From the Boston Globe comes this story of a drug company's aggressive effort to turn patients into lobbyists.

Ward Wetherell is used to receiving health tips about such topics as 'good' cholesterol from Pfizer Inc. , the world's largest drug company. This month, however, the glossy brochure Pfizer sent to Wetherell's home in Needham tackled a national policy issue days after a crucial House of Representatives vote to lower prescription drug prices.

Congress needs to hear that market forces, not the government, should control prices, said the 'For Living' brochure, which included form letters addressed to Wetherell's representatives in Congress. 'History reminds us that when the government interferes in a free market and controls prices, the results can be dangerous,' it warned.

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Quite a few stories have appeared of late about conflicts of interest affecting the US Food and Drug Administration (FDA). Some are worth updating.

Former FDA Commissioner Crawford to be Sentenced

We posted about the guilty plea provided by former FDA Commissioner Lester Crawford for lying about his family's ownership of stocks in food, beverage, and medical device companies regulated by the FDA. According to the Associated Press (via AZCentral here), Crawford is now about to be sentenced.

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Today's issue of Morbidity & Mortality Weekly Report includes the piece, "Use of Mammograms Among Women Aged >40 Years --- United States, 2000--2005," which describes findings from the Behavioral Risk Factor Surveillance System (BRFSS) telephone survey indicating that the rate of getting mammograms reported by U.S. women has declined. Based on the surveys, the percentage of women age 40 or older reporting having had a mammogram in the past two years decreased from 76.4% in 2000 to 74.6% in 2005; the National Cancer Institute recommends that all women in this age group have a mammogram every 1-2 years. While this seems like a small percentage change, it was considered statistically significant. According to a Washington Post article on the findings, "The decline of less than 2 percentage points may seem small, but it could be terribly significant, Lichtenfeld [of the American Cancer Society] said. But if you consider that about 80 million U.S. women should be getting a mammogram every year, it means more than 1 million fewer women are getting the screening test, he said."

The Healthy People 2010 (a set of national health objectives) recommendation of having 70% of these women reporting mammogram was still met, despite the decline. The MMWR piece describes several limitations of the study, such as small sample size, representing only certain states, lack of confirmation with medical records, and overestimation of breast cancer screening by including mammograms that were done for reasons other than routine screening.

Last summer we posted about the Healthcare Research and Development Institute (HRDI). HRDI is a for-profit owned by a number of the top executives of some of the US best known hospital systems and academic medical centers. According to an article in the NY Times, HRDI gives a limited number of drug, device, and biotechnology companies access to these executives, for a stiff fee.

According to yesterday's NY Times, the Connecticut Attorney General, Richard Blumenthal, just obtained a settlement from HRDI that calls for the company to pay a $150,000 fine, and disband as a for-profit company. A digest of the story, edited and re-ordered, is below:

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We previously posted (here, here and here) about allegations in a New York Times series that Eli Lilly and Company had used questionable marketing tactics to promote its atypical anti-psychotic drug Zyprexa (olanzapine), and especially that the company had suppressed information suggesting that the drug had more adverse effects than previously reported, and then how the company tried to restrict publication of the internal memos on which these allegations were based.

The New York Times has continued its reporting on the subject,

It all began with Dr. David Egilman of Massachusetts, who was a consulting witness in ongoing litigation against Lilly. Dr. Egilman had in his possession a trove of internal Lilly documents - not all of them flattering to the company - sealed by the court as part of that litigation.

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We previously posted (here and here) about allegations in a New York Times series that Eli Lilly had used questionable marketing tactics to promote its atypical anti-psychotic drug Zyprexa (olanzapine), and especially that the company had suppressed information suggesting that the drug had more adverse effects than previously reported.

The latest issue of the British Medical Journal featured a news article by Jeanne Lenzer about how Lilly has tried to suppress publication of the internal memos on which the Times based its series. [Lenzer J. Drug company tries to suppress internal memos. Brit Med J 2007; 334: 59. ]Lenzer wrote,

The drug maker Eli Lilly instigated legal action against a number of doctors, lawyers, journalists, and activists over hundreds of internal corporate documents and emails said to have been obtained by them regarding the antipsychotic drug olanzapine (Zyprexa). Eli Lilly obtained a court injunction on 29 December ordering 16 individuals and organisations to stop publishing the documents and to remove any copies posted on the internet.

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The case of the BMJ news article about missing Prozac documents, which we have discussed before, just gets curiouser and curiouser.

Today, the NY Times published a news article that seems to suggest something big went wrong at the BMJ. "Dispute Puts a Medical Journal Under Fire," by Barry Meier, asserted "the staid, usually methodical world of medical journals could suffer its own black eye," and that "the incident may prove to be a messy one for the BMJ."

But Meier produced little evidence to support these apparently quasi-editorial conclusions.

Let's go back to the original BMJ article. Its key assertions were that

"confidential drug company documents ... went missing during a controversial product liability suit more than 10 years ago;" "the documents appear to suggest a link between the drug fluoxetine (Prozac), made by Eli Lilly, and suicide attempts and violence;" and "Eli Lilly officials were aware in the 1980's that fluoxetine had troubling side effects and sought to minimise their likely negative effects on prescribing."

Meier's NY Times news article reported that Eli Lilly vigorously contested the content of the BMJ article. Specifically, its lawyers "notified the publication that the company considers the article to be 'inaccurate and defamatory,' asserting that the records were not missing and that all their relevant data had been previously submitted to the FDA. Also, Lilly issued an analysis last week of the 52 pages of records that the BMJ had received, which the company said supported its claims." Yet Meier's article does not give any specifics of how Lilly disputed the main points of the BMJ article. So apparently Meier concluded that the BMJ deserved a "black eye" just because Lilly did not agree with it. Why he seemed to think that Lilly was right and the BMJ was wrong, especially without seeing the documents in question, is not clear.

Furthermore, other statements by Lilly, available on its web site, muddy things further.

Lilly's press release of January 4, 2005, asserted that the "documents reveal no new clinical or scientific information," and that "the information in the documents has already been shared with the U.S. Food and Drug Administration (FDA) and other regulatory bodies, published in medical journals, or produced through legal discovery and available for use at various legal trials for more than a decade." Of course, this did really address the BMJ's assertion that specific documents went missing. Furthermore, information produced through legal discovery may not be sufficiently available to physicians to affect their prescribing decisions.

The second Lilly press release of January 13, 2005, contains an assertion by Lilly CEO Sidney Taurel that "it is simply wrong to suggest that information on Prozac was ever missing or that important research data on the benefits and possible side effects of the drug were not available to doctors and regulators." Lilly complained about "the media reports stating that Prozac is 12 times more likely to cause suicide than other, older antidepressants" as "patently false." The BMJ news article, however, contained no such claim. Taurel's statement seems to be an attempt to declare guilt by association. (Perhaps Taurel was referring to a document posted by CNN that purports to show a suicide attempt rate of 3.7% for fluoxetine vs. 0.8% for amitryptiline, and 0.2% for trazadone.)

More curiously, the press release stated "Lilly is calling on the BMJ to make the full documents available to the media and other interested parties." However, in its accompanying "analysis", Lilly itself declined to make the actual documents public, stating "due to court orders requiring confidentiality of some of the documents contained within the 52 pages, Lilly is unable to relsease the 52 pages of documents." But then did Lilly mean to call on the BMJ to violate a court order? This statement, of course, also contradicts Sidney Taurel's assertion that all relevant information in the documents was freely available to doctors and regulators. How were doctors supposed to access information that was rendered "confidential" by court order?

Thus, there is nothing I can find so far in Lilly's media barrage that refuted the claim made by the BMJ news article that Lilly had tried to prevent data on adverse effects of fluoxetine from affecting doctors' prescribing decisions. And I cannot figure out why a NY Times reporter decided that it was the BMJ, not Lilly, who figuratively earned a "black eye."

Finally, let me state again, we should not let smoke and mirrors distract us from the fundamental issue that suppressing and/or obfuscating information about adverse effects of drugs is bad for patients, bad for doctors, bad for science, and bad for society.

Another story, reported by the Associated Press here and in more detail here, about conflict of interest at the NIH has surfaced. NIH full-time staff are now legally able to collect royalties on inventions they developed while working for the government, including drugs and medical devices. By 2000, The NIH was supposed to develop a process to assure that NIH researchers would disclose such financial interests to patients in clinical studies. The Secretary of the Department of Health and Human Services at the time, Donna Shalala, promised "that any researchers' finanacial interest in a clinical trial be disclosed to potential participants." But the NIH only got around to actually doing so last week, prompted by an enquiry by an Associated Press reporter about royalty payments and the policy for their disclosure under the Freedom of Information Act.

For example, Dr. Anthony Fauci and Dr. H. Clifford Lane, who helped develop Interleukin-2, have each received more than $45,000 since 1997 in royalties. Meanwhile, they continued to have influence over continuing trials of the drug. Independently concerned about the appearance of conflict of interest, they asked for outside reviews of their work. But when Fauci tried to return his royalties, and to disclose them on a standard government form, agency managers told him he could do neither. Furthermore, in the absence of any NIH policy about disclosing the royalties, neither Fauci nor Lane informed study patients about them.

Again, the NIH is one of the most important biomedical research organizations in the world. It used to have a reputation for impeccable integrity. So I will simply repeat what I said in another post : "In my humble opinion, it is a tragedy and disgrace for the country's and perhaps the world's premier biomedical research organization to be tainted by leaders with the gross sorts of conflicts of interest reported in yesterday's articles. It will take drastic measures to cleanse it. But until it is cleansed, can anyone fully trust its actions?"

A study published in the Journal of Clinical Oncology suggests that breast cancer patients who are obese, have less income/education, or live in certain geographic regions are more likely to received a reduced (less than recommended) initial chemotherapy dose. The statistics are somewhat complicated, but here is a general summary of the study.

Griggs JJ, Culakova E, Sorbero ME, van Ryn M, Poniewierski MS, Wolff DA, Crawford J, Dale DC, Lyman GH. Effect of patient socioeconomic status and body mass index on the quality of breast cancer adjuvant chemotherapy. J Clin Oncol. 2007 Jan 20;25(3):277-84. [Abstract]

>700 consecutive patients from multiple sites throughout the United States were included. To be eligible, they had to be >18 years old, have confirmed diagnosis of stages I, II, or III breast cancer, starting a new, standard chemotherapy regimen of at least 4 courses.

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The BBC reports that new studies have shown that healthy brain cells are very vulnerable to chemo drugs.

Drug therapy for cancer can prompt a wide range of neurological side effects, even the onset of dementia.

But they were thought not to be directly linked to the drug treatment itself.

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