The Food and Drug Administration has telephoned Geron (just a phone call!) to tell them they may not proceed with their stem cell trials: that the paralysis treatment that was to have been tried on people—the world's first human trials with embryonic stem cells!--has once more been delayed.


Let's back up a little.


First, as you know, the FDA is a government agency, with the power to say yes or no to human trials of new medicines, products, and therapies.


If they said yes to Geron, the corporation would offer special stem cells (oligodendrocytes, made from human embryonic stem cells, from the Presidentially- approved stem cell lines) to about forty newly-paralyzed people. The cells would hopefully re-insulate (remyelinate) damaged nerves in the patient's injured spine, and possibly alleviate the horrific condition.


The potential treatment was pioneered by Dr. Hans Keirstead, originally funded by the Roman Reed Spinal Cord Injury Research Act. It became real for me on March 1, 2002 , at the University of California at Irvine . On that day, I held in my hand a laboratory rat which had been paralyzed, but which now walked again—and this while my paralyzed son sat in his wheelchair, a few feet away.


This first Geron treatment would only affect newly paralyzed people, whose injury was in the "acute" stage, just hours after the accident. It would not help my son, or any other person with a "chronic", or older injury.


But what a tremendous step forward it would be, to ease a condition long considered incurable.


Geron would be paying for the human trials, putting nearly the entire net worth of their company behind embryonic stem cell therapies. They and Dr. Keirstead worked closely with the FDA, following its instructions, determined nothing should be overlooked.


Then came the first official hearings: April 10th, 2008 .


The hearings, it seemed to me, were politicized: in my view, the people in charge did not seem to want the trials to go forward, and were looking for excuses to stop it. (I wrote two previous columns on which can be found in the archive sections of Karen Miner's and my website, www.stemcellbattles .com/archives:



#436 Friday, April 25, 2008
FDA STEM CELL HEARINGS POLITICIZED?


#439 Tuesday, May 6, 2008
THE DREAM, OR THE NIGHTMARE: Stem Cell Crisis Approaching?


I also spoke at the Independent Citizens Oversight Committee, voicing those concerns.


ICOC Chair Bob Klein expressed concern: that the FDA might put in a condition that embryonic stem cell trials might only be allowed for dying patients. This would be a disaster, meaning that human trials for embryonic stem cells to heal blindness as well as paralysis could not go forward, for example. He asked for volunteers on the board to be on a special FDA committee. Board members Jeff Sheehy and Leesa Gibbons volunteered for the chore!


But the overall response from almost everyone (and these are supporters of the research, good people, whose opinions I respect) was that the situation would be handled on the basis of scientific merit, and the safety of the patients, nothing more. Again and again people said, no, no, everything is fine, don't worry.


But I do worry. It seemed to me that the people on the FDA committee were adult stem cell research supporters, and that we were up against a stacked deck.

What if the committee had already decided not to let the human trials to go forward, because of political considerations?


As I see it, the Bush Administration is firmly opposed to embryonic stem cell research, and would gladly block it.


Whether the FDA was independent of politics, I had no way of knowing.


And then, the other shoe dropped.


The FDA telephoned Geron and told them the trials were "on hold": blocked. Why? For how long? We are not told.


Here is part of Geron's official press release.


"…the company received verbal notice today from the FDA that the company's…cell therapy for spinal cord injury…has been placed on clinical hold… an order that the FDA issues to a sponsor to delay a proposed trial or to suspend an ongoing investigation.


"We have not yet received a letter from the FDA explaining the decision to place the submission on hold, so we are unable to comment specifically, " said Thomas Okarma, Ph.D, M.D., Geron's president and chief executive officer. "Once we have the letter and have had a discussion with the agency, we will communicate our findings…We are disappointed with this action given the interactions we had with the FDA over four years leading to the filing, and the breadth and depth of the submission, some 21,000 pages, predicated on those discussions with the agency."… (for more information, visit www.geron.com)


What does this mean?


The delay could be completely innocent: a need for more clarification, a misunderstanding, the simple lack of time (the FDA is chronically underpaid and understaffed) . It could be a legitimate concern for safety.


Or it could be politics.


I called up Dr. Okarma, and asked him what he thought. He repeated what had been said above, but added that we should know in two to three weeks.


That is how long it should take for the FDA's letter to be transmitted to Geron.


Then we will know the reasons for the delay.


Maybe there will be sensible reasons.


And if not? If the bar for approval is set inappropriately high, if unfair conditions are attached, so the chance for progress is delayed or denied?


Then, folks, it is the advocates' hour.


If the FDA letter shows signs of being a political attack: our duty is clear.


In every state across the land, advocates must lead.


We will need every group to respond, and not just their boards, but their membership: every advocate will need to write letters and make phone calls to the media, and to our elected officials.


Politics must not deny good health to our families, and that means the best research must be allowed to go forward, untrammeled by political restrictions.


I was on a phone conference with CAMR (the Coalition for the Advancement of Medical Research) yesterday, and I raised the issue, and one member said:


"CAMR will probably not take part in a decision affecting a private company—unless there seem to be political attacks on embryonic stem cell research."


Which is precisely my point.


Political attacks on embryonic stem cell research cannot be allowed in the Food and Drug Administration; these folks must be above political maneuverings.


If the process has been interfered with by ideology, we must act.


So what do we do now?


We get ready.


May I suggest you consider contacting your friends, telling them to prepare for a major policy offensive?


When that letter from the FDA is released, its contents must be studied, carefully, by every patient advocate (leadership or not) in the country.


And if it is bad news, unfair conditions imposed to block progress, then we do everything in our power to rouse the country.


We will need to make this the biggest news story around.


Every media outlet can and should be contacted.


Editorial boards of newspapers should be approached, both in person, and by letter writing.


People in wheelchairs must speak and be seen on every television channel.


Voices never heard before must emanate from every radio station.


Because this is not just about paralysis.


This is for everyone-- and the fight must come from everyone as well.


Neither age nor condition must disqualify our involvement. So many times I have been told by champion advocates: "I am too old for cure to come for me; this is for my grandchildren, so they will not have to go through what I have endured."


Whether an advocate fights from a wheelchair or hospital bed, from a student's desk or a homemaker's kitchen, they—we—are striking a blow, not just for ourselves, but for our families, and our loved ones, healthy or not.


One hundred million Americans suffer disease or disability which stem cell research may one day alleviate, or cure.


If we speak as one, we can never be ignored again.


Don Reed

www.stemcellbattles .com

Campaigners have welcomed a prediction that stem cell treatment could be used to help reverse the effects of multiple sclerosis within 15 years.

The treatment could be used to halt the decline of patients suffering from the debilitating nerve condition.

Dr Laura Bell, of the MS Society, said: "These are exciting times for MS research. Ten years ago there were no drugs to treat MS, but today there are a range of therapies available and a dozen more in late stage clinical trials."

She continued: "We're putting millions into MS research and very much hope that the new avenues we are exploring - including stem cells - will bring about major advances in the next ten years."

Professor ffrench-Constant, director of a groundbreaking MS research centre in Edinburgh, told The Herald newspaper that stem cells could be used to help repair nerve damage caused by MS.

He said he wanted to find a way to make the body rebuild myelin - the sheath which protects nerve fibres - using stem cells, which have the ability to turn into different types of tissue. At present, medicines can only help reduce the inflammation which causes MS.

Prof ffrench-Constant added: "My vision for a patient coming into a clinic in ten or maybe 15 years' time is they will be given a mixture of drugs to prevent the inflammation and to promote repair. That way, MS would no longer be a chronic, disabling disease."

He added that he wanted to find ways of using stem cells already present in the brain to make new myelin.

The MS research centre is part of the Scottish Centre for Regenerative Medicine at Edinburgh University. It was launched thanks to a major donation from Harry Potter author, JK Rowling, whose mother died from the condition.

MS affects an estimated 85,000 people in the UK.
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Canada became the first country to adopt a system regulating the medicinal use of marijuana in July 2001.

The change came after an Ontario judge ordered the federal government to clarify the rules surrounding medical marijuana last summer.

The Ontario court said that by making marijuana illegal across the board, Canada's Controlled Drugs and Substances Act violated the Charter of Rights and Freedoms.

Now patients who meet Health Canada's regulations can legally smoke marijuana to ease their pain.


Terry Parker

The ruling came from a case involving 44-year-old Terrence Parker, an epileptic who says the drug is the only way to control his seizures. He smokes as many as four marijuana cigarettes a day.

In 1996, Parker was arrested for possession, cultivation, and trafficking. Police had raided his home and seized more than 70 marijuana plants.

Parker had been arrested for possession of marijuana before. In 1987, he even won an acquittal after proving his medical need but was told he would be prosecuted if he were caught with marijuana again. And he was, many times.

But the 1996 charges were different. This time Parker used the defence that the charges violated his rights under the Charter.

The argument worked and, on Dec. 10, 1997, the judge ruled people must be able to access necessary medical treatment without fear of arrest. The possession and cultivation charges were dropped and Parker became the first Canadian to be exempted from further prosecution for either charge.

(Parker was convicted of trafficking because he had openly stated to police that he occasionally gave marijuana to other people who needed it for medical reasons, though he was given probation instead of a jail sentence.)

The Ontario Court of Appeal's ruling upheld the lower court's decision.

In the ruling, Judge Marc Rosenberg wrote "I have concluded that the trial judge was right in finding that Parker needs marijuana to control the symptoms of his epilepsy" and that "forcing Parker to choose between his health and imprisonment violates his right to liberty and security of the person."

A woman smokes marijuana for medical reasons

About 300 people have been exempted from Canada's marijuana possession laws.

However, there are no guidelines on how these people are supposed to get the illegal substance. This leaves individuals in a constant battle with police who are just doing their job.

In April 2000, Catherine Devries of Kitchener, Ontario had ordered marijuana from the Compassion Club, a group in B.C. that provides marijuana for medicinal use. But her order was seized in the mail by police.

The police didn't realize Devries was one of the few people legally allowed to have marijuana, but it was too late. Giving it to her would be trafficking, a clear violation of Canada's drug laws.

That's one of the problems Ottawa hopes to solve.

In April 2001, the federal government released its proposed solution for the marijuana issue – a plan that would allow people suffering from terminal illnesses or severe chronic diseases, such as epilepsy and arthritis, to use the drug if it eases their symptoms.

Under the proposal, users will have to prove marijuana is their only option.

An underground greenhouse

On the issue of supply, some people would be able to grow marijuana themselves, as long as they follow strict guidelines including restrictions on the number of indoor and outdoor plants they can grow.

Those who can't grow marijuana themselves would be allowed to buy it from companies licensed by the government.

Health Canada plans to release a manual for physicians to accompany the new regulations.

In December 2000, Ottawa awarded Prairie Plant Systems, a Saskatoon company, the first licence to grow marijuana for research purposes. The company will be paid more than $5 million over five years to provide Health Canada with a reliable source of marijuana to meet the country's medical and research needs.

The government-supplied marijuana is being grown underground in an old mine in Manitoba.

Health Canada is also sponsoring a nation-wide clinical trial to study whether smoking marijuana provides relief for those with chronic pain.

On Jan. 9, 2003, the Superior Court of Ontario declared that the federal government's medical marijuana access regulations were unconstitutional because they failed to provide a legal supply of the drug. The court gave Ottawa six months to respond.

On July 9, 2003, the federal government put in place an interim policy to provide dried marijuana or seeds to Canadians authorized to take the drug for medical purposes.

Under the policy, marijuana will cost patients $5 per gram or $20 for a package of 30 seeds. The price is based on the cost to produce and distribute, but does not take into the costs of developing a safe and consistent product. Illegal marijuana is sold for $10-$25 per gram, according to Health Canada.

Cindy Cripps-Prawak

Health Canada spokesperson Cindy Cripps-Prawak said there was a good supply of medical marijuana in storage. She says Ottawa has about 370 kilograms of marijuana, 50 kilograms of which is packaged and ready to ship out. How often and how much of the drug patients get will depend on the individual. Dried marijuana will be provided in 30-gram bags, at a cost of $150 each. (A marijuana cigarette contains from half a gram to a gram of pot.)

The marijuana produced by Ottawa's supplier, Prairie Plant Systems, has a concentration of approximately 10 per cent THC (Tetrahydrocannabinol), the active ingredient in marijuana.

As of July 9, 582 Canadians were authorized to possess marijuana for medical reasons, most of whom were also licensed to cultivate the drug. Since the medical marijuana access regulations came into effect, Ottawa has received 1,145 applications (at a rate of 35-50 applications per month) from people wanting to legally smoke pot for medical reasons.

The interim policy was put in place pending Ottawa's appeal of the Ontario court decision, which is expected to be heard at the end of July 2003.

Health Canada looking for marijuana grower
Last Updated: Tuesday, April 15, 2008 | 9:52 AM CT
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The Canadian Press

Health Canada is looking for someone to grow its weed.

The department served notice Monday it will soon invite firms to bid on a contract to cultivate and distribute medical marijuana, which is now being done in Flin Flon, Man., by Prairie Plant Systems Inc.

The winning firm will be expected to deliver a steady stream of government-approved dope to certified medical users starting in the fall.

Health Canada posted a notice on a government tenders website saying it would put out a formal request for proposals in the spring of 2008, without specifying a date.

Ottawa has been a reluctant supplier of pot since a series of court rulings forced it into the medical marijuana business. The marijuana program licenses certified medical users to grow their own pot, to have someone grow it for them or to buy it straight from Health Canada.

The department has paid Prairie Plant Systems more than $10 million to cultivate government-certified dope in a mine shaft in Flin Flon, Man.

The company couriers the weed directly to users in 30-gram packets.

Health Canada first awarded Prairie Plant Systems the deal in late 2000 and has been extending it in six-month increments since 2006, says company president Brent Zettl.

He added the company has yet to decide whether it will bid on the new contract, although he expects it will.

"We didn't expect that this process would be able to continue. These are the rules that they have to abide by," Zettl said.

"We had anticipated internally that something would have to happen. We expected it would be something along these lines."

The winning firm could wind up in the advantageous position of one day being the sole supplier of medical marijuana.

Health Canada to end licensing of home-grown marijuana

Health Canada has said it plans to eventually end its licensing of home-grown weed. That would force all medical users to buy their supplies directly from Ottawa, perhaps through pharmacy distribution.

Ron Marzel, a Toronto lawyer who recently brought the matter before the Federal Court on behalf of a group of medical users, said he's concerned about any monopoly on legal production and supply of the drug.

"The government's just had such a horrible track record in terms of supplying medication to patients," he said. "There are many different strains of cannabis out there and the government's position to date has been, 'Well, we're growing one strain and we've got one supplier and that's it. Live with it.'

"The pharmacological evidence is that different ailments require, and different symptomology require, treatment with different strains. And the government hasn't paid heed to that at all."

The Federal Court decision in January struck down a key restriction in the government's pot program.

A judge's ruling eased Ottawa's grip on medical marijuana by allowing growers to supply the drug to more than one user. Prior to the ruling, each licenced grower could supply only one licenced user.

The federal government is appealing the decision.

A potential treatment for multiple sclerosis (MS), developed by University of Greenwich in association with Kings College, London, has begun clinical trials.

The life sciences company BTG plc, which has licensed the research, is running the trials on a new compound, known as BGC20-0134.

Dr Laurence Harbige and Dr Mike Leach, from the Biomedical & Drug Discovery Research Group in the University of Greenwich School of Science, developed the new treatment following many years of research.

Dr Laurence Harbige explains: "Although the cause of multiple sclerosis is unknown, there is strong evidence that it involves the regulation of the immune system through molecules in our bodies called cytokines. In MS, the balance of these cytokines is altered, leading to inflammation in the brain which can result in serious disability."

Dr Mike Leach adds: "This new treatment should encourage the immune system to rebalance itself, by inhibiting the production of inflammatory cytokines while promoting the production of helpful anti-inflammatory ones."

These initial trials, in volunteers, will look at how the new treatment works in the body and whether it leads to an increase in the helpful cytokines. A pilot study of a prototype treatment developed by the University of Greenwich team, which is related to this compound, has already shown promising results. It demonstrated clinical benefits in patients with a common form of multiple sclerosis, called relapsing-remitting. It led to decreases in relapse rates, disability and pain, along with improvements in quality of life. Preclinical research on the new compound, BGC20-0134, indicates that it may be three times as potent as this prototype.

Professor Tom Barnes, Pro Vice-Chancellor for Research & Enterprise at the University of Greenwich, congratulates the team behind the discovery: "It is very good news that this research is now in clinical trials. Our university aims to carry out work which is useful to society and this discovery is a classic example of that. It highlights the excellence of the research staff at Greenwich and also the business orientation of the university, through this partnership with BTG plc. Drs Harbige and Leach are to be congratulated on this important milestone."

Louise Makin, BTG's Chief Executive Officer, comments: "The effective treatment of multiple sclerosis remains a significant unmet need. We are pleased to have started clinical development of BGC20-0134, which has the potential to address different forms of the disease and has the advantage of being an oral product."