Preemption pharmacuticals
Preemption: Pharmaceuticals
For thousands of years humans have carried forward information about plants that have medicinal value. This intelligence has helped us survive and populate the earth. About 100 years ago the first efforts at manufacturing drugs to fight disease and promote well being began. When I was born the only medicine doctors really had at their disposal was sulfur drugs. Now new drugs are born continuously. Pharmaceutical companies are under intense pressure to create the next “blockbuster” before the patent on the last expires.
Now we rely upon the FDA to monitor the natural motivation of the industry giants to get their products in the market with a kickoff of massive consumer advertising. The FDA doesn’t have the budget to do its own testing and must rely upon the representations of the very companies that stand to gain from a quick approval.
The problem with these new drugs is that they are not born with the intelligence and communication abilities the cells in our bodies possess. If you take an antibiotic it kills the good bacteria as well as the bad since it doesn’t know how to “talk” to the white blood cells that know the difference. We end up eating yogurt for a couple of weeks after the killing takes place. Unfortunately the downside of taking many of the new drugs is much more significant than having to eat some yogurt.
Once on the market consumers are exposed to advertisement calculated to motivate them to suggest the drug’s use to their treating physicians. Pharmaceutical reps have already met with the doctors and deposited free samples. Success! Now it is merely a matter of routine prescription renewal to lock in the market share.
This system gives rise to over half of the medicines approved by FDA later requiring stronger warnings for patients or being removed from the shelf altogether.
Ironically, the cause for many of the more dangerous drugs being reexamined is brought about by plaintiff’s trial lawyers who take up the cause for their clients. The department with FDA in charge of follow-up of approved drugs has little or no power to enforce its determinations. Since fighting a technical battle with some of industry’s largest giants is too much for the common man, the lawyers are handling the litigation on a contingent fee and are covering the costs up front. If the lawyers are wrong, they eat the cost and receive no fee.
Now the last vestige for protection outside of efforts by the out-gunned FDA is under attack by legislation preempting litigation if the drug is approved by FDA, even if it is proved that the approval was based on false and misleading data presented by the manufacturer to FDA.
We must not allow this to happen.
For thousands of years humans have carried forward information about plants that have medicinal value. This intelligence has helped us survive and populate the earth. About 100 years ago the first efforts at manufacturing drugs to fight disease and promote well being began. When I was born the only medicine doctors really had at their disposal was sulfur drugs. Now new drugs are born continuously. Pharmaceutical companies are under intense pressure to create the next “blockbuster” before the patent on the last expires.
Now we rely upon the FDA to monitor the natural motivation of the industry giants to get their products in the market with a kickoff of massive consumer advertising. The FDA doesn’t have the budget to do its own testing and must rely upon the representations of the very companies that stand to gain from a quick approval.
The problem with these new drugs is that they are not born with the intelligence and communication abilities the cells in our bodies possess. If you take an antibiotic it kills the good bacteria as well as the bad since it doesn’t know how to “talk” to the white blood cells that know the difference. We end up eating yogurt for a couple of weeks after the killing takes place. Unfortunately the downside of taking many of the new drugs is much more significant than having to eat some yogurt.
Once on the market consumers are exposed to advertisement calculated to motivate them to suggest the drug’s use to their treating physicians. Pharmaceutical reps have already met with the doctors and deposited free samples. Success! Now it is merely a matter of routine prescription renewal to lock in the market share.
This system gives rise to over half of the medicines approved by FDA later requiring stronger warnings for patients or being removed from the shelf altogether.
Ironically, the cause for many of the more dangerous drugs being reexamined is brought about by plaintiff’s trial lawyers who take up the cause for their clients. The department with FDA in charge of follow-up of approved drugs has little or no power to enforce its determinations. Since fighting a technical battle with some of industry’s largest giants is too much for the common man, the lawyers are handling the litigation on a contingent fee and are covering the costs up front. If the lawyers are wrong, they eat the cost and receive no fee.
Now the last vestige for protection outside of efforts by the out-gunned FDA is under attack by legislation preempting litigation if the drug is approved by FDA, even if it is proved that the approval was based on false and misleading data presented by the manufacturer to FDA.
We must not allow this to happen.
http://www.bailey-law.com/lawyer-attorney-1207093.html
