Written by Alex on July 14, 2010 – 8:54 am
The NYT is live blogging the debate on whether to pull the diabetes drug Avandia from the shelves. A federal advisory panel is hearing testimoney about how safe it is, how safe it isn’t, what the problems may be… when did science becaome so much about opinion? When did clinical trials have so much wiggle room? Makes one wonder. But, enough, now to the blogging …
Written by Alex on February 23, 2010 – 11:55 am
The article will probably have hundreds if not thousands of cancer patients running to their computers and phones to try and get into a trial – any trial – because this article has led them to believe trials can provide a cure. Promoting that kind of false hope is not only bad journalism, it’s just plain mean to patients seeking a cure for cancer.
Written by Alex on January 20, 2010 – 10:05 am
The Clinical Journal of Oncology says in a new study that researchers with the greatest influence over cancer clinical trials also have the closest financial ties to the pharmaceutical and other industries that benefit from positive clinical trials’ results. This is a disturbing and alarming finding but, unfortunately, not surprising,
Written by Alex on October 23, 2009 – 2:51 pm
…On pages 49-51 of Chasing Medical Miracles I wrote, “Therapeutic misconception is also a significant issue and is thoroughly built in to how trials function today.” Things don’t get much clearer than that. I only hope that now, with this story about Dr. Stratton in the New York Times today, pehaps people with the power to change this deplorable practice in research will start to listen and change things…
Written by Alex on October 22, 2009 – 9:58 am
A story headlined “Cutting-edge therapy is one reason why many participate in clinical trials” in the Indianapolis Star by Barb Berggoetz about why people enroll in clinical trials is indicative of an overall bias on behalf of the media toward encouraging participation in trials. Most stories about trials stress the positive outcomes. Some are so blatant as to almost seem like a public service announcement for the institution or business conducting the trial. The articles, like the one below, always mention risks. But, like I wrote in Chasing Medical Miracles about my own experience becoming aware of the real risks of any trial: “The trial up until now had been like taking a trip to Disney World. Before your plane takes off they tell you in detail what to do if it becomes a fireball of screaming death and dives nose first into the ground. But you don’t hear that part. You’re too busy thinking about shaking hands with Goofy.”
Written by Alex on September 15, 2009 – 9:06 am
Published results of clinical trials so far indicate one dose of the vaccine being tested could be enough to inoculate the more than 159 million people in the U.S. who are expected to be at risk to contract the flu this season. That’s good news but – and this is big – these trials are being hurried along. The process as much as the vaccine is a test and the results could be surprising in unanticipated ways. I am loathe to be a downer about this (although I appear to one of the only ones who is not doing backflips over the apparent success so far of all efforts in HINI clinical trials) because the effort to test the vaccine is impressive, appropriate, and in the best interest of the public health. But, as always, stay tuned for all shoes to hit the ground.
In other news, the American Medical News examines the ethical considerations of outsourcing pharmaceutical clinical trials to developing countries, a topic close to my heart since my trip to Uganda to see the unfortunate exploitation of people there ..
Written by Alex on August 26, 2009 – 8:32 am
Swine flu – or the H1N1 influenza pandemic – is THE story in clinical trials and in medicine right now. It looks to continue to be the object of intense focus and fascination until at least the winter, when the flu is expected to either impact millions of people or be blunted by the distribution of a vaccine. It is the vaccine, of course, that is now under clinical trials testing. However, the trials are being conducted in an interesting way that involves first producing the vaccine and filling the vials for shipment before the trials are finished. This poses significant risks yet also carries the possibility for great success in stemming the spread of the flu, depending on how things go.
The story below is a good overview of things right now. I will keep updating events as they move forward. Let me know what you think.
Written by Alex on August 11, 2009 – 1:24 pm
In an article called Trial and Error, Washington Diplomat magazine talks about Chasing Medical Miracles (including a sidebar) in its August issue. The article by Gina Shaw is a nice look at the overall topic. Seeing how “the Washington Diplomat is an independent monthly newspaper with a readership of more than 100,000… distributed to all Washington-based foreign embassies, the United Nations in New York, the World Bank and IMF Group, the U.S. State Department, Capitol Hill, the White House and many other points of influence within the greater metropolitan area,” here’s hoping clinical trials will come to the close attention of those who can examine and maybe even improve how they function.
Written by Alex on August 9, 2009 – 9:20 am
Researchers involved in clinical trials are being so choked by bureaucratic red tape that their research is suffering, according to Sally Satel, a scholar at the American Enterprise Institute in an op-ed piece in Friday’s New York Times. Satel’s insights are valuable because they point out that thickets of regulations often don’t protect subjects. She however misses the larger point that the red tape and lack of subject protection in what she in the article refers to as the “dysfunctional system” of clinical trials is due mostly to their explosive growth and commodification in the last decade.
Written by Alex on August 7, 2009 – 8:24 am
Some really fascinating stories get us going into the weekend. Interesting and heartfelt responses to NYT article about cancer trials and why people don’t volunteer for trials… although I’m not convinced of their necessity at all, very cool story about iphone and Windows apps for clinical trials … and an update on efforts in the U.S. and abroad about progress on trials for a swine flu vaccine…
Why Patients Turn Down Clinical Trials – New York Times – I read with interest your article about the chilling effect that low recruitment for clinical trials has had on the search for meaningful treatments.