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In Europe, fish oil after heart attacks – but not here


Times reporter in Rome discovers amazing difference in treatment

Classic example of how US system defeats natural antidotes

Real solution is obvious – but far away

The seventh and eighth most searched keywords at the Times today were “health” and “science”, one ahead of “bush”. And we bet it is because of the article on taking fish oil after heart attacks, which is the second most emailed article.

What Elizabeth Rosenthal in Rome has found out will confirm the worst fears of those who suspect the drug companies and the FDA are somehow in cahoots against the welfare of Americans, refusing to give us what the Europeans in their more ancient wisdom hand out freely to their sick and diseased – in this case a key nutritional supplement which protects patients from dying after they have a heart attack.

Her article is polite and balanced in the Times manner so one has to read it closely to find out exactly what is going on. But it seems according to In Europe It’s Fish Oil After Heart Attacks, but Not in U.S. that the big Italian study ten years ago showed a sizeable indication that purified fish oil, or omega-3 fatty acids, can reduce deaths over three years by 20 per cent, and sudden deaths by forty per cent, if you dose heart attack patients within 24 hours after the event.

But there was a minor imperfection in the methodology – the study control group was untreated, rather than given a placebo – so the FDA will not accept the study’s impressive results, even though regulators in Spain, France, and Britain approved the prescription fish oil version, brand name Omacor, by 2004, and in Italy, according to the chief of cardiology at the Rome hospital Rosenthal quotes, every patient who survives a heart attack goes home with a prescription, and it is “considered tantamount to malpractice in Italy to omit the drug.”

Plenty of authoritative sources in the US support the practice too, Rosenthal finds, including a study in the Journal of the American Board of Family Medicine last month which said it was “important advice” to give patients.

But in the US patients are not given omega-3’s, nor are they offered information on it on the Omacor manufacturer’s Web site, which when it finds out you are a US citizen steers you past the information to a page where heart attacks are not mentioned! Instead, cardiologists and hospitals routinely offer more expensive and invasive treatments, in the form of pills and implanted defibrillators:

But in the United States, heart attack victims are not generally given omega-3 fatty acids, even as they are routinely offered more expensive and invasive treatments, like pills to lower cholesterol or implantable defibrillators. Prescription fish oil, sold under the brand name Omacor, is not even approved by the Food and Drug Administration for use in heart patients.

“Most cardiologists here are not giving omega-3’s even though the data supports it — there’s a real disconnect,” said Dr. Terry Jacobson, a preventive cardiologist at Emory University in Atlanta. “They have been very slow to incorporate the therapy.”

Whose fault is it?

So is this the fault of the drug companies, whose ads and salesmen steer the US medical fraternity to the drugs and tools they sell, and who in the absence of FDA approval for Omacor cannot even mention the European solution? Hardly. The lack of FDA approval means they can make no money out of it, without a hugely expensive clinical trial.

Because prescription fish oil is not licensed to prevent heart disease in the United States, drug companies may not legally promote it for that purpose at conferences, in doctors’ offices, to patients or even on the Internet.

“If people paid more attention to guidelines, more people would be on the drug,” Dr. Jacobson said. “But pharmaceutical companies can’t drive this change. The fact that it’s not licensed for this has definitely kept doctors away.”

For example, on Solvay Pharmaceutical’s Web site for Omacor, www.solvay-omacor.com, the first question a user sees is, “Are you a U.S. citizen?”

If the answer is yes, the user is sent to a page where heart attacks are not mentioned. (In the United States, Omacor is licensed only to treat the small number of people with extremely high blood triglyceride levels.)

So community doctors do not learn how to use the drug. Lack of F.D.A. approval also means that insurers will not pay for treatment with Omacor. Approval from the agency for the use of the drug in heart disease is not expected soon.

A study published last month in The Journal of the American Board of Family Medicine found that only 17 percent of family doctors were likely to prescribe fish oil to their patients, including patients who had suffered a heart attack. There was a great need, the authors concluded, to “improve awareness of this important advice.”

A lousy system, but why?

Clearly this is a lousy system in some respect or other. But what is the flaw? Maybe heart attack victims should rise up and storm the gates of the FDA and the NIH, and demand their rights. Why should they not be told about fish oil, have fish oil prescribed, see fish oil ads and read about them on the Web?

Come to think of it, why does this stuff need a precription anyway? Is pure fish oil a danger to your health in some way? The entire Mediterranean tradition says not. The Italians and the Greeks flourish on their delightful cuisine with minimal heart attacks, and as the article notes scientists have theorized as we all have that it’s the fish that do it, along with the wine.

And why does it have to be pure? According to Rosenthal,

over-the-counter preparations of fish oil have much less rigorous quality control and are often blends of the two fish oils know to be beneficial in heart disease with other less useful fatty acids.

For that reason, Dr. Jacobson of Emory gives the prescription drug, “off label,” to cardiac patients, even though the F.D.A. has not approved it for that use. “Then I know exactly what they’re getting, and there is no mercury,” he said.

So according to this the dangers of non-precription versions are “less useful fatty acids” and “mercury”. Is that a reason not to have generic fish oil available?

Still, hard to see why the company with the license for the drug in the US doesn’t seem in a hurry to go through the necessary trials in the US and market Omacor here. Could it be the cost of such trials, which involve hundreds of millions of dollars?

Marylou Rowe, a spokeswoman for Reliant Pharmaceuticals, which owns the license for the drug in the United States, said that further trials of Omacor would be needed for it to be licensed for heart attack patients in the United States. But she refused to discuss a timetable.

Why is is “ethical” to withhold fish oil and not HAART?

The whole story is a classic study of what is wrong with the health delivery system in the US. The FDA is placing a giant hurdle for an obviously beneficial natural compound to jump over before it can be part of the system, and while it is kept from being prescribed all the experts salute its benefit and even pop omega-3 pills themselves.

Rather embarrassing parallels can be seen in the world of HIV∫AIDS where it is becoming rather evident that what the top scientists know and talk about quietly among themselves is a lot more enlightened than what they release for public consumption.

For example, the aforementioned JAMA study below breaking the link between the virus and immune cell depletion which is now causing a little debate in Science and elsewhere, where the authors of the study plainly say it knocks out a basic assumption of the paradigm, but are careful to state their faith in the paradigm itself at every public opportunity to avoid getting in Dutch with Dr Fauci.

We have a friend who recently had a heart attack and was carted off to hospital for a triple by pass. Apparently we now have the duty of briefing him on the need to ask his cardiologist about omega-3 fatty acids when we see him next. Evidently the system cannot now be trusted in this simple matter.

As for the methodological weakness of the massive Italian study which brought the good news in the first place, is this really important enough for the FDA to hesitate before giving permission to cardiologists to prescribe them if they wish?

the landmark Gissi-Prevenzione trial of fish oil had methodological weaknesses: the patients treated with prescription fish oil pills were compared with untreated patients, rather than with patients given a dummy pill. This meant that, despite impressive results, the trial did not meet the F.D.A.’s standards for approval. Yet by 2004, regulators in almost all European countries, including Spain, France and Britain, had approved Omacor for use in heart attack patients.

Obviously not.

After all, if the FDA officials can see their way to forgiving the need for placebo groups in trials of the most dangerous HIV∫AIDS drugs, why is it so hard for them to forgive a slight methodological weakness in a huge trial of a familiar natural substance that the entire world agrees is good for you and rule that it would be “unethical” to withhold it from Americans after heart attacks?

The real solution is far, far away

The story highlights the basic problem with the current profit based system, where “the fundamental premise of US health care is that patients suffer from a deficiency in drugs,” as Robert Houston has wittily observed.

What is needed is for the government to finance nutritional and other approaches to combating ill health which cannot be patented and/or cannot ever be profitable enough to justify the hundreds of millions of dollars needed to finance clinical trials to win approval from the FDA (up to $900 million according to a Tufts University study).

But of course in their extreme capitalist frenzy it is unlikely that our present rulers or their party will ever recognize the fact that economics has a welfare dimension which cannot be reliably covered by the activities of profit making companies, unless government takes action in some way to provide incentives.

So for the moment we will just have to hope that the senior guilt trips of robber barons and other highly successful entrepreneurs and investors such as Bill Gates and Warren Buffett will include the idea of funding unprofitable avenues of research into alternatives to profitable drugs.

What we are saying is simple: someone should call or phone Bill Gates, Bill or Hilary Clinton, or any other parties of influence and get either government officials or rich men to fund the trials of natural alternatives so that the FDA has more to license than the latest profit making synthetic drug to come down the pipeline after trials which in HIV∫AIDS at least are notoriously corrupt and which novel chemicals are generally unpredictable in terms of side effects when mixed with numbers of other commercial drugs given the patients, as is so often the case with seniors.

In a sane system it may be that the NIH should be spending $3 billion a year on such trials, starting, for example, with selenium and its relevancy to the health of the immune system.

Under the current system the products of mother nature are effectively banned in favor of synthetic drugs, because they cannot be patented so if any company pays for expensive trials it cannot be sure of payback, since companies with competing versions will be free to come in and exploit the market without any upfront cost.

What’s even more egregious is the kind of thing that happened with AZT where the government paid for invention of the drug and the trials and then handed over the patent to Burroughs Wellcome who proceeded to jack up the price and make money killing people with high doses of this DNA chain terminator branded as Retrovir.

(In Europe It’s Fish Oil After Heart Attacks, but Not in U.S. by Elizabeth Rosenthal:

(show)

October 3, 2006

In Europe It’s Fish Oil After Heart Attacks, but Not in U.S.

By ELISABETH ROSENTHAL

ROME — Every patient in the cardiac care unit at the San Filippo Neri Hospital who survives a heart attack goes home with a prescription for purified fish oil, or omega-3 fatty acids.

“It is clearly recommended in international guidelines,” said Dr. Massimo Santini, the hospital’s chief of cardiology, who added that it would be considered tantamount to malpractice in Italy to omit the drug.

In a large number of studies, prescription fish oil has been shown to improve survival after heart attacks and to reduce fatal heart rhythms. The American College of Cardiology recently strengthened its position on the medical benefit of fish oil, although some critics say that studies have not defined the magnitude of the effect.

But in the United States, heart attack victims are not generally given omega-3 fatty acids, even as they are routinely offered more expensive and invasive treatments, like pills to lower cholesterol or implantable defibrillators. Prescription fish oil, sold under the brand name Omacor, is not even approved by the Food and Drug Administration for use in heart patients.

“Most cardiologists here are not giving omega-3’s even though the data supports it — there’s a real disconnect,” said Dr. Terry Jacobson, a preventive cardiologist at Emory University in Atlanta. “They have been very slow to incorporate the therapy.”

The fact that heart patients receive such different treatments in sophisticated hospitals around the world highlights the central role that drug companies play in disseminating medical information, experts said.

Because prescription fish oil is not licensed to prevent heart disease in the United States, drug companies may not legally promote it for that purpose at conferences, in doctors’ offices, to patients or even on the Internet.

“If people paid more attention to guidelines, more people would be on the drug,” Dr. Jacobson said. “But pharmaceutical companies can’t drive this change. The fact that it’s not licensed for this has definitely kept doctors away.”

For example, on Solvay Pharmaceutical’s Web site for Omacor, www.solvay-omacor.com, the first question a user sees is, “Are you a U.S. citizen?”

If the answer is yes, the user is sent to a page where heart attacks are not mentioned. (In the United States, Omacor is licensed only to treat the small number of people with extremely high blood triglyceride levels.)

So community doctors do not learn how to use the drug. Lack of F.D.A. approval also means that insurers will not pay for treatment with Omacor. Approval from the agency for the use of the drug in heart disease is not expected soon.

A study published last month in The Journal of the American Board of Family Medicine found that only 17 percent of family doctors were likely to prescribe fish oil to their patients, including patients who had suffered a heart attack. There was a great need, the authors concluded, to “improve awareness of this important advice.”

The fact that fish oil is also sold as a nutritional supplement has made it harder for some doctors to regard it as a powerful drug, experts said.

“Using this medicine is very popular here in Italy, I think partly because so many cardiologists in this country participated in the studies and were aware of the results,” said Dr. Maria Franzosi, a researcher at the Mario Negri Institute in Milan. “In other countries, uptake may be harder because doctors think of it as just a dietary intervention.”

In the largest study of fish oil — conducted more than a decade ago — Italian researchers from the Gissi Group (Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto), gave 11,000 patients one gram of prescription fish oil a day after heart attacks. After three years, the study found that the number of deaths was reduced by 20 percent and that the number of sudden deaths by 40 percent, compared with a control group.

Later studies have continued to yield positive results, although some scientists say there are still gaps in knowledge.

This summer, a critical review of existing research in BMJ, The British Medical Journal, “cast doubt over the size of the effect of these medications” for the general population, said Dr. Roger Harrison, an author of the paper, “but still suggested that they might benefit some people as a treatment.”

Dr. Harrison said he believed that people should generally increase their intake of omega-3 acids, best done by eating more fish.

Still, he acknowledged that it was difficult to eat foods containing a gram of omega-3 acids each day. “If you ask me do I take omega-3 supplements every day, then, embarrassingly, the answer is yes,” said Dr. Harrison, a professor at Bolton Primary Care Trust of the University of Manchester in England.

“I, too, am caught up in this hectic world where I have little time to shop and prepare the healthy foods I know I should be eating,” he said.

It seems natural for Italy to be at the forefront of the fish oil trend and home to the largest clinical trials. Scientists have long noted that Mediterranean diets are salubrious for the heart and theorized that the high content of broiled and baked fish might be partly responsible.

But the landmark Gissi-Prevenzione trial of fish oil had methodological weaknesses: the patients treated with prescription fish oil pills were compared with untreated patients, rather than with patients given a dummy pill. This meant that, despite impressive results, the trial did not meet the F.D.A.’s standards for approval. Yet by 2004, regulators in almost all European countries, including Spain, France and Britain, had approved Omacor for use in heart attack patients.

Marylou Rowe, a spokeswoman for Reliant Pharmaceuticals, which owns the license for the drug in the United States, said that further trials of Omacor would be needed for it to be licensed for heart attack patients in the United States. But she refused to discuss a timetable.

The American College of Cardiology now advises patients with coronary artery disease to increase their consumption of omega-3 acids to one gram a day, but it does not specify if this should be achieved by eating fish or by taking capsules. But over-the-counter preparations of fish oil have much less rigorous quality control and are often blends of the two fish oils know to be beneficial in heart disease with other less useful fatty acids.

For that reason, Dr. Jacobson of Emory gives the prescription drug, “off label,” to cardiac patients, even though the F.D.A. has not approved it for that use. “Then I know exactly what they’re getting, and there is no mercury,” he said.

He said he tells patients who cannot afford the prescription version that they can take the over-the-counter supplements, although there is uncertainty about the dose and they probably need three to four pills a day.

In Europe, meanwhile, research on prescription fish oil, which is now thought to act by stabilizing cell membranes, has gained momentum. The Gissi Group is conducting two huge trials using fish oil in patients with abnormal heart rhythms and in patients with heart failure.

165 Responses to “In Europe, fish oil after heart attacks – but not here”

  1. trrll Says:

    Trrll, let me suggest this paper, “J Brosius and SJ Gould, On Genomenclature”: A Comprehensive (and Respectful) Taxonomy for Pseudogenes and Other “Junk DNA”, Proceedings of the National Academy of Sciences, Vol 89, 10706-10710; 1992” Note junk is in quotes.

    I’m surprised that you would cite this. Not only do the authors not define the term “junk genes,” but they are even arguing against the use of the term “junk DNA,” (which in contrast to the oxymoron ‘junk DNA’ actually does have a recognized scientific meaning).

    A clinician’c reviews of the pile of anecdotes can indeed lead to rational assessments of biological plausibility and strength of the association.

    “The plural of ‘anecdote’ is not ‘data’.” At best, anecdotes may offer the basis for a hypothesis that can then be tested using rigorous statistical methods.

    They explain the result, gp120 NOT in purified “virions”. Sentence fragments due to your apparent literacy problem.

    Not exactly. They say, “Initial purification studies using sucrose-banded virions showed that very little gp120 was present. The levels observed were 0.06-0.10 ug/mg of virus protein. ” Thus, it was clearly present. By the way, to a scientist, “Not significantly present” does not equate to “absent.” Rather, “not significantly present,” means “the sensitivity and reproducibility of my assay is not sufficient for me to assert at better than 95% certainty that I have detected this protein.” Always remember the scientific adage, “absence of evidence is not evidence of absence.” This is particularly the case when it comes to immunolabeling and immunopurification. Antibodies are notoriously quirky, and false negatives are common, so scientists rarely try to make too much out of a negative result unless it is supported by a very strong set of control experiments to demonstrate that they would have detected the protein if it were present. Furthermore, gp120 is not an integral membrane protein. That means that it is relatively loosely attached to the viral particle, and could potentially fall off during a purification procedure–another reason not to overinterpret a negative result.

    Moreover, a few minutes of searching on MedLine or Google would have shown you that many labs have been successful in finding gp120 in purified virions–See, e.g. Moore et al. (1990) Science 250:1139. So your obsessing about this one paper is an example of one of the defining features of “denialists”:

    Selectivity Denialists will often cite: a critical paper supporting their idea, or famously discredited or flawed papers meant to make the field look like a it’s based on weak research.

    Thanks for trying, do you care to play again? Remember, the challenge was to provide a rational argument as to why gp120 should be more abundant in virus particles than in infected cells.

  2. objukwu Says:

    No, I can’t, Chris…I can’t *answer* or *explain* it , because I don’t know. I can’t *explain how *syphyllis manages to …to achieve a higher male-to-female ratio than HIV, not because because I don’t *want* to answer(…none of the experts here appear to *want* to answer…), it’s because I don’t KNOW the answer. I don’t know the answer to that any more than I know the answer to why Donna Shalala predicted that 100,000,000 would have HIV by the year 2000. If it’s not because men are so much more likely to work oppressive 20 hr shifts near all that toxic, sweltering blast furnace heat in high voltage scrap metal plants trying to recover copper and lead and As2O3 unless they are homosexual and on a different continent, then what is the answer? Is it because they inject too much mercury? Is it the arsenates?Tell us the answer, Chris.
    What are you waiting for, Halloween? It’s here already. So you can cut loose with the answer. Unless what , everybody has to cave at once? Then you get an extra bonus in your check? (Does it come at the end of the month , or the end of the quarter?) Tell us, because we need to know why the ratio is different and this is starting to get on my nerves.

  3. objukwu Says:

    Hell, I don’t know why I didn’t think of this sooner…..Pssst, Hey TRlll, why don’t you tell us the damn answer. Why is the ratio different trlll? Is it because of arsenate, or because homosexuals inject too much mercury? , Do you have a drivers licence? Chris says you’re only one meter tall, Trlll. Did you know that president Kennedy was assasinated? Trlll , if I’m speelling your name wrong , pleases let me know, i don’t mean any disrespect. I know that Isaac Newton took too much mercury, Trlll, but I don’t know if he had syphillis, although the odds(according to Chris) would favour it. Do you want me to fix you up with Donna shalala, Trlll? You never did get back to me on that. Why, Trlll. Are you shy?Did the kids taunt you when you were in school? Donna never pays her parking tickets Trlll. She says that 100,000,000 Americans would have HIV by the year 2000. Thhis was a very dire prediction she made on the floor of the US congress when they were trying to fix social security. Donna told the leaders of democracy and the free world there was no need to worry about getting the social pension budget in balance ,— or what ever you call it,—-that it was a complete waste of time and effort, because all you had to do was run the numbers to see that by the time retirement came around for these people , everybody would be dead. Which i din’t completely understand, but , hell, I’m not really that good with math. And I was wrong earlier when I said they had to have driver’s licences – I meant social security cards. But Donna is now the head football coach of the Miami Hurricanes , and all of the players on her squad are criminals on probation. One of their players, Trlll, killed his cousin in an argument over a sandwich at a family barbecue(State of Florida v Benny Blades), but he got off. It scares the other team, trlll , when they think somebody is going to shoot them if they get to far ahead, so you have to figure that into the point spread.
    Something else , Trlll, I should tell you before the date : Donna is connected. Don’t let the name Shalalala fool you. Her real name is Tedesco. She changed it in college , after a proffessor who gave her a bad grade disappeared mysteriously and was never heard from again . I know Isaac Newton took too much mercury,Trlll, but I don’t know if he had syphillis or not, even though of the higher probability. Trlll,did you pay back your student loan? How big is your medical bag. If you are only one meter tall, does it have luggage wheels on one end to make it easier to handle? Chris told us how you are only one meter tall but he won’t give us any other details except you grew up right next to a methylene chloride plant. He won’t tell us anything about what you look like. Trlll, did you know that Chris tried to hypnotize his cat? And then , when his wife started nagging him again about cutting the grass, he told her he was going to jump into the sky in a single bound and fly away to another world. He told her he was going to form an alliance with other people who also had super powers if she didn’t get off his back. Do you have specially made shoes trlll? DID you pay back your student loan Trlll(we’re not going to let that one slide)? You use the word *sane* a lot, in various froms, like no *sane* biologist, no scientists in *his right mind*, no doctor *with all his marble* would ever think of injecting mercury into a homosexual…I was wondering, why that is, Trlll? Sanity seems to be a big deal to you(whilst I pay it no mind whatsoever). Trlll, do kids make fun of you when you go to the park? Does your family let you eat at the table? When you were at University, did some guys from your fraternity often trick you into going out with them to a bar, and then they would all get drunk and start tossing you from table to table like a soccer ball? Do you have specially made shoes? Tell us the answer to Chris’s question about the ratio , Trlll, and I’ll tell what happened when I debated Chris at a public forum in Sydney. Trlll, did you know that the Battle of Gettysburg in the American Civil War started from a fight over some shoes? I don’t know why president Kennedy was assasinated ,trlll gut I doubt if it was because of mercury or syphillis,. Unless you know something different, Trlll, tell us your opinion. We’re interested in you.

  4. MacDonald Says:

    Trrll, are you really as short as Objukwu has told Chris?
    Personally I don’trust short people as far as I can throw them (forgive me if I invoke unpleasant memories from your school days), but there’s a lot of short people in high places telling tall stories and being very important, so don’t let it get you down. It’s highly unscientific anyway.

    But Objukwu hasn’t exhausted al the questions by far. . .

    I see you’ve CHALLENGED us all, me, Lise, Gene Semon, ALL of us. “THE challenge was to provide a rational argument why gp120 should be more abundant in virus particles than in infected cells.”

    Trrll, why do you get to decide what THE challenge is? Is it something to do with your physical appearance? Have you thought about using it to your chosen party’s advantage in political ads? BIG money. Why should virions purified or not have any gp120 at all? Would it falsify anything? Would it make a difference to human growth? Why does Robin Weiss say it’s easy to purify knobless virions in sucrose density etc. Why would he say something like that? Is it a part of THE challenge? Is infection not isolation? What IS the challenge all about, and is there a prize for the winner?

  5. Gene Semon Says:

    Good, trrll, excellent responses. You’re completely in synch with the current re-branding campaign that’s all over the place in media.

    Are you now Dale, by any chance? You want to play? Why not drop the anonymous bit?

    Afraid of embarrassing yourself on the www?

    More of that damned, heretical denialist propaganda: biological plausibility. Notwithstanding your huffing and puffing over gp120, you’ve evaded this substantive point.

    What the data tells us is that natural selection in vivo produces 99.99% defective HIVs. The next problem ultimate destroyer HI Vendetta – (since you’ve endowed it with purpose) – faces is in the proviral stage, and here we assume an individual arrives with its GENES (= RNA/DNA coding regions) intact so it actually is a self respecting organism. It is dead-on-arrival in the chromosome, a well recognized phenomenon in retronuons known as transcriptional silencing. It is, like its endogenous counterparts, now subject to the transcriptional apparatus of the cell and incapable of “co-opting” the cellular machinery.

    Now, what you willfully ignore from the previous posts re the LTR: subgenomic transcription in retroviruses means oxidant-induced RNA transcripts, gag-pol and env, are observed in association with reverse transcriptase production in cell lines. In vivo, this phenomenon is observed when a branched DNA assay is deployed to measure the pol RNA, an EFFECT of the toxic overload => pro-oxidant stress, that does not equate to the measurement of purified, non-defective virions. Particle association is “assumed”.

    The fun starts when an experimentalist or outside observer overstates these results as “isolation” of a previously unknown organism.

    “The plural of ‘anecdote’ is not ‘data’.” At best, anecdotes may offer the basis for a hypothesis that can then be tested using rigorous statistical methods.

    You really believe this? A clinician’s results MUST be massaged by statistical methods in order to count for anything. Let’s follow this logic. We treat 100 patients with full-blown AIDS using a combination of non-pharmaceutical remedies derived from Drs. Rath, Giraldo, Null and Ali. I’m going to get a little crazy here, but say 99 have their AIDS-defining diseases reversed and this is confirmed by yearly follow-ups. Note that hypothesis testing is inherent in the protocol, the details are published and results replicated by other clinicians. No conclusions permitted, eh trrll?

    Moreover, a few minutes of searching on MedLine or Google would have shown you that many labs have been successful in finding gp120 in purified virions.

    Does your reference show us an EM of these “purified virions” from the sucrose density band?

    The point of your challenge SHOULD be, how many NONDEFECTIVE virions, i.e., capable of “the complete life cycle” of the putative uniquely unique Houdini IV – from provirus to provirus in the next cell – exist in vivo, based on the indirect ex vivo and in vitro measurements. Considering all the arguments of Perth and Duesberg, your selective challenge collapses as pointless. SELECTIVITY is inherent in the making of a rational argument, is it not, trrll? Selectivities also add up, but you’re very good at playing “constructive dismissal” or “whacking the mole” – to use Chris’ expression; so you willfully ignore other papers (e.g. Piatak et al – again Harvey’s book), posts, etc on the matter at hand to come up with the most interesting charge of “obsessing”.

    After all this, still nothing from you to support the proposed genus HIV as causing anything.

  6. Gene Semon Says:

    More Than a Hypothetical

    From http://www.virusmyth.net/aids/data/gnhivequals.htm

    Gary Null: “The resistance to new evidence and exploration continues. Just last year, (1994) I sponsored a conference featuring 100 AIDS survivors who beat the odds using alternative therapies. Although press releases were issued on three occasions, not a single member of the mainstream media attended.”

    VNR based “news”, memory holes and rebranding campaigns: all reflect the disappearance of mainstream investigative journalism and the “propaganda model”.

  7. trrll Says:

    What the data tells us is that natural selection in vivo produces 99.99% defective HIVs.

    So what? Let’s think about it from the perspective of natural selection. What is the cost to the virus of the production of defective virions? Answer: virtually nil. After all, it is using the host cell’s resources, so it can afford to be wasteful and inefficient. Keep in mind also that HIV is still relatively new to the human host, so it would not be surprising if efficiency of assembly is poor. The shortest “mutational path” to compensating for poor efficiency is overproduction. So the valid question is not what percentage of defective virions are formed, but rather whether there are enough complete ones (even if the percentage is low) such that new cells are infected faster than host cells die off.

    You really believe this? A clinician’s results MUST be massaged by statistical methods in order to count for anything. Let’s follow this logic. We treat 100 patients with full-blown AIDS using a combination of non-pharmaceutical remedies derived from Drs. Rath, Giraldo, Null and Ali. I’m going to get a little crazy here, but say 99 have their AIDS-defining diseases reversed and this is confirmed by yearly follow-ups. Note that hypothesis testing is inherent in the protocol, the details are published and results replicated by other clinicians. No conclusions permitted, eh trrll?

    Statistics do not “massage” data; rather, they test for validity and assess the impact of possible biases and chance fluctuations. So if you treat 100 patients, with an appropriate control group, and analyze the results with valid statistics, you have moved beyond anecdote into the realm of science.

    The next problem ultimate destroyer HI Vendetta – (since you’ve endowed it with purpose) – faces is in the proviral stage, and here we assume an individual arrives with its GENES (= RNA/DNA coding regions) intact so it actually is a self respecting organism. It is dead-on-arrival in the chromosome, a well recognized phenomenon in retronuons known as transcriptional silencing. It is, like its endogenous counterparts, now subject to the transcriptional apparatus of the cell and incapable of “co-opting” the cellular machinery.

    The virus brings along its own promoters, which enable it to subvert the cell’s mechanisms of transcriptional regulation. Cellular mechanisms of transcriptional silencing of retroviral DNA are not infallible, and of course there is strong selective pressure for the virus to circumvent cellular mechanisms of recognizing and silencing viral insertions.

    The point of your challenge SHOULD be, how many NONDEFECTIVE virions, i.e., capable of “the complete life cycle” of the putative uniquely unique Houdini IV – from provirus to provirus in the next cell – exist in vivo, based on the indirect ex vivo and in vitro measurements.

    More accurately, it is whether there are sufficient infective virions to propagate the virus, irrespective of how much excess there is in the form of shed proteins and incomplete virions. Considering that a single virus particle is in principle capable of infecting a cell, they could be very much in the minority and yet the infection would continue.

  8. trrll Says:

    I see you’ve CHALLENGED us all, me, Lise, Gene Semon, ALL of us. “THE challenge was to provide a rational argument why gp120 should be more abundant in virus particles than in infected cells.”

    Trrll, why do you get to decide what THE challenge is?

    I guess I can take this as admission that you have been unable to come up with any kind of rational argument to support that proposition.

    It is not my decision or choice, it is those inflexible, fascistic rules of logic and evidence that set the challenges that all scientists must face–that dictate, for example, that if you wish to offer a particular observation as evidence for theory A over theory B, you actually need to demonstrate logically that theory A predicts that result and that theory B does not, and you also need to show that the observations are valid. You are not allowed to use cheats such as taking “no significant amount of gp120” as equivalent to “gp120 is absent,” or citing the papers that fail to detect gp120 and ignoring the ones that succeed.

    So if you want to argue that lower levels of gp120 in purified virions than in infected cells constitute evidence against the HIV theory of AIDS, you need to show that the HIV theory predicts higher levels in purified virions in cells, and also that gp120 would necessarily be expected to copurify with the virus, and not be lost in the purification process.

  9. MacDonald Says:

    I guess I can take this as admission that you have been unable to come up with any kind of rational argument to support that proposition.

    Absolutely. None whatsoever, you clever devil! (‘small but smart’ as they say where I come from – never mind exactly where)

    So the valid question is not what percentage of defective virions are formed, but rather whether there are enough complete ones (even if the percentage is low) such that new cells are infected faster than host cells die off.

    I guess I can take this as admission that you’re fonder of anecdotes than you let on.

  10. Chris Noble Says:

    What the data tells us is that natural selection in vivo produces 99.99% defective HIVs.

    Other viruses like FMDV have high mutation rates that put them close to the error catastrophe.

    There is obviously a trade off between the benefits of a high mutation rate that allows for rapid evolution and the high proportion of defective virions.

    Several viruses including HIV operate at close to the error catastrophe. There is nothing strange about this.

  11. Gene Semon Says:

    I guess this is the Dale/trrll machine; a semblance of reasonableness, definitely appreciated.

    IMHO, this “agency” attributed to Houdini who may kill or not kill is a form of teleology, not modern science. Terms like “cost/benefit” are descriptive, and beg for a physiological handle. What environment is doing the “purifying selection” that overcomes the entropic degeneration of the retro-informational sets of cellular signals. And what is the function of the emergency information transfer that makes it through the “error catastrophe”?

    Here’s another way of stating the problem:

    “To help you understand the mind set of the human genomics community, these regulatory genes are commonly referred to in the literature as “junk genes.” The name junk implies that not much is known about these elements. But in fact, the lexicon of regulatory genes is quite rich and includes things like: long interspersed elements, short interspersed elements, endogenous retroviruses, transposons, retrotransposons, Alu retroelements, short interfering RNAs, micro RNAs, snos, and microsatellites, to name a few. The study of the relationships between gene control and biological function is referred to as “regulatory genomics.” Confused? We are talking about the human body. Many of us believe the beauty of life comes from its complexity.

    “The AIDS research community has completely ignored the field of regulatory genomics. In a letter to the Department of Health and Human Services (DHHS) last year, I suggested that their position that HIV is the sole cause of AIDS is substantially based on scientists studying complex mixtures of biological fluids with unknown numbers of regulatory genes and concluding that one big structural gene, HIV, is causing the syndrome. This is medical incompetence at its worst.” (REPLY TO THE PERTH GROUP BY HOWARD URNOVITZ, July 22, 2002, http://www.redflagsweekly.com/debate/2002_july22.html)

  12. Chris Noble Says:

    IMHO, this “agency” attributed to Houdini who may kill or not kill is a form of teleology, not modern science. Terms like “cost/benefit” are descriptive, and beg for a physiological handle. What environment is doing the “purifying selection” that overcomes the entropic degeneration of the retro-informational sets of cellular signals. And what is the function of the emergency information transfer that makes it through the “error catastrophe”?

    I’ve finally worked it out. I’ve been responding to a computer program.

    http://dev.null.org/dadaengine/

    Somebody has taken a glossary from a molecular biology text book and used it in an application using the Dada engine.

    For an example of text created by the Dada engine see this

    http://www.elsewhere.org/pomo

  13. Gene Semon Says:

    Very good. Excellent response. I’ve been looking for an application of the appropriate AI program to deal with you guys. You mean a Bull-Dada engine?

    In the meantime, more programming to respond to. Let’s consider the following:

    “Other viruses like FMDV have high mutation rates that put them close to the error catastrophe.

    ”There is obviously a trade off between the benefits of a high mutation rate that allows for rapid evolution and the high proportion of defective virions.

    ”Several viruses including HIV operate at close to the error catastrophe. There is nothing strange about this.”

    Now, Chris, do you really know what you’re talking about here? Remember, you don’t want to lose to a computer.

    I notice nothing regarding the “rescue” from error catastrophe by retroviral recombination or that “various gene products are changing at different rates”. I.e. why is the 4kb gag-pol segment coding for reverse transcriptase, ribonuclease H, endonuclease and proteases “more refractory to both recombination and residue substitution than either the envelope or the terminal gag regions”?

    And what about pseudotyping? As in, “A member of the HERV-W family of human endogenous retroviruses (HERV) had previously been demonstrated to encode a functional envelope which can form pseudotypes with human immunodeficiency virus type 1 virions and confer infectivity on the resulting retrovirus particles.” Blaise et al, Journal of Virology, January 2004, p. 1050-1054, Vol. 78, No. 2)

    Does “Shannon entropy” have anything to do with this and can it be quantitated in picornaviruses?

    Finally, I’m sure you can provide a good account based on current research of extant – some even newly discovered, e.g. iRNA – cellular inhibitors that cause “lethal mutagenesis” to our Mr. Houdini I. Vendetta.

    A hacker of those two sites has informed me that something like a “graft” of lymphocytes, generously donated to certain “bottoms” as recipients or gracious “hosts”, may even explain the transcription phenomena associated with the “infectious transmissions” that we are honing onto thru a semblance of a rational dialogue right here at NAR.

    Once again, I’m really rooting for you Chris and confident that you will display the depth of your understanding to the “grand master” on the other side.

  14. trrll Says:

    Here’s another way of stating the problem:

    “To help you understand the mind set of the human genomics community, these regulatory genes are commonly referred to in the literature as “junk genes.”

    This tells me more about the mindset of the person who wrote it, because in fact (as I mentioned previously) in a MedLine search, the expression “junk genes” turns up not even once . So this supposedly “common” expression does not turn up even once in the abstract, title, or keywords of any of the 14 million references in the literature.

    The author goes on to write “The name junk implies that not much is known about these elements”. Now this is just idiotic. I thought at first that he was just confused and talking about the somewhat slangy expression “junk DNA,” which does have a scientific meaning although even it does not qualify as “commonly” used (75 references in Medline). But “junk DNA” specifically refers to sequences with no function at all–regulatory elements, whether imperfectly understood or not, do not qualify. And of course, “junk genes” is an oxymoron, because a gene by definition codes for something, which is a function, and therefore it cannot qualify as “junk.”

    So what’s with this guy? Is he just making it up, and outright lying about the expression being common in the literature? Or did he misunderstand something he overheard somewhere, and is just too dumb or lazy to do a Medline search?

  15. Nick Naylor Says:

    Terrell said (10/06): “Alternative medicine has yet to prove itself by rigorous scientific standards as a source of medical treatments with efficacy comparable to conventional therapies.”

    A blast from the past to remind us how they never stop reciting from the same catechism, no matter how much evidence is presented.

    “Rigorous scientific standards” means double-blind placebo controlled studies. These may be appropriate for pharma drugs but one has to wonder why they are elevated to an immutable and eternal law when considering “alternative medicine.”

    Later (right above) our hero attacks Howard Urnovitz for using a common term “junk genes” instead of the more precise junk DNA and really gets all worked up over this great affront to rigor.

    Wow, Terrell really showed his stuff here. Of course, if he ever actually debated Dr. Urnovitz on the dynamic genome, we’d have to rename him Pancake Trrll.

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