Health advisers say the popular drug's risks outweigh its benefits
Article Source: msnbc.com
from:msnbc.comPanel wants Avastin withdrawn for breast cancer
Seeded on Tue Jul 20, 2010 3:39 PM EDT (msnbc.com)
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Why was it approved and used in the first place? The FDA does a TERRIBLE job protecting the publ;ic from run-amuck drug companies who kill people and can afford the law-suits. Can we afford to kill innocent people and call it approved medicine?
The drug companies use their own tests and results and then argue and bribe and cajole and nag to get their garbage passed to a waiting public. If you don't believe me, look at Aspartame. It is POISON! And on the market everywhere with a little warning label for a few unfortunates who dare to use it, despite the teensy words.
When are we going to insist that drug companies spend their billions on research and development and stop peddling their trash to the unsuspecting public? In most industrial nations, it is unheard of to advertise drugs to patients. They are controlled substances, treated like cigarettes and pot and alcohol.
A patient goes to a DOCTOR who recommends a drug that they have not been bribed into delivering. In America, it is like a pimp and his hoochie--getting you hooked and then making you pay and pay and THEN not letting you go when you relaize it is killing you.
This has got to stop! Drug companies are killing us for profit.
The FDA over the past 40 years has come to be dominated by physicians with only an MD and absolutely no credentials, training, or skills in designing, conducting, or evaluating drug and medical device trials. The new Commissioner has only an MD and no experience with drug evaluations expertise. The previous Commissioner was an MD, JD --- I guess this means he knew nothing either, but could lie about it.
This means that the physicians who staff the FDA must rely on the drug companies to design, conduct, and evaluate their own drug trials. And this is much like setting foxes to guard all the hen houses. The drug companies use this as a license to kill --- literally. In addition, the drug companies are allowed to suppress any data or part of data that does not support their application for approval. For example, the Avandia trials simply picked and chose among the studies that showed the greatest benefits and the lowest heart attacks. I took Vioxxx for a while before it was removed from the market. That drug company simply labeled people who died of heart attacks as "voluntarily withdrew from program."
Here's an interesting factoid: Over 30% of all drugs approved by the FDA perform no better than a placebo. So, a third of the drugs are like sugar pills but with side effects.
Another factoid: The FDA is forbidden to compare drugs so see which is the more effective or the more cost effective. This results in new versions of drugs, such as Nexium, that are no better than their generic predecessors but cost much, much more. The FDA makes its decisions based solely on what drug companies tell them about safety. Little attention is paid to whether the drug actually works or not. No attention is paid to whether the disease it actually treats even exists (restless leg syndrome) or if the drug does anything useful (Avastin) or if it is already available in a better form (they recently approved several versions of prescription-only 81mg enteric aspirin at about $1.00 a tablet.)
Most physicians working for the FDA have financial ties to the drug and medical equipment and the rest of the for-profit medical industry. They are required by law to disclose these connections, but over 80% have not done so. It is not unusual for a physician at the FDA to take home twice his FDA salary in "perks" from drug companies and others including speaking fees, seminars at resorts, free lunches, cars, airline tickets, benefits for his/her family, and many other ways of getting them money without a 1099.
The fixes are simple. Fire any FDA physician who does not have the proper research credentials. Under some circumstances an MD, MPH might be acceptable, but generally, almost every job filled by a physician should have a PhD or an MD, PhD with demonstrated specific research skills. Fire any FDA employee taking "perks" from the for-profit medical industry, whether it is disclosed or not. This should be a zero-tolerance policy --- not even a ball point pen.
Re-mission the FDA to consider safety, efficacy, and cost effectiveness. Drugs must meet high standards in all three to be approved. The drug trials must be designed by the FDA, conducted under the direct supervision of the FDA, and evaluated by the FDA with no assistance from the manufacturer. All data must be considered for any drug application.
One reason that this has come about is that drug companies do not develop drugs --- surprise! They lie. Only one of the top 100-selling drugs was developed by a major drug company. Drugs are initially found through studies funded by the National Institutes of Health --- the taxpayer --- by academics. The academics discover the drugs, but have no resources to develop and test them. They either sell the patents or their university sells the patents to groups who assemble venture capital to develop and test the drug. Then in steps big pharma. They go to the company and tell them, quite bluntly, that only big pharma has the "connections" to get drugs approved and that not only will the small company never get it approved on their own, that big pharma companies can often block their efforts for years. (This includes generic manufacturers who can also have low cost versions of drugs blocked for decades by big pharma using FDA help.) The smaller company invariably sells the drug to big pharma, who has the FDA approve it for them.
In this country medical malpractice is the fifth leading cause of death. Inappropriate medicines, medicines with undisclosed side effects, or improperly tested drugs account for a significant percentage of medical malpractice deaths. Yet no manufacturer, no physician, or no FDA employee ever goes to jail. Funny how that works.
This something that can be stopped, but not until there is such a public outcry that the voices of the people drown out the money interests. Avastin made $2.3 million dollars from useless breast cancer treatments. It gave people false hope. But some part of that money bought influence at the FDA and in Congress. How many more drugs do we have to go through before we call it to a halt?
Make Roche give all the money back. They sold snake oil. They thought it was helpful--yada, yada. They sold something useless. Refund every cent.
My mother has taken this drug and it has helped her tremendously - yes there are side effects - but what chemo doesn't have side effects - stopping tumor growth is huge! How can they say that stopping tumor growth doesn't extend life? My mom has long periods of time where the tumors are inactive - largely thanks to this drug - they just want to make it unavailable to the breast cancer population so that you have to pay for it yourself, instead of your insurance company paying for it.
The FDA allows drugs onto the market, under an accelerated approval, if some benefit has been shown ... for example, tumor shrinkage. The sad truth is that quantifying overall survival is a long and costly process, hence the pre-approval. If you withhold potentially beneficial treatments from the public until overall survival can be measured you will also be "hurting" the public by denying access. So, we will see these types of things from time to time. There is no free lunch here, and no clear optimal strategy.
The assumption that tumor shrinkage automatically means improved quality of life or extension of life is called "surrogate endpoint testing." The drug company shows tumor shrinkage and the rest of the equation is assumed to be true. Mortality statistics are some of the easiest numbers to collect. It is very easy to measure the time between diagnosis and death for groups with and without a given treatment. (It's hugely better if no one knows which patients gets which.) That's why a double-blind clinical trial that uses mortality statistics is the gold standard. But with surrogate endpoint trials, the patient knows and many benefit, not from the drug, but from the placebo effect.
Some drugs show an improvement, but then have an offsetting cost. For example, Aricept, a milti-billion dollar Alzheimer's drug appears to very slightly slow the progression of Alzheimer's for about six months then it stops working. That would be great except that most of the time the drug is stopped when it ceases to work. Immediately the diseases progresses rapidly for a while and the six months are quickly given back and then some. In the end, the result is exactly the same. Except that a great deal of money has changed hands from the victim's family to the drug company.
Victim's families grasp at straws to give their loved one the best possible care. And greedy drug companies know that and use it to their benefit. Luckily I am married to a gerontologist and don't have to worry so much about it. She will make sure that she acts as a buffer between me and the drug companies if I ever get into that position.
I am not defending the drug companies. Mortality statistics are not easy to collect because you have to wait until a large number of people have died in your study before you can make a decision.
The FDA does a terrible job because the same people that sit on these panels have ties to the drug company themselves....I am sick and damn tired of drug comnpanies getting out of control, from their influence over doctors to their nonstop television advertisement. The last thing I need is anyone but my doctor telling me what prescriptions I need!!
This is a remarkable cancer drug that destroyed a sizeable tumor in my lung. It has worked effectively on other cancers as well and, naturally it was tried for breast cancer. Not all drugs work well on all types of cancer... it was worth testing though.
Some good comes from Research. AVASTIN may have proved to be in effective in treating Breast Cancer, but, it has been shown to improve conditions in the Eye treating Age Related Macular Degeneration. I have had two injections of the drug in my Eye to stop hemorageing and reduce swelling of the Macular. So don't be so QUICK to damn Roche for it's attempt to find a cure for Breast Cancer, when it has developed AVASTIN to treat AEMD! Thank You Roche
This is a remarkable cancer drug that destroyed a sizeable tumor in my lung. It has worked effectively on other cancers as well and, naturally, it was tried for breast cancer. Not all drugs work well on all types of cancer... it was worth testing though.
Yes, these companies are in it for the money but look at the other drugs that have benefited everyone. Avastin is a great drug for other disease like degenerative blindness. Quit your bitching because we all know you would be the first one in line if you thought it would save your sorry ass.
My mother had ovarian cancer. She did very well on all her chemotherapy, rarely getting sick; hardly any side effects other than hair loss. Things looked good for awhile & then her CA-125 test came back higher. Her doc decided to "try" Avastin on her, despite it not being approved for ovarian cancer. That was in October. She got so sick, and in December, went to the ER with extreme pain. She never made it out & died on 12/26/09. I firmly believe it had a lot to do with being on Avastin cause before that, she was doing so well. If Avastin has proved to work with other types of cancer, great; keep it available for those. But if it doesn't prove the same results for breast cancer, then approval should be removed. And above all, docs should NOT allow it to be used for cancer treatment that it has not been FDA approved for.
Sorry to hear about your mother. It seems strange, but doctors prescribe drugs off label, the only restrictions are that the drug companies cannot market drugs for uses that the FDA has not approved it for. Going to a doctor can sometimes seem like the wild west.
statsGuy,
Physicians almost never prescribe an off-label use of the drug on their own hook. It is simply too risky and too easy a way to end up in an unwinnable lawsuit and lose your license. Physicians are almost always encouraged to prescribe off-label uses of drug by drug company reps. There have been billions in fines for this in the last year. Did you know that for 5 straight years within the last decade, that every University of Kentucky cheerleader who graduated got a job as a drug rep?
Avastin helped reverse my Diabetic Retinopathy, which had led to Neuro-Retinitis. I was at about a 30% loss of my normal vision when they gave me the injections (which my insurance refused to cover because the FDA had not approved for the drug to be used for THAT purpose) and between the injections and the laser treatment I'm back up to 20/40 without glasses, 20/25 with glasses. Avastin is one of the few drugs that is worth the hype.
My mother has inoperable lung cancer stage 4 diagnosed a year and a half ago. The Avastin has helped to shrink the tumor in her lung and also disolved the tumors in her brain. of course she had just been laid off her job she was at for 18 years and was on Cobra when diagnosed. Now she has a new insurance at $1700.00 a month and they have decided they are not going to cover the Avastin. She is only 63 years old.
My point as I was reading other stories, in my moms case, the Avastin has worked very well. My sister in law has a friend that was diagnosed 3 years ago with terminal brain cancer and was told he had weeks to live. He started Avastin and is still alive doing well.
My mother was diagnosed with Stage 4 Lung Cancer back in the winter of 2006. She was given less than three months to live due to the severity and how much the cancer had spread. They did not do any operations and did no radiation therapy. All that was done was chemotherapy, Avastin. After four months, already breaking her original exporation date the doctors gave her, her PET scan came back with no active cancer. She continued treatments and at the age of 43 almost two years later she had a heart attack because one of her arteries collapsed. The only thing the doctors came up with was that massive doses of Avastin had caused the weaken of the artery walls. That was two years ago. She is living well and healthy; cancer free. Although Avastin did have a major side effect on her, it also saved her life. I hope they approve the drug because having my mom around just one more day is worth the risk (she thinks so too!)
I hope that everyone who reads theses stories sees that approving (read all of the good things that this drug can do) and not approving (look at all of the bad as well) a drug is not the easiest thing to do. I am getting so tired of people blaming the medical system for decisions that must be made with incomplete information.
People trust that FDA approval without ever being informed that it's a approval is accelerated & tentative on followup studies. The FDA is supposed to be looking out for us, the patients!
IF it is the case that an FDA approval was accelerated & tentative...the patient offered that medication has a right to know! Doctors should be held accountable for informing their patients of any drug's status as an accelerated acceptance & tentative status. Patients receiving the medicine should have to sign a form acknowledging that they were informed it was approved tentative on further studies.
It seems that continually every month a new lawsuit ad run across our tv with new cases of FDA approved drugs causing death and/or severe side effects. How much money did the drug company make before they get their
Far fewer patients would suffer extreme side effects of medications if the FDA did it's job correctly the first time! Seriously~ What woman would take a birth control pills she knew was only tentatively approved? Far fewer would end up with the FDA approved medicine destroying her heart valves? Or what person wants to take an FDA tentatively approved medication for asthma? Far fewer would have it cause Inflammatory Bowel Disease or Chrons disease?
NO...the FDA is supposed to determine if the benefits outway the risks BEFORE releasing it to the public. Far more money comes in than they end up paying out in lawsuits! The FDA accelerated approval process builds in a lower standard of testing, a lower standard for acceptance, and a set of immoral behaviors that American patients should not be subjected to.
ZERO patients I know would trade a painful lifelong & sometimes life threatening disorder for a new medication based solely on the company making it says it has some potential benefits!
Maybe somebody needs to study the FDA's accellerated drug acceptance program? What are the percentage of these drugs that are ultimately are pulled back off the market due to severe adverse side effects? What percentage of these drugs are like this latest drug where the side effects were known but it turns out that the benefits have been over inflated? What percentage of money did the manufacturers ultimately profit, despite lawsuits, before their drug was yanked?
It is my personal opinion that shis FDA accelerated drug approval tentative on followup studies should be yanked, permenantly! ALL drugs should be studied completely before their release. Patients have a right to know what the long term side effects really are! Why? To save patients from unnecessary side effects from drugs with only a slight chance of helping them. To save patients lives!
Here is a study.
http://content.healthaffairs.org/cgi/content/full/24/1/67
What if, in a cancer trial, I show you that the drug reduced tumor size? Well that is a good thing, but it might not increase your survivability. The problem is that withholding a drug from the public when you know that the drug can help may be unethical. The accelerated approval process is a major ethical dilemma.
The FDA hasn't approved Avastin to be used for any ocular treatments, not just Diabetic Retinopathy. It is used as an "off label" purpose. Medicare just recently, within the past 2 years, began to recognize it as a safe and effective treatment for many ocular diseases, including Diabetic Retinopathy, along with Age Related Macular Degeneration and several others. It takes a while for private insurance companies to follow suit. Avastin is widely used for ocular diseases with great results with very few side effects.
Nothing's changed since World War II.................they're still experimenting on people!
Yep
let's see. how many years have we been donating and raising money for breast cancer? /breast cancer awareness? maybe 30 years. And in 30+ years with all the research and scientific minds we are no closer to a cure?
So, sounds like somewhere someone is making a huge huge huge profit on breast cancer research. Why in god's name should anyone ever come up with a cure if not having one is so profitable. I bet if it was testicluar cancer for all these years killing and maiming men, the cure would have been researched, found and in place for at least 25 of those 30 years!!!
I too have benefited from Avasatin. I am a stage 4 breast cancer survivor who is "clean" thanks to a clinical trial involving Avastin and Taxol. As my Drs. would say when I asked if other patients were doing as well as I was: What does it matter, it's working for you. I know this sounds small minded and selfish but if this drug saves one life isn't it worth it??
me too!!I am a stage 4 breast cancer survivor and I believe we were in the same study. Abraxane and Avastin. The tumors in by breast and liver shrank and disappeared. I have had no evidence of disease for 2 years. i know 2 years may not be long for some people, but it certainly is to me and my family. The large lump in my breast is completely gone because of these 2 drugs!! This study about avastin reminds me of the mammogram study not to long ago. Only women over 50 need mammograms--hogwash!! Unfortunately I think this whole thing is about money.
Coming from someone who has been through the breast cancer medications, and being a 3 year survivor, it may benefit some but not others. I took Taxol and Adriamyacin, standard medications and am alive today. But if the drug does not work for some but for others whose to say it should be removed by the FDA?
I have seen Avastin have severe side effects, mainly bleeding and high blood pressure, but it adds to the effectiveness of other chemotherapy drugs too. I wonder how much of the pressure to drop it is motivated by political appointees like the ones that said that women under 50 did not need mammograms. It is a very expensive drug and this may or may not be an effort to prevent its use because of expense. Cure is not always the goal. Quality of life is more important even if its for a few more weeks or months.
I AGREE !!!!
I took part in an Avastin clinical trial. Diagnosed with Stage II breast cancer. I took the drug for 11 months in addition to the standard breast cancer protocol. I had some side effects that really knocked me to the ground. I am glad though that I participated - if we don't have clinical trials, how are we going to know what works??
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