The California Watch wrote about questionable ties between a cardiologist, Dr. Michael Burnam, and a medical device company, St. Jude Medical, Inc.
The allegations are that Dr. Burnam convinced St. Jude to give his son a $200,000 a year job in exchange for a lot of new business. St. Jude manufactures defibrillators, and one patient is accusing Burnam of arranging for a completely unnecessary defibrillator implant surgery. That surgery almost cost a patient his life, when the implanting surgeon accidentally stabbed the patient’s heart with the implant.
This kind of quid pro quo is intolerable, particularly to the extent that patients have no idea of the relationship between their physicians and medical device manufacturers. Part of the problem in this case is that, as alleged by the patient, the cardiologist deliberately misinformed the implanting surgeon about the patient’s medical history. Had he been properly informed, the surgeon would have realized that the surgery was unnecessary.
This may be an extreme case, but there are countless examples of doctors who receive trips, dinners, sporting event tickets and other “prizes” in exchange for business. Can a doctor really have a patient’s best interests at heart when he receives something of value from one device manufacturer and not another?
Here are this week’s stories:
- Vioxx: See Shearlings Got Plowed for a quick summary of the Australian Vioxx trial. Good news.
- Defibrillator Battery Recall: 5,418 battery packs used in Lifeline AED and ReceiveR external defibrillators are recalled. See the FDA’s notice.
- Scientist-CEOs: Should pharmaceutical companies bring back the scientist-CEO business model?
- Kickbacks and Hip Implants: Read about a former umpire’s quest for justice when a hip implant fails, and he finds out about the moneyed relationship between his surgeon and the medical device manufacturer.
- Benicar: The Drug Injury Watch has a post on the possible dangers of Benicar.
- Motrin’s Phantom Recall: See Brian Nash’s blog for his take on the J&J recall.
Here are this week’s stories:
- Medtronic: Medtronic reported that it paid $15.7 million to U.S. doctors in the first 3 months of 2010. Payments were for consulting fees and royalties. This report comes well in advance of the new law requiring disclosure beginning in 2013. See Medtronic’s searchable database of payments.
- Digitek: A request for a class certification was recently denied in the Digitek MDL. The MassTortDefense Blog has an update.
- PediaCare Recall: over 100,000 bottles of PediaCare, formerly manufactured by Johnson & Johnson (and, still being manufactured in their facility), have been recalled. This is a precautionary recall, based on the known problems with the J&J manufacturing facility.
- AstraZeneca and Social Media: Here is AstraZeneca’s take on the transparency/social media issue.
- Generic Drugs: The Supreme Court asks Obama’s administration for an opinion as to whether generic drug manufacturers can be sued for inadequate labeling that matches labeling of brand-name drugs. Here is the Eighth Circuit’s opinion, deciding that generic drug manufacturers can be held liable.
- Celebrities in the News: Dennis Quaid is bringing public awareness to injuries caused by pharmaceutical companies. He settled with the hospital on the heparin overdose of his children, but now he’s going after the pharmaceutical company, Baxter Healthcare Corp.
- More on Whistleblowing: Wyeth (through Pfizer) is accused of illegally promoting its kidney transplant drug for other organs and specifically among African-Americans, who have greater risks associated wit the drug.
The medical journal The Lancet is chiming in on the Avandia debacle. Back in 2009, The Lancet published a paper about the RECORD study (funded by Avandia manufacturer GlaxoSmithKline) which was widely criticized. The major complaint is that the article did not include the drop-out rate—without knowing which patients went off the drug, it is impossible to calculate the risk of Avandia-caused heart attacks.
Now, The Lancet issued an editorial titled “Strengthening the credibility of clinical research.” It describes briefly the Avandia situation, likening the recent Senate Committee on Finance report to a John Grisham novel: “GlaxoSmithKline (GSK), intimidated researchers and manipulated the scientific process for commercial advantage.”
Here are some “talking points” from the editorial:
- at a time when some pharmaceutical firms have received record fines for misconduct, the saga of rosiglitazone [Avandia] tests the limits of tolerance
- such findings damage all who are involved in clinical research, and will likely make funding, ethical approval, and recruitment more onerous for future studies
- trust between doctor and patient, researcher and participant, or author and editor is undermined when the foundations on which evidence is built are treated with such casual contempt
- nothing can completely protect against scientific misconduct
The Lancet reported that it has strived to encourage and use better and more transparent protocols, but that a recent audit of those protocols found that “adherence to protocols was ambiguous and selective.” Like a Tiger Woods apology (or a Jesse James apology, or a Michael Richardson apology, insert your celebrity here), they have vowed to do better, and have spent the past three years working with others on Standard Protocol Items for Randomized Trials (SPIRIT). Heck, just having an acronym makes me feel better.
But seriously—The Lancet is a good publication, and its heart is in the right place, I think. Hopefully they can turn this around and restore confidence in scientific studies and pharmaceuticals.
Here are the stories we’re following this week:
- Pfizer: CNN reports on why Pharmaceia, Pfizer’s shell company, “took the fall” for Pfizer’s illegal marketing practices
- Crestor: will the marketing campaign persuade people to take it when they don’t need it? (HT: Patient Safety Blog).
- Seroquel: Two more summary judgment decisions in Delaware (HT: Drug & Device Law Blog).
- Fosamax trials: Scherlings Got Plowed has an update.
- Children and Medical Devices: The FDA is requiring medical device manufacturers to provide additional information on the effects of their devices on children.
- Pfizer Discloses Payments: Pfizer disclosed $35 million in payments to healthcare professionals in the last half of 2009. The payments were for development and marketing. (HT: FiercePharma).
The Avandia debacle heats up, this time in the medical journal community. The editor of the premier medical journal, The Journal of the American Medical Association (JAMA) has taken other journals to task for their methods of publishing articles. Using the Avandia RECORD study as the example of the conflicts of interest rampant in the medical publishing community, the editor explains “concerns about preserving market share apparently trumped concerns about the potential for causing patient harm.” For the past ten years, JAMA has required:
…at least 1 author must indicate that she or he “had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Additionally, that author cannot be funded by any commercial funding source. The source for this criterion is simply the age-old Hippocratic Oath—that physicians, above all else, must do no harm. The JAMA editor clearly understands that when industry pressures are brought to bear, physicians may be (and have been) influenced to in a manner inconsistent with good science. And the result is that people rely on bad studies, and patients take bad drugs with incomplete and faulty information. The editor further recommends that drug study data be freely available to academic researchers.
Not only will the editor’s suggestions (if enacted by other journals) provide a means to double-check data to ensure its quality, but it will provide an extra reason for scientists and researchers to do the right thing from the beginning, and to stay true to the scientific method.
Drug and medical device companies claim that the data from their studies are “proprietary property” and need not be shared. However, that clearly indicates a lack of concern for safety—data should be widely and freely available, because it is the right thing to do for patient safety.
So let’s get with the program, drug companies. Can you stand up in front of your consumers, tell them that you are making all data for your research fully available to anyone who wants to test it, and boldly stand up for patient safety? Please surprise me…
Drug Recall Lawyer Blog Round-Up (03-22-10)
Here are this week’s stories:
- Avandia: The MayoClinic investigated who authored articles supporting Avandia in medical journals, and discovered that 90% had ties to the manufacturer, GlaxoSmithKline (HT: FiercePharma).
- Seroquel: Trial number one is won by AstraZeneca (see blogs here).
- Zocor: FDA issues a new warning for Merck’s cholesterol drug Zocor (HT: Tom Lamb’s Drug Injury Watch).
- Sanofi-Aventis: More on their lessons from the botched Facebook experiment (HT: Pharma Marketing Blog).
Here are this week’s stories:
- 2009 Adverse Event Reports: Avandia (GlaxoSmithKline) and Seroquel (AstraZeneca) topped the charts for most adverse events for the third quarter of 2009, with 1,218 reports and 977 reports, respectively. See The Institute for Safe Medicine Practices (HT: FiercePharma).
- Avandia: “Glaxo Strikes Back at Drug Critics, But It’s a Big Swing and a Miss.” ‘Nuff said.
- $13 Million Zyprexa Settlement: Lilly settled a suit brought by the state of Montana over off-label marketing of Zyprexa, used to treat bi-polar disorder and schizophrenia. Most of the funds will be used to pay for mental health services in the state. See BusinessWeek.
- BPA: Maryland is considering legislation to ban or limit the use of BPA in plastics used by children. See the Baltimore Sun.
- Seroquel Trial: The Seroquel trial (New Jersey), alleging the drug causes diabetes, is in full force. The parties are arguing over whether marketing took precedence over safety research. See Bloomberg.
Here are the stories we’re following:
- Levaquin: NJ.com reports that Levaquin manufacturer Johnson & Johnson may have paid millions in kickbacks to a large pharmacy for prescriptions to nursing home patients. The complaint was filed by the U.S. Attorney in Boston.
- Acetaminophen: An article published in the medical journal Thorax ScienceDaily reports that there may be a direct link between use of acetaminophen during pregnancy and child asthma.
- Twombly/Iqbal Statistics: The Federal Judicial Center has collected preliminary data on motions to dismiss before and after Twombly and Iqbal (hat tip: The Civil Procedure and Federal Courts Blog).
- Prempro: Bloomberg discusses Judge Ackerman’s reduction of the Connie Barton punitive damages verdict (by 93%, from $75 million to $5.6 million) and added $1.2 million in interest to the jury’s compensatory damages verdict of $3.7 million.
The FDA’s Center for Devices and Radiological Health (CDRH—you can follow them on Twitter) will hold a free public meeting to address concerns and discuss strengthening of the 510(k) process. The agenda includes:
- Issues related to predicate devices;
- Issues related to new technologies and scientific evidence;
- Issues related to practices CDRH has adopted in response to the high volume of 510(k) submissions; and
- Issues related to postmarket surveillance and new information about marketed devices.
The FDA receives over 3,000 510(k) submissions every year. “A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.” After much backlash last year about FDA scientist/employee complaints about corruption, safety problems, conflicts of interest and budgeting, the Institute of Medicine (IOM) was called on to comprehensively study (to the tune of $1.3 million) the 510(k) process. That study is expected to be completed in March 2011, but this meeting is a companion to that study.
- Time/Location: 8:00 a.m. to 5:30 p.m.; Hilton Washington DC North/Gaithersburg; 620 Perry Parkway; Gaithersburg, Maryland 20877
- Live webcast
This meeting is another good step the administration has taken to put patient safety first, and to rigorously watch over the medical device regulatory process.