FDA Revokes Approval of Avastin for Treatment of Breast Cancer

On November 18, 2011, the FDA revoked its approval of  Avastin (bevacizumab) for the treatment of metastatic breast cancer. According to FDA Commissioner Margaret Hamburg, MD, evidence shows that the risks associated with this medication outweigh the possible benefits. Although early studies were encouraging, follow-up studies fail to support these findings and clearly demonstrate the potentially life-threatening side effects of Avastin. These side effects include severe hypertension, hemorrhage, and perforations of the stomach, nose and intestines.

Avastin retains FDA approval for the treatment of colon, kidney, lung and brain cancer. Furthermore, doctors may continue to prescribe Avastin off-label for the treatment of breast cancer, and Medicare has stated it will continue to cover the cost of the medication.

Click here for the FDA Statement revoking approval

Teen Driving: Fatal Crashes and Older Teens

According to a recent study, strict driver education requirements have resulted in fewer fatal accidents involving teens. However, these encouraging statistics apply to 16 year old drivers; fatal accidents involving 18 year olds have actually increased. The study reveals that many teens are opting to postpone getting their license until they reach 18 in order to by pass the tough licensing laws and driver restrictions placed on younger teens. In addition to requiring  driver education courses, state driving laws usually require longer permit periods, restrict night time driving and regulate passengers for younger teens. 18 year olds are not subject to these laws and in many states they receive a driver’s license in a matter of weeks. The study suggests that lack of education and experience is partially responsible for the increase in fatal accidents among this age group.

Details of the study are available in the Abstract on the JAMA website, and the NPR Health Blog. For advise on teen driving safety, see the AAA Guide to Teen Driver Safety.

ShoulderFlex Massager Recall

 

The Food and Drug Administrations is warning people to stop using the ShoulderFlex Massager after reports of life threatening injuries.  The massager, distributed by King International, is being blamed for one death and one near strangulation.  According to the FDA warning, hair, clothing and jewelry can get caught in the rotating bar of the massager and lead to strangulation or other serious injuries. Consumers and health care providers are being urged to discontinue the use of this product. The FDA is also requesting that consumers separate the parts of the massager by removing the massage fingers and the power supply and discard them separately to prevent it from being reassembled.

On August 31, 2011, King International announced a recall of its ShoulderFlex Massager.  The press release notifying the public of the recall is available on the FDA website.

 

Table Saw Injuries

 

According to the National Consumer League (NCL), table saw injuries have risen to 40,000 per year, an increase of 10,000 over the past decade.  Approximately 10 percent of these injuries result in finger amputation. The NCL has been pushing the Consumer Product Safety Commission (CPSC) to pass improved safety standards to help prevent saw-related injuries.

According to Sally Greenburg, the Executive Director of the NCL, the tool industry is opposed to efforts to implement new safeguards.  Most table saws are equipped with plastic guards to prevent injury. However, these guards are simple to remove in order to make the tool easier to use.  The NCL is encouraging manufactures to adopt a new technology sold by a company called SawStop. “That technology uses sensors to detect the electrical impulse in a finger or other body part—distinguishing flesh from a piece of wood, for example—and drops the blade down in a fraction of a second below the saw to keep it from injuring the user.” (NCL June 2011 press release) The technology increases the cost of table saws by about $100. Other table saw manufacturers are reluctant to incorporate this technology because of the increased cost to the consumer.

The CPSC’s 2011 Operating Plan includes the preparation of a briefing package addressing proposed safety standards aimed at reducing the risk of table saw injuries.  (See page 31 of the 2011 Operating Plan)

 

Side Effects of Drug Crestor

 

Crestor, sometimes referred to as a “super statin”, is the strongest drug available for the treatment of high cholesterol. A condition called rhaddomyolysis is a possible side effect of most statins.  This occurs when muscle tissue breaks down and myoglobin is released into the bloodstream, sometimes resulting in kidney failure. Research suggests that the risk of developing rhaddomyolysis increases with higher doses of statins.  Studies also show that the following patients are at a greater risk for this condition: Asian-Americans, people taking immune suppressing drugs, and people with severe kidney disease. In 2005 the FDA issued a health advisory addressing both the risks and benefits associated with the use of Crestor.  The manufacturer was required to revise the prescription label to include all the possible risks and recommended doses for patients most susceptible to developing these serious side effects.

 

FDA Warning: Diabetes Drug Actos

 

The FDA has issued a warning that there may be an increased risk of bladder cancer for patients who use the drug Actos for prolonged periods of time. Patients exposed to higher cumulative doses of the drug also appear to be at an increased risk of bladder cancer. The warning comes after a 5 year study of Actos by the manufacturer. Notice about this risk will be added to the Warning and Precautions section of the prescription label.

The FDA warns that Actos should not be prescribed to patients who either have bladder cancer or have a family history of bladder cancer. Recent studies in France support these findings and use of the drug Actos has been suspended in France.

The complete Safety Announcement can be found on the FDA website.

Medical Malpractice: Breach of the Standard of Care

The fundamental issue in all medical malpractice cases is whether or not the health care provider breached the standard of care. According to Connecticut General Statute Sec. 52-184c, the plaintiff in a medical malpractice action must prove “by the preponderance of the evidence that the alleged actions of the health care provider represented a breach of the prevailing professional standard of care for that health care provider. The prevailing professional standard of care for a given health care provider shall be that level of care, skill and treatment which, in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar health care providers.” In other words, it is incumbent on the plaintiff to find a health care provider with training and experience in the same specialty or discipline who is qualified to establish the appropriate standard of care and is of the opinion that the defendant breached that standard.  Connecticut General Statute Sec. 52-190a mandates that a complaint for medical malpractice contain a certificate of good faith that “reasonable inquiry gave rise to a good faith belief that grounds exist for an action against each named defendant.”  The statute further requires the plaintiff to “obtain a written and signed opinion of a similar health care provider, as defined in section 52-184c, … that there appears to be evidence of medical negligence and includes a detailed basis for the formation of such opinion.” The three essential questions that arise in medical malpractice questions are: 1) What is the requisite standard of care, 2) did the health care provider deviate from that standard, and 3) was the injury caused by the deviation from the standard? Connecticut courts generally require the plaintiff to produce an expert witness who will testify to “both the standard of care to which the defendant is held and the breach of that standard.”  Vitone v. WaterburyHospital, 88 Conn. App. 347, 351 n. 5, 869 A.2d 672 (2005).

Medical Malpractice: Informed Consent

Informed consent pertains to the right of a patient to receive the information necessary to make an informed decision with regard to medical treatment or therapy. In the case of Canterbury v. Spence, 464 F.2d 772, 787 (D.C. Cir.), cert. denied, 409 U.S. 1064 (1972), the court specified the following elements which should be disclosed by a physcian: “1) the ‘nature’ of the procedure, 2) the ‘risks’ and ‘hazards’ of the procedure, 3) the ‘alternatives’ to the procedure, and 4) the anticipated ‘benefits’ of the procedure.”  The so called ‘lay standard of disclosure’ was followed by Connecticut in the case of Logan v. Greenwich Hospital Assoc., 191 Conn. 282, 293 (1982).  Connecticut courts continue to apply this doctrine of informed consent. In “’Logan v. Greenwich Hospital Assn. … we adopted a lay standard and stated that under the doctrine of informed consent, a physician is obligated to provide the patient with that information which a reasonable patient would have found material for making a decision whether to embark [on] a contemplated course of therapy. . . . We repeatedly have set forth the four elements that must be addressed in the physician’s disclosure to the patient in order to obtain valid informed consent… (1) the nature of the procedure; (2) the risks and hazards of the procedure; (3) the alternatives to the procedure; and (4) the anticipated benefits of the procedure.’”Levesque v. Bristol Hosp., 286 Conn. 234, 253 (2008).

 

Car Accidents: Uninsured Motorists Insurance

The medical costs for treating injuries sustained in a serious automobile accident frequently exceed the insurance coverage limits carried by most drivers. The law in Connecticut pertaining to uninsured and underinsured motorist coverage is found in Connecticut General Statute Sec. 38-336. The purpose of this statute is to provide protection in situations where motorists either do not have insurance or have inadequate coverage: “Each automobile liability insurance policy shall provide insurance, herein called uninsured and underinsured motorist coverage … with limits for bodily injury or death not less than those specified in subsection (a) of section 14-112, for the protection of persons insured thereunder who are legally entitled to recover damages from owners or operators of uninsured motor vehicles and underinsured motor vehicles and insured motor vehicles, the insurer of which becomes insolvent prior to payment of such damages, because of bodily injury, including death resulting therefrom …”  This type of coverage pays for injuries when someone is involved in an accident with a hit and run driver, or a driver whose policy limits are not high enough to cover the cost of the injuries. Uninsured motorist insurance also covers pedestrians or bicyclists who are struck by an automobile.