AP Business WriterTue May 24,12:49 AM ET
Pfizer Inc., GlaxoSmithKline PLC. and Merck & Co. are “making a mockery” of efforts to create more transparency in drug clinical trials, according to a prominent medical journal editor.
Dr. Jeffrey M. Drazen, editor-in-chief of the New England Journal of Medicine, said the companies are not providing enough useful details in their posting on a government trial registry and that their reluctance to provide meaningful information may hamper their ability to have their studies published in important medical publications
Last September, the members of the International Committee of Medical Journal Editors said they would not publish any studies that are not registered in a public database as they are launched. Drazen’s comments came as the editors delivered more details about what they expect from pharmaceutical companies. The group is asking for 20 disclosures, including what each study is designed to evaluate, how many patients will be studied and who is funding the research.
Drazen based his comments on a review of the information drug companies posted on www.clinicaltrials.gov., which is run by the U.S. National Institutes of Health. He said the review was conducted by Dr. Deborah Zarin of the NIH at the request of the committee.
“They (the three companies) are giving nonsense details,” Drazen said in an interview on Monday. “They are written in a way that they are trying to hide what they are doing.”
Merck spokeswoman Janet Skidmore said the company didn’t agree with Drazen’s characterization of its entries on the government web site.
“We have done everything we can to expedite medical information and enhance transparency,” Skidmore said.
Glaxo spokeswoman Mary Anne Rhyne said the company has listed 55 ongoing trials on the NIH site as well as 400 studies on its own site. Rhyne said the company intends to supply journal editors with all the trial protocols along with any manuscript for publication so the editors can see the article accurately represents the study conducted.
Pfizer didn’t return calls for comment.
The editors created the policy after some drug companies were accused of stifling negative data from clinical trials. Last year, New York state Attorney General Eliot Spitzer sued GlaxoSmithKline for suppressing unfavorable studies of its antidepressants. He also asked Forest Laboratories for information about studies of its antidepressants.
Meanwhile, trial lawyers have accused Merck of hiding negative information about Vioxx, the pain killer it withdrew from the market last year because a study showed it doubled patients risk of heart attack and strokes.
Zarin said first she looked at whether pharmaceutical companies were giving drugs a distinguishable name. She said a name is crucial because it allows editors, patients and doctors to track a medicine’s progress through the trial process.
“You need a name to search a data base,” said Zarin. “You wouldn’t know if you were missing something if the drug doesn’t have a name you can search.”
Indeed, the problem that has vexed editors is that they can’t readily find out if negative data exists when they are only given glowing manuscripts. The registry is supposed to give editors, doctors and patients a complete picture of a drug’s development but that would be difficult if a medicine can’t be tracked through its name.
Of the over 400 companies with trials listed on the registry, only 5 neglected to list specific names, often calling the products simply “investigational drug”, Zarin said.
Zarin said that 90 percent of the time Merck didn’t provide a name. Glaxo didn’t provide a name 53 percent of the time while Pfizer lacked a name 36 percent of the time. The other two companies were Eli Lilly & Co. and Bristol-Myers Squibb Co. but they lacked names less than 5 percent of the time.
Drazen said another problems with the information submitted by three companies included a failure to clearly outline the primary and secondary outcome measures of their studies. For example, a study should say that it is attempting to see if a drug can lower heart attacks over a year.
However, Zarin noted that most companies didn’t provide such data and that it wasn’t required by the NIH. Since October, there is space for companies to include such information, however.
Drazen said that Lilly and Abbott Laboratories are “90 percent in compliance” with what the editors are expecting. Zarin gave high marks to Novartis for the quality of its disclosures.
Drug companies are legally required to register trials dealing with serious or life-threatening diseases to the NIH site. But since the controversy over trials, companies have been listing various types of studies on the site. Some companies have also begun listing the trials on their own web sites.
Earlier this year, four major international pharmaceutical associations agreed that companies should provide submit information on their trials to a public registry. The U.S. association, the Pharmaceutical Research and Manufacturers of America, recommended its members list trials on the NIH site beginning in July.
The editors have given the companies until September 13, 2005 to register ongoing trials. It applies to new trials starting on or after July 1, 2005.
Drazen said that if the companies don’t comply, editors will refuse to publish their studies. He said that other medical journals had adopted the registry standards of the international committee so companies that don’t comply may find their choice of publication venues is limited. Drug companies often use studies published in medical journals in their marketing.
“We think they will want our stamp of approval,” Drazen said.
AP Business WriterTue May 24,12:49 AM ET