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]
We should not have to dig so hard for the correct information and bless you for doing the job so well. The outrage is appropriate. Sign me up for the outrage club.
Good job Margaret …well spoken …keep it up.
Yes, well spoken: “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.”
Good study, Margaret
(Now I am looking for an oncologist who wants to talk about it…. )
It’s great that you’re digging deeper into these things, Margaret. And, in retrospect, we probably should have been a bit more detailed in our own coverage of the denosumab news back in The Myeloma Beacon’s article about it on Sep. 22.
All that having been said, the safety data published in the abstract that’s behind the Amgen press release does not indicate that denosumab is any less safe than the drug it was compared to (Zometa). The two drugs had the same rate (96%!) of adverse events, and the rate of “serious adverse events” was actually a bit lower in the denosumab group compared to the Zometa group (63% vs. 66%).
Now, the abstract doesn’t go into detail into what exactly were the “serious” adverse events in the two groups. Perhaps they were more serious in the denosumab group. Let’s hope the researchers make some more detailed data available soon.
The abstract is available online here: http://bit.ly/4wDAXC .
Again, thanks for keeping everyone honest!
Great stuff Margaret – rant away.
Great job Margaret at exposing more of the increasingly frequent conflicts of interest involved in the new drug approval process. Medical research results are far too frequently tainted and skewed according to the interests of the drug companies without regard to the patients who will be the recipients of these medications. The infiltration into agencies and scientific journals we once considered to be trustworthy and unbiased is an outrage.
Hear! Hear! Go get’em, Margaret!
Arrgghh! Drug companies are writing legislation to protect themselves and their profits; we shouldn’t be surprised that they are trying to pass off their drug trials as unbiased research. We SHOULD be surprised when a seemingly reputable organization falls for it hook, line & sinker.
Is there some reason you didn’t name the “main myeloma organization?” I’d be happy to participate in an “shame on you” email campaign.
Good rant! I’m a PhD in molecular cell biology and I will never trust a “result” that comes from a pharmaceutical company, without thorough testing by an outside source. Basic research in journals found on Pubmed, corroborated by at least one separate study, is the only way to go for facts.
If you ever have a problem accessing a journal article, please let me know and I might be able to get it for you. I’m starting to dig deeper into MM research because my sister was recently diagnosed, so if I come up with any new connections I’ll be sure to pass them along.
Thanks for your sharing all this information. You do a tremendous service to the field and the patients. Please keep it up!
Thanks, Margaret. You are a blessing and a treasure to the MM community. Fantastic work! Kudos.