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PrescriptionDrugAdvertising:

PrescriptionDrugAdvertising:Is it a problem for you andyour patients?

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MetroDoctors The Journal of the Hennepin and Ramsey Medical Societies March/April 2000 1

V O L U M E 2 , N O . 2 M A R C H / A P R I L 2 0 0 0

C O N T E N T SPhysician Co-editor Thomas B. Dunkel, M.D.Physician Co-editor Richard J. Morris, M.D.Managing Editor Nancy K. BauerAssistant Editor Doreen HinesHMS CEO Jack G. DavisRMS CEO Roger K. JohnsonProduction Manager Sheila A. HatcherAdvertising Manager Dustin J. RossowCover Design by Susan Reed

MetroDoctors (ISSN 1526-4262) is published bi-monthly by the Hennepin and Ramsey MedicalSocieties, 3433 Broadway Street NE, BroadwayPlace East, Suite 325, Minneapolis, MN 55413-1761. Periodical postage paid at Minneapolis,Minnesota. Postmaster: Send address changes toMetroDoctors, Hennepin and Ramsey MedicalSocieties, 3433 Broadway Street NE, BroadwayPlace East, Suite 325, Minneapolis, MN 55413-1761.

To promote their objectives and services, theHennepin and Ramsey Medical Societies printinformation in MetroDoctors regarding activitiesand interests of the societies. Responsibility is notassumed for opinions expressed or implied insigned articles, and because of the freedom givento contributors, opinions may not necessarilyreflect the official position of HMS or RMS.

Send letters and other materials for considerationto MetroDoctors, Hennepin and Ramsey MedicalSocieties, 3433 Broadway Street NE, BroadwayPlace East, Suite 325, Minneapolis, MN 55413-1761. E-mail: [email protected].

For advertising rates and space reservations,contact Dustin J. Rossow, 4200 Parklawn Ave.,#103, Edina, MN 55435; phone: (612) 831-3280; fax: (612) 831-3260; e-mail:[email protected].

MetroDoctors reserves the right to reject anyarticle or advertising copy not in accordance witheditorial policy.

Non-members may subscribe to MetroDoctors at acost of $15 per year or $3 per issue, if extra copiesare available.

2 LETTERS

5 PHYSICIAN’S SOAP BOXKimberly Anderson, M.D.

7 Overview of Direct to Consumer Advertising

10 FEATURE: DIRECT TO CONSUMER ADVERTISINGPhysicians are Beginning to Experience the Effects

14 COLLEAGUE INTERVIEWRichard Simmons, M.D.

16 Prescription Drug Access, Marketing: Top Issues for Minnesotans

17 Direct to Consumer Advertising Helps Patients

18 Pharmacists Feel the Effects of Direct to Consumer Advertising

19 Regulatory Issues with Dietary Supplements

23 NOTEWORTHY

23 CLASSIFIED ADS

RAMSEY MEDICAL SOCIETY

24 President’s Message

25 RMS Alliance

26 RMS News

27 Applicants for Membership/In Memoriam

HENNEPIN MEDICAL SOCIETY

29 HMS In Action

30 HMS Plans for the Future

31 In Memoriam

32 HMS Alliance

On the cover: Prescription Drug Advertising: Is ita problem for you and your patients?

2 March/April 2000 MetroDoctors The Journal of the Hennepin and Ramsey Medical Societies

After the January/February edition ofMetroDoctors went to press, an addi-tional question regarding health planliability was posed to Lori Swanson. Thefollowing is her response.

Dear Editor:If the patient and doctor disagree with theHMO’s decision to restrict care, whatoptions exist under the law to adjudicatethe dispute before any harm could occur?

While many medical claims are paidwithout a hitch, disputes can arise whenhealth plans refuse to pay for treatmentrecommended to a patient by his or hertreating physician. When this happens, it isimportant that the patient be aggressive in

protecting his or her legitimate rights tocoverage. Unfortunately, these denials oftencome when the patient is sick and least able tofight back. Accordingly, the doctor can be animportant advocate in helping the patient toget the coverage that the patient deserves.

Most health plans have an appeal processwhich can be used by patients whose claimsare denied. While the deck is often stackedagainst the patient (since the decision-makeron the appeal is typically the same companythat already denied coverage), appeals cansometimes work. In the event that treatmentis needed on an emergency basis, or there is alimited window of opportunity within whichthe patient must receive treatment, the patientshould ask that the health plan treat theappeal on a “rush” basis.

In addition, in 1999 the MinnesotaLegislature enacted an external review bill.Under this measure, patients may, effectiveApril 1, 2000, file a request that a denial ofcare be externally reviewed. The MinnesotaDepartment of Administration will enter intoa contract with at least one outside externalreviewer to perform such reviews. The resultsof the external review are binding on thehealth plan but not on the patient. Becausethe external review law is not yet effective, it isstill unclear precisely how the process willwork.

Likewise, a patient whose claim has beendenied by an HMO may also file a lawsuit torequire the health plan to provide coverage. Incases involving access to life-saving medicaltreatment, the lawsuit may request injunctiverelief requiring the health plan to immediatelyprovide coverage.

Attorney General Mike Hatch haspublished a 35-page booklet entitled,Managing Managed Health Care to assistpatients in navigating the health carebureaucracy. This free guide is available fromthe Attorney General’s Office by writing orcalling the Office of Minnesota AttorneyGeneral Mike Hatch, 1400 NCL Tower, 445Minnesota Street, St. Paul, MN 55101-2131;ph. 800-657-3787 or (651) 296-3353. ✦

Sincerely,LORI R. SWANSONDeputy Attorney GeneralOffice of Minnesota

L E T T E R S

MetroDoctors welcomes letters tothe editor. Send yours to:

Nancy K. Bauer, Managing EditorMetroDoctorsHennepin & Ramsey Medical SocietiesBroadway Place East, Suite 3253433 Broadway St. NEMinneapolis, MN 55413-1761

Fax: (612) 623-2888E-mail: [email protected]




A

B Y K I M B E R L Y A N D E R S O N , M . D .

P H Y S I C I A N ' S S O A P B O X

AS A PRIMARY CARE PHYSICIAN, I am used to spending extratime and effort to help HMOs save money. My patients must switchmedications to reflect HMOs “flavor of the month” formulary orelse suffer the penalty of paying extra at the drugstore. Theseformulary meds are usually determined on a cost basis — that iswhatever drug company offers a better deal to the HMOs. So, theHMO changes the formulary, and we, as physicians, get the phonecalls from the pharmacists to approve substitutions, then sometimesa phone call from the patient who feels uneasy about changing fromtheir known med to something new to them. When the medication

alternatives are not acceptable to the patient’s care the physicianmust explain in writing.

Recently I had a very unsettling experience. I received a list ofmy patients who were to switch brands of “statins” and ace inhibi-tors compliments of “PCS Clinical Counseling.” I approved thechanges when I could, and assumed that the relevant pharmacieswould be contacted with the changes. I pictured this as preventingmy patients having to wait at the pharmacy while the pharmacistseeks approval. Instead, several days later I got several phone callsfrom my patients about a “letter” I had sent them. It seems the“clinical consultant” who I had never even met, sent my patients aletter in the first person describing the medication change andsigned my name at the bottom! He also took the liberty of tellingmy patients to call for an appointment to see me in the office in aninterval of time that he designated. The aggressiveness is unbeliev-able! I spoke with him and his manager and got an unimpressiveapology and a promise that the consultant would work much closerwith me. No thanks! ✦

Kimberly A. Anderson, M.D., is board certified in internal medicine, and isin private practice at Adult Medicine, P.A., in St. Paul.

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T

Overview of Direct to Consumer Advertising

THE FACT IS THAT THE DIRECT to Con-sumer (DTC) advertisements are increasing infrequency and are far from going away anytimein the near future. Whether you feel these adsare right or wrong, they seem to be affecting allaspects of the physician/patient relationship. Thetrend is obvious by merely watching an evening’sworth of television, or paging through just aboutany type of magazine. DTC ads are becomingmore entertaining and humorous. It has beenstated that the successful medication will de-pend on its marketing team as much as its owncapability to treat a disease.

There are positive and negative aspects withthis trend by the pharmaceutical industry toempower patients with information on new (andin many cases, very expensive) treatments. DTCads are everywhere these days (magazines,internet, newspapers, and television) and it isaffecting both patients and providers in manydifferent facets. In this article we will providesome background on the history of DTC adsand review the marketing trends developing inthe pharmaceutical industry. We will also lookat the positive and negative effects of this newtype of information source for our patients.

Between 1983 and 1985, the Food andDrug Administration (FDA) imposed a mora-torium on pharmaceutical companies advertis-ing to the patient. The DTC ads after this timeperiod were able to allude to a therapeutic op-tion for treatment of a particular disease statebut not allowed to associate a drug name anddisease state. Typically, a toll-free number wasgiven for a consumer to obtain further infor-mation and they were advised to consult theirphysician for further information.

The first DTC ad on television was for a

nicotine patch during the Super Bowl game of1992. The results were that the demand for theproduct quickly exceeded the supply — a dreamfor any company providing a product. Many phar-maceutical companies kept close tabs on the ef-fects of this first ad and then followed the example.

Since the FDA lifted its moratorium onDTC advertising for prescription medicationsin 1985, there has been an increasing emphasison creating consumer demand for medicationsby the pharmaceutical industry. In August 1997,the FDA allowed broadcasts to disclose both thename of specific products and the conditionwhich they are intended to treat with the fol-lowing requirements.• Advertising must not be misleading.• Advertising must contain a major state-

ment disclosing all major risks associatedwith a particular drug.

• Advertising must contain a toll-free num-ber, a reference to a print ad and/or a webaddress to obtain full product labeling.

• Advertising must contain a statement thatphysicians or pharmacists can provide ad-ditional information.Pharmaceutical spending on DTC ads has

increased from $20 million in 1989, to over$1.32 billion for 1998. DTC ads are projectedto increase over 50 percent in 1999 to $2 bil-lion. This represents a 60 percent annual growthrate since 1989 in DTC ad spending.

Pharmaceutical companies still spend 75percent of the industry’s advertising budget ondirect contact with providers and advertising inmedical journals. Even though the majority ofthe budget remains targeted at the provider, ithas only increased by 20 percent in 1998. In1997 and 1998, $3.42 billion and $4.10 billionrespectively, were spent in this area of advertis-ing. It is interesting to note that the top ten DTCspending branded medications are using the

majority of their marketing budget to provideinformation to the consumer rather than theprovider.

Since the relaxed stance by the FDA onDTC ads, it is clear that the trend is increasingand does not appear to be going away or haveany reason to diminish soon.

It seems obvious that DTC advertisingbenefits the pharmaceutical company throughimproved market share and name recognition,but it is still hard to evaluate the dollar for dol-lar value of DTC advertising. This informationis not readily available at this time. IMS Health(IMS), a group that does have some reportingcapabilities in this area, evaluates the impact ofDTC investment on branded medications andits effect on market share growth. The key pur-chasers of this information have been the phar-maceutical companies as part of the effort toevaluate the impact of DTC advertising onmarket share. The information available in newsreleases, journals, and surveys of providers andconsumers does suggest that it is having an ef-fect on prescription and sales volume. Schering-Plough spent $67-$83 on DTC ads for eachnew Claritin® prescription generated from thefirst quarter of 1997 to first quarter of 1998.This added over 450,000 new prescriptionsduring this time period. Pfizer added 110,000new Zrytec® prescriptions during this same timeperiod costing the pharmaceutical company$156-$241 for each new prescription. These

(Continued on page 8)

Industry Spending (1998)

$17 billion — Research and development$8.3 billion — Product promotion$7.0 billion — Health professional education$1.3 billion — DTC promotion

B Y R O B E R T C . M O R A V E C , M.D.A N D D O N N A B O R E E N , Pharm.D.


(Continued from page 7)

numbers suggest that money spent on DTCads does move market share. Another effect ofDTC ads is that the new medications released inthe market today are being propelled to the “Top200” list at a much faster rate than ever before.

All of these aspects would obviously beconsidered a benefit for the pharmaceutical com-pany. What are the benefits for the patient? Con-sumers have had an increasing desire for infor-mation to make better choices about their ownhealthcare. DTC ads are fulfilling this demandby empowering and educating them abouthealth conditions and possible treatments. Pre-vention Magazine found in a national surveyconducted during 1998 that:• More than 53 million patients had a dis-

cussion with their physician about a medi-cine they saw advertised. This is felt toimprove public health due to the frequencyof under-diagnosed and under-treated dis-ease states.

• DTC ads also encouraged a projected 21.2million patients to discuss a medical con-dition with their physician that they wouldnot have brought up prior to seeing theDTC ad.

• As many as 12.1 million patients receiveda prescribed medication as a direct resultof viewing the DTC ad.

• DTC ads may also be associated with improvedpatient compliance. Seeing their medica-tions advertised on television seems to vali-date what their physician has prescribed.

The risk to the patient seems to be:• Unrealistic expectations of the capabilities

of the medication.• Incomplete information in regards to the

medication and its capabilities.• The cost of new medications does not de-

crease with expanded drug usage. Being ableto afford new medications is a concern formost patients — especially the elderly.Recently, Consumer Reports reviewed this

issue and concluded that DTC ads are felt notto be in the best interest of the public, but rathermeant to move a product. This report also ac-cessed the reliability of DTC ads. They felt thatthey provided little educational benefit and over-all quality was poor.

Because of the relatively recent approachto heavily promoting products on television,there has been little research regarding the over-all outcomes of DTC marketing. Proponentsof DTC advertising point out the followingpositive impacts:• DTC advertising provides valuable educa-

tional information to patients and helpsidentify and motivate patients with undertreated conditions to seek appropriatemedical attention.

• Informs patients regarding new therapiesand options.

• Creates a more informed consumer/patientwhich results in a more collaborative phy-sician-patient relationship.

• Improves patient compliance with someforms of therapy.

• Provides a general acceptance of some

medical conditions as legitimate for discus-sion with doctors and reduces the overallnegative bias of some medical conditions.Critics of DTC advertising point out that

the winners of the “pharmaceutical drug war”won’t necessarily be the best products but ratherthe best advertising campaign. In addition, DTCadvertising might have the following negativeimpacts:• It creates consumer demand at a time of

diminishing health plan resources.• Undermines the physician-patient relation-

ship by creating the doctor as the middleman when patients are requesting specificmedications that might not be appropri-ate or on the health plan formulary.

• A tendency for DTC advertising to be falseand misleading by providing evidence whichsupports advertising claims and disregard-ing evidence which does not support claims.

• Increasing the potential for adverse drugreactions.

Physician response to specificrequests by a patient:What is the best way to respond when a patientasks for a specific medication or brings in a printad for their conditions? A natural, and oftenwrong, response is to say, “No” or to disregardthe patient’s request outright. The potential foran adversarial relationship is increased when thepatient feels that they are not listened to andthat their specific requests are not adequatelyaddressed in a discussion with their physician.Potentially that patient might seek out alterna-tive care or lose trust in the physician.

It is probably best to listen carefully to thepatient’s request and establish empathy. If youare not sure about the appropriateness of themedication, keep your options open and holdyour opinion for later.

Recognize the request from the patient’sperspective. The patient is trying to be an in-formed consumer and participate in their ownhealth care decisions. Give the patient credit andask where they heard about the medication. Itis also appropriate to ask why the patient pre-fers the advertised drug. Many patients havedone quite a bit of research into their specificcondition and are incredibly informed consum-ers of health care. Feel free to discuss options oftreatment that include the price of the drug,indications and side effects, adverse drug reac-tions and overall efficacy.

Table 1: Allocations of advertising budgetfor the top 10 DTC products in 1998.

Product Company DTC $ Professional $(in millions) (in millions)

Claritin® Schering-Plough 185 82

Propecia® Merck 92 19

Zrytec® Pfizer 72 54

Zyban® Glaxo-Wellcome 64 21

Pravachol® Bristol Meyer Squibb 60 50

Allegra® Hoerchst Marion Roussel 53 61

Prilosec® Astra 50 52

Zocor® Merck 44 46

Evista® Eli Lilly 42 51

Prozac® Eli Lilly 41 60


Try to work with the patient’s knowledgeand not against it. Generally, within a 15 minuteoffice visit, a collaboration with the patient takesless time than confrontation. Remember thatthis is not a challenge of authority but moreoften a legitimate request to be considered.

As a health care professional, it is a goodidea to help monitor the ads that you see eitherin print or on television. Report to the FDAincidences of misleading ads and its effect onpatients. Medical professionals must be com-mitted to provide feedback. There is little theFDA has in the way of evidence regarding theharms or benefits of DTC advertising. Physi-cians must be committed to providing feedbackregarding the fair and balanced discussion ofdrug use and the adequacy of explanations re-garding warnings, adverse drug reactions andprecautions as well as the overall compliancewith the FDA rules.

The FDA is currently looking at ways totighten up the regulations and require compa-nies to design ads that help promote the physi-cian-patient relationship. Pharmaceutical com-panies should be asked to include physicians inthe rolling out of an ad campaign. This couldoccur by a letter to physicians about ads priorto a specific ad release. This would help the doc-tor become more informed and to anticipatespecific questions that might come up duringclinical visits.

Finally, recognize that “participatory healthcare” is changing the nature of the physician-patient relationship. The ideal physician-patientrelationship is based on a mutual partnership.Consumers and patients are seeking increasedinformation from a variety of sources includingthe internet, libraries and resource centers andDTC advertising. This mutual partnershipshould be utilized by the physician for betterpatient compliance, hopefully resulting in im-proved patient outcomes. ✦

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F E A T U R E S T O R Y

A

D i re c t l y t o C o n s u m e r s

Pharmaceutical Companies are

Advertising Prescription Drugs

and Physicians are Beginning to

Experience the Effects

“I often end up

explaining the

difference be-

tween the hype

and the actual

benefit — or

downside — of

a drug.”Anthony Woolley, M.D.

A LAZY AFTERNOON OF WATCHING TELEVISION once meant bumping into medicalads promising relief from minor aches and pains. A middle-aged man in pajamas mightstare blankly into the camera and say, “I can’t believe I ate the whole thing.” Whether oneactually bought the product, and whether it worked, had little impact on public health.

All that changed in August 1997 when the Food and Drug Administration (FDA)began allowing pharmaceutical companies to advertise prescription drugs. These Directto Consumer (DTC) ads have proliferated, filling magazines, newspapers, radio, and tele-vision airwaves at the rate of about $1.8 billion in 1999.

Everyday ailments such as headaches, dry skin and athlete’s foot have given way to anew crop of ads that often take on life’s big problems: anxiety disorders, weight loss, andmigraines. In one such commercial, a female cartoon character tells viewers, “I feel anx-ious. I can’t concentrate.” as the words float across the screen. Soon, a voice is proclaimingthe wonders of Buspar®, an anti-anxiety drug, and the woman’s words, and worries, areliterally swept away.

But for many physicians, the troubles associated with these ads are just beginning.It’s not unusual for Dr. Anthony Woolley, who specializes in internal medicine at

Park Nicollet Medical Center in St. Louis Park, to spend several minutes of a patient visitdebunking the alleged virtues of a particular drug.

“I often end up explaining the difference between the hype and the actual benefit —or downside — of a drug,” Woolley says. “Generally, patients lose interest pretty quickly.”

According to a recent FDA survey, 27 percent of patients admit being influenced byadvertising to see a physician for an as-yet-untreated ailment. A small percentage, aboutseven percent, asked for a specific drug after being prompted by an ad.

The rising number of patient requests for specific drugs has several implications, saypracticing physicians and other health care professionals. Pharmaceutical companies tendto spend the majority of advertising dollars on their newest offerings. These medications,by their very nature, are the least-tested and most-expensive drugs in their product categories.

Editor’s Note: This issue of MetroDoctors focuses on the various aspects of Direct to Consumer(DTC) marketing by the pharmaceutical companies and its effect on patients, physicians,and pharmacists. Feel free to share any of the information contained in this issue with yourpatients.

B Y T O D D M E L B Y


“Providing

information to

consumers is

a good thing,

but Direct to

Consumer

advertising is

not a good

thing.”Ila Harris, Pharm.D.


That doesn’t stop patients from making requests. A man visiting a resident at BethesdaClinic in St. Paul recently suggested the young doctor write him a prescription for Prilosec®,a drug that fights heartburn and ulcers. Luckily, the resident was aware that generic Zantac®,which is approximately seven times less expensive, would probably work just as well.

“Patients often come in and insist on a more expensive drug that they just saw in acommercial,” says Ila Harris, a Pharm.D. at the clinic who works with resident physicians.Harris is a professor in both the pharmacy and medical schools at the University of Min-nesota.

“Providing information to consumers is a good thing, but Direct to Consumer adver-tising is not a good thing,” Harris adds. “It provides a bias.” People see the commercials,and come in asking for that specific drug. Sometimes residents approach Harris, saying,“They’re asking for Relenza®, what do you think?” In Relenza® print ads, the new flu drugfeatures photos of the actor who portrayed Newman, the zany postal worker on the hitshow “Seinfeld” in fake police mug shots.

Harris doesn’t always get the chance to steer residents in what she thinks is the rightdirection. A prescription for a widely-promoted, but expensive drug, occasionally makesits way to the pharmacy before she can intervene. According to Harris, “Sometimes it’sdone without much thought.”

It’s not only beginners that succumb to frequent requests for “As Seen On TV” drugs.When asked for an example of a rushed physician who has prescribed a pricey, heavily-promoted drug, Dr. Jamie Peters said, “I haven’t just heard about it. I’ve done it… I’m notsaying it’s something I’m proud of.”

Peters, a professor at the University of Minnesota who practices at Smiley’s Clinic insouth Minneapolis, is opposed to DTC pharmaceutical advertising.

“Pharmaceutical companies are creating a demand for more expensive drugs throughadvertising. That’s what advertising does: create demand,” Peters says. “If money goes toexpensive drugs, there’s not money left for other things.”

Many of the new drugs aren’t just slightly more expensive, either. Celebrex® andZioxx®, both new arthritis fighters, each cost patients about $68 for a one-month pre-scription. The generic Ibuprofen produces similar results at about one-fourth the cost.Patients, however, are often isolated from costs associated with higher-priced drugs be-cause HMO co-pays are often only $10 or $15 per prescription.

That may be changing. About 1,000 employees at Land O’Lakes, Inc., an ArdenHills-based company, now face a 25 percent co-pay on prescription drugs, with a maxi-


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mum $20 hit. The new policy, which took effect Jan. 1 for em-ployees in the Choice Plus plan, is an attempt to stem rising drugcosts, says Terry Koves, director of compensation and benefits.

Prescription drug spending at Land O’ Lakes comprised 24percent of employee medical expenses in 1999. That’s a far cryfrom the five to seven percent doled out in 1991. Koves believesDTC advertising has contributed to those rising costs.

“I’m concerned that there’s pressure on doctors to do some-thing they normally wouldn’t do,” Koves says. “It’s changed thewhole dynamic of medical practice as we see it.”

Professional organizations have jumped into the fray. Boththe American Medical Association (AMA) and the American As-sociation of Family Physicians have promised to study the reasonsbehind rising drug expenditures, with the AMA focusing on thespecific effect of DTC ads.

Not every physician is wary of the new wave of drug ads.“I have no problem with it,” says Dr. Charles Terzian, who

practices internal medicine at Allina Medical Clinic in downtownMinneapolis. “It has benefits and downfalls. Sometimes the more

expensive medicine might be the better medicine.”Claritin®, unlike many cheaper antihistamines that minimize

the physical effects of allergies and colds, doesn’t make most pa-tients sleepy. Although it’s far more expensive than its competi-tors, Terzian prefers it.

“Should people with colds be knocked out?” Terzian asks. “I’drather prescribe a little more expensive medication and keep themworking and more productive… Too often people look at the costand not the quality of the drug.”

Terzian also favors Zithromax® for many people in need of anantibiotic. Although its cost is higher, it doesn’t need to be taken asfrequently as other medications.

“What do you think my compliance is going to be?” Terzianasks rhetorically.

Not surprisingly, Alan F. Holmer, Pharmaceutical Researchand Manufacturers of America president, supports DTC.

“Pharmaceutical companies have both a right and a responsi-bility to inform people about their products under the supervisionof the FDA, which regulates prescription drug advertising,” Holmerwrote in the Journal of the American Medical Association (JAMA)last year. “While such advertising prompts more people to seekprofessional help, it does not dictate the outcome of the physician


visit or the kind of help patients eventually receive.”A 1998 study in Prevention magazine found that DTC adver-

tising “encouraged a projected 21.2 million consumers to talk withtheir doctor about a medical condition or illness they had nevertalked with their doctor about before seeing the advertising.”

What if a doctor turns down a patient request for a particulardrug? Another survey, this one of randomly selected residents ofSacramento, Calif., asked respondents what steps they would takeif a physician turned down their request for a specific medication.About 25 percent said they’d go elsewhere in search of the drug,while 15 percent said they’d consider switching doctors.

One group of people that is particularly assertive are thoseseeking a quick fix for obesity. After seeing ads for Orlistat® orXenical®, some patients seem reluctant to give up hope in the won-der drugs they’ve seen advertised. Even after being told about un-pleasant side effects like fecal incontinence.

“Weight loss medication is the exception,” says Dr. Woolley.“These people are very interested, almost insistent (that they beprescribed the drug), despite what you tell them.”

Despite the pros and cons of DTC, one can be certain that itis here to stay. Patients are taking their health and this new level ofinformation seriously. They will continue to challenge their pro-

viders about their diagnosis and treatment plan armed with adver-tisements and research. ✦

Todd Melby is a freelance writer.

National Organizations Take Actionto Study Pharmaceutical Costs

The American Medical Association and the AmericanAssociation of Family Physicians both recently adoptedresolutions that will study the skyrocketing costs of phar-maceuticals. The AMA study will address: the interna-tional differences in prices paid for identical drugs; theintroduction of new pharmaceuticals that are signifi-cantly more expensive than the ones they replace; directto consumer advertising; lifestyle drugs such as Viagra®,Propecia®, etc.; and the bioavailability, equivalency andefficacy of generic drugs.

C O L L E A G U E I N T E R V I E W


AQ

Richard Simmons, M.D.

Editor’s Note: “Colleague Interview” provides HMS and RMS mem-bers with an opportunity to ask questions of their colleagues who arein unique roles. Dr. Simmons is Medical Director, Medica. In thiscapacity he provides input and works closely with Medica’s Pharmacy& Therapeutics Committee.

What effect has Direct to Consumer (DTC) marketing bypharmaceutical manufacturers had on Medica?

It is our opinion that DTC advertising has had a marked effect in increas-ing the average number of prescriptions per member filled per year; i.e.,1997=6.44 1998=6.70 1999=6.95.

To what degree have increased costs for pharmaceuticalscontributed to the overall increase in health care costs?

The percent increase of total health care costs for Medica was 20 percentin 1999 over 1998. The pharmaceutical portion of this increase was 16.1percent.

The FDA approval process is much quicker than it was justa few years ago, resulting in up to 190+ new compounds ayear being approved. How does a health plan manage theprocess of evaluating this many new drugs each year?

In 1999, the FDA approved 83 new drugs. Of these, 35 were new chemi-cals and five were new biologic compounds. Our Pharmacy and Thera-peutics Committee reviews each new approval.

In addition to the existing drug formularies and educationprograms, will Medica be attempting to introduce newprograms to control pharmaceutical costs?

Medica is establishing many programs attempting to control the escala-tion of drug costs, some of which are individual and clinic profiles, cliniceducational programs led by Medica’s in house Pharm.D. MargaretSchmidt, articles in Connections, articles in member newsletters, specificcontracts with manufacturers, etc.

Has Medica considered a patient education program tocounter the direct consumer advertising of the pharmaceu-tical companies?

We anticipate that during the next year or two, Medica will include phar-macy-related articles in every member newsletter.

Assuming that in the physician’s judgement the patient’ssituation requires going off formulary. What procedureshould the physician use to get the necessary approval?

Approximately 75 percent of Medica members who have pharmacy ben-efits within their contracts have a second tier option. This allows mem-bers to obtain nonformulary drugs for an increased co-pay.

There recently was a mailing to Medica patients invitingthem to ask their physician about changing their prescrip-tion to Lipitor. Why is this type of mailing being sent topatients and not their physicians?

This is an example of Medica’s attempt to educate members to the avail-ability of a potentially superior drug and at the same time a lower costdrug to Medica. This is truly a win/win situation.


Does Medica contract with a PBM to manage its drugbenefit? If yes, which one?

Medica’s pharmacy benefit management organization is Express Scripts/DPS. It should be understood, however, that Medica alone chooses thedrugs on Medica’s formulary.

Does Medica collect prescribing profiles for its participatingphysicians? If yes, describe how this information is used.Does Medica transfer this information either directly orthrough a PBM to a third party?

Medica has obtained physician specific prescribing profiles for some phy-sicians in a pilot project. This information was only used for educationalpurposes. Medica obtains this information from its PBM and Medicadoes not transfer it to any third party.

How does Medica plan to publicize its formulary?

Medica has just completed distributing its year 2000 formulary. If youdid not receive it, please call 1-800-458-5512 or (612) 992-2232. In ad-dition, the Council of Health Plans has distributed a compilation formu-lary every six months for the past three years. The current formulary canbe obtained from Medica’s web site at www.medica.com.

Do you think the Federal Government should exert somecontrol over pharmaceutical pricing?

Speaking personally, I am apprehensive about any more government con-trols in the area of health care. That being said, organized medicine inconjunction with managed care has the potential to dramatically slowthe pharmaceutical cost trend.

Do you have any other thoughts on what seems to be anout of control pharmaceutical marketplace?

Medica, as part of the managed care community, is very concerned withthe escalation of drug costs. Although it has not yet happened here, insome areas of our country prescription costs are larger than in-patientcare. For example, in some plans, 23+ percent of the health care cost “pie”are prescription costs; while at Medica, at present, prescription costs are19 percent of the total.

I personally am very concerned that if the present trend increase contin-ues, the prescription benefit will no longer be offered. Many physicians,including myself, believe there should be an increased sharing of respon-sibility for the increasing cost of health care between patients, employers,health plans, and practitioners. Because of state regulations, the increasedsharing of drug costs is not easily accomplished. Unfortunately, “the skyis falling” is an unpleasant message; however, we must also be realistic. ✦


P

Prescription Drug Access, Marketing:Top Issues for Minnesotans

B Y B I L L L U T H E RC o n g r e s s m a n , M i n n e s o t a 6 t h D i s t r i c t

PRESCRIPTION DRUGS are increasingly be-coming one of the most hotly contested issueson Capitol Hill. Seniors’ groups are calling for aprescription drug benefit under Medicare, mem-bers of Congress are sorting through a vast ar-ray of reform proposals, and drug companiesare working to maintain their profit margins. Ifnothing else, the millions of dollars that thepharmaceutical companies spend on lobbyingefforts and advertising indicate just how signifi-cant this issue is, and just how much is at stake.Although change is often slow to come in Wash-ington, it appears that the time for real reformon the prescription drug issue is edging nearer.

My work on prescription drugs has at-tracted the attention of more people than justthe seniors in Minnesota. Citizens for BetterMedicare, a group primarily funded by the Phar-maceutical Research Manufacturers of America(PhRMA), launched a multi-million dollar at-tack campaign aimed at my work to make medi-cine more affordable for seniors. The deceptiveads (conducted through a front group) misrep-resented my efforts to make medicine afford-able for the seniors who need it. The simple factthat the pharmaceutical industry was willing topour millions of dollars into a deceptive attackagainst me calls into question the industry’s cred-ibility on this issue. And clearly, consumers havethe most to lose if nothing is done to changethe way we handle prescription drugs.

The Direct to Consumer (DTC) market-ing of prescription medication is yet anotheremerging issue relating to cost and appropriatecare. DTC advertising has proven to be ex-tremely successful in efforts by manufacturersto essentially “override the middleman,” thephysician, and convince patients that they need

one particular drug even if a trained health pro-fessional believes some other drug would beequally or more effective, oftentimes at a lowercost. Drug companies spent more than a bil-lion dollars on television, print, and radio ad-vertisements in 1999 alone. This type of mar-keting is very controversial, and for good rea-son. The aggressive marketing of pharmaceuti-cals is costly, and it is ultimately the consumerwho ends up footing the bill through higher- training to understand this complex technical

medical information. Research also has dem-onstrated that DTC ads often steer individualsaway from generics or older, more reliable medi-cation and toward the latest, and usually moreexpensive, brand-name drugs. This drives up thecost of medication even higher, and does notnecessarily provide better treatment of a healthcondition. Worse yet, the net effect of DTCmarketing is oftentimes to create unnecessaryfriction between a patient and his or her doctorover appropriate treatment. Madison Avenue ad-vertising should not replace or undermine thecritically important doctor-patient relationship.

It is not likely that pharmaceutical com-panies will end all direct marketing to consum-ers. Change, however, is essential to ensure thatconsumers have access to information that isaccurate and fully discloses the risks and effi-cacy of advertised drugs, as well as informationabout other medication or treatments that couldwork just as well. I recognize that this is a veryserious issue, and that it may need to be ad-dressed legislatively. It is my hope that Congresswill act to protect consumers so that they areable to make, and have access to, the best pos-sible health care choices. As we begin to seri-ously review this issue in Congress, I believe asa first priority we must ensure that the patients’interests are being served. With the help of con-cerned consumers and health professionals, I amdedicated to helping make this happen. ✦

priced medication. Moreover, while it is impor-tant to give consumers choices in their healthcare decisions, in order to make sound choicesthey need accurate and dependable information.Unfortunately, the FDA does not require thatthe product labeling be written in language thatmost consumers can understand. In fact, mostof the information accompanying prescriptiondrugs is written for healthcare professionals. Theaverage consumer does not have the time or the

Worse yet,the net effect ofDTC marketing is

oftentimes tocreate unnecessaryfriction between a

patient and hisor her doctor

over appropriatetreatment.


M

Direct to Consumer AdvertisingHelps Patients

MORE THAN EVER, patients are taking con-trol of their own health destinies. The consumermovement and the information explosion haveempowered patients to participate in decisionsconcerning their health care. Armed with in-formation, patients have become active partnerswith health care professionals in managing theirown health care.

Direct to Consumer (DTC) advertising isone of many sources consumers have for infor-mation about diseases and treatments. It alsofosters competition among products, which canlead to improved quality and lower prices forconsumers. Most importantly, DTC advertis-ing can help start a dialogue between patientsand doctors. Often, this dialogue will not resultin the doctor prescribing the drug that the pa-tient has asked about. But it will prompt a dis-cussion that may lead to better understandingand treatment of the patient’s condition.

A study released in May 1998 by Preven-tion magazine found consumers like pharma-ceutical advertising because it “allows people tobe more involved with their health.” Furtherthe study found that such advertising “is an ex-tremely effective means of promoting both thepublic health and prescription medicines” andconcluded that “the benefits of DTC advertis-ing could go far beyond simply selling prescrip-tion medicines: these advertisements may playa very real role in enhancing the public health.”

The research determined that pharmaceu-tical advertising has helped foster patient-phy-sician dialogue where none had previously ex-isted and, more importantly, improved that dia-logue as patients came prepared, armed withinformation from websites, brochures and 800

numbers. In fact, the survey found that DTCadvertising prompted an estimated 21.2 millionAmericans to talk to their doctors about a medi-cal condition or illness they had never discussedwith a physician before. In other words, mil-lions of people who had previously suffered insilence were encouraged to seek help.

A follow-up survey, released in September1999, found that 76 percent of adults think thatDTC advertising helps them be more involvedin their own health care and that 72 percentthink DTC educates people about the risks andbenefits of prescription medicines. In addition,the study found that this type of advertising hasa positive effect on compliance: 31 percent ofthose who had seen an ad for their prescriptionmedicine say they are more likely to take themedicine, and 33 percent say the ad remindedthem to have the prescription filled.

Pharmaceutical advertisements raise aware-ness of conditions and diseases that often goundiagnosed and untreated. Further, such ad-vertising can raise awareness that treatments areavailable to populations that have traditionallybeen undertreated. According to the AmericanDiabetes Association, for example, there areeight million Americans with diabetes who don’tknow they have the disease. One third of thepeople with major depression seek no treatmentand millions of Americans are estimated to havehigh blood pressure and don’t know about it.By informing people about the symptoms ofsuch diseases and that there are effective treat-ments available, DTC advertising can improvepublic well-being.

Consumers are actively seeking informa-tion about their health and about medicines.Pharmaceutical companies are a prime sourceof such information. Patients have the right toask for information about the treatments avail-able, and the companies that develop those treat-

ments have a right to communicate informa-tion about these problems and about treatmentsto patients. ✦

Alan Holmer assumed duties at the Pharma-ceutical Research Manufacturers of America(PhRMA) in July, 1996. PhRMA represents thecountry’s leading research-based pharmaceuticaland biotechnology companies which are invest-ing nearly $24 billion in 1999 alone in the questfor new medicines.

PreferredOne, a leading Minneapolis-based managed care organizationserving the Upper Midwest andoperating HMO, TPA, and PPOproducts, is seeking a Chief MedicalOfficer to lead the development of themedical management and qualitymanagement functions in a consumer-driven environment. Requirements:Board certification with a minimum of fiveyears clinical practice experience, five-plus years progressive managementexperience in a health insurance/managedcare entity, excellent communication,and leadership skills. Compensation:Competitive base salary, bonuspotential, and full benefit package.

��

Please send cover letter and resume to:Nancy Hayes, Human Resources

PreferredOne6105 Golden Hills Drive,Minneapolis, MN 55416

or email: [email protected] Y A L A N F. H O L M E RP r e s i d e n t & C E O , P h R M A


T

Pharmacists Feel the Effects ofDirect to Consumer Advertising

TARGETING THE PATIENT and ultimatelythe consumer of “prescription only” drugs inpromotional campaigns by the pharmaceuticalmanufacturers has been going on for quite sometime. Those of us who were in practice duringthe advent of Motrin® and Clinoril® will re-member the series of manufacturer generatedpress releases prior to product launch. Thesepress releases resulted in a tremendous demandby the consumer for a prescription and this wasreflected in the market values of the corpora-tions. The success of those tactics led, predict-ably, to conventional media promotion of drugproducts. It has been demonstrated that Directto Consumer (DTC) advertising will moveproduct and market share.

It is the belief of the practicing pharmacistthat absent government intervention DTC ad-vertising will continue to grow. Further, we rec-ognize that many of the changes in the attitudesof our society toward drugs will continue to drivethe practice.

When purchasing drug benefits, thenation’s employers have focused totally on drugcost rather than the effective use of drugs. As aresult, the drug product has become anothercommodity that, to many, warrants the samecommercial treatment as any other commodity.

Consumerism over the past 20 years hasresulted in a better informed public whoselifestyle concerns cause them to want to be ac-tive in the management of their own health andhealth related problems.

The results of managed care’s constantsearch for manufacturer rebates in the programsthat drive their formularies, influence prescrib-ing patterns as much, or more, than individualphysician judgements.

It has become increasingly difficult for themanufacturers’ sales forces to access the pre-scriber. This has effectively removed the physi-cian from the position of a decision-maker, whocan be influenced. And, since managed care fo-cuses primarily on the drug price, this leaves theconsumer as the surviving decision-maker thatis subject to marketing influence.

E-Commerce has made many “prescriptiononly” drugs available directly to consumers.These drugs were previously available only byprescription from their physicians.

The practicing pharmacist has three majorareas of concern.

Quality of the advertisement: The over-all result of the ads should be the improvedhealth of the reader. There is a need for morespecificity in the reason for using the product,as well as more detail in the areas ofcontraindications, allergies and potential fordrug interactions. Additionally there is a needfor advising the reader of the formulary statusof the product for the major health plans in theparticular market.

Hassle factor: Once the typical reader ofthese ads has become interested in the product,he or she will ask the pharmacist about the drugthe next time the pharmacy is visited. This putsthe pharmacist in the position of serving as thetriage agent for the use of the drug product.Once the pharmacist has reviewed the patient’sdrug profile and the patient’s recollection of themedical problem, the pharmacist will advise thepatient that the drug is clearly inappropriate, orthat it may be appropriate and it should be dis-cussed with their physician. This pharmacistactivity results in the physician being contactedby only a small percentage of the initially inter-ested consumers — the bulk of the inquirieshaving been handled by the pharmacist.

One of the problems that is vexing for the

pharmacist is that the manufacturers give noprior warning that the product is going to bepromoted. If it is a product that is seldom usedby the prescribers in our area we may not beknowledgeable about the drug. This results inour needing to take the time to study a drug,which because of prescribing patterns has beendemonstrated to have little importance to us. Or,telling the person that we are unable to answerhis or her question. Neither option is acceptable.

Managed care organizations do not alwayscover the product being promoted. In fact, sev-eral MCOs will remove a drug from the formu-lary if it is promoted directly to the consumer.The patients’, pharmacists’ and physicians’ lackof information about the drug’s formulary sta-tus results in a lot of extra work for everyone.

Cost: The pharmacist cannot bill theMCO or the patient for advising the patientthat the drug is inappropriate or referring themto the physician for further consideration.

As a result, these DTC ads contribute tothe cost of managing a pharmacy. The last feeincrease that pharmacists received from man-aged care was in 1988. So, even if a prescriptionultimately results, the reimbursement will be in-sufficient to cover the costs of any professionalservices or managing consumer demand gener-ated by drug manufacturers’ promotional cam-paigns. ✦

The author is a former president of the AmericanPharmaceutical Association, Minnesota Pharma-cists Association, Minnesota Board of Pharmacyand former vice-chairman of Physicians HealthPlan of Minnesota. He practices at Bel-Aire Phar-macy, White Bear Lake, MN.

B Y L O W E L L J . A N D E R S O N ,R . P h . , D . S c .


A

Regulatory Issues withDietary SupplementsIntroductionA THIRTY-YEAR-OLD professional athlete hasa seizure, stops breathing and nearly dies froman unregulated dietary supplement. The 6-foot-10-inch Phoenix Suns forward and formerTimberwolf ingested an herbal supplement con-nected to at least one death, possibly three, andover 100 serious illnesses. Team physician, Dr.Richard Emerson, is quoted as saying “It is be-ing marketed as a safe herbal supplement…It’sa pretty dangerous substance.” In the News Ser-vice article which appeared in the Star & Tri-bune, FDA spokesman, Ruth Welch, said thatas a dietary supplement, “they can go on themarket without us being aware of it.” “I didn’thave any idea something like this could hap-pen. I nearly lost my life,” noted Gugliotta afterthe event and added, “I didn’t think it was any-thing more dangerous than a vitamin.” Thecompound, furanone di-hydro is sold under avariety of brand names.

This is but one example of the many ad-verse reactions that occur from unregulated “di-etary supplements.” For these and many otherreasons, the Minnesota Medical Associationpassed a resolution from the Ramsey MedicalSociety in December 1999, calling on theAmerican Medical Association (AMA) to workwith Congress to pass federal legislation thatimplements regulation of dietary supplementsand herbal remedies by the Food and Drug Ad-ministration (FDA). The resolution carriedwithout dissension and was passed with amend-ments by the AMA. The resolution did not takea position on the possible usefulness or poten-tial harm of these supplements, only that theybe regulated as to content and purity and when

appropriate, that their use beunder the direction of a quali-fied health care professional asis the case in much of Europe.

Many metro and nation-wide physicians were, therefore,disappointed when the FDA“surrendered its responsibilityto protect the public” (Star Tri-bune 1/13/00) which allows la-beling of supplements as to“how a vitamin or herbal com-pound might be used to pro-mote health or relieve condi-tions.”

Dietary supplements aredefined as products “intended to supplementthe diet that contain one or more of the follow-ing dietary ingredients: a vitamin, mineral, herbor other botanical, amino acid, a dietary sub-stance for use by man to supplement the dietby increasing the total daily intake, or a con-centrate, metabolite, constituent, extract, orcombination of these ingredients.” More than40 percent of adult Americans use some formof alternative medicine, spending $5.1 billionout-of-pocket for herbal medicines in 1997.Over 60 percent of patients do not disclose theiruse of alternative medicine to their physician.Often, patients diagnose themselves and treatthemselves with dietary supplements withoutadequate knowledge and understanding aboutthe products.

Consumers may not utilize the best sourcesof information. A 1997 survey found that al-most half of consumers get their informationon herbal products from friends and family, fol-lowed closely by magazines and books. Less than10 percent get their information from physi-cians, and only four percent from pharmacists.If this survey were done today, the Internet

would likely be a major source of information.Partially due to their information sources, con-sumers are often misinformed. A National Con-sumers League survey revealed that almost halfof Americans think that herbs are generallysafe — 37 percent believe they are effective inmaintaining overall health and well-being; 34percent believe they are generally effective; and29 percent think herbs are a good value for themoney. Interestingly, 26 percent wrongly believeherbs have been approved for safety and effec-tiveness by the FDA. A common misconcep-tion is that anything “natural” must be good foryou. What consumers may not know is thatthese dietary supplements do not have to provesafety or efficacy or be approved by the FDAprior to marketing. However, dietary supple-ments often have the same mechanism of ac-tion as pharmaceutical drugs (e.g., saw palmetto,St. John’s wort), and some of these supple-ments are hormones (e.g., melatonin, dehydro-epiandrosterone [DHEA]). Many have been

B Y D O N A L D A S P, M . D . A N DI L A M E H R A H A R R I S , Pharm.D.,BCPS (Continued on page 20)

Donald Asp, M.D. and Ila Mehra Harris, Pharm.D.


shown to be toxic or have serious side effects,but the adverse effects of many are unknown.

RegulationPrior to 1994, dietary supplements were regu-lated as either foods or drugs, depending on theintended use. A substance was considered a food

if its intended use was for taste, aroma or nutri-tive value. For new foods or food additives, safetyhad to be demonstrated prior to marketing. Aproduct was considered a drug if any therapeu-tic claims were made, including structure orfunction claims, or if any other evidence existedthat the intended use was as a drug. All drugswere subject to rigorous safety and efficacy re-quirements for pre-market approval. In 1994,

the Dietary Supplement Health and EducationAct (DSHEA) was passed by Congress, whichcreated a new category for dietary supplements.Under the DSHEA, the supplements now canclaim to affect structure and function. They can-not be intended to treat, prevent, mitigate, cureor diagnose disease. The FDA can only takeaction once a dietary supplement is on the mar-ket and found to be a “significant or unreason-able” risk to consumers. A product can bebanned by the FDA only if it is an “imminenthazard” to consumers. This “innocent untilproven guilty” approach is complicated by theunderreporting of adverse drug reactions.

Good Manufacturing PracticesGood Manufacturing Practices (GMP) are cur-rently required by the FDA for all pharmaceu-ticals and foods. However, dietary supplementshave escaped this regulation from the FDA. TheFDA is considering GMP rules for dietarysupplements, but no such regulations currentlyexist.

Impurities and AdulterantsPartially due to the current lack of GMP, impu-rities and adulterants have been reported in theliterature. When 260 Asian “patent” medicinessold in California retail herbal stores were ana-lyzed, 14 percent were found to contain arsenic,14 percent contained mercury, 10 percent con-tained lead, and 7 percent contained undeclareddrugs such as ephedrine, chlorpheniramine, andmethyltestosterone. A case of hibiscus tea con-taminated with warfarin was reported, whichresulted in an INR of 11.5. An herbal productcalled “Sleeping Buddah” was found to containthe benzodiazepine estazolam. These are just asampling of the numerous similar reports in theliterature. Unless GMP regulations are put intoplace, impurities and adulterants may continueto be found in these products.

StandardizationIn addition to contamination, many reports ofvariability between products have been pub-lished. One cannot be sure that what is writtenon the label is what is in the bottle. In one study,24 ginseng products were analyzed and 33 per-cent contained no active ingredient and 67 per-cent had a large variation in the amount of ac-tive ingredient. Another study showed that when44 feverfew products were analyzed for their


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AccreditationHennepin County Medical Center is accredited by the Minnesota MedicalAssociation (MMA) to sponsor Continuing Medical Education for physicians.

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active ingredient, less than half had an adequateamount. Less than the minimal acceptableamount was present in 32 percent of the prod-ucts, and 22 percent had no detectable activeingredient. Again, these examples are just a sam-pling. Standardization of the active ingredientmay help prevent this problem, which somemanufacturers are using. However, it has notbeen determined if standardization is the idealapproach for all herbal products; many ingredi-ents in a plant may work synergistically.

Product claimsThe FDA is responsible for product labeling,which includes information written on thebottle, on the package, or on a package insert,and materials distributed at the point of sale.Dietary supplements can have labeling claimsof a product affecting the structure or functionof the body (“structure/function” claims), butnot claims that a product can prevent, treat, oraffect disease (“disease” claims). For example, aclaim of “maintains urinary tract health” is al-lowed, while “treats urinary tract infections” isnot. Previously, it was often difficult to tell thedifference between these claims, especially forconsumers. Sometimes, the structure/functionclaims sound better than disease claims! There-fore, the FDA finalized rules for claims ondietary supplements in January 2000. Now,dietary supplements are not allowed to beareither express disease claims (e.g., “treats diabe-tes”) or implied disease claims (e.g., “controlsblood sugar”). Previously, implied disease claimswere allowed. Banning these implied diseaseclaims is a huge step for the FDA. However,under the new ruling, these express and implieddisease claims CAN be made by the name ofthe product (e.g., “Migraine B-Gone”), a state-ment about the product formulation (e.g., “con-tains aspirin”), or through pictures, symbols orvignettes (e.g., EKG tracings, picture of heart).Additionally, claims that are not related to dis-ease are allowed, which include health mainte-nance claims (“maintains a healthy prostate”)and other non-disease claims (“gives you energy,”“enhances muscles”). In addition, common,minor symptoms associated with life stages (e.g.,hot flashes, premenstrual syndrome, mild acne,morning sickness in pregnancy, wrinkles, mildmemory loss associated with aging) are no longerconsidered diseases. Manufacturers can makeclaims about these conditions.

Do claims of effectiveness need to bebacked up with data? Structure/function claimsactually do not require FDA review. Manufac-turers are required to have (in their files) sub-stantiation of any claims they make, but the“substantiation” is not currently reviewed.

When claims are written on product la-bels, a disclaimer must be included that theyare not drugs and receive no FDA pre-marketapproval. Usually included is “This statementhas not been evaluated by the FDA. This prod-uct is not intended to diagnose, treat, cure orprevent any disease.”

AdvertisingThe FDA is not responsible for overseeing ad-vertising for dietary supplements. This fallsunder the Federal Trade Commission (FTC),and includes print ads, broadcast ads,infomercials, catalogs, direct marketing materi-als and the Internet. If any advertising appearsto be false or misleading, or without substan-tiation, complaints can be filed to the FTC bycalling toll free 877-FTC-HELP or by submit-

ting an on-line complaint at www.ftc.gov/ftc/complaint.htm.

The Future of DietarySupplement RegulationThe Center for Food Safety and Applied Nutri-tion (CFSAN) of the FDA recently published adocument entitled Dietary Supplement Strategy:Ten Year Plan, which outlines the strategy toreach their goal to have a “science-based regula-tory program,” which will provide consumerswith a “high level of confidence in the safety,composition, and labeling” of dietary supple-ments. The plan is to fully implement theDSHEA. Steps to reach the program goal areoutlined in detail in the document, and are sum-marized in Table 1 on page 22. This is a greatendeavor by the FDA, and will be monumentalin providing consumers confidence in dietarysupplements. Some issues remain to be unre-solved, such as if dietary supplements should



be required to undergo pharmacokinetic test-ing to identify drug interactions and dosage re-ductions in renal and hepatic dysfunction.Should safety be documented prior to market-ing? Should compounds be evaluated in preg-nancy and lactation? If such measures were inplace, more confidence could be placed in us-ing dietary supplements, and monitoring mightbe done if potential side effects (subjective andobjective) were known. Ideally, dietary supple-ments should be required to pass tests for safetyand effectiveness and meet drug standards forstrength, quality and purity.

I. SAFETYA. Enhance adverse event reportingB. Good Manufacturing Practices (GMP)

1. Publish regulations on GMP and establish an outreach and ongoinginspection program.

C. Health hazard evaluations1. Enhance mechanisms for evaluating health hazards of dietary supple-

ment ingredients and contaminants.D. Dietary supplement safety databaseE. New dietary ingredients

1. Notifications2. Guidance. Develop guidance for safety substantiation for pre-market

notifications for new dietary ingredients.3. Database. Incorporate pre-market (75-day) notifications in the com-

prehensive database created for claims notifications.F. Voluntary submissions. Explore mechanisms for encouraging voluntary

submissions of confidential pre-market safety data to FDA.G. Internet surveillance. Implement an Internet surveillance program to

monitor whether products are marketed for safe uses.

II. LABELINGA. Implement Pearson v. Shalala court decisionB. Response to health claim petitionsC. Database for label claim notificationsD. Substantiation

1. Identify criteria for substantiation of structure/function and relatedclaims and identify conditions for sharing substantiation documents.

E. Publish final rule on claim notifications based on authoritative statementsF. Consumer and marketplace labeling surveysG. Resolve issues about third party publicationsH. Resolve small business exemptions

III. BOUNDARIESA. Publish final rule on structure/function claimsB. Clarify dietary supplement vs. drugC. Clarify dietary supplement vs. conventional foodsD. Develop regulatory framework for botanicalsE. Dietary supplement exclusions

ConclusionUse of dietary supplements is expanding

and is continuing to grow. Currently, little regu-lation by the FDA is in place, which leaves a lotof unknowns with regards to safety, composi-tion, contamination, and efficacy. The ten-yearplan set forth by the FDA’s Center for FoodSafety and Nutrition is an ambitious undertak-ing, and will help solve many of the currentunresolved issues with regard to dietary supple-ments. The future of medicine will likely seeincreasing use of complementary medicine, bothas sole therapy and in conjunction with allo-pathic medicine. If improved regulatory mea-sures are implemented, they will provide con-

sumers and health professionals with more con-fidence in the safety, labeling, and compositionof dietary supplements. ✦

Donald Asp, M.D., is an associate professor, De-partment of Family Practice and Community HealthMedical School, University of Minnesota.

Ila Mehra Harris, Pharm.D., BCPS, is anassistant professor, Department of Pharmaceuti-cal Care and Health Systems, College of Phar-macy, and a clinical assistant professor, Depart-ment of Family Practice and Community HealthMedical School, University of Minnesota.

F. Clarify dual statusG. Clarify regulation of combination productsH. Clarify dietary supplement vs. cosmetic

IV. ENFORCEMENT ACTIVITIESA. Enforcement strategy

1. Safety issues. Take appropriate action against unsafe products.2. Boundary issues. Take appropriate action on products excluded from

being marketed as dietary supplements.3. Labeling and consumer fraud. Take appropriate action on inaccu-

rate and misleading labeling and consumer fraud, including tradecomplaints.

4. Routine compliance. Maintain routine compliance activities, incor-porating enforcement of final rules.

5. Surveillance and monitoring6. Establish partnerships with federal, state and local agencies to en-

hance enforcement.B. Capacity buildingC. Federal Trade Commission (FTC) Coordination. Enhance coordina-

tion with FTC on enforcement cases.

V. SCIENCE BASEA. Strengthen science-base

1. Strengthen research efforts, including agenda, capabilities, leverag-ing, peer-review, and ingredient review.

B. Regulatory oversight and science-based standards for human studiesC. Improve adverse event report monitoring systemD. Claims

1. Distinguish “valid substantiation” for claims (structure/function) from“invalid substantiation” for claims.

E. Explore development inter-agency clearinghouse

VI. OUTREACHA. Establish advisory committeeB. Additional stakeholder outreachC. CommunicationD. Enforcement policies and procedures

Table 1. Dietary Supplement Strategy: Ten Year Plan of theFDA’s Center for Food Safety and Applied Nutrition (CFSAN)



Preparing for Minnesota’sNew Area CodesEffective February 27, 2000, the Minneapolismetropolitan region served by the 612 areacode was split into three different area codes:612, 763 and 952.

The 612 area code was kept by Minne-apolis, Richfield, St. Anthony and the FortSnelling area. Phone numbers for HMS,RMS and MMA executive offices were notaffected and remain 612.The boundary lineseparating the 763 area code from the 952area code approximately follows Interstate394. For the most part, communities locatednorth of I-394 and to the north and north-west of Minneapolis have the new 763 areacode. Communities south of I-394 and to thesouth and southwest of Minneapolis have the952 area code.

Mandatory use of the new area codesand ten-digit dialing for local calls betweenarea codes in the Twin Cities metro area willbegin on January 14, 2001.

Additional information is available at thefollowing web sites: www.mnta.org, or www.uswest.com/areacodes.

“Orientation to Immigrantand Cross-Cultural Health”This spring, Health Advocates offers“Orientation to Immigrant and Cross-Cultural Health.” This course, co-sponsoredby HealthEast, Minnesota InternationalHealth Volunteers and the Center for Cross-Cultural Health, is designed for health careprofessionals and students who anticipateworking in the U.S. with patients and clientswhose country of origin, language, customs,and values may differ from their own.

Participants in the 10-week course areeligible for 20 continuing education contacthours. Classes will be held on Thursdayevenings from 6:30 to 9 p.m. at theHealthEast Midway Health Services Buildingin St. Paul. The series begins on March 16,2000 and runs through May 18.

For more information, contact BarbaraBabbitt, at 612/920-8944. ✦

Celebrating a Centuryof SuccessOn April 7, the Public Health Partnership2000 invites you to attend a celebration ofpublic health accomplishments during the lastcentury. This is an opportunity to supportcollaboration in public health and confirmour commitment to improved health for allMinnesotans. It will be held at Earle BrownHeritage Center in Brooklyn Center. FormerSurgeon General Joycelyn Elders, M.D., is thekeynote speaker. Commissioner of Health JanMalcolm is honorary co-chair of the event.For more information, contact Tricia Todd at651/638-9855.

ERGONOMIC SOLUTIONS:Occupational Therapist provideson-site workstation evaluations forclients experiencing musculoskeletaldisorders to assure proper bodymechanics and workstation design.Benefits are reduced pain, head-aches, and risk of repetitive straininjuries. Techniques used toalleviate migraine headaches inminutes without medication.Contact Patricia Brown, OTR612/971-1372.

PARTNERING OPPORTUNITYFOR FAMILY PRACTICE: BoardCertified Family Physician seekingBoard Certified Family Physician,other Primary Care, OB-GYN, orspecialty physicians, to share officefacility in West Metro area. Practicesite being developed will serve up tosix full-time plus part-time medicalor surgical specialists. If you haveinterest, please contact AlfonsoMorales, M.D., at Southwest FamilyPractice P.A., 612/803-8273. ✦

Classifieds

www.metrodoctors.com—UpdateThe joint web page of the Ramsey andHennepin Medical Societies, metrodoctors.com,has experienced the following:• More than 3,700 physicians are listed.• 648 physicians have enhanced their

listing and completed a mini-web page.• Since January 1, the site has averaged

over 50 user visits per day and over 642hits per day.

• Monday and Tuesday are the busiest daysand over the lunch hour is the busiesttime.

• The vast majority of visits are for thepurpose of using the “find a doctor”function.

• A stepped up advertising campaign isabout to be undertaken and a new lookfor the home page will be installed in earlyMarch.Have you taken the time to complete

your personal mini-web page? If not, the siteuser is not getting all the information thatthey may need to choose your practice.

You can build your own personal mini-webpage by going to www.metrodoctors.com/censusand completing the on-line census sheet.Best Practices for the Care

of AdolescentsA half-day course, “Healthy Transitions: BestPractices for the Care of Adolescents,” willbe held April 14 in the Pillsbury Audito-rium, Hennepin County Medical Center.Providers will learn about tools and resourcesto improve adolescent health practice.

The course includes:• Showcase of Best Practices in Adoles-

cent Health Care;• Overview of AMA Guidelines for

Adolescent Preventive Services (GAPS); and• Ways to Incorporate Youth Assets into

Health Interventions.For more information, contact:

Hennepin County Medical Center, Continu-ing Medical Education, 612/347-2075.

N O T E W O R T H Y

PRESIDENT ’S MESSAGEJ O H N R . G A T E S , M . D .

RMS-Officers

President John R. Gates, M.D.

President-Elect Robert C. Moravec, M.D.

Past President Lyle J. Swenson, M.D.

Secretary Jamie D. Santilli, M.D.

Treasurer Peter H. Kelly, M.D.

RMS-Board Members

Kimberly A. Anderson, M.D.

Charles E. Crutchfield, III, M.D.

Peter J. Daly, M.D.

Thomas B. Dunkel, M.D.

Michael Gonzalez-Campoy, M.D.

James J. Jordan, M.D.

F. Donald Kapps, M.D.

Charlene E. McEvoy, M.D.

Ragnvald Mjanger, M.D.

Joseph L. Rigatuso, M.D.

Thomas F. Rolewicz, M.D.

Paul M. Spilseth, M.D.

Jon V. Thomas, M.D.

Randy S. Twito, M.D.

Russell C. Welch, M.D.

Mark E. Wiest, M.D.

RMS-Ex-Officio Board Members

Blanton Bessinger, M.D., MMA President-ElectRaymond Bonnabeau, M.D., Sr. Physicians

Association PresidentKenneth W. Crabb, M.D., AMA Alternate DelegateStephen P. England, M.D., Community Health

Council ChairMichael Gonzalez-Campoy, M.D., Education

Resource Council ChairDuchess Harris, Alliance Co-PresidentNicki Hyser, Alliance Co-PresidentFrank J. Indihar, M.D., AMA DelegateWilliam Jacott, M.D., U of MN RepresentativeF. Donald Kapps, M.D., Council on

Professionalsim & Ethics ChairMelanie Sullivan, Clinic AdministratorLyle J. Swenson, M.D., Public Policy Council ChairRussell C. Welch, M.D., Communications

Council Chair

RMS-Executive Staff

Roger K. Johnson, CAE, Chief Executive OfficerDoreen Hines, Assistant Director


IIT HAS BEEN MY PRIVILEGE to practicemedicine in St. Paul, Minnesota, for the last 20years. This has been a time of tremendoustechnological advances for the treatment of amultitude of medical conditions. In my spe-cialty alone, our imaging has traversed thespectrum from direct carotid puncture an-giography and pneumoencephalography tofunctional magnetic resonance imaging tomagnetoencephalography and positron emissiontomography scans.

I have had the opportunity to integratethese new technologies into my practice to of-fer true state-of-the-art medical service for mypatients with epilepsy. I have had the privilegeof practicing in a medical community that I havealways felt was second to none in the UnitedStates. The quality of primary care and specialtycare that we have in the Twin Cities, especiallyin the east metro, in my opinion, is extraordi-nary.

Moreover, we have delivered this treatmentin an exemplary, fiscally responsible manner.Uwe Reinhardt, Professor of James MadisonPolitical Economy at Princeton University said:“If everyone practiced medicine like they do inMinnesota, we probably wouldn’t have the fis-cal health care crisis that we currently have.” Infact, he actually doubts that we are part of theUnited States because of this apparent aberrantbehavior.

Despite these extraordinary achievements,both fiscally and qualitatively, I believe we arecurrently teetering on the edge of collapse ofour health care delivery system.

I have had a personal family episode of carethat was far from optimal and quite frankly,frightening. It involved, in my opinion, clearcost-cutting measures that were risky in termsof medication use, or should I say lack of medi-cation use, and inadequate nursing staffing ra-tios for immediate post-operative care. Repeatedrequests to the nurse for over 30 minutes to getassistance for escalating post-operative deterio-ration went simply unmet and not acceptable.Similarly, I have found access to follow-up ap-

pointments, even at my own physician’s office,difficult to obtain. I discovered follow-up ap-pointments not available for three to fourmonths, after 20 minutes on hold.

With the recent flu epidemic, the emer-gency delivery system has been particularlystrained, but even before that explanation wehave had a record number of emergency roomand hospital diverts in the east metro. If a 747went down requiring immediate availability of300 or more hospital beds, we would be in seri-ous difficulty as just finding an extra bed forpneumonia cases right now proves to be a chal-lenge. Anecdotally, I have heard of physician col-leagues retiring early, many primary and spe-cialty groups having difficulties recruiting, anddelayed integration of new life-saving technolo-gies due to fiscal and administrative entangle-ments.

At this time of the best and most sustainedeconomic growth, Harvard Pilgrim Health Planmade the front page of the New York Times be-cause it is in receivership. Locally, retrenchmentsare in process at several metro systems, includ-ing Fairview University and HealthSystemMinnesota.

We’ve tried to handle it ourselves but it isnot working. It is time to recruit the public andbegin to apply some added pressure to HCFA,federal and state legislatures, and insurers. Weneed to state, in no uncertain terms, that thesystem is deteriorating rapidly for regulatory, ad-ministrative and economic reasons. It is mypromise as Ramsey Medical Society presidentto get the word out to the community that wehave a health care delivery system second to nonebut we can’t predict how much longer this willbe true. We need to define quickly what we willdo as a community of patients and health careproviders to insist on the preservation of ourpre-eminence. ✦

It is Time to Act


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Think Globally, Act LocallyHow many times have you heard the statement,“Think globally, act locally?” And, what, exactlydoes it mean?

The “think globally” part gets easier all thetime. We have free trade with Mexico andCanada. Travel to far off places is common. Weeven have Jesse extolling the virtues of Minne-sota to the Japanese.

The “act locally” piece is a little harder toget a handle on. To my mind, it says that ac-tions on behalf of the world are just too enor-mous for us to grasp, let alone do anythingabout. But, if each of us does our own part closeto home, together we can change things.

The Alliance, A FederationLet’s look at this within the context of the Alli-ance. As members of the Federation of theAmerican Medical Association Alliance and theMinnesota Medical Alliance, along with thou-sands of other spouses of physicians through-out the United States, we share a “global” per-spective as we endeavor to promote the healthand well-being of our communities. The legis-lative agenda and ideas for political action areglobal. The strategies to recruit new members,fundraising ideas, a focused voice on health con-cerns and issues — all are the result of globalthinking.

Local ProgramsAs members of the Ramsey Medical SocietyAlliance we’re part of the acting locally efforts.Specifically, the mission of the Alliance is to pro-mote educational and charitable endeavorswhich improve the health and quality of life ofour community. I’d like to touch on a few ofthe ways the Alliance and its members act lo-cally by providing funds and volunteers.

First Steps: A mentoring program for teenmoms, based out of United Hospital. With theconsent of the new mom, volunteers visit herand her baby in the hospital and keep in touchby phone, visits and social gatherings for threeto six months after the birth of the baby. We

also help the moms access other services andsimply offer companionship.

Wigs Without Worry: A service that pro-vides high quality wigs, at no cost, to individu-als suffering hair loss due to medical treatment.

Caring Hearts for the Homeless: A part-nership of the Alliance with Ramsey MedicalSociety and HealthEast to collect hygiene sup-plies and monetary donations for homeless per-sons in St. Paul. Funds have been used for suchservices as purchasing prescription drugs forhomeless women and children.

healthy. They learn about what happens whenthey are admitted to a hospital or have to go toan emergency room, why tests and proceduresare performed and best practices for prevention.The smiles, excited chatter and positive com-ments from teachers and parents in attendancetell us this is a valuable way to “act locally.”

So What?So, you might ask, what’s this got to do withanything? From the esoteric global thinking tothe concrete local action — why do we, as Alli-ance members, do this?

In truth, I can only speak from my ownperspective. However, I’ve shared enough cupsof coffee, time, energy, and effort with Alliancemembers, “globally” and locally, that I have asense of why. Because we care. Because most ofus feel pretty fortunate about our lives and re-gard our Alliance work as an opportunity to giveback. And, simply because we have a life to leadand want to lead it the best way we can. Youknow, it’s so easy to waste our lives, our days,our hours, our minutes. It’s so easy to take thingsfor granted, to exist instead of live. And some-times it’s so hard to go that extra mile as an Al-liance volunteer, but it’s worth it.

Get a LifeThe spouses of physicians that I’ve worked within the Alliance have learned that it’s the journeythat’s important, not the destination; that lifeisn’t a dress rehearsal and that today is the onlyguarantee we’ve got. Alliance members are busypeople with full lives. The job of giving to oth-ers, of helping our communities improve theirhealth and quality of life only makes our livesfuller.

The phrase, “Get a Life,” doesn’t havemeaning in the Alliance. We’ve already gotone! ✦

Sexual Violence Center: A program serv-ing victims and families of sexual violence, rang-ing from sexual harassment to rape. Volunteersand staff offer community education in all gradesof schools and with adult groups centeringaround prevention.

And, there are many other programsthrough which Alliance members serve theircommunity.

Health Fair: Perhaps the largest local un-dertaking to promote health is the annual weeklong Health Fair. Here, hundreds of third gradechildren from St. Paul schools learn about howtheir bodies work and how to keep themselves

Perhapsthe largest local

undertakingto promote health

is the annual week longHealth Fair.

RMS ALLIANCE NEWSE L E A N O R M . G O O D A L L


RMS NEWS

Dr. John Gates Installed as President

DR. JOHN R. GATES, was installed as the129th president of the Ramsey Medical Societyon Thursday, January 27, 2000, at the Univer-sity Club by Dr. Lyle J. Swenson, past presi-dent. Dr. Gates is the president of the Minne-sota Epilepsy Group and he is a board certifiedneurologist. He is also active in the AmericanAcademy of Neurology, Stratis Health, theMMA, the Minnesota Epilepsy League, and theAssociation of Neurologists of Minnesota. Dr.Gates resides in North Oaks with his wife, RitaMeyer, and three children.

Dr. Gates pledged to educate the publicregarding the threats to the health care systemand to work to influence public opinion. Healso advocated for physicians stating that withthe support of patients and the public the threatsto the health care system can be eliminated andpositive change can be made both in the publicpolicy arena and within the health care deliverysystem itself.

The 1999 Ramsey Medical Society Com-munity Service Award was presented to Dr. Neal

Holtan, medical director of the St. Paul-RamseyCounty Department of Health. Dr. Holtan hasan exemplary record of achievements in publichealth. He is a co-founder of the Council forPreventive Medicine. He has a long record ofinvolvement with the Center forPopulation Health and the Cen-ter for Victims of Torture. Heplays a leadership role in theUniversity of Minnesota Schoolof Public Health Alumni Asso-ciation and he has chaired theMMA Committee on PublicHealth and the RMS Council onCommunity Health. He is boardcertified in internal medicine andis completing a Bush Fellowshipin the History of Medicine andPublic Health.

Former Congressman and U.S. SenateCandidate Tim Penny spoke to the large gath-ering of RMS members, spouses, and represen-tatives of other medical organizations. Pennytold the audience, “Today’s Medicare, with its

Dr. Lyle Swenson presents Dr. Neal Holtanwith the Community Service Award. Dr. Lyle Swenson passes the gavel to Dr. John Gates.

Dr. John Gates and his wife, Rita Meyer, with their son, Jason, and daughter, Rachel.

Tim Penny Discusses Medicare Reform at RMS Annual Meeting


In MemoriamHERBERT L. KLEMME, M.D, a retiredpsychiatrist, died January 13 from complica-tions from a stroke. He was 77. He com-pleted medical school at the University ofArkansas. Dr. Klemme practiced generalmedicine in Iowa and Arkansas beforeentering a psychiatry residency at theMenninger School of Psychiatry in Topeka,Kansas in 1960. Upon completion, heremained as senior psychiatrist until 1975.Dr. Klemme came to Minnesota in 1975 andpracticed general psychiatry until he retiredin 1993. ✦

Applicants forMembership

We welcome these new applicants formembership to the Ramsey Medical Society.

ActiveSteven F. Lucas, M.D.University of MinnesotaFamily PracticeHealthPartners (Apple Valley)

Student(from the University of Minnesota)Patrick G. CareyTammy N. ComstockJamison L. HarkerJennifer A. LessardDavid M. Tierney

Transfer into RMS — ResidentDonavan J. Hess, Jr., M.D.University of Minnesota ✦

government dictated, one size fits all benefitplan, doesn’t cut it. To make the program workin the 21st century, we need to trust consumers—Medicare beneficiaries — to use their powerof choice to make the pro-gram more effective and ef-ficient.”

Mr. Penny continued,“If, however, each Medicarebeneficiary could choosefrom a variety of healthplans and benefit packages,and choose the option thatoffered the most desired ser-vices at the best value, thenyou would see health plansengaged in vigorous compe-tition to offer the latest,

most effective treatments and medications at thelowest feasible cost. Such a program could bemodeled after the benefits program offered tofederal employees.” ✦

Tim Penny with Dr. Michael Spence, Sherry Spence, and NormaSommerdorf.

Dr. Robert Moravec presents Dr. Lyle Swenson,outgoing president, with all of the informa-tion on his new kayak.

Dr. Charles and Pat Crutchfield.

Dr. Brett Teten, Lisa Hammerbeck, Dr. Alec Dunkel, Dr. Diane Dahl, Dr. ThomasDunkel, Tim Penny, and Dr. Lyle Swenson.

Reminder…metrodoctors.com

census sheetcan be completed

on-line.www.metrodoctors.com

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Minnesota Medical Business ResourcesCall 612/623-2860

e-mail: [email protected]: mnmed.org/mmbr

Group Purchasing AdvantagesGroup Purchasing provides customers with a

comprehensive purchasing program encompassing

a large variety of services and products that

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Group PurchasingBenefits

The Group Purchasing

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its customers. Other benefits

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negotiation and administration of

supplier contracts, continual expansion of suppliers and services offered,

volume and cost savings reporting for the individual practice, customer

advocacy with suppliers, and dedicated,

professional purchasing management.

GROUP PURCHASING

Call 612/797-0285 x109e-mail: [email protected]

internet: www.triium.com

Brought to you by a partnership of

Minnesota Medical Business Resources and Triium, Inc.

• Office Supplies and Furniture

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Copiers, facsimiles, scanners, and more

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• Employee Recruitment Services

• Individual Insurance Programs

Life, health, long-term care, disability

• Employer-Sponsored Retirement Plans

• Printing Services

Forms, statements, mailing services, and more

• Color-Coded Record Systems

• Promotional Merchandise

• Collection Services

• Cellular Phone Equipment and Air Time

• Auto Leasing and Purchasing Services

• Payor Reimbursement

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• Credit Union Services

• Secured Records Destruction

• Courier Services

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Product and Service Coverage


HMS IN ACTIONJ A C K G . D A V I S , C E O

HMS in Action highlights activities thatyour leadership and executive office staffhave participated in, or responded to,between MetroDoctors issues. We solicityour input on these activities and encour-age your calls regarding issues in which youwould like our involvement.

HMS-Officers

Chair David L. Estrin, M.D.

President Virginia R. Lupo, M.D.

President-Elect David L. Swanson, M.D.

Secretary Richard M. Gebhart, M.D.

Treasurer Michael B. Ainslie, M.D.

Immediate Past Chair Edward A.L. Spenny, M.D.

HMS-Board Members

Michael Belzer, M.D.

Carl E. Burkland, M.D.

Herbert K. Cantrill, M.D.

Penny Chally, Alliance Co-PresidentWilliam Conroy, M.D.

Rebecca Finne, Alliance Co-PresidentJames P. LaRoy, M.D.

Barbara C. LeTourneau, M.D.

Edward C. McElfresh, M.D.

Monica Mykelbust, M.D.

Ronald D. Osborn, D.O.

Joseph F. Rinowski, M.D.

Marc F. Swiontkowski M.D.

T. Michael Tedford, M.D.

D. Clark Tungseth, M.D.

Joan M. Williams, M.D.

Bret Yonke, Medical Student

HMS-Ex-Officio Board Members

E. Duane Engstrom, M.D., Senior Physicians AssociationLee H. Beecher, M.D., MMA-TrusteeKaren K. Dickson, M.D., MMA-TrusteeJohn W. Larsen, M.D., MMA-TrusteeRobert K. Meiches, M.D., MMA-TrusteeHenry T. Smith, M.D., MMA-TrusteeRobert Finke, MMGMA Rep.

HMS-Executive Staff

Jack G. Davis, Chief Executive OfficerNancy K. Bauer, Associate Director

Twenty-five HMS members, board and non-board representatives, participated in a five-hour strategic planning retreat inJanuary. Key activities for future focusincluded membership, member-to-membercollegiality, physician activism, communica-tions, and revisiting the HMS missionstatement and board structure.

Virginia Lupo, M.D. and Lyle Swenson,M.D. presented congratulatory Cross Pens tofirst year medical students on behalf of HMSand RMS at the University of Minnesota’sWhite Coat Ceremony.

The HMS Abuse Prevention Project haschanged its name to the Healthy, Abuse-free Workplace Project. A workshop on“intervention strategies” is being developed.

Planning for the 2000-2001 school yearimmunization requirement notification hasbegun. Fifteen school districts will participatein the No Shots. No School. initiative.HMS is coordinating the mailing to physi-cians and nurse practitioners. Drs. DavidEstrin, Timothy Komoto and Dawn Martinhave again agreed to serve as the physician co-champions of this immunization initiative.

Jack Davis and Nancy Bauer attended theannual meeting of the RamseyMedical Society. John M. Gates, M.D.was installed as their 129th president.

The Adolescent Health Care Coali-tion is co-sponsoring a “best practices”conference with HCMC Department ofPediatrics. Dr. Julia Joseph DiCaprio is theconference chair.

One hundred and thirty medical studentsattended the “Lunch ’n Learn” sessionsponsored by HMS and RMS. Drs. EricBothun (2nd year University of MinnesotaOphthalmology resident) and DwendaGjerdigan, Bethesda University FamilyPractice Clinic, spoke on the “Idealism ofMedicine” and how to keep the fire alive.

Nancy Bauer attended a meeting of theCaring Clinics task force, evaluatingthe west suburban pilot project. The purposeof the pilot is to explore ways to provide medicalcare to the uninsured (St. Mary’s Clinic popula-tion) by “mainstreaming” them into existingprimary care clinics. Look for an article in theMay/June issue of MetroDoctors on this pilot.

Several meetings have taken place betweenHMS, Ramsey Medical Society, MinnesotaMedical Association and MMIC for thepurpose of building a collaborative relation-ship within and between each of the organiza-tions Web strategy. Considerable interestexists for taking the physician directory,developed within “metrodoctors.com,” to astatewide audience.

Several HMS physicians attended an informallunch meeting with Attorney GeneralMike Hatch at his offices. The purpose ofthe meeting was to hear, review, and discussMr. Hatch’s health care priorities.

Jack Davis continues to attend meetings of theMedicare Justice Coalition. Thelawsuit, which challenges HCFA and thegeographic disparity in reimbursement, isprogressing.

Jack Davis has been an invited guest of thebimonthly meetings of the Board of theHennepin Chapter of the Minne-sota Academy of Family Practice.✦

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ARE YOU INTERESTED in serving as a Del-egate to the MMA House of Delegates? TheMMA’s Annual Meeting is scheduled for Sep-tember 13-15, 2000 in Duluth.

HMS will be holding its caucus June 14,7:00 a.m., at which time the Delegates will dis-cuss and vote on resolutions submitted by itsmembers. The resolutions that pass at the Cau-cus will then be forwarded to the MMA Houseof Delegates for consideration.

If you have resolutions that you would liketo have considered at the HMS caucus, pleasesubmit your resolution or ideas by Friday,May 26.

To serve as a Delegate, or for more infor-mation, please contact Kathy Dittmer at 612/623-2885, email: [email protected], or faxat 612/623-2888.✦

Call for Delegatesand Resolutions

HMS NEWS

Family Event at theMinneapolis Institute of Arts

“STAR WARS: The Magic of Myth”

Don’t miss this rare opportunity to discover the creative world of George Lucas and theentire Star Wars saga in this spectacular exhibition. Explore the message of the epicstruggle between good and evil in the films, and discover links between Lucas’ modernclassics and powerful mythological themes from many cultures and times.

FRIDAY, MAY 5, 2000Tours at 6:30 and 7:00 p.m.

Join us for a complimentary ice cream socialfollowing the exhibit tour in the Norwest Room

DISCOUNT TICKETS: $5/person

Deadline for ordering tickets is Monday, April 3, 2000For more information, call Nancy Bauer at 612/623-2893.

Sponsored by: Hennepin Medical Society and Hennepin Medical Society Alliance

HMS Plans for the Future

HMS KICKED OFF the new millennium witha sense of great vigor and accomplishment at astrategic planning retreat held on January 20,2000. Twenty-five members of the Board and afew invited guests gathered for five hours forreview of accomplishments, membership trendsand brainstorming for the future.

A number of challenges were identified,primarily in the areas of declining membershipand unclear value/relevance to the membership,physician apathy, representative Board structure,and scarce resources requiring and limiting col-laboration with other organizations. At the same

time, a number of opportunities were alsobrought forward:• become an attractive organization to all

members;• more interaction with medical students

and residents through mentoring programsand camaraderie;

• “intentional collegiality,” i.e. redefine howto be colleagues and improve doctor-to-doctor communication relating to patientcare; and

• pursue multiple collaborations and com-municate our value to other entities.

In addition, the mission of the HennepinMedical Society was reviewed in context to itsstrategic objectives. It reads, The mission of theHennepin Medical Society is to serve its membersand the community by promoting wellness andidentifying and addressing health care issues in thewest metro area. The group concurred that a re-vision was in order. Members are encouragedto submit their revisions.

The HMS Executive Committee has sincemet and identified the following areas of pri-mary focus for the leadership, committee mem-bers and staff of the Hennepin Medical Soci-ety: revisit the mission statement and represen-tative structure of the Board; promote the valueof membership through enhanced communi-cations and focused membership marketing ef-forts (including professional collegiality); pur-sue physician activism, and multiple collabora-tions.

Both the Membership and Communica-tions Committees have been re-energized andgiven specific tasks to address these areas.

If you are interested in participating ineither of these committees, or any otherHMS activity, please contact Nancy Bauer at612/623-2893 or email: [email protected]. ✦


In MemoriamHAROLD KATKOV, M.D., a pediatriccardiologist, died in January. He was 72. Dr.Katkov founded the Children’s Heart Clinicin Minneapolis in 1970. He was born in St.Paul and graduated from the University ofMinnesota Medical School. He completed hisresidency at the University Hospital inpediatrics, followed by training in pediatriccardiology at the Variety Heart Hospital. Dr.Katkov was a clinical associate professor inpediatrics at the University of Minnesota. Hejoined HMS in 1962.

ALEXANDER LIFSON, M.D., a neurosur-geon who emigrated from Russia 22 yearsago, died from cancer on December 25. Hewas 59. Dr. Lifson worked at the Institute forLow Back and Neck Care in Edina. In 1976he expressed an interest in leaving hishomeland and in 1978 received a fellowshipto work at the Edina center. He became amember of HMS in 1979.

JOSEPH S. MASSEE, M.D., 70, died onJanuary 17. He was an obstetrician/gynecolo-gist for 45 years at the Mayo Clinic, CookCounty Hospital in Chicago and NorthMemorial and Fairview Southdale Hospitals.Dr. Massee founded Obstetrics Gynecology,Infertility, Ltd. and was instrumental inestablishing a women’s health center at NorthMemorial. He graduated from the Universityof Minnesota. He joined HMS in 1964.

JAMES F. SHANDORF, M.D., an obstetri-cian-gynecologist, died in February at the ageof 90. He graduated from the University ofMinnesota Medical School and completed hisinternship and residency at MinneapolisGeneral Hospital. He also completed anOB/Gyn Fellowship at New York Hosptial.Dr. Shandorf joined HMS in 1943.

DAT VAN TRUONG, M.D., died December29 at the age of 61. A family practitioner, heworked in the Twin Cities since 1979. Hegraduated from the Medical University Schoolof Medicine and Pharmacy, Viet Nam. Dr.Truong became a member of HMS in 1984.✦

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Morcon Construction, Inc.5905 Golden Valley RoadGolden Valley, MN 55442

Bill JundtMedical Construction SpecialistMember MMGMA/Gold Sponsor [email protected]

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Phone: 612-546-6066


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HMS ALLIANCE NEWS

FROM THE HENNEPIN MEDICAL SocietyAlliance to all physicians: March 30 is Doctors’Day. We wish to recognize you all — particu-larly on this day — as hard-working physicianscommitted to the health and welfare of patients.We recognize you for all your work for cures,work for ways to help when a cure is not pos-sible, and work with families and friends of thosein crisis. We recognize the many physicians whoare committed to working within the commu-nity, and some internationally, on a volunteerbasis to help those who have healthcare needswhich otherwise could not be met. TheHennepin Medical Society has itself been in-volved in a number of important health relatedcommunity projects: Dakota Healthy Families;Success by 6®; Healthy, Abuse-free Workplaces,No Shots. No School; HealthSpeak; and Ado-lescent Health Care Coalition. We wish to thankyou all!

We also wish the Hennepin Medical Soci-ety a happy 135 years. As co-presidents of theAlliance, Becky Finne and I have the privilegeof sitting on the HMS Board this year and wehave learned a great deal from this experience.Recently the Board met and conducted its an-nual planning event. It was quite efficiently andthoughtfully run. Information was shared as toaccomplishments of the Society, places whereprogress had been less than expected, and a datareview of the board members survey. Then theBoard analyzed the information and developeda list of challenges and opportunities the HMSfaces in 2000. New strategic initiatives were

developed which will work towards achievingHMS long-term strategic objectives, endingwith a discussion on possible next steps. It wasa most positive process and we left with muchfood for thought!

As HMS is 135 years old in 2000, theHennepin Medical Society Alliance is 90 yearsold in 2000 — ninety years in existence sup-porting our physician spouses, ourselves and ourfamilies, and our community by a variety ofways. We have not been a static organization;we have changed the means of support to ad-just for the needs of the times, and will con-tinue to do so. What is important to realize,however, is that the need for the Alliance neverchanges. First, our physician spouses always needour moral support; we always need to be vigi-lant in their cause as the field of healthcare shiftsin its struggle to understand itself and redefineitself. Secondly, there always will be commu-nity health needs that provide avenues for theAlliance to help through education, advocacyand service. Thirdly, there always will be a needfor friendships and the Alliance is a wonderfulplace to find friends — friends from all agesand stages of life: spouses of medical students;spouses of residents; spouses of practicing phy-sicians; and spouses of retired physicians. Eachand every one of us brings something special tothe Alliance. Now is the time to remember thebest, and then use it while continuing to createsomething even more special as we move intothe next century.

BODYWORKS 2000 will be quickly

upon HMSA — this year we will be having theweek-long event from February 28-March 3 inthe Lutheran Brotherhood Auditorium — spacethat Lutheran Brotherhood has donated toHMSA for 13 years. This event is an exampleof keeping the best and making it better. Theprogram was created to give a “hands-on” healthexperience for third grade children that wouldbe fun, informative and useful. Over 100 vol-unteers have staffed BODYWORKS each year,with hundreds of hours of preparation donatedbefore the event. Teacher evaluations indicatethat this event is a terrific educational opportu-nity and resource. Ideally, we wish we could serveall third grade students in the area; however, withlimited time and resources, we offer this on afirst come, first serve sign-up basis. Many class-rooms are turned away each year.

The HMSA initiated another project fouryears ago — the HIV/AIDS Education Folder.Last year this educational tool became a StateAlliance project and in the fall of 1999, thisfolder was given to 160 Middle Schools aroundMinnesota at no expense to the schools. Again,the best was used and the folder was updatedwith phone numbers and added information onHepatitis C. The goal of the folder is to helpyoung students make educated choices so thatthey can develop and maintain healthy, activelives. The HMSA is taking on another programthat will help young people. This project, aimedat helping the teen/high school age person, is tohelp raise funds for the Teen Annex.

It takes time and preparation for a newproject; but research into the needs of a com-munity and how the Alliance can best make animpact is the key to success. For 90 years, HMSAhas understood this and has made a differenceby identifying these needs and then acting tohelp where needed — whether it has been ourspouses, our friends or our community.✦

P E N N Y C H A L L Y

Thank You Doctors

National Doctors’ DayMarch 30

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