President Trump, another "Vioxx" tragedy could very easily happen in America.

President Trump, another "Vioxx" tragedy could very easily happen in America.

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Melanie Burkhold started this petition to President Donald J. Trump and

FDA approved does NOT always mean safe or effective.

I am a Registered Nurse and Certified Clinical Research Coordinator in SC with many years of experience in conducting clinical drug trials in dozens of indications. I am addressing in this petition changes that are needed to protect human research participants, research whistleblowers, and the public. 

The Food and Drug Administration (FDA) is NOT protecting human research participants or public health. Drugs are being FDA approved when clinical drug trials failed to protect human research participants and/or with very bad research data and when significant conflicts of interest are not being addressed. 

Dr. David Graham, Associate Director of Science and Medicine at the FDA, bravely came forward in 2004 and blew the whistle that fundamental problems at the FDA and Vioxx were responsible for the deaths of thousands of people. Dr. Graham experienced severe retaliation in his professional and private life. The Government Accountability Project (GAP) was able to save his career and reputation due to legal protection for Government Whistleblowers. 

What about the researcher in the private sector who knows of another "Vioxx" about to be FDA approved or is FDA approved, research participants not being fully informed or protected, significant conflicts of interest but will not come forward due to no legal protections. The majority of clinical drug trials are being conducted in the private sector. 

We need legislation that will do the following: make informed consents used in clinical drug trials more transparent, increase clinical drug trial record retention, stall the revolving door between the FDA and Pharma, and protect research whistleblowers in the private sector. These measures will not only protect people but will also have significant economic advantages. In addition, the FDA needs to make some changes which do not require any legislative involvement to better protect human research participants and the public.

Protecting people who participate in a clinical drug trial starts with properly informing them of the risks involved. The FDA outlines in its Code of Federal Regulations (21 CFR 50.25) that human research participants are to be informed on the written informed consent of any reasonably foreseeable risks. The FDA has punted the approval of the language used within informed consents to Independent Review Boards (IRBs), but the IRBs are to follow federal regulations concerning research consents. The FDA may require that a Pharmaceutical Company submit the informed consent to the FDA at the commencement of the clinical drug trial if there is a concern about the risks, but this is not required. The FDA typically does not see the informed consent until the New Drug Application (NDA) and the Pharma payment are submitted asking for FDA drug approval. 

Problem: The FDA Code of Federal Regulations (CFR) needs to add language as to more fully inform research participants. Read the cases below and decide if you think these research participants were fully informed. A very simple solution follows each case, and the FDA should take prompt actions as to implement these protections.

Phase I clinical drug trials are basically when you take the drug from one mammal (i.e., rat, guinea pig, dog, rabbit, etc.) to another (humans). We want to determine if it is safe for a human to take the drug and at what dose is safe. Just because a drug appeared safe in one mammal does not mean it is safe for another. 

What do you think of a Phase I consent that contained the word TREATMENT in the title of the research and TREATMENT and THERAPY throughout the consent. The participants had terminal cancer and were not fully informed that this was a SAFETY trial. Imagine if that were you or a loved one seeing over and over again TREATMENT. This was a vulnerable population due to the terminal diagnosis, and the participants and family should have been properly informed on the informed consent that this was a SAFETY trial. Some may ask what did they have to loose given the circumstances, and the response is their fundamental rights. Keep in mind that many Phase I trials are being conducted at very prestigious American university/hospital settings where a potential research participant, especially a vulnerable one, could be easily influenced to participate due to the setting and wording of a consent.

Solution: FDA, please change FDA CFR Elements of Informed Consent (21 CFR 50.25) to include that Phase I informed consents CAN NOT contain the word treatment or any language that conveys efficacy for the participants. Existing Phase I informed consents with such language should be required to make immediate changes to the consent and send the amended consent for an expedited IRB approval. This does not require legislative changes.
 

Most have heard about the novel oral anticoagulants (NOAC), blood thinners, lawsuits concerning patients being unaware that there was NO antidote (reversal). What do you think if some in this class made it to market based on clinical drug trials where the informed consent did not inform research participants that the investigational NOAC had NO antidote and also did not inform participants that the comparator (Coumadin) did have an antidote (Vitamin K). In my opinion, if the informed consent had included that Coumadin had an antidote it would have brought attention to the fact that the investigational drug did not have an antidote.

Do you think some participants may have decided against participating in a clinical drug trial if they had been fully informed that one drug did NOT have an antidote but the other did, and that both the researcher and participant would be “blinded” as to which drug was assigned. Was simply putting on the informed consent rare chance of serious bleeding which may be fatal with either drug enough to meet the criteria of fully informed.  A foreseeable risk was known which was that there would be NO antidote in the event of serious bleeding if placed on the investigational drug NOAC. Some may argue that the person obtaining the consent should have informed them of no antidote, but research must follow federal regulations which state that foreseeable risks are to be written on the informed consent and a copy given to the participant. If Pharma and the IRB approved the consent with that omission, then clinical sites may have been influenced into thinking that the inclusion of rare chance of serious bleeding which may be fatal with either drug was sufficient. Thousands of participants were needed for drug approval. If the informed consent had followed the FDA CFR concerning foreseeable risks, it is questionable if the numbers would have been there for drug approval.

Solution: FDA, please change FDA CFR Elements of Informed Consent (21 CFR 50.25) to include that whenever an investigational drug without an antidote is being compared to a drug with an antidote that the informed consent must state this information as to fully inform the research participants. Any existing informed consents lacking this information should be required to make immediate changes to the consent and send the amended consent for an expedited IRB approval. This does not require legislative changes. 

The FDA should not grant drug approval with the current submission in cases where the informed consent is grossly misleading with omissions and/or admissions. 

Problem: The informed consents being used in all clinical drug trials need to be declassified and not treated as Trade Secrets.

The FDA CFR (45 CFR 46.116(h)) now requires that clinical drug trials funded or supported by the government post the consent on a federal website stating the need for transparency and better consents. This posting is to occur at the close of clinical drug trial enrollment or no later than 60 days after last drug trial visit. What about all of the clinical drug trials that are not federally funded but Pharma/Academia supported and federally regulated?

  • Solution: Pharma/Academia should be required to post their consents utilizing the same guidelines as required with federally funded research. Since the protection of human research participants begins with a proper consent, then it should be considered reasonable to ask for such transparency for the medical prescribers, patients, and shareholders.

Pharma will argue that this is proprietary information. First of all, the FDA (42 CFR Part 11) requires that any research with an Investigational New Drug application (IND) and other applicable drug trials must post a summary of the drug trial on ClinicalTrials.gov or other federal public website. Secondly, not only can one find out information on a drug trial from ClinicalTrials.gov, they can also make some calls based on very public advertising campaigns for drug trials and inquire about the research.

The other argument may be that anyone can get a copy of an unsigned informed consent from the FDA through the Freedom of Information Act (FOIA). This will take at least a year and will be so heavily redacted that it looks like black construction paper. The FDA claims that the redactions are due to Trade Secrets. 

  • Solution: I would like for redactions to be lifted with the exception of personal identifiers on all research consents at the close of clinical drug trial enrollment or no later than 60 days after last drug trial visit. Nothing should be more transparent than the way we consent human research participants.

Problem: FDA (21 CFR 312.62(c)) (21 CFR 56.115) allows for the destruction of clinical drug trial records 2 and 3 years, respectively post marketed drug approval or research termination. If the trial is international, then record retention is regulated by the country of origin. The European Union (EU) regulation on clinical drug trial record retention is 25 years. 

  • Solution: We need legislative changes to increase clinical drug trial record retention to 12 years post marketed drug approval or research termination in the event the data needs to be reviewed for safety, data integrity, or litigation issues.

Problem: FDA Mission: The FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of drugs. The conflicts of interest and the structure of the FDA make it most difficult to follow its own mission. 

It is very well known that significant conflicts of interest are not being adequately addressed at the FDA. Sen. Grassley has often described the relation between the FDA and Pharma as "too cozy."

People who are serving on the FDA Advisory Committees concerning drug reviews are required to sign financial disclosure forms prior to or at the time of their involvement in the drug review process, but the real conflict occurs after the drug approval when these same people go work as an employee, consultant, or contractor for Pharma or one of the entities involved in the research. Nothing addresses this conflict of interest. 

FDA staff who conduct clinical drug trial audits such as for cause audits (i.e., specific complaints to the FDA, multiple protocol violations, high number of serious adverse events) and random audits are able to go work in some capacity (i.e, employee, consultant, contractor) for Pharma or one of the entities involved in the research that is part of the audit. This conflict of interest is not adequately addressed at the FDA.

  • Solution: Financial Disclosure forms need to be revised to include if there has been any communication in any forms whatsoever (i.e.,expressed, written, tacit) with the Pharma or other entity involved in the research concerning any benefits whatsoever in any forms (i.e., financial or indirect) past, currently or post drug approval (i.e., in the future). The form is to include the following statement: a willfully false statement is a criminal offense (U.S.C Title 18 Sec 1001). If such a conflict exists, this person may need to be recused from this particular drug review or audit and have no involvement whatsoever regarding the clinical drug trial. FDA should form an independent committee to evaluate conflicts of interest and make determinations concerning recusals. These solutions should not require legislative changes, and the FDA should take these necessary steps as to ensure that the FDA is following its own mission statement of protecting the public.
  • Solution: Any individual working in any capacity at the FDA involving clinical drug trials should be required to sign a contract stating that they agree not to work in any capacity (i.e., employee, consultant, contractor) for Pharma or any of the other entities involved in any of the research which they have been directly involved for a period of 3 years. They should also be recused from working on specific drug trials where they have had a relationship with Pharma or any of the other entities involved in the research 3 years prior. The European Medicines Agency (EMA) forbids or places restrictions on members who have had a relationship with Pharma at least 3 years prior from participating in advisory meetings.

Problem: People who are serving in the important role as FDA Commissioner are able to go work for Pharma is further evidence of the "revolving door" in Washington between federal regulators and the businesses (Pharma) they are supposed to oversee. The majority of FDA Commissioners have gone to work for Pharma after leaving the FDA. 

  • Solution: The appointed FDA Commissioner should be required to sign a legally binding agreement to not work for Pharma (directly or indirectly) as a consultant, employee, contractor, Board Member, or in any capacity for a period of 5 years after serving as FDA Commissioner.

Problem: We need to expand whistleblower protection at the federal level to include protection of researchers and "employees" in the private sector who have information concerning the safety/efficacy of the drug and/or the conduct of the research. As previously stated, the majority of clinical drug trials are being conducted in the private sector.

Human Research Protection comes from National (Belmont Report) and International (Nuremberg Code), International Conference for Harmonisation (ICH) Guidelines regardless if the trial is federally supported or not. If all researchers are to abide by these guidelines, then it is reasonable to argue that to "turn a blind eye" to wrongdoing and/or safety issues is in breech of the very guidelines that researchers are to follow.

If a whistleblower in the private sector is retaliated against such as a demotion or termination, then that researcher may be able to file a claim under Sarbanes-Oxley (SOX). Whistleblower protections expanded in 2014 under SOX to include an expanded definition of "employee" and inclusion of both privately-held and public companies. SOX has a very limited statute of limitations in that the whistleblower who experiences unlawful retaliation must file a report with Occupational Safety and Health Administration (OSHA) within 180 days which was already increased from 90 days. SOX also contains very limited definitions of retaliation/harassment. 

Most states have a Nurses Practice Act (NPA), and many states include language that states that a Registered Nurse must report safety concerns in order to protect patients. Nurses can also be held legally accountable for not reporting. This may protect some research nurses but will NOT protect all nurses or other researchers.

Solution: Pharma started largely funding the FDA drug review process and not taxpayers since the Prescription Drug User Fee Act (PDUFA) was passed in 1992. The FDA is beholden to Pharma and will not implement very much needed changes without legislative involvement. This is a Bipartisan issue. Sens. Grassley, Graham, Cruz, Warren, and Reps. Cunningham, Norman, Ocasio-Cortez, we need legislation that will declassify all clinical drug trial consents, increase clinical drug trial record retention, and require a waiting period between FDA/Pharma. Sen. Cruz and Rep. Ocasio-Cortez, please team up to help with the revolving door of FDA/Pharma like you are doing with members of Congress from becoming lobbyists. Sen. Warren, thank you for sending a letter to Dr. Scott Gottlieb asking him to resign from the Board of Pfizer due to conflicts of interest. I 100% agree with you concerning the need for Dr. Gottlieb to resign but do not agree with the negative tone towards the Trump Administration concerning the revolving door of government officials and corporations. I respectfully would like to add that Obama-Clinton appointed FDA Commissioner, Dr. Margaret Hamburg and her hedge fund husband, Peter Brown, had significant conflicts of interest. The point I would like to make is that FDA/Pharma conflicts of interest date back prior to the Trump Administration, prior to the Obama Administration, dates back many, many years. Sadly, so many people have been harmed and are continuing to get harmed by a federal agency due to nothing getting done to change this ongoing problem. 

In addition, we need legislation that will protect research whistleblowers in the private sector. Sen. Grassley has extensive knowledge concerning clinical drug trials, has been outspoken concerning FDA/Pharma conflicts of interest and is a huge advocate for whistleblowers' rights and protections. Researchers should not have to turn a blind eye or be retaliated against with no protections because of weaknesses and complexities in our legal system. 

European Union (EU) just passed landmark legislation (591 to 29) that gives Whistleblowers EU-wide high level of protection recognizing that they play a key role in many areas of society, including public heath. This important legislation was also passed due to previous fragmentation of protection between the states, and the EU loosing billions of euros each year due to corruption. 

President Trump and Dr. Sharpless, Acting FDA Commissioner, I am respectfully asking to meet with you. The Vietnam Veterans Memorial Wall has 60,000 names of our brave Americans engraved in it. It is believed that this is the same number (possibly much higher) of Americans who lost their lives due to the fundamental problems within the FDA and Vioxx. The American Opioid Epidemic is another tragedy where significant conflicts of interest played a key role. President Trump, please be the administration that says the FDA is going to get back to protecting the American people and not special interests. How many preventable tragedies have to keep unfolding with absolute NO changes at the FDA. I respect your decision to re-authorize PDUFA, but please consider the suggested changes within this petition which will better protect human research participants, research whistleblowers, and the public. Change.org recommends not starting at the top, I respectfully disagree.  

I have had the honor of working with some of the best Pharmaceutical companies in the world who value and respect human life by ensuring people who participate in their trials are protected and that the integrity of the research is intact. I greatly appreciate their wonderful contributions which have positively transformed lives. 

Such companies have allowed me not only to appreciate really excellent research, but to question when research falls dangerously short and more importantly to challenge a federal agency that is not only OK with this but rewards such research with the FDA stamp of approval.

Please sign this petition respectfully asking President Trump and the others to meet with me so that I can make an argument for these needed changes which will have huge safety and economic benefits. Thank you to President Trump and everyone else with whom I have requested a meeting for your service to our beautiful country. I am grateful. Thank you to those who are signing this petition asking for these changes. Gratefully, Melanie

 

 

 

 

 

 

 

 

 

 

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