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March/April 2000

Doctors MetroDoctors THE JOURNAL OF THE HENNEPIN AND RAMSEY MEDICAL SOCIETIES

Prescription Drug Advertising: Is it a problem for you and your patients?

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Physician Co-editor Thomas B. Dunkel, M.D. Physician Co-editor Richard J. Morris, M.D. Managing Editor Nancy K. Bauer Assistant Editor Doreen Hines HMS CEO Jack G. Davis RMS CEO Roger K. Johnson Production Manager Sheila A. Hatcher Advertising Manager Dustin J. Rossow Cover Design by Susan Reed MetroDoctors (ISSN 1526-4262) is published bimonthly by the Hennepin and Ramsey Medical Societies, 3433 Broadway Street NE, Broadway Place East, Suite 325, Minneapolis, MN 554131761. Periodical postage paid at Minneapolis, Minnesota. Postmaster: Send address changes to MetroDoctors, Hennepin and Ramsey Medical Societies, 3433 Broadway Street NE, Broadway Place East, Suite 325, Minneapolis, MN 554131761. To promote their objectives and services, the Hennepin and Ramsey Medical Societies print information in MetroDoctors regarding activities and interests of the societies. Responsibility is not assumed for opinions expressed or implied in signed articles, and because of the freedom given to contributors, opinions may not necessarily reflect the official position of HMS or RMS. Send letters and other materials for consideration to MetroDoctors, Hennepin and Ramsey Medical Societies, 3433 Broadway Street NE, Broadway Place East, Suite 325, Minneapolis, MN 554131761. E-mail: nbauer@mnmed.org. For advertising rates and space reservations, contact Dustin J. Rossow, 4200 Parklawn Ave., #103, Edina, MN 55435; phone: (612) 8313280; fax: (612) 831-3260; e-mail: djrossow@aol.com. MetroDoctors reserves the right to reject any article or advertising copy not in accordance with editorial policy. Non-members may subscribe to MetroDoctors at a cost of $15 per year or $3 per issue, if extra copies are available.

CONTENTS VOLUME 2, NO. 2

LETTERS

PHYSICIAN’S SOAP BOX

MARCH/APRIL 2000

Kimberly Anderson, M.D.

Overview of Direct to Consumer Advertising

FEATURE: DIRECT TO CONSUMER ADVERTISING

Physicians are Beginning to Experience the Effects

COLLEAGUE INTERVIEW

Richard Simmons, M.D.

Prescription Drug Access, Marketing: Top Issues for Minnesotans

Direct to Consumer Advertising Helps Patients

Pharmacists Feel the Effects of Direct to Consumer Advertising

Regulatory Issues with Dietary Supplements

NOTEWORTHY

CLASSIFIED ADS RAMSEY MEDICAL SOCIETY

24 25 26 27

President’s Message RMS Alliance RMS News Applicants for Membership/In Memoriam HENNEPIN MEDICAL SOCIETY

29 30 31 32

HMS In Action HMS Plans for the Future In Memoriam HMS Alliance

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

MetroDoctors

The Journal of the Hennepin and Ramsey Medical Societies

March/April 2000

LETTERS

After the January/February edition of MetroDoctors went to press, an additional question regarding health plan liability was posed to Lori Swanson. The following is her response. Dear Editor: If the patient and doctor disagree with the HMO’s decision to restrict care, what options exist under the law to adjudicate the dispute before any harm could occur? While many medical claims are paid without a hitch, disputes can arise when health plans refuse to pay for treatment recommended to a patient by his or her treating physician. When this happens, it is important that the patient be aggressive in

protecting his or her legitimate rights to coverage. Unfortunately, these denials often come when the patient is sick and least able to fight back. Accordingly, the doctor can be an important advocate in helping the patient to get the coverage that the patient deserves. Most health plans have an appeal process which can be used by patients whose claims are denied. While the deck is often stacked against the patient (since the decision-maker on the appeal is typically the same company that already denied coverage), appeals can sometimes work. In the event that treatment is needed on an emergency basis, or there is a limited window of opportunity within which the patient must receive treatment, the patient should ask that the health plan treat the appeal on a “rush” basis.

In addition, in 1999 the Minnesota Legislature enacted an external review bill. Under this measure, patients may, effective April 1, 2000, file a request that a denial of care be externally reviewed. The Minnesota Department of Administration will enter into a contract with at least one outside external reviewer to perform such reviews. The results of the external review are binding on the health plan but not on the patient. Because the external review law is not yet effective, it is still unclear precisely how the process will work. Likewise, a patient whose claim has been denied by an HMO may also file a lawsuit to require the health plan to provide coverage. In cases involving access to life-saving medical treatment, the lawsuit may request injunctive relief requiring the health plan to immediately provide coverage. Attorney General Mike Hatch has published a 35-page booklet entitled, Managing Managed Health Care to assist patients in navigating the health care bureaucracy. This free guide is available from the Attorney General’s Office by writing or calling the Office of Minnesota Attorney General Mike Hatch, 1400 NCL Tower, 445 Minnesota Street, St. Paul, MN 55101-2131; ph. 800-657-3787 or (651) 296-3353. ✦ Sincerely, LORI R. SWANSON Deputy Attorney General Office of Minnesota

MetroDoctors welcomes letters to the editor. Send yours to: Nancy K. Bauer, Managing Editor MetroDoctors Hennepin & Ramsey Medical Societies Broadway Place East, Suite 325 3433 Broadway St. NE Minneapolis, MN 55413-1761 Fax: (612) 623-2888 E-mail: nbauer@mnmed.org

March/April 2000

MetroDoctors

The Journal of the Hennepin and Ramsey Medical Societies

MetroDoctors

The Journal of the Hennepin and Ramsey Medical Societies

March/April 2000

MetroDoctors

The Journal of the Hennepin and Ramsey Medical Societies

PHYSICIAN'S SOAP BOX

Whose Patient is it?

AS A PRIMARY CARE PHYSICIAN, I am used to spending extra time and effort to help HMOs save money. My patients must switch medications to reflect HMOs “flavor of the month” formulary or else suffer the penalty of paying extra at the drugstore. These formulary meds are usually determined on a cost basis — that is whatever drug company offers a better deal to the HMOs. So, the HMO changes the formulary, and we, as physicians, get the phone calls from the pharmacists to approve substitutions, then sometimes a phone call from the patient who feels uneasy about changing from their known med to something new to them. When the medication B Y K I M B E R LY A N D E R S O N , M . D .

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The Journal of the Hennepin and Ramsey Medical Societies

alternatives are not acceptable to the patient’s care the physician must explain in writing. Recently I had a very unsettling experience. I received a list of my patients who were to switch brands of “statins” and ace inhibitors compliments of “PCS Clinical Counseling.” I approved the changes when I could, and assumed that the relevant pharmacies would be contacted with the changes. I pictured this as preventing my patients having to wait at the pharmacy while the pharmacist seeks approval. Instead, several days later I got several phone calls from my patients about a “letter” I had sent them. It seems the “clinical consultant” who I had never even met, sent my patients a letter in the first person describing the medication change and signed my name at the bottom! He also took the liberty of telling my patients to call for an appointment to see me in the office in an interval of time that he designated. The aggressiveness is unbelievable! I spoke with him and his manager and got an unimpressive apology and a promise that the consultant would work much closer with me. No thanks! ✦ Kimberly A. Anderson, M.D., is board certified in internal medicine, and is in private practice at Adult Medicine, P.A., in St. Paul.

March/April 2000

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The Journal of the Hennepin and Ramsey Medical Societies

Overview of Direct to Consumer Advertising

THE FACT IS THAT THE DIRECT to Con-

sumer (DTC) advertisements are increasing in frequency and are far from going away anytime in the near future. Whether you feel these ads are right or wrong, they seem to be affecting all aspects of the physician/patient relationship. The trend is obvious by merely watching an evening’s worth of television, or paging through just about any type of magazine. DTC ads are becoming more entertaining and humorous. It has been stated that the successful medication will depend on its marketing team as much as its own capability to treat a disease. There are positive and negative aspects with this trend by the pharmaceutical industry to empower patients with information on new (and in many cases, very expensive) treatments. DTC ads are everywhere these days (magazines, internet, newspapers, and television) and it is affecting both patients and providers in many different facets. In this article we will provide some background on the history of DTC ads and review the marketing trends developing in the pharmaceutical industry. We will also look at the positive and negative effects of this new type of information source for our patients. Between 1983 and 1985, the Food and Drug Administration (FDA) imposed a moratorium on pharmaceutical companies advertising to the patient. The DTC ads after this time period were able to allude to a therapeutic option for treatment of a particular disease state but not allowed to associate a drug name and disease state. Typically, a toll-free number was given for a consumer to obtain further information and they were advised to consult their physician for further information. The first DTC ad on television was for a 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.

MetroDoctors

nicotine patch during the Super Bowl game of 1992. The results were that the demand for the product quickly exceeded the supply — a dream for any company providing a product. Many pharmaceutical companies kept close tabs on the effects of this first ad and then followed the example. Since the FDA lifted its moratorium on DTC advertising for prescription medications in 1985, there has been an increasing emphasis on creating consumer demand for medications by the pharmaceutical industry. In August 1997, the FDA allowed broadcasts to disclose both the name of specific products and the condition which they are intended to treat with the following requirements. • Advertising must not be misleading. • Advertising must contain a major statement disclosing all major risks associated with a particular drug. • Advertising must contain a toll-free number, a reference to a print ad and/or a web address to obtain full product labeling. • Advertising must contain a statement that physicians or pharmacists can provide additional information. Pharmaceutical spending on DTC ads has increased from $20 million in 1989, to over $1.32 billion for 1998. DTC ads are projected to increase over 50 percent in 1999 to $2 billion. This represents a 60 percent annual growth rate since 1989 in DTC ad spending. Pharmaceutical companies still spend 75 percent of the industry’s advertising budget on direct contact with providers and advertising in medical journals. Even though the majority of the budget remains targeted at the provider, it has only increased by 20 percent in 1998. In 1997 and 1998, $3.42 billion and $4.10 billion respectively, were spent in this area of advertising. It is interesting to note that the top ten DTC spending branded medications are using the

The Journal of the Hennepin and Ramsey Medical Societies

Industry Spending (1998) $17 billion — Research and development $8.3 billion — Product promotion $7.0 billion — Health professional education $1.3 billion — DTC promotion majority of their marketing budget to provide information to the consumer rather than the provider. Since the relaxed stance by the FDA on DTC ads, it is clear that the trend is increasing and does not appear to be going away or have any reason to diminish soon. It seems obvious that DTC advertising benefits the pharmaceutical company through improved market share and name recognition, but it is still hard to evaluate the dollar for dollar value of DTC advertising. This information is not readily available at this time. IMS Health (IMS), a group that does have some reporting capabilities in this area, evaluates the impact of DTC investment on branded medications and its effect on market share growth. The key purchasers of this information have been the pharmaceutical companies as part of the effort to evaluate the impact of DTC advertising on market share. The information available in news releases, journals, and surveys of providers and consumers does suggest that it is having an effect on prescription and sales volume. ScheringPlough spent $67-$83 on DTC ads for each new Claritin® prescription generated from the first quarter of 1997 to first quarter of 1998. This added over 450,000 new prescriptions during this time period. Pfizer added 110,000 new Zrytec® prescriptions during this same time period costing the pharmaceutical company $156-$241 for each new prescription. These (Continued on page 8)

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(Continued from page 7)

numbers suggest that money spent on DTC ads does move market share. Another effect of DTC ads is that the new medications released in the market today are being propelled to the “Top 200” list at a much faster rate than ever before. All of these aspects would obviously be considered a benefit for the pharmaceutical company. What are the benefits for the patient? Consumers have had an increasing desire for information to make better choices about their own healthcare. DTC ads are fulfilling this demand by empowering and educating them about health conditions and possible treatments. Prevention Magazine found in a national survey conducted during 1998 that: • More than 53 million patients had a discussion with their physician about a medicine they saw advertised. This is felt to improve public health due to the frequency of under-diagnosed and under-treated disease states. • DTC ads also encouraged a projected 21.2 million patients to discuss a medical condition with their physician that they would not have brought up prior to seeing the DTC ad. • As many as 12.1 million patients received a prescribed medication as a direct result of viewing the DTC ad. • DTC ads may also be associated with improved patient compliance. Seeing their medications advertised on television seems to validate 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 decrease with expanded drug usage. Being able to afford new medications is a concern for most patients — especially the elderly. Recently, Consumer Reports reviewed this issue and concluded that DTC ads are felt not to be in the best interest of the public, but rather meant to move a product. This report also accessed the reliability of DTC ads. They felt that they provided little educational benefit and overall quality was poor. Because of the relatively recent approach to heavily promoting products on television, there has been little research regarding the overall outcomes of DTC marketing. Proponents of DTC advertising point out the following positive impacts: • DTC advertising provides valuable educational information to patients and helps identify and motivate patients with under treated conditions to seek appropriate medical attention. • Informs patients regarding new therapies and options. • Creates a more informed consumer/patient which results in a more collaborative physician-patient relationship. • Improves patient compliance with some forms of therapy. • Provides a general acceptance of some

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

Product

Company

Claritin® Propecia® Zrytec® Zyban® Pravachol® Allegra® Prilosec® Zocor® Evista® Prozac®

Schering-Plough Merck Pfizer Glaxo-Wellcome Bristol Meyer Squibb Hoerchst Marion Roussel Astra Merck Eli Lilly Eli Lilly

March/April 2000

DTC $ (in millions) 185 92 72 64 60 53 50 44 42 41

Professional $ (in millions) 82 19 54 21 50 61 52 46 51 60

MetroDoctors

medical conditions as legitimate for discussion with doctors and reduces the overall negative 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 rather the best advertising campaign. In addition, DTC advertising might have the following negative impacts: • It creates consumer demand at a time of diminishing health plan resources. • Undermines the physician-patient relationship by creating the doctor as the middle man when patients are requesting specific medications that might not be appropriate or on the health plan formulary. • A tendency for DTC advertising to be false and misleading by providing evidence which supports advertising claims and disregarding evidence which does not support claims. • Increasing the potential for adverse drug reactions. Physician response to specific requests by a patient: What is the best way to respond when a patient asks for a specific medication or brings in a print ad for their conditions? A natural, and often wrong, response is to say, “No” or to disregard the patient’s request outright. The potential for an adversarial relationship is increased when the patient feels that they are not listened to and that their specific requests are not adequately addressed in a discussion with their physician. Potentially that patient might seek out alternative care or lose trust in the physician. It is probably best to listen carefully to the patient’s request and establish empathy. If you are not sure about the appropriateness of the medication, keep your options open and hold your opinion for later. Recognize the request from the patient’s perspective. The patient is trying to be an informed consumer and participate in their own health care decisions. Give the patient credit and ask where they heard about the medication. It is also appropriate to ask why the patient prefers the advertised drug. Many patients have done quite a bit of research into their specific condition and are incredibly informed consumers of health care. Feel free to discuss options of treatment that include the price of the drug, indications and side effects, adverse drug reactions and overall efficacy. The Journal of the Hennepin and Ramsey Medical Societies

Try to work with the patient’s knowledge and not against it. Generally, within a 15 minute office visit, a collaboration with the patient takes less time than confrontation. Remember that this is not a challenge of authority but more often a legitimate request to be considered. As a health care professional, it is a good idea to help monitor the ads that you see either in print or on television. Report to the FDA incidences of misleading ads and its effect on patients. Medical professionals must be committed to provide feedback. There is little the FDA has in the way of evidence regarding the harms or benefits of DTC advertising. Physicians must be committed to providing feedback regarding the fair and balanced discussion of drug use and the adequacy of explanations regarding warnings, adverse drug reactions and precautions as well as the overall compliance with the FDA rules. The FDA is currently looking at ways to tighten up the regulations and require companies to design ads that help promote the physician-patient relationship. Pharmaceutical companies should be asked to include physicians in the rolling out of an ad campaign. This could occur by a letter to physicians about ads prior to a specific ad release. This would help the doctor become more informed and to anticipate specific questions that might come up during clinical visits. Finally, recognize that “participatory health care” is changing the nature of the physicianpatient relationship. The ideal physician-patient relationship is based on a mutual partnership. Consumers and patients are seeking increased information from a variety of sources including the internet, libraries and resource centers and DTC advertising. This mutual partnership should be utilized by the physician for better patient compliance, hopefully resulting in improved patient outcomes. ✦

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March/April 2000

FEATURE STORY

Pharmaceutical Companies are Advertising Prescription Drugs

Directly to Consumers and Physicians are Beginning to Experience the Effects

“I often end up explaining the difference between the hype and the actual benefit — or downside — of a drug.” Anthony Woolley, M.D.

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 your patients.

A LAZY AFTERNOON OF WATCHING TELEVISION once meant bumping into medical ads promising relief from minor aches and pains. A middle-aged man in pajamas might stare blankly into the camera and say, “I can’t believe I ate the whole thing.” Whether one actually 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 Direct to Consumer (DTC) ads have proliferated, filling magazines, newspapers, radio, and television 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 a new crop of ads that often take on life’s big problems: anxiety disorders, weight loss, and migraines. In one such commercial, a female cartoon character tells viewers, “I feel anxious. I can’t concentrate.” as the words float across the screen. Soon, a voice is proclaiming the wonders of Buspar®, an anti-anxiety drug, and the woman’s words, and worries, are literally 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 visit debunking 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 by advertising to see a physician for an as-yet-untreated ailment. A small percentage, about seven percent, asked for a specific drug after being prompted by an ad. The rising number of patient requests for specific drugs has several implications, say practicing physicians and other health care professionals. Pharmaceutical companies tend to 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.

BY TODD MELBY

March/April 2000

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The Journal of the Hennepin and Ramsey Medical Societies

That doesn’t stop patients from making requests. A man visiting a resident at Bethesda Clinic 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 a commercial,” 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 Minnesota. “Providing information to consumers is a good thing, but Direct to Consumer advertising 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 drug features photos of the actor who portrayed Newman, the zany postal worker on the hit show “Seinfeld” in fake police mug shots. Harris doesn’t always get the chance to steer residents in what she thinks is the right direction. A prescription for a widely-promoted, but expensive drug, occasionally makes its way to the pharmacy before she can intervene. According to Harris, “Sometimes it’s done 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, heavilypromoted drug, Dr. Jamie Peters said, “I haven’t just heard about it. I’ve done it… I’m not saying it’s something I’m proud of.” Peters, a professor at the University of Minnesota who practices at Smiley’s Clinic in south Minneapolis, is opposed to DTC pharmaceutical advertising. “Pharmaceutical companies are creating a demand for more expensive drugs through advertising. That’s what advertising does: create demand,” Peters says. “If money goes to expensive drugs, there’s not money left for other things.” Many of the new drugs aren’t just slightly more expensive, either. Celebrex® and Zioxx®, both new arthritis fighters, each cost patients about $68 for a one-month prescription. The generic Ibuprofen produces similar results at about one-fourth the cost. Patients, however, are often isolated from costs associated with higher-priced drugs because 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 Arden Hills-based company, now face a 25 percent co-pay on prescription drugs, with a maxi-

“Providing information to consumers is a good thing, but Direct to Consumer advertising is not a good thing.” Ila Harris, Pharm.D.

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March/April 2000

(Continued from page 11)

mum $20 hit. The new policy, which took effect Jan. 1 for employees in the Choice Plus plan, is an attempt to stem rising drug costs, says Terry Koves, director of compensation and benefits. Prescription drug spending at Land O’ Lakes comprised 24 percent of employee medical expenses in 1999. That’s a far cry from the five to seven percent doled out in 1991. Koves believes DTC advertising has contributed to those rising costs. “I’m concerned that there’s pressure on doctors to do something they normally wouldn’t do,” Koves says. “It’s changed the whole dynamic of medical practice as we see it.” Professional organizations have jumped into the fray. Both the American Medical Association (AMA) and the American Association of Family Physicians have promised to study the reasons behind rising drug expenditures, with the AMA focusing on the specific 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 downtown Minneapolis. “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 patients sleepy. Although it’s far more expensive than its competitors, Terzian prefers it. “Should people with colds be knocked out?” Terzian asks. “I’d rather prescribe a little more expensive medication and keep them working and more productive… Too often people look at the cost and not the quality of the drug.” Terzian also favors Zithromax® for many people in need of an antibiotic. Although its cost is higher, it doesn’t need to be taken as frequently as other medications. “What do you think my compliance is going to be?” Terzian asks rhetorically. Not surprisingly, Alan F. Holmer, Pharmaceutical Research and Manufacturers of America president, supports DTC. “Pharmaceutical companies have both a right and a responsibility to inform people about their products under the supervision of the FDA, which regulates prescription drug advertising,” Holmer wrote in the Journal of the American Medical Association (JAMA) last year. “While such advertising prompts more people to seek professional help, it does not dictate the outcome of the physician

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visit or the kind of help patients eventually receive.” A 1998 study in Prevention magazine found that DTC advertising “encouraged a projected 21.2 million consumers to talk with their doctor about a medical condition or illness they had never talked with their doctor about before seeing the advertising.” What if a doctor turns down a patient request for a particular drug? Another survey, this one of randomly selected residents of Sacramento, Calif., asked respondents what steps they would take if 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 those seeking a quick fix for obesity. After seeing ads for Orlistat® or Xenical®, some patients seem reluctant to give up hope in the wonder drugs they’ve seen advertised. Even after being told about unpleasant side effects like fecal incontinence. “Weight loss medication is the exception,” says Dr. Woolley. “These people are very interested, almost insistent (that they be prescribed the drug), despite what you tell them.” Despite the pros and cons of DTC, one can be certain that it is here to stay. Patients are taking their health and this new level of information seriously. They will continue to challenge their pro-

MetroDoctors

The Journal of the Hennepin and Ramsey Medical Societies

viders about their diagnosis and treatment plan armed with advertisements and research. ✦ Todd Melby is a freelance writer.

National Organizations Take Action to Study Pharmaceutical Costs The American Medical Association and the American Association of Family Physicians both recently adopted resolutions that will study the skyrocketing costs of pharmaceuticals. The AMA study will address: the international differences in prices paid for identical drugs; the introduction of new pharmaceuticals that are significantly more expensive than the ones they replace; direct to consumer advertising; lifestyle drugs such as Viagra®, Propecia®, etc.; and the bioavailability, equivalency and efficacy of generic drugs.

March/April 2000

COLLEAGUE INTERVIEW

Richard Simmons, M.D.

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

Q A

What effect has Direct to Consumer (DTC) marketing by pharmaceutical manufacturers had on Medica? It is our opinion that DTC advertising has had a marked effect in increasing 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 pharmaceuticals contributed to the overall increase in health care costs? The percent increase of total health care costs for Medica was 20 percent in 1999 over 1998. The pharmaceutical portion of this increase was 16.1 percent.

The FDA approval process is much quicker than it was just a few years ago, resulting in up to 190+ new compounds a year being approved. How does a health plan manage the process of evaluating this many new drugs each year? In 1999, the FDA approved 83 new drugs. Of these, 35 were new chemicals and five were new biologic compounds. Our Pharmacy and Therapeutics Committee reviews each new approval.

In addition to the existing drug formularies and education programs, will Medica be attempting to introduce new programs to control pharmaceutical costs? Medica is establishing many programs attempting to control the escalation of drug costs, some of which are individual and clinic profiles, clinic educational programs led by Medica’s in house Pharm.D. Margaret Schmidt, articles in Connections, articles in member newsletters, specific contracts with manufacturers, etc. 14

March/April 2000

Has Medica considered a patient education program to counter the direct consumer advertising of the pharmaceutical companies? We anticipate that during the next year or two, Medica will include pharmacy-related articles in every member newsletter.

Assuming that in the physician’s judgement the patient’s situation requires going off formulary. What procedure should the physician use to get the necessary approval? Approximately 75 percent of Medica members who have pharmacy benefits within their contracts have a second tier option. This allows members to obtain nonformulary drugs for an increased co-pay.

There recently was a mailing to Medica patients inviting them to ask their physician about changing their prescription to Lipitor. Why is this type of mailing being sent to patients and not their physicians? This is an example of Medica’s attempt to educate members to the availability of a potentially superior drug and at the same time a lower cost drug to Medica. This is truly a win/win situation.

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The Journal of the Hennepin and Ramsey Medical Societies

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

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

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

Speaking personally, I am apprehensive about any more government controls in the area of health care. That being said, organized medicine in conjunction with managed care has the potential to dramatically slow the pharmaceutical cost trend.

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

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

Medica has obtained physician specific prescribing profiles for some physicians in a pilot project. This information was only used for educational purposes. Medica obtains this information from its PBM and Medica does not transfer it to any third party.

Medica, as part of the managed care community, is very concerned with the escalation of drug costs. Although it has not yet happened here, in some areas of our country prescription costs are larger than in-patient care. For example, in some plans, 23+ percent of the health care cost “pie” are prescription costs; while at Medica, at present, prescription costs are 19 percent of the total.

How does Medica plan to publicize its formulary? Medica has just completed distributing its year 2000 formulary. If you did not receive it, please call 1-800-458-5512 or (612) 992-2232. In addition, the Council of Health Plans has distributed a compilation formulary every six months for the past three years. The current formulary can be obtained from Medica’s web site at www.medica.com.

MetroDoctors

The Journal of the Hennepin and Ramsey Medical Societies

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

March/April 2000

Prescription Drug Access, Marketing: Top Issues for Minnesotans

PRESCRIPTION DRUGS are increasingly be-

coming one of the most hotly contested issues on Capitol Hill. Seniors’ groups are calling for a prescription drug benefit under Medicare, members of Congress are sorting through a vast array of reform proposals, and drug companies are working to maintain their profit margins. If nothing else, the millions of dollars that the pharmaceutical companies spend on lobbying efforts and advertising indicate just how significant this issue is, and just how much is at stake. Although change is often slow to come in Washington, it appears that the time for real reform on the prescription drug issue is edging nearer. My work on prescription drugs has attracted the attention of more people than just the seniors in Minnesota. Citizens for Better Medicare, a group primarily funded by the Pharmaceutical Research Manufacturers of America (PhRMA), launched a multi-million dollar attack campaign aimed at my work to make medicine more affordable for seniors. The deceptive ads (conducted through a front group) misrepresented my efforts to make medicine affordable for the seniors who need it. The simple fact that the pharmaceutical industry was willing to pour millions of dollars into a deceptive attack against me calls into question the industry’s credibility on this issue. And clearly, consumers have the most to lose if nothing is done to change the way we handle prescription drugs. The Direct to Consumer (DTC) marketing of prescription medication is yet another emerging issue relating to cost and appropriate care. DTC advertising has proven to be extremely successful in efforts by manufacturers to essentially “override the middleman,” the physician, and convince patients that they need

BY BILL LUTHER Congressman, Minnesota 6th District

March/April 2000

one particular drug even if a trained health professional believes some other drug would be equally or more effective, oftentimes at a lower cost. Drug companies spent more than a billion dollars on television, print, and radio advertisements in 1999 alone. This type of marketing is very controversial, and for good reason. The aggressive marketing of pharmaceuticals is costly, and it is ultimately the consumer who ends up footing the bill through higher-

Worse yet, the net effect of DTC marketing is oftentimes to create unnecessary friction between a patient and his or her doctor over appropriate treatment. priced medication. Moreover, while it is important to give consumers choices in their health care decisions, in order to make sound choices they need accurate and dependable information. Unfortunately, the FDA does not require that the product labeling be written in language that most consumers can understand. In fact, most of the information accompanying prescription drugs is written for healthcare professionals. The average consumer does not have the time or the MetroDoctors

training to understand this complex technical medical information. Research also has demonstrated that DTC ads often steer individuals away from generics or older, more reliable medication and toward the latest, and usually more expensive, brand-name drugs. This drives up the cost of medication even higher, and does not necessarily provide better treatment of a health condition. Worse yet, the net effect of DTC marketing is oftentimes to create unnecessary friction between a patient and his or her doctor over appropriate treatment. Madison Avenue advertising should not replace or undermine the critically important doctor-patient relationship. It is not likely that pharmaceutical companies will end all direct marketing to consumers. Change, however, is essential to ensure that consumers have access to information that is accurate and fully discloses the risks and efficacy of advertised drugs, as well as information about other medication or treatments that could work just as well. I recognize that this is a very serious issue, and that it may need to be addressed legislatively. It is my hope that Congress will act to protect consumers so that they are able to make, and have access to, the best possible health care choices. As we begin to seriously review this issue in Congress, I believe as a first priority we must ensure that the patients’ interests are being served. With the help of concerned consumers and health professionals, I am dedicated to helping make this happen. ✦ The Journal of the Hennepin and Ramsey Medical Societies

Direct to Consumer Advertising Helps Patients

MORE THAN EVER, patients are taking con-

trol of their own health destinies. The consumer movement and the information explosion have empowered patients to participate in decisions concerning their health care. Armed with information, patients have become active partners with health care professionals in managing their own health care. Direct to Consumer (DTC) advertising is one of many sources consumers have for information about diseases and treatments. It also fosters competition among products, which can lead to improved quality and lower prices for consumers. Most importantly, DTC advertising can help start a dialogue between patients and doctors. Often, this dialogue will not result in the doctor prescribing the drug that the patient has asked about. But it will prompt a discussion that may lead to better understanding and treatment of the patient’s condition. A study released in May 1998 by Prevention magazine found consumers like pharmaceutical advertising because it “allows people to be more involved with their health.” Further the study found that such advertising “is an extremely effective means of promoting both the public health and prescription medicines” and concluded that “the benefits of DTC advertising could go far beyond simply selling prescription medicines: these advertisements may play a very real role in enhancing the public health.” The research determined that pharmaceutical advertising has helped foster patient-physician dialogue where none had previously existed and, more importantly, improved that dialogue as patients came prepared, armed with information from websites, brochures and 800

B Y A L A N F. H O L M E R President & CEO, PhRMA

MetroDoctors

numbers. In fact, the survey found that DTC advertising prompted an estimated 21.2 million Americans to talk to their doctors about a medical condition or illness they had never discussed with a physician before. In other words, millions of people who had previously suffered in silence were encouraged to seek help. A follow-up survey, released in September 1999, found that 76 percent of adults think that DTC advertising helps them be more involved in their own health care and that 72 percent think DTC educates people about the risks and benefits of prescription medicines. In addition, the study found that this type of advertising has a positive effect on compliance: 31 percent of those who had seen an ad for their prescription medicine say they are more likely to take the medicine, and 33 percent say the ad reminded them to have the prescription filled. Pharmaceutical advertisements raise awareness of conditions and diseases that often go undiagnosed and untreated. Further, such advertising can raise awareness that treatments are available to populations that have traditionally been undertreated. According to the American Diabetes Association, for example, there are eight million Americans with diabetes who don’t know they have the disease. One third of the people with major depression seek no treatment and millions of Americans are estimated to have high blood pressure and don’t know about it. By informing people about the symptoms of such diseases and that there are effective treatments available, DTC advertising can improve public well-being. Consumers are actively seeking information about their health and about medicines. Pharmaceutical companies are a prime source of such information. Patients have the right to ask for information about the treatments available, and the companies that develop those treat-

The Journal of the Hennepin and Ramsey Medical Societies

ments have a right to communicate information about these problems and about treatments to patients. ✦

Alan Holmer assumed duties at the Pharmaceutical Research Manufacturers of America (PhRMA) in July, 1996. PhRMA represents the country’s leading research-based pharmaceutical and biotechnology companies which are investing nearly $24 billion in 1999 alone in the quest for new medicines.

Chief Medical Officer PreferredOne, a leading Minneapolisbased managed care organization serving the Upper Midwest and operating HMO, TPA, and PPO products, is seeking a Chief Medical Officer to lead the development of the medical management and quality management functions in a consumerdriven environment. Requirements: Board certification with a minimum of five years clinical practice experience, fiveplus years progressive management experience in a health insurance/managed care entity, excellent communication, and leadership skills. Compensation: Competitive base salary, bonus potential, and full benefit package. Please send cover letter and resume to:

Nancy Hayes, Human Resources PreferredOne 6105 Golden Hills Drive, Minneapolis, MN 55416 or email: nhayes@preferredone.com

March/April 2000

Pharmacists Feel the Effects of Direct to Consumer Advertising

TARGETING THE PATIENT and ultimately

the consumer of “prescription only” drugs in promotional campaigns by the pharmaceutical manufacturers has been going on for quite some time. Those of us who were in practice during the advent of Motrin® and Clinoril® will remember the series of manufacturer generated press releases prior to product launch. These press releases resulted in a tremendous demand by the consumer for a prescription and this was reflected in the market values of the corporations. The success of those tactics led, predictably, to conventional media promotion of drug products. It has been demonstrated that Direct to Consumer (DTC) advertising will move product and market share. It is the belief of the practicing pharmacist that absent government intervention DTC advertising will continue to grow. Further, we recognize that many of the changes in the attitudes of our society toward drugs will continue to drive the practice. When purchasing drug benefits, the nation’s employers have focused totally on drug cost rather than the effective use of drugs. As a result, the drug product has become another commodity that, to many, warrants the same commercial treatment as any other commodity. Consumerism over the past 20 years has resulted in a better informed public whose lifestyle concerns cause them to want to be active in the management of their own health and health related problems. The results of managed care’s constant search for manufacturer rebates in the programs that drive their formularies, influence prescribing patterns as much, or more, than individual physician judgements.

BY LOWELL J. ANDERSON, R.Ph., D.Sc.

March/April 2000

It has become increasingly difficult for the manufacturers’ sales forces to access the prescriber. This has effectively removed the physician from the position of a decision-maker, who can be influenced. And, since managed care focuses primarily on the drug price, this leaves the consumer as the surviving decision-maker that is subject to marketing influence. E-Commerce has made many “prescription only” drugs available directly to consumers. These drugs were previously available only by prescription from their physicians. The practicing pharmacist has three major areas of concern. Quality of the advertisement: The overall result of the ads should be the improved health of the reader. There is a need for more specificity in the reason for using the product, as well as more detail in the areas of contraindications, allergies and potential for drug interactions. Additionally there is a need for advising the reader of the formulary status of the product for the major health plans in the particular market. Hassle factor: Once the typical reader of these ads has become interested in the product, he or she will ask the pharmacist about the drug the next time the pharmacy is visited. This puts the pharmacist in the position of serving as the triage agent for the use of the drug product. Once the pharmacist has reviewed the patient’s drug profile and the patient’s recollection of the medical problem, the pharmacist will advise the patient that the drug is clearly inappropriate, or that it may be appropriate and it should be discussed with their physician. This pharmacist activity results in the physician being contacted by only a small percentage of the initially interested consumers — the bulk of the inquiries having been handled by the pharmacist. One of the problems that is vexing for the MetroDoctors

pharmacist is that the manufacturers give no prior warning that the product is going to be promoted. If it is a product that is seldom used by the prescribers in our area we may not be knowledgeable about the drug. This results in our needing to take the time to study a drug, which because of prescribing patterns has been demonstrated to have little importance to us. Or, telling the person that we are unable to answer his or her question. Neither option is acceptable. Managed care organizations do not always cover the product being promoted. In fact, several MCOs will remove a drug from the formulary if it is promoted directly to the consumer. The patients’, pharmacists’ and physicians’ lack of information about the drug’s formulary status results in a lot of extra work for everyone. Cost: The pharmacist cannot bill the MCO or the patient for advising the patient that the drug is inappropriate or referring them to the physician for further consideration. As a result, these DTC ads contribute to the cost of managing a pharmacy. The last fee increase that pharmacists received from managed care was in 1988. So, even if a prescription ultimately results, the reimbursement will be insufficient to cover the costs of any professional services or managing consumer demand generated by drug manufacturers’ promotional campaigns. ✦ The author is a former president of the American Pharmaceutical Association, Minnesota Pharmacists Association, Minnesota Board of Pharmacy and former vice-chairman of Physicians Health Plan of Minnesota. He practices at Bel-Aire Pharmacy, White Bear Lake, MN. The Journal of the Hennepin and Ramsey Medical Societies

Regulatory Issues with Dietary Supplements

Introduction A THIRTY-YEAR-OLD professional athlete has a seizure, stops breathing and nearly dies from an unregulated dietary supplement. The 6-foot10-inch Phoenix Suns forward and former Timberwolf ingested an herbal supplement connected to at least one death, possibly three, and over 100 serious illnesses. Team physician, Dr. Richard Emerson, is quoted as saying “It is being marketed as a safe herbal supplement…It’s a pretty dangerous substance.” In the News Service article which appeared in the Star & Tribune, FDA spokesman, Ruth Welch, said that as a dietary supplement, “they can go on the market without us being aware of it.” “I didn’t have any idea something like this could happen. I nearly lost my life,” noted Gugliotta after the event and added, “I didn’t think it was anything more dangerous than a vitamin.” The compound, furanone di-hydro is sold under a variety of brand names. This is but one example of the many adverse reactions that occur from unregulated “dietary supplements.” For these and many other reasons, the Minnesota Medical Association passed a resolution from the Ramsey Medical Society in December 1999, calling on the American Medical Association (AMA) to work with Congress to pass federal legislation that implements regulation of dietary supplements and herbal remedies by the Food and Drug Administration (FDA). The resolution carried without dissension and was passed with amendments by the AMA. The resolution did not take a position on the possible usefulness or potential harm of these supplements, only that they be regulated as to content and purity and when

B Y D O N A L D A S P, M . D . A N D I L A M E H R A H A R R I S , Pharm.D., BCPS

MetroDoctors

appropriate, that their use be under the direction of a qualified health care professional as is the case in much of Europe. Many metro and nationwide physicians were, therefore, disappointed when the FDA “surrendered its responsibility to protect the public” (Star Tribune 1/13/00) which allows labeling of supplements as to “how a vitamin or herbal compound might be used to promote health or relieve condiDonald Asp, M.D. and Ila Mehra Harris, Pharm.D. tions.” Dietary supplements are defined as products “intended to supplement the diet that contain one or more of the followwould likely be a major source of information. ing dietary ingredients: a vitamin, mineral, herb Partially due to their information sources, conor other botanical, amino acid, a dietary subsumers are often misinformed. A National Constance for use by man to supplement the diet sumers League survey revealed that almost half by increasing the total daily intake, or a conof Americans think that herbs are generally centrate, metabolite, constituent, extract, or safe — 37 percent believe they are effective in combination of these ingredients.” More than maintaining overall health and well-being; 34 40 percent of adult Americans use some form percent believe they are generally effective; and of alternative medicine, spending $5.1 billion 29 percent think herbs are a good value for the out-of-pocket for herbal medicines in 1997. money. Interestingly, 26 percent wrongly believe Over 60 percent of patients do not disclose their herbs have been approved for safety and effecuse of alternative medicine to their physician. tiveness by the FDA. A common misconcepOften, patients diagnose themselves and treat tion is that anything “natural” must be good for themselves with dietary supplements without you. What consumers may not know is that adequate knowledge and understanding about these dietary supplements do not have to prove the products. safety or efficacy or be approved by the FDA Consumers may not utilize the best sources prior to marketing. However, dietary suppleof information. A 1997 survey found that alments often have the same mechanism of acmost half of consumers get their information tion as pharmaceutical drugs (e.g., saw palmetto, on herbal products from friends and family, folSt. John’s wort), and some of these supplelowed closely by magazines and books. Less than ments are hormones (e.g., melatonin, dehydro10 percent get their information from physiepiandrosterone [DHEA]). Many have been cians, and only four percent from pharmacists. If this survey were done today, the Internet (Continued on page 20)

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March/April 2000

(Continued from page 19)

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

CME @ HCMC

Regulation Prior to 1994, dietary supplements were regulated as either foods or drugs, depending on the intended use. A substance was considered a food

if its intended use was for taste, aroma or nutritive value. For new foods or food additives, safety had to be demonstrated prior to marketing. A product was considered a drug if any therapeutic claims were made, including structure or function claims, or if any other evidence existed that the intended use was as a drug. All drugs were subject to rigorous safety and efficacy requirements for pre-market approval. In 1994,

Hennepin County Medical Center (HCMC) is one of the major teaching hospitals in Minnesota. Continuing Medical Education (CME), formerly known as the Office of Academic Affairs, was established at HCMC in 1983. The mission of HCMC's CME Program is: "to provide organized, planned education activities to help physicians improve delivery of medical care." Accreditation Hennepin County Medical Center is accredited by the Minnesota Medical Association (MMA) to sponsor Continuing Medical Education for physicians. Hennepin County Medical Center designates hour-per-hour credit hours in category 1 of the Physician's Recognition Award of the American Medical Association. EMS Certification Courses Emergency Medical Services offers numerous courses throughout the year. To request a listing of classes or a course brochure, please call 612-347-5681. Visit the EMS Website at www.HCMC.org/DEPTS/EM/EMSED One-Day Conference

Half-Day Conference

Cardiac Auscultation:

Healthy Transitions:

Back to the Basics

April 7, 2000 Hennepin County Medical Center Pillsbury Auditorium Minneapolis, Minn.

Sponsored by: Hennepin County Medical Center Department of Internal Medicine

Best Practices for the Care of Adolescents

April 14, 2000 Pillsbury Auditorium Hennepin County Medical Center Minneapolis, Minn. Sponsored by: Hennepin County Medical Center Department of Pediatrics Adolescent Program

2000

April 14 Healthy Transitions: Best Practices for the Care of Adolescents May 19 Biological, Chemical & Nuclear Terrorism

Standardization In addition to contamination, many reports of variability between products have been published. One cannot be sure that what is written on the label is what is in the bottle. In one study, 24 ginseng products were analyzed and 33 percent contained no active ingredient and 67 percent had a large variation in the amount of active ingredient. Another study showed that when 44 feverfew products were analyzed for their

For More Information We would like to hear your comments and suggestions for CME activities! Hennepin County Medical Center Continuing Medical Education 701 Park Avenue, Mail Code 861-B Minneapolis, Minnesota 55415-1829 612-347-2075 Fax: 612-904-4210 Toll Free: 888-263-4262 email robin.hoppenrath@co.hennepin.mn.us

March/April 2000

Good Manufacturing Practices Good Manufacturing Practices (GMP) are currently required by the FDA for all pharmaceuticals and foods. However, dietary supplements have escaped this regulation from the FDA. The FDA is considering GMP rules for dietary supplements, but no such regulations currently exist. Impurities and Adulterants Partially due to the current lack of GMP, impurities and adulterants have been reported in the literature. When 260 Asian “patent” medicines sold in California retail herbal stores were analyzed, 14 percent were found to contain arsenic, 14 percent contained mercury, 10 percent contained lead, and 7 percent contained undeclared drugs such as ephedrine, chlorpheniramine, and methyltestosterone. A case of hibiscus tea contaminated with warfarin was reported, which resulted in an INR of 11.5. An herbal product called “Sleeping Buddah” was found to contain the benzodiazepine estazolam. These are just a sampling of the numerous similar reports in the literature. Unless GMP regulations are put into place, impurities and adulterants may continue to be found in these products.

SPRING CONFERENCES: April 7 Cardiac Auscultation: Back to the Basics

the Dietary Supplement Health and Education Act (DSHEA) was passed by Congress, which created a new category for dietary supplements. Under the DSHEA, the supplements now can claim to affect structure and function. They cannot be intended to treat, prevent, mitigate, cure or diagnose disease. The FDA can only take action once a dietary supplement is on the market and found to be a “significant or unreasonable” risk to consumers. A product can be banned by the FDA only if it is an “imminent hazard” to consumers. This “innocent until proven guilty” approach is complicated by the underreporting of adverse drug reactions.

MetroDoctors

The Journal of the Hennepin and Ramsey Medical Societies

active ingredient, less than half had an adequate amount. Less than the minimal acceptable amount was present in 32 percent of the products, and 22 percent had no detectable active ingredient. Again, these examples are just a sampling. Standardization of the active ingredient may help prevent this problem, which some manufacturers are using. However, it has not been determined if standardization is the ideal approach for all herbal products; many ingredients in a plant may work synergistically. Product claims The FDA is responsible for product labeling, which includes information written on the bottle, on the package, or on a package insert, and materials distributed at the point of sale. Dietary supplements can have labeling claims of a product affecting the structure or function of the body (“structure/function” claims), but not claims that a product can prevent, treat, or affect disease (“disease” claims). For example, a claim of “maintains urinary tract health” is allowed, while “treats urinary tract infections” is not. Previously, it was often difficult to tell the difference between these claims, especially for consumers. Sometimes, the structure/function claims sound better than disease claims! Therefore, the FDA finalized rules for claims on dietary supplements in January 2000. Now, dietary supplements are not allowed to bear either express disease claims (e.g., “treats diabetes”) or implied disease claims (e.g., “controls blood sugar”). Previously, implied disease claims were allowed. Banning these implied disease claims is a huge step for the FDA. However, under the new ruling, these express and implied disease claims CAN be made by the name of the product (e.g., “Migraine B-Gone”), a statement about the product formulation (e.g., “contains aspirin”), or through pictures, symbols or vignettes (e.g., EKG tracings, picture of heart). Additionally, claims that are not related to disease are allowed, which include health maintenance 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, mild memory loss associated with aging) are no longer considered diseases. Manufacturers can make claims about these conditions. MetroDoctors

Do claims of effectiveness need to be backed up with data? Structure/function claims actually do not require FDA review. Manufacturers are required to have (in their files) substantiation of any claims they make, but the “substantiation” is not currently reviewed. When claims are written on product labels, a disclaimer must be included that they are not drugs and receive no FDA pre-market approval. Usually included is “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease.” Advertising The FDA is not responsible for overseeing advertising for dietary supplements. This falls under the Federal Trade Commission (FTC), and includes print ads, broadcast ads, infomercials, catalogs, direct marketing materials and the Internet. If any advertising appears to be false or misleading, or without substantiation, complaints can be filed to the FTC by calling toll free 877-FTC-HELP or by submit-

The Journal of the Hennepin and Ramsey Medical Societies

ting an on-line complaint at www.ftc.gov/ftc/ complaint.htm. The Future of Dietary Supplement Regulation The Center for Food Safety and Applied Nutrition (CFSAN) of the FDA recently published a document entitled Dietary Supplement Strategy: Ten Year Plan, which outlines the strategy to reach their goal to have a “science-based regulatory program,” which will provide consumers with a “high level of confidence in the safety, composition, and labeling” of dietary supplements. The plan is to fully implement the DSHEA. Steps to reach the program goal are outlined in detail in the document, and are summarized in Table 1 on page 22. This is a great endeavor by the FDA, and will be monumental in providing consumers confidence in dietary supplements. Some issues remain to be unresolved, such as if dietary supplements should

(Continued on page 22)

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(Continued from page 21)

be required to undergo pharmacokinetic testing to identify drug interactions and dosage reductions in renal and hepatic dysfunction. Should safety be documented prior to marketing? Should compounds be evaluated in pregnancy and lactation? If such measures were in place, more confidence could be placed in using dietary supplements, and monitoring might be done if potential side effects (subjective and objective) were known. Ideally, dietary supplements should be required to pass tests for safety and effectiveness and meet drug standards for strength, quality and purity.

Conclusion Use of dietary supplements is expanding and is continuing to grow. Currently, little regulation by the FDA is in place, which leaves a lot of unknowns with regards to safety, composition, contamination, and efficacy. The ten-year plan set forth by the FDA’s Center for Food Safety and Nutrition is an ambitious undertaking, and will help solve many of the current unresolved issues with regard to dietary supplements. The future of medicine will likely see increasing use of complementary medicine, both as sole therapy and in conjunction with allopathic medicine. If improved regulatory measures are implemented, they will provide con-

sumers and health professionals with more confidence in the safety, labeling, and composition of dietary supplements. ✦

Donald Asp, M.D., is an associate professor, Department of Family Practice and Community Health Medical School, University of Minnesota. Ila Mehra Harris, Pharm.D., BCPS, is an assistant professor, Department of Pharmaceutical Care and Health Systems, College of Pharmacy, and a clinical assistant professor, Department of Family Practice and Community Health Medical School, University of Minnesota.

Table 1. Dietary Supplement Strategy: Ten Year Plan of the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) I. SAFETY A. Enhance adverse event reporting B. Good Manufacturing Practices (GMP) 1. Publish regulations on GMP and establish an outreach and ongoing inspection program. C. Health hazard evaluations 1. Enhance mechanisms for evaluating health hazards of dietary supplement ingredients and contaminants. D. Dietary supplement safety database E. New dietary ingredients 1. Notifications 2. Guidance. Develop guidance for safety substantiation for pre-market notifications for new dietary ingredients. 3. Database. Incorporate pre-market (75-day) notifications in the comprehensive 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. LABELING A. Implement Pearson v. Shalala court decision B. Response to health claim petitions C. Database for label claim notifications D. Substantiation 1. Identify criteria for substantiation of structure/function and related claims and identify conditions for sharing substantiation documents. E. Publish final rule on claim notifications based on authoritative statements F. Consumer and marketplace labeling surveys G. Resolve issues about third party publications H. Resolve small business exemptions III. BOUNDARIES A. Publish final rule on structure/function claims B. Clarify dietary supplement vs. drug C. Clarify dietary supplement vs. conventional foods D. Develop regulatory framework for botanicals E. Dietary supplement exclusions

March/April 2000

F. Clarify dual status G. Clarify regulation of combination products H. Clarify dietary supplement vs. cosmetic IV. ENFORCEMENT ACTIVITIES A. 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 inaccurate and misleading labeling and consumer fraud, including trade complaints. 4. Routine compliance. Maintain routine compliance activities, incorporating enforcement of final rules. 5. Surveillance and monitoring 6. Establish partnerships with federal, state and local agencies to enhance enforcement. B. Capacity building C. Federal Trade Commission (FTC) Coordination. Enhance coordination with FTC on enforcement cases. V. SCIENCE BASE A. Strengthen science-base 1. Strengthen research efforts, including agenda, capabilities, leveraging, peer-review, and ingredient review. B. Regulatory oversight and science-based standards for human studies C. Improve adverse event report monitoring system D. Claims 1. Distinguish “valid substantiation” for claims (structure/function) from “invalid substantiation” for claims. E. Explore development inter-agency clearinghouse VI. OUTREACH A. Establish advisory committee B. Additional stakeholder outreach C. Communication D. Enforcement policies and procedures

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The Journal of the Hennepin and Ramsey Medical Societies

NOTEWORTHY “Orientation to Immigrant and Cross-Cultural Health”

Preparing for Minnesota’s New Area Codes

www.metrodoctors.com— Update

Effective February 27, 2000, the Minneapolis metropolitan region served by the 612 area code was split into three different area codes: 612, 763 and 952. The 612 area code was kept by Minneapolis, Richfield, St. Anthony and the Fort Snelling area. Phone numbers for HMS, RMS and MMA executive offices were not affected and remain 612.The boundary line separating the 763 area code from the 952 area code approximately follows Interstate 394. For the most part, communities located north of I-394 and to the north and northwest of Minneapolis have the new 763 area code. Communities south of I-394 and to the south and southwest of Minneapolis have the 952 area code. Mandatory use of the new area codes and ten-digit dialing for local calls between area codes in the Twin Cities metro area will begin on January 14, 2001. Additional information is available at the following web sites: www.mnta.org, or www. uswest.com/areacodes.

The joint web page of the Ramsey and Hennepin 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 642 hits per day. • Monday and Tuesday are the busiest days and over the lunch hour is the busiest time. • The vast majority of visits are for the purpose of using the “find a doctor” function. • A stepped up advertising campaign is about to be undertaken and a new look for the home page will be installed in early March. Have you taken the time to complete your personal mini-web page? If not, the site user is not getting all the information that they may need to choose your practice. You can build your own personal mini-web page by going to www.metrodoctors.com/census and completing the on-line census sheet.

Best Practices for the Care of Adolescents A half-day course, “Healthy Transitions: Best Practices for the Care of Adolescents,” will be held April 14 in the Pillsbury Auditorium, Hennepin County Medical Center. Providers will learn about tools and resources to improve adolescent health practice. The course includes: • Showcase of Best Practices in Adolescent 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, Continuing Medical Education, 612/347-2075. MetroDoctors

Celebrating a Century of Success On April 7, the Public Health Partnership 2000 invites you to attend a celebration of public health accomplishments during the last century. This is an opportunity to support collaboration in public health and confirm our commitment to improved health for all Minnesotans. It will be held at Earle Brown Heritage Center in Brooklyn Center. Former Surgeon General Joycelyn Elders, M.D., is the keynote speaker. Commissioner of Health Jan Malcolm is honorary co-chair of the event. For more information, contact Tricia Todd at 651/638-9855.

The Journal of the Hennepin and Ramsey Medical Societies

This spring, Health Advocates offers “Orientation to Immigrant and CrossCultural Health.” This course, co-sponsored by HealthEast, Minnesota International Health Volunteers and the Center for CrossCultural Health, is designed for health care professionals and students who anticipate working in the U.S. with patients and clients whose country of origin, language, customs, and values may differ from their own. Participants in the 10-week course are eligible for 20 continuing education contact hours. Classes will be held on Thursday evenings from 6:30 to 9 p.m. at the HealthEast Midway Health Services Building in St. Paul. The series begins on March 16, 2000 and runs through May 18. For more information, contact Barbara Babbitt, at 612/920-8944. ✦

Classifieds ERGONOMIC SOLUTIONS: Occupational Therapist provides on-site workstation evaluations for clients experiencing musculoskeletal disorders to assure proper body mechanics and workstation design. Benefits are reduced pain, headaches, and risk of repetitive strain injuries. Techniques used to alleviate migraine headaches in minutes without medication. Contact Patricia Brown, OTR 612/971-1372.

PARTNERING OPPORTUNITY FOR FAMILY PRACTICE: Board Certified Family Physician seeking Board Certified Family Physician, other Primary Care, OB-GYN, or specialty physicians, to share office facility in West Metro area. Practice site being developed will serve up to six full-time plus part-time medical or surgical specialists. If you have interest, please contact Alfonso Morales, M.D., at Southwest Family Practice P.A., 612/803-8273. ✦

March/April 2000

PRESIDENT’S MESSAGE J O H N R . G AT E S , M . D .

It is Time to Act 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-Elect Raymond Bonnabeau, M.D., Sr. Physicians Association President Kenneth W. Crabb, M.D., AMA Alternate Delegate Stephen P. England, M.D., Community Health Council Chair Michael Gonzalez-Campoy, M.D., Education Resource Council Chair Duchess Harris, Alliance Co-President Nicki Hyser, Alliance Co-President Frank J. Indihar, M.D., AMA Delegate William Jacott, M.D., U of MN Representative F. Donald Kapps, M.D., Council on Professionalsim & Ethics Chair Melanie Sullivan, Clinic Administrator Lyle J. Swenson, M.D., Public Policy Council Chair Russell C. Welch, M.D., Communications Council Chair RMS-Executive Staff

Roger K. Johnson, CAE, Chief Executive Officer Doreen Hines, Assistant Director

March/April 2000

IT HAS BEEN MY PRIVILEGE to practice

medicine in St. Paul, Minnesota, for the last 20 years. This has been a time of tremendous technological advances for the treatment of a multitude of medical conditions. In my specialty alone, our imaging has traversed the spectrum from direct carotid puncture angiography and pneumoencephalography to functional magnetic resonance imaging to magnetoencephalography and positron emission tomography scans. I have had the opportunity to integrate these new technologies into my practice to offer true state-of-the-art medical service for my patients with epilepsy. I have had the privilege of practicing in a medical community that I have always felt was second to none in the United States. The quality of primary care and specialty care that we have in the Twin Cities, especially in the east metro, in my opinion, is extraordinary. Moreover, we have delivered this treatment in an exemplary, fiscally responsible manner. Uwe Reinhardt, Professor of James Madison Political Economy at Princeton University said: “If everyone practiced medicine like they do in Minnesota, we probably wouldn’t have the fiscal health care crisis that we currently have.” In fact, he actually doubts that we are part of the United States because of this apparent aberrant behavior. Despite these extraordinary achievements, both fiscally and qualitatively, I believe we are currently teetering on the edge of collapse of our health care delivery system. I have had a personal family episode of care that was far from optimal and quite frankly, frightening. It involved, in my opinion, clear cost-cutting measures that were risky in terms of medication use, or should I say lack of medication use, and inadequate nursing staffing ratios for immediate post-operative care. Repeated requests to the nurse for over 30 minutes to get assistance for escalating post-operative deterioration went simply unmet and not acceptable. Similarly, I have found access to follow-up apMetroDoctors

pointments, even at my own physician’s office, difficult to obtain. I discovered follow-up appointments not available for three to four months, after 20 minutes on hold. With the recent flu epidemic, the emergency delivery system has been particularly strained, but even before that explanation we have had a record number of emergency room and hospital diverts in the east metro. If a 747 went down requiring immediate availability of 300 or more hospital beds, we would be in serious difficulty as just finding an extra bed for pneumonia cases right now proves to be a challenge. Anecdotally, I have heard of physician colleagues retiring early, many primary and specialty groups having difficulties recruiting, and delayed integration of new life-saving technologies due to fiscal and administrative entanglements. At this time of the best and most sustained economic growth, Harvard Pilgrim Health Plan made the front page of the New York Times because it is in receivership. Locally, retrenchments are in process at several metro systems, including Fairview University and HealthSystem Minnesota. We’ve tried to handle it ourselves but it is not working. It is time to recruit the public and begin to apply some added pressure to HCFA, federal and state legislatures, and insurers. We need to state, in no uncertain terms, that the system is deteriorating rapidly for regulatory, administrative and economic reasons. It is my promise as Ramsey Medical Society president to get the word out to the community that we have a health care delivery system second to none but we can’t predict how much longer this will be true. We need to define quickly what we will do as a community of patients and health care providers to insist on the preservation of our pre-eminence. ✦ The Journal of the Hennepin and Ramsey Medical Societies

RMS ALLIANCE NEWS ELEANOR M. GOODALL

The Alliance, A Federation Let’s look at this within the context of the Alliance. As members of the Federation of the American Medical Association Alliance and the Minnesota Medical Alliance, along with thousands of other spouses of physicians throughout the United States, we share a “global” perspective as we endeavor to promote the health and well-being of our communities. The legislative agenda and ideas for political action are global. The strategies to recruit new members, fundraising ideas, a focused voice on health concerns and issues — all are the result of global thinking. Local Programs As members of the Ramsey Medical Society Alliance we’re part of the acting locally efforts. Specifically, the mission of the Alliance is to promote educational and charitable endeavors which improve the health and quality of life of our community. I’d like to touch on a few of the ways the Alliance and its members act locally by providing funds and volunteers. First Steps: A mentoring program for teen moms, based out of United Hospital. With the consent of the new mom, volunteers visit her and her baby in the hospital and keep in touch by phone, visits and social gatherings for three to six months after the birth of the baby. We MetroDoctors

also help the moms access other services and simply offer companionship. Wigs Without Worry: A service that provides high quality wigs, at no cost, to individuals suffering hair loss due to medical treatment. Caring Hearts for the Homeless: A partnership of the Alliance with Ramsey Medical Society and HealthEast to collect hygiene supplies and monetary donations for homeless persons in St. Paul. Funds have been used for such services as purchasing prescription drugs for homeless women and children.

Perhaps the largest local undertaking to promote health is the annual week long Health Fair. Sexual Violence Center: A program serving victims and families of sexual violence, ranging from sexual harassment to rape. Volunteers and staff offer community education in all grades of schools and with adult groups centering around prevention. And, there are many other programs through which Alliance members serve their community. Health Fair: Perhaps the largest local undertaking to promote health is the annual week long Health Fair. Here, hundreds of third grade children from St. Paul schools learn about how their bodies work and how to keep themselves

The Journal of the Hennepin and Ramsey Medical Societies

healthy. They learn about what happens when they are admitted to a hospital or have to go to an emergency room, why tests and procedures are performed and best practices for prevention. The smiles, excited chatter and positive comments from teachers and parents in attendance tell us this is a valuable way to “act locally.” So What? So, you might ask, what’s this got to do with anything? From the esoteric global thinking to the concrete local action — why do we, as Alliance members, do this? In truth, I can only speak from my own perspective. However, I’ve shared enough cups of coffee, time, energy, and effort with Alliance members, “globally” and locally, that I have a sense of why. Because we care. Because most of us feel pretty fortunate about our lives and regard our Alliance work as an opportunity to give back. And, simply because we have a life to lead and want to lead it the best way we can. You know, it’s so easy to waste our lives, our days, our hours, our minutes. It’s so easy to take things for granted, to exist instead of live. And sometimes it’s so hard to go that extra mile as an Alliance volunteer, but it’s worth it. Get a Life The spouses of physicians that I’ve worked with in the Alliance have learned that it’s the journey that’s important, not the destination; that life isn’t a dress rehearsal and that today is the only guarantee we’ve got. Alliance members are busy people with full lives. The job of giving to others, of helping our communities improve their health and quality of life only makes our lives fuller. The phrase, “Get a Life,” doesn’t have meaning in the Alliance. We’ve already got one! ✦ March/April 2000

Ramsey Medical Society

Think Globally, Act Locally How many times have you heard the statement, “Think globally, act locally?” And, what, exactly does it mean? The “think globally” part gets easier all the time. We have free trade with Mexico and Canada. Travel to far off places is common. We even have Jesse extolling the virtues of Minnesota to the Japanese. The “act locally” piece is a little harder to get a handle on. To my mind, it says that actions on behalf of the world are just too enormous for us to grasp, let alone do anything about. But, if each of us does our own part close to home, together we can change things.

RMS NEWS

Dr. John Gates Installed as President Tim Penny Discusses Medicare Reform at RMS Annual Meeting

DR. JOHN R. GATES, was installed as the 129th president of the Ramsey Medical Society on Thursday, January 27, 2000, at the University Club by Dr. Lyle J. Swenson, past president. Dr. Gates is the president of the Minnesota Epilepsy Group and he is a board certified neurologist. He is also active in the American Academy of Neurology, Stratis Health, the MMA, the Minnesota Epilepsy League, and the Association of Neurologists of Minnesota. Dr. Gates resides in North Oaks with his wife, Rita Meyer, and three children. Dr. Gates pledged to educate the public regarding the threats to the health care system and to work to influence public opinion. He also advocated for physicians stating that with the support of patients and the public the threats to the health care system can be eliminated and positive change can be made both in the public policy arena and within the health care delivery system itself. The 1999 Ramsey Medical Society Community Service Award was presented to Dr. Neal

Dr. Lyle Swenson presents Dr. Neal Holtan with the Community Service Award.

March/April 2000

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

Holtan, medical director of the St. Paul-Ramsey County Department of Health. Dr. Holtan has an exemplary record of achievements in public health. He is a co-founder of the Council for Preventive Medicine. He has a long record of involvement with the Center for Population Health and the Center for Victims of Torture. He plays a leadership role in the University of Minnesota School of Public Health Alumni Association and he has chaired the MMA Committee on Public Health and the RMS Council on Community Health. He is board certified in internal medicine and is completing a Bush Fellowship in the History of Medicine and Public Health.

Former Congressman and U.S. Senate Candidate Tim Penny spoke to the large gathering of RMS members, spouses, and representatives of other medical organizations. Penny told the audience, â&#x20AC;&#x153;Todayâ&#x20AC;&#x2122;s Medicare, with its

Dr. Lyle Swenson passes the gavel to Dr. John Gates.

MetroDoctors

The Journal of the Hennepin and Ramsey Medical Societies

Sommerdorf.

Applicants for Membership We welcome these new applicants for membership to the Ramsey Medical Society.

Active Steven F. Lucas, M.D. University of Minnesota Family Practice HealthPartners (Apple Valley) Student (from the University of Minnesota) Patrick G. Carey Tammy N. Comstock Jamison L. Harker Jennifer A. Lessard David M. Tierney Transfer into RMS — Resident Donavan J. Hess, Jr., M.D. University of Minnesota ✦

In Memoriam

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

Dr. Charles and Pat Crutchfield.

HERBERT L. KLEMME, M.D, a retired psychiatrist, died January 13 from complications from a stroke. He was 77. He completed medical school at the University of Arkansas. Dr. Klemme practiced general medicine in Iowa and Arkansas before entering a psychiatry residency at the Menninger School of Psychiatry in Topeka, Kansas in 1960. Upon completion, he remained as senior psychiatrist until 1975. Dr. Klemme came to Minnesota in 1975 and practiced general psychiatry until he retired in 1993. ✦

Reminder… metrodoctors.com census sheet can be completed on-line. Dr. Brett Teten, Lisa Hammerbeck, Dr. Alec Dunkel, Dr. Diane Dahl, Dr. Thomas Dunkel, Tim Penny, and Dr. Lyle Swenson.

MetroDoctors

The Journal of the Hennepin and Ramsey Medical Societies

www.metrodoctors.com

March/April 2000

Ramsey Medical Society

most effective treatments and medications at the government dictated, one size fits all benefit lowest feasible cost. Such a program could be plan, doesn’t cut it. To make the program work modeled after the benefits program offered to in the 21st century, we need to trust consumers federal employees.” ✦ —Medicare beneficiaries — to use their power of choice to make the program more effective and efficient.” Mr. Penny continued, “If, however, each Medicare beneficiary could choose from a variety of health plans and benefit packages, and choose the option that offered the most desired services at the best value, then you would see health plans engaged in vigorous competition to offer the latest, Tim Penny with Dr. Michael Spence, Sherry Spence, and Norma

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March/April 2000

Call 612/623-2860 e-mail: mmbr@mnmed.org internet: mnmed.org/mmbr MetroDoctors

The Journal of the Hennepin and Ramsey Medical Societies

HMS IN ACTION JACK G. DAVIS, CEO

HMS-Officers

HMS-Board Members

Michael Belzer, M.D. Carl E. Burkland, M.D. Herbert K. Cantrill, M.D. Penny Chally, Alliance Co-President William Conroy, M.D. Rebecca Finne, Alliance Co-President James 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 Association Lee H. Beecher, M.D., MMA-Trustee Karen K. Dickson, M.D., MMA-Trustee John W. Larsen, M.D., MMA-Trustee Robert K. Meiches, M.D., MMA-Trustee Henry T. Smith, M.D., MMA-Trustee Robert Finke, MMGMA Rep. HMS-Executive Staff

Jack G. Davis, Chief Executive Officer Nancy K. Bauer, Associate Director

HMS in Action highlights activities that your leadership and executive office staff have participated in, or responded to, between MetroDoctors issues. We solicit your input on these activities and encourage your calls regarding issues in which you would like our involvement.

Twenty-five HMS members, board and nonboard representatives, participated in a fivehour strategic planning retreat in January. Key activities for future focus included membership, member-to-member collegiality, physician activism, communications, and revisiting the HMS mission statement and board structure. Virginia Lupo, M.D. and Lyle Swenson, M.D. presented congratulatory Cross Pens to first year medical students on behalf of HMS and RMS at the University of Minnesota’s White Coat Ceremony.

The HMS Abuse Prevention Project has changed its name to the Healthy, Abusefree Workplace Project. A workshop on “intervention strategies” is being developed. Planning for the 2000-2001 school year immunization requirement notification has begun. Fifteen school districts will participate in the No Shots. No School. initiative. HMS is coordinating the mailing to physicians and nurse practitioners. Drs. David Estrin, Timothy Komoto and Dawn Martin have again agreed to serve as the physician cochampions of this immunization initiative. Jack Davis and Nancy Bauer attended the annual meeting of the Ramsey Medical Society. John M. Gates, M.D.

was installed as their 129th president. The Adolescent Health Care Coalition is co-sponsoring a “best practices” conference with HCMC Department of Pediatrics. Dr. Julia Joseph DiCaprio is the conference chair.

MetroDoctors

The Journal of the Hennepin and Ramsey Medical Societies

One hundred and thirty medical students attended the “Lunch ’n Learn” session sponsored by HMS and RMS. Drs. Eric Bothun (2nd year University of Minnesota Ophthalmology resident) and Dwenda Gjerdigan, Bethesda University Family Practice Clinic, spoke on the “Idealism of Medicine” and how to keep the fire alive. Nancy Bauer attended a meeting of the Caring Clinics task force, evaluating the west suburban pilot project. The purpose of the pilot is to explore ways to provide medical care to the uninsured (St. Mary’s Clinic population) by “mainstreaming” them into existing primary care clinics. Look for an article in the May/June issue of MetroDoctors on this pilot. Several meetings have taken place between HMS, Ramsey Medical Society, Minnesota Medical Association and MMIC for the purpose of building a collaborative relationship within and between each of the organizations Web strategy. Considerable interest exists for taking the physician directory, developed within “metrodoctors.com,” to a statewide audience. Several HMS physicians attended an informal lunch meeting with Attorney General Mike Hatch at his offices. The purpose of the meeting was to hear, review, and discuss Mr. Hatch’s health care priorities. Jack Davis continues to attend meetings of the Medicare Justice Coalition. The

lawsuit, which challenges HCFA and the geographic disparity in reimbursement, is progressing. Jack Davis has been an invited guest of the bimonthly meetings of the Board of the Hennepin Chapter of the Minnesota Academy of Family Practice.✦

March/April 2000

Hennepin Medical Society

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 NEWS

HMS Plans for the Future HMS KICKED OFF the new millennium with

a sense of great vigor and accomplishment at a strategic planning retreat held on January 20, 2000. Twenty-five members of the Board and a few invited guests gathered for five hours for review of accomplishments, membership trends and brainstorming for the future. A number of challenges were identified, primarily in the areas of declining membership and unclear value/relevance to the membership, physician apathy, representative Board structure, and scarce resources requiring and limiting collaboration with other organizations. At the same

time, a number of opportunities were also brought forward: • become an attractive organization to all members; • more interaction with medical students and residents through mentoring programs and camaraderie; • “intentional collegiality,” i.e. redefine how to be colleagues and improve doctor-todoctor communication relating to patient care; and • pursue multiple collaborations and communicate our value to other entities.

Family Event at the Minneapolis Institute of Arts “STAR WARS: The Magic of Myth” Don’t miss this rare opportunity to discover the creative world of George Lucas and the entire Star Wars saga in this spectacular exhibition. Explore the message of the epic struggle between good and evil in the films, and discover links between Lucas’ modern classics and powerful mythological themes from many cultures and times.

FRIDAY, MAY 5, 2000 Tours at 6:30 and 7:00 p.m. Join us for a complimentary ice cream social following the exhibit tour in the Norwest Room DISCOUNT TICKETS: $5/person Deadline for ordering tickets is Monday, April 3, 2000 For more information, call Nancy Bauer at 612/623-2893. Sponsored by: Hennepin Medical Society and Hennepin Medical Society Alliance

March/April 2000

MetroDoctors

In addition, the mission of the Hennepin Medical Society was reviewed in context to its strategic objectives. It reads, The mission of the Hennepin Medical Society is to serve its members and the community by promoting wellness and identifying and addressing health care issues in the west metro area. The group concurred that a revision was in order. Members are encouraged to submit their revisions. The HMS Executive Committee has since met and identified the following areas of primary focus for the leadership, committee members and staff of the Hennepin Medical Society: revisit the mission statement and representative structure of the Board; promote the value of membership through enhanced communications and focused membership marketing efforts (including professional collegiality); pursue physician activism, and multiple collaborations. Both the Membership and Communications Committees have been re-energized and given specific tasks to address these areas. If you are interested in participating in either of these committees, or any other HMS activity, please contact Nancy Bauer at 612/623-2893 or email: nbauer@mnmed.org. ✦

Call for Delegates and Resolutions ARE YOU INTERESTED in serving as a Del-

egate to the MMA House of Delegates? The MMA’s Annual Meeting is scheduled for September 13-15, 2000 in Duluth. HMS will be holding its caucus June 14, 7:00 a.m., at which time the Delegates will discuss and vote on resolutions submitted by its members. The resolutions that pass at the Caucus will then be forwarded to the MMA House of Delegates for consideration. If you have resolutions that you would like to have considered at the HMS caucus, please submit your resolution or ideas by Friday, May 26. To serve as a Delegate, or for more information, please contact Kathy Dittmer at 612/ 623-2885, email: kdittmer@mnmed.org, or fax at 612/623-2888.✦ The Journal of the Hennepin and Ramsey Medical Societies

In Memoriam

Hennepin Medical Society

HAROLD KATKOV, M.D., a pediatric cardiologist, died in January. He was 72. Dr. Katkov founded the Children’s Heart Clinic in Minneapolis in 1970. He was born in St. Paul and graduated from the University of Minnesota Medical School. He completed his residency at the University Hospital in pediatrics, followed by training in pediatric cardiology at the Variety Heart Hospital. Dr. Katkov was a clinical associate professor in pediatrics at the University of Minnesota. He joined HMS in 1962. ALEXANDER LIFSON, M.D., a neurosurgeon who emigrated from Russia 22 years ago, died from cancer on December 25. He was 59. Dr. Lifson worked at the Institute for Low Back and Neck Care in Edina. In 1976 he expressed an interest in leaving his homeland and in 1978 received a fellowship to work at the Edina center. He became a member of HMS in 1979. JOSEPH S. MASSEE, M.D., 70, died on

January 17. He was an obstetrician/gynecologist for 45 years at the Mayo Clinic, Cook County Hospital in Chicago and North Memorial and Fairview Southdale Hospitals. Dr. Massee founded Obstetrics Gynecology, Infertility, Ltd. and was instrumental in establishing a women’s health center at North Memorial. He graduated from the University of Minnesota. He joined HMS in 1964. JAMES F. SHANDORF, M.D., an obstetri-

cian-gynecologist, died in February at the age of 90. He graduated from the University of Minnesota Medical School and completed his internship and residency at Minneapolis General Hospital. He also completed an OB/Gyn Fellowship at New York Hosptial. Dr. Shandorf joined HMS in 1943. DAT VAN TRUONG, M.D., died December 29 at the age of 61. A family practitioner, he worked in the Twin Cities since 1979. He graduated from the Medical University School of Medicine and Pharmacy, Viet Nam. Dr. Truong became a member of HMS in 1984.✦

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March/April 2000

HMS ALLIANCE NEWS P E N N Y C H A L LY

FROM THE HENNEPIN MEDICAL Society Alliance to all physicians: March 30 is Doctors’ Day. We wish to recognize you all — particularly on this day — as hard-working physicians committed 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 possible, and work with families and friends of those in crisis. We recognize the many physicians who are committed to working within the community, and some internationally, on a volunteer basis to help those who have healthcare needs which otherwise could not be met. The Hennepin Medical Society has itself been involved in a number of important health related community projects: Dakota Healthy Families; Success by 6®; Healthy, Abuse-free Workplaces, No Shots. No School; HealthSpeak; and Adolescent Health Care Coalition. We wish to thank you all! We also wish the Hennepin Medical Society a happy 135 years. As co-presidents of the Alliance, Becky Finne and I have the privilege of sitting on the HMS Board this year and we have learned a great deal from this experience. Recently the Board met and conducted its annual planning event. It was quite efficiently and thoughtfully run. Information was shared as to accomplishments of the Society, places where progress had been less than expected, and a data review of the board members survey. Then the Board analyzed the information and developed a list of challenges and opportunities the HMS faces in 2000. New strategic initiatives were

developed which will work towards achieving HMS long-term strategic objectives, ending with a discussion on possible next steps. It was a most positive process and we left with much food for thought! As HMS is 135 years old in 2000, the Hennepin Medical Society Alliance is 90 years old in 2000 — ninety years in existence supporting our physician spouses, ourselves and our families, and our community by a variety of ways. We have not been a static organization; we have changed the means of support to adjust for the needs of the times, and will continue to do so. What is important to realize, however, is that the need for the Alliance never changes. First, our physician spouses always need our moral support; we always need to be vigilant in their cause as the field of healthcare shifts in its struggle to understand itself and redefine itself. Secondly, there always will be community health needs that provide avenues for the Alliance to help through education, advocacy and service. Thirdly, there always will be a need for friendships and the Alliance is a wonderful place to find friends — friends from all ages and stages of life: spouses of medical students; spouses of residents; spouses of practicing physicians; and spouses of retired physicians. Each and every one of us brings something special to the Alliance. Now is the time to remember the best, and then use it while continuing to create something even more special as we move into the next century. BODYWORKS 2000 will be quickly

Thank You Doctors

National Doctors’ Day March 30 32

March/April 2000

MetroDoctors

upon HMSA — this year we will be having the week-long event from February 28-March 3 in the Lutheran Brotherhood Auditorium — space that Lutheran Brotherhood has donated to HMSA for 13 years. This event is an example of keeping the best and making it better. The program was created to give a “hands-on” health experience for third grade children that would be fun, informative and useful. Over 100 volunteers have staffed BODYWORKS each year, with hundreds of hours of preparation donated before the event. Teacher evaluations indicate that this event is a terrific educational opportunity and resource. Ideally, we wish we could serve all third grade students in the area; however, with limited time and resources, we offer this on a first come, first serve sign-up basis. Many classrooms are turned away each year. The HMSA initiated another project four years ago — the HIV/AIDS Education Folder. Last year this educational tool became a State Alliance project and in the fall of 1999, this folder was given to 160 Middle Schools around Minnesota at no expense to the schools. Again, the best was used and the folder was updated with phone numbers and added information on Hepatitis C. The goal of the folder is to help young students make educated choices so that they can develop and maintain healthy, active lives. The HMSA is taking on another program that will help young people. This project, aimed at helping the teen/high school age person, is to help raise funds for the Teen Annex. It takes time and preparation for a new project; but research into the needs of a community and how the Alliance can best make an impact is the key to success. For 90 years, HMSA has understood this and has made a difference by identifying these needs and then acting to help where needed — whether it has been our spouses, our friends or our community.✦ The Journal of the Hennepin and Ramsey Medical Societies