Cyber Hacking and the Heart: How Science Fiction Becomes Science Fact, And How Profits Influence Policy

This week, the Food and Drug Administration (FDA) confirmed that pacemakers and implantable defibrillators (ICDs) manufactured by St Jude Medical are vulnerable to cyber hacking. This completes months of cooperative investigation and evaluation by the company and the FDA. An announcement was made on January 9, 2017 that Abbott—who recently acquired SJM in a deal reported to be worth 25 billion dollars—has provided a software patch as a “fix”. To date, the FDA has confirmed that no patients have been harmed by the vulnerabilities.

What Exactly IS the Security Issue?

Most implantable cardiac devices such as pacemakers and defibrillators (regardless of manufacturer) are now able to connect to home monitoring systems wirelessly so that physicians can monitor the devices remotely. These remote monitoring systems are essential in the long-term management of device patients. This technology allows healthcare providers to respond quickly to any device alerts, malfunctions or changes in a patient’s clinical status. All of these networks contain embedded computer systems that are connected to the internet and this makes them vulnerable to malicious cyber attacks and these vulnerabilities have been discussed since before 2013. All major manufacturers have these home transmitters and each differs in the exact frequency with which the transmitter communicates with the device. Previous research has shown that medical devices are vulnerable to hackers who were able to assume control of the device in a laboratory setting. In the case of the St Jude Medical devices, the FDA released their findings on security vulnerabilities in a safety report dated January 9, 2017. In the report, the FDA states that the agency “has reviewed information concerning potential cybersecurity vulnerabilities associated with St. Jude Medical’s Merlin@home Transmitter and has confirmed that these vulnerabilities, if exploited, could allow an unauthorized user, i.e., someone other than the patient’s physician, to remotely access a patient’s RF-enabled implanted cardiac device by altering the Merlin@home Transmitter.” According to the FDA, the issue at hand is that hackers could potentially access the Merlin@home transmitter and potentially reprogram the device or prematurely deplete the battery putting patients at significant risk. Based on the completed review, SJM (now Abbott) has released a software “patch” that was recently designed to address the vulnerabilites in the Merlin@home system. The patch will be automatically installed wirelessly over the internet in all home monitoring systems this week. The FDA will continue to monitor cyber security issues and advises both patients and physicians to continue to conduct home monitoring as per routine.

How and When Did This Come About? Follow the Money….

This story began in August 2016, when Muddy Waters Capital, a privately owned investment research firm, first suggested that these vulnerabilities existed and advised that they would be short selling the SJM stock. Muddy Waters, in turn, first learned about the cyber security issues concerning SJM devices from MedSec, an independent cyber security company. At the time, Med Sec claimed that their research suggested that St. Jude Medical was “by far the least secure” of the four largest implantable cardiac device makers in the United States. SJM responded by saying that the claims were “absolutely untrue” and that the Muddy Waters investigation was based entirely on “financial gain”.

In September public record indicated that SJM sued Muddy Waters—calling the short seller’s claims “irresponsible” in a press release—and ardently defended the safety and security of their devices.  The FDA acted immediately by beginning a joint investigation of the SJM device vulnerabilities in cooperation with the Department of Homeland Security. During the last year, SJM had been in the process of negotiating an acquisition deal with Abbott laboratories—the deal closed January 4, 2017.  Five days later, the FDA safety report was released.

Internet Connected Medical Devices Are At Risk: Guidance From The FDA

In December of 2016, (before the current SJM findings were released) the FDA published guidelines regarding cyber security issues and medical devices. As medicine becomes more digitally connected with patient devices being accessed via smartphones, tablets, doctor’s offices and hospital systems, security vulnerabilities are becoming more of a concern. In the document the FDA makes it clear that all medical devices are at risk and that more must be done in the pre market phase by industry to design more secure portals for data collection and device integration. I addition, more study is needed to identify potential risks and impact to patients. The guidance statement goes on to recommend a much more vigorous post market cyber security surveillance and suggests that all of the findings should be shared with the FDA. I expect that in the future, there will be a great deal more regulation involved for medical devices that are capable of wireless communication across the internet.

What Can We Learn from This? What’s Next?

Our lawmakers and the FDA must do more to regulate the medical device industry. We must do more to PUT PATIENTS FIRST. I am certain that SJM is not the only company with devices that are vulnerable to hacking—we have had reports of other devices—from MRI scanners, IV infusion pumps, personal insulin pumps and other connected devices that either have been compromised or have been identified as high risk. I think it is important for device makers to be proactive and tell us what we need to know now—What are they doing to do NOW to protect patients from cyber attacks? Outside research firms have suggested that most cyber security efforts related to medical devices and healthcare systems are lagging nearly a decade behind current technology. Many devices are still working on operating systems with known vulnerabilities such as Windows 7 and Windows XP.

I agree with the spirit of the FDA guidance statement from last month but I expect MORE. We must pursue post market cyber security issues aggressively. We must make every effort to identify and mitigate risk quickly. I would advocate for more cooperation between companies in cyber security efforts—by combining efforts to create more secure environments for medical devices and information, all parties will profit and ultimately patients and the healthcare system in general will benefit. . As a physician and a patient advocate, I am ready for change. While we must continue to promote free market competition and innovation, we MUST also protect the very people we are intending to serve—the patients who depend on us—and our devices—every single day.


New Law Could Speed FDA Approvals: Will Patients Still Be Safe?

This past week, the US House of Representatives passed legislation that has become known as the CURES ACT. This is thought to be the largest and most powerful healthcare related law since the passage of the Affordable Care Act during Obama’s first term. The Cures act provides for a large increase in funds for boosting biomedical research and also takes aim at speeding up drug and medical device approvals through the Federal Drug Administration (FDA). As expected, other items are also placed inside this bill such as funding for Opioid abuse as well as a program to better treat mental illness—making it very likely that President Obama will sign the law once it is approved by the Senate.

Many medical researchers have worried about what may happen to important and essential research funding for the National Institutes of Health (NIH) under a Trump administration and this law provides for more that 4 billion dollars for the NIH over the next decade.

How Might This Law Affect the FDA Process?

Currently drug and device makers must present data obtained from rigorous randomized controlled clinical trials (RCTs). RCTs provide the best type of evidence for the safety and efficacy of a drug or device and can Under the new law, companies would be able to use “surrogate endpoints” rather than hard outcomes to obtain approvals—this would make it far less expensive and time consuming for pharmaceutical and device companies to move new products through the FDA at a much quicker pace. Company controlled registry data would be accepted as evidence and RTCs would not always be required.

What Could This Mean for HealthCare Consumers?

Proponents of the legislation argue that this will be a huge step forward in public health. By providing such a large amount of funding for biomedical research as well as funding for work on opioid addiction and mental health treatments, that are likely to provide better treatment options for millions of Americans. In addition, simplifying the FDA approval process is likely to spur innovation—companies will be able to devote more time to research and development and patients will be able to reap the benefits of new therapies much faster. The FDA process is currently weighed down with lots of rules and regulations—providing a more clear path to approval may encourage smaller innovators and entrepreneurs to produce new products.

Opponents to the law argue that removing the requirement for robust data with hard endpoints to support the safety and efficacy of new drugs and devices may place patients at risk. Consumer and public safety groups worry that the law may open the door to the approval of unsafe drug and device approvals. Using observational data and patient feedback rather than RTCs may allow unsafe drugs and devices to enter the market; Companies may be incentivized to rush drugs and devices to the market with only anecdotal evidence in support of their efficacy or safety. Some experts argue that the law will de-legitimize the FDA and lead to patient harm.

The CURES Act—A Physician Perspective

As a practicing cardiologist, I rely on robust data to help me decide how best to treat my patients every single day. I trained at Duke University where we have the largest and most prolific center for the conduct of cardiovascular clinical trials in the world—the Duke Clinical Research Institute (DCRI). I was taught to only use a drug or device that had been rigorously evaluated by RCTs and that all other data was insufficient to determine safety and efficacy. Observational studies can provide correlation but not establish a true “cause and effect” relationship. However, it is often frustrating when we hear about a potentially practice-changing drug or device that is available in Europe but NOT available in the US due to a protracted FDA process. The FDA is currently not adequately funded to handle the amount of regulatory and administrative work they must accomplish in order to efficiently evaluate drugs and devices in a way that still protects patients from harm. The Cures act does provide more funding to the FDA but it is far short of what the agency really needs. I do think that they agency can still ensure patient safety by shifting the way they look a drugs and devices—more needs to be done in the area of pharmacovigilence or post market drug and device monitoring. Possible novel mechanisms for this monitoring could be “social listening” where artificial intelligence (AI) programs are used to sift through social media posts by patients in order to identify possible adverse drug or device events that may warrant investigation. Currently, the agency relies on self-reporting of these events—leading to under-reporting and duplication of reports—making the data relatively unreliable.

We must remember that the pharmaceutical and device industries are ‘for profit” and that they pursue FDA approvals in order to sell their products—as with most businesses, when they can cut expenses (such as in research and development costs) they will do so. This law will certainly allow for more innovation at a lower cost but I worry that this law will do little to change the cost of drugs (think Mylan and EpiPen). Unless there is some provision for more Pharmaceutical regulation I suspect that this law will have little effect on drug costs—it will help the bottom line of industry executives.

The provision of the Cure act that ensures funding of the NIH is incredibly important to researchers in health and science at academic institutions throughout the US. Much of the most important research that is conducted by medical schools and universities will be funded by the NIH and directed at finding cures for cancer and heart disease (just to name a few) through cutting edge genetic medicine. This funding is essential to advance science and develop new and exciting treatments for chronic disease—without it, many projects will never come to fruition and many bright minds may leave institutions that are focused on research in science and medicine.

Ultimately, I am pleased with the Cures act. I think that it is important legislation that will help bring treatments to patients faster—saving lives and improving quality of life. We must, however, continue to balance promoting innovation with patient safety. We must also ensure that, as we move forward, that attention is given to monitoring the practices of the drug and medical device industries—we cannot allow price gauging and we must ensure that all patients have fair and affordable access to the latest and most effective therapies.



Quit Beating A Dead Horse (and wasting money): The Day of the Pharma Rep is Done

As I sit behind a computer in my office today at the Physician’s “workstation”, I am baffled at the steady flow of Pharmaceutical representatives that flow into our office on a daily basis. Each rep comes in with a fancy glossy print detailing the data concerning their particular drug. My office is busy—patients are coming in and out and medical assistants are busy checking vitals and verifying medications (and of course, entering data into the computer system EMR). Yet the reps come in and stand at the workstation until someone acknowledges them. They stand, and stand—often distracting clinical staff. These reps are given a quota of “visits” they must make by their superiors. Many times they will arrive with their direct supervisor in tow—they are evaluated by the relationship they may (or may not have) with a group of physicians. But my time with each and every patient I see is limited due to the increased electronic medical record work that I must do—I feel bad for the reps (it is not their fault that they are placed in this role)—but Do I really have time to stop the endless flow of clinical work to speak to them? Does a Pharma rep actually provide any real value to me or to my patients? Would a “detail” presentation by any rep change my practice?

The Days of Yore

In the past, pharma reps were a source of “samples” that I could provide to my poorer patients who could not afford their meds. This was a real value—I depended on reps to provide these medications for my patients. In the days of print only access to journals, I may not have been as current with the medical literature. Reps would often come in and discuss breaking trial news that I had not yet had time to read about. Often they would discuss upcoming trials and plans for the future. We would have spirited “academic” debates over drugs, trial design and outcomes or endpoints. When you were unable to attend scientific meetings, the pharma rep would often be able to summarize the latest trials after they were released.

Now, my institution no longer allows “samples” to be left, and honestly, if I need a drug rep to share the latest data with me then I am not doing my job as a physician. Online access to immediate data from trials upon their release makes “keeping current” much easier. Social Media and other digital tools make it possible to attend national academic meetings such as the American Heart Association annual scientific session or the American College of Cardiology meetings allow everyone to be virtually present for ground breaking presentations of Late Breaking Clinical Trials.

Don’t get me wrong, there is nothing wrong with the people who choose to be pharma reps—many are smart, classy, well-meaning folks. However, there is a lot wrong with the antiquated pharma rep sales model in today’s world. Modern technology and easy access to data allows physicians to keep up with the latest clinical trials. Pharmaceutical detailing by reps is not very helpful—it is scripted and based solely on what the FDA allows them to say (think on label vs off label). Reps are not allowed to talk about upcoming trials or discuss any off label applications.

What’s the Answer?

Drug prices in the United States are far too high. Pharma will argue (rightfully so) that the costs of research and development (as well as marketing) drive those costs. However, I think that there are ways to lower costs without sacrificing R and D. I would argue that a restructuring of the pharma “sales force” would save significant dollars. I would also argue that making the FDA approval process more streamlined, faster and more agile would also lower costs. The current Congress is working on the “Cures Act” that will address some of the issues associated with the FDA process. Ultimately, I think that pharma must adjust to the way medicine is now practiced. There is no role for the pharmaceutical representative in the office or hospital. These individuals have absolutely no bearing on my choice to prescribe a particular drug and do not contribute to my continuing medical education. Nearly 75% of all Americans go to the internet after a doctor’s visit. Almost all physicians can access the internet immediately from a smartphone or tablet. Pharma should move their marketing and sales efforts to the digital space exclusively. There is no role for in person physician-pharma rep interaction in medicine today. Use these dollars in better ways—fund patient assistance programs, improve treatments and fund clinical trials. Stop spending money on lunches for the office staff and on fancy packaging. Glossy detail cards are simply tossed in the trash as soon as the representative leaves the building. Focus more on patients. The days of the drug rep have come to an end.


A Battle is Brewing—Changing Medicare and The Impact on the US Healthcare System

For years, Paul Ryan and other Republican leaders have been touting a change to Medicare in order to safe money and increase benefits to Americans. Democrats have rigidly opposed ANY modifications to the Medicare system.

Republicans now support the idea of “premium support”. In this model, Medicare beneficiaries would purchase insurance from a group of selected plans. These plans would compete directly with traditional insurers such as Humana, United, BCBC and others. The government would contribute the same basic amount to all beneficiaries. If a individual selects a more expensive plan or a plan with a lower deductible, they would pay the difference between the premium they choose and the amount that Medicare provides. If a beneficiary chooses a less expensive option, they would receive a rebate or extra benefits from the government.

What Would This Mean for Medicare?

Competition and free market forces are likely to lower prices overall and improve the services that insurers provide—many private insurers will be competing to insure Medicare beneficiaries. Due to the sheer volume of customers, many private insurers would likely offer cheaper options and work to cash in on a “by volume” business. By providing vouchers for Medicare, Republicans argue that they are providing more choice. Currently, many physicians will not accept Medicare patients due to very poor rates of reimbursement and complex filing requirements. In addition, Medicare can refuse to pay claims for months at a time if they decide to make a rate change or computer system upgrade, for example. I believe that if there is competition among insurers, more physicians may be likely to accept Medicare patients. More physician choices will improve access to care for older Americans. In many geographies across the US, patients now have very limited choice.

What Are Democrats Saying?

Democrats are adamantly opposed to these changes. They argue that by effectively “privatizing” Medicare that individual costs for beneficiaries will rise. They worry that those with multiple chronic medical conditions will be given a fixed amount of healthcare money to work with that they will incur significant “overage” expenses. IN addition, those opposed to the “privatization” model also argue that those who are more affluent and those that have fewer medical problems will be more likely to purchase a private insurance plan with a voucher—leaving those who remain in traditional Medicare plans older, sicker and more expensive. Medicare has long been a traditional Democratic Party campaign issue—often using fear of loss of benefits as a way to sway older voters.

What’s Next?

Nearly one third of the 57 million Americans on Medicare are already on private Medicare Advantage plans. However, current Federal law limits the competition among more traditional insurers and there is no bidding against private plans. In the next Congress, I expect we will see more debate on this issue. At the current rate of spending and under its current structure, Medicare is not going to be a viable way to care for Americans. We must do something to modify the plan and provide CHOICE, ACCESS and HIGH QUALITY care to all Medicare eligible Americans. The current system provides physicians with very poor reimbursement and ultimately, many doctors will no longer be able to care for Medicare patients—simply from an economic viability standpoint.



What Does a Trump Presidency Mean For Healthcare?

While much about a Trump Presidency remains relatively unclear, one thing is for certain—the way healthcare is handled in the US today will change.

One of Mr Trump’s biggest issues while on the campaign trail was his promise to “Repeal and Replace” Obamacare.


–Based on his most recent comments on 60 Minutes, it appears that Mr. Trump will keep a very important provision that ensures that those with pre existing conditions will remain insured. If we do not keep this provision, we will go back to the days when insurers could discriminate against individuals with chronic medical problems by either denying coverage or making coverage far too expensive. It is essential that this stay in place in order to make sure that ALL Americans are covered (in an affordable way)—regardless of what chronic medical problems they may have.

–Mr. Trump has also indicated that he will keep the provision that allows young adults to stay on their parent’s plans thru age 26. I think this too is vital. Young adults are building careers and often are scraping to get by from a financial standpoint while they complete higher education and low paying internship training programs. I think allowing these individuals to stay on their parent’s plans only makes sense. It alleviates a significant financial burden during the time in which they are developing careers and working towards education goals in order to make significant contributions to society.

This is where the water gets a little “murky”. Trump says that he will “Repeal and Replace” Obamacare—this may be difficult from a legislative standpoint unless the Republicans invoke the Harry Reid approach of the “nuclear option” in Congress. Currently it will take 61 votes in the Senate in order to repeal the legislation. Based on the partisan politics we are likely to see in Congress, this is unlikely to happen. Alternatively, Trump can “starve the ACA” by signing a bill similar to the one that was sent to Obama a few years ago that essentially defunded the ACA. (Obama of course vetoed that bill).

Over the last year, President Obama has been using Treasury monies that were meant for tax refunds to pay back insurers in the exchanges that have had high cost patients. While the ACA provided for these payments, Congress did not fund this provision so Obama has been re-appropriating money from other sources. There is a court case pending that is likely to stop this action. However, Trump can stop it immediately on Jan 20th. If this happens, I worry that more insurers are likely to pull out of the exchanges and the ACA will continue to slowly implode.


While it is likely that any plan will involve the Republican/Ryan proposal that has been crafted for more than a year, Mr Trump has discussed a few specifics during the course of the campaign. It is unclear at this point just how much of this will be implemented.

  1. Allow insurers to sell insurance across state lines

–By allowing free market competition, Trump argues that competition for patients by insurance companies will lead to better service, lower prices and more patient satisfaction

  1. Allow individuals to deduct healthcare premiums from taxes

–By putting more $ in individual pockets, patients will be better able to afford healthcare

  1. Allow individuals to set up Healthcare savings accounts (HSAs) tax free money

—tax free accumulation for healthcare spending

  1. The individual and employer mandates will be eliminated 

—Allow individuals to CHOOSE if they wish to purchase health insurance

5.  Price transparency for doctors and hospitals

–Prices for common surgeries and services vary widely by geography and hospital. By requiring transparency, patients can shop around, using both quality and price data to determine the best place for them

–This will prevent gouging by certain hospital systems.

  1. Begin a Block grant to states to deal with Medicaid

— The federal government would send money to the states. It would then be up to the states as to how to use the money to cover the citizens.   This may not be good as in some states it is likely to lead to decrease payments to docs and hospitals and may leave more low income Americans without adequate care

  1. Streamline the FDA and allow Americans to purchase prescription drugs from other countries.

–Currently the US pays far too much for drugs that can be obtained in Canada and elsewhere for much less. Why should the US pay all of the R and D costs for the world?

  1. Privatize Medicare—Other Medicare changes

–Provide citizens with a choice—use medicare dollars to see a medicare doctor or use that money to pay for private doctor that does not take medicare. May result in more out of pocket expenses for seniors.

–Allow medicare to negotiate drug prices—lower costs to Federally sponsored healthcare plans

Ultimately we must put a healthcare plan in place that will cover all Americans and we must make sure that the plan allows for low costs and easy access. However, I do not think this will be a “quick fix”. If there is no good replacement plan I am concerned that there may be 25million new uninsured Americans. However, many of these while listed as insured, are currently functionally uninsured due to limited access, high copays and premiums and deductibles. It is my hope that Congress will work quickly to craft a fiscally responsible healthcare plan that works for ALL Americans—and allows doctors to be healers once again.







‘The Rest of the Story’—SJM Leadership Explains the ICD Battery Advisory

After writing my opinion piece for Bold.Global two weeks ago, I have received many comments and I felt it necessary to produce a follow up article. Much of the buzz surrounding the advisory has had a lot to do with the timeline of events—what happened when and how the company responded to concerns over the current ICD battery issues. I obtained a copy of the SEC filing that is required during an acquisition such the Abbott Laboratories/SJM deal. I also reached out to the leadership at SJM. After speaking with St Jude Medial Chief Medical Officer Mark Carlson last week and reviewing the SEC filing, I wanted to provide a bit more information and share what I have learned. Dr Carlson agreed to allow me to quote him in the production of this piece.

The AdvisoryTimeline (as provided by Dr. Carlson from SJM):

–2010 SJM begins production of the FDA approved family of devices that are the subject of the current advisory

–Following an ongoing internal investigation of lithium deposits at SJM, by 2014, there were a small number of devices that were found to have a lithium deposit induced short associated with premature battery depletion

–The first report of a patient death associated with premature battery depletion was in June of 2014.  According to Dr Carlson, returned product analysis found no evidence of lithium cluster induced shorting

–November 11, 2014 SJM convened their Medical Advisory Board to discuss the premature battery depletion cases. SJM reported that the rate of battery depletion due to shorts was 0.004% of worldwide sales. MAB recommended continued monitoring rather than market withdrawal

–May 2015 SJM worked with battery manufacturer to produce a “design enhancement” in order to avoid further lithium deposit related shorts.

–August 25, 2016 SJM MAB reconvened to discuss the battery issue. Based on the recommendations from the MAB, SJM began the process of communicating an advisory with the FDA

–The second report of a patient death associated with premature battery depletion on March of 2016. The product analysis found no evidence of lithium cluster induced shorting.

–October 11, 2016 SJM issues an advisory due to the premature failure of batteries related to lithium deposits. At the time of the advisory there were 2 reported deaths, 46 confirmed shorts and 795 unconfirmed shorts (.21% of total sales).


The Acquisition Timeline (taken from the SEC filing on public record)

–On December 15, 2015, members of the respective managements of Abbott and St. Jude Medical met and that meeting also served as an introductory meeting between Miles D. White, chief executive officer of Abbott, and Michael T. Rousseau, the incoming chief executive officer of St. Jude Medical. During the course of the meeting Mr. White indicated to Mr. Rousseau an interest in discussing a potential business combination between Abbott and St. Jude Medical.

–During the first week of January 2016, Mr. White contacted Daniel J. Starks, former chief executive officer and current executive chairman of St. Jude Medical, regarding a possible business combination between Abbott and St. Jude Medical.

They agreed to meet in person later in the month.

–On January 23, 2016, White and Starks met in person and at this meeting, Mr. White indicated that Abbott expected to present St. Jude Medical with a proposal to acquire St. Jude Medical.

–On February 23, 2016, Mr. White called Mr. Starks to communicate a preliminary indication of interest for Abbott to acquire St. Jude Medical at an indicative value of $83.00 per St. Jude Medical share, with consideration consisting of 60% in cash and 40% in Abbott shares, subject to due diligence. On that date, the closing price of St. Jude Medical shares was approximately $53.99 per share.

–On February 29, 2016, members of management of Abbott and St. Jude Medical met. St. Jude Medical management delivered a presentation on the company’s businesses, financial information and operations. Abbott began a due diligence review of SJM

–On March 13, 2016, Abbott communicated an updated proposal for the acquisition of St. Jude Medical at an indicative value of $84.00 per St. Jude Medical share, with consideration consisting of 60% in cash and 40% in Abbott shares.

–On March 15, 2016, the St. Jude made a counterproposal for Abbott to acquire St. Jude Medical at value of $85.00 per St. Jude Medical share, based on a mix of cash and stock consideration. On March 16, 2016, the closing price of St. Jude Medical shares was approximately $54.50 per share.

–After agreeing to terms as outlined above, Abbott and St. Jude Medical executed the merger agreement after the closing of trading on the NYSE on April 27, 2016. Abbott and St. Jude Medical announced the transaction with a joint press release prior to the opening of trading on the NYSE on April 28, 2016.


Putting all of this In Perspective: Where Does this Leave Us?

It is clear that the timelines (as reported by SJM) that led up to the issuance of the battery advisory did overlap with the acquisition talks with Abbott during late 2015 and all of 2016. However, based on SEC filings, it appears that the initial investigation of the battery issues preceded the discussions with Abbott by more than a year. During this time, the SJM stock price fluctuated by nearly 20 points according to SEC documents. So, exactly how much did the acquisition proceedings influence the timing of the advisory for the current battery issue? We may never truly know—it is my hope that those who lead in the medical device industry will consider the enormous impact that their decisions have on patients—Both GOOD and BAD. I sincerely hope that senior leadership recognizes that the choices they make every day affects real human beings. In the interest of full disclosure, I must admit that I know many of these individuals at SJM personally and call many of them friends– and I have always had great respect for each of them. However, I have had no direct knowledge or involvement in the business dealings of SJM. I also have had no knowledge of any battery issues with SJM devices until the day before the advisory was released to the press in early October 2016. During the timeline of SJM internal investigations of the battery issues, I and all other physicians continued to implant these devices without any knowledge that there was a possible concern—only SJM and their medical advisory board were aware.

Based on the information provided to me by Dr. Mark Carlson, it does appear that SJM did have discussions with the Key Opinion Leaders (KOLs) on their Medical Advisory Board early on in the process. It also appears that SJM did pursue due diligence in the analysis of the behavior of lithium deposits in medical devices. From my research into the lithium issue it does appear that others in the market—including Medtronic as well as Boston Scientific—have also noted issues with deposits that may affect battery life. These reports indicate that these occurrences are quite low. However, many patients depend on these devices to have a ZERO failure rate (and yes, I realize this is not possible). In addition, I have learned that the lithium deposits have been found to be “fluid”—they may appear and disappear over time. After reviewing the available information, it does appear that the St. Jude Medical team did work in a systematic way to determine the root cause of premature battery depletion with a goal of balancing patient safety with business success. It does appear that the company did continue to sell the devices in question after the battery manufacturing process was altered and according to Dr Carlson this was due to the fact that (after discussions with the medical advisory board) the failure rate was very low and did not meet criteria to take action either internally or with the FDA .

Ultimately, more needs to be done in the Medical device AND pharmaceutical industries in order to protect patients. While under a certainly a completely different set of circumstances, recent well-publicized pharma company actions (such as Mylan and Epi Pen rate hikes) have reflected poorly upon the entire medical device and drug industry. Unfortunately, these activities have served to increase suspicion concerning the motives of industry leaders. As healthcare consumers, we must work to hold all in the industry accountable—However, we must also approach each situation with an open mind and evaluate each case individually. Time will tell just how significant the current SJM advisory truly is and if other companies have similar issues.  It is my hope that industry leaders will advocate not only for stockholders but for patients as well.


Getting Successful with Social: Tips to Build a Digital Following

Social Media and the digital space is ubiquitous in today’s society. As consumers of media, we are constantly flooded with data—how can we best handle the influx of information, process it and engage others? Here are some of my TIPS for building a powerful digital following!

Social Media use among millennials is widespread and continues to grow. Believe it or not, the older Gen X-er’s and Baby Boomers are also jumping on board—IN fact the fastest growing demographic on twitter is the 55-65 year old set.

The widespread use of social media across generations provides us all with an enormous opportunity to engage with others and make a significant impact.

As a media personality and a physician, I use social media and the digital space in many different capacities—

–To Teach

–To Market

–To Brand

–To Engage

–To Collaborate

–To Become a KOL (Key Opinion Leader)

I believe that all digital users—regardless of background, goals and target audience should also be focusing on each of these areas.

Here are some key tips for success:

  1. KNOW your audience. Find out what they want and who they are. Understand what is important the THEM—remember it is “all about them, not all about YOU”
  2. Provide relevant, timely content. Consistently update your profile and always respond to inquiries and current events
  3. Engage in conversation with other Key Opinion Leaders (KOL’s) –follow them and respond to their content
  4. Create a buzz—Give your audience a reason to consistently come back to your social platforms and ultimately broaden your reach.

And don’t forget to Use technology to target your audience. My friends at MDDigital Life have developed amazing software that can actually “map” your digital reach. By examining the way in which you are connected you can better reach out to those you want to influence and engage. Just as in medicine, data provides you with the ability to develop a successful strategy. Here is my Twitter reach below.


Check out to see how this map was created and how you can better engage your connections today!