Madam President, I wish to discuss the amendment Senator Roberts and I have worked on, along with Senator Kennedy and Senator Enzi, regarding direct-to-consumer advertising of prescription drugs. I am concerned about the proliferation of…
Madam President, I wish to discuss the amendment Senator Roberts and I have worked on, along with Senator Kennedy and Senator Enzi, regarding direct-to-consumer advertising of prescription drugs. I am concerned about the proliferation of this kind of advertising, its effect on public health and health care spending, how much money we are spending on health care. Senator Roberts and I want to make sure they are done in a responsible way so that consumers have good information and it deals with safety and efficacy. I believe, along with Senator Kennedy and Senator Enzi, we have crafted an amendment that addresses any first amendment concerns, and I believe we
have also crafted an amendment that will help the FDA get better safety and efficacy information to consumers who see these ads.
I wish to take this time to discuss my concerns with direct-to- consumer advertising of prescription drugs. Keep in mind, we are talking about ads you see on television, you hear on the radio, you see in newspapers and magazines for drugs that you cannot buy unless you get a prescription. It raises all kinds of questions. Why would you advertise drugs that you can't buy? I can see advertising Advil or Tylenol or a host of other over-the-counter-type drugs that you can go into a drugstore and buy, such as cold pills and antihistamines. But for prescription drugs, it raises an interesting question: Why would these drug companies be spending so much money advertising directly to you if you can't even buy it unless you get a prescription?
Let's look at the history of what has happened. Information that is conveyed in these ads is supposed to balance risks and benefits of a specific drug and provide information to the public. But what we have seen happening over the last several years is less and less information and more and more promotion--ads that minimize the risks associated with the drugs and maximize the benefits. They are not balanced. As a result, in exchange for an increased market share for a drug company, the consumer is left with an incomplete and even a dangerous understanding of a drug's risks and benefits.
More often than not, these ads do not provide consumers with accurate comparisons between new drugs or even older drugs that are still effective.
For example, in a 2002 FDA survey of physicians, 65 percent of physicians thought patients were confused by the relative risks and benefits of drugs they saw advertised; 75 percent of the doctors believed the ads led patients to overestimate the efficacy of advertised drugs. All of this can only lead to one conclusion, that there is not a fair balance of risks and benefits in these ads.
Worse still, 86 percent of physicians had a patient who asked about a specific drug. They didn't ask about something for their back pain or for allergies, they asked about a specific drug. Eighty-six percent of physicians said the patients asked about specific drugs. As it turns out, the patient usually got that drug.
Seventy-seven percent of primary care physicians prescribed a drug a patient asked for; 74 percent of specialists did.
Let's look at some of these drugs and what happened. We all know what happened when Vioxx, a pain reliever now associated with heart attacks, was pulled from the market after being heavily marketed to consumers. Consumers never had a clear picture of the risks and benefits associated with the drug. Millions of consumers were put at risk.
One wonders how many doctors said to a patient who came in: You know, if Advil works for you now, you probably don't need Vioxx.
Look what happened with Vioxx: 2 million Americans took it. It was marketed in 80 countries. Madam President, $100 million per year was spent on direct-to-consumer advertising of the prescription drug Vioxx over about 5 years. So about a half billion dollars was spent to tell you Vioxx was good for you.
What happened? Because of all this heavy advertising, there was $2.3 billion in sales in 2003. We all know what happened. It was pulled from the market in 2004. Why? Because thousands of people died of heart attacks because they took Vioxx. Yet this product was subject to heavy direct-to-consumer advertising.
We all remember the Vioxx ads, how good it was for you. Then we find out it was causing heart attacks. Again, this is a clear indication of the irresponsibility of these drug companies in direct-to-consumer advertising. It has just gotten out of hand. It has totally gotten out of hand.
I will show on the next chart what I mean by getting out of hand. Here is the spending on direct-to-consumer advertising. Keep in mind, prior to 1996, we didn't have direct-to-consumer advertising very much on TV and radio. Pharmaceutical companies basically marketed to doctors. You went into the doctor's office. You saw things in the doctor's office. But the doctors were the ones who got the advertisements.
In 1997, the FDA promulgated some rules which opened up the system. Then, all of a sudden, the drug companies started marketing to consumers. In the first year, they spent $791 million. Look what has happened every year. More and more and more. In 2003, $3.2 billion was spent on advertising. I made the chart before I got the latest figures, but today I got the 2005 figures. It is now $4.2 billion. Madam President, $4.2 billion was spent in 2005 advertising drugs you can't buy unless you get a prescription. Keep in mind, these are drugs for which you have to have a prescription. So it has gotten out of hand.
To make matters even worse, most of this money that is spent, $4.2 billion in 2005, was for the promotion of only 50 brand-name drugs. As a GAO study found out, these drugs are most often for chronic conditions, not for cancer--not for life-threatening diseases--but for chronic conditions. GAO found the ads tend to be for antihistamines, sleep aids, acid reflux, and--as we all know too well from watching evening television--things like impotence. We all know this is true. We know it. Look at the ads on TV every night.
It is no coincidence these advertisements are for drugs that you must take repeatedly. It is so you will get hooked on a brand and then you have to keep taking it and taking it and taking it.
I will yield.
The GAO did this study which found that 86 percent of physicians responded that patients came in to ask about a specific drug--the purple pill, the green pill. You might say: Why are the doctors doing it? One doctor said to me: You are right. They shouldn't be advertising this. Patients coming in would be just as well served by taking an aspirin or something like that, very cheap and readily available, and I tell them that. The doctor is telling me this. I tell them that, and they
say, no, no, they saw this ad. They want this. I tell them no, but they say: Well, Doctor, if it is all the same with you, I would just as soon have that pill. So he says: Well, if you want it, I will prescribe it.
So there is an undue amount of pressure being put on doctors right now to prescribe these drugs because patients are demanding it.
Well, I thank the Senator for his great leadership in all these areas on drugs, on reimportation, which I was proud to support him on. We have to get a handle on this.
We all have first amendment concerns. People have the right to advertise, but I question whether they can advertise in a way, like with Vioxx, where they tell you all the benefits, but they do not tell you the risks, or they put them in such little fine print that it takes a 50-power magnifying glass to read them.
On television, how many of you have seen the ads where they come on with this wonderful advertisement of a drug, and then in the end it says: Not to be taken by, and it goes so fast you can't understand what they are saying. It is akin to listening to an auctioneer. You can't understand what they are saying. So you see all the benefits of it, but you don't get any of the downsides.
One might ask: Why are companies doing it? Well, simple. They make money. The Kaiser Family Foundation found an additional $4.20 in savings for every dollar spent on advertising. There you go. If you could spend a dollar and make $4.20, who wouldn't?
So we have to ask some questions. What happens when we create an artificial demand? What is the effect on our budget? Some people might say: Well, that is OK, but people are spending their own money or the insurance company is. That is not so. Think of all the money we are spending on Medicare and Medicaid for these drugs that people are being beaten over the head with every day on these ads on television. Think about the baby boomers retiring.
I said that by 2005 the spending had gone to $4.2 billion. Think of what it is going to be this year. I will bet it will be over $5 billion this year, spent on advertising alone, for drugs you can't buy unless you get a prescription. So it is clear to me it has very little to do with patient care and very much to do with making money. I don't mind drug companies making money. That is fine. They do good things. They invest money in research--not as much as I wish they would--and they come up with good drugs. We all take them when we get sick or when we have a disease. The problem is it has gotten out of hand.
It was OK when they did a little bit of advertising, but now it has gotten out of hand. It has gotten to the point now where an individual from a drug company--I will not mention who--said to me: Well, yes, you want to turn the clock back to 1996, when we didn't advertise much on TV. He said: That would be nice, but you could never get it done because not everyone would agree. Because, you see, the big drug companies, the big ones that have some major portion of these 50 drugs that are basically the ones being advertised, they have got the power. The little drug companies out there, which may have good drugs for you, lifesaving drugs and things such as that, they have to get in the game too. They have to compete. So it keeps ratcheting itself up every year. Every year it ratchets itself up with more and more advertising.
Before I yield the floor, I wish to review a little bit the history, so we are clear on how we got to this point. In 1962, Congress gave the FDA the authority to regulate prescription drug advertising which, at that point, in 1962, consisted of ads in medical journals. Regulations followed from the FDA, after 1962, which required that all drug ads include ``a brief summary statement that discloses all the drug's known risks.'' That was done, and all the medical journals, whenever the drug company would put an ad in a medical journal about the benefits of the drug, they had to include, and they did include--they were very responsible for a long time--all the known risks. After all, they were advertising to doctors, people who were knowledgeable in the field.
Until 1997, there was no real guidance beyond that as to what was required. Today, based on guidance that was finalized in 1999, an ad sponsor is only required to disclose ``the most important risks'' in a ``major statement'' in the audio portion of a TV or radio ad. The FDA does not require that all risks be read in the ad.
Think about that. You can tout all the wonderful benefits, but you don't have to tell what all the risks are. The FDA requires that an ad sponsor provide other places to find the list of all the risks. So you could have an ad on TV tell you Vioxx is great--there may be a problem with irregular heartbeat, maybe--but if you want to know all the known risks, you can call this toll-free number or you can go to a health care provider and ask your doctor or print ads.
As I said earlier, it can be very easy for a statement about risks and benefits to get lost in the creative content of the ads. It is no wonder consumers demand newer drugs from their doctors. They don't have a clear idea of the true safety or the efficacy profile. Over time, it has become clear that sometimes the creative content of the drug ads has the effect of minimizing the safety profile of a drug while artificially spurring the demand.
I have one other chart I wish to show. This ad right here. Here is an ad for Cialis. If you have ever watched television in the evening in the last several months, you have seen this ad. You could have seen it in the last few weeks. It seems like I can't turn on the TV that I don't see this ad, so I put it on a chart in case someone might have missed it. It is talking about Cialis. It has this wonderful scene at the end, with a woman in a bathtub, a man in a bathtub, and a beautiful valley scene--maybe Napa Valley, I don't know where it is--and they say: If a relaxing moment turns into the right moment, will you be ready?
While this is on the screen and you are looking at this beautiful scene and thinking how wonderful it is, they come on and give you a couple of known risks. Are you going to listen to that? Or are you paying attention to how wonderful Cialis is for you?
This is another example of the amount of money being put into advertising. This is not a drug preventing a disease someone might have. It is not for a life-threatening disease or anything like that. Not at all. Yet that is where the money is going. That is what the problem is with a lot of these ads.
What our amendment does is it tries to fix some of these problems and to help the FDA and the companies to provide better information so that consumers can make real choices, not a choice based on a movie endorsement or a slick advertisement. So our amendment does four things:
First, the 2-year moratorium on direct-to-consumer advertisements found in the underlying bill is dropped. While I believe this provision is constitutional, I understand and respect the concerns others have on this point.
Secondly, in the underlying bill, every ad may be prereviewed by the FDA. In this amendment, as part of that process, the FDA may require specific safety information in the content of an advertisement as part of a risk evaluation and mitigation strategy. In addition, the company must include any changes the FDA requests about a serious risk in the content of the ad or they are subject to civil penalties.
Third, civil monetary penalties can be assessed against a company for an ad that is false and misleading in the way it presents its safety and efficacy information.
Fourth, the major statement relating to side effects, contraindications, and effectiveness that is included in every TV and radio ad must now be stated--and get this--in a clear, conspicuous, and neutral manner. A clear, conspicuous, and neutral manner.
Hopefully, this will clarify the major statement about risk and benefits, which is paramount, and that the creative wonderful scenery will not distract from it. I think it is a good compromise. It is a step in the right direction. Hopefully, we will get the bill through, this will be a part of it, and we will see if the drug companies want to be responsible.
We don't need to spend $5 billion a year advertising for drugs for which you have to get a prescription. I would rather they put that money into research, research on drugs that really are lifesaving and helpful to more people.
I hope this amendment will be accepted. As I said, it is a compromise, obviously. It is not everything I wanted to do, but I think, again, it is a step in the right direction, and it will give us a yardstick. If, a couple of years from now, we see that the spending has gone from $4.2 billion to $5 billion to $5.5 billion to $6 billion, then we will really have to come back here and tighten down on it even more.
This is a shot across the bow to the drug companies--rein it in, be responsible, or tougher things are coming in the future. So it is really up to the drug companies to now start to be responsible. It is up to FDA to use their authority to make sure the contraindications, the safety measures, the drug interactions--all the things that may happen to people--are presented in a clear, conspicuous, and balanced and fair manner. That is the essence of the amendment. I hope it will be adopted.
I yield the floor.