Posted on 01/11/2016 11:00:25 AM PST by Kaslin
Darcy Olsen, CEO and president of the Goldwater Institute, has written a must-read book for anyone facing a serious ailment, The Right to Try: How the Federal Government Prevents Americans from Getting the Life-Saving Treatments They Need.It is common knowledge there is a problem with the FDA delaying the approval of drugs. But until now, most Americans did not realize just how bad the situation is — hundreds of thousands of people, including children, needlessly lose their lives every year because new, breakthrough drugs that have worked in clinical trials and are legal in other countries are not approved here. In fact, the number of people dying is increasing, because the FDA keeps increasing the delays — despite its false claims that it approves drugs faster than it really does. The FDA continues to demand more data and statistical certainty from clinical trials, making them "larger, longer and more complex."
The agency insists that unless a treatment has a high success rate, it should not be approved. But everyone is different; some people respond differently than others to medications. Peter Huber of the Manhattan Institute explains, "There is no such thing as breast cancer," because scientists "have discovered at least ten distinct variations." Therefore, indiscriminately testing one drug on all breast cancer patients is going to have skewed success results.
The FDA isn't even delaying approval in order to establish the safety of a drug, merely to measure its effectiveness. This is cruelly unfair. As Darcy puts it, people with terminal illnesses like Lou Gehrig's disease (ALS) or cancer would rather have a 50 percent chance of being cured than a 100 percent chance of dying from it. One doctor sarcastically stated, "These people would be happy to go to their own funeral five years from now rather than a year from now."
Darcy relays the stories of several people with different terminal illnesses who went to great lengths despite the FDA to obtain these new groundbreaking treatments. Some moved overseas, while others persisted until they were allowed to participate in the clinical trials. Most of them were not rich so it was a difficult, uphill task, but the treatments ultimately worked.
Perhaps most disturbing of all is what I think should really be called child abuse. Darcy lists the high numbers of children who die every year of terminal illnesses, who could have been saved had they been given these treatments. Even the clinical studies are cruel to children. Some are driven by their parents hundreds of miles every month or so for the chance of just a handful to participate in a trial, only to be part of the placebo group that does not receive the real drug. Darcy calls this "morally unacceptable."
It is fascinating learning about the new treatments. One of the new methods that is working effectively to kill cancer and other serious illnesses involves sending a virus into the patient's body to infect the cancer cells. If the virus doesn't kill the cancer cells first, the body's immune system will kick in and kill them. Thus, HIV is being used to cure leukemia. Other drugs in the works will combat depression, traumatic brain injury, schizophrenia, PTSD, mesothelioma and Alzheimer's. Positive results have been achieved already reversing Lou Gehrig's disease, leukemia and more — but virtually none of these drugs have been approved by the FDA.
Most Americans don't know about these successful but unapproved new treatments, because their doctors aren't telling them. One pediatric doctor told Darcy that most of them are too afraid of retaliation to stand up to the FDA.
In order to get around the FDA, Darcy and allies have worked to get Right to Try legislationpassed at the state level. So far, 24 states have approved of the legislation, which lets terminally ill patients try new drugs before the FDA has approved them if they meet certain minimal criteria.
One way Darcy recommends reforming the FDA is to implement "a policy of regulatory reciprocity with countries that have a proven record of approving safe and effective drugs — including the European Union, Canada, Japan and Australia." People from Britain are surprised when they learn they have access to drugs that Americans can only dream of having years down the road.
It is heartwarming to think of all the Americans who will read this book and use it as a guide to figure out how to obtain these prohibited lifesaving treatments. My brother died from leukemia in 2009; had my brother had one of these non-FDA approved options, he might still be with us today. In 2012, a seven-year-old girl named Emily Whitehead sought experimental treatment for leukemia. Doctors "genetically engineered her own blood to kill cancer," known as T-cell immunotherapy. The leukemia completely disappeared and she has been in remission ever since.
Fortunately, considering how dry of a topic this could be, Darcy has written it as a series of human interest stories about the patients involved, making it impossible to put down. She should be commended for not only shining light on one of the most horrific problems in society, but for saving many lives. Dr. Jonathan Bell, an award-winning scientist at the Center for Innovative Cancer Research at Ottawa Hospital Research Institute in Canada, perhaps summarized the problem the best: "It's unethical to withhold these treatments if there's a potential there."
Good catch!
I have worked for and with a major global pharma company for several years. I had one 30 year+ scientist tell me that drugs like asprin and Ibuprofen would be by perscription only if they were introduced today. People want to vilify “big Pharma” but have no idea what goes into the research, development and approval of usefull drugs to get them to market. When you factor in the short amount of time that they can be proprietary, these folks have to not only cover the years of R&D that went into the drug but also cover the costs of all the drugs that didn’t or won’t make it to market in the pursuit of cures and treatment. Factor in again the fact that “big pharma” can’t make money for their approved medicines in other countries and their drug prices necessarily have to skyrocket. It’s another deal that government involvement creates a problem that everyone hollars at government to fix.
There is certainly good reason for oversight in medicine. But the oversight is not being managed by industry experts. It is being managed by beauracrats. Hence the costs and delays.
24 states have Right To Try laws.
Basically, if you’re dying of a terminal illness and a new drug exists that would save or extend your life, you and your doctor can now acquire it if its in current clinical trial.
For people who are very sick, taking away their last hope is unethical and its wrong. The government should always err, as a matter of principle, on the side of saving life.
If your state doesn’t have a Right To Try law, work to get it passed. Every patient deserves every treatment option available. Our right to decide how to live out our lives should be our decision alone.
Yep, when pregnant European women where able to avoid morning sickness by taking Thalidomide, the FDA was keeping it away from American mothers to be.
Oh, to go back to the good old days when Massengill (later part of GlaxoSmithKline) could take Elixir of Sulfanilamide straight to the market without government interference.
Hysterical myth.
If these life-saving drugs were commercially available outside of USA no one would be dying here. It is not all that difficult to get grey market drugs. The burden of efficacy proof in Spain is not what it is in USA.
But you can thank the thousands of lawyers poised to strike if a new drug does not have volumes of evidence of safety prior to US commercialization.
I give anesthesia for a living. 12 years ago I was working with an anesthesiologist who was visiting from Israel, he was giving Tylenol in IV form for years. However, it was not approved in the US until I think 2010?? Crazy stupid.
Safety as in Gardasil? Yeah the FDA did a stunning good job on that one.
***Applause***
Totally agree. They can start by extending patent lives (IMHO) Then, really take a look at the clinical trials are conducted...double blind studies o very sick patients?
FDA’s Pazdur finally saw the light...once his own wife became ill and eventually passed from ovarian cancer.
Good article.
Three groups are behind this murderous policy:
1 - The Population Control, or “Duty to Die” crowd.
2 - The multi-BILLION dollar Cancer Care industry and similar, who make a mint on half-way measures.
3 - The paper pushers at the FDA who make a living from ever expanding research and study, allegedly to ensure safety and effectiveness.
If the FDA was abolished tomorrow the drug industry would replace it within 3 months with a private equivalent, and we would all be far better off. The FDA was a child of the progressive era (founded in 1906), and it does far more harm than good. Underwriters Laboratory (founded in 1894) is an example of how the free market provides for necessary safety testing.
Aside from its gross inneficiency, the primary problem with the FDA is its chronic abuse of police powers.
New Zealander Allan Smith was saved from death due to flu in 2009 with intravenous vitamin C.
http://jeffreydachmd.com/vitamin-c-saves-dying-man/
http://www.naturalnews.com/037210_Auckland_hospital_vitamin_C.html
The reaction of the FDA to this medical “miracle” was swift and decisive. They ordered the American manufacturer of the intravenous vitamin C that saved Allan Smith’s life to stop making that “unapproved drug”!
http://www.fda.gov/Drugs/DrugSafety/ucm248280.htm
Nice non-sequitor. Good job there.
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Good info. Thanks.
Bmp4L8R
yeah, but i get turned off when the push off label use on television, make 100 times the fines they end up facing, and move to the next lie.
like with neurontin. and others.
that they only have to hand over successful tests and that they pay the companies that check the drug’s safety are two things that need to change.
i’ve studied the research behind how they say antipsychotics boost antidepressants. it is a REACH at best.
and the deceiving ads. like 1 out of 3 people who get blah blah will die. but they make it sound like one out of three people in the country WILL get it.
unfortunately my mother was a nurse and since my father needed a zillion pills for REAL reasons, after he passed she shoved them on me at a young age and i became a piller.
that being said, once i got to my 20s, i thought for myself.
and in all fairness, stomach meds, antibiotics, and meds for colitis DID work. neurontin, lyrica and cymbalta for pain did nothing.
and for a couple of years after pop’s death, without klonopin i would have suffered needeless terrible anxiety. i used it till i was better and never got addicted.
great post by the way.
i have a nice with thalasemmia, a Mediterranean disease. there as a better treatment out there that needed a bunch more money to perfect and pharma wasn’t interested because not nearly enough people had the disease.
it turned out well because they refined the drug for another illness and it happened to help my niece
but i didn’t blame them and neither did one of her BROTHERS.
they’re for profit it is what it is.
i LOVE my cousin and donate to her, FR, and wounded vets.
BTW, where can i find brain injury treatments overseas :)
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