Compounding the Problem?

healthcare crisisHere’s a question to get you thinking this Friday morning.  What has been called the “worst public health crisis” in the US in decades?  Is it:

(a)  HIV

(b)  Obesity

(c)  Healthcare.gov

(d)  Heart Disease

(e)  None of the above

fungal meningitisWhile there’s no doubt options (a) through (d) challenge our healthcare system, the correct answer is in fact (e). What’s more, this public health crisis may have gone unnoticed by many. What we’re referring to is the fungal meningitis outbreak that was traced to the New England Compounding Center. So far, there have 751 reported cases, including 64 deaths.

fungal meningitis case-counts-960px-2013-10-23Indeed, most Americans had never heard of compounding pharmacies until the now-shuttered New England Compounding Center was blamed for making tainted steroid injections that killed and sickened people in 20 states.

Since then, the FDA has issued more than 60 reports of compounding pharmacies that had one or more quality or sterility issues. Five compounding pharmacy testing labs received similar reports.

Now, after months of negotiating, the US Senate has finally passed legislation that was drafted in the wake of the scandal.  The Drug Quality and Security Bill will give the FDA greater oversight of compounding pharmacies and also creates a national system for tracking prescription medicines from factory to pharmacy. The bill, which was already passed by the US House, is designed to bolster the pharmaceutical supply chain, and now goes to President Obama for his signature

The bill will create a new class of compounding pharmacies, as suggested by the FDA. The agency believes that traditional compounders – those who mix or alter ingredients for individual patients on an as-needed basis, should be distinguished from ‘non-traditional’ compounders – those that sell high volumes and ship out of state because these activities may pose a higher risk.

We know more from a barcode on a gallon of milk than we do from a barcode on a bottle of prescription drugs, which could mean the difference between life and death,” says US Senator Michael Bennet. “Whether it’s a stronger drug supply chain or better oversight for compounded drugs, this commonsense bill will help restore confidence in our prescription drugs and protect our families from potential health risks.”

compoundingThe bill also creates a voluntary category for so-called office compounding of sterile medications. These operations would voluntarily register with the FDA and submit to GMP, or good manufacturing practices, compliance and pay fees in exchange for the right to ship product without a prescription. But there is no criteria concerning interstate shipping or the percentage of production involved.

The legislation “leaves regulation of this vital and long-accepted practice by independent community pharmacies to state boards of pharmacy, where it should be,” says the National Community Pharmacists Association.

But not everyone agrees.

Rosa DeLauro, a Democratic Congresswoman from Connecticut, says the “voluntary approach will continue to expose patients to potentially unsafe, mass-produced compounded drugs that are not approved or evaluated by the FDA.”

NECC steroidsSimilarly, the International Academy of Compounding Pharmacists released a statement saying that “a voluntary category of outsourcing facilities is not the answer” and warned that another potentially deadly New England Compounding Center type of scandal could still occur.

Some health policy experts have even said they fear the new bill will make drugs, less, rather than more, safe.

Critics say that by giving compounding pharmacies the option whether or not to register with the Food and Drug Administration and adhere to stricter guidelines for testing, quality and sterility, does not go far enough.

It makes what is now illegal legal,” said Dr. Michael Carome, who directs the health research group at Public Citizen, a think tank.

Carome said he opposes the bill because it allows large scale compounding without individual prescriptions and with no requirement to follow the strictest quality and sterility guidelines that drug manufacturers must adhere to.

It makes no sense to have two different tiers of drug manufacturers – one that has to meet all the manufacturing guidelines and one that only has to meet some of them. We believe in a level playing field.”

What do you think of this legislation?  Has it gone far enough?  We’d love to hear from you.

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FDA ups the Ante on Pharma Ads

bad ad cme courseAs the feds continue to crack down on pharma marketing infractions the FDA has upped its own stake in making sure advertisers play by the rules. The agency has just launched an e-learning course aimed at healthcare providers to teach them how to spot and report misleading or untruthful drug ads, or promotional activities.

The multi-module, multi-media  course, launched in conjunction with MedScape, uses case studies to help HCP’s “become more discerning readers of drug promotional information,” according to Thomas Abrams, director of the FDA’s Office of Prescription Drug Promotion.

bad ad course screen shotThe course is part of Bad Ad, a program the agency designed in 2010 to educate doctors about their role in ensuring advertising stays honest. And to incentivize doctors to take the course they are offering Continuing Medical Education (CME) credit for physicians and Continuing Education (CE) credit for other HCPs.

The FDA estimates that there are more than 80,000 unique new pieces of promotional literature produced each year, including journal ads, sales aids and e-detailing pieces.  In addition, there are approximately 80,000 pharmaceutical sales reps working in the field. Assuming each one makes 8-10 calls per day and presents 1-3 products during every call, that adds up to between 166 and 624 million opportunities to breach promotional guidelines.

Over the past decade, drug-makers have agreed to pay close to $14 billion in penance for off-label and safety-related claims. Click on the links below for details of the biggest 11 settlements in recent years:

Back when the FDA was rolling out the Bad Ad program, the agency drew fire from marketing execs for encouraging physicians and other providers to report false advertising  – and for allowing them to do so anonymously. They accused the agency of deputizing doctors rather than hiring the staff necessary to review advertising internally.

Even so, many states have taken their own steps to combat misleading materials through “academic detailing,” where physicians, pharmacists, nurses and other trained medical reps spread info about prescription drugs. The goal is to improve quality of care and reduce healthcare spending. Advocates of academic detailing say that educating prescribers about all treatment options – not just the new, expensive ones – could help them make informed decisions that could, in turn, bring down drug costs.

Bad Ad brochure Pharma sales and marketing folks take note.  Between these federal and state initiatives, the potential for falling foul of the guidance just increased.

And yes, in case you’re wondering I did take, and pass, the course as part of my research for this blog post.

Contact us today, to find out how SRxA can help you with compliant pharma promotion.

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Should new drugs wear a ‘Proceed with Caution’ label?

SRxA’s Word on Health was alarmed to read a new study showing that almost a quarter of prescription drugs approved in Canada over 16 years were later slapped with serious safety warnings or yanked from the market for safety reasons. As Canada’s drug safety agency operates much like the U.S. Food and Drug Administration (FDA), the study may reflect the state of drug safety in the United States as well.

When assessing a new drug, regulators at Health Canada and the FDA are entrusted with making critical and difficult scientific judgments that can affect the health of hundreds of thousands of patients in a matter of months after product launch.

And the cost of error may be high given that the number of people exposed to unsafe drugs may be in the millions.

University of Toronto health policy researcher Dr. Joel Lexchin looked at the 434 drug approvals that moved through Health Canada’s drug-safety arm from the start of 1995 to the end of 2010.

About a quarter of the drugs approved in that period received a fast-track deliberation known as a “priority review” which lasts 180 days instead of the typical 300 days.

Lexchin found that drugs approved this way were 50% more likely to end up with safety warnings, compared with drugs approved according to the customary deliberation period.

And while you might assume that the most-risky drugs would be those those fast-tracked for approval for life-threatening diseases such as cancer and HIV, Lexchin discovered they were no more likely to have safety concerns than drugs fast-tracked for less serious illnesses.

That was a surprise, because regulators could be expected to accept some heightened risks when approving new medications to treat serious illness.

In an accompanying editorial, Thomas J. Moore of the Institute for Safe Medication Practices suggests that new drugs should carry special labeling for their first three years on the market, so that doctors are reminded to prescribe with caution.

Getting faster access to newer, less-thoroughly tested drugs is at best a mixed blessing,” said Moore. “For the first three years after approval, new drugs should carry a special warning akin to the black triangle used in Britain. It should be prominent and mean to every physician, ‘New Drug: Caution Indicated.’

That caution may be worth remembering by both physicians and patients when considering switching to new drugs.

i-Nhaler i-Mprovement?

Asthma is one of the world’s most common chronic diseases, affecting some 300 million people and almost 5 percent of the world’s population. It’s also the 5th most costly condition in the US  – an estimated at $56 billion annually. But as we’ve reported here previously, a significant number of people with asthma either don’t use their asthma medications or use them incorrectly.

Improving asthma control is known to reduce the cost of treating asthma by eliminating unnecessary hospitalizations, ED visits, and office visits. The additional cost of an uncontrolled asthma patient compared to a controlled asthma patient is estimated at $3,000-$4,000  per patient annually.

So, we were interested to learn last week that the FDA approved a sensorized asthma inhaler that can track usage and transmit the data to a smartphone and the web. The manufacturer – Asthmapolis will begin to market the asthma sensor and both English and Spanish language versions of the companion software in the US very soon.

Our mission is to make it easier for patients and their physicians to do a better job of managing asthma with less effort than traditionally required.” said David Van Sickle, co-founder and CEO of Asthmapolis.

The small and lightweight device attaches to the end of most inhalers, and the app tracks the time and location of each medication discharge and reminds patients to use it if they forget.

In clinical studies of the Asthmapolis system, uncontrolled asthma declined by 50%, and more than 70% of patients improved their level of control.  In addition it can identify trends in a patients asthma triggers and symptoms over time and provide patients with personalized education on how to improve their asthma.

Not only will the device talk directly to the patients, physicians and other health care providers will be able to identify, in near-real-time, patients with uncontrolled disease and attend to them before they suffer a severe exacerbation.

Despite all we know about asthma and how to treat it, the majority of patients still do not have the disease under control, and traditional approaches to self-management have been time-consuming and complicated,” said Inger Couture, chief regulatory officer of Asthmapolis. “The Asthmapolis technology makes it much easier to track symptoms and use of metered dose inhalers, allowing patients, their families and their doctors to gain a valuable new perspective on the disease.”

And that can only be a good thing.

It’s here! HIV Prevention in a Pill

An estimated 1.2 million Americans are currently living with HIV. Despite the availability of condoms and HIV education, the incidence rate has remained steady over the past two decades with approximately 50,000 new infections occurring each year. 23% of these new cases occur among women and 61% occur among men who have sex with men.

In the 80′s and early 90′s, HIV was viewed as a life-threatening disease. In some parts of the world, it still is. And while medical advances, along with the availability of 30 or so approved HIV drugs, mean its now a chronic disease, rather than a killer disease – what we’ve all been waiting for is a drug to prevent it.

Now, this week, after decades of anticipation, the FDA  approved Truvada – an HIV combination pill for pre-exposure prophylaxis.  Truvada is the first drug that has been approved to combat HIV among uninfected individuals who are believed to be at high risk of acquiring the virus. Analysts estimate that the drug will cost $450 a year in the U.S.

In a study sponsored by the National Institutes of Health, Truvada was shown to significantly reduce the risk of HIV infection in 42% of HIV-negative gay and bisexual men and transgender women. In another, the risk was lowered in 75% of heterosexual couples in which one partner was HIV positive and the other was not.

The data clearly demonstrate that Truvada, as pre-exposure prophylaxis, is effective at reducing the risk of HIV infection acquired through sexual exposure,” said Connie Celum, a professor of global health and medicine at the University of Washington and lead investigator of the second study.

As part of the approval, the FDA has stipulated that patients must test negative for HIV and that education guides must be distributed to healthcare providers and patients. And the manufacturer – Gilead must conduct a post-approval trial looking at levels of drug adherence, adverse events, resistance and pregnancy outcomes for women who become pregnant while taking Truvada.

The approval of Truvada comes after a long-running debate among AIDS activists. To some, FDA approval offers much-needed assistance in containing the disease. To others, it raises the possibility of creating resistant strains of HIV due to widespread use, just as we saw in the 1960’s with antibiotics, which would then undermine the effectiveness of Truvada.

While the approval may be a cause of celebration for many, some have blasted the decision. “The FDA’s approval of Gilead’s Truvada as a form of HIV prevention today without any requirement for HIV testing is completely reckless and a move that will ultimately set back years of HIV prevention efforts,” says AIDS Health Foundation president Michael Weinstein. “The FDA’s move today is negligence bordering on the equivalence of malpractice, which will sadly result in new infections, drug resistance and serious side effects among many, many people.”

So is this a watershed moment in the battle against HIV or not?  Let us know what you think.

FDA Ad Study: Clarifying the Confusion

As a public health agency, the FDA encourages the communication of accurate health messages about medical conditions and treatment.  One way the pharma industry does this is through non-branded disease awareness communications. These are aimed at either the general public or health care practitioners and discuss a particular disease or health condition, without making mention of any specific drug.  Usually, they encourage consumers to seek, and health care practitioners to provide, appropriate treatment for the particular disease state.

This is helpful for under-diagnosed and under-treated diseases such as depression, hyperlipidemia, hypertension, osteoporosis, and diabetes. Some research has shown that consumers prefer disease awareness advertising. It’s considered more informative and less persuasive than full product advertising.

The pharma industry likes it too.  Disease awareness communications are not subject to the regulations and restrictions mandated by the FDA for prescription drug advertising.

But now, the FDA is concerned that disease awareness ads might confuse consumers. According to a Federal Register notice issued on June 20, the agency wants to know whether the public can distinguish between product claims and disease information, and how different types of information impact comprehension.

So worried in fact,  the Agency has planned a study entitled, “Experimental Study: Disease Information in Branded Promotional Material” to look into those questions.

The study will examine print ads for three conditions – COPD, lymphoma and anemia.

4,650 American adults will be divided into three groups and asked to review the ads electronically.

  • One group will see information about the disease that avoids discussion of disease outcomes the drug has not been shown to address i.e.  “Diabetes is a disease in which blood sugar can vary uncontrollably, leading to uncomfortable episodes of high or low blood sugar.”
  • Other participants will see disease information that mentions consequences of the disease that go beyond the indication of the advertised product, such as, “Untreated diabetes can lead to blindness, amputation, and, in some cases, death.”
  • A third group will see drug product information only.

Disease information will be presented in different ways. For example, on alternating paragraphs, on separate pages or in different fonts and colors from product claims.

Specifically the study will address whether or not consumers are able to distinguish between claims made for a medication and general disease information when they see an advertisement for a drug.  For example, if an ad for a drug that lowers blood glucose, mentions diabetic retinopathy do consumers  think the drug will prevent the affliction, even if no direct claim is made?

The Agency says: “If consumers are able to distinguish between disease information and product claims in an ad, then they will not be misled by the inclusion of disease information in a branded ad. If consumers are unable to distinguish these two, however, then consumers may be misled into believing that a particular drug is effective against long-term consequences.”

SRxA’s Word on Health looks forward to seeing the results. Given that warning letters have been issued in the past over ads that contain mixed messages, this is an opportunity for the FDA to revisit its stance toward such advertising, reduce consumer confusion and, most importantly, learn how best to disseminate useful health information.

Insulin Patch Offers Hope of Needle Free Diabetes Management

Transdermal Specialties Inc. (TSI) is hoping to change the face, not to mention the abdomen, upper arm and thighs, of patients with diabetes.  The company’s new “Set IT And Forget IT” insulin delivery system will be unveiled at the American Diabetes Association’s 72nd Annual Scientific Meeting, June 9 -11, 2012 in Philadelphia.

Called the U-STRIP™, this breakthrough product is a programmable transdermal insulin patch which offers totally non-invasive insulin delivery for both Type-1 and Type-2 diabetic patients.

Using a patented alternating ultrasonic waveform process to enlarge the diameter of the skin pores, the U-Strip enables large molecule drugs, such as insulin, to permeate through the skin into the dermis and then into the blood stream. All without needles!

According to TSI, the key advantages of the U-Strip include:

  • Delivers insulin for both basal and bolus needs
  • Patches available in four different doses: 25, 50, 100 & 150 Units
  • Electronic delivery system tracks dosing history and glucose readings
  • Downloads data to physician for progress monitoring

12 clinical trials in over 125 diabetics have already been successfully completed. The company hopes to complete the last two clinical trials needed for FDA approval in the next 18 months.

The HPT- 6 trial will investigate whether the patch can reach the same glucose levels as a pump with less insulin, and will also compare the speed of delivery vs. injection to determine if the patch can be more effective in morning glucose reduction for those patients waking with high blood sugar levels.

The HPT-7 trial (slated for 2013) will focus on a real-world study of 500 Type-2 diabetics, who will conduct an at-home study to track their A1C levels. The A1C test measures average blood glucose control for the past 2 to 3 months.

The U-Strip represents a major advance in diabetes care” says Bruce K. Redding, Founder, President and CEO of TSI. “The insulin patch component offers a safe and painless alternative to injections with the promise of reduced side effects and improved insulin uptake efficiencies for the patient. The ultrasound actually reduces the quantity of insulin needed for effective glucose control and speeds the delivery over a pump or even direct injection. Improved patient monitoring and reporting of the Control Device enables better tracking of treatment programs and the new “Set-it and Forget-it”  function means more regular glucose control during both evening and daytime hours.

All of which sound like good news for the 27 million diabetics in the US, who eagerly await an alternative to injections. Over the years, various attempts, some more successful than others, have been made to capture this $3 billion market.

SRxA’s Word on Health will be keeping a watch on all diabetes developments and we’ll bring you further news as it happens.

Prescriptions, Physicians, Patients and Payers: Let the battle commence!

Last week the FDA announced that it wants to remove obstacles to America’s most commonly used drug treatments.  If the Agency gets its way, some drugs used to control chronic conditions, such as high cholesterol, diabetes and asthma may soon be available without prescription.  But in doing so, they have reopened a  big can of worms. One that brings into question the very nature of health reforms, preventative medicine and improved access to healthcare.

Here’s the proposal: The FDA would create a new class of “safe use” drugs. While consumers would not need a prescription, they would still need to get clearance from a pharmacist or from specially designed websites to purchase them.

Battle lines are being drawn! With physicians on one side, and patients, pharmacists, pharma and payers on the other.

Doctors are most definitely not thrilled by the idea. Removing the prescription requirement for an inhaler refill, for example, doctors fear they would be taken out of the loop on everyday care decisions.

Insurers, on the other hand are embracing the move. They recognize that they could save big bucks if physician visits weren’t required for run-of-the-mill complaints and ongoing medication monitoring. They might even save on the costs of the drugs themselves because, depending upon how they’re classified, most health plans don’t pay for over-the-counter treatments.

Pharmacists see it as validation of their expertise and pivotal role in primary healthcare and the pharmaceutical industry, who has repeatedly asked for permission to sell such drugs over-the-counter, must surely be cautiously optimistic.

Even normally conservative regulators are supporting the move. “Greater over-the-counter and behind-the-counter access will lower costs and make healthcare more accessible to consumers,” former FDA commissioner Scott Gottlieb said via Twitter. “It’s a good idea, long overdue.”

Even so, the FDA will have a fight on its hands as it moves to turn its proposal into reality. The American Medical Association lambasted the idea in USA Today, saying that patients need guidance from doctors. The doctors’ association also points out that giving patients more control could complicate coordinating care, such as, tracking all the drugs a patient uses to prevent interactions.

But, as The Washington Post points out, FDA sees the doctor’s visit as a hindrance to care; some patients don’t seek treatment if they have to see a physician first. “Obviously, it’s much easier for you to go to your drug store and pick up an item than it is to make an appointment, take a prescription, drop it off and get it filled,” says Nancy Chockley, president of the National Institute for Health Care Management.

About 20% of prescriptions written in the United States currently go unfilled. Removing obstacles that keep Americans from managing their own health care is, according to one patient, namely me, a good thing.

The FDA contends, and I agree, that some consumers may not even go as far as getting a prescription because of the “cost and time required to visit a health-care practitioner.  Earlier this month, I stood in line at my local pharmacy for thirty minutes to pick up a refill prescription for blood pressure meds. On reaching the end of the line I was told that there was no prescription. The pharmacist called my doctor and the lack of prescription was confirmed. I called my doctor and was told I would need to make an appointment to have the prescription renewed. I pointed out that I had done that one month earlier and that nothing had changed regarding my health. I was then informed that it was a new policy to issue prescriptions on a month-by-month basis rather than provide automatic refills. Even when I pointed out that I have a chronic condition that I’m doing my best to manage and part of that management is the medicine I have been taking for years, they wouldn’t sway. No doctors visit, no prescription.  And the kicker, I couldn’t get an appointment to see my doctor for a week…meaning, I had to go 7 days without blood pressure meds, all so my doctor could better manage my care!

Practicing medication adherence is very hard when your doctor won’t give you medication…and leaves me wondering if this policy change had more to do with revenue generation than improving chronic disease management.

My personal experience aside, at the heart of this discussion is a fundamental disagreement over what role doctors play in managing patient care. The FDA proposal views a trip to the physician as a hindrance to care, whereas doctors see that visit as crucial, especially as chronic conditions become increasingly prevalent.

The FDA proposal is still in formative stages, meaning there’s still a lot of space for this debate to evolve. Where the discussion heads on this particular issue could end up guiding health policy on what role doctors play in managing patient care – and, at what point, the patient takes charge.

I, for one, can’t wait to see how it plays out, assuming of course that I’m not dead from uncontrolled hypertension!

You Can Teach an Old Drug New Tricks

Drug discovery is a laborious process.

From initial discovery of a promising target to the final medication becoming available, is an expensive, and lengthy process. At present, the costs of bringing a single new drug to market is around $1.2 billion, an amount that doubles every five years.

Aside from the cost, it takes, on average, 12 years for an experimental drug to progress from bench through FDA approval to market.

Annually, North American and European pharmaceutical industries invest more than $40 billion to identify and develop new drugs. Even so, for every 5,000 compounds that enter pre-clinical testing, only five, on average, are tested in human trials, and only one of these five receives approval for therapeutic use.

So, it’s hardly surprising that many pharmaceutical companies are choosing to take a closer look at old drugs. Last week, SRxA’s Word on Health brought you news of a host of potential new uses for aspirin.

And aspirin is not alone.  Old drugs often get a surprising second shot at life. In the past few weeks, the news has buzzed about the skin cancer drug – bexarotene – that may cure Alzheimer’s; a common antimalarial drug – hydroxychloroquine – that may help to destroy cancerand, a leukemia drug that inhibits the Ebola virus.

Then, of course, there’s the personal favorite of many women – Latisse.  Originally developed as a glaucoma treatment , it was found to have the desirable side effect of making eyelashes fuller and longer and is now FDA approved for this purpose.

Testing drugs already approved for one use to see if they can treat other conditions, can reduce time and money. Since these known drugs have already undergone toxicology and safety testing, the clinical development program can be streamlined.

Sometimes it’s pure serendipity.

Take Viagra for example. Although these days it’s the stuff of pharmaceutical industry legend , in the early 1990s, it was just a chest pain drug that wasn’t performing very well in clinical trials. So how did the little blue pill go from heart to crotch?  Pfizer was ready to call it quits when they decided to look into one unexpected but common side effect: long-lasting erections. Then came the drug patent and the rest is history.

The discovery that lithium could be used to treat manic episodes in bipolar patients was equally fortuitous. In 1949, Australian psychiatrist John Cade was injecting guinea pigs with urine extracts from schizophrenia patients to try and isolate a compound that caused mental illness. By accident he happened to use a compound with lithium – which at the time was used as a treatment for gout, as the control. Although he didn’t find the compound that caused mental illness, he did find one that treated it!

Back in 2010 we reported on the repurposing of thalidomide. Although the drug caused serious birth defects when it was launched in the 1960’s as a morning sickness pill it has since been found to be useful in reducing severe and frequent bleeding in patients with  hemorrhagic telangiectasia (HHT); in the treatment of patients with newly diagnosed multiple myeloma when taken  in combination with dexamethasone; and for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum

The National Institutes of Health (NIH) recently established The Learning Collaborative (TLC) to study how to more easily repurpose known drugs to treat rare forms of blood cancers.

TLC is a dedicated collaboration between the NIH Chemical Genomics Center (NCGC) and its Therapeutics for Rare and Neglected Diseases (TRND) program, The Leukemia & Lymphoma Society (LLS), and Kansas University Cancer Center (KUCC) to discover and develop new drug therapies for rare blood cancers. TLC is creating a pipeline of new therapies to treat leukemia from both the discovery of new treatments as well as identifying new uses for approved and abandoned drugs.  For example, Auranofin, a drug originally used for rheumatoid arthritis, is now in clinical trials for treating chronic lymphocytic leukemia.

Word on Health will continue to follow the drug recycling trend and bring you news as it breaks. In the meantime if you have noticed any beneficial side effects from the medicines you’re taking, we’d love to know.

There’s a Shot for That

On May 14, 1796 Edward Jenner injected fluid from the cowpox blisters on the hands of dairymaid Sarah Nelmes, into James Phipps, an 8-year-old boy.  Jenner hoped the fluid from the cowpox lesion would somehow inoculate the boy against the smallpox scourge which at the time was killing over 400,000 Europeans a year. His hunch proved correct.

Today vaccines save 3 million lives per year worldwide. By training the human immune system to recognize and ward off dangerous pathogens, vaccines can protect against disease for decades, or even for a lifetime. Preventive vaccines work by introducing harmless microbial chemical markers, known as antigens, which resemble the markers on living microbes. The antigens train the immune system to recognize and destroy those microbes should they ever appear in the body. By injecting cowpox antigens into Phipps bloodstream, Jenner primed his immune system to attack the similar smallpox virus.

Now, medical scientists are taking Jenner’s ideas in a whole new direction. By exploiting a growing understanding of the immune system they are developing therapeutic vaccines targeting established diseases rather than trying to prevent them.

Last spring, the FDA approved Provenge, a personalized immunotherapy that activates a patient’s own immune cells to target and attack advanced prostate cancer. To make the Provenge prostate cancer vaccine, biochemists at Seattle’s Dendreon Corporation extract a sample of a patient’s own immune cells and bathe them in a chemical soup of prostate cancer antigens that are chemically linked to a cytokine that screams, “Attack this!”.  The activated immune cells are then injected back into the patient’s body to spread the call to arms.

While Provenge was the first of the new generation of therapeutic vaccines, it’s certainly not the last. BCC Research has identified 113 therapeutic vaccines in development, many of which are already in human trials. They even go so far as to estimate that the market for therapeutic vaccines will have an annual growth rate of 115% and reach an estimated $2.9 billion in 2014.

Other cancer vaccines are among the front runners. With a near-endless supply of patients willing to undergo novel treatments, cancer researchers have been among the most aggressive in experimenting with therapeutic vaccination. The Cancer Vaccine Collaborative is working on treatments that target multiple cancer antigens, which should trigger a more aggressive immune response and increase the odds of defeating tumors. All of which is good news for the 1.5 million Americans diagnosed with cancer each year.

While cancers cause a proliferation of diseased cells, some autoimmune diseases, cause the cells of the immune system to turn against healthy tissues. In diabetes, for example, the immune system attacks insulin-making pancreatic beta cells.

In multiple sclerosis, it’s the myelin sheaths that are designed to protect the nerves that come under attack.

Autoimmune vaccines hold the promise of shutting down these attacks. One promising approach boosts T-regulatory cells, a subgroup of the white blood cells. At the University of Calgary’s Diabetes Research Centre in Alberta, immunologist Pere Santamaria has attached a cocktail of antigens from pancreatic beta cells to synthetic iron oxide nanoparticles. This stimulates the development of T-regulatory cells into killer T cells that destroy the immune cells which cause the serial killer like autoimmune attack.

Santamaria’s team recently tested his vaccine in diabetes-prone mice. It restored normal blood sugar and insulin levels in animals that already had diabetes and prevented or slowed its onset in young mice that had not yet developed the disease. The team is now readying the vaccine for human trials and is designing related vaccines to treat other autoimmune diseases, including multiple sclerosis, rheumatoid arthritis, and inflammatory bowel disease.

If effective, such therapeutic vaccines could help the three million Americans with type 1 diabetes and the 400,000 people diagnosed with multiple sclerosis. Vaccines against dust mites and asthma are also in the works.

Some of the new therapeutic vaccines are actually designed to attack the body, albeit in a selective way. A new experimental heart-disease vaccine takes aim at unwanted biochemicals within the body, specifically low-density lipoprotein (LDL), better known as bad cholesterol. When large quantities of LDL cholesterol circulate through the bloodstream, it can be deposited on artery walls, leading to a buildup of plaque and triggering inflammation. Anti-cholesterol vaccines encourage the immune system to attack LDL and remove plaques. Scientists have also discovered that the vaccine lowers blood pressure and protects against the rupture of aneurysms, at least in mice.

Clinical trials in humans are expected to start later this year and if successful could help to prevent the 800,000+ deaths per year from cardiovascular disease.

Even more people could be helped by an anti-obesity vaccine. Nearly 75 million adults are classified as obese in the United States. Researchers are working on a vaccine that targets ghrelin – a gastrointestinal hormone that appears to stimulate appetite.

Others, are looking at vaccines to prevent addiction to cocaine, methamphetamines, opiates and nicotine.

It is too soon to know how and when these vaccines will come to market or how effective they will be, but it’s clear that therapeutic vaccines are coming and will be used against a host of the most prevailing public health issues of the 21st century.