Cherry Blossoms

Introduction to GCP

Sat, 19 Dec 2009 13:43:37 -0000

A very very brief introduction to ICH's GCP,
after the 'read more' jump

Merk & Elsevier: Published FAKE peer-reviewed journal

Mon, 04 May 2009 01:50:00 -0000

I am speechless!

Merck paid an undisclosed sum to Elsevier to produce several volumes of a publication that had the look of a peer-reviewed medical journal, but contained only reprinted or summarized articles--most of which presented data favorable to Merck products--that appeared to act solely as marketing tools with no disclosure of company sponsorship. ...

The Australasian Journal of Bone and Joint Medicine, which was published by Exerpta Medica, a division of scientific publishing juggernaut Elsevier, is not indexed in the MEDLINE database, and has no website (not even a defunct one). The Scientist obtained two issues of the journal: Volume 2, Issues 1 and 2, both dated 2003. The issues contained little in the way of advertisements apart from ads for Fosamax, a Merck drug for osteoporosis, and Vioxx. (Click here and here to view PDFs of the two issues.) ...

In testimony provided at the trial last week, which was obtained by The Scientist, George Jelinek, an Australian physician and long-time member of the World Association of Medical Editors, reviewed four issues of the journal that were published from 2003-2004. An "average reader" (presumably a doctor) could easily mistake the publication for a "genuine" peer reviewed medical journal, he said in his testimony. "Only close inspection of the journals, along with knowledge of medical journals and publishing conventions, enabled me to determine that the Journal was not, in fact, a peer reviewed medical journal, but instead a marketing publication for MSD[A]."

He also stated that four of the 21 articles featured in the first issue he reviewed referred to Fosamax. In the second issue, nine of the 29 articles related to Vioxx, and another 12 to Fosamax. All of these articles presented positive conclusions regarding the MSDA drugs. "I can understand why a pharmaceutical company would collect a number of research papers with results favourable to their products and make these available to doctors," Jelinek said at the trial. "This is straightforward marketing."

Converts wished silenty for Christianity and its terrors

Sat, 19 May 2007 03:42:20 -0000

Catholic Arrogance finds outlet in its Pope.
The Oft used excuse of Rapists is that the victim 'asked for it'.

The Pope's assertation that the Indigenous Natives of America who were converted by force and coercion after largescale massacres, rape and looting were actually 'silently longing' for all this, is no better than a rapists' apologetics.

Indigenous leaders in Brazil have reacted angrily to Pope Benedict's comments that their predecessors had willingly converted to Christianity.

One Amazon Indian leader, Jecinaldo Satere Mawe, said the Pope's remarks had been arrogant and disrespectful.

Pope Benedict XVI told Latin American bishops in Brazil that American Indians had been "silently longing" to become Christians 500 years ago.

The Pope has now returned home after his five-day trip to Brazil.

The Vatican has made no further comment.

'Wrong and indefensible'

The BBC's Emilio San Pedro said the Pope had said the Christianisation of the region had not involved an alienation of the pre-Colombian cultures.

Our correspondent said Pope Benedict also made no mention of the violent history that followed or the documented decimation of native cultures in favour of the Christian model Conquistadores and other Europeans colonisers.

He said the comments had even been criticised by the Catholic Church's Indian advocacy group in Brazil, which described the Pope's statement as wrong and indefensible.

Vishnu Murti of Ancient Rus

Thu, 04 Jan 2007 09:27:45 -0000

An ancient Vishnu idol has been found during excavation in an old village in Russia's Volga region, raising questions about the prevalent view on the origin of ancient Russia.

The idol found in Staraya (old) Maina village dates back to VII-X century AD.

Staraya Maina village in Ulyanovsk region was a highly populated city 1700 years ago, much older than Kiev, so far believed to be the mother of all Russian cities.

"We may consider it incredible, but we have ground to assert that Middle-Volga region was the original land of Ancient Rus. This is a hypothesis, but a hypothesis, which requires thorough research," Reader of Ulyanovsk State University's archaeology department Dr Alexander Kozhevin told state-run television Vesti.

Dr Kozhevin, who has been working in Staraya Maina for last seven years, said that every single square metre of the surroundings of the ancient town situated on the banks of Samara, a tributary of Volga, is studded with antiques.

Prior to unearthing of the Vishnu idol, Dr Kozhevin has already found ancient coins, pendants, rings and fragments of weapons.

He believes that today's Staraya Maina, a town of eight thousand, was ten times more populated in the ancient times.

It is from here that people started migrating to the Don and Dneiper rivers around the time ancient Russy built the city of Kiev, now the capital of Ukraine.

An international conference is being organised later this year to study the legacy of the ancient village, which can radically change the history of ancient Russia.

Artificial Blood Replacement completes trials

Sun, 05 Nov 2006 14:58:54 -0000

Oxycyte, an artificial blood replacement desiged for critical and trauma care, carries oxygen 50 times as effectively as normal human blood.

Oxycyte has recently completed trials and emerged as a promising way to get the all critical oxygen to the brain tissues in Trauma and Reanimation scenarios.

BUYING SYNTHETIC
A wonder drug, perhaps, but one with caveats. Most of those in the artificial-blood world, like Steven A. Gould, the CEO of Northfield Laboratories in Evanston, Illinois, have hedged their bets on the more common hemoglobin-based substitutes. Northfield’s PolyHeme, for instance, has recently completed its last clinical trial; the company is now compiling its data for the FDA to review.

“The benefit of hemoglobin-based oxygen carriers is that oxygen is loaded onto them when we’re breathing room air,” Gould says. That is, hemoglobin-based substitutes work just like our own blood. To get the full effect from Oxycyte, on the other hand, a patient breathes in 50 to 100 percent oxygen four hours before receiving it and for 12 hours after it’s infused (air contains 21 percent oxygen). “That’s a logistical limitation,” Gould says, “and in general, it’s preferable not to breathe supplemental oxygen if it can be avoided.”

Most of today’s ambulances carry oxygen on board, as do military rescue helicopters, so the problem isn’t getting a tank of air to the patient. It’s the risk of inhaling supplemental oxygen for too long. Scientists know that pure oxygen increases the number of free radicals in our bloodstream, which can damage tissues and membranes, but the long-term severity of that damage is unknown. Spiess believes that Oxycyte could still work at even lower levels of oxygen, or even with room air, but he hasn’t yet been able to test out either of those scenarios on humans.

And there are other, undeniable side effects. In past PFC studies, patients were found to experience a transient swelling of the liver as it absorbed the oily molecules of the PFC; some patients demonstrated a decrease in platelet count, which can hinder the blood’s ability to clot; and some suffered short-term flu-like effects. Spiess has a quick response to concerns like these: “If you’ve been hit in the head or you’ve been shot or you’re having a stroke, you don’t sweat the flu-like symptoms.” All drugs have some measure of toxicity, Spiess says. It’s simply a case of the good outweighing the bad.

Although the sample size is far too small to be statistically definitive, it seems that VCURES’s brain-injury trial may be an example of just that. By August, the hospital had enrolled all of the eight patients it needed to complete the Phase II study. Even at the best trauma centers in the world, the mortality rate for TBI victims is one in three. Of the eight patients Spiess and Bullock treated with Oxycyte, only one died. The recovery process for the surviving patients has been unusually smooth.

Extraordinarily so, in Bess-Lyn’s case. After regaining consciousness two weeks after the accident, she recovered movement in her paralyzed right side and was ultimately deemed well enough to leave rehab a week earlier than predicted. She is expected to make a full recovery. Meanwhile, Spiess and Bullock are busy designing a larger trial that will bring their oxygen therapy to emergency rooms across the country—perhaps as soon as next year.

Turmeric Prevents Rheumatoid Arthritis, Bone Loss

Tue, 31 Oct 2006 15:40:19 -0000

Turmeric, an established Ayurvedic Anti-Inflammatory drug was the subject of a study which threw up interesting facts.. and results.

An ancient spice, long used in traditional Asian medicine, may hold promise for the prevention of both rheumatoid arthritis and osteoporosis, according to a recently completed study at The University of Arizona College of Medicine.

Turmeric, the spice that flavors and gives its yellow color to many curries and other foods, has been used for centuries by practitioners of Ayurvedic medicine to treat inflammatory disorders. Turmeric extract containing the ingredient curcumin is marketed widely in the Western world as a dietary supplement for the treatment and prevention of a variety of disorders, including arthritis.

At the UA College of Medicine, Janet L. Funk, MD, working with Barbara N. Timmermann, PhD, then-director of the National Institutes of Health (NIH)-funded Arizona Center for Phytomedicine Research at the UA, set out to determine whether (and how) turmeric works as an anti-arthritic. They began by preparing their own extracts from the rhizome, or root, of the plant, providing themselves with well-characterized materials to test and to compare with commercially available products. (Dr. Timmermann since has joined the faculty of the University of Kansas, Lawrence, Kan.)

Dr. Funk and her colleagues then tested in animal models a whole extract of turmeric root, only the essential oils, and an oil-depleted extract containing the three major curcuminoids found in the rhizome. Of the three extracts, the one containing the major curcuminoids was most similar in chemical composition to commercially available turmeric dietary supplements. It also was the most effective, completely inhibiting the onset of rheumatoid arthritis.

Dr. Funk, an endocrinologist in the UA Department of Medicine, says this study provides several noteworthy "firsts." Completed with the researchers' own prepared, well-defined extracts, the study represents the first documentation of the chemical composition of a curcumin-containing extract tested in a living organism, in vivo, for anti-arthritic efficacy. It also provides the first evidence of anti-arthritic efficacy of a complex turmeric extract that is analogous in composition to turmeric dietary supplements.

The significance, she explains, is that translating the results of trials such as these to clinical use depends on accurate information about the chemical content and biological activity of the botanical supplements available for use. This work paves the way for the preclinical and clinical trials needed before turmeric supplements can be recommended for medicinal use in preventing or suppressing rheumatoid arthritis.

However, as many of Indian indegeneous herbs and traditional remedies are being studied with added interest, the chances of Indian traditional medical system being absorbed and ultimately done with, looms large.
If our experiences with Basmati and Neem are any indications, this overt take over of Traditional Indian Knowledgebase will go unchallenged, while Indian Government will spend its attention over ways to talk to Pakistan amidst continued terror attacks and retrograde minority appleasement policies.

In this regard, the pioneering work by Mr. Rajiv Malhotra of Infinity Foundation needs mention.
Rajiv Malhotra is single handledly fighting a long drawn process by Westerners taking over Indian tradions and lore, assimilating it and then claiming them as their own..

Westerners appropriate Indic ideas through a process which Rajiv Malhotra has called the U-Turn. In its basic form the U-Turn Theory states that a member of the dominant Western culture first whole-heartedly learns the Indic tradition. He or she, for a variety of reasons, then repackages it and projects the knowledge gained from India from within his/her own culture. The next thing you know is that s/he claims these ideas were always an integral part of Western culture. Some, but not all, also start demonizing the source Indic traditions using a lot of pretexts, such as calling them “world negating” or accusing them of “human rights” abuses. As an example, Malhotra has examined on how Jung appropriated much from Indic thought – including key ideas of collective unconscious, archetypes, and synchronicity – but did the classical U-Turn from Indic thought. In all, Malhotra has done 50+ case studies of such U-Turns, and each has its own story as to why and how it was done. U-Turns have played animportant role in shaping Western ideas, literature and popular culture; yet they are typically ignored in discussions on the history of ideas. The U-Turn Theory also explains that many Indians internalize the Western adaptations of Indian culture and re-import them into India: For instance, Tantric healing is more fashionable as “energy healing” or as reiki; yoga’s return to India’s Westernized middle class owes a lot to the West’s adoption of it; and Western research on cognitive science and neuroscience includes yogis who are mere “subjects.”

From: Science Daily

Lancet wades into politics marsh... Again?

Sun, 15 Oct 2006 17:50:00 -0000

The Lancet is no stranger to controversy. In fact it courts the worst kind of it - Political!

Perhaps its its high impact factor that nudges it and its left-leaning editor into taking up issues such as the Iraq war, but seriously, does it really serve its stated mission?

Advancing medicine, by delivering superior education, reference information and decision support tools to doctors, nurses, health practitioners and students.

Oh yeah.

The Lancet's history of serious wobbling started with its publication of a paper in 1998 which tried to link MMR Vaccine with Autism! The last I heard about it, the controversy is still on. The Jan 2006 scandal of the fabricated 'Non-steroidal anti-inflammatory drugs and the risk of oral cancer: a nested case-control study' was enough for the Vancouver Guidelines to be updated with new guidelines and ethical consideration rules.

The 2004 Controversial estimate of Iraq war's death toll of Iraqis of the Lancet brought it into the mainstream glare of critical 'fact checking' crowd online...
And now, they come up with this:

"About 100,000 Iraqi civilians -- half of them women and children -- have died in Iraq since the invasion, mostly as a result of airstrikes by coalition forces, according to the first reliable study of the death toll from Iraqi and US public health experts. "

The Guadian discusses it and writes:

100,000 Iraqi civilians dead, says study
About 100,000 Iraqi civilians - half of them women and children - have died in Iraq since the invasion, mostly as a result of airstrikes by coalition forces, according to the first reliable study of the death toll from Iraqi and US public health experts.
The study, which was carried out in 33 randomly-chosen neighbourhoods of Iraq representative of the entire population, shows that violence is now the leading cause of death in Iraq. Before the invasion, most people died of heart attacks, stroke and chronic illness. The risk of a violent death is now 58 times higher than it was before the invasion.

Last night the Lancet medical journal fast-tracked the survey to publication on its website after rapid, but extensive peer review and editing because, said Lancet editor Richard Horton, "of its importance to the evolving security situation in Iraq". But the findings raised important questions also for the governments of the United Sates and Britain who, said Dr Horton in a commentary, "must have considered the likely effects of their actions for civilians".

Pro-Choice Vs 3D Imagery

Wed, 04 Oct 2006 14:04:07 -0000

With the advent of 3D imagery of unborn babies, the debate between Pro-Choice and Pro-Life Camps just got notched up into an entirely new level of appeals to emotions and rationalism from either sides.

One can harly dismiss the powerful real time images of fetus moving, sipping amniotic fluid or even 'exhibiting emotions' with smiles... And the pro-lifers are having a difficult time convincing the public that these gestures and clear signs of life is just nothing but fasiculations of muscle bundles with no 'live human' behind it.

Well, that would apply to anybody under deep Anaesthesia as well, I should add...

Ultrasound images which show 12-week-old foetuses sucking their thumbs and walking in the womb are dangerously misleading, a group of scientists warned today.

The 3D images of unborn babies apparently behaving in a similar way to newborns raised questions over whether the upper limit for abortions should be reduced form 24 weeks.

From:

Solar Pyramids in Ukraine Discovered

Mon, 02 Oct 2006 13:30:00 -0000

Pyramids Older Than Egyptian Allegedly Found in Ukraine

Archaeologists in Ukraine have unearthed the remains of an ancient pyramidal structure that pre-dates those in Egypt by at least 300 years. The stone foundations of the structure, which probably resembled Aztec and Mayan ziggurats in South America, were discovered near the eastern city of Lugansk.

It is thought they were laid about five millennia ago during the early Bronze Age by animists who worshipped a sun god. The “pyramid” is in fact a complex of temples and sacrificial altars topping a sculpted hillside with steps on its sides.

Nobel Price for Medicine announced

Mon, 02 Oct 2006 13:08:37 -0000

"This year's Nobel laureates have discovered a fundamental mechanism for controlling the flow of genetic information,"

Americans Andrew Z. Fire and Craig C. Mello won the Nobel Prize in physiology or medicine Monday for discovering a powerful way to turn off the effect of specific genes, opening a new avenue for disease treatment.

"RNA interference" is already being widely used in basic science as a method to study the function of genes and it is being studied as a treatment for infections such as the AIDS and hepatitis viruses and for other conditions, including heart disease and cancer.

Fire, 47, of Stanford University, and Mello, 45, of the University of Massachusetts Medical School in Worcester, published their seminal work in 1998.

RNA interference occurs naturally in plants, animals, and humans. The Karolinska Institute in Stockholm, which awarded the prize, said it is important for regulating the activity of genes and helps defend against viral infection.