More bad news for workers. According to a report by The Employee Benefit Research Institute, between December 2007 and April 2011, the number of individuals with health insurance from 60.3% to 55.8%. Most uninsured workers reported that the reason they lacked coverage was cost.
Employer-based health insurance are the most common form of heath insurance for working Americans. Since the 1980s, the percentage of individuals without heath insurance has increased, in large measure due to high premium costs on employers. The general trend of in the percentage of uninsured workers reporting cost as a reason for not having coverage has increased steadily since 2008.
Between 2003-2007, the percentage of workers who were offered dependent coverage also dropped to 16 percent.
Wednesday, May 23, 2012
Drug Maker Fined AGAIN for Illegal Marketing Practices
Abbott Laboratories reached a
settlement with the Justice Department and several states over illegal
marketing practices for its anti-seizure drug Depakote, in which Abbott will
pay $1.6 billion in criminal and civil fines. The announcement generated heavy
media coverage, including a brief mention on ABC World News.
ABC World News reported,
"Tonight one of the largest drug companies, Abbott Laboratories, has
agreed to a staggering settlement. Today $1.6 billion in criminal and civil
fines for improperly marketing the anti-seizure drug Depakote in nursing homes.
The company convinced the nursing homes to use the drug to treat aggression in
dementia patients, despite the lack of credible evidence that the drug was
effective for that use."
The
New York Times reports, "The
settlement comes as the Justice Department and the states have increased
scrutiny of the sales and marketing practices of pharmaceutical companies,
particularly in cases in which they market drugs for uses that are not approved
by the Food and Drug Administration."
The
Wall Street Journal reports that in
addition to the fines, Abbott would plead guilty to a misdemeanor charge of
violating a federal drug law.
The Washington Post notes the settlement "is the
second-largest in a string of multimillion-dollar payouts in recent years
resulting from stepped-up enforcement by the Justice Department and state
investigators against drug makers that 'misbrand' their products. The company
will to plead guilty to one misdemeanor violation of the Food, Drug and
Cosmetic Act for misbranding. Abbott also agreed to a five-year probationary
period in which it must report any probable violations of the law to the
probation office."
The
Chicago Tribune reports, "As
part of the settlement agreement, North Chicago-based Abbott said it would pay
$800 million to resolve civil cases brought by federal and state governments,
$700 million in criminal penalties and $100 million to states to resolve
consumer protection matters. The company will plead guilty to one misdemeanor
violation of the Food, Drug and Cosmetic Act for misbranding. Abbott also
agreed to a five-year probationary period in which it must report any probable
violations of the law to the probation office."
The Chicago Sun-Times reports, "The company admitted
that it trained a specialized sales force to promote Depakote in treating
dementia because the drug was not subject to federal regulations designed to
prevent the use of unnecessary medications in nursing homes."
Friday, March 30, 2012
FDA to Convene Meetings in June to Review and Discuss Metal on Metal Hips
Fda (Photo credit: Wikipedia)
Metal hip joints have been under scrutiny due to reports of
pain and swelling that have sometimes required removal. In 2010, Johnson
& Johnson recalled roughly 93,000 implants. The FDA already asked
device companies to conduct additional follow-up studies to monitor problems
with the implants.
The agency says it will hold a two-day meeting beginning
June 27 to consider whether more rigorous testing standards are needed.
Earlier this month, British experts said doctors should stop
using metal hip joints because data show they have to fixed or replaced more
often than older implants.
Orthopedic Surgeon Becomes Victim of Depuy Hip
Logo of CBS News (Photo credit: Wikipedia)Dr. Stephen Tower, an orthopedic surgeon, became a victim of a the Depuy ASR hip which has been recalled and my claim was defectively designed, tested, manufactured, and represented to consumers. The FDA had cleared the device without testing based on "substantial equivalence" to earlier similar devices. Use of metal parts over plastic was supposed to give the patient more mobility so they could participate in all kinds of physical activity.
After a year, he had high levels of chromium and cobalt in his blood and his hip was constantly painful. He started having other problems like disturbed sleep, mood swings, anxiety, hearing loss, and tinnitus, constant ringing in the ears. The symptoms got so bad he couldn't go to work. Even though he kept calling the DePuy engineers, they claimed they never had any problems with the device. Then a British Medical Journal and BBC Newsnight investigation revealed that millions of people with similar implanted devices also had high levels of toxins seeping into their bloodstream.
HealthPop reported that the investigation showed that the chromium and cobalt ions leak into surrounding tissue and destroy muscle and bone, eventually spreading to lymph nodes, the spleen, liver and kidneys and potentially causing damage. The ions also had the ability to change a person's chromosomes, meaning genetic changes.
Tuesday, March 27, 2012
Biomet Busted for Bribery
Biomet (Photo credit: Wikipedia)According to the Washington Times, "The Justice Department's Criminal Division announced Monday that the Indiana-based company, which manufactures and sells medical devices worldwide, made various improper payments or paid bribes from 2000 to 2008 to health care providers in Argentina, Brazil and China to secure lucrative business with hospitals." "During this time, according to information filed in US District Court in Washington, more than $1.5 million in direct and indirect payments were made. Modern Physician reports, "These payments were then falsely recorded as commissions, royalties, consulting fees or scientific incentives, according to the release."
Friday, March 23, 2012
Bloomberg: J & J Marketed Vaginal Mesh Without Approval
According to Bloomberg News writers David Voreacos and Alex Nussbaum, Johnson & Johnson sold a vaginal mesh implant for three years before U.S. regulators approved the device.
J&J’s Ethicon unit introduced the Gynecare Prolift device in March 2005, touting it in an annual report as an “innovative and effective surgical option” for weakened pelvic muscles.
Here is the problem. The U.S.Food and Drug Administration said it learned of the Prolift in 2007, when J&J sought approval for a related product. The FDA cleared both devices in May 2008.
Johnson & Johnson’s unauthorized sales might cost it more to resolve lawsuits over the product.
J&J’s unauthorized sales might cost it more to resolve lawsuits over the product. J&J already has endured recalls of artificial hip implants and over-the-counter drugs. Three J&J units have pleaded guilty in the past two years to bribery or illegal marketing of drugs. A fourth agreed to plead guilty in a marketing case.
This type of conduct again raises questions about the FDA’s approval process, which lets companies introduce products without human testing if the agency decides they’re similar to devices already for sale, or so-called predicates.
An FDA report in July found a fivefold jump in deaths, injuries or malfunctions tied to vaginal mesh for prolapsed organs. In September, an advisory panel urged the FDA to reclassify such mesh as “high-risk” devices needing human testing.
In Atlantic City, patients’ lawyers are seeking to interview more than 70 company witnesses, including Gary Pruden and Sheri S. McCoy, the leader of J&J’s pharmaceutical and consumer products unit. Both Pruden and McCoy previously served as company group chairman and worldwide franchise chairman of Ethicon.
J&J’s Ethicon unit introduced the Gynecare Prolift device in March 2005, touting it in an annual report as an “innovative and effective surgical option” for weakened pelvic muscles.
Here is the problem. The U.S.Food and Drug Administration said it learned of the Prolift in 2007, when J&J sought approval for a related product. The FDA cleared both devices in May 2008.
Johnson & Johnson’s unauthorized sales might cost it more to resolve lawsuits over the product.
J&J’s unauthorized sales might cost it more to resolve lawsuits over the product. J&J already has endured recalls of artificial hip implants and over-the-counter drugs. Three J&J units have pleaded guilty in the past two years to bribery or illegal marketing of drugs. A fourth agreed to plead guilty in a marketing case.
This type of conduct again raises questions about the FDA’s approval process, which lets companies introduce products without human testing if the agency decides they’re similar to devices already for sale, or so-called predicates.
An FDA report in July found a fivefold jump in deaths, injuries or malfunctions tied to vaginal mesh for prolapsed organs. In September, an advisory panel urged the FDA to reclassify such mesh as “high-risk” devices needing human testing.
In Atlantic City, patients’ lawyers are seeking to interview more than 70 company witnesses, including Gary Pruden and Sheri S. McCoy, the leader of J&J’s pharmaceutical and consumer products unit. Both Pruden and McCoy previously served as company group chairman and worldwide franchise chairman of Ethicon.
Consumer Reports: Americans want more oversight of Implanted Medical Products
Less than 1% of of implanted medical products are subjected to the strenuous PMA (pre-market approval) process of the FDA. And the draft legislation put together by the House Energy and Commerce Health Subcommittee would actually allow the approval process to go even faster. The Senate Health, Education, Labor and Pensions Committee's draft bill does provide some additional protections for patients once devices are on the market, but does nothing new to prevent potentially unsafe medical devices from being sold in the first place.
But according to a new poll by our publishing pals Consumer Reports, 82% of Americans believe that preventing safety problems is more important than limiting safety testing in order to prevent delays and encourage innovation.
91% of poll respondents said each implant should be safety tested before being sold even when similar implants were in use.
71% said that a new device should not be allowed to be sold based on its similarity to an existing implant that has a safety problem or has been recalled.
94% indicated that medical device makers should be required to do long-term monitoring of implants if there are safety concerns or problems with a particular device. Existing law gives the FDA only limited authority to require such long-term safety monitoring.
95% said that effective consumer protections for medical implants should include a nationwide system for tracking medical implants so patients can be notified about safety problems or recalls. No such system currently exists in the U.S. even though it was required by Congress' previous reauthorization of the law.
66% indicated a high level of concern about safety decisions or recommendations made by expert committees that included doctors who had current financial relationships with medical device makers.
Industry lobbyists have been pushing lawmakers to weaken current rules designed to prevent such conflicts of interest. The Senate and House discussion drafts remove current caps on the percentage of expert committee members that can be granted waivers if they have a conflict of interest, a provision championed by consumer advocates five years ago.
"Recent problems with metal hip implants and surgical mesh have shown how our current system fails to ensure medical devices are safe and effective," said Lisa Swirsky, senior policy analyst for Consumers Union. "Unfortunately, the House bill weakens current standards to speed up device approvals rather than improving safety oversight. The Senate bill offers some improvements but it should be strengthened to require stricter safety testing of new implants and life sustaining devices. Congress should recognize that the public is far more concerned about making sure devices are safe and work than how quickly they are made available."
The Depuy hip problems came to light, in part, due to tracking systems in place in other countries, which indicated higher than normal failure rates. In this country, the information received by doctors is often limited to data provided by the manufacturer and their sales representatives, which is often times false and misleading.
As one of my clients told me this morning, "I don't need a doctor to tell me that my hip has failed and needs to be removed, I live it every day."
But according to a new poll by our publishing pals Consumer Reports, 82% of Americans believe that preventing safety problems is more important than limiting safety testing in order to prevent delays and encourage innovation.
91% of poll respondents said each implant should be safety tested before being sold even when similar implants were in use.
71% said that a new device should not be allowed to be sold based on its similarity to an existing implant that has a safety problem or has been recalled.
94% indicated that medical device makers should be required to do long-term monitoring of implants if there are safety concerns or problems with a particular device. Existing law gives the FDA only limited authority to require such long-term safety monitoring.
95% said that effective consumer protections for medical implants should include a nationwide system for tracking medical implants so patients can be notified about safety problems or recalls. No such system currently exists in the U.S. even though it was required by Congress' previous reauthorization of the law.
66% indicated a high level of concern about safety decisions or recommendations made by expert committees that included doctors who had current financial relationships with medical device makers.
Industry lobbyists have been pushing lawmakers to weaken current rules designed to prevent such conflicts of interest. The Senate and House discussion drafts remove current caps on the percentage of expert committee members that can be granted waivers if they have a conflict of interest, a provision championed by consumer advocates five years ago.
"Recent problems with metal hip implants and surgical mesh have shown how our current system fails to ensure medical devices are safe and effective," said Lisa Swirsky, senior policy analyst for Consumers Union. "Unfortunately, the House bill weakens current standards to speed up device approvals rather than improving safety oversight. The Senate bill offers some improvements but it should be strengthened to require stricter safety testing of new implants and life sustaining devices. Congress should recognize that the public is far more concerned about making sure devices are safe and work than how quickly they are made available."
The Depuy hip problems came to light, in part, due to tracking systems in place in other countries, which indicated higher than normal failure rates. In this country, the information received by doctors is often limited to data provided by the manufacturer and their sales representatives, which is often times false and misleading.
As one of my clients told me this morning, "I don't need a doctor to tell me that my hip has failed and needs to be removed, I live it every day."
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