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FDA’s New Claim: “Your Body Is a Drug—and We Have the Authority to Regulate It!” | The Alliance for Natural Health USA

In BUSINESS OF STEM CELLS on March 21, 2012 at 4:27 am
FDA’s New Claim: “Your Body Is a Drug—and We Have the Authority to Regulate It!”

January 31, 2012

stem cellIn another outrageous power-grab, FDA says your own stem cells are drugs—and stem cell therapy is interstate commerce because it affects the bottom line of FDA-approved drugs in other states!

 

We wish this were a joke, but it’s the US Food and Drug Administration’s latest claim in its battle with a Colorado clinic over its Regenexx-C™ procedure, a non-surgical treatment for people suffering from moderate to severe joint or bone pain using adult stem cells.

The FDA asserts in a court document that it has the right to regulate the Centeno-Schultz Medical Clinic for two reasons:

  1. Stem cells are drugs and therefore fall within their jurisdiction. (The clinic argues that stem cell therapy is the practice of medicine and is therefore not within the FDA’s jurisdiction!)
  2. The clinic is engaging in interstate commerce and is therefore subject to FDA regulation because any part of the machine or procedure that originates outside Colorado becomes interstate commerce once it enters the state. Moreover, interstate commerce is substantially affected because individuals traveling to Colorado to have the Regenexx procedure would “depress the market for out-of-state drugs that are approved by FDA.”

 

We discussed the very ambiguous issue of interstate commerce last September—it’s an argument the FDA frequently uses when the basis for their claim is otherwise lacking. As we noted then, the FDA holds that an “interstate commerce” test must be applied to all steps in a product’s manufacture, packaging, and distribution. This means that if any ingredient or tool used in the procedure in question was purchased out of state, the FDA would in its view have jurisdiction, just as they would if the final product had traveled across state lines.

 

This time the FDA just nakedly says in court documents that the agency wants to protect the market for FDA-approved drugs. No more beating around the bush—their agenda is right out in the open! This appears to be a novel interpretation of the Food Drug and Cosmetic Act (FD&C), as evidenced by the government’s failure to cite any judicial precedent for their argument.

 

The implication of the FDA’s interpretation of the law, if upheld by the court, would mean that all food, drugs, devices, and biologic or cosmetic products would be subject to FDA jurisdiction. The FDA is expanding its reach even to commerce within the state, which we argue is far beyond its jurisdiction, in order to protect drug company profits.

 

Last year we ran a two-part series on the current status of federal and state law—and FDA jurisdiction—and how it affects integrative treatments (part one and part two).

 

The Centeno-Schultz Medical Clinic takes your blood and bone marrow, puts it into a centrifuge machine that separates the stem cells, and cultures it to get more cells before a doctor puts them back in your body to repair damaged tissue. The FDA states that when the stem cells are cultured, they become FDA-regulated drugs. The clinic has argued numerous times that stem cells aren’t drugs because they are components of the patient’s bone marrow from his or her own body.

 

The FDA says otherwise: “Stem cells, like other medical products that are intended to treat, cure, or prevent disease, generally require FDA approval before they can be marketed. At this time, there are no licensed stem cell treatments.” There they go again, saying that components of your body are drugs and they have the authority to regulate them! It’s the only way the agency can claim that adult stem cell therapy is within FDA’s purview.

 

However, the agency seems to be of two minds. When ESPN magazine was doing a story on stem cell treatments, the FDA stated that US policy is to allow the injection of stem cells that are treated with “minimal manipulation,” which federal regulations define as “processing that does not alter the relevant biological characteristics of cells or tissues”—which is certainly the case with the Regenexx same-day procedure.

 

Despite this policy, FDA has been attacking the clinic for the past four years. They have tried injunctions and demanded inspections in their attempts to make the company bend; this court battle is merely the latest salvo.

 

The primary role of adult stem cells in a living organism is to maintain and repair the tissue in which they are found. The hard part has been to get enough of them. But new technology is giving doctors the ability to obtain more stem cells from a patient than previously thought possible, which is why we’re now seeing new treatments. Blood, fat, or tissue is withdrawn from the patient, stem cells are obtained using one of these new processes, and the cells are injected back into the patient where they can repair the patient’s tissue.

 

Gov. Rick Perry received this kind of stem cell therapy. We and others noted that the governor’s defense of freedom of healthcare choice when it came to his own treatment was starkly at odds with his directive to administer HPV vaccines to young girls against their own (and their parents’) wishes. It’s also at odds with his support for some of the most egregious witch-hunters on the Texas State Medical Board, which he appoints.

 

 

 

Behind Perry’s blatant inconsistency and the latest FDA attempted power grab lies the same problem: a medical system run by special interests under the leadership of the US government, the same government that is supposed to represent “we the people.”

Editors’ Note: An earlier version of this article reported that when blood and bone marrow were put into a centrifuge to separate the stem cells, the FDA considered the stem cells to be a drug and claimed authority to regulate them. The article has been updated to reflect that FDA only claims authority to regulate as drugs those stem cells which are cultured before being re-injected into the body.

 

FDA’s New Claim: “Your Body Is a Drug—and We Have the Authority to Regulate It!” | The Alliance for Natural Health USA.

 

Related commentary: ABORTION, EMBRYONIC STEM CELLS, CRICHTON and PHARMA:
insidious analysis…i been around the block once or twice and traveled and listened enough to know that things are not always what they seem and the reasons for doing so are rarely what they appear.

women’s rights are getting squeezed and rung out of them like yesterday’s dirty sponge water and while this is a travesty in and of itself I can’t help but believe that this is the beginning of many more injustices and changes which will make our heads spin. is this an effort to establish that: your body is not your own? we no longer have the right to choose what we put in our body (from vaginal probes to GMOs so “my body/their property” seems closer than i care to admit…

For an absolutely chilling account of “My Bodies, Their Property” read this:

“Patenting lives: life patents, culture and development” Forfeited Consent: Body parts in Eminent Domain Page 95 http://books.google.com/books?id=3hFLooYJRIcC&printsec=frontcover
“Intellectual property, medicine and health: current debates” Property and Human Tissue Page 123 http://books.google.com/books?id=ZIaM8LXlGG0C&printsec=frontcover

Basically, if a woman is state or corporate property, then so is her fetal matter; so doctors can remove the biological materials and use it with legal backing? OR, if a woman is genetically resistant to a specific disease, maybe they can just claim her child and use it for testing?

more and more i see actions performed under the umbrella excuse “the good of the many outweighs the needs of the few” How long before the health of the many is worth the death of the one? perhaps this an embryonic stem cell angle? one last gasp of pharma to fool the public into carrying the embryonic stem cell torch despite the FACT that embryonic stem cell treatments don’t work and do cause tumors?

this isn’t out of the realm of reality, if you disbelieve, go read Mike Chrichton’s 2006 book NEXT – “…and that the physician’s university had sold the rights in Frank’s cells to BioGen, a biotechnology startup company. As the book opens Frank is suing the university for unauthorized misuse of his cells, but the trial judge rules that the cells were “waste” that the university could dispose of as it wished. Frank’s lawyers advise that, even if he wins an appeal, the university as a tax-funded organization can still claim the rights to the cells under the doctrine of eminent domain.”

The pharma company then goes after his kids since the genetic material is the same and if they own the father, the own the son (and the sins of the father shall be visited on the sons…the genetic commercial potential tool) M.C. said about this book: “This novel is fiction, except for the parts that aren’t.”

We’ll see…this goes in the category of “i hope i’m wrong but this twisting in my gut is telling me otherwise”

Cord Blood America Says Two Recent Financial Transactions Strengthen Company’s Balance Sheet

In BUSINESS OF STEM CELLS on August 6, 2010 at 12:55 pm

(OTCBB: CBAI – Cord Blood America, Inc.)

http://media.marketwire.com/attachments/200901/433220_MWUpload_CBAILogo.jpg

LATEST NEWS!! Cord Blood America Says Two Recent Financial Transactions Strengthen Company’s Balance Sheet

LAS VEGAS, Aug 05, 2010 — Cord Blood America, Inc. (OTC Bulletin Board: CBAI), the umbilical cord blood stem cell preservation company focused on bringing the life saving potential of stem cells, a biological insurance policy, to families nationwide and internationally, today said that it has had positive movement on two financial obligations that further strengthen its balance sheet.

The Company announced it has retired a $1.1 million debt obligation with JMJ Financial. “Eliminating debt and getting to cash flow positive are paramount to the long term success of CBAI,” said Matthew Schissler, co-founder and CEO. “We are laser focused on these two goals.” Also, in a Form 8-K filing, Cord Blood America announced, after extensive negotiations, it has canceled a 36 million share Warrant Agreement valued at $1.8 million with Shelter Island Opportunity Fund, LLP, and replaced it with a Senior Secured Note in the principal amount of $1,590,400.

“This obligation was under the derivative liability line on our balance sheet, and as a result, now gets paid down over the next 12 months, making our balance sheet stronger. We took 36 million warrants off the table. The obligation in total was reduced by over $300,000 by our calculations. Interest is only for 6 months and payable in cash. We believe reducing the principal and interest obligation, removing warrant overhang, reducing the derivative liability over the next 12 months are all good for shareholders,” said Matthew Schissler, co-founder and CEO. “It is important that our shareholders understand that we are continually working to improve our financial condition, as well as acquiring new businesses and diversifying our revenue stream.” About Cord Blood America Cord Blood America is the parent company of CorCell, which facilitates umbilical cord blood stem cell preservation for expectant parents and their children. Its mission is to be the most respected stem cell preservation company in the industry. Collected through a safe and non-invasive process, cord blood stem cells offer a powerful and potentially life-saving resource for treating a growing number of ailments, including cancer, leukemia, blood, and immune disorders. To find out more about Cord Blood America, Inc., visit our website at http://www.corcell.com/.

via www.StockMarketingInc.com: Stock Marketing Inc Presents!! ERFW,ADLS,ELRA,CBAI,VKNG,WSRA:: Sign Up With Us Today!! | TradingMarkets.com.

BRAINSTORM (ISRAEL) STEM CELL THERAPY TREATMENT READY FOR CLINICAL TRIALS

In BUSINESS OF STEM CELLS on November 15, 2009 at 11:30 pm

http://vancityguy.files.wordpress.com/2008/12/brainstorm.jpg?w=400&h=300

BrainStorm Cell Therapeutics Inc. (OTCBB:BCLI), a leading developer of adult stem cell technologies and therapeutics, is pleased to announce that its chief medical advisor, Professor Eldad Melamed, was interviewed on November 9, 2009 on Israel?s most popular radio broadcast, Galei Zahal. The interview was conducted by Yaron Willensky, a respected news talk show host, to discuss the latest achievements, treatment and progress of BrainStorm?s stem cell technology and therapy with respect to neurodegenerative diseases such as ALS and Parkinson?s disease.

?The stem cell therapy treatment is ready. We have successfully been able to process autologous adult human mesenchymal stem cells, grow them and differentiate them into other cell types for the treatment of neurodegenerative diseases. We are currently in middle of obtaining approval to begin the first clinical trials on ALS patients in Israel,? stated Professor Melamed during the interview. ?Regarding clinical trials for Parkinson?s disease, we are ready to begin,? continued Professor Melamed. ?However, we must still complete the regulatory approval process before that can happen.?

via PROFESSOR – BRAINSTORM CHIEF MEDICAL ADVISOR INTERVIEWED ON ISRAEL RADIO BROADCAST; STATES STEM CELL THERAPY TREATMENT READY FOR CLINICAL TRIALS :: UNTERNEHMENSNACHRICHTEN.

Geron’s Stem Cell Trial

In BUSINESS OF STEM CELLS on November 3, 2009 at 11:07 am

[For more articles on the long, sordid and somewhat pathetic history of Geron’s embryonic stem cell clinical trial to treat spinal cord injury, click here]

Spinal Cord Injury

Geron Corporation’s Stem Cell Trial

Monday November 2, 2009

Geron Corporation is a company based in Menlo Park, CA and the first biotech company in the USA to be granted permission for a clinical trial of regenerative medicine using embryonic stem cells, in humans. While permission was granted in January 2009, the trials were put on hold until last Friday (October 30, 2009) when the latest round of preclinical trials using animals revealed some side effects that warranted further investigation.

According to the Geron News Release, test animals receiving the treatment, GRNOPC1, developed a higher number of cysts at the area of spinal cord injury than in previous studies. However, the FDA has agreed to allow the studies to continue, since the cysts appear to be non-proliferative, confined to the injury site, and not associated with any serious adverse effects or SUSARS.

GRNOPC1 consists of human embryonic stem cell (hESC)-derived oligodendrocyte progenitor cells (OPCs). Oligodendrocytes are cells of the nervous system that produce the myelin shealth, which insultates the axons of nerve cells. Injection with the cells was shown to enhance remyelination of the spinal cord in adult rats. Demyelination after spinal cord injury contributes to loss of neural function. Rats treated with GRNOPC1 seven days after injury exhibited substantially better recovery and improved locomotor ability.

Geron expects re-initiation of the clinical trial in late 2010. Since the treatment must be applied shortly after injury, anyone wanting to participate in a clinical trial must agree to injections within 7 to 14 days of spinal injury…

via Geron Corporation’s Stem Cell Trial.

BrainStorm Reschedule Webcast Audio Conference

In BUSINESS OF STEM CELLS on October 15, 2009 at 12:27 pm

NEW YORK & PETACH TIKVAH, Israel–(Business Wire)– BrainStorm Cell Therapeutics Inc. (OTCBB:BCLI – News) , announced today that it will reschedule the webcast audio conference to update shareholders on its strategy and report on the way forward towards clinical trials. This event will be rescheduled for a later date to be announced soon. We apologize for any inconvenience.

via BrainStorm Announces That It Will Reschedule Its Webcast Audio Conference | Reuters.

http://www.clipartheaven.com/clipart/business_&_office/cartoons_(a_-_c)/brainstorm.gif

Aastrom requests delisting extension

In BUSINESS OF STEM CELLS on October 8, 2009 at 3:19 pm

Aastrom Biosciences Inc. will request hearing to avoid Nasdaq delisting – By Gabe Nelson

http://www.aastrom.com/images/AboutUs_4-09.gif

Aastrom is a leader in regenerative medicine developing autologous cell products for the treatment of chronic cardiovascular diseases.

Ann Arbor-based Aastrom Biosciences Inc. (Nasdaq: ASTM) is in danger of being removed from the Nasdaq Stock Exchange because the company’s stock price has remained below the listing threshold of $1, the company said today.

Aastrom plans to request a hearing with Nasdaq by Oct. 13 to request an extension, according to a statement.

Aastrom produces stem cell-based therapeutics to repair human tissue. The stem cells, grown from a patient’s bone marrow, are used to treat conditions such as chronic cardiovascular diseases.

The company first faced delisting in December 2007 and received a 180-day extension the following June.

Though Aastrom’s stock price stayed below $1, the company remained listed because of a temporary change to Nasdaq policy. The exchange suspended threshold requirements from last October until this July because so many companies saw their stock fall below $1 during the recession.

The most recent extension, granted in July, gave Aastrom until Oct. 1.

The exchange could choose to grant Aastrom an additional 180 days, or until March 31, 2010, to meet listing criteria.

The company’s stock price would need to close at $1 or above for 10 consecutive days of trading.

It opened Wednesday at 42 cents.

via Aastrom Biosciences Inc. will request hearing to avoid Nasdaq delisting – Detroit News and Information – Crain’s Detroit Business.

TOP STEM CELL STOCK NEWS TODAY

In BUSINESS OF STEM CELLS on September 28, 2009 at 4:04 pm

SWVL, EVFL, GOIG, SCII, September 28 Stocks to Watch from otcpicks.com

Emailwire - ‎7 hours ago‎
Stem Cell Therapy International, Inc., through its wholly owned subsidiary, Stem Cell Therapy International Corp., engages in licensing of stem cell

Not knowing what’s ahead, we look to futurists to help figure it out

Philadelphia Inquirer - Carol M. Ostrom – ‎6 hours ago‎
Dr. Chuck Murry, a University of Washington researcher who works with heart muscles and stem cells, doesn’t call himself a futurist, but adds: “I think we

Merkel wins German election

Nature.com (subscription) - ‎9 hours ago‎
[The Free Democrats] have a distinctly liberal approach in hot-button areas such as genetically modified crops and stem cells. … If the Free Democrats,

2009 Annual Financial Report

Sydney Morning Herald - ‎11 hours ago‎
Biocell was subsequently renamed Australian Stem Cell Healthcare Pty Ltd and is now the largest private cord blood bank in Australia.

Primera Bioscience Research Inc. Announces 2009 Financing

PR-USA.net (press release) - ‎10 hours ago‎
The Corporation currently has one project which is to collaborate with and provide $300000 of funding for certain brain tumour and stem cell research being

Dr. Stockpick Announces Daily Stock Watch – GFGU, PWRM, SCII

World Stock Wire (press release) - ‎8 hours ago‎
Today’s alerts include: getfugu, Inc. (OTCBB: GFGU), Power3 Medical Products, Inc. (OTCBB: PWRM), and Stem Cell Therapy International, Inc. (OTCBB: SCII).

BUYINS.NET: Naked Short Web Site Announces DNE, OSIR, GBGD Have

Trading Markets (press release) - ‎5 hours ago‎

There is no longer a failure to deliver in shares of DNE Osiris Therapeutics, Inc. (NASDAQ: OSIR), a stem cell therapeutic company, develops products to

Advanced Cell Technology Announces Proxy Results | Reuters

In BUSINESS OF STEM CELLS on September 16, 2009 at 2:33 pm

WORCESTER, Mass.–(Business Wire)– Advanced Cell Technology, Inc. (Advanced Cell, ACT) (OTC: ACTC) announced today that shareholders have approved each proposal in the Company`s proxy statement dated August 5, 2009.

As a result, the 2005 Stock Incentive Plan has been amended to increase the total number of shares available for issuance and the certificate of incorporation has been amended to increase the authorized shares eligible for issuance by the Company.

“We are pleased that shareholders have elected to approve each of the proposals in the proxy, supporting the Company`s efforts to further develop its stem cell technology platform,” said William M. Caldwell IV, the Company`s Chairman and Chief Executive Officer.

“We remain focused on submitting an IND for the RPE program to the FDA for approval to commence a Phase I Clinical Trial prior to the end of the year.”

via Advanced Cell Technology Announces Proxy Results | Reuters.

Are you or a loved one interested in receiving stem cell treatment? For free treatment information, please fill out our treatment form or email don@repairstemcells.org and just put Therapy in the subject box.

GCKO,GVBP,NPDT,OGNG Wall Street News Alert

In BUSINESS OF STEM CELLS on September 14, 2009 at 11:06 am
NovaGen_Image01

GENova Biotherapeutics

GENova Biotherapeutics, Inc. (OTCBB: GVBP | Quote | Chart | News | PowerRating) up 17.8% on 39 million shares traded.

breast reconstructionOn Sept 10, 2009 GENova Biotherapeutics, Inc. a biotechnology company that identifies, acquires, and develops novel drug targets that disrupt the advance of life-threatening diseases, recently announced it has filed a patent for a potential blockbuster drug target that combats breast cancer. The target, Tetanolic acid, is a tailor-made lipid which induces cell death in breast cancer cells, thus curtailing development of the harmful cancer.

breast cancer cell

breast cancer cell

This novel approach – using proteins to stop cancer – is based on recent discoveries that indicate that most tumors are derived from a cancer stem cell. The technology behind Tetanolic acid involved identifying specific characteristics of these cancer stem cells and then tailoring a lipid (Tetanolic acid) that can identify these characteristics and then attack the malignant cells whilst leaving healthy cells intact. This tailor-made cancer treatment strategy is far superior to any existing therapies, as it terminates the cancer at the source, with no side effects, and no harm to surrounding healthy tissues.

chemotherapy

chemotherapy

“This target has tremendous market potential, as it can ultimately eliminate the need for surgery and chemotherapy,” says Aaron Whiteman for GENova.

Worldwide, breast cancer is the fifth most common cause of cancer death, and is the most common cancer (and cause of cancer death) in women. The demand for new and better treatments for the disease is as urgent as ever.

via GCKO,GVBP,NPDT,OGNG Wall Street News Alert: Stock on the Move: GCKO – September 10, 2009.

Pfizer – actual settlement document

In BUSINESS OF STEM CELLS on September 3, 2009 at 5:19 pm

Wow is this ugly!

http://www.usdoj.gov/usao/pae/News/Pr/2009/sep/pfizer_settlementagreement.pdf

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