Pharmola.com

 

[Pharmola.com April 2, 2009] The latest on The Infinite Mind/Fred Goodwin story, from the Center for Media and Democracy and PRWatch: 

The Infinite Mind Was Not Aware

PR Watch has reported previously on conflict of interest issues surrounding psychiatrist Fred Goodwin, the former host of "The Infinite Mind" public radio series. In his role as host of the show, Goodwin talked up the advantages of antidepressant drugs while failing to disclose that he had received $1.2 million in fees for giving marketing lectures on behalf of pharmaceutical companies. After the funding was revealed publicly, Goodwin attempted to claim that he had informed the show's producer, Bill Lichtenstein, of his financial ties to drugmakers (a claim initially echoed by National Public Radio's "On the Media" show). Now Lichtenstein is claiming vindication, and NPR has issued a retraction and public apology for its claim that Lichtenstein knew. Goodwin has also backed away from saying that he disclosed the payments, claiming instead that he doesn't "see these things as a conflict of interest."

RealAge.com = Real Pharma Marketing

The New York Times has reported that the popular web site RealAge.com, which gives visitors a chance to calculate their "biological age" based on their health condition and practices, uses the information they collect to market products for pharmaceutical companies.  The web site, owned by Hearst Communications, has reportedly generated tens of millions of dollars per year in revenue.  A response to the New York Times article was posted on RealAge.com, defending the site's practices, saying that while RealAge.com does send pharma ads to its members based on their answers to health surveys, the site does not release any of its user information. 

Online Age Quiz Is a Window for Drug Makers

By:  Stephanie Clifford

Americans yearn to be young. So it is little wonder that RealAge, which promises to help shave years off your age, has become one of the most popular tests on the Internet.

According to RealAge, more than 27 million people have taken the test, which asks 150 or so questions about lifestyle and family history to assign a “biological age,” how young or old your habits make you. Then, RealAge makes recommendations on how to get “younger,” like taking multivitamins, eating breakfast and flossing your teeth. Nine million of those people have signed up to become RealAge members.

But while RealAge promotes better living through nonmedical solutions, the site makes its money by selling better living through drugs.

APA Weighs in on Pharmaceutical Conflicts of Interest: 
Highlights Problems But Light on Solutions to Crisis

[Pharmola.com March 30, 2009] The American Psychiatric Association (APA), the professional organization that represents 38,000 psychiatrists in the U.S. and internationally, placed the responsibility for avoiding pharmaceutical company conflicts of interest squarely on the shoulders of its member psychiatrists.  In a commentary published in the APA's prestigious "American Journal of Psychiatry," the APA told its member psychiatrists that "Each of us must acknowledge—in the choices that we make—our own responsibility to limit conflicts of interest in order to preserve the integrity of the field that is so important to us all."  At the same time, the APA defended it acceptance of pharmaceutical advertising for the journal, but noted that there may be fewer pharma ads in the future due to decreased pharmaceutical industry spending for print advertising.   

The article, "Conflict of Interest - An Issue for Every Psychiatrist," noted that "Congressional hearings and articles in the New York Times or Boston Globe are far removed from our own practices," apparently referring to the cases, without naming them, of such leading psychiatrists as Dr.'s Fred Goodwin, Charles Nemeroff and Joseph Biederman.  However, in its commentary, the APA offered no major new initiatives or proposals to address the ongoing crisis of pharmaceutical funding that has been improperly accepted by researchers and leading experts, a situation that has led to numerous major investigations and had an impact on the public's perception of psychiatry. 

The article was published under the names of all 23 editors, editorial board members and contributors of the Journal, a list that includes numerous psychiatry luminaries: Robert Freedman, David A. Lewis, Robert Michels, Daniel S. Pine, Susan K. Schultz, Carol A. Tamminga, Nancy C. Andreasen, Kathleen T. Brady, David A. Brent, Linda Brzustowicz, Cameron S. Carter, Leon Eisenberg, Howard Goldman, Daniel C. Javitt, Ellen Leibenluft, Jeffrey A. Lieberman, Barbara Milrod, Maria A. Oquendo, Jerrold F. Rosenbaum, A. John Rush, Larry J. Siever, Patricia Suppes, Myrna M. Weissman, Michael D. Roy, James H. Scully, Jr., and Joel Yager. (Click here to read commentary as PDF file) 

A.P.A.: "No More Free Lunches (or Symposia)" 

(March 25, 2009) — The American Psychiatric Association Board of Trustees has voted to phase out industry-supported symposia along with industry-supplied meals at its annual meetings.

With this move, the APA remains at the leading edge of a trend throughout medicine to increase transparency and reduce potential financial conflicts of interest. Symposia at major medical meetings that supply doctors with continuing medical education credits are sometimes funded by pharmaceutical companies, a practice that has invited a concern that the sessions may be biased in favor of the sponsoring company’s medications.

“Although we took great care to avoid biased reporting at all our symposia, we came to the conclusion that the only way to totally eliminate the risk is to have the symposia supported by the APA alone,” said Nada L. Stotland, M.D., M.P.H., president of the APA.  Click here for the APA's announcement. 

[March 11, 2009 Pharmola.com] The Associated Press reports that AstraZeneca is claiming that a Kansas woman's diabetes was caused by "slurpies...McDonald's, Burger Kind and [a] lot of chinese food," despite the findings of medical experts that it was brought on by the anti-psychotic medication Seroquel.  This could be the first Seroquel case to go to a jury.  More to come. 

AstraZeneca Denies Findings of Experts in 
Seroquel/Diabetes Lawsuit

MARCH 10, 2009 WILMINGTON, Del. (AP) - Attorneys for drugmaker AstraZeneca are challenging the findings of medical experts who claim the company's anti-psychotic drug Seroquel causes diabetes.

A Delaware judge began three days of hearings Tuesday to determine whether to allow testimony from three doctors in a case brought by a Kansas woman who claims that Seroquel caused her to develop diabetes.

Attorneys for AstraZeneca argued that the reports submitted by the medical experts are scientifically and legally insufficient to justify Nina Scaife's claims.

But attorneys for Scaife contend that their expert witnesses are qualified to testify, and that their opinions are supported by scientific literature.

Pharms Across the Water

[Pharmola.com March 10, 2008] IRENE (Investigative Reporters Network, Europe) is a newly-formed network of journalists working in Denmark, Germany, the Netherlands and Belgium who are investigating the pharmaceutical industry in Europe.  The stories they are covering should sound familiar to anyone following recent news here in the U.S.: the supression of negative information about medications; the cultivation of connections with researchers; and drug advertising.  An English translation of their first stories appears on IRENE's web site; they include investigations of "secret reports about side-effects of medicines, lobbyism in the European Union, including financing of patient-organizations and academic opinion leaders, as well as safety of highly popular medicines for ADHD."

Supreme Court Revives Two Anti-Depressants/Suicide Suits
After Ruling that Relying on FDA Warnings is Not Enough 

[Pharmola.com March 10, 2009] The Supreme Court revived two lawsuits against GlaxoSmithKline and Pfizer that are related to suicides and antidepressants (see below) in the wake of the high court's decision last week involving a musician who lost her arm due to a botched injection of an anti-nausea medication.  

The Supreme Court ruled on March 4, 2009 that the pharmaceutical company Wyeth was liable for damages to a guitarist, Diana Levine, who lost her arm following an improper injection of the anti-nausea drug Phenergan, that was administered for a migraine.   

Levine claimed that Wyeth had failed to provide sufficient warnings about the risk of quickly injecting the drug into a vein, a process called an IV push, and the risk of gangrene if the injection accidentally hits an artery, which is what happened to Levine, resulting in the loss of her arm.  

The high court rejected by a 6-to-3 vote Wyeth's claim that U.S. Food and Drug Administration labeling approvals pre-empt state laws and shield drug companies from liability suits.  Wyeth also said it believed federal law prohibited it from providing stronger warnings than approved by the FDA.    

"The question we must decide is whether the FDA's approvals provide Wyeth with a complete defense to Levine's tort claims. We conclude that they do not," Justice John Paul Stevens wrote in the court's majority opinion.

 

High court revives Paxil, Zoloft suits

March 10, 2009

By Greg Stohr

Bloomberg News

The U.S. Supreme Court yesterday gave life to two lawsuits faulting Pfizer Inc. and a GlaxoSmithKline P.L.C. unit for failing to warn that their antidepressants might cause suicidal tendencies in adults.

The justices told the U.S. Court of Appeals for the Third Circuit in Philadelphia, which had rejected the suits, to reconsider them in light of last week's Supreme Court decision giving patients more ability to sue drugmakers.

The antidepressant suits are being pressed by relatives of a woman who killed herself after taking Glaxo's Paxil and a man who committed suicide after taking Pfizer's Zoloft.

US cites Boston psychiatrist in case vs. drug firm

Complaint alleges kickbacks to MDs

By Liz Kowalczyk

March 6, 2009

Federal prosecutors say that a Massachusetts General Hospital psychiatrist became a "star spokesman" in helping a pharmaceutical company promote its drugs for treating depressed children, even though the medications were not approved for pediatric use by the US Food and Drug Administration.

	Discuss
	COMMENTS (7)

In a complaint unsealed last week in US District Court in Boston, prosecutors allege that New York-based 

Forest Laboratories Inc.  illegally marketed the drugs Celexa and Lexapro for use in children by paying kickbacks, including lavish meals and cash payments disguised as grants and consulting fees, to induce doctors to prescribe the drugs. They also say the company misled doctors and the public by failing to disclose the results of a negative study.

In the 34-page complaint, prosecutors said that from 1999 to 2006, Dr. Jeffrey Bostic, director of school psychiatry at the hospital, gave more than 350 Forest-sponsored talks and presentations in 28 states, many of which addressed pediatric use of Celexa and Lexapro.

"Forest also paid Dr. Bostic to meet other physicians in their offices in order to ease their concerns about prescribing" the drugs, the complaint said. Doctors are allowed to prescribe children drugs not approved by the FDA for pediatric use, a practice called "off label" use.

The government said that Bostic became "Forest's star spokesman in the promotion of Celexa and Lexapro for pediatric use" and that the company paid him more than $750,000 between 2000 and 2006 for his presentations. The complaint quotes an unnamed Forest sales representative as saying, "Dr. Bostic is the man when it comes to child psych."

Feds to doctors: Stop illegal kickbacks or face prosecution

For weeks, I have been struggling with why it is that leading doctors, particularly psychiatrists, have been willing to take large amounts of funds from pharmaceutical companies, and not disclose them.  It has been suggested that it's hubris or entitlement, but neither seemed right. Then I read the following in Gardiner Harris' New York Times story that reports the federal Department of Health and Human Services (HHS) is getting ready to crack down on doctors who accept pharmaceutical funds and don't disclose them (see cases of Dr.'s Joseph Biederman, Charles Nemeroff, and Fred Goodwin, among others.)  

In the article (below) Harris quotes Lewis Morris, chief counsel to the Inspector General of HHS, as saying:

A common problem in illegal drug and device marketing cases is doctors’ willingness to delude themselves into thinking that cash, lucrative trips and other kickbacks do not affect them, said Mr. Morris, the chief counsel.

“Somehow physicians think they’re different from the rest of us,” Mr. Morris said. “But money works on them just like everybody else.”

Mr. Sullivan, the United States attorney, said officials hoped to send a strong message to doctors. “I have been shocked at what appears to be willful blindness by folks in the physician community to the criminal conduct that corrupts the patient-physician relationship,” he said.

I think Messrs. Morrow and Sullivan hit the nail on the head.  Will we see doctors behind bars for taking kickbacks?  

Stay tuned.  

Crackdown on Doctors Who Take Kickbacks

By Gardiner Harris
March 3, 2009

Washington — Federal health officials and prosecutors, frustrated that they have been unable to stop illegal kickbacks to doctors from drug and device companies, are investigating doctors who take money for using these products.

For years, prosecutors rarely pursued doctors because they believed that juries would sympathize with respected clinicians. But within a few months, officials plan to file civil and criminal charges against a number of surgeons who they say demanded profitable consulting agreements from device makers in exchange for using their products.

Twenty-One and Bust

At least 21 pubished medical studies involved the use of falsified data and fraud in what is being called one of the largest cases of academic misconduct to date.

The research was conducted by Massachusetts doctor Scott S. Reuben, MD, according to a March 2009 article in Anesthesiology News. The article also reported that a "cornerstone of Dr. Reuben's approach has been the use of [Celebrex] ... and the neuropathic pain agent [Lyrica], both manufactered by Pfizer.  Dr. Reuben has received research grants from the company and is a member of its speakers’ bureau."  (See list of reserach studies involved at bottom). 

   

Fraud Case Rocks Anesthesiology Community

Mass. Researcher Implicated in Falsification of Data, Other Misdeeds  

In what experts are calling one of the largest known cases of academic misconduct, a leading anesthesiology researcher has been accused of falsifying data and other fraud in potentially dozens of published studies.

Scott S. Reuben, MD, of Baystate Medical Center in Springfield, Mass., a pioneer in the area of multimodal analgesia, is said to have fabricated his results in at least 21, and perhaps many more, articles dating back to 1996. The confirmed articles were published in Anesthesiology, Anesthesia and Analgesia, the Journal of Clinical Anesthesia and other titles, which have retracted the papers or will soon do so, according to people familiar with the scandal (see list). The journals stressed that Dr. Reuben’s co-authors on those papers have not been accused of wrongdoing.

In addition to allegedly falsifying data, Dr. Reuben seems to have committed publishing forgery. Evan Ekman, MD, an orthopedic surgeon in Columbia, S.C., said his name appeared as a co-author on at least two of the retracted papers, despite his having had no hand in the manuscripts. “My names were forgeries on the documents,” Dr. Ekman told Anesthesiology News. 

Dr. Reuben has been an extremely active and visible figure in multimodal analgesia, particularly as an advocate for its use in minimally invasive orthopedic and spine procedures. His research has provided support for several mainstays of current anesthetic practice, such as the use of nonsteroidal anti-inflammatory drugs and neuropathic agents instead of opioids and preemptive analgesia. Dr. Reuben has also published and presented data suggesting that multimodal analgesia can significantly improve long-term outcomes for patients.

Incomprehensible Course

All of that is now in question, said Steven L. Shafer, MD, editor-in-chief of Anesthesia and Analgesia, which retracted 10 of Dr. Reuben’s articles. “We are left with a large hole in our understanding of this field. There are substantial tendrils from this body of work that reach throughout the discipline of postoperative pain management,” Dr. Shafer said. “Those tendrils mean that almost every aspect will need to be carefully thought through. What do we still believe to be true? Do the conclusions hold up to scrutiny?”

Dr. Shafer said that although he still believes “philosophically” in multimodal analgesia, he can no longer be absolutely certain of its benefits without confirmation from future studies.

E-Mail: AstraZeneca Knew in 1997
that Seroquel Caused Weight Gain

By Jim Edwards
March 3, 2009

AstraZeneca knew as far back as 1997 that Seroquel put patients at risk of weight gain, according to the company’s own internal memos. The documents also appear to show that some AZ execs developed strategies to “neutralize” information that suggested Seroquel caused weight gain or diabetes, even after the FDA asked the company to warn patients about Seroquel’s diabetes side effect.

The memos were produced in the ongoing Seroquel litigation. The contents of some of them have been reported on before, but Philip Dawdy at Furious Seasons has created a page on which they can all be downloaded, here.

The documents consist of AZ’s internal emails, draft papers and promo materials. Some of them concentrate on whether the data on Seroquel was showing signs of weight gain or diabetes. And the Clinical Psychology and Psychiatry blog has a lengthy dissection of just one study that seems to show that Seroquel isn’t as good as Haldol.

What follows, however, is a selection of quotes from memos written by AZ’s staff, all on the subject of weight gain, diabetes, and whether the company knew that Seroquel was causing these side effects. The memos form a timeline of who knew what, and when.

Feb 12, 1997, memo from Richard Lawrence:

I am not 100% comfortable with this data being made publically available at the present time … however I understand we have little choice … Lisa has done a great ’smoke-and-mirrors’ job!

Senator Asks Pfizer About Harvard Payments

By Duff Wilson
March 3, 2009

Senator Charles E. Grassley on Tuesday asked the drug maker Pfizerto provide details of its payments to at least 149 faculty members at Harvard Medical School. (See Grassley letter to Pfizer.)  

The senator, an Iowa Republican who is investigating the drug industry’s influence on the practice of medicine, also asked for any Pfizer e-mail, faxes, letters or photos regarding Harvard medical students who have protested drug company influence.

Mr. Grassley, in a letter to Pfizer, wrote that he was “greatly disturbed” to read an article in The New York Times on Tuesday describing a Pfizer representative taking cellphone photographs of the medical students last October at a campus demonstration against industry influence. “I find this troubling as I have documented several instances where pharmaceutical companies have attempted to intimidate academic critics of drugs,” he wrote.

Harvard Medical School in Ethics Quandary
(See related story on Pfizer's surveillance of Harvard student protesters)

By DUFF WILSON

March 2, 2009

BOSTON — In a first-year pharmacology class at Harvard Medical School, Matt Zerden grew wary as the professor promoted the benefits of cholesterol drugs and seemed to belittle a student who asked about side effects.

Mr. Zerden later discovered something by searching on line that he began sharing with his classmates. The professor was not only a full-time member of the Harvard Medical faculty, but a paid consultant to 10 drug companies, including five makers of cholesterol treatments.

“I felt really violated,” Mr. Zerden, now a fourth-year student, recently recalled. “Here we have 160 open minds trying to learn the basics in a protected space, and the information he was giving wasn’t as pure as I think it should be.”

Mr. Zerden’s minor stir four years ago has lately grown into a full-blown movement by more than 200 Harvard Medical School students and sympathetic faculty, intent on exposing and curtailing the industry influence in their classrooms and laboratories, as well as in Harvard’s 17 affiliated teaching hospitals and institutes.

Pfizer Worker Photographed Protesters at Harvard
Duff Wilson
March 2, 2009

Harvard Medical School’s rules say that students on campus are supposed to be off-limits to drug company representatives.

That is why David Tian, a first-year Harvard medical student, said he found it “strange and off-putting” last fall when a man who identified himself as a Pfizer employee took a cellphone photo of students as they demonstrated against pharmaceutical industry influence on campus. “We could only assume he intended to share this with his company,” Mr. Tian said.

The students did not get the man’s name, but they took his picture.

Asked about the mysterious Pfizer man on campus and shown his picture, a company spokesman said he had recently contacted the employee and concluded that he had done nothing wrong. Declining to name him, the spokesman, Ray Kerins, said the employee had photographed the students for personal use.

 

Seroquel Case: Must AstraZeneca Tell All?

February 24, 2009

In more lawsuits, companies are being forced to reveal internal information during the pretrial discovery phase that otherwise would be kept private

By Michael Orey

A showdown is looming in a Florida courtroom over an issue that has long bedeviled business: How much internal information can a company be forced to make public simply because it has become a defendant in a lawsuit?

In federal court in Orlando, drugmaker AstraZeneca (AZN) is battling to keep confidential thousands of pages of correspondence, studies, and other material related to its blockbuster antipsychotic drug Seroquel. On Feb. 13, Bloomberg News, invoking "the public's right of access to judicial documents," asked the court to unseal selected filings. A hearing on the request is scheduled for Feb. 26.

The battle grows out of claims by consumers who allege that AstraZeneca didn't adequately disclose that Seroquel can trigger serious weight gain and diabetes. There is also an unusual allegation of sexual misconduct that AstraZeneca is trying to keep contained by arguing that it is irrelevant and should be kept from a jury. More than 6,000 Seroquel cases have been consolidated in the Florida case.

 

U.S. Probes Emory Doctor's Glaxo Ties

By David Armstrong

Federal officials are investigating Emory University to determine if the school misled the National Institutes of Health about its star psychiatrist's lucrative consulting work for big drug makers, people familiar with the matter said.

The probe by the inspector general for the Health and Human Services agency, which investigates fraud in NIH programs, concerns the work of Charles Nemeroff. From 2003 until last year, Dr. Nemeroff served as primary investigator on an NIH-funded research effort to study five GlaxoSmithKline PLC drugs for use as antidepressants. During that time, Dr. Nemeroff also received hundreds of thousands of dollars from Glaxo.

A person familiar with the federal probe said investigators are examining whether Emory failed to tell the NIH about Dr. Nemeroff's potential conflicts of interest in conducting the research, and whether the university may have misrepresented the kind of work he did for Glaxo.

 

Forest Labs accused of kickbacks, illegal ads

WASHINGTON, Feb 25 (Reuters) - The United States accused Forest Laboratories Inc (FRX.N) of inappropriately marketing the drugs Celexa and Lexapro for children and paying kickbacks like spa visits to pediatricians who prescribed the drugs, the Justice Department said on Wednesday.

Prosecutors said the antidepressant Celexa was no more effective than a placebo when taken by children or teenagers, and, in fact, more patients taking Celexa reported suicidal thoughts or attempted suicide.

The Food and Drug Administration approved Celexa to treat adult depression but refused to approve it for children, and required that Forest put a warning on the labels for Celexa Lexapro. The two are chemically similar.

Frank Murdolo, Forest Laboratory's vice president of investor relations, said that the company was working with the government in an investigation that dates to 2004.

"We've seen the release but that's all we've seen," he said. "We'll look at the complaint, see what's there. We'll see what the next steps are."

Lexapro is Forest's top-selling drug with sales of $585.5 million in the third quarter of fiscal 2009. Celexa lost patent protection and is no longer a major product for the company.

In the complaint, Forest is accused of pushing aside a study showing that Celexa was ineffective for pediatric use and instead urged its sales staff to promote a second, more positive study.

And Then There Were Two:  
Big Pharma's Continuing Intrusion into the Newsroom

The recent New York Times report that Fred Goodwin, host of public radio's The Infinite Mind, had received more than $1.2 million in undisclosed speaking fees from the pharmaceutical company GlaxoSmithKline at the same time he was hosting the award-winning radio program sent shock waves through the journalistic, public broadcasting and medical worlds. 

While over the years it has been known that pharmaceutical companies have intruded on medicine and science through undisclosed payments to doctors and researchers that have created conflicts of interest, Fred Goodwin was the first case of a drug company's undisclosed payments to a working journalist, the host of a nationally broadcast public radio program, no less.  For that reason, the disclosure about Fred Goodwin's speaking fees from GlaxoSmithKiline was a watershed event. 

On the heels of the Goodwin matter, comes former New York State Lieutenant Governor Betsy McCaughey, who wrote a February 9, 2009 commentary for Bloomberg News entitled "Ruin Your Health with the Obama Stimulus Plan."  In her essay, McCaughey attacked President Obama's proposed stimulus plan as being "dangerous to your health,"  and she falsely claimed that the stimulus package would allow the government to "monitor treatments to make sure your doctor is doing what the federal government deems appropriate and cost effective ... to reduce costs and 'guide' your doctor's decisions.”  

This is not the first time that McCaughey has used a news outlet to undermine proposed innovations to the U.S. medical system.  In 1994, McCaughey lead the attack on the Clinton administration's health care plan, with an article in the New Republic entitled "No Exit," which, as the title suggested, claimed the Clinton health proposal would lock people into government-run health care, with no right to seek doctors or treatments of their choice.  McCaughey's assertions were later shown to be blatantly false, but at the time her article helped derail the Clinton health care plan. 

Not surprisingly, in the wake of McCaughey's attack on the Obama stimulus plan's health provisions, Fox News, the Drudge Report and Rush Limbaugh were quick to pick up on McCaughey's report.  Fox News went so far as to report that "new rules buried deep inside the [stimulus] bill" would allow the government to engage in "healthcare rationing," set "limits on research" and establish "new rules guiding decisions your doctor can make about your healthcare."  Fox News called the supposed healthcare provisions in the stimulus bill "Washington's best kept secret."  

As it turns out, none of what McCaughey reported in her Bloomberg News story, nor what was re-reported by other conservative news outlets, is true, as was detailed by Keith Olbermann on MSNBC's "Countdown": 

McCaughey is an adjunct fellow of the Hudson Institute, a conservative think tank that includes among its other fellows former Supreme Court nominee Robert Bork and convicted former White House aide "Scooter" Libby.  As Olbermann pointed out, it is funded, in part, by pharmaceutical companies and biomedical suppliers.  

If humor can be the best medicine, this is comic relief, courtesy of "The Onion" and their newest "anchorwoman," former CNN journalist Bobbie Battista. 

"FDA Approves Depressant Drug for the Annoyingly Cheerful"

 

Harvard will stiffen rules for staff at med school

Conflict of interest will be redefined

By Liz Kowalczyk 

Globe Staff / February 3, 2009

Harvard Medical School plans to strengthen its conflict-of-interest rules for doctors and researchers, amid a US Senate investigation into several faculty members and a new state law that will make public some of the paymentsdoctors receive from pharmaceutical and medical-device companies.

Many top medical schools, including Stanford University, the University of Pennsylvania, the University of California at Los Angeles and at San Francisco, and the University of Massachusetts have adopted stricter policies in the past two years. Last year, the American Medical Student Association graded Harvard with an F on its conflict-of-interest policy because it does not address issues like whether companies can provide gifts and meals for faculty.

Drugmaker wants to seal info— for you

By Kris Hundley, Times Staff Writer 

February 14, 2009

AstraZeneca, maker of the blockbuster anti psychotic Seroquel, is battling to keep information about the drug out of the public's view … for the public's own good.

This month in Orlando, lawyers for the drugmaker will argue that unsealing company documents, including unpublished clinical trial data and letters from the FDA, could harm "a vulnerable patient population."

"This (disclosure) could jeopardize public safety by causing confusion and alarm in patients, who may then discontinue their medication without seeking the guidance of a medical professional,'' lawyers for the drugmaker said in a recent filing in federal court.

Bitter Pill

Created to treat schizophrenia, Zyprexa wound up being used on misbehaving kids. How the pharmaceutical industry turned a flawed and dangerous drug into a $16 billion bonanza

BEN WALLACE-WELLS

January 28, 2009

In June 1992, not long after the place closed down, a Harvard-trained psychologist named Sergio Pirrotta walked out of Danvers State Hospital for the last time. The psychiatric facility, at this late date, was a baggy old thing, rectangled into a field just north of Boston; whole wings were barely occupied, and vandals had already begun to rip out the mantelpieces and furniture. The hospital had been slowly, incrementally shutting down for a decade, and the patients that remained were the hardest cases, mostly schizophrenics and those with disorders too dense and weird to classify. But now, as Pirrotta took a walk around the campus, even those patients were gone: released into the larger world to fend for themselves or bused to hospitals where the staffs had little psychiatric training.

Pirrotta had come to Danvers in the mid-1970s to rehabilitate children whom the courts had declared insane. Back then the place was overpopulated, the halls packed with madmen who would wander around smoking cigarettes, leering and lunging at the kids. In those days, the drugs used to treat mental illness were crude and ugly things. Thorazine was the best, and it made you into a ghouled and lifeless ogre — your face seized up involuntarily, you kept shuffling around, you were an emotional drone. But gradually the medications got a little bit better, the pharmacology more precise. First there was haloperidol, similar to Thorazine but with less-vivid side effects. Then clozapine, which had at first seemed a wonder drug, before it turned out to trigger a potentially fatal immune deficiency in two cases out of a hundred.

Pfizer Takes $2.3 Billion Charge Linked to Bextra Probe

If you’re going to take a $2.3 billion earnings hit over government investigations, you might as well announce it the same day everybody’s more interested in your $68 billion deal.

Amid the hullaballoo over Pfizer’s bid for Wyeth today, Pfizer announced its fourth-quarter earnings, which fell to $266 million from $2.72 billion a year earlier, due primarily to that enormous charge. It stems from an agreement in principle that Pfizer made with the U.S. Attorney in Massachusetts to resolve probes over alleged off-label marketing of now-withdrawn painkiller Bextra, plus “other open investigations,” the company said.

That $2.3 billion charge dwarfs Eli Lilly’s recent record-breaking $1.42 billion settlement with the Justice Department over off-label marketing of antipsychotic Zyprexa.

Senators Grassley and Kohl Announce Bill To Require Disclosure of Physician Gifts from Pharmaceutical and Medical Device Companies

KaiserNetwork.org January 23, 2009

Senators Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.) on Thursday announced a bill (S 301) that would require pharmaceutical and medical device companies to publicly disclose any gifts and payments to physicians valued at $100 or more per calendar year, CQ HealthBeat reports. Under the legislation, the companies would have to report such gifts and payments toHHS once per year. The bill would allow physicians to contest the reports, which HHS staff would review and validate. In addition, the legislation would pre-empt state laws that require disclosure of gifts and payments to physicians. 

Last year, Grassley and Kohl introduced a similar bill (S 2029) that would have required pharmaceutical and medical device companies to report to HHS quarterly any gifts or payments to physicians valued at $25 or more per calendar year. In a statement, Kohl, chair of the Senate Special Committee on Aging, said, "Since we first introduced the bill, there has been a groundswell of support from every corner," adding, "Patients want to know that they can fully trust the relationship they have with their doctor. I am confident this legislation will pass during the 111th Congress." 

Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, in a statement said that the group, which supported the bill introduced last year, has begun to review the new legislation and plans to work with Kohl and Grassley on the issue. The Advanced Medical Technology Association also has begun to review the new bill. In a statement, Stephen Ubl, CEO and president of AdvaMed, said, "We ... believe it is important that any federal disclosure legislation create a uniform national standard to prevent a patchwork approach by all 50 states" (McCarthy, CQ HealthBeat, 1/22).

Who broke the Fred Goodwin/ The Infinite Mind story? 

Writer David Dobbs posted a story on his "Neuron Culture" blog about Philip Dawdy, who runs the pharmaceutical watchdog site, FuriousSeasons.com.

Dobbs' thesis is that Dawdy is a "one man army" when it comes to covering the pharmaceutical industry, but the New York Times steals his reporting and doesn't give him credit.  A story Dobbs cites as an example is the $1.2 million in undisclosed speaking fees that went to The Infinite Mind's former host, Fred Goodwin. However, Dobbs undermines his point about the quality of reporting in the blogosphere by not getting his own facts straight as he tries to argue that bloggers in their pajamas can out-report major news organizations.  See Dobbs' story: ("Zyprexa, Infinite Mind and mainstream vs. pajama press") and Pharmola's response to it, below. Given the ongoing debate about blog journalism vs. mainstream media, this was an interesting object lesson.

-------------------------------------------------------------------------

David:

I read "Zyprexa, Infinite Mind, and mainstream vs. pajama press" with interest.

The premise of the posting is powerful and dramatic; that "pajama press" bloggers like Philip Dawdy, and his blog (furiousseasons.com) are out-reporting news outlets like the New York Times on stories such as the recent one involving "The Infinite Mind" public radio series, and are not getting credit for it.

However, as president of the company that produced The Infinite Mind, and as someone familiar with the news coverage surrounding the undisclosed pharma fees accepted by the show's former host, Fred Goodwin, I must note that there are numerous facts in the posting that praises Dawdy that are stretched or are flat out wrong. At the same time, the blogger who actually did break the story about Fred Goodwin and The Infinite Mind goes without credit.

 

FALLING FROM MT. OLYMPUS FOLLOW UP

By Lawrence Diller, M.D. on January 18, 2009

Joseph Biederman, America's foremost child psychiatrist, and in the midst of a serious conflict of interest scandal, has agreed to temporary limitations in his role as director of Harvard's Massachusetts General Pediatric Psychopharmacology Clinic. Dr. Biederman, pending the outcome of an ongoing inquiry has "agreed to stop participating in several industry-funded trials" and "agreed not to participate in any outside activities that are paid for or sponsored by industry, such as consulting activities or speaking engagements," according to a statement released by the hospital.

Biederman has strongly pushed a biologic pro-psychiatric drug position on children' mental illness. Information garnered by Senator Charles Grassley's investigations and statements by Biederman uncovered in court related actions has revealed both undeclared drug company financial support to Biederman and commitments on his part to further the commercial interests of the drug giant, Johnson and Johnson. These reports threaten to topple Biederman, arguably psychiatry's most powerful voice on children, from his heretofore, untouchable Olympian heights. Meanwhile, Biederman, not surprisingly, has cried foul.

Report: FDA screening of researchers is unreliable

By Ricardo Alonso-Zaldivar

WASHINGTON — Missing information, loopholes and weak oversight hamper government efforts to uncover financial conflicts by researchers who test experimental drugs before companies seek government approval, an internal watchdog finds.

As a result, the Food and Drug Administration's screening system is unreliable, the Health and Human Services inspector general's office says in a report that is being released today.

"We found a number of limitations in FDA's oversight, leaving FDA unable to determine whether (drug companies) submit financial information for all clinical investigators," the report said.

Investigators examined 118 new drug applications that were approved by the FDA in 2007.  Because scientists can be tempted by profits, the government requires disclosure of possible conflicts involving clinical researchers who review medications before drug companies seek FDA approval.

Medtronic Pays Surgeon ‘$20,000 or More’ -- Much, Much More
(Hint: Try $19 million).

January 16, 2009  Posted by Sarah Rubenstein  

Public disclosures about financial ties between doctors and industry can be imprecise — to put it mildly.

Take Thomas Zdeblick, a prominent spine surgeon and researcher at the University of Wisconsin, who told the university in each of the five years he received payments from Medtronic that he’d received $20,000 or more from the company. One year, he reported getting $40,000 or more.

How much more? Over five years Zdeblick received $19 million in payments from Medtronic to help develop and promote products for the spine, the WSJ reports this morning. It’s the latest example to come out of Sen. Charles Grassley’s probe into potential conflicts of interest among doctors funded by industry. 

January 15, 2008

The U.S. Justice Deparment settled with Eli Lilly and Company over the pharmaceutical company's promotion of the drug Zyprexa for uses not approved by the FDA.  The so-called "off-label" markting of a drug for non-FDA approved uses is criminal, and Lilly settled the matter for $1.4 billion, including $515 million, the lagest criminal fine in history, federal prosecutors said on January 15.  

According to prosecutors, Zyprexa was approved by the FDA to treat forms of manic depression and schizophrenia.  However, Lilly marketed the drug to elderly patients as a treatment for dementia, Alzheimer's agitation, depression and generalized sleep disorder.  The company also pressed pediatricians and family practice doctors to treat disruptive children with Zyprexa, court documents show, even though the medicine’s tendency to cause severe weight gain and metabolic disorders is particularly pronounced in children. Over the last decade, Zyprexa’s use in children has soared. 

See January 15, 2008 CBS Evening News report:

Drug Companies & Doctors: A Story of Corruption

Volume 56, Number 1 · January 15, 2009

By Marcia Angell

Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial by Alison Bass, Algonquin Books of Chapel Hill, 260 pp., $24.95

Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs by Melody Petersen, Sarah Crichton/Farrar, Straus and Giroux, 432 pp., $26.00

Shyness: How Normal Behavior Became a Sickness by Christopher Lane, Yale University Press, 263 pp., $27.50; $18.00 (paper)

Recently Senator Charles Grassley, ranking Republican on the Senate Finance Committee, has been looking into financial ties between the pharmaceutical industry and the academic physicians who largely determine the market value of prescription drugs. He hasn't had to look very hard.

Take the case of Dr. Joseph L. Biederman, professor of psychiatry at Harvard Medical School and chief of pediatric psychopharmacology at Harvard's Massachusetts General Hospital. Thanks largely to him, children as young as two years old are now being diagnosed with bipolar disorder and treated with a cocktail of powerful drugs, many of which were not approved by the Food and Drug Administration (FDA) for that purpose and none of which were approved for children below ten years of age.