Compassionate Freedom of Choice Act Could Save Many Lives

April 15, 2014
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New legislation would prevent the FDA from denying appropriate experimental drugs from dying patients. Action Alert!

Recently, by working together, we made great strides in helping dying patients win access to potentially lifesaving treatments. It was your messages, together with those of other grassroots activists, that convinced the FDA to grant 12-year-old McKenzie Lowe a right of access to Dr. Stanislaw Burzynski’s innovative antineoplaston treatment.

As you may recall, the FDA had insisted that the treatment go though the agency approval process. Although the treatment had proven effective in earlier years and had passed the agency safety tests, it had not completed the whole process. The FDA had the authority to grant “compassionate use” to patients who asked for it and would clearly die without it, but chose not to grant it.

Despite our recent victories, the fact remains that the compassionate exemption rule is broken beyond repair—after all, these patients needed government permission to try to save their own lives, and the government couldn’t care less.

That’s why we’re thrilled that last Thursday, Rep. Morgan Griffith (R-VA) introduced the Compassionate Freedom of Choice Act of 2014. The bill eliminates the requirement for an FDA okay, and streamlines physician and patient access to experimental drugs. It would ensure that dying patients and their families—who don’t have the time or the strength to do so—won’t have to wage fruitless bureaucratic wars.

As Rep. Griffith told ANH-USA, “The Compassionate Freedom of Choice Act would empower patients battling deadly diseases with more control over their health care decisions. For patients whose doctors have exhausted current medical options and the patient has been told that the end of life is nearing, why should the government in Washington care what treatment the patient may choose? If I’m dying anyway, shouldn’t I have the freedom to decide if the risk is worth it?”

It couldn’t be clearer that the FDA’s compassionate exemption rule is not working. Under the current rule, individual patients may apply for access to experimental treatments outside of a drug trial if they have a serious or life-threatening disease or condition, have no other treatment options left, and can persuade a qualified physician to deliver the treatment. But the program is marred by a prohibitively cumbersome application and documentation process, and the agency arbitrarily refuses access. It can even revoke permission after it has been granted.

The program is so slow and troubled that patients are forced to turn to social media and their legislators to plead for what should be their right. As one parent recently told CNN.com, “My son was dying. He was hemorrhaging four liters of blood a day. When exactly was I supposed to call my congressman?” The same CNN article also criticized the rule, but placed the blame on drug companies, which are also involved in the permission process.

The Compassionate Freedom of Choice Act removes disincentives for drug companies to grant exemptions. For example, the current application for expanded access requires a drug company to share information—which we all know drug companies don’t do very well. It also requires, among other things, a detailed description of how and where a drug will be produced; complex pharmacological and toxicological information; and, if enough patients ask for the drug, a whole new Investigational New Drug (IND) application by the drug company.

Under the new bill, drug companies can still deny dying patients access to experimental treatments. But if they don’t have the FDA in opposition, drug companies may be much more willing to say yes. For example, drug companies are often afraid that if a patient dies under expanded access treatment, it will affect the eventual approval of the drug. With less risk and less paperwork, drug companies are more likely to increase patient access to experimental drugs.

The call for reform of the compassionate exemption program is rapidly building: in April 2014, Louisiana and Colorado have passed “Right to Try” bills, which will facilitate patients access to experimental drugs. Similar bills in Missouri and Arizona have gained considerable momentum, and may be signed into law soon.

Action Alert! Ask your legislators to support the Compassionate Freedom of Choice Act—tell them this is their opportunity to save countless lives!


13 Responses to “Compassionate Freedom of Choice Act Could Save Many Lives”

  1. Guy Chapman says:

    This is an interesting proposal, in that it is the very opposite of the Cancer Acts in the UK and Australia, which recognise the uniquely vulnerable nature of cancer patients by protecting them from unevidenced claims. What this bill will do, is declare open season on cancer victims. Any crackpot theory will be covered, as far as I can tell, even theories that are definitively disproved like Gerson and laetrile. Obviously you folks probably think that’s great, but think about it: the open season also applies to Big Pharma. They would have no incentive whatsoever to play straight in trials of any end-stage drugs, they will just be able to invoke this and “do a Burzynski”, an end-run around clinical trials legislation.

       0 likes

  2. Jerry Lambert says:

    It seems only right to allow a dying patient the right to exhaust all possibilities. Have mercy for heavens sake !!!

       0 likes

  3. Joyce Calabro says:

    Take Action on this bill. IF it was your loved one you would want them to have the opportunity to choose what they wanted to do, NOT be dictated to.

    Let’s start taking action in this country. God Bless the USA,

       1 likes

  4. R.w.Foster says:

    Yes! Let’s give him more victims! You know, like Laura Hymas. You should remember her. She’s the one these people said Burzynski cured in November. She died 13 Apr 2014. Of the very thing he claimed to cure her of. https://twitter.com/Roochella/status/456050899950243841

    Remember her. None of these folks will.

       0 likes

  5. CYNTHIA LA CROIX says:

    Do not deny hope. Many denied drugs are already approved in Europe. Where is or leadership?

       2 likes

  6. Linda Hite says:

    I have been following Dr. Burzynski for many years and know of excellent results with people with no hope who have recovered. Government has given him a hard time for years. I think they’re afraid he knows what he’s doing he has cured many people.

       3 likes

    • CH says:

      Questions not being asked, it seems, are:
      1. will this change end up giving BigPharma yet more latitude at pushing drugs to market prematurely?
      2. would this change in law really allow alternative, non-mainstream “experimental” healing methods, such as those offered by Burzinski and others? or serve to block them in other ways?

         0 likes

  7. Jean Hoagland says:

    Please give this serious consideration. People who know they’ve their lives and are not well should be permitted to pass on easily with whatever drugs are available.

       1 likes

  8. The link to the Compassionate Freedom of Choice Act of 2014 is broken. I did find the text at http://www.cooscountywatchdog.com/1/post/2012/08/hr-6342-compassionate-freedom-of-choice-act-of-2012.html.

    I used to work for a pharmaceutical firm. Even though it won’t be required for companies to share the data of the compassionate use patient, they will still be afraid that the FDA will punish them by taking longer to review their New Drug Applications if they don’t “cooperate” and do so.

    The problem with data sharing is that if a terminal patient dies of organ failure due to their disease, the FDA will want to be sure that the drug didn’t contribute to it. This means more studies for the pharmaceutical firms. Companies fear being punished for being compassionate.

    This bill is a step in the right direction, but will probably not make investigational new drugs as available as one might hope.

       0 likes

    • Larry says:

      This is only with the smaller maybe pharmaceutical companies. The large ones pay off the FDA to quickly get approval. This practice should be stopped.

         0 likes

  9. Denise smith says:

    I support this bill for compassion law for anyone seeking help

       1 likes

  10. Jan Lindner says:

    When someone is DYING, what harm is there in giving them a chance at life.

    IF SOMEONE YOU LOVED WERE IN THAT POSITION, WHAT WOULD YOU WANT?

    Do unto others, people. A lot of politicians CLAIM to be Christians; I’ve seen damned little evidence of that being the case.

       3 likes

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