In recent pharmaceutical news, a new cancer drug from Peregrine Pharmaceuticals, Inc. called Bavituximab has earned Fast Track designation by the US Food and Drug Administration, The Wall Street Journal reports.

“The FDA Fast Track Development Program is a designation of the United States Food and Drug Administration (FDA) that accelerates the approval of investigational new drugs undergoing clinical trials with the goal review time of 60 days. Such status is often given to agents that show promise in treating serious, life-threatening medical conditions for which no other drug either exists or works as well.” (Wikipedia)

Bavituximab is used in the treatment of “second-line non-small cell lung cancer (NSCLC)” and “represents a new approach to treating cancer.” (WSJ)

This drug works by targeting immunosuppressive molecules known as phosphatidylserine (PS).  While PS molecules are found inside healthy cells, in cancer cells they lie on the outer membrane “of cells that line tumor blood vessels”, and make for a relatively straightforward target for cancer drugs.  Bavituximab seeks out PS molecules and binds with them, thus suppressing their immunosuppressant quality, if you will, and allowing the immune system to attack the cancerous cells. (WSJ)

The research explaining the mechanism by which Bavituximab targets PS molecules appears in an October 2013 edition of Cancer Immunology Research, the peer-reviewed publication of the American Association for Cancer Research.

“Bavituximab is currently being evaluated in several solid tumor indications, including non-small cell lung cancer, breast cancer, liver cancer and rectal cancer with a trial in advanced melanoma anticipated to initiate in the near future.” (WSJ)

It is no secret that Americans pay some of the highest prices for pharmaceutical drugs in the world.  And, while the Affordable Care Act will help maybe 50 million uninsured Americans secure health insurance, that law will have no effect on the overall price of medication.

Soaring drug prices are likely the result of a variety of problems, such as inefficiencies in drug manufacturing and the high standard of research applied to each medication sold, but also result from simple price gouging and the tactics of trade groups such as PhRMA – a lobbying organization with an income of over $200 million in 2010.

This new bill, called “Personal Drug Importation Fairness Act of 2013,” proposed in the US House of Representatives and sponsored by Keith Ellison (D-MN), Jan Schakowsky (D-IL), and Dana Rohrabacher (R-CA), would allow individuals in the US to import drugs from “Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, and countries in the European Union, since these are believed to have safety standards comparable to the US”, reports Ed Silverman of Forbes.

And this isn’t, we should note, a new idea.  Already this past year, the state of Maine passed a law allowing its citizens to import drugs from internet pharmacies in the UK, Canada, Australia, and New Zealand.  Of course, this law received immediate push-back from PhRMA and other trade groups in lawsuits that alleged such laws circumvent FDA scrutiny and as such (are illegal and) place Americans at risk.

Ignoring the fact that it’s a little insulting to those countries – declaring that their drug safety standards are too low for American bodies, it seems that it might be a little more unhealthy for Americans to be starved of essential medications due to cost prohibition.

All of that is moot anyway, for in response to those allegations concerning the Maine law, the FDA claimed it will only allow the import of medications it has already approved.

Ed Silverman quotes the new bill’s Minnesota sponsor Keith Ellison as stating the bill will “‘allow Americans to spend more time focusing on their health and less time worrying about how they’ll pay for their prescriptions’”.

Of course, whether or not this bill will get off the ground has yet to be seen.  I hope it does.

According to a recent study, the results of which were summarized by HealthDay on MedlinePlus – a service of the US National Library of Medicine, keeping “bad” cholesterol levels under control may not only benefit the heart, but also the brain.

There are two kinds of cholesterol: HDL – “high density lipids” and LDL “low density lipids.”  In general, LDL is considered “bad,” for its loosely-packed structure further allows it to clog blood vessels.  Heart.org writes “When too much LDL (bad) cholesterol circulates in the blood, it can slowly build up in the inner walls of the arteries that feed the heart and brain. Together with other substances, it can form plaque, a thick, hard deposit that can narrow the arteries and make them less flexible. This condition is known as atherosclerosis. If a clot forms and blocks a narrowed artery, heart attack or stroke can result.”

High levels of “good” cholesterol, on the other hand, “seem to protect against heart attack.” “Medical experts think that HDL tends to carry cholesterol away from the arteries and back to the liver, where it’s passed from the body. Some experts believe that HDL removes excess cholesterol from arterial plaque, slowing its buildup.” (Heart.org)

The UC Davis study summarized by MedlinePlus fits well with what Heart.org writes: Bruce Reed, the study’s lead author states “Our study shows that “‘both higher levels of HDL and lower levels of LDL cholesterol in the bloodstream are associated with lower levels of amyloid plaque deposits in the brain’”.

A build-up of amyloid plaque in the brain “is an indication of Alzheimer’s disease.” (hyperlink added)

Reed states, “‘If modifying cholesterol levels in the brain early in life turns out to reduce amyloid deposits late in life, we could potentially make a significant difference in reducing the prevalence of Alzheimer’s, a goal of an enormous amount of research and drug-development effort’”.

While the researchers have yet to determine the precise mechanism by which cholesterol interacts with amyloid plaque deposits in the brain, for now we may conclude that we have yet another reason to keep LDL cholesterol levels in check.

A recent article published by HealthDay News on MedlinePlus, a service of the US National Library of Medicine, purports that “the expansion of Medicaid … could lead to more use of emergency departments instead of less”.

This article cites new research that found Oregon users of Medicaid, “the publicly funded health insurance program for the poor — are 40 percent more likely to use emergency rooms than people with no insurance.”

Amy Finkelstein, an MIT professor and an author of that study states, “‘When you cover the uninsured, emergency room use goes up by a large magnitude’” and remarks “‘In no case were we able to find any subpopulations, or type of conditions, for which Medicaid caused a significant decrease in emergency department use.’”

That study also found that it is common for Medicaid users to seek emergency room care for conditions that “might be more easily treated in a doctor’s office.”

Here are some of the issues: people using Medicaid often work several jobs and thus are not available to see primary care physicians during normal operating hours.  Next, a point made by Julie Rovner of NPR, citing the “director of state policy and programs for the National Association of Medicaid Directors,” Kathleen Nolan, is that “Because Medicaid recipients are by definition low income, Medicaid doesn’t use higher patient payments to deter emergency room use like many private insurers do”.

Rovner cites Nolan, stating “the key to getting inappropriate costs down for all patients, she says, is educating people about where they should go when it’s not an emergency.”  I agree.

One recent article by ProPublica, a prominent investigative journalism outlet, chronicles a lack of proper government oversight and coordination that “can expose Medicare recipients to potentially unsafe medical treatment and keeps tax dollars flowing to unworthy providers”.

The problem is this: some doctors who are terminated from Medicaid practice due to “inappropriate drug choices [that] endanger patients” and “unchecked devotion to name-brand drugs, instead of generics,” (a practice which unnecessarily bleeds the healthcare system of taxpayer dollars) are still allowed to prescribe drugs under Medicare Part D.

That is, doctors who have been deemed unfit to prescribe medication to certain patients remain allowed to do so for others.

To curb this, US Senator Charles Grassley (R-Iowa) “asked each state Medicaid program to explain its process for terminating doctors and notifying Medicare once it does so” and “sent a letter Friday to Marilyn Tavenner, administrator of the Centers for Medicare and Medicaid Services, asking what the agency is doing about such doctors.”

While this problem continues to exist, Jonathan Blum (Principal Deputy Administrator for Centers for Medicare and Medicaid Services) remains “committed to making improvements,” stating “‘We look forward to working with Congress and the HHS Inspector General to continue to protect beneficiaries and taxpayers from Medicare fraud, waste and abuse’”.

Hopefully, closing of loopholes such as this will bring down the total cost of healthcare moving forward.

According to a recent study, flu vaccines may be more effective in women than in men.

MedlinePlus, an online medical encyclopedia curated by the US National Institutes of Health and the National Library of Medicine made the following report:

“Researchers measured immune responses in 53 women and 34 men after they received their seasonal flu vaccination. The women produced a higher immune response in reaction to the vaccine. Testing was then done using different influenza strains and differences in gender-related immune responses were highest for the H3N2 strain.

The researchers say the gender differences are possibly due to a set of genes that may be regulated by testosterone. Men with the highest testosterone levels had the weakest antibody responses to the flu vaccine.

The CDC recommends that everyone who is at least 6 months of age should get a seasonal flu vaccine.” (hyperlinks added)

Follow this link to see a video explanation of these findings.  More to come as this story unfolds!

On August 21st, the US Food and Drug Administration issued a Class-1 recall for Siemens MicroScan Synergies plus® and MicroScan® rapID/S plus Negative Panels, affecting “78,020 panels distributed in the US between 07/11/2011 and 08/02/2013.” (FDA)

These panels come as part of kits used by medical professionals to test a patient’s saliva or tissue for microbial infection, and according to another FDA safety alert for Siemens MicroScan panels published September 4th, “using the MicroScan WalkAway System” may lead to a “false susceptible” reading or “false intermediate results for imipenem and meropenem antimicrobial susceptibility”. (emphasis added)

“This defect may lead to treatment with an inappropriate antibiotic or a delay in initiating appropriate therapy.”

These panels use new, innovative technology and are generally considered effective for determining a patient’s susceptibility to infection by some bacteria, but not others.  In 2002, medical researchers Caroline M. O’Hara and J. Michael Miller of the Centers for Disease Control and Prevention (Epidemiology and Laboratory Branch, Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia) published a paper titled  “Ability of the MicroScan Rapid Gram-Negative ID Type 3 Panel To Identify Nonenteric Glucose-Fermenting and Nonfermenting Gram-Negative Bacilli” in which they write, “With an accuracy approaching 75%, this product may be used for the identification of the commonly isolated non-Enterobacteriaceae bacteria but may present problems in identification of other non-glucose-fermenting gram-negative bacilli.”

If you were recently tested for a microbial infection by one of these bacteria, consider asking your doctor if he or she used a Siemens MicroScan Synergies plus® or MicroScan® rapID/S plus Negative Panels kit.  Using antibiotics when you don’t need them can compromise your immune system, which could be just as dangerous as a false negative reading or the use of the wrong antibiotic drug.

Recently, National Institutes of Health reports that it has possibly discovered certain genes that can be targeted for the treatment of Parkinson’s disease.  Parkinson’s is a disorder of the central nervous system (which includes the brain and brain stem).  Early signs of the disease are shaking and impaired movement, while later signs may include problems with thinking, dementia, and depression.  Parkinson’s is mostly found in people over the age of 50.

Richard Youle is an investigator at the National Institute of Neurological Disorders and Stroke and is quoted saying, “We discovered a network of genes that may regulate the disposal of dysfunctional mitochondria, opening the door to new drug targets for Parkinson’s disease and other disorders”.  It is thought that Parkinson’s is brought about by the accumulation of damaged mitochondria that are not recycled by the body.  By understanding which genes are responsible for triggering the removal of dysfunctional mitochondria, we can seek to repair those apparently nonfunctional genes and thus curb Parkinson’s.

Mitochondria are the powerhouses of the cells, using oxygen to convert chemical fuels into energy that the human body can use.  This chemical fuel is called Adenosine Triphosphate (ATP) and is used by the cells to carry out their individual functions.  Certain proteins that are found inside of cells are there to detect when mitochondria are not working properly.  Once these proteins find a dysfunctional mitochondria they tag it and the body dissolves the mitochondria.  This is a crucial part that needs to function properly in order for the body to get rid of the unwanted mitochondria.

With the development of new technologies we are now able to have a better understanding of how the mechanism of a disease works, and this insight can help scientists develop new treatments for many disorders that are devastating for afflicted individuals.

An article titled “California Firm Recalls Bolognese Sauce Products Due To Undeclared Allergen And Misbranding”, written by the United States Department of Agriculture’s Food Safety and Inspection Service, reports that the agency has forced the recall of 5,616 pounds of Armanino brand Bolognese sauce products.  The company did not properly label all of their products including milk as one of the ingredients found in the food.  This undeclared allergen could cause serious health problems for some people, and every product must be labeled with any and all known allergens it contains.

The products were sold in Hayward and San Francisco, California.  They did not have the USDA mark of inspection.  While there have been no reports of negative reactions from consumption of the mislabeled products, anyone who is concerned should contact their healthcare provider.

The Food Safety and Inspection Service has ways to check that their recall ability is effective,  making sure that recalling firms are performing their duties by notifying customers of the recall and ensuring that the product is no longer being sold.  The Food Safety and Inspection Service has a virtual representative that can be used 24 hours a day for any consumers who have questions or concerns.

A recent article by Bill Berkrot and Ransdell Pierson (published in Reuters) reports on restrictions being lifted from the use of the drug Avandia.  Avandia is a diabetes drug made by the company GlaxoSmithKline that was thought to increase the risk for heart attacks for people using the drug.  The U.S. Food and Drug Administration conducted an investigation into the safety of the drug and found there was not a significant increase in risk for heart attacks with Avandia, and their recommendation led health regulators to lift the restrictions of use for the drug.

Type I diabetes is an autoimmune disease that inhibits the body from properly controlling the amount of sugar in the blood.  Type I diabetics do not produce insulin, which acts like a key that allows sugar to enter the cells.  Cells gain energy from sugar, and will die without the proper supply.  Type II diabetes can come as a result of a poor diet and lack of exercise that causes the pancreas to form defective insulin molecules that do not adequately perform their function.  Both types of diabetes are serious medical conditions that can be fatal if not properly handled.

A 2007 report that claimed Avandia was dangerous prompted a halting of the distribution of the drug from Europe, and resulted in restrictions on the sale of the drug in the US.  The chemical name of Avandia is rosiglitazone had been one of the best selling medications for Glaxo, earning the company billions of dollars before rumors of the drugs dangerous characteristics came about.  Despite the fact that recent studies have shown there is no increased risk for heart attack while using Avandia, it is still assumed the drug will only be prescribed to patients who have tried other diabetes medications without success.  Only a small fraction of Americans continue to take Avandia since the restrictions were put in place.