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Colombian Health Minister Alejandro Gaviria has vowed to find a way to force Novartis to lower the price of its Gleevec (imatinib) leukemia treatment. At first, he threatened to sidestep the drug patent to ensure low-cost generic production, but last week he took steps to unilaterally lower the price the government will pay for the medicine...So far, Novartis is not budging. The company argues that any move to jeopardize its patent would distort world trade rules, which, under certain circumstances, permit governments to overlook patents and secure a supply of needed medicines. Moreover, the drug maker notes there are several generic alternatives available to Colombians, so there is no need to haggle over the cost of its cancer medicine...the episode has quickly become an unfortunate litmus test in the struggle over patients and profits...A Novartis spokesman said the company is not threatening litigation against any of the generic companies, but he did not say what steps it might take...the drug maker may have to tough it out and provide Gleevec at a lower price...Novartis refused to give in. Doing so may have defused the crisis, but created a different problem. Drug makers worry that acceding to such demands might create a precedent that would encourage other countries to pursue the same tactic on other drugs. Similar battles have occurred in other countries, notably India, where drug patents have been sidestepped in a few instances...

First vaccine against lethal infection was 80%-90% effective in challenge study...A vaccine against cholera has, for the first time, received FDA approval...To be sold as Vaxchora, the product contains live but attenuated Vibrio cholerae bacteria. It is taken as a single oral liquid dose... the vaccine is indicated primarily for people traveling to areas where the infection is endemic...Vaxchora is manufactured by PaxVax Bermuda...

...Walgreens said...it would end its relationship with Theranos, in another blow for the blood-testing company that was once lauded for its innovative approach but has increasingly come under scrutiny...Walgreens said it would shutter all 40 Theranos Wellness Centers at its stores in Arizona, having already stopped Theranos laboratory testing services at its location in Palo Alto, California..."In light of the voiding of a number of test results, and as the Centers for Medicare and Medicaid Services has rejected Theranos' plan of correction and considers sanctions, we have carefully considered our relationship with Theranos and believe it is in our customers' best interests to terminate our partnership," Brad Fluegel, Walgreens senior vice president...Theranos was once praised for its fast, less-invasive blood testing technology but the company has found itself in the spotlight after media reports raised questions about the accuracy of its proprietary tests...Federal prosecutors from the U.S. Attorney's office and the SEC have investigated Theranos over whether it misled investors...

Doctors in states that track painkiller prescriptions were nearly one-third less likely to offer patients dangerously addicting opioids, a new study found...The launch of drug-monitoring programs in 24 states led to an immediate 30 percent drop in prescriptions for Schedule II opioids, the most addictive, in patients with pain complaints...We are moving in the direction of raising awareness about overprescribing these drugs...But we still have a lot to do in terms of changing the culture and practice of painkiller prescriptions...Drug-monitoring databases may make doctors think twice before prescribing pain medications for a variety of reasons in addition to uncovering "doctor shopping" by patients...Knowing that they’re being watched may serve as a deterrent, and the programs may generally increase awareness of the dangers of prescribing opioids...

Paris prosecutors...have begun an involuntary manslaughter investigation into a failed drug trial that left one dead and five hospitalized in January...The prosecutors' office said the investigation had been opened to determine whether there was a criminal element in any mistakes made or whether it was simply the result of clinical risks involved...France's Health Ministry said last month that Portuguese drugmaker Bial and French laboratory Biotrial were at fault "on several counts" for the drug trial...

Drug labels sometimes warn that the medications may disrupt sleep, but a new study suggests these drugs don't cause troubled sleep for most people...researchers found "barely" any link between medications that warned about potential sleep disturbances and actual sleep problems among thousands of people interviewed for the study...Sleep disturbances are a frequent problem especially in older people and we wanted to find out whether this might be due to the intake of sleep disturbing drugs... We found that drugs labeled as sleep disturbing . . . are not a major risk factor for sleep disturbances in the general population...Even taking a number of potentially sleep disturbing drugs barely led to more sleep disturbances...the individual or a specific patient can still suffer from sleep disturbances caused by drugs - especially drugs against diseases of the central nervous system...One limitation of the study is that the results are based on self reports by the participants and not devices that track sleep...

A congressional committee voted...to make changes to a controversial program that was designed to spur development of new drugs for neglected tropical diseases. But the effort...is still encountering criticism for not going far enough...At issue are priority review vouchers, which can be awarded to a drug maker that wins regulatory approval of a treatment for certain tropical diseases. Companies can later redeem a voucher when seeking approval for yet another medicine that would be used to treat any illness. And the Food and Drug Administration must review the other drug in six months, instead of the standard 10 months...critics say the program does not do enough to ensure drug makers develop needed salves. A chief complaint is that vouchers can be awarded to a company without having to invest in new R&D or even in a new medicine...House Energy and Commerce Committee...voted to address such concerns...For instance, companies would not be awarded a voucher for drugs previously approved in other countries; they would have to provide more information about plans to launch their tropical disease medicines outside the United States; and they would be required to provide data on patient demand worldwide.

Skyrocketing drug prices are forcing states to take unprecedented measures to rein in health care spending. Vermont just became the nation’s first state to require prescription drug pricing transparency. The New York and Massachusetts attorneys general have launched investigations into major pharmaceutical companies’ and insurers’ drug pricing policies and strategies...important steps. But they ignore a key driver of the problem: secondary patents...secondary patents work like this: Companies file for additional, defensive patents to thicken the protection around their original base patents. These additional patents rarely represent anything new in terms of science. Instead, their purpose is to prolong a company’s monopoly and, along with that, its ability to charge high prices for its drugs. Some drugs have dozens of secondary patents...

Colorado Gov. John Hickenlooper...signed legislation, S.B. 135, which expands collaborative practice for licensed pharmacists and opens the door for health benefit plans to provide coverage for pharmacists’ services...S.B. 135 allows pharmacists to enter into collaborative practice agreements with physicians and advanced practice nurses and grants licensed pharmacists the authority to provide healthcare services to patients under protocols delegated by a physician or advanced practice nurse. The law also authorizes pharmacists to provide care under a statewide drug therapy protocol developed by the boards of pharmacy, medicine, and nursing...the law does not require health plans to pay for pharmacists’ services...Health plans must reimburse pharmacists in their provider networks for services that would be reimbursed if provided by a physician or advanced practice nurse...

...the Colombian health minister plans to unilaterally force Novartis to lower the price for its Gleevec (imatinib) cancer medicine after more than two weeks of talks over a price cut went nowhere...In public comments today, Health Minister Alejandro Gaviria said he will declare a lower price for the widely used cancer medicine as being in the public interest because it would save the country needed health dollars. Under this scenario, Novartis would be obligated to sell Gleevec at the new price, although he did not specify what that might be...The battle over Gleevec has been closely watched as the latest manifestation of a global skirmish over the cost of medicines. Patient groups see it as a test case for using legal rights to ensure needed medicines are accessible, while companies see it as a potentially precedent-setting case in which a middle-income country use trade rules to lower its drug costs...