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Author: Kim Evans - Organic Lifestyle Magazine Author: Kim Evans - Organic Lifestyle Magazine

Clinical Trials and Scientific Studies

Clinical trials and scientific studies are held as the gold standard when it comes to health care, so how credible those trials and studies are ends up being a very important question. The truth, as it turns out, might surprise you.

The medical establishment likes to look at their studies as factual, evidence driven, and done with an impartial eye. But the truth is, the results of research studies can have multi-million or multi-billion dollar consequences for drug companies, so they can be about as biased as you can get.

It makes more sense when you understand that the drug companies with many millions or billions at stake are often funding the researchers or funding the universities for which the researchers work. And, of course, if the researchers’ studies produce the “right” results, they are more likely to continue to receive funding. Researchers who don’t get enough grant money from big pharmaceutical companies are likely to lose their university jobs. For some researchers, that can be reason enough to play along.

Playing along can mean a number of things. At its worst, playing along can result in complete fabrication or manipulation of the data and results.

It wasn’t long ago that Hwang Woo-Suk, South Korea’s once highly esteemed researcher, claimed a major breakthrough in stem cell research and his results were also published in a prestigious, peer-reviewed publication. It was later found that he fabricated the data, for which he publicly apologized. While his fraud made headlines around the world, the crime might not be as rare as you think.

In 2008, one in fifty scientists admitted they had fabricated, falsified or “doctored” a research study; that number is generally regarded as low since these researchers have an interest in keeping their frauds a secret. When these same scientists were asked if they knew a colleague who had fabricated the data or results, about one in seven said they knew someone who had done just that.

Questionable research practices fall below outright falsification of data and were found to be even more prevalent. When scientists were asked, about one in three admitting to having used questionable research practices; again, the number skyrocketed when asked if they knew a colleague who had. About seven out of every ten scientists said they knew a colleague who had used questionable research practices.

Questionable research includes practices like “changing the design, methodology or results of a study in response to pressures from a funding source” or cherry-picking the results for publication. To the FDA, the latter is even acceptable.

In fact, by FDA rules, pharmaceutical companies can conduct as many clinical trials as they want, and send only the favorable results to the FDA for review. To help you read between the lines, this means drug companies can bury the negative results of clinical drug trials so that you and your doctor Clinical Trials never know about them.

Eli Lilly was accused of hiding the risk of suicide and suicidal tendencies with their drug Prozac, a drug now accepted to increase suicidal risk. A Harvard psychiatrist alleged that during the clinical trials those with suicidal tendencies were asked to leave the study, so their results were not counted. The Harvard psychiatrist was able to produce Eli Lilly internal documents to support the accusation.

Internal documents also surfaced to support the accusation that Eli Lilly knowingly hid the risks of their drug Zyprexa. A former FDA official even testified in court that the drug giant hid the risks for the purpose of insuring profits.

Questionable research practices can also include tweaking the results to make them seem more definite than they originally were, ignoring conclusions that don’t meet the study’s needs, and concealing conflicts of interest.

Depending on whose numbers you trust, incidences of scientific fraud in the U.S., as counted by government confirmed cases, occur with one out of ten scientists at the high end, or at the low end, with one out of every hundred scientists. Either way, they’re high numbers, especially when you consider that millions of people trust this information then put unnatural chemicals inside their bodies.

Properly prescribed pharmaceutical drugs have been found to kill 100,000 Americans and “seriously injure” another 2.1 million each year, and one has to wonder how much pharmaceutical and scientific manipulation and outright fraud is responsible.

To add to the dog pile, drug companies have been found to stoop to all sorts of tricks.

Merck was caught disguising in-house authors as independent researchers. To accomplish this, Merck wrote a key study used to popularize the now infamous Vioxx then paid a researcher to put his/her name on it.

In relation to Vioxx, the Wall Street Journal reported that “a prominent Massachusetts anesthesiologist allegedly fabricated 21 medical studies that claimed to show benefits from painkillers like Vioxx and Celebrex.” The studies were published in anesthesiology journals between 1996 and 2008.

Another tactic of the drug companies is to intimidate the scientists. Drug companies have been known to pressure researchers, even scientists at the federal agency that is supposed to regulate them.
Drug Overdose Pressure at the FDA to bow to the interests of their financiers, the drug companies, has gotten so out of hand that scientists at the agency recently wrote Congress and then president-elect Obama about the problems. They talked about being forced to “change their opinions and conclusions,” which is a pretty weighty accusation.

The medical world’s insistence that their drugs are both effective and safe, based on their “unbiased, evident-based” research and clinical trials, no longer sounds so reassuring, does it? Profit-driven would be a more accurate description.

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Obscene Drug Profits

Recently, a couple of federal budget analysts from Washington, D.C., wondered about the profits in pharmaceutical drugs and came up with some interesting figures. Turns out that to purchase the active ingredients for many drugs is often pennies, while a hundred dollar plus price tag is passed on to consumers.

They found that 100 tablets of 20 mg Prozac costs the consumer about $247.47, while the active ingredients only cost $0.11. Yes, that’s right: eleven cents for all one hundred tablets. It’s a 224,973 percent mark-up, a profit margin most business owners dream of – but could never get away with.

Even more profitable, Xanax customers regularly pay $136.79 for a hundred 1 mg tablets, while the active ingredients cost just under three cents. The mark-up is an unbelievable 569,958 percent.

Of course, the active ingredients aren’t the only expense in making these chemical concoctions. Drug companies regularly pay more than a million dollars per drug to their regulators, the FDA, in order to put their drug on the market. Exorbitant fees, which all too often beg the question about any real regulation taking place when the regulatory agency is funded by those it’s supposed to be regulating.

If you were regulating the person writing your paychecks, how hard would you be on them? Maybe, perhaps, you’d cater to them? Catering is exactly what a group of FDA scientists told Congress was happening at the drug approval agency in a letter last October.

In connection to the letter the New York Times reported, “The scientists have documentary evidence that senior agency managers ‘corrupted the scientific review of medical devices’ by ordering experts to change their opinions and conclusions in violation of the law.”

Wow, change their opinions and conclusions. Could this be done in the name of profits, not protection or health? And if this is done at the FDA, the regulatory agency, how credible are studies funded directly by drug companies and their paid researchers, on staff or university bound?

Then, of course, there’s the advertising expense.

A 2008 study found that pharmaceutical companies spend about 24 percent of their sales dollars on advertising and promotion, in contrast to just 13.4 percent on research and development. This promotional expense includes direct to consumer advertising and the continual wooing and “educating” of doctors – their front line sales force.

solution to anything that ails the body. They’re being hit with the message in-person, from drug reps, about 5 times each working day.

Combine that with the fact that drug companies are funding professors at medical schools, the universities themselves, and university bound researchers, and you’ll get an even clearer picture of why medical doctors think drugs are the only viable avenue in health care.

At Harvard Medical School, about 1,600 professors and lecturers confessed earlier this year that they or a family member were taking pharmaceutical dollars. They admitted this after being required to, upon pressure from students protesting the undue role of the drug companies in their education.

Of course, these dollars play a large role in determining what is taught and studied, what is not, and exactly how the findings are presented. UCSF researchers took a look at 192 published studies comparing different drugs and determined that the source of funding for a drug trial greatly influenced the outcome. They found that if the results favored a drug it was “about 20 times more likely” to have been funded by the manufacturer of that drug.

Now, factor into the equation that the pharmaceutical industry spends more to lobby government officials than any other sector, and it’s all too clear why drugs are the dominant health care solution promoted today.

A 2005 investigation by the Center for Public Integrity found that in the seven years prior, the pharmaceutical and health products industry spent more than $675 million to lobby for the influence of public officials, saying it’s lobbying operation is “the biggest in the nation” and that “no other industry has spent more money to sway public policy in that period.” When you combine campaign contributions with those lobbying costs, the drug industry was outdone only by the insurance industry, with which it has close connections.

So if you were wondering where all of those excessive drug profits were going, now you know. They’re buying influence with the FDA, media, doctors, medical schools, professors, researchers and last but not least, politicians. They’re all on the payroll with plenty of extra money to go around. Wonder what each of those influential sources will prescribe for you?

Resources:

Obscene Drug Mark Ups

Reprinted with permission from NaturalNews.com