Author: Peter

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."

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...

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.

Placing trust in science can be easier when findings are confirmed, but a new survey finds that most scientists believe there is a "crisis" in reproducibility...Specifically, 52 percent reported that replicating results is a "significant" problem and another 38 percent believe a "slight crisis" exists. More than 70 percent of researchers have tried and failed to reproduce another scientist’s experiments, according to Nature, which canvassed 1,576 researchers. And more than half of the respondents reported that they failed to reproduce their own experiments...Yet one-third believe that failing to reproduce results means that a study is probably just incorrect, and most of those asked say that they continue to trust published findings. Moreover, 73 percent think that at least half of the papers in their own fields can be believed...Merck executive recently suggested that drug makers should be entitled to get their money back for potential treatments licensed from universities if the company is unable to reproduce the results in subsequent experiments...the pharmaceutical industry has been under pressure to release trial results in order to verify claims about their medicines. The issue accelerated in the wake of several scandals about undisclosed side effects...

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.

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.

For more than 15 years NICE has punched above its weight internationally but as it comes under attack for its methodology, will its international clout suffer?...The bad headlines are back; on 20 May, the National Institute for Health and Care Excellence...came under fire from the media for its decision to bar Roche's Perjeta (pertuzumab) for breast cancer from the NHS...While patient groups and charities are worried about the effect on cancer patients in England, who may be denied treatment, there may also be a knock-on effect in other countries, which still look to NICE for guidance over their own reimbursement decisions...NICE International...advises countries from Ghana to Kazakhstan on HTA (health technology assessment) methodology and implementation...Yet, its international spread has come hand-in-hand with the growing disillusionment about NICE's decisions...An IMS Institute study in 2013 compared the reimbursement of cancer drugs in five countries that used cost per QALY (NICE's quality-adjusted life years) methodologies, including the UK, with five using broader methodologies, including Germany and US. It found that the cost per QALY countries reimbursed fewer cancer drugs, had slower access to those they did adopt, and generally performed poorer in terms of cancer outcomes. Moreover, it was not clear that they saved much money.

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.

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.

Rite Aid announced...the grand opening of its new distribution center in Spartanburg, S.C....first in 16 years," stated John Standley, Rite Aid chairman and CEO. "Featuring highly efficient and advanced technologies, this facility will play a crucial role in our company’s supply chain, supporting more than 1,000 Rite Aid stores across the southeastern United States, and help us deliver a superior customer experience."...approximately 600 new jobs...will have a tremendous impact on the entire state and is a testament to the competitive business environment...The 900,000 square foot distribution center sits on 97 acres...Some of the features of the new facility include:

• High efficiency LED and T5 fluorescent light fixtures and occupancy sensor controlled warehouse lighting;
• An on-site truck maintenance facility, including a fueling station, trailer weigh scale and wash area;
• High-speed automated palletizers, ergonomically designed manual palletizing stations and automatic label applicators;
• State-of-the-art warehouse and labor management system;
• Voice pick technology; and
• 60,000 square feet of office space, including an associate cafeteria, fitness center and other amenities.