29.8 Million dollar settlement?!
- 08-19-2005, 04:52 PM
29.8 Million dollar settlement?!
Anyone else find this fair? I mean they should know there is a risk involved with taking these drugs every day. I think 30 million is WAY overdone! Everyone is greedy these days. And they always say things like "it isn't about the money, I just wanted them to pay for their mistakes." Alright in that case lets see if they give all of that to charity. Won't happen.PharmD
- 08-19-2005, 05:32 PM
After reading more into the case, this IS a situation where Merck failed to design adequate clinical trials. Their trials were designed such that this severe adverse event was EXTREMELY unlikely to show up. Especially since they were not monitoring cardiac data sufficiently.
They also did not adequately report adverse event data to the FDA. That is a SERIOUS SERIOUS SERIOUS offense.
While I don't think there was malfeasance, drug companies DO have a responsibility to be as thorough as possible in their clinical trial design and even moreso in their adverse event reporting.
Any company which violates that deserves whatever settlements are judged against them.
...and this is coming from someone who works for a big pharmaceutical company.
- 08-19-2005, 05:41 PM
When you consider that at its peak mercks worth was ~50billion (not nearly that now) and there are 4200 cases left to go. The judgement is completely rediculous. These people won't see that money.
Its too bad that it is merck as they are the ones who lead the vaccine field. No one wants to make vaccines because they are so risky and not terribly profitable.
08-19-2005, 06:21 PM
Originally Posted by velikimajmun
Yeah this is exactly right. I mean you cant get everyone 30 million dollars. It is a tragedy yes, but I mean cmon now.
08-19-2005, 06:52 PM
Does anyone else find it ironic that during a lawsuit about pharmaceuticals that she was using using prescription antidepressants to cope...WTF???I guess she did not learn that with any supplement, whether it be OTC or Rx, there is a risk of side effects
08-20-2005, 01:04 AM
She may not have deserved it, but MERK DID!
Pharmaceuticals are the most profitible companies in the world. They have influence in congress, the FDA, the FTC, the media, medical schools... the list goes on. Think about it. They haven't cured a single disease since Polio! And it was an independant doctor who came up with the vaccine, not some corporate lackey scientist working for a pharm company
If it were up to me, I'd take the CEO's of every pharmaceutical company and give them a different, incurable (or low-cure rate) disease. I guarantee in a year there will be a cure for every one of them. I could get into all the corruption, but this would turn into an article, not a post. Do you think the board of executives at MERK care about the 30 mil? Hell no. They sold their personal stock right before the Viox scandal was made public. How, because they control the media. Likewise, the major media players who own stock in MERK dumped the stock as well.
As far as inadequate clinical testing, MERK probably did it, just buried the results, greased the right FDA palms, and got it approved despite the risks.
These Pharmaceutical bastards make Pablo Escobar look like Mother Theresa. They are crack-slinging, corner dwelling drug dealers, taking advantages of people; only they wear $3000 suites and drive $50,000 cars and live in any one of their five mansions.
They deserve everything they get... and then some.
08-20-2005, 03:54 AM
Harsh statement, but I have to agree. The prescription drug industry is enourmous - everywhere you look another add with a bunch of happy,smiling people followed by a auctioneer-like list of side effects that makes meth look like asprin.These Pharmaceutical bastards make Pablo Escobar look like Mother Theresa. They are crack-slinging, corner dwelling drug dealers, taking advantages of people; only they wear $3000 suites and drive $50,000 cars and live in any one of their five mansions.
Yeah, people are stupid enough to believe they have to take all these drugs - but when their own doctor is recommending it they follow blindly. The same physicians getting kickbacks from the pharmaceutical industry.
Throw a guy with a few 'scheduled' plants or chemicals in jail longer than a rapist, but a company that created and marketed a drug that *killed people* gets a $30 million fine and thats harsh? And that is because the general public should know better than to pop pills everyday?
The fact is a lot of people made an assload of money selling a drug that resulted in people dying before their time should have been up. If that were my wife/brother/friend/etc. Id want a hell of a lot more than $30 million, I'd want their blood.
08-20-2005, 09:44 AM
Wrong.Originally Posted by Viator
Gleevac is a cure for Chronic Myoloid Leukemia. It was approved a few years ago and has already saved tens of thousands if not over a hundred thousand lives.
08-20-2005, 12:37 PM
Yeah, I guess the jury could overlook the fact that the Dude was old, had athereosclerosis, etc. Drug companies are higly regulated by FDA and still get sued, how about suing the FDA. I guess suing the drug companies will make drugs cheaper, right? If any of the supplements we all like to take were subjected to the same scrutiny that Vioxx was, how many of them would make the cut? Would aspirin? What drug is safe? Funny thing is, the FDA upon looking at the whole thing said Vioxx could come back on the market, reality is that the risk isn't that much. When actual studies powered for the adverse event were done, it didn't show statistical significance until 18 months. The head of Merck research who knew as much about the risk as anybody was a regular vioxx user for years, I guess Dr. Skolnick must have been stupider than those 10 jurors down in Texas. But hey, drug companies are big, so they must be bad. But for some reason, big government is good. The media is incessant on this big bad drug company bull**** and that is my cue that drug companies must be good. Any time the media starts beating the drum, I run the other way. Man, why did you have to get me started.......Originally Posted by LakeMountD
08-20-2005, 02:07 PM
this article links 27,785 deaths with vioxx. Now lets assume for a second that this figure is somewhat accurate (and im sure it is grossly inflated) and do some math. out of 92.8 MILLION prescriptions, 27,785 supposed deaths occurred. This means that if you accept a Vioxx prescription there is a .029% chance you are going to get cardiac complications.
if i had chronic arthritis i would probably take vioxx and not worry about that .029%. And also, how many complications could have been avoided with a slightly lower presciption dose, exercise, better diet, or discontinuation of the drug after check ups where cardiac problems are detected? I think people need to stop blaming the pharmaceutical companies and take some godamn responsibility. Vioxx is not a bad thing, it helped 92.7999 million people with their arthritis problems.
how many people on this board are ephedra and ephedrine users? Im sure you dont think it should have been banned.
according to this article there are .67 deaths per 1 million ephedra users. Ephedra was banned. im not even going to try and figure out the percentage of deaths to users, the number would be too small. Now people want to do the same thing to vioxx? I think its time for people to do their own research on drugs, accept the risk, and only use the drug if they accept that risk. enough of this blame everyone else BS. Im sure there are a lot more than .67 deaths per 1 million liscensed drivers. Why dont we ban driving, and milk while were at it.
08-20-2005, 02:20 PM
the ban on ephedra was over turned due to the same arguement that you are using.. and yes people should take responsiblity for their actions BUT if you don't have all the informatin HOW do you expect anyone to make an informed choice?
08-20-2005, 03:00 PM
I've never even heard of that type of Leukemia. Hmm, sorry for the false information. but you've got to admit, the pharmaceutical industry is still lacking in the "cure" department.Originally Posted by Nullifidian
08-20-2005, 03:12 PM
Merck didn't have all the information until the study was completed, when it was, they found a statistical increase in heart risk only after 18 months use. Once they found that, they reported it to the FDA and voluntarily pulled the drug. When the FDA reconvened, they still voted by a majority to let the drug on the market. Merck released the information when they had it. Its interesting that supplements do not have to undergo any scrutiny, but yet drug makers are held to a level of scrutinty that even when they folow the FDAs very stringent guidelines, they can still get sued. If indeed we need to get all the information, we will wait forever because one keeps on discovering things (good and bad) about drugs long after they are approved. I guess I don't believe the problem in this country is too little regulation, I tend to believe there is too much. I don't think lawsuits will make drugs better, more innovative or come to market quicker. I do think they will make some lawyers very rich but I wonder where that money for the lawsuit will ultimately come from. I guess Merck could have sold vioxx as a supplement like superdol, conducted no clinical trials, never pulled it and we would all be happy to take it. But since its Merck, **** them I guess.....Originally Posted by Matthew D
08-20-2005, 03:13 PM
Yeah **** thos drug companies, we'd be all better off with leeches and ****. I'm with you manOriginally Posted by Viator
08-20-2005, 06:58 PM
Thanks, it's good someone said that. One has to wonder why an agency that's supposed to make us safer gets let off the hook, or as is more often the case gets more regulatory power and a higher budget everytime something gets through that hurts someone.Originally Posted by chuckymiller
And since when was life risk free? Burying a possible risk is inexcusable, but people still sue when side effects are well known and even advertised these days. Maybe if people were living healthier lifestyles they wouldn't have to pump so many borderline toxic chemicals into their systems as the years went on. Maybe if they understood that no amount of regulation or damages won in court will make them immortal they'd have a more reasonable persepctive on life. Maybe people could be less full of it, but I doubt it.
I wouldn't go that far, you find sleeze every place you look, private and public sector. Problem is people are so ill informed when it comes to science they think one study is all it takes to know the truth of anything, or one report of an adverse event. I can't count how many people I work with who flip when they see me even looking at an ephedrine bottle, but then pop twelve cold and sinus tabs a day because they don't feel good, and then tear ass into a their daily meal of McDonald's. Ill informed.The media is incessant on this big bad drug company bull**** and that is my cue that drug companies must be good. Any time the media starts beating the drum, I run the other way. Man, why did you have to get me started.......
08-20-2005, 11:18 PM
Haha - isnt that the truth!! I was talking to an older guy at work and I mentioned something about HRT. He immediately grimaced and said "I would never do that...that's STEROIDS!!!" Then I showed him that thread by Ageless and he walked away dumbfounded.I wouldn't go that far, you find sleeze every place you look, private and public sector. Problem is people are so ill informed when it comes to science they think one study is all it takes to know the truth of anything, or one report of an adverse event. I can't count how many people I work with who flip when they see me even looking at an ephedrine bottle, but then pop twelve cold and sinus tabs a day because they don't feel good, and then tear ass into a their daily meal of McDonald's. Ill informed.
08-20-2005, 11:21 PM
Ill informed with the help of the FDA and the drug companies. People aren't stupid or irresponsible for the most part, they are mislead.Originally Posted by CDB
Drug companies spend millions on advertising, half the time never even saying what the hell the drug is for. It's usually a montage of happy, healthy people enjoying life while a laundry list of side effects is stated in the background. Side effects that most often they claim were "also seen in placebo." But hey, don't worry, The FDA says it's ok, and the only research you need to do is to "go ask your doctor if death in a bottle is right for you." People think the FDA knows whats safe for them and why shouldn't they think that? Isn't that supposed to be their purpose?
Supplements encourage self research. Grab a bottle of anything you have at the house. Says right on it, "These statements have not been evaluated by the FDA." This is why people freak when they see you take ephedra. They are led to believe that the FDA knows all and that whatever your taking on your own is either poison or doesn't do anything because hey, if it was good for you the FDA would have a stamp on it and MERK would have some ******* in a sweater and a smile telling you to run to the doctor to see if it's right for you.
Prescription drugs should come with the label "Half ass looked into by your federal gov't." And stop giving people false security.
08-21-2005, 10:54 AM
CML is a rare form of leukemia.Originally Posted by Viator
What's crazy is that we are now finding out that it isn't as rare as originally thought. In the past there were about 20,000 cases of CML at any given point of time. THat's extremely small. The reason though that the number of cases were so low is because they died so friggin quick. CML kills very rapidly; it is a very aggressive form of cancer, not unlike small cell lung cancer.
However since Gleevac got released, the number of people living with CML has increased. The reason is that the folks who should have died are still alive. Typically CML, once diagnosed, kills in anywhere from a couple weeks to a few months. With Gleevac however, the cancer is typically cured with a month or so of treatment.
The thing with cancer though is that they never consider cancer "cured", they only consider it "in remission." So while Gleevac is considered a treatment, in reality it is the closest thing to a "cure" you will ever see with respect to cancer.
You can thank the FDA for the weird, uninformative advertisements. FDA regulations are VERY strict about pharmaceutical claims in DTC (direct to consumer) advertisements. Take Lamasil for example. In the original Lamasil commercial, a gient pill came down from above and when it landed, it squashed most of the little nail infection dudes and the rest ran away screaming. The FDA issued a warning letter, because they said this would cause the consumer to assume that the pill is 100% effective at KILLING the fungus. The FDA said that they may only show an advertisement depicting what happened for the lowest effective dose for the segment of the population it was least effective but still effective. SO they had to change the ad so that the pill landed and killed nothing, but the fungal dudes very slowly walked away.Drug companies spend millions on advertising, half the time never even saying what the hell the drug is for. It's usually a montage of happy, healthy people enjoying life while a laundry list of side effects is stated in the background. Side effects that most often they claim were "also seen in placebo." But hey, don't worry, The FDA says it's ok, and the only research you need to do is to "go ask your doctor if death in a bottle is right for you." People think the FDA knows whats safe for them and why shouldn't they think that? Isn't that supposed to be their purpose?
HOW RETARDED IS THAT?!
08-21-2005, 12:49 PM
08-21-2005, 01:20 PM
The thing was why did they attempt to take it to market before the overall study was complete? To me that is like driving a car off the lot with a mechanic sitting on the engine tighting down bolts... I know for the most part that all the chemists in the company are wanting to develop things that help people not hurt them but it seems that the "money-side" has managed to turn into the all righteous side. How much money is enough? Whatever happened to the thought that people had a responsiblity to each other?Originally Posted by chuckymiller
08-21-2005, 02:10 PM
I think the industry standard is 5 yrs in remission for a 'cured' status. Dying in the first month of the 6th from cancer doesn't change cured statistics.
Gleevac doesn't cure but seems to keep patients alive like insulin for diabetics. Its more profitable business model for patients to keep paying for drugs for the rest of their lives than to cure the disease.
You neglect to mention that the Bush administration castrated FDA's oversight capability by increasing the amount of red tape before the FDA can issue warning letters. The red tape has delayed the warning time by months thus letters are issued only after the broadcast cycle of an offending advertisement.Originally Posted by Nullifidian
The data from Vioxx studies were manipulated by big pharma to show only the favourable outcomes. The CLASS study published in JAMA only showed data from the first 6 months out of the 12-16month study. The next 6 months showed that subjects had more gastro bleeding on Vioxx but that was hidden. So big pharma knew about it all the while from day 1. The VIGOR study was manipulated as well.
08-21-2005, 04:38 PM
Actually I'd supporting simply getting rid of the FDA, because I don't think it serves any useful purpose that couldn't be gotten through other, less destructive means.Originally Posted by FOCUS
08-21-2005, 05:35 PM
Merck had completed all of their studies before they marketed the drug. The FDA decides which studies the companies must conduct, how they conduct them ,etc. Then, as part of their continued surveillance, companies are required to futher monitor for adverse events. In view of adverse events that come up in post-surveillance monitoring, the FDA or the company (or both) can decide to conduct further clinical trials. This is the case for vioxx. Merck decided to do additional post-marketing studies specifically powered to look for cardiovascular effects (along with some other things) in a post-marketing studies. The study showed an effect only after 18 months. As soon as it reached the point where an effect could be determined, Merck pulled the drug. The crazy thing is, the FDA never asked them to pull the drug. Later, when the FDA looked at all of the data, they still felt the drug was safe enough to be marketed!!! All drugs have side effects! Merck acted very ethically, going beyond even what the super strict FDA required. If every drug had to undergo the type of scrutiny that the trial lawyers would insist on, we would have no drugs on the market, because, believe me, no drug that works is always safe....get that, no drug. Doesn't McDonalds have a responsibility to not sell its McBurgers? Gun companies should not be able to sell guns, liquor store liquor, supplement manufacturers supplements, etc. Trust me, if you can get enough cases into the courts of Texas (or wherever), you can eventually bankrupt the manufacturers of anything. How many clinical studies have been done on Superdrol? How many double-blind, placebo controlled studies of any supplemnt have been done with the kind of studies the FDA companies requires of drug companies (three phases, proof of safety effiacacy and post marketing surveillance)? The FDA has one of the strictest set of guidelines of any drug approval agencies in the world, but what people need to remember is that, no drug is safe. Get it, no drug is safe. Sure, drug companies like to make money, does that make them bad? Which company in America does not try to make money, are they all bad? Quite simply, drug companies are more regulated then any other business that I know of. Every drug must be extensively scrutinized in many animal in human studies for both safety and efficacy before they can come on market. The process is already prohibitively expensive. If we decide we want to include additional studies, we will eventually end up with less drugs, at greater cost, and at the end of the day will still be faced with the fact that no drug is safe.Originally Posted by Matthew D
All drugs have side effects. It is, and always has been a cost benefit analysis. If you want to drive a "safe" car, force all manufacturers to put 600 lb titanium bumbers on them and force them all to have roll cages. It will cost 10,000 dollars more per car, but hey, we all must be safe right? As for me, I don't want to buy that car, I'd rather have more choice than less but hey, we increasingly live in a nanny state where we want everything to be "safe": and decided for us....won't people be surprised that even after all their choices are removed, all their freedom (along with their responsibility) is gone, they will still not be safe, and will have sacrificed all their choice and freedom for nothing.
08-21-2005, 05:42 PM
I quit.. there is no use trying to argue with you on this.. I know that there risks with any medications but at the same time I do know that FDA has also stated that they do not have the time nor the personel to keep up with the studies that are being conducted. I also know that MOST of the adverse reaction studies have been suppressed by major drug companies and if you think that they are all operating for the public good then great for you..
08-21-2005, 08:29 PM
Damn CDB, are you a libertarian? You're beating me to the punch on these things.Originally Posted by CDB
Our world is quite imperfect, and mistakes will happen. The FDA can/will **** up, and the same goes for drug companies. However, the existence of an FDA kills the market for competing, independent QA comissions, and provides a false sense of security to consumers. In this particular circumstance, it makes it hard to tell who, if anybody, is at fault.
In an unregulated market, MERCK would only be responsible for living up to their claims. If they release a product they claim to be totally safe and **** up, that's their ****. If, on the other hand, they release with incomplete clinical trial data and somebody buys the goods and croaks, that's the fault of the corpse. This would mean there would be a very strong impetus for drug companies to not lie, and a very strong impetus for consumers to play it safe. Right now, food and drugs are little more than a lawyer's playground.
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