A few months ago, I wrote about some widely-reported research claiming that new drugs provide little, if any, improvement over their (often cheaper) predecessors. In fact, as I pointed out, the data supporting such claims can be problematic, and the media hype can be out of proportion to the findings. In this context, it might seem redundant to comment on yet another report that new drugs are less effective than old ones. But a recent piece by Donald Light, a sociologist on the faculty of UMDNJ, plumbs new depths for "pharmascolding" and deserves special attention. Here's the lead sentence:
A forthcoming article for the special issue of the Journal of Law, Medicine and Ethics (JLME) ... presents evidence that about 90 percent of all new drugs approved by the FDA over the past 30 years are little or no more effective for patients than existing drugs. [Original emphasis]
If this claim were true, it would be a profound indictment - of not just pharma, but the entire regulatory system and our whole approach to translating scientific insights into useful medicines. It might also, if true, merit the anti-pharma screed that follows in Light's blog post:
The bar for “safe” is equally low, and over the past 30 years, approved drugs have caused an epidemic of harmful side effects, even when properly prescribed. One in every five drugs approved ends up causing serious harm, while one in ten provide substantial benefit compared to existing, established drugs. ...
The forthcoming article in JLME also presents systematic, quantitative evidence that since the industry started making large contributions to the FDA for reviewing its drugs, as it makes large contributions to Congressmen who have promoted this substitution for publicly funded regulation, the FDA has sped up the review process with the result that drugs approved are significantly more likely to cause serious harm, hospitalizations, and deaths. ...
And Light is just getting warmed up. Much of the rest of the post is devoted to excoriating the FDA for being a co-conspirator with industry to foist high-priced, non-innovative, ineffective and downright dangerous medicines on the unsuspecting public. By the end, I wouldn't have been surprised to learn from Light of a secret pharma warehouse in Area 51 containing cures to Alzheimer's disease, cancer and the common cold that are being withheld in order to subject the masses to widespread illness.
As riveting as Light's post was, I tore myself away in order to read the "evidence" in the forthcoming article, which, as Light points out, is in a "special issue [of the journal], ... supported by the Edmond J. Safra Center for Ethics". Those facts are important because (a) "supported by" in this context commonly refers to a paid journal supplement that in many cases undergoes lighter review than a traditional research paper, and (b) the article containing the "evidence" is, in fact, co-authored by Light himself, a former fellow of Harvard University's Edmond J. Safra Center. So Light's blog post could be seen as a publicity vehicle for his article, which is, in turn, a form of paid publicity for the Safra Center.
With that context, let's look at the first two paragraphs of the paper, which bears the title, "Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs":
Institutional corruption is a normative concept of growing importance that embodies the systemic dependencies and informal practices that distort an institution’s societal mission. An extensive range of studies and lawsuits already documents strategies by which pharmaceutical companies hide, ignore, or misrepresent evidence about new drugs; distort the medical literature; and misrepresent products to prescribing physicians. We focus on the consequences for patients: millions of adverse reactions. After defining institutional corruption, we focus on evidence that it lies behind the epidemic of harms and the paucity of benefits.
It is our thesis that institutional corruption has occurred at three levels. First, through large-scale lobbying and political contributions, the pharmaceutical industry has influenced Congress to pass legislation that has compromised the mission of the Food and Drug Administration (FDA). Second, largely as a result of industry pressure, Congress has underfunded FDA enforcement capacities since 1906, and turning to industry-paid “user fees” since 1992 has biased funding to limit the FDA’s ability to protect the public from serious adverse reactions to drugs that have few offsetting advantages. Finally, industry has commercialized the role of physicians and undermined their position as independent, trusted advisers to patients.
At least we know where Light and his co-authors stand. As in the blog post, the article's semi-coherent ravings cover a wide range of alleged pharma and FDA malfeasances - but if one reads closely, one can find the "evidence" that led to the inflammatory "90% non-effective" claim:
The independent drug bulletin, La revue Prescrire, analyzes the clinical value of every new drug product or new indication approved in France. From 1981 to 2001, it found that about 12 percent offered therapeutic advantages. But in the following decade, 2002-2011, ... only 8 percent offered some advantages and nearly twice that many—15.6 percent—were judged to be more harmful than beneficial. A mere 1.6 percent offered substantial advantages. Assessments by the Canadian advisory panel to the Patented Medicine Prices Review Board and by a Dutch general practice drug bulletin have come to similar conclusions. No comparable review has been done in the United States on the 229 NMEs approved by the FDA between 2002 and 2011. [Emphasis added]
The "evidence" to which Light referred in his blog post is in a summary review in La revue Prescrire. For those who (like me) had never heard of this journal before, it is published by Prescrire, a "non-profit continuing education organisation, committed to better patient care". Teams from Prescrire's editorial board perform "expert reviews" on data for newly-approved medicines and rank the drugs on a qualitative scale that ranges from "bravo", "a real advance" and "offers an advantage" to "nothing new" and "not acceptable". Essentially, the publication's rankings are a cross between UpToDate and Consumer Reports - potentially useful and perhaps valid, but incompletely vetted, almost certainly irreproducible, and falling far short of what most academics would call bona fide "evidence". (Furthermore, as Light points out in his article, Prescrire's analyses are limited to drugs approved in France, and bear no relation to FDA approvals - in stark contrast to what he says in his blog post.)
I'm agnostic on the quality or conclusions of the Prescrire analyses, because vetting them on the basis of the underlying clinical data is outside my expertise. Furthermore, I can't argue with the point that regulatory agencies generally do not assess whether a drug outperforms the current standard of care (as registration studies may use other comparators), and it's therefore possible that many approved drugs fail to meet that bar.
However, Light and many other pharmascolds purport to be legitimate academic scholars - and as such, I believe they are professionally obligated to bolster their arguments with facts, not hyperbole, inflammatory language and partisan narrative. Blogs and articles like Light's do nothing to inform the public discussion of serious problems with our health care system and biopharma industry, and actually stifle thoughtful debate.
Furthermore, it's unfortunate that many serious stakeholders in healthcare choose to remain silent rather than speaking out to critique unprofessional and ill-informed "research" like Light's. There is a productive dialogue to be had regarding practical and ethical issues in drug development and approval, but only if all parties reject "pharmascolding" and focus their attention and the public's on the important issues at hand.