Skyrocketing drug price is chance to examine manufacturing, FDA approval process
St. Louis Post-Dispatch reporter (and Midwest Health Journalism Program Fellow) Jim Doyle has put together a series of stories on KV Pharmaceuticals that read like a primer on the confounding economics of drug manufacture and FDA approval. In the stories, especially the first and last installments, Doyle presents the big picture and helps readers understand why the systems work they way they do.
The first story shows how FDA approval could end up sending the price of a prenatal drug skyrocketing 16-fold and earn piles of money for a local pharmaceutical company. The second involves a U.S. District judge condemning a former head of that same company for “greed, abuse of power, recklessness.” Finally, he ends his tour of pharmaceutical avarice with a stern warning about the potential longterm costs, both monetary and medical, that could result from the fast-track approval of the drug whose approval formed the basis of the first story. For lots more about KV Pharmaceuticals, be sure to check the “Related Reading” box on this page.
Further reading
If you’re looking for more on KV Pharmaceuticals and the Orphan Drug Act, check out Ed Silverman’s post on Pharmalot. There, he interviews a nonprofit advocate who helps explain how KV’s manipulations were possible, how it could happen again and how the act should be modified.
Taking stock of big pharma in Canada
Filed under: Hot Health Headline, Pharmaceuticals
CBC and Radio-Canada have cooperated to produce a comprehensive look at the nation’s pharmaceutical industry, which centers on Montreal, Canada’s second largest city.
Pharma’s Canadian outposts have sputtered in recent months, and Quebec’s government has struggled to keep the companies in-country.
Part 1: Government incentives to pharmaceutical companies.
Part 2: Regulation of clinical trials.
Part 3: Pharma’s role in continuing medical education.
In addition to the stories, be sure to take a look at the top few comments below the story. Also, the “Quick Fact” box, which taught me that “Montreal has the largest number of clinical trial organizations of any city in North America.”
Barlett & Steele uncover chaos, peril of global drug industry
Filed under: Conflicts of interest, Europe, Government, Health data, Health policy, Hot Health Headline, Pharmaceuticals, Public health
In Vanity Fair, Donald Barlett and James Steele have devoted more than 6,000 words to chronicling the gaping holes in the global pharmaceutical industry, particularly as pertains to the globalization of clinical trials. Even if you’re familiar with many of the specific incidents covered, their cumulative effect, driven home with forceful and authoritative prose, is brutal. Each paragraph holds another tale of trials gone wrong, children killed and bad results that somehow never came to the attention of American regulators.
Photo by amyvdh via FlickrIt used to be that clinical trials were done mostly by academic researchers in universities and teaching hospitals, a system that, however imperfect, generally entailed certain minimum standards. The free market has changed all that. Today it is mainly independent contractors who recruit potential patients both in the U.S. and—increasingly—overseas.
They devise the rules for the clinical trials, conduct the trials themselves, prepare reports on the results, ghostwrite technical articles for medical journals, and create promotional campaigns. The people doing the work on the front lines are not independent scientists. They are wage-earning technicians who are paid to gather a certain number of human beings; sometimes sequester and feed them; administer certain chemical inputs; and collect samples of urine and blood at regular intervals. The work looks like agribusiness, not research.
After neatly setting up each pin with demonstrations of how international the pharmaceutical industry has become, then proceed to knock them all down with examples of industry impunity and FDA weakness.
The F.D.A., the federal agency charged with oversight of the food and drugs that Americans consume, is rife with conflicts of interest. Doctors who insist the drug you take is perfectly safe may be collecting hundreds of thousands of dollars from the company selling the drug. … Quite often, the F.D.A. never bothers to check for interlocking financial interests. In one study, the agency failed to document the financial interests of applicants in 31 percent of applications for new-drug approval. Even when the agency or the company knew of a potential conflict of interest, neither acted to guard against bias in the test results.
Related
WikiLeaks cables: Pfizer used dirty tricks to avoid clinical trial payout in Nigeria
Ethics professor takes on clinical trials, marketing
Filed under: Hot Health Headline, Pharmaceuticals
Writing for Mother Jones, University of Minnesota medical ethics professor Carl Elliott digs into the Dan Markingson story first covered by St. Paul Pioneer Press reporters Jeremy Olson and Paul Tosto. Elliott works at the same institution as the physicians who who administered a Seroquel trial that the 26-year-old was enrolled in when he committed suicide.
Given his teaching field and institution, it’s not surprising that Elliot couldn’t stay away from the Markingson story.
…the more I examined the medical and court records, the more I became convinced that the problem was worse than the Pioneer Press had reported. The danger lies not just in the particular circumstances that led to Dan’s death, but in a system of clinical research that has been thoroughly co-opted by market forces, so that many studies have become little more than covert instruments for promoting drugs. The study in which Dan died starkly illustrates the hazards of market-driven research and the inadequacy of our current oversight system to detect them.
Elliot goes after the idea that the new wave of anti-psychotics was any safer than its predecessors, then explains the clinical trial manipulations he says were used to claim they were.
From there, Elliot takes on the use of clinical trials for marketing purposes. Clinical trials can be dangerous, which is theoretically acceptable if they have the potential to advance medical care. But what if patients are just being exposed to those dangers in an effort to sell more drugs?
Gays excluded from clinical trials
Thanks to an awards announcement from the National Lesbian & Gay Journalists Association, we just noticed Jen Colletta’s story in the Philadelphia Gay News about the exclusion of gays from clinical trials. Colletta won an Excellence in News Writing Award. The exclusion of gays in clinical trials is an issue that hasn’t received much mainstream attention, apart from a letter from Colletta’s sources in NEJM, a write-up by Ed Silverman and a story in The Philadelphia Inquirer.
According to Colletta, the data behind the story grew out of a chance discovery by researchers at the Fox Chase Cancer Center in Philadelphia.
“We review all the different trials that are proposed here, and they don’t necessarily open here, but a lot of them are multi-center trials so we do look at them. And I saw that we had been looking at a number of clinical trials that explicitly excluded gay people, and they didn’t necessarily open at Fox Chase, but I started to become more attuned to this and realized that this is a bigger, national issue,” (Brian Egleston, assistant research professor of biostatistics at the center) said.
The researchers analyzed trials listed in the ClinicalTrials.gov database, maintained by the National Institutes of Health and the Food and Drug Administration.
In particular, Colletta reported, homosexuals are excluded from studies about couples, especially those dealing with erectile dysfunction, which are often related to treatments for prostate cancer. It’s entirely normal for a drug trial to have exclusion criteria, but an oversight in NIH regulations mean that the exclusion of homosexuals, unlike exclusion along racial lines, can be implemented arbitrarily.
In the mid-1990s, Congress mandated that NIH establish a set of guidelines that would prevent it from excluding minorities, such as women and African Americans, from federally funded clinical trials unless there was a significant reason. There are currently no such rules regulating the inclusion of LGBT individuals.
The distribution of exclusionary studies is particularly interesting. To put it in perspective, here’s a quick visualization of the data put forth in the NEJM letter:
Journalist recounts the pressure of GSK clinical trial
Filed under: Health journalism, Hot Health Headline
In the wake of questions about GlaxoSmithKline’s Avandia clinic trials, the Austin American-Statesman’s Ana Cantú talks about her own experience in a different GSK clinical trial five years ago. Her column isn’t long, but she manages to capture the pharmaceutical giant’s desperation and the pressure put on participants. It helps that Cantú was, in some ways, a fulcrum for the study’s success.
I don’t want to spoil the story, but it all revolves around the requirement that seven of the 20 participants complete the study to garner sufficient data for submission to the FDA. After 13 participants dropped by the wayside, a sick and unhappy Cantú found herself on the bubble. She needed a medical authorization to drop out and still receive the $4,800 she was due for her participation, but the physicians in charge of the study were under immense pressure to keep her around and maintain that all-important quorum.
In the end, there’s a reason she refers to it as the “most miserable month of my life,” but at the time Cantú had only scratched the surface of the significance of her participation. Now, her reflections are revealing.
Foreign trial data used in 4/5 of approved drugs
Filed under: Health data, Health policy, Hot Health Headline, Pharmaceuticals
FairWarning’s Lea Yu and The New York Times‘ Gardiner Harris drew our attention to a report from the HHS Office of Inspector General which reviewed 2008 data and found that “Eighty percent of approved marketing applications for drugs and biologics contained data from foreign clinical trials.” Furthermore, the OIG found, “Over half of clinical trial subjects and sites were located outside the United States.”
The OIG expects the trend to grow in the future, writing that “Western Europe accounted for most foreign clinical trial subjects and sites; however, Central and South America had the highest average number of subjects per site.”
The FDA only inspected a minuscule percentage of these foreign test sites, but says it has taken the OIG’s advice and is stepping up efforts to put together agreements with its foreign counterparts and to figure out other methods to standardize and evaluate these foreign trials.
Study authors don’t always have access to raw data
Filed under: Conflicts of interest, Hot Health Headline, Pharmaceuticals, Studies
John Fauber of the Milwaukee Journal Sentinel reports on outside authors of drug company-funded studies who do not have access to the raw data behind the study.
In the latest installment of Side Effects, a series examining doctors, drug companies and conflicts of interest, Fauber reports that a researcher who co-authored a study of Multaq that led to the drug’s FDA approval “vouched for the accuracy and completeness of the study despite not seeing the raw data.”
The researcher, Richard Page, chairman of the department of medicine at the University of Wisconsin School of Medicine and Public Health, says he trusts the Sanofi-Aventis, the drug’s manufacturer.
Fauber delves into the differing editorial policies of the Journal of the American Medical Association and the New England Journal of Medicine when it comes to studies in which drug company employees perform the data analysis.
In the case of the Multaq trial, published by the New England Journal of Medicine, the FDA got unanalyzed raw data and did its own analysis. Fauber reports that “one FDA panel member questioned differences between the information included in the published February 2009 study and what was submitted to the FDA.”
Related
- Uncovering conflicts of interest in medicine, research
- Health Journalism 2010: Journalists encounter obstacles in identifying conflicts of interest in medical research
BMJ wants raw data for all drug trials to be shared
Filed under: Hot Health Headline, Pharmaceuticals, Public records
Under the headline “We want raw data, now,” BMJ editor Fiona Godlee recounts the story of how BMJ had to pressure a drug company into releasing full study reports verifying their claims as to the effectiveness of oseltamivir (Tamiflu).
Godlee says that researchers updating their Cochrane review of the drug “failed to verify claims, based on an analysis of 10 drug company trials, that oseltamivir reduced the risk of complications in healthy adults with influenza. These claims have formed a key part of decisions to stockpile the drug and make it widely available.”
Only after Roche was questioned by the BMJ and Channel 4 News did the manufacturer commit to making “full study reports” available. Godlee says that some questions remain, including how patients were recruited and why some neuropsychiatric adverse events were not reported.
Godlee argues that “it can’t be right that the public should have to rely on detective work by academics and journalists to patch together the evidence for such a widely prescribed drug,” saying that “Individual patient data from all trials of drugs should be readily available for scientific scrutiny.”
How the pharma research ’sausage’ is made
Filed under: Health journalism, Hot Health Headline, Public records, Studies
Reporting on Health’s William Heisel has posted the latest installment in his series highlighting the spiciest entries in the Drug Industry Document Archive, this time focusing on the cold mechanics of the drug industry’s research paper assembly line, and its intimate relationship with pharmaceutical marketing.
Again, Heisel focuses on the deposition of Wyeth ghostwriter Karen Mittleman and related documents and memorandums. He lists the names of some key ghostwriters to look out for, then details a number of specific cases when production and marketing concerns clearly outweighed science, at least as far as the pharmaceutical manufacturers were concerned.
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