[Senate Hearing 110-624]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 110-624
 
                  UNDER THE INFLUENCE: CAN WE PROVIDE
             DOCTORS AN ALTERNATIVE TO BIASED DRUG REVIEWS?

=======================================================================

                                HEARING

                               before the

                       SPECIAL COMMITTEE ON AGING
                          UNITED STATES SENATE

                       ONE HUNDRED TENTH CONGRESS

                             SECOND SESSION

                               __________

                             WASHINGTON, DC

                               __________

                             MARCH 12, 2008

                               __________

                           Serial No. 110-24

         Printed for the use of the Special Committee on Aging



  Available via the World Wide Web: http://www.gpoaccess.gov/congress/
                               index.html


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                       SPECIAL COMMITTEE ON AGING

                     HERB KOHL, Wisconsin, Chairman
RON WYDEN, Oregon                    GORDON H. SMITH, Oregon
BLANCHE L. LINCOLN, Arkansas         RICHARD SHELBY, Alabama
EVAN BAYH, Indiana                   SUSAN COLLINS, Maine
THOMAS R. CARPER, Delaware           MEL MARTINEZ, Florida
BILL NELSON, Florida                 LARRY E. CRAIG, Idaho
HILLARY RODHAM CLINTON, New York     ELIZABETH DOLE, North Carolina
KEN SALAZAR, Colorado                NORM COLEMAN, Minnesota
ROBERT P. CASEY, Jr., Pennsylvania   DAVID VITTER, Louisiana
CLAIRE McCASKILL, Missouri           BOB CORKER, Tennessee
SHELDON WHITEHOUSE, Rhode Island     ARLEN SPECTER, Pennsylvania
                 Debra Whitman, Majority Staff Director
            Catherine Finley, Ranking Member Staff Director

                                  (ii)

  
?

                            C O N T E N T S

                              ----------                              
                                                                   Page
Opening Statement of Senator Herb Kohl...........................     1
Opening Statement of Senator Gordon Smith........................     2
Opening Statement of Senator Claire McCaskill....................    48

                           Panel of Witnesses

Shahram Ahari, former Eli Lilly pharmaceutical sales 
  representative, El Cerrito, CA.................................     4
Jerry Avorn, professor of Medicine, Harvard Medical School, 
  Brigham and Women's Hospital, Boston, MA.......................    16
Allan Coukell, director of Policy and Strategic Communications, 
  The Prescription Project Group, Boston, MA.....................    22
Nora Dowd Eisenhower, secretary, Pennsylvania Department of 
  Aging, Harrisburg, PA..........................................    33
Ambrose Carrejo, assistant director, Pharmaceutical Contracting 
  and Strategic Planning, Kaiser Permanente, Livermore, CA.......    38

                                APPENDIX

Fact Sheet, Academic Detailing: Evidence-Based Presribing 
  Information from the PRESCRIPTIONPROJECT.ORG...................    57

                                 (iii)

  


 UNDER THE INFLUENCE: CAN WE PROVIDE DOCTORS AN ALTERNATIVE TO BIASED 
                             DRUG REVIEWS?

                              ------------


                       WEDNESDAY, MARCH 12, 2008

                                       U.S. Senate,
                                Special Committee on Aging,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 10:32 a.m., in 
room SD-562, Dirksen Senate Office Building, Hon. Herb Kohl 
(chairman of the committee) presiding.
    Present: Senators Kohl, McCaskill, and Smith.

        OPENING STATEMENT OF SENATOR HERB KOHL, CHAIRMAN

    The Chairman. Good morning to one and all. We welcome and 
thank you for being at this hearing.
    We would particularly like to thank and welcome all of our 
distinguished witnesses here this morning.
    Over the past year, the Committee on Aging has been taking 
a close look at the relationship between the pharmaceutical 
industry and our nation's physicians. Not only does the 
interaction between these two parties seem to be fraught with 
conflicts of interest, but it is likely that the marketing 
methods employed by drug companies and the manner in which they 
educate doctors about their products do have an impact on the 
rising costs of prescription drugs in America.
    To address these concerns, Senator Grassley and I 
introduced the Physician Payment Sunshine Act, to require that 
all gifts, fees and other freebies given to doctors by the drug 
industry, medical device manufacturers and biologic companies, 
be reported in a National registry. The drug industry argues 
that such disclosure would deter physicians from engaging in 
the most important aspect of their relationship, which they 
consider to be educating doctors about their new drugs.
    The drug industry does have a point. Pharmaceutical sales 
reps are currently one of the only ways doctors can learn about 
the latest drugs on the market. However, these sales 
representatives often confuse educating with selling, and the 
evidence shows that doctors' prescribing patterns can be 
heavily influenced by the biased information often put forward 
by these sales reps.
    So today, we will address the industry's concerns by 
presenting an alternative known as ``academic detailing,'' that 
we believe would have a positive impact on both quality and 
cost of health care Nationwide. Academic detailing provides 
physicians and other prescribers with an objective source of 
unbiased information on all prescription drugs, based on 
scientific research performed at medical and pharmacy schools.
    The information is presented to doctors in their own 
offices by trained clinicians and pharmacists. Without academic 
detailing, physicians are often left largely uninformed about 
drug safety or the full array of pharmaceutical options, 
including low-cost generic alternatives.
    For example, the National consumer group, Public Citizen, 
did a study on the blood pressure drug Norvasc. While most 
academic guidelines recommend the use of an older generic drug 
over the use of Norvasc, Norvasc was the drug most often 
distributed by doctors and, in fact, was the fourth most 
prescribed drug in the United States in 2004.
    The study found that this was in part due to the fact that 
a fleet of pharmaceutical company salespeople were dispersed to 
physicians' offices, pitching the drug as a new and effective 
alternative, and offering free samples of the drug to doctors 
to give to their patients.
    Certainly, we can agree that in some of these instances, 
patients were not receiving the best drug, merely the most 
convenient--and they were paying more for it. The monthly cost 
of Norvasc is between $60 and $70. The generic cost is about 
$12.
    Since the Federal Government is the nation's largest 
purchaser of prescription drugs, these inflated costs should be 
of great concern both to Congress and, most importantly, to 
taxpayers.
    In this way, a Federal academic detailing program, like the 
one Senator Dick Durbin and I will propose in upcoming 
legislation, would save the government a considerable amount of 
money. We are not proposing that expense be the main factor in 
deciding a course of treatment for a patient. But research has 
shown that when doctors have full access to comprehensive and 
unbiased data on all the drugs available, they prescribe the 
best drug, and not just the newest one, and health care 
spending is lower.
    We are pleased to have a comprehensive panel of witnesses 
here today to outline the practice of academic detailing, speak 
about State and private programs already in place, and explore 
how these counter-detailing initiatives can reduce costs and 
improve health care in our country.
    So again, we would like to thank everyone for their 
participation today, and we turn now to the Ranking Member, 
Senator Gordon Smith, for whatever comments he would like to 
make.

  OPENING STATEMENT OF SENATOR GORDON H. SMITH, RANKING MEMBER

    Senator Smith. Thank you, Senator Kohl, for bringing this 
interesting and important topic to the attention of this 
Committee. I truly thank the witnesses for being here. I look 
forward to learning from you and from the testimony that you 
will give to us today.
    Obviously, the doctor-patient relationship is the 
cornerstone of the American health care system. That is why I 
am here, and that is why I am concerned about any practice that 
attempts to influence this relationship in a way that may or 
may not be in the best interests of the patient.
    An important component of any successful health care 
approach is the dissemination of evidence-based and well 
researched information to physicians. Accurate, up-to-date 
information is crucial in order for physicians to make informed 
decisions when prescribing often lifesaving medication.
    I am committed to looking at all the alternatives that will 
help our dedicated health professionals in providing the 
highest quality of care to their patients.
    So, to that extent, I welcome this opportunity to learn 
more about academic detailing and the potential it holds to 
serve as another resource for doctors in obtaining information 
on comparative efficacy, safety and cost-effectiveness of 
pharmaceuticals.
    Again, thank you, Mr. Chairman.
    The Chairman. Thank you very much, Senator Smith.
    We are now pleased to welcome our witnesses to testify 
today. Our first witness will be Shahram Ahari.
    A former pharmaceutical sales rep from Eli Lilly's 
neuroscience division, Mr. Ahari left the industry to pursue 
public health and social justice issues. He has been a 
consultant to State and Federal policymakers on the issue of 
drug marketing's impact on public health, and the relationships 
between drug detailers and physicians. Mr. Ahari has a master's 
in public health from UC-Berkeley.
    Our next witness will be Dr. Jerry Avorn. Dr. Avorn is 
professor of medicine at Harvard Medical School and a division 
chief at Brigham and Women's Hospitals. A pioneer of academic 
detailing approach, he studies physician prescribing practices 
and programs to improve the appropriateness of prescribing. Dr. 
Avorn received his M.D. from the Harvard Medical School.
    We will then hear from Allan Coukell, the director of 
Policy and Strategic Communications at The Prescription 
Project. As a clinical pharmacist at the Victoria Hospital in 
London, Ontario, he specialized in advising physicians on 
choice of medications and cost-effective prescribing. Mr. 
Coukell studied pharmacy at the University of Manitoba.
    Next we have Nora Dowd Eisenhower, secretary of the 
Pennsylvania Department of Aging. The secretary manages a 
network of services provided in part through a statewide system 
of 52 Area Agencies on Aging. Prior, she served as the state's 
deputy attorney general in the Bureau of Consumer Protection, 
as well as the executive director of AARP of Pennsylvania. She 
received her law degree from Antioch University.
    Finally, we will have Ambrose Carrejo. Mr. Carrejo is the 
assistant director of Pharmaceutical Contracting and Strategic 
Purchase for Kaiser Permanente, where he has responsibility for 
contracting the program's pharmaceutical purchases. Prior to 
that he was the drug use manager for Northern California Kaiser 
Hospitals. He received his doctor of pharmacy degree from the 
University of California at San Francisco's School of Pharmacy.
    We welcome you all here today. We look forward to your 
testimony.
    Mr. Ahari, we will start from you.

  STATEMENT OF SHAHRAM AHARI, FORMER ELI LILLY PHARMACEUTICAL 
              SALES REPRESENTATIVE, EL CERRITO, CA

    Mr. Ahari. Thank you.
    Among the myriad of myths that the industry uses to justify 
the pharma-physician relationship, none is more dangerous than 
the notion that the drug rep provides valuable education to the 
doctor. As their formal title implies, pharmaceutical sales 
representatives are hired to sell. Period.
    The idea that the drug rep is an effective vehicle for 
disseminating objective science is pure fiction. Drug reps are 
not scientifically trained, they are not provided with 
objective scientific information, and it is not in their 
economic self-interest to distribute evenhanded information 
about therapeutic choices.
    While there is nothing intrinsically wrong with sales, the 
great extent to which physicians believe that they are 
recipients of a wholesome, evenhanded view of the science 
endangers not only the doctor's judgment, but the public's 
health and the very foundations of the patient-physician 
relationship.
    To begin with, it is no coincidence that we reps are often 
recruited from the ranks of former cheerleaders, ex-military 
men or athletes, rather than those trained in the sciences. It 
is also no mistake that our sales training focuses on 
persuasion skills.
    We are taught to present our products in the best possible 
light, to trivialize problems associated with them and to 
emphasize the shortcomings of our competitors' products. Our 
instructors walk us through the academic articles that our 
marketing department has deemed most relevant to our current 
sales strategy, cherry-picking the data along the way.
    From these selected articles, we receive neither a balanced 
nor a comprehensive sense of the literature. We learn only how 
to limit the scope of our discussions to most effectively sell 
our products.
    This training, combined with our persuasiveness and 
controversial physician prescriber data, allows us to make our 
targeted discussions seem unrehearsed and coincidental.
    To reinforce our sales efforts, we look for credible, loyal 
physicians to speak on our product's behalf. We count these 
doctors as objective thought leaders, but we have no 
reservations in dismissing them when their product loyalty 
falls into question.
    Furthermore, we supply these doctors with presentations 
crafted by our marketing department, that expound on the points 
that we reps make. This provides marketing synergy. It is like 
the physician's repeated sales pitch masked in scientific 
credibility.
    Although drug reps learn a modicum of science, the fact is 
our science training is secondary to our ability to establish a 
friendship with our clients, and we maximize every opportunity 
to befriend them.
    For example, when I was recruited for Eli Lilly's elite 
neuroscience and sales division, selling two products--an 
antidepressant and an antipsychotic--that constituted over half 
of the company's profits, I was in a room with 21 classmates 
and two trainers, and I was the only one with a science 
background.
    In fact, on the first day of training, I taught my class--
and my instructors--the very basic process by which two brain 
cells communicate.
    It is very likely that the majority of my class couldn't 
explain the difference between a neuron and a neutron prior to 
sales school, which is not to say that my classmates weren't 
intelligent. On the contrary, we were all charming, bright 
and--myself the obvious exception--physically attractive. 
[Laughter.]
    Yet, for all my abilities to discuss the pharmacological 
benefits of my products, I can attest to the many times when my 
clients would begin prescribing more of my drugs, not based on 
the merits of my arguments, but on the fact that we shared 
dinner at a fancy Manhattan restaurant.
    How did I know this? The physician prescriber data showed a 
distinct rise in my market share after these meals.
    But a fancy dinner doesn't influence all physicians. So to 
better understand our clients' motivations, we were given 
psychological profile training, beginning with our own 
psychological profile. By evaluating ourselves, we learned to 
assess our doctors. We learn how our personality traits overlap 
with our physicians' traits, and how best to ingratiate 
ourselves toward our clients.
    We seek out personal details from our encounters with the 
doctors and analyze them to determine what sales methods will 
be the most effective. This information gets recorded, compiled 
and shared company wide throughout the years, without doctors' 
consent, or often, even their awareness. We download these 
details onto our laptops daily, so we can diligently pore over 
them before every visit to the doctor's office to best tailor 
our strategy to maximize sales.
    We not only enter a physician's office armed with 
information, but also with a vast arsenal of gifts, including 
pens, pads, clipboards, food and samples. We have many subtle 
ways to remind doctors of our generosity.
    In doing so, we cultivate in them a sense of obligation, 
whether the physician realizes it or not. I can assure you, 
most often they don't.
    We befriend nurses and pharmacists to act as our agents in 
our efforts to affect physician prescribing. For me, nothing 
was more satisfying than to hear a nurse deliver my exact sales 
message to an unsuspecting physician. In essence, it was 
selling by proxy.
    We tracked down formulary Committee members and lavished 
them with attention in effort to promote our products on a 
larger scale.
    In short, we are salespeople, and we market our products as 
one would any other product. But for obvious reasons, 
pharmaceuticals are unlike other products, because they can 
affect health.
    When my personal physician wrote me a prescription, I 
couldn't help but wonder, ``Did he select this drug for me 
because of the evidence, or because he had a fancy rep dinner 
the night before?'' Thank you.
    [The prepared statement of Mr. Ahari follows:]

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    The Chairman. Thank you, Mr. Ahari.
    Dr. Avorn.

   STATEMENT OF JERRY AVORN, PROFESSOR OF MEDICINE, HARVARD 
    MEDICAL SCHOOL, BRIGHAM AND WOMEN'S HOSPITAL, BOSTON, MA

    Dr. Avorn. Thank you, Senator Kohl, Senator Smith.
    If they are used well, especially in older patients, 
prescription drugs can reduce disability late in life and be 
very cost effective. But they can also cause needless drug-
induced illness, especially in older patients, and it can 
impose a heavy burden on patients and on public budgets. Some 
preventive drugs are actually under-used in the elderly.
    I am here today to discuss with you an approach that can 
improve the quality and accuracy of medication use, as well as 
contain its spiraling costs.
    There is a huge gap between the best available drug 
knowledge out there and the prescriptions that many patients 
actually receive from their doctors. Each week, medical 
journals publish so much new information that it is nearly 
impossible for doctors to keep up with it. Important findings 
might be reported in any of 100 journals, and it is no one's 
job to make sure that we see them or monitor how well our 
prescribing is being done.
    But into that void rushed tens of thousands of attractive, 
articulate people like Mr. Ahari, who come and visit us in our 
offices each week, nicely dressed and often bearing gifts, to 
teach us how to prescribe for our patients, even though, as was 
noted, most of them don't have any formal scientific training.
    They are drug company salespeople, or detailers, who are 
paid based on how much they can increase sales of their 
company's products. Unfortunately, for many primary care 
doctors, this information about drugs--especially new ones--is 
the most important source of information about prescribing.
    The sales reps are smooth, cordial and concise. The 
material they give us is slick, engaging and easy to 
understand. There is always a clear, final, take-home point at 
the end of their presentation, pushing use of their company's 
usually costly product, even if it has less of a safety track 
record and is no better than what we have been prescribing for 
years, or perhaps even less effective.
    This informational playing field is not level. 
Manufacturers of generic drugs don't have the funds or the 
incentive to come to our offices and present their side of the 
story, even when the evidence is on their side. Those of us who 
are on medical school faculties, I must admit, are often not 
very good communicators, although we do tend to have a more 
balanced viewpoint.
    We give our continuing education courses in big lecture 
halls. We drone on for hours in darkened rooms, showing slides 
that are as visually interesting as the Congressional Record.
    The articles that we write in medical journals may contain 
vital data, but they are often boring to read and cover only a 
sliver of the clinical topic. As a result, doctors prescribe 
the drugs that are the most heavily promoted, not necessarily 
the ones that would be the safest, the most effective or the 
most economical for our patients.
    We have seen that happen recently with Avandia, Vytorin, 
Vioxx several years ago, and other widely used drugs, with bad, 
negative consequences, both clinically and economically.
    Ironically, much of this misuse is paid for with taxpayer 
money--enough to fund more balanced drug education programs 
dozens of times over.
    For nearly 30 years, my colleagues and I at Harvard have 
been working on this idea. What if we could take the very 
effective communications and behavior change tools that the 
drug companies use so well, but instead deploy them simply to 
give doctors the latest and best balanced facts about the drugs 
that we prescribe?
    To do this, we trained pharmacists and nurses to go visit 
physicians as un-sales reps, to provide educational outreach 
about common prescribing topics. I named the approach 
``academic detailing,'' because it used the detailer approach 
of sending someone to meet with a doctor in his own office, but 
we did it from a non-commercial and academic perspective.
    We have shown that the concept works in several large, 
randomized trials published in the ``New England Journal of 
Medicine'' and other journals.
    The vast majority of physicians who are offered this 
service accept it, and we have shown that it significantly 
improves their prescribing. In a formal benefit-cost analysis, 
we found that such a program could save $2 for every $1 that it 
costs to run. This was not a surprise. It is how the drug 
companies move prescribing in the directions that they want. 
They know exactly what they are doing.
    Many additional studies have shown that academic detailing 
programs can improve the use of a wide variety of drugs, from 
antibiotics to sedatives, in settings from primary care offices 
to teaching hospitals to nursing homes.
    Some of these programs have also tracked clinical data, and 
have shown that patients' outcomes also improve, as expected, 
with more evidence-based prescribing. Today, academic detailing 
services have been set up in England, the Netherlands, Canada, 
Australia and several U.S. states.
    The Pennsylvania program, which we will hear about from 
Nora Dowd Eisenhower, is the largest publicly funded service at 
present in the country. You will hear about that shortly.
    It is conducted on a completely nonprofit basis in 
collaboration with my colleagues and me at Harvard Medical 
School. We develop the materials based solely on the best 
evidence in the medical literature, with no interference from 
the State. Sometimes we encourage greater use of expensive 
drugs, if that is the best thing to do for the patient.
    Doctors can get continuing medical education credit from 
Harvard through participating, and they find this to be a user-
friendly and efficient way to keep up with the medical 
literature. We put everything we produce on the Internet for 
free, non-commercial use by anyone at our rxfacts.org. I have a 
packet of our materials to share with the Committee.
    Economically, we have found that just one of our modules 
has saved over half a million dollars a year through the PACE 
program alone--not counting the savings to Medicaid, Medicare 
and private insurers. Other programs around the world have also 
shown that their costs are largely offset by savings from 
reducing excessively costly prescribing, not even counting the 
benefits that result from improved clinical care.
    In sum, academic detailing is not a ``just say no to 
drugs'' program. Prescribing is one of the most useful and 
challenging things that we doctors do. We crave accessible, 
unbiased data about the medicines that we use every day. 
Getting current, noncommercial, balanced drug information out 
to doctors is an important public good.
    I commend the Committee for proposing such programs on a 
larger scale. Now that Medicare has become the nation's single 
biggest payer of drug bills, it would be fiscally irresponsible 
not to equip doctors with the balanced information we need to 
make the best choices for our patients.
    Well-run academic detailing services would enhance both the 
medical effectiveness and the affordability of the drugs we 
prescribe, especially for our older patients.
    Thank you.
    [The prepared statement of Dr. Avorn follows:]

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    The Chairman. Thank you very much, Dr. Avorn.
    Mr. Coukell.

 STATEMENT  OF ALLAN COUKELL, DIRECTOR OF POLICY AND STRATEGIC 
   COMMUNICATIONS, THE PRESCRIPTION PROJECT GROUP, BOSTON, MA

    Mr. Coukell. Good morning, Mr. Chairman, Senator Smith.
    I am the director of policy for The Prescription Project, 
which is funded by the Pew Trusts to promote appropriate 
prescribing and to encourage a stronger ethical framework 
between medicine and industry.
    I appreciate the opportunity to appear today, and to focus 
on the savings from the prescriber education programs known as 
academic detailing. These are programs that provide doctors 
with unbiased information on the safest, most effective and, 
other things being equal, the least costly drugs. Choosing the 
best drug means cost savings for patients, for public and 
private programs and for taxpayers, whether or not they take 
medication.
    I would like to begin with a number that Dr. Avorn 
mentioned, that for every dollar spent on an academic detailing 
program, two dollars can be saved in drug costs. The number 
comes from his economic model, and it is based on real world 
effectiveness data.
    The original study in the ``New England Journal of 
Medicine,'' involved 141 doctors in the Medicaid programs of 
Arkansas, New Hampshire, Vermont and the District of Columbia. 
It focused on three particular drugs that tended to be 
overprescribed, and found that educational visits substantially 
reduced use, at cost savings of about $20,000 a year.
    That is more than enough to offset the cost of running the 
program. Those savings were only to Medicaid, even though these 
doctors also saw patients with other types of coverage. The 
total net real savings were almost certainly higher.
    The model then looked at expanding this pilot program to a 
full-scale program that would visit 10,000 doctors a year, and 
concluded, as I have said, a most likely benefit-to-cost ratio 
of almost two to one.
    I should say, this study was in the early 1980's, when the 
cost of prescription drugs was much, much lower. Labor has 
increased since then, but not as much as drugs. Drugs that 
seemed expensive then would be a bargain today. That suggests 
even greater potential for savings.
    Next, let me turn to the PACE program in Pennsylvania, 
about which you will hear more shortly, and an analysis that 
focused on just one group of drugs, the so-called ``little 
purple pill'' for acid reflux, and its cheaper, equally 
effective cousins.
    This program demonstrated reduced drug costs of about $120 
per doctor per month. For the heaviest prescribers, the 
reduction was $378 per doctor per month. If the pattern 
persists for a year, it would reduce spending by half a million 
dollars against total costs for running the program of about $1 
million.
    It is important to point out again, these are savings only 
for one class of drugs, and the program focuses on multiple 
classes, and only for patients in the PACE program, who are 
just a fraction of the total caseload for any physician. 
Savings in other drug classes and to other programs, including 
Medicaid, Medicare Part D, State employees and private plans, 
are likely to more than offset the cost of running the program.
    Other countries, notably Canada and Australia, make 
extensive use of academic detailing. With nearly 12,000 
doctors, the Australian program is the largest and most 
established in the world, and over the past decade has produced 
savings--net savings--of a $300 million.
    While there are differences between health systems, again, 
in general, prescription drugs are much more expensive in the 
United States than in these other countries. That suggests even 
greater potential savings.
    I can't review every available economic analysis today, but 
a table in my written testimony summarizes them. Let me 
emphasize that these programs consistently improve prescribing 
and do it better than other approaches.
    Senator Smith. Could I ask you a question?
    Mr. Coukell. Yes, sir.
    Senator Smith. I do this with the chairman's permission. In 
Australia, I believe they have some limitation on how drugs are 
marketed. Do they prohibit the kind of slicked up approach that 
Mr. Ahari spoke of?
    Mr. Coukell. That also exists in Australia.
    Senator Smith. They allow it there as well?
    Mr. Coukell. They do.
    Senator Smith. Is there any requirement that the doctors 
also get academic detailing.
    Mr. Coukell. Academic detailing. It is a voluntary program, 
although, on the order of 80 to 90 percent of doctors offered 
this service participate.
    Senator Smith. Do they use it?
    Mr. Coukell. They do, clearly.
    Senator Smith. I am not sure if physicians in Australia 
have the same liability concerns that physicians in America 
have. But I would assume in America physicians have every 
incentive to provide the best choice in care, in part due to 
liability concerns.
    Mr. Coukell. Absolutely.
    Senator Smith. Thank you.
    Mr. Coukell. In terms of the broader potential for savings, 
let me say that it is estimated that we as a nation could save 
$8.8 billion each year from the optimal use of generic drugs. 
Even if we look at just one condition, the treatment of 
hypertension (or high blood pressure) estimates say that we 
could save $433 million a year, just by prescribing the drug 
that experts agree should be the first choice for most 
patients.
    Instead, we see the extensive use of heavily marketed and 
expensive newer drugs that don't have clear advantages. There 
are studies to demonstrate that academic detailing can improve 
matters in a cost-effective way.
    Finally, so far I have been talking only about drug 
savings, only about the drug budget. But even more important 
may be the potential to change prescribing in a way that 
improves health and prevents disease. Imagine the health care 
savings when a change in prescribing avoids just one heart 
attack, or gets an elderly person off an inappropriate 
sedative, and thereby prevents a broken hip.
    Such studies exist. One showed enormous savings from an 
academic detailing program that changed prescribing, and 
thereby prevented gastrointestinal bleeds. Another looked at 
changing prescribing for people with heart failure. In that 
case, the program was estimated to cost about $2,500 per year 
of life gained. That is a low price to pay to give someone an 
extra year of life.
    I would like to thank you for examining this important 
issue. The Federal Government has long been the major funder of 
graduate medical education for doctors. Medicare Part D, means 
the government now also pays a very large share of drug costs. 
We are pleased that you see the potential to extend the Federal 
role in physician education to save lives and save taxpayer 
dollars.
    [The prepared statement of Mr. Coukell follows:]

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    The Chairman. Thank you, Mr. Coukell.
    Ms. Eisenhower.

  STATEMENT OF NORA DOWD EISENHOWER, SECRETARY, PENNSYLVANIA 
              DEPARTMENT OF AGING, HARRISBURG, PA

    Ms. Eisenhower. Good morning, senators. I am really pleased 
to be here today to talk to you about a program that we have 
been working on in Pennsylvania for several years.
    But before I do that, I would like to talk to you a little 
bit about the history of our program.
    PACE is the senior pharmacy program in Pennsylvania. It has 
been around since 1984. During this past fiscal year that ended 
on June 30, 2007, Pennsylvania spent 10 percent of its annual 
budget--that is $2.5 billion--reimbursing for prescription 
medications for over two million of its residents. That is 
older Pennsylvanians who qualify for the PACE and PACENET 
program Medicaid recipients, State employees and retirees.
    Many of the individuals who are covered under these 
programs are in frail health with multiple chronic conditions 
requiring daily maintenance medication. They are enrolled in a 
dozen different and disparate programs, most of which provide 
comprehensive prescription drug coverage with nominal cost 
sharing to the beneficiary.
    Over 80 percent of our annual prescription drug spending is 
for three programs, Medicaid, our State employees and retiree 
program, and PACE our senior pharmacy assistance program--one 
of the best in the country. It has led the way in many areas, 
because doctors like Jerry Avorn and Tom Snedden, the director 
of the program, have been managing the program.
    Tom has been director of the program for over two decades. 
PACE has led the way in many areas, and academic detailing is 
an area we think should be adopted more broadly, because of the 
effectiveness we see in PACE.
    When Governor Rendell took office in 2003, enrollment in 
our program was low, and the effects of direct-to-consumer 
advertising was driving utilization of many medicines. Most 
importantly, we saw explosive growth over several years 
preceding in the direct-to-physician promotion--very effective 
promotion that you have heard described here. We really noticed 
that the physicians we spoke to, and the consumers in our 
program were very frustrated by this and looking for 
independent information, and it was very, very hard to obtain.
    So, we saw that utilization review--or edits at the point 
of sale at the pharmacy--were effective, but rather heavy-
handed. What we wanted to do in using academic detailing is to 
go directly to the physicians and return them to their place of 
prominence in the prescribing decision. That is exactly what I 
think this program does.
    You have heard statistics. You have heard about sales 
pitches, very smooth sales pitches--that are very effective. We 
have tried to take the best in that and use the social 
marketing approach that Dr. Avorn has developed. You will see 
that demonstrated in the materials available here.
    They are very--they are not slick, but they are very 
professional. They inspire the doctors to have confidence that 
what they are prescribing is really the most effective, and not 
just the most cost-effective. Although I can tell you that 
identifying the most cost-effective is a big part of our goal 
in making this information available and working with doctors 
the way we have.
    In addition to that, there are materials that the doctors 
can give to their patients. I think every one of us has 
experienced watching an ad on television. We are not quite 
certain what the advertisement is for. We figure it out. We go 
into the doctor and we want that. We want the little purple 
pill. You have heard about the effectiveness of this program in 
helping people understand that the little purple pill may not 
be the best thing for them.
    That is really where this program is different from other 
programs that I have seen in government, some occur at the 
point of sale to cut off a prescription without an explanation. 
Academic detailing steps back and gives the doctor the 
information they need at the point in time when she or he is 
discussing medication with a patient and this make this 
prescribing much more effective.
    We know doctors want this evidence. They have told us so. 
They want the data, which helps them make their decisions 
better decisions. We know that the expert in prescribing 
decisions need to be the doctor. The information that we are 
providing makes sure that happens.
    That is the end of my presentation. I would be happy to 
answer any questions for you today.
    [The prepared statement of Ms. Eisenhower follows:]

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    The Chairman. Thank you.
    In your presentation, did I miss it, or did you describe 
how extensive this program is in Pennsylvania right now?
    Ms. Eisenhower. Well, we are beginning it in Pennsylvania. 
We have it in several counties now and are targeted doctors who 
we know are prescribing higher levels than we think they should 
in particular medications. One example is the proton pump 
inhibitors. But there are several other areas that we cover. We 
are expanding it to other medications. We started the academic 
detailing in 2005, and we are growing it.
    There are 12 detailers in the field--nothing compared to 
the detailers that are in the field for the pharmacy 
industries, but it is a strong start.
    The Chairman. OK.
    Ms. Eisenhower. We think that that is a good start and plan 
to expand it.
    The Chairman. OK. It is a pilot program?
    Ms. Eisenhower. Yes.
    The Chairman. Thank you.
    Mr. Carrejo.

       STATEMENT OF AMBROSE CARREJO, ASSISTANT DIRECTOR, 
   PHARMACEUTICAL CONTACTING AND STRATEGIC PLANNING, KAISER 
                   PERMANENTE, LIVERMORE, CA

    Mr. Carrejo. Good morning, Chairman Kohl, distinguished 
Committee members.
    I am Ambrose Carrejo, a pharmacist leader for Kaiser 
Permanente. We are the nation's largest integrated health care 
delivery system, providing services to more than 8.7 million 
members in nine states and the District of Columbia.
    Permanente physicians prescribed, and Kaiser pharmacists 
dispensed, more than 60 million prescriptions last year at a 
cost of over $3 billion.
    For most of my 18-year career with Kaiser Permanente, my 
work was focused on organizing and conducting academic 
detailing, programs to ensure that our physicians have the 
information they need to make the best possible prescribing 
decisions.
    At Kaiser Permanente, we call academic or counter detailers 
``drug education coordinators,'' or simply DECs.
    Our DECs are all doctors of pharmacy. They begin by 
evaluating clinical evidence and reviewing prescription drug 
utilization data, and then work with physician leaders to 
communicate one-on-one and in groups with all Permanente 
physicians.
    Today, I would like to discuss one example of how our 
program provided both great economic value and great quality 
and safety improvement in drug use. It is the COX-2 inhibitors, 
such as Celebrex, Vioxx and Bextra.
    They represent a type of non-steroidal anti-inflammatory 
drug--or NSAID, if you will--that has been used to treat pain 
and inflammation due to arthritis. It was believed that COX-2 
inhibitors would provide an advantage over the older NSAIDs, 
like ibuprofen, or Motrin, and naproxen, or Naprosyn.
    These are presumed to cause significant gastrointestinal 
side effects, including bleeding from gastrointestinal ulcers.
    We now know that high doses of these drugs represent a 
significant cardiovascular risk for patients. As of today, two 
of the three COX-2 inhibitors--Vioxx and Bextra--have been 
removed from the market.
    Even before the early hints of the serious cardiovascular 
risk were confirmed and widely accepted by the medical 
community, work done by scientists at Stanford University 
showed that the potential gastrointestinal safety benefit of 
COX-2 inhibitors was largely limited to patients who were at 
high risk of serious gastrointestinal bleeding from the 
traditional NSAIDs. This was important, because they found that 
fewer than 5 percent of patients are actually at high risk for 
those side effects.
    In the very practical response to these data, the same 
scientists developed a scoring tool to apply to patients who 
were candidates for NSAIDs, to determine their risk limits. 
Kaiser Permanente adopted this scoring tool to provide 
physicians with simple, automated methods to know the risk 
levels of the patients they were seeing.
    We used academic detailing to educate physicians about the 
tools and the science behind it, and to help them decide which 
patients stood best to benefit from what drugs.
    The concerted work of physicians and pharmacists resulted 
in limiting Kaiser Permanente's use of COX-2s to below 5 
percent of all NSAIDs. During the same period of time, COX-2s 
represented close to 50 percent of the National NSAID market. 
Our work targeted these agents to appropriate patients, and 
ultimately decreased the number of individuals exposed to the 
increased risk of cardiovascular events.
    Without the experience we gained over the years from 
academic detailing techniques, we would have had a far more 
difficult time implementing this program, and physicians would 
not have been as well prepared to respond to patient requests 
for the drugs generated by the breathtaking levels of consumer 
advertising of COX-2s.
    In 2004 alone, if community use of the COX-2s compared to 
traditional NSAIDs had matched that of Permanente physicians, 
U.S. consumers and businesses would have saved over $4 billion, 
or almost 2 percent of all drug spending.
    Expanded use of academic detailing has a potential to 
provide the same great value to all Americans that it does for 
Kaiser Permanente members. I applaud the Committee for its 
leadership in highlighting and encouraging this important work.
    Mr. Chairman, thank you for the invitation to testify here 
today, and I would be happy to answer any questions you may 
have.
    [The prepared statement of Mr. Carrejo follows:]

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    The Chairman. Thank you, Mr. Carrejo.
    Mr. Ahari, in your experience, did the doctors that you 
talked to question your facts as you presented them in 
comparison with pharmaceutical company-produced information 
about the drugs that you were trying to sell?
    Mr. Ahari. Rarely, Senator. Doctors were more, I guess, 
welcome to see me as a reprieve to their day than they were to 
question the actual merit of my academic arguments.
    We were possibly the only person to step into their office 
not complaining of any illness, not having a handful of 
paperwork for them to fill out. We had an armload of gifts, 
generally speaking, made us very welcome in most offices.
    The Chairman. You had an armload of what?
    Mr. Ahari. Gifts.
    The Chairman. Gifts?
    Mr. Ahari. Gifts. Pardon me.
    The Chairman. Like what?
    Mr. Ahari. Pens, pads, clipboards, umbrellas on occasion, 
clocks, ballpoint pens, highlighters.
    The Chairman. Well, that was my second question. These 
pharmaceutical reps often come with considerable gifts.
    Mr. Ahari. Yes.
    The Chairman. Do you feel that the physicians look forward 
to this and some of the emollients that they get, and the gifts 
and the opportunities they get from the pharmaceutical reps, 
which I assume not be nearly what you are prepared to offer, 
because part of what they are doing is enticing? That is not 
what you do.
    So, why would they be so pleased to see you and deal with 
you, when the pharmaceutical reps they deal with oftentimes 
come with the kinds of considerations that are of great value 
to physicians?
    Mr. Ahari. I am sorry, Senator, can you reframe that 
question?
    The Chairman. Well, speaking engagements.
    Mr. Ahari. Oh.
    The Chairman. You are not offering speaking engagements. 
You are not offering meals. You are not offering trips. Right?
    Mr. Ahari. My.
    The Chairman. That is what they are offering--along with 
whatever information they are bringing, they are bringing 
things of value to physicians. Right?
    Mr. Ahari. Yes, Senator. Actually, I should clarify. I am 
not an academic detailer. I was formerly one of those slick 
salesmen. Now I am actually a researcher, detached.
    The Chairman. How you imagined this would work.
    Mr. Ahari. I see.
    Well, I have to confess. I think that there is a great deal 
of leverage that those gifts offer the sales reps. It gives 
them a great deal of capacity to actually get access to the 
physician. Again, there is the subconscious effect of actually 
persuading a physician to use a medication contrary to his 
training.
    The Chairman. So, do you see this impediment as being a 
significant one that has to be dealt with, if we are going to 
get academic detailing off the ground in a meaningful way?
    Mr. Ahari. Yes, sir, I do.
    The Chairman. Do you have any--yes, sir.
    Dr. Avorn.
    Dr. Avorn. Senator Kohl, if I can try to respond to that 
question. What we found over 25 years of doing this is that, 
while the academic detailers that we send out from Harvard 
don't come in with the armfuls of gifts that Mr. Ahari 
mentioned, what they do provide is something that is in a lot 
of ways much more precious to the doctor, once he or she 
figures it out. That is the ability to have the entire field 
summarized in a document and presented to them in their office 
in just 15 or 20 minutes.
    Over time, doctors learn that that is really a very 
valuable kind of emollient, to use your term, that is much more 
important than an expensive meal in a restaurant or a clock or 
a ballpoint pen. Once they get it, they realize that, you know, 
they can buy their own pens, but this is a kind of service that 
really makes them eager.
    We have had the experience of sales reps like the former 
Mr. Ahari, sitting in a doctor's waiting room from Lilly and 
Glaxo and Merck and Pfizer, and the doctor asking for our 
people to come in first, because they know that what they are 
going to get is pretty valuable in a clinical and in an 
intellectual sense, even if we don't bring a lot of goodies.
    Mr. Ahari. Senator, if I may coattail on that, actually, my 
experiences having lectured to 40 medical schools around the 
country actually echo Dr. Avorn's comments.
    I feel that once physicians are aware of the circumstances 
and the underlying nature of the relationship, they begin to 
appreciate the benefits of academic detailing, and recognize 
the potential conflicts of interest inherent in the physician-
pharma relationship. As it stands now, most physicians tend to 
either rationalize it or dismiss it.
    The Chairman. So, the two of you feel that the academic 
detailer can, in fact, surmount what is being brought to the 
table by the sales reps.
    Ms. Eisenhower, you have had this experience. What is your 
sense?
    Ms. Eisenhower. I think that doctors are hungry for this 
kind of information. When they get it, they are very pleased 
with it, and it changes the way they practice.
    We have a sense that, because the pharmacy promotion is 
really driven by bottom line profits, that it is not accurate. 
The doctors agree with that. They understand that. When you 
give them accurate information there is really a change in the 
way they prescribe for their patients.
    In addition to that, I told you that we were demonstrating 
this project. We are going to continue to operate this project 
in Pennsylvania and grow it.
    We are very pleased with the results. We thought there 
might be some pushback from doctors who resented the intrusion 
into their prescribing. We have had the opposite response. 
Doctors, as I said, are hungry for this. They are looking for 
the information.
    Dr. Avorn mentioned our detailers going to doctors' 
offices. They are welcome to those offices the second, the 
third and additional times.
    The doctors that we deal with, who are very active in the 
PACE program, treating seniors, are usually family physicians. 
So, what we see is the change in prescribing affects all of 
Pennsylvania programs, and all of their patients.
    So, we just think it is a wonderful program that we are 
going to continue to grow in Pennsylvania.
    The Chairman. You all apparently are saying that doctors 
are so busy that they can't really absorb all the products on 
the market, understand which is best, which is cheapest, which 
provides.
    Ms. Eisenhower. Senator, I don't think anybody can.
    The Chairman. No.
    Ms. Eisenhower. There is so much advertising out there for 
so many things in this country.
    The Chairman. They need to get information from somebody.
    Ms. Eisenhower. It is our responsibility. We are paying for 
the medications.
    We really jumped into the breach, because we felt that we 
were leaving the doctors out there without the data they needed 
to deal with our constituents, whether it is enrollers in PACE 
or a Medicaid recipient. We really needed to step up to the 
plate and do our job. That is where working with Harvard has 
been so effective.
    In addition to meeting with the doctor, the doctor gets 
continuing medical education credits. So, that is a real plus 
for them, because they have a mandatory requirement to meet 
through the year. The intervention that we do, unlike the sales 
representative, really does have some other benefit, other than 
educating the doctor.
    I think that has been a very positive aspect to it also.
    The Chairman. I have heard the panel. I don't know which of 
you said, for every $1 spent, there is $2 saved.
    Ms. Eisenhower. That is the minimum we have saved.
    The Chairman. What is that? In a year? Or over 5, or over 
10? Do you--how do you come to that estimate, Dr. Avorn.
    Dr. Avorn. Yes, that was based on our initial study that 
Mr. Coukell referred to. It was a randomized trial in four 
states in which we actually were able to look at what Medicaid 
spent on the prescribing by the doctors who were randomly 
offered this program, and doctors who were randomly assigned to 
be controls.
    Because we knew what it cost to run the program, since we 
were doing it, and we knew what Medicaid was spending, because 
we had all the paid claims tapes from these four states from 
their Medicaid programs, we simply totaled up the difference in 
expenditures by the doctors offered the program and the 
controls, and then divided that by what it cost to do the 
program.
    So, that is not an imaginary number. That was a real, 
observed number of $2 saved for every $1 spent.
    The Chairman. Yes, but isn't it.
    Dr. Avorn. On an annual basis.
    The Chairman. Oh, for on an annual basis.
    Dr. Avorn. Right.
    The Chairman. I see.
    Ms. Eisenhower. In addition, Senator, we didn't look at 
other programs that the same doctor was participating in. So, I 
think that savings would be magnified. I think over time, it 
will grow. I think we are going to show that in our programs.
    The Chairman. What kind of pushback do you imagine there is 
from the pharmaceutical industry? Do they love you all? Do they 
love your ideas?
    Dr. Avorn. Well, I think, compared to some of the scarier 
propositions that they face in policy terms, we are often seen 
as the lesser evil, in that it is voluntary for doctors, it 
preserves the doctor's freedom to prescribe whatever he or she 
wants. We don't get engaged in what people ought to pay for a 
given drug.
    It is really the provision of evidence from the medical 
literature to doctors on a voluntary basis.
    Given that the pharmaceutical industry at present is 
somewhere around the tobacco industry in terms of public 
mistrust, I think coming out against providing voluntary, 
evidence-based medicine to doctors is not a position that they 
are comfortable taking--at least in public.
    The Chairman. Mr. Carrejo.
    Mr. Carrejo. Senator Kohl, I might say they would embrace 
the effort, to the extent that they have a medication that 
would provide benefit. Medications like those, Fosinex, 
decrease the risk of hip fracture. To the extent that the 
medication provides no benefit, a molecule that is designed to 
extend patent, they might not so much embrace that effort.
    Those medications, I believe, are the low fruit for these 
types of efforts. So, you go out, and in 30 seconds to a 
minute, educate a prescriber about what that molecule delivers 
or does not deliver, and the same benefits could be procured 
from the use of a very inexpensive generic alternative.
    The Chairman. Senator McCaskill.
    Senator McCaskill. Thank you, Mr. Chairman.

         OPENING STATEMENT OF SENATOR CLAIRE MCCASKILL

    I appreciate you holding this hearing. I know that your 
work in trying to make public what drug companies and drug 
company reps are giving to doctors, and in terms of our 
registration bill, I think it is very important. I think this 
hearing further demonstrates the need to go further in terms of 
protecting the public--and frankly, after hearing the testimony 
and reading the testimony today, protecting the doctors.
    The doctors are not the bad guys here. The doctors didn't 
go into this line of work because they wanted to get pens and 
pencils--or trips, or free lunches. Doctors became doctors 
because they want to help people. They want to heal people.
    I think that what has happened here is, big, big money has 
invaded the marketplace and overwhelmed the doctors.
    I think one of the things I would like to talk about in my 
questioning is a rule, a draft guidance that was put out by the 
FDA in October. It is a startling change, potential change, in 
policy, considering the environment that we are operating in 
and all the testimony we have heard in this Committee over the 
months since I have been here.
    This draft guidance would overturn a half a century of FDA 
policy that prohibited the use of peer review journals in 
marketing off-label, non-FDA approved uses for drugs.
    Now, let me see if I get this straight. We have documented 
evidence that these peer reviews, some of these medical journal 
articles--first of all, we know that some of them have been 
paid for by the pharmaceutical companies. We know some of them 
have omitted important information that has, in fact, hurt 
people.
    What we are going to do now is say, you can take these 
studies, like the Vioxx study--I think, didn't Merck order more 
copies of the ``New England Journal'' article than there were 
doctors in the country?
    Dr. Avorn. Right.
    Senator McCaskill. I mean, I think they ordered up a 
million copies of it, didn't they?
    Dr. Avorn. Nine hundred thousand.
    Senator McCaskill. I am surprised they didn't mail it to 
every American, and say, you know, this is the gospel, this is 
the holy grail when it comes to Vioxx. Clearly, the ``New 
England Journal'' had to backtrack and apologize, and call the 
authors of that article out about their failure to present an 
unbiased view of Vioxx, because of the trials that had 
occurred.
    So, let me see if I understand this. We know that these 
journals have been problematic, some of these articles. The FDA 
is supposed to be approving use of these drugs. They are going 
to say, by the way, we haven't approved this, and you can use 
these articles to market the drugs.
    Now, I mean, we are talking about the wild, wild west 
already. Now what they have done is say, we are taking the 
sheriff out of town. I mean, if we have no sheriff, and it is 
the wild, wild west, what shot does the American consumer have, 
and doctors have, at finding the truth in terms of a factual, 
scientific basis on which to prescribe a drug?
    I would certainly, Dr. Avorn, like your reaction to this 
proposed--and what in the world would be motivating this rule 
change right now, unless it is pure profit-making by the 
pharmaceutical industry?
    Dr. Avorn. Senator McCaskill, you are absolutely right. As 
it turns out, my colleague, Aaron Kesselheim in my division and 
I have a paper on that very topic that will be in the ``New 
England Journal'' in the next couple of weeks, that essentially 
takes your view, but perhaps less eloquently.
    The worry that we have is that it really will become open 
season on doctors in terms of marketing, because there are a 
wide variety of papers, as your question implies, that are out 
there that may technically be in a medical journal, that are 
very biased or distorted views of the advantages or the safety 
of a given drug.
    FDA has, as you say, thus far held the line and said, if 
the drug has not been approved by the FDA for a given use, you 
can't promote it. That is about to change if this proposed rule 
goes through.
    There is an even greater concern around that very same 
topic, which is First Amendment challenges to the FDA's 
authority, which we are also seeing on kind of a parallel 
track. The First Amendment, of all things, is being used an 
argument that a company should have commercial free speech, to 
be able to say essentially whatever they want, as long as it is 
not fraudulent--outright fraudulent--about their products.
    At the same time that the industry has been working to have 
the rule that you described changed, they are also trying to 
demand that FDA should have no jurisdiction over what they can 
say, because of their free speech rights.
    With those two attacks going on concurrently, many of us 
are very worried that the doctor will really--and again, a 
doctor who may be working 12-hour days seeing patients, and 
going to the hospital and trying to fill out all the 
paperwork--the doctor is going to be easy prey for a slick 
person like Mr. Ahari's successors, to come in there and wave 
articles at them and say, well, this is not approved by the 
FDA, but get a look at this, this is a really use.
    It is very worrisome. You are absolutely right to be 
concerned.
    Senator McCaskill. Let me ask Dr. Avorn, do residency 
programs or medical schools now adequately prepare physicians 
for this very big problem that they are going to face when they 
enter the practice of medicine? Are they getting--in school--
are they getting cautioned about marketing versus science, and 
the differences between the two?
    Dr. Avorn. We are not doing a good enough job, either in 
medical schools or in residency programs.
    Ironically, just yesterday I was talking to the combined 
residencies of the Mass General Hospital and the Brigham 
Women's Hospital, all of their interns, to talk with them about 
this very issue. What was striking about that was what a rare 
event that was. This is normally not discussed, and many of us 
are trying to get this into medical school curricula.
    Interestingly, the Neurontin settlement of $430 million for 
off-label marketing of Neurontin, the attorneys general of all 
50 states took a small portion of that $430 million and set it 
aside as a program to support people in medical schools and in 
residencies to teach trainees about these very issues. I 
suspect that before the year is out, we may see an even larger 
Zyprexa settlement perhaps going in the same direction.
    So, there are some counter efforts, but it is not enough, 
and we don't do a good job as medical educators.
    Senator McCaskill. Is anyone policing, Mr. Ahari, the sales 
reps in terms of what they are saying and how they are saying 
it? Is there any fear that you ever had as a sales rep that 
something could happen to you if you pushed too hard or gave 
out information that was misleading or fraudulent to doctors' 
offices about the efficacy of the drugs that you were pushing?
    Mr. Ahari. No, Senator McCaskill. It is generally a self-
regulated policy within each industry.
    Quite frankly, the bottom line is the profit motive. You 
get a disconnect in terms of messaging as to what policies you 
are responsible for maintaining. But that is eclipsed by the 
general motivation for you to make bonus.
    Essentially, my only fears would arise if I had said 
something to a physician that I wasn't connected with, that I 
didn't have a friendship with, or if my sales techniques were 
failing on a general level and I wasn't going to make bonus. 
There would be enough plausible deniability for my manager to 
say that essentially, I had acted alone, independently, and it 
was my fault.
    But generally speaking, not only from my own experience, 
but speaking with other reps, there is great opportunity for 
managers to turn the other cheek when some gray area of 
business is occurring, if it helps the territory, if it helps 
the bottom line.
    Senator McCaskill. Well, I mentioned in this Committee 
before that, unbeknownst to the people around me--I was on an 
airplane from St. Louis to Chicago, and I was surrounded by 
about 30 or 40 drug reps going to a meeting in Chicago of their 
company.
    First of all, I felt very old, because they were all very 
young. I also felt very fat, because they were all very 
physically attractive. [Laughter.]
    The chatter and the banter between them as they talked 
about their work, I think would be frightening to any consumer 
who understood what it was they were talking about.
    I mean, one was actually giving great trouble to the other 
one saying, well, you know, easy for you to say. You have got 
shrinks. [Laughter.]
    Referencing, obviously, that psychiatrists prescribe drugs 
to literally every patient they see--almost. I mean, maybe 
there might be an exception. I don't know. Dr. Avorn, you might 
speak to that better than I certainly could, because I have no 
medical training.
    But it was--you know, it was really unsettling to listen to 
them talk about this, as if they were selling widgets as 
opposed to medicine.
    I think that we have got to take every step we can within 
the constitutional limitations we have to help doctors get this 
good information. I think the program that is in Pennsylvania, 
I am going to talk to the people in Missouri. Having done a lot 
of audits as the State auditor on Medicaid, you know, we were 
at a point in Missouri where we weren't even using a formulary 
in Medicaid.
    We had a huge OxyContin problem within the Medicaid 
population, because of doctor-shopping. They hadn't even done 
the basics in terms of controlling an obviously wildly 
addictive drug like OxyContin. So I know we have so much work 
to do in terms of public dollars being spent.
    I think piloting these programs with public dollars makes 
such good sense, because then the doctors begin to realize, 
there is a better way to get the information they need to do 
what is right for their patients.
    Ms. Eisenhower. I think you are right. I think it comes 
from a trusted source, for the most part.
    Senator McCaskill. Right.
    Ms. Eisenhower. We do get some complaints about government 
when we first get out to speak to doctors.
    Senator McCaskill. That happens to all of us in government.
    Ms. Eisenhower. It is a good thing. Eventually, the 
relationship that is built on trust really recognizes that the 
bottom line motivation is not profit-driven, and that is not 
appropriate in the setting. I think that is what makes the 
relationship positive and flourish and grow, and makes the 
doctor able to take that information and use it for all of his 
or her patients.
    Senator McCaskill. I would ask finally, Mr. Chairman, if 
there are any suggestions that any of you have about what 
government could do appropriately. I know there is a lot of 
talk about what would be inappropriate for government to do in 
this area.
    What, if you have ideas about what government could be 
doing, other than the pilot program that is being done through 
the State expenditures of funds for medicine and the academic 
detailing, is there anything we could do to go--and the 
registry that we have proposed in terms of exposing the kind of 
freebies that are given to the prescribing doctors--is there 
anything else that we could be doing that you can see, that 
would be helpful?
    Mr. Carrejo. I think the two components--don't forget about 
the evidence, because no matter how good our academic detailers 
are, when they get in that office, if it is not evidence-based, 
it is not going to fly. So, the efforts that this Committee is 
already financing and ensuring that there is good comparative 
trials.
    I think the primary problem with those drugs that are on 
the market today--and you speak of going off-label, but just 
those labeled drugs--they are compared only to placebo. So, 
really, fortunately, I am not the marketer for the drug 
companies, because what I would come up with is something like, 
``We are better than nothing,'' in my ad, you know. [Laughter.]
    So, the evidence needs to.
    Senator McCaskill. Somehow, I don't think they are going to 
use that one.
    Mr. Carrejo. I had better keep my day job? [Laughter.]
    Senator McCaskill. I think you had better keep your day 
job.
    Mr. Carrejo. So, the evidence definitely needs to be there, 
and we are doing some great work there, some early great work. 
But we need to continue financing that, and getting good 
academic detailers out there to get that message, including 
physicians, not just pharmacists, but within Kaiser, having key 
opinion leaders from that specialty--for the COX-2s it is 
rheumatologists, for the statins it is cardiologists--to carry 
that message out, much like the drug companies do.
    Mr. Coukell. Senator, I would echo that comparative 
effectiveness is important. The Physician Payments Sunshine Act 
that you and Senator Kohl have introduced is important. There 
are probably next steps, once we know the flow of marketing 
dollars to physicians. There are questions about what other 
organizations are those marketing dollars going to that might 
help advance this?
    As we look to the medical profession, the professional 
medical associations and the medical centers, there are 
certainly leaders in many organizations who are trying to take 
responsibility for the profession, and clean it up and put 
these relationships on a sounder ethical footing.
    I think attention from committees like this helps those 
leaders drive that agenda within their profession.
    Dr. Avorn. In thinking about how government might 
facilitate this, at least on the academic detailing side, there 
are three distinct components. One is the very important issue 
that Mr. Carrejo mentioned about we need the data.
    We need to not rely on the drug companies to conduct and 
pay for and evaluate all the studies, pre-approval or post-
approval. We need to have publicly funded clinical trials that 
compare one drug against another.
    While those may cost something to do, when you consider how 
many billions we are spending per year of government money on 
drugs that are no better than alternatives, those are dollars 
that would pay themselves back within the space of a year, at 
most.
    The second piece, having generated the data, is to put it 
in a format that is user-friendly. That is a difficult task. It 
is one that we spend a lot of time worrying about, because one 
of the real strengths of the companies is that they can 
condense information--very selectively, but they condense it--
into something that is actually readable and engaging. That is 
a piece of work that builds on the evidence.
    Senator McCaskill. It is hard for you academics, isn't it.
    Dr. Avorn. It is, exactly. It goes against all of our 
instincts. But we also know that, you know, when in doubt I 
say, what do the drug companies do. We try to replicate at 
least half of what they do--not the other half.
    Boiling information down into an actionable and user-
friendly mode is an important second piece.
    Then the third piece is just paying the staffs that will be 
going out there, which could be done, probably not on a Federal 
level, but perhaps having regional competitions to see whether 
it is a medical school or a school of pharmacy or a medical 
society in a given State or region that might want to do this 
program.
    Then, my last thought, unrelated to academic detailing is 
government needs to fix the FDA. The Institute of Medicine 
report, the GAO report, the FDA's own Science Board report, 
make it clear that the FDA is broken and it badly needs to be 
repaired. That is another important function of government.
    Senator McCaskill. Thank you, Mr. Chairman.
    The Chairman. Thank you. Thank you, Senator McCaskill.
    These academic detailers--who are they? Where do they come 
from? What kind of training do they get? How much do they get 
paid? How can what they get paid compete with the amount of 
money that the sales reps probably make, which is a multiple of 
what these academic detailers make?
    Wouldn't the best ones be enticed at some point to go off 
and make twice or three times as much as sales reps?
    Ms. Eisenhower. Well, Senator, I would like to start 
describing that, and then I would like to turn it over to Jerry 
Avorn, who works daily with our detailers in Pennsylvania.
    I think that the assumption is that everyone in the country 
is profit driven. But we can see from our earlier testimony 
that many of the detailers who work with us--well, at least 
some of them--have come over from the dark side.
    I think, in addition to that, what we see is that there is 
such a rewarding sense of the work that they are doing and on 
how effective it is, that they are really pretty satisfied. I 
don't think we will lose many of them.
    But the details--the other thing I do want to say is we 
don't have a cheerleader in the bunch. At least not yet. But I 
think Jerry is working on that.
    Dr. Avorn. No, only if they are a pharmacist or a nurse who 
happens to be a cheerleader.
    As Secretary Eisenhower mentioned, we seek to hire people 
who start out as nurses or pharmacists already, and have got 
really solid clinical training, which, as Mr. Ahari mentioned, 
is not a requirement on the industry side.
    We pay them less than people in the industry pay. We pay 
them 50 bucks an hour. That is--they can make much more than 
that working for the drug companies.
    But as Nora said, I guess working in the university my 
whole life, I am surrounded by people who are willing to not 
get paid the big bucks, because they are doing something that 
they love and that they think is important.
    Also as Nora said, we do have some of our most valuable 
people in the Pennsylvania program used to be pharmaceutical 
company sales reps, although they also happen to be pharmacists 
or nurses.
    What they tell me is that they really welcome the 
opportunity to use all their knowledge in an evidence-based, 
neutral way, without having a particular party line or sales 
pitch that they have got to offer, and to acknowledge there is 
ambiguity here--this is not so clear, this seems to be the case 
for these drugs--and to be able to really use their skills. 
That seems to make up for them the fact that they don't get 
paid what pharmaceutical sales reps or what they were paid back 
when they were working for industry, because there is more to a 
job than what you get paid.
    Mr. Ahari. If I may add, there is a high attrition rate 
with pharmaceutical sales reps. They tend to last about an 
average of 2 years. I think a fair amount of that is due to the 
ethical dilemmas they encounter, and the golden handcuffs are 
no longer strong enough to bind them to the job.
    The Chairman. So I take it you are rather unanimous in your 
opinion that, if we as a country somehow--whether it be at 
State-funded or Federal-funded level--spent the amount of money 
that would be necessary to get these people lined up, trained 
and out in the field talking to physicians all across the 
country, that in your opinion, without any question, there 
would be a huge multiple of savings in the pharmaceutical cost 
industry to the taxpayer.
    Is that right?
    Ms. Eisenhower. Absolutely, Senator. I mean, usually when 
we come forward here we might have a few pros and cons. But I 
just don't see any cons in this. It has been an enormously 
positive thing and long overdue.
    The historic enactment of Medicare Part D, I think it is a 
real opportunity to step up and Federalize this kind of work.
    The Chairman. Senator McCaskill, do you have any closing 
comments?
    Senator McCaskill. I don't. Thank you all for being here.
    Mr. Ahari. May I add one more comment?
    The Chairman. Go right ahead. I am sorry.
    Mr. Ahari. Again, to coattail on Secretary Eisenhower's 
comments, the average sales rep working for industry returns 
about $10 for every $1 invested. If academic detailing is only 
a fraction as effective, it will yield dividends for public 
health. I am fairly certain that it is more than just a 
fraction as effective.
    Thank you.
    Dr. Avorn. I guess the last point I want to make is that, 
what we also really care about is the quality of care that our 
patients get. Ironically, one can deliver care that is as good 
or even, often, much better at a fraction of the cost. That is 
true of the whole health care system, but it is certainly true 
of pharmaceuticals.
    As Mr. Carrejo mentioned, a program that said don't use so 
much Vioxx, we now know, not only saved tons of money for 
Kaiser, but also prevented a lot of people from having Vioxx-
induced heart attacks and strokes.
    By going with the evidence and our experience, you both 
save money and you improve the quality of care.
    The Chairman. Great. Any other comments, information, 
thoughts, ideas?
    Dr. Avorn. We just applaud you for moving this agenda 
forward.
    The Chairman. Yes. We thank you all for coming. It has been 
a great hearing. With that, the Committee is adjourned. 
[Whereupon, at 11:39 a.m., the Committee was adjourned.]
                            A P P E N D I X

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