What uses won’t the FDA allow when highly risky drugs are involved?
That seems like a fair question to ask after the agency said it had no objection to the psoriasis med Stelara being given to kids as young as 12 years old.
We’re talking about a drug that has been found to send the risk of cancer soaring and trigger Crohn’s Disease, bronchitis, “serious infections,” and a host of other terrible side effects.
All that, you might think, would be enough to get it restricted.
Instead, in possibly one of the most negligent decisions in the FDA’s checkered history, the agency has now allowed doctors to tell parents that this incredibly dangerous med is “FDA approved” for their children.
And when this big approval was announced, a spokesman for the National Psoriasis Foundation made sure to jump in and say how “essential” it is that these “younger patients and their caregivers have options.”
And guess what — the NPF lists Janssen, the company that makes Stelara, as one of its “gold” corporate members.
This is just one more reason why parents and grandparents have to be diligent in not simply taking a doctor’s — or the FDA’s — assurances, but carefully vetting any drug before permitting a child in their care to start up on it.
When the ‘theoretical risk’ proves true
Of all the meds put on pharmacy shelves by the FDA, the ones for psoriasis look to be the most treacherous.
Most of these drugs can knock your immune system for a loop. And when you disable that all-important defender of your health, anything can happen — including deadly infections, TB, and cancer.
But where Stelara is concerned, that cancer risk is off the charts.
Well over a year ago, the non-profit Institute for Safe Medication Practices (ISMP) warned about that risk in its quarterly report.
The ISMP found that Stelara can make your chance of developing cancer a whopping 15 times higher than another psoriasis med! And remember: It wasn’t being compared to aspirin or antacids, but to one of these similar types of drugs!
The group reached that conclusion by analyzing a very large number of people — over 38,000 — who were taking several brands of psoriasis meds.
The ISMP reported that ustekinumab (the generic name for Stelara), blocks not one, but two “elements of the immune system.” And despite the fact it was the first FDA-approved med to do that, the agency didn’t even require the drugmaker to produce what it called a “standard” analysis, where a drug is tested on animals to see if it causes cancer.
But that’s not all.
The longest running clinical trial for the drug (it was originally approved way back in 2009), excluded anyone who had any history of cancer. Despite that, in under two years of follow-up, cancers of the breast, colon, and pancreas were reported in those trial participants.
Janssen (which is owned by Johnson & Johnson) was hopping mad when the ISMP came out with its report, claiming that any warnings on the drug’s packaging were only about a “theoretical risk” of cancer. Simply unbelievable!
Which brings me back to the FDA’s new approval, one that will open the floodgates and allow Stelara to be advertised and administered to kids as young as 12. Why, this drug shouldn’t be taken by anyone, let alone children whose futures could be put in jeopardy.
And get this! The “largest single complaint” from “non-serious” reports sent into the FDA was that these drugs just don’t work!
Can you imagine risking your life — or your child’s life — for something that’s not even effective?
So, if you’re the parent or grandparent of a child suffering with psoriasis, what can you do to help?
Well, because psoriasis is an autoimmune disease, it responds very well to an anti-inflammatory diet. Exposing the affected skin areas to sunlight or light therapy is also frequently used with great success, as is keeping the areas moisturized.
You should also schedule a consultation with an integrative physician. And if you’re not sure where to find one, you can search the HSI database at this link: hsionline.com/findadoc.
“J&J psoriasis drug gets expanded U.S. approval for teens” Reuters, October 13, 2017, reuters.com