Federal regulators may finally step in an take a real stance against the pharmaceutical industry’s rampant price-gouging.

Pharmaceutical companies have been notoriously price-gouging. The recent scandal centered around the ridiculously inflated cost of Daraprim showed how carelessly pricing is regulated.

Many have been left wondering if federal lawmakers will take action against the high price of life-preserving medications.

Putting Price-Gouging In the Spotlight

Pharmaceutical companies have created a pattern of acquiring the rights to certain drugs and then raising the cost.
Image: Buzzsaw Mag

Drug prices have been steadily increasing throughout the past decade. The first big hit was when Gilead Sciences priced the hepatitis C treatment Sovaldi at $84,000.

The high price of prescription medication received a renewed wave of attention when Turing Pharmaceuticals raised the price of Daraprim, an antiparasitic drug that protects seriously ill patients with weakened immune systems.  CEO Martin Shkreli made the decision to raise the toxoplasmosis treatment from $13.50 to $750 a pill.

Although he rescinded his original announcement, media broadcasters publicized widespread outrage from politicians, health professionals and patients.

Canadian drugmaker Valeant Pharmaceuticals International added fuel to the fire by raising the price of two heart medications, Nitropress and Isuprel, by 525% and 212% respectively. Many of these companies have started a pattern of acquiring the rights to sell a certain drug before raising the price a few hundred times.

On top of that, Citron Research accused Valeant of conspiring with specialty pharmacies Philidor Rx Services and R&O Pharmacy in a plan to generate phony sales.

The report sheds light on a stark jump in drug costs for both new breakthrough medications and older generics.

How To Combat The Increase

Patients protest Congress to fight Big Pharma’s standard of high pricing.
Image: US News

John Rother, CEO of the National Coalition on Health Care, has been working on a campaign to lower drug prices.

After the high price of Sovaldi and others brought attention to price-gouging, many politicians have begun to highlight the problem in their political campaigns.

“For lawmakers who are concerned about our fiscal standing, this is going to be an ever-more central issue,” Rother said.

According to a Health Affairs article, drug costs had increased 12.6% in 2014. While some are calling on regulators to step in, others believe that government interventions could have additional consequences.

“I’m very worried that on the pricing side, policymakers could be clumsy in trying to fix something and maybe make other problems,” Chip Kahn, Federation of American Hospitals CEO, said.

Both Democrats and Republicans have planned to address the issue in their platforms. Presidential candidates Hillary Rodham Clinton, Bernie Sanders and Marco Rubio are condemning the current system that allows drug companies to set their own prices.

Under Sanders and Clinton’s health care reform, Medicare would be given the ability to negotiate with drug companies to set prices. Patients would also be allowed to access to cheaper drugs from foreign providers.

Independent Health’s director of pharmacy services Sheila Arquette believes regulators will take action upon realizing that the current price of drugs makes health maintenance unsustainable.

Arquette recommends that drugmakers and insurers work together to find solutions, in addition to being more transparent about research and development costs.

“We have to be transparent, because I don’t think any of us really understand the whole picture,” Arquette said. “We need the manufacturers to come to the table and just be honest with us.”

The post Will Federal Regulators Take Action Against Pharmaceutical Price-Gouging? appeared first on Citizens Report.

The Obama administration has agreed to fund a heroin overdose reversal agent as part of a nationwide program to curb drug-related deaths.

Heroin-related deaths in the U.S. have nearly doubled between 2011 and 2013. In 2013, the number of people who died from overdose rose to 8,200.

The Obama Administration is taking action to combat the issue by expanding access to a drug that can stop a heroin overdose. The life-saving opioid antagonist, called Naloxone, will be available without a prescription in more than 30 states.

Reversing A Heroin Overdose

The goal of educating non-medical personnel about how to use Naloxone is to prevent overdoses outside of the hospital setting. 
Image: Heroin Addiction

Naloxone, which has a 90 percent success rate if consumed in time, reverses the effects of narcotic drugs. While doctors may use it when pain management complications from surgery arise, it is particularly effective in combating an opiate overdose.

Naloxone can be administered intravenously or through the nasal passage. It blocks the effects of extreme drowsiness, slowed breathing or loss of consciousness.

It counteracts central nervous system depression and allows the respiratory system to work, helping the overdose victim to breathe. The medication has no effect on a person who does not have opioids in their system and therefore, has no potential for abuse.

The Obama Administration’s Plan

Naloxone is also known by the brand name Narcan.
Image: ACE Surgical

The Obama administration launched private and public programs to address opioid and heroin addiction. The programs focus on prescription drug abuse, in addition to issues with substances sold on the street. The program includes a variety of initiatives, including but not limited to:

• Over-the-counter access: CVS Pharmacy will expand its 1-month-old program selling naloxone to patients without a prescription from locations in 12 states to 32 states in 2016.
•  Funding for low-income communities: The Department of Health and Human Services has given $1.8 million to lower socioeconomic classes to purchase naloxone and train first responders on how to use it.
• Native American populations: The Bureau of Indian Affairs (BIA) and the Indian Health Service will provide BIA police officers and investigators with the naloxone.
• Police education: The Fraternal Order of Police will educate 330,000 members about identifying and treating opioid overdoses. The International Association of Chiefs of Police will educate law enforcement on how to prevent overdoses. City and state police officers will begin to require police officers to add naloxone to their everyday toolkit.

In August, the administration announced a $2.5 million strategy to combat the public problem of heroin abuse. Deeming it a health issue instead of a criminal justice problem, political parties on both ends of the spectrum have moved to support increased access to Naloxone.

Obama visited Charleston, West Virginia to unveil the programs. The state is particularly affected by addiction with an overdose rate of more than twice the national average.

Critics argue that the policy is vague and that the education initiatives are hard to implement. Regardless, the program will provide widespread access by doubling the number of doctors who can prescribe naloxone.

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Homeopathic remedies are controversial, and it’s important to evaluate characteristics that differentiate these natural medicines from traditional scientific treatments.

Homeopathic remedies are becoming increasingly popular in both conventional pharmacies and specialty drugstores.

While some praise natural medicines as the purest kind of cure, others claim that science-based treatments are the only proven form of medicine.

The Basic Differences

Homeopathic medicines aren’t evaluated by the FDA for safety and effectiveness.
Image: Allergies and Your Gut

One of the biggest differences between homeopathic remedies and prescription drugs is FDA approval. The FDA is charged with evaluating the safety and effectiveness of each drug that enters into the conventional medical market.

Homeopathy encompasses ancient practices that are based on the idea that like cures like. On example is Allium cepa (red onion), which is used to treat allergies. Red onion causes irritated eyes and a runny nose, which makes it a possible remedy for these symptoms in the homeopathic school of thought.

The active ingredient in homeopathic medicine is often diluted. The technique is to dilute the ingredient as much as possible to gain the most benefit.

Some critics argue that diluting an active ingredient would make the treatment less potent, which means it would be less likely to work. These kinds of natural remedies don’t conform to scientific norms, making them highly controversial.

A Look At The Ingredients

Active ingredients in homeopathic medicines are often diluted.
Image: The Telegraph

The active ingredient in homeopathic remedies often comes from natural sources such as plants and animals. The derivatives are then mixed with lactose or sugar pills, topical creams or inhalable liquids. These ingredients can often be bizarre, including additives like snake venom, arsenic or even heavy metals.

Sometimes these ingredients can be dangerous to consumers.

In March 2014, holistic healthcare manufacturer Terra-Medica recalled 1,768 products of six homeopathic medications made by the firm Pleo Sanum after the FDA found that some variations might have contained the antibiotic penicillin.

These recalls are not entirely uncommon. In 2010, the FDA cautioned against using Hyland’s Teething Tablets. The pills may have possessed derivatives of the deadly nightshade plant. Also known as belladonna, deadly nightshade causes rapid heartbeat, fever and difficulty urinating.

Studying the Effectiveness of Homeopathy

Many scientists argue that homeopathy is no better at treating illness than placebos.
Image: Platform 505

Because natural medicines contain diluted active ingredients, health professionals have argued that these treatments work no better than placebos. The National Health and Medical Research Council reviewed 176 studies of homeopathic medicine and concluded that this hypothesis was true.

It argued that “there are no health conditions for which there is reliable evidence that homeopathy is effective.”

“Some trials done 20 years ago seemed promising,” said Adriane Fugh-Berman, M.D., an expert in botanical medicine and an associate professor of pharmacology at the Georgetown University Medical Center in Washington, D.C. However, newer experiments have found that homeopathy isn’t as effective as originally thought.

Regulating Homeopathic Medicines

The labeling and advertising of homeopathic medicines are not subject to FDA scrutiny.
Image: Homeo Labels

Homeopathics are classified by the FDA as drugs, which means the labeling should disclose ingredients, provide detailed instructions and signify medical conditions that the product is meant to treat.  If the medication is made to treat a condition like cancer, it is necessary to get a prescription for the drug.

There is one big difference between prescriptions, over-the-counter drugs and homeopathic remedies. Homeopathics are not required to go through an FDA review that would evaluate the safety and effectiveness of each drug. These drugs are loosely regulated and lack a proven body of results.

Makers of homeopathic medications don’t have to provide evidence that homeopathic drugs work.  The only requirement is for the products to include ingredients listed in a database called the Homeopathic Pharmacopoeia of the United States, which is managed by the nongovernmental Homeopathic Pharmacopoeia Convention of the United States.

But as more people purchase these alternative remedies, the FDA is prompted to pay more attention. The regulatory body is leaning towards evaluating homeopathic products while the Federal Trade Commission would monitor false and misleading advertising.

Regardless of the many critics, natural medicine is more popular than ever. According to the Nutrition Business Journal, Americans spent $1.2 billion on homeopathic drugs in 2014. The figure has grown 33 percent since 2000.

The post Evaluating Homeopathic Cures appeared first on Citizens Report.

After reevaluating a study that was more than a decade old, researchers discovered the original data backing the use of the antidepressant Paxil in young people was incorrect.

The reanalysis of the 2001 study that led regulators to believe Paxil should be approved for youth has proven the antidepressant is not actually safe and effective for teenagers.

Critics of the original study are using the error to promote a widespread revamping of scientific self-examination and peer reanalysis.

The Study Revisited

It was later discovered by researchers that Paxil is dangerous for teens and young adults suffering from depression.
Image: Share Care

Dr. Martin Keller of Brown University spearheaded the original study, which included three groups of 90 adolescents throughout eight weeks. One group took Paxil, another took a  placebo and the third group took imipramine, which is an older generic drug for depression.

The group taking Paxil did not outdo the other groups in a standard depression questionnaire, but the drug proved to be more successful in “secondary” measures. Managing certain scales of mood problems was one of the successful areas, the authors reported.

The study was published in the Journal of the American Academy of Child and Adolescent Psychiatry, but many believed that it was unconvincing. Critics who disapproved of the study results said that serious side effects had been played down.

Drug manufacturers began testing antidepressants in young people in the 1990s. These trials are difficult because an estimated one-third of participants is likely to improve on their own. Measuring improvement and labeling side effects are tricky, as each word can play into the perception of a drug.

The 2001 study is part of a long-standing dispute between researchers testing the safety of antidepressants for teens and young adults. In the 2000s, the antidepressant wars subsided with warning labels of Paxil and drugs in its class. The labels included a potential risk of suicide risk for children, adolescents and young adults. However, these drugs are considered safer and more effective for many adults over 25 who have been diagnosed with depression.

The study is still supported by the drug manufacturer GlaxoSmithKline. The drug’s manufacturer submitted the results to federal regulators, who decided that Paxil was going to be approved for use in adolescents.

The manufacturer acted based on scientific conclusions made at the time but is working to incorporate data from the new analysis into the regulation of the drug.

GlaxoSmithKline willingly allowed researchers to access the data, claiming they have engaged in “an unprecedented level of data sharing that speaks to our absolute commitment to transparency.”

Longtime critics of the original study played a role in reanalyzing the data, which took almost a year to complete. The researchers reread summaries, internal trial reports and patient-level data, which included detailed descriptions of how each patient responded to original trials.

In the fourteen years after the study was released, Paxil and other antidepressants have been associated with violence and suicide. But there are no clear statistics depicting this trend.

It is unclear what factors, in conjunction with psychiatric drugs, caused violent reactions, so it’s difficult for health professionals to determine who is at risk.

Dr. Keller and his co-authors disagree with the reassessment of the original study, saying that, “In summary, to describe our trial as ‘misreported’ is pejorative and wrong.”

A New Era Of Reanalysis

The discovery has prompted a discussion on a new trend in scientific publishing that would allow for multiple interpretations in one journal. 
Image: Neusentis

The study led to a surge in antidepressants prescribed to adolescents, increasing by 36 percent between 2002 and 2003. It slowed when regulators added black-box warnings to labels.

By reanalyzing a study that is more than a decade old, scientists are starting a new trend that could yield greater scientific confirmations and ease for patients. Experts cite a new era of scientific publishing, which would allow journals to post additional interpretations of the same study.

Scientific self-examination is becoming more common. Retractions are occurring more frequently than ever before, and fraud has shown just how important it is to replicate results. In fact, when researchers analyzed a sample of psychology papers, only half were correct. This means that reexamination is more important than ever.

The authors of the renewed study illustrate that the errors which occurred in the Paxil study are popping up in other areas of research. Their goal is to make the reanalysis available to scientists in clinical medicine to allow for additional perspectives on the results.

The post Study Reanalysis Shows Antidepressant Is Harmful For Teens appeared first on Citizens Report.

Japanese pharmaceutical giant Takeda is attempting to settle thousands of bladder cancer lawsuits. The company refuses to go through with payouts until 95 percent of plaintiffs sign on, but many are holding out in hopes of getting more compensation.

A $2.37 billion dollar deal to settle thousands of lawsuits related to Takeda’s cancer-causing diabetes drug Actos is in the works. But the settlement may not make it to the final stages if claimants continue to hold out for higher payouts.

Takeda Pharmaceutical Co.’s new CEO Christopher Weber made the $2.37 billion offer in hopes that enough claimants would sign on to close the case. But 20 percent of the desired 95 percent of claimants didn’t agreed to the deal by the initial deadline, which has sprouted doubts about the settlement, causing many to question if it will fall through.

The Backstory on Actos

Actos is a popular Japanese-made diabetes drug that has been linked to bladder cancer.
Via: Japan Times

Takeda Pharmaceutical Co. is a Japanese pharmaceutical company and one of the largest pharmaceutical manufacturers in Asia. Takeda’s diabetes drug pioglitazone, known as Actos, was released in 1999. The drug has since generated more than $16 billion in sales.

In 2004, Actos conducted studies that linked the drug to bladder cancer. The company reportedly kept these findings a secret for seven years.

In 2011, Actos revenue was at an all-time high, ranking in at $4.5 billion. The drug generated 27 percent of Takeda’s income at the time, according to Bloomberg.

Takeda came finally forward about the studies, and the FDA issued an Actos FDA Bladder Cancer Warning on June 15, 2011.

Actos has reportedly caused cancer in thousands of patients, subjecting Takeda to five years of litigation. Takeda teamed up with Eli Lilly in marking efforts, which has made the pharmaceutical company partially liable in the settlement.

In addition to thousands of lawsuits, the FDA has ordered Takeda to obtain data on drug dose, duration of exposure and potential confounding factors that cause cancer. The study will include 193,099 patients with diabetes who do not already have bladder cancer.

“To address the long-term risk of bladder cancer associated with pioglitazone use, the drug manufacturer (Takeda) is conducting a ten-year, observational cohort study as well as a nested case-control study in patients with diabetes who are members of Kaiser Permanente Northern California (KPNC) health plan,” according to the FDA Bladder Cancer Warning.

“The FDA will continue to evaluate data received from the ongoing KPNC study. The Agency will also conduct a comprehensive review of the results from the French epidemiological study. FDA will update the public when additional information becomes available.”

Holding Out For Higher Payouts And Higher Acceptance Rates

Takeda’s lawyers are confident that 95 percent of plaintiffs will sign on by the extended deadline, which ends on September 11.
Via: 2heads

The average payout to each individual who developed cancer or another illness from taking Actos would be more than $250,000. The deadline for 95 percent of claimants to sign on and accept the settlement terms was August 12, but it passed with only 75 percent of plaintiffs on board.

Experts speculate that many of the individuals who developed cancer are aware of higher payouts awarded in previous trials, which has made the plaintiffs more likely to hold out on the deal.

Takeda is on a losing streak when these cases are taken to trial, with five loses out of nine. In Louisiana, a jury awarded $9 billion to a patient who reportedly developed bladder cancer after using Actos for 5 years. The award was reduced by 99 percent to $36.8 million in 2013, but that is still exponentially higher than what plaintiffs would receive in the settlement.

For this reason, some may be in favor of taking their chances suing Takeda. Others might refuse to settle on principle.

Either way, the deadline has been extended for an additional month and will be closed on September 11. The company is holding out on finalizing the deal until almost everyone is in agreement. Takeda’s lawyers appear to be confident that plaintiffs will sign on before the next deadline hits.

“The rate of participation in the resolution program at this point in the opt-in process is in line with other similar, successful resolution programs,” according to Kenneth Greisman, a lawyer representing Takeda.

In the meantime, jurors are being appointed to a trial in Las Vegas State Court. Cases are still pending in federal courts in Lafayette and Louisiana, and in state courts in Illinois, West Virginia, California and Pennsylvania.

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