Some are calling for popular diabetes drug Avandia to be withdrawn
Article Source: msnbc.com
from:msnbc.comWhen is a drug too risky to stay on the market?
Seeded on Wed Jun 30, 2010 5:45 PM EDT (msnbc.com)
- msnbc.com sites & shows:
- TODAY
- Rock Center
- Nightly News
- Meet the Press
- Dateline
- Morning Joe
- Hardball
- Ed
- Maddow
- Last Word
- msnbc tv
Leave a Comment:
Under Bush's FDA, there were many MANY drugs approved that were downright dangerous!! All you have to do is listen to any drug commercial (which I think should be abolished!!) and you hear about all the side effects that are detrimental to good health AND some that explictly mention DEATH! I sure hope that is addressed...and soon! It should NOT require any legislation which the GOP would filibuster anyway---- just new FDA rules!
Virtually every drug out there has death as a possible side effect. This includes things as simple as aspirin and acetaminophen. The side effects mentioned in the ads are for legal reasons to keep the lawyers from suing for non-disclosureof risk. In reality, the odds on most of those side effects, particularly the more severe ones, is extremely low. The key with any drug is to balance the good a drug does against the possible side effects and the likelihood of those side effects occurring. The availability of other treatments and the risks of those treatments is also a factor in the decision.
Vaccines that virtually every child is given, that save countless lives, can and do cause severe side effects and even kill a very small percentage of children. The fact that a small handful of children die or are permanently harmed by vaccines does not justify doing away with vaccines. It is a clear case of the good far outweighing the bad. Why can't people understand this same metric applying to drugs. I partly blame our media for sensationalizing the small handful of cases and lead people believe that the severe side effects are a common occurrence. There are some cases where the drugs should be pulled off the market, but there are some where it is an over reaction. There was a push to pull Celebrex off the market around the same time as the Vioxx problems came to light, that thankfully failed. This push was based on a few adverse reactions in patients that had been on the drug far longer than recommended and at very high doses as well as the fact that Celebrex was in the same class of drugs as Vioxx. Prescribing the drug as intended by the manufacturer was safe. It was a case of doctors over-prescribing in both dosage and length of use that should have caused malpractice claims, not claims against the drug company. Luckily, cooler heads prevailed and Celebrex stayed on the market, helping many people including me.
I do, however, agree with you on drug ads. These ads push people to ask their doctors for medications they probably don't even need. People will get convinced that some med is going to help them with symptoms that they think they have when the symptoms may not even be related to the disease the drug is designed to treat. Sometimes the symptoms are even entirely in their head. People will go to different doctors until they find one that will give them the prescription.
There has also been an increasing tendency for drug companies to come up with drugs to treat made up diseases. An example of this is the drug to treat eyelashes that are to thin. This is not a disease but a physical trait. Some people just have longer, thicker eyelashes than others. There is no medical necessity for most of the people being diagnosed to have any more eyelashes than they have. Of course the drug companies, in cahoots with doctors, invent this as a disease so they can get their drug as a prescription item and covered by insurance. Without inventing the disease, they would have to market the product as the cosmetic it really is. As a cosmetic, people would not be willing to pay the high costs for this 'treatment', but as a drug all people have to pay is their co-pay. This gets people to go to doctors recommended by the drug company's web site (yes there is a prominent 'find a doctor' tool on the site) to be diagnosed with this made up disease and get a prescription for the drug. Of course this is brought to us by the same people who came up with Botox, so what do you expect.
BTW - Your cheap shots against the 'Bush FDA' show that you are a typical inane poster on this sight that looks for a political angle to every story, looking to blame one party or the other for everything that happens in the world. The problems with the FDA drug approval process goes back well before even Bush Sr. took office and both Democratic and Republican administrations and Congresses have failed to fix the problems.
Like everything else, lawyers are our biggest enemy. All it takes is a handful of people who are not compatible with a drug, it will be taken off the market for fear of more lawsuits. Millions of satisfied users will be denied pain relief because a few people and some greedy lawyer. It goes beyond drugs. Have you noticed there aren't any diving boards anymore? Even something as simple as a dog leash is no longer available in the US because someone was stupid enough to have the leash wrapped around a finger while walking a Saint Bernard, and had the finger severed as the big dog ran off. It pathetic how we are in fear of lawyers.
You, sir, are beyond ignorant with no knowledge of the law. Lawyers can only follow and advocate for law already on the books. Blame your legislators and Congress for writing the laws.
Also, through Congress, we have placed the duty to decide whether a drug is safe in the hands of the FDA, not in your individual balancing of the harms/sacrifice 5 for the 1,000 mentality. There is nothing here to indicate a "fear of lawyers." The FDA operates as written in the FDCA or Food, Drug and Cosmetics Act. Head over to fda . gov if you'd like to learn something.
Oh, and I hope every lawyer reads your comment, so that in the future when you actually need service from a learned professional you are duly denied.
You describe an ideal world, but this world is far from ideal. Yes, Congress and legislators write the laws, but what is the actual percentage of politicians who do NOT have law degrees? And how many of them have no staff members with law degrees or at least some law school? You fool yourself, and attempt to fool everyone else, when you state that "lawyers can only follow and advocate for law already on the books."
Of course there is a fear of lawyers, lawyers who are not legislators and not the staff members of legislators. There is always a fear of litigation.
JobSeaker makes absolute sense, and judging by his/her examples, if probably someone with a diagnosis of a chronic illness who has had effective (for him/her and for most people) meds yanked off the market because one or two individuals ignored the potential risks of a given med, and then sued anyone and everyone who could have anything do with the med when they experienced one of the side effects. Yes, that precise scenario happens, and all too frequently.
Any drug with chemicals should be in question. That's just about ALL of them! Chemicals do not belong in our bodies, they cause SIDE EFFECTS!
The problem is, the natural alternatives do not have a voice. But we have the internet to educate us and we have a choice.
I'm a healthy 65 yr old who tries to stay away from chemicals in our water, food and medicine. These days, it's not that easy, but it's fun.
Be well everyone!
You won't like it and you'll refuse to believe it, but there NOTHING that is safe for everyone. Yes, that means that "natural" remedies are as likely to cause some type of harm, as likely to negatively interact with one another and with anything else, as are pharmaceuticals.
You obviously have a genetic profile that makes you less prone to chronic illnesses than do many others. That's a HUGE component in being able to stay healthy, in being able to avoid medicine of any ilk.
By the way..............water is a chemical.
The sleeping medication, Ambien, needs to be added to this list. Even though it may not "directly" result in a death, the side effects suffered by many people are extremely dangerous. Until a person has had a resulting side effect from Ambien, a person does not really know the horrifying effect it can have.
I'm tired of hearing about people suing because they took a medication that their doctor precribed and then they have a side affect that they probably knew about before taking the drug. All medications have side affects, what are we going to do pull every medication off the shelf just because of side affects. Alot of drugs on the mark cause heart problems, but in most case people had a heart condition they didn't know about before even starting the medication. If you listen to commercials on TV, a lot of side affects are pretty serious, you as the patient need to decide, would I rather live without the medication, or use the medication to obtain a better quality of life. I you choose the latter, then expect some side affects, but don't blame the medication, the medication is probably do its job, it just that you cannot tolerate the drug. I don't like taking medications and I won't take one that will cause a adverse side affect, but if its mild I will consider it. I take pravastatin and I think it causing me muscle pain but that is a small price to pay to get my cholesterol down which it does. People check into the medication prior to taking it, and ask yourself, is it worth the side affects, or will it improve my life.
They forgot to mention that one criteria is who got promised a high paying job with a drug company at the FDA. The FDA is full of flexians who come from industry to get drugs passed and then go back to high paying jobs when that mission is accomplished. This has gone on for decades.
They are recommending Actos as a sub for this drug. I almost died from taking Actos as have several others. I stopped taking it, and my legs that had swollen to three times their size and the blisters that had developed that were seeping all returned to normal. My doctor did not want me off the drug, so I went to a naturopathic doctor (a doctor who takes all the same courses an MD takes, but learns to treat with natural remedies). He took time to investigate Actos, and took me off of it. I'd be dead by now had I not stopped taking it. Alot of the drugs on the market today are synthetics of natural things. But there is only money for the drug companies if they produce the synthetics, of course. My ND in our state can prescribe drugs from Big Pharma and does when he thinks it's necessary. Yes, just about anything can have a side effects, but when I am experiencing something that is caused by a drug, I sure don't want to continue to take that drug!
By the way, I read that the drug companies pay the FDA about 400 billion a year to get their drugs approved. Doesn't seem right to me.
Avandia killed my mother. She was prescribed the drug in July and by April was dead. During the time she was diaganozed as a Type 2 Diabetic she regularly saw her doctor and the comment was her heart was very strong. Then she developed congestive heart failure and her blood pressure kept dropping until it killed her. A month after her death the first reports of problems with Avandia surfaced. If I knew then what I know now she would never have taken Avandia. Most likely she would still be here.
Remember, people take drugs because there's something wrong with the way their body functions. If they have impaired liver or kidney function, that's going to affect the way they metabolize drugs, so their response to medications can be unpredictable - especially if they're taking multiple drugs. People - including doctors - don't always realize the immense complexity of the millions of biochemical processes occurring in our bodies every second, and there are still plenty of processes we don't fully understand. A couple of examples I can think of are the role of Vitamin D in immunity and the true nature of all the different varieties of cholesterol. Doctors and researches want to assure us that we can all live to a healthy old age, but without a comprehensive understanding of what really goes on inside our cells, new drugs are inevitably a little risky until enough data has been analyzed (after millions of doses have been taken) to gain a true picture of what they actually do.
Lawyers are our only hope of getting these dangerous drugs off the market. I was badly injured by ONE dose of a popular drug, Lupron. This drug has victims' support groups all over the internet but the FDA has been very slow to investigate. It is estimated that 1 out of 4 Lupron users have PERMANENT side effects, so it is not a "few" people. It is also acknowledged by everyone that Lupron is not a cure for any illness. Yet it is amazingly difficult to find a lawyer. Trust me, some day you will need a lawyer for something. Greed is the drug companies who are concealing complaints and data from injured and dead patients.
People need to wake up to the all the side effects of all these drugs flooding our society. try Acupuncture for pain relief and many other ailments. It's a natural, effective method without side effects. The Army's Surgeon general is recommending it for pain relief in stead of all the drugs. the drugs cause suicide and violent behavior as well as other side effects. If we as a society start to pay attention, we'll seek out other treatments before reaching for the pills.