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Disease mongering and drug marketing

Shidonna Raven Garden and Cook

Howard Wolinsky
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Source: US National Library of Medicine – National Institutes of Health
Featured Photo Source: Unsplash, National Cancer Institute

Summary

Does the pharmaceutical industry manufacture diseases as well as drugs?

Most people may not have heard of metabolic syndrome, but that is likely to change. Once known mysteriously as Syndrome X, the condition, a precursor to heart disease and type 2 diabetes, is about to be transformed into a household name by the US pharmaceutical industry and its partners in the medical profession. A society dedicated to addressing the condition has been organized, a journal has been started, and an education campaign launched. Patients are already being tested for metabolic syndrome. As the trade publication Pharmaceutical Executive said in its January 2004 issue: “A new disease is being born” (Breitstein, 2004).

…industry has found itself under fire from detractors who contend that, in the pursuit of profits, companies are in league with medical doctors and patient advocacy groups to ‘disease monger’…

The situation is reminiscent of the attitude towards cholesterol. Twenty years ago, physicians were not concerned about the effects it might have on heart disease. Today, thanks to efforts by pharmaceutical companies, high cholesterol levels are now recognized as a major health problem. In fact, IMS Health, a global healthcare information company, reports that the two best-selling drugs in 2004 were statins: Lipitor® (atorvastatin calcium) from Pfizer (New York, NY, USA)—valued at US$10.6 billion with growth of 13.9% over the previous year—and Zocor® (simvastatin) from Merck (Whitehouse Station, NJ, USA). Pharmaceutical Executive noted: “The emergence of cholesterol reduction as a market was a major event for pharma. Metabolic syndrome promises to be as big or bigger” (Breitstein, 2004).

However, critics note that not every new disease for which the pharmaceutical business provides a drug is necessarily a major public health problem, but rather a venue for drug companies to increase revenues. Pharmaceutical companies research, develop and exploit drugs to prevent, control and cure diseases and treat symptoms. Companies then market these medications to recoup their investments and reward shareholders. It would seem to serve the interests of society, but some critics characterize it as a vicious circle in which businesses invent new diseases to match their existing drugs. Increasingly, industry has found itself under fire from detractors who contend that, in the pursuit of profits, companies are in league with medical doctors and patient advocacy groups to ‘disease monger’: convince people that their usually mild ailment urgently needs drug treatment.

The late medical journalist Lynn Payer addressed the issue in the early 1990s in her book Disease-Mongers: How Doctors, Drug Companies, and Insurers Are Making You Feel Sick. She wrote: “Disease-mongering—trying to convince essentially well people that they are sick, or slightly sick people that they are very ill—is big business…. Disease mongering is the most insidious of the various forms that medical advertising, so-called medical education, and information and medical diagnosis can take.” Similarly, Arthur Caplan, Professor of Bioethics at the University of Pennsylvania, Philadelphia, USA, last December told the popular American TV programme 60 Minutes, “If you want to stir up worry in the public, and you’ve got the advertising dollars to do it, you can turn almost anything into a disease.” The focus of the 60 Minutes report was the recent emergence of a market for adult attention deficit disorder (ADD)—the traditional view was that ADD afflicted only children who would eventually outgrow it.

Critics such as Payer and Caplan maintain that the routine human condition…is increasingly being re-defined as disease…

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Critics such as Payer and Caplan maintain that the routine human condition—unhappiness, bone thinning, stomach aches and boredom—is increasingly being re-defined as disease: depression in its milder forms, osteoporosis, irritable bowel syndrome and attention deficit disorder. Likewise, risks factors, such as high cholesterol and high blood pressure, are declared diseases in their own right—hyper-cholesterolaemia and hypertension—with falling thresholds resulting in more people considered to be sick. In other cases, drugs approved for devastating illness, such as clinical depression, are indicated for milder conditions, such as shyness, which is now dubbed ‘social phobia’.

One such example is Strattera® (atomoxetine hydrochloride), developed by Eli Lilly & Co. (Indianapolis, IN, USA) and approved in November 2002 by the US Food and Drug Administration (FDA) for treating ADD in children, teens and, for the first time, adults. One Lilly advertisement shows a series of photographs of an uptight-looking model, and asks in the headline: “Distracted? Disorganized? Frustrated? Modern Life or Adult ADD?” The advertisement notes that adult ADD can go undiagnosed because “its symptoms are often mistaken for a stressful life.” The commercial suggests that readers get checked out by their physician, because Strattera®, the first approved medication for adult ADD, can help “you stay focused, so you can get things done at work and at home.”

“I certainly have watched adult attention deficit disorder start to spread out from the first grade/kindergarten crowd right up to adulthood. I am suspicious because I think that this expansion is fuelled by Lilly and Strattera®,” Caplan commented. “I don’t like the way their website [suggests that] people go pester their doctor if they have problems waiting in lines or get frustrated being put on hold on the phone.” Lilly did not respond to a request for comment.

Adult ADD has been a favourite target of the critics. But psychiatrist Peter Jensen, a mental health researcher at Columbia University (New York City, NY, USA), concedes there is a dearth of epidemiological research on adult ADD, which can be a real condition that impairs and disables people. “Pharmaceutical companies are businesses that are out there to make money and sell things. But saying that diseases are invented seems a little over the top. [Companies] certainly spread information and increase awareness, but you can’t sell it to the FDA that way,” said Jensen, who serves on the governing board of Children and Adults with Attention–Deficit/Hyperactivity Disorder (CHADD; Landover, MD, USA), a non-profit patient support group. “Illness is defined in a social context. Value systems are inherent in medicine. With adult attention deficit disorder, some people whose brains are easily distracted are [annoyed] at being labelled [and] will say that they are just high energy and creative; others will be thankful they were diagnosed, treated and had their attention span restored to almost normal.”

…it is not only companies who are to blame, but also physicians who diagnose a disorder and prescribe a drug, as well as patients who feel that they have a serious disease that needs treatment

Not surprisingly, the pharmaceutical industry does not buy the ‘disease mongering’ critique. “Our [industry’s] job is to look for cures, not to create disease. It’s up to the medical community to develop new diagnostic tools and ways to evaluate patient response,” said Alan Goldhammer, Associate Vice President for Regulatory Affairs for Pharmaceutical Research and Manufacturers of America (PhRMA), an industry trade group based in Washington, DC, USA. He maintains that drug regulators, such as the FDA, approve drug therapies on the basis of clinical trials. “One can argue you can’t do a clinical trial because if it’s not a disease, it’s unethical to treat people with a drug if you’re not going to come up with any potential benefits. There are a number of checks and balances throughout the development process that are totally external to the pharmaceutical companies.”

Critics maintain that it is not only the pharmaceutical industry that has a role in the creation of new diseases, although they certainly fuel the process. For this reason, Australian journalist Ray Moynihan, a visiting editor at the British Medical Journal and co-author of the forthcoming book Selling Disease: How Drug Companies are Turning Us All into Patients, describes the process as ‘corporate-sponsored drug creation’ because it also involves physicians and patient groups. “There are informal alliances of doctors, drug companies and increasingly patient groups that help to widen the boundaries of illness in order to widen markets for those selling treatments. Often this process is driven by the medical profession, but it’s driven with fuel provided by the drug companies,” he said. Nevertheless, drug companies have an important role in the process. “The meetings where these disorders are defined and expanded are all drug-company funded,” Moynihan said. “Drug company activity lubricates this process, but it’s often not corporate executives in the driving seat. Often it’s the so-called thought leaders at the top of the tree in their profession and in their specialties.”

Furthermore, it is not always obvious where the border should be defined between a mild symptom and a disorder that needs medical attention. “I wouldn’t draw such a clean line between manufactured and real diseases,” said Joe Dumit, Associate Professor of the Anthropology and Science-technology Studies’ Programme at the Massachusetts Institute of Technology (Cambridge, MA, USA). He has been studying the topic of disease creation as part of his work on how patients with controversial sociomedical conditions, such as chronic fatigue syndrome, Gulf War syndrome and multiple chemical sensitivity, organized themselves to obtain research funding from the US National Institutes of Health. Dumit found that when patient groups were backed by pharmaceutical companies, such as patients with ADD and post-traumatic stress disorder (PTSD), the character of the debate changed entirely. “When Zoloft [®; sertraline hydrochloride] was approved [in 1999 for PTSD], almost every article that came out about PTSD now more or less no longer questioned the existence of the disease, but instead talked about the treatment and whether [PTSD is] underdiagnosed or overmedicated,” he said. In addition to forming alliances with patient groups, drug companies also attempt to “maximize the detectable prevalence of conditions as part of the economic rationale for growing the market for the medications,” said Dumit. “Once you decide on a threshold like a cholesterol level or an amount of irritation in your bowels, and once you decide there’s a drug that could reduce that in a population, they have a strong incentive to market to that whole population.”

One such example is social anxiety disorder, better known as shyness. GlaxoSmithKline (Uxbridge, UK) had the indications for its antidepressant Paxil® (paroxetine hydrochloride) extended to treat social anxiety disorder, an extreme form of shyness marked by fear of public speaking, eating in front of others or using public bathrooms. The FDA approved this new indication in October 2003. However, “shyness is a new disease invented by Glaxo,” said Sidney Wolfe, executive director of the Public Citizen’s Health Research Group (Washington, DC, USA). “In a pathological way I’m sure that people are so shy it can be a disease. It can be a real downside for people. A lot of these people are depressed. A number of these people are shy because they have been physically or sexually abused when they were younger. Shyness is generally a symptom of something else and to gloss over finding the cause and to just throw a drug at someone is doing a disservice.” GlaxoSmithKline did not respond to a request for an interview.

In the end, it is not only companies who are to blame, but also physicians who diagnose a disorder and prescribe a drug, as well as patients who feel that they have a serious disease that needs treatment. “What you have in social anxiety disorder is senior clinicians who are often connected with [several] different drug companies promoting this almost as a horrifying psychiatric disease,” Moynihan explained. He therefore lays some blame on the medical profession if they are not forthcoming about these connections. “I just don’t think you can be credible when you’re taking money from drug companies. And often when these [experts] are communicating with the public, the public does not know of those ties,” Moynihan said. “This is the marketing of fear. This is not a healthy way to run a society. It’s putting disease at the centre of human life.”

The USA is the epicentre for both drug and drug-marketing innovation. In addition, it is the only developed country apart from New Zealand that allows direct-to-consumer advertising for medications. According to Moynihan, consumers are exposed to an average of ten drug advertisements per day on news programmes, sitcoms and soap operas, which has a major impact on their view of disease. “The drug ads are changing perceptions of human ailments and conditions and experiences,” he said. Referring to the process in which disease prevalence is maximized, Moynihan cited GlaxoSmithKline’s campaign to market Paxil in the late 1990s, when pamphlets were distributed suggesting that one in eight Americans had social anxiety disorder. “One in eight Americans! This is clearly an absurd fiction. The point of that is to try and make ordinary people feel sick,” Moynihan said.

It’s not healthy for children or adults to sit in front of a wall of drug-company promotion every day that tells healthy people they’re sick.

Although other developed countries may not have direct-to-consumer advertising, they are not immune to the influence of marketing campaigns. “This is a global phenomenon,” Moynihan said. “In other countries, you can’t advertise drugs direct to the public, but you can run and sponsor disease awareness campaigns and that’s what they see in Europe and Australia.” In fact, in the autumn of 2003, Germany’s largest weekly news magazine Der Spiegel devoted a cover story on the topic, based on German science journalist Jörg Blech’s book Die Krankheitserfinder (The inventors of disease), which analyses how the pharmaceutical industry invents new diseases to increase sales of their drugs.

Jerry Avorn, a medical professor at Harvard University and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at the Brigham and Women’s Hospital (Boston, MA, USA), is a long-time critic of the drug industry’s marketing practices. However, he is also sceptical of the social critics: “The reason we’re not still using leeches is we base our decisions about drugs on well done clinical trials of what works and what doesn’t. Nothing that comes out of the realms of anthropology or philosophy matters much if the science isn’t taken into account.” According to Avorn, there are two extremes in the discussion: those who overpromote the pill-for-every-ill philosophy and nihilists who view diseases as being invented. “The truth is somewhere in the middle,” he said.

Faced with increasing costs for healthcare services to cover drug prescriptions, politicians have also begun to investigate the issue of disease mongering. In 2004 and 2005, the British House of Commons held hearings on practices of the pharmaceutical industry, including disease mongering. In March 2005, the House of Commons Health Committee published a report, The Influence of the Pharmaceutical Industry, in which it expressed concerns about the effects of “medicalisation of our society—the pill for every problem.” The committee did not blame this trend solely on the pharmaceutical industry, but rather said the industry has encouraged it by acting as a “’disease monger’, with the aim of categorising an increasing number of individuals as ‘abnormal’ and thereby requiring (drug) treatment. This process has lead to an unhealthy over-reliance on, and an overuse of, medicines. It also diverts resources and priorities from more significant disease and health problems” (House of Commons, 2005).

To increase people’s awareness of disease mongering, Moynihan called for “a more robust conversation” on regulation. “The disease-awareness campaigns need to be seriously regulated. It’s not healthy for children or adults to sit in front of a wall of drug-company promotion every day that tells healthy people they’re sick,” he said. “I actually think quite strongly that there must be a conversation about how or if to regulate this. I think that’s extremely unlikely [in the USA] in the near future. I think the Europeans are a little more civilized about this stuff. And in fact the Europeans recently rejected loosening the rules on advertising.” As governments and public healthcare systems are increasingly confronted with the high cost of medications, no doubt the issue of medicalization and disease mongering will become even more important in future debates.Go to:

References

  • Breitstein J (2004) The making of a new disease. Pharma Exec 1 Jan, www.pharmexec.com [Google Scholar]
  • House of Commons (2005) The Influence of the Pharmaceutical Industry. Fourth Report of Session 2004–2005, HC 42-I. London, UK: The Stationery Office Limited [Google Scholar]

This interesting article from the health care industry discusses the huge push of the pharmaceutical industry to create disease and prescribe drugs motivated by profit. What medicines / drugs do you take? Why? How did you obtain the disease to require the medication?

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Dealing with disruptive physicians

Shidonna Raven Garden and Cook

INSIGHT ARTICLE – MAY 1, 2016

Source: MGMA
Featured Photo Source: Unsplash, Bill Oxford
Judith Holmes ESQ.
Leigh Olson

Effective practice administrators accomplish a great deal without blinking but many struggle with how to deal with disruptive physicians, a topic of conversation for at least 30 years, according to a Journal of the American Medical Association (JAMA) article. When disruptive physicians cause problems, everyone comes to the administrator expecting a perfect resolution to the problem. Here are four common situations that illustrate that point:

  • A young female physician says that a physician in the group made degrading, insulting comments to her and regularly calls her “Ms.” instead of “Doctor.”
  • A staff member threatens to quit because a physician has harassed her for months, telling inappropriate jokes, making suggestive sexual comments and touching her inappropriately.
  • A nurse practitioner reports that a physician has repeatedly yelled at her, thrown a chart at her and frequently berates her in front of patients.
  • A physician refuses to attend mandatory practice group meetings and argues with other physicians. She is chronically late, which leads to waiting room backups and angry patients.

The American Medical Association (AMA) defines disruptive behavior as personal conduct, whether verbal or physical, that negatively affects or that potentially may negatively affect patient care. This includes but is not limited to conduct that interferes with one’s ability to work with other members of the healthcare team. However, criticism that is offered in good faith with the aim of improving patient care should not be construed as disruptive behavior.

These situations all involve inappropriate, disruptive behavior as well as a power disparity, especially if the practice administrator works for the physician, which makes it difficult to resolve the problem. Even seasoned administrators find it difficult to resolve situations involving powerful, influential physicians whose behavior adversely affects the practice. These individuals are often intimidating and not accustomed to being questioned. They are rarely open to accepting criticism about their conduct and less receptive to requests for behavior modification. As a result, bad behavior might have been tolerated for years, which has caused low morale and high staff turnover.

Tolerating inappropriate behavior can increase the likelihood your practice will be sued or that a charge will be filed with the Equal Employment Opportunity Commission (EEOC). In 2015, the EEOC reported more than 89,000 claims had been filed against employers by employees for allegations of harassment, discrimination and retaliation.

Protecting the practice

If bad behavior goes unchecked, it can jeopardize the future of a practice. Here are some steps administrative leaders can take to protect their practices before disruptive physicians cause significant or irreparable damage to the practice:

CONFRONT THE PROBLEM.

Dr. Disruptive (Dr. D) just berated a staff member in front of a patient and several employees. This is the third instance of his uncontrolled anger in the past month. Two valued employees have now threatened to quit if they are the target of one more outburst. What should you do?

Ignoring complaints, which might be tempting, will likely lead to more bad behavior and potential legal liability. A head-in-the-sand approach is particularly damaging when a physician or staff member reports behavior to you and expects a response or some type of change. If there is no improvement in a physician’s behavior, you might lose good staff members and the culture of bad behavior will become more entrenched.

Your first step should be to assure your valued staff members that you take the complaint seriously, that you will investigate the concerns and, if appropriate, you will take steps to ensure remedial measures are taken to prevent recurrence of the conduct. Take comprehensive factual notes regarding the complaints or ask the employee to submit the complaint in writing. Offer to keep the complaint as confidential as possible, assure the employee that there will be no retaliation for reporting the incidents and request that the employee advise you immediately if he or she believes there have been retaliatory actions by Dr. D or anyone else.

Your second step is to determine the most effective way to confront Dr. D about his behavior. You can discuss the problem but this alone will likely not solve the problem, and the confrontation might have a lasting adverse effect on your relationship with the physician. Frequently disruptive physicians become defensive when confronted and believe they are not responsible for the outburst or other offensive conduct. Many times, a disruptive physician isn’t aware of the effect he or she has on colleagues and staff members, and might resent you for pointing out a personal fault he or she doesn’t want to recognize. If Dr. D is defensive or unaware of his effect on others, he will simply reject what you say and add you to his list of adversaries. You will have gained little and jeopardized your ability to communicate effectively with Dr. D in the future.

ENLIST HELP.

Once you recognize the necessity of confronting Dr. D about his disruptive behavior, seek assistance. If your group does not have an executive committee with an established procedure in place for addressing disruptive physicians, you will need to partner with at least one other influential physician in the group who shares your concerns and is willing to support your efforts to confront the issue and act as a liaison between Dr. D and the group. That individual should be able to be objective, so he or she should not be a personal friend of Dr. D and should not be an individual Dr. D perceives as an adversary.

Once the physician/liaison has been selected, convey the facts, discuss the likely outcome of failing to alleviate the problem and suggest ways the two of you can approach Dr. D to maximize the chance of a positive outcome. Although every situation is different and requires a unique approach, here are some suggestions for conducting a successful meeting:

  • Empower your physician/liaison to speak on behalf of the practice. When the meeting with Dr. D is scheduled, it should be clear that the liaison has the authority to speak on behalf of the practice.
  • Prepare an outline of points you want to cover. Stick to a script so you avoid getting pulled into an argument. Have copies of your code of conduct and any written policies and rules that apply to the situation.
  • Conduct the meeting in a private, comfortable, professional setting. Reduce the tension as much as possible to encourage a positive dialogue. Do everything possible to make this a problem-solving experience.
  • Explain the problem behavior to Dr. D in factual terms. Describe the sequence of events and discuss the effect Dr. D’s behavior had on staff and the potential adverse effects his actions had on his professional reputation and the reputation of the group.
  • Refrain from using emotional terms such as bad behavior, tirade or childish tantrum to describe the conduct. These terms might describe the conduct but can polarize the situation and make Dr. D more defensive.
  • Give Dr. D the opportunity to explain the situation in his own words. Chances are he will not take responsibility for his behavior or might blame staff incompetence for an outburst. He may attempt to change the subject and begin listing the ways the group is at fault for mistreating him. Don’t take the bait. Insist those grievances be taken up at a different time and remind Dr. D that the purpose of the meeting is to address his conduct on specific dates.
  • Ask for Dr. D’s input on how past situations could have been handled differently to avoid the incidents that gave rise to complaints. Make it clear that there is never a valid reason for treating staff members disrespectfully.
  • When discussing Dr. D’s conduct, consider whether the outbursts may be a result of a drug or alcohol problem or whether his conduct could be the result of mental illness, such as depression. If there is some indication that Dr. D’s conduct is a result of one of these issues, it might be appropriate to refrain from taking any action until you consult with the executive committee and act in accordance with your substance abuse policy.
  • Advise Dr. D that you will be drafting a performance improvement plan (PIP) that will require him to make immediate, permanent changes in his behavior. Make it clear that failure to comply with the terms may result in discipline, up to and including termination. The PIP should include objective, measurable and achievable goals designed to prevent disruptive behavior in the future.
  • Make it very clear to Dr. D that no retaliation of any kind will be tolerated. If you have a written retaliation policy, be prepared to give Dr. D a copy at the end of the meeting.
  • Carefully document what occurred and what was discussed during the meeting.
  • Follow through. If you put Dr. D on a PIP, monitor his behavior and respond quickly and appropriately if requirements are not met.

This type of approach is not appropriate for every situation. Some situations require immediate action. For example, if disruptive behavior involves threats, violence or sexual harassment, the practice must act promptly to remedy the problem.

DEVELOP A PREVENTION PLAN.

If a group has tolerated disruptive behavior for years, you won’t change the culture overnight. However, you can implement policies and protocols that will help protect your practice in the long run. Those policies should be assembled in a physician handbook and include policies that:

  • Prohibit unlawful harassment that includes a clear statement that your group strictly prohibits sexual harassment as well as harassment on the basis of race, color, gender, religion, disability and all other categories protected by federal and state law. The policy should define harassment and give examples of unacceptable behavior.     
  • Prohibit discrimination on the basis of any protected category. This is helpful when addressing a situation in which a disruptive physician refuses to work with a colleague because of gender, religion, ethnicity, etc.
  • Define unacceptable behavior. This physician discipline policy should also include a step-by-step procedure the group will use to investigate complaints.
  • Prohibit retaliation against any employee to ensure that when staff members or physicians make complaints about a disruptive physician, they are protected from any retaliatory conduct.
  • Prohibit workplace violence that includes a description of prohibited conduct as well as a clear statement that violence or threats of violence must be reported.
  • Address the issue of impaired physicians that will be used to assess and address this very complex issue. The procedure might include a multistep plan for board intervention, mandatory leave and/or referral to an appropriate rehabilitation or mental health program. It should also include clear consequences for failure to rectify impairment issues within a reasonable time period.

Many practices take the time and effort to develop behavior standards but do not take the extra step to make the policies an integral part of their management and discipline strategies. Incorporate behavior standards into a comprehensive physician handbook. Once you have implemented behavior policies, be sure to train every physician on what those policies mean and how they will be enforced, and then apply those policies consistently. It is a time-consuming effort, but if the group is guided by the policies contained in your handbook, your practice management will get much easier.Coming in the August issue: Learn how to curb disruptive conduct, establish a code of conduct and use physician contract provisions to reward good behavior and discourage bad behavior. We will also examine conflict resolution techniques that will help you resolve personality disputes that lead to disruptive behavior.

How are patients impacted by these inappropriate behaviors? Have you ever seen these behaviors in your doctors? What should be done for patients?

Share your comments with the community by posting them below. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep sharing!

If these articles have been helpful to you and yours, give a donation to Shidonna Raven Garden and Cook Ezine today. All Rights Reserved – Shidonna Raven (c) 2025 – Garden & Cook.

ABOUT THE AUTHORS

Judith Holmes

Judith HolmesESQ.

PrincipalMaster Series Seminars, LLC.Leigh Olson

Leigh Olson

PrincipalMaster Series Seminars, LLC.