"Our institutional data for hysterectomy showed that robotic-assisted surgery translated into a $6000-$10,000 increase in expenses to the patient over all other methods of hysterectomy. If the 600,000 hysterectomies performed in the United States each year were all converted to robotic-assisted hysterectomies, this would represent a $3.6 billion to $6 billion increase in patient costs. An increase in patient costs for no clinical benefit."
What does the literature show? High-volume subspecialty surgeons have better patient outcomes and use less hospital resources and health-care dollars than low-volume, less-skilled surgeons (9). In fact, a hospital’s investment into a moderately priced robotic system over 5 years would provide an average salary for a fellowship-trained minimally invasive surgical subspecialist (conventional laparoscopist) for 10 years. Instead of investing in a marketing technique, hospitals should invest in and develop talented high-volume surgeons because the clinical benefit is proven.
In a time where medical bills are the leading cause of personal bankruptcy in the United States and health care spending is nearly 18% of the GDP, why are patients paying more for a technique without any proven benefits over conventional therapies? Why are hospitals marketing robotic-assisted surgery to patients without reviewing the manufacturer’s claims? Why are we allowing a single company’s bottom line to increase while insurance premiums and out-of-pocket spending for patients increase every year? We have to stop pursuing things because they are marketed to us. In medicine, there are always procedures that are feasible, but they are not always the right clinical choice; similarly, they are not always the cost-effective choice. In the case of robotic-assisted surgery, it shows neither improved clinical outcomes nor lowered costs.
"Unfortunately, the exuberant and rapid adoption of robotic-assisted surgery has occurred in the absence of randomized trial evidence validating its use. Instead, marketing by the manufacturer accounts for the exponential use of robotic surgery over the past five years rather than clinical evidence.
In fact, researchers from Johns Hopkins found that hospital websites, using manufacturer-provided content, misled patients with clinical claims that have not been substantiated (1). The researchers found approximately 4 in 10 hospital websites in the United States publicize the use of robotic surgery. What was most concerning was that 89% of these hospital websites made a statement of clinical superiority over conventional surgeries, the most common being less pain, shorter recovery, less scaring, and less blood loss. 32% made a statement of improved cancer outcome, and none mentioned any risks or costs.
The evidence is just beginning to emerge to the contrary. Literature has shown that while clinical outcomes are similar to or no better than conventional surgery, the robotic technique is more expensive than conventional laparoscopy for a number of surgeries including cholecystectomy (2) and hysterectomy for endometrial cancer (3). For some procedures, including benign hysterectomy, sacrocolpopexy (4), and myomectomy (5), the robotic technique is even more expensive than conventional laparoscopy and laparotomy. Despite the large number of robotic prostatectomies performed to date, evidence has yet to show improved clinical, cancer, or cost outcomes for robotic prostatectomy (6). In addition, studies show that robotic-assisted surgery is consistently $1600-$3000 more than conventional laparoscopy or open surgery (7,8). Our institutional data for hysterectomy showed that robotic-assisted surgery translated into a $6000-$10,000 increase in expenses to the patient over all other methods of hysterectomy. If the 600,000 hysterectomies performed in the United States each year"
Sentiment: Strong Sell
Yes I am a medical doctor and I can tell you if not for huge marketing value of the robots right now (because it makes any hospital or institution sound advanced and "space-age") and if not for large sums of financial incentives provided by feds, robots would have already been a thing of the past except for a very few docs who like toys.
Look at it this way: with more and more advances in scope procedures (we now even have aortic valve replacement at places like Cedar Sini using tinny valves deployed through blood vessels and without cracking ones sternum) many procedures (even gastric bypasses) are done using scope and as outpatient (such as cholecystectomy).
You ask why then Intuitive Surgical continues to have such revenues? Because like many government programs to help lift new ideas currently there are lop sided reimbursement provided by Medicare (and hence many others that are forced to copy Medicare) for robotic procedures that despite the hassle and all the other problems (I know some distresses cases even with simple procedures such as prostate cancer by reputable institutions like City of Hope that don't get publicized ) there is a tendency to use robot (even though in many cases they begin with robots but finish the old fashion way).
The day that Medicare money flow stops will be the beginning of the end for companies such as Intuitive. And even before that the flow of problems with these "toys" will continue and will make them less and less attractive. Even now around the US medical world the robotics are much less "sexy" than they were a couple of years ago and even those "toy lovers" and profit seekers exhibit alot of anxiety in using them but they feel they have no choice right now because they were advertised and because of the lop sided re-imburment as mentioned above.
As for the stock, I don't know what ISRG will do short term (I think it will have a delayed response to the latest news about problems and get haircut) but long term watch out!!
It has been awhile since my last post but I saw it fit to write the following today:
1-as mentioned before, the issue with Omontys is ONLY allergic reaction experienced by a VERY SMALL number of users. Otherwise there is nothing inherently wrong with the drug itself as it works just FINE and nearly 25000 relatively ill CKD folks on dialysis have used it to their benefit and without any unwanted consequences. Allergic reactions are just that, allergic reactions; they can be overcome in a number of ways and there is almost no drugs currently in the market that does not cause allergic reaction in certain people.
2-Takeda is highly regarded with many drugs in the market / pipelines and very savvy group of scientists and researchers/doctors; The fact that they were willing to go out of their way and agree to such a lop-sided agreement with Affymax, "assuming full responsibility for Omontys" while agreeing to pay millions of "milestone payments" as well as a lifetime of royalties tied to net sales both in US and the rest of the world, is an absolute vindication of #1 above: Omontys is a great drug with some issues common to many drugs that will be back in the market in a big way under the leadership of Takeda with definitely even better prospects that before the recall.
3-For those that knock this drug for profits reasons please don't; Omontys is a wonderful drug that is able to help thousands of CKD patients live a more normal life free of persistent and daily fatigue and weakness by getting once a month injection.
4-Fans of Omontys, specially the doctors and dialysis centers, will be excited to see that not only the current investigation of the Omontys but also the future production, distribution, and marketing of the drug is now being assumed by a much more powerful company such as Takeda; this will also help Affymax's bottomline more than before the recall. Also the hope will now be that the investigation will be wrapped up sooner under Takeda's leadership.
7-One main question to investigate is why 3 people died when a simple and timely Epinephrine injection could have saved their lives (Of course we have Epinephrine stand by in all floor in my hospital but even in my solo practice I have had stand by Epinephrine since my day one in practice).
8-It is abundantly and 100% clear to me that because of above Omontys will be back in the market and this may not be even with the need for a new warning or stand by Epinephrine. But even a new warning or stand by Epinephrine is placed on Omontys those are not big issues anyways.
9-I know this was a long note but I've tried to stay away from medical jargons so common folks won't have any problems for a fast reading. I don't believe the issue surrounding Omontys is as complicated as some make it.
CONCLUSION: There were 3 deaths which no way in the world Omontys as originally manufactured could have possibly caused and even those 3 could have been prevented with proper Epinephrine usage. Omontys will be back in the market sooner than most think and that the the company and others investigating definitely already have a pretty good idea what caused the reactions whether they say it this week or hold of for more documentation and proof. Furthermore, the recall was voluntary and Affymax does not legally, medically, or scientifically need but probably will seek and easily obtain FDA's nod and return to market.
Good night from California
3-The number of deaths, 3 in 25000 usage or 0.02%, is not large at all and some medication in use heavily right now, such as interferon or Fentanyl patches cause by far more deaths. Some other medications cause huge number of injuries and deaths over time, such as Ibuprofen, but none seem to be recalled.
4-item 3 above is why FDA did not order the recall and this was a completely voluntary move by Affymax. But why would Affymax do this? I think there were 2 reasons. First and foremost it seems Affymax wanted to hold the higher ground and show they are a responsible company where patients welfare is of paramount importance. Second reason I believe must have been that the shear number of allergic reactions and 3 deaths all of the sudden and out of the blue all in February was so surprising that once company did not find a certain defective batch at fault that it felt obligated to stop the use in order to avoid any further injuries until the cause is known.
5-The fact that no certain batch was found to be the culprit may actually indicate that Omontys manufacturing was most likely not the problem but possibly other agent(s) given to these patients at the same time as O most likely was/were at fault.
6-It does not take months or years to figure out what went wrong as most likely they already have a good idea but it takes a bit longer to document the data to show proof (all they have to do find the common thread amongst those effected). Furthermore, for whatever drug is found to cause the anaphylactic reaction a simple skin allergy testing can be developed. But that may not even be needed as a single Epinepherine injection will reverse the worst anaphylactic reactions. This would be similar to Epi-pen provided to thousands and thousands of people for home use who are known to have anaphylactic reactions to certain insect bits. As such all dialysis centers need to do is to have Epinephrine stand by which all already do.
This may very well be my last post here if the stage is set for Omontys issue is partially or wholly settled by this Thursday's CC. Of course some of you have read parts I & II of this series. I do, however, want to point out the followings (some of which is repeats):
1- As previously mentioned I have been practicing medicine for a few decades and getting ready to hopefully retire in the near future. There is an old saying that there are no coincidences in medicine. Any doctor, nurse, pharmacist, etc involved in today's health care can tell you with 100% certainty that there is NO WAY IN THE WORLD that you could have over 25000 patients take any drug, by injection or otherwise, without any serious side effect and then suddenly in February, and after 11 months of usage, you have 3 deaths unless there were some new external factors introduced. Science of medicine while complicated it also involves some simple common sense facts and this is one of those facts. Omontys as manufactured prior to February could not have possibly caused those deaths. The culprit could be something went wrong on February batches or other medications were begun to be given at the same time as O beginning February that could have caused this or the culprit could be dialysis equipment malfunction or defect, or..., or...., or....BUT NOT OMONTYS AS MANUFACTURED UP UNTIL FEBRUARY AND AS USED BY THE FIRST 25000 PATIENTS.
2-Omontys was and is well regarded by many physicians as once a month dosing allowed it to be administered in the nephrologist offices as well as some internists and family physicians and did not have to be necessarily coordinated with the dialysis centers. While currently most were given by these centers the trend was to move the injection to the clinics and no doubt once O is retuned to the market that trend will continue.
3-The number of deaths....continued
For those that follow this board they know that I posted my point of view here a few days after O was pulled and only after giving it much thought and looking at everything I could put my hands on.
This is my second note here. As I had mentioned before it is clear to me, and any experienced person in the medical field, that O as manufactured for the first 25000 patients and first 11 months of use is in NO WAY responsible for those reactions and deaths.
Put another way, you SIMPLY CAN'T NOT HAVE A MEDICATION THAT IS WORKED FOR SO MANY (25000) AND OVER SUCH A PROTRACTED TIME (11 MONTHS) SUDDENLY CAUSE ALL THOSE ALLERGIC REACTIONS.
THAT IS SIMPLY NOT THE WAY MEDICATIONS WORK.
Like I had mentioned something else much of gone wrong but that the original O and as it was originally manufactured is FINE and I feel today's stock move VINDICATES that VERY OBVIOUS point of view.
As it stands the only question at this time is when (and NOT whether) O will return to market and how long before pps returns to previous levels. MY view is that because of what mentioned above I would expect O to return to market within weeks if not days and pps will return to previous levels in short order. I actually think pps will surpass previous highs for simple reason that many doctors have become more familiar with O because of what is happened and once they know FDA is okeyed it back to market many will get on the band wagon of using it.
Sentiment: Strong Buy
It seems all the death happened in a single month from what I've read. This alone tells me there is no problem with the Omontys. Period.
there may have been problem with manufacturing of the product for that particular month, the administration of the iv in terms of the dose or how it was given, the effected patients co-mobidities or allergies, other medication or fluids administered at the same time, whether dialysis itself was the issue (for those on dialysis on the same day), etc etc etc.
But to repeat, there is NO WAY IN THE WORLD that OMONTYS as originally manufactured, could have been the cause as you could not possibly have had nearly 11 months and 25000 patients usage without any significant deviation from what is expected and then suddenly have get 3 deaths and many more anaphylactic
Note: I am a practicing physician nearing my retirement. I am also long AFFY as of this week.