Martin Shkreli may get competition for his pricey drug, after all
October 22, 2015 | Antitrust, Compound Pharmacies, FDA, FTC, Pricing & Patient Access, Uncategorized
By Ed Silverman

Thanks to a compounding pharmacy, Martin Shkreli’s company may no longer have a lock on the market for its pricey anti-infective drug Daraprim.

A little-known company called Imprimis Pharmaceuticals announced plans to make a combination medicine that includes pyrimethamine, the same active ingredient found in Daraprim. And Imprimis intends to charge just $99 for a bottle of 100 capsules, or about $1 each. Daraprim costs $750 per tablet. Read More


How to decide if a cancer drug is worth the cost NCCN’s Carlson explains
October 22, 2015 | Cancer, Pricing & Patient Access, Uncategorized
By Ed Silverman

The clamor over prescription drug pricing often implies that medicines simply cost too much. But many experts say the debate can easily overlook an important point – is a given treatment really worth the price? To help payers, physicians, and consumers answer this question, the National Comprehensive Cancer Network, a non-profit that develops treatment guidelines, has developed a new tool called Evidence Block to assess whether medicines are affordable in the context of overall cancer care. We spoke with Robert Carlson, the NCCN chief executive, about its approach and its hopes for helping patients make important decisions. This is an edited version… Read More


Pharmalot.. Pharmalittle.. We’re catching up on Gilead, Theranos and…
October 22, 2015 | Cancer, Counterfeit Medicines, FDA, Laboratory Tests, Layoffs, Litigation, Marketing, Mergers and Acquisitions, Uncategorized
By Ed Silverman

Top of the morning to you. And another fine one, it is. The sun is shining, the Pharmalot campus is blissfully quiet and more cups of stimulation are brewing in the Pharmalot cafeteria. All of which means that we are in the midst of yet another busy day. No doubt, you can relate. So time to dig in to the usual routine and, to help you along, we have assembled a few items of interest. Good luck, today, and of course, do keep in touch...

Theranos ceo Elizabeth Holmes plans to release a 16-page point-by-point rebuttal to articles in The Wall Street Journal that questioned the accuracy of its blood tests and the extent to its unique technology is used; Oh, say, can you see? An Illinois businessman is angry because his display of patriotism was removed from ads for a new cancer drug that are being run by Bristol-Myers Squibb; and Gilead Sciences is now known to be developing an experimental drug for Ebola after a London hospital revealed that the treatment had been given to a nurse who had been readmitted with the illness. Read More


Do prescription drug prices worry you? Join our Twitter chat and discuss
October 21, 2015 | Pricing & Patient Access
By Ed Silverman

Some drug makers are buying medicines from other companies and jacking up prices by 200, 500 and even 5,000 percent. New cancer treatments are so expensive that oncologists plan to petition the Obama administration to haggle over purchases. And even the costof some generic drugs – which are supposed to help lower health care bills – rose recently. Everywhere you look it seems that prescription drug prices are a controversial – and urgent – topic. Read More


Valeant denies short seller report that bludgeoned its stock
October 21, 2015 | Pricing & Patient Access, Uncategorized
By Ed Silverman

The Valeant Pharmaceuticals story is going from bad to worse. The latest installment involves accusations by an influential short seller that the drug maker, which is already under investigation for its pricing and patient assistance programs, is exploiting ties to a specialty pharmacy to inflate revenue.

The claim was made in a report issued this morning by Citron Research, which describes a complicated process used by Valeant to ensure prescriptions are filled. At one point, the report, which likened the Valeant saga to the Enron scandal more than a decade ago, wiped out nearly $20 billion in the value of Valeant stock. The shares already lost one third of their value this year. Read More


Pharmalot.. Pharmalittle.. We’re catching up on Pharma lobbying, Biogen and…
October 21, 2015 | AIDS, Alzheimer's, Antibiotics, Bribes, Compound Pharmacies, FDA, Hepatitis C, Legislation, Patents, Pricing & Patient Access, Research & Development, Uncategorized
By Ed Silverman

Good morning, everyone, and how are you today? We are just fine, thank you. In fact, we are thrilled to report that we have made it to the middle of the week. This is the sort of accomplishment that calls for a cup of stimulation and, as always, we invite you to join us. It may be needed to get to the end of the week, after all. Meanwhile, here are some tidbits. Hope you conquer the world today and do keep us in mind when you run across anything juicy...

The 21st Century Cures Act has garnered an unusually broad range of support and one reason is that lawmakers softened up the usual opponents of looser rules with a big carrot — billions of dollars in new funding for the NIH; Biogen plans to cut about 11 percent of its workforce of 7,550 employees and end some development programs in a restructuring aimed at saving $250 million a year; the Indian Patent Office has denied a patent to Boehringer Ingelheim for key HIV drug, Viramune XR, yet again thwarting attempts by big drug makers to gain an "exclusivity" extension and block affordable generics; and a nurse who admitted taking $83,000 in kickbacks from Insys Therapeutics, which makes the Subsys painkiller, was pressured by sales reps to increase her prescribing so Subsys sales would also increase. Read More


How High? The backlash over prescription drug prices rolls onward
October 20, 2015 | FDA, FTC, Generics, Pricing & Patient Access
By Ed Silverman

The backlash over prescription drug prices shows no sign of abating. Just take a look at a few developments over the past several days. Hillary Clinton wrote letters to the FDA and FTC asking them to investigate. Marco Rubio said some pricing practices amount to “pure profiteering,” And Bernie Sanders continues to dump on drug makers.

The remarks, which really reflect, popular angst, may be having an effect. Valeant Pharmaceuticals, which has been lambasted for buying medicines and then jacking up prices to sky-high levels, plans to find a buyer for one business unit that has depended on price hikes for growth. And biotech investors are worried. When a Bain Capital hedge fund invested in Spark Therapeutics, the bet was the company would win approval of the first gene therapy in the US and command a premium price. But charging hundreds of thousands of dollars per patient may no longer be a sure thing. Read More


Do prescription drug prices worry you? Join our Twitter chat and discuss
October 20, 2015 | Pricing & Patient Access, Uncategorized
By Ed Silverman

Some drug makers are buying medicines from other companies and jacking up prices by 200, 500 and even 5,000 percent. New cancer treatments are so expensive that oncologists plan to petition the Obama administration to haggle over purchases. And even the costof some generic drugs – which are supposed to help lower health care bills – rose recently. Everywhere you look it seems that prescription drug prices are a controversial – and urgent – topic.

So let’s chat about this. On Wednesday, Nov. 4 from 1-2 p.m. ET, we will hold a Pharmalot Twitter Chat – and our topic will be prescription drug pricing. Join us using #pharmalotchat And our special guest host will be Peter Bach, a physician who heads the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center in New York – and who developed an interactive calculator to compare the value of different cancer meds. Read More


What warning letter? Amid free speech battle, FDA yanks Pacira letter
October 20, 2015 | FDA, Litigation, Marketing, Uncategorized
By Ed Silverman

It’s not every day that the Food and Drug Administration removes a warning letter from its web site. But the agency did just that recently when it pulled down a missive that was originally sent last year to Pacira Pharmaceuticals. And the removal comes just as a closely watched legal battle – which, in part, turns on First Amendment rights – heats up between the drug maker and the agency.

Indeed, as unusual as it is for the FDA to remove a letter, what makes this still more interesting is that it occurs amid a lawsuit Pacira filed recently accusing the FDA of overstepping its authority to thwart inappropriate marketing. Read More


The problem with using surrogate markers to approve cancer drugs
October 20, 2015 | Cancer, Clinical Trials, Drug Development, FDA, Uncategorized
By Ed Silverman

In 2003, the FDA approved a lung cancer drug called Iressa, but not because the medicine helped patients live longer. Instead, the agency endorsed the drug based on the fact that it reduced the size of tumors in about 10 percent of patients. This “surrogate” measure was expected to predict future increases in survival time. But it didn’t. A subsequent trial found that Iressa did not prolong patient lives. And in 2012 — after nearly a decade on the market at a cost to the US health care system of around $285 million — the FDA, at the manufacturer’s request, revoked the drug’s approval.

This is a cautionary tale of what can happen when regulatory decisions are based on proxy measures without proof that drugs are extending lives. In the case of Iressa, the FDA eventually corrected course and pulled the ineffective drug. But a new study suggests that many more cancer agents of questionable benefit remain on the market — even as Congress is debating a bill that would increase use of surrogate measures to approve drugs. Read More