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An article in the german online newspaper Spiegel Online starts with the headline

90 Prozent aller neuen Medikamente taugen nichts (90 percent of new drugs are no good)

The article is a about a new report from the government-run insurance TK, the article states

Nicht einmal jedes zehnte 2010 neu zugelassene Medikament verbessert die Behandlung der Patienten. (Less than 1/10th of drugs approved in 2010 improve the treatment of patients)

The accusation is that most new drugs are just "commercial innovations" and don't provide a significant benefit over older and cheaper drugs.

Is this an accurate overview over the state of pharmaceutical innovations? Are such a large number of new drugs approved that provide no significant benefits to patients?

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    I imagine we will have to use some careful demonstrations of the word "useful". Many novel drugs cost more but offer little marginal health benefit over their predecessors. And many common drugs thought to be useful also have significant side effects that may negate their benefits in large scale use.
    – matt_black
    May 31, 2013 at 12:40
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    Yes, I agree with @matt_black that some definitions might need to be defined before answers can be formulated. For example, is the claim that 90% of the drugs are not effective or that 90% are no more effective than the ones that have gone off patent?
    – rjzii
    May 31, 2013 at 13:20
  • And this linked question is relevant: skeptics.stackexchange.com/questions/13719/…
    – matt_black
    May 31, 2013 at 13:43
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    Note that the study the number is from had a very small sample size (23), was paid for by an organization trying to reduce the money it spends on drugs, and there has already been a change of law in this area since the drugs in question were approved.
    – Michael Borgwardt
    May 31, 2013 at 15:35
  • They are definitely talking about drugs that are approved for use?
    – GEdgar
    Oct 19, 2015 at 20:54

2 Answers 2

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Some experts clearly believe that too many new drugs don't bring significantly advances to therapy

In an article in the BMJ in 2012, two experts reviewed the evidence about a perceived crisis in innovation in the pharmaceutical industry. They concluded that there was no crisis and the long term rate of new drug discoveries and introductions had been stable and was not in decline.

But, after reviewing approvals over a significant time period, they remarked (my emphasis):

More relevant than the absolute number of new drugs brought to the market is the number that represent a therapeutic advance. Although the pharmaceutical industry and its analysts measure innovation in terms of new molecular entities as a stand-in for therapeutically superior new medicines, most have provided only minor clinical advantages over existing treatments.

The preponderance of drugs without significant therapeutic gains dates all the way back to the “golden age” of innovation. Out of 218 drugs approved by the FDA from 1978 to 1989, only 34 (15.6%) were judged as important therapeutic gains. Covering a roughly similar time period (1974-94), the industry’s Barral report on all internationally marketed new drugs concluded that only 11% were therapeutically and pharmacologically innovative. Since the mid-1990s, independent reviews have also concluded that about 85-90% of all new drugs provide few or no clinical advantages for patients...

...This is the real innovation crisis: pharmaceutical research and development turns out mostly minor variations on existing drugs, and most new drugs are not superior on clinical measures.

Their paper contains many further references to the primary sources which I won't repeat here.

Their analysis for drug launches since the mid 1990s is consistent with the idea that 90% of drugs don't significantly improve on previous drugs within an existing category (e.g. statins or NOACs). This is at least approximately the claim in the original question.

NB Drugs are complicated things with no two drugs having exactly the same profile of therapeutic benefit and side effects. This creates a large grey area where better depends on how much weight you attach to each benefit and side effect. In many categories this creates a lot of scope for every drug firm's marketing department to claim that their drug is better. Independent experts prefer to count major indisputable therapeutic gains and ignore the minor squabbling about trivial differences (so drugs that treated ulcers were a major advance over surgery, but minor variations in the drugs from different firms were not significant gains).

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    @nomenagentis Drugs are complicated. They have different mixes of benefits and side-effects. This creates a large grey area where it may be impossible to clearly define improvement. For example, does a slightly better performance combined with worse side effects count as better? When the differences are small improvement is a matter of opinion; it isn't a simple as a binary comparison.
    – matt_black
    Oct 19, 2015 at 18:42
  • I'll edit it to clarify.
    – matt_black
    Oct 19, 2015 at 18:46
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    Drugs also work differently on different people; if an existing drug offers benefit to 75% of patients and no benefit to 25%, and a more expensive drug with worse side effects offers benefit to only 50%, the new drug may be useless or it may be very useful, depending upon whether it only works on people whom the first drug would have helped anyway, or if it also works on many of the people for whom the first drug was ineffective. I'm unaware of many trials focusing on such correlations, however.
    – supercat
    Jan 18, 2016 at 21:05
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Partly yes referring to independent expert review in the points listed below.

  1. Eight percent of 946 new products in the review period 2002 to 2011 were clinically superior, down from 11 to 15 percent in previous decades referring to Donald W. Light in 2014.

In a recent decade, between 2002 and 2011, independent reviews by clinical expert teams in France, Canada, and the Netherlands have concluded that only 8 percent of 946 new products were clinically superior, down from 11 to 15 percent in previous decades. Only 2 were breakthroughs and another 13 represented a real therapeutic advance.

  1. Also when one reviews Prescrire's "Pilule d'Or" ("Golden Pill") Award list which is an award by the Prescrire editorial staff since 1981 to drugs that constitute a major therapeutic advance in a field in which no treatment was previously available, only 12 drugs received the Pilule d'Or award for a major therapeutic advance in a field in which no treatment was previously available in the period between 1981 and 2014.

No "Golden Pill" was awarded in 1982, 1984, 1985, 1990, 1991, 1993, 1994, 1995, 1997, 1999, 2000, 2001, 2002, 2003, 2004, 2005, 2008, 2009, 2010, 2011, 2012 or 2013.

Prescrire is a non-profit, continuing education organisation that is completely independent of any ties to government or industry and and its publications accept no advertising, grants or other outside support or any kind. It is a member of the International Society of Drug Bulletins and Prescrire's managers and editorial staff sign a yearly statement certifying that they have no conflicts of interest. The articles published in Prescrire are based on a search of the literature and critical appraisal of the evidence and each article is peer reviewed by 20-40 reviewers.

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