The Lexapro Marketing Plan Was Meant to Promote Marketing (Surprise?)

Last week, Gardiner Harris writing for the NY Times noted that the US Senate Special Committee on Aging had made public part of Forest Laboratories' Fiscal Year 2004 Marketing Plan for the drug Lexapro (escitalopram oxalate), an anti-depressant. The document is available here.

Review of this plan revealed the marketing department's various activities, including activities that others might have believed were educational, scientific, or had some other high minded purpose.

Continuing Medical Education

Overall, one "promotional objective" was to "Maintain SRI category leadership in total number of medical education events (including CME symposia, speaker promotion, teleconferences, and peer selling programs)"

One "critical issue" was to "increase Med Ed efforts: more sponsorships of CME, increased level of speaker programs, maintain level of teleconferences and peer selling."

Under "Marketing Tactics" was a long section on "Continuing Medical Education." It covered various venues for CME such as internet/electronic CME, "sponsoring symposia at major meetings," "regional CME symposia" which would "serve a number of medical specialties," "sponsorhips of scientific sessions," etc

Production of Scholarly Articles

The "Publications" section of "Marketing Tactics" noted "publications will be geared toward psychiatrists, PCPs, .... Articles will appear in several formats, including original reports, review articles, and journal supplements."

Thought Leaders and Consultants

Under the "Continuing Medical Education" section of "Marketing Tactics," and then in the "Advisor Relations" section, there were numerous references to what "thought leaders" would do, including
- "present new data" at "symposia at major meetings"
- act "as advisors to Lexapro in order to obtain critical feedback and recommendations on educational and promotional strategies and tactics."
- sit on the "Lexapro Exectuive Advisory Board" to "keep our advisors apprised of the commercial development ... of escitalpram."
- sit on the "Primary Care Advisory Board" to "obtain critical feedback and recommendations on educational and promotional strategies and tactics...."

Role of Medical Centers

Under the CME section of "Marketing Tactics," we see that "academic health centers" would help develop "regional CME symposia."

Under the "Sponsorship" section are plans to fund the "Professional Relations Group in their mission of establishing mutually beneficial long-term relationships with appropriate professionals and associations." Specific plans included funding the Department of Psychiatry and Behavioral Sciences at Emory

Medical Societies

The "Sponsorship section" also noted that these relationships "will also provide the basis for advocacy development and issues management, and will establish an appropriate environment for commercial and policy activities."

Under the CME section of "Marketing Tactics, we see that "medical associations and professional societies" would help develop "regional CME symposia" Also in this section is the note that "smaller, more prestigious societis do not accept industry-sponsored symposia." So instead, "sponsorship of a study groups or plenary sessions is recommended. Marketing will work with the professional relations group regarding potential opportunities."

Appendix VII, "Professional Associations of Priority" noted funding provided for guideline development by a "collaboration between APA, AAFP and ACP" for "chronic depression in primary care practice;" by AAGP for guidelines for late-life depression; multiple guidelines developed by AMDA;

The appendix also noted that Forest supports ACNP "annual programming, and is a founding sponsor of it's newly created International College of Geriatric Pscyhopharmacology (ICGP)," is a "Corporate President's Circle Sponsor of AAFP," became a "corporate sponsor of ACP in FY03," became "a Corporate Sponsor of AMDA for the last few years,"

Also, it noted that Forest has "expanded its involvement" with APA for "lobbying of State Health Departments...."

Disease Advocacy Organizations

Also in Appendix VII, Forest was identified as a "Corporate Sponsor of NAMI," a "major Corporate Sponsor of NMHA," and a "major Corporate Sponsor of DBSA."

Summary

We have often heard from pharmaceutical, biotechnology, device and other health care corporations that they are only involved in education to disseminate accurate information for the good of society. We have often heard from physicians and academics who consult for such corporations that their advice is sought about clinical, scientific, and technical issues. We often hear from academic medical institutions, medical associations and disease advocacy groups that the money they get from such corporations does not influence the content of their educational and scientific work.

Yet here we see, in considerable detail, that in the case of one drug company's promotional efforts for one drug,
- The marketing plan from the marketing department paid for medical education as a "promotional objective," that is, to market, not to educate.
- Thought leaders and consultants were again paid by marketing to market, and sometimes to provide opinions about "promotional strategies" and "commercial development."
- Medical associations are funded by marketing "for commercial and policy activities."

This suggests that health care corporations develop financial relationships with physicians, academics, academic institutions, medical and professional associations, and disease advocacy groups to support marketing first.

This allows the corporations to advance marketing disguised as education, research, and other high-minded and apparently selfless activities by professionals, not-for-profit organizations, and dedicated inviduals. Such marketing, of course, is DECEPTIVE and DISHONEST. It also is in conflict with the professionals' ideals, and the missions of the medical and professional assocations and disease advocacy groups.

The physicians, other health care professionals, and not-for-profit organizational leaders involved may rationalize these activities as consistent with their mission and professionalism, but such rationalizations are at best self-delusion.

No one knows how representative the Lexapro marketing plans are of the marketing of other drugs, devices and health care services. The only way to find out would be to force many other corporations' marketing plans into public view. The Lexapro documents suggest that society would benefit if many more marketing plans were made public, but that such publication might generate a wave of revulsion about how deceptive marketing of health care goods and services has become, and the extent that health care professionals have betrayed their professional ideals, and academic medical institutions, professional and medical societies, and patient advocacy groups have betrayed their missions.

I submit that we will not truly reform health care without making the marketing of health care goods and services honest, getting health care professionals to give up their financial relationships with health care corporations to reclaim their professionalism, and getting academic medical institutions, professional and medical societies, and patient advocacy groups to give up their financial relationships with health care corporations to reclaim their missions.

See additional comments on how the marketing plan was meant to promote CME by Dr Daniel Carlat on the Carlat Psychiatry Blog.

Post Title → The Lexapro Marketing Plan Was Meant to Promote Marketing (Surprise?)

Patient or Pharmaceutical Company Advocates?

We have previously blogged (here and here) about ties among pharmaceutical companies and patient advocacy groups.

The Boston Globe just reported how a patient advocacy group was entangled with the pharmaceutical industry. The story was about Elzora K Brown, founder of the Breast Cancer Resource Committee:

Elzora K. Brown could stand before a microphone and calmly describe the swath of devastation that cancer has cut through five generations of her family.

"My own story is replicated in the lives of high-risk families across the globe," Brown told an audience of Food and Drug Administration advisers considering a controversial application to allow wider sales of silicon gel breast implants....

Brown's message about the need to reduce disproportionately high mortality rates among African-American women, like herself, resonated whether she was testifying before the FDA, addressing the nation's mayors, or speaking with members of Congress, where she was a staff assistant to former US House Majority Leader Jim Wright.

Through speaking engagements for the Breast Cancer Resource Committee, a patient-advocacy group Brown founded in 1989 , she highlighted the benefits of early cancer screening, offered a support group for African-American women, and called attention to the need for diversity among participants in clinical trials for new treatments.

Patient advocates like Brown regularly testify at FDA public hearings, packing an emotional punch as advisers vote on controversial drug and device approvals.

Although Brown's committee billed itself as an organization for patient advocacy, it was heavily supported by pharmaceutical company funds, and Brown herself made quite a nice living running it.

What few in Brown's audiences knew is that the patient advocate personally profited from her cancer-survival message, accepting funding from major pharmaceutical companies that produce cancer treatments, according to tax records.

'As a survivor, I want a healthy life after breast cancer, so the long-term side effects of treatment must figure into the treatment decision,' Brown said in a press release touting Ellence (epirubicin), a breast cancer drug that showed lower heart risk. The release, distributed by Pfizer Inc., did not disclose the funding that Brown's group received that year from the drug giant.

From 1996 to 2004 , the years for which Internal Revenue Service records are available, the Breast Cancer Resource Committee raised about $3.4 million from mostly corporate donors, including hundreds of thousands of dollars from such drug firms as Amgen Inc. , AstraZeneca Pharmaceuticals LP , GlaxoSmithKline PLC, and Pfizer Inc. As her nonprofit's coffers swelled, Brown's salary jumped from $40,100 to $162,500 --roughly one-third of every dollar raised. During that time, the group paid up to $2,600 a month for a four-story Washington, D.C., townhouse, assessed at $788,510 , where Brown lived and worked. She also made liberal use of the committee's American Express card for 'incidental, personal expenses,' according to tax records, leaving the balance unpaid.

The nonprofit's accountant, James Dunn , of White Hall, Md ., declined to respond to questions about liens the IRS filed against Brown in 2003 , which allege she underpaid taxes by $179,257 from 1997 to 2002.

Brown's highest salary was in 2002 , when she was paid $162,500 and the organization raised $554,993 . Brown's salary would have ranked her among the highest-paid chief executives for nonprofit advocacy groups of that size, according to a 2005 compensation survey of 1,660 nonprofits. It compares with a median salary of $72,000 paid to chief executives of nonprofit advocacy organizations with annual revenue from $500,000 to $1 million , according to Abbott, Langer & Associates Inc. , a firm that conducts salary surveys.

In 2002 , Brown also was reimbursed $37,246 for expenses and tallied $2,682 in personal charges on the committee's American Express card, according to the IRS filing. By 2004 , that unpaid card balance was $4,414.

The behavior of some groups ostensibly advocating for patients has drawn criticism.

Public Citizen's Peter Lurie , who testifies frequently before FDA panels, noticed a shift as public hearings 'were becoming contaminated by people who didn't represent the public in any way. They represented particular moneyed interests.' Lurie, deputy director of the consumer advocacy organization's health research group, said, 'It's a fair question: Who represents patients and how they come to call themselves' patient representatives?

The Globe interviewed others who were specifically critical of Brown.

'In a vacuum, Elzora Brown's salary is, arguably, not outrageous,' said Thomas A. McLaughlin , a consultant at Grant Thornton LLP and author of 'Streetsmart Financial Basics for Nonprofit Managers,' which coaches nonprofit leaders on how to read and use financial data. 'What is far less defensible is the fact that she is paid nearly one-third of every dollar that comes through the door.'

'It's looking like this is her own piggy bank,' said Daniel Borochoff , president of the American Institute of Philanthropy , a charity watchdog based in Chicago. 'You need to separate business and personal expenses; that's a pretty common principle.'

When patient advocacy groups are heavily funded by pharmaceutical companies that make products likely to be used by the patients the groups advocate for, and when the leaders of these groups are very well recompensed out of these funds, one wonders whether the groups' allegiance are first with patients or with their pharmaceutical company sponsors. At least they should disclose their sources of support and let their audience decide for themselves.

Post Title → Patient or Pharmaceutical Company Advocates?

Donations tie drug firms and nonprofits

More on how pharmaceutical companies may be skewing the drug sales playing field through influence on the medical nonprofit specialty societies that are held in high regard by patients and clinicians alike:

Donations tie drug firms and nonprofits
By Thomas Ginsberg
Philadelphia Inquirer Staff Writer
Sun, May. 28, 2006
Many patient groups reveal few, if any, details on relationships with pharmaceutical donors.
The American Diabetes Association, a leading patient health group, privately enlisted an Eli Lilly & Co. executive to chart its growth strategy and write its slogan.

The National Alliance on Mental Illness, an outspoken patient advocate, lobbies for treatment programs that also benefit its drug-company donors.

The National Gaucher Foundation, a supporter of people suffering from a horrific rare disease, gets nearly all its revenue from one drugmaker, Genzyme Corp.

Although patients seldom know it, many patient groups and drug companies maintain close, multimillion-dollar relationships while disclosing limited or no details about the ties.

At a time when people are making more of their own health-care decisions, such coziness raises questions about the impartiality of groups that patients trust for unbiased information. It also poses a challenge for groups trying to hold patients' trust and still raise money to serve them. An Inquirer examination of six groups, each a leading advocate for patients in a disease area, found that the groups rarely disclose such ties when commenting or lobbying about donors' drugs. They also tend to be slower to publicize treatment problems than breakthroughs. And few openly questioned drug prices.

I agree with this assessment. While these groups perform an important function, especially in education and advice to patients, the covert involvement of industry in this sector seems inappropriate, even from the free-market viewpoint.

These organizations are not commercial and should not be used in any way as an avenue for increased drug advertising or "branding" with patients. The lack of disclosure mentioned in the Inquirer article is at the heart of the matter. Apologists who offer opinions that the money does not influence insiders at these organizations are deluding themselves.

Worse, the money seems to come not from R&D or the charitable arms of these drug companies but from marketing:

The donations are sometimes portrayed by the companies and nonprofits as "giving back" to patients. But the funding usually comes from the companies' marketing or sales divisions, not charity offices, company and nonprofit officials said. Grants often rise with promotional spending as a drug hits the market and fall when sales ebb.

Donations from Merck and Pfizer Inc. to the Arthritis Foundation more than doubled, to at least $1.65 million combined, in 2000 as they launched Vioxx and Celebrex. The donations fell below $375,000 by 2004, when safety fears had flattened sales, foundation reports show.

Merck explicitly wove the foundation into sales strategies. A 2001 internal memo, disclosed in product-liability trials, shows that Merck sought to use the foundation's pain-management program to "demonstrate additional benefits" of its products.

Practices like this at pharmas really teeter on the precipice of unethicality on the part of marketing. Merck, for example, had corporate values that asked employees to ask themselves "how would it appear in print?" as a step for evaluating the ethics of some planned action.

In this case, the Philadelphia Inquirer has just answered that question.

-- SS

Post Title → Donations tie drug firms and nonprofits

Strange Bedfellows: Pharmaceutical Companies and Identity Politics

The New York Times reported on the high costs of New York State's Medicaid program related to its payments for prescription drugs, with most surprising results.

The New York State Medicaid program until recently had virtually no cost controls on prescription drugs. Its spending on drugs had gone from $1.7 billion in 1999 to $3.8 billion in 2004. Between 2002 and 2004, it spent $157 million on the drug Nexium, esomeprazole (AstraZeneca), which is chemically very similar to, and has no clinical advantage over generic omeprazole. The program spent more on specific drugs than did programs in other states, for example, it paid $18.70 per cannister of generic albuterol, while the Texas program paid $6.63, and $3.67 per capsule of omeprazole, while California paid $1.44.

The Times noted that New York Governor Pataki, a conservative Republican, had sought various ways to control Medicaid spending on drugs. He asked to cut reimbursement rates to pharmacies for specific drugs, require prior authorization for specific drugs, and develop a preferred drug program. Opposing all these moves was the Democratic majority in the state legislature. According to the Times, "the most pivotal opponents to the [preferred drug] program were Hispanic lawmakers in the Democratic majority in the State Assembly, along with Hispanic advocacy groups, who wanted to retain an unlimited choice of drugs for Medicaid recipients. The Hispanic Federation, a coalition of health and social service agencies in the New York region, held repeated events in Albany to denounce the proposal, saying it endangered patients." "Assemblyman Peter M. Rivera, a Bronx Democrat and Chairman of the Assembly's Puerto Rican/Hispanic Taks Force, helped lead the opposition to the drug list." "Last spring, Mr. Rivera circulated a report among his colleagues saying that Hispanics as a group can react differently to drugs than others. As a result, the report said, pharmaceutical plans should cover a wide range of drugs because restricting them could force Hispanics to take some that are not appropriate for them."

Hold the phone, here. This is all very strange. A conservative Republican fighting to restrict payments for pharmaceuticals? Left-wing Hispanic Democrats leading the charge for practically unlimited spending on pharmaceuticals? None of this fits the usual US political mold.

The Times suggests some answers.

• One of the Board of Directors of the Hispanic Federation is Sylvia M. Montero, Senior Vice President, Human Resources at Pfizer Inc . "The federation has received contributions from Pfizer since the mid-1990s, including a $50,000 donation las year.... The group also receives contributions from other drug companies...."
• Assemblyman Rivera "has received more than $20,000 in campaign donations from drug company interests, among the highest total for state lawmakers." Although he asserted, "I am not doing this because I am in the pocket of the pharmaceutical companies. I am doing it because it's the right thing. The governor is trying to balance the budget on the backs of poor people."
• The report circulated by Mr. Rivera was written by the National Alliance for Hispanic Health, "an advocacy group in Washington that is heavily financed by pharmaceutical companies and has a corporate advisory board whose members are mostly pharmaceutical executives, according to the group's records. The alliance worked on the report with the National Pharmaceutical Council, a trade group of major pharmaceutical companies."
• "Overall, pharmaceutical companies and trade groups, including Pfizer, Merck, Bristol-Myers Squibb and Eli Lilly, are among the biggest contributors to state politicians in Albany. Since 2002, they have given roughly $2.5 million to New York candidates and committees 0n the state level, channeling most of it to the majorities in the State Assembly and Senate."
• "Pfizer, which fought the drug list most vigorously, gave about $300,000 in campaign contributions last year alone, up from $100,000 in 2002."

Big pharma companies seem to have spent considerable money and effort ingratiating themselves with people and organizations who promote the politics of ethnic identity. (This has occurred even though the interests of large corporations, including pharmaceutical corporations, stereotypically are linked to the right wing, and the promotion of ethnic identity is usually linked to the left wing, or at least the academic and cultural left.) And now those who promote the politics of ethnic identity seem to be promoting policies that benefit big pharma more obviously than they benefit their ethnic constituencies. Such policies, however, may be very costly to the public as a whole, siphoning off money that could be spent on health care for all, including the disadvantaged.
You really can't tell the players any more without a score card.

Post Title → Strange Bedfellows: Pharmaceutical Companies and Identity Politics