Broadening ALS Research to Help Patients III: Make Biogen Idec Walk Its Talk

Posted on July 28, 2012 by bbzinger

Like many readers of this blog, I have been exchanging emails with Dr. George Scangos, CEO of Biogen Idec, the company running the clinical trial in which I am a participant. The trial is testing the efficacy of a drug called “dex” for short. (Thanks so much to all of you who wrote to him for your support.)

The upshot of our “conversation” is that company will not allow me to remain in the trial if

Because of a drug company, this is where I’m living

get a diaphragm pacer before the trial ends sometime in September. If I do so, they will exclude me from eligibility for dex if and when it becomes open label.

In the interest of transparency, my email exchange with Dr. Scangos is copied here. I have a few observations, and a new call to action for those who care about these issues.

EMPOWER?

The dex trial being run by Biogen Idec is called EMPOWER (in all caps, no less). Given how the company is interpreting the rules of this trial, I think there is little doubt that only the company and its shareholders will be empowered if this trial is a success. The power of ALS patients, including those who, like me, have given more than a year of time and effort (and considerable amount of bodily fluids) to the trial, seems to be way down the list.

My Crap Shoot

It’s possible that this trial will be a failure, in which case my concerns about access to dex if I’m forced out of the trial will be moot.

If the trial is positive, I may be in trouble, or I may not be. If I’m currently on placebo, the drug might help me. That’s trouble if I have to wait to get it.

If I’m currently on the drug, I may have gotten all the benefit possible from it already, in which case my being booted out of the trial won’t matter. It’s also possible, that, if I’m currently taking the drug, stopping it has adverse effects. Again, that’s trouble.

In the midst of this dilemma, I have to make some decisions about what is best for my health. Against these various outcomes, do I get a diaphragm pacer now in hopes that will provide me more benefit than the drug might if proves effective, or do I wait until the trial becomes open label — maybe an extra two months — so I can be eligible to the obtain the drug on open label if the trial is a success? If I do the latter, at what cost to my health from delaying the pacer?

The bigger question is why any patient with ALS should be faced with this kind of dilemma. Biogen Idec has the power to remove this question from the debate, but it refuses to do so.

What Biogen Says versus What It Does

As you will see from the emails below and others in previous posts on this topic, Biogen Idec says it is committed to finding effective treatments for ALS and getting them quickly into the hands of patients.

Biogen Idec, through its CEO, also says this: “It is an ethical consideration to allow patients who have participated in the trial to benefit from the drug, should it prove to be efficacious.”

And this: “If you decide to have the pacemaker and come off the trial, the data from your participation will be counted up until the time that you leave the trial. You still will have contributed to the trial and to the development of what we hope will be an important therapy for ALS patients.”

So here’s the deal Biogen Idec is “giving” me and patients like me: if we are booted out of the trial by seeking other treatments, the data from our participation (in my case, at least 14 months of data for a trial where minimum participation is 12 months) will be analyzed as part of the evaluation of drug efficacy. If the drug proves to be effective, however, we will not automatically receive it, we will have to plead for it. Others who decide to remain hostage to these trial rules will be automatically given it as part of trial design.

In other words, Biogen Idec will receive all the benefit it possibly can from our participation, but our benefit, if any, will be limited to the effects we may have received from the drug — if we were on it  — while we were included in the trial.

Time to Make Drug Trials Work for Patients

The FDA has a role in setting drug trial rules. Biogen Idec claims to be hampered in part by those rules. While I continue to believe that the company in this case is unnecessarily using these rules to the disadvantage of patients like me, they are not budging.

So it’s time to go to the FDA to demand change. If you agree that these trial rules, as interpreted, are unfair to ALS patients, let the FDA know it. Tell the FDA to make Biogen Idec do the right thing.

And suggest to the FDA that they require drug companies in large ALS trials to have an independent ombudsman to address patient concerns. The CEO of a company cares about the company; patients needs are secondary.

>The Director of the office of the Center for Drug Evaluation and Research is Dr. Janet Woodcock. Her email address is Janet.Woodcock@fda.hhs.gov

> The FDA Commissioner is Margaret Hamburg. Her email address is margaret.hamburg@fda.hhs.gov.

> Please send a copy of your message to the FDA to Dr. George Scangos at Biogen. His email address is: george.Scangos@biogenidec.com.

> And please send a copy of your message to the FDA to my neurologist, Dr. Jonathan Katz. His email address is katzjs@sutterhealth.org.

Please copy anything you send as comment to this post. And thanks for caring what happens to people.

©  Barbara A. Brenner 2012

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Email exchange July 23, 2012

Dear Dr. Scangos,

Thanks for your message. See my reply below [in italics] in the interest of what I hope will be clear communications.

Barbara

Dear Ms. Brenner,

We would love to honor your request, but I am very sorry to say that we can not do so. The reasons are complicated, and perhaps Doug and I have not been clear in our explanations why, so I’m going to give it one more try.

1.  The trial protocol does not mandate that each patient stay on the trial for one year. The trial protocol requires that all patients stay on the trial until the last patient completes one year of treatment.  It is designed that way so that most patients will be on study for more than one year to satisfy the views of the regulatory agencies here and in Europe.  We can not change those rules in the middle of the trial.

BB: When you say “so that most patients will be on study for more than one year,” I cannot  believe the regulatory agencies where vague what constitutes “most patients.” Can you share that information with me (and those copied on this message), as well as  the number of patients  that have been one the study for more than a year and  for how long; and the total number of patients  in the study?

2.  The subgroup analyses that you suggest are not feasible for a range of statistical, medical, and regulatory reasons.

BB: I would like an explanation  of these reasons. But I think  it requires knowing  the information about the number of patients in the trial and how many have been  in the trial for more than a year, and for how long.

3.  The trial protocol does not allow the type of treatment that you are seeking.

BB: The  treatment I am seeking was not,  if my memory serves,  approved by the FDA when this trial  started. If I’m correct about this, it’s not that protocol  excludes the treatment; it  wasn’t considered one  way or another. And  why are you allowing  this treatment  on the open label phase of the study but not for patients  who have been  on the study more than a year.

4.  Exceptions to these rules jeopardize the power of the trial and thus the availability of Dexpramipexole to all patients with ALS if it is indeed shown to provide an acceptable risk/benefit profile.

Please believe me that we have no reason to want to deny your request.  We have devoted ourselves to trying to help patients with ALS and other neurodegenerative diseases and would love to grant your request and help you.  I have tried to respond personally to your email  and to the emails of your supporters rather than sending a rote response because of the obvious sincerity and depth of the requests.  However, I don’t want to stretch this issue out.  As heart-wrenching and difficult as it is, we must stand by our decision in the interest of all patients with ALS.

On a personal note, I want to you to know that my thoughts and prayers are with you.  We obviously don’t know each other, but you must be an extraordinary person to have such a large collection of people who care so deeply about you.  And just so you know, the reply I sent to your supporters was not canned, as you state on your blog.  I wrote it myself on Saturday trying to explain the reasoning for our decision.  I’m sorry if it appeared canned, but I was just trying to get the same information to all of the people who wrote.

BB: Thank you  for your thoughts  and prayers. What  I need is more thought by people like you as  to how to best meet the needs of ALS patients for whom time  is so short. 

I’m sorry for offending  you  by saying your response was canned. I’m should  have said “identical.”

********************************

Message sent July 24, 2012

Dear Dr. Scangos,

In thinking more about our exchange, I wonder if you perceive as I do that my situation, like the dex trial in general, has the capacity to provide information that will benefit all ALS patients? If others, like  me, spend many months in the trial, and then go one to take advantage of another therapy, what might that tell us about mutiple treatment modalities and their effectiveness? Since, in most health settings, this is how treatment works, I suspect and hope that, as more treatments become available for ALS, we will get more information like this of value of patients. Why not start here?

I was also wondering whether, if I’m forced out of the trial before the open label period by a decision to get a pacer, will the data the company has collected from my participation nonetheless be evaluated in the trial results?

Thank you.

Barbara

*********************************************************************************************

Reply received July 24, 2012

Hello Barbara,

You are right in saying that in most health settings, at least in the US, patients and physicians take advantage of multiple modes of treatment to maximize the benefit they receive.  There are many things about our health care system that can be improved, but that flexibility is one of the good aspects of our system.  In a clinical trial, the situation is different, of course.  The purpose of the trial is to determine if a particular treatment, in this case Dexpramipexole, is safe and provides a benefit to patients.  For that reason, the effect of the tested treatment has to be isolated from other treatments that affect outcome. The reason that you want the pacemaker is that there is a good chance that it will improve your breathing and make you feel and function better.  That potential improvement as a result of the pacemaker can mask the impact that Dex has.  If you are on the drug arm, it can make the drug look artificially good, and if you are on placebo, it can make the drug look less good than it actually is.  What we are trying to accomplish is a clear outcome that will accurately determine the safety and effectiveness of Dex, so that if it is positive, we can get it to the maximum number of patients in the shortest possible time.

If you decide to have the pacemaker and come off the trial, the data from your participation will be counted up until the time that you leave the trial.  You still will have contributed to the trial and to the development of what we hope will be an important therapy for ALS patients.

There is something else that you should know.  We obviously don’t know at this point if Dexpramipexole is working or not, but we will know later this year.  In the case where it does turn out to be positive, we want to be able to make it available to some ALS patients even before it is approved by the FDA.  We are making enough of the drug to be able to do so, and we are having discussions with the FDA about how to ethically and legally conduct such a program.  Although our plans are not yet finalized, we probably will seek to make the drug available through centers that participated in the clinical trial.  Since you are obviously being treated at one of those centers, should you come off the trial, the drug may still be available to you through that program.  My best guess is that the program will be available early next year.  Of course if the outcome of the trial is not positive, then this is all moot.

I talked today with the head of the Massachusetts Chapter of the ALS Association and with an ALS patient here in Boston.  We had them in to talk with our employees at lunchtime as part of our ongoing program to make sure that all of our employees understand what is at stake.  I hope that for their sake, for yours, and for all patients with ALS that our trial is successful and that we are able to offer at least some relief to patients.

Sincerely,

George Scangos

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My reply to the above message, July 24

Hello, George,

Thanks  for this.

I understand  the difference between general health settings and clinical trials.

I appreciate that if I get a pacer and am forced out of trial, you will still count the data received from me up until that point and that you recognize that my participation will have contributed to the knowledge about the effectiveness of dex.

What I’m still puzzled by is the timing issue and why it makes so much difference. If I get the pacer in the next month, before the September trial cut off, that means you will have one  less month of data for me for the trial because you don’t want to run  the risk that, in month’s time, the pacer could mask the benefits of the drug. But, after September, when I assume you will continue to follow patients after the drug goes to open label, you’re not concerned about that masking effect because you will allow patients in the trial to then have pacers. Why does it matter in August, but not September?

You have addressed a lot of my concerns here. I now understand that your goal is to make the drug, if it shows benefit, available to centers that participated in the trial, including Forbes Norris, hopefully by early next year. If I were to remain the trial, would I have access to the drug sooner?

Thank you.

******************************************************************

Scagnos message July 25, 2012

Hello Barbara,

The September date is important from a regulatory standpoint.  The trial officially ends one year after the last patient was enrolled, which as you know is in September.  At that point, the data are “locked” and analyzed, and will comprise the package submitted to the FDA and European authorities for approval.  Patients on the trial will then all be switched to drug.  Patients will continue to be followed to gather longer-term data on safety and efficacy, but although the data gathered beyond September are supportive (or not) of approval, they are not included in the primary analyses comparing drug to placebo. That’s the reason why August is a problem and September is not.

Since you are familiar with breast cancer, you may recognize this trial design.  This “crossover” design, in which all patients are allowed access to the drug after the trial is done, is often employed in oncology trials.  It is an ethical consideration to allow patients who have participated in the trial to benefit from the drug, should it prove to be efficacious. Allowing this crossover complicates a determination of whether or not the drug provides a longer-term survival benefit, but in cancer, and in ALS, it is the only ethical way to proceed and therefore is a part of our trial.  I hope that this answers your question.  Also, if your physician has questions about the trial or treatment, I would be happy to have someone from our medical affairs team talk with him or her.

George

*************************************************************************************

My reply to the above message, July 25

Hi, George,

Thanks  for this explanation.

I have, I think, only one more question: if I’m forced out of the trial before the trial officially ends because I get a diaphragm pacer, will be I be among nonetheless considered to be “a patient who has participated in the trial” allowed access to the trial if it proves efficacious?

I think the answer this should be “yes,” but I want to be sure.

I’m very familiar with the cross-over design of cancer trials, and have argued with others about for years. But ALS is not cancer, as you know.

Thanks again.

Barbara

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Follow up message from me, July 25

Hi, again George,

I have one more question, and I thought I could save you multiple email repsonses.

If the answer to my question below about access to the drug if the trial proves effective is “no,” (which I don’t think it should be, given our exchange to date), will your company consider a compassionate (expanded) access program?

Thanks again.

Barbara

*******************************************************************

Response to above two messages,  July 26. 2012

Hi Barbara,

I’m sorry not to have responded earlier.  I had a family emergency and have been off line for the past 2 days (and will be only sporadically checking in for the next 3 or 4 days). However, I do appreciate the need to get you an answer.  Unfortunately I believe that I wasn’t clear.  In order to receive drug at the conclusion of the trial in September, you have to complete the trial, for all the reasons that we’ve been discussing.  We will have an expanded access program and will make drug available as quickly as we can.  We will make it available through sites that participated in the trial, so you should have access to the program.  I’ll check in with our clinical people to give you more insight into the timing of drug availability through that program (assuming that the trial is positive) and get back to you.  I believe that it will be around year-end, but I will get you a more accurate answer.

Sincerely,

George

***************************************************************************************

Thanks for getting back to me. This answer is clear. I will update my blog today or tomorrow. You might want to take a look in your copious spare time.

Barbara

Posted in ALS, ALS Treatment, Health Policy, Medical Science | Tagged , , , , , | 4 Comments

Broadening ALS Research to Help Patients — II

Posted on July 23, 2012 by bbzinger

Late last week I posted here a message I sent I had sent to the CEO of Biogen Idec, the company running the dex drug trial I’m in. I encouraged people to write to the CEO, Dr. George Scangos, about the company’s plan to drop from the trial anyone who gets a diaphragm pacer before the trial goes to open label in September of this year. That post is the one immediately below this one, called “Let’s Broaden ALS Research to Help Patients.”

Dr. Scangos has not replied to my message. But he did send a canned reply to the many people who emailed him on my behalf.

Based on that reply to others, I have sent another — more pointed — message to Dr. Scangos. That message is here. Also here is a copy of the doctor’s canned reply.

It’s not too late to email Dr. Scangos and tell him what you think. I hope you will. If you’ve already emailed and were unhappy with his response, my message here might give you ideas of what more to say to him. His email address is: gscangos@biogenidec.com, unless he changes it to avoid these messages.

This is not just about me, or just about dex. It is about all health research and whose interests it serves: when is it important to let patients decide what is in their best interest without being forced to make impossible choices? When being forced to make those choices makes no sense either in science or ethics.

© Barbara A. Brenner 2012

*****************************************************************************************

My response to Dr. Scangos’s messages about my request.

July 22, 2012

Dr. George A. Scangos

CEO

Biogen Idec

Via email:

RE: Continued participation in the dex trial

Dear Dr. Scangos:

As you no doubt know, I have not received from you the courtesy of a reply to my message to you of July 19, 2012. But people who contacted you on my behalf– some of whom I don’t even know — have forwarded to me the response you sent to them. I write to address what you say in that response in hopes of getting a prompt resolution to this very important matter.

I hope that, at some point, we can discuss ways to better design drug trials for the benefit of ALS patients, but what we need to resolve now is why Biogen Idec’s policies are inconsistent with the rules set up for this trial. You say in your message, which I have copied below, that each patient has to be followed for a minimum of a year. As I pointed out in my first message to you, I have been in the trial for 14 months. Under these circumstances, I fail to see — and you do not pinpoint — the exact violation of the trial protocol that my obtaining a diaphragm pacer at this stage would represent.

I am not asking for an exception to your protocol. I am asking that you implement policies consistent with it for the benefit of patients with ALS. To do otherwise is to hold ALS patients hostage to your trial. That is inhumane.

I fail to see — and nothing you say addresses — what inhibits you from doing a subgroup analysis of patients in the trial for more than a year who undertake other treatments thereafter, or cutting off analysis of their results after a year.

I understand that you need to protect the comparison between the placebo group and the treatment group. What I don’t understand is how, given the one year participation requirement of the trial, a diaphragm pacer in patients who have been in the trial more than a year would jeopardize that comparison.

This is not 1950. You have the capacity to do a staggered analysis of the data from this trial based on when patients entered it and one year has passed. As I understand  it, that is what your protocol requires.

I am entitled to and expect a response to this message.

Sincerely,

Barbara A. Brenner

****************************************************************************

Dr. Scangos’s message about my request

I have received 18 emails requesting that Biogen Idec allow Barbara Brenner to stay on the trial while she receives a diaphragm pacer, and they are still coming.  I am touched by the letters and it is obvious that Barbara has a great number of people who care deeply about her.  Our mission at Biogen Idec is to bring better treatments to people with ALS and with other neurodegenerative disorders.  We have physicians working for us who still treat patients with ALS, and we have employees with MS, ALS, and other degenerative diseases.  I, and all the employees of our company are keenly aware how devastating the disease can be, and that these diseases affect not only the patient, but their family, friends, and colleagues.  It is the desperate need for better care for these patients that motivates us to work the long hours that we do.

We are conducting the phase 3 trial of Dexpramipexole under an agreement with the FDA. The trial is intended to demonstrate whether or not Dexpramipexole has the ability to reduce the rate of disability progression and/or prolong the lives of patients with ALS.  Half of the patients are receiving drug, and half are receiving placebo. Neither the company nor the treating physicians know whether a patient is receiving drug or placebo, and we won’t know until the end of the trial when it is unblinded.   Each patient is being followed for a minimum of one year.  The last patient was enrolled in the trial last September and therefore the trial will be completed this September, after the 1 year period is reached by all patients.  One of the requirements to ensure that a valid comparison is made between patients treated with the drug and those on placebo is to ensure that they adhere to the same treatment protocols.  Therefore we have rules that a patient must meet to be included in the trial.  If we make exceptions to these rules, and patients begin to receive different treatments, then the validity of the comparison between drug-treated and placebo-treated patients could be jeopardized.  If that comparison is jeopardized, then our ability to determine whether or not the drug actually works also could be jeopardized,  and therefore its availability to all patients with ALS could be substantially delayed.  Therefore, we are unable to grant these requests because to do so jeopardizes the validity of the trial, which could prolong the time until the drug is available to all patients.

I want to make sure that you understand that the drug has not been proven to work.  The drug had encouraging data in a phase 2 trial, but there are many examples of drugs that had such data and then failed to demonstrate a benefit in larger phase 3 trials.  The purpose of doing the phase 3 trial is to determine if the drug does indeed provide a benefit to patients with ALS.  After the last patient finishes their 1 year treatment period, it will take some time to unblind and analyze the data.  We should know whether or not the drug provided a benefit later this year.  It is possible that the drug will not work.  In that case, we will stop the trial and move on to our other projects designed to find a treatment for ALS.  If the drug does appear to provide a benefit, we will work with the FDA to make the drug available to some patients even before it is approved.  We understand the desperate need for treatment and the importance of time for patients with ALS, and are doing everything we can to bring a treatment forward as quickly as we can.  I am deeply sorry, but we simply can not, however, allow deviations that could jeopardize the validity of the trial.

You should know that we remain committed to find a cure for this disease over the long term.  We just last week initiated a collaboration with Duke University and the HudsonAlpha Institute to sequence the genomes of 500-1,000 patients with ALS to understand the genetic causes of the disease.  Our own researchers are working hard and working with top academicians around the country to find better treatments, and ultimately a cure for this horrible disease.

On a personal note, I am deeply sorry that we can not comply with your request.  Please know that my thoughts are with you and that we are doing everything that we can.

Sincerely,

George Scangos

 

 

George Scangos, Ph.D.

Chief Executive Officer

Biogen Idec

133 Boston Post Road

Weston, MA 02493

tel: 781-464-3288

fax: 866-899-3970

 

Posted in ALS, ALS Treatment, Health Policy | Tagged , , | 4 Comments

Let’s Broaden ALS Research to Help Patients

Posted on July 20, 2012 by bbzinger

If you like this blog, pass it on to your friends. Let’s keep the conversation going.

ALS clinical trials are usually quite narrow. They test one device or drug only, and exclude

Researchers dong a clinical trial. See a patient anywhere?

people who are already participating in another trial. They are often limited to people who are within two years of their diagnosis. This works great for the drug companies who want to prove that their drug works. But, like placebo-controlled trials when the disease has no effective treatments and is always fatal, this approach is not in the best interest of patients. I believe this can be changed.

I am currently in a trial of an ALS drug called dexpramipexole (dex). I also am interested in getting a diaphragm pacer to help

Sometimes we need a little help to do this.

me preserve my ability to breathe. (How basic is that?) Biogen Idec, the company that is running the drug trial, says it will drop me from the trial if I get a diaphragm pacer. I wouldn’t mind being dropped from the trial — which I’ve been since May, 2011 — except that it would result in my losing the chance to get the drug if I’m on the placebo. If I’m out of the trial, I will have to wait until the drug is approved by the FDA, which could be many months away. I don’t have that kind of time at my disposal.

I’ve been told that the drug trial will go to “open label” sometime this September. That means that people in the trial who have been on placebo (and no one in the trial knows whether they have been or not, nor do their doctors — it’s a “double blind” trial) will be able to get the drug while the trial continues. Since today is July 20, it seems likely that even under the best of circumstances, I would get the diaphragm pacer less than a month before the open label period starts. Under the company’s rules, that’s “too soon” for Biogen Idec. I find it impossible to believe that this month is as important to them as it is to me.

I sent the following letter to the CEO of Biogen Idec. I haven’t heard back yet. If you think this matters, and you would like to do something to change how ALS research is done,

Dr. George Scangos, CEO of Biogen Idec

please send a note to Dr. Scangos. His email address is gscangos@biogenidec.com

Please send me a copy of your note, and let all readers of this blog know if you get an answer by posting it here.

If we can change this practice, it will tell us the power of ALS patients to influence the direction and structure of other research.

************************************************************

July 19, 2012

George A. Scangos, Ph.D.

CEO

Biogen Idec

Via email to: gscangos@biogenidec.com

RE: Continued participation in the dexpramipexole trial

Dear Dr. Scangos:

I am 60 year old woman with bulbar-onset ALS, diagnosed in November, 2010. I am enrolled in the dexpramipexole trial through the Forbes Norris Clinic in San Francisco. I have been in the trial since May 31, 2011, and have complied with the follow-up appointment schedule, which, as you know,  is quite demanding for people with ALS.

I understand that sometime in September the trial will become open label, and all those currently in the trial who are on placebo will be able to get the drug. I hope, as you do, that the trial is a huge success, not just for me, but for everyone else with this devastating disease.

Like others with ALS, I explore many options to try to maintain my health as long as possible. I have decided that one way to do that is get a diaphragm pacer. I am eligible for the device, and am awaiting Medicare approval.

The staff at Forbes Norris tell me that, if I get the diaphragm pacer before your trial goes to open label, I will be dropped from the trial. If I get the pacer after the trial goes to open label, I won’t be. I write to ask you, in the strongest possible terms, to reconsider this position.

If the diaphragm pacer makes no difference to the trial’s outcome in September, I fail to see the rationale for excluding patients who get the pacer now or in the near future. Why would you want to discourage ALS patients from doing everything they possibly can to lead productive lives as long as possible? Isn’t that your company’s objective with the trial?

In my life before ALS, I was a breast cancer activist. What I learned in that role is that things change because patients demand change. I’m asking you to do the right thing: allow me and others who get a diaphragm pacer in the next few months to remain in the trial.

I look forward to your positive response.

Sincerely,

Barbara A. Brenner

© Barbara A. Brenner 2012

Posted in ALS, ALS Treatment, Health Policy | Tagged , , , , , , | 4 Comments

The Supreme Court on Health Care II — The Medicaid Debacle

Posted on July 15, 2012 by bbzinger

If you like this blog, pass it on to your friends. Let’s keep the conversation going.

As you may recall, my most recent post expressed delight about the outcome of, and considerable skepticism about the motives for, the Supreme Court’s ruling upholding the Affordable Care Act. I return to that decision because the implications of the Court’s ruling on the extension of Medicaid are unfolding in very troubling ways.

What the Law Said Before the Court Ruled

Medicaid is a health care program for low income people. It’s run by the states, and, currently, the federal government covers a little more than half the cost. The Affordable Care Act, as written, required the extension of Medicaid coverage to people under the age of 65 (at 65, people are eligible for MediCare) who earn too much to be otherwise eligible for the program. (These newly eligible people are not rich, or close to it. The income cut off for a family of four is about $31,000.) The expansion of Medicaid — along with the individual mandate and subsidies for some individuals to enable them to purchase health insurance – was key to making sure more people who don’t currently have health care could get it.

To cover the costs of the expansion, the law provides that 100% of the additional cost imposed by the addition of new people to the program would be paid for by the federal government for the first three years. Thereafter, the states pick up an increasing percentage of the cost, but never more than 10%.

The law also said that stated that chose not to participate in the Medicaid expansion would

The classic carrot and stick approach. The Act used it to encourage participation in Medicaid expansion.

be penalized by losing the federal subsidy for their existing Medicaid programs.

What the Court Ruled

The Supreme Court’s decision said that the penalizing states that did not want to participate in the Medicaid expansion by depriving them of all their federal Medicaid funding is unconstitutional. If they participate, they get the huge federal subsidies for the expansion, but there is not penalty for not participating.

The Consequences

This is Justice Roberts. The smirk is that of a judicial activist.

Others have pointed out that the Court essentially rewrote the Medicaid section of the law in deciding the case, something courts are not supposed to do. (Remember, “judicial restraint” is supposedly a key issue for conservatives when they review judicial nominees.) As the impact of their decision plays out, the fact that they are not supposed to do it may explain why they did it.

The governors of some very large states with lots of poor uninsured people in them have announced that they do not intend to expand Medicaid coverage under the Affordable Care Act. Leading the pack are Texas and Florida. They are joined so far by Mississippi, Louisiana and South Carolina. Other states will likely join them. In Florida alone, that will leave approximately 950,000 uncovered people who would have had health coverage with Medicaid Expansion.

The governors cannot act alone. The state legislatures decide on the scope of the states’ Medicaid programs. But many of the states whose governors are saying no to expansion have Republican-dominated legislatures. Don’t expect the legislative debates to be any less morally reprehensible than the governors’ views.

If you need one of these, be sure the Governor of Florida isn’t holding it.

Consider this statement by the Republican vice chair of the Florida Senate Budget Committee: “Medicaid should be a last-resort safety-net program, and not a mechanism to reduce the number of uninsured. We have to hope our economy keeps improving and more people get back to work and therefore would have access to private health insurance.”  Medicaid is a last resort safety net program designed to guarantee health care for the poor. Expanding it covers more poor people, reducing the number of uninsured. Health care is the safety net. People don’t stay in the Medicaid program if they get jobs with health insurance. But hoping that happens is a very far cry from providing a safety net.

For the governors rejecting Medicaid  expansion, the position is an ideological one, not driven by financial concerns. After all, for the first three years of the program there is no cost to the states. The ideology is one that argues against federal programs on the grounds that  they amount to interference with the state’s self-governance.  The argument basically amounts to this: if the state wants to ignore the needs of the poor, they should be free to do so.

I believe that the Supreme Court, in ruling as it did on Medicaid, intended this outcome. It fits right into the philosophy of the right wing of the court (Roberts, Thomas, Alito, Scalia, and, too often, Kennedy) to undermine the federal government’s power to provide basic services when the states refuse to do so.

The Justices have a great health care plan. So do the governors, I imagine. I hope so, and hope their coverage extends to drugs to help them sleep at night.  For shame.

© Barbara A.Brenner  2012

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Wonders Never Cease — The Supreme Court’s Health Care Decision

Posted on July 2, 2012 by bbzinger

If you like this post, send it to your friends. Let’s keep the conversation going.

Since everybody and their cousin is commenting on the Supreme Court’s decision on the Affordable Care Act, I thought I would offer my two cents, for what they’re worth. Enjoy.

Will the Real Justice Roberts Please Stand Up?

I was very surprised by Justice Roberts. Having watched him vote his Republican, capitalist, protect-the-property-owners and corporations philosophy in many cases, I never suspected that he would be the member of the court who would save the health care act. I was at first pleasantly surprised, until I thought about it a little more. Sure, calling

Actually, the law imposes a penalty, not a tax.

the individual mandate a tax kept Roberts from voting with the Neanderthals and invalidating the law. But calling it a tax also saddles President Obama with having to explain increasing taxes. That’s just what the Republicans want to pin the President down with. Maybe it’s just a convenient outcome of the Roberts’ opinion, or maybe it’s more nefarious than that.

Crazy on the Right

Speaking of Neanderthals, what is with Justice Kennedy? Alito, Scalia and Thomas would never vote to protect the people, so their positions were no surprise. But Justice Kennedy knows better — and often votes that way. What possessed

Neanderthals have small brains. The Supreme Court ones have small hearts.

him to take the position that this law is unconstitutional under the Commerce Clause? I wonder. I really do.

Of course, the right wing is wondering the same thing about Justice Roberts. But they have a theory. According to Michael Savage, right wing talk show blatherer, Roberts upheld the law because he was undermined by cognitive side effects of an epilepsy drug he takes.

What Role Self-Interest?

Let’s assume for a minute that Roberts takes such a drug. At least it would be covered under the health care law. So maybe it was self-interest after all that drove Justice Roberts to vote to uphold the law.

It’s sort of like Justice Sutherland in Village of Euclid v. Ambler Realty Co., the landmark zoning case. Sutherland wrote the majority opinion upholding a zoning law that prohibited building an apartment structure in a neighborhood of single family residences. The story goes that Justice Sutherland had only to imagine an apartment building on his residential block to uphold the zoning restriction against such construction in Euclid.

Hijacking the Discussion: The Right Does It Again

Maybe the real surprise with this decision is not the decision at all, but that so many people believed it would come out the other way. When the cases challenging the health care law were filed raising the Commerce Clause issue, the argument was mocked by legal scholars. Not many people believed it would be seriously considered.

But the right wing was organized, and it wanted to win the Commerce Clause argument.   So the right did what is so good at: it got its version of the story into the press, through talk show hosts, Sunday talk shows, Fox, and print media. The press bought it uncritically, and the Commerce Clause argument took hold. It took such a strong hold that both Fox and CNN initially (and wrongly) reported that the argument had prevailed with the Supreme Court.

So the discussion of what the law requires was hijacked by the right, which was supported by the press. And the press coverage since the decision still focuses largely on what people on the right think.

Some of those people are showing up in comments on news articles about the Supreme Court’s decision. My favorites are the guys (and all the comments I saw were from men) who swear that since the U.S. now has a socialist or communist health care system, they are moving to Canada. I can’t make this stuff up, but I wonder if they know that Canada has a single payer health care system. We have a universal health insurance system. They are different, but these guys seem to not understand either system. I wish them well in Canada.

Moving Forward

The Affordable Care Act is step forward to getting everyone health care. It’s not what I want or what I think we need, which is a single payer system. But it’s better than what we have now: it will prohibit denying coverage based on pre-existing conditions, it bars life-time caps on coverage, it covers kids until they are 26 under their parents’ plans, and it will cover a lot of people who don’t have health insurance now.

What I wonder is how we can get the uninsured and the under-insured to recognize that this law will make them better off — and vote in November.

© Barbara A. Brenner 2012

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Previews in Health Redux

Posted on June 26, 2012 by bbzinger

If you like this blog, pass it on to your friends. Let’s keep the conversation going.

Regular readers of this blog will have read my post a while ago called “Whatever Happened to Preview of Coming Attractions in Health.”  I return to the topic now to reflect on what I have learned since posting it, and to encourage more conversations on this very important topic. After all, most of us are likely to be seriously ill at some point in our lives.

This is the Facebook logo. If it’s not familiar to you, where have you been?

I’m active in several ALS communities on Facebook, and posted the earlier blog there. In response, a very helpful person posted information about an manual for people living with ALS published by the ALS Society of Canada.. If you’re interested, you can find it here.

In reviewing the manual, both my partner and I were struck by the level of detail and usefulness of the information, and disheartened that we had not been given this resource or anything like it by the specialty ALS clinic at which I am seen. The Forbes Norris Clinic where I receive care promotes a slate

The Hebrew 10 Commandments. These are useful.

of 10 Commandments for Optimal Motor Neuron Disease Patient Care, originally formulated by Forbes Norris himself. (In Europe, ALS is called MND – Motor Neuron Diseases.) It’s posted prominently at the clinic.

 

If you compare the “10 Commandments” to the Canadian manual, I think you’ll agree that the Canadians resource is much more helpful. Turns out that Canadians are good a lot of things besides hockey.

It’s been pointed out to me that the 10 Commandments were written at a time when there were no multi-disciplinary clinics for ALS. I have no doubt that, in that environment, it was helpful for care providers to be

Does this really help?

reminded that “positive thinking can heighten morale.” But this is 2012. Patients with ALS have no doubt heard about the power of positive thinking. It’s not practical advice, any more than is “keep the patient involved, informed and updated.” In fact, the 10 Commandments seem directed to the care providers, not the patients.

I have no doubt that staff at the Forbes Norris Clinic know most of the information in the Canadian manual. But I haven’t discovered any systematic or anticipatory way in which they share it. It’s the patients who need to be better informed.

To their credit, some of my care providers read this blog and my Caring Bridge site, and respond positively to my concerns. I’m told that I am not the usual ALS patient. Most people don’t want to know what’s coming because they get depressed. I’m sure this approach of not offering information until it is requested is not peculiar to the Forbes Norris Clinic. But the assumption that people — or their loved ones — would rather not know is just that, an assumption. Why not ask patients and their families how much they want to know and provide the relevant information? Or let them know that the information is available if they want it, and  whom to ask for it.

It is simply not helpful to ALS patients to tell them that some center across the country has a good guide, or that the ALS Association (despite all its funding) has symptom management booklets that need updating. This is the age of the internet and extensive

It’s really not hard to stay connected

communication among treatment centers. The professionals at the centers should vet the available information, and make it easily available to patients and their families.

And patients shouldn’t have to ask for the information. At every check up appointment, patients should be asked what information they need. And it should be given to them.

The Forbes Norris 10 Commandments say the patient is in charge. I would like to believe it. But to be in charge, patients need relevant information, provided n a timely manner.

© Barbara A. Brenner 2

Posted in ALS, ALS Treatment, Illness | Tagged , , , , , | 3 Comments

If you want to sign a letter calling on Nancy Brinker to resign

Posted on June 15, 2012 by bbzinger

that was written by a former New York Komen Affiliate Board Member, email me at barbara@barbarabrenner.net, and I’ll send it to you.

Note that the letter says things I wouldn’t have written, but I signed because I believe Brinker has to go.

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Susan Love: Time to Think Before You Pink

Posted on June 5, 2012 by bbzinger

If you like this blog, send to your friends. Let’s keep the conversation going.

There are many heroes and heroines in the world of breast cancer. You even know some of

Dr. Love, whose name appears on everything she does

their names. One of the best-known is Dr. Susan Love, author of Dr. Susan Love’s Breast Book, the excellent layperson’s guide to breast cancer issues. I have given that book to several people, and referred many others to it, as a clear and invaluable source of information for sorting out questions about breast cancer diagnoses and options for treatment.

Dr. Love stopped doing surgery some years ago, and now runs a foundation, called — you can guess it from the title of her book — The Susan Love Breast Cancer Foundation. Founded in 1995, its mission is “to eradicate breast cancer and improve the quality of women’s health through innovative research, education and advocacy.” (On the subject of the holy grail of “eradicating breast cancer,” see Breast Cancer Action’s Cancer Policy Perspective.) According to its last annual report, the Foundation has nearly $5 million in assets.

Eradicating breast cancer was not always the Foundation’s stated mission. In 2005, its stated mission was “to end breast cancer in 10 years.” I was then the E.D. at Breast Cancer Action, and had heard similar elusive promises from others many times. But I thought of Susan as more honest than most people in the field, so I was surprised. I emailed her to ask

Why does it always seem to come down to this?

from what year we should start counting the 10 years. She responded, “My board says when we raise all the money.” Oh yeah, the money thing. As 2015 approaches, the mission has changed. Either they didn’t raise all the money they needed or they saw that they couldn’t deliver. Surprise.

I have known Susan Love for a long time, and – despite her excellent book – disagreed with her about several things along the way. When we first “met” in 1994 at an on-line breast cancer forum, we disagreed about the value of breast self-exam. We still disagree about that. Susan says it sends women on a fearful “search and destroy” mission that doesn’t do any good. I say that discouraging women from knowing their own bodies is a dangerous thing, especially when about 1/3 of women with breast cancer find their own lumps.

But more recent events have intensified my disagreements with her. Here’s why:

Both Susan and I appear in the film that’s opening now across the country, Pink  Ribbons,

Open now or soon at a theater near you

Inc. In that film, Susan convincingly says we have to find the cause of breast cancer and stop it. In the film, she eloquently suggests that environmental research may be the key, and that people who want to support that kind of research should be sure that’s where their money is going. It’s clear to me that this call is for more funding for her foundation.

So far, so good, right? But Susan can’t really be that interested in environmental causes of breast cancer, because, if she were, she couldn’t accept some of the funding the Foundation has accepted or establish partnerships the Foundation has established.

I suspected as much when the Foundation announced to great fanfare its “Army of Women” approach to getting women involved in breast cancer studies. The Army was launched with the help of funding and publicity from the Avon Foundation.

(An aside: I was appalled at the name at the time — just what we need, another militaristic reference in the cancer world. See some discussion of this in a previous post.)

I was also pretty sure that the partnership was a direct result of the fact that Love was serving on the Avon Foundation’s Breast Cancer Scientific Advisory Board at the time. If you don’t think this is how funding works, think again. Look at the list of who serves on a non-profit research funder’s advisory board, and see if you don’t find many of those names also on the list of the funder’s grantees.

So, what’s the problem? Avon (the corporate parent of the Avon Foundation) refuses to sign on to the Campaign for Safe Cosmetics, and continues to use known or suspected carcinogens in some of their products. This corporate hypocrisy is also highlighted in Pink Ribbons, Inc.

My suspicions about Susan’s commitment to environmental health research were confirmed recently when Susan announced with great pride that her foundation has been

More war language

chosen to benefit from the Ford Motor Company’s “Ford Warriors in Pink Models of Courage” campaign. The Foundation will get the “net proceeds” (that means after costs are covered, so it could be little or nothing) of sales of things like Warriors in Pink: t-shirts, yoga pants, and sun hats, to name a few items. You can array yourself in much Ford Warrior in Pink apparel.

The Ford Motor Company is also featured in Pink Ribbons, Inc. Ford has a history of being the leading polluter in the automotive industry. And we know that some of things that are produced by internal combustion engine cars can increase the risk of many cancers, including breast cancer. Beyond that, the film includes a sequence that focuses on the elevated incidence of cancer in women who worked in automotive plastics factories, making parts for Ford. Ford’s purported concern about breast cancer is classic pinkwashing. And Susan Love is helping them do it. For shame.

Susan says in the film that she hates pink. But she partners with companies that are pinkwashers. Will the real Susan please stand up?

I invite you to join with me in calling on Susan Love to run her Foundation with the same integrity she exhibited in Susan Love’s Breast Book. You can reach her at slove48@gmail.com.

 

© Barbara A. Brenner 2012

 

Posted in Breast Cancer, Environmental Health | Tagged , , , , , , , , , | 27 Comments

Tobacco Company Lies Don’t Mean You Should Vote for Prop. 29

Posted on May 23, 2012 by bbzinger

Apologies to readers who are not California voters. I need to talk briefly about Prop 29, the initiative on the June 5, 2012 California ballot. It’s a proposal to raise the state’s cigarette tax by $1.00 a pack to fund cancer research.

A little background before I get to my reasons for voting no on this proposition. The current tax on cigarettes in California is $0.87 per pack. That’s not the highest (in fact, California ranks 33rd among the states; the highest tax is $4.35 per pack in New York), but it’s pretty high as a percent of the cost of a pack. A few years ago, when this initiative was first contemplated, a study was done of the impact of raising the tax. The study found that increasing the tax would drive more smokers to the black market to buy cigarettes and that revenue from the cigarette tax would actually decline.

I have no reason to believe that that study would lead to different results if done today, given the economic realities that most people are facing.

But even if increasing the tax would generate more revenue for cancer research, I would still vote no. Here’s why.

Cancer research has been very well funded in the U.S. for about 50 years. We have no idea how much the total dollar amount is because there are so many agencies, organizations and companies doing the funding, but it’s in the big multiple billions, if not trillions, of dollars. What do we have to show for it? Not much, given the investment. So, rather than pouring more money down the black hole of cancer research, let’s spend some effort to get accountability for the research we have already so generously funded.

And, while I have no doubt that tobacco companies are lying about the impact of this initiative, I note that the major sponsor is the American Cancer Society (ACS), which has been lying to the American public about many things about cancer — from what constitutes a cure for cancer to what mammograms do and don’t do — for as long as it’s been in existence. I don’t trust the ACS either So, a pox on both their houses.

Vote No on Prop. 29

© Barbara A. Brenner 2012

Posted in Health Policy | Tagged , , | 6 Comments

Odds and Ends in the Pink Ribbons Wars

Posted on May 17, 2012 by bbzinger

If you like this blog, send it to some of your friend. Let’s keep the conversation going.

The Language of Cancer

You know doubt have noticed that the language of cancer is drawn largely from a bellicose framework. Women with breast cancer are “fighting” the disease. Women who die have lost their “battle” with cancer. The federal government runs a “War on Cancer.” The drugs available to treat the disease are called — I didn’t make this up — the “armamentarium.”

Maybe the war language is meant to remind us that, like the war in Afghanistan, or the

The War on Cancer Needs You

Second World War, we can never give up, because giving up means not winning. Maybe it’s also meant to remind us that, like all wars, this one is expensive, so we’ve got to give to keep it going.

Advancing the War: More Pink Silliness

Of course the easiest way to support the cause, as we’ve been repeatedly told, is to buy something with a pink ribbon on it. Or, almost as good, carry something pink to show how much you care about women’s lives.

It seems the silly season in pinkness arrives annually now with Mother’s Day. After all, if you care about mothers, breast cancer should be your cause, shouldn’t it? (Things like economic security, child care, or education never seem to make the grade on Mother’s Day marketing for some reason.) This year, as in other recent years, the silly quotient was maxed out for me with major league baseball players, using pink bats in Mother’s Day

They really use these

games.

Can anyone tell me how using a pink baseball bat will change anything in breast cancer? Or anything at all having to do with women? An activist colleague noted that the teams don’t use

They don't use these

pink baseballs, maybe because that would be too emasculating. But pink bats and batting gloves — “real” men use them.

While Major League Baseball — of which I am a fan — has had its challenges with public perceptions (like the steroid use issue, for example), it looks like a goody two-shoes compared to the National Football League. Several years ago, in an effort to distract people from the criminal activity of many of its players — often involving violence against women — the  NFL got into the pink game with pink cleats, head bands, and players’ gloves.

The NFL effort was encouraged and enabled by none other than Nancy Brinker, founder and leader of the Susan G. Komen for the Cure Foundation. A little like the Midas of breast cancer, everything Brinker touches seems to turn pink.

Komen Departures Mount, But Brinker Stays

It seems that Ms. Brinker is determined to hold on at the Komen Foundation until she either drives it into the ground or dies trying. In the latest departure from the executive ranks at Komen, Leslie Aun, long-time VP of Marketing and Communications has left the organization. While she declined to give a public reason for her departure, I have some evidence that she left because Brinker wouldn’t.

I know how the Komen email addresses are set up, so I periodically send messages to members of the leadership. Not surprisingly, I have never received responses to these missives. Nevertheless, ever persistent, I sent an email to Leslie Aun on a recent Saturday. My motivation in doing so was to respond to a quote from her in a review of the film Pink Ribbons, Inc., saying she hadn’t seen the movie. I wrote to suggest that she see it, if for no other reason than that she would want to see Brinker’s performance in it. I closed the message with my view that Brinker should resign.

After I sent that email, I read in the New York Times that Aun had submitted her resignation. Imagine my surprise to get an email response from her indicating that she had been trying unsuccessfully to get Brinker to resign.

Learn More, Support the Cause

I don’t want anyone to think that because pink marketing has gotten beyond ridiculous or Komen has lost its way, they shouldn’t support the breast cancer cause. While it’s true that more women die of lung cancer and heart disease, they don’t die at the young ages that so many women with breast cancer do. And the problem is so far from solved that we have to keep working until we can say with confidence that the next generation of women is not facing the scourge that ours is.

There are many breast cancer organizations that deserve your support. My favorite is Breast Cancer Action probably because I led it for 15 years, and I agree with the organization’s vision and applaud its integrity and its work. If you are interested in supporting Breast Cancer Action while at the same time learning more about how the breast cancer movement got diverted from activism to shopping, here’s a great opportunity for folks in the San Francisco Bay Area:

On the evening of May 31, Breast Cancer Action is hosting a fundraising sneak             preview of Pink Ribbons, Inc. Information and tickets are available here.

And wherever you live, don’t miss the film when it opens soon, hopefully in a theater  near you.

Communicating With Folks at Komen

By the way, if you want to send messages to anyone at Komen, the way their email addresses work is first initial no space last name @komen.org. So for example, the email address for Liz Tompson, Komen’s President, is eThompson@komen.org. If you send a message and get a response, be sure post it here.

© Barbara A. Brenner 2012

Posted in Breast Cancer | Tagged , , , , , , , , , | 5 Comments