Tuesday, December 16, 2008

Is Genentech attempting to stifle competition in personalized medicine?

Genentech (DNA) recently filed a Citizen Petition with the FDA attempting to persuade the agency to use a monocle for ALL diagnostic tests, with particular attention paid to Laboratory Developed Tests which are designed to guide therapeutic decisions.

"According to Genentech, pharmacogenomic information is contained on the label of around 10 percent of all FDA-approved drugs." -- Genomeweb

This is a surprisingly high number if it's true but even if it is not the percentage is sure to grow as we learn more about human genetic variation.

Interestingly, DNA received nearly instantaneous support from Kathy Hudson at the Center for Genetics and Public Policy. She is clearly developing an integral position as an informed player in this and other ongoing debates. However, as a policy group, it seemed odd to provide such quick, unconditional and one-sided support to a single, large, publicly-traded company without a counterbalancing perspective on behalf of all the small and mid-sized laboratories doing innovative work in this nascent field. Particularly because a fair amount of the innovation in the field falls within the LDT silo.

If the current 15 year, heavily-regulated drug development process is any indication of the success and expediency of the FDA's regulatory authority, I think we're in for a bumpy ride and significant delays in diagnosis of genetic diseases. That can't be good for patients. On the flip side, I think we can all appreciate the need for standardization and an "apples to apples" approach to diagnostics in medical practice. So how should we think about this public move by a public company?

Well...what does Genentech stand to gain? OR more importantly, what do Combimatrix, Monogram, Clinical Data, Genomic Health, Response and others practicing non-DNA approved LDT tests stand to lose?

Genentech's soon to be parent, Roche Holding AG, may be providing the motivation. Roche's hostile $3 billion cash offer for Ventana Medical Systems Inc. last year underlines the Swiss health-care company's strategy of acquiring midsized and small companies whose diagnostic products allow it to target drugs to individual patients. Roche also acquired NimbleGen, a maker of high-density DNA microarrays, tools used in pharma research to understand the genetic causes of disease and the identification of potential drug targets. In April of last year, Roche agreed to buy BioVeris Corp., a U.S. diagnostics company, for $600 million and also recently bought 454 Life Sciences Corp. a maker of sequencing products for diagnostic tests.

It appears Roche/Genentech are trying to use this broad public appeal to protect their investment and break the back of small companies with revenues from LDTs. In this pernicious fundraising environment they will likely not survive regulation. Read: the losers may be the cash-starved start-up companies providing high-quality LDTs and surviving/developing new tests via those early testing revenues.

I think its safe to assume that any FDA regulation at this point will slow progress, limit/delay disease diagnosis, stymie small business innovation, etc. Is that a good thing? Is NOW the right time for this legislation to be enabled/enacted? Or should we let things mature a bit more?

If you need evidence that the FDA process will delay new commercial products without taking all the risk out of the end product just think (Vioxx, Celebrex, Fen-Phen, etc) and see the graphic at the right...

Wednesday, December 3, 2008

Biobanking has long-term consequences and a few, intangible near-term benefits

In today's genomics community few would argue that a million SNP chip analysis yields "hard evidence" of disease or a particularly high-degree of clinically and medically relevant pre-disposition information. SNPs might rather be applied as guideposts of "hints to dig deeper". So why are we broadly consenting patients and biobanking blood samples without access to tools that can more definitively diagnose disease or predisposition to disease?

On December 9 at 2:00 p.m. EST Kathy Hudson and her group at the government backed Genetics and Public Policy Center are putting on a seminar named: "Genetic Biobanks: Deposits, Withdrawals, and Consumer Protection” at the National Press Club in Washington, DC to dig deeper on these issues.

From my view, taking biological samples from broadly consented patients to perform SNP studies does enable much needed research but biobanking also leaves patients open to a quagmire of more sophisticated future analyses (CNV analysis, epigenetics, etc). More advanced interrogation of the old sample could expose things about the patient that we/they haven't anticipated. These patients, not being privvy to advances in diagnostic technologies or disease associations, may not have otherwise consented to the new tests, AND they may learn things no one could have foreseen. Consider: not only their physical health but also their mental health...their social health/fitness...

While now outdated, a 2005 paper by Caitlin Jones from the Rochester Institute of Technology on "Genetic and Environmental Influences on Criminal Behavior" shows the possible link between genetics and sociopathic behavior.

I wonder if the consented and later potentially de-indentified patients would want anyone to know they have a pre-disposition to Attention Deficit Hyperactivity Disorder (ADHD), Conduct Disorder (CD) or Oppositional Defiance Disorder (ODD)?

How do we prospectively write consents to anticipate technological changes? How do we inform patients of these kinds of unanticipated results? It is a physician's duty, no? Or will we distribute the results ONLINE...DTC?

Monday, December 1, 2008

Welcome to our new site covering genetic discrimination issues

If GINA protects Americans from discrimination starting mid-year next year, what about all the people taking genetic tests this year? What happens to the information captured on those people?
The NHGRI says: "The law does not cover members of the military. In addition, the law does not cover life insurance, disability insurance and long-term care insurance."

Since GINA is designed only to prevent discrimination by health insurers and employers I'm wondering why did they make the law so narrow from the outset?Why not include Life Insurers, military personnel, etc?