Nissen at it again, this time it’s devices
It’s been some time since we last heard from that crusading cardiologist Dr. Steven Nissen and it looks like the good doctor is once again trying to get back into the spotlight. Not content to screw up the drug approval process for new diabetes drugs, the good doctor and his minions are now setting their sights on how the FDA approves medical devices. According to an article published in the most recent edition of Archives of Internal Medicine entitled; Medical Device Recalls and the FDA Approval Process, Dr. Nissen and his co-authors state; “Most medical devices recalled for life-threatening or very serious hazards were originally cleared for market using the less stringent 501(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.”
And just how did the good doctor reach this conclusion, again according to the article; “From January 2005 through December 2009, the FDA included 115 names of recalled devices (involving millions of units) on their high-risk recall list. Of these 115 recalls, the FDA designated 113 as Class I recalls, which the FDA defines as the highest risk based on information provided to the FDA by health professionals, researchers, patients, or device companies.” The article goes on; “The PMA process was used to approve only 21 of the 113 devices listed as high-risk recalls that cause serious health problems or death (19%). Eighty were cleared through the 510(k) proves (71%), and additional 8 were completely exempt from FDA regulation and were merely registered with the FDA (7%). “
Here is what the cardio crusader and his friends recommend;
“1. The FDA fully implements current law that subjects “life-saving and life sustaining” (Class III) devices to the PMA process;
2. The FDA’s definition of a high-risk device take into account the potential risks if the device fails:
3. 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
4. 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.”
In this same issue Jason Connor, PhD, Roger Lewis, MD, PhD, Donald Berry, PhD and Scott Berry, PhD issued a response to what the good doctor wrote and stated the following; “From 2005 to 2009, there were 16,522 medical devices approved via the 510(k) pathway and 145 approved via the PMA pathway. … Thus, devices approved via the 510(k) pathway had an approximate recall rate of 0.48% (80 of 16,522, while those approved via the PMA mechanism had a recall rate of 14.5% (21 of 145).
Never one to miss an opportunity to tell his critics how wrong they are, Dr. Nissen and his crusaders issued a response to the response and stated the following; “This analysis does not take into account the impact of dangerous medical devices on the health of patients or the costs of health care. It also does not consider the importance of federal agencies following the law consistently in their regulation of medical products.”
So far there has no response to the response to the response. (Sure hope we got that right.)
Diabetic Investor would like to say this is the last we’ll hear about this issue but knowing how the crusading cardiologist loves the limelight we know this is just the beginning; never content to let an opportunity for attention get away from him, look for the good doctor to use his political connections to get Congress involved. Yep, just what we need, more useless Congressional hearings that do nothing more than get our elected officials and publicity hounds like Dr. Nissen on television. More hearings we’re one side will bring out their statisticians to justify how they calculated their numbers and then we get to watch the other side bring out their stat guys who will argue the exact opposite.
Once again we’d get to watch FDA squirm, answering questions from the folks in Congress. More hand wringing, more calls for reform, more calls for more money from the FDA and when it’s all said and done, nothing of substance will result. Patients will not have safer medical devices, these devices won’t perform any better and they certainly won’t cost any less.
One thing you can take to the bank, other than seeing Dr. Nissen kissing any TV camera he can find, is the FDA, who is already approving new devices at a snail’s pace (and frankly that’s an insult to snail’s everywhere) will slow the device approval process, something Diabetic Investor just didn’t think was possible as the process is already moving slower than a glacier. Keep in mind the FDA is the agency that seems to think patients with diabetes are the same as heroin addicts who share needles passing deadly diseases to each other. This is also the agency that can’t give straight answer to simple questions asked by device companies who are trying to get new or improved versions of older devices approved. America is already in danger of becoming a third world country as nearly every device company is getting faster attention overseas than they are here in the USA.
Quite frankly if an FDA official walked up to Diabetic Investor on a bright sunny day and told us the sun was shining we’d make sure we weren’t dreaming.
Think for a moment if Dr. Nissen does for medical devices what he has done for the drug approval process. (We realize this is not a pleasant thought but do your best not to throw up.) Say goodbye to the artificial pancreas, insulin pens that communicate with a glucose monitor or any chance of using a smart phone to help manage diabetes. Frankly you can say good bye to almost any advancement in diabetes devices and once again patients will be the ones who suffer.
Diabetic Investor honestly believes the crusading cardiologist would prefer the FDA study every drug and devices six ways from Sunday no matter how long it takes and no matter how much it costs. The honest truth is if the good doctor gets his way it will only lead to even more government regulations and higher, not lower, health care costs. What the good doctor and his friends seem to forget is that for medical devices in particular device failures are commonplace and there is no such thing as a medical device that works 100% of the time. These are the same people who seem to believe that any adverse event from a drug, no matter how miniscule, means that drug should not be approved even if that drug could save millions of lives. Dr. Nissen and his minions come from the world where there is no such thing as risk/reward analysis, all they see is risk. This group also seems to believe that every drug and device company is run by Satan himself and all these companies care about is making money. Never mind that these companies are risking millions, if not billions, on developing new drugs and devices and the last thing we need in this country is the government telling companies what they can and cannot develop. Just in case anyone has forgotten America is still a democracy and the last time Diabetic Investor looked Americans believe in capitalism.
Diabetic Investor is not against sensible oversight that is based on solid scientific evidence. Nor do we believe the device approval process is good as it stands today, yes reform is needed. However, any reform or changes to the drug or device approval process must balance the needs of patients and the needs of the companies who develop these drugs and devices. Only Dr. Nissen and his friends seem to believe that these companies don’t care if their drugs or devices fail. They seem to ignore the millions these companies have paid because of their mistakes, this comes from another American tradition more commonly called the lawsuit.
On balance 99% of drug and devices companies want to have great drugs and devices because if they are successful they and their stakeholders will make money and as we noted before making money is not yet a considered a crime in America. How anyone can think that industry is just plain evil has some very serious issues. If Dr. Nissen thinks increased government oversight leads to better health care or lower health care costs he is more delusional than we thought.
The reality here is that Dr. Nissen wants one thing and one thing only; attention. Too bad there are people who not only give him what he craves but continue to encourage him. Even worse the FDA is paying attention and that is the most freighting aspect of all.