Category: Devices

How crazy is Ted Cruz's FDA reform proposal?

published date
January 4th, 2016 by


I don’t think very highly of Senator and Republican Presidential candidate Ted Cruz, but his proposal to loosen the drug approval process is at least worth discussing. If you haven’t heard, Cruz’s RESULT Act proposal is as follows:

  • FDA to grant reciprocal approval of “life-saving” drugs and devices from regulatory agencies in developed countries including EU, Israel, Australia, Canada and Japan. FDA would have only 30 days to review and approve
  • Congress can override FDA decisions with a majority vote

Basically he is trying to make it easier to get drugs and devices on the market. There are a number of problems with this approach, which are pointed out by my most of the respectable analysts. Objections include:

  • FDA may just reject the applications anyway since 30 days is not a long enough time to review and they may object to procedures used elsewhere
  • Insertinbg Congress directly into the process undermines the scientific basis of the decision
  • Trial sponsors may seek the jurisdiction with the lowest standards or fastest review times, imperiling safety for Americans
  • It would hurt US economic development by shifting development resources overseas
  • We would be ceding our sovereignty to foreigners
  • FDA is already pretty fast and responsive and has programs for compassionate use and acceleration of the approval process when warranted

These are all reasonable, and yet I was struck by the fact that almost all the commentators use  the Thalidomide debacle as their one and only example.  See for example STAT, The FDA Group Blog, and Harvard Law Blog, which are the top articles that come up under a Google search for “Ted Cruz FDA proposal.”

Thalidomide was approved in Europe as a sleeping pill and for morning sickness but rejected in the US. It caused serious birth defects, with thousands of people affected in Europe but not the US. Great example but we’re talking 1956. Remember 1956? I don’t. But to give you some perspective it was just two years after food rationing was lifted in the UK and nine years before Medicare was established. Soviet troops rolled into Hungary to crush the uprising there.

I don’t hear people citing 1956 examples about anything else in healthcare.

A more serious discussion could be held on the balance between safety and efficacy in FDA approvals. Cruz’s impulses might be better directed to that debate. Maybe it’s ok for FDA to approve any product that’s safe, and not force sponsors to prove efficacy. Sponsors would still want to demonstrate efficacy, but they’d need to do so for healthcare payers, not the FDA.

That’s not as simple as it sounds either. Here are some of the challenges:

  • The biggest payers are Medicare and Medicaid, so even if you take FDA out of the business of judging efficacy the government is still involved
  • In many situations, safety is relative, not absolute. I might accept a modestly effective cancer drug that kills 1 percent of those who take it, while I wouldn’t accept a cure for toenail fungus with the same death rate. But it’s also important to protect cancer patients from dangerous drugs. A recent NYT article about the death from cancer of the wife of the FDA’s head of oncology included this important and under-appreciated point: “Cancer medicines not only often fail to save patients but can accelerate their deaths and make their last weeks far more painful”
  • Safety and efficacy are individualized. (Cruz seems to recognize this.) Some drugs will be effective for only a small population; similarly safety issues don’t always apply across the board. I would want access to a drug that could cure me even if it could kill someone else, especially if there were a companion diagnostic to sort out who will be helped and hurt

Overall I think the FDA is doing a good job of managing the conflicting pressures it faces. Some parts of FDA (such as the groups with responsibility for HIV and oncology) do a better job than others.

I really would like to see Cruz’s proposal spur a more productive debate and not simply be dismissed out of hand.

Image courtesy of vectorolie at

By healthcare business consultant David E. Williams, president of Health Business Group.

Clerio Vision takes a step past LASIK (podcast)

published date
November 2nd, 2015 by
Clerio Visio CEO, Mikael Totterman
Clerio Visio CEO, Mikael Totterman

Clerio Vision is developing a non-invasive, tissue-sparing laser technology that corrects vision by modifying the reactive index of the cornea. It’s the third med-tech spinout from the University of Rochester for CEO Mikael Totterman and is starting to get some press, including this BioTuesdays piece. I’m on the company’s board of directors.

I caught up with Mikael recently to discuss the company’s progress.

  • (0:20) Clerio is developing a laser technology for refractive eye surgery. We already have LASIK. Do we need another approach?
  • (2:44) So LASIK has downsides, but you also use lasers. What’s the difference?
  • (3:35) How do you test something like this? What testing has been done?
  • (4:51) If the technology is so promising, why did Bausch & Lomb stop development?
  • (6:30) What steps have you taken with the company since its founding?
  • (7:55) When can we expect to see a product on the market?
  • (8:56) This is at least the third company you’ve spun out of U of R. What is the biggest lesson that you learned and how are you applying these insights to Clerio?
  • (11:00) What sort of development costs are required for commercialization? How are you funded?
  • (12:08) What else should I know?
  • (13:25) When you make modifications to intraocular lenses for cataracts, do you do it before or after implantation?

By healthcare business consultant David E. Williams, president of Health Business Group.



Emotion tracking tools –only for trivial purposes?

published date
September 22nd, 2015 by
Who am i?
Who am i?

I was surprised that the Boston Globe’s (Waltham firm helps computers learn empathy by mapping the human face) highlighted such unimportant opportunities for the technology. Here’s what MIT Media Lab spinoff Affectiva is doing, according to the Globe:

  • Helping companies measure emotional responses to advertising
  • Spitting out pieces of chocolate for Hershey’s when someone smiles at the machine

Maybe that’s not so bad for initial applications, but what’s down the road sounds pretty unimportant as well

“If a student got stuck on a tough math problem, an empathetic school computer would recognize the confused look on his face, and instantly offer additional help. An office laptop might see that a worker is bored, and suggest that he take a coffee break or play a simple computer game. A TV that notices that nobody laughed at last night’s Adam Sandler movie might suggest Woody Allen next time.”

Give me a break. A much more profound application for these tools will be to give people better insights into others’ emotions in live one-on-one and group interactions. It will be especially helpful for people with autism and Asperger’s, but it will also be useful for the average person to better understand how others react to them. The technology could (and I assume will) be built in to a next generation of Google Glass or similar.

I know some people who could use such a tool.

I’m not suggesting anything that hasn’t already been thought of, but the Globe should have done a better job reporting on this.

Image courtesy of David Castillo Dominici at

By healthcare business consultant David E. Williams, president of Health Business Group.

An inspiring product development tale

published date
July 17th, 2015 by
Just do it
Just do it

The times they are a changing, and in some ways for the better. Nike is releasing a new sneaker designed for people with disabilities who have trouble putting regular shoes on by themselves. The idea for the shoe came from a teen with cerebral palsy who wrote a letter to Nike that ended up with the CEO. A related request came from a Nike employee who had suffered a stroke.

The company then spent three years to design a sneaker with what USA Today calls “an elongated wraparound zipper system to allow a wearer to open close the show with one hand.” They collaborated with the teen to perfect the design.

This isn’t some clunky looking, medicalized shoe. Instead, the Zoom Soldier 8 Flyease is a variation on a Lebron James basketball shoe. It’s cool and stylish.

Advocates for the disabled are pleased, because Nike can make a significant impact on quality of life with this product, and because it represents a new phase of acceptance for people who are a little different. I won’t be surprised if the shoe is a big hit –there are lots of people who have physical challenges of various types who might really like it.

If Nike can make money on the concept, that’s good news for everyone because it will demonstrate that this is a profitable opportunity, which will encourage others to compete.

The situation reminds me somewhat of the highway safety movement a generation ago. Although the problem of avoidable automobile deaths was there if you looked for it, the auto industry –with the exception of Volvo– wanted nothing to do with it. But once the public started to express an interest in safety, the world changed, and car companies started to compete on safety as well as styling and power.

Image courtesy of David Castillo Dominici at

By healthcare business consultant David E. Williams, president of Health Business Group.

Apple Watch: Continuous glucose monitoring

published date
May 13th, 2015 by
Watch this!
Watch this!

Looking for something useful to do with your Apple Watch? Dexcom, the maker of a continuous glucose monitor (CGM) for diabetics, suggests you use the watch to monitor CGM –your own or someone else’s. This functionality has been available as a smartphone app, but the watch version is designed to be more convenient and discreet.

Dexcom answered my questions below:

  1. Is the Apple Watch useful or more of a toy or gimmick?

For people with diabetes, their family members and loved ones, the Apple Watch is an extremely useful tool. It lets people access their blood glucose data right from their wrist, providing superior convenience and discretion.

  1. What opportunities does the watch provide for people with diabetes? What is the incremental improvement from a smartphone?

The Apple Watch allows greater convenience for those who want this important information in an easy-to-use and discreet form. We share Apple’s commitment to making technology more accessible, relevant and personal.

  1. How does the Dexcom CGM work on the Apple Watch? What are patients really getting?

Dexcom CGM provides patients the opportunity to track their glucose levels and trends right on their wrist with the Apple Watch. Here’s how it works: The user downloads either of the Dexcom apps, Share2 or Follow to their iPhone. The Dexcom G4 PLATINUM System with Share transmits that user’s glucose information to the Share receiver using BLE (Bluetooth Low Energy) wireless communication technology. The Share receiver then sends the information through the iPhone to the watch. The Dexcom apps on the iPhone sync with the watch to provide caregivers and people with diabetes continuously updated glucose information and trend graphs. Additionally, patients or “Sharers” can invite up to five people to view their glucose information and send an alert when the sharer’s glucose levels are outside the norm.

  1. What are the benefits to allowing other users to “follow” your glucose levels on their own devices?

The Dexcom apps will now enable users to monitor glucose on the Apple Watch so that people with diabetes can discreetly view their own information while parents and caregivers can conveniently view a child or loved one’s glucose data, giving them peace of mind and reassurance when they are apart. Examples of people who may benefit include a parent who can monitor a child’s blood glucose levels at night, while the child is at a sleepover, or away at camp or college. Or, a spouse can monitor their loved one’s glucose while they are away on a business trip. It’s useful for anyone who wants to monitor or share glucose information from a remote location.

  1. What information can a person with diabetes or caregiver get when they log into the apps?

Through the Dexcom apps, Share2 and Follow, caregivers and people with diabetes have access to glucose data in real time. They allow both users and “followers” to view glucose data directly on their phone and now on the watch.

  1. Does the Watch set off alarms for patients and followers?

Yes, with an iPhone and the Follow app installed, the watch can alert the Sharer and follower when the Sharer’s glucose levels are outside the designated range, allowing appropriate action to be taken.

  1. Can patients just use the watch and no longer wear the receiver?

Patients will need to have the Dexcom receiver in order for the glucose data to be sent to the iPhone and the watch. For the Apple Watch to work for this purpose, the receiver and the phone are both needed.

  1. What is the benefit of CGM in relation to other methods for monitoring and managing diabetes?

For someone with diabetes, monitoring blood glucose, or blood sugar, levels is a very important part of managing their diabetes. The traditional method for monitoring blood sugar levels is with a blood glucose meter where only a point in time reading is viewed a few times per day. But CGM is a dynamic tool that provides continuous glucose readings (up to 288 readings per day) along with the speed and direction that the glucose levels are headed. In addition, CGM has alerts to let the user know when they are heading too high or low so that action can be taken prior to it reaching a level of concern. Continuous glucose monitoring, or CGM, is considered the most significant breakthrough in diabetes management in the past 40 years.CGM augments the use of glucose meters for the management of diabetes. Meters are still required to calibrate CGMs and for guidance in making therapy and meal decisions.

  1. How do patients with diabetes go about getting the diabetes app? Is it included with the watch, is there an additional cost?

The Share2 and Follow apps can be downloaded for free through the App Store.

  1. Is CGM for Type 1, Type 2 or both?

A Continuous glucose monitor, or CGM, can be used by any person with type 1 or type 2 diabetes on insulin who is concerned about his or her diabetes management. People with diabetes who take insulin must monitor their blood glucose levels frequently. Uncontrolled glucose can cause health complications and can even be life-threatening.

  1. There have been concerns about the Apple Watch battery life. Is there any impact on CGM?

The Dexcom receiver houses all the CGM capabilities. In order to get CGM functionality on the Apple Watch, patients must have their receiver with them at all times.

By healthcare business consultant David E. Williams, president of Health Business Group.