Welcome to the job Dr. Hamburg

Welcome to the job Dr. Hamburg

This morning the Pharmaceutical Research and Manufacturers of America (PhRMA) unveiled a new report today on medicines in the research pipeline for diabetes. The report shows that America’s pharmaceutical research and biotechnology companies are testing a record 183 new diabetes medicines. The medicines listed in the report are being tested in human clinical trials or are awaiting approval by the U.S. Food and Drug Administration.

On Monday the Senate confirmed Dr. Margaret Hamburg as the next Commissioner of the FDA. While these two events may not seem related it does point the tough job assignment that awaits Dr. Hamburg.

Dr. Hamburg comes in facing several key issues that are directly related to the diabetes market. She also takes over an agency that has strayed from its stated mission of using evidence based medicine to make decisions, to an agency that has lost all sense of balance and appears to be actively looking for reasons NOT to approve new drugs. We can only hope that Dr. Hamburg can ride the agency of its fear of making a mistake and restore some confidence in the over-worked, overwhelmed FDA staff. Lastly we truly hope that Dr. Hamburg can find some perspective on which experts the FDA can work with. Disclosure rules have become so cumbersome that many highly qualified leaders in their respective fields will no longer participate as the cost is just too high.

Diabetic Investor does not envy the job facing Dr. Hamburg who just may walk into her new office and wonder why she even wanted this job in the first place. We all know that our government is one giant bureaucracy but the FDA is a stranger in a strange land. To illustrate just who strange things are at the FDA let’s examine how the agency handled the GDH-PQQ enzyme issue which has the potential to cripple two of the leading blood glucose monitoring companies, Abbott (NYSE:ABT) and Roche.

This is an issue the FDA has been aware of since 2005 and could have been easily handled without reaching the catastrophic level it has become today. Looking over the data there are approximately 360,000 patients that undergo kidney dialysis of those patients about half (45%) have diabetes which gives us a patient population of approximately 162,000.  According to latest government figures there are 24 million patients with diabetes, 18 million that are actually aware they have diabetes. Doing some quick back of the napkin math that means this PQQ issue effects less than one-tenth of 1% of the diabetes patient population; 0.009% to be exact.

The FDA also knows which monitors and test strips use the PQQ enzyme. One just might think the agency would contact every hospital, kidney dialysis center and specialists in kidney disease informing them of the issue and which monitors they should and should not use with diabetic patients who are undergoing this procedure. The FDA could also go a step further and require that any manufacturer who chooses to use this enzyme place a label on the test strip vials warning patients, information that would also be contained in any package inserts.

We do after all have something called the internet which the FDA could use to post an up to date list of monitors which use the PQQ enzyme. This would also be a cost effective method of tracking monitors that switch from PQQ to another enzyme.

Rather than follow this simple method, the agency appears set to take more drastic action. Already the agency has delayed the new Roche Accu-Chek Nano monitor over this issue, a monitor that is already on the market in Germany and the United Kingdom. According to several industry sources it’s possible, even likely that Roche won’t be allowed to launch Nano here in the US until they resolve this issue which could take another 4 to 6 months.

Diabetic Investor realizes that market conditions are tough for all the glucose monitoring companies however we suspect that Roche and Abbott would gladly sacrifice the 0.009% of the market where this issue applies. That would be a far better solution than the FDA recalling any meter and strip that uses the PQQ enzyme, a remote, yet still possible solution to this issue.

The fact the PQQ issue has become an issue at all speaks to the lack of perspective at the agency and how the agency can be influenced by major players in the industry. It’s no accident that LifeScan, a unit of Johnson and Johnson (NYSE:JNJ), has been conducting a quiet yet effective campaign around this issue. Diabetic Investor understands what LifeScan is doing as market conditions are tough and any advantage, even a miniscule one such as this, can give you an edge over competition. Still one would think that the agency would see through all this and actually look at that the depth, or lack thereof, of the problem. It doesn’t take an advanced degree in mathematics to figure out the number of possible patients where this issue will come into play.

Still this is the same agency that found it necessary to issue a warning about Byetta usage and pancreatitis without examining all the facts.  Had they bothered to investigate at all they would have found that patients with diabetes are at greater risk of developing pancreatitis and the incidence rate of pancreatitis and Byetta was actually LOWER than the diabetes population in general.

This is also the same agency that puts together a panel on Liraglutide, a drug for patients with type 2 diabetes, and selects a patient with TYPE 1 diabetes as the patient representative.

Dr. Hamburg’s first priority should be to get the agency to follow its stated mission of using evidenced based medicine when making decisions. Next, she should inform all FDA personal that there is something called a risk/reward analysis. Diabetes is not just a serious healthcare issue it is also a serious economic issue. No one, not even the FDA, can dispute the fact that the majority of patients with diabetes are not adequately controlling their diabetes and they need more, not less, weapons to help them control their diabetes.

It would also help a great deal if the agency instead of issuing decisions without providing any context or perspective more clearly stated the depth of a possible problem. The agency appears to be oblivious to the world we all live in where news travels instantly. The fact is the mainstream media and bloggers do not have extensive diabetes knowledge and rarely investigate an issue before reporting.  This is exactly what happened with Byetta when the mainstream media went for the jugular. Back when this story first broke Diabetic Investor contacted the agency who acknowledged that the agency did not consider this a serious issue. Still the damage was done as most people read headlines that basically said Byetta caused the pancreatitis. There is absolutely no evidence of this but the facts rarely get in the way of what the mainstream media considers a good story. The FDA should understand how things work and provide some perspective to their decisions.

But Dr. Hamburg cannot do this by herself and to be fair needs some help from members of Congress who could care less about the patient and just want their 15 minutes in front of television cameras. The agency will never be effective if every time a mistake is made they are called before Congress. Even when the agency doesn’t make a mistake this happens. One only needs to look at the Avandia circus to see how Congress rips the agency a new one on a drug that went through the approval process and was widely used for nearly seven years. The Avandia controversy illustrates clearly that members of Congress could care less about patients.

Although Diabetic Investor disagrees with the new guidelines the agency issued for approving diabetes drugs we can certainly understand the reasoning that went into these guidelines. Sadly Diabetic Investor doesn’t believe these new guidelines will do anything more than slow the drug approval process and create more not less questions. The fact is there is no such thing as an adverse event free drug.

Dr. Hamburg’s job is tough enough and quite frankly she doesn’t need Congress breathing down her neck. The fact of the matter is that everyone, patients, physicians and researchers have lost confidence in the FDA. Dr. Hamburg has drawn one of the toughest assignments in Washington. For the sake of all involved let’s hope she’s up to the job.

Diabetic Investor’s only advice to Dr. Hamburg is to remember something Paul Anderson wrote way back in 1969, “I have yet to see any problem, however complicated, which when you looked at in the right way, did not become still more complicated.”