HIV/AIDS Activists Give Harsh Grades to Drug Companies

An Interview With Bob Huff

On Sept. 10 the AIDS Treatment Activists Coalition, known as ATAC, issued report cards to pharmaceutical companies that make HIV/AIDS medicines. The grades ranged from Bs to Fs and were pretty harsh. To find out more about this, I spoke with Bob Huff, who is a well-known HIV/AIDS writer and activist as well as a member of ATAC's board of directors.

ATAC Report Card

The Report Card: Summary and Results

Welcome Bob! Well, it was all over the New York Times! ATAC issued report cards to pharma and the average final grade was a C-. Can you talk a little bit about these report cards?

Bob Huff

Bob Huff

Yes, ATAC issued a report card on the performance of the pharmaceutical industry -- specifically the companies involved in marketing and developing HIV drugs, antiretrovirals. We graded them on the basis of their drug development process; on the innovation they've shown in developing new drugs; on their access programs both prior to approval and after approval; on pricing; and on their commitment to fair and balanced advertising and marketing practices.

Finally, maybe most importantly, we graded them on their commitment to involving the HIV community in the research and drug development process from the earliest stages, so that the drugs that finally end up on the pharmacy shelves and the information that's produced from the research is really useful to the people who are going to use them.

We decided to do this because we've provided them with all these messages, such as:

  • Pricing has to be sustainable.
  • Raise the bar on the quality of the drugs, so that people can live with them for 30 or 40 years without side effects, without diarrhea, without sleep deprivation.

We say this all the time when we meet with them and we have for years, but we're frustrated because some of them don't take it seriously and some of them haven't improved their performance. So we decided to issue a report card and put it out there publicly so next year we can come back and see who's really stepped up the game.

Report Card Background

Let's first talk about the bad boys. I see Abbott Laboratories didn't do very well.

Yes. They're back of the class. It's basically because of Abbott's infamous 400 percent increase of the price of Norvir [ritonavir] that they took back in 2003. This is such a famous blunder that it's taught as a cautionary tale -- as a case study in business schools. It's very well known. But Abbott also hasn't really embraced the principles of community engagement in the research process by involving members from the HIV community in the safety advisory boards or in the mechanisms by which the drugs are developed.

Abbott has also said that they think Kaletra [lopinavir/ritonavir] is pretty good and they haven't found anything better, so they're not that engaged in looking for new HIV drugs. They've kind of changed their focus to hepatitis.

A few things went into this grading, but I would say predominately it's that 400 percent increase in the price of Norvir that's responsible for their grade.

There are still many people taking Kaletra and Kaletra still has a good name out there. I don't know if its market share has changed very much as a result of all the protest.

I think it's slipping, declining slightly.

But not because of their bad behavior. It's declining because there are other good drugs, right?

There are other better drugs coming along. Their bad behavior was essentially to protect that market share. It's a complicated story, but it wasn't handled right. It was an egregious violation of trust with the community. It was really designed to thwart the competition. Because other drugs depend upon Norvir for boosting. Other protease inhibitors do. And Norvir is included in Kaletra.

So they could afford to make it expensive.

They could afford to make Norvir expensive and Kaletra remains the lowest priced of the protease inhibitors. They get marks for holding the line on the price of Kaletra, but the point of doing it was that they wanted to make the competition much more expensive so that it would drive the market share towards Kaletra, or at least stop the erosion of the market share. I think that was the claim that was made in a lawsuit.

So they're acting like a regular business with shareholders, etc., and not a drug manufacturer that's manufacturing a drug that's saving people's lives.

They're doing all of the above. What they need to do is take the community more seriously, engage with the community, and listen to them and play fair.

They've never made amends to the activist community?

They have not rolled back the price.

Have they tried to establish a dialogue?

They have. They're not extraordinarily successful in that department.

Why's that?

I don't know. You have to ask them.

They are at the bottom of the class. Who do you have right next to them?

I think the next one is Hoffmann-La Roche Inc. Roche has in the past marketed, didn't really develop, but helped develop, Fuzeon [enfuvirtide, T-20], which is the most expensive HIV drug out there.

How much is it, do you know?

When it was launched, I think the official price, which is not really what people pay, but the official price was something like $25,000 dollars a year, which is quite a bit more than the next one below it.

Is that price based on any ingredients in the drug?

The rationale was that it was a complicated injectable drug. It was complicated to make, distribute and administer, and required a lot of support. But they're backing out. They have said that they have discontinued actively looking for any new HIV drugs. They're focusing on hepatitis.

That's another thing that really prompted this report card. This is a time when we're seeing a lot of change in this industry. We're seeing Roche stepping away. Merck & Co. has purchased Schering-Plough Corporation. Schering had an HIV drug in development, but none in the market. We now see GlaxoSmithKline [GSK] forming a joint venture with Pfizer Inc. to create a separate standalone HIV-focused company. There's a consolidation there with Pfizer backing away.

Is that good or bad?

Let's say it could be bad if it means that they're just putting HIV-drug development out to pasture, saying, "This is a mature industry. We're not going to invest in it much anymore." That would be bad.

I prefer to see it as an opportunity to bring the best and the brightest from both companies together and synergize with their portfolios and really do some creative thinking that wouldn't be possible in the big mega-structure of a corporate giant like GSK or Pfizer. Hopefully it will take us to the next level in which new therapies are very tolerable and safe and effective -- the kind of things that people can use for a long, long time. That would be great and that's what we're trying to leverage here with the report cards. That's what we want to see happen.

But don't you think this could backfire? Nobody got an A.

There's room for improvement. I think that's what the membership said.

How many members do you have, by the way?

This is the membership speaking. I don't know what the membership is. I think about 21 people were involved in this grading process.

Some people were tasked with collecting the information. We set up a set of questions to ask that we wanted to know about. We thought this is the important stuff to know about. We collected the information, organized it, made the language very neutral and then presented it to the membership to assign grades and vote on it.

We collected all that and averaged the grades. What you see is a reflection of the collective wisdom of the membership, which is a group of very diverse community members, including some very long-time AIDS activists, from all over the country. This is the collective take on it.

I think they got it right, from my perspective. I think it's a very tough set of grades. No one got an A. But I think they got it right if you look at the strengths and weaknesses of the individual companies.

What I really want to see is someone get an A next year when we do this again because that means they're taking these lessons seriously. They're stepping up the game and performing better. If they do perform better, I think the membership of ATAC will recognize it and reward someone.

Is this the first time you guys have issued grades?

This is the first time we've done it in this formal way. I think there was an earlier attempt to do this in the past. But I don't know what the grades were. This is our first outing and this really looks back over a long period of time. Subsequently, this is the baseline. We're looking for improvement.

It seems odd that you're being so tough on the drug companies now when they've just finished developing drugs that have transformed HIV care. No prizes were given back then to Gilead Sciences Inc. and Bristol-Myers Squibb Company [BMS] for their collaboration that created a one pill, once-a-day med; to Tibotec Therapeutics for their many drugs that they quickly got approved; or to Merck for their new drug. It's a very funny moment because it's after this amazing time and suddenly there's very little that's new in the pipeline. So is the ultimate goal here to spur some movement to get the pipeline rich again?

I think so. We looked at the pipeline and saw that there wasn't any dramatic big plateau on the horizon that we were going to jump up to. That's concerning because as good as everything is right now, it's not perfect. I would say though that Gilead and BMS have been well rewarded. [Laughs.]

Oh, you mean monetarily. [Laughs.]

[Laughs.] Yes. They have a very successful drug. Isentress [raltegravir] from Merck is starting to do very well and getting better all the time. So, they've gotten their rewards. I think you're absolutely right that there's a gap in the pipeline. At the Cape Town conference, we saw some new stuff announced, which was after our voting. It did give us some optimism for some possibilities.

Like I said, the Pfizer-GSK joint venture has the potential to do some really great stuff. So this is a good time to, as you say, spur them on to better performance.

Let's talk about some of the companies that did well, why they did well, and how they managed to work well with activists and keep activists in the loop with respect to all the things that they do. And tell me about how ATAC deals with these companies.

Let me start with I think that the highest grade was a B overall. Tibotec, for example, got its high marks because they have really embraced the principles of community member engagement at all levels and all stages of the drug development process. That's kind of built into their thinking now. I think they recognize the value of it.

They have community members who attend these inner sanctums that were never seen by the public, such as investigator's meetings when they're launching a clinical trial. Members have sat on safety monitoring boards for clinical trials for new drugs that look at the same information that doctors do and monitor that.

The watchdog role of community is built in, but also the consultation role and the advice are built in. I think most people on the industry side who've been doing this a long time, if you talk to them, they recognize the value.

Tell me what the value is.

The activists in ATAC find out what's going on with every company. They meet with all of them. Companies can't really do that so we're like little bees carrying pollen and information and ideas from one flower to the next and stimulating ideas. We'll come in, we'll look at a protocol in the early stages of design and say, "Well, you know, you're putting people at risk with this protocol because look, the people who are going to get the placebo are only going to have one active drug. That means that they have a chance at becoming resistant. That's not acceptable anymore."

We've had people kind of scratch their heads, "Oh, we didn't think of that." Then, they have to go back to the drawing board and find something that's really going to be an acceptable and ethical way of doing the research.

Even though they are being advised by physicians and other people, they wouldn't necessarily come up with the same perspective?

Well, there's a lot of inertia.

In the old days, the activists went into the streets. They handcuffed themselves in various company offices to get attention and make change. And it worked. It changed the FDA [U.S. Food and Drug Administration]. It changed how the NIH [U.S. National Institutes of Health] works. It changed how the AIDS Clinical Trials Group works when those barriers were knocked down. There's a deep historical and unique relationship between the community and the HIV research structure.

When you say unique, is this not true about other disease states?

There's been some in breast cancer. Some great activists have done some stuff. Hepatitis is now starting to have one. It's happening with tuberculosis now. Basically, it's because the HIV activists have moved over into those fields and are bringing those lessons. There's a lot of resistance, frankly. Doctors often don't want the patients meddling in their business. The HIV doctors learned that, "Wow, it's not a threatening thing. It's a good thing."

But it took 25 years to get to this point.

Definitely, I'm sure cancer could learn from it.

We're still really at the little baby-steps stage for other disease states in terms of getting the kind of activism that's almost the norm now in HIV.

What ATAC does is a great model.

It'd be a great model, yes.

Background on AIDS Treatment Activists Coalition

Tell me a little bit about ATAC. How old is ATAC?

ATAC was formed, I think, back in 2001.

It was intended as a body that would serve as a coalition between all these individual activists. We had TAG [Treatment Action Group] on the East Coast in New York and Project Inform in San Francisco. Then there were activists working out of GMHC [Gay Men's Health Crisis] and APLA [AIDS Project Los Angeles] and down in Houston and in Chicago.

There were people writing about treatment or working for AIDS service organizations or activist organizations or information providers. It was really a mixed bag but they all had this thing in common. They've been involved in treatment activism and negotiating with the pharmaceutical companies. They wanted some kind of structure that was going to bring on new, younger people, and mentor them, and create opportunities, and also act as an umbrella structure so that the companies couldn't co-opt the activists, couldn't co-opt their consulting community members and so that there was some distance there. That was the intention then. And that's essentially what ATAC's done.

Can anyone become a member?

We encourage people who are interested in ATAC to find out more about it, find out more about the history of drug development and the terms, and maybe talk to someone who's in ATAC.

We're looking for new members. It's kind of a steep learning curve, I would say, because there's a lot of terminology and concepts to learn about the drug development process, and statistics and medical jargon. But a lot of people who have no background in this at all, but have a keen interest in having their voice heard in this arena, take right to it and do great. There's, I think, a process of growing into it. But we encourage people who are interested to look at the ATAC Web site.

Can you talk a little about what's required for membership? How often do you have meetings?

A typical meeting would be maybe an internal meeting, an educational meeting, a meeting with a local researcher whatever city we're in, and then preparation for meeting with the drug company, the meeting with the drug company and then a debriefing from that. And maybe two drug companies would be met with.

We do our homework. We meet. We put our issues out. We hear what they have to say, deliver our messages and do some analysis of what we've learned. That's a good long day's work. A typical meeting would be three days and maybe we'll have four of those a year.

The Europeans have a similar group called ECAB, European Community Advisory Board. That operates on a similar schedule, different style slightly. We have a very open communication with those members as well.

Since it's the same drugs being developed by the same companies, are their experiences different from yours?

We have different takes on some things, but it's basically the same. I think -- and this is a nice thing -- because it's a coalition, you get a lot of independent minds thinking independently, and then we come together and we compare what we think. That's a good test of the validity of ideas. We're really subjected to kind of a consensus process. The good ideas you shake out and the bad ones don't get far.

And that's built into the structure.

It sounds as if ATAC is really perfect for people who are HIV treatment geeks.

Yes. I have to say that's me.

[Laughs.] If you like to read journal articles --

Journal articles, abstracts, the conferences.

Don't you think that it's going to be pretty necessary to become more of an activist in the coming years because there is such a dry pipeline? I think people don't really understand the history. People have to learn the history of HIV so that they can understand that the best time just passed.

There's so much interest now in hepatitis, and rightfully so, but what happens in the industry is that there's a horse race to see who gets there first. It's not completely rational, but it happened with HIV. There's something about being the first. And then you worry about who is best later on. But being first gives some kind of bragging rights, so there's a huge race to be first to the market with a hepatitis C drug right now.

That's drawn some attention away from HIV, for which people think the treatments are pretty good. Doctors are happy. Most of their patients have undetectable viral loads. But some people still have problems with their regimens. If it's GI [gastrointestinal] problems or poor sleeping, that doesn't make for an ideal quality of life for the next 30 or 40 years. Or if you forget, can you forget for a few days? Or get sick or run out or not afford them? There are still some barriers to perfect adherence, perfect tolerability and perfect suppression.

I think that's the big worry, that there are huge barriers -- particularly in a lot of people who get infected in their 20s. They're still organizing their life. They're still living a somewhat chaotic life. They're trying to get everything together. They're dealing with a life-threatening illness. It's hard. It's challenging to do it all. You could screw up a little bit on your meds and then you have to do second line and then third. And you still have to get out of your 20s! [Laughs.]

And that second line isn't as easy and fun as the first one.

But don't you think that HIV treatment is a real challenge for people who are getting their lives together and trying to get jobs and love lives and all this other stuff? There's going to be a bunch of screw-ups. We have to understand that. The whole idea of sequencing seems to not be talked about anymore. And yet it's critical, because now more than ever there are not a lot of options if you become multidrug resistant.

If there are better drugs though, maybe sequencing can go away because you don't have to deal with it. I'd like to imagine that the next generation of drugs will be much more reliable. Companies have to keep their eye on the ball, if we're going to get there.

Will Drug Companies Cover Copays?

Let's discuss some other things that appear on this report card. You mentioned that the community would like a lot of these drug companies to cover 100 percent of copays. What does that mean?

The copayments are imposed by insurance companies. The copay prices have been going up and up. For people who take multiple drugs, and thus have multiple copays, they could be paying half their rent in copays every month.

They may be paying 400 dollars a month in copays?


The insurance companies do this to keep costs down, frankly. It's called a barrier to utilization. If you put up these barriers, the fact is fewer people will use their insurance and you don't have to pay out as much. The drug companies have almost universally set up some kind of program to reimburse or help with the copay payments to keep the costs manageable. That's a new thing. It's kind of a patched-over plan. It's a patchwork of different plans.

What's it called? The patient assistance programs?

There's a patient assistance program. It covers the costs of the drugs for people who don't have insurance or maybe don't qualify for their state ADAP (AIDS Drug Assistance Programs). There is that in place for emergencies. But this is separate. These are separate programs, which are similar, but they're just intended to cover copays.

They're calling these temporary programs at the time. We want them to become permanent. We don't see this problem going away. We'd like to see health care reform that makes all these problems obsolete, but this is the messed-up system we have. The idea is if people can't afford these copays, they're not going to fill their prescriptions and that's bad, bad news. We'd like for them to be more consistent and easier to understand, and we'd like to see a little more commitment to them going forward as long as they're needed.

Are these drug companies interested in making this change?

It's still pretty new, so they're working them out. I think there are a lot of ideas being tried out right now. Other people cover this much more closely than I do. I tend to focus on science more than the access issues, so I can't give you all the details of which programs are really working out, which ones are causing problems.

If people are interested in getting one of these companies to help with their copay, they could go on the site?

Yes. That's important. Some of these companies have programs, but no one's heard about them because they don't really promote them. But yes, generally, you should be able to go to the company's site for the drug and hopefully, prominently, it should be displayed there somewhere that there's this program.

Alternatively, you can get a card from your doctor, if your doctor's a big HIV provider, or from your pharmacy, if your pharmacy has a large HIV clientele. These cards are out there. They explain how to do it, or you can get one right off the Internet. Or you can call the patient assistance program for a company and then they should be able to give you the information on their copay system. [Click here for numbers to call for HIV/AIDS patient assistance programs.]

More Report Card Results: Grades in Tricky Marketing

On to marketing. I'm looking at the Most of the companies got fair to middling grades on marketing. Tell me what was wrong with the way they market HIV meds.

One of the lowest grades was that of GSK. GSK has had a pattern for many years of bashing the competition -- raising fears about the competition's side effects. It's because they were in a situation where their market share was eroding and another's was gaining [i.e., as people switched from Combivir (AZT/3TC) to Truvada (tenofovir/FTC)]. That's a strategy that they used to hold that back.

The problem we have with it was it's based upon fear. It's not an ethical way, we feel, to address the community.

But Abbott, of course, got an F. [Laughs.] It got a lower grade than GSK.

Yes. Well, Abbott did a lot of spin, again, around the 400 percent price increase.

They actually put out some materials that the FDA sent them a warning letter over because it was misleading. It was comparing apples to oranges. Norvir was approved as a protease inhibitor, but it's not used for that now. It's used as a boosting agent. It's a little slippery thing going on between what it's indicated for and what it's used for. In responding to the furor around the price increase, they put out some materials that were misleading and the FDA cited them for that.

I think a lot of people don't realize that in the marketing of some of these drugs, the companies don't just say, "My drug is great." Could you talk a little bit about that?

The classic one is GSK doing educational presentations on the kidneys. Why is GSK being so generous with informing the community about the health of their kidneys? Of course, everybody should know about the health of their kidneys. It's very useful information. It's good information. It's true. But it's actually aimed at the idea that their competitor Gilead's product tenofovir [Viread] has kidney toxicity. They were raising kidney issues to point out concerns about kidney toxicity using the competing drug.

Tenofovir is Viread and Viread is in Atripla [efavirenz/tenofovir/FTC]. And it's in Truvada. So they get to hurt any number of drugs.

Right. That's an example of that.

If there's a workshop at an AIDS organization and it's suddenly about the horror of heart disease in HIV --

That might be coming from someone who wants to bash GSK's abacavir [Ziagen]. There were a couple of reports from a large cohort that associated abacavir with some cardiac events.

There might be some company who has a nice workshop on how horrible depression is in HIV, and that we should be very aware of it.

That would be aimed at efavirenz [Sustiva, Stocrin].

Efavirenz is Sustiva and it's in Atripla. What company would be doing that one?

If you saw something like that, it might be coming from someone who has an alternative first-line treatment like Kaletra, so it might be coming from Abbott. It's a game they play among themselves. Some do it more heavy-handedly than others. The ads that GSK was running were basically saying, "There are sharks out there." They show these shark fins in the water. That was aimed at "Don't rush to change your regimen."

You could make the argument that was aimed at people who were taking Combivir, keeping them from switching to, say, Truvada. It was done during the time that the shift to Truvada was well underway. This was only about a year and a half ago, so it was just a message to say -- which is a fine message -- don't switch meds without talking to your doctor. You have to talk to your doctor if you want to switch anyway. But it was really designed to raise fear about switching. Again, that crossed the line.

Taking the other side: What's a company to do? They're just trying to do their jobs. They're just business people. They have a product. They're trying to get attention for it. And they're trying to maintain market share, etc. What's bad about that?

You can do that, but you're going to get a bad grade from ATAC. People are going to point at you and say, "You're hurting people." I think they'll have to think twice about it. There may be voices inside the company saying, "Wait, this is not ethical. This is not a road we want to go down." And maybe they'll have a bigger voice the next time this discussion comes up. That's the influence we're trying to have.

Are you going to have a meeting with all these companies and give them their report card?

They've seen the report cards. I'm sure it'll come up when we finally do meet with them in turn throughout the upcoming year.

So they didn't get upset with some of the grades that you gave them?

I don't know the details of all that. I haven't heard all the responses. I'm sure everybody wanted an A.

Everyone got fair to middling grades. Yet many drug companies feel that they go out of their way and try so hard to work with the HIV/AIDS community and meet with activists. Do you think people working at the drug companies might see this as being ungrateful and get mad at the activists?

Some individuals might. But this is really aimed at the collective impact of the company. Some companies are being very well rewarded. Some are not. Some are having a hard time. But it's really not about individuals.

What's the next step here? You've given out the grades. You've announced it. What happens next?

We're going to open a dialogue. I'm sure we'll get into conversations with the companies about the specifics. We'll try to promote some ideas of how they can do better.

We have 10 guideline steps for improving their performance. [Click here to view the 10 steps.] Those range from developing new treatments to consulting the community and honoring commitments to keep up with post-approval research because it's not just the drug that they're bringing to market, they have to produce the information about the drug and how to use the drug. It's a complicated scene out there. You have to work out all the interactions and certain populations have special needs and there's a lot that has to be understood so the drugs can be used safely.

We're interested in people who have absolutely no options. There are people like this who have resistance to everything -- even to all the new drugs that are out there right now. Possibly, because they were in the clinical trials for some of these drugs and they got the placebo and they only had one active drug, so they became resistant to it. We want new mechanisms to give them very early access to experimental treatments. The FDA's heard that and they support that.

Is this called compassionate use?

It used to be called something like compassionate use, but it's all expanded access or early access. What we're doing is looking now at a very early, early access.

How early?

It could be before phase 3. It could be late phase 2. It's usually when you've got a really good idea of the dose and it's a very limited number of people.

But the FDA seems to support it. The companies have to support it. But as you said, the pipeline is not rich right now.

And the states programs are strapped. If the hundreds of thousands of HIV-positive people who still haven't been diagnosed were to enter treatment, that could break the bank. Something has to budge on pricing.

In closing, it's great to hear that there are people who are sitting in on meetings at drug companies and helping with this process and advocating on behalf of the one million or so people in the United States who have HIV and the 200,000 or so who are on treatment. But what if somebody who doesn't know that much about treatment wants to join or help you guys in some way? Do you need donations?

We absolutely need donations. In the New York Times article, it's very clear that funding is one of our vulnerabilities, so to speak. ATAC is mainly funded by the pharmaceutical companies that we're criticizing. One of our goals as an organization is to really diversify our funding.

Individual support would be a big help in that. It helps with our independence. I've got to say that the membership is probably largely unaware and wouldn't care anyway [laughs] about where the funding is coming from. They're bulldogs about these issues. You can see from the grading, they're really tough.

It was a tough set of grades that came down. I think they're reflective of the reality and the perception of this very diverse membership, but yes, definitely on the tough side. So the positive spin is that this is where we want to see improvement.

Do you expect next Sept. 10, 2010, you'll have new grades?

Yes, I think so, and especially if we see improvement. I think we want to really call attention to that and bring that out. If nothing changes, or if things get worse, that'll be a problem.

Thank you so much, Bob. I really appreciate you taking the time to talk with me.

This transcript has been lightly edited for clarity.

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