When Lawsuits Aren’t Enough: Big Pharma and the Opioid Epidemic

Guest Post by Morgan Statt

Hardly a day goes by without hearing news of America’s opioid epidemic. 2016 was the worst year for opioid deaths, with overdoses claiming over 63,000 lives. With jarring statistics like this one, government officials have started to assign blame for opioid use reaching crisis levels.

Their target? Drug companies

Almost every single state in the U.S. has filed lawsuits against drug manufacturers and distributors for their involvement and essential creation of the opioid epidemic. Sadly the cost penalties, which are minuscule in the face of humongous profits, are unlikely to trigger genuine reform.

Big Pharma is Big Business.

We can assign blame to the drug companies for their involvement in the crisis, and lawsuits are an effective way to do that. However if we are genuine about stemming the current opioid crisis, we must commit to making fundamental changes in the US health care system.

Two areas in vital need of reform are clinical trial funding and massive Big Pharma lobbying.

  1. Drug companies are allowed to fund clinical trials

Each year, the National Institute of Health sets aside a portion of its budget to fund clinical trials that are needed before a drug can hit the market. In recent years, however, a Johns Hopkins study revealed that this funding has drastically fallen and is now largely supported by pharmaceutical companies. With financial interest in the outcomes of certain clinical trials, industry funding presents the opportunity for drug companies to favor positive results over negative outcomes that may affect patient safety.

Look no further than the blood thinner Pradaxa’s clinical trial RE-LY to serve as an example. Critics of this industry-funded trial pointed out that it generalized the medication’s population and failed to be a double-blind study, presenting a prime possibility for bias and misreporting.

Hasty FDA approval followed these skewed trial results, and Pradaxa was put on the market in 2010 without an antidote to reduce its blood thinning effects. For five years, an antidote failed to be introduced, and severe bleeding incidents and over 1,000 deaths occurred as a result of taking the medication. Since then, a wave of lawsuits have been filed against manufacturer Boehringer Ingelheim for its hand in the bleeding incidents. Finally in 2014, over 4,000 claims were satisfied with a $650 million settlement.

  1. The #1 Lobbying Industry is Pharmaceutical/Health

Lobbying is a legal activity that is meant to help those who don’t have direct access to members of Congress get their voices heard. Although this practice is theoretically good-hearted, the reality is that money has the power to influence decisions that negatively impact the American public. In the first quarter of 2017 alone, the pharmaceutical industry spent $78 million in its lobbying efforts, an increase of $10 million since 2016.

This phenomenal dollar spend has enabled Big Pharma to sway policy decisions in favor of big business rather than public safety. In regards to the opioid crisis, The Pain Care Forum, funded by the pharmaceutical industry, spent over $740 million to stop legislation that would have put limits on opioid prescribing habits.


Morgan Statt is a Safety Investigator at ConsumerSafety.org

 

photo credit: DES Daughter Opioid Epidemic via photopin (license)

Pill Pushers in Suits: The Addition Potential of Psychotropic Medication

 

Overpill: The Darker Side of America’s Mental Health

RT (2017)

Film Review

Overpill is a documentary based on the investigation of a Russian-born accountant into the massive overprescription of psychotropic drugs (medications for depression, schizophrenia, bipolar disorder and ADHD) in the US. He became aware of the issue while working for Health Care Communications, a company that markets prescription drugs to Americans for ordinary problems of living. He undertook this investigation after becoming romantically involved with a woman who was addicted to antidepressants and antispsychotics while, despite experiencing horrendous side effects.

The film features extended interviews with former patients who got their lives back after the excruciating ordeal of weaning themselves off medication, with others still struggling with side effects while weaning themselves off, with a malpractice attorney who represents patients experiencing permanent and painful psychotropic complications and Dr Peter Breggin, a controversial American psychiatrist and outspoken critic of the overuse of psychotropic medication.

Both men are alarmed by the deliberate effort by pharmaceutical companies to conceal the addictive potential of antidepressants and antipsychotics, as well as studies showing these drugs can permanently alter the submicroscopic architecture of the brain. This is of special concern with the growing number of psychotropics prescribed in children with developing brains. There are virtually no studies of the long term effect of these drugs in either adults or children.

While the film acknowledges that psychotropic medication can be literally life-saving in some patients with severe mental illness, it rightly points out there are far too many cases in which they’re being inappropriately prescribed.

As a class psychotropic drugs (which are heavily marketed to consumers), are the third most profitable for the pharmaceutical industry.

 

The Hidden History of Smallpox Vaccine

Suzanne Humphries – Dissolving Illusions

Dr Suzanne Humphries (2017)

In this video, board certified nephrologist Suzanne Humphries explodes the myth that mass vaccination was responsible for eradicating small pox in the developed world.

She begins by describing the vaccine’s development by Edward Jenner in the 18th century. Jenner’s decision to inject children with pus from cows infected with cowpox was based on his theory, which has never been proven, that it would protect them from developing smallpox.

A close examination of the medical literature reveals Jenner’s vaccine was never effective against the most virulent form of smallpox. In England an 1871 outbreak of smallpox, after 33 years of compulsory vaccination (leading to unprecedented levels of sickness and death in healthy children), would lead to first anti-vaccine movement by outraged parents. By 1889 when they finally overturned compulsory vaccination, only 15% of parents were complying with the law – they preferred risking imprisonment and seizure of their property to jeopardizing their children’s lives.

Humphries goes on to discuss more recent smallpox outbreaks in vaccinated populations – in 1945 in 100% vaccinated US troops and in 1972 in Yugoslavia, where over 95% were vaccinated.

Most interesting, however, is her description of George W Bush’s abortive attempt to mass vaccinate Americans in 2003. This initiative was based on alleged intelligence that “terrorists” were planning to attack the US with weaponized smallpox virus.

The project was scrapped after the CDC ruled that patients would have to give informed consent acknowledging the vaccine was more likely to kill them than small pox (the CDC predicted 285 deaths in otherwise healthy individuals). The required package insert revealed that small pox vaccine is contraindicated in patients under 18 and those with a personal or family history of heart disease, diabetes or elevated cholesterol.

Humphries maintains that smallpox vanished from the developed world (in 1979) for the same reason as other infectious illnesses, such as typhoid, scarlet fever and cholera. The infectious epidemics that scourged 18th and 19th century slums were largely the product of contaminated drinking water, near-starvation diets, overcrowding and poor hygiene. As smallpox virus is only transmitted through direct physical contact, most 19th century cases were transmitted by doctors, nurses and carers who failed to wash their hands.

At the end of her talk, Humphries compares doctor’s superstitious attitudes towards non-evidence based vaccinations to blood letting, another common medical treatment in the 19th century. Owing to the power of Big Pharma and the failure of medical schools to expose students to the extensive  medical literature about vaccination drawbacks, doctors (like Humphries) who raise legitimate concerns about vaccine safety continue to be treated like criminals and quacks.

Anatomy of Modern Corruption: The Clinton Foundation and the Superdelegates

What Hillary Clinton Really Represents

Empire Files (2016)

Film Review

This early 2016 documentary is a virtual encyclopedia of Clinton family corruption. Based entirely on publicly verifiable information, it reveals how Hillary, especially, has based her political career on supporting legislation that specifically benefits her corporate and foreign donors. It also explores the identity of some of the 700 Democratic “superdelegates” who helped deny Bernie Sanders the Democratic nomination – despite overwhelming support he received from voters.

The Clinton Foundation was founded in 1997 with the alleged purpose of providing humanitarian relief after international disasters. Its real purpose, however, was to engage in “crisis capitalism,” a term coined by Naomi Klein in The Shock Doctrine. Following a disasters, such as the 2001 earthquake in India, the Clinton Foundation would waltz in and create a variety of for-profit projects enabling further exploitation of third world resources and labor by Clinton Foundation donors.

Major donors to the Clinton foundation included Exxon, Walmart, Pfizer, Dow, Monsanto, General Electric (GE), Fox News, the Soros Foundation, Freddie Mac and Fannie Mae. As senator, Clinton rewarded the latter two donors by supporting deregulation that would lead to their bankruptcy in 2008 and a massive taxpayer bailout.

As Secretary of State, Clinton would grant similar favors to Boeing and GE by facilitating overseas sales of their military hardware and to Exxon by heavily promoting the spread of fracking throughout the world.

Countries such as Saudi Arabia, Oman, United Arab Republic and Qatar were also big donors to the Clinton Foundation. In all 181 Clinton Foundation donors lobbied Clinton as Secretary of State and most were successful in getting the policies they advocated enacted.

Many of the 700 superdelegates appointed by the Democratic National Committee (to help ensure their hand picked candidates won the Democratic primary) were also corporate lobbyists hoping to benefit financially from a Clinton presidency: among others, the corporate lobbies represented included the Excel pipeline, the private prison industry, Big Pharma and the four main Wall Street banks (City Group, Morgan Stanley, Goldman Sachs and JP Morgan Chase).

How Big Pharma Controls Health Care

big_pharma

Big Pharma: How the World’s Biggest Drug Companies Control Illness

By Jacky Law

Constable and Robinson Ltd (2006)

Book Review

In the ten years since British journalist Jacky Law published Big Pharma, the only good news is growing public awareness of the drug industry’s negative effect on human health. There’s no question the wealth and power of the pharmaceutical industry has vastly increased with the enactment of Obamacare in 2010. The latter grants major federal subsidies to both the insurance and drug industry.

Law carefully unpacks the fundamentals that position Big Pharma’s profits at the very top of Fortune 500 companies. In 2001, for example, they were number one, earning profits equal to 16-18% of sales. The banking industry was a distance second at 13.5%. While other Fortune 500 companies averaged 3.3%.

She attributes these obscene profits mainly to inflated prices Big Pharma charges Americans (as much as 5-10 times as much as in other countries), their deliberate efforts to bury and/or spin negative research, their bribing of doctors (with gifts, free lunch, training junkets and consultant fees) and medical journals (with glossy high priced ads), the refusal of the FDA to regulate pharmaceuticals (see FDA Now Completely Sold Out to Big Pharma) and direct to consumer ads aimed at convincing healthy people they need medical attention.

She devotes a whole chapter to “disease mongering,” Big Pharma’s deliberate creation of fictitious illnesses such as menopause, serotonin deficiency, post luteal dysphoric disorder and female sexual desire disorder. This is a topic I blog about frequently. See The Multibillion Dollar Depression Industry, Drug Companies: Killing Kids for Profit, Wyeth and the Multimillion Dollar Menopause Industry and Menopause Made in the USA

She also details studies dating back to 1982 revealing that low fat diets don’t decrease cardiovascular disease, as well as studies from 1992 revealing that cholesterol lowering drugs (statins) don’t reduce mortality. Thanks to the deliberate harassment and demonization of the researchers responsible for these studies, this information has only come into public view in the last two years. See Why the Low Fat Diet Makes You Fat (and Gives You Heart Disease, Cancer and Tooth Decay

Law is also highly critical of the role the pharmaceutical industry has played in minimizing the importance of poor nutrition and exposure to toxic chemicals in causing illness. She finds it extremely ironic (and immoral) that the federal government is clamping down on health supplements instead of environmental toxins.

The Drug Shortage Scandal

pills

This morning I was intrigued to learn that the US has been experiencing regular shortages of anesthetics, painkillers, antibiotics, cancer treatments, heart drugs and other lifesaving medications. Doctors routinely deal with these shortages by “rationing.” In other words, deciding which patients are more deserving of treatment.

Although the problem has been going on a decade or more, most doctors don’t inform patients when they withhold clinically indicated treatments. Prior to a January 29 New York Times article Drug shortages forcing hard decisions on rationing treatment, the American public was also totally in the dark.

Did you know there was a Drug Shortages Summit in 2011 to address this public health emergency? I sure didn’t. Nor did I know know about the Food and Drug Administration Safety and Innovation Act (FDASIA) Congress passed four years ago to address the crisis.

The FDA Solution: A New App

A recent examination of the FDA website, which lists nearly 100 current drug shortages, suggests FDASIA isn’t working that well. However taxpayers will be pleased to learn the FDA has created a new app for android devices that sends alerts when the Agency adds or updates shortage information. They are currently working on an iOS version, which will be available soon.

The New York Times article profiles several doctors who talk about the difficulty of deciding which patients are more worthy of treatment. Some institutions have formal committees that include ethicists and patient representatives to decide which patients receive a needed drug — and which do not.

A February 8 Times editorial waffles about the “root cause” of the drug shortage crisis. Their list of possible causes includes “manufacturing quality and compliance problems, raw material sourcing, and drug company consolidation and business decisions that result in the discontinuation of critical drugs.”

M.E. Markowski is far more direct in a 2012 Harvard Law School paper The Problem of Inadequate Profits. Markowski states, in essence, that pharmaceutical companies have no profit incentive to create a sufficient supply of essential medications to meet patient need.

Unbelievable. The US spends twice as much (per capita) as any other country. Drug company profits are soaring. Meanwhile patients are dying because they can’t get medications they need for life threatening conditions.

The Solution is Easy

Although the OECD ranks New Zealand far below the US in economic standing (20th as opposed to 4th), we don’t suffer from major drug shortages here. Like all other industrial countries (except for the US), we have a national health service. In this country, drug availability isn’t determined by drug companies seeking to increase their profits. In New Zealand Pharmac, a government agency staffed by health professionals, makes all our drug purchasing decisions.

Photo credit: J. Troha (Photographer) [Public domain or Public domain], via Wikimedia Commons

The Cancer Conspiracy

Cancer: the Forbidden Cures

Messimo Mazzucco (2010)

Film Review

Cancer: the Forbidden Cures examines the deliberate effort, by the medical establishment and Big Pharma, to suppress non-phamaceutical cancer treatments. According to filmmaker Messimo Mazzucco, this is the main reason there have been no innovations in cancer treatment in the last hundred years.

Treating cancer is a big business, worth more than $50 million a year – despite the extremely poor track record of conventional cancer treatment. Both radiation therapy and chemotherapy are carcinogenic (i.e. cause cancer). Moreover because both shut down the immune system, it’s common, particularly with chemotherapy, for the treatment to kill the patient before the cancer does. According to Mazzucco, at most 5% of patients “cure” their cancer with chemotherapy.

The documentary begins by tracing how Rockefeller, Carnegie and J. P. Morgan, as barons of the chemical industry (which would morph into the pharmaceutical industry) facilitated the corporate takeover of modern medicine. Prior to 1900, American doctors mainly relied on natural healing methods involving diet and herbs, as many Asian countries still do today. All this changed after World War I when the chemical barons used their wealth and influence to win seats on the boards of major medical schools, as well as taking over the American Medical Association (AMA) and the Bureau of Chemistry (which became the Food and Drug Administration in 1927).

By the 1930s, the AMA had achieved a monopoly on medical licensing in all forty-eight states. This meant that only AMA-approved doctors, trained exclusively in drug treatments, could legally practice medicine. By 1990, the pharmaceutical industry also controlled most medical research. This was thanks to systematic cutbacks in National Institutes of Health (NIH) research that began in 1980 under Reagan administration.

The remainder of the film is a celebration of cancer pioneers who have put their livelihoods, careers and often their lives on the line to offer (often at no charge) alternative cancer treatments. Over the last hundred years, dozens of “natural” cancer treatments have successfully treated hundreds of thousands of patients.  Mazzucco believes if these treatments were widely available, cancer mortality could be reduced by 50%.*

Of the treatments listed below, laetrile and bicarbonate are the most controversial, as both have a very narrow margin between the therapeutic and toxic dose. They should only be used under professional supervision.

Essaic – first developed by Canadian nurse Rene Caisse (1988-1978) in the 1920s based on herbal treatments she learned from the local Ojibwe tribe. In the 1930s the county council allotted her a free clinic on condition that her patients were diagnosed by a licensed doctors and treated free of charge. After successfully treating thousands of patients, she lost the clinic when she refused to sell her treatment by to a group of American “entrepreneurs” for one million dollars.** In 1958, Senator John Kennedy’s doctor Charles Brush referred Essiac to Sloan Kettering Cancer Research Center to be evaluated for FDA. The research never happened.

Hoxsey therapy – Texas businessman Harry Hoxsey (1901-1974) was the first to treat human beings with an herbal remedy his great-grandfather had used successfully to treat cancer in horses. Hoxsey set up clinics offering free cancer treatment in seventeen states for nearly twenty-five years. Thanks to his phenomenal success rate, he somehow eluded all attempts to prosecute him (for practicing medicine without a license). One prosecutor who had arrested him a hundred times secretly brought his brother in treatment and (following the brother’s recovery) became Hoxsey’s defense lawyer. When Hoxsey request an FDA review of his treatment (for possible approval), the head of the AMA, Dr Morris Fishbein offered to buy the rights to Hoxsey’s formula. When Hoxsey refused, Fishbein spearingheaded a nationwide media campaign depicting Hoxsey as a dangerous quack. After Hoxsey successfully sued both Fishbein and the Hearst newspaper empire for libel, the FDA padlocked all his clinics. In 1963, he helped one of his nurses set up a Hoxsey clinic in Tijuana Mexico.

Gerson therapy – Dr Max Gerson (1881-1959) believed his nutrition-based cancer treatment, consisting of a non-meat diet of raw and cooked vegetables and juices, improved immune function by reducing the “acidity” associate with a meat diet. In 1946, and five patients he had cured testified before Congress in support of the Pepper-Neely Anti-Cancer Bill. The latter would have appropriated one hundred million dollars to research novel cancer treatments. After being banned from practicing or publishing in the US, he published his research in German medical journals and saw patients privately in his apartment. Following his death, his daughter Charlotte set up a Gerson clinic in Mexico. His followers have also established Gerson clinics in Germany, Spain and Japan. See Rethinking Cancer Treatment

• Shark Cartilage – In the early nineties Dr William Lane pioneered the use of shark cartilage in treating cancer owing to its antiangenic properties (i.e. it suffocates the cancer by blocking the formation of blood vessels to supply it). Despite efforts by FDA and American Cancer Society to discredit the treatment, pharmaceutical companies are vigorously competing with one another to isolate the specific therapeutic agent in the lab.

• Mistletoe – First proposed by Rudolph Steiner (1861-1925) as a cancer treatment, owing to its immune modulating properties, 100 years ago. Enormously popular in Europe, where Druids worshiped it for its miraculous healing properties. Although mistletoe doesn’t occur naturally in the US, it’s currently being studied as a cancer treatment at John Hopkins Medical School.

• Laetrile (aka Vitamin B17) – Laetrile, derived from apricot and peach pits, was first proposed as a cancer remedy in the late 1800s. Dr Ernest Krebs Jr first brought it to public attention in the 1970s. Practitioners who have prescribed it have found it effective in treating breast, lung, collar and prostate cancer. It’s believed to work by releasing cyanide and benzaldehyde when it comes in contact with cancer cells. The FDA banned it in 1977 after it was linked with several cases of cyanide poisoning.

• Sodium bicarbonate – first developed as a cancer treatment by conventionally trained Italian doctor and oncologist Tullio Simoncini. Simoncini believes cancer is merely the body’s reaction to an internal candida infection. He believes bicarb works by suppressing the infection, as the fungus only thrives in an acid environment. Because large oral doses of bicarb can be very dangerous, Simoncini infuses it through a catheter to blood vessels adjacent to the tumor. In 2003 he was stripped of his medical license and in 2006 he was given a 3 year suspended sentence for fraud and wrongful death after one of his patients die of alkalosis from an overdose of bicarbonate.


*This 2010 documentary predates a flood of research about the anti-cancer effect of high cannabidiol (high CBD) cannabis.
**They refused to agree to Caisse’s condition that they offer Essiac to patients the treatment free of charge.

My New Expatriate Identity

exceptionalism

(the 2nd of 8 posts about my new life in New Zealand)

For people over fifty, starting over in a new country is like dropping a lab rat in a gigantic maze. Like the rat, you suddenly find yourself in an alien environment that constantly confronts you with new decision points and obstacles.

For example, learning to use a new phone system. It took me months to figure out the Christchurch phone book, owing to the unique alphabetization protocol New Zealand uses. I also had to learn to dial 111 for emergencies, 1 for an outside line and 0 for a cellphone or long distance number. And not to waste hours redialing a number when I got a “fast busy” signal. It sounds exactly like the “slow busy” signal but means the number has been disconnected.

It helped a lot to meet other American expatriates struggling with the same problems. It was also extremely gratifying to realize I wasn’t alone in my total repudiation of Bush’s wars crimes in Afghanistan and Iraq.

As I would later learn, tens of thousands of American progressives and liberals left the US during the Bush years. In November 2003, expatriate Americans led the antiwar demonstrations protesting Bush’s visit to London. American expatriates also formed major voting blocks voting blocs for Kerry in 2004 and for Obama in 2008 (I myself didn’t vote for him – I voted for Nader).

My Struggle With American Exceptionalism

Ironically the biggest hurdle I had to overcome was my own lack of objectivity regarding my country of origin. Given that my decision to emigrate was politically motivated, this really surprised me. Somehow it seems no matter how strongly Americans consciously reject America’s immoral and corrupt political system, we all unconsciously buy into the American exceptionalism that the education system and corporate media pound into us. The belief that the US is not only the foremost military and economic power, but also the most productive, efficient, cleanest, healthiest, transparent, just and scientifically advanced.

This is an extremely rude awakening for many Americans. It certainly was for me. In my case, Kiwi colleagues confronted me for my attitude that the US was more advanced in medical research. Looking back, I am both mystified and embarrassed that I took this position. I have known for at least two decades that US medical research is mainly funded by Big Pharma, which has a well-earned reputation for buying and publishing research that promotes profits at the expense of scientific objectivity.

Two of the most common examples are 1) research that promotes fictitious illnesses (such as estrogen “deficiency” disorder in menopausal women) to market marginally effective and frankly harmful drugs and 2) research that grossly minimizes the role preventive medicine and non-pharmaceutical interventions have in promoting and maintaining human health.

The Link Between Exceptionalism and Empire

Over time I came to understand that citizens in all great military empires are under enormous pressure to hold and express patriotic and exceptionalist beliefs. In Nazi Germany, you could be shot on the street for unpatriotic statements. When Britain was the world’s great empire, they gave you a trial first, but you could be imprisoned or even executed for treasonous utterances.

This is the second major awakening for many American expatriates: until we leave, we never fully appreciate that US militarism overshadows all aspects of American life. Again I have known for decades that the US government spends more than half their budget on the Pentagon. I also know that the purpose of the US military isn’t to defend ordinary Americans. The US invades and occupies other countries to guarantee US corporations access to cheap natural resources, sweat shop labor and markets for agricultural exports.

Yet it wasn’t until I left that I fully recognized the enormous personal price Americans pay – in terms of personal liberty, freedom of speech and thought and quality of life – as subjects of a great military empire.

photo credit: mpeake via photopin cc

The Me-Too Drug Ripoff

antipharma

In addition to the billions of health care dollars drug companies waste on disease mongering (see earlier posts), billions more are wasted on developing and marketing hundreds of “me-too” drugs. By definition, a “me-too” or “copycat” drug is a very slight variation of a drug already on the market.

The main downside of me-too drugs that they drive up health care costs  – the exorbitant cost of medical care is the main reason millions of Americans can’t afford a doctor when they’re ill. Other drawbacks of Big Pharma’s fixation with copycat drugs include the neglect of hundreds of potentially treatable illnesses and hundreds of cases of premature death and/or permanent disability related to inadequate safety profiling. Nearly all the major drug recalls in the last few years have involved copycat drugs that were assumed safe because they were chemically similar to medications already on the market.

An Issue First Raised by Ralph Nader

To the best of my recollection, Ralph Nader was the first to raise the issue of “me-too” drugs in his 2000 presidential campaign. Dr Marcia Angell, Harvard Senior Lecturer in Social Medicine, also covers the subject extensively in The Truth About the Drug Companies: How They Deceive Us and What To Do About It (2004) and in “Excess in the pharmaceutical industry” in the Canadian Medical Association Journal

According to Angell, it’s quite common for a drug company to manufacture their own copycat drugs when their patent is about to expire. The idea is to persuade doctors not to opt for cheaper generics when brand named drugs lose their patent protection. She gives the example of AstraZeneca reformulating the ulcer drug Priloxec to bring out Nexium, a nearly identical replacement. The company also shrewdly increased the price of Prilosec to get people to switch.

Three virtually identical cholesterol lowering drugs, Provochol, Zocor and Lipitor were introduced soon after Lipitor (introduced in 2002) became the best selling pharmaceutical in history . The latter was the first statin, a class of drugs that inhibits cholesterol formation in the liver. There are now eight virtually identical statin medications, excluding combination medications that contain it.

Billions Spent on Marketing Identical Drugs

OF all the drugs the FDA approved between 1993 and 2003, 78% were similar to already marketed drugs. Even more shocking, 68% weren’t even new compounds but a reformulation (change from capsule to tablet, short to long acting, etc) or a recombination of existing drugs.

Angell also laments the billions of dollars drug companies spend persuading doctors (and now patients through direct-to-consumer advertising) that their new me-too drug is more effective or safer than the older versions on the market. In most cases, they do this without a shred of scientific evidence. The FDA only requires pre-approval trials to compare me-too drugs to placebo and not to existing medications.

Big Pharma’s View on Me-Too drugs

Pharmaceutical companies want us to believe that me-too drugs enhance health care delivery. They allege that copycat drugs lower prescription costs by increasing competition. They also assert that doctors need a range of back-up drugs when the first-line medication doesn’t work or isn’t tolerated.

The claim about lowering prescription costs is utter rubbish. Copycat drugs are always priced the same or higher than the older drugs they supposedly compete with. And drug companies never, ever market their me-too drugs to doctors or patients on the basis of cost savings. As the price for brand name prescription drugs soars through the roof, only the easy availability of quality generics keeps prescription costs affordable for patients.

To justify the value of providing doctors a range of similar drugs to choose from, drug industry analysts give the example of the numerous copycat SSRIs available for treating depression. In doing so, they claim that some patients who fail to respond to Prozac, may respond to Paxil, Zoloft, Celexa, Priligy, Lexapro, Zelmid, Viibyrd or Upstene.

This is yet another marketing claim unsubstantiated by scientific research. After prescribing SSRIs for 25 years, I, like most of my colleagues, have never found a differential response to different brands. In fact my clinical experience coincides very closely to a recent literature review of SSRI effectiveness. This meta analysis revealed that only 35-38% of patients (only slightly higher than the rate of placebo response) get a positive response to any SSRI. The other 60+% fail to improve or experience horrible side effects.

What the Congressional Budget Office Found

In 2004, Angell could only estimate what drugs companies were spending on marketing, as this is considered proprietary corporate information. However in 2008, the Congressional Budget Office investigated and came up with the following findings:

  • Drug companies spent approximately $20.5 billion on promotional activities (10.8% of total revenue) in 2008.
  • Drug marketing costs, which grew rapidly between 1988 and 2006 had slowed and had been steady for three years at 10-11%. The CBO felt this was directly related to decreased rate of new drugs coming to market.
  • In 2008 drug companies spent only slightly more on promoting new drugs than they did marketing copycat drugs.

photo credit: NapInterrupted via photopin cc

Medicalizing the Menstrual Cycle

pmd

I have blogged previously (see Menopause: Made in the USA) about the negative effects of the “corporatization” of health care in the US. “Disease mongering” is a particularly nasty one. This occurs when pharmaceutical companies “medicalize” common conditions in order to market drugs that supposedly treat them.

Thanks to skillful marketing, Eli Lilly has turned premenstrual syndrome (PMS) into a profit-making commodity nearly as lucrative as menopause and “childhood bipolar disorder” (see Drug Companies: Killing Kids for Profit).

In 1994, the American Psychiatric Association (APA) included premenstrual dysphoric disorder (PMDD) in their diagnostic manual “as a possible mental disorder requiring more research.” They have continued the diagnosis in DSM V. Although DSM IV lists PMDD as a strictly “research” diagnosis, Eli Lilly immediately seized on it as a genuine disorder and devised a marketing strategy to profit from it.

The Difference Between PMS and PMDD

Approximately 80-90% of women worldwide report physical and emotional changes in the 7-10 days prior to the onset of menstruation. For most women, these consist of minor physical changes similar to those of early pregnancy (water retention, breast swelling and tenderness and abdominal bloating).

Approximately 1/3 of women note mental and emotional changes (aka PMS) – depression, anxiety, fatigue, irritability, insomnia, difficulty concentrating – that have a minor impact on their daily functioning.

Although the APA has yet to agree PMDD even exists as a disorder, there are numerous claims in psychiatric and women’s health literature that approximately 3-8% of women suffer from it. By definition, a woman can only qualify for a PMDD diagnosis if they experience a “marked” decrease in normal functioning due to premenstrual mood changes. A rigorous Swedish study ascertained that the true percentage of women experiencing a “marked” decrease in functioning before their period closer to 1.3%.

A Golden Marketing Opportunity for Eli Lilly

Once the patent on a drug expires, other manufacturers are free to produce cheaper generic versions, resulting in plummeting sales of the original brand name drug. In 1999 Lilly, facing the expiration of its patent on Prozac, exploited the new “diagnosis” of PMDD by re-branding Prozac as a feminine pink and purple tablet called Sarafem.

In 2001, the FDA approved Sarafem for “PMDD,” on the basis of double blind studies involving several hundred women. Lilly reported a 60% response rate in women who took it for five cycles, with greater effectiveness in women who took it continuously throughout the month (as opposed to 7-10 days before their period).

Hopefully psychiatrists aren’t quite so gullible as the FDA, given Prozac’s limited effectiveness in treating depression. Thirty years of double blind studies reveal that depressed patients who take Prozac have an average response rate of 38-40%. In fact, statistical analysis of all randomized controlled trials reveal that all SSRI’s (i.e. Prozac, Zoloft, Paxil, citalopram, etc) are only slightly more effective than a placebos, which works 33-37% of the time.

Skillful Marketing Adds Billions to US Health Care Bill

Charging three dollars per dose for their pink and purple Sarafem tablets (in contrast to 41 cents per dose for generic fluoxetine), Lilly launched a massive marketing campaign to convince women they suffered from PMDD. In 2001, the year Serafem came out, nearly 100,000 prescriptions were sold, reaping Lilly $85 million in profits.

Given the soaring cost of health care in the US (the main reason millions of Americans go without medical care), it strikes me as unethical and immoral to trick doctors and women into wasting nearly a billion dollars on pink and purple pills with a fancy name, when generic fluoxetine would have been equally effective at 1/9 the cost.

Research Evidence for “Natural” Treatments

What I find really fascinating about the PMS/PMDD controversy is that it’s one of the few women’s health “conditions” in which there are more double blind placebo trials of “alternative” or “natural” treatments than medication trials. The three “alternative” treatments that have shown clear effectiveness in randomized controlled trials are omega 3 supplements, Vitamin D and the chaste tree berry or chasteberry. In fact, much of this research suggests that PMS-related mood changes may actually represent a nutritional deficiency of omega 3 and/or Vitamin D.

Omega 3 oil is the most studied in PMS-related mood changes, largely owing to its proven efficacy in depression and large cross cultural studies revealing that populations (for example Asians and Norwegians) consuming large amounts of fish (a primary source of omega 3) in their diets have an extremely low incidence of depression.

Vitamin D, has also proved helpful for depression in double blind studies, especially in elderly depressives suffering from documented Vitamin D deficiency. Other studies show that 1,000 – 2,000 international units of Vitamin D is helpful in alleviating premenstrual symptoms.

This finding correlates with an extremely low incidence of PMS in Asian women. The same oily fish that are a rich source of omega 3 are the only natural food source of Vitamin D (the majority of us derive Vitamin D from exposure to sunlight).

Three double blind studies in the British Medical Journal, the Archives of Gynecology and Obstetrics and the Journal of Women’s Health and Gender-based Medicine reveal that chasteberry helps approximately 52% of women with PMS. Chasteberry is an herbal remedy used by Hippocrates in ancient Greece for pre-menstrual symptoms. It’s believed to work by lowering prolactin (a pituitary hormone influencing milk production). High prolactin levels are a recognized, but infrequent, cause of depression.

Take Home Message: Try Natural Remedies First

In light of all the above studies, common sense would dictate that women who suffer from PMS should try a combination of omega 3 and 1,000-2,000 IU of Vitamin D for a minimum of six months before resorting to either Sarafem or generic fluoxetine. Both have potentially serious long term side effects. Owing to their effect on serotonin receptors in the brain, SSRI’s can be very difficult to stop. Moreover they are associated with a loss of bone density, which increases the risk of osteoporosis and hip fracture in later life, and possibly linked to breast and ovarian cancer

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