Thursday, July 23, 2015

Publishing medical trials

This week's edition of The Economist has a couple of pieces on the need to make sure that all medical trials are published. The campaign by AllTrials in the UK has made great inroads on this issue already but now investors are signing up because they realise that lost data could be affecting the way they value companies. The first piece is a leader (op-ed).


Drug testing

Trials and errors

The evidence base for new medicines is flawed. Time to fix it

Jul 25th 2015 | From the print edition

WHEN patients are prescribed a drug, they might assume it had been subject to the closest scrutiny. They would be wrong. The results of about half of all clinical trials are never published. Companies are allowed to run many tests and publish only the ones with results they like. Unsurprisingly, negative results are far less likely to appear in public.

Regulators can see the results of every trial. But that provides only so much comfort. Officials may well be convinced that a particular drug has enough value for a few patients to pass the bar for approval, but that does not tell doctors whether the drug is better to prescribe than other treatments. And the regulators have limited resources. They cannot match the sort of scrutiny that comes from making all trial results public. Independent evaluations were important in raising concerns about the heart-attack risks associated with Vioxx, a painkiller that was recalled in 2004.

At best, this bias in published results has produced a polluted evidence base. Patients have been prescribed antidepressants that look much less effective when unpublished data are taken into account. The British government’s decision to stockpile antiviral drugs in case of a flu pandemic looks less clever now that previously unpublished data have called their efficacy into question. At worst, the skew has caused demonstrable harm. Some patients may have died because data about potentially dangerous side-effects were not published; volunteers in clinical trials may have suffered harm for no reason.




Clinical trials

Spilling the beans


Failure to publish the results of all clinical trials is skewing medical science

Jul 25th 2015 | From the print edition
I’M THE one who looks the patient in the eye and tells them the trial is beneficial,” says Tim Crater, a research physician at the Hutchinson Clinic in Kansas. Dr Crater runs drug tests for large pharmaceutical firms. He says volunteers are interested in more than just the promise of payment. “A lot of people want to help, they are altruistic to a certain degree and want to advance science.” Dr Crater’s experience is typical. Those who participate in trials often believe that they are, in a small way, contributing to the advancement of medicine and that any suffering on their part will help others.

Unfortunately, this is not always the case. Though pertinent trials carried out by companies do have to be reported to those responsible for licensing drugs and medical devices, there is no obligation on firms to make them public. That means such trials cannot be scrutinised by outsiders. The licensing authorities look at them, of course, so anything approved should, in theory, be safe, and have at least some beneficial effect. But the practitioners who go on to use them do not know all the details.

Some estimates suggest the results of half of clinical trials are never published. These missing data have, over several decades, systematically distorted perceptions of the efficacy of drugs, devices and even surgical procedures. And that misperception has sometimes harmed patients.


Saturday, June 27, 2015

Now seriously... in praise of Connie St Louis

In the past few days an esteemed journalist and teacher I know called Connie St Louis has come under sustained attack for reporting what happened at a meeting she attended. She was by no means the only journalist at the meeting who heard the sexist remarks of Sir Tim Hunt, but she is now in the cross hairs for reporting what she heard and saw.

Of the many things that happened subsequently, one was that Sir Tim resigned from his position at UCL, an honorary unpaid position. Yesterday UCL issued a statement explaining their decision to accept and why it was necessary for Sir Tim's resignation to be accepted even if the remarks were meant lightly:

"..Equality and Diversity is not just an aspiration at UCL but informs our everyday thinking and our actions. It was for this very reason that Sir Tim’s remarks struck such a discordant note.....An honorary appointment is meant to bring honour both to the person and to the University. Sir Tim has apologised for his remarks, and in no way do they diminish his reputation as a scientist."

Sir Tim has also rightly apologised to the Korean women scientists who he offended. One might think that this would be the end of it. But no. The Times (London) has already made one attempt to discredit the original report by citing a non-verbatim report that seemed to contradict the original reporting (it didn't). Then the Daily Mail tried the same sort of trick again, but that didn't work. 

Now the Daily Mail is trying a more direct approach, hatchet job on Connie. Make no mistake, the Mail has decided to destroy her reputation, even though she was doing nothing more than her job. She did not orchestrate the Twitter monstering of Sir Tim. It is completely untruthful to say that Connie hounded Sir Tim out of his job. 

On the upside, The Mail seems to have got its knickers in a twist over something easily understood. which is that her university uploaded an outdated CV into its information system when they were running a pilot. None of this has any bearing on the fact that a Nobel winning scientist put his foot in his mouth. 

Connie has the strongest moral fibre of any journalist I know. I worked with her as Chair of the Association of British Science Writers, and I was thrilled that she took over, and then was elected, to head the organisation after I stood down.  She was an excellent leader, and garnered great respect for her work at that organisation.  She is kind, overly generous with her time and a truly great lecturer and teacher. City is lucky to have her on staff. 

Over the years, I've been a bit cynical about science journalism degrees. I used to wonder if academic courses were truly necessary to teach young journalists. I was proved wrong by Connie, particularly as technology has advanced so rapidly, her skills as a leader, journalist and human being have convinced me that she has something really important to teach the science journalism students of tomorrow. Now, more than ever, she has a critical message. It is this: speaking the truth to authority is a hard. It is also a hard and personally difficult journey for any journalist. 






Thursday, June 25, 2015

A media strategy for Tim Hunt....

For a while, oh maybe a day or two, I actually felt a little sorry for the scientist Tim Hunt. He was eviscerated in a classic but actually hilarious Twitter reaction to his offensive remarks about women scientists. Here is the thing, if they were not a joke then the Twitter reaction was surely fine. But if they were a joke, then why can't Twitter joke back?

Even if his remarks were off the cuff, a joke or honest... or whatever other line we have been fed, being offensive is offensive--even if you hoped it might be funny. Many of us have been there, the solution to a bad joke is pretty obvious when you think about it.

Imagine for a second the remarks were about race instead of gender and began with a line saying how odd it is for a racist to be invited to a talk make some remarks to black scientists. He might think it was funny. But that wouldn't make it so.

Dr Hunt's job was simple, he was invited as a Nobel scientist to give a talk give some off the cuff remarks to Korean women scientists. That presumably means saying something about how great a career science is, that how although it can present challenges for women who may struggle to maintain an unbroken publication record, that they have to keep pushing because they have so much to offer e.g Doudna & Sharpentier.

Instead it was Fail. Fail. Fail. The only thing to do in the face of being called out on this is to apologise straight away for being such a twit and move on. On no accounts should one give a half-hearted apology, be amazed that the furore continues, and then give whinging interviews about how bad YOUR life is.

Anyway now the Science Empire (no names no pack drill) has circled the wagons and decided to defend Dr Hunt, and now we have to put up with the embarrassment of The Times making another strike for the Science Empire, in the form of a leaked Euro "report" that says it was a joke all along. (Cue calls for reinstatement).

You know what I think? I think this is all nonsense and the idea that it was somehow reported wrong from a conference of science journalists would be laughable if it wasn't so serious. So, in a bid to end the hoopla, free of charge, here is my five point media plan for Tim Hunt.

THE TIM HUNT MEDIA STRATEGY

1. make a sincere statement of regret about his comments, acknowledge they are divisive whether or not they were a joke.

2. If asked whether they were honest or a joke come up with some sort of consistent and logical explanation*. (E.g. How about he says he was being honest about the fact that he is a chauvanist and that he was trying to see the light-hearted side of this, and he now sees that this wasn't helpful and actually pretty dumb. That might explain being honest and joking at the same time. But either way, refer to point 1.)

3. Shut up

4. Oh, before shutting up, he should ask his friends in the Science Empire, such as Darth Dawkins Vader to shut up as well because the are doing him no favours and just making things worse.

5. That is it. (Refer to point 3.) **

It will all blow over in a month or three and you'll be able to go back on all those committees again as if nothing happened. Key point though, refer to no 1. And if anyone asks you about that event in Korea, refer to no 1 again. All a mistake, terribly sorry. Do not be tempted to revise or downgrade the apology, by claiming you were misquoted, just accept no 1 as the new reality because the remarks were stupid in the first place whether or not you think your stupidity was fairly reported.


* Handy pro media tip: think about this carefully before you open your mouth. Try it out on a few friends first for internal consistency and maybe in front of the mirror.

** Handy pro media tip #2: summarise these points on a piece of card and keep it handy. Front of flash card: Apologise. Back of flash card: Shut up.

Monday, June 15, 2015

Price of drugs

Pharmaceutical pricing

Crippling

Jun 4th 2015, 15:09 BY N.L. | CHICAGO

THIS week health insurers have begun revealing proposed rate increases to their health-care plans for 2016. These potential hikes, which in some cases exceed 30%, can be partly explained by the fact that insurers low-balled their prices in the early days of the Affordable Care Act in order to gain market share. But there is another reason: higher drug prices. Prescription drug spending increased 13.1% in 2015.

This rise is partly explained by some new drugs for Hepatitis C. More trouble is on the horizon. At the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago this week, scientists announced that new immuno-oncology drugs work in a wider range of cancers, and even better when given in combination. The problem is that these drugs are some of the most expensive the country has ever seen.

“These drugs cost too much,” said Leonard Salz, an oncologist at Memorial Sloan Kettering Cancer Centre, in a high-profile speech at the meeting. At $295,000 a year, the price of combination therapy is unsustainable, he explained. At a big drug-sponsored conference, this was like swearing at a vicar's tea party. The fact that the bad news about prices somewhat eclipsed the good news on cancer treatment was an irony lost on no one. And the problem of drug costs is expected to only get worse as Americans get older and fatter and the rates of cancer go up.  [More...]

Friday, June 12, 2015

What it means to be a scientist: male

The Science Advisory Board, an international network of science and medical experts, has just published the results of a study on global science that sheds some interesting light on what it means to be a woman in science--particularly in the light of the #distractinglysexy debate. 

With the caveat that that I have not dived deeply into the survey methodology, SAB report that female scientists in their survey are more likely to be dissatisfied with salary/benefits, job availability, gender barriers, and how they feel valued as scientists than their male colleagues. The study was part of a Global Science survey that sought feedback from people about why they became scientists and what it is like to be a scientific professional. 

 “We originally set out to look at what it means to be a scientist,” said Quentin Kreilmann, Science Advisory Board Community Manager. “We found two narratives depending on gender, one of which comes with additional challenges.” The Global Science 2015 survey sample includes 1,478 respondents, 58% men and 42% women, from North America, Europe, Asia, and South America. 

The study results showed that some women see gender as a barrier to pursuing a career in science, whereas men did not. When asked, “based on your experience, what do you perceive to be the biggest barrier to pursuing a career in STEM,”15% of female respondents selected gender, compared with only 2% for their male counterparts. Women also report gender inequality after attaining scientific positions.

SAB is working on getting the report put online. In the meantime I have taken screenshots of the most interesting graphics. 











Sunday, June 07, 2015

A Canadian wind...

When it is cold in Chicago it usually means we are getting a stiff breeze from Canada. When it comes in over the city and hits warm air from the skyscrapers little clouds form over the city centre swirling around over the tops of the tallest towers.

These timelapses were taken yesterday. The camera is at a point west of downtown looking east.

video



Sunset.

video


@natashaloder

Friday, June 05, 2015

More on the care and feeding of journalists

OK so this is the second part of a two part item on the Care and Feeding of Journalists. Although, let's face it, this is just about feeding this journalist in particular. Although I think some of the guidance is useful for many of the people I work with at The Economist.

FAQs

What is the best way to reach you?
Email, which is my first name and second name as one word then an "@" economist.com. You can also follow me on Twitter @natashaloder, and try to catch me there. When I'm checking Twitter, I'm open to being engaged in chitchat.

Can we send you anything?
It would be great if you could exert a bit of control over what you send, it may be just a press release for you but with all the junk I get sent it is death by a thousand cuts. A previous post lists the sorts of things I am interested in. (When I start getting particularly irrelevant pitches, I have resorted to using the #spamPR hashtag to highlight the worst offenders.)

If you really must send press releases about things that we both know are of no interest, please us both a favour and don't follow up.

If you think that it might be of interest, please feel free to send a second email reminding me about the first one.

Can I get feedback on what you thought of the release?
No. Seriously. Too busy. It will either get deleted or filed if I think it might be useful later.

And if you call me to re-pitch me a press release when I'm busy please don't expect me to be delighted to hear from you. And if you say "do you have a minute right now?" that is going to make me cross because we both know it is going to take longer than this. Also you have started your pitch with something we both know is a lie... which really doesn't help your case.

I would say that one or two in ten of the people who reach me on the phone actually have something to discuss with me that I want to hear. This is a really poor hit ratio so if you are calling you need to know that I'm expecting the call is going to be a complete waste of time before I've even picked up the receiver. When we speak, be prepared to answer questions such as, "what kind of article do you imagine I might write about this?" And, "have you ever read a piece like this in The Economist?", or "how does this technology work?".

How often do you write stories based on press releases?
Not often, truth be told.

Will you send me a reply to my email?
Sometimes. If a personal pitch is made to me (not just a mass email release), and I think it has a pretty good sense of what I'm interested in, I will try and say thanks but no thanks. If it is something I might pick up on at a later date, I will try and reply.

What do you look for in a story?
See my previous post. Bear in mind that in the age of the internet, as a journalist I really do need something new and different to say. Also, you know there really are only so many articles that I can write about the scourge of antibiotic resistance or mobile digital health.

When should I contact you?
It depends on what you have. My busiest days are Mondays and Tuesdays. That said, if it is late news for that week then these days are fine. If you are wondering what the best day to send something that isn't exactly news but which you would like to read, I would suggest Thursday or Friday. If you have a story that is going to need a lot of legwork, your 1,000 page annual review of the drug industry, you should send me a note a few weeks before it is going to hit.

What are your deadlines?
This varies according to the article concerned.

Can you send me a list of questions?
If you requested the interview, NO. You already emailed me to tell me what you wanted to talk about and I said yes. Seriously total time suck all round.

If I requested it I will give you an idea of what I want to talk about. Again list of questions is total time suck, and could well have changed depending on who I've spoken to prior.



Top tips 

* Try and keep pitches focused to my main thematic areas. Business stories on health (and pharma), and medical science and technology. See previous post.

* If I do agree to speak to your executive on the phone, please do not email to ask when the story is going to come out. That just shows that you don't understand how this works.

* I detest voicemail.

* Please don't use email tracking. It is impolite. All you need to know is that I do my job by reading my email as regularly as I am able.