|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 1
Investigational Use and "In the Pipeline"
Moderator: Wayne Pines
|Wendy Borow, Com-Med Interactive--Medicus New Media|
|Larry Carrier, Telectronics Pacing Systems|
|Louis Castelli, Rittenhouse Communications|
|Mario Cavallini, Slack, Inc.|
|Becky Cleavenger, AMGEN|
|Sandra Eskin, AARP|
|Renardo Hicks, Deputy Attorney General, Pennsylvania|
|Priya Jambhekar, Ohmeda Pharmaceutical Products|
|Janis Kelly, Medical Journalist|
|Kiyoshi Kuromiya, Critical Path AIDS Project|
|Thomas Merchant, SmithKline Beecham|
|Peter Reichertz, Arent, Fox|
|Al Rusch, Securities Exchange Commission|
|Patricia Shrader, Becton Dickinson Microbiology Systems|
|David Vance, Glaxo Wellcome, Inc.|
|Pam Weagraff, Hewlett Packard|
|Robert Whitaker, Center Watch|
|Tom Willer, Abbott Labs|
|Sidney Wolfe, Public Citizen Health Research Group|
|Ilisa Bernstein, Pharm.D., J.D.|
|Jerome A. Donlon, M.D., Ph.D.|
|William C. Keller, D.V.M.|
|Melissa M. Moncavage, M.P.H.|
|Louis A. Morris, Ph.D.|
|William B. Schultz, Esq.|
|Toni M. Stifano|
|Robert Temple, M.D.|
I think what I would like to do now is ask the FDA panel to introduce themselves and then we will call up our first panel. Bob, why don't we start with you.
DR. TEMPLE: I'm Bob Temple. I'm Associate Director of CDER for Medical Policy. The Division of Drug Advertising, Marketing and Communication reports to me.
MR. TART: I'm Byron Tart. I'm the Director of the Promotion and Advertising Policy Staff in the Office of Compliance, Center for Devices and Radiological Health.
MS. STIFANO: Toni Stifano, Acting Associate Director for Policy in the Office of Establishment Licensing and Product Surveillance within CBER.
DR. MORRIS: Lou Morris, Branch Chief for the Marketing Practices and Communications Branch in CDER.
DR. KELLER: Bill Keller, Director of the Division of Surveillance, Center for Veterinary Medicine.
DR. DONLON: Jerry Donlon, Director of the Office of Establishment Licensing and Product Surveillance in CBER. The Advertising and Promotion Labeling Staff in CBER reports to this office. CBER is the Center for Biologics Evaluation and Research.
MS. MONCAVAGE: Melissa Moncavage, Public Health Advisor in the Division of Drug Marketing, Advertising and Communications in the Center for Drug Evaluation and Research.
DR. BERNSTEIN: I'm Ilisa Bernstein, a Senior Science Policy Advisor in the Office of Policy within the Office of the Commissioner.
MR. SCHULTZ: I'm Bill Schultz in the Office of Policy.
I'd now like to introduce Wayne Pines. Wayne was Associate Commissioner for Public Affairs at the FDA between 1978 and 1982. He is now President of the Healthcare Practice at APCO Associates, which is a consulting firm. But, both before and since the time he was at the Agency, he has written widely on advertising issues, he's taught and I can't think of a better person for us to have moderating our first panel.
I think at this point he will come up and we would like to ask the first panel to come up and take their seats.
Discussion Group 1
Investigational Use and "In the Pipeline"
MR. PINES: I want to begin by commending the FDA for holding this public meeting. I've long been an advocate of a process like this to develop Agency policy. The Agency in the past has relied in some cases on its own internal resources in developing policy. This is clearly an indication, as there have been indications in other areas in the advertising and promotion area, that the Agency intends to reach out beyond its own resources to the public and to the experts in the field who are sitting here today in policy development.
The Agency has presented us moderators with an impossible task today. They've given us a panel of 20 people and very, very little time. Everybody here is here because they have volunteered, because they have a lot to say and they have very limited time in which to say it. So I'm going to set a few ground rules. By the time I'm done with this session, everybody in the room is going to be irritated with me, I'm afraid, because I'm going to have to cut people off.
I'm going to ask the panelists to limit their remarks at each instance to two minutes a piece. I know that's a short amount of time. But please do try to be succinct. There are 20 of you; we only have about 80 minutes, so each of you gets about four minutes. Be quick and be succinct.
I ask that you speak only when I call on you so that there is some order. I ask that you stay on topic. There are five topics. There are five panels that are going to be discussing various aspects of the Internet. We are not going to deal with chat rooms. We are not going to deal with international issues. Those are issues that are going to be dealt with by other panels. We're dealing with investigational products and I want to keep focussed on only that topic.
There will be opportunity for people sitting on the FDA panel to ask members of this panel questions and toward the end there is an opportunity for each of you in the audience to stand at this microphone and make your own comments. Again, I ask you to limit your comments to two minutes apiece.
I want to begin by asking the members of this panel to introduce themselves. You each get one sentence: name, rank and if you have a serial number blurt it out. But all I want to know is who you are and where you're from. Wendy, why don't we start with you. Everybody is sitting alphabetically, if that helps. You all have in your packets who the panel members are. So if you can follow the alphabet, you can probably figure out who's who up here.
MS. BOROW: I'm Wendy Borow, President of Com-Med Interactive, which is the new media division of Medicus.
MR. CARRIER: Larry Carrier, Regulatory Affairs, Telectronics.
DR. CASTELLI: I'm Louis Castelli, President of Rittenhouse Communications, which is a marketing and advertising firm and developer of Websites for pharmaceutical companies.
MR. CAVALLINI: Mario Cavallini, part of the Webmasters team at Slack, Incorporated, which is a medical publisher and involved in other forms of medical communications.
MS. CLEAVENGER: Becky Cleavenger, Regulatory Affairs at AMGEN.
MS. ESKIN: Sandra Eskin. I'm a consultant to AARP on food and drug issues.
MR. HICKS: I am Renardo Hicks. I'm the Director of the Public Protection Division in the Pennsylvania Attorney General's office.
MS. JAMBHEKAR: Priya Jambhekar, Ohmeda Pharmaceutical Company. I work in Regulatory Affairs.
MS. KELLY: Janis Kelly. I'm a medical journalist. I'm an ordinary working journalist. My beat is clinical research.
MR. KUROMIYA: I'm Kiyoshi Kuromiya from Philadelphia. I'm the Director of Critical Path AIDS Project and I'm wearing three hats: I'm a consumer of AIDS treatment information; I'm a content provider at www.critpath.org; and, I'm an Internet service provider in the Philadelphia area.
MR. MERCHANT: I'm Tom Merchant. I'm Senior Counsel at SmithKline Beecham Pharmaceuticals in Philadelphia.
MR. REICHERTZ: I'm Peter Reichertz, a partner in the law firm of Arent, Fox.
MR. RUSCH: To continue the barrister's roll, I'm Al Rusch. I'm Special Counsel, Division of Enforcement, SEC. This is the first time I've literally been in the dark.
MS. SHRADER: My name is Pat Shrader. I'm in Corporate Regulatory Affairs for Becton Dickinson, a medical device company.
MR. VANCE: I'm Dave Vance, attorney for HIV, oncology, dermatology, smoking cessation, depression and a whole bunch of other areas at Glaxo Wellcome.
MS. WEAGRAFF: Pam Weagraff. Regulatory Affairs Manager, Imaging Systems Division of Hewlett Packard's Medical Products Group.
MR. WHITAKER: I'm Bob Whitaker with Center Watch. We're a trade publication that covers the clinical trials industry and we run a Website where there are more than 2,000 clinical trials currently posted.
MR. WILLER: Tom Willer, Regulatory Affairs Manager, Abbott Laboratories.
DR. WOLFE: Sid Wolfe, Public Citizen Health Research Group. Depending on the project, an ally or an adversary of the FDA and the regulated industries.
MR. PINES: Was there a semi-colon between those two sentences?
DR. WOLFE: A colon.
MR. PINES: Just a colon? Okay.
Our panel will address the issue of how to discuss publicly products being investigated. We are dealing with medical devices, with drugs, with biologics, with veterinary drugs, with any product regulated by the FDA. FDA's position has long been that the promotion of products during the investigational stage should be limited.
The rationale is that premature promotion may unfairly raise public and health professional expectations and also may lead people to believe that the product will be found safe and effective for a particular use for which there is no substantial evidence of safety and effectiveness. At the same time, I think there is a recognition that the public is entitled to know the progress of medical research. There are many specific publics who need this information beyond the general public: the medical and scientific communities; the financial community, which invests huge sums in medical research.
The question of how we reconcile these two different needs has been addressed by FDA many times in the past. FDA has had to balance those different needs many times in the past. The Internet, of course, makes the issue much more complex because everyone has access to the Internet. It's impossible for anybody to control the Internet. FDA certainly, while it can control what pharmaceutical companies and medical device companies and biologics companies put on the Internet, really can't control what consumers or what medical researchers independently put on the Internet or what other sources put on the Internet. Anyone can discuss a new study or a new product.
FDA has posed for us a hypothetical situation. They've created a company called ADF. I want to turn now to the first question. It's all in your kits. What I'm going to do is read the question and then ask three of our panelists to begin our discussion by responding to the questions posed by the FDA.
The company's name--our company's name, because we are supposed to be representing a company up here--is ADF. We have a clinical research program for animal drugs, human drugs, biologics and medical devices. We want to post information on the Internet about our products that are currently being investigated or awaiting approval or clearance by the FDA.
We know that under current FDA regulations, a company may not represent in a promotional context that an investigational product is safe and effective for the purpose for which it is being investigated. We also know that the regulations are not intended to restrict the full exchange of scientific information.
Given the above, I want us to discuss how we can present information about investigational products on the Internet in a nonpromotional context and I want to discuss whether the presentation of our investigational uses over the Internet varies depending upon the intended audience--that is scientific or medical persons versus laypersons--and, if so, how.
Tom Merchant, I'd like to call on you. By the way, any panelist who wants to talk, and I'm going to start wandering out there a little bit, signal me somehow. You can go like this or something like that. Linda Golodner is going to have you put your name plates sideways. But signal me that you want to talk and I'm going to try to get to you as quickly as I can. I apologize about the size of the panel, but we are going to try to let everybody have an opportunity to speak.
MR. MERCHANT: First of all, in participating in this discussion at ADF, I'd want to know why they want to put this information on the Internet and what is their goal? For example, it's common for a company to present investigational information and a company's financial report in press releases. That information should be available on the Internet provided it's put up on the Net in the same context as one would do in other media, such as print or radio or television.
Secondly, another purpose might be to solicit volunteers to a role in clinical studies or to identify possible study sites that might be valuable in the continued investigation of these drugs. It seems to me that companies should be permitted to publish solicitations on the Internet that are of similar context to printed material that have been used in the past for the same purposes and they should be able to solicit study sites using the same criteria.
MR. VANCE: I think we are in pretty much the same place. The Internet is basically a work-in-progress and I think all of our positions are. The issues I think are regulatory judgment and enforcement discretion. The current regulations are more than adequate in my opinion. There are reasonable precedents for virtually everything. The only, in principle, difference is the speed of access to things that already exist and things that people are already doing and did you manage to focus on the abuses?
Clearly, companies should be able to put their securities-related materials, annual reports, et cetera, press releases on the Internet. These formats are reasonably easy to distinguish from other materials. Companies are already putting expanded access information and treatment use INDs on the Internet. The principle we've followed at Glaxo Wellcome is that no patient should suffer or die from a disease for which a treatment use IND or expanded access program is available without them and/or their physician knowing about such a program as an alternative to be considered and accepted or rejected.
We should be able to put information on for physicians and consumers about clinical trials that are currently enrolling. Clinical trial information is already available for certain diseases like HIV and oncology. The oncology activists have noted that those lists are often inadequate now. There is no reason why other patients shouldn't have that same right.
Even if a trial is not available in their area, they should know that such trials are occurring and, perhaps, if there is a trial in two East Coast cities and two West Coast cities, people in St. Louis should be able to say, "Hey, put one here. We'll even travel to Chicago to get there." Likewise, if there is not going to be one there, they can't get there, they at least know that something is available and perhaps they can push for compassionate access.
As to the identity of the viewer, we believe that the precedent set by AMA TV and by publicly available things like the New England Journal, which any consumer can read when they want to, if it's in lay language and it says "for consumers", it's in lay language, it's directed to consumers. If it says it's for a medical professional and it's written in medical jargon, it's intended for a medical professional but an AIDS activist is going to read it for sure. There's no reason why an activist in depression or an orphan disease or somebody else shouldn't be able to read it if they want to so they can go to their doctor.
DR. WOLFE: I'll just start off by disagreeing with the notion that the current regulations are adequate. That's a discussion for this afternoon, but we do not have any regulations for print, television, electronic, Internet, whatever having to do with direct-to-consumer promotion. Since the people who observe the Internet are mainly not physicians and scientists but consumers, I think that is a significant barrier.
But to the two specific questions here, the three variables that sort of come to mind to me when you evaluate any of these programs, beyond the important one, why are you doing it, are, one, what is the message itself? Is it mainly promotional or educational? Two, who paid to develop the message or who paid the messenger, directly or indirectly? And, three, the audience. This is a message that was given--I'm just reading and we're pretending this is ADF--by the president of a big drug company.
Our new drug, unapproved right now, will quote, "make all other nonsteroidal anti-inflammatories into dinosaurs" and then it proceeds to say it is much better than A and B. This happens to be something that was delivered to an audience of stock analysts. There is nothing wrong with that. The stock analysts have a right to learn things like this.
But what if the same message were put on the Internet, essentially promoting the unapproved use of an unapproved drug? I would argue that because this is someone paid by the president of a company that one has to start drawing lines. The lines, I think, will be easier to draw once we have regulations on direct-to-consumer advertising.
MS. BOROW: I guess what I would say is that we have to learn from the lessons of the past and that we need to look at the Internet as just an increased distribution mode. As David said, we learned that--when I was at the AMA--in terms of looking at American Medical Television that what was important was the intended audience and disclosure. Although Sidney and I will go on forever and ever agreeing to disagree on some areas that if a company and if we as ADF are clear that the information is coming from us, that the intended audience is to investors and physicians, that basically we need to look at the Internet just as an expansion of what we are currently doing in other mediums, in other distribution outlets.
When information gets sensitive, such as continuing medical education, which may be through a third party, and we need to disclose, as we do right now under the Agency's guidelines, where the funding is coming from. Then I do think there are places for certain registrations of sites. One of the things that we are all dismissing is that the Internet doesn't have to be a be-all or end-all or free-for-all. There are ways of regulating some access of some information if we all agree it is for certain intended audiences.
MR. CAVALLINI: I think it is a fundamental error to assume that the Internet in general and the Web in particular is just simply an extension of previous media. Major information providers can pretend that they are putting their print public on a wider distribution system. New users can pretend that they are coming into a new entertainment system. But it is fundamentally different.
One example is, in this question, there is a notion of context here. Context, to the extent that it is present at all, is an optional element. We saw in the presentation this morning that one can go to a search engine and go direct to a specific page without going through a company's context-setting pages. It is also quite possible, and I've seen it done, that somebody will take and copy material from a Web page and start posting it in news groups with comments. It is also quite possible that somebody will completely copy a page and put it on their own site, taking it from one context to another. The only specific context is what is actually on that particular page.
MR. PINES: What I would like the panel to address, if it would, is a fundamental question. With regard to investigational products, is there a difference between the Internet and between the pre-Internet forms of promotion? We've heard varying points of view here. Let's focus in on that particular subject because from a regulatory standpoint that's very important.
If FDA deems that the Internet is just another form of promotion that can be easily regulated with existing rules, then that makes it easy for them. If there are differences between the Internet and other forms of promotion that require special rules, then that is the challenge for the Agency. So I would like to ask panel members to address this.
DR. CASTELLI: I think one of the clear points we need to focus on is the idea that, as with all information, it is not just the intended sender and one of the things that the Web does raise is the fact that whether it is promotional or nonpromotional the context is really determined by the receiver. That's what raises, I think, the biggest issue.
Publishing, per se, that material, which is intended for a specific audience and only a specific audience has access to it, can be definitely of one type and not be considered promotional. That very same material put in another receiver's hands can be considered promotional. The issue then becomes that it is the receiver that defines the context, not necessarily the intender in the publishing world.
So if we focus precisely on the abilities of the Web and the Internet to eliminate portions of the receiving populace, that's where I think the focus should go. There are certain things, such things as, for example, I may not have access to certain documents, but if I have access to them I have an illegal access to them or an illegitimate access to them. The issue, for example, of pornography on the Web, has been dealt with. Some passive page where somebody says, "Yes, I am 18 or older," and if you are click here and you have admitted that you are. If you are not, then it is the receiver who is at fault, not the sender.
So I think it is very, very key that we concentrate on limiting access because it is the receiver who dictates the context, not the sender necessarily, in the Web.
MR. PINES: So do I glean from your remarks that different materials should be regulated in different ways and one of the parts of the regulation should be to restrict the access of the receiver in some way? That is, the company that's putting it on would create a system whereby access is limited and that's something that you would advocate?
DR. CASTELLI: And then it would be compatible with the intention. I think just saying that the intention is there without any steps on the reception end can certainly create problems.
MS. WEAGRAFF: I would say, first of all, my thinking on this is consistent with what you said, Dave, in terms of it's another means of communicating the information. I think the access, and the parallel that I draw to it, the gentleman over here just indicated in terms of the recipient of that information, is consistent with the current policy that the FDA has on printed scientific articles in that the manufacturers are at fault when they actively distribute scientific articles about their medical device, drug, et cetera.
However, if a customer--physician, whatever--approaches the company and requests from the company a copy of the article, then it's okay for the company to provide that information. That is the distinction that I would draw here in terms of the current material that we have available. If I get a phone call from Dr. Smith and he says, "I want the latest article on x, y, z," that's not a cleared intended use. As a regulatory manager I would provide that information to him, number one: we're not cleared for that intended use. However, we would provide a copy of that article.
MR. WHITAKER: I just wanted to say I don't think restricting access is a very doable solution. I really don't. I think one of the wonderful things about the Internet is what a great way it is to get out information and have, sort of, access to a large population. I just don't think it's workable. I think when you talk about investigational products, you have to look at the responsibility of who, in fact, is putting that information up.
I'll tell you what we did at Center Watch on our own with regard to posting information about clinical trials. We just required that those postings--and we get the postings from pharmaceutical companies, research centers--be IRB approved. That seemed to be going to how it's done with other mediums a very effective solution. We've surveyed our people who use our service and they find that because it's been IRB approved, nonpromotional and very straightforward. I just think if you try to find solutions by restricting access it's not a good solution.
DR. WOLFE: Although I would agree that certain drug ads border on pornographic, such as one about ten years ago explicitly promoting tranquilizers for air traffic controllers, I agree with Robert. We cannot assume that it is possible to restrict access. The assumption should be that anybody has access to the Internet.
The example I cited was actually presented at a stock analysts' conference, but then it was reported in Scrip, which you all are familiar with, international English language, excellent publication on drugs. But then the Scrip article was put by someone or other--I don't know who--on the Internet. Now, if that someone or other happens to be a drug company or one of its marketing people, then I would say that constitutes a violation.
So I agree with at least much of the last two, three persons' remarks that assume that the audience is going to get something out of context via various hits on the Internet and we have to figure out who put it there, why they put it there and what the content is going to be. I think it is very similar to non-Internet promotion in that sense.
MS. KELLY: I don't think that the Internet is different from the current situation because anybody who wants, for example, reports of investigational studies can go to the meetings. You can get the abstracts. The AIDS meeting abstracts were on the Web the day before the meeting opened. That only makes it a little quicker. But anybody can get that information. So what we have is just a kind of slight difference but it's not, in principle, a difference from what we have now.
I think that the idea of restricting access is not only not doable but a mistake in terms of communication and freedom of speech. If I'm covering a meeting and I have a Website for a newsletter I'm working on, I feel like anybody who is interested in immunology or cancer, whatever, should be able to read my stuff. The question of who puts it up, I think, is a more delicate one. Because, as I'm sure you all know, a lot of medical publishing--in fact, most medical publishing--is subsidized one way or another by the healthcare industry.
That's where I think the regulatory hot spot is. It seems to me that the point is whether the company with the bucks has any control over the content or is just paying for the site.
MR. VANCE: I'd like to make it real clear, we're not talking about the phone call after dinner that comes and is forced down your throat. The context here is we are talking about we're not forcing a detailer, we're not sending a mailer, we're not sending anything to anybody. These are people coming in and searching. It's their right to get information. It's a suffering, sick person, a person with a suffering family member, who wants to learn what's out there that can potentially help me.
It may be an investor looking to see what's out there I can make money with my investments? But basically we're talking about access for people who are searching. We're not forcing anything down their throats. If they choose to go, they now have this wonderful technology, which kind of in the context of some of the CME discussions and that policy here, they have the perfect opportunity for lots of hits, wide open discussion, going from place to place.
If they don't like what they see from a pharmaceutical company, they're not going to come back. They're going to have a low opinion of that. We don't risk our credibility. But they will very easily be able to go to a patient activist site. They can go to a chat room, see what other patients are saying. It is, in a way, a very good self-regulating situation with lots of information available.
If someone takes stuff out of context, they should be slapped. But an annual report is in context. A list of clinical trials is in context. And the patient who is looking, if they are really looking and potentially going to look at that information, they are not going to stop there if they are on the Net. They're going to look for more and more information and not until they've confirmed it in a couple of places are they going to say, "Hey, now I think I know something. I'd better go talk to a doctor."
MR. PINES: Before I go to the other two, I just wanted to ask you one question as a follow-up. In view of what you said, are you suggesting that because of the existence of the Internet there ought to be a different regulatory construct with regard to the distribution of information generally?
MR. VANCE: I still believe that in many ways what we have now is probably adequate. We put our annual reports out. We send an annual report to anybody who asks for it; we put it on the Internet; I don't see any difference with that. We put links to patient groups to CDC in our patient materials. People can contact them and get on- and off-label information whenever they want. Now they can just do it on computer.
We support patient forums with independent speakers at town hall meetings after every AIDS conference so people can go in and hear a medical expert synthesize that for them. And we support some of the newsletters that put that information on there, not in many ways different than chat groups. I think there are good precedents and as long as the information is explicitly "This is investigational," "This is off-label. It is independent," when it is that, that most of those rules would take care of most of what we are taking care of here and I don't think we need extra guidance.
MR. KUROMIYA: As a person with AIDS, it's of vital importance for me to have speedy access to information on investigational new drugs and drugs in development, to get information on expanded access programs, programs that AIDS activists have fought for over the years, speedy AIDS drug development and the ability to assess drugs in development. Any restrictions on our getting this information are going to cost us lives. Many of us have been using drugs that are currently in development.
As to the issue of what can be published on the Internet, I spent five days in federal court protecting First Amendment rights in the Communications Decency Act which, at least at the Philadelphia three-judge panel level, successfully defended our right to have access to information. If that law had been passed, information that I publish in my newsletter, information that I provide over my treatment hotline, could end me up in jail for two years or more and a $250,000 fine if I published it on my Website or published it through one of our mailing lists or through E-mail.
MR. HICKS: Pennsylvania is one of 39 states that are involved with attorney generals' offices in a collaborative effort to do investigative, analytical and other kinds of examinations of the Internet. One of the things that I think is worth noting very, very clearly is that the Internet really is not like other kinds of publication media.
It is not like other mediums because one of the things in the Communications Decency case in Philadelphia that was presented was that something like 40 percent of all that is published on the Internet comes from other countries, not from the United States but other countries. This underscores the breadth of any publication that people make on the Internet.
I'm largely involved in the business of fraud in my daily life. One of the other unique aspects of the Internet is that fraud, republication, occurs frequently. You can take something down from one person's Web page, send it through an OCR and republish it in any way you want to. So while the liability of the original publisher might be reasonably covered by the current FDA rule, because it says clearly that one may not represent, and a representation, if accurate, would be consistent with the current rule. But harm can result from republication, especially if it is republished in a modified way.
DR. CASTELLI: In no way did I mean by my comment to say that information should be restricted on the Web. First of all, as much of an advocate of the Web as I am, it's heresy and it's anathema to suggest any kind of information restriction. It's success and the reason it is such a phenomenon is precisely because it was based on the exchange of information.
However, I do believe that there may be, if we focus on the receiver, not by restricting but by giving the receiver a context, clearly identifying the context in which the information is sent, is meant to be, then we have a reasonable chance of coming up with some understanding that if I am reading x, y or z material, I am reading it in terms of for educational purposes, it's an exchange of information, as opposed to if I'm reading a, b, c, which is promotional in nature. I think there is something that can be done at that level.
The other reason I also wanted to mention about my opposition to restriction is that the Internet and the Web is definitely a growing phenomenon. It is, as all of us refer to it in the industry, the convergence point is coming. That is when all of a sudden we see the band width existing and television jumps on board and every other medium is going to jump aboard. So what we set up in terms of regulation should take that into consideration, not just publishing of text. There is other imaging.
MR. PINES: I'd like to ask anybody on the panel who has not spoken yet if they want to speak now before the FDA speaks.
MS. SHRADER: I just wanted to respond to a couple of comments that were made. First was on the issue of guidance. Speaking from the perspective of the medical device industry, I agree with Sidney, that we have had some verbal guidance. We do not have regulations and we have not had a lot of formal written guidance. I think that that has led to some problems.
There are, of course, in the device industry, as there are in the drug industry, a lot of very good, very ethical companies that work very hard to provide factual, truthful and not misleading information to anyone who is interested in receiving that information. One of the issues that I think we have to separate out is to what extent do we restrict the ability to distribute information based on a few bad actors as opposed to a lot of good ones?
The other thing that I wanted to comment on is the perception that somehow the information that is provided by scientists who are employed by a company is less useful than information that is provided by scientists who work, for example, for the government or for a research institution. Again, I go back to the idea that many companies work very hard to provide truthful information. They have regulatory affairs departments whose role is to review information that is distributed. I believe that the information that their scientists publish and that the companies distribute as a result is excellent information and very valuable to users.
MR. CAVALLINI: When Slack first became interested in the Internet, one of the questions that hit us in the face immediately is what does it mean to be a publisher now? A publisher is not simply a company that puts ink on paper. We got back to the fundamental truth of being a publisher, and that is being a credible source. A publisher is someone who takes raw information and presents it in a certain way and has certain quality controls and establishes a reputation for the reliability of their information.
That's the same sort of thing that operates on the Internet. I mentioned before that context is not optional. Nonetheless, different sites can have different types of credibility. If somebody is involved in a clinical trial and their uncle develops a rash, there is nothing that is going to stop them from putting up a homepage about "my uncle's terrible experience with drug x, y, z." But, there is a credibility issue there.
The point to this is that in any sort of regulation I don't think it is going to be feasible to try and rule out cases, to say thou shalt not, because there are going to be all sorts of people who are going to "shall" anyway. However, it may be possible to establish a code of conduct, for instance, to establish certain guidelines that one can put a shield up and say we adhere to these guidelines.
There is a site, and I'll give a URL here, www.hon.ch/conduct.html. This is for the health on the Net code of conduct. It's promulgated by a non-profit group in Geneva, Switzerland, which looks like a good starting point.
MR. VANCE: And it does address user confidentiality as a major issue of the Europeans.
MR. WILLER: One of the things I'm concerned about is intent of information on the Net, whether the intent is for direct-to-consumer kind of information or direct-to-medical community. This is the direction that I think we need the greatest amount of clarification.
MR. PINES: We are going to now turn to the FDA panel and we have about 15 minutes whereby this panel can question this panel. Let me see whether you need me for this.
DR. TEMPLE: I think I've heard substantial agreement that restricting access is a non-starter that's going to be impossible and expensive anyway and that therefore you have to focus on what's put into the Internet. There was a suggestion that what a company says to some parties, like stock brokers, is different from what they could reasonably say to other people. Apparently, you can distort and hype to stock brokers and you're not allowed to to others.
MR. PINES: That's our next topic.
DR. TEMPLE: Okay; I certainly wouldn't want to traffic in on that. But that raises the question of whether information is now essentially fungible to all parties and whether you need a sort of different set of assumptions, namely that the distinction between material directed at physicians and material directed at patients can be distinguished and, therefore, whether you need a more uniform standard for all information because of the expectation that everybody is going to see it. Is there a change in policy that is suggested by the ability of essentially anyone to look at anything and the likelihood that they will?
MR. WOLFE: Just a quick response, as I raised that issue. Bob, what I was saying was that I don't think we are ever going to want to or be able to go into a room at the Waldorf Astoria and stop the president of this drug company from hyping his or her product to analysts. I agree fully that from now on that goes into Scrip, the Scrip thing is put by the same drug company on the Internet and the assumption is that even though it was said to a limited audience that it is going to go to everyone.
That is not going to enhance our ability to control the initial thing. It's going to put a much higher weight on the value or the credibility of that president of the drug company because now their word is going to get out to other places unless it is regulated, which I think it should be.
DR. TEMPLE: Let me be clear on my question. When material goes to a sophisticated audience, you make some assumptions about what they know, what kind of training they've had, how they put things in context, knowledge about other drugs, all kinds of stuff. The question is, if you now know that all material is available to everybody, does that change--should that change--the kind of attitude one has toward, for example, including balance in the particular piece? Whereas, in an ad to physicians, you don't have to tell them about all of the other alternatives.
The question is if ads are going to be seen and witnessed by everybody, does that change the responsibility and the attitude toward what constitutes balance? That's really what I'm thinking about.
DR. WOLFE: The answer is yes and that's why we need regulations on direct-to-consumer advertising, which would then apply to the Internet.
MR. PINES: I'd like to get other members of the panel. Tom; who else wants to comment on that? Tom, Renardo, Dave; okay, and then we'll return back.
MR. MERCHANT: I think the answer is no, that nothing has changed. That we look at the context of where the information is presented and who the intended audience is and we allow the Internet to proceed as print and televised material and annual stockholders' meetings have proceeded in the past.
MR. HICKS: I disagree. I think the answer is yes, that something had changed, because there really is no way of determining exactly who it is that's going to be reviewing that page. Moreover, we in the United States are only dealing with information promulgated by people in the United States. If the same kind of material is put on in another country, the federal law is nothing more than a speed bump along the information superhighway.
MR. PINES: We're going to get to the international issues tomorrow so I'm going to cut off the discussion of that. Who else wanted to comment?
MS. CLEAVENGER: I think one way to handle this, the information that can be provided and the language in which it is written, is by organizing your site in such a way that your have information for investors--and perhaps your information that you are providing to investors is written in different language than it is information for patients--and additionally information for physicians in yet another, you know, perhaps, level of detail and getting in the fair balance, which is another topic also. But I think that organization of the site is important.
MS. KELLY: I think the answer is yes, it's changed, but what's changed is now everybody will know what people have previously been saying in secret to analysts when they were trying to jack their stock price. If you talk to anybody who covers clinical meetings, you will find that all of us hate drug company people coming into the press room and trying to get us to write stories on their drugs and it happens all the time. All of us know that most of the reports the analysts write from a clinical standpoint are absurd.
But I think that what is going to happen, following on Sidney's scenario, is that more and more everybody will know what everybody is saying and I think that is a good thing.
MR. SCHULTZ: Let me make one suggestion. If everybody before they speak could say their name, both for the reporter and also for the audience. Let me go to Byron Tart and then Lou Morris.
MR. TART: I think one of the issues that's been brought up--or two of the issues that have been brought up--today are access to information and, certainly, how patients need to have access to some of this information. What I am interested in is how the panel looks at information that appears on a homepage for a company. I think Mr. Vance alluded to this, that that information that appears on a homepage may be different than what companies have traditionally used to promote their products through brochures, or sales meetings, word of mouth, et cetera, sales people going out.
I just wondered if panel members saw the information on the company's homepage as something different than the traditional way to promote their products.
MS. WEAGRAFF: Our position right now is--we haven't proceeded yet in this direction and certainly are exploring it, however--the guidelines that we would apply to any information that we would post on a homepage would need to be able to pass the same review, both legal and regulatory, that any other material would need to pass that HP makes available to the public.
One point I think in addition is even though we say that advertisements directed towards physicians would never be seen by anybody else, I don't quite agree with that. There is no restriction on an average citizen walking into a library and trying to retrieve a medical journal and leafing through that for that information. So, in fact, although the information on the Internet is more readily available, our view is that it's the same information that would be available in print or some other format. It's simply a quicker way for the consumer or physician or whomever to gain access to it.
MR. VANCE: I agree. We've got to focus on the reality. If a high school student writes Glaxo Wellcome and says, "I'm doing a report on the pharmaceutical industry. Can you tell me about your company? Could I have your annual report?" we'll send an annual report. If someone says, "I'm a chronic diabetes sufferer. I'm not getting proper care right now. I'm trying to find out what other companies are doing. Can you send me your annual report?" we will send an annual report and say that we are doing research in diabetes.
All of these things are available. It's just that instead of having to write, instead of having to call, if you are searching, and only if you are searching, you use the Internet. As to what is in our annual report, a competitor, not on this panel, had a false and misleading report talking about how their drug under study was better than one of our drugs. That drug has since been stopped in development totally. It was an absolutely false statement. It was not material, so it was not an issue for SEC.
But FDA probably should have said, "This is ridiculous. You can be studying. You may be trying to get a drug better than the drug out on the market, and hopefully you are trying to get a drug that's better than what is on the market. That is fair as long as you are saying, 'It's an investigational drug. We're doing this kind of research. We're committed and people who are suffering from that disease ought to know and be able to find out what our company is doing, what companies are doing research so I can watch what might be available, what trials I can get into.'"
MS. JAMBHEKAR: I really think the information has not changed. What's changed is the access. Since it is going to a wider audience, probably easily, because right now if somebody really wants to get information they can. I think what should be made clear is that when the information is present that is out there, just like the print material, it should be made clear that it is unapproved information for clinical studies. It is to patients or to investigations or the reasons for which it is being presented.
MR. MORRIS: I guess one of the differences between searching through a medical journal and looking through the Internet is when I'm searching through a medical journal and I see an advertisement, it looks like an advertisement. When I click on the Internet, I don't know where I am. I could be anywhere on the Internet.
As Bob mentioned, restricted access doesn't seem to be--very few seem to be in favor of that and there is more discussion of context and how do I add context? One of the ways we think about it is disclosure. What needs to be disclosed so people know what the context is? So I would like to ask the panel to discuss what kind of disclosure or disclosures would help people know what they are seeing?
Is it the source of the message? You know, this is a drug company message. Is it who the intended audience is? You know, this is only for stockbrokers. Is it, "We have off-label use. Look here." What are the kind of disclosures that you feel would be appropriate and would help people understand kind of where they are?
MS. BOROW: I think it comes back to some of the things in terms of other mediums that we haven't resolved. I mean, we all know that brief summaries are still anything but brief; full disclosure in the ways that we've looked at it before hasn't worked. But contextually, even when I talked earlier about access, it's the context of how the information is presented.
And, yes, to Byron's question, it is the same, or it should be clear in terms of looking at a company's homepage that it's coming from the company. The role that we play as in advertising and meeting with responsible companies, companies have been really good about identifying that the information is coming from them. The problem is that because the medium, as Lou said before, is different, we can't block people from coming into certain sites in the middle of the site and taking the information out of context. So that in places where information may be sensitive, I think we do need to look at this medium as new and look at new ways.
I'll go back to American Medical Television. When we met with the Agency, and we had two sets of programming, one for the physician and one for the public, but they were both on public airways. Throughout the physician programming we had messages saying "The following information is designed for physician audiences. It is not intended for people without that proper training." We didn't restrict their access. It was just that the information was structured in a way that it was for physicians and then we did other programming that was clearly for consumers.
So I think the context in which, how you are leading it, so that if somebody still wants the information but we are not layering it, we are still designing the information for the first intended audience and identifying what the source is.
DR. CASTELLI: Lou, this is another Lou. I think basically you said 90 percent of what I was going to say. I just wanted to reinforce the idea that, for example, even in print media when in Time Magazine or in Newsweek they have a section that looks like an article but it is actually an advertisement, it is clearly stated that it is an advertisement.
It is identifying the context which will clarify the intent--in very little letters, you're right, Bob, very little letters, but it is, nevertheless there. You may whisper it on the Internet or whatever, but the idea is that you do connect the context and you create the context by virtue of your intent. Therefore, what that does is, again, going back to the idea that it provides all of the freedom of all of the information to everybody and that's what I think the Internet is about.
MR. MERCHANT: One of the problems we've encountered in designing sites is search engines. Search engines can bring you onto a site several layers down into your site so that the context is not apparent. That's been alluded to earlier. We have tried to take steps to a large practical extent to alert the reader, the visitor to the site, that they are at a site sponsored by the company, either by the use of the company name or a copyright notice or some similar type of notice.
Occasionally, we have thought it was reasonable to rely on the fact that the URL appearing at the top of the screen shows the company's site is what they are now visiting. We think it is important to have that in context.
MR. WHITAKER: I just wanted to address this question of confusion of advertising. There is a real potential for miscommunication here with the people of the Internet. For example, postings of clinical trials; the patients are likely to see that as just factual information when, in fact, for example, on our site those are paid ads. The sponsors are paying us to do that.
So I think the FDA, when it considers about how to handle information about clinical trials, should think of them in the same way you think of how are ads handled on newspapers and radio. I think they fit that same ball game. That's why we decided as a publisher--this goes with the sense of being a quality publisher--that they needed to be IRB approved, because that was a standard for newspapers. But there is a sense that the people on the Internet are not perceiving them as ads and that can be a little problem.
DR. WOLFE: I think that's an important point. Is it advertising and promotion or is it educational? I think that just as FDA now looks upon a variety of print items as promotional and advertising and therefore subject to all the regulations on advertising, even when they are changed to include direct-to-consumer advertising, a lot of these are, having disclosed who paid for it, still going to have to be subject to advertising regulations. If they violate them in the same kinds of ways that they are violated in print, they should be subject to some FDA regulatory action.
MR. KUROMIYA: As a patient advocate and a content publisher, we try to provide context when we list clinical trials. That's why we publish the full-text protocols of AIDS clinical trials group protocols and community programs for clinical research on AIDS protocols, the two large AIDS clinical trials networks. In providing multiple streams for accessing full-text information, we feel that we are providing a means of context.
MS. KELLY: The one concrete thing I think I would like to add is that I think on company sites and other places funding for studies should be identified. When abstracts, for instance, are published, then I think that if they were funded by a company site that people should know that. But I think it is going to cause a real problem if we get into thinking that everything that has a company name for it has to meet the strict FDA regulations regarding promotion because in news, you know, news is new, and a lot of news has to do with clinical trials that have just been completed. Clinical trials are done because people are looking for new uses of something.
MR. PINES: Mario, last comment on this and then we are going to move on to the SEC issues.
MR. CAVALLINI: This will be quick. Just to give you an idea of how slippery the Internet is, I would be tempted to say that, yes, having a URL of "bigbaddrugcompany.com" would give some indication, except that if somebody links into you and uses a frame to display the page that they're linking to, nobody is going to see the URL.
MR. PINES: I want to move on to the next general topic, which has to do with financial disclosure. I refer you to the questions posed by FDA, Question No. 2. ADF would like to use the Internet as the source for disseminating financial information and annual reports. I think a number of people here have already addressed that. ADF also would like to continuously update its annual report online to provide up-to-date information on its clinical development program. Is there a way to distinguish this information from information presented for a promotional purpose?
Al, do you want to begin that conversation?
MR. RUSCH: I'm from the SEC. I'll remain anonymous. I'd like to raise essentially three issues. Firstly, with respect to the particular hypothetical before you, it is not incumbent upon a publicly held corporation to update its annual report except in the following instances: any statement in the annual report is false or misleading at the time made; or, any subsequent material development required to be disclosed in a so-called periodic report.
Now, those of you who practice in the securities area know what that is. Namely, what we call a Form 8-K, which can be filed on a monthly basis and which has a laundry list of specific items of material developments that triggers the filing of an 8-K. A new investigational drug, surprisingly, is not one of those significant items. Something like bankruptcy, selling a subsidiary, acquiring a large corporation, things of that ilk.
Also, another periodic report is the so-called Form 10-Q. It's a quarterly report required to be filed every three months and must disclose material information with respect to the activities of the company. In that instance, as you might imagine, a material development could be the development of an investigational drug. So much for the hypothetical.
I wanted to raise an issue, if I may, that was raised by a member of the FDA panel about speaking on different sides of the tongue to different audiences. We at the SEC fervently believe that when publicly held corporations, including drug companies, speak to different audiences, that they must speak consistently. We have brought a case in the instance in which a publicly held corporation in its annual report with the SEC and to statements to investors reported, "We had a great year. Buy our stock. We're doing wonderfully well and we're going to do better next year."
Then, months later, in labor negotiations with its employee unions, guess what it said? "We had a terrible year, a disastrous year, and things are not looking good for the future." So regardless of the audience, it is incumbent upon a publicly held corporation to speak consistently and, hopefully, with comparable degrees of veracity.
Thirdly, and the last item I would like to bring to your attention, is our personal experience with respect to fraud that has taken place on the Internet and the unique circumstances that it presents for us at the SEC. We view Internet as any other form of communication, whether it's in print, orally, whether it's by public release or by access to the Internet. What the Internet does provide in the way of unique problems for us at the SEC is the instant potential worldwide access to any statement made by a public corporation. We have never had anything comparable to this form of communication before.
And the anonymity of the declarant. Now that, in turn, leads to another problem for us. That is, because of the anonymity of the declarant, the audience, and we at the SEC, don't know who's talking and the degree of authenticity of the declarant in that instance. Further sayeth I not.
MR. PINES: Anyone on the panel want to comment on the issue of financial reports, annual reports?
MR. REICHERTZ: I think right now it is obvious that a lot of companies who have homepages on the Internet have nothing but financial information on their homepages. A lot of companies don't even have product specific information on their homesites, so it is already being used for that purpose by a lot of companies.
I'm an FDA lawyer, not a securities lawyer, but following up on the last thing that was mentioned, I know that at least one of my clients has had a problem recently with regard to a short getting on chat rooms and talking down the value of the stock. So this is an issue that I think the SEC has to be concerned about. Obviously, when you can't find out who is doing it because of the nature of the URL, it makes it very difficult for you to deal with that.
MR. PINES: Let me ask the panel what the FDA is asking, which is a very specific question. Is there a way for our company, ADF, to distinguish information on the Internet from--that is financial information--information presented for promotional purposes? Two different purposes. That's the question that the FDA wants us to address.
MR. REICHERTZ: I probably should have been more specific. Normally you have different things that you can click on on a homepage and it is very clear to label those things in that way. Most of the companies who are on the Internet either will have something like "Financial News" or "Press Releases" or "Company Developments" that are clearly not product-oriented and they certainly can be distinguished in that way.
MR. HICKS: I think clearly that there can be multiple purposes for which information is put on the Internet. In fact, the clinical purpose makes an awful lot of sense. The informational purpose makes a lot of sense. But, invariably, a promotional aspect will result from putting information out there. Whenever you identify yourself, a promotion of sorts will result from that as well.
MS. CLEAVENGER: I agree with that. I believe that you can organize your site in such a way that information for investors is very clearly tagged as being that very message. They are also going to look at other areas within your site, some of which is going to talk about your pipeline, perhaps, and licensed products, et cetera. So, the information has to be consistent among the different sites. You may provide a different level of detail to the different audiences, though.
MR. PINES: Well, Al said that the information must be consistent. I think we are overall in agreement on that. Should there be different disclosure requirements for information directed at the financial community versus that directed at the consumer community versus that directed at the medical community or should the information virtually be--or be--identical?
MS. KELLY: I don't think that the information has to be identical, but if you are using a search engine, as several people have pointed out, you end up on the page where the information is. If I'm researching a new drug, lamivudine, I'm going to get those pages, not the context from which they sprang. I think it is just an illusion to think that you could package information differently--in such a way that the people who shouldn't be getting a certain message won't get it. I think that the idea that the information should be accurate and so on is the important thing.
MR. CAVALLINI: I'm fully in agreement with what Janis said. However, there is another step that can come in. That is, apart from not making the assumption that you can keep somebody from looking at something, you can provide information that specifically suits their needs. Thus, you can have an information disclosure page that will provide information that will satisfy the physician; another bringing in different terms, addressing different questions, that will satisfy the presumed needs of the consumer; another with different data, different language and such that will satisfy the needs of the investor.
MR. PINES: Just so long as it's all consistent?
MR. CAVALLINI: As long as the base data is the same.
MR. MERCHANT: I think the information can be distinguished, and to an extent I disagree with our previous commenters. Because the information that is in the button that's called "Financial News" or "Press Reports" is set in a context useful for the audience for which it is intended. It would be ludicrous to suggest in the annual report that one must include full prescribing information for every product mentioned in there. I think it's important to distinguish those contexts.
MR. PINES: Okay, so what you're saying is that if you are putting out information to the medical community, and perhaps to the consumer community, you need to have full disclosure, whereas something in an annual report, mention of a product and an indication, should not trigger full disclosure; is that correct?
MR. MERCHANT: I think that's correct in most contexts; yes.
MR. VANCE: That's also one of the balancing things about having your annual report on the homepage. If the person reads the annual report and then they want to find out for a marketed drug what, in fact, is its indication and stuff, that's all going to be elsewhere. On a related part of the homepage they can find that out.
Annual reports, for a big company, because it's not material for most drugs, we don't have 50 pages; we don't have five pages; we don't have a page; we don't have a half-page on most of our drugs. It's just a little reference. It may be that we are doing research on x approved drug for hepatitis, but that's all it's going to say. That's not where the information is. It's basically very superficial. It's, "We're doing research and we hope it will be there in a couple years."
But, if the person--we can't protect the idiot and I hope we won't go down to a dumb down to the lowest common denominator. If someone is seriously looking, hopefully they'll try to figure out, "What is the context that I've got this information on?" They're going to page up; they're going to page back. If they've come onto a certain word for one drug, they're going to go one paragraph and find out we're talking about another drug, down two paragraphs, we're talking about a different drug and they're going to go someplace else to get other information. Hopefully they are not just relying on our homepage to begin with.
DR. WOLFE: Whereas I would agree that the full labeling doesn't need to be disclosed when someone puts up their annual report, on the other hand, the kind of overstated and, I think, misleading statement that I read from the mouth of the president of a drug company given to stock analysts could be put in a similar form in an annual report under the paragraph or so that there is for that drug.
As such, even though we wouldn't want to require full labeling--let's say it's an unapproved drug--that should be subject to false and misleading. The company is just as capable of engaging in false and misleading promotion through the annual report as they are through a presentation to a stock analyst or through regular ads. So I think we can distinguish elements of the annual report.
MR. VANCE: I would hope FDA would take action against a company that hypes their drug with misleading statements in an annual report or in a press release. We are very careful when we are talking about investigational data to make very clear that it is preliminary: it may suggest something; the number of patients; and make absolutely clear that the adverse events are there.
Yes, we want people to know that there may be some hope. There is some drug in development for a certain area, if there is something significantly newsworthy, and we are very careful about that and we have had generally very good relationships with FDA on making sure our press releases on investigational stuff are responsible so that the patient population, physicians out there, can know what is going on in an area.
MR. PINES: Let me ask you a question, to the companies here who might put information in their annual reports. Let's say that you've reported in your recent annual report that Drug X is being investigated for Indications Y and Z and you find out today, right while the annual report is in the mail, that the clinical studies on Z have fallen through and that's not an indication that you're going to pursue anymore.
Is that something that causes you concern? How do you fix that? How do you deal with that? You are going to have an annual report that is going to be alive for a year which is essentially going to have misinformation. Let me ask Dave and anybody else who wants to comment on it. Becky and Pam; and Pam will have the final word and then we are going to break for coffee.
MR. VANCE: I think there are liability reasons why generally if something goes significantly wrong, you lose an indication or whatever, you would already issue a press release. I've been involved in press releases on Flolan for congestive heart failure where we had to stop the study because it was, unfortunately, killing patients, to our absolute incredible surprise, although it saved lives in other indications. I've been involved in recalls of drugs. So I think if it is significant, we have possible SEC reasons and liability reasons--
MR. PINES: Well, Glaxo Wellcome has very little that occurs to one drug that is material to the company. Are you suggesting that there should be a requirement from SEC or from FDA that if you have announced that you are investigating Drug X for Indication Z and it falls through and you are no longer doing it that you should be required to issue that press release?
MR. RUSCH: I'm waiting.
MR. VANCE: I'm a patient activist and medical attorney, FDA law, not in securities law. It's been a long time ago.
MS. CLEAVENGER: I want to address the press release issue, but I think there are so many things you can do with the Internet. If you have information in your annual report that is incorrect, you can add a hyperlink. You can put new information. You can put "important new information" and have a hyperlink that says, you either link to a press release if you've issued a press release or you put a statement in there that says we are no longer pursuing this indication because of x, y and z.
MR. PINES: Pam, you have the last word and then we'll break for coffee. Since everybody is going to stand up as soon as Pam speaks, I'll just say it now. We're going to break for 20 minutes. Be back in your seats in 20 minutes and we're going to pick up with the additional questions.
MS. WEAGRAFF: I think it's very short and sweet. I concur with both of the previous comments. Simply as quickly as possible, depending on the severity of the situation, correcting the statement that is potentially misleading out there.
MR. PINES: We're going to start, if everybody could please sit down.
I'm going to start in with the third question right away. We have a few things left to be done in the next hour or so. I want to get to the third question which deals with clinical trial recruitment. We're going to have an opportunity for people from the audience to have their two-minute say at the microphone. And, there are only two microphones so I'm going to ask when that time comes to line up and please restrict your comments to two minutes. We're going to have more time for FDA to question the panel and then we'll perhaps have some wrap-up.
So let's go to Question No. 3, or Issue No. 3. Let me pose it to the panel and ask for their reaction. ADF wants to use the Internet to recruit clinical investigators and patients for clinical trials. ADF would like to describe the protocols for the planned studies in some detail. Is there any utility to using the Internet for this purpose given the geographical widespread nature of the Internet audience and how can this information be presented in a nonpromotional context?
Who wants to comment on that? Let me get a few hands. Okay, we have five commenters to begin with on this question. Priya, why don't you go ahead and begin.
MS. JAMBHEKAR: I really think that is the best use of the Internet, to provide this type of information which is available right now in print or in radio or on television, to provide information so that you can recruit patients. A lot of companies are also using the central recruiting facilities. I think this would assist further in facilitating the trial and providing the information.
A couple concerns I have are for the products which are already approved and out there in the market and you are going for a new indication. The drug is out there, you're providing information; is there a danger, more than what we have now, of product being misused because more people will know about that? And will people want to try something because they had a prescription for something else and whatever they heard seems close enough that they may just want to go and try? Is that potential there?
MR. KUROMIYA: As a participant in a number of clinical trials, in fact that was one way of accessing drugs in development during the early years of the epidemic and this continues. We find it very important to get all the detailed information to put it in proper context. That's why we've made an effort over the years to publish full clinical trial protocols. It's very easy to publish text 80 or 120 pages long on the Internet and provide people who are considering entering the clinical trial to have the full clinical trial protocol information.
We also think it is important to share this around the world with individuals who may not have as much access to experimental drugs so that they can be helped in their advocacy efforts. We, also, are in accordance with the Office of AIDS Research recommendations that there be more coordination within AIDS research. We are linking the community advisory board panels of the clinical trials networks and the advisory panels for pharmaceutical industry trials to share information and develop more coordinated clinical research.
MR. MERCHANT: I think it is appropriate to provide some detail to the protocols on the Internet. It's not clear how much ADF client wants to disclose in this case. But it seems appropriate to disclose enough information to allow a potential study subject to decide whether to seek further information and that information that is given to the potential study subject probably should not have any promises of efficacy but may want to include or disclose the exclusion criteria so that it can limit its responses to an audience that is likely to be eligible for participation.
MR. REICHERTZ: With regard to the geographical issue, I think that you've got different potential scenarios here. First of all, if you're investigating a product and say it's got six sites, you just have to say the sites where the thing is being studied and then people who access the site who are in that area can find out information on it.
But you've also got situations too where you have products that, for example, are treatment INDs or orphan drugs that, perhaps, are done under different types of INDs. I think that, certainly, in that sense, the Internet makes it much easier for people to get information about that where it may not be being done in their local areas.
MR. WHITAKER: In terms of the utility of using the Internet for reaching out to patients, we get 30,000 visits a month from patients. They really are starting to see the Internet as a way to gain, as you said, access to promising new drugs. They really view it as a right in terms of as they consider their options. These are people with chronic diseases, et cetera. So I think as the FDA considers this, it is the patients out there really want this information. It's a great use of the Internet.
In terms of presenting it in a nonpromotional manner, again, I urge the FDA to consider if a sponsor is putting it up on its homepage, it is the same thing as if they placed an advertisement. It should be an IRB-approved reaching out to the patient. I think that's the safeguard here in terms of making sure it's not too promotional.
DR. WOLFE: If you read the Health section of The Washington Post or other places, you'll see ads recruiting patients for clinical trials on drugs. Never will they reveal the identity of the company that's doing it. It's the investigators--Georgetown Medical Center, whatever. So I think the identity is important.
The reason why we strongly opposed the legislation that would have allowed promotion of unapproved uses was that the selective ability, the ability to selectively promote by a company a published study that said this drug is terrific is an imbalance in itself and can mislead people to demand of the doctor or the doctors to write prescriptions for it.
I think that if in a balanced fashion--with not all of the information because the companies don't want it, as was pointed out--with at least the benefits, the risk, the fact that it's not approved, that we do not know a, b, c, I think it is not going to be that difficult to distinguish promotional, misleading, out-of-context information from the kind of thing that would and should constitute an informed consent sheet or some facsimile thereof.
MR. PINES: Let me ask a question. Should there be a distinction in terms of the way that information is put on the Internet to recruit for clinical trials between a drug that is already on the market and is being tested for additional indications versus a drug that is not available on the market, to raise Priya's concern about off-label promotion, which is essentially your concern and I'm sure the people over here are thinking is also a concern.
Should there be two different ways to do it--one for a drug that is not on the market and one for a drug which is being tested for new indications?
DR. WOLFE: I think the answer is yes because for the drug that is on the market for one purpose, unless it is clear that there is not adequate evidence yet to affirm the safety and efficacy for the second purpose, the person might simply say, "Aha, this drug is already good for Disease A. I'm now going to go to my doctor and try to get it for Disease B" and there is absolutely nothing to stop a doctor from prescribing it for the unapproved use. So I think that it is easier for it to fall into a promotional context, obviously, if the drug is on the market. So it does have to be distinguished.
MS. KELLY: My concern is sort of parallel to Sidney's. I think that the big difference is that anything that's on the market has at least generated some kind of safety data and a track record. If a drug is not marketed for anything, we have no way of knowing whether that's true or not. I think that should be made clear if it's a totally new drug.
MR. VANCE: I think the answer depends on where the drug is. We actually right now are dealing with a patient group for a drug. We just signed off on trying to help them let members know of a fatal disease. The drug is approved for one indication that is similar but we put in expressly that the drug is investigational for this use and in some patient groups it is detrimental. In fact it, in one patient group, hurt people. That is expressly in the materials that are possibly sent out by this patient group to let their patients know.
MS. WEAGRAFF: To put the question into a device context, certainly, if the device is investigational, the advertising that would be reviewed and approved by an IRB, whether the IRB is in an institution or a commercial IRB, would include a statement as to who the sponsor of the clinical study was, and that would be very clear in terms of the manufacturer.
For an off-label intended use for the device that would still be considered investigational, we would still be sure that that advertising was subject to the same type of IRB review and approval and in that advertising most likely it would state that the intended use that is cleared and available is A versus B, the investigational off-label intended use, which is the subject of that clinical study.
MR. PINES: One final question on that clinical recruitment. Should there be any distinction in the rules that apply to clinical recruitment generally, the way it's done right now, versus the way that you would use the Internet for that purpose? What is different about the Internet with regard to clinical recruitment? The FDA has said in this question you obviously are reaching a wider audience. If you are advertising in The Washington Post, you are reaching a particular audience where the trial is being conducted. You can put the same notice on the Internet and you reach people all over the world. Should there be a distinction--
DR. WOLFE: But it doesn't say the name of the drug or the name of the company in the Post ad.
MR. PINES: Right; but should there be a distinction between the rules that apply to the Internet versus those that apply--the current rules that are much more focussed. Again, let me get a few responders. Bob and Kiyoshi and Mario.
MR. WHITAKER: No; I don't think there should be any distinction. It's a way of reaching out to patients and whatever safeguards you have to make sure it's a nonpromotional manner if it's coming from the sponsors those safeguards should be the same. I don't see the distinction at all. It's just a medium with a great power to reach people.
MR. KUROMIYA: I think that the Internet should be a free marketplace of information. I think one of the most useful aspects of the Internet for patients with AIDS, to give one example, is the fact that we can share information on personal experiences regarding off-label uses, combinations that have not yet been tested, alternative and complementary therapies in wide use in the community and situations for which it is difficult to otherwise get information. We can share information through such media as, to give several examples, Crixivan, mailing lists, Cymed AIDS, Cymed Nutrition, the Vancouver mailing list, which we host, and a number of other discussion areas.
MR. CAVALLINI: I never thought I would say this, and somebody is going to prove me wrong on it, but in this instance the Internet is just like any other medium. You're getting the word out and the candidate is going to make contact with the people conducting the study. From that point on, it's just like the other mechanisms.
MR. PINES: I'd now like to turn to the audience.
MR. SCHULTZ: No. Let's do FDA.
MR. PINES: Okay; I don't want to turn to the audience.
MR. SCHULTZ: We've got a couple of questions. Let me just ask a question to follow up on something that Wayne Pines was raising. In terms of an approved drug, where an additional unapproved use is being explored, it is very clear that if you separate the world into drug companies and everybody else that everybody else can be very free in terms of exchanging information, whether it is on the Internet or somewhere else. Whether you are talking about a medical journal, a patient group, a writer, the rules are very open and we don't really get involved.
The issue comes when a drug company or a device company is distributing the information. Today if the drug company proactively sends out, for example, scientific journal articles about unapproved uses of drugs, that would be a violation that we would treat really as promotion. On the other hand, if a physician or a patient asks for a copy of an article and they know what it is, the company is free to send it out.
The Internet, I think, seems to fall somewhere in between. I would just be interested in the views of the people on the panel or any preliminary thinking as to what the rules ought to be in that situation.
MR. PINES: Who wants to comment on that? Pam, Pat, Tom, Janis and Lou. Okay; we've got five comments here.
MS. WEAGRAFF: I believe this morning I did make the comment as to the proactive distribution of scientific literature versus providing it upon request. In terms of the Internet, I don't see it as being somewhere in between because someone who is going through the Internet is actively seeking information. The Internet is not easily navigable at this point in time. People who are actively seeking that information are as actively seeking that information as somebody picking up a telephone, making a call to me at Hewlett Packard and saying, "I understand that Physician X, Y, Z has been involved in a clinical study using your device. Could you please send me a copy of that article."
MS. SHRADER: I think that the rules shouldn't be different. What I do think that the Internet does provide is maybe an easier mechanism in the sense of possibly reaching a broader audience. You know, people may be less inclined to pick up the telephone and call the company and more inclined to sit in the comfort of their den and look for this information. But I don't think that that necessitates any kind of different rule for how companies would handle the information or the kind of information they would make available.
MR. MERCHANT: I think there is a potential for abuse here with approved drugs. An extreme example is one might have an approved drug being studied in New York City for a new indication and put a notice on the Internet that this new indication is being studied. It's now picked up by someone in San Diego, or anywhere else in the nation, who then goes to their physician and demands a prescription for the product for that new indication.
I think that type of abuse of the system can be reasonably controlled by the prominent use of disclosure of geographical limits in connection with that solicitation to identify where the study sites are right up front so that the reader who is interested in that drug may not read any further once they see that the study site is only a thousand miles away from their home.
MR. SCHULTZ: But if it's not a study site, it's just a journal article about an unapproved use, what do you think the rules ought to be there, as to whether companies ought to be able to or in what circumstances put journal articles on the Internet.
MR. MERCHANT: Journal articles on the Internet for unapproved uses generally should not be on a company's product site or homepage. However, I think it is appropriate to allow links, which are going to be the subject of another discussion group, to databases that may contain journal articles of that type, provided they also contain on-label articles.
MS. KELLY: I wasn't aware that you were specifically talking about journal articles as opposed to investigational protocols. But I think the fact is that not only are people actively seeking information who are on the Internet, but people who get information via the Internet have much more ability to double check that because they have access to information on all of the investigational drugs and devices from other sources and so, in that sense, are less vulnerable than somebody who might just pick up a notice out of The Washington Post.
But with regard to the journal articles, I guess I don't think they should be on the company Web page either, but the question of whether a company can link to The New England Journal, you know.
MR. PINES: Okay; we're going to deal with linkages, I think, this afternoon.
DR. CASTELLI: I think in terms of the technical aspect is that what separates is the request factor, and I think you were mentioning earlier was the request factor. There are steps that anyone on the Web can take, such as E-mailing requests. You can certainly have the person, if you don't think it should be up there for general publication, that the individual user can E-mail requests.
To the degree that you want to monitor who is requesting, and you can certainly ask for information such as name, address and everything else that you want and then immediately, electronically, the person could receive it electronically as well. So if the distinction is the fact that it is requested versus proactively sent out and published, E-mailing is a very easy, simple mechanism to solve that.
So it's taking the step that I think Pam was saying earlier; that is, not only a kind of a passive request by just your presence, but it is an active request and it just puts it two more steps up there.
DR. WOLFE: I agree. I think the problem is that if the company that is talking about this unapproved use selectively picks up one journal article and makes it available on the Internet, then you are getting rid of the step that you suggested, which is the active request. I think that then falls in the same category as the selective sending out of articles on unapproved use by companies.
MR. WILLER: The issue again, whether it is off-label or not, is how does the company connect fair balance kind of information to these requests. That's one we still have to look into, I think.
MR. SCHULTZ: Jerry Donlon has a question and then Lou Morris may have a question.
DR. DONLON: I have a specific three-part question for Robert Whitaker. In your services that you provide through the Internet regarding investigational clinical trials availabilities, the three-part question. First of all, who develops text for that? Who develops the information database? Does that include a copy or assimilation of the informed consent? Well, that's it; those two questions basically.
MR. WHITAKER: Yeah; the text is very straightforward. The text is either given to us by the sponsor, along with contact information for each of the research centers, or some of the postings come from the research centers themselves. So that's why we view it in essence as an ad. I mean, it's coming from the sponsor or the research center. And that's different from where you have a group, like an AIDS group, et cetera, generating this information, in that it is generated by the pharmaceutical company. That's why given that it's coming from that distribution, we felt it should go through an IRB process in order that patients were getting sort of nonpromotional material.
In terms of informed consent, no; there's no informed consent form on our site.
DR. DONLON: Do you review that text for fair balance? Do you have any information about, for example, the adverse events and other conditions that might be--
MR. WHITAKER: We do not. We consider our role as a publisher and as a neutral publisher. We don't own the study, obviously. We don't get any benefit, in fact, if patients do enroll. But we consider ourselves as a publisher, the same way The Washington Post is. We took the extra step though, really out of what we felt was obligation to the patients coming on because we are really not in a capacity to review it, whether in fact it is fair or nonpromotional. We said let's let the IRB do that. So we asked for a stamp saying that an IRB has seen this text.
So that's how we handle this potential pitfall. But we're not the one, really, I think, to review it for fair balance.
DR. BERNSTEIN: Many of you have said that context is important in determining whether something is promotional or nonpromotional. To Lou's question earlier, a lot of you answered that some sort of disclosure is important. But given that, like in ads you see that little teeny word "advertisement" at the bottom and that if you do a search of a Website and you get to a location, you may be right in the middle of a document. Can a couple of you comment on what type of disclosure would be considered adequate on a Website for information?
MR. VANCE: A lot of this has to do, I guess, with the technology. One thing that wasn't talked about this morning was screen size, monitor size. If you have a very good monitor, you might be able to see more; if you have a very little monitor, you will see less. If you have five windows open at one time, you may have a very big monitor and you might actually see something one word at a time. You don't have to download the graphics if you don't want to. There are lots and lots of issues.
One hypothetical, when Panel 3 met last night, was what if you have a 37-page document, how often do you have to have a product link? Well, who is going to read a 37-page document? We spend a lot of time and money making sure that our materials, either whether patient education or physician promotion, are crisp, focussed and that people will want to read them. Otherwise, they won't come back. They won't stay. They'll go someplace else.
So I think it's more likely than not that you're going to have segments; you're going to have tables of contents. Somebody that really cares enough will go up high enough or low enough that at the beginning or the end they are going to see a copyright notice, they are going to see if it is product-specific, they are going to see a reference to product information. The chance of someone, unless they really are surfing the Internet, rather than studying something, they should see enough, if you're responsible. I think the responsible companies probably will have "U.S. consumer" or "U.S. healthcare professional" on it.
MR. MERCHANT: I think oftentimes the context will in itself provide a disclosure. When you are in the financial section of a company homepage, it is fairly obvious to even unsophisticated readers that they are reading company financial information in most cases. When you are in a section that is soliciting volunteers for clinical studies, the words that are used to solicit those volunteers provide context and disclosure that is often adequate.
I think it's impractical for FDA to force disclosure of a company name on every page or every screen in a company Website, but it should be readily available; it should be obvious within a reasonable search within the document you are in that the information is coming from an FDA-regulated company.
MR. HICKS: The whole notion of disclosure is something that the state AGs have been very, very heavily involved in discussion with most of the online services: AOL, Compuserv, Prodigy and those kinds of folks. When you disclose as well as what you disclose are both separate topics for discussion. Depending on the content of the message, sometimes it seems appropriate for the disclosure to happen at the outset before you even get into the content of the message.
In other instances, it seems appropriate for disclosure to happen throughout the message and in other instances we've even talked about a disclosure that pops up and goes away by clicking an "Okay" at the bottom. I know a number of services actually provide a disclosure at the very beginning of a content message that you can read or not read and make it go away. One of the things we've discovered, though, from a marketing point of view, is that consumers generally don't like those screens popping up. So we've sort of evolved to disclosure within the content of the message as the most appropriate mechanism for people to understand where the message is coming from.
MR. CAVALLINI: I'm not an attorney, but I've noticed that in certain situations it's useful to have a reasonable "so-and-so" standard: reasonable consumer, reasonable provider. I think this is one of those instances where we have to try and imagine a reasonable browser or a reasonable visitor to a site. I think the reasonable visitor has a right to expect to see on that page and on each and every page the authorship of the page, the aegis under which the page is being presented. If it's a company page, the company name ought to be there.
For other sorts of information, such as an extended drug disclosure, there should be a link off of that page. It doesn't necessarily need to be on the page, but a reasonable user of the Web would follow links.
MS. JAMBHEKAR: I agree with him that basically I think disclosure should be there for the information that requires a disclosure. And, it should be prominently displayed, either as a header or a footer or somewhere you can click throughout the text or display it as the text is being read or seen so that the information is understood to be what it is.
DR. CASTELLI: Just, I guess, a brief note to make us aware of the fact, or make you aware of the fact, that any regulation that you may pass concerning any requirements on any text is only for the originator of the document the first time. Someone else can indeed take, and does take, portions of those texts. Since the copyright law does not govern the Internet, I can take any text, take it out of context, put it somewhere else, link it and provide it as information. This is just a by-the-way thought.
So no matter how many precautions may be taken by the originators in terms of disclaimers and clarifications and caveats, that information can always be taken by somebody else and provided out of that context.
MR. PINES: How many members of the audience are going to want to come to the mike? Just raise your hands.
Okay; not that many. There are two mikes, two minutes apiece. Why don't you start lining up and we'll just alternate microphones and let's make sure we have enough time for everybody. I think we will if everybody limits themselves to--it's getting longer and longer--a minute forty-seven I think would do it. Go ahead.
MR. REID: Ken Reid with the Medical Device Approval Letter. I just wanted to correct what this gentleman just said. Copyright law does apply to the Internet. I'm a newsletter publisher.
I'll sit down. I just wanted to make that correction. Thank you.
DR. STEIN: Dr. Sara Stein from Stanford University Department of Psychiatry. I have three separate points. One is just in the discussion of search engines, I'm not sure if people are aware that in one particular search engine--this was in The San Francisco Chronicle just three days ago--in open-text index the first ten hits on any search are determined by advertiser fees. So that's important to know.
Number two is there is a technique in Adobe Photo Shop called a watermark, which is basically a wallpaper which enables the company logo to be on every inch of the page so that even if someone lifts a paragraph onto their own page they will still lift the logo.
Number three, as a psychiatrist I would be remiss in my duties if I did not underscore the vulnerability of sick people who are searching for information at a time when they are overwhelmed, particularly when it comes to clinical trials. So I would urge the FDA to please make sure that they put exclusion and inclusion criteria very clearly since there are extremely rigorous geographical criteria, and particularly in the use of medical devices, where a person may not be able to get the newest balloon angioplasty in their HMO because it isn't free, it isn't cost-covered, to put disclaimers on what really is available to the average person in various locations of the country. Thank you.
MR. SCOTT: Mike Scott, CoMed Communications. One of the things that I would ask if we could all consider during the course of today, and that the FDA in particular would think about during its deliberations, is that this is a technology which is basically an infant. It is barely crawling. If you start to put regulations on this infant at an early stage, we are going to profoundly stunt its growth potentially and we may not see some of the best things that become possible out of it. I would encourage everybody to consider that as a very important part of what we are thinking about today. Thank you.
MS. TODD: Leslie Todd, Vivus, Inc. I wanted to clarify a technical point about context on pages. It is technically possible to organize your page so that no matter what search someone does, no matter how they get to your page, you can control what page they see first. It's not necessarily the nicest organization for the viewer by any means, but it is possible to make sure they get to a disclaimer or to a particular page first simply by making everything on one page, which means you'll have 37 pages worth of information that they have to scroll through. But it is possible. Thanks.
MR. CHEM: Tom Chem with Genetics Institute. I think one of the things that you want to keep in mind over the next two days is that ultimately the FDA is here to protect the consumer, the patient, from any harm through a drug. Ultimately, the consumer can have all the good information or bad information from the Internet but ultimately the person who is prescribing the product is a physician. I think the informed patient is the best patient for their own selves and for the physician's best interest also. So that's something I want to bring up.
MS. BUCKLEY: Toni Buckley, with Harris, Baio, McCullough, a public relations and advertising agency working very closely with the pharmaceutical industry. I actually wanted to underscore the point that was just made that ultimately the prescriber, the healthcare professional, is the one who makes the decision to prescribe a drug that information may be accessed about on the Internet.
But I would like to further that by saying that it's so important for--we shouldn't assume that all consumers are unsophisticated, although it's important to protect those who are. But what is important about this opportunity for patients to get more information, I think it also fosters education as far as the professional healthcare provider is concerned as well because when more patients start asking more questions I think it is incumbent upon the physicians and the healthcare professionals to make sure that they are educated to respond to these questions.
So I think it is important in our consideration of the Internet that we do realize that, regardless of what is out there, ultimately that consumer needs to go to a healthcare professional to get any kind of a prescribed drug.
MR. CAMCOWICH: My name is Bill Camcowich. I'm publisher of Medicine Online. I think an important advance has been made this morning. That advance, it seems to me, is that there was consensus that limiting access to the Internet is a non-starter, that you simply cannot limit access to the Internet for either professionals or consumers. That seemed to be fairly well agreed throughout the discussion.
A point about that is that if you don't limit access, the Internet gives you the opportunity to layer information so that an easier piece of information for a consumer can be put on top of a professional piece of information, an interpretive piece, where the consumer can clarify the deeper professional information that is there for the healthcare professional.
And to go to the point, a question was raised by an FDA panel member about distinguishing between advertising and education within the Internet, that you can do that in a publishing media but you can't do that in the Internet so well. In the publishing media, we've had 200 years to set up conventions of what distinguishes advertising from editorial content and we are just now building those kinds of conventions in the Internet; we're building those kinds of vocabulary and syntax that everyone will come to learn.
I would emphasize what a previous speaker said of let's not stifle innovation with regulation. I think it is very important to give this technology the opportunity to grow and to let people tinker, if you will, in order to find the best way to do things for everyone's benefit.
MR. LOPEZ: Jorge Lopez from Sepracore. I have a couple of points. This morning most of the people have talked about textual information. Just be aware that five, ten years from now, it's not going to be text; it's going to be video. So when you draw your guidelines, you have to consider the fact that it's not going to be just letters coming through the screen in the very near future.
The other point that I wanted to make is that because this is indeed a "worldwide web", any restrictions that are put on the industry may eventually end up benefitting the private investor. I can think of a scenario where a stockholder in a company or a private investor, small investor, knows information about off-label uses and even though the company is restricted from placing that information on the Internet, that person may provide all the journal references to off-label uses. He may benefit indirectly by having people go to their doctors and asking for that particular prescription.
The industry needs to be able to somehow have some sort of control of that. If you completely take away the control of that kind of information, or restrict it, someone else is going to benefit heavily from it, and most likely in a non-beneficial manner for the patients.
DR. MERRILL: I'm Dr. Merrill. I'm on the faculty at the George Washington University Medical Center and also the CEO of Medical Consumer Media, which is a company focussed on consumer health education on the Internet. One of the things that I would just like to bring up, we've been talking about regulations on the Internet but we have one problem in the U.S. That is compliance. There are a lot of studies that show that 40 to 50 percent of patients don't take their medications.
If you look at the PIs on a lot of the products, it's very frightening, even for the most commonplace medications, for a number of patients when they read this information, in magazines, in Parade, in The Washington Post. It's frightening to look at some of these things for patients.
One of the things that we should think about is not the addition of additional regulations and additional information that could impede the people making decisions and furthering our lack of compliance with medications but rather to look on the other side and maybe for the FDA to actually reward or give brownie points in some way to companies that provide information that can help patients make better informed decisions.
So, you know, we have a lot of regulations in place. We have a lot of information that's out there. A lot of people aren't using it in a way that's constructive. So I just would like to look at the other side of the equation too.
MR. MACK: My name is John Mack. I'm Webmaster at Pharm Infonet. I think you're going to be in trouble trying to regulate the industry of the Internet if you are just thinking about today because six months from now it could be a completely different place. For example, in terms of the context and limiting the audience, it's technically possible, and you can already see this happening, where if you profile yourself as a user, you want to receive just certain information, your Web server can serve that information up that is tailored specifically for you.
For example, if you define yourself as a patient, then the server can give you patient-oriented information. It's not a matter of you browsing anymore because that's a very inefficient way of getting information. So basically I think you need to think of what's going to happen with the technology in the future, maybe a year down the line from now, and then maybe your regulations might catch up to the Internet.
MR. KLOFF: Thanks, I snuck in at the end here. Bob Kloff, Tri-Clinica Communications. We're the med-ed division of Low, McAdams Healthcare in New York. My comment is just something by way of information. With copyright and liability, in case someone takes information from your site and uses it out of context on another, the American Association of Advertising Agencies has created two disclaimers--one is a very legal type thing; the other one is a very informal, almost fun to read kind of a thing--which they make available to anybody who wants to take it and use it. They assign the copyright for use of it. You can get it from them in New York.
We've used them on several of our Websites and clients' Websites. It just saves a lot of trouble of you trying to create your own disclaimer in terms of where liability lies and such.
MR. PINES: I want to wrap up by giving the panel an opportunity to make final comments. I know you've enjoyed your two minutes, but this is going to have to be in about 45 seconds each. Then we are going to break for lunch.
The question that I want to pose to the panel is you have the FDA staff sitting here before you. They are developing a policy on the Internet. You have less than a minute to tell them one basic message that you're concerned about, that you want to see included in the policy, that you don't want to see in the policy. What is your basic message to the FDA? I'd just like to go around the room and, again, I ask you to limit it to the half a minute, 45 seconds; one basic message.
Sid, you want to start over here? We'll go in inverse alphabetical order.
DR. WOLFE: The panel's charge, despite what the conversation has been, has been on investigational drugs and the pipeline. Most of the comments are general comments. I think that's fine. I will make a general comment to the FDA which is: A) we really do need to have regulations on direct-to-consumer advertising; and, B) we have to have much more enforcement of existing regulations.
In an article that will be published in the next couple of weeks in the Journal of General Internal Medicine, in one place, San Francisco, they were easily able to find 17 examples of unapproved uses of drugs being promoted by drug detail people. I'm not aware that there is very much enforcement of that. That's what the topic is here and it's going to be worse on the Internet if it's allowed to happen.
MR. WILLER: I would ask the Agency to consider most clearly on how we link fair balance or insert similar full-disclosure information to a Website or to a promotional piece or to an informational piece so that if it's a multiple document in a file you only want to put the full-disclosure information in there once. How do we link all that together? That's a bit of a conundrum for us.
MR. WHITAKER: I just want to say the use of the Internet to inform patients about clinical trials is a great development. It's really wonderful for patients in terms of getting information that can, in fact, help them with their chronic diseases. I would just urge the FDA in terms of when that information comes from sponsors and research centers that it ask that it be done in the same sort of nonpromotional way that they reach out to patients in other traditional mediums.
MS. WEAGRAFF: I would emphasize also, specifically for investigational devices or drugs, that there are regulations in place regarding the promotion or the prohibition of promotion of investigational devices. The advertising is supposed to be going through IRB review and approval for the recruitment of patients to protect the patients, especially vulnerable populations. That those regulations are in place, they apply whether the advertising is in printed form or is available to patient populations or others via the Internet.
MR. VANCE: I still am inclined to think that the regulations are basically good as are. There are, as Dr. Willer suggested, some areas on direct-to-consumer that could be clarified. I think the AARP suggestions of a very brief disclaimer for TV and other broadcast is great. Internet we can do much more on.
There was an excellent suggestion from the audience about highlighting the stuff that's right. This was used recently at the Food Drug Law Institute on the reprint policy. I think perhaps FDA should say, "Here are companies that have been doing things right. This appears to be appropriate disclosure in an annual report. This appears to be an appropriate way of doing notices about clinical trials." That may be a better way of sending a positive message out.
MS. SHRADER: I hope that repetition is a good form of reinforcement, because I think what I'm going to say pretty much repeats what everyone else has said. I would encourage FDA, in thinking about regulating information on investigational products on the Internet to try to keep in mind that most companies try to do a good job and try to meet regulatory requirements. I think if you regulate with that in mind that we can provide the greatest possible benefit to users of the information.
At the same time, I would encourage you not to try to regulate things that companies can't control, which is other people's use of our information. Finally, to echo Sid Wolfe, do enforce against the bad guys. It does provide an incentive to continue to be good guys and makes it clear to them what they are doing that isn't acceptable.
MR. RUSCH: This is the SEC, and to my brother regulators I'd like to point out three situations in which we have specific regulations. We are considered, more or less, the experts on disclosure. One situation involves what I would characterize as "the gag rule" with respect to gun jumping. That is to say situations before a public offering becomes effective, we prohibit any written communications before the SEC declares a securities offering effective.
Secondly, the paramount link throughout the security laws is one of disclosure, and of material disclosure in particular. Materiality has been defined by the courts as that information that a reasonable investor would consider important in whether to buy or sell a particular security. Obviously you can translate that and put that into the context of a reasonable patient.
The third is that in the instance of materially false or misleading statements, effective enforcement is perhaps the best policeman on the block.
MR. REICHERTZ: As a third party, I only have this comment with regard to these issues. I think that the industry, as has been stated, is generally responsible and as much as anything looking to hear from you on this issue. They haven't heard very much, particularly from the Center for Drugs. They've heard a little bit more from the Center for Devices about how they are going to handle these things. I think the sooner that you say something, the less problems you're going to have.
MR. MERCHANT: I would urge FDA to recognize that not all materials on the Website are promotional and that due consideration should be given to the content and the context and the intended audience.
MR. KUROMIYA: I'm a participant in a number of patient discussion groups, both Newsnet news groups, such as Cymed AIDS and list serves such as the Crixivan mailing list. We insist, in an informal way, on disclosure for both pharmaceutical company representatives who participate in the discussions and FDA officials.
MS. KELLY: I would urge the FDA to bear in mind the need to encourage, rather than impede, the exchange of useful clinical information, both among professionals and in situations where patients need information. My nightmare is that some rulemaking might come out of the FDA that has a chilling effect on this kind of information exchange, similar to the Ingelfinger rule, which is my other nightmare as a journalist.
MS. JAMBHEKAR: I'm going to echo what most of the people already have said. I think there are regulations for the print material today and they should be applied to the Internet. There are sufficient regulations to provide information on the investigational uses of the product without going into the promotional matter and that should be continued whether it is Internet or it's not.
MR. HICKS: I principally wanted to commend the FDA for having this forum because I think it is, probably, the beginning of the real important thinking process on this subject. However, I also want to make you aware that you should not think about regulation in isolation because there are other people engaged in this very same dialogue.
The Federal Trade Commission, for example, is very actively reviewing how they might regulate advertising. The Securities and Exchange Commission, obviously, is also thinking about how they deal with these issues. On the state level, there are at least 39 states working with the FTC and others engaged in the same dialogue. So I urge you to connect so that you don't duplicate your activities.
MS. ESKIN: I just wanted to echo a couple points. One is that obviously the Agency knows that it is charged with prohibiting false and misleading information. That information can appear on a newspaper, in a printed form, it can appear on a television screen, it can appear on the Internet, on a computer screen. I think that has to be kept in mind here.
In that way, perhaps, the technology isn't so important and the other rules that have been developed would be equally applicable. Obviously, the Internet has a tremendous educational potential. That is, again, what also the Agency should keep in mind and ways to ensure that that educational value is maximized.
I think, particularly in the area of investigational use drugs and devices, we've talked a little bit about disclosure requirements, disclaimers, whatever, ways to let consumers know when they enter a document that, in fact, the particular use that's being discussed has not been approved. I still agree that is--or at least believe that is--an approach that needs to be considered and hopefully will evolve.
MS. CLEAVENGER: I would like to encourage you to keep in mind that the different audiences that are going to be accessing these sites have very different needs for the level of detail in the information they are trying to acquire. When writing your policy statement, I would just keep that in mind.
MR. CAVALLINI: I would encourage the FDA to keep in mind that this is a different playing field than we have been in before. When you look at traditional medical journals, it's pretty obvious that pharmaceutical companies and device manufacturers have greater practical access to running advertisements than other parties. When it comes to Websites, however, any consumer can put up a Website, any institution, any party at all, with much greater parity. To regulate one of the players, the pharmaceutical manufacturers, would put them at a disadvantage if the others are not similarly impeded.
The other problem that the FDA would face in trying to regulate Internet behavior is that the Internet is continually evolving, fast, in various directions. Whatever regulations you try to come up with, they are going to be behind the curve. Thus, the basic message would be, don't regulate; participate. Come up with voluntary standards that people can comply with, for instance.
DR. CASTELLI: One of the things with being one of the last individuals is that I have very little to say. It's been said already. Except I would like to thank the gentleman for the clarification on the copyright issue, that there are issues. My statement was more that there are issues that are very complex on the Net, not necessarily that the laws do not apply. Thank you for that.
But there were two things. One of them, to echo what Mario said very, very strongly, is that any regulation that you think of doing, and preferably not do, has to deal with the fast change of technology. We are right now, and we have seriously spent most of the morning, talking about the Internet as it is frozen in time at this moment in its present use. We haven't talked about interactivity; about the fact that telecommunications and entertainment are going to jump on and converge on it and all of a sudden you are going to have interactive video communication. How do you begin to regulate that?
So any regulation that I think you even consider has to take the very near future--we're now talking, the gentleman in the audience said five years, most of the predictions are 12 months before we have interactive video communications. So as Mario said, it is moving very, very fast and you should take that into consideration.
MS. BOROW: Some of you who know me may think this may be the first time I am almost speechless. Since I agree with what everybody has said in the past, the only thing I would say is that what we really need in the industry and what you appear to be providing is rather than quote "tough regulations" for you to be a participant and for you to really provide the guidance.
And also that we can't just let it stop at the Internet because what is coming in the future, as Lou said, and it's really not in the future, at the end of this year, you're going to see not the first tests but the first roll-outs of true quote "interactive television". There are huge systems of computer-assisted phone services and all of the issues that we're discussing today will play out in those platforms as well.
So I think what the dialogue needs to be is how do we provide guidance for the best sources of interactive communications in the field of healthcare and continue to promote what is happening right now? Which if any of us would have dreamed 30 or 20 or even 10 years ago that probably one of the most hits that occur on the Internet are in the healthcare genre, so what is essentially happening, whether we want to call it this or not, is that there is more voluntary continuing professional education on the part of healthcare professionals and, clearly, patients are taking more responsibility for their own healthcare. In the managed care environment in which we live, that is something we should all be encouraging and you have a great role to play.
MR. PINES: What I hear the panel saying is that they want the FDA to be thoughtful, be fair, be flexible and be quick. And be voluntary. Okay; I think that that summarizes it. Bill?
MR. SCHULTZ: Thank you. I want to thank everyone for keeping their remarks short. We covered a huge amount of material and I want to thank Wayne Pines and the entire panel. I just think it was a terrific presentation and an excellent discussion.
Finally, we will come back and resume at 12:45. If I could ask the second panel to just come up right away and be seated, that will free some seats for the audience.
Thank you. Let's give the panel a hand.
[Whereupon, at 11:45 a.m., the proceedings were adjourned, to be resumed at 12:45 p.m.]