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Archive for the ‘clinical trials’ Category

Swine flu vaccine, cancer & “rigged” trials – July 15, 2009

Icon Written by Alex on July 15, 2009 – 8:34 am

A vaccine for swine flu is nearing clinical trials testing while at the same time the U.S. is pumping another $1 billion into the vaccine to get it to trials, perhaps this month… A Denver television news station (of all places) has a very interesting story on a report released from watchdog organization Public Citizen saying that a large number of clinical trials results are not accurate because money plays to big an influence in trials… An examination of cancer trials reveals that race plays a part in the rates among African Americans in some significant cancers… all in all, interesting reading for a beautiful Wednesday…

Labs say swine flu vaccine is close to clinical trials – guardian.co.uk – UK – Some are in the experimental stages, while others are approaching the need for clinical trials. However they are “by no means” ready yet, according to the …

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Clinical trials business booming and stem cell trials heating up – July 7, 2009

Icon Written by Alex on July 7, 2009 – 3:16 pm

Despite economic hard times more clinical trials were initiated in 2008 than the previous year, boding well for the industry to weather the recession. Perhaps helping keep the industry active in the coming months and years is an increase in stem cell trials overseas after the U.S. government changed policy and allowed federal fund to be used for the research. All this and a look at how trials results from China are being called into question plus lots more in today’s news…

Clinical research activity up significantly in 2008 – WTN News – Madison,WI,USA – Despite cutbacks in the international biopharma industry, clinical trial activity was up in 2008. Overall, 795 new clinical trials were launched in 2008 … See all stories on this topic

Policy Shift On Stem Cell Research May Produce Effect Overseas – Life Science Leader Magazine – Erie, PA, USA – A total of 2147 clinical trials (Phase I-IV) for stem cell therapies overall were listed, as of June, on NIH’s website: www.ClinicalTrials.gov … See all stories on this topic

Randomized trials published in some Chinese journals: how many are …

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Clinical Trials Good News & Bad News: Pfizer, Stem Cells & Doubt – July 3, 2009

Icon Written by Alex on July 3, 2009 – 9:42 am

The Good News: The first clinical trial for healing an injured heart by using a subject’s own stem cells is underway. Pfizer proactively and voluntarily halted a trial after results showed it was to likely to be successful.

The Bad News: The validity of clinical trials conducted China is under scrutiny because of too many positive results. A columnist says some trials may be rushed and done poorly to get drugs to market quickly.

All in all, another normal day of mixed news about whether trials are mostly helping or harming. Here’s to hoping that on this July 4 eve we start moving in a direction where there’s more good news than bad news for the American people and the global community.

Doubts Cast On Credibility Of Some Published Clinical Trials – Science Daily (press release) – USA- However, all RCTs of pre-market drug clinical trial were authentic, and RCTs conducted at hospitals affiliated with medical universities were more likely to …

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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?…



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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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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Clinical Trials Update – June 11, 2009

Icon Written by Alex on June 11, 2009 – 9:42 am

Clinical trials are starting on a malaria vaccine. The importance of this research cannot be overstated. More than perhaps any other disease in human history, malaria has killed millions – including one million just last year — decimated millions of other lives, and hampered the full development of Africa. This is a great step in a new direction to eradicating this killer. Let’s see what happens as things progress…

African Clinical Trial Begins for Malaria Vaccine – DOTmed.com (press release) – New York, NY, USA – Researchers have started a major clinical trial in Africa of what is hoped to be the world’s first vaccine against malaria. … See all stories on this topic