It’s not specific to the West Coast, but anyone who needs to catch up on the week’s events should read the British Medical Journal’s re-analysis of a long-criticized study, dubbed Study 329, of the antidepressant paroxetine (Paxil) in an adolescent population. It took place in the 1990s, run by SmithKline Beecham (now GlaxoSmithKline). Paroxetine was approved for adults in the U.S. in 1992.
The original study was positive and, as the BMJ authors noted, “influential in the literature supporting the use of antidepressants in adolescents.”
Released Wednesday, the re-analysis had a much different conclusion. Not only was there no benefit compared to placebo, but also “there were clinically significant increases in harms, including suicidal ideation and behaviour and other serious adverse events in the paroxetine group and cardiovascular problems in the imipramine group.” (Imipramine is an even older type of antidepressant that was used as a comparator in the trial.)
Despite more than a decade of criticism, lawsuits, and massive fines against GSK in 2012 for fraudulent promotion of the drug, the original study has never been retracted—which means it remains in the official medical record.
In a separate editorial, a BMJ writer lays out the case against the original papers’ authors, and the universities where they conducted their research—in particular, lead author Martin Keller of Brown University. Keller sent a statement defending the original study to the website Retraction Watch.
If the re-analysis holds up, it’s a major step forward for a nascent movement to bring the growing support for data transparency not just to new studies but to old “abandoned” studies. It’s also a potent reminder that whenever possible, don’t take the experts at face value.
Let’s get to the roundup.
—Google Life Sciences, part of the newly renamed Alphabet (NASDAQ: GOOG) empire, has hired Thomas Insel away from the National Institute of Mental Health, where he had been director for more than a decade. Insel announced his move on the NIMH website Tuesday. Where Google plans to go in mental health remains an open question, although in a New York Times interview Insel offered the example of Google’s “sweet spot” of data analytics expertise being applied to the diagnosis of psychosis. (In more big federal medical news, the White House nominated FDA deputy and longtime Duke University cardiologist Rob Califf to be the next FDA commissioner.)
—Amgen (NASDAQ: AMGN) of Thousand Oaks, CA, said this week it would pay $300 million upfront for privately held Dutch firm Dezima Pharma, mainly to grab a late-stage cardiovascular drug that has reduced patients’ bad type of cholesterol in clinical trials. The drug, TA-8995, works the same way as Pfizer’s ill-fated torcetrapib, one of the biggest pharma failures of the past 20 years. Amgen could pay Dezima shareholders $1.25 billion more as Dezima’s assets hit various milestones. The deal comes less than a month after Amgen received FDA approval for its cholesterol-lowering evolocumab (Repatha), one of two recent approvals of drugs that block a protein called PCSK9.
—Seattle Genetics (NASDAQ: SGEN) closed a massive follow-on fundraising Monday that brought in more than $550 million, the company said. To put the figure in perspective, that’s five percent of the entire U.S. biotech follow-on total from 2014, which was second-highest in history after the year 2000, according to Ernst & Young.
—San Francisco digital health firm Omada Health raised a $48 million Series C round to expand the market for its chronic disease prevention program, Prevent. It combines online tools, social networking connections, and e-mail or phone coaching to steer people away from Type 2 diabetes and other obesity-related disorders. Omada says it has enrolled 20,000 people through health plans such as Humana and through employers such as Costco and Lowe’s. New investor Norwest Venture Partners led the round.
—Avalon Ventures has raised more than $100 million so far for its 11th venture fund, and hopes to raise as much as $300 million, according to a recent regulatory filing. That would be the biggest fund yet for the San Diego venture firm, which makes early stage investments in both technology and life sciences. Avalon X topped out around $250 million, and Avalon IX was $200 million.
—San Francisco’s Nurix, a biotech working on drugs that affect protein homeostasis, has inked a deal with Celgene (NASDAQ: CELG) to license future programs. Celgene is paying $150 million upfront and taking an equity stake of undisclosed size.
—LeafBio, the commercial arm of San Diego’s Mapp Biopharmaceutical, said Thursday that the FDA has granted a “fast track” designation to ZMapp, an experimental therapy for treating Ebola infections. Zmapp is a combination of three different monoclonal antibodies that LeafBio grows in tobacco plants. The FDA previously designated Zmapp as an “orphan drug.” Both designations provide financial and regulatory incentives meant to encourage the development of drugs for rare diseases and unmet medical needs.
—San Francisco-based Alector has reeled in $32 million for a drug discovery program that aims to boost a person’s own immune system to fight Alzheimer’s and other neurodegenerative diseases. Alector CEO Arnon Rosenthal discussed the similarities and differences of Alector’s approach to certain types of cancer immunotherapy, which also uses antibody therapies to stimulate the immune system. MRL Ventures, the venture arm of drug giant Merck (NYSE: MRK), is leading the investment round.
—Qualcomm Life, the subsidiary that San Diego-based Qualcomm (NASDAQ: QCOM) founded four years ago to focus on the Internet of medical things, has acquired Capsule Technologie, a healthtech systems developer based in Andover, MA, and Paris. Financial terms were not disclosed. Capsule’s flagship product pulls data from medical devices into a database, and the company has over 1,900 hospital customers in 38 countries.
—Amgen also announced a tie-up with antibody-based drug developer Xencor (NASDAQ: XNCR). Amgen is paying $45 million upfront for Xencor’s help developing up to six “bi-specific” antibody therapeutics, which means they can attach to two different targets at once. Amgen brought a bi-specific antibody to market last year, blinantumumab (Blincyto), which received a fast-track approval from the FDA for a rare form of leukemia.
—Celgene is paying $25 million to an academic consortium that specializes in antibody production for cancer therapeutics. The consortium comprises the University of California, San Francisco, the University of Chicago, and the University of Toronto. Its three cofounders, now spread amongst those schools, are all Genentech alumni.
—Raptor Pharmaceutical (NASDAQ: RPTP) said Monday that its drug to treat children with the liver disease nonalcoholic steatohepatitis, or NASH, failed a Phase 2b trial. Raptor’s share price has been cut nearly in half, from $12 a share to just under $7 at Thursday’s close. The data will be presented at a medical conference in San Francisco in November.
—XenoPort (NASDAQ: XNPT) of Santa Clara, CA, said Tuesday that a 200-patient, 12-week Phase 2 trial for its psoriasis treatment yielded positive top-line results, and its CEO said in a statement Phase 3 trials could start next year. But investors noted poor side-effect data and sent the stock down about 25 percent to $4.84 a share, and it has continued south since then, closing Thursday at $4.41.
—Ventrix, a six-year-old bioengineering startup in San Diego, has initiated a Phase 1 trial of VentriGel, a naturally derived biomaterial designed to help heart tissue regenerate after a heart attack. The technology, developed at UC San Diego in the bioengineering lab of Karen Christman, is regulated by the FDA as a biologic and in Europe as a medical device. The trial will enroll patients who sustained their first heart attack within the past three years.
—San Diego’s Molecular Response named Brett Hall as its new CEO. With Hall, a former Medimmune/AstraZeneca executive, the company aims to shift its business from diagnostics to therapeutics.
—Xconomy San Diego editor Bruce V. Bigelow contributed to this report.
—Photo of Alcatraz Island courtesy of Brian Shamblen via a Creative Commons license.