2013 Drug News Round-Up: Top 20 Stories

Breast Cancer Prevention: Success and Controversy

An updated 2013 guideline issued by the the American Society of Clinical Oncology more strongly suggested that clinicians discuss the option of preventive medication use with drugs like tamoxifen (Nolvadex) or exemestane (Aromasin) in women at high risk of breast cancer. In October, Perjeta (pertuzumab) was the first drug approved as a first-step breast cancer therapy instead of surgery. Actress Angelina Jolie revealed in May that she carried the BRCA breast cancer gene mutation and had undergone a double mastectomy to lower risk. Jolie's controversial, yet personal, decision sparked interest from many American women who said they would consider seeking medical advice on the issue.

First Breakthrough Therapies Approved in 2013

The FDA may designate a drug as a 'Breakthrough Therapy' in order to expedite the drug approval process for serious or life-threatening diseases. For the first time, three 'Breakthrough Therapies' were approved at year's end - in November Gazyva (obinutuzumab), to treat patients with chronic lymphocytic leukemia, and Imbruvica (ibrutinib), for patients with Mantle Cell Lymphoma, a rapidly spreading blood cancer. In December, Gilead’s Sovaldi (sofosbuvir) was approved for chronic hepatitis C virus (HCV) infection. Sovaldi, an oral treatment with fewer side effects, will allow some HCV patients to be treated with interferon-free regimens.

Acting F.A.S.T for Stroke Awareness

Stroke awareness education campaigns were clear-cut in 2013. The acronym F.A.S.T. -- Face drooping, Arm weakness, Speech difficulty, Time to call 911 -- made it on highway billboards. In February, new guidelines from the American Stroke Association emphasized that receiving clot-busting (thrombolytic) drugs such as tissue plasminogen activators (tPA) within one hour of arriving in the emergency room is crucial to minimizing brain damage.

In June, a study in over 58,000 subjects published in JAMA confirmed that those treated within 90 minutes of stroke symptom onset have markedly better outcomes.

Deception: Lance Armstrong

In October 2012 allegations were made claiming the USPS Cycling Team drug doping scheme was orchestrated by seven-time Tour de France winner Lance Armstrong to '...ultimately gain an unfair competitive advantage through superior doping practices.'

Last January, Armstrong confessed to use of doping practices in cycling on the Oprah Winfrey Network (OWN) -- including use of erythropoetin (EPO), anabolic steroids, blood doping, and corticosteroids. Armstrong’s name has been removed from his seven back-to-back Tour de France titles spanning from 1999 to 2005. The winner’s spot for those years will remain empty.

Drug Shortages Decline in 2013

In 2013, the FDA continued to take action to address drug shortages. Many shortages involved drugs for cancer patients - including children. In fact, a recent survey noted that 80% of cancer doctors have faced a drug shortage at sometime. FDA issued a proposed rule requiring manufacturers to give notice if they intend to discontinue crucial drugs or run into supply issues. In February the FDA took action and approved the first generic version of chemotherapy drug Doxil (doxorubicin hydrochloride liposome injection) - the brand was found on the FDA drug shortage list. This list allows the FDA to initiate expedited review of generic applications to help alleviate brand name drug shortages.

New Flu Vaccine Options: Sorry, You're Out of Excuses

In recent years, the FDA has approved several new formulations of the influenza vaccine - so many, in fact, that you probably do not have any more valid excuses to skip your vaccine. In the 2013-2014 flu season, there was a big change to both injectable (Fluzone, Fluarix, FluLaval) and nasal (Flumist) vaccines - a quadrivalent formulation became available that protects against an extra strain of B influenza. Allergic to eggs? Sorry, can't use that excuse anymore, either - FDA approved Flublok, a trivalent, inactivated vaccine made without egg proteins - in early 2013. In the 2012-2013 flu season, vaccinations prevented at least 6.6 million cases of flu-associated illness.

Over 1,600 Illegal Online Pharmacies Shut Down

As reported in July, the FDA, in concert with the Colorado U.S. Attorney’s Office, seized and shut down more than 1,600 illegal pharmacy websites in an operation dubbed 'Pangea'. The crackdown was part of an effort to protect consumers from illegal, potentially dangerous, unapproved prescription drugs sold online. Medicines sold illegally included Avandaryl, Celebrex, 'Levitra Super Force', diabetes treatments and clozapine. FDA-approved versions of these medications exist in the U.S. but the online drugs were fraudulent. The FDA's Cybercrime Investigations Unit banner is now displayed on seized websites to help consumers identify them as illegal.

Vitamin D: To Be or Not to Be

The health benefits (or lack thereof) of vitamin D was a hot topic in 2013. Low vitamin D levels have been associated with osteoporosis, heart disease, and certain cancers. In 2013, a study in JAMA refuted research that vitamin D could reduce pain or cartilage loss in those with knee osteoarthritis. British researchers reported that obesity could lead to a vitamin D deficiency. One study found labeled doses of vitamin D supplements were inaccurate, ranging from 9 to 146 percent of what was on the label. And a large study from New Zealand strengthened evidence that taking vitamin D alone does not improved bone mineral density. Finding you enjoy vitamin D news? More is sure to come in 2014.

Reeling In Opioid Abuse

Opioid abuse is at epidemic levels. Over 22 million Americans have misused prescription painkillers since 2002. The narcotic painkiller hydrocodone, commonly found in medications like Vicodin and Lortab (hydrocodone and acetaminophen) is a major culprit in the U.S. narcotic abuse epidemic. A panel of FDA advisors recommended in January that hydrocodone combination treatments be reclassified from DEA Schedule III to the more restrictive Schedule II. In addition, new formulations of painkillers like Oxycontin that are more difficult to snort or inject were approved to help curtail abuse. In September, the FDA strengthened label warnings for long-acting opioids, as well.

Is HealthCare.gov Fixed?

The initially mismanaged and poorly designed Healthcare.gov website, part of Obamacare, still continues to top healthcare headlines at year's end. The Obama administration was hopeful its health-care reform package could lend medical security to millions, but technical fouls on the federal government's HealthCare.gov portal left consumers on the sidelines. In fact, just six people were able to sign up for benefits on the day of the website's Oct. 1 launch. However, by December 11, 2013, HHS announced that nearly 365,000 consumers - including many young adults under 26 years - had successfully selected a health plan through the online exchanges.

Signed Into Law: FDA Regulates Compounding Pharmacies

In 2013, the FDA began regulation of compounding pharmacies -- pharmacies that create new drug combinations for individual patients. The law was prompted by the 2012 deaths of 64 people who received pharmacy-compounded but fungus-contaminated injectable methylprednisolone for joint pain. Compounding pharmacies, when registered with the FDA, are classified as outsourcing pharmacies, enabling them to sell bulk drugs to health-care facilities. However, since pharmacy registration is voluntary, unregistered pharmacies that ship tainted products will only be caught if contamination is reported. The FDA states it wants even greater oversight.

Heart Guidelines: Cholesterol and Blood Pressure

Major changes to the way doctors care for patients' hearts sparked controversy in 2013. In November, a cardiology expert panel issued guidelines that could boost the number of Americans taking cholesterol-lowering statin drugs. Some experts argued the calculator that accompanied these guidelines was faulty, and may result in millions receiving statins who do not need them. In December, another panel of experts issued recommendations on hypertension -- guidelines that might shrink the number of people who take blood pressure drugs. Both recommendations ignited controversy as to their validity, and debate on these issues is likely to continue.

The Morning-After Pill Debate

The controversy over who should get emergency contraceptives (EC) - and how they should get them - has ended. In April 2013, a New York federal judge ordered the FDA to make the EC pill available to all women over-the-counter (OTC) regardless of age. In May, the FDA approved Plan B One-Step (levonorgestrel) for women 15 years of age and older without a prescription. In June, the Obama administration announced it would no longer attempt to block the court order to allow OTC availability of the morning after pill. The FDA finally approved the use of Plan B One Step as an OTC emergency contraceptive regardless of the woman's age, in June 2013.

Overmedicated Kids

Overmedication of kids has been a worrisome topic in 2013. In March, an American Academy of Pediatrics paper criticized the practice of using ADHD medications -- such as methylphenidate (Ritalin) -- in healthy students solely to improve test scores. Another study showed that children in the Medicaid system, many with ADHD, were receiving off-label antipsychotic drugs five times more often than kids with private insurance. In August, research revealed that children receiving antipsychotics such as Abilify or Risperdal had triple the risk for type 2 diabetes within the first year compared to users of other psychiatric medications such as lithium or methylphenidate.

Metformin: The Wonder Drug?

Metformin is typically prescribed to lower blood sugar in people with type 2 diabetes, but has shown promise in other conditions. In July, a study found a link between metformin and a lower risk of dementia. In August, research was published that metformin may lower the risk of dying from prostate cancer, and in December metformin was found to be beneficial for heart health in women. However, not all metformin studies in 2013 were positive; one study found it does not boost survival for older breast cancer patients with diabetes, and in November, new research demonstrated that metformin won't lower the risk of heart attacks in nondiabetic patients.

A Hepatitis C-Free Future?

Hepatitis C virus (HCV) treatment was a hot pharma research area in 2013, and for good reason. Newly developed compounds are taken by mouth instead of injection, with fewer side effects and shorter treatment lengths. But add on top of that HCV cure rates are lofty in many studies, and it's easy to see why there's a race to be first in line with the new treatments. The CDC also confirmed in 2013 that all baby-boomers, a high risk group for HCV, should be tested. Both Janssen's Olysio and Gilead's Sovaldi received new HCV drug approvals in 2013. Sovaldi was dubbed a Breakthrough Therapy by the FDA - but is anything but free - costing $84,000 or $168,000 per regimen.

Rx-to-OTC Switches in 2013

There were no Rx-to-OTC switches in 2012, so it was encouraging to see two new switchs in 2013. The FDA approved Sanofi’s Nasacort (triamcinolone) for over-the-counter (OTC) treatment of nasal allergies in adults and children 2 years of age and older. Nasacort Allergy 24HR, a nasal corticosteroid, is effective for treatment of hay fever and other respiratory allergies. Merck's Oxytrol (oxybutynin) for Women was also approved as the first OTC treatment for overactive bladder in women. Oxytrol is a transdermal skin patch applied once every four days and is used to modify symptoms such as frequent urination, incontinence, and increased nighttime urination.

Blockbuster Cymbalta Goes Generic

In 2012-2013, Cymbalta had prescription sales close to $8.5 billion. In December, the FDA approved the first generic versions of Lilly’s Cymbalta (duloxetine delayed-release capsules), used to treat depression and other conditions. Generic prescription drugs approved by the FDA have the same high quality and strength as brand-name drugs and save consumers hundreds of dollars. Initially, (and unfortunately), generic prices often stay elevated due to periods of exclusivity (usually 180 days) given to many generic manufacturers. Generic versions of the antidepressant Cymbalta are now available from Dr. Reddy's Laboratories, Sun Pharma Global, Teva Pharmaceuticals, and others.

Experts: Save Your Money - Multivitamins Offer No Health Benefit

Three studies published in 2013 confirm that Americans can stop wasting their money on multivitamins. Replacing a diet lacking in vitamins with ones bought off of the shelf is a waste of money, according to studies published in the Annals of Internal Medicine in December. Evidence suggests that multivitamins offer nothing in the way of health benefits, and some studies show that high doses of certain vitamins might even cause harm. Research demonstrated that vitamins don't boost memory or help prevent death, heart disease, or strokes. Only a small benefit has been seen in lowering cancer risk. Experts suggest it is time to stop researching the benefits of vitamins, as the studies are now conclusive.

New Drug Innovation in 2013

The FDA fell short of the record 39 new molecular entities (NMEs) approved in 2012; in 2013 27 NMEs were given the go-ahead - starting with Takeda's Nesina for diabetes and finishing off with GSK's Anoro Ellipta for COPD. In between, priority drugs included Biogen's Tecfidera for multiple sclerosis, Boehringer's Gilotrif for metastatic lung cancer, and GSK/ViiV Healthcare's Tivicay for HIV. Two new hepatitis C virus drugs were approved: Olysio and Breakthrough Therapy Sovaldi, plus more new cancer drugs, including Pomalyst, Kadcyla, Xofigo, Tafinlar, and Mekinist. Others included depression treatment Brintellix, topical antifungal Luzu, and seizure drug Aptiom.

Finished: 2013 Drug News Round-Up: Top 20 Stories

New Drug Approvals in 2013: What Was Hot, What Was Not

The FDA approved 27 new molecular entities in 2013. As the year draws to a close here's an opportunity to look back at the predicted blockbusters - and those that…

 

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