EU Rejection + Patient Deaths = FDA Approval of Another Dangerous RA Drug

November 19, 2013
Category: Reform Healthcare

rheumatoid arthritisRheumatoid arthritis is a painful condition. But FDA-approved killer meds are not the answer.

We told you earlier this year how dangerous a new class of anti-inflammatory drugs called TNF-alpha blockers can be. The best-known drugs in this class are Enbrel and Humira, which are used to treat juvenile rheumatoid arthritis, Crohn’s disease, and other inflammatory diseases for which they are not approved.

The more common non-steroidal anti-inflammatory drugs (NSAIDs) are no picnic either. A recent study showed that patients who take NSAIDs have a 90% greater likelihood of dying from all causes, and many NSAIDs are required to carry a Black Box Warning.

Pfizer’s new anti-inflammatory drug, Xeljanz (tofactinib), caused four patient deaths before it even hit the market. One death was caused by respiratory failure, and one by acute heart failure. Tofactinib is a drug of the janus kinase (JAK) inhibitor class. It’s currently FDA-approved for the treatment of rheumatoid arthritis (RA) and is being studied for treatment of psoriasis, inflammatory bowel disease, and other immunological diseases, as well as for the prevention of organ transplant rejection. Unfortunately, it causes such side effects as infections, shingles, lymphoma, and stomach ruptures.

The European regulatory agencies rejected Xeljanz twice on safety grounds: it “had major concerns about the overall safety profile of Xeljanz” and was “of the opinion that the benefits of Xeljanz did not outweigh its risks.”

After US approval, Xeljanz hit the ground running, and commanded a shocking $2,000 per month price tag when it was initially released. This was despite the bad buzz about Xeljanz—even from doctors—before it even hit the market.

FDA-approved medications kill 200,000 Americans every year. How do dangerous drugs like Xeljanz keep getting approved? Look no further than the crony capitalist system in which the FDA and Big Pharma have countless conflicts of interest. And don’t forget the FDA’s recent “pay-to-play” scandal we told you about last week.

There are other reasons as well. The pharmaceutical industry is outsourcing its clinical trials to developing countries, where it is easy to manipulate trial outcomes. AstraZeneca, for example, is outsourcing dangerous placebo-controlled drug trials to countries like South Africa, which critics are calling unethical. The developing world has little access to modern medicines, so sick patients are willing to take a risk on dangerous studies—hoping against hope that (a) they’re not in the placebo group, and (b) the drug actually does some good. Additionally, there is rarely access to post-study treatment—even if a study participant is given a life-saving drug, it is taken away after the trial.

“The FDA prefers placebo-controlled trials,” says Lainie Ross, MD, PhD, a pediatrician at the University of Chicago, “because they are ‘neater,’ need fewer subjects, [with] easier endpoints.” Big Pharma prefers placebo-controlled trials as well, because the new drugs don’t have to be more effective than drugs already on the market—just better than nothing at all.

RA and other painful conditions are hard to live with. RA is believed to represent an infection of some kind, but there are many natural treatments that seem to help, including foods and supplements that boost the immune system, kill pathogens, or work in ways not completely understood such as green tea extract. For some powerful and safe natural remedies for pain, see our recent article on the subject.

7 responses to “EU Rejection + Patient Deaths = FDA Approval of Another Dangerous RA Drug”

  1. Irena Franchi says:

    I’m opposed to dangerous drugs.

  2. Linda McDowell says:

    It’s too bad the FDA doesn’t ban Water Fluoridation because the chemical Fluorosilicic Acid, commonly used in water fluoridation programs is linked in causing Bone Disease as well as most of our health problems in this country. All one has to do is Google “Fluoride” and any disease, the information available is astounding. This chemical is so toxic it is unlawful to dump it in the environment but it is okay for us to drink it first and destroy our bodies as it passes though before going into the environment.
    http://www.cdc.gov/niosh/ipcsneng/neng1233.html

  3. Michele Martin says:

    I have always used natural ways of dealing with illness and even headaches. Then I got RA. You obviously don’t understand this disease and how many of us have tried everything natural, including lots of prayer. The pain is much worse than you can imagine and the deformities of the body are nothing to take lightly. I have had 3 surgeries to date and have 2 more scheduled. One December 5. Don’t confuse people with things you don’t know enough about. Some with Rheumatoid Disease will be led to believe they shouldn’t treat their disease and will suffer more greatly by not treating it properly in the beginning stages. Please take a look at the website RA Warrior for great information about the “real” Rheumatoid Disease.

    • I certainly understand and understand the pain and disability caused by RA. Just taking an OTC natural remedy may give a little pain relief but won’t get the real causes. As an integrative physician, I have had success in a number of auto-immune disease, including the ones this class of drugs are used to treat, and have gotten RA and other patients off these medications. But it takes a multipronged approach under the care of an experienced integrative or functional medicine physician or practitioner (see http://www.integrativemedicineconsortium.org.) It also requires commitment on the patient’s part to change their diet (if necessary) and implement other changes. Sometimes transitional medications are necessary, particularly if infections are involved, (see http://www.theroadback.org they usually are. Unfortunately, many people feel taking a drug is just easier, no matter how toxic and dangerous.

    • Yes I do understand the pain of RA. I put myself on my own protocol and took myself OFF the doctors meds because of what they were doing to my liver. I have followed the protocol from the “Inflammation Nation” book and have gotten control over my flares for the past 8 years. I did discover that you can take TOO much fish oil and have reduced my intake in half along with the borage oil. You can not PAY me to take the drugs the doctors have said would help because I have found another way!

  4. Diane Adams says:

    If there are those that have tried everything and are willing totake the risk with a dangerous drug from Big Pharma, even one banned in other countries, then their doctors can get them on the list to be prescribed the drug. Other than that, the ones who have not tried everything begin with the lesser of the possible evils in drugs.
    The outsourcing of tests is inhumane. Period.
    Greed. Cruelty. Dishonesty. Incompetence. All attributes of Big Pharma and the FDA that allowed itself to be bought into the equation, at risk of the people it is to protect from Big Pharma.

  5. wvh says:

    Why hasn’t there been a congressional investigation of the FDA and the pharmaceutical industry and all the collusion and conflicts of interest between them? And why hasn’t there been an investigation of what IMO amounts to open bribery in the pay-to-play matter and for fast tracking new meds? Is congress in on the collusion? Are they taking bribes too? Something needs to be done about this but it seems like no one has the guts to do it.

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