Idea #315 for December 30th, 2009: Passing Muster or Stricter Device Approval Guidelines At The FDA

The FDA has announced plans to implement a more strict process for the approval of medical devices. This decision comes after several journal articles brought to light flaws in the current approval process. For instance, an article in JAMA showed that the approvals of a number of cardiovascular devices in the last decade were based on a single study. Also, only about half of the outcomes in the studies were compared to control groups. Rigor has certainly been lacking in these FDA approvals. It might be a case of too little, too late, but at least the FDA has admitted to the problem and will make an effort to address it.

Read more about this story here.

Idea #105 for June 3rd, 2009: Lifting the Veil of Secrecy or Transparency at the FDA

Some more promising news out of the FDA: they’ve created a task force that will look out how the agency can increase their transparency. As it stands now, details on the FDA’s decision making process for drug and device approval may be hidden under a shroud of “trade secrecy.” The danger is, without disclosing clinical trial details, some drugs may be perceived as more effective than they are in reality, and complete information about their safety may not be available to the public.

The New York Times cites three examples where that secrecy has prevented the FDA from releasing valuable information to the public: a popular heartburn drug was known to be toxic to babies, a diabetes drug and a pain-killer increased the risk of heart attack, and antidepressants were linked to increased suicides in teens. In each case, a more transparency could have saved lives. It seems like the FDA is opting to protect manufacturers’ trade secrets over ensuring Americans’ health.

For transparency to come about, existing laws will need to be rewritten and multiple Congressional committees will have to be involved. But this is too important a reform to be ignored or abandoned. The FDA for too long has sided with the interests of industry over the interests of the public. This could be the start of a promising shift in the FDA’s priorities concerning industry trade secrets.

In the media, see this editorial in the NY Times, this story in Forbes and this story in USA Today

Idea #17 for March 7th, 2009: DIY ECG or the Cost of Medical Devices

If a hobbyist can build a prototype ECG in a garage for just $5, but major manufacturers like HP or Welch-Allyn sell professional ECGs for $1,500-$12,000, then something is wrong with medical device pricing. I am definitely not saying that, should I end up in the ER, I want to see my neighbor’s 15-year-old son hacking together my ECG with a bread board and soldering iron. But what is reasonable?

Real-time monitoring devices that are invaluable for many patients at high risk are astronomically expensive when they should be cheap and ubiquitous. If Amazon can make the Kindle for $300, then someone can certainly make a real-time vitals monitoring device that can go anywhere for less…am I wrong? Certainly there are many legitimate expenses regarding certification, testing, compliance with FDA standards and approval etc., but ECGs (in some form) have been around since 1872. Why haven’t the costs come down more over time? Is the answer lack of competition?

Medical devices are a regulated market under the FDA, but there are no cost controls. Critics of cost controls point out that they deter investment in promising technology, stifling innovation. This might be true, but the way the medical device market works now is comparable to a de facto monopoly, in some cases. For highly specialized and expensive equipment, very few companies actually produce the devices, allowing them to charge exorbitant prices in their competition-free environment. There has to be a way to control costs and at the same time foster innovation.

If the process was approached like generic drug approval, costs could be reduced significantly. As detailed in a previous post, the approval of generic drugs does not require the full-scale testing requirements of initial drug approval. Rather, the manufacturer has to show the drug is chemically and biological equivalent to the previously approved version. An analogous process could be used in medical device approval. If manufacturers could use existing approved designs, the approval process would be much simpler. Of course, the patent system would need to be changed for this to work, but that change would be less harmful to innovation than imposing cost control measures.

Read about the $5 ECG here and this site promoting an Open Source ECG. Also, check out this page to learn more about over-priced medical devices.