FDA Public Hearing on Promotion of Medical
November 12, 2009
I am pleased to have the opportunity to testify as president of the National Research Center for Women & Families.
Our Center is dedicated to improving the health and safety of adults and children, and we do that by scrutinizing medical and scientific research to determine what is known and not known about specific treatments. We do not accept contributions from companies that make medical products.
In addition, I am a fellow at the University of Pennsylvania Center for Bioethics. I was previously on the faculty at Yale and Vassar, conducted research at Harvard, and I have worked on federal health policy issues in Congress, the White House, the Institute of Medicine, and for nonprofit organizations for the last 25 years.
I want to start by saying that I think it is unfortunate that the timing and structure of this week’s meeting made it impossible for many nonprofit organizations to participate. Those of us who are here know that our concerns are shared by many other public health, patient, and consumer organizations. However, most do not have the staff or resources to set aside two days of unscheduled time for a meeting, especially non-reimbursed time, and especially in the middle of the health care reform negotiations. They would have been here if they could have. I’d like to make a few points, and then spend a few minutes talking about Wikipedia as a popular source of information on medical products.
- 1. Direct to consumer advertising is persuasion, not information. Every year, millions of Americans are persuaded that they need medications they have seen advertised – and many of those Americans have limited understanding of the likely benefits or possible risks of those medications. DTC regulations need to be improved and enforced, and those regulations should be the minimum requirement for ads on the Internet and other media.
2. In TV, radio, and magazine ads, every piece of information costs a lot of money to include. That isn’t true for the Internet, smart phones, or other digital hardware. FDA should demand much better information about risks in all media, but especially the Internet and other new media. Risk information and other caveats about safety or effectiveness should be as prominent and persuasive as the information about benefits. It should be as accessible – not hidden behind or below the more positive promotional information-and should not require clicking other links. One click away is one click too many. If the information about benefits doesn’t require a click, the information about risks shouldn’t require a click either.
3. Companies should be held responsible for the accuracy and balance of all information about their product that appears to be promotional, regardless of the ostensible source of that information. That is necessary because so much information in blogs, patient Web sites, and other “third party” sources is bought and paid for, directly or indirectly, by the companies whose products are being praised. Latisse is a good example of a product that is widely promoted on the Web, in articles where it is unclear whether the author is or isn’t associated with the company that makes the product. Latisse is a medical device that treats the tragedy of thin eye lashes, but it has risks, including changing one or both of a person’s blue eyes to brown. Many of us would like longer, thicker eye lashes, but we don’t want our eye color to change, and we especially don’t want the color of just one eye to change. That risk information should be clearly stated on any Web site, but it isn’t. If a company says it is not responsible for the content of a blog or Web site that praises its product in a biased or inaccurate way, the company should be required to request corrections and, if unsuccessful, prove to the FDA that it is not responsible for the content. Penalties should be substantial for companies that pay for any promotional materials that are biased or inaccurate.
4. Some have suggested an electronic FDA logo or other type of FDA seal of approval for Web content that is consistent with FDA approved labels or other FDA content. There are at least two problems with that idea:
#1. Content can be identical but incomplete. For example, a Web site can include exact wording about benefits but incomplete information about risks.
#2. Content can be identical to FDA’s approved information today but can be inaccurate tomorrow or next week, if the label changes.
For example, if you look up Vytorin on drugs.com, it has accurate information about risks and benefits, but fails to mention a caveat that the FDA has required on the company’s Web site: a statement that says:
VYTORIN contains two cholesterol medicines, Zetia (ezetimibe) and Zocor (simvastatin), in a single tablet.VYTORIN has not been shown to reduce heart attacks or strokes more than Zocor alone.
If you type “Vytorin” in google, Drugs.com is the first Web address that comes up, so it is a very widely used source of information. I don’t know why drugs.com doesn’t include that crucial caveat, but it isn’t because they don’t know about it. In fact, I sent an email to drugs.com a few days ago to ask about it. They have not responded to me, nor have they added the statement on their Web article. I don’t want to pick on drugs.com. I don’t know who pays them or who makes decisions about what is on their Web site. And, this is a problem on other web sites, not just drugs.com. But the fact that Vytorin is not more effective than a drug with half the ingredients and half the risks is important and should be included on all Web sites.
- 5. In contrast to the FDA seal of approval idea, we like the idea of requiring a direct link to FDA’s online content on a medical product for any Web site that is owned by or supported with funds from the manufacturer. The link should be in a very noticeable location, and would NOT take the place of balanced, accurate information.
6. Limitations are needed to restrict ads on email, text messaging, and social networking sites. We agree with Consumers Union, which is testifying tomorrow, that drug or device companies should not be permitted to promote their products via email, text messaging to consumers, chat rooms, or social networking bulletin boards.
I’d now like to say a few words about Wikipedia. Our Center has quite a bit of experience with Wikipedia, some very good, some very bad. Anybody can create an article on Wikipedia, and anyone can edit an article on Wikipedia. It’s a very egalitarian system in terms of the rules: a middle school student can edit the Wikipedia contributions of a Harvard professor and vice versa. If there are disagreements, they are usually resolved by volunteers called “administrators,” who often have little knowledge of the specific information involved.
It is against the Wikipedia rules for companies to promote themselves, and in fact even the most altruistic nonprofit organization is not supposed to promote itself – but the reality is very different. While Wikipedia does not discriminate against people on the basis of age or education level, it does discriminate on the basis of how much time you spend on Wikipedia. If someone were to go on Wikipedia to write one article praising one product, a Wikipedia monitor or administrator would likely notice it and assume that person was from the company that makes the product, and might delete the article. However, if someone were to spend a few hours a week editing a lot of articles, and wasn’t only adding information praising one company’s product, this person would probably get away with just about anything he wanted to say about specific products, even if he were from the company that made the product, or were paid by that company. Wikipedia editors would be unlikely to notice.
As a result, Wikipedia articles about prescription drugs and medical devices vary greatly in balance and quality. I noticed this week that articles on many anti-psychotic medications, for example, are very balanced – more so than articles on drugs.com and other popular Web sites. However, Wikipedia articles on some FDA-regulated medical products read like promotional literature. For example, the Wikipedia article on NeuroStar, a device used for the treatment of depression, is definitely written by someone who loves the product, and probably by someone tied to the company that makes the product. The Wikipedia article on breast implants is similarly promotional in nature, and when researchers attempted to add warning information from published peer-reviewed articles or the FDA Web site, it was immediately deleted by a man who said on a Wikipedia discussion page that he was a plastic surgeon and knew more than the FDA or others who disagreed with him. I don’t know if the man really was a plastic surgeon, I don’t know if he was paid by an implant company, but I can tell you that he spent hours each day fixing that Wikipedia article by deleting risk information and adding promotional information. That would be a very unusual activity for a physician. Regardless, the result is that an article about a medical device is providing very biased information and Wikipedia administrators who were involved in the debate made the decision to support the promotional bias of the article.
Wikipedia is a major source of information for millions of people around the globe. Wikipedia articles on medical products rank high on google and other search engines. It would be extremely time-consuming for FDA to monitor all relevant Wikipedia articles, but I strongly suggest that the agency reach out to Wikipedia officials to develop a process that can maximize the accuracy of articles about FDA-regulated medical products.
To do that, and to ensure the balance and accuracy of ads on the Internet and “new media” will require substantially more resources for the FDA. Realistically, that money will need to come from new industry user fees. We will join Consumers Union and other consumer groups to advocate for that as part of the PDUFA 5 negotiations next year.
Thanks for the opportunity to comment on these very important issues.