CLINICAL TRIALS AND HOW TO FIND THEM

Where?  When?

Kalamazoo?

 

File this one away somewhere.  With any luck you will never need it, but if you do – here it is.

 

How to find a clinical trial:  When Linda was diagnosed with stage 3c epithelial ovarian cancer neither she nor I knew what that was, nor what to do about it.  We knew that things called clinical trials existed, but we didn’t know how to find them or whether they could be trusted, let alone would do her any good.  We relied on our oncologists for guidance – and, sad to say, we didn’t get much.  Knowing about and utilizing clinical trials probably wouldn't have saved her, but then again, who really knows?.  So, you should  know about clinical trials.

To find a clinical trial in your vicinity, simply go to the NIH web site “Clinicaltrials.gov”.  It is easy to use, up to date, and exhaustive.  Were Linda alive today I would go to that web site and type in “ovarian cancer and Seattle”.  This request would return 130 studies, of which 24 currently are recruiting.  (The rest are either full or recently completed.)  Clicking on any of the 24 would give me who to contact, as well as a description of what the investigator(s) are trying to find out.  Searching on “ovarian cancer and Bellingham” returns 12 studies, three of which are open.  And these examples are based on using “basic search”; there is a button for “advanced search” that can narrow the possibilities down much further.    

Note that many of these trials are run by drug companies.  Before you shudder and turn away in disgust: they are supervised by the NIH and most of them have academic researchers on staff.  You may not like drug companies (really, who does?) but we damned well still need them.

I hope this turns out to be useless information.



WAKING UP DYING

In better times

 

Here is a tough one to read.  Tough, but we all should read it.  I’m trying to muster the courage to read his book.

http://www.bellinghamherald.com/2014/07/28/3765206/bellingham-writer-recounts-ups.html?sp=/99/100/&ihp=1 

 

To cheer up I think I will go look at cute baby pictures on Facebook.

 

 



LINDA'S TEAM, 2014. The final report.

 

Patches knew a good lap when she saw one.

 

To start with the good news:  Linda’s Team skunked the Fred Hutch team.  We raised $1530 to their $1105.  Hooray for us, and thanks to all of you who donated.

The bad news?  I have 15 hotdogs and two dozen buns to freeze, plus enough beer and pop to last a year.  I guess I didn’t advertise the thing well enough, because only Karen and Florence showed up.  My cousin-in-law Pieter Berendson also was here; he cooked the hot dogs – all two of them.  Maybe next year I should go back to a full-fledged hard press to advertise the event.  I didn’t think I’d have the energy to do it this year, but in retrospect I was wrong.  Wait ‘til next year!



THE WOES OF BIG PHARMA

Linda and Carolyn, 1991

Nice shot.  Where at?

 

I have used up my quota of free articles from the NY Times web page, but maybe Dick Ingwall will keep me in the loop.  Inshallah!

My last article was an interesting essay on the woes of the pharmaceutical industry.  If you haven’t used your ten free peeks, you may be able to read it at:

http://nyti.ms/1nkg1x5

Again, Inshallah!  (I am reading a spy novel that uses lots of Arabic ejaculations.) 

So, apparently the pace of innovation in the pharm industry has slackened rather dramatically.  The reasons seems to be economic as well as regulatory.  It costs so much to develop mass-market drugs that Big Pharma often despairs of recovering their investment, let alone of making a profit, before their patent runs out and generics take over 80% of the market.  Also, some new drugs cost so much that medical insurance plans won’t cover them.  (Try $84,000 per dose for a new “blockbuster” drug for hepatitis C.) 

Oddly enough, the exception to this dearth of innovation seems to revolve around the so-called “orphan drugs”, which are drugs developed to confront diseases (including several kinds of cancer) that are exceedingly rare.  Apparently the FDA permits smaller and cheaper clinical trials for these drugs, because there are too few sufferers to people a full-size Stage 3 clinical trial.  Also, the insurance companies are less reluctant to pay for such drugs – often costing $100,000 or more per treatment – because there are so few potential claimants.    

As one wag put it, “more people are studying orphan diseases than actually HAVE orphan diseases.”

FYI:  Linda’s Team trails Fred Hutch by $5.00 as of this morning.  Remember – I will (grudgingly) match anything you contribute .    http://community.swedish.org/summerun/2014/2014-summerun----team-page?tab=0&frtid=1657

 

 



HOW ABOUT SOME REAL PROGRESS?

 

Linda and friend under the protection of Horus

Unfortunately, he let her down

 

If it were possible to crush cancer under the weight of published scientific papers, cancer would already be history.  To avoid doing housework I have spent the morning playing with my computer, specifically with Google Scholar.  Just now I asked GS to look for scientific papers with the phrase “epithelial ovarian cancer” in their titles, published since 2013.  Eighteen months’ worth of the finest thought by ovarian cancer experts!  The program returned 714 papers!  I also asked for papers during the same interval of time that had that phrase anywhere in the article.  The return: well over 4,000! 

And yet, as one paper put it, epithelial ovarian cancer continues to represent “late presentation and stagnant mortality statistics.”  In other words – for all this effort, and for all the money expended, we are getting essentially nowhere.  If you don’t believe me, read Clifton Leaf.  What to do?



HEATHER HAS A MOMMY AND DADDY - AND ANOTHER MOMMY

The Yukon, July, 1991

Picture was taken at 10:00 p.m.  Glad I bought that flashlight!

Boy, have I ever got a treat for all you genetics/biochemistry freaks following  my blog! (Especially you folks in Turkey,  Moldova and the Ukraine.)   An article you will love appeared recently in the “Magazine” section of the NY Times: you can read it at:

http://www.nytimes.com/2014/06/29/magazine/the-brave-new-world-of-three-parent-ivf.html?ref=health&_r=0

To understand what follows, you have to recall the meaning of the following:

Cytoplasm:  The goop in a cell outside the nucleus, comprising all sorts of things including organelles called…

Mitochondria:  Tiny, membrane-enclosed packages that produce energy by the breakdown of sugars.  Contained within the mitochondria is a short strand of DNA, called miDNA.

I.V.F:   In-vitro fertilization, wherein an egg is extracted from a female, fertilized in a test tube, then re-implanted in the uterus.

Parents:  Individuals who contribute DNA to a …..

Zygote: A single omnipotent cell capable of transforming itself into a human being.  (Or, if it is a goat zygote, into a full-fledged goat  You get the picture..)

Anyway, the article describes research aimed at (1) enhancing fertility in women who have a hard time getting pregnant, and (2) curing some very nasty diseases that occur when the mitochondria misbehave owing to mutated miDNA.  The fertilization part of the “experiment” has been going on for a long time; fully healthy and highly functional children have been the result (although several “failures” are noted.)    The second goal has been pursued for a shorter time & the jury seems still to be out.

What these guys do is something like this.  They take a fertilized egg, extract the cytoplasm (how, for God’s sake!), then replace it with cytoplasm extracted from the egg of another woman.  This, then, is implanted in the proper place (I.V.F) and allowed to reach maturity.  The result: should  be a child whose cells contained the nuclear DNA of her mother and father – and the miDNA of another  woman.  Characteristics such as height, hair color, smarts, etc. would be the result of DNA from the mother and father (plus environmental effects, of course), but the little mitochondrial power plants would be inherited from a stranger.  So?

Well, note that mitochondria are inherited exclusively from the mother.  Thus, the “stranger miDNA” conceivably could echo down the corridors of time, “even to the nth generation.”  Is that bad?

Well, hell, I couldn’t figure out what the problem actually is.  It seems to have a large moral/philosophical dimension.  The article is long, and when I get the clothes washed I will read it again.  In the meantime, enjoy!



LINDA'S TEAM: SummeRun 2014 (not)

Somewhere in southern Utah

When?  Where?  Who took the picture?

My taste in beer was rotten; my taste in women, unexcelled.

 

Well, heck.  Earlier (I Wimp Out: 7/4/14) I confessed to being too old and useless to stage a full-fledged Summerun North this year.  I did say that there would be a Linda’s Team to which you can donate, and – impulsively – I set a $2000 fund-raising goal.  So far there is exactly $75 in the coffers, and I am beginning to worry.  Since gas is so expensive you aren’t going to travel this summer, so you have money to burn.  How about making a small donation? – and I will match it!  (Until the goal is reached, of course.)   Direct-line descendants  should particularly note that any excess I have to contribute comes directly out of their inheritance.  No donation too small:  if 200 of you give $5 each we will go over the top.  Here is the web address.  Remember to “Donate” – do not “Join” the team.

http://community.swedish.org/summerun/2014/2014-summerun----team-page?tab=0&frtid=1657

Actually, if you want to join you can do so, but then you will have to fork over an additional $25 – which I darned well will not match!





THE ORACLE SPEAKS

The "road" to McCarthy, Alaska

1991

 

 

The Wall Street Journal turned 125 today, and celebrated by issuing an edition that would take two weeks to read.  Included in this mass of newsprint is an article by Dr. Francis Collins on the future of medicine.  Dr. Collins is current head of the National Institutes of Health, so if anybody should know, he's the guy.  He predicts across-the-board increase in “personalized” medicine, based on gene sequencing.  If he is right, newborns will have their DNA sequenced almost at birth, and a lifelong health-maintenance program established before they are weaned.  He foresees increased use of stem cells to hasten bodily repair, and even to replace entire defective organs.  He is confident that TCGA (The cancer genome atlas) will hasten the demise of cancer.  And so forth.

One hopes he is right.  The cost of all this is, of course, stupendous.  By his estimate, in the year 2020 health care will eat up fully 20% of GDP (up from 18% in 2013.)  And, as you might expect, he ends with a plea for more money for health-related research.

It is hard to disagree with Dr. Collins.  I would only add that NIH owes it to society to reform itself so that innovative projects get more support.

Unlike the NY Times, the WSJ  is reluctant to let just any old body  read their articles on line for free.  As a subscriber I can get them, but whether or not you can is debatable.  Anyway, here is the web address:

http://online.wsj.com/articles/francis-collins-says-medicine-in-the-future-will-be-tailored-to-your-genes-1404763139?KEYWORDS=the+future+of+medicine+is+now

 



LIES, DAMN LIES, AND CANCER STATISTICS

Linda with Whiskers, Patches with me

1989

 

Somehow I got on the email list of Lancet, which is a British publisher of medical articles.  Rarely a week goes by that I do not receive notice of a new issue, containing many articles, some of which sound interesting.  Unfortunately, Lancet is not in this game for love; they want $31.50 to read each article, or about $200 for a yearly subscription.  As the odds are strongly against me being able to actually understand any given article, I do not bite.  However, I have discovered a way to out-fox them.  It appears that most important articles generate “Comments”, which I can read in their entirety, for free!  Thus, with a little imagination I can reconstruct the article in question – or at least get a handle on its more controversial parts.  This I did for two Comments on a paper dealing with the labeling of early pre-cancerous lesions.

As cancer doctors apply more and more early detection techniques they find more and more things they call “lesions”, which may or may not develop into cancer.  The argument seems to concern what to call them.  If you call them pre-cancerous lesions you scare the hell out of the patient, who immediately insists on treatment - which costs money and entails greater or lesser discomfort.  If you call them something else the patient doesn’t worry and unnecessary expense is avoided.  However, if one of these things develops into cancer and the patient dies, all hell – in the form of malpractice suits – may break loose.  What to do?

Well, they are arguing about that.  In the meantime, notice what this dilemma does to cancer statistics.  If you label a bunch of these lesion things “cancer” – when many of them aren’t – then it appears that the survival rate for that particular cancer is high.  And, of course, vice versa.  Another reason to be suspicious of cancer statistics.



I WIMP OUT. No Summerun.

Linda at 33

Wasn't she beautiful?

 

 

I am afraid I must wimp out on SummeRun North – I just haven’t got the energy to organize a full-fledged event.  However, I will be home on July 28^th, and the grill will be on.  I invite you all to stop by.  Bring some food, or rely on me to cook some hotdogs. 

There IS a Linda’s Team, however.  If you want to donate, go to this web address:

http://community.swedish.org/summerun/2014/2014-summerun----team-page?tab=0&frtid=1657

and remember to DONATE, not JOIN.  If you want to say something about Linda you can use the message board at the web site.



We need more FORCE

During chemo

 

Back on June 11, 2013 I introduced you to FORCE: Facing Our Risk of Cancer Empowered.  It is an advocacy group, helping women with inherited mutations of the genes BRCA1 & BRCA 2.  These genes code for proteins that are important in fixing errors introduced during cell replication.  As you know, whenever a cell divides it must duplicate its entire collection of DNA   Given that the number of nucleic acids that must be duplicated extends into the billions, the process is remarkably efficient.  Nevertheless, some mistakes are made.  The BRCA genes provide tools to help fix those mistakes. Absent functional BRCA genes, ovarian and breast cancer are much more likely to result.  The mission of FORCE is to further the detection and treatment of women with defective BRCA genes. 

FORCE recently testified at a hearing of something called the ODAC, which is the Oncological Drug Advisory Committee of the FDA.  The subject of the hearing was a drug called olaparib.  Specifically, FORCE (and others) wanted this drug approved for use in the case of BRCA 1,2 -positive women.  Research long in progress has shown that this drug – a PARP inhibitor, also involved in DNA damage repair – extends "Progression Free Survival" in women with advanced ovarian and breast cancer; that is, it enhances quality of life, and postpones death.  However, the available evidence did not demonstrate with sufficient statistical rigor that olaparib affects” Overall Survival.”  It seemed to prolong life, but not enough to be “significant”.  So ODAC turned them down;.  “More research is needed.”

Okay, this leaves me with a dilemma.  I am on record as wanting to throw dead cats at people who claim a “major breakthrough” for drugs or therapies that merely shrink tumors or extend life for a few miserable weeks.  On the other hand, I lived with a woman who died of ovarian cancer.  After chemo she had a prolonged period of remission; long enough to re-grow her hair, feel good, and go on several wonderful trips.  Those nine or ten months were amongst the best of our lives together.  So, if olaparib will extend remission by another six months or so, why in hell not use it while the “more research” is going on?  "First, do no harm."  Bullshit!  I don’t understand.

There is an obvious problem here, but I don’t know what to suggest.  Maybe you should consider joining FORCE, or at least getting on their mailing list.  I wish I knew a way to help clean the sludge out of the arteries of the FDA, but I don’t.

Here is the FORCE blog.  http://facingourrisk.wordpress.com/2014/06/29/fda-approval-of-promising-targeted-therapy-likely-stalled-until-more-research-studies-are-completed/