Law under the Microscope

NIH Announces Plan for Access to Trial Results

NIH finally announced its plan regarding the publication of clinical trial results and, as expected, the new policy will be to request that researchers post their trial results 12 months after completion of the trial. This policy angered many public access and taxpayer watchdog groups, who argued that 6 months was more appropriate.

More Troubles for Merck

I really do hate to harp on one major company's woes that are in the news, especially as I'm not a plaintiff's attorney and they are sure to do an excellent job highlighting the various ways that Merck failed to provide needed evidence regarding Vioxx research results. However, the latest bit to come out about Merck merits some discussion, if for no other reason but as guidance for other companies of all shapes and flavors about what not to say or use for lingo in your internal documents.

Merck, Vioxx - What did they know?

By now, just about everyone has heard about Merck withdrawing its blockbuster arthritis painkiller, Vioxx, because of potential side effects to the heart. Not only has it affected Merck's stock price (plunging 27% or so), it has started a mild panic about other Cox-2 inhibitor drugs. For a good explanation of these drugs, see Derek Lowe's blog In the Pipeline (scroll down to "How Bad are Cox-2 Inhibitors, Anyway?).

SEC Examining Biotech Companies

Recently, we've seen Eliot Spitzer, and then Congress breathing down the necks of biotech and pharma companies regarding the disclosure (or lack of disclosure) of their clinical trial results, and now the SEC is getting into the act. While this is not the first the time SEC has looked into potentially nefarious wrongdoings at biotech/pharma companies (for example, ImClone), it sounds like the SEC is taking a particular interest now with whether public companies are disclosing any negative clinical trial results on a timely basis.

It looks like at least the SEC's Boston office is scrutinizing the disclosure forms for regional companies:

House Committee Hears Testimony on Clinical Trial Disclosures

One of the issues that seems to be coming up again and again in recent months is disclosure of the results of clinical trials. Forest and GlaxoSmithKline must publish their results online under settlement agreements with NY's attorney general, Eliot Spitzer. Other major pharmaceutical companies have since also agreed to publish the results of their trials online.

Congress hasn't been soothed by these actions, though. Yesterday, the House Committee on Energy and Commerce had a hearing on Publication and Disclosure Issues in Anti-Depressant Pediatric Clinical Trials. The Committee members apparently took the FDA and pharma companies to task for not forcing the companies to disclose their results and not disclosing their results before the recent brouhaha, respectively.

GSK Settles, Publishes Summaries

As noted in a prior blog entry, GlaxoSmithKline had been sued by NY for failing to publish negative results from its Paxil clinical trials. Today, GSK settled that suit for $2.5 million to NY, and promised to publish the results of all studies conducted after Dec. 27, 2000 and related studies. However, they have 16 months to get all of these online.

I'm waiting to see whether the new publication of the clinical trial results by some in BigPharma will pressure others in BigPharma and SmallPharma to publish their trials ... or will NIH latch onto this as a good thing and get regulations passed to make it industry standard?

Clinical Trials in the News

On Tuesday, Eli Lilly announced that it would release the results of all clinical trials for which it is a sponsor in an online registry, whether or not the study met the desired outcome. This follows closely on the heels of NY's Attorney General Eliot Spitzer filing a lawsuit on June 2nd against GlaxoSmithKline for failing to disclose the results of its clinical trials for Paxil that showed negative results for use of the drug in adolescents and children. Lilly will begin posting the results for all trials that are completed after July 1, 2004, and for all drugs approved for market since 1994 (unfortunately, that obviously means that they're not going to tell us what happened to some of the other drugs that had been in the pipeline but didn't pass muster with or make it to the FDA).

Glaxo had also recently stated that it will release the results of all of its trials as well.