[Congressional Record (Bound Edition), Volume 146 (2000), Part 8]
[Extensions of Remarks]
[Pages 11147-11148]
[From the U.S. Government Publishing Office, www.gpo.gov]


[[Page 11147]]

INTRODUCTION OF THE FAIR BALANCE PRESCRIPTION DRUG ADVERTISEMENT ACT OF 
                                  2000

                                 ______
                                 

                        HON. FORTNEY PETE STARK

                             of california

                    in the house of representatives

                        Thursday, June 15, 2000

  Mr. STARK. Mr. Speaker, I rise today to introduce the Fair Balance 
Prescription Drug Advertisement Act, a bill to deny tax deductions for 
unbalanced direct-to-consumer (DTC) pharmaceutical advertising placing 
more emphasis on product benefits than risks or failing to meet Federal 
Food, Drug and Cosmetic Act requirements.
  This bill will ensure that prescription drug advertisements provide 
the public with balanced information concerning product risks and 
benefits. For example, the bill requires that pharmaceutical ads 
utilize equivalent space and type size in print ads and equal air time 
in broadcast media--such as television, radio and telephone 
communication systems--for risks and benefit descriptions. Today, most 
drug advertising emphasizes product advantages while failing to 
clearly--if at all--explain often numerous potential disadvantages.
  By denying any tax deduction for such advertising, this bill will 
encourage drug companies to halt these harmful practices that have been 
shown to increase health care expenditures, mislead the public, 
adversely affect physician prescribing practices and lead to 
unnecessary injuries and deaths. Responsibilities of the FDA and 
Treasury Departments are to be clearly delineated through regulation.
  Since the FDA loosened its DTC advertising requirements in 1997, drug 
companies have doubled their advertising budgets and spent billions 
extolling the benefits of their products. DTC advertising increased 
nearly 20-fold during the 1990s. Last year, drug companies spent nearly 
$2 billion advertising to consumers, with $1.1 billion for television 
ads alone.
  As one would expect, such advertising has a direct impact on drug 
expenditures. DTC advertising leads to more physician office visits, 
increased patient requests for expensive, brand name drugs--even where 
a generic drug is available--and over-prescribing of optional 
``lifestyle'' drugs. Americans spent more than $100 billion on 
prescription medicines last year--i.e., about 10 cents in every health 
care dollar. U.S. sales for the antihistamine Claritin, No. 1 in DTC 
advertising, were $2.3 billion last year, while the well-advertised 
heartburn medication, Prilosec, brought-in $3.8 billion in sales. Not 
surprisingly, drug spending increased at a rate of about 15%-18% last 
year and is on the rise.
  Contributing to overall increased expenditures, drug prices continue 
to soar. On average, prices for the 50 most-prescribed drugs for senior 
citizens increased at twice the rate of inflation over the past six 
years--with some drug prices increasing at four times the rate of 
inflation. Business Week reports that the hikes in drug prices are not 
only tied to new ``wonder pills,'' but also to the drug industry's 
bloated advertising budget.
  Such spending is particularly troublesome since consumers receive 
inadequate information about the drugs they purchase. More and more 
commonly, both television and print ads have become the subject of 
ridicule due to their inaudible or illegible short list of warnings. A 
recent cartoon in the Washington Post mocked the typical concluding 
remarks of a prescription drug TV ad: ``WARNING: This drug commercial 
will be followed by a disclaimer that may cause nausea, disgust, and 
serious doubts.'' A typical Washington Post newspaper ad for Prilosec 
highlights the drug benefits on a full-page, large print, color ad, and 
includes a prominent $10 rebate offer. Yet the most important drug 
information--warnings, contraindications, indications, usage, 
precautions and adverse reactions--appear on the next page of the 
paper, separated by two, full columns of World News and in type size 
that is almost too small to be read by the naked eye. Unfortunately, 
such advertising has become the norm.
  Although the Federal Food, Drug and Cosmetic Act and the Food and 
Drug Administration (FDA) regulations and guidelines currently regulate 
drug advertisements, pharmaceutical ads most often fail to provide the 
public with adequate information about potentially dangerous drug side 
effects. RxHealthValue is a new, independent group, representing more 
than 30 consumer groups, private employers, purchasers, health care 
providers, labor unions and academics. Last month, this organization 
recommended that the FDA ``develop standards for full disclosure of 
drug risks and benefits information for all prescription drugs 
advertised directly to consumers.'' The group also called for 
specifying that ``fair balance'' means that full disclosure of risks 
and side effects is given equal print or air time as the description of 
benefits in the same communication.
  I would also like to insert in the Record a May 3, 2000 USA Today 
article providing further evidence of the need for adequate information 
about drug risks. According to the article, less than 1% of physicians 
have seen a drug label in the last year. And ``in many cases, patients 
never even see the package insert, and when they do, the tiny typeface 
and medical jargon often leave them more confused than ever.'' These 
inserts are jam-packed with important warnings and most often go 
unnoticed. The article reports that drug labels are complex and fail to 
provide patients and doctors with critical information. Consequently, 
many patients and doctors fail to read drug labels, leading to 
inappropriate prescribing, illness and even death.
  The article also cites the recent withdrawals of Rezulin, Posicor, 
Duract and the anticipated removal of Propulsid as evidence that both 
patients and physicians are unaware of critical drug information. The 
FDA noted that after altering Rezulin's label to recommend monthly 
liver function tests, less than 10% of patients had the tests. And 85% 
of the 270 Propulsid-related adverse side-effects reported to the FDA 
(including 70 deaths) occurred in patients with risk factors already 
listed on the drug's label. Similarly, all but one of the 12 cases of 
adverse events (including four deaths) occurred among patients who took 
the drug for longer than the recommended ten days.
  Adding importance to the need to provide accurate, balanced 
advertising is the fact that the news media often misses the facts. 
According to a study featured in this month's issue of the New England 
Journal of Medicine (NEJM), newspaper and television medical reporting 
is often inadequate or incomplete. The NEJM found that the media often 
lacks or omits critical information about drug risks, overstates the 
benefits, cites medical experts without mentioning their affiliation 
with the drug industry, and fails to provide adequate information about 
drugs in general. The analysis of 207 recent news stories revealed more 
than half as completely silent about drug risks or side effects. It is 
clear both patients and medical professionals need comprehensive drug 
warning information.
  In the event that any drug company claims that changes in tax 
treatment will directly decrease their investment in research and/or 
lead to higher drug prices for consumers, I would refer to a recent 
study that proves how preferential their tax treatment really is today. 
The nonpartisan Congressional Research Service (CRS) analyzed the tax 
treatment of the pharmaceutical industry and found taxpayer financed 
credits contribute powerfully to lowering the average effective tax 
rate for drug companies--by nearly 40% relative to other major 
industries between 1990 to 1996.
  There should be a responsibility attached to such preferential tax 
treatment and accurate, balanced advertising on matters affecting 
people's lives should be an easy obligation to meet.
  The need for this bill is clear. In an environment where the 
Institute of Medicine (IOM) reported between 48,000 to 98,000 people 
die every year due to medical errors--with medication errors accounting 
for one out of 131 outpatient deaths and one out of 854 inpatient 
deaths--providing medical professionals and consumers balanced 
information about drug risks and side effects is critical.
  By denying tax deductions for unbalanced prescription drug ads, we 
can change pharmaceutical company behavior to ensure that their 
advertising includes clear, life-saving information that will better 
inform the American public, reduce health care expenditures and save 
lives. I look forward to working with my colleagues to make this a 
reality.

                     [From USA Today, May 3, 2000]

                Complex Drug Labels Bury Safety Message

                            (By Rita Rubin)

       If all the information that's supposed to be on 
     prescription labels actually were printed there, pill bottles 
     would have to be 2 feet high. At least.
       Most people don't have medicine cabinets the size of 
     refrigerators. So drug labels have evolved into package 
     inserts, those tightly folded sheets of paper covered with 
     fine print detailing risks and benefits. In many cases, 
     patients never even see the package insert, and when they do, 
     the tiny typeface and medical jargon often leave them more 
     confused than ever.
       Prescribing and taking medicine has never been more 
     complicated, and critics say patients are becoming sick or 
     dying as a result.
       Recent drug withdrawals suggest that doctors, never mind 
     their patients, aren't keeping up. Either they're overlooking 
     warnings scattered throughout inserts or they're not even 
     reading the leaflets.
       ``Less than 1% of physicians have seen a label in the last 
     year,'' cardiologist Robert

[[Page 11148]]

     Califf, director of Duke University's Clinical Research 
     Center, estimated at a recent Food and Drug Administration 
     advisory committee meeting.
       In less than two years, three widely prescribed drugs have 
     been pulled from the market in part, at least, because 
     doctors ignored the package inserts. A fourth will disappear 
     from drugstore shelves this summer for the same reason.
       FDA critics say the agency, which regulates package 
     inserts, expects too much of the leaflets. Instead of 
     withholding approval of potentially dangerous drugs, critics 
     say, the agency sends them to market with inserts jam-packed 
     with warnings.
       ``Should we have relatively dangerous drugs and simply warn 
     people that they might kill or seriously injure them?'' asks 
     Thomas Moore, a health policy fellow at George Washington 
     University in Washington, D.C. ``My perception is that the 
     top management of the FDA seems to have a more permissive 
     view than we have historically had.''
       He and like-minded FDA-watchers are quick to tick off 
     Propulsid, Rezulin, Posicor and Duract, four drugs whose 
     inserts underwent multiple revisions as new safety concerns 
     came to light. In each case, the manufacturer also mailed 
     ``Dear Doctor'' letters to alert physicians of label changes.
       Apparently, though, some doctors never saw the warnings, 
     and patients died. The last three drugs are now off the 
     market, and Propulsid, which is used to treat severe 
     heartburn, will follow them by mid-August.
       ``FDA has an almost ritualistic belief in labeling changes, 
     as if they have some magical property to change behavior,'' 
     says Jerry Avorn, chief of the division that tracks adverse 
     medication events at the Brigham and Women's Hospital in 
     Boston. ``There is very little data to support that belief.''
       The FDA's own research backs Avorn.
       In a ``talk paper'' in January, the FDA noted that 85% of 
     the 270 Propulsid-related adverse side effects reported to 
     the agency--including 70 deaths--occurred in patients with 
     risk factors already listed on the drug's label, such as 
     congestive heart failure or use of antibiotics or 
     antidepressants.
       And after Rezulin's label was changed in late 1997 to 
     recommend monthly liver function tests, the FDA found that 
     far fewer than 10% of patients had the tests.
       Apparently, even the agency's expert advisers don't always 
     follow the package insert instructions.
       At the recent advisory committee meeting, an FDA staff 
     member had to remind urologists on the panel about how to 
     treat patients with Muse, an injectable impotence treatment. 
     Instead of sending men home with a prescription, doctors are 
     supposed to administer the first dose in their office so they 
     can watch for possible side effects.


                             Flawed system

       In many cases, package inserts ``are far from perfect,'' 
     acknowledges Rachel Behrman of the FDA's medical policy 
     office. ``We are working hard to improve that.''
       Recognizing that patients as well as doctors need to read 
     package inserts, the FDA hopes to make them ``more user-
     friendly, more informative, more consistent,'' she says.
       ``If you flip through the PDR, the Physicians Desk 
     Reference, the medication bible that reprints package inserts 
     for nearly all prescription drugs today, some of our labels 
     are very good, and some are not.''
       The older the drug, the more likely its package insert is 
     to fall in the latter category, she says; until recent years, 
     comprehensiveness superceded clarity.
       Still, ``the best available science is often not 
     communicated adequately to practicing doctors to shape their 
     prescribing decisions,'' says Avorn, who lectures Harvard 
     Medical School students on the subject.
       Rezulin, a diabetes drug, looked so dangerous that Avorn 
     and his colleagues advised diabetes doctors at their hospital 
     to stop prescribing it a year before Parke-Davis, at the 
     FDA's urging, pulled it from the market.
       ``I'm astonished that the additional year of product life 
     even existed,'' Avorn says.
       Why does the FDA approve such medications and allow them to 
     stay on the market? ``There are very strong economic and 
     political pressures when a company has spent hundreds of 
     millions of dollars to develop a drug,'' Avorn says.
       Wyeth-Ayerst Laboratories yanked Duract, a painkiller in 
     the same class of drugs as ibuprofen, naproxen and others, 
     from the market in June 1998 after reports of four deaths and 
     eight transplants resulting from severe liver failure. 
     According to the company, all but one of the cases occurred 
     among patients who took the drug for more than 10 days, 
     against the label's advice.
       Just two weeks before Duract came off the market, Roche 
     Laboratories pulled Posicor, which is used to treat high 
     blood pressure and chest pain.
       Taking Posicor with any of a number of commonly used drugs, 
     including some heart disease treatments, could lead to 
     potentially fatal heartbeat irregularities, the same problem 
     that led to Propulsid's impending withdrawal.
       As with Propulsid, changes to Posicor's label were designed 
     to minimize the drug interaction risk.
       ``In principle, drug interactions can be addressed by 
     appropriate labeling; however, with respect to Posicor, Roche 
     Laboratories believes that the complexity of such prescribing 
     information would make it too difficult to implement,'' the 
     company wrote in a ``Dear Doctor'' letter announcing 
     Posicor's withdrawal.
       At least one drug, sorivudine for shingles, never made it 
     to the U.S. market because of concerns about the 
     effectiveness of label warnings. The pill was withdrawn in 
     Japan after 15 users died in just its first month on the 
     market. They had developed aplastic anemia, a blood disorder, 
     after taking sorivudine with a common anti-cancer drug.
       Three years later, Bristol Myers Squibb representatives 
     argued before an FDA advisory committee that a ``black box 
     warning''--like the ones on cigarette packages--would 
     adequately minimize sorivudine's risks.
       ``No one was convinced that it would work,'' says Raymond 
     Woosley, chairman of pharmacology at Georgetown University in 
     Washington, D.C., and a member of that committee, which 
     recommended not approving sorivudine.
       Because a drug already on the market, acyclovir, provided a 
     similar benefit with far less risk, the agency followed the 
     advisory committee's recommendation, the FDA's Behrman says. 
     ``We believed zero deaths was the only acceptable number.''


                           Risk vs. benefits

       Rezulin, on the other hand, was the first drug of its 
     class. FDA officials have said the agency sought to remove 
     that drug from the market only after similar, safer 
     medications became available.
       ``I've heard that line, but I don't buy it,'' Avorn says. 
     ``It's as if we don't have other medications to treat 
     diabetes.''
       The risk/benefit issue arose at the FDA advisory committee 
     meeting, where panelists recommended approval of Uprima, 
     which would be the second impotence pill on the market.
       Pre-market studies showed that the drug can trigger 
     fainting, especially when taken with alcohol, so committee 
     members suggested a black box warning against drinking on 
     Uprima's label.
       But panel member Thomas Graboys, who had to leave the 
     meeting early, says he would have voted against Uprima, 
     partly because of concerns about the label's ability to 
     protect patients.
       When the condition a drug treats isn't life-threatening, 
     only the lowest level of risk is acceptable says Graboys, 
     director of the Lown Cardiovascular Center at Brigham and 
     Women's Hospital.
       Much inappropriate prescribing could be eliminated if 
     doctors actually read package inserts or looked up the drugs 
     in their PDRs before prescribing them, Woosley says.
       Instead, they rely on memory, a Herculean task when one 
     considers that one doctor might prescribe scores of drugs. 
     But that's what they're taught to do in medical school, 
     Woosley says. Doctors wrote nearly 3 billion prescriptions 
     last year; the number is expected to reach 4 billion annually 
     by 2004.
       ``We've got to start by changing the way we teach people,'' 
     he says. Among his students, ``the kid who gets the `A' is 
     the one who says `I don't know, but I'll look that up and get 
     back to you.' ''

     

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