Healthcare going forward

[KaraBulut]

I understand the reasoning but that reasoning doesn't explain drug companies getting away with making similar unsubstantiated claims without any studies to back them up.

It's obvious who owns the FDA.

The "F" in FDA is for food. There's some regulatory functions in other agencies like the Ag Dept and USDA (which focuses more on meat and dairy production) but ultimately processed food regulation is a joint responsibility of the FDA and state inspectors.

In general, these companies know that the FDA is woefully underfunded. And in an Administration like the current administration that has used underfunding and understaffing government as a strategy, you can expect that corporations will figure it's better to ask for forgiveness instead of asking for permission.

When you look at how much much corporations make off exaggerated or fictitious product claims, it makes sense to take their chances that no one will call them with a "food labeling" lawsuit. Smaller companies can just hide behind bankruptcy to avoid paying fines and legal costs. Larger corporations can just settle for reduced profit margins.

The same is true for drugs. In the case of herbal and homeopathic remedies, Congress gave them statutory exemption from the normal FDA processes. In the case of traditional medications, it's seldom that the lawsuits are significant to lower profits and the public associates the drug with the brand name, not the corporation that markets it.

 

[gsdx]

The "F" in FDA is for food.

I know that, but I also know that the 'D' is for drugs, but that doesn't explain why drug companies get a free ride making claims that haven't been approved by the FDA. There isn't even a mention in the commercials that the claims are under investigation.

It just doesn't make sense to me. We just have to take their word for it that their drugs do what they tell us they do.

 

[frankfrank]

^ In a Trumpian world, after its full implementation, it will be entirely fine for Big Pharma to put nothing but corn starch into pills, and claim that it's a cutting-edge chemotherapy drug.

 

[Stardreamer]

Look what is going on with the FDA is their mandate covers inspecting food for general safety like making sure it's not spoiled or contains disease. They are charged with regulating drugs and that mandate is much tighter. BUT the charter of the FDA has what was thought to be a minor loophole that turned out to be massive. Because us crazy Humans eat and like a lot of crazy things in our food, they don't regulate food additives and vitamins like salt, pepper, etc. beyond basic toxicity. If it isn't poison they aren't going to ban it. Now you have a whole cottage industry out there that promotes food additives and vitamin-like products as having a health benefit and as long as they carefully skirt that line of not coming straight out and calling it a drug, they can get away with it.

Congress has tried to close this loophole before but generally, Republicans claiming an anti-regulation/ small government basis resist it. Though I'm sure the businesses who make a lot of money off these products to fund lobbyists are a major factor as well.

 

[cityboy-stl]

I know that, but I also know that the 'D' is for drugs, but that doesn't explain why drug companies get a free ride making claims that haven't been approved by the FDA. There isn't even a mention in the commercials that the claims are under investigation.

It just doesn't make sense to me. We just have to take their word for it that their drugs do what they tell us they do.

Do you have a specific example of a drug company making a non-approved claim that you are asking about? Are you talking about prescription drugs? Drug makers cannot, or are not supposed to, advertise that a prescription drug does something other than for what it is FDA approved. And to be approved there must be studies showing safety and efficacy.

 

[gsdx]

^ Not off the top of my head. There are so many drug commercials on television covering everything from heartburn to osteoporosis to diabetes to weight loss and the list goes on forever. There are as many drug commercials as there are personal injury lawyers.

Most times it's not easy to see and usually hidden in the fine print. I can't even remember the one I noticed which prompted me to post this question. I just saw the line in the fine print and it reminded me of the Cheerios fiasco from a few years ago and it struck me as utterly ridiculous.

 

[KaraBulut]

I know that, but I also know that the 'D' is for drugs, but that doesn't explain why drug companies get a free ride making claims that haven't been approved by the FDA. There isn't even a mention in the commercials that the claims are under investigation.

It just doesn't make sense to me. We just have to take their word for it that their drugs do what they tell us they do.

Backing up a bit...

There's a big ideological battle between liberals and conservatives when it comes to the role of the federal government in the US. As such, these federal agencies- particularly those agencies that came about during the New Deal- are given very controversial oversight powers that many Americans believe are not the purview of the federal government.

The FDA is chartered specifically for safety by a 1938 Congressional Act - the Federal Food, Drug, and Cosmetic Act. Their approval doesn't deliver any assurances that a particular drug does what it is advertised to do. Their approval only says that the studies done by the pharmaceutical company show that the drug is safe when administered for a particular condition. Once the drug is approved, the question of whether a product does what is claims to do is actually regulated by a different agency- the Federal Trade Commission which has the charter for consumer protection.

Does all of this sound illogical? It's intended to be. These agencies are understaffed and are constrained by the current political climate that is focused upon neutering the federal regulatory environment and weakening consumer protections.

Add to this another interesting aspect of the American system: there's no requirement that a prescribing physician prescribe a drug that is indicated only for a particular condition. It's this loophole that allows doctors to prescribe "off label" which is how anti-depressants get prescribed for Crohn's disease, pain control and migraines, for example. So, while pharmaceutical advertising is supposed to be consistent with the research that led to the drug's approval, there's no such requirement when the drug is prescribed.

 

[gsdx]

^ That all sounds like one giant loophole to me with the soul intent of confusing consumers. So, even that claim that the 'claims' on the product is not approved by the FDA really means nothing since the FTC does the approving?

Wow. Who knew that a box of Cheerios would be so educational?

 

[KaraBulut]

^ That all sounds like one giant loophole to me with the soul intent of confusing consumers. So, even that claim that the 'claims' on the product is not approved by the FDA really means nothing since the FTC does the approving?

Think of it this way- just like the legislative branch makes laws but the judicial branch enforces the laws that are broken, the FDA screens foods, drugs and cosmetics for safety but the FTC addresses after-the-fact false claims of efficacy.

If a drug is found to be unsafe, the FDA will pull it off the market (either via public complaints or legal action) but if the drug company makes fictitious or exaggerated claims about the drug after it was approved by the FDA, the FTC would intercede to fine the company for false marketing claims.

For example, if I were to develop a drug that contains radium, I would have to get FDA approval and in all likelihood, the FDA would not approve it based upon patient safety concerns. On the other hand, if I had a drug containing radium on the market and I claimed that the drug would cure impotency, chances are that the FTC would fine me for the false claims since there's no evidence that radium cures impotency. If hundreds of people died and thousands of people developed cancer, then the FDA would intercede (along with the judicial system via tort claims) to have the drug removed from the market (or if the FDA made a weak action, they would have a "black box warning" added to the drug's information that says that the drug can possibly cause cancer).

Sometimes the two agencies have to work together in regulatory actions- the FDA deals with the safety and pre-approval actions and the FTC deals with the consumer protection actions. Here's a cached example* of the two agencies working together:
https://webcache.googleusercontent....casts/ucm282161.htm+&cd=1&hl=en&ct=clnk&gl=us

*Worth noting: there's a lot of stuff on US government websites that has been disappearing over the past year. We knew that information about climate change and LGBT issues was being scrubbed from the federal agency websites. It appears that a lot of other stuff is also being removed so that there's no traces of rule-making and evidence gathering from "previous adminstrations".

 

[gsdx]

For example, if I were to develop a drug that contains radium, I would have to get FDA approval and in all likelihood, the FDA would not approve it based upon patient safety concerns. On the other hand, if I had a drug containing radium on the market and I claimed that the drug would cure impotency, chances are that the FTC would fine me for the false claims since there's no evidence that radium cures impotency. If hundreds of people died and thousands of people developed cancer, then the FDA would intercede (along with the judicial system via tort claims) to have the drug removed from the market (or if the FDA made a weak action, they would have a "black box warning" added to the drug's information that says that the drug can possibly cause cancer).

That's probably why we don't see products like these on the store shelves anymore.

Anyone for a little radium in their toothpaste?

https://io9.gizmodo.com/seriously-scary-radioactive-consumer-products-from-the-498044380

 

[Stardreamer]

So back to the original subject:
The Hill: GOP set to shift tactics on ObamaCare in 2018

With the GOP push to repeal ObamaCare possibly dead on arrival next year, conservative health care experts say the White House and Republican Congress should focus instead on containing what they see as the law's damage.

“It might be time for Republicans to recalibrate to think more in terms of containment, which is containing itself in terms of its future growth and spread, rather than some type of radical rollback,” said Tom Miller, a resident fellow at the conservative American Enterprise Institute think tank.

From all, I am reading the markets have reached a level of equilibrium and are showing no sign of imminent collapse even with the repeal of the mandate. With the loss of a Senate seat and little sign of gaining significantly more in 2018, the chances of a renewed Republican effort to repeal Obamacare is slim and none. Some insurance companies are figuring out not only how to work in the markets but thrive there. With the repeal of the individual mandate, it becomes very easy to now lay increasing costs at the feet of the Republicans as well as the Democrats.

So if repeal is done, we are more likely to see a real effort to finally try and fix things finally? What is the Republicans best approach for 2018 assuming that they realize that repeal is not a winning strategy going into the mid-terms?

 

[gsdx]

^ What did Trump's tweets mean after the Tax Reform vote that Obamacare was all but dead? I read that it had been sneaked into the bill. Or am I missing something?

 

[Stardreamer]

^ What did Trump's tweets mean after the Tax Reform vote that Obamacare was all but dead? I read that it had been sneaked into the bill. Or am I missing something?

The tax reform bill repealed the individual mandate. You are no longer required to have health insurance or pay a tax penalty after next year. That is going to cause an increase in premiums in the individual market but those qualifying for subsidies in the marketplace will not notice that as much. Conservatives are hoping that by killing the mandate, it would cause the system to collapse under its own weight but it looks like it is too late for that as the markets look like they are going to survive anyway.

 

[gsdx]

^ Boggled my mind is. Yes.

So, even when Trump wins, he loses. Maybe one day he'll realise he can't always have it his way when it comes to politics.

 

[ballcaphair]

^ Boggled my mind is. Yes.

So, even when Trump wins, he loses. Maybe one day he'll realise he can't always have it his way when it comes to politics.

We also lose. Whatever is not covered by insurance is covered by we taxpayers. (And Stardreamer, Real Conservatives do not let the state pick up the bill.)

 

[Stardreamer]

We also lose. Whatever is not covered by insurance is covered by we taxpayers. (And Stardreamer, Real Conservatives do not let the state pick up the bill.)

Hehe, my number one complaint about the tax bill. I don't have a real problem with lowering the corporate tax rate to make us more competitive, its when you have to put have to put $1.5 trillion-plus on our children's credit card bill to pay for it that is my biggest complaint.

 

[KaraBulut]

...So if repeal is done, we are more likely to see a real effort to finally try and fix things finally? What is the Republicans best approach for 2018 assuming that they realize that repeal is not a winning strategy going into the mid-terms?

The public makes a big mistake in believing that ACA=Individual Market.

This is about Medicaid and Medicaid expansion. There's only about 8 million people in the Individual Market. There's 15 million in the Medicaid expansion (and that's with only about 33 of 51 states plus DC participating in the expanded Medicaid!).

The House will focus on unraveling Medicaid. The Senate will drag its feet and avoid the subject. The White House will continue its cluelessness and continue focusing on undoing anything related to Obama.

 

[gsdx]

The House will focus on unraveling Medicaid. The Senate will drag its feet and avoid the subject. The White House will continue its cluelessness and continue focusing on undoing anything related to Obama.

It's interesting that your system is being unravelled while our system in Ontario is expanding. Beginning next year, Ontario will be offering over 400 free prescriptions to younger people 25 years old and younger as long as they have an OHIP card (Ontario Health Insurance Plan). Many of the prescriptions are for mental conditions and chronic health conditions such as diabetes, asthma, etc.

 

[ballcaphair]

Hehe, my number one complaint about the tax bill. I don't have a real problem with lowering the corporate tax rate to make us more competitive, its when you have to put have to put $1.5 trillion-plus on our children's credit card bill to pay for it that is my biggest complaint.

True and heartbreaking. We have sucker punched at least one generation.

 

[Kulindahr]

Hehe, my number one complaint about the tax bill. I don't have a real problem with lowering the corporate tax rate to make us more competitive, its when you have to put have to put $1.5 trillion-plus on our children's credit card bill to pay for it that is my biggest complaint.

It's not lowering the corporate rate that resulted in the $1.5tn additional debt, it's the breaks for the super-wealthy. It's typical GOP strategy: make things worse for the poor so they don't have the time or energy to be