On Wednesday, July 27th, 2011, the New York Times reported that allies of the medical device industry were waging an extraordinary campaign to discredit an upcoming report by one of the country's pre-eminent scientific groups that is examining possible new regulations on the industry. As of this posting, the report was released on Friday by the Institute of Medicine (IOM). The report's recommendation is to "scrap" the current system, which elicited reactions from outright rejection by industry officials, to acceptance by patients groups and disbelief from federal regulators, who had commissioned the report. The report was commissioned by everyone's best friend the Food and Drug Administration on the heels of recent recalls pertaining to metal-on-metal hips, pumps and defibrillators.
The Institute of Medicine is part of the National Academy of Sciences, a widely respected organization. The report goes on to say that it is not immediately clear as to what impact, if any, this report will have, or if it would be adopted. Industry dissenters included Medtronic, Boston Scientific and Johnson & Johnson. The mouthpiece for the industry, AdvaMed, immediately weighed in issuing a statement from Stephen J. Ubl, that "this would be a disservice to patients and the public health." Patient groups and some doctors applauded the panels findings, urging to create a system that examined a device's benefits and harms before patients were exposed to it. On the other hand, FDA officials were caught off guard.
The study in question reviewed the 501(k) clearance process under which moderate risk products are approved by the FDA. The study DID NOT examine devices that carry the highest risk to patients if they fail. The study concluded that the 510(k) process lacks the legal basis to be a reliable pre-market screen of the safety and effectiveness of moderate risk devices. The FDA's immediate response was that it believes that the 501(k) process should not be eliminated but is open to new proposals and approaches in its responsibility as the gatekeeper for device reviews.
As an unknown observer mentioned, "the first commandment of medicine is to protect the consumer from harm." But what does this say about our value system? The companies that immediately reacted to this study, have themselves been culpable of numerous recalls. The Washington Legal Foundation, whose tag line is "Advocate for Freedom and Justice," had fired a preemptive salvo on June 28th, 2011 urging the FDA not to use any advice or recommendations provided by the IOM, claiming violation of the Federal Advisory Committee Act. The brief was filed with pro bono assistance from Robert Klepinski, an attorney from Minneapolis, Minnesota. Mr. Klepinski is an attorney who counsels pharmaceutical, medical device and biotech companies on FDA policy, in addition to once working for Medtronic as a regulatory attorney.
With the recent controversy swirling around metal-on-metal hips like the DePuy ASR and ASR XL, and the Zimmer Durom Cup, could these scenarios be another example of profits taking precedence over science and technology? Interestingly, some other industry websites even have links to law firms that are looking for patients interested in participating in class action lawsuits against some of these companies. So the complex question must be asked of our readers, how does the industry find a balance between corporate sponsorship and science? Regardless, the fact remains that without clinicians working with companies, and private investment, innovation and technological improvements cease. And what happens to the patient if government regulations are bought and paid for by corporate interests?
The medical device court of public opinion is waning. The behavior of the insurance industry, a shell game at its best, and the recent public slaughtering of the device industry in the national press has made it evident that the integrity of the U.S.healthcare and medical device industry is under siege. Whether our bloggers agree to disagree, the fact remains that those companies that are publicly traded have become slaves to their master, the Street. What does it say about the medical community when there is such a dichotomy in principles? Whom does one believe? The unfortunate aspect of this debate is that there are companies that abide by the rules, and companies that know that the risks are outweighed by the potential profits. It all comes down to a cost-benefit analysis. Could it be cheaper to incur the fine or settle a legal claim than it is to properly evaluate the safety and efficacy of a new technology? Let's be honest, we're all in this to make money, but we're also in this to make the best products that money can buy without compromising the patient's safety. The current system is not sustainable. As companies cry out for additional self-regulation, have we learned anything from the most recent crisis in the financial community? The key to our survival is finding balance and reason in the regulatory oversight process, until then, thrive to survive.
Saturday, July 30, 2011
Tuesday, July 26, 2011
Storm Warning
On June 23, 2011 the FDA issued a warning letter to Pamela Layton, CEO of Parcell Laboratories in Newton, Massachusetts regarding their methods for processing the Alphatec PureGen Osteoprogenitor Cell Allograft. The inspectional records that were reviewed were standard operating procedure by the FDA, including product summaries, instruction for use, medical and health history profiles, donor physical assesments, viral test results, fungal test results, sterility, eligible donor files, and ineligible donor files. PureGen is intended for homologous use, meaning, to repair, replace or supplement a recipient's cells or tissue with an HCT/P (Human Cellular and Tissue/Products) that performs the same basic function in the recipient as it did in the donor. PureGen is intended to be used for homologous repair, replacement, and reconstruction for musculoskeletal defects, and is not to be used systemically.
Basically what the FDA was saying was that the ELA cells do not meet the criteria in 21 CFR Part 1271 which states that the purpose of this part is to create a unified registration and listing system for establishments that manufacture human cells, tissues, and cellular and tissue based products and to establish donor eligibility, current good tissue practice, and other procedures to prevent the introduction, transmission, and spread of communicable disease by the HCT/P.
If you are an establishment that manufactures HCT/P that are regulated solely under the authority of Section 361 of the PHS Act, this part requires that you register and list your HCT/P's with the FDA's Center for Biologics Evaluation and Research and to comply with the other requirements contained in this part, whether or not the HCT/P's enters into interstate commerce. The HCT/P's that are regulated solely under the authority of Section 361 of the PHS Act.
The HCT/P's must meet the following criteria:
The HCT/P's are minimally manipulated, they are intended for homologous use, reflected by the labeling or other indications of the manufacturer's intent. The HCT/P's do not involve the combination of cells or tissues with another article, except for water, crystalloids, or a sterilizing or preserving agent, providing these agents do not raise new clinical safety concerns.
The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary funcition or the HCT/P's have a systemic effect dependent upon the metabolic activity of living cells.
The HCT/P's are intended for autologous use, is for allogeneic use in 1st or 2nd degree blood relative, is for reproductive use, and if you are a domestic or foreign establishment that manufactures an HCT/P as described you must register with the FDA, you must submit to the FDA a list of each HCT/P manufactured and you must comply with other requirements. Specifically what this letter states is that the product does not meet the criterion in 21 CFR 1271.10(a)(4)(ii)(b) because the product is dependent on the metabolic activity of living cells for its primary function and is not intended for autologous use or allogenic use in a first or second degree blood relative. As a result your ELA cells are drugs under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the ACt) [21 U.S.C. 321 (g)] and biological products as defined in section 351(i) of the PHS Act [42 U.S.C.262 (i)].
The letter goes on to state in order to introduce or deliver for introduction a drug that is also a biologic product into interstate commerce, there must be a valid biologics license. The license is only issued after there is a showing of safety and efficacy for the products intended use. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an Investigational New Drug application in effect as specified by FDA regulations. PureGen OCA is not the subject of an approved biologics license application nor is there an IND in effect. Based on this information, the FDA has determined that your actions violated the ACT and the PHS Act.
Could the potential exist that the parties involved were going for an easier approval process, you be the Judge and the Jury. TSB wants to know what our bloggers think?
Basically what the FDA was saying was that the ELA cells do not meet the criteria in 21 CFR Part 1271 which states that the purpose of this part is to create a unified registration and listing system for establishments that manufacture human cells, tissues, and cellular and tissue based products and to establish donor eligibility, current good tissue practice, and other procedures to prevent the introduction, transmission, and spread of communicable disease by the HCT/P.
If you are an establishment that manufactures HCT/P that are regulated solely under the authority of Section 361 of the PHS Act, this part requires that you register and list your HCT/P's with the FDA's Center for Biologics Evaluation and Research and to comply with the other requirements contained in this part, whether or not the HCT/P's enters into interstate commerce. The HCT/P's that are regulated solely under the authority of Section 361 of the PHS Act.
The HCT/P's must meet the following criteria:
The HCT/P's are minimally manipulated, they are intended for homologous use, reflected by the labeling or other indications of the manufacturer's intent. The HCT/P's do not involve the combination of cells or tissues with another article, except for water, crystalloids, or a sterilizing or preserving agent, providing these agents do not raise new clinical safety concerns.
The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary funcition or the HCT/P's have a systemic effect dependent upon the metabolic activity of living cells.
The HCT/P's are intended for autologous use, is for allogeneic use in 1st or 2nd degree blood relative, is for reproductive use, and if you are a domestic or foreign establishment that manufactures an HCT/P as described you must register with the FDA, you must submit to the FDA a list of each HCT/P manufactured and you must comply with other requirements. Specifically what this letter states is that the product does not meet the criterion in 21 CFR 1271.10(a)(4)(ii)(b) because the product is dependent on the metabolic activity of living cells for its primary function and is not intended for autologous use or allogenic use in a first or second degree blood relative. As a result your ELA cells are drugs under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the ACt) [21 U.S.C. 321 (g)] and biological products as defined in section 351(i) of the PHS Act [42 U.S.C.262 (i)].
The letter goes on to state in order to introduce or deliver for introduction a drug that is also a biologic product into interstate commerce, there must be a valid biologics license. The license is only issued after there is a showing of safety and efficacy for the products intended use. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an Investigational New Drug application in effect as specified by FDA regulations. PureGen OCA is not the subject of an approved biologics license application nor is there an IND in effect. Based on this information, the FDA has determined that your actions violated the ACT and the PHS Act.
Could the potential exist that the parties involved were going for an easier approval process, you be the Judge and the Jury. TSB wants to know what our bloggers think?
Monday, July 25, 2011
Synthes v. Globus (Round 2)
Sooner than later, our readers are going to witness the most anticipated boxing match in the history of spine, for the heavyweight championship of the world. Are you ready? Spineblogger fans are you rrrrrrrrrrrready? With thousands of spinebloggers and millions of viewers watching in the United States of America, especially in the U.S. District Court of Delaware, "Let's get ready to rumble!" No fellow bloggers it not TSB, it's Philadelphia, Pennsylvania's favorite son, Michael Buffer standing in the ring holding the microphone with Synthes USA standing in one corner, while Globus Medical stands on the opposite side of the ring.
On Friday, July 22nd, 2011 the firm of Young, Conaway, Stargatt and Taylor LLP filed a formal complaint on behalf of Synthes USA in the U.S. District Court of Delaware against Globus Medical for infringing on Patent numbers 7,846,207, 7,862,616 and 7,875,076 also know as the "207," "616," and "076" patents which have been assigned to Synthes. This action arises under the patent laws of the U.S., 35 U.S.C., Sec 1, et seq.
The "207, 616, and 076" patents were duly and lawfully issued to Synthes by the USPTO. The Inventors of the "207 and 616" patents were Mssrs. Beat Lechmann, Dominique Burkard, Chris M.J. Cain, and Claude Mathieu, while the "076" patent was invented by Mssrs. Claude Mathier, John Cain, and Christopher Marden.
The Synthes complaints cites that Globus has directly infringed on these patents by making, using and offering for sale products that infringe on these patents. Included are the ALIF System Coalition, ACDF System and the InterContinental Place Spacer Products. The complaint states that Globus' infringement on these patents was willful. Synthes respectfully is asking the Court to enter judgement in its favor and against Globus and grant the following relief;
A judgement that Globus willfully infringed on the patents
Enjoining Globus and all persons in active concert from any further infringement
Award Synthes damages adequate to compensate for Globus' infringement
Award Synthes its attorney fees and costs
An order to recall from distribution and destroy its entire stock.
TSB wants to know who are you placing your bets on the Synthes "the Bone Crusher" USA or Globus "the Ironman" Medical? It doesn't get any better than this, these are two companies that will forever be tied to one another whether they really like it or not. Let's get ready to rumble!
On Friday, July 22nd, 2011 the firm of Young, Conaway, Stargatt and Taylor LLP filed a formal complaint on behalf of Synthes USA in the U.S. District Court of Delaware against Globus Medical for infringing on Patent numbers 7,846,207, 7,862,616 and 7,875,076 also know as the "207," "616," and "076" patents which have been assigned to Synthes. This action arises under the patent laws of the U.S., 35 U.S.C., Sec 1, et seq.
The "207, 616, and 076" patents were duly and lawfully issued to Synthes by the USPTO. The Inventors of the "207 and 616" patents were Mssrs. Beat Lechmann, Dominique Burkard, Chris M.J. Cain, and Claude Mathieu, while the "076" patent was invented by Mssrs. Claude Mathier, John Cain, and Christopher Marden.
The Synthes complaints cites that Globus has directly infringed on these patents by making, using and offering for sale products that infringe on these patents. Included are the ALIF System Coalition, ACDF System and the InterContinental Place Spacer Products. The complaint states that Globus' infringement on these patents was willful. Synthes respectfully is asking the Court to enter judgement in its favor and against Globus and grant the following relief;
A judgement that Globus willfully infringed on the patents
Enjoining Globus and all persons in active concert from any further infringement
Award Synthes damages adequate to compensate for Globus' infringement
Award Synthes its attorney fees and costs
An order to recall from distribution and destroy its entire stock.
TSB wants to know who are you placing your bets on the Synthes "the Bone Crusher" USA or Globus "the Ironman" Medical? It doesn't get any better than this, these are two companies that will forever be tied to one another whether they really like it or not. Let's get ready to rumble!
Sunday, July 24, 2011
Sunday Funnies
Picture a man or a woman going on a journey beyond sight and sound, they have entered TSB zone. Good day Spine World, you know what the late James Brown sang, "I feel good." It's time to rock it out from Baghdad to Berkeley. It's 0800 and TSB is ready to rock, the "0" stands for OH My God, have any of you read the most recent marketing reports for the spine world? You know the reports that tell you what you already know. Let's see, these reports have been uplinked and downloaded, inputted and outsourced, upsized and downsized, downsided and upgraded, they have been interfaced with a database, and their datebase is from cyberspace, they are interactive and hyperactive and from time to time they are radioactive. With that said the market has been inspected, detected, injected, but not perfected.
So what are the sages of the industry telling us? Well before you consider spending any of those fast depreciating good old U.S. dollars on another insane marketing report that tell you where you are (we know that), where you came from (we know that), let's take a look at what their crystal balls (no pun intended, not) are telling us where they see us going. By the way, if their predications for the future are wrong, do we get a refund with interest? The last few years in spine have been a rude awakening, mercenary to say the least. We have gone from a super sized industry to one that is slowly consolidating itself whether by acquisition or failure. Industry dynamics have been affected by a sagging U.S. economy, leading companies and investors to expand into markets outside the U.S., as well as selectively investing in technologies that are considered innovative. Only a higher authority knows what will happen to our economy if the U.S. Government defaults on the debt ceiling. The failure of our elected officials in both parties to resolute the debt could result in an economic downturn that could be the death knell for some spine companies. So where do we go from here?
TSB would like to share with our bloggers some facts about 2010. Our total market output was slightly over $7 billion dollars. Revenues were a slight increase of 2.2 percent over 2009. Poor growth considering where we came from. Medtronic continues to lead the pack as the market leader with roughly a 35% marketshare. Even with the acquisition of Synthes, J&J/DePuy ( a combined 26%) still takes a back seat to the Boys in Blue, followed by Stryker at 8%, NuVa at 5%, Globus at 3% and Zimmer at 3%. Before anyone gets their panties in a knot, these are rounded figures. The rest of the industry is battling for 20% of the pie. The key players in that bracket are Alphatec and Orthofix. Word on the Street is that this could be the year of Globus, and TSB is not predicting an IPO. Rumor has it that their XLiF device will give NuVA a run for its money, and if it is as good as some clinicians have said, could this be the beginning of the end for NuVasive as the King of the XLiF. This could be trouble for the Billion Dollar Baby.
Fusion continues to dominate, as we witness more entrants into the pedicle screw, cervical plate and PEEK interbody markets and biologic markets. One must ask, but why? A premium is being placed by some companies on simplifying surgical technique with new approaches to old systems. If you already have a viable and competitive system that has MIS capabilities, why does the industry need more fusion products? Simply, because new companies or those in the 20% of the pie, are willing to cut out the middleman and make direct deals with POD's, a new breed of brokers and hospitals. What we are learning in 2011 is that the key to success has been creative and innovative selling techniques, along with attractive/aggressive commission programs to offset the increase in insurance denials and an outright attack by hospitals on driving ASP's to all time lows. Companies that have been able to pick off distributors that were collateral damage in the Apatech/ Baxter, and Stryker/Orthovita acquisitions increased their revenues. These were the outliers in the industry. The pending J&J/Synthes integration will also result in a shift in market share, the question is, who will be the lucky company or companies to capitalize on this integration? It will be impossible to keep everyone in the fold as there will be overlap in the field resulting in more industry related layoffs.
TSB believes that any company that doesn't have some type of motion preservation technology is already behind the eight ball. There are roughly 30-35 companies with a variety of cervical disc devices and 25 companies with lumbar platforms. As far as the Dynamic Stabilization market is concerned, remember that old French expression, "Le Roi est mort, Vive Le Roi." Unfortunately, TSB does not see a successor, resulting in an interregnum for Dynamic Stabilization, along with the fact that the FDA has placed greater scrutiny on this product line. Companies with ISD's could end up being the big winners in 2012 considering that they are playing in a diminishing landscape. The advantages of this procedure are a shorter surgical time, involving a minimally invasive approach that is low-risk that results in patients recovering much needed flexibility and mobility. Products like Axle, Coflex, X-Stop (the grand dame of ISD's), Superion, Flexus, In-Space, Spinos, Gel-Fix, Spinos, ISS, DynaFix, and Primalok are viable treatment modalities when it comes to Grade I spondy's with assoicated spinal stenosis. The market and surgeons will determine who are the winners and who are the losers, as usual it comes down to simplicity and instrumentation. The challenge will be to get those devices in IDE's out quickly, so that hospitals welcome them with open arms. Reimbursement is an invitation to the party.
If the future calls for an estimated annual growth of 3-5% over the next five, the companies with innovation will win the race, but it will be a marathon rather than a sprint? Will the top five companies be able to sustain their positions? Will stem cells rule the biologics marketplace? Will someone be displaced by an up and coming company. Will someone like Zimmer attempt to correct its past indiscretions in spine by making a key acquisition, or, will they be displaced by one of those companies in the 20% part of the pie? Whatever the outcome, strap yourselves in for the ride because 2012 will be the year of the dragon, one with vitality and strength. The only question that remains to be answered is will it be the U.S. market that produces vitality or markets outside the U.S. when it comes to spine? TSB wants to know what our readers think?
So what are the sages of the industry telling us? Well before you consider spending any of those fast depreciating good old U.S. dollars on another insane marketing report that tell you where you are (we know that), where you came from (we know that), let's take a look at what their crystal balls (no pun intended, not) are telling us where they see us going. By the way, if their predications for the future are wrong, do we get a refund with interest? The last few years in spine have been a rude awakening, mercenary to say the least. We have gone from a super sized industry to one that is slowly consolidating itself whether by acquisition or failure. Industry dynamics have been affected by a sagging U.S. economy, leading companies and investors to expand into markets outside the U.S., as well as selectively investing in technologies that are considered innovative. Only a higher authority knows what will happen to our economy if the U.S. Government defaults on the debt ceiling. The failure of our elected officials in both parties to resolute the debt could result in an economic downturn that could be the death knell for some spine companies. So where do we go from here?
TSB would like to share with our bloggers some facts about 2010. Our total market output was slightly over $7 billion dollars. Revenues were a slight increase of 2.2 percent over 2009. Poor growth considering where we came from. Medtronic continues to lead the pack as the market leader with roughly a 35% marketshare. Even with the acquisition of Synthes, J&J/DePuy ( a combined 26%) still takes a back seat to the Boys in Blue, followed by Stryker at 8%, NuVa at 5%, Globus at 3% and Zimmer at 3%. Before anyone gets their panties in a knot, these are rounded figures. The rest of the industry is battling for 20% of the pie. The key players in that bracket are Alphatec and Orthofix. Word on the Street is that this could be the year of Globus, and TSB is not predicting an IPO. Rumor has it that their XLiF device will give NuVA a run for its money, and if it is as good as some clinicians have said, could this be the beginning of the end for NuVasive as the King of the XLiF. This could be trouble for the Billion Dollar Baby.
Fusion continues to dominate, as we witness more entrants into the pedicle screw, cervical plate and PEEK interbody markets and biologic markets. One must ask, but why? A premium is being placed by some companies on simplifying surgical technique with new approaches to old systems. If you already have a viable and competitive system that has MIS capabilities, why does the industry need more fusion products? Simply, because new companies or those in the 20% of the pie, are willing to cut out the middleman and make direct deals with POD's, a new breed of brokers and hospitals. What we are learning in 2011 is that the key to success has been creative and innovative selling techniques, along with attractive/aggressive commission programs to offset the increase in insurance denials and an outright attack by hospitals on driving ASP's to all time lows. Companies that have been able to pick off distributors that were collateral damage in the Apatech/ Baxter, and Stryker/Orthovita acquisitions increased their revenues. These were the outliers in the industry. The pending J&J/Synthes integration will also result in a shift in market share, the question is, who will be the lucky company or companies to capitalize on this integration? It will be impossible to keep everyone in the fold as there will be overlap in the field resulting in more industry related layoffs.
TSB believes that any company that doesn't have some type of motion preservation technology is already behind the eight ball. There are roughly 30-35 companies with a variety of cervical disc devices and 25 companies with lumbar platforms. As far as the Dynamic Stabilization market is concerned, remember that old French expression, "Le Roi est mort, Vive Le Roi." Unfortunately, TSB does not see a successor, resulting in an interregnum for Dynamic Stabilization, along with the fact that the FDA has placed greater scrutiny on this product line. Companies with ISD's could end up being the big winners in 2012 considering that they are playing in a diminishing landscape. The advantages of this procedure are a shorter surgical time, involving a minimally invasive approach that is low-risk that results in patients recovering much needed flexibility and mobility. Products like Axle, Coflex, X-Stop (the grand dame of ISD's), Superion, Flexus, In-Space, Spinos, Gel-Fix, Spinos, ISS, DynaFix, and Primalok are viable treatment modalities when it comes to Grade I spondy's with assoicated spinal stenosis. The market and surgeons will determine who are the winners and who are the losers, as usual it comes down to simplicity and instrumentation. The challenge will be to get those devices in IDE's out quickly, so that hospitals welcome them with open arms. Reimbursement is an invitation to the party.
If the future calls for an estimated annual growth of 3-5% over the next five, the companies with innovation will win the race, but it will be a marathon rather than a sprint? Will the top five companies be able to sustain their positions? Will stem cells rule the biologics marketplace? Will someone be displaced by an up and coming company. Will someone like Zimmer attempt to correct its past indiscretions in spine by making a key acquisition, or, will they be displaced by one of those companies in the 20% part of the pie? Whatever the outcome, strap yourselves in for the ride because 2012 will be the year of the dragon, one with vitality and strength. The only question that remains to be answered is will it be the U.S. market that produces vitality or markets outside the U.S. when it comes to spine? TSB wants to know what our readers think?
Tuesday, July 19, 2011
Pay Me Now, Pay Me Later, But Someone Has To Pay
Recently one of our fellow bloggers inquired whether TSB could pen-a-post regarding the current state of the insurance industry, and how it relates to an increase in spine procedure denials. Supposedly, there has been an influx of denials in the Sunshine State. Low back pain has been one of the greatest challenges for the patient, spine surgeon and the insurance industry. It is a given fact that back pain is one of the most expensive ailments to treat. You don't need another data base to verify this fact. Considering that spinal fusions have increased dramatically over the past ten years, its a wonder why insurance companies are placing greater scrutiny on lumbar fusions, or lumbar related procedures. The question must be asked, what is reasonable and what is unreasonable when it comes to surgical intervention? The argument can be made that it is difficult to measure instability in certain clinical circumstances. As insurance companies look to push the envelop on denying coverage, a greater onus is being placed on both companies and surgeons to establish a more defined criteria. If conservative management was a panacea, why would anyone need back surgery? Physical Therapy, NSAID"s, and epidural relief are far less expensive than surgery. Is there a magic bullet in determining whether a patient will have an excellent outcome without the obvious factors that contribute to poor prognoses? Why do some patients do better than others? Because at the end of the day, isn't it really about the outcomes? Could part of the challenge be that the definition of instability is not uniform in acceptance? At best, the studies that exist have provided mixed outcomes. As insurance companies continue to scrutinize spine surgery, they have negotiated with the surgical community by allowing respective spine societies to comment on their concerns, and even influence and modify coverage, witnessed by the recent lumbar procedures taken hostage in the BCBS of North Carolina standoff with SAS, NASS, and AANS. Does this bode well for the industry?
In order to obtain more comprehensive data, spine companies will have to work closer with payers, witnessed by NuVasive's pro-active position with XLiF, and surgical societies must be willing to provide greater detail in how their outcomes are measured. Most patients present with degenerative disc disease (DDD), if the pain generator is not primary, then the challenge is to quantify the secondary and/or tertiary pain generators. If conservative therapy does not help the patient, the surgeon and patient collaborate to operate. So why do insurance companies behave the way that they do? Simply stated, it's their job. As has been stated on this blog, and at many industry related forums, the insurance industry is about risk management. Insurance companies view spine surgery as potential risk by calculating the probability of an adverse event, the surgery, they estimate the financial impact, how much will it cost and look to minimize their loss. That's why data is imperative. They are no different than Goldman Sachs or Citigroup when it comes to managing their portfolio. What most people fail to understand or accept is that medical care is more art than science, everyone cannot always have a good result. But the reality is that for many years spine was a carte blanche procedure, and it was just a matter of time before it came under attack, so in closing TSB wants to know who has seen an increase in denials, what states have been effected, and is this an anomaly or truly a growing trend?
In order to obtain more comprehensive data, spine companies will have to work closer with payers, witnessed by NuVasive's pro-active position with XLiF, and surgical societies must be willing to provide greater detail in how their outcomes are measured. Most patients present with degenerative disc disease (DDD), if the pain generator is not primary, then the challenge is to quantify the secondary and/or tertiary pain generators. If conservative therapy does not help the patient, the surgeon and patient collaborate to operate. So why do insurance companies behave the way that they do? Simply stated, it's their job. As has been stated on this blog, and at many industry related forums, the insurance industry is about risk management. Insurance companies view spine surgery as potential risk by calculating the probability of an adverse event, the surgery, they estimate the financial impact, how much will it cost and look to minimize their loss. That's why data is imperative. They are no different than Goldman Sachs or Citigroup when it comes to managing their portfolio. What most people fail to understand or accept is that medical care is more art than science, everyone cannot always have a good result. But the reality is that for many years spine was a carte blanche procedure, and it was just a matter of time before it came under attack, so in closing TSB wants to know who has seen an increase in denials, what states have been effected, and is this an anomaly or truly a growing trend?
Thursday, July 14, 2011
The Spirit of Edgar Dawson, M.D..................Lives On
As the INFUSE debate escalates, TSB thought it would be of interest to our bloggers to revisit a 2003 Letter to the The Spine Journal Editor by Edgar Dawson, M.D.. Dr. Dawson contributions to spine surgery was immense. An academician, Dr. Dawson's love of medicine was something to envy. In 2003, Dr. Dawson's letter addressed many of the concerns that have surrounded the recent INFUSE debate.
Dr. Dawson believed that the FDA approval of Bone Morphogenic Proteins was an important milestone in orthopaedic science, yet, he warned that it was time to pause and examine unresolved issues so as not to misuse a clinical treatment modality in "its infancy" despite over three decades of research. Contrary to some peoples opinions, Zdeblick, Burkus and Haid were not the founding founders of BMP , Dr. Mashall Urist, M.D., pioneered studies on bone induction and the identification of bone morphogenic proteins. He revolutionized the field of orthopaedic growth factors. A little history will educate some of our younger bloggers. But back to Dr. Dawson.
In the Letter to the Editor, Dr. Dawson warned that clinical results had not been as conclusive as pre-clinical results. The key to his observations were that carefully designed and well controlled trials yielded much different results than an uncontrolled environment. The preclinical and clinical studies of BMP's may not be as simple as differences in the healing potential of young healthy lab animals compared with human subjects. The key to Dawson's then letter was that "no dosing data was available from an actual clinical study." If ever there was a prophetic observation, Dawson warned that, "different indications will require not only different doses of proteins but potentially different carrier materials to obtain clinical efficacy." The argument can be made by those in the surgical community that it has been proven that the use of BMP-2 in posterolateral fusions has been efficacious, and rightfully so, but the question remains, how many post-op issues have never been reported or addressed? Just eight years ago, prior to his death, Dawson warned that "the use of BMP's are not without potential significant complications." The Marshall Urist's and Edgar Dawson's of the world were not only pioneers, they envisioned the potential side effects of a powerful therapeutic agent. They discussed the importance of containment at the site from their experience with exuberant bone formation in the soft tissues in animal studies.
One of the unknown risks that Dawson discussed was the role of antibodies that develop to BMP's in some patients post-op. Though the occurrence rate was higher for BMP-7, anti-body formation was reported to a lesser degree in patients that receive BMP-2. In 1985 Urist, Hudak, Huo, and Rasmussen published a paper entitled, "Osteoporosis: A Bone Morphogenic Protein Auto-Immune Disorder," citing increased levels of antibodies to BMP's in patients with osteoporosis, speculating that osteoporosis may be a BMP auto-immune disorder. In addition, BMP was contraindicated for pregnant women, and women were advised to use contraception for at least one year after implantation of BMP. Finally, as Dawson writes, BMP's have been isolated and identified in osteosarcomas.
Since the time of Dawson's death, the medical community has learned much more about the effects of dosing and containment, yet the cost effectiveness, the limitations, and potential complications must continue to be explored and documented in a transparent way for the safety of the patient first, and profits second. Sometimes people get those two things mixed up. But as Dawson points out, surgeons should never forget the basic principles of bone healing and biology, or as many of our bloggers know, it comes down to carpentry and craftsmanship and therein may lie the problem. The use of BMP was never intended for convenience, or as another short cut to getting great results. It all comes down to process, which includes meticulous graft site preparation and understanding how to deliver/dose this product. Too many people fail to understand process because all they care about is results. In closing, Dawson's prophecy is still with us whether we like it or not, the question is have we learned anything?
Dr. Dawson believed that the FDA approval of Bone Morphogenic Proteins was an important milestone in orthopaedic science, yet, he warned that it was time to pause and examine unresolved issues so as not to misuse a clinical treatment modality in "its infancy" despite over three decades of research. Contrary to some peoples opinions, Zdeblick, Burkus and Haid were not the founding founders of BMP , Dr. Mashall Urist, M.D., pioneered studies on bone induction and the identification of bone morphogenic proteins. He revolutionized the field of orthopaedic growth factors. A little history will educate some of our younger bloggers. But back to Dr. Dawson.
In the Letter to the Editor, Dr. Dawson warned that clinical results had not been as conclusive as pre-clinical results. The key to his observations were that carefully designed and well controlled trials yielded much different results than an uncontrolled environment. The preclinical and clinical studies of BMP's may not be as simple as differences in the healing potential of young healthy lab animals compared with human subjects. The key to Dawson's then letter was that "no dosing data was available from an actual clinical study." If ever there was a prophetic observation, Dawson warned that, "different indications will require not only different doses of proteins but potentially different carrier materials to obtain clinical efficacy." The argument can be made by those in the surgical community that it has been proven that the use of BMP-2 in posterolateral fusions has been efficacious, and rightfully so, but the question remains, how many post-op issues have never been reported or addressed? Just eight years ago, prior to his death, Dawson warned that "the use of BMP's are not without potential significant complications." The Marshall Urist's and Edgar Dawson's of the world were not only pioneers, they envisioned the potential side effects of a powerful therapeutic agent. They discussed the importance of containment at the site from their experience with exuberant bone formation in the soft tissues in animal studies.
One of the unknown risks that Dawson discussed was the role of antibodies that develop to BMP's in some patients post-op. Though the occurrence rate was higher for BMP-7, anti-body formation was reported to a lesser degree in patients that receive BMP-2. In 1985 Urist, Hudak, Huo, and Rasmussen published a paper entitled, "Osteoporosis: A Bone Morphogenic Protein Auto-Immune Disorder," citing increased levels of antibodies to BMP's in patients with osteoporosis, speculating that osteoporosis may be a BMP auto-immune disorder. In addition, BMP was contraindicated for pregnant women, and women were advised to use contraception for at least one year after implantation of BMP. Finally, as Dawson writes, BMP's have been isolated and identified in osteosarcomas.
Since the time of Dawson's death, the medical community has learned much more about the effects of dosing and containment, yet the cost effectiveness, the limitations, and potential complications must continue to be explored and documented in a transparent way for the safety of the patient first, and profits second. Sometimes people get those two things mixed up. But as Dawson points out, surgeons should never forget the basic principles of bone healing and biology, or as many of our bloggers know, it comes down to carpentry and craftsmanship and therein may lie the problem. The use of BMP was never intended for convenience, or as another short cut to getting great results. It all comes down to process, which includes meticulous graft site preparation and understanding how to deliver/dose this product. Too many people fail to understand process because all they care about is results. In closing, Dawson's prophecy is still with us whether we like it or not, the question is have we learned anything?
Tuesday, July 12, 2011
Summertime Blues
The last few weeks in spine have been interesting, to say the least. Without questions surrounding INFUSE, and a bit of hoopla regarding the acquisition of Salient and PEAK by Medtronic, what would the industry really have to debate? Another story on stem cells? Another story on POD's? The same relentless blogger asking the ridiculous question, "when will Globus finally go public?" Would it be safe to say that spine has hit a wall? Or, could this be a pivotal and defining moment for the spine industry? Could the Dog Daze of Summer be lulling you the into a false sense of security? Could you be coming down with a case of the Summertime Blues? Or, has the industry continued to rear its ugly head by the way salespeople and surgeons have gone after one another, or, how The Spine Journal has now pitted surgeon against surgeon by dedicating an entire issue to INFUSE? I guess Medtronic's new CEO Ishrak is receiving his baptism under fire. The Korengal Valley rather than Minneapolis may be a better place to sequester oneself. Even Larry Biegelsen of Wells Fargo fame has weighed in with his analysis of what could potentially happen to Medtronic's Kingdom if his crystal ball allows him to look into the future. Someone recently asked TSB the question, why was this blog started? This blog was a response by a core group of people that have believed and echoed for years, the sentiment that this industry needed to develop a referendum on the way business is conducted, how scientific evidence is presented, and how unscrupulous our practices have become in a highly competitive and saturated spine marketplace. How many of you have sat in the audience during past clinical presentations on INFUSE snickering at the underlying commercialization of a product, wondering how long will the medical community tolerate this behavior until it calls out its own colleagues? Does anyone have any questions from the audience? How many times have you sat in the audience asking yourself is this a scientific presentation, or a sales pitch by Ron Popeil for the Ronco Rotisserie? Commercial interest from the podium, not in our industry, especially at an educational forum. TSB knows the actors that have the leading role in this movie. All of them are good men, but just because you have good intent, does not mean that your opinions can't be influenced by your vested or financial interest in a products success or failure. And yes fellow bloggers its okay if the authors of this paper intended to tie in one with the other, because at the end of the day human nature does play a role in science. Does anyone really believe that the intent of this paper was to bring Medtronic down? Absolutely not. Does anyone really believe that the intent of the paper was to embarrass Drs. Zdeblick, Burkus and Haid? Highly unlikely. Maybe the authors are just asking their peers and the industry for transparency. Contrary to prevailing opinions, Medtronic and INFUSE are not going away anytime soon. Is this the wake call that Medtronic desperately needed to regroup? Maybe they will realize that its not all about shareholder value, return on investment, and how many consultants can you have in your pocket? Maybe the company needs to get back to basics? Regardless, Mr. Ishrak must now deal with the fact that his company's reputation has become stale because of their arrogance.
The Spine Journal addresses the core problem of our industry, the spine community behaves like their is no systemic problem. To paraphrase an industry platform, "the spine community is reeling, even accusing the authors of tabloid sensationalism." Surgeons like Carragee, Weiner, Rothman, Bono and Ghanayem are questioning INTEGRITY, HONESTY, ETHICS, and CONFLICT OF INTEREST? Today, they ask questions that should have been asked many years ago. Unfortunately, the medical profession frowns anyone that challenges a prevailing opinion even if it pertains to the so-called new savior in spine fusion. Yes INFUSE has done wonderful things for patients, but it has also been utilized in ways that it was never intended to be utilized, and that's where the problems exist. Even Zdeblick alludes to that. Whether you like it or not, its a drug. It was developed by a pharmaceutical company, Wyeth, licensed to Medtronic and positioned as the panacea for all fusions. If surgeons are expressing their anger, they should be angry at themselves for failing to ask the necessary questions years ago when the opportunity presented itself. TSB wants to know what our readers think, will Medtronic rebound or will they take the hit from the piranha's circling the waters. Everyone knows that anyone with stem cells, or any other biologic are just chomping at the bit.
Thursday, July 7, 2011
Network: 1976 Redux? Have Things Really Changed?
TSB doesn't have to tell you things are bad. Everybody knows things are bad. People are out of work and scared of losing their jobs. The dollar doesn't buy you squat, spine companies have gone out of business, or have been merged, shopkeepers keep guns handy in event, spine sales people are running wild, and there's no one anywhere that knows what to do. The air is unfit to breathe, and food is unfit to eat. We sit at night watching the news and have some local newscaster tell us we had fifteen homicides and forty-one violent crimes, while the economy melts down, and Congress dicks around with the future of this country. We know things are bad, maybe worse than bad. No one wants to sell, no doctors wants to see your products, hospitals are building a moat around their complex to keep you out, insurance companies don't want to approve your surgery, and you can no longer play by the rules. Rules? What rules? Everything goes. It's like everything, everywhere is going crazy, so we don't really work that hard anymore. Just leave us alone.
Well you know what, TSB is not going to leave you alone. We want you to get mad. We don't want you to protest, you're a generation void of any social conscience, we don't want you to riot, you wouldn't be able to handle the mayhem, we don't want you to write your Congressman or Senator, because most of them are never at work. We don't know what to do about the depression, oh yes, by the way who ever came up with the "great recession," the Middle East, and crime in the streets. All we know is that it's time that you get mad. You've got to say, I'm a salesperson and I am not buying a doctors office lunch anymore. God damn it! My product has value and I am sick of feeding the herd at every surgeons office for the opportunity to genuflect, kiss the ring, and then get nothing more than lip service. We want you to get up, stop your cars, open your windows, and we want you to yell, "WE'RE MAD AS HELL AND WE'RE NOT GOING TO TAKE THIS ANYMORE." THINGS HAVE GOT TO CHANGE. There will be no more $300 dollar lunches, no feeding the herd. The doctor needs lunch? Buy him a sandwich, you're not selling to his staff. After you do that, then we'll figure out what to do with the debt ceiling, raising hedge fund managers taxes, and speculators playing with oil prices. But first you've got to say, "We're mad as hell and we're not going to take this anymore."
No fellow bloggers, it's not Howard Beale. Oh Howard, if only you were running Zimmer Spine or even Orthowreck. TSB is blogging in response to an e-mail that was received from a fellow salesperson regarding the absurdity of making a sales call and having to buy an entire office lunch for an opportunity to discuss one's product, and the potential of doing business. The result: "we have many hurdles to jump over before we can even consider using the product." WTF does that mean? Considering the price of gasoline, the cost of parking, and lunch, its a wonder that many of you are not out there making sales calls. C'mon, how many of you are really making sales calls? In all likelihood you are trying to sell between cases in the hospital where the surgeon has no time, unless of course he's your consultant, or best friend. Companies want you to sell their products and increase revenue, yet, they don't have marketing collaterals, launch products without ancillary instrumentation, and have unrealistic expectations for growth, just go and read another marketing report. The bottom line is if you really want to effect change, start out by boycotting the staff lunch. They might be nice people, but what do they have to do with buying the product, you, and the potential relationship that you may foster with a customer? If there ever was a place to start, now may be the time.
Well you know what, TSB is not going to leave you alone. We want you to get mad. We don't want you to protest, you're a generation void of any social conscience, we don't want you to riot, you wouldn't be able to handle the mayhem, we don't want you to write your Congressman or Senator, because most of them are never at work. We don't know what to do about the depression, oh yes, by the way who ever came up with the "great recession," the Middle East, and crime in the streets. All we know is that it's time that you get mad. You've got to say, I'm a salesperson and I am not buying a doctors office lunch anymore. God damn it! My product has value and I am sick of feeding the herd at every surgeons office for the opportunity to genuflect, kiss the ring, and then get nothing more than lip service. We want you to get up, stop your cars, open your windows, and we want you to yell, "WE'RE MAD AS HELL AND WE'RE NOT GOING TO TAKE THIS ANYMORE." THINGS HAVE GOT TO CHANGE. There will be no more $300 dollar lunches, no feeding the herd. The doctor needs lunch? Buy him a sandwich, you're not selling to his staff. After you do that, then we'll figure out what to do with the debt ceiling, raising hedge fund managers taxes, and speculators playing with oil prices. But first you've got to say, "We're mad as hell and we're not going to take this anymore."
No fellow bloggers, it's not Howard Beale. Oh Howard, if only you were running Zimmer Spine or even Orthowreck. TSB is blogging in response to an e-mail that was received from a fellow salesperson regarding the absurdity of making a sales call and having to buy an entire office lunch for an opportunity to discuss one's product, and the potential of doing business. The result: "we have many hurdles to jump over before we can even consider using the product." WTF does that mean? Considering the price of gasoline, the cost of parking, and lunch, its a wonder that many of you are not out there making sales calls. C'mon, how many of you are really making sales calls? In all likelihood you are trying to sell between cases in the hospital where the surgeon has no time, unless of course he's your consultant, or best friend. Companies want you to sell their products and increase revenue, yet, they don't have marketing collaterals, launch products without ancillary instrumentation, and have unrealistic expectations for growth, just go and read another marketing report. The bottom line is if you really want to effect change, start out by boycotting the staff lunch. They might be nice people, but what do they have to do with buying the product, you, and the potential relationship that you may foster with a customer? If there ever was a place to start, now may be the time.
Wednesday, July 6, 2011
The FDA's Gift of Giving
The last few weeks in spine has made it interesting to read everyone's comments regarding INFUSE. Your commentary has made TSB think about how truly gamed the system is by those spine/orthopedic companies that wield economic power in the industry. The principle behind any oligarchy is that economic power yields political clout and influence. The obvious companies come to mind, Medtronic, Johnson & Johnson/Synthes, Stryker, Zimmer, Biomet, Nuvasive (Billion Dollar Baby), Orthowreck, and Globus. Don't believe that? Just walk in a North American Spine Society Meeting. The big boys are situated right at the front entrance, while the ankle biters are hidden in the back near the restrooms, hoping that surgeons looking to relieve themselves will grace them with their presence. Our society cherishes the idea that all Americans have an equal opportunity to make money. A rich and privileged class of companies that have consistently used government relationships to enrich themselves in the best of times, and protect themselves in the worst, only to cry out for big government to stay out of their business. If one truly believes in "free-markets," one understands that our economic system was founded on the notion of fair competition in a free market. Most of these companies cry like an adolescent when it comes to being held accountable, in many respects believing that they should be treated like their Wall Street brethren, blaming the federal agencies for their inability to generate more revenue by placing restrictions and regulations on innovation, resulting in jobs being exported overseas, and crying for even more deregulation. Just like the housing market, the spine market is beginning to realize that the days of glory are gone, unless of course you are the industry's Maggie Fitzgerald and are selling futures to the analysts that your company will one day be a billion dollar baby.
So what's the gist of this post. Considering the rants regarding INFUSE, its clinical efficacy, and off-label use, no one has still answered the $1 million dollar per day question, did the FDA drop the ball on INFUSE, and were they pressured into making a decision that has potentially hurt a percentage of patients rather than make their lives better? Could someone at the FDA have been influenced by tried and true methods? Let's face facts, all we hear are the stories and papers that espouse the use of this pharmaceutical, but what about the horror stories? Many readers and platforms love to skewer the FDA, blaming them for the industry's inability to bring innovation to the marketplace, complaining that there needs to be a relaxing and restructuring of the submission process. But could this be a scenario where the FDA really failed at what its suppose to do best? Protect the public? Is the FDA looking out for our best interest? And, is it just the FDA, or, have the courts now set precedent?
In 2009, lawsuits on behalf of thousands of plaintiffs with Medtronic heart defibrillator wires, which have been known to be the "shittiest" in the industry and had been know to fracture and potentially send lethal shocks to patients, had been dismissed by U. S. District Judge Richard H. Kyle on the basis of the Preemptive Doctrine. Undoubtedly, Judge Kyle's background as a Minnesotan, nor, that his son's law firm had previously done work for Medtronic had nothing to do with his decision. The Preemptive Doctrine is based on the Supremacy Clause, which dictates that the federal government in exercising any of the powers enumerated in the Constitution, must prevail over any conflicting or inconsistent state exercise of power. Does the Preemptive Doctrine then open the door for more devices to slip through the system that are not ready for implantation? Maybe we should hook up Judge Kyle and his son to one of those defibs, just for shits and giggles to see if they like it? And then there is Wyeth. Wyeth sold the rights to BMP-2 to Medtronic. Will they be asked to testify and grace the Senate Finance chamber with their presence, knowledge, and experience on how this drug was originally intended for delivery and use? Wyeth could be the key in answering many open ended question about how this product should have been commercially brought to this market. Pure conjecture would say that Wyeth knows much more than anyone of us know.
So in closing, it will be interesting to see how long the Senate investigation will take. Will Ishrak call on his buddy Jeff Immelt to pull strings on Capitol Hill, while Medtronic continues to grease the wheels of the Congress and the Millionaires Club spending more money on lobbyists fighting their cause? And who has incurred the cost, or the wrath of the many revisions that took place due to INFUSE growing like wild fire? The taxpayer? All for the love of science and medicine, no doubt. Until then, Caveat Emptor.
So what's the gist of this post. Considering the rants regarding INFUSE, its clinical efficacy, and off-label use, no one has still answered the $1 million dollar per day question, did the FDA drop the ball on INFUSE, and were they pressured into making a decision that has potentially hurt a percentage of patients rather than make their lives better? Could someone at the FDA have been influenced by tried and true methods? Let's face facts, all we hear are the stories and papers that espouse the use of this pharmaceutical, but what about the horror stories? Many readers and platforms love to skewer the FDA, blaming them for the industry's inability to bring innovation to the marketplace, complaining that there needs to be a relaxing and restructuring of the submission process. But could this be a scenario where the FDA really failed at what its suppose to do best? Protect the public? Is the FDA looking out for our best interest? And, is it just the FDA, or, have the courts now set precedent?
In 2009, lawsuits on behalf of thousands of plaintiffs with Medtronic heart defibrillator wires, which have been known to be the "shittiest" in the industry and had been know to fracture and potentially send lethal shocks to patients, had been dismissed by U. S. District Judge Richard H. Kyle on the basis of the Preemptive Doctrine. Undoubtedly, Judge Kyle's background as a Minnesotan, nor, that his son's law firm had previously done work for Medtronic had nothing to do with his decision. The Preemptive Doctrine is based on the Supremacy Clause, which dictates that the federal government in exercising any of the powers enumerated in the Constitution, must prevail over any conflicting or inconsistent state exercise of power. Does the Preemptive Doctrine then open the door for more devices to slip through the system that are not ready for implantation? Maybe we should hook up Judge Kyle and his son to one of those defibs, just for shits and giggles to see if they like it? And then there is Wyeth. Wyeth sold the rights to BMP-2 to Medtronic. Will they be asked to testify and grace the Senate Finance chamber with their presence, knowledge, and experience on how this drug was originally intended for delivery and use? Wyeth could be the key in answering many open ended question about how this product should have been commercially brought to this market. Pure conjecture would say that Wyeth knows much more than anyone of us know.
So in closing, it will be interesting to see how long the Senate investigation will take. Will Ishrak call on his buddy Jeff Immelt to pull strings on Capitol Hill, while Medtronic continues to grease the wheels of the Congress and the Millionaires Club spending more money on lobbyists fighting their cause? And who has incurred the cost, or the wrath of the many revisions that took place due to INFUSE growing like wild fire? The taxpayer? All for the love of science and medicine, no doubt. Until then, Caveat Emptor.
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