FDA Tapped Pharma Consultant For DTC Web Site
7 CommentsBy Ed Silverman // September 15th, 2008 // 9:37 am
The agency hired a non-profit that is run by Michael Shaw, an advertising consultant to the pharmaceutical industry, to help design a new consumer campaign about direct-to-consumer advertising, Integrity in Science Watch reports. (Here is the press release).
The FDA’s new website, “Be Smart About Prescription Drug Advertising: A Guide for Consumers,” was developed by EthicAd, a non-profit based in Atlanta that, on its web site, claims to be independent and does not accept industry funding. However, ISW notes the organization is based in the same offices as Shaw Science Partners. The client list includes many familiar big pharma names and the site takes credit for helping to launch numerous drugs, including Viagra, Celebrex, Zoloft, Abilify and Avastin.
The new FDA, which claims DTC advertising “can provide useful information to consumers,” contains examples of legally correct and incorrect ads. ISW contends the info is “more useful to ad designers who wish to avoid running afoul of FDA regulations than to consumers.” But consumers are encouraged to report violations the FDA’s division of Drug Marketing, Advertising and Communication.
Shaw, EthicAd’s executive director, is identified on EthicAd’s website only as a former medical advisor to the National Library of Medicine at the National Institutes of Health, a post he held for three years nearly three decades ago, according to ISW. A loophole in Georgia law allows non-profits to incorporate in the state without registering with the IRS, so financial records for EthicAd are not publicly available, ISW reports, adding that Shaw Science Partners reported $1.6 million in revenue in 2006, citing data from manta.com.
In an interview with Integrity in Science Watch, Shaw admitted his firm and other members of EthicAd’s board underwrite the group’s expenses, which enables it to donate its services to the FDA. “All members do work for industry; if not all, almost all,” Shaw tells ISW.
EthicAd’s ‘leadership’ includes general counsel Marc Scheineson, a former FDA official who is general counsel for EthicAd and a partner at Alston & Bird, a Washington lobbying firm with pharma clients; and steering committee members Laura Benson, director of communications at OSI Pharmaceuticals and John Greist, director of Healthcare Technology Systems, which serves the drug industry.
Others include Michael Jenike, a professor of psychiatry at Harvard Medical School; Sheldon Preskorn, a professor of psychiatry at the University of Kansas School of Medicine; Michael Weber, a professor of medicine at New York Downstate Medical Center in Brooklyn; and Henry Black, a professor of internal medicine at New York University School of Medicine, each of whom has received either research funding or consulting fees from multiple pharmaceutical firms, ISW reports.
Jim Parker
FDA laws are creating a lot of awareness amongst the consumers and the best part is that some big pharmacy names are with them to save some life savings drugs.
Lisa Van S
Psychiatry;.. Now why doesnt this surprise me!
Justice in Michigan
This could be useful or, to use a currently popular metaphor, lipstick on a pig.
We will see what content shows up. for example, will the difference between absolute and relative risk or benefit be clearly explained? Will it made clear that advertising is advertising (for anyone who doesn’t quite understand)? And much more.
A useful site, in my view, would be one that helps consumers “translate” ads into what is genuine information and what is hype. But is there any chance that this site would do that?
Chris
JiM-
You would be very surprised about the percentage of physicians who ‘fall’ for this as well (absolute vs relative risk). This marketing technique is useful for persuading physicians as well as consumers.
Joana Ramos
Comments on 2 different themes in this article:
To learn about evaluation and deconstruction of genuine pharma ads, everyone is welcome to visit Health Skepticism’s Ad Watch, at: http://www.healthyskepticism.org
RE:
“A loophole in Georgia law allows non-profits to incorporate in the state without registering with the IRS, so financial records for EthicAd are not publicly available…”
While I couldn’t agree more that nonprofit transparency & accountability are of the utmost importance, just the fact that a nonprofit is not registered with the IRS does not necessarily mean that it’s operations are unethical , plus the state incorporation process for nonprofit organizations and the federal process for obtaining IRS status as a tax-exempt charitable organization are two completely separate matters.
State-level issues:
Each state regulates (or not) charities operating within its borders, and is free to set its own rules; oversight varies greatly. While I am not familiar with GA laws, the rules in my home state of WA are an example. Nonprofits can incorporate under WA law via the Corporations Division of the Secretary of State; they will then need to file a basic annual report with financials. In WA, the public can view report basics online, and purchase each report for $5. WA requires all charities soliciting donations from the public to obtain a Charitable Solicitation License. But if a nonprofit is all-volunteer run, has annual revenues of less than $10,000, and does not use commercial fundraisers, it can be registered as a charity and receive an official exemption from needing a CSL, and still do its own fundraising. However, the budget of the WA AG’s Charities Division has been drastically reduced for over 10 years now, so it’s oversight capacity is quite limited. This is true in many other states as well.
Federal-level issues
Charities whose revenues are under $25,000 per year are not required to obtain federal 501(c)3 tax-exempt status, or to seek classification under any of the 501(c) categories. Until this year,such small charities were also not required to file any reports with the IRS. In addition, it might not be possible to to view the Form 990 ( the annual financial report required by the IRS form tax-exempt organizations; it is not a tax return b/c these groups don’t pay taxes) of new charities who do have 501(c)3 status, simply due to to IRS processing time. Nonprofits that do file a Form 990s must make them available to the public, and the forms can viewed on Guidestar, at http://www.guidestar.org.
Starting in 2008– for FY 2007–almost all independent charities, no matter what their size, revenues, and regardless whether or not they hold 501(c)3 status, must file a brief annual report with the IRS called 990-N or e-postcard. This is supposed to be the start of creating more oversight. Also, Form 990 has now been greatly revised, so that it will include much more programmatic and governance data. These changes came about due to ethical concerns, including the creation of 501(c)3 groups simply to serve as tax shelters, not for the charitable purposes intended by the law.
Also, the IRS has not been free from blame in the situation. The field of nonprofit management is so large & complex, I can’t get into anything more here. There are many excellent resources out there, on the web and in many communities.
Joana
Justice in MI
Rereading the article, I am intrigued by the piece about consumers reporting suspected ad violations to DDMAC.
Over the past few years, I have reported a couple of very serious violations to DDMAC. I never heard anything from them, even after attempts at follow-up contact. Nor did the promotional tactics in question change.
So I am beginning to feel some regret. I might very well owe an apology to pigs.
GMP guide for pharmaceuticals
This is a good step by FDA as this will realy take a controll over ADS which are not in intrests of public