Category Archives: Ethics

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.

Money, Profits and Hospice — Undermining an Essential Program

A review of Hospice spending shows an alarming change in mission goals from patient care and comfort to profits;

From 2005 through 2009, Medicare spending on hospice care rose 70% to $4.31 billion, according to Medicare records.

A recent report by the inspector general for Health and Human Services, which oversees Medicare, found for-profit hospices were paid 29% more per beneficiary than non-profit hospices. Medicare pays for 84% of all hospice patients.

The article highlighted the investigation of the two largest corporate hospice providers and their alleged fraudulent claims.

Medicynical Note: Trolling nursing homes for “hospice appropriate” patients apparently has become a way to increase revenue. It’s bizarre that Hospices thought it necessary to offer services to patients already in full-time nursing facilities. Two service providers, the nursing home and the hospice, being paid for providing what are, for the most part, the same nursing and support services is a irresistible recipe for waste and in this case fraud.

It should be evident that industry seeks to maximize profit. That’s what capitalism is about. In health care that means leveraging control over products and services by testing the limits of programs–in this case illegally increasing the patient base. It’s an irresistible urge that CEO’s simply can’t resist.

Patient care? Value? Cost Efficiency? Not their department.

Medical Info Tainted by Drug Companies Bias — So What Else is New?

Not surprisingly drug companies do everything they can to get doctors to prescribe their products. It matters not that their medications are no better than generics, that their medications cost more than the annual average income in the U.S., that there are other better drugs available. They pay for the ads and for the prominence of the drug recommendations. Take the “wonderful” free app Epocrates: Please.

But like so much else on the Web, “free” comes with a price: doctors must wade through marketing messages on Epocrates that try to sway their choices of which drugs to prescribe.

and:

However, the marketing through Epocrates is more insidious, according to Dr. Adriane Fugh-Berman, an associate professor of medicine at Georgetown University and founder of PharmedOut, a nonprofit group critical of drug companies’ marketing practices.

“With targeted ads in Google, you may buy something that’s an unwise purchase,” she said. “But when a physician is influenced in Epocrates, it’s the patient (Medicynical addendum: and insurer) who’s bearing the financial and health risk.”

Dr. Fugh-Berman and other critics of drug marketing say the apps promote more expensive and sometimes less effective drugs. The companies say they are helping doctors find the best medicines.

Medicynical Note: This type advertising costs us all money, whether we pay directly for the medication or our insurer covers the cost. Doctors have lived too long in the world where cost is not a consideration in their treatment options. We need to encourage value, as well as efficacy, in health care. The U.S. has the most expensive, most inefficient and perhaps only non system of health care operational in the industrialized world. We can do better……..maybe.


Hospice Care – It’s About The Monry

Health, once a charitable calling has become a “business” opportunity.

As hospice care has evolved from its charitable roots into a $14 billion business run mostly for profit, patients like Covington and their families have paid a steep price, according to lawsuits and federal investigations. Providers have been accused of boosting their revenues with patients who aren’t near death and not eligible for hospice — people healthy enough to live a long time with traditional medical care. In hospices, patients give up their rights to “curative” measures because they are presumed to be futile.

And:

In 2009, a Medicare oversight report found nearly a third of hospice patients were not getting services in care plans that describe the treatment and visits providers promise to give them.

Medicynical Note: Left to themselves without standards or oversight, businesses work to maximize profit. In other areas, competition may work to assure quality.  In hospice care such competition may work as well but that remains to be seen.  What is certain, however, is that in the rush for immediate profit patients suffer needlessly.

In our local area, our “non-profit” hospice recently opened an inpatient facility. It was a financial stretch. To pay for it the hospice, it appears, is emphasizing the need for patients to reside in their facilty rather than remain in their home. This increases their payments from medicare and supports the inpatient facility but undermines the desire of many patients to be in their familiar home setting during the last stage of their illnesses.

And, the remarkably dysfunctional House of Representatives voted thursday to decrease the reach and function of the new consumer protection agency. They find it unimaginable that consumers should be protected.

 

Bevacizumab (Avastin) for Breast Cancer, Expensive and Mediocre

Todays NY Times reports that Genentech will try to pressure the FDA to continue the bevacizumab (Avastin) indication for treatment of breast cancer.

It should be stated up front that the drug can be used for breast cancer without FDA approval. The question is whether medicare and other insurers should should be forced (by virtue of the FDA approving the indication) to cover a wildly expensive ineffective treatment.

The data on this drug’s lack of efficacy is clear. It was originally approved in a study which showed a delay in progression of disease. At the time of approval, little was known whether patients so treated would actually live longer. Genentech wanted accelerated approval and agreed that followup studies would be done to confirm its efficacy, not only in delaying progression but also in improving survival.

The F.D.A. approved the drug for advanced breast cancer in February 2008, after one clinical trial showed that combining Avastin with another drug, paclitaxel, delayed the median time before tumors worsened by 5.5 months, compared with using paclitaxel alone. But the women who got Avastin did not live significantly longer than those who got only paclitaxel, which is also known by the brand name Taxol.

and:

Subsequent trials, in which Avastin was combined with different chemotherapy drugs, showed a much smaller delay in tumor progression, ranging from less than 1 month to 2.9 months. And again there was no improvement in survival for those receiving Avastin.

Yet another trial showing this drug’s huge costs and limited efficacy was reported on at ASCO 2011, we commented on this trial here. The study reported .49 years delay of progression free survival and just .135 years (about 1.5 months) of life extension–a cost of $745,000 for a QALY (quality adjust life year). Hardly evidence of a cost-effective intervention, or for that matter a drug that works.

This controversy is in part due to the erosion of standards in clinical trials. At one time patients were deemed to show a response if the tumor decreased in size by 50%. The gold standard for an effective treatment was an improvement in survival, not a mere delay in progression.

It turns out unfortunately that a delay in progression often means little in regard to survival and in the case of bevacizumab (Avastin) even that delay is open to question as repeated studies show a more limited delayed progression as well the lack of a significant survival benefit.

Medicynical Note: With drugs as expensive and ineffective as this one is in breast cancer, it’s easy to understand why health care costs are out of control.


Tax Burden, Health Care: Europe vs the U.S.

Nice article in the NY Times by Bruce Bartlett on the policy choices, taxation and health care, comparing the U.S. and other OECD countries. He notes:

1. The U.S. has very low taxes by international standards:



2. The difference in taxation is to a great degree the payment of health care costs in most industrialized countries by taxation and cash payments (family allowances) made to families in most Euopean countries.

He notes the impact of such payment on taxes:

The impact on the tax burden can be dramatic if one views family allowances as negative taxes. For example, in Luxembourg, an average married worker with two children pays a nominal income tax rate of 16.5 percent (including state and local income taxes), while an American in the same situation would pay 5.2 percent. But once family allowances are subtracted from the Luxembourg worker’s income-tax payment, the effective tax rate falls to just nine-tenths of 1 percent. (Medicynical note: lower than the U.S. )

3. Regarding health care in the U.S. national health insurance covers 72% of expenditures in other OECD countries and just 46.5 % in the U.S.

4. The U.S. pays more for health care than residents in any other major country. And the government share of current health spending that in the U.S. covers a just minority of citizens…

is about the same as total health care costs in many other countries, including (as a percentage of G.D.P.) Luxembourg (6.8 percent), Israel (7.8 percent), Japan (8.1 percent), Britain (8.4 percent) and Norway (8.5 percent).

That is, the proportion of GDP we spend now for just those on medicare, and medicaid in the U.S. non-system covers the total health costs in other countries. We are one of the least efficient, lowest value health care “systems” in the world. Exceptional!

Read the article, it’s short and clear.

Medicynical Note: The solution being offered by Ryan, provides less coverage for those in medicare and medicaid; does nothing about the 50 million uninsured. It will likely cut costs but also cut care provided and result in the deaths of our citizens. Amazingly modest proposal.


Why Our Non-sytstem of Health Care is Bankrupting Us (Provenge, Makena) — While Congress Fiddles, Rome Burns

Two interesting events this week illuminate why health care costs are increasing (by double digit percentages) each year and why they are bankrupting individuals, insurance companies, Medicare, Medicaid, states and indeed the U.S. government.  And while this is happening congress is taking resolute steps to cut NPR’s funding, question individual’s rights to abortion (even in cases of rape, incest and mother’s life risk).  Their budget cuts amount to about 2% of the current budget deficit.  This budget balancing urgency comes after granting a 400 billion dollar a year tax cut.  Remarkable ineptitude.

How health care is  bankrupting us:

1.  Consider the recent rebranding of a long time generic drug hydroxyprogesterone caproate into  Makena.  Without getting into the question of efficacy, consider that hydroxyprogesterone caproate was available for many years at $10-15/ dose from compounding pharmacies.  The branded version of this same exact drug will sell, according to it’s manufacturer, for $1500/dose and the manufacturer expects individuals and insurers to pay.

Now a national pharmaceutical company has gotten FDA approval to make hydroxyprogesterone caproate and will be charging about $1,500 per shot.
KV Pharmaceutical, headquartered in Bridgeton, Mo., received approval Feb. 4 to make and market the drug for the prevention of pre-term labor that for years had been mixed by compounding pharmacies. (at $15, Medicynical clarification)

Medicynical Note:  It’s better than alchemy to be able to make a $15 drug into a $1500 one.  But that’s American ingenuity and creativeness.

2.  Selling a marginally effective drug (Provenge) for $93,000/course of treatment:

Medicare officials said Wednesday that the program will pay the $93,000 cost of prostate cancer drug Provenge, an innovative therapy that typically gives men suffering from an incurable stage of the disease an extra four months to live.

The Centers for Medicare and Medicaid said the biotech drug made by Dendreon Corp. is a “reasonable and necessary” medicine. The decision ensures that millions of men would be able to afford the drug through the government-backed health care coverage. With government reimbursement, analysts estimate Provenge could rack up $1 billion in sales next year. The decision, which will be finalized by June 30, is important for Dendreon because most prostate cancer patients are 65 or older.

Also:

“It’s impossible to put a dollar figure on a human life, especially when you’re talking about a drug that has such mild side effects,” said Jim Kiefert, a prostate cancer patient and advocate who was part of the Provenge study. “Of all the treatments I’ve had — with surgery, radiation and hormone treatment — Provenge had fewer side effects than any of them.”

But bioethicists who study health care decisions say Medicare’s ruling on Provenge mirrors the bias of the overall U.S. health system, which emphasizes expensive treatments over basic medical care. Health care costs account for nearly one fifth of the U.S. economy, more than any other country.

Medicynical Note:  It’s obvious to any thoughtful person that unless the cost of care comes down, we can’t afford our non-system.  We pay twice as much as other similar countries and still have 50 million and climbing uninsured.

Resolving the conundrum of health care costs is a major question that instantly strikes our politicians deaf, dumb and blind.  Even the most innocuous suggestion, for example, comparing the efficacy of new drugs against older less expensive ones, in studies not sponsored by drug companies, is considered controversial.

I’m sad for my grandchildren.

Addendum:  4/1/2011 Drug company slashes price of drug from $1500 to $690. A bargain?  Still only 50 times the price of the generic.  Amazing!

The price of an expensive (? Medicynical question mark) drug to prevent premature births has been cut by more than half, following bitter controversy over its high cost.KV Pharmaceutical Co. said Friday that it is dropping the price from $1,500 per dose to $690.

The company got government approval in February to exclusively make the drug named Makena (mah-KEE’-nah), and it hit the market last month. For years, specialty pharmacies had been making a version of the weekly injection for $10 to $20 a dose, so the price of Makena was a shock to doctors who prescribe the drug and private and public insurance programs that pay for it.

It’s hard to tell what’s real on April fools day.

Moral Hazard? Bad Luck? Or Totally Dysfunctional Health Care

At the annual stroke conference (every disease has it’s conference) it was reported that some patients are not getting optimal care because they are uninsured and/or can’t afford the necessary medications.

The issue of the coverage of health care costs is intensified by the large vocal organized minority (I think) who believe sickness is just another moral hazard for which to hold people accountable.  Their  view  is that the individual bears responsiblity for their illnesses and therefore it’s all right that they should suffer the indignation of having no insurance.  These health care untouchables in their view deserve  relegation to  limited access to care–“they can go to ER’s.”  This tough luck attitude is held whether the  problem is lack of job, access to insurance, high cost of insurance, “pre-existing” illness clauses, accidents, hereditary disease, bad luck……whatever.

This report on strokes is the tip of the 50 million uninsured iceberg that affects health care quality and outcomes in the self proclaimed wealthiest country in the world.

Some stroke survivors skip prescribed medications because the cost is too high — a situation that may be worsening, particularly among young and uninsured patients, researchers found. According to a national survey of stroke survivors conducted from 2006 to 2009, 30% of those ages 45 to 54 and 60% of those who were uninsured reported that they were nonadherent because they could not afford to buy the medication

The current situation, not surpisingly, is worse than reported previously:

Both figures were greater than those reported in a similar survey conducted from 1998 to 2002, when cost-related nonadherence was 18% among those 45 to 54 and 39% among the uninsured,

Medicynical note:  Sad but true.   It is also a fact that the problem is getting worse with many states in the process of cutting subsidized health insurance programs, access to medicaid and working to undermine health care reform.  Only in America, literally.