Look out Nissen at it again
Later this afternoon Insulet (NASDAQ:PODD) will report results and while it won’t be stated, they should thank their lucky stars that the OmniPod is already on the market and not waiting for FDA approval. Not content to wreak havoc on the drug approval process, which has slowed to a crawl, Dr. Steven Nissen, that crusading cardiologist has now turned his attention how medical devices are approved. And surprise, surprise Dr. Nissen believes the FDA has not been tough enough when approving medical devices and this is lack approach is leading to untold deaths.
To see what Dr. Nissen has to say on the subject check out the most recent online issue of the Archives of Internal Medicine. According to a study entitled; “Medical Device Recalls and the FDA Approval Process”, Dr. Nissen and his colleagues conclude; “Most medical devices recalled for life-threatening or very serious hazards were originally cleared for market using the less stringent 510(k) process or were considered so low risk that they were exempt from review (78%). These findings suggest that reform of the regulatory process is needed to ensure the safety of medical devices”
Looking at the diabetes device market in particular the study states; “The second largest high-risk recall category (24 % of the total) was made up of 27 general hospital devices, including insulin pumps, intravenous infusion devices, and patient lifts. Seventy-four percent of these recalled devices were cleared through 510(k) review (n = 20) and only 22 % were approved through the more rigorous PMA process (n = 6).”
The authors conclude their study with the following passage;
“Medical devices cleared through the less rigorous 510(k) pathway comprise more than two-thirds of the products that are recalled by the FDA because they could seriously harm patients or result in death. When devices that were intentionally exempt from any FDA review were added to the 510(k) devices, they comprise more than 3 out of 4 of the high-risk recalls during the last 5 years. Thus, the standards used to determine whether a medical device is a high-risk or life-sustaining product prior to approval are clearly very different from the standards used to recall a medical device as life threatening. Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy.
The results of the present analysis indicate that the number of high-risk recalls of medical devices and the number of patients affected by these recalls would be substantially decreased if the following changes were made in the FDA process:
- The FDA fully implements current law that subjects “life-saving and life sustaining” (Class III) devices to the PMA process;
- The FDA’s definition of a high-risk device takes into account the potential risks if the device fails;
- The FDA expands the use of their authority to inspect the manufacturing of 510(k) devices just as they do for devices approved through the PMA process; and
- The FDA strengthens their authority to use special controls for 510(k) devices as they do for PMA devices, such as postmarket surveillance, performance standards, and product-specific and general guidance documents.”
Although Diabetic Investor does not know Dr. Nissen personally, his reputation is well known. Thanks to Dr. Nissen and his zealousness to protect patients we spent years dealing with the Avandia controversy. Thanks to Dr. Nissen and his fondness for meta-analysis it is next to impossible to get a new diabetes drug approved. Thanks to Dr. Nissen and his crusade the FDA has become scared of their own shadow and has forgotten that their mission is to use scientific evidence and not voodoo mathematics when making decisions.
Based on his crusade it appears that Dr. Nissen not only favors greater regulation and greater government interference, he wants to deny patients access not just to better drugs but better devices too. Never mind that the Avandia controversy that he created has done more harm than good or that patient’s stopped taking their meds because they were so afraid. Never mind that drug companies must now spend even more to do studies that will essentially prove nothing just because the FDA is run by fear and not science.
Diabetic Investor hasn’t quite figured out what Dr. Nissen is trying to accomplish other than remain in the spotlight. There two things the good doctor craves, seeing himself on television and disguising this goal as being a crusader. Maybe Diabetic Investor missed the press release but when this cardiologist appointed as an expert on diabetes, diabetes drugs, diabetes devices and the FDA.
Diabetic Investor shudders to think of what this recent crusade will do to the diabetes device market. A process that is just as painful and costly as the drug approval process.
The question is when will someone stand up to Dr. Nissen and his crusaders and tell them to get off their soap box and get back to what they know, at least we think Dr. Nissen knows cardiology although you would never know it with all his other interests. That someone would tell the good doctor that diabetes is growing at epidemic rates and by the year 2050 1 in 3 Americans will have diabetes. That two-thirds of patients are not properly controlling their diabetes and that we need more not less tools to fight diabetes.
Most of all someone should remind the good doctor, who we assume is a smart guy, that there is no such thing as a 100% safe drug or device. That there is something called risk/reward profile. That America will become a third world country as companies will get feed up dealing with a screwed up FDA and will take their drugs and devices to Europe and Asia.
Diabetic Investor is not against safe drugs and devices, what we’re against is a publicity seeking zealot who pretends to care about patients just so he can see himself on television. Even worse the FDA listens to what Dr. Nissen has to say which gives him an air of legitimacy. Frankly the FDA should thank the good doctor for his concern and tell him it’s time to get back to cardiology, if he can remember what that is.
