FDA and the Internet: Advertising and Promotion of Medical Products - Discussion Group 2
|VOLUME I:||Remarks||WWW 101||Group 1||Group 2||Presentations||Group 3|
|VOLUME II:||Remarks||Group 4||Presentations||Group 5|
October 16, 1996
DISCUSSION GROUP 2
Chat Rooms and News groups
Moderator: Linda Golodner
|Wendy Borow, Com-Med Interactive--Medicus New Media|
|Mark Boulding, Fox, Bennett and Turner
|Loren Buhle, SmithKline Beecham
|James Burke, Frontier Media Group
|Janet Carlson, J. Carlson & Associates
|Sandra Eskin, AARP
|Larry Ganslaw, American College of Cardiology
|Carol Gillespie, Liposome Co.
|Neil Gray, Medical Forum, Inc.
|Mark Grebenau, Sandoz
|Sandy Kline, Fujisawa Medical Information
|John Lee, Unimed Pharmaceuticals
|Lawrence Liberti, Pharmaceutical Information Associates
|William McClymont, HTN, Inc.
|Michael Pozsgai, Eli Lilly
|Larry Sasich, Public Citizen Health Research Group John Scheffel, Physicians Online
|John Shannon, Glaxo Wellcome
|Sara Stein, Stanford Department of Psychiatry
|Ilisa Bernstein, Pharm.D., J.D.
|Cathy E. Conn
|Jerome A. Donlon, M.D., Ph.D.
|Melissa M. Moncavage, M.P.H.
|Nancy M. Ostrove, Ph.D.
|William B. Schultz, Esq.
|Edward L. Spenser, M.S., D.V.M.
A F T E R N O O N S E S S I O N
Discussion Group 2
Chat Rooms and News Groups
MR. SCHULTZ: We are going to start with Panel 2 this afternoon. It is on Internet chat rooms and news groups. I would like to start by having the people on the FDA panel introduce themselves since it is a new panel.
I'm Bill Schultz from the Office of Policy. Next to me is Ilisa Bernstein, also from the Office of Policy.
MS. MONCAVAGE: Melissa Moncavage. I am a public-health advisor in the Division of Drug Marketing, Advertising and Communications.
DR. DONLON: Jerry Donlon. I am the Office Director for the Office of Establishment Licensing and Product Surveillance in the Center for Biologics, Evaluation and Research.
MS. CONN: Cathy Conn. I am Deputy Director, Division of Case Management in the Office of Compliance, Center for Biologics.
DR. OSTROVE: Nancy Ostrove. I am Public Health Analyst in the Division of Drug Marketing, Advertising and Communications in the Center for Drugs.
MR. SPENSER: I am Ed Spenser. I am with the Center for Vet Med, Division of Surveillance.
MS. WOLF: I am Deborah Wolf. I am Regulatory Counsel for the Promotion and Advertising Policy Staff at the Center for Devices.
MR. SCHULTZ: Thank you. The moderator for our second panel is Linda Golodner who is the President of the National Consumers League where she has been either President or Executive Director since 1985. The National Consumers League has programs on a wide variety of healthcare issues including food and drug safety.
So now I think I will turn to her and let her introduce the panel.
MS. GOLODNER: Thank you. I also wanted to mention that the National Consumers League also runs the Internet Fraud Watch and we see a lot of things out there on the Net that are quite amazing.
I want the panel now to introduce themselves and just state your name and the organization you are representing.
MR. BOULDING: My name is Mark Boulding. I am a partner with the Washington law firm of Fox, Bennett and Turner which focuses on healthcare issues.
DR. BUHLE: My name is Loren Buhle. I am with SmithKline Beecham and also the creator of Oncolink.
MR. BURKE: My name is Jim Burke. I am with Frontier Media Group. We design interactive communications for the healthcare industry.
MS. CARLSON: My name is Janet Carlson, President of J. Carlson & Associates, an Internet consulting company.
MS. ESKIN: My name is Sandra Eskin. I am representing AARP, the American Association of Retired Persons.
MS. GILLESPIE: I am Carol Gillespie. I am General Counsel for the Liposome Company.
MR. GANSLAW: My name is Lawrence Ganslaw. I represent the American College of Cardiology.
DR. GREBENAU: Mark Grebenau, Medical Services, Sandoz Pharmaceuticals.
DR. KLINE: Sandy Kline, Fujisawa, USA.
MR. LEE: I am John Lee with Unimed Pharmaceuticals.
MR. LIBERTI: Larry Liberti, President of Pharmaceutical Information Associates, Ltd.
MR. McCLYMONT: Bill McClymont, Hypertension Network.
MR. POZSGAI: Mike Pozsgai, Eli Lilly.
MR. SASICH: Larry Sasich, Public Citizen Health Research Group.
MR. SCHEFFEL: Jack Scheffel, General Counsel of Physicians Online.
MR. SHANNON: John Shannon, Glaxo Wellcome.
DR. STEIN: Sara Stein, Stanford Department of Psychiatry and also Consulting Psychiatrist to ChemTrack, Incorporated, one of the companies marketing home HIV testing.
MS. BOROW: Wendy Borow, President of Com-Med Interactive Medicus New Media.
MS. GOLODNER: This session is on chat rooms and news groups. I just wanted to quote from the FDA information that chat rooms are Internet locations where users can have real-time conversations with other users. News groups are Internet locations where users can post messages for other users to read and/or respond to other posted messages.
The information discussed in chat rooms and posted in news groups is often focussed on a specific issue or interest and the FDA had several questions with regard to the chat rooms and news groups.
I wanted to pose a couple of other questions. As a consumer group, we are very concerned about privacy and we want to know is there adequate disclosure to the consumer in these news groups or chat rooms that would protect that privacy.
Is there the potential that personal identifiable information will be used by a third party for commercial, promotional purposes or, perhaps, sold to an employer or a third party like and insurance company, and should risk and benefit information be required.
Do consumers understand that a chat room is not like just inviting guests into your own living room; it is a very large living room with maybe 63, as someone mentioned, people in the room or many more. It is not the same as just having a chat with someone else that you have chosen to have a chat with.
We have five questions for discussion. First, I wanted the same ground rules that were discussed this morning; no speeches, no monopolizing the discussion. We want to hear from everyone. Two minutes is your limit. There will be times when I might cut you off and I hope you don't think me rude. I just know that we have to move through those five questions.
In the middle of the discussion, we will be questioned also by the FDA panel. Then we will go back to the discussion and then have some additional questions from the FDA and then from the audience.
I want to make sure that you stay within the chat rooms and news groups criteria, but let's begin. As moderator, I am taking the prerogative of starting with the last question first because I feel that No. 5, which says, "What is the state of the art of technology or capability today with respect to chat rooms and news groups?" is very important.
I also think that we would look at what is happening in the next six months because, as you know, this media changes very rapidly.
Loren, you said that you would give us a little background on where we are now in chat rooms and news groups.
DR. BUHLE: The chat rooms and the news groups, and I will also throw in the list servers; it has been the tradition, the heaviest use of the Internet has always been E-mail and continues to be E-mail. Actually, it is probably even more important, in my opinion, than the webservers.
The Web is a library. The ability to talk and interact is paramount. We did it over lunch. Often, the most important part of meetings is the networking--not the computer networking but the talking that goes back and forth.
The rules are a little bit different. You are talking in a very public area where there are maybe thousands of lurkers. What you are talking about may be archived and may be seen years later by people you didn't necessarily even know were looking at it. This may serve a good purpose in that patients can look at and share other experiences, and you may end up in a law suit somewhere there. So "buyer beware" is very important.
Another area is, unlike the Web where you have to go to a resource and make an active request for information, the power of marketing can sometimes overwhelm the scientific information.
This has been pretty much limited by people having access to computers and access to typing, although that is getting less and less so as we move to video communication. Obviously, those who market cars know that video can sell where content is fairly small.
So I envision, probably in a very limited scope, the video marketing driven out of the entertainment business. But healthcare is one of the most significant purchasing areas and concerns about your and my healthcare. It is still done one-on-one where the Internet works beautifully.
So I expect video, as technology occurs in the next six months to a year, to start to go. So anything we talk about here, we say in text and quoted should be inferred to also mean in video and for storage. So the issues of privacy, of content, of context, of being solicited, not me going and looking for it, are paramount in this area.
I also see, and it is probably the most driving area of the Internet, the ability to interact.
MS. GOLODNER: When someone wants to speak, would you please put your name plate on end. Is there anyone else that wants to talk about where we are now and where we may be going in the future?
MR. SASICH: Just to raise Linda's privacy issue as far as logging on to a chat room goes. My understanding, at least at some sites on the Internet, that one is able to capture an individual's E-mail address and then, subsequently, target that person for a specific kind of advertising.
I suppose if that was the case and if we use an example of HIV, for instance, that if somebody logged onto a news group or a chat room about an HIV fraud, then, conceivably, somebody could link the individual's E-mail address with this particular disease and then that information would be for sale on the open market.
MR. SASICH: That is correct. However, there is the comment that what is your E-mail does not necessarily mean that you are sitting there. I could use your E-mail address with amazing ease. So there is an issue of difficulty in actually identifying who is the person that is actually responding.
This is a general issue as well. It can be handled but, in this area, is not.
MS. GOLODNER: Any other comments on where we are now?
MR. BOULDING: Just to elaborate on the point that was just made, I think it is interesting from FDA's perspective as an enforcement agency, to think about the practice on the Internet which has existed historically of anonymity.
It is almost customary, in some areas, to hide your identity. Depending on the underlying technology that is used, it will continue to be so. I think as you see the websites incorporating within the HTML coding, the ability to do chat rooms and discussion groups, there is more control, more potential control, over those.
But the traditional news group protocol and mail protocols really, I think, will continue to support anonymity which makes enforcement on fringe areas quite difficult.
MS. GOLODNER: I would like to go now to the first question, and that is, "Do companies maintain or sponsor chat rooms or news groups about their FDA-regulated products and, if so, what is your experience to date? If not, what are the reasons for not doing so?
MR. POZSGAI: Currently, we do not sponsor chat rooms or any news groups related to our products. One of the interesting aspects for consumer-related information out there--consumers are looking for disease-related information, moreover, from product information.
So, along the lines of disease-related information sites, there is quite a bit of room in the future for that.
MR. SASICH: Not having an exact definition of a chat room or a news group until this morning, last week, I had logged onto the Internet to see if I could find out some information about a drug. This particular drug that I was interested in was an analgesic. I did find a news group about it, or what appeared to be a news group.
There were some messages there that had been left by consumers. There was also a link. I activated the link and went to a very nicely done page that described the drug in about a page and a half. More than this, I was interested in who wrote it. I had the name of the corporation that wrote it or the publisher that wrote it.
I went a little bit further and I found out that this was actually a company that was in the business of creating continuing education programs, writing research articles for pharmaceutical manufacturers, abstracts, this kind of material.
But I was left without knowing whether or not the manufacturer of the drug had actually written this. The reason that I raise this question was that the material was out of date and it did not accurately reflect a very recent warning that the FDA had required on this drug about seizure, about allergic reaction and about addiction.
MS. GOLODNER: So you are saying that there is this problem of disclosure in the chat rooms and news groups.
MR. SASICH: Right. And I really can't believe that the manufacturer of this drug didn't know what was in this particular piece of information since this is a company that is in the business of writing for pharmaceutical manufacturers and I wouldn't believe that they were doing this for nothing.
MS. GOLODNER: Does anybody else have any experience on that?
DR. BUHLE: SmithKline Beecham does not currently have any chat rooms or news groups, but from my fairly extensive experience as a contractor, these are very, very popular. However, any avenue of communication, regardless of the intent of the communication such as psychosocial support groups, which is a huge area, adverse event reporting will go through that.
I don't care what the label is that you put on it; it goes through, if there is an avenue to communicate. There are also questions of competitor products; who is better. There are questions that are clearly medical; how much of what should I take.
There are areas where a phone call is probably better to handle the situation, so there is an issue of getting the demographics so that we can do a good job at replying or doing due-diligence.
In terms of news groups, there is the moderated and the unmoderated. With moderated, it means that there is a gatekeeper that says what can appear and what cannot appear. When you moderate, you are a publisher and you infer a liability in that it is approved to go out there.
If you are unmoderated, which is the bulk of the news groups and the listserves, it means anything flies. That means the volume is also fairly large. They are the legal areas if you are a common carrier; for example, the telephone company. They have little to say about what goes over the lines, just that the lines exist.
This is a decision of each group and the goal of what you are doing has to take that into account. But if you provide information, you will get a whole lot of other things there that can be of tremendous value as well as the adverse event that you must handle.
MS. BOROW: In our experience, a lot of companies have most concerns and most fears in terms of medical/legal and regulatory issues in terms of both news groups and chat rooms. So what we see is a lot of companies opting to provide funds to disease-affinity groups in allowing them to set up discussions and chats.
Of course, then, the issue is what Loren just raised, if somebody else--one of the concerns that people have is that they have provided an unrestricted grant to allow for a disease group to set up a discussion group and then something occurs in there that is either off-label or is incorrect, whose liability is that.
So now we even hear of companies who, even though they want to support the exchange of information, want to provide the funding for patient support, dialogues, discussions and chats, there is the concern of what happens once that goes out there
DR. GREBENAU: What Loren has just brought up brings up another point which I hadn't even considered before. Let's say a person from a pharmaceutical company happens to be monitoring, lurking, whatever, in a news group, let's say, and someone in that news group brings up an adverse reaction to a drug produced by that company.
Does that now become the responsibility of the person from the company to report that to the FDA? This might violate anonymity on the part of the person who reported this. He or she didn't know there was somebody from the company lurking. He or she was just sharing with friends that he or she had experienced this adverse reaction.
MS. GILLESPIE: I think the last two speakers have both really highlighted what some of our concerns would be. I don't think we would ever host a chat room or a news group, particularly an unmoderated one--well, we wouldn't moderate one because I think, then, clearly, you are undertaking an obligation to keep erroneous messages off of your site.
You are also, perhaps, undertaking an obligation to correct what is on there or to somehow exclude anything that deals with unapproved uses. It would just be a very tremendous burden to undertake.
On the other hand, if you don't moderate, your competitors are going to get on there and they are going to be promoting their products over yours. So what is the benefit? I think that these disease-related things are the way, really, that companies--what you want to do is get your company out there as a provider of services to the medical community so the doctors will look at you as authoritative and have a favorable association with your product.
You are going to do that by identifying with these disease groups, I think, more than by hosting your own chat room or news group.
MS. GOLODNER: I am going to move on and we are going to reintroduce ADF again. This is the clinical- research and development company. They currently market human and animal drugs, biologics and medical devices in the United States. "ADF knows that federal law and regulations prohibit the promotion of human and animal drugs, biologics and medical devices for unapproved uses and investigational uses. ADF wants to fund and operate a chat room or news groups focussed on a particular disease."
I am going to take those first two, (a) and (b) together, concerns of the company you would have to operate a chat room and news group, which I think you have just pointed out a couple of the concerns already, and what differs in their obligations for either, either the chat room or the news group.
DR. STEIN: I am a little bit disheartened to hear you say that you would not operate a chat group because of the liability of somebody saying something that might be incorrect. I think that kind of misinterprets the whole idea of what chat groups are.
First of all, most chat rooms are run by what they call robots, or "bots," so that it is actually kept open by a machine and there isn't a live person on there. Secondly, it is a forum for people to exchange ideas and information and, as long as a company provides a designated amount of information--for example, an hour a day with someone on-line for questions and answers--I don't see why the rest of the group should be restricted or monitored or censored in any way, perhaps just to look at the log and see what the misinterpretations are and to address those in the next day's educational session.
I think there is a lot of potential there for education of people that they wouldn't otherwise get to ask questions of professionals.
MR. SASICH: This is kind of a fundamental question for consumers; why is it that a manufacturer would want to run a chat room or a news groups. I would maintain, and throw this out just for the purpose of discussion, that the only reason is promotional.
If it was educational that, as has been suggested here and seems to be a word that has been used a lot that we can educate the public, with that idea in mind that industry and a lot of other provider groups are so interested in educating the public, I would ask why we weren't able to get from the FDA in 1979 patient package inserts for prescription drugs.
Now, we have bypassed a stone-age solution for an information problem for the public and now we have placed it off into the 21st Century. Everyone in industry seems to be running head over heels to be able to provide consumers with information.
DR. BUHLE: I think that there is a strong interest in providing general education, healthcare information. Most consumers do not go to a company looking for a particular drug; indeed, they don't even know what the company makes and don't care.
They have a disease. They are worried about what they are going to do next. So, general education, such as areas of women's health. Maybe the company doesn't even have a product but realizes there is an audience that has a strong interest in taking charge of their own healthcare.
I think it is the obligation of all of us, the pharmaceutical manufacturer or whatever, to make sure that the information, as best as we are able to make sure that information is correct, just as we would if it was published in JAMA or anywhere else.
If we can't moderate it, because, indeed, most of the news groups are not moderated, at least state our points, state the data as we know it. That is how I handle the snake-oil issues on the oncology listserves.
However, we are not obligated to correct everything everywhere. We do not correct every piece of graffiti that may be painted in some remote area of Australia or Alabama or Philadelphia, but we do respond where we feel this is significant and we need to clarify the issues.
DR. GREBENAU: One way in which it can be used which would not be promotional, and I think far more important than anything which would be promotional, would be to correct a piece of misinformation or to destroy a false rumor with the best thing for destroying rumors, and that is truth.
A person can put up a friend of a friend's story or start circulating something to be specific without naming a product. There may be a rumor that a certain product is going to be withdrawn at a certain time and if no one comes in and steps in who has a authoritative information and says, "This is not true," that kind of rumor can absolutely snowball and can become uncontrollable if it is not quashed right when it starts.
DR. STEIN: The advantage, I think, of having an expert in a chat room is that what happens in chat rooms is mostly anecdotal and mostly case-report type of sharing. So this is an opportunity for someone to come on-line and give more data, just as you said, and to monitor what the problems are that patients and callers are having with the product which might not otherwise be reported since not everything is reported and people don't run to their doctors if they are having mild side effects.
But, also, the other point I would like to make is that it seems as if we are minimizing the use of chat rooms into single products; for example, an antacid chat room. I like to think of it as more of a global educational and, perhaps, a little bit of altruism, even in the commercial domain, to educate people and try and improve awareness in bigger health levels.
So I would much rather see whole disease chat rooms or whole area chat rooms, cardiovascular, breast cancer, metastatic breast cancer, prostate cancer type rooms sponsored by the company, much in the way they do CME.
MR. GANSLAW: I would like to follow up on that by saying that I think that there has been an artificial distinction between promotion and education. Physicians generally understand that companies have commercial interest in promoting the products to them.
But at our annual scientific session, I believe that the members and the people who come recognize the exhibit hall is just as important a part of the educational activity of the meeting as the core sessions. There are things you cannot find out about in the sessions that are going to go on in that hall.
I think that generally, in talking about news groups, chat rooms, et cetera, that sort of bright-line distinction between promotion and education is very artificial. Physicians recognize this and I think that there is nothing wrong with patients getting this kind of information, at least coming to their physicians with them.
They can understand. They can make the distinctions. They can help draw those comparisons for patients.
MR. SASICH: Just a comment about what Sara said. Sara, in a one-hour educational intervention about a disease state in which there is a drug treatment that is manufactured by the underwriter of the chat room, where is the balance here for non-pharmacological interventions or something comparative with another manufacturer's product.
That is the thing that lacks in this between--the biggest difference between doing things for consumers and doing things for healthcare professionals. The consumers have enormous barriers to any kind of objective, comparative information and that is an issue that has to be dealt with before anything that goes up on the Internet can possibly be called educational.
MR. SHANNON: I would like to respond to Mr. Sasich's comment. Sites that Glaxo Wellcome maintains on the Internet; if we are doing a site that is disease-related, we are actually under a number of regulations that require us, and, plus, we just feel it is good practice, to be as balanced as possible in the information we provide.
I think that there is a case in favor of having a chat-room opportunity in proximity to balanced, accurate scientific information as opposed to being off somewhere among other news groups where there really may be no accurate information available.
One of the things that we need to always keep in mind when we are working with websites is we want to have a mechanism to bring people back to the information that we are trying to impart. I think having an opportunity for people to communicate with each other, perhaps discuss the issues that are presented on the site, is appropriate in that context, even if it is an unmoderated group, although with moderation, I think we have even more opportunities for balancing and insuring that information is accurate.
MR. SCHEFFEL: We operate to introduce a new buzzword into this conversation, an "Intranet;" that is, a private, authenticated network just for physicians. In that, and on that, network we find a lot of educational discussion, not at all promotional discussion because it is not at all tied to any pharmaceutical company of our sponsors within our discussion groups and news groups for doctors about pharmaceuticals.
We don't seed them. We create general discussion topics like psychiatry and find that regularly educational discussions between physicians break out concerning the pros and cons of specific pharmaceuticals or prescribing experiences they have had with specific pharmaceuticals.
So there is clearly, at least among professionals, an educational reason for discussion groups and news groups that is not promotional.
MS. GOLODNER: I want to move on to the FDA asking some questions now.
MR. SCHULTZ: Let me just ask a real quick follow-up question to the last comment to John Scheffel. Who finances those physician online networks?
MR. SCHEFFEL: There is no individual sponsorship of any discussion group or of most pieces of content on the service. We do have sponsors who show advertising on other parts of the service, but they are not directly associated with our discussion forums.
MR. SCHULTZ: Who are the sponsors.
MS. SCHEFFEL: Mostly pharmaceutical and device manufacturers.
MR. SCHULTZ: Who else on this panel has questions?
MS. GOLODNER: Any others? If not, I am going to move on to a scenario where we are back to ADF again. In their discussion of the following chat-room or news-group situations, there are four situations. One is, "Neither of manufacturer nor its employees participate in the chat room or news group." That would be a policy.
No. 2 is, "The manufacturer provides, on a formal and regular basis, for an expert or employee to participate in the chat room or offer feedback to questions raised in the chat room or news group."
No 3 is, "Employees of the manufacturer may informally participate in the chat room or offer feedback to questions raised." No, 4, "The chat room or news group is product-focused rather than disease-focused."
Do some of you have some comments?
DR. STEIN: Some of this appears to me to be internal policy which would depend on the differences between companies. In a company with 20,000 employees, they might not want any employee just going on-line and giving their opinion about a product that they know nothing about.
But a company with six employees may feel very differently where everybody is very well informed. So I am worried a little bit about over-regulating things which should be internal policy here.
MS. GOLODNER: What sorts of disclosures should be made in the forum?
DR. STEIN: Usually, when a person is in a chat room, they have an identification, a name. So, basically just saying who they are in a name would probably be sufficient. Also, chat rooms have titles, too, so you could say it is the Glaxo Hour or whatever you wanted.
I wanted to just add a little bit of additional information about IRC and chat rooms. There are at least two main IRC big servers in the country. One is Undernet which serves about 15,000 people a night in chat rooms, and there are up to about 1,000 chat rooms at a time. The other is the EF Net which serves anywhere from 15,000 to 30,000 people.
So there are an awful lot of people on-line. The potential for conversation runs a number of different ways so that people are able to message other people privately; they are able to open up a private chat room; they are able to simply observe without being seen. They can hide themselves.
There are a number of different ways which people can watch. So it is important for anyone in industry to recognize that anything that they can say is the same thing as if it was in print.
DR. BUHLE: To touch off that last area. Yes; anything they can say. People may be looking you don't realize even if you deleted--even it is called "private," Oliver North will remember that even though he deleted it, it came back to haunt him.
However, I agree with you that, in addition, most of these points follow company policy. Do we all speak informally about our products? No; there is usually a spokesperson who mentions their credentials. It says, in my particular case, I am speaking for SmithKline Beecham on this particular area.
If I am speaking as a private citizen, I credential myself as such. If I elect to have no credentials, then you have no clue to who I am. I see this as internal politics within the company, what is the precedence, not necessarily something that needs to be regulated.
MR. SCHEFFEL: There is another aspect of this that should go into ADF's discussion, sort of outside of the FDA regulatory context, which is the law in this area has generally developed that those who edit or police or comment upon what happens in news groups that they sponsor take on the liability of the publisher and they become responsible under some developing authority, principally the Stratton Oakmont Prodigy case, for the statements, potentially libelous, or potentially incorrect statements, that are in the group.
Conversely, if the sponsor stays out of editings or vetting what is in the group under Covey against CompuServe and some more recent cases, they are unlikely to have that kind of liability.
So, as an on-line service provider, there is a strong incentive for the way the law is developed to stay out of the business of trying to regulate or police that content, although there may be an obvious tension between that and the regulatory interest of maintaining a full balance of the information that is the group.
MS. GOLODNER: Any other comments on the employee?
MS. GILLESPIE: I think that, again, as counsel for a public company, I am very concerned that our communications need to satisfy SEC requirements as well as FDA requirements. I can review, or my staff can review, written publications. We can't review what goes on the Internet.
If you had an employee--you wouldn't have all your employees participating in these things--but I don't think you would want, generally, as a policy, to allow employees to participate as company representatives because you just don't know what they are going to say.
And they may not comply with all of the requirements that the subject to. And they will be speaking as a representative of the company and could get you in trouble.
MR. LEE: I want to support that view because when you have a number of employees in a lot of different disciplines, they may, erroneously, speak about a product. It may be over a lunch counter or in a casual setting. We can't monitor all of that but when we do know about it, and they have spoken outside of labeling, we take action with that employee.
I think we have to do our own due-diligence with our employees. To Sara's point earlier, that would be in the form of a directive that would be in a standard procedure that we would have with the employees. Just as we would not have them entertain calls from the media--they would refer those to the media department or public affairs--no more would they respond in a chat room that they weren't sponsoring or moderating.
MS. CARLSON: I agree with Sara. I think the different companies are going to have to look at the different situations, whether an employee is going to participate, whether they are discussing product-related or disease-related, because you have a menu of things to choose from.
You can create a multiple-user dimension or dungeon where you specifically decide who goes there. It is in a certain area where only those people are invited and know about it, and you can hold a conversation on just about anything.
You can then decide if it is going to be archived or how that information is handled. If it is public, I think you are going to have to limit who goes there and who says what just as the precedence that has been set up before. But I think it is a matter of looking at who is going to be there and what is going to be discussed and not throwing the whole thing out, but choosing an appropriate option.
MR. GANSLAW: I think that as a user of some of these services, the idea of requiring identifiers and eliminating anonymity sort of kills this medium, at least news groups. I think it is sort of antithetical to the whole idea of it. It is a free interchange of information. People don't want to disclose, "My father has had a heart attack and this is why I am asking this question."
Physicians don't always want to be identified as such. I think that requiring all these identifiers basically would bring the medium, if you will, this free interchange, to an end in many ways.
MR. LEE: I think we have to be very clear that on one end of the spectrum, we do have open chat rooms and those chat rooms are really no different than conversations over breakfast. As an employee of a company, if we overhear something that is erroneous, do we go and correct someone at a table across from us? Probably not. Do we have an obligation? I'm not sure.
But we probably don't get involved. On the other hand, the other end of that spectrum is if we are sponsoring a site and we find erroneous information being shared, then I think there is an obligation for us to identify ourselves and be very clear in a factual objective way what the correct information would be.
So I think that, at one end, there is involvement and it is known that the involvement is there by the sponsoring company. The other; it is an open chat room which is no different than an open restaurant in conversations going on.
MR. BOULDING: This is to sort of further the same point in response to the comment that there is a risk of killing this medium. I don't think FDA can kill this medium. But what it can do is to do what it has done historically which is to regulate the drug companies.
So, to the extent that a drug company is controlling all the aspects of a chat room, it might well be reasonable. I think it is reasonable that company employees identify themselves and there is some form of disclosure.
MR. SHANNON: In addition to erroneous information that we might come across, or our employees might come across, either in a chat room that is not sponsored by the company, in a news group that is not sponsored by the company or in a chat room that is a sponsored by the company, we might come across reports of adverse events.
I think that that is another issue that we probably should be discussing here at ADF. What steps should we take to report those. I think that there would be a responsibility, if we had the identity of the person, report them just as we would any other report of an adverse event, to our surveillance people.
MS. BOROW: I think, though, one of the issues that a lot of companies have is exactly the point that John just made; can a company be under the regulatory guidelines or rules--can a company, or should a company, feel responsible for trying to look at everything that could possibly be available and proactively looking for issues that are surrounding their product.
That would be impossible for any company, in any way, trying to audit what is on the Internet. But a lot of companies are fearful that beyond what they are directly involved in, other chat rooms, discussion groups, news groups, emerge, they may be scanning them not deliberately but may fall upon information that is erroneous.
What is their responsibility and if they don't fall upon it, but an agency finds it, what is going to be the net result on the company.
MR. POZSGAI: With regard to adverse-event reports, essentially, you are dealing with the situation of if you have an identifiable individual who is reporting a serious adverse event, that if you are able to identify that person, you have the need to do the reporting to that.
One of the issues regarding and open discussion group or chat group relates to where does that patient reside. Is he is U.S. citizen? What are our other practices in other sovereign countries related to that?
DR. STEIN: I would just like to say that I was on IRC a few nights ago and there was a guy there whose name was Bill Gates. I don't think I could verify that, but I feel pretty certain that he was an imposter--one of the problems with IRC and trying to regulate.
MS. GOLODNER: Loren, you want to talk about unrestricted educational grants.
DR. BUHLE: I think if you go back to the thing I said in the very beginning and that is to follow existing precedents in that when we find material that may be posted on a telephone pole that is incorrect, do we try to handle that? If it was in JAMA, definitely; we would probably clarify the issue with correct information.
I think the same is true with the news groups, chats, CUC, maybe the whole nine yards. Can we find it everywhere? We are not obligated to do it everywhere and so why should we suddenly have new regulations. We have to do it everywhere electronically. So I think the existing due-diligence; look in the usual places.
Now, let us say there is an adverse event and the person didn't know they were making an adverse event. If we try to chase it down and say, "Could you provide a little more detail, either privately or publicly?" or what have you, and they were forthcoming and Bill Gates turned out to give his phone number and his address, it very likely could be someone with the same name. I'm sure there are quite a few of them that don't have the same stock.
If we do the due-diligence of chasing down and find out more, then, first of all, we show an interest. We are following regulation and we care about the patient's interest. If they disappear, that also says something.
MS. GOLODNER: "ADF has given an unrestricted educational grant to an independent organization to operate a chat room or news group focussed on a particular disease." I think we see a lot of these out there.
Let's have some discussion on that. Let's talk about how ADF, in their discussions--what are their concerns regarding the operation of the chat room or news group since it is an unrestricted, educational grant. If they abide by what those words mean, then it is unrestricted.
MR. LIBERTI: Through our sister company, VirSci Corporation, we are involved with a number of on-line groups. These are primarily moderated E-mail groups, as Loren had talked about earlier. We have taken sort of the low-tech approach with E-mail because we feel that most people have access to E-mail and it allows physicians who may not be comfortable with access to some of the higher technologies to get involved with the discussions.
Some of the groups that we get involved with are moderated. Some are unmoderated. Some of the groups are sponsored through unrestricted educational grants, either to VirSci Corporation, in one case to an association.
We see a variety of levels of interaction in these groups. I think that the important thing is that the sponsors, and in the cases where there are unrestricted educational grants, have actually no interaction with the group at all.
We don't know if they monitor the group. We know that they have no contact with us with regard to what goes on in the group. VirSci Corporation has the ability to advertise the group through various Internet modalities. We also moderate some of these groups and some of the educational grant goes to paying honoraria to those physicians who need to spend time moderating the groups.
So this is very, very much been a hands-off experience for us. We have been doing these for about two years now. We are very interested in seeing the level of interaction that occurs.
These groups pick up on certain comments. Someone may start a thread. That thread then takes on its own life and sometimes those threads are very generic. They are very disease-oriented, sometimes product-oriented.
MR. BOULDING: First of all, in my experience, there are a lot of people who want to receive these educational grants. There are a lot of people who are interested in performing this role. The analogy, I think, is interesting but pretty clear to the draft-policy statement that FDA issued addressing scientific and medical-education activities.
Really, the question you are asking is is it possible to find a third-party organization to whom you give these grants that will remain truly independent and what are the measures to guarantee their independence.
One can look at the draft-policy statement and look at where it was successful and where it was not, but I think it is an interesting precedent that ought to be applied in this case.
Further to that point, and this is something we skipped over in the last discussion, but Point B, here, is a discussion of the difference between news groups and chat rooms. It was always, at least on the drug side of FDA, historical policy that, in a discussion that wasn't recorded, it was possible if a question was asked from the audience about off-label uses, to address it.
But then it was not possible for the company to republish that information. That is something that needs to be thought about here by ADF that, while you might well have a discussion that was completely on-label but provoked an off-label question, republishing that information would be a different ball game.
MS. GOLODNER: Loren, you might want to address the difference between the news groups or chat room receiving that unrestricted grant.
DR. BUHLE: I will address it. The conference setting is, I think, the scenario that most of this falls under. If you were to give an unrestricted educational grant and turn around a supply all the speakers, that clearly would not be so restricted. So I can see the precedence already exists.
My concern is what happens to the transcript of the discussion, because I think it is erroneous to assume nothing is recorded on the Internet. It is a good assumption to say that everything is recorded and will come back to each at numerous times, maybe out of context.
So those rules that say it wasn't recorded so no one remembers it are not valid anymore. Where is it going to come back? The things that were a side comment, that was done in private E-mail--which "private" is an erroneous label--will come back. That off-label conversation suddenly becomes published on an archive that is searchable out of context.
MR. GRAY: The issue of independence, I think, is one that the guidelines have set forth rather clearly. I also think that healthcare professionals are wiser sometimes than we give them credit for, from the perspective of understanding that not all roads lead to product.
For example, when we have seen the activities of manufacturers getting involved in guideline development, I think you can draw a parallel there that not all guidelines, when developed by manufacturers, are ultimately independent.
MR. GANSLAW: Speaking for a medical-specialty society, I think that the point has been made that there is an excellent parallel here to educational programming. The College, if it were to partake in any sponsored activity, would control the content and would be responsible for maintaining its redistribution in any form.
The companies, hypothetically, could walk into a symposia, tape record it and distribute it but, apart from that, the sort of ACCME provider organization takes responsibility for that. That design or that plan has worked very well in educational programming for some time.
I am not sure why there would need to be a different structure. We take that responsibility already.
MS. CARLSON: I guess one of the other things you have to worry about, other than things being reprinted or archived material, if you have a bulletin board going and that is a threaded conversation, that can last over a long period of time. Who is going to police that over a period of time? Who is going to come in if things have changed and then readdress other issues and what happens if that gets archived as well.
If you have a running, threaded conversation, there is going to have to be somebody from those companies maintaining what is being said there or where the end material is going. I guess the end products are what you have to worry about as well.
MS. GOLODNER: How do you feel about the employees of the manufacturer who gave this unrestricted grant participating?
MS. CARLSON: Well, you would still fall back on the rules that are pertinent today as far as unrestricted grants go. It is just a different medium.
MS. GOLODNER: I want you also to address how you disclose that unrestricted grant.
DR. STEIN: One of the things that I think that Larry and John would probably attest to is that people on IRC, people on chat channels, tend to police themselves. They certainly correct each other. They argue. They have a great deal of information.
While they are having a conversation, someone will excuse themselves, go on the net, come back with an entire URL. The capacity to go from a chat room directly into a website is there. So, actually, I suspect that most experts would wind up taking a very passive observational type of a role on these because the callers, the people themselves, the participants themselves, will do all the work, which is refreshing.
As far as disclosure, I don't know.
MR. SHANNON: As far as disclosure, and really as far as this whole issue, I think this is a case where we can say it is the same as another medium. As the point has been made, if it is independent, it is independent.
Janet, to the issue you were saying about who maintains the threads, it certainly wouldn't be the sponsoring company if it is an independent content site. We would follow the same procedures we would with the symposia or something.
As far as repurposing the material afterward, again, unless it was part of something that was agreed to up front, that wouldn't be something we would do. But disclosure, I think, just "sponsored by an educational grant from" and disclose the company name.
MR. SASICH: I think I can think outside of the Internet of at least two occasions in which pharmaceutical manufacturers supported disease-specific support groups. It took us a long time to find out that, in fact, these manufacturers were supporting these disease groups. These people were manufacturing the drugs that were the primary therapies, or what had become the primary therapies, for these conditions.
I am reasonably sure that there is no such thing as an unrestricted educational grant. It may appear unrestricted today, but I would be really interested to know about the second grant, if the recipient received a second grant, more than a first one.
MS. GILLESPIE: It is my view that whenever an employee of a pharmaceutical company participates in a chat room or news group that deals with his company's product, he should disclose his affiliation. Given that restriction, I am concerned that even this hands-off thing that we are sponsoring independently, if the company's employees participate too heavily, then it is going to look like it really isn't independent.
On the other hand, what is to restrict--I am getting back to the competitors here--what is to restrict them from coming and saying positive things about their product, negative things about yours. You can't stop that, obviously, because you are not participating.
So I would say that this whole thing would really have a tendency to come back and do more harm than it does good to the sponsor.
DR. GREBENAU: I would just add something as an important element to any disclaimer or disclosure which is made, and that would apply even more generally, not only to the company but to any professional participating in such a group.
It is tacitly understood in these groups, but it needs to be stated very frequently, that any professional who expresses a particular opinion about the treatment of a particular disease to a participant should tell the participant, "Please do not try this at home. See your own health professional. This is simply being given to you on an informational basis. Do not base your own therapy upon what is being said. Check with your medical professional."
MR. LIBERTI: Within the context of the mail list that we monitor, we do have a professional level group that has a physician moderator in addition to a couple of pharmacists that moderate the discussion. Coming back to the point about people, perhaps, trying to subvert another company's drug, that is where the moderators try to understand what is being proposed in a particular discussion.
You can become pretty astute pretty quickly to see what people are trying to say in these lists. If somebody comes through bashing something that seems a little too harsh, the moderator then takes the responsibility to query the person who sent the message, clarifies the issues and then, if the issues are relevant and legitimate, then posts the message to the list.
So there can be different levels of moderation. In some cases, there is no moderation at all and it is a free-for-all. But, in other cases, it can be quite well moderated, just as our discussions here today.
MR. POZSGAI: I think that core question that is coming about with regard to employee involvement is where is the line between the employee and the individual. In other words, as the employee goes home and becomes an individual who suffers from a disease, does the employee put his hat down and he is actually an individual with First Amendment rights.
I think that is a very key question to this.
DR. STEIN: I think it is important to remember that on IRC, there are vandals, hackers and bullies just like there are anywhere else. If they can't keep the Justice Department website safe.
What happens on IRC is that people invade the channel. They take the channel over and they kick all the people who are supposed to be on the channel off, and they can't get back on. So these kinds of takeovers occur nightly, regularly. They can be very vicious, but that is just part of the game that goes with it.
One of the things that we haven't talked about is the use of the robot that controls the channel and keeps it open on a regular basis. The robot can do anything. As an example, because I know many of you have never been on IRC or seen anything from a chat channel, one of the things that robots will do, for example, when a new person logs on, the robot will say, "Hell, Sara. Welcome to the FDA meeting."
The same robot can be programmed to say anything. It can also be programmed to recognize any employee's name. It can recognize a domain from an E-mail. There are a lot of safeguards that can be built in simply by the robot.
MR. SASICH: Sara, if the robot can be programmed to say anything, who buys the robot?
DR. STEIN: It is usually the person who runs the channel, that provides the program.
MR. SASICH: So that individual can program it to say anything.
DR. STEIN: Sure.
MR. SASICH: So then you could conceivably create a chat room that looks automatic that is actually being controlled by the person who owns the robot who did the programming and it can say whatever it wants, like, "Buy Drug X," "Buy Drug Y?"
DR. STEIN: Sure.
MR. SASICH: So a robot doesn't seem to be a solution to what we are talking about in terms of balance or disclosure.
DR. STEIN: No; the question was how to provide disclosure on a regular basis so that people knew where the funding was coming from. That is a method of delivering disclosure that is relatively easy.
MR. BOULDING: I just wanted to point out that we shouldn't get, I think, too hung up on specifics or particular technologies since I don't know how much longer they are likely to persist.
It seems to me pretty unlikely that any of the regulated industry will rely on the IRC technology. I imagine then, instead, building technologies based on web servers and using browsers as front ends which gives them, I think, the control that they are going to need.
DR. BUHLE: I think that the precedence in the television industry which is pretty much one way is "This program was brought to you by whoever" is clearly stated, well accepted that it might be brought to you by Xerox. That's fine for a PBS channel--that you have full disclosure. If there is a financial interest, it is nice to know what it is.
People will say, "Oh; it comes from that drug company. They will only say nice things." But they still come back because they really want to learn and they can always back away.
I agree that we shouldn't focus on technology because I guarantee tomorrow it will be different.
MS. GOLODNER: Just looking at the fourth question, and I think a lot of this has been already discussed about the employee of ADF who is surfing the Internet and he sees what the employee believes is erroneous information, do you feel that there should be disclosure again, that the employee coming into the chat room--do you think that there should be criteria with regard to the correctness of the information that that employee might want to change?
MR. SHANNON: I would like to just echo the comment that I think Dr. Grebenau made a few minutes ago that probably the first thing we would want to do rather than necessarily correcting the erroneous information, we might want to correct it but we would also want to say, "Consult your healthcare professional for the correct information," because there is always the possibility that we don't know the whole background of what is behind the question.
I think as far as a disclosure, certainly you would want to disclose you are from the company, but that would just be a matter of course, I think.
MR. LEE: There is a road to take on correcting erroneous information which is to go directly to the people who are monitoring the news group or the chat room. Rather than being involved in the conversation, we, outside of the chat room, send them an E-mail or, by snail-mail, an answer that says, "This is probably more appropriate given what I saw the other night."
That way, you take a higher road. You do it professionally, and then they can integrate that into their room that they are sponsoring. The company, in that situation, just corrects the information that was out there but doesn't take any involvement or any role in the actual discussion going on that night.
DR. GREBENAU: Within the limits of the time constraint, I would just like to give an example of something which actually occurred on a news groups on the Internet. This was a comment which was submitted to a use-net group by a person who later turned out to be a junior investigator investigating one of the drugs which we were still investigating experimentally.
He simply put on a small comment saying, "Boy; it is a really lousy drug." Unfortunately, since it was a double-blind study, he couldn't have known whether his patients were utilizing the drug or utilizing the placebo. We were later able, once we were informed about it, to track this person down, find out which group he was working with. The principal investigator was able to post a correction of what this junior investigator had put up.
Unfortunately, that was weeks later so, by then, the thread had been forgotten, quite conceivably. But that was the way we intervened at that time. In the future, being able to intervene more rapidly and stop this kind of promulgation of completely false information, or somebody commenting about something which he really could not have known under any circumstances, should be available.
DR. BUHLE: I think this goes back to policy. If you were to read something, or if I were to read something in a journal, something about SmithKline that I thought was incorrect, I would probably take it to those people that are responsible to answer for the company. I don't speak for the company in those particular matters, with the exception of if it is life threatening.
There is something that clearly there is an issue, here. I think that is covered by other rules. As it turns out, most of the time, people don't read. Quite frankly, the answer to the question of the erroneous information is maybe the answer is on your website.
We have spent all this time constructing these beautiful websites they just don't read. So, often, I find it useful to say, "That's an interesting comment. I look at this URL and I read such and such and such and such. What do you think about that?"
That, of course, brings everyone's attention to the information, the truth, of what's out there and starts further conversation. Into a vacuum, you can put truth or really wild information. So there is an issue of coming out. Who should do it? That follows on standard principles of your company.
MS. BOROW: I think that one thing, at least for the FDA's sake, we should, again, to echo what Mark said before, is the technology that exists today is going to change but, also, what most people in health are using are not even the classic "chats" but really more websites with bulletin boards for people to post questions that may be answered by either experts in some cases or by other patients that have had the shared disease.
I think that if we look at the numbers of health inquiries, they are probably less in the classic chat, just because the technology of the receivers is much easier for most consumers, particularly, not so much doctors to be able to have access to that kind of website posting of questions.
There it comes back to the rules of who is responsible for the content, who is actually hosting that. Is it on a website that is hosted by a manufacturer or has the manufacturer given a grant to a third party. Then I, again, echo what everyone else has said.
I think some of the rules that we already have in place in terms of independence and third-party editorial control should reign.
The other issue that I think we are kind of skirting around but is an issue, and I will just pose it, is that what happens if a company gives an unrestricted grant to a third party. The company already has a product that it has approved indication for in a specific disease area. But the company has another product that is it is working on that either has a coming-off label indication or it hasn't yet been approved.
The company has a vested interest in a disease category so they give the grant to the third party to host a discussion group for a lack of a better area, in AIDS. What happens once the company has now hands-off, something occurs there that is either off-label or talks about a product in a wrong way. Who is liable?
Those are some of the concerns that we heard that companies have and I think it might be useful to get some feedback from this group for the FDA.
MS. GOLODNER: Does anyone have any comments on that product-specific--
MR. GANSLAW: In didactic sessions at educational symposia and in virtually every specialty, off-label uses are discussed all the time.
MS. BOROW: Larry, for consumers. It is for the patients. That is where most, at least from what I hear, of the company concerns are, for patient-group support.
MR. GANSLAW: I go back to the comment that was made in the group before us that, of course, patients can't prescribe their own drugs and they will come with those questions, come armed with that information back. Based on Group No. 1, they discussed over and over again that consumers can't prescribe their own drugs. Eventually, their questions, their comments that come off of discussion groups, will come back to physicians who will make those ultimate decisions.
MS. GOLODNER: Sandra, there are more and more seniors on the Internet. Do you think there is enough disclosure about who is on the other end of the chat room and disclosure about who has put up the news groups?
MS. ESKIN: Not necessarily. I don't know how consistent the disclosure is now among these groups and in the particular areas. But, again, if these are a source of information for people, then, in certain instances, who is providing that source, who is sponsoring that source, is important to know.
MR. SASICH: I just wanted to make a comment to the other Larry that it is true, in fact, it is a physician, or other healthcare provider, that writes the prescription. But lay consumers do influence the choice of drug and this is a very, very important issue.
As I mentioned before, in the trade media, one of the purposes of direct-to-consumer advertising is to "drive consumers to doctors' offices, to mention the brand names of drugs." It seems that the doctors are very accommodating in writing prescriptions for brand names.
DR. STEIN: I think one of the issues that has to be clearly delineated by any company sponsoring a chat room or a news group is what is their ultimate goal. Is this goal to sell more of my product, in which case, what you basically want to set up is something like an "infomercial" where only good things will be said about your product and people will be supportive and always redirect it towards the same product over and over again.
Or do you want a sponsor, the classic unrestricted educational grant, which opens up a conversation about this disease process or this pharmaceutical process in which case, yes, people are going to say bad things about your product at times. They are going to bring in other products and you are not going to do anything about it.
So that is one choice.
DR. GREBENAU: I would like to address something that Larry just brought up about the fact that patients can actually have some influence on their caregivers with regard to the drugs that they are given.
It was brought up in the last discussion group that an educated patient is a very good consumer. A trend that I happen to be seeing on the Internet which I think is a very important one is that individuals are taking more and more responsibility for their own health and for their own care and that physicians are evolving into a position of not being dictators of healthcare but advisors to the patient on how to make an intelligent decision about it.
So that may not necessarily be a bad thing.
MR. SASICH: Until somebody can explain to me why the drug-consuming public doesn't have access to clear written information about the prescription drugs in non-technical language that reflects the FDA-approved material, I can't believe that anything that is being done is being done for an educational purpose.
It is just unbelievable that we would bypass a relatively inexpensive stone-age solution like the written word and jump head over heels into the 21st century and, all of a sudden, we are all worried about the patient's education. It makes no sense.
DR. BUHLE: As a point of history, when I created Oncolink, which I was not associated in any way, shape or form with a pharmaceutical, I put on lots of information which was reviewed with copyright permission. And it was consumed enormously including package inserts, including material from educational grants.
The thing that Mark Grebenau said about patients taking responsibility for their own healthcare and their patterns of care; were they more compliant or less compliant when alternate medicine came in. But they now were able to identify the issues and say, "What my physician says may not simply be good enough," or, "I understand why I am taking this and I understand what does not go."
So this has been done. The precedence is there that the pharmaceuticals were not leading the way. It was others that started it.
MR. LEE: I would rather that the impression that patients are not getting information about their drugs not be left. The retail pharmacy industry does a marvelous job of informing patients about adverse effects, about side effects. I am trying to avoid a policy issue here, but to the extent that they can, this industry does a very good job of giving patients information that helps them take home something they can read quietly and understand that is not under the pressure of a physician trying to share that information. It actually adds to that conversation they had with their physician.
So these patients do go home with something that is meaningful. There is not a complete lack of information.
MS. GOLODNER: I think Larry has a comment. He is jumping up and down.
MR. SASICH: I would like to refer you to two published pieces of material. One was done by Georgetown Medical School where they took 50 pairs of interacting drugs to 50 D.C. area pharmacies. Over 30 percent of those prescriptions left those pharmacies without a single written or spoken word being said to those individuals.
You should pick up a copy of the August 26 U.S. News and World Report. The cover story is "Danger in the Drugstore." The same type of study was done with three interacting combinations, seven cities in the United States, 245 pharmacies. This is why I can't believe that we are rushing off to the Internet without any consideration being given to the written word for these consumers. They are out there and they are very vulnerable.
MR. BOULDING: I think Larry, in a sense, has answered his own question here that it is not a given that a patient is going to read a written package insert. But we do know now that patients are now on the Internet looking for information and getting it. Whether or not the drug companies are providing part of it, it is going to be out there.
The fact of the matter is, in response to the direct question, information is educational. If you are saying it is false or misleading, that is different. But information is educational.
MR. SASICH: But if manufacturers who want to sponsor things on the Internet are actually interested in education, what about the problem as it exists now in the two studies that I just cited. Here we have a large portion of the population that is at risk of serious harm.
I am not talking about a drug interaction that will make you sleepy. These drug interactions were potentially life threatening. This is over 30 percent of the people who are leaving drugstores without any verbal or written information.
We are all talking here as if everybody in the United States has instant access to the Internet. My understanding is, and maybe somebody can correct me, that at least household-wise, we are talking about 14 percent of U.S. households--okay; it is higher--and that anybody that has a complaint could instantly run down to Egghead, I guess, and buy the right kinds of programs and write their own web page, of course, if they had the time and the money and the right kind of computer.
DR. GREBENAU: I would like to address what you just talked about, Larry; why are we rushing into the Internet. We are rushing into a form of technology. The gentleman sitting next to you can probably tell you about a wonderful feature on Physicians Online which is a drug interaction database.
It is the kind of thing that a patient isn't necessarily going to read or the pharmacist is not going to specifically have that information in a traditional medium. But if you put this kind of thing in an interactive database on the Internet so it can be updated constantly and the pharmacist can say, "Okay; this patient is getting these two drugs," puts in the names of those two drugs, and the screen turns red and says, "Don't do it. You are going to kill him," I think that is going to help out.
MR. SASICH: 98 percent of the pharmacies had computer systems.
MR. GRAY: I guess it is a question of how they use them, Larry. But it seems to me we are rushing to the Internet because we are in the midst of a revolutionary cascade as well with Rx going to OTC at a very rapid rate. It would also seem to me that any chance to educate is good.
I think the best comment made this morning was if we have informed patients working proactively with their healthcare providers, ultimately we yield better outcomes. We yield better health results.
MR. SASICH: I agree that patients should have information, and that that type of information is educational. But we have been waiting since 1979 for the written word.
MS. GOLODNER: Okay. Now to the FDA.
MR. SCHULTZ: I think Deborah Wolf has a question. She is from our Office of Compliance and Center for Devices.
MS. WOLF: Just sort of a technical clarification. When you are talking about the archiving of information from chat rooms or news groups, I had something come up recently where it was indicated to me that some information could be removed from a chat room within a couple of weeks by a moderator or that eventually, after about six months, it would automatically be deleted.
Just more in terms of what you've said about information coming back later, I just wanted to clarify what happens.
DR. BUHLE: Indeed, often, just because of sheer volume, the information that the outside audience can see is often removed or the message threads because the information may have changed over time. It is removed from public review. However, more often than not, it exists somewhere in an archive off in the listserve group or the chat room often archives it for liability issues.
I actually did this in the oncology area so that we could go back, instead of asking the same questions over and over, you go back three or four years to look at entire scenarios. It is a fascinating area of research.
On the other hand, certain people are going through and potentially eliminating employment opportunities because they found a name that matched yours in that archive three years ago and that person had a brain tumor. So these archives certainly exist.
Some of them are made very public, but they do exist and are open for your perusal. In most cases, it is archived somewhere. It may be archived by a user, not the moderator. If they happen to record, it saved everything that came across their computer in some place to be used by some material.
Is this copyright infringement? Absolutely.
MS. BERNSTEIN: So when you are saying "archive," is there any difference between a chat room or news group in terms of the archiving, or is it equal?
DR. BUHLE: The only difference between a chat or IRC or CUC means of technology is how fast it occurs, the simultaneousness of that interaction. The news group happens in time delayed, the same as news service. The fact it can be recorded and archived and indexed and repurposed at a later date is equal to both media.
MS. BERNSTEIN: In terms of correction information, because companies have come to us and said, "Well, if we see information out there that is wrong about our products, whether it is about an off-label or an on-label use, we want to be able to correct it."
Does it matter if it is in a chat room or a news group in that, for the most part, absent this archiving, the chat-room stuff goes away and the news-group stuff stays up on a bulletin board? Does it matter in terms of how the information is corrected?
DR. BUHLE: I take the precedence of something that occurred, let's us say, in a talk show on t.v. that had a very limited audience. I think that is incumbent on the company as to whether they want to correct it, just let it go, where they feel it is significant enough--perhaps it was in print or it was on Oprah or something like that, that they felt they needed to make a statement.
That is covered by existing guidelines. Actually, all those media could be recorded as well.
MS. SHANNON: I basically agree. On a chat room, it is much less likely, in many cases, that a wide number of people are going to see something. In most cases, the archives are not going to be kept publicly as long. But with news groups as with chat rooms, it is completely variable as to how long those archives are going to be available.
Often, it is dependent on your own Internet service provider. They will keep news groups up to a certain length of time, back a certain number of posts. After that, they are no longer available to the general public.
As well, with chat groups, it is more likely that--actually, I am not really positive that it is more likely, but in my experience, more people are going to be anonymous and all you will see of their post is their handle or their user name, whereas with a posting on a news group, they are more likely to give complete information such as E-mail return address.
DR. STEIN: Loren, I have a question. Can you explain what you are talking about about a violation of copyright?
DR. BUHLE: If there is material that I wrote, and it were to go out and were to be produced and reprinted in a journal, posted electronically and reposted, that would be, in my opinion, a copyright violation.
DR. STEIN: Oh; okay.
DR. BUHLE: If you were to quote a sentence or two, that fair use may come up. I would also like to give a sense of the proportion. The 15,000 to 30,000 users on chat rooms is actually very, very small in my opinion. The oncology listserves, just the listserves, is about 18 million. So this is a very small area. It requires special technology and, most importantly, it requires you have a particular part of your time of day to be there and do that across your continents versus listserves, it is whenever you do your E-mail at your convenience.
So that is a much, much larger audience and a much lower technology.
MR. SCHULTZ: Why don't I turn it back to you for statements from the audience.
MS. GOLODNER: Would the audience like to participate and please line up at the microphones.
MR. GROSSMAN: My name is Todd Grossman. I am with PR Newswire. We are in the business of disseminating press releases to the media and the financial community. A number of our clients are pharmaceutical companies.
One thing that wasn't addressed here was that there are over 18,000 news groups out there on the Internet. Our service, along with other services out there, can provide to pharmaceutical companies the opportunity to post their press releases in all pertinent news groups.
So if you have an AIDS-related press release, we can put that in all the AIDS-related news groups. That is something that I think should be discussed.
The other issue is that it was mentioned here that it would be virtually impossible to monitor all the news groups out there. But there are services there that can represent pharmaceutical companies that can set up severe, very good search engines and set up key words, and provide you 24-hours a day, instant news on what is being said on those particular news group.
In addition to that, the services can reply back to these news groups and post responses back.
MS. GOLODNER: Is there any response to that?
DR. BUHLE: I have a response and that is it is my understanding that press releases have a limited life span. If I were to run a press release in The Wall Street Journal for seven days running, that would be an advertisement. If you were to keep press releases around for a long period of time, I question whether that is truly a press release.
MR. GROSSMAN: The press release is up there for two weeks.
DR. BUHLE: You have no archives of press releases?
MR. GROSSMAN: All the on-line services and databases such as Nexus, then are archived.
MS. GOLODNER: I am going to alternate on the microphones.
MS. TODD: Leslie Todd, Vivus. A couple of things. It would be nice if competing companies could purchase a tape or cooperate in funding news groups or chat rooms and so forth. If industry doesn't fund it, who will? But it would be nice if there could be a cooperation.
Also employees can be patients. I think somebody mentioned that before. They have rights to anonymity, too. What they do on behalf of a company, on company time, on company computers and on a company domain name is one thing. But what they do at home at midnight in the darkness of their room on their own computer is another.
It is a real question in my mind.
MS. GOLODNER: Good comment.
MR. GRACE: Frank Grace from Synermed. We are in the education business. When you talked about the issue with regard to employees speaking on behalf of companies and should they be recognized, it seems to me that there are probably eight or ten people in a major corporation that any corporation would want to be speaking on behalf of them.
So I think you would restrict their rights to freedom of information by doing that.
The second issue is that we heard from the Public Citizen Group about 70 percent of the people that left with information, I think that is another example of how the public citizen wants to take that side of it. I'm sorry; he said 30 percent didn't. I would rather say 70 percent did, and the trend is probably increasing tremendously.
So the pharmaceutical industry is responding. I would rather look at where we can use a new medium to help us to reach the objective of better patient education in general.
MS. GOLODNER: Do you want to respond to that at all, Larry?
MR. SASICH: I suppose if we had gotten to the point where 30 percent of patients are leaving pharmacies without any written or verbal warning about potentially life-threatening drug interactions, and this process has been going on with the pharmaceutical industry to get them to voluntarily provide this kind of information to consumers since 1979, I suppose we can call this rocketing forward or going to a very high level.
I think I would call it otherwise. But it is still 30 percent of the population, of the prescription-consuming public, that is at risk.
MR. HEALY: My name is Chris Healy. I am an attorney with Hogan & Hartson in Washington, D.C. One issue that I didn't hear touched on was the impact that chat rooms and news groups can have on clinical investigations. The Wall Street Journal picked up this story some months ago and discussed a study involving a late-stage MS product that was severely harmed, I guess is the way to phrase it, by a chat group that was made up of late-stage MS sufferers who discussed the drug and its side effects and its impact on them at length and made going forward with the study very difficult.
So I was wondering if there were any comments on that.
MS. GOLODNER: I think John Lee has a comment on that.
MR. LEE: And I am from Unimed Pharmaceuticals. I think you bring up a very valuable point. Specific to the needs in orphan-drug areas where patients are few and far between, the Internet is a magnificent way for them to share their experiences and learn how they might improve the situation.
With protocols for drug studies as strict as they are and as few patients as there are in these orphan areas, it is very difficult to recruit in many cases. While we don't want to recruit directly from the patients, at least if there is a way, and I am not specifically talking about a news group or a chat room or a bulletin board, I am just saying in general, the Internet is a great way for patients to let someone know that they would like to be included in studies that are very meaningful and are targeted at very small audiences.
DR. BUHLE: I feel, especially with representation from other patient groups, that the value of finding the clinical trial far outweighs any of the risk. I remember The Wall Street Journal story. I was actually in that story. But I still feel often that the physician doesn't know what is down the street. It might be a competing institution, or they just don't have time.
One comment, I think, is critical and that is we are talking about a small group of the population that cares to make a difference about their health. There is a large part of our population that has no interest in their health, doesn't read anything and will never use the Internet. Even if their pharmacist tells them, they wouldn't pay attention.
We are looking at the section that does care and wants to find the clinical trial no matter where it is. Yes; there is an issue. They all assume that they are going to be in the experimental arm of that clinical trial. But, discussing it, at least we get them through the first base of that trial.
MR. LEE: John Lee, Unimed Pharmaceuticals. This morning there was a comment that at least I took to mean that patients might get false hope from knowing about a clinical study from which they would benefit if they were in a part of the country where the study was not being held.
I know for a fact that if enough patients can be identified and a researcher can be put with that group, most of us doing that kind of research would like to pull that together and if it is in Phoenix or if it is in Washington or if it is in Tulsa, it really doesn't matter as long as we can coalesce a critical mass and get that done.
So I think that is another great way to use this media.
DR. GREBENAU: I would like to add on what was just said concerning the information being shared. It is not only information about studies. It is sometimes even information on how to get the studies if you can't get there. There have been many discussions people bring up on some of the cancer-related news groups. "I have to go for chemotherapy and it is five or six states away."
And they talk about corporate angels and other corporate jets which are made available by industries outside of the drug industry altogether as a humanitarian move to help people get to their chemotherapy.
So this is also a medium for that kind of information.
MR. SCOTT: Mike Scott, CoMed Communications. I have a question for members of the panel. We are discussing here specifically the commercially supported chat rooms and their implications to the FDA for regulation. It would be my perspective that, in fact, probably 95 percent or a higher percentage of all the chat rooms that have had anything to do with healthcare are not, in fact, sponsored by the pharmaceutical industry or any other part of the healthcare industry outside some very fairly well defined groups like universities and things like that.
If I am wrong about that, I would like to know because I think that is an important issue.
DR. BUHLE: I believe that is a correct statement as it stands today, and I could make the same statement four years ago, that most of the websites were university only and nowadays most of them are commercial.
That is a trend that changed. As commercial organizations realized the value and the huge impact of talking directly to their consumers, future consumers and competitors, they will change this. It follows with the money, very simply.
MR. BOULDING: I think the comment really gets to an enforcement problem here that it is quite difficult, I think, for any regulatory agency to take any action in the kind of environment that exists now for chat rooms or news groups where it is so easy to assure your complete anonymity.
So there is a problem with dealing with bad actors. I am not sure how it is resolved unless we move towards the technologies that Loren describes.
MS. SCHEFFEL: Also, in the context of this discussion, whatever the constitutional limits of the government's ability to regulate truthful speech is, it seems to me that the FDA can't have a claim to regulate chat groups or news groups that don't have any connection to the pharmaceutical industry as well.
MR. ARMSTRONG: Neil Armstrong, Teleflex Medical. The European Medical Device Directive puts very definite responsibility on manufacturers of medical devices for post-market surveillance for being proactive and getting user feedback. A number of European medical companies are looking at chat rooms and news groups as a very easy cost-effective method of getting this feedback.
The trials that have been done so far have proved incredibly successful. With this in mind, it, of course, crosses national boundaries and information gathered for meeting the European regulations will, of course, also possibly contain responses from U.S. patients.
MS. GOLODNER: Good comment.
MR. MARKS: My name is Jamie Marks. My company publishes The Body, which is a major AIDS and HIV information resource. Back in February when the Communications Decency Act was being passed as part of the Telecommunications Act, we took a look at what that would mean for the prevention information we have at our site because we have that in addition to treatment and the quality-of-life information.
While courts have enjoined the enforcement of portions of that Act, there remains one section which is of some interest when we look at creating news groups or chat rooms, and that is the portion that exempts the major information service from liability for what other content providers, independent content providers, say within one information service.
I think that it may be advantageous to just take a look at that in the policy making around independent educational grants because the same test for independence--that is the pharmaceutical sponsor not intervening in the chat room or news group--would also bode well for insulation from liability under that provision of the Communications Decency Act.
I think it is Section 230. I don't think anyone has researched this or sought to apply this in this way yet, but it may be an instructive policy to look at.
MS. GOLODNER: Any comments?
MS. MENCH: Liz Mench, Medici Group. I think as I have listened to some of the discussion here, I think we are skirting around the issue of the value on which we place observational and experiential data.
This is essentially what is taking place in these news groups is that there is the power of patient-to-patient communications taking place because that is who other patients trust regardless of whether a pharmacist gives them information about a pharmaceutical at the time it is dispensed or not.
There is great power in talking to other patients. I think that what we are wrestling with within the industry and even within the scientific community is what value do we place on experiential data and observational data that is coming out in these groups and when is it, in fact, potentially off-label or when is it, in fact, an issue of a side effect and when should a company, in fact, act on that.
Just to give you an example, I know the National Breast Cancer Coalition started to receive numerous calls about a particular breast-cancer drug. They were hearing about certain adverse events. They reported it to the company that had not seen those.
So I think that we really have not been able to grapple with yet the value that we place on observational or non-experiential information.
MS. GOLODNER: Any comments?
DR. BUHLE: I think that many of the pharmaceutical companies have used focus groups in the past more for very targeted efforts. However, I think that is the real value--when you have walked in the shoes with the patient, you are a patient. It is very clear when you talk about it, you talk from the heart. That value is why I put the ability to socialize, to communicate, miles beyond the power of the Web.
This is what makes the Internet powerful. This includes AOL which is one of the chat rooms. That is actually probably the most successful commercial chat room so far. That is what is going to drive our market.
MS. GILLESPIE: The real problem, and I am interested in using the word, "trust," is you don't know who you are talking to. You don't know who is making these comments. It is the anonymity that makes it very difficult to assess the value of experiences allegedly reported through this media because we can't get behind the tags that people use.
I have seen people use tags that suggest that they are doctors. You don't know. A person who claims to be a patient may, in fact, be a drug company trying to say that its product is wonderful.
Again, I think the problem is not being able to really get any idea as to who is making these reports. I don't know that the technology, again--that is the real question; will it evolve to a point where that is no longer a problem.
DR. GREBENAU: One thing I want to comment on very briefly because it will probably entail a discussion of its own is the fact that a lot of the information which is going on from patient to patient, and which has the credence of being from a fellow sufferer, is that there can be the promulgation of certain "cures" which, in fact, are nothing of the sort.
I am not going to start commenting on alternative medicine because it certainly has a place, and we, in the scientific community, don't fully understand all that could be in alternative medicine.
But there is some frank quackery going on out there as well. With the anonymity issue, there is the real possibility of great harm being done to an individual.
MR. SASICH: I would like to support what Carol was saying, particularly about post-marketing surveillance. We have very little information about the comparative efficacy of drugs when they come on the market and it is very unlikely that we have the kind of information later on that will directly compare those drugs.
Some people have proposed that a way that healthcare professionals and patients can make decisions about their drugs is based on some kind of better adverse drug reaction reporting system, a better system than we have now, not the spontaneous reporting system.
So I can see what Carol was saying, that we could see a way to try to differentiate two products in the same competitive market because we don't know where those data are coming from.
DR. STEIN: Carol, actually I would like to take issue with what you said. I think that when it comes to identifying people on the Internet or finding out who they are or tracing their identity, what I would hope to see from manufacturers, pharmaceutical companies, is simply observation of patterns so that if there become a repetitive number of people complaining of the same side effect, it is likely there is some validity there, whereas an isolated comment from one person which is never substantiated or validated by any other person on the channel can probably be taken with a grain of salt.
But the idea of tracing someone's identity in an anonymous domain is very frightening to me.
MR. JOHN WALSH: My name is John Walsh. I am with Wyeth-Ayerst Laboratories. I would like to make three observations and then one recommendation. Observation 1; many of us in the industry are taking a very cautious, go-slow, approach that was outlined in a Reuters news article that came out yesterday. I believe, Ilisa, you were quoted in that as well.
Even though we agree there are challenges and we may disagree what they are, we all agree there is great opportunity here to do good things and great benefit that can come out of this.
Thirdly, I have heard consistently this is a new technology, let's not overregulate. So those being three observations, my recommendation would be tell us what we can do. If we don't know what is not going to work yet, if you can at least carve out pieces that are doable, that are acceptable, that are clearly beyond the line, we can start to seize the benefit and yet not incur the liability or get into the area where we do cause problems.
MS. GOLODNER: Any comments on that?
MR. HANSON: Dave Hanson with Glaxo Wellcome. First, real quick, on medication errors. It is a big issue. FDA dealt with it with AMA to a degree on September 30 with a hearing on medication errors. I believe that today is the second day of the Annenberg JCAHO, AMA, et cetera, et cetera, meeting on medical errors in general which is taking place at Rancho Mirage.
Hopefully, all that stuff will be available on Internet to help us all.
Number two, liability is another regulatory factor. I think the FDA attorneys always raise that for both claims you make promotionally. But here, on Internet, it sounds like product-related fact groups, liability is as much as a regulatory issue as is--it is probably a bigger issue than any FDA issues--disease is the way to go.
I think that there was a comment kind of at the end, the self-regulatory nature of chat rooms. No one has used the term yet "flamed." I am kind of a novice, but I understand that if you say something totally inappropriate, you can get flamed, burned to a crisp.
One cancer--disease-, not product-specific--chat group I saw, somebody came in with an alternative medicine, let's say, approach to trying to sell books and potions. And this person was crisped repeatedly.
It is one of the benefits, I think, of the technology that, again, you can go out. You get different people coming in saying, "That is wrong." Perhaps, if nothing else, I am not sure if a company needs to disclose, if someone goes in and says, "It is off-label, but the dose is totally wrong. It is going to kill somebody. It may be inappropriate investigational use," just go and say, "That information is wrong. Talk to your physician before you rely on it," and just back out.
Whether you need to disclose that--you haven't said anything otherwise. It is just, "There is something wrong about that information; check with your doctor."
MS. GOLODNER: Does the FDA have any other questions or comments? You are very quiet.
MR. SCHULTZ: We are listening very carefully. It has been extremely helpful. I want to thank you and the panel for spending the time. We will take all this into consideration. Thank you.
It is 25 of 3:00. Why don't we come back here at 3 o'clock. We will have two statements from Lee Peeler and Renardo Hicks. Then we will go into Panel 3.