Collector Search Failed Trial Edition Expired Medication
012418by admin

Collector Search Failed Trial Edition Expired Medication

In some countries, such as (photo) and, more than 20% of all drug sales are generic. A generic drug is a that is equivalent to a brand-name product in dosage, strength, route of administration, quality, performance and intended use, but does not carry the brand name. The generic drug may differ from the original in non-essential characteristics such as color, taste and packaging. Although they may not be associated with a particular company, generic drugs are usually subject to government regulations in the countries where they are dispensed. They are labeled with the name of the manufacturer and a generic nonproprietary name such as the or of the drug. A generic drug must contain the same as the original brand-name formulation.

The (FDA) requires that generics be identical to, or within an acceptable range of, their brand-name counterparts with respect to and properties. (The FDA's use of the word 'identical' is a, not literal.) such as differ biologically from drugs. Generic versions of these drugs, known as, are typically regulated under an extended set of rules. In most cases, generic products become available after the afforded to a drug's original developer expire. Once generic drugs enter the market, competition often leads to substantially lower prices for both the original brand-name product and its generic equivalents. In most countries, patents give 20 years of protection.

Latest breaking news, including politics, crime and celebrity. Find stories, updates and expert opinion. Compaq Presario V6000 Drivers Windows Xp Sp3.

Collector Search Failed Trial Edition Expired MedicationCollector Search Failed Trial Edition Expired Medication

However, many countries and regions, such as the European Union and the United States, may grant up to five years of additional protection ('patent term restoration') if manufacturers meet specific goals, such as conducting for pediatric patients. Manufacturers, wholesalers, insurers, and drugstores can each increase prices at various stages of production and distribution. In 2014, according to an analysis by the Generic Pharmaceutical Association, generic drugs accounted for 88% of the 4.3 billion prescriptions filled in the United States.: 2.

See also: Generic drug names are constructed using standardized that distinguish drugs between and within classes and suggest their action. Economics [ ] When a pharmaceutical company first markets a drug, it is usually under a patent that, until it expires, the company can use to exclude competitors by suing them for patent infringement. Pharmaceutical companies that develop new drugs generally only invest in drug candidates with strong patent protection as a strategy to recoup their costs to (include the costs of the drug candidates that fail) and to make a profit. The average cost to a brand-name company of discovering, testing, and obtaining regulatory approval for a new drug, with a, was estimated to be as much as $800 million in 2003 and $2.6 billion in 2014. Drug companies that bring new products have several strategies they use to extend their exclusivity, some of which are seen as gaming the system and referred to by critics as ', but at some point there is no patent protection available. For as long as a drug patent lasts, a brand-name company enjoys a period of market exclusivity, or, in which the company is able to set the price of the drug at a level that maximizes profit.

This profit often greatly exceeds the development and production costs of the drug, allowing the company to offset the cost of research and development of other drugs that are not profitable or do not pass clinical trials. Large pharmaceutical companies often spend millions of dollars protecting their patents from generic competition. Apart from litigation, they may reformulate a drug or license a subsidiary (or another company) to sell generics under the original patent. Generics sold under license from the patent holder are known as. Generic drugs are usually sold for significantly lower prices than their branded equivalents and at lower. One reason for this is that competition increases among producers when a drug is no longer protected by patents.

Generic companies incur fewer costs in creating generic drugs—only the cost of manufacturing, without the costs of and —and are therefore able to maintain at a lower price. The prices are often low enough for users in less-prosperous countries to afford them. For example, Thailand has imported millions of doses of a generic version of the blood-thinning drug (used to help prevent heart attacks) from India, the leading manufacturer of generic drugs, at a cost of 3 US cents per dose. Generic drug companies may also receive the benefit of the previous marketing efforts of the brand-name company, including advertising, presentations by drug representatives, and distribution of free samples. Many drugs introduced by generic manufacturers have already been on the market for a decade or more and may already be well known to patients and providers, although often under their branded name.

[ ] In the United Kingdom, generic drug pricing is controlled by the government's reimbursement rate. The price paid by pharmacists and doctors is determined mainly by the number of license holders, the sales value of the original brand, and the ease of manufacture. A typical price decay graph will show a 'scalloped' curve, which usually starts at the brand-name price on the day of generic launch and then falls as competition intensifies. After some years, the graph typically flattens out at approximately 20% of the original brand price. In about 20% of cases, the price 'bounces': Some license holders withdraw from the market when the selling price dips below their cost of goods, and the price then rises for a while until the license holders re-enter the market with new stock. In 2012, 84% of prescriptions in the US were filled with generic drugs, and in 2014, the use of generic drugs in the United States led to $254 billion in health care savings.: 2 In the mid 2010s the generics industry began transitioning to the end of an era of giant in the pharmaceutical industry; patented drugs with sales of around $28 billion were set to come off patent in 2018, but in 2019 only about $10 billion in revenue was set to open for competition, and less the next year. Companies in the industry have responded with or turning to try to generate new drugs.

Regulation [ ] Most nations require generic drug manufacturers to prove that their formulations are bioequivalent to their brand-name counterparts. Bioequivalence does not mean generic drugs must be exactly the same as the brand-name product ('pharmaceutical equivalent').

Chemical differences may exist; a different or may be used, for instance. However, the therapeutic effect of the drug must be the same ('pharmaceutical alternative'). [ ] Most small molecule drugs are accepted as bioequivalent if their parameters of (AUC) and (C max) are within a 90% of 80–125%; most approved generics are well within this limit. For more complex products—such as,,, or biosimilar drugs—demonstrating pharmacodynamic or clinical equivalence is more challenging. United States [ ] Enacted in 1984, the, informally known as the Hatch-Waxman Act, standardized procedures for recognition of generic drugs. In 2007, the FDA launched the (GIVE): an effort to modernize and streamline the generic drug approval process, and to increase the number and variety of generic products available. Before a company can market a generic drug, it needs to file an (ANDA) with the Food and Drug Administration, seeking to demonstrate therapeutic equivalence to a previously approved 'reference-listed drug' and proving that it can manufacture the drug safely and consistently.

For an ANDA to be approved, the FDA requires the bioequivalence of a generic drug to be between 80% and 125% of the innovator product. (This range is part of a statistical calculation, and does not mean that generic drugs are allowed to differ from their brand-name counterparts by up to 25 percent.) The FDA evaluated 2,070 studies conducted between 1996 and 2007 that compared the absorption of brand-name and generic drugs into a person’s body. The average difference in absorption between the generic and the brand-name drug was 3.5 percent, comparable to the difference between two batches of a brand-name drug. Non-innovator versions of biologic drugs, or biosimilars, require clinical trials for in addition to tests establishing bioequivalency. These products cannot be entirely identical because of batch-to-batch variability and their biological nature, and they are subject to extra rules.

When an application is approved, the FDA adds the generic drug to its list and annotates the list to show equivalence between the reference-listed drug and the generic. The FDA also recognizes drugs that use the same ingredients with different bioavailability, and divides them into therapeutic equivalence groups.

For example, as of 2006, had four equivalence groups, all using the same active ingredient, but considered equivalent only within each group. In order to start selling a drug promptly after the patent on innovator drug expires, a generic company has to file its ANDA well before the patent expires. This puts the generic company at risk of being sued for patent infringement, since the act of filing the ANDA is considered 'constructive infringement' of the patent.

In order to incentivize generic companies to take that risk the Hatch-Waxman act granted a 180-day administrative exclusivity period to generic drug manufacturers who are the first to file an ANDA. When faced with patent litigation from the drug innovator, generic companies will often counter-sue, challenging the validity of the patent. Like any litigation between private parties, the innovator and generic companies may choose to settle the litigation.

Some of these settlement agreements have been struck down by courts when they took the form of agreements, in which the generic company basically accepts a payment to drop the litigation, delaying the introduction of the generic product and frustrating the purpose of the Hatch-Waxman Act. Innovator companies sometimes try to maintain some of the revenue from their drug after patents expire by allowing another company to sell an; a 2011 FTC report found that consumers benefitted from lower costs when an authorized generic was introduced during the 180 day exclusivity period, as it created competition. Rags Game Password Crack. Innovator companies may also present arguments to the FDA that the ANDA should not be accepted by filing an. Main article: The began encouraging more drug manufacturing by Indian companies in the early 1960s, and with the Patents Act in 1970. The Patents Act removed composition patents for foods and drugs, and though it kept process patents, these were shortened to a period of five to seven years. The resulting lack of patent protection created a niche in both the Indian and global markets that Indian companies filled by reverse-engineering new processes for manufacturing low-cost drugs.

The code of ethics issued by the in 2002 calls for physicians to prescribe drugs by their generic names only.

Unless you have multiple myeloma, a rare and vicious cancer of the blood, chances are you haven’t heard of Revlimid. The immunomodulatory drug slows the growth of new blood vessels, and it’s a product of the kind of ingenuity and daring that once made the pharmaceutical industry among the most respected in America.

It’s also a handy stand-in for everything that’s wrong with the business today. In the early 1990s, researchers at Boston Children’s Hospital stumbled on an old sedative that appeared to slow the progress of myeloma. The drug, thalidomide, was. It had been prescribed widely for morning sickness in the 1950s, but caused thousands of horrific birth defects. Still, nothing had ever been as effective against multiple myeloma, so a biotechnology company called Celgene took a risk and spent millions of dollars developing an analogue of the compound, transforming thalidomide into a more potent cancer drug. It worked: When the FDA approved Revlimid to treat meyloma in 2006, it revolutionized the cancer's treatment.

Average survival time jumped from three or four years in the late ’90s to almost a decade today. “There’s not one other disease where you can say we tripled survival in that period of time,” says Mohamad Hussein, Celgene’s head of scientific affairs. Through calculated risk and dedicated bench work, Celgene had turned poison into gold.

The story of Revlimid’s development is unique, even uplifting. But the story of what it costs is all too familiar. In the past decade, the drug’s price jumped from $78,000 a year to $156,000. Last year, the median myeloma patient on Medicare—a person supposedly shielded from extortionate drug prices—paid $11,538 out of pocket each year for the medication. (A majority of American families.) Revlimid has produced at least $20 billion in revenues since its release, but Celgene, and all pharmaceutical companies, say they need high prices to continue developing lifesaving medications. “You get what you pay for,” Hussein says.

The 25-milligram pill encapsulates everything that’s great and everything that’s terrible about the US pharmaceutical industry. In the past five years, the price of brand-name prescription drugs has doubled; cancer drugs, specifically, have gone up by a multiple of six since 2000. Several promising new myeloma drugs have recently been released, including a new and improved follow-up treatment to Revlimid called Pomalyst.

Each drug costs more than $150,000, and Pomalyst comes in over $195,000. “This is not a sustainable model,” says Brian Bolwell, chairman of the Taussig Cancer Institute at the Cleveland Clinic.

Many doctors and patients across the country would agree. So, at a moment when Congress and the Trump administration are grappling with revamping the entire health care economy, we should ask ourselves: How much should a drug actually cost, anyway? Grant Cornett for WIRED It’s a strangely subversive question and one that Steve Pearson, an unassuming internist turned Harvard lecturer turned nonprofit chief, thinks he can answer. Pearson is one of the few people in this country who’ve had any luck getting the prices for individual drugs under control. The nonprofit he founded, the Institute for Clinical and Economic Review (known as ICER), has one purpose—to figure out whether a new drug is worth the price tag or if Big Pharma is taking us for a ride.

For the most part, Pearson says, Americans have no idea what they should be paying for medication. We don’t how much it costs to actually develop a drug; the FDA doesn’t require comparative effectiveness studies, so we don’t know if new drugs work better than existing competitors; and we have little information about how much other consumers are paying for the same products. “Patients in America are getting great value for drugs—and we're getting ripped off,” Pearson says. “The problem is we’ve had little way of knowing when it's one or the other.” President Donald Trump has said that the pharmaceutical industry is and that he wants to let Medicare negotiate with drug companies over the prices we pay—something that was forbidden in 2003, part of a compromise with the politically potent industry to get the Medicare drug expansion plan passed. (Since 1998, Big Pharma has spent more on lobbying than any other industry.) In The Art of the Deal, Trump says that you have to “know when to walk away from the table.” But Medicare—which covers some 57 million people—essentially can’t decline any drug the FDA approves, at least for serious diseases like cancer. It can’t walk away from the table.

Furthermore, the agency doesn’t have any more comparative data than you or I do. When one party in a deal knows more about the goods than the other, economists call it.

It’s a classic recipe for market failure and, as any seasoned negotiator knows, a great way to get a bad deal. Pearson, with ICER, has taken it upon himself to fix this information imbalance, to generate the missing data and calculate a “fair price” for drugs. The team’s efforts involve a forensic approach to dozens of scientific studies and a Vulcan-eyed look at how we value human life and decide to allocate resources. It is straightforward yet radical work—a missing puzzle piece in the effort to solve our drug-pricing crisis.

The Centers for Medicare and Medicaid Services recognized this last spring, when they floated the idea of using ICER’s calculations if Congress ever let them negotiate prices. Pharma-backed groups acknowledged this when they launched a blitz to discredit the group last year. And so far, Pearson’s method has successfully checked the prices of a handful of drugs—something very few people can say they’ve done. But as sensible as the exercise may look in a PowerPoint presentation, some of the people Pearson is trying to help aren’t buying in.

“The new drugs are awesome,” says Matt Goldman, a myeloma patient in Long Beach, California, but if ICER were to decide his meds are overpriced, “our insurance company is going to read this and they’re going to start denying benefits—these are life and death decisions.” Nick Van Dyk, a patient who credits Revlimid with keeping him alive, is more succinct. “I’m talking to you instead of pushing up dirt because of Big Pharma,” he says.

“The ICER guy is a smug, rotten scumbag.” Cold-Blooded Math Figuring out if a drug is priced fairly is not a simple process. One of the first things you have to do is put a value on human life.

So what’s a year of feeling healthy worth? Based on data from the World Health Organization and other sources, ICER puts the value of a quality-adjusted life year in the United States at between $100,000 and $150,000. The money you spend on overpriced drugs, he argues, is money that doesn’t go to your kid’s school or the ambulance driver or fire department. “There are choices within the health care system: Should we get this machine or pay another doctor?” he says. “Then, step back and it’s: Another hospital or 10,000 more teachers?” Pearson’s office in ICER’s downtown Boston headquarters is spare and unlived-in when we meet in August. He spends most of his time in DC; his family lives there, and he’s a visiting scientist at the National Institutes of Health. But Boston is ICER’s home, he says, across the river from Harvard, where Pearson is a lecturer and where he founded the institute back in 2007.

In conversation, Pearson is even-keeled and reassuring—like a doctor walking you through a mixed prognosis. Goateed and with tortoiseshell, geek-chic glasses, he’s wearing cufflinks embossed with the crest of the Royal College of Physicians, where he’s an honorary fellow. (His CV is a grab bag of elite institutions and includes a Stanford undergraduate degree, a master’s from Harvard, and an MD from UC San Francisco.) With his staff of 24 doctors and policy wonks, he aims to put out about nine reports a year, covering dozens of treatments. That day, the ICER staff was meeting to try to figure out a fair price for a new batch of lung cancer medications. The first step is to look at how each of the new drugs rank against the others, which for the most part has never been done. To do it, the team collects clinical trial data and calls up pharmaceutical companies, patients, and doctors.

Then it evaluates all of the published data on each drug under consideration—including findings that sometimes contradict each other—and sticky variables, like study size and design and quality. The staffers rank the magnitude of each drug’s benefits versus its competitors. It’s a rigorous, systemic process, and one that requires the team to make judgment calls about the quality of the data and evidence they’re diving into. “We are trying to fill a real gap in our health care system,” Pearson says. In nearly every other industrialized nation, assessments like these are handled by a government agency.

In Britain, where I sat in on an evaluation meeting, it’s done by the National Institute for Health and Care Excellence, known by its more Orwellian acronym, NICE. NICE is a for opponents of nationalized health care, but its existence is critical to keeping drug costs down in the UK. The agency does all the work ICER does—the work the US government declines to do—but unlike ICER, NICE heavily influences the selection and purchasing of the medications Britons can receive. Pearson spent a year as a NICE fellow in 2005 and found their work inspiring.

At the evaluation meeting I observed, drug manufacturers pled the case for their treatments, and commissioners grilled them over efficacy and price. This kind of official bargaining results in good deals: Europeans pay about half as much for drugs as Americans. But the negotiations only work because regulators are willing to walk away and say no to treatments.

For certain patients in the UK, for instance, NICE delayed for years the approval of Revlimid, that lifesaving myeloma drug, because of cost. “What the Brits acknowledged is that there is a price of life,” Amanda Adler, a Cambridge physician who chaired the NICE meeting, told me afterward. “The government has an obligation to the taxpayer to only pay for stuff that actually works. It also has an obligation to the taxpayer to only pay for stuff that reflects good value for the money.” For everyone’s sake, Adler says, NICE must make that call—even when British headline writers routinely blast the agency for denying access to new drugs. “NICE might see a new treatment that’s twice as good as anything we have, but we might say no if the company wants to charge ten times what already exits,” she says. Pearson doesn’t think America will ever be home to an agency with as much power as NICE, but tackling these profoundly difficult ethical issues has, he believes, “a nobility and a grandeur.” Deep Discounts The first time ICER recommended a price for a drug was in 2014.

The pharmaceutical company Gilead had come out with a new treatment for Hepatitis C, an expensive, grueling ailment that beats down its victims for decades and eventually causes liver failure. The new drug, called Sovaldi, was a 12-week daily course of pills—and it cured the infection. It was one of the most exciting new medications to come around in a generation. Gilead’s list price was $1,000 per pill, or $84,000 for a full course. (Though they did give discounts to Medicaid and the VA.). As reasonable as $84,000 or even $94,500 might seem, there are 3.3 million Hepatitis C patients in the US, and insurers and Medicare didn’t have a spare $277 billion sitting around to cure them all.

There was no way the country’s free-market health care system could ensure that everyone who needed the drug would get it. For society to be able to absorb the costs without cutting back on other health care spending, ICER said, Gilead would have to cut the price of its newest pill, Harvoni, by half to two-thirds. It was the first time ICER had recommended a specific price for a treatment.

“It blew people’s minds,” Pearson says. The next year, after intense pressure, Gilead took 46 percent off the list price for Sovaldi and Harvoni. The price drop was stunning.

Steve Miller, the chief medical officer of Express Scripts, the largest of the middleman firms that buy drugs wholesale for insurance companies, said ICER’s work had given him the ammo he needed to negotiate with Gilead. Overnight, the tiny nonprofit became an implausible power player in the national conversation about drug pricing. Pharma is not happy about this. And if your business model was based on information asymmetry, you wouldn’t be either. Big Pharma, Big Bets “It’s so easy to vilify Pharma,” Diana Brainard says on the day I stopped by to hear Big Pharma’s side of the Solvadi story. “It’s like shooting fish in a barrel.” A physician by training, Brainard is the vice president of clinical research at Gilead. We’re at the company’s campus in Foster City, California, about 20 miles south of San Francisco, where the grounds sprawl over several acres; the upper floors of Gilead’s 30-plus buildings have views of the ugly brown mudflats that line the South Bay.

The place is a maze of construction and new buildings. The people at Gilead and Celgene and other pharmaceutical companies know how we feel about them. America’s relationship with one of its most successful industries is, well, complicated: We distrust their motivations, even as we demand they save our lives. Pharma has a paltry 28 percent favorability rating right now, the same as the federal government. But the scorn isn’t always merited, Brainard says.

Gilead, after all, has spent nearly 30 years trying to find treatments for HIV, and more recently for Hepatitis C. Its success with that disease came from a combination of in-house research and a daring gamble. In 2011 Gilead spent $11 billion acquiring a tiny biotech outfit called Pharmasset.

The company had a compound that showed signs of stopping one type of Hepatitis C in Stage II clinical trials. Gilead’s scientists were thrilled by the acquisition. Outside analysts were not. Spending that much money on an “unproven asset” was ridiculous, one financial analyst wrote. “Our stock plummeted,” says Brainard, who led the company’s clinical trials on its Hepatitis C drugs. “There were clips of Jim Cramer saying, ‘Gilead is filled with fucking morons.’ People thought this was the stupidest decision ever.”. But the bet paid off.

Gilead’s chemists combined Pharmasset’s molecule with one they had been developing, and the results were stunning. “Most chemists don’t ever get to be a part of something like this,” John Link, the company’s vice president for medicinal chemistry, says as he shows me around one of the company’s labs. Link, who is balding and clean cut from the front but maintains a six-inch-long patch of hair in the back, like a very neat mullet in miniature, led the effort to develop the in-house molecule. In total, his team tested thousands of different molecules before they found ones that worked.

“As a chemist in medicine, our intent is to do something good,” Link says. “We’ve done that here.” Gilead had indeed created something momentous. Previous treatments for Hep C were ineffective, cost more than $70,000 per course and came with awful side effects. “You had to take it for a year and it could kill you and it was horrible and it didn’t work,” Brainard says.

“Well, let’s price ours the same as that—and it actually works. And it has no side effects. That’s not evil.

That’s very different from somebody taking a generic and jacking it up.” True, though Solvaldi was originally supposed to cost much less. As its release date neared, according to a Senate investigation into the drug’s costs, Gilead executives pushed the number higher and higher until it had more than doubled. (Gilead disputes that investigation’s findings.). The company's rationale, according to emails disclosed during the investigation, was that if they priced their first Hep C drug super high, they could price their next two Hep C drugs—which were already far along in the pipeline, and looked to be more effective—even higher. From a business perspective, it made no sense for Gilead to charge less for a drug if there was, in fact, a higher price that the market would bear.

Gilead would stick with a $1,000 per pill price “whatever the headlines,” one VP wrote in an email. Senate investigators say the company was fully aware its pricing would put the drug out of reach for many patients. Not coincidentally, that price sent Gilead’s share price soaring.

Furthermore, every pharmaceutical company would argue that high prices drive innovation—that these prices are a necessary and worthy way to spend our limited dollars. Drug company executives like to cite the industry-funded Tufts Center for the Study of Drug Development, which determined in 2014 that it costs, on average, $2.6 billion to bring a single new drug to market. The industry needs resources to pour back into research and development, proponents say. Plenty of people push back on this—advocacy groups and academics question the Tufts Center number and Harvard’s Aaron Kessielheim says the industry devotes 10 to 20 percent on R&D, and 20 to 40 percent of revenue to advertising. “There’s no connection between R&D spending and prices,” he says. But it’s undeniable that, though there are hundreds of biotechnology and pharmaceutical companies in the US, each trying to make new products, nine out of 10 drugs in development fail and only 22 made it to market last year. I ask Brainard what she thinks of Gilead’s pricing for its cure and the subsequent outcry.

“It can be frustrating,” she says. “People can call us evil, that’s fine,” she adds, pointing out that the company’s medication could potentially eradicate a global public health problem. She says what they’ve done is incredible, and, scientifically, she’s right.

“I think we’ll be on the right side of history.” “Put the word Gilead up and it’s like a Rorschach test,” Pearson says. “You either see lifesaving innovators, tremendous scientists and businessmen, or blood-thirsty corporate greed.” Or, perhaps, all of the above. Grant Cornett for WIRED The Impatience of Patients Prove that a greedy pharmaceutical company has deliberately overpriced its drug and you’re a hero.

Suggest to desperate patients that the drugs they need to stay alive are too expensive (and thus might be taken away) and you’re a villain, a bureaucrat consigning people to death over line items on a budget. This is the dilemma that the scientists at ICER face. Last year the institute held a meeting with a group of pharmaceutical economists and myeloma experts to decide whether Revlimid’s follow-up, Pomalyst, and four other new myeloma drugs were priced fairly. At this point, no head-to-head studies had been carried out on any of the cancer drugs; doctors on the front line were seeing results, they told me, but nobody could say with certainty that Pomalyst—or any other new treatment—was better than its competitors. Along with the economists and doctors in the room were people who don’t normally take much of an interest in incremental cost-effectiveness ratios or comparative p-values: dozens of patients and family members.

Many more were tuned in to the livestream. ICER had, apparently become a known entity after years of quietly gaining influence behind the scenes. In front of the crowd, ICER’s panel determined that four of the newly approved myeloma drugs indeed work, but they’re all dramatically overpriced and don’t represent 'high value.” Pharma is overcharging cancer patients for their livesaving meds, the quants found. When the floor opened to public comments, things got emotional.

The first speaker was Robin Tuohy, who runs patient support groups at the International Myeloma Foundation. Her husband, Michael, was diagnosed with the disease 17 years ago. Without Revlimid, he wouldn’t be alive today. ICER’s reports are a “slippery slope” that could give insurers “leverage to limit or deny access to treatment,” she says. “Your decision will certainly affect lives,” she told Pearson. Other attendees erupted into applause. One after another, patients, caregivers, and Pharma reps stood up and cut into the nonprofit.

ICER likes to think it’s above the fray and apolitical, that it provides “an objective review of evidence and the public forum in which to debate it,” as Pearson says. But Pharma disagrees. For the past year, nonprofits with names like the Alliance for the Adoption of Innovations in Medicine and the Center for Medicine in the Public Interest (which take money from Big Pharma) have been putting out whitepapers suggesting, among other things, that ICER’s methods are flawed (that by comparing the cost of new drugs to the price of an older treatment, say, the institute is intentionally making new treatments appear expensive) or that ICER also gets all its money from insurance companies. (ICER does receive some funding from insurance companies, but the vast majority of its funding comes from a former hedge fund billionaire’s private foundation; he’s interested in market efficiency, his staff says. See WIRED issue 25.02.) One of ICER’s main antagonists is an advocacy group called Patients Rising formed, per their website, “to stand up for patients.” But Patients Rising was co-founded by a communications professional and is funded by Celgene, Amgen, and PhRMA, the pharmaceutical industry’s lobbying arm. Last year Patients Rising started ICER Watch, a blog dedicated to exposing what they consider to be the evils of ICER. Some of the same companies that fund Patients Rising also support the International Myeloma Foundation, a leading patient advocacy group and another fierce critic of ICER.

Related Stories• • • Pearson likes to joke that “we’re the mouse and there are all of these 800-pound elephants stomping around, very afraid of our little reports.” But it’s not very hard for an elephant to crush a mouse. And whatever Pharma’s goal is in attacking ICER’s credibility, it’s not helping the cancer patients who can’t afford their meds. Getting cancer now costs an average patient $5,000 a year out of pocket, and cancer patients are almost three times as likely to declare bankruptcy as healthy Americans.

Cancer patients who go bankrupt have a 79 percent higher mortality rate. Drugs that happen to be expensive can save some people—but drugs that are too expensive can end up killing others.