In a Twitter post on Tuesday, Dr. Scott Gottlieb, the commissioner of the F.D.A., said, “When the House passes #RightToTry legislation I stand ready to implement it in a way that achieves Congress’ intent to promote access and protect patients.”
The chief sponsor of the bill, Senator Ron Johnson¹, Republican of Wisconsin, said that it “expands the scope of individual liberty” and provides “hope for terminally ill patients who have nowhere else to turn.”
Critics said the bill was not as innocuous as it sounded. It was opposed by many Democrats and by dozens of organizations that represent patients, including the National Organization for Rare Disorders and the lobbying arm of the American Cancer Society.
The right-to-try bill “could greatly increase the likelihood of our patients being harmed by unsafe and ineffective experimental therapies,” the health groups said in a letter to House leaders.
“We are deeply saddened,” said Ellen V. Sigal, the chairwoman of Friends of Cancer Research, an advocacy group. “This bill endangers patients and will offer them no value, just false hope.”
The main lobbies for the drug industry, the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization, said they had not taken a position on the bill.
Under the bill, a patient is eligible to receive an unapproved drug if he or she has “a life-threatening disease or condition” and has “exhausted approved treatment options and is unable to participate in a clinical trial” of the drug. Sponsors of the bill said it could help people with cancer, muscular dystrophy and Lou Gehrig’s disease, also known as amyotrophic lateral sclerosis, among other conditions.
“Why do you not want to allow these patients to exercise their right to fight for their future?” Representative Michael C. Burgess, Republican of Texas, asked opponents on the House floor.
Twenty-two Democrats joined 228 Republicans in voting for the bill. All of the no votes were cast by Democrats.
Patients will have to provide informed consent in writing before obtaining an unapproved drug under the bill. Manufacturers will have to provide the government with an annual summary of use of the drug, including “any known serious adverse events.”
Nothing in the bill requires pharmaceutical companies to provide experimental drugs to patients who request them. Drugmakers sometimes turn down requests because they have only a limited supply or because they are concerned about legal and medical risks.
To address such concerns, the legislation would shield drug companies, doctors and hospitals from some of the legal risks of providing unapproved drugs to patients. Doctors and hospitals would generally be protected unless they engaged in “reckless or willful misconduct” or “gross negligence,” or intentionally harmed a patient.
The House passed a similar bill with more protections for patients in March, but the Senate never took it up. So the House decided on Tuesday to pass the Senate bill.
Several former commissioners of the F.D.A. and some clinical experts at the agency said that the bill was unnecessary because patients with a serious illness could already obtain experimental medicines through a program known as expanded access or compassionate use.
The agency says it approves 99 percent of the requests it receives under this program, but in some cases, it recommends changes to protect patients before allowing the treatment to proceed.
Mr. Burgess said consumers had gained access in recent years to many innovative treatments. But, he said, “We continue to hear from patients with serious life-threatening conditions who remain frustrated with what they see as regulatory barriers to trying new therapies when everything else has failed them.”
Representative Frank Pallone Jr. of New Jersey, the senior Democrat on the Energy and Commerce Committee, said that reputable drug companies would not provide drugs to patients without the blessing of the F.D.A. But, he said, the bill opens the door for “a bad actor, some unscrupulous manufacturer, a fly-by-night outfit to promote something like snake oil, whether the F.D.A. approves it or not.”
Mr. Pallone said the bill’s definition of a life-threatening disease could be stretched to allow access to experimental drugs for people with manageable conditions, like severe diabetes or chronic heart failure.
Scientists would need to complete the first phase of clinical research on a drug before it could be made available under the bill. Phase 1 trials typically assess the safety and toxicity of a drug in a small number of volunteers.
The drive for right-to-try legislation was spearheaded by the Goldwater Institute, a public policy organization that advocates free markets and limited government. Starlee Coleman, a spokeswoman for the institute, said that 40 states had adopted right-to-try laws in the past four years.
“‘Right to try’ is the opposite of ‘right to die,’” Ms. Coleman said. “It is for people who are not ready to stop fighting.”
Article source: nytimes.com
For the principles of you owning your body, and have a natural human right to decide what you believe your body should be able to try and explore is the main reason why we support this legislation. Among the red tape that comes with such personal yet controversial decision, the job of Congress and the Senate is to ensure the Constitution is enforced through the written agreement of protecting YOU, your life and liberty by eliminating as much political barriers as possible that interferes with those choices.
However, we at ToxicHungr isn’t taking this TOO personal based on the government’s long track record and rap sheet of “passing” certain laws at certain times as more of a convenience than a need that the public is in dire need for. Not trying to be pessimistic about this legislation, but as always..we smell a huge rat here.
Let us explain…
Being able to make your own decisions regarding your body is an automatic right given to you at birth. So we’re not celebrating Congress “giving you the privilege” to have the right to try, we’re celebrating barriers being knocked down so that you CAN express your right to try experimental drugs when everything else failed.
Ask yourself this question; why is it that after all these years, states are NOW legalizing cannabis marijuana? Why now? What are they doing with those plants NOW, that they can tax it? And what interest do they now have in the sale of cannabis besides “tax revenue”?
The same question with experimental drugs. If you’re not aware of how the government works, they are in the psychological business. So did they buy themselves some time to find out how to control the “experimental drug” business while keeping it under the control of the FDA? And was the FDA there to be a distraction, a decoy of the “experimental drug” until they had full control of the pharmaceuticals that made these same drugs? Check this paragraph out…
“…Drugmakers sometimes turn down requests because they have only a limited supply or because they are concerned about legal and medical risks…..To address such concerns, the legislation would shield drug companies, doctors and hospitals from some of the legal risks of providing unapproved drugs to patients. Doctors and hospitals would generally be protected unless they engaged in “reckless or willful misconduct” or “gross negligence,” or intentionally harmed a patient.”
And the definition of “reckless or willful misconduct”, “gross negligence”, “or intentionally harmed patient” solely lies upon the official opinions of the Supreme Court? We’re calling bullshit.
Our point here is not to discourage you from trying experimental drugs since Congress made it easier for you to do so, but not allow your emotions cloud your judgement to ask the previous questions above so that you can be prepared if this legislation was passed for nefarious reasons. We just see the government as suspect of lots of dirty tricks of interfering with the developments of products and services AFTER they gain control of it, and win the hearts of those who’s been suspicious of the FDA for a long time. Remember, the government itself has ALWAYS been in the psychological business, and they’re very good at it.
¹Oh before we forget, if it peaks your interest, we highly suggest finding out Senator Ron Johnson‘s financial interest in this bill for our conspiracy analysis fans.
*Remember that symbol behind “approval of their doctors..”? Based on a large percentage of the pharmaceutical industry controlling the curriculum of medical doctors and practitioners. Details here.
THE BOTTOM LINE: Get to know YOUR BODY. Learn about your body. No matter how “powerful” you believe the FDA, Congress, or the pharmaceuticals, including doctors are, no one on this earth knows anything about your body except YOU. It all boils down to getting knowledge about your body, find yourself, get to know about your body, and not base it on what THEY say you’re allowed to do and not allowed to do. As long as you depend on an outside source; government, media, news, doctors, regulators, pharmaceuticals, or the underworld, you’re body is going to be negativily affected by those thoughts towards your health! TM
Know YOUR body more by clicking HERE.