2014 Drug Issues: Where’s the Data, Product Hopping, Inappropriate Use, and What’s Come and Gone


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For 2015, I’d love to see headway in clamping down on drugs that don’t work, tighter regulation of inappropriate drug marketing, and more open data and transparency from industry. Is it pie-in-the-sky? Maybe. But let’s work towards it.

Patients need to be skeptical before pushing for a prescription or filling it. I’d urge you to search news accounts or blogs like mine on drugs that you are prescribed before you fill your next prescription. You might be enormously surprised and think twice before you grab your next Rx. You can send me questions on twitter @lauranewmanny or in the comments here. Below, I point to issues with specific drugs, more emblematic of the drug world than case examples that stand on their own.

Tamiflu (the antiviral drug oseltamavir for influenza) and the struggle for open data

It’s flu season and the flu vaccine will not cover some of this year’s flu strains. That still means that you should get a flu shot because the flu can be deadly. If you get the flu, you might be tempted to reach for Tamiflu, which is marketed all over television in the United States, pushed by the Centers for Disease Control and Prevention, but questioned by many respected health authorities. Massive stockpiling of the drug happened in the US and around the world. According to the US Government Accounting Office, the US spent about $1.3 billion on developing and stockpiling flu drugs like Tamiflu.

Leading the charge against Tamiflu are Yale’s Harlan Krumholz, MD, Ben Goldacre, MD, from alltrials.net, and the Cochrane Collaboration, the independent, global healthcare research group that performs evidence-based reviews. Krumholz summarized five key objections to the rampant Tamiflu marketing in Forbes: pointing out that 1) Tamiflu’s manufacturer, Roche, did not perform independent trials, nor were they independently vetted, and just 60% of randomized trial was released; 2) Tamiflu has demonstrated no benefit in reducing hospitalizations for the flu; 3) No conclusions from the trial data can point to reducing severe complications; 4) None of the data available back a benefit in terms of reduced transmission; and 5) At best, Tamiflu may reduce symptom duration by about less than a day.

After substantial publicity and hammering from these groups, the Cochrane Collaboration obtained a more complete data set and took a second look at the evidence on Tamiflu.In April 2014, Cochrane published its review, which held that “there is no good evidence to support claims that it reduces admissions to hospital or complications of influenza,” but that it did shorten symptoms of flu by half a day.

Fiona Godlee, BMJ Editor in Chief described the persistent efforts to get Roche to release all the data this way:

“This review is the result of many years of struggles to access and use trial data, which was previously unpublished and even hidden from view. It highlights with certainty that future decisions to purchase and use drugs, particularly when on a mass scale, must be based on a complete picture of the evidence, both published and unpublished. We need the full data from clinical trials made available for all drugs in current use. With the new European Clinical Trials Directive bringing in rules for future drugs, it highlights the enormous challenge we face. We need the commitment of organisations and drug companies to make all data available, even if it means going back 20 years. Otherwise we risk another knee-jerk reaction to a potential pandemic. And can we really afford it?”

Next up, I consider Namenda (memantine), approved for moderately severe to severe Alzheimer’s disease or dementia.

Last week, following an antitrust suit initiated by New York’s Attorney General Eric T. Schneiderman, a Federal judge issued a preliminary injunction that would stop Actavis, who markets Namenda, from retiring an older form of its drug to make way for a newer, more expensive form with a longer patent life.  Namenda costs about $1600 a year.

What pharma was trying to do is what is known as product hopping, where companies attempt to head off purchase of an affordable generic by eliminating the older brand. Thus, generics for the older drug cannot be made. It’s profitable — yes, but in patients’ interests, it’s doubtful.

Product hopping is a huge issue – not just for Alzheimer’s drugs, but it cuts across many drug categories. If you notice it happening with your drugs next year, check in with your elected officials, your State Attorney General. They just might be interested.

Another issue with Namenda is off-label use. It is prescribed to patient groups for which there is no proof that it works. In 2006, nearly 20% of the patients in the United States diagnosed with mild Alzheimer’s or dementia were prescribed Namenda, despite data showing that it is not effective. It’s not surprising that families are primed for Alzheimer’s drugs, given how feared Alzheimer’s and dementia are.

This post won’t review the evidence and clinical trials, but you can check out this in a paper authored by Dana Casciotti, PhD. The paper does a very good job of summarizing how overused and inappropriately used Namenda is relative to what has been shown in the studies performed to date.

Provenge

In yet another category, the prostate cancer vaccine Provenge, approved for metastatic hormone-resistant advanced prostate cancer, never caught on. In November 2014, Dendreon, makers of Provenge, filed for bankruptcy. Dendreon’s sole product is Provenge. Although the company promises to keep Provenge available, it had a rocky start from the beginning.

During the FDA approval process, it was mired in controversy and it is fair to say that urologists never became enamored with it. When I attended the annual American Urological Association’s annual meetings in 2007 and 2008 as a reporter, many urologists told me that they thought Provenge was going nowhere. These issues are covered quite well in the Cancer Letter in 2007 (behind a paywall), but the Cancer Letter offers excellent coverage.

Patient advocacy groups clamored for the drug’s approval. Also, given that treatment options for hormone-refractory advanced prostate cancer were limited to docetaxel, which had severe sides effects and only added 2 to 3 months to overall survival, the far less toxic Provenge, looked desirable.

In the early trials, several methodological concerns about the drug’s effectiveness were raised, including the failure to meet the phase III study’s primary endpoint, the claim of improved overall survival depending on a post-hoc analysis, as well as questions about the FDA’s approval standards changing in the middle of the approval process. Finally, a larger confirmatory phase III trial of Provenge, published in the New England Journal of Medicine, showed that median survival increased by over four months, compared with placebo. Provenge met muster for FDA approval in 2010. A full course of treatment cost about $93,000, which Medicare was covering at the outset, but private insurers resisted. Putting all these factors together, Provenge simply never caught on.

In closing, I want to emphasize that there are a huge number of drugs that I could have covered here. Obviously, this post is far from complete. If you find it helpful, let me know. I will cover more of these issues in 2015.

More importantly, if you like what you are reading, consider a donation to this independent blog (upper right on the front page). I spend hours researching this material and am compensated zip. I hope to bring an iconoclastic perspective and content that helps you make the best health decisions. Posts have become less frequent simply because I need to make a living, this blog is not monetizing, and no funders have risen to help out. I hope that you seriously will consider contributing.

Finally, best wishes for a healthy and happy new year! See you all after the first of the year.


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