Human papillomavirus infection is the cause of nearly all cases of cervical cancer, and so immunizing young women before they are exposed to the virus could save a great many lives. So, the idea of a large scale clinical trial of an HPV vaccine in India seems like a valid idea, based on the country's supposed huge cervical cancer healthcare burden. Not so--according to a paper published in the Journal of the Royal Society of Medicine, the epidemiology behind the study is flawed and the trial is currently the subject of an investigation by the Indian government.The trial was under the auspices of PATH, an international health charity, and included over 23,000 girls in the Indian states of Gujarat and Andhra Pradesh. The charity had claimed that "in raw numbers, India has the largest burden of cancer of the cervix of any country worldwide." However, according to the study, led by Allyson Pollock of Barts and The London Medical School, the cancer surveillance, registration and monitoring in India in general, particularly in the Gujarat and Andhra Pradesh regions, were incomplete, so that it would be impossible to tell whether the vaccine would be successful in preventing the disease.The figures that do exist for India show that there were only 22 cases of cervical cancer per 100,000 in 2004/2005 in india, falling from 43 cases per 100,000 in 1982/1983--this is around half the rate in countries like Brazil and Zimbabwe."This trial has clearly raised serious concerns for the people and government of India," says Pollock. "We found that current data on cervical cancer incidence do not support PATH's claim that India has a large burden of cervical cancer or its decision to roll out the vaccine program."India does have major health burdens, for example in malaria and other infectious diseases, maternal anemia and malnutrition, and so the use of an expensive HPV vaccine, which is one of the more expensive vaccines on the market, for a health issue with a lower impact would seem to be a flawed use of limited financial resources.- read the press release
- see the paperRelated Articles:
GAVI Alliance could be closer to HPV vax deal
Gardasil could cut cancer in women already infected with HPV
Study: Most girls who get HPV vax say they see need to practice safe sex read more..
Friday, 22 June 2012
Government Of India-Cervical Cancer-Clinical Trial-Andhra Pradesh-Hpv Vaccine
Monday, 4 June 2012
Journal Of Clinical Psychopharmacology-Veterans Affairs Medical Center-Medical College Of Georgia
Why Are These Fraudulent Papers Unretracted?
According to Science Times[1], the Tuesday science section in the New York Times, scientific retractions are on the rise because of a “dysfunctional scientific climate” that has created a “winner-take-all game with perverse incentives that lead scientists to cut corners and, in some cases, commit acts of misconduct.”
But elsewhere, audacious, falsified research stands unretracted–including the work of authors who actually went to prison for fraud!
Richard Borison, MD, former psychiatry chief at the Augusta Veterans Affairs medical center and Medical College of Georgia, was sentenced to 15 years in prison for a $10 million clinical trial fraud[2] but his 1996 US Seroquel® Study Group research is unretracted.[3] In fact, it is cited in 173 works and medical textbooks, misleading future medical professionals.[4]
Scott Reuben, MD, the “Bernie Madoff” of medicine who published research on clinical trials that never existed, was sentenced to six months in prison in 2010.[5] But his “research” on popular pain killers like Celebrex and Lyrica is unretracted.[6] If going to prison for research fraud is not enough reason for retraction, what is?
Wayne MacFadden, MD, resigned as US medical director for Seroquel in 2006, after sexual affairs with two coworker women researchers surfaced[7], but the related work is unretracted and was even part of Seroquel’s FDA approval package for bipolar disorder.[8]
More than 50 ghostwritten papers about hormone therapy (HT) written by Pfizer’s marketing firm, Designwrite, ran in medical journals, according to unsealed court documents on the University of California–San Francisco’s Drug Industry Document Archive.[9] Though the papers claimed no link between HT and breast cancer and false cardiac and cognitive benefits and were ghostwritten by marketing professionals not doctors, none has been retracted.
Pfizer/Parke-Davis placed 13 ghostwritten articles[10] in medical journals promoting Neurontin for offlabel uses, including a supplement to the Cleveland Clinic[11] but only Cochrane Database Systematic Reviews and Protocols has retracted the specious articles.[12]
Nor is the phony science just a product of “Big Pharma.” In 2008, JAMA was forced to print a correction stating that authors of an article arguing for a higher recommended dietary allowance of protein were, in fact, industry operatives. [13] Sharon L. Miller was “formerly employed by the National Cattlemen’s Beef Association,” and author Robert R. Wolfe, PhD, received money from the Egg Nutrition Center, the National Dairy Council, the National Pork Board, and the Beef Checkoff through the National Cattlemen’s Beef Association, said the clarification. Miller’s email address, in fact was smiller@beef.org, which should might have been the JAMA editors’ first tip-off.[14] The article has also not been retracted.
Martha Rosenberg’s is an investigative health reporter. Her first book, Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health, has just been released by Prometheus books.
[1] http://www.nytimes.com/2012/04/17/science/rise-in-scientific-journal-retractions-prompts-calls-for-reform.html?_r=1&pagewanted=all
[2] Steve Stecklow and Laura Johannes, “Test Case: Drug Makers Relied on Two Researchers Who Now Await Trial,” Wall Street Journal, August 8, 1997
[3] Richard Borison et al., “ICI 204,636, an Atypical Antipsychotic: Efficacy and Safety in a Multicenter, Placebo-Controlled Trial in Patients with Schizophrenia,” Journal of Clinical Psychopharmacology 16, no. 2 (April 1996): 158–69
[4] Alan F. Schatzberg and Charles B. Nemeroff, Textbook of Psychopharmacology (New York: American Psychiatric Publishing, 2009) p. 609
[5] http://www.scientificamerican.com/article.cfm?id=a-medical-madoff-anesthestesiologist-faked-data
[6] Scott Reuben et al., “The Analgesic Efficacy of Celecoxib, read more..
Thursday, 24 May 2012
Memorial Sloan-Kettering Cancer Center,-American Society Of Clinical Oncology-Initial Chemotherapy
BERKELEY HEIGHTS, N.J., May 22, 2012 (GLOBE NEWSWIRE) -- Genta Incorporated (GNTA) today announced results from the Company's Phase 2 clinical trial using tesetaxel as initial, single-agent chemotherapy in women with advanced breast cancer. The data will be formally presented at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL. Tesetaxel is the leading oral taxane in clinical development. The trial is lead by Memorial Sloan-Kettering Cancer Center, New York, NY, in collaboration with three other U.S. centers. (Source: Medical News (via PRIMEZONE)) read more..
Tuesday, 10 April 2012
Immune Responses-Clinical Trial-Flu Shot-Vaccine
iBio's ($IBIO) shares have jumped 21% with the announcement that it has completed the first Phase I clinical trial of its plant-based vaccine for H1N1 influenza, HAC1. The study of the vaccine, produced by iBio's partner the Fraunhofer USA Center for Molecular Biotechnology, aimed to assess the vaccine's safety, as well as looking for early clues to its ability to trigger an immune response against the flu virus.The study showed that the vaccine was safe and well-tolerated at low and high doses, regardless of whether an adjuvant was used. The vaccine also triggered immune responses, with the best immune response seen in the people who received the highest dose of the vaccine without an adjuvant. This was a similar response to a marketed flu shot.The vaccine's development is supported by funding from the Defense Advanced Research Projects Agency (DARPA). The vaccine is based on iBio's iBioLaunch platform, which uses plants to produce engineered proteins. The researchers are analyzing the data and are preparing a manuscript for a peer-reviewed journal.- read the releaseRelated Articles:
H1N1 provides new universal flu vax hope
Plant-based H1N1 vax starts clinical trial
WHO says H1N1 pandemic has run its course
Up to 70M doses of unused H1N1 vax to be destroyed read more..
Sunday, 8 April 2012
Pfizer Announced Plans-Pfizer, Social Media -Personal Technology-Clinical Trial
Last year, Pfizer announced plans to run the first clinical trial to allow patients to participate from home by using computers and smartphones instead of going to a clinic or doctor’s office. The idea was to create a model for saving money that will rely on personal technology to more easily recruit patients and monitor [...] read more..
Wednesday, 14 March 2012
Clinical Trials-Pharmalot-Pfizer
After Years of Telling Consumers Not to Trust the Internet, Pfizer Discovers that It Cannot Convince Patients to Participate in Internet-based Clinical Trials. Duh!
As reported on Pharmalot (here): "Last year, Pfizer announced plans to run the first clinical trial to allow patients to participate from home by using computers and smartphones instead of going to a clinic or doctor’s office. The idea was to create a model for saving money that will rely on personal technology to more easily recruit patients and monitor their progress. Known as a ‘clinical trial in a box,’ the study is testing the Detrol overactive bladder drug in 10 states and gained an FDA blessing. However, Pfizer ran into some snags winning over patients."
Craig Lipset, Head of Clinical Innovation at Pfizer, explained it this way: "I think some of the staunch advocates for using online and social media for recruitment are still reticent to claim silver bullet status and not use conventional channels in parallel. In terms of health literacy, the patient population is largely unaware of clinical trials and participation. You’re going in at a level where there’s still a lot of basic learning needed for individuals to make informed decisions about whether to participate. And doing that without an interaction with a healthcare provider is a challenge."
I wouldn't say there's a lack of "health literacy" regarding decisions to participate, but more lack of credible information and TRUST, which is what Lipset is talking about in the last two sentences quoted above.
As Lipset admits later on in the interview with Pharmalot:
"In a world where we’ve been telling people not to trust (web) sites online and then to ask them to do everything online is still a challenge. A very important takeaway is that online is great, but make sure these folks know they’re not alone and have a sense of contact that they need… The twist here was to go from awareness to randomized participant entirely online, and this is where ensuring some human contact as well as an optimized online process have proven extremely important."
Is this a case of the "dead rat" coming home to roost? See "Was a Rat Harmed in the Filming of This Pfizer Commercial?" read more..