NT-3235

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Dummy of a supposed dead body attached to a kite like sign reading: "silence death" flying in the air against backdrop of a high rise building

Funding for the show announced and overlays the Eleventh Hour graphic still

Host Robert Lipsyte welcomes viewers and announces the show. He holds up a bottle of the expensive medicine used to fight AIDS, AZT. He states that although its the only approved drug used to fight AIDS, it only works in half the cases - he announces possibility of other drugs that haven't passed through many years of lab testing and bureaurocracy.

Cut back to The Eleventh Hour studio, Host Lipsyte introduces his first guest.

Insert Interview:

Robert Lipsyte:
Derek Hodel is angry too and he's doing something about it. He's the executive director of the PWA Health Group which imports foreign drugs that haven't been approved in the United States. Derek, welcome, as I understand that PWA is a nonprofit cooperative, kind of an underground buyers market for drugs. How do you know about drugs that are proven effective in foreign countries?

Derek Hodel:
What we've found is that people with AIDS in the last few years have developed information networks have done a tremendous amount of research into the drugs that are being worked on are being proved useful in terms of fighting AIDS. These people and their physicians are up on medical literature, are aware of drugs as they become approved in other countries, it's not difficult. Although the the the process is typically one that ordinary patients haven't become familiar with.

Robert Lipsyte:
Now we're talking about drugs that are passed through rigorous standards in other countries.

Derek Hodel (NT-3235) 05:08
Absolutely.

Robert Lipsyte:
So how come? Your cooperative members know about it, and the FDA doesn't seem to either know about it or to approve it?

Derek Hodel:
Well, the FDA has a very complicated drug approval process and the longest one in the world. A drug that we import has been approved for use is safe and effective in any of a number of other countries, often in Western Europe, Japan, Mexico, the FDA will undergo an approval process for a drug in this country that it's extremely complex, and will not necessarily look at data from foreign countries, they'll oftentimes start right from scratch in order to approve the drug. The process can take years and years for an ordinary drug, eight to ten years. Even for AIDS drugs, the process is still extremely long.

Robert Lipsyte :
Is what you're doing perfectly legal?

Derek Hodel:
Absolutely. The FDA has had a policy for some time that permits people with life threatening illnesses to import medications that are not yet approved in this country for their personal use. What the buyers clubs have done is to help people make the contacts necessary in order to import personal use drugs. Typically, a person has a hard time communicating with the Japanese pharmaceutical, for instance, and so we try and take care of that for them. But the importation is still done on an on a personal level on an individual basis.

Robert Lipsyte:
I see. And before this people were going over individually, I guess. and buying drugs with a permit?

Derek Hodel:
Those who could afford it, yes. People with AIDS, who had the means to, would often fly to Europe, fly to Japan in order to see doctors to acquire a medication that they knew was there and could be used for

Robert Lipsyte :
Are you in contact with the FDA? I mean, are you giving information back to them?

Derek Hodel:
I mean, as we don't ordinarily give information back, although the FDA is certainly aware of what we're doing, we've met with them periodically. And they check up on us to make sure that what we're doing is aboveboard,

Robert Lipsyte :
But let's look at some of the drugs that you're dealing with.

Derek Hodel:
Perhaps the most interesting drugs at the moment are this drug here. This is called fluconazole. And this drug called Itraconazole, both of these are used to treat infections that people with AIDS get, precisely their fungal infections. For instance, oral thrush, or fungal infections like histoplasmosis, coccidiodomycosis, or most importantly, cryptococcal meningitis. In this country, the treatment for cryptococcal meningitis is called amphotericin b, Nurses and practitioners will often refer to amphotericin is amphaterrible, and patients sometimes call it shake and bake because it has tremendous awful side effects. It causes spiking fevers, shaking chills, which can't be stopped, and occasionally, more serious side effects like renal failure. The amphotericin, which is here, is a drug that has to be administered intravenously, oftentimes for the rest of one's life on a maintenance basis, and which is, which requires a Hickman catheter, this is a catheter that comes out of the chest wall and is permanently implanted. The fluconazole, which is approved in eight countries in Europe, is taken orally and it's almost free of side effects. This drug has been approved for a year in those countries, is in phase three clinical trials here and so is very near to approval in this country as well. And everyone agrees that it's going to be approved. It's just a question of when.

Robert Lipsyte:
Now it's they're equally effective if the foreign drug is not more. So what about cost?

Derek Hodel:
The cost oftentimes is prohibitive. The fluconazole is extremely expensive. Yeah, where it's sold. This one capsule retails for $16 in England, and a person often takes one of those every single day. So it's an extremely expensive option for some people. A drug like this, however, these capsules cost about $1 apiece, and so that's a little bit more reasonable. It varies depending on the drug. But the things that we import, are available only to those who can afford it. That's something that we haven't been able to do anything about because all we're doing is helping people to purchase them.

Robert Lipsyte :
Well buying in bulk, you don't reduce the price.

Derek Hodel:
We can sometimes make a lower price available than would ordinarily than they'd ordinarily get by going to a pharmacy.

INTERVIEW INSERT CONTINUED:
Robert Lipsyte:
Well let me ask you does, you know conventional medical insurance covered drugs imported from overseas that have not yet been approves
Derek Hodel:
Generally no. Third party reimburses in this country generally approve only drugs that have been approved for use in this country and they don't want to know from other drugs. Yeah.
Robert Lipsyte:
So this is still these these so called "alternate therapies" and are still only for people who can afford it.
Derek Hodel:
That's absolutely correct. With one exception, this drug here we imported from England. This is called pentamidine and is a drug that's extremely useful for preventing pneumonia in people with AIDS. The drug has been approved for use in this country now for some months, and his mac is manufactured here it looks like this, where this file though retails for 150 to $200 in the pharmacy This one retails for $25 in England.
Robert Lipsyte:
What would you like to see happen?
Derek Hodel:
I think we'd like to see a system that accounts for data from other countries for patients needs while a drug is being approved. During the process of clinical trials, sometimes drugs can be useful, particularly when there's no other option. We'd like to see a system that takes those needs into account. We'd like to see drugs more readily available once there is enough evidence to suggest that they're useful.
Robert Lipsyte:
That would put you out of business.

Derek Hodel:
It would put us right out of business and we'd be happy to go.
Robert Lipsyte:
Derek Hodel, thanks very much for being with us.

Interview with Derek Hotel ends. Host Lipsyte, the Eleventh Hour graphics in bkgd. announces his next guests.
INSERT INTERVIEW:
Robert Lipsyte:
Three months ago in response to "constructive pressure" on quote from AIDS activists, Dr. Anthony Fauci of the National Institutes of Health announced a controversial new program called The Parallel Track. Until now to be approved the drug has to pass tests for both safety and effectiveness. On Dr. Fauci's Parallel Track, AIDS drugs move much faster to patients just as soon as they've passed with the initials tests for side effects on a small group of volunteers, and before they had been proven effective. While the drug is being tested in clinical trials for its effectiveness, thousands of people with no alternative therapies and who are unwilling or unable to enter clinical trials, will be able to get the drug for free through their doctors. Data on these additional people will be reported back to the FDA and the drug companies. While details of the Parallel Track are still being worked out, Tthe Bristol Myers company is making its new drug, DDI, available to thousands. The drugs been through phase one safety tests on about 100 people, some of whom who have reported potentially serious side effects. Although this is not an official parallel track program, it's considered an interim measure, consistent with a new proposal. We'll be talking about this from four perspectives, including that of a man who took the drug,in just a moment.

Cut to break. The Eleventh Hour graphic

INTERVIEW INSERT CONTINUES:

Robert Lipsyte:
Robert Lipsyte
Well, that's just the area that Grace feels muddies the waters, right?

Rebecca Smith
Patient empowerment!

Grace Powers Monaco
I like the idea of patient empowerment. I like the idea of being able to have a choice. But again, my issue is, if we don't know enough about a drug to know that it's going to be a patient benefit, and if you're not in a control trial, so that the data that you're developing is going to really help move the drug forward, is it ethical to let those patients take risks at a time when it's going to cost a great deal of money to provide this drug to people before we know it has any benefit of helping.

Robert Lipsyte:
You're talking about... money? Because I mean, Larry, in terms of taking risks and effectiveness and cost, we're talking about Larry who feels his life is being saved by being in this project, correct?

Larry Josephs:
Well, I think it's fair to say that if I had- if I were not on some kind of antiviral drug right now, I'd be at a great and growing risk of potentially deadly infection. And so I do, I do feel that it's a good thing that patients have an option. And as long as they get as much information as we can provide them, I think they ought to be able to exercise that option.

Robert Lipsyte:
Is it fair to ask him to be a hero?

Rebecca Smith:
Or a martyr? I think there's some confusion about the difference between a hero and a martyr. Basically, I don't think that it's been established that long term medical goals are incompatible with short term patient needs. I think that that assumption needs to be challenged. And the people in Washington are listening very carefully to the challenge that act up as articulated to that. If we don't have to kill people to prove that drugs work, if we don't have to exclude people from having their only options, then why should we?

Robert Lipsyte:
Well do you think, Grace, that that Larry being on this drug is condemning others to death up the road? Because we don't know exactly how these drugs are going to work?

Grace Powers Monaco :
No, Larry being- Larry is on this drug in an appropriate form to find information that's going to influence the medical process. Potentially, the way that the could be your research initiatives can be done and the Parallel Track can be done would be to give us very strong information. However, there are hundreds of thousands of patients that would want to take advantage of these options if they were out there. Right now, we don't have the funds on the federal level unless we do reprogramming, the insurance companies are not paying for it. If we can get past the ethical issues of patients agreeing to be heroes or martyrs for the benefit of science, it's not going to help us get past those issues for those patients unless we can find the funds to permit them to either take drugs on the Parallel Track, or take them through the community research initiatives or to expand the clinical trials that need expanding. I think it comes down to a question of economics.

Robert Lipsyte :
Well, you also said the magic word earlier, which is ethical issues. Carol, what about this idea of heroes and martyrs? Is this too emotional?

Carol Levine :
Well, I think that there, there is an important issue of information and consent to people, both those in approved clinical trials and those who are going to be obtaining the drugs on a Parallel Track or through a treatment IND, or through some other mechanism. Patients do have to be given all the relevant information and be apprised of all the risks. And then at a certain point for certain patients, they do have, I believe, the right to make those choices themselves. If we know that something is really, terribly risky, I would be very much more concerned that if something that looks promising, and doesn't have a lot of toxicity and an early stage, but consent is essential in this in this regard.

Robert Lipsyte:
There's somethingkind of bloodless about this, I mean, the point is that a seriously ill person and those around a seriously ill person want whatever is available and are willing to take risks to save their lives.

Grace Powers Monaco:
If they have truthful information to make decisions on, they have a right to do that. And actually, we have a very interesting opportunity with AIDS that we did not have in cancer. Outside the pediatric cancer population, we only have 3% of the adult cancer patients enrolled in clinical trials. We have 75% of the pediatric cancer patients, we're curing almost 70% of our kids, we're curing 50% or less of our adults. It could very well be, if it's handled correctly, that the model that's being put together now for dealing with AIDS, could help all areas of medical research, because it would expand the opportunities for enrolling more people in trials and having them understand the importance of this. But again, my bottom line is we have got to make a serious effort to find the funds to reprogram the funds to pay for this access. All the talk is wonderful. All the ideas are wonderful. But there is not going to be an opportunity without subsidizing the cost of trials and the costs of those drugs.

Robert Lipsyte:
Rebecca, you're nodding, you agree to that?

Rebecca Smith:
Well, basically, one of the statisticians I was speaking with about the Parallel Track earlier in the week referred to it as "one giant anecdote." There is so much that remains to be articulated about the parallel track. And I hope that it is articulated with the intentions of the framers in mind. There is so much that we need to do, we need to establish parameters for what constitutes adequate toxicity requirements before releasing something on the parallel track. We need to- Parallel Track is such a small part of the ACT UP agenda to sort of reform the medical care system. And at the heart of that issue is rearticulating the role between patients and physicians. So the patients become informed partners in their own care. We want to make that process of informed consent a dynamic process, we want to revitalize it. Parallel track provides an opportunity for us to do these things.

Show ends, credits overlay The Eleventh Hour show opener graphics.

Reel end.