How many people need must die before the FDA recalls the drug?

Question

In regards to RU-486, 5 women have died and there had been evidence of the drugs adverse side effects, even before it was approved. How many people must die before a drug is finally approved. This is for my pharmacology class.

This is not whether I agree or disagree on the use of the drug Ru-486, but I just need to get some statistics for my class. Does the FDA have a certain # of people that must die before a drug is recalled, such as RU-486?

Answer 1

RU-486 isn't nearly as lethal as aspartame, and that's in millions of bottles of softdrinks and other comestibles.

To answer your question, though, every prescription drug has adverse side effects, including lethality for some segment of the population; allergies account for most of these types of deaths that aren't penalized by the FDA.

RU-486 has low mortality rate, is used for a small segment of the population, and is well documented through years of dispensing in Europe. It's not a great risk.

Watch that aspartame, though. And Splenda's no better!

Answer 2

only five and your complaining.....that isn't much toots, this drug has been out there a long time. Its helped a lot of people whether or not you or I agree with it. It is a million times safer than the alternative and though I am not pro choice......I thank God and accept his punishment for utilizing it.

You need to reword the last sentence as you are asking how many women must die before it is approved.....I take it you mean recalled.

A hell of a lot more than five people have died from taking aspirin and then bleeding out when they are involved in a car accident.....should we take it off the market too?

Answer 3

Sad to say..........the power of the pharmaceuticals is almost 'limitless' ............. the world is lubricated by money ......... n profits drives the big corporations that manufacture so-call wonder drugs.

There is no public statistics on the number of women....... many are young girls....... who had lost their lvies to RU-486........... and you can bet the pharmaceuticals are not going to give you any true figures....... they always hide behind legal languages ........... e.g. ".......to the best of our knowledge we know of no negative effect......... in reference to our products. Our exhaustive reserch shows no....blah...blah...blah."

The FDA is a toothless 'tiger'...........and the offcials all turn into pussycats when they are being entertained by the pharmceuticals............. have you met doctors & FDA officials with the pharmaceuticals' representative................ just close your eyes to the warm smies you see on their faces.........n I bet in your mind's eyes you could see........pussycats & pussydogs wagging their tails!

Answer to your question: the answer......my friend......is blowing in the wind!...........the answer is blowing in the wind!

Answer 4

no matter what the drug is someone will die from it, asprin can kill if you are sensative to it, its a matter of numbers. sorry bout that but more women are helped by it than die, by the thousands.

Answer 5

1993: USA: Nearly 40 different natural healing clinics, health food stores, and vitamin manufacturers were raided in May and September, in armed commando-style assaults by combined agents of the FDA, DEA, IRS, US Customs and US Postal services. Details on these more recent raids are difficult to come by, but it is reported that, besides seizing various stocks of vitamins, herbs and other nutritional supplements and compounds (such as shark cartilage), IRS officials seized both personal and company bank accounts, along with automobiles, computers, office equipment, and other valuables. Mailing lists of customers and patients were of particular interest in the seizures. The homes of the company owners and employees were also raided, without search warrants. SWAT teams, armed with machine guns and flak jackets, participated in some of the raids. The Post Office, in turn, acted to illegally block the mail of some of the companies, effectively shutting them off from communication with the public and leaving them without funds, mailing lists, or other resources necessary to mount a proper legal defense.

As before, no charges were filed.Some shocking examples of Gestapo tactics occurred. At the home of one employee, dark-dressed men with guns demanded entry, but the scared individual refused to let them in; instead, she went to the bedroom to dial 911 for the local police. The door was smashed down and she was shoved to the floor with a gun put to her head.

In another case, a breast-feeding mother employed at a raided firm was roughed-up and handcuffed for 11 hours while FDA agents ransacked her home. These latter raids included the clinic and offices of Dr. Kurt Donsbach, author of many self-help nutrition-oriented books widely sold in health food stores. Donsbach's home was also reportedly raided, and his personal bank accounts seized. Also raided were the USA distributors of German-made Neiper Products, formulated by the internationally-known and respected Dr. Hans Neiper, who operates a successful clinic in Germany, and sponsors the popular health-science magazine Raum & Zeit. Many ordinary citizens were manhandled and threatened with death by gun-pointing government agents during these raids, all for the "crime" of manufacturing, distributing, selling or prescribing vitamins, nutritional supplements, and related natural health products or methods.(23)

The above are only representative examples from a very long list of similar FDA abuses of power in recent years. The FDA clearly has become the attack-dog tool of the AMA and pharmacy industry, and many FDA field agents are on record as stating that the agency is out to "destroy the health food and nutritional supplements industries". And that is precisely what they are trying to do. FDA Director Kessler wants to control not only the marketing of products, but also what is said in speech or print about health matters. He has vowed to "crack down" even on scientific meetings and conferences which present findings "unacceptable" to FDA policies, and this is no idle threat. Kessler and the FDA are the closest thing to a domestic Gestapo-type police force in the USA, and their power is growing; new alliances are being cemented between the FDA, IRS, DEA, FTC, Customs and Postal Services, HHS and other government agencies, to "combat the growing menace of health fraud".

The FDA alliance has destroyed the lives and work of numerous medical pioneers, as outlined above, usually without any charges being filed. They simply arrive at the offending clinic and home of the pioneer, break down the doors, shove guns into the faces of everyone present, seize and impound office and laboratory equipment, mailing lists, computers, files, bank accounts, etc., carting everything off to a warehouse where it is dumped. Even personal funds in a bank account are "impounded" (stolen!) by these government thugs, whom we may assume are, like DEA agents raiding a crack house, using drug-seizure laws to keep a percentage of whatever they steal! Amazingly, none of the major political parties have displayed alarm or interest in these FDA assaults. It has all been done with the full knowledge and approval of top politicians (Reagan, Bush, Clinton, Gore) and Justice Department officials (Janet Reno). Virtually all of these politicians have consistently been sent letters of protest by the lawyers, friends, patients and co-workers of the various clinicians or small businesses who have been raided -- to my knowledge, nobody who has been raided by the FDA has ever received a friendly note or a helpful response from any of our political Royal Family. These power elites either agree with the FDA, don't care about natural health matters, or are completely isolated from what is going on in the real world by layers of bureaucracy and "helpers", who censor the the pleas for help from their mail and telephone calls.

The FDA raids demonstrate a serious erosion in the principles of government by law, due process, liberty and justice. For health matters, at least, we now have government by iron-fisted bureaucratic decree, with only the facade and illusion of law. Originally, the FDA was formed under the mandate of the Pure Food and Drug Act which simply required that products be accurately labeled as to what their contents are and to actually contain those ingredients, which is a necessary regulation in order for consumers to make informed decisions. However, this simple mandate has grown into a bureaucratic monster which has decreed itself the sole judge, jury, and prosecutor (with its own hit squads) on matters of medical efficacy. Since Reich's time, and through the 1960s, 1970s and 1980s, the FDA has consumed millions of taxpayer dollars to wage its war against natural approaches to health care. The result is that our health care system is one big gigantic expensive mess, rife with official fraud, and a holocaust of victims due to the toxic and deadly side effects from ineffective "approved" drugs and horrific surgical mutilations. Nature, science, and compassion have been thrown out of the house of modern medicine, and the doors and windows have been barred shut, with armed guards posted outside.