Sudden drug price increases

GRtak

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Here is an update on what is going on with "Pharma-Bro" and what the Congressional investigations has uncovered in emails.


'Another $7.2 Million. Pow!' A Peek Inside Turing Pharmaceuticals


A memo from congressional investigators sheds new light on the inner workings of Martin Shkreli's Turing Pharmaceuticals after the company jacked up the prices of a decades-old drug used to treat AIDS patients.

The House Committee on Oversight and Investigations is looking into Turing and other drug companies' price increases. This memo, released Tuesday, includes excerpts from the company's internal documents and emails.

It paints a picture of the now-disgraced "pharma-bro" Martin Shkreli giddily rubbing his palms together at the prospect of all the money Daraprim will generate for his fledgling company. The drug is the only cure for toxoplasmosis, a disease that strikes people including AIDS and cancer patients whose immune systems are suppressed.

Turing bought Daraprim last year and jacked up the price 5,000 percent, from $13.50 to $750 a pill.

Here are a few highlights from the data dump.

When Turing agreed to buy Daraprim, company officials went into celebration mode:

"Very good. Nice work as usual. $1bn here we come." ? Turing Chairman Ron Tilles email dated May 27, 2015.

"I think it will be huge. We raised the price from $1,700 per bottle to $75,000 ... So 5,000 paying bottles at the new price is $375,000,000 - almost all of it is profit and I think we will get 3 years of that or more. Should be a very handsome investment for all of us." ? Martin Shkreli email dated Aug. 27, 2015.

"Another $7.2 million. Pow!" ? Tina Ghorban, senior director of business analytics, reacting to a purchase order for 96 bottles at $75,000 a bottle, on Sept. 17.
The company thought it could handle blowback from AIDS activists and doctors:

"HIV patient advocacy may react to price increase ... we still come out ahead if we can frame this issue within the HIV/AIDS community as a fight between a drug company and insurance companies. As long as everyone who needs Daraprim can get it as soon as they need it, regardless of ability to pay, the community should have no issue. There is no love lost between HIV/AIDS activists and insurance companies, and they certainly don't want to be manipulated by them to fight on their behalf."

"Cost and coverage are not obstacles to treatment today ... physicians do not report high out-of-pocket costs, required prior authorizations, or other access barriers to toxo medications."
They were wrong:

"Given your company's recent move to raise the price of pyrimethamine over 5,000% to an incredible $750 a pill, I have decided not to meet with representatives from Turing. ... I am also urging my colleagues here at UNC, as well as at Duke, ECU, Wake Forest and other clinical centers across our state to do likewise, until Turing announces a reasonable and ethical reduction in the price of this important medication ? a drug we rely on most to treat toxoplasmosis." ? an associate professor at the University of North Carolina, Oct. 1.

"After over a week of trying to secure Daraprim for an uninsured patient requiring Daraprim at Massachusetts General Hospital, I need immediate assistance with expediting this case. ... We have been provided with inaccurate/misleading information by the dedicated Daraprim Team. ... This is a critical matter, visible at the highest levels of our Infectious Disease Department." ? Complaint from doctor at Massachusetts General Hospital, Oct. 8.
So Turing went into crisis mode, trying out discount programs and struggling with PR:

"I think we are acting a little like a deer in the headlights, and need to take some action steps now. If a hospital like Mass General is having issues we are in trouble." ? Ed Painter, head of investor relations, Oct. 8.

"Is there an annual price reduction commitment that would discourage generics from entering the market? What if we headlined ...Turing Pharmaceuticals commits to an out of pocket cost to individuals of less than $20." ? Painter, Sept. 26.

"I don't think so. Re reductions ? Think it's best we don't PR something like that unless its something we're willing to commit to doing." ? Patrick Crutcher, director of business development, Sept. 26.

"FYI, we are 'blowing through' copay dollars very fast. ... My opinion is that with the current state of affairs that we should continue to provide to patients, but we'll need to ultimately evaluate this program and understand the effect on margin." Jon Haas, director of patient access, Sept. 29.

"As early as next week, the Board should remove Martin as CEO. ... the price drop has to be significant and tied to something. ... this cannot be seen as something that appears to be as arbitrary as the price hike in the first place." ? Outside PR consultant, Oct. 8.
On Dec. 16, Shkreli was arrested on securities fraud charges. He resigned from Turing the following day.
 

tigger

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He must make it to jail.
Jesus, if only that were possible. Problem is that, far as I've read, he hasn't broken any laws. He's just a fucking scumbag (him and everyone else at Turing.) Which really isn't just an indictment of him, but of our entire for-profit healthcare system.

Turing Consultant said:
... this cannot be seen as something that appears to be as arbitrary as the price hike in the first place.
That single statement is so damning it blows my mind.
 
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GRtak

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There is a post on the previous page that lays out some of his legal wrong doings. Whether or not he will see jail time is still up in the air.
 

nomix

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I hope these people get anal cancer. And that's coming from the son of a cancer survivors.

They're what's wrong with your country, and our culture.
 

Captain_Whine

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I'm actually surprised he came that far in processing.

Usually situations like this getting solved with a single rent-a-cop, who has dangerously sick wife or something. The traditional "what's that in your trunk" case. :rolleyes:
 

LeVeL

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Correct me if I'm wrong, but he is no longer part of Turing, the pharma that produces the drug. So while Shkreli is under investigation for securities fraud and might go to jail for that, it is within the company's power to lower prices, no?


Also, remember when Wu Tang released a single copy of their new album and it was purchased by none other than Shkreli for $2mil iirc? Well, apparently he's not on good terms with Ghostface Killah:

 
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tigger

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There is a post on the previous page that lays out some of his legal wrong doings. Whether or not he will see jail time is still up in the air.
Thanks for reminding me. I'd forgotten about the fraud investigation.
 

LeVeL

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Daraprim is a generic, which means that the patent on the drug?a government-granted monopoly meant to encourage innovation?has expired and the relevant chemical structure (it?s called ?pyrimethamine?) is in the public domain. Anyone could in principle come to market with a pyrimethamine drug identical to Daraprim. So what is it that Shkreli bought when he spent $55 million for the right to sell Daraprim? Easy question. He bought Daraprim?s Food and Drug Administration (FDA) approval.
More
 

_HighVoltage_

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Jesus, if only that were possible. Problem is that, far as I've read, he hasn't broken any laws. He's just a fucking scumbag (him and everyone else at Turing.) Which really isn't just an indictment of him, but of our entire for-profit healthcare system.
Exactly. From what I've read too, and after watching his congressional hearing, I am worried that everyone is focusing on what an asshole he is (which is undisputed), and no one is looking to address the problem with the system that allowed him to do in the first place (and made it legal). Free market capitalism is fine when we are talking about iPhones, but when it comes to life-saving drugs the government should have some power to prevent this from happening in the future.
 

LeVeL

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Exactly. From what I've read too, and after watching his congressional hearing, I am worried that everyone is focusing on what an asshole he is (which is undisputed), and no one is looking to address the problem with the system that allowed him to do in the first place (and made it legal). Free market capitalism is fine when we are talking about iPhones, but when it comes to life-saving drugs the government should have some power to prevent this from happening in the future.
If the government regulatory hurdles didn't take several years and tens of millions of dollars to get drugs simply tested for approval, a competitor would've marketed a similar drug already and prices would've plummeted. In fact, that is exactly what is going to happen once someone gets through the nightmarish regulatory spiderweb.
 

GRtak

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Not always. I have had two different drugs go up in price in the past few years because one company quit producing a drug saying (paraphrased of course) "With the increase in competition, there is no longer enough profit to be made so we are ceasing production". The price increase was not an insignificant amount either. In one case, a monthly supply increased from about $33 a month to $200 a month. Another one doubled in price for an emergency anti allergen.

The sad part is that our government pays for a ton of research that companies get to swoop in and take credit for. They then make huge profits and screw the customers that have to have that medicine.
 

GRtak

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This is in direct relation to the previous post.


Anaphylactic Sticker Shock

Road trip! Or, two middle-aged women go on a Hunter S. Thompson-esque drug-buying spree across an international border. And score.

Well, maybe the trip is more phlegmatic Fred Thompson than gonzo Hunter S. And maybe we scarf grilled veggies and espresso instead of cocaine and booze (although rum will enter the picture), but we do cop drugs.

The adventure began with a rant: ?The last time I bought an EpiPen, it cost $60, and that was too much. Now it?s $380. You?re a reporter. Look into this.? My marching orders came from Mary, a friend whose drugs aren?t covered by insurance. Allergic to bees, she could die of anaphylactic shock if stung. Millions of kids and adults are similarly vulnerable?peanuts, stings, various meds can swell shut their airways. Their lives may depend on a pen-shaped, plastic delivery device for self-injecting a quickacting dose of epinephrine.

?If you balk at the price, you?ll be muttering, ?I wish I?d bought it,? as you breathe your last,? growls Mary. ?The extortionate price is a drop in the bucket of what?s wrong with healthcare.?

Actually, it pretty much sums up the whole rotten bucket. First synthesized in 1904, epinephrine, aka adrenaline, is now a dirtcheap generic. If your doctor prescribed it, says Vermont pharmacist Rich Harvie, you could buy a pre-loaded syringe of epinephrine for under $20. But the more foolproof delivery device?the pen in EpiPen?was patented in 1977, meaning that Mylan, the U.S. marketer, and Pfizer, the manufacturer, have a license to gouge. An EpiPen?s price, says Harvie, ?is ridiculous, just awful.? And since it requires a prescription in the United States, a doctor?s visit can boost the cost.

EpiPens used to be cheap?just $35.59 wholesale in 1986. Harvie now pays $333 for a two-pack?the only option (which, given an 18-month-from-manufacture shelf life, risks waste and reliance on an expired device).

What makes life-and-death EpiPens a poster child for Big Pharma greed is that the industry?s usual excuses for exorbitant pricing don?t apply. R&D costs? The delivery system was developed on the taxpayers? dime by military/NASA engineer Sheldon Kaplan (who never got a penny in royalties) to inject atropine to counter battlefield nerve gas. Minor modifications suited it to epinephrine. Educational/marketing costs? Every doctor already knows about EpiPens. A limited customer base? With allergies on the rise and millions of EpiPens sold globally, economy of scale is built in, and a repeat market is guaranteed by quick expiration and dire need. EpiPen earned Mylan a tidy $640 million in 2012, the New York Times reported.

It is not only brand-name and patented drugs that escalate U.S. healthcare costs. A variety of U.S. generics?whether from coincidence or collusion?cost consumers similarly high prices. ?I?ve seen all the generic [drug] companies raise prices the same 500 percent overnight,? says Harvie.

I tried repeatedly to talk to Pfizer and Mylan to ask why their device costs $360 to $435 retail, but no one would actually speak to me, and all I could extract were emails regurgitating PR gruel.

So back to our excellent adventure. We entered Canada from Vermont via a tiny border crossing and headed to Sutton, Quebec. Hunter S. would have sneered at our bistro lunch and stroll past tr?s charmant tourist shops to Pharmacie Mario Milot & Mathieu B?lisle. ?I?d like to buy an EpiPen,? I told the pharmacist. ?Have you a prescription, madam?? M. Milot asked. ?But I was told it was over-the-counter.? ?Yes, but without [an insurance-backed] prescription, it will be so extremely expensive: US $94.?

To celebrate my pyrrhic victory, I bought a bottle of U.S.-embargoed Cuban rum, stuck it under the drugs and smoked duck, and passed through U.S. customs. I thought of the nice Canadian pharmacist?s sadness at my having to fork out $94?until I told him how much more EpiPens cost only 10 miles south. ?But why?? he asked. Good question, monsieur.

I?ll go out on a limb and say greed, or, as a pharma-shill stoned enough on samples to be honest would admit: ?Whatever the market will bear,? or ?Because we can, suckers.? And if people are forced to rely on expired EpiPens, or do without? Well, that?s the way the U.S. healthcare system?and the peanut-allergic kid?crumbles.

High price of EpiPens spurs consumers, EMTs to resort to syringes for allergic reactions

Millions of people with severe allergies carry EpiPens to reverse life-threatening allergic reactions. But as the prices of these auto-injectors have soared, more than quintupling since 2004, many emergency medical responders ? and some regular families ? are turning to manual syringes as a cheaper alternative.

That?s raising concern among some doctors and patient advocates, who warn that it?s more complicated to get the correct dose and administer it safely with a syringe.

?Anyone using this approach would require extensive medical training to do it effectively and safely, without contamination or accidental intravenous injection,? said Dr. James Baker, Jr., the CEO and chief medical officer of Food Allergy Research & Education. The organization?s corporate sponsors include Mylan, which manufactures the EpiPen, and Sanofi, which used to sell a competitor.

Amie Vialet De Montbel felt that she didn?t have a choice but to try the syringe.

Her 12-year-old son is so allergic to milk that he wears a mask when he goes out in public. Last month, when she filled his prescription for two 2-packs of EpiPens ? one to take to camp, and one for home ?the cash register rang up a charge of $1,212.

?I was in absolute shock,? said Vialet De Montbel, who lives in Troy, Va. ?I don?t even pay that much for my mortgage.? She has health insurance with a $4,000 deductible, so she would have had to pay the whole sum out of pocket. She didn?t buy the EpiPens.

At the doctor?s office the next day, a nurse told Vialet De Montbel something she had never heard before: For about $20, she could buy a couple of glass ampules of epinephrine and regular syringes from a local pharmacy, and get the syringes filled with the epinephrine at a doctor?s office. They would expire in about three months, whereas EpiPens last about a year, but they could save her more than $1,000. She plans to get the syringes soon.

Meanwhile her older son, age 15, is ?carrying expired EpiPens because I can?t afford to get him [new ones] right now,? she said.

EpiPens ? spring-loaded syringes filled with epinephrine ? are widely carried by people with life-threatening allergies. Over 3.6 million prescriptions for EpiPen kits were written last year, and another half-million for other similar products, according to data provided by IMS Health.

Some states require schools to stock EpiPens. Emergency medical technicians who aren?t certified to give regular injections often carry them as well.

Emergency medical providers have been talking about the rising cost of EpiPens for the past few years, said Dr. Peter Taillac, chair of the medical directors council of the National Association of State EMS Officials.

?They cost too damn much,? Taillac said.

Mylan has raised the list price of EpiPens over 450 percent since 2004, after adjusting for inflation, according to data provided by Elsevier?s Gold Standard Drug Database. A pack of two EpiPens cost about $100 in today?s dollars in 2004. The list price now tops $600. Some emergency medical services buying directly from medical supply companies pay even more ? upwards of $900 for a pack of two.

The company said the price increases over time ?reflect the multiple, important product features and the value the product provides,? but declined to provide specifics about those features.

There are some competitors to EpiPen, but they haven?t caught on. The primary competitor, Auvi-Q, sold by Sanofi, was taken off the market in October 2015 because some of the devices weren?t dispensing the proper amount of medication.

A similar device, the Adrenaclick, was prescribed just a few hundred times last year, and a generic version was prescribed about 183,000 times, according to data from IMS Health. Since that device isn?t considered by the Food and Drug Administration as therapeutically equivalent to the EpiPen, it can?t be substituted when filling a prescription.

Teva Pharmaceutical Industries applied to market a generic EpiPen, but the application was rejected by the FDA earlier this year.

?The price of the auto-injector has become a real issue, particularly for the small rural agencies,? Taillac said.

The high cost has driven officials in at least 10 states ? including Colorado, Maryland, and South Carolina ? to push for training more EMTs to give epinephrine injections using regular syringes.

One of those agencies is the Broadlands-Longview Fire Protection District in Central Illinois, which uses all volunteer firefighters. Jim Jones, a district official, said his district has two fire stations, seven vehicles, and eight EpiPens. Those EpiPens alone cost the district about $2,400 a year, or 3 percent of its total operating budget.

Switching to regular syringes, Jones said, would save at least $2,200, which could pay for emergency medical technician training for five firefighters.

?That?s huge,? Jones said. ?So I can spend the money educating our firefighters as opposed to buying EpiPens.?

Jones asked Illinois state Senator Chapin Rose to sponsor a bill to expressly allow first responders to administer epinephrine from a vial rather than an EpiPen. Rose estimated it could save hundreds of thousands of dollars for his district, and millions for the state. ?It seems like we could do a heck of a lot of good with this change,? said Rose, a Republican.

The bill passed the House and Senate and is awaiting the governor?s signature.

Meanwhile, first responders in Seattle have developed a kit to use in place of EpiPens to save money. King County EMS began using the kits, which contain instructions, an epinephrine vial, and a syringe, in 2013. By now, they?ve replaced about 950 of their 1000 EpiPens with the kits, according to Jim Duren, professional standards manager for King County EMS.

They also sell the kits sans epinephrine, at $15 each, to other public health agencies. Kits from King County have made their way into Alaska, Montana, Oregon, Utah, and Wyoming, Duren said.

Duren said that in the first year, his county saved more than $150,000. In New York, a pilot program with similar kits is estimated to save more than $1 million, if implemented statewide, said Dr. Jeremy Cushman, one of the program?s leaders. In September, the New York team will seek approval to expand.

The Asthma and Allergy Foundation of America finds the trend troubling. It recommends that everyone ? parents, patients, and emergency responders ? use epinephrine auto-injectors, not regular syringes.

?It?s fast, you don?t need to think, [and] it provides a measured dose,? said Dr. Cary Sennett, president and CEO of the foundation. The foundation has business relationships with many pharmaceutical firms, including Mylan and Sanofi.

But Dr. Richard Lockey, a professor at the University of South Florida who has been an allergy doctor since the 1970s, said some patients have always preferred syringes over the branded EpiPens and predicted that rising prices will likely prompt more to make that choice. He estimates that 1 out of every 6 of his patients chooses the regular syringes.

As long as patients are educated about how to use the syringes, he said they?re ?99 percent as good? as the EpiPens. ?Is that ideal? Well, no, not necessarily,? he said. ?It?s better to have an auto-injector, yes.?

But Lockey said syringes make sense for patients who can?t afford the EpiPen. ?Everyone wants to drive around in a Cadillac,? he said, ?but not everybody does.?

This story was updated to include a comment from Mylan.
 
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