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Stem Cells May Help Treat Heart Failure

In STEM CELLS IN THE NEWS on August 30, 2010 at 8:17 pm

Stem Cells May Help Treat Heart Failure

Study Shows Injection of Bone-Marrow Stem Cells May Extend Lives of Heart Failure Patients

By Charlene Laino

WebMD Health News

Reviewed by Laura J. Martin, MD

Aug. 30, 2010 (Stockholm, Sweden) — Giving people with chronic heart failure injections of their own bone-marrow stem cells appears to improve their heart function and extend their lives, new research suggests.

The benefits of the stem cell treatment were apparent within three months and persisted for the five years the patients were followed, says researcher Bodo-Eckehard Strauer, MD, of Heinrich Heine University in Dusseldorf, Germany.

This isn’t the first time doctors have reported that stem cells may help improve the health of people with heart failure or other heart conditions.

But the 391-patient study is one of the biggest tests to date of stem cell therapy for heart disease — and the first to show that the treatment cuts the risk of death in chronic heart failure, Strauer tells WebMD.

The treatment “has almost no risks and is effective when used on top of other treatments for chronic heart failure,” he says.

The findings were reported here at the European Society of Cardiology Congress.

Stem Cells and Scarred Heart Tissue

One major cause of heart failure occurs when the heart muscle becomes scarred and loses its ability to pump enough blood throughout the body, often after a massive heart attack.

“The hope is that by injecting stem cells into the scarred area, you will bring life back to that area and induce healthy muscle,” says American Heart Association spokeswoman Mariell Jessup, MD, medical director of the Penn Heart and Vascular Center at the University of Pennsylvania.

Stem cells are at an early stage of maturation and therefore have the potential to become many different types of cells, including those in the heart muscle.

Treatment With Stem Cells

In the study, bone marrow stem cells were taken from the area at the top of the patient’s pelvic bone. Then they were processed in the lab in such a way as to allow them to be injected into the scarred heart muscle.

Nearly five years after the study started, seven of the 191 patients who had the stem cell treatment had died vs. 32 of 200 patients who did not have the treatment — a substantial difference.

The stem cell treatment improved the heart’s ability to pump blood and restored blood flow to oxygen-starved heart muscle. Patients were able to exercise more. They also reported improved quality of life, Strauer says.

No patient experienced side effects, he says. All patients continued to receive optimal medical treatment throughout the study.

“There’s been ongoing excitement about using stem cells to treat heart disease for some time and this study certainly adds to it,” Jessup tells WebMD.

But the therapy is not ready for prime time, she says. One of the reasons: In the study, people knew whether they were getting the stem cell treatment, she says.

“It’s not like the traditional randomized, controlled trial where people don’t know whether they are getting the experimental treatment. That’s what we really need,” Jessup says.

Also, there may be “some increase in potentially life-threatening [irregular heartbeats]. You can’t discount that and say there are no risks,” she says.

This study was presented at a medical conference. The findings should be considered preliminary as they have not yet undergone the “peer review” process, in which outside experts scrutinize the data prior to publication in a medical journal.

via Stem Cells May Help Treat Heart Failure.

Marijuana Relieves Chronic Neuropathic Pain

In Medical Marijuana on August 30, 2010 at 7:49 pm

Submitted by Deborah Mitchell on 2010-08-30

Chronic neuropathic pain is difficult to treat, but a new study suggests that smoked marijuana (cannabis) is an effective therapy for this challenge. Scientists found that smoking marijuana reduces pain, improves mood, and helps sleep.

Marijuana as Medicine

Medical marijuana is often in the news, and while controversial for various reasons, study after study show that cannabis in various forms can be helpful in treating a variety of conditions. Recently (February 2010), researchers at California’s Center for Medicinal Cannabis Research reported study findings regarding the therapeutic benefits of smoking marijuana for treating pain-related conditions. The studies were the first ever conducted on the therapeutic value of smoked marijuana in the United States in more than two decades.

Spray marijuana also recently demonstrated effectiveness in reducing cancer pain, especially in patients who had not gotten relief from morphine or other medications. Six studies also showed that extracts of marijuana significantly reduced spasms in patients who have multiple sclerosis. Yet other research indicates that marijuana is beneficial in patients who have post-traumatic stress disorder, including returning war veterans.

via Marijuana Relieves Chronic Neuropathic Pain.

CTV Winnipeg- Smoking marijuana helps reduce pain, trial shows – CTV News

In Medical Marijuana on August 30, 2010 at 7:49 pm

Smoking marijuana helps reduce pain, trial shows

Smoking marijuana helps reduce pain, trial shows. (AP / Robert F. Bukaty)

Dr. Mark Ware, director of research at the Alan Edwards Pain Management Unit of the McGill University Health Centre speaks with CTV News from Montreal on Monday, Aug. 30, 2010.

Dr. Mark Ware, director of research at the Alan Edwards Pain Management Unit of the McGill University Health Centre speaks with CTV News from Montreal on Monday, Aug. 30, 2010.

Updated: Mon Aug. 30 2010 20:17:21

CTV.ca News Staff

Though many who suffer chronic pain will tell you that smoking pot can help dull the pain, there has been little hard medical research into whether it really is effective.

Now, a new randomized, placebo-controlled clinical trial, appearing in the Canadian Medical Association Journal, shows that marijuana really can bring pain relief and improved sleep to those in chronic pain.

Dr. Mark Ware, director of research at the Alan Edwards Pain Management Unit of the McGill University Health Centre, led a team who studied the pain-relieving effects of smoking cannabis in 21 people with “chronic neuropathic pain”: those who had constant nerve pain, caused by trauma or surgery.

All had suffered the pain for at least three months, had failed to get effective relief from other medications, and reported an average weekly pain intensity score greater than 4 on a 10-point scale.

To ensure that the participants couldn’t tell who was smoking real marijuana and who was smoking a placebo, the patients were given a special pipe and 25-milligram capsules of a substance to be lit and inhaled once. The capsules contained either 2.5 per cent, 6 per cent or 9.4 per cent tetrahydrocannabinol (THC), which is the active ingredient in marijuana. The placebo pill contained no THC.

They smoked the pipe three times daily for five days in each cycle, followed by a nine-day period without marijuana. They continued this over two months, rotating through all four strengths of THC.

The researchers found that those smoking the tabs with the highest potency, 9.4 per cent, saw their average pain “significantly reduced” compared with those smoking the placebo. The patients also reported improvements in sleep quality and anxiety.

Because the dosages were fairly small compared to what “recreational” pot smokers would receive, most participants said they didn’t get “high” from the drug; “euphoria” was reported on only three occasions.

The researchers note that off the one puff, the blood levels of THC in the study participants reached only about 45 nanograms per milliliter, whereas most pot smokers would see levels reach 100 ng/mL and higher.

“We used a small dose for two reasons,” Ware explained to CTV News Channel. “One was to reduce the likely effect on the lung; it was a smoked product after all, so we wanted minimize the possible effects on the lung and respiratory track.

“The second reason was to minimize the possible psychoactive effects. We were not using this as a way to get people high but to try to ameliorate a very devastating symptom of chronic neuropathic pain.”

Some of the patients did report side effects, including dizziness, numbness and a burning sensation in areas of neuropathic pain.

The researchers note that while cannabis has been used to treat pain since the third millennium B.C., the pain-relieving effects of the drug remain controversial in the medical community. Further study on whether the drug really works is needed, the researchers said, given that at least 10 per cent of patients with chronic non-cancer pain and other conditions have tried using marijuana to relieve pain.

The researchers say they would like to see larger and longer studies on marijuana, using higher potencies and flexible dosing to see if pain levels can be reduced even further.

“What I hope this study will do is highlight for patients and physicians that cannibinoids — the active ingredients in marijuana — are a legitimate contribution to pain management and should be considered as one option when you are trying to treat chronic pain,” Ware said.

Dr. Mark Ware, director of research at the Alan Edwards Pain Management Unit of the McGill University Health Centre speaks with CTV News from Montreal on Monday, Aug. 30, 2010.

In an accompanying editorial, Dr. Henry J. McQuay of Oxford University, notes that the results are important in light of the fact that patients interested in the pain relief offered by medical marijuana have seen only a “trickle” of evidence to prove the claims that the drug works.

via CTV Winnipeg- Smoking marijuana helps reduce pain, trial shows – CTV News.

High time to legalize marijuana? – Quincy, MA – The Patriot Ledger

In Medical Marijuana on August 29, 2010 at 4:28 pm

High time to legalize marijuana?

Byron Smith/The Enterprise

During a press conference Tuesday, Abington Deputy Police Chief Police Christopher J. Cutter shows bales of marijuana worth more than $1 million that was confiscated from a delivery truck.

By Amy Littlefield

Enterprise Staff Writer

Posted Aug 22, 2010 @ 06:00 AM

Last update Aug 23, 2010 @ 06:23 AM

BROCKTON —

Jean Augustin, 22, of Brockton, thinks using marijuana is OK, “as long as people don’t get too messed up or get into a car when under the influence of it.”

Dom Scolaro, 49, of Easton, used marijuana to ease the nausea from his cancer chemotherapy treatments. He says the Class D substance should be available to everyone, not just those who are sick.

“It’s the only thing that worked for me,” Scolaro said, “and I think it’s a crime that it isn’t legal.”

Forty percent of Americans say they have tried it, 73 percent want it legalized for medical use, but more than 800,000 people still get arrested each year for carrying it.

Despite a growing trend toward legalization of marijuana for both medical and recreational use, people are still arrested for using and carrying the drug.

Marijuana, also called grass and pot, entered the spotlight after last week’s arrest of Brockton photographer Tommy Colbert, who police allege tried to retrieve 700 pounds of marijuana from an Abington shipping facility. The pot was wrapped in Mexican newspapers and was worth $1 million on the street, police said.

While law enforcement authorities continue busting marijuana dealers, personal use is becoming more and more acceptable in mainstream culture.

Actress Meryl Streep, for example, is shown dragging on marijuana joints in the romantic comedy movie “It’s Complicated.” And before that film, the suburban housewife played by Mary Louise Parker was running a local marijuana business in TV’s “Weeds” show.

Rhode Island, California and 12 other states, plus Washington, D.C., have legalized marijuana for medical use, and a California ballot measure this year would make it legal for adults 21 and older to grow small amounts of pot for recreational use.

In 2008, Massachusetts reduced the penalty for possession of less than an ounce of marijuana to a ticket and a $100 fine. The Bay State joined 11 other states that already had decriminalization laws on the books.

Law enforcement officials acknowledge the state measure created a contradictory scenario.

“That (one ounce of) marijuana comes from 700-pound shipments – one’s legal and the other’s illegal.” said Raynham Police Chief Louis Pacheco. “How does that work? What’s the rationalization of that?”

“I think they should either make it legal or not legal,” he said.

A majority of voters in every community in The Enterprise coverage area supported the measure when it went before the voters two years ago.

Last week, according to a poll on The Enterprise website, 69 percent of those who participated supported having the state legalize marijuana and tax it as they do alcohol and cigarettes. The other 31 percent of readers oppose legalization, saying marijuana is a gateway drug.

Legalization advocates argue that law enforcement is wasting resources on a drug that doesn’t kill people.

In 2008, 847,863 people nationwide were charged with marijuana offenses, down slightly from 872,720 arrests in 2007. About 89 percent of the arrests were for possession, not for selling the drug.

“It’s a huge mis-allocation of resources,” said Mike Meno, communications director for the Washington, D.C.,-based Marijuana Policy Project. “Meanwhile, there are murders, and rapes and burglaries that are going unsolved.”

Mexican drug cartels reap about 60 percent of their profits in U.S. pot sales, taking in $8.6 billion in 2006 alone. As American pot-smokers fund the cartels, the U.S. government has spent billions fighting the unsuccessful Mexican drug war.

Mexican President Felipe Calderon said earlier this month that he would support a debate about legalization of all drugs as a way to address drug-related violence, which has killed more than 28,000 people since 2006.

Former Mexican President Vicente Fox later blogged his support for legalization.

“Radical prohibition strategies have never worked, he said.

Enterprise staff writer Amanda Reed contributed to this story. Amy Littlefield can be reached at alittlef@enterprisenews.com.

via High time to legalize marijuana? – Quincy, MA – The Patriot Ledger.

Cord Blood Wakes Up Drowning Victim’s Brain

In STEM CELLS IN THE NEWS on August 28, 2010 at 8:17 pm

Cord Blood Wakes Up Drowning Victim’s Brain

Stem cells from cord blood saves drowning victims brain. Exciting news for patients with brain trauma, cerebral palsy and stroke.

FOR IMMEDIATE RELEASE

PRLog (Press Release) – Aug 27, 2010 – New Heart Foundation is excited about reports of a patient’s cord blood stem cells treating her after a drowning accident left her with moderate to severe brain damage. Two year old Sparrow Morris drowned in her family’s pool and as a result lost oxygen for approximately 45 minutes and suffered 2 cardiac arrests. She was not expected to live. She did survive the drowning, but was left with significant brain damage. She was a two year old who functioned at the level of a 3 month old. Fortunately, her parents had stored her cord blood stem cells. A year after her accident Little Sparrow went to Duke University where she was treated with an infusion of her own cord blood stem cells. Within a day, her parents reported a dramatic improvement and she continues to improve. Her parents report she has not reached a plateau in her recovery since the stem cell treatment.

New Heart Foundation has patent pending protocols to treat stroke, cerebral palsy, brain trauma, and low oxygen injury to the brain similar to what affected baby Sparrow. The treatment involves adult stem cells.

Unfortunately, many patients suffer from these conditions. In addition, there is little in the way of available treatments for these conditions. United States statistics for these conditions include: Stroke: 6 million patients, Brain Trauma: 1.7 million, and Cerebral Palsy: 1million.

via Cord Blood Wakes Up Drowning Victim’s Brain.

Other STROKE articles:

  1. https://repairstemcell.wordpress.com/2010/09/21/autologous-neural-stem-cells-benefit-parkinson%e2%80%99s-patients-adultstemcell-com/
  2. https://repairstemcell.wordpress.com/2010/09/20/stem-cell-treatment-for-stroke-and-traumatic-brain-injury-wholewellness-net/
  3. http://www.scientificamerican.com/article.cfm?id=can-stem-cells-block-stroke-damage
  4. http://www.sciencedaily.com/releases/2011/08/110831160216.htm

Vendors, revellers gather at ‘Hempfest’ – UPI.com

In Medical Marijuana on August 26, 2010 at 4:28 pm

Vendors, revellers gather at ‘Hempfest’

Published: Aug. 22, 2010 at 1:28 PM

* Hempfest draws throngs to Seattle park

SEATTLE, Aug. 22 (UPI) — More than 150,000 people attended a “Hempfest” in Seattle to promote the use of marijuana as a medicinal product, a spokesman says.

The event also attracted about 100 vendors to Myrtle Edwards Park, Elliott Bay Park and Olympic Sculpture Park, The Seattle Times said Sunday.

Some came to listen to music, others to shop for clothing and other marijuana paraphernalia, and some just came to have a good time, the report said.

An advocacy group called Sensible Washington used the event to launch a campaign to pass a voter initiative to legalize marijuana in 2011. The group didn’t get enough signatures to make the 2010 ballot, the report said.

“We know marijuana is just a safe, benign, therapeutic substance,” said Douglas Hiatt, a medical-marijuana attorney and chairman of Sensible Washington.

A woman dressed as a purple cannabis fairy with elf ears handed out weed leis, while doctors spoke of the herb’s medicinal powers at a nearby ‘Hemposium,’ the report said.

Admission to the event was free, but organizers asked for a $10 donation to cover event costs estimated at $350,000.

via Vendors, revellers gather at ‘Hempfest’ – UPI.com.

Medical marijuana to fight cancer? | APP.com | Asbury Park Press

In ALL ARTICLES, Medical Marijuana on August 25, 2010 at 8:03 pm

Medical marijuana to fight cancer?

August 24, 2010

Q: I would like you to know about medical marijuana for cancer. In her late 30s, my wife was diagnosed with pancreatic cancer, stage 4a. It was a 6-centimeter tumor that had grown around the hepatic artery and portal vein.

At first I thought marijuana was just for nausea caused by her chemo, but then I found a study in the journal Cancer Research (July 1, 2006). It showed that cannabinoids specifically fight pancreatic tumor cells.

I changed her diet and started her on a regimen, and she is now cancer free. The regimen is being studied at the University of Wisconsin. I hope others can benefit from medical marijuana.

A: For years, marijuana research was suspected of being a way to rationalize people getting high. But as a recent article in Science News points out, scientists are now starting to take it seriously (June 19, 2010). The article you cite demonstrates that compounds from marijuana make pancreatic tumor cells commit suicide.

Other cancer researchers have followed up with studies on its effectiveness against a range of tumors in test tubes, including breast, colon, glioblastoma brain tumors and lymphoma, a blood cancer. None is yet in a clinical trial, but this will be an interesting field to watch. We are delighted your wife had such a good response to such a difficult-to-treat cancer.

via Medical marijuana to fight cancer? | APP.com | Asbury Park Press.

U.S. court rules against Obama’s stem cell policy | Reuters

In STEM CELLS IN THE NEWS on August 23, 2010 at 9:50 pm

A U.S. court ruled in favor of a law suit filed in June against the National Institutes of Health by researchers.   The preliminary injunction on Monday stops federal funding of human embryonic stem cell research under the position that “human embryonic stem cell research involved the destruction of human embryos.”  Christian groups also opposed to embryo research argued the NIH policy violated U.S. law and took funds from researchers seeking to work with adult stem cells.

While this ruling is based on moral issues and not scientific issues, there is a preponderance of evidence that scientifically, embryonic stem cells for treatment may prove to be a dead end for at least 20-50 years and adult stem cells are already proven safe and effective for treating over 130+ diseases in humans.  For more information on why adult stem cells are scientifically better suited for treating humans than embryonic stem cells, read these articles:

U.S. court rules against Obama’s stem cell policy

A microscopic view shows smooth muscle cells derived from human  embryonic stem cells showing the nuclei (blue) and proteins of the  cytoskeleton (green) in this handout photo released to Reuters by the  California Institute for Regenerative Medicine, March 9, 2009.  REUTERS/Alexey Terskikh/Burnham Institute for Medical  Research/California Institute for Regenerative Medicine/Handout

WASHINGTON | Mon Aug 23, 2010 6:22pm EDT

WASHINGTON (Reuters) – A U.S. district court issued a preliminary injunction on Monday stopping federal funding of human embryonic stem cell research, in a slap to the Obama administration’s new guidelines on the sensitive issue.

The court ruled in favor of a suit filed in June by researchers who said human embryonic stem cell research involved the destruction of human embryos.

Judge Royce Lamberth granted the injunction after finding the lawsuit would likely succeed because the guidelines violated law banning the use of federal funds to destroy human embryos.

“(Embryonic stem cell) research is clearly research in which an embryo is destroyed,” Lamberth wrote in a 15-page ruling. The Obama administration could appeal his decision or try to rewrite the guidelines to comply with U.S. law.

The suit against the National Institutes of Health, backed by some Christian groups opposed to embryo research, argued the NIH policy violated U.S. law and took funds from researchers seeking to work with adult stem cells.

The U.S. Department of Justice, White House and NIH had no immediate comment.

Key to the case is the so-called Dickey-Wicker Amendment, which Congress adds to budget legislation every year. It bans the use of federal funds to destroy human embryos.

That was not an issue for the NIH until the discovery of human embryonic stem cells in 1998. In 2001, then-President George W. Bush said he could only allow federal research money to pay for work done using a few batches, or lines, of the cells.

Many stem cell researchers objected, saying they could not do work needed to fulfill the promise of the powerful cells, which can give rise to all the tissues and cells in the human body. Privately funded researchers could do as they pleased, but federal funding is the cornerstone of such basic biological research.

NEW POLICY

As one of his first acts after taking office, Obama overturned that decision and the NIH set up a careful process for deciding which batches of human embryonic stem cells could be used by federally funded researchers.

The new guidelines do not allow the use of federal dollars to create the stem cells but do allow researchers to work with them if they are made by another lab.

Dr. James Sherley of Boston Biomedical Research Institute and Theresa Deisher of Washington-based AVM Biotechnology, who both work with adult stem cells, filed the original suit saying the guidelines would harm their work by increasing competition for limited federal funding. They both oppose the use of human embryonic stem cells.

Sherley was not immediately available for comment.

“There is no after-the-fact remedy for this injury because the Court cannot compensate plaintiffs for their lost opportunity to receive funds,” Lamberth wrote.

He found that the injunction would not seriously harm researchers who focus on human embryonic stem cells because it would preserve the status quo and not interfere with their ability to get private funding.

With the preliminary injunction in place, the two sides will likely present arguments and case history to the judge over whether the guidelines can be permanently blocked or be allowed to go into effect.

(Editing by Peter Cooney)

via U.S. court rules against Obama’s stem cell policy | Reuters.

State of pot: Who’s lining up for and against legalized marijuana – San Jose Mercury News

In Medical Marijuana on August 23, 2010 at 4:28 pm

State of pot: Who’s lining up for and against legalized marijuana

By Josh Richman, Oakland Tribune, Posted: 08/23/2010 12:00:00 AM PDT

# Oakland city council members Rebecca Kaplan, Jean Quan, Pat Kernighan, Larry Reid and Nancy Nadel and Oakland mayoral candidate Don Perata — Five of the council’s eight members (including mayoral candidates Kaplan and Quan) plus Perata believe legalization could be a tax revenue windfall for the cash-strapped city; the council voted July 20 to authorize up to four industrial-scale marijuana farming operations supplying medical dispensaries for now, but ahead of the curve if Prop. 19 passes.

n California Young Democrats — This official arm of the state Democratic Party represents voters 18 to 35, and “from the research that we’ve found, Prop. 19 is something they fully support,” CYD Communications Director Mike Kim said. CYD’s website says it’s “committed to creating a bloc of young voters who will elect Democrats for an entire generation.” Kim said “that wasn’t the fundamental reason as to why we voted ‘yes’ “… but we are very much aware this is an issue that’s going to bring out a lot of young voters to the ballots” hopefully to support the entire Democratic slate and agenda.

n Republican Liberty Caucus of California — The Ron Paul-following “Constitutional Republicans” say Prop. 19 is a proper limit on federal authority, leaving individuals to choose what they consume, but it opposes taxing marijuana cultivation and sales just as staunchly as it opposes all other taxation.

In California State Conference of the NAACP — PresidentAlice Huffman says the measure is a means of ending the “War on Drugs” that it says has disproportionately targeted and victimized young men of color for decades; at least one black religious group immediately called for Huffman’s resignation, saying she’s condoning the kind of drug use that has ravaged black communities.

n The American Civil Liberties Union’s California affiliates — Enforcement of marijuana prohibition consumes a great deal of California’s law enforcement and court system resources and has a disproportionate impact on communities of color, say the state’s three ACLU affiliates, with 96,000 members combined.

n United Food and Commercial Workers Western States Council — Representing 200,000 union members in Western states, including some 26,000 in California, the union sees this as an enhancement of the medical marijuana law that would create taxable revenue and jobs (union jobs, of course) in agriculture, health care, retail and possibly textiles while depriving drug traffickers of their income.

n Jeffrey Miron, senior lecturer and director of undergraduate studies at the Harvard University Department of Economics — The noted libertarian says legalization will reduce crime, reduce law enforcement costs, raise tax revenues and ensure quality control. “Just as the harms of alcohol prohibition were worse than the harms of alcohol itself, the adverse effects of marijuana prohibition are worse than the unwanted consequences of marijuana use,” he wrote.

Opposed:

n Major-party nominees for governor and state attorney general — Democratic gubernatorial nominee Jerry Brown and Republican gubernatorial nominee Meg Whitman won’t touch this one with the proverbial 10-foot pole: Both have come out against Prop. 19. The nominees for state attorney general — San Francisco District Attorney Kamala Harris, a Democrat, and Los Angeles District Attorney Steve Cooley, a Republican — co-authored a ballot argument rebuttal for the official state voters guide saying the measure compromises driving safety and threatens workplace safety and federal contracts. Politically, polls show pot legalization is a tough sell for statewide candidates, and nobody running to be the state’s chief executive or “top cop” wants to look “soft on crime.”

n U.S. Sen. Dianne Feinstein, D-Calif. — Arguably one of the state’s most influential Democrats, the lawmaker called this measure “a jumbled legal nightmare that will make our highways, our workplaces and our communities less safe,” leading to increased drug use, conflict with federal law and loss of federal funding.

n Law enforcement groups including the California Narcotics Officers Association, California Police Chiefs Association, the California State Sheriffs’ Association and the California District Attorneys Association and others. They say Prop. 19 is a threat to public health and safety and is likely to lead to more drug-related crime; critics say they’re trying to protect a failed “War on Drugs” model as well as their jobs.

n Mothers Against Drunk Driving — The group worries legalization will result in more impaired driving and thus more injuries and fatalities.

n Dennis Peron — A guiding force behind California’s medical marijuana law who says he was fired by Prop. 19 co-author Richard Lee’s Oaksterdam University because of his opposition to the measure, Peron, of San Francisco, feels the measure is too tough on marijuana. Limiting people to an ounce or 25 square feet of growing space is like limiting wine collectors to one bottle; taxation would be disproportionate and unfair; and prison terms for teens who toke or parents who smoke in front of their kids are excessive, he says.

n California Chamber of Commerce — The state’s biggest business group says legalization would “drive up costs and significantly undermine the ability of employers to protect the safety of all employees in the workplace” because employers, including the state, would have to prove a worker testing positive for marijuana is actually impaired from performing a job before disciplining or firing him or her. The chamber also says employers could lose public contracts and grants because they could no longer effectively enforce drug-free workplace requirements outlined by the federal government.

n California League of Cities — President Robin Lowe, a Hemet city councilwoman, said the League’s board recognizes “that the public safety risks far outweigh the potential for local revenue gain.”

Neutral:

n California Democratic Party — Despite support for endorsement from Chairman John Burton and liberals mobilized by the online progressive Courage Campaign, the party’s executive board chose July 18 to remain neutral, seemingly unwilling to cross anti-marijuana voters outside the state’s Democratic urban strongholds — and perhaps unwilling to let Republicans continue saying Democrats need drugs to get voters to the polls.

n California Labor Federation — Unions touting the job growth and tax revenue benefits were canceled out at the federation’s convention by others worried about public safety, implementation and federal legal issues. An endorsement would have meant all the federation’s affiliated unions would be tapped to support the measure via direct mail, phone banks, precinct walks and member-to-member outreach, and a vote to oppose would have blocked unions that like the measure from acting to support it. Neutrality lets each union decide whether and how to get involved, without compromising labor’s unity on other measures and candidates.

via State of pot: Who’s lining up for and against legalized marijuana – San Jose Mercury News.

FDA vs Adult Stem Cells – another view

In STEM CELLS IN THE NEWS on August 17, 2010 at 6:24 pm

More ObamaCare Cutbacks: Denver Clinic Must Stop Stem Cell Treatments

August 17, 2010

in Featured Image,Health Care Reform

August 17, 2010:  More ObamaCare Cutbacks:  Denver Pain Clinic Told to Stop Treatments
Obamacare has landed in Denver, where doctors at a pain-management clinic have been told they must stop treating patients with a successful process that extracts their own adult stem cells, cultivates them and then reinjects them to stimulate growth in damaged limbs. The word of the dispute comes from Dr. Christopher Centano of the Centano Schultz clinic, whose Regenexx, or Regenerative Sciences Inc., has been successfully treating patients with the process for several years.

Centano confirms his work provides a much less costly and significantly more convenient alternative to knee or hip joint replacement surgeries, which sometimes require a year or more of recuperation.

But the Food and Drug Administration, in the wake of the adoption of President Obama’s plan to nationalize health-care decision making, has ordered the company to halt, because the federal agency views the process as making “drugs.”

The FDA announced Aug. 6 that it wanted an injunction in federal court against the company, alleging “violations of current good manufacturing practice.”

“Regenerative Sciences’ cultured cell product is not approved by the FDA, and no adequate and well-controlled studies have been done to demonstrate its safety or effectiveness for any indication,” the federal agency announced.

Karen Midthun, acting director for the FDA’s Center for Biologics Evaluation and Research, said in the announcement, “FDA recognizes the importance of the development of novel and promising new therapies. However, when companies like Regenerative Sciences fail to comply with FDA laws and regulations, they put the public’s health at risk.”

An FDA spokeswoman provided the announcement to WND but did not elaborate.

The agency, in a 2008 letter to the company, said, “In order to introduce or deliver for introduction a drug that is also a biological product into interstate commerce, a valid biologics license must be in effect. Such licenses are issued only after a showing of safety and efficacy for the product’s intended use. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug application in effect as specified by FDA regulations. … The mesenchymal stem cells utilized in your Regenexx™ procedure are not the subject of an approved biologics license application (BLA) nor is there an investigational new drug application (IND) in effect. Therefore, your implantation of the mesenchymal stem cells for which a valid license or IND is not in effect appears to violate the Act and the PHS Act and may result in FDA seeking relief as provided by law.”

Centano told WND that despite the company’s repeated efforts to obtain a resolution in the disagreement, the FDA continually declined to respond – until Obamacare was adopted.

Now the federal agency has moved to “enjoin” the company’s operations, and Centano told WND his company will fight.

“I think what we’re seeing is a massive federalist move here,” he told WND. “I think this represents that [for] Obamacare to work there has to be strict federal control over medicine.”

A video has been posted in which Centano describes his work:

To see the video: http://www.youtube.com/watch?v=1qpkxK89T7U&feature=player_embedded

He said that until now, medicine has been provided by doctors and regulated at the state level.

“That’s not going to work under Obamacare,” he said. “The government is trying to get more and more positive control over what your doctor does or doesn’t do.”

Centano said the process he uses doesn’t create a drug, as the FDA claims. It’s not more complicated than the “blood-doping” process that athletes sometimes in the past have attempted to improve their performance.

And under the guidance offered by the FDA, a doctor who treats knee pain with a steroid and a painkiller should go through the process of acknowledging he or she is making a “drug” because of the combination of medications, he suggested.

In fact, labs that do in vitro fertilization “do pretty much identical to what we were doing in our lab.”

This, he said, is what “all physicians, regardless of what they do, can expect if the FDA has authority over the practice of medicine.”

“This is opening a Pandora’s box that will never be closed,” he warned. “It means that some bureaucrat sitting in Maryland has the ability to tell the doctor what he can and can’t do to you.

“The FDA action here clearly is an infringement of states’ rights; it infringes on the doctor-patient relationship. In order to make Obamacare work, there’s going to have to be a lot of infringement. They cannot control costs without it,” he said.

Centano explained the process his clinic has used: Stem cells are extracted from the back of the hip, they are isolated in the lab and cultivated to obtain a bigger number. They then are injected into the knee as an alternative for knee replacement surgery.

The doctor said only 4 percent of his patients end up eventually having knee replacement surgery after his treatments, leaving more than nine of 10 able to avoid the surgical costs, hospitalization costs and dangers, rehabilitation time and costs and pain of a joint replacement.

“Many of our patients are self-employed,” Centano said. “They just cannot afford a knee replacement and to take three to six months off work.”

The company also points out that stem cells from the body can be regenerated and reinjected to treat heart disease, COPD and other auto immune diseases.

He said that he’s looking forward to getting the case into court.

“The FDA will finally answer our questions, in court, about their claims and jurisdiction as opposed to doing everything in their power to avoid the issue that we are not a drug manufacturer, but simply a medical practice,” he said.

The clinic has been using its patients’ stem cells to treat orthopedic conditions since 2005 and first got a letter from the FDA in 2008 claiming its medical procedure was creating a new biologic drug. The FDA inspected Regenerative Science’s facility in 2009 and found, at that time, it was not compliant with drug mass manufacture guidelines but failed to take any action.

In the meantime, Regenerative Sciences had filed several lawsuits against the FDA to resolve the issue. It most recently has sought a temporary restraining order demanding the agency take “final” action or leave the medical clinic alone.

Adult stem cells are found throughout a patient’s body. Medical studies increasingly are indicating they have as much – or more – clinical promise than the controversial embryonic stem cells, which are derived from embryos that must be destroyed in the process.

Yet the Obama administration has been on a headlong pursuit to fund research using embryonic cells, while cracking down through the FDA on adult stem cell processes that work, he noted.

Customers, however, are thoroughly behind Centano’s work.

“I want the whole world – especially seniors – to know that injuries such as femoral, hip and pelvic fractures don’t have to diminish your quality of life,” wrote patient “J.A.” on behalf of the company. “You can be healthy and moving forward again with this procedure.”

While a long list of lawsuits are pending against Obamacare, most challenging its underlying constitutionality and seeking to cancel the entire concept, WND also has reported that more than three-quarters of the needed members of the U.S. House of Representatives have signed on to a measure to have a new vote on Obamacare that essentially would allow the chamber to withdraw its approval of the law and begin the process of banishing it.

August 16, 2010:  Obama Death Panel Doctor Cuts Treatment for Ovarian Cancer
Dr.  Donald Berwick , the death panel doctor approved by President Obama in a recess appointment without the approval of Congress now begins his sordid work.  This will kill women, pure and simple.
“Obama Stopping Some Drugs for Ovarian Cancer Patients”
Written by CA Political News on August 15, 2010, 02:00 PM
Ovarian Cancer National Alliance and Susan G. Komen for the Cure Appeal to FDA and Key Lawmakers on Avastin Issue

Ovarian Cancer National Alliance, 8/12/10

Washington D.C. August 12, 2010.
The Ovarian Cancer National Alliance (OCNA) and Susan G. Komen for the Cure today urged the U.S. Food and Drug Administration to continue to allow the use of the drug bevacizumab, commonly known as Avastin, for metastatic breast cancer patients, noting that it is effective for many individuals.
In a joint letter sent to the FDA and key Congressional lawmakers Thursday, OCNA and Komen for the Cure wrote we are particularly concerned about patients who are presently receiving bevacizumab and the message that this decision sends about drug development for women with advanced breast cancer.
OCNA is concerned that an FDA label change will further restrict access to Avastin for ovarian cancer patients. Many women with ovarian cancer are receiving and benefitting from Avastin, although its use for ovarian cancer is off label. These women face another worry: Medicare has already rejected some requests for Avastin, one of the worlds most expensive but widely used cancer drugs. OCNA argues that Medicare and its contractors should pay for anti-cancer drugs that are listed on the approved compendia for Avastin.
There is a fundamental fairness problem when the law is not being enforced equally, says Karen Orloff Kaplan, CEO of the Ovarian Cancer National Alliance. Medicare is obliged to pay for the costs of off label anti-cancer drugs listed on the approved compendia. We are concerned that a label change may create another barrier for treatment.
Many doctors report patients taking Avastin enjoy better than modest results according to the joint OCNA-Komen letter to the FDA. In addition, a large scale Phase III trial showed an increase in progression free survival in women who used Avastin in combination with chemotherapy and as maintenance therapy for ovarian cancer.
The decision to use Avastin should be made between a woman and her doctor after a thoughtful conversation that carefully considers its benefits and risks. OCNA believes that women who have the potential to benefit from this drug should have access to it.
The Ovarian Cancer National Alliance is the foremost advocate for women with ovarian cancer in the United States. To advance the interests of women with ovarian cancer, the organization advocates at a national level for increases in research funding for the development of an early detection test, improved health care practices, and life-saving treatment protocols.  The Ovarian Cancer National Alliance educates health care professionals and raises public awareness of the signs and symptoms of ovarian cancer. The Ovarian Cancer National Alliance is a 501 (c) (3) organization established in 1997.

via More ObamaCare Cutbacks: Denver Clinic Must Stop Stem Cell Treatments.

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