While the big trial known as PLATO found Brilinta was clearly superior to Plavix at preventing cardiovascular deaths globally, people in North America actually seemed to do worse on the new drug.

Could it be that we in the US eat a lot of garbage and chemically enhanced foods whole the rest of the world eats real food.

If Big Pharma doesn't kill us then the food industry WILL.

They already don't care what we think.

ware du iii sine up/?. tri als hav bean vaarty gud top me

 lets get the gitmo monkeys, all taliban and al-qaida  prisoners and donated them free of charge for the next round of swine and avian flu testing. and feed'em lots of pull pork sandwiches.

You gotta do what you gotta do . . .

Now, if we could just outsource the DISEASES these drugs treat, we'd be in great shape. A utopia of good health, unemployed doctors, fewer pharmacies and less "sick time" accrued through our jobs.

Yeah, sure...that'll happen.

Be talkin' to you..............Webrydr

What do you mean outsourcing guinea pigs? If you believe any of this BS from the Pharma industry you are a casualty. But what else do you think is the problem when slaves look to someone else for a magic pill, vaccine or GMO food that will make them live forever? (BARF)

If you put your life in someone else's hands from cradle to crave they will feed you anything because you will follow anything they spew.

Like I said SLAVES. You deserve anything they prescribe.

FDA approved Big Pharma drugs without effectiveness data

The information in question is known specifically ascomparative effectiveness data. And it is - or should be - a very big deal when it comes to deciding whether a drug should be approved and sold to the public.

--

Also, there are usually not data from large head-to-head trials comparing multiple treatments available when a medication first hits the marketplace. "Comparative effectiveness is taking on an increasingly important role in U.S. health care,yet little is known about the availability of comparative efficacy data for drugs at the time of their approval in the United States,"according to background information in the new JAMA study.

--

It's not like there's not money to come up with this information, either. In 2009, Congress allocated $1.1 billion of taxpayers' money to comparative effectiveness research.

Since its inception, APPLICANT OR SELF-FUNDED approval studies have been proven problem points in terms of safety, efficacy, labeling, regulating, and general credibility.

One possible solution would be for ALL applicant companies to kick-in to an 'approval fund' which the FDA would initiate their own independent studies from. This fund could also have access to DOJ criminal fines imposed upon these companies --as they have been fined in scores of case resulting in milti-BILLION $$ fines recently.

Now drug companies are seeking the LESS oversite and LESS regulatory atmosphere of overseas. Right in line with the funding & approval protocol above.

#BIGSURPRISE

Seems like it would be easier for the drug companies to pay off the doctors in these other countries to get the results and lack of side effects they want. Then later the side effects appear after the FDA approves the drugs for use in the USA.

Boy, those drug companies just love the good ole USA...NOT! Sending all these trials overseas may cut costs but it denies access of U.S. citizens (who are financially raped when the drug is put on the market) to medical trials of new drugs that could save a life. A precious life lost because a U.S. drug company out-sourced it's testing to some country that could, very well, have nothing in common life-style-wise with us (U.S.). I understand the need to reduce costs but I don't understand why it most always seems to be at the American citizens cost. You know, those same people who buy their product and create their wealth.

Drug companies suck big time. Their reputation, I thought, couldn't sink much lower and yet they've managed to slip yet again.

Pure greed. Profit-driven is one thing...putting human lives at stake to save a buck shouldn't be one of those "things".

Guinea pigs? That's easy....convicts.

I think one of the major points this article glosses over is that it is VERY difficult to show a benefit for a new drug in the milieu of all the available therapies in US patients. Take this medicine in the article for example--its used to treat heart attack patients. In the US, standard of care is a blood thinner, aspirin, a statin, a beta blocker, and possibly a stent. Pretty good therapy--you add on another drug and it may be difficult to show benefit even if that drug is superior to its currently approved analogue.

Should we be prescribing that drug if the benefit is that slim....mmm, that's a good question.

But the reason pharm companies do this is not all greed motivated

You know, if you are not suspicious of big pharma yet then you have not watched the stuff they put on TV advertisments. Listen to the disclaimers they start to run about halfway through the advertisment.

"A small number of DEATHS have been reported from the use of _______— but it has not been proven it came from the drug _________." Side effects include Stroke, Heart attacks, Heart stoppage, High Blood Pressure etc. etc. You should not use if you are alive. IF you or a loved one has died while using_____— call---------.

I LOVE the ones that say, "If you or a loved one had died while using________." How in hell are YOU going to call if YOU died?

.

One problem with testing overseas is that it is quite possible that the subjects really have not been informed of the ramifications of the drug test, so they are not making an informed decision about whether they would like to participate or not. In fact, one cannot be sure the people were even informed. The hospitals may be getting the money for running the test and using the people as unknowing guinea pigs.

Japan has a law that any medication must have been tested on Japanese subjects before being approved for use there. We need a similar law.

We're f--ked.

Currently, it takes about 800 million dollars to get a drug to market. Only about 19/20 drugs make it to the market. That means that every drug that makes it to the market actually cost about a little over 15 BILLION dollars to get that 1/20 there. In addition, the FDA is so restrictive that if one proves that a drug is good for disease/disorder X then the patent life for that drug is only good for the time that proof is accepted. In other words, if ten years later the company did another study (remember 800 million dollars) that the drug was also good for disease/disorder Z there would be no additional extension of the patent life of that drug....none. In addition, when drug companies go to socialized havens such as Canada and Sweden, the negotiating health officials there strongly intimate that if they want the drug and do not get it at there price then they will make it themselves. Often, there price they want and get is barely above production cost and in no way helps to cover research and development cost. Usually, the drug companies, out of fear of losing market share even though the market there is a loser anyway, usually give in. The net effect is that about 5% of the world...the U.S. consumer....pays for the R&D of drugs for the other 95%. I would prefer that the drug companies simply walk away from such unreasonable offers. If the negotiating country does indeed start producing that drug it does so without regard for patent rights. It is essentially pirating the drug. In my opinion, if a pirate off the coast of Somalia, is shooting and you and you shoot back and kill him then that pirates family should have no right to sue you in courts of U.S. jurisdiction. Considering that analogy, the U.S. should exempt private security firms from criminal and/civil prosecution in dealing with foreign pirate entities- including factories.

The scientific method, specifically the gold standard of double blind cross over placebo, if done ethically with informed consent and with repeatable verifiable data is independent of location of study done. So, if one location is cheaper than another the impetus of financial efficiency will win out as would be logically expected.

The real reason clinical trials are being done overseas is because of American trial lawyers. The cost of the liability insurance required in the U.S. is too high.