A specialty drug company called Imprimis Pharmaceuticals has responded to the price-gouging of Daraprim by creating a cheaper alternative.

Turing Pharmaceuticals purchased the rights to the parasite-fighting drug Daraprim in August and raised the price to $750 per pill. Both media and medicine were outraged, sparking a full-on protest that condemned the company’s CEO Martin Shkreli.

Shkreli agreed to lower the price, but that didn’t stop specialty drug manufacturer Imprimis Pharmaceuticals from creating an immensely cheaper alternative.

A Comparable Product With Added Benefits

The compound created by Imprimis Pharmaceuticals has added benefits that will blow Daraprim out of the spotlight.
Image: Hispanics News Network

Daraprim, also known by its generic name pyrimethamine, has existed since 1953. It is used to treat parasitic infections that prey on patients with weakened immune systems, such as those with cancer and HIV/AIDS. These patients are more likely to develop a condition called toxoplasmosis, which causes muscle pain, fever and headaches.

Imprimis Pharmaceuticals, located in San Diego, plans to make a comparable version of the medication for $1 a pill. That’s $749 less than Turing planned to charge. The alternative version would also include a chemical called leucovorin.

“According to the Centers for Disease Control and Prevention, pyrimethamine works to block folic acid synthesis in the parasite T. gondii, the cause of toxoplasmosis, and leucovorin helps to reverse the negative effects on bone marrow caused by this mechanism of action,” the company said.

The drug has changed hands a number of times. Daraprim was originally manufactured by GlaxoSmithKline for about $1 a tablet, and then Impax Laboratories for $13.50 a tablet. Turing bought the drug in August for $55 million and raised the price to $750 per pill.

However, the most recent version of the drug has added benefits from the leucovorin. This version will be sold at a price that is closer to the original cost.

“Imprimis is now offering customizable compounded formulations of pyrimethamine and leucovorin in oral capsules starting as low as $99.00 for a 100 count bottle, or at a cost of under a dollar per capsule. Compounded medications may be appropriate for prescription when a commercially-available medicine does not meet the specific needs of a patient,” the company said.

The Importance Of Access

A new program called Imprimis Cares works to make necessary drugs affordable for the general public.
Image: Our Health

It seems likely that there won’t be much competition when deciding where to purchase the antiparasitic compound.

If Turing were to monopolize the drug, it would cost about $336,000 a year to treat someone with toxoplasmosis, according to the Infectious Diseases Society of America and the HIV Medicine Association.

“While we respect Turing’s right to charge patients and insurance companies whatever it believes is appropriate, there may be more cost-effective compounded options for medications, such as Daraprim, for patients, physicians, insurance companies and pharmacy benefit managers to consider,” Imprimis CEO Mark Baum said in a statement.

“This is not the first time a sole supply generic drug — especially one that has been approved for use as long as Daraprim — has had its price increased suddenly and to a level that may make it unaffordable,” Baum said.

“In response to this recent case and others that we will soon identify, Imprimis is forming a new program called Imprimis Cares which is aligned to our corporate mission of making novel and customizable medicines available to physicians and patients today at accessible prices,” Baum said.

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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.

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.

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.

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