Corante

About this Author
DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

Chemistry and Drug Data: Drugbank
Emolecules
ChemSpider
Chempedia Lab
Synthetic Pages
Organic Chemistry Portal
PubChem
Not Voodoo
DailyMed
Druglib
Clinicaltrials.gov

Chemistry and Pharma Blogs:
Org Prep Daily
The Haystack
Kilomentor
A New Merck, Reviewed
Liberal Arts Chemistry
Electron Pusher
All Things Metathesis
C&E News Blogs
Chemiotics II
Chemical Space
Noel O'Blog
In Vivo Blog
Terra Sigilatta
BBSRC/Douglas Kell
ChemBark
Realizations in Biostatistics
Chemjobber
Pharmalot
ChemSpider Blog
Pharmagossip
Med-Chemist
Organic Chem - Education & Industry
Pharma Strategy Blog
No Name No Slogan
Practical Fragments
SimBioSys
The Curious Wavefunction
Natural Product Man
Fragment Literature
Chemistry World Blog
Synthetic Nature
Chemistry Blog
Synthesizing Ideas
Business|Bytes|Genes|Molecules
Eye on FDA
Chemical Forums
Depth-First
Symyx Blog
Sceptical Chymist
Lamentations on Chemistry
Computational Organic Chemistry
Mining Drugs
Henry Rzepa


Science Blogs and News:
Bad Science
The Loom
Uncertain Principles
Fierce Biotech
Blogs for Industry
Omics! Omics!
Young Female Scientist
Notional Slurry
Nobel Intent
SciTech Daily
Science Blog
FuturePundit
Aetiology
Gene Expression (I)
Gene Expression (II)
Sciencebase
Pharyngula
Adventures in Ethics and Science
Transterrestrial Musings
Slashdot Science
Cosmic Variance
Biology News Net


Medical Blogs
DB's Medical Rants
Science-Based Medicine
GruntDoc
Respectful Insolence
Diabetes Mine


Economics and Business
Marginal Revolution
The Volokh Conspiracy
Knowledge Problem


Politics / Current Events
Virginia Postrel
Instapundit
Belmont Club
Mickey Kaus


Belles Lettres
Uncouth Reflections
Arts and Letters Daily
In the Pipeline: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

In the Pipeline

« Ariad's Patent Rises From the Grave to Smite the Living | Main | Rings of the Future! »

August 26, 2009

Thalidomide for Myeloma: Whose Idea Was It?

Email This Entry

Posted by Derek

So, if you're a patient with a rare disease (or a relative of a patient with one), and you have an idea for repurposing an old drug for treatment. . .and you get a company interested, and it actually works. . .works to the point that the company takes in a billion or two dollars a year. . .what then?

Some readers will have guessed that I'm talking about thalidomide and Celgene, and right they are. Beth Jacobsen is the person involved - her husband died of multiple myeloma, but her medical sleuthing had turned up the idea of using thalidomide as a therapy for the disease, and she kept up the pressure to have the idea tried out. Celgene's mentioned her in annual reports, and she's been thanked by name in a publication on the clinical results.

But now she's suing Celgene, saying that they misappropriated her idea. Complicating the issue is the question of whether the late Judah Folkman was really the source of the inspiration, in a phone conversation with Jacobsen (earlier versions of the story have it that way, but the lawsuit apparently tells it differently). Which way did it happen? Is Jacobsen indeed owed compensation? And whether she is or not, will she be able to convince a court? Matt Herper has the story at Forbes.

I'll defer my own comments until I know a bit more about the case, but this is definitely an interesting one. I can add something that might be of relevance, though: a search in PubMed for "thalidomide myeloma" turns up 64 pages of references, almost all of them post-1999. But there is this one, from Italy in 1963. Has the idea been around for that long? Someone who can track down that journal can tell us. . .

Comments (20) + TrackBacks (0) | Category: Cancer | Drug Development | Drug Industry History | Patents and IP


COMMENTS

1. Phil on August 26, 2009 11:27 AM writes...

If the idea has already been published, then doesn't Jacobsen have no rights whatsoever to demand compensation for the idea? I'm not a patent attorney, but that's my understanding of intellectual property. If it's in the public domain, then it's fair game.

Permalink to Comment

2. HelicalZz on August 26, 2009 11:28 AM writes...

What???

If it didn't work, would Celgene shareholders been able to seek compensation from Beth Jacobson for funds lost to development? Did she take any financial risk to see this through? Did she make a material contribution to a patent, or direct any research?

Sorry Beth, but unless there was some financial arrangement that wasn't followed through on, you are almost certainly not owed any money.

Zz

Permalink to Comment

3. Dave on August 26, 2009 11:34 AM writes...

IP law is very strongly and intentionally biased against people who say "Here's an idea. I think it's good, but can't do anything with it. You try it out and see whether it works!". There's very little societal benefit to be gained by encouraging that sort of thing, as it is evidently produced in more-than-adequate supplies even if uncompensated.

Permalink to Comment

4. Phil on August 26, 2009 11:42 AM writes...

I think it's pretty obvious that she's not going to win anything in the lawsuit. I just wonder what terrible lawyer encouraged her to go through with this.

Sorry about the double post.

Permalink to Comment

5. alig on August 26, 2009 11:57 AM writes...

So if a patient lobbies for an off-label use of a drug, they are entitled to compensation based on sales of the drug for this indication, but if a pharma company lobbies for an off-label use, they have to pay fines for illegal promotion?

Permalink to Comment

6. Phil on August 26, 2009 12:13 PM writes...

I just read the Forbes article, and now it makes sense. Beth Jacobsen is the terrible lawyer that talked Beth Jacobsen into doing this.

My guess is her feelings about the situation have clouded her judgment, or she is a lawyer who is incredibly ignorant of law outside her own focus.

Permalink to Comment

7. WEIRDO on August 26, 2009 12:35 PM writes...

Well, it's pretty clear nobody stole nothing. She virtually begged Celgene to try this out.

BUT: Celgene didn't do itself any favors by not rewarding her. What if, several years ago, they had made a very public gift of $5-10M to some myeloma foundation? And a check of $1M to Jacobsen herself? Probably no story today.

Permalink to Comment

8. Lucifer on August 26, 2009 12:38 PM writes...

Why not give her a few million?

I mean, she did more than many MBAs sitting on Celgene's board? Most of those sociopaths are there only because they could talk BS and knew the right people.

For all those "scientists" who think paying her is wrong, but paying an MBA in admin is good. Wait till those same people downsize you..

Permalink to Comment

9. john.spevacek@aspenresearch.com on August 26, 2009 1:01 PM writes...

Search for the same terms in google scholar and restrict the search period to before 1997 and you'll find 177 hits, with 81 of them before 1990.

Permalink to Comment

10. Sleepless in SSF on August 26, 2009 1:03 PM writes...

I think it's interesting that she has decided to sue now that Judah Folkman is no longer with us. Dead men tell no tales?

Permalink to Comment

11. Sujoy on August 26, 2009 1:45 PM writes...

The current case has more 'human' overtones than a pure business/IP argument so public furore is a likely fallout (as we are seeing). To my understanding, the use of Thalomid for MMyeloma is a novel, non-obvious application (with clear commercial merit) that, in some (significant) measure, owes its success to Beth. Plus, Beth could (by some stretch), argue that she was 'lead on' by Celgene, thus lending more credence to her stance as an aggreived party. Plus, Celgene did offer her positions on the board, pursued her for it across two different senior management people, and then suddenly withdrew upon her agreement. Finally, Celgene's Sales figures prove Thalomid in MMyeloma's good/fruitful therapy. So, settling with Beth is probably not such a bad idea after all. Currently, the entire drug-related space could use lesser references alluding to 'panic and public hatred' anyway.

Permalink to Comment

12. Chrispy on August 26, 2009 2:12 PM writes...

Regardless of the merits of the case, Celgene will probably pay to make it go away and not deal with the public embarrassment of litigation.

The settlement amount will not be disclosed and Ms. Jacobson will stay very quiet on the matter. Case closed.

Permalink to Comment

13. d on August 26, 2009 3:19 PM writes...

Absolutely agree with #10:

From the Forbes article:
"In some previous press accounts of Jacobson's phone call with Judah Folkman, including one published in Forbes, he is the one who suggests thalidomide as an option. In her current lawsuit, the story is told somewhat differently. The filing says that he mentioned thalidomide as one option in childhood leukemias, but that using it in myeloma was her idea. Folkman died last year"

Permalink to Comment

14. Bruce Hamilton on August 26, 2009 8:51 PM writes...

I don't understand patent law, but would she be able to invalidate any relevant patents, if she can demonstrate that she contributed, but was left off the patent?.

Presumably, if she suggested thalidomide, she may be able to document that she had specifically searched for the drug/disease combination before the phone conversation.

Not enough information, so only speculation for now....

Permalink to Comment

15. Philip on August 26, 2009 10:18 PM writes...

I seems to me that thalidomide was first revived for treatment of leprosy. And then they tried it for everything else. I don't see the case for Mrs. Jacobsen.

It always looked like a reactive molecule to me especially nestled down in a hydrophobic pocket somewhere. I doubt it's pharmacology is very clean.

Permalink to Comment

16. gyges on August 27, 2009 3:08 AM writes...

Off topic. Mindhacks discusses the placebo effect.

"Wired has an excellent article on how the placebo effect is increasing in drug trials and how drug companies are trying to understand why. It's an intriguing article but it conflates two distinct concepts of 'placebo' that need to be separated to fully understand the effect."

Permalink to Comment

17. alig on August 27, 2009 7:40 AM writes...

Mrs. Jacobsen lobbied doctors to use Thalidomide off-label and if Celgene then compensates her for this, wouldn't they be guilty of violating FDA promotion guidelines. Or can pharma recruit "volunteers" to promote off-label indications and then reward them later for their great efforts to expand the drug use to new areas of "need."

Permalink to Comment

18. petros on August 27, 2009 8:40 AM writes...

Well Celgene has been in court before over thaldiomide. It reached a settlement with Entremed who had claimed it, and related compounds, for a number of uses.

Permalink to Comment

19. Cellbio on August 27, 2009 2:15 PM writes...

and Entremed was a company founded on Folkman IP.

Permalink to Comment

20. Aidan on September 1, 2009 5:20 PM writes...

my understanding from reading the literature (and CELG's regulatory filings) a couple years ago was that until Folkman et al replicated the limb bud damage phenotype in rabbits [PNAS, 1994, PMID: 7513432] (no phenotype in rats, which is why the reprotox in the '60s missed the side effect), there was no clear sense that thalomid had anti-angiogenic properties or would be appropriate in myeloma. The FDA pushed Celgene to file for leprosy mainly around concerns that AIDS buying clubs were illegally importing knock-off thalomid from Brazil and that further birth defects were going to occur.

Permalink to Comment

POST A COMMENT




Remember Me?



EMAIL THIS ENTRY TO A FRIEND

Email this entry to:

Your email address:

Message (optional):




RELATED ENTRIES
Molecular Printing of Drug Molecules. Say What?
Pfizer Walks Again By Night
Gitcher SF5 Groups Right Here
Changing A Broken Science System
One and Done
The Latest Protein-Protein Compounds
Professor Fukuyama's Solvent Peaks
Novartis Gets Out of RNAi