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FDA

Selective serotonin reuptake inhibitors in childhood depression – (06-01-04)

February 17, 2013 by James Bogash

Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data

This issue has really blown up lately. With the increasing use of psychoactive medications to our children (which I think is absolutely unacceptable except in the most severe cases) the safety of this class of medications is not known. It turns out that many of these drugs had studies done that showed a negative risk-benefit ratio with some studies showing an increase in suicide rates in medicated kids. But these studies were conveniently never published which led to a favorable outcome when one looked ONLY at the published studies. While this type of shenanigans is fine for GM or Honeywell or some other big company, this is our future we are messing with.

For those of you reading this with small children at home–could you possibly imagine giving your child a powerful drug that affects the mind when we do not know what the long term damage may be? Or worse yet, the damage is known but hidden? Where is this glorious FDA that we want to put in charge of our vitamins?

(editorial on this topic The Journal : Back Issues Back Issues).

US junior doctors found to be ignorant of drug companies’ tactics.

Okay. Most educated people on the street know or have some idea that the pharmaceutical companies use money and gifts to influence the prescribing behavior of doctors, and that these methods are very effective. However, residents were unaware of this behavior? Huh? No wonder it’s effective.

bmj.com Spurgeon 328 (7447): 1032 –

Read entire article here

 

Filed Under: Drug Research Tagged With: childhood depression, FDA, serotonin reuptake inhibitors, vitamins

Inactivated Intranasal Flu Vaccine and Risk of Bell’s Palsy – (03-22-04)

December 30, 2012 by James Bogash

Inactivated Intranasal Flu Vaccine and Risk of Bell’s Palsy

For those of you unfamiliar with Bell’s Palsy, it is paralysis of the facial nerve which results in one half of the face drooping. This damage can be permanent in some instances. Usually takes several months to resolve. Here we have a vaccine for the flu–which, unless you are immunocomprimised in some way I cannot see the rationale for getting–gives you a 19 times greater risk of developing Bell’s Palsy.

For those of you really interested, I have included a piece done prior to release of the vaccine, when the manufacturer was aware of an increased risk of Bell’s Palsy but downplayed the risk to the FDA. Some much for government agencies protecting the public…

NEJM — Use of the Inactivated Intranasal Influenza Vaccine and the Risk of Bell’s Palsy in Switzerland.

Read entire article here

Filed Under: Influenza, Vaccination Tagged With: Bell's Palsy, FDA, influenza, Intranasal Flu, Vaccine

How safe is ultrasound on the fetus? – (04-22-04)

December 16, 2012 by James Bogash

FDA warns against commercial prenatal ultrasound videos

By now, most of us have seen the 3-D pictures of developing fetuses. Kind of neat. But wait–the FDA puts out a warning about these, saying that “Ultrasound is a form of energy and can’t be considered harmless, even at low levels, it says.” Really? Then why the excessive use of ultrasounds as a standard approach in all pregnancies? Should we not warn against those as well?

Keep in mind that there has NEVER been any studies about the safety of ultrasound on the fetus. We have seen studies that suggest that ultrasound may give a tendency for the child to be born left handed–suggesting that the ultrasound is not as benign as we would like to think. And, considering that ultrasound rarely changes the outcome of a pregnancy, should we not be questioning the routine use of ultrasound in pregnancies?

bmj.com Tanne 328 (7444): 853 –

Read entire article here

Filed Under: Healthy Pregnancy and Women's Health Tagged With: FDA, fetus, prenatal ultrasound

LACK OF PROTECTION WITH REGARDS TO ANTIDEPRESSANTS AND CHILDREN – (10-20-04)

October 11, 2012 by James Bogash

Failing the Public Health — Rofecoxib, Merck, and the FDA

By now everyone has heard that Merck pulled it’s blockbuster drug from the market. Not a big surprise, since it was mentioned here at least 3 years ago (October 2001, Research Updates) that there were cardiac issues with the selective COX-2 inhibitors. There was clearly a failure of the FDA to protect the public in this situation. But we have also recently seen the same lack of protection with regards to antidepressants and children. It is the almighty dollar that rules here, but the general public still believes that the FDA is really out there with our best interests at heart. So, they pull ephedra, possibly linked to a handful of deaths when used INAPPROPRIATELY, but take years to pull off drugs, used APPROPRIATELY, off the market.

NEJM — Failing the Public Health — Rofecoxib, Merck, and the FDA

Read entire article here

Filed Under: Drug Research Tagged With: cardiac, COX-2, ephedra, FDA, Merck, rofecoxib

TNF-ALPHA IS BETTER FOR BONE HEALING AND FIGHTING CANCER – (09-24-03)

September 30, 2012 by James Bogash

Impaired Fracture Healing in the Absence of TNF-alpha Signaling: The Role of TNF-alpha in Endochondral Cartilage Resorption

It is quite common for drugs to be developed and marketed that affect certain biochemical pathways before we fully understand these pathways. This is evidenced by the withdrawal of many medications after they are approved by the FDA. Of particular concern for me is the new drugs that block TNF-alpha being used for rheumatoid arthritis, Crohn’s and psoriasis.

While I understand that many patients with these conditions are suffering with their symptoms, I know that many of these patients have not exhausted (or, in many cases, even attempted) natural approaches. TNF-alpha is now known to be an integral component of bone healing and formation, fighting off cancer and fighting off infections. Blocking this messenger may yield more long term problems than it solves.

Impaired Fracture Healing in the Absence of TNF- Signaling: The Role of TNF- in Endochondral Cartilage Resorption.

Read entire article here

Filed Under: Arthritis, Tissue Necrosis Factor (TNF) Tagged With: arthritis, Endochondral, FDA, Psoriasis, rheumatoid, TNF-alpha

HIDING THE EVIDENCE OF ADVERSE DRUG EFFECTS – (07-09-07)

April 6, 2012 by James Bogash

Dangerous Deception — Hiding the Evidence of Adverse Drug Effects

For many years, mainstream medicine has hidden behind the validity of their approach using pharmaceuticals that were based on clinical trials. The facade has come crashing down in so many ways–funding biases, canceling negative trials, not publishing negative trials, data manipulation… The list has become so extensive as to question every single trial. Is there really ANY validity to intervention trials? I personally lean towards basic physiology trials.

No one has financial interests in these types of studies and bias is not as likely. Funding usually comes from government or universities w/ no goal for a positive or negative outcome. This is a very interesting article outlining the deception that occurred with the study and approval of Bayer’s drug aprotinin and how they hid negative effects from the FDA when they requested approval.

Read entire article here

 

Filed Under: Drug Research Tagged With: Adverse Drug Effects, Bayer’s drug, clinical trials, FDA, physiology trials

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