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11, December, 2019

Price of Daraprim, vital drug in the treatment of opportunistic infections, rises more than 5000% in the dead of night

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daraprim-02Infectious disease experts are protesting a gigantic rise in the price of a patented drug sixty-two years ago that is the standard of care for treating a parasitic infection that threatens the lives of HIV-positive or AIDS patients.

The drug, called Daraprim, was purchased in August by Turing Pharmaceuticals, a start-up run by a former hedge fund manager. Turing immediately raised the price of $ 750 a tablet of $ 13,50, bringing the annual cost of treating some patients hundreds of thousands of dollars.

"What are they doing differently that has led to this dramatic increase? "Said Dr. Judith Aberg, head of the Division of Infectious Diseases at the Icahn School of Medicine at Mount Sinai. She said that raising prices could force hospitals to use "alternative therapies that may not be as effective."

Restructuring the price increase is not an isolated case. While most of the focus on pharmaceutical prices was on new drugs for

Cancer, hepatitis C and high cholesterol, there is also growing concern about the huge price increases in older drugs, some of them generic, which for some time were pillars of treatment.

Although some price increases have been caused by the other shortages, what appears to be a business strategy of buying old abandoned drug patents and then increasing them "

Cycloserine, a drug used to treat dangerous multidrug-resistant tuberculosis, was only an increase in the price of $ 10.800 of 30 tablets of $ 500 after its acquisition by Rodelis Therapeutics. Scott Spencer, Rodelis general manager, said the company needed to invest to make sure the supply of the drug remained reliable. He said the company provided the drug free for certain patients in need.

In August of the same year, two members of Congress investigating generic drug price increases wrote to Valeant Pharmaceuticals after the company acquired two heart disease drugs, Isuprel and Nitropress, from Marathon Pharmaceuticals and promptly lifted their prices from sale at 525 percent and 212 percent, respectively. Marathon had purchased the drug from another company on 2013 and had quintupled its prices, according to lawmaker Sen. Bernie Sanders, an independent Vermont who is seeking the Democratic nomination for president and Rep. Elias E. Cummings, Democrat of Maryland.

Doxycycline, an antibiotic, went from $ 20 the bottle in October from 2013 to $ 1.849 per April from 2014, according to the two lawmakers.


The American Society of Infectious Diseases and HIV Medicine Association sent a joint letter from Turing earlier this month that the price increase for Daraprim "unjustifiable for the vulnerable patient population" and "unsustainable for the health care system." An organization representing the state administration programs to fight against AIDS has also been looking at the rising prices, according to doctors and patient advocates.

Daraprim, commonly known as pyrimethamine, is primarily used to treat toxoplasmosis, a parasitic infection that can cause serious health or life-threatening harm to babies born to women who become infected during pregnancy, and also to people with an immune system committed, such as patients with AIDS and some cancer patients.

Martin Shkreli, the fascinator ... I say, the founder and chief executive of the restructuring, said that the drug is so rarely used that the impact on the health care system would be negligible and that Turing could use the money he earns to develop better treatments for toxoplasmosis , with fewer side effects.

"This is not the greedy move of a drug company trying to chisele patients, it's about us trying to stay in business," Mr. Shkreli said. He said many patients use the drug for much less than a year and that the price was now more in line with those of other rare disease drugs.

"This is still one of the smallest pharmaceuticals in the world," he said. "It really does not make much sense to make any criticism of that. ".

This is not the first time the ambitious CEO of 32 year-old Mr. Shkreli, who has a reputation for both brilliance has been the center of a controversy. He started MSMB Capital, a hedge fund company, in its early twenties called attention by urging the Food and Drug Administration not to approve certain drugs made by companies whose equity capital it has shut down.

At 2011, Mr. Shkreli started Retrophin, which acquired also acquired old and abandoned drugs and raised their prices sharply. Board of Directors Retrophin burns Mr. Shkreli one year ago. Last month, he filed a complaint in the Federal District Court of Manhattan, accusing him of using Retrophin as a personal piggy bank to pay back investors in his anger hedge fund.

Mr Shkreli denied the allegations. He has filed a request for arbitration against his former company, which he says owes him at least $ 25 million in damages. "They're trying to demonize me for trying to get success and money," he said.

Daraprim, which is also used to treat malaria, has been approved by the FDA in 1953 and has long been made by GlaxoSmithKline. Glaxo has sold marketing rights to the United States for CorePharma in 2010. Last year, Impax Laboratories agreed to buy Core and affiliated companies for $ 700 million. In August, Impax sold Daraprim to the restructuring of $ 55 million, a deal announced the same day Turing said it had raised $ 90 million from Mr. Shkreli and other investors in its first round of financing.

Daraprim costs only about $ 1, a tablet several years ago, but the price of the drug increased sharply after CorePharma acquired it. According to IMS Health, which tracks prescriptions, drug sales jumped to 6,3 millions of dollars in 2011 from 667.000 to 2010 in 12.700, still as prescriptions remained at approximately 2014. At 9,9, after further price increases, sales were $ 8.821 million, the number of prescriptions decreased to XNUMX. The figures do not include hospitalization.

Restructuring the price increase can bring sales to tens or even hundreds of millions of dollars per year if usage stays constant. Medicaid and some hospitals will be able to get the cheap drug under federal rules of rebates and rebates. But private insurers, Medicare and hospitalized patients would have to pay an amount close to the list price.

Some doctors questioned Turing's and said there was a need for a better drug, saying: side effects, while potentially serious, can be managed.

"I certainly do not think this is one of those diseases we've been clamoring for for better therapies," said Dr. Wendy Armstrong, a professor of infectious diseases at Emory University in Atlanta.

Now with the high price, other companies could eventually make generic copies, since the patents have time and have expired. One factor that could discourage this option is that the Daraprim distribution is now tightly controlled, which makes it harder for generic companies to get the samples they need for the test.

The contactor of controlled distribution pharmacies was made in June by Impax, not Turing. Nevertheless, distribution control was a

Mr. Shkreli spoke about his previous company as a way of counteracting generics.

Some hospitals say they now have trouble getting the drug. "We did not have access to the drug for a few months," said Dr. Armstrong, who also works at Grady Memorial Hospital, a large public treatment center in Atlanta that serves many low-income patients.

But Dr. Rima McLeod, a medical director at the University of Chicago toxoplasmosis center, said Turing had been good about delivering medications quickly to patients, sometimes without charge.

"They have diverted every time I have called," she said. The situation, he added, "seems feasible," despite the rise in prices.

Daraprim is the first treatment standard for toxoplasmosis in combination with an antibiotic called sulfadiazine. There are alternative treatments, but there is less data supporting its effectiveness.

Dr. Aberg of Mount Sinai said some hospitals will now find Daraprim too expensive to keep in stock, possibly resulting in delays in treatments. She said the solution at Mount Sinai was to continue using the drug, but each use now needs special analysis.

"That seems to be all-for-profit for someone," Dr. Aberg said, "and I just think it's a very dangerous process."


Translated from the original into English in Drug Goes From $ 13.50 to Tablet to $ 750, Overnight by Cláudio Santos de Souza

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