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    Institute Of Cancer Research Criticizes Drug Companies For Not Testing On Children Enough
    By Hank Campbell | February 11th 2014 04:30 AM | 16 comments | Print | E-mail | Track Comments
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    In the endless war on pharmaceutical companies, there is a consistent refrain; the US Food and Drug Administration is too slow to approve new drugs unless it approved drugs too quickly and the product hurt someone. Mainstream media highlight the complaints of doctors and patients that some drug or another is available in Europe or Asia but not here and then on another page delights in a lawsuit about how evil the company was for making a drug which carried risks.

    Safety is important or it isn't and we often default to the precautionary principle which says it is. Thus it feels odd to have cancer experts in Europe criticizing drug companies because they don't rush to use untested pharmaceuticals on kids with cancer and enroll desperate families who lack the ability to make rational informed consent into a trial. These experts say drug companies are avoiding testing on kids and the EU is letting them get away with it. The same drug companies that are criticized for just throwing treatments at the public is now under fire for for denying kids "new, potentially life-saving drugs", says the Institute of Cancer Research, London.

    And they want changes made or else, they warn, evil corporations won't sell their expensive products to governments and insurance companies that deal with sick children.

    Wait, what?

    It's hard to defend pharmaceutical companies - until we consider the alternative. Currently drug discovery is one of the last areas of American research that isn't controlled by the government. It often takes a decade or more, it costs billions, it fails 95 percent of the time, it then takes years to get approved and, if it gets approved, companies have only a tiny window to sell it during which time they are called profiteers exploiting sick people, including by the government that puts new regulations and hurdles in place.

    Yet the alternative to drug companies is...the government. If politicians control drug research, each drug would cost $20 billion and take 30 years to complete and, if recent history holds, a new president who didn't like the old one would wipe out entire programs because they had a predecessor's name on them (President Clinton with the Superconducting Super Collider and President Obama with the Constellation program are two giant examples) and then they would start a new "Manhattan Project" For X with their own name attached to it.

    The Institute of Cancer Research instead wants to force companies to test their drugs on kids. Now, it reads ridiculous because it is, and I am not against kids in clinical trials, when it makes sense. Anyone who knows anything about the industry knows that by the time a product gets to a Phase III clinical trial the ethical and safety issues should be settled. These trials cost hundreds of millions of dollars, no company is wasting that kind of money frivolously unless they truly believe it works. But the perception among the the public is there are "approved" drugs and everything else. We've taught them to distrust medicine, the anti-vaccine and anti-medicine community says they are not anti-science, they are anti-corporation and we let them get away with it. So if the company does not want to test on kids, I think they should have a super vote.

    But they will err on the side of cautions because we have demonized drug companies to such an extent that they don't want to test anything that could get them in the newspapers. Most parents won't enroll their children in clinical trials, which means even drugs designed for kids have a hard time getting a large enough study. A parent who does enroll a child in a clinical trial even uses that term "guinea pig" about their child because they have been trained to self- excoriate for embracing new treatments. It's so against the grain that enrolling a child in a trial makes it into the Wall Street Journal.

    The Institute of Cancer Research not only wants exemptions for companies to not test on kids removed, they want to force them to test on kids. Their concern is that some new drugs may have pediatric uses even if they aren't indicated, but companies are unwilling to spend the money and take the risks to conduct the trials to find out; as evidence, they say 14 out of 28 recent cancer drug approvals (since 2007) might be used for kids. So they want the rules amended; currently a company doesn't have to test a drug on kids if the adult cancer targeted does not occur in children. It seems cut and dried if it doesn't occur in children, right? Not really, almost any genetic link to cancer can be found by someone somewhere to also have a potential genetic instance in a child also. 

    The EU offers longer exclusivity in return for Paediatric Investigation Plans that involve children and critics say they are not taking advantage of it. Imagine a for-profit company turning down the chance to sell its product at a profit for longer, if they would just agree to test on kids - they still don't want to do it.

    In reality, these are only potential instances where a certain drug may have a benefit in pediatric cases. The authors highlight drugs that treat cancers caused by mutations in the ALK or EGFR genes and say ALK and EGFR mutations have been implicated in some childhood cancers. Given that, they contend companies should be forced to stretch out approval for a really small population that has no indication it will be helped. 

    Professor Alan Ashworth, Chief Executive of The Institute of Cancer Research, London, wrote in their statement, "It's essential that ground-breaking cancer treatments are tested not only in adults but also in children, whenever the mechanism of action of the drug suggests they could be effective. That requires a change to EU rules, since the current system is failing to provide children with access to new treatments that could add years to their lives."


    Yes, drug companies are not being greedy enough. We need to force them to care more about the bottom line.

    Comments

    Holy hyperbolic and wrong-headed arguments, Batman! Exactly what studies 'prove' how much any given drug's R&D is going to cost if it's done by "the government"? Who underwrites basic research in the U.S. (upon which almost all pharma co. research is based)? The NIH, which is 'the government'. This article is chock-full pseudo-scientific window dressing slathered on a bed of unfounded Libertarian HURRR.

    Oh wait, I thought this was a legitimate science site. My apologies.

    Hank
    Well, none of your conspiracy tale is true, or NIH Director Thomas Insel would not sympathize with private sector research. The private sector gets very little from the government - but obviously the government gets a whole lot of money from drug companies.

    The comments on the article prove the point; anyone who notes the value of drug companies is called (a) a paid shill, which is not only not evidence-based, it is a blatant lie, or (b) pseudoscientific.

    In your case, you don't know what pseudoscientific means - and what libertarians have to do with it is beyond me. The Institute is saying companies should have to test on children, it is not libertarian to note they should not be forced to delay approval to test on small populations where the treatment is not indicated for it. It is common sense.

    This article is just one more thing bought and paid for by Big Pharma. Nice job sell out.

    I wish it were true that BIg Pharma paid people to support their views. I'd totally sign up for that. Unfortunately, that is just nut job conspiracy theory. Put a little extra aluminum foil on your head for me. You don't want Big Pharma reading your thoughts.

    Hank
    My car is 12 years old. If people knew how much money I had lost on this site the whole audience would want to slap me. So if I were a sell out, it means being a sell out pays pretty terrible.

    But that is the go-to response for any factoids that violate a world view. In this case, that corporations are all eeeeeevil, unless we want to force them to save more lives because they are awesome and only they can do it.
    Really dude? A conspiracy theory? Go to google and just type "fd." You need'nt even type the "a" before auto complete comes up with" FDA regulators drug companies revolving door" as the first suggestion. Once you click that, you will notice the long list of articles by real journalists about the corrupt interaction between the FDA and big pharma. Perhaps next time put your pompoms down for a minute and do enough background reading to produce an article that a fifth grader cant debunk in five minutes.

    Hank
    I can also Google UFOs, astrology and homeopathy and find a bunch of people claiming those are real. Googling is actually not science. This probably explains why you start every conversation by talking nonsense about how someone must be a sellout if they disagree with your crackpot world view. If you want to have an intelligent conversation, start off by not being a zealot inventing gibberish about people you have never met. 
    Maybe if your idea of journalism involved even modest fact checking rather than you opinion, or you actually dealt with science rather than you thread bare opinions about business, your car wouldn't be twelve years old. If you had ANY intellectual integrity, you would be addressing my points with facts not slander. The truth is you don't have the courage to face being dead wrong so you call names. Perhaps you should try writing children's books. In that realm, your obvious gift for making it up as you go along might actually make you successful.

    Here is what real journalists are saying, you know gibberish:

    http://www.forbes.com/sites/davidmaris/2012/10/10/fda-recall-points-to-s...
    http://www.scientificamerican.com/article/fda-let-drugs-approved-on-frau...
    http://digitaljournal.com/article/322761
    http://www.goodhealthinfo.net/cancer/fda_cozy_relationship.htm

    Hank
    I want you to show evidence that I have ever gotten any money from a drug company. That was your crackpot conspiracy theory. 

    If you want to contend Pres. Obama is catering to right-wing corporations, fine by me, some guy's blog on Forbes can give you confirmation bias, I want you to back up your claim that I take money from any pharmaceutical company.
    Sellout, you have completely changed my thinking. I think you are a paid mouthpiece for The Alternative Medicine Foundation. I normally wouldn't have made such an absurd conclusion, but your logic is so sound that I must also use it now. You want to talk about fraudulent data! You think 1 out of 100 drugs having fraudulent data is bad, how about pretty much an entire INDUSTRY? And you are a paid mouthpiece of them because I assert it and because you oppose big pharma - basically the same impenetrable logic that you use.

    The tine foil isnt to stop brain waves rather to keep you from getting all that kool aid youre drinking from ruining my hair. Maybe next time read a little more than a couple headlines before you comment perhaps then you will understand how dumb you sound.

    And don't forget that the billions they spend in research is mostly publicly-funded state college research money, paid for by the taxpayer. Oh, and that the drug companies spend 19 times more on marketing (on average) than they do on research.

    Sources:
    http://undsci.berkeley.edu/article/who_pays
    http://www.bmj.com/content/345/bmj.e4348

    Hank
    So you are saying drug companies are valueless and the government rules science. Then why force drug companies to test on kids if they produce no products anyway? It makes no sense to complain that "life-saving" drugs are not tested on children by corporations if government and academia does all of the discovery anyway. 

    You're contradicting yourself.
    "Oh, and that the drug companies spend 19 times more on marketing (on average) than they do on research"

    Is that right? So the pharmaceutical industry spent between $70 and $100 billion on R&D last year - therefore you are saying that they spent nearly $1.5-$2 trillion on marketing? Where did all this money come from. Oh yeah, I know. Right out of your butt.

    "Not really, almost genetic link to cancer can be found by someone somewhere to also have a potential genetic instance in a child also. "------What?

    Broader point is fully understood and you are correct. Though I have found that when companies do test drugs on kids they are "ethically" bound to not perform placebo control. Is there any value in a study without placebo?

    Hank
    It reads clunky but I am glad you were able to see where I was going - the ALK and EGFR mutations mentioned, for example, play a role in some childhood cancers so they want virtually anything involving those to be tested on kids, when the drug is not designed for childhood cancer. Then you add in all of the other links to cancer and almost no product escapes childhood testing, even if the researchers behind the product don't make it for kids and the cancer does not occur in kids. It will really stretch out the approval process with no defined benefit to patient.

    I don't have a problem with a higher ethical standard for children but understanding is also different in kids. Giving one child with a deadly cancer a placebo is creepy but for plenty of other studies, new therapy versus old versus nothing, kids are given placebos.