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Health

Why Investing In Smarter Pill Bottles Could Help Us Save Billions Of Dollars In Health Costs

Concept for a pill bottle that would look a rotting banana when it's past its expiration date. (Credit: Wall Street Journal)

A pill bottle that glows blue when it’s time to take another dose, and red when you’ve accidentally forgotten to take one. Pills embedded with sensors that allow doctors to track who’s swallowing them. A pill bottle that starts to grow spots, like an overripe banana, when the medicine has expired.

Insurers and pharmacies are increasingly investing in these kind of start-up ventures, hoping to develop new technologies that can help Americans stick to their medication regimens. But why is this area of innovation becoming a top priority? It’s largely because the Americans who fail to take their medication as directed contribute to billions of dollars in wasteful health care spending every year. People who skip doses, take pills that have expired, or lapse too long between refills often experience health complications that lead to unnecessary hospital and doctor visits, ultimately costing insurers an estimated $290 billion each year.

Pharmacy-benefit programs like CVS Caremark have typically relied on robo-calls and mailers to remind their patients to take their pills as directed. But the old tricks aren’t working. “After six months’ time, only half of people taking prescription medicines are taking them as directed,” said Troyen Brennan, the chief medical officer of CVS Caremark Corp., explained to the Wall Street Journal.

So they’re trying to step their efforts up a notch. CVS is pilot-testing a new technology that will allow them to better track the patients who have track records of failing to adhere to their medication schedules. And other companies are working on developing apps that will reward patients who take their pills on time with gift certificates and coupons. And they continue to evaluate a range of other innovative ideas to accomplish the same goals, like new high-tech pill bottles.

There have been other recent pushes to build a better pill bottle, too, but those have been focused on addressing a different issue with prescription drugs — the Americans who end up abusing them. In Utah, a group of college students built an electronic pill bottle that will only dispense the specific dosage that the pharmacist has prescribed, preventing their patients from taking too much of the drug or selling the pills to other people. And in New York City, the police force is currently experimenting with implanting GPS chips in pill bottles so they’ll be able to better track stolen drugs and illegal prescription stockpiles.

Health

Everything You Need To Know About The So-Called ‘Sex Superbug’ Threatening The U.S.

At the beginning of this month, mainstream media outlets began to run dire headlines proclaiming the spread of an aggressive “sex superbug,” quoting a doctor who claimed it could be “worse than AIDS.” The breathless proclamations of an impending public health crisis stemmed from a report — published by the Associated Press, among other outlets — that a rare strain of drug-resistant gonorrhea had been detected in Hawaii. That would have marked the first time that the HO41 strain, which doesn’t respond to the last-resort antibiotic currently used to treat the STD, had been discovered within the United States.

“This might be a lot worse than AIDS in the short run because the bacteria is more aggressive and will affect more people quickly,” Alan Christianson, a doctor of naturopathic medicine, was quoted as saying in response to the initial reports about HO41. That was enough to spark speculation about the disastrous implications of an impending “sex superbug.” But much of the recent reporting has been overblown. Here are the facts you need to know about this gonorrhea threat:

The initial reports about the rare strain of gonorrhea got it wrong. State health officials clarified that the strain of gonorrhea discovered in Hawaii wasn’t actually HO41 at all. It was a different version of the sexually transmitted infection, H11S8, which is resistant to a different kind of antibiotic — and which isn’t as serious of a threat, since it can still be treated with the drug currently used as a last resort against gonorrhea. The Associated Press ended up retracting its initial story.

It’s not actually worse than AIDS. After initial reports of the sex superbug began to circulate, public health officials quickly responded to clarify that it’s not helpful or accurate to compare drug-resistant gonorrhea to the global AIDS pandemic. Gonorrhea patients don’t usually die from the condition, while the rate of death from untreated AIDS is a staggering 98 percent. “I disagree with the general comparison,” Dr. Bruce Hirsch, a physician who treats infectious diseases at North Shore University Hospital in Manhasset, N.Y., emphasized.

It was not caused by comprehensive sex education. Earlier this week, a conservative Christian radio host Matt Barber said that liberals in general, and comprehensive sex education specially, caused the new strain of drug-resistant gonorrhea. “By telling children, ‘Don’t do as I say, do as I do’ with comprehensive sex education giving a wink and a nod…hey, it’s a free-for-all,” Barber explained. “Well, we are reaping what we have sewn in this nation.” In fact, comprehensive sex education instruction that includes information about preventing the spread of sexually transmitted infections has been demonstrably successful at equipping American teens with the tools they need to protect their sexual health. The strains of gonorrhea that resist antibiotic treatment were actually caused by a combination of two factors: gonorrhea can mutate fairly quickly, which allows it to evade drug treatment, and we aren’t developing new drugs quickly enough to keep pace.

Drug-resistant gonorrhea is a real public health threat. Despite the fact that the initial story about HO41 was wrong, public health officials are still cautioning Americans that gonorrhea is, in fact, growing resistant to antibiotics — and that’s a real problem. It’s troubling that there’s only one antibiotic left that can effectively treat the infection, especially considering the fact that gonorrhea is the second most common STD in the United States. For months now, the CDC has been recommending “urgent action” to stop the spread of antibiotic-resistant gonorrhea, particularly by studying and developing new antibiotic treatments. The National Coalition of STD Directors believes it could be a matter of just another year or two before untreatable gonorrhea really does spread throughout the country.

The rise of antibiotic-resistant diseases isn’t limited to STDs. Even outside of gonorrhea, antibiotic resistance is becoming a serious global health threat. At the beginning of this year, public health experts in England began to warn of an impending “antibiotic apocalypse,” a not-so-distant future when even common infections aren’t able to be effectively treated with drugs anymore. Drug-resistant strains of tuberculosis and whooping cough are beginning to pose a potential threat, and there’s new evidence that the growing number of superbugs in U.S. meat can spread to Americans. Even though major medical organizations have advocated for making the development of new antibiotics an international priority, that research has lagged behind over the past several decades — partly because that type of innovation isn’t as profitable for Big Pharma companies.

Health

Prescription Drug Spending Drops As Struggling Americans Are Forced To Cut Back On Health Care

(Credit: ClearScript)

For the first time in decades, U.S. prescription drug spending dropped last year — a phenomenon largely stemming from the fact that, faced with spiraling health costs, Americans are being forced to cut back on their care wherever they can.

According to a new report from IMS Institute for Healthcare Informatics, the nation’s total spending on prescription medications dropped from $329.2 billion in 2011 to $325.8 billion last year. Similarly, the average amount that each American spent on their medications in 2012 fell to $898, representing a decline of $33. This is the first time the IMS has recorded a drop in drug spending in the 58 years that the institute has been monitoring the data.

Part of the decline is due to more cheaper, generics drugs entering the market, a positive trend that helps Americans better afford their medication and ultimately lowers health costs. But that’s not the whole story. According to the IMS’ director of research, Michael Kleinrock, many Americans are skipping out on their prescriptions because they’re struggling to afford all of their medical costs, and are therefore being forced to ration their health care:

IMS found affordability of health care remains a big problem for many Americans, with growing out-of-pocket costs forcing people to go without needed doctor visits, medicines and other treatments.

For some, that was because they lost jobs or homes during the worst recession in decades. But higher costs also are hitting many employed people who have health insurance.

Employers have been raising health costs for their workers well above the inflation rate, through higher copayments, premiums and deductibles. Many commercial insurance plans now have annual deductibles — the amount a patient must pay before insurance kicks in — that exceed $1,000, Kleinrock said. [...]

“Even patients with insurance are feeling the pinch and have been reducing their use of health care,” Kleinrock said.

IMS’ findings are consistent with other studies that have found that low-income Americans are forgoing their medication because they can’t afford it. One out of every five Americans has asked their doctor to prescribe a cheaper medication in order to lower their prescription costs — and, compared to wealthier people, poorer patients are more than twice as likely to avoid taking their medication as directed in order to save money.

Of course, as Americans continue to struggle to afford their prescription drugs, Big Pharma is reaping the benefits. The 11 largest drug companies’ profits have been soaring for the past eight years, and they raked in almost $85 billion in 2012.

Unfortunately, profiting at the expense of workers isn’t exclusive to Big Pharma. As Kleinrock notes, even the Americans who currently have insurance are now being forced to cut back on their care, since their employers continue to shift more of their health care costs onto them. Across the country, employees’ contributions to their health insurance plans have skyrocketed at the same time as those workers’ wages have stagnated. That’s especially true for the low-wage workers who are employed by large chain companies in the restaurant industry, whose CEOs have repeatedly complained about the cost of providing adequate health benefits under Obamacare — and keep attempting to find unscrupulous ways to circumvent the health reform law.

Health

Drug Makers Will Help Expand Access To The HPV Vaccine By Dropping Prices In Poor Countries

(Credit: Partners In Health)

Two pharmaceutical giants — Merck and GlaxoSmithKline — have announced that they will drop their prices for HPV vaccines that help protect against cervical cancer to about $4.50 per dose for the world’s poorest countries. The move may help tens of millions of girls in dozens of developing nations gain access to life-saving medications that they would previously have been unable to afford.

Although some critics noted that the companies could drop their prices even further, spokespeople for Merck and Glaxo emphasized that they expected the vaccines’ costs to plummett further in the future. That’s particularly significant given that 275,000 women in poor countries die from cervical cancer every year, mainly due to the high costs of preventative medical services:

The low price will initially apply to a few million doses for demonstration projects in Kenya, Ghana, Laos, Madagascar and elsewhere, but Dr. Seth Berkley, the alliance’s chief executive officer, said he hoped that by 2020, 30 million girls in 40 countries would get the vaccine at that price or less.

The vaccines cost about $130 a dose in the United States, and each girl needs three doses. The lowest price that any other agency or government has negotiated, Dr. Berkley said, is the $13 paid by the Pan American Health Organization, which negotiates a bulk price for Latin American countries. [...]

Dr. Berkley described the new prices as a ceiling, and said he expected them to go down as millions more doses were ordered and as rival vaccine makers from lower-cost countries like India and China entered the field. Other companies, including the Serum Institute of India, the world’s largest vaccine manufacturer, are developing papillomavirus vaccines, but at the moment only the Glaxo and Merck vaccines have approval from the World Health Organization.

Combined with robust public outreach efforts to administer the vaccinations, the lower prices could swell the ranks of immunized women in developing nations beyond the U.S.’s current rates, which the Centers for Disease Control (CDC) has deemed “unacceptably low.”

In fact, the financial and medical benefits of the price cut for poor women could be even greater if the shots are given to younger girls aged nine to 13. A recent study published in the Journal of the American Medical Association (JAMA) found that just two doses of the vaccine were enough to immunize girls in that age range, as opposed to the usual three — meaning that women in developing nations could be protected for a lifetime for just $9 or even less.

Drug accessibility in developing nations has always been a major problem in the public health community, since brand name pharmaceutical companies tend to charge much more for their products than residents of such countries can afford. These drug makers also extend the life of their product patents through gimmicks such as adding “inactive ingredients” to the original medications. The Indian Supreme Court recently ruled against pharmaceutical giant Novartis for precisely this, instead siding with a generic drug manufacturer that distributes a much cheaper — but equally effective — version of the brand name company’s cancer drug. Merck and Glaxo’s proactive decision to cut their HPV vaccine prices means that there are even bigger savings in the future as generic drug makers step up their efforts to compete in the pharmaceutical marketplace.

Health

States Take On Unregulated Pharmaceutical Facilities As House GOP Holds Back Nationwide Reform

(Credit: ABC News)

After last year’s deadly meningitis outbreak was traced to unclean conditions at a New England-area pharmaceutical mixing plant, state and federal officials called for increased oversight of the largely unregulated facilities. But as states await congressional action to give the Food and Drug Administration (FDA) and state agencies more regulatory authority over the so-called “compounders,” many have taken it upon themselves to increase facility inspections in an effort to protect public health.

Since December’s outbreak, five states — including Maryland and Virginia, which experienced fatalities linked to the incident — have already passed new laws strengthening regulation of compounding pharmacies, and another nine have legislation pending. Independent groups have also conducted over 100 inspections in several other states.

But as Politico reports, barring enhanced funding and clearer lines of FDA and state authority endorsed by Congress, there is only so much that states can do on their own:

“NECC just blew this out of the water, and there was a recognition that these guys really weren’t being overseen much at all,” said Joseph Hill, legislative director for the American Society of Health-System Pharmacists. “States realized they need to know who these compounders are, where they are operating and where they are sending product, and to provide some oversight.” [...]

Many states have been devoting the resources needed in the short term to bolster inspections, Catizone said, as they wait to see what Congress will do before passing laws of their own.

But even as states act, the steps they are taking vary. And experts say it would be difficult for them to plug the regulatory hole on their own.

“It’s partly a matter of resources,” Hill said. “You can have the perfect regulation, but if you can’t spend the time and money to give your people specialized training and send them to do inspections, the regulation won’t matter much.”

Those additional resources are particularly significant considering that inspections conducted since the outbreak have revealed that a vast number of compounding facilities violate safety guidelines, including unsanitary conditions such as rusty and moldy mixing plants.

Congressional Democrats have introduced bills that would crack down on compounders by increasing FDA funding, creating a federal database of compounding facilities, and subjecting the drug makers to a minimum level of production standards. But House Republicans have been skeptical about requests for additional resources and tighter regulations, arguing that the FDA’s past failure to prevent outbreaks such as last December’s indicates that such legislative measures would be futile. FDA director Margaret Hamburg has argued that the exact opposite is true, and that barring legislative fixes, the agency will be largely unprepared to address future crises — as will the states that have taken it on themselves to safeguard their residents’ public health.

Health

Over 100 Doctors Slam Big Pharma Over The Sky-High Cost Of Cancer Drugs

A group of over 100 doctors who specialize in chronic myeloid leukemia (CML) published a detailed editorial in the medical journal Blood on Friday that slams pharmaceutical companies for jacking up cancer medication prices to unaffordable degrees. The open letter also calls for immediate reform to help patients access drugs that mean the difference between life and death for millions of Americans.

The doctors argue that, despite the creativity and innovation involved in creating cancer drugs, pharmaceutical companies still charge far more than they are objectively worth, knowing that patients have no other choice than to pay the prices they dictate. The writers then urge an all-in approach to reforming the U.S. medical culture that facilitates price-gouging at the expense of Americans’ physical and financial health:

If drug price reflects value, then it should be proportional to the benefit to patients in objective measures, such as survival prolongation, degree of tumor shrinkage, or improved quality of life. For many tumors, drug prices do not reflect these endpoints, since most anti-cancer drugs provide minor survival benefits, if at all. For example, in pancreatic cancer, where the median survival is 6 months, a new drug that may prolong survival by 2 months, and is priced at $100,000 per year, will cost $67,000 over 8 months survived, or $33,500 per additional month lived, equivalent to $400,000 per additional year lived. [...]

As physicians, we follow the Hippocratic Oath of “Primum non nocere”, first (or above all) do no harm. We believe the unsustainable drug prices in CML and cancer may be causing harm to patients. Advocating for lower drug prices is a necessity to save the lives of patients who cannot afford them. Pricing of cancer and other drugs involves complex societal and political issues which demand immediate attention, and which will need to consider many factors and involve many constituencies…We propose to begin the dialogue by organizing regular meetings, involving all parties concerned, to address the reasons behind high cancer drug prices and offer solutions to reduce them. For CML, and for other cancers, we believe drug prices should reflect objective measures of benefit, but should also not exceed values that harm our patients and societies.

The doctors’ assertions are borne out by the facts. The high costs of treating chronic conditions causes one in four American seniors to go bankrupt. With regard to cancer specifically, the trend is even more pronounced. One study conducted over 14 years in Washington state found a clear relationship between cancer registry data and bankruptcy court records. “Patients diagnosed with cancer may face significant financial stress due to income loss and out-of-pocket costs associated with their treatment,” said health care economist and study author Dr. Scott Ramsey. “On average, bankruptcy rates increased fourfold within five years of diagnosis.”

Pharmaceutical companies often argue that the bloated costs are necessary to cover the substantial research investments and trials-and-error of creating a successful drug. But that logic is undermined by these same companies’ profit-maximizing gimmicks, such as adding inactive ingredients to pills so as to extend expensive brand name drugs’ patents, and paying kickbacks to pharmacies and generic drug manufacturers in exchange for higher market share.

Some developing nations have actually gone beyond the doctors’ suggestions and ruled against brand name cancer drug makers in favor of less costly generic drugs in an effort to help their poor populations access the critical medicines.

Health

How A Pharma Giant May Have Bribed Pharmacies, Swindled Transplant Patients, And Defrauded The U.S.

Novartis Pharmaceuticals Corp. isn’t having the greatest year — and things just got much worse for the drug giant. In a civil suit that builds on a separate, sealed whistleblower case, federal prosecutors charged Novartis on Wednesday morning with paying out kickbacks in an effort to get pharmacies to switch kidney transplant patients’ anti-transplant rejection generic drugs with the brand-name Novartis product Myfortic.

The scope of Novartis’ alleged fraud is staggering. In the civil complaint, prosecutors charge that the company’s U.S.-based wing “used a program of rebates and discounts to boost sales of its anti-rejection drug.” Since Myfortic is far more expensive than its generic counterparts, this market share-gouging cost government health entitlements such as Medicare and Medicaid “tens of millions of dollars in reimbursements to pharmacies for which they were never entitled,” with Myfortic sales at companies that received the bribes totaling over $100 million. Some of those pharmacies allegedly received kickbacks making up a full 20 percent of their total Myfortic sales, while the U.S. government drove an outsized 47 percent of the drug’s total sales by specialty pharmacies.

If the allegations are true, then not only did Novartis brazenly defraud the United States government — the corporation and its co-conspirators also compromised public safety and patient health. As the civil complaint states, “Hundreds, possibly thousands, of transplant patients have undergone switches in their medication as a result of the recommendations from pharmacies that were based on undisclosed financial, rather than independent critical, considerations.”

Medicare and Medicaid fraud by pharmaceutical companies is the main driver of Justice Department settlements under the False Claims Act — the same statute that Novartis is being sued under. In 2012 alone, the Justice Department nabbed $3 billion from doctors and pharmaceutical companies that swindled the public entitlement programs by charging the government more than their services were actually worth. In fact, in 2010, Novartis had to settle a separate case involving kickbacks and misuse of drugs, paying out $420 million in criminal and civil damages. The newest slate of charges against the drug giant prompted Manhattan U.S. Attorney Preet Bharara to call Novartis “a repeat offender.”

Read more

Health

Even After FDA Found Mold At Pharmaceutical Facilities, GOP Is Still Skeptical Of More Regulation

In the wake of last year’s horrific meningitis outbreak stemming from unsanitary practices at a Massachusetts-area compounding pharmacy — facilities where certain drug batches are mixed and prepared — the U.S. Food and Drug Administration (FDA) launched a comprehensive investigation into compounders in 18 states. These facilities are largely out of the purview of federal oversight, which is why FDA director Margaret Hamburg has begged Congress to give her agency more power and clearer guidance to regulate them. But even though the FDA revealed last Thursday that its investigation had found unsafe practices at nearly every facility it audited, House Republicans aren’t sold on Hamburg’s request, and question whether stronger FDA oversight of compounders is warranted.

During a hearing before the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigation, Republican lawmakers expressed skepticism that giving more power to the FDA would accomplish much. GOP committee members pointed out the FDA’s past failure to avert crises such as the meningitis outbreak that killed over 50 Americans. “Ten years of warning signs, alarm bells and flashing red lights were deliberately ignored. Ultimately, the FDA knew [the compounding facility] was breaking the law but chose to do nothing,” said subcommittee chairman Rep. Tom Murphy (R-PA).

As Hamburg pointed out in her testimony, that’s a very skewed version of the facts. Even if the FDA had known about the offending pharmacy, a combination of conflicting statutes and stratified jurisdictional authority would have made it impossible to do much about it. The failure to prevent public health emergencies such as last year’s meningitis outbreak is actually an argument for increasing the FDA’s authority, as the current dynamic is confusing, conflicted, and leaves the agency vulnerable to uncooperative drug makers:

Hamburg said the authority the agency currently possesses is too limited and not enough to properly ensure the safety of some compounding pharmacy products. In particular, she said her biggest concern amongst such pharmacies is with those making what she called “high-risk, sterile” products that are often made in high volumes despite not having an individual prescription and sent out of state. Hamburg estimated about 3,000 compounding pharmacies engage in making sterile products.

She added that there have been several occasions where the FDA has been rebuffed by compounding pharmacies to conduct inspections, saying that the agency does not have such authority, and have sued to prevent access.

In response to questioning from one committee member, Hamburg said she agreed that the International Academy of Compounding Pharmacists, a trade association, has stepped in the way of inspections, adding that “the IACP has for many years questioned our authority.”

House Democrats introduced legislation to crack down on these unregulated pharmacies soon after the meningitis outbreak. That bill — dubbed the SAFE Act — incorporates FDA requests for a federal database of compounding facilities and subjects the drug makers to a minimum level of production standards. Hamburg has warned that, barring additional oversight authority, the FDA is largely powerless to prevent the next outbreak of this kind.

Health

Why The FDA Needs More Power Over Sexual Enhancement, Body Building, And Weight Loss Pills

According to an analysis of Class I drug recalls made over nine years, many of the FDA-approved products that were recalled during that period weren’t actually medications for diseases and other medical conditions. Rather, they were “adulterated dietary supplements,” such as sexual enhancement, body building, and weight loss pills.

Of the 465 recalled drugs examined in the study, 237 were supplements, and the actual number of recalled supplements is likely much higher considering that the study was limited to only one drug class. The findings led researchers to call for “more stringent enforcement” of rules governing the dietary supplement industry, as well as additional regulations for those products that more closely follow the standards used for pharmaceutical drugs. Supplements currently don’t have to undergo the same rigorous safety trials as medication does, leading some public health advocates to worry that unsafe products may be bypassing scrutiny before being released into the market.

The FDA’s comparatively lax regulation of supplements has sparked some recent controversy over energy products like Monster and 5 Hour Energy. Although those drinks have sent Americans to the emergency room by the thousands, the FDA still doesn’t have much oversight over them. Energy products may contain little-known ingredients such as taurine without manufacturers being forced to prove their safety.

This lack of prospective testing leads to a dynamic in which unsafe products often aren’t identified before they’re available for purchase and have already caused consumers medical harm. For example, the FDA finally issued a warning for the common workout supplement ingredient DMAA just this week after concluding that it may lead to an unhealthy rise in blood pressure. That warning — which doesn’t have enforcement power behind it, since it’s just an “advisory” statement and not a formal recall — was issued after the ingredient was legally used in products that are widely available at stores like GNC and the Vitamin Shoppe for over half a decade. During that time, the FDA received at least 86 reports of associated health concerns with products that use DMAA, including at least five deaths.

More stringent safety testing requirements before DMAA’s general use might have revealed potential problems with the chemical at a much earlier stage — and that could very well extend to the rest of the FDA-recalled dietary supplements as well.

Health

Low-Income Americans Are Skipping Out On Their Medication Because It’s Too Expensive

Over the past several years, the cost of both brand-name and generic drugs has skyrocketed, forcing many Americans to struggle to afford the prescription medications they need. In fact, the Centers for Disease Control reports that the United States’ total out-of-pocket drug costs exceeded $45 billion in 2011. And according to the agency’s most recent National Health Interview Survey, one out of every five Americans has asked their doctor to prescribe a cheaper medication in order to lower their prescription costs.

Predictably, the high cost of drugs hits low-income and uninsured Americans the hardest. Nearly 25 percent of uninsured people didn’t take their prescription drugs as recommended in 2011, compared to about 19 percent of privately-insured people and 15 percent of those on Medicaid. And compared to wealthier Americans, poor and near-poor Americans were twice as likely to skip out on their medication in order to save money:

As the CDC points out, this data actually represents an important public health issue, since Americans who don’t take their medication as directed are risking “negative health outcomes.” The agency notes that the adults who don’t take their prescriptions correctly tend to have “poorer health status and increased emergency room use, hospitalizations, and cardiovascular events.” In fact, a recent report estimated that the Americans neglecting to stick to their prescription drug regimen are contributing to billions of dollars in wasteful medical spending, due to the increased medical care that those people end up requiring.

As Americans struggle to afford their prescription drugs, however, Big Pharma is reaping the profits. Last year, the 11 largest global drug companies raked in almost $85 billion.

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