The Wall Street Journal (3/30, Loftus) reports that the US Patent and Trademark Office decided to uphold claims in the patent for Plavix [clopidogrel] after generic drug maker Apotex argued that research conducted before the patent was issued renders it invalid. Meanwhile, in a separate antitrust case, a judge dismissed claims filed by Kroger Inc. that retail pharmacies did not have access to generic versions of Plavix while drug makers Sanofi-Aventis SA and Bristol-Myers Squibb Co. attempted to settle patent litigation.

The New York Times (3/30, B6, Pollack) reports, “Cephalon said on Monday that the Food and Drug Administration had declined to approve use of its alertness drug, Nuvigil [armodafinil], to treat jet lag.” The drug is currently “approved to treat the excessive sleeping associated with narcolepsy, sleep apnea, and shift work.”

Bloomberg News (3/30, Larkin, Tirrell) reports that the agency “asked for more information about data used in the company’s effort to win an expanded use of Nuvigil tablets.” The drug initially received “an expedited six-month evaluation for jet lag as part of a priority review program for novel medicines.” But, “the agency delayed its decision by three months in December to give it more time to consider the submission…said” the company.

“In its complete response letter to Cephalon’s application for the additional approval, the FDA expressed concerns about the ‘robustness’ of the subjective assessments reported by patients taking the drug,” the Philadelphia Business Journal (3/30, George) reports. Reuters (3/30) also covers the story.

The Wall Street Journal (3/30, Rockoff) reports that Boston Scientific Corp.’s recent recall of its implantable heart defibrillators is under investigation by the Department of Justice and the Securities and Exchange Commission. The company halted sales of the defibrillators and recalled unsold devices after failing to seek approval for two manufacturing changes. Now, investigators have requested company documents about Boston Scientific’s discovery that the FDA had not approved the changes, as well as any reports of injuries from the devices.

        Boston Scientific awaits FDA review to resume shipments. The Minneapolis/St. Paul Business Journal (3/30) reports, “Federal regulators won’t expedite their review of paperwork Boston Scientific Corp. needs approved before it can resume shipping heart defibrillators to customers, the company said.” The company halted shipments “after it failed to notify” the FDA “of changes the company made to its manufacturing processes.” The agency “hasn’t agreed to make a decision any faster than” 30 days, “CEO Ray Elliot said.”

The Chicago Tribune /McClatchy (3/30, Hall) reports, “The Guttmacher Institute, a nonprofit that’s aligned with Planned Parenthood but nevertheless respected for its data on reproductive issues, reported Tuesday that the US teen pregnancy rate had risen by three percent from 2005 to 2006, the latest year for which figures are available.” This represents a rise “after 15 years of decline,” which the group attributes to “heightened federal funding of abstinence-only sex education — such programs reached a level of $176 million annually in the Bush administration — combined with a drop in contraceptive use among teens.”

The AP (3/30) reports, “GlaxoSmithKline PLC said Monday it is launching a program in the US to provide free vaccines to adults who don’t have health insurance.” The vaccines will include “shots for hepatitis A and B, tetanus, diphtheria and whooping cough,” and its cervical cancer vaccine Cervarix “also will be included for women between the ages of 19 and 25.” The GSK Vaccine Access program “is open to adults ages 19 and up whose income totals no more than $27,075 for a single person or $36,425 for a couple.”

The Milwaukee Journal Sentinel (3/14, Fauber) reported, “For years, drug companies sought out influential university doctors with impressive credentials to bring their message to other doctors and persuade them to write prescriptions for their products.” But as “the practice of doing promotional speaking for drug companies has come under fire in recent years,” more “medical schools…have developed conflict-of-interest policies that ban such talks.” Companies have, therefore, “been forced to back away from that approach,” turning to private physicians instead, who are not regulated by conflict-of-interest policies. As a result, US Sen. Herb Kohl (D-WI) “has co-introduced legislation requiring companies to release payments to doctors to highlight conflicts of interest for the public.”

Today’s Medical News From Newspapers, TV, Radio and the Journals  Monday, March 15, 2010

The AP (3/13, Perrone) reported that the FDA “is adding its strongest warning to the label for Plavix [clopidogrel bisulfate], cautioning that some patients do not respond to the blockbuster blood thinner.” According to the Los Angeles Times (3/12, Maugh) “Booster Shots” blog, the “warning indicates that the drug is dangerous only in the sense that it doesn’t work in” certain “patients and thus may leave them unprotected against heart attacks and strokes.”

        Specifically, some patients have a difference in a liver enzyme known as CYP2C19, which helps to convert Plavix to a form that the body can use, Dow Jones Newswire (3/12, Dooren) reported. Notably, FDA officials said CYP2C19 tests typically cost less than $500.

        Robert Temple, deputy director for clinical science at the FDA’s Center for Drug Evaluation and Research, said, “What there hasn’t been is a clear test of whether you can take people who are poor metabolizers, double their dose and do just as well,” according to Bloomberg News (3/12, Peterson, Larkin).

Bill protects ER against lawsuits

By Jim Saunders
3/4/2010 © Health News Florida

Reopening a political battle about medical malpractice, Florida senators are considering a bill that would limit the liability of hospitals, doctors and other workers for emergency-room errors.

The Senate Health Regulation Committee voted 5-2 this morning to approve the bill, which is sponsored by Sen. John Thrasher — an influential figure who also doubles as chairman of the Florida Republican Party — and is backed by groups such as the Florida Medical Association and Florida Hospital Association. 

The bill would extend what is known as “sovereign immunity” to hospital emergency rooms. Sovereign immunity, which normally applies to government agencies, restricts payouts to injured people or their families to $100,000 or $200,000, depending on the circumstances.

Thrasher, a St. Augustine Republican, said he is concerned that hospitals have difficulty getting physicians in high-risk specialties, such as neurosurgery and orthopedic surgery, to work in emergency rooms. He said lawsuit protections would help.

“We need to have access to these folks,” Thrasher said.

But limiting medical-malpractice lawsuits has long been a divisive issue in the Capitol, with trial attorneys already vowing to fight Thrasher’s bill.

Republican Sen. Durell Peaden, a Crestview physician who is a top lawmaker on health issues, also said he has qualms about the proposal to limit damages.

“Mistakes are made. You can’t totally disregard what happens,” said Peaden, who does not serve on the Health Regulation Committee but is the Senate’s health-budget chairman. “You’ve got to be fair to everybody on that issue.”

Lawmakers filed similar proposals to extend sovereign immunity to emergency rooms the past three years, but none of the bills passed committees. The issue could gain momentum this year, however, because of the backing of Thrasher — who won election to the Senate in 2009 after a nasty campaign that included attack ads financed by trial lawyers.

The debate also comes as congressional Republicans call for including medical-malpractice limits in a federal health-reform bill.

The Legislature had a full-blown debate about medical malpractice in 2003 and passed a law that included some liability protections for emergency-room doctors. As an example, the law placed limits of $150,000 or $300,000, depending on the circumstances, on what are known as “non-economic damages” that compensate victims for pain and suffering.

Also, public hospitals already have sovereign-immunity protections in lawsuits.

But Thrasher’s bill would go much further, extending the sovereign-immunity limits to emergency rooms at all hospitals that provide emergency care. Along with doctors and hospitals, the bill would extend the limits to workers such as paramedics and nurses, Pensacola medical-malpractice attorney Marcus Michles said.

Michles agreed that getting specialists, such as neurosurgeons and orthopedic surgeons, to work in emergency rooms is a problem. But he disputed the contention that granting sovereign immunity would attract them.

He said doctors in the past needed hospital privileges and, as a result, would be on call for emergencies. But he said they now can operate at surgical centers without the inconveniece of getting called to the ER.

“Twenty years ago, there was no such thing as an outpatient surgery center,” said Michles, who is chairman of the medical-malpractice committee of the Florida Justice Association, a statewide trial lawyers group.

A report issued last year by the state Office of Insurance Regulation indicated emergency rooms are the third most-frequent source of medical-malpractice lawsuits. The report examined malpractice claims closed in 2008 and found 436 that stemmed from emergency rooms — trailing hospital-inpatient care and physicians’ offices.

Sovereign immunity is designed to shield government agencies from expensive lawsuits. By extending it to emergency rooms, lawmakers effectively would give the same liability limits — $100,000 per claim or $200,000 if there are multiple claims from an incident — to medical providers.

Thrasher, a former general counsel of the Florida Medical Association, said such limits also could help hold down health-care costs. He said emergency-room doctors take extra precautions and practice “defensive medicine” because of the threat of lawsuits, unnecessarily increasing costs.

“That cost is borne by all of us,” said Tallahassee physician Craig Butler, who represented the Florida Orthopaedic Society at this morning’s meeting.

But Senate Minority Leader Al Lawson, a Tallahassee Democrat who voted against the bill, questioned the need to extend sovereign immunity to emergency-room workers beyond physicians. He called the measure “just too broad.”

Capital Bureau Chief Jim Saunders can be reached at 850-228-0963 or by e-mail at jim.saunders@healthnewsflorida.org. 

Today’s Medical News From Newspapers, TV, Radio and the Journals            Thursday, March 4, 2010

Leading the News

New guidelines say physicians should educate men on risks, benefits of PSA testing.

ABC World News (3/3, story 6, 2:00, Besser) reported that “there’s a big change in store” for prostate cancer screening. “Since1997, the American Cancer Society (ACS)…hasn’t routinely recommended the PSA test, but most doctors have done it. Now they’re saying you need to have a conversation between you and your doctor before that test is done.”

        The Los Angeles Times (3/4, Maugh) reports, “New guidelines…issued Wednesday emphasize that physicians should better educate men about both the risks and benefits of using the PSA test for screening.” The group “also urged greater use of education specialists, pamphlets, videos, and other materials.”

        The AP (3/3, Stobbe) reported that the ACS “wants doctors to talk to men and give them plenty of information before they have a PSA test to make sure they understand its limits.” The new guidelines follow recent findings that the “PSA test may lead to unnecessary treatment for many men,” because “the test can’t clearly indicate whether a cancer is aggressive or harmless.”

        PSA blood tests can “lead to false readings that require additional tests and biopsies…said” lead author Andrew Wolf, a physician at the University of Virginia, Bloomberg News (3/4, Randall) reports. “If patients do choose to be screened with PSA blood tests, those with low levels can safely be screened every other year instead of every year as suggested previously, according to the new recommendations.”

        The Houston Chronicle (3/4, Ackerman) reports that “the guidelines also urge doctors to…make the digital rectal exam an option rather than using it as a standard screening tool” and to “base the frequency of PSA testing on previous scores.” And, although the ACS does not “call for eliminating mass screening events,” the group recommends including “high-quality information upfront of screening’s potential risks.”

        CNN (3/4, Falco), MedPage Today (3/3, Bankhead), Reuters (3/4, Steenhuysen), HealthDay (3/3, Gardner), and Medscape (3/3, Mulcahy) also covered the story.

        Sanofi drug may boost prostate cancer survival. The New York Times (3/4, B10, Pollack) reports, “A new drug being developed by Sanofi-Aventis extended the lives of men with advanced prostate cancer in a clinical trial and could become a new last-ditch treatment,” according to research presented at the Genitourinary Cancers Symposium. Sanofi intends “to complete its application to the Food and Drug Administration for approval of” the new drug, cabazitaxel, “in the first half of this year.”

        Bloomberg News (3/4, Randall) reports, “Cabazitaxel is the first drug shown to break down tumors and prolong life after patients have been treated with Paris- based Sanofi’s Taxotere [docetaxel], a standard chemotherapy for prostate cancer, according to…the study’s lead author” Oliver Sartor, the Piltz Professor for Cancer Research at Tulane Cancer Center. He added that “progression-free survival was better, response rate was better, and virtually every subgroup of patients did better.”

        The New Orleans Times-Picayune (3/4, Pope) reports that the study showed an “increase of nearly 19 percent” in median survival time with cabazitaxel compared to mitoxantrone. Although cabazitaxel provides an “advantage of less than three months,” Dr. Nicholas Vogelzang, of the Comprehensive Cancer Centers of Nevada, who sits on the cancer-communications committee of the American Society of Clinical Oncology, noted that “advances in cancer therapy have always been incremental.”

        WebMD (3/3, Laino) reported that Vogelzang also said that men with early stage prostate cancer may see greater benefits from the drug. Reuters (3/4), MedPage Today (3/3, Phend), and the AP (3/4, Marchione) also covered the story.

        Dendreon says provenge boosts survival in patients with prostate cancer. Dow Jones Newswire (3/4, Shwiff) reports that Dendreon Corp. said that a Phase III study of its prostate cancer treatment Provenge (sipuleucel-T) showed that the drug boosted overall survival by 40% after three years compared to placebo. The company had previously reported a 38% increase in survival after 34 months. Dendreon is expected to present its data at the American Society of Clinical Oncology meeting Friday.

Pharma & Device Update

BPH may be best treated with combination of drugs.

The Los Angeles Times (3/3, Maugh) “Booster Shots” blog reported, “A combination of drugs is better than either one alone for treating benign prostatic hyperplasia or BPH.” After randomizing some 4,800 patients to either tamsulosin alone, dutasteride alone, or “a combination of the two drugs,” researchers at the University of Texas Southwestern Medical Center “found that patients taking the combination were 67% less likely to have acute urinary retention and 70% less likely to require surgery than those taking tamsulosin alone.” According to a study in European Urology, “patients taking the combination also reported fewer side effects and were less likely to drop out of the study.”

Reuters (3/3) and the Wall Street Journal (3/3, Becker) also covered the story.
 

Medical-Legal Landscape

Survey indicates growing incidence of medical identity theft.

McClatchy (3/4, Yip) reports, “The number of ID fraud victims jumped 12 percent in 2009, but consumers are becoming more educated and are filing more reports with law enforcement, according to Javelin Strategy & Research.” Experts “said the increase may be due to the economic downturn, when fraud rises historically.” Notably, “a budding area is medical ID theft, in which thieves use your personal and health insurance information to obtain medical treatment or drugs. Javelin’s survey found that the theft of medical records to commit ID fraud accounted for 7 percent of all instances of ID theft in 2009, up from 3 percent in 2008.”

In a front-page story, the New York Times (2/20, A1, Harris) reported, “Hundreds of people taking Avandia [rosiglitazone], a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports.” A Senate Finance Committee review cites internal FDA documents that highlight a dispute among regulators that “has been brewing for years but has been brought to a head by disagreement over a new clinical trial.”

        The Wall Street Journal (2/22, Mundy) reports that the Senate committee concluded that Glaxo was aware of the risks, but minimized the issue and attempted to suppress concerned physicians. The FDA’s documents also indicate that agency scientists said the drug should be pulled from the market in 2008, but FDA chiefs rejected the recommendations. Now, agency commissioner Margaret Hamburg is expected to meet “with FDA scientists and outside experts to gain a full understanding…of all of the data and issues involved,” a spokeswoman said.

        The AP (2/21, Ortutay) reported that the Senate committee is asking the FDA “why it allowed a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007.” Glaxo agreed to an FDA request for “a six-year study between its drug and” the Pfizer diabetes drug Actos [pioglitazone] “to give a definitive picture of Avandia’s safety.”

        But, the FDA’s internal documents showed that “safety officers…said that a medical trial comparing Avandia with Actos that was being planned would be ‘unethical and exploitive’ because it would expose patients to unwarranted risks,” Bloomberg News (2/21, Waters) reported. Sens. Max Baucus (D-MT) and Charles Grassley (R-IA) sent a letter to Hamburg “asking what steps the agency was taking to protect patients in the…trial and demanded a response to their concerns by March 4.”

        CNN (2/21) reported, “The Senate committee investigation stems from concerns that Avandia and other high-profile drugs put ‘public safety at risk because the FDA has been too cozy with drugmakers and has been regularly outmaneuvered by companies that have a financial interest in downplaying or under-exploring potential safety risks,’ the report states.” HealthDay (2/20, Mundell) and Reuters (2/21, Richwine) also cover the story.