The system, of safeguards for those who disclose information in the public interest and Whistle blowing

Toshihiro Okuyama(A journalist, The Asahi Shinbun Company)

1. Intorduction

I began to work as a newspaper journalist in 1989. In the next year, the bubble-economy burst. Japan's economy began to go down and many cases of misconduct of banking institutions were discovered. I covered and reported the cases as a journalist.

In the coverage, I waited for the individual whom I wanted to interview in front of the house at midnight and early morning and gathered the data. I tried to interview individuals secretly. In some cases, people voluntary contacted me in order to give me insider information; that was a whistle-blowing.

It was the year 2002 when I began to cover the theme "protection of whistle-blowers" with a colleague. I began running a series on the theme in the Asahi Shimbun and wrote 30 articles in a period of approximately six months. Some of those are in a collection in a book introduced earlier, Naibukokuhatsu no Chikara (The Power of Whistleblowing).

Today I will have lectures on the protection of whistle-blower from the three view points; 1) Why did deceptions or false reports reach a point of accusation? - Request of disclosure and accountability 2) who should workers work for or who should workers comply with?-compliance and shareholders' right 3) the emergence of the concept of governance in Japan-risk management by mutual supervision.

2.Intensifying of Accusation to Deception or False Reports

Today, to cover up or to falsify misconduct began to be recognized as a more serious crime than the misconduct. I think the interest in whistle browning is increasing now in this atmosphere.

Formerly, to cover up or falsify reports such as those that misled investors was recognized as a misdemeanor. For example, the inaccurate information in official income/output reports, lies in company securities reports, and the Livedoor incident. However the trend changed in 1990's.

False reporting to the authorities and false information to the market are becoming recognized as more serious crime in the past 10 years.

10 years ago, the misconduct by Mr.Iguchi, the exective vise president of the NY branch office of Yamato Bank, was discovered. It is natural that Mr.Iguchi was accused; however Yamato bank was also charged even though it is a victim of the misconduct. What was Yamato bank charged with? Yamato bank did not report the misconduct soon to US authorities because the Ministry of Finance Japan told it to deal with the misconduct in secret. Then the American government accused it.

6 years ago, it was discovered that Mitsubishi Mobile Ltd. had covered up their defective autos for about 30 years. The accusation of a cover-up was bigger than the fact that they produced lemons. What is worse is that the company covered up and falsified the evidential documents when the Ministry of Transport investigated their lemons. The company did not get rid of the responsible officials. As a consequence, the CEO of the company in 2000 was arrested in 2004.

As shown above, falsification and cover-up is recognized as a more serious crime or sin today than in the past. Today most companies recognize that to ignore a whistle may bring more serious problems.

3. Who do company employees work for?

Who do company employees work for? Who should the employees be loyal to? In the past, they must answer that they work for their company, or superiors. However, today the answer is more varied. The agencies to whom employees disclose information and have explanatory responsibilities have more variation. So interest to whistle blowing is getting higher now.

Several years ago, Chiyoda Life Insurance Company accused the executive director of Chiyoda Life Insurance Company answered to an interview by a magazine and disclosed insider information; and the company sought compensation. The court judged the director should pay compensation to the company. But what the director told to the company was the CEO's misconduct. After that, the company investigated the CEO's misconduct and found he had caused damage to the company and sought compensation from the CEO. Was the action by the executive director really a failing of the duty of loyalty to his company? Did he acquit his duty of loyalty to the insurants? His action saved the company, did it not?

In the process of coverage, I encountered cases that the same officer of public relations of the bank who had denied the misconduct by the bank before the banks collapse turned to accuse the old top management with the new management in the interview. When I encountered these kinds of cases, I sometimes thought who the employees would work for in the future. Not only public relation officers, internal audit officers, and quality control officers but also any employees should think who they owe their loyalty to.

Malfeasance is provided within criminal law. There are few cases where the accused amassed personal fortune. In most cases, the accused avoided his or her responsibility for his or her self protection. The court judged that the latter cases were also malfeasance in these last 10 years.

Sometimes bank lend money to persons who defaulted on the loan that the bank lent. Is it malfeasance? It does not seem to be an action in order to amass personal fortune but seems to be one for saving their companies. However, the court judged it as a malfeasance because it was an avoidance of his or her responsibility for his or her self protection.

Breach of trust to ones organization is one of the essences of malfeasance. In the malfeasance case of financial companies, it is easy to judge if there is a brunch of trust, because one can judge it by monetary damage. However, it is difficult to judge malfeasance cases of public servants or politicians. Politicians often use the excuse that they did it "for the nation" or "for the people." It is difficult to measure if it really contributes to the nation or the people because what is good for the nation depends on the value of the era and it may damage future people even if it contributes to the present people.

Who should engineers practice loyalty and have responsibility to? Dr.Fudano says that they should practice loyalty to their stakeholders; however in the end they should be loyal to the public.

Tasks or missions of professions are sometimes established by laws. For example, the mission of lawyers is established by the law that "Lawyers' mission is to protect human basic rights and to realize social justice," even though they work for their clients. CA should check the clients misconduct and reveal it and correct it when they find it. Their mission is to check and reveal the crime.

Today the concept of compliance is very popular. What should company employees comply with? Who should they work for? Whose satisfaction should they work for? Generally speaking, they should comply with laws, social customs, rules, and norms. But it is not a simple thing. For example, a journalist should keep information source secret according to the journalist ethics. They can gather good information by keeping the promise that they would never tell who the source person is. Even though journalists are asked to speak it in the court, they should not tell it. The journalist may be charged in refusal of testimony. It means that sometimes compliance makes a person break laws. We should comply with generally accepted principles (GAP).

We can say the same thing to the perception of whistle blowing. The word "betrayal" seems to have a terrible image. However whistle blowing and betrayal are similar and neutral as a physical behavior. The difference is in intention. Whistle blowing is to leak a secret for the public interest; on the other hand betrayal is to do it for oneself or the specific authorities. In an autocratic state, a betrayer must have advantage and whistle blower must be punished by the state. Their physical actions are similar but the meanings are different completely.

As shown above, in present society whistle blowing is more easily to done than in the past because the value that whom employees should work for and what they comply with in present society. In present society, whistle blowing is getting a positive image.

4. Emergence of the concept of Organizational Governance

Today it is said that society is lacks governance including corporate governance. From the end of World War 2 and before too, the Japanese economic system was governed with a main bank system with the Ministry of Finance, as the top organization. The Ministry of Finance with the main banks checked, controlled, and governed other banks of lower level and private companies. But the system collapsed in 1990's. Then a lot of misconduct by the companies was discovered, and the companies dismissed. Then instead of the old governance system, the original concept of governance was getting attention.

Companies should have a stockholders' meeting, a board meeting, CEO, and an auditing officer. They constitute a check and balance system in a company (A nation has legislation, administration, and judiciary independently). We should make the check and balance system actually work. They should operate their company with thinking of compliance, and the entire company should manage its risks. In the past, no one thought of that, however most companies do it in the last 10 years.

In addition, many companies began to think that they should act according to the global standard that was made in USA, UK, and so on. In this circumstance, Japanese companies began to establish a protection system for whistle blowers according to the trend of USA and UK who are advanced in the system. Most of the large companies have a 内部通報システム Whistleblowing System as a risk management program, a compliance program, and a governance system. This trend in Japan began after 2000. The system, of safeguards for those who disclose information in the public interest was established in 2003and will become effective in 2006.4 with the background situation mentioned above.

Reality of Whistle Blower-from the Viewpoint of a Medical Doctor

Dr. Uchide Kiyoshi(Kanazawa Univ. School of Medicine, Department of Obstetrics and Gynecology)

1. Introduction

Whistle-blowing, leaking information outside an organization, has a negative image. However, if no one blows a whistle about the unethical behavior of an organization, not only will a hazard spread into society it is also not good for the organization. Whistle Blowing contributes to the organization. If the non-ethical conduct of the organization is corrected, whistle-blowing is unnecessary.

In today's presentation, I will relate why I became a whistle-blower, the background, the summery of events, the reality of being a whistle blower, and a message from a whistle-blower, in that order.

2. Why did I become a whistle-blower?

• 1994.11:New Professor arrived at Department of Obstetrics and Gynecology
• 1995.9:A clinical trial began: high-dose of anticancer drug for ovarian cancer with Neutrogin. The anticancer drug has the side effect of reducing white-blood cells (WBC). Neutrogin is a medicine that raises WBC. The test was conducted by Chugai Pharmaceutical Co.Ltd.
• 1997.12:Patient A entered Kanazawa University Hospital and had surgery.
• 1998.1:Patient A was given high doses of the anticancer drug. Her husband consulted me because his brother-in-law is a friend of mine, saying that A is suffering from side effect. I explained that the protocol of the high-dose in the clinical trial caused that effect. Then patient A and her husband said that they were not informed of a clinical trial with high doses of anticancer drug.
• 1998.6:Patient A decided to leave the hospital because the hospital was trustless. She did not return to the hospital after an overnight stay away from the hospital.
• 1998. 11:Patient A sent a letter to a lawyer that she wanted to sue the hospital.
• 1998.12: Patient A died.

3. What was the clinical trial?

A clinical trial is conducted according to a protocol and a documented procedure. The procedure identifies the organization that gathers the data.

The protocol stated that high doses of CAP & CP would be tested in order to establish the best treatment for ovarian cancer. And, it stated that the test would examine G-CSF in the chemotherapy of high doses of the anticancer drug. G-CSF is a general name of Neutrogin, which is a medicine to raise WBC that are reduced as a side effect of the anticancer medicine.

The protocol of test of Neutrogin said that the object of the test is to examine IntensifyCAP/CP and that they will study the timing of administration of Neutrogin in chemotherapy with high doses of drugs. Chemotherapy with high doses of drugs is harmful to human body because drugs reduce WBCs. So they wanted to test if they could complete the chemotherapy with Neutrogin. This was the objective of the test of Neutrogin.

This is the registration sheet for the clinical trial. Only the patients with enough hepatic and renal function can be a subject of the trial. So doctors write down the information of patients on the sheet and fax it to the registration organization. Then the organization checks if the patient can be a subject. If the case is OK for a subject, the organization assigns a registration number to the patient, and begins the test.

The contact fax numbers of Test 1 and Test 2 are the same. In the sheet of trial 1, the name of the organization "Chugai Pharmaceutical Co. Ltd" is shown. On the other hand, it is not shown in the sheet. It seems strange. Test 1 and Test 2 seem inseparable.

4. Is Informed Consent necessary in clinical trials?

In the court, Government advocates argue that they don't have to obtain informed consent because clinical trials are not treatment but just research. However, in the protocol, they claimed that they would obtain informed consent in a written form before the test.

5. Advocacies by The Plaintiff and The Defendant in The Court

5-1. High Doses of Anticancer Drug

Government advocates argue that the high doses of anticancer drug used were within the doctor's discretionary power. But the protocol stated clearly that high doses of drug would be used in the test.

5-2. Relationship between Test 1 and Test 2.

Government advocates argue that they have no relationship. However, patient advocates claim that they are inseparable tests.

5-3. Is Informed Consent necessary?

In the court, Government advocates claim that they don't have to obtain informed consent because clinical trials were not treatment but just research. However, in the protocol, they claimed that they would obtain informed consent in written form before the test. The treatment with high doses of drugs deviates from the usage written in the appended paper, so the patient advocates argue that they have to obtain informed consent.

The question at issue appears to be about whether doctors are required to obtain informed consent; however there are other moral issues as well. First, the government fabricated the evidence in order to argue that the case was not a clinical trial. Government fabricated the registration sheet. The sheet that Government submitted said that the case is outside of the trial cases because the case does not fit the standard. But I had a copy of the original registration sheet that shows the patient was enrolled in the trial, so I handed in it to the court.

Furthermore, a registration list was made available. The list was of numbers assigned to the enrolled patients. In the list submitted as evidence in February 2000, the Government did not include the name of Patient A. However, I had the copy of original list that included A. Other than A, the list of individuals is the same.

The case lists and registration were altered. In the judgment, they determined that the evidences submitted by the Government were made after the fact.

6. Development of Suit

1999.6:initiation of proceedings to government. The patient and the lawyer expected that the Government would admit its faults more easily than the doctors and that they could acquit the suit readily. They were seeking the possibility of reconciliation.

2000.2:The government submitted the fabricated list of enrolled cases which did not include Patient A, and it argued that patient A was not included in the trial. Whereupon I submitted the copy of the original list that included patient A.

2000.9:I proposed reconciliation to the hospital director because patient A and her lawyer desired it. Patient A and her lawyer wanted only that they would make clear how the hospital intends to exercise its responsibility and that the hospital would admit their faults and apologize. However the director said that we proposed the reconciliation because of a weak position. Both Patient A and the attorneys explained that they did not dislike the hospital but wanted the hospital to take responsibility and treat patients as humans instead of guinea pigs. After that, we began to push the Neutorogin and the treatment as a single issue.

2002.5and7:I and patient A's doctor were called to the court for examination as witnesses. In the suit, the Government advocated that conflict was between Doctor K and myself, and was not an informed consent issue. The Government argued that the advocacy by the patient was made up entirely by me.

[strange reports]

2001:A famous professor handed in a strange report to the court. It said that the clinical trial of CAP&CP had already finished in 2000 when A had the treatment with anticancer drug and so the study by the hospital was not a clinical trial but simply independent research.

2001.6:About the trial for Neutrogin, Prof.Miyamoto submitted a report that the trial was not a clinical trial. On 6.28, a Professor working in Yamaguchi Univ. submitted a strange report that the chemotherapy with high doses of the anticancer drug and with Neutrogin had been within conventional medicine in 1997.

In spite of those reports, the court judged that the doctors had a duty to obtain informed consent in any case that they conducted a trial or research even if the study wasn't a clinical trial.. The government appealed the court ruling.

[The time of study also strange]

In addition, there is a strange statement concerning the period of research. In the evidence the defendant submitted, the term of the study was also strange. It says the term of Neutrogin trial was from 1996.6.1 to 1996.9.31. However, the date on the registration sheet for the Neutrogin is 1996.1.13. They had some other strange dates that appeared to be fabricated. However, the High Court did not make a judgment about fabrication.

The process of the suit was shown above. The Nagoya High Court decided that Doctors should obtain informed consent before tests and human related research.

7. After that

[Informed Consent Inquiry Committee]

2005.6.12:Asahi Newspaper reported that Kanazawa Univ. Established an Informed Consent Inquiry Committee.

January 26th:I submitted a request to the Univ. chairman. In the request, I asked them: 1) to investigate whether the doctors obtained informed consent from patients enrolled other than A and to have some action for them if they did not obtain it as soon as possible, and 2) to disclose why they fabricated the evidence since it was judged as fabricated. ･ Sep.20:I made the application again because they did not provide a response. I asked for an early response as required in the safeguards law for those who disclose information in the public interest

Oct.14:The committee responded. They said that 1) the matter was under investigation and 2) that they could not answer anything on because the suit had not finished yet. 2006.1.17: We had a public release that Kanazawa Univ. established the Informed Consent Inquiry Committee, which consisted of 5 members, and of which head is the vice president of the university, Prof.Nakamura. The committee concluded that adequate informed consent had not been obtained from patients. That was a good conclusion in my opinion. The committee proposed establishing disciplinary structures, establishing procedures, providing IC education, and compiling written procedures; but the contents are insufficient. There are many problems, first, it is not clear who assumes responsibility for the committee because the member list of the committee is not released. Second, it did not mention the Neutrogin trial. The usage of Neutrogin in the clinical trial was outside of the predetermined usage which means usage in the trial would violate drug legislation. Thirdly, the committee did not mention the fabrication. The release was not enough.

[the harassment investigation committee]

My statement to the Harrassment Committee included an advisory that I should retire from Prof.Inoue and materials submitted during the lawsuit. The lawsuit statement alleged that other members of the medical school were fed up with me and the suit had been brought by me to prevent my dismissal from the school and there were questions about when I had consulted the patient.

After the scandal, the numbers of surgery to which I was assigned decreased and denial for permission to give lectures outside of the University increased. I suffered a cut income, all forms of harassment. The harassment inquiry committee judged that the encouragement of retirement was harassment. The committee concluded that it could not judge about the other things. The committee said "Please do not release the conclusion in order to protect the privacy of people who were investigated. If you release it you may be punished for defamation". I felt some anger about this because I cannot say anything to anyone if I have some dissatisfaction with the committee's conclusion.

8. What I Want To Say Now As A Whistle Blower

I propose reduction of time for suit in Japan. For our case, it took 3 years and 8 month sto get the judgment by the district court.

The court judged that doctors must obtain informed consent if a patient would like to enroll in the clinical trial prior to the trial; however it ruled that doctors do not have to tell the patient and obtain informed consent on the contents of the trial such as the quantity of anticancer drug and why doctors use Neutrogin. The contents of the treatment and trial are within doctors' discretion. Information on the contents is too difficult for the patients to understand. I do not agree to the latter half of the judgment.

I propose to toughen the penalty for fabrication of evidence. In a medical suit, if doctors fabricate the patient records, the patient cannot do anything to it and have no other choice than giving up. A lot of plaintiff patients have suffered from fabricated patient records. So I think the fabrication of patient records is more corrupt than the fabrication of other documents.

I want the national government and the university to act more sincerely toward whistle-blowers. The investigation by the informed consent inquiry committee was insufficient. And the harassment committee only suggested not doing it in a written form. The system of safeguards for those who disclose information in the public interest will become effective from this April. "The objective of disclosing information by whistle blowing is to correct misconduct by an organization. If the organization has self-cleansing capabilities, we do not have to blow whistle.

Clinical trials are very important in order to make good drugs. The drugs from questionable clinical trials without informed consent may also be questionable and may induce disease. So we must correct the system of clinical trials, including informed consent.