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).

Social Media's OK Corral: Docs vs. Patients

The O.K. Corral was a site in Tombstone, Arizona Territory where a gunfight took place on October 26, 1881. In that fight, the Earp brothers and "Doc" Holliday killed some cowboys who refused to disarm.

I mention this as a analogy to what I foresee happening in the health social media realm where the conversation is not as friendly or beneficial as some pharma social media pundits would have us believe. If pharma marketers are not careful, they may find themselves in the middle of the crossfire.

I am talking about the crossfire between physicians and patients, especially with regard as to which "stakeholder" group will be more credible as hired "opinion leaders."

You probably already know all about physician KOLs ("key opinion leaders") and how pharma hires KOLs to influence doctors. I predict that in order to be effective in social media that are inhabited by patients, pharma will hire respected patients to follow the discussion and to point their followers to "key" information, which includes key Rx-related information or information that supports the benefits of Rx products (see "Some Social Media Patient Opinion Leaders Want to be Paid Pharma Professionals" and "PHARMA Co Patient Opinion Leader Programs").

This will lead to the inevitable conflict with physicians who may have different ideas as to what "key" patient information should be.

At two recent industry conferences, I witnessed what I think is the opening salvo between the two opposing camps. First, at a multi-channel pharma marketing conference that I chaired in Princeton, NJ, a physical wall was erected between a physician panel on one side of the room and a patient panel on the other side. Both were supposed to talk about what they wanted from the pharmaceutical industry. As I reported, the patients essentially wanted money and were quite forthright about it. The physicians, on the other hand, were too sophisticated to ask for money directly -- they already are getting plenty of money from pharma. They asked for technology or rather free technology such as iPhone apps.

But the conversation that hinted at the coming Social Media OK Corral Docs vs Patients struggle occurred during a patient panel at the Digital Pharma East conference (ie, "A Panel of ePatients Discuss Key Issues that Affect their Lives, Relationships and Treatment").

Part of the discussion revolved around how the "value proposition" of patient online communities was the vast amount of information available from patients that is "more accurate" than information that patients typically get from healthcare providers/physicians. That, in itself, is not surprising or dangerous. But another statement made by a patient panel member sets the stage for the coming gunfight. That statement concerned patient evaluation of specific brands. The patient said that her physician was of the opinion that all branded Rx drugs for treating her condition were essentially the same. She begged to differ and pushed for her favorite brand.

It seems that patients are more in tune with pharma's direct-to-consumer (DTC) advertising premise: one brand of insulin or ACE inhibitor is better than another brand. Usually, it's the advertised brand that's better than a competitor brand or the unadvertised generic brand.

Since Rx DTC advertising has ingrained the belief in consumers and patients that one brand of Rx is better than another, it benefits pharma marketers to use online patient opinion leaders such as those on the above-mentioned panel to influence other patients online. Once they do that, marketers are again placing themselves in the middle of the patient and his or her physician just as they have been accused of doing with mass media DTC advertising.

There is a wall between physicians and patients not only at industry conferences, but also within online communities. Patients have their communities and physicians have theirs. Unless the two stakeholders can meet online and have a dialogue, someday there will be a gunfight. Pharma marketers will continue to arm both sides. Maybe they'll get caught in the crossfire, maybe not. Time will tell.

Pharmaguy's Comedy Improv(e) Club -- An New Idea for "Unconference" Entertainment

The pharmaceutical industry is neither funny nor improvisational, yet those two attributes are precisely what I have depended upon to make Pharma Marketing Blog entertaining as well as informative.

But there are quite a few "funny" people currently or previously associated with the pharmaceutical industry. Kevin Nalts (aka Kevin Nalty), for example, is a former Merck Marketing Director and now makes a living -- I hope -- as a self-proclaimed YouTube comedian (see "Enlightened Stupid Marketer"). I also believe that my Twitter pal Lawrence Sherman (@meducate) dabbles in  the comedic arts.

At ExL's Digital Pharma East I learned that Jason Youner, ExL Conference Director, does standup comedy on the side at a comedy club in Jersey City, NJ (ie, Stockinette Café at 581 Jersey Ave; the 2nd Friday of every month; Jason not only performs, he hosts and produces the show). He was quite funny roasting me during his introduction to my Pharmaguy Social Media Pioneer Award "unceremony" (see "First Pharmaguy Social Media Pioneer Award Given to Janssen's Alex Butler"). At the Pixels & Pills cocktail party, DJ Edgerton (@wiltonbound), CEO of Zemoga, revealed his humorous side by suggesting various kinds of undershirts I should wear when I gave the Hawaiian shirt off my back to Alex Butler.

Perhaps a few of us "comedians" should get together and form the "Pharmaguy Comedy Improv^(e) Club" and volunteer to perform at industry conferences. I am sure it will liven these up considerably. As always, I appreciate your feedback, especially if you wish to join the troupe. Send your email to pharmaguy@epharmapioneers.com

PHARMA Co Patient Opinion Leader Programs

[Below is a blog post that someday SOON may appear on a PHARMA Co Blog such as AZ Health Connections, which recently posted a notice about "AstraZeneca And Doctor Speakers Programs" (read it here). I substituted "patient" for "physician" in the following post to illustrate a point.

In this new social media era, where there is much discussion about pharma participating in patient discussions online, there is a possibility that pharma will hire influential online patients to act as "opinion leaders" just as they have hired physicians to be key opinion leaders (KOLs). Patients have already been hired by pharma companies and their agents to troll patient sites for comments made by patients online (see, for example, "Did J&J Troll Social Media Sites to Ensure Its Motrin "Recall" was a Secret?")].

Beginning soon, news organizations will be publishing a series of stories examining the financial relationships between patients and the pharmaceutical industry. Their focus will be on payments made to patients who serve as “social media moderators” or "opinion leaders" on behalf of companies and their medicines.

PHARMA Co would like to provide our perspective on the issue by having Marie M. – PHARMA Co’s US compliance officer – answer the key questions we’ll be asked by reporters in coming years.

Why does PHARMA Co engage with patients as moderators/opinion leaders?
Marie: PHARMA Co works with online patient opinion leaders (POLs) or moderators to provide other patients online with accurate and balanced information about the use, safety, benefits and risks of our medicines. POLs have the expertise and credibility necessary to educate colleagues to ensure they have the information they need to make informed treatment decisions.

Patients ultimately benefit when they are well informed and knowledgeable about our medicines, treatment options and standards of care.

Why does PHARMA Co pay patients to participate?
Marie: It is appropriate to compensate POLs for the time they dedicate to providing information to other patients about our medicines and who act as moderators of our online discussion boards. Patients who tweet or post information online about our medicines are compensated at a fair market value based on their qualifications and the amount of time they dedicate to the task. We never pay patients in exchange as an incentive to promote our products.

There currently is NO cap on how much each POL can receive from PHARMA Co each year.

How does PHARMA Co ensure laws and industry policies are followed?
Marie: Before a POL can tweet or post information on our behalf online, they must participate in extensive training on our medicines, policies, and the laws and regulations that apply to industry-sponsored presentations. Actually, however, there are NO laws and regulations that apply to industry-sponsored tweets and posts made by patients online. But, be assured, our policies prevent the company from paying POLs in exchange for asking their physicians to prescribe our medicines or as an incentive to promote our products.

How does PHARMA Co select patient opinion leaders?
Marie: There are several criteria that PHARMA Co evaluates when a patient is nominated to be a tweeter or online poster on behalf of the company, including positions within leading online patient social networks, national patient advocacy organizations; membership in special patient opinion leader networks such as WEGO; consistent tweeting and posting records; participation in research trials; and regularly tweets or posts information online.

First Pharmaguy Social Media Pioneer Award Given to Janssen's Alex Butler

I have finally gotten rid of that seriously yellow Hawaiian shirt that has symbolized the Pharmaguy Social Media Pioneer Award and my involvement with pharma's slow march into social media over the past year.  

Alex Butler (see http://bit.ly/AlexButler), Digital Strategy and Social Media Manager at Janssen UK, graciously received the "shirt off my back" at lunch yesterday during the 4th Annual Digital Pharma East conference. That's Alex, the shirt, and my disrobed self pictured on the left. Thanks to Steve Woodruff (@swoodruff) for the photo documenting this historic event.

Kudos for Alex came immediately via Twitter:

@DigitalPharma: Congrats to @Alex__Butler, winner of @pharmaguy's first ever Social Media Pioneer Award! Hope yellow's your color. #digpharm

@pixelandpills: Aaaand the shirt comes off...congrats to @Alex_Butler for his @pharmaguy Digital Pioneer Award win. We think you should frame it. #digpharm

@skoko: Well deserved! Congrats! @Alex__Butler, winner of @pharmaguy's Social Media Pioneer Award /Wish I had seen that shirt come off ;-) #digpharm

@GaryMonk: Well done mate! RT@Alex__Butler: Thnx to @pharmaguy for giving me the famous shirt 2 look after for 1 yr re: social media pioneer award....

@newstream: Congrats! @Alex__Butler, winner of @pharmaguy's Social Media Pioneer Award /Wish I had seen that shirt come off ;-) #digpharm”

As I mentioned in this Pixel & Pills video interview by the lovely Sarah Mclellanny (@sarahmclellanny), I based my choice partially on input from respondents to an online survey. About 65 people participated and the results are shown in the following chart. Each respondent was able to vote for more than one candidate; see the list of ALL the 2010 Pharmaguy Social Media Award candidates here (pdf).

NOTE: ALL candidates will receive the coveted Pharmaguy Social Media Pioneer Lapel Pin (shown on the left).

Aside form the votes and comments that I received via the survey, I also was very much impressed with a presentation Alex made in September at the DigiPharm conference in London. He talked about the launch of Janssen UK's Psoriasis 360 Facebook page (see "Markets as Conversations: Can You Have a Discussion with 'Psoriasis 360' on Facebook?").

When I handed over the Hawaiian shirt to Alex, I stated that another important factor in my decision was that Psoriasis 360 is the first consumer-oriented pharma FaceBook page to allow comments without pre-moderation. All comments are posted first and then reviewed afterward. So far, only a few comments had to be removed -- mostly because of vulgar language or mentions of product names. If a comment includes a product  name, the moderator(s) ask that the comment be resubmitted with the product name removed.

Psoriasis 360, however, may NOT be the FIRST pharma Facebook page that allowed unmoderated comments to be posted. Sanofi-Aventis' VOICES Facebook was probably the first, but only unintentionally! Listen to that story and its aftermath here: "What Sanofi-Aventis Learned from Its FaceBook Experience & What the Experts Recommend It Do Now".

Also, after I made my presentation, Joan Mikardos, Senior Director, Business Innovation, Sanofi-Aventis, reminded me that another S-A Facebook page -- "THE COALITION TO PREVENT DEEP-VEIN THROMBOSIS (DVT)" -- which was launched BEFORE Psoriasis 360, also allows unmoderated posts.

Actually, the DVT Facebook page is technically owned by "The Coalition to Prevent Deep-Vein Thrombosis (DVT)," which is "funded by sanofi-aventis U.S. LLC," as revealed on the Coalition's .org site (see http://www.preventdvt.org/). The "about" page of the site states "In February 2003, more than 60 organizations assembled at the Public Health Leadership Conference on Deep-Vein Thrombosis (DVT) in Washington, D.C. to discuss the urgent need to make DVT a major U.S. public health priority."

Technically, therefore, the DVT Facebook page is not a true S-A site, unless the Coalition is just a front for S-A and not a coalition at all.

Whatever the true provenance of the DVT Facebook page -- a topic I may blog about at some other time -- my award was not a contest to determine who did what first. It is more about people such as S-A's Dennis Urbaniak, who is a bona fide social media pioneer and who received recognition as such in my award "unceremony."

Pay It Forward!
What will happen now? Will another pharma social media pioneer receive another Hawaiian shirt next year?

There WILL be another award, but NOT another shirt. As Alex said in his Pixels & Pills interview, he is now the custodian of the Hawaiian shirt, which he will pass on to the next deserving pioneer a year from now. Just like the Masters green jacket! Meanwhile, keep those nominations coming by taking my survey here.

Proper Care and Handling of the Shirt
Alex and any future Pharmaguy Social Media Pioneer custodians of the Hawaiian shirt award have an obligation to maintain the shirt in its original condition. Here are a few proper care suggestions:

1. Wear the shirt with pride on special occasions such as when attending industry conferences, in-house meetings with your managers, etc. However, avoid wearing the shirt to dinner parties or sporting events where it may suffer irreparable staining or ripping!
2. Do NOT machine wash the shirt! Dry cleaning is recommended.
3. You may mount the shirt for display on your office wall, but do not use any mounting technique that will permanently harm the shirt. To protect it while on display, it is best to frame it behind UV-protective glass.
4. Do NOT allow anyone else to wear the shirt! Not even your significant other who you may wish to appear more sexy "when the time is right."

Some Social Media Patient Opinion Leaders Want to be Paid Pharma Professionals

Last week at the Multi Channel Pharma Marketing Event, where I was interviewed by Pixels & Pills' Sarah McLellan ("John Mack Goes Back to His PharmaGuy Roots!"), I heard a lot about "patient self-advocacy." Lately, this term -- aka, patient empowerment -- has come to mean more than a desire by patients for more information and involvement in the health care process. It's also being used to describe a few "Health Activists" like Allison Blass (Patient Blogger, Diabetes Activist, Lemonade Life) and Megan Oltman (Certified Migraine Coach, Patient Blogger, FreeMyBrain). Allison and Megan participated in a panel discussion entitled "Understanding the Needs of Today's Empowered Consumer," which was led by Jack Barrette, CEO, WEGO Health.

Barrette has been taking health activists -- or "Consumer Opinion Leaders" (COLs) as he likes to call them -- to pharma companies for private discussions similar to this panel discussion in which I participated. Allison seems particularly busy making the rounds among pharma companies and pharma conferences (see her review: "Health Activism").

Jack, Allison, and Megan emphasized that online patients are looking for conversations with real people from pharma companies, not brands. This is a point I have often made (see, for example, "Markets as Conversations: Can You Have a Discussion with "Psoriasis 360" on Facebook?"). This desire was opposed to what physician panelists were requesting in a simultaneous panel being held behind the sound wall that separated the two camps. The physicians desired technology and apps to be supplied by pharma.

Allison told the audience about attending a "Diabetes Social Media Summit" sponsored by Roche in Orlando, Florida. Allison came away from that Summit feeling much closer to Roche and now has a more personal relationship with "Todd," one of the Roche Summit organizers who was communicating with Allison before the event. "Oh my God," said Allison at the Summit, "I'm finally getting to meet you!"

The physicians' ears next door were probably burning with envy. They probably miss the good old days when pharma companies could invite THEM to outings at resort locations. But that's now verboten by PhRMA! There are no PhRMA guidelines, however, about paying "patient self advocates" to attend "summits" at resort locations. Not that's there's anything wrong with that! I'm just wondering if "COLs" are the new "KOLs" (ie, physician Key Opinion Leaders) and where this will all lead. In fact, I know where it may all lead: to Senator Grassley, who may be writing letters to pharma CEOs requesting information about such "summits."

Near the end of the patient panel discussion, Jack asked Allison and Megan to tell the audience what they want from pharmaceutical companies. "You need to pay some one's full time salary," said Allison referring to the desire of some pharma companies to interact with patients in online communities. "The only way to sustain growth and involvement in a [online] community," said Allison, "is to have someone who actually does it [manage social media interactions with patients] as their job... to become the person who is known and loved by the community."

I think Allison was talking about an online patient community set up and run by a pharmaceutical company as opposed to an independent online patient community that already exists. Pharma companies should just give bundles of money to the latter.

It makes perfect sense that pharma should have full-time employees managing their social media initiatives. However, it becomes problematic when pharma companies hire patient advocates to monitor other communities (see, for example, "Did J&J Troll Social Media Sites to Ensure Its Motrin "Recall" was a Secret?") or to represent them in online communities.

The main issue is "transparency," which may be a new concept for eager patient advocates who wish to be hired as pharma COLs. It's a question I asked Allison when she mentioned receiving glucose meters and other goodies from pharma companies hoping she would endorse them. Allison is familiar with FTC guidelines regarding that issue, but I wondered how many other patient bloggers are.

Should Pharma Hire Online "Patient Opinion Leaders"? Take my survey: http://tinyurl.com/2fr784u

Pre-Emptive Medication Adherence. Is Pre-Emptive DTC Next?

Computers are intruding into our lives more and more these days. I'm not talking necessarily about the Internet, but about automated programs that different industries use to do things like initiate stock market trades without human intervention, which is a story I saw last night on 60 Minutes. It's reputed that one such trade sent the market in a momentary tailspin that could have lead to a monetary crisis. According experts, such automated trades are undermining the general public's trust in the stock market. I for one have taken a lot of my retirement money out of stocks.

Today I read about how Express Scripts, a pharmacy benefit management (PBM) company, is now able to accurately predict up to a year in advance which patients are most at risk of falling off their physician-prescribed drug therapy -- and to intervene in customized ways to improve those patients' adherence. To do this, Express Scripts uses "a set of proprietary computer models" that analyzes personal data of patients in its database. The data includes such things as prescription history, whether the patient has kids living at home, etc.

"Previous industry attempts to predict therapy adherence were hampered by both the types and quantity of data available," said David Tomala, director of advanced analytics at Express Scripts. "Our tens of millions of members, hundreds of millions of annual prescriptions, and advanced understanding of human behavior were key to 'cracking the code' on therapy adherence. We are now the first pharmacy benefit manager to be able to -- with high fidelity -- discriminate in advance and intervene in an effective manner. This approach addresses adherence problems among those patients who need our help the most. Improved adherence is the hallmark of better quality care, healthier patients, and reduced overall medical costs" (see press release).

Of course, it is nothing new for PBMs to mine their patient data and find those patients who have not filled prescriptions.  According to the Wall Street Journal, "the new efforts are broader, and can focus on apparently healthy people. They use models developed from enormous troves of medical and other data. These are then applied to each patient's own claims information."

PBMs often get paid by pharmaceutical companies to identify patients who are not refilling their prescriptions and to send them prescription refill reminders by mail or call them. Increasing adherence can greatly help pharmaceutical bottom lines and PBMs also benefit when more prescriptions are filled. Conventional wisdom -- and maybe even some research data -- suggests that patients will also benefit.

But computer models often result in unintended consequences as evidenced by automated stock market trades. What could be the equivalent breakdown in the health market? Obviously, there's the privacy issue: "Ethics researchers say such efforts can raise privacy and other concerns if people don't deliberately grant permission for such use of their data, as well as potentially usurp the role of doctors, who know patients best," notes the Wall Street Journal.

"It undermines the trust an individual has in their physician," said Mark A. Rothstein, a bioethics professor at the University of Louisville," who was quoted in the WSJ article.

It could also undermine the trust in the pharmaceutical industry, I suppose.

One further thought. If these computer programs can identify future health problems in otherwise healthy people, will there be pre-emptive pharma-sponsored notices sent out to patients advising them to see their doctors? As consumers provide more and more private information to pharmaceutical companies, I can even imagine pre-emptive direct-to-consumer advertising!