Atlas Shrugged with Our Stem Cells

LLL6521

Member
Hiding under an altruistic motive to protect the general public, when in fact an ulterior motive exists to protect self interest, and consequently hindering individualism and choice, to a point that raises the ultimate nagging question, who owns you and your body? Sadly, exponential growth of more government regulations and control hiding under the altruistic motive for the “greater good of society,” we continue to lose more and more of our own rights, until you wake up one morning asking yourself what happened to my civil liberties? As Khrushchev said, “We'll spoon feed you socialism until you're Communists and don't even know it." We are not there yet or even close, however, our current trajectory points to that direction.

I have a dream just like Martin Luther King had his own - walking down Manhattan with a 17 oz. soda along with crunchy French fries cooked with transfats, then go to San Francisco and buy a happy meal with toys for my kids, then open up a Chick Fill-A in Chicago, then drink raw milk anywhere, and then the very best for last, having my own stem cells extracted then manipulated for treatments from medical doctors anywhere in the U.S. In other words stealing the words from Ayn Rand from the classical novel Atlas Shrugged, “We want to break the laws…” Besides, our founding fathers have dreamt it, wished it, and wanted for all of us to fight and pursue it. It is the American virtues this country was founded on and stands for. Gee, I guess I have had enough of the moronic nanny statism!
 

Connie

New member
As a woman I too have a dream, but I not only dream of the right to use my own stem cells to heal myself, my dream includes the rights that my generation already fought for and won, (but seems to be being brought back up for debate)..... that is the right to decide what is done with my body and that includes my uterus and reproductive rights. It appears to me that the people who claim to want less government want to take away those rights and govern my entire body. That does not make me feel all warm and fuzzy about how they might feel about my stem cells. What are we to do? It seems that neither of the choices put in front of us today are going to help us achieve our dreams.
 

barbara

Pioneer Founding member
Connie - I have yet to be persuaded that women will be denied access to contraceptives or abortion with a change in Washington. The argument is about who funds these and quite frankly, my generation paid for its own birth control. Better idea - make birth control an OTC drug which gives access to more women. The FDA has actually shown some interest in doing this. I certainly hope they will get serious about it.

Abortion should become all but obsolete in my opinion except when a woman's life is endangered. This has nothing to do with religious beliefs for me. The morning after pill is available without prescription for anyone over the age of 17. We live in a new age and technology that wasn't available in previous generations is now, so why live in the past?

I believe both parties have members who are abortion extremists. We have the far left who advocates abortion upon demand, no matter how far along the pregnancy is. On the far right we have those that do not believe a woman should be able to terminate a pregnancy at any point after conception. The majority in this country are more moderate than extreme. The far left needs to quit shoving abortion as a means of birth control down everyone's throat and the far right would do well to embrace the morning after pill. It prevents implantation of the fertilized egg into the womb. Without implantation, there is no pregnancy. It is much safer than an abortion, so why doesn't Sandra Fluke and her posse get young women on board and educate them about the use of it after having unprotected sex? Every rape victim should have it given to them immediately. Why doesn't the far right learn the science of this drug? It's because this issue is being used politically and for all the wrong reasons, much like those that tell us they are "protecting" us when they rail against allowing us to have treatment using our own stem cells. I refuse to drink the Kool-Aid.

President Obama appoints the FDA commissioner. The FDA is the one who is regulating our own stem cells as drugs. Politically, the Democrats have fought for federal funding for embryonic stem cell research. This is where their interests lie. However, iPS stem cell research is overshadowing embryonic stem cell research. I don't believe Washington has caught up to that fact yet and continues to embrace embryonic stem cell research. They also like to use it as a political weapon claiming that Republicans are the ones who have stymied stem cell research and have made patients suffer for it. There are also those with their own special interests, including the FDA itself. There is simply no money to be made by research scientists (many of whom hold patents that they hope will be worth billions of dollars for them and their research facilities), Big Pharma, the FDA and others with conflicts of interest when it comes to patients getting treated with their own stem cells by doctors. Physicians would be the only ones to really profit.

Millions of people could benefit by adult stem cell treatment right now, not decades from now. I believe that the present administration will not fight to remove the regulations that have been put in place. Believe me, there has been a lot of lobbying to do so and nothing has come from it. Rand Paul will introduce a bill this fall and many of us are working to have autologous stem cell therapy included. This would allow terminally ill patients access to treatment. A lot will depend on who is in power as to whether or not this bill or any other bill like it will be passed or if the FDA will be directed to remove the regulations against our own stem cells.

With the options for reproductive age women to pay for their own birth control, thus keeping the government from controlling that aspect of their lives, and the widespread availability of the morning after pill (which seems to be kept a secret by those who rally around abortion), I will not be basing my decision to vote on issues that easily can resolve themselves if people become more responsible and educated to what is available to them, instead of worrying about who will pay for it. There is such a small demographic involved of reproductive age women and such a huge demographic of people who are sick. This should be considered as well.

LLL6521 has a small child. He is fighting for his child. I agree with him wholeheartedly. Enough is enough of the nanny state. Quite frankly, I am confused as to why millions of people dying who might benefit from their own stem cells is of no concern to those who take up causes such as unlimited abortion and free contraceptives. When I hear about another patient who has died, I don't think about if only he could have had free contraceptives or if only she could have lived long enough to make sure her granddaughters could all get access to abortion, I think about how horrific it is that no one cared enough to rally for the basic civil rights of these people to access their own body parts.
 

Connie

New member
Barbara, It seems you missed my point. Which had nothing to do with abortions for all and free birth control. It was about how both sides seem to think they can control what we do with our own bodies. You can't give the government the rights to part of your body and not other parts and not expect them to take it all.

But, since you seem to want to make it a political argument if you believe that the right is going to jump in and save your stem cells when they take control of your grand daughters uterus you are delusional. They are not just about the money they are pushing their religious beliefs on the masses and educating our youth about birth control is not an option since the same people fight to keep sex education out of our schools and fight to have abstinence taught as the only form of birth control.

I am neither a republican or a democrat, and I believe you know that I too have my life at stake, and that I pay my own way, but as I see it both sides or extremist and no part of me believes that either side has my best interest at heart.
 

Donna

New member
Governor Perry is the one who opened the doors for adult stem cells in Texas. He's a conservative pro life governor who I don't necessarily agree with on many things, but he did open the doors so it is possible to have support for some parts of the body and not for others contrary to what you said. A good friend of mine had treatment at Celltex in Texas a couple of months ago.
 

LLL6521

Member
Connie,

It does make sense what you’re saying. For example, under Bush, we've had over 50,000 government regulations past. However, one ideology or philosophy is worst than the other. Here is an article I wrote 6 months ago. I hate to view my political views in this forum, but I guess being an election year, and we all trying to reach the same goal - I will share it.


Obama’s Paradox of Fighting His Own Success

When our founding fathers gathered to discourse on how our nation should govern and legislate, they reached a consensus for a Constitution, a government with lesser restrictions, lesser taxation, more personal liberties, and rewarding those with opportunities for prosperity and riches for all, everything that England was unable to provide. Now, we have a President with an agenda to assault and set forth legislations to disavow our historical legacy and constitution by emulating the very source of our original avoidance, a way to emulate England’s monarchist government.
Remembering the words of Thomas Jefferson’s from his first inaugural address, which have echoed for generations, “…wise and frugal Government, which shall restrain men from injuring one another, shall leave them otherwise free to regulate their own pursuits of industry and improvement, and shall not take from the mouth of labor the bread it has earned.” Now we have a President that has advocated the opposite, “…I think when you spread the wealth around, it's good for everybody," said Obama. Obama again, in a 2001 interview on our Constitution, “…generally the Constitution is a charter of negative liberties.”
The Constitution has successfully been pursued historically by our nation’s leaders as our supreme law and acculturated with those beliefs of less government restrictions, and more liberties, and from thereon adapting the doctrine gave us the very foundation our founding fathers dreamt, the rise of economic superiority, greatest standard of living in the world, and most of all a beacon for all to emulate with enduring liberty and democracy for all to witness. Now, President Obama sets forth an old contrived agenda defeated time and time again in history of trying to spread wealth by burdening the very seeds that fruit success. Moreover by discrediting our founding fathers as unfair and unjust, he layers the groundwork of a different course of action by instituting bigger government, higher taxes like our European neighbors.
Never in the history of this republic have we ever had a President so blatantly repudiate those doctrines bestowed by our founding fathers that has blessed us with exceptionalism, enduring prosperity, and freedom. Now that we live with the self evidence of the greatest prosperity in the world, do we radically oppose those founding convictions, or do we govern our nation with laws and solutions that only add and adhere to them like intended? Is it not obvious that original foundation of our great republic demonstrate fairness, justice, and liberty by having the first African-American President elected? Have we really witnessed the same fairness elsewhere like England or France by electing any minority as their leader? Does this not prove that our founding fathers’ economic vision of opportunity and prosperity works for all Americans? With all the obvious blessing bestowed on our nation, is it not self evident that our Constitution should be revered and held sacred? One must ask themselves one question, who does the President attend to help and represent, all Americans regardless of race, color or creed, or those he deemed as “dispossessed people” not justly protected by the constitution with opportunities and fair economic prosperity? Does he truly believe that all Americans would benefit from more entitlements inevitability burdening our nation with debt, higher unemployment, more regulation, and most alarming driving our nation into eventual bankruptcy? Whose “hopes” does Obama have in mind to cater to, and what kind of “change” does he intend for our nation?
 

barbara

Pioneer Founding member
I don't like to delve into politics either, but this is a critical election. My work for the last 6 years has been as a patient advocate who believes that sick people should have the right to use their own stem cells in a clinically relevant manner. This has been taken from us due to over regulation and special interest groups.

We are drowning in a sea of regulation in my opinion and there is no sign it is getting any better. I am particularly saddened when millions of people are able to mobilize and declare that there is a War on Women and yet no one seems to care that there is a War on Patients. It's not just stem cells, it's also experimental drugs that dying patients are not able to access. I will admit I have a problem with the enthusiasm being generated for women of child bearing age to be able to have federally funded abortions vs the almost non existent attention being paid to sick and dying patients being denied access to their own stem cells or an experimental drug. I have heard no one even suggesting that patients should get federally funded stem cell treatments. Instead, we are just denied no matter who pays for it.

I also don't understand why science is being ignored. There are some wonderful discoveries, the morning after pill being one, stem cell therapy being another, and instead of embracing science, the majority seems to be ignoring it.

There is some hope on the horizon with Rand Paul's bill and a couple of others that would give terminal patients access to experimental drugs. It would be nice to have stem cells included.
 

Bobcat

New member
Here's some food for thought. Many experts believe that there will be a shortage of doctors because of the Affordable Care Act aka ObamaCare.
There are a lot of organs in the body, not just uteruses and stem cells. Those needing a heart transplant for instance or bypass surgery may find themselves on a waiting list. Indeed, some may die while waiting.

I have read that some experts believe that the ACA will eventually result in a two tier system far worse than we have now. Those that can afford it will get better care from concierge type doctors who will not accept Medicare and Medicaid patients. Those on Medicaid and Medicare will have to wait as there simply won't be enough doctors to take care of all the new people included in ObamaCare.

I'm not saying this is going to happen, I'm saying this is what many experts feel will happen. You cannot expect medical doctors to take a big mandated pay cut and continue to see patients that don't generate the revenue that other patients do. I know we like to think of doctors as wanting to help all and I think most do, but they also have a business to support and families of their own.

I actually like the idea of vouchers. This allows a person to pick and choose what services they want. If someone wants birth control then use your voucher to get it. If someone else wants blood pressure medication, then use your voucher for that. If you use an alternative medicine doctor, use your voucher for that. Catastrophic illnesses should be covered beyond the voucher. Face it, many people overuse the system. They run to the emergency room for just about anything and it's costing all of us.

I don't feel much thought was put into the ACA beyond politics and it's a cinch no politician who voted for it seemed to have the foresight to think about doctors not rejoicing over a pay cut. I think we could do a lot better. Already, it needs reform. It's no wonder the majority of people in this country do not like the plan. I would like to see it repealed or at least a promise from the Democrats to reform it.
 

LLL6521

Member
In conclusion, one is being denied, and the other is not. Not trying to marginalize the topic of woman’s choice, but that is for another forum. This one is trying to gain the best care and treatments that are accessible for us and our love ones. I am sure Connie’s point about both sides has some truth to it with the facts of more and more regulations from wherever it’s from stalls our progress. My fight right now is having the rights to our stem cells. Every time I hear a news report that has researchers inject their false words of wisdom of what is truly a conflict of their own interests they are protecting, it ticks me off. I see it as an underlying message coming across as ‘the hell with Lawrence my son and everyone else that is fighting for their own stem cells.’

Barb, last night they repeated the same 60 Minutes report of Dr. Kutzenburg (forgot spelling), we need to get our message out as patients and families of our rights to our own stem cells. This is the fight for this forum, a voice for all of us to be heard. I am sure you agree.
 

Donna

New member
http://www.factcheck.org/2012/01/the-state-of-obamas-facts/

Red Tape Reduction?

In other cases, the president’s factual claims checked out — but didn’t tell the whole story.

For example, Obama claimed he approved fewer regulations in his first three years in office than Republican President George W. Bush did three years into his first term. That’s true through Obama’s first 33 months in office — just barely. But Obama’s regulations came at a higher cost.

Obama: In fact, I’ve approved fewer regulations in the first three years of my presidency than my Republican predecessor did in his.

Obama is right, as far as his statement goes. Bloomberg News, based on a review of Office of Management and Budget data, reported that the Obama administration approved 613 regulations in the first 33 months. That was 30 fewer than Bush approved in his first 33 months.

However, Bloomberg also found that it cost more to comply with Obama’s regulations than either Bush’s or President Bill Clinton’s during that same time period.

Bloomberg News, Oct. 25, 2011: The number of significant federal rules, defined as those costing more than $100 million, has gone up under Obama, with 129 approved so far, compared with 90 for Bush, 115 for President Bill Clinton and 127 for the first President Bush over the same period in their first terms.

This is not the first time that the administration has hand-picked regulatory data to cast its actions in a more positive light than those of Obama’s Republican predecessor.

As we wrote in September, Cass Sunstein, administrator of the White House Office of Information and Regulatory Affairs, wrote an op-ed in the Washington Post to address Republican complaints of overregulation. In that opinion piece, Sunstein said the Bush administration proposed more costly regulations in its last two years than the Obama administration did in its first two years. That was true, but misleading. The fact is that Obama’s regulations in his first two years were far more costly than those of Bush’s first two years. And that’s the more relevant comparison.
 

LLL6521

Member
The interviewer, Rob Quirk of KOAA-TV, asked Obama what it would take to win reelection. Obama’s reponse: “...where Congress is not willing to act, we’re going to go ahead and do it ourselves.”

The President has empowered federal agencies and appointed Czars to make sure government can expedite his views and desired changes even if it means bypassing congress, hence, FDA's power hungry agenda to control the supplement market and autologouos stem cells as drugs. Bottom line, this happened under Obama's watch.
 

Connie

New member
I did not mean to start a political debate. I was just pointing out that neither of the choices in front of us are very appealing to ME. I was not trying to convince anyone to vote for either candidate. As an independent voter I am tired of having to vote for the one I fear least and it seems to me that it is getting harder and harder to decide which side that is.

Donna, I am quite aware of Governor Rick Perry and his beliefs since I am a Texan. I, like you, do not agree with him on many issues but I am very happy that he is pro Adult Stem Cells. As you know our Governor has had stem cell treatments himself. I do not wish pain or illness on anyone but if more politicians needed these treatments I believe the landscape would quickly change as it has in Texas. It is exciting that your friend was able to get treated here and I hope they have a wonderful outcome from that treatment. Unfortunately the price this group has set is much more than most people can afford and the FDA is already nipping at their heels trying to stop them.

LLL6521, Thank you for understanding where I was coming from. "I am sure Connie’s point about both sides has some truth to it with the facts of more and more regulations from wherever it’s from stalls our progress." I appreciate everything you say and I too wish for the America that our founding fathers dreamed of. I just don't believe we should have to choose between personal liberties and economic success. My fight right now is for the right to use my stem cells also, my life depends on it. I just don't think that we should have to disregard all of our other freedoms or trade them for this right. I want it all and I am not willing to sit by quietly while either side takes any of this away from us.

Barbara, I am shocked to hear you say that you want Adult Stem Cells to be included as an experimental DRUG. I thought this is what you had been helping Dr. Centeno fight against. I am not of the belief that we should have to give up one part of our body, or one age groups freedoms, for another. It should not be a "either or" deal. All of my body parts are mine and no part of my body should be considered a drug or be regulated by the government.
 

barbara

Pioneer Founding member
LLL6521 - I agree with you about the 60 Minutes piece. I was interviewed by Michael Rey, one of the producers, and told him that 60 Minutes needed to vet those like Dr. Kurtzberg. Unfortunately, it fell on deaf ears, but we will continue the fight to make the media more accountable.


Here's an interesting video that was sent to me today.

August 27, 2012
Republicans Are More Pro-Science Than Democrats

http://www.conservativevideos.com/2012/08/are-republicans-more-pro-science-than-democrats/
 

barbara

Pioneer Founding member
Connie stated:

Barbara, I am shocked to hear you say that you want Adult Stem Cells to be included as an experimental DRUG. I thought this is what you had been helping Dr. Centeno fight against. I am not of the belief that we should have to give up one part of our body, or one age groups freedoms, for another. It should not be a "either or" deal. All of my body parts are mine and no part of my body should be considered a drug or be regulated by the government.



Connie - I don't think you understood what I was meaning about being able to have stem cells included in Rand Paul's bill. Our stem cells are already regulated as drugs. That is fact. That is the reality we have to face for now. If the current administration stays in power, it is not likely to push for change of the regulations that the FDA has already put in place. Tagging stem cells onto the bill is a way that could give dying patients access to their own stem cells. My ultimate choice would be complete deregulation, but it's not likely to happen unless there is a change at the FDA or Dr. Centeno ultimately wins his lawsuit. How long will that take? I have no idea and I don't think anyone else does either. In the meantime, how many more people will die that might have been helped with stem cell therapy?

I don't plan to stop my fight for deregulation, but my main concern is getting access for patients who desperately need to have all options available to them.
 

LLL6521

Member
You are right Barb. Dr. Centeno is in the middle of an appeal, and then after all said and done, they may appeal for a second time. I still admire his will to fight, but this can take years. God bless Centeno!!! He is fighting for all of us.

Putting political partisanship aside, and focusing on the best options of having a change in policy towards stem cells, is finding a way to replace the current FDA Commissioner. No guarantee of immediate change once a replacement is found, however, this is our best foreseeable option in November.
 

barbara

Pioneer Founding member
There is some doubt as to whether it does cover stem cell treatments. On the surface it sounds like it does, however, it isn't spelled out clearly and some in the industry see that as a problem.


FDA Law Blog - Here's the latest

Congressional Interest in FDA Remains High, Even After the Enactment of FDASIA

Posted: 20 Aug 2012
By Kurt R. Karst –

Just before Congress recessed for the month of August, and less than a month after the July 9th enactment of the FDA Safety and Innovation Act, several FDA-related bills were placed in the hoppers in the U.S. Senate and U.S. House of Representatives. With an election on the horizon and several other non-FDA-related issues to handle, it seems highly unlikely that Congress will be poised to tackle the FDA bills this year; however, they may provide some insight into some of the issues that will be debated in the 113th Congress come 2013.

H.R. 6272 – The Trial and Experimental Studies Transparency (“TEST”) Act of 2012
According to a press release from the primary sponsor of the bill, Rep. Ed Markey (D-MA), the TEST Act would close certain “clinical trial loopholes and bring certainty and transparency to life-saving research studies.” Among other things, the bill would amend the definitions of “applicable device clinical trial” and “applicable drug clinical trial” at PHS Act § 402(j)(1)(A) to require that “all interventional biomedical studies on humans” be registered at ClinicalTrials.gov “before the first participant is enrolled in the trial.” Although current draft guidance on clinical study registration explains that certain studies conducted outside of the United States do not need to be reported on Clinicaltrials.gov, the TEST Act specifically applies to “any interventional study of a [drug or device] conducted outside of the United States the results of which are submitted to the Secretary in support of” a marketing application, including a PMA and 510(k) notification for devices, and an IND, NDA, BLA, or ANDA for drugs and biologics. (Applications for biosimilars under PHS Act § 351(k) are not specifically mentioned in the bill, but the broad reference to PHS Act § 351 presumably includes them.) An “interventional study” is defined in the bill to mean “a study in human beings in which individuals are assigned by an investigator, based on a protocol, to receive specific interventions to evaluate their effects on biomedical or health-related outcomes.” Support for the TEST Act has already appeared in the pages of The New England Journal of Medicine (see here).

H.R. 6288 – The Patient Choice Act of 2012
According to Rep. Brian Bilbray (R-CA), who introduced H.R. 6288 (see here), the bill is intended to “speed up the approval process of drugs used in therapies and treatments of patients fighting life threatening diseases.” It would do so by establishing a “provisional approval” system for a product designated by FDA as a “fast track” product under FDC Act § 506. (FDASIA made several amendment to FDC Act § 506 – see here.) In order for FDA to grant a request for provisional approval, the Agency would have to determine that a product is “adequately safe.” This term is defined in the bill to mean that “for at least one population, the risk of death or morbidity caused directly by an adverse effect of the drug, as determined in one or more safety studies or through other data that the Secretary determines are sufficient, is unlikely to be greater than the combined direct and secondary risks of death or morbidity, as established in the literature or historical data” of the target disease, among other things. The bill also contains provisions on the requirements for products granted provisional approval, and on the timing of the start of marketing exclusivity.

H.R. 6342 – The Compassionate Freedom of Choice Act of 2012
The Compassionate Freedom of Choice Act of 2012 was introduced by Rep. Ron Paul (R-TX) (see here) and is intended to allow the importation, distribution, and sale of investigational drugs and devices by terminally ill patients if their physicians certify: “(i) such patients have no other treatment options; and (ii) the patient executes written, informed consent that they are aware of any potential risks from the drug, device, or treatment.” According to one advocacy group, H.R. 6342 “would substantially limit FDA’s ability to second-guess treating physicians’ decisions concerning the standard and methods of care available to terminally ill patients.”

S. 3506 – The Ethical Pathway Act of 2012

S. 3506 was introduced by Sen. Bernie Sanders (I-VT) and is intended to “eliminate requirements to undertake duplicative clinical testing of new pharmaceutical drugs, vaccines, biological products or medical devices, when such duplication is inconsistent with relevant ethical norms” (e.g., the Declaration of Helsinki). To do this, the bill, if enacted, would require FDA to establish a mechanism by which an applicant may request a cost-sharing arrangement with the owner of existing regulatory test data. The bill is in line with other legislation introduced by Sen. Sanders to create a prize-based system for new drugs, instead of one with patent and non-patent exclusivity incentives (see here and here).
 
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