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

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

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

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

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

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

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

It’s a gorgeous Wednesday morning here in Bisbee. My first book signing is here on on Saturday from 3-6 pm. I am sharpening my pencils for that. I am also sending out promo copies of Chasing Medical Miracles for reviews and coverage of the topic.l If you know of anyone who might want a copy to do a story or review it, please drop me a line.

Nice story below on recruiting subjects for Phase I trials. My own experience with that was so weird. As part of research on the book I enrolled (but did not take part) in an early-phase study of an epilepsy drug. I was loaded up on drugs and barely qualified for any of the criteria set by the company but they called and told me I passed their tests and could be enrolled. There is a definite desperation on behalf of some companies to fill slots and the article on top today, while not specifically about that, gives insight to how clinical trials companies function in their recruitment…

Recruiting and retaining participants in early-phase trials – FiercePharma – Washington, DC, USA – The early-phase clinical trials stage is an exciting but stressful milestone for a compound headed toward market release. Significant effort, resources ..

On the eve of the book’s release, there are some good stories today about the representation – or apparent under representation – of women in clinical trials… fascinating reading. Enjoy!

Too few women in clinical trials? Nature.com (subscription) – London, England, UK – Women are under-represented in cancer studies, according to a survey of clinical research published today. The finding suggests that women are not getting … See all stories on this topic

Women Underrepresented in Cancer Studies – Ivanhoe – Winter Park, FL, USA – The government has issued laws regarding an adequate representation of women in clinical trials. However, these laws are only effective for trials funded by … See all stories on this topic

Heading into the weekend the news about trials related to a potential cancer vaccine continues to be the focus of interest around the world. And justifiably so, but also take a look at the story below about a potential TB vaccine now in trials. Such a breakthrough could alleviate untold suffering in Africa and throughout the under developed world… Have a great Saturday and Sunday!

Cancer Center Leads Breakthrough Clinical Trial: Cancer Vaccine … Medical News Today (press release) – UK – A recent clinical trial – led by Goshen Center for Cancer Care – has yielded promising results for the future use of a cancer vaccine … See all stories on this topic

New TB Drug Shows Promise In Clinical Trials – InjuryBoard.com – Tampa, FL, USA -Johnson & Johnson tested TMC207 in a Phase 2 trial of 47 South African patients with newly diagnosed MDR-TB of the lungs. Half of them received the … See all stories on this topic