Friday, December 31, 2004

Failing FDA, Warning to Novartis and Greensboro's Involvement

The Associated Press through Yahoo reports that a pharmaceutical giant has been issued a warning letter by the FDA. The letter involves a drug called Deramaxx, 14 dead cats, FDA regulations and an animal testing facility in Greensboro, NC. Read more about it at:

Deramaxx is a COX-2 inhibitor and is in the same family of drugs as Celebrex and Vioxx. COX-2 inhibitor pain killers have come under fire lately as many have died due to complications from the drugs.

What happened to a doctors visit where you are prescribed drugs that have been tested to the Nth degree? I have a couple of pretty good inside sources that tell me that the drug companies hand out kickbacks to doctors and pharmaceutical outlets to push their drugs. That's right, push our drugs and we'll send you and your family to Hawaii or give you cash rewards. I have had this happen to me personally. I was taking Prilosec for some ulcers I had problems with. The drug was working wonderfully. When I moved back to Greensboro from NJ, I switched doctors and when my Prilosec ran out, had to go to the doctor to get checked for a new prescription. The doctor at Eagle Family Practice(Quaker Village) refused to give me a prescription for Prilosec and made me take Aciphex or nothing at all. The same doctor also made me go home with a severe hive outbreak, seeing if it would just pass. From my vast experience with this problem, I knew that would not be the case. I expressed that the only thing that has ever worked for my hive problem is a Epipen(epinephrine or adrenaline) shot and a shot of a common corticosteroid called Prednisone. He said no and sent me home. A few hours later, I had to go back and was finally given the shots that work. I was also billed for 2 level III office visits for this doctors incompetence. By the way, the Aciphex never worked. It actually made me sicker. I now see a different doctor.

Drug companies are forcing the FDA to push through drugs that are not thoroughly tested or ready to go to market. There is full coverage on this at Yahoo UK. Check out this interesting story:

In the article they say there "was testimony in November of a leading FDA drug reviewer, David Graham. Graham charged the agency repeatedly dismissed employees who questioned the safety of certain drugs on the market, particularly Vioxx."

The article also says, "The FDA says it supports a separate drug surveillance entity, whether it resides within or without the formal structure of the FDA.'This country does not have a system to monitor drugs after they're approved,' FDA's Woodcock said. 'Right now it's more of a passive system.' Few resources Woodcock notes the FDA has a small budget of around $5 million a year to monitor the performance of drugs. The Kaiser study that it ran to determine whether Vioxx posed cardiac risks was paid for under that budget, she said. A more powerful surveillance entity to monitor drugs and medical devices out on the market likely will cost taxpayers $150 million a year, says Woodcock. She cited numbers used recently in a bill on the matter sponsored by Sen. James Jeffords, I-Vermont."

Just yesterday there was a law suit filed against Johnson and Johnson by the parents of a 7 year old girl, who has come down with Stevens-Johnson Syndrome after taking the Motrin. She is now blind because Johnson and Johnson failed to warn of the possibility of the condition, something the company did include in the warnings before the drug went over the counter. This is the second lawsuit involving children's Motrin in two years.

All we as American citizens can ask for is safety in drug testing. We can try to rebuild the trust between drug companies and doctors and patients, but I feel it may be too far gone. I always read the small print on any info given to me, as well as, go to the internet and look up the drug companies website and drug info listed. Check out the side effects that these drugs can cause. A good resource for potentially harmful drugs is Weigh the risk and talk to other medical professionals if you feel you don't want to take those risks. We have to protect ourselves, because once again our government won't do it for us (which is their job at the FDA).
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