In this case, a 20-year-old woman from Texas is suing the company for her own birth defects. The age of the plaintiff shows that Zofran has been prescribed to pregnant women for over two decades.

Using Zofran To Treat A Mother’s Morning Sickness

The plaintiff’s mother took Zofran to treat her severe morning sickness.
Image: The Pregnancy Zone

While pregnant, the woman’s mother dealt with a condition known as hyperemesis gravidarum. It’s a serious form of morning sickness characterized by excessive vomiting and intense nausea. During the first trimester, doctors prescribed Zofran to treat the debilitating symptoms.

Today, the 20-year-old woman suffers from congenital heart defects. She was born with a ventricular septal heart defect and pulmonary stenosis. She also has facial defects, such as cleft lip and cleft palate.

In the complaint, the woman argues that she has no genetic predisposition to cardiac or facial defects. She believes that Zofran exposure caused her defects and forever altered the quality of her life.

Filing A Suit For Compensation

The plaintiff was born with facial defects that require costly medical procedures.
Image: I Am Pregnant

On Nov. 30, 2015, the woman filed a lawsuit with the Northern District of California court system. She’s suing for negligence, fraud, misrepresentation and warranty breach.

The lawsuit alleges that GlaxoSmithKline discovered that Zofran might increase the risk of birth defects in 1992. But according to the complaint, the company didn’t take action and inform doctors of the risk.

GlaxoSmithKline engaged in off-label marketing of the anti-nausea drug, which the FDA approved for cancer patients only. The pharmaceutical company never did clinical studies before pushing the drug but reportedly knew that pre-natal Zofran exposure could injure unborn children.

Throughout her life, the 20-year-old woman had at least three surgeries. Doctors predict that she will need to undergo additional medical procedures for the remainder of her life. She’s suffered from permanent disfigurement, diminished quality of life, low self-esteem and physical and mental pain.

The woman seeks $75, 000 in compensation that would help to cover her medical bills. The award would also reimburse her for the purchase price of Zofran, and general, consequential and punitive damages.

If you or a family member was born with birth defects, then you might be entitled to compensation for this medical side effect.

Complete a free, no-obligation case evaluation now to see if you qualify.

The post Young Woman Files Against Zofran For Her Own Birth Defects appeared first on Citizens Report.

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.

A new study rethinks the treatment of schizophrenia and proves that patients would benefit from fewer antipsychotics.

Schizophrenia is a mental health disease that affects more than two million people in the United States alone. The condition is often treated with heavy, dazing antipsychotic drugs.

The medication stops the symptoms of schizophrenia but leaves patients with a slew of side effects, such as severe weight gain or debilitating tremors.

A new federally-funded study calls for a different way to treat schizophrenia, focusing on providing less medication and more options for therapy.

The Study

Researchers found that talk therapy benefited patients who were experiencing the first schizophrenic episode.
Image: The Daily Beast

The research was published in the American Journal of Psychiatry after a series of in-depth trials. The study suggests that patients who took small doses of antipsychotics combined with one-on-one talk therapy and family support saw better results than those who were overprescribed and sedated.

Funded by the National Institute of Mental Health, the study found that patients who received active therapy after the first schizophrenic episode did much better in recovery.

“I’m very favorably impressed they were able to pull this study off so successfully, and it clearly shows the importance of early intervention,” said Dr. William T. Carpenter, a professor of psychiatry at the University of Maryland School of Medicine.

The study is based on successful programs that have been used in Australia and Scandinavia for decades. This is the first real-world trial of this method.

The study was conducted at 34 community mental health centers in 21 states randomly assigned either drugs, therapeutic treatment or both. It included 404 people with first-episode psychosis in their late teens or 20s, half of which received the new approach. The other half of patients received antipsychotic care.

The patients were monitored with standardized checklists that rate symptom severity and quality of life, taking into account the ability to work and get along with family. Patients in the combined program had more symptom relief and functioned better.

The medicated group experienced side effects including weight gain, extreme drowsiness or emotional numbing. Studies show that three-quarters of people prescribed antipsychotics stop taking them within a year and a half.

“As for medications, I have had every side effect out there, from chills and shakes to lockjaw and lactation,” said a 20-year-old trial participant named Maggie. Maggie benefited from the newer approach and is now attending nursing school.

Medications were still used during treatments, but doses were kept at a minimum to keep side effects at bay. The therapy package included help with work and school decisions and increased education for family members. The final component is one-on-one talk therapy, in which the doctors help the patient build social relationships, reduce substance use and manage the symptoms.

“One way to think about it is, if you look at the people who did the best — those we caught earliest after their first episode — their improvement by the end was easily noticeable by friends and family,” Dr. Kane said.

A Change In Mental Health Reform

Regulators are attempting to provide funding for combined-treatment programs that employ active therapy and low doses of medication.
Image: Huffington Post

Mass shootings related to mental illness continue to increase, and Congress is currently deciding on reforms that will help combat episodic violence.

In its guidelines, the Centers for Medicare & Medicaid Services strongly agreed with the combined therapy approach. The reform bills now “mention the study by name,” said Dr. Robert K. Heinssen, the director of services and intervention research at the National Institute of Mental Health.

Congress awarded $25 million to states to fund early intervention mental health programs in 2014. Dr. Heinssen told the New York Times that 32 states have begun using those grants to fund combined-treatment services.

Critics believe that the current methods used to treat schizophrenia are ineffective, especially in the onset of psychosis. The early stages of the disease usually occur in the late teens or early 20s. The hope is that the study will set a new standard for care.

Dr. Kenneth Duckworth, medical director for the National Alliance on Mental Illness, an advocacy group, said the study was “a game-changer for the field” because it chooses a therapeutic method based on the stage of the disease.

The post New Approach To Treating Schizophrenia Suggests Fewer Prescriptions appeared first on Citizens Report.

The Trans-Pacific Partnership Agreement protects the exclusivity of biologic medicine in international markets, but Big Pharma isn’t satisfied with the details of the deal.

The Trans-Pacific Partnership Agreement, which deals with intellectual protection for certain drugs, is extremely controversial.

The agreement between the U.S. and 11 other countries will soon be up for debate in Congress. However, the current plan doesn’t satisfy pharmaceutical companies or consumers.

The Stipulations Of The Deal

The trade deal won’t change data exclusivity in the U.S., but would instead apply protections to drugs sold in partner countries like Australia, Brunei, Vietnam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru and Singapore.
Image: Activist Post

Under the agreement, countries must protect data for biologic medicines. Biologic medicines, produced by living cells, would be protected abroad for a minimum of five to eight years.

Big Pharma was hoping for at least 12 years of protection while consumer groups wanted to keep minimum exclusivity.

The rule would give certain companies a monopoly on drugs and prohibit others from creating biosimilars for a pre-decided period of time. Similar drugs cannot enter the market with clinical trial data from the original drug.

Currently, U.S. federal law gives biologics data exclusivity for 12 years. The trade deal won’t change that at home, but instead apply exclusivity to partner countries like Australia, Brunei, Vietnam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru and Singapore.

Many countries don’t implement data exclusivity. The agreement would require that these countries create laws that would give certain companies a monopoly for five years. 

“In the U.S., I don’t think there would be that much that would need to change,” said Joy Liu, a partner at Ropes and Gray who advises drug and biotech companies on FDA-related matters.

Domestic pharmaceutical companies who invested in the research and development of drugs abroad would be affected by competition in foreign markets, which is the reason why the industry has called for data protection. 

“PhRMA believes that strong intellectual property protection is necessary for the discovery and development of new treatments and therapies for the world’s patients,” said John Castellani, CEO of industry group the Pharmaceutical Research and Manufacturers of America, in a statement.

Castellani believes that biologic medicines are “next wave of innovation in our industry.”

“While we await final details, it appears that the Ministers missed the opportunity to encourage innovation that will lead to more important, life-saving medicines that would improve patients’ lives,” Castellani said.

Criticisms Far And Wide

Critics argue that the deal allows companies to extend monopolies overseas.
Image: Minneapolis Fed

Many critics believe that the deal is about concentrating power, not ensuring fair trade.

Peter Maybarduk, director of consumer advocacy group Public Citizen’s Access to Medicines Program, said the deal still allows companies to stop biosimilars from entering the market. 

“The problem of drug pricing is increasingly out of control in the U.S. and everywhere,” Maybarduk said. “Of course we need to pay for medical innovation, but there are more efficient ways to do that than monopolies.”

Doctors Without Borders also disagreed with the deal. 

“Although the text has improved over the initial demands, the [trade agreement] will still go down in history as the worst trade agreement for access to medicines in developing countries, which will be forced to change their laws to incorporate abusive intellectual property protections for pharmaceutical companies,” said Judit Rius Sanjuan, legal policy adviser to the group’s access campaign, in a statement.

Biologics are given patents that could make data exclusivity unnecessary. While patent laws prohibit biosimilars from joining the market for a certain time period, the pharmaceutical industry criticized them as weak in comparison to traditional drugs, said Arti Rai, a law professor at Duke University.

Waiting On Congress

Congress must approve or reject the deal without amending it.
Image: The Real Daily

Congress had previously agreed to fast track the agreement, but it’s not clear if Congress will agree to the deal now. The regulatory body must approve it or throw it out without amending it.

The Senate Finance Committee won’t approve the agreement unless the intellectual property right laws of U.S. trade partners are created and expanded.

The chair of the committee, Sen. Orrin Hatch (R-Utah), fully expects the Trans-Pacific Partnership agreement to include 12 years of regulatory data protection for biologics.

However, Democrats expressed concern in July that the deal may be rejected  if it doesn’t conform to the agreement reached by House democrats and President George W. Bush in 2007, which set exclusivity at five years.

“As members who support trade done right, we strongly believe that the [Trans-Pacific Partnership] must not inhibit access to lifesaving medicines,” the lawmakers wrote.

Rai said that a complicated mix of politics will decide the fate of the trade agreement. 

“It’s certainly a compromise, there’s no doubt about that,” Rai said. “In general, compromise in these areas seems to be better than one side entirely winning the game.”

Congress needs to pay attention how the deal will affect the pharmaceutical industry and smaller companies that are doing the ground level research.

The agreement raises questions about whether they would continue researching certain drugs without longer exclusivity protections.

The post Big Pharma Angered Over The Trans-Pacific Partnership Agreement appeared first on Citizens Report.

The FDA has approved Danish pharmaceutical company Novo Nordisk’s insulin drug Tresiba, which is set to be sold at a lower price than international competitors.

Danish multinational pharmaceutical company Novo Nordisk has been working unceasingly to get its insulin product Tresiba approved for sale in the American diabetes drug market.

The FDA rejected the company’s first attempt but allowed a major competitor’s drug, called Toujeo, to hit markets in April.

Now that the FDA has recently decided to allow Tresiba to enter the arena, it will be interesting to see how the drug is priced and received by doctors and patients.

An Edge In A Competative Market

Many international drug companies have attempted to break into the diabetes drug market, including French multinational pharmaceutical company Sanofi.
Image: Daily Times Gazette

Despite the celebration over the approval, Tresiba will still lack the FDA label that could spark its popularity. Although the drug is associated with heart safety and fewer episodes of hypoglycemia, the FDA is not planning on publicizing it as a comparative benefit.

Hypoglycemia is a common side effect of using insulin. With knowledge of the reduced side effects, patients may gravitate toward the new drug.

Sanofi’s drug Lantus is the most popular player. For this reason, other pharmaceutical companies will have to work harder to help their drugs gain the clout they desire.

Sanofi announced Toujeo about six months ago, and it’s likely the company is ready to launch advertising campaigns. Tresiba has about six months to go before Novo can begin public advertising.

Ronny Gal, an analyst for Bernstein & Co., said Novo’s “investment in marketing and sales has been extensive.” Novo brought in hundreds of new drug reps during the first attempt to get Tresiba approved.

However, Novo admits that Tresiba will be priced moderately in comparison to older basal insulin Levemir and Sanofi’s drug Lantus. Analysts predicted lower pricing would add appeal to new drugs entering the market.

Some predict a pricing war on the horizon between major providers and pharmacy benefits managers. Novo is looking to gain traction with “more permissive” health care plans along with the hope to persuade payers that Tresiba is worth the price.

Novo’s statement on the FDA approval illustrates a potential marketing tactic for Tresiba, which will be officially launched in the first quarter of 2016.

“[W]e are proud to bring forward the first new basal insulin molecule to be approved by the FDA in 10 years,” Novo’s U.S. chief, Jesper Høiland, said in a statement.

The post Danish Pharmaceutical Company Brings Cheaper Insulin To America appeared first on Citizens Report.

British researchers analyzed data that shed light on the rising cost of cancer drugs in the U.S., which are priced 600 times higher than the actual cost.

Consumer surveys illustrate a serious and widespread concern, presidential candidates push health care reform in their political platforms and the media continues to publicize drug makers putting profits over people.

The unreasonably high cost of pharmaceuticals in the United States has grabbed attention from politicians, advocates and consumers. Now, research exposing the actual cost of cancer drugs juxtaposed with the price charged by pharmaceutical companies will add further fuel to the fire.

Data Exposes Price-Gouging

The same cancer medications are priced differently all over the world, but these drugs are the most expensive in the U.S.
Image: 123rf

Pharmaceutical companies must pay various costs to bring a drug to market, including funding the active ingredient and other chemicals, developing the combination into a pill, arranging packaging and shipping and budgeting for a profit margin.

British researchers analyzed data that shows five common cancer drugs are priced 600 times higher than they actually cost. The cost of ingredients came from a public database called IndiaInfoDrive. The report is be presented at the European Cancer Conference in Vienna.

Leukemia drug Glivec, also known as imatinib, costs pharmaceutical companies $159 in total. However, it’s priced at $106,322 in the U.S. and $31,867 in the U.K. In Brazil, the generic version is around $8,000.

“We were quite surprised just how cheap a lot of these cancer drugs really are,” pharmacologist Andrew Hill of the University of Liverpool said. “There’s a lot of scope for prices to come down.”

Four other drugs in the same class, called tyrosine-kinase inhibitors (TKIs), also had shocking true cost comparisons.

These drugs treat cancer in the lung, breast, liver, pancreas and thyroid, in addition to leukemia. Tarceva (erlotinib), Nexavar (sorafenib), Tykerb (lapatinib) and Sprycel (dasatinib) cost anywhere from $236 for Tarceva to $4,022 for Tykerb. In the U.S., these drugs are priced at around $78,797 to $135,679.

According to Hill, more than a million cancer patients worldwide would benefit from TKIs but cannot access them because of the hefty price tag.

“Very few of them are being treated now,” he said.

The Preposterous Price Of Cancer Drugs

Health professionals believe that the price of these drugs is not equal to their value.
Image: John Tabita

The price-gouging of cancer drugs has continued to rise overall. Dr. Peter B. Bach of Memorial Sloan Kettering Cancer Center in New York tracked the rise. After adjusting for inflation he found an estimated 100 percent increase since 1965.

“The rate of rise exceeds the rise in benefits from these drugs,” Bach says. “This is a ginned-up pricing structure that isn’t a product of careful analysis. It’s not a bunch of guys in green eye-shades but a bit of dart-throwing and chutzpah. And if there’s a critical Op Ed piece or a Twitter avalanche [in response to a high price] they’ll lower it.”

Three years ago, Bach and two of his peers wrote a New York Times opinion-editorial about the refusal to prescribe a new colon cancer drug at Memorial Sloan Kettering that wasn’t as effective as the high price tag made it seem.

In response to the piece, the drug maker cut the price in half. A similar response from the CEO of Turing Pharmaceuticals occurred after a public outcry caused by the fact that he raised the price of Daraprim from$13.50 to $750-per-pill.

Hope For A Change

Presidential candidates such as Hilary Clinton and Bernie Sanders have both led campaigns that include health care reform.
Image: Southside Pride

While Obama’s administration continues to work on a way to lower the prices of pharmaceuticals nationwide, democratic candidates are attempting to make price-reducing proposals a part of their platform.

“We’ve spoken with Bernie Sanders’ advisers and shown him our results with HIV, hepatitis and cancer drugs,” Hill says.

Because Washington’s pharmaceutical lobbyists are extremely powerful, coming to an agreement on a policy change will be difficult. Pharmaceutical manufacturers argue that regulating prices will limit the likeliness of new drugs being brought to market.

Clinton’s proposal to regulate drug prices “would restrict patients’ access to medicines, result in fewer new treatments for patients, cost countless jobs across the country and could end our nation’s standing as the world leader in biomedical innovation,” according to the Pharmaceutical Research and Manufacturers Association.

The association is not alone. Bach critiques Clinton’s idea that companies should be required to assign a certain proportion of their revenue to research and development.

“Pharma uses the language of a regulated monopoly like utility companies, which argue that they need to be compensated for infrastructure costs,” Bach says. “Apple never says, ‘We charge $600 for an iPhone because of our research.’ Or Ford never says a Taurus costs X dollars because of its R&D.”

In addition, Bach disagrees with the idea that high drug prices are justified if they save patients money on hospitalization or transplants.

“That argument is unique to the pharmaceutical industry,” Bach says. “Can you imagine if Poland Spring priced their bottled water to include the value of avoiding cholera? Or if the price of condoms included the cost of an avoided pregnancy?”

The post Cancer Medication Is Grossly Overpriced In The U.S. appeared first on Citizens Report.

Addyi, a once-daily pink pill that treats hypoactive sexual desire disorder in women, will be released on Oct. 17.

Sexual dysfunction isn’t just a man’s problem. Lots of ladies deal with a low libido.

Medical professionals and gender equality advocates are making sure the female sex life is finally being addressed. Addyi, a pink pill created by Sprout Pharmaceuticals, focuses on reviving a woman’s sexual desire.

After multiple rejections and criticism from the medical industry, a powerful lobbying campaign prompted the FDA to finally stand behind Addyi.

The Story Behind ‘Female Viagra’

Addyi, also called flibanserin, is the first women’s libido pill of its kind.
Image: NY Times

Sprout Pharmaceuticals is a company “committed to breakthrough firsts in women’s sexual health.” About 7 percent of premenopausal women have hypoactive sexual desire disorder (HSDD), a condition that causes severe distress but is largely ignored by the medical community.

Addyi, also called flibanserin, is the first drug to treat a biological lack of sexual desire not attributed to factors like disease, side effects from medications or a flailing relationship. Taken once daily before bed, the 100 mg tablet works by regulating levels of dopamine and serotonin in the brain.

In 2010, Sprout bought Addyi from another manufacturer and began developing it. The pill was rejected by the FDA unanimously that same year and again in 2013.

The company partnered with women’s activists to launch a lobbying campaign that situated Addyi directly in front of the FDA. However, the opposition claimed that Sprout was using its buying power to influence a decision about a drug that shouldn’t be on the market.

Critics argue that the drug has few benefits and could be potentially dangerous.

“This is a product that is neither very effective nor particularly safe,” Dr. Susan Wood, a former FDA official now at George Washington University, told NBC News.

“It won’t benefit many women and at the same time the approval comes with a lot of restrictions, setting a precedent that a drug for women’s sexual health has to be treated in a very special way,” Wood said.

A Push To Even The Score

Nearly one-third of women aged 18 to 59 suffer from a lack of desire to have sex, according to WebMD.
Image: Patrick Chappatte

Gender equality activists have taken a few different avenues to push the drug through the approval process. The campaign generated a petition, called Even the Score.

Organizations such as the National Council of Women’s Organizations, the Black Women’s Health Imperative, Jewish Women International and some medical groups like the Association of Reproductive Health Professionals showed their support by reaching out to Congress about the drug.

“This is the biggest breakthrough for women’s sexual health since the pill,” said Sally Greenberg, executive director of the National Consumers League.

A major tenet of the campaign is the need for a level playing field. By approving a drug that was similar to Viagra and other men’s libido pills, the FDA would provide equal options for both sexes suffering from a lack of sexual desire. In addition to Viagra, men have six other options to treat sexual dysfunction.

“Today, we write a new chapter in the fight for equity in sexual health,” according to Susan Scanlan, chairwoman of the Even the Score campaign.

However, the FDA claims no gender bias exists. Viagra treats erectile dysfunction, not low sexual desire. The campaign collected more than 60,000 signatures to demonstrate the extent of the desire for the drug.

“The unmet need seems to be so strong that even for a drug with rather modest benefit, I think approving the product with strong limitations seems to be the right step at this point,” said Tobias Gerhard, a committee member and expert on drug safety at Rutgers University in New Jersey.

Female Sex Drive On The Move

Sprout has been purchased by Valeant Pharmaceuticals International with the intention of going global.
Image: NY Post

In June, Addyi was approved with an 18-6 vote by an advisory committee to the Food and Drug Administration. The FDA followed suit on Aug. 18, with specific attention to limiting risks and overuse.

Addyi has a boxed warning included on its label, which prohibits use with alcohol. If combined, Addyi and alcohol can increase the risk of low blood pressure and fainting. A few other drugs are also off limits, and people with liver impairment are excluded from prescription.

Doctors may be required to receive a certification to prescribe the drug that includes a presentation and comprehension test. The drug could cause potential side effects such as high blood pressure, fainting, nausea, dizziness, somnolence, fatigue, insomnia and dry mouth. Hypotension, syncope and central nervous system depression are also possible risks.

Recently, Valeant Pharmaceuticals International purchased Sprout for about $1 billion. It seems that Valeant is excited to be a part of the breakthrough by assisting in the development of medications that are tailored to women.

“We applaud the efforts of the Sprout team to address this important area of unmet need and look forward to working with them to bring the benefits of Addyi to additional markets around the world,” according to J. Michael Pearson, CEO at Valeant.

Cindy Whitehead, the chief executive of Sprout, hasn’t given a prediction about the sales of Addyi. The drug will be available starting Oct. 17.

Although it’s not clear if insurance companies will pick up Addyi, the price will be equivalent to the cost of male erectile dysfunction medication.

Read the full Certification Press Release and Distribution Strategy here.

The post First Women’s Libido Pill Available Soon appeared first on Citizens Report.

The International Federation of Health Plans concluded that Americans are paying six times more for prescription medication than the rest of the world.

The unreasonably high price of pharmaceuticals in the United States has shined a bright light on the drug industry, exemplifying the fact that Americans are paying much more for medication than patients in other countries.

The government healthcare budget for prescription drugs is low in comparison to other nations.

Structural Inequalities

Americans are paying more for brand-name drugs across the board, but cancer patients and those in need of specialty medications are the hardest hit.
Image: Jaron Associates

American insurance companies pay about $215 per customer each month for the acid reflux drug Nexium. In the Netherlands, an equivalent prescription costs about $23.

Data from the International Federation of Health Plans shows that pharmaceuticals in the United States are six times more expensive than in other countries.

The priciest drugs are specialty and cancer medications, but standard prescriptions are costly as well. Cancer treatment pill Gleevec costs patients about $6,214 per month in the United States, compared to $1,141 in Canada and $2,697 in England.

Rheumatoid arthritis drug, Humira, is $2,246 in the United States, compared to $881 in Switzerland and $1,102 in England.

Americans who suffer from depression could pay $194 for Cymbalta, but the price is $46 in England and $52 in the Netherlands.

The health care system in the Unites States is more competitive than other countries. Fewer players would allocate more purchasing power to certain groups, which would give them the ability to negotiate a reduced cost.

The United Kingdom’s National Health Service supplies the country’s drugs through bulk purchases called formularies. The U.S. has multiple unregulated private insurance firms, hospitals and plans that buy for individual groups of consumers. Through different plans, consumers allow companies to negotiate prices with the pharmaceuticals on their behalf.

But a smaller pool of negotiators yields more power to the consumer, allowing patients to decide what they are willing to pay.  In a system like this, companies are forced to make fair negotiations if they want to be a part of the marketplace.

The Root Of The Problem

Pharmaceutical companies have the power to set drug prices without explanation.
Image: Budding Into Fullness

Pharmaceutical companies are in control of setting drug costs, and it’s clear that they are putting profits before people.

A Kaiser Family Foundation poll found that 72 percent of Americans think drug costs are unreasonable and want drug companies to release information on how they set prices. The current system leaves consumers without a choice or an explanation.

Pharmaceutical trade group PhRMA attributes the high prices to the funding of research and development. According to PhRMA, companies invest almost $2.6 billion dollars on average for more than 10 years to bring a drug into the marketplace. Many new drugs never make it.

But critics disagree. Many medical experts believe that drug companies set the prices high solely because they can.

“We have no rational system in the U.S. for managing prices of drugs,” Dr. Peter B. Bach, director of Director of Memorial Sloan Kettering’s Center for Health Policy and Outcomes told CNN.

Medicare provides drug treatments for a majority of Americans, but the provider is prohibited from negotiating with drug companies. Presidential candidates Hilary Clinton and Bernie Sanders have addressed necessary industry changes as a  core of their platforms.

“People should not have to go without the medication they need just because their elected officials aren’t willing to challenge the drug and health care industry lobby,” Sanders said in a statement on his official website. “Between our government’s unwillingness to negotiate prices and its failure to effectively fight fraud, it’s no wonder drug prices are out of control.”

In Germany, nonprofit health insurers are able to bargain with pharmaceuticals and health providers to get the best price possible. Medicare should be able to use its buying power to set prices by negotiating directly with pharmaceutical companies to find a reasonable cost.

The United States lacks a central agency, federal or non-governmental, to conduct research that focuses on drug efficacies. A system in Canada allows providers to compare drugs to similar treatments on the market to determine an accurate price.

Only by regulating the drug industry and gaining the power to negotiate with pharmaceutical companies will the price of pharmaceuticals in America decline.

“Those guys are profit driven. That’s a big problem,” said Kesselheim.

The post Why Are U.S. Patients Paying More For Pharmaceuticals? 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.

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Turing Pharmaceuticals raised the price of a life-saving drug more than 55 times the original cost. The price-gouging has caused a serious media and medical outcry.

The high cost of pharmaceuticals is a widespread issue in the United States. Pharmaceutical price-gouging is something that presidential candidates are trying to combat, but the seriousness of the problem wasn’t as clear until the cost of a life-saving drug was raised by 5500 percent.

Turing Pharmaceuticals of New York acquired the rights to Daraprim, a drug that treats infection from a common parasite. After buying Daraprim from Impax Laboratories, Turing increased the cost of the drug from $13.50 per pill to $750 per pill.

A Life-Saving Drug

Daraprim is on the World Health Organization’s List of Essential Medicines, which means that it is a necessity in a basic health system.
Image: Share Tu

Daraprim, also known as pyrimethamine, has been on the market since 1953. It is an antiparasitic compound that treats protozoal infections such as malaria and toxoplasmosis.

While malaria is almost unheard of in the United States, toxoplasmosis is a frequent cause of illness. Toxoplasmosis, the most common food-borne disease, attacks a weakened immune system. The condition is life-threatening and has the potential to kill patients whose natural defense mechanisms have been weakened from cancer, HIV/AIDS and even pregnancy, according to the CDC.

About 60 million people in the United States may carry the toxoplasma parasite, according to the CDC. The parasite is spread from eating under-cooked meat, drinking unclean water and coming into contact with contaminated cutlery or infected feces.

The parasite can be passed to unborn children during pregnancy or through organ transplants. The flu-like symptoms may seem mild, but the parasite is deadly. It attacks the brain and can cause blindness and brain damage.

Outrage From The Medical Community

The HIV Medicine Association and the Infectious Diseases Society of America are two of the health organizations that have protested the price-gouging of Daraprim.
Image: Blogger

Doctors, patient and other health professionals are outraged by the rising cost of prescription drugs.

Turing Pharmaceuticals was contacted by the HIV Medicine Association and the Infectious Diseases Society of America to share concerns about the high cost. The pricey pill may not be stocked in hospitals if it the institution can’t afford to buy in bulk. But no alternative treatment is effective enough, which means that many patients won’t have access to the medication they need.

The cost increase makes the medication unaffordable, even for people with insurance. High-price drugs are categorized as “specialty” medications, and patients will pay hundreds or even thousands of dollars every year. Most insurance plans require patients to pay 20 percent of the drug cost, which would equate to $150 a pill.

“This is a tremendous increase,” said Judith Aberg, a spokesperson for the HIV Medicine Association.

In 2013, the average cost of medication increased by 13 percent, according to a report from the Prime Institute at the University of Minnesota. Cancer treatments now cost more than $100,000 a year. The brand-name hepatitis C drug, Sovaldi, costs $84,000 for a 12-week treatment.

“Every week, I’m learning about another drug that has increased in price because of a change in marketing or the distributor,” Aberg said.

CEO Set To Lower The Price

In response to the media outcry, Martin Shkreli, CEO of Turing Pharmaceuticals, plans to lower the price. The company hasn’t determined the amount. 
Image: The Guardian

Turing said the company is working with hospitals and providers to make the drug accessible through co-pay assistance programs and free-of-charge options for uninsured patients, according to Turing spokesman Craig Rothenberg.

Rothenberg said there is a purpose for the high price. The income will be used to research treatments for toxoplasmosis and invest in marketing and education to promote awareness about the disease. The goal is to develop a toxoplasmosis treatment with less side effects.

“There has been no innovation in dealing with toxoplasmosis,” Rothenberg said. “That has been a long neglect in the patient community.”

But after the medical community expressed their disdain for the price hike, Turing’s CEO Martin Shkreli has agreed to lower the cost by an unknown amount. The company paid $55 million for the rights to Daraprim, and Shkreli claims he’s just trying to get an adequate return on his investment.

“Yes it is absolutely a reaction — there were mistakes made with respect to helping people understand why we took this action, I think that it makes sense to lower the price in response to the anger that was felt by people,” Shkreli told NBC.

On Twitter, Shkreli said he would “set the record straight on misconceptions and announce some adjustments to our plan.” Despite the low production costs, the company still needs to finance “the quality control, the regulatory costs, and all of the other things that come with having a drug company.”

“We’ll know in several weeks how profitable the drug is, if it at all,” Shkreli said in an NBC interview. “It may turn out that’s it not even profitable at all, even at this price.”

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