Once again, Word on Health brings you news of a potential breakthrough in the treatment of asthma. Researchers in Australia believe that a drug used to treat rheumatoid arthritis could also help patients with asthma. According to a paper published in the Lancet the scientists from Down Under have identified two mutant genes that may predispose a person to asthma. After comparing 58,000 DNA samples of people living in Australia, Europe and the United States they found two regions of the DNA that are consistently different between asthmatics and non-asthmatics.” One of the genes is also linked to rheumatoid arthritis (RA) and the researchers suggested that the drug tocilizumab, which is used to treat RA, may also work for asthma. Tocilizumab, marketed under the brand Actemra by Genentech, targets a certain molecule in the body called “interleukin-6 receptor” and reduces inflammation in RA patients. “Targeting interleukin-6 receptor may be a good strategy to reduce or prevent inflammation (in asthma) in the same way that it is used to prevent or reduce inflammation in rheumatoid arthritis,” suggests lead author Manuel Ferreira at the Queensland Institute of Medical Research. Word on Health awaits further research to confirm if and how the drug may help asthma patients. We’ll bring you further news as we hear it.
Few topics inspire more heated discussion among drug developers and pharmaceutical industry watchers than the regulation of new products. For those unfamiliar with the debate, the two sides of the argument can be summarized as follows.
Industry veterans feel that excessively conservative regulators squelch innovation in a desire to cover their own behinds, while industry critics contend that regulators aren’t strict enough, and that pharmaceutical companies should be held to an even higher standard and warrant even greater supervision.
In the meantime, patients wonder why modern science hasn’t produced the medicines they so desperately need.
Now it seems there may be an answer that could satisfy everyone. Susan Desmond-Hellmann, Chancellor of the University of California, San Francisco (UCSF) and former Genentech executive, suggests turning drug approvals from a discrete yes or no variable into a continuous moving target.
The fundamental problem with the current system, Desmond-Hellmann observes, is that regulators have only two options, when in fact, it might make a lot more sense for them to have a range of choices. She proposes that agencies, such as the FDA, could approve a drug for limited use, or use with limited promotion, following the submission of initial acceptable evidence of safety and efficacy. Permission for broader use, and less restrictive promotion, could be given after additional data are obtained.
This solution appears to make sense on many levels. It acknowledges:
- the long time it takes to become familiar with a drug and learn some of it’s more subtle effects – good, as well as bad
- the importance of accelerating the time it takes to get potentially useful drugs into the hands of patients who might need them
- the technologies now available to track and assess the performance of new drugs
One advantage of such a system would be the emphasis it would place on durable results, as full approval would likely require not just success in a clinical trial, but continued demonstration of success under “real world” conditions. Such a requirement would almost certainly stimulate the development of integrated “health solutions,” a bundled assortment of patient- and physician-support programs accompanying the drug.
Although a graduated regulatory approval process would not be perfect; it is almost certainly a significant step in the right direction.
Patient and physician educational and adherence programs make sense, but many companies have been reluctant to invest in them. In the context of an offering that would need to succeed in order for a drug to be fully approved, the incentives are considerably more apparent, and would almost certainly stimulate interest in companies striving to deliver the most effective patient support programs.
However, the big questions still remain. Are regulators ready for such change? Is the Industry ready to take on the responsibility and cost of ensuring appropriate use of their products and long-term pharmacovigilance? Would patients and consumer watchdog organizations accept a tiered approach?
What do you think? SRxA’s Word on Health would love to know.
U.S. researchers say they’ve found a way to eliminate the source of immune system molecules that cause asthma and other allergic diseases.
These soluble IgE moleclues are produced by immune cells called B cells. While targeting IgE in the blood is an effective treatment for moderate-to-severe allergic asthma, this approach doesn’t stop IgE production and patients require repeated treatments.
According to the May 10 edition of the Journal of Clinical Investigation, scientists from Genentech say they’ve developed a way to eliminate IgE-producing B cells. This finding could potentially lead to new long-lasting treatments for asthma and other allergic diseases. So far the method has only been tested in mice, where it proved highly effective.
Word on Health awaits the results of future studies in humans.