Big Pharma lobbies against faster drug trials

Communist China

http://www.forbes.com/sites/aroy/2012/0 … cial-gain/

A bit of a read, but a great example of why I think the Occupy movement and the PPACA are bad trends for the country. Strong regulation means only big firms can play a role, and then it's too easy to stay rich just by preventing others from getting to market. You can't force the companies to care about people just by making them more public. The police still ignore, abuse, and kill the poor after all.

As a result of this inertia, medicine’s innovators in the biotechnology have mostly opted out of addressing these large, common disorders, leaving them in the hands of the lumbering R&D giants like GlaxoSmithKline and Pfizer. Instead, increasingly, the upstart biotechs are focusing on more specialized diseases, like rare cancers, where they can conduct inexpensive clinical trials, and gain approval after mid-stage phase II studies, using what’s known as the accelerated approval process.
The accelerated approval process, instituted in 1992 at the behest of AIDS activists, gives the FDA a mechanism to tentatively approve drugs after phase II if a drug shows promise in a serious disease using a surrogate endpoint...
The problem with the accelerated approval process is that it is only used in very narrow areas, such as cancer and AIDS, where the FDA has to its satisfaction established surrogate markers that it believes to correlate to broader clinical outcomes (such as tumor shrinkage being a surrogate for cancer survival). But there are a lot of areas where surrogate markers aren’t as easy to define. In addition, the FDA focuses on using the accelerated approval process to address life-threatening diseases like cancer, neglecting serious but more chronic ailments such as diabetes, where the cost of clinical trials is prohibitive.
While this problem has harmed patients by making it harder for them to gain access to new treatments, it’s been great for the big pharmaceutical companies. As my colleague Matthew Herper recently showed, from 1997 to 2011, twelve multinational pharma companies spent $802 billion to gain approval for just 139 drugs: a staggering $5.8 billion per drug. While these companies have been remarkably unproductive on the R&D front, they do have one huge advantage: they generate billions of cash from their already-approved drugs, a luxury that smaller biotech companies don’t have.
As a result, the small biotechs are forced to partner with the big pharma companies to get their drugs to market. The biotechs are forced to give up the economic upside of success for their innovations, while big pharma skims the cream off of biotech pipelines for their own purposes.
Sen. Kay Hagan (D., N.C.) is attempting to do something to address this problem. Today, she is introducing a bill called the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act, which seeks, among other things, to incrementally the accelerated approval process.
But what you didn’t hear from Sen. Hagan today is what happened behind the scenes. It turns out that big pharma helped to kill an earlier version of the TREAT Act, which would have created an entirely new “progressive and exceptional approval” pathway for innovative new drugs: something that could have turbocharged drug development in several fields.
The new pathway would have addressed a much broader range of drugs than the existing accelerated approval process, such as: the first drug approved for a specific and identifiable disease subpopulation; patients unresponsive to, or intolerant of, existing treatments; improvement in patient outcomes due to either improved safety or efficacy; or “otherwise satisfy an unmet medical need.”
Unlike the accelerated approval process, which requires an FDA-sanctioned surrogate marker, the new process would involve a case-by-case negotiation between the industry sponsor and the FDA, in which both sides could come to an agreement as to what would demonstrate an early signal of clinical benefit. If confirmatory phase III studies didn’t reproduce that benefit, the FDA could revoke its approval, as with the Avastin case.
Sen. Hagan’s proposal would have been devastating to the big pharma R&D oligopoly. If small biotech companies could get their drugs tentatively approved after inexpensive phase II studies, they would have far less need to partner those drugs with big pharma. They could keep the upside themselves and attract far more interest from investors. Big pharma, on the other hand, would be without its largest source for innovative new medicines: the small biotech farm team.
Hence, big pharma, through its trade association PhRMA, objected to Sen. Hagan’s proposal, instead arguing for window-dressing reforms to the existing accelerated approval process. Instead of allowing for phase II data to achieve approval for a wide range of drugs, the new TREAT Act merely allows for the existing, surrogate marker-driven accelerated approval process to address “highly targeted therapies for distinct subpopulations.” Relative to the bold, innovative proposal contained in the bill’s original version, the new version amounts to window dressing.

So a government failure (regulation too severely restricting access to medication and hampering innovation) leads to new regulations, which succumbs in committee to regulatory capture by the powerful interests clinging to the status quo. What was the original market failure that brought the US into regulating drug trials? I know FDA is 1906 and DHHS is the early 50s but was it really the case in the late 19th century that drug testing was so poor that this framework was better?

If society was a car, I'd say the government is the brake system and free markets are the gas pedal. If you want change, don't hit the brakes!

Axlin16

That's ONE case though. And I think alot of diehard Republican/conservative idelogies loose that.

In the case of drug regulation, yes it's entirely too regulated. But at the same time drug firms push for those same governments to regulate the product so they can control the market, distribution, use, and cost of the product in order to make as much money as possible. Classic supply and demand theories you learned in the 7th grade.

So it's give and take. In this case I think you take the pressure off just cause.

But in alot of other cases the governement should have an almost Nationalized format over business in order to properly direct it's purpose where business/corporations have proven time and again they cannot be trusted under those particular circumstances.

polluxlm

That's all well and good CC, but when both the people and the super capitalists want socialism, what are you going to do about it?

Being right is one thing, but as long as the super rich continue to fund regulation and planned economy there is not much we can do about it. They've won, now you gotta adapt to their way of doing things. If not, they might soon consider you a threat.

misterID

I know CC is going to hate me for this...

But the medical industry and pharmaceutical companies should not be exempt from any rules concerning profits and administrative costs. There need to be caps placed, along with stricter regulations on malpractice suits, which drive up the insurance doctors have to pay, where the costs are past along to us. I think we need to define gross negligence, which is approaching ambulance chasing levels now in the medical industry. There is abuse there.

Free markets are not the end all be all. Basically letting them operate to their own devices would be epically disasterous.

Check this out... Please humor me here:

"
Healthcare Spending
The total global expenditure for health is now more than US$4.7 trillion a year, according to the World Health Organization, and health expenditure as a percentage of GDP has been increasing among all major economies.

Spending on healthcare varies widely from country to country, as do outcomes. Nor is there necessarily a correlation between the amount of money spent and the effectiveness of the healthcare system. The United States spends more on healthcare than any other country, in both relative and absolute terms, yet its healthcare system scores poorly in terms of its overall performance, according to the Commonwealth Fund Commission, a US private foundation that supports independent research on healthcare issues. The Fund produced a report on the performance of the US health system in 2008 (The National Scorecard on US Health System Performance, 2008). The scorecard aimed to measure and monitor healthcare outcomes, quality, access, efficiency, and equity in the United States. It ranked the United States last out of 19 countries on a measure of mortality amenable to medical care.

This poor performance may reflect the nature of healthcare provision in the United States. The country has several types of privately and publicly funded insurance plans that provide healthcare services. However, the private sector dominates healthcare and the United States is the “only wealthy, industrialized nation that does not ensure that all citizens have coverage” (that is, some kind of insurance), according to the Institute of Medicine, a non-profit organization for science-based advice on matters of biomedical science, medicine, and health.

By contrast, a publicly funded healthcare system, the NHS, dominates healthcare in the United Kingdom, accounting for more than 80% of healthcare spending in the country. Founded in 1948, it aims to provide a free, comprehensive healthcare service, with delivery at the point of need, regardless of the ability to pay. It is the world’s largest publicly funded health service, and claims it is also “one of the most efficient, most egalitarian, and most comprehensive.” Yet it has many critics, who argue that it is inefficient and overly bureaucratic.

Other countries fund their health services in a variety of ways. According to Key Note Ltd, a UK-based market-research company, the Netherlands operates a national insurance market for its 16 million residents. Plans may operate on a for-profit or non-profit basis. The insurance market is highly concentrated, with the top five plans accounting for 82% of enrolment. Plans typically offer coverage in all areas of the country and include all providers, although selective contracting is allowed. Children are covered in full through public funds. Premiums charged for adults represent 50% of the expected annual costs. By contrast, according to Key Note, the Swiss insurance system, which covers 7.5 million people, is highly decentralized. Only non-profit insurers may participate in the scheme, and Swiss premiums vary widely according to the health risks of insured pools across the country, and within regions.

Table 1. Total healthcare spending as a percentage of GDP, 2007. (Source: OECD, www.irdes.fr/EcoSante/DownLoad/OECDHealthData_FrequentlyRequestedData.xls)

Country
Healthcare spending, % of GDP

Australia
8.9

Canada
10.1

France
11.0

Germany
10.4

Italy
8.7

Ireland
7.6

Japan
8.1*

Portugal
10.2*

Spain
8.5

Sweden
9.1

Switzerland
10.8 (est.)

United Kingdom
8.4

United States
16.0

* 2006 data; est.: estimate

Japan spends around 8.1% of its GDP on healthcare, almost half the amount of the United States. Yet the Japanese have the longest healthy life expectancy on the planet. Diet and lifestyle clearly play a key role, but the country’s universal healthcare system may also be an important factor. Everyone in Japan is required to take out a health-insurance policy, either at work or through a community-based insurer, according to Key Note. The firm adds: “The government pays for those who are too poor. However, 80% of Japan’s hospitals are privately owned—more than in the US—and almost every doctor’s office is a private business. The Japanese Health Ministry tightly controls the price of healthcare, down to the smallest detail. Every two years, the healthcare industry and the health ministry negotiate a fixed price for every procedure and every drug.”"

Axlin16

Fantastic post that once again proves to those that just do not get Socialism. It's not anti-Capitalist. It's just as much pro-Capitalist, if not more so. Because of business does well, then the people do well.

This is a lost concept on Americans, because they have no clue how the world actually works outside of the country, simply because they believe what their politicians (almost all businessmen) tell them as to how the system works.

It just doesn't. You've got actual American research firms, as well as international research firms showing constantly accurate numbers that prove fiscal conservative ideas wrong constantly, yet their response? "They have an agenda".

After awhile you realize that there are certain people who don't want the real numbers. They don't want the real facts. They want to hold on to their ideas like it's a religion. It cannot under any circumstances be disproven.

It's a real shame.

There are numerous people in America, i'd go so far to say millions, who were anti-universal health care because Republicans and insurance companies spread a vicious falsehood that universal health care would give the President the right to "pull the plug on the elderly, if they couldn't pay".

Not only does that not make ANY sense in regards to the U.S. concept for universal health care, it actually had protections to safeguard against just that event.

The only thing that can be said sadly is that alot of the American electorate are lazy, poorly educated, and small-minded.

As the old saying goes, "A Democracy is as good as the people who elect it". That statement almost never has anything to do with a President (whether Bush or Obama), but far far FAR more to do with Congress and the House which are the real sandbags to progress to the future in the U.S.

Communist China

Axlin, take a serious look at yourself. I'm not going after your politics, but the way you behave in these threads is insulting. You say I'm wrong and that people who are on "my side" of this issue actively ignore objective analysis. You don't cite your objective sources, you don't bring your information to the table, you don't engage in a serious discourse. You're completely close-minded, and worse, rude.

You seem like an intelligent guy, so I assume you recognize the immense difficulty in measuring the impacts of large social policies objectively. Even CBO projections are usually way off. It's disingenuous to claim objective scientific calculation rests on your side and yours alone. And it's really fucking disrespectful to assume I'm not interested in the information that you have. Your refusal to engage in debate doesn't make you "above" us or more enlightened, it just shows how close-minded and afraid to risk yourself you are.

As for misterID, that info doesn't cause me any stress. You can't blame the free market for the problems in health care because we don't have a free market in health care. Look at what I posted again - that sort of system, which I'm deriding, would absolutely give you higher health care spending per capita. It's grossly inefficient by tying medical progress to the financial giants capable of getting through the FDA process. So yeah there's mountains of waste. Scaling back the government's role would drastically cut our health care costs. Socialized systems sometimes look more cost-effective but they inevitably have to restrict people's right to eat what they want or smoke what they want. I want lower health care costs without sacrificing innovation or the right to use my body as I see fit.

Think about the issue in the article I posted - isn't that a problem in our system? Why has our knowledge of biology doubled multiple times in the last few decades, but the rate of new drugs being released is slowing down? It's not the free market slowing that down. Why has such a huge percentage of the innovation in medical technology been in testing for relatively rare conditions and not better care techniques for common ills? The Medicare system has a "you invent a treatment for it, we'll cover it" policy that leaves us with all this expensive stuff we don't need instead of better drugs and cheaper therapies for common illnesses. THIS is the impact of government involvement in medicine - some people get a temporarily better service than they otherwise could've had, but overall progress in the field is retarded while prices rise and rise. The CBO says PPACA will "save" money, but much like the claims that GM has repaid or is repaying the taxpayers, it relies on a lot of financial trickery that would make Wall Street envious (maybe because Wall Street's best people run the government). I'll be happy to cite either of those, but it shouldn't surprise anyone that the CBO's projections are always cost-conservative given Congress' mandates about what they're allowed to predict (spending cuts! Bush tax cuts expiring!) and what they know will actually happen (neither of those!).

If socialism is pro-capitalist I want no part of either. I want free markets, free minds, and free people. I recognize the practical limitations on all 3 things, but they're worth pursuing.

misterID

CC, if we got what you want the prices would be even more out of control and fewer and fewer people would be able to afford health care. Why should we give these companies ALL the power when other countries are doing it better. The people you want to hand ALL the power over to are the ones rigging the system. If you took out the goverment it would be worse. It's worse than OPEC right now. You're asking me to think about your side, but you're ignoring the fact that other countries are doing it better without putting it in the hands of free markets.

If it weren't for Medicare my father's insurance would cost him $3,000 a month. That is ridiculous.

Are you seriously okay with people dying specifically for the sole reason that they can't afford healthcare?

There are just more important things than a corportions right to make as much money as they possibly can, anyway they can. Capitalism, in itself, is unstable and unpredictable and easily manipulated. As US history has shown, it's best with using some socialist elements.

Axlin16

Communist China wrote:

Axlin, take a serious look at yourself. I'm not going after your politics, but the way you behave in these threads is insulting. You say I'm wrong and that people who are on "my side" of this issue actively ignore objective analysis. You don't cite your objective sources, you don't bring your information to the table, you don't engage in a serious discourse. You're completely close-minded, and worse, rude.
You seem like an intelligent guy, so I assume you recognize the immense difficulty in measuring the impacts of large social policies objectively. Even CBO projections are usually way off. It's disingenuous to claim objective scientific calculation rests on your side and yours alone. And it's really fucking disrespectful to assume I'm not interested in the information that you have. Your refusal to engage in debate doesn't make you "above" us or more enlightened, it just shows how close-minded and afraid to risk yourself you are.
As for misterID, that info doesn't cause me any stress. You can't blame the free market for the problems in health care because we don't have a free market in health care. Look at what I posted again - that sort of system, which I'm deriding, would absolutely give you higher health care spending per capita. It's grossly inefficient by tying medical progress to the financial giants capable of getting through the FDA process. So yeah there's mountains of waste. Scaling back the government's role would drastically cut our health care costs. Socialized systems sometimes look more cost-effective but they inevitably have to restrict people's right to eat what they want or smoke what they want. I want lower health care costs without sacrificing innovation or the right to use my body as I see fit.
Think about the issue in the article I posted - isn't that a problem in our system? Why has our knowledge of biology doubled multiple times in the last few decades, but the rate of new drugs being released is slowing down? It's not the free market slowing that down. Why has such a huge percentage of the innovation in medical technology been in testing for relatively rare conditions and not better care techniques for common ills? The Medicare system has a "you invent a treatment for it, we'll cover it" policy that leaves us with all this expensive stuff we don't need instead of better drugs and cheaper therapies for common illnesses. THIS is the impact of government involvement in medicine - some people get a temporarily better service than they otherwise could've had, but overall progress in the field is retarded while prices rise and rise. The CBO says PPACA will "save" money, but much like the claims that GM has repaid or is repaying the taxpayers, it relies on a lot of financial trickery that would make Wall Street envious (maybe because Wall Street's best people run the government). I'll be happy to cite either of those, but it shouldn't surprise anyone that the CBO's projections are always cost-conservative given Congress' mandates about what they're allowed to predict (spending cuts! Bush tax cuts expiring!) and what they know will actually happen (neither of those!).
If socialism is pro-capitalist I want no part of either. I want free markets, free minds, and free people. I recognize the practical limitations on all 3 things, but they're worth pursuing.

I don't bring my objective analysis to these threads because I save it for the people worth bringing it to.

You are one of several people here that already have their minds made up.

This isn't a debate. This is a discussion which I had my say.

Normally with these threads i've already got my guns ready and my sources ready to go, and usually misterID beats me to the punch.

But frankly dude, YOU are the one being rude.

I spend way too much time on this board as it is, and I spend alot of time adding to the GN'R section, as well as the MLB News thread. ALOT of time, compared to my life, in an almost blog sort of way.

So forgive me if I don't want to spend even more time on baseless, lifeless, boring politics that are frankly clear as day, which some people refuse to see.

It's amazing for how rude I am, that when Randall basically insulted me and every other American on this board, you nowhere to be found. Not shocking. Because you agreed with him.

Communist China

misterID wrote:

CC, if we got what you want the prices would be even more out of control and fewer and fewer people would be able to afford health care. Why should we give these companies ALL the power when other countries are doing it better. The people you want to hand ALL the power over to are the ones rigging the system. If you took out the goverment it would be worse. It's worse than OPEC right now. You're asking me to think about your side, but you're ignoring the fact that other countries are doing it better without putting it in the hands of free markets.
If it weren't for Medicare my father's insurance would cost him $3,000 a month. That is ridiculous.
Are you seriously okay with people dying specifically for the sole reason that they can't afford healthcare?
There are just more important things than a corportions right to make as much money as they possibly can, anyway they can. Capitalism, in itself, is unstable and unpredictable and easily manipulated. As US history has shown, it's best with using some socialist elements.

Your policies are the ones giving these companies power, not mine. My system forces them to make all of their money via voluntary exchange - people choosing to buy their service. Your system has given insurance companies the legal right to mandate that we buy their service. Isn't it obvious which one is really "giving them all the power"? That whole article was about how the regulatory framework discriminates against new firms, giving existing, large corporations with political access a HUGE competitive advantage. By forcing us to go through these businesses, we're subsidizing their waste. By Medicare being willing to cover any procedure or test the biotech industry invents, we're subsidizing waste.

You say other countries are doing it "better" with socialized care and in fits and starts that's true, although being from Buffalo I know how prevalent it is for Canadians to cross the border to get faster care. I've already said that the trade-offs in other walks of life - regulating diets, individual smoking or drinking habits, etc. - are unacceptable to me. And the cultural variations in lifestyle can't be underestimated. US education and gun policy is similarly tough to gauge by international comparison because of the unique heterogeneity of the US and the cultural reverence for guns and vigilante justice, respectively.

Free market health care would reduce the price of doctor visits and drugs and would also result in their being more medical personnel. That is undeniable, unless you think the Socialists won the Calculation debate of the 20s and 30s.

misterID

It wouldn't lower anything. What you want would allow the companies to totally monopolize the industry even more than they already have and set whatever prices they want. Without government oversight there would be no regulation or guidelines to follow and there isn't a single guarantee they would do anything you theorize they would do, and you know this. We should follow the Japanese model.

You want to radically alter the government. Every problem you have can be fixed, but you don't want them fixed, you want it eliminated. That's throwing the baby out with the bathwater.

And again, more people will die only because they can't afford healthcare. Are you okay with that?

Again, I don't want to go back to a pre FDR America.

Re: Big Pharma lobbies against faster drug trials

Re: Big Pharma lobbies against faster drug trials

Re: Big Pharma lobbies against faster drug trials

Re: Big Pharma lobbies against faster drug trials

Re: Big Pharma lobbies against faster drug trials

Re: Big Pharma lobbies against faster drug trials

Re: Big Pharma lobbies against faster drug trials

Re: Big Pharma lobbies against faster drug trials

Re: Big Pharma lobbies against faster drug trials

Re: Big Pharma lobbies against faster drug trials

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