Category Archives: Cancer medicine (Oncology)

Your Money or Your Life: America’s Health Care Disaster

It used to be financial planning was a field which provided assistance for the golden years (retirement),  In the U.S. financial planning is necessary for patients to get their health care.  Our amazingly inefficiency expensive (most in the world) health care non-system is now providing such planning to patients to “help” finance their care.  Something is terribly wrong here.

His doctor had prescribed the cancer drug Gleevec, but Steiner’s insurance refused to cover its $3,500 monthly cost. Steiner, a warehouse manager for a publisher of Bible-themed literature, and his wife, Brenda, a part-time nurse, made just $30,000 a year. No way could they afford the drug on their own.

“We still had six kids at home — how were we going to come up with that kind of money?” Steiner said. “We couldn’t re-mortgage the house, because it had already been re-mortgaged. I wouldn’t have been able to take the medication. We would have had to just trust in the Lord.”

It was a scary brush with “financial toxicity,” as researchers call the mix of economic stress, anxiety and depression cancer patients often endure. But then Steiner was assigned to Dan Sherman, an oncology social worker at Mercy Health Lacks Cancer Center who within days got a free supply of Gleevec from the manufacturer. He also made sure it was delivered promptly. The package arrived at Steiner’s home on Christmas Eve, his 46th birthday.

In the eight years since, Steiner has faced a series of medical and financial reversals, and each time Sherman has done as much as any doctor to keep Steiner going — scrambling to get the treatment he needed without sending his family into bankruptcy. “He keeps throwing me life rafts before I sink,” Steiner said.

Read the entire article.

Medicynical Note:  Health care in the U.S. is a special type of hell if you are not independently wealthy.  Something like 60% of bankruptcies in our country are related to medical expenses and it appears from the above article that the first goal of our non-system is to spend all the patient’s savings and then offer assistance.

Our insurance companies’ main goal is to assure profits to share holders, hospitals have a multilevel billing system which ironically bills most those without insurance coverage and least able to pay;  our drug companies think nothing of gouging patients to pad their bottom line, because they can (pretty sadistic); and our medical practitioners often are on their receiving end of payments from technology providers to get them to use the company’s product.  Care of patient is not the primary concern of many in our health care industry.

There are bright spots.  People working to help patient’s figure out the non-system; primary care types working very hard for relatively (compared to some medical specialties) low salaries; our nursing and medical support colleagues who work face to face with patients helping with their care and problems, medical and otherwise.  

The Affordable Care Act is a good first step but more needs to be done.  

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Poster Boy: In Defense of Martin Shkreli, the useful tool

Understand that Martin is the poster boy for the corruptish practices in what was once a self proclaimed “ethical” industry.  In fact the pharmaceutical industry, Big Pharma in the United States, has always run close to ethical boundaries.  Going back to my graduation from medical school, who was there to take the senior class to an expense paid weekend in New York? Why none other than that “ethical” company Ely Lilly.  Some might have called this a conflict of interest for both the new docs and the “ethical” company but when you are a poor struggling senior medical student you are easily bribed.  To this day doctors are targets of drug companies often receiving various forms of payments for either their continued use of products or for listening to the spiels of drug salesmen.  In this relationship there is a very narrow line between legitimate product education and payment for services.

Throughout the next 48 years of my professional life  this so-called “ethical” industry did everything to protect and improve its position.  They have one of the strongest lobbys in D.C., having most of the congress on their payroll—facilitated by our Supreme Court.   In that time we have seen medicine change from an ostensibly doing good industry into a doing well industry.  Patients no longer are viewed as sick people but rather customers for various product lines.  Drugs are no longer developed to help patients but rather to improve company’s bottom lines and yes the sicker the patient the more we can charge, regardless of the cost of drug development.

Getting back to our stooge Shkreli, he has been the focus of our ire for his raising the prices of medications that his company has bought the rights to.  He  gleefully accepted the criticism and cynically shows no contrition.  But consider that his behavior  is standard for the drug industry; that Big Pharma has been gouging U.S. consumers for years; that his companies governing boards have approved of his actions (only removing him because of his alleged earlier criminal behavior).

Some examples of drug company gouging and misbehavior can be found by simply reviewing Medicynic’s archives but to make it easy with a quick googling I came up with these examples.

http://www.businessinsider.com/john-oliver-takes-down-prescription-drug-industry-2015-2

https://projects.propublica.org/docdollars/

http://health.usnews.com/health-news/patient-advice/articles/2015/07/15/how-doctors-make-money-from-drug-companies

http://www.huffingtonpost.com/entry/americans-pay-more-for-drugs-than-anyone-in-the-world_561bda8fe4b0e66ad4c89449

http://money.cnn.com/2015/10/09/investing/drug-ceo-daraprim-price/

http://www.wsj.com/articles/pharmaceutical-companies-buy-rivals-drugs-then-jack-up-the-prices-1430096431

http://www.bloomberg.com/news/articles/2015-09-23/how-marketing-turned-the-epipen-into-a-billion-dollar-business

http://www.wallstreetotc.com/serious-price-increase-for-generic-drugs/212724/

http://www.wallstreetotc.com/serious-price-increase-for-generic-drugs/212724/

Medicynical Note:  And it’s not just generics increasing in price.  New patented cancer drugs start their pricing now at $10,000/month and increase at rates often over 10% a year.  For example, Gleevac (imitinab), a drug for chronic myelogenous leukemia,  was released in 2000 at a price of around $40,000/year it’s now three times that price.  Drug  prices are based on whether there is an alternative and how sick the patient is, not the cost of development.  The fewer the options and the sicker the patient the higher the price.  And yes in the U.S., being the perfect fools, we pay much much more for drugs than anyplace else in the world.  Why?  Because Big Pharma has abused the system and induced  congress to ignore their abuses.

Instead of damning the clown Shkreli, we should be thanking him for bringing the price gouging of Pharma to our attention.  Will anything be done?  For good reason I’m a medicynic, so I don’t think our congress is capable of intervening.  They don’t bite the hands that feed them.  Sad, but that’s American Exceptionalism.

Oncologists Consider Value: About Time!

I suppose coming late to the table, albeit at a great cost to society, is better than missing out completely.  That’s the way I read the recent earth shaking announcement by ASCO (American Society of Clinical Oncology) of a “value framework” for considering cost in the evaluation of a drug.

Drug costs have increased such that new medications for cancer are in the $100,000/year and higher range.  It is  not so surprising  that  doctors buffered by insurers, isolated from the billing procedures and in many instances on the payroll of drug companies have been slow to discover that their patients endure hardships in trying to pay for medications and that drug costs seem disconnected from efficacy.

He said the price of new cancer drugs now averaged about $10,000 a month, and some cost $30,000 a month, which can mean prohibitive co-payments even for some patients with good insurance. “Many cancer patients are facing severe financial strain, even bankruptcy in some cases,” he said.

The value framework envisions considering two costs: the out-of-pocket costs for the patient and the overall cost of a drug to the health system.

Drug companies of course don’t like the idea saying that drug costs are only part of the total cost of care (all of which has inflated in recent years)

But most telling:

Some experts say that ideally, the price of a drug should reflect its value, but that does not seem to be the case with cancer drugs. A recent study by researchers from the National Cancer Institute, published in JAMA Oncology, surveyed cancer drugs approved from 2009 through 2013. It found that prices did not correlate very well with how novel a drug was or whether it prolonged life versus just shrinking tumors.

Medicynical Note:  As I have noted previously our health care non-system is not designed to provide efficient cost effective care but rather to provide revenue to patent holders, insurers and the various providers.  There are no brakes in the system on costs.  The FDA is prohibited by congress (influenced by drug lobbyists) from evaluating cost-efficiency of new products; Medicare is prohibited by congress (influenced by drug lobbyists) from negotiating price or even evaluating value.  And doctors for whatever reason felt it unethical to consider costs when choosing an intervention.   It’s a perfect system for revenue generation but a rolling disaster for patients and society who ultimately have to pay the bills.  It’s bankrupting us.

We lead the world in costs, individual bankruptcy from health care expenditures (unknown in other industrialized countries) and the number of people without health care insurance.  This is not a desirable or viable health care system.

ASCO Meeting: Cancer Drugs Unsustainable Pricing, Getting Worse!

Only on rare occasions does the yearly meeting of oncologists (ASCO) confront the reality of spiraling drug costs for cancer.  After all, the meeting is largely sponsored by drug companies and most of the research oncologists are in the pay of the drug companies (literally and figuratively).  But this year Leonard Saltz raised the issue, as he has done in the past, a more or less lone voice in the wilderness.

Dr. Saltz’s remarks focused mainly on an experimental melanoma treatment made by Bristol-Myers Squibb Co. , but he also criticized pricing more widely. He cited statistics showing that the median monthly price for new cancer drugs in the U.S. had more than doubled in inflation-adjusted dollars from $4,716 in the period from 2000 through 2004 to roughly $9,900 from 2010 through 2014. Dr. Saltz cited studies showing that the price increases haven’t corresponded to increases in the drugs’ effectiveness.

And talking about a new regimen for malignant melanoma:

Dr. Saltz said the combination regimen’s benefit was “truly, truly remarkable for a disease that five years ago we thought was virtually untreatable.” But he said that combining the drugs would cost around $295,000 a patient over nearly one year, which he called unsustainable. If all U.S. patients with metastatic cancer took drugs priced at $295,000 a year, it would cost $174 billion to treat them all for just one year, Dr. Saltz said.

Medicynical Note:  The irony of drug development is that the most effective regimens require the least testing on patients because they work.  It’s the regimens with results that are marginal and maybe not even real that require large randomized studies to prove even a paltry few weeks delay in progression so as to get FDA approval. 

Whatever the cost of development, drug companies price drugs based at least in part on the seriousness of the illness treated.  The more desperate the situation, the higher the price.  A little like “your money or your life.”

Our congress doesn’t allow the FDA to evaluate cost effectiveness of regimens and doesn’t allow Medicare to negotiate prices with drug companies.  After all, the unstated goal of our non-system of health is NOT affordable care for all citizens but rather protection of the profits of patent holders and maintaining the cash flow of some of the most profitable corporations in the country. 

You think that’s why our health care is the most expensive by far in the world but only has average results? 

Psst, in case you are worried about American Exceptionalism, we also lead the world in bankruptcy from health care costs, we’re number 1

Drug Costs Outstripping the Ability to Pay

Health Affairs’ blog had an interesting discussion of the problems of our drug patent system and it’s costly consequences.

One critical incentive for ongoing drug discovery and development is the temporary monopoly pricing that manufacturers can command for novel drugs. Yet this incentive, embedded in current patent and regulatory policy, does not guarantee that manufacturers will deliver novel products with clinically meaningful benefits. Indeed there are many diseases—including Alzheimer’s disease and Amyotrophic lateral sclerosis (ALS)—that pose significant patient, family, and societal burden but have not benefited from meaningful treatment advances.

Meanwhile, the American public appears increasingly wary of the unintended consequences of these market-based incentives. Since the early 2000s, regulatory actions have focused increasing public attention on shortfalls in the efficacy and safety of already marketed drugs — including the withdrawal of celebrated “blockbusters.” Recently, patient and insurer attention has focused on the list prices of novel specialty drugs, including those to treat cancer, that commonly exceed $50,000 per treatment course — these drug prices have also grown faster than all other medical spending.

Medicynical Note:  In the U.S. the medium and average family incomes are about $50-60,000/year.  So we are talking drugs that cost multiples of the annual incomes of families.  A few of these drugs have miraculous effects but most offer slight improvement in patint’s outcomes. 

Other countries try to control these expenditures by providing strong guidelines on expensive medications use; negotiating prices with the manufacturers and suggesting equally or more effective alternatives.   Their costs are significantly less than ours.  The Affordable Care Act has started this process but whether or not it’s political overseers (under the influence of  drug companies contributions)  will allow a rational implementation remains to be seen. 

The Cleopatra Study (Her 2 Positive Metastatic Breast Cancer) Unprecedented Survival, Unaffordable pricing

What happens when there is promising technology for severe illness that is unaffordable? I’m guessing we’ll find out if the results of the Cleopatra study are applied to clinical practice.

The study noted:

Final results from the CLEOPATRA study show that the combination of 2 targeted agents, trastuzumab (Herceptin, Roche/Genentech) and pertuzumab (Perjeta, Roche/Genentech), significantly prolonged survival in HER2-positive metastatic breast cancer, compared with trastuzumab alone. The targeted agents were added to chemotherapy with docetaxel.

Patients treated with the combination plus chemotherapy lived 15.7 months longer than those who received trastuzumab and chemotherapy (median overall survival, 56.5 vs. 40.8 months; hazard ratio [HR], 0.68; P = .0002).

But there is a catch

An added concern is the high cost of dual HER2 inhibition at a time when oncologists are under pressure to contain costs. According to the New York Times, Genentech is putting the wholesale cost of pertuzumab at $5,900/month, which added to the typical $4,500/month costs of trastuzumab, would drive the cost of 18 months of treatment to $187,000.

And this pricing does not include  physician fees, imaging expenses, the cost of the additional chemotherapy (taxanes), laboratory and so on.

Medicynical Note:  The pricing for the two HER 2 blockers used in the Cleopatra study is three time the median income of families in the U.S.   Adding insult to injury, after this huge expenditure the patient is not cured.

The question is who will be able to pay for these drugs?  How will such care be funded by insurers?  And shouldn’t we be able to develop advanced approaches at more reasonable costs? 

As it is the U.S. pays more for everything in healthcare than other places in the world.  We are literally bankrupting ourselves individually and collectively.  There’s something terribly wrong in a health care “system” whose primary goal is revenue generation. 

Cancer Drug Costs: We lead the World

During the periodic American Cancer Society money drives, or at the time of the American Society of Clinical Oncology meetings we are told by fund raisers for cancer charities, drug companies and indeed some institutions out recruiting patients  of the great progress being made in cancer treatment.  What is not clearly revealed is that the great progress in decreased mortality from cancer has not been so much in treatment but rather in prevention (smoking cessation, abandonment of estrogen replacement, etc) and earlier diagnosis mostly from better disease screening.

To me, having practiced from the 70s until 2001, the major revolution in cancer treatment was not cures but costs.  We’ve been talking for several years about the spiraling increase in drug costs and limited benefit of many new drugs—i.e. the disparity between the drug company’s hype and actual outcomes.   Stephen Hall in New York Magazine covers much the same territory in his October 20th article, The Cost of Living.  In the article Hall notes:

Several weeks earlier, Saltz had traveled to Chicago to inflict a little premonitory sticker shock on his medical colleagues. He reviewed the recent clinical results of both Zaltrap and Avastin when used as a “second line” treatment, after initial treatment had failed. As Saltz reminded the other oncologists, Avastin was modestly effective as a second-line treatment—it extended median overall survival by 42 days, the same as Zaltrap—but it cost about $5,000 a month and, like Zaltrap, would have to be taken for many months to achieve that modest clinical benefit. The overall cost was so high that Saltz devoted the end of his talk to a back-of-the-envelope calculation, delivered via PowerPoint, that recast the question in terms of health-care costs: If you extended the 42 days survival to a year, “what is the cost of Avastin for one year of human life saved?”

The answer was astounding, even to doctors who have grown inured to the zero-gravity economics of cancer pharmaceuticals. As Saltz worked his way through slide 73 of 78, he arrived at the bottom line: $303,000.

He notes that this cost is that of the drug alone.  and does not include doctor’s fees, imaging costs and hospitalizations and other costs encountered by seriously ill patients.

Read the article.   Our costs for cancer treatment, like all other modalities of care, are significantly higher than any other country on earth.

Medicynical Note:  For patients it’s a case of your money or your life, But the sad truth is that in advanced disease even if the patient is one of those that has some benefit, it is both.  The question is how much can an individual or health care system afford?