This week, vaccine manufacturers won increased protection from liability in a closely watched case before the US Supreme Court. In Bruesewitz v. Wyeth, the Court ruled that federal law prohibits patients who claim to have been injured by a vaccine from suing the manufacturer. Pfizer hailed the decision as a victory for public health, but its effect is to diminish patients’ recourse when they suffer harm from taking faulty products. Read more »

Patients who take biological drugs traditionally have had little choice but to submit to injections. Yet needlephobes should take heart. Several partnerships are developing other ways to deliver large molecules that seem to show promise. Read more »

Pharmaceutical companies sometimes explain their unimpressive pipelines by saying that it’s become harder to discover and develop new drugs. Believing that the low-hanging fruit has been picked already, manufacturers are focusing on serving small patient populations. But a new paper suggests that the industry may be overlooking the potential of a particular class of drugs to treat tens of millions of patients. Read more »

Have you ever allowed yourself what you thought was ample time to drive somewhere, only to be delayed by a construction crew that was repairing the roads? Obviously, things don’t always work out as we plan them. Judging by its latest announcement about its facility ameliorations, Genzyme (Cambridge, MA) must have learned this lesson, too. Read more »

Patients rely on doctors to make impartial decisions about the most effective treatments for their conditions. In recent years, public advocates have agitated for restrictions on pharmaceutical companies gifts’ (e.g., meals, honoraria, or entertainment) to medical professionals on the grounds that they could unduly influence prescribing habits. In what seems like a fight against transparency, Pfizer (New York) sent employees to Connecticut’s capitol to protest a state bill that would restrict such gifts and require reporting. Read more »

Friday the 13th was an unlucky day for Genzyme (Cambridge, MA). On that day, the company and the US Food and Drug Administration alerted healthcare providers that stainless steel fragments, nonlatex rubber, and fiberlike material had been found in products filled at Genzyme’s Allston Landing manufacturing facility. The enzyme-replacement products Cerezyme, Fabrazyme, Myozyme, Aldurazyme, and Thyrogen were affected. FDA advised that visual inspection and filtration of the products should reduce the risk of administering contaminated medicines to patients. Read more »

In a news release issued by the European Organisation for Rare Diseases (EURORDIS) this week, the society commended the European Medicines Agency (EMEA) in its efforts to make the information that it has available on medicines more patient-friendly. Read more »

The pharmaceutical and biopharmaceutical industries have jealously guarded their intellectual property for years. Companies routinely use patents to prevent competitors from making generic versions of their drugs. When pipelines have weakened, companies have developed new formulations or delivery methods to extend patent protection for their established drugs. The economic crisis has only sharpened this reflex.

That’s why news from Ecuador made me do a doubletake. Read more »

This month, lawmakers such as Senator Kent Conrad (D-ND) and Senator Edward Kennedy (D-MA) have introduced a flurry of healthcare-reform bills that provide for comparative-effectiveness (CE) research. Supporters of CE research say that it could cut unnecessary costs by identifying the treatments that produce the best results. Federal and state governments’ share of the national healthcare bill could consequently be lighter, yet critics fear that promoting CE research could give the government too much power over treatment. Read more »

Pfizer (New York) has apparently agreed to settle allegations that it conducted an illegal clinical trial of its meningitis drug trovafloxacin in Nigeria. Eleven children died during the trial that prosecutors say was unlicensed. It would be impossible to establish drugs’ safety without clinical trials in humans, but the settlement agreement is more grist for those who say that trial patients’ rights and health are not sufficiently protected. How will regulators respond? Read more »