4 ms·

If by reducing regulations we increase drug deaths but also decrease deaths from newly treatable illness, not to speak of the benefits of cheaper drugs, it seem

If by reducing regulations we increase drug deaths but also decrease deaths from newly treatable illness, not to speak of the benefits of cheaper drugs, it seems the calculus can come out against the regulations depending on how the numbers shake out. That is to say, the regulations should be subject to a cost-benefit analysis and only those with a positive ROI should remain in place. At the very least we should be allowing drugs to be sold that have been trialed and approved in other first world markets.

ZenoArrow 9y ago
> " the regulations should be subject to a cost-benefit analysis" Not everything related to pharmaceuticals boils down to a cost-benefit analysis. If companies sell a drug with known side effects, but cover it up to make a profit, that might make business sense to its shareholders, but it's not something that benefits society at large. To give an example, Bayer knowingly sold products that were known to give people hepatitis C and HIV. https://en.wikipedia.org/wiki/Contaminated_haemophilia_blood_products https://en.wikipedia.org/wiki/Contaminated_haemophilia_blood... "Contaminated haemophilia blood products were a serious public health problem in the late 1970s up to 1985. These products caused large numbers of haemophiliacs to become infected with HIV and hepatitis C. The companies involved included Alpha Therapeutic Corporation, Institut Mérieux (which then became Rhone-Poulenc Rorer Inc., and is now part of Sanofi), Bayer Corporation and its Cutter Biological division, Baxter International and its Hyland Pharmaceutical division. Estimates range from 6,000 to 10,000 haemophiliacs in the United States becoming infected with HIV." https://articles.mercola.com/sites/articles/archive/2006/08/05/bayer-sells-aids-infected-drug-banned-in-us-in-europe-asia.aspx https://articles.mercola.com/sites/articles/archive/2006/08/... "Recently unearthed documents show that the drug company Bayer sold millions of dollars worth of an injectable blood-clotting medicine -- Factor VIII concentrate, intended for hemophiliacs -- to Asian, Latin American, and some European countries in the mid-1980s, although they knew that it was tainted with AIDS. The company stopped selling the drug in the United States in 1984, but continued to sell it overseas for an additional year." Reducing government regulation of drug companies increases the chances of similar underhand practices, as companies can claim they were following the laws they were intended to comply with. > "At the very least we should be allowing drugs to be sold that have been trialed and approved in other first world markets." That still limits the pool of companies that can afford it to a select few. It's very expensive to bring a new drug to market, even if you limit the trials to a single market. To give an idea of how much these clinical trials cost... http://journals.sagepub.com/doi/abs/10.1177/1740774515625964?journalCode=ctja http://journals.sagepub.com/doi/abs/10.1177/1740774515625964... "Therapeutic area was an important determinant of clinical trial costs by phase. The average cost of a Phase 1 study conducted at a US site ranged from US$1.4 million (pain and anesthesia) to US$6.6 million (immunomodulation), including estimated site overhead and monitoring costs of the sponsoring organization. A Phase 2 study cost from US$7.0 million (cardiovascular) to US$19.6 million (hematology), whereas a Phase 3 study cost ranged from US$11.5 million (dermatology) to US$52.9 (pain and anesthesia) on average. Across all study phases and excluding estimated site overhead costs and costs for sponsors to monitor the study, the top three cost drivers of clinical trial expenditures were clinical procedure costs (15%–22% of total), administrative staff costs (11%–29% of total), and site monitoring costs (9%–14% of total)."
Turing_Machine 9y ago
Many have argued that the regulatory incentives are skewed with respect to pharmaceuticals. 1) Company A's drug is approved, but causes 10,000 people per year to suffer sudden death. 2) Company B's drug is not approved, even though it would have saved 10,000 lives per year. The problem here is that scenario #1 makes the regulatory agency look bad, while #2 generally does not. Those patients (and even their doctors) usually won't know that there was a treatment available. This creates an incentive for non-approval.

ZenoArrow 9y ago

> " the regulations should be subject to a cost-benefit analysis" Not everything related to pharmaceuticals boils down to a cost-benefit analysis. If companies sell a drug with known side effects, but cover it up to make a profit, that might make business sense to its shareholders, but it's not something that benefits society at large. To give an example, Bayer knowingly sold products that were known to give people hepatitis C and HIV. https://en.wikipedia.org/wiki/Contaminated_haemophilia_blood_products https://en.wikipedia.org/wiki/Contaminated_haemophilia_blood... "Contaminated haemophilia blood products were a serious public health problem in the late 1970s up to 1985. These products caused large numbers of haemophiliacs to become infected with HIV and hepatitis C. The companies involved included Alpha Therapeutic Corporation, Institut Mérieux (which then became Rhone-Poulenc Rorer Inc., and is now part of Sanofi), Bayer Corporation and its Cutter Biological division, Baxter International and its Hyland Pharmaceutical division. Estimates range from 6,000 to 10,000 haemophiliacs in the United States becoming infected with HIV." https://articles.mercola.com/sites/articles/archive/2006/08/05/bayer-sells-aids-infected-drug-banned-in-us-in-europe-asia.aspx https://articles.mercola.com/sites/articles/archive/2006/08/... "Recently unearthed documents show that the drug company Bayer sold millions of dollars worth of an injectable blood-clotting medicine -- Factor VIII concentrate, intended for hemophiliacs -- to Asian, Latin American, and some European countries in the mid-1980s, although they knew that it was tainted with AIDS. The company stopped selling the drug in the United States in 1984, but continued to sell it overseas for an additional year." Reducing government regulation of drug companies increases the chances of similar underhand practices, as companies can claim they were following the laws they were intended to comply with. > "At the very least we should be allowing drugs to be sold that have been trialed and approved in other first world markets." That still limits the pool of companies that can afford it to a select few. It's very expensive to bring a new drug to market, even if you limit the trials to a single market. To give an idea of how much these clinical trials cost... http://journals.sagepub.com/doi/abs/10.1177/1740774515625964?journalCode=ctja http://journals.sagepub.com/doi/abs/10.1177/1740774515625964... "Therapeutic area was an important determinant of clinical trial costs by phase. The average cost of a Phase 1 study conducted at a US site ranged from US$1.4 million (pain and anesthesia) to US$6.6 million (immunomodulation), including estimated site overhead and monitoring costs of the sponsoring organization. A Phase 2 study cost from US$7.0 million (cardiovascular) to US$19.6 million (hematology), whereas a Phase 3 study cost ranged from US$11.5 million (dermatology) to US$52.9 (pain and anesthesia) on average. Across all study phases and excluding estimated site overhead costs and costs for sponsors to monitor the study, the top three cost drivers of clinical trial expenditures were clinical procedure costs (15%–22% of total), administrative staff costs (11%–29% of total), and site monitoring costs (9%–14% of total)."

Turing_Machine 9y ago

Many have argued that the regulatory incentives are skewed with respect to pharmaceuticals. 1) Company A's drug is approved, but causes 10,000 people per year to suffer sudden death. 2) Company B's drug is not approved, even though it would have saved 10,000 lives per year. The problem here is that scenario #1 makes the regulatory agency look bad, while #2 generally does not. Those patients (and even their doctors) usually won't know that there was a treatment available. This creates an incentive for non-approval.