The FDA Systematically Covers Up Fraud & Misconduct In Drug Trials

[FarmerD]

Found this on Zero Hedge.  Yeah, Zero Hedge has a lot of conspiracy articles but I tend to believe this one.  Sadly, I fully admit to taking any advice my doctor gives with a grain of salt.  It's not I think my doctor is evil, greedy or stupid, I just think most medical advice is either not backed up by sound research or is based on biased recommendations by the AHA, ADA, etc.  In my opinion, the medical field is entering a state of crisis where people like me frequently ignore doctor's advice and self treat or seek alternative medicine treatment.   

From the article.
“Once the corruption reaches a certain level of societal saturation, you create a culture in which people simply stop trusting everyone and everything. For obvious reasons, this is a very dangerous development. There are people whom you need to trust for any civilization to function reasonably well. Police are one, but doctors are another. I can speak for myself when I say that I am not convinced that any medical professional I see has only my best interests at heart. I seriously wonder how he or she is balancing my health with the ability to earn more money. From conversations with friends and family, I have found that this is much more widespread than we would like to admit. This is incredibly bad and incredibly sad.”?


http://www.zerohedge.com/news/2015-02-1 ... rug-trials

[MachineGhost]

Very MachineGhosty!  Two thumbs up! 

[Benko]

In my opinion, the medical field is entering a state of crisis where people like me frequently ignore doctor's advice and self treat or seek alternative medicine treatment.

And this is a bad thing because?

Conventional western medicine is supurb at certain things and not so good at other things.  Why shouldn't you question everything, research things and decide what the best treatment is for you?

[Pointedstick]

In my opinion, the medical field is entering a state of crisis where people like me frequently ignore doctor's advice and self treat or seek alternative medicine treatment.

And this is a bad thing because?

Conventional western medicine is supurb at certain things and not so good at other things.  Why shouldn't you question everything, research things and decide what the best treatment is for you?

On a micro level, it's great. On a macro level, it's yet another institution that is (perhaps rightly) losing the public trust, which is saddening.

[FarmerD]

In my opinion, the medical field is entering a state of crisis where people like me frequently ignore doctor's advice and self treat or seek alternative medicine treatment.

And this is a bad thing because?

Because doctors should be a source of unbiased advice with the patient's best interests in mind.

[MachineGhost]

Here's the original article in case anyone thinks Zero Hedge has little to no credibility:

Are Your Medications Safe?
--- Charles Seife in Slate

Too bad its not in a paper of record.  I really don't know why Americans are not fed up and demand abolishment or reform.  How many more decades of Fraud and Death will it take?   The cynic in me says nothing will change but atomized technology will just simply circumvent and make the FDA obsolete.  Very hollow victory.

[Benko]

In a different world, one would expect to see medical professionals themselves speaking out against the FDA for keeping the public and themselves in the dark.  Are they?

1. I wonder if most docs know that this is going on.  I didn't.  You can't speak out on something you dont' know is happening.

2. I'm sure things have changed, but i worked for a drug company in '91-2 and was present at meetings with the FDA and I can tell you they were anything but slaves to industry at that point.

3. The sworn purpose of the FDA is to protect the public health, to assure us that all the drugs on the market are proven safe and effective by reputable scientific trials.

And it works about as well as every other gov't agency.  Surprise!

"The cynic in me says nothing will change but atomized technology will just simply circumvent and make the FDA obsolete"

No clue what atomized technology is, but taking things out of the hands of gov't agencies sounds unlikely to be a bad thing.

[MachineGhost]

In a different world, one would expect to see medical professionals themselves speaking out against the FDA for keeping the public and themselves in the dark.  Are they?

Too much career risk?  The FDA is the most powerful agency.  They have a jack-booted, armed pig force and a lot of tooth-fanged shysters.  Even getting the FDA to follow the rule of law is a Herculean task.

Frankly, I think the sad fact is a vast majority of physicians are as ignorant as the masses.  They're too busy processing bureaucratic insurance paperwork/EMR and seeing a never-ending assembly line of patients for 10-15 minutes each to have any time for in-depth research; less any serious time for deep thought on how to reform the system and why would they even do that after accumulating six figures worth of student loan debt?  The smart ones get out early and do integrative and botique practice but that's not affordable by the masses nor covered by insurance, so its just more crony elitism.

[MachineGhost]

No clue what atomized technology is, but taking things out of the hands of gov't agencies sounds unlikely to be a bad thing.

That part is not bad, but the part where all the guilty parties get off without public shaming and imprisonment for their crimes against humanity is.  PS would argue its the system's incentives at fault, but I thought we don't tolerate "I was just following orders."

[MachineGhost]

Can't remember where I found this, but it is a good skit about marketing to doctors.  It's certainly not Daily Show caliber, so don't expect that!

https://www.youtube.com/watch?v=YQZ2UeOTO3I

[Benko]

If someone made any of you emperor how would any of you propose to fix any of this?

[stone]

If someone made any of you emperor how would any of you propose to fix any of this?

I've wondered whether it might work better to have a system of prizes rather than patents. So if a medicine were developed, then it would warrant a prize for the company that developed it. Then it could be freely manufactured by anyone just as with generic drugs. Perhaps the prize could be awarded  after five years based on how well the medicine had performed clinically.

The point would be to ensure that drugs were not marketed to anyone who wouldn't genuinely benefit from them. The vast cost of marketing drugs would be eliminated. There is currently a woeful connection between which drugs are profitable and which are most useful. For instance a new antibiotic would not be a money spinner in our current system because it would be kept in reserve and only used in rare cases so as to avoid resistance.
Under a system of prizes rather than patents, once a drug was developed, it would then be available at cost price. There would not be the tragic situation we now have where drugs aren't affordable for most patients who need them until the patent has expired (because most of the cost is the development cost, recouped via the patent). Also it would be companies that are capable at research who would get the funding stream to conduct more research. Sadly now that is not typically the case. Instead the funding stream goes to big pharma marketing giants who typically flounder at research and so buy up small research companies with drugs in development. Sadly those research companies then inadvertently get screwed up once under the command of the new giant owner.

A fund for such prizes might come from an international consortium such as medical insurers, the US NIH, the UK NHS and equivalent bodies across the world. In the UK we already have NICE deciding whether or not a medicine can be bought by the NHS ( https://www.nice.org.uk/about/what-we-do ). That is basically the same decision as deciding on a prize.
[img width=500]https://i0.wp.com/front.dadaviz.com/med ... 027249.png[/img]

[stone]

I just googled and saw that the "prizes rather than patents" idea is actually very well established:
http://en.wikipedia.org/wiki/Prizes_as_ ... to_patents

The Medical Innovation Prize Fund Act S1137 and S1138[edit]
The two bills proposed on May 26, 2011 by Senator Bernie Sanders would completely remove legal barriers to the manufacture and sale of generic drugs. The bills will give the government the right to set specific goals and direct research to certain areas of medicine. S1137 would apply to all prescription drugs, and S1138 is focused on HIV/AIDS medications. The bills call for both the government and private insurance companies to fund the "Medical Innovation Prize Fund". According to the S1137 bill, the innovation fund would create a fund of .55% of GDP, $80 billion of GDP based on 2010 numbers. S1138 calls for a .02% GDP fund for HIV/AIDS innovation prizes that amounts to about $3 billion a year.[5]

In a statement made at a subcommittee meeting, Senator Sanders said, "It simply blew me away — and would blow anyone’s mind away — that one drug, Atripla, costs $25,000 per year". He called this bill, “Fairly radical for the U.S. Congress.”? According to estimates, proponents of the bill believe that the costs of the prizes would be offset by the introduction of generic drugs and the reduction of monopoly power in the pharmaceutical industry. Sanders believes that these bills will save private insurers, Medicaid, and other government assistance programs money.[6]

One of the goals of the bill is to "de-link research and development incentives from product prices" along with getting rid of patents and what the bill's author asserts to be monopoly power. It aims to free research and development by proposing a possible "Open Source Dividend" element. This means that a percentage of the prize monies from the innovation funds would go to those persons or communities that allow access to knowledge, data, etc. to public domains and offer free access to patents.

Senator Sanders and other proponents of both bills[who?] assert that the prize funds will give incentives for manufacturers to seek innovative treatments for illnesses and diseases that are more important to society. In addition, they state that these funds will lower drugs prices, along with what they claim to be wasteful research and development costs.[5] This bill has been favored by Joseph Stiglitz.[citation needed]

The Bill & Melinda Gates Foundation have tried such a prize fund model. In their model, all applicants for funding from the Gates foundation must waive all claims to patents. “A World Health Organization (WHO) report, called 'Research and Development to Meet health Needs in Developing Countries', backs prize funds, saying it is a financially viable model”?[7]

In 2012 the two bills were referred to the committee level in the Senate. They have not been put to a vote in either the Senate or the House. In 2009-2010 only 3% of all bills proposed in the senate were enacted.[8]

[MachineGhost]

Very interesting, but unfortunately Bernie Sanders is a Socialist.  His ideals would fly in Congress about as well as Citizen's Dividend.

The real problem with America is it is in the business of being in business, not directly benefiting the public interest.  Any good to the public interest that does come out of rewarding shareholders is purely secondary.  Until this mindset changes, it is business as usual.

[WiseOne]

Frankly, I think the sad fact is a vast majority of physicians are as ignorant as the masses.  They're too busy processing bureaucratic insurance paperwork/EMR and seeing a never-ending assembly line of patients for 10-15 minutes each to have any time for in-depth research...

That is 100% on the money.  Everybody jokes about how medical school takes intelligent, interesting, motivated people and turns them into personality-less, boring dweebs.  You get to the point where you're afraid to think for yourself...it's pounded into you over and over that all truth comes from the FDA, pharmaceutical companies, malpractice lawyers, and multiple choice tests.

I'm very, very glad that I at least partially escaped this by sidestepping into research - now I'm the one who gets to write the multiple choice questions.  But when I go see patients or interpret studies I fall into the same mindset:  if you want to do something unconventional based on your own interpretation of the literature, then you put yourself into a difficult and scary position, risking everything from disapproval of colleagues to a lawsuit, and possibly for very little benefit.  The atmosphere at an academic center is a bit more permissive of such things so that progress can actually happen, but in private practice there is zero tolerance.

[dualstow]

John Oliver, Last Week Tonight. A friend mentioned this at dinner the other night so I figured that's where your link would take me. Now I have to watch it. Loved Oliver's piece on Net Neutrality, too. They should play his stuff in classrooms.

Can't remember where I found this, but it is a good skit about marketing to doctors.  It's certainly not Daily Show caliber, so don't expect that!

https://www.youtube.com/watch?v=YQZ2UeOTO3I

[MachineGhost]

MG, that video is beautiful (and sad).  Well worth the time to watch. 

Oh,and my doc only received $10.82 from a single drug company, so that was good to see!

openpaymentsdata.cms.gov

Forgot to mention that, thanks for bringing it up!

My PCP has received a whopping total of $90.72 in food and beverages since late 2013, but it's only 2013.  Welp, I guess it could be worse, right?

Sad thing is I really lack confidence in the system to even bother utilizing it to the full extent I could (for labs or prescriptions, certainly NOT "expert advice")... the disappointment and frustration just doesn't seem worth the emotional bipolarism, even though I'm always surprised when they are unexpectedly accomodating.  I always expect the worst to keep my expectations low, even though I'm unhappy with that state as well.  Ught.  On balance, I've had more bad experiences than good experiences since I became WIDE AWAKE.

Ignorance truly is bliss and I don't blame people that choose that path, even if I feel such pity for them for being such tools.

[madbean]

MG, that video is beautiful (and sad).  Well worth the time to watch. 

Oh,and my doc only received $10.82 from a single drug company, so that was good to see!

openpaymentsdata.cms.gov

The .gov link posted by Desert above is actually a lot better than the one MG posted last weekend. Whereas the other one showed only one line for my new Doctor with Johnson and Johnson as the payer, the government link appears to be itemized by individual payments and it showed a lot more payments from a lot more companies, including recent ones from AstraZeneca who just happen to be the makers of both the drugs she  prescribed me (Crestor and Nexium). 

openpaymentsdata.cms.gov