[Congressional Record (Bound Edition), Volume 151 (2005), Part 11]
[Senate]
[Pages 15265-15268]
[From the U.S. Government Publishing Office, www.gpo.gov]




              CONCERNS ABOUT PRESCRIPTION DRUG ADVERTISING

  Mr. FRIST. Mr. President, I would like to make a statement that I 
regard as a very important one because it reflects what I think is a 
needed change in behavior that affects health care across America. Let 
me begin with a few phrases: ``Keep the spark alive,'' ``The healing 
purple pill,'' ``If a playful moment turns into the right moment you 
can be ready,'' ``For everyday victories.''
  You turn on your TV anytime of the day and that is what you will hear 
and that is what you will see. These are the advertising tag lines for 
some of America's best selling and most advertised prescription drugs--
in the last several weeks, months and years. We all know them when I 
read them. Some even have the images that pop up into their minds, 
because we see them again and again and again and again. We are 
barraged by them.
  I mention this as a physician, because 10 years ago you would not 
have seen any of that advertising on television. We have heard them on 
our television sets, we hear them on our favorite radio programs, we 
see them in newspapers, we see them in magazines. Those who go to 
NASCAR races see them on the cars. You see them on billboards along the 
highways. We are barraged with this information. It is called direct-
to-consumer advertising. When I was practicing medicine before coming 
to this body--not that long ago, in 1994--it didn't exist.
  This is what direct-to-consumer advertising is. When drug companies, 
pharmaceutical companies, market their products, the marketing used to 
be done to physicians who could accumulate that information and help 
patients make decisions. But the direct-to-consumer goes over the heads 
of physicians with this advertising, direct to the American people, 
direct to the consumer. It is called direct-to-consumer advertising, or 
DTC is the terminology people use.
  It is a two-edged sword. Obviously there can be huge health education 
benefits to such advertising because you are exposed to it, you are 
barraged with it, and information is provided, information to which you 
might not otherwise have access. But let there be no mistake, drug 
advertisements are fuel to America's skyrocketing prescription drug 
cost. It is a two-edged sword. The advertising is new over the last 10 
years. Now it is time to assess the efficacy of advertising, but also 
potential damage that is done by this proliferation, this skyrocketing 
of advertising to which we are being exposed.
  These ads do influence consumer behavior; otherwise, drug companies

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wouldn't be putting money into them. Their real purpose at the end of 
the day is to have a drug that, yes, helps people, but also makes money 
for them. It affects consumer behavior and it also--though it is not 
said very much but I will speak to it here shortly--affects physician 
behavior in a way I think is detrimental. Physicians don't want to talk 
about it very much because it is a little embarrassing. I will come 
back to that. But it affects physicians' behavior in a way that I think 
is not healthy, as well as affecting consumer behavior.
  These ads cause people to take more prescription drugs. They have the 
potential to create an artificial demand and thereby they can drive up 
health care costs for everybody listening to me as individuals, but 
also our overall health care cost for the Nation.
  I believe it has reached a point where they--again, it can be very 
positive with the health education--are needlessly and wastefully 
driving up health care costs. Thus it is time for us to get more 
information but also address the issue.
  Moreover, a lot of the direct-to-consumer advertising is misleading. 
I know, as people listen, you tend to believe, unfortunately, what you 
see on TV and that can be dangerous in certain cases. This direct-to-
consumer advertising can oversell hope, and people want hope; it can 
oversell results; and it can also undersell the risk. Every drug has 
side effects. Every drug has a side effect. We may not know all of the 
side effects, but the idea of promoting a drug without adequately 
enumerating, spelling out, highlighting the risk is wrong. Misleading 
advertising, especially when we are barraged with it, when that is all 
we see--a little bit of hyperbole, on TV between shows, if it is 
misleading, hurts patients and definitely pressures doctors to 
overprescribe or to change prescribing habits in response to that 
request, that specific request from a patient.
  So today I rise to urge all pharmaceutical companies to voluntarily 
restrict consumer drug advertising during the first 2 years that a new 
drug is on the market. Today I am also requesting a Government study 
into the cost and into the consequences and any potential benefits of 
direct-to-consumer advertising. It is time for the drug companies, I 
believe, when it comes to direct-to-consumer advertising, to clean up 
their act. If they do not, I believe Congress will need to act in this 
arena.
  In its proper place, direct-to-consumer drug advertising gives 
patients, gives consumers, information. It empowers them to make 
decisions. It can give them the information they need in order to make 
informed decisions about their health, about the advantages of a 
particular drug. It can instruct them and open their eyes to symptoms 
they have that might be very serious but they might not otherwise go to 
see a doctor about. It can inform them about new therapies, the 
breakthrough therapies that are so powerful--made in large part because 
of the research and development in our private sector by our 
pharmaceutical companies.
  These are good things. These are the good things that advertising can 
do, that education can do, that knowledge can do. Indeed, I envision a 
health care system--and we are not yet there today, but I think we are 
moving in that direction, in part through legislation on the floor of 
the Senate, to move to a system that is centered not on big Government 
and not on us micromanaging from the floor of the Senate prices and 
decisions, but, no, move toward a system that is patient centered. We 
are moving toward a health care system that centers on the individual 
patient, that is provider friendly, and that is driven by three things. 
Those are knowledge or information that is given the patient, the 
individual, the opportunity to choose and make choices for themselves, 
and to make sure that patient is empowered, they have resources to make 
those decisions.
  So if you are looking at a consumer-driven, patient-centered health 
care system, having timely information, accurate information, complete 
information, and balanced information has to be one of the major 
pillars.
  Direct consumer advertising can be very helpful in that regard if 
that is the purpose and if it meets those standards. I don't think the 
advertising we see today--and I base this on people coming up to me all 
the time as a physician and policymaker--I don't think the advertising 
today meets those standards. I will have more to say about that issue.
  With today's advertising, perhaps you are at a ball game with your 
family, going to a movie or to dinner--ask somebody about it--and 
today's advertising will likely leave parents having to explain to 
their young children, their 10-, 9-, 8-year-old, what erectile 
dysfunction is rather than a discussion of the importance of getting 
your blood pressure checked to see if you have hypertension so you will 
not have a stroke or heart disease. That would be useful information.
  That is the problem. How did we get to this point? Prior to the 
1980s, drug manufacturers almost always introduced and explained their 
products to physicians. Physicians had a body of knowledge and the 
training to make an assessment of whether, based on the information the 
drug companies gave them, this would be an efficacious drug, a useful 
drug to use, or whether the side effects would be appropriate for 
individual patients.
  In 1981, just over 20 years ago, Boots Pharmaceuticals ran the first 
U.S. print advertisement--just 24 years ago. It was directed to 
consumers for the ibuprofen product brufen. In 1980, print advertising 
picked up. In the 1990s, drug companies began to use more print 
advertisements to promote their products--again, directly to consumers, 
not going through physicians--and during that period they ran 
television advertisements sparingly. Rarely would consumers turn on the 
television and actually see an advertisement directed at the consumer 
on a drug.
  Looking back over the last 40 years since 1962, the FDA has had a 
requirement--the FDA is the Government institution in charge of 
regulation and oversight. Since 1962, the FDA has required ads to 
include a brief summary of a drug's side effects, indications for use, 
the contraindications, the warnings and precautions.
  Regarding the massive changes we are exposed to today, look back to 
the Clinton administration in 1997 when the disclosure rules for 
television ads were liberalized. The door was opened. That is not that 
long ago--3 years after I formally left the practice of medicine to 
come to the Senate. Rather than providing a full picture of a drug's 
risk and benefits, the new laws required only that drug companies 
disclose the most significant risk and then refer patients to a 
secondary source of information, leaving this whole inadequacy of the 
risk and adverse effects on the ad as presented.
  As a direct result of this 1997 ruling, spending on direct consumer 
advertising skyrocketed 145 percent between 1997 and 2001. It passed 
the $1 billion mark in 1997. It was almost nonexistent 7 years before 
that and skyrocketed to about $1 billion in 1997. Then 4 years later, 
it kept skyrocketing and reached $2.7 billion. Indeed, last year, the 
drug companies spent over $4 billion advertising medications directly 
to consumers.
  This 145 percent over that 4-year period from 1997 to 2001 for direct 
consumer advertising, reaching consumers, should be compared to an 
increase of only 59 percent for research and development for drugs--
clearly, a heavy investment in direct consumer advertising. Why? 
Because that advertising increases utilization of that drug and sells 
more drugs.
  The Clinton administration at the time they opened this door--under 
intense pressure by the drug industry--not only opened the door but 
opened the door too widely, and our regulatory body has not kept up 
with what has come through that door. As a result, the direct-to-
consumer advertising exploded to levels that at least I did not 
anticipate. As we watched this unfold through the 1990s, I don't think 
anyone anticipated the level that we see when we turn on the television 
today. That drives up drug use, that drives up drug

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spending, and, of course, that will drive up the cost of health care 
generally.
  In addition to all that, it has led to inappropriate doctor-physician 
prescribing. We have to be careful because until we really study it, we 
will not know all effects. My doctor friends tell me again and again, 
when a patient comes in with a specific request for a drug written down 
and the doctor has 30 or 40 patients waiting outside, it is almost 
easier--I am embarrassed to say this--almost easier for a doctor to 
write the prescription and give it to them even though there may be a 
generic drug or a much less expensive drug. The patient comes in and 
says: I have to have this drug. This drug is what I have in mind, the 
hope for the cure for my disease.
  This misallocation of resources and inefficiency that results from 
inappropriate prescribing from the physician's standpoint is something 
we can rip out of the system if we turn to a balance between very good 
and direct-to-consumer advertising, which includes patient education, 
but get rid of the inappropriate, imbalanced state we are in today.
  If we consider the recent labeling changes in market withdrawals of 
just one class of drugs, the nonsteroidal anti-inflammatory, it tells a 
story. These drugs were the most heavily advertised in America. They 
were used by millions and millions of patients. Millions of patients 
benefited, I should say, from these drugs, but many people today 
believe--looking back at what happened in response to the advertising--
that they were overprescribed.
  In the case of one drug people have heard a lot about, Vioxx, 93 
million prescriptions had been written since its approval in May 1999. 
Millions of prescriptions were also written for similar drugs such as 
Celebrex and Bextra. In the case of Vioxx, indeed, it was a better 
drug. It did prove to be better than competing products for patients 
who had gastrointestinal problems or stomach problems. America did 
conduct postmarket research that was not required by the Food and Drug 
Administration. Of course, we cannot foresee every risk. It does take 
time to accumulate information to fully assess risk.
  Quite simply, we should always strive to make safety the top concern, 
not selling the most drugs through increasing utilization, through 
advertising, but ultimately to make safety our top concern, especially 
for newly approved products that are used for the very first time in 
millions and millions of patients. It takes time for the adverse 
reactions and side effects to be fully explored and to fully surface. 
Doctors should have more time to use the drugs to gain experience with 
them, to collect more balanced information, and to be able to weigh the 
risks and benefits of a product.
  In a 2002 report on the practice, the Government Accountability 
Office, the GAO, highlighted two studies. The last time it has been 
studied--and that is why I want to study it now, because we have had 
this explosion--but in the two studies they highlighted in 2002, the 
last report, each showed a 10-percent increase in direct-to-consumer 
spending within a drug class increased sales in that class by 1 
percent. For one popular, very heavily advertised prescription drug, $1 
of consumer advertising translated into $4 in increased sales--$1 
dollar in advertising, $4 in sales. So we see the motivation from the 
drug companies in advertising particular drugs. It is no wonder the 
drug companies are flooding our airwaves today.
  The GAO findings in that 2002 report were clear: Increased direct-to-
consumer advertising has helped fuel escalating drug costs. These drug 
costs, as we know, are skyrocketing. In 2003, Americans consumed 134 
billion prescription pills and spent over $216 billion on prescription 
drugs. That is as much as Americans spent on gasoline and oil. During 
the past few years, drug costs have gone up more than twice as fast as 
inflation, faster than nearly all other health care items and services.
  Congress has paid attention to these skyrocketing, escalating drug 
costs, and we have acted on the 2003 Medicare Modernization Act. We 
took major steps toward providing more affordable prescription drugs. I 
add the ``more affordable'' because we did a number of things.
  First and foremost, recognizing the importance of prescription drugs, 
centrality of prescription drugs to health care delivery today, we 
provided seniors with an outpatient prescription drug benefit under the 
Medicare Program for the first time in history--something I feel 
strongly about, something I am very excited about as we look over the 
next year, couple of years, where implementation begins. We also 
established health savings accounts that allow individuals to own and 
take care of their own health care. We reformed patent laws and closed 
loopholes to help speed lower cost generic drugs to market and set 
standards to encourage more efficient electronic prescribing and 
improved patient safety. We provided funds to the Department of Health 
and Human Services to study the clinical comparative effectiveness of 
drugs and then take that information and share it with patients, to 
share it with consumers so they can make prudent decisions.
  We have taken some good steps, moved in the right direction, but we 
clearly have a lot more to do. Part of this effort, and the reason I 
bring it to the Senate today, is a responsibility we have to look at 
prescription drug advertising. Unbalanced and misleading prescription 
drug advertising hurts the American people. We will look at it. It adds 
tension to the relationship between doctors and patients, the 
physician-patient relationship. It can lead to inappropriate 
prescribing, and it can overwhelm our current regulatory system.
  As consumers, we are all familiar with these ads. They adorn major 
magazines, Web sites, newspapers, and flood the airwaves. Particularly 
on television, they present upbeat images, a parade of images that 
bring hope and beauty with these positive images, but often the warning 
and the cautions are in either fine print or as an afterthought. As I 
mentioned earlier, think how many parents have found themselves 
watching a sporting event with their son or daughter, only to be 
assaulted by an ad for erectile dysfunction.
  Think back to advertising during this year's Super Bowl, the nature 
of those ads and the focus of those ads. Only rarely do these ads 
provide consumers with enough time to absorb the risk information. In a 
2002 FDA study, nearly 60 percent of patients reported drug 
advertisements did not provide enough risk information. In that study, 
58 percent of patients felt these ads portrayed products as better than 
they are. In another 2002 FDA survey, 75 percent of physicians said ads 
led patients to overestimate the efficacy of the drugs, and 65 percent 
of physicians noted that patients confused the risk and benefits of 
drugs advertised to consumers.
  What this means is sometimes a patient may request a drug, even 
insist upon a drug, even if it does more harm than good. They may too 
heavily rely on a pill when an overall lifestyle change might be more 
appropriate. They may come in and demand the latest, most expensive 
medication when an old standby could do just as well.
  Patients seeing the ads place new demands on their doctors. As I 
mentioned, when my medical colleagues are pressed for time, they tend 
to respond with the easy way of responding to a specific demand--even 
if it might not be either the most cost-effective or efficacious drug.
  Thinking of one example, after one year of directly advertising the 
bone-mass-increasing drug Fosamax to consumers, physician visits for 
osteoporosis evaluation nearly doubled. That in some ways may be good 
because it shows the double-edged sword in that people go to the doctor 
and they ask appropriate questions. But then you have to ask the 
question: Did these ads provide the patients with the appropriate 
information to go see that doctor for the appropriate information on 
the side effects of that particular drug?
  An interesting study from the University of California-Davis was 
where the researchers sent actors in good

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health to 152 doctors' offices in three cities to find out if they 
could get prescriptions for simulated symptoms. Half of the actors 
imitated patients suffering depression. The other half expressed 
symptoms of stress and fatigue.
  The study found that if an actor requested Paxil, which is a heavily 
promoted antidepressant, he was five times as likely to walk out of the 
doctor's office with a prescription for the drug. The research 
suggested that direct-to-consumer advertising increases patient demand 
for specific medications, even in situations where prescriptions are 
not needed.
  Finally, we need to ask questions about how we regulate this drug 
advertising. Right now, the Food and Drug Administration simply has 
neither the resources to scrutinize direct-to-consumer advertisements 
nor the power to review them for accuracy before they are viewed by the 
public. In 2002, the FDA received over 137,000 pieces of promotional 
material for review. Some of these materials appeared on the airwaves 
or in print even before they arrived at the office of the FDA.
  The entire division responsible for this oversight consists of 40 
employees--just 40 employees--who have to review almost 40,000 complex, 
medically sensitive advertisements. It is not enough. The FDA knows it 
is not enough. We have not given them enough resources.
  Two years ago, Dr. Janet Woodcock, then the FDA's Acting Deputy 
Commissioner for Operations, told the Senate Committee on Aging:

       It would be impossible for the FDA to try to track the 
     number of different broadcast advertisements that are aired.

  Almost unbelievable to me is the fact that the FDA review comes after 
the fact. It cannot require drug companies to submit their 
advertisements before they appear on the airwaves or on the Internet or 
in print. The FDA simply cannot keep up.
  Our failure, our Government's failure, to appropriately regulate drug 
advertising hurts the very people I believe the drugs are intended to 
help, and that is the patients. We are not serving the American people 
as well as we should.
  Mr. President, 2 weeks ago, the pharmaceutical company Bristol-Myers 
Squibb announced a voluntary ban on advertising its new drugs to 
consumers in their first year on the market. The company said it wanted 
to give doctors more time to understand new products before patients 
start asking for them. I think this shows leadership. It shows 
responsibility. Bristol-Myers is setting an example in showing 
restraint in the industry.
  I know PhRMA--that is the drug industry's trade association--has 
announced it will adopt an industrywide voluntary code governing 
direct-to-consumer advertising next month--another good move.
  Mr. President, what should we do? I believe, at a minimum, the 
pharmaceutical industry should include a voluntary restriction on the 
direct-to-consumer advertising of prescription drugs in their first 2 
years on the market. This restraint is important because a typical 
clinical trial for a drug includes about 5,000 patients. A blockbuster 
drug can attract as many as a million patients in the first year on the 
market. But since no drug is free of a side effect, we may not fully 
know what those side effects are. Doctors and patients need time to 
learn about the new treatments to be able to assess their benefits and 
find out more about the risk. Education should come before persuasion. 
Patient safety should be paramount, not the bottom line.
  So what should we do? Three things.
  First, we should give the FDA prior review and approval authority for 
all direct-to-consumer drug advertising. By the time the FDA reprimands 
a company for running a misleading drug commercial, that advertisement 
may have already deceived consumers. Advertising should boldly and 
responsibly address safety head on, replacing the upbeat fantasyland 
images with a frank discussion of a product's risks and benefits.
  Second, we should increase resources devoted to reviewing 
advertising, to determine the advertisement's accuracy and to ensure 
all standards are met.
  The FDA must have the resources, must have the capability to more 
thoroughly monitor drug advertising and make sure that companies fully 
comply with the advertising guidelines.
  The American people assume this is being done today when they see 
those ads, and it is not. A staff of 40 is simply not sufficient.
  And third, we should give doctors and patients greater access to 
clinical data and postmarketing surveillance efforts about drugs after 
they become available.
  For the drug industry, which has long touted the educational benefits 
of its advertising and of its mission, it has to know that the success 
of their mission inherently depends upon the quality of information 
they give to physicians and patients--not just the enticing images, but 
the quality of information.
  Mr. President, in closing, as a doctor who has witnessed both the 
good but also the bad in this explosion of drug advertising direct to 
the consumer, I feel I have a responsibility to watch this issue 
closely. If the pharmaceutical industry's voluntary restrictions are 
not strong enough, I will support congressional action to make sure 
consumers get the protection they deserve.
  In the meantime, today, I am asking the Government Accountability 
Office, the GAO, to investigate FDA's oversight of prescription drug 
advertising, the pharmaceutical industry's spending on such 
advertising, and this advertising's impact on utilization, health care 
spending, and patient education and awareness.
  Wherever I go--whether it is to meet with a group of doctors at a 
medical meeting at the Harvard Medical School or back at the University 
of Tennessee or at the Coca-Cola 600 in Charlotte--people come to me 
and say the direct-to-consumer advertising has gone overboard.
  We have to return balance. I believe we can and we should move into a 
health care system that is centered on the patient, where they have 
appropriate information to make decisions-- a consumer-driven, 
provider-friendly, patient-centered system.
  I know my colleagues share these or similar priorities. I believe the 
steps I have proposed today will be to the benefit of patients. It will 
save money. It will save lives. Prescription drugs, I believe, are the 
most powerful tools in American medicine today. We really could not and 
should not do without them. But we have to use them and market them and 
promote them with care.
  Mr. President, I yield the floor.

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