I have a new found respect for Mars, Inc (the chocolate company). I was listening to an interview with Hagen Schroeter, the director of fundamental health and nutrition research, at Mars. About 20 minutes of the interview covered the now famous anti-oxidants in chocolate. This has led to a major increase in sales of chocolate.
Hagen's research discovered that this is BS (sorry to all you chocolate fans that have been using this as an excuse to eat more). The processing of chocolate destroys most of the flavonoids and flavonols. And the digestion and metabolism of the chocolate destroys the rest. So test tube studies find anti-oxidants, but in vitro blood tests find zippo make it through.
Some of Hagen's research focuses on new ways to process the chocolate so more of it gets through.
What makes me respect Mars is that the interview asked Hagen if Mars discourages him from publishing the results. After all, this could really kill all of those extra sales they are getting from the rationalizations of chocolate loving dieters.
But his response was just the opposite. He said that Mars encourages him to publish it. One self-serving (for Mars) hope is that independent scientists will read the research and do their own studies on new processing methods that maintain anti-oxidant levels.
But he insisted that it is more of a fundamental openness of their research policy. I can't attest as to whether this is true or not, but the fact that he was disclosing in a publicly available interview that the anti-oxidant meme is BS was some pretty good evidence.
Thursday, March 14, 2013
Friday, March 8, 2013
Liability and Generic Drug Makers
The Supreme Court is hearing a case that has be really fascinated.
As you might know, generic drug manufacturers are not allowed to make any changes to the drug composition or labeling of the brand names they are genericizing.
So what happens (as in this case) if a patient gets severely hurt by the side effects of a generic drug?
1. Can they sue the generic company for damages? The generic company sold them the drug, but was not allowed by law to do anything about it.
2. Can they sue the original pharma company that designed, tested, and brought the drug through Phase I, II, and III trials? It was their mistake, but the patient has no connection with this company so where is the standing?
3. Can they sue the FDA? The FDA should have made sure that the Phase I, II, and III testing was adequate to catch dangerous side effects. But of course this is not feasible economically or scientifically. There are too many variations in patient behavior and genes, remote side effects that don't show up, etc. The drug approval process would be paralyzed. And the federal government has safe harbor from law suits anyway.
4. Maybe the patient sues the generic and the original pharma. The combination is sort of the entity that is responsible.
5. Maybe they just can't sue anyone. If a company gets a drug through FDA trials and approval, perhaps they should be protected from lawsuits.
Then we can imagine some real obfuscation that should add some corollaries to the law. What if the original pharma company knew about the side effect but suppressed it in their drug application? What if the generic company knew about the side effects and the fact that they were suppressed, but couldn't do anything about it because of the law handcuffing generics from making changes? What if these side effects became known after the FDA had granted approval?
The Supreme Court only has to consider one case this time. But another one of these variations could come up at any time. I hope they are ready.
As you might know, generic drug manufacturers are not allowed to make any changes to the drug composition or labeling of the brand names they are genericizing.
So what happens (as in this case) if a patient gets severely hurt by the side effects of a generic drug?
1. Can they sue the generic company for damages? The generic company sold them the drug, but was not allowed by law to do anything about it.
2. Can they sue the original pharma company that designed, tested, and brought the drug through Phase I, II, and III trials? It was their mistake, but the patient has no connection with this company so where is the standing?
3. Can they sue the FDA? The FDA should have made sure that the Phase I, II, and III testing was adequate to catch dangerous side effects. But of course this is not feasible economically or scientifically. There are too many variations in patient behavior and genes, remote side effects that don't show up, etc. The drug approval process would be paralyzed. And the federal government has safe harbor from law suits anyway.
4. Maybe the patient sues the generic and the original pharma. The combination is sort of the entity that is responsible.
5. Maybe they just can't sue anyone. If a company gets a drug through FDA trials and approval, perhaps they should be protected from lawsuits.
Then we can imagine some real obfuscation that should add some corollaries to the law. What if the original pharma company knew about the side effect but suppressed it in their drug application? What if the generic company knew about the side effects and the fact that they were suppressed, but couldn't do anything about it because of the law handcuffing generics from making changes? What if these side effects became known after the FDA had granted approval?
The Supreme Court only has to consider one case this time. But another one of these variations could come up at any time. I hope they are ready.
International Governance by Proxy
Despite the officious title, this is a really important issue. Here is one of the major challenges we face to get anything done that requires international agreement and/or participation.
There are no sovereignty rights for any international organizations. So unless every single country agrees, the agreement stalls. There are some organizations that can pass policies with less than 100% of the vote, but the countries that vote no can just opt-out. That is what the US does with many of the UN initiatives they don't agree with.
The problem is that when you have 150+ countries involved in the negotiation, there will never be an agreement. There are too many divergent issues and priorities. But if you exclude anyone, you lose the value of unanimous consensus, the validity of the agreement, and in practice the compliance of countries that don't agree.
So my thought is to leverage the brilliance of our Founding Fathers and use a federalist representative model. Here is what I am thinking:
1. Each country votes in a secret ballot open ended format for who they want to represent them in the negotiations. They are free to vote for themselves.
2. The top five vote-getters form the negotiating committee. So the risk of voting for yourself is that unless other countries respect your position, your vote is "wasted." In general, larger and more influential countries will get selected. This is what we want if we hope to get consensus and compliance at the end of the process.
3. There is another worldwide vote for weighting. Every country votes for one of the five committee member countries. The committee negotiates equally, but then when any official votes are taken they are weighted according to this score. It can be some hybrid of GDP, population, or whatever summed for all of the countries that voted for them. For example, if many countries respect Brazil's position on environmental policy, then Brazil will receive many votes (in both rounds) and have a large influence in the final international agreement of the environmental committee. But these same countries can vote for a different country when setting up the international trade committee, the human trafficking committee, or whatever. Moderate and reasonable positions are likely to get on the committee. Extremists won't, but will feel included because they got to vote both for committee membership and for committee weighting.
4. These five countries then negotiate a policy. I used five just because it is enough to represent a variety of positions but not unwieldy. If four or six is better, then so be it.
5. The final negotiated policy becomes the international treaty on the environment or on trade or on whatever. Everyone has previously committed to abide by the result and has participated in the process, so there should be a decent amount of buy-in. Admittedly, North Korea and some other real outliers may never agree, but I don't think any system could handle them.
Because every country gives their proxy to one of the final committee members in the second round, their vote is counted in the final treaty vote. Just not separately.
And because a new committee is formed for each domain (environment, trade . . . ), the major positions will always be represented, extreme positions will be muted, and countries will have a strong incentive to build an international reputation for developing smart positions because this was they get to form the final policy language in domains they care about.
There are no sovereignty rights for any international organizations. So unless every single country agrees, the agreement stalls. There are some organizations that can pass policies with less than 100% of the vote, but the countries that vote no can just opt-out. That is what the US does with many of the UN initiatives they don't agree with.
The problem is that when you have 150+ countries involved in the negotiation, there will never be an agreement. There are too many divergent issues and priorities. But if you exclude anyone, you lose the value of unanimous consensus, the validity of the agreement, and in practice the compliance of countries that don't agree.
So my thought is to leverage the brilliance of our Founding Fathers and use a federalist representative model. Here is what I am thinking:
1. Each country votes in a secret ballot open ended format for who they want to represent them in the negotiations. They are free to vote for themselves.
2. The top five vote-getters form the negotiating committee. So the risk of voting for yourself is that unless other countries respect your position, your vote is "wasted." In general, larger and more influential countries will get selected. This is what we want if we hope to get consensus and compliance at the end of the process.
3. There is another worldwide vote for weighting. Every country votes for one of the five committee member countries. The committee negotiates equally, but then when any official votes are taken they are weighted according to this score. It can be some hybrid of GDP, population, or whatever summed for all of the countries that voted for them. For example, if many countries respect Brazil's position on environmental policy, then Brazil will receive many votes (in both rounds) and have a large influence in the final international agreement of the environmental committee. But these same countries can vote for a different country when setting up the international trade committee, the human trafficking committee, or whatever. Moderate and reasonable positions are likely to get on the committee. Extremists won't, but will feel included because they got to vote both for committee membership and for committee weighting.
4. These five countries then negotiate a policy. I used five just because it is enough to represent a variety of positions but not unwieldy. If four or six is better, then so be it.
5. The final negotiated policy becomes the international treaty on the environment or on trade or on whatever. Everyone has previously committed to abide by the result and has participated in the process, so there should be a decent amount of buy-in. Admittedly, North Korea and some other real outliers may never agree, but I don't think any system could handle them.
Because every country gives their proxy to one of the final committee members in the second round, their vote is counted in the final treaty vote. Just not separately.
And because a new committee is formed for each domain (environment, trade . . . ), the major positions will always be represented, extreme positions will be muted, and countries will have a strong incentive to build an international reputation for developing smart positions because this was they get to form the final policy language in domains they care about.
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