Thuốc Vioxx của hãng dược Merck trong vòng 05 năm đã giết chết khoảng 60 ngàn người. (Tiến sĩ David J. Graham, FDA Hoa Kỳ.)
Chỉ tính mỗi mình vụ scandal thuốc tây Vioxx được coi là thảm họa thuộc loại bê bối nhất lịch sử tây y, tiến sĩ David J. Graham chuyên gia tại FDA ước tính chỉ trong vòng có 05 năm từ 1999 tới 2004, đã có ít nhất 28,000, đúng, ít nhất hai mươi tám ngàn người phải bỏ mạng do thuốc tây Vioxx gây ra. Ông David Graham là nhà dịch tễ học (epidemiologist) Giám Đốc về Khoa Học và Y Học tại Ban An Toàn Thuốc Tây của FDA (Associate Director for Science and Medicine in FDA’s Office of Drug Safety.) Ông nói như sau trong một phiên điều trần trước chính phủ Hoa Kỳ:
“Thuốc tây Vioxx là một thảm họa khủng khiếp, đồng thời là một sai phạm về mặt luật pháp rất tinh vi. Tôi cho rằng FDA với thiết chế hiện thời không có khả năng bảo vệ nước Mỹ khỏi một thảm họa khác tương tự vụ thuốc tây Vioxx. Chúng ta hầu như không có khả năng tự vệ.” 
Tiến sĩ David J. Graham là người giữ vai trò chính trong việc đưa ra ánh sáng thảm họa thuốc tây Vioxx chết người bậc nhất lịch sử này. Ngoài ra, ông cũng là nhân tố chính trong một số vụ phanh phui thuốc tây gây chết người khác.
Bài phỏng vấn tiến sĩ David J. Graham dưới đây tôi bắt tay dịch hồi năm ngoái 2017, nhưng vì không có thời gian hoàn thành nó, nên tôi sẽ đưa lên đây phần nhỏ tôi đã chuyển ngữ sang Tiếng Việt. Phần còn lại tôi để bản gốc bằng Tiếng Anh để quý anh chị tham khảo.
Spoiler: thuốc viêm khớp Vioxx do hãng dược Merck đẻ ra, được FDA Hoa Kỳ cấp phép, là nguyên nhân gây ra cái chết cho khoảng 60 ngàn người Mỹ chết, trong vòng 05 năm từ 1999 đến 2004. Tới năm 2004 hãng dược Merck phải rút bỏ cái thứ thuốc chuyên giết người này, và bồi thường tổng cộng chừng ba bốn tỷ đô la Mỹ.
Dù thảm họa thuốc tây Vioxx này không liên quan trực tiếp tới vaccine, nhưng qua bài báo này, tiến sĩ David Graham sẽ cung cấp cho chúng ta một cái nhìn của một “insider”, một người trong cuộc, để chúng ta hiểu rõ hơn sự đi đêm giữa các hãng dược big pharma với cơ quan quản lý y tế nói chung hay thuốc tây nói riêng tại Mỹ sẽ mang lại hậu quả tới cỡ nào cho sức khỏe và tính mạng của chúng ta và con cái chúng ta.
BẢN DỊCH VÀ BẢN GỐC CUỘC PHỎNG VẤN
FDA Incapable of Protecting U.S., Scientist Alleges 
FDA KHÔNG ĐỦ NĂNG LỰC BẢO VỆ NƯỚC MỸ
An interview with Dr. David J. Graham, associate director of the FDA’s Office of Drug Safety
By Dick Carozza
Tiến sĩ David J. Graham, một khoa học gia hơn 20 năm làm tại FDA Hoa Kỳ, nói rằng FDA lẽ ra đã phải ngăn chặn 60 ngàn cái chết do thuốc viêm khớp Vioxx gây ra. Nhưng ông cũng nói thêm là vấn nạn của FDA đã vượt xa khỏi một loại thuốc.
Bức tường dài và cong có tên Đài Tưởng Niệm Cựu Binh Chiến Tranh Việt Nam ở Washington DC Hoa Kỳ ghi danh 58 ngàn nam và nữ giới người Mỹ đã chết trong chiến tranh Việt Nam.
Vậy mà tiến sĩ David J. Graham nói rằng con số 58 ngàn đó vẫn ít hơn 2000 so với số người Mỹ chết do thuốc viêm khớp Vioxx gây ra.
“Từ năm 1999 tới 2004, ước tính có 20 triệu người Mỹ và 80 triệu người trên toàn thế giới đã dùng thuốc Vioxx,” Graham nói khi nhận giải thưởng 2005 Cliff Robertson Sentinel Award tại Hội Nghị Thường Niên Về Gian Lận 16th Annual ACFE Fraud Conference & Exhibition. “Chúng tôi ước tính có khoảng 140 ngàn người Mỹ đã bị bệnh đau tim do dùng Vioxx…và trong số đó, 60 ngàn người đã chết.” Ông Graham, phó giám đốc Văn Phòng An Toàn Thuốc (Office of Drug Safety) của FDA và là nhân viên FDA hơn hai mươi năm, nói thêm. “Vioxx là một ví dụ tiêu biểu cho thấy FDA đã sai phạm như thế nào, và là lý do tại sao tôi tin rằng việc cải tổ FDA là cực kỳ khẩn cấp.”
In November of last year, Graham testified before the Senate Finance Committee that the FDA had silenced him and his colleagues from reporting on the risks of Vioxx and other drugs. “The FDA has let the American people down and sadly betrayed a public trust,” Graham said during his testimony. He alleged that because the FDA is unduly influenced by the pharmacy industry it is “incapable of protecting America against another Vioxx. We are virtually defenseless.” Merck & Co Inc., the maker of Vioxx, has pulled the drug from the marketplace. Meanwhile, Vioxx civil trials continue.
Graham remains at the FDA but says he has been “marginalized by FDA management and not asked to participate in the evaluation of any new drug safety issues. It’s a type of ostracism.”
In the following interview with Fraud Magazine, Graham says that “if I failed to speak the truth, I would become part of the problem, and all these deaths would in part, be my responsibility, in the same way that FDA was and is, responsible for these deaths. The decision to speak the truth wasn’t difficult. My conscience guided me in the way I should go.”
What does it mean for you to be awarded the Cliff Robertson ACFE Sentinel Award?
I was taken by surprise when Toby Bishop telephoned to tell me I’d been selected to receive the Cliff Robertson Sentinel Award, and I was humbled by the realization that my efforts were appreciated by an organization dedicated to the pursuit of truth. I found it ironic that while FDA condemned me for speaking truthfully before the Senate Finance Committee, that there were others outside of government who valued and respected what I had done.
In a nutshell, what has occurred in your professional and personal life since you testified before the U.S. Senate Nov. 18, 2004 about the dangers of Vioxx and the inadequacies of the Food and Drug Administration?
Professionally, I’ve been marginalized by FDA management and not asked to participate in the evaluation of any new drug safety issues. It’s a type of ostracism. At the same time, however, I’ve been able to pursue some research interests of mine. Personally, family life has been extremely stressful since my testimony with isolation and hostility at work and constant apprehension about possible retaliation by FDA management.
Your lawyer has described your position as “filling space under the scrutinizing watch of a babysitter.” What are your FDA duties now?
Officially, my duties have not changed, but in reality, I’ve been isolated. … I analogize it to Solzhenitsyn’s gulag, or to the Soviet Union’s internal exile in the city of Gorky.
In your message at the 16th Annual ACFE Fraud Conference & Exhibition you said that between 1999 and 2004 an estimated 20 million Americans took Vioxx. You’ve estimated that 140,000 of those Americans suffered heart attacks and of that number up to 60,000 died of those heart attacks. How did you calculate those last two figures? Can you talk more about the Vioxx problem?
The estimated number of fatal and non-fatal heart attacks was obtained by taking the results from two large clinical trials conducted by the company, that showed that high-dose Vioxx increased heart attack risk five-fold and lower dose, by two-fold. These risks were applied to the total number of people in the U.S. who took Vioxx, and the resulting numbers were what you mentioned in your question. I think it’s important to recognize that the number of Americans who died from Vioxx-related heart attacks could be very similar to the number of American soldiers killed during the Vietnam War. This was an enormous public health disaster which FDA did nothing to prevent. In fact, it is because of FDA’s disregard for safety and bias in favor of industry, that the number who died from the drug became so large.
You’ve worked for the FDA for more than 20 years. Had you come to loggerheads with them in the past? Is this first time that you’ve protested against its actions in such a public fashion?
Over the course of my career, I have found myself in the minority on many drug safety issues. For most of these, history ultimately showed that I was correct, but because of FDA’s reactive denial and delay, many thousands were needlessly injured or killed by the agency’s inaction. FDA consistently overrated the benefits of the drugs it approved and rejected, downplayed, or ignored the safety problems that ultimately led to their withdrawal.
Internally, I wrote many reports and gave many presentations where I recommended that serious regulatory action was needed, but this was typically ignored. It was only with Vioxx and the Senate Finance Committee hearing, that I was put in a position where I either spoke truthfully about a system run amok, or betray that truth and join with FDA in covering up the problem. If I failed to speak the truth, I would become part of the problem, and all these deaths would, in part, be my responsibility, in the same way that FDA was and is, responsible for these deaths. The decision to speak the truth wasn’t difficult. My conscience guided me in the way I should go.
What specifically do you believe is broken in the FDA and what needs to be done to fix it? What must be done to improve the drug vetting system?
FDA is inherently biased in favor of the pharmaceutical industry. It views industry as its client, whose interests it must represent and advance. It views its primary mission as approving as many drugs as it can, regardless of whether the drugs are safe or needed. Structurally, the large Office of New Drugs with FDA’s Center for Drug Evaluation, which is responsible for reviewing and approving drugs before they come to market, is the same office with the power and responsibility to regulate those drugs post-marketing when a safety issue emerges. This inherent conflict of interest results in unsafe drugs remaining on the market. The people who approved them are very reluctant to admit that a problem exists or that perhaps, a mistake was made by approving the drug in the first place. As a result, many thousands of Americans have died.
FDA’s culture is also at fault. The pro-industry bias leads to an environment where FDA tends to see things from industry’s perspective. Many are the advisory committee meetings where the drug company presentation and the FDA presentation are virtually super-imposable. It makes you wonder who wrote the presentations. Also, the emphasis at FDA is on approval, and the focus in on efficacy – that is, does the drug have an effect. Safety isn’t on the radar screen regardless of what FDA officialdom would have you believe. Scientifically, FDA uses statistics in a biased manner that favors industry at the expense of patient safety. You see, when FDA reviews a new drug, it assumes that the drug is safe, and it facetiously asks the company to prove that it’s not safe. Of course, there is no incentive for a company to prove that their drug is not safe because then FDA might not approve it. So, with a nod and a wink, drug companies jump through the very low hoops that FDA sets up for safety, and the public pays in two ways – with its money and its lives. Finally, FDA has a well-established history of suppressing its scientists, of pressuring them to change their recommendations and conclusions if they are unfavorable about a drug and retaliation against those scientists who don’t buckle under FDA pressure and threats. FDA calls itself the world’s leading consumer protection agency. If the public only knew the truth, they’d demand that Congress fix the problem. Of course, Congress has no intention of doing anything that would upset industry either. What has emerged is a lethal triangle involving FDA, the pharmaceutical industry and Congress. Pharmaceutical money funds FDA and exerts great influence with Congress. FDA allows deadly drugs onto the market and Congress pretends that nothing is the matter.
You’ve said that the FDA officials view the pharmaceutical industry as its clients and not the American people. Why is this and how did it come to be?
Beginning in 1992, with passage of the Prescription Drug User Fee Act (PDUFA), where drug companies began paying substantial amounts of money to FDA so that FDA could review and approve their drugs more quickly, there has been a steady shift in FDA’s cultural orientation. Currently, over 50 percent of the budget for FDA’s Center for Drug Evaluation comes from user-fees. If these dried up, it would be like a diver who has run out of air. You’ve heard the expression “he who eats the king’s corn marches to the king’s drummer,” and “he who pays the piper calls the tune.” Well, FDA is marching to the drum beat of industry as if its life depended on it.
This fatal development isn’t entirely FDA’s fault. When Congress passed this law, I suppose it’s possible that it didn’t realize that PDUFA would lead to FDA becoming a captive of the industry it’s supposed to regulate. However, that is what has happened, and to a disastrous end. With Vioxx alone, up to 60,000 Americans died, and for what? I’ll let your readers answer that question for themselves. Congress must admit that this unintended consequence is real, and do something about it. Unfortunately, Congress has for the most part, denied that any problem exists. So, FDA has blood on its hands, and with the next drug safety disaster, that blood will be on the hands of Congress as well. And then maybe as in Shakespeare’s MacBeth, we’ll hear Congress say “out out damned spot.”
In previous interviews, you’ve said that the FDA places almost complete attention, focus, and value on what it perceives to be the benefit of a product and almost completely discounts the risk side. How does this happen? Can you elaborate?
FDA is evaluated by the pharmaceutical industry and by higher levels of government by the metric of how many drugs does it approve and how quickly does it approve them. Nothing else matters. The “complaint” one sees most often in print, from pro-industry and right-leaning think tanks is that FDA isn’t approving drugs quickly enough and as a result, Americans are being denied “lifesaving” medicines. This is pure propaganda and deception. The truth is, most drugs submitted to FDA by the pharmaceutical industry are “me-too” drugs; that is, they’re very similar to other drugs already on the market that treat the same ailments. These “me-too”s do not represent a medical advance and do not offer meaningful advantages over existing, and frequently much cheaper, drugs. The reason for the deception and propaganda is money. Industry and its supporters want to make as much money as possible – money that comes out of the pockets of every American in one way or another.
Now, when reviewing a drug to decide if it should be marketed, the FDA focuses on efficacy; that is, does the drug have a biologic or pharmacologic effect. For example, does the drug lower blood sugar or blood pressure? Of critical importance, the efficacy of a drug usually has little or nothing to do with its benefit. In fact, for only a handful of drugs, do we have a quantitative measure of benefit. Health benefits might include things such as prolonging life or delaying the onset of blindness or kidney failure. But this is something FDA doesn’t measure and it’s really what physicians and patients are looking for when they prescribe or take medicines. So, when FDA approves a drug, it usually has no evidence that the drug will provide a meaningful benefit to patients. The fact that FDA has never performed a formal benefit analysis does not stop it from proclaiming to the world that for a particular drug with a well-defined and serious side effect, that the benefits exceed the risks. This too is propaganda and deception.
Two recent examples illustrate this dishonesty. With Vioxx, we had good clinical trials data as well as a large body of epidemiologic data showing that the drug substantially increased the risk of heart attack and sudden death. FDA never performed a formal evaluation of the actual benefit of Vioxx in the population. By its inaction, FDA implicitly said that the benefits of Vioxx continued to exceed its risks, and so it should remain on the market. When FDA did this, it was acting out of its bias in favor of drug companies. Many Americans died so that Vioxx could continue to be marketed. Interestingly, two published studies looking at benefit found that Celebrex was much better at preventing stomach bleeding than Vioxx.
The second example involves Serevent, a drug used to treat asthma. Before it was marketed in the U.S., FDA reviewed a clinical trial that suggested that Serevent might increase the risk of dying from asthma by three-fold. Because there was only 90 percent certainty that the risk was increased, and not 95 percent certainty, FDA approved the drug, presuming it was safe. If the weather forecaster said there is a 90 percent chance of rain tomorrow, would anyone doubt that it’s going to rain? Because of case reports of patient deaths on the drug, another clinical trial was performed. The results of this study were recently made public, showing that Serevent increased the risk of asthma death by four-fold. FDA held an advisory committee meeting where it failed to present data on the population impact of this four-fold increase in risk, and the committee voted unanimously that Serevent remain on the market. This level of risk translates to thousands of unnecessary excess deaths, and for what? FDA has never performed an analysis of benefit, to document the basis for its pronouncement that benefit exceeds risk. If a major point of asthma therapy is to prevent asthma death, what sense does it make to have an asthma drug on the market that has been shown to increase the risk of death from asthma 400 percent?
What’s the status of five drugs you mentioned in your Congressional testimony – Meridia, Crestor, Accutane, Serevent, and Bextra?
Ah, the “infamous five.” With Accutane, very little has changed and what FDA is planning to do is still far from adequate. Fifteen years ago, I proposed a means of reducing pregnancy exposure to this drug, but it was ignored. Curiously, after more than 45,000 pregnancy exposures to the drug, FDA is finally considering some of what I recommended, and even more curiously, this occurred after the patent on Accutane expired. Of note, the vast majority of these pregnancies were aborted. Sadly, I think the evidence supports the conclusion that FDA and the company used induced abortion as their risk management plan for Accutane, rather than adopt an effective program of pregnancy prevention. Such a program would have seriously cut into profits generated by the drug. So, under FDA’s watchful and approving eye, off-label use of Accutane increased nearly 300 percent, as did the number of exposed pregnancies. FDA is planning to announce a new program soon, but if past performance is any guide, this too will be woefully inadequate.
Bextra has been removed from the market. It’s interesting to note that the official reasons given by FDA for the withdrawal were all known and apparent either before approval or soon thereafter.
With Crestor, no additional regulatory action has been taken and the same holds for Meridia. As far as Serevent is concerned, FDA recently held an advisory meeting that concluded the drug should remain on the market. However, important safety information from two large clinical trials, both of which showed that Serevent substantially increases asthma deaths, was not presented or discussed. Over the past 11 years, Serevent has probably been a major cause of asthma death in the U.S. There are no benefits that I know of that outweigh the large number of deaths caused by this drug. Nonetheless, FDA orchestrated the advisory meeting to get the pat on the back it was looking for, and still, neither Congress nor the public have ever held FDA accountable for its fatal decisions.
Can you give some examples in which you believe the FDA has pressured you to supply a good review of a drug that didn’t deserve it?
With Arava, a drug for the treatment of rheumatoid arthritis, I did a study showing that Arava increased the risk of acute liver failure substantially without a correspondingly important benefit to offset this risk. I and a colleague recommended that Arava be withdrawn from the market. We were severely pressured to change our review, even to the point of being screamed at by a senior FDA manager while his supervisor and my supervisor looked on and did nothing to stop the abuse. Another favorite ploy is for a meeting to be held where multiple FDA managers from the Office of New Drugs criticize what you’ve done and ridicule you for having done it, with the intent that you’ll alter your report. This happened with Arava and with Vioxx.
Can you discuss what you believe to be the conflicts of interest on FDA advisory panels with specific examples?
FDA advisory panels are frequently heavily conflicted in several ways. First, the committee members are usually recruited by the FDA reviewing division directors, who are looking for people on the committee who see the world in a way similar to their own view. So, if you’re favorably predisposed to industry, you might look for committee members who are similarly inclined. Frequently, committee members are researchers at academic institutions who have performed studies for various drug companies in the past and may currently be conducting such research. This results in a situation where committee members may have a potential self-interest in adopting a pro-industry point of view. Most distressingly, however, advisory members frequently have active financial conflicts of interest that could influence decision making. This past February, FDA held an advisory meeting on the COX-2 pain relievers. The committee voted 17 to 15 in favor of bringing Vioxx back on the market and 17 to 13 in favor of keeping Bextra on the market. Of note, 10 panel members had financial relationships with drug companies that made COX-2 pain relievers. I did a statistical analysis of the voting and amazingly, if you had a financial conflict of interest, you were 16 times more likely to vote to keep Bextra on the market than if you had no such conflict, and for Vioxx, you were even more likely. The actual number couldn’t be calculated because everyone with a conflict voted to bring Vioxx back. Now, if you disqualified these panel members, Vioxx and Bextra were overwhelmingly rejected by the remaining committee members. But the real perpetrator here is FDA because FDA knew about these conflicts and “waived” them. The public needs to understand that FDA advisory meetings are carefully orchestrated, and the information that is presented is scripted and censored, so that a particular point of view is offered without serious challenge or examination. FDA uses its committees to provide it with the shield and support it needs to do what it wanted to do in the first place.
On Nov. 9, 2004, you spoke with then-acting FDA commissioner Lester Crawford. (Crawford is now the confirmed FDA commissioner.) What did you discuss and what was the outcome?
Dr. Crawford asked if I would come to the Commissioner’s Office to oversee the revamping of drug safety at FDA. I explained that I was a scientist, not a manager or a bureaucrat, and I could think of 10 or 12 people outside of FDA who would be perfect for this job, especially if at the end of it, this person was told they could be the director of a new Center for Product Safety.
You said that shortly before you appeared before the Senate to testify, senior FDA officials conspired in an organized, coordinated effort to intimidate you. How did you know that the effort was planned and what did they specifically do?
The effort to intimidate me prior to my Senate testimony was organized and premeditated, and though I’m not a lawyer, I would say it amounted to a conspiracy. Why do I say this? Well first, the day before the Senate announced there would be a hearing at which I would be testifying, I was invited to the FDA commissioner’s office where I was asked to consider leaving drug safety to move to the commissioner’s office. This is very strange because over the two previous months, I had been vilified by FDA management in the press and attacked and harassed by my own management in an attempt to get me to change my conclusions about Vioxx. Why would the commissioner want a vilified and hated “junk scientist” to move to his office to oversee the revamping of drug safety at FDA? It just didn’t make sense. And how did he know that I would be testifying? I imagine he was tipped off by senators friendly with industry.
After I turned down this offer, a series of “anonymous” phone calls were made by senior FDA managers to Senator Grassley’s office [Sen. Chuck Grassley (R-Iowa) is chair of the Senate Finance Committee. – ed.] and to Tom Devine, legal director of the Government Accountability Project (GAP), a non-profit organization that defends “whistleblowers.” These calls amounted to a smear campaign against me, maligning my character and integrity and accusing me of being a dishonest scientist and a liar. Some of these phone calls were made from government telephones (caller ID), which is a federal crime. Now the purpose of these calls was to discredit me as a witness and to possibly convince Senator Grassley that he should not have me testify, or if he did, then not to support or defend me afterwards. With GAP, the purpose was to convince Tom that his group should not represent me. If I lost the support of GAP, maybe I’d back away from testifying, and if I didn’t, well, I’d have no legal counsel or defense. But here’s the core evidence. There must be 10,000 lawyers in Washington, D.C. How on earth did these FDA managers know to call Tom Devine? The answer is simple. You see, in early 2004, FDA suppressed another FDA scientist who had concluded that SSRI antidepressants increased the risk of suicidality in children. FDA held an advisory committee meeting where it hid this information from the public and from its own advisory committee. This suppression of important safety information was leaked to the press by people within FDA and this embarrassed the agency. My supervisor ordered an internal criminal investigation to identify and imprison the perpetrators. Of course, no one from the Office of New Drugs was investigated. I contacted GAP and Tom Devine at this time because I didn’t want to have to hurt people I knew by testifying to these criminal investigators. Before they interviewed you, they made you sign a piece of paper saying that if you lied, and they found out about it, you could go to prison. Tom spoke with the investigators, and explained to them that their investigation was a crime because it violated three different federal laws and because it was simply a whistleblower witch hunt. Within days of this conversation, the investigation abruptly ended but not before the “official purpose” of the investigation was changed. No one knew that I had contacted Tom Devine except these criminal investigators, who put it in their report that was given to my supervisor. So, how did these other senior FDA managers know to call Tom Devine? I suppose it could be dumb luck, but I don’t think so.
Why hasn’t U.S. law enforcement listened to your complaints about the intimidation by senior FDA officials even though it’s a federal crime?
There is no law enforcement when it comes to the government investigating itself. In this regard, the government is above the law. And then there is the code of managerial and organizational loyalty. Basically, they can hang separately or together. By sticking together, FDA’s senior management create a barrier that’s difficult to penetrate. Finally, there is politics, and the investigations by the inspectors general are subject to the oversight and say-so of political appointees. This has been the case under administrations of both persuasions. So, despite federal laws being broken, none of the FDA managers responsible will ever answer for their offense. Indeed, they’ll probably be promoted. Isn’t that the American way?
In November of 2004, Sen. Grassley sent a letter to Daniel Levinson, acting inspector general of the Department of Health and Human Services, asking for an official investigation into whether the FDA has attempted to discredit you. What became of that investigation?
To my knowledge, the investigation by the IG has gone nowhere. I’ve heard rumors that it became biased and didn’t gather the appropriate evidence or interview key witnesses. But by now, we should all realize that the government does a really poor job of investigating itself. Talk about conflict of interest and bias.
Is the inspector general of the Department of Health and Human Services investigating any of your allegations? How about the General Accountability Office?
I’ve been told that the GAO investigation is proceeding and that a report may be available by September. Again, I’m skeptical that the report won’t get rewritten by higher-ups in government.
You’ve said that you have no viable legal rights under the Whistleblower Protection Act. Can you elaborate? Have you been placed under criminal investigation? Can you discuss current introduced legislation that might protect federal workers’ rights?
Currently, there is a federal Whistleblower Protection Act that was enacted into law a number of years ago, that was intended to give whistleblower protection to federal workers. Unfortunately, the First Amendment free-speech rights intended by that law have been interpreted away by the administrative courts, resulting in a situation where federal workers have absolutely no protection. In fact, the current WPA has become somewhat of a trap for government employees who see waste, fraud or public endangerment within government and try to bring it to public attention. In the private sector, Congress recently passed the Sarbanes-Oxley Act giving state-of-the-art free-speech rights to corporate truth-tellers (a.k.a. whistleblowers). In light of financial disasters such as Enron and WorldCom, Congress saw that such protection was needed if the country’s 401-K and pension plans were to be protected. We’re faced with a similar crisis within government, and sometimes, what we’re dealing with are the lives of thousands, if not tens of thousands of people like you or me or any of your readers. So, in reality, the public needs to know that if government scientists can’t protect themselves, how will they be able to protect them from unsafe drugs?
In both houses of Congress, there is currently a reinvigorated Whistleblower Protection Act that would provide government truth-tellers with the protections needed to ensure their First Amendment free-speech rights to bring into the sunshine waste, fraud, or public endangerment within the federal government. This bill would pass unanimously within both houses if it could come to a floor vote. However, I’ve been told that the political leadership in the House and the Senate will not allow the bill to come to a floor vote. Apparently, the Department of Justice is opposed to federal employees having the same free-speech rights as their counterparts in the private sector.
A 2002 Health and Human Services survey of almost 400 FDA scientists – almost 1/5 of the total number – found that a majority had significant doubts about the adequacy of federal programs to monitor prescription drugs once they’re on the market and that more than a third weren’t particularly confident of the agency’s ability to assess the safety of a drug. More than half of the respondents said they didn’t think there was sufficient time to conduct an in-depth, science-based review in the six months required for drugs given priority status. Do you feel the results of the survey (only fully released after your 2004 Congressional testimony) vindicate your concerns? I think the results of this survey, and several others that have been conducted (one by an outside FDA watch-dog group, Public Citizen, and another by FDA’s Center for Drug Evaluation) reveal that there is real substance behind the remarks I made during my Senate testimony. FDA professes to be a scientific and evidence-based organization that is not biased in favor of the industry that pays much of its operating budget. These surveys paint a very different picture. In a scientific organization, especially one dealing with patients’ health and lives, there should be no (zero) examples of suppression or intimidation of its scientists. Yet at FDA, this is normative, routine and commonplace. And then FDA goes to Congress and says no one is ever suppressed or pressured to change recommendations. Anyone looking at the objective evidence, and putting aside whether they’re a Democrat or Republican, conservative or liberal, would quickly see what the truth of the matter is. Regrettably, however, drug safety has become a political issue. Patient safety and public health should be bipartisan and above politics. But that is not what is happening because the pharmaceutical industry is extremely powerful and carries unimaginable influence within Congress and over the FDA
What are the personal costs from being a sentinel?
The personal costs have been high. From August of 2004, when I first came under fire by FDA management to change my conclusions and recommendations to a large study I had just completed, through this past February or March, life was hellish to say the least. Internal criticism, threats and ostracism, coupled with an orchestrated campaign of slander and innuendo, initiated and carried out by FDA managers, took a great toll on my family. Apparently, pharmaceutical representatives and lobbyists also participated in this smear campaign on Capitol Hill. Why? Because the last thing industry wants to see is an FDA where post-marketing drug safety actually has power and authority to protect the consumer. An investigation of this episode was requested by Senator Grassley, but as I mentioned before, it appears that the Inspector General investigation will cover-up and gloss over what occurred, only empowering FDA to do even worse things in the future.
What are your professional plans from here?
My passion is really with the field of drug safety, as a scientist and researcher, not as a manager or bureaucrat. And FDA is potentially the single best place to be to make a difference in the health and well-being of patients. So if I were able to, I’d like to continue my work at FDA. From time-to-time, I’ve looked at university jobs, but in this field, most drug safety research outside the government is funded by industry, which can be very constraining and, I believe, compromising. It’s well-established now that research funded by industry is four to five times more likely to reach a conclusion favorable to industry than if the research was funded by independent or neutral sources. The idea of working for industry also holds no appeal. Of course, I could always find plenty of work in the litigation field, but I’d much prefer to continue my work at FDA.
Have you received support (either private or public) from your colleagues and peers?
The support I have received from staff (but not management) within the Office of Drug Safety has been overwhelming and positive. It has also been out in the open. I have also received many phone calls or personal comments in the cafeteria or elevator from FDA staff working in other areas of the Center for Drugs. And then there are the hundreds of e-mails, letters, and phone calls I’ve received from the public, expressing their thanks and offering encouragement and prayers for me and my family.
After all that you’ve been through, would you do it again?
I have been asked this question several times and have thought about it at some length. I think the most honest answer I can give is that I wouldn’t want to have to go through such anxiety and stress again, but faced with the same circumstances, I would have no choice, really, because the pain of knowing that I had contributed to the deaths of patients by my silence would be too much to bear. It gets back to this matter of conscience, and acting in accordance with it, and then trusting in God’s providence. Human life is worth far more than a little difficulty at the office, and being able to look my children in the eye and for them to know that I have acted with integrity, is priceless. Plus, I’m able to sleep at night.
Dick Carozza is editor of Fraud Magazine.
Retrieved Sunday 22 April 2018.