Against Monopoly

defending the right to innovate

Pharmaceutical Patents

Monopoly corrupts. Absolute monopoly corrupts absolutely.

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Making malaria drugs available at low cost

As reported by Newsweek, a much more efficient way to produce artemisinin, which has a 90% cure rate for malaria, has been found by Berkeley chemical engineer Jay Keasling. Interestingly, he has no intention to get rich from it and has also made sure no one else will. The new drug will be marketed in 2010 at cost. Note, though, that he still patented his discovery. A better commitment would have been to let anyone use it.

There are currently large efforts to make malaria prevention and treatment affordable, but unfortunately this is not quite sufficient, as my research with Doug Gollin shows. A larger problem is that prevention is not efficient enough, so that even at minimal costs you still have substantial malarial prevalence and large impacts on economies. Cost reductions like the one Keasling is generating will have an impact on the economic consequences of the disease, but unfortunately not its spread. It may in fact increase it, as people will find it less useful to protect themselves.

A Patent Pool

According to the Guardian there has been a promising development in the area of pharmaceutical patents: GlaxoSmithKline is starting a patent pool for neglected diseases and third world diseases, as well as substantially discounting medicines for the third world. On the one hand the need for a patent pool gives some indication of the R&D gridlock that has been caused by patents. On the other, patent pools have historically(for example in the steel industry) helped break some of the gridlock. (hattip to Ernie Berndt.)

Say no to the merger of drug-makers Wyeth and Pfizer

Steven Pearlstein writes to oppose a proposed merger between drug giants Pfizer and Wyeth link here. His grounds are that the industry has been merging to stay profitable through the establishment of product monopolies rather than competing to produce new and better products. The whole point of drug patents is to foster innovation, so Pearlstein is dead right, though as he implies, rather late in the day after the growth of conglomerates has already sharply reduced competition.

Are the drug companies sick?

Marcia Angell, a Senior Lecturer in Social Medicine at Harvard Medical School writes a review of three books that supports that judgment link here. E.g., when a doctor (a professor at Harvard Med School) is also on the payroll of a drug company, diagnoses a two-year old as bipolar, and is instrumental in the drug's widespread use among the very young, a drug produced by that company, it is hard to conclude anything else.

Four quotes from the review: "Because these psychiatrists were singled out by Senator Grassley, they received a great deal of attention in the press, but similar conflicts of interest pervade medicine. (The senator is now turning his attention to cardiologists.) Indeed, most doctors take money or gifts from drug companies in one way or another. Many are paid consultants, speakers at company-sponsored meetings, ghost-authors of papers written by drug companies or their agents, and ostensible "researchers" whose contribution often consists merely of putting their patients on a drug and transmitting some token information to the company. Still more doctors are recipients of free meals and other out-and-out gifts. In addition, drug companies subsidize most meetings of professional organizations and most of the continuing medical education needed by doctors to maintain their state licenses."

"Many drugs that are assumed to be effective are probably little better than placebos, but there is no way to know because negative results are hidden. One clue was provided six years ago by four researchers who, using the Freedom of Information Act, obtained FDA reviews of every placebo-controlled clinical trial submitted for initial approval of the six most widely used antidepressant drugs approved between 1987 and 1999 Prozac, Paxil, Zoloft, Celexa, Serzone, and Effexor. They found that on average, placebos were 80 percent as effective as the drugs. The difference between drug and placebo was so small that it was unlikely to be of any clinical significance. The results were much the same for all six drugs: all were equally ineffective. But because favorable results were published and unfavorable results buried (in this case, within the FDA), the public and the medical profession believed these drugs were potent antidepressants."

"Conflicts of interest affect more than research. They also directly shape the way medicine is practiced, through their influence on practice guidelines issued by professional and governmental bodies, and through their effects on FDA decisions. A few examples: in a survey of two hundred expert panels that issued practice guidelines, one third of the panel members acknowledged that they had some financial interest in the drugs they considered."

"In recent years, drug companies have perfected a new and highly effective method to expand their markets. Instead of promoting drugs to treat diseases, they have begun to promote diseases to fit their drugs. The strategy is to convince as many people as possible (along with their doctors, of course) that they have medical conditions that require long-term drug treatment."

The enormous profits based on drug patents have now corrupted the doctors as well. A new system, anyone?

Where are the Cures

According to Michael Heller the cures are lost in patent gridlock. His article in Forbes has the not very pretty details.

Pfizer wins and the consumer loses, Big Time

Been here before. The courts have blessed a settlement between Pfizer and Ranbaxy, an Indian generic maker of Lipitor, the anti-cholesterol medicine, in which the generic is kept off the US market for about 20 months link here. The news story suggests the deal may be worth on the order of $10 billion to Pfizer.

In an interesting twist to the story, the deal involved no cash payments which would have been against the law, but Ranbaxy was being allowed to sell its generic in a number of international markets. They include Canada, so smart American buyers can avoid the monopolist's prices by buying there and having the med mailed to them individually in the US.

Lipitor already faced competition from a generic form of Zocor, but Pfizer has apparently been pretty successful in keeping its established customers.

Big Pharma's takedown

Writing in the Washington Post, Melody Petersen reviews OUR DAILY MEDS by Shannon Brown link here. Little in the review is new to readers of this blog, but it is still eyeopening to read the history of Big Pharma. The review's begins, "Once upon a time there was an industry called pharma that was interested in doing well and doing good. Run by doctors and chemists, drug companies employed battalions of researchers whose scientific efforts resulted by mid-century in a flood of life-saving drugs, including antibiotics, vaccines, tranquilizers, antihistamines and steroids. As George Merck, president of the company founded by his father, put it in 1950, "We try never to forget that medicine is for the people. It is not for the profits. The profits follow. . . ."

The review goes on to trace the development of Big Pharma's business model:

Develop or acquire a patented drug;

Forget further R&D as long as sales increase;

Identify a disease, real or imagined, which it treats but preferably doesn't cure for fear of cutting off a lifetime of sales;

Brand it for that condition;

Advertise the hell out of it, as ads are more important to sales than efficacy or developing new drugs;

Develop close competitor drugs to those which are very successful, like the more-than-10 anti-cholestoral drugs;

Ignore drugs for diseases which the rich world doesn't get.

There is more to the story, but that is enough for starters.

Here we have a hugely important and expensive industry that starts out with IP and then twists it to maximize profit. Business school students would regard that as highly innovative, but for the most part, what innovation there is doesn't benefit the consumer. The best I can say for it is that the ads pay for evening television news check them out.

Patently Corrupt

Via Kevin Drum, the excerpt below from a story by Shannon Brownlee in the Washington Post describes how the pharmaceutical industry creates "diseases" in order to increase sales of their patented drugs.

Condition branders use "information" about medical conditions to forge links between disease and treatment in the minds of both patients and doctors. If they have a drug but no condition, they will simply invent a disease.

....One of the best examples is "osteopenia," a diagnosis that millions of women my age are given every year.....Before the 1990s, doctors decided that you had osteoporosis if you were elderly and you broke a bone. When the pharmaceutical company Merck came up with its anti-bone-loss durg Fosamax, it wanted a broader market than just elderly fracture patients. The solution? The company helped fund a panel of medical experts to create diagnostic criteria for osteoporosis so that a diagnosis could be made before the patient actually broke a bone.

The panel's first step was to define "normal" bone density as that of the average 30-year-old woman. Next, the experts chose as their cutoff for osteoporosis a statistical point that was slightly below the bone density of their normal 30-year-old a definition they admitted was "somewhat arbitrary." Finally, they came up with a completely new disease osteopenia for bone density that fell somewhere between that normal 30-year-old and their arbitrary definition of osteoporosis.

Voila 30 percent of post-menopausal women suddenly had a disease that needed to be treated early in order to prevent a problem hip fracture that wouldn't occur for many years, if ever. According to the new guidelines, millions more women now had osteopenia, which their doctors needed to watch like hawks so that their patients could be treated once they progressed to osteoporosis. Merck then took the added step of helping doctors buy DEXA scanners, X-ray machines needed to scan your bones to get that all-important diagnosis.

Monopoly corrupts. Absolute monopoly corrupts absolutely.

"The Ugly Reality of the Pharma Business"

Fred Hassan, boss (can't resist calling the CEO of a drug firm a boss) of troubled drug manufacturer Schering-Plough, is profiled in the Feb. 11 issue of Forbes, "Fix It, Fred".

According to the article, "Schering's case reveals the ugly reality of the pharma business. Lacking genuinely new medicines or definitive proof that their costly, patented drugs work better than cheap ones, producers are forced to turn minor marketing advantages into billion-dollar oppotunities. Hassan's great at this."

Schering had a problem with trial data from a study of arteries in 2006; last year an outside investigator called it "a mess."

Tell it to the cholesterol skeptics.

When Hassan was hired, the problems were so bad he brought in a compliance officer, who hired 100 (count 'em) compliance managers. No wonder they want their patent monopolies.

What's Intellectual Property Got to Do with It?

Gary Taubes, author of the acclaimed book Good Calories, Bad Calories, has a thought-provoking revisionist op-ed in the New York Times, "What's Cholesterol Got to Do with It?", in which he argues that the medical-scientific establishment has gone down a dead end path in developing ill-conceived and ineffective therapeutic agents for heart disease, at least to the extent that it is thought to be caused by "bad" cholesterol.

He points to studies questioning the scientific verity that cholesterol is even a disease-causing factor in the first place. It seems that the medical establishment has focused wrongly on the cholesterol cargo, which is easier for doctors to measure, and overlooked the lipoprotein vehicle, which carries the cholesterol, and which might be the real bad guy.

Meanwhile the drug companies have gotten rich off their patent-protected statin drugs, which might be useless, at least for many people.

My question, not considered by Gary Taubes (there's no reason why he should here), is: to what extent has the patent regime deflected scientific research away from more promising scientific paradigms and research programs on the one hand, and from more effective medicines and alternative treatments on the other? Just in case you can't get enough of this stuff, here's a link to The International Network of Cholesterol Skeptics.

Bon apetit.

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