Pillhead

the personal views of a doctor in industry

NIH to kick-start research into rare and neglected diseases

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“The National Institutes of Health is launching the first integrated, drug development pipeline to produce new treatments for rare and neglected diseases. The $24 million program jumpstarts a trans-NIH initiative called the Therapeutics for Rare and Neglected Diseases program, or TRND.” ( NIH Announces New Program to Develop Therapeutics for Rare and Neglected Diseases, NIH News)

 

Rare diseases are those that affect less than 200,000 Americans, and neglected ones are those that affect the global poor disproportionately.

 

The program will identify suitable compounds for research in these disease areas and NIH will take them through pre-clinical development themselves. If they manage to get one through that far then they will look for external partners to take the compound on to phase 1 trials in humans.

 

Why do they feel the need to step in? According to the NIH press release, “Private companies seldom pursue new therapies for these types of illnesses because of high costs and failure rates and the low likelihood of recovering investments or making a profit”. As acting Director Raynard S. Kington notes, “The federal government may be the only institution that can take the financial risks needed to jumpstart the development of treatments for these diseases, and NIH clearly has the scientific capability to do the work.”

 

This is good news. Governments have a duty to to use some of our tax dollars to look after the less fortunate members of society. Some commenters are missing this point. The WSJ health blog for example: “It’s tough to get drug companies to work hard on drugs for diseases that are either rare altogether or common only in parts of the world where people can’t afford to pay much for treatment” (NIH Treads Where Drug Industry Rarely Goes). The point is that the pharmaceutical industry has no duty to be in unprofitable areas, and if it does venture there then it should be recognized for what it is: philanthropy.

 

Written by Pillhead

May 22, 2009 at 1:49 pm

Pfizer offers free drugs to retrenched Americans

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What a good story (Free Lipitor, Viagra, 70 other drugs for jobless, and Pfizer Launches Free Medicines Program For Newly Unemployed Americans). 

By offering to cover the cost of some of their current Pfizer drugs for up to 12 months, this program does three things: 1) takes some financial worry from the shoulders of these people, 2) keeps them on Pfizer’s drugs when they would otherwise be quite likely to either switch to a cheaper version or stop therapy altogether, and 3) increases the chances that those that benefit from the scheme will stay on Pfizer meds when they get a new job.

This is the holy trinity of recession marketing goods: good PR, goodwill, and good business sense.

We also know the name of the chap behind the idea: Dr Jorge Puente, a medical man.

Written by Pillhead

May 17, 2009 at 1:11 pm

Disease Management Programs

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I like to eat burgers. If I chose to eat a salad for lunch tomorrow instead of a burger, but then eat whatever I like thereafter, have I improved my health in the long term? Can the benefit of that one salad be quantified? What if I double my salad habit, taking one more salad the next day for lunch?

 

Like my appetite for lettuce, in the real world people do not take their chronic meds for very long either. So what good do these drugs really do if a patient takes them for only 3 to 6 months?

 

An article in the FT (The line from peddling pills to “disease management”) discusses the attempts being made to improve patient care and drug compliance using approaches outside of the traditional Dr-patient relationship. These strategies aim to address real problems: neither do patients take their medications as directed for long enough, nor do they curb their unhealthy lifestyles enough. The assumption is either that Drs are not inclined to provide this kind of support, or that they do not have the time. The solutions being looked at involve communicating with patients between their visits to the Dr. These may include reminders to take meds or advice on exercise and eating better. The hypothesis is that these interventions will improve drug compliance and have a positive effect on patient outcomes, ie patients will live longer healthier lives. By avoiding the expenses incurred by ill health, there may be financial benefits too for whoever would have been billed for them.

 

If we generously assume that these programs can double average compliance from 3 to 6 months, then for a 50 year old patient who will suffer an MI on his 65th birthday, this improved compliance would mean taking his medication for 3.3% of those 15 years, rather than an unassisted 1.6%. Intuitively, this does not look like a particularly impressive result.

 

I am a fanatical believer in drugs. But I know that even I am not very good at taking them. If we really want to shift the needle on our life expectancy then we will have to do more than take a statin for 3 months. It pains me to admit it, but we may need a more holistic approach.

 

Written by Pillhead

May 15, 2009 at 6:28 am

Scientists, MBAs, or Lawyers – who should run pharma?

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There has been much interest in an article in this week’s FT (Pharmas lack science expertise at the top) which notes that there will soon be only one big pharma company run by a scientist, John Lechleiter at Eli Lilly. For the record, I define myself as a scientist too and so I would also include Daniel Vasella at Novartis as he trained as a doctor.

Derek Lowe has a reasoned piece (Should a Scientist Run Your Drug Company?, Seeking Alpha) which states that there is possibly little overlap between science and management skills. This is fair, after all how likely is it that a person be simultaneously blessed with being a scientist and a leader? 

But I would say that part of the cause of our troubles, both in terms of reputation and pipeline, is that scientific principle has been diluted.

A good scientist speaks in short succinct sentences, never using two words when one will do. People do not trust those who add too much ornament to their speech. And it would appear that people also do not trust those that turn nouns into verbs and vice versa (actioning key learnings is a no-no).  Allowing a scientist to cast an eye over your CEO’s speeches might be the quickest way to improve public credibility.

The real reason why scientists are the key to pharma’s future relates to risk. A big firm has considerable, and perverse, internal incentives to minimize risk. People trained in management have little to fight these with. A scientist has something much more potent to hold onto: the hunger to abide by scientific principle. In our sometimes naive desire to ask, and try to answer, difficult questions we represent the only real antidote to risk aversion.

Perhaps scientists do not need to run the industry. But if pharma is to thrive, then it must start dancing to our tune.

Written by Pillhead

April 9, 2009 at 3:48 pm

Salvation through Innovation

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One of the funniest things that I read last year was Ranbaxy’s CEO lamenting the lack of innovation in big pharma. The writer was unremarkable and did not see the joke at all. Sadly, there are many examples of articles about our industry which reveal a very superficial idea about what makes us tick.

An example that recently caught my eye added to the line of nonsense about innovation (Innovation Is the Pharmaceutical Industry’s Only Salvation, The InVivo Blog). If the “salvation” that was referred to had been about evil within big pharma, but that the Lord will forgive us if we just invent a couple more good drugs, then it would have been interestingly novel. Sadly, the piece was about the god of Mammon and consisted the sharing of thoughts from Mr Jay Markowitz, a biotech analyst.

After noting, believably, that “44% of Americans had an unfavourable view of the pharmaceutical industry”, the article veered rapidly off-piste proposing that, “the industry’s woes boil down to a single cause: inadequate innovation”. As a good friend of mine would say, this guy must be smoking the weed! Might not the BILLIONS of dollars in fines we keep paying for improper marketing practices have something to do with our reputation?

The author got himself further into trouble looking at our poor productivity: in spite of the inconvenient fact that the number of new drugs registered by the FDA last year was the highest since 2004, he noted that we need more than a “meagre” 24 new drugs to fill the patent hole.

People think of “the patent hole” as the result of some fundamental failure to innovate in our industry. This is nonsense.

The patent hole is a direct result of pharma management not doing their job very well. No company can generate the steady flow of blockbusters which are required to support a business that is overly dependant on a single big drug – or handful of them. The reason for this is simple probability. We do not know how to make one, and we do not know which of our drugs will become blockbusters even after we launch them. Sometimes we get lucky and a drug does better than expected. Sometimes a drug that was expected to do well does badly. Add to this randomness the fact that big firms tend to lose the ability to take risks appropriately, and you can see why it is unlikely that the big firms will generate a steady stream of blockbuster drugs. Management’s sin is that it fails to recognise this simple truth, and it fails to plan accordingly.

Like many people, the author confuses the few big pharma companies that he deals in with the drug industry as a whole. He confuses the need for the biggest of big pharma to produce bigger pipelines (to improve their chances of netting a big drug for themselves), with the reality that the industry as a whole is doing just fine. Innovation is apparently quite strong still, and record numbers of drugs are being registered. The question does remain, however, whether these drugs will generate the same sales as the biggest drugs today. Time will tell. There is also a real possibility that the biggest drugs among the 24 newly registered ones may not belong to today’s big players.

This analyst has failed to grasp the simple point that we do not make blockbusters, we make drugs, and if we are lucky some of them turn into billion dollar drugs.

Written by Pillhead

March 31, 2009 at 4:16 pm

Posted in Pipeline

Tagged with , ,

Big Pharma Photographs Angry Harvard Medical Students

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By now, we have all seen the picture of the handsome Pfizer sales rep taking a photo with his camera phone (Do you know this Pfizer guy?, PharmaGossip)outside the magnificent facade of Harvard Medical School. Senator Grassley has fanned the flames (Senator Asks Pfizer About Harvard Payments, NYT)and in a letter to Pfizer wrote that he was “greatly disturbed” and he wants to see the photos. The ruckus is because the target of the pictures was a group of Harvard students protesting for their school to be more independent of industry support. While recognising that I am risking being called a contrarian, I do find myself asking: so what?

The students clearly did not feel intimidated by the cameraman. They continued their protest, and later openly spoke to journalists about him. For his part, the rep was happy to identify himself to the students.

In the fallout, the Pfizer spokesman adopted his customary position. While failing to say “thank you, Sir” afterwards, he did mutter something about the pictures being for a private collection.

Perhaps I am too English, but really; mountains and molehills anyone?

Written by Pillhead

March 9, 2009 at 12:21 pm

Posted in integrity

Tagged with , ,

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.

Written by Pillhead

February 23, 2009 at 1:22 pm