Approval process for drugs.
By Brian W. Vaszily
First, most new pharmaceuticals are developed to make drug companies and their shareholders more profit, not to offer new treatments and certainly not to offer cures. As I pointed out in another of my articles, "Spin and the Pharmaceutical Industry: Proudly Protecting Profits by Scaring You", only 15% of drugs approved by the FDA between 1989 and 2000 were cited as offering significant clinical advantage over drugs already on the market. That is, a vast majority of R&D dollars are spent on developing drugs that simply compete with existing drugs already on the market, so drug company A can try to rip sales away from drug company B. What's more, most drug makers won't even consider developing drugs for rare diseases because there is little promise of profit, despite the fact that at least 1 in 9 people in the United States suffer from at least 1 of the 6,000 known rare diseases.
Second, 70% of the funds for U.S. drug trials come from the drug companies -- and the majority of all funds now go to for-profit companies called contract research organizations (CROs). This is such a hot business to get into that over a hundred CROs have established themselves in the last decade. The majority of such research used to be performed by academic medical centers (AMCs), which as a result of the lost business are now making themselves more competitive against CROs to win back the drug companies. Now think carefully about this one. The drug companies are in effect hiring CROs and AMCs who must compete hard for their business. To retain the business of their customers -- the drug makers -- the CROs and AMCs must please them. Without knowing any more details, do you smell a conflict of interest? Do you suppose they skew clinical trials in the drug makers' favor to win their hearts and fat checks?
Well you don't have to suppose, and there's even more to it than that. According to the must-read book, "The Big Fix: How the Pharmaceutical Industry Rips Off American Consumers" by Katharine Greider, drug makers "increasingly insist on designing studies and controlling the raw data; some investigators may not even be allowed to see all the numbers. If results are unfavorable, drug makers are sometimes able to prevent them from coming to light..." Those "independent" organizations involved in drug research that are paid hefty sums by the drug companies are not, of course, about to start complaining about their clients' Big Brother eye and iron fists. Fat checks produce tight lips. On this note, Greider quotes Marcia Angell, M.D., the former editor of the New England Journal of Medicine, who told colleagues at a conference on conflicts of interest in research that, "Arm's-length relationships are a thing of the past, and financial arrangements are hardly limited to grant support."
But wait, there's still more. Back in 2001, editors of the most prestigious medical journals in the U.S., including The New England Journal of Medicine, enacted a policy giving them the right to refuse publication of studies sponsored by pharmaceutical companies -- meaning most such studies -- because they found that those companies were influencing the research results too extensively. This financial influence extended to the researchers who were writing the reports that are, in theory, supposed to be unbiased. By June 2002, however, all of these journals had relaxed this policy -- not on principle, not because things improved, but because things got worse: these journals could no longer find enough such experts without financial ties to the drug companies to keep their pages filled!
If you want it in pure layman's terms, though, here it is: An FDA-approved drug doesn't mean it's safe or effective. Not when it's the drug companies themselves, motivated entirely as they are by sales, dictating what will and won't be included and revealed at every stage of new drug studies. Sadly, these days all "FDA-approved" really means is that a drug is approved to reap even more ridiculously high profits for its manufacturer.
For good alternatives to drugs visit:
Excerpts from Dr. Mercola:
Fleetwood Mac star Stevie Nicks discussed the biggest mistake she says she ever made -- giving in to her friends and going to see a psychiatrist. He put her on the drug Klonopin, and the next eight years of her life were destroyed.
According to Nicks, if she didn't take it, her hands started to shake. She gained weight and felt as if she had a neurological disease.
As reported in the Daily Beast, Nicks said:
"Finally, in 1993, I'd had enough. I said, 'Take me to a hospital.' I went in for 47 days, and it made Betty Ford look like a cakewalk. My hair turned gray and my skin molted. I could hardly walk. You can detox off heroin in 12 days. Coke is just a mental detox. But tranquilizers -- they are dangerous. I was terrified to leave, and I came away knowing that that would never happen to me again."
According to the latest statistics from the Kaiser Health Foundation, the average American, aged 19 to 64, now takes more than 11 prescription drugs!
The elderly generally take more medicines than younger folk—in the US, the average senior fills more than 31 prescriptions per year.
Sadly, there are literally millions of people who, like Stevie Nicks, suffer the ravaging side effects of drugs they didn't need in the first place—drugs that were supposed to "help" them in some way, but in reality cause problems far worse than the original concern.
Opioid painkillers alone — opium-like drugs that include morphine and codeine — now claim more than 13,800 lives each year. This means prescription painkillers have surpassed both heroin and cocaine as the leading cause of fatal overdoses.
In the first quarter of 2008, fatalities from adverse drug reactions accounted for 23 percent of all adverse reaction reports!
If that's not a wakeup call, I don't know what is.
Naturally, some drugs are far riskier than others. Chantix, for example, accounts for more adverse reaction reports, including deaths, than the ten best-selling brand name drugs combined! It even out-harms the addictive troublemaker oxycodone, a potent pain medication.
The greatest travesty here though is that Chantix is actually intended for use in healthy people to help them quit smoking! If that's not insane, I don't know what is.
Disease can only be resolved by addressing its root cause.
Investigation of dangerous medical device implants reveals most have never been tested for safety
Wednesday, April 04, 2012 by: Jonathan Benson, staff writer
(NaturalNews) Did you know that the vast majority of medical devices on the market today have received approval from the U.S. Food and Drug Administration (FDA) without ever having been properly safety tested? A thorough investigation by Consumer Reports has revealed that the medical device approval process is a pay-for-play sham that is putting millions of people at risk of serious injury or death.
Confirming two earlier studies that were published in the Journal of the American Medical Association (JAMA) and the American Journal of Therapeutics (AJT) back in 2010, the Consumer Reports findings expose the FDA's complete lack of oversight of the medical device industry. Rather than require that medical device manufacturers prove the safety of medical devices prior to their approval, the FDA instead extorts user fees in exchange for the agency's seal of approval.
"For most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and pay the Food and Drug Administration a user fee of roughly $4,000 to start selling a product that can rack up many millions of dollars in revenue," says Consumer Reports. "Often, the only safety 'testing' that occurs is in the bodies of unsuspecting patients."
In 1998, the FDA ruled that medical device distributors were no longer required to report adverse events, including death, to the agency, which means there is no way to know just how many people are being injured or killed by medical devices. And if that is not bad enough, the FDA is now trying to work with Congress to enact new laws that would make it even easier for medical device manufacturers to get their products to market without having to first prove their safety.
"Because so many medical devices are not being held to a higher safety standard, people are dying who wouldn't otherwise die and who don't have to die," Diana Zuckerman, president of the National Research Center for Women & Families, is quoted as saying by USA Today. "People are being harmed who don't have to be harmed".
When also considering the fact that the U.S. Supreme Court ruled back in 2008 that medical device manufacturers could not be sued for injury or death caused by their FDA-approved products, it becomes disturbingly obvious that using medical devices or getting them implanted into your body is like playing Russian Roulette with your health.