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Right to Try: A Call to Arms

People I respect have told me Right to Try is feel-good, unnecessary, and toothless legislation. What I hear is them telling me no, again.

Right to Try is a call to arms for ALS patients to demand access to potentially life-saving treatments that exist today.  There are possible treatments sitting in the pipeline with years to go before they receive FDA approval.  Tens of thousands of people have died waiting for an effective treatment. Most of us living with ALS today will die before these drugs get to market.

That is not OK with me or my friends and family who love me.

Even before Right to Try legislation (which removes the FDA paperwork requirement) passed in 33 states, qualifying patients and doctors could petition the FDA to get access to treatments in the pipeline under the Compassionate Use or Expanded Access Program. The lengthy paperwork processed has been trimmed and the FDA approves most of the requests. So what’s the problem?

Drug companies are in the business of making money by selling drugs, and they can’t sell a drug until it gets FDA approval. It takes 7-10 years and 2.5 billion dollars to get a drug approved. There are no incentives for drug companies to provide unapproved drugs to patients under Expanded Access or Right to Try. They only face risk, liability, and perceived interference with clinical trials.

So there you go. Thousands of people die because the drug companies can’t tolerate any more risk or liability.  Can the FDA alleviate the risk and liability? Yes. Will they? Not yet.

I say not yet, because I believe it can happen. 

I was interviewed for a recent Sacramento Bee Article.  The reporter did a fair job presenting all sides of the argument. My favorite quote is, “There’s a lot in the pipeline; we have nothing that works, and we’re dying quickly,” Hoover said. “I’m extremely persistent, and I will keep asking until I get a yes. My alternative is to do nothing and die. It’s worth a fight for me to do it.”

I have a real problem with the quotes from Don Nielsen, director of government relations for the California Nurses Association. He said he’s concerned that patients will become “guinea pigs for the pharmaceutical industry.”  I’m already a guinea pig for the pharmaceutical industry. So that’s not an issue.

He went on to say, “The reason no one in the process wants the liability is because (the drugs) haven’t yet been tested.”  Wrong. A drug has to pass Phase 1 safety and tolerability  trials before being eligible for Expanded Access or Right to Try.

Neilson continued, “It’s potentially a very unsafe situation for a patient. They’re being exploited by drug companies that could make a lot of money off the individual and not be held accountable.” I would love to have a sit down with Mr. Nielsen and explain to him that I have already taken a greater risk by participating in the Phase 1 trial — it was the first time the drug was tried in humans.  Also, drug companies can’t charge a patient more than it costs to manufacture. How much I spend on a drug and the risk I am willing to tolerate is not his concern. Here’s your nose back Mr. Nielsen, I found it in my business.

The ALS community is perfectly positioned to put Right to Try to the test and persist until we get a yes. The patient criteria is like an ALS biography:

  • Terminal diagnosis
  • Exhausted all available treatments
  • Ineligible for ongoing phase 2 and 3 efficacy trials

Check, check, and check. ALS is 100% fatal. We have no treatment, and we are not eligible to participate in phase 2 or 3 clinical trials 24-36 months after symptom onset.

We need to come together and demand access to potentially life-saving treatments. The time is now.

Tricket me beth

Pictured with me are two other women with ALS. We were in Washington DC in 2014 asking legislators for research dollars. Beth on the right is still in the thick of the fight. Sadly, Trickett in the red jacked died before an effective treatment was found.  Carrying her name, the Trickett Wendler Right to Try Act of 2017 will provide federal protection for states that have approved Right to Try laws.  Here’s a link to the recently passed California legislation AB-1668 if you would like to read more about it.

Quite frankly, I’m pissed. The solution is simple, even the FDA says it’s possible.  Yet most of the medical community and pharmaceutical industry are against it.

They are literally protecting me to death.

I spoke at a conference a few weeks ago about designing patient-centric clinical trials. Of course, I brought up Right to Try to the audience of pharmaceutical employees. One astute participant asked me, “What do you think needs to happen next?” I replied that the FDA needs to remove the risk from drug manufacturers and put into writing that compassionate use will not jeopardize their clinical trials. And secondly, and more importantly, the ALS patient community needs to get loud and demand access.

Remember in the early 80s when people were dying from AIDS? Treatments existed and patients didn’t have access. Angry, dying people acted up and persisted until patients got access to life-saving drugs. Now AIDS is a treatable, chronic condition. They didn’t passively wait decades for the FDA, medical professionals, and drug companies to work it out.

We can’t wait any longer either if we want to live.

Where does compassion intersect industry responsibility? I say here and now.  I will not take no for an answer and neither should you. Ask your neurologist for access to drugs in phases two and three. If he or she says no, find a neurologist who will support you.  If your state hasn’t passed Right to Try legislation, ask under the Expanded Access program.

My ALS friends, we must unequivocally and unilaterally persist.  We cannot stop when we hear a no. Go around it. Start a social media shit storm. Do whatever it takes. We have to because our lives depend upon it.

I’m Forgiven and Free, extremely persistent and will be putting Right to Try to the test

p.s.
Please share this post and add your wisdom as to how we can make this happen. Imagine  if several hundred or several thousand of us showed up in our power chairs! I just had a vision of us being arrested and the officers having to use Hoyer lifts to get us into the police cars. That would be fun. Let’s do this.

 

Hey White Friends — Here’s Our Chance 

white-people-550x309

Are you tired of being called a racist, homophobic, xenophobic bigot? Now’s our chance to do something about it. We implore leaders in the Muslim community to denounce the terrorist actions of extremists. We demand that leaders in the African American community denounce gang violence or violence against police officers. So what does our silence say when half the country thinks this represents the Trump Presidency? We must denounce this hateful rhetoric. Our silence makes us complicit.

divided

Three years ago the ALS Ice Bucket Challenge validated me. Millions of people dumped ice water over their heads and many donated money. IBC videos saturated social media. I felt people were saying directly to me, “I see you. I hear you. I recognize you have experienced struggles as a person with ALS that I don’t as an able-bodied person.” Seems such a simple gesture, yet it was liberating and empowering to me.

We now have the chance to validate and empower communities who are feeling marginalized by the rhetoric of the recent election and actions of the very few racists people who feel they have been given permission to express their hate.

What an opportunity we have. Imagine the message we will send when liberals and conservatives stand together and say, “We want liberty and justice for ALL Americans.” It’s a simple gesture that could possibly validate the experience of Americans who are feeling left out of the conversation.

I can hear the arguments now. I’m not a racist. It’s not my responsibility. The law says we are equal. I haven’t done anything to them. Not my problem. What if we look at it from another perspective? What if we recognize that forms of white, male, abled-bodied, Christian, heterosexual privilege exists? Wait! Don’t stop reading now. Please give me another few minutes.

Our current silence speaks volumes and I’ve been part of the problem. I’ve been railing against my white friends who don’t get it. Those who refuse to acknowledge that the experience of others is America is not the same as their own. Most of us have not been oppressed by the dominant culture, so how would we know what it’s like?

I didn’t get it until I was 47. I spent three years working closely with a cohort of educators that included people who were white, black, Latino, Native American, and other races. We were Muslims, Christians, agnostics, atheists, and Wiccan.We were women and men, straight, gay, and lesbian. We were first generation Americans, Americans who families came on the May Flower and slave ships, families who were indigenous to America and everything in between.

I was changed by this loving group of people. They shared their lives and stories with me and I realized how privileged I’ve been. Does that make me wrong or bad? No. Should I feel guilty? Absolutely not. Can I recognize that my experience of living in America has been different than many of them? Absolutely, yes. This doesn’t mean they have had miserable lives or lack opportunities. It simply means that they have encountered different struggles or challenges that I do not face being a white person.

This brings me back to how I felt after the ALS Ice Bucket Challenge phenomenon. Should people without physical disabilities feel badly or defensive because they are able-bodied? No. That’s a ridiculous thought. Can people without physical disabilities acknowledge that I encounter difficulties or obstacles that they do not? Absolutely. Something as simple as the Ice Bucket Challenge validated this for me.

It’s undeniable that groups of Americans feel marginalized and left out of the conversation. Well, I guess you can deny it, that’s a white privilege. But the fact remains that many Americans feel this way. So how should we respond? We can name call and tell them to accept the voice of the electoral college and get over it. My guess is, if you are still with me, you don’t like that option.

Our continued silence is not a option.

The time is now to send a loud and clear message to our fellow Americans that we see them; we hear them. We acknowledge that their experience of living here is different than our own. We have the responsibility to take the first step.

Don’t know what to do about it? I didn’t either. So I researched how to be a white ally. I paid particular attention of authors of different races than me. I learned not tell others what to do, what to feel, or how they should fix it. I learned the most productive things I can do is talk to my friends and family about white privilege and join groups that follow the lead of activism led by people of color or other marginalized groups. Here’s my first two steps: 1) I joined the Sacramento Chapter of Showing Up for Racial Justice, and 2) I’m marching on the California State Capital on January 21st to support the rights of women. Americans from all over the country will march in Washington DC.

Too radical for you? Start a group called “White guys who want liberty and justice for ALL Americans.” It’s up to you how you show up. But we must act now.

 

 

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