Category Archives: Patents

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)


Herceptin, Tykurb in Breast Cancer : What wasn’t reported

Tis the season of the San Antonio Breast Conference and the season of overstatements–most often by people with drug company ties.

There was an interesting report on combining Herceptin (trastuzumab) and Tykurb (lapatinib) in Her2neu positive breast cancers.

The report studies neoadjuvant use of targeted treatment in breast cancer. That is, treatment prior to surgery with the goal of shrink tumors, making breast conservation more possible and hopefully improving patient survival.

What wasn’t noted in the report:

1. Neoadjuvant therapy with conventional drugs alone results in drug shrinkage and complete response in about 25% of patients,and improves breast conservation rates, but shows no survival advantage after several years study.
2. Neo adjuvant treatment including Tykurb and Herceptin (the current study) shows shrinkage of tumors and improved ability to do breast conservation surgery. BUT, despite the hooplah, no survival studies have been completed. It is not known whether the drugs actually improve survival.
3. The drugs are only effective when used on the small group, 15-20% of breast cancer patients, who have overexpression of Her 2 neu.
4. The cost of the two drugs in combination is at least $10,000/month, probably more. Added to the other drugs used, doctors fees the cost for this treatment is probably around $20,000/month.

Medicynical Note: I recall a patient of mine who informed me, when told he would have to pay $38/pill for a new anti-nausea drug, that he’d rather throw up than pay that. He seems somewhat prosaic given the current inflation of cancer drug costs.

You better believe that cost is a major issue, particularly in a non-system that is bankrupting us. In what other area of consumer commerce would $20,000/month be spent?

In this study half the patients apparently have little or no response. So let me rephrase the question. In what other area of consumer commerce would $20,000/month be spent on a product which only works half the time (if every one of the responding patients lived longer, which is extremely doubtful). Consider also the impact of 13 months treatment at $20,000/month (4 months pre-surgery and 9 months post), that is $260,000 for drugs alone–not counting the costs for the 50% of patients that don’t respond, a minimum it seems of 4 months of treatment, $80,000.

The issue now and in the future is likely cost. Who will pay? How? A further issue is how can an industry produce and market drugs so inefficiently that costs are so high?

Campath for Multiple Sclerosis — A Primer on Drug Marketing

This from Bnet is enough to make a Medicynic’s day:

If Campath is approved for MS, Genzyme would face several choices, both moral and economic:

It could rebrand Campath as an MS drug and sell it in MS-dose-sized ampules for thousands of dollars more. But that would lead to an uproar from MS sufferers who would know they’re being exploited. And it might lead to doctors splitting up 30mg ampules intended for CLL patients and diverting the supply to MS patients.

It could leave Campath at the same price for CLL — but that would destroy the existing MS drug market and drug companies are generally loathe to implode lucrative disease categories when they present themselves.

It could withdraw the drug completely for CLL but promise to continue supplying those patients free of charge, and then relaunch Campath as an expensive MS-only product. That might prevent MS patients migrating to diverted CLL doses, but it would also be controversial.

Medicynic: How about providing an effective drug at minimal cost

Pharmaceuticals Profitability makes Walmart feel Sick

Compare the revenues and profits of these companies : (Data from Fortune 500 2010)


Medicynical Note: Using profits as a percent of total revenue the pharmaceutical industry may well be the most profitable sector in the Fortune 500. For example, Walmart offers a paltry 3.51% of revenue as profit, Exxon 6.77%, Apple a mere 15.6%. Drug companies and these are not the foreign based big earners garner Johnson and Johnson 19.8%, Pfizer 17.6%, Merck 47.2% and Abbott 19.1%, Lilly 19.8%, Bristol-Meyer Squibb 49.05%.

You gotta feel sorry for the poor drug companies. Guess who pays?


Epogen, Aranesp and Procrit–Tumors grow faster

Epogen and Procrit have been used for about 20 years. They have been shamelessly marketed as an adjuvant to treat fatigue, rather than therapy for cancers. They were promoted as safe and effective.

Now after all these years we learn:

Studies have shown that the drugs, which sell under the trade names Epogen, Aranesp and Procrit, can cause tumors to grow faster and shorten the lives of some cancer patients.

They also:

increase risk of heart failure, blood clots and stroke.

Medicynical note: This is a more profound product liability problem than Toyota’s. Where’s the outrage? Congressional interest?

These drugs accounted for tens of billions of dollars in health care expenses since the early 90′s. The companies aggressively, and I mean aggressively, marketed to consumers as well as physicians. Creating organizations to flog the concept that we needed to address the fatigue in cancer problem. There was a feeling all along that these blood cell stimulators might have an effect on tumor cells as well. Were the studies done early on? No! Who knew what and when?

This is a strong argument for a routine impartial review of drug efficacy rather than leaving it to the undermanned FDA and biased drug companies.


Your Money of Your Life–Herceptin and Breast Cancer

Very strange article in the Atlantic arguing all sides of health/cost debate. Virginia Postrel apparently believes that Heceptin, a costly ($60,000 for a course of treatment) biological drug that is used for breast cancer, saved her life. This despite the fact that at one year after diagnosis it is much too early to declare victory.

She indeed has a bad form of breast cancer, 6 lymph nodes positive. She was told there was a 50% chance of surviving.

The statistics she provides are vague and not well documented in the medical literature. For example she states:

“Adding the biological drug Herceptin, approved by the FDA in 2006 for use in early-stage cancers like mine, could increase my survival odds from a coin flip to 95 percent.”

There is no data to support this contention. Herceptin appears to delay recurrence and probably improves survival but how much is still unclear. 95% is a number that greatly exaggerates the benefit.

The New England Journal article cited by the Atlantic piece reported:

“1694 women assignedto one year of trastuzumab, and 1693 women assigned to observation.We report here the results only of treatment with trastuzumab for one year or observation. At the first planned interim analysis(median follow-up of one year), 347 events (recurrence of breastcancer, contralateral breast cancer, second nonbreast malignantdisease, or death) were observed: 127 events in the trastuzumabgroup and 220 in the observation group. The unadjusted hazardratio for an event in the trastuzumab group, as compared withthe observation group, was 0.54 (95 percent confidence interval,0.43 to 0.67; P<0.0001 by the log-rank test, crossing theinterim analysis boundary), representing an absolute benefitin terms of disease-free survival at two years of 8.4 percentagepoints. Overall survival in the two groups was not significantlydifferent (29 deaths with trastuzumab vs. 37 with observation).”

Not nearly as impressive.

The data Ms Postrel herself provides is that chances of recurrence were 1 in six without Herceptin and 1 in 12 with it after two years. Just to be clear, consider that the 1 in 6 recurrence rate means that 16.6% would recur in the non Herceptin treated group. And 1 in 12 (8.3%) would recur in the treated group.

This is a considerable improvement but an exceptionally costly one. It means that out of 100 people treated 8 or so get a benefit. 84 were not going to recur with or without treatment. And around 8 would recur regardless of the treatment used.

At $60,000/patient for Herceptin, 100 patients treated would cost 6 million dollars to treat. Out of the 100 treated, 8 patients would have an improved outcome, a cost of $750,000/patient who benefits.

This is an unimaginable amount for a health care system to spend and it is no wonder that systems think twice before implementing routine use of Herceptin.

The question is whether any health care system can afford this unless they more carefully select patients.

Medicynical note: Our costly pharmaceutic industry prices drugs for cancer patients an order of magnitude higher than drugs developed for less severe illness. Their development costs are a “trade” secret so one can only guess whether the pricing is justifiable. A medicynical guess is that this is a very profitable cost-plus business and that frugality and efficiency are not in these companyies lexicon. They charge based more on the desperateness of the patient’s situation than by the cost of development or even effectiveness of the drug. For example they spend more on drug promotion and advertising than on research.

These drugs are priced high despite the fact that many of them were financed with public funds. Even very effective drugs that required little clinical testing because of their obvious efficacy (admittedly an unusual occurrence) are priced over $50,000/year.

To give this pricing perspective consider that

  • drug costs are increasing at double the rate of inflation
  • incomes dropped several thousand dollars over the past few years
  • the cost of these single drugs alone exceed the median income of U.S. citizens
  • Medical care has superseded home and auto purchases as the most expensive purchases in a lifetime. Amazing

Ms. Postrel notes that we pay more/capita for drugs than New Zealand but what she doesn’t say is that the U.S. non-system spends twice as much as many industrialized nations on all aspects of care; that the U.S. is the only industrialized nation without some form of national health system; and that our outcomes in cancer are only as good as but not significantly better than many other industrialized nations.

As T.R. Reid noted recently:

“Which, in turn, punctures the most persistent myth of all: that America has “the finest health care” in the world. We don’t. In terms of results, almost all advanced countries have better national health statistics than the United States does. In terms of finance, we force 700,000 Americans into bankruptcy each year because of medical bills. In France, the number of medical bankruptcies is zero. Britain: zero. Japan: zero. Germany: zero.”

For people with cancer it’s truly your money or your life, and sadly most of these treatments in advanced disease do not cure and often don’t even improve patients’ outcomes.

Lastly I certainly hope that Ms. Postrel is cured.

AIDS in Africa–We Have a Problem

It was hoped AIDS in Africa was being managed and controlled. Uganda’s victory lap appears to have been premature. It was the poster child for first ignoring the epidemic and later in managing it but now is in danger of “showing (us) how to lose the fight.”

It appears with the emphasis on treatment, prevention was deemphasized and/or mismanaged–the abstinence approach may well have failed. (not a big surprise) In addition the US is not increasing funding leading to question whether the “full $48 billion authorized by Congress by 2013″ will be provided.

The challenge is enormous. Some 33. 4 million people worldwide have HIV, and under new guidelines by the World Health Organization, the number eligible for treatment has grown to 14 million, dwarfing the 4 million in treatment currently. Another 2.7 million people become infected each year. Those who don’t die first will eventually need to take antiretroviral drugs, a mixture of medications that helps the body suppress the disease and must be taken every day for life. The therapy, which doesn’t cure AIDS but allows people with HIV to live normal lives, means the number of people who need drugs will continue to grow.

One irony is that lifesaving medicine makes the prevention message harder to deliver. That much is clear in Uganda, once a leader in preventing the spread of HIV.

But the biggest distraction from prevention was likely the sudden flood of lifesaving drugs beginning in 2005. Fear of HIV dissipated as memories faded about the disease’s ravages. People gradually increased their number of sexual partners again. “Women are now more scared of getting pregnant than getting AIDS,” says researcher Phoebe Kajubi, who conducted a survey in a poor area of Kampala funded by the AIDS Prevention Research Project at Harvard University.

Medicynical Note: There are unintended consequences of introducing technology. The question is where do we go from here? We need a reinvigorated prevention/education program and less expensive medications. This is a medical emergency and patent holders should cooperate and provide generics to these countries.