Alzheimer’s Clinical Trial Rules Are Loosened
4 CommentsBy Ed Silverman // July 12th, 2011 // 8:15 am
A group of academic and industry experts has convinced the FDA to ease safety restrictions on clinical trials for Alzheimer’s drugs, which were imposed after a 2008 study of a developing med found cases of a brain-swelling condition known as vasogenic edema. That undermined confidence in the safety of drugs focusing on reducing levels of a protein that accumulates in the brains of Alzheimer’s patients.
The new guidelines, which are being published online today in the Alzheimer’s & Dementia journal, will allow some patients who develop brain swelling to stay in clinical trials, a move that may improve the odds for a drug called bapineuzumab, which is being developed by Pfizer and Johnson & Johnson, but caused a dozen cases of brain swelling in a study of 240 people (read here).
“We don’t want to compromise safety, but we also want to make sure as many people as possible can participate in Alzheimer’s clinical trials,” Maria Carrillo, senior director of medical and scientific relations at the Alzheimer’s Assocation tells Reuters. The organization sponsors a Research Roundtable that includes academics as well as various drugmakers, including Pfizer and J&J (see this).
The old guidelines restricted clinical trial patients from having more than two incidents of cerebral microhemmorhages, or tiny leaks of blood in the brain, before they enter a study. And frequent MRI scans were required to check for brain swelling or other problems that might be caused by experimental meds, she explains.
However, Carrillo says the new guidelines acknowledge many patients have had these types of brain events, and excluding those people from trials would make it more difficult to find effective drugs. “We were able to bring together all of the literature involved in the discussion of MRI abnormalities that could occur when you are aging with Alzheimer’s disease and when you are participating in clinical trials with an amyloid-modifying agent,” she says, referring to the beta amyloid protein (you can read the recommendations here).
An accompanying editorial, which was written by Carrillo; Rachel Schindler, a clinical disease expert in Alzheimer’s at Pfizer, and Howard Solomon, a Bristol-Myers Squibb vp and therapeutic area head in global clinical research in neuroscience, maintained that the “process that produced the recommendations and the report is an exemplary case of a recent movement in the fieldof AD toward collaboration and openness of all stakeholders, regardless of affiliation - academic, industry, advocacy,
or government - to advance the process of drug development” in Alzheimer’s.
“Broadening the restrictions would allow a better understanding of the potential risks and benefits of amyloid-lowering treatment,” Schindler tells Reuters. In May, J&J disclosed plans to seek FDA regulatory approval for bapineuzumab in 2012 or 2013, but analysts have said more studies may be needed because of issues with brain swelling.
pic thx to tocaboca on flickr
Mike Wokasch
Great news for patients and drug developers. This is certain to increase the number of Alzheimer\’s drugs to be studied and potentially approved for use. But, this is even better news for the product liability lawyers.
Alzheimer\’s patients who experience adverse effects, especially any sort of hemorrhage or brain swelling, will have plenty of legal help filing their law suits against pharma companies. Regardless of the prescribing information approved by the FDA, they will claim on behalf of their patient clients that the pharma company knew about these adverse effects and failed to adequately inform physicians and patients.
We need to get to a point where pharma companies are open, honest, and forthcoming about the potential for side effects and adverse effects but also where physicians take responsibility for the drugs they prescribe and patients take responsibility for agreeing to take the drugs. Nobody is forcing patients to take drugs and everybody knows, any drug can have the potential for adverse effects. http://www.PharmaReform.com
original industry insider
Here’s the rub. The apoE4 genotype is present in up to 64% of Alzheimer’s patients, but there is no way to know prospectively which fraction of the E4 patients will develop vasogenic edema. Thus you can’t screen out such patients before a trial. Although expensive, serial on-treatment MRI’s would seem to be the only way to pick this prtoblem up.
JaT
Hi Mike,
“Nobody is forcing patients to take drugs and everybody knows, any drug can have the potential for adverse effects.”
To refuse a doctors advice, depending on the doctor, can become a real problem. As does pharmas constant use of the word non-compliant. I will skip the many examples.
People see doctors as gods, pay them for their expertise, and really depend on their educations - lacking a similar education of their own. They are not well and are seeking help.
I see my doc as an advisor and question everything (why he puts up with me I do not know - many doctors would not and have not). It is a huge problem where people feel they must do precisely what a doctor suggests. Doctors are an authority of sorts and many people are not going to question them. This is why industry influence on doctors is such a big problem, imo, as they have a financial motivation.
Further, I believe most people think if it is FDA approved it is safe. That was once my own thinking. Between FDA and a doctor - a patient’s choice is not so obviously cut and dried. You see DTCAs for one side of the story. The only way some people see the other side is through attorney commercials - after the fact. So while I agree with you (my body - my choice - and I do not need attitude about it), I disagree with that part of your statement too.
To use the old car analogy. If you get new tires and a wheel falls off on the way home, harming or killing your family, you would not blame the car owner for not checking the lug nuts before driving off.
Mike Wokasch
JaT,
Completely agree but my point is that rather than lining up to sue the pharmaceutical company because you suffered an adverse effect, patients should take it up with their doctor (sue them if you like) for not warning you or for prescribing something that gave you the adverse effect. If he/she did warn you about the possible adverse effects, then you knew the risk. Patients do have a choice. If they decide to take prescription drugs, they should be expected to assume the risks. http://www.PharmaReform.com