Tuesday, October 26, 2010

A Breast Cancer Patient's Painful, Difficult Therapy Choice: Generic vs. Brand?

Since this is national Breast Cancer Month and I am forced to watch NFL linebackers wear pink shoes and mouth guards, I thought it would be appropriate to discuss an issue that just came up in comments to my post about Sanofi-Aventis, Taxotere, and the disgruntled patient (see "Should Sanofi-Aventis Submit an Adverse Event Report Based on 'Disgruntled Patient's' Comments to VOICES FB Page?" and comments).

An anonymous comment to that blog post opened my eyes about issues facing breast cancer patients beyond what I believe many proponents of the "pink" promotional campaign envisioned. Here's the comment:
"It's not just one disgruntled cancer survivor. There are over a hundred of us. Of course, there's no promise that our hair would grow back. GENERALLY grows back. Well for those of us who battled breast cancer but are forced to look at our bald selves in the mirror every day, "generally" isn't good enough. Yes, we're alive. I'm grateful for that. But again, no promise of how long...and with small children, that's another painful reminder of what I've been through. The thing about S-A and Taxotere is this: there's another drug, Taxol, which doesn't cause this permanent alopecia we're dealing with. But we were never told that there was a choice. And what do you think I would have chosen if I'd had a choice? I'm in my early 40s so dealing with permanent alopecial is especially difficult. I have a job in a senior management position. Hard to earn respect when I look like Ben Franklin. We're not mad that Taxotere caused us to experience permanent alopecia...we're mad that we weren't given the choice of the more hair-friendly medication. And why is that? Our oncologists didn't even know. Don't you think they should be made aware of this fact?"
To which I responded:
"While I am not knowledgeable regarding the benefits vs risks of one treatment vs another, shame on your oncologist for not knowing or caring enough to offer you a choice!"
This gave me an idea of how important hair loss can be to breast cancer patients, something that other commenters to my blog post dismissed by saying things like "you should be happy you are alive," etc. Do many pharmaceutical marketers realize this? My friend Rich Meyer thinks not. "Pharma’s priority is still spreadsheets not patients," says Rich (here). "Patients are leaving pharma marketers behind and pharma marketers act like they still matter."

But is Taxol really better than Taxotere with regard to hair loss? To answer this question, I used Google to search on "taxol vs taxotere" and found some interesting online forums and discussions devoted to the issue. Here's a representative post by "billsgirl" that I found on the community.breastcancer.org/ site:
"I have one more A/C tx 2/22, and have done really well with little se to complain about. Now I must decide which Taxane I should go with. I'm leaning toward taxotere because my onc agrees that the bone marrow issues would be easier for my body to tolerate given my positive experience with the A/C, rather than risk neuropathy.

"Also, what about the hair? I've read some who said their hair started growing back after A/C and through T. I've read some scary stories about permanent hair loss. I'd hate that - I mourned my heai more than my breasts (I know that's odd...)

"I'd love your comments. Anything to help me make my decision."
What "help" did "billsgirl" get? There were several somewhat helpful comments and encouraging posts in this forum, but none really answered the question about which drug is best.

On www.medhelp.org -- a Cleveland Clinic "partner" -- I found a similar question by a patient ("Pam") and an "answer" from a physician.
"This forum is just fantastic!! Thank you Cleveland Clinic and Med Help Int'l. for giving people like me a reliable place to ask questions!!!

"My question is: Can you tell me the difference (if any) between Taxol and Taxotere? Does one work better than the other for particular types of breast cancer? My doctor suggested Taxotere, but didn't really give me a good explanation as to why. Your thoughts will be most appreciated."
Doctor's Answer:
"Dear Pam, Thank you for your complimentary comments regarding this Forum.

"Taxol (paclitaxel) and Taxotere (docetaxel) are both from the same family of medications - the taxanes. Both of these show a high level of activity when used as single agents in metastatic breast cancer.
"In reviews of reported studies, when compared with standard therapies Taxotere looks to be the most active single agent in treatment of metastatic breast cancer.

"There are some differences in the treatment schedules of the 2 medications, and there are some differences in the side effects of these 2 medications. I have listed the side effects of both medications.

"Taxotere: decrease of white blood cells, red blood cells and platelets, flu-like symptoms, fluid retention, numbness and/or tingling to fingers and toes, muscle aches or bone pain for a few days after each treatment, mouth sores, hair loss, decreased appetite.

"Uncommon Side Effects: allergic-type reaction, blood pressure and heart rate changes, nausea and vomiting, diarrhea, skin rash usually occurs on hands and feet, nail changes, menstrual cycle may become irregular or stop permanently, menopausal effects including hot flashes and vaginal dryness. Decreased desire for sex during treatment.

"Taxol: decrease of white blood cells, red blood cells and platelets, allergic-like reaction, blood pressure or heart rate changes during the infusion of the medication, mouth ulcers, numbness and/or tingling to fingers and toes, muscle aches or bone pain for a few days after each treatment, mouth sores, hair loss, diarrhea.

"Uncommon Side Effects: nausea and vomiting, nail changes, menstrual cycle may become irregular or stop permanently, menopausal effects including hot flashes and vaginal dryness. Decreased desire for sex during treatment."
Hair loss is mentioned (buried) as one side effect for both drugs.

So, I am still not sure that Anonymous was correct in her assertion that Taxol does not cause hair loss. But it's clear that her oncologist didn't offer her the kind of comparison that was offered to "Pam" online. Could it be that her oncologist had a conflict of interest? I suggested that in my response to Anonymous:
"It's my understanding that oncologists often make a profit 'reselling' these drugs. Obviously, in that case, they have a vested interest in offering patients the drug that gives them the highest profit. I do not know if Taxotere and Taxol differ in this respect."
What I DO know is this: Taxol is a generic medication and Taxotere is a brand medication. And back in 2007, Sanofi-Aventis, which manufactures and markets Taxotere, received a letter from the FDA warning the company not to make superiority claims for Taxotere vs. Taxol (see here).

4 comments:

  1. Anonymous1:54 PM

    I recently had the opportunity to get both drugs, taxol and taxotere. I was being treated for ovarian cancer and I was first given taxol--three cycles. I lost all of my hair after the second cycle and had blood pressure and pulse problems with Taxol (BP 48/30, P 130).
    So, they put me on Taxotere for three cycles and I had no adverse reactions. It has been six months since my last treatment and my scalp hair has grown back (slow but thick) but my eyebrows are still very light (they were dense before treatment).

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  2. Dear anonymous,

    Thanks for your comment. It appears that the lesson here is that side effects as well as efficacy of drugs depend upon the patient as each patient may have completely different experiences. Unfortunately, unless we know why there are these differences from one patient to another, your anecdotal experience is of limited benefit to other women who are faced with the same decision.

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  3. Anonymous5:50 AM

    The point really is to give women the choice. To make their own risk assesment.To inform them that there is a 1 in 16 possibilty that their hair might not return EVER. Then they can choose to take the chance or not. Its all about the patients rights to fully understand the treatment being offered and to choose.
    That's the choice that is being denied to hundreds of women everyday all because SA think they have the right to keep this adverse side effect hushed up. They know that women do not want to be left permantly bald when they could choose another drug thats not produced by them.

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  4. Cancer patients will undergo a lot of emotional and physical stress and should therefore be supported by family members and friends.

    ReplyDelete