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I’m looking forward to how Canada’s shift to more transparency will change the industry. It is frustrating that most of the publicly available data for FDA registered studies are typically summaries of the trial data rather than full clinical reports. More transparency would be better for public oversight and make it easier for other researchers to replicate studies.
Greater transparency in the new drug approval process would be a positive for consumers, prescribers, and public health policy makers. My background is in pharmacy with familiarity in using both International Council for Harmonisation (ICH) marketing authorization documents that include Clinical Study Reports (CSRs), and US Food and Drug Administration (FDA) drug approval packages in assessing new drug safety and efficacy. These comments relate the potential value of FDA drug approval packages to the public compared to CSRs.
Transparency advocates have underutilized FDA drug approval packages while promoting greater access to CSRs. Approval packages are not simple reviews, but rather extensive analyses of data submitted by manufacturers to support the approval of new drugs. In theory, FDA drug approval packages contain ICH formatted information. They may be hundreds of pages of analyses and are free to the public because of the Freedom of Information Act (FOIA) and are available on the FDA’s web site.
FDA drug approval packages may contain agency analyses that are not found in ICH based new drug submissions. Quick examples are the nonsteroidal anti-inflammatory drug (NSAID) Arcoxia (etoricoxib) that was refused approval in the US. Another NSAID Dynastat (paracoxib) likewise was not approved for US marketing. Another example is the antipsychotic drug Serdolect (sertindole) also denied marketing authorization in this country.
Additional observations on transparency advocates comments in your NPR posting:
1. Transparency advocates maintain that independent assessment of the safety and efficacy of a drug or device would be possible. There is no way to assure that any author or group of authors is truly independent.
2. Transparency advocates state that the FDA, on the other hand, continues to treat this information (new drug applications) as confidential to companies and rarely makes it public.
This is not entirely true. The FDA carefully analyzes manufacturers’ new drug applications, writes their own reports, and then makes them publically available on the Internet through FOIA. By writing and posting their own work the FDA avoids many of the legal restrictions on releasing manufacturers’ data.
3. Diclectin for Morning Sickness
The transparency advocates have called into question the efficacy of the morning sickness drug Diclectin (known as Diclegis in the US), a combination of a combination of vitamin B6 and a common antihistamine.
The efficacy of Diclectin is clearly small, not zero. Transparency advocates could have verified this by accessing the Diclegis approval package on the FDA web site.
4. If the FDA approves a drug first, which often it does, we won’t know anything until Health Canada or the EMA makes a decision was a statement made by transparency advocates.
The first market for a new drug is a manufacturer business decision. The US is often the first market because industry is allowed to set the price for a new drug. A rule used by many in new drug safety and efficacy review was to wait for US approval before recommending a new drug’s approval.
5. Journal articles emphasize benefits and underplay or, in some cases, even ignore harms that can be found in the clinical study report data according to transparency advocates.
This has been understood for years. Given the small number CSRs released to the public, accessing FDA approval packages is far more useful.
6. Tamiflu (oseltamivir) for influenza
Tamiflu was approved in the US in October 1999. When the Tamiflu approval package is accessed it is found that the drug reduces the duration of flu symptoms by about a day and evidence was not submitted by the drugs manufacturer to support a claim of reducing the bacterial complications of influenza.
7. One transparency advocate maintains that analyses by FDA reviewers are no substitute for the actual clinical study reports (CSRs). FDA approval packages contain information derived from ICH marketing authorization documents and focus on what are the most important clinical trials, those that are used as the bases for marketing approval.
CSRs released alone without FDA quality assessment in agency approval packages would create new perverse markets to compete in, for example, speed of review and data dredging to cast doubt on the safety and efficacy of competing drugs.
FDA regulations allow the public to petition the agency to require removal of drugs from the market or add safety warnings to the labeling for specific drugs. The agency must respond to these petitions. Have the transparency advocates proposed ways to address public criticism of their work?
Thank you for this opportunity to comment.
Larry D. Sasich, PharmD, MPH, FASHP
What is intriguing is how the market for new drugs will change as a result of this move by Canada. Will the same products be marketed in Canada and US? Also, I bet clinical data disclosure on opioids will cause a storm of law suits.
Canada has a pubic health interest in allowing the public and practitioners to view this information, while the US no longer has any functional regulatory systems. In the US patients are viewed as “consumers.” and corporate marketing has replaced fact based information. The FDA no longer answers to any public health concerns, unless they can be re-framed in a way to increased corporate profits. The pharmaceutical industry runs our regulatory agencies, like the FDA, while regulations put in place to protect patients and “consumers” are no longer enforced.
The industries have been gas lighting us all, holding back research with negative outcomes, funding only research that promotes their products and forcing Americans to turn to advertising, and corporate propaganda for information.
It should be really clear by now that with the only information available, coming from marketing materials, paid journalists/advertisers, and content marketing, that action will only be taken on dangerous drugs after years of lies and denial.
The industry along with their close friends in the regulatory agencies know that some of the research, could lead to questions or cut into profits, that is why this information is not readily available.
Researchers physicians and policy makers have all been silenced unsure of releasing proprietary information. They are reminded daily of incredible power of these corporations in silencing critics or fact based evaluation. This is the result of unregulated for profit medicine. Incentives like public health interest no longer apply, the only thing that does is profit or market share.
We have been hearing about initiatives like this for decades, remember when the Internet was supposed to “democratize” research and medicine. Instead we have had the throttling of all of it, as it is passed through corporate censorship. Divulging any negative mention of a pharmaceutical could lead the loss of credibility, career and even worse.
Thank you for alerting and summarizing the situation so clearly. More transparency is appropriate and necessary. In an inter-connected world it is best and increasingly useful to have as many knowledgeable eyes on the raw data as possible.
It is interesting that many researchers do not realize that clinical study reports are available. Hopefully, articles like this will increase awareness.