Thursday, November 26, 2015

Shades of Questcor 2

After weeks of criticism from patients, doctors and other drugmakers for hiking a life-saving medicine’s price more than fifty-fold, Turing Pharmaceuticals is reneging on its pledge to cut the $750-per-pill price.

Instead, the small biotech company is reducing what it charges hospitals, by up to 50 per cent, for its parasitic infection treatment, Daraprim. Most patients’ co-payments will be capped at $10 or less a month. But insurers will be stuck with the bulk of the $750 tab. That drives up future treatment and insurance costs.

[Martin Shkreli, chiel executive officer of  Turing Pharmaceuticals and KaloBios Pharmaceuticals, Inc.] The 32-year-old likes sunglasses, golf shirts, the hip-hop artist Eminem, a bottle of 1982 Lafite-Rothschild, and jacking up the price of a pill used by people who suffer from HIV

Daraprim is a 62-year-old pill whose patent expired decades ago. It’s the preferred treatment for a rare parasitic infection, toxoplasmosis, which mainly threatens people with weak immune systems, such as HIV and organ transplant patients, and pregnant women, because it can kill their baby. Dr. Carlos del Rio, chairman of the HIV Medicine Association, called Turing’s changes “just window dressing.”

Turing’s move comes after a pharmacy that compounds prescription drugs for individual patients, Imprimis Pharmaceuticals, started selling a custom-made version for 99 cents per capsule. Those sales weren’t a factor in Turing’s pricing strategy, chief marketing officer Nancy Retzlaff said Wednesday.

Del Rio noted that while hospitals treat many patients initially, most are then treated at home for a couple months, so the lower hospital price doesn’t help.

“This medication can be made for pennies. They need to reduce the price to what it was before,” he said.


  1. San Diego-based Imprimis Pharmaceuticals Inc., which mixes approved drug ingredients to fill individual patient prescriptions, said Thursday it will supply capsules containing Daraprim’s active ingredients, pyrimethamine and leucovorin, for $99 for a 100-capsule bottle, via its

    A 100-capsule bottle of Daraprim from Shkreli’s Turing Pharmaceuticals will only run you $75,000, no big deal.

    Imprimis CEO Mark Baum has spotted a niche for his company, undercutting pharmaceutical companies who’ve jacked prices on other generic drugs through the roof.

    “We are looking at all of these cases where the sole-source generic companies are jacking the price way up,” Baum said in an interview. “There’ll be many more of these” compounded drugs coming in the near future.

    Hilariously, Shkreli paid $55 million in August for the rights to Daraprim before pulling his price-gouging stunt. And now?

    Imprimis, which primarily makes compounded drugs to treat cataracts and urological conditions, will work with health insurers and prescription benefit managers in each state to make its new capsules and other compounded generic medicines widely available, Baum said.

    “We’re geared up. We’re ready to go as soon as the orders come in,” he said.

    Gawker "Heroic Pharmaceutical Company Savagely Undercuts Martin Shkreli's Pill Scam" October 22, 2015

  2. While Martin Shkreli and Turing Pharmaceuticals Daraprim drug has been getting a lot of attention for all the wrong reasons, Imprimis Pharmaceuticals Inc (NASDAQ:IMMY) seems to have found a solution.

    Imprimis has created an alternative custom made drug which is almost identical to Daraprim, but instead of costing $750 per pill, costs just 99 cents. According to Imprimis CEO Mark Baum, orders of their new drug are pouring in.

    Imprimis Pharmaceuticals (IMMY) stock increased 15.72% or $1 on November 27, hitting $7.36. About 147,640 shares traded hands. IMMY has declined 7.65% since April 27, 2015 and is downtrending. It has underperformed by 6.29% the S&P500.


  3. Martin Shkreli, a lightning rod for growing outrage over soaring prescription drug prices, was arrested in New York by the FBI on Thursday on securities fraud charges involving his former hedge fund and a pharmaceutical company he previously headed.

    Shkreli, who is now chief executive officer of Turing Pharmaceuticals and KaloBios Pharmaceuticals Inc, was charged in a federal indictment related to his time managing hedge fund MSMB Capital Management and heading biopharmaceutical company Retrophin Inc.

    The indictment, filed in Brooklyn, New York, also charged Evan Greebel, a former partner at law firm Katten Muchin Rosenmann who was Retrophin's outside counsel.

    Brooklyn U.S. Attorney Robert Capers is scheduled to hold a press conference with officials from the Federal Bureau of Investigation and U.S. Securities and Exchange Commission at noon EST (1700 GMT) to announce the charges, his office said...

    A privately held startup, Turing sparked controversy earlier this year after news reports that it had raised the price of Daraprim, a 62-year-old treatment for a dangerous parasitic infection, to $750 a tablet from $13.50 after acquiring it.

    The charges predate Turing and relate to Shkreli's management of New York-based hedge fund MSMB Capital Management, whose closure he announced in 2012, and his time as CEO of Retrophin from 2012 to 2014.

    The indictment said Shkreli made false representations to MSMB investors to draw in $3 million in investments.

    After MSMB suffered devastating trading losses in 2011 and ceased trading, Shkreli for months sent fabricated updates to investors touting profits of as high as 40 percent since inception, the indictment said.

    He also solicited $5 million from investors for another fund, MSMB Healthcare Management LP, while concealing his performance managing MSMB Capital and a prior fund and providing investors an inflated valuation of his then-private firm Retrophin, the indictment said.

    To pay back the MSMB funds' investors, Shkreli and Greebel misappropriated $11 million in Retrophin assets through settlement agreements and sham consulting deals, according to the indictment.

    The case mirrors a lawsuit Retrophin filed in August against Shkreli in federal court in Manhattan for $65 million, claiming he had used his control over Retrophin to enrich himself and pay off MSMB investors' claims.

    Shkreli has denied the allegations.

  4. Martin Shkreli, the medical entrepreneur widely criticized for ordering large drug price hikes, resigned Friday as CEO of Turing Pharmaceuticals, one day after federal authorities charged him in an unrelated securities fraud scheme.

    The privately held company said Ron Tilles, chairman of the biopharmaceutical firm with offices in New York and Switzerland, will serve as interim CEO while retaining his current position.

    "We wish to thank Martin for helping us build Turing Pharmaceuticals into the dynamic research focused company it is today, and wish him the best in his future endeavors, Tilles said in a statement issued with the announcement. "At the same time, I am very excited about the opportunity to guide Turing Pharmaceuticals forward."...

    The statement referred to the public furor that erupted this year after Shkreli raised the price of a Turing medication called Daraprim by more than 5000% — from $13.50 a pill to $750. The therapy treats toxoplasmosis, a parasitic disease that afflicts people with weakened immune systems, such as individuals suffering from AIDS and pregnant women.

    Doctors and other medical industry experts criticized the increase, which also became a topic in the 2016 U.S. presidential campaigns.

    Responding to the outcry, Shkreli initially said he would roll back the Daraprim price hike. But he subsequently dropped that plan and repeatedly defended the increase.

    Tilles' statement said Turing was "committed to ensuring that all patients have ready and affordable access to Daraprim" and Vecamyl, a Turing drug for treating malignant hypertension, high blood pressure that develops suddenly.

    Turing separately pledged that "no patient needing Daraprim will be denied access." The company also issued a letter to health care providers that said Turing's Daraprim Direct program "continues to provide physicians and their patients with multiple assistance options."

  5. It’s time — past time, really — to name the person of the year. (TIME Magazine does it. Why not me?)

    There were many worthy candidates in 2015: the Pope, the Donald and Luke Skywalker, to name just a few. But only one symbolized the spirit of the year.

    I speak, of course, of Martin Shkreli.

    For those of you with short-term memory problems, he’s the weasel/drug honcho who bought the rights to a lifesaving drug that had been on the market for years, and immediately raised its $13.50-a-pill price to $750 — a 5,000 percent hike.

    He said he’d use the extra money for research to develop a lifesaving drug of his own, but nobody believed him. He was just doing what a long line of drug company executives do — gouge desperately sick people.

    There’s nothing illegal about this, and it’s not even the worst example. Questcor Pharmaceuticals paid $100,000 for an existing drug that treated breathing problems in newborns and raised its price over a relatively short time from $50 a vial to $28,000.

    New cancer drugs often cost $10,000 a month or more.

    Drug companies are allowed to charge whatever they can get away with, so long as they claim they’re using the profits to develop new drugs. They don’t have to actually do it. All they need to do is say that’s their intent. It’s the American way.

  6. No matter where you turn these days, you cannot avoid Martin Shkreli. He is the man who achieved infamy by cornering the market on a drug used to fight protozoal infections in people with AIDS and people with malaria. That drug used to cost $13.50 a pill. By the time Shkreli was done with it, he had jacked up the price over 50-fold to $750 a pill.

    He cornered the market on a 62-year-old drug, and in doing so, probably retired for all time the award for Jerk of the Year in healthcare. Exploiting desperate people who need that drug by charging a ridiculous price is obviously morally abhorrent. But are Shkreli and his shenanigans really something we should spend a lot of time worrying about?

    You may be surprised that I am going to say no. There is no doubt that this evil, amoral twerp deserves his comeuppance. He is a guy who not only has cornered the market for this drug, but he is also apparently involved in securities fraud—at least the government thinks he has been running some type of Ponzi scheme—so they are after him, too.

    But Shkreli is an aberration. It does not help us to send him to jail, or vilify him, or have congressional hearings about him because none of this gets at the underlying problem, which is the high cost of drugs in the United States. We are paying three times as much as Britain, six times as much as Brazil, almost 18 times as much as India...

    The problem is systematic. Too many pharmaceutical companies are evergreening their patents. They are saying, "By making a slight twist to our drug, making a PM version or a long-acting version, we can extend our patent and keep generic competition out."...

    And a big government policy problem is that we do not bargain for the price of drugs...

    That is not what they do with drug pricing in Canada; that is not what they do in Britain; that is not what they do in Australia. That is not what they do anywhere except in the United States. Other countries use the government purchasing power to negotiate better prices. Here, we practically ask the pharmaceutical company, "What do you want to charge?" Then we pay it.

    Looking at Shkreli and his dastardly activities may be worth a few moments of our time. But getting at the systematic problems that face us in terms of escalating drug prices and paying more than anybody else in the world—that is worth a lot more of our time.

  7. After Martin Shkreli raised the price of anti-parasitic drug Daraprim more than 50-fold to $750 a pill last year, he said he wasn’t alone in taking big price hikes.

    As it turns out, the former drug executive was right. A survey of about 3,000 brand-name prescription drugs found that prices more than doubled for 60 and at least quadrupled for 20 since December 2014.

    Among the biggest increases was Alcortin A, a combination steroid and antibiotic gel to treat eczema and skin infections: The price soared 1,860 percent, or almost 20-fold, during the period. And a vial of Aloprim, a Mylan NV drug for cancer complications, more than doubled, according to the survey by DRX, a provider of price-comparison software to health plans.

    Skyrocketing prices are getting increased scrutiny ahead of a U.S. congressional hearing this week: Democratic Representative Elijah Cummings, ranking member on a committee that is probing drug pricing, said Tuesday that pricing “tactics are not limited to a few ‘bad apples,’ but are prominent throughout the industry.”

    Even after soaring prices became an issue in the U.S. presidential campaign, the cost of many drugs has continued to rise at annual rates of more than 10 percent. Drugmakers raised the prices of products as wide-ranging as erectile dysfunction drug Viagra, heart treatments, dermatology medicine and even brands that long have lost their patents. While specialty companies have had the steepest hikes, giants such as Pfizer Inc. and GlaxoSmithKline Plc kept pushing through smaller rises...(continued)

  8. (continued)Among recent increases by the world’s biggest pharmaceutical companies is AstraZeneca Plc’s blockbuster cholesterol drug Crestor, up 15 percent ahead of the arrival of a generic version in May. AstraZeneca said that it decides on price changes annually based on market conditions, a common industry practice, and it offers a savings program on Crestor that reduces co-payments to as little as $3 per prescription.

    Pfizer raised prices for 24 drugs by 12 percent or more in the past two months, with Viagra increasing about 13 percent and two heart drugs whose price went up 44 percent and 86 percent, according to DRX. The New York-based drugmaker said that list prices don’t reflect discounts offered to the government, managed-care organizations, commercial health plans and programs that restrict any increases above the inflation rate. In the U.S. biopharma business, the average price increase was 6 percent last year, Pfizer said in an e-mail.

    Meanwhile GlaxoSmithKline increased prices by 15 percent on 22 products over the past two months, including Lamictal XR for epilepsy, according to DRX.

    DRX, a unit of Connecture Inc., looked at prices for more than 6,300 doses of about 3,000 brand-name drugs from December 2014 through Jan. 15. It included patented drugs as well as old brand drugs whose patents have expired, but not generics. Half the drugs got a price increase -- including 1,100, almost a third, above 10 percent. Only about 50 had a decrease, DRX found.

    Valeant Pharmaceuticals International Inc., which in recent months has been under fire for its pricing was among the most aggressive, with 13 drugs that doubled or more since December 2014. That’s more than any other large company, the survey found. The heart drug Isuprel soared 720 percent over the period, including 525 percent right after Valeant bought the rights to sell it.

    In a December 2014 e-mail released Tuesday by the House Committee on Oversight and Government Reform, a Valeant official wrote to a senior vice president that a potential purchase of Isuprel and another drug, Nitropress, “would also have to be a price play.”

    In a statement, Valeant said that it heard feedback from hospitals that it set the prices too high for the drugs and responded by offering discounts of as much as 30 percent. On Friday, Valeant said in a separate statement that it sets prices based on factors such as the cost of development or acquisition of a drug, its benefits versus alternative treatments, and the availability of substitutes or generics.

    Valeant Pharmaceuticals International Inc., which in recent months has been under fire for its pricing was among the most aggressive, with 13 drugs that doubled or more since December 2014. That’s more than any other large company, the survey found. The heart drug Isuprel soared 720 percent over the period, including 525 percent right after Valeant bought the rights to sell it.

    In a December 2014 e-mail released Tuesday by the House Committee on Oversight and Government Reform, a Valeant official wrote to a senior vice president that a potential purchase of Isuprel and another drug, Nitropress, “would also have to be a price play.”

    In a statement, Valeant said that it heard feedback from hospitals that it set the prices too high for the drugs and responded by offering discounts of as much as 30 percent. On Friday, Valeant said in a separate statement that it sets prices based on factors such as the cost of development or acquisition of a drug, its benefits versus alternative treatments, and the availability of substitutes or generics.

  9. Outrage over the massive EpiPen price hike feels like deja vu. A year ago, America was in shock when a drug called Daraprim that's used by some AIDS and transplant patients skyrocketed overnight from $13.50 to $750 a pill.

    Hillary Clinton tweeted that the 5,000% spike was "outrageous" and amounted to "price gouging." Nothing about the drug itself had changed except this: a new company -- Turing Pharmaceuticals -- had bought the rights to distribute it. The Daily Beast dubbed Turing's CEO "the most hated man in America."

    A year later, one pill of Daraprim costs $375 for many patients.
    Turing hails this as a 50% reduction in price, but doctors are livid. The drug still costs 2,500% more than before the hike.

    "It remains criminal," say Dr. Wendy Armstrong, a medical professor at Emory University and head of the Infectious Diseases Program at Grady Health System in Atlanta, Ga. "It's still an immense financial burden for a drug that should be $1 a pill."

    Turing says it has put in place programs to "ensure access to Daraprim for every single patient who needs the drug, regardless of ability to pay." Controversial CEO Martin Shkreli also left the company late last year.

    But doctors say the reality is Turing has created an expensive, bureaucratic hurdle for patients to get a drug that can save their life. And now other companies appear to be following the "Turing playbook."…

    Dr. Judith Aberg was one of the first to sound the alarm bell by speaking to the New York Times. She's head of infectious diseases at the Icahn School of Medicine at Mount Sinai in New York City and a well known HIV and AIDS researcher.(continued)

  10. (continued)"A year later, it's still frustrating," Dr. Aberg told CNNMoney. "What's more frustrating is that other companies are following Turing's lead. At some point, our economy can't support this."
    This week, outrage erupted again over the dramatic rise in costs of EpiPens that many rely on to save them from life-threatening allergic reactions. A standard two-pack of EpiPens now costs about $600. The price was $100 in 2009.

    The CEO of the company that makes the EpiPens is using many of the same arguments that Turing did when it raised the price of Daraprim. She's blaming the broken health care system, arguing programs are in place to help those with great financial need and saying the company needs profits to fund research. Former Turing CEO Shkreli has been tweeting his support.

    Daraprim still only costs $1 or $2 a pill abroad. Turing only has the U.S. rights to distribute it. Doctors around the world have flooded Dr. Aberg's inbox with offers to send her supplies from their countries.

    "It's not illegal what they've done [at Turing], but it's unethical and immoral," says Dr. Aberg "This is affecting patient care."

    As hospitals try to keep costs downs, doctors have been discouraged from using Daraprim. Dr. Aberg says her team used to prescribe it about five times a month. Now they're down to using it once, if that. They have turned to alternatives that aren't nearly as well tested with unknown side effects.

    "That doesn't make patients feel confident. It doesn't make us feel confident," she says. The main ingredient in Daraprim is now available compounded with another drug. Imprimis Pharmaceuticals sells this alternative compound for $1 a pill.

    Turing has made a big deal about programs it has created to reduce the costs for patients. For instance, it says that the drug is available for free to people with deep financial need.
    But Dr. Aberg has watched her patients have to "jump through the hoops" to get it. Patients have to prove both financial need and health status, something that's difficult to focus on when their lives are in danger. In June, one of her patients gave up on the process. The patient switched therapies, only to suffer a negative side effect.

    The application also requires patients to sign broad disclosures "to use and disclose all of my individually identifiable health information." Dr. Aberg says some patients, especially with HIV and AIDS, are hesitant to do that.

    Turing argues that "approximately two-thirds of Daraprim sales are to federal and state health programs that pay Turing just 1 cent per pill."

    It's true that Medicaid and certain AIDS clinics -- known as 340B programs -- get a reduced rate. But again, patients have to apply to be in those programs and facilities. Dr. Armstrong currently has a patient with a brain infection who she's trying to get into a 340B program.

    "This is a big burden for someone with a very significant brain infection and (not able to think clearly) currently," says Dr. Armstrong. "It's layers or hurdles for people that already have challenges."

    Then there's people with insurance. An expensive drug like Daraprim is often put in a top tier, meaning a patient has a higher than normal copay.

    Even at a 20% copay, a four-month supply of Daraprim at two pills a day would mean a patient paying about $18,000 out of pocket.

  11. In the wake of a Zika epidemic, the world seems to have forgotten that other infectious diseases, such as toxoplasmosis, can also cause life-changing sequelae in pregnant women and their developing fetuses. Treatment for this infection (Daraprim) is quite costly in the United States—$750 per pill—however, students from an Australian high school have found a way to manufacture it for under $5. Whether or not this discovery will lead to a cheaper treatment option for those who are suffering with the infection remains to be seen.

    According to the Centers for Disease Control and Prevention (CDC), toxoplasmosis has among the highest rates of death related to food-borne illnesses. This disease is caused by Toxoplasma gondii. Although infection with this parasite does not always cause serious symptoms, infection can be detrimental in the immunocompromised, elderly, newborns, infants, and pregnant individuals...

    Treatment options for toxoplasmosis include pyrimethamine and sulfadiazine plus folinic acid. Pyrimethamine and sulfadiazine are both included in WHO’s List of Essential Medicines. As such, it came as no surprise that when the cost of Daraprim, the brand name for the generic pyrimethamine, skyrocketed from $13.50 a pill to $750 a pill, people were infuriated, and Martin Shkreli, CEO of Turing Pharmaceuticals (the drug company that acquired Daraprim and raised its price) was dubbed “the most hated man in America,” by BBC.

    Nonetheless, in February, a group of students from Sydney Grammar, a high school in Sydney, Australia, were given the opportunity to work with University of Sydney’s Alice Williamson, a postdoctoral teaching fellow in the School of Chemistry, and with Open Source Malaria to develop a more economic-friendly generic for Daraprim. The students purchased 17 grams of materials for only $15. Using the patent recipe, the students worked with their science teachers on the drug. According to a Washington Post article, the group “posted all of their work online periodically through Open Source Malaria, which allowed scientists to provide them with guidance and feedback.”

    The group completed their work on the drug in November, and it was taken to be tested at the university. The molecular fingerprint and the crystal’s melting point were found to be complementary to those of Daraprim. According to Dr. Williamson, the drug the students created was a “very pure sample of the medicine… which is a challenge.” The materials the students bought were able to come up with 3.7 grams of Daraprim, which, in the US market, would sell for a little over $100,000.

    Outside of the United States, Daraprim is quite inexpensive. In Australia, for example, 50 pills cost $12.99. According to the Sydney Morning Herald, although the drug is currently not protected by the patent, a loophole called the “closed distribution model” allows Turing Pharmaceuticals to control Daraprim drug sales in the United States. Meaning, if Shkreli does not allow the drug the students created to be tested against Daraprim in order to validate it as a generic, the drug must be tested in new clinical trials, which requires funding.

    Shkreli released a video statement on Monday, December 1, in response to this news. In it, he said, “I’m delighted to hear about more and more students entering the STEM field. These Australian students are proof that the 21st century economy will solve problems of human suffering through science and technology… Medical science has brought tremendous advances in cancer, mental health, autoimmune disorders, and many others. Technology has lowered the costs of a myriad of goods and services dramatically. We should congratulate these students for their interest in chemistry, and I’ll be excited for what is to come in the STEM-focused 21st century.”

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