FREE Subscription
The World’s Most Popular Natural Health Newsletter   
 
 
POSTED BY
July 12 2005
1,453 Views

BROWSE BY CATEGORY

The FDA is Unable to Protect You!

 
Ritalin

Considering the Food and Drug Administration (FDA) has been fumbling the "safety ball" a lot lately, people, including the media, have begun paying closer attention to what the agency is doing ... or rather, not doing.

That could be why the FDA has been putting forth extra effort in its safety evaluation of drugs already on the market. Case in point: During a meeting of the FDA's Pediatric Advisory Committee, officials discussed adding new warnings to Concerta and other attention deficit and hyperactivity drugs containing methylphenidate (the active ingredient in Ritalin and other drugs).

According to a briefing document about the meeting, the review was prompted by reports of:

  • Hallucinations
  • Suicidal thoughts
  • Psychotic behavior
  • Aggression

And while Concerta's label already lists possible psychiatric side effects, it merely suggests the problems aren't serious or that the drug may only magnify already existing problems.

Other harmful effects associated with Concerta, per reports received by the FDA, include cardiovascular problems such as high blood pressure, arrhythmia and racing heartbeats; however, the FDA is unsure whether these effects are caused by the drug. (Let's hope not, considering patients filled 7.8 million prescriptions of Concerta just last year.)

The FDA plans to examine other stimulants used to treat ADHD, such as amphetamines and Straterra.

USA Today June 30, 2005



Dr. MercolaDr. Mercola's Comments:

As currently configured, the FDA is UNABLE to adequately protect YOU. They are more interested in protecting the interests of the drug industry -- it views the drug industry as its client, and the client is someone whose interests you represent.

Like it or not, that is the way the FDA is currently structured, and if you believe otherwise you are likely delusional.

Within the Center for Drug Evaluation and Research, about 80 percent of the resources are geared towed the approval of drugs and 20 percent is for everything else. Drug safety is a measly 5 percent. This speaks loads about their priorities. It is NOT about protecting you -- it is about approving drugs as quickly as possible so the drug companies can reap their profits.

Congress has not only created that structure but they have horribly worsened it with the Prescription Drug User Fee Act (PDUFA) by which drug companies actually pay money to the FDA so they will review and approve their drug. This creates an absolutely massive conflict of interest and fox-guarding-the-henhouse phenomena.

PDUFA was enacted 13 years ago and passed by Congress as a way of providing the FDA with more funds. This way, it could hire more physicians and other scientists to review drug applications so drugs could be approved more quickly.

You see, every day a drug is held up from being marketed to you they lose about $1 million to $2 million. Yes, you read it correctly, $1-2 MILLION for every DAY the drug is held up from being approved.

So the obvious incentive is to approve drugs as quickly as possible and not stand in the way of profit-making.

If you think for a moment that these superficial warnings on the drug labels are going to have any influence on the way they are prescribed, think again. This is merely a ploy by the FDA to appease the public and appear that they are doing their job. These warnings, however, have been proven time and time again to make absolutely no difference in prescribing rates.

It is my life's mission to serve as a catalyst to change this flawed system. But because I don't have $3 billion to invest in marketing like the drug companies, I can't do it without you! You can have a major impact on improving the speed at which the migration away from the current dysfunctional health care system, to one truly based on prevention and real cure, occurs by sharing the information in this newsletter with as many of your friends and relatives as possible.

BUT please be sure to do it wisely. Select a Mercola.com article that addresses their particular health struggle or concern, and then write a personal message in the e-mail as to why they should seriously consider the advice -- and why they should subscribe to the free e-newsletter. It is very easy to do with our button at the top of EVERY page on the Web site.

Please do NOT sign up any of your friends and relatives to this newsletter ... let them sign up on their own through your recommendation. If you sign them up without their approval it is a form of spam, and that would not be fair to them. They need to make the decision themselves to understand the truth regarding the health care system and learn more about the incredible alternatives they are likely unaware of.

And, by the way, here are some additional safe, effective treatments for attention deficit disorder:

Related Articles:

Non-Drug Treatment of ADD/ADHD

ADHD Drug May Harm the Liver -- Try These Three Safe Steps Instead

Maybe Attention Deficit Isn't the Real Problem

Did you find this article interesting?  Interesting Not Useful
Community Comments ( 0 )
Comment on this Article

 
Truste
 
Mercola