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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

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October 11, 2011

Too Many Cancer Drugs? Too Few? About Right?

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Posted by Derek

According to Bruce Booth (@LifeSciVC on Twitter), Ernst & Young have estimated the proportion of drugs in the clinic in the US that are targeting cancer. Anyone want to pause for a moment to make a mental estimate of their own?

Well, I can tell you that I was a bit low. The E&Y number is 44%. The first thought I have is that I'd like to see that in some historical perspective, because I'd guess that it's been climbing for at least ten years now. My second thought is to wonder if that number is too high - no, not whether the estimate is too high. Assuming that the estimate is correct, is that too high a proportion of drug research being spent in oncology, or not?

Several factors led to the rise in the first place - lots of potential targets, ability to charge a lot for anything effective, an overall shorter and more definitive clinical pathway, no need for huge expensive ad campaigns to reach the specialists. Have these caused us to overshoot?

Comments (22) + TrackBacks (0) | Category: Cancer | Clinical Trials | Drug Development | Drug Industry History


COMMENTS

1. Aninymous BMS Researcher on October 11, 2011 8:24 AM writes...

I suspect among the reasons for this is the increased aversion to risk among regulators -- companies think, "if we can show that our new cancer drug extends lives of people who are nearly certain to die without it, the FDA will have to approve it despite possible side effects."

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2. Ed on October 11, 2011 8:40 AM writes...

I suspect that an overwhelming abundance of potential and mutated kinase targets has played a huge part in this. For small companies, it became *relatively* easy to find something sellable.

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3. Hap on October 11, 2011 9:18 AM writes...

The article below says that 14% of the drugs approved by the FDA between 1985 and 2004 were cancer drugs, and estimated R+D was about 15% of drug R+D:

Annals of Oncology 18 (Supplement 3), iii49-iii54 (2007)

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4. Vader on October 11, 2011 9:35 AM writes...

My suspicion is that the number of treatment options goes in inverse ratio to the effectiveness of the best treatment option.

Most of the oral hyperglycemics are reasonable effective. Thus, in spite of a huge market for Type II diabetes treatments, the number of oral hyperglycemics actually being used much can be counted on your fingers (and toes if you throw in some of the approved but not much used options.)

For many cancers, there's not a lot of reason for optimism even with the best chemotherapy. So the options multiply.

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5. johnnyboy on October 11, 2011 9:52 AM writes...

I think this relatively high number is due to the nature of cancer. It is always misleading to think of cancer as one disease with varying sites, as most people do. Actually every cancer type is a different disease (with usually many clinically and pathologically different cancers for every organ). Since a drug can be highly effective for one type of cancer and completely useless for another, the high number of cancer types means you need a wide range of drugs. Add to that the relative inefficacy of most cancer drugs, meaning better ones always need to be developed, and you will necessarily wind up with many drugs. I'm not sure why this would be viewed as a problem by anyone except bean counters.

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6. TJMC on October 11, 2011 9:56 AM writes...

This does not surprise me since a similar evaluation I did in 2007 revealed that over 50% of industry pipelines were devoted to anticancer candidates (counting candidates in P1-P3). I was helping several clients “optimize” their clinical image process to handle this emphasis. So this is kind of "old news". I wonder if E&Y was counting P3, which would explain the relatively lower total. That therapeutic area garnered the greatest proportion of sales per TA in the industry then, and I suspect it has only increased (as CV products became more and more generic.)

The points made above drove this trend; pricing power (which may be changing now…) far shorter and smaller trials, “simple proofs” (tumor shrinkage) of efficacy, less of an concern for long-term side-effects,... Take a look at the average duration of industry cancer trials vs. any other area. Especially unmet needs areas. Then consider the cost per patient/month and you will see why there has been an (over-?) investment in this area. I suspect this emphasis may be changing due to the realization of ROI to society and from the payor’s perspective – a recent hot topic.

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7. anchor on October 11, 2011 10:06 AM writes...

The heterogeneous nature of cancer cells, the role of kinase inhibitors when coupled with immense possibilities to cure with combination drugs are the reason why we have so many in the market place. These days the people are probed for the phenotype and then are recommended the right combination that works (in a way trial and error). I opine that given the increasing complexity of cancer, it is never going to be enough drugs.

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8. Jonny on October 11, 2011 10:30 AM writes...

jonnyboy and anchor are spot on, in my opinion.

The number of drugs in development for cancer is a function of the number of patients (very high), the inverse of current treatment effectiveness (very low, except for niche indications such as testicular), and the number of potential targets (very high).

No doubt you could refine that equation, but the point is that cancer kills a hell of a lot of people, can only moderately be protected against through lifestyle factors (lung cancer excluded), and is actually a collection of 100+ different diseases, featuring numerous mutated intracellular pathways.

Given all that, it's perhaps not surprising that there is so much out there.

A more interesting point is that it will not be possible to develop all of the oncoloy assets in development, there aren't the financial resources, patients, or clinicians to do so. Therefore there's going to be a lot of culling of inferior early stage programs, which again is as it should be.

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9. Design Monkey on October 11, 2011 11:09 AM writes...

Well, there is also theorem about cancer drugs:

Exactly half of all possible chemical compounds are potential cancer drugs.

Proof:

As noted by Paracelsus, any compound can be toxic depending on the dose.

Now, in cancer therapy, we need to poison away cancer cells, and leave normal cells alive.

If the compound kills normal cells faster than cancerous - bummer, it's just a generic poison.

If other way around - bingo, it's a potential cancer drug (a bad one, if the difference is not large enough, but still).

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10. pete on October 11, 2011 11:20 AM writes...

"Have these caused us to overshoot?"

YES, insofar as many cancer pathways/targets have become oversubscribed w/ respect to pending drug candidates.

And maybe YES again in that quite a few targeted oncology drugs have shown less universal promise than was originally envisioned, even though they may show excellent promise for select cancers.

And maybe YES once again if you consider that the incidence of several major cancers is strongly affected by lifestyle and environmental exposure.

But at the end of the day I'd say NO for a few reasons:
- there continue to be exciting new attack-strategies to test (e.g., cell metabolic pathways)
- cancer incidence has such a profound affect on society
- our expanding knowledge of cell biology (driven to a pretty large extent by cancer funding) will continue to have a major influence on the way we think about many diseases and our drug development decisions.
(...end of sermon)

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11. milkshake on October 11, 2011 11:21 AM writes...

the bar is very low for getting cancer drugs into clinic: You can run much smaller and shorter trials, alarming safety problems that would be a non-starter in other therapeutic areas are OK in cancer as long as you can show some modest clinical benefit (like terminal patients surviving with the drug 75 days longer on average).

Many of the approved drugs will become second- and third-line add-ons and will have narrow indication, and thus may not generate multi-bilion sales, but thats acceptable now in the post-blockbuster era, if the drug clinical development was not too expensive.

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12. anchor on October 11, 2011 11:43 AM writes...

Milkshake: well said. Previously, I missed mentioning what you just said in your posting. I am astounded that there is a lot of money for running clinical trial (in academia, most of it doled by NIH, NCI). It seems to me that any tom, dick, and harry with MD, Ph.D. and backed with sufficient knowledge can ask for and get funding to run clinical trial. Th trial, as you have just mentioned are short and typically involve 6 to 12 patients. To my surprise many of the drugs are the older one (off patent) that has failed in the past for cancer (as a stand alone) but getting another lease of life with "Kinase inhibitors". Amazing indeed!

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13. rcyran on October 11, 2011 11:52 AM writes...

About a quarter of all deaths in the US are from cancer. So prima facie, 44% seems too high.

Of course, cancer incidence should grow as population gets older, drug development clusters around hot R&D areas when the time is right, and reimbursement always plays a role. And as Milkshake points out, safety isn't a huge problem in cancer, since the alternatives tend to be grim. All of these factors seem favorable for cancer drug development.

My guess, however, is that there's too much being chased in cancer and too little in other areas.

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14. RespiSci on October 11, 2011 12:56 PM writes...

And I suspect the 44% will rise with the push for "personalized medicine". After all, soon we will all have our genomes sequenced for less than 100 dollars, right?

Seriously, I don't think 44% is too much. I am sure that we all have people in our lives who have been touched by cancer. And as discussed in this blog before, as little as we know about cancer, we are even less advanced in understanding the biology of other diseases (MS, Parkinsons etc)so let's take advantage of our what we do know.

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15. RD on October 11, 2011 1:16 PM writes...

You are looking at this from a scientific point of view and not a financial point of view.
Cancer drugs get approved more quickly. You don't have to get your knickers in a twist about toxicity. You can charge what the market will bear, and when people are dying, it will bear quite a bit. And the recipients are less likely to sue you later.
What's not to love?

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16. RD on October 11, 2011 1:16 PM writes...

You are looking at this from a scientific point of view and not a financial point of view.
Cancer drugs get approved more quickly. You don't have to get your knickers in a twist about toxicity. You can charge what the market will bear, and when people are dying, it will bear quite a bit. And the recipients are less likely to sue you later.
What's not to love?

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17. exGlaxoid on October 11, 2011 3:12 PM writes...

rcryan: "About a quarter of all deaths in the US are from cancer. So prima facie, 44% seems too high."

But not all deaths are caused by medically preventable causes. I don't think pharmacauticals will help for automobile accidents, lightning strikes, fires, homocides, etc. But cancer is one of the top medical causes of death, and as noted above, CV disease already has a number of treatments that work OK or better.

I agree that developing a drug for cancel is easier. Maybe drug companies should just claim that all clinical trials are for cancer and then just look for people that have cancer and are also coincidentally obese/diabetic/infected/etc as once the drug is approved, it can be used off label for other indications. That may be the way to solve the pipeline problems for pharma.

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18. milkshake on October 11, 2011 3:22 PM writes...

@exGlaxoid: terminal cancer patients (which is what you typically enroll in ph I and II) are definitely not obese.

And they typically have host of cancer-related and chemotherapy-related symptoms. So unless you are looking for hair growth-promoting, anti-nausea, weight-gain or erythropoietin-like effects, you are not likely to see anything thats useful for other indications. Not mentioning that using cancer patients as low-cost test subjects would be hugely unethical and would bring quite an outcry if such behavior was revealed.

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19. Anonymous on October 11, 2011 4:30 PM writes...

You don't have to look any further than the problems in big pharma to explain this increase. Cancer drugs are toxic period! However, people are dying and options are limited and so it's easier (for pharma co's) to jump on the oncology band wagon than developing a squeaky clean chronic drug for inflamation, diabetes etc. It's a quick win and helps the bottom line. Great for risk averse organizations that have been burned in the past. There is no longer any patience in big pharma drug discovery! They want a win now!

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20. Anon-2 on October 11, 2011 6:42 PM writes...

Milkshake - I am sure that exGlaxoid was being facetious.

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21. Nathan on October 13, 2011 7:30 AM writes...

All, be carefull how you are interpriting the "44%" from E&Y. This is the percentage of clinical trials aimed at cancer. Many of the above comments (and Derek's comments) seem to imply that this means that 44% of R&D dollars are going to oncology research. This isn't true. As many of the comments have noted, oncology trials are typically easier, smaller, and more well-defined than other indications. This means you get much more clinical "bang-for-your-buck".

Hap's estimate that 15% of R&D money goes to cancer seems perfectly consistant with 44% of the clinical pipeline being focused on cancer.

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22. Ajay Malik on October 31, 2011 6:19 PM writes...

44% is not surprising considering that patients and their insurance companies will (un)willingly pay 100K or more for new drugs. Which other disease has that kind of pricing structure. It is not about shorter trials or increased availability of targets, but about investment returns. Although, shorter trials and increased targets help.

The debate on drug pricing is not new. Look at this 2001 MDD article (http://pubs.acs.org/subscribe/archive/mdd/v04/i03/html/03zall.html)

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