The oped piece you cited does not support your assertion that the "FDA is incompetent and corrupt". They may be, but that is a pretty hefty accusation and requires more evidence.
Nor, honestly, does it support the "getting a drug approved is more dependent on how much money you want to spend than on whether it works" claim, or the "some drugs that may be effective are delayed for years and years".
Developing a drug is an incredibly complex operation. The FDA requires evidence that a drug will not kill people before it will approve it, which means that most drugs need to be tested in thousands of people. That requires outsourcing clinical trials to hospitals, which are then paid per patient to take on the extra work.
The original link cites corruption at the hospital level, which does seem like the weakest link in the system. The hospitals/doctors get paid based on getting patients through the trial protocol, or at least saying they did. Much of the cost born by pharmaceutical companies is actually auditing this process, to make sure it happens correctly.
Just yelling about the FDA will not change the corruption practices of a hospital in China.
> The original link cites corruption at the hospital level, which does seem like the weakest link in the system.
If corruption stopped at the hospital there, then this wouldn't happen at the FDA:
> As David Ross, the FDA official in charge of reviewing Ketek’s safety, put it, “In January 2003, over reviewers’ protests, FDA managers hid the evidence of fraud and misconduct from the advisory committee, which was fooled into voting for approval.”
Corruption goes beyond the hospital level and it extends into the FDA itself.
> As part of the new drug application process, or, more rarely, when the agency gets a tipoff of wrongdoing, the FDA sends a bunch of inspectors out to clinical sites to make sure that everything is done by the book. When there are problems, the FDA generates a lot of paperwork—what are called form 483s, Establishment Inspection Reports, and in the worst cases, what are known as Warning Letters. If you manage to get your hands on these documents, you’ll see that, most of the time, key portions are redacted: information that describes what drug the researcher was studying, the name of the study, and precisely how the misconduct affected the quality of the data are all blacked out. These redactions make it all but impossible to figure out which study is tainted.
"FDA managers hid the evidence of fraud and misconduct from the advisory committee, which was fooled into voting for approval"
-> Yes, that sounds super sketchy. The actual testimony doesn't, though it's one sided (below).
The redactions are not surprising to me. The FDA is a regulatory agency that deals with very sensitive and confidential information. They are not a criminal agency, and this isn't some district attorney asking for the information.
The testimony:
"""
After considering the fact that the investigation results
were preliminary and we had not received formal recommendations
about how to take the results into account in review of the
application, and the fact that only in very rare cases do
inspection results from individual sites lead to the exclusion
of an entire large clinical trial, FDA decided to hold the
Advisory Committee meeting as planned. The Agency made this
decision, knowing that any advice from the Committee would have
to be later taken into account in the context of additional
information about the integrity of data from Study 3014. It is
not unusual for more information to come to FDA for review
after an Advisory Committee meeting is held about an
application. The Advisory Committee voted that the safety and
efficacy of the requested indications had been demonstrated,
based on the information it was provided, including Study 3014,
and limited international post-marketing data provided at the
meeting.
Although the Advisory Committee recommended approval, on
January 23, 2003, (two weeks after the Advisory Committee
meeting) FDA issued another approvable letter to the sponsor
because of the remaining questions about the safety of Ketek.
The letter specifically noted the unresolved data integrity
issues associated with Study 3014 (issues confirmed in the
final clinical inspection summary of the Agency's audits of the
first three clinical trial sites) and the incomplete post-
marketing safety data from foreign countries. FDA noted that
the final decision regarding approval of each indication would
be made after a review of the information and analyses
requested in this letter.
On March 3, 2003, during a closed session of the Advisory
Committee convened to discuss other matters, FDA briefly
explained that an approvable letter was issued because the
Agency wanted to see more information about data from Europe
and Latin America. With regard to Study 3014, FDA explained
that there were unresolved inspectional issues.
Third Cycle. The sponsor submitted a complete response to
the approvable letter in October 2003. The October 2003
submission addressed issues of Study 3014 and included post-
marketing reports for spontaneous adverse events for
approximately four million prescriptions for patients in other
countries where Ketek had already been approved. Upon
completing the review of the sponsor's October submission,
including the findings from the additional audits of clinical
trial sites summarized in a March 2004 memorandum from the
Division of Scientific Investigations, the Agency decided that
it could not rely on Study 3014 to support approval of Ketek
because of the systemic failure of the sponsor's monitoring of
the clinical trial to detect clearly existing data integrity
problems. Accordingly, Study 3014 was dropped for consideration
in making the decision whether to approve Ketek. The Agency
considered data from other clinical trials and the
international post-marketing experience to conclude there was
adequate evidence of safety.
"""
> The redactions are not surprising to me. The FDA is a regulatory agency that deals with very sensitive and confidential information. They are not a criminal agency, and this isn't some district attorney asking for the information.
Yes the FDA is a regulatory agency. In my mind, it's similar to the IRS, SEC, or FBI. It ensures that specific people and organizations are complying with rules and regulations; in other words they enforce the law. Also I'm not sure how the agency has to hide whole bogus studies to protect confidential information. It's not like they can't redact sensitive portions (things like drug names and misconduct don't count) of it instead of just hiding the whole thing. Am I wrong?
Maybe... Technically it's not their study, it's the study of the company running the trial. That isn't public information.
Now, one could argue that all clinical and pre-clinical data used for the drug approval process should be public information. That is a very complicated argument (and I actually come down on the "public" side, but it would take a long time to explain).
Nor, honestly, does it support the "getting a drug approved is more dependent on how much money you want to spend than on whether it works" claim, or the "some drugs that may be effective are delayed for years and years".
Developing a drug is an incredibly complex operation. The FDA requires evidence that a drug will not kill people before it will approve it, which means that most drugs need to be tested in thousands of people. That requires outsourcing clinical trials to hospitals, which are then paid per patient to take on the extra work.
The original link cites corruption at the hospital level, which does seem like the weakest link in the system. The hospitals/doctors get paid based on getting patients through the trial protocol, or at least saying they did. Much of the cost born by pharmaceutical companies is actually auditing this process, to make sure it happens correctly.
Just yelling about the FDA will not change the corruption practices of a hospital in China.