Pillhead

the personal views of a doctor in industry

Archive for February 2009

Sales of New Drugs – no more blockbusters?

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An article in Forbes (The Value Of New Drugs Is Dropping) cast an eye over the initial sales of new drugs launched in the last decade. The article looked at data from IMS, and found that drugs launched in 2008 sold only a tenth as much in their first 6 months on the market as did drugs launched in the banner year of 1999. Despite the good news that the FDA approved more drugs in 2008 than in 2007, “new medicines contributed much less than 0.5% to the growth of the global market, another way in which the first half of 2008 constituted six of the weakest months in a decade”

At first sight, this article appears to fit our gut feeling that the “low hanging fruit” are taken and few blockbuster drugs remain. It also fits and confirms the results of the drive espoused by several firms for more drugs of middle revenue.

But looking at the way this article presents data looks a little like cherry picking to me. The period of study is 1998 to 2008, but one of the big comparisons is made with 1999 a “banner year”. And using “six” as a statistical cutoff is odd: “2008 constituted six of the weakest months in a decade”?

How bad is it really looking for us from this data?

first 6 month sales for new drugs

first 6 month sales for new drugs

If there is a trend here, and I do not see a clear one, then it is equally valid to say that the last three years have seen a return to form. Never since the hayday of the late 90’s, when pharma launched Singulair, Vioxx, Viagra and Avandia, have we seen sales at these levels. 

I do not think this would be an accurate refection, but it is important not to see what we want to see in the data. 

What I do see in the graph is a remarkably stable picture of first 6 month sales in the region of 5-10 million USD. It would be interesting to look deeper to see why. 

There is certainly no strong indication here that the drugs launched more recently are any different from those 10 years ago. For that conclusion, we need more data.

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Written by Pillhead

February 23, 2009 at 1:22 pm

Access to Medicines – Andrew Witty at GSK sets the pace

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In a speech at the Harvard Medical School last week, Andrew Witty, CEO of GSK, set out a bold new agenda for increasing access to medicines in poor countries (PharmaTimes, GSK lays out plans to seriously tackle disease in developing world). It was a triumph of substance over style in which GSK identified 4 key steps that it would be taking, and encouraged other firms to join it.

1) A more flexible approach to IP. A patent pool for medicines for neglected tropical diseases including both small molecule and process patents.

2) Pricing discounts for the poorest countries. GSK will charge no more than 25% of the full price as long as this covers cost of goods.

3) Greater collaboration. GSK already has a dedicated research centre set up in Spain and offered joint ownership to other institutions that want to join the 100 scientists already there.

4) Partnership in delivering solutions in the poorest countries. GSK commited to ploughing 20% of any profits made in these poor countries back into local health infrastructure projects.

The pooling of patents is a trick that has a history in industry: an article in Bloomberg (Glaxo’s WItty to Share Research to Aid Poor Nations) notes that industrial cooperation of this sort was used in 1917 to speed the manufacture of warplanes during WWI, but this will be a first for the pharma industry.

Understandably, some are finding this all too progressive to believe (PharmaGossip, Arise Sir Andrew Witty (or is it Saint Andrew?)). Some have noted that this bold plan will not necessarily cost GSK much money as it only made about $43 million in these countries last year (FiercePharma), but to be fair to GSK, Witty said as much: “We’re not putting enormous amounts of money on the table here,” he noted at Harvard.

Rarely does a pharma executive speak with such clarity of purpose, and rarely does a pharma executive accept that he does not have a commercial obligation to try to make money from the poorest countries directly. Bravo Mr Witty on both counts.

Written by Pillhead

February 19, 2009 at 2:11 pm

Sales Reps – Pharma’s Lost Assets

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A new survey by SK&A (Physician Access Survey) makes sober reading. Remarkable in its coverage, according to  IN VIVO (Don’t Come Knokin’ On My Door) nearly all active practising physicians in the US were surveyed with a response rate of 94%, the results show that 24% of all physicians in the US now refuse to see sales reps at all. The numbers are particularly bad in large practices and hospital linked clinics; worryingly, the situation is getting worse.

Why does anyone chose not to meet with a sales person? Speaking for myself there are three common reasons: a) I do not want to listen to the person, b) I am not interested in what the person is selling, or c) I am already using the product

In terms of pharma sales, I think the first reason is where the interesting discussion lies.

Of all the relationships in healthcare, the one in which trust is most central is the Dr-Patient relationship. Drs really cannot afford to lose the trust of their patients. Unfortunately the public does not hold the pharma industry as paragons of integrity, and as a result sales reps are being banned from clinics. Drs have found themselves too closely and too publicly tied to us. They are attempting to reclaim the moral high ground following a spate of scandals involving Drs accepting large amounts of money and perks from the pharma industry; the last thing a Dr wants is to be too closely associated with our negative reputation.

But why is this changing now? The codes of conduct which our industry follows are getting ever tighter. In the US we are not even allowed to give pens away anymore (unless they are educational in nature!). Things that went on in the past would not be dreamed of today; and if they do happen then we are exposed to fairly significant legal consequences.

Some say that reps in the old days were better trained than today and in those days they were invaluable partners. Perhaps. But possibly Drs used to put up with us because they benefited considerably from the perks of the relationship. Those perks have now gone. Coupled to this is a new call for transparency which is being embraced by the healthcare industry as never before. At a time when we are trying to clean up our act, Drs are also trying to clean up theirs.

Our mistake is in making it too easy to lock us out. When Drs balance the positive and negative effects we have on their work, the balance is coming out as negative in more and more cases. We are not needed because we add too little value today.

The relationship needs to be redefined. The focus must be on integrity first and then on finding a way to be useful to our customers.

Written by Pillhead

February 15, 2009 at 3:10 pm

Posted in Sales Reps

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Blockbuster Drugs and Innovation

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Sir James Black is a nobel prize winner for medicine and inventor of both propranolol (at ICI) and cimetidine (at Smith Kline and French). In an era when entire R&D divisions of big pharmaceutical firms have trouble coming up with a single drug of this caliber, a man credited with two of them must be taken seriously.

In a fascinating interview with the FT (An acute talent for innovation), he noted that we are an industry with “a reputation for development” but that “it keeps making promises”. I found this rather revealing in an elegantly understated way.

Our reputation for discovery is a deserved one. It talks to our past where significant headway was made against significant diseases. The interesting part is that Sir James feels that today we keep making promises that we do not keep. He is, in part, talking about the inflated sales projections for some of our pipeline products.

To emphasize just how off base our predictions can be, Sir James points out that the sales forecasts for propranolol and cimetidine (£250,000 and £5m respectively) were actually off by orders of magnitude. I know of another drug that was off by three orders of magnitude. Clearly even when we have a drug ready for market, even when it is in fact of the caliber to be a blockbuster, industry can be fairly clueless.

According to Steven Paul, President at Lilly Research Laboratories (WSJ, Big Pharma R&D: Things Are Tough All Over), only one in eight drugs in phase II trials will make it to market. It does not need pointing out that making it to market is no guarantee of commercial success. The idea of prospectively making bold predictions based on such unlikely bets is odd, both in the sense that otherwise intelligent people make them, but more so perhaps that nobody notes that this is daft.

As Sir James notes, “very few of the drugs classified as blockbusters retrospectively were designed in that way.”

Written by Pillhead

February 15, 2009 at 7:12 am

Posted in Pipeline

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Science Education, East vs West

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I have an unexamined belief that I am a good product from the best educational system in the world. I was educated in the West, specifically in England, and I confess to being a UK education snob seeing the Western system as the best way to prepare a person to solve problems at work, and to be creative. My view is largely supported by personal experience and anecdotal stories (see American Creativity vs. Chinese Skills in Education Week – boy those educationalists can really discuss an issue!)

It was refreshing, therefore, to get cold water poured over my preconceptions in a paper by Lei Bao in the Jan 2009 issue of Science (Learning and Scientific Reasoning). The study tested nearly 6000 freshmen about to commence a physics degree in China or USA to see whose education system was better at preparing them up to this point.

The Chinese system is rigourous and knowledge focussed, while the US system is broader and less focussed on the acquisition of knowledge. Which students would perform better on tests of physics knowledge and problem solving skills?

The results, in graphs below, we striking. The Chinese students trounced the Americans in terms of knowledge (eg 66% vs 27% on the Brief Electricity and Magnetism Assessment, as Bao noted the Americans scored little better than expected by chance). However, the problem solving results were almost identical (the graphs are almost superimposed below).

results graphs

results graphs

The paper alone is fascinating enough, but the most remarkable thing is the way in which so many commentators are so quickly using the results to support wildly different opinions:

“Our study shows that, contrary to what many people would expect, even when students are rigorously taught the facts, they don’t necessarily develop the reasoning skills they need to succeed” – author, Lei Bao, in Ohio State U Research Communications

“… modern science education (at least in the UK) focuses too much on the knowledge and too little on the method” – Ed Yong at Not Exactly Rocket Science

“… this finding might actually apply to evolutionary studies. Maybe just teaching fact, Fact, FACT! isn’t necessarily the best thing for science students” – Thinking Christian

People will always use scientific evidence to support a variety of positions. But the more selfish perspectives should be kept on the fringe. In this case, the centre is being drowned out by the egos of the ones reviewing the data. It has gone almost unnoticed that deep within his commentry, Bao states that, “We need to think of a new strategy, perhaps one that blends the best of both worlds”.

If one removes oneself from the systems under review here, and our assumptions already built around these systems, what conclusion would one draw from the results? The results show that the American and Chinese systems both similarly prepare students with problem solving skills, but that the Chinese students also get a truck-load of knowledge at the same time, which the American students do not. On the basis of this paper, the Chinese system is superior.

So, why is this not discussed at all, by anyone? 

I believe the answer is not savoury. I believe that it goes to our prejudices in favour of what we feel comfortable with because it is what we grew up with. It is not scientific, and goes against the scientific method that we hold dear.

The reason we do not champion the Chinese system comes from outside the paper itself. It is captured in a comment made by one of the co-authors, Jing Han, who says, “To do my own research, I need to be able to plan what I’m going to investigate and how to do it. I can’t just ask my professor or look up the answer in a book”. This is the sort of thing that the net is full of in discussion threads on the subject of Chinese vs American students. It is not pretty.

I think that if we get off our hobbyhorses then perhaps we will be able to move this discussion along a little. We should begin by defining more carefully what it is that we are looking for. If it is graduate students who can come up with their own topics for research then say so. But, I do not think that this is an important criteria for anything of any real importance, however annoying it is.

Perhaps we should leave the last word to Peng Guohui, principal of Jindao Middle School in Guangzhou, China, who was quoted in the Education Week article. He suggests that, “Knowledge acquisition is the basis for creativity …”

Written by Pillhead

February 8, 2009 at 4:48 am