Breast Cancer Drug Raises Blood Clot ...

Breast Cancer Drug Raises Blood Clot Risk, Should Have 'Black Box' Warning, JAMA Study Says

There are 15 comments on the MediLexicon story from Nov 21, 2008, titled Breast Cancer Drug Raises Blood Clot Risk, Should Have 'Black Box' Warning, JAMA Study Says. In it, MediLexicon reports that:

Genentech 's cancer drug Avastin -- which FDA approved in February for treatment of advanced breast cancer -- increases a patient's risk of developing blood clots in veins, a condition known as venous ...

Join the discussion below, or Read more at MediLexicon.

Since: Dec 05

Irvington, NJ

#1 Nov 21, 2008
The fact that proving efficacy and toxicity in one situation does nothing to prove efficacy and toxicity in any other situation. This is why the FDA demands clinical trials showing data for each and every indication relating to drugs.

Therapy-related, late onset sequelae are becoming a real problem. Many of these new targeted therapies often get a pass on toxicities because they are just so darn cool (Herceptin in the adjuvant setting is another example).

In cancer medicine, it's not a case of throwing targeted drugs at the problem. The problem is that few drugs work the way oncologists think and few of them take the time to think through what it is they are using them for. It's hard to tell a doctor to tatchet back on the anti-VEGF drug they're using when the disease setting is stage IV cancer.

There are good sides and bad sides to all drugs. What needs to be learned, and obviously sometimes the hard way, is how do drugs work. This is particularly true when they are biologics, they can be working in ways and speed that scientists weren't used to. It is a learning process and it can be a painful one.

Maybe we should have the drug makers put the warnings on those cute little ink pens instead of the company's mascot and drug names so they can remember what can go wrong while writing these therapies. Which is more important to remember, the drug company mascot or the fatal side effects?
Gail Perry

Spring Hill, FL

#2 Nov 21, 2008
Actually, comparing Herceptin and Avastin is quite intellectually dishonest. Herceptin has been proven to save many lives. The permanent side effects from it are actually quite uncommon. Considering what Herceptin treats -- one of the more aggressive forms of breast cancer -- it is remarkably safe, effective and free of side effects. It's not completely, 100% innocuous 100% of the time, but neither is plain old water. You can die from drinking too much water. One baby aspirin a day put my husband in the hospital with a bleeding ulcer, but ... he wasn't typical, and it doesn't mean that no one should take aspirin. It meant that it was a bad idea for him. Unfortunately his doctor didn't have a crystal ball, so he went with the best advice he could give.

OF COURSE there are good sides and bad sides to all drugs. The notion that oncologists will forget about this is absurd. This report is a NEW finding, and it's an important one, and there are no "bad guys" in this story. Unfortunately at the current time virtually all treatments we have for cancer have some risk involved, but it still beats the alternative.

I think this statement is particularly absurd:

"The problem is that few drugs work the way oncologists think and few of them take the time to think through what it is they are using them for."

ONCOLOGISTS don't "think through what it is they are using them for??" Ridiculous. They go with the best information they have.

Since: Dec 05

Irvington, NJ

#3 Nov 21, 2008
Herceptin, the poster child for genomic personalized medicine, by measuring a gene that confers a tumor's susceptibility to the drug. However, seventy percent of patients do not respond to Herceptin and resistance develops in virtually all patients. This fact contrasts with the glowing reports on Herceptin emanating from the financial and medical tabloids.

More importantly, according to Decision Resources, one of the world's leading research and advisory firms for pharmaceutical issues, found that ninety-one percent of oncologists stated that intravenous cancer therapies, like Herceptin, are more profitable than oral therapies. In fact, fifty-eight percent of oncologists say they would favor IV Herceptin over any other equally effacious oral drug because administration of IV drugs remains an important source of income for their practices.

And then there is the studies at Dana Farber Cancer Institute that suggested a potentially very serious weakness in the drug, the problem with central nervous system (CNS) metastasis. Thirty-four percent of metastatic breast cancer patients with Her-2 overexpressing tumors developed CNS metastasis in spite of the fact that their disease was responding to treatment elsewhere in the body.
Gail Perry

Spring Hill, FL

#4 Nov 22, 2008
"Herceptin, the poster child for genomic personalized medicine, by measuring a gene that confers a tumor's susceptibility to the drug. However, seventy percent of patients do not respond to Herceptin and resistance develops in virtually all patients. This fact contrasts with the glowing reports on Herceptin emanating from the financial and medical tabloids."

Actually it's about 50%, and no, they don't know why some women don't respond, but it's still an important tool in our arsenal.

There isn't a "problem with mets to the brain and Herceptin. It's just that -- like many drugs -- it doesn't cross the blood/brain barrier.

In other words, Herceptin is not all things to all people. I had to pay for every penny of it myself. I looked at the research and chose to spend my personal money on it.

Why you distort the facts I have no idea, but the fact that Herceptin does not cross into the brain does not make it a bad drug. Its primary use is to prevent mets to begin with.

I don't care what is more "profitable." There is no oral medicine that does what Herceptin does. There are other oral meds, such as the AI's, but they work in entirely different ways. Once again you are distorting for some reason I can't fathom.

If there's anyone reading this who is faced with deciding whether to use Herceptin or not, PLEASE consider that people can say anything online for whatever reasons they want. Their agenda may or may not be to your benefit.

Since: Dec 05

Irvington, NJ

#5 Nov 28, 2008
No one has the right answers except the individual cancer sufferer themselves. Postings on blogs can provide input, but in the end the individual and their family have to figure it out for themselves. My contribution can and does stand on its quality. I am quite well versed in the literature as many oncologists and better versed than some.

Not all women will benefit from Herceptin. Some will be harmed. Maybe time will show more harm than benefit. But for now, the balancing act has to be achieved and the decisions taken by the individual. Staying positive is helpful, but pabulum seldom adds a day to a cancer patient's life. Being as informed as you can be is very important, and my postings are a vital part in helping build the big picture.

Some of those with cancer may find what I write is very sharp and intimidating, even to experts. It's a no-nonsense, sometimes harsh and honest writing style. Cancer patients need informed opinion good, bad or indifferent. Some, like Gail, will misinterpret my intent, but indiscriminately spoken words without substance and flamming commentary is not constructive advice.
Gail Perry

Spring Hill, FL

#6 Nov 28, 2008
Yes, gdp. We KNOW that not everyone will benefit from Herceptin, but in fact, long-term, the only risky side-effect from Herceptin is temporary. It is a little scary because it can appear some years after it was used, but ... it also fades.

And it saves a LOT of lives. It is just WRONG of you to try to scare people about Herceptin just so you can perpetuate the myth that you were right.

There's nothing either sharp or intimidating about what you write, but for some reason you have a bias against standard cancer treatments. I am not misinterpreting your intent. I don't KNOW your intent. i can only judge by your words, and your words are often biased and inaccurate.

There's nothing inflammatory about my comments, but you often get insulting when I disagree with you.

I agree that you did not give constructive advice here. Folks, of all the treatments for breast cancer -- chemotherapy, AI's, radiation, and Herceptin -- Herceptin is by far the easiest to tolerate. It won't work for everyone but unfortunately nothing works for everyone. Talk to your doctor. Ask about the research. Ask about what tests you should have done, and how often. Ask how it works. Gather all the information you can. I did and I was very glad I did.

Since: Dec 05

Irvington, NJ

#7 Nov 28, 2008
If oncologists would think beforehand, learn more to recognize the toxicities of adjunctive drugs, and take the time to think through what it is they are using them for, it could drastically reduce having to endure toxicity and allow the patient to experience significantly increased survival.

Cancer sufferers are taking doses of expensive and potentially toxic treatments that are possibly well in excess of what they need. Many of the highly expensive "targeted" cancer drugs (Herceptin, Avastin and Rituximab) may be just as effective and produce fewer side effects if taken over shorter periods and in lower doses.

However, it seems that pharmaceutical companies are attracted to studies looking at the maximum tolerated dose of any treatments. A search is needed for minimum effective doses of these treatments and should be one of the key goals of cancer research.

One must be objective and decide at what point the benefits of drugs truly outweigh the risks they present. For some people the risks may be acceptable, for others, not.
Gail Perry

Spring Hill, FL

#8 Nov 28, 2008
"If oncologists would think beforehand"
Of course, gdp. They're all a bunch of impulsive yahoos. Do you know how ... silly ... what you said sounds?
You REALLY think that oncologists of all people don't know chemotherapy is toxic?
"
Cancer sufferers are taking doses of expensive and potentially toxic treatments that are possibly well in excess of what they need."
POSSIBLY??? But you don't know, do you. Folks, the oncologists are doing the best they can with the knowledge they have. Virtually all the chemotherapies being used are still being researched. There's research not only on dosages but on how to combine them (with other chemotherapies as well as with non-chemotherapy approaches).
And no, the "targeted" therapies aren't "just as effective. In virtually all cases they are more effective WHEN COMBINED with chemotherapy.
This is not about pharmaceutical companies grasping money no matter how much gdp wants it to be about that. I'm sorry, but DUH -- you think people working to beat cancer don't know that there are risks as well as benefits? Do you realize how condescending you sound when you say that sort of thing???
OF COURSE each patient must decide on treatment with his or her oncologist. The first one I had wasn't open to discussion so I got a second opinion. That oncologist spotted a way to tweak my treatment but the first oncologist was generally spot-on. The problem with that first one wasn't information but "bedside manner." So I changed oncologist. This means I had three different opinions -- one from a D.O., one from an M.D. trained in the U.S., and one MD trained in Europe. They all were in virtual agreement.
I do not know why you think it is necessary to insult those of us who have dealt with cancer first-hand by suggesting that we don't know these treatments have risks as well as benefits, but it really is condescending.
But I will say this for those facing treatments like chemotherapy: with the new ways to deal with the side effect ... it was mostly a cake-walk. I only had a very small amount of mild nausea. Because these doctors gdp thinks don't know about side effects explained them so well and made sure I was prepared to deal with them (ex: anti-nausea medication) life just went on. It went on wearing a wig, but frankly I wish my real hair looked as good as that wig did! It was just not a big deal, and it was actually a powerful comfort to know that I did not have to rely solely on surgery.
I had three different kinds of chemotherapy, two combined and the other combined with Herceptin. I also take an AI. It is truly a great comfort to know that I have done everything I possibly can to make sure that cancer is well and truly gone.(I didn't have to have radiation because I chose a mastectomy instead of a lumpectomy, a personal choice).
I will continue to make these posts as long as gdp continues with his "sky is falling" posts about chemotherapy. I am extremely glad all those treatments were available, and I urge people to not "borrow trouble" and assume chemotherapy was awful. It's much easier than it was even five years ago, and THAT'S the truth. Then it's over and ... you're alive.

Since: Dec 05

Irvington, NJ

#9 Nov 30, 2008
LOL! Trying to discuss the nuances of cartography with those so wedded to the flat earth concept. As Mark Twain said, "the only problem with common sense is that it is not so common." Like Quackwatch fundamentalists and others, there are a certain number of "Allrightnicks" who have appointed themselves the arbiters of truth. You just aren't allowed to play in their sandbox.
Gail Perry

Spring Hill, FL

#10 Nov 30, 2008
No, gdp. That was an analogy *I* used, and not to put any person down (that's yur specialty) but to point out that anyone can find all the "proof" they want on line, including people who will argue that the Earth is flat. You must have taken that comment quite personally, however, since you keep bringing it up.

I have no idea who "Quackwatch fundamentalists" are, but I do know that you post information that is biased against oncologists. I can guess at the reason why, but tragic as it obviously was, it's also ten or more years old.

Oncologists aren't gods. They can only use the information currently available. My oncologist seems to be quite ahead of the curve on research and has guided me to choices that weren't widely apparent as the most informed choice until a year or more later, so I guess he's not one of those impulsive yahoos you keep complaining about.

I can only assume, since you keep whining because Quackwatch is on the planet, that you prefer some kind of alternative treatments. That would explain why you don't like oncologists, because the three I've known actually want EVIDENCE that something will work, and have some clue about the possible downsides.

You can play in this sandbox all you want, but if you spout misinformation and I'm aware of it, I'm going to call you on it. Frankly you have given enough biased advice (much of it anti-oncologist and anti-pharmaceuticals) that if I were asked, I would urge caution. You string catch-phrases together quite prettily, but you steadfastly refuse to document your claims in any verifiable way.

More than once you have cobbled together a viewpoint by over-interpreting what you've read (as best I can tell from your sketchy documentation). That, combined with misinformation, makes you a poor source.

Your response to these criticisms in the past has been name-calling. Go for it.

Since: Dec 05

Irvington, NJ

#11 Nov 30, 2008
In Japan, what is said, by custom, is taken literally and personally. The verbal exchange in the U.S. of "Hi, how are you? Fine, thanks, how about you? Fine, thanks." It is odd and inappropriate to them. In their opinion, this automatic exchange is so routinely overused among everyone, everywhere that it is shallow and completely devoid of any true meaning of concern for the parties involved in the exchange.

A similar, meaningless use of language is the constant, non-stop overkill sugarfest that is being found throughout the cancer messege board universe. Cancer patients need informed opinion good, bad or indifferent. I believe in "measured" moral support and consider it important. But the overkill sugarfest that is usually read is useless and sometime dangerous.

An oncologist (or anyone else) telling a cancer patient that chemotherapy is the only hope of survival, strikes total fear by telling them they would die in a short time without it. Fear is the greastest tool an oncologist has to snare a fearful victim.

There was a cartoon that showed a doctor with the initials AMA on his lapel, holding a syringe and standing next to a grave and a vulture with the initials FDA on it perched on the grave stone of a cancer patient that read, "Here lies Vic Tim, cured of cancer, died of side effects."
Gail Perry

Spring Hill, FL

#12 Nov 30, 2008
gdp, you don't know much about Japan. In fact Japan's social language is peppered with what we would call "niceties," and Japanese often try to do everything they can to avoid saying "No."

They may think our "How are you" exchange is odd, but we would find some of their introductory conventions odd also. Cultures vary.

Who claimed that any oncologist tells anyone that "chemotherapy is their only hope of survival?" In fact, unless you're in Stage IV the best chemotherapy can do is increase your odds. If you have reached Stage IV it *may* extend the amount of time you have left with your family.

I think the cartoon you described is far more of an extreme than what oncologists have to say about chemotherapy. Having heard about chemotherapy fairly recently from three different oncologists, all who were talking about *my* cancer, I know that what you say about oncologists is extreme. It is heavily biased and I have no idea why.

None of the oncologists used "fear," by the way. The most frank of them told me that I could reduce my risk of recurrence from about 40% without the two courses of chemo I had, the Herceptin and the AI's, and below 10% with them. No one EVER suggested that I "would die" without them. No one suggested I was guaranteed 0% risk of mets with them.

I have no ideea what you mean about a "non-stop sugarfest," but the FACT is that TODAY, chemo is often not terribly difficult because they have multiple solutions for the side effects. When people die from chemotherapy these are people who were in desperate straits to begin with in the GREAT majority of cases. A person is more likely to die in an auto accident than of chemotherapy.

That's not a "sugarfest." It's straight talk.

It just wasn't a big deal, folks. Chemo wasn't hard. The mastectomy was not difficult surgery. I never had any significant or lasting effects from Herceptin. I have had a lot of side effects from the AI's, but that's because they're doing what they're supposed to do. In the case of AI's, having side effects really is a sign that it's doing what it's supposed to do (that's not true of chemotherapy).

gdp, I think you should think about how very negative you are about these potentially life-saving strategies. I'm sorry your wife died, I truly am, but it's not the oncologists' fault that she got cancer. And, frankly, I don't believe for one second that she wasn't told about the potential down-side.

Since: Dec 05

Irvington, NJ

#13 Dec 16, 2008
The arrogance of some people gets rather obnoxious. Fortunately, most intelligent, receptive people are not so threatened by ideas which dare to challenge and question one-size-fits-all, widgets-on-an-assembly-line medicine. It's certainly not more comforting to see patient after patient succumb, not to the cancer, but to an early demise thanks to wrong-therapy/wrong-dose cookie-cutter treatment. Ignorance is not bliss.
Gail Perry

Spring Hill, FL

#14 Dec 16, 2008
Please provide statistics that compare the number who survive vs. the numbers who "succomb" to chemotherapy. Please document how you know they were either on the wrong therapy or the wrong dose. Please document how you know they received cookie-cutter treatment.

Or look arrogant.
Billy
#15 Sep 23, 2013
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