[Congressional Record Volume 146, Number 35 (Monday, March 27, 2000)]
[Extensions of Remarks]
[Pages E417-E419]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




         SAVE MONEY FOR PRESCRIPTION DRUG RESEARCH ACT OF 2000

                                 ______
                                 

                        HON. FORTNEY PETE STARK

                             of california

                    in the house of representatives

                         Monday, March 27, 2000

  Mr. STARK. Mr. Speaker, I rise today to introduce the Save Money for 
Prescription Drug

[[Page E418]]

Research Act of 2000, a bill to deny tax deductions to drug companies 
for certain gifts and benefits, but not product samples, provided to 
physicians and to encourage use of such funds for pharmaceutical 
research and development. Rather than spending pharmaceutical dollars 
on these very questionable gifts, the industry should devote these 
billions of dollars to research and development of life-saving drugs. 
This bill will enable them to do so.
  The magnitude of drug company bribes to doctors is staggering. In its 
January 19, 2000, issue, the Journal of the American Medical 
Association (JAMA) concluded that U.S. drug companies spend more than 
$11 billion per year on drug promotion and marketing--an estimated 
$8,000 to $13,000 per physician. These ``gifts'' include free meals, 
travel subsidies, sponsored teachings, and even recreational benefits 
such as sporting event tickets and golfing fees, to name just a few. 
The JAMA article is attached.
  JAMA's analysis warns that the present extent of these practices 
``appears to affect prescribing and professional behavior and should be 
further addressed at the level of policy and education.'' The $11 
billion that drug companies spend lobbying doctors often leads to 
distorted, inappropriate, overprescribing of drugs.
  Over the years, I have personally received numerous examples of drug 
company gift-giving to physicians. One physician has sent me many 
particularly outlandish examples of perks he has been offered. The 
number of gifts offered over the course of 1 week is staggering. One 
week included an invitation to the races--with a private suite, lunch, 
and open bar from noon to 3 p.m. Subsequent days of the week featured a 
free dinner at a fine restaurant where meals averaged $25/plate and 
major league baseball tickets for the entire family.
  I would also like to insert in the Record a March 9, 2000, USA Today 
article. This article describes a growing tend among advertising and 
marketing firms to sponsor physician continuing medical education 
courses that doctors in 34 States need to keep their licenses. These 
marketing firms are paid by drug companies and often hire faculty to 
teach courses and educate medical professionals about their sponsors' 
products. This provides drug companies with another opportunity to 
impact physician prescribing practice and increase their company 
profits--while giving doctors a free, questionable way to meet their 
recertification requirement.
  Drug companies will claim that changes in tax treatment will directly 
decrease their investment in research. In fact, less than 4 months ago 
the nonpartisan Congressional Research Service (CRS) analyzed the tax 
treatment of the pharmaceutical
  On top of their lowered tax rate, this industry already reaps 
billions and billions in profits every year. Fortune magazine rates the 
pharmaceutical industry as the most profitable business in America. The 
average compensation for 12 drug company CEO's was $22 million in 1998. 
Likewise, CRS reported that after-tax profits for the pharmaceutical 
industry averaged 17 percent--three times higher than the 5 percent 
profit margin of other industries.
  U.S. drug companies claim their exorbitant profits are justified by 
the high cost of research and development. Yet pharmaceutical companies 
generally spend twice as much on marketing and administration as they 
do on research and development. In fact, some companies are guilty of 
spending even more than that. Merck & Pfizer spent 11 percent of 
revenues on R&D in 1997, while spending 28 percent on administration 
and marketing--including gifts and promotions aimed at physicians.
  The pharmaceutical industry appears to have its priorities backward. 
Research and development is much more important than drug company 
promotions. Our nation has reaped great rewards as a result of 
pharmaceutical research; pharmaceutical and biotech research have led 
to the discovery of life-saving cures and treatments for ailments that 
would have cut lives short at one time. But drug companies can do more. 
Think of all the additional lives that could be saved if the 
pharmaceutical industry would dedicate the resources now spent on 
physician promotions to R&D.
  The need for this bill is clear. Denying the pharmaceutical industry 
the ability to deduct expenditures for gifts (other than product 
samples) to physicians is a critical step in providing Americans with 
access to more life-saving drugs. This will discourage drug company 
gifts that have been shown to sway physician prescribing behavior and 
free up more pharmaceutical revenue for R&D. By redirecting drug 
company promotional expenditures to their R&D budgets, the American 
public would reap the benefit of increased medical breakthroughs. If 
the companies choose to keep the $11 billion as company profits, then 
the additional tax revenue from these increases could be used to 
provide a much-needed Medicare prescription drug benefit. Any way you 
look at it, this bill is a winner for the American public.
  I look forward to working with my colleagues in support of this 
legislation to encourage pharmaceutical research and development and to 
deny drug company tax deductions for gifts to physicians.

                       [From JAMA, Jan. 19, 2000]

               Physicians and the Pharmaceutical Industry


                      Is a Gift Ever Just a Gift?

                         (By Ashley Wazana, MD)

       There are few issues in medicine that bring clinicians into 
     heated discussion as rapidly as the interaction between the 
     pharmaceutical industry and the medical profession. More than 
     $11 billion is spent each year by pharmaceutical companies in 
     promotion and marketing, $5 billion of which goes to sales 
     representatives. It has been estimated that $8000 to $13000 
     is spent per year on each physician. The attitudes about this 
     expensive interaction are divided and contradictory. One 
     study found that 85% of medical students believe it is 
     improper for politicians to accept a gift, whereas only 46% 
     found it improper for themselves to accept a gift of similar 
     value from the pharmaceutical company. Most medical 
     associations have published guidelines to address this 
     controversy. Perhaps the intensity of the discussion is 
     related to the potential consequences were it confirmed that 
     gifts influence prescription of medication that results in 
     increasing cost or negative health outcomes.
       This article addresses the question by way of a critical 
     examination of the evidence. Two review articles have 
     addressed the factors affecting drug prescribing, but only 1 
     has focused on the impact of the physician-industry 
     interaction on the behavior of physicians. This article 
     critically examines the literature and highlights articles 
     with rigorous study methods.


                                Methods

       Studies were identified by searching MEDLINE for articles 
     from 1994 to the present, using the expanded Medical Subject 
     Headings conflict of interest and drug industry, limiting the 
     search to articles in English while excluding review 
     articles, letters, and editorials; each identified study was 
     cross-referenced; a database of 400 articles gathered by the 
     Medical Lobby for Appropriate Marketing was searched; and 5 
     key informants were sought for their bibliographies on the 
     topic.
       A total of 538 studies that provided data on any of the 
     main study questions were targeted for retrieval. Of the 29 
     studies that were published in peer-reviewed journals and 
     identified as potentially relevant (containing quantitative 
     data on 1 of 3 facets of physician-industry interactions), 10 
     were from MEDLINE and 19 from other sources. The data 
     extractor (A.W.) was not blinded to the authors of the 
     studies.
       Those with an analytical design (having a comparison group) 
     were considered to be of higher methodological quality.
       Context. Controversy exists over the fact that physicians 
     have regular contact with the pharmaceutical industry and its 
     sales representatives, who spend a large sum of money each 
     year promoting to them by way of gifts, free meals, travel 
     subsidies, sponsored teachings, and symposia.
       Objective. To identify the extent of and attitudes toward 
     the relationship between physicians and the pharmaceutical 
     industry and its representatives and its impact on the 
     knowledge, attitudes, and behavior of physicians.
       Data Sources. A MEDLINE search was conducted for English-
     language articles published from 1994 to present, with review 
     of reference lists from retrieved articles; in addition, an 
     Internet database was searched and 5 key informants were 
     interviewed.
       Study Section. A total of 538 of studies that provided data 
     on any of the study questions were targeted for retrieval, 29 
     of which were included in the analysis.
       Data Extraction. Data were extracted by 1 author. Articles 
     using an analytic design were considered to be of high 
     methodological quality.
       Data Synthesis. Physician interactions with pharmaceutical 
     representatives were generally endorsed, began in medical 
     school, and continued at a rate of about 4 times per month. 
     Meetings with pharmaceutical representatives were associated 
     with requests by physicians for adding the drugs to the 
     hospital formulary and changes in prescribing practice. Drug 
     company-sponsored continuing medical education (CME) 
     preferentially highlighted the sponsor's drug(s) compared 
     with the CME programs. Attending sponsored CME events and 
     accepting funding for travel or lodging for educational 
     symposia were associated with increased prescription rates of 
     the sponsor's medication. Attending presentations given by 
     pharmaceutical representative speakers was also associated 
     with nonrational prescribing.
       Conclusion. The present extent of physician-industry 
     interactions appears to affect prescribing and professional 
     behavior and should be further addressed at the level of 
     policy and education.


[[Page E419]]


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                     [From USA Today, Mar. 9, 2000]

                      Who's Teaching the Doctors?


     drug firms sponsor required courses--and see their sales rise

                            (By Dan Vergano)

       At first glance, Harvard Medical School and advertising 
     giant Omnicom Group seem to have little in common. But they 
     share one trait: the right to award medical education credits 
     that doctors need to keep their licenses in 34 states.
       Omnicom, working through subsidiary Pragmaton, is one of a 
     growing number of advertising and marketing firms that 
     provide continuing medical education (CME) courses for 
     physicians. The firms are fully accredited, but because the 
     marketing firms often are working for pharmaceutical 
     companies, the practice increasingly is setting off ethical 
     alarms.
       ``It is unconscionable,'' says Catherine De Angelis, editor 
     in chief of the Journal of the American Medical Association.
       Marketing firms ``advertise wares under the guise of 
     medical education,'' she says.
       But advocates say commercial CME courses use faculty from 
     top medical schools, ensuring objectivity, while delivering 
     updates on drugs to the medical community more quickly than 
     academic educators.
       ``Companies live through education'' to ensure new products 
     are used appropriately, says Bert Spilker of the 
     Pharmaceutical Research and Manufacturers of America in 
     Washington, D.C.
       Without commercial CME firms, ``you won't find enough 
     Mother Teresas to provide everything doctors need,'' says 
     Michael Scotti, a CME official with the American Medical 
     Association. His organization is one of the seven medical 
     groups that charter the Chicago-based Accreditation Council 
     for Continuing Medical Education (ACCME), the office that 
     accredits courses nationwide.
       The drug companies provide ``unrestricted'' grants to the 
     marketers, who hire the course faculty. But growing numbers 
     of critics say there's nothing unrestricted about the 
     involvement of pharmaceutical companies.
       They fear that CME firms, which widely refer to course 
     sponsors as ``clients,'' stack their programs with faculty 
     physicians overly friendly to their sponsors' products. 
     Sponsors get a chance to market their products directly to 
     doctors in a venue disguised as education, critics say. In 
     fact, one company, Indianapolis-based Eli Lilly, is directly 
     accredited for CME, raising further concerns.
       Regulations going into effect in June promise higher 
     standards of separation between grant providers and course 
     faculty, but critics say they are weak and unenforceable. 
     Meanwhile, attempts to change the practice have been rebuffed 
     even as the number of commercial providers has increased. 
     Last spring, a resolution condemning accreditation of 
     commercial CME firms, signed by
       In February, a federal appeals court turned away the Food 
     and Drug Administration's latest bid for oversight of the CME 
     industry, reaffirming a decision made on freedom-of-speech 
     grounds.


                        patient's best interest?

       The concern comes at a time when pharmaceutical influence 
     on doctors is under scrutiny. A January study in the Journal 
     of the American Medical Association found that company-
     sponsored courses mentioned positive effects of the 
     companies' drugs 2.5 to 3 times more often than other 
     courses. Swayed by such marketing, doctors prescribed the 
     sponsors' drugs 5.5% to 18.7% more often afterward, according 
     to the study, without giving competitive products a similar 
     bounce.
       Critics fear that what's in the patient's best interest 
     won't always be the determining factor when a doctor 
     scribbles out a prescription.
       They point to firms such as an accredited company called 
     Interactive Medical Networks (IMN) of Rockville, Md., which 
     promises pharmaceutical companies ``a collaborative process 
     with a provider who shares your expectations'' on its Web 
     site (www.cmemuscle.com). In translation, that means 
     commercial grant providers can freely recommend faculty for 
     courses, IMN head Jan Perez says. ``If they're interested in 
     Dr. Jones or Dr. Smith, we try to work with them.''
       Under current conditions, ``it's up to doctors to identify 
     who's shilling for a company,'' says cardiologist Richard 
     Conti of the University of Florida at Gainesville, editor in 
     chief of Clinical Cardiology.
       Despite believing that the CME system works well overall, 
     Conti wrote an editorial last year calling for all providers 
     to have independent monitoring committees to ensure 
     objectivity.
       ``We recognize that concern,'' says Murray Kopelow, head of 
     the ACCME. Under the standards going into effect in June, 
     parent companies of commercial CME firms must possess a 
     mission ``congruent'' with medical education.
       Kopelow says commercial course providers will meet the 
     standards if they maintain a ``firewall'' between corporate 
     departments whose mission is selling advertising to drug 
     companies and the people preparing medical education courses.


                         Paying for the system

       Accredited course providers report about $900 million in 
     annual income to the ACCME. More than 40% of grant funding 
     from drug and medical device firms goes to the 25% of those 
     providers consisting of commercial organizations, not the 
     medical schools and societies that control other aspects of 
     physician training.
       ``We work the same way academic centers work'', says Dennis 
     Hoppe of Chicago-based Pragmaton. At the insistence of 
     clients, employees involved with education cannot have a role 
     in advertising activities. In addition, the company hires 
     external doctors and pharmacists to review programs for 
     objectivity.
       Pragmation has higher course standards than his hospital, 
     says psychiatrist Michael Easton of Rush Presbyterian St. 
     Luke's Medical Center in Chicago, a review board member.
       If the accrediting group arbitrarily banned commercial 
     firms from offering CME, it would result in a class-action 
     lawsuit aimed not only at the organization, but also against 
     critics, says Jack Angel, head of the Coalition for 
     Healthcare Communication, an industry trade group. ``As long 
     as we meet the same standards, we have a right to 
     participate,'' he says.
       ``Baloney,'' De Angelis says. ``Show me one of their 
     programs where (faculty) physicians push drugs not made by 
     the sponsor.''
       On the industry side, Angel says academic providers may be 
     complaining about commercial providers more for competitive 
     than altruistic reasons. ``They want more of the action.''


                        Few physician complaints

       In response to the dispute, Kopelow says, the ACCME has 
     considered requirements that independent monitoring 
     committees oversee all providers. But even with the new 
     standards, critics note other potential problems with the 
     group's oversight:
       Providers get to pick in advance which monitors review 
     courses for objectivity.
       No requirements ensure that physicians take courses 
     relevant to their specialties.
       No explicit requirement exists for physician involvement in 
     CME planning.
       ``We rely on faculty professionalism to a large extent,'' 
     Kopelow says. Industry participation in medicine is standard 
     practice, he says, citing such examples as for-profit 
     hospitals and health maintenance organizations as ``the way 
     we do things in the United States.'' Private companies 
     offering CME simply reflect that phenomenon, in his view.
       The required disclosure of who finances a course and of any 
     faculty ties to corporate sponsors goes a long way toward 
     ensuring doctors who take CME courses know where advice is 
     coming from, Kopelow says. ``We have millions of eyes out 
     there watching'' in some 600,000 annual hours of accredited 
     courses.
       Over the past three years his organization has received 56 
     complaints about programs, 14 resulting in warning letters. 
     But some point out that doctors who want to renew their 
     medical licenses have little incentive to call into question 
     a program that helps them reach that goal.
       ``Patients should be concerned about this,'' Glotzer says. 
     ``The job and responsibility of these firms is to market 
     drugs, not to teach doctors.''
       Disputes over industry involvement in medicine extend into 
     many areas, some physicians note.
       ``It's somewhat insulting to think that doctors don't have 
     inquiring minds that can tell the good from the bad,'' says 
     Dolores Bacon of New York Presbyterian Medical Center.
       ``There's a huge variability in commercial (CME) 
     programs,'' she adds. ``Ultimately, as physicians, our job is 
     to be informed consumers.

     

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