Personal Responsibility and Individual Development for Everyone Act - Continued

PERSONAL RESPONSIBILITY AND INDIVIDUAL DEVELOPMENT FOR EVERYONE ACT-CONTINUED
NATIONAL PUBLIC RADIO

Mr. DURBIN. Mr. President, last week I took the floor of the Senate to note the decision which has been made by National Public Radio concerning the host of Morning Edition with Bob Edwards. It was announced in the Washington Post that National Public Radio management had decided after some 24 years to relieve Mr. EDWARDS of his responsibility as host of the morning show. There was not much given by way of explanation, and it was clear from comments by Bob Edwards that it wasn't his decision.

It has been interesting since I took the floor and noted my disappointment over that decision the response which I received from my colleagues in Congress. It turns out Members of Congress on both sides of the aisle feel as I do-that this decision by National Public Radio is the wrong decision; that Bob Edwards, who has been not only a host of this program but the most successful morning voice in America, is being moved away from this assignment in a situation and in a circumstance that is almost impossible to understand.

Many of my colleagues have come to me and asked, What can we do? Can we go after the appropriations of NPR? I don't recommend that at all. I think National Public Radio is such an important institution more than any single individual that we should do this in a positive and constructive fashion.

What I encourage my colleagues to do is to remember that National Public Radio is, in fact, public radio; that all of us who enjoy it so much, who rely on it so much, and who contribute to it from our own individual finances, have a responsibility if we disagree with this decision by the management. I have encouraged my friends and those who feel as I do to get onto their Internet and e-mail, and to e-mail NPR.org, to do it immediately and let them know that their decision to remove Bob Edwards at the end of this month of April is the wrong decision. I have done it myself.

I have received a reply from Mr. Kernis which, frankly, I find very troubling. When asked why they think this man who has become such an institution in America should be removed, the response is nothing short of gobbledygook. They talk about bringing someone who has depth and experience. But who else would you turn to rather than Bob Edwards?

I would like to make part of the RECORD at the end of my statement a series of columns and editorials from across the United States from those who enjoy Bob Edwards in the morning and can't imagine public radio without him. Some of these, starting with the Chicago Tribune, were published recently as the news reached that city of the decision by National Public Radio.

As they said in this editorial in the Chicago Tribune, people do not understand why this decision was made. Here is what they concluded in the Tribune editorial about Bob Edwards:

In contrast to their audience, though, NPR executives seem to have forgotten about the public part of their title. In commercial broadcasting, a beloved host who had presided over huge ratings gains would almost never be nudged aside. Public broadcasting is valuable precisely because it is relatively free from such worldly concerns. But it is also, effectively, a public trust, and for the public to continue to trust it, this institution needs to do a better job of explaining its momentous decisions. This is not the only newspaper, by far.

In the St. Louis area, Linda Ellerbee, known to many of us because of her news reporting and posting of programs wrote: "Time and Age: NPR Tossing Out Bob Edwards." Linda Ellerbee should know. She was moved away from a television network position because they thought for a woman she was too old. She says:

But we're not aging the way our parents did. We're reinventing the process. Besides, there are a lot of us out here.

The point she made in her article about Bob Edwards is at his advanced age of 56-which I still consider very young-he speaks not only to people of my generation but so many older and younger. If it is the marketing belief of NPR they need to have a new, fresh voice, they are missing the big picture.

For 24 years every morning when my clock radio goes on, I hear Bob Edwards. I know whether times are bad, dangerous, or peaceful. I can count on him. I have done it this morning. I have done it so many mornings. I cannot imagine "Morning Edition" without him.

There is also a comment from the Washington Post, Richard Cohen. He tells about the same experience.

Now the news from NPR is that Edwards will soon be gone.

He talked about the fact he may just decide to start listening to Mozart on disk, rather than turning on "Morning Edition." He says:

NPR Executive Vice President Ken Stern told the Washington Post that the firing of Edwards was part of a "natural evolution," that had "to do with the changing needs of our listeners." What "natural evolution"? What does that mean? And what is "changing needs"?

Mr. Cohen goes on to say to the Washington Post:

Listen, Ken, my needs haven't changed. I still want news in the morning. I still want smart features. I do not want interviews with airheaded celebrities a la Matt and Katie or, worse, interviews with the latest humorousless person Donald Trump has just fired from "The Apprentice."

He concludes:

But the firing-cum-transfer of Edwards (he may become a senior correspondent) is nonetheless disquieting. Maybe my fear is misplaced and maybe the end of the Edwards era will turn out not to be a bad thing. Still, it will be jarring to wake up in the morning with a stranger.

He closes by saying:

Goodbye, Bob. Get some sleep. You've earned it.

Mr. Cohen may have given up, but I haven't. I still believe the people across America should be contacting National Public Radio, npr.org. Send them your e-mail that Bob Edwards, "Morning Edition" is important to you. As a Senator, as a citizen, he is important to me.

The San Diego Union-Tribune in an editorial entitled "NPR Show Is a Big Hit, So It Must Need Fixing?" by Robert Laurence:

This story makes no sense.

As such, it's the kind of story that can only happen in the topsy-turvy Orwellian world of public broadcasting.

It's this: The host of a hugely successful morning radio show, a show where ratings have done nothing but climb for years, a man whose skill as an interviewer is unexcelled in the world of broadcasting, whose very voice helps millions of Americans get their day grounded, is being evicted from a seat in the studio.

Mr. Laurence goes on to say:

That's Bob Edwards, since November 1979 the host of National Public Radio's "Morning Edition . . . "

He goes on to talk about the explanations from NPR management, explanations he and I both find wanting. And Scripps Howard, Bill Maxwell and the St. Petersburg Times, entitled "A Morning Voice That Will Be Missed:"

All good things must come to an end.
And so it is with the ouster of Bob Edwards . . .
To say that Edwards is the end of an era is an understatement.
He continues:

Thanks in large part to "Morning Edition," when I report to the St. Petersburg Times editorial board each morning at 9:30, I know what's going on in the Nation and the rest of the world.

Millions of us would say the same thing.
Columbus Dispatch, Tim Feran: "Shame On NPR For Axing Edwards Before Big Date."
The big date, of course, is the 25th anniversary on the air. I agree with Mr. Feran.

The Cleveland Plain Dealer: "Not a Good Way To Start The Day," a title from Connie Schultz, a columnist. She writes:

The man I've been waking up with is leaving me.

She talks about her disappointment and how hard it is to understand why NPR is making this decision.
Turning to the Seattle Post Intelligencer, Bill Radke, a columnist, writes: "Mornings Without NPR's Colonel Bob."

He starts:

Bob Edwards has been canned, and there seem to be two types of people in the world: The ones saying, "You've ruined my life, Bob's life, and the lives of everyone I know," and the ones saying, "Who is Bob Edwards?" Those who did not listen to Bob Edwards may now never know. Those who do, understand full well.

The Hartford Courant, in Connecticut, by Jim Shea:

It's not often that you can use the words National Public Radio and stupid in the same sentence but such an occasion has arisen:

National Public Radio's decision to replace "Morning Edition" host Bob Edwards is just plain stupid. What are you bozos who run NPR thinking? You know, we've really got to do something about the fabulous ratings we have.

Bob Edwards is not just the bright, witty, urbane, insightful and immensely likable host of "Morning Edition," he is for the program's 13 million weekly listeners the voice of the morning.

There is something soothing, something comforting, something reassuring about stumbling from slumber into the gentle embrace of Edwards' mellifluous baritone that makes morning bearable.

He speaks for many people when he writes that.

Finally, on salon.com, Alexandra Marshall makes many of the same points about the importance of Bob Edwards' "Morning Edition."

Those who are following this debate may be puzzled as to why a Senator would stand up in this Chamber to make an issue over the replacement of a man who is, by all measures, just another voice in the morning. But Bob Edwards is not another voice in the morning. He is the voice we have counted on and the voice we rely on.

If he is as important to you as he is to so many of us, please, understand National Public Radio exists because of people like us who listen to it and contribute to it out of our own pockets, love it, and want it to continue to be the great institution which it is today. Those who are shareholders of National Public Radio by virtue of our contributions, if we disagree with this decision, have an obligation to tell the management right now.

I encourage those who feel as I do that the replacement of Bob Edwards is wrong, to do two things: First, go to your Internet, e-mail npr.org and let them know what you think; and second, call your local affiliate of the National Public Radio system and let them know this is a sad and sorry decision.

I yield the floor.

BREAK IN TRANSCRIPT

Mr. DURBIN. Mr. President, I thank the Senator from New Jersey for his leadership on this and so many issues. He expresses the feelings I have heard from soldiers returning from Iraq who are in Walter Reed Hospital recuperating, who are still strong in spirit and still dedicated to our country and hoping that we will help them win this battle and let them come home safely. There is a lot more we can and should do. I thank the Senator from New Jersey for his leadership in this area.

DIETARY SUPPLEMENTS

Mr. DURBIN. Mr. President, there has been an issue I have worked on now for almost 2 years relative to dietary supplements in America. We passed a law called the Dietary Supplement and Health Education Act in 1994. In passage of that legislation, we attempted to establish a standard for the legal treatment and regulation of dietary supplements. They are known to many Americans. It is a multibillion-dollar industry.

There are many of us who take vitamins and minerals and believe they are good for our health. I took one this morning. I hope it helps me. I don't think it will hurt me. For a lot of Americans, it is something they rely on.

There is another category that goes beyond ordinary vitamins and minerals, which are products known as dietary supplements. In many respects, what they consist of are herbal extracts, so-called natural products that are put in combination and sold in stores with many claims about whether they can help you from a health viewpoint.

Most Americans who walk into a drugstore, pharmacy, or nutritional supplement store believe the products on the shelf being sold to them are, in fact, safe. They may believe they have been tested. They may believe the proper clinical evaluation has been done. They may believe the Government is monitoring whether there is something wrong with the drug that causes a bad health event. Those beliefs are right and true and accurate, when it comes to prescription drugs. They have to go through extensive testing before they are ever put on the market. The FDA and many agencies look at them carefully to make certain they are both safe and effective-in other words, that they will not harm you and, in fact, will do what they are supposed to do and help you. That happens for prescription drugs, and it is what happens to the key ingredients in over-the-counter drugs.

When you walk into a dietary supplement store, a health store, that is not the case at all. What you see on the shelves there are products which, by and large, have never, ever been tested. Never tested. The law we passed said the makers of those products, unlike the pharmaceutical companies that make prescription drugs and some over-the-counter drugs, have no responsibility to test their products for safety before they are sold to the public. In fact, the burden is shifted 180 degrees. The Food and Drug Administration of the Government has the burden to prove that what is sold on the shelf is unsafe.

Think about that for a moment. Think of the hundreds, thousands, tens of thousands or more dietary supplements for sale in the U.S., and you come to the obvious conclusion that there is no Government agency large enough to test every possible combination that can be included in a dietary supplement. So the simple fact is very few are tested.

This week, Consumer Reports magazine reported on the issue of dietary supplements. I think a lot of this magazine. I have subscribed to it over the years. I think what they present is done in a very dispassionate and objective fashion. In this issue, they identify the problem we face in America with dietary supplements. They note the fact that U.S. consumers, since passage of the law I mentioned earlier, have literally spent billions of dollars on dietary supplements. They say it is interesting that for 10 years, although the FDA had the authority to remove an unsafe dietary supplement from the shelf, they never did. I will quote:

Yet, until very recently, the U.S. Food and Drug Administration had not managed to remove a single dietary supplement from the market for safety reasons.

After seven years of trying, the agency announced a ban on the weight-loss aid ephedra in December of 2003. And in March 2004 it warned 23 companies to stop marketing the body-building supplement androstenedione (andro).

That is a steroid precursor. Here we have it on the books for 10 years, with thousands of products that fall under its purview, and only two have been removed. Frankly, what it comes down to is described later by Bruce Silverglade, legal director of the Center for Science in the Public Interest, a Washington, DC, consumer advocate group:

The standards for demonstrating a supplement is hazardous are so high that it can take the FDA years to build a case.

Years-while the product is still being sold. How many people at the FDA are responsible for monitoring dietary supplements, a multibillion-dollar industry, with thousands of products? Their supplement division consists of about 60 people with a budget of only $10 million to police a $19.4 billion-a-year industry.

Consumer Reports goes on to draw this comparison:

To regulate drugs, annual sales of which are 12 times the amount of supplement sales, the FDA has almost 43 times as much money and almost 48 times as many people.

So it is very clear this agency is not prepared and staffed and, frankly, doesn't have the authority to protect the American consumer. So what happens? People unsuspectingly go into these health food stores, vitamin stores, and see the dietary supplements with all sorts of claims on them; they buy them, they use them, and the consumers of America become the guinea pigs.

We are the ones who are testing these products to see if they are dangerous. You might say, if they are dangerous, if they hurt someone, clearly then the Government will take them off the shelf, right? No, I am sorry, that is not right because understand that the law we passed at the request of the industry does not require dietary supplement manufacturers to report to the Government when people are literally dying from the products they sell.

I am sure many people listening to this debate say that cannot be true. It is true.

Let me give a specific example. Metabolife International, a leading ephedra manufacturer, did not let the Food and Drug Administration know it had received 14,684 complaints of adverse events associated with ephedra products. But Metabolife 356, which you may remember, in the previous 5 years had received notice of 18 heart attacks, 26 strokes, 43 seizures, and 5 deaths. Under the law of the United States of America, Metabolife had no legal responsibility to tell the Government a product it was selling was killing people.

People listen to that and say that cannot be true, but it is. It is a fact.

When a Harris poll surveyed 1,000 Americans about what they thought the law was, they found 59 percent of them said they believe supplements must be approved by a Government agency before they can be sold. They went on to say 68 percent said the Government requires warning labels on a supplement's potential side effects or dangers, and 55 percent said supplement manufacturers cannot make safety claims without solid scientific support.

Sadly, every single response by the overwhelming majority of Americans was plain wrong. There is no Government regulation of the products, there is no requirement for warning labels, and these companies can make safety claims without solid scientific support. That is a fact.

It seems the Institute of Medicine has decided it is time for a change, a change I believe is long overdue. Today the Institute of Medicine released this report. It is a framework for evaluating the safety of dietary supplements. In the fall of 2000, the Food and Drug Administration contracted with the Institute of Medicine to develop a scientific framework for safety evaluation of dietary supplements within the confines of the law. They also asked them to test their framework on six commonly used dietary supplements. The report took more than a year longer to complete than was expected, but it is comprehensive and thorough. It contains many observations we need to scrutinize closely.

First, their framework depends on the collection of data that is not required to be turned over to the FDA by supplement manufacturers, namely adverse event reports.

The IOM report states that the first step in the process for reviewing safety is to look for signals of safety problems, including adverse events. What do I mean by an "adverse event"? Does it mean if you have an upset stomach from a vitamin you have to report it to the Food and Drug Administration? Does it mean if you get dizzy from taking any kind of supplement, from garlic to fish oil, you have to call the Food and Drug Administration? No.

What I believe the standard should be is serious adverse health events. If you pass out, have a stroke, or heart attack, or die-serious things that can occur.

Lest you think this is something that does not happen, let me tell you the story of a young man, 16 years old, who lived a few miles from my home in Springfield, IL. Sean Riggins of Lincoln, IL, a 16-year-old high school student, played on the football team. He had a big game coming up. He went over to the local gas station-gas station, mind you-and saw a product on the shelf called Yellow Jackets. It was an ephedra product. Yellow Jackets were supposed to give him energy. This man thought: I need energy; I am going to play football. He purchased this product over the counter at a gas station in Lincoln, IL, washed it down with a Mountain Dew, which happens to be loaded with caffeine, and started feeling sick. When he got to the football game, he didn't feel good at all. The next day, his mom and dad took him to the hospital, and later that morning he died from a dietary supplement with ephedra. Under the law as it is written, if the parents of Sean Riggins called the company that made Yellow Jackets and said, "Your product just killed my son," that company would not be required under law to even report that to the Government. That is not right.

The Institute of Medicine report we are looking at today recommends that that change. Metabolife misled the Government. Companies that make products such as Yellow Jacket sadly are not much better.

Let me tell you about another company called Rexall Sundown. It marketed an ephedra product called Metab-o-lite described by the Government as having adverse event reports. In other words, people were getting sick who took this product. We heard about it and requested the company provide us with information about the adverse reports, about people getting sick after they took this product.

The response I received was truly astonishing. The company said Rexall Sundown was a new company and had never sold ephedra products. Therefore, it never had any adverse event reports in their possession. They used the oldest trick in the book to shield themselves from liability for the dangerous products they sold. They had dissolved their old company, started a new one with the same name, and tried to escape any liability for the life-threatening products they had been selling. We tried to get more information from them and failed, but we will continue that effort.

Let me also say to people who said, "Thank goodness, ephedra is off the market, so you can stop worrying," that is not the case. The same Consumer Reports magazine that is coming out has a table which I commend to everyone who takes dietary supplements. It is impossible to read this chart, I am sure, on television. I will summarize a few points of it for those who would like to understand what Consumer Reports, an objective magazine, says about 12 supplements. They said you should avoid these supplements.

A supplement that is "definitely hazardous" is aristolochic acid. This is something that is sold under a variety of names. They say it is a potent human carcinogen. It can cause cancer potentially, kidney failure, sometimes requiring transplant. The Food and Drug Administration warned consumers and the industry in April 2001. It has been banned in seven European countries and Egypt, Japan, and Venezuela. But it is still being sold in the United States. Aristolochic acid is also known as birthwort, snakeroot, snakeweed, sangree root, and so forth.

Then they list another group of "very likely hazardous" products banned in other countries where we have a warning from the FDA: Comfrey, which includes blackwort, bruisewort, and so many other herbal names.

Incidentally, let me say at this moment how difficult it is for consumers to follow this because they change the names on these bottles in the dietary supplement store, and you have no idea what you are buying. The Food and Drug Administration advised the industry take it off the market in July 2001, but it is still being sold. It creates abnormal liver function or damage, often irreversible, causing death.

Androstenedione, I mentioned this earlier. The FDA finally banned it in supplements.

Chaparral is another product which is sold under a variety of names. It causes abnormal liver function or damage, often irreversible. FDA warned consumers in December 1992.

Germander is another product banned in France and Germany.

Kava is an ingredient in a variety of products. FDA warned consumers in March 2002 to avoid it. It is banned in Canada, Germany, Singapore, South Africa, and Switzerland, but it can still be sold legally in the United States because the Food and Drug Administration does not have the power and the authority to police this kind of dangerous product.

Under "likely hazardous" products there is one I would like to speak to, bitter orange, citrus aurantium. You will find this in Metabolife Ultra. When they took ephedra out, they put bitter orange in, and there are a lot of other products, diet products, energy products. It can cause high blood pressure and increased risk of heart arythmia.

We wrote to seven companies that make supplements that contain citrus aurantium and asked them: What kind of tests did you engage in to determine whether citrus aurantium, which is now replacing ephedra, is safe? One of the CEOs wrote back and said: We have a scientific study to prove our product is safe. So we looked at the study. The study did not have anything to do with citrus aurantium or bitter orange. It was about the safety of using orange juice-orange juice-in drug metabolism studies.

We then contacted one of the scientists involved in this study and asked: Do you realize this company that is selling thousands of products worth millions of dollars is claiming your scientific study says citrus aurantium is safe?

This scientist came back to us and said: That is an improper use of that study to justify the sale of that product.

So there is no scientific basis for the safety that CEO asserted. These manufacturers are literally putting together dangerous and sometimes lethal combinations of chemicals and selling them under the banner of dietary supplements to unsuspecting American consumers.

For some consumers, it is a waste of money. For others, it is much more dangerous.

There are other products that are mentioned here. I am probably going to fail to pronounce many of them properly: organ/glandular extracts, Lobelia, Pennyroyal oil, Scullcap and Yohimbe. When one goes through these, they will find many of these have been banned in other countries.

One of the conclusions from the Institute of Medicine, after looking at dietary supplements, is unreasonable risk does not mean the Food and Drug Administration has to prove the supplement is harmful.

The report concludes, given the limited amount of data available, definitive statements judging safety of these products may be difficult to completely substantiate scientifically.

The committee determined that concluding a supplement presents an unreasonable risk does not require complete evidence a dietary supplement causes a serious adverse event. In other words, the unreasonable risk standard that is written in the DSHEA law is a standard which frankly is going to be a very difficult one for the FDA or others to prove.

So what they are suggesting at the Institute of Medicine is we look to a different and more reasonable standard. They also talk about premarket review of some of these products, which I think is something that needs to be done.

I particularly believe stimulants should be subject to premarket review so we have some testing to make sure they are safe so many of these products here, such as bitter orange, citrus aurantium, which cause an increase in blood pressure-and, frankly, I believe what they are suggesting in the Institute of Medicine report kind of parallels legislation which I have introduced-to try to bring some sanity to this industry.

This has been a battle which I have been engaged in for almost 2 years now. I know what happens when one takes on a giant industry in America, a multibillion-dollar dietary supplement industry. If one walks into most vitamin stores around America, they will find my name, not in a praiseworthy fashion. They are passing out leaflets saying: Write to DURBIN and tell him to stop taking away your vitamins and minerals.

It is a scare tactic. It is a scare tactic from an industry that should be running scared. There are good actors in this industry and there are bad actors, but unfortunately the bad actors are being protected by the good ones.

Right now I believe Americans should be able to buy vitamins and minerals which have been tested and proven, make their own choices about their own health, but I also believe this industry has a responsibility when it sells products that can be dangerous to Americans to do two things.

First, if they are selling stimulants they should be tested in advance so we do not have another ephedra which is going to take the life of an innocent young boy in Lincoln, IL, or a major league baseball player like Steve Bechler of the Baltimore Orioles.

Second, I believe all of these dietary supplement manufacturers should have a legal obligation to report to the Food and Drug Administration when people get seriously ill or die as a result of taking their products. I think that is the least we should demand.

I am happy to see the Institute of Medicine creating momentum for Congress to finally make a decision. I am happy to see the administration, after more than a year of urging, finally banning ephedra, but more has to be done. Today as we speak, innocent children and consumers across America are buying products which they presume to be safe and they are not.

We have an obligation to American consumers to set a standard of care so they know when they make a purchase, whether it is in a drugstore or in a vitamin store, they are buying a product that is more likely to help them than hurt them. Sadly, the DSHEA law which currently exists does not meet that standard.

I yield the floor, and I suggest the absence of a quorum.