tagged w/ Clinical Trials
-
Help us persuade Congress to reform the agency with our Action Alert!
Drug research, even from clinical trials sponsored by the federal government, is routinely suppressed, according to a new study in the British Medical Journal (BMJ), an international peer-reviewed medical publication. The study found that less than half of all NIH-funded clinical drug trials were published in a medical journal within two and a half years of the trial’s completion—with fully one-third of trial results remaining unpublished even four years after the trial. Why? Because the drug manufacturers didn’t like the data.
One example cited in the study was the FDA-approved diabetes drug Avandia, which in 2007 was found to increase heart attacks and cardiovascular deaths—even though the drug’s maker, GlaxoSmithKline, had known about the risk before the drug was approved. The BMJ study found that 35 of the drug’s 42 clinical studies had never been published, and were obtained only because a court case required the pharmaceutical company to turn over the data.
Not only does this irresponsible practice harm patients, it also increases healthcare costs. Eugene Carragee, a Stanford University orthopedic surgeon and editor-in-chief of the Spine Journal, spearheaded an unprecedented independent analysis showing that the medical device manufacturer Medtronic—not to mention a circle of orthopedic surgeons who received millions of dollars in royalties from the company—systematically failed to report serious complications with Medtronic’s bone-growth stimulating back surgery device known as Infuse. The results of a crucial clinical trial of the product were not published until nearly five years after the trial had to be halted because unwanted bone was growing around the spines of the trial volunteers.
For two years, Schering-Plough, the maker of the popular cholesterol drug Vytorin, sat on the results of a clinical trial showing that the drug provided no benefit in improving artery health. During that time, the drug was heavily marketed to consumers in TV ads; the marketing was only halted in 2008 after a congressional investigation was launched.
In 2003, a clinical trial of Multaq, a drug that treated cardiac arrhythmias, was stopped because more patients who were getting the drug were dying than those who received a placebo—though the study results weren’t published until five years later. Even so, the drug was approved by the FDA in 2009 as a treatment for atrial fibrillation in certain patients—just not as a means to reduce deaths!
Why does FDA approve drugs whose data have been suppressed by the manufacturer? Is it because FDA depends on Big Pharma for its budget—and needs drug companies to hire former FDA employees. The Wall Street Journal reported that FDA advisers, in a recent vote, said the benefits of four popular Bayer AG birth control pills outweigh the blood clot risk. What the FDA didn’t disclose is that three of the advisers have had ties to Bayer, serving as consultants, speakers, or researchers!
Despite the FDA’s bias in favor of drugs and against supplements, there are tremendous shortages of some drugs (though no shortage of supplements—so far!). This drug shortage prompts some hospitals to engage in price gouging, so a drug that usually costs $26 is being offered for $1,200. Moreover, the FDA artificially inflates drug prices—especially generic drug prices, which should be far lower than they are—as we have reported previously.
The shortage in the US drug market also makes foreign counterfeit drugs more popular. Recently, some 65 million counterfeit pills were seized in China; no word yet on how many of them had already made their way to the US.
If this is the way FDA oversees dangerous drugs, what will happen if we give them the same authority over supplements? It’s not just that the agency doesn’t have the knowledge to properly oversee supplements—they also don’t have the capacity. If they can’t keep up with the hundreds of drugs already under their purview, how will they cope with the thousands of supplements on the market? One way, of course, is for them to drastically reduce the number of supplements that can be marketed—one inevitable result of the NDI draft guidelines that we have been campaigning against.
There must be sincere and honest people working for the US Food and Drug Administration, but it is currently being run in a corrupt and incompetent way. It desperately needs to be reformed. Please help us in our ongoing campaign to overhaul the agency by signing our petition to Congress. As we say in the petition, “Everything about the FDA must be taken apart, reviewed, redefined, and re-created so that it supports, not obstructs, the mission of advancing medical science and vibrant good health for all.” Please take action today!
http://www.anh-usa.org/big-pharma-suppresses-data/Help us persuade Congress to reform the agency with our Action Alert!
Drug... more
-
-
vaccine.html
This new therapy may stop 90% of cancers from coming back
-
-
I'm shocked! You mean that Big Pharma made fraudulent trials and made themselves look good? Shocked, I say. SHOCKED!I'm shocked! You mean that Big Pharma made fraudulent trials and made themselves... more
-
-
Peacey
-
added this
-
1 year ago
- |
-
During the German Nazi regime, human experimentation was carried out on large numbers of prisoners in concentration camps throughout World War II.
Experiments at Dachau concentration camp from 1942 to 1945, investigated immunization for treatment of malaria. Healthy inmates were infected by mosquitoes and after contracting the disease, the subjects were treated with various drugs to test their relative efficiency. Over 1,000 people were used in these experiments, and of those, more than half died as a result.
At Buchenwald concentration camp during 1943 and 1944, experiments were conducted to investigate the effect of various poisons. The poisons were secretly administered to experimental subjects in their food – the victims died as a result.
Doctors’ Trial
On August 19, 1947, the Nazi doctors captured by Allied forces were put on trial in USA vs. Karl Brandt et al., which is commonly known as the Doctors’ Trial. At the trial, several of the doctors argued in their defense that there was no international law regarding medical experimentation.
In response, a ten point memorandum was drafted entitled Permissible Medical Experiment. It went on to be known as the Nuremberg Code. The code calls for such standards as;
* voluntary consent of patients
* avoidance of unnecessary pain and suffering, and
* there must be a belief that the experimentation will not end in death or disability.
Point 7 of the code stated;
Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
However, the Code was not cited in any of the findings against the defendants and never made it into either German or American medical law.
Was it because human experimentation was secretly being carried out in America?
read full article at Heroin and Cornflakes....http://arch1design.com/blog/?p=8949During the German Nazi regime, human experimentation was carried out on large numbers... more
-
-
Use these helpful links to find current clinical studies in your area.
-
-
Merck was in trouble. In 2002, the pharmaceutical giant was falling behind its rivals in sales. Even worse, patents on five blockbuster drugs were about to expire, which would allow cheaper generics to flood the market. The company hadn't introduced a truly new product in three years, and its stock price was plummeting.
In interviews with the press, Edward Scolnick, Merck's research director, laid out his battle plan to restore the firm to preeminence. Key to his strategy was expanding the company's reach into the antidepressant market, where Merck had lagged while competitors like Pfizer and GlaxoSmithKline created some of the best-selling drugs in the world. "To remain dominant in the future," he told Forbes, "we need to dominate the central nervous system."
His plan hinged on the success of an experimental antidepressant codenamed MK-869. Still in clinical trials, it looked like every pharma executive's dream: a new kind of medication that exploited brain chemistry in innovative ways to promote feelings of well-being. The drug tested brilliantly early on, with minimal side effects, and Merck touted its game-changing potential at a meeting of 300 securities analysts.
Behind the scenes, however, MK-869 was starting to unravel. True, many test subjects treated with the medication felt their hopelessness and anxiety lift. But so did nearly the same number who took a placebo, a look-alike pill made of milk sugar or another inert substance given to groups of volunteers in clinical trials to gauge how much more effective the real drug is by comparison. The fact that taking a faux drug can powerfully improve some people's health—the so-called placebo effect—has long been considered an embarrassment to the serious practice of pharmacology.
Ultimately, Merck's foray into the antidepressant market failed. In subsequent tests, MK-869 turned out to be no more effective than a placebo. In the jargon of the industry, the trials crossed the futility boundary.
----------
Much much more at the link
http://www.wired.com/medtech/drugs/magazine/17-09/ff_placebo_effectMerck was in trouble. In 2002, the pharmaceutical giant was falling behind its rivals... more
-
-
The ever popular iPhone continues to amaze as it makes headway into industries that while logical, may not have seemed obvious – at first. One such industry is iPhone usage in the radiological sciences, where physicians have access to patient data in the standard DICOM image file format. In most cases, the delivery of the image data is achieved by incorporating the iPhone into the radiology workflow.
The actual mechanism is typically via a PACS solution, whereby, the iPhone is recognized as an “application entity”, therefore, recognizable as a device on the DICOM network that can receive and send medical image data from other DICOM enabled devices.
A number of companies have DICOM compliant applications that can be installed on the iPhone. They range from open source applications such as OsiriX Mobile (http://www.osirix-viewer.com/MobileOsiriXWorkflow.pdf) to commercially available applications such as MIMvista’s Mobile MIM (http://www.mimvista.com/iphone). Even major players such as GE Healthcare are getting involved. In the case of MIMvista, the company is very serious about its commitment to the iPhone as evidenced by its pursuit of FDA clearance for Mobile MIM.
These efforts are in response to a demand by the end users themselves, and have been presented at premier events in radiology, including the Radiological Society of North America (http://trusted.md/blog/radrounds/2008/11/10/apple_at_rsna_2008_osirix_iphone_and_macs_preview_and_schedule_of_events).
There is one gap that I have yet to see properly addressed within a regulatory framework in order to assure that variability in image display has been minimized. My research thus far has not uncovered any serious efforts to properly calibrate the iPhone display to the DICOM standard when used as a diagnostic tool for clinical interpretation. Because the iPhone has an internal ambient light sensor, my concern is even greater.
A white paper (http://www.planar.com/Advantages/WhitePapers/docs/WP_DICOM_Calibration.pdf) was written in 2005 by Planar (formally Dome Imaging), a company that provides DICOM compliant medical displays, which I consider to be essential reading on this topic. While this may appear to be self-serving, it is in fact a well written document on not only why this is important, but provides and analyses two approaches for calibrating LCD displays.
Theoretically, a USB-based photometer used in conjunction with a DICOM test pattern application should suffice with the initial and continual DICOM conformance. In practice, it may not be so easily achieved when all the variables of a mobile device are considered versus fixed devices usually found in reading rooms.
I would be interested to hear from end users, developers, and providers of medical imaging technology for the iPhone about this issue and the sense of significance and relevance it has on mobile devices used as medical devices.The ever popular iPhone continues to amaze as it makes headway into industries that... more
-
-
With the continued progress evolving from Desktops As A Service, Web OS’s, and the Cloud (virtualization), the time for serious discussion and debate of said technologies within medical imaging technology would seem appropriate.
The Remedy Project (Radiologic Medical Imaging Desktop Environment) seeks to host not only the outcomes of (hopefully) an engaging community, but to implement the best in class solutions, working toward the realization of its goals (discussed in future articles).
Enthusiasts of parallel industries such as the gaming industry have already weighed in on the good, bad and indifferent of what could be described as a paradigm shift in the “on demand” management and handling of complex data (http://perspectives.3ds.com/2009/07/27/cloud-computing-for-video-games-true-or-not/).
Medical imaging technology has challenges that extend beyond online gaming, for certain. It does however share commonalities from the algorithmic level up to the user experience.
One clear goal of the Remedy Project is to develop a technology roadmap for vested parties to implement within the realm of the open source community.
I welcome input from a diverse group of stakeholders who may indeed find a solution derived within Remedy is applicable to their respective goals, and vice versa.
Declan
Project OwnerWith the continued progress evolving from Desktops As A Service, Web OS’s, and... more
-
-
The difference between what drug companies tell the government and doctors suggests that they're cooking the books, which could mislead doctors making prescriptions.
Of 33 new drugs approved by the Food and Drug Administration in 2001 and 2002, one-fifth of supporting clinical trials were not published in medical journals, according to a new study. And those results that were published were often more positive than what companies presented to the FDA in their applications. As a result, potentially unreliable data is being used to promote drugs on which billions of dollars and thousands of lives may ride.
"Some studies aren't published at all. Then, when they are, there are little changes that make the papers look more favorable towards the product," said review co-author Lisa Bero, a University of California, San Francisco health policy expert.The difference between what drug companies tell the government and doctors suggests... more
-
-
From the report: A new type of drug could alleviate pain in a similar way to cannabis without affecting the brain, according to a new study published in the journal Pain on Monday 15 September.
The research demonstrates for the first time that cannabinoid receptors called CB2, which can be activated by cannabis use, are present in human sensory nerves in the peripheral nervous system, but are not present in a normal human brain.
Drugs which activate the CB2 receptors are able to block pain by stopping pain signals being transmitted in human sensory nerves, according to the study, led by researchers from Imperial College London.
Previous studies have mainly focused on the other receptor activated by cannabis use, known as CB1, which was believed to be the primary receptor involved in pain relief. However, as CB1 receptors are found in the brain, taking drugs which activate these receptors can lead to side-effects, such as drowsiness, dependence and psychosis, and also recreational abuse.
The new research indicates that drugs targeting CB2 receptors offer a new way of treating pain in clinical conditions where there are currently few effective or safe treatments, such as chronic pain caused by osteoarthritis and pain from nerve damage. It could also provide an alternative treatment for acute pain, such as that experienced following surgical operations.
The new study showed that CB2 receptors work to block pain with a mechanism similar to the one which opiate receptors use when activated by the powerful painkilling drug morphine. They hope that drugs which target CB2 might provide an alternative to morphine, which can have serious side effects such as dependency, nausea and vomiting.
Praveen Anand, Professor of Clinical Neurology and Principal Investigator of the study from the Division of Neurosciences and Mental Health at Imperial College London, said: "Although cannabis is probably best known as an illegal recreational drug, people have used it for medicinal purposes for centuries. Queen Victoria used it in tea to help with her period pains, and people with a variety of conditions say that it helps alleviate their symptoms.
"Our new study is very promising because it suggests that we could alleviate pain by targeting the cannabinoid receptor CB2 without causing the kinds of side-effects we associate with people using cannabis itself."
The researchers reached their conclusions after studying human sensory nerve cells in culture with CB2 receptor compounds provided by GlaxoSmithKline, and also injured nerves from patients with chronic pain.
The researchers are now planning to conduct clinical trials of drugs which target CB2 in patients with chronic pain at Imperial College Healthcare NHS Trust, which has integrated with Imperial College London to form the UK's first Academic Health Science Centre. From the report: A new type of drug could alleviate pain in a similar way to cannabis... more
-
-
Stories of children's deaths do not shock India too much. Over 2.1 million kids die every year in the country before they reach the ripe age of five, according to a count by the United Nations Children's Fund (UNICEF) in its State of the World's Children 2008 report. The fate of 49 babies, however, fell in a different category.
They died during clinical trials at New Delhi's All-India Institute of Medical Sciences (AIIMS), which it is obligatory for the nation's media to describe as either "premier" or "prestigious," during the last two and a half years. The institute parted with this news in response to a query from a non-profit organization that sought it under a recently enacted law investing the citizen with a "right to information."
The AIIMS pediatrics department conducted 42 sets of trials on 4,142 babies - 2,728 of them below the age of one - since January 1, 2006. As if to soften the impact of the information, the institute added that the deaths amounted to a 1.18 percent mortality rate.
The belated announcement of the unmourned baby deaths has brought to light a major issue that sections of the media and the middle class - busy hailing India's "economic boom" - have preferred to ignore. Can they continue to evade the issue of the outsourcing of clinical trials of drugs and therapies by the US and other Western pharma giants and the outrageous health and human costs of such operations?
The man who has made it a public issue minces no words about the meaning of the cradle deaths - the guinea-pig role reserved for the country's poor in the scheme of things of the elite set on making India a glittering "economic power." Rahul Verma, founder of New Delhi-based Uday Foundation for Congenital Defects and Rare Blood Groups, reiterates that he and his foundation were mainly concerned about the "socioeconomic conditions" of the strata that provided the tender subjects of the clinical trials.
The AIIMS did not answer his question on this count, but Verma points out that the poor of India alone could be tempted by the trials as they could not afford private medical care, while public heath care was in a pathetic state. The institute provided no information about the reasons for the babies' deaths, their ages or their gender, since he had not specifically asked for it.
Talking on the telephone to Truthout, Verma confided that he had named his foundation after his son Uday, suffering from congenital defects and undergoing surgical treatment since his birth just two an a half years ago. "You can watch your father die, but not your child die," said Verma. He cannot watch the children of the poor die, either, only to save research and development costs for some of the world's richest merchants in medicare.
Verma finds particularly "scary" the fact that such a big proportion of the babies were under one year old. It troubles many medical practitioners that the trials of at least two of the drugs involved should be conducted on even the age group of one to 16 years. The drugs - olmesartan and valsartan, meant for reducing blood pressure - have never been tried on patients below age 18, according to Chandra M. Gulhati, editor of the Monthly Index of Medical Specialties.
In a media interview, he asks: "Is hypertension in this age group a problem in India? If yes, what is the incidence and prevalence? If it is not a major problem, why conduct a trial in India and put children at risk without any benefit?"
The AIIMS tragedy has also raised questions afresh about the official moves afoot to make such clinical trials even easier and more common than ever - all as a part, of course, of an Indian economic miracle in the making. Powerful lobbies for local industry have long pleaded for steps to liberalize the trials, arguing that the country's earnings from them could increase tenfold if annoying obstacles were out of the way. The plea has not gone unheeded.***continues***Stories of children's deaths do not shock India too much. Over 2.1 million kids... more
-
-
'Friendly bacteria' yoghurt products such as Yakult are facing scrutiny from health authorities after 24 patients died during clinical trials of the probiotics. Researchers at the University Medical Centre in Utrecht have admitted that the trial volunteers died between 2004 and 2007 during a study on whether probiotics affected inflammation of the pancreas in 296 people. A spokesman added that the patients 'received the bacteria directly into the intestine via a tube'.'Friendly bacteria' yoghurt products such as Yakult are facing scrutiny from... more
-
