Long-Term Birth Control Becoming Popular Among North Carolina, Colorado Teens

An article dated October 6th, 2016 discusses the use of long-term, reversible contraception among young women in North Carolina and Colorado. Long-term contraception is endorsed by multiple medical organizations, and experts say that it is 99% effective. Despite this, young women in the United States are more reluctant to use this form of birth control than are their peers in other developed nations. In North Carolina and Colorado, however, long-term contraception is gaining traction among young women and teens. Healthcare providers in North Carolina clinics underwent training to learn about long-term contraceptives, and Colorado has been subsidizing the cost of them. Due to their success in lowering teen pregnancy and abortion, the Department of Health and Human Services suggests that this form of contraception should become more accessible to potential users.

From npr.org, “Long-Term, Reversible Contraception Gains Traction with Young Women”

Excerpt from article:

By using effective contraception to space out their children, teens and other young women can help reduce the risk of delivering a premature or low-birth-weight baby, research shows. And preventing unplanned pregnancies can be ‘essential to a woman’s long-term physical and emotional well-being,’ according to HHS.”

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FDA Takes the Advocates’ Advice: Approves Drug from Muscular Dystrophy

In an article dated September 19, 2016, Muscular Dystrophy patients and advocates, with the help of select members of Congress, celebrated the FDA’s approval of Eteplirsen, a drug manufactured by Sarepta Therapeutics for treatment of a type of muscular dystrophy that predominantly affects boys in their childhood. Advocates fought heavily for the approval even though there are limited clinical trials to confirm the drug’s effectiveness. While the drug may help up to 12,000 Americans affected by the disease, critics worry that the FDA has set a “dangerous precedent” by its decision.

From NYTimes.com, “F.D.A. Approves Muscular Dystrophy Drug That Patients Lobbied For”

Excerpt from article:

[I]t was taken as a deeply troubling sign among drug policy experts who believe the F.D.A. has been far too influenced by patient advocates and drug companies, and has allowed the delicate balance in drug approvals to tilt toward speedy decisions based on preliminary data and away from more conclusive evidence of effectiveness and safety. . .

To read full article:   F.D.A. Approves Muscular Dystrophy Drug That Patients Lobbied For

 

 

Are Legal Limits for Marijuana Level Impairment Reliable?

The number of fatal car crashes involving marijuana use doubled in the state of Washington after the use of recreational marijuana was legalized.  One of the difficulties the state has encountered in preventing such crashes is determining per se limits for the amount of marijuana drivers can have in their systems.  Unlike alcohol impairment, which is defined by a blood alcohol content (BAC) level of .08 or higher, marijuana impairment is difficult to quantify. There is no reliable data showing that drivers become impaired at a specific level of marijuana content. Frequent users of marijuana, for example, may maintain higher levels of the drug for a longer period of time then occasional users. Thus, depending on the individual, drivers with relatively high levels of marijuana in their system might not be impaired, while others with low levels may be unsafe behind the wheel.  While there is no clear indication that a certain level of THC definitively increases the risk of car crashes, some states have implemented per se limits ranging from 1 ng/mL of THC to 5 ng/mL.

The AAA Foundation for Traffic Safety, however, is urging states to implement more comprehensive enforcement measures to improve road safety.  It suggests that, rather than relying on arbitrary legal limits, states should use a two-component system that requires (1) a positive test for recent marijuana use and, more importantly, (2) behavioral and physiological evidence of driving impairment. Marshall Doney, AAA’s President and CEO explained: “States need consistent, strong and fair enforcement measures to ensure that the increased use of marijuana does not impact road safety.”  But to maximize road safety, all motorists are advised to avoid driving while impaired regardless of whether the use of marijuana is legal in their state.

Source: https://www.sciencedaily.com/releases/2016/05/160510103131.htm

Legalization of Marijuana Reduces Teenage Use

According to the results of a biannual poll conducted by Colorado’s Department of Public Health and Environment, teenage marijuana use has not increased since the state legalized the use of recreational marijuana for adults over the age of 21. The poll surveyed about 17,000 high school students in Colorado, of which 21.2 percent responded that they used marijuana in the preceding thirty days. This is a slight decrease from the 2011 results of 22 percent. The 2015 survey also indicated that the nationwide average for teen marijuana use is slightly higher than Colorado’s at a rate of 21.7 percent. Yet, contrary to the results of Colorado’s survey, a survey by the U.S. Department of Health and Human Services placed Colorado at the top of the list of states which the highest rate of marijuana use in teenagers between the ages 12 to 17.

Advocates for legalization of marijuana believe that the results in Colorado’s survey prove that the “fears of widespread pot use by minors” in states with legalized cannabis are unwarranted. Yet, others are skeptical about the results. SMART Colorado, an organization that lobbies for stricter marijuana regulations, believes it is “‘deeply concerning” that according to the survey, only 48 percent of students in Colorado view regular marijuana use as a risky behavior.

Source: http://www.scientificamerican.com/article/colorado-s-teen-marijuana-usage-dips-after-legalization/

Ethical Questions Raised When Patients Engaged in Sales

A new phenomena is beginning to blur the ethical line between patient and sales representatives.  It involves drug companies using patients with a given disease, most commonly hemophilia, to induce others with the same disease to buy certain medicines. This blurs the line between patient and salesperson, without disclosing the potential conflict of interest. Pharmaceutical companies believe that by hiring patients with a particular disease to sell a company product to others with the same disease, the company improves services by having someone who understands the patient from their own perspective. But if you ask some people, such a tactic simply seems mercenary.

On the one hand, only a patient who is taking a certain treatment can truly advise another patient about their experiences with that treatment. On the other hand, some patients have stopped attending support group meetings because they are having difficulty distinguishing between sales pitches and genuine patient experiences because of the growing use of patient representatives by pharmaceutical companies.  This is more disturbing still in that the benefit to the patient representative is rarely disclosed.  Some in the pharmaceutical industry have been prosecuted for taking patients out to dinner or buying them presents to solicit their business. In the past, this was a very common practice. However, drug companies and pharmacies are no longer allowed to do this; so, they seem to have moved on to the tactic addressed in the article herein summarized. Pharmaceutical companies are inserting themselves into a tightknit community of people with a particular disease and blurring the line between ethics and business practices.

Source: http://www.nytimes.com/2016/01/14/business/hemophilia-patient-or-drug-seller-dual-role-creates-ethical-quandary.html?_r=0

Pharma Cash Cow: Old Medications, Lucrative Opportunities

In August of this year, the rights to the decades old drug Daraprim were purchased by pharmaceutical company Turing Pharmaceuticals.  Daraprim is the standard of care for treating toxoplasmosis and is used as well in treating HIV infections, cancers, and malaria.  Although the drug was previously sold at $13.50 per tablet, upon its purchase by Turing Pharmaceuticals, the drug’s price increased by over 5,000% to $750.00 per tablet, sparking mass outrage across the internet.

The CEO of Turner Pharmaceuticals, Martin Shkreli, a former hedge fund manager, responded to the widespread criticism of the price increase by providing several reasons for the pricing structure change.  In particular, Mr. Shkreli cited the need to keep the company’s manufacturing costs competitive and to raise capital for the development of new medications to treat toxoplasmosis.  However, medical professionals indicate that there is no need to develop new pharmaceuticals to treat toxoplasmosis and that the former price was profitable, albeit at a much smaller margin.

In response to the public outcry against the price hike, which included criticisms from former Secretary of State Hillary Clinton and presidential candidate and Vermont Senator Bernie Sanders, Turing Pharmaceuticals has reversed the price increase. However, Turing Pharmaceuticals is not the only pharmaceutical company to acquire an old medication and subsequently increase its price to boost profits.  Other drugs, such as Sovaldi, used to treat hepatitis C; Harvoni, a follow-on formulation of Sovaldi for hepatitis C; Retrophin, used to reduce kidney stones; and Cycloserine, used to treat drug-resistant tuberculosis, have also been subjected to similar price increases. Congress is poised to inspect the recent trend in drug price increases, but until congressional action is taken, it appears public outcry will be the primary means of keeping more excessive increases at bay.

To read more about, this click on any of the following links:  LA Times, NBC, NBC News, CBS News

Marijuana Extract: Miracle Drug for Children With Epilepsy?

Researchers have been studying the effects of Cannabidiol (“CBD”), a marijuana extract claimed by some to be a “wonder drug” for treating children who suffer from severe epilepsy.  CBD, which has also been used in to treat many different conditions including schizophrenia and anxiety, has been legalized in many states and others are considering legislation.

Early research of CBD has revealed mixed results. For example, Dr. Kevin Chapman, a neurologist at Children’s Hospital Colorado conducted a study of 75 children treated with CBD. He found a drop in seizures by at least half in 33% of the children.  But, also found that 44% of the children had a negative response that included an increase in seizures.

However, GW Pharmaceuticals (“GW”) conducted a study focused on a “purified CBD extract” known as Epidolex as part of their program to treat resistant childhood epilepsies. The study revealed that of 58 participants, 40% had a decline in seizures, 10% of which became completely seizure-free, while one patient had an increase in seizures. (read more about Epidiolex and GW Pharmaceuticals follow the link http://www.wsj.com/articles/PR-CO-20150108-905340)

Source

http://www.wsj.com/articles/marijuana-extract-for-children-with-epilepsy-is-questioned-1427148386

FDA Approves Cheaper Version of Popular Drug Prescribed for Chemotherapy Patients

In early March 2015, the Food and Drug Administration (“FDA”) approved Zarxio, the first “biosimilar” drug, to be introduced into the U.S. market. Biosimilars are expected to offer cheaper versions of existing biologics. They are nearly identical to the originals, and are used to treat the same conditions. Biosimilar drugs are expected to create a more competitive market by providing people with comparable, less expensive prescription medication.

Zarxio, the first of what is likely to be many biosimilar drugs to receive FDA approval, will compete with Neupogen, a drug prescribed to chemotherapy patients. Zarxio promises to be cheaper than Neupogen and similar enough to serve all five of Neupogen’s current uses.  However, questions remain as to how effective biosimilars will be in lowering the cost of drugs. In fact, the makers of Zarxio have not announced how much cheaper the drug will be.  Secondly, there is no telling whether clinicians will embrace biosimilars.

Amgen, the makers of Neupogen, asked a California federal judge for an injunction blocking the launch of Zarxio.  They allege that the makers of Zarxio failed to follow the rules in seeking regulatory approval.   A court hearing is set for March 13, and Novartis, the maker of Zarxio, has agreed not to sell Zarxio until the hearing or April 10, whichever is earlier.

http://www.wsj.com/articles/fda-approves-first-biosimilar-drug-1425651840

Lawsuits Accuse Drug Companies of Pushing Pain Meds.

Five drug companies are under fire for allegedly participating in “aggressive marketing” of prescription opioids. The City of Chicago and two California counties have filed two separate lawsuits blaming the drug companies for aggravating the opioid addiction epidemic in the United States. Among other allegations, the lawsuits claim that patient information groups received millions of dollars from the drug companies and, in return, the information groups played down the risks of the drugs. The City of Chicago claims the drug companies gave the American Pain Foundation $10 million and then the Foundation promotes messages such as, “opioids are rarely addictive when used properly for the management of chronic pain.” Similar lawsuits were successful against the tobacco industry in the 1990’s, leading to heavier restrictions on tobacco products.

Read more here.

Cell Mutation Protects Against Heart Attacks

Two independent studies have published findings identifying mutations in a single cell that can prevent heart attacks. This mutation keeps triglycerides very low throughout a person’s lifetime, which in turn protects against heart attacks.

These findings will likely push the development of drugs that mimic the effects of the mutation, resulting in the first new class of drugs aimed at lowering the risk of heart disease since Statins were introduced in the 1980’s.

 Read more here.