I recently celebrated a milestone in the rock world, just as the Beatles predicted, I finally turned 64!
I grew up with this Beatles song in a time far removed but never gave it too much thought because it always seemed so far into the future. But now that I’m actually 64, I guess I finally caught up with that future and I see it in a whole new light.
Here’s a thought: What if a candidate picked his or her running mate in advance? One would be president, the other would be vice president but they would run as a team. So you would get the best of both, each with a clearly defined areas of responsibility, working together for the good of the country. Isn’t that what its all about?
When I heard that Uncle Joe Biden and Senator Elizabeth Warren were having informal talks this weekend, I got to thinking, what if they ran together? Who would be the president and could they put aside their egos?
Would that be legal or even possible?
The 2016 race is still ridiculously far off but it’s already creating a lot of hoopla and it’s not all Donald Trump. Trump and Bernie Sanders generally represent opposites on the political spectrum and that’s a good thing. If nothing else, they will stir the pot and I think that’s a good thing at this stage. Maybe another question would be, can any “outsider” candidate get by the status quo?
I sure don’t have all the answers—what do you think?
We just keep getting hit by the greed and madness on all sides. When will it stop?
There’s a law making it’s way through the US Congress, The 21st Century Cares Act, that among other things, would allow drug manufacturers to use a drug designed to treat one condition, to treat a different condition and to expedite the development of these drugs, establishing a “streamlined” data review program. Folks we don’t need to streamline most drug approval processes.
I actually agree with most of the 21st Century Cures Act—on the surface.
I am all for research and development. There is no doubt that we have plenty of diseases and conditions that need answers and this legislation would certainly help funding and fast tracking. But if you dig a little deeper and look into research by organizations not associated with big pharma and medical industry “think tanks”, you will see a different picture.
Too much of today’s research is done by those who benefit most from fast tracking risky drugs to treat made up diseases and conditions. It’s all about big bucks and it’s killing us. By all means, find the answers! Increase funding opportunities and come up with innovative approaches but DO NOT fast track and streamline research review! If nothing else all research should be subject to more review if human health could be endangered. We are not paying enough attention to side effects that are always present when you fool around with Mother Nature. Sadly, money is the root of all evil here because too much of it is at stake. Without the streamlining research part, this bill would do much to help us move forward.
Apparently there is a lawsuit in the works by a small drug manufacturer against the government claiming it has a First Amendment right to say whatever it wants about any medication it produces — even if those claims have never been approved by the FDA! Are we out of our minds here??!! This would disastrous to our health.
Get more details below from my friends at The Health Sciences Institute https://hsionline.com/
They say the price of freedom is vigilance, and right now there’s a legal battle happening in New York that we all need to watch closely.
Because our freedom… particularly our freedom to protect our health and lives from risky and unapproved drugs… is under attack.
A small company most people have never heard of has just sued our government on behalf of the entire drug industry. They’re claiming they have a Constitutional right to claim whatever they want about their drugs — even if those claims have never been approved (or have been outright rejected) by the FDA.
Now, a district court judge in New York holds the key to possibly opening that risky and lucrative door for Big Pharma. But I’m sure this wasn’t what our founding fathers had in mind when they sought to protect our right to free speech.
Don’t tread on us
“If this lawsuit were to prevail, it would be devastating for drug safety,” said Dr. Michael Carome, an expert on prescription drugs and the FDA.
He’s talking about a federal lawsuit Amarin Corp. filed against the FDA earlier this month, claiming it has a First Amendment right to say whatever it wants about any medication it produces — even if those claims have never been approved by the FDA.
If Amarin doesn’t ring a bell, you’re not alone. It’s a small company that makes just one drug, Vascepa, that’s only been approved for very high triglyceride levels linked to diabetes, kidney failure and pancreatic cancer.
And when the FDA wouldn’t let Amarin expand the drug’s use without some supporting science and clinical trials, the company lawyered up.
But the lawsuit isn’t about one company or one drug. Amarin is going to bat for the entire drug industry, which has long claimed it should be able to say anything it wants to doctors.
Big Pharma even wants to present information such as early clinical trials — which have been paid for by drug companies and have never been peer reviewed — to promote a wide and unapproved range of uses for its meds.
It’s a billion-dollar scheme called off-label marketing, and it’s not (quite) legal. Not just yet, anyway.
Right now, doctors are free to prescribe drugs off-label at their discretion. Like the use of risky antidepressants for hot flashes. Or a med intended to lower blood pressure being prescribed to calm your nerves.
But drug companies like Amarin are demanding the right to directly promote these off-label uses to doctors and encourage them to prescribe drugs for unapproved — and potentially dangerous — uses.
Being able to offer that information is worth billions to the drug companies — and it’s long been their holy grail.
There’s even a coalition called the “Medical Information Working Group,” made up of the biggest names in the business like Eli Lilly, Pfizer and Sanofi. Its entire purpose is to push the envelope when it comes to being able to tell doctors whatever they please.
Dr. Joshua Sharfstein, who once worked at the FDA and is now an associate dean at Johns Hopkins, said that people do not realize that the consequences of this new approach to free speech “will be measured in lives.”
But the drug industry has been pressuring the FDA over off-label marketing for years, and previous rulings have already set some dangerous precedent.
A 2012 decision, for example, overturned the conviction of a drug salesman for promoting the off-label use or a narcolepsy drug to physicians, citing the First Amendment.
As a result, the FDA has said it’s looking to “realign (its) regulatory posture.” Translation: even the agency isn’t sure how much it can police what Big Pharma says anymore.
So it looks like drug companies will try this maneuver again and again until they succeed. Or until the FDA gives up and gives in.
For Dr. Rita Redberg, editor of JAMA Internal Medicine, the issue of giving drug companies carte blanche to claim whatever they want about their meds comes down to a pretty simple principle.
“You don’t ask the barber if you need a haircut.”
She’s watched drug sales reps push the envelope with wild, unproven claims for years — and then she banned them from her medical center.
But companies like Amarin know there are still plenty of doctors out there that they can reach. In fact, Amarin wrote a letter to doctors letting them know that it has new training and promotional materials it’s ready to send right away — if it wins its suit.
As a columnist for Forbes said about the Amarin case, “free speech is paid for, often handsomely.”
And the more than $24 billion a year Big Pharma spends on drug marketing can buy an awful lot of it.
To Your Good Health,
The key is to be vigilant, stay informed and stay thirsty my friends—thirsty for good health!
It’s been a tumultuous and challenging year of change here in America and all over the world. Yet through all the lunacy and strife, the United States of America still stands as our last beacon of hope.
But only if we work together will we find our way.
This is a day we should celebrate that all of us have the right to life, liberty, and the pursuit of happiness. We should remember the sacrifices that early Americans made to gain this freedom for us, and appreciate the sacrifices that our military men and women and first responders make every day to protect this freedom.
I am a registered Democrat but I vote for the best person regardless of party affiliation. Really, the only reason I’m a Democrat is so I can vote in the primaries. I tend to vote for candidates who are sincere, well grounded and not beholden to special interests but quite frankly there are not a lot of them out there.
The race for the White House in 2016 will be epic and it will be interesting to see how it all shakes out especially on the Republican side. I have done a complete about face on Hillary. Her conduct as Secretary of State for the most part was inexcusable. She has way too much baggage and feeling of entitlement really turns me off. I really hope somebody in the Democratic party can step up but that’s a long shot.
On the Republican side it’s a full house but the practical side of me leans toward former Florida governor Jeb Bush. I think he’s more of a centrist, more practical and his job as governor was a big plus—even though many question whether we need another Bush in the White House.
But then Donald Trump entered the race. Though he is at best a long shot (talk about baggage!!) how bout this scenario?
What a great 3rd party ticket—more money and more drama—the all inclusive POTUS.
Only one problem—The Donald’s hair would never stand up to the rigors of a presidential campaign!!
Today is a day to remember those who sacrificed to keep us safe—those who put the free in freedom. I think about it everyday, not just today, now more than ever.
I grew up in the Vietnam War era, a terrible time to serve in the armed forces but I so admire those who did. I regret EVERYDAY how poorly those guys were treated when they got back. They were spit on for being a part of an unjust war—no parades, no Honor Flights, nothing but disdain for serving the country they loved. Some of them didn’t have a choice because they were drafted, but they were there for their country and yet nobody cared. It was a terrible time in our county’s history but for whatever reason they were there for, they did their jobs and got hardly a thank you.
I for one am determined to do all I can to make this wrong right. Support your first responders, military, police, fire rescue—no matter when or where they served. They are the ones who stand between us and the bad guys.
I left the Catholic church years ago because I was tired of the pretentiousness, the hypocrisy, the sometimes meaningless routines, and the inability of organized religion to address the everyday issues of the flock while staying true to the teachings of the Lord in the Holy Bible. My father was devastated but recognized that I needed to find my own way.