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In California…the “Compassionate Use Act,” too many of us remained quiet about the claims being made by people attempting to promote marijuana for their own agendas…The public approved the use of marijuana for seriously ill Californians to obtain and use marijuana for medical purposes, when recommended by a physician who has determined that the person’s health would benefit from the use of marijuana…There was no need for any placebo-controlled, randomized, FDA–approved study to be conducted — just the physician’s recommendation…The public has been duped by individuals whose main goal is to promote the legalization of marijuana… Keith Stoup, legal counsel for the National Organization for the Reform of Marijuana Laws, was quoted as saying, “We will use [medical marijuana] as a red herring, to give marijuana a good name.”…“in California, marijuana has been de facto legalized under the guise of medical marijuana.”…more than 23 states has approved marijuana for “medical” purposes, and four states and Washington, D.C., have allowed its recreational use, with taxation. To date, this social experiment has met with devastating consequences…Depending on when you graduated from pharmacy school, you pledged an oath. Whether you will abide by that oath to stay educated about pharmaceuticals and be a voice for appropriate drug use is up to you, but the public is relying on you to hold up your end of your oath.

European drugmakers say that at least as far as they are concerned, Japan is beginning to reap the benefits from its drug regulator's faster process of reviewing and approving drug applications…The head of the European Federation of Pharmaceutical Industries and Associations also applauded the changes in the "innovation premium" of Japan's Pharmaceutical and Medical Devices Agency pricing system that makes it more attractive to sell in Japan…EFPIA Japan Chairman Carsten Brunn said in an interview…that together the changes are also a boon to Japan, where 10% of the world's top 100 drugs that have not been available to patients are now entering the local market…The innovation premium system the PMDA adopted changed the system of setting price caps on drugs to ease its restrictions on innovative products…the Japanese patient would pay a higher price for those medicines…drugmakers now are conducting more clinical trials in Japan that in turn will result in more drug approvals. But, that would not have been enough incentive for… drugmakers…had the PMDA not speeded its approval process.

Healthcare IT security: you have a bad reputation. When it gets down to healthcare there’s always a little chuckle about how bad they are…This year was among the worst in cybersecurity across the healthcare sector…On average, companies that got breached did not know it for 270 days and some had even been breached for seven years without knowing it…that two-thirds of those entities did not even discover the breach internally; it was pointed out to them, either by someone outside the organization or by the federal government...As bad as breaches are, however, there are other worse threats emerging that hospital CIOs, CISOs and IT departments should understand and prepare for.

1. Ransomware
2. DDoS (Distributed Denial of Services)
3. Wiper attacks
4. Intellectual property theft
5. Straight theft of money
6. Data manipulation
7. Data destruction

The high cost of R&D is used to explain why drugs giants merge, and why they must charge high prices. The reality is somewhat different…Pfizer’s boss, put it, the merger will create “a leading global pharmaceutical company with the strength to research, discover and deliver more medicines and therapies to more people around the world.”…the common suggestion that size is needed to create a research-driven powerhouse does not stack up…the industry is…moving away from a model in which giant firms throw huge sums at in-house research in a quest for ground-breaking new treatments… rather than spending heavily in many different areas of cutting-edge research, the largest firms are increasingly buying in drugs that are already in the course of development. In some cases they do so by buying other established firms…the drugs giants are buying smaller, younger biotechnology firms which focus on a single-treatment approach…in the past 20 years those drug companies that consistently did well in various therapeutic areas were earning more than 70% of their sales from products developed elsewhere.

New numbers show Nevadans have been slow to jump into the state's health insurance exchange…Department of Health and Human Services reported Wednesday that 23,248 Nevadans bought coverage through Nevada Health Link in the first month of open enrollment, from Nov. 1 through Saturday…That's roughly half of the 40,285 residents who bought a plan through the exchange in the first month of sign-ups a year ago…Federal officials said enrollment should pick up as the Dec. 15 deadline nears to buy a plan with a Jan. 1 start date...Consumers without coverage in place by then face a federal tax for going without health insurance.

Allergan and New York State have settled a heated antitrust lawsuit that accused the drug maker of switching patients from an older dementia pill to a newer and more expensive version in order to avoid generic competition…Allergan agreed to pay $172,000 in litigation expenses and withdraw an appeal filed last month with the US Supreme Court…The arrangement ends a bitterly fought battle over a pharmaceutical industry practice known as forced switching or product hopping. This involves pushing consumers from one product to another. The case was closely watched because it held the potential to decide the extent to which a drug maker can force a product switch without running afoul of antitrust laws…The lawsuit triggered a debate over the sometimes controversial practice of reformulating a medicine and then obtaining a patent to extend its product life cycle. But the move by Allergan highlighted competing arguments over whether the strategy is really a ruse to create an unfair monopoly or is a legitimate use of intellectual property to protect a profitable product.

Before…Theranos suspended use of its finger-prick blood draws in September because of Food and Drug Administration concerns, the company tangled with Arizona lab regulators over testing instruments and lab practices…Theranos, which operates retail locations inside 40 Walgreens stores across metro Phoenix, did not always meet lab regulations before taking corrective steps, according to inspection reports…After an April 2 survey of the company's Scottsdale lab, Arizona Department of Health Services inspectors noted four "deficiencies" at the lab...The state inspectors conducted the survey on behalf of the federal Centers for Medicare and Medicaid Services, which regulates laboratory testing…The four issues concerned proficiency testing, validation of instruments used to analyze blood samples, humidity levels outside of acceptable ranges for some lab instruments and how blood-sample collections were dated…In September, state lab inspectors said that Theranos did not meet proficiency testing standards for certain substances, including toxicology and four other regulated substances.

Foreign pharmaceutical firms are looking for the bright side in Russia’s import substitution plan for the drug manufacturing sector…When…Prime Minister Dmitry Medvedev tasked the government with creating a program of import substitution in the field of pharmaceutical production, foreign companies were worried. Although Russia’s pharmaceutical market…a fraction of that of the U.S…its loss would have been a blow to Western drug companies at a time of global economic crisis...the policy may not have such serious implications…the import substitution policies will only affect sales to public health organizations, primarily state-run hospitals and pharmacies. Private health clinics and pharmacies are still able to import foreign drugs without restrictions…60 percent of the drugs on the List of Vital and Essential Medicines approved by Russian government bodies for use in public institutions are produced domestically. Under the new policy, this share should increase to 90 percent by 2018.

The congressman didn’t mince words when the Food and Drug Administration aired a plan to regulate diagnostic tests at a recent hearing. That could slow approvals, Representative Christopher Collins warned: “You run the risk of causing people to die.”…What Collins didn’t say at the hearing was that he has a financial stake in the issue: He co-founded a company that makes components for those tests. And he retains an ownership stake in that company, an asset he values at between $5 million and $25 million…Welcome to Congress, where such arrangements are legal — and to many critics, deeply disturbing…analysis of thousands of pages of congressional disclosure forms found that about 30 percent of senators and 20 percent of representatives held assets in biomedical and health-care companies, or in specialty funds set up to invest in those industries, during 2014…Some of the most aggressive congressional investors in the biomedical sector also sit on key committees, such as the House Judiciary Committee, which has jurisdiction over patent law, or the House Energy and Commerce Committee, which oversees the Food and Drug Administration and works on many issues of critical importance to the industry, including drug regulation, research funding, and taxes on medical devices…Members of Congress are not required to recuse themselves from voting on bills that could affect their personal finances, unless they would be the primary beneficiary of the legislation.

Lahey Hospital and Medical Center has agreed to pay $850,000 in a settlement with HHS' Office for Civil Rights to resolve alleged privacy and security violations stemming from the theft of a laptop computer with unencrypted patient records…health system also entered into a corrective action plan to address other privacy and security issues raised during the breach investigation. Lahey “impermissibly disclosed” electronic medical records of 599 individuals “for a purpose not permitted by the privacy rule” under the Health Insurance Portability and Accountability Act…Lahey had failed to meet a number of other HIPAA requirements, including not conducting “an accurate and thorough” security risk analysis, failing to assign “a unique username for identifying and tracking user identity” on the stolen computer and failing to “implement a mechanism to record and examine activity” on the computer.