We Have a Horse in this Race

A single federal judge recently issued a ruling demanding removal of an abortion drug from the market. Part of the judge’s ruling was that the FDA had not taken sufficient account of the psychological effects of the medication. FDA approval was 23 years ago, and the drug has been widely prescribed for decades. If allowed to stand, this ruling will apply nation wide. Regardless of how each of us may feel about abortion, we should recognize the threat this decision poses. Many of us are alive only because of a variety of FDA approved ADT drugs used to suppress and interfere with our hormone levels. Some are new, but many have been around for years. It is a sure bet that most of us have experienced psychological SE, including, but not limited to feeling down, discouraged and perhaps depressed. If the federal judge’s decision stands, it will only require one disgruntled ADT user to go judge “shopping” to destroy access to these medications. We very much should be concerned… Bill

Setting aside the (very hot) issue of what type of medicine this particular drug is (if we can), there is the basic issue of a body other than the Congress (let alone a single person) invoking non-existing power over the FDA for drug approval. Very troubling indeed.

(On an aside, medical abortion is still possible with two doses of the 2nd medication medication, misoprostol, which is still legal throughout the U.S., at least for now. But I understand this regime is not as reliable, has more adverse effects, and has been much less commonly prescribed.)

To keep this thread unlocked, I suggested we limit the discussion to the drug-approval process in general.

Djin

FDA-approved cancer-fighting treatments and medications should always be available to all who are diagnosed ~ simply put.

I wish the price of cancer-fighting medications (and for other illnesses, as well) would always remain accessible and AFFORDABLE to all, in times of need.

I really wish there was more focus on these factors ~ accessibility and affordability.

We've also recently heard there are "supply chain" concerns with the availability of newly approved PLUVICTO (Lutetium-177), which several of our compadres here have now started.

I hope a light can be shone brightly upon these issues ...

Drums to beat ... thoughts to share ...

CYCLONE ~ # Iowa State University

Interesting post, MATTAM ...

Yes, I agree ... the price for XTANDI should be lowered!

Many of us here well remember when JOHNSON & JOHNSON lost its lucrative court battle to protect its patent on ZYTIGA.

A generic version (Abiraterone Acetate) emerged, and many of us got rolled over to the generic version by our insurance companies.

I remember being a little worried about the generic, but my doctor assured me that its efficacy was exactly that of brand-name ZYTIGA.

Those medication patents ARE lucrative, and at least generics are a small step forward in lowering medication prices.

CYCLONE ~ # Iowa State University

I see no valid role for a federal judge overturning any treatment that has been approved by the FDA based on valid medical studies.

As for cost I am one of presumably a small number of advanced PCa patients who is able to get my Abiraterone Acitate (Zytiga) at zero cost through the VA pharmacy - even though I get my cancer treatment through Dana-Farber under my Blue Cross Medicare Advantage plan. Under my Blue Cross plan my annual out-of-pocket co-pay would be $10,000 for the same drug. How is this sane or fair policy?

The scenario that Mumbo describes is not uncommon, unfortunately. I have seen it with one of the drugs that I am taking as well.

I was reading an article which stated the FDA issued a notice on March 7th that there will be a major & impactful shortage of PLUVICTO (Lutetium-177) for the next four months.

Several of our battle brothers here have pursued PLUVICTO treatments.

It's a worrisome and critical situation, to be sure!

CYCLONE ~ # Iowa State University

It’s bad enough when an insurance company can direct our healthcare but when politicians/judges get a say, we are headed down the wrong road.

Here in Montana, like in other places, the legislature is banning some types of healthcare for minors even when they have parental approval. This is coming under the banner of protecting “bodily autonomy.” If it goes through, which looks likely, I want to see piercings, tattoos, and male circumcision swept up in it as well just to prove that politics shouldn’t be involved in healthcare decisions.

Good job by everyone keeping it apolitical. Keep it up 😄

I’m with Todd on this. These legal disputes get worked out, often quickly, at the SCOTUS level, as we see with this one. I remember the PCa expert members of the FDA review board that delayed Provenge because they had interest in a competing drug (which was a bust). Thankfully for many, especially brother Todd, this was overcome and Provenge was approved. And as for bodily autonomy, as long as we have people and interest groups with diverse ideology, political narative, financial interests, etc.; we will have these disputes be it abortion, gender, vaccine, lockdowns, masks, supplements, medical assisted suicide…….you name it. And this ranges from individuals exercising their narrow domain to the commercial companies, political parties, NGOs and the governments.

Best thing that keeps me sane is to not take the initial news very seriously and allow our processes to work. More often than not they do, thankfully. Don’t worry….be happy.

JNF said...
….Best thing that keeps me sane is to not take the initial news very seriously and allow our processes to work….

Yes, the reporting of history is a better arbiter of truth than current events.