It costs on average $802 million to develop a new drug, but not every drug makes it to market. Many are stuck in clinical trials and could take more than a decade to get approved. Critics claim the FDA takes too long to give the go-ahead to life-saving medications and therapies. Others believe it's better to be safe than sorry. Lives hang in the balance of this debate.From a bright and beautiful teen to a woman with wisdom and compassion beyond her 21 years, Abigail Burroughs fought hard before losing her battle with neck cancer. In the last seven months of her life, she not only fought her disease, but the federal government as well."I wish that they would just sit down and get to know me and then be able to sit down and look me in the eye and tell me, 'No,'" she said in an interview before her death.
The Food and Drug Administration refused Abigail access to a drug that may have prolonged and even saved her life. After she died, the drug she was fighting for -- Erbitux -- was approved."There is just this mindset that if we have any kind of change it will hurt the clinical trial system," said Frank Burroughs, Abigail's father.Abigail's father created the Abigail Alliance to take her fight to Capitol Hill. The ACCESS act, before the house and senate right now, allows terminally ill patients who have exhausted all other options access to investigational drugs."There's a lot of lives that could be saved and extended ... tens of thousands of lives," Frank said.Even Steve Walker and his wife Jennifer, both scientists, well versed in policy, government regulations and research, were no match for the FDA. Stage four colon cancer ravaged her body."Jennifer was 45 years old at the time and far from done with making her mark in life," Walker, co-founder of the Abigail Alliance, told Ivanhoe. "We intended to beat it, but being scientists, we knew very quickly that the chances of doing that were not good."They talked with the FDA for months to get aggressive drugs already approved in 29 other countries."They don't work with you if you're a patient," Walker said. "In fact, they do the opposite. They aggressively serve and function as a barrier against your attempts to stay alive."Some experts believe using experimental drugs could end in disaster."I don't think patients are in need of experimental drugs," Colin Begg, Ph.D., a board member on the Society for Clinical Trials, said. "What they are in need of are drugs that actually work."The Society for Clinical Trials opposes the ACCESS legislation calling it "a bad law." it claims the history of medicine proves many drugs that initially seem promising are later revealed to be worthless or harmful."Statistics show that 90 percent of all drugs that pass phase 1 testing are ultimately shown to be ineffective or too toxic," Dr. Begg explained.It typically takes pharmaceutical companies six years after discovering a promising molecule to gather enough data to begin clinical trials. Completing a trial takes another seven years. The FDA says it's time well spent. Cheri Gunvalson says it's time her son doesn't have."I believe that there will be nothing more difficult on this earth than to watch my child deteriorate and to lose my child," Cheri Gunvalson said. Her son Jacob is living with a rare form of muscular dystrophy."I have hope to just get this drug … to just get it before it's too late," Jacob said.In August, a federal judge ordered the drug developer PTC therapeutics to give Jacob the experimental drug that could stop the progression of his disease. An appellate judge has since granted a stay, stopping Jacob from getting the drug right now"With younger boys, it may help them get stronger, but with a boy at Jacob's stage, it's just to preserve what he has, so the longer we wait, the less function he has left to preserve," Cheri explained."What's got me down? That I might not get this drug, and if I don't get this drug, we all know what that means," Jacob added.Experts fear granting early access to patients like Jacob means other patients won't sign up for controlled clinical trials."It's likely there will be a disincentive to patients to actually participate in the kinds of trials that will tell us in the long run what drugs work and which ones don't," Dr. Begg said."Nothing could be further from the truth," Frank said. "A patient would have to first try to get into a clinical trial and if they could not get into a clinical trial, then they could have access to a new drug that's in development.""The doctors would have all these choices, but they wouldn't have any evidence," Dr. Begg stated."These are not drugs, these are not therapies, these are research activities and people need to understand that." said Michael A. Grodin, M.D., professor and director of the Law, Medicine, Ethics and Human Rights Program at Boston University in Mass."Those patients are literally being driven to the grave by an FDA that doesn't know how to get out of the way," Walker remarked.The two drugs the Walkers fought are now approved by the FDA. All 16 drugs the Abigail Alliance requested earlier access to are now approved."Over a million people who could have benefitted from these drugs never had a chance to get them," Frank said.The Alliance is focusing on approval of nine more cancer drugs. Although it's too late for his daughter, Frank and the others will push forward for the lives they've lost and the lives they may save."I work every day for her, but I work every day for a lot of other people," Frank explains."Jennifer didn't want help just for her … she wanted help for everyone," Walker said about his wife."I need to know at the end of the day that I've done everything that I can to save his life," Cheri said.The ACCESS act also pushes for placebo-free drug trials in hopes more people will get involved in clinical trials if they know they will be receiving the drug in question.
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