Tag: Clinical trial

  • Indian School Conducts Clinical Trials On Children

    We know that foreign Pharma companies conducting clinical trials of new drugs in India with out the Governments’s approval.

    But for a School to conduct this with out permission from the authorities in unthinkable.

    To make it prim and proper the school sends out a circular that it is Voluntary!

    What an arrogance!

    Story:

    A school in Bangalore wants its children in the 6-9 age group to be part of a “clinical trial” that a student of its sister institution is conducting.

    The Oxford English School (CISCE), JP Nagar, has sent a letter to parents. In the letter (a copy of which is with TOI), the school has said: “A first-year student of our Oxford Dental College and Hospital, pursuing his MDS, has taken up as part of his dissertation for the topic, ‘Comparison of retention of favourable composite resin and conventional resin based sealant’, which involves as randomized control trial of the patient with 18 months’ follow-up. This exercise is aimed at students of ages 6 to 9 (classes one to four) and is totally free.”

    Signed by school principal Alistair M Laporte, the letter further says: “If there is a problem, a follow-up will be taken (up) by him, which will involve placement of cement, without drilling or cutting.” The circular asked parents to send their consent by January 17 and all students were informed by their respective class teachers.

    http://timesofindia.indiatimes.com/city/bangalore/Clinical-trial-on-children-kicks-up-big-row/articleshow/18108587.cms

     

  • All purpose Cancer Vaccine Developed.

    There have been so many claims over the years that I would take this with a pinch of salt.

    The Human Body -- Cancer
    The Human Body — Cancer (Photo credit: n0cturbulous)

    Source.

    A vaccine that can train cancer patients‘ own bodies to seek out and destroy tumour cells has been developed by scientists.

    The therapy, which targets a molecule found in 90 per cent of all cancers, could provide a universal injection that allows patients’ immune systems to fight off common cancers including breast and prostate cancer.

    Preliminary results from early clinical trials have shown the vaccine can trigger an immune response in patients and reduce levels of disease.

    The scientists behind the vaccine now hope to conduct larger trials in patients to prove it can be effective against a range of different cancers.

    They believe it could be used to combat small tumours if they are detected early enough or to help prevent the return and spread of disease in patients who have undergone other forms of treatment such as surgery.

    Cancer cells usually evade patient‘s immune systems because they are not recognised as being a threat. While the immune system usually attacks foreign cells such as bacteria, tumours are formed of the patient’s own cells that have malfunctioned.

    Scientists have, however, found that a molecule called MUC1, which is found in high amounts on the surface of cancer cells, can be used to help the immune system detect tumours.

    The new vaccine, developed by drug company Vaxil Biotheraputics along with researchers at Tel Aviv University, uses a small section of the molecule to prime the immune system so that it can identify and destroy cancer cells.

    A statement from Vaxil Biotheraputics said: “ImMucin generated a robust and specific immune response in all patients which was observed after only 2-4 doses of the vaccine out of a maximum of 12 doses.

    “In some of the patients, preliminary signs of clinical efficacy were observed.”

    The results are still to be formally published but if further trials prove to be successful the vaccine could be available within six years.

    As a therapeutic vaccine it is designed to be given to patients who are already suffering from cancer to help their bodies fight off the disease rather than to prevent disease in the first place.

    Cancer cells contain high levels of MUC1 as it is thought to be involved helping tumours grow. Healthy human cells also contain MUC1, but have levels that are too low to trigger the immune system after vaccination.

    When a vaccinated patient’s immune system encounters cancer cells, however, the far larger concentration of MUC1 causes it to attack and kill the tumour.

    http://digg.com/newsbar/topnews/universal_cancer_vaccine_developed_telegraph

  • Vitamin Pills Unnecessary-Researchers.

    All growth oriented products are good for the health of the manufacturers.

    None of the vitamin pills are effective .

    Only way to supplement Vitamin loss is to eat the vegetables/foods that contain the vitamins.

    It is also a fact that if a pill for a particular deficiency is taken, it is ejected in stools.

    For instance if you take iron tablets you will find your stools greenish, which is iron being thrown out.

    if you tale B Complex, it gets thrown out in urine, which will be yellow.

    Medicine is driven by Drug Companies and crooked Doctors..

    Physicians have recommended vitamin D supplements to their patients for a decade, with good reason: dozens of studies have shown a correlation between high intake of vitamin D—far higher than most people would get in a typical diet and from exposure to the sun—and lower rates of chronic diseases, such as cancer and type 1 diabetes. So when the Institute of Medicine, which advises the government on health policy, concluded in November that vitamin D supplements were unnecessary for most Americans and potentially harmful, patients were understandably confused.

    The issue exposes a rift among experts over what constitutes valid proof when it comes to nutrition and could affect medical advice on many other supplements. On the one hand are scientists who insist that the only acceptable standard is the randomized clinical trial, which often compares the effects of a medical intervention, such as high intake of vitamin D, with those of a placebo. The scientists who reviewed the vitamin D findings fall heavily into this camp: trials “typically provide the highest level of scientific evidence relevant for dietary reference intake development,” they wrote. Their report set intake levels based only on clinical trial data.

    The institute panel, however, discarded a raft of observational studies, in which researchers compare the health of populations who take vitamin D supplements with those who do not. In theory, such epidemiological studies are inferior to clinical studies because they rely on observations out in the real world, where it is impossible to control for the variables scientists seek to understand. Researchers compensate for the lack of control by using large sample sizes—some vitamin D studies track 50,000 people—and applying statistical techniques. According to these studies, high levels of vitamin D are generally beneficial.

    In the aftermath of the institute report, some physicians are now taking potshots at clinical studies. In nutrition, they say, true placebo groups are hard to maintain—how do you prevent people in a control group from, say, picking up extra vitamin D from sunlight and food, which can lead to underestimating the vitamin’s benefits? It is also tough to single out the effect of one vitamin or mineral from others, because many work in tandem. “It is wrong-headed thinking that the only kind of evidence that is reliable is a randomized controlled trial,” says Jeffrey Blumberg, a Tufts University pharmacologist.

    http://www.scientificamerican.com/article.cfm?id=which-pills-work&WT.mc_id=SA_CAT_BS_20110211

     

  • How Drug Companies manipulate Doctors(some take part)?

    Newspaper advertisements seeking patients and ...
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    Please read some of my Blogs on Health.

    Story:

    Bias #1: Unwanted Results are Not Published

    In order for scientific studies to happen, someone has to pay for them.

    The top funder for any drug trial is the pharmaceutical company that makes it, since the manufacturer is most invested in “proving” how spectacular its drug is. Dr. Golomb uses the case of statins as an example, stating that all of the major statin studies have been funded exclusively by the drug industry.

    The second-highest funder of drug studies is the National Institute of Health (NIH), which is not the group of neutral government experts you may have assumed them to be. In fact, NIH accepts a great deal of money from Big Pharma and is deeply enmeshed with the industry.

    But drug companies publish only a fraction of the studies they fund — the ones that promote their drugs.

    If a study does not have findings that are favorable to its product, it is unlikely it will ever make it into a journal for publication.

    In contrast, studies that have favorable findings almost always make the cut.

    There are simply thousands of scientific studies out there that have never been seen by you or your physician because they have been screened out by editors and reviewers who are being paid to uphold an industry agenda.

    Published studies overwhelmingly favor the funding company’s drug. Whichever drug is manufactured by the study sponsor is the drug that comes out on top, 90 percent of the time!

    Given this, how can medical journals be considered unbiased?

    Bias #2: Bad Results are Submitted as Good

    When a scientific study has findings that cast doubt on the efficacy of a drug, oftentimes the negative findings are morphed into positive ones.

    For example, in 2008, FDA officials analyzed a registry of 74 antidepressant trials, which included trials that were published and those that were not. The FDA’s findings were then written up in an article in the New England Journal of Medicine1.

    This is what they found:

    • 38 of the trials reported positive results, and 37 of the 38 were published.
    • 36 trials had negative or questionable findings. Of the 36, 22 were not published at all, and 11 were published in a way that conveyed the results as though they were positive.

    So, if you just went to the published literature, it would look like 94 percent of the studies were positive, when in reality only about 50 percent were positive … equivalent to a coin toss.

    For statins, the odds that the funding company’s drug will come out on top are staggering1:

    • The odds that the funding company’s statin drug will come out looking better than anyone else’s statin in the “results” section of the article are 20:1.
    • The odds that the funding company’s statin will come out on top in the “conclusions” part of the article are 35:1.

    So, even if they can’t make the results look good, they can often find a way to twist the conclusions so that their drug appears favorable.

    Selectively omitting negative trial results can be devastating to your health, as Merck & Co. proved when they concealed the fact that three patients suffered heart attacks from Vioxx during clinical trials. They conveniently omitted this data (along with other relevant findings) from the copy of the study they submitted to the New England Journal of Medicine for publication.

    The omissions were uncovered years later during the 7,000 Vioxx lawsuit litigations.

    Bias #3: A Favorable Study is Submitted Multiple Times

    When a study yields positive results, it is often submitted multiple times in a way that the reader doesn’t realize it’s the same study, obscured by different author lists and different details. Analyzers have had to look very carefully to determine which studies are actually duplicates because they are so cleverly disguised.

    Not surprisingly, trials reporting greater treatment efficacy were significantly more likely to be duplicated, according to Dr. Golomb’s reporting.

    In one analysis of the published reports about ondansetron (an anti-nausea drug), the same study was published 5 times. This duplication of data led to a 23 percent overestimation of ondansetron’s effectiveness when a meta-analysis was performed.2

    Talk about good mileage!

    Bias #4: Follow-Up Reviews Done by Biased Experts

    The editorials that follow from a study, submitted by so-called unbiased experts and then published in reputable journals, are often done by non-neutral parties who have a financial tie to the drug maker.

    Dr. Golomb uses the case of calcium channel blockers (a type of heart medication) as an example. The connection between authors declaring their support for calcium channel blockers and those not in support of them was highly statistically tied to their affiliation with the drug manufacturer — in fact, the odds that their opinion was NOT due to their affiliation was more than 1,000:1.

    Bias #5: Ghostwriting

    Many of the articles that appear in medical journals purportedly written by well-known academics are actually written by unacknowledged ghostwriters on Big Pharma payroll.

    Consider the example of Parke-Davis and their drug Neurontin.

    Parke-Davis contracted with a “medical education communication company,” or MECC, which is a company paid almost exclusively by pharmaceutical companies to write articles, reviews, and letters to editors of medical journals to cast their products in a favorable light.

    In this case, MECC was paid $13,000 to $18,000 per article. In turn, MECC paid $1,000 each to friendly physicians and pharmacists to sign off as authors of the articles, making the material appear independent.

    This was also done by Pfizer as a strategy for marketing Zoloft. A document was written that included 81 different articles promoting Zoloft’s usefulness for everything from panic disorder to pedophilia.

    The only problem was, for some articles, the name of the author was listed as “to be determined,” even though the article was listed as already completed. They weren’t helping out an existing team of scientists who happened to be talentless at writing — Pfizer wrote the article, and then shopped around for scientists willing to claim authorship, to give it a veneer of credibility.

    Wyeth-Ayerst employed a similar ghostwriting tactic to promote its “fen-phen” diet drug, Redux.

    Bias #6: Journal Bias

    Medical journals are generally considered by medical practitioners to be a source of reliable information. But medical journals are also businesses.

    Three editors, who agreed to discuss finances only if they remained anonymous, said a few journals that previously measured annual profits in the tens of thousands of dollars now make millions annually.

    The truth is that Big Pharma has become quite adept at manipulating and brainwashing practitioners of conventional medicine. They influence the very heart and center of the most respected medical journals, creating dogma and beliefs that support the drug paradigm because it is blessed by the pinnacle of scientific integrity: the prestigious peer-reviewed medical journal.

    Peer-reviewed medical journals contain advertisements that are almost exclusively for drugs, amidst articles that are biased toward promoting those drugs. If you have looked through a medical journal lately, you’ll see full-page Pharma glossies, cover to cover.

    Pharmaceutical companies spend almost twice as much on marketing as they spend on research!

    In 2003, drug companies spent $448 million dollars on advertising in medical journals2. It has been calculated that the return on investment on medical journal ads is between $2.22 and $6.86 for every dollar spent, with larger and older brands at the higher end.

    Long-term returns may be even higher when you consider that one ad viewed by a physician could result in hundreds or even thousands of drug purchases, based on the prescriptions he or she writes.

    The term “peer-review” has come to imply scientific credibility. But the fact is that many of the peer-reviewers are on the drug company’s payroll, and those who are not are unlikely to detect flawed research or outright fraud.

    Medical journals are the number one source of medical information for physicians. In fact, nearly 80 percent of physicians use medical journals for their education, which exceeds information from any other source3.

    Do you really want to blindly take the advise of a physician whose only source of medical information is a medical journal engaged in such profound conflicts of interest?

    Advertisements for drugs focus the “latest and greatest” drugs to hit the market, drugs which may not be superior to existing, less expensive alternatives. So physicians are seduced into prescribing the newest, most expensive drugs, which drives up your healthcare costs.

    An excellent article in PLoS Medicine regarding drug advertising in medical journals concludes4:

    “The scholarly nature of journals confers credibility on both articles and advertisements within their pages. By exclusively featuring advertisements for drugs and devices, medical journals implicitly endorse corporate promotion of the most profitable products. Advertisements and other financial arrangements with pharmaceutical companies compromise the objectivity of journals.

    The primary obligation of industry is to make money for its stockholders. The primary obligation of journals should be to physicians and their patients, who depend on the accuracy of information within these publications. Medical journals should not accept advertisements from pharmaceutical companies, medical device companies, or other industries ‘relevant to medicine.’”

    In 2004, Dr. Richard Horton, editor of the Lancet, wrote, “Journals have devolved into information-laundering operations for the pharmaceutical industry.”5

    Bias #7: Drug Companies Masquerading as Educators

    The education of medical students and residents also comes through the filter of the drug industry, which seeks to groom them before they even finish medical school.

    According to Dr. Golomb’s data, Big Pharma now spends $18.5 billion per year promoting their drugs to physicians. That amounts to $30,000 per year for every physician in the U. S.!

    And drug companies are allowed to develop their own education curriculum for medical students and residents, lavishing them with gifts, indirectly paying them to attend meetings and events where they promote the company’s products.

    Why is the Accrediting Commission for Continuing Medical Education (ACCME) so permissive with industry involvement?

    Almost half of the members are representatives of Big Pharma or are consultants for businesses that work directly with it to prepare these educational programs. Only a few represent academic CME institutions.

    Any discussion of physician “seduction” would be incomplete without the mentioning of the 100,000 drug reps, who are groomed and trained to wine and dine and otherwise shower physicians in sweetness until they are handing out prescriptions like candy.

    Reps are even taught tactics for manipulating doctors for industry benefit, as a standard part of their training.6

    Hell Hath No Fury

    What happens if a physician or other person speaks up about these conflicts of interest? What happens to the proverbial whistle-blower?

    Intimidating phone calls and direct threats, for starters.

    In one case, Dr. Buse, an endocrinologist who is the incoming president of the American Diabetes Association, presented data in 1999 about his concerns about the risks of Avandia. Dr. Buse was intimidated with multiple phone calls by drug company officials. They suggested he could be financially liable to the company for $4 billion in lost revenues due to his “unscrupulous remarks.”

    Other truth-tellers have had their reputations trashed or job offers rescinded for speaking the truths that Big Pharma works so hard to keep under wraps.

    “Too Big to Nail”

    An individual truth-teller might be vulnerable to the wrath of an angry drug company, but drug companies are unlikely to suffer much of a consequence for their crimes.

    A CNN report from April 2, 2010 reveals the truth about how shielded these huge drug companies really are.

    Pfizer, the world’s largest pharmaceutical company, engaged in illegally promoting their drug Bextra for off-label use, despite their knowledge that it was associated with an increased risk of stroke and heart attack.

    Bextra was pulled from the market in 2005, but not before many people were damaged by its use. When Federal prosecutors realized that convicting Pfizer would likely be a corporate death sentence (as any company convicted of major health care fraud is excluded from Medicare and Medicaid), they cut Pfizer a deal. Just as the big banks on Wall Street were deemed “too big to fail,” Pfizer was deemed “too big to nail.”

    Why?

    Prosecutors claimed to be concerned about the loss of jobs by Pfizer employees and financial losses to Pfizer shareholders as a result of being excluded from the Medicaid/Medicare programs.

    So the prosecutors charged a Pfizer subsidiary, Pharmacia & Upjohn Co., instead. In fact, this particular subsidiary company was created specifically for this purpose, as a sacrificial lamb, having been incorporated the very same day its lawyers filed a “guilty” plea in another case involving kick-backs, leaving Pfizer with the penalty equivalent of being sent to bed without supper.

    In the end, all Pfizer lost was about three month’s profit, but all contracts, including those with Medicaid and Medicare, were spared.

    This is just one more example of your federal government failing to protect you, and opting to protect big business’ interests instead.

    The bottom line is, the drug companies aren’t going to protect you.

    The government won’t protect you.

    The AMA won’t protect you.7

    And it is unlikely that your physician can protect you either — even a well-meaning one — when he or she is operating within a system that has become RIGGED for Big Pharma profit.

    Only you can protect yourself.

    So, until real systemic change takes place, your best health strategy is quite simply to employ and maintain a naturally healthy lifestyle that will optimize your body’s innate healing abilities and minimize your need for the drug companies’ latest concoctions.

    Sources:

    Chicago Breaking News Center April 8, 2010

    http://articles.mercola.com/sites/articles/archive/2010/05/18/how-corrupted-drug-companies-deceive-and-manipulate-your-doctor.aspx

    Related;

    Five out of six approved prescription drugs seldom benefit patients, says a critic of the pharmacy industry. The 6th one works just because big pharma says it does.

    Chloresterol-lowering statins were a conspicuous example of the drugs industry over-hyping a product to avert heart attacks, even though they could do more harm than good, said Donald Light, sociologist and professor of comparative health policy at the University of Medicine and Dentistry in New Jersey, U.S.

    Drug corporates hyped-up patented medicines, spent astronomical sums on getting doctors to prescribe them and underplayed serious side-effects, reports the Telegraph.

    http://truthonmedecine.wordpress.com/2010/12/21/5-out-of-6-new-drugs-dont-work/

     

  • Many Dialysis Patients Undergoing PCI Receive Improper Medication, With Higher Risk of Bleeding

    ScienceDaily (Dec. 11, 2009) — Approximately 20 percent of dialysis patients undergoing a percutaneous coronary intervention (PCI; procedure such as angioplasty) are given an antithrombotic medication they should not receive, which may increase their risk for in-hospital bleeding, according to a study in the December 9 issue of JAMA.
    See Also:

    “In the United States, medication errors are implicated in more than 100,000 deaths annually. Medication errors include adverse drug reactions related to inappropriately prescribed or administered drugs. To minimize inappropriate medication use, the U.S. Food and Drug Administration (FDA) guides pharmaceutical manufacturers and clinicians through drug labeling of which medications are contraindicated or not recommended for use in specific patient groups,” the authors write. “Little is known about the use of such medications and their effects on outcomes in clinical practice.”
    Thomas T. Tsai, M.D., M.Sc., of the Denver VA Medical Center and University of Colorado Denver, and colleagues examined the use of the contraindicated/not-recommended antithrombotic agents enoxaparin and eptifibatide among dialysis patients undergoing percutaneous coronary intervention (PCI) and their association with outcomes. The researchers used data from the National Cardiovascular Data Registry (NCDR) from 829 U.S. hospitals on 22,778 dialysis patients who underwent PCI between Jan. 2004 and August 2008. The study focused on the outcomes of in-hospital bleeding and death.
    The researchers found that overall, 5,084 patients (22.3 percent) received a contraindicated antithrombotic medication; 2,375 (46.7 percent) received enoxaparin, 3,261 (64.1 percent) received eptifibatide, and 552 (10.9 percent) received both. In unadjusted analysis, patients who received contraindicated antithrombotics experienced higher rates of in-hospital major bleeding (5.6 percent vs. 2.9 percent) and death (6.5 percent vs. 3.9 percent). Further analysis indicated that receipt of contraindicated antithrombotics was significantly associated with increased in-hospital major bleeding, but no significant association was found with in-hospital death.
    “This study therefore demonstrates that these medications are used in clinical practice despite FDA-directed labeling, and their use is associated with adverse patient outcomes,” the authors write.
    “Educational efforts targeting clinicians who prescribe these medications and quality improvement interventions, such as amending clinical pathway order sets to include consideration of renal function, are urgently needed.”