Wednesday, August 02, 2017

PRECISION Trials

There was a release late last year of the PRECISION trials. These trials were part of a massive study on the danger of the good ol' household favorite ibuprofen. They were just evaluating the safety of NSAIDS. Those are drugs all Americans take over the counter for a myriad of aches and pains. Some, like Advil, are even candy coated.

Unfortunately, looks like they do cause problems and that an aggressive handling of them would take them off the market. Slight little elevated risks for a variety of things like heart attack, kidney problems, etc, but for the elderly the heart attack risk jumped by 40% in the short term. Drudge linked to this months ago due to some of the in the weeds bits in the study.

This works to Big Pharma's advantage. Do not think this would hurt them. This actually creates a new market for a new product for them. This is a generic over the counter so no monopoly protection. This is a cheap medication that only allows for product differentiation if it is candy coated (Advil). There is no loss for the Big Pharma firms if this is taken off the market or made prescription for patients over age 50.

There is a huge potential payout for Big Pharma. The grand opportunity that is dangling out there now for Big Pharma is tweaking the formula and releasing a new form with a *patent* that will be safe for the elderly who are covered under Medicare. Demand for anti-inflammatory meds is going to be there whether NSAIDS are available or not.

Say they tweak the formula to be a milder dose or a more targeted. Higher dose for a more limited time for sharp pains. This would require a scrip for older patients, but how many old people have aches, pains and arthritis? They just had their old ibuprofen taken away. How much will they clamor for a new drug? One that is approved by the FDA and covered under Medicare's prescription drug program.

Big Pharma then builds a new economic moat with government money paying for a drug that used to be generic and bought without a scrip at a low low price. This is rent seeking. The companies have cover for a government and research approved means of safely healing the elderly while also charging them significantly more for the good ol' NSAIDS they were used to in slightly different delivery.

The Left loves Big Pharma not just because they can use medical justification for their politics. Big Pharma acts as a fantastic disruptor for the intergenerational wealth transfer of those that do manage to save any money into old age. There is no limit on the extra, painful days the people that will receive your wealth will promise to you.

7 comments:

JB said...

Excellent post. I will have to look into this further as I take ibuprofen occasionally. Acetaminophen doesn't work as well for me. The Advil pills are coated with something, it didn't occur to me until now to investigate.

My long term goal is to never take prescription drugs and visit doctors only when absolutely necessary. See also Nancy Turner Banks' work,

peterike said...

"Acetaminophen doesn't work as well for me."

Acetaminophen is very bad for you, esp your liver. Never take it for a hangover or when a lot of alcohol is in your system.

Angry Midwesterner said...

Lesson of medicine: we can keep anyone alive indefinitely...and miserably

Sid said...

This is pathetic. Ibuprofen taken off shelves now ? Wow. I remember when I had to pay a doctor to prescribe asthma inhalers for me. Only in America.

grey enlightenment said...

Lesson of medicine: we can keep anyone alive indefinitely...and miserably

Not individuals with advanced cancer...most are dead within 2 years

DdR said...

The primary endpoint of the trial was to ascertain if Celebrex was more dangerous to use long-term versus NSAIDs. It turns out that they carry about the same risk.

The trial was not run to see how dangerous NSAIDs, although that was a secondary finding. However, the patients were taking NSAIDs for longer duration and at higher doses than recommended OTC.

There is no alternative to COX inhibitors to treat arthritis pain and inflammation simultaneously. It will take pharma a long time to develop an alternative and bring it to the market that carry reduced risks.

No way are they going to take Advil off the shelves of America now. Just like they won't ban alcohol, cigarettes, or aspirin, even those pose significant risks long-term. NSAIDs are cheap miracle drugs for short-term pain and inflammation and carry minimal risks. It's only long-term, when they can begin affecting the stomach lining and kidney function, that an alternative should be sought.

Frankly, I'm confused why Pfizer funded this trial when celecoxib has now gone generic.

Angry Midwesterner said...

Pfizer funded the trial because after vioxx was a disaster, the FDA coerced them to keep celebrex, another cox2, on market.
Cox 2 inhibitors are already definitively better than non-specifics (ibuprofen) with regards to stomach side effects. The study design wasn't perfect given that it was non-inferiority, and it was mainly done in NSAID dependent patients found
in rheumatology clinics.

Given the increase in heart attacks
and tha blood pressure all NSAIDs cause with chronic usage, the system WANTs you to go through a PCP.

Landry is right about the shit pharma pulls. What happens with the insulins is a great example: glargine/toujeo/Lantus/basaglar is all the same damn thing