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If the FDA acts more quickly, lower costs and better patient outcome will follow...In a January hearing, Sen. Hatch queried Dr. Janet Woodcock, director of the Food and Drug Administrations’s Center for Drug Evaluation and Research, whether the agency’s backlog of some 3,500 lower-cost generic drugs awaiting approval was contributing to the cost consumers pay for drugs...Dr. Woodcock conceded that...slow-paced drug approvals contribute to high costs...Eighty-eight percent of all prescriptions in the U.S. are generics. If the FDA acted more quickly with both generics and new drugs, overall health costs would go down and patient health outcomes would improve...By quickly approving generics, lower cost versions would be available without unfairly infringing on profits (and thus stifling innovation) that pharmaceutical companies need to recoup the high costs to bring new drugs to market...Ms. Warren (Sen. Warren, Mass, Democrat) said...She’d like us to believe that Mr. Shkreli is representative of the broader industry and only government price controls can protect consumers from what appear to be an ever-rising cost of drugs...Rep. Stephen Lynch, Mass. Democrat, proposed what he amusingly called a "poison-pill amendment," which would allow Congress to decide when drug prices are too high, and then just eliminate patent exclusivity and "contract with DARPA — our government research labs — to produce your drugs at no cost to the consumer. That’s what we can do."...The Lynch and Warren approach will do one thing for sure. It will have a chilling effect on much needed private-sector investment in pharmaceutical research...the "market-failure, price control" argument would translate to higher overall treatment costs...

Physicians are worth billions of dollars to drugmakers, who see the prescription pad as a path to profits. But it’s growing harder for Big Pharma to get doctors’ appointments. Since 2010, Obamacare has slowly curbed the mass travel junkets and fancy meals that drug companies once used to sway the doctors most valuable to their efforts to sell products...Pharmaceutical companies are now searching for ways to refine their marketing efforts, to target the doctors most compatible with the medications they’re pitching. "You’re desperate for data to make those key decisions,"..."But while there’s lots of data out there, it’s really challenging to bring it together."...Zephyr Health...promising to help drugmakers identify key medical personnel and find ways to approach them…Zephyr builds digital dossiers on individual doctors. It starts with basic information on prescription patterns from data clearinghouses...Then its software...scours the Web for more details...Zephyr generates profiles that score each doctor’s influence and ability to drive sales on a scale of 1 to 10. The software’s slick, mobile-friendly interface lets a drug company search in broad or specialized disciplines and ranks each person’s influence in the chosen field. It also specifies whether a doctor appears to influence colleagues or simply writes a lot of scripts..."There’s nothing private anymore,"...While doctors may not be exactly psyched about Zephyr tracking their every move...even they should appreciate the company’s ability to narrow marketing campaigns. For a physician, "working with Pharma is akin to getting pecked to death by a flock of ducks," he says. "Do you want nine salespeople queued up to call on you?"

Several leading pharmaceutical companies are joining forces in an effort to speed the testing of new types of cancer drugs that harness the body’s immune system to battle tumors...The cooperative effort, announced Monday, will include Amgen, Celgene, GlaxoSmithKline, Pfizer, Merck...and some smaller companies. The effort, known as the National Immunotherapy Coalition, will try to rapidly test various combinations of such drugs...“The challenge of cancer is far too great for any of us to tackle alone,”...Perhaps the most exciting development in oncology now is the sudden success, after decades of failure, of efforts to unleash the immune system to control cancer...The announcement of the coalition came on the first day of the huge J.P. Morgan Healthcare Conference in San Francisco, when numerous companies make announcements. Besides the coalition announcement on Monday, one company said Sunday it was aiming for what it called the holy grail of oncology — a blood test to detect all cancers at the early, most treatable, stage...

U.S. regulators have backed off an attempt to limit Pacira Pharmaceuticals Inc.’s promotion of its pain drug, striking an agreement that’s likely to fan the flames of debate over free speech and drug marketing...After the drugmaker filed suit citing its constitutional rights to free speech, the Food and Drug Administration agreed to let Pacira broadly promote the medication Exparel (bupivacaine), rather than limiting its sales team to talking only about its use after bunion and hemorrhoid surgeries...The painkiller, a non-narcotic shot, hadn’t been studied for use with other surgeries, such as dental or orthopedic procedures. While its FDA-approved label notes that fact, it doesn’t explicitly say the medication can only be used for surgeries that have been studied. Pacira argued that meant it could market the treatment for broader use...FDA has faced difficulty in its efforts to police drug marketing. In August, a court ruled the agency couldn’t bar Amarin Corp. from talking to doctors about unapproved uses of its fish-oil pill. While doctors are already allowed to prescribe drugs off-label, drugmakers have been restricted on promoting such uses...Drugmakers are able to give doctors information about unapproved uses if doctors specifically request it. The Amarin ruling allows pharmaceutical companies to hand out the information more widely without a request…

One-third of clinical trials conducted at 51 major U.S. universities and academic hospitals were never published in a peer-reviewed journal or in a government registry online, according to a new study...The researchers looked at 4,347 trials that were completed between October 2007 and September 2010. Of those, only 29 percent had results published within two years of finishing data collection, and 13 percent were posted on the government database ClinicalTrials.gov within the same period...about 67 percent of the studies disclosed their results by...2014...You’d like to think that academic institutions are role models for science...The truth is we’re not doing very well...University of Florida and Ohio State University joined Yale with some of the highest rates of publication in peer-reviewed journals...Boston University, Cornell and Oregon Health and Science University...had among the lowest rates...Pharmaceutical companies, the government and foundations invest a lot of money in clinical trials...If the results aren’t made public, that’s wasted money...Disclosure of results is critically important to advance science...Whether those results are positive or negative, and are important as a part of our agreements with funders as well as the participants in clinical trials...Beyond creating a data void that makes future research more difficult, unpublished results also may represent an ethical issue. Patients in clinical trials undergo experimental treatments with the understanding that doing so will advance medical knowledge, which can’t happen if the results aren’t published...

Former Turing Pharmaceuticals CEO Martin Shkreli was scheduled to testify to Congress today, but exercised his 5th Amendment right to not incriminate himself. Shkreli's lawyer...

• Why did you decide to pursue a managed care residency?
• What is the structure of your residency?
• What are your day-to-day tasks?
• How did you decide that your residency program was the right fit for you?
• What career opportunities does a pharmacy resident have after completing a managed care program?
• What advice do you have for students looking to pursue a residency in managed care?

Engineers at the University of California...say they have successfully 3D printed life-like liver tissue that simulates how the human liver functions and is structured. The researchers say the tissue could be used as a platform for drug screening...In the case of Federal Drug Administration approval for a drug, on average it takes around 11 to 14 years and $2.6 billion to get a drug to market...Around 90% of drugs don’t pass animal tests or human clinical trials. In the case of the new 3D printed tissue, the researchers say pharmaceutical companies could use the tissue as platform in the lab to focus on drugs that appear to be more promising and eliminate drugs that have less efficacy...To create the liver tissue that mimics real human liver tissue, the engineers created a diverse combination of liver cells and supporting cells systematically organized in a hexagonal pattern under a microscope. But to print that complex tissue, they needed a 3D printer that could accommodate the 3D micro-structures found in biological tissue. The team created their own bioprinting tech in the lab capable of reproducing the elements and features of the tissue…I think that this will serve as a great drug screening tool for pharmaceutical companies and that our 3D bioprinting technology opens the door for patient-specific organ printing in the future. The liver tissue constructed by this novel 3D printing technology will also be extremely useful in reproducing in vitro disease models such as hepatitis, cirrhosis and cancer...

In an extraordinary move, the International Committee of Medical Journal Editors last week issued a proposal　to require researchers to share their clinical trial data as a condition for publication. And the researchers would also have to submit plans for how their data can be shared. The journal editors, who represent such periodicals as The New England Journal of Medicine and the Annals of Internal Medicine, believe data sharing "will help to fulfill our moral obligation to study participants, and we believe it will benefit patients, investigators, sponsors, and society." The move comes after protracted tussling over access due to safety scandals that revealed trial data for some products was never fully published or disclosed. We spoke with Harlan Krumholz, who runs the Yale Open Data Access project and works with companies to publish trial data, about the implications.

• Why does this matter?
• So how big a step is it for these journal editors to issue such a statement?
• Why do you think it took this long to take this step?
• Of course, a researcher may not follow through and share data even after submitting a plan, which raises a question about enforcing the requirement.
• What do you make, though, of the editors at The New England Journal of Medicine? In a recent editorial, they expressed reservations and set off a ruckus by saying that some researchers worry about　‘research parasites.’
• How much push back do you anticipate from industry?

Public programs such as Medicaid are a necessity – not only for low-income families but for all the public, which benefits from a healthier population...These programs need access to affordable prescription drugs to treat those suffering from diseases like hepatitis and HIV. Unfortunately, their services are threatened by recent price increases from pharmaceutical companies like Turing and Gilead...I worry that such prices for prescription drugs are driving up spending for critical public programs like Medicaid, Medicare, and Tricare at unsustainable rates. We need to be able to cure life-threatening diseases for the low-income, seniors and veterans. But at these prices, it’s simply not feasible. Clearly something needs to change...