- The NIH is abandoning vital clinical research centers. That’s a mistake (statnews.com)Eulogy for the clinical research center (jci.org)
One of the most successful research enterprises funded by the NIH, the Clinical Research Center program, is dying, its highly productive life cut short...In 1910, Rockefeller University in New York built basic research labs around a suite of 20 or so hospital beds...this...translational research...using patient care to inform research and research to improve patient care...CRCs have provided human laboratories where diseases are studied and new treatments developed and tested. The CRCs include not only specialized inpatient beds and outpatient facilities, but a highly skilled group of research nurses, dietitians, research coordinators, technicians, and physicians who study patients with complex disorders...The decision to cut off funding for the CRCs comes as a surprise...the NIH leadership has ruled that funding...of the CRCs will no longer be permitted...This defunding is likely to lead to...abandonment of this vital resource for clinical research. The loss of the trained clinical nurses will be particularly damaging. The study of patients by academic physicians who intimately understand disease processes has long been under assault. Physician scientists, particularly those who focus on clinical research, have been marginalized in grant competitions for decades. The NIH’s unjustified decision to defund the CRCs further imperils their work...
- Independence of compliance reviews is questioned in drug firm settlements (reuters.com)
Some major U.S. drug companies have hired their own auditors to perform compliance reviews mandated in government settlements over alleged civil violations, such as paying kickbacks or off-label drug promotion, according to federal records...Third-party compliance reviews are playing an increasingly large role in helping the government ensure companies fulfill their obligations in federal settlements...Some lawmakers and legal experts say that practice creates conflicts of interest and could impair outside reviewers' independence...Susan Gillin, an attorney in the inspector general's office, said she agreed that "theoretically, a potential conflict of interest exists."...But she said her agency has not observed any problems with weak oversight by auditors serving in dual roles. Such arrangements are allowed, she said, as long as the firm is not involved in corporate management or advising on policies it will also review...Senate Judiciary Chairman Charles Grassley...said such arrangements could weaken enforcement..."If the firms enforcing the agreements aren't independent,"...that "defeats the purpose of the agreements."
- Resistance is Futile (pharmatimes.com)
This month, the UK government's review of antimicrobial resistance sent alarm bells ringing in Whitehall and issued a call for new medicines to kill antibiotic-resistant superbugs...When economist and government minister Jim O'Neill published the final version of his long-awaited report...its message was clear – antimicrobial resistance is perhaps the single biggest threat in modern medicine...O'Neill stresses the need for new antibiotics...A truly new class of antibiotic has not been seen for decades because the lack of incentives for investment has led to reduced R&D...Many of the 'low hanging fruit' in terms of development have already been picked... Antibiotics are given for just a short course of treatment and so sales are very limited. If a new antibiotic is reserved only for use in treating resistant infections, then most of the time it will sit on the pharmacy shelf not being used. Again this disincentivises any commercial company to develop new antibiotics...With a renewed focus on AMR, big pharma has started to take interest...
- Burden of pricey hepatitis C drugs heaviest in eastern Europe (reuters.com)Prices, Costs, and Affordability of New Medicines for Hepatitis C in 30 Countries: An Economic Analysis (journals.plos.org)
New hepatitis C drugs that can cure the liver-destroying disease are revolutionizing treatment but their high price is a huge burden in some countries, particularly in central and eastern Europe, according to a new study...An analysis of prices for two Gilead drugs by World Health Organization...found that while U.S. prices were higher in dollar terms, parts of Europe paid considerably more in "purchasing-power parity" terms...The PPP-adjusted price in Poland of a treatment course with Gilead's Harvoni was $118,754, against $72,765 in the United States...and it would cost 190.5 percent of the country's total drugs budget to treat all Polish patients...Gilead says the price of its treatments reflect their clinical, economic and public health value, arguing they are cost-effective over the long term.
- Over-the-Phone Cancer Counseling Found to Reduce Costs (specialtypharmacytimes.com)Patient-reported outcomes in a multicenter randomized study of in-person versus telephone disclosure of genetic test results for cancer susceptibility. (meetinglibrary.asco.org)
Providing genetic test results over the phone to patients at risk for cancer-causing genetic mutations does not cause individuals additional stress and could be an effective way to help reduce costs and access burdens compared with those who receive results in person, a recent study found...While health care providers deliver results for many tests over the phone, results of genetic tests have traditionally been delivered in-person because of the complexity, potential for increased levels of distress, or confusion over what the results could mean...delivering results over phone...does not generate more distress, even for those with positive results and even now that we are using multi-gene testing...those who received their results over the phone had fewer barriers in accessing genetic counseling services compared with patients given their results in-person.
- Drugmakers can’t charge beyond making costs for compassionate use: FDA (reuters.com)
Food and Drug Administration said companies could only charge patients for the cost of manufacturing experimental treatments used under compassionate grounds, and it cannot force government or private health insurers to pay for these drugs..."Compassionate use" of experimental drugs allows physicians to prescribe unapproved treatments for patients who have no other satisfactory alternatives in the market...The FDA's move seems to be intended to soften the repercussions of its possible rejection of Sarepta Therapeutics Inc's muscle-wasting drug (Duchenne muscular dystrophy)...FDA last week deferred its decision on whether to approve Sarepta's drug, eteplirsen, after an advisory panel determined that the treatment was not effective...The FDA is trying to create a compromise, saying drug companies can charge for a drug even if its not approved...Sarepta's drug has been in the spotlight over the past few months with patient groups and parents arguing passionately in favor of the treatment to pressure the regulator to approve the drug.
- Want to win $2 billion? Create the next antibiotic. (washingtonpost.com)
The prices of antibiotics are too low. Low prices reduce the barrier to prescribing antibiotics, while high patient demand fosters overprescribing. Consequently, an estimated 20 to 50 percent of antibiotics dispensed in hospitals and about a third of those prescribed in physicians’ offices are inappropriate or unnecessary. Overuse breeds resistance...low prices discourage the development of new antibiotics…Even without a superbug, the CDC estimates that more than 2 million people annually are infected with antibiotic-resistant bacteria and more than 23,000 people die as a result...Unless we shift course, superbugs will become a fact of life. Here is a four-pronged approach that might work:
- every hospital must implement a drug stewardship program to reduce inappropriate antibiotic use.
- reduce inappropriate prescribing for colds, sore throats and other, mostly viral or self-limiting minor ailments, every antibiotic prescription should be electronically reviewed to be certain it meets national guidelines.
- the government and industry should collaborate to fund pre-clinical research on antibiotics — in other words, studies of how drugs get into and fight infections.
- we need financial prizes for researchers and companies who develop new antibiotics.
- Pharmacy Week in Review: June 3, 2016 (pharmacytimes.com)
Mike Glaicar, Business Development: Pharmacy Times...(PTNN) This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- Money-back guarantee: the new trend in drug and device marketing (statnews.com)
Imagine buying a new car only to learn that it doesn’t work as advertised and there’s nothing you can do about it. That’s essentially what happens when you take a pricey medication...there’s no guarantee it will work and you won’t get your money back if it doesn’t...In most realms of commerce, if a product fails to deliver what’s been promised, consumers are financially covered through refunds and warranties. This has never been the case with pharmaceuticals...to stem the growth of health care costs, hospitals, private insurers, governments, and other purchasers of these products are resisting price increases and the introduction of expensive new products. They are also looking for more evidence of effectiveness. At the same time, drug and device makers need new ways to convince skeptical payers that their products are worth the price….If the product doesn’t work as intended, you don’t pay...Cigna has announced signing contracts for two new cholesterol-lowering drugs that would reduce the price paid if real-world outcomes don’t match the results of clinical trials. Cigna will be given access to patients’ cholesterol levels and be able to tell how well the new drugs are working.
- NGO questions drug industry backing of G7 antibiotic preservation pledge (in-pharmatechnologist.com)
Industry backing for a G7 plan to preserve antibiotics is at odds with current marketing practices says an NGO calling for a clamp down on campaigns that promote overuse...This week a pledge by G7 leaders to address 'market failures' that discourage antibiotic R&D and encourage over promotion won the support of the Association of the British Pharmaceutical Industry...The ABPI welcomed the ・commitment for collaborative global action by the G7 on tackling the unique medical, scientific and economic challenges presented by antimicrobial resistance・ telling us antibiotic stewardship was a core focus of the industry declaration launched at World Economic Forum meeting in Davos...industry support for efforts to preserve antibiotics is disingenuous according to Gemma Buckland Merrett, senior research Manager at NGO Health Action International, who suggested current marketing practices are part of the problem..."Evidence is starting to show that increased marketing of antibiotics by the pharmaceutical industry may be exacerbating inappropriate antibiotic use" Merrett told us...Despite the risks of resistance, pharmaceutical companies have continued to market antibiotics, often incentivising medical and veterinary personnel to overuse or inappropriately prescribe antibiotics.