Leading News in Pharmacy

Pfizer agrees to $2.3 billion drug-marketing settlement.

The CBS Evening News (9/2, story 5, 0:15, Rodriguez) reported that on Wednesday the government "hit Pfizer, the world's largest drugmaker, with a record $2.3 billion in fines for violating federal drug marketing rules. Among other things, Pfizer was accused of promoting the pain medication Bextra [valdecoxib] for unapproved uses."

NBC Nightly News (9/2, story 6, 0:30, Williams) added that the penalties come from "admitting that the painkiller Bextra and 12 other drugs were promoted for what's known as off-label use, which the FDA says put public health at risk in the process."

ABC World News (9/2, story 2, 2:25, Gibson) reported that "Bextra became a blockbuster, bringing in $1.2 billion a year, as sales reps assured doctors it could be used not just for arthritis, but for any acute pain. The main whistleblower, a former company sales rep, said in a statement, 'at Pfizer, I was expected to increase profits at all costs, even when sales meant endangering lives. I couldn't do that.'" Meanwhile, "in exchange for hearing company sales pitches, doctors were paid up to $1,500 to attend meetings, and were treated to conferences at lush resorts, given air fare, hotels, meals, even massages."

The Washington Post (9/3, Johnson) reports, "Officials at the departments of Justice and Health and Human Services called the agreement with Pfizer and one of its subsidiaries a cautionary example of their strategy to team up with states to police errant healthcare businesses."

"The Justice Department described Wednesday's settlement as the largest in its history," according to the Los Angeles Times(9/3, Meyer). "The settlement reflects an emphasis by the Obama administration on holding US healthcare corporations accountable for their activities, especially in trying to market drugs to patients and doctors for uses that have not been approved, Justice Department officials and legal experts said."

The New York Times (9/3, Harris) adds, "Although the investigation began and largely ended during the Bush administration, top Obama administration officials held a news conference on Wednesday to celebrate the settlement, thank each other for resolving it and promise more crackdowns on health fraud."

Pfizer subsidiary Pharmacia & Upjohn "must pay a $105 million criminal fine" under the agreement, USA Today (9/3, Rubin) reports. "Pfizer "will pay a criminal fine of $1.195 billion" and "has agreed to pay $1 billion in civil damages and penalties to compensate federal healthcare programs for false claims submitted as a result of its marketing Bextra and the other [three] drugs for off-label use or at unapproved dosages." The three other drugs include "Geodon [ziprasidone], an antipsychotic; Zyvox [linezolid], an antibiotic; and Lyrica [pregabalin], an anti-epileptic drug."

The Wall Street Journal (9/3, B2, Rockoff, Kendall, subscription required) noted that the settlement is the third since 2002 in which Pfizer has promised to change its marketing practices. The AP (9/3, Barrett), the Washington Times (9/3, Conery), the Philadelphia Inquirer (9/2, Hill), the Dow Jones Newswire (9/3, Kendall), Reuters (9/3, Berkrot) and Bloomberg News (9/3, O'Reilly, Capaccio) also cover the story.

Regulatory

Jurors consider Merck's Fosamax case.

On the front page of its Business Day section , the New York Times (9/3, B1, Singer) reports, "Drug executives, product liability lawyers and Wall Street analysts are closely watching a jury trial in New York over medical problems associated with Fosamax, a drug" used "to offset the bone loss associated with menopause." The case "is the first of about 900 state and federal cases pending against Merck in which plaintiffs claim that taking Fosamax caused them to develop...osteonecrosis of the jaw." In the current case, the plaintiff, Shirley Boles, "alleges that taking Fosamax from 1997 to 2006 caused her jawbone tissue to die." Merck is currently "trying to complete a $41 billion merger with Schering-Plough," and "industry analysts are closely watching this first trial to gauge Merck's potential financial liability."

The Wall Street Journal (9/3, Bray, subscription required) reports that an attorney for Merck claims Boles' osteonecrosis occurred three years after she stopped taking the drug. Boles, therefore, cannot blame Fosamax for having caused the condition, the attorney contended. Merck is accused of misrepresenting "the drug's safety and" failing "to warn doctors and patients that it might hamper blood flow to the jaw," Bloomberg News (9/3, Weidlich, Fisk) reports. Plaintiffs also contend that Merck failed "to include an adequate warning about Fosamax's risks when the label was changed." Reuters (9/3, McCool) also covers the story.

FDA panel recommends approval for pralatrexate.

The AP (9/3) reports, "A spokeswoman for the Food and Drug Administration said the agency's panel of oncology experts voted 10-4 that [Allos Therapeutics'] drug pralatrexate [Folotyn] would likely benefit patients with T-Cell lymphoma." Allos "has asked the FDA to approve its drug for patients whose cancer reoccurs or has not responded to other drugs," and there are "currently no FDA approved treatments for the disease." The company's "studies of the drug showed 27 percent of patients with T-Cell lymphoma responded to treatment, with more than half responding for about three months." The FDA is expected to decide on the drug by Sept. 24.

Reuters (9/3, Heavey) adds that the FDA, which is reviewing the drug under an expedited process, also cautioned the panel that while the drug seems to have some active effect on T-Cell lymphoma, that effect alone may not be enough to merit approval.

Knopp receives FDA fast track designation for ALS drug.

The Pittsburgh Business Times (9/2) reported, "Knopp Neurosciences Inc. has received fast track designation from the Food & Drug Administration for development of a drug to treat amyotrophic lateral sclerosis, better known as Lou Gehrig's disease." The company "has completed the randomized, placebo-controlled part of its phase two studies of the drug in 102 ALS patients and anticipates starting third-phase studies in the United States and Europe next year." Those participating in the second phase of the study "were offered enrollment in an ongoing, 48-week safety trial, where all participants are receiving the highest dose tested of the Knopp drug, which is known as KNS-760704."

FDA extends review of Endo's Nebido by three months.

The AP (9/3) reports, "The Food and Drug Administration has extended a review of a testosterone drug candidate by three months, the product's maker, Endo Pharmaceuticals Holdings Inc., said Wednesday." The agency "extended its review period to Dec. 2," because it "needs more time to review the application and complete a risk evaluation and mitigation strategy." The drug, Nebido, "a long-acting testosterone undecanoate injection," is "intended to treat hypogonadism."

The agency "has not requested additional data" from Endo, the Philadelphia Business Journal (9/2, George) reported. Nebido is currently "approved in 86 countries worldwide." The drug "was discovered and developed by Bayer Schering Pharma," which "licensed the US rights to the product to Indevus Pharmaceuticals." Endo acquired Indevus "earlier this year." Reuters (9/3, Raj) also covers the story.

Health Coverage and Access

Obama to address joint session of Congress on healthcare reform.

The White House announced Wednesday that the President will deliver a speech to a joint session of Congress next Wednesday night on the issue of healthcare reform. The AP (9/2, Babington) reports that the speech opens "an urgent autumn push to gain control of the debate that has been slipping from his grasp under withering Republican-led attacks." The Administration's "scheduling of the speech next Wednesday night, just a day after lawmakers return from their August recess, underscores the determination of the White House to confront critics of Obama's overhaul proposals and to buck up supporters who have been thrown on the defensive." The timing "also suggests that top Democrats have all but given up hope for a bipartisan breakthrough." The Christian Science Monitor (9/3, Feldmann) reports that "at this point, talk of a bipartisan plan has evaporated. So, analysts say, what he needs to do is unite his own party, in both houses of Congress, and proceed from there."

The New York Times (9/3, A1, Pear, Calmes) reports on its front page that Administration officials said the President "would be more specific than he has been to date about what he wants included in the plan. Doing so amounts to an acknowledgment that the president's prior tactic of laying out broad principles and leaving Congress to fill in the details was no longer working and that Mr. Obama needed to become more personally involved in shaping the outcome." However, "the officials said Mr. Obama was unlikely to unveil a detailed legislative plan of his own," and "insisted" the President had not given up on a public option.

Health Business

Dainippon to buy Sepracor for $2.6 billion.

Bloomberg News (9/3, Matsuyama, Randall) reports, "Dainippon Sumitomo Pharma Co. will buy Sepracor Inc. for $2.6 billion, gaining a US sales force and experimental treatments in the world's biggest drug market." Sepracor "will become a wholly owned unit of Dainippon after the all-cash transaction is completed," according to statement from the companies. Bloomberg adds, "Sepracor has a sales force of 1,200 in the US and is researching drugs including treatments for asthma, allergic rhinitis and insomnia."

The Dow Jones Newswire (9/3, Shimamura) also notes that if the purchase goes through, "Dainippon would be able to open a sales channel in the US for its new schizophrenia drug [Lurasidone] currently in phase-3 clinical studies."

Abbott to develop diagnostic test for Pfizer drug.

The Chicago Tribune (9/3, Japsen) reports, "To tap the growth potential of personalized medicine, the diagnostic business of North Chicago-based Abbott Laboratories will work with Pfizer Inc. to develop a test to determine which patients will benefit from an experimental lung cancer drug being developed by" Pfizer. Abbott's "companion diagnostic test" will help to "'determine a patient's genetic status and will be used in patient selection for future clinical trials' of Pfizer's PF-02341066, a cancer therapy targeting non-small-cell lung cancer." Abbott did not "disclose potential sales for such a companion test."

Research

Study indicates experimental drug may be promising against basal cell carcinoma.

The Wall Street Journal (9/3, Winslow, subscription required) reports that, according to a study published online Sept. 2 in the New England Journal of Medicine, Genentech's experimental drug GDC-0449 appeared to shrink tumors in 18 of 33 patients in the advanced stages of basal cell carcinoma. The drug also temporarily and dramatically helped a 26-year-old man suffering from medulloblastoma, a brain cancer.

HealthDay (9/2, Gardner) pointed out that GDC-0449 "switches off the so-called 'Hedgehog' pathway." HealthDay noted that "the Hedgehog pathway has been implicated in other cancers, notably colon cancer and ovarian cancer, albeit in a different way." Therefore, investigators "are going forward to look at the potential of...GDC-0449 to treat these types of cancers as a one-drug regimen, and in combination with other drugs for other solid tumor malignancies," explained study author Charles M. Rudin, MD, PhD, of Johns Hopkins University. In an accompanying editorial, Andrzej Dlugosz, MD, professor, department of dermatology, University of Michigan Medical School, "noted that finding a compound that might control the Hedgehog pathway could have far-reaching implications."

WebMD (9/2, DeNoon), MedPage Today (9/2, Bankhead), Medscape (9/2, Chustecka), AFP (9/3), Reuters (9/3, Steenhuysen), and the Arizona Republic (9/3, Alltucker) also cover the story.

Research suggests perioperative statin therapy may be linked to improved cardiac outcomes in vascular surgery.

The AP (9/3) reports that individuals "getting an artery unclogged or repaired were much less likely to die or have a heart attack afterward if they took" statins "before and after their operations," according to a study published in the New England Journal of Medicine. Investigators "enrolled nearly 500 patients who were not on statins and were going to have operations on their aorta or leg or neck arteries. For about a month before and a month after their surgery, half the patients took a statin; the" remaining patients were given a placebo. The researchers found that "within a month of the operation, 12 patients in the statin group, about five percent, had died or had heart attacks, compared to 25 patients, or 10 percent, of those who took a dummy pill."

MedPage Today (9/2, Emery) reported that the participants "who took the statin drug also saw a significant drop in total cholesterol, low-density lipoprotein (LDL) cholesterol, and two biomarkers for inflammation, interleukin-6 and C-reactive protein." HealthDay (9/2, Edelson) also covered the story.

Low doses of investigational, delayed-release version of prednisone may benefit RA patients, trial indicates.

MedPage Today (9/2, Gever) reported, "Low doses of an investigational, delayed-release version of prednisone relieved rheumatoid arthritis symptoms in a pivotal phase III trial" that included 350 patients, "paving the way for a US marketing application," Swiss-based Nitec Pharma announced. Investigators found that nearly "49 percent of the Lodotra group achieved ACR 20 responses (20 percent reduction in symptoms according to American College of Rheumatology criteria), compared with 29 percent of those taking placebo." It also "led to a mean 44 percent reduction in morning stiffness, compared with 21 percent in the placebo group. Both differences were highly significant."

Prazosin may reduce trauma nightmares, study suggests.

MedPage Today (9/2, Neale) reported, "Prazosin, a drug originally developed to lower blood pressure but used to treat veterans with post-traumatic stress disorder for years, appeared to reduce debilitating trauma nightmares in soldiers deployed to Iraq in a small, open-label study." For 13 soldiers "treated at a combat stress unit in northern Iraq, there was a significant reduction in mean scores for trauma nightmares and disturbed sleep." MedPage added, "Mean trauma nightmare score on the Clinician Administered PTSD Scale decreased from 7.0 to 2.9."

Also in the News

Union group asks FTC to investigate CVS-Caremark merger.

Bloomberg News (9/3, Wolf) reports that officials from Change to Win, a six million-member union federation, "said it asked the Federal Trade Commission at a meeting today to investigate whether the 2007 merger that created CVS Caremark Corp. has raised prescription drug prices." The union "alleges CVS overcharges consumers, sells private customer data and favors higher-priced drugs in order to collect manufacturer rebates, assertions the company says aren't true." The union also "joins five US senators who have requested a similar probe."

Officials: Pfizer to pay record $2.3B penalty

People familiar with a record settlement to be announced Wednesday say Pfizer Inc., the world's largest drugmaker, will pay a $2.3 billion civil penalty over unlawful prescription drug promotions.

Latest pharmacy news

Antiplatelet drugs, PPIs can be simultaneously prescribed to heart patients, investigators say.

According to Bloomberg News (9/1, Cortez), approximately "two million people worldwide undergo procedures to clear heart arteries each year, then take aspirin plus Plavix [clopidogrel] or Effient [prasugrel] from Eli Lilly & Co. and Daiichi Sankyo Co. to prevent re-clogging." What's more, these patients are "routinely prescribed pills" like Nexium [esomerprazole magnesium] or Prilosec [omeprazole], which are proton-pumps inhibitors (PPIs), "to reduce...stomach acid at the same time, since the other medications can cause gastrointestinal trouble." There have been "concerns that mixing the medications may reduce the effectiveness of" the "blood thinner."

Dow Jones Newswires (9/1, Favole) notes that "earlier this year, the FDA asked Plavix marketers Bristol-Myers and Sanofi to update the drug's label to warn of risks with the drug when used in combinations with PPIs." But new research by Brigham and Women's Hospital appears to contradict earlier studies.

For the study appearing online in The Lancet, WebMD (8/31, Boyles) reported, investigators analyzed the results of two trials -- TRITON-TIMI 38 and PRINCIPLE-TIMI 44 -- with the "larger of the two" including "about 13,600 patients who had a previous heart attack or unstable angina treated with one of the two drugs." One-third of the participants "were also taking a PPI, but PPI use was not found to be associated with an increased risk of a second heart attack, stroke, or cardiovascular death with either of the two anti-clotting drugs."

But "evidence of the pharmacodynamic effect of the PPI-thienopyridine interaction was clear in data from the PRINCIPLE trial,"MedPage Today (8/31, Peck) pointed out. Ralph G. Brindis, MD, MPH, President-elect of the American College of Cardiology, said that "even though there is evidence in the test tube that inhibition of platelet aggregation is diminished with PPI therapy, there is no clinical effect." The new findings should not "be construed as a signal to return to routine prophylaxis with PPI," he added. "But for high risk patients who need these drugs, I think we can be a little more confident using PPIs." Reuters (9/1, Hirschler) also covers the story.

Drug Approvals

FDA approves Valcyte to prevent cytomegalovirus in young kidney, heart transplant patients.

The AP (9/1) reports, "Roche said Monday the Food and Drug Administration approved Valcyte [valganciclovir hydrochloride] to prevent the common cytomegalovirus in children who have received kidney or heart transplants." Valcyte "is already approved to treat Cytomegalovirus Retina, an infection of the eye, in patients with AIDS," and "to prevent cytomegalovirus in kidney, heart and kidney-pancreas transplant patients at high risk."

HealthDay (8/31, Roberts) added that the FDA approved the drug for "children 4 months to 16 years who are undergoing kidney or heart transplant, Swiss drug maker Roche said Monday." Roche also said that as "part of the approval, the FDA sanctioned a new oral liquid form of the drug to allow for easier use in children."

FDA grants doxorubicin orphan drug status.

The AP (8/31) reported, "Delcath Systems Inc. said Monday the Food and Drug Administration gave its developing liver cancer treatment doxorubicin orphan drug status." The status "is given to drugs aimed at rare conditions or conditions that have a lack of treatments on the market," and allows "seven years of market exclusivity following FDA approval, assistance in clinical trial design, a reduction in user fees, and tax credits." The AP added, "Delcath focuses on using drug delivery technology that gives ultra-high doses of anticancer drugs to the liver."

Medication Use

FDA approves six new marketable volumes, concentrations of heparin.

The AP (9/1) reports, "Drug delivery system and device maker Hospira Inc. said Monday it received Food and Drug Administration approval to market the blood thinner heparin in six new volumes and concentrations." The doses "range from one milliliter to 30 milliliters in size," according to Hospira, and the "concentrations range from 1,000 units per milliliter to 10,000 units per milliliter." The AP adds, "The approval covers three single-dose vials and three multiple-dose vials."

Quality and Safety

Flu shot focus may be overshadowing necessity of meningococcal meningitis vaccination, experts say.

The AP (9/1) reports that although it can often initially seem "like a stomach bug or the flu," bacterial meningitis "can go on to kill terrifyingly fast." And, the "prime targets are tweens, teens and college freshmen." But there are concerns that the onslaught of flu shot headlines may be overshadowing the need to seek "vaccination against meningococcal meningitis." In the "two years since the government recommended that every adolescent be vaccinated, close to 40 percent of tweens and teens are." But while there "are multiple types of meningitis," nearly "15 percent of the people who catch this fast-moving germ die -- and one in five of the survivors --suffer permanent disabilities including brain damage, deafness or amputated limbs." So, many universities "now require freshmen to be vaccinated, whether they're dorm-dwellers or not." What's more, "a growing number of states are passing legislation making a meningococcal shot a requirement to enter certain grades."

Pharmacy medication errors may be ruled criminal

Every pharmacist makes mistakes, and all too often they are medication errors. Sometimes the system does not catch a medication error and it reaches a patient. Sometimes, thankfully not often, an error injures a patient.
In such an instance, we can be held liable in a civil suit for money damages as compensation for the injury. We carry malpractice insurance because we know that no matter how good we are, we will never eliminate the possibility of a negligent act that may result in human error and injury to a patient.
What if, however, our medication error resulted in a criminal charge? In May, an Ohio pharmacist pleaded "No contest" (essentially equivalent to a guilty plea without admission of guilt) to a charge of involuntary manslaughter. He faces up to five years in prison and a fine of up to $10,000.
We commonly think that a person charged with a crime is a "bad person." The pharmacist in the Ohio case was not a bad person, but a mistake occurred under his supervision that resulted in the death of a two-year-old girl.
There seems little question that negligence was involved. According to newspaper accounts and Board of Pharmacy minutes, a hospital pharmacy technician mistakenly mixed chemotherapy solution with 23.4 percent instead of 0.9 percent sodium chloride. The parents' civil suit charging negligence against the hospital was settled out of court.
Negligence charges are common in civil cases involving professional malpractice. In civil cases, negligence means deviation from professional standards of practice or failure to exercise due care. In criminal cases, negligence means something more. An earlier Ohio court explained:
A person is [criminally] negligent when, because of a substantial slip from the standard of care [the person] fails to take steps to evade a risk that his conduct may cause a certain result. ... It defines a higher degree of negligence than ordinary negligence. For one to be [criminally] negligent ... he must be guilty of a substantial departure from due care, whereas ordinary negligence merely requires a failure to exercise due care.
It does not happen often that a pharmacist is charged with a crime for a medication error. Whether the pharmacist in this case would have been found guilty had the case continued through a trial, we cannot know.
How can a pharmacist "take steps to evade a risk that his conduct may cause a certain result?" Every time we fill a prescription or drug order, there is a chance that we might make a mistake. When we dispense or compound dangerous drugs, i.e., ones that are designated Rx only, any selection of wrong drug or wrong strength could be a "substantial slip" if the only thing we judge by is the result. The only way to actually "evade a risk" of making a mistake that will result in a predictable (certain) outcome is to refuse to fill the prescription or drug order.
Mike Cohen, president of the Institute for Safe Medical Practices, said about this case, "Focusing on the individual is unlikely to have a positive effect in the long run. I have not read anywhere that he purposefully tried to hurt the patient." I agree; nothing I have read about this case indicates that the pharmacist's conduct rose to the level of a criminal violation. A criminal conviction here serves no purpose. It may also have a dangerous, unintended consequence and may result in injury to a future patient.
The Institute of Medicine (IOM) report "To Err Is Human" found that medical errors are among the leading causes of death in the United States; it estimated that each year 40,000 to 98,000 patients die in hospitals from preventable adverse events — medical errors. The IOM, as part of its report, cited studies estimating that there are 7,000 deaths each year just from medication errors. How many of the professionals involved in these cases should be put in jail?
Prosecutors and grand juries, the ones who make such decisions, are as much subject to pressure to "do something" as the rest of us. They need to think hard about this type of case in the future and resist easy, "feel good" decisions. I was taught in law school that a person should be able to conform his or her actions to avoid being charged with a crime. In this case, to conform your actions, you'd have to avoid being a fallible human being — or refuse to fill the drug order.
There is a reason we teach that when a medication error occurs, we fix the system and do not punish the person. This is the basis of risk management and avoidance of medication errors. Systems are in place because people make mistakes. If people never made mistakes, we wouldn't need systems. If systems never failed, none of our mistakes would ever reach a patient.
Routinely punishing the person who made the mistake may make it less likely that we will learn of every mistake. If we do not learn of an error, we will not have a chance to fix the system. The result will be that some day, some patient will be injured when we could have modified the system to prevent the error from reaching the patient. In the present case, it is the prosecutors who need to fix their system.
This article is not intended as legal advice; it is intended to promote thought about ways to reduce medication errors. For legal advice, consult your own attorney.

So far, generic drugs have not gone viral in America

When it comes to generic drugs, American consumers have much to learn about their cost, ingredients, and effectiveness, according to a recently released study by Prescription Solutions and UnitedHealth Group.
Generic drugs have saved the health system an estimated $734 billion over the past decade. Still, many Americans are apprehensive about using them. The study found that nearly a third of Americans surveyed don't believe generics have the same active ingredients as brand-name drugs, or are as effective. Two-thirds of those surveyed did not understand that generics are usually less expensive than brand-name drugs.
"Using generics helps make healthcare more affordable without compromising results. Many Americans erroneously believe that the most expensive drug is always the most effective drug," said Jacqueline Kosecoff, CEO of Prescription Solutions, a pharmacy benefit management organization. "By helping change perceptions, we can help people save money and still get the best treatment available."
As other studies have done, this latest one revealed that tough economic times have forced many Americans to change the way they manage their prescriptions. Specifically, 27 percent of those surveyed said that to save money they have delayed filling, not filled, or not taken a prescription drug as directed. "At a time when rising costs are taking an increasing toll on many American families, especially during the economic crisis, [we are] working to ensure that consumers have access to lower-priced generic drugs," Kosecoff said.
The study also showed that 21 percent of respondents had spoken to their physicians or pharmacists about switching to less expensive drugs. Of those who regularly take generics, 64 percent said that their physicians had suggested generics and 43 percent said their pharmacists had done so.
Nearly half, 47 percent, of all survey respondents take generics, with 82 percent of that group saying they do so because of the lower cost. Of those who do not take generics, 58 percent said there is no generic equivalent available for the drug they need. Of those who don't take generics, 58 percent said they would, if their pharmacists offered identical, less expensive substitutes.