Ho-hum, Another Month, Another Set of Multi-Million Dollar Settlements by Health Care Corporations Acting Badly
Amazingly, with a US presidential election looming, there is finally some public discussion here of the impunity of top corporate executives. Columnist Gretcher Moregenson wrote on February 6, 2016 in the New York Times,Ho-hum, another week, another multimillion-dollar settlement between regulators and a behemoth bank acting badly.Then,As has become all too common in these cases, not one individual was identified as being responsible for the activities. Once again, shareholders are shouldering the costs of unethical behavior they had nothing to do with.It could not be clearer: Years of tighter rules from legislators ...
Source: Health Care Renewal - February 21, 2016 Category: Health Management Tags: adverse effects deception Fresenius health care prices impunity legal settlements Merck Pfizer Vioxx You heard it here first Source Type: blogs
The 21st Century Cures Act: More Homework To Do
In July, the US House of Representatives approved the 21st Century Cures Act, which heads to the Senate for a vote this fall. While no one can complain about the Act’s purported goal of “bring[ing] our health care innovation infrastructure into the 21st Century,” or increasing funding for the National Institutes of Health, the optimism surrounding the legislation obscures measures buried within that many agree will make newly approved drugs and medical devices less safe and effective, increase the cost of medical products, and discourage innovation in biomedical research.
Long-term value to the public’s health is b...
Source: Health Affairs Blog - September 24, 2015 Category: Health Management Authors: Susan Molchan, James Rickert and John Powers Tags: Costs and Spending Drugs and Medical Technology Featured Health Professionals Hospitals Public Health Quality 21st Century Cures Act Big Pharma Drug approval Fred Upton Research funding Thurgood Marshall Source Type: blogs
Patients and Doctors, not the FDA, Should Choose Right Medicine
Good ideas in Congress rarely have a chance. Rep. Fred Upton (R-Mich.) is sponsoring legislation to speed drug approvals, but his initial plan was largely gutted before he introduced it last month.
Drug discovery is an uncertain process. Companies consider between 5,000 and 10,000 substances for every one that ends up in the pharmacy. Of those, only one-fifth actually makes money—and must pay for everything.
As a result, the average per drug cost exceeds $1 billion, most often thought to be between $1.2 and $1.5 billion. Some estimates run more.
Naturally, the Food and Drug Administration insists that its expensive regul...
Source: Cato-at-liberty - May 27, 2015 Category: American Health Authors: Doug Bandow Source Type: blogs
"Reconnecting the Dots — Reinterpreting Industry–Physician Relations" Provides A Balanced Look At Physician-Industry Collaboration and Conflicts of Interest
Lisa Rosenbaum, MD recently published an article entitled “Reconnecting the Dots—Reinterpreting Industry-Physician Relations,” in The New England Journal of Medicine. Rosenbaum’s article provides a refreshingly balanced analysis of financial conflicts of interest in medicine. “Although most observers agree that we must mitigate the risk of bias introduced by these relationships, the benefits wrought by interactions between physician-scientists and industry at the basic or translational research level are equally clear,” she states. “The question, then, is how to best manage conflicts of interest while preserv...
Source: Policy and Medicine - May 19, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Read it and weep - then get angry!
The Deadly Corruption of Clinical TrialsUpdate (4/3/2015): After nearly 11 years of obfuscation and denial surrounding the tragic death of Dan Markingson, the University of Minnesota has suspended enrollment in psychiatric drug trials. This comes in response to a blistering report issued by the Minnesota State Legislative Auditor that cites "serious ethical issues" and vindicates much of the reporting in the story below. Read more from Carl Elliott about the fallout from the report here.IT'S NOT EASY TO WORK UP a good feeling about the institution that destroyed your life, which may be why Mary Weiss i...
Source: PharmaGossip - April 4, 2015 Category: Pharmaceuticals Authors: insider Source Type: blogs
Read it and weep - then get angry!
The Deadly Corruption of Clinical TrialsUpdate (4/3/2015): After nearly 11 years of obfuscation and denial surrounding the tragic death of Dan Markingson, the University of Minnesota has suspended enrollment in psychiatric drug trials. This comes in response to a blistering report issued by the Minnesota State Legislative Auditor that cites "serious ethical issues" and vindicates much of the reporting in the story below. Read more from Carl Elliott about the fallout from the report here.IT'S NOT EASY TO WORK UP a good feeling about the institution that destroyed your life, which may be why Mary Weiss i...
Source: PharmaGossip - April 3, 2015 Category: Pharmaceuticals Authors: insider Source Type: blogs
Why don’t some parents believe the safety of vaccines?
As a medical student, I strongly support vaccination. It works, it’s safe, and it doesn’t cause autism. But I also understand why many parents don’t believe me and the medical community when we beg them to vaccinate their kids.
Medicine has come a long way from “do no harm.” Now we talk about risks and benefits: and none of our tests, medicines, or procedures are without risks. Increasingly, pharmaceutical companies have been caught concealing those risks from doctors and the public.
Around 2000, Merck (the manufacturer with a monopoly on the MMR vaccine that protects against measles) ...
Source: Kevin, M.D. - Medical Weblog - February 28, 2015 Category: Journals (General) Authors: Vamsi Aribindi Tags: Meds Pediatrics Source Type: blogs
The Bigger They Come, the Softer They Fall - the Size of Pharma Companies and How Vigorously they are Prosecuted
After we found lessons to be learned from even relatively small legal cases involving medical device companies, we reviewed some relatively small cases involving pharmaceutical companies made public in 2014. Again, we had an index case that linked to larger issuesMerck Settled Fraud Allegations for $31 MillionThis case got very little coverage in October, 2014. A very short story by Reuters included these essentials,A subsidiary of Merck & Co has agreed to pay U.S. states $31 million to settle claims that it overcharged their Medicaid programs for an antidepressant it had sold at a discount to pharmac...
Source: Health Care Renewal - November 14, 2014 Category: Health Management Tags: adverse effects deception Eli Lilly fraud impunity kickbacks legal settlements Merck Takeda Teva US Department of Justice Source Type: blogs
Big Data Peeps At Your Medical Records To Find Drug Problems
[NPR] No one likes it when a new drug in people’s medicine cabinets turns out to have problems — just remember the Vioxx debacle a decade ago, when the painkiller was removed from the market over concerns that it increased the risk of heart attack and stroke. To do a better job of spotting unforeseen risks […] (Source: blog.bioethics.net)
Source: blog.bioethics.net - September 2, 2014 Category: Medical Ethics Authors: Jennifer Miller, PhD Tags: Health Care Informed Consent Privacy Public Health Biolaw biotechnology economics electronic health records FDA Genetic Testing and Privacy Issues health care reform hospitals insurance pharmaceutical industry Social Matters Source Type: blogs
The Role Of Black Box Warnings In Safe Prescribing Practices
TweetNote: In addition to Lara Maggs, Aaron Kesselheim also coauthored this post.
In the Health Affairs article, “Era of Faster Drug Approval Has Also Seen Increased Black-Box Warnings and Market Withdrawals,” published in the August issue, Cassie Frank and coauthors compare the number of approved prescription drugs that received black-box warnings or were withdrawn from the market for safety-related reasons prior to the 1992 Prescription Drug User Fee Act (PDUFA) with black-box warnings and safety-related withdrawals in the post-PDUFA era.
PDUFA for the first time authorized FDA to collect user fees from brand-name...
Source: Health Affairs Blog - August 20, 2014 Category: Health Management Authors: Lara Maggs and Aaron Kesselheim Tags: All Categories Bioethics Patient Safety Pharma Policy Public Health Source Type: blogs
Big Pharma pushes the Snake Oil approach
FDA has free-speech, safety issues to weigh in review of ‘off-label’ drug marketing rulesShould a pharmaceutical sales rep be allowed to tell a doctor that Topamax, a drug approved to treat seizures and prevent migraine headaches, might also help combat alcohol dependence? Or suggest the epilepsy drug Neurontin could also help treat bipolar disorders or insomnia? Or offer data showing that any number of other drugs could have uses beyond those listed on their labels?For decades, the answer overwhelmingly has been no. The Justice Department has aggressively pursued companies that run afoul of rules agains...
Source: PharmaGossip - July 10, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
There They Go Again - Merck Threatened Legal Action Against Italian Doctor who Criticized Zetia
It seems that when confronted with unfavorable facts or opinions, Merck executives like to threaten legal action, rather than just argue their side of the case. Last month we discussed how Merck officials used the US court system to try to prevent a physician from publicizing evidence uncovered in prior litigation that suggested Merck employees had concealed the risks of Vioxx from research subjects.Legal Threats to Shut Up a Critic Recently, a British Medical Journal news article explained how Merck tried to shut up an Italian physician who dared criticize another of its drugs, Zetia (ezetimibe).The Italian branch o...
Source: Health Care Renewal - July 8, 2014 Category: Health Management Tags: anechoic effect ezetimibe legal settlements Merck Source Type: blogs
At Merck's Urging, a Federal Judge Threatens to Sanction a Lone Professor for Trying to Reveal Evidence about Vioxx
We have written often, and most recently this week, about the limp posture taken by US law enforcement and regulatory agencies in the face of misbehavior by large health care organizations. At best, official action often results in legal settlements which let companies pay fines, sometimes large, while the individuals who profited most from the alleged wrongdoing do not suffer any negative consequences. Worse, the legal settlements often allow the companies to continue to deny any culpability, and the legal evidence underlying the settlement, which might let the public at least estimate culpability, is often ke...
Source: Health Care Renewal - June 18, 2014 Category: Health Management Tags: anechoic effect confidentiality clause legal settlements Merck Vioxx Source Type: blogs
Deadly Medicines and Organised Crime: a review
This is a web version of a review of Peter Gotzsche’s book. It appeared in the April 2014 Healthwatch Newsletter. Read the whole newsletter. It has lots of good stuff. Their newsletters are here. Healthwatch has been exposing quackery since 1989. Their very first newsletter is still relevant.
Most new drugs and vaccines are developed by the pharmaceutical industry. The industry has produced huge benefits for mankind. But since the Thatcherite era it has come to be dominated by marketing people who appear to lack any conscience. That’s what gave rise to the Alltrials movement. It was founded in January 2...
Source: DC's goodscience - April 16, 2014 Category: Science Authors: David Colquhoun Tags: Academia badscience Big Pharma blogosphere Martin Keller Peter Gotzsche Pharmaceutical Industry Richard Eastell Source Type: blogs
