The FDA states it’s happy to sanction unproven drugs

Debate continues to swirl about the cholesterol management guidelines issued by the American Heart Association and the American College of Cardiology recently. The new recommendations shift the emphasis away from treating those on the basis of their cholesterol levels to based on overall risk of cardiovascular disease.

How is risk determined? With ‘calculators’ that use data such as cholesterol, blood pressure, smoking history and body weight. What a shame, then, that these tools used to calculate risk have been found to be quite flawed, and generally appear to overestimate risk. This, coupled with the fact that the recommendation is to treat people at lower risk than previously, means that many more people stand to be treated with cholesterol-reducing drugs such as statins.

However, the new guidelines also recommend that drug treatment should essentially be confined to medications that have actually been proven to reduce the risk of cardiovascular events such as heart attacks and strokes. Overall, this does appear to be true for statins, though the reality is the evidence shows that, in individuals without a prior history of cardiovascular disease, many people need to be treated with one person to benefit in terms of protection from a heart attack or stroke (and no-one will have their life saved).

Nevertheless, I welcome the recommendation to base treatment on drugs that have been proven to have clinical benefit.

However, if doctors were to actually act on this advice today, then the bottom might fall out of the market for some drugs. One example is the cholesterol-reducer ezetimibe, which has never been shown to prevent a single heart attack or stroke. It might also apply to a new class of drugs known as the PCSK9 inhibitors. While these reduce cholesterol, there is no evidence that they have clinical benefit. You can read more about this issue on the Reuters website here.

The very next day, Reuters carried this story. Here, we are informed that the Food and Drug Administration (FDA) in the US has issued a statement informing us it may grant licences to drugs without them having been proved beneficial to health. Yes, in other words, the FDA continues to be happy to let drugs onto the market with no proven benefits whatsoever.

The timing of this statement is extraordinary, and it seems to me to have been released to sooth the nerves of pharmaceutical company executives who are perhaps worried they are not going to be able to peddle unproven medicines in the future. Makes me wonder who the FDA exists to protect.

6 Responses to The FDA states it’s happy to sanction unproven drugs

  1. Chris 6 December 2013 at 10:23 am #

    Something that really narks me is the reporting of ‘findings’ of research and studies issued to the media in press releases prior to being fully written up, prior to being submitted for peer review, and prior to having been published in a suitable journal.

    So we have newspapers and other media types reporting the promise of some new wonder drug, heralding its advantages, and no real discussion of the cause(s) of the medical conditions it is purported to treat, with no real process of examination of the facts actually taking place.

    One of the UKs familiar tabloid newspapers is always making front-page news of such ‘findings’ and in many cases the reporting is jumping the gun somewhat because the findings have undergone the full process of review or publication. Neither has the reaction of the (peer) community been taken into account. And the other give away is that the journalistic discussion is always revealing of bias, with far more attention given over to the promise of the ‘treatment’, little regard for how complications and side-effects may arise, and very little discussion or interest given over to gives rise to the health condition in the first place. Put plainly the lucrative solution is always championed over contemplation of, or interest in, the low input solution of addressing the cause.

    The Daily Mail tops my list of despised reporters and reporting, but a recent edition of New Scientist alarmed me for contributing to exactly the same process I described above. I did my homework and, yes, did establish, that the write up of the exercise had not been written up, peer reviewed, or published, and so it was impossible to check the validity of some of the claims the articles author, Jessica Griggs in this instance, declared in the copy. To my eyes this is not science but marketing, and such marketing amounts to fraud if it makes claims that cannot be readily verified or are not supported by evidence.

    In an email I asked the lead scientist for a citation: Precisely where in the literature can evidence be found that fats in the diet give rise to diabetes?, I enquired. Silence. Stony silence.

    The closer science gets to market, the less any semblance of scientific integrity is preserved.

  2. Chris 6 December 2013 at 10:48 am #

    “.. .. the findings havenot undergone … ..”


  3. Barbara Summer 6 December 2013 at 3:12 pm #

    Good Morning Dr.

    Yup, bought and sold here in America to the highest bidder.

    The bottom line is for people to become conscious but that would require effort.

    Nothing could happen to further their coffers if the masses became healthy and took the power back that they have relinquished.

    Best, Barbara Summer

  4. Bobby. dean 7 December 2013 at 5:54 am #

    Yet look at what interferance the FDA has done for people who are doing self directed health care… they’ve stopped the availability of 23andme!!

  5. Gregory Barton 7 December 2013 at 11:26 am #

    “Wall Street analysts also expect the PCSK9 inhibitors to generate annual sales in the billions of dollars.”

    Afterthought: “”The compound’s overall safety profile will also be factored into this decision,” the agency said.”

    … Reuters article, quoted above.

  6. Dan 7 January 2014 at 1:49 pm #

    The FDA is obviously in bed with big pharma.

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