Category Archives: Patents

The AVASTIN Spin Machine: Costs $100,000, little proof of survival benefit, But……..

It’s remarkable how drug companies spin the limited proven benefits of their new drugs.   This in the LA Times:

Avastin can stabilize tumors in ovarian cancer, studies find

Two independent groups working with advanced-stage cases say the drug extended the period before the disease worsened by more than 3.5 months.

At this point there is little data indicating that people with ovarian cancer treated with Avastin (bevacizumab) live longer. 

Medicynical Note:  In the past the end points for a cancer treatment advance was actual proof of shrinkage of tumor masses and a significant survival benefit.  In recent years companies have tried to sell “delay in progression” as proof of benefit.  Often as not however, this “delay”, when found, is not repeatable on follow-up trials and/or there was no observed survival benefit.    That was the case when the FDA deauthorized this same drug’s use in breast cancer because the short delay in progression was not replicated and did not increase breast cancer patients’ length of life.

The problems with Avastin are it’s outrageous price, in the range of $100,000/year and the apparent fact that it is only marginally effective.  This type drug is marketed to desperate patients with life threatening illness and priced way out of proportion to it’s benefit, or even development costs.  It is a fact that most of the early development costs came not from drug companies but rather from taxpayers in the form of research grants.

At a cost to consumers and insurers of nearly $100,000/year, more than practically any other consumer purchase, and just a few months delay in progression–Would you buy a $100,000 car that lasted 3.5 months?–it’s hard to be enthusiastic .

Drug Prices for Indigent Medicare Patients: The Same As Medicaid or Cost plus?

The New England Journal of Medicine (NEJM) (Oct. 12, 2011) looks at the proposal to require drug companies to offer low income Medicare beneficiaries the same prices given Medicaid recipients:

Seems like a reasonable money saving idea but:

Reducing Part D payments for low-income beneficiaries, it is argued, could undermine incentives for the pharmaceutical industry to invest in research and development, as well as create illusory savings by shifting drug costs to other parties. In considering the wisdom of such deficit-reduction proposals, it’s important to consider how well the market is working for Part D and whether there are important inefficiencies that can be eliminated, resulting in budget savings.

It is pointed out however that the market doesn’t seem to work well with the indigent elderly who most often of the medicare group have multiple chronic conditions (30% of the group) and spends more on drugs than others in the medicare group.

It concluded that:

The approach obtains savings without undermining incentives for developing important new medical treatments. The anticipated side effects would be outweighed by the size of the estimated budget gains. This is as close to a win–win solution as we can get.

Medicynical Note: Put pressure on drug companies to offer more affordable drugs, why that may be Un-American. Consider that drug companies spend more on marketing than research; pay nothing to the government for drugs developed from government funded research; all have increased their prices and revenue by incredible amounts during a recession/depression.

Big PHarma will oppose this initiative preferring that we continue to pay more for drugs than any other industrialized country in the world. That’s really Un-American.

Cheaper Generics–An Answer To Patent Abuse

It’s been a long time coming but companies in China and in other emerging economies are finally tiring of the outrageous pricing of drugs by U.S. and other western drug manufacturers. Charging more for a drug, than people earn is not an acceptable business practice in my view. Blackmail would be a more honorable business practice than the drug companies practice of charging more for drugs that might benefit (most don’t have a significant effect) those with serious life threatening illness.

So, it appears drug manufacturers elsewhere are producing these new drugs at a fraction of the cost.

Chinese and Indian drug makers have taken over much of the global trade in medicines and now manufacture more than 80 percent of the active ingredients in drugs sold worldwide. But they had never been able to copy the complex and expensive biotech medicines increasingly used to treat cancer, diabetes and other diseases in rich nations like the United States — until now.

Medicynical Note: 80% of the world market supplied by drugs made in China and India. Amazing.

Big PHarma, Conflicts of Interest, Undue Influence, “Freedom of Speech”

The drug industry does everything it can to influence physician’s and patient’s treatment decisions. They spend more on drug promotion than on drug research. They have innumerable physicians, research and practicing, on their payrolls–by offering grants, honorariae, or simply putting them on salary. And it works, it’s well documented that these conflicts of interest influence physician’s choices of treatment.

So it was not surprising to learn that these companies “data mine,” review records of prescriptions at pharmacies, to learn what doctors are prescribing and where to put their emphasis as they propagandize. What is surprising is the recent Supreme Court decision that it is unconstitutional to limit the right of drug companies access to these confidential records.

Concern about detailing has prompted at least 25 states to consider legislation to curtail it by restricting the transfer and use of physician-identifiable prescribing data.13 Laws passed in 3 states — Vermont, New Hampshire, and Maine — were swiftly challenged by PDIs and a trade association of pharmaceutical manufacturers.14-16 One of these challenges reached the nation’s highest court this year, and on June 23, the Supreme Court struck down Vermont’s statute by a vote of 6 to 3,17 holding that in practical effect, the law unconstitutionally restricted the speech of pharmaceutical companies and PDIs on the basis of the viewpoint it expressed. In this article, we review the Court’s reasoning and examine the implications of its holding.

What’s remarkable is that the Court views this a “freedom of speech” issue, once again elevating corporations to the level of citizenship. (As they did with political contributions)

The NEJM concluded:

The Sorrell decision impedes states’ efforts to curb detailing. Clever lawmakers may, however, be able to write their way around the Court’s ruling. The decision might also offer an unexpected dividend to opponents of data mining: the surrounding publicity might alert physicians to their right to opt out of sharing their prescribing information through the PDRP. Although the Supreme Court swept aside data-mining laws with the stroke of a pen, physicians who object to data sharing can escape it with the click of a mouse.

Medicynical Note: Our single minded Supreme Court appears to value the “citizenship” of corporations over individuals. Money appears to be a form of free speech whether in the form of political contributions or the ability to unduly influence prescribers in our non-system of health care. More American Exceptionalism.

China Better at Capitalism than the U.S. — Controlling Drug Costs

China is making an effort to control drug costs.

A new way to buy essential drugs being tested in Anhui province caused prices to fall by as much as 90 percent. The system, which encourages drugmakers to compete on price and quality for state contracts, may go national and be widened to include other medicines, according to lobbyists representing 38 foreign drugmakers in China.

Foreign companies oppose that because they say it will force them to lower prices to compete with generic-drug makers. That may erode the profit earned from every prescription they sell in the world’s fastest-growing pharmaceutical market, which was worth $41.1 billion last year, according to IMS Health Inc.

Medicynical Note: What a concept, competition. You may recall that when the republican congress passed Medicare Part D, they purposefully refused to consider such type bidding and negotiation. They were, and are, the best congress money can buy.

Drug Shortages: If a drug is inexpensive, Pharma won’t make it!

In the rush to market drugs costing $10,000 to $40,000 with questionable efficacy.  Big Pharma has stopped production of inexpensive effective agents including mainstays of treatment:

But shortages have been reported in many categories of drugs, including antibiotics, and drugs central to the treatment of many cancers, forcing oncologists to delay or alter carefully timed chemotherapy regimens.

Hundreds of drugs are involved.  For example in oncology, cytarabine an inexpensive out of patent drug which is an  essential part of curative regimens for acute leukemia is in short supply.     When needed, hospitals and physicians are forced to search for supplies, and in some instances delay and/or change treatment schedules.  Actions that can adversely affect outcomes.

Medicynical Note: It’s a travesty that health care has become  an income opportunity for industry and providers.  Patient care, access and outcomes (and value) don’t seem to be the primary concern–in this case of the pharmaceutical manufacturing people  What has happened to my profession?

Market Manipulation (Compath)

Campath, a drug used for chronic lymphatic leukemia, has been found to have some activity in multiple sclerosis. The manufacturer, Genzyme Corp., is under pressure of a hostile buyout and is in discussions with Sanofi regarding the liklihood of future profits for this drug, as noted here. In the article the difference in pricing for Campath as a leukemia drug and as a potential MS treatment was noted:

Most MS drugs, such as Biogen Idec Inc’s (BIIB.O) Tysabri, cost more than $40,000 a year. A new oral drug made by Novartis AG (NOVN.VX) called Gilenya costs roughly $50,000 a year.

Campath sells for a fraction of that. As a result, Genzyme has to persuade governments and insurance companies to pay a higher price for the drug as a treatment for multiple sclerosis than it does as a treatment for cancer.

Genzyme says it is confident it can find a way to do it — possibly by withdrawing the drug from the market as a cancer treatment and providing it for nothing.*

Medicynical Note: Drugs costing tens of thousands of dollars per year trade on the desperation of patients with serious illness and are part of reason our health care expenses are soaring. (17% of GDP) From the above it’s clear that Compath was profitable at the lower price charged chronic leukemia patients. Seeing an opportunity to charge more for a larger patient population the company of course does what any for for profit enterprise would do, gouge their customers.

Shouldn’t health care be different? Can such market manipulation be legal, after all these drugs are protected by a government provided monopoly (patents)? Or perhaps should this type government intervention in “free” markets (patent protection) be done away with?

*Addendum: I note on December 22 that the above discussion of pricing has been removed from the Reuters article. Why? Too embarrassing?

However, the quote can be found on the CNBC site here. (and also on other sites by googling the text)