First embryonic stem cell trial stalled

The FDA has delayed approval of an application for the first human embryonic stem cell clinical trial by Geron Corporation, the company linkurl:announced;http://www.geron.com/media/pressview.aspx?id=840 yesterday. Geron's compound, GRNOPC1, is a cell-based therapy to treat spinal cord injury. Yesterday, the FDA told Geron verbally that they were placing the Investigational New Drug submission of the treatment under a clinical hold. The company is awaiting a formal letter. Thomas Okarma, Ge

By | May 15, 2008

The FDA has delayed approval of an application for the first human embryonic stem cell clinical trial by Geron Corporation, the company linkurl:announced;http://www.geron.com/media/pressview.aspx?id=840 yesterday. Geron's compound, GRNOPC1, is a cell-based therapy to treat spinal cord injury. Yesterday, the FDA told Geron verbally that they were placing the Investigational New Drug submission of the treatment under a clinical hold. The company is awaiting a formal letter. Thomas Okarma, Geron's president and chief executive officer, said in a press release: "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." Ren Benjamin, an analyst with Rodman & Renshaw, told linkurl:Bloomberg News;http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aEz5ggrE0.HU that the FDA's decision was not surprising. The agency held a linkurl:meeting last month;http://www.the-scientist.com/blog/display/54544/ to consider what guidelines to recommend for sponsors developing human embryonic stem cell-based therapies. Celia Witton, spokesperson for the FDA, said at that meeting that the agency had to process a tremendous amount of information before they can decide how to properly regulate trials for new therapies.

Comments

Avatar of: anonymous poster

anonymous poster

Posts: 26

May 15, 2008

It seems to me that very little regulation should be required. There is a sizable population of people wasting away and dying from spinal cord injuries. Why not give them a chance? Hopefully the company has made an effort to design something that will not turn cancerous at high frequency. And, if the frequency is very high or side effects are so severe as to further debilitate these "last hope" patients, it should become obvious early in the trial.\n\nBaxter Zappa
Avatar of: GERALD SCHNEIR

GERALD SCHNEIR

Posts: 2

May 15, 2008

You still have to go slow. The potential ramifications, scientific/medical not political, are so great and potentially very devastating and not immediately visible. People with severe injuries need the treatment benefits but what if the adverse results are worst than the injuries? Unfortunately, some of the delay at the FDA may be political in nature.\n\nG Schneir
Avatar of: anonymous poster

anonymous poster

Posts: 23

May 15, 2008

I feel those that regulate drugs or anything else for that matter should be made up of equal numbers of those with the mandalay the drug or procedure teats, doctors that treat the conidion, and members of the regulatory agencies. There should be no meetings or decisions unless maker of the drug or procedure and all parties are present.\n\nThe idea of drugs or treatment without risk is ridiculous in the extreme. We are left in a position that we must use old drugs that are less effective and are a greater risk to our health than newer drugs that are safer and do a better job with less side effects but have not been approved, had their approval revoked, have been withdrawn or worse yet never considered because they have or might have an ever diminishing risk of causing harm to some of the people that take it.\n\nAs I sit here in pain that has plagued me from July 5, 1981. I curse the lawyers, courts and regulators that are behind Merck?s choice to remove Vioxx from the market to limit their lability. Leaving me with the much more dangerous drug Prednisone as the only drug that comes close to doing the same as Vioxx did for me.\n\nWhile Vioxx had some risk of causing a heart attack or stroke. In my case the risk is not very high as I am not genetically predisposed to the conditions that Vioxx aggravates that trigger heart attack and stroke. I knew the risk I was taking and found living less years in less pain to be better than living longer in more pain or living even less should I choose to take Prednisone. \n\nI deeply resent the choice in this matter being taken away from me by over cautious bureaucrats that I believe have effectively put a stop to progress in bringing new drugs to market as well as taking newer drugs off the market with out looking at the old drugs that time has proved to be deadly. \n\nThe evaluation of risk seems to have become absolute that no new drugs that cause any risk to human life are allowed to be used even if they are safer than the currently available treatment. \n\nThey seem particularly reluctant to deal with drugs to control pain. The federal laws putting many pain killers under the hard cold eye of the DEA makes working with any drug those laws cover or any drug that acts like them much more difficult and expensive at every level.\n\nToday I seriously doubt that many drugs we consider safe such as Acetaminophen, Aspirin and even antihistamines could get approved. These drugs can all cause death and one is the foundation of the methamphetamine industry. In most states they are sold to anyone no matter their age that can get their money on the counter. \n\nThe FDA and US Government actually encourage the use of them by mixing Acetaminophen or Aspirin with opiates by making them easier to prescribe than opiates with out the toxic drugs. Acetaminophen & Codeine and Acetaminophen and hydrocodone can be prescribed by dentist or doctor on a regular prescription. The same drugs without the the Acetaminophen or Aspirin requires a prescription with an FDA number than has to picked up in person and is subject to great deal more attention by law enforcement. \n\nIn ?The Debate Over Acetaminophen and Acute Liver Failure?, Lee of the NIH Acute Liver Failure Group found Acetaminophen that is mixed with Codeine and other opiates cause 450 deaths due to liver failure. That is 30% of deaths due to liver failure and 50% of the cases of liver failure cases in the USA. The same report documents the deaths from Acetaminophen have increased by 49% from 2001 to 2003.\n\nWhat does the reader think the FDA would do with a new drug that could be directly traced to 5 cases of death by liver failure? \n\nWhen the UK took aggressive action to reduce the overdoses of Acetaminophen they were able to reduce the death rate 19% and a 56% reduction in liver transplants by reducing the package size, limiting the available quantity and making the pills more difficult to take by putting them in blister packs. Here in the US we ignore 450 deaths a year caused directly by Acetaminophen at best only mildly effective drug for pain relief that most people think is safe. A 5 year old kid can go to the store and buy all he can carry and has money to buy. That?s not a very safe way to sell something that 8 - 500 mg tablets can cause liver damage to a 60 pound child. \n\nYet we worry about unknown dangers to 20 or 30 people on the edge of death from spinal cord injury from treatment with embryonic stems cells a process that might prolong their life. At the worst it shortens a few months and these people take the risk willing in fact I expect there is long waiting list for the trials. I have a very minor injury to my spinal cord that?s nearly 50 years old. While I have been fortunate at the rate I am going down hill I will be in that line in a few years. make the trip to China to get it done or kill myself before I spend the rest of my life bed fast in pain that can?t be controlled. \n\ncd\n
Avatar of: Lee Roper

Lee Roper

Posts: 2

May 28, 2008

I resent anyone - be it the government, my neighbor, stockholders, or whoever - telling me what I can and can't take to treat myself for whatever illness or condition I think needs treating, whether that condition be physical, mental, psychological, spiritual, or simply a condition of wanting something pleasurable in a social situation. \n\nIt's interesting that some people can't seem to get this simple, yet most import, facet of personal freedom, a freedom to do to ones own body whaterver the hell one wants to do. They just don't get it, unless, of course, one is talking about alcohol. Other drugs, even those far less harmful, are considered to be in completely different categories than alcohol. \n\nTo me, in this context their seems to be two main differences between alcohol and drugs in general. The first is that when the government bans or severely restricts the use of drugs, the people who are affected are almost always splintered into subgroups that are defined by the particular drug being banned. Some of these people, like the gentleman above, are in pain. Some are dying from the overall effect of a disease. And, some have lost the use of a part of their body because of injury or genetic abnormality. They don't speak with one voice because they are simply fighting different battles defined by the particular drug they each need.\n\nThe second difference is that alcohol, unlike any other drug, is consumed by a great number of people for simple pleasure. The number is so great that there doesn't need to be a medicinal reason to generate public pressure for its use. The Prohibition proved this point beyond reasonable doubt. \n\nSo, why do find it so easy to apply a double standard regarding others, especially when they have much better, indeed compelling, reasons to be allowed to have their drugs. Are we so blinded by our own addiction to alcohol that we can't see this obvious hypocrisy, an hypocrisy that leaves countless people with much less hope, and in much greater pain?

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