A Correction Has Been Published
Perspective
The Shortage of Essential Chemotherapy Drugs in the United States
Mandy L. Gatesman, Pharm.D., and Thomas J. Smith, M.D.
N Engl J Med 2011; 365:1653-1655
November 3, 2011
Comments open through November 9, 2011
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For the first time in the United States, some essential chemotherapy drugs are in short supply. Most are generic drugs that have been used for years in childhood leukemia and curable cancers — vincristine, methotrexate, leucovorin, cytarabine, doxorubicin, bleomycin, and paclitaxel. 1 The shortages have caused serious concerns about safety, cost, and availability of lifesaving treatments. In a survey from the Institute for Safe Medication Practices, 25% of clinicians indicated that an error had occurred at their site because of drug shortages. Many of these errors were attributed to inexperience with alternative products — for instance, incorrect administration of levoleucovorin (Fusilev) when used as a substitute for leucovorin or use of a 1000-mg vial of cytarabine instead of the usual 500-mg one, resulting in an overdose. Most cancer centers quadruple-check drugs for accuracy, and we're unaware of any documented death of a patient with cancer such as the nine deaths in Alabama attributable to the use of locally compounded liquid nutrition because the sterile product was not available. However, it is only a matter of time.
These shortages have increased the already escalating costs of cancer care. Brand-name substitutes for generic drugs can add substantial cost. For instance, Abraxane, a protein-bound version of paclitaxel, costs 19 times as much as equally effective generic paclitaxel (see table
Average Wholesale Prices (AWPs) of Selected Oncology Drugs in Short Supply and Their Potential Alternatives. ). Since 2010, health care labor costs in the United States have increased by about $216 million because of the increased time and work required to manage drug shortages. 2 A gray market for essential drugs — an unofficial alternative market of drugs obtained by vendors outside the usual distribution networks — has grown rapidly, with unregulated vendors charging markups of up to 3000% for cancer drugs.
The main cause of drug shortages is economic. If manufacturers don't make enough profit, they won't make generic drugs. There have been some manufacturing problems, but manufacturers are not required to report any reasons or timetable for discontinuing a product. Contamination and shortages of raw materials probably account for less than 10% of the shortages. In addition, if a brand-name drug with a higher profit margin is available, a manufacturer may stop producing its generic. For instance, leucovorin has been available from several manufacturers since 1952. In 2008, levoleucovorin, the active l-isomer of leucovorin, was approved by the Food and Drug Administration. It was reportedly no more effective than leucovorin and 58 times as expensive, but its use grew rapidly. Eight months later, a widespread shortage of leucovorin was reported.
The second economic cause of shortages is that oncologists have less incentive to administer generics than brand-name drugs. Unlike other drugs, chemotherapeutics are bought and sold in the doctor's office — a practice that originated 40 years ago, when only oncologists would handle such toxic substances and the drugs were relatively cheap. A business model evolved in which oncologists bought low and sold high to support their practice and maximize financial margins. Oncologists buy drugs from wholesalers, mark them up, and sell them to patients (or insurers) in the office. Since medical oncology is a cognitive specialty lacking associated procedures, without drug sales, oncologists' salaries would be lower than geriatricians'. In recent decades, oncology-drug prices have skyrocketed, and today more than half the revenue of an oncology office may come from chemotherapy sales, which boost oncologists' salaries and support expanding hospital cancer centers.
Before 2003, Medicare reimbursed 95% of the average wholesale price — an unregulated price set by manufacturers — whereas oncologists paid 66 to 88% of that price and thus received $1.6 billion annually in overpayments. 3 To blunt unsustainable cost increases, the Medicare Modernization Act mandated that the Centers for Medicare and Medicaid Services (CMS) set reimbursement at the average sales price plus a 6% markup to cover practice costs. This policy has reduced not only drug payments but also demand for generics. In some cases, the reimbursement is less than the cost of administration. For instance, the price of a vial of carboplatin has fallen from $125 to $3.50, making the 6% payment trivial. So some oncologists switched to higher-margin brand-name drugs. 4 Why use paclitaxel (and receive 6% of $312) when you can use Abraxane (for 6% of $5,824)?
Now practices are struggling to treat their patients because of the unavailability of drugs. Short-term solutions include gray-market purchases, which more than half of surveyed hospitals say they've made, but that option introduces safety and quality-control issues. Pharmacists are intensively managing inventories and alerting prescribers to developing shortages and potential alternatives. Some centers now have a red–yellow–green system for quickly recognizing developing shortages and determining which patients get priority (usually those with curable cancers) when supply is limited.
Long-term, non–market-based solutions have been elusive. Proposed legislation would require manufacturers to give 3 to 6 months' notice before discontinuing a drug in order to allow others to pick up production. However, it is likely that gray-market vendors would buy the remaining inventory of such drugs and charge huge markups. Creating a national stockpile is impractical: Do we stockpile the drugs and then waste whatever is not used or stockpile the ingredients and make new batches as needed? A national health care plan with a single formulary and a central pharmacy stockpile is possible for Medicare or Veterans Affairs but unrealistic given oncologists' dependence on drug income and difficulties with timely, safe distribution.
Market solutions take one of two approaches: let the market work and accept short-term uncertainties or regulate the market more tightly. For instance, the CMS could reimburse at the average sales price plus 30%, but that wouldn't help if the drug price has fallen from $125 to $3.50 per vial. The government could set a floor for average sales prices to encourage the production of generic drugs, but that would increase the total cost of cancer drugs unless brand-name prices were reduced. Europe has fewer shortages for that reason: prices are set higher for generics so that companies will make them, but prices of brand-name drugs are often much lower than U.S. prices.
More far-reaching reforms of oncology practices and reimbursement are necessary if there is no national intervention or federal market regulation. One solution is adopting clinical pathways for which practices are paid disease-management fees that are not based on chemotherapy sales. For instance, one large oncology group has developed care pathways specifying preferred drug combinations and sequences — for example, allowing only a few first-line, mostly generic regimens for patients with non–small-cell lung cancer, as compared with the 16 possible drugs and many more combinations included in National Comprehensive Cancer Network pathways. This approach has been shown to result in equal or better survival, less use of chemotherapy near the end of life, and 35% lower costs than usual care. 5 Another solution is to pay physicians salaries, as Kaiser Permanente, Veterans Affairs, and most academic centers do, but that would reduce oncologists' earnings at a time when a 40% workforce shortage is predicted, so the effect must be monitored.
To ensure a predictable supply of generic cancer drugs, manufacturers need reasonable markets and profits, and oncologists need incentives to use generics. Standardized clinical pathways with drug choices based only on effectiveness will enable the prediction of drug needs, practices for effective management of inventory, and planning by manufacturers for adequate production. Such pathways, disease-management fees, and physician salaries would dramatically change oncologic practice, but since drug costs will increase by 4 to 6% this year alone, they are necessary. The current system not only is unsustainable but also puts oncologists in potential ethical conflict with patients, since it hides revenue information that might influence drug choices and thus affects costs and patients' copayments.
The only good news is that the drug shortages may catalyze a shift from a mostly market-based system to one that rewards the provision of high-quality cancer care at an affordable cost.
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
This article (10.1056/NEJMp1109772) was published on October 31, 2011, and updated on November 2, 2011, at NEJM.org.
Source Information
From the Virginia Commonwealth University Health System, Richmond (M.L.G.); and the Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medicine, Baltimore (T.J.S.).
The 11 Most Expensive Medicines in America
Posted on February 6, 2012
Think you pay way too much for your monthly
prescriptions? These amazingly expensive drugs may put things into perspective. Paying $10,000 or even $30,000 in annual prescriptions might be busting many peoples’ budgets, but those price tags pale in comparison to some that come in at over $400,000 for an annual treatment.
So why isn’t someone doing something about this obvious highway robbery? How could the FDA let evil pharmaceutical companies get away with this? The truth is that these are often lifesaving drugs that would not exist if it were not for their incredible cost. To be fair, pharmaceutical companies spend an amazing amount of money to make highly specialized drugs, often in the range of hundreds of millions of dollars. As such, the FDA supports this practice with the
Orphan Drug Designation program, which encourages the development of drugs for rare diseases that, without special protections and benefits, might not ever be developed. While patients may be losing their shirts to the pharmaceutical companies, they are at the same time lucky not to lose their lives thanks to these drugs. Still, it is quite interesting to marvel at the sheer cost of annual treatment, and we’ve compiled a list of 11 mind-bogglingly expensive medicines being used to treat conditions in America right now.
Soliris
Soliris has been made famous by Forbes as the
world’s single most expensive drug, coming in at $409,500 a year. Soliris is used to treat paroxysmal nocturnal hemoglobinuria, a rare blood disease that affects 8,000 Americans. Soliris’ high price tag is largely due to $800 million investment and 15 years of research that Alexion Pharmaceuticals put into its development. Its 2009 sales were $295 million, and in 2010, Alexion pulled in $541 million for the drug. The high cost of Soliris is shocking, but it does seem to be worth every penny: studies show that Soliris use results in a 90% reduction in the most serious complication and cause of death from paroxysmal nocturnal hemoglobinuria.
Elaprase
Patients who suffer from
Hunter syndrome, an inherited disease caused by a lack of the enzyme iduronate sulfatase can find relief in the recombinant form of this enzyme, but at an incredibly high price of $375,000 each year. Some estimates put its annual cost as high as $657,000. Each vial of the drug is reported to cost $4,215 each, and in the U.S. alone, the 500 Americans who suffer from Hunter syndrome spent a combined $353 million on Elaprase in 2009.
Naglazyme
Naglazyme is right behind Elaprase’s reported $375,000 price tag, coming in at the bargain price of just $365,000. This purified human enzyme is used to treat Maroteaux-Lamy syndrome, a rare genetic metabolic condition that typically presents itself in childhood through growth retardation in intellectually normal toddlers, and can cause tissue damage and mental retardation. The administration of the drug improves growth and joint movement, as well as range of motion and pain management.
Cinryze
Patients with
hereditary angioedema suffer from severe swelling, often in the face and airways, caused by low levels or improper function of the C1 inhibitor protein. This condition is hereditary, and there’s usually a family history, but often, deaths from hereditary angioedema go undiagnosed and reported as a sudden and premature death of a family member. This makes the condition relatively rare, and the treatment is quite expensive: an estimated $350,000 per year for Cinryze, an injectable man-made protein form of complement C1 esterase inhibitor. Cinryze maker Viropharma has mapped out yearly sales of the drug ranging from $95 million to as much as $350 million.
Folotyn
Getting cancer is bad enough, but things just get even worse when the cost of treating such a severe disease begins to sink in. Patients with T-cell lymphoma typically turn to Folotyn when their cancer has not improved with treatment, or comes back. This drug works by killing cancer cells, and has a short course of treatment. Typically, patients will take the drug for about six weeks, but even in that short amount of time, the bill for this treatment is staggering — around $30,000 per month.
ACTH
If you think $30,000 per month is insane, consider this: it’s a bargain compared to the approximate $115,000 per month families pay for ACTH. This drug is used to treat
infantile spasms, seizures that often affect infants 4 to 6 months of age. Daily injections of ACTH are given for a period of weeks up to several months. At $23,000 per vial, patients often use 6 to 7 vials per course, and often go through two courses, which adds up to more than $300,000 in prescription drug bills. Unfortunately,
ACTH is not FDA-approved to treat infantile spasms, and that means families may have trouble getting their insurance companies to pay for this mind-boggling bill.
Myozyme
Developed by Genzyme, Myozyme costs up to $100,000 per year for child treatment, and about $300,000 per year for adults. Myozyme was created to treat a rare and often fatal disease, Pompe, which disables the heart and skeletal muscles. Often affecting infants, most of its sufferers die in the first year, and those who do survive typically need assistance like ventilators and wheelchairs. But thanks to Myozyme, some patients can do fairly well with the disease, able to speak, walk, and feed themselves. The drama behind creating such an expensive, yet lifesaving drug, was depicted in the movie
Extraordinary Measures, sharing the race against time and profit motives experienced in the drug’s development.
Arcalyst
Rare genetic conditions like Familial Cold Auto-inflammatory Syndrome and Muckle-Wells Syndrome are inflammatory disorders that cause the body to develop symptoms without a known cause, including virus and illnesses, and can affect the bones, joints, and major organs, leading to deafness, kidney impairment, and vision loss. These inherited conditions impair the immune systems of sufferers, but with Arcalyst, the symptoms associated with these syndromes can be treated and even prevented. It’s even been found to
help prevent gout flares, but all of this helpful treatment comes at a very high cost: a
reported $250,000 per year of treatment.
Ceredase/Cerezyme
Patients with Gaucher disease, a condition that causes lumps of fat to build up in various places in the body, including the heart, brain, and spleen, suffer from the disease due to a missing enzyme. With Ceredase, made from human placentas, that enzyme can be replaced. But placentas don’t come cheap: the price of this drug is $150,000 per year. A new version, Cerezyme, came out in 1994, made with genetically engineered hamster cells, and was expected to be cheaper, but unfortunately for Gaucher disease sufferers, the price has actually gone up to $200,000 per year for the average patient. The drug has annual sales of more than a billion dollars.
Fabrazyme
Like so many other terribly expensive drugs on this list, Fabrazyme replaces a necessary enzyme in the human body. Patients with
Fabry disease suffer from the lack of or faulty enzyme that is needed to metabolize lipids. Without it, lipids are not effectively broken down, and can build to harmful levels in the nervous system, cardiovascular system, eyes, and kidneys, leading to cloudiness of the cornea, increased heart attack and stroke risk, as well as an enlarged heart and impaired kidneys. It’s not hard to understand why this condition is just downright harmful, and why it’s so important to treat. Using Fabrazyme, patients can make up for their enzyme deficiency, reducing deposits throughout the body. The treatment is
reported to cost $200,000 for a year of treatment, that is, if you can get it: in 2009, Fabrazyme maker
Genzyme’s plant was shut down due to contamination, and is just now resolving its manufacturing problems.
Aldurazyme
Aldurazyme is used to treat a genetic enzyme condition, a far too common and expensive issue on this list. The condition in this case is
Hurler syndrome, a metabolic disorder in which the lack of an enzyme keeps the body from breaking down certain sugars and proteins properly. Like Fabry disease, sugars and proteins not broken down will build up, leading to enlarged organs, breathing issues, decreased physical abilities, and more. With Aldurazyme, breathing and walking ability can be improved, but it does cost a pretty penny: $200,000 per year. The drug is usually given on a weekly basis in a clinic or hospital setting, which may incur additional costs as well.
documents implicating Taco Bell as the restaurant likely involved in the 10-state outbreak, first reported by the Centers for Disease Control and Prevention (CDC) on January 19. The CDC's summary outbreak report referred to the restaurant only as "Restaurant Chain A" and linked it to a cluster of Salmonella enteritidis infection that had sickened at least 68 individuals. The document provided by the Michigan health department summarizes statistics from a case-control study comparing outbreak victims with a control group. In interviews, 29 out of 48 victims (62 percent) reported eating at Taco Bell during the outbreak window, versus 17 out of 103 respondents (17 percent) from a general population control group taken from the ten states involved in the outbreak. The investigation compared those numbers against other fast food chains, none of which received the large disparity shown in the Taco Bell comparisons. Statistically, the study estimated an odds ratio of 9.24 to 1 that Taco Bell distributed the food contaminated with Salmonella enteritidis. CDC investigators believe the illnesses resulted from an ingredient distributed by Taco Bell that was contaminated before reaching restaurants, although the investigation could not pinpoint a single suspect ingredient. Of the victims who ate at Taco Bell, 94 percent reported eating ground beef, while 90 percent ate lettuce and 77 percent ate cheese. University of Minnesota environmental health professor Craig Hedberg, Ph.D., said that the document's data show a "reasonably strong" association between Taco Bell and the illnesses. "Elevated odds ratios and confidence intervals such as these do not prove causation, but would certainly support the hypothesis that the contaminated food item was distributed by Taco Bell to its customers," Hedberg said. Michigan reported one illness associated with the outbreak, though an epidemiologist at the Michigan Department of Community Health said the victim had not eaten at a Taco Bell during the outbreak window. Food Safety News could not confirm whether the victim had been traveling when he or she contracted Salmonella enteritidis.
The mystery behind the identity of "Restaurant Chain A" prompted some public health experts and consumers to question the transparency policies of the agencies involved in the investigation. In a response to inquiries about the Food and Drug Administration's transparency policy in such outbreaks, the FDA issued this response:
"FDA strives to provide reliable information and be as transparent and proactive as possible, particularly when there is an issue that threatens the public health," the statement read. "In situations where there are current illnesses associated with a specific food manufactured by a specific firm, or contaminated foods are distributed without known illnesses, FDA will continue to issue health advisories and press releases, as needed, to provide consumers with specific information so they may take steps to decrease their risk of illness and avoid further exposures."
"We will also continue to work with CDC and State health officials to provide support during their investigations," it added. "We are currently re-examining our practices and policies to ensure they will provide as much transparency as possible while adhering to laws and regulations." On February 1, Food Safety News received documents from the Oklahoma State Department of Health naming Taco Bell as "Restaurant Chain A," providing the first confirmation of the restaurant's identity. With 16 confirmed illnesses, Oklahoma had the second greatest number of outbreak-related cases behind Texas, which had 43. Following the release of the CDC's summary report on January 19, Food Safety News sent public records requests to the CDC, the FDA and the 10 state health departments involved in the outbreak, asking health officials for the name of the fast food chain and the locations of the three restaurants where more than one victim ate. The 10 states involved in the outbreak were: Texas (43 illnesses), Oklahoma (16), Kansas (2), Iowa (1), Michigan (1), Missouri (1), Nebraska (1), New Mexico (1), Ohio (1), and Tennessee (1). The state health departments in Nebraska and Texas have cited confidentiality for their denials of the records request. Iowa and Ohio said they did not have information on the identity of the restaurant, while the remaining state health departments have not yet responded to records requests and phone calls. The CDC has also yet to respond. For more than a week, Food Safety News has placed multiple phone calls to Taco Bell's public relations division asking for additional information on how the restaurant chain responded to the outbreak. After repeated promises to respond, Taco Bell has still not returned any calls. On Monday morning, a Taco Bell representative said the company is busy responding to many inquiries, but would put a priority on responding to Food Safety News.
The ractopamine dispute is front page news in Taiwan. The country's newly sworn in cabinet will discuss the contentious dispute at its first meeting later this week and President Ma has already publicly discussed the issue, according to local media reports.
"We have always maintained the same position as U.S. officials -- that Taiwanese have concerns about U.S. beef imports and the use of ractopamine," said Ma, at a recent press conference.
The opposition party has been especially outspoken against lifting the ban on ractopamine.
"No meat products, whether beef, lamb, pork or chicken, should be allowed into Taiwan if it contains leanness enhancers," said one lawmaker, according to
Focus Taiwan.
Taiwan, which is the sixth largest export market for beef and pork, began testing U.S. beef for ractopamine in January 2011 and within days found trace levels of the drug. U.S. food safety officials said the levels found ranged from 2.4 to 4.07 parts per billion (ppb), which falls below both the U.S. Food and Drug Administration standard, of 30 ppb, and the proposed international standard of 10 ppb, but Taiwanese officials pulled the meat from the shelves of grocery stores, including Costco, citing consumer concerns.
In early June, Taiwan rejected nearly 100 tons of frozen U.S. beef after it tested positive for ractopamine at 1.5 ppb. Ten days later, Burger King Taiwan temporarily suspended sales of products containing bacon after the Taiwan Department of Health found U.S.-imported pork products to contain ractopamine and seized the pork before hitting grocery store shelves. Public health officials said they found 3 ppb in fully cooked bacon products. Burger King declined to comment on the matter.
The issue has strained the U.S.-Taiwan trade relationship. Taiwan's policy on ractopamine is often cited as a primary reason the two countries have tabled bilateral Trade and Investment Framework Agreement talks. U.S. officials maintain that Taiwan's policy is not science-based.
With renewed pressure from Washington to lift the ban, consumers and farmers are threatening protest, according to Focus Taiwan.
Ractopamine, a drug made by Elanco, a division of Eli Lilly, was first approved by the FDA for pork production 1999, it has since been approved in 25 other countries. The drug has sparked long-running trade conflicts beyond the U.S.-Taiwan hangup.
A recent
msnbc.com report, produced by the Food and Environment Reporting Network, described the deadlock between China, the European Union and the United States at the Codex Alimentarius Commission, which sets global food safety standards.
"The EU and China, which together produce and consume about 70 percent of the world's pork, have blocked the repeated efforts of U.S. trade officials to get a residue limit European scientists sharply questioned the science backing the drug's safety, and Chinese officials were concerned about higher residues in organ meats, which are consumed in China."
High level controversy at Codex is rare. Though the commission adopts dozens of standards each year by consensus, Codex has been stalled on a residue standard for ractopamine since 2008.
"U.S. trade officials say China wants to limit competition from U.S. companies, and the EU does not want to risk a public outcry by importing meat raised with growth-promoting drugs, which are illegal there," added the report.
"Setting a Codex standard for ractopamine would strengthen Washington's ability to challenge other countries' meat import bans at the World Trade Organization."
While ractopamine use remains controversial abroad, there is little awareness in the United States, even though there have been issues with the drug.
"Although few Americans outside of the livestock industry have ever heard of ractopamine, the feed additive is controversial. Fed to an estimated 60 to 80 percent of pigs in the United States, it has sickened or killed more of them than any other livestock drug on the market, an investigation of Food and Drug Administration records shows."
The full
Food and Environment Reporting Network story, which was also been
picked up by Taiwan media, can be found
here.
On January 9, the U.S. Department of Agriculture announced it would close 259 offices, laboratories and other facilities to save $60 million in its $145 billion budget. These closings include five of the 15 Food Safety Inspection Service (FSIS) offices. FSIS is responsible for ensuring meat, poultry and egg safety. USDA undersecretary Dr. Elisabeth Hagen said, "There will be no reduction in inspection presence in slaughter and processing facilities and no risk for consumers." Unfortunately, previous inspector cutbacks and FSIS rules to limit the number and detail of inspector reports on industry non-compliance do put consumers at risk, as a recent 36-million pound meat recall attests.
Aside from closing offices, the budget cutting axe has weakened agencies in charge of protecting public health. In November, the U.S. Food and Drug Administration stated it cannot afford to withdraw the many animal drugs used non-therapeutically in livestock feed to promote growth and prevent disease. Non-therapeutic use, resulting in meat laced with antibiotic residues, is a factor in increasing human antibiotic resistance. FDA, responding to petitions by medical associations and non-governmental organizations, the first of which were filed in 1999, alleged that the withdrawal of just one drug used in poultry production took five years and $3.3 million, due to industry legal resistance. Instead, FDA proposes to begin a program with animal drug manufacturers to phase-out some drugs voluntarily. Keep Antibiotics Working (KAW), a coalition to which IATP belongs, wrote to FDA protest that the decision violated FDA's public health mandate.
In September, USDA announced that budget cuts would curtail or end data collection and reporting on pesticide use on fruits, vegetables and in livestock pens by the National Agricultural Statistics Service (NASS). NASS surveys are used to help formulate food and farm worker safety policy. In November, NASS announced cutbacks to its survey of pesticide and fertilizer use on field crops. Non-governmental organizations protested the cutbacks, saying that the public would be forced to rely on pesticide and fertilizer companies for unverified reporting about agricultural chemical use.
Our thin budgetary margin for error in curtailing the spread of foodborne illness was brought home forcefully by the U.S. Centers for Disease Control and Prevention (CDC). The CDC (and its state partners, especially in Colorado) took justifiable pride in tracing back a Listeria monocytogenes infection to the packing facility of a melon farm in Colorado just 10 days after the initial hospital report of listeriosis, which had led to 29 deaths by the end of November.
Thomas Frieden, the CDC director, noted in a recent speech that his agency had absorbed the biggest budget cuts in its history in 2010 and 2011. (The U.S. House of Representatives is promising further cuts to the 2012 budget.) Furthermore, "there are 44,000 fewer people working at the state and local level because of the fiscal crisis" in the public health professions. As a result, in Colorado, college students used their own cell phones and a CDC questionnaire to interview those afflicted with listeriosis. The students helped to trace back to a single farm the source of the Listeria, doing work that had previously been done by public health officials. "How many more cuts to food safety?" -- before students equipped with cell phones and a CDC questionnaire cannot trace back the source of foodborne illness before many more than 29 people die? It should not take a spike in death or illness from foodborne disease to shock us into recognition that food safety is not cheap, nor can food safety be self-regulated among competing companies. Systematic failure to regulate the financial services industry resulted in ongoing bailouts that have forced FDA and other agencies to claim that rules to protect public health are too expensive, despite plenty of evidence to show the economic and human suffering costs of food safety failures.
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Dr. Steve Suppan has been a policy analyst at the Institute for Agriculture and Trade Policy (IATP) since 1994.
"Food Fraud is a much broader set of crimes than just counterfeiting or adulteration," says John Spink, the associate director of Michigan State University's Anti-Counterfeiting and Product Protection Program. "The term Economically Motivated Adulteration has been used by [the U.S. Food and Drug Administration], and although there has been a lot of activity using this term in the food industry, it actually involves all FDA regulated products."
Spink and Douglas Moyer, both faculty at Michigan State University, published a paper in the Journal of Food Science in November specifically aimed at defining the public health risks of food fraud, hoping to provide a base reference for the issue and help shift the current focus on intervention to one of prevention.
"The food-related public health risks are often more risky than traditional food safety threats because the contaminants are unconventional," write Spink and Moyer. "Current intervention systems are not designed to look for a near infinite number of potential contaminants."
As it stands now, food fraud crackdowns often focus on the economic impact of cheating the system, not public health, and are reactive, not preventative.
In late November, European Union's Europol teamed up with Interpol to conduct a week-long, multi-country food fraud operation. Agents seized hundreds of tons of fake and substandard food and drink--including champagne, cheese, olive, oil, and tea--from Bulgaria, Denmark, France, Hungary, Italy, The Netherlands, Romania, Spain, Turkey and the United Kingdom.
Known as "Operation Opson," the effort, which took six-months to plan, ultimately turned up a lot of fraudulent food.
The team seized 13,000 bottles of substandard olive oil, 30 tons of fake tomato sauce, around 77,000 kg of counterfeit cheese, more than 12,000 bottles of substandard wine worth 300,000 EUR (or nearly $400,000), five tons of substandard fish and seafood, and nearly 30,000 counterfeit candy bars. Authorities also said the sale of fake or substandard caviar on the internet was under investigation.
Interestingly, when Interpol-Europol announced the results, they specifically cited public health as a key reason to crack down on fraudulent food practices.
"Consumers buying these goods, either knowingly or unknowingly, are putting their health at risk as the counterfeit food and drink are not subject to any manufacturing quality controls and are transported or stored without proper regard to hygiene standards," authorities said about the operation.
Interpol-Europo said Operation Opson, which means "food" in ancient Greek, had three critical goals:
- Raise awareness of the dangers posed by counterfeit and substandard foods;
- Establish partnerships with the private sector to provide a cohesive response to this type of crime;
- Protect consumers by seizing and destroying substandard foods and identifying the criminals behind these networks.
"One of the main goals of this operation was to protect the public from potentially dangerous fake and substandard food and drinks, which is a threat that most people are not even aware of," said Simone Di Meo, Criminal Intelligence Officer with Interpol's Intellectual Property Rights programme and coordinator for Operation Opson.
Explicitly linking fraudulent or substandard food to public health risk is something Spink and his team at Michigan State University would like to see happen here in the United States more often.
"I find it amazing, and refreshing, that Interpol-Europol have focused this Operation Opson on a underappreciated product risk. Most times, consumers and even lawmakers, consider product counterfeiting to be a technical problem with economic losses. While they may understand the risks of pharmaceutical drug counterfeiting, they are often unaware of the food risks," said Spink. "Any and every type of food fraud has a public health vulnerability - we may not have experienced an actual public health incident, but the bad guys are not following good manufacturing practices."
Photo courtesy of Europol.
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The U.S. Food and Drug Administration (FDA) is getting increasingly bold these days with openly admitting that it works directly for big industry interests rather than public health interests. In a recent report on why the agency did not disclose Taco Bell as being the... |
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