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16.04.2015

How are new drugs tested, tinnitus ear plugs concert - Test Out

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Emma Ketteringham, an attorney who has represented such women in both Alabama and New York City, took it a step further in the same piece: “The idea that the state needs to threaten and punish women so that they do the right thing during pregnancy is appalling. How the National Committee on Volunteers WorkedThe United States has a rich history of volunteerism, beginning in the 1700s with Benjamin Franklin's firefighting squadron. More than 205,000 new drugs are marketed worldwide every year, most after undergoing the most archaic and unreliable testing methods still in use: animal studies.
Human reactions to drugs cannot be predicted by tests on animals because different species (and even individuals within the same species) react differently to drugs. Experimenters involved in a 1993 test of a hepatitis drug that led to five deaths were exonerated by a panel from the Institute of Medicine, which directly conflicts with the findings of the FDA. Experimenters using animals are less apt to notice symptoms like emotional changes, dizziness, nausea, and other important but less obvious conditions.
The British journal Nature reports that 520 of 800 chemicals (65 percent) tested on rats and mice caused cancer in the animals but not in humans. As long as the pharmaceutical industry cranks out thousands of new drugs every year, the public must push for the implementation of reliable, non-animal testing methods to ensure the safety of these drugs. Despite the inaccuracies of animal tests, and the many cases of dangerous drugs having to be withdrawn from the market after passing animal tests with flying colors, the FDA continues to require animal studies before a drug can be marketed in the United States. They point out that unreliable animal tests not only allow dangerous drugs to be marketed to the public, but may also prevent potentially useful ones from being made available.


The same report illustrated different results between rats and mice used to test the same substance. If the research is fruitful and a new method is shown to have treatment potential, it is first tested on live animals (with regulatory oversight) such as guinea pigs or rats to see if it's toxic or if unexpected side effects develop. According to the General Accounting Office, more than half of the prescription drugs approved by the Food and Drug Administration (FDA) between 1976 and 1985 caused serious side effects that later caused the drugs to be either relabeled or removed from the market. Penicillin would not be in use today if it had been tested on guinea pigs--common laboratory subjects--because penicillin kills guinea pigs.
These animals may be bred or designed to have the condition that is being tested, such as low testosterone, high blood pressure or cancer. Drugs approved for children were twice as likely to have serious post-approval risks as other medications. According to the FDA, 84% of the new drugs produced by the 25 biggest drug companies had little or no potential for improving patient care. Testing positive for marijuana can unleash a round of child neglect and protection proceedings, though attorneys have presented in court medical testimony that marijuana use, while not exactly beneficial to the fetus, doesn’t actually harm it. Animals are also given the new treatment prior to mating to see if the treatment adversely affects reproduction or causes birth defects. In this case, the animal tests did reflect human reactions, and now hundreds of children have been born with birth defects caused by Accutane.


If you must take a drug, ask your doctor what clinical studies, not animal tests, reveal about the drug. Many arthritis drugs that passed animal tests, including Feldene, and Flosint, have been pulled from the market because they caused severe reactions or even death in human beings.
According to an April story by Ada Calhoun in the New York Times magazine, about 60 women have been prosecuted under the law, some for using drugs that are more serious and addictive than marijuana. Once approved, the new drug then undergoes what is supposed to be (but isn't always) a rigorous testing regimen consisting of several phases:Phase I tests the new treatment in small quantities on a small number of people (fewer than 100) to determine if it's safe, if it has side effects, and to learn how it's metabolized by the body. Phase I involves very close medical supervision.Phase II usually involves several hundred volunteers to determine if the drug (now deemed safe) is effective as a treatment.
You are looking at people who think that these are horrible women who are rationally, willfully hurting their kids, but it’s more complicated than that. Researchers will increase dosage to find the minimum and maximum amounts that can be safely delivered while still being effective.Phase III trials are conducted to see if the drug is more effective than similar treatments already available. Thousands of volunteers are tested, and sometimes drugs are pulled off the market because serious drawbacks are discovered even in this late stage of testing.



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