Steve Gillman questioned :


We want to reckon that the research done by the pharmaceutical companies is honest, but more than one news tale has shown otherwise. If we had the political will, or if the FDA was less political, drug trials could be made more honest very nearly immediately with one simple procedure. Unfortunately, that change has been fought by the drug companies. Let’s see why.

The English newspaper, The Guardian, recently reported on several systematic reviews of drug research. They visibly showed that pharmaceutical industry studies and clinical trials crash positive results far more often than persons funded independently (funded by persons not promotion the drugs tested). Is it just a coincidence that drug companies get more of the results that they’re looking for? No.

The drug companies probably very nearly never directly tamper with clinical drug trials, nor are they likely to change the reported results afterwards. Dishonesty or criminal behavior like that is probably very rare in drug research, because it isn’t needed. More subtle ways are unfilled .
How To Manipulate Drug Research Results

The most run of the mill way to manipulate the results of drug research, is the simplest of all. If you want to show that a new pharmaceutical works, just get rid of the trials that show it doesn’t, and keep the ones that show some effect. Investigations have demonstrated that this is run of the mill , that negative data is often hidden or discarded.

Infer a new drug is given to twelve groups of broadcast who share a given disease. It appears to help the broadcast in four of the groups, but the subjects in the other eight groups have no improvement or perhaps even get sicker or have serious side effects. Differing results from one trial to the next is run of the mill , since broadcast get better or worse for many reasons. This is why many trials are necessary to be statistically significant.

What if in this case, the company chose that only the four trials with positive results are vital , and they quietly get rid of the data from the other eight. Suddenly a drug with no real benefit appears to have helped in every clinical trial – at least every one we’ll know about. It is very terrible science, of course, but one of the most run of the mill ways pharmaceutical companies manipulate drug research results.

How do we stop this? Researchers have been recommending an inexpensive solution to this conundrum for decades: make the companies register all trials, so none can be “lost.” To use the results of any drug research to get a new pharmaceutical approved, a company would have to register the trial before it starts , in a compulsory international trials registry. It would add very small to their costs.

Naturally the drug companies are against this simple thought , and certainly have their arguments to present. The most likely real reason they are fighting it is that it doesn’t allow them as much control over the “truth” or the results of drug research. And with our own FDA staffed by their friends and former coworkers, we can  expect this dishonesty to go on.



EMMANUEL

KathyTippleman questioned :


The real subject of pharmaceutical research and development is very broad and covers many areas of products development and analysis. As a direct result of the broad scope of the research and development work that is being done in the pharmaceutical industry, there is wide variety of unique development programs as a whole to deal with the huge number of intrinsic issues related to the work.

More Effective Drug Therapies
One result of the degree that pharmaceutical research is spread out and diversified is that a proportionally large number of pharmaceutical companies engaged in it are presently operating online as well as off line to expedite the completion of their ongoing projects. Bold new, innovative development concepts and newer more progressive project management concepts and techniques have all combined to lead towards the development of newer more effective products and therapeutic treatments.

Two Seperate Catagories

Commonly, pharmaceutical research and development is bisected into two discreet categories with discovery being one and development being the other. As a general rule, pharmaceutical discovery tends to be focused in the area of biological and chemical considerations. Development, on the other hand, encompasses a large number of aspects, including but not excluded to drug and therapy development, safety and security issues as well as clinical research and other medical aspects.

Multitudes of Legal Considerations

Still one more area of pharmaceutical research and development deals with the multitudes of legal issues that take in the pharmaceutical industry as a whole, such a patents and transfer technicalities. The testing process alone, to insure viability and safety after the real development process on a drug has been completed can take up to ten years. In the end though , all of the complexities of pharmaceutical research and development converge as a whole for the run of the mill goal of producing effective and affordable drug therapies.



SANTOS

Nathan Wei questioned :


Research trials are conducted for all pharmaceutical drugs for arthritis that eventually reach the market.

A clinical research trial may be the only way you can get early access to a breakthrough arthritis treatment; though , there are pluses and minuses so it’s vital to know the questions that need to be questioned and answered.

It should be emphasized that a clinical trial is just another component of standard arthritis treatment. It should be considered as an option for patients receiving conventional care.

Clinical trials are research studies that evaluate a new drug or treatment in three separate phases, prior to FDA approval. In a Phase I trial, the safety and the dosing level of a new drug are tested in a small group of patients. The trial examines the pharmacologic action of the drug in humans and its side effects at different dosage levels.

Often, the earliest subjects in a phase I trial are normal volunteers.

In a Phase II trial, the drug is further tested for safety and for efficacy in a larger group of broadcast who have the disease under study.

Once efficacy has been established, the drug is tested in a Phase III trial among several hundred to thousands of patients to further explore its safety and efficacy and whether or not it is better than conventional treatment for arthritis.
Phase III trials attract the most attention among arthritis patients; though , not everyone can be in a trial, nor are they guaranteed to get the drug being tested. To be in the trial, patients must first meet entrance criteria, which are very specific and which exclude many patients. If they are accepted, patients may be randomly assigned to different treatment groups, depending on the phase of the trial.

In a Phase III trial, the “test” group receives the new drug, while the “control” group receives either the standard treatment for that specific type of arthritis or a placebo (an inactive pill, liquid or powder). In some trials, called a “release -blind” study, researchers are aware of who is taking what drug, while in others, called “dual -blind,” neither the participants nor the research team knows what the participants are receiving.

Sometimes trials are stopped early, for a variety of reasons. One possibility is that one treatment is found to be vastly superior to the other, while another is exactly the opposite — a treatment is found to be perilous . When trials end early because of positive results, the patients receiving the beneficial treatment will continue to get it, and also, the rest of the patients in the trial are offered the drug as well.

Obviously, if the results are negative, the drug is immediately stopped in all patients.

Make sure you see an expert rheumatologist. It may be worth traveling some distance to find the best expert for your arthritis condition.

Educate yourself. Read everything you can about the center and the trial.

Questions to question :

• How long has the center and the rheumatologist been conducting research?

• Have there been other studies that evaluated this drug, and if so, what were the results?

• How do the risks, side effects and benefits compare with my current treatment?

• What are my odds for receiving a placebo if I participate in the study?

• Who is the research team that will take care of me during the study?

• Will involvement require an extra time or journey commitment on my part… and will I be reimbursed for expenses?

• How might the study affect my daily life?

• How will I be informed about new risks that may be identified during the trial?

• If the treatment is working for me, can I continue getting it even after the study ends?

• What are my costs associated with the trial? Will my insurance take in the costs? If not, what will it cost me?

• Are there other patients already taking part in the study whom I could speak to?

• Will I be able to find out about the results of the study at the end?

Research clinical trials are an option for getting first ***** at new drugs, saving money, and also for helping to make a contribution to medical research and to the future health of others with arthritis.



CARY