[Senate Hearing 110-253]
[From the U.S. Government Publishing Office]
S. Hrg. 110-253
PAID TO PRESCRIBE?
EXPLORING THE RELATIONSHIP BETWEEN DOCTORS AND THE DRUG INDUSTRY
=======================================================================
HEARING
before the
SPECIAL COMMITTEE ON AGING
UNITED STATES SENATE
ONE HUNDRED TENTH CONGRESS
FIRST SESSION
__________
WASHINGTON, DC
__________
JUNE 27, 2007
__________
Serial No. 110-10
Printed for the use of the Special Committee on Aging
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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, Staff Director
Catherine Finley, Ranking Member Staff Director
(ii)
C O N T E N T S
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Page
Opening Statement of Senator Herb Kohl........................... 1
Panel I
Jerome Kassirer, M.D., distinguished professor, Tufts University
School of Medicine, Boston, MA................................. 3
Greg Rosenthal, M.D., retinal specialist, Toledo, OH............. 12
Peter Lurie, M.D., MPH, deputy director of Public Citizen's
Health Research Group, Washington, DC.......................... 19
Sharon Treat, state representative, executive director, National
Legislative Association on Prescription Drug Prices, Hallowel,
ME............................................................. 30
Panel II
Robert Sade, chair, Council on Ethical and Judicial Affairs,
American Medical Association, Washington, DC................... 52
Marjorie Powell, Esq., senior assistant general counsel,
Pharmaceutical Research and Manufacturers of America,
Washington, DC................................................. 61
APPENDIX
Dr. Kassirer's Responses to Senator Kohl's Questions............. 87
Dr. Rosenthal's Responses to Senator Kohl's Questions............ 89
Peter Lurie's Responses to Senator Kohl's Questions.............. 127
Rep. Sharon Treat's Responses to Senator Kohl's Questions........ 128
Marjorie Powell's Responses to Senator Kohl's Questions.......... 133
Statement from the American College of Physicians................ 142
Testimony of Anthony Fleg, American Medical Student Association.. 146
Statement of Lewis Morris, Chief Counsel to the Inspector
General, Office of the Inspector General, U.S. Department of
Health and Human Services...................................... 168
Testimony submitted by the National Physicians Alliance.......... 175
(iii)
PAID TO PRESCRIBE? EXPLORING THE RELATIONSHIP BETWEEN DOCTORS AND THE
DRUG INDUSTRY
---------- --
WEDNESDAY, JUNE 27, 2007
U.S. Senate,
Special Committee on Aging,
Washington, DC.
The Committee met, pursuant to notice, at 10:39 a.m., in
room SD-106, Dirksen Senate Office Building, Hon. Herb Kohl
(chairman of the committee) presiding.
Present: Senators Kohl, Carper, and McCaskill.
OPENING STATEMENT OF SENATOR HERB KOHL, CHAIRMAN
The Chairman. Hello to one and all, and we will call this
hearing to order at this time.
Today, we look forward to examining the financial
relationship between the pharmaceutical industry and
physicians. Interactions between doctors and drug manufacturer
representatives often involve payments that can actually take
the form of cash and gifts, such as meals, travel to
conferences, or textbooks.
Unlike other professions, physicians are allowed to take
payments from companies whose products they may choose to
prescribe to their patients. Recent studies show that the more
doctors interact with drug marketers, even through small gifts
and modest meals, the more likely doctors are to prescribe the
expensive new drugs that are being marketed to them when a more
affordable generic would do just as well.
Seniors lose out with unnecessarily high drug costs while
doctors and drug manufacturers benefit financially. The rising
drug prices don't only harm the elderly. They hurt us all, as
they undermine our private and public health systems.
Health insurance premiums continue to skyrocket, and
escalating drug costs have played a large role. The Federal
Government, now the largest payer of prescription drugs with
the new Medicare drug benefit, feels the squeeze as well, and
considerably.
Even more alarming, these gifts and payments can compromise
physicians' medical judgment by putting their financial
interest ahead of the welfare of their patients. Over the last
several years, there have been attempts by the Federal
Government, medical organizations, and drug companies to curb
the excessive gifts and payments to physicians.
Unfortunately, as we will hear from some of our witnesses
today, financial ties between doctors and drug companies are
only deepening. In fact, a study published in the New England
Journal of Medicine earlier this year reported that 94 percent
of physicians have received food and beverages, medication
samples, and other gifts, as well as payments for trips, from
drug companies.
The pharmaceutical industry remains one of the most
profitable industries in the world, returning more than 15
percent on their investments, which is extraordinary. As a
businessman myself, I fully respect an industry's right to
maximize profits.
Nevertheless, I believe they are charging Americans--and it
is a fact--the highest drug prices in the world, forcing some
employers to drop health coverage for their employees,
squeezing budgets of State and Federal Governments and,
ultimately, harming our seniors by putting drug costs out of
their reach.
It has been estimated that the drug industry spends $19
billion annually on marketing to physicians in the form of
gifts, lunches, drug samples, and sponsorship of education
programs. Companies certainly have the right to spend as much
as they choose to promote their products, but as the largest
payer of prescription drug costs, the Federal Government has an
obligation to examine and take action when companies unfairly
or illegally attempt to manipulate the market.
Today's witnesses will discuss the current state of the
physician-drug industry relationship, recent attempts at the
state level to increase disclosure of payments, and attempts to
reduce the influence of the drug industry on physicians'
prescribing behaviors. We will also hear testimony from one
doctor who feels that these potential conflicts of interest
have reached a disturbing level in his profession and is
adversely affecting medical research.
Our second panel will include representatives of the
pharmaceutical industry and the medical profession, and they
will provide us insight into their voluntary guidelines
addressing physician gifts and payments. We look forward to
hearing from each of our witnesses in terms of their
perspectives on this issue and their recommendations.
Obviously, we take this issue very seriously, and we will
continue oversight of the relationship between doctors and the
drug industry. While there are voluntary guidelines already in
place, to us it seems clear that they are not being
sufficiently followed. We intend to vigorously pursue stronger
adherence to these guidelines, as well as to propose a national
registry to require disclosure of payments and gifts.
I believe we need transparency at the minimum and at the
outset. Many of these gifts are not illegal, but we need them
disclosed. These interactions involving things of value between
the pharmaceutical industry and doctors, in our judgment, need
to be made public.
So we thank you all for being here today.
At this point, I will introduce our first panel.
Our very first witness today will be Dr. Jerome Kassirer,
who is a distinguished professor of medicine at Tufts
University. Dr. Kassirer has published numerous original
research and clinical studies regarding quality health care,
and he served as the editor-in-chief of the New England Journal
of Medicine from 1991 to 1999.
After that, we will hear from Dr. Greg Rosenthal, the chief
of ophthalmology at Toledo Hospital and Toledo Children's
Hospital and the director of retina care at Vision Associates
in Toledo. He has extensive training in all diseases and
surgery of the retina, and he serves on several national
committees with respect to eye health.
Our third witness today will be Dr. Peter Lurie, who is the
deputy director of Public Citizen's Health Research Group, a
consumer advocacy group here in Washington, DC. Dr. Lurie has
worked on a myriad of issues related to pharmaceutical policy,
including the cost and safety of prescription drugs.
Our fourth witness on the first panel will be State
Representative Sharon Treat. She is a member of the Maine
legislature, where she has served for nearly 15 years,
including two as Senate majority leader. Representative Treat
is also executive director of the National Legislative
Association on Prescription Drug Prices.
So we welcome all of you here today, and we look forward to
your testimony.
Dr. Kassirer, we will start with you.
STATEMENT OF JEROME KASSIRER, M.D., DISTINGUISHED PROFESSOR,
TUFTS UNIVERSITY SCHOOL OF MEDICINE, BOSTON, MA
Dr. Kassirer. Thank you, Mr. Chairman.
As you heard, I am Jerome P. Kassirer. I am a distinguished
professor at Tufts University School of Medicine in Boston and
visiting professor at Stanford University. I am a former
editor-in-chief of the New England Journal of Medicine and
author of the Oxford University Press book, ``On the Take: How
Medicine's Complicity with Big Business Can Endanger Your
Health.'' I represent no institution and no medical
professional organization.
I have been asked to provide a brief overview--actually,
you did it pretty well already--of the complex intertwining of
the medical profession and the pharmaceutical, biotechnology,
and device industries and the consequences of these
relationships.
I will assert that the medical profession has become
excessively dependent on the largest of industry, that these
financial connections have a negative influence on the quality
and cost of patient care and the trust of the public, and that
the profession's response to these threats has been inadequate.
American doctors train for many years, and many accumulate
substantial debt to become physicians. They then work long
hours, struggling in a complex health care delivery system to
reduce the burden of illness.
There is no other country where I would prefer to get care
for my family or myself. Our physicians, hospitals, medical
centers, and medical professional organizations are respected
around the world.
In the same vein, the pharmaceutical, biotech, and device
industries have revolutionized clinical practice by developing,
often with the help of academic physicians, new diagnostic
tools, prostheses that improve day-to-day living, and life-
saving medications.
The companies are also a vigorous engine that accounts, in
part, for our country's phenomenal economic growth. But these
companies require big profits, and, to do so, they mount
massive marketing campaigns, much of it directed at doctors.
Doctors are human and, like the rest of us, they respond to
financial incentives.
I need not remind any of you what a struggle it has been to
eliminate physician self-referral of patients to their
personally owned health care facilities. But the extent of
self-referral pales compared with the enormous financial
incentives generated by these industries.
The magnitude of drug promotion astonishes, as 100,000 drug
reps visit doctors, residents, nurses, and medical students
every day and ply them with free gifts, meals, and gadgets.
Medical meetings are mini-circuses, replete with enormous
glittering displays and hovering attractive personnel. Although
couched as education, these marketing efforts are thinly
disguised bribes.
Just as surprising is the magnitude of physician
involvement with industry. As you pointed out a few minutes
ago, among a random sample of doctors reported just weeks ago
in the New England Journal of Medicine, more than three-
quarters had taken free samples, free food, and free tickets to
sporting events from industry; more than one-third accepted
free continuing medical education; and another third had
received payments for speaking or consulting for the companies
or enrolling patients in clinical trials.
Some have estimated the industry's total advertising bill
at $70 billion. There is nothing fundamentally wrong with
advertising products, but when financial incentives yield
inappropriate or dangerous care, when they inordinately raise
the cost of care, when they risk patients' lives in clinical
trials, and when they damage the profession, they have gone too
far.
We need not look back very far. Only 2 weeks ago, the New
York Times reported that drugs were being selected for cancer
patients depending on the profit they would achieve for a
medical practice. The same week, we read a study that showed
that sponsorship of controlled trials of statins was closely
correlated with positive results of such trials.
Three weeks ago, we learned that payments for enrolling
patients in clinical trials were leading to shabby research
practices by unqualified researchers. This spring, we learned
that physicians with financial ties to the company that makes
Epogen were inappropriately represented on a National Kidney
Foundation committee that recommended potentially dangerous
doses of the drug.
These recent revelations are just a continuation of reports
over the past 10 years or so. Dozens more are detailed in my
book.
Financial payments have swayed professional medical
organizations to make inappropriate clinical recommendations.
They have influenced industry-paid speakers to recommend risky
drugs. They have biased FDA panels and yielded inappropriate
behavior by NIH scientists.
Free drug samples encourage doctors to use the newest and
most expensive drugs, and the samples themselves often get into
the wrong hands. Drugs such as Natrecor, approved for acute
heart failure only in the hospital, found widespread use in
doctors' offices, costing taxpayers hundreds of millions of
dollars.
What have leaders in the profession done to counter a trend
in which the profession has become increasingly beholden to
industry? Not much.
The American Medical Association and many other physician
organizations permit their members to receive gifts and meals
and to serve on pharmaceutical companies' speakers bureaus.
Most of them have no proscription against members' involvement
as consultants to industry for marketing or for the development
of educational materials. In fact, most medical society rules
are no more stringent than those of PhRMA.
Last year, my colleagues and I recommended conflict-of-
interest policies for academic medical centers. We proposed
that industry-paid gifts and meals be eliminated; that faculty
should not join industry speakers bureaus; that all faculty
consulting with industry be strictly overseen by contract; that
drug formulary committees be free of conflicted physicians; and
that free drug samples be regulated by a voucher system.
Since then, a number of medical centers, including
Stanford, Penn, Yale, and U.C.-Davis, have revised their
policies along these lines, but most of them have picked off
the low-hanging fruit, proscribing visits by drug reps and
eliminating industry-supported meals. None of them has
eliminated faculty involvement on speakers bureaus or
consultations on marketing issues.
Doctors are at risk of corruption from the perverse
incentives from industry. I prefer that the profession police
itself, but in the 3 years since publication of my book,
progress in extricating medicine from industry influence has
been minimal.
Newspaper reports and State reporting requirements have not
been sufficient. I would like to see a Federal registry for
reporting analogous to those of some States. I would also like
to see a congressional mandate to the Institute of Medicine of
the National Academy of Sciences for studies that mirror those
that called attention to medical errors.
We must put more pressure on both the profession and the
industry. In my opinion, both have reneged on their ethical
responsibilities for the care of the sick.
Thank you, Mr. Chairman.
[The prepared statement of Dr. Kassirer follows:]
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The Chairman. Thank you so much for your testimony.
Mr. Rosenthal.
STATEMENT OF GREG ROSENTHAL, M.D., RETINAL SPECIALIST, TOLEDO,
OH
Dr. Rosenthal. Thank you very much. I am Dr. Greg Rosenthal
[off-mike]--I am having microphone problems.
Is that better?
The Chairman. That is good.
Dr. Rosenthal. OK. I have a number of leadership positions,
and I am also a co-founder of Physicians for Clinical
Responsibility, or PCR.
We are living in an age of pharmaceutical influence, where
companies sponsor physicians, medical research, and clinical
decisionmaking. Pricing of retinal pharmaceuticals is such that
one agent could cost CMS as much as the entire eye care budget,
so the motivation to control this market is strong.
Such influence is inappropriate when it serves company
interests at the expense of patient and societal interests. In
the retinal field, this is a particular threat to seniors due
to the prevalence of macular degeneration and diabetic
retinopathy common in this group.
There is a schism in the retina community between the
majority who want to do legitimate research and patient care
and a strategically cultivated group of doctors willing to help
corporate interests in exchange for valuable consideration.
Drug companies exert control by controlling drug trials and
linking them to marketing efforts; nurturing key opinion
leaders, or KOLs, to influence medical decisionmaking;
providing money, travel, and publicity for community doctors
when they agree to promote certain products; funding
professorships and other academic needs of those who support
company interests; using unrestricted grants to influence
journals, societies, meetings, and Web sites; controlling
speakers and presentation of CME courses and materials; and
creating bogus expert panels to promote products and
treatments.
Physician opposition to this complicity is growing and
summarized in a recent quote from Dr. Jerry Sebag, a leader in
our community. He writes, ``It is becoming increasingly obvious
to me that many speakers on the AMD circuit, the so-called
experts, are puppets serving their needs and the companies that
pay them. While many of us may not be 'key opinion leaders,' we
are 'key care leaders,' and as such, it is up to us to promote
the interests of our patients and society at large.''
The influence of Big Pharm, as we call it, is pervasive.
Research used to be independently funded and designed, but with
the decrease in public funding, drug companies have moved in
aggressively. The independent trials have been replaced by
corporate-sponsored RCTs, or randomized control trials.
Although bias in such trials has been well-documented,
companies have, largely through their KOLs, promoted the idea
that only sponsored data is valid, and there is growing
pressure to ignore any non-CSRCT data. Either through financial
inducement or fear tactics, many physicians are persuaded to
comply. There have also been efforts to block studies and
ignore data that might conflict with CSRCTs.
In redefining the RCT, pharmaceutical companies are
exerting control over what to study, which questions to ask or
not ask, IRB independence--that is, Institutional Review Board
independence--what to report or not report, and the
presentation of the data. Drug companies also tightly
coordinate their studies with their marketing plans.
Researchers are recruited, some with conflicts of interest
ranging from excessive cash to stock options and lab and
professorship funding. Some of these same doctors are then
cultivated as key opinion leaders and are further compensated
to promote the company's message. I recently spoke with an M.D.
employed by a major drug company whose actual title was
``Thought Leader Liaison'' and whose job was to recruit and
tend to the KOLs.
Even good research is tainted by the possibility of bias,
and it is very difficult to know what and what not to believe.
We recently declined participating in a study of a promising
drug simply because the study was so laden with perks for
doctors that participation would have begged unavoidable
questions about the credibility of our work.
Drug companies also work at the community level. Doctors
whose only qualification is that they use a product are
recruited and paid to do studies or sit on ``expert panels''
and travel to exotic destinations to discuss, that is, promote
products. Invitations to nominal scientific advisory boards are
made on a similar basis.
Retina doctors often complain that society meetings have
lost credibility since almost every speaker is compromised by
financial relationships. These same meetings serve as little
more than preliminaries for after-hours seminars, usually in
luxurious hotels where doctors can receive CME credits, meals,
and often gifts for listening to the sponsor's spin on standard
care.
Societies and medical journals have become dependent on
unrestricted grants from numerous pharmaceutical companies. In
this context, ``unrestricted'' means, ``Use this for whatever
you want, but if you ever want another one, don't displease
us.''
As an example, last year, I wrote an op-ed criticizing
conflicts of interest, and although it was hailed by several
retina leaders as ``right on the mark, very important, and the
right thing to do,'' it was proved unpublishable. Several
journal editors praised the article but indicated that they
could not publish it, due in part to concern about advertisers
and the reviewer's relationships with the pharmaceutical
companies.
None of these concerns was put in print. One editor even
suggested that I ``shouldn't take this on.'' Another time, I
was to speak on this topic, but 5 minutes before the talk, I
was asked to change topics because the society had just
received a large sponsorship check from a drug company.
Physicians face a difficult choice. One path is to go
along. With drug company money, you can increase your income,
prestige, build your practice, or fund a department, research,
or professorships. The middle ground is to simply look away.
The hard choice is to fight back. The road back to
credibility is long. Opposing forces are well-funded and well-
motivated. Still, there are many, many retinal specialists who
are disturbed by the slide of our profession. The formation of
PCR is a first step.
Current dynamics will continue to permit uncontrolled
compromise of the public welfare for personal or corporate
gain. The system needs to be changed in response to this
extreme opportunism. Dr. Kassirer, Dr. Marsha Angell, and
others have outlined steps that can be taken to restore the
independent practice of medicine.
The majority of physicians desire to practice honest
medicine in their patients' and in society's best interests,
and these doctors would welcome any changes that would mitigate
financial conflicts and restore credibility to our research,
our education, and our practice of medicine.
Thank you very much.
[The prepared statement of Dr. Rosenthal follows:]
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The Chairman. Thank you, Dr. Rosenthal.
Dr. Lurie.
STATEMENT OF PETER LURIE, M.D., MPH, DEPUTY DIRECTOR OF PUBLIC
CITIZEN'S HEALTH RESEARCH GROUP, WASHINGTON, DC
Dr. Lurie. Good morning, Senator. Thank you for inviting me
to speak.
I have brought along the people who helped me prepare this
testimony, who are able to take any more detailed questions you
might have.
I am here to talk about the State laws that require
disclosure of gifts from drug companies to doctors, and let me
start with my conclusion.
What we really need is a national law. We have a minority
of States that have laws, and as I will show, those laws are
riddled with holes and poor enforcement. So I think your idea
and that of Senator Grassley to move forward with a national
reporting law is spot-on.
The laws are on the ascendancy. The Minnesota statute dates
from 1993, but nobody took any further action on this until
2001. But since then, we have seen three States and D.C. that
have enacted similar laws. Eleven States thought about imposing
them in 2006, but none of them, to our knowledge, became law.
The drug industry estimates that it spent $25.3 billion in
2003 on marketing. The doctors think that they are exempt from
this. They think they are unaffected by such interactions. But
it seems unlikely that pharmaceutical companies would be
catering to the culinary and travel preferences of doctors if
they didn't think that they were getting some bang for the
buck.
The evidence, as reviewed by Dr. Kassirer in his written
testimony, strongly suggests that the drug companies are right.
There are multiple studies showing an impact upon changes in
prescribing of doctors, upon their early adoption of new
medications which themselves might be hazardous, and changes in
formularies, all of them the result of interactions with drug
representatives, with all-expenses-paid travel to various
exotic locations and the like.
The companies, therefore, have a clear conflict of
interest, and yet we have surrendered the marketplace to them
by allowing them to influence physicians. The result can be
prescribing that is based on marketing instead of on science.
Patients are the victims of all this.
The physician disclosure laws are just one of many ways
that we might go about trying to limit the damage of this
marketing, and we have already seen the benefits of these laws.
We published our article in the JAMA back in March, and in
Minnesota, there have been already at least four positive
results: firstly, an undertaking by the executive director of
the Minnesota Board of Pharmacy to actually put the data up on
the Internet. Although, when I last looked, it actually wasn't
there.
Several clinics contacted us, alarmed that physicians in
their employ were taking money in such large amounts from drug
companies and they had been unaware of it.
There were two important articles in the New York Times,
the first of which identified physicians who had been used by
pharmaceutical companies to run clinical trials, even though
they had long records of discipline from the Minnesota Board of
Medical Practice, and another which documented particularly
large payments to the thought leaders to which Dr. Rosenthal
just referred.
My testimony has two parts, and the first is a review of
existing State physician payment disclosure laws. We, for this
testimony, conducted a detailed analysis of five State laws
which are currently in place, and they are summarized in a
table on page 3 of my testimony and in more detail in an
appendix.
What we learned was that none of the statutes requires
device or biologic manufacturers to report payments, and I
think that will be the first error to correct. Two of the five
States do not require separate reporting of each payment,
permitting various forms of data aggregation and the loss of
important detail. In West Virginia, you don't even have to
report the name of the physician, so that is a particularly
weak statute.
Exclusions from reporting are common. The threshold for
reporting ranges from $25 to $100. Four States exempt certain
payments related to medical conferences and research studies
from the reporting requirement, and all exempt free samples for
patients, even though most studies show that the samples are,
in fact, the largest expenditure for the pharmaceutical
companies when it comes to marketing.
We don't think that these exclusions are justified, as long
as each payment is clearly identified as having a particular
purpose. We think that researchers, patients, and congressmen
are able to look at these particular payments and make
decisions for themselves as to whether or not they think they
are appropriate. Only the Minnesota statute makes all of the
disclosed information part of the public record without
exception, although the four remaining States do require annual
summary reports to the legislature.
Now I want to turn to the second part of my testimony, to
the paper that we published in the JAMA relating only to
Vermont and Minnesota, which are the only two that are actually
in place right now. In both States, payment disclosures can be
obtained, but you really have to run through the hoops in order
to get them.
In Vermont, we had to enter into extensive negotiations
with the attorney general's office and submit simultaneously an
Open Records Act request. It took 12 months before we got any
of this information, and even then, 30 of the 68 companies in
the most recent year designated at least some of their payments
as trade secret, and, as a result, all of those records were
withheld.
Subsequently, we initiated a lawsuit against the attorney
general, and most of the companies have now settled with us,
providing some form, often of redacted data, but some data at
least, but setting no precedent for release to others.
In Minnesota, the data are easier to find but harder to
use. You have to make a trip to Minneapolis to the office of
the Minnesota Board of Pharmacy, and there you will find a
bunch of boxes gathering dust because no one has bothered to
open them for the last several years, let alone enter them into
a database.
So they are there for you. You pay to photocopy them. We
did that and then entered them into a database for our study.
But that hardly qualifies as adequate access for the public.
Now, as far as the quality of the payment data in these two
States is concerned, again, many of the entries aggregated the
data, describing payments made to multiple physicians. Others
describe payments made to individuals, so it is very hard to
interpret.
In Minnesota, some of the disclosures were handwritten, and
I can speak for myself in saying that the handwriting of a
doctor is not to be trusted, and, certainly, we encountered
that kind of difficulty in Minnesota. The data quality was also
poor, with many entries providing no information on the payment
purpose.
Now, as to the value of these disclosures, which we think
is a dramatic understatement of the amount of payments that
actually take place due to the various exemptions and because
of the threshold for reporting and underreporting by the
companies--because it is clear that many of them don't report
each time. We focused on those payments that are valued at over
$100, because that is what the AMA and the PhRMA codes say is
the limit that one ought to respect.
In dollar terms, in Vermont, 61 percent of all of the State
payments were withheld on trade secret grounds, which I alluded
to earlier, and of the publicly disclosed ones, which were a
minority, there were 2,416 to physicians for $100 or more,
totaling $1 million over a 2-year period. The median payment
was $177, and the largest payment was $20,000.
Sixty-eight percent of these payments were in the form of
food, which clearly provides no patient benefit and, therefore,
in our view, is likely to violate the AMA and the PhRMA
guidelines.
In Minnesota, over a 3-year period, there were 6,238
payments to physicians for $100 or more, totaling $22.4
million; median, $1,000; highest gift, $922,000. Again, because
of deficiencies in the laws and their enforcement, we think
these are substantial underestimates of the extent of actual
gift giving.
Payment disclosure laws are a first step toward addressing
the overall problem of drug company marketing, but they are not
the only method, and they are not necessarily even the most
effective one. No physician is obligated to accept the gifts.
It does take two to tango, and there is an organization which
has identified at least about 500 physicians who have taken a
pledge not to take any gifts whatsoever from drug companies.
Certain prominent medical schools, as laid out by Dr.
Kassirer, have severed their ties in various respects with the
drug industry. The industry and the AMA have their own
guidelines, but as we pointed out, those are voluntary and
rather weak. We also need stronger enforcement of existing
restrictions on marketing at the levels of the Justice
Department, the Federal Trade Commission, the FDA, and State
Governments.
So let me conclude with my recommendations.
The first overriding point is that any national law should
include device and biologic companies as well.
But, really, my most important point is where I started.
What we really need here is a national law. The overall quality
of the statutes in the different States has been poor. Their
implementation has been worse. Because the physician payment
issue is a national one, not a State one, the most rational
approach to this issue is a national reporting requirement.
Thank you.
[The prepared statement of Dr. Lurie follows:]
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The Chairman. Thank you very much, Dr. Lurie.
Now we will hear from Representative Treat.
STATEMENT OF HON. SHARON TREAT, STATE REPRESENTATIVE, EXECUTIVE
DIRECTOR, NATIONAL LEGISLATIVE ASSOCIATION ON PRESCRIPTION DRUG
PRICES, HALLOWEL, ME
Hon. Treat. Thank you very much, Chairman Kohl. I am very
pleased to be here today to testify on behalf of State
legislators on what is a very important issue.
I am Sharon Treat, a member of the Maine House of
Representatives, as well as executive director of the National
Legislative Association on Prescription Drug Prices, which is a
network of State legislators around the country, stretching
from Alaska to Maine, working on prescription drug issues,
trying to increase access to lower-priced drugs.
Since at least 1993, as you have heard, when Minnesota
passed the first State law banning certain gifts and requiring
the disclosure of drug industry marketing payments, States have
been at the forefront of efforts to ensure that the
pharmaceutical industry does not unduly influence the practice
of medicine and adversely affect patient health and safety.
As of this month, at least 30 States have enacted laws or
introduced legislation on one or more of the following topics:
disclosing spending, as we have just heard; beefing up State
authority to enforce misleading advertising and marketing
rules; protecting privacy by restricting the marketing use of
prescription data; regulating instant messaging and advertising
in electronic prescribing software; regulating drug industry
sales representatives' activities; establishing independent,
evidence-based, detailing programs; and requiring disclosure
and posting of clinical trials information.
The States' actions find their legal and policy support in
the traditional State role of licensing doctors, pharmacists,
and other healthcare professionals; protecting consumers from
misleading advertising and unsafe products; protecting the
public health; ensuring that private information is protected
from unwarranted invasions of privacy; and partnering with the
Federal Government in funding and administering Medicaid and
now Medicare Part D.
Without the data collected through the Minnesota disclosure
law, we would not have had the week-long series of front-page
articles in the New York Times detailing payments to doctors
and the questionable or unsafe prescribing patterns attributed
to some of those doctors.
Without the public online clinical trials databases
required by the Paxil settlement, a case brought by State
attorneys general, spearheaded by New York, the data would not
have been available which formed the basis of a study linking a
popular diabetes drug to increased risk of heart attack. We
have heard about that already this morning.
Maine law requires the results of all clinical trials to be
published online, and other States are following suit. State
attorneys general have been in the forefront, initiating
consumer protection and Medicaid fraud prosecutions for
kickbacks and misleading marketing tactics, including off-label
promotions and failure to accurately and completely disclose
adverse effects. The multi-State Neurontin litigation and
Oxycontin cases are examples.
States are concerned that marketing activities affect
patient safety and provider prescribing patterns. Vermont, West
Virginia, California, the District of Columbia, and Maine have
joined Minnesota in requiring disclosure of marketing and
advertising spending, as you have heard, with some concern
about how effectively they have done it. However, they have
gone ahead to try to get the information.
Maine and Vermont also grant clear authority to enforce
misleading marketing standards in the courts. These States have
acted, in part, in response to a significant reduction in
recent years in the overall number of Federal enforcement
actions for misleading marketing as well as FDA delay in acting
to curb abuses.
Vermont now requires in a recent law enacted just this last
month that pharmaceutical sales representatives disclose to the
prescriber evidence-based information, including alternatives
to the drugs that they are marketing, as well as the cost of
treatment.
Pennsylvania has a comprehensive evidence-based academic
detailing program to provide objective information and
``unadvertisements'' to physicians to counteract biased or at
least one-sided information that is provided by sales
representatives. Several other States have followed suit.
With Medicaid costs always a significant factor in State
budgets, States are looking at issues of doctor and drug
company conflicts of interest, payments for prescribing and for
specialty drugs, and the targeting techniques for marketing,
such as data mining. Data mining also raises issues of privacy
that resonate with State legislators and their constituents
familiar with these issues in other policy areas.
Many States have passed medical records confidentiality
laws that predated HIPAA by many years. Some of these laws were
significantly more protective of patient privacy than the
Federal law that followed.
Over the past decade, States have also dealt with privacy
issues related to credit cards and credit ratings, debating
between opt-in and opt-out approaches that mirror the debate
right now over prescription data. A landmark 2006 New Hampshire
law prohibits the use of doctor specific prescription
information for drug marketing purposes. The data can still be
used for health purposes, such as tracking patient safety. At
least 13 States have similar proposals with two more signed
into law this month, Vermont and Maine.
There certainly is a strong role for the Federal Government
to take action in many of these areas. To begin with, just to
shine a light on marketing practices, as this Committee is
doing, is of great value.
There is also a need to have much stronger standards
governing conflicts of interest, to take action to curb
misleading marketing, and to require disclosure of payments and
gifts, as well as of clinical trials data and other safety
data.
It would also, I need to stress, be a major step forward if
the Federal Government would start by vigorously enforcing the
laws already on the books which bar misleading advertising and
off-label promotion, and if labeling standards and enforcement
were not subject to negotiation with the industry.
That said, we do have concerns about laws which might
preempt State authority to act, particularly in those cases
where States are acting within their traditional regulatory and
enforcement functions and have actually stronger State laws.
States have a traditional and effective role in enforcing
consumer protection and misleading advertising laws, protecting
public health, regulating medical professionals, implementing
Medicaid, and safeguarding the privacy of their citizenry. It
would be a bad bargain to trade strong State laws, even if they
are in place only on a patchwork basis, for weak Federal laws
that limit or prohibit State action.
States are passing laws because there is a regulatory and
enforcement void. But public health issues need to be
addressed, nonetheless, and they are taking action to do that.
Congress should act, but it should partner with the States
rather than preempt them.
I do have a whole lot of information about the specifics of
what every State is doing appended to my testimony, which I can
go over in more detail later on if you are interested.
Thank you very much.
[The prepared statement of Ms. Treat follows:]
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The Chairman. Thank you very much, Representative Treat.
To the entire panel, I would like to devote the time of my
questioning to this issue of a registry that would require
virtually all payments of any sort that are made from the
industry to physicians to be made public and to be made
available to people wherever and whenever they wish.
Do you think that this is something that we should be
doing, that it is necessary, that it would have an impact, a
positive impact, would be a great step to take? Do you see
problems in doing it? Do you think we ought to get after it as
quickly as we can?
What is your opinion, your experienced opinion, on this
question of full disclosure of payments of any sort that are
made between the industry and physicians?
Dr. Kassirer.
Dr. Kassirer. Thank you, Mr. Chairman. I was extremely
impressed with the reporting of Gardner Harris on the
information that he was able to obtain as a consequence of the
State laws.
What surprised me about it was that there were insights
that I hadn't even thought about that came out, including the
notion that there were physicians who had lost their licenses
and were not practicing anymore, who were still allowed to do
research for industry. That information would never have been
otherwise available. These were physicians who were incapable
of doing adequate clinical research.
I would certainly support the notion that a Federal
registry of some kind would be of value in identifying at least
the extent of the involvement of physicians and industry. I
think that more needs to be done besides that, and I made the
point about shining more light on the problem by commissioning
the National Academy of Sciences to study the issue.
I spent time with the president of the Institute of
Medicine about a year ago. He indicated that he would be
interested in doing such a study, but didn't have the funding
to do it. The study that the Institute of Medicine did on
medical errors shined a light on a series of extremely
important issues that were, before that, hidden. I think the
same could be true of a study by the IOM of this particular
issue.
But in terms of a Federal registry of some kind, I am all
for it.
The Chairman. Dr. Rosenthal.
Dr. Rosenthal. Thank you, Mr. Chairman. I agree with [off-
mike]--I am still having microphone problems, but I think it is
OK. I agree that the concepts of light and disclosure are very
useful in this area, and there are a number of areas that need
light shed upon them, and this is one.
The data as to which doctors are receiving which kinds of
valuable consideration, whether they be payments or stock
options or whatever, is available. It exists, and I think that
that data needs to be disclosed. It needs to be completely
transparent, and we should demand it. I think that would be a
great and fairly easy way to generate a database of that
information for public use.
There are several other areas that need illumination, and I
assume we can talk about that later.
The Chairman. Thank you.
Dr. Lurie.
Dr. Lurie. I think my testimony makes clear that I do think
it is a good idea, but let me make three points--well, four.
The first is that there is a tendency to think of
disclosure as a panacea in a lot of areas, not just this one.
So, as welcome as a registry would be, I think we need to think
beyond that, and some of those are laid out in my testimony.
The second point is just to refer to what Representative
Treat had to say. I certainly agree that the last thing we need
is a national registry that is weak and has the effect of
preempting the, at least, good attempts that have been made at
the State level, so preemption should not be of stronger State
laws. Of course, a good cure for that is just to have a good
Federal one.
My next point is when it comes to shining light on this, I
mean, part of what has allowed all of this to take place to
date is, in fact, that it occurs, in effect, in darkness. I
think it is worth thinking about the 2002 American College of
Physicians' policy statement regarding pharmaceutical
companies.
They offer three criteria for determining the
appropriateness of a payment, and the first one is, ``What
would my patients think about this arrangement? What would the
public think? What would I feel if the relationship was
disclosed through the media?''
What these disclosure laws do, in effect, is to put these
theoretical questions that the ACP says are so important to the
test and allows patients to make up their minds for themselves.
My final point is this. When we set about writing our JAMA
paper--and my co-authors who are here will attest to this--I
was somebody who was rather skeptical about the naming of
physicians. I thought that what we wanted to do was provide
aggregate information and be able to describe the extent of
things in a kind of public health way, not in an individual
way.
But in the course of doing the study, a lot of private
information--not private, but personal information did come
out. I have become a strong convert to the idea that, in fact,
there is a lot to be gained from putting out the actual names
of the doctors. There is a lot of creative work, some of it
done in the New York Times, in which you can link particular
people to other information, be it doctor disciplinary records,
whether or not they are key opinion leaders, et cetera, et
cetera, whether they sit on FDA advisory committees.
All of those kinds of things can only be done when you have
the doctors' names. If the doctors are not ashamed of this,
they shouldn't be objecting to this.
The Chairman. All right. Thank you so much.
Representative Treat.
Hon. Treat. Yes, thank you. I would concur that if we can
do it right, a national registry would be great.
I was interested in Dr. Lurie's testimony, because those
are a lot of the issues that we, as an organization, are
advising States, about what is the best way to write these
State laws when they go about it.
We are trying to make sure that they don't look at a law
that has been passed somewhere else and say, ``Well, that
passed. This is the way to go,'' because many of those, of
course, include compromises that went into effect and were the
only reason the law passed. Those compromises really are the
loopholes that Dr. Lurie has identified.
Certainly, having prescriber identity is important. I know
that that is something that the Vermont legislature has been
trying to focus on and make sure that its laws, which initially
had that only in the aggregate, now provide in more
specificity.
I think we need to remember that some of the State laws
were initially passed without really understanding the
relationships between these payments and actual prescriber
behavior. A lot of the States were actually looking initially
to shine a light on how much money was being spent on marketing
and advertising activities.
So many of the laws are really focused on just collecting
information on how much money was spent as opposed to really
making the link between prescriber behavior and payments to
those prescribers. I think States have become more and more
aware of that, particularly as the data in Minnesota is now
being analyzed, and I give a lot of credit to the New York
Times and the reporters there for actually spending, as I
understand, well over a year going through those boxes.
Just in Minnesota's defense, I think that the Web and Web-
based information was a lot less common in 1993 than it is in
2007. That brings me to my point that having Web access, and
having it in a format that is, in fact, accessible would be
very important.
I agree with Dr. Lurie that the trade secret exemption is
an exemption that can be a loophole that swallows the whole
rule. This comes up in many, many contexts. It is very
important to get that right and to make sure that just anything
can't be claimed to be a trade secret and thus be protected
from disclosure.
I agree on the medical devices, making sure that those are
in. I think, again, that is something that when State
legislators were passing these laws, they were focused on
prescription drugs and not so much on medical devices. But that
is an issue that has come to light.
Another area where there are loopholes in the Minnesota and
other laws is the definition of educational activities and
continuing medical education activities and making sure that
those are included as well.
I just say that transparency alone may not be enough, and I
think many States think that it isn't enough. Certainly, an
analysis of the data from Minnesota shows that the voluntary
guidelines that are in place are not being honored. So it may
be that since no one knew what was in those documents, since
they were all in big boxes, it is not a fair test of
transparency, and a registry that had information posted on the
Web somewhere where everyone could go see might be much more
effective.
But that said, there are a lot of other issues. Some of
them have been alluded to by other members of the panel, and
some of them are addressed in the State legislation that I
mentioned, including the kinds of practices that go on in
doctors' offices, the data mining issues, and some of the other
things around actually banning gifts that might be appropriate
for this Committee and Congress itself to consider doing.
The Chairman. Dr. Kassirer.
Dr. Kassirer. Thank you, Mr. Chairman. Dr. Lurie's comments
reminded me of a point that we really must make, and that is
that we have spent a lot of time talking about disclosure. In
fact, if you look at the reports in the newspapers, it has been
largely about the lack of disclosure.
So people have made a lot about the fact that physicians
have done various things and made various comments but have not
disclosed their ties with industry, which could have influenced
their opinions.
The fact is that we must pay attention to a much more
fundamental issue, and that is that disclosure is perhaps
necessary in terms of identifying those who have conflicts of
interest, but it is not sufficient, because disclosure doesn't
solve the problem. The problem is the conflict, and disclosure
doesn't solve the conflict.
The Chairman. Very important point.
Well, we have with us today a distinguished senator from
the State of Delaware, Mr. Tom Carper.
We would love to hear your comments and questions, Senator
Carper.
Senator Carper. Thank you, Mr. Chairman.
I am happy to be here, and I think this is a busy time--we
have three separate hearings going on at once. We are being
briefed by the director of national intelligence, we are doing
immigration reform on the floor, and we have got a bunch of
people here from Delaware. But I wanted to be here at least for
part of this, because this is a good and important hearing.
I have missed your statements, and what I am going to ask
you to do--and I do this sometimes when I am sort of in and out
of a hearing. But could each of you take maybe a minute or so
and give me a couple of major takeaways, from your opening
statements please.
Representative Treat, that is a great name. That would be a
great name to have as a politician. If I had a name like that,
I could go somewhere. [Laughter.]
Hon. Treat. Especially when you are going door to door
right before the election, which would be around Halloween.
Senator Carper. You probably have a lot of fun with that.
Hon. Treat. Yes. Well, thank you very much for an
opportunity to reiterate everything I said already, which I
won't do. [Laughter.]
Senator Carper. Not everything, not everything.
Hon. Treat. No, I won't do that. But my takeaway would be
that, you know, States have really been in the forefront on
this issue, not only on disclosure, but in a lot of other
areas.
Let me just give you an example. I think as sort of an
early warning system, one of the bills--actually, it is a bill
I sponsored, and it was initially passed into law in Florida,
and Vermont just did it, and it looks like New Hampshire is
just about to. It focuses on a whole new area of electronic
prescribing, where there is this huge push, a lot of it going
on here in Congress, to get doctors to put everything onto
electronic recordkeeping, you know. Well, what that means--and
actually have electronic prescribing, where you just write into
your PDA and it goes straight to the pharmacist.
That enables tremendous new tools in terms of mining that
data, questions about privacy. Questions in this legislation--
the legislation I had and others had, which are actual messages
that pop up from a pharmaceutical company. Let's see. You are
just about to write a prescription for a particular drug, and
it says, ``Hold on there. I will show you one that is
prescribed as--Drug Y has much better effects,'' and all this
clinical information, and that could be a lot better.
Well, you could see that being done in a way that is very
objective and presenting information on all sides. But you
could also see it--as has been the experience in Australia,
which is much farther along this road of electronic, you know,
records and prescribing--as really interfering with doctors'
behaviors and actions. This is an issue that the States are
focused on, and the Federal Government is very far behind.
So, I guess, you know, my message is that States may not be
doing it perfectly, but they are kind of an early warning
system, and they are tackling issues that aren't likely to be
addressed anytime soon by the Federal Government. We need to
make sure that as Congress moves ahead in doing things like a
registry, which I think is a great idea, that we are not
preempting State laws that might actually be stronger.
Maine has a clinical trials database law that is far more
comprehensive than the Federal law on the books. If there were
preemption of State laws, you would end up not actually getting
the data from Maine. So that would just be my proviso on it,
and there are a lot more issues than just transparency for you
to focus on.
Senator Carper. Thank you, Representative Treat.
Dr. Lurie.
Dr. Lurie. As long as you are making observations on
Representative Treat's name, I will point out that she is the
right person to be speaking at a meeting about conflict of
interest. It really seems just the right name for that.
The points that I made in my testimony were, one, that
physicians typically believe they are unaffected by
interactions from drug companies though they believe that their
colleagues are likely to be affected, which is, you know, kind
of a logical contradiction.
Senator Carper. What we hear around here sometimes, you
know, we work on ethics legislation, you know.
Dr. Lurie. Right. It is, ``I am immune, but nobody else
is.'' I went on to talk about some of the successes of the
State payment disclosure laws. Then I went on to talk about the
five that have so far been enacted, and I pointed out that
there were a number of gaping holes in those, and I pointed out
that sometimes the exemptions swallow up the law itself.
But there are ways to make them better, to be sure, and we
lay out a series of recommendations at the end of our
testimony, which run the gamut from literally how to enter
things on the Internet to what the exemptions should be and so
forth--how often reporting should be made to the legislature
and so on.
Anyway, the point is that there are holes in all of the
existing State pieces of legislation so far. Then we went on to
look in more detail at Minnesota and Vermont, which are the two
that actually have reporting requirements that are in place.
We showed that the accessibility of payment data is very
poor, that either through the legal loopholes or through,
really, negligence on the part of the Board of Pharmacy in just
not analyzing the data that kept coming in, there is de facto
little access to information, that the quality of the payment
data in data terms is often poor, allowing aggregation of data
where individual data would be much more helpful, both for the
public and for researchers, that----
Senator Carper. Doctor, I am going to ask you to go ahead
and sum it up, because I need to hear----
Dr. Lurie. Absolutely.
Senator Carper [continuing]. From the other witnesses,
and----
Dr. Lurie. That is fine.
Senator Carper [continuing]. Senator Kohl has infinite--
well, almost infinite patience, but he won't let me go on
forever, so just wrap it up, please.
Dr. Lurie. I am sorry.
So the disclosed payments are large in our study in the
JAMA, although they are probably underestimates. Finally, as a
result of this, we conclude that a national State reporting law
is what is required, although we agree with the comments of
Representative Treat about preemption.
Senator Carper. Good. Thank you. Thanks so much.
Dr. Rosenthal, just a minute or 2 of a takeaway, please.
Dr. Rosenthal. Thank you, Senator.
I would encourage you to read the written statements and,
also, some of the media coverage of this is covered on our Web
site, the Physicians for Clinical Responsibility Web site,
which is clinicalresponsibility.org.
In a nutshell, my testimony was the view from the trenches,
particularly in retinal surgery. It is a before-and-after
story.
Until seven years ago, research was independently funded.
It was credible. It was trustable. People would get up at
meetings and give talks that you knew were fact based and
unbiased.
About seven years ago, with the advent of a treatment
called photodynamic therapy, this brought in the era of
corporate sponsored clinical trials. Since then, it has been
one example after another, and with each succeeding iteration,
the drug companies have gotten better at marketing to doctors,
crossing the line to paying poorly qualified clinical doctors
to do paint-by-numbers research according to their dictates,
and we are supposed to just trust their altruism that it is all
unbiased. Studies don't support that unbiased character.
We have seen the sort of perfection of the recruitment of
doctors to be key opinion leaders and to either fail to
disclose or, more commonly, euphemistically disclose their
relationship with companies to the point where we have very
little credibility at society meetings, in many of the--not
all, but many of the journal articles and this sort of thing.
This has created a significant pressure on doctors to
follow drug company party lines on clinical decisionmaking. The
monetary impact of this is phenomenal. There is a single drug--
--
Senator Carper. I am going to ask you, if you will, to wrap
up because my time is limited. Thank you.
Dr. Rosenthal. This is my last thing.
There is a single drug that we are currently expected to
use, that if all patients were treated with this drug,
according to the study protocol, out of Part B, it would cost
about $5 billion per year. That is just a little bit more than
the entire eye care CMS budget.
So, as you can see, the stakes are very high.
Senator Carper. Yes, thank you.
Dr. is it Kassirer?
Dr. Kassirer. Yes.
Senator Carper. Has your name been mispronounced?
Dr. Kassirer. No, it is pronounced correctly. Thank you. It
is usually not.
A couple of words. I have asserted that the medical
profession has become excessively dependent on the largest of
industry, that these financial connections have had a negative
influence on the quality and the cost of patient care and the
trust of the public, and that the profession's response to
these threats have been inadequate. I made the point that the
leaders of the profession have done little to counter a trend.
It always amazes me that there is a paradox in their
policies. On the one hand, they admit that physicians can be
influenced by gifts and trips and things like that, and yet
they allow it, anyway, and that seems to me to be something
that is counter productive in terms of the cost of care and the
quality of care.
Thank you, sir.
Senator Carper. Thanks very much for both of those points.
Mr. Chairman, I have a couple of questions I want to submit
for the record to this panel, if I may.
But thank you for your testimony and for summarizing for
me. Much obliged.
The Chairman. Thank you, Senator Carper. We thank you very
much for your questions.
Senator McCaskill.
Senator McCaskill. Thank you very much.
I apologize for not being here to hear all of your
testimony, although I heard it. You know, it is so funny,
because we have senators give speeches on the floor, and
afterwards, someone says, ``Well, I heard your debate.'' You
realize that most people watching things around here are
watching on television while they are trying to multitask. So,
I was listening to your testimony as I was multitasking
upstairs in my office.
I wanted to focus a little bit on this panel--and anyone
can address this question that would like. I am concerned about
the research component of this.
I am very concerned about the conflicts--if I look through
JAMA and I look through the New England Journal, first of all,
I am concerned about all the ads, and then I am concerned that
we are going to get to the point that the conflict paragraph at
the end of these articles is longer than the article.
Now, the good news is that there is disclosure, and that
these doctors are disclosing that they are receiving money from
these various pharmaceutical companies and these various
prescription drug companies, and that is good. But what I am
worried about is the research that is going on that is not
getting published because maybe the results aren't what the
people who paid for the research wanted.
I am particularly worried about PhRMA research that is
ongoing and that maybe, because the results of that PhRMA
research are not what they hoped it would be, it never sees the
light of day. I would welcome your comments on that potential
problem that we have under the current scenario.
Dr. Kassirer. Well, as a former medical editor, I feel
somewhat compelled to speak out. You are absolutely right about
the disclosures at the end of these articles. They are
monumental, it seems to me.
When I was the editor of the New England Journal, we had a
simple policy, and that is that if someone had a financial
conflict of interest, we would not allow them to write an
editorial or a review article. We also had a policy in which
none of our editors had a financial conflict of interest. I got
a report every single year from all of the editors, and anyone
who developed a financial arrangement was no longer an editor.
With respect to scientific studies, the kinds of studies
you were referring to, first of all, it is possible that one
could eliminate those studies in which people had a conflict of
interest. The problem would be that you would have no studies
left, because most of the studies that are published in major
journals are supported in some part by industry, and many of
the investigators have financial arrangements with industry.
That is the reason for all these disclosures that you have now
begun to see in medical journals.
What I am always surprised about is how many of these
investigators have how many conflicts of interest--some of
them, 15 or 20 or 30 conflicts of interest with companies that
they work with. You have to ask yourself, ``What are they doing
at home if they have conflicts of interest with all these
different companies?'' Whether or not these conflicts influence
the science is a critical question. I can tell you that two
British editors, Richard Smith, the former editor of the
British Medical Journal, and the editor of the Lancet, Richard
Horton, have recently spoken up, saying that they don't trust
the studies that even they themselves have published in their
journals.
With respect to the advertising in the journals, well, it
is a complex problem. I can tell you that the New England
Journal--when I was there, the New England Journal could have
survived financially with just the job ads and the subscription
cost of the journal, and you could have eliminated all
pharmaceutical ads.
But the Massachusetts Medical Society that owned the
journal would never have heard of that. I mean, they made a lot
of profit on the journal, and they built an incredible
organization as a consequence of all those profits.
I can tell you one thing about--at least, I can tell you
about the New England Journal, and I am sure it is certainly
true today--and that is that the ads in the journal have never
had any kind of effect on the content of the journal, the
editorial content of the journal. I am sure that is also true
for JAMA. I can't tell you for sure if it is true for all
medical journals.
It certainly is possible that, in some way, medical journal
editors are influenced by their advertising. In fact, you heard
already--Greg mentioned an example where a medical journal
editor refused to publish one of his conflict of interest
pieces because he was afraid an advertiser would go away. So I
think there may be examples in which editors craft their
content, their editorial content, based on their advertising.
With respect to negative studies, it is a mixed bag, I
think, in the sense that journal editors are not excited about
publishing negative studies, anyway. They are not very exciting
studies. So some of the reason for these studies not getting
published might be the fact that journal editors just turn them
away. They are not interesting.
On the other hand, the current crop of medical journal
editors have set out a series of guidelines requiring the
registration of clinical trials, and that registration would at
least alert you to the fact that there is a study that hasn't
been published. It is not complete. It needs a big fix before
it can function effectively.
So is it possible that there are studies with negative
results that are not being published? Yes, it still is
possible.
Senator McCaskill. Well, I think figuring out a way that
everyone knows when clinical trials are going on would be
really, really important, because then there would be an
opportunity for research--even if they were not published.
Now, with our technological capability in terms of the
Internet, there is absolutely no reason that non-published
stories could not be available to people who are interested,
and that information that clinical trials are ongoing, I think,
would be key.
Just briefly, one follow-up question, Mr. Chairman, if you
don't mind.
If, in fact, the large hand of the pharmaceutical industry
is essential to these research projects going forward, then
would it be the opinion of the panel that independent research
at--and here is what I am referring to now.
At higher education institutions, where these companies are
coming in and saying, ``We will give you money at your school
if your academicians in the medical field will do these
studies,'' and then you have academicians now kind of being
harnessed by virtue of the flow of money--and what worries me
is where are we going to end up 10 or 20 years from now in
terms of truly independent academic studies.
Are these academicians that may want to go and research
something that would be a terrible outcome for the flow of
money--and I think this may be, frankly, a corollary of the
fact that we have sadly, sadly, in this country, short-changed
higher education in terms of research money and the kind of
money that we need to be investing in terms of keeping the
prominence of our country in terms of the field of higher
education.
Now, that is my own political bias about funding higher
education. But if any of you would comment on that? Yes?
Dr. Lurie. Well, I certainly agree with all of this.
I think when we talk about the conflict-of-interest
statements, first of all, I mean, I think they have become so
long that we literally risk turning them into a laugh line at
some point, where it becomes a joke the way the surgeon
general's warning on tobacco became a joke after a while, and
you wind up on ``Saturday Night Live'' joking about the extent
of the disclosures. I once read the transcript of an FDA
advisory committee meeting, where they are busy disclosing all
of this, and somebody gets up to say, ``I just want to say you
didn't mention my conflicts. I don't have any, but I sure wish
I did,'' you know.
So it becomes a bit of a joke, and that is one of the
limitations of disclosure, as important as it is.
I think when it comes to the research, as important as all
of the data suppression examples--which there are, be they the
class study with regard to Celebrex, where the company
published half the data, because it knew that the full data set
that it had in its possession didn't show the benefit that half
the data set showed; or be it withholding of the studies on
SSRIs, many of which turned out to be negative, as far as the
company was concerned.
By the way, the FDA knew all of this, and because of its
own secrecy laws wasn't able to expose the way that the
companies were withholding the information. So the levels of
secrecy at the FDA are also a part of the problem here.
But with regard to the funding of research, as important as
the data withholding is, probably more important is the fact
that as industry is a larger and larger funder of research in
this country, they are setting the agenda. They are asking the
questions. They decide which questions get asked and which
ones, in effect, do not, because the academicians have only so
much time to do their work.
You know, physicians could say no to that--the researchers
could say no to that money, but they don't. So what we have are
questions that are of interest to drug companies that may be of
absolutely trivial interest to the public health: whether the
24th non-steroidal anti-inflammatory drug has some minor
advantage over the 25th non-steroidal anti-inflammatory drug. I
am just not that interested in that question.
I am interested in questions about diet and exercise and
truly breakthrough drugs. But those studies are harder to get
funded, and the industry is not nearly as interested in them.
I will point out that back in the 1970's, there were
proposals that the pharmaceutical industry would pay into a
large pot from which studies would be done, selected in terms
of their public health importance by impartial people and then
conducted by people who would be responsible for both doing
them and analyzing them. That is really the way out of this
problem. I mean, it is----
Senator McCaskill. What happened to that suggestion in the
1970's?
Dr. Lurie. You know, it went the way of many proposals, I
am afraid. We hear about it periodically as if it is, you know,
something completely impossible. Actually, the New Yorker has a
little article about it just this week in which that idea is
revived as if it were something new. But it is something that
periodically percolates up as----
Senator McCaskill. I think that would be a spectacular
idea.
Dr. Lurie. I would agree.
Senator McCaskill. It would solve the problem.
Dr. Lurie. Yes, it would. Unfortunately, certain of the
monied interest wouldn't be terribly happy with it, and that is
probably where it went. But I agree with you.
If you think about it, as Dr. Kassirer was saying, when you
think of conflict, I mean, the best solutions to conflicts are
not merely disclosure. They are structural approaches that
remove conflict, and this would be an example of the same.
Senator McCaskill. Right.
Mr. Rosenthal.
Dr. Rosenthal. If I could quickly comment on a couple of
things, first, I would like to point out that, in my field of
retinal medicine, there are many very, very good researchers
who are trying to do good work and trying to do non-conflicted
work. I believe that they find it annoying that there is so
much pharmaceutical influence, because it does make it hard for
the reader to know what is biased and what isn't, and I think
that casts good work in a more tentative light as well.
I also wanted to agree that there are many areas where it
is the way you ask a question, it is what you decide to look
at, that sort of thing. There is one study of a commonly used
treatment where they redefined visual success to include three
lines of visual failure. If they hadn't done that, the data
wouldn't have looked so good.
Senator McCaskill. Right.
Dr. Rosenthal. That same study elected not to look at
toxicity effects for 3 months after the treatment. We now know
that that particular treatment is highly toxic to the macula.
There is another example where a company had two versions
of the same drug. One had already been priced for another
treatment and could be available in doses we needed for eye
care at around $50 a dose. The other version of the same
molecule is $2,000 a dose, and you have to give it more often.
So which would you choose to study in a randomized trial and
get approved? It is not hard to see.
Senator McCaskill. Thank you, Mr. Chairman, very much.
The Chairman. Thank you, Senator McCaskill.
We thank this panel exceedingly for being here today. You
have provided great testimony, great observations, and,
hopefully, we will be able to make some progress as a result of
your testimony. Thank you for being here.
Our second panel consists of two witnesses.
The first will be Dr. Robert Sade. Dr. Sade is chair of the
American Medical Association's Council on Ethical and Judicial
Affairs, and he is a professor of cardiovascular and thoracic
surgery at the Medical University of South Carolina.
Our second witness will be Marjorie Powell. Ms. Powell is
the senior assistant general counsel at the Pharmaceutical
Research and Manufacturers of America. Her current work focuses
on the legal implications of State legislation regarding
prescription drugs as well as oversight of PhRMA's legal
matters.
We thank you both for being here.
Dr. Sade, we will take your testimony.
STATEMENT OF ROBERT SADE, CHAIR, COUNCIL ON ETHICAL AND
JUDICIAL AFFAIRS, AMERICAN MEDICAL ASSOCIATION, WASHINGTON, DC
Mr. Sade. Thank you, Chairman Kohl and members of the
Committee, for convening this hearing to examine financial
relationships between physicians and the pharmaceutical
industry.
The topic is very timely, and the AMA sees today's hearing
as an opportunity to communicate the ethical standards that
guide all physicians in the practice of medicine and in their
interactions with the pharmaceutical industry.
My name is Robert Sade. I am chairman of the Council on
Ethical and Judicial Affairs of the AMA, and I am also
professor of surgery and director of the Institute of Human
Values and Healthcare and the Medical University of South
Carolina in Charleston.
Physician prescribing decisions depend heavily on a quality
of available scientific information. The pharmaceutical
industry and Federal regulators are important information
sources. There is a clear need for interactions between
physicians and the pharmaceutical industry to ensure the free
flow of valid scientific information.
When the information is accurate and complete, physicians
have the necessary tools to make the right prescribing
decisions for their patients. If information is not properly
provided by industry, or if physicians never receive such
information, quality medical care can be jeopardized.
The AMA was created in 1847 for the specific purpose of
establishing ethical standards for all physicians. The AMA code
of ethics has been continually revised for 160 years, guided by
the Council on Ethical and Judicial Affairs, and serves as the
primary compendium of medical professional ethical statements
in the United States.
The code has clear ethical guidelines that govern physician
interaction with the pharmaceutical industry. For example,
physicians must not place their own financial interests above
the welfare of their patients.
A physician's medical recommendations must not be
inappropriately influenced by financial considerations.
Accordingly, it is unethical for a physician to accept any kind
of compensation from a pharmaceutical company as a quid pro quo
for prescribing its products.
The AMA code acknowledges that the giving of gifts reflects
a customary social practice. However, it warns that gifts to
physicians from commercial businesses may not be consistent
with the AMA code. The code requires that gifts accepted by
physicians must mainly benefit patients and should be of only
modest value.
Also, the AMA code explicitly provides that no gifts should
be accepted if conditions are attached, such as prescribing
certain drugs. All gifts, however, are not inappropriate.
Indeed, many of them will benefit patients. An example is when
physicians provide drug samples to patients who have a
medically indicated need for treatment but cannot afford to buy
the necessary drugs.
The AMA works with State medical associations and specialty
societies to disseminate ethical standards. To ensure
compliance with these standards, the AMA relies not only on the
Council on Ethical and Judicial Affairs, but also on medical
licensing boards.
About six years ago, the AMA undertook a major campaign to
educate physicians and industry representatives about the AMA's
ethical guidelines regarding promotional gifts to physicians
from industry. More than 30 other physician and healthcare
organizations came together to form the working group on the
communication of ethical guidelines for gifts to physicians
from industry. As a result of this collaboration, the AMA
created an awareness program to educate physicians and other
stakeholders on ethical guidelines and developed an educational
program.
The AMA is currently developing a series of educational
programs for medical students and physicians designed to
promote the importance of sound prescribing, focusing on how to
minimize and eliminate undue influence by industry marketing
practices. Special attention is given to medical students in
resident positions in addressing this important issue, since
interactions with industry often start very early in a
physician's professional career.
The interactions between industry and the medical
profession must be defined by the exchange of sound scientific
information which benefits patients. All practices that
surround those encounters, from the visits of pharmaceutical
representatives to large educational gatherings, must be framed
in terms of such an exchange and must not constitute an attempt
to inappropriately influence the medical treatment that
physicians provide to patients. The health and welfare of
patients depend on this.
The AMA looks forward to working with the Committee to
achieve our shared goals. Thank you for the opportunity to be
here today.
[The prepared statement of Mr. Sade follows:]
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The Chairman. Thank you, Dr. Sade.
Ms. Powell, we would like to hear from you.
STATEMENT OF MARJORIE POWELL, ESQ., SENIOR ASSISTANT GENERAL
COUNSEL, PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA,
WASHINGTON, DC
Ms. Powell. Thank you, Mr. Chairman, Senator McCaskill. My
name is Marjorie Powell. I am the senior assistant general
counsel at PhRMA, which is the trade association representing
those companies that are researching and developing new
medicines.
One of the important responsibilities of a pharmaceutical
company when FDA has approved a new medicine is to make sure
that physicians know that the medicine is available and know
how and when to use that medicine and how and when not to use
that medicine. That is the purpose of what is called
pharmaceutical marketing or promotion. It is to make sure that
physicians know when to use and when not to use medicines.
In 2002, PhRMA adopted a significantly revised marketing
code, which focused exactly on that, identifying that the role
of a physician's prescribing is to meet the patient's medical
needs using the physician's medical knowledge and clinical
experience. But some of that medical knowledge comes from using
prescription drugs once they have been on the market and
experience with those drugs. It also comes from learning about
new medicines, and that is the role of the pharmaceutical
industry which has developed those new medicines.
In our code, we have clearly identified that if a
pharmaceutical sales representative is providing a gift to a
physician, it should be to benefit the patient. It should be of
insubstantial value, not of any substantial value. It should
not be frequent. It should also not be in exchange for
prescribing any particular drug.
We also talked about a number of other things in our code,
including the ways that pharmaceutical companies might enter
into consulting arrangements with physicians and other members
of the healthcare profession, because those healthcare
professionals have important information to convey to
pharmaceutical companies, partly running clinical trials, but
also helping a company to identify, for example, why it is that
a patient may not be compliant with a drug regimen and what
kinds of possible changes in a medicine would improve
compliance.
Our pharmaceutical code has been a leader in the industry,
although I must admit that we have clearly followed the AMA in
many of our issues and worked closely with the AMA in trying to
make sure that physicians are aware of the provisions of the
code.
A number of other groups also regulate pharmaceutical
promotion and marketing. The FDA clearly has a major role in
that, as you know, particularly, because you have just
considered the new prescription drug user fee bill that has
moved through the Senate and now moved through the House Energy
and Commerce Committee. In addition, the Inspector General of
HHS has said that compliance with the PhRMA code, while it is
not a guarantee that you will be compliant with Federal law,
goes a long way to indicating that a company is making a major
effort to comply with all the Federal regulations.
Let me turn now to the other side of my testimony, which is
the importance of pharmaceutical marketing. Physicians
recognize that they get valuable information from
pharmaceutical representatives. They also recognize that some
of that information is promotional and that they need to ask a
variety of questions. Physicians are, in fact, trained
professionals who know how to ask questions and how to evaluate
both their own experience and all of the information that they
receive.
Pharmaceutical marketing is an important counter to many of
the other influences on physicians' choices of treatment. For
example, one study found that physicians don't even talk to
patients about treatments that their healthcare insurers will
not pay for. That is a way of screening physician actions that
has nothing to do with pharmaceutical marketing, and, in fact,
one study found that 54 percent of physicians said that
formularies had a major impact on their prescribing.
Another thing that formularies and managed care have done
is to increase the percentage of scripts that are actually
generic prescriptions. In the United States, this past year, 63
percent of all scripts written were for generics. That is a
much higher percentage than in other countries, particularly
Europe, where there is much less pharmaceutical promotion.
Let me wind up by saying--and if Senator Carper were still
here, I would give him my summary by saying--that there are a
number of chronic conditions that are the drivers of healthcare
expenditures. A number of people have identified that
approximately 75 percent of healthcare spending is on chronic
diseases, many of which are undiagnosed or underdiagnosed and
clearly are undertreated.
Prescription medicines are prescription medicines, not
over-the-counter medicines, because they have both benefits and
risks, and they can only be used, in the opinion of the FDA,
when they are prescribed by somebody with medical education and
professional clinical experience. That is why it is important
that the companies who have developed those medicines
communicate information about both the benefits and the risks
of those products to the people who will be prescribing them.
[The prepared statement of Ms. Powell follows:]
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The Chairman. Thank you very much, Ms. Powell.
Dr. Sade, the guidelines that the AMA has out there, would
you support making these guidelines mandatory, and would you
support enforcing your guidelines?
Mr. Sade. Thank you, Senator Kohl.
The guidelines of the American Medical Association already
are being enforced. The Council on Ethical and Judicial
Affairs, of course, has jurisdiction only over its own members.
But the council screens between 250 and 300 alleged
physician violations of the ethical code every year, and of
those, 30 to 40 actually come to a due process hearing.
Sanctions are levied against some members of the AMA in the
form of having their membership revoked or having their
membership suspended or being put on probation, et cetera.
But the reach of the disciplinary value of the AMA code
goes far beyond that. Most medical boards in the United States
use the AMA's code of medical ethics as their standard for
ethical behavior of physicians, and they sanction physicians
based on violations of the AMA code. That is a very powerful
influence of the code on medical practitioners.
The courts also refer to the code in deciding, actually,
many cases, and that is another way in which the code is very
useful in the American judicial system. So I don't think it is
quite accurate to say that the code of ethics of the American
Medical Association isn't being enforced. In fact, it is.
The Chairman. So you would support full disclosure in a
national registry?
Mr. Sade. I don't know the answer to that question, because
the AMA has not yet considered it or deliberated over it.
The Chairman. Well, do you consider it to be a good idea?
Mr. Sade. I don't know that, because we only have a limited
experience with the States, which I think are very valuable
experiments in determining the benefits of such a program, as
well as the potential risks of such a program. Both the
benefits and the risks were pointed out by the previous panel.
The Chairman. How do you feel about Minnesota's law?
Mr. Sade. Well, I will say the same thing, that the
analysis of the data is too incomplete at this time to make a
decision. But the fact of the matter is that AMA has not
developed any policy on this, but it is monitoring the
situation closely and will be creating policy in the near
future.
The Chairman. Ms. Powell, how do you feel about full
disclosure in a national registry?
Ms. Powell. We have been working with a number of States as
they have first considered legislation and then developed
regulations. It is very clear that the State legislators, as
they have been putting together legislation and making
amendments, have not fully understood the complexities of what
it was that they were dealing with or the potential interaction
with FDA regulations, which, of course, are national and are
the ones that pharmaceutical companies have to abide by.
As they have moved to the regulation stage, they have had
even more difficulty in defining what it is they think should
be included in a registry. So we would caution that that
indicates that perhaps there is a need for much consideration
about what would be included. Take, for example, the question
of pharmaceutical samples, which some States have defined as
gifts, but which we think are essential practice tools for
physicians and patients to learn about whether a new medicine
will be helpful for them, particularly when a patient may not
have insurance.
There has been one study that found that a large number of
the patients to whom physicians have given samples were
patients without insurance. If you define those as gifts, that
implies that the physician is receiving a benefit, when, in
fact, the samples are, under FDA law, required to be given free
of charge to patients who need them. So there are those kinds
of complexities that would make the effort toward developing a
national registry very difficult.
The Chairman. OK.
Senator McCaskill.
Senator McCaskill. I know, Mr. Chairman, they have called a
roll-call vote, and so we don't have much time.
You know, we are trying to go through the process of
lobbying reform in Congress right now, and I think anyone would
have to be honest and acknowledge that a lot of what is going
on with the pharmaceutical industry, as it relates to their
contact with doctors, is lobbying. It is lobbying, pure and
simple.
My brother ran a restaurant in Springfield, and he said the
most lucrative part of their business was the private room that
was reserved by pharmaceutical companies four nights a week.
The wine consumed was unbelievably expensive. The dinners were
unbelievably expensive. Now, I have got to tell you, I don't
think most Americans think that is about patients first. That
is about lobbying.
What I would ask of PhRMA is if we are going to limit the
lunches that can be bought for Members of Congress in the
context of lobbying, shouldn't we have the same kind of
disclosures with doctors, because there is a financial
relationship there. If, in fact, it is about the patient, then
PhRMA should have no problem with disclosing how much money
they are spending on doctors in terms of recreational time.
I am not talking about a member of the pharmaceutical
industry visiting an office and dropping off some sample packs.
I am talking about golf. I am talking about trips. I am talking
about dinners. I am talking about expensive wine. Why in the
world would we allow that to go on without the public and the
patients knowing that is going on?
Ms. Powell. Senator McCaskill, under the PhRMA code, as it
was issued in 2002, expensive dinners, wine, golfing trips,
sporting events are inconsistent with the PhRMA code. They are
inconsistent with the inspector general's description of the
guidance for the pharmaceutical industry. They are inconsistent
with the requirements of various individual company compliance
and ethics codes.
I would, with all due respect, suspect that there has been
some change in your brother's experience in the restaurant in
recent years, because I know that there have been changes in
the kinds of behaviors. Pharmaceutical representatives, when
they are buying meals for physicians, are buying them in a
place where it is quiet, and they can focus on communication of
information. I don't believe that there are lots of examples of
the type you describe, and if there are, I would certainly
encourage you to forward them to the companies involved,
because I think those are now inconsistent with both the AMA
and the PhRMA code.
Senator McCaskill. So they are not allowed to buy alcohol
for doctors anymore?
Ms. Powell. The code says that they may buy a meal in a
reasonable setting at a reasonable price----
Senator McCaskill. That wasn't my question.
Ms. Powell [continuing]. Which I would----
Senator McCaskill. Are they allowed to buy alcohol for
doctors anymore, yes or no?
Ms. Powell. Our code does not explicitly go to that level
of detail----
Senator McCaskill. So they can?
Ms. Powell. If a company were to decide that a glass of
wine was reasonable, yes, I think they could. But the purpose
of the interaction would be communicating information to the
physician, and that would more likely happen in a setting where
you didn't have either food or alcohol, or perhaps you were
bringing pizza so that not only the physician, but the nurse
practitioner, who is actually dealing with the patient and
telling the patient how to use the medicine, knows what
information needs to be conveyed to the patient.
Senator McCaskill. I just don't have a sense that the
enforcement--I mean, I know, Dr. Sade, that the AMA has done
some in this area. But there is, I think, out there a real
perception, and--as we do here in this body. We fight
perception sometimes, not reality.
I don't think that lobbyists buying lunch for any
individual congressman is necessarily polluting the process.
But what has happened is because of abuses over the years and
because of the prevalence of that kind of activity, we are now
moving to cutoff that kind of activity and, therefore, doing
something about the perception.
I just think that your industry has got your head in the
sand if you think you have turned the corner on this, because I
don't believe, in terms of the public's perception, that you
have at all.
Mr. Sade. If I may comment----
Senator McCaskill. I am sorry. We have a vote, and----
The Chairman. I will give you 30 seconds, so go ahead, Dr.
Sade.
Mr. Sade. OK, a 30-second comment.
Over the last 4 years, since the PhRMA code went into
effect, we in my medical school have noticed a distinct change
in the relationship of pharmaceutical representatives and
physicians. Expensive dinners never have taken place all that
much. Yes, they do take people to dinner, but they are always
at modest prices and at restaurants in which actual real
educational programs take place.
So I think that the perception lags the reality in this
case. The perception will change when the reality becomes more
obvious.
Senator McCaskill. Thank you.
Ms. Powell. Senator McCaskill, we are working to educate
not only our company sales representatives and, with the AMA
physicians, but trying to change the perception. I agree with
you that there is a perception problem, but it is one we are
working very hard to try and change.
Senator McCaskill. OK. Thank you.
Anyone who has anything they want to add, I am sure the
Chairman will allow them to submit it to the record.
The Chairman. Thank you so much, Senator McCaskill.
Senator McCaskill. Thank you, Senator.
The Chairman. We thank our witnesses. You shed a lot of
light on the issue and the topic, and it is really important.
We thank the first panel, also, and you can all look
forward to some progress on this matter.
So thank you for being here.
Mr. Sade. Thank you very much.
[Whereupon, at 12:16 p.m., the Committee was adjourned.]
A P P E N D I X
----------
Dr. Kassirer Responses to Senator Kohl's Questions
Question. Four years ago, the Office of the Inspector
General at the Department of Health and Human Services issued
ethics guidelines, in an effort to enforce its mandate to
investigate and prosecute illegal kickbacks to physicians from
drug companies. Do you think these guidelines have been
effective in curbing ethical conflicts?
Answer. In a highly unfortunate action, the Office of the
Inspector General failed to take an opportunity to strengthen
conflict of interest guidance. It merely accepted the
recommendations of PhRMA and the American Medical Association.
In my opinion, these recommendations are lax. They continue to
allow gifts and meals as well as participation by physicians in
industry speaker's bureaus and consultations on marketing
issues. Since their pronouncements in 2002, there have been no
apparent actions by the OIG on this issue. If these ethical
conflicts are to be curbed, the OIG will have to promote new,
more stringent guidance.
Question. The voluntary guidelines put into place by both
the medical industry and pharmaceutical industry several years
ago have done little to curb the excessive marketing to
physicians. In fact, the problem seems to be getting worse.
Since the guidelines were adopted, drug industry spending on
physician marketing has increased roughly $7 billion. If the
voluntary guidelines were mandatory and they were properly
enforced, would that be a good first step in cracking down on
the problem?
Answer. No. Because the voluntary guidelines of the
``medical industry'' and the pharmaceutical industry are so
deficient, even making them mandatory would have little effect.
Question. We've heard testimony about efforts to tighten
ethical guidelines in states, hospitals, and universities
around the country, for example the University of Wisconsin
Hospital banned free samples outright in 2001. What role should
the federal government play in limiting these conflicts of
interest and the troubling perceptions that they cause?
Answer. Free samples are ideally used for patients who
cannot afford them, but they often get into the wrong hands.
Nurses, technicians, and doctors often use them. In addition,
free samples are fundamentally marketing gimmicks, allowing
physicians to familiarize themselves with the newest and most
expensive drugs, and then to prescribe them. I believe all free
samples should be sent to a central repository and given out by
a voucher method to those who would benefit most from them. The
federal government could promote this practice.
Question. At the hearing, Dr. Lurie recommended a national
disclosure law to provide transparency of gifts and payments
physicians have received from drug companies, do you agree with
his recommendation and would disclosure of these gifts and
payments be an important first step in eliminating these
conflicts of interest?
Answer. In my testimony, I agreed that a federal registry
would be valuable, at least in identifying the physicians who
receive the largest payments from industry. But a registry
alone is not sufficient. We must have data that includes the
industry money that goes to professional organizations and lay
organizations, not just individual doctors. We need information
on what influence industry money has on medical organizations.
Question. After hearing the testimony of Dr. Rosenthal,
that these countless gifts and financial conflicts of every
kind have caused a rift in his corner of the medical
profession. At least some of his colleagues appear to be fed up
with the negative effects that this money is having upon
medical research. Do you perceive any evidence of a backlash or
revulsion by younger physicians or medical students against
accepting gifts, grants, trips, and honoraria of every
description?
Answer. The American Medical Student Association (no
connection to the AMA) has taken a strong stand against
students accepting gifts and food from industry. A Web site by
New York physician Bob Goodman (www.nofreelunch.org) has taken
a similar stand, and scattered across the country are students
who regularly eschew free gifts.
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Responses to Senator Kohl's Questions from Peter Lurie
Question. In your testimony, you recommend a national
disclosure law to provide transparency of gifts and payments
physicians have received. Who should administer this program
and be responsible for enforcing it?
Answer. We recommend that the database of payments to
physicians be maintained by the Department of Health and Human
Services (DHHS). The agency already has experience with a
similar national database, the National Practitioner Data Bank.
Moreover, the increased expenditures on drugs that ensue from
the industry's heavy reliance upon marketing are borne by the
Medicaid and Medicare programs, both of which are also housed
under DHHS. We would urge stiff penalties for instances of non-
compliance with any reporting requirement.
Question. Additionally, some states have exempted certain
things, such as drug samples or gifts under $100. Do you think
certain gifts or payments should be exempted from disclosure?
Answer. We believe that, as long as the nature of the
payments is clearly part of each disclosure, the public is
quite capable of distinguishing between, for example, payments
for research and those for elaborate meals. Let the information
be made public, in as detailed a fashion as is feasible, and
let the public decide for itself what it deems objectionable.
Sample, in particular, should not be exempted from disclosure,
as these are the single largest item in pharmaceutical company
expenditures on promotion. As noted in our testimony, three of
the five states with disclosure laws (District of Columbia,
Maine and Vermont) exempt payments under $25 and the remaining
two (Minnesota and West Virginia) exempt those under $100. We
would favor as low as exemption as possible. In Vermont, for
example, only 23% of payments over $25 exceeded $100 (Ross, et
al. JAMA 2007;297:1216-23), so high exemptions can result in
the loss of information about the majority of payments.
Question. The voluntary guidelines put into place by both
the medical industry and pharmaceutical industry several years
ago have done little to curb the excessive marketing to
physicians. In fact, the problem seems to be getting worse.
Since the guidelines were adopted, drug industry spending on
physician marketing has increased roughly $7 billion. If the
voluntary guidelines were mandatory and they were properly
enforced, would that eliminate the problem?
Answer. The underlying purpose of the medical and
pharmaceutical industry guidelines on gifts to physicians was
to preempt any federal or state legislation. We therefore have
no confidence that these codes will ever be enforced. We would
suggest that the Senate Special Committee on Aging ask the
industries to list all the enforcement actions they have taken
under their codes to date.
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