Data from the ADVANCE Study, involving 11,140 high-risk patients with type 2 diabetes, provides no evidence of an increased risk of death among those patients receiving aggressive treatment to lower blood glucose.

This contrasts findings from the 10,251 patient ACCORD trial which halted the intensive glucose control arm of the study 18 months early because a data review revealed that patients who received intensive treatment to lower blood glucose are at higher risk for death. While the trial will continue, patients will be transitioned from the intensive treatment arm (targeting A1c levels of
“Unlike what we saw in ACCORD, a rigorous review of ADVANCE data by the Data and Safety Monitoring Committee shows that the treatment strategy of intensively lowering blood sugar does not pose greater risk to our patients with type 2 diabetes”, says Canadian lead investigator and member of ADVANCE Management Committee Dr. Pavel Hamet, professor of Medicine, Canada Research Chair of Predictive Genomics at Université de Montréal and Chief, Gene Medicine Services at Centre Hospitalier de l’Université de Montréal. “ADVANCE is a landmark study and will continue as planned to completion. The results will provide crucial information to help us better reduce the significant health risks associated with type 2 diabetes.”

Type 2 diabetes increases the risk of many complications, especially cardiovascular disease, which is the leading cause of death in people with diabetes. Both the ADVANCE and ACCORD studies examined the effects of intensive blood glucose and blood pressure control on the risk of cardiovascular events such as heart attack, stroke, or death from cardiovascular disease in patients with type 2 diabetes. A successful reduction in overall and cardiovascular mortality in the intensive blood pressure arm has been reported from the ADVANCE trial and published in The Lancet in September 2007.

In ADVANCE and ACCORD, the intensive treatment arm targeted blood glucose levels below those recommended in current treatment guidelines because previous studies suggest that reducing blood sugar to levels to those found in non-diabetic adults may reduce the rate of cardiovascular disease in patients with diabetes.

In the ADVANCE trial, which involves 20 countries worldwide including Canada, the intensive blood glucose lowering program aimed to reduce levels of hemoglobin A1c (a marker of long term blood glucose control) to ≤6.5%. Treatment included a sulfonylurea drug, gliclazide modified release, for all patients, and a number of other agents for those patients unable to reach target blood glucose levels. The ADVANCE trial was started in 2001 and patients were followed for an average of five years.

Because the A1c targets in ACCORD and ADVANCE are similar, and the intensive blood glucose control arm of ACCORD was stopped early, the ADVANCE mortality data was reviewed by the Data and Safety Monitoring Committee to determine if there was a similar excess risk of mortality. This committee advised that data did not provide any confirmation of the adverse mortality trend reported from ACCORD.

“Final patient visits have been completed and the ADVANCE study data base is close to finalization. We expect to have definitive results soon,” said Study Director, Dr. Anushka Patel, from The George Institute in Sydney, Australia. “At this stage, the Data Monitoring and Safety Committee have reviewed results that are more than 99% complete, so we are confident that the interim findings are a reliable guide to the final results.”

Final data from the ADVANCE trial is expected to be promising in terms of risk minimization but multiple analyses are required before conclusions can be drawn regarding the effects of intensive glucose control on patient outcomes. Additional data will be available specifically from ADVANCE, and Dr. Hamet’s team, in collaboration with Prognomix in Montréal, is performing genomic studies of the risk of complications of diabetes in this unique worldwide patient cohort.

The ADVANCE trial was conducted by an independent collaborative group of medical researchers with support from the National Health & Medical Research Council of Australia and the Institut de Recherche Internationales Servier. The results of the blood pressure control arm of ADVANCE were presented at the annual meeting of the European Society of Cardiology in Vienna, Austria in September 2007. Final results of the glucose control arm of the ADVANCE trial will be released earlier than expected, by the middle of 2008.

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For further information, please contact:

Muriel Haraoui (English media relations)
HKDP Communications and Public Affairs

Genevieve Déry (French media relations)
HKDP Communications and Public Affairs
Sophie Langlois
Université de Montréal

Nathalie Forgue
Centre hospitalier de l’Université de Montréal

The Université de Montréal with its two affiliate schools, HEC Montréal and l’école Polytechnique, constitutes the leading centre for higher learning and research in Québec, the second in Canada, and one of the largest in North America. Its faculty of medicine is the largest in Canada in terms of student enrolment, and one of the major centres for health research in the country.

The Centre hospitalier de l’Université de Montréal (CHUM) provides specialized and ultra-specialized services to its regional and supraregional clienteles. Within its more immediate coverage area, CHUM also offers general and specialized hospital care and services. The CHUM has a five-part mandate, comprising research, teaching, the assessment of technologies and healthcare intervention methods, and the promotion of an integrated-networks approach to health care. H?tel-Dieu, H?pital Notre-Dame, and H?pital Saint-Luc form the CHUM, with 10,000 employees, 900 physicians, 270 researchers, 5,000 students and trainees and 800 volunteers providing services to more than 500,000 patients each year.

The George Institute for International Health is an internationally-recognized health research organization, undertaking high impact research across a broad health landscape. It is a leader in the clinical trials, health policy and capacity-building areas.

Prognomix is a Montreal biotech company focused on the discovery of genetic signatures associated with the complications of Type II Diabetes. The company is concentrating on developing a molecular diagnostic test pertinent for detection of risks to develop renal, ocular, cardiac, cerebral, vascular and other complications of diabetic disease.

The National Health & Medical Research Council of Australia is Australia’s peak body for supporting health and medical research; for developing health advice for the Australian community, health professionals and governments; and for providing advice on ethical behaviour in health care and in the conduct of health and medical research.

The Institut de Recherche Internationales Servier is the international research funding arm of the French pharmaceutical company, Servier. Servier manufactures modified release gliclazide (Diamicron MR™) and the fixed combination of perindopril and indapamide (registered under the following trade names; Preterax, BiPreterax, Preterax Forte, Biprel, Noliprel, Noliprel Forte, Prelectal, Prelectal forte, Predonium, Noliprel, Coversyl Plus, Coversyl Comp, Coversum Combi, Armix Comb, Prestarium Combi, Prestarium Plus).

Reference:
ADVANCE Collaborative Group; Patel A, MacMahon S, Chalmers J, Neal B, Woodward M, Billot L, Harrap S, Poulter N, Marre M, Cooper M, Glasziou P, Grobbee D, Hamet P, Heller S, Liu L, Mancia G, Mogensen C, Pan C, Rodgers A, Williams B. Effects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with type 2 diabetes mellitus (the ADVANCE trial): a randomised controlled trial. Lancet. 2007;370:829-40.

Source: Nathalie Forgue
University of Montreal

It’s very bad when I have a week off. Very, very bad.

The reason is that when I have a week off I have this rather unfortunate tendency to stay up late at night, and when I stay up late at night I have an even more unfortunate tendency to check out late night infomercials that show up between the hours of 2 AM and 4 AM. Such was the case the other night when I found myself sitting in bed bathing in the glow of the LCD screen, staring in utter awe at the woo I found. Even so, I still wondered whether I should use it for Your Friday Dose of Woo, given that this particular infomercial was covering ground that I had covered before. However, it’s been well over a year and a half, and this particular woo that assaulted me at around 2:30 AM is a bit different, although I’d be lying if I denied that it covered the usual altie obsession with “detoxification.” It does, but the infomercial raised my blood pressure sufficiently to get me to “honor” it by featuring it on our usual Friday exercise.

The product we’re talking about is Dual Action Cleanse, and your host for this late night excursion into woo peddling is this man:

This man is named Klee Irwin, and he sells colon cleansign woo. Joining Klee on this romp through your colon (or a least attempted romp) is “master herbalist” James Chappell:

“Dr.” Chappell calls himself “Doctor” based on these criteria:

In 1980 Dr. Chappell received his Bachelor of Science in Psychologyfrom Pacific Christian College in Fullerton, California. In 1977 Dr. Chappellreceived his Chiropractic Doctorate (D.C.) from the Cleveland ChiropracticSchool in Los Angeles, California. Dr. Chappell received his NaturopathicDoctorate (N.D.), from the Naturopathic College of California in Los Angeles,California in 1970. He also received his Doctor of Philosophy in HolisticNutrition (Ph.D.), from the Naturopathic College of California in Los Angeles,California in 1970. Prior to that Dr. Chappell received his Master HerbalistMedical Degree, (M.H.), from Dominican Herbal College in Quebec, Canada in 1969,and attended Ventura Junior College in Ventura, California from 1967 to 1968.

Would you buy some Super Colon Blow from men like this?

Sadly (or fortunately, depending upon your point of view), I missed the first few minutes of the infomercial. When I joined the action, Irwin and Chappell were holding an obviously highly scripted discussion in which I wondered if colon cleansing removes one’s ability to read cue cards properly. Maybe it affects the eyesight, too. Or maybe it causes that faux chipper affect that so annoys me when I see it in late night infomercials of this type. Whatever the case, while sitting there, the rest of there, the rest of the world asleep, becoming increasingly agitated by a woo attack to the point where I wanted to ask: “Who ya gonna call?”

Woobusters, of course.

Wait! I’m the woobuster. Oh, well, back to work, even as the level of gross (both size and in terms of the level of disgust) lies being thrown at me started to make me think that maybe I should have accepted that prescription for propranolol offered to me a while back by my doctor to keep my heart rate and blood pressure down. As I tried to shake the increasing impression that Klee Irwin bears an uncanny resemblance to a younger John Waters, I wondered if in fact John Waters was somehow responsible for the travesty that is this infomercial. Probably not, I concluded. At least John Waters knows how to be so over-the-top that he can be funny and entertaining.

If you were wondering if the “professional” input of “Dr.” James Chappell might make this infomercial somewhat more convincing than the usual infomercial of woo, you’ll be in for a big disappointment. One thing that he said that stuck in my mind came during the usual, predictable altie lament about how today we in modern society bathe in pollution, eat processed food, and use all sorts of vile chemicals, unlike the “golden era” they seem to pine for, when we supposedly lived at one with nature and were not subjected to any sorts of dangers like this at all, which, I suppose, is why the average life expectancy at birth now in industrialized countries is in the mid- to high 70s while centuries or millennia ago it was somewhere around 30 years. I suppose all that cleanliness didn’t protect us from huge rates of infant mortality due to diseases. Of course, pathogenic bacteria and viruses are all natural; so to alties they must be all good. In any case, get a load of this quote:

The human body was created to live off of a diet similar to how Americans ate 50 years ago.

Because everyone ate so much healthier and the environment had so many fewer pollutants in 1958, I suppose.

I won’t go into too much detail about many of the claims that also appeared on the infomercial, given that one of my earliest installments of YFDoW dealt with colon cleansing idiocy. Suffice it to say that Irwin and Chappell, as Tweedle-Dee and Tweedle-Dumber (TD&TD), vied valiantly to out-dumb each other as the show went on. After intoning the usual colon cleansing mantra “death begins in the colon,” they kept repeating misinformation that fecal matter somehow builds up in our colons so that by the time we are adults, particularly older adults, there is something like 20-30 pounds of impacted fecal matter lining the walls of our colons and releasing its “toxins” into the bloodstream. It’s all nonsense of course, as any gastroenterologist who does colonoscopies or surgeon who operates on the colon knows. Fecal matter does not cake up on the walls of the colon in general, and it takes a pretty significant colon obstruction or decrease in colon motility to result in autointoxication from the translocation of bacteria across the lining of the colon into the bloodstream. The run-of-the-mill granny who’s feeling a little constipated is incredibly unlikely to get into such problems. Of course, if you believe TD&TD, you’ll come to think that pretty much every vague symptom you ever have is due to not being sufficiently “clean” internally. That’s right: Fatigue, little aches and pains, you name it, it’s all caused by that horrible, toxic buildup of poo in your colon, of which you must purge yourself forthwith or risk horrific consequences!

Another thing that really stood out as primo grade A woo was the argument not just from antiquity but from ancient anecdote. TD&TD mentioned an Englishman named Thomas Parr, who, they had to point out, is buried in Westminster Abbey alongside kings and other English luminaries. What’s so amazing about Parr, according to TD&TD, is that he was born in 1483 and supposedly lived 152 years. Even more amazing, he supposedly married for the first time at age 80, the second time at age 122, and didn’t have his first child until age 130. Reports claim that he attributed his extreme longevity to a vegetarian diet and moral temperance. It’s not entirely clear whether his records were confused with those of his grandfather Thomas Parr, although it is fairly clear that he did live to be quite old, possibly even a centenarian. From this historical figure, who may or may not have lived 152 years but clearly did live a long time, TD&TD go off the rails, describing how famous surgeon William Harvey (who discovered the basics of the circulatory system) did an autopsy at the instruction of King Charles to find out why Parr lived so long. According to TD&TD, the autopsy showed that Parr’s organs were in “perfect condition” and that his colon was “as clean and healthy as that of a child.” Dr. Chappell, not surprisingly (this is an infomercial, after all) concludes, “The moral of this true story is: Keep your colon clean and you may have a very long and healthy life.”

Or it may be: Given the proscription against dissections of human bodies and the lack of knowledge about human physiology and anatomy, the conclusion of a surgeon of the early 1600s should be taken with a huge grain of salt, even if the surgeon is one as renowned as William Harvey. Or it may be: Have good genes and be lucky enough not to catch a serious infectious disease or to develop cancer, and you may have a very long and healthy life.

So what is this “Dual Action Cleanse” that TD&TD are trying to sell you? Basically, it consists of two products. One is called the “Total Body Purifier.” “Purifier”? Wow. Normally, I associate “purification” with religion, the perceived need to purify oneself of one’s sins, which make one “impure,” not medicine. Of course, colon cleansing is more like a religion or cult than anything else, in which, as in many religions, humans are viewed as a veritable cesspit of filth (original sin, anyone?) and require the “purification” that only the religion or cult can bring to be “clean” again. (Either that, or they’ve been watching Doctor Strangelove: Or, How I Stopped Worrying and Learned to Love the Bomb, specifically Gen. Jack D. Ripper, who had a rather unhealthy fascination with maintaining the purity of his “precious bodily fluids.” In any case, this “total body purifier” is nothing more than a mixture of all sorts of herbs listed with the usual vague claims that they “help boost the immune system,” “support the kidneys and respiratory system,” etc., all without any evidence that they do, in fact, boost the immune system or anything else.

The second part of the “Dual Action Cleanse” is the Colon Clear Formula. It, too, is a mixture of various herbs and concoctions that, it is claimed, clean out your colon to make it just as shiny and empty as that of a baby or that of Thomas Parr. Of course, what it appears to be is little more than a standard psyllium-based laxative chock full of woo-ful herbs and thus probably is nothing more than a very expensive version of Metamucil. With that as a background, it’s incredibly funny that TD&TD couldn’t resist a smackdown of a competitor’s product. That product is, even more hilariously, a colon cleans product hawked by a fundamentalist evangelical Christian. That product? Almighty Cleanse. I’m telling you, you can’t make stuff like this up. I always thought that making deceptive claims made baby Jesus cry, but apparently Almighty Cleanse makes Him poop happily and want you to poop happily too.

TD&TD didn’t like it one bit that the hawker of Almighty Cleanse claims that the product can clean out the colons of believers in a mere seven days (cleaning out their wallets takes even less time). Indeed, Infomercial Hell provided a clip that shows the two administering their righteous slapdown, pointing out how Dual Action Cleanse must be much better because it contains over 60 herbs and Almighty Cleanse only contains around 20 and ranting about how ridiculous it is to think that you can clean out “decades of accumulated waste” from your colon in a mere seven days:

Dual Action Cleanse Formula
by ColonHealth

Actually, it’s no more ridiculous than thinking that so many diseases are due to the “toxins” released from an “accumulation” of feces in our colons that actually doesn’t happen.

I can’t resist concluding by mentioning that there are few things as entertaining as watching a smackdown between woo peddlers. Personally, I can’t wait for the response from Almighty Cleanse. Will Danny Vierra retort that, with the power of God, given that Almight Cleanse is supposedly based on colon cleansing recipes included in the Bible, compels you to…poop! (Actually, I’ve been unable to find any instructions on how to cleanse one’s colon in the Bible, but I will confess that I haven’t done a truly exhaustive search.) Will he call the wrath of the Almighty down upon TD&TD for having the gall to challenge His Almighty Cleansing Formula? Will Vierra resort to the ultimate smear and call TD&TD atheists?

Inquiring minds want to know.

Of course, something that would be even more amusing were it not so despicable is that apparently TD&TD have not been good boys. Apparently the Los Angeles Better Business Bureau has received lots of complaints over their business practices. Maybe TD&TD do need a healthy dose of the Wrath of the Almighty to fall down upon them.

And maybe I need to get to bed earlier, even on weeks when I’m not working.

Feb. 28 — People suffering from age-related macular degeneration have twice the risk of dying from heart attack or stroke, Australian researchers report.

The degenerative eye disease is the most common cause of untreatable blindness among older adults in developed countries and affects the center of the retina at the back of the eye, which is essential for tasks such as reading and driving.

"We found a positive long-term link between AMD and subsequent cardiovascular and stroke mortality in a population of older Australians," said lead researcher Dr. Paul Mitchell, from the Centre for Vision Research in the Department of Ophthalmology at the University of Sydney. "This was particularly increased for late-blinding cases."

"Both ophthalmologists and general practitioners should be aware of this potential link and need to consider appropriate management of traditional vascular risk factors, such as smoking, blood pressure, blood lipids in their patients with AMD," Mitchell said.

In the study, Mitchell’s team studied 3,654 people aged 49 years old and older. Five years later, 2,335 people were re-examined, and after 10 years, 1,952 were re-examined.

The report is published in the Feb. 28 online issue of the British Journal of Ophthalmology.

The researchers found that for people under 75, when the study began, early AMD was linked with a doubling of their risk of dying from heart attack or stroke over the next 10 years.

For those with late-stage AMD at the start of the study, their risk of dying from heart attack increased fivefold, and their risk of dying from stroke increased 10 times, Mitchell’s team found.

"While AMD, particularly in its late stage, occurs in people of relatively older ages, it may be associated with an increased vascular risk," Mitchell said. "This could, in part, reflect shared risk factors such as smoking."

One expert noted that because AMD is a vascular problem, it is not surprising that it is associated with increased cardiovascular risk.

"Age-related macular degeneration and atherosclerotic vascular share common risk factors that include hypertension, hyperlipidemia and smoking," said Dr. Gregg C. Fonarow, a professor of cardiology at the University of California, Los Angeles.

In addition, systemic inflammation may increase the risk of AMD and atherosclerosis, Fonarow said.

"Just as having peripheral vascular disease is associated with an increased risk of cardiovascular disease through common risk factors, having AMD is associated with an increased risk of cardiovascular disease and mortality," Fonarow said.

"Patients and physicians should recognize that patients diagnosed with AMD are more likely to have underlying cardiovascular disease and subsequent events and take appropriate steps to lower that risk though lifestyle changes and cardiovascular protective therapies," Fonarow advised.

In another report in the same issue of the journal, British researchers concluded that genes that control the production of chemicals involved in inflammation may play a significant role in AMD.

One gene variation associated with the gene that produces an inflammatory chemical called interleukin 8, was significantly more common among people with AMD, the researchers found. This gene variant has been previously linked with inflammatory diseases and cancer.

If these findings hold up, the researchers think it could lead to genetic screening for AMD and possibly the development of medications to treat the disease.

SOURCES: Paul Mitchell, M.D., Centre for Vision Research, Department of Ophthalmology, University of Sydney, Australia; Gregg C. Fonarow, M.D., professor, cardiology, University of California, Los Angeles; Feb. 28, 2008, British Journal of Ophthalmology

In the last few days there has been widespread media coverage questioning the effect of antidepressant drugs, following the results of a study published in the journal Public Library of Science Medicine.The study suggested that some antidepressant drugs performed no better than dummy or placebo pills used in trials dating back to the 1980s.

Original post by Allergy News From Medical News Today

A protein that helps lung cancer cells thrive appears to do so by blocking healthy cells’ ability to fix themselves when radiation or chemicals, such as nicotine, damage their DNA, according to a University of Florida study to be published Friday (Feb. 29) in the journal Molecular Cell.High levels of the protein, known as Bc12, are found in the cells of lung cancer patients who smoke.

Original post by Diabetes Notes

Everyone has known for decades that smoking causes cancer, but until now no one really understood how cigarette smoke causes healthy lung cells to become cancerous. Researchers from the University of California, Davis, show that hydrogen peroxide in cigarette smoke causes lung cancer. This finding may help the tobacco industry develop “safer” cigarettes by eliminating such substances in the smoke, while giving medical researchers a new avenue to developing lung cancer treatments.

Original post by Allergy News From Medical News Today

A recent study published in the American Thoracic Society’s AmericanJournal of Respiratory and Critical Care Medicine reportsthat vitamin supplements do not protect against lung cancer, and may infact increase the risk of developing it.Dr. ChristopherG.

Original post by Diabetes Notes

An article appearing in the January/February issue of the Aesthetic Surgery Journal suggests that assessment of breast cancer risk prior to elective breast surgery can ultimately improve results for patients. The piece offers guidelines for plastic surgeons to help women gauge their breast cancer risk, and offer the best options for surgical intervention and reconstruction.

Original post by Allergy News From Medical News Today

Yissum Ltd., the Technology Transfer Company of the Hebrew University of Jerusalem, today announced that scientists from the School of Pharmacy at the Hebrew University of Jerusalem discovered a novel orally available drug that prevents metastasis formation in various types of cancers.

Original post by Allergy News From Medical News Today

Every year 4000 people die of asbestos which is more than those in road traffic accidents. In Great Britain we are in the middle of an epidemic and it is expected that asbestos deaths will to peak to nearly 5000 which is a legacy from years gone by.

Original post by Diabetes Notes