US expert: Halt stagnation in drug development

The development by pharmaceutical conglomerates of new medications has stagnated during the past decade due to the expense of development and clinical trials that is rising exponentially, according to Prof. Giora Feuerstein, chief medial and technical officer of the US Department of Defense.

The US physician and pharmacologist, who is a veteran expert in translational science and drug development in US pharmaceutical companies and was trained at the Hebrew University of Jerusalem, was speaking at the Presidential Conference symposium on “The Future of Medicine.”

(Translational science is cross-disciplinary research that seeks practical applications that help people.) Feuerstein told the audience of some 200 that the making of medicine is “everybody’s business.”

But the fact that the costs of new drugs are unsustainable means that pharmaceutical companies buy each other out, drug developers become unemployed and there are fewer new and more effective medicines. It needs a new business model, he declared, and this must be a consortium bringing together governments – especially those with national health insurance systems as in Israel – and academia.

“They must come down from their ivory towers and help,” Feuerstein said. “Private industry cannot do it alone, and there must be globalization of medical information on diseases.”

He said that medicine, as we know it, will change completely and that the signs are already here. Terms like proteomics, genomics and metabolomics will be common terms used to predict what diseases people will develop years before their symptoms actually appear. “To deal with the ageing problem, we will have to begin at an embryonic level or at birth, saving the placenta and umbilical cord and freezing them,” said Feuerstein.

Years or decades later they could be used for organ engineering to provide replacements for sick ones, before the medical problem begins, he added.

“We need an integrated system biology, a package of information that is always on board. The capabilities [of healing] will always be there. We are moving to a totally different era. In the last 50 years, the foundations for synthetic biology have been laid... On this basis, we could built new organs... You will be able to treat yourself by ‘your self.’ One could even say: “I want better muscles to win a marathon; it won’t have to be disease oriented.”

David Agus, professor of medicine and engineering of the University of Southern California, as well as co-founder of Navigenics, a personal genetic testing company, recalled giving an interview to Nightline on ABC TV. He sequenced the DNA of the host, a seemingly healthy 42-year-old man, and found that he was at high risk for heart disease. After conducting a catheterization scan, which Agus said costs only $79, the star was found to have a 80-percent blockage of a coronary artery, which was “fixed” in a hospital.

“The next day, the American Heart Association called to protest why I screened him for heart disease. I was told that the man was not eligible for screening, as he was too young. If everybody got screened, there would be chaos,” he was reprimanded.

Dr. Uma Raman Kotagal, a neonatologist and health services researcher by training and senior vice president for quality and transformation at Cincinnati Children’s Hospital Medical Center, was less than optimistic. “Healthcare is often unsafe and ineffective, wasteful and inefficient.”

She advised people who had to be hospitalized to take someone with them to check the medications they were given and generally keep an eye out.

She also noted that half of patients have to wait 17 years on average before a new medical technology benefits them.

But the Internet and social networks, she said, are already beginning to spread medical knowledge and experience among patients, who would report their progress and feeling that would add to medical knowledge. “We are creating communities of care, teams of pediatricians and computer scientists, for example, that turn doctors and patients into collaborators for new knowledge.”

Hebrew University Prof. Hermona Soreq, a pioneer in molecular biomedicine, concluded that disease needs “system engineering, not only one doctor and one patient. We need earlier diagnosis methods.

Human beings are different, which means that in clinical studies, we need a lot of individuals, which is hard in a small country [like Israel].”

But she described promising Parkinson’s disease research she has done with her HU and Hadassah University Medical Center colleagues using little glass chips with data to get a profile of patients’ gene expression and differentiate between healthy or sick individuals.

These signature genes reflect the effect or neurological surgery in which electrical pacemakers can control severe palsy.

“Now we have to find out which gene is a button on which we can press to stop effects of the disease, just the way deep-brain stimulation did,” she said.