Norvir Advisory
| The following presentations were taped and edited by the International Association of Physicians in AIDS Care. Some of the questions were not included because they were not audible on the taped recording, or were not pertinent to the topics of the update. |
Norvir Community Update - 10/15/98
Abbott Laboratories, Abbott Park, Illinois
Presentation 4
Robert Dintruff
Marketing Manager
Abbott International
Bob Prachar
Senior Product Manager, Norvir
Abbott Laboratories
Tony Japour, MD
Associate Medical Director
Abbott Laboratories
Chris Cruz
Product Manager
Abbott Laboratories
Melissa Brotz
Senior Manager-Public Affairs
Abbott Laboratories
DINTRUFF: Both Eugene Sun and Steve Lichter have provided you with some insight
into what has been going on here at Abbott Park for the past few months in responding to
the appearance of Form II ritonavir. Many of us here have also had innumerable calls from
and meetings with many of the men and women who were on Norvir semisolid capsules.
We have spent time with physicians who have been prescribing Norvir, as well as with AIDS
advocates and NGO representatives, such as you here with us today. These have been
difficult and challenging times for all of us.
One of the lessons that all of us have either learned or had reinforced during these past few
months is that the solutions to our common and individual challenges begin with effective communications. I will begin by reviewing some of the elements that go into an effective
communications plan. Then we will take some more questions as well as your suggestions
and feedback on what we need to do now and in the future to have a more effective
communications plan.
The first element is to define the goal of communications. We had one clear objective when
we started to develop a communications strategy to respond to the Form II problem. Our
objective was to make it clear to everyone in the community that Abbott's primary goal was
to ensure therapeutic continuity for all patients. It would have been very bad news if we
didn't have a liquid formulation to fall back on. Even though the liquid formulation tastes
unpleasant to some people, we would all be facing a more serious problem, some of us a
life-threatening problem, if we didn't have that liquid formulation. So, in one sense, we are
grateful that, even with some of the inconvenience and taste issues associated with Norvir
liquid, this alternate formulation has helped us achieve our initial objective, namely,
therapeutic continuity for all patients. If Form II had been a significant problem with the
oral solution, I'm not sure that we would have been able to meet that objective.
The second element is the timeliness of communications. By timeliness, I mean the time
that it takes to get the communications out as soon as information is available. The next
element is scope. By scope, I mean all of the information that is practical and which the
community of people with HIV disease, their physicians, and other healthcare professionals
need to make treatment decisions. The next element is a comprehensive distribution
network, specifically identifying who needs to receive the information and the ways that
information can be sent to them as efficiently as possible. I think that we have been
reasonably successful in our distribution system and I will discuss this in more detail shortly. Finally, an effective communications plan requires an exchange of information.
Communications is a dialogue, not a monologue. We need to let people know how they
can contact us so that we can respond to their questions in the same way that we are
responding to your questions here today.
Today's meeting is part of our communications plan. We have tried to present information
on a wide range of issues. Some of these issues are very complex, but I think that Eugene
Sun, Steve Lichter, and Steve Byrn have done an excellent job in presenting substantive and
complete information about what happened in the past few months. That sometimes meant
taking highly technical concepts and making them reasonably clear, even providing you with
details that may have seemed relatively unimportant to you, even though these details are very important to us. I believe, and hope that you do also, that we have provided you
with a reasonably complete overview of the problem, what may have caused the problem,
when we knew about the problem, and how we responded to the problem.
Even though this meeting held at this specific site may not have been the best way to
communicate with some of you, you are here today even though some of you encountered
difficulties in traveling to the US. You have provided us with some good suggestions for
future meetings. Possibly we could have invited others to this program. We are always
willing to consider your recommendations of which advocates should be on our primary
contact list. We rely on each of you to bring the information that we have shared with you
today back to your constituents.
With this as a background, I want to review how our communications system responded to
the Form II problem. We began with a press release. We then sent a detailed letter to as
many HIV/AIDS-treating-physicians that we could identify. Different letters were sent to
pharmacists and/or other medication providers and wholesalers. Different letters again were
sent to patients, to consumer hotlines, to AIDS service organizations, to international
NGOs, to Health Ministries in a variety of languages, and to US AIDS drug assistance
programs. We created a dosing conversion guide. We developed a media statement, a series
of question and answer documents, and also included some of this information on our Web
site. We had a teleconference that included both the FDA and US community advocates in
which many of you were involved. We developed special materials for our sales force and
our internal communications staff.
Pharmaceutical companies are subject to a wide range of often complex regulatory
issues. Sometimes we are prevented from stating things that we believe to be true
because such statements, regardless of their intention and accuracy, might be perceived by some as having some marketing edge. So pharmaceutical companies have regulatory
departments that often scrutinize every word and every punctuation mark to prevent any
misperception of official statements and data. Abbott Laboratories has a conservative
but highly respected regulatory department that has to carefully scrutinize and approve
each document and each piece of paper that we want to distribute.
So even though some of you may have felt that we should have responded differently to the
Form II problem, all of the responses and the timing of these responses had to be reviewed
and approved by our regulatory department. Sometimes this review process can take as
much as several weeks to finalize an official Abbott document. While some of us at Abbott,
just like our counterparts at other pharmaceutical companies, wish that we could just send
out whatever information that we believe is appropriate and timely, we do not have the final
say.
Imagine for a minute that, God forbid, you were someone like me working at a
pharmaceutical company, and you had to get a group of people larger than the group in
this room to totally agree on the wording for all of these documents that I just rattled
off. Now let's make that group just as opinionated as some of you in this room. How
quickly do you think you could put this global communication project together and have
it distributed as quickly as possible? That's why I prefaced this analogy by saying "God
forbid."
It is not an easy task. But it was accomplished by our organization in a matter of days. And
every possible effort was made to communicate what had transpired, and what we were
doing about the Form II problem. We were as direct as possible, just as we have been here
with you today. Sometimes we have to answer "I don't know," just as we did today when
we were asked about the timing of the return of capsules on the market. But that's still a
direct answer. We are not going to try to commit or communicate to you something
that we are not certain of.
Just as Eugene Sun pointed out, our currency with the FDA is our credibility. And that
same credibility is our only currency that we have here today. None of us - that includes
me, Bob Prachar, Eugene Sun, Steve Lichter, or any of the other Abbott representatives
here today, are going to stand up and tell you something, or commit to something, that we
cannot do. But when we do commit to something, we will do so with conviction and
certainty. So when you hear a commitment from us, we hope that you will believe and trust
in what we say. Our word is our credibility. Our word is our currency. You can bank on
it. So let's discuss the communications about the Form II problem.
QUESTION: Well, first of all I'd like to say that yes, I heard that there was a problem with
Norvir. I learned there was a supply problem and that it was indefinite how long it would
be. But I went to a number of different pharmacies to try to secure capsules and, as recently
as about two weeks ago, I had pharmacists tell me that there was no supply problem, that
they had lots of capsules and I didn't have to worry anymore. So I didn't even bother
getting extra capsules because I thought the supply problem was over. By the time I find
out that there was still a capsule problem, they ran out. So I would say that the
communications with pharmacies - certainly in Canada - doesn't seem to be adequate.
DINTRUFF: I know that what you encountered was not an isolated issue. You may
imagine what our situation was like from an inventory standpoint when we have numerous
inventory points around the world, which is further complicated by the international
environment. We already described how we finish some capsules in the United Kingdom.
So we have one inventory point for bulk drug. Then there is second inventory point
somewhere else for the capsules. We ship drug over to the UK for packaging which serves the European and South Africa market--additional inventory points.
When you encounter multiple inventory points around the world, you are going to have some varying levels of drug. These varying inventories of drug mean that different countries, and sometimes different regions within a country run out of drug at different times. So we took significant steps to better equalize the various inventory points across the world, and moved some ritonavir around wherever there was a significant imbalance.
PRACHAR: There is another complication. There is an intermediary, a wholesaler,
between Abbott and the retail pharmacy. So while we implemented a proactive strategy to
let the wholesalers know what the problem was and what steps we were taking to correct
it, we also had a proactive plan to allocate remaining capsules to wholesalers based on their
historical purchasing volume, not what they wanted to order and what they said they
needed. That was the only way that we felt justified in allocating the remaining capsules.
Sometimes this policy resulted in communication problems between a wholesaler and a
pharmacy as to what their actual supply at the wholesale level was.
We have tried to work out these specific problems through our national account managers.
These are specific Abbott representatives that are responsible for the big pharmacy chains
in the US such as Walgreens. They also deal with pharmacy chains that are also distributors,
such the McKessons and the Medcos of the world to interface with these other groups. So
this intermediate system adds another tier of complexity when you have another party
holding on to drug supplies.
QUESTION: So you did communicate with all the pharmacists who were dispensing
Norvir?
DINTRUFF: We made every effort to communicate with as many pharmacies as we could
identify that were dispensing Norvir to make them aware of the problem. Did information
get through to every pharmacy? That's hard to say. Based on your question, something
broke down in the communications system between us and your local pharmacy and the
consequences of that breakdown affected you. But we need to know when something goes
wrong so that we can correct it as soon as possible. That is why an effective
communications system needs be a dialogue. We are relying in part on you and other
members of the community to alert us to these situations so that we can respond
immediately.
PRACHAR: The information in the pharmacy letter was about the specific medical
aspects of the product and how to convert to dosing. But so many things were in flux at
that time. Many of the problems that we discovered had to be handled on an individual
basis. With so many thing in flux, it was sometimes trying to deal with a moving target
rather than a specific problem. So if there were miscommunications, delays, or confusion,
it may have been at this stage of the process. The generic letter that we distributed could
only address the general problem rather than the often unique individual problems that
occurred.
QUESTION: I don't want to be overly critical. But there were some Abbott reps
at ICAAC who seemed pretty clueless about the problem. I couldn't get any answers. So
that was a problem. I don't think Abbott has much of a history of fully utilizing the
resource that the community is and in having a constructive dialogue with the community.
If what we are experiencing here today is an example, this is a good step in correcting that.
There was also a problem in how the temperature message was communicated. I think that
goes back to the stability concern that was addressed earlier. But most people were not sure
about the temperature at which you need to keep the liquid formulation. I think there was
a lot of confusion over that, because it was a change, or at least a perceived change. And
from what I've been hearing, it sounds as though the Form II crystal can be in the liquid
formulation as well, although it's more likely to occur in the liquid formulation when it's
kept at a cooler temperature instead of that 68 to 77 degree zone. People who recalled how
to keep the old liquid formulation were, I think, a little bit loathe to leave it sitting out and
were therefore more likely to have a less effective product. And that's something that could
actually have clinical relevance. When people started using the liquid formulation, if
messages like that aren't adequately explained and translated to the patient, that's a serious
problem.
I think one of the best ways of communicating that to the end user is to go through this
community. Just talk to us and to explain it adequately enough to us so that we understand
what the problem is and what the danger is. If that had been done at an earlier date, it
might have prevented some problems.
DINTRUFF: I can't disagree with what you've said. There were good communications with the community early on in this process. Not necessarily with everybody in this room - we couldn't reach everybody. But we did have some extremely valuable input from the very beginning from the community. And I hope, as you've suggested, that this meeting will strengthen that communication.
PRACHAR: I was at the ICAAC booth in September and can explain what may have happened. Pharmaceutical company representatives are held to a higher legal and regulatory standard. Our statements and even our opinions are nearly always considered official company policy. This is why our regulatory department has to approve nearly everything that we can say.
When a physician tells you that he or she doesn't think that something is risky, you generally respect that opinion as one based on science and clinical experience. You don't automatically believe that it is the official position of the AMA or any association of which that physician is a member, or even the position of the majority of the medical community. It's just that physician's opinion. So if you trust and respect your physician, you will generally trust what that physician tells you. Our representatives are not allowed to make those kind of statements based on an informed scientific guess or even on clinical data unless that data has been approved by the FDA. Much of the information that we're releasing today in terms of specificity is information that was an in-progress piece of work at that time.
It's not an ideal situation. So when you walked up to the booth and asked a question, it
could've been a representative from the FDA. And if a representative took any liberty in
saying, 'I think this," or "I believe this," that could be a real problem for us. Someone could
always claim that what we said we believed on a personal level is an official company
policy. This is why on some occasions, our responses may seem vague and we may suggest
that you contact your physician for an opinion.
QUESTION: He prefers to speak in Spanish and I will translate for him. He is saying that
in Columbia, people that are taking the liquid formulation have problems measuring the
amount of liquid that needs to be taken. So it often happens that people take more than
they are supposed to. And when they go back for another bottle, they are told that you are
supposed to still have medication. So they are not supplied with a new bottle and they go,
a few days or a week without medication. So, he is wondering what's going to be done in
order to make sure that people are going to have something to measure exactly what needs
to be taken.
DINTRUFF: The liquid is to be measured in the dosing cup that is supplied. Unfortunately, many people can't really see the lines on it very well. Can we make the lines darker? That's being investigated. We are aware of it and we are looking into it.
PRACHAR: I think most of you are aware of the fact that we do have a Web site with
a question and answer format that addresses a lot of the key questions about ritonavir oral
solution. We are trying to point out again more emphatically that it's critical to not assume
that you just fill it up to the top of the cup. As it is right now to see the lines, patients need
to be aware that those lines are on there. So we're trying to stress that point over and over
again, and hopefully getting that message to a broader audience.
QUESTION: One of the ideas that is circulating both on the Internet and throughout the
community is to take an eye dropper and fill purchased gel caps with the liquid and then
take them. That bypasses the taste issue. The problem is that we know what the absorption
in the oral mucosa is when we take these gel caps that particular way. Is there a difference
in the absorption rate in the stomach or in the intestines, when taking the oral medication
through these gel caps? Most people with HIV do not have the acidity in their stomach that
may be necessary to dissolve the gel caps. Should they be taking, some kind of acidic juice
along with it to help that? We dropped the gel caps in Ensure and it dissolves very slowly.
We dropped them in vinegar and they dissolved immediately. Are you going to be doing
any studies or giving some information so that people can use alternative ways to take the
oral medication?
JAPOUR: We have not directly studied that specifically, but it's something that we have
also thought of. Various AIDS physicians have also thought about it and have had their
patients use these gel caps in cases when they can't tolerate the liquid. Although we don't
have any definitive answer, most physicians will tell you that, since they're gelatin caps, they
will dissolve in the stomach. And as long as the correct amount of liquid is put in, then it
should be fine.
To answer the question from the physician from South America who was asking about
instructing patients - one of the ways you might do it is to have them come into your office
the first time with the bottle of liquid and show them, or have a nurse show them, that this
is the line that you need to go for the dose that you're on, the 400 milligrams versus the 600
milligrams. We can't currently make any changes to the cup, but we are exploring what we
can do to make it more legible so that people know what they're doing.
PRACHAR: At this point, we would like to discuss our taste masking study.
We went to the Arthur D. Little consulting firm which has significant experience in taste
masking strategies for products that, after they were formulated, were not pleasant enough
for patients to take on a consistent basis. We know there are many anecdotes on how to
mask the taste of liquid Norvir. We decided to systematically go through all the categories
of options, and then, with all of the examples possible, identify what we found to be the best
things to help with the taste of Norvir in the interim. What I mean by categories is - do you
prime your mouth with an agent and then take the Norvir? Is that better than chasing it
with an agent after you swallow it? Is that better than mixing it with some other liquid form
and creating a higher volume of liquid that's diluted? Is that better than injecting it with
a syringe and squirting in the back of the throat, to bypass the taste buds? Those were
categories of options that we monitored or that we evaluated.
The consulting firm has a panel of experts - called an expert sensory panel - that tests products and tolerability options for pharmaceutical and consumer products. They are not quite wine connoisseurs, but they do this over and over again. So they started with the flavor profile of Norvir. They analyzed all of the principal elements that make Norvir taste the way that it does. They picked out specific attributes about the Norvir flavor profile. They found the flavor unbalanced and the various flavor elements are not cohesive. They identified a peppermint taste, a caramel taste, a medicine taste, and an alcohol bite. All those things together create an unpleasant tasting product.
So what can we do, based on their expert opinion, to identify a reasonable set of options
that might mask this unpleasant taste, knowing what we know about these types of negative
attributes? That was step one. Step two was testing from 50 to 75 options that, based on
their experience, they thought might work well. They found out that many things that we
thought worked real well, didn't work so well. And some other things that we had a hunch
might work well for various reasons, did work well. What we ended up with was a list of
six products that we tested with HIV-positive patients that were taking Norvir to find out
which of the products helped mask the taste for them. And these are the results.
These are the top performing chasers from #1 to #4: Number 1 is Nutella hazelnut spread
which is somewhat like peanut butter, a little bit thinner in consistency, but with a chocolate
hazelnut spread on top of graham crackers. And just a side note, the consulting firm tried
to test products that are available globally, because we realize that these conclusions would
need to be applicable to a global audience. We also looked for things that would be
portable, meaning that they wouldn't have special storage requirements and might be able
to be carried easily. We also looked for diversity, in terms of if people are taking a dose at
breakfast and evening, we didn't want to just have foods that might be appropriate for the
end of day and no one would ever take for breakfast.
QUESTION: What are graham crackers?
DINTRUFF: It is a cookie, or a biscuit , with the consistency of a cracker. However,
it's sweeter than a cracker.
PRACHAR: And a rationale for it being globally available is that it is a Nabisco brand
name, which is a very global brand, and there are multiple others. That was the top one.
Number 2 was Riessen chocolate chew.
QUESTION: That's globally available?
PRACHAR: Yes
QUESTION: In Canada?
PRACHAR: We can follow up specifically on a country-by-country basis, but we gave
the firm the charter to look at things that are globally available.
QUESTION: I think Riessen's are made by Nestle.
PRACHAR: Riessen's are made by Nestle, so that's reason to believe that they are are
available most places.
QUESTION: What do they look like?
PRACHAR: They are little chocolate squares that have the consistency of a little piece
of fudge. They are individually wrapped. So you can put them in your pocket and carry
them with you. What is important to remember is that this was an expert panel that picked
these products and then tested them with Norvir patients. Taste is a very individualized
thing. This study has statistical reliability in that we surveyed enough patients to believe
that this is a broadly generalizable list. But if you know for certain that other things have
worked with specific patients, do not tell them to discontinue what they are doing. Do
whatever works.
Number 3 is a simple oats and honey granola bar. We have all seen these. There are
several different brands that are individually packaged and very popular. Number 4 was
cracker sandwiches with peanut butter. Just simple tiny cracker sandwiches with peanut
butter in between. There are several brands. They are very popular and you can find them
in most vending machines. These are the top four products in global distribution that the
consultants and patients found most helpful.
DINTRUFF: You will know better than we will what works in a relatively short period
of time to mask the taste of Norvir in people in which the taste is a problem.
QUESTION: Abbott has stated that you are committed and have compassion about what's
taking place with the HIV community and with the patients that are taking the oral solution.
And you made a commitment to also provide these chasers. You must also provide ways
in which this drug is to be stored by the disenfranchised community. You cannot just say
that you're working on these things from the inside. Something needs to be done on the
outside. Because it is on the outside where the community continues to go to their
providers and state that they want to start with or stay on Norvir.
If you want that to continue, you need to demonstrate that you are invested in them and
their future. You can't just talk here. The community must see it. This could further
impact whether patients will want to be involved in future trials. You also must make the
commitment that are willing to lose dollars by transferring your clients onto another drug
and taking the financial responsibility for it. But that will, in the end, make you a more
viable pharmaceutical representative.
DINTRUFF: I agree with that. And let me add to it. When we made the statement that
our primary objectives was to continue therapy for people that were taking Norvir, this
didn't necessarily have to be Norvir liquid. There are other alternatives and we're aware
of that. Some people will make those choices. But that's not our decision. It is a decision in which we cannot be involved for legal and regulatory reasons. Those decisions
can only be made by the patients and their physicians. Those will be tough choices.
QUESTION: Once this problem is taken care of, will the cost of the drug remain the same
or will it change so that you can recoup your costs for all of what's gone into to it this
point?
PRACHAR: No. The cost will remain the same.
QUESTION I think it's really important that you continue to do these studies in
culturally appropriate and socioeconomically appropriate situations around the world, so
people can make use of chasers. I think it's also important to remember that the taste is not
the problem. It's the aftertaste that's the problem. For most people, drinking it and getting
it down is fine. It's the half-an-hour, hour, or longer afterwards where it just repeats itself.
So I don't know if that's been taken into account.
There are many other issues about the liquid formulation that I think we need to talk
about. And given the fact that it's going to be a number of months that people will be
taking it, and there will always be some people who will prefer the liquid in the future as
well, you really need to look at making the pouring and measurement of the liquid
easier. Look at the possibility of having the top of the bottle a dropper that is marked so
people don't have to measure it out at all, they can just shake it, squeeze it, and drop it.
I believe in Europe, people are being provided with syringes when they get it.
I have appreciated today very much. I think it's been a very frank discussion. You've been
very open with information. Since it has been very difficult for many of us with HIV to get
into the United States, you should remember that in the future and hold it in Canada or
somewhere else. Abbott needs to participate in the existing community-based treatment
advocacy and treatment information networks in the world. This crisis has stimulated you
to communicate better. I think the communication since the crisis has been relatively good.
My relationship with the product manager in Canada and other people is good. But
Abbott's participation in community-based networks is not good. I hope that this is like the
dawning of a new era and that you begin to communicate regularly in an ongoing way with
these networks, which are not perfect - none of us would say they are - but they are
representative of and an important link to people living with HIV around the world.
DINTRUFF: You're right. The issue of how we deal with the community has been a very
important one. And I only speak for the international part of that, but I agree with you that
it has not been the best. Although over the last year or two, we have had a number of
interactions with the community and involved a lot of people from our organization in those
interactions. And no one has ever come away from one of those discussions and said this
was a waste of time. They are always extremely productive and very helpful, without
exception. And that's been my experience. These interactions have been excellent.
PRACHAR: You mentioned community involvement. This meeting is not an isolated
gesture by Abbott. It is the first in a series of programs that we hope to roll out during the
next few months. Although this pilot project is a US-directed initiative, if it is successful,
we will consider extending it to other countries.
We are planning a series of community ASO town forums. And I know a lot of the people
in this room from the US were invited to work with us on this project. We have thirteen
town forums scheduled to date, and they will be geographically dispersed. There's really
only one person that knows 99.9 percent of all the specifics of the contents of these
meetings, and that's Eugene Sun who spoke to you earlier today. Eugene is going to be the lead person along with some others from our scientific venture and our R&D team that are going to implement this project. These forums will basically be an abbreviated summary
of what we have presented today with less of the more technical scientific information to
make the presentations more practical to a general audience. Dr. Sun and the other
members of our scientific team will essentially be beamed by audio from Abbott Park, and
then representatives from Abbott will be at the local sites. Dr. Sun will be able to flip
through a presentation in his laptop computer which will be projected on the screen. He
will be controlling the pace of the slides and explaining the gist of the situation. Then there
will be a period of time that patients and advocates can ask questions and have dialogue
directly with Dr. Sun.
We will also work with various ASOs to secure participation of a local physician in the
community that has had experience converting patients from capsules to liquid. If a patient
feels comfortable getting up and sharing their own experiences and things that have worked
for him or her, he or she will have that opportunity. We are asking for your advice on what
we could do between now and the end of the year, that might help and get the message
down to a grassroots level with your constituency. This is just one more communications
project that we are developing. So tell us what you think. Give us some
feedback.
QUESTION: Just a couple of comments. One, as somebody with a media background,
I think that overall, you've certainly taken some extraordinary means to try to communicate
with people and, obviously, no one route is perfect. The community meetings, I think are
good. There's obviously the question of who you're trying to communicate to. Is it more
efficient at those meetings to communicate with advocates and case managers versus trying
to communicate with patients, since there's only going to be so much access for patients
to get to that meeting. One question. What other methods are you also going to utilize that
may be compatible with that town meeting? Another question I have for everyone that's
here today, after we've gone back home and kind of regurgitated this information and had
some thoughts about something that may be helpful to patients, or a better way of
communicating to a specific population, what would the follow-up mechanism be from
today's meeting?
PRACHAR: You asked two questions. One was who is our target audience for the
forums. We have left that decision to the local ASO that we are working with to coordinate
these forums. So each forum will be tailored to the specific needs of each community. We
respect each participating ASO's experience in the unique dynamics affecting the population
that they serve. So we left it to their discretion to involve only patients or involve case
workers, etcetera. Each forum will be a partnership between Abbott and the ASO.
The other question that you asked was about the feedback mechanism after each of you returns back to your community. How do we do that? Melissa, is there a possibility that we have ongoing communications or one centralized vehicle that comments can funnel back into?
BROTZ: For the US, you can contact me or Kim Modory. Rob will have to coordinate the feedback from everywhere else.
DINTRUFF: The situation internationally ends up being somewhat different. There are
certain regulatory constraints that they have in the US that we don't necessarily have in
international markets. What that means is that we can communicate things differently.
Maybe it's a card to patients or something that describes some of the issues or talks more
directly about taste masking approaches, because they don't have the same regulatory
constraints. So it's one that's really impossible to answer right now.
QUESTION: I will translate again. His salary in Columbia is $180. It cost him half a
month's salary to pay for the taxis to come in. The crackers and all of the taste masking
products are not available in Columbia. Even if they were, most people couldn't afford them. There is a high degree of malnutrition. People cannot take certain antiviral drugs
because they are not on the list of official medicines. To make a patient comply with a
treatment is very difficult.
We need to have information available in Spanish. We receive information through a
Spanish NGO and through the Internet, but almost nobody has Internet in Columbia. All
that is available is information in English which most patients can't read. Communications
must be in the language that the patient speaks and reads.
DINTRUFF: There are considerable language obstacles when we begin to look at this
problem from a global perspective. And one of the things that is in some ways difficult for
people to understand, particularly for people who have grown up in Western Europe or
spent their entire life in the US can be summed up in one statistic - half of the world has
never made a phone call. When you think about that, that's a pretty amazing statistic. But
I believe it's true.
I can describe much worse situations than what we have in Colombia. I've been to Colombia
recently, and I understand the situation which is extremely difficult. And we need to do
things that are under our control to be of help there. And one of them that you touched on
at the very end is get more things translated and work with the appropriate people to do that.
And I think that is probably one area where we can help.
Can we provide any of these other things that are not generally available? In some cases we
may be able to, in other cases, it's just going to be logistically impossible. I don't have an
easy answer for that question.
SUN: We now need to conclude this part of the meeting and you will all have an
opportunity later to ask more questions at our dinner this evening. You can rest assured
that when we have significant developments, either good or bad, you will know very
quickly. When nothing is of significance or we're not making major progress or not having
major missteps, we do not feel that there is as urgent a need to communicate, although we
would still like to maintain lines of communication.
This forum has been very helpful in terms of ideas and issues, and listening to your questions
about how we are going forward. You are free to contact us any time that you have a
question. All the folks in public affairs, both PPD and Abbott International, are also available to answer
questions of a technical nature, whatever they may be. If we say that we don't know when
you ask a question, it will be because we don't know and not because are holding anything
back from you.
Our philosophy going into this meeting was to tell all, even if it was in technical detail,
with the hope that you can better understand what we have been through, and that we
are extremely sincere in our effort to return to a capsule form of Norvir. But in the
meantime, we want to assure you that we're doing everything that we think is doable
and reasonable to make the liquid a product that people can live with. So, thank you for
you input, and I hope that this forum has proved as helpful to each of you as it has to
me.
Posted 12/28/98
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