The answer is you keep on hiking the price, year after year, up and up and UP.

Let me back up a but, before I explode…

Just for once, Big Pharma has a worthwhile product, it works, and it brings the life expectancy of a relentlessly fatal disease almost back to normal. It’s not often that drugs can completely transform the trajectory of a killer disease – but for chronic myeloid leukemia, that is what tyrosine kinase inhibitors (TKIs) have done.

(CLL is characterized by overwhelming quantities of white cells (leukocytes, stained purple) in the blood; hence leukemia)

Before these drugs came along, there were about 20,000 patients with CML in the United States. Now there are about 112,000 such patients, and that projected to rise to 180,000 in 2050.

However, the catch is that patients need to stay on the drug indefinitely. And this is an issue, because these drugs are very expensive indeed. The high prices [if TKIs] has been described by caring doctors (not so many of those) as a scandal – they cost an exorbitant amount and put an enormous financial burden on patients and their families and the healthcare system.

So everyone was hoping that when the first of this class of drugs – Imatinib – Came off patent, generic versions would reduce cost of treatment.

Ludicrous Pricing

When Imatinib entered the marketplace in 2001, it was priced at about $30,000 a year. That remained flat for a while and then rose steeply. By 2012 it was priced at $92,000, and then jumped to $132,000 in 2014, and then to $146,000 in 2016 when the generic version became available. This is in a country where the median household income is around $63,000, according to official 2018 figures.

Surely, the generic version would be much cheaper than that? But it was not to be. See, Novartis cut what’s called a pay-for-delay deal. What’s that, you ask? The patent holder – in this case Novartis – agrees to pay a potential competitor a large sum of money to keep their product out of the market for a time. Tey calculate the cost of the deal is less than the extra profit they stand to make.

With cars it could (maybe) be considered a clever strategy. But with a life-saving pharmaceutical product IT IS NOTHING SHORT OF OBSCENE.

Thousands more died, while Novartis went on harvesting its greedy profits, stamping out any hope of an affordable cure.

One always has to consider that mass protests are sometimes staged. But I think it’s pretty clear that the Indian people are telling Novartis where to shove its patent!

Eventually a generic entered the US market in early 2016. Because of tricky laws, the generic company (a subsidiary of Sun Pharmaceuticals Industries) was tentitled to 6 months of marketing exclusivity. That mean that no other generic versions of Imatinib could be launched in the US until at least August 2016.

The generic was priced just a few thousand dollars less than the branded Imatinib. In 2016, branded Imatinib cost $146,000 pr year, while the generic version was priced at $140,000.

It makes me so angry.

Ski-High Cancer Drug Prices

The US has the dubious distinction of having the highest expenditures in healthcare, but ranks far from the top in terms improvement in life expectancy. Part of this is driven by the cancer drug experience, and healthcare costs have risen faster then gross domestic product!

Cost escalation began in the early 2000s, and eventually exceeded the median household income of a typical family. The price tag of any new cancer drugs now exceeds $10,000 per month ($120,000 annually).

This has been described as ‘financial toxicity’ which comes on top of the usual toxicity of cancer treatment, and cam limit treatment decisions, access to care, and affect outcomes.

But it’s not just a burden on patients. It’s a burden to society as a whole. These monstrous corporations have wormed themselves into a position where they are, in effect, a horrendous additional tax on us all, sick or not.

I’ve railed for decades that the UK has supposedly socialized medical system. But they didn’t “nationalize” (take ownership) of the drug companies. Therefore British citizens pay a heavy common “tax” that goes straight pay a heavy common “tax” that goes straight to the private coffers of Big Pharma. Not the utopian ideal that the socialists like the boast about, is it?

But here’s the bit that made me rage and rush to my keyboard: in the USA the generic Imatanib was almost as expensive as the branded product. It’s held artificially high everyone can get a slice of the lucrative cake, while patients die in large numbers because they are not in on the game.

Contrast that price-fixing with other countries as follows: in Canada, the patended product cost $38,000, whereas the generic was priced between $5000 to $8000; the generic in India… are you ready for this?

… runs at about $400.

$146,000 (current) vs. $400. The price in India is not a charity figure; they make a profit! Go figure.

We have a clear disconnect between pricing in the US and what’s available in the rest of the world.

Things are Improving (slightly)

At the beginning of 2018 the average price for Imatinib was about $2000 for a 30-day supple, whereas through September 2017, the price was about four times higher (roughly $8000).

Approached for comment, Stacie B. Dusetzina, PhD, associate professor of health policy and associate professor of cancer research at Vanderbilt University School of Medicine in Nashville, Tennessee, was cautiously optimistic, noting that prices of generic products have very recently fallen.

With more competition now, the price should drop even lower. Coupons offered through places like GoodRx will allow patients to purchase a month’s supple of the drug for a few hundred dollars. The lowest price was at Costco, where a 30-day supply of 400 mg tablets sold for $245.74 which is 97% off the average retail price of $11,475.

Despite that, in 2017, generic Imatinib represented still only 28% of prescriptions for newly diagnosed patients. Of course there is the usual vicious disinformation by Big Pharma, that generics are “dangerous”, or they don’t work as well. All of it bullshit… there, see? They are making me cuss.

Maybe patients who can afford it should fly to India, have a nice holiday in the land of the Maharajahs, and fly home with a year’s supple of the generic, all for less than cost of a month’s Big Pharma prescription.

I’m on the scientific advisory board to an Indian company and I have no problem with their standards.

Neither, it seems, do Novartis and others: they have all their branded products made in India, the same place as the generics. Do I smell hypocrisy? Or is it the stench of B*S? (ooops, there, I nearly said it again).

Prof. Keith Scott-Mumby

The Official Alternative Doctor

SOURCE:

American Society of Hematology (ASH) 2019. Presented December 7, 2019.

Do NOT eat manufactured foods. You’ll be fine. Sooner or later you are going to have to make this change, otherwise you will just grow old, get sick, and die young, and feel bad. Why not make the change right away? Then you can enjoy your remaining years in good health. You choose.

If you want to take indigestion seriously, get a copy of my book Diet Wise and figure out which are the right foods for YOU (forget the lame advice about spices, curries, fried food, red wine and all the usual garbage—any food can cause indigestion, if it’s not right for your body).

LINK: https://www.dietwisebook.com/

That’s not really what I’m writing about today.

Unless you live on the Planet Zod, you will have noticed a huge recall for generic Zantac (ranitidine, its real name). It’s found to be contaminated with a probable carcinogen. Sandoz, the manufacturers have also issued a recall for their own branded drug. That’s very big hearted of them—except when you remember that the patent has run out and they now have to compete with cheaper, generic alternatives! (call me cynical, Ha!)

As usual, the FDA is being very bossy and unhelpful, getting in everybody’s way, when there’s a job to be done.

Enter a web-based pharmacy, called Valisure. They perform their own tests on drugs they carry (that’s good!) and initially alerted the FDA to the ranitidine contamination issues in June 2019. It then filed a Citizen Petition in September urging the FDA to pull all ranitidine from the market.

That set off the furore. But says Valisure, the Zantac that’s being shelved across the country isn’t necessarily “contaminated” with a foreign chemical. More likely, ranitidine itself converts into this carcinogen, which is called N-nitrosodimethylamine (NDMA) or sometimes, dimethylnitrosamine (DMN)ma.

Nitrosamine, you may know, is a breakdown product of nitrates and nitrites used as a food preservative. Nitrites are used for processed meats and is the REAL reason “red meats” get a bad name. Red meats are GREAT for us, but studies ALWAYS lump processed filth (like “pink slime”) into the testing and then declare against red meat. Duh! We do know that consuming processed meats is strongly linked to an increased risk of cancer in the digestive tract, and many people, me included, believe that the nitrates/nitrites are the reason for that.

Let’s do what the cosmetics companies call the science bit!…

NDMA is a semi-volatile organic chemical, produced as by-product of several industrial processes and present at very low levels in certain foodstuffs, especially those cooked, smoked, or cured. It is toxic to the liver and other organs and is a probable human carcinogen. It is also used to create cancer in rats for cancer research.

NMDA is also used in the manufacture of a component of rocket fuel. It’s a problem in treatment by chlorination or chloramination of organic nitrogen-containing wastewater, because NDMA is produced as a side effect.

Further, NDMA is found at low levels in numerous items of human consumption, including cured meat, fish, beer, tobacco smoke and as an impurity in pharmaceuticals.

So What’s The Problem (Apart from Poisoning Us?)

“The fundamental problem is that [ranitidine is] an unstable molecule,” David Light, CEO of Valisure, told MedPage. “The drug itself can directly degrade and form, with very high efficiency, NDMA.”

The FDA had to step in to save businesses and jobs, by claiming (falsely) that Valisure’s testing method is “not suitable for testing ranitidine because heating the sample generates NDMA.”

How much of a lie is that? It’s exactly the same method as the one the FDA uses to reveal NDMA in angiotensin receptor blockers (ARBs)—it involves heating the compound to 130 °C, or about 266 °F!

FDA said a protocol that doesn’t use elevated temperatures should be deployed instead, and this has revealed lower levels of NDMA in ranitidine—although the agency at least admitted that those levels are “unacceptable.”

David Light argued that other studies using other conditions also showed NDMA as a ranitidine breakdown product, including exposure to chlorine (particularly in wastewater treatment plants) and ozone.

Even a hot car in transit could do it, Light said.

Some tests mimicking the stomach environment have shown that ranitidine yielded 300,000 ng of NDMA from a 150-mg tablet.

That’s more than 3,000 times the level the FDA set when it had to decide how much NDMA could be tolerated in angiotensin receptor blockers (ARBs).

William Mitch, PhD, of Stanford University, co-authored a 2016 paper that found an average of 48,000 nanograms of NDMA in 24-hour urinary excretion after participants took a 150-mg ranitidine dose, a 400-fold spike from baseline.

“We don’t know if the ranitidine was converted to NDMA in the stomach or in the body (e.g., liver), because we only measured the urine,” Mitch said in an email to MedPage. “But we suspect some conversion in the body since the levels we were seeing were higher than previous measurements of NDMA in human gastric juice after ranitidine consumption.”

While FDA hasn’t ordered a recall of ranitidine products, other countries — including Canada, Germany, France, Italy, Switzerland, and Austria — have done so, and major U.S. retailers including CVS, Walmart, Walgreens, and Rite-Aid have pulled all ranitidine including branded Zantac from store shelves.

Sandoz and Apotex have voluntarily recalled their versions.

The FDA is wrong, damnably wrong. They are trying to force this as a contamination issue and it isn’t. It’s a biodegradation issue (metabolic conversion).

“Contamination is almost irrelevant compared with the fundamental instability of this drug,” said David Light. I trust him but not FDA officers.

Valisure launched about a year ago, positioning itself as a pharmacy, a lab, and a wholesaler. Now licensed in 38 states and with a staff of 12 in Yale University’s Science Park in New Haven, Connecticut, it analyzes some 2,000 compounds — mainly generics, and now some brands—to introduce a level of online drug quality control into the system that Light says didn’t exist before.

With fears of contamination (fuelled by pharmaceutical companies to scare people off the cheaper competition), it’s smart to analyze drugs at the point of consumption. I do NOT trust Chinese manufacturing. However, I have no issue with products from India.

Valisure, incidentally, was the first to detect the industrial solvent dimethylformamide (DMF) in the drug valsartan. DMF is also classified by the WHO as a probable carcinogen.

Given ranitidine’s popularity, physicians are facing questions from patients about whether they should be tossing it from their medicine cabinets.

My advice to you is to toss it and clean up your diet. THERE IS ABSOLUTELY NO REASON FOR GERD, SO-CALLED, OR INDIGESTION, EXCEPT EATING THE WRONG FOODS FOR YOUR UNIQUE BODY.

Why do it?

Prof. Keith Scott-Mumby

The Official Alternative Doctor

That link again, only if you ARE really serious: www.DietWiseBook.com

And if Valisure appeals to you (I have no financial connection with them) you might like to visit their website: www.valisure.com

NOTES: Medpage Today: by Kristina Fiore, Director of Enterprise & Investigative Reporting, MedPage Today, October 03, 2019

https://www.medpagetoday.com/gastroenterology/gerd/82550

Renal failure occurs when your kidneys are suddenly unable to filter waste matter from your blood.  Dangerous toxins build up quickly in your system and result in acute kidney failure in as little as a few days.  There have been cases that have advanced to the critical point within hours!

Once your kidneys reach end-stage renal failure, you will be unable to survive without a transplant or long-term dialysis (mechanical device that filters your blood for you).  

There may be no symptoms that something is wrong until lab work is done for another condition.  If you do experience symptoms, it is crucial that you immediately seek medical attention. When your kidneys fail – truly fail – your options are severely limited.  The need for kidneys far outweighs the available supply.  

Common Symptoms of Kidney Failure

• Lower output of urine
• Pain or pressure in the chest
• Retention of fluids that results in swelling of the limbs
• Seizure
• Fatigue or perpetual drowsiness
• Nausea or loss of appetite
• Difficulty breathing
• Mental confusion

Acute kidney failure is typically your body’s response to another medical event or condition.  If you have a history of kidney, liver, or heart disease, diabetes, are of advanced age, or have been hospitalized for a serious condition (especially for surgical or intensive care), your risk of is higher than you might imagine.  

Risk Factors Include

• Poor lifestyle choices such as obesity, lack of nutrition, and smoking
• Slow or impaired blood flow to your kidneys
• Blood loss (even in surgical conditions)
• Blockages to your kidney drainage tubes (such as kidney stones)
• Long-term use of aspirin, ibuprofen, naproxen, or similar over-the-counter drugs
• Repeated or prolonged dehydration
• Blood clots in or around the kidneys or urinary tract
• Chronic infection and inflammation
• Impact injuries to the kidneys
• Autoimmune disorders such as lupus
• Chemotherapy drugs, imaging test dyes, antibiotics, and osteoporosis drugs
• High-level toxic substances such as illegal drugs or heavy metal exposure
• Excessive alcohol consumption
• Reproductive or endocrine system cancers

Dr. Alex Chang, M.D. with Johns Hopkins University stated, “Unlike family history of kidney disease, diet, smoking, and obesity are modifiable lifestyle factors that we can all control.  By eating well, quitting smoking, and maintaining a normal weight, people can protect their kidneys and prevent future damage.”  

The results of his kidney disease research were published in the American Journal of Kidney Disease.  Dr. Chang and his team determined that people who are obese have double the risk of developing kidney disease and those who smoke are 60% more likely to lose the use of their kidneys.

Before your kidneys go past the point of no return, you need to read my book!  Inside the pages of The Waters of Life, you’ll learn how to prevent and even reverse kidney disease right now!  Without trying to buy someone’s black market organ!

What You’ll Discover Inside

• Kidney disease statistics
• Hidden kidney disease
• Causes of kidney failure
• Nephrotic syndrome (the inflamed, leaky kidney)
• Understanding end-stage renal disease (ESRD)
• Dialysis (and why you don’t want it!)
• Facts about kidney cancer
• Kidney tests explained
• Treatment for kidney disease
• What you should do to look after your kidneys
• How and why to detox safely to avoid damaging your kidneys
• Kidney stones (the myths get busted)
• The “bump and jump” method to dislodge stuck stones
• Preventing recurrence of stones
• Herbs for kidney health
• Homeopathic kidney formulas
• Drink only quality waters (a review of water filters)

Your liver and kidneys are two of the most important organs in your body. They help you digest food, flush out toxins, regulate blood pressure and maintain a healthy heart.

But sometimes they need a little extra help to do their jobs properly. To keep them in tip-top health. You need to KNOW what to do and a good chunk of WHY you should do it.

I have one final comment and I hope you take it seriously.  Do not wait until you are told you have extensive kidney damage or even kidney failure.  Remember, you won’t know until it’s almost too late!  Kidneys are the “silent” killer.

Start today on protecting your body’s filtration system.  Pick up your copy of The Waters of Life right now!

US Department of Health and Human Services: Kidney Disease Statistics for the United States https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease

National Kidney Foundation: The Right Diet May Help Prevent Kidney Disease, New Study Finds https://www.kidney.org/news/newsroom/nr/Right-Diet-May-Help-Prevent-KD

Well, according to a study it’s true. When choosing their own treatment, doctors often do something different to what they tell their patients. Sometimes, very different.

For example, a doctor would not choose an option he or she knew could be fatal—even though he or she was quite happy to recommend that course to a patient! Doctors, it would seem, would rather be paralyzed or in some way disadvantaged than dead. Fair enough. But why don’t they take the same line with a patient?

All this came to light form a study published in the April 11 issue of the Archives of Internal Medicine.

“It’s a pretty clear message: There’s a discrepancy between what doctors recommend to their patients and to themselves,” said Dr. Timothy Quill, author of an accompanying editorial in the journal.

In the study, Dr. Peter A. Ubel, a physician and behavioral scientist at Duke University ,and his colleagues presented one of two different treatment-decision scenarios to primary care physicians in the United States.

For the first scenario, 242 doctors were told that either they or a patient had just been diagnosed with colon cancer and could choose one of two surgeries. Both options had a cure rate of 80%, but one had a higher death rate and fewer side effects. The other had a lower death rate but patients were more likely to need a colostomy or to have chronic diarrhea, intermittent bowel obstruction or wound infection.

When it came to their own bodies and lives, 37.8% of physicians chose the option with higher mortality over fewer side effects, but only 24.5% thought that patients should choose this course.

The second scenario involved being infected with a fictitious new strain of avian flu. The flu itself had a 10% death rate and would send 30% of patients to the hospital for an average of one week.

The one treatment would halve the rate of adverse events, but would kill 1% of recipients and cause permanent paralysis in 4%.

Of the nearly 700 doctors completing this survey, 62.9% decided that they personally would endure the flu rather than get this treatment. For their patients, however, only about half (48.5%) recommended foregoing treatment in the event of infection.

I would say hypocrisy is fair comment, wouldn’t you?

SOURCE: April 11, 2011 Archives of Internal Medicine