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HIV Vaccine

The Sexecutioner writes "WebMD is reporting on a new vaccine which has had an incredible effect in clinical trials. The vaccine, composed of human dendrites holding dead HIV viruses, has dropped test patients' viral load by up to 90% in one year. Could this be it?"

34 of 848 comments (clear)

  1. Mixed feeling by fembots · · Score: 5, Insightful

    While I am glad that we may have found the cure to HIV that kills millions every year, I wonder if the vaccine will be affordable to those unfortunate ones?

    I got a feeling that only those wealthy people can afford to get fixed up, but most of them caught HIV due to their irresponsible action. Yet innocent victims who caught the disease, for instance by birth, may never see the light.

    It seems like most medical findings are "open-source", that you can read about them in journals, but the actual cost to produce a medicine is usually very prohibitive.

    1. Re:Mixed feeling by Skyshadow · · Score: 4, Insightful
      First, I think it's way too early to think this is a cure for HIV.

      Aside from that, when you RTFA you'll see that this isn't a regular drug, it's more of a therapy -- as I understand it, you use cells from the patient's own body and basically train them to combat the HIV virus. Unless you can create a generic version that would work across populations, it's not as simple as just shipping a bunch of shots off to the third world like we were able to do with polio.

      As for "open source" drugs: You should realize it isn't that simple. It costs a lot of money to find, test and approve new drugs. While I'd agree that our current system enriches the drug companies at the expense of the little people (among a myriad of other problems), it's really important not to assume you can think of the industry like you do computing.

      --
      Every year during my review, I just pray the words "slashdot.org" aren't mentioned.
    2. Re:Mixed feeling by YU+Nicks+NE+Way · · Score: 4, Insightful

      Sorry, but that just isn't true. The truth is that identical drugs, made on identical lines, cost more in the US than they do in Canada. Why? Simple: the prices in Canada are negotiated by customers who have the time to study the actual costs of production, and who aren't desperately begging for the treatment right now. The result is drug prices which are genuinely negotiated between producer and consumer, rather that prices set by a producer with no feedback from a market.

      That is to say, the lower prices in Canada are due to exactly what most opponents of socialized medicine claim to support: a working market with multiple, informed customers.

    3. Re:Mixed feeling by Hortensia+Patel · · Score: 4, Informative

      If it's effective, it will be affordable, one way or another. If the maker sets the price too high and governments or aid agencies don't step up, the demand will be met by the generics makers, and governments will turn a blind eye as necessary. No amount of flak about "respecting IP" outweighs a quarter of your population dropping dead.

      I wouldn't be surprised to see the Bill & Melinda Gates Foundation get involved here, too. Say what you like about Bill, the Foundation has done some good work in this field, and he's not short of the shekels.

    4. Re:Mixed feeling by flossie · · Score: 4, Insightful
      The only victims of HIV are those who got an infected blood transfusion by "mistake".

      So you don't class babies born to HIV+ mothers as innocent?

    5. Re:Mixed feeling by lavaboy · · Score: 5, Informative

      Actually, the vaccine is being designed for use in countries where conventional therapy is simply much too expensive. It can be kept at temperatures up to 50 degrees (C) for up to 2 years - which, together with the fact that it seems to only work against the HIV-B strain (most common in Africa), seems to indicate that it is headed for sub-saharan Africa. One of the doctors following / contributing to this project gave a presentation on it at the Munich AIDS Days seminar last week. Although the stage one trials on people are showing some progress, the processing involved (own cells, own virus) still makes it kind of prohibitive - i heard that the time frame for wide-spread therapeutic use is 5-10 years.

      The unfortunate fact is: it isn't a cure, but a management therapy which should allow infected people to live longer, more productive lives. Even worse - the pharma corps seem to be losing interest in designing new drugs - there hasn't been anything new for about 3 years now... No money in it, especially now that the UN and various charities are clamoring for reductions in trademark and other IP law restrictions. Good for HIV+ persons in poor countries, bad for the pharmacorps bottom line...

      --
      Steve -- If you have to call it a system, you don't know what it is.
    6. Re:Mixed feeling by Eric+S.+Smith · · Score: 4, Insightful
      (it was too stressful with the thread of aids)

      News from the future: incidence of all other STDs skyrockets.

      Sigh.

    7. Re:Mixed feeling by Anonymous Coward · · Score: 5, Insightful

      most of them caught HIV due to their irresponsible action

      Begging your pardon, sir, but I have HIV and I didn't get it through irresponsible action. I received the virus through an unfaithful wife, with whom I believed I was in a monogamous, long-term (10+ years) relationship.

      I realize that your sheltered existence makes it easy for you to dismiss the majority of the millions who suffer from HIV as irresponsible, but I'm here to tell you, it's not always so, nor do I find that most cases (at least that I know of through the support groups) are caused by irresponsibility.

      Just think about this before you dismiss "most" of HIV sufferers. I did not engage in dangerous activities. I was not an intravenous drug user. I did not engage in homosexual sex. I didn't apply medical care to an HIV patient without appropriate protection.

      I had sex with my long-term partner. And now I'm left to die, knowing that I never stepped beyond what was "safe".

      HIV is a terrible disease, and it can affect anyone. Chalking a majority of infections to irresponsibility is facile and dangerous. Nobody is safe from this terrible, terrible disease.

    8. Re:Mixed feeling by fupeg · · Score: 5, Interesting
      Simple: the prices in Canada are negotiated by customers who have the time to study the actual costs of production, and who aren't desperately begging for the treatment right now.
      This is so completely false that it is not even funny. First off, price ceilings are affected in Canada by its Patented Medicine Prices Review Board. Second, drug distribution is controled by the provinces through each province's list of approved drugs, known as the provincial formulary. If you're not on the formulary, chances are you're not going to be sold in that province. The provicne then negotiates the prices of drugs on the formulary. This has allowed Ontario to freeze the prices on all formulary drugs since 1994. Customers do not negotiate the prices, the government does.

      However, the biggest reason drugs are cheaper in Canada is because per capita income is about 20-30% lower in Canada than in the US and there are drug trade barriers between the two markets. If there were no barriers, then the prices would equalize across markets since one could buy a drug in Canada and sell it in the US. But with barriers, drug companies can easily set different prices in different markets, charging their richer customers (US) more than the poorer ones (Canada.) This is a classic monopolist tactic known as differential pricing. Ultimately it is the lower income caused by socialism in Canada and free trade barriers between the countries that cause such a large price disparity.
    9. Re:Mixed feeling by pjt33 · · Score: 4, Insightful

      Two people have already poked holes in your claim, but I'll add a third hole by pointing out that a woman who contracts HIV from her husband after he acquires it from another woman is certainly a victim.

    10. Re:Mixed feeling by cindy · · Score: 5, Insightful

      The article you link to doesn't even mention Canada, Canadian laws, or the Canadian drug market. How exactly does this support your argument?

      It's a FUD piece supporting drug patents. I liked this quote...
      Patent pirates, however, want to steal even more of a drug company's property. Their justification is the need for "humanitarian" aid. They offer the notion that it is unethical for companies such as GlaxoSmithKline, Roche and Pfizer to put their patents and profits above the suffering of those in Africa and other needy places who are afflicted with HIV, malaria, tuberculosis and other treatable diseases.

    11. Re:Mixed feeling by ScrewMaster · · Score: 4, Insightful

      It's more general than that. Because we have middlemen (insurance companies) that sit between us and those paid to provide our health care, the cost of said care has been successfully divorced from our ability to pay. How much do you think your local mechanic would charge if your car insurance company paid the bill?

      Everyone talks about Canada's "socialized medicine" being so different in principle than the United States', but really, when you think about it, that's exactly what an insurance company is supposed to be! It's a socialist concept from the beginning. Few can pay the actual cost of significant health care, so everyone pays into the kitty, and those in need take out. Not so different, in principle. The problem is the people in charge of that kitty. Note that both the middlemen and the health care providers in this country are profiteers, and that applies as much to state-run programs such as Medicare and Medicaid as it does to private organizations. The drug companies are one of the most public examples of medical profiteering, but there are many, many more. Actual health care is no longer the primary focus of the United States medical system. Like so much else in this country, the prime function of the medical system is to transfer wealth from one group to another (much smaller) group. Which is great, I suppose, if you're part of the latter group. I'm not, so I don't like it.

      You would think that insurance companies would try to find ways to keep costs down by putting pressure on medical suppliers. But they don't. They don't have to. They simply keep their rates as high as the market will bear (and beyond) and then do their level best to disqualify anyone they can from actually receiving any care. And that was before HMOs came on the scene. The result has been yet another group of murderous corporations that are so flush with money, and complicit in the deaths of so many people, that they almost make the tobacco companies look angelic.

      --
      The higher the technology, the sharper that two-edged sword.
    12. Re:Mixed feeling by Various+Assortments · · Score: 4, Insightful

      Generic drugs in the USA are almost as cheap as the generics in Canada. It's just that Americans don't trust generics, as they see them as inferior.

      The generics in Canada are only produced after the patent expires, ie, 20 years. I don't know where you got the ridiculous idea that Canada doesn't respect US patents, but it's utterly ridiculous and ignorant. Next you'll be claiming Canadian drugs are unclean and manufactured with lacking production controls. Another myth perpetuated by the US pharmaceutical companies who see Canada undercutting their costs and stealing their mojo.

    13. Re:Mixed feeling by jadavis · · Score: 5, Insightful

      I think our philosophies are very different, but your observation is very true. Insurance companies ARE very similar to socialism.

      The problem is that medical insurance became widespread when companies started offering health plans in lieu of pay.

      Everyone has some basic levels of medical costs: vaccinations, pediatrician visits for their children, eye care, dental care, occasional medical situations (perhaps a broken bone or infection), etc. If you buy insurance against something that everyone knows will happen to you, then the only result is that the insurance company wins big time, just like Las Vegas: they know the numbers and they know that they will win.

      What you buy insurance against are the high costs that you probably won't suffer, but would create a hardship if you did. These include tragic accidents that are rare but require hundreds of thousands of dollars to fix, or bizarre diseases or something.

      What we have is a situation where basic medical needs are being covered by insurance, which means the customer is always losing (just like if you spend enough time at the blackjack table).

      The only thing that makes sense is to drop the insurance policy that you lose out on, and get a cheaper policy that only covers the big stuff. Then pay the little stuff yourself.

      Then you also benefit because your premiums aren't covering the costs of high-risk lifestyles of other people. The insurance companies can't discriminate and charge those people more, sometimes because the law won't let them (i.e. they can't charge more to gay people) and sometimes because they don't know (druggies or something).

      --
      Social scientists are inspired by theories; scientists are humbled by facts.
  2. Wait, a vaccine? by Skyshadow · · Score: 4, Informative
    I'm confused about the terminology: If it was used on patients who already had HIV, wouldn't that be a treatment rather than a vaccine? Or does the way if works -- apparently reconfiguring the immune system to recognize HIV -- technically qualify it as a vaccine since that's basically how vaccines work?

    I'd imagine that this sort of therapy could be useful against a whole range of viruses since (as I understand) it operates by training the immune system rather than crippling something specific to the virus the way that other HIV treatments do. If that'd work for most viruses, maybe someday people will be able to just update their own virus definitions a few times a year -- of course, most of them probably wouldn't bother and then call me for support when they open some damn .exe file they got in their friggin' email and... Sorry, started drifting there for a second.

    Of course, it's awfully early to get too excited given this is just 18 people in Brazil so far, and "incredible effect" might be a bit strong since only 44% of the very small number of test patients are still showing the full benefit after one year, but I suppose any good news in this sort of scenario is, well, good news.

    PS: Am I the only one who finds it darkly ironic that "The Sexecutioner" submitted this story?

    --
    Every year during my review, I just pray the words "slashdot.org" aren't mentioned.
    1. Re:Wait, a vaccine? by Bastian · · Score: 5, Informative

      It's considered a vaccine when you're inoculating the patient with live or dead specimens of the pathogen with the goal of getting the patient's own immune system to handle the disease on its own.

      In this particular case it's being used for therapy rather than trying to give someone immunity to a disease, but it's still a vaccine.

    2. Re:Wait, a vaccine? by grunt547 · · Score: 5, Insightful

      Seriously, curing HIV is just dealing with a symptom of a problem. If the groups that promote AIDS and STD education in Africa could get just a tiny portion of the funding that goes into HIV medical research, the spread of AIDS would run into a wall. In South Africa, they have billboards that say things like "You can catch AIDS by having sex with an infected woman." Americans think, well, no kidding, but very few people have bothered to tell the South Africans that. AIDS is a problem that has to be attacked on all fronts.

  3. THERAPEUTIC vaccine. by Shag · · Score: 5, Informative

    You''ve got to have that word in there.

    It's a vaccine because it "teaches" the immune system how to deal with HIV - at least to the extent of keeping it from getting worse, and in some percentage of cases, enough to drastically lower the viral load and rate of transmission.

    But it's not a PREVENTIVE vaccine like most widespread vaccines, and it can't be mass-produced since it uses material from each patient and is custom-made for them.

    It's still potentially a great leap in terms of treatment of HIV/AIDS, though.

    --
    Village idiot in some extremely smart villages.
  4. Welcome to capitalism by violet16 · · Score: 4, Insightful

    Well, it's a trade-off: we want private companies to invest billions of dollars to develop medicines we need, but they'll only do so if there's the potential for profit. If there isn't, capital will flow out of drug companies's R&D budgets and into car manufacturers or something.

    Governments that want to make a new life-saving drug available to all, not just those who can afford it, are free to subsidize it. Citizens and governments in wealthy countries who want to make the drugs available to citizens of poor countries can likewise fund it.

    It's easy to paint a company as horrible because it wants to charge a lot of money for a life-saving new treatment. But in many cases that treatment wouldn't exist if the company couldn't make money from it.

    1. Re:Welcome to capitalism by Rei · · Score: 4, Informative

      I wish it were that simple. Unfortunately, drug companies only spend a small amount on R&D - in "The Truth About Drug Companies", Dr. Marcia Angell discusses how on average drug companies spend 2.5 times as much on advertising as they do on R&D. Furthermore, 1/3 of the drugs being marketted by the major manufacturers were discovered by universities or small biotech firms, but are being sold at greatly inflated prices.

      For example, Taxol was discovered by NIH, but has been sold by Bristol-Meyers Squibb for 20 times what it cost to produce, and NIH only gets 0.5% royalties. Most drugs that the drug industry itself develops are what she calls "me-too" drugs - drugs that perform the same function as an already extant drug on the market with little difference, and often are based on the same chemical formula with minor modifications. They need not be more effective than current formulations in order to be able to be sold - just more effective than a placebo.

      The top 10 pharmaceutical companies make more money than the rest of the Fortune 500 combined. And not only are they granted a limited monopoly, but they often cheat. For example, Astra-Zeneca, when their exclusive rights to Prilosec expired, patented a combination of Prilosec and an antibiotic, and then sued a manufacturer of generic Prilosec because a doctor might proscribe it along with an antibiotic and thus infringe on their new patent.

      --
      "99 dead duelists of Dios on the wall. 99 dead duelists of Dios! Take one's ring, pass it around..."
    2. Re:Welcome to capitalism by Maniakes · · Score: 4, Insightful

      on average drug companies spend 2.5 times as much on advertising as they do on R&D

      Part of the advertising spending is dead weight, but not all of it. Advertising does have the effect of making potential customers aware that there are drugs that treat their conditions. How much benefit does a drug do if nobody knows about it? Before you say the doctors will tell their patients, remember that drug companies telling doctors about their drugs is still advertising, and remember that not everyone goes to a doctor over every ailment, especially if they mistakenly think there is no treatment.

      1/3 of the drugs being marketted by the major manufacturers were discovered by universities or small biotech firms

      Then I take it 2/3 of drugs being marketed by the major manufacturers were developed internally. And how did the manufacturers get the IP rights from the small biotech firms? If they bought the rights or pay royalties, then they are paying for the research that went into the drug plus the firm's profit. I doubt all small biotech firms are as dumb as the NIH was with Taxol.

      Most drugs that the drug industry itself develops are what she calls "me-too" drugs

      "Me-too" drugs limit the ability to abuse the limited monopoly by acting as competitors. That's a Good Thing. Or should everyone still be using Mosaic because all other browsers developed are "me-too" software?

      They need not be more effective than current formulations in order to be able to be sold - just more effective than a placebo.

      If a drug doesn't provide benefits in effeciveness, side effects, interactions, or price, most doctors won't prescribe it. Doctors do have easy access to reference material on all these factors, and part of what they're paid for is to know how to evaluate which drug is best for which patients.

      The top 10 pharmaceutical companies make more money than the rest of the Fortune 500 combined.

      Good. How much is a few more years of life worth to you? Or not being impotent? Or relief from chronic pain? And if it's not worth to you what people are paying, switch to an insurance plan that doesn't cover prescription drugs and opt out of the whole affair.

      And not only are they granted a limited monopoly, but they often cheat.

      This part is genuinely lame. IP law need fixing to limit these kinds of abuses.

      --
      A legparnasom tele van angolnaval.
  5. Re:hold on there by nucal · · Score: 5, Informative

    They are talking about dendritic cells which are a component of the immune system - not neural tissue.

  6. Worth reading the article... by ramk13 · · Score: 4, Informative

    to catch the things that aren't in the summary.

    This isn't a generic vaccine that's created in mass and given to everyone. The 'vaccine' is generated using viruses and dendrites from the specific patient. So it has to be done for each person. It reduces viral loads, but doesn't eliminate the infection.

    Still it sounds really promising, but there's a LOT of work that would need to be done before this got anywhere close to general use. Also the article doesn't say how complex/expensive the process is per person. It doesn't sound like it's third world friendly, at least at the moment.

  7. 90% drop misleading by jackelfish · · Score: 5, Informative

    While this study (Nature Medicine Advance On-line publications Subscription required) shows promise, it is only a preliminary trial that included 18 participants. Sixteen of the participants were female and two were male. The figure stated in the /. article, of a 90% total drop in viral load, is not quite accurate. The article states that the patients plasma viral load levels were decreased by 80% (median) over the first 112 days following immunization. It then goes on to say that a prolonged suppression of viral load (up to 1 year after inoculation) of 90% was seen in only 8 individuals.

    From my analysis of the HIV RNA expression data from this paper, after 1 year, eight of the patients had viral loads reduced by 90% or better, two patients had their viral loads reduced between 80% and 90% six patients had viral loads that were reduced somewhere between 10% and 50% and two of the patients actually had an increase in plasma HIV RNA levels.

    --
    "When Nature Calls We All Shall Drown" Johan Edlund
  8. Re:What's a dead virus? by fireduck · · Score: 4, Informative

    a dead virus is one that is no longer infective. your description of a virus is accurate, in that they are protein shells around genetic material (most of them, at least, some have enzymes in there and/or different shells)

    From what I gather reading the actual article abstract, they're inactivating or killing them with a compound that breaks off small portions of the capsid (general idea abstracted here), but leaves the majority of the capsid intact. The slightly damaged capsid is unable to initiate infection, giving the host time to mount a defense against the real thing.

  9. Practical Explanation? by katharsis83 · · Score: 5, Insightful

    Let's apply Occam's Razor here.

    On one hand, we can claim that the West created a virus designed to kill Africans, but yet still somehow manages to kill millions in North America/Europe; not particularly effective from a genocide point of view.

    Another, perhaps more practical point of view, is that sex education and safe-sex practices are far less common in Africa. The lack of knowledge about STD's and the absence of the rule of law in many parts of Africa would make a far more effective explanation.

    If we take Ms. Maathai's explanation, then food must obviously also be a genetically engineered weapon, since millions more in Africa die from starvation than those in the West.

  10. Forget about it by FiReaNGeL · · Score: 4, Insightful

    Great idea : it may be of use for patient with resistance to all known anti-retrovirals. But...

    It is NOT a vaccine. It is NOT a cure. It's a temporary (at best) treatment. The title is highly misleading. And its far from practical. You need to isolate dendritic cells from an (infected) patient, which is costly, require specific equipment and isn't trivial (forget developing countries, which can't even afford AZT). Then you pulse these cells with killed HIV, which I assume should come from the patient (else soon the treatment will go ineffective due to mutations acquired by the virus) and you reinject the cells, which will go 'alert' the immune system that something is wrong. So mass scale treatment is out of question. Basically, you're only boosting the (ineffective) immune system against HIV-1. After a year, their treatment reduced viral load by 90% in 8 of 18 patients. 90% isn't a lot (anti-retroviral do a lot better than that), and they aren't even achieving 50% success after a year. I would imagine that after 2 or 3 years, the success rate is even lower. And the CD4 count is stable, not increasing to normal levels.

    So no, its not 'it'. Don't hold your breath either.

  11. Re:What's a dead virus? by SmurfButcher+Bob · · Score: 5, Funny

    Think of it as a Windows install disk that's been badly scratched.

    --

    help me i've cloned myself and can't remember which one I am

  12. you forgot patents! by crabpeople · · Score: 5, Informative

    thats not entirely true either. i happen to work in the canadaian pharmaceutical industry and i would say that the no 1 reason that Canadian drugs are cheaper is that US patents run longer than Canadian ones. So a medication like fosamax can have a generic in canada a few years before the US industry can start producing one.

    I dont work in the legal department, but i believe Canadian drug patents are good for ~5 years and US patents are ~8 years. after that time, companies like novopharm and other generic producing companies, can start churning out generics. even the big brand name companies (ie pfizer) have generic producing lines. this is primarily for overseas markets. in fact, alot of drug companies will manufacture the same drugs, with different names and pill shape/size, based on whatever region they are marketing in. a good example of this is reactine/zyrtec. those two medicines are the EXACT same. in canada however, you dont need a perscription for it an its called reactine. the length-of-patent experation numbers might be off but alot of the lower cost can be put squarely on the messed up US patent system.

    Countries like New Zeland and the UK also have similar patent laws.

    I have also heard, that the comapnies in fact do price medication higher in the states because they feel that thats what the market will bare. I dont think that the grandparent was that far off from the truth.

    --
    I'll just use my special getting high powers one more time...
  13. Re:Mmmm! by Combuchan · · Score: 5, Insightful

    Erm. The same company that devloped Vioxx also devloped Ivermectin (Mectizan), a highly effective treatment plan (once every 12 months) for River blindness, a dehabilitating disease that affects people who can't afford modern medicine. Despite Merck dumping about $290 million into developing the treatment, they give it away for free.

    Before you attack Merck with pitchforks and torches in hand, you ought to realise that this company has an unprecedented history of philanthropy, and it saddens me to know that somebody at that company with their eyes in profit instead of the Right Thing screwed up so royally with the debacle we know today as Vioxx.

    Whatever happens with that company, I hope that at least some of their positive ideological foundations are continuted.

    --sean

    --
    "[T]he single essential element on which all discoveries will be dependent is human freedom." -- Barry Goldwater
  14. Education is definitely not stressed enough. by WebCowboy · · Score: 4, Insightful

    The development of an AIDS vaccine is wonderful news for sure, but it is still not a cure at this point (it is only a treatment that keeps the disease at bay at this point). What's at least as important (if not more) is education as you have pointed out.

    The problem is getting the third world (where the epidemic is most serious) to accept western medicine. Westerners think African-witch-doctor medicine is a bunch of bunk--well Africans have the same opinion of much of western medicine. Even if this vaccine WAS a cure, getting poor, illiterate Africans to accept treatment would require a lot of education and convincing (not to mention money that most of these victims do not have).

    The most perverse myth in some African cultures is that STDs (including AIDS) can be cured in men by having unprotected sex with a virgin girl. I shudder when I think about how many HIV+ men there are in Africa who think they are cured because they have done this, but in fact may have infected some young woman and the child she might have conceived as a result--then in the mistaken belief that they are cure go on to infect other sexual partners. Somehow putting that myth to rest would do more to combat AIDS than the most expensive drugs currently available.

    There is even a problem in the "educated" west too--it is that we are perhaps TOO educated (but in the wrong way). All this emphasis on advanced treatments for AIDS is making some people perceive the disease as no longer a death sentance but rather a chronic disease. The attitude when engaging in risky behaviour is becoming "Uh oh...I might have exposed myself to HIV...oh well, nowadays HIV is treatable like hepatitis and herpes--it would be a pain in the ass to have to treat it but I'll live alright anyways".

    The homosexual communities of large metropolitan areas are already having to combat this attitude (having previosuly become the most educated/aware segment of society concerning AIDS) and if we aren't careful the rest of the public will start believing this too. In actual fact, even if a person could live a normal lifespan with HIV, delivering a vaccine cusomised for each recipient and treating symptoms with an expensive regimen of drugs would be another big burden on the healthcare system, not to mention that the quality of life would be permanently reduced even with todays treatments.

    Yes, this is an important development, but without education and empasis on personal responsibility AIDS won't go the way of smallpox any time soon.

  15. Re:FDA approval? by sugar+and+acid · · Score: 5, Interesting

    Well the real cause for concern with the latest scandal with drugs and the FDA is a fundamental problem of pharmaceutical companies continually trying to reinvent the wheel by making new drugs to treat highly common cronic diseases with treatments that are just as effective already ( eg long term prevention of heart disease, athritis, obesity, depression, sleeping disorders), with often a "me to" approach of producing new drugs that work similary to drugs from another company (notice the explosion in erectile disfunction drugs after the introduction of viagra.

    In the case of vioxx, the treatment was designed for anti-inflammatory pain relief in arthritis, by inhibiting an enzyme COX2. It is about as effective as another drug many of us have taken ibuprofen (Advil) for this purpose but instead of being 3-5 bucks for a bottle of 50 to 100 pills, it was sold at ~$2 a pill (it is also how aspirin works to relieve pain as, thus the running joke that the pharmaceutical companies had invented the $2 apirin).

    So what was so much better about vioxx that it was developed, FDA approved and prescribed by doctors.

    Well it doesn't inhibit another enzyme COX1, like aspirin and ibuprofen do. Inhibiting Cox1 has several effects, the two most important are: the negative effect, gastrointestinal problems like stomach bleeding and ulcers; but it also has a positive effect which is prevention of blood platelet aggregation which prevents blood clots, heart attacks and strokes. This is why aspirin is taken to prevent heart attack, if you take aspirin to prevent heart disease and a specific COX2 inhibitor for arthritis like vioxx together you are really losing the benefit vioxx had over ibuprofen.

    Anyway not everyone has a sensitivity to asprin and Ibuprofen, there are estimate that only 8% of those prescribed Vioxx actually got a benefit over cheaper alternatives, but vioxx had a great ad campaign that convinced everybody that they should "ask" (read demand) their doctor to prescribe it, even though it is vastly more expensive. Also the FDA approval could be pushed through because of the "benefit" to those 8% of patients that had gastrointestinal sensitivity to aspirin and ibuprofen.

    So what have they found out now- well just inhibiting COX2 by itself actually causes increased blood platelet aggregation and increased risk of heart disease and stroke, this effect is balanced out by the inhibition of COX1 in aspirin and ibuprofen etc. that prevents platelet aggregation.

    Now the real issue, Vioxx was pushed out to compete with very cheap, safe and well charactised drugs (so we know all the side effects etc., why do you think you can buy them at the supermarket) due to a very long history of use. Patent it and get it approved for use by the FDA targeting it to one small specific group that have a problem with current treatments to help push the approval through. Once it is approved marketing it to a much wider group of people that are not the specific target group, and will not gain any benefit over a cheaper, better characterised and now known to be safer alternative. To compound the problem the TV advertising of prescription drugs now almost approaching saturation increases this problem by getting the public to demand drugs they don't need.

  16. Re:this is from brazil & france, NOT USA pharm by lukesl · · Score: 4, Insightful

    The reason this work is coming out of Brazil is the same reason the spinal cord story earlier this week came out of Korea. Namely, ethics. The single greatest hindrance to scientific advancement in the US. In the US, it would be unethical to conduct this study, because you couldn't let a group of people go without HIV meds for a year. That would be unethical. It's the same way it's unethical to test experimental therapies on patients with terminal cancer. Since their disease is terminal, it can be argued that they are consenting out of desperation, and the researcher is therefore taking advantage of them.

    In any case, dendritic cells were discovered in the US, HIV was discovered in the US, etc., so it can't be argued that the giant money machine of US science didn't contribute. It also can't be argued that the US does not lead the world in biomedical science. This is because we spend so much money on it that the best scientists from all over the world are concentrated here. However, I agree with you that this is not the same as the idiotic statement that we are subsidizing other nations' healthcare.

  17. "Could this be it?" NO. by cryptochrome · · Score: 5, Informative

    Like the parent said, it's a therapy, not a vaccine. It looks like it can help people who have been infected with HIV keep from developing AIDS, but it's not a cure and it won't prevent infection. Still, it's a welcome development.

    The fact is, HIV is the most daunting disease we have ever faced. If it had hit even 50 years earlier we may very well have faced an epidemic on the order of the Black Death. It infects and kills stealthily, and evolves within our bodies faster than our immune systems can recognize it. If it hadn't hit the gay community so severely and specifically we might not have even been able to identify it, and it's only thanks to advanced sequencing and crystallography technology that we can study it in the necessary depth. But what is really sobering is this: HIV has infected tens of millions of people, living and mutating within their bodies for decades, and as far as we know no one has ever fought off an infection. The human immune system may very well be completely unable to handle HIV, and that means we may never see a traditional vaccine.

    But we live in an age of rapid technological progress, and I do know of three promising possiblities that could actually prevent infection. None of them has yet been tested.

    The first is another line of french vaccine work. Sequence comparison between various strains of the virus had identified a highly conserved protein region on the GP41 surface protein. The antibodies produced against the peptide seems to target the virus extremely well in the lab. So why don't we see antibodies against this epitope in the real world? It turns out we sometimes do - but those people can still get sick. It may yet be useful but based on that simple fact I'm not holding my breath.

    The second hasn't even had an in vitro experiment yet and technically doens't prevent infection, but is a highly unusual and novel approach. Researchers at Berkeley have come up with the idea of a virus that is a parasite of HIV itself. The trick is that the antivirus cannot push the level of HIV too low, or the antivirus itself will die out and latent HIV will come back, which they were able to demonstrate thanks to computer simulations of the population dynamics. However, it can mute HIV activity and thus prevent infection from developing into full-blown AIDS. What's more, if the carrier happens to spread AIDS to someone else, the antivirus will go with it, and when HIV mutates the antivirus can still affect it. HIV would become a virus that people could live with without it killing them. But there is no way to know whether or not something unforseen can happen with what is essentially genetic engineering, and at the very least moving that research from the computer to the real world will be a real task. There is a lot of work to be done there.

    The third technology could be the real deal. The fact is, some lucky people are resistant to HIV infection. Their CCR5 receptors are knocked out, and apparently HIV is unable to fuse with the cells as a result. Genetically altering your immune system to suppress this gene might thus offer protection against AIDS. However, that same mutation may be associated with multiple sclerosis. Again, nothing like this has ever been tried.

    That's as far as I know, really. I regret that society and the government cynically ignored the epidemic when it was in far fewer people and might have been stopped with quarantine because it happened to affect a group that many people weren't fond of. I suspect now society may have to accept the inevitable and stop people from having multiple sexual partners. I fear the possiblity that HIV could mutate into something that can infect even without sexual contact in the meantime.

    --

    ---If you can't trust a nerd, who can you trust?