Separation of Fact From Fiction

chapter_2 lesson_3
Read Chapter 2 and Lesson 3.In follow-up email, I am sending you a peer reviewed PDF full text (Baby Think It Over)This study is dealing with whether baby simulators are effective in pregnancy prevention.  It is a study with methodology and subjects.

1. In 500 words, summarize and relate to the chapter and lesson.  Write the citation using APA format.  Be sure you use APA references as you do for all assignments.
2. Be sure you discuss the methodology they used including sample selection, instruments and results 

Lesson 3: Separation of Fact From Fiction

 

Objectives

· Define peer review

· List the characteristics of an intelligent consumer

· Explain why people are vulnerable to quackery

· Explain how the scientific method is used to determine health-related facts

· Explain how to evaluate sources of health information

· Explain and analyze the issue of conflict of interest in clinical research

It is difficult to be an informed consumer in today’s world with all the sources of information that bombard us daily. The first two chapters of our text, Barrett,

Jarvis, Kroger and London (2007) review some of the major issues and list some

characteristics of an intelligent consumer. Test your consumer IQ and take the

consumer health profile on page 13. You may post your comments about these assessments on the discussion board.

 

The Scientific Method

In Chapter 2 there is a discussion about how to find reliable sources of health

information. The authors have rated some popular magazines and other periodicals.

Also in Chapter 2 there is an important discussion about the scientific method. This course is based on the assumption that the scientific method is valid. In the area of consumer health, services and products must be studied by following the scientific method in order to know if they are of any use. Health services and products must be subject to scientific scrutiny.

An understanding of the scientific method is crucial in so many ways. It helps us

separate fact from fiction. It can also give us an approach to problem solving and therefore, critical thinking. It helps us to ask questions about new treatments and products. It gives us a skeptical, or should I say, questioning view about what we are told. Knowing about the scientific method makes us want to see the proof before we accept a statement.

In epidemiology we learn about various ways to go about studying the relationship

between a factor (like cigarette smoking) and a disease (like lung cancer). When scientists begin to study a relationship like this they need to have a “wait and see” attitude about the findings. They need to go into the research with no bias or at least put aside that bias. When the cigarette companies funded the research they found no relationship between cigarettes and lung cancer. When the government began to fund the studies they found a very strong relationship. It is important to know where the funding is coming from in the various studies. The most reputable journals have a policy on conflict of interest stating that authors must disclose any

conflict of interest that might taint the study. That is also why articles are peer reviewed; so that other scientists can check their colleagues’ work.

 Conflict of Interest in Health Research

There has been a great deal of discussion about the effect of corporate funding of health research lately. The reason being that since the mid-70’s government funding for health research declined and private funding increased. (Blumenthal, 2003) The primary areas of concern are drug and medical device research. Drug and medical device companies fund academic medical centers to study drugs and devices in order to get FDA approval. Clinical investigators (physicians and other scientists) who conduct these studies have, over the years, become increasingly dependent on those companies for their income. Many have profited handsomely.

The “perks” that physicians have by being associated with drug companies range rom small to major rewards. Drug company representatives shower residents with small gifts and free dinners. Sometimes the gifts aren’t so small and sometimes the dinners are at conferences in exotic places. Probably more worrisome is that researchers sometimes have financial investments in the companies whose products they are researching. In 1980 the passage of the Bayh-Dole Act encouraged academic institutions, when funded to do research by the federal government, to patent and license new products developed by their faculty and to share royalties from these discoveries. (Angell, 2000)

I think you can see the problems that are generated from a close connection between research and making money. In the references are listed some articles that discuss and debate this problem. In summary, I would characterize the consensus this way:

1. We (i.e. researchers) agree that our work should not be tainted by the profit-making incentive.

2. We also know that these days private industry is a major source of funding for research.

3. If we are to do research we must accept funding from private industry. That’s where the money is!

After #3 there is no longer consensus. There is a great divide over what to do about potential conflicts. Every university that conducts research must have a policy about financial associations for researchers. Harvard University in the past prohibited researchers from having more than $20,000 worth of stock in the companies whose products they are researching. (Angell, 2000) That is being revised to a larger number. Harvard and other schools say that if they have very tight restrictions, they will not be able to attract top researchers. They are “between a rock and a hard place.” They want to maintain their reputation for academic excellence and objectivity but if they are to maintain that reputation they need to bring in top people and many top people want to make money.

The other issue is the decrease in funding to academic medical centers where most research is conducted. Due to the 1997 Balanced Budget Act Medicare reimbursements to these institutions have declined. Medicare used to factor in the cost of training physicians and conducting research into their rembursement formula. That is no longer the case. (Angell, 2000)

 

Examples of the Consequences of Corporate Research Funding

It’s hard to get a handle on the extent of this problem. I am sure that there are many researchers who are funded by private corporations to do research who have the highest standards and integrity. But it is difficult to maintain these standards. A few examples:

 

1. In a letter to the New England Journal of Medicine, a physician from the University of Mississippi writes:

As an academic psychiatrist and neurologis, I have been invited by pharmaceutical companies on a number of occasions to educate my colleagues on such topcis as depression and dementia. In my attempts to present balanced information, I deluded myself into thinking I was educaing physicians, and not being swayed by the sponsors.

Several months ago, however, I wrote a series of case resport reflecting muy expreience with the side-effect profile of a certain medication. The problem was that the profile was less favorable than that of medication made by a competitor of one of the companies for which I often spoke. My invitations to speak suddently dropped from four to six times per month to essentially none. As a father of five children, I began to feel uneasy. Had I done something wrong? By presenting my clinical experience, was I now depriving my family of a source of income?

I found myself seeking out representatives of the company to let the know I was still “on the team.” I began to worry that I was not presecribing enough of their medication. I was amazed at how I had become seduced by pressure to kind to the sponsor’s product.

This experience has opened my eyes, and I will proceed with caution – that is, if I am ever invited to be a speaker again. (Norton, 2000)

 

2. Bodenheimer (2000) points out that sometimes researchers funded by drug companies will compare a new drug to an insufficient dose of a competing product so that the new drug will seem better. He also states that researchers, in order to come out with a result that they want, will test the drug on a younger and healthier population than the population that will actually use the drug.

Drug companies have been known to supress research if it does not come out the “right” way.

In 1996, Canadian investigator Nancy Oliveri and colleagues found that deferiprone, used to treat thalassemia major, could worsen hepatic fibrosis. Apotex, the sponsoring company, threatened legal action if Olivieri published the findings. The contract between Apotex and Olivieri forbade disclosure of results for three years after the study without the company’s consent. An article was eventually published. (Bodenheimer, 2000)

 

3. A researcher from the University of California conducted a study for the manufacturer of Synthroid to see if it performed better than the competing thyroid medications. The researcher found that it did not perform any better and the drug company refused to allow the results to be published citing a clause in the contract with the researcher that stated that no information could be released without their permission. An article was finally published seven years later. (Bodenheimer, 2000)

 

4. In another case two clinical trials of the same drug were conducted. One trial resulted in less favorable results than the other. The results of the less favorable trial were never published despite the protests of the researcher. (Bodenheimer, 2000)

 

Bodenheimer also discusses other practices that are important to note:

 

1. A growing trend is to have a professional medical writer write the article on the study. These ghostwriters receive a packet of material and sometimes are instructed to insert a paragraph that is favorable to the company’s product. The writer is not listed as an author.

2. Because academic medical centers sometimes take a long time to conduct research, a new type of organization has been created. CRO’s are profit-making entities that employ scientists and offer a variety of services. A drug company might contract with a CRO to carry out a study that was designed by others or they may ask the CRO to do everything, from start to finish. In 2000 CRO’s received 60% of the research grants from drug companies compared to only 40% for academic medical centers. (Davidoff,DeAnelis, Drazen, Hoey, Hojgaard, Horton et al., 2001)

3. Another profit-making entity that has been created is the SMO. This organization consists of networks of physicians who can provide patients for the clinical trials.

 

Medical Journals

What about the journals that publish these studies? Well, the debate has been hot and heavy. To summarize the debate again:

1. It is essential to publish unbiased research.

2. A substantial amount of research is funded privately where there may be conflicts of interest.

3. If we refuse to publish research where there is a conflict of interest we may have nothing to publish.

4. If we refuse to publish, authors will take their articles to our competitors.

All responsible journals have developed requirements for disclosure to financial interests. The New England Journal of Medicine (NEJM) forms can be found below. Again, what should the limit be on amount of money that the researcher is making? NEJM requires that authors must report:

· Consulting feeds or paid advisory boards (per year, for the past two years or known future)

· Equity ownership/stock options (publicly or privately traded firms)

· Lecture fees when speaking at the invitation of a commercial sponsor (for the past two years or known future).

· Grant support from industry

· Grant support from nonprofit/government entities

· Patent and/or royalties

· Fees from serving as an expert witness

The problem is, ofcourse, how do you monitor whether the author is reporting the truth? If they don’t they could risk their professional reputations if it is exposed. On the other hand, what are the chances of being exposed?

 

An Example

Marcia Angell, former editor of the NEJM, wrote an editorial during her tenure about this issue. She commented that an article by Keller (2000) that was published in NEJM represented the challenges that medical journals are facing. Most of the authors (and there were 13) had substantial financial ties to the drug industry. It was impossible to publish all of the ties. So the following statement was written:

Our policy requires authors of Original Articles to disclose all financial ties with companies that make the products under study or competing products. In this case, the large number of authors and their varied and extensive financial associations with relevant cojpanies make a detialed listing here impractical. Readers should know, however, that all but 1..of the 12 principal authors have had financial associations with Bristol-Meyers Squibb-which also sponsored the study-and, in most cases, with many other companies producing psychoactive pharmaceutical agents. The associations include consultantcies, receipt of research grants and honorariums, and participation on advisory boards….2 are employees of Bristol-Meyers Squibb. (Angell, 2000)

In this case they referred readers to their website for a detailed listing of the financial ties.

The other problem that Angell had with this article was that she had trouble finding someone to comment on it. Everyone she asked had financial ties to the drug industry. She wanted someone to do a commentary on the article who was an expert but did not have those ties. She finally found someone but the difficulty raises another issue. When journals are peer-reviewed and peers all have similar financial interests, how can they objectively review someone else’s research?

 

Another Even More Important Problem

Angell also points out that if a good portion of the research money comes from drug companies, the result will be that we will know a lot about drugs but it will not enhance our understaning of the underlying causes of disease. Who will fund a non-drug solution to the problem? Government should be funding this type of research but there has been a decline in funding for government as a whole in recent years. How will we learn about prevention if the research is directed toward drug treatment? We won’t.

 

Solution?

A number of solutions have been suggested:

· Prohibit drug company representative from coming into the hospital to promote their products.

· “House officers should buy their own pizza.” (Angell)

· Stronger conflict of interest guidelines should be adopted by research institutions and medical journals.

· The corporate contracts with researchers should include an assurance that researchers will be independent to conduct and publish the results of their studies.