AlexO'Meara.com » globalization

In the U.S. do we only know how to give money?

Alex — Tue, 11 May 2010 20:24:49 +0000

I traveled to Uganda as part of my research for Chasing Medical Miracles. I had no idea what to expect when I got there. What I found was people who were kind, patient, strong, capable, intelligent and, more than anything else – and at the risk of sounding sing-songy – beautiful. They are also increasingly dying. That AIDS is devastating the country and all of Africa is not news. That U.S. funding for treatment and drug cocktails to extend life is slipping because of the economic crisis is news and, as this article in the today’s New York Times makes painfully clear, it is disturbing. It signals that in the United States our involvement in many causes is only financial, that it goes only so far as our check books. Is there more that we can donate than cash? Our expertise? Our presence to help those dying to help their families continue, to help prevent increased outbreaks? Are we only a nation of money givers or are we a nation of people who care so much that we will extend ourselves to the point of inconvenience to help others? The answer to that troubles me.

Dinavance Kamukama, 28, front right, with her cousins in Kampala, Uganda. She is on a waiting list for AIDS medication.

Pfizer’s Reputation

Alex — Tue, 27 Apr 2010 17:39:57 +0000

When I travelled to Uganda as part of my research into my book I wanted to stop into a clinic in Kampala that was run by Pfizer. I contacted their media office and we went around and around and was told I couldn’t visit the Infectious Disease Institute (IDI), which is on the grounds of Mulago Hospital. The reason was that only a limited number of trials were conducted there. Once in Kampala and interviewing officials I asked about the Pfizer clinic. One prominent doctor at Nsambya Hospital said IDI conducted a significant number of trials. A Ugandan health official said no trials were conducted at IDI. I was left wondering what was accurate: some trials, no trials, or lots of trials. What I was sure of was that Pfizer appeared to be a slippery operation when it came to trials . Recent articles have showed this to be true:

From the Wall Street Journal (subscription):

FDA Warns Pfizer On Clinical Study Of Antipsychotic Geodo

From Bloomberg/Business Week:

Pfizer’s Geodon Trial Had ‘Significant Violations’ (Update2)

The Courier Post:

Pfizer not fixing test problems, FDA says

AIDS/HIV Vaccine Breakthrough Announced

Alex — Thu, 24 Sep 2009 17:16:53 +0000

Amazing. Truly amazing. The news today is that an AIDS vaccine has shown remarkable progress in clinical trials in Thailand. (Read AP story here.) There have been more than 100 AIDS vaccine trials in the last 20 years and none of them have gotten close to showing the kind of promise this one is showing. However, as we all know, it is only promise – not a cure or preventative. Much can go wrong. As one scientist soberly said about the findings of the trial: Now the work begins.

Having travelled to and spent time in eastern Africa to research Chasing Medical Miracles, I cannon overstate the thorough and heart-wrenching devastation left by AIDS/HIV in poorer countries. There is also a measure of shame to be shared by developed countries in the way we have relentlessly pursued cures and vaccine trials in Africa and other underdeveloped nations. While TB and malaria have throughout history and today killed and harmed more people Africa than has AIDS/HIV, trials to treat and cure those conditions are much more rare than for AIDS/HIV. The reason? TB and malaria and rare in western countries so there is no motivation to conduct trials for drugs for which there is no market. If AIDS/HIV were not prevalent in the western, developed world, you can bet few trials to seek a vaccine or cure would be taking place in the under developed world.

In other recent news… one reports says there have been no serious side effects in trials on an H1H1 vaccine while a German man (in a story on a site that is not as reputable as say, the New York Times but is worthwhile to have a quick look at) claims the experimental H1N1 vaccine dose made him seriously sick. Hmmm … clinical trials registries, which are now mandatory, rarely report results from trials, which kind of misses the point of the entire idea, huh? … and the FDA gives the go ahead to stem cell trial to treat Lou Gehrig’s disease, a positive and potentially groundbreaking decision on moving ahead with an entirely new category of treatments and cures for hundreds of debilitating conditions.

H1N1 Vaccine Clinical Trials in Adults Free of Serious Adverse Events – Zikkir World (blog) – No serious adverse events have been reported during the first two weeks of clinical trials involving vaccine against the novel influenza A (H1N1) virus … See all stories on this topic

H1N1 Swine Flu Vaccine Makes German Man Extremely Sick During … Prison Planet.com – And now a German man who participated in H1N1 Swine Flu Vaccine clinical trials has said that he became seriously ill as a consequence of theH1N1 Swine Flu … See all stories on this topic

Clinical Trial Registry Includes Few Results – FDA news (subscription) – Nearly 80000 clinical trials have been registered with the NIH website ClinicalTrials.gov in the two years since the FDA Amendments Act made registration … See all stories on this topic

FDA green lights stem-cell clinical trial for Lou Gehrig’s disease – Nature.com (subscription) – Other companies using neural cells include ReNeuron, which received permission from UK authorities this January to start clinical trials for stroke … See all stories on this topic

Little kids to need 2 shots for swine flu – Baltimore Sun – In the clinical trials, the swine flu vaccine produced a strong immune response in children 10 to 17 years old in just 10 days; younger children generally … See all stories on this topic

Turning down trials, cool apps, and swine flu

Alex — Fri, 07 Aug 2009 15:24:50 +0000

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, there’s a 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 … See all stories on this topic

Clinical trial app choices: Expensive, for charity or in-the-making – mobihealthnews – The market for clinical trials-focused mobile applications just got competitive and complicated. During the past week two new contenders announced … See all stories on this topic

Big drugmakers start trials of swine flu vaccines – Reuters – The launch of clinical trials is a key part of a widening program of work being undertaken by big pharmaceutical companies as they prepare for mass … See all stories on this topic

Swine Flu Spreading; Drug Makers Begin Clinical Trials – DOTmed.com (press release) – Approximately 6000 people of all ages in the US, UK and Germany are being tested and the trial is expected to last for one year. Novartis said the vaccine … See all stories on this topic

Diane Rehm Show about Chasing Medical Miracles

Alex — Thu, 30 Jul 2009 15:37:45 +0000

I was on the Diane Rehm Show, out of WAMU in Washington DC, yesterday, July 29 to discuss Chasing Medical Miracles and clinical trials in general. Susan Page, the Washington bureau chief for USA Today was the guest host for Diane. I thought the hour was interesting and wide-ranging but you can listen and decide for yourself by clicking here, http://wamu.org/programs/dr/09/07/29.php#27148 for either a Real Player or Windows Media version of the interview.

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

Alex — Fri, 03 Jul 2009 16:42:47 +0000

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 … See all stories on this topic

Some clinical trials found to be biased – Examiner.com - USA – Recently there have been numerous reports suggesting that in the rush to get these drugs to the public, clinical trials may not only be poorly executed … See all stories on this topic

First Clinical Trials Completed of Adult Cardiac Stem Cell Repair – Lifesite – Pittsburgh, PA, USA – Milles is part of a 24-patient clinical trial that is the first test in using adult stem cells from a patient’s own heart to attempt to heal injured heart … See all stories on this topic

Clinical Trials Update – U.S. News & World Report – Washington, DC, USA – If your child (boys aged five to eight and girls aged five to seven) has had allergy symptoms for at least one year, he or she may qualify for this study … See all stories on this topic

Study of Sepracor’s Depression Drug Has Investors Gloomy – Inside Futures – Chicago, IL, USA – As if that disappointment was not bad enough, Sepracor received additional news about clinical trials of the pediatric Lunesta. Lunesta is the company’s … See all stories on this topic

FDA Approves Sanofi Heart Treatment – New York Times – United States – He called for more clinical trials. Stock analysts expect slow adoption of the drug, because of the cautions about its use, but ultimately consider it a … See all stories on this topic

Life Science Leader Magazine – Trials Or Tribulations: Does Patient Recruitment Offer Acceptable ROI? – Life Science Leader Magazine – Erie, PA, USA – Delays in meeting enrollment objectives for clinical trials are clearly a challenge that clinical teams will continue to face in the future … 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

Life Science Leader Magazine – Bring Your Oncology Drug To Market Quicker: Think Patients First – Life Science Leader Magazine – Erie, PA, USA – Why is oncology clinical trial enrollment so difficult? The supply of adult cancer patients willing to participate in clinical trials remains stagnant at 3% … See all stories on this topic

Randomized trials published in some Chinese journals: how many are ... 7thSpace Interactive (press release) – New York, NY, USA – We investigated the adequacy of randomization of clinical trials published in recent years in China to determine how many of them met acceptable standards … See all stories on this topic

Pfizer’s Sutent fails in colon cancer, trial halted – Reuters – USA – Pfizer said it would continue to study Sutent in late-stage trials as a potential treatment for various other types of cancer and work to develop other … See all stories on this topic

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

Alex — Mon, 15 Jun 2009 16:03:58 +0000

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

Recent releases: HIV prevention; clinical trials debate … News-Medical.net -Sydney, Australia – This month’s PLoS Medicine Debate addresses global health research in light of three large vaginal microbicide clinical trials that have recently failed. … See all stories on this topic

Clinical Trials Update – June 11, 2009

Alex — Thu, 11 Jun 2009 16:42:06 +0000

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

Cancer treatment impaired by lack of female clinical trial … Private Healthcare UK – UK - Cancer treatment is being hampered by a deficiency in the number of women participating in cancer clinical trials. This is the finding of a recent study due … See all stories on this topic

Juvista European Phase 2 clinical trial – PharmaLive.com (press release) – Newtown, PA, USA – In this trial Juvista was given once at the time of surgery. Other clinical trials (particularly 0036 & 0050) have demonstrated that Juvista’s efficacy can … See all stories on this topic

New back pain treatment technology to get trials at Long Beach … Long Beach Press-Telegram – Long Beach, CA, USA – A new technology that hopes to streamline the treatment of neck and back pain will be tested in clinical trials at the hospital beginning in late July or … See all stories on this topic

New ‘BrainGate2′ trial recruiting volunteers – Boston Globe – United States - More information is available at the government’s web site where clinical trials are listed or from Mass. General at 617-726-4218 – See all stories on this topic

Clinical Trials Have a Role in Comparative Effectiveness Research – Thompson.com – Washington, DC, USA – Although traditional clinical trials will still be important, Tunis noted that “it will be necessary to go beyond the current approaches to conducting … See all stories on this topic

Examiner.com – Initial results from clinical trials of a DNA vaccine for type I … He recently presented interim clinical trial data at the American Diabetes Association 69th Scientific Session in New Orleans. Type I diabetes patients who … See all stories on this topic

Clinipace Turns to Crossroads Public Relations to Promote … dBusinessNews Triangle (press release) – Raleigh, NC, USA – Clinipace, an experienced digital clinical research organization (dCRO), provides on-demand software and clinical services for phase I-IV clinical trials … See all stories on this topic

Impact Medical Solutions, Inc. (dba iTech Medical) Expands … Business Wire (press release) – San Francisco, CA, USA – Impact Medical Solutions, Inc. (dba iTech Medical) (OTCBB: IMSU) announces MPR clinical trials at the Long Beach Memorial Hospital campus with the … See all stories on this topic

Biotech Calendar: Key Clinical Trial Dates – TheStreet.com – USA – On the heels of the drug approval decision calendar, I’ve compiled a new list of clinical trial results expected before the end of the year. … See all stories on this topic

Clinical Trials News Update – May 29, 2009

Alex — Fri, 29 May 2009 15:56:09 +0000

Money money money! There’s lots and lots of business news about clinical trials today. It’s a good reminder that this is a $24 billion-a-year industry that, from all indications, is weathering the recession well. Investments in trials for a flu vaccine in the United States, the development of trials and green technology (a new and potentially fascinating aspect of trials emerging now), even the impact of good ‘ol aspect are all being studied around the world and can be found in today’s update.

Australia CSL: gets $180 mln US flu vaccine order – Reuters – USA – CSL expects its H1N1 vaccine to be ready within a few months, with the company planning to start clinical trials to make sure the vaccine is safe and … See all stories on this topic

Game development, clinical trials and green technology among … KUSI – San Diego, CA, USA – The UC San Diego Extension report released yesterday also finds that jobs dealing with work in clinical trials and the development of green technology are … See all stories on this topic

Routine aspirin benefits queried – BBC News – UK – Analysis of date from over 100000 clinical trial participants found the risk of harm largely cancelled out the benefits of taking the drug … See all stories on this topic

BusinessWeek – USA – Bianco says positive data from ASCO will change all that, and already the stock has climbed to $1.24 since the clinical trial summary on Pixantrone was … See all stories on this topic

medicinova Announces Plan to Modify Its Phase II Placebo … GlobeNewsWire (press release) – Los Angeles, CA, USA – “These clinical results from our three completed Phase II clinical trials support the potential efficacy of lower doses of MN-221 plus standard treatment in … See all stories on this topic

Companies starting work on H1N1 vaccine- CDC – Reuters – USA – by Julie Steenhuysen CHICAGO, May 28 (Reuters) – Companies are starting preliminary work on a vaccine for the new H1N1 flu and should begin clinical trials … See all stories on this topic

Incyte Provides Update on Special Protocol Assessment for … WELT ONLINE – Berlin, Germany – Incyte’s pipeline includes multiple compounds in Phase II clinical trials for oncology, inflammation and diabetes. For additional information on Incyte … See all stories on this topic

Exelixis inks potential $1 billion deal Sanofi-Aventis – Bizjournals.com – Charlotte, NC, USA – Exelixis may be responsible for certain clinical trials, it said in a press release Thursday. The deal is Exelixis’ second this month … See all stories on this topic

Clinical Trials Update: May 28, 2009 U.S. News & World Report – Washington, DC, USA – If you have a history of ankle sprains, have weak ankles, and have not sprained your ankle in the previous six weeks, you may qualify for this study … See all stories on this topic

Valley cancer researchers hit the jackpot! – KPNX-12 – Phoenix, AZ, USA – This morning on 12 News Today Dr. Ramesh Ramanathan, Medical Director at the center said the money will do much for necessary clinical trials. … See all stories on this topic

Clinical Trials News – May 18, 2009

Alex — Mon, 18 May 2009 15:37:43 +0000

Controversy doesn’t derail stem cell progress – USA Today – USA – Unfortunately, he suggests that many of the things that drove gene therapy to try clinical trials before the biology behind the science was understood are … See all stories on this topic

Oncolytics Biotech Research Collaborators to Present Data on … Trading Markets (press release) – Los Angeles, CA, USA – … data from three clinical trials using Reolysin are scheduled to be presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting … See all stories on this topic

Plea to Brown for stem-cell research millions – Scotsman – United Kingdom – The MS society, which represents sufferers of the disease, said that without large-scale government support for clinical trials the new hope offered by … See all stories on this topic

Large clinical trial finds pirfenidone may help lung function in … EurekAlert (press release) – Washington, DC, USA – ATS 2009, SAN DIEGO—A large, well-controlled, multi-national clinical trial program has demonstrated the effectiveness and safety of what may become the … See all stories on this topic

Northfield Labs will close doors after FDA rejection – MarketWatch – USA – … Ill. “[Further] clinical development” of the product, “including additional clinical trials, would likely be required before [the company] could again … See all stories on this topic

medsource Awarded Services Contract for a Phase III Epilepsy … PR – USA.net (press release) – Varna, Bulgaria – medsource, a Contract Research Organization (CRO) providing Phase I-IV clinical trials support, announced it has been awarded a service contract to manage a … See all stories on this topic