650% price hikes for prescription drugs, White House confronts gouging

By  Charlene Smith

Washington, D.C. – A trebling of prescription drug shortages over the past five years is seeing price gouging for some essential medications, the White House has revealed.

It gave examples:

* “The ranking member of the House Committee on Oversight and Government Reforms, when announcing his investigation into so-called gray markets, expressed concerns about a report that a leukemia drug whose typical contract price is about $12 per vial was being sold at $990 per vial – 80 times higher.  

*  "A Premier healthcare alliance report released in August estimated that the typical gray market vendor marks up prices by an averaged 650 percent.  

*  "A drug used to treat high blood pressure that was normally priced at $25.90 was being sold at $1,200 due to a drug shortage.” 

It noted that, “the number of reported prescription drug shortages in the United States nearly tripled between 2005 and 2010. While FDA successfully prevented 137 drug shortages between January 1, 2010 and September 26, 2011, prescription drug shortages continue to threaten the health and safety of the American people." 

President Barack Obama said: “I am directing my administration to take steps to protect consumers from drug shortages, and I’m committed to working with Congress and industry to keep tackling this problem.”

He signed an Executive Order directing the Food and Drug Administration (FDA) to broaden reporting of potential shortages of certain prescription drugs and to expedite regulatory reviews. Under the President’s order, FDA will work with to the Department of Justice, to examine whether potential shortages have led to illegal price gouging or stockpiling of life-saving medications.

Currently, the FDA can only require drug manufacturers to disclose the discontinuation of a critical drug when the drug is available through a single manufacturer. The President’s Executive Order directs the FDA to take additional steps to require drug manufacturers to provide adequate advance notice of manufacturing discontinuances or other actions that could lead to critical shortages.

DO THE DRUGS WORK?

“There is nothing to fear, but fear itself,” Franklin Delano Roosevelt, US President

By Charlene Smith
“People obtain considerable benefits from many medications, but they also can experience symptom improvement just by knowing they are being treated. This is called the placebo effect.”[1]
John Teasdale, a leading researcher on depression at Oxford and Cambridge universities writes that most depressed people will say they are depressed about being depressed.

Professor Irving Kirsch writes, he “labeled this phenomenon, ‘depression about depression’ and claimed that effective treatments for depression work – at least in part – by altering the sense of hopelessness that comes from being depressed about one’s own depression.” Hope, is said, lies at the core of the placebo effect.

A psychologist with many years of experience, he has analyzed 38 clinical trials with more than 3,000 patients over 15 years. He found that people get better when given placebos, “although not as great as the improvement following drugs or psychotherapy” which had similar rates of success.

Tom Moore performed similar evaluations of data from the Food and Drug Administration that found that about 50% of the “effects of a pain medication can also be produced by placebos, whereas the placebo effect in drugs used to treat blood-sugar levels is nil.”  Kirsch notes that “conditions that have a strong psychological component – such as pain, anxiety and depression – are particularly prone to placebo influence, whereas conditions like bone fractures, diabetes and infertility are less likely to be affected by placebo treatments.”

The human mind is so powerful that when patients on a clinical trial are told that the side effects of an antidepressant are a dry mouth, drowsiness, diarrhea, nausea and forgetfulness even those receiving placebos (sugar-coated pills with no drugs) experience the same side effects.

But there are also times when drug companies deliberately distort information and organizations that the public believe are acting on their behalf, like the World Health Organization and the Federal Drug Administration, may often be compromised with key researchers in the pay of drug companies.

Kirsch writes, “One might expect to find a negative association between side effects and improvement. Side effects of SSRIs include sexual dysfunction, insomnia, short-term weight loss, long-term weight gain, diarrhea, nausea, drowsiness, skin reactions, nervousness, anorexia, dry mouth and sweating. One would think that experiences like this would make people feel more depressed. Indeed, some of these side effects could also be interpreted as symptoms of depression. But in fact… the more side effects a person experiences when taking Prozac, the more he or she improves on the drug. I can think of only one reason … and that is (because the side effects) lead patients to conclude that they have been given the active drug, rather than the placebo.”

Kirsch notes that the conventional view of depression, “is that it is caused by a chemical imbalance in the brain … it is actually a rather controversial theory and there is not much scientific evidence to support it.”

Psychologist, Michael Brown of Minneapolis who has been in practice for more than three decades and lectures psychiatry students says that it is human interaction and not drugs that are most likely to see a turn-around in patient moods.

“It is being listened to, heard, cared about that causes the greatest change and not drugs which may make a bad situation worse.” 

It is a view Kirsch would support.

Brown is vociferous about the way pharmaceutical companies profit, in his view, from human misery using drugs that are not very effective and points to a litany of failed psychiatry methods over the years, some of which, in today’s world would be seen as human rights abuses and even torture.[2]

Indeed, drug companies are active in suppressing negative results from clinical trials and only publishing positive results. Kirsch cites the example of Glaxo Smith Kline’s research in the 1990s into paroxetine, which is sold under the brand name of Seroxat for major depression in children and adults. One study showed mixed results, a second showed no real difference between placebo and drug and a third suggested that the placebo might be more effective for children aged seven to 11. Only one trial was published. The Canadian Medical Association Journal published a confidential GSK memo which noted that: “it would be commercially unacceptable to (note) that efficacy had not been demonstrated, as this would undermine the profitability of paroxtene.” They released the drug and the mixed results study in 2001 with the statement that “paroxtene is effective for major depression in adolescents.”[3]

Or drug companies cherry pick data, Kirsch gives the example of a multi-center study of Prozac presented to the FDA showing a drug-placebo effect of three points on the Hamilton scale. “When data from this clinical trial was published, the difference was reported as 15 points – a five times increase in effectiveness. How was this magical augmentation of the benefits of Prozac accomplished? The full study was conducted on 245 patients. The published paper reported data from only 27 of these patients … making the drug seem much more effective than it really was.”

He also gives the example of the regulatory agencies of the European Union, France, the Netherlands and Sweden who issued a ‘regulatory apologia’ after research from Kirsch and his colleague Guy Spairstein came out in a meta-analysis in 2008. “’Against this background,” the wrote, “one can ask why the new-generation antidepressant medicinal products were ever approved.’”  The regulatory agencies conducted their own research and found similar results to Kirsch indicating that the drugs were only effective in 16 percent of cases.

Commonly abused antidepressants
Brand Names US

Prozac

Paxil

Zoloft

Effexor

Serzone

Celexa

Caution

Do not come off anti depressants or painkillers without medical supervision. The abrupt cessation of SSRIs produces withdrawal symptoms in 20 percent of patients. These included abdominal cramping and pain, diarrhea, nausea, vomiting, dizziness, flu-like symptoms, anxiety, depression, blurred vision, numbness, sleep disturbances, electric shock symptoms, headaches, twitches and tremors.  The book Coming Off Antidepressants by Joseph Glenmullen of Harvard Medical School is an excellent source of information on how to discontinue antidepressant drug treatment.

Alternatives:

Psychotherapy.

St John’s Wort but be careful about not taking too much. 

Physical exercise.

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[1] The Emperor’s New Drugs: Exploding the Antidepressant Myth by Irving Kirsch, Ph.D., Basic Books, New York, 2010

[2] Correspondence and discussions with Michael Brown, Minneapolis, February to April, 2011

[3] In 2004, Eliot Spitzer then Attorney General of New York sued GlaxoSmithKline charging that the company had ‘engaged in repeated and persistent fraud by concealing and failing to disclose to physicians information about Paxil (the brand name for Seroxat in the US).’ The case was settled two months later, with the company agreeing to pay $2.5 million to the State and to establish an online clinical-trial register containing summaries of the results of all of the clinical trials they sponsor.

Opioid painkiller addiction - the Stealth bomber in the living room

by Charlene Smith

Americans addicted to opioid painkillers have all but killed the cocaine trade as the citizens of the United States, just four percent of the world’s population, consume half the global output of prescription drugs.  And 80 percent of its painkillers.

Marijuana is no longer the gateway drug for teens - it is prescription drugs.

Cocaine is no longer the party thrill - it is prescription drugs.

And for kids who are persuaded by parents and teachers that they can’t study or concentrate appropriately without Ritalin, they switch to Adderall at college when writing papers – both drugs are ranked as narcotic as cocaine by the Drug Enforcement Administration, and both are cardio-toxic, which means they can cause potentially lethal heart problems.

The profile of prescription drug addicts is different to that of street addicts – your classic prescription drug addict is a white male aged 30 to 60. He is educated, employed, and probably a family man. His wife and children also probably use a higher ratio of prescription drugs than necessary.  And the more prescription drugs children are exposed to as they grow up, the more likely they will become addicted. Prescription drugs and not marijuana are the new gateway drugs to addiction and hard-core illegal drugs like heroin, the granddaddy of opioids.

And talking of senior citizens, grandma or grandpa also probably consume 10, 15, 20 or more drugs a day as globally the most rapidly growing age group is that aged 80 and older – with the assumption, not always correct, that as they age they need more and more drugs to function.[i]

Prescription drug addiction is not confined to the U.S., Britain, Australia and Canada are all reporting alarming increases in prescription drug consumption and addiction, but the problem is worst here.

Why are so many Americans in such pain[ii], so troubled and finding it so difficult to cope with life?  One of the reasons may be that, according to research from Harvard economists and others, this country has become one of the most over-worked nations in the world. Americans tend to work longer hours than the global norm with less labor protection. American productivity ranks among the top three in the world but the excessive consumption of pharmaceutical products to sleep, perform (at school, college, work and in bed) and retain a calm disposition would suggest that high rates of workplace performance are achieved at a cost that is disabling the country.

Dr. David Martin head of the Washington-based Drug and Alcohol Testing Industry Association receives daily reports of drug test results taken of employees in corporations and federal institutions. He says[iii] the U.S.A. is “facing a tsunami of severely addicted people.” He also gets to see drug test results for children and comments: “We are sacrificing a generation of children. We give them pills that look like vitamins. When I was growing up about six percent of 12-year-olds had some exposure to drugs, now over 60 percent are exposed to some form of drug abuse. I can’t think of a scarier science fiction plot … ”

What the United States needs to get out of the global recession is not for Americans to work harder – you can’t keep flaying a dying horse – it is for legislators and corporate bosses to become smarter about a risk that is rising up behind them like a Stealth bomber.  While everyone has their faces to the balance sheets, they’re ignoring the fact that the American worker can no longer cope, whether on the trading floor or on the manufacturing line.  They’re exhausted and are consuming chemicals in such high quantities that it is starting to paralyze innovation (the U.S. now ranks bottom in a ranking of 40 nations [iv]); destroy educational outcomes (U.S. educational scores are at record lows[v]) and collapse the health system.

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[i] World Population Ageing 1950 to 2050, Population Division, Department of Economic and Social Affairs, United Nations, 2002: “In the more developed regions, the proportion of older persons already exceeds that of children, and by 2050 it is expected to be double that of children.”

[ii] More than 33 million Americans, age 12 and older, misused extended-release and long-acting opioids during 2007—up from 29 million just five years earlier. In 2006, nearly 50,000 emergency room visits were related to opioids, by 2009 that figure had leapt to 1,2 million emergency room admissions. (Federal Drug Administration, April 2011)

[iii] Telephone interview with Dr. Martin, June 7, 2011

[iv] GPS Innovation Special, Fareed Zakaria, CNN, June 13, 2011

[v] The three-yearly Organization for Economic Cooperation and Development Program for International Student Assessment (PISA) report, which compares the knowledge and skills of 15-year-olds in 70 countries around the world, ranked the United States 14th out of 34 OECD countries for reading skills, 17th for science and a below-average 25th for mathematics, US Falls in World Education Rated Average, Huffington Post, July 12, 2010.

Michael Jackson’s message from the grave

by Charlene Smith (c)

It was an accident, just a stupid accident, but when sparks from a fireworks display set fire to 25-year-old Michael Jackson’s hair in 1984, each carried a message about what would cause his death exactly 25 years later.

Only eight years before, then Merck chief executive officer Henry Gadsen was famously quoted in a 1976 Fortune article as saying: “I want to sell drugs to everyone. I want to sell drugs to healthy people. I want drugs to sell like chewing gum.”

Gadsen died in 1980, but by then his dream was coming true. Around the time that he made his statement, some scientists at Sloan Kettering cancer research centre were suggesting opioid painkillers might be effective for more than just terminal cancer pain. This saw a rapid escalation in doctors and dentists prescribing opioids for problems as insignificant as a pulled tooth or stubbed toe.

And another bonus came along for pharmaceutical industries that had quietly paved the way for it. In the year Gadsen died the American Psychiatrists Association, which had long been plagued by controversy around the lack of science to back diagnoses fought back, not with science but with public relations and huge drug company grants.

They came out with DSM-III – the third edition of the Diagnostic and Statistical Manual - which enumerates psychiatric disorders. This manual saw these disorders leap from 182 disorders in 1968 to 265 by 1980. At the time homosexuality was labeled as a ‘sexual orientation disturbance’ but in 1980, while continuing to see homosexuality as a disorder, DSM labeled it as ‘ego-dystonic homosexuality.’ It would take another seven years for homosexuality to be removed as a disorder along with premenstrual dysphoric disorder (the perfectly normal premenstrual tension women experience each month – this has recently again become a disorder by those who seek to create pills and profit from the normal) and masochistic personality disorder became totally normal.

Today psychiatry would have us believe that shyness is a disorder, so is grief, they say, and too those who jiggle their legs when impatient are not quite normal.  In the award-winning Broadway play, Next to Normal, Diana Goodman is pushed into 16 years of prescription drug addiction after the death of her eight-month-old son. In the play she recounts how a psychiatrist told her that any grief that lasts longer than four months is a disorder.

2.4 million schizophrenics in the U.S.

In his award-winning book Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs and the Astonishing Rise of Mental Illness in America, Robert Whitaker tells us that “Drug-induced chronicity has contributed to the rise in the number of disabled mentally ill. In 1955, there were 267,000 people with schizophrenia in state and county mental hospitals, or one in every 617 Americans. Today, there are an estimated 2.4 million people … ill with schizophrenia (or some other psychotic disorder), a disability rate of one in every 125 Americans.” Can it be true that so many people in the most prosperous nation on earth are so seriously disabled, and if so, why?

But let’s get back to Michael Jackson and his accident in 1984, it was the year that the Guinness Book of Records said that his new album, Thriller, was the top-selling album of all time. Jackson’s accident was the sort that has seen millions just like him become addicted to prescription drugs either because their doctors were ignorant of the side-effects of the drugs, or because some pharmaceutical companies and doctors knowingly trapped patients into a process they knew would lead to addiction and high profits. 

A badly burned Jackson began the first of a series of surgeries to correct the burns damage, and along the way threw in cosmetic surgery too. He was put onto painkillers to help reduce the pain from the burns and the surgeries, and so began an addictive spiral, aided by greedy doctors.

While researching prescription drug addiction in West Virginia, one of the poorest states in the U.S.A., I learned of a woman doctor who had lines of patients waiting outside her doors. She would practice until 3a.m. dispensing opioid painkillers by the thousands, and by the time the Drug Enforcement Administration got onto her tail; she jetted off to the island she had bought in the Caribbean.  Recently, as another example, 71-year-old Dr. Tyron Reece of Los Angeles was arrested because he wrote prescriptions in 2010 for some 920,000 hydrocodone pills [Vicodin or Lortab], and according to arresting officers was allegedly involved in smuggling opioids to Mexico (the trade is usually in the opposite direction).

 Dr. Irwin Dhalla of the University of Toronto recently wrote that: “The risk of addiction for patients who are being treated for chronic pain for several months or longer is 35 percent… Addiction is a much bigger problem than physicians think it is." 

Indeed, Dr. David Kloth, a leading member of the American Society of Interventional Pain Physicians told me in an interview for my upcoming book, America the Overmedicated, that 80 percent to 90 percent of those administering pain medications, including physicians, lacked appropriate qualifications.  Experts in the federal administration agree. That is a frightening realization especially when you realize that the top-selling drug, by far, in the United States is hydrocodone, the parent of Vicodin and similar drugs.

Ironically, however, opioid painkillers are easy to get off, you can stop them immediately and although you will go through withdrawal hell of stomach cramps, vomiting and three days to a week of feeling seriously ill, it is not as dangerous as psychiatric drugs which you cannot stop suddenly without endangering your life.

Addiction and profit

Between 1952 when DSM first came out to 2000 the number of psychiatric disorders soared 200%, and continue to increase in line with pharmaceutical company profits which have increased six times globally since 1999. That was also the year that the Federal Drug Administration allowed prescription drug advertising on television and radio, something only New Zealand also allows.  And in those eleven years since prescription drug advertising was allowed on television and radio stations addiction rates have soared in the United States. In April, the White House called prescription drug addiction an “epidemic” but ironically, it is not an epidemic it is marshaling significant resources to combat.

The morning fix - methadone before work

By Charlene Smith
Huntington, West Virginia – It’s 4am and cars snake around three blocks. People stand outside their vehicles chatting. If it wasn’t for the hour you would think they were waiting to get into a sports stadium, instead it’s a methadone clinic, they’re getting their fix before getting the kids ready for school and going to work.
Seventy percent of those standing outside the Huntington Treatment Center, a private methadone clinic, are employed, they are all white. They pay $12 a day for a hit of methadone or suboxone, supposedly to wean themselves off opioid painkillers. For the man in the new SUV next to me, it’s a way to get an added high. He smoothes a piece of paper before sprinkling a crushed pill onto it, probably Oxycontin, the opioid painkiller which is the drug of choice for most, and inhaling.

At $80 for the average 80mg Oxycontin, you can’t be poor, you need to have a good job and the medical insurance with it or receive Medicaid (the US’s crumbling national health insurer).

Three miles away, Professor Ahmet Ozturk, a clinical professor at the Marshall University School of Medicine agrees with the assessment of a nurse at the clinic that methadone or suboxone is little more than “a bandaid.”
Edith Urner, supervisor of the Chemical Dependency Recovery Center at Huntington Memorial Hospital across the country in wealthy Pasadena, California is more cutting: “It’s easier to go through four to seven days of withdrawal from heroin than the absolute hell of three weeks to get off methadone or subaxone so-called treatment. They are potent and long acting.” But Urner says, not enough doctors know enough about helping addicts. “It’s not dangerous to stop opioids abruptly, but it is dangerous to try the same with benzodiazepans (eg Valium) or barbiturates.”

And while there are many out-patient clinics, an inpatient facility like the CDRC in Pasadena costs $1 000 a day, average treatment needed? Ten days for opioid addiction. In that time they start a process of teaching patients non-drug alternatives.

The two hospitals, one in a wealthy area, and the other in an economically depressed zone have nothing in common but for the challenge of dealing with what the White House in April called “an epidemic” of prescription drug abuse.
This epidemic, Ozturk, Urner and others agree is making all other drug addiction scenarios look like childs play. Already 27,000 Americans are dying every year because of prescription drug overdoses – in Florida where pill-mills are common, there are seven overdose deaths a day and around 20 percent of babies are born addicted.

Prescription drug addiction in the USA is so extensive it has all but killed the cocaine trade and has ousted marijuana as the gateway drug for teens. The National Survey on Drug Use and Health reported in 2010, “a marked decrease in the use of some illegal drugs like cocaine.” The quantity of cocaine seized in El Salvador and destined for the United States plummeted for the second consecutive year, from 4,074 kg in 2007 to 394 kg in 2009, according to the International Narcotics Control Board.

The INCB expressed concern about the rapid increase in prescription drug abuse in the U.S.A. and observed that in 2009, 4.8 million Americans used cocaine compared to 12.4 million Americans who abused prescription pain relievers. The number of emergency room visits involving legal drugs more than doubled from 2004 to 2008, mainly as a result of the abuse of hydrocodone, methadone and oxycodone.

But its good for job creation around this legal drug trade. Around the Huntington Treatment Center are two pawn shops, a 24-hour MacDonald’s, a large Walgreens drive-thru pharmacy and loads of free parking. This Treatment Center, one of a few in this small town that borders Ohio and Michigan, sees an average of 700 patients a day while its parent company, CRC Health Group, has 150 clinics that sees 30,000 nationwide. National spokesperson Kristen Hayes, rejected an interview request and slammed the phone down when questions were asked.
Dr Ozturk shrugs, “CRC don’t take referrals from physcians and they won’t tell us if a patient is on methadone… If they don’t tell us we cannot co-ordinate treatment. Section 42CRF under federal law the Addiction Act says that patient history or current treatment is strictly protected, but the law also says that when medically necessary patient information should be released. They won’t it give to us but then again everyone is afraid of getting sued… “
There is little doubt that the primary dealers are doctors, yet when they are arrested, often after multiple overdoses among patients, their jail terms are low, most often they will get a $15 000 fine and a suspended sentence.

Most doctors overprescribe because of ignorance. Dr David Kloth of the American Society of Interventional Pain Physicians says a lack of training in pain management at medical schools is to blame.

For example, “most spinal surgeons have no formal training in pain management, nor do radiologists. Of those who are extremely qualified and certified to do intervention pain management, there are maybe only 7 000 to 8 000 across the USA.
“There are a lot of doctors prescribing medications that do not have proper expertise, I am not trying to put the doctors down, but these are highly addictive substances that interact with other medications.”
The world prescription drug market was worth $856 billion in 2010 – it has almost doubled in value in a decade. In the United States prescription drugs netted a cool $307.4 billion for pharmaceutical companies in 2010 ($270.3 billion in 2006). By far the biggest seller is hydrocodone/acetaminophen, a Schedule Three painkiller and cough syrup. It netted $131.2 million in legal sales in 2010.
Hydrocodone is a semi-synthetic opioid derived from codeine and thebaine and is often compounded with paracetamol or ibuprofen. Codeine and cough syrups are routinely abused in South Africa and the INCB has expressed concern that “In Africa, the illicit manufacture of psychotropic substances for local abuse takes place mainly in South Africa…The illicitly manufactured drugs are predominantly methamphetamine, methcathinone and methaqualone (Mandrax). The precursor chemicals … are usually imported into South Africa legally but then diverted from domestic distribution channels.”
Prof Charles Parry, director of the Alcohol & Drug Abuse Research Unit at the South African Medical Research Council says prescription drug abuse in South Africa is “absolutely” a problem. “And one that is somewhat hidden. The prime prescription drugs of abuse are benzodiazepines (e.g. Valium, Ativan, Alzam), analgesics (containing codeine – though many can be bought without prescription) and stimulant drugs such as Ritalin (methylphenidate) used to treat ADHD. Among physicians, abuse of pethidine (an analgesic) has been an issue in the past.”
Whereas the profile of those most addicted in the USA is white educated, working men aged 30 to 60, “In South Africa women feature more heavily than men in the abuse of over-the-counter (OTC) and prescription drugs… and middle and upper classes are more likely to abuse prescription medicines. A recent study in Cape Town found that abusers of OTCs and prescription medicines were primarily from the White population followed by Coloureds and Indians.
“A lot depends on what steps are taken to address the potential for the abuse of products , for example, real time prescription registers that prevent people filling scripts fraudulently across multiple pharmacies (this is starting to happen now with pharmacies that are linked, like the Clicks network, but we need to link pharmacies together that are not in the same networks). We also need to work with medical aid companies to look into why certain clients remain on benzodiazepines for long periods of time following an acute incident. Doctors need to prescribe where needed but to be mindful of the abuse potential when giving repeat scripts.”

And that is in part, where some of the problem lies, it can be so profitable for a doctor to have addicted clients.

The US Drug Enforcement Administration says that, “Hydrocodone is the most frequently prescribed opiate in the United States with more than 139 million prescriptions for hydrocodone-containing products dispensed in 2010 and more than 36 million in the first quarter of 2011.” In Oklahoma, as an example, where the number of deaths annually due to accidental overdose of prescription drugs has nearly tripled in the past decade, according to Oklahoma Medical Examiner’s office, hydrocodone is most often involved, followed by the anti-anxiety drug alprazolam, and two other painkillers: oxycodone and morphine.
The US has adopted drug-takeback days and launched a variety of initiatives, not one of which yet, does anything meaningful to address an epidemic that cuts to the heart of its working population at a time of economic crisis.

What Congress can do to save billions (and thousands of lives) fast: ban prescription drug advertising to consumers

By Charlene Smith
There is a quick way Congress can save billions of dollars and thousands of American lives: ban direct to consumer prescription drug advertising. In 1999, the Food and Drug Administration allowed the broadcast of direct-to-consumer prescription drug advertisements.
The United States became the only country in the world to do this aside from tiny New Zealand. In April, the White House, referring to an “epidemic” of prescription drug abuse told us that, “from 1997 to 2007, the milligram per person use of prescription opioids in the U.S. increased from 74 milligrams to 369 milligrams, an increase of 402 percent… In 2000, retail pharmacies dispensed 174 million prescriptions for opioids; by 2009, 257 million prescriptions were dispensed, an increase of 48 percent.”
Note the correlation in the commencement of broadcast ads about these drugs to the upswing in use and abuse. Today the United States with just four percent of the world’s population consumes almost half its prescription drugs. Our children pop two-thirds of the world’s supply of Ritalin. And 80 percent of the world’s opioid painkillers are consumed here, according to IMS Health.

A recent Centers for Disease Control report notes that by 2005 (when the epidemic was still in its early stages) opioid abuse was costing the U.S. more than $8.6 billion a year, and $9.5 billion in lost productivity. The death toll is around 37, 000 Americans a year and is second only to traffic accidents.

Prescription drug abuse is almost entirely an epidemic of the educated, employed white middle-classes – usually educated males aged 30 to 60.
Opioid painkillers are now so extensively abused that teenagers are more likely to experiment with the drugs in mom and dad’s medicine cabinet than to try marijuana. The National Survey on Drug Use and Health reported in 2010, “a marked decrease in the use of some illegal drugs like cocaine.” The quantity of cocaine seized in El Salvador and destined for the United States plummeted for the second consecutive year, from 4,074 kg in 2007 to 394 kg in 2009, according to the International Narcotics Control Board.
In the United States pharmaceutical companies earned $307.4 billion in 2010 ($270.3 billion in 2006) and by far the biggest seller was hydrocodone/acetaminophen or Vicodin, a Schedule Three painkiller and cough syrup. It netted $131.2 million in legal sales in 2010. The Drug Enforcement Administration says: “Hydrocodone [Vicodin] is the most frequently prescribed opiate in the United States with more than 139 million prescriptions for hydrocodone-containing products dispensed in 2010 and more than 36 million in the first quarter of 2011.”

In Oklahoma, Montana and Arkansas, the CDC says the number of deaths annually due to accidental overdose of prescription drugs has nearly tripled in the past decade, West Virginia has seen a 500 percent increase.

The Oklahoma Medical Examiner’s office says hydrocodone is most often involved, followed by the anti-anxiety drug alprazolam, and two other painkillers: oxycodone and morphine.
Accidental overdoses from Vicodin and other pain relievers kill more people than car accidents in 17 states, according to Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention. Public health and law enforcement officials said in a recent press conference that painkillers are now responsible for more deaths than crack in the 1980s and black tar heroin in the 1970s combined.
Jerry Avorn, an internist and professor of medicine at Harvard and the author of Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs, has observed: “Every other industrialized nation has figured out how to provide health care to all their citizens and how to get drug makers to negotiate the prices of their products, each of those countries (except New Zealand) also bans direct-to-consumer advertising for prescription drugs… All those other countries have it right, and we don’t. Doctors spend precious minutes of ever-shorter office visits explaining to patients why their cholesterol drug is every bit as good as the one they saw on television, or why feeling sad at the death of a loved one doesn’t require an antidepressant. Hawking medications to the public encourages rapid adoption of new products that may be no better — or even worse — than older, unadvertised generic drugs.”
The FDA threw a bonanza of wealth to drug companies and a burden for consumers. A May 2011, issue summary from the Congressional Budget Office noted that, “the average number of prescriptions written for newly approved brand-name drugs with DTC advertising was nine times greater than the average number of prescriptions written for newly approved brand-name drugs without DTC advertising.” The Kaiser Family Foundation reported in May 2010, that “manufacturer spending on advertising was over 1.5 times as much in 2009 ($10.9 billion) as in 1999 ($6.6 billion). “
The American Journal of Medicine has called for the federal government to “control the prices of prescription drugs as is done in nearly every other nation. Drug companies can charge whatever they wish in the U.S.

Citizens of other nations pay 20 percent to 40 percent less for prescription drugs compared with what Americans pay…

Some authorities have suggested that if we decrease the profits of drug companies they will stop developing new drugs. Given that drug companies spend more than twice as much for marketing and advertising as they do for research this is a very unlikely outcome.”
Former Merck Executive, Peter De Vilbiss agrees. He told Forbes magazine writer, Matthew Herper: “It is hard to make a case that a pharma company is R&D driven when a quick look at the income statement reveals that more money is spent on marketing and advertising than it is on R&D…. For one pharma to voluntarily ramp down it’s M&A spend significantly would be suicide…
“If there was a regulatory mandate for all pharma companies to cease direct-to-consumer advertising for prescription drugs and vaccines… bottom line profits could actually increase, providing more money for R&D and allowing companies to focus more time and energy on portfolio management of drug pipelines… the industry image and reputation may improve. It seems as if a lot of bad publicity arrived on the pharma scene as a result of all the DTC ads.”
Pharma, buoyed by its successes with broadcast has now turned its attention to online ads. Research firm eMarketer expects spending on online advertising to grow to $1.86 billion by 2015, up from $1.03 billion last year. For 2011, healthcare and pharma will boost web spending by 13 percent, to $1.17 billion. The danger with this was alluded to by The American Journal of Medicine: the U.S. has the highest prices in the world for prescription drugs which has led to a multi-million dollar cross border trade by citizens with Canada and Mexico. It has also fueled internet buying. As one such site observes: “Buying Celebrex at a Mexican pharmacy could be approximately 483% cheaper than the same drug bought at an American pharmacy.” The sites look authentic, most have lots of photographs of doctors and nurses, but few demand prescriptions and delivery is by a conventional courier within 24 hours. Legal and illicit sales become harder to discern and much harder for law enforcement officials to police.

In his lone dissent from the 1976 Supreme Court case that enabled drug companies to advertise, Justice William Rehnquist observed that “the societal interest against the promotion of drug use for every ill, real and imaginary, seems to me exceptionally strong.”

But it seems that while pharmaceutical companies remain the most powerful in the U.S. with the most prosperous lobbyists on Capitol Hill (they spent more than $250 million in 2009); fighting prescription drug advertising will be as hard as the war on tobacco advertising – and as necessary as addiction and deaths mount.