Category Archives: Patents

Lilly Gross Profit of 84%– Show No Mercy

Lilly announced an earnings increase of 23% over last year’s results.

“Lilly, which reiterated its 2009 earnings target, is among a slew of pharmaceutical firms that have raised some prices aggressively.” in recent months even as government and private insurers struggle to rein in health care costs.”

“Gross margin rose to 83.8% from 76.9% (Medicynical emphasis) as the stronger dollar eased international sales costs. Total sales costs slumped 27%.”

Investopedia defines gross margin as “A financial metric used to assess a firm’s financial health by revealing the proportion of money left over from revenues after accounting for the cost of goods sold.Gross Profit = Revenue − Cost of Goods Sold.”

Medicynical Note: Big profits, seemingly defying the pull of gravity (the current financial crisis). It would seem to me that 86% margin is excessive. But then what is excess profits in a capitalistic society? The larger question is can we afford this level of profits in health care? How to limit? Should we limit?

New advances that we cannot afford have the same impact as trees falling in the woods.

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BIG PHarma–price increases over twice the rate of inflation!!

AARP is not the most reliable unbiased source, given it’s Medicare D insurance business. But it notes:

“manufacturer prices for widely used brand name prescription drugs jumped by nearly nine percent (Medicynical emphasis) in 2008, marking the largest average annual increase in six years and far exceeding the general inflation rate of just 3.8 percent.”

Big Pharma just can’t resist.

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Cost Containment

The Columbia Journalism Review has an interview with Medicare expert Marilyn Moon, vice president of the American Institutes for Research, and a former trustee of the Medicare system:

“No one has really solved the cost containment problem in this country, but Medicare has done as well as any other effort. Rising costs are not a Medicare problem but a health system problem. We have not been willing to make sure we are getting value for the dollars we spend. We have not been spending money wisely. Until everyone-providers, patients, and others who have a stake in manufacturing drugs, devices, new treatments-becomes realistic in what the system will bear, we are not going to see any reduction in the growth of health care spending.”

Medicynical Note: What will get their attention? Patent reform? The threat of a single provider system? Increased regulation of insurers? More out of pocket expenses (HSA’s)? What’s clear is something needs to be done. LBJ had an approach: “Son, it’s really simple. You grab ’em firmly by the balls. Their hearts and minds will follow.”

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Arguing Against Comparison Studies– Anti-intellectualism or Greed?

It’s hard to believe that one can argue against learning what works. But that’s exactly the position of drug and device makers in this article in the Wall Street Journal. It’s hard to believe that this is an issue.

At a minimum such studies will guide physicians in explaining benefits of, risks from and alternatives to various treatments. Comparisons will also help with analyzing the cost-effectiveness of various interventions. Whether insurers will use such data to decide what they will and will not cover is an open question.

My question is when new drugs are prohibitively expensive and have minimal effect on disease course, should insurers pay for their use? Should doctors recommend their use? Should there be limits on “choice” in health care when someone else is paying?

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Costs, the elephant in the universal health care closet

The Massachusetts health plan is looking at better ways to finance their universal system. With universal coverage expenditures/capita have risen above the already outrageous national average of about $8,000/year.

“They want a new payment method that rewards prevention and the effective control of chronic disease, instead of the current system, which pays according to the quantity of care provided.

It appears it was a mistake not to control costs in the first place:

“Those who led the 2006 effort said it would not have been feasible to enact universal coverage if the legislation had required heavy cost controls. The very stakeholders who were coaxed into the tent – doctors, hospitals, insurers and consumer groups – would probably have been driven into opposition by efforts to reduce their revenues and constrain their medical practices, they said.”

Some good things are happening:

“Frankly, it’s very hard for the average consumer, or frankly the average governor, to understand how some of these companies can have the margins they do and the annual increases in premiums that they do,”

“Insurers seeking to participate in the state’s subsidized insurance program, Commonwealth Care, recently submitted bids so low that officials announced last week that they would keep premiums flat in the coming year.”

But:

“Some health policy experts argue that changes in payment practices will not be enough to slow the growth in spending, even when combined with other cost-cutting strategies. To truly change course, they say, the state and federal governments may need to place actual limits on health spending, which could lead to rationing of care.”

Medicynical note: In a system that has institutionalized excess expenditure at every level change is difficult. We need to look at every level in the supply chain and question costs and demand more efficiency. Cutting some of the fat out of the insurance business is a start. I’ve focused on reforming patents in the past and that’s also a possibility.

Lastly we already ration care by cost. In oncology for example, patient delay is a significant cause of morbidity and mortality. People who can’t afford to pay simply delay or completely forgo treatments.

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Patents and Generic Drugs

President Obama is addressing the issue of moving generic drugs more quickly to market. Big PHARMA has had it’s way for the last 60 years with cost increases for medications far above the inflation rate. We now have drugs, single medications, that cost more than automobiles and over a lifetime more than the average home. Imagine, a single drug being the most expensive purchase of a lifetime. That’s the unsustainable monster we’ve created. More here from the Washington Monthly.

A medicynical approach would be to have market based patent durations. If priced reasonably a full patent would be awarded, if priced excessively the length of patent would be proportionally reduced. The devil, of course, is in the details.

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Litigate to delay

Pay to delay is strategy of pharmaceutical companies whereby the owners of a drug patent pay (bribe?) generic manufactureres to not market generic competition for their patented agent.

“lucrative settlements between generic and branded drugmakers have flourished. According to the FTC, nearly half of all settlements between 2006 and 2007 involved payments to keep low-cost drugs off the market.”

Imagine, our non-system facilitates keeping drug costs high. What a system.

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Monopoly Medicine– Ovation Pharmaceuticals, Is This Some Kind of Joke?

It’s hard to believe that “antitrust” enforcers are accusing a drug company of monopolistic practices for a drug that costs $500 dollars for a complete course of treatment. While I certainly agree that the price increase noted in the article ($36 to about $500) is not supportable by the cost of development and manufacture, there are far worse, and more costly, examples of drug patent monopoly abuses.

Consider, for example, drugs under patent that are used in patients with fatal and or debilitating disease that cost a much as $10,000/month and over $100,000/year–more than the average and median income/year in the U.S. These new drugs have, for the most part, limited efficacy and represent an incremental improvement in treatment and outcomes. Their development costs are often subsidized with tax funds and their pricing inflated by inefficiency, marketing costs and greed.

While I consider the issue of Ovation drugs for patent ductus is significant, the drug cost involved is trifling compared to the other abuses of the pharmaceutical industry.

We need patent reform. Medicynical views have been outlined here and here.

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Drug Prices– Patent Reform is Essential to Health Care reform

Fascinating article on the use of cost efficacy data to determine coverage in the U.K. The scheme in the U.K utilizes an impartial board the National Institute for Health and Clinical evidence (NICE) to look at evidence based results and the costs of medications. They then recommend for coverage based on the efficacy and the availability of resources to pay in the system. A rational approach? Rationing?

Both! With single drugs alone costing more than the median and average incomes in our countries we need to evaluate what their use actually accomplishes. In the U.S. we implicitly ration and have done so for many years by pricing insurance beyond the capability of many citizens (50 million approximately) and adding deductibles and co-pays that put many new drugs beyond the reach of patients.

The Time article points out the industry attitude:

“but industry advocates were not so kind. Robert Goldberg, vice president of the Center for Medicine in the Public Interest, an advocacy group financed by drug makers, likened Dr. Rawlins and his institute to terrorists and said their decisions were morally indefensible.”

Despite this a great number of countries are implementing similar schemes.

“For years, Britain was almost alone in using evidence of cost-effectiveness to decide what to pay for. But skyrocketing prices for drugs and medical devices have led a growing number of countries to ask the hardest of questions: How much is life worth? For many, NICE has the answer.”

“Top health officials in Austria, Brazil, Colombia and Thailand said in interviews that NICE now strongly influences their policies.”

“”All the middle-income countries – in Eastern Europe, Central and South America, the Middle East and all over Asia – are aware of NICE and are thinking about setting up something similar,” said Dr. Andreas Seiter, a senior health specialist at the World Bank.”

In fact the problem of drug pricing is based on drug company greed and inefficiency. The Pharmaceutical industry spends far more on marketing than research; rewards company executives and patent holders extravagantly; and ignores tax funded public supported research’s contribution to new drugs. Medicynic has pointed out the minimal drug company investment necessary for the drug imatinib (Gleevac), priced at over $50,000/year. The Time article points out other abuses.

“Celgene’s first big seller was thalidomide, a decades-old medicine now used as a cancer treatment, which is so cheap to manufacture that a company in Brazil sells it for pennies a pill.”

“Celgene initially spent very little on research and priced each pill in 1998 at $6. As the drug’s popularity against cancer grew, the company raised the price 30-fold to about $180 per pill, or $66,000 per year. The price increases reflected the medicine’s value, company executives said.”

“In 2005, the company introduced Revlimid, a derivative of thalidomide that is supposed to be less toxic, but may be no more effective. Celgene priced it at about $260 per pill, or $94,000 per year.”

It’s truly your money or your life. Is that what the company executive meant by value? Gold at 800/ounce is cheap compared to these agents.

Drug manufacturing is the new alchemy with the irony being that many of the newer agents are only marginally better than previous treatments. They are undoubtedly an improvement but is the cost/unit improvement worth bankrupting the health care system.

We need patent reform and aggressive negotiations with drug manufacturers to curb excessive pricing. (See this for proposals) There is legislation that requires reasonable pricing for government research funded advances that has never been applied. And lastly we should have an organization like NICE that objectively evaluates new advances, costly or not, and provides guidelines for payment and their use.

The question is whether the new administration has really isolated itself from Big Pharma’s influence. We’ll see soon enough.

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Cancer Incidence decreases, Survival Improves

It’s wonderful to see benefits of public health interventions reflected in cancer statistics and outcomes.

“Cancer diagnosis rates decreased by an average of 0.8 percent each year from 1999 to 2005”

“The data may point to a real decline in the occurrence of some types of cancer, experts said. Alternatively, the decline may reflect inconsistent screening practices, causing some cancers that used to be detected to now go undiagnosed.”

“Breast Cancer incidence rates decreased by 2.2 percent annually from 1999 to 2005” Medicynical note: likely due to decrease in use of estrogen hormone replacement.

“The incidence of prostate cancer declined by 4.4 percent a year from 2001 to 2005, after annual increases of 2.1 percent a year for several years” Medicynical note: This may be a screening artifact.

“The incidence of lung cancer has been declining among men for many years but rising among women, though the increase is slowing, according to the report.”

“Women, unfortunately, got hooked on the smoking habit in the ’60s and ’70s,” Dr. Eheman said, “so there was a larger increase in smoking later on in time, and the prevention of smoking has been slower. The decrease in lung cancer that we hope will occur has not been happening yet.” Medicynical Note: The decline in lung cancer is almost certainly due to smoking cessation programs which seem to have been more effective amongst men than women.

There was a decline in death rates as well:

“Death rates from cancer fell an average of 1.8 percent each year from 2002 to 2005, according to the new report. Although last year’s report said death rates dropped an average of 2.1 percent each year from 2002 to 2004, a modest 1 percent decline in 2005 lowered the average percentage for the period.” Medicynical note: This death rate decline is almost entirely due to improved disease screening and early diagnosis. The earlier the diagnosis the better the outcome.

However, PSA testing has problems with both sensitivity and specificity. Colon cancer screening seems best done with colonoscopy which is labor intensive and very costly. To further improve we’ll need to develop screening technology that’s less costly more sensitive and more specific.

Treatment may contribute to the improvement but it’s benefit is small, and an order of magnitude more expensive than the prevention and early diagnosis strategy.

Other articles reporting these findings in the media point out the decline in government research funding over the past several years and make a plea for more government spending on medical research.

Medicynic certainly supports such funding but would point out that it’s been common practice to allow patenting of government funded research for the benefit of private companies, individual researchers, and research institutions. These patents allow monopoly pricing of medical advances for a generation. Such misuse of public funds needs to be stopped either by not allowing patenting of government funded advances which would encourage more active price competition and/or enforcing the reasonably pricing provision of Dole-Bayh legislation which facilitated the patenting of government sponsored advances.

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