A NEW PAGE FOR PHARMA.
I've wandered down this road before, but I'm always confused by conservatives who glance at concerns over pharmaceutical pricing and pronounce that if you took away all pharma's money, they couldn't develop any new drugs. Hah! Game, set, match. To paraphrase Popeye, things is what they is, and that's all that they is.
Economic theory? Meet the system in question. Drug innovation is drying up, and pharma's priorities are increasingly misdirected. As Merrill Goozner, author of The $800 Million Pill, writes, "The financial incentives formed by the stock market force R&D decision-makers to focus most of their attention on developing blockbuster drugs for proven mass markets. Minor aches and pains, allergies, depression, cholesterol management, acid indigestion – the rewards for a successful new entry in one of these categories, whether or not it represents a significant new advance over previous therapies, are measured in the billions of dollars in sales." The result? "Between 1989 and 2000, 58 percent of the 361 new molecular entities (NMEs) approved by the FDA were considered “standard” for review purposes, that is, they did not represent a significant advance over existing therapies. And in the first ten months of 2007, when the FDA approved just 14 NMEs, eight were considered standard – almost the exact same percentage as the earlier era." In other words, they were profit drugs, rather than new drugs.
Put more simply, there's agitation to reform the pharmaceutical market because the current structure isn't working very well. We're not getting optimal bang for our buck, or anything near it. For instance: Many of us who focus on drug pricing focus on patents. As Goozner says, "a series of laws and court rulings have given manufacturers the right to obtain new patents for minor changes in chemical structure, changes in routes of administration, and new uses for old products. These patent extenders provide substantial financial rewards to firms that focus their research attention on extending the marketability of their existing products instead of focusing on the truly new and innovative." That's not a wise set of incentives to lay down in your pharmaceutical market, and it explains why there's growing support for a parallel discovery track focused on prizes, rather than patents; why comparative effectiveness research is a major item on any health wonk's wish list; why many of us want the government to assume the cost for medical trials; and on, and on.
The problems are partly scientific in nature, and while there's more we could do to fund the research, there's not a lot we can do to speed it. But they are also financial in nature, the result of poorly applied economic theory and perverted incentives from ruthless financial markets (making malaria drugs may save lives, but it doesn't do much for profits). There's no economic reason that patents, rather than prizes, need be the sole spur for drug innovation; no obvious benefit to a prescription system with relies as much on former cheerleaders flirting with doctors as medical evidence; no clear advantage for a structure that privileges the development of new drugs over the broad application of older ones (keeping pharma profits high means keeping generics rare). Drying up the industry's profits would, to be sure, make them collapse. But reducing some of their advantages, regulating them in different ways, creating new incentive systems, and forcing different sorts of competition may, indeed, dry up some of their profits, but may also result in a pharmaceutical sector better able to innovate and deliver drugs that the populace needs. There's no reason to believe, and much reason to doubt, that the current set-up is anything approaching optimal.
(Photo used under a Creative Commons license from Flickr user Net Efekt.)
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COMMENTS (14)
But Andrew Sullivan can afford HIS drugs, so all is well in health care land.
Posted by: Jamey | January 30, 2008 2:13 PM
The next step is "bootleg" drugs - pharmaceuticals made by manufacturers that simply ignore all of the patent laws and make the medicine that people need. These are already very common in the Far East and it is just a matter of time before they are going to be popular here (followed by the usual scare tactics propogated by the marketing end of big pharma to warn us about the dangers of bootleg drugs etc etc).
Posted by: chowchowchow | January 30, 2008 2:16 PM
There is the benefit that sometimes minor changes allow companies to have a patent, and thus put financial backing behind drugs that aren't yet FDA approved but the original patent has expired. Getting FDA approval is a huge cost.
Posted by: yoyo | January 30, 2008 2:24 PM
IHMO you are either for or against patents. It seems wrong to me to be for patents for all other industries but not for the drug industry.
BTW drugs are small part of medical spending.
BTW I am against patents.
Posted by: Floccina | January 30, 2008 2:34 PM
Well, the DSM-V is on its way, and that's going to add a host of new disorders that Big Pharma can offer pills to treat. One of them under review is apathy disorder, particularly in relation to the dulling of highs and lows that comes with antidepressant treatment. Yep, someone's going to make a pill -- probably a combo pill -- to treat the way your SSRI makes you feel.
There was a fascinating conversation this month on CBC radio with Christopher Lane, the author of Shyness, which looks at the creation of social anxiety disorder, and the drugs that sprang up to treat it. He mentioned at the end of his interview that there's been a study aimed at getting Seroquel, an anti-psychotic drug prescribed to schizophrenics, approved to treat fear of public speaking.
There's your development cycle: create drugs to deal with how antidepressants make you feel, and get anti-psychotics out of the mental hospital and onto the TV. After all, there's no profit to be made in treating the kind of people who've typically been prescribed Seroquel.
Posted by: pseudonymous in nc | January 30, 2008 2:45 PM
Put more simply, there's agitation to reform the pharmaceutical market because the current structure isn't working very well. We're not getting optimal bang for our buck, or anything near it.
Ezra,
There are a lot of things in health care that don't work well. Under any objective concern over "bang for the buck," reforming the drug industry would not be one of your main concerns. The focus is on the drug industry because that's the easy politics. The real value from reforms would be best spent on reforming medical education, clinical practice of medicine, in-patient and out-patient business practices (your "integration" issue) and preventive medicine. But those issues require taking on doctors and nurses versus profitable corporations. And that just ain't good politics. So instead, we focus on an area that needs improvement (a lot of your specific criticisms and thoughts make sense) but will offer much less impact on our system.
Let's just not pretend that the focus on pharma is about concern for what's best for health care or "bang for the buck." Its about the politics, stupid.
Posted by: wisewon | January 30, 2008 3:09 PM
Ezra,
Putting it a slightly different way-- there are many issues within health care that you could focus on with your blog. You have primarily focused on health systems, current policy proposals and politics of health care-- all relating to macro-level views of health care. Pharma is one of the few areas outside of this that you've covered from time to time (health IT would be the other that I recall).
Its not coincidence. You are being influenced by the politics around you. Be original-- take on a tough, wonkish issue like getting physicians to practice medicine based on what works, not what they "like" or learned 20 years ago. Or the medical establishment's opposition to "cookbook" medicine, even though that is exactly what we need more of. Don't just pick on pharma because its a winning strategy for Democrats so you been exposed to the issue. Do an objective look at the health care system, and if you still believe pharma is an important focus for you, so be it. I just think there are more important issues that aren't getting attention that are more worthy of your time and energy. If you looked at the data, I think you'd agree.
Posted by: wisewon | January 30, 2008 3:18 PM
http://www.phrma.org/files/Prescription%20Medicine%20Spending%20Trends%202006%20FINAL.pdf
The Centers for Medicare and Medicaid Services (CMS) reports that spending on prescription medicines accounted for 10 percent of total national health care
spending in 2004. The remaining 90 percent of all health care spending in the U.S. paid for hospitals, doctors, nursing homes, other health services, and administrative cost. Prescription drugs’ share of spending – which includes the cost of both brand and generic drugs, along with the cost of pharmacies – is not projected to rise to 11 percent until 2015.
As bad as the drugs care is, it is better than just about any other part for the healthcare picture.
Posted by: Anonymous | January 30, 2008 3:38 PM
http://www.phrma.org/files/Prescription%20Medicine%20Spending%20Trends%202006%20FINAL.pdf
The Centers for Medicare and Medicaid Services (CMS) reports that spending on prescription medicines accounted for 10 percent of total national health care
spending in 2004. The remaining 90 percent of all health care spending in the U.S. paid for hospitals, doctors, nursing homes, other health services, and administrative cost. Prescription drugs’ share of spending – which includes the cost of both brand and generic drugs, along with the cost of pharmacies – is not projected to rise to 11 percent until 2015.
As bad as the drugs care is, it is better than just about any other part for the healthcare picture.
Posted by: Floccina | January 30, 2008 3:39 PM
Sorry, but there's no serious reason to think the government would be any better than the market at matching up supply and demand for pharmaceutical drugs than for any other consumer product.
Yes, the government has a legitimate role in basic research and in funding the development of drugs for diseases that mostly afflict the poor. But it has no place picking winners and losers in the general U.S. market.
Posted by: Jason | January 30, 2008 9:11 PM
Wisewon and Floccina make some good points. Drugs do get a disproportionate share of attention compared to their significance in overall health care inflation, although 10-11 percent is understated. That doesn't include drugs sold in doctors offices (most cancer drugs) or hospitals, which are subsumed in their "share" of total health care spending. The true number is probably closer to 15 percent. And, it has been rising faster than any other segment, so does contribute somewhere between a quarter and half of all health care inflation in excess of GDP growth. And in the past two years, when health care inflation has slowed to just barely ahead of GDP growth, drug spending has continued to grow at a faster pace than health care as a whole, largely because of the Medicare drug benefit, which through the alchemy of Bush-era politics, was transformed into a price support system for the drug industry.
That said, Wisewon's comments that cost control has to focus on how medicine is practiced in this country is spot on. And the work of Jack Wennberg and his colleagues at Dartmouth, highlighted in Shannon Brownlee's new book, "Overtreated," is as good a place to start as any. As for reorganizing how physicians practice medicine in this country, I recommend Arnold Relman's (former NEJM editor) overlooked but stunningly impressive "A Second Opinion." He thinks all physicians should be salaried and in group practices. I agree. But how we get from here to there is another question.
Posted by: Merrill | January 30, 2008 10:35 PM
I'd suggest that there are two sides to the coin: cost AND benefit.
The focus here has been primarily on cost. The benefit merits discussion as well. Drugs are only allowed on market after they have demostrated conclusively that the drugs works effectively. The same isn't true for most other things in medicine-- even most medical devices are typically approved with a regulatory loophole that has been exploited on a grand scale that limits the need to prove efficacy. Surgery, treatment paradigms, etc.-- hospitals nor physicians are required to show their practices work. So not surprisingly, the few studies that have tried to determine impact of our health care system on life expectancy, have found that drugs are largely responsible for the gains made in the past 30 years. When you then combine the benefit and cost into one metric for a "bang for the buck" analysis, drugs far and away are the best buy in the system.
As I said upfront: are there things to change for the better in the drug industry? For sure. But the overall focus of reform clearly needs to be on the practice of medicine.
Posted by: wisewon | January 31, 2008 7:11 AM
If what the Drug companies are making isn't what people need, then why should we care if they are overpriced?
Posted by: Dave Justus | January 31, 2008 10:04 AM
The government is already deep into "picking the winners and losers in the general US market". The patent system is just one way...imagine, a government enforced monopoly. No one can compete with you, and the government will arrest anyone who tries. Not bad.
Whether or not patent or copyright protection is a desirable public policy, it is undeniably a huge government intervention in the market. In the case of prescription drugs, patent monopolies raise the average price of protected drugs by more than 200 percent, and in some cases by as much as 5,000 percent. In the case of copyright protection, items like software and recorded music and movies that would otherwise be available at zero cost over the Internet, can instead be sold for hundreds of dollars. Clearly these forms of protection are substantial interventions in the economy.
Patent-protected brand drugs sell for more than three times the price of generic drugs that sell in a free market. This means that the country could save approximately $140 billion a year on its $220 billion annual bill for prescription drugs if the government did not provide patent protection and drugs were instead sold in a competitive market. In addition to raising the price for people who buy drugs, the higher patent protected price makes many people unable to afford drugs. These people either go without certain drugs or use less than their prescribed dosage because of government patent protection. Savings of $140 billion may be small as a percent of total healthcare spending, but it is not small.
Posted by: Mitch | January 31, 2008 1:30 PM