Drug Promotion

Drug Promotion

US companies push psychotropics

While direct-to-consumer advertising of prescription drugs is legal in the US, a number of companies are pushing the limits of ethical marketing. For example, one drug company was recently found to offer university scholarships to patients with schizophrenia who switched to their new antipsychotic medication. Critics feared that doctors would feel strong pressure to prescribe the drug and patients might gain false hope that they can bear the demands of university learning. As a measure of its apparent success, the drug danzapine (Zyprexa) earned US$550 million in its first year on the market. Other promotional efforts include Eli Lilly's providing educational material and a social structure for schizophrenic patients and their families.

In defence of such measures, the industry has responded "This is the information age, and more information empowers patients to have more meaningful conversations with their doctors about cures and treatments." Sidney Wolfe of the US group Public Citizen, has disagreed with this view emphasising that many mentally ill people lack sound judgement and are particularly vulnerable to such promotion.

Recently, the Journal of the American Medical Association published a study suggesting that up to 80% of prescriptions for antidepressants are unneeded and are given to people who are not actually clinically depressed.

(British Medical Journal website, http://www.bmj.com/archive/7132/7132n7.htm )

From a series of Drug and Therapeutic Bulletin cartoons by Merrily Harpur

Hidden conflict of interest among researchers?

Biomedical researchers may not always be the objective scientists one presumes, concluded a study presented at the American Association for the Advancement of Science. Sheldon Krimsky, an economist at Tufts University in the US, explored the financial interests of researchers by examining 789 medical articles published by 1,105 researchers working at institutions within that state in 1992. He found that in 34% of the studies (267) at least one of the involved scientists had a financial interest in the reported results. This was due to the fact that they held a patent involved in the work or worked for a biotechnology company conducting the research or served on such a board. However, none of the papers admitted any financial interest for those involved. Such close ties between researchers and the companies that sponsor the research raise serious concerns that research results that could harm the financial potential of the sponsors might be delayed or even hidden, regardless of their importance for public health. Krimsky proposed that the 34% figure was probably too low as he was unable to check if the researchers owned stock in the involved companies or had received consultancy payments. In his presentation, he pushed for greater openness of such financial ties.

(Internet Patent News Service)

Belgian Prozac critic calls for more evidence of drug's safety

Replying to a Belgian doctor's inquiry about Prozac possibly causing "depersonalisation" (one of the many possible symptoms of psychosis), the drug's manufacturer, Eli Lilly, stated in a letter that double-blind studies conducted against placebo in 5,600 patients have shown that one patient in 100 to one in 1,000 experiences depersonalisation and that other psychotic events have been recorded, such as hallucinations and anti-social reactions. However, the company then goes on to state this "doesn't prove anything."

A long-standing critic of Prozac's marketing methods, Dr. Robert Bourguignon, disagrees with the company's conclusion, saying it certainly proves the need for more tests on the drug. He explains "Say airplane manufacturer Boeing sent a similar letter to a client, stating that tests could or would show one in 100 of their airplanes is defective. The obvious move would be to thoroughly check those planes in order to ascertain whether or not those tests were accurate. It would be unimaginable for Boeing not to check and simply say 'Those tests don't prove anything. If you think our airplanes could be defective, prove it.'" Bourguignon believes the manufacturer (not the government or doctors) has the responsibility (and the money) to carry out further tests.

Bourguignon sets out his arguments on the misleading ways Prozac has been marketed as a wonder drug with few serious side effects in his new book Le Dossier Prozac (The Prozac File). As the first French-language book to delve into the issue, he examines controversial side effects blamed on the drug and the manufacturer's efforts to clear the drug's reputation. He also vividly describes questions raised in the Belgian Parliament about the drug's safety and his own efforts to conduct a study on possible side effects that landed him in court following a suit brought by Eli Lilly. (He won the case in court. See HAI Lights, July/August 1997.)

Bourguignon and colleagues working to make prescribers and consumers more aware of the drug's possible side effects have already met with success. In June this year, the Belgian Minister of Health announced in Parliament that the drug's label would be changed for both doctors and consumers to warn about the risk of psychotic effects when taking it.

To order a copy of Le Dossier Prozac by Dr. Robert Bourguignon and Jean-Frederick Deliège, contact: Editions Luc Pire, Rue Lesbroussart 76, 1050 Brussels, Belgium, tel: (+32-2) 640-8596, fax: (+32-2) 646 7222 or e-mail: editions-luc-pire@emedia.be.

Viagra mania...

After breaking all records of early week sales, (20,000 per day in some estimates), one US radio station added a new promotional twist. Radio station KGO in San Francisco held a contest "30 Pills and a Month of Thrills" offering five contestant winners a prescription for a one-month supply of sildenafil (Viagra). The catch? Contest hopefuls must describe in 25 words or less why the station should pay for the prescription.

Viagra sales have also been steady on the Internet. The drug is now available in several countries including the US and Brazil and soon the European Union. There have been reports of it being shipped into others and distributed by doctors. One report stated that smuggled, single pills are selling on the black market for US$22 in South Korea and up to US$59 in Taiwan as compared to US$10 in the U.S.

After widespread press hype about the new "lifestyle" drug, reports have started to filter in about side effects and deaths attributed to the drug's use.

(E-Drug Message, 7/7/98)

...and Viagra concerns

Public Citizen has called on the US Food and Drug Administration (FDA) to change the label for sildenafil (Viagra). The organisation believes users should have more information about possible adverse effects on vision and its risks when used with certain drugs used for treating high blood pressure. It also wants to ensure that the drug's accompanying information states it is contraindicated for people with the same conditions or diseases that were excluded from the clinical trials.

Vision has been found to be affected by the drug because it inhibits an enzyme which is found in different parts of the body including the eye. Some scientists believe changes in this enzyme can lead to retinal degeneration and possible loss of vision. Currently, the patient package insert notes that users may experience vision disturbances including a color tinge, blurred sight and increased sensitivity to light.

Public Citizen has also emphasised that a number of drugs are known to cause sexual dysfunction in both men and women. It advises that dosages of drugs known to cause this problem should be reduced or alternative drugs that do not cause sexual dysfunction should be tried before Viagra is prescribed.

The full text of Public Citizen's petition can be found on the Internet at: http://www.citizen.org/hrg

IDA turns 25

In late 1997, the International Dispensary Association (IDA), a non-profit group offering medical supplies and drugs, celebrated its 25^th anniversary with a symposium "25 Years of Essential Drugs: The Challenge Remains". Held at the Royal Tropical Institute in Amsterdam, speakers including HAI members Catherine Hodgkin, Graham Dukes, and Richard Laing. The full proceedings of the meeting will be published in an upcoming issue of the International Journal of Risk and Safety in Medicine. To receive a copy, contact IDA, P.O. Box 37098, 1030 AB Amsterdam, The Netherlands, tel: (+31-20) 403 3051, fax: (+31-20) 403 1854 or e-mail: ida_sale@euronet.nl

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