Doctor discusses hurdles in getting FDA approval of Parkinson's drug

By Julie Fann
star staff
jfann@starhq.com

  
BRISTOL, Va. -- A neurobiologist who believes he has discovered a potential cure for Parkinson's disease is ready to begin clinical trials on the drug but is finding out that getting approval from the Federal Drug Administration and money from large pharmaceutical companies does not come without a cost - mainly time.
   Dr. Keith Latham recently met with a Young Parkinson's disease support group in Johnson City to discuss the next step in getting the drug, Parkinol, on the market, as well as what happened during his negotiations with large pharmaceutical companies when he tried to get them to invest money for clinical trials in humans.
   "No other drug out there has cured the disease in rats. All other drugs just paste over signs and symptoms, but this drug has the potential to cure. But how can we get there from here? I've tried going to big mega-pharma, but they've turned out to have their own agenda because they don't want to do much that is innovative," said Latham, who operates a small laboratory, appropriately named Innovative Technologies, by himself near his home in Bristol, Virginia.
   Latham said drugs that can provide a potential cure are considered too financially risky.
   For the FDA, the risk is that, if they approve the drug and label it as restorative, or neurogenerative, then it will overtake the market place, so they want to be "absolutely certain" that it works. "They want to do ten years worth of testing on humans, and supplement the drug with something else and see how that works. But, for people with Parkinson's disease, ten years is too long," he said. "We just don't have that kind of time."
   And, he said, large pharmaceutical companies such as Pfizer, Orion, and Glaxo-SmithKline see drugs that cure as a threat to the enormously lucrative market of other drugs that only relieve symptoms. "This is why (large) pharmaceutical companies only do incremental things. In the case of Parkinson's, they'll put the old drug in a patch because it's very safe, and they continue to make money. But to come up with something like I've come up with - they get all nervous and start looking at the floor," Latham said.
   Rats respond to Parkinson's disease by constantly spinning in circles, and Parkinol stops the spinning completely for approximately four weeks, Latham said. In humans, Parkinson's disease attacks the portion of the brain called the substantia nigra. Certain parts of the body use oxygen more than others, and the brain is one of them.
   "Huge amounts of oxygen make free radicals, which are extremely toxic because they are cells that are leaky in that they don't keep energy bottled up. Free radicals get away from normal biochemistry and start to kill off brain cells," Latham said, which results in symptoms of Parkinson's disease.
   As brain cells die, the level of dopamine, an important neurotransmitter in the brain, also drops substantially. Parkinol performs a two-fold task in that it simultaneously quenches free radicals in the brain and releases dopamine. A typical dosage of Parkinol may be daily, or, Latham said, patients could possibly take the drug for a couple of months and then be done with it.
   Latham is scheduled to meet with the Federal Drug Administration on June 3 to discuss the next step in performing clinical trials. "It is a pre-IND meeting. IND stands for Investigation of a New Drug. At this meeting, I will tell them what I plan to do and how much it will cost."
   Latham will then send the FDA an INDA (Investigation of a New Drug Application) which will include extensive data from pre-clinical work and the protocol for performing phase one trials on humans. Latham will need 10-20 patient volunteers.
   Clinical trials have already been set up for two other Parkinson's drugs at a Mayo Clinic in Jacksonville, Fla., Latham said. "We're happy about that. They helped me on the marketing side with the FDA. The thing that happens is any time you do something new your face value goes up in partnering with companies or investors. The face value of the drug goes up because you've reached a new step."
   Latham estimates the whole project will cost $5 million, and he and his wife, who was diagnosed with Parkinson's disease seven years ago, have already invested $400,000 into it. The problem, Latham said, is figuring out how a small, for-profit company should ask for donations.
   "Pfizer would be laughed out of the county if they asked for donations for drug research, but I'm a small operation. We've provided information on our Web site and updated it with information about the drug. If one million people each gave five dollars, we would have all we need."
   Latham has performed neurological research on degenerative illness as a result of human aging for the past 20 years. He also holds degrees in electrical engineering and biophysics. Following post-doctoral training in pharmaceutical chemistry and molecular endocrinology, he spent 10 years as a professor of medicine and has published over 75 scientific papers, book chapters and abstracts.
   Approximately 1.5 million people in the United States suffer from Parkinson's disease, and 40 percent of them are under the age of 60.
   Information about Latham's work and how to make a donation to his project are available on the Web at www.parkinsons-research.com.