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.
MSNBC: FDA had concerns 2 years before alcohol wipe outbreak, didn’t act
Filed under: Government, Health journalism, Hot Health Headline
JoNel Aleccia and the folks at MSNBC.com have dug in deep on news of the FDA’s Jan. 5 recall of tainted alcohol wipes, spurred on by the death of a Texas toddler and complaints from across the country. Aleccia’s findings seem to indicate that, more than a month after the recall, the case of Triad Groups’ trainted products and related failures of FDA oversight may run far deeper than the original notice implied.
Aleccia’s been helped in the follow-up investigation by unofficial access to FDA records, validated by outside sources, that indicate inspectors detected problems in 2009, and again in 2010, but didn’t act until this year’s recall.
Documents show that FDA officials expressed concerns following visits to the Triad plantfrom July 15 to July 17, 2009, and again from April 19 to May 18, 2010. Inspectors reported that the company could not validate the processes used to ensure quality or sterility not only of alcohol prep pads and wipes, but also other products used for intimate care.
…
The inspection documents, known as FDA Form 483s, were obtained by msnbc.com from a confidential source and confirmed by FDAzilla.com, an independent Web site that monitors the FDA. Copies of the documents were sent to the FDA for review; the agency did not deny their authenticity.
For a thorough roundup of all the points at which warnings surfaced, or at which the FDA could have intervened, check out Aleccia’s full report.
Speaking of FDAzilla.com, it might be a site worth checking out if you’re interested in the FDA’s activities. It’s free and says it has “made millions of pages of FDA data (MAUDE, devices, drugs, 483s listing, FDA employees) more usable and searchable.” The FAQ says most of its data is automatically updated nightly from files posted on FDA.gov.
Australian journal says no to pharma ads
Filed under: Conflicts of interest, Health journalism, Hot Health Headline
Emergency Medicine Australasia, an Australia-based medical journal, has declared that it will no longer accept paid advertisements from pharmaceutical companies.
Image by acediscovery via FlickrThe journal’s editors announced their decision in an editorial, and we learned about it from Pharmalot’s Ed Silverman. In the editorial, the editors say they’re drawing a line in the sand and all but dare other publications to join them. Here’s Silverman with the how-and-why:
The ban followed discussions with other emergency medicine specialists, who worried aloud that advertised drugs were supported by evidence that was neither “of reasonable quality, nor independent.” There were cases of “dubious and unethical” research practices by pharma, including ghostwriting. And academics may face pressure to withhold negative research, which could “inflate views of the efficacy” of heavily promoted drugs.
For more, refer to this AAP story. In this case, the acronym refers to the Australian Associated Press, not the physician group. In Australia, medical journals are one of the only places where pharmaceutical advertising is legal.
Reform opponents got millions from industry
Filed under: Conflicts of interest, Health care reform, Health policy, Hot Health Headline, Public records
Caitlin Ginley, of the Center for Public Integrity, used data from the National Institute on Money in State Politics to demonstrate that the state officials who have joined forces to file a lawsuit challenging American health care reform have, together, received more than $5 million in campaign contributions from hospitals, pharmaceutical companies, doctors and insurers. Among the governors and attorneys general in the 20 states supporting the suit, a few stood out.
… the Center found that top recipients of industry money include Texas Attorney General Greg Abbott, who has received more than $1 million from health care professionals since 1996, and former Georgia Governor Sonny Perdue, who took in at least $970,163 from the industry starting in 1992, when he was a state senator, until he left the governor’s office this week. Other major recipients involved in the lawsuit include former Pennsylvania Attorney General and newly-elected Governor Tom Corbett, who has received about $830,000, and Mississippi Governor Haley Barbour, with more than $770,000.
Ginley provides details on the donations each of those officials received, as well as several others. No word on how this compares to other samples of 40 high profile state politicians. Physician groups and private doctors played a major role in many of the cases she examined.
Some fear DSM update opens door for exploitation
On All Things Considered, NPR’s Alix Spiegel looks to the past and future to ferret out the potential drawbacks and benefits of the expanded psychiatric diagnoses proposed in the upcoming revision of the American Psychiatric Association’s Diagnostic and Statistical Manual.
Photo by Richard Masoner via Flickr
Spiegel begins with the forceful perspective of Allen Frances, the man who edited the last update of the DSM. From Frances, Spiegel pulls a few cautionary tales of the unintended consequences of changing DSM entries.
The first? Aspergers.
It’s a disease that needed to be diagnosed, Frances says, but it’s now massively overused because of the unforeseen “unintentional incentive” created by schools that offer greatly expanded educational resources to children diagnosed with Aspergers.
“And so kids who previously might have been considered on the boundary, eccentric, socially shy, but bright and doing well in school would mainstream [into] regular classes,” Frances says. “Now if they get the diagnosis of Asperger’s disorder, [they] get into a special program where they may get $50,000 a year worth of educational services.”
Another cautionary tale? Bipolar disorder. The last DSM revision made it a far easier diagnosis to get. In essence, this easier diagnosis opened a gaping door in medicine, one which pharmaceutical companies quickly muscled through.
“Drug companies got indications for treating bipolar disorder,” Frances says. “Not just with mood stabilizers, but also with the newer antipsychotic drugs. And they began very intensive ubiquitous advertising campaigns. So the rates of bipolar disorder doubled. And lots of people got way too much antipsychotic and mood stabilizing medicines. And these aren’t safe drugs.”
For the other side of the story, Spiegel spoke to a psychiatrist who argued that broadening diagnoses means that fewer of the mentally illl go undiagnosed, and that diagnoses are delivered earlier than they would be otherwise. Furthermore, he believes that adding illnesses to the DSM will spark research and investment toward treating those ilnesses.
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.”
ProPublica finds academic physicians violating schools’ conflict rules
Filed under: Health data, Health journalism, Hospitals, Hot Health Headline, Pharmaceuticals, Public records, Tools
While journalists have been finding innovative ways to use ProPublica’s Dollars for Docs database, the database’s founders, Tracy Weber and AHCJ President Charles Ornstein remain ahead of the curve when it comes to using the freely available data for fresh stories.
This time around, the duo looked for medical schools with strict conflict-of-interest policies and ran their faculty lists through the database. They found dozens of matches, even at elite research institutions. It’s an idea so effective that it’s a wonder nobody thought of it sooner – and apparently the institutions involved feel the same way.
“For God’s sake, if the media can look at these websites, why can’t we?” said David Rothman, president of the Institute on Medicine as a Profession at Columbia University. “Why trust if you can verify?”
Stanford, the University of Pennsylvania, the University of Colorado Denver and the University of Pittsburgh drew particularly heavy attention. (On the other side of the coin, UMass Memorial Health Care was singled out as an example of a robust conflict policy.)
Pizzo, Stanford’s dean, said physicians who appear to have violated the policy will be investigated and referred for discipline if necessary. He compared some of their explanations to what a cop might hear after catching a motorist running a late-night stop sign.
“You can give 1,000 reasons: There was nobody around. It’s safe. I looked and didn’t harm anyone,” he said. “The reality is, it’s still a stop sign.”
Watch the full episode. See more Nightly Business Report.
And this isn’t just a database story. Weber and Ornstein also found time for a review of various academic conflict of interest policies and point out how policies are weakened through inaction, loopholes and a reliance on self-policing.
Public Citizen: Pharma tops government defrauders
Filed under: Health policy, Hot Health Headline, Studies
The nonprofit consumer group Public Citizen has conducted an analysis that indicates that the pharmaceutical industry has passed the defense industry as the biggest defrauders of the American federal government. They looked all the way back to 1991, writing that “the total size, varied nature, and potential impact of these illegal and potentially dangerous activities have not been previously analyzed.” Their findings indicate that, not only is pharma fraud dominant, it’s also skyrocketing. Two of the most salient bullet points:
- Of the 165 settlements comprising $19.8 billion in penalties during this 20-year interval, 73 percent of the settlements (121) and 75 percent of the penalties ($14.8 billion) have occurred in just the past five years (2006-2010).
- Four companies (GlaxoSmithKline, Pfizer, Eli Lilly, and Schering-Plough) accounted for more than half (53 percent or $10.5 billion) of all financial penalties imposed over the past two decades. These leading violators were among the world’s largest pharmaceutical companies.
We learned about the study from Milwaukee Journal Sentinel reporter John Fauber, who also blogged about Public Citizen’s findings.
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
BMJ exposes UK drugmaker’s astroturf attempt
Pharmalot blogger Ed Silverman reports that, had they not been exposed by BMJ, the UK pharmaceutical company Norgine probably would have gotten away with quietly organizing doctors and patient groups to submit a letter to The Times protesting a government plan to require substituting generic drugs for brand-name ones where applicable. Norgine’s name appeared nowhere on the letter, which was written by a PR firm they’d hired. Furthermore, several patient groups which signed the letter also received funding from pharmaceutical companies.
In the end though, Silverman writes, Norgine came away from the incident pretty well, considering the outcry over their stunt.
Norgine may have had the last laugh, however. Apart from being lambasted publicly for being a secretive and manipulative company, the drugmaker issued a celebratory press release earlier this month trumpeting the decision by the government to scrap the proposed automatic generic substitution plan.
Related
For more European health news, see AHCJ’s Covering Europe initiative.
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