Amish farmer thrown in jail by FDA for not having "approved" medicine

Wescli Wardest wrote:

ren wrote: Surely the states have given that power away to the fed, just not through the constitution?

I can find no evidence that the authority of the state was given to anyone. But, I can find where the federal government took the authority away during the creation of administrative bodies such as the FDA, EPA and a myriad of other alphabet soup agencies. .
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Edit, addition made…

Not only that, the Due Process described and guarantied in the Constitution is directly violated by the actions and regulation enforcement of these agencies. That is one reason I posted the book and audio link in the previous post.

The document Br John posted of the outcome seemed to indicate the FDA's purview is to trade 'across' State borders specifically, which would seem to fit the scope of a Federal agency? But I know nuthin` about US law.

"The Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. ("FDCA"), existed to protect the health and safety of the American public by regulating the manufacture and distribution of all drugs shipped or received in interstate commerce. The Food and Drug Administration ("FDA'') was the federal agency charged with enforcing the FDCA. "

deciding on when laws are just or injust is tough

its hard to make general rules that will fairly to apply to every specific circumstance, forever

and once it becomes law, its not easy to change

maybe the FDA is an inherently tyrannical institution -i think the IRS is, for instanced- but on the surface of it, it does seem fair that there be laws about selling products meant for consumption and also laws about selling products with claims of medicinal properties

the use of laudanum as a cure-all in the 19th century comes to mind.
as an opioid its great for relieving the symptoms of all kinds of ailments, but its extremely addictive (very quickly) and the withdrawals process can be fatal

or cigarettes more recently- even after the tobacco companies knew that their products cause cancer they continued to lie about the risks and even deliberately marketed to children, knowing that the adults who smoked were mostly all going to die prematurely

so there is an argument to be made that we ought to have some organization that sets the standards for what can be sold and how, and what sort of information the distributor is required to put on the labels

the Amish people from what i understand are doing their very best to remain frozen in time as a culture, and i dont see enough information here to feel comfortable judging what this guys frame of reference was - maybe he was totally naive and maybe i would have done exactly what he did if i were in his shoes and had his level of understanding about "the English" (US) or maybe he was being deliberately obtuse and this whole things is really kind of his own fault

i only know that i dont know

but the laws exist for good reasons, and he did violate them, and he continued to violate them after he was told to stop, and now he has been found guilty of breaking them

the next step in the judicial process is the sentencing, which will happen some time in June, and until we learn what his punishment is going to be i dont know if we can fairly judge whether this is tyranny or not, or just how tyrannical it is

according to the articles, he could be facing several decades in federal prison, and that is something i would find reprehensible, as i believe that prison should only be for extremely violent and predatory people like j. dohmer and such

Wescli Wardest wrote:

ren wrote: Surely the states have given that power away to the fed, just not through the constitution?

I can find no evidence that the authority of the state was given to anyone. But, I can find where the federal government took the authority away during the creation of administrative bodies such as the FDA, EPA and a myriad of other alphabet soup agencies. .
[hr]
Edit, addition made…

Not only that, the Due Process described and guarantied in the Constitution is directly violated by the actions and regulation enforcement of these agencies. That is one reason I posted the book and audio link in the previous post.

What I mean is that the states accept it? For example, the state where the medicine was sold but not created could simply choose to do the FDA's job itself and tell the FDA to go home?

I have not yet heard why him not following a law (Which is unfair to begin with) warrants him to be taken away from his family and business and thrown behind BARS for something like this. Does the punishment really fit the crime? I don't think it does and it should be obvious by now that Big Pharma and the FDA is beyond corrupt and has been for years.

A few quick comments on the legality of all of this...

First, the FDA (or more specifically its predecessor, the Agricultural Division of the Patent Office) was created by a law passed by the U.S. Congress in response to the widely varying state laws that were inconsistent or sometimes nonexistent. The law addressed the creation of uniform standards for interstate commerce. The fact that the administration was created by the passage of a law by the U.S. Congress, it supersedes any claim by the states to maintain this authority. Because federal law passed pursuant to Constitutional authority overrules conflicting state laws, federal authorities still claim the authority to seize, arrest, and prosecute for possession and sales of unapproved substances, even in states where they are legal under state law. This is why recreational and medical use of marijuana can be legalized by states, but it still remains illegal under federal law and anyone using it can still be prosecuted.

Second, whether anyone personally believes the laws or the agency enforcing them are fair or corrupt doesn't matter in court. Laws are written, passed and signed by people we elect. They are put into place by representatives the majority voted into the positions to do so. They are enforced by judges we either elect or are appointed by people we elect. Just because an individual may disagree with a law, it never gives them legal standing to disobey it, and they will face the legal consequences when they do. This is what causes so many to be frightened when a President with the authority to pass executive orders without the approval of Congress starts banning travel and dismantling federal agencies. He is bypassing the representation we elected to Congress and we are left to rely on the judicial branch to keep the President in check. It isn't a perfect system, but that is why we as voters must participate and demand the changes we seek.

Third, on a more personal note, I willingly inject powerful chemotherapy drugs into my body every other week to combat cancer. I am choosing to poison myself, and I suffer some pretty nasty side effects as a result. Because of the FDA, the drug manufacturers and my doctor are required to inform me of these side effects and how likely they are to occur in my specific case. I currently take a chemo cocktail consisting of five drugs, and the resulting documentation is a notebook filled with over 80 pages of warnings, suggested dosages, potential interactions, possible allergies and descriptions of side effects. I'll gladly tolerate this egregious use of FDA authority over the alternative of taking some guy's word for it or guessing what I'm putting in my body and what might happen as a result.

EDIT: I should add that every chemo treatment I receive costs over $10,000, so it is pretty important to me that that these drugs have been studied and regulated appropriately.

Yabuturtle wrote: I have not yet heard why him not following a law (Which is unfair to begin with) warrants him to be taken away from his family and business and thrown behind BARS for something like this.

Because that's what a judge charged with deciding how to interpret the law as it applies to this case ruled.

Does the punishment really fit the crime?

A professional in the field seems to believe so.

I don't think it does and it should be obvious by now that Big Pharma and the FDA is beyond corrupt and has been for years.

What's your background in consumer law? I don't have any. I don't have an opinion about whether that punishment for that crime was appropriate, but I as a consumer would prefer it if the products offered to me, especially ones that are intended to aid my health, are thoroughly tested and reviewed and re-reviewed not only by experts in the field, but by a centralized body of experts that answer to the government elected by myself and my fellow citizens to represent our interests. And if it hasn't been subjected to any rigor like that, I do believe that I as a consumer have a right to know that, so much so that the manufacturer be obliged to disclose that information. It should in my opinion be considered a lie, and a dangerous lie at that, if it is omitted.
Now I should stress again that I am not in any significant way educated on matters of criminal law. But I do think that a family is more forgiving than a stranger. So a person who is violating the rights and interests of his clients who are by all means strangers, does so at the risk of their business, its reputation, and of course legal action against them. There is hardly any such risk in treating one's own family the same. It is of course not always the case that the closest ones, the most loved ones are at the highest risk of all, but to paint a separation from them as something more inhumane than a separation from society in general would perhaps be an overstatement of sorts.

The long and the short of it is simple.

Obey the law

Label your damn products

Be knowledgeable enough to protect yourself from persecution

If not...Then stop complaining when your dragged off in cuffs. Fair or not. Life isn't fair surely you know that by now.

I plan to sell salves sometime in the future. But until such a time I am doing what I can to learn the laws and what is required. Right now my biggest concern is how one is supposed to fit all the required info on a tiny tiny label

I have a better idea. How about the government minds it's own business and stop trying to regulate things such as medicine, food and so forth. You obey the law, within reason, not just blindly obey it. That's how tyranny gets started.

Anytime the government gets involved in things such as medicine, food, education ect. The cost goes up and the quality goes down. This has been an ongoing cycle. I should upload a whole list of actual drugs that are FDA approved and had to be recalled because of harmful side effects. But it seems like many like to put their head in the sand and assume the government will take everyone. They won't. Their only business now is taking care of those in the big club, not us people.

Well then. You just let me know how your war against the big pants goes Good luck!

Yabuturtle wrote: I have a better idea. How about the government minds it's own business and stop trying to regulate things such as medicine, food and so forth.

I disagree. The government has a duty of care before the people who elected it. If medicine or food stop being regulated, then anybody who ever gets sick for any reason can sue anyone and everyone they ever bought food or medicine from and the court will not have a standard provided by the government to decide who is in the right and who is in the wrong. Same the other way around: Anybody will be able to poison whom ever they please and so long as they have the means to afford a good enough team of lawyers, nothing can be done to stop them if the government is to stay out of it. What you are proposing is essentially anarchy, and while we can debate the legitimacy of government and state philosophy all night long, at the end of it we would be worse off without it.

Anytime the government gets involved in things such as medicine, food, education ect. The cost goes up and the quality goes down. This has been an ongoing cycle.

Have you actually read up on places where the government subsidizes healthcare or agriculture or education? I'm in one such country and we have some of the best medicine and education on the entire planet, because the government understands that healthy and educated citizens are what drives the economy and pretty much every secondary growth anybody could be interested in. Not only do we have some of the best healthcare and education as a standard, but those who come to be wealthy (because nobody ends up selling all of their livelihood and half their leg for a surgery that's necessary for them to remain functional and because high education can and does warrant well-paying jobs) can even afford private insurances and luxury treatments on top of that.

I should upload a whole list of actual drugs that are FDA approved and had to be recalled because of harmful side effects.

Please, do. And then list the ones that would have been recalled for harmful side effects if there was no regulation and no central testing body that would demand them being recalled.

But it seems like many like to put their head in the sand and assume the government will take everyone. They won't. Their only business now is taking care of those in the big club, not us people.

If you feel so, maybe try and convince your fellow voters to elect a new government, one that you have reason to believe will represent your interests instead of the big club's. I don't know how corrupt agencies like the FDA are currently, but the case discussed in this thread doesn't on the face of it seem to indicate that. You are seeing a rotten tooth, and your suggestion is not replacing it with a prosthetic, but just ripping out half the jaw with it. That's not how you'd solve the problem, that's how you'd make it worse.

I'm going to have to state the obvious here I think:

It is not in the interest of the pharma industry for you to be well, they only want you to be well enough to buy their stuff. The way they test new drugs (whether they are potentially harmful or not) is a clear indication this is the case.
The laws which regulate our lives are not fair or just. If they were we wouldn't bother with choosing and paying politicians to change them.

Don't go think that because something is state-financed that you're better off. I too live in a country where healthcare is provided free of charge by the state, and all i can say is i wish i could just pay for a doctor, it's that bad.

ren wrote: It is not in the interest of the pharma industry for you to be well, they only want you to be well enough to buy their stuff. The way they test new drugs ... is a clear indication this is the case.

Could you please present that way in full detail, and how it indicates what you says that indicates. I agree that a pharmaceutical company is not interested in your being well. That's why I think that there should be a single qualified buyer who is interested in that and can for that reason ensure that the products promise only as much as they are able to deliver, as well as push the manufacturer to develop products that are better for the end user. A company can afford losing one or fifty or a thousand customers who feel like it is fooling them, if it has millions more who won't notice. If those millions however are not individual customers but rather under the wing of a single buyer who understands as much about the subject as the manufacturer, there is only so much it can get away with before the buyer chooses to purchase the ware somewhere else.

Don't go think that because something is state-financed that you're better off. I too live in a country where healthcare is provided free of charge by the state, and all i can say is i wish i could just pay for a doctor, it's that bad.

Of course. The statement I was disputing went "Anytime the government gets involved in things such as medicine, food, education etc. the cost goes up and the quality goes down.", and there are enough examples of the contrary to say that what ever the rule is, if there be one, that one wouldn't be it. I'm also sorry to hear that you are not allowed to purchase medical treatment beyond the minimum your state demands of your physicians and that said minimum is as low as it is. Perhaps you and your fellow voters can petition your government to raise those standards or elect someone who would...

That's why I think that there should be a single qualified buyer who is interested in that and can for that reason ensure that the products promise only as much as they are able to deliver, as well as push the manufacturer to develop products that are better for the end user

Single qualified buyer, or 14,000+ assorted people making sure their job appears to be relevant and they can keep up payments on their mid size SUV and the next family holiday, a 3% pay rise next year would be nice too, and if I could get away with it I'd love to ask Janet over in filing over for a few drinks and some NSA fun.
I hope the boss lets me leave early on Friday so I can get to the ball game.

Does anyone know what happened with that Kentucky case?
Oh never mind, it's time for morning tea. I wish they'd get something better than stale hot cross buns.

"X would be better than Y, because conspiracy panic."
"No, X would be worse than Y (and here is why), Z would be better than either X or Y (and here is why)."
"But we don't have Z right now!"

What's your point?

I didn't come here to do algebra :side:

but if you're asking me what my point is - it's the same one I think I made a while back -

It's unlikely that the FDA is cackling mad and stroking white cats on a throne somewhere, but while on paper these agencies seem like a good idea and are often set up with good intentions, bureaucracies tend to steam roll common sense and a lot of people get chewed up in the plan to provide protection - and then everything starts costing money, and you've got to get that from somewhere, so you start making everything a crime (and catching those criminals) so you can prove to the government that if they don't buy your magic rock, the town will be overrun by tigers and so on and so forth.

I'm not weighing in on whether or not there is any corruption in the FDA from kickbacks by pharma companies, that is well beyond my scope.


I work with and around government agencies (not in the USA), so I speak in broad sweeping generalities as to how I've seen would-be good ideas turn into tumors.



My opinion is worth F-all as far as it goes - the USA is not my country and the FDA* has little to do with me, so as you've previously identified, if anyone believes there is an issue with the FDA's policies or processes, they need to leverage whatever authority they have, whether it be by vote, their local (member? senator? mayor?) twitter account, or .308 from a belltower to encourage the change they want.

Here's a list of drugs recalled by the FDA. Some stayed on the market longer than others. I know some will say "lolz this site is fakez" or something like that. Then it's best to look for it yourself then. Which makes me wonder, why do people ask for evidence when they end up rejecting it anyway because it doesn't fit with their perception of reality? The FDA is corrupt, apathetic and completely disregards the harmful side effects as long as they make money off of it. Of course that's also part of the plan too. You can't make money off of cured patients, can you?

http://consumerjusticegroup.com/fda-drug-recalls/recalltimeline/
http://prescriptiondrugs.procon.org/view.resource.php?resourceID=005528

Perfection is an illusion. Not that there is anything wrong with illusions, but they are on a different level then reality, they are instead an idea. The problem with the FDA is more then likely nothing more then a reduced version of the problem of people, the later being so large it cannot be elucidated while the former so refined it can be. That does not make the later worse then the former, only more tangible. If you've ever been on the inside of a government public service you'd probably have the opinion all the problems with it are not the structure or despotic elite, but rather just the incapability of people to be 'perfect' - and that this extends to wherever people are involved. There are really two ways to approach a problem, fix it or replace it, and so if you wanted to take an mechanical view to this topic I'd recommend reading 'The God of the Machine' by Isabel Paterson for a really interesting perspective of government history and function in terms of energy and mechanism.... though only half way through it I can tell it might fall to its own ideology in its remainder

Yabuturtle wrote: The FDA is corrupt, apathetic and completely disregards the harmful side effects as long as they make money off of it.

Absolutely correct.

Soooooo.....

What are you going to do about it?

Hmm, two dead links. Oh well. Moving on.

Yabuturtle wrote: Here's a list of drugs recalled by the FDA.
...
The FDA is corrupt, apathetic and completely disregards the harmful side effects as long as they make money off of it.

That doesn't make any sense. If they didn't care, why would they recall any drug ever? Public outcry can't be it, because there are plenty anti-vaxers and that doesn't seem to impress them much. There are probably as well plenty of drugs taken down few people actually even complained about. If it's about money, surely companies can themselves disengage production of drugs that aren't profitable and the FDA can't force them to keep producing. Likewise if the FDA is payed off, any amount is better than no amount, so again, why would they ever take down any drugs if they were not obligated by what ever source granted them their power, to use it in what ever way was specified by that entity?
Show me the list of harmful yet profitable drugs that would be off the market if there was no rules regarding either their effects or what can be claimed about their effects, I beg you.

Without trying to draw any analogies to the political environment in recent years, it is rather difficult to not sound defensive of something when the given accusations against it are so outlandish that one cannot help but differ... Of course the situation is not ideal, nobody is arguing that there is nothing wrong with the FDA. It's just that the proposed alternative of no regulation at all is pretty much the worst way of dealing with it. It is the equivalent of grenading your own squad in an effort to rob the hostiles of the glory.

Not sure why these links are coming up dead when I was using them not so long ago. I'll just post them

1. Accutane (Isotretinoin) on the market for
27
YEARS
Use: Acne
Manufacturer: Hoffman-La Roche 1982 to June 2009
Cause for recall:
increased risk of birth defects, miscarriages, and premature births when used by pregnant women; inflammatory bowel disease; suicidal tendencies

Over 7,000 lawsuits were filed against the manufacturer over the side effects including a $10.5 million verdict and two $9 million verdicts.

Baycol (Cerivastatin) on the market for
3
YEARS
Use: Cholesterol reduction
Manufacturer: Bayer A.G. 1998 to Aug. 2001
Cause for recall:
rhabdomyolysis (breakdown of muscle fibers that results in myoglobin being released into the bloodstream) which led to kidney failure; 52 deaths (31 in the US) worldwide; 385 nonfatal cases with most requiring hospitalization; 12 of the deaths were related to taking this drug in combination with gemfibrozil (Lopid)

Bextra (Valdecoxib) on the market for
3.3
YEARS
Use: NSAID (pain relief)
Manufacturer: G.D. Searle & Co. Nov. 20, 2001 to Apr. 7, 2005
Cause for recall:
serious cardiovascular adverse events (like death, MI, stroke); increased risk of serious skin reactions (like toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme); gastrointestinal bleeding

The FDA determined that Bextra showed no advantage over other NSAID pain relievers on the market.

4. Cylert (Pemoline) on the market for
30
YEARS
Use: Central nervous system stimulant to treat ADHD/ADD
Manufacturer: Abbott Laboratories 1975 to Oct. 2010
Cause for recall:
liver toxicity

The FDA added a box warning to Cylert in 1999, alerting doctors and patients to the potential of liver damage.

5. Darvon & Darvocet (Propoxyphene) on the market for
55
YEARS
Use: Opioid pain reliever
Manufacturer: Xanodyne 1955 to
Nov. 19, 2010
Cause for recall:
serious toxicity to the heart; between 1981 and 1999 there were over 2,110 deaths reported

The UK banned Darvon and Darvocet in 2005. The FDA was petitioned in 1978 and again in 2006 to ban the drug by the group Public Citizen.

. DBI (Phenformin) on the market for
19
YEARS
Use: antidiabetic
Manufacturer: Ciba-Geigy 1959 to Nov. 1978
Cause for recall:
lactic acidosis (low pH in body tissues and blood and a buildup of lactate) in patients with diabetes

7. DES (Diethylstibestrol) on the market for
31
YEARS
Use: synthetic estrogen to prevent miscarriage, premature labor, and other pregnancy complications
Manufacturer: Grant Chemical Co. 1940 to 1971
Cause for recall:
clear cell adenocarcinoma (cancer of the cervix and vagina), birth defects, and other developmental abnormalities in children born to women who took the drug while pregnant; increased risk of breast cancer, higher risk of death from breast cancer; risk of cancer in children of mothers taking the drug including raised risk of breast cancer after age 40; increased risk of fertility and pregnancy complications, early menopause, testicular abnormalities; potential risks for third generation children (the grandchildren of women who took the drug) but they are unclear as studies are just beginning

Studies in the 1950s showed the drug was not effective at preventing miscarriages, premature labor, or other pregnancy complications.

8. Duract (Bromfenac) on the market for
1
YEAR
Use: Pain killer
Manufacturer: Wyeth-Ayerst Laboratories July 1997 to
June 26, 1998
Cause for recall:
4 deaths; 8 patients requiring liver transplants; 12 patients with severe liver damage

Duract was labeled for maximum use of 10 days but patients often received/took more than 10 days worth of pills; all cases of death and liver damage involved patients taking pills for longer than 10 days.
9. Ergamisol (Levamisole) on the market for
11
YEARS
Use: Worm infestation; colon and breast cancers; rheumatoid arthritis
Manufacturer: Janssen Pharmaceutica May 8, 1989 to 2000
Cause for recall:
neutropenia (a type of low white blood cell count), agranulocytosis (a type of low white blood cell count), and thrombotic vasculopathy (blood clots in blood vessels) which results in retiform purpura (a purple discoloration of the skin that can sometimes require reconstructive surgery)

Levamisole is still used to treat animals with worm infestations in the US. It is also being found in street cocaine as an adulterant to increase euphoric qualities.

10. Hismanal (Astemizole) on the market for
11
YEARS
Use: Antipsychotic
Manufacturer: Janssen Pharmaceutica 1988 to
Aug. 13, 1999
Cause for recall:
slowed potassium channels in the heart that could cause torsade de pointes (TdP; a heart condition marked by a rotation of the heart's electrical axis) or long QT syndrome (LQTS; prolonged QT intervals)

11. Lotronex (Alosetron) on the market for
0.8
YEAR
Use: Irritable bowel syndrome (IBS) in women
Manufacturer: Prometheus Laboratories, Inc. Feb. 9, 2000 to Nov. 28, 2000
Cause for recall:
49 cases of ischemic colitis (inflammation and injury of the large intestine); 21 cases of severe constipation (10 requiring surgery); 5 deaths; mesenteric ischemia (inflammation and injury of the small intestine)

Lotronex was reintroduced to the US market in 2002 with restricted indication.

12. Meridia (Sibutramine) on the market for
13
YEARS
Use: Appetite Suppressant
Manufacturer: Knoll Pharmaceuticals Nov. 1997 to
Oct. 2010
Cause for recall:
increased cardiovascular and stroke risk

FDA reviewer Dr. David Graham listed Meridia with Crestor, Accutane, Bextra, and Serevent as drugs whose sales should be limited or stopped because of their danger to consumers in Sep. 30, 2004 testimony before a Senate committee, calling the drugs "another Vioxx."

13. Merital & Alival (Nomifensine) on the market for
3
YEARS
Use: Antidepressant
Manufacturer: Hoechst AG (now Sanofi-Aventis) 1982 to 1985
Cause for recall:
haemolytic anemia; some deaths due to immunohemolytic anemia

14. Micturin (Terodiline) on the market for
2
YEARS
Use: Bladder incontinence
Manufacturer: Forest Labs Aug. 1989 to
Sep. 13, 1991
Cause for recall:
QT prolongation and potential for cardiotoxicity

15. Mylotarg (Gemtuzumab Ozogamicin) on the market for
10
YEARS
Use: Acute myeloid leukemia (AML, a bone marrow cancer)
Manufacturer: Wyeth May 2000 to
June 21, 2010
Cause for recall:
increased risk of death and veno-occlusive disease (obstruction of veins)


16. Omniflox (Temafloxacin) on the market for
0.3
YEAR
Use: Antibiotic for pneumonia, bronchitis, and other respiratory tract infections; prostatitis and other genitourinary tract infections; skin ailments.
Manufacturer: Abbot Laboratories Jan. 31, 1992 to June 5, 1992
Cause for recall:
3 deaths; severe low blood sugar; hemolytic anemia and other blood cell abnormalities; kidney disfunction (half of the cases required renal dialysis); allergic reactions including some causing life-threatening respiratory distress




17. Palladone (Hydromorphone hydrochloride, extended-release) on the market for
0.5
YEAR
Use: Narcotic painkiller
Manufacturer: Purdue Pharma Jan. 2005 to
July 13, 2005
Cause for recall:
high levels of palladone could slow or stop breathing, or cause coma or death; combining the drug with alcohol use could lead to rapid release of hydromorphone, in turn leading to potentially fatally high levels of drugs in the system




18. Permax (Pergolide) on the market for
19
YEARS
Use: Parkinson's disease
Manufacturer: Valeant 1988 to Mar. 29, 2007
Cause for recall:
valve regurgitation (a condition that causes the valves to not close tightly, which allows blood to flow backward over the valve) in the mitral, tricuspid, and aortic heart valves, which can result in shortness of breath, fatigue, and heart palpitations

Permax is still available in the U.S. for veterinary use, specifically for pituitary pars intermedia hyperplasia or equine Cushing's Syndrome (ECS) in horses.




19. Pondimin (Fenfluramine) on the market for
24
YEARS
Use: Appetite suppressant
Manufacturer: Wyeth-Ayerst 1973 to
Sep. 15, 1997
Cause for recall:
30% of patients prescribed the drug had abnormal echocardiograms; 33 cases of rare valvular disease in women; 66 additional reports of heart valve disease

Pondimin is better known as "Fen-Phen" when prescribed with Phentermine.




20. Posicor (Mibefradil) on the market for
1
YEAR
Use: Calcium channel blocker (used to treat hypertension)
Manufacturer: Roche Laboratories June 1997 to
June 1998
Cause for recall:
fatal interactions with at least 25 other drugs (ex: common antibiotics, antihistamines, and cancer drugs) including astemizole, cisapride, terfenadine, lovastatin, and simvastatin

Posicor was found by the FDA to offer no significant benefit over other anti-hypertensive or antianginal drugs, which made the risks of drug interactions "unreasonable." Patients immediately switching from Posicor to another calcium channel blocker were at increased risk of going into shock within 12 hours of the drug switch.




21. Propulsid (Cisapride) on the market for
7
YEARS
Use: Severe nighttime heartburn associated with gastroesophageal reflux disease (GERD)
Manufacturer: Janssen Pharmaceutica 1993 to July 14, 2000
Cause for recall:
more than 270 cases of serious cardiac arrythmias (including ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation) reported between July 1993 and May 1999, with 70 being deaths.

Propulsid is also banned in India (2011) and available for limited use in Europe. It is still available for use in animals in the US and
Canada.




22. PTZ & Metrazol (Pentylenetetrazol) on the market for
48
YEARS
Use: Convulsive therapy for schizophrenia and other psychiatric conditions
Manufacturer: not known 1934 to 1982
Cause for recall:
uncontrollable seizures; pulled muscles; fractured bones; spine fractures in as many as 42% of patients




23. Quaalude [Marketed as: Optimal, Sopor, Parest, Somnafac, and Bi-Phetamine T] (Methaqualone) on the market for
23
YEARS
Use: Sedative and hypnotic
Manufacturer: William H. Rorer Inc. & Lemmon Company 1962 to 1985
Cause for recall:
mania; seizures; vomiting; convulsions; death

Methaqualone was originally tested in India as a malaria treatment (it was ineffective). The drug is now a schedule 1 drug in the United States (like heroin, marijuana, and LSD).


24. Raplon (Rapacuronium) on the market for
2
YEARS
Use: Non-polarizing neuromuscular blocker (used in anesthesia
Manufacturer: Organon Inc. 1999 to
Mar. 27, 2001
Cause for recall:
bronchospasms and unexplained deaths




25. Raptiva (Efalizumab) on the market for
6
YEARS
Use: Psoriasis
Manufacturer: Genentech 2003 to
Apr. 8, 2009
(completely withdrawn by
June 8, 2009)
Cause for recall:
progressive multifocal leukoencephalopathy (PML; a rare and usually fatal disease that causes inflammation or progressive damage of the white matter in multiple locations of the brain)




26. Raxar (Grepafloxacin) on the market for
2
YEARS
Use: Antibiotic for bacterial infections
Manufacturer: Glaxo Wellcome 1997 to
Nov. 1, 1999
Cause for recall:
cardiac repolarization; QT interval prolongation; ventricular arrhythmia (torsade de pointes)




27. Redux (Dexfenfluramine) on the market for
1
YEAR
Use: Appetite suppressant
Manufacturer: Wyeth-Ayerst 1996 to Sep. 15, 1997
Cause for recall:
30% of patients prescribed the drug had abnormal echocardiograms; 33 cases of rare valvular disease in women; 66 additional reports of heart valve disease

Redux is better known as "Fen-Phen" when prescribed with Phentermine.




28. Rezulin (Troglitazone) on the market for
3.25
YEARS
Use: Antidiabetic and anti-inflammatory
Manufacturer: Parke-Davis/Warner Lambert (now Pfizer) Jan. 29, 1997 to Mar. 21, 2000
Cause for recall:
at least 90 liver failures; at least 63 deaths

About 35.000 personal injury claims were filed against the manufacturer (Pfizer).




29. Selacryn (Tienilic acid) on the market for
3
YEARS
Use: blood pressure
Manufacturer: SmithKline May 2, 1979 to 1982
Cause for recall:
hepatitis; 36 deaths; at least 500 cases of severe liver and kidney damage

Anphar Labs (which developed the drug in France and sold rights to sell in US to SmithKline) sent a report to SmithKline in Apr. 1979 (translated in May 1979 to English from French) stating Selacryn damaged livers. On Dec. 13, 1984, SmithKline Beckman plead guilty to "14 counts of failing to file reports with the drug agency of adverse reactions to Selacryn and 20 counts of falsely labeling the drug with a statement that there was no known cause-and-effect relationship between Selacryn and liver damage"




30. Seldane (Terfenadine) on the market for
13
YEARS
Use: Antihistamine
Manufacturer: Hoechst Marion Roussel (now Sanofi-Aventis) 1985 to
Feb. 1, 1998
Cause for recall:
life-threatening heart problems when taken in combination with other drugs (specifically erthromycin (an antibiotic) and ketoconazole (an antifungal)

Seldane was not considered an imminent threat. The FDA pulled Seldane from the market because Allegra and Allegra D were produced by the same company and were deemed safer by the FDA.




31. Trasylol (Aprotinin) on the market for
15 (48)
YEARS
Use: antifibrinolytic to reduce blood loss during surgery
Manufacturer: Bayer 1993 (but used since the 1960s) to Nov. 5, 2007 (marketing suspension request to phase it out of the market);
May 14, 2008 (manufacturer announced complete removal from market)
Cause for recall:
increased chance of death, serious kidney damage, congestive heart failure, and strokes

On Feb. 8, 2006, the FDA issued a public heath advisory to surgeons who perform heart bypasses, alerting them of possible fatal side effects.




32. Vioxx (Rofecoxib) on the market for
5.3
YEARS
Use: NSAID (pain relief)
Manufacturer: Merck May 20, 1999 to Sep. 30, 2004
Cause for recall:
increased risk of heart attack and stroke; linked to about 27,785 heart attacks or sudden cardiac deaths between May 20, 1999 and 2003

Ads for Vioxx features Olympic gold medalists Dorothy Hamill and Bruce Jenner. Vioxx was prescribed to more than 20 million people.


33. Xigris (Drotrecogin alfa (activated)) on the market for
10
YEARS
Use: Severe sepsis and septic shock
Manufacturer: Eli Lilly & Company Nov. 2001 to
Oct. 25, 2011
Cause for recall:
no survival benefit




34. Zelmid (Zimelidine) on the market for
0
YEARS
Use: Anti-depressant
Manufacturer: Astra AB (now AstraZeneca) 1982 to 1982 (withdrawn by the FDA before being released in the US market)
Cause for recall:
Guillain–Barré syndrome; higher risk of suicide




35. Zelnorm (Tegaserod maleate) on the market for
4.6
YEARS
Use: irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55
Manufacturer: Novartis July 24, 2002 to Mar. 30, 2007
Cause for recall:
higher chance of heart attack, stroke, and unstable angina (heart/chest pain)

The FDA permitted restricted use of Zelnorm on an emergency basis (with prior case-by-case authorization from the FDA) on July 27, 2007.




And THESE are the drugs that were recalled. There's still drugs out there on the market that are dangerous, too. I know some might wonder, if they did not care about people, why recall? Well it's obvious that when they are caught, they need to recall or they end up looking bad, but by then, it's too late. The people got killed or sick, and they still made their money for the most part. Even if they get sued, it doesn't even take a fraction of their profits.

It's easier to digest the thought that your government would never betray you. Because no government in history has ever betrayed it's own people right? Just as the soviets, Nazis, north Koreans ect.