ABC, Misinformation and Government Regulation

I have to comment on something. ABC news tonight covered the whole drama in California.....But they really didn't. In fact they gave 20 seconds (approx) to the fact that the government was finally regulating this industry....they did even manage to squeeze in that the FTC is investigating deceptive advertising.

What the piece really was.......A human interest story....much like the excellent work done by Amy Harmon at the NYT....Which reminds me....did anyone see Kathy Hudson throw the Federal Gov't under the bus???? She now really has put them on notice and put their backs slammed against the wall.

So the ABC report?

52 year old woman caring for her mother with Alzheimers.

The pitch

"I am taking an at home test to find out what my risk for Alzhemier's"

Whoa!!!!! No one....I mean no one mentions the limitations of the test she used from....You Guessed it AlzMirror!!!! ApoE e4 testing.

In fact George says "Some tests show increased risk for a disease, then you can do something about it" The problem....they then freakin show a guy getting a colonoscopy....That is not even a close comparison

To even implicate that Alzhemiers and ApoE e4 might have the same screening and prevention as hereditary colorectal cancer is preposterous. And you wonder why the government is stepping in???? The press just made the public link the two!

Hey ABC, Next time you cover this, give the Sherpa a call!

Instead of the Sherpa....ABC picks Francis.....a wise choice....I would have jumped down the journalists throats...

I think the Good Dr Collins even quotes me.........."Genetic Snake Oil" or the other few people who used this term last year....

But, they only put Francis on for 30 freakin seconds!!!! Are you kidding me? Elissa Levin gets more screen time than him. In addition, Elissa sits down and goes over results IN PERSON on the show......Do they do that for people who test (Sorry, they don't test, they do analysis of their Non-Medical DNA data that includes risks of medical conditions) with Navigenics? I did notice, 23andMe weren't in the report....

Their participation was really minimal.....as I said this was a human interest story. What really got me was when this poor lady got her AlzMirror test results....

She said "This is great. I only have a 30% chance of getting Alzheimer's Disease"

This is the biggest crock out there! An negative ApoE e4 test is not definitive. The public now thinks that the DTC test can indicate risk of ALL Alzheimer's Disease...I am so blown away about this....Can you imagine???? Alzhemiers genetics is so confusing. There are reams and reams of data out there indicating family risk of Alzheimer's disease....It's heritability is something like 70-85%.

What was amazing, there is absolutely no commentary on the limitations of the ApoE e4 testing and the other genetics of Alzheimer's....Did they bother calling Rudy Tanzi???

I am so upset by this. That's why I am blogging.

So the real story

"But Collins says customers are getting predictions, not necessarily medical recommendations or prescriptions about what to do about the information. "

30 Percent huh?

Holly Hagy, 51, of New Haven, Conn you could have seen the geneticists at Yale.

Here are your real stats.......

1. One first degree relative with Alzhemier's disease? 500 fold increased risk......despite ApoE e4 status....Not 30% My God!!!

2. ApoE e4 is only one risk factor and is modified by other genes, there are other factors

3. Even the REVEAL study gave numerical estimates of risk based on FAMILY HISTORY!!!

4. Did you see the GWAS on Alzheimer's?

5. What about her blood pressure, LDL, stroke history....all of these things play a role.....too bad AlzMirror didn't tell her that!

6. Who can she sue for the malpractice she just received...No accountability by these guys.....that's another reason to involve healthcare!!!

Should ABC be pilloried on this one? I don't think so, but they should have vetted the risk prediction.

Because of this recent study!

"The pilot study showed that there was limited knowledge of genetics overall and AD genetics in particular, considerable concern about personal risk, and little knowledge of or interest in genetic testing for the disease."

ABC just increased interest and actually portrayed incorrect knowledge....way to go! And you wonder why the government is getting involved in DTC testing????

Smart Genetics got a letter.....Maybe ABC should too? JK

Ms. Hagy, please give us a call and we can put your ApoE e4 results into the proper context!

The Sherpa Says:

This is precisely why the government is stepping in guys....they can't allow the press to butcher it AND Hype it.........the companies to tell less than half the story and hype their tests..........the consumer to be duped into false statistics..............and Kathy Hudson to point out that the federal government has been asleep at the switch for the last 30 years......This is only gonna inspire more regulations....Or at least enforcement of the ones that exist......adjust it for new technology? Last time I checked, genetic tests have been around for over 2 decades.....

Newborn Screening for Alzheimer's Disease?

Don't Forget that Gene Genie is up at Neurophilosophy so check it out!

I want to thank the Connecticut Geriatric Socitey for inviting me to speak at their wonderful group's Annual Meeting. It was a lively time and the Salmon was excellent. At the end of the lecture we had a lively debate with several clinicians.

Family history is king when it comes to Alzheimer's Disease. APOE e4 testing is not super worthwhile, unless you identify ApoE e4 in an affected and then work the family up that way. But the 3 gene panel for Early Onset Alzhemier's is definitely a must. Provided the 3 tenets of Informed Consent are met.

What are those 3?

1. A plan of action for results. "What would you do if you had a positive or negative or uncertain test result?


2. Are you Psychologically prepared to handle the results. And do you understand the implications?

3. Do you understand the limitations of the test?


If those three things are met, then testing is likely going to be beneficial. Provided testing is medically indicated.

Here is where I see some shortcomings with this. Did you know that in the US every pregnant white woman is tested for CF carrier status once pregnant? Did they give informed consent? Usually no. It is just added to the panel of testing, much like the quad screen. There are some serious implications in the prenatal realm.

In Medical News Today there is a PR post regarding The Treuman Katz Center for Pediatric Bioethics at Seattle Children's Hospital hosting its fourth annual international bioethics conference on July 25-26, 2008 in Seattle.

This conference will cover some tough issues. Why? Because they need to be addressed. At the Geriatric Society talk, I was asked about pre-implantation diagnosis for Alzhemier's. There is a case report of PGD for Early Onset Alzheimer's with the gene APP. This poses some serious controversy..

Personally, I think this expresses a severe pessimistic view of adult onset disease and the likelihood of no better treatments for Alzheimer's in 30 years. Can you imagine that? It is alot easier when looking at a disease like Huntington's Chorea, where we have known the genetic issue for decades. True for APP Alzheimer's as well. So I ask you, is it such a stretch?

Issues to be covered include: From the Site

With technology rapidly advancing — bringing about more genetic tests — many ethical and policy questions must be addressed to appropriately use these new tools of genetic assessment in children:

• Which tests should be required of all newborns, and which tests should not be permitted until the child is an adult?



• Should parents be able to test young children for the risk of future diseases, such as breast cancer or Alzheimer disease?



• What obligations are there to inform family members about genetic test results that may impact them?



• What are the ethical implications of using genetic tests to predict behavioral traits, such as attention deficit disorder, addiction and depression?



• What are the ethical considerations of looking for a genetic predisposition for enhanced abilities, such as the potential for sports performance?



• What if adolescents and their parents disagree about genetic testing decisions?



• What genetic tests should be available to prospective parents before the adoption of a child?

A representative from Helix Health of Connecticut will be there. Hopefully it can arrange to have one of the MediCasts cover these topics.



The Sherpa Says:

Ethics, a class taught in all medical schools. Hopefully it was also taught in B-School. The Sherpa has been down this road before..... The Sherpa will be speaking at the Beyond Genome Conference on Tuesday. If you can come, please do.