Caveat Emptor: Counterfeit Drugs ‘Pop Up’ In The United States

(AP photo/Daniel Roland)

(AP photo/Daniel Roland)

If I believed in hell, I’d reserve a special suite there for the people who sell counterfeit cancer and malaria drugs. And nearby, a slightly cooler inferno for the vendors of phony Viagra, ADHD drugs and the like.

I’d long thought of counterfeit drugs as mainly a Third World problem, but a sharp new Nova report by Boston-based science journalist Barbara Moran finds that the estimated $75-billion global problem extends into the United States as well — and the cast of bad guys getting in on the counterfeiting act includes the Russian mafia, Colombian drug cartels, Mexican drug gangs, and al Qaeda:

Fueled by easy internet sales, global supply routes, and minimal punishments, counterfeit prescription drugs have become an exploding industry, with an estimated market worth $75 billion a year worldwide. Long the scourge of developing countries, fake drugs are now popping up in the United States. In 2012, a counterfeit version of the cancer drug Avastin was widely distributed in the U.S., and a fake version of the ADHD drug Adderall, in high demand because of a shortage, arrived in the U.S. through internet pharmacies.

In early 2013, the U.S. Food and Drug Administration (FDA) warned doctors that a fake version of another cancer drug, Altuzan, containing no active ingredient, was being distributed in the United States. An estimated 80% of counterfeit drugs come from overseas, and most of them are manufactured in India and China. In this era of globalization, the supply chain for genuine pharmaceuticals has grown longer, and every link offers an opportunity for counterfeiters.

Telltale signs of phoniness? This one made me smile: It’s a dead giveaway when the word “contains” is spelled “contaihs” on the box. But in many cases, you’d need an expert like Pfizer’s Amy Callanan, who examines some phony Viagra in this excerpt: Continue reading

High Use Of Stimulants On Cape Cod, Researchers Report

In a novel study examining geographic variations in the use of “mental health” drugs — stimulants, antidepressants and antipsychotics — researchers from Yale identified clear regional “clusters” where use of these types of medications was elevated. Notably, “in a large area of the South centered on Tennessee, use of… [these drugs] is 40% higher than in the rest of the United States,” researchers found.

Also notable (if you have a New England bias) is what’s going on at the Eastern tip of the Bay State: Cape Cod, the researchers found, “had the highest use of stimulants at 16% of residents, compared to a mean of 2.6% of the population nationally.”

So what’s happening on the Cape that might be driving higher-than-average use of drugs such as Ritalin, Adderall, Focalin, Strattera, Vyvanse and other medications used to treat ADHD? Is it the fried clams? The hypnotic lull of the tides? The tough winters?

A portion of Cape Cod (NASA's Marshall Space Flight Center/flickr)

A portion of Cape Cod (NASA’s Marshall Space Flight Center/flickr)

Authors found extremes in other locales as well:

Antidepressant use was highest in Alexandria, Virginia where two in five residents received an antidepressant, compared to a mean of 10.4% nationally. Gainesville, Florida had the highest use of antipsychotics at a rate of 4.6% of residents, compared to a mean of 0.8% nationally.

This study doesn’t provide clear answers on why particular regions appear to be super-users of certain meds. Still, the authors suggest several factors:

“Access to clinical care and pharmaceutical marketing explains some of the geographic variation we observed,” Continue reading

Troubled Compounding Pharmacy ‘Clean’ Room Not Clean, Inspectors Say

WBUR’s Martha Bebinger reports:


State investigators have found numerous health and safety problems at the Framingham pharmacy allegedly tied to 23 meningitis deaths, but still don’t know how fungus got into steroid vials.

Inspectors with the Department of Public Health say they found black particles in vials of steroid returned to New England Compounding Center…the steroid that has caused 23 deaths and made 304 patients in 16 states sick.

The “clean room” where the steroids were produced did not meet basic standards including untested sterilizing equipment, dirty floor entrance mats and protective hoods that weren’t cleaned.

Governor Deval Patrick, speaking at a news conference today, extended condolences to all those affected by this outbreak. He says the state will begin unannounced visits of the other 25 pharmacies that mix drugs in Massachusetts and require more specific reporting.

The state’s preliminary report is here. Continue reading

Some Walgreens Customers Must Find New Pharmacy

A dispute between Walgreens and Express Scripts over the cost of drugs will impact about 1 million consumers.

By Martha Bebinger

If you’re used to pulling into your local Walgreens to pick up a prescription, you’d better check the card you show the cashier.  Roughly a million Massachusetts residents who use their Express Scripts card to fill prescriptions can no longer do so at Walgreens.

Many employers use a separate company to track prescriptions employees fill.  Express Scripts is one of those companies.  It stopped doing business with Walgreens on January 1, claiming that Walgreens’ charges are 20% more than competing pharmacies.

Express Scripts spokesman Brian Henry says “our clients expect us to deliver a low cost high quality pharmacy benefit and having one provider whose rates are much higher than anyone elses runs counter to that.”

Henry says switching pharmacies is as easy as taking your prescription bottle to another drug store and asking the pharmacist to call Walgreens. Continue reading

Why Is There A Dangerous Shortage of Effective Cancer Drugs?

In case you missed it over the weekend, here’s a sobering opinion piece in The New York Times on the dearth of effective cancer drugs by Ezekiel Emanuel (Rahm’s brother, a former White House advisor and an oncologist who will soon be a professor of medical ethics and health policy at the University of Pennsylvania).

Emanuel writes that cancer care for adults and children is being rationed because of the severe shortage of the most effective cancer drugs. “Of the 34 generic cancer drugs on the market, as of this month, 14 were in short supply,” he notes. The piece continues:

They include drugs that are the mainstay of treatment regimens used to cure leukemia, lymphoma and testicular cancer. As Dr. Michael Link, the president of the American Society of Clinical Oncology, recently told me, “If you are a pediatric oncologist, you know how to cure 70 to 80 percent of patients. But without these drugs you are out of business.”

This shortage is even inhibiting research studies that can lead to higher cure rates: enrollment of patients in many clinical trials has been delayed or stopped because the drugs that are in short supply make up the standard regimens to which new treatments are added or compared.

The sad fact is, there are plenty of newer brand-name cancer drugs that do not cure anyone, but just extend life for a few months, at costs of up to $90,000 per patient. Only the older but curative cancer drugs — drugs that can cost as little as $3 per dose — have become unavailable. Most of these drugs have no substitutes, but, crazy as it seems, in some cases these shortages are forcing doctors to use brand-name drugs at more than 100 times the cost.

Continue reading

Supreme Court Strikes Down VT Prescription Privacy Law

The Supreme Court has just struck down Vermont’s prescription privacy law, reports Kevin Outterson, associate professor at Boston University and blogger at The Incidental Economist.

The Associated Press:

WASHINGTON (AP) – The Supreme Court has struck down a Vermont law that forbids drug manufacturers from using information about the prescription drugs doctors prescribe to tailor their sales pitches to physicians.

In a 6-3 ruling Thursday, the court ruled in favor of the data mining companies that compile the information and sell it to pharmaceutical companies.

Justice Anthony Kennedy said in his majority opinion that the Vermont law violates the speech rights of the companies.

Kevin Outterson’s bottom line, in his post here: “Vermont can fix this, but this case spells trouble for any federal or state regulation of data or information.”

The full Supreme Court decision is here, and a previous blog post — in which Kevin makes clear that he serves as counsel on the case to doctors’ groups — is here.

More from Kevin’s analysis: Continue reading

Amid A ‘Failed War On Drugs,’ The Latest Thinking On Addiction

WBUR's Deborah Becker

WBUR reporter and news host Deborah Becker is just back from a workshop on the latest information and science about addiction. The workshop took on added importance amid the recent (and now global) declarations that the American “war on drugs” has been a total failure, leaving us with millions of damaged young people and their families plus staggering incarceration costs. Here, she shares what she learned:

During the Addiction Studies Program for Journalists sponsored by Wake Forest University School of Medicine and National Families in Action, the researchers admitted that there’s still a lot they don’t know, but they said they’re confident, if not adamant, about several things. Among them: They say addiction is a chronic disease of the brain for which there is no cure; they distinguish between addiction and physical dependence; and they say the parents of adolescent boys should be very worried.

Unintentional overdose deaths from prescription drugs in the U.S. increased by more than 100% in 2008

These are just some of the staggering statistics:

More than 21 million people in the U.S. meet the criteria for needing treatment for a drug or alcohol problem and only about one million people actually think they need it.

In 16 states, including Massachusetts, drug overdose deaths now top car crashes as the number one cause of accidental deaths. In fact, unintentional overdose deaths from prescription drugs in the U.S. increased by more than 100% in 2008.

51% of all drug users are under 21 years old, with most cannabis use disorders first diagnosed in those between 15 and 19 years old.

It’s clear that we have a problem and it’s always helpful to clearly define a problem before trying to solve it — so how do these researchers define addiction? In trying to sum up two days of presentations and hoping not to grossly oversimplify, I would say the researchers define addiction as “the compulsive use of a drug even in the face of negative consequences.”

They debunk the stereotype of the addict who physically must have the substance or go through wrenching withdrawal. Although the researchers say physical dependence does precede addiction and helps maintain it, they say there also must be a psychological dependence – so the drug becomes central to a person’s life and replaces most everything else. In other words: someone is an addict when he or she considers drug-taking necessary for their well being above all else.

Virginia Guardsman disposes of tons of prescription drugs

The neuroscience is fascinating, but after the decades of destruction from all kinds of addiction – drugs, alcohol, tobacco, gambling — you would think we would, well, have it down to more of a science. Continue reading

Repeal Of Alcohol Tax Will Boost Morbidity And Mortality, Expert Says

John Kelly, associate director of the Center for Addiction Medicine at Mass. General Hospital, says repeal of the alcohol tax will cost lives

Now that Massachusetts voters have repealed the 6.25% tax on alcohol (depriving the state of about $110 million in revenue that was funding alcohol treatment programs) what will happen next?

Well, aside from making its liquor-industry backers very happy, the tax rollback will certainly fuel consumption of alcoholic beverages, which will lead to an increase in drinking-related deaths, accidents and other harms to society, according to John Kelly, associate director of the Center for Addiction Medicine at Massachusetts General Hospital.

Indeed, on Monday, the medical journal, The Lancet, published a study that found alcohol to be the most dangerous drug — surpassing heroin, cocaine, esctasy and others in terms of the harms it can inflict on society.

One of the simplest, and best known tactics in public health (and one that has been used effectively in tobacco-prevention strategies) is to raise taxes on products you want the public to avoid, Kelly says. The relationship between price and consumption is “very robust,” he says. Slap an extra tax on beer, and people reduce their drinking; repeal the tax, they reach for that Rolling Rock again.

But there’s a public health cost, Kelly says: For every one liter of alcohol that the population consumes per capita, there’s a corresponding increase in mortality of 1%. The deaths attributable to alcohol abuse are well documented in numerous studies, he notes.

It’s unclear whether the state will tap other funding streams to pay for alcohol treatment programs, or if the programs will simply be eliminated. Still, Kelly says, if taxpayers think they’re saving money in the long run, they’re wrong. That’s because all of us will still be covering the cost of emergency room visits, road accidents, alcohol-related cancers, loss of productivity in the workplace and other social problems that alcohol abuse can create.

Daily Rounds: Drug For ‘Emotional Incontinence’; Health Reform Repeal?; Early Autism Therapy; Medicare Nursing Home Ruling; Medical Pot Docs

New Drug Approved For Emotional Incontinence : NPR The Food and Drug Administration has approved the first drug that could help people like Bailey who suffer from PBA. PBA is caused when disease or injury creates a malfunction in the brain circuits involved in expressing emotion. (npr.org)

Health care repeal unlikely for GOP – The Boston Globe “Republicans are also aware that though the health care overhaul is unpopular, its component parts are quite popular. Simply repealing the entire act sounds better than allowing insurers to discriminate against children with preexisting conditions, or bringing back the days of lifetime limits on coverage, or telling insurers they do not have to cover dependents up to age 26.” (Boston Globe)

Autism Therapy Beginning at 6 Months – NYTimes.com The treatment is based on a daily therapy, the Early Start Denver Model, that is based on games and pretend play. It has been shown in randomized trials to significantly improve I.Q., language and social skills in toddlers with autism, and researchers say it has even greater potential if it can be started earlier. (The New York Times)

Medicare Coverage Standards Are Too Strict, Courts Find – NYTimes.com Two federal courts have ruled that the Obama administration is using overly strict standards to determine whether older Americans are entitled to Medicare coverage of skilled nursing home care and home health care. (The New York Times)

Medical marijuana doctors help make pot available in California – USATODAY.com Fourteen years since Californians passed the first-in-the-nation medical marijuana law, pot is not just for the sick. Hundreds of medical marijuana doctors, operating without official scrutiny, have helped make it available to nearly anyone who wants it. (USA Today)

Alcohol More Dangerous Than Heroin, Researchers Report

Alcohol does more damage to individuals and society than drugs like heroin, cocaine and ecstasy, a new study finds

NPR reports on a study published in the medical journal The Lancet online today that finds alcohol to be more dangerous than other drugs, including heroin, cocaine and ecstasy.

British experts evaluated substances including alcohol, cocaine, heroin, ecstasy and marijuana, ranking them based on how destructive they are to the individual who takes them and to society as a whole.

Heroin, crack cocaine and methamphetamine, or crystal meth, were the most lethal to individuals. When considering their wider social effects, alcohol, heroin and crack cocaine were the deadliest. But overall, alcohol outranked all other substances, followed by heroin and crack cocaine. Marijuana, ecstasy and LSD scored far lower.

Experts said alcohol scored so high because it is so widely used and has devastating consequences not only for drinkers but for those around them. When drunk in excess, alcohol damages nearly all organ systems. It is also connected to higher death rates and is involved in a greater percentage of crime than most other drugs, including heroin.