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45–474 PDF 2008

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 

SPECIAL COMMITTEE ON AGING 

HERB KOHL, Wisconsin, Chairman 

RON WYDEN, Oregon 

BLANCHE L. LINCOLN, Arkansas 

EVAN BAYH, Indiana 

THOMAS R. CARPER, Delaware 

BILL NELSON, Florida 

HILLARY RODHAM CLINTON, New York 

KEN SALAZAR, Colorado 

ROBERT P. CASEY, Jr., Pennsylvania 

CLAIRE McCASKILL, Missouri 

SHELDON WHITEHOUSE, Rhode Island 

GORDON H. SMITH, Oregon 

RICHARD SHELBY, Alabama 

SUSAN COLLINS, Maine 

MEL MARTINEZ, Florida 

LARRY E. CRAIG, Idaho 

ELIZABETH DOLE, North Carolina 

NORM COLEMAN, Minnesota 

DAVID VITTER, Louisiana 

BOB CORKER, Tennessee 

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) 

(1) 

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 

2 

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. 

3 

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. 

4 

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. 

5 

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. 

17 

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 

18 

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 fullscale 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 

23 

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 

24 

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-tophysician 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-efVerDate Aug 31 2005 11:17 Dec 02, 2008 Jkt 000000 PO 00000 Frm 00037 Fmt 6633 Sfmt 6633 H:\DOCS\45474.TXT SAG PsN: JOYCE
34 

fective. 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. 

39 

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. 

46 

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. 

47 

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. 

48 

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 offlabel, non-FDA approved uses for drugs. 

49 

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. 

50 

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 offlabel 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. 

51 

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 

52 

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. 

53 

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. 

54 

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 Statefunded 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. 

55 

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.] 

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