GlaxoKlineSmith plans to remove zinc from certain Super Poligrip products, The New York Times reports. The product lines include Super Poligrip Original, Super Poligrip Ultrafresh, and Super Poligrip Extra Care. An estimated 3.5 million households use these products yearly. Glaxo will continue to sell its Super Poligrip Free, which doesn't contain zinc. This comes at a troubling time for the UK-based pharmaceutical giant. Glaxo's Avandia is under heavy scrutiny for its link to heart-attack deaths. Also, on February 18th the FDA issued new guidance measures urging physicians to switch asthma patients away from medicines like Glaxo's Advair because of the possibility that the asthma medication actually worsens asthma conditions long-term. Investors are even starting to take notice of Glaxo's mounting problems with patient safety, with its stock sliding despite a $2.6 billion dollar profit last quarter alone.

The voluntary recall comes after a University of Texas research study in 2008 found that users of denture cream with zinc had excess levels of zinc in their blood. A high zinc concentration in a person's blood over several years can lead to zinc toxicity and significant neurological problems. Interestingly, GlaxoSmithKline only began disclosing the zinc in their denture creams after the University of Texas' study was published in the medical journal Neurology, but gave no specific warnings to consumers.

Glaxo issued a statement on their website on February 18, 2019, regarding their voluntary, precautionary recall claiming that health problems only occur when consumers use more than the directed amount of denture cream. However, this statement is wholly inadequate. First, there were no appropriate, specific warnings to consumers about the possible dangers of developing zinc toxicity by using excess denture adhesives containing zinc. Second, it seems fundamental that the company would have to consider that many consumers use denture creams with zinc while taking other supplements containing zinc --- easily contributing to consumers developing above-average levels of zinc over time. There is no question that zinc is an important part of our diet. However, Glaxo's official stance that increased zinc intake stems only from consumers who misuse their product is laughable. In reality, it's the company's lack of foresight or common sense that has brought upon another major health concern over one of its consumer products.

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Avandia is a prescription drug marketed by GlaxoSmithKline (GSK). Released to the U.S. market in 1999, Avandia has been used by millions of Americans to treat Type II diabetes. It works by helping to control blood sugar levels by making the cells of the body more receptive to insulin.

In 2007, though, Dr. Steven Nissen published a meta-analysis of Avandia in The New England Journal of Medicine. His study data was alarming in that it found Avandia patients had a 43% higher risk of heart attack. Glaxo downplayed the report, saying Dr. Nissen's methods were not scientifically conclusive. Nonetheless, Dr. Nissen's report drew attention of Washington. The U.S. Senate Committee on Finance conducted an independent review to determine what Glaxo knew about Avandia before the study was published in the New England Journal of Medicine.

Significant (and shocking) findings by the Senate committee after reviewing hundreds of thousands of pages of internal GSK documents concluded:

"The totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public.... Based on this knowledge, GSK had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner. Instead, GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug ACTOS (pioglitazone) might reduce cardiovascular risks."

Even though the FDA decided not to pull the drug in 2007 when it was up for review, it concluded that Avandia had caused 83,000 heart attacks between 1999 and 2007. Dr. Nissen has sent the New York Times secretly recorded conversations between himself and executives at Glaxo prior to publishing the report. In the meeting, executives promised to begin a thorough analysis of the link between Avandia and heart attack risk "within days" - and three years later, no such report has published in any journal. Dr. Nissen further believes he was trying to being pressured and persuaded not to publish his findings.

Glaxo says it's open to scientific debate, but so far it seems that Glaxo has only (1) downplayed scientific evidence finding increased risks of heart attack; (2) pressured scientists to not publish scientific data which would affect Avandia sales negatively; and (3) stressed, without scientific support, that Avandia is the safest alternative Type II diabetes medication on the market.

As this story continues to unfold in the weeks ahead, it again highlights broader issues of patient safety. A pharmaceutical company, especially one which is publically traded (Glaxo is publicly traded), has one overriding goal: profit. When disclosing safety concerns might materially impact the company's ability to profit, or dramatically decrease revenue from a particular drug, time and time again these companies choose to skew evidence and downplay side effects. They skirt, manipulate, and sometimes downright defy the law, all in the name of profit.

Glaxo is not the first pharmaceutical company to hide evidence or knowingly market dangerous drugs (anyone remember the Vioxx debacle? Or, perhaps HRT or fen-phen??). And until FDA becomes more proactive in regulating these companies and ensuring independent oversight, more unnecessarily dangerous drugs will continue to be marketed in the U.S.

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In traditional hospitals, patients have an attending physician or doctors on staff to treat them in the event that their condition worsens. Unfortunately, Medicare loopholes have created an industry of so-called "long-term hospitals" where extended-stay patients are transferred to from traditional hospitals. There are over 400 of these long-term care hospitals across the U.S. One company, Select Medical Corporation, alone has eight locations throughout Florida. These "hospitals" usually do not have an overnight physician on staff. And in the event of an emergency, physicians are called from outside the hospital.

While some long-term hospitals are not-for-profit, most are. The previously mentioned Select Medical Corporation is a for-profit, publically traded company specializing in long-term care hospital management. While Select's profits soar, whistleblowers within the company expose the management's lack of adequate training and quality standards. A recent New York Times investigation reports countless examples of downright gross negligence by Select. It's a widespread problem, with reports showing Select Medical Care has committed four times the national average of Medicare violations on a per-bed basis.

Proponents of long-term care hospitals say while traditional hospitals help patients survive acute illness, they are not equipped for long-term care. Discharging the patients to long-term care hospitals, they say, would be more appropriate. But the reality is, the motive is profit. Under Medicare payment rules, normal hospitals have a financial disincentive to keep patients for long periods of time because Medicare begins paying the hospital less money after 25 days. Meanwhile, long-term facilities have a financial incentive to take these patients, and are subject to less Medicare oversight due to their nature as a "specialized" care facility. The normal hospital frees up a bed for a new patient (which Medicare would pay more for), while Medicare pays the long-term care facility receiving the patient an average of $40,000 for patient care. This amounts to a staggering burden on the Medicare system, projected to be $4.8 billion dollars this year alone.

The long-term care hospital market was founded based on loopholes in the Medicare rules and has been exploited to an alarming level. Medicare reform is long overdue, and absolutely must address the issue of long-term care hospitals. It's vital that the legislature continue to close the loopholes which allow these companies to skirt the rules and severely jeopardize patient lives only to increase profit margins slightly.

If someone you know has been admitted to a long term care facility, research the company as much as you can before placing a loved one. By doing so, you'll probably know more about it than Medicare administrators.

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Casting for Recovery is a national, non-profit organization offering retreats for women who have or are recovering from breast cancer. The weekend retreat program promotes healing by combining fly-fishing and catch-and-release lessons with counseling and education. The program, started in 1996 by breast cancer survivor Lori Simon, now operates in 27 states. Since its inception, the program has remained completely free to accepted applicants. High demand and limited spots have forced the program to turn away many eligible applicants.  Fortunately, that’s about to change.

Hartford Group, Casting for Recovery’s lead supporter since 2006, has pledged enough support for the program to expand into all 50 states. This expansion comes in a time where many other nonprofit organizations are struggling to survive. Nonetheless, the program’s effectiveness and high demand has caught Hartford Group’s attention. Connie Weaver, vice president of marketing and communications, had this to say: "You need only hear one woman's story of how her life was changed by attending a retreat to know why we decided to become the organization's leading national supporter three years ago. It is a privilege to be a part of a process that enables a woman to move forward after breast cancer surgery and to continue the process of renewal."

Lori Simon, now the program’s executive director, says that the organization will still need to more than a 1,000 volunteers to effectuate the expansion. Simon’s not worried, though, stating "breast cancer touches just about every family in America. So when the call goes out for volunteers, people from all walks of life step up."

For Floridian breast cancer survivors: Casting for Recovery is currently accepting applications for its November 5-7 retreat in Titusville, FL. Applications are due by August 27. Check their website for more information.

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The procedures and policies in place to train orthopedic surgeons need serious changes to meet growing demand and patient care, this according to an article in the January issue of The Journal of Bone and Joint Surgery. The article was written by researchers at the Hospital of Special Surgery (HSS).  January issue of The Journal of Bone and Joint Surgery published a study by researchers at Hospital of Special Surgery (HSS).

Dr. Laura Robbins, the HSS vice president of education and academic affairs, said this about the report: “Before this study, we at Special Surgery thought that we were the only hospital dealing with these complicated challenges. As a result of this study, we have come to realize that as a nation, the prominent training programs around the country are grappling with these same issues.”

One of the chief concerns, according to the report, is the work-hour restrictions set in place by the Institute of Medicine. The rules strictly prohibit resident trainees to work more than 24 hours, have shift breaks, and one day off every seven. While over-working resident trainees is a valid concern, strict rules like these prevent the resident from treating the patient from pre-surgery to post-surgery. This creates discontinuous care, which not only could jeopardize patient care, but also the effectiveness of training.

Additionally, the report points out that gender and generational changes among orthopedic surgeons have created new challenges. Many programs do not provide up-to-date training techniques, such as electronic technology, to help better provide the trainees with the flexibility and effectiveness they desire. In short, orthopedic programs are unable to keep up with the evolving needs of trainees.

Finally, another major concern in the report is antiquated restrictions look to jeopardize patient care and further burden current resident surgeons. The number of trainees that programs can accept has been capped for at the same level for 20 years, even while demand has increased significantly. Dr. Robbins commented on the finding, saying “we know from projections in studies that there won't be enough orthopedic surgeons in the future for the baby boomers who will need joint replacements.”

These are all very valid concerns, and really demonstrate the balancing act caregivers and policymakers must strike in order to ensure patient care. Later this year, when the researchers reconvene to make substantive recommendations, it will likely be a much-needed step forward in the orthopedic surgery field. Until then, the risk of under-trained and overworked orthopedic surgeons is simply too great.

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For patients with a high risk of cardiac-related death, implantable cardioverter-defibrillators (ICDs) are usually a demonstrably favorable alternative to medication. Rather than taking medication, an ICD is implanted in a patient and will monitor the patient’s heartbeat. When an irregularity is detected, the ICD will administer a shock which should correct it. During implantation, the ICD is connected directly to heart by thing wires, called leads.

In December 2007, Medtronic, a major manufacturer of defibrillator leads, was forced to recall their latest model of leads, the Sprint Fidelis, because of reports of lead fractures. If fractured, the ICD is unable to function properly, and may either give unnecessary shocks or none at all. Clearly, this creates a significant health risk for patients in need. The danger becomes worsened by the fact that the surgery to remove or replace the leads is not without risk. In a March 2009 investigation by the New York Times, it was reported that at least 13 people were likely killed due of the faulty leads or during surgery to replace the defective leads.

Since the initial recall, the rate of failures has continually increased. So much so, UBS Analysis’ predict that the rate of failure at four years could be as high as 30%. This would be an astounding failure rate and will jeopardize patient health, and many patients would be required to undergo medium-risk surgery to replace the wires.

The monumental failure of the Sprint Fidelis brings to light FDA’s failings in its approval processes. When a company makes a minor change to an FDA approved device, it must seek new approval from the FDA. However, the threshold for a supplemental device is lower and the FDA has a much higher tendency to approve this type of device as opposed to new device applications. Because of this, companies have an incentive to seek approval of new devices claiming they have only been slightly altered from an already approved device.

When Medtronic released the Sprint Fidelis series, Medtronic advertised it as the next generation of lead wires. The Sprint Fidelis was advertised as thinner and easier to implant compared to the Sprint Quattro. It replaced their previous line of wires, the Sprint Quattro line. Despite the seemingly significant changes, Medtronic claimed to the FDA that the changes from the Sprint Quattro were only minor. Shortly after, the FDA approved the Sprint Fidelis based its approval of the Sprint Quattro. So while Medtronic told the FDA the changes were only minor, it went on to flaunt the changes as significant improvements over the previous line of leads.

The severity of this disaster only worsens as more patients experience failures. This situation reiterates the need for significant FDA reform. In this case, the FDA needs to ensure that a manufacturer is not advertising “significant improvements” to the public while declaring the changes only minor to the FDA. And in the least, the FDA must do a better job at thoroughly reviewing supplemental applications before approving them.  After all, sometimes the changes aren’t so minor.

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Dr. Rita Redberg and her colleagues at the UCSF Medical Center have published a startling report regarding the FDA’s approval of cardiovascular drugs. According to the report, from 2000-2007 the FDA approved 78 cardiovascular devices with relatively little evidence.

In fact, nearly two thirds of the pre-market approvals were supported only by a single research study. Additionally, only 27% were randomized tests, and only 14% were approved.  Only 5%, or 4 out of 78, used more than one blinded, randomized studies. Nearly nine in ten of the studies relied on surrogate endpoints, which are sometimes misleading.

These numbers and statistics mean that the FDA approved a significant number of cardiovascular devices based on only one report. And many of the reports used it its approval were based on clinical methods widely considered inadequate.

While new surgical procedures do not require any FDA approval and new drugs have strict approval requirements, devices fall somewhere in between the two. Dr. Redberg suggests that the standards of device approvals should be higher than drugs, because "because [devices] are implanted and cannot simply be discontinued, as drugs can."

Less than strict approval requirements for devices affects a significant number of recipient patients, since once a device is approved the manufacturer almost always begins encouraging widespread use. Meanwhile, the GAO recently reported that the while the FDA is improving its post-market procedures, it is still understaffed and ill equipped to pull approved drugs and devices from the market quickly when necessary.

This has created a troubling situation: inadequate device approval requirements, and a deeply flawed post-market monitoring system. This is all the more reason that the FDA needs substantial reform, and it needs it soon.

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The Government Accountability Office (GAO) has compiled a report looking at the steps the FDA has been taking to improve communication between the internal offices of the FDA, in an effort to protect the public from dangerous drugs released on the U.S. market. The GAO found some FDA efforts towards this goal, including having done or planning to:

·         Improve communication between the Office of Surveillance and Epidemiology (OSE, once called Office of Drug Safety) and Office of New Drugs (OND).

·         In 2010, implement new data systems facilitating quicker access to outside data, in order to facilitate “timeliness, quality, and analysis of reports of adverse events associated with human drug use.”

·         Improve funding for private contracts to provide external data for speedier access.

But is this enough? Within the FDA, scientists in the OND are tasked with reviewing, and ultimately approving, new drug applications. These same scientists are also the ones who (generally) make the determination whether to pull the same drugs off the market. Meanwhile, the OSE monitors the drug’s side-effects on the market and compiles patient complaints. However, the OSE doesn’t have much say in whether the drugs should be pulled from the market. Many outsiders would point to this bureaucratic setup as improper – to have the same scientists which approved the drug also have to be the ones puts the public at risk.

Additionally, the GAO reports that both the OND and OSE are understaffed. Both offices’ employees cite the inability to meet their responsibilities. According to the GAO the OSE must double its employees in the next year in order to keep up with workload. All of this means that both the OND and OSE are understaffed and overworked; and as a result are unable to fulfill their responsibilities.

It’s important to remember that the GAO is fully independent of the FDA, the pharmaceutical industry, and trial lawyers. In fact, it’s an investigative arm of Congress, funded by taxes. There is no incentive for the GAO to fabricate or exaggerate in any direction, and their reports should be taken as truthful and honest. Knowing this makes their reports about the inadequacies of the FDA all the more alarming. While the GAO reports the FDA is going in the right direction, it still has a tremendous amount of ground to make up. And the FDA needs to do much more to distance itself from the pharmaceutical industry. And until this happens, some Americans are at risk of taking FDA-approved medications which should not be on the market.

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The American Recovery and Reinvestment Act allocated $1.1 billion dollars to coordinate research and guide investments in comparative research funded by the Act. Some critics suggest that a whole lot of money could have been saved just by looking to the FDA.

Dr. Lisa Schwartz and Dr. Steven Woloshin have co-authored a New England Journal of Medicine article titled Lost in Transmission – FDA Drug Information That Never Reaches Clinicians, in which they talk about the fallacies of the current system, and possible ways to correct it.  Primarily, on the journey from clinical trials to FDA approval to the production of a drug label, potentially vital information is lost.  For example, the FDA approved the drug Rozerem in 2005 to treat chronic insomnia, but in one phase 3 clinical trial, the drug failed to provide any benefit at all for this condition.   In fact, a memo created by the FDA’s own medical review team debated whether to even approve the drug since the insignificant benefits provided by the drug may be outweighed by its potential side effects, but Rozerem was eventually approved.  Obviously, knowing this background information would certainly appear to have an effect on a doctor’s enthusiasm to prescribe the drug, and a patient’s willingness to take the drug. Unfortunately, though, this type of important information is not placed on the FDA’s approved drug label, so none of it is clearly communicated to the public.

To its credit, the FDA has issued new guidelines about drug labeling, such as including phase 3 trial results and other effectiveness data, but this information is not mandated as it should be.  In the case of Rozerem, the effectiveness data is still absent even after the label was updated. Bottom line - more needs to be done.

The FDA is currently undergoing a pilot test of a “drug fact boxes” which would include a succinct table of effectiveness data such as reviews and labels. This would give doctors more pertinent information about drugs and also allow patients to make a more educated decision before they take a new medication. The FDA is still debating internally how to use these “drug fact boxes.”

There are other potential alternatives, but the authors concisely (and correctly) conclude, “Whatever approach the agency adopts, it needs a better way of communicating drug information to clinicians. We don’t need to wait for new comparative-effectiveness results in order to improve practice. We need to better disseminate what is already known.”

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The Government Accountability Office (GAO) has released a new report about the FDA’s lack of post-marketing oversight in a number of the drugs which it conditionally approved.

The FDA normally makes a decision to approve a drug based on clinical trials. If the clinical trials yielded favorable results, the FDA would then likely approve the drug and sales of the drug can be introduced to the U.S. market. The downside to this traditional route, though, is that the clinical trials can take years to complete, and cost the pharmaceutical company millions of dollars.   With this in mind, in 1992 the FDA instituted an optional route to approval: surrogate end-points. Surrogate end-points are the end-results yielded by a drug in a laboratory setting which tend to show positive health benefits. For example, HIV-related drugs are often approved based on its virus-lowering power, a major factor in increased survival for HIV-infected patients. A cholesterol drug could be approved to prevent heart disease, an end-point, by showing that the drug lowers cholesterol – since there is a connection between high cholesterol and heart disease. Utilizing this approval route means that manufacturers can get their drugs to the market faster and patients in need have faster access to the drug.

Unfortunately with surrogate end-point approval there are often many factors unknown, namely long-term effects of the drug’s usage. Long term clinical studies provide this information, but drugs using surrogate end-point trials are often approved so quickly that long-term effects are not known until the drug is on the market - which means that adverse effects may not be known until after the drug’s approval. As such, the FDA approves these drugs conditionally. This means that the FDA will require the manufacturer to conduct ongoing research beyond the drug’s approval, or else the drug’s approval will be revoked.

Despite all of these conditionally approved drugs requiring the conduction of post-marketing studies, the GAO found only 52% of these drugs actually have adequately completed them. 18% haven’t even started, 7% were still ongoing, and 2% were delayed. The remaining 21% were either not yet reviewed or found no longer necessary.

The GAO also noted the FDA’s inability to provide accurate record keeping of post-marketing research. Also, the GAO found that no drug approved under the surrogate-endpoint system has ever been unapproved, despite a large number of delinquent manufacturers.

This is not the first time the FDA has come under fire from the GAO. In 2006, the GAO chastised the FDA for its lack of a clear oversight process, and inability to quickly evaluate post-marketing data.  Clearly, the FDA has a responsibility to demand post-marketing studies be completed and submitted to prove a drug’s long-term safety and efficacy.

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A survey released by The Journal of the American Medical Association (JAMA) concludes that six of the top medical journals in the U.S. published a “significant number” of ghostwritten articles in recent years, reports the NY Times.  Ghostwriting in the medical profession generally means that the research or conclusions were not written by the credited author. A dangerously common practice in the medical industry is for a pharmaceutical company to pay a group of professional writers to produce papers, and then pay scientists or physicians to attach their names to these articles. Ghostwriting has been common for years, but has received harsh media attention, especially recently.   In late July, a federal judge ordered the unsealing of confidential court documents revealing that the pharmaceutical giant Wyeth orchestrated dozens of ghostwritten articles to promote their line of hormone replacement drugs.

According to the anonymous survey of 630 published medical papers, 11% of the articles in the New England Journal of Medicine were ghostwritten. Likewise, 7.9% of the articles in JAMA, 5% of the articles in The Annals of Internal Medicine, and 2% of the articles in Nature Medicine were ghostwritten. In reality, these statistics may actually be much higher, because ghostwriting is difficult to track due to its covert nature.

Many are calling for medical journals to step up enforcement of anti-ghostwriting policies. In an article written in response to the survey, PLoS Medicine editors have made a call to the industry to institute a zero tolerance policy – identifying and retracting any ghostwritten articles and banning those authors from future publications. There’s been swift congressional support too, with Senator Chuck Grassley (R – IA) telling reporters “objective research is really at the heart of public trust in medicine.” Senator Grassley has led the Congressional charge against ghostwriting in Congress, and strongly encourages medical journals to adopt strong anti-ghostwriting policies. 

Supporters of ghostwriting say that it allows articles to be released much sooner than otherwise, thus potentially getting medically sound data to the public as soon as possible. However, this data cannot, and should not, be relied upon to make medical decisions if there is a fundamental conflict of interest. The only way medical journals can protect their integrity is to take a very firm stance against ghostwriting, and institute strict policies to identify and combat it.

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Earlier this month, drug giant Pfizer agreed to pay a $2.3 billion penalty to settle claims over payment of kickbacks and illegal drug marketing and promotion that violated federal drug laws over an extensive period of time. The $2.3 billion settlement is the largest health care fine in U.S. history.  As part of the settlement, Pfizer will pay a $1.2 billion criminal fine,  a $105 criminal forfeiture, and pay another $1 billion to Medicaid, Medicare, and other federal healthcare programs.  The government said the Pfizer promoted four prescription drugs, including the pain killer Bextra, Geodon (anti-psychotic), Zyvox (an anti-biotic) and Lyrica (an anti-epileptic), as treatments for medical conditions different than those the drugs had been approved for by the FDA.

While it’s not uncommon for doctors to prescribe drugs for off-label medical conditions, drug manufacturers are strictly prohibited from marketing drugs for uses that have not been approved by the Food and Drug Administration. According to federal authorities, Pfizer encouraged its agents to wine and dine doctors in order to encourage prescribing the four drugs for off-label medical conditions. Pfizer officials even went so far as to create phony doctor requests for medical information in order to send unsolicited information to doctors about unapproved uses and dosages.

"Combating health care fraud is one of this administration's top priorities," Assistant Attorney General Thomas Perelli said in announcing the settlement. Perelli added the settlement illustrates ways the department "can help the American public at a time when budgets are tight and health care costs are rising."

The fraud and illegal conduct by Pfizer jeopardizes public health, corrupts medical decisions by health care providers, and wastes billions of government dollars.  Hopefully, this massive settlement will be a prime example of how far the government is willing to go to combat this egregious behavior and corporate greed.

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A group of tobacco manufacturers, including RJ Reynolds, Commonwealth Brands, Inc., National Tobacco Co., and Lorillard, sued the U.S. Government in August claiming the new federal law passed in June called the Family Smoking Prevention and Tobacco Control Act unconstitutionally restricts their ability to communicate with consumers and unfairly limits their ability to promote new tobacco products.   The new law gives the FDA broad powers for the first time for approving all new tobacco products (but not products already on the market), requires larger warnings on cigarette packages, and places harsh restrictions on tobacco advertisements.  The Plaintiff tobacco companies say the new law goes too far in restricting their commercial free speech rights.

“While the act is purportedly intended to reduce youth tobacco use, a number of its provisions broadly restrict all speech by plaintiffs about tobacco products,” according to the complaint.  Plaintiff Tobacco companies called some of the restrictions “egregious,” saying that Americans have “been well-informed of the harms of tobacco use” for decades.

Noticeably absent from the lawsuit was tobacco giant Philip Morris.  Interestingly, Philip Morris was a very enthusiastic backer of the new law and has been in favor of FDA regulation.  So if not all of Big Tobacco is rallying behind this lawsuit, what’s the true motivation for this suit? The answer’s clear. Philip Morris is the largest tobacco producer in the U.S., holding over 50% of the cigarette market share in the U.S. Meanwhile, RJ Reynolds and Lorillard control 28% and 11% of the market, respectively. And because the law adds new limits on the ways cigarette manufacturers can promote new products, RJ Reynolds and Lorillard adamantly declared that Philip Morris’ dominance will continue.

So is this lawsuit really a question about free speech and the government’s rights to limit advertising harmful products? Is it a question about the government’s role in protecting public health? Or is it just a handful of tobacco companies who see the new advertisement restrictions undercutting their bottom line?

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A group of doctors from around the world have came together to take a hard look at the relationship between nursing homes and profiteering, and the results reaffirm what many of us would have guessed: Nonprofit nursing homes provide better care than for-profit nursing homes.

Dr. Gordon Huyatt, the senior author of the studypublished in the British Medical Journal, stated “the reason patients' quality of care is inferior in for-profit nursing homes is that administrators must spend 10%-15% of revenues satisfying shareholders and paying taxes,” and as a result, “For-profit providers cut corners to ensure shareholders achieve their expected return on investment.”

Looking at 82 different statistical studies taken into account, 40 significantly favored nonprofit facilities. This means that in 40 of the 82 reports, it was obvious that patients received better care at the nonprofit facilities compared to for-profit facilities. On the flip side, only 3 of those studies favored for-profit facilities. The remaining 39 studies had inconsistent findings and were not counted either way. The study looked at four major factors in determining quality of care:

·        More or higher quality staffing;

·        Lower rates of pressure ulcers;

·        Less use of physical restraints; and

·        Fewer deficiencies cited by regulatory agencies.

These findings have significant implications for patients across America. Of the roughly 80,000 patients who have bedsores, 7,000 of those can be attributed to for-profit ownership. Additionally, the study went on to predict that if all the current for-profit nursing homes converted to nonprofit, 500,000 hours a DAY would become available to residents without additional cost.

There are many ways to interpret the study data, but the overall conclusion is clear: nonprofit nursing homes offer better care than for-profit ones. These sorts of studies may be very important in the health care reform debate, as many reformers push for an increase in “evidence-based medical treatment.”

Moving forward, if you or a loved one needs the care of a nursing home, look into whether that home is for-profit or not, because it clearly should be a factor to consider.

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Each year, many people in the United States are injured by defective foreign products imported into the United States. Loopholes in the law give foreign manufacturers ways of delaying lawsuits against them in the United States – but that may be about to change. Currently, when a foreign manufacturer’s product injures someone in the U.S. because of a defect, and the victim files suit against that manufacturer, serving the foreign defendant can take months or even years. As just one example, the recent Chinese-made drywall fiasco is faced with this sort of issue. Foreign manufacturers often seek to avoid judicial consideration of their actions by asserting that United States courts lack personal jurisdiction over their companies.  New legislation, however, seeks to make it easier for plaintiffs to establish service and get the lawsuit moving.

In many cases today, serving process on foreign defendants is complicated and time consuming, thanks to international law ratified in the 1960s. Plaintiffs must translate the papers into the manufacturer’s native language, sent to a “central authority” (someone appointed by that country), then serviced per the laws of the country. This can cause huge delays, from a few months to over a year.  Newly proposed legislation sponsored in early August by Senators Sheldon Whitehouse, (D-RI), Jeff Sessions, (R-Ala), and Richard Durbin, (D-Ill) called the Foreign Manufacturers Legal Accountability Act of 2009 addresses this problem with a two-pronged solution:

1.       Foreign manufacturers will be required to have an “agent” in at least one state, which is designated to accept service on the company’s behalf.

2.       Foreign companies consent to state or federal jurisdiction where their registered agent is located upon receiving service.

Obviously, this bill will not affect whether the manufacturer is liability for an injury or make the legal burdens on foreign manufacturers any greater than those imposed on domestic manufacturers. It simply makes service of process work as though the manufacturer were American.  

Despite bipartisan support, though, the bill has not passed.  But it is important that this important legislation get passed to finally end the loopholes which have allowed foreign manufacturers to delay lawsuits.  Foreign companies that import products into the U.S. should not be able to avoid liability simply because of difficulties relating to serving process upon the company.

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Recently disclosed court documents reveal that Wyeth, the pharmaceutical giant behind hormone replacement medications  Premarin and Prempro,has played a “major role” in 26 scientific articles published backing the medications. The articles are being criticized as over-emphasizing the benefits of hormone replacement therapy and downplaying the known risks. Wyeth solicited and paid surrogate non-medical authors to draft the articles and then paid doctors, who were “consensus builders” within the medical community, to sign off as authors in order to create the illusion of a positive general consensus among doctors that the therapy was safe and effective. And for a time, this “ghostwriting” worked. Sales of Wyeth’s HRT drugs soared to $2 billion in 2001.

But, in 2002, a huge ($700 million, 8 year) U.S. government study (WHI) stopped early when researchers found menopausal patients faced a big increased risk for invasive breast cancer, heart disease, and stroke while on HRT medication.  Multiple follow-up studies have been published including one from February of 2009 in The New England Journal of Medicine that support the conclusion that the decline in U.S. breast cancer rates is largely related to the decline in HRT use.   Sales have plummeted for HRT medication in light of recent media reports, and prescriptions are down from nearly 70 million in 2001 to less than 15 million in 2008.

Wyeth claims that the practice of hiring surrogate authors who serve as “ghostwriters” and then having doctors sign off on these favorable articles is common practice and a matter of convenience, not deception. Wyeth also claims that the articles are scientifically accurate. Even if convenience is a valid consideration – and even if the numbers in the articles were accurate – that does not mean that the articles were not written in a way favorable to Wyeth (when in fact, they were). Nor did the articles disclose Wyeth’s funding of the article’s production. Effectively – whether or not Wyeth’s ghostwritten articles were truthful in what they did say is irrelevant because it was deceptive in what they did not say.

Our firm has been deeply involved with HRT litigation, and we currently are representing over 100 women injured by HRT medication. In May of 2010, our firm has the first HRT trial scheduled in the State of Florida against Wyeth.

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The Family Smoking Prevention and Tobacco Control Act passed easily in both the House and Senate and was signed into law on June 22 of this year. The bill creates greater restrictions on the sale of tobacco products, as well as the ingredients inside cigarettes. But most importantly, it gives the FDA much greater power in regulating tobacco products. Most recently, the FDA is putting together a 12 person panel to advise the FDA on overseeing the industry.

With the bill’s passage, tobacco product manufacturers must now disclose all ingredients in its products, the form and delivery method of nicotine, and any research into the health, toxicological, behavioral, or physiologic effects of tobacco products to the FDA. They must also notify the FDA of any future changes to any of the ingredients or its effects. Additionally, new tobacco products must be reviewed by the FDA before they can go onto the market, and companies are banned from promoting products as lower-risk alternatives without FDA certification that the product will likely improve public health (good luck with that one, Big Tobacco).

How will we see this bill’s effect? For starters, the new oversight committee is funded wholly by fees assessed on tobacco companies and traders. This will in turn raise the cost of tobacco products, although not considerably so. Also, the bill requires the warning labels on packaging be more prominent. And finally, tobacco sponsorships of sporting, athletic and entertainment events using tobacco brand names and logos have been banned.

All of this movement toward more regulation of Big Tobacco is important to everyone, smoker or non-smoker, in light of the American Cancer Society report issued just this past week which projects 6 million deaths worldwide next year from the use of tobacco. These deaths will result from cancer, emphysema, heart disease and a whole host of other diseases and illnesses. Additionally, ACS estimates that tobacco use costs the global economy $500 BILLION a year in direct medical expenses, lost productivity and environmental harm.

Maybe this bill takes us one step forward to ensuring more responsible marketing of tobacco products after decades of misleading advertising and other unethical practices by Big Tobacco.

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Fox 13 Tampa Bay recently investigated a suspicious alleged bonus system in place at Brooksville Regional Hospital.  According to the allegations, 47 year-old Dave Roberts arrived at the ER after injuring his back and was in obvious pain, was unable to walk, and had lost control of his bladder.   The ER doctor chose only to administer two shots (presumably for pain) and ordered an X-ray. Roberts was then sent home. Three days later (the next business day), Mr. Roberts went to a specialist who immediately recognized the severity of the spinal injury and emergency surgery was performed. Unfortunately, Mr. Roberts suffered severe, permanent injury, which according to the lawsuit, was a direct result of Brooksville Regional’s hurry to get Roberts out the door.

It has been uncovered that Brooksville Regional gave a financial incentive to ER physicians for moving patients quickly through the ER.   Allegations suggest that ER doctors were offered a quarterly bonus if the average length of stay for a patient in the ER was less than two hours. The hospital is likely using these incentives to decrease the waiting times of patients in the ER (a desire fueled in part because ER wait time is a hot advertising trend) – which by itself is a good intention. Unfortunately some hospitals, such as Brooksville Regional, appear to have decided to rush ER visits instead of adequately staffing their emergency room department.

This bonus system clearly causes a conflict of interest between the doctor’s fiduciary duty of care and the Hospital’s interest in profit and reputation. Bonuses are common in the industry, but a bonus which directly contradicts the ability for a healthcare professional to provide adequate care is unacceptable. And for patients like Dave Roberts, it can ruin lives.

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