4 ms·

That is a very biased view of the situation. Pharma companies try to put the best face on data to get a drug approved. Analysts try to approach the data in an

That is a very biased view of the situation. Pharma companies try to put the best face on data to get a drug approved. Analysts try to approach the data in an impartial way. If an analyst looks at the data and sees issues, it makes sense both ethically and financially to push for the drug not to be approved. Ethically, if the drug doesn't work as advertised, it is better that it is not sold as a cure. Informing the FDA of your analysis is a duty. Financially, if you think the drug doesn't work, it makes sense to short the stock in the belief that it won't be approved. Pharma companies always present it as hedge funds trying to kill their products, but if the data is strong and the drug works, the analyst could just go long on the company instead.

kragen 11y ago
Yes, it makes sense ethically to push the FDA not to approve a drug you think won't work. It also makes sense financially to bet that the FDA won't approve a drug that you think won't work. But it doesn't make sense ethically to do both, both directly because it creates a conflict of interest, and indirectly because that very conflict of interest undermines both the objectivity and the credibility of your recommendation not to approve the drug.
- ci5er 11y ago
  You are arguing ... what, here? That people with some sort of knowledge of a product/company/industry's prospects shouldn't be allowed to buy/sell positions in that company? If I understand you (and I may not), and we were to come to the conclusion that "there ought to be a law", I have no idea how that would even be structured/written.
  - kragen 11y ago
    Yes, I think you are correct that you did not understand me. I'm sorry.
    - ci5er 11y ago
      Please don't apologize - I'm apparently the one with reading comprehension issues.
anthony_d 11y ago
I don't think your view of the situation is any less biased. The problem is that there is very little incentive to ever reject a drug. Shorting is the only case I can think of and even that assumes the drug in question is important enough to actually move share price. Remember the FDA is primarily concerned with a drug not harming people, the extent to which it's actually beneficial is of secondary interest at best: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugs...
- cowsandmilk 11y ago
  > Remember the FDA is primarily concerned with a drug not harming people, the extent to which it's actually beneficial is of secondary interest at best Uh... no. Just from that page, it states the FDA ensures "that drugs and devices are safe and effective for their intended uses". If safety was the only concern: 1) Why does the FDA approve indications? 2) Why has there been prosecution (possibly violating the first amendment) for promotion of off-label uses? 3) Why does the FDA have a "breakthrough" designation that fast tracks approvals solely based on their effectiveness? 4) Why do Pharma companies frequently run new trials using different end points in an effort to get a drug approved when the original end points they used showed no effect? Why have there been cases when the FDA didn't approve a drug because they declared the end point used in the clinical trials was meaningless for the indication? I think it is fairly clear that a shitload of time and resources at the FDA are spent deciding whether drugs are effective and if the data from the pharmaceutical company shows effectiveness. Edit: I should also add the whole DESI review[1] in the 1960's shows your statement is complete nonsense. Drugs that the FDA previously approved for safety before 1962 were re-analyzed to classify their efficacy. So, the FDA reanalyzed thousands of drugs they had already determined were safe to look at whether they were effective. [1] https://en.wikipedia.org/wiki/Drug_Efficacy_Study_Implementation https://en.wikipedia.org/wiki/Drug_Efficacy_Study_Implementa...
  - anthony_d 11y ago
    From the entire page you found the one case where the word "effective" is used and it's used after the word "safe". Here's what the page says about new drug applications: The IND application must contain information in three broad areas: * Animal Pharmacology and Toxicology Studies - It must be reasonably safe. * Manufacturing Information - The company can make consistent batches of the drug. * Clinical Protocols and Investigator Information - Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. The 3 requirements around the new drug application are all safety based. Later on they look at efficacy, but it's later in the process. Efficacy doesn't mean it has to be very effective just somewhat. Read the references for your Wiki page, the FDA is concerned with removing harmful drugs.
FireBeyond 11y ago
Given the multiple issues Martin has faced over the years, I think it's fair to say that 'impartiality' is the least of his motivations. "If an analyst looks at the data and sees issues" - what are they? A stockbroker, or pharmaceutical scientist? How many are both? It would only make financial sense to push for the drug not to be approved -if- you had a position that made a gain from that, but let's not pretend like Martin was doing so out of any source of ethics.
- cowsandmilk 11y ago
  I don't care about Shkreli, I care about whether the practice is ethical. There are plenty of pharma analysts who have used the same techniques who have medical degrees, have worked on clinical trial design at pharma companies, etc. They often aren't the names you see when pharma complains about people shorting their stocks because pharma only wants to point at the head of the hedge fund who has no life sciences expertise. They don't want the public to know about the dozen experts the hedge fund manager is paying to analyze the filings in order to challenge the filings and decide whether to short the stock. No one complains if your analysis shows the molecule is great and you go long, it only becomes evil if your analysis shows the molecule is crap.
  - FireBeyond 11y ago
    And if pharma analysts who have medical degrees want to analyze filings from these companies, great. But the specific example is talking about Martin Shkreli doing this - a man whose formal education is a Bachelor of Business from CUNY. And ethics have roots in motivations. Shkreli couldn't give two hoots whether the drugs had efficacy or not. He wanted them to fail approval only because of his position in the companies.

kragen 11y ago

Yes, it makes sense ethically to push the FDA not to approve a drug you think won't work. It also makes sense financially to bet that the FDA won't approve a drug that you think won't work. But it doesn't make sense ethically to do both, both directly because it creates a conflict of interest, and indirectly because that very conflict of interest undermines both the objectivity and the credibility of your recommendation not to approve the drug.

ci5er 11y ago
You are arguing ... what, here? That people with some sort of knowledge of a product/company/industry's prospects shouldn't be allowed to buy/sell positions in that company? If I understand you (and I may not), and we were to come to the conclusion that "there ought to be a law", I have no idea how that would even be structured/written.
- kragen 11y ago
  Yes, I think you are correct that you did not understand me. I'm sorry.
  - ci5er 11y ago
    Please don't apologize - I'm apparently the one with reading comprehension issues.

anthony_d 11y ago

I don't think your view of the situation is any less biased. The problem is that there is very little incentive to ever reject a drug. Shorting is the only case I can think of and even that assumes the drug in question is important enough to actually move share price. Remember the FDA is primarily concerned with a drug not harming people, the extent to which it's actually beneficial is of secondary interest at best: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugs...

cowsandmilk 11y ago
> Remember the FDA is primarily concerned with a drug not harming people, the extent to which it's actually beneficial is of secondary interest at best Uh... no. Just from that page, it states the FDA ensures "that drugs and devices are safe and effective for their intended uses". If safety was the only concern: 1) Why does the FDA approve indications? 2) Why has there been prosecution (possibly violating the first amendment) for promotion of off-label uses? 3) Why does the FDA have a "breakthrough" designation that fast tracks approvals solely based on their effectiveness? 4) Why do Pharma companies frequently run new trials using different end points in an effort to get a drug approved when the original end points they used showed no effect? Why have there been cases when the FDA didn't approve a drug because they declared the end point used in the clinical trials was meaningless for the indication? I think it is fairly clear that a shitload of time and resources at the FDA are spent deciding whether drugs are effective and if the data from the pharmaceutical company shows effectiveness. Edit: I should also add the whole DESI review[1] in the 1960's shows your statement is complete nonsense. Drugs that the FDA previously approved for safety before 1962 were re-analyzed to classify their efficacy. So, the FDA reanalyzed thousands of drugs they had already determined were safe to look at whether they were effective. [1] https://en.wikipedia.org/wiki/Drug_Efficacy_Study_Implementation https://en.wikipedia.org/wiki/Drug_Efficacy_Study_Implementa...
- anthony_d 11y ago
  From the entire page you found the one case where the word "effective" is used and it's used after the word "safe". Here's what the page says about new drug applications: The IND application must contain information in three broad areas: * Animal Pharmacology and Toxicology Studies - It must be reasonably safe. * Manufacturing Information - The company can make consistent batches of the drug. * Clinical Protocols and Investigator Information - Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. The 3 requirements around the new drug application are all safety based. Later on they look at efficacy, but it's later in the process. Efficacy doesn't mean it has to be very effective just somewhat. Read the references for your Wiki page, the FDA is concerned with removing harmful drugs.

FireBeyond 11y ago

Given the multiple issues Martin has faced over the years, I think it's fair to say that 'impartiality' is the least of his motivations. "If an analyst looks at the data and sees issues" - what are they? A stockbroker, or pharmaceutical scientist? How many are both? It would only make financial sense to push for the drug not to be approved -if- you had a position that made a gain from that, but let's not pretend like Martin was doing so out of any source of ethics.

cowsandmilk 11y ago
I don't care about Shkreli, I care about whether the practice is ethical. There are plenty of pharma analysts who have used the same techniques who have medical degrees, have worked on clinical trial design at pharma companies, etc. They often aren't the names you see when pharma complains about people shorting their stocks because pharma only wants to point at the head of the hedge fund who has no life sciences expertise. They don't want the public to know about the dozen experts the hedge fund manager is paying to analyze the filings in order to challenge the filings and decide whether to short the stock. No one complains if your analysis shows the molecule is great and you go long, it only becomes evil if your analysis shows the molecule is crap.
- FireBeyond 11y ago
  And if pharma analysts who have medical degrees want to analyze filings from these companies, great. But the specific example is talking about Martin Shkreli doing this - a man whose formal education is a Bachelor of Business from CUNY. And ethics have roots in motivations. Shkreli couldn't give two hoots whether the drugs had efficacy or not. He wanted them to fail approval only because of his position in the companies.