Re: new vapor virus

May 23, 2006

Vapor Virus? Questioning the Science Behind Hepatitis C By Regush Hepatitis C is said to be a silent blood-borne epidemic that affects many millions who are unaware that they are ill. But do these people really have this virus?

Consider this a challenge in progress. This scientific adventure raises the question of whether the hepatitis C virus, blamed for a major silent epidemic of liver disease and even cancer, actually exists. That’s right. You read this correctly: I am raising a question that may disturb scientists and hepatitis C patients alike. But I’m raising it anyway because it is vital to do so in the interests of public health. I’m issuing a challenge to the scientific community to present me with the published, peer-reviewed scientific evidence that such a virus actually exists— namely that it has been properly isolated, according to accepted, fundamental

principles of virology. (Note: No one took Regush, chief science writer for ABC news for 30 years, up on his challenge from 1998 until his death in 2005) Thus far, I should tell you, I’m underwhelmed by the evidence for the existence of such a virus. Before tackling this issue bluntly and in far more detail next week, I’ve decided to offer those who believe the science supporting the virus is adequate the opportunity to educate me on the subject. (We’ll even run your letters.) You can do this by providing me with key references for proof that hepatitis C virus is real and not some meaningless biotech concoction posing as a real virus. I plan to ignore any speculative theories, pole-vaults in reaching conclusions and the usual harangues from the medical and scientific community about the stupidity and irresponsibility of journalists. I have little patience for emotional approaches to this important scientific issue. Many months ago, I wrote a column about hepatitis C, arguing that government officials botched proper testing of the blood supply for the virus. (A number of lawsuits are in progress, claiming the government was negligent.) In other words, I had automatically accepted the conventional wisdom that such a virus exists.

I’m not blaming myself here; there is only so much research that one can do at any time, and we are often condemned, as I’m sure you will agree, to rely heavily on the views of others, particularly when there appears to be strong scientific consensus. Inquiring Readers Want to Know In response to that column, I have received a regular flurry of e-mail from readers who ask me to write more about hepatitis C, particularly about how this epidemic has been neglected by the government and

medical community. So, in response to these letters, and out of genuine curiosity, I have been slowly, but systematically, exploring the scientific literature. What I discovered surprised me. But first, let’s look at the conventional wisdom on hepatitis C: Official estimates are that about 4 million Americans have been infected by the virus, that many don’t know they’re infected, and that some of these people (it’s not clear how many) who now have no symptoms, will go on, perhaps in 20 or 30 years, to develop a scarring of their liver known as cirrhosis, which, in some cases, will lead to liver cancer. Unknown Origins The conventional wisdom says that this is a virus spread through direct contact with contaminated blood; that means through such routes as sex, sharing needles for drug use and, of course, blood transfusions, particularly in the ’60s, ’70s and ’80s, before the blood supply was appropriately monitored. For many of the people, perhaps as many as half who have positive hepatitis-C antibody tests, the manner in which they may have contracted the virus remains a mystery. Antiviral drugs, often in combination, are the main fighting force against hepatitis C, though, again according to the conventional wisdom, they appear to be only modestly effective in about half of patients and have serious side effects. When scanning the literature, most of this type of information pops up again and again. And media reports on the science do not question the conventional wisdom, at least not the numerous ones I’ve perused. Yet, the more I read the science, the more troubling it appears, as I will reveal in some detail next week. Challenge of the Week As regular readers of this column know, I have taken it upon myself to call some of the conventional wisdom in medicine into question if adequate science has been bypassed in favor of speculation, hype and/or commercial gain. What has especially energized me, of late, is the debate I still hope to have with Dr. Rodrigo Munoz, president of the American Psychiatric Association, over the science underlying the prescription of antidepressant drugs. Unfortunately, it looks as though Munoz

is shying away from a public encounter with me, even after suggesting to me in an e-mail that he might be willing to take a crack at it. Oh, well, maybe a prominent hepatitis C expert, perhaps even someone involved in the discovery of hepatitis C, will want to have a free-ranging public debate on what it means to isolate a virus. ABCNEWS.com Fishing for Viruses: Even Good Researchers Sometimes Use Wrong Bait By Regush No one's been able to come up with a hepatitis C virus, purify it, inject it into an animal and cause hepatitis. Let me lay it on the line for you: I have never once thought — or written — that

hepatitis C is a psychological problem. I have no doubt whatsoever that people have developed liver scarring and that many have developed liver disease and died from it. But after 30 years of reporting on science, I can sometimes smell a skunk. This time, the skunk is a so-called virus called hepatitis C virus (HCV), which is blamed for much of the severe liver disease people suffer. I certainly feel compassion for people who become ill with liver disease. But I have less than nice feelings for scientific enterprise that is shallow and takes red-flag shortcuts, which is exactly what I have concluded has occurred with the science underlying the claim that a hepatitis C virus has been properly identified.

Flawed Fundamentals? When you get beyond all the biotech smoke and mirrors — and you need to take time to travel through this fantasyland to appreciate the nuances — there are disturbing issues about HCV that must be raised, particularly when it is said to have infected some 4 million Americans, the vast majority of

whom have no symptoms and have been frightened out of their wits that they’ll eventually develop fatal liver disease. HCV is said to spread through direct contact with contaminated blood; that means through such routes as sex, sharing needles for drug use and, of course, blood transfusions, particularly from the 1960s through the ’80s when the blood supply wasn’t adequately tested for HCV. The stakes here are obviously very high for people diagnosed with HCV and for society in general. We’d better have good fundamental science serving as the foundation for very expensive testing programs, treatment

regimens and public health promotion about a “hidden epidemic” on the rampage. Molecular Misdirection Keep in mind that it takes only a handful of researchers and some good marketing to set others on a course that, even if misdirected, becomes difficult to reverse. This is particularly true in today’s world of molecular biology, in which basic discoveries, in the form of molecular products or tests,

are often accepted without challenge as baselines for further research, and, of course, the scramble for research dollars. Most doctors who see patients must accept this basic science on blind faith, due to their own lack of scientific expertise or the time to read the research papers. They then pass on their accepting views to patients, who typically assume they’ve been told “the truth.” In 1987, a scientific research team went on the hunt for a virus to explain liver disease linked to what was then called non-A non-B hepatitis. The team, including scientists from the CDC, Chiron Corp. and others, claimed to have detected HCV. But to this day, no one has ever been able to isolate such a virus in an intact form, nor has anyone been able to grow it in a

culture. And no one has been able to fish out such a virus, purify it (meaning separate it from a cell), inject it into an animal and cause hepatitis. No one has ever been able to document, according to basic long-held standards of virology, that such a proposed virus is infectious. No one. Fishing Expedition From the beginning, the researchers presumed too much in making their claim. They began by injecting blood from hepatitis patients into chimps. In half of the animals, they noted signs of infection in the form of a biological marker of hepatitis called alanine aminotransferase. The injected blood, however, did not cause hepatitis. That should have been a big red flag. The marker they detected may have had nothing to do with a virus. In any case, the scientists began fishing in liver tissue to find one. What they found, with the use of high-tech amplification tools, was essentially a small piece of genetic information (encoded in ribonucleic acid, or

RNA). On the basis of tests to reconstruct pieces of what they believed was a virus, they presumed that this bit of RNA was foreign and viral — even though they had no basic evidence that their “catch” behaved like a virus. But never mind. Just clone the pieces of genetic information; work out the genetic sequences; using indirect methods, generate proteins presumably coming from a virus’s genetic code; create an antibody test against this genetic information; test many patients who turn out to be positive against this genetic information — and lo and behold, you have an epidemic. Marketing Science Then, of course, all of the followers of the leaders must then publish thousands of scientific papers (which they did) studying the bits and pieces of genetic information presumed to be a virus. And they must do so to keep their labs going, particularly at a time when everyone is clawing for research support to keep their academic enterprise alive. This is not science. When you generate the basis of an epidemic and nowhere have you properly isolated the virus and shown it to be infective and disease-causing, you are making a mockery of the scientific

method. Now what about this “genetic information” that is presumed to be a virus? Some scientists have already suggested, on the basis of highly-detailed research (published in 1997) on cells from healthy human subjects who aren’t antibody positive to HCV, that some of that so-called viral genetic information may be similar to what is found normally in human cells — specifically, cell-escaping sequences of DNA via its RNA messenger. In other words, some of the genetic information thought to be a virus may actually have a human origin. How very intriguing. Rule Out Before Ruling In But to a thoughtful molecular biologist, such a proposition makes a lot of sense. One of the people I consulted was Strohman, professor emeritus of molecular and cell biology at the University of California. Strohman points out what any reasonable molecular biologist should know: toxic hits, say, for example, smoking and

alcohol consumption, can traumatize the liver and cause some genetic instability in its cells. In other words, the human cell itself can certainly be the source of the kind of genetic information caught in a molecular fishing expedition and presumed to be viral. Before jumping on a viral bandwagon, every effort should be made to thoroughly rule this out. It bothers Strohman that in the case of HCV, it has not. It also bothers him that the supposed detection of the HCV has been credited for lowering the post-transfusion rate of non-A non-B hepatitis. Better screening equals much less infection, or so goes the logic. But this is another example of pole-vaulting.

There may be other reasons for the decline, including the elimination of many donors at risk for AIDS. Direct Evidence? In last week’s column, I raised the challenge to the

scientific community to send me some evidence that a virus exists. The fact is, a virus might indeed exist and contribute to non-A non-B hepatitis, but the evidence so far is only indirect and circumstantial and, I believe, highly misleading, given the extreme to which it has been pushed. I have some time I can set aside later this summer to debate anyone from the molecular biology establishment who has been at the forefront of the discovery of HCV. No pretenders to the throne or angry followers of the leaders need apply. In the meantime, given the huge amount of tax dollars being appropriated and the numerous biotech industry programs that have emerged to fight HCV, I plan this week to contact a congressional committee known for its investigation of scientific issues and ask that they seriously

consider launching a probe of the science behind this vapor-like virus. Next week, I’ll focus on some on the important issues hepatitis patients are raising about their disease and the science and doctoring behind it. Regush produces medical features for ABCNEWS. In his weekly column, published Wednesdays, he looks at medical trouble spots, heralds innovative achievements and analyzes health trends that may greatly influence our lives. His latest book is The Breaking Point: Understanding your Potential for

Violence. http://abcnews.go.com/sections/living/SecondOpinion/secondopinion_44.html Second Opinion December 18, 2000 Hepatitis C Reconsidered Old Research Raises Still-Valid

Questions Regush has been flooded with letters in response to his first two columns on hepatitis C, most lambasting him for questioning the mainstream view on the disease. (ABCNEWS.com) By Regush First, some reassuring and potentially empowering information about a disease named hepatitis C. Of all the studies I’ve examined in the past several weeks, one older

one looms large as the first to offer patients a measure of hope and food for thought. It’s a large-scale, long-term study published back in 1992 in the New England Journal of Medicine (Volume 327, No.27, pages 1906-1911) , and while it should not be seen as definitive, it is most instructive as a way of thinking about the disease. The study, which followed transfusion-related non-A non-B hepatitis patients for 18 years and matched them with control subjects who received transfusions but didn’t have the disease, informs us

that it appears to be uncommon for the disease to result in dire problems. The study concluded that those believed to have been infected with the hepatitis C virus (associated with most cases of non-A non- live as long overall as those with no infection. Silent Progression There was, however, a small increase over time in the number of deaths specifically associated with liver disease in patients with non-A non-B, suggesting that it takes a very long time indeed for the disease to

take its final toll. What can we make of such data? The optimist might conclude that the virus won’t reduce overall survival rates over time, and that increased numbers of liver-disease-related deaths that the study documented in infected patients might actually be due to intervening factors, including alcohol consumption. But as an editorial in the same issue of the Journal cautioned, a much longer-term follow-up of patients may well show a tide of death related to the virus. And the editorial also called for more research on the effects of the disease, and not just on how long people live. What this study immediately tells me is that evidence for a viral cause of non-A non-B is open to question. It raises a big red flag because of the time it appears to take this virus to do its dirty work. Other data suggest that it doesn’t even cause symptoms beyond a conventional flu-like illness in many people, even for decades. When science lines up behind a virus whose damage potential extends into many decades, I get suspicious. Is Evidence Lacking? So I did some checking. Those of you who read my last two columns know that I have come away from the voluminous data on the hepatitis C virus convinced that science has made a huge mistake. There is no good evidence that such a virus exists. I concluded that the scientists who made the initial discovery made fanciful leaps; consequently these leaps became the basis for further studies and entrenched beliefs. My view is that the cause of non-A non-B hepatitis remains unknown. Some 4 million Americans are said to be already infected with the hepatitis C virus. If I knew that I were among them, I would make it a major

commitment to uncover everything I possibly could about this virus and the claims underlying its identification. I would stop at nothing to get a good fix on the virus because that knowledge would certainly affect how I live my life, how I would assess my chances of becoming ill and which treatments I might deem appropriate. Strength in Numbers I would try to associate with others affected by the disease who also had a burning desire to raise questions about the virus. I would make an effort to acquaint myself with the fundamental science and I would be particularly interested in following up any challenges to that science. I would consider it foolhardy to automatically accept the conventional wisdom. What is considered mainstream today in science might well be built on the basis of medical politics and corrupted research. I would take special care not to associate with organizations or support groups that would insist on following the CW and which would be immediately antagonistic to non-conventional thinking

about the disease. And I would be particularly cautious about joining up with any patient group that was supported by pharmaceutical funds or led by lay people and doctors alike who appeared to be toeing some official line, or, for that matter, using the vehicle of a support group or voluntary association to enlarge their egos. I would much rather seek the support of independent spirits who gave me the empowered feeling that I was free to pursue any and all information about the disease. E-mail

Overload I am writing this because of the nature of many of the letters that I have been flooded with in response to my first two columns on this issue. Most have come from patients or patient support groups that lambasted me for questioning the mainstream view on non-A non-B hepatitis. Rather than raise questions or indicate that they were interested in knowing more about my views, they settled for name-calling and, in some cases, threats to my well-being. Well, I don’t care much if people call me names and I can either live with

threats or refer them to police authorities if they get out of hand. What I find very disturbing is the fact that so many people would be unwilling to further explore the nature of their disease. Rather than pummel me, these patients and support groups should delve into the questions being raised about non-A non-B, not only by me but by others, including some prominent scientists. One would think that taking this route might become an empowering experience. In any case, to those patients and support group members who did write that they would look into the issues that I raised, I can only

applaud your willingness to have an open mind. This is what it will take to get to the bottom of what this disease is all about. And please stay tuned. In the weeks and months ahead, I’ll occasionally update you on my own burning desire to make scientists working on non-A non-B accountable for their claims. I’ll also let you know if anyone involved in the discovery of the so-called hepatitis C virus has the guts to take up my challenge to publicly debate me on the scientific issues. Regush produces medical features for ABCNEWS. In his weekly column, published Wednesdays, he looks at medical trouble spots, heralds innovative achievements and analyzes health trends that may greatly influence our lives. His latest book is The Breaking Point: Understanding your Potential for Violence. "Slow Viruses: The Original Sin Against the Laws of Virology" Phantom Viruses and Big Bucks Most virus hunters prefer chasing real, if arguably harmless, viruses as their deadly enemies. But Gajdusek's "unconventional" viruses - the ones neither he nor anyone else have ever found - have been making a comeback in recent years. Given the abundance of research dollars being poured into biomedical science by the NIH and other agencies, opportunistic virus hunters have been finding creative ways to cash in. One increasingly successful method utilizes modern biotechnology to isolate viruses that may not even exist. Hepatitis, or liver disease, has yielded profitable virus-hunting opportunities in recent years... ...This form of hepatitis [hepatitis C] does not behave as an infectious disease, for it rigidly confines itself to people in well-defined risk groups rather than spreading to larger

populations or even to the doctors treating hepatitis patients. Yet virologists have been eyeing the disease from the beginning, hoping one day to find a virus causing it. That day arrived in 1987. The laboratory for the job was no less than the research facility of the Chiron Corporation, a biotechnology company located directly across the bay from San Francisco. Equipped with the most advanced techniques, a research team started its search in 1982 by injecting blood from patients into chimpanzees. None of

monkeys contracted hepatitis, although subtle signs vaguely resembling infection or reddening did appear. For the next step, the scientists probed liver tissue for a virus. None could be found. Growing desperate, the team fished even for the smallest print of a virus, finally coming across and greatly amplifying a small piece of genetic information, encoded in a molecule known as ribonucleic acid (RNA), that did not seem to belong in the host's genetic code. This fragment of presumably foreign RNA, the researchers assumed, must be the genetic information of some undetected virus. Whatever it

was, liver tissue contains it only in barely detectable amounts. Only about half of all hepatitis C patients contain the rare foreign RNA. And in those who contain it, there is only one RNA molecule for every ten liver cells - hardly a plausible cause for disease. The Chiron team used newly available technology to reconstruct pieces of the mystery virus. Now they could test patients for antibodies against this hypothetical virus and soon discovered that only a slight majority of hepatitis C patients had any evidence of these antibodies in their blood. Koch's first postulate, of course, demands that a truly harmful virus be found in huge quantities in every single patient. His second postulate requires that the virus particles be isolated and grown, although this supposed hepatitis virus has never been found intact. And the third postulate insists that newly infected animals, such as chimpanzees, should get the disease when injected with the virus. This hypothetical microbe fails all three tests. But Koch's standards were the furthest thing from the minds of the Chiron scientists when they

announced in 1987 that they had finally found the "hepatitis C" virus. Now more paradoxes are confronting the viral hypothesis. Huge numbers of people testing positive for the hypothetical hepatitis C virus never develop any symptoms of the disease, even though the "virus" is no less active in their bodies than in hepatitis patients. And according to a recent large-scale study of people watched for eighteen years, those with signs of "infection" live just as long as those without Despite these facts, scientists defend their still-elusive virus by

giving it an undefined latent period extending into decades. Paradoxes like these no longer faze the virus-hunting research establishment. Indeed, rewards are generally showered upon any new virus hypothesis, no matter how bizarre. Chiron did not spend five years creating its own virus for nothing. Having patented the test for the virus, the company put it into production and began a publicity campaign to win powerful allies. The first step was a paper published in Science, the world's most prestigious science magazine, edited by Dan Koshland, Jr.,

professor of molecular and cell biology at the University of California at Berkeley. Penhoet, chief executive officer for Chiron, also holds a position as professor of molecular and cell biology at the University of Californi at Berkeley. The NIH-supported virology establishment soon lent the full weight of its credibility to the hepatitis C virus camp. As Chiron's CEO boasted, "We have a blockbuster product." A regulatory order from the Food and Drug Administration (FDA) to test the blood supply would reap enormous sales for Chiron. Their big chance presented itself in late 1988

as a special request from Japanese Emperor Hirohito's doctors. The monarch was dying and constantly needed blood transfusions; could Chiron provide a test to make sure he received no blood tainted with hepatitis C? The biotech company jumped at the opportunity, making for itself such a name in Japan that the Tokyo government gave the product its approval within one year. The emperor died in the meantime, but excitement over Chiron's test was fueled when the Japanese government placed hepatitis C high on its medical priority list. Chiron's test kit now earns some $60 million annually in that

country alone. By the middle of 1990, the United States followed suit. The FDA not only approved the test, but even recommended the universal testing of donated blood. The American Association of Blood Banks followed suit by mandating the $5 test for all 12 million blood donations made each year in this country - raking in another $60 million annually for Chiron while raising the nation's medical costs that much more. And all this testing is being done for a virus that has never been isolated. Profits from the test kit have generated another all-too-common part of virus hunting. With Chiron's new income from the hepatitis C test, Penhoet's company bought out Cetus, another biotech company, founded by Glaser, who, like Penhoet, also holds a position as professor of molecular

and cell biology at the University of California at Berkeley. And Chiron made an unrestricted donation of about 12 million to the Department of Molecular and Cell Biology at the University of California at Berkeley that generates $100,000 in interest each year. Unfortunately for the writer of this article, Dr. Duesberg senior researcher at the University of California, he belongs to the same department, his supervisor, a professor who consults for Chiron Corporation - and displays little sympathy for Duesberg for challenging modern virus hunting by restricting his academic duties to undergraduate student teaching and by not appointing him to

decision-making committees. Such conflicts of interest have become standard fixtures in university biology departments. Hepatitis C: An Update By Bren (staff writer for FDA Consumer) Full article: http://www.mamashealth.com/infect/hepcupdate.asp It's often portrayed as a virus causing an incurable disease--a killer with few outward warning signs that lurks inside the body and slowly ravages the liver. For some, the hepatitis C virus (HCV) is deadly, but for most of the nearly 4 million Americans infected with the virus, it is not life-threatening. "Some cases are mild, and people can go through their whole lives and never have a problem," says Leonard Seeff, M.D., a hepatologist at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)." For others who develop severe liver disease, it is a terribly serious problem." Despite many years of chronic infection, the majority of people infected with HCV do not develop severe liver disease, and some may not need treatment, says Schwieterman, M.D., chief of the immunology and infectious diseases branch in the Food and Drug Administration's Center for Biologics Evaluation and Research

(CBER). Most studies report that cirrhosis (advanced liver scarring) develops in 10 percent to 20 percent of people with chronic HCV infection over a period of 20 to 30 years. Liver cancer develops in 1 percent to 5 percent. PEG-Intron and Ribavirin. The goal of treatment is sustained response--meaning that the virus is not measurable in the blood after drug therapy is completed. Those who continue to have measurable levels of the virus after treatment are considered non-responders. Relapsers "clear" the virus during therapy or shortly

thereafter, but the virus returns after therapy ends. About half of the people who initially respond to monotherapy (interferon alone) relapse. There is no absolute way to know who will or won't respond to therapy Because of interferon's potentially serious side effects, the products come with an FDA-approved medication guide written for patients. Under regulations that became effective in 1999, pharmacists must distribute a medication guide with products that the FDA has determined pose a serious risk and for

which patient guidelines can help prevent that risk. The guide for interferon products lists both the common, less serious side effects, and the rarer but potentially life-threatening ones. The common side effects include "flu-like" symptoms, extreme fatigue, nausea and loss of appetite, thyroid problems, high blood sugar, hair loss, and skin reactions (such as redness and itching at the injection site). Possible serious side effects are psychoses or suicidal behavior, heart problems (low blood pressure, heart attack), other internal organ damage, blood problems (blood counts falling dangerously low), and new or worsening autoimmune disease (such as

rheumatoid arthritis). Side effects of ribavirin, the oral part of the combination therapy, include anemia, fatigue, irritability, skin rash, nasal stuffiness, sinusitis, and cough. Ribavirin can also cause birth defects, so pregnancy in female patients and female partners of male patients must be avoided during treatment and for six months afterward.

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May 23, 2006