According to an article from the Associated Press, when Big Pharma has a job opening- the first place they look is the FDA.
The former stewards of public health are extremely valuable to drug companies, because of their crucial experience. But what is good for Big Pharma is not always good for America.
With the FDA coming under fire just about every week now and paychecks that pale in comparison to what the world's largest drug-makers can provide, some of the agency's top scientists are leaving for greener pastures.
The problem? The FDA is already stretched thin with the departure of many Baby-Boomers and increased competition for science graduates. Now that other top-level personnel are jumping ship to Big Pharma, the FDA is left with a leaner, less experienced and less-confident staff, and tasking them with keeping America safe. The scenario has been dubbed the "FDA brain drain."
Steve Brozak, an analyst with WBB Securities, told the AP, "What you have now is a big sucking sound of these staffers leaving FDA and going into the more lucrative side of the business or packing it in and retiring entirely. This cannot have any positive effect whatsoever."
This is leaving the leadership of the agency scrambling to find bodies to fill the vacancies.
Those left behind are less confident about putting new drugs onto the market in light of more recent fiascoes like tainted heparin and Vioxx. And the dwindling numbers also mean that increase of the much-needed food and drug manufactures inspections are little more than a hoop dream.
According to an article from Prevention Magazine, doctors often overlook women's stroke risk, leaving them more vulnerable to the life-threatening condition than men.
Today researchers are working hard to raise awareness of female risk factors for stroke, also called "brain attacks".
Dr. Lewis Morgenstern, MD, director of the stroke program at the University of Michigan Medical School, told Prevention, "We all learned in medical school that strokes and heart attacks are male problems. The reality is far different."
In fact, women aged 45-54 are twice as likely as their male counterparts to suffer a stroke. However, a woman's symptoms are usually diagnosed slower and treated less aggressively than a man's.
Don't allow you or your loved one to loss precious time because of this gender gap! The moments that pass between the stroke's onset to treatment could be the difference between life and death, or permanent impaired. Stoke misdiagnosis occurs everyday, but the more you know about the risk factors and symptoms of a stoke, the better prepared you will be to handle this emergency situation.
If you have any of these risk factors, talk to your doctor about taking steps to reduce your chance of having a stroke:
1. Having High Cholesterol 2. Being on Birth Control Pills Could Double Your Risk 3. Undergoing Hormone Replacement Therapy 4. Suffering from Sleep Apnea 5. Suffering Migraine Headaches with Aura 6. Having a Blood-Clotting Disorder
Look for these tell-tale stroke warning signs:
1. Sudden Numbness or Weakness in the Face, Arms, Legs or One Side of Your Body 2. Sudden Confusion, Trouble Speaking or Understanding 3. Sudden Difficulty Seeing Through One or Both Eyes 4. Sudden Dizziness, Disorientation or Difficultly Walking
If you or someone you know if suffering from these sudden on-set symptoms, seek medical attention immediately. The faster they receive treatment, the better their chances for recovery. We all know what we can do live healthier, safer lives- getting regular exercise, eating plenty of fish and veggies, avoiding smoking and excessive alcohol consumption and, of course, not smoking! However, making a change in lifestyle can be overwhelming and difficult. If you are having trouble, enlist your doctor's help and try to find a buddy that is ready to make the change with you- this isn't something you have to do on your own!
Pfizer's new smoking cessation drug, Chantix, has hit a few bumps in the road since it received FDA approval in May 2006. The drug's sales have been stumbling since this the FDA announced new label warnings were necessary due to increasing evidence that drug triggers changes in behavior and suicidal tendencies in some patients. Now, other potentially dangerous side effects are coming to light, but you wouldn't know it from their adorable television commercials.
On Wednesday, a study was released by the not-for-profit organization, the Institute on Safe Medication Practices. It blasted the drug for adverse reactions such as "serious accidents and falls, potentially lethal cardiac rhythm disturbances, severe skin reactions, acute myocardial infarction, seizures, abnormal muscle spasms/movements, visual disturbances, diabetes, sudden losses of consciousness, psychosis, aggression and suicide." The drug accounted for 988 reports of serious injuries in the 4th quarter of 2007, more than any other drug in that period. In fact, 35 other drugs made up all the remaining 100 reports for the quarter. The Institute recommended that the drug be banned in all settings "where a lapse in alertness or motor control could lead to massive, serious injury."
Hours after the ISMP's study was released, the Federal Aviation Administration announced they would ban the drug for all pilots and air traffic controllers. Yesterday, the agency that oversees the trucking and busing industries, the FMCSA, requested that medical examiners "not qualify anyone currently using this medication for commercial motor vehicle licenses."
The FDA has yet to announce any new action. Agency spokesperson, Susan Cruzan, said they would continue to focus on the drug's link with neuropsychiatric side effects. "The agency has chosen to focus its current safety reviews on issues relevant to psychiatric adverse events but will continue to review other ADEs [adverse drug events] over time," she told the press.
On Wednesday, drug-maker, Pfizer, minimized the information released in the ISMP's report, saying most of the events reported were "infrequent" or "rare." The company said the serious side effects are already listed on the drug's warning labels, and over 5.5 million Americans have used the drug. Granted, just because 20 million Americans used Vioxx, didn't make it safe. Prescriptions of Chantix were last month by over 23% on last year. And sales estimates on the drug have been cut by more than 20% this year, 42% next year and at least 50% the following year.
To learn more about prescription injuries, click here.
Actor Dennis Quaid testified before Congress yesterday about the terrifying ordeal that nearly killed his newborn twins last year. The infants were given an accidental overdose of the blood-thinning drug, Heparin (shortly thereafter, the drug made additional headlines when tainted batches from China killed dozens).
He and his wife are suing Baxter International, the maker of the drug, as they believe confusing labeling on the bottle caused the mix-up. They also argued that the drug should have been recalled after three other infants died, also of accidental overdoses. Baxter cited preemption in their motion to dismiss the Quaid's lawsuit.
Before Congress, he urged lawmakers to protect the rights of average citizens, saying " I believe that if preemption of lawsuits is allowed to prevail, it will basically make all of us, the public, uniformed and uncompensated lab rats."
Here's some video of Quaid talking preventive medical negligence-
The FDA, under the Bush Administration, has advocated the preemption of lawsuits. FDA Deputy Commissioner Randall Lutter said, "[The] FDA believes that the important decisions it makes about the safety, efficacy and labeling of medical products should not by second-guessed by state courts."
Rep. Henry Waxman, D-CA, disagreed, saying, "One of the most powerful incentives for safety - the threat of liability - would vanish."
A few years back, I starting hearing about "medical tourism." Its basically when folks travel to other countries such as Thailand and India for surgery or other types of medical care.
Now, I've heard arguments both for and against it; however, none so interesting as the insight provided this Texas orthopedic surgeon, which you could watch here.
He actually says that one reason patients shouldn't go overseas and pay a fraction of U.S. medical costs (50-80% less, even after travel expenses) because he questions, "Is there legal recourse for the patient?"
Did he really just say that? It seemed odd to me that a doctor practicing in a state that fought so hard to limit an injured patient's legal recourse, that this would really be a concern for him. Why would it worry him that patients be denied access to "frivolous" lawsuits, when its nearly impossible for injured patients to get justice in Texas? I guess he's using this argument because he doesn't want to loose his next patient to some foreign doctor.
Now, I am not arguing for or against medical tourism, as I certainly am no expert on the subject. I cannot tell you whether the benefits outweigh the risks. I can; however, tell you that there are good and bad doctors everywhere, even here. So matter what you are getting done, or where you are going for it, do your homework. Research your doctor, ask him/her about their success rate with your type of procedure, ask for your hospital's infection rate and always ask questions about things you don't understand or that make you feel uncomfortable.
For more information about how to protect yourself from medical errors, click here.
Last week, the Patient Safety Authority, an independent PA agency, announced the release of the 2007 Annual Report on safety in PA healthcare facilities. Read the full report here.
The statistics for this year's report showed an increase of 16,151 incidents over last year. This includes an 8% increase in Incidents (described as near misses and events that reached the patient but did not cause harm) and a 5% increase in Serious Events (adverse events with patient harm). This is a startling increase.
As a plaintiff's firm, we often see the devastating and destructive effects of negligent healthcare. Each year an estimated 100,000 people die from preventative medical errors. Often times, Big Medicine wants to put the blame of high healthcare costs on the lawyers, but the truth is their own negligence cost lives and money- billions of dollars each year.
Our firm has been representing victims of medical malpractice for decades. We've got the skills and expertise necessary to hold Big Medicine accountable.
This year's report showed errors affected women more often than men (54% of errors were against females). A whopping 63% of adverse drug events affected women.
Of the total 212,000 incident reports, 23% were errors related to a procedure, treatment or test; 22% were medication errors, 17% were patient falls, 15% were complications during procedures, treatments or tests; and the remaining 23% of incidents affected transfusions, adverse drug reactions, equipment failures and other/miscellaneous events.
For more information about the Patient Safety Authority, click here.
Back in 1996, when the Health Insurance and Portability and Accountability Act (HIPAA) was signed into law, the intention of the law (especially Title IV) was to protect a patient's right to privacy, reduce fraudulent activity, streamline data systems and improve the health insurance system overall.
For years prior to the law's passage, there was no federal standard for obtaining your medical records. Without the patient's knowledge, records were being given to insurance companies, sent to landfills or just flat-out lost. Alerted by highly publicized lapses in medical record confidentiality (a garbage truck crash that sent medical records flying all over the highways, a doctor selling a computer without deleting patient information from the hard drive, and the list went on and on), lawmakers decided a better system was needed. So the whole theory behind HIPAA regs are that your medical records are just that, yours, and they cannot be given to anyone without your approved consent. Furthermore, you should be able to access your own medical records, or appoint a designee to get them for you.
After much protest from health organizations over steep fines for non-compliance, confusing new rules and the high cost of getting an office HIPAA compliant; the law was turned on its head. Today, its patients, not the insurance companies or providers that are having a hard time obtaining medical records.
What started out as an altruistic bill aimed at improving the health care system for patients, has become the ultimate Big Medicine delay tactic. Now they feel they are the gatekeepers between you and your medical records, and getting through may not be as easy as you'd think. Just ask the people in this USA Today article.
They know all too well the sneaky methods employed by hospitals to keep you from finding out what really went on during your hospital stay, sometimes by what experts refer to as "wrecking" medical records. This process is when hospital staffers knowingly try to obscure the records by darkening, lightening, shrinking or distorting the photocopies or adding White Out to the parts of the records they wish to keep hidden. Records are also selectively chosen, and most hospitals give a "summary" of key events. Full records (especially the incriminating ones) often go unrevealed forever, or at least until well after the medical malpractice statue expires. Convenient, huh?
So what's a patient supposed to do? First thing you have to know- you have recourse. Although a lot of things have changed about HIPAA, one thing hasn't- steep fines for non-compliance. If you or a loved one is having difficulty obtaining medical records, arm yourself with knowledge. This aspect of HIPAA is monitored by the Health & Human Services' Office of Civil Rights (you can find your local branch here). These are the guys that you need to bring your concerns to, and they will assist with filing a complaint. Once you bring it the OCR's attention, it will be investigated, and appropriate action will be taken.
Remember, hospitals have 30 days to provide you with records that they house on-site, 60 days for those housed off-site, and if they cannot get them to you in that time frame, they need to notify you. Don't let them push you around, especially if you have time restrictions such as a running statue of limitations.
If all else fails, call the Department of Health. Although no private civil action can be brought against the hospitals for non-compliance, there are plenty of rules targeted at keeping them in line.
Want to play it safe? Make the effort to periodically collect your records with each doctor and pharmacy that you use. You will have to pay for the records, but having them at your disposal might just prove to be beneficial.
For more information on HIPAA and making a complaint, check out the HHS website, here.
In just a few minutes from now, lawmakers will examine whether or not FDA inspectors could have prevented contaminated heparin from reaching the U.S. market. Watch it live, here.
Yesterday, Chinese and U.S. officials battled over whether or not a containment in the drug caused severe allergic reactions that killed 81 Americans. Previous reports put the number of dead at 20. They also argued the source of the contamination, with China suggesting it occurred in the U.S. The contaminated drug has been discovered in 11 countries across the globe.
The House and Energy Sub-Committee will be grilling FDA Chairman, Andrew von Eschenbach, who is expected to discuss the agency's plan to open a Chinese office next month. Lawmakers will also hear from FDA advisers who are requesting an additional $375 million to repair its poorly staffed and underfunded inspection process. CNN reports that the Bush Administration has requested $54 million for the FDA in the 2009 fiscal budget, a number that is under fire from both Democrats and Republicans in Congress.
Describing the heparin contamination as a world-wide problem, Dr. Janet Woodcock told U.S. Officials that the FDA's Center for Drug Evaluation and Research has "now established a mechanism by which we think this contaminant could cause these adverse events." To read more about the on-going heparin saga, click here.
A medical malpractice lawsuit has been filed on behalf of a six-year-old Orange County, CA girl who suffered permanent brain damage after doctors wrongly declared her dead. The little girl, who was five years old at the time, fell into her backyard pool and was rushed to the hospital. Read more here.
The girl was treated, declared dead and her breathing tubes were removed. More than an hour later, police officers investigating the incident discovered that the girl was still alive, and alerted the medical staff. Doctors were able to revive the girl; however, she suffered permanent brain damage from lack of oxygen.
The girl's mother hopes a jury will award the family enough money to pay for care needed by their child, who now has special needs.
She told the San Francisco Chronicle that, "If she needs a piece of equipment, she shouldn't have to worry about how to get it or how she is going to get it. These things are not covered by insurance. We're not able to have it."
We've all heard about it, big insurance companies happily accepting premiums for years and years until a customer submits a large medical bill. Then, that person's medical records are reviewed and either because of an inadvertent or insignificant omission of information, their coverage is dropped. Now, the person is uninsurable, and probably lacking the capital necessary to properly treat their disease. Insurers defend these practices, saying protecting themselves from fraud keeps premiums low for everyone (and profits high for them).
Now, a California regulatory agency is reviewing the "recission" practices of five major insurers, WellPoint Inc.'s Anthem Blue Cross, UnitedHealth Group Inc.'s PacifiCare, Health Net Inc., the Kaiser Foundation Health Plan and Blue Shield of California. The state will be pouring through the companies' records over the past four years, and allowing independent arbitrators decide whether or not they acted in good faith. If it is determined that a policy was wrongly canceled, it will be immediately restored, and the insurer will be responsible to pay all medical bills incurred by the consumer over the time they were without insurance.
Today's announcement could mean the restoration of thousands insurance policies across the state. Read more here.
This isn't the first move California has made against insurance companies' policies. Last fall, the state fined Health Net $1 million for failing to disclose a link between employee bonuses and the cancellation of individual insurance policies. And on Wednesday of this week, Los Angeles City Attorney, Rocky Delgado, filed a $1 billion lawsuit against Anthem Blue, for their questionable practices. In another lawsuit against Health Net, the insurer was forced to pay nearly $9 million to a woman whose battle with breast cancer left her without coverage and facing mounting medical bills.
The Govenator has pledged his support in the fight against these harmful practices. In a released statement he said he would work with the legislature to "ensure this egregious practice is stopped." He went on to say, "It's outrageous that innocent patients have to live in fear of losing their health care coverage."
Two new reports in the Journal of the American Medical Association have raised concerns that Merck employed questionable ethics in pushing their dangerous drug, Vioxx, onto the market. You're shocked, I'm sure.
The reports were based on court documents discovered throughout the course of the 4.85 billion settlement involving 47,000 patients injured by the drug.
The first report alleges (read about it) that Merck was well-aware of the fact patients taking Vioxx in clinical trials were three times as likely to die as those taking placebo. Instead, Merck reported the drug was "well-tolerated," failing to report the findings of their study to the FDA and the public in a timely fashion. Vioxx was eventually withdrawn from the market in 2004. The second report (as described here) indicates that Merck used company-hired individuals to write their studies, then paid well-respected academic scientists to take credit for them. The Journal indicated that this is common, but questionable practice in today's medicine, and urged reform.
Merck denies the reports, saying they were "false and misleading." And they know all about false and misleading!
Proving once more that no tort reform is necessary in Pennsylvania, the Supreme Court of PA announced yesterday that medical malpractice cases are down 40.8% statewide, and down over 50% in Philadelphia County.
Med mal cases have been on a steady decline since 2003, when a rule change required a medical expert certify all malpractice cases to ensure that there was deviation from the standard of care. The rule change also required cases to be heard in the same county where the alleged harm occurred, which eliminated so-called "venue shopping."
In a release, Chief Justice Ronald D. Castille said, "The latest statistics provide additional evidence that the sharp drop in medical malpractice litigation, which began in 2003, was not a temporary correction, but a sustained response to the procedural rule changes adopted by the Supreme Court and the statutory changes enacted by the General Assembly." He went on to say that "Ongoing review and enhancements to our procedures will ensure that both plaintiffs and defendants can rely on an accessible court system where professional liability actions are impartially and promptly resolved."
Read the report released by the PA Supreme Court here.
On the heels of a highly publicized drug mix-up involving actor Dennis Quaid's newborn twins, preventable pediatric medical errors are once again in the news. Check out the story here.
The Joint Commission, a hospital accreditation agency, announced new guidelines to ensure quality of care for infants and toddlers. Just days earlier, the medical journal, Pediatrics, reported that one out of 15 pediatric patients experience an accidental overdose or some other type of adverse drug reaction. 7.3% is a much bigger number than previously estimated, and according to the Washington Post, it "underscores growing concerns about medical errors involving hospitalized children ."
Now, medical experts are calling on hospitals, doctors and parents to help prevent these dangerous medical errors. To learn more about the Commission's report and what you can do to keep your kids safe, click here.
The Pennsylvania Health Care Cost Containment Council (PHC4) released its annual report on Hospital-Acquired Infections in Pennsylvania. You can read it here.
The report reviewed 165 of the state's acute-care hospitals, and determined how well they prevented facility-acquired infections. The report showed a 60% increase of infections from 19,154 in 2005 to 30,237 cases in 2006.
Of the roughly 30,000 Pennsylvania patients that were sickened by hospital-acquired infections, almost 4,000 died. The most common and most fatal of the infections were of the urinary tract (UTI), usually caused by failing to sanitize and remove catheters. In addition to the pain and suffering caused to its patients, these preventable infections also took a chunk out of Pennsylvania's wallet. UTI's cost one state hospital roughly $450,000 per case. Another facility spent $1.25 million on care for each patient that developed pneumonia from a ventilator, and a third hospital shelled out $1.4 million per patient with multiple infections.
Many tort-reformers out there would like you to blame your healthcare cost increases on the verdicts and settlements received by those who have been injured or killed during their hospital stay. The truth of the matter is, jury awards are down, while preventable hospital errors and infections (and the costs associated with them) are on the rise.
According to a study by the Institute of Medicine (IOM), as many 100,000 Americans die each year from preventable medical errors. Healthgrades reported these errors cost the U.S. as much as $8.8 billion per year.
While I commend the state of Pennsylvania for blazing a trail of transparency with this report, and empowering citizens with potentially life-saving information, I urge Pennsylvania hospitals to do more to protect their patients. After all, the customer comes first.
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