AIDS: Should America Stay home?

[haggis]

I found the column interesting and couldn’t remember where Nicole posted her last AIDS related comments so I thought I’d just start one here since I suspect it will attract attention.

One of the things that I mentioned earlier was that the “world” (Europe) is frighten of the wrong thing; they pretend to be frightened by our unilateral ways (question - is it “unilateral” when no one else want to do anything and we decide to do it ourselves? I.e. Bosnia, Rwanda and hopefully, Darfur??)

The world should be very frightened that we, as a collective, will grow disenchanted with the scorn – most of it totally unfounded - and just withdraw from the world.

Our country came in to being because of our distrust of “foreign entanglements” and we remained – mainly - an isolationist country until 1941.

Do we need the world? Yes, but the world need the U.S. a hellofva lot more and they know it!

Between New York and California are a lot of Americans who have never made an international phone call and who see no real reason why they should be required to interact with the world. They’re wrong, of course, but that’s not what’s at issue.

Pat Bucannan, vile person that he is, garnered a lot of vote simply because he advocated a return to Ameica's isolationism; I suspect there are still a lot of Amerian who would vote for some main stream politician who advocates the same thing.

We give more money, private and via our government, to more poor people than most of the rest of the world combined. What happens if we stop or reduce tht amount of aid?

Do you think Europe is going to even try, much less than MATCH, what the U.S. has spent to help with AIDS in Africa and the rest of the world?

If you do, I got some property in Florida to show you.

[Selma in Sandy Eggo]

Glorious beachfront estates, just east of Bisbee...

How about if we just make the requirements for foreign aid as stringent as those for a student loan? You know, where you have to ask for the money (humiliating!), promise to either pay it back (if a loan) or do something laudable in exchange for the money (if a grant).

If this is not too hard for our citizens to do, would it really be too hard for foreigners who need charity?

The worst need, in respect to the AIDS plague, is a vaccine. But this wretched virus is a tricky one and there isn't a good one yet. I keep hoping. Don't mind supporting the research. Glad to pay for manufacture, as soon as there is a vaccine. Willing to pay for universal innoculations, wherever there are unvaccinated people. I'll kick in for care and palliative drugs to the folks who already have the disease.

But is it too much to ask, that they should ask? Maybe we are wrong to force charity on folks who don't want it.

[lliam]

What Selma said.

[lliam]

The Diana, Princess of Wales
HIV Research Foundation
==========================

The Diana, Princess of Wales HIV Research Foundation is committed to the pursuit of excellence in research, training and treatment of HIV and infectious diseases in southern Africa.
The Foundation, dedicated to the memory of Diana, Princess of Wales, has developed under the directorship of Dr Robin Wood and was opened officially by the British Consul General in 1998.
The Foundation has a strong link with Somerset Hospital, Cape Town, a hospital with a long and interesting history: it was the first teaching hospital and nursing college in South Africa and in 1994 was the site of the first dedicated HIV clinic in Cape Town.
The Foundation incorporates diverse activities in the fields of HIV and infectious disease in Cape Town. These include the HIV Research Unit at Somerset Hospital, several community based projects a health economics research and consulting service and Infectious Diseases Clinical Research Unit at the Lung Institute, University of Cape Town (UCT).

[RC]

Confucius

If language is not correct, then what is said is not what is meant; if what is said is not what is meant, then what must be done remains undone; if this remains undone, morals and art will deteriorate; if justice goes astray, the people will stand about in helpless confusion. Hence there must be no arbitrariness in what is said. This matters above everything

Webster/Miriam

Charity:...from Late Latin caritat-, caritas Christian love
1 : benevolent goodwill toward or love of humanity

Selma

If this is not too hard for our citizens to do, would it really be too hard for foreigners who need charity?

Being particular about your motives is pretty important. Charity doesn't come with strings, not even a request for assistance.

Each time we as individuals, organizations, or in the name of our country venture forth, we should be clear and honest about our goals.

Benevolence? Sometimes. But we usually have alterior motives. Thats OK as long as everyone understands what they are and has the opportunity to partake or dispute accordingly.

IMHO

[Nicole Marie]

What RC said... the part about charity not coming with strings attached.

There are two main issues. 1- Do we give money? 2- If we make the choice to give money then it cannot come with strings. If you want to change the lifestyle of people (abstinence) then fund education programs. Don't mess with peoples health and deny them AIDS treatment or protection b/c you do not agree with a culture or how they live. It's called projecting your morality. Cultures in Africa do not have the same ideals as W. You will not change generations of a culture that believe in multiple wives, genital mutilation, selling of women etc. Withholding money from a clinic will not stop it. Fund an education program or two will. But don't let people die in the mean time.

In Africa the average person lives to age 33. Over 22 million people have died. Over 40 million are infected. Over 4,000 health clinics have been closed and African countries do not have enough money of their own to keep them open. There is an epidemic of orphan children growing up without parents. The saying in Africa is, "Leave them for the hyenas". B/c orphan homes and social service groups are so over run with children they can not take all in. (I was told this by a women from Africa who runs the last clinic in her area at the March for Women's Lives in DC. Her clinic has had funding cut, all other clinic were closed and her government found enough money to keep hers open. But they have to turn away an average of 300 people and children a day b/c they do not have the resources to help them.)

There are two epidemics in Africa 1-AIDS and 2- Orphaned Children. The numbers of those that need help have skyrocketed since Bush added strings (bc clinics have closed). Sure teach abstinence but also pass out protection and drugs to help those infected.

Another aspect of Bushes rules is the money given cannot go to buying generic drugs. We all know first hand that generic drugs are a savings and work the same way. A clinic can buy more of a generic drug and treat more people then the brand name drug. You could save more peoples lives if clinics were allowed to buy generic. But Bush says no, you have to buy the brand names. (Helping out his drug company buddies? We've seen that with our own elderly in this country.)

It seems so backwards, like you are running uphill against an avalanche. And it's people’s lives we are messing with. As I said earlier we made the choice to give money. So lets give it right.

As a side note: Bush's daughter (not Jenna the other one) has a degree in Social something (the title escapes me right now) but it is a degree in assisting with AIDS survivors. After the election she has announced she is moving to Africa to assist the clinics and organizations. She recently made comments to the press that the current funding of programs in Africa could be better run. (Dis on dad? But still maybe she can help.)

[haggis]

Nicole,
Can you give the references for the above especially for the strings on the money? I would be very interesed to read up on those.

Of course we have to have some string, otherwise the money would wind up in some government minister's bank accout, but I agree that too many strings can reduce the benefical affect of the donations.

I'm still hopeful we can do something positive for Africa. I spent a lot of time on deployments to the east and west coast of Africa and saw some truely horrific sights.

Darfur should be our most immediate priority. The Arab minority is determined to eliminate all Africans from the country and have engaged in nothing less than genocide.

The rest of Europe's shameful neglect and refusal to help has already cause the issue to reach Rwandan level deaths and it will only get worse unless someone pulls the Sudanese government up short.

Unfortunately, I think it will have to be us, again, alone.

[piqaboo]

Just remember, the polio vaccine is actually purposely contaminated to cause female infertility (or so some muslim leaders would have their people believe).

AIDS vaccine - Even trickier than developing it (which is most certainly been a problem!) is testing it. HUGE issues there - like that it can only be effectively tested in 3rd world countries which dont have good palliation, and which scream discrimination if we try to stage trials there.
Some groups have managed to get good trials going - but vaccine trials are by necessity enormous. Much larger than trials for therapeutic agents.

googling 'AIDS clinical trial africa' gives some hope for vaccines in progress.

[piqaboo]

AIDS aid:
Recent news article (cant cite reference sorry) says Bush approved use of US-donated money to buy generic aids drugs for use in overseas programs.
Its a tough line to walk between "legislating morality" and the fact that sexual fidelity limits the spread of HIV better than any other preventative. Condoms work pretty darn well tho.
The Ugandan ABC program referred to before is an educational program, such as HRH advocates.

Q is - how can we market the US's huge effort and commitment to world aid so that it gets some appreciation and not only derogatory treatment?
I know we do nothing perfectly - perfection if achievable would be prohibitively expensive. And we encourage constructive criticsm to help improve what we do do, but it does get old getting only slammed.

Re those US drug companies - pricing policies could use overview, but also please to realize - developing, testing and getting FDA clearance for a new drug is astonishingly expensive. Stage I clinical trials (small scale, safety trials, usually conducted on people who have no more medical options left and who are very brave) cost millions of dollars. Many drugs drop out at this stage. If they pass, they go to Stage II - much much larger trials, where the company attempts to demonstrate the drug is in someway better than the best treatment currently available. As a side-effect, the company is paying for state-of-the-art treatment for the control group, as well as for the test treatment for hte new drug group. And, if something goes wrong, [ex: Lilly trial of a few years back where 7 participants had sudden total kidney failure in ~ a 2week period] the company pays for the therapy to try and rememedy this unexpected outcome and of course faces lawsuits as well.

So, its tough to put a company thru those hoops, then ok instant access to generic versions of the drug it took so much money and time to develop.

I agree that Africa, India, possibly Thailand should use generics for now - their gov'ts have responsibilities to their people. Perhaps its a good thing Viagra is so widely purchased - it can amortize the cost of the next cancer or AIDS drug.

[Nicole Marie]

Hey Piq--

That article just came out today after Bush was slammed at the 15th interantional AIDS conference going on right now. But be aware, it's not a done deal. And if it goes through generic companies must first file with the US, be approved, have the drugs approved and then the drugs can be purchased. That will take months if not years. But the US is limiting the number of generic drugs in a purchase to 100,000. So if you need more then that amount you are SOL.

To touch upon what you stated earlier. My aunt works for Lords of London. They are an international blood monitoring company. Her area is South and Latin America and parts of Europe. She watches countries that house blood for public use and companies that use blood in testing (like AIDS). Part of the reason a vaccine cannot be found is b/c AIDS is SMART! It's like a biological weapon. When it gets use to a vaccine or some drug designed to kill it, AIDS will mutate its self and reform into a new strand that is immune to the drug. Since the late 80's (when companies became really serious about a vaccine) the AIDS virus has mutated 28 times. So we have at least 28 known new strands of the AIDS virus and then subcatagories from there. It makes finding a cure almost impossible.


Haggis:

Great web site:
http://www.theglobalfund.org/en/

CNN did a big story yesterday from the 15th International AIDS conference going on right now in Bangkok. You can find out what leaders in the field are saying: http://www.aids2004.org/


http://www.medicalnewstoday.com/medicalnews.php?newsid=10765

http://www.commondreams.org/headlines04/0330-02.htm

http://www.globalpolicy.org/socecon/develop/aids/2003/0601allies.htm

http://www.globalpolicy.org/socecon/develop/indxaids.htm

http://www.50years.org/cms/ejn/story/74

<small>[ 07-15-2004, 01:35 PM: Message edited by: Nicole Marie ]</small>

[RC]

Only point in being specific in regards to motives has to do with a comparison of this specific foreign aid, (AIDS), to a student loan...

What do you expect in return if it is charity?

Not to say that offering "charity" in the form of abstinence/condom education is not "charity". If you haven't already popped out to look at the Uganda story, it deserves a couple of minutes of study.

It would be exceedingly difficult for the US to offer this kind of education without getting accused of some sort of hegimony because we haven't always been altruistic, (who has right?, but we're really visible aren't we).

I believe that our efforts in Somalia were truly altruistic and look how that turned out.

Sometimes I think other nations see the US as a sort of older sibling, responsible for everything (rightly or wrongly), and often envied and despised for its power and decisions.
You just are never going to come out smelling like a rose.

That doesn't mean your responsibility ends.

[piqaboo]

RC - I think you are right re envy being a large part of the "dissing". And, I agree that charity comes with no strings attached, but I also think the charitable money can be spent "teaching a man to fish" (or teaching him how to choose not to get AIDS).

Originally posted by Nicole Marie:
Hey Piq--

That article just came out today after Bush was slammed at the 15th interantional AIDS conference going on right now. But be aware, it's not a done deal. And if it goes through generic companies must first file with the US, be approved, have the drugs approved and then the drugs can be purchased. That will take months if not years. But the US is limiting the number of generic drugs in a purchase to 100,000. So if you need more then that amount you are SOL.

In scratching back, I'm sure I heard the news on the radio - either Tuesday or Wed this week.

YRH, some of these are not easy drugs to make. If we want to ensure they are fully potent, etc, we need to ask for this kind of process review and testing. Otherwise substandard garbage could easily get to market. Thats no more than we ask for manufacturers of generics to be sold in the US. Do we want less for the people of other nations? I hope not.

There is no rule against multiple purchase orders.

originally posted by HRH
To touch upon what you stated earlier. My aunt works for Lords of London. They are an international blood monitoring company. Her area is South and Latin America and parts of Europe. She watches countries that house blood for public use and companies that use blood in testing (like AIDS). Part of the reason a vaccine cannot be found is b/c AIDS is SMART! It's like a biological weapon. When it gets use to a vaccine or some drug designed to kill it, AIDS will mutate its self and reform into a new strand that is immune to the drug. Since the late 80's (when companies became really serious about a vaccine) the AIDS virus has mutated 28 times. So we have at least 28 known new strands of the AIDS virus and then subcatagories from there. It makes finding a cure almost impossible.

Yup, AIDS is a booger alright. I've working on detection assays for it for "nigh on" 20 years now, using different technologies. Detecting it is quite simple compared to clobbering it. Its a sneaky little booger indeed, and our desire to conquer it has funded a lot of research that changed pharmacology, diagnostics, therapeutics, etc in so many fundamental ways. This one "enemy" has lead to huge advances in our scientific knowledge and bags of tools. Before AIDS, we were pretty complacent with our antibiotics and vaccines, and werent spending much energy on viral therapeutics. A sad sort of silver lining.

[Nicole Marie]

Piq-

The generic drug thing was presented at the 15 International AIDS convention. The administration came out today stating it. I heard it on CNN as being released today from the administration.

Generic does not mean it is less effective. Generic means it does not have a big name company attached to it. Generic means the patent on the original drug is over and now anyone can make it. It means it is approved for the US and for other countries but that the original patent holder no longer holds rights over it.

Example: With until Viagra runs out. We will then have "generic" versions of it around. Yes Viargra will still exsist but companies will be allowed to use the specific combo of the current Viagra drug and make a differnt/same pill but will not be able to call it Viagra. But bc Viagra is so will marketed the public knows it as the erection pill. So future companies will make "generic" versions of Viagra and call it that. No need to spend money on re-marketing a different name when it's the same pill. Just call it generic bc the makers of Viagra have already done the marketing for them.

Furhter more, ask a person living with AIDS if they really care if it's generic or not? They don't care as long as it works.

<small>[ 07-15-2004, 03:24 PM: Message edited by: Nicole Marie ]</small>

[piqaboo]

YRH - you've hit the nail on the head - the generic HAS TO WORK. As expected. Every time. Just like the original, tested-to-well-past-the-end-of-its-life version.

Many drugs are made by complex chemical/biological processes that need tight control to produce reproducible, stable and potent product.
For example, I can sell you "Vitamin E" mixed D & L enantiomers. Only one of the two is biologically active. I could sell you a pure pill of the wrong enantiomer,and it would not act like Vit E in your body. It would be a waste of your time and money. It might even be toxic. But chemically, its identical to Vit E - its just the mirror image. In a test tube, it will act like Vit E, but not in the biased system that is the human body. That system has preferences.

So, the AIDS person might not care if its generic, but dollars gets you donuts they care if it works. And they care if they are getting the right dosage.

BTW- Im very aware of the definition of generic. It has nothing to do with patents. Its just that most generics cant get made until patents expire. Thats cause and effect, not definition.
See FDA definition: FDA WebPage

I dont think we can let people manufacture generics without oversight. The world is too full of those who want a quick buck. Some folks would do the best they could and make good drugs. Some would do the best they could, and make garbage, and some folks would sell sugar pills as the latest molecular biology breakthru etc.

Re the announcement - we must have good radio in SoCal then, because I neither read the paper nor listened to the radio this morning.

[Nicole Marie]

Piq-

You and I are talking on two differnt issues. You are addressing the proccess of generics and I am addressing the right to buy generic.

Brazil has had outstanding success with generic drugs. There are generics that work. Our FDA is so slow at approving drugs. There are many countries that use generics with great success. So do we tell Africa with millions suffering "No you cant have them. They work for other countries but we have not gotten around to testing them yet."? It should be up to the clinics and countries how they treat their citizens. We have US citizens that leave thisi country for treatment bc we are so slow at introducing new drugs. I don't think we should put people who have other options under the same fate.

<small>[ 07-15-2004, 04:04 PM: Message edited by: Nicole Marie ]</small>

[piqaboo]

YRH,
I'm not sure why you are arguing this point with me - we agree.

originally posted by piqaboo 7-15-04 1:18 pm I agree that Africa, India, possibly Thailand should use generics for now - their gov'ts have responsibilities to their people.

You just seem to feel that the generics should be totally unregulated. I dont. My opinion comes from 20 years in the biotech/pharma/diagnostic/healthcare industries. I know how easy it is to make a bad manufacturing process.

[piqaboo]

We have people who leave this country because we are slow at introducing new drugs, like thalidomide.

I wont argue the FDA isnt slow. It is. Its gotten a LOT faster since mfger's started paying fees to have applications and data processed. That gave the FDA the budget to hire enough people to do the job.

The trade off is time to approval (including preapplication clinical trials etc) vs safety and efficacy.

Why should I, as a developer and manufacturer of brand name Anti-AIDS drug "X", allow you, the unregulated OUS manufacturer of generic "X", call your drug as being the same as mine, just on your say so? Why on earth shouldnt you have to prove it? Proving equivalence is MUCH faster and easier than approval for a new drug.

If you want to "steal" my drug, make your own version, and not show that they are the same, then get your own name, do your own trials and take your own risks. In whatever country will allow you to do so.

[Nicole Marie]

Ummm Piq? I'm not arguing with you. Calm. And I never said generics should not be regulated. Of course they should. I would hate for someone to get the wrong drug. I just think our patent rules, current FDA rules mess up the aproval system. It takes to long and people die waiting. I also think we should not tell countries that they can not buy the same generic drugs that are working for other countries like Brazil. We are asking Africa to wait to purchase when the drugs are already proven. It is a life and death issue and no one should be asked to wait so some guy can put a rubber stamp on it when it's already in the market and approved.

<small>[ 07-15-2004, 04:41 PM: Message edited by: Nicole Marie ]</small>

[piqaboo]

Feel free to substitute "discuss" or "talk" or "say" for "argue".

I wish I could say we have no say over where Africa (or India, or Thailand) spends its own money. We only have a say over where we spend ours. (But of course, we do have power, in whether we continue to trade with those countries.)

Who "approved" the Brasilian drugs? By what standards?

I can see both sides of the issue of whether our charitable dollars should be spent a) on the brand name original US (or Swiss, etc) developed drugs - to support our own economy and laws, or b) on generic Brasilian / Indian etc versions.

I'd like to know if you would take drugs for yourself or give them to hypothetical future offspring, if they went thru a less rigourous process than the FDA? If you lived 20 miles from the border, would you buy antibiotic generics made in south america? Remember that thalidomide was approved for use in Europe. And all it took was one dose in the first trimester to wreak its havoc.

Would you approve an increase in your taxes so our govt, like NZ's, can pay the drug companies to develop drugs just so they can be genericized immediately?

the FDA does give us huge hurdles - the last "abbreviated" submission I helped with was for a screening assay (easier than for a drug), and when I stacked the volumes, they made a 6' stack. Thats a lot of work and time.

One point re "time" - the FDA only lets you claim stability for your product that you have actually demonstrated. If you want it to have a 1 year shelf-life, you have to have shown it to be stable for MORE than one year.
There is no way to make that year go by faster, so you can get to market faster.

I think one thing we need is much better distribution systems within the countries where we are charitably active. Then we can take "near end of shelf life" drugs from manufacturers, who will often give them away for the tax write-off, and get them to the folks who need them - quickly - before they expire (the drugs or the people. double entendre was unintentional. Am ducking for cover).

Me - I am not taking anything that was made in South America if I can help it. Call me a medicine snob.

[Nicole Marie]

I understand that point Piq. But Brazil approved drugs based on standards they put in place that they felt were best for their citizens. It's the same thing the FDA does for the US. Who standards are best? It should be left up to each country. If Africa wants generic let them have it. If it works for others and it's been proven in other countries, why does it matter?

We are almost saying the same thing. You don't have to take a drug you feel may not have been tested well enough. But if I was suffering from AIDS, I really wouldn't care. I volunteer for a local AIDS group. I have met several people who have left the US to try a treatment not approved in the US. I will not stand in their way. Once the cocktail fails you are screwed, you have no other options. Hell yes, I'd try something, anything! You're dead either way.