Atlas Shrugged with Our Stem Cells

[LLL6521]

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]

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]

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/20...han-democrats/

[barbara]

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]

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.

[Connie]

I believe Rand's father Ron Paul"s bill HR6342 The Compassionate Freedom of Choice Act 2012 should cover us and it has already been introduced Aug. 2nd By Ron Paul.

I must add that Ron Paul is a TEXAN

http://paul.house.gov/index.php?opti...2001&Itemid=60

here is the press release:

http://emord.com/blawg/wp-content/up...Choice-Act.pdf

[barbara]

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).