Study: Patients Cared For by Female Doctors Fare Better Than Those Treated by Men

A new study, published in Journal of the American Medical Association (JAMA) International, reports that Medicare patients over the age of 80 were less likely to die or be readmitted within 30 days if they were treated by a female doctor; estimates based on the findings indicate that as many as 32,000 annual deaths may have been avoided if the provider had been female. While the study does not draw conclusions regarding why this is the case, anecdotally, experts hypothesize that females are generally better communicators and have higher levels of emotional intelligence. These skills play an important role in not only working with patients, but also when working with the nurses who arrange discharge, social work, home care, etc, and the family members who will play a large role in treatment after discharge.

Listen to the NPR podcast on it here.

Chicago Will License Pharma Sales Reps to Fight Opioid Overprescribing

Chicago will enact a new requirement that all pharmaceutical sales reps maintain a license based on their training for ethics, marketing regulations and industry laws; at a cost of $750, the reps will be responsible for applicable fees and annual renewals. The new ordinance also requires paperwork to be filed with the city regarding the reps’ activities and physician contact. The new regulations come after Chicago filed lawsuits against multiple drug manufacturers and their role in the current opioid epidemic. The fees are expected to exceed $1 million for the city, which will then be used to support ongoing education efforts, regulatory costs and expanding treatment availability for addicts. The pharmaceutical industry argues that the new requirements do nothing to curb opioid abuse.

Read a Stat News article on it here.

Should We Use Canada and The WHO's 'Essential Medicines' as Guides for US Drug Pricing?

Revamping our Nation’s approach to drug pricing will be a daunting task and is one that the public is expecting from our next president. Experts suggest a foundation be built from two main sources:

1. The World Health Organization’s (WHO) Essential Medicines list: Containing over 445 medicines deemed as essential in satisfying the priority health care needs of a population, the Essential Medicines list could serve as a model for the U.S. in identifying important drugs that should be protected from price surges and available to the entire population.

1. The Canadian approach to drug pricing includes a review of efficacy, quality and safety; the proposed price by the manufacturer; prices of competing medications; and prices set in other countries. Negotiations for drug prices include the pan-Canadian Pharmaceutical Alliance and a price is determined for all provinces of the country.

Read Stat News' article on it here.

[Podcast] A Powerful Duo Against HIV

Summary: Current treatment for HIV is a lifelong regimen of antiretroviral drugs that place significant economic and clinical stress on the patients being treated. Additionally, if individuals stop taking these drugs, the virus quickly multiplies and rebounds to its original levels. A major component in the weakening of the immune system by the virus occurs through the destruction of immune cells in the gut. The virus targets these cells, forcing the body to work continuously to repair the damage and, subsequently, pulling needed resources from the rest of the immune system. Researchers have developed a therapy to destroy the protein attached to the cells that directs them to the gut and allows the body to mount a system-wide immune response during infection. When used after a course of antiretrovirals, monkeys receiving the new therapy have been able to control the infection without additional treatments for two years. A safety study for use in humans is currently underway.

You can hear the podcast here.

A Cure for a Childhood Cancer - but Will It Last?

Article Summary: CAR-T, an experimental treatment for cancer that supercharges the patient’s immune system by genetically modifying immune cells, has had incredible results at high risks. However, the risks of the treatment include death, though many of them are seen as terminal without the treatment, and a new concern is that the cancer will return. It is unknown if the results of the treatment are permanent or if the cancer will return and, if it does, how quickly this will occur.

You can read MIT Technology Review's article on it here.

Podcast: The Flu, the Shot, the Future

Podcast Summary: The CDC recommends that almost everyone get the flu vaccine. While the inhaled version is currently not recommended, due to ineffectiveness in the past three seasons, the injection method is still only about 63% effective. The probability of contracting the illness might seem high; however, the CDC estimates that the vaccine prevented over seven million flu cases during the 2013/2014 season. For those who contract the illness, questions have arisen regarding the use of Tylenol to reduce fever and how it may impede on the body’s own immune response. While a study in New Zealand indicates that there is no difference in flu duration, concerns regarding the study’s size and compounding factors (including the use of Tamiflu) make the results inconclusive. Further, the effectiveness of Tamiflu is also under fire; an examination of published studies indicating duration and severity reduction revealed improper methodology and consistent bias. Actual review of the data presented to the FDA shows a much lower level of effectiveness than previously thought. As some work to develop effective treatment options, other researchers have identified portions of every flu virus, regardless of seasonal evolution, that remain unchanged. There is hope that if they can develop a vaccine to target these parts of the virus, annual administration with limited effectiveness will no longer be necessary; lifetime immunity similar to that for measles and mumps could be achieved with a single injection.

You can hear the podcast from 2 Docs Talk here.

The Pluses, Minuses of Drugmakers' Discount Cards

While discount cards can assist patients in covering out-of-pocket expenses, their use by drug manufacturers to steer users to more expensive drugs ultimately drives up costs in the healthcare system. Many coupons and discount cards are targeted at expensive brand name medications; while they allow the patient to afford their established copay, the insurer is paying the balances of a significantly more expensive drug than the generic or preferred brand – oftentimes, leading to higher premiums the following years. Further, these discounts are usually limited to a certain number of fills or restricted timeline and cannot be used by patients in federal health plans.

Read Drug Discovery & Development's article on it here.

[Medscape Podcast] Biosimilars: Can They Be Trusted?

Podcast summary: The first biosimilars were released in Europe ten years ago and were based on biologics with fairly simple structures. As technology and understanding expands, manufacturers are approaching a more complex set of drugs; some critics worry that, while researchers are able to easily map the sequence of proteins, the actual structure of a biosimilar may have slight, undetected variations from its counterpart. Industry experts, however, are confident that the advancement of the technology used to compare the chemical makeups is so precise that any undetected structural error would be too minor to impact the drug’s efficacy or safety. Additional concerns stem around clinical trial requirements – while the original biologic required rigorous testing with thousands of people, trials to prove equivalence (rather than efficacy) are typically much smaller in nature. On the other hand, equivalence studies are much more affordable, lending this approach to the cost containment initiatives that make biosimilars attractive in the first place. Further, regulatory agencies will also likely require extensive additional evidence of drug similarities, supplementing required trials, before any approvals are issued.

Hear Medscape's podcast here.

Podcast: Aetna Letter Sparks Controversy

Summary: After announcing an exit from the majority of the healthcare exchanges in which it currently operates, Aetna is receiving criticism over a letter it had previously sent to the Department of Justice (DOJ). In it, Aetna’s CEO stated that if the merger between his organization and Humana was blocked, the company would have to leave the exchange business. Aetna claims to have left due to financial concerns and profitability issues with the program setup, but some wonder if the letter was meant as a veiled threat. Experts point out that if the latter is true, the attempt was misguided – the DOJ typically does not consider political pressures when examining anti-trust cases and is attempting to block the merger regardless of the letter’s intent.

Hear the full podcast from Marketplace here.

Fearing Zika, FDA Asks Two Florida Counties to Halt Blood Donations

After travel and sexual transmissions were ruled out for four Zika cases in Florida counties of Miami-Dade and Broward, fears of infected mosquitos in the United States are mounting. Because the virus does not present symptoms in many cases, it is possible that more people are infected – and may have donated blood after being bitten. The FDA has issued a warning that blood collections in the counties should not resume until they are able to properly test the blood and screen donors; they also recommend that neighboring and other at-risk counties consider taking the same actions.

Read NPR's article on it here.

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Sanders, Other Lawmakers Urge FDA Approval of Generic Crestor

Two months ago, AstraZeneca gained approval for the use of Crestor in children suffering from homozygous familial hypercholesterolemia (HoFH) and, under the Orphan Drug Act (ODA), the drug then qualified for extended market exclusivity for the treatment of this new condition. With the impending loss of patent protection for Crestor’s common use in adults, AstraZeneca has filed a lawsuit accusing the FDA of illegally interpreting a federal law that will allow generic medications to exclude indications for HoFH on their labels. Without the ruling, generic manufacturers would be required to include HoFH dosing and instructions on their labels, therefore violating the exclusivity granted by the ODA and extending AstraZeneca’s market hold. Bernie Sanders, along with several other lawmakers, are petitioning the FDA to approve the generics and offer a lower cost alternative to consumers.

Read the Stat News article on it here.

[Podcast from 2 Docs Talk] Direct-To-Consumer Marketing - Letting the Fox Guard The Henhouse

Summary: Direct-to-consumer drug marketing has, historically, been a controversial topic. In 2002, Merck spent $160 million on a marketing campaign for the new pain medication, Vioxx. Later, the drug was found to increase the risk of stroke and heart attacks and was being used, largely, by individuals who were well-suited for alternative drugs (like ibuprofen). In addition to the increased potential for misuse, many ad claims are misleading for consumers: A reported “significant” increase in length of life for patients on a treatment for lung cancer is actually three months. As pressure builds to regulate, or even halt, these advertising practices, the pharmaceutical industry has a proposed solution. They recommend giving the FDA approval rights for all prescription drug ads prior to their release, funded by manufacturers through a per ad ‘user fee.’ This approach is already used for drug approvals, with manufacturers funding over half of the FDA’s budget; prior to the implementation of these fees in 1993, drug company investment accounted for less than 10% of funds received by the FDA. Opponents of the measure are concerned how the impact of additional pharma industry funding will jeopardize the ultimate efficacy of the FDA’s practices.

Here the podcast from 2 Docs Talk here.

'Cross Protection' Occurs Between Bacterial Strains

Scientists recently discovered a mutually beneficial relationship occurring between bacterial strains: cross protection. In a new study, researchers grew two types of E. coli, each resistant to a different antibiotic, in the same test tube. The environment also contained the two antibiotics to which the strains were resistant. Instead of being eliminated, both bacteria deactivated “their” antibiotic, providing protection for the other strain. While not occurring in this study, experts suspect that, over time, this stable environment could lead to the exchange of resistance genes – making both strains of bacteria resistant to both antibiotics.

Listen to Scientific American's podcast about it here.

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GlaxoSmithKline CEO On Why Drugs Cost So Much

Sir Andrew Witty, the CEO of Britain’s GlaxoSmithKline (GSK), the sixth largest pharmaceutical company in the world, discusses the current period of ‘extreme challenge’ in the industry and acknowledges the disconnect between the global push for affordable healthcare and the current cost of needed medications. Specifically, he points to the U.S.’s lack of transparency requirements as a major driver for the issues that our country is facing today – an inability to determine the actual price of a drug makes it impossible to determine a realistic cost-benefit analysis for the system. Ultimately, he suggests, the system needs to balance cost, value and innovation to ensure shareholders remain invested and patients have access to the drugs they need.

Hear the podcast on it here.

New 'Scarier' Zika Warnings in the U.S.

The CDC recently released a broader range of Zika-related complications beyond microcephaly, including stillbirth, placenta damage, prematurity, etc., as well as potential links to additional non-pregnancy conditions. In this comprehensive discussion about the existing and anticipated impact of the virus, experts explain the developing understanding of transmission, effects and prevention. Although there is evidence that the disease is not in the continental US (beyond those that traveled to infected countries), experts estimate the range of the carrier mosquito to include parts of at least 30 states – with an additional potential carrier type extending as far north as Minnesota. Combined with the difficult of containment, due to the uniqueness of the mosquito (including breeding, biting habits, etc.), experts suspect that an outbreak in the United States would be the “public health version of [Hurricane] Katrina.”

Listen to the podcast about it from On Point with Tom Ashbrook.

Podcast: "How Wall Street Reacts When a Patient Dies in a Clinical Trial"

Summary

There exists an important link between scientifically proving a drug’s efficacy and safety and maintaining the confidence of investors who fund the clinical trials; one without the other likely means the drug will fail. When the drug company Zafgen entered the third stage of clinical trials for their drug, Beloranib (originally used to treat cancer, then tested for weight loss efficacy and, ultimately, the treatment of the rare Prader-Willi Syndrome which causes insatiable hunger in children), the death of two patients lead to investors pulling out and stock prices plummeting from $35/share to $7. Despite proof that both deaths were caused by a common condition to Prader-Willi patients not receiving treatment, investor confidence appears to be shaken and share prices have not returned to their original value. For small drug companies, like Zafgen, who do not have multiple high-dollar revenue streams or alternative, ongoing research opportunities, the results of a patient death (including long-term holds placed on future trials and subsequent loss of investor support) often mean the end of the business and the drugs for which patients throughout the country have been waiting.

Link to Podcast: https://www.statnews.com/2016/04/04/podcast-clinical-trial-death/

This Drug is Defying a Rare Form of Leukemia - And it Keeps Getting Pricier

Novartis introduced a breakthrough leukemia medication, Gleevec, 15 years ago with a list price of over $26,000 for a year; today, despite common market standards that expect competition to lead to price reduction, a year of Gleevec costs over $120,000. Unlike drugs sparking outrage with sudden, unexplained price increases, Novartis chose to gradually increase the cost of Gleevec on a year-over-year basis, oftentimes with the release of competitors to the market. The rarity of the form of leukemia treated by Gleevec was, according to Novartis, a partial explanation for the high cost; if more patients took the drug, they would be able to lower the cost and still recoup expenses. Today, Gleevec’s effectiveness has increased the population of individuals living with the cancer by 300% but Novartis’ original pricing explanation remains unseen. Novartis’ run with Gleevec has likely come to an end, though, as the drug lost patent protection last month.

Read the Washington Posts article about it here.

A Recent White House Budget Proposal Would Require More Transparency From Drug Makers

The White House budget proposal, released earlier this month, includes a requirement for pharmaceutical companies to disclose various business measures, including the cost of research and development; a requirement that would either prove or lay to rest to pharma’s continued argument that drug prices are directly related to their R&D costs. The measures mimic those proposed by states across the country and received similar backlash from industry lobbyists – including assertions that the requirement would stifle innovation, ignores R&D failures, and requires the disclosure of confidential information. That final argument is likely countered by an existing statute in the Affordable Care Act.

Read the coverage from Pharmalot's Ed Silverman here.

Study Finds that Some Drugs Approved for Other Uses Have Antibiotic Actions

As bacterial infections are becoming increasingly resistant to existing antibiotics, the University of Illinois has released promising research regarding the dual use of multiple drugs, including those used to treat parasitic infections and cancers. In fighting their intended diseases, many FDA-approved drugs also kill bacteria, work as uncouplers to destroy bacterial energy production and, in some cases, inhibit enzyme production and disrupt the cell membrane. Testing has primarily focused on the treatment of tuberculosis and staph infections. The researchers are also investigating tweaking the biology of certain drugs that are metabolized within the cell (eg. Heartburn drugs) to create an added level of uncoupling and, ultimately, cell death of bacteria.

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