Category Archives: personalized medicine

Regulators Take Aim at Genomics

Here’s the first part of my column on the recent Congressional investigation into the genomcs industry:

The genomics industry, which provides reports about disease risk, ancestry, and drug reactions based on one’s DNA, came under fire last week as a Congressional Committee held hearings and the Government Accountability Office (GAO) released an unscientific “study” of the sector.

According to undercover discussions with genomics firms, the GAO reports that “fictitious consumers received test results that are misleading and of little or no practical use.” The agency admits, however, that it “did not conduct a scientific study but instead documented observations that could be made by any consumer.”

The GAO’s “sting” operation on this nascent field looks more like a witch hunt, given that it lumped in legitimate testing companies with others that are not.

In one instance, a company representative said that it would be OK to send in someone else’s saliva to be tested. As the GAO points out, that practice is already restricted in 33 states, so this seems more like a matter of enforcement.

The GAO’s report is a tricky way of attempting to perturb the public about genetic testing, but it also raises a key question: Why haven’t government regulators disciplined the companies that are clearly breaking the already-established rules?

The GAO also blasts the genomics industry for providing different results for the same DNA, but when dealing with something as complicated as the human body, there often are valid scientific reasons for variation. As 23andMe points out on its blog, testing is not yet standardized, and some companies “employ different statistical models for making risk estimates; they establish different criteria for the inclusion of associations in their reports; and new associations are being discovered at a faster rate than companies’ development cycles.”


Read more here:

Genomics industry facing risk of government regulation

It’s been a tough week for the personal genomics testing marketplace. First there were two long days of FDA meetings, and then today an Energy and Commerce Committee held hearings where the GAO announced the results of a “sting” operation into direct to consumer (DTC) genomics companies. Below is the (brutal) GAO video. As Daniel MacArthur has pointed out, today there exist both legitimate and not-so-legitimate testing firms, but the GAO has lumped them all in together, which will make it easier for pro-regulatory forces to get their hooks into the industry. I urge you to read MacArthur’s entire analysis here, since he follows the industry closely and is saddened by the fact that:

The momentum seems to be well and truly in favour of the bureaucrats now. The prospect of increased regulation (specifically from the FDA) seemed to be enthusiastically received by the Committee today; there was explicit mention of increased money for the FDA to support such a move. The shape of this regulation is as yet unclear, but I’m now extremely pessimistic about the industry’s prospects of escaping excessive, innovation-crushing regulation in the US.

This is very bad news for those of us who wish to see personal medicine flourish.

IBM looking to win the x-prize in genomics?

A press release today says that “IBM Research Aims to Build Nanoscale DNA Sequencer to Help Drive Down Cost of Personalized Genetic Analysis”. The release goes on to say that “This advanced research effort to demonstrate a silicon-based “DNA Transistor” could help pave the way to read human DNA easily and quickly, generating advancements in health condition diagnosis and treatment. The challenge in the effort is to slow and control the motion of the DNA through the hole so the reader can accurately decode what is in the DNA. If successful, the project could improve throughput and reduce cost to achieve the vision of personalized genome analysis at a cost of $100 to $1,000.”

In order to win the X-prize in genomics, a team must
“build a device and use it to sequence 100 human genomes within 10 days or less, with an accuracy of no more than one error in every 100,000 bases sequenced, with sequences accurately covering at least 98% of the genome, and at a recurring cost of no more than $10,000 per genome.”

Is the FDA trying to kill adult stem cell medicine?

Here’s an informative article from h+ magazine on how the FDA currently argues that culturing adult stem cells amounts to the creation of a new drug. This of course would mean long time lags for getting stem cell procedures approved, which has prompted the creation of at least two groups: the American Stem Cell Therapy Association (ASCTA) and Safe Stem Cells NOW! (both focused on adult stem cells).

It doesn’t make sense to me that my own cells would be considered a “drug,” but Dr. Christopher J. Centeno who was interviewed for this article by Stephen Coles says that “The FDA is working to protect the interests of Big Pharma.” Yikes — if that’s the case, it’s a huge setback for personalized medicine.

Precision medicine vs personalized medicine

This is an interesting piece in the Economist about the upcoming personalized medicine revolution. Some people are skeptical that medicine really will be personalized, so Clayton Christensen of Harvard Business School has come up with a term that means “customization”, perhaps sort of like how Dell or other retail outlets might customize products. He calls it “precision medicine”.

Of course, there are also incredibly forward-looking people working directly in the industry that see how much promise and information power is available. For instance, George Church (also at Harvard), who worked on the original Human Genome Project and now advises several genomics firms, argues that at some point “genome sequencing “will in effect be available free” because companies will give away sequencing to sell other services, such as genetic interpretation—much as mobile operators “give away” handsets to get customers to sign up for lucrative service plans. And when this happens, he reckons, “it will be just like the internet: once all this information is floating around, a lot of creative people with PCs will nose around and develop applications.”

I can’t wait.

Personalized medicine and cancer drugs

The WSJ today reported that “New genetic research emerging from a major cancer meeting [annual meeting of the American Society of Clinical Oncology] could help doctors better identify the drugs most likely to work in their patients — but sharply reduce the market for certain blockbuster cancer drugs.”

Interesting that they are predicting more drug products for smaller markets. Apparently, “Both Amgen and Merck argue that patients who are successfully treated will stay on the drugs longer, potentially offsetting at least some of the impact of narrowing the target market.”