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Federal authorities have announced that they are reviewing the possibility of loosening the classification of marijuana, and if this happens, it could have a far-reaching impact on how the substance is used in medical settings...Marijuana is currently classified as a Schedule I drug, meaning it is listed alongside heroin and LSD as among the "most dangerous drugs" and has "no currently accepted medical use and a high potential for abuse."...The Drug Enforcement Administration announced last week that it is reviewing the possibility of reclassifying it as a Schedule II drug, which would put it in the same category as Ritalin, Adderal and oxycodone...There are thousands of people who are using medical marijuana for a whole host of medical conditions...where the efficacy has yet to be thoroughly studied...By changing the classification of the drug...researchers and doctors could find out how effective marijuana is in other conditions...We could move toward a more evidence-based use of medical marijuana... For too long schedule I status for marijuana has been a barrier for necessary research...

...Medicare is in trouble...The program -- designed to protect our nation's senior citizens by covering some of the eligible costs tied to their hospitalization and outpatient care -- is on an unsustainable course...the Hospital Insurance Trust Fund stands just an estimated 14 years away from burning through its excess cash reserves...2030 would be the year Medicare's HI Trust exhausts its cash reserves...Once the cash reserves...are exhausted, hospitals would only be reimbursed at a rate commensurate to what the program brings in via payroll tax revenue...Medicare's prescription drug problem...prescription drug costs that Medicare Part B covers...include injections given on an outpatient basis by a physician...the real culprits the GAO report identified for rising Medicare Part B expenses are new Part B prescription drugs...between 2007 and 2013, new prescription drug introductions...83 in total, added $5.4 billion in costs to Part B...almost two-thirds of Part B new drug treatments are for ophthalmologic or cancer-based diseases...these are not inexpensive indications...Nine drugs wreaking havoc on Medicare's bottom line (total expenditures in 2013)...

• Lucentis: $1.37 billion
• Eylea: $1.09 billion
• Prolia: $665 million
• Treanda: $332 million
• Lexiscan: $257 million
• Yervoy: $224 million
• Privigen: $184 million
• Provenge: $183 million
• Soliris: $150 million

Domestic and foreign drugmakers in Japan may cut spending on R&D as the scope of mandated price cuts for reimbursed products kicks in--suggesting that future investments are at stake...Pfizer and Eli Lilly have raised the issue as a combination of price reviews for pharmaceuticals hits in one of the top 5 reimbursement markets globally...Without stability and predictability in drug prices, investments will go elsewhere...cost cuts raise the risk of less investment in Japan...Reimbursement in Japan was a double-whammy this fiscal year that started April 1 for many drug firms, with price cuts for widely prescribed drugs by Japan's Central Social Insurance Medical Council, known as Chuikyo, reaching as much as 50 percent...Under the formula, drugs with annual Japan sales of more than ¥150 billion ($1.8 billion) and that see sharp sales gains can face cuts...On top of that, the every-other-year price-cut exercise by the government at the same time aims for savings of $1.5 billion. The exact revenue losses for companies won't likely be known until second-quarter results are released--although several companies flagged the issue in fourth-quarter earnings calls... Japan's Ministry of Finance has suggested the price cuts need to be every year as healthcare costs balloon along with a rapidly aging society that requires increasingly expensive care...

A tussle between a Texas compounder and the Food and Drug Administration underscores the ongoing difficulties that regulators can have overseeing this controversial portion of the medical supply chain...The episode also illustrates how varying approaches taken by state and federal authorities to regulating compounding pharmacies can leave doctors and patients confused about the safety of medicines...the FDA issued a health alert recommending that doctors and patients should toss sterile medicines made by IV Specialty. The agency found numerous safety issues during an inspection...the compounder refused an agency recommendation to halt production or issue a recall until the problems were fixed...The FDA...lacks authority to force the compounder to take these steps...In response to the FDA actions, the state agency (Texas State Board of Pharmacy) sent its own inspector to review IV Specialty facilities...According to our rules, they’re doing what they need to do. We didn’t see anything that we felt would prompt us to immediately close them down...state regulations are not as stringent as FDA regulations..."We’re still in the early stages of figuring out how state and federal regulation schemes are going to work," said Elizabeth Jungman, director of public health programs at Pew Charitable Trusts, which tracks compounding issues. "So it’s confusing for patients and physicians to see disagreement between regulators at state and federal levels."

The Centers for Medicare and Medicaid Services has been letting patients grade their hospital experiences, and those "patient experience scores" may give some insight into a hospital’s health outcomes...Some people have been concerned that patient experience isn’t the most important factor to measure...Medicare has been putting a lot of data out for a long time, but the broad consensus has been it’s very hard for consumers to use this info...CMS responded by giving out star ratings that consumers can understand easily...The five-star rating system is based on patients’ answers to 27 questions about a recent hospital stay...If you use the star rating you’re more likely to end up at a high quality hospital...But I wouldn’t use only the star rating to choose a hospital...

A Medicare proposal to test new ways of paying for chemotherapy and other drugs given in a doctor's office has sparked a furious battle, and cancer doctors are demanding that the Obama administration scrap the experiment...At issue are some of the most expensive drugs for treating life-changing diseases...Medicare now pays doctors and hospital outpatient clinics the average sales price of a drug, plus a 6 percent add-on, somewhat reduced by federal budget cuts. Naturally, 6 percent of a $15,000 drug is more than 6 percent of a $3,000 drug. But does that influence doctors' decisions, raising costs for the government as well as those on Medicare?... The new formula...combines a 2.5 percent add-on with a flat fee for each day the drug is administered...The experiment could become permanent policy if it lowers costs while maintaining quality...Specialist doctors, drugmakers and some patient advocacy groups are trying to compel Medicare to drop the plan. Primary care doctors, consumer groups representing older people, and some economic experts want the experiment to move ahead...Opponents say if that happens, cancer patients will be forced to go to outpatient hospital clinics instead of their local cancer doctor for the latest and most effective drugs. That's because smaller, doctor-owned clinics may no longer be able to afford the upfront costs of cutting-edge medications. In rural areas, patients may have to travel long distances to get to a hospital clinic...

A Colorado lawmaker (Dan Pabon) is trying to outlaw marijuana-laced gummy candies that resemble children's treats, the latest effort...to address the complexities and unintended consequences of pot legalization...In 2014 Colorado became the first state to allow the sale of marijuana for recreational use, and it has grown to be a billion dollar industry in the state...there are no distinguishing characteristics between the gummy bear that contains marijuana and one that does not...Numerous children in Colorado were hospitalized after becoming critically ill as a result of ingesting edible marijuana products after pot became legal...

The Department of Health and Human Services has proposed allowing physicians to prescribe buprenorphine for twice as many opioid-addicted patients as they do now...Buprenorphine is a medication-assisted treatment for opioid use disorder, and certain physicians are permitted to prescribe or dispense the drug in their offices because it has low potential for abuse...Under current usage guidelines, physicians looking to prescribe and dispense buprenorphine must participate in training before receiving a special Drug Enforcement Administration number. Physicians certified to prescribe buprenorphine for opioid use disorder are currently permitted to prescribe it to up to 30 patients in their first year and then request authorization to prescribe it to up to 100 patients—a cap that HHS said "limits the ability of some physicians to prescribe to patients with opioid use disorder."...If the HHS proposal is adopted, then qualified and currently waived physicians will be able to prescribe buprenorphine for up to 200 patients.

The worlds of science, technology and patent law eagerly await the...government’s decision on who deserves patents on what many have referred to as the biotechnology invention of the century: the CRISPR/Cas9 gene-editing technique...Scientists hail CRISPR/Cas9 as more accurate and efficient than other, now-traditional genetic engineering methods...CRISPR has generated worldwide debate about how it could accelerate the manipulation of plants, animals and even human beings at the molecular level. That some DNA modifications can be passed on to future generations raises particular concern...But the patent dispute, focusing on whether scientists at the Broad Institute of MIT and Harvard or those at University of California, Berkeley invented the technology, seems far from these ethical concerns...the...Patent and Trademark Office, which will make a decision in the next few months...But amid all the breathless anticipation, we’ve been ignoring two important lessons from the CRISPR/Cas9 patent dispute: patent systems no longer fit the realities of how science works, and patents give their owners significant control over the fate and shape of technologies.

• Do we need patents to stimulate innovation?
• Power of patents, in absence of regulations
• CRISPR’s future use in one institution’s hands

Food and Drug Administration...moved to revoke approval of a drug used to treat certain conditions in pigs because it could leave a cancerous residue that may affect human health...The drug, carbadox, is made by Teaneck, New Jersey-based Phibro Animal Health and is used to control swine dysentery and bacterial enteritis...It has also been used to promote weight gain in pigs...Potential cancer risks are based on an assumed lifetime of consuming pork liver or other pork products containing carbadox residues...adding that it is not recommending that people change their food choices while it works to remove the drug from the market...The FDA said it asked Phibro for additional information about the safety of carbadox but the company has not submitted any proof that there is a safe way to use it...Three antibiotics made by Phibro contain the drug: Mecadox Premix 10, Banminth/Mecadox; and Mecadox/Terramycin...