Do you know what it takes to design, test, and get approval for a new drug?!
Question: Many of you have some gripe with doctors, pharmaceutical companies, and generally any person who actually can treat your illnesses, but have any of you ever actually thought about some of the preposterous claims and accusations you make? Have you ever taken the time to learn about how drugs are made? Or do you just feel the need to belittle modern medicine?
But back to the main question, Do you even know what it takes to design, test, and get approval for a new drug?
I doubt I'll even have one responder who does.
0 seconds ago - 4 days left to answer.
Answers: Many of you have some gripe with doctors, pharmaceutical companies, and generally any person who actually can treat your illnesses, but have any of you ever actually thought about some of the preposterous claims and accusations you make? Have you ever taken the time to learn about how drugs are made? Or do you just feel the need to belittle modern medicine?
But back to the main question, Do you even know what it takes to design, test, and get approval for a new drug?
I doubt I'll even have one responder who does.
0 seconds ago - 4 days left to answer.
Yes
it takes about 12 years average for an experimental drug
to go from the lab to becoming a medicine
Only five in 5000 compounds that enter preclinical testing even get to human testing
one of five drugs tested on people is approved.
ok this will be a longgg answer lolll
1.To design a drug you have to find out EVERYTHING known about the disease and remedies for it, you have to test effectivness,consider financial issues, you have to find lead compounds which are are compounds that have some activity against a disease, you gotta isolate the molecular basis for the disease[what protein or nucleotide the drug will bind to..complicated to explain], then you have to refine the drug[create more drug activity less side effects]
2.a pharmaceutical company conducts laboratory and animal studies to show biological activity of the compound against the disease they are targeting, and the compound is tested for safety. These tests take like three to four years
3.After completing preclinical testing, the drug company files an IND[investigational new drug application] with the FDA to start testing the drug on people. The IND becomes effective if FDA does not disapprove it within 30 days. The ind shows results of experiments done before, by who and where and how the new studies will be conducted,the chemical structure of the compound,how we think itl work in the body,any TOXIC effects found in the animal studies, n how the compound is manufactured. And then the IND has to be reviewed and approved by the institutional review board, where the studies will be conducted has to be approved, and then on top of that progress reports on clinical trials have to be submitted to FDA.
4. is the actual clinical trials
Phase 1-takes about a year and involves like 20 to 100 healthy volunteers. The tests study a drugs safety,including what the safe dosage is.The studies also determine how a drug is absorbed, distributed, metabolized and excreted and how long the process takes in the body [the duration how long itl last]
Phase 2-this is controlled studies of like 100 to 300 volunteer patients WITH THE DISEASE to test the drugs effectiveness... it take about two years.
Phase 3-lasts about three years and involves about 1000 to 5000 patients in clinics and hospitals...doctors monitor patients real closely to determine how well the medicine works and identify bad negative reactions to the drugs.
5. New drug application [NDA]
after all three phases of clinical trials are done, the drug company analyzes all of the data and files to see if the drug was shown to be safe and effective. The nda has to give all of the scientific information that the drug company has. The application usually has like 100,000 pages or more.The FDA is allowed six months to review an nda. Usually the period between the first submission of an NDA and final FDA is much longer like an average of around 30 months
6. FINALLY APPROVAL [if you get it]
Once FDA approves the NDA, the new medicine becomes ok for doctors to prescribe. The company has to keep submitting reports to FDA, including any cases of negative reactions and records to prove the drug is being manufactured with QUALITY. For some[alot of] medicines the FDA demands more studies [phase 4 trials] to determine the long term effects of the drug.
My question is if it is sooo regulated then WHY are there so many deaths linked to Vioxx, Chantix, Prozac and many other drugs?
If they are so safe why do many have a page full of side effects?
Why are there so many class action suits against them?
Why are they constantly having to pull drugs from selling?
Why do they have to give you a bunch of different drugs to counteract the effects of the others?
and why did the one company try to kill my neighbor after he came up with the missing chemical for the one thing they were trying to formulate?
I would list the suits from findlaw but I don't have an account any more.
http://www.newstarget.com/012119.html
http://www.prozactruth.com/
New England Journal of Medicine is even doing many articles about how drug companies are hurting the public for the sake of making a profit. THIS ONE is general
Under the current model, drugs are rapidly evaluated before approval and are often aggressively marketed afterward. Direct-to-consumer advertising can rapidly expand the use of new drugs to include patient groups that were sparsely represented in pre-marketing evaluations. The centerpiece of the CDER post-approval safety system is the Adverse Event Reporting System (AERS); in this system, patients or health care professionals submit reports of adverse events thought to be related to drug administration. Although this collection of voluntarily submitted case reports represents the weakest form of epidemiologic evidence, many drugs have been appropriately relabeled, sometimes with black-box warnings, or withdrawn from the market on the basis of AERS evidence.
CDER lacks a systematic approach to identifying possible pre-marketing drug-safety problems and translating them into high-quality post-marketing studies. Without an organized system to identify potential safety signals, the studies needed to resolve them may not be performed. The post-marketing commitments that are requested by the FDA are often hastily assembled by sponsors, who may not have a symmetric interest in safety and efficacy. Even so, once a drug is approved, CDER lacks the authority to force sponsors to complete agreed-upon post-marketing commitments or to require sponsors to initiate new studies. As a result, hundreds of agreed-upon studies remain "pending" in perpetuity. Since CDER lacks the resources to conduct its own studies, when a new drug is launched, the current regulatory system creates "an evidence-free zone."2
According to the 2003 report of the Office of Inspector General of the Department of Health and Human Services,3 a survey of CDER reviewers revealed that 66% lacked confidence in the FDA's safety monitoring of marketed prescription drugs, and 18% had felt pressure to approve a drug despite reservations about its quality, efficacy, or safety. In 2006, the Government Accountability Office found that the "FDA lacks clear and effective processes for making decisions about, and providing management oversight of, postmarket safety issues."4
On the basis of these reports and other evidence, the IOM committee identified a number of serious problems, including a lack of clear regulatory authority, chronic underfunding, organizational difficulties, and a scarcity of post-approval data. Contributing to an urgent need for cultural change in the FDA are a suboptimal work environment, a lack of consistency among CDER review divisions, polarization between the offices responsible for the pre-marketing review and post-marketing surveillance, CDER management's disregard and disrespect for scientific disagreement, and politicization and a lack of stability in the office of the FDA commissioner.
continued http://content.nejm.org/cgi/content/full...
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Pharmaceutical company and YOUR tax dollars.
A current article in the New Yorker goes into private funding for drug and disease research in area where the people so afflicted are such a small portion of the overall population that drug companies aren't interested in funding research or drug development because it wouldn't be economically lucrative.
The article discusses multiple myeloma (a lethal blood cancer).
Don't worry - your drugs for erectile dysfunction and acid reflux won't disappear and drug companies will continue to spend more in advertising these drugs than they will put into cancer research.
There will never ever ever be a mainstream cure from the drug companies, there will only be disease management. The drug companies have a legal obligation to there share holders, they can only have drug and treatments that manage the disease, there will never be a perminent mainstream cure, thats the sad truth. The FDA is set up so that if your not a multi billion dollar company you can not sell a drug to the public, you have to have a minimum of 700 million dollars to just be able to sell a drug, tested or not. The drug companies cannot have just any cure, it has to be something that people take for the rest of there lives as well as some type of extremely expensive treatment to go along with it. They will never research any other way to cure people, it has to be something that can be patented, it will never be something from nature, it will never be something that is inexpensive.
In China there are energy practitioners that use there heart as well as focused intent to dissolve tumors in a few minutes, because our hearts are liquid crystal ''DNA'' osculator pumps which produce different magnetic fields when combined with loving emotions. Or how Dr. Schulze got thrown in jail for curing people with terminal diseases with massive nutrition and detoxing, so the FDA threw him in jail, which is insane. The US government even states that most diseases are caused by nutritional deficiencies, yet they have laws that state only a drug can cure or a very expensive treatment thats owned by the drug companies can cure disease.
The AMA is mostly funded by the the drug companies which in turn controls what the doctors are taught. I don't hate doctors, we need them especially in crisis management situations, but they are only taught drugs and surgery which never solve true problem. The problem lyes when profits become more important then people, and if you say that isn't true then how come the man head of the FDA used to work for one of the largest drug companies. The scientist who are trying to find cures for disease mean well, but its the drug companies who eventually own the cures and turn them into manageable disease treatment. As long as the unholy alliance of the drug companies and the FDA are working hand in hand then there will never be world wide cures for anything, just just manageable disease treatments.