Deleted Tweets From Scott Gottlieb, R-D.C.

NDMA has been found to increase the occurrence of cancer in animal studies. These animal studies were done using amounts of NDMA much higher than the impurity levels in recalled valsartan batches. Based on these animal studies, the EPA considers NDMA a probable human carcinogen.

RT @FDA_Drug_Info: New FDA update on valsartan recalls: Analysis of Impurity, N-nitrosodimethylamine (NDMA), Levels in Recalled Valsar… https://t.co/56MlWtVU24

RT @SeemaCMS: Great article by @kevinbtruong w/ @SFBusinessTimes on how @CMSGov is promoting consumerism in health care & giving… https://t.co/FP8PmMeTry

#FDA continues to update our list of valsartan-containing products affected by the recent recalls. We will continue to investigate and provide information when we can. See the latest update here: https://t.co/eS5dGp19eK

Based on records from the manufacturer of the recalled valsartan, some levels of the impurity may have been in the products for as long as four years. So #FDA's analysis assumed people were taking a version of the drug with the highest levels of impurity for four straight years

#FDA is working with Lipari Foods to recall certain Premo Brand and Fresh Grab turkey and Swiss submarine sandwiches due to potential Listeria contamination. No illnesses have been reported at this time: https://t.co/BCyBoeJHam

A good @nytimes article relating some important health information about choosing the right diet for your dog and some public health issues that the #FDA is actively evaluating: https://t.co/X9Dixu2NPA

For this weekend's #FDA #SUNDAYTWEETORIAL I’m going to talk about what FDA is doing to modernize clinical trials to reduce the cost of drug development, potentially lower drug costs and bring more safe, effective therapies to patients. https://t.co/YgtzUVLrmM

The traditional drug development paradigm calls for 3 clinical trial phases: A small phase 1 tests safety and dosing, phase 2 tests short-term side effects and effectiveness over a range of doses; and the large phase 3 assesses whether the product’s benefits outweigh its risks. https://t.co/Iijp7dN1fS

FDA’s mission is to both promote and protect public health. For medical products, this means ensuring that they are safe and effective for their intended use. Clinical trials are the primary vehicle for generating the evidence FDA needs to ensure that.

A soon to be published #FDA study found that nearly 5% of novel drugs approved from 1991-2000 had a competitor within 2 years. But it took 5 more years to achieve the same level of competition for drugs approved from 2001-2010. And less competition can mean higher prices.

The result: spiraling drug development costs. One estimate: Rising 145% to an inflation-adjusted $2.8 billion between 2003-2013, a pace that dwarfs other healthcare cost increases. Higher trial costs & complexity impacts market competition & drug pricing https://t.co/lK698L2Auj https://t.co/Avzg9ZmRtG

Adding to complexity is “endpoint creep”, with pharmaceutical companies spending $4-6 billion annually on non-core or exploratory endpoints that aren’t related to primary safety or efficacy endpoints. https://t.co/xbaFyxXxbC

Trials are becoming more costly & complex to administer. It can make drug development more risky, uncertain, time consuming. Overly complex trials can also deter enrollment & delay completion studies so long that findings aren’t relevant for patient care https://t.co/5XVPxWtwbg https://t.co/UW2c1BPMGr

We’ve been partnering with the nonprofit Clinical Trials Transformation Initiative on the design and conduct of clinical trials that can address these challenges while building on our gold standard. We will not compromise that gold standard one bit. https://t.co/Lt6ilRgCmm https://t.co/sa7ZVjJ3wN

One MAP, I-SPY 2, compares up to 12 experimental therapies in subgroups of patients with metastatic breast cancer with 10 distinct biomarker signatures. This hub and spoke design uses a common control, reducing the overall # of patients to be recruited and enrolled. https://t.co/flW5LAYbKa

One reason for the longer development period: It can be difficult to run clinical trials with a second to market drug once therapy is available to treat an unmet need or rare disease. It’s becoming harder and harder to be second.

And FDA has encouraged several pioneering advances in clinical trial design, including Master Clinical Trial Protocols (MAPs), first used in cancer and now used more widely across FDA, in other therapeutic areas. https://t.co/zKgR7GgM7Y.

Modern approaches to designing and conducting clinical trials can address some of these challenges. #FDA is working across our medical product centers to facilitate innovative trial designs and patient-centered endpoints that can make clinical trials more rigorous and efficient.

In cancer, innovative endpoints are facilitating the development of products for both accelerated and traditional approvals putting promising treatments into the hands of high-risk patient years before they would’ve been available using previous endpoints.

NDMA has been found to increase the occurrence of cancer in animal studies. These animal studies were done using amounts of NDMA much higher than the impurity levels in recalled valsartan batches. Based on these animal studies, the EPA considers NDMA a probable human carcinogen.

RT @FDA_Drug_Info: New FDA update on valsartan recalls: Analysis of Impurity, N-nitrosodimethylamine (NDMA), Levels in Recalled Valsar… https://t.co/56MlWtVU24

RT @SeemaCMS: Great article by @kevinbtruong w/ @SFBusinessTimes on how @CMSGov is promoting consumerism in health care & giving… https://t.co/FP8PmMeTry

#FDA continues to update our list of valsartan-containing products affected by the recent recalls. We will continue to investigate and provide information when we can. See the latest update here: https://t.co/eS5dGp19eK

Based on records from the manufacturer of the recalled valsartan, some levels of the impurity may have been in the products for as long as four years. So #FDA's analysis assumed people were taking a version of the drug with the highest levels of impurity for four straight years

#FDA is working with Lipari Foods to recall certain Premo Brand and Fresh Grab turkey and Swiss submarine sandwiches due to potential Listeria contamination. No illnesses have been reported at this time: https://t.co/BCyBoeJHam

A good @nytimes article relating some important health information about choosing the right diet for your dog and some public health issues that the #FDA is actively evaluating: https://t.co/X9Dixu2NPA

For this weekend's #FDA #SUNDAYTWEETORIAL I’m going to talk about what FDA is doing to modernize clinical trials to reduce the cost of drug development, potentially lower drug costs and bring more safe, effective therapies to patients. https://t.co/YgtzUVLrmM

The traditional drug development paradigm calls for 3 clinical trial phases: A small phase 1 tests safety and dosing, phase 2 tests short-term side effects and effectiveness over a range of doses; and the large phase 3 assesses whether the product’s benefits outweigh its risks. https://t.co/Iijp7dN1fS

FDA’s mission is to both promote and protect public health. For medical products, this means ensuring that they are safe and effective for their intended use. Clinical trials are the primary vehicle for generating the evidence FDA needs to ensure that.

A soon to be published #FDA study found that nearly 5% of novel drugs approved from 1991-2000 had a competitor within 2 years. But it took 5 more years to achieve the same level of competition for drugs approved from 2001-2010. And less competition can mean higher prices.

The result: spiraling drug development costs. One estimate: Rising 145% to an inflation-adjusted $2.8 billion between 2003-2013, a pace that dwarfs other healthcare cost increases. Higher trial costs & complexity impacts market competition & drug pricing https://t.co/lK698L2Auj https://t.co/Avzg9ZmRtG

Adding to complexity is “endpoint creep”, with pharmaceutical companies spending $4-6 billion annually on non-core or exploratory endpoints that aren’t related to primary safety or efficacy endpoints. https://t.co/xbaFyxXxbC

Trials are becoming more costly & complex to administer. It can make drug development more risky, uncertain, time consuming. Overly complex trials can also deter enrollment & delay completion studies so long that findings aren’t relevant for patient care https://t.co/5XVPxWtwbg https://t.co/UW2c1BPMGr

We’ve been partnering with the nonprofit Clinical Trials Transformation Initiative on the design and conduct of clinical trials that can address these challenges while building on our gold standard. We will not compromise that gold standard one bit. https://t.co/Lt6ilRgCmm https://t.co/sa7ZVjJ3wN

One MAP, I-SPY 2, compares up to 12 experimental therapies in subgroups of patients with metastatic breast cancer with 10 distinct biomarker signatures. This hub and spoke design uses a common control, reducing the overall # of patients to be recruited and enrolled. https://t.co/flW5LAYbKa

One reason for the longer development period: It can be difficult to run clinical trials with a second to market drug once therapy is available to treat an unmet need or rare disease. It’s becoming harder and harder to be second.

And FDA has encouraged several pioneering advances in clinical trial design, including Master Clinical Trial Protocols (MAPs), first used in cancer and now used more widely across FDA, in other therapeutic areas. https://t.co/zKgR7GgM7Y.

Modern approaches to designing and conducting clinical trials can address some of these challenges. #FDA is working across our medical product centers to facilitate innovative trial designs and patient-centered endpoints that can make clinical trials more rigorous and efficient.

In cancer, innovative endpoints are facilitating the development of products for both accelerated and traditional approvals putting promising treatments into the hands of high-risk patient years before they would’ve been available using previous endpoints.