Healthy Skepticism Library item: 13411

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Publication type: news

Tamura Y, Tatebayashi M, Takada M, Masuda K.
Medical guidelines seen ailing / Donations from drugmakers call impartiality of research into question
The Daily Yomiuri, The Yomiuri Shimbun 2008 Mar 31
http://www.yomiuri.co.jp/dy/national/20080331TDY03103.htmhttp://

Full text:

The trustworthiness of certain medical care guidelines has been called into question after it was learned that the doctors involved in drawing up the guidelines received donations from pharmaceutical makers.

The national and public university doctors were found to have received donations from pharmaceutical firms that produce and sell drugs for disorders and ailments covered by the guidelines.

Meanwhile, questions also are being raised as to whether researchers who have received corporate donations can remain impartial.

The doctors who mapped out the guidelines for disorders including metabolic syndrome and high cholesterol, received far more cash than other doctors.

Some experts are skeptical about the guidelines due to their low thresholds, which are capable of categorizing healthy people as being sick and in need of medication.

The standard for determining whether a person has high cholesterol is set in line with Japan Atherosclerosis Society guidelines, which defines a total cholesterol count of over 220 as being high. This compares to the U.S. level of 240.

Compared with this higher level, patient levels double if the figure of 220 is used.

Tomohito Hamazaki, a professor at Toyama University’s Faculty of Medicine, said that if the lower figure is used, half of all middle-aged and elderly women would be diagnosed as having high cholesterol.

“The number of patients has been increased unnecessarily, which resulted in an excessive use of drugs,” he said.

Last year, the society removed the total cholesterol level from the standard and announced a new standard based on levels of low-density lipoprotein cholesterol, known as bad cholesterol.

However, Hamazaki said the figures used to replace the total cholesterol level are still stricter than the U.S. levels.

A waistline of 85 centimeters or more is one of the standards used to determine male metabolic syndrome—an accumulation of fat around the internal organs—but this figure is much lower than the U.S. standard of 102 centimeters or more.

Yoichi Ogushi, professor at Tokai University’s School of Medicine, said an 85-centimeter waistline is almost average for Japanese men.

“Men with waistlines between 85 centimeters and 90 centimeters have the lowest death rate, according to some statistics. If the current standard is utilized for medical checkups, many people will be asked to attend hospitals and there is a high possibility that healthy people will be given drugs,” he said.

Yuji Matsuzawa, a professor emeritus of Osaka University who participated in drawing up the standard for determining metabolic syndrome, argued that the standard was designed to improve lifestyles and keep people in healthy condition.

“It would reduce overprescriptions,” he said.

Corporate donations to universities have increased since 1998 when a law was introduced to promote the transfer of technologies from universities and research institutes.

The law was designed to encourage the practical use of research results.

About 38 billion yen of the research funds provided to the medical field by the Education, Science and Technology and Health, Labor and Welfare ministries in fiscal 2006 was allotted to national and public universities. However, corporate donations in the same year totaled about 26.2 billion yen, according to a survey conducted by The Yomiuri Shimbun.

Financial irregularities involving doctors and pharmaceutical companies came to light after it was claimed that the influenza drug Tamiflu caused abnormal behavior, such as inducing suicidal tendencies.

A health ministry study team examined the causal relationship between the alleged Tamiflu-related incidents and the drug, but three of the professors on the team were found to have received donations totaling 76 million yen from the pharmaceutical company that made the drug.

The ministry removed the three professors from the team to ensure the impartiality of the probe.

The ministry later decided that—starting from May—members of government panels set up to study the safety of new drugs are not allowed to take part in discussions or make decisions if they have received donations of more than 5 million yen from a related company.

However, Rokuro Hama, a doctor and the chairman of the Japan Institute Pharmacovigilance, a nonprofit organization that monitors the side effects of medicines, criticized the ministry’s stipulation, saying restrictions on the size of donations are not strict enough and information disclosure is insufficient.

The ministry has demanded that professors report to their universities how much they receive in donations, but as of April last year, only 65 percent of national universities and research institutes had drawn up guidelines requiring their professors to do so.

Akira Imada, a visiting professor at Kobe University, said tie-ups between universities and companies often result in conflicts of interest.

“It’s difficult to say that such relationships undermine the impartiality of all research, but it’s the kind of connection that ordinary people may raise questions about. It’s therefore important to have rules and regulations,” he said.

Toshio Ogihara, a professor emeritus at Osaka University and chairman of a panel devising guidelines for treating high blood pressure, said doctors who become panel members usually are affiliated with several clinical tests.

“Even if they receive donations, it doesn’t mean they would give special treatment to certain companies. If all such doctors are removed from guideline-making panels, such panels can’t be established,” he said.