By: Jean Johnson for Wounds1It’s been three quarters of a century since an injected insulin treatment was first discovered in the 1920s. Since then, diabetics have relied on insulin injections to help manage the complications associated with their complex metabolic disease.
| Learn More |
Fast Facts about Exubera:
The drug is expected to go on the American market in summer 2006
The new inhaled form of insulin acts for a shorter period of time than injected insulin, and it is designed for use before meals.
Exubera will not replace longer-acting injectable insulin in patients whose diabetes requires this type of therapy.
Exubera is expected to cost three times the amount of injectable insulin.
|
As Paul Matelis sits in the stands watching the Orange Bowl, his body’s need for insulin signals that it’s time for intervention. But it’s the 21st century now and there’s no problem, according to the 54 year old from Miami – he has used a newly approved insulin inhaler in clinical trials for seven years. The new device fits into a sunglasses-sized case but at a foot long when in use, the inhaler is anything but discrete. Not an issue said Matelis; “It’s much easier to take a puff than to load up a syringe and inject yourself…”
In January 2006, both the Federal Drug Administration and the European Commission approved the insulin inhaler for marketing by mid-year. Under the name of Exubera, the inhaled form of insulin should be available in the United States by this summer.
Exubera History
This dry powder form of short-acting insulin is used prior to eating and will not take the place of longer-acting injected insulin. Still, researchers have tried for decades to come up with some non-invasive insulin treatment like patches, or specially coated pills that stomach acid won’t penetrate. However nothing until Exubera came along has functioned adequately enough to bring to the market.
It took Nektar Therapeutics years to develop the powdered insulin used in the inhaler. The powdered insulin needed to be in particles easily absorbed by the lungs. Also, to make Exubera portable, they needed to find a form that does not require refrigeration as does injected insulin. While the big diabetes drug companies were not interested, Pfizer took note and has since collaborated with Sanofi-Aventis on the project.
The Numbers
There are currently 5 million people using insulin in America, and a total of 20 million diabetics. In the United Kingdom, 1.8 million people live with the disease. With a disease of this prevalence, Exubera is expected to generate $2 billion in sales globally by 2010, with a billion of that made in the United States alone. The drug will cost between $120 and $150 a month, around three times the price of injectable insulin. At this point all looks well for the companies involved, although should problems with the drug arise, hopeful business prospects could vanish as quickly as they appeared.
The Benefits
“Being able to replace some of the daily injections with an inhaler will be a great breakthrough for some people with diabetes,” Said Simon O’Neil, M.D., the director of care at Diabetes UK.
Although Exubera was not approved for use among children, the chief scientist of the Juvenile Diabetes Research Foundation International, Robert Goldstein, M.D. agreed with Simon’s assessment. “The thing that people with diabetes who have to take insulin hate the most are shots,” said Goldstein. “So anything that can replace shots, patients are going to be very pleased about.”
A Belgium researcher from the University of Leuven, Chantal Mathieu, Ph.D., noted that a greater compliance from patients with Type 2 diabetes might be forthcoming. This type of diabetes is largely adult onset and arises from a combination of obesity and inactivity, and those diagnosed with Type 2 diabetes are often unwilling to inject insulin.
“With Exubera,” said Mathieu, “patients now have another opportunity to take control of their blood sugar and take an active role in managing this complicated disease.”
Others say that these days, the injections aren’t that bad. According to some, tiny needles and pen-like injectors have made the prospect of taking insulin less painful than pricking fingers to check blood glucose levels. For example, Jay Skyler, M.D., associate director of the diabetes research center at the University of Miami, thinks Exubera will probably largely appeal to “people who have never been on injections… because they think the injections are going to be difficult for them.”
The Caveats
Experts and pundits note that since Exubera is relatively short-acting, many diabetics will still need to supplement their insulin with morning and evening injections. Also, and more debatable, are concerns about the inhaled insulin’s long-term effects on lung tissue – a key reason the FDA did not approve the drug for children’s use.
Marc Sandberg, M.D., medical director of the Diabetes Health Center in Flemington, New Jersey, noted that “We don’t have long term studies on this medication.”
Also, since various scares over drugs with potentially adverse side effects have occurred since 2004, such as the uproar over Vioxx, the FDA’s credibility itself has come under question. The Center for Science in the Public Interest (CSPI) says that before the FDA, a federal agency charged with overseeing the public’s safety, makes drugs that will be extremely attractive to the American people it needs to make sure it has no conflicts of interest rumbling around in the back of the closet.
The CSPI raised a red flag when it found three members of the FDA’s nine member advisory panel that recommended Exubera for market had direct ties to Pfizer, including the panel’s acting chairman who owns stock in the company.
“The public’s faith in the integrity of the process is undermined when a third of an advisory council’s membership has significant financial ties to the company seeking the product’s approval,” said director of the Integrity in Science project at the CSPI, Merrill Goozner.
The FDA countered that it cannot find suitable expertise without ties to industry. In response, the CSPI points to the many knowledgeable research Ph.D.s and M.D.s in the nation’s universities and medical schools. “It is ludicrous that the FDA could not find highly qualified experts in these fields who did not have ties to the manufacturer,” said Goozner.
While Pfizer was ready to ask the FDA for approval in 2004, the agency asked the company to hold off while further trial results relating to the medication’s affect on lung tissue were accumulated.
“I think that we and the advisory committees felt that there was very robust data with regard to the safety of the drug in patients without underlying lung disease,” said Dr. Robert Meyer, director of the FDA office overseeing diabetes drugs.
