Denosumab

October 3 2009 post, “Ranting and raving”: I am still astounded at what I read yesterday in the October 1 newsletter of one of the main myeloma organizations. At first glance, I thought that the news item about denosumab, a monoclonal antibody currently under study for the treatment of osteoporosis and some types of cancer, including multiple myeloma, sounded quite interesting.

The title: “Amgen has positive results from Phase III trial of denosumab.” And the item reads as follows: Amgen announced results from a Phase III trial of denosumab in advanced cancer patients with multiple myeloma or solid tumors that showed the drug delayed the median time to first on-study skeletal related event by 4.3 months.

I wanted more information, so I clicked on the “read more” link. To my surprise, I was led DIRECTLY to Amgen’s own press release about denosumab. Huh? Hello??? Is a drug company’s press release considered to be an unbiased, reliable source of information? I mean, what if I based my blog research entirely on press releases and/or information from Heather’s Healing Herbs & Potions (=an invented company name, btw)? I think you get my point. Ridikkulus!

Well, I decided dig deeper. Let me make it clear that I had no idea that I would uncover any problems. But I did. Yes indeed, there may be some very serious problems with denosumab. Now, I don’t usually rant and rave, nor do I even like to rant and rave, but I think this deserves a bit of a rant.

It didn’t take me long to find a number of unsettling details concerning denosumab. See, e.g., this MedPage Today article titled “FDA Questions Denosumab Safety in Advisory Meeting Documents,” based on evidence from a denosumab-osteoporosis trial: http://tinyurl.com/ya6h99s

From the FDA report (taken from the above link): “Overall, subjects in the denosumab group had a slightly increased incidence of serious infections,” according to the briefing document. “There were more serious infections of the skin, ear, abdominal system and urinary tract. Also, endocarditis, infected arthritis and skin ulcers occurred more commonly in denosumab subjects. There were three denosumab subjects in phase I studies who developed pneumonia requiring hospitalization following a single dose of denosumab.” The document also noted that while Amgen did not perform carcinogenicity studies in animals because denosumab is not active in normal mice or rats, the clinical data showed a modest increase in certain malignancies in the human subjects. “Three subjects receiving a high dose of denosumab in [a] dose-finding study died of a new malignancy,” the staff review found. Those individuals received 100-mg doses, whereas 60 mg was used in the phase III studies and would likely be the recommended dose upon approval.

(I cannot quote the entire thing, but to read more just click on the above tinyurl link. Make sure you read the part about the “unhealthy changes in bone structure.” Oh, btw, let us not forget that, apart from having osteoporosis!, the trial participants were otherwise healthy women…)

The question is obvious: shouldn’t immunocompromised patients be informed of any potential problems, particularly the possibility of developing “serious infections”? Bloody hell, indeed we should!!! Infections kill so many of us…

But in the myeloma organization’s newsletter, and of course (duuuh!) in the Amgen press release, you will find nothing about all these potentially very serious issues for myeloma patients. Not one word. Hmmm, I just discovered also that Amgen is one of the MM organization’s corporate sponsors…no comment necessary…

To say I am disappointed is to put things mildly. I am bloody outraged! When our own myeloma organizations start using drug company press releases to provide us with important medical information, it is our duty to speak out.

This is rubbish, absolute rubbish.

Things have got to change. We can no longer afford to ignore the heaps of scientific studies that demonstrate the anti-myeloma effects of non toxic plant extracts. These compounds have the potential to improve the quality of our lives without harming us in any way (I am a case in point)…furthermore, many of them have been used for thousands of years in Ayurvedic medicine, that is, they already have a good safety profile.

For those of us who are stable, these compounds may slow down, or perhaps even halt!, progression to active myeloma. And heck, there may even be a cure for myeloma in there somewhere. But we will never know for sure, unless these compounds get tested, alone and in combination, in a clinical trial setting.

It is time for us to demand that the promising, non toxic compounds, such as picropodophyllin, be tested in MM and MGUS and SMM clinical trials. Not some day in the bloody future, but RIGHT NOW!!! 

[More details: http://tinyurl.com/ycap484]

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