drug, it just didn't pay to develop drugs with very limited markets.

This was especially true for biotechnology breakthroughs and other products, which are not otherwise eligible for the regular 17-year patent protection available to most new drug discoveries. The most important feature of the law is a seven-year period of elusive marketing rights, which acts like a patent for these medicines.

In the nine years since this law has been in effect, 64 orphan drugs have been developed to treat 74 rare diseases, including hemophilia, leprosy, sleeping sickness and severe combined immunodeficiency disease -- the "bubble boy" disease.

Despite this progress, there are still some 10 million to 20 million Americans who suffer from the 5,000 rare diseases for which there is no effective treatment. Those of us who suffer from these diseases, or have close relatives who do, don't want the wheels of progress to stop before it's our turn. But now, misguided legislative efforts threaten to cripple this provision.

Under a proposed amendment, Senate bill S.2060, orphan drugs would lose their patent-like exclusivity once sales reach an arbitrary "sales cap" of $200 million.

People promoting this change say it will make orphan drugs more affordable. But there is no proof of that at all. Logic suggests that because of the limited market size of orphan disease populations, drug costs will increase because manufacturers will have smaller, more fragmented markets from which to recover their investments after losing exclusivity because of the S.2060 sales cap.

Everyone wants affordable drugs. But if the drugs are never discovered, the question of cost is academic. And the fact is that most drug companies have pledged -- in writing -- to provide orphan drugs free to patients who are uninsured or who cannot otherwise pay for the medicine they need.

The Orphan Drug Act works and should be left alone. If the prevailing amorphous Washington feeling pervades, that "something must be done," then I strongly advise that the Orphan Drug Act should be strengthened, so that individuals like my sons with cystic fibrosis can keep their hopes alive for a cure.

Like so many others fighting their personal battles against these tragic diseases, they want only the chance to live life to the fullest.

Joan Storm Rettaliata

Baltimore

What Memorial Day Means

What is Memorial Day to me? I guess it's why I fly the flag on national holidays and some other days, too, just because I feel like it. That's why I served in the U.S. Air Force and Army in Korea. All the things we value in this great nation were paid for in full.

It's remembering a long time ago as a young man so far from home and alone on a raw, dark November night with wind-blown snow cutting your face.

It's standing still on feet so cold you couldn't believe it possible if you weren't actually feeling it.

It's clutching a frosty carbine with stiff, gloved hands that were numb long before darkness fell over that gloomy Korean hillside.

It's forcing heavy eyelids to remain open and then open wide as wide can be as a fire-fight starts on the other side of that hill.

Some American boy will be paying the price again and again. I guess it's always been that way, standing firm in out-of-the-way places.

It's also speaking out loudly when anyone -- anyone -- tries to trample on those precious things your buddies felt worth dying for; yes, all the way from a little hill north of Boston to the powdered sands of a far off desert.

Two years ago I was in Europe on Memorial Day. I stopped off to visit with the boys who lie row on row. And as I walked past those crosses and stars, looking for Marylanders, the colonel I was with said, "Sure are a lot of privates here."

I stopped, looked back at him and said, "Who do you think fight all our damn wars?" He smiled and said he guessed I was right.

Yes, Memorial Day means to me that my family can live in peace. But most of all it means freedom, something you can't touch, see, hear or taste, but it's been purchased by thousands of Americans on battlefields around this world.

J. G. Kamps

Sparks

No Tube Boobs in Her Class, Please

It is important that your readers be aware of a new project the Baltimore City schools will initiate this fall.

of September, 1992, virtually every middle school and high school classroom in this city will be given a television monitor. Yes, given -- for free. Well, almost free. This generous donation is being made by "Channel One." In exchange, we need only give our children.

Channel One will air programs geared to young people, including regular, high-impact advertising, also geared specifically to young people. This means that our kids will be a captive audience for advertisers trying to sell them shoes and sweat suits and stereos and junk food. Since our kids are required to come to school, once Channel One is in place in every classroom, and once teachers are encouraged and "taught" to integrate Channel One's programming into their lessons, the advertising will become part of the required subject matter. Channel One, a for-profit entity, and the advertisers have certainly struck gold.

The argument may be made that the program content of Channel One will be educational. No doubt. My response is this: The last thing any child needs is more television, no matter how "educational." In the case of many of our inner city students, the use of TV in the classroom is particularly heinous.

These kids' lives are bloated with television: hours after hours after countless hours. The school should be showing them an alternative.

In addition, many of these kids are so very deprived of profound human interaction -- interaction in which they are the focus and the priority -- that our classrooms may be the only place they can experience it. The classroom is a safe, well-ordered and relatively quiet place where they can talk and be listened to, where they can learn to listen to others, where they can experience human relationships outside their own, perhaps very damaged, family and neighborhood environments. Now we're going to turn on the TV? What these kids don't need is more slickly packaged media productions. They can get those any day of the week, any hour of the day. What they need is us.

And they need us right now. Will educators comply with such an outrage? Will parents stand by while their children are delivered into the hands of advertisers? Who is protecting our children? Who will stand between them and Madison Avenue? Who will resist the power of the dollar and say, "No"?

L We tell our kids over and over to just say no. When will we?

Carolyn Moyer

Millersville

The writer is a teacher at Herring Run Middle School.

Morality: The Murphy Brown Debate Continues

For the White House to get into a stew over a sitcom instead of focusing on the problems of urban crisis seems, on the surface, to be trivializing a major issue.

But unfortunately, since America is absolutely addicted to television, any message poured out to 38 million viewers is a national issue which will have a more far-reaching affect on our cities than anything Dan Quayle or George Bush could offer.

Which show is likely to make its way into the minds of young unmarried women, "Murphy Brown" or a presidential message? That's part of the problem.

The other part is the message itself. Sex and pregnancy without commitment are okay, even glamorous. Raising a child with only one parent whose life is already predominantly occupied with a career will not have any detrimental effect on said child.

Everything will have a happy ending. Nowhere along the line will irresponsibility result in tragedy.

Is not the urban crisis a case of deprived children who are now adults? Do we need to encourage more mothers trying to make it with more babies and no fathers? Sure, it's better than having an abortion, but there are alternatives that consider the baby first, like birth control or, even more unbelievable, sex within the confines of a relationship with commitment.

In this day and age of severe loss of natural love for children, the message from this show was the exact opposite of what we needed.

Georgia Corso

Baltimore

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The family, consisting of a father, mother and children living together in one household, is the basic accepted world culture since biblical days. America and the whole of western civilization grew up with this standard for human existence.

Making babies out of wedlock with the father walking away from his responsibilities -- is that really the picture of modern America? The morality of our country has sunk to the bottom of the dung heap, led by the television industry where dollars are the only measure of "success."

With one stroke of the tongue, Vice President Dan Quayle has spoken out for all that should be right and decent in our country's family lifestyle.

With one speech he said it like it should be said -- one voice crying out from the wilderness -- and made himself a believable, serious person who has ingratiated himself into the hearts of our country's law-abiding, God-fearing citizens.

Philip R. Grossman

Pikesville

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The reaction of the media elite (I include Roger Simon and Michael Olesker in that group) to the vice president's "Murphy Brown" observation has been as unsettling as it was predictable.

My family and friends have long felt that the Murphy Brown pregnancy, more than a television joke, sends a very wrong message to society in general: parents, children, taxpayers and all. Single parenthood may certainly be managed. Widows and divorcees whom circumstances have forced into single parenthood are to be admired for their successes. Setting up a dramatic situation which gives credence to single parenthood out of wedlock by choice is another matter.

The family in our society is under great pressure because of economic problems, permissiveness, lack of religious convictions; the list goes on and on. What we don't need is a highly successful, attractive TV actress like Candace Bergen making a total mockery of family life and pregnancy as has been done in this silly burlesque in prime time.

Vice President Quayle was right to point this out. I'm only sorry President Bush didn't have the guts to back him to the hilt instead of waffling as he did and has done on so many other important and timely issues.

Franklin W. Littleton

Baltimore

Astro Van's Crash Test Results

The Evening Sun's May 11 editorial, "Astro Van's Scary Numbers," reports passenger van crash tests conducted by the National Highway Traffic Safety Administration (NHTSA) as part of its New Car Assessment Program.

First, let me emphasize that the Chevrolet Astro and GMC Safari vans meet or exceed all applicable federal safety standards.

The New Car Assessment Program test cited is conducted at five miles per hour above the federal standard of 30 mph, which amounts to a 36 percent increase in the energy of the crash and the potential for injury.

It involves the crash of one vehicle moving at 35 mph perpendicularly into an immovable concrete wall, one time, under one set of circumstances.

This is an impact condition seldom encountered in real life and it is subject to all the variables that are present in such one-of-a-kind tests.

A single test cannot realistically reflect the many real-world combinations of people sizes, seating positions, struck objects or impact orientations that show up in accident data.

Therefore, Highway Loss Data Institute complications are a better measure of the Astro and Safari vans' safety. The Highway Loss Data Institute's insurance-company data on injuries and accident repairs show results of real-world accidents by real drivers on real roads across America.

The Highway Loss Data Institute is quoted in the editorial. However, no reference to the statistics quoted can be found in the institute's report. Interestingly, you neglected to cite similar information for competitive vehicles.

In addition, the editorial failed to reveal that institute information indicates that in the real world vans are among the safest vehicles on the highway. The institute reports the injury claim frequency on the Astro van is 30 percent better than average of all 1988-90 passenger cars and small vans.

Furthermore, occupant death rates for the vans are much lower than predicted by vehicle size and driver profile, according to Insurance Institute for Highway Safety date.

It is important to note that since 1991, all passenger-model Astro vans have come equipped with four-wheel anti-lock brakes as standard equipment.

Contrary to your implication that anti-lock brakes are just "a nice feature," it helps the driver avoid accidents by permitting steering and hard braking at the same time -- without locking up the wheels.

Robert R. Rieman

Baltimore

The writer is GM Truck & Bus-Baltimore assembly plant manager.

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Kudos to The Sun for alerting consumers about the dangers of the Chevrolet Astro (May 5).

Let there be no doubt that consumers value such information. Even Detroit finally admits that safety sells. If GM dislikes the adverse publicity, it should put air bags in the Astro -- pronto. Chrysler, with a fraction of GM's assets, put a driver air bag in the Dodge Caravan. The result: the best crash-test results of any van tested in the program's 15-year history.

Vehicle crashes are the leading killers of Americans under age 45 and the leading cause of head injuries, paraplegia and quadriplegia. The information in your article can save your readers' lives. Thank you for caring enough to tell it like it is.

Rosemary Shahan-Dunlap

McLean, Va.

The writer is president of Motor Voters, a consumer safety group.

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