The Clintons have reaped tremendous political rewards through loose regulation of pharma and the financial industry. Goldman Sachs has compensated Hillary Clinton through speaking fees and donations to the Clinton Foundation, Clinton Global Initiative, and political campaigns. Not surprisingly, Clinton has been mum about placing blame for America's unique opioid epidemic on the FDA, pharmaceutical industry or Purdue Pharma.
Americans are weary of millionaire business executives who price-gouge American taxpayers, bankrupt cancer patients at the end-of-life, create opioid epidemics, and make healthcare unaffordable, and the politicians who implicitly condone these practices
Recent developments in the investigation of the multibillionaire family who created the opioid epidemic through fraudulent marketing:
Senator Sanders compares the price of cancer medications in the U.S. and Canada
Pictured Below: Head of the Sackler family, otherwise known as the OxyContin Clan, $14 Billion Newcomer to Forbes Richest Families
Understandably, the public is wary of faster approvals of new drugs and wants drug ads off of TV, a STAT-Harvard poll found. The Food and Drug Administration Modernization Act of 1997, signed into law by Bill Clinton, allowed the faster approval of new drugs that we see today.
In the video below, Vermont Governor Peter Shumlin briefly discusses how difficult it is to regulate the pharmaceutical industry when Congress is legally bribed to give preferences to Big Pharma rather than representing the interests of the American people. Shumlin states:
"But you know, we're up against some big financial pressures here. Just a few years ago, the combined pharmaceutical industry spent $435,000 per member of Congress lobbying for their views, let's just get this out there. $435,000. That's big money. And I'm just asking us, do we have the courage? Do we have the heart...?"
Senator Bernie Sanders of Vermont, otherwise known as the "Amendment King," asks about the pharmaceutical industry:
"Is fraud their business model? The amendment that I am offering would send a strong and clear message to the drug industry. Illegal behavior will not be rewarded with continued government granted monopolies. Virtually every major pharmaceutical company in this country has either been convicted of fraud... i.e. ripping of federal government, state government, or individuals, or else has reached a settlement."
Psychoactive pharma fraud and the opioid epidemic:
40 Years in a Nutshell: Big Pharma Psychoactive Drug Research
Statement from Pikeville, KY, judge Steven Combs on the release of OxyContin trial records:
After a contemptuous appearance (see video) in front of the House Oversight Committee, generic drug price gouger Martin Shkreli went on the offensive via Twitter. Pointed comments were aimed at several members of Congress, including House Oversight and Government Reform Committee Ranking Member Elijah Cummings, who, along with presidential candidate Bernie Sanders, introduced comprehensive legislation to lower soaring drug prices last September (video below).
Are Pharmaceutical Companies to Blame? Politicians and appointed bureaucrats should be blamed for the system they created; a system heavily influenced by lobbyists from the pharmaceutical industry, hospitals, and private insurance. Privatized healthcare and pharmaceutical mishaps (opioid epidemic, mental health in America) combined with misguided drug policy and lack of comprehensive harm reduction measures has been disastrous from a public health standpoint, as explained in the video below. It has cost hundreds of thousands of American lives and will cost taxpayers trillions.
Public health, pharmaceutical, and healthcare policies of the United States have put Caucasians–the major policy-makers in America for quite some time–on a different health trajectory than Germans, French U.S. Latinos, British, Canadians, Australians, and Swedes. Minorities in the United States have historically fared worse on these health measures, without proper attention.
Learn more: Smart Drug Policy and Harm Reduction versus American Self-Harm: Mutually-Assured Self-Destruction of American Government and Its Electorate, the Victims of Greed
Pharmalot: Pharma industry has more in common with Martin Shkreli than it likes to admit
Child Abuse: 20,000 prescriptions for antipsychotics were written for children 2 years old and younger in the U.S. (As a comparison, only 8 children aged 0-4 years old were prescribed these drugs in Sweden)
Faux Morals and Loose Regulation of Psychoactive Drugmakers Trump Mental Health in the United States: Of the children on Medicaid (poor children and those in foster care) who receive antipsychotics, 92% receive them for unapproved uses. (Seniors are also prescribed antipsychotics for unapproved uses)
STAT: "Getting Away with Murder." On the campaign trail, Big Pharma takes a beating
Pie in the Sky? Sanders is an unserious pie-in-the-sky candidate because he wants to rein in campaign spending and institute a health care system that is commonplace in Europe. Clinton, on the other hand, will eradicate sexism and racism in America.
However, lobbyists for Pharma, private insurance, AMA and hospitals paid the Democrat-controlled Congress of 2009 to exclude the "public option" and "Medicare buy-in" from the Affordable Care Act. Ironically, Hillary Clinton recently reintroduced these same plans one year into her campaign in order to garner votes in the final stretch against Bernie Sanders.
Pharma industry contributions to presidential candidates
Getting paid by the companies you might be regulating: Big Pharma's biggest recipient? Clinton. She has collected $336,416 in donations, over a third of the total contributions to candidates.
Two Cases of High-Priced Drugs: Daraprim and pharmaceutical miracle cure for hepatitis C, Sovaldi
Martin Shkreli, former CEO of Turing Pharmaceuticals, hiked the price of decades-old Daraprim from $13.50 to $750 a pill last fall.
Daraprim is used in patients who have toxoplasmosis, an infection that most commonly causes problems in people who are immunocompromised, such as patients with HIV. Toxoplasmosis can also threaten the health of an unborn child if the pregnant mother has not yet been exposed to Toxoplasma and developed antibodies to fight infection. The parasite causes no problems in healthy adults.
While Daraprim might be the worst case of generic pharmaceutical price gouging, the most exhorbitantly-priced brand name medication that isn't a cancer drug is sofosbuvir (Sovaldi), the new miracle cure for hepatitis C. Sofosbuvir is available for $1000 a pill by itself, or $1125 a pill in the combo product, Harvoni. 12 weeks of treatment can cost anywhere from $84,000 to $95,000. Despite the cost to American taxpayers, the drug is a global godsend.
The introduction of sofosbuvir comes at a time when the United States is experiencing an epidemic of hepatitis C infection as a result of increased heroin use. Hepatitis C may lie dormant for years and not cause harm to those who are infected. However, when it become acute, it destroys the liver and kills those who have it unless they are treated with sofosbuvir.
Unfortunately, it's an epidemic that medicine made that is taking lives and costing American taxpayers billions of dollars each year.
The prescription opioid painkiller epidemic transformed into a heroin epidemic, which then turned into a hepatitis C epidemic when states failed to provide adequate support systems and enact proven harm reduction measures, such as syringe exchanges.
In a Senate hearing about price spiking of off-patent drugs such as Daraprim, the panel also discussed the price of patent-protected sofosbuvir. In the hearing (video below), it was revealed that 90% of Hepatitis C patients cannot be treated because of the price of the drug. Medicare budgets for hepatitis C went from $300 million to $4.5 billion, overnight. Sofosbuvir has also busted the budget of the VA, Department of Defense, and prisons.
NY Times: Curing Hepatitis C in Egypt. Indeed, some Egyptian patients seem mystified by their good fortune. ”Do you Americans love Egyptians more than yourselves?” asked Hany Tawfik, 66, a private equity specialist who in 2014 was the first Egyptian to receive sofosbuvir. “Why aren’t you putting pressure on Gilead to sell to you at a reasonable price, too?”
Should Americans pick up and move to other countries where essential medications like Sovaldi and Advair are more affordable? The high costs of insurance, healthcare, and medication prices are not worth going bankrupt.
A partial transcript from the December 9, 2015, Senate hearing about off-patent pharmaceutical pricing featuring Elizabeth Warren can be found below.
Market Watch: Here’s why Daraprim still costs $750 a pill
The New Yorker: Taking on the Drug Profiteers
A surge in acute cases of hepatitis C mirror the number of overdose deaths from heroin.
Claiborne County, TN, jail says most inmates have hepatitis C • Costly Hepatitis C Drugs Threaten To Bust Prison Budgets
JAMA: Ideological Anachronism Involving Needle and Syringe Exchange Programs. Lessons From the Indiana HIV Outbreak
NEJM: Threading the Needle — How to Stop the HIV Outbreak in Rural Indiana
NOTE: An Indiana HIV outbreak finally convinced the culturally-opposed House Republicans to lift a ban on Federal funding of syringe exchanges
Pharm Exec's 2015 Brand of the Year: Sovaldi and Harvoni for Hepatitis C
Sudden Price Spikes in Off-Patent Drugs: Perspectives from the Front Lines
American Society of Health System Pharmacists: Statement for the Record on “Sudden Price Spikes in Off-Patent Drugs: Perspectives from the Front Lines”
Pharmacy Times: Pharmacists Urge Transparency, Payment Updates as Congress Examines Generic Price Spikes
Dr. GERARD ANDERSON, Professor, Health Policy And Management, Medicine, And International Health, Johns Hopkins University: With generic, it's important to have competition. In the brand area, it’s very important to take a look at the patents, when they’re appropriate, when they’re not appropriate, and essentially how long they should be. Because right now, the patent law was originally established during the George Washington administration and was originally for 14 years for 2 years and 2 indentured servants. And now, it’s 17 and 20 years and it’s not reflective of the investment that a drug company makes. Sometimes they invest a lot. Sometimes they invest a little. We need to support the investments and we might want to figure out how to do that differently.
MARK MERRITT, President & CEO, Pharmaceutical Care Management Association: Well, government has a real important role hear, obviously. It’s a huge purchaser. And we think the role is more in ensuring competition, making sure that there are safe products on the market, that people are getting the products that they think they’re getting, insurance that they think they’re getting, and so forth.
And on the purchasing side, the challenge that we see is that it’s such a complicated, fast-moving market. Just like what we did with Imprimis Pharma, this little compounding pharmacy. We found that kind of in real time and it helped drop the price of the products significantly.
And the challenge, if you look at price controls or price interventions, direct negotiations, there are kind of two ways to do it. One, you could peg prices to the market and get a discount on it, which does save money for public programs, but will increase costs elsewhere. Or you can kind of just make the price drug by drug. And the danger there, ironically, is that you can end up overpaying.
As we saw in this Turing thing…I know it’s a temporary solution, but, if a drug’s $5,000 a day, it might seem good to charge $2500 tomorrow, or maybe even $100.
Purdue Pharma: How the American opiate epidemic was started by one pharmaceutical company
The OxyContin Clan: The $14 Billion Newcomer to Forbes 2015 List of Richest U.S. Families
It's a Matter of Conscience: Tackling Greed, Holding Healthcare to a Higher Standard to Protect America's Future
Election 2016: Pitchforks Ready Throughout America, Billionaire Warns
Fight Against Modern Slavery: Student Debt, Criminal Justice Reform, Big Money Interests
Elizabeth Warren: Change Can Happen, Quit Bedding with Billionaires
McCain Feels the Bern: Warns of Military-Industrial-Congressional Complex, Potential Election Defeat to Bernie Sanders or Donald Trump
Senate Aging Committee Hearing on Drug Prices: Faster Generics Approval Could Cut Drug Costs As Senator Tom Tillis reminded his colleagues, it is important to not "cast all pharmaceutical companies in the same light," but instead focus on the few pharmaceutical companies acting as "hedge funds."
Senator Elizabeth Warren: No matter how the drug industry sugarcoats it, the America pays the highest for drug prices in the world. And it’s not impossible to fix, and it doesn’t have to be partisan. Just last month, Congress passed legislation that created a new Medicaid inflation rate for generic drugs, which will require drug companies to rebate money when their prices go up faster than the inflation rate. So we’ve got a lot that we could be doing here. I want to talk more about other countries, but the chairwoman is rightly trying to hold us to our 5 minutes. So I’ll just say thank you very much. You’ve laid out good steps…things we need to investigate. Thank you for starting this.
Bernie Sanders Congressional Panel Videos:
–Bernie Sanders questions FDA commissioner nominee Robert Califf about the high price of prescription drugs and his deep pharmaceutical industry ties.
The first reason Senator Sanders is rejecting Califf's nomination is because the FDA urged a "NO" vote on a drug import bill in 2009 that would have allowed drug reimportation from Canada and possibly reduced drug prices for Americans. Sanders is worried that an FDA chief with close pharmaceutical industry ties would protect industry financial interests over cost concerns of Americans.
Allen Frances: Former chair of the DSM task force tells Kansas senators that psychiatric overdiagnosis hurting America
Have we stopped giving subsidies to Big Pharma for providing educational materials that may be incorrect or misleading, especially for mental health and pain studies that have highly subjective outcome measures?
Matter of Conscience: Tackling Greed, Holding Healthcare and Big Pharma to a Higher Standard to Protect America's Future
Enough is Enough: Bernie Sanders Brings the Heat on Healthcare, Pharma, and the FDA
Kaiser: "Over the past several decades, roughly one-quarter of traditional Medicare spending for health care is for services provided to beneficiaries ages 65 and older in their last year of life."
Cancer's Financial Burden Tied to Poorer Survival: Economic stress may force patients to forgo vital treatments, experts say. Patients suffering from colon, prostate or thyroid cancers who went broke had almost 80 percent higher odds of dying during the study period compared with similar patients who remained financially sound, the researchers said.
As baby boomers near the end of their life in coming decades, end-of-life healthcare costs are only going to increase. Mental health and palliative care offered well before the time of death can help prepare patients and their families for the natural process of dying.
NPR: What If Chemo Doesn't Help You Live Longer Or Better?
A patient caregiver study published in JAMA Oncology titled Chemotherapy Use, Performance Status, and Quality of Life at the End of Life found that "chemotherapy often harmed patients at the end, reducing quality of life, often without extending life, either."
Opdivo ads vs. the reality of stage IV non-small cell lung cancer treatment: $150,000 for the initial treatment, and then $14,000 a month for 90 more days of life
Early palliative care may help terminal cancer patients live longer and could be an addition or alternative to new cancer medications like Opdivo that may prolong life for only 3 months at a cost that approaches $200,000.
Reduced financial burden is another factor that might make early palliative care more favorable than expensive chemotherapy or aggressive life-saving measures in the ICU at the end of life. A recent study found that bankruptcy is a risk factor for earlier death in cancer patients.
CBS: End-of-life care for elderly often too aggressive, study says • Families give insights into end-of-life choices
Many Americans spend their last days in an intensive care unit, subjected to uncomfortable machines or surgeries to prolong their lives at enormous cost: In 2008, Medicare paid $50 billion just for doctor and hospital bills during the last two months of patients' lives - that's more than the budget of the Department of Homeland Security or the Department of Education.
End-of-Life Pain & Palliative Care: An Alternative to Physician-Assisted Suicide
Early Palliative Care: Boosts Survival in NSCLC
FDA expands approved use of Opdivo in advanced lung cancer: The most common type of lung cancer, non-small cell lung cancer (NSCLC), is further divided into two main types named for the kinds of cells found in the cancer – squamous cell and non-squamous cell (which includes adenocarcinoma).Opdivo works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body’s immune cells and some cancer cells). By blocking this pathway, Opdivo may help the body’s immune system fight the cancer cells.
From 8 pages to 1 card: Easier way for patients and families to discuss Advance Directives before the end of life
Journal of Clinical Oncology: Bankruptcy as a Risk Factor for Early Mortality Among Patients With Cancer. (Statistical methods were used to reduce selection bias in this observational study)
The Guardian: Only 3% of over-80s survive CPR and 1.9% of secondary cancer patients. It’s time we doctors stopped meddling and let such patients die with dignity.
End-of-life discussions are now reimbursed by Medicare starting in 2016. Questions remain. Will proper end-of-life counseling be available to most patients and early enough to where patients can make the best end of life choices?
Medicare's Role: End-of-Life Care Questions and Answers
- What is “end-of-life care” and does Medicare cover it?
- What is "advance care planning" and does Medicare cover it?
- Are policymakers, such as CMS or Congress, considering changes in Medicare’s coverage of advance care planning?
- What are “advance directives”? Are health care facilities, such as hospitals or skilled nursing facilities, required to keep records of Medicare patients’ advance directives?
- Does Medicare cover hospice care? How many Medicare beneficiaries use hospice?
- What is “palliative care” and does Medicare cover it?
- How much does Medicare spend on end-of-life care, and for which services?
- Did the Affordable Care Act (ACA) affect Medicare coverage for end-of-life care or advance care planning?
- Has the Institute of Medicine (IOM) made any recommendations regarding advance care planning and end-of-life care?
- How does the public feel about advance care planning and Medicare’s role in end-of-life preferences?
American Psychological Association: Could psilocybin help ease the existential distress common in people with cancer?
Classic hallucinogen psilocybin is currently being studied to help terminally ill patients overcome anxiety. Could psilocybin psychotherapy facilitate difficult end-of-life discussions that are now reimbursable by Medicare?
Psilocybin Psychotherapy for Anxiety in Patients with Advanced-Stage Cancer was published in Archives of General Psychiatry (now JAMA Psychiatry) in 2011. The video below features study author Charlie Grob and Pam Sekuda, a study participant who experienced anxiety after being diagnosed with Stage 4 metastatic terminal colorectal cancer. A Phase II trial is now being conducted at New York University.
In only one or two sessions, psilocybin psychotherapy has the potential to improve how humans psychologically cope with living and dying. In the video below, Dr. David Nichols, Former Distinguished Chair in Pharmacology and Professor Emeritus at Purdue University, asks:
"If you can treat anxiety and depression in people that are dying, why do they have to be dying? If people have chronic anxiety about something or depression, it may be that we'll find treatment so that people don't have to be on antidepressants for years and years and years."
Helping Forgotten Homebound Adults Before End-of-Life: Could Psilocybin Treat Depression and Anxiety in Homebound Older Adults?
HuffPost: Baby Boomers' Last Revolution Will Be Changing the Way We Die, Part 1
Dying Better: An Amazing Moment that is Taking Place in Our Lifetime
Psychology Study Explains Psychedelic Ethics:Awe, the Small Self, and Prosocial Behavior
An open letter to Phil and Penny Knight: Beyond a cure is care
True Hallucinations: Archaic Revival of Time-Tested Psychospiritual Healing Practices
FDA-Approved Drug Therapies and Classic Hallucinogens to Treat Addiction: Barriers, Background, and the Latest Research
NYU Psilocybin Music Playlist: Helping Cancer Patients with Existential Anxiety
Benjamin Franklin: "Nothing Said to Be Certain but Death and Psilocybin's Potential Benefit to Mental Health Treatment and Research"
Top American Psychiatrist: "We Need to Study These Drugs"
This study could help establish an alternative.
Current popular antidepressant medications have significant adverse side effects, with up to 50% of patients failing to respond fully and as many as 30% remaining completely resistant.
See Tim's fundraiser
The study "will determine the efficacy of psilocybin in treatment-resistant depression, and will also use cutting-edge brain imaging to clarify the mechanism of action of psilocybin's antidepressant effects. In the world of science, it is a rare opportunity to be able to conduct such potentially groundbreaking work for a mere $80,000. It’s almost unheard of. Psilocybin has the potential to revolutionize the treatment of major depression that cannot be properly addressed with current treatments. This also applies to end-of-life care for terminally-ill cancer patients." (Follow Psilocybin and Cancer Research on Facebook).
Hallucinogen in 'magic mushrooms' helps longtime smokers quit in Hopkins trial
Researchers enlist Psilocybin to help fight alcoholism
Single Dose of Psilocybin May Create Lasting Change in the Personality Domain of Openness
Psilocybin in the Treatment of Obsessive-Compulsive Disorder
Psilocybin can occasion mystical-type experiences having substantial and sustained personal meaning and spiritual significance
Plant Medicines Looking to Improve American Mental Health
According to Johns Hopkins Magazine, psilocybin researcher Roland Griffiths "would like to add more to his roster of ongoing studies, but he and other researchers are hamstrung by a lack of funding. Despite the much-lauded findings on psilocybin, getting government approval for studies is still difficult.
Griffiths argues that there is too much value in those studies for governments and, possibly, drug manufacturers to ignore. “Scientifically, there’s a lot to get at. We’ve known that primary mystical experiences from hallucinogenic substances have been around for thousands of years. But it’s never really been studied. Now, we can unpack those experiences using functional magnetic resonance imaging and genetics to see how some people are predisposed to such experiences and what that may mean for developing new treatments.”
What’s more, people who suffer from mental illnesses and others that affect the nervous system shouldn’t have to wait longer than they have to for answers, which may come from investigations of substances that have been pariahs for decades, he believes: “It’s far too important not to do this.”"
Psychiatrist Jennie Byrne at Cognitive Psychiatry of Chapel Hill authored Unhappy with Psychiatry, Blame the Healthcare System that blames the business of medicine for America's broken mental health care system. This response sums up the broken mental health care system in the United States:
Due to the high cost and low availability of mental health professionals, primary care physicians provide the bulk of mental health care in the form of writing prescriptions.
Treatment for depression and anxiety are limited to a narrow set of drug options with unpredictable efficacy; antidepressants have a 40% success rate and may take 3-8 weeks to take effect.
Primary care physicians: "...limited access to psychotherapy leaves frustrated doctors with little choice but to prescribe medication, or provide brief sessions of therapy themselves despite receiving little training in the area."
Why psychiatrists don't take insurance
"We think it looks like we're tapping into the basic biology of the human condition in which these salient experiences of interconnectedness emerge. And if you really sit back and reflect on it in the history of humankind, those are the kinds of experiences that really form the bedrock foundation of most of the world's religions and the world's ethical and moral traditions." –Roland Griffiths, Psychopharmacologist at Johns Hopkins University School of Medicine, recipient of the 2015 Nathan B. Eddy Award from the College on Problems of Drug Dependence, Speaker at TedMed2015: Breaking Through
Bringing the Heat: Why Bring the Heat on Healthcare, Pharma, and the FDA?
Failing America: Politicians Lack Courage on Harm Reduction & Drug Policy Reform
Presidential Politics: Getting Between American Cultural Institutions and the Next Overdose Epidemic
Politics and Faux Morals Trump American Health
European Take on America's War on Marijuana
In the years before 1962, Senator Estes Kefauver had held hearings on drug costs, the sorry state of science supporting drug effectiveness, and the fantastic claims made in labeling and advertising. Read more...