Category Archives: Ethics

Drug Costs: If Not Patients, Who Pays?

The NY Times had an article earlier in the week bemoaning the increasing costs of expensive drugs for patients.  Insurers are increasing the co-pays and deductibles in an attempt to control their costs and perhaps decrease utilization.

The article cites the case of a hemophiliac boy with drug costs exceeding $100,000/year.  His family cannot afford increased payments of up to 1/3 of the drugs price.

State lawmakers are stepping in:

Spurred by patients and patient advocates like Ms. Kuhn, lawmakers in at least 20 states, from Maine to Hawaii, have introduced bills that would limit out-of-pocket payments by consumers for expensive drugs used to treat diseases like cancer, rheumatoid arthritis, multiple sclerosis and inherited disorders.

Needless to say drug companies who reap excessive profits from these expensive drugs are ecstatic at the notion of lowered copays, anticipating an increase in utilization. 

The article notes that these patent holding companies take advantage

Such drugs account for only 1 percent of total drug use, but 17 percent of drug spending by private insurers, according to IMS Health.

And costs are soaring as more such drugs come to market and as manufacturers raise prices. In 2010, spending on specialty drugs jumped 17.4 percent, compared with only 1.1 percent for other drugs, according to Medco Health Solutions, a pharmacy benefits manager that merged this month with Express Scripts.

Medicynical Note:  The issue here is monopoly, and not the board game.  Our government in hopes of spurring “innovation” provides a generation long monopoly to drug manufacturers who develop  new drugs.  In the past such exclusivity was used judiciously  by drug companies.  Prices for patented agents were high but not so high that they were unaffordable.

In the late 80’s and early 90’s, after the passage of the  Dole-Bayh act, manufacturers were allowed to take private new drug advances developed at universities with government funds.  Everyone, the researchers, the universities and the drug companies became owners of the patent and drove the price of advances up.  More entities on the patent means more people wanting a share of the profits.

The free for all has indeed resulted in new drugs, some very effective, the medication cited for hemophilia and imatinib mesylate (Gleevec) for chronic myelogenous leukemia for example.  But the patent protection afforded  allows companies to apply monopoly pricing to their agents.

Before the 90’s no drug approached a yearly cost of even 1/3 the median U.S. income.  Now on a regular basis for a variety of serious illnesses, drug companies price their agents in the range of $100,000/year and more.  An amount that is almost twice the U.S. median income.  It should be noted that just a few of these new drugs are major advances.  Most offer an incremental benefit  for a small proportion of the patients treated.  But all are marketed to desperate patients willing to try anything to ameliorate their symptoms and/or live longer

The irony is that we’ve developed a new medication “system” that we can’t afford.  Insurers, patients and our government are going broke trying to accommodate drug company pricing. 

It’s a little like trees falling in the woods.  If you have a drug that you can’t afford, is there really a drug?

More on the Court’s (Some Justices) Supreme Indifference

This says it very clearly:

Justice Alito said that if he didn’t buy a Volt, the price of Volts would go up. Where did he learn that? Yale Law School? I hope not; I was there with him and I don’t remember learning that if demand falls, then prices go up. It’s the other way around: if customers won’t buy at a certain price, suppliers lower the price. It’s not that complicated — for most goods and services.

The same is true of vegetables, which is what Justice Scalia cared about. Better he should eat them than make a metaphor out of them.

But insurance is an exception to the normal rule of price being determined by supply and demand. That is because the price of insurance is determined by the risk pool, or in other words the likelihood of needing insurance among the group of purchasers of insurance. Insurers try to avoid selling to those who will actually need the insurance, and cause the insurer to make payments. They wish to deny insurance to those who will likely need it, or they want to charge more money for insurance to those who are likely to need it. (This was why part of Obamacare was to preclude insurers from denying insurance to those who are already sick.)

Read the rest of the article!

Medicynic:  I would have hoped that four of the five conservative justices were smarter than they demonstrated at the hearings on health reform  The fifth, Justice Thomas, is hopelessly compromised as his wife has publically opposed health care reform and the Thomas family has received income from the Liberty Lobby a group opposed to reform.  Amazingly unethical but not surprising that he chose to hear the case. 

Emergency Care Access for Indigent?—Limited in the U.S.

Kaiser Health News notes:

Last year, about 80,000 emergency-room patients at hospitals owned by HCA, the nation’s largest for-profit hospital chain, left without treatment after being told they would have to first pay $150 because they did not have a true emergency.

Sound’s reasonable? 

Physicians worry that sick people will forgo treatment. There is no data on how many who leave the ER without treatment follow up with visits to doctors’ offices or clinics.

“This is a real problem,” said Dr. David Seaberg, president of the American College of Emergency Physicians, who estimated that 2 to 7 percent of patients screened in ERs and found not to have serious problems are admitted to hospitals within 24 hours. (Medicynical emphasis)

“After you’ve done the medical screening, it makes little sense to not go ahead and write a patient a prescription,” said Dr. Michael Zappa, a Boca Raton, Fla., hospital consultant and former president of the Florida College of Emergency Physicians.

Medicynical Note:  ER care is not a solution to the severe health care access problem for the indigent and those lacking insurance.  ER care is the most expensive and most inefficient care in the world.  However, at present, most locations in our country do not have alternative more efficient facilities available.   And when people with medical problems, seemingly “non emergent” are turned away we create an incubator for the development of serious problems.  This is hardly an enlightened or reasonable health care system.

What distinguishes the U.S. health care from that provided in other industrialized countries is that ours is not provided in a systematic organized fashion.  As we’ve noted it is a non-system of care, that is slowly but surely bankrupting us individually and collectively.

Our conservative friends may be in denial but health care reform approaches this ethical medical issue by assuring coverage to almost all of us.

Lung Cancer Treatment: Joe Paterno, a Teaching Moment

At age 85 a person’s life balance is quite fragile.  Medical problems that at a younger age have no effect on the quality or quantity of life can at age 85 have major consequences.  Flu may lead to pneumonia; a simple fall may break a bone and lead to complications; cancer treatments may have life threatening consequences.

At one time aggressively treating a person over age 80 with chemotherapy, much less chemotherapy combined with radiation, would have been unthinkable.  With medical “progress,” however, we believe that we can aggressively treat everyone, including the aged.

This was todays headline:  Joe Paterno, Penn State’s legendary football coach, dies:

Former Penn State head coach Joe Paterno, his body ravaged by chemotherapy and radiation treatments for lung cancer, died early Sunday morning at Mount Nittany Medical Center in State College.

Medicynical Note:  I don’t know how the advantages and disadvantages of treatment were spun to Mr. Paterno by his doctors. 

I can infer from the approach, chemo and radiation, that the disease was nonresectable (not amenable to surgery).  That is, it was either locally advanced or metastatic.  It is a fact that virtually all such patients (young and old) will have  limited benefit from aggressive treatment, and not be cured, regardless of age.  The results of studies in stage 3 and 4 lung cancer range  from  no survival benefit to a  few month’s longer life (median benefit).   Meanwhile many of these patients will have significant side effects, often debilitating and life threatening. 

Regarding those over age 80 and the benefits of lung cancer treatment,  see here:

The > or =80 age group was less likely to be subjected to surgery or chemotherapy, and had inferior outcomes when compared with the 70-79 age group and the <70 age group. Survival improvement was not observed in the > or =80 age group.

Regarding elderly patients with lung cancer: (note the difference between the elderly (age 70-79 and those over age 80)

Evidence supports that elderly patients with good PS and limited comorbidity may benefit from combination chemotherapy. Age alone should not dictate treatment-related decisions in patients with advanced NSCLC. Elderly patients with a good PS enjoy longer survival and a better quality of life when treated with chemotherapy compared with supportive care alone. Caution should be exercised when extrapolating data for elderly patients (aged 70–79 years) to patients aged 80 years or older because only a very small number of patients aged 80 years or older have been enrolled on clinical trials, and the benefit in this group is uncertain. (Medicynical emphasis)

Mr. Paterno’s treatment decision was, I’m sure, his own choice, influenced by his physicians as well as his personal beliefs.  His poor outcome is within the range of expected results for this terrible disease. 

Addendum:  Mr. Paterno is reported to have been diagnosed with small cell cancer of the lung with metastasis at diagnosis.  As with non-small cell lung cancer there is little data indicating a significant benefit for patients over age 80 from aggressive treatment.

The optimal therapeutic approach in older patients remains unclear. A population analysis showed that increasing age was associated with a decreased performance status and increased comorbidity.  Older patients were less likely to be treated with combined chemoradiation therapy, more intensive chemotherapy, and PCI. Older patients were also less likely to respond to therapy and had poorer survival outcomes. Whether this was a result of age and its associated comorbidities or suboptimal treatment delivery remains uncertain.

And:

Among patients with limited disease, the proportion receiving chemoradiation increased from 35% to almost 60% for those aged 60–69, from 28% to 48% in age group 70–74, from 17% to 33% in age group 75–79, but remained <10% for those aged 80+. Among patients with extensive disease, the proportion receiving chemotherapy (CT) decreased from 81% of patients aged 60–64 to 23% of those aged 85+, without substantial changes over time. Survival has only improved for patients <80 years.

Medical Expense Related Bankruptcy—We Lead the World

Our non-system of health care causes many distortions.   Health care costs in the U.S. are the highest in the world, almost double that of other industrialized nations.

Because of escalating costs, lack of job provided coverage, and pre-existing illness over 50 million of our citizens have no health insurance.   Limits in insurance coverage, high deductibles and co-pays make health care increasingly unaffordable.

These costs have driven individuals and families to bankruptcy in increasing numbers as noted in this article which documented that 62% of those going bankrupt in 2007  were driven to it by health bills.

The author’s abstract notes:

Using a conservative definition, 62.1% of all bankruptcies in 2007 were medical; 92% of these medical debtors had medical debts over $5000, or 10% of pretax family income. The rest met criteria for medical bankruptcy because they had lost significant income due to illness or mortgaged a home to pay medical bills. Most medical debtors were well educated, owned homes, and had middle-class occupations. Three quarters had health insurance. Using identical definitions in 2001 and 2007, the share of bankruptcies attributable to medical problems rose by 49.6%. In logistic regression analysis controlling for demographic factors, the odds that a bankruptcy had a medical cause was 2.38-fold higher in 2007 than in 2001.

In 1981 only 8% of bankruptcies were related to medical expenses.   With the current lack of wage growth, the decreasing proportion of people with insurance and the exploding health care costs over the past 10 years (well over 100%) the findings in the article are not surprising. 

For 92% of the medically bankrupt, high medical bills directly contributed to their bankruptcy. Many families with continuous coverage found themselves under-insured, responsible for thousands of dollars in out-of-pocket costs. Others had private coverage but lost it when they became too sick to work.  Nationally, a quarter of firms cancel coverage immediately when an employee suffers a disabling illness; another quarter do so within a year.  Income loss due to illness also was common, but nearly always coupled with high medical bills.

And the U.S. is exceptional:

Medical impoverishment, although common in poor nations,  is almost unheard of in wealthy countries other than the US.  Most provide a stronger safety net of disability income support. All have some form of national health insurance.

Medicynical Note: It’s bad enough that we have adopted an approach that does not have universal coverage and  that our health care costs are rising at an unsustainable rate and that our health insurance provides inadequate coverage. 

It is absolutely obscene however, that when a person gets sick and can’t work, his insurance can be cancelled or made unaffordable by raising the rate.  This is further aggravated by allowing insurers to then deny new coverage because of pre-existing illness.

American health care is set up to provide security and protection to everyone involved except the patient.  Quite an accomplishment if you ask me.

Conflicts of Interest: Drug Company Payments to Doctors: Tysabri

Patients with Multiple sclerosis face a number of potential complications from the drug Tysabri including progressive multifocal leukoencephalopathy (PML) a potentially fatal brain problem.  Patients trying to decide whether or not take this drug apparently are deviled by the question of their doctor’s conflict of interest.  As this patient found out her physician who presumably had her best interest at heart, was also taking funding from the manufacturer of the very expensive medication that he recommended, Tysabri.

Where I live, a state law mandates that payments any doctor receives from a drug company be reported to the Minnesota Board of Pharmacy, which enters it int a public database.

When I looked up my neurologist, what I found was damning. He had received more than $300,000 from drug companies between 2006 and 2008. (The 2009 data weren’t yet available.) Major contributors to this sum were Biogen, the manufacturer of Tysabri and the sponsor of the clinical trial my neurologist suggested to me early on, and Teva Pharmaceuticals, the manufacturer of Copaxone. In addition to many payments for acting as a speaker from these companies, my neurologist also had been compensated for “promotional/marketing consulting services.”

Medicynical Note:  $100,000 here, $100,000 there, soon we’ll be talking real money.  It’s difficult for me to believe that this money didn’t in some way influence the doctor to recommend the medication and influence that patient to participate in a trial of the medication.  Often in such trials, the more patients recruited the higher the payments.

Exceptional Americanism?

This graphic says it all.


Medicynical Note: What’s most striking are the poverty rates: 14% overall, 17% for children, 22% for the elderly and income inequality. Our comparative expenditures on pre-primary education and finally the health rating of our population are also not very encouraging. Exceptional yes, but in the wrong way.


Why Drugs Cost So Much: All Animals Are Equal but Some are More Equal Than Others

The drug industry is lobbying furiously:

The primary trade group for the pharmaceutical industry spent $4.7 million in the second quarter lobbying the federal government on prices that federal health programs pay for prescription medicines and on other issues including patents, drug shortages and reimportation of drugs, according to a quarterly disclosure report.

And:

lobbied on implementation of aspects of the 2010 health care overhaul, including prices and rebates for drugs bought through the Medicare program, strengthening Medicare anti-fraud measures and eliminating an independent payment advisory board meant to hold down Medicare spending.

The article also highlights those former government officials currently lobbying their former colleagues on this issue.

Medicynical Note: Read the article. PhRMA opposes anything that will decrease drug prices. Consumer interest, value, access to less expensive drugs all are opposed by this group.

Since our esteemed Supreme Court ruled that corporations are citizens with equal rights to individuals, it appears that George Orwell’s truism from Animal farm has finally come to fruition. “All animals are equal but some are more equal than others.”


Medical Bribery: Boston Scientific and Payments to Cardiologists

A whistleblower at Madigan Army Medical Center believes he is a victim of retaliation for his efforts. For a time, two cardiologists at Madigan received payments from a medical device manufacturer (Boston Scientific). The cardiology department at the time insisted only on using devices from that manufacturer. The cardiologists, who were found in conflict with the Army’s policy, maintain their patient care judgment was not prejudiced.

Subsequently

Eisenhauer (Medicynical note: the whistleblower) says his own reputation and career came under attack from his supervisors at Madigan, located at Joint Base Lewis-McChord, south of Tacoma. “Not only did they do nothing to correct the situation, they participated in a scheme to run me off,” said Eisenhauer, who was awarded a Bronze Star service medal for his duty in Iraq in 2009. “It was easier to discredit me than address the criminal activity.”

It should be noted that:

investigation resulted in a guilty plea by Maj. Jason Davis, then Madigan’s chief of cardiology, who admitted to taking more than $4,800 in illegal payments from Boston Scientific.

The long-standing practice of drug companies and medical-equipment manufacturers offering doctors free trips, speaking honorariums and other payments is controversial. Critics say the money may often represent kickbacks for favoring a company’s drugs or devices.

Still, in civilian practices such payments are generally considered legal. In the military, however, doctors are prohibited from taking such payments. (Medicynical Note: Not very reassuring)

Read the article for details on the hassles Eisenhauer faced and the reasons he left the military.

Medicynical Note: The problem was deeply rooted at Madigan, and according to Eisenhauer 1.2 million dollars in sole-source acquisitions, presumably in cardiology alone, were pushed through. Imagine the cost if similar practices are extant at other military facilities–as they undoubtedly are.

Consider also the cost implications of such bribery (for lack of a better description) on the more massive civilian health care sector.


Trovan, Nigerian Children and Pfizer’s Inappropriate Drug Trial

Pfizer is in a long running dispute with the Nigerian government and parents regarding children who died during a meningitis epidemic in 1996.

For background from a 2009 article:

Kano’s infectious diseases hospital, a small collection of concrete buildings inside a sandy compound, was overwhelmed, even after teams from Médecins sans Frontières arrived. They were dealing with not one but three epidemics – measles and cholera had broken out as well. Children were being seen and treated in overcrowded halls and corridors. It was chaos.

And then a chartered DC-9 flew in from the US. On board were doctors from Pfizer, the world’s biggest pharmaceutical company, and better medical equipment than the African town had ever seen. They had come to conduct a trial of an oral antibiotic called Trovan, which they wanted to test in children with meningitis against the “gold-standard” treatment of the western world, ceftriaxone. They took over part of the hospital and dosed 200 children, half with Trovan and half with ceftriaxone. And then they left, leaving behind some surplus drugs and equipment for the hospital.

Using a local facility for the purposes of testing a new unproven drug already raises ethical questions. Arriving and in cold-blooded fashion selecting just 200 patients for participation in the trial and then leaving with the epidemic still raging is at least insensitive and at worst, a damning example of the drug company’s opportunistic quest for profits.

Even worse, the Pfizer never intended the drug for use in Africa, the testing against meningitis there was simply a quick and very dirty way to accrue patients.

But the drug is not to be found in African pharmacies. It was trialed on African children, but never intended for Africa. Pfizer aimed to sell it in the USA and Europe – and yet its licence was withdrawn in Europe because of concern over liver toxicity. It is not licensed anywhere for children.

Pfizer maintained that what they did was “ethical” and that they provided the drug free of charge during an epidemic.

A suit is has been in progress in Nigeria and in the process of being settled.

The world’s biggest research-based pharmaceutical company announced on Thursday that it had made payments of $175,000 (£108,000) to each family. More such compensation settlements are expected to follow.

Also:

Legal action filed against the company alleged that some received a dose lower than recommended, leaving many children with brain damage, paralysis or slurred speech.

US-based Pfizer had argued that meningitis and not its antibiotic had led to the deaths of 11 children and harm to dozens of others. But in 2009 it reached a tentative out-of-court settlement with the Kano state government worth $75m.

And:

The cable reported a meeting between Pfizer’s country manager, Enrico Liggeri, and US officials at the Abuja embassy on 9 April 2009. It stated: “According to Liggeri, Pfizer had hired investigators to uncover corruption links to federal attorney general Michael Aondoakaa to expose him and put pressure on him to drop the federal cases.”He said Pfizer’s investigators were passing this information to local media.”

Pfizer has subsequently denied the contents of the cable.

Medicynical Note: Pfizer’s insensitivity is quite remarkable. What’s more cynical than delaying resolving this mess for 15 years? What’s more cynical than testing a drug in a place where you never intend to market it–because it will be too expensive? What’s more cynical and opportunistic than flying in a research team in the middle of an epidemic to do drug trials……and then leaving?

It’s enough to give us all, my profession and the formerly “ethical” drug manufacturing companies, a bad name.