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Archive for June, 2009

Responses to NYT Cancer Research/Money Article

Icon Written by Alex on June 30, 2009 – 9:28 am

The letters regarding Gina Kolata’s article in the New York Times Sunday about how grant funding directs a lot of cancer research and engenders an atmosphere of playing it safe in clinical trials are fascinating.

Almost everyone who wrote and is in the “cancer research” field appears to agree with the findings in the article. It begs the question of course: Why are these same people not working to change the atmosphere?…



Cancer research driven by grant system and safe thinking – June 29, 2009

Icon Written by Alex on June 29, 2009 – 10:32 am

An excellent article in the New York Times by the always astute and well-informed medical and health writer Gina Kolata sheds light on how cancer research is driven by a grant system that rewards cautious thinking more than promoting bold ideas of how to cure and treat cancer. The article is a nice look at a portion of the “medical industrial complex” that appears to be a self-sustaining enterprise and an embedded part of how health care and research are conducted in the United States.

In a related story …

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Michael Jackson Death – Clinical Trials Show There Was Little Hope

Icon Written by Alex on June 26, 2009 – 3:04 pm

The death of Michael Jackson from what appears to be sudden cardiac arrest could probably not have not been prevented if a home automated external defibrillator (AED) had been applied to revive his heart rather than simply receiving CPR. Keep this in mind in the next few days as you hear more and more medical professionals give opinions about how his death might have been prevented: A home defibrillator in all likelihood would not have saved Michael Jackson if he suffered from sudden cardiac arrest.

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Cystic fibrosis and a bill to fast track trials could present problems – June 26, 2009

Icon Written by Alex on June 26, 2009 – 10:05 am

Legislation making it easier for people with rare diseases to enroll in clinical trials – chiefly by removing restrictions to government health benefits such as SSI if they do so – is making its way through Congress. The bill, called the “Improve Access to Clinical Trials Act” is co-sponsored by Representatives Edward J. Markey (D-MA) and Cliff Stearns (R-FL) and 30 members of the House of Representatives. The bill is specifically aimed at boosting enrollment in trials testing new treatments for cystic fibrosis, a condition that affects 30,000 people in the U.S. The long term effects of actual legislation to increase enrollment in trials are unknown. It might be, and I have a feeling it will be, the start of slippery slope that makes enrollment of ever more subjects in trials an easier and less regulated process. Fast tracking trials is risky. Having the government endorse such practices could prove disastrous. I hope I’m wrong and we’ll keep an eye on how this proceeds in the coming weeks and months…

Children’s in cystic fibrosis trial test – Bizjournals.com – Charlotte, NC, USA – Vertex will conduct three different clinical trials as part of the registration program for the drug involving approximately 110 sites … See all stories on this topic

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Clinical Trials Scams, Heroes and Hope – June 23, 2009

Icon Written by Alex on June 23, 2009 – 9:39 am

There’s a fascinating mix of stories in the news today… an Indonesian doctor who has settled in Providence, Rhode Island was inspired by cowboy movies to work in clinical trials trying to cure sepsis, the 10th leading killer in the U.S. … a “doctor” in Clearwater, Florida meanwhile was dispensing pills and exams as part of a clinical trial – the only problem is that he isn’t licensed to practice medicine in the United States – which begs the questions, “Do you have to be an actual doctor to work a clinical trial if the protocol doesn’t specifically state that?” Hmmm … In Ireland doctors are hailing the arrival of clinical trials to study breast cancer treatments as a step forward in helping patients combat the disease, which alone raises serious questions about how trials are regarded in the Irish medical community … Oh, I will be interviewed later today about Chasing Medical Miracles by Celeste Quinn on the Afternoon Magazine show for Illinois Public Media. Here’s a link to the show – http://will.illinois.edu/afternoonmagazine/ – and I will also post one directly to the interview tomorrow.

Movies lured him to US; now he’s corralling a killer – Providence Journal – Providence, RI, USA – By G. Wayne Miller Dr. Yow-Pin Lim has received federal authorization to begin human clinical trials of a drug developed by his company to treat sepsis … See all stories on this topic

Clearwater man accused of posing as doctor – Tampa Tribune – Tampa, FL, USA – One woman who had been diagnosed with a degenerating disk found the office after searching on the Internet in October 2007 for clinical trials involving … See all stories on this topic

Clinical trials ‘benefit’ patients – Irish Times – Dublin, Ireland – HEALTH NEWS: MANY IRISH breast cancer patients are benefiting from being able to join clinical trials that were not available in this country before … See all stories on this topic

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Zicam, the FDA, and Clinical Trials

Icon Written by Alex on June 18, 2009 – 10:12 am

The homeopathic nasal gel and swabs for cold relief symptoms, Zicam, has been slapped with an FDA warning that its use can cause people to lose their sense of smell. Shipment of the products have been halted by the manufacturer after 130 reports of people losing their sense of smell, perhaps some permanently. There has been no recall. Questions being asked in light of the FDA warning is: Why didn’t clinical trials reveal that Zicam has this side effect before the product was marketed? Did Zicam’s manufacturer, Matrixx Initiatives, Inc., know its product caused anosmia, the medical term for loss of the sense of smell? Here are a few clarifications on the issue of clinical trials and Zicam:

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Does anyone here know how to play this game? – Clinical Trials Update – June 17, 2009

Icon Written by Alex on June 17, 2009 – 9:41 am

With indictments against executives at two companies for conducting unauthorized clinical trials and with another trial voluntarily halted by a major university, Emory, because of poor record-keeping discovered after an audit, it’s interesting to see that the National Cancer Institute’s Cancer Bulletin has an article advocating for a more streamlined clinical trials system to increase enrollment of subjects, at least in cancer trials… The apparent focus on recruitment as the first priority and on reducing regulatory oversight as the second priority of many institutions that conduct or sponsor trials is disturbing. In the words of Casey Stengel, “Doesn’t anyone here know how to play this game?”…

Norian, Synthes, executives charged with conducting medical trials … Bizjournals.com – Charlotte, NC, USA – The indictment charges that from May 2002 until fall 2004 Norian conspired with others, including Synthes, to conduct unauthorized clinical trials of two …See all stories on this topic

A Closer Look: A Sense of Urgency: Rethinking the Clinical Trial … National Cancer Institute – NCI Cancer Bulletin – Bethesda, MD, USA – Low enrollment of adult cancer patients in clinical trials is an ongoing challenge in cancer research. Only about 3 to 5 percent of adults diagnosed with … See all stories on this topic

Emory halts enrollment in cancer clinical trials – Atlanta Journal Constitution – GA, USA – By Craig Schneider – Emory University’s Winship Cancer Institute has stopped accepting new patients into clinical trials after a critical audit … See all stories on this topic

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Strange new legislation and corruption in clinical trials – June 16, 2009

Icon Written by Alex on June 16, 2009 – 9:51 am

A new piece of legislation in the U.S. House aims to increase clinical trials participation by allowing patients with rare diseases to become subjects in trials and not lose their government health insurance. The move is applauded by the Cystic Fibrosis Foundation as a new way to get medications from the research stage into the “hands of people who need them.” This is worth watching long term to see what the implications of this kind of fast-tracking is for drug development and for subjects and patients…. also, the FDA is putting tighter warnings on some asthma drugs because test facilities where some went through trials were not at all to up to par… All this plus industry news is in today’s update which you can read below…

New Legislation Seeks to Boost Participation in Clinical Trials … PR Newswire (press release) – New York, NY, USA – The “Improve Access to Clinical Trials Act” is co-sponsored by Representatives Edward J. Markey (D-MA) and Cliff Stearns (R-FL) and 30 members of the House … See all stories on this topic

FDA Move on Asthma Drug Warnings Comes After Complaints About … BNET – San Francisco, Ca, USA – The brazen “study buddy” and “crossover” arrangements, as staff referred to them, included churning or serially enrolling patients into clinical trials … See all stories on this topic

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Registration of Clinical Trials in India and other news… June 15, 2009

Icon Written by Alex on June 15, 2009 – 9:03 am

India has taken a big step toward making their clinical trials more public and open… also an interesting story out of Australia regarding microbicide trials for an HIV vaccine – the kind conducted in Uganda… plus the book Chasing Medical Miracles is out in wide distribution so go buy a copy! Also, for comprehensive information on trials for pay, please visit Paul Clough’s excellent and popular site Just another Lab Rat at http://www.jalr.org.

Now, all human clinical trials to be registered – Times of India – India – BANGALORE: In a significant move aimed at making clinical trials on human beings more ethical and transparent, the Drugs Controller of India has ruled for … See all stories on this topic

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Swine Flu Vaccine in Clinical Trials

Icon Written by Alex on June 13, 2009 – 11:11 am

This is a great example of the positive power of clinical trials… A vaccine for swine flu – which the World Health Organization has recently deemed a worldwide pandemic – is being tested in clinical trials by Swiss pharmaceutical company Novartis. If things go well, the vaccine could be available for use in four months. Other great news today is about the success of a potential cancer vaccine as well as improvements for a gout treatment…

AFP – Swine flu vaccine ready for clinical trials – AFP – Swiss drugs firm Novartis says it has completed a first batch of vaccine for pre-clinical trials and aims to make a version available in about four months. … See all stories on this topic

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