[Ip-health] BMJ: More drugs originate outside the industry than it claims

Biotech. Info. Inst. biotech at biopharma.com
Mon Feb 24 09:18:17 PST 2014

I see no contradictions:  Research-intensive organizations do the great majority of the origination (research, discovery and invention); pharmaceutical companies do essentially all commercial development (as claimed by ABPI here — "industry
was responsible for developing 90% of the drugs available to patients").  [Note, I have been unable to access the full article].

The reported data show industry (companies of all sizes) as the origination source for 76% of products.  If funding sources (and related patents and ownership) were considered, a claim of 90% origination from industry (but not Big Pharma-type) sources would likely not be off by much, and could even be accurate.  Any views from list members on how consideration of funding/sponsorship would affect the results? 

To me, 49% origination (discovery, invention) of new approved drugs from Big Pharma-type companies seems too high (I’d guess ≥40%), while the figure would be much higher, well over 50%, if funding sources/licensing/ownership were taken into account, including pharmaceuticals from some or many of the smaller companies and, likely, a few academic sources.  

[Does this analysis, like CDER/FDA’s own and most other analyses of FDA annual approvals, ignore most biologics approvals (making them worthless or misleading, which most people don’t realize)), i.e., only count recombinant and maybe other pure protein products (CDER approvals), while omitting/ignoring most classic biologics (CBER approvals), particularly, non-recombinant vaccines, blood and plasma products, cultured cells/tissues, etc.?  Keep in mind that the great majority of U.S. approvals analyses are like those released by FDA itself, i.e., simply omit most CBER-approved biologics, particularly when considering new molecular entities.  For a running list of new U.S. biopharmaceutical approvals see www.biopharma.com/approvals.html].

Thank you.

Ronald A. Rader
Biotechnology Information Institute
1700 Rockville Pike, Suite 400
Rockville, MD 20852
Phone:  301-424-0255
Web sites:  www.biopharma.com; www.bioinfo.com;
   www.biosimilarspipeline.com; www.biopharmacopeia.com

On Feb 24, 2014, at 6:49 AM, Thiru Balasubramaniam <thiru at keionline.org> wrote:

>   1.
>      1. http://www.bmj.com/content/348/bmj.g1354
>      2.
>      3. NEWS
>      More drugs originate outside the industry than it claims
>      2. Jacqui Young
> Many innovative drugs, especially to treat rare diseases, originate not
> from large drug companies but from small enterprises or academia, a new
> study has shown.
> The research by the European Medicines Agency shows that 44% of innovative
> drugs recommended for marketing authorisation in the European Union
> originated from small or medium sized enterprises, academia, public bodies,
> and public-private
> partnerships.1<http://www.bmj.com/content/348/bmj.g1354#ref-1>
> This seems to contradict the claim by Stephen Whitehead, chief executive of
> the Association of the British Pharmaceutical Industry, that the industry
> was responsible for developing 90% of the drugs available to
> patients.2<http://www.bmj.com/content/348/bmj.g1354#ref-2>
> The study, published in *Nature Reviews Drug Discovery*, identified all the
> drugs containing a new active substance that were recommended for marketing
> authorisation between 2010 and 2012 by the European Medicines Agency’s
> Committee for Medicinal Products for Human Use. The researchers identified
> 94 drugs, of which 18 were “orphan” drugs developed to treat rare diseases.
> When the researchers tracked the products back through development to their
> origin, they found that large or intermediate sized drug companies
> accounted for 49% of the drugs. Another 27% originated from small or medium
> enterprises and 17% from academic institutions, public bodies, and
> public-private partnerships. Private-private collaborations accounted for
> 7% of the products.
> The researchers found that 61% of orphan drugs originated from small or
> medium sized enterprises, even though these organisations held the
> marketing authorisation in only a fifth of cases. The study also found that
> 11% of orphan drugs originated from academic institutions, public bodies,
> and public-private partnerships, although these organisations were no
> longer involved at the stage of application for marketing authorisation.
> The researchers wrote, “Overall, although large and intermediate-sized
> companies still represent the main engine for commercializing new
> medicines, SMEs [small and medium sized enterprises], academic
> institutions, public bodies and PPPs [public-private partnerships]
> represent an important source of innovation and enrich the product
> pipelines of larger companies.”
> The agency said that it had a programme in place to support small and
> medium enterprises throughout all stages of drug development so as to
> promote the emergence of innovative drugs.
> The study also found that 45% of the original research leading to the
> products occurred in North America and 37% in Europe. International
> projects, mostly transatlantic collaborations, accounted for 8%, and other
> countries (such as Japan, China, Israel, and Australia) accounted for the
> remaining 10%.
> Iain Chalmers, one of the founders of the Cochrane Collaboration and
> coordinator of the James Lind Initiative, said, “The chief executive of the
> ABPI [Association of the British Pharmaceutical Industry] has claimed more
> than once that 90% of new drugs come from industry, but he doesn’t provide
> evidence to support this claim. He appears to overlook the substantial
> contribution of publicly funded university departments which have made the
> discoveries that have led to new drugs.”
> Notes
> *Cite this as:* *BMJ* 2014;348:g1354
> References
>   1. ↵ <http://www.bmj.com/content/348/bmj.g1354#xref-ref-1-1>
>   Lincker H, Ziogas C, Carr M, Porta N, Eichler H. Regulatory watch: where
>   do new medicines originate from in the EU? Nat Rev Drug Discov 31 Jan
>   2014, doi:10.1038/nrd4232 <http://dx.doi.org/10.1038/nrd4232>.
>   2. ↵ <http://www.bmj.com/content/348/bmj.g1354#xref-ref-2-1>
>   Whitehead S. Transparency in pharma and healthcare [blog].
>   http://blogs.bmj.com/bmj/2012/06/08/stephen-whitehead-transparency-in-pharma-and-healthcare
>   .
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