Crook Alert!! Drug and Medical Device Companies Are Bribing Our Doctors and Exerting Undue Influence on Research
What are these doctors hiding from us?
Can Your Hip Replacement Kill You? Jeanne Lenzer op-ed in The NY Times 1-14-18
When Stephen Tower’s right hip gave out in 2006, he asked his surgeon to implant an artificial one — specifically, a metal-on-metal hip called the ASR XL, made by Johnson & Johnson. He knew what he was talking about: As an orthopedic surgeon, Dr. Tower specializes in complex hip replacements. But what he knew wasn’t enough to protect him from a defect in the device.
Five years after his surgery, and in excruciating pain, Dr. Tower underwent more surgery, this time to have the device replaced. When the surgeon sliced into his hip, what he saw looked like a crankcase full of dirty oil. Tissue surrounding the hip was black. Cobalt leaking from the ASR hip had caused a condition called metallosis, destroying not only local muscle, tendons and ligaments, but harming Dr. Tower’s heart and brain as well.
Despite Dr. Tower’s repeated efforts to warn his colleagues and the company that the implants were harming patients, Johnson & Johnson continued to market metal-on-metal hips. While it withdrew the ASR XL model from the market in 2010, citing slow sales, it continued to sell another, similarly problematic model, the Pinnacle, until 2013.
More than 9,000 patients filed suit against the company, and on Nov. 16, six New York patients won a $247 million trial verdict for serious harms caused by the Pinnacle hip implants and for failing to warn doctors and patients about its dangers. These suits and others are pulling back the curtain on what some doctors call the Wild West of medicine: the untested and largely unregulated medical device industry.
About 32 million Americans — or about one in 10 — have at least one medical device implanted, from artificial joints to cardiac stents, surgical mesh, pacemakers, defibrillators, nerve stimulators, replacement lenses in eyes, heart valves and birth control devices.
These devices have helped countless people, and some have saved lives. But many others are harmed — and doctors and patients are at the mercy of manufacturers’ claims about the safety and efficacy of the devices. Medical interventions are now the third-leading cause of death in the United States, and devices play an increasing role in that statistic.
Many people assume that the Food and Drug Administration requires rigorous testing of medical devices before they are approved, the same as the lengthy approval process it requires for new drugs. In fact, most high-risk devices on the market, including implants, have undergone no clinical testing at all.
Although the standard for approval of a new drug usually calls for two randomized, controlled clinical trials, the standard for many medical devices is no standard at all. Since medical devices didn’t come under regulatory control by the F.D.A. until 1976, the agency simply grandfathered in all devices that were already on the market under a provision known as 510(k), which allows manufacturers to sell most new devices without requiring any clinical testing as long as the manufacturer says its product is “substantially equivalent” to an existing device.
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In addition to the 510(k) pathway, medical device companies can avoid clinical testing for the highest risk devices through the supplement pathway by telling the F.D.A. they made a minor change to a previously approved device. The use of these loopholes is widespread: A study published in The Journal of the American Medical Association in 2009 found that only 5 percent of high-risk implanted cardiac devices even partly met the standard for drug testing.
Metal hips are far from the only devices with catastrophic consequences. In October 2007, Medtronic, a leading medical device manufacturer, recalled the lead wires in its Sprint Fidelis defibrillator after they were found to fracture and misfire, harming or even killing patients. The devices had not been clinically tested and were approved for sale by the F.D.A. through the supplement pathway. But in this case, the “minor change” was a fatal one; the new wire was thinner and prone to fracture.
By the time of the recall, 268,000 leads had been implanted in patients worldwide, the majority in the United States. After the recall, many patients rushed to have the devices removed, but removal posed its own dangers, causing major complications in 15 percent of patients.
Even when devices are subjected to trials, the F.D.A. sometimes ignores danger signs detected by those studies. In 1997, during the approval process of the vagus nerve stimulator, a device made by Cyberonics to treat epilepsy, an F.D.A. adviser voiced concerns about a high death rate noted in patients with the device. But the agency didn’t stop the device from going to market. Instead, it awarded conditional approval, meaning that Cyberonics would have to conduct safety studies after the device was on the market.
The agency didn’t even require Cyberonics to inform patients that there was concern about the death rate, or that they were effectively being made unwitting guinea pigs. When Cyberonics finally submitted five studies that it said proved the device was safe, it failed to include death data for any of the studies, a move the F.D.A. defended, saying the agency hadn’t asked the company to count deaths, only to “characterize” deaths.
How it’s possible to characterize deaths without including any actual data on deaths is anyone’s guess.
With such shockingly lax regulations, it’s no surprise that device recalls have risen over the years; in 2003, there were eight Class 1 device recalls, which the F.D.A. defines as indicating “a reasonable probability” that a device will “cause serious adverse health consequences or death.” In 2016, that number rose to 117, affecting hundreds of thousands of patients.
Loose oversight of devices poses a threat to public health. Yet the Trump administration’s picks to lead the Department of Health and Human Services and the F.D.A. are advocates of deregulation, which they insist will speed the march of “lifesaving” devices to market. This presumes that such speed and innovation is actually lifesaving or life-enhancing. The number of device-related deaths shows how dangerous that presumption is.
The fact that the F.D.A. has allowed lax practices like the 510(k) loophole to continue, despite calls for reform by institutions like the National Academy of Medicine, poses the question of why the F.D.A. would put profits ahead of safety. One clue rests in history: In 1988, President Ronald Reagan changed the position of F.D.A. commissioner from civil servant to political appointee, which has meant that presidents, with their war chests fattened by the drug and device industries, have repeatedly appointed industry-friendly commissioners, with rare exception.
Returning to a system in which F.D.A. commissioners are civil servants is perhaps a first step, but it needs to be the first of many. As a government agency, the F.D.A. is supposed to serve as a bulwark between corporate profiteering and the public welfare. Its continued allowance of regulation loopholes like 510(k), despite the significant demonstrated cost to public welfare, calls into serious question the agency’s fulfillment of its stated mission to protect public health by ensuring safety, efficacy and security.
Jeanne Lenzer is the author of “The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It.”
12-17-13NYTimes--GlaxoSmithKline to Stop Paying Doctors to Promote its Drugs
- Glaxo Says It Will Stop Paying Doctors to Promote Drugs - NYTimes.com
The announcement, an apparent first for a major drug company, would end a common practice that is criticized for posing a conflict of interest.
10-17-13NYTimes "The Myth of the Medical Device Tax"
- The Myth of the Medical-Device Tax - NYTimes.com
What's actually raising health care costs is a predatory industry.
ProPublica Website--Check Here to See if Your Doctor is Being Paid by Pharmaceutical Companies
- Dollars for Docs - ProPublica
ProPublica has compiled the disclosed payments from pharma companies to doctors and other health care providers. Search for your doctor in our interactive database.
10-13-13NYTimes "The Soaring Cost of a Simple Breath" (How Drug Companies are Screwing America)
- The Soaring Cost of a Simple Breath - NYTimes.com
The high price of commonly used medications for conditions like asthma contributes heavily to health care costs and certainly causes more widespread anguish.
9-3-13NYTimes OP-ED "How a Cabal Keeps Generics Scarce"
- How a Cabal Keeps Generics Scarce - NYTimes.com
The root cause: the purchasing organizations have squeezed manufacturers’ operating margins to razor-thin levels. By awarding select suppliers exclusive contracts in return for exorbitant (and undisclosed) “administrative,” marketing and other fees..
7-22-13Glaxo Says its Executives May Have Broken Chinese Law
- Glaxo Says Executives May Have Broken Chinese Law - NYTimes.com
The statement comes amid signs that other drug makers including Merck and Roche could also come under scrutiny from the authorities in China.
7-11-13WallStreetJournal China Accuses GlaxoSmithKline of Bribing Doctors to Prescribe its Drugs
- Chinese Officials Find Evidence GlaxoSmithKline Workers Bribed Doctors, Hospitals - WSJ.com
Chinese officials said they have found evidence that U.K. drug maker GlaxoSmithKline PLC's sales personnel in China rewarded doctors, hospitals, government officials and foundations with cash and perks for prescribing medications.
6-29-13NYTimes--"Breaking the Seal on Drug Research"
- Breaking the Seal on Drug Research - NYTimes.com
More researchers are insisting on seeing all the data behind all clinical trials for drugs, not just the rosy reports that companies choose to release.
Forest Labs Reports Payments to Physicians Under Sunshine Act
- Physician Payment Sunshine: Forest Labs Reports Payments to Physicians | CME Coalition
Payments by the company included those for consulting fees, speaking fees, travel expenses, educational items, meals, and independent physician research funding.
9-15-10WallStreetJournal--Forest Labs to Pay $313 Million Fine
- Forest Labs to Pay $313 Million Penalty - WSJ.com
Forest Labs agreed to pay $313 million to settle criminal and civil charges that it improperly marketed antidepressants and distributed an unapproved thyroid drug.
5-30-13 Alternet "Meet the Doctor Big Pharma Can't Shut Up"
- | Alternet
The pharmaceutical industry has compromised the Western medical establishment and hooked America on drugs. One psychiatrist is fighting back.
4-28-13NYTimes EDITORIAL "Another Alleged Drug Kickback Scheme"
- Another Alleged Drug Kickback Scheme - NYTimes.com
Federal lawsuits paint Novartis as a serial offender that violated laws and its own policies.
2-19-12NYTimes EDITORIAL "Finding Out Who Pays Your Doctor"
- Finding Out Who Pays Your Doctor - NYTimes.com
A new rule issued by the administration will let the public in on payments that influence treatment. The goal is to let the public know about payments that lead doctors to prescribe treatments that benefit them financially without benefit to patients
2-2-13NYTimesOP-ED--"Health Care's Trick Coin"
- Health Care’s Trick Coin - NYTimes.com
If I toss a coin, but hide the result every time it comes up tails, it looks as if I always throw heads. Johnson & Johnson and Roche refuse to release results of device and drug trials.
GlaxoSmithKline's Avandia Coverup
MotherJones "Glaxo's Avandia Coverup"
- Glaxo's Avandia Cover-Up | Mother Jones
GSK's actions "reflect a consistent pattern of objectionable behavior," Steve Nissen, chmn of Cleveland Clinic cardiology dept. They actively tried to hide this information from doctors & patients resulting in injury & death to 50k to 200K pa
2-1-13NYTimes--Johnson & Johnson Accused of Blocking Generic Cancer Drug
- Europe Says Johnson & Johnson Paid to Delay Generic Fentanyl - NYTimes.com
Johnson & Johnson and Novartis were accused of colluding to delay the availability of a less expensive version of a pain medication for cancer patients.
1-20-12NYTimes--A Big Win for Amgen and a Loss for Taxpayers
- Medicare Pricing Delay is Political Win for Amgen, Drug Maker - NYTimes.com
A provision buried in the fiscal bill passed earlier this month gives Amgen, the world’s largest biotechnology firm, more time to sell a lucrative kidney dialysis drug without price restraints.
7-2-12CBSNews--GlaxoSmithKline Pays $3 billion to Settle Criminal and Civil Fraud Charges
- GlaxoSmithKline agrees to $3 billion settlement with Justice Department in largest sum of its kind o
GlaxoSmithKline pleads guilty to unlawfully promoting the antidepressant drugs Wellbutrin and Paxil, and not reporting safety data on diabetes drug Avandia Read more by Ryan Jaslow on CBS News' HealthPop.
7-3-12NYTimes--GlaxoSmithKline Guilty in Criminal Case
- GlaxoSmithKline Agrees to Pay $3 Billion in Fraud Settlement - NYTimes.com
GlaxoSmithKline will plead guilty to promoting two drugs for unapproved uses and to failing to report important safety data about a diabetes drug.
4-12-12NYTimes--Johnson and Johnson Fined $1.2 Billion for Concealing Hazards of Antipsychotic Drug Risperdal
- Drug Giant Is Fined $1.2 Billion in Risperdal Case - NYTimes.com
A judge fined Johnson & Johnson and a subsidiary after a jury found that the companies minimized or concealed the dangers associated with Risperdal, an antipsychotic drug.
1-15-12NYTimes--Federal Government Will Require Drug Companies to Report Payments to Doctors
- U.S. to Tell Drug Makers to Disclose Payments to Doctors - NYTimes.com
To head off medical conflicts of interest, the companies would be required to disclose what they pay doctors for research, consulting, speaking, travel and entertainment.
4-9-11NYTimes--Johnson & Johnson Coughs Up $70 Million to Settle Criminal Charges of Bribing European Doctors
- Johnson & Johnson Settles Bribery Case - NYTimes.com
The company will pay $70 million to settle a complaint that it paid bribes and kickbacks to win business overseas.
3-9-11NYT--Ethics Survey for Doctors
- Ethics Survey for Doctors - NYTimes.com
First, do no harm? For some doctors that may not be the case, at least when money is involved. A new study of thousands of doctors found that just 8 of 10 strongly agreed that they should put patient welfare before their own financial interests.
12-5-10NYTimes---Abbott Labs, St.Joseph Medical Center, Cardiologist, Dr.Mark Midei Accused of Unnecessary Procedures
- Abbott, Cardiologist Dr. Mark Midei, St. Joseph Medical Center Accused of Installing Unneeded Stents
What was going on in Baltimore is going on right now in every city in America, said Dr. Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic, who said he routinely treats patients who have been given multiple unneeded stents....
9-14-10NYTimes--Medical Industry Ties Often Undisclosed in Journals
- Medical Device Companies Paying Millions to Doctors for Articles in Medical Journals
Five medical device companies paid $250 million to consultants for medical articles in 2007, including royalties. Zimmer paid $87 million; DePuy Orthopaedics, $63 million;Stryker, $45 million; Biomet,$27 million; and Smith & Nephew, $24 million.
8-13-10NYTimes--Merck, Johnson & Johnson, GlaxoSmithKline, Eli Lily, Medtronic Under Investigation for Overseas Bribery on Drug Tests
- Drug Companies Under Investigation for Bribery Overseas in Violation of Foreign Corrupt Practices Ac
At least a dozen big drug and device makers are under investigation by federal prosecutors and securities regulators in a broadening inquiry of bribery as to whether the companies may have made payments to foreign doctors and health officials.
7-22-10NYTimes--Harvard Medical School Belatedly Limits Payments By Drug Companies to Faculty
- Big Pharma Reined in at Harvard Medical School
Professors at Harvard Medical School will no longer be able to take industry money to speak for drug or medical device companies or accept gifts, travel or meals under a new conflict-of-interest policy announced Wednesday.
2-23-10 NYTimes--Is Something Rotten in Denmark (Glaxo)?
- Serious Questions Raised Anew about Glaxo's Avandia
The battle over Avandia has begun anew, and issues raised in the meeting between the four executives and Dr. Nissen are likely to be raised again. During the meeting, Glaxo executives promised to begin a crucial analysis of the safety within days.
Why is Manoj Smiling?
NYTimes 1-16-10 Johnson & Johnson Accused of Drug Kickbacks
- Johnson & Johnson Accused of Drug Kickbacks
Johnson & Johnson paid kickbacks to the nations largest nursing home pharmacy to increase the number of elderly patients taking the antipsychotic Risperdal and other medications, according to a complaint filed 1-15 by the U.S. Atty. in Boston.
11-3-09 NYTimes Eli Lily Pays Off 3,971 Doctors Indluding One from Stanford Medical School
- Dr. Manoj V. Waikar, of Stanford Medical School on the Payroll of Lily and Other Drug Companies
Dr. Waikar, a psychiatrist in Palo Alto, Calif., is also an adjunct clinical instructor in the department of psychiatry and behavioral sciences at the Stanford University School of Medicine.
How to cheat at everything.
11-3-09 NYTimes Health Reform and Doctor's Conflicts
- Health Reform Bills Aim to Curb Doctors' Conflicts Over Drug Company Payments
The targets are common business practices like drug company payments to doctors for speeches and consulting services, which have the potential to influence patient care and drive up the nations medical bills.
Conflicts of Interest at Harvard Medical School??
Comment on Harvard Alumni Magazine article 9-15-09
September 15, 2009
I’m glad that President Drew Faust “is on it” wrt Harvard’s financial situation and endowment. However, I would have liked to hear that she’s “on it” wrt the shameful conflicts of interest arising out of improper financial relationships between Medical School professors and drug companies. The fact that the Medical School recently adopted a policy requiring advance permission from the school administration from students for contacts with the media indicates that the School has not come to grips with the situation, even though the policy has been rescinded. Newspaper accounts that Dean Jeffrey Flier sees no conflicts indicate that the matter requires the attention of President Faust and the Board of Overseers. Perhaps a search committee for a new dean should be established.
ralph deeds, MBA 1960
Vermont Passes Law Requiring Disclosure of Payments to Doctors NYTimes 5-19-09
- Disclosure of Medical Industry Payments to Doctors Required by New Vermont Law
The law, scheduled to take effect on July 1, is believed to be the most stringent state effort to regulate the marketing of medical products to doctors. It would also ban nearly all industry gifts, including meals, to doctors, nurses, medical staff,
4-29-09 Institute of Medicine Calls for Doctors to Stop Taking Gifts from Drug Makers
The Institute of Medicine issued a critical report calling for doctors to stop taking money, free drug samples and other gifts from drug and medical device companies. "It is time for medical schools to end a number of long-accepted relationships and practices that create conflicts of interest, threaten the integrity of their missions and their reputations, and put public trust in jeopardy," the report concluded.
The report calls on Congress to pass legislation that would require drug and device makers to publicly disclose all pamyments made to doctors.
Drug companies spend billions of dollars wooing doctors--more than they spend on research or comsumer advertising. Much of this money is spent on giving doctors free drug samples, free food, free medical refresher courses and payments for marketing lectures. the Institute's report recommends that nearly all of these efforts end.
In a tiny nod to appease critics, last year several major drug companies agreed to stop giving pens, pads, and other gifts of small value, but defended other practices as valuable to doctors and patients. Here's a link to a NY Times article by Gardiner Harris on the Institute of Medicine's highly critical report.
Are Big Drug Companies Bribing Our Doctors and Medical Researchers?
Minnesota is the first of a few states to require drug companies to disclose payments to doctors. The records of these payments are quite revealing. From 1997 to 2005 drug makers paid more than 5,500 doctors, nurses and other health care workers in Minnesota at least $57 million. Another $40 million went to clinics, research centers and other organizations. The median payment per consultant was $1,000; more than 100 people received more than $100,000.
Doctors typically receive money for delivering lectures about drugs to other doctors. Some of the doctors receiving the most money sit on panels that prepare guidelines inctructing doctors nationwide about when to use medicines.
"I hate to say it out loud, but it all comes down to ways to manipulate doctors."
Kathleen Slattery-Moschkau, former sales rep for Bristol-Meyers
"If a doctor says that he got flown to Maui, stayed at the Four Seasons--and it didn't influence him a bit? Please."
Jamie Reidy, a drug sales rep for Pfizer and Eli Lily who was fired in 2005 after writing a humorous book on his experiences.
"You're paying him for the talk. You're increasing his referral base so he's getting more patients. And you;re helping to develop his name. The hope in all this is that a silent quid quo pro is created. I've done so much for you, the only think I need from you is that you write more of my products."
Gene Carbona, who left Merck as a regional sales manager in 2001.
Between 1997 and 2005, Dr. Grimm earned more than $796,000 from drug companies. In 2003 alone, Pfizer paid Dr. Grimm more than $231,000. Pfizer markets Lipitor, a cholesterol drug that last year had $12.9 billion in sales, more than any other drug in the world.
Dr. Donald Hunninghake served on a government-sponsored advisory panel that wrote guidelines for when people should get cholesterol-lowering pills. The panel's 2004 recommendations that far more people get the drugs became controversial when it was revealed that eight of nine members had financial ties to drug makers. The full extent of those ties have never been revealed.
In 1988 alone, Pfizer paid Dr. Hunningshake $147,000, and he earned at least $420,000 from drug makers between 1997 and 2003.
Comment: Judges are expected to disqualify themselves from cases in which they have a personal interest or even an appearance of bias. Apparently medical ethics don't include such a rule or expectation.
Here's a link to a 3-21-07 NYTimes story by Gardner Harris and Janet Roberts:
Secret Drug Company Payments to Doctors
Physicians Bribery a Look at This Common Medical Industry Practice
The Journal of the American Medical Association Says Doctors Should Stop Taking Bribes from Drug Companies
IN SOME STATES THE MAKER OVERSEES THE USE OF ITS OWN DRUG
- Drug Companies Oversee Use of Their Drugs
Conflict of interest? Hidden agenda? Or legitimate cost containment mechanism?