Tampa Bay Personal Injury Lawyer - FDA

New Change to HIPAA Protects Patient’s Genetic Information

C. Todd Alley — Tue, 13 Oct 2009 09:24:56 GMT

On October 1^st, the U.S. Department of Health and Human Services (HHS) issued new interim rules protecting patient’s genetic information from being used against them. The new rules come as the department interprets and implements the Genetic Information Nondiscrimination Act of 2008 (GINA), and serve to amend the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule.

The new rules also define genetic information, genetic services, genetic testing, and related terms and phrases. Genetic information is defined as "information about the individual's genetic tests or the genetic tests of family members… [and] family medical history." This definition also clarifies that "genetic information" does not cover information about an individual's sex or age.

Under the new rule, group health plans and issuers in the group market cannot:

Increase premiums for the group based on the results of one enrollee’s genetic information;
Deny enrollment;
Impose pre-existing condition exclusions; or
Do other forms of underwriting based on genetic information.

In the individual health insurance market, GINA similarly prohibits issuers from using genetic information to deny coverage, raise premiums, or impose pre-existing condition exclusions. Additionally, insurance companies are prohibited from asking individuals or family members to undergo a genetic test. A violation of any of the above prohibitions can lead to fines from $100 to up to $50,000 per offense.

HHS Secretary Kathleen Sabelius supported the new rule, saying “consumer confidence in genetic testing can now grow and help researchers get a better handle on the genetic basis of diseases.” This comes after stories of patients too afraid of having genetic testing done, for fear of becoming unable to obtain insurance.

Sebelius added, “Genetic testing will encourage the early diagnosis and treatment of certain diseases while allowing scientists to develop new medicines, treatments, and therapies.”

Some insurance industry representatives don’t see GINA as necessary. “It’s an anecdotal fear,” said Mohit M. Ghose, a spokesman for America’s Health Insurance Plans, whose members provide benefits for 200 million Americans. Nonetheless, the fear can compromise the health of patients too afraid of losing health insurance by undergoing genetic testing. GINA and the new interim rule looks to alleviate the patients’ fears, and doctors can now more efficiently diagnose and treat certain diseases early.

The new interim rule is open to public comment for 60 days. The rule will then become final, barring any setback.

Originally posted at InjuryBoard by C. Todd Alley

Tobacco Makers Sue U.S. over Free Speech

C. Todd Alley — Tue, 29 Sep 2009 08:37:43 GMT

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?

Originally posted at InjuryBoard by C. Todd Alley

Tobacco Control Act and What it Means for Tobacco Users

Jim Clark — Mon, 31 Aug 2009 10:34:40 GMT

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.

Hopefully 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.

Originally posted at InjuryBoard by Jim Clark

Xenical/Alli Under FDA Investigation After Patient Complaints

C. Todd Alley — Thu, 27 Aug 2009 14:07:50 GMT

The FDA has begun investigating a potential link between liver damage and Orlistat (obesity drugs marketed as Xenical and Alli). On Monday, the FDA issued an Early Communication report to alert consumers and medical providers about a potential link between Orlistat and liver damage, particularly weakness or fatigue, fever, jaundice or brown urine.

Xenical is a prescription weight-loss drug marketed by Roche Applied Science. Alli is the popular over-the-counter (OTC) version of Xenical, marketed by GlaxoSmithKline, and is the first OTC weight loss pill to be approved by the FDA. These two drugs work by preventing the intestines from absorbing fatty acids. As a result, fats are not digested and the patient’s bowel movements are disrupted, leading to gas with oily discharge, increased bowel movements, and inability to control bowel movements. These side effects are amplified after eating meals containing large amounts of fat. Effectively, both these drugs work by forcing the patient to switch to a low-fat diet and trim fats, or face the uncomfortable and embarrassing consequences.

At this point, it’s too early to conclusively link Alli or Xenical to liver damage or disease, but the FDA has found enough merit behind these complaints to investigate further. The next step will be to wait for the final FDA investigational report and recommendations. If you or a loved one are taking Xenical or Alli, and have experienced any of the liver-related side effects mentioned, you should report side effects to your medical provider and to the FDA's MedWatch Adverse Event Reporting program.

Originally posted at InjuryBoard by C. Todd Alley

FDA’s Top Medical Device Regulator Steps Down, Another Top Official Under Investigation

C. Todd Alley — Wed, 19 Aug 2009 20:58:49 GMT

As my colleague wrote about in April, the FDA has come under fire from internal dissent over questionable medical device approval. Earlier this month on August 11, Dr. Daniel G. Shultz, the FDA’s Director of the Center for Devices and Radiological Health, announced he is resigning after 15 years on the post. The move comes after a “mutual agreement” with newly appointed FDA Commissioner Margaret Hamburg.

The controversy about Dr. Schultz came to light two years ago when Senator Chuck Grassley (R – Iowa) held hearings over Dr. Schultz’s approval of a nerve stimulation device, an approval that came over the objections of several FDA doctors. Dr. Schultz defended his decision, stating it was based solely on sound scientific data, although critics say he favored the industry over patient health.

Then again in March of this year, Senator Grassley opened an investigation over Dr. Schultz’s approval of a knee-surgery device – Menaflex - manufactured by ReGen Biologics, Inc due to reports of the Wall Street Journal. Dr. Schultz took full control of the process, and again approved a device despite vocal objections by FDA reviewers and doctors. In addition to approving the device, the approval process was even put on the fast track approval route, allowing it to reach the market quicker than normal.

These controversial decisions are not all that will define Dr. Schultz – Dr. Hamburg praised him in a statement, saying he will leave behind a “strong legacy,” but his ethical decisions are in part what has plagued the FDA in recent years. It’s good to see the new commissioner may be taking the steps necessary to preserve the integrity of the FDA.

The departure of Dr. Schultz was made around the same time that the longtime head of the FDA’s Center for Drug Evaluation and Research, Dr. Janet Woodcock, came under investigation after a drug company accused her of having inappropriate close professional ties to a rival drug company. The Inspector General’s Office at the Department of Health and Human Services is now investigating these claims.

Originally posted at InjuryBoard by C. Todd Alley

Chantix - A Cure Worse Than the Disease?

C. Todd Alley — Tue, 21 Jul 2009 12:00:00 GMT

Chantix has become the leading prescription to help smokers kick the habit. Pfizer, Manufacturer of Chantix, has reported skyrocketing sales since its introduction in 2006. Sales totaled $101 million in 2006, $883 million in 2007, and $846 in 2008. It’s dominant in its market, with a reported 90% market share.

Chantix is unique because it not only reduces the urge to smoke, it actually blocks the brain’s nicotine receptors. This means if the smoker lapses and lights up, it won’t satisfy the nicotine craving. Chantix can be taken up to 12 weeks, by which time the smoker should have lost any urge to smoke. By design, Chantix users experience the similar symptoms of quitting smoking cold turkey. Many patients experience mood swings, depression, and even thoughts of suicide. Pfizer has stated these side effects are a result of nicotine withdrawal, and not the drug itself. Other’s believe there is a link to Chantix and the psychological side effects.

Since Chantix was approved just a little more than three years ago in May of 2006, considerable controversy has mounted. Within months of its approval, the FDA issued public warnings about the increasing likelihood of Chantix being associated with serious changes in patients' behavior including agitation, hostility, depression, suicidal thoughts, and reports of attempted and completed suicide. In many cases, the problems began shortly after starting the medication and ended when the mediation was stopped. In 2007, the FDA released an alert to doctors to look for unusual behavior. This came shortly after the musician Carter Albrect was shot and killed. Those close to him cited his use of Chantix and atypical behavior leading up to his death.

The FDA issued a Public Health Advisory on February 1, 2008, to alert patients, doctors, and caregivers to important new safety warnings on the drug label relating to suicidal behavior and several other neuropsychiatic symptoms. Also, in 2008, the FAA banned the use of Chantix by pilots and co-pilots, citing possible psychological side effects. Also in 2008, the Department of Veterans Affairs made headline news by issuing Chantix to soldiers with post-traumatic stress disorder. Earlier this year Health Canada (Canada’s Public Health Department) revised the warnings of Chantix after receiving over 800 reports of adverse psychological side effects. Most recently, the FDA has (finally) required Pfizer to place new warnings in the form of a Boxed Warning – the strongest warning possible – highlighting the risks concerning Chantix and a link to changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide. The FDA has instructed doctors to have their patients cease use immediately if they experience any of these side effects.

With hundreds of suicides reportedly linked to Chantix, and thousands more attempted suicides, Pfizer has gone far too long downplaying the psychological side effects as simply nicotine withdrawal.

Originally posted at InjuryBoard by C. Todd Alley

Reglan Adverse Events Events Jump Dramatically

Joe Saunders — Tue, 07 Jul 2009 11:08:37 GMT

The FDA is reporting that instances of adverse events have more than doubled from 2006-2008. The adverse events associated with Reglan involve a muscle disorder tardive dyskinesia. The increase precedes Reglan's black box warning. Since the reporting system is voluntary, the adverse events may be significantly higher than those reported.

Reglan and its generic equivalent metoclopramide were approved by the FDA for short term treatment for certain types of gastrointestinal disorders such as gastroesophageal reflux disease or diabetic gastroparesis. However, the drug's marketing campaign pushed for longer term usage, substantially increasing the drug company's profits.

It was until February 2009 that the FDA pushed for a black box warning for Reglan. The disorders associated with Reglan use include tardive dyskinesia, dystonia, and neuroleptic malignant syndrome. All three are neurological disorders that can cause serious side effects involving muscle movement, pain, rapid breathing, and elevated heart rate.

Originally posted at InjuryBoard by Joe Saunders

FDA Seeks to Limit Acetaminophen Products Tylenol, Excedrin

Joe Saunders — Wed, 01 Jul 2009 10:32:14 GMT

The FDA will seek to lower the dosages of such acetaminophen products as Tylenol and Excedrin, long been considered to cause liver damage. In its panel vote, the FDA recommended lowering the maximum single and daily doses of acetaminophen.

In a related move, the FDA panel voted to eliminate such narcotics as Vicodin and Percocet, which combine narcotics with acetominophen.

According to a St. Pete Times article on the subject, acetaminophen products are the leading cause of liver damage and overdoses send an approximate 56,000 patients to the emergency room.

According to one local doctor, the panel vote is a long time in coming. "Hopefully, this will bring awareness to the population that Tylenol isn't as safe as people think," said Bryon Petersen, an associate professor at the University of Florida who specializes in liver regeneration, repair and disease. "It is a very nasty drug if used improperly."

Originally posted at InjuryBoard by Joe Saunders

Medtronic Class I Recall of Kappa and Sigma Series Devices

C. Todd Alley — Mon, 22 Jun 2009 12:51:35 GMT

Medtronic, in conjunction with the FDA, has issued Class I recall – the most serious type of recall classification reserved for products whose continued use could lead to serious illness or death - of the following lines of pacemakers:

· Medtronic Kappa Series 600/700/900

· Medtronic Sigma Series 100/200/300

The recall has been issued because of a serious risk of operational failure. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. Pacemaker-dependent patients may experience serious injury or even death. Most of the pacemakers affected by this recall have been implanted in patients for five years or longer.

Alley, Clark & Greiwe has been involved with Medtronic litigation for years, and our attorneys have been directly involved with other Medtronic recalls (including Medtronic Sprint Fidelis Leads and Medtronic Implantable Cardioverter Defibrillators (ICD) devices). While it’s unfortunate that another model line has been recalled, it is not particularly surprising. Please contact our office and we will help you determine if a particular pacemaker is part of this recall.

Originally posted at InjuryBoard by C. Todd Alley

Bisphenol A (BPA) California Ban Prompts FDA to Reinvestigate

Don Greiwe — Thu, 18 Jun 2009 16:10:47 GMT

Bisphenol A, or BPA, is an organic compound used in the production of plastics around the world. BPA is found in plastics used in numerous industries. Some uses include children’s food and drink containers, water bottles, reusable food containers, CDs, DVDs, household electronic equipment, and much more. BPA has come under fire politically in the recent years, and an outright ban of its use in certain products across the nation may potentially be imminent. The FDA has recently agreed to revisit the safety issues concerning BPA at the urging of Democratic lawmakers.

The safety of BPA use has been in controversy for decades, but only recently have major reports began to study its effects on animals and humans. With an LD₅₀ of 3.25 gm/kg, BPA has a relatively low acute toxicity rating. What is a concern, though, is that even low doses of BPA can mimic the body’s own hormones, causing a disruption in hormone production. Because of this, chronic toxicity (danger posed by continual exposure of low doses of BPA) is potentially a serious health risk. Earlier this month the California Senate approved a bill that would limit the use of BPA, and outright ban its use in infant products, such as baby bottles. Retailers, including industry giant Wal-Mart, indicated it will no longer carry infant bottles made from BPA. Many companies now advertise their non-use of BPA and have even removed BPA-containing products from store shelves.

In 2008, FDA determined that the possibility of chronic toxicity did not pose a significant health risk to Americans. The problem with this report, though, is that it was based off two industry-funded studies by the American Plastics Council. According an Environment California study, the chemical industry has funded 12 studies relating to BPA, and all 12 studies concluded that BPA had no adverse effects. In a collection of 139 independent government funded reports relating to BPA, 128 (92%) found adverse effects of low-dose BPA.

Clearly, the FDA should base its regulation of BPA on an independent study. And thanks to recently appointed FDA Commissioner Margaret Hamburg, they will. The American Chemistry Council is opposed to any further research, obviously in an interest to protect the manufacturers currently utilizing BPA. ACC has stated previously that BPA in contact with food products “has been and continues to be recognized as safe by the U.S. Food and Drug Administration.” So, the ACC uses FDA in making its case to the public that it is a safe product, yet it is opposed to the FDA revisiting the issue again.

Ironically, ACC has called the FDA’s recent call for independent research a product of “pressure from vocal special interest groups.” You have to wonder if ACC is really worried about a ban of BPA-infused infant products, which most major retailers won’t carry anyway, or if it’s worried a greater health risk will be discovered in the new studies, results of which will be released later this year by the FDA’s acting chief scientist.

Originally posted at InjuryBoard by Don Greiwe