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SATURDAY, Feb. 20 (HealthDay News) — The blockbuster type 2 diabetes drug Avandia raises users’ odds for heart attack and heart failure and should be removed from the market, according to confidential U.S. government reports.
The New York Times on Saturday reported on documents from the U.S. Food and Drug Administration that find that if people now taking Avandia (rosiglitazone) switched to a similar medication, Actos, about 500 heart attacks and 300 cases of heart failure would be eliminated each month. And in a report from the Institute for Safe Medication Practice, Avandia was linked to 304 deaths in the third quarter of 2009 alone, the highest for any prescribed drug in that time period, the Times reported.
In one of the FDA documents, dated October 2008, Drs. David Graham and Kate Gelperin — drug safety officials at the agency — agreed that “rosiglitazone should be removed from the market.”
The reports, obtained early by the Times, are yet another chapter in Avandia’s checkered history. The drug was once taken by millions worldwide, but that changed after a study released in early May of 2007 by the Cleveland Clinic suggested that Avandia carried cardiovascular risks. That study, which included more than 28,000 people, found that Avandia increased a user’s odds of heart attack by 43 percent compared to those not taking the medicine.
At the time, Dr. Bruce M. Psaty of the University of Washington — who also co-wrote an accompanying editorial in the New England Journal of Medicine — urged the FDA to restrict access to Avandia and cited both the agency and the drug’s maker, GlaxoSmithKline, for poor oversight.
“The primary problem here is that studies that were needed early on about the health benefits of this drug were never done,” Psaty told HealthDay. “As a result of the failure of the sponsor to do long-term clinical trials to show health benefits, as a result of the failure of the FDA to insist on it, we have data that are weak.”
Following on the Cleveland Clinic study, the FDA demanded “black box” warnings on labeling for both Avandia and Actos, warning of a potentially heightened risk for heart failure. However, other studies found no raised level of heart risk, and at the time the agency said it had not reached a definitive conclusion on the data.
In November of the same year, the FDA updated Avandia’s labeling to include a caution regarding heart attack risk. At the time, Dr. Janet Woodcock, acting director of the FDA’s Center for Drug Evaluation and Research, said that, “we are keeping Avandia on the market because we have concluded there isn’t enough evidence to indicate that the risk of heart attack is higher for Avandia than other type 2 diabetes treatments.”
The story got more complicated in 2008, as a number of studies emerged tying the use of Avandia to increased bone fracture risk.
Throughout 2009, more studies reiterating the drug’s heart risks also came to light, including one published in the BMJ suggesting that Avandia’s risk for heart failure seemed to outstrip those of its related rival, Actos.
By that point, “most clinicians [had] stopped using Avandia — some will use Actos instead or go to another class completely,” Dr. Carl J. Lavie, medical director of cardiac rehabilitation at the Ochsner Heart and Vascular Institute in New Orleans, told HealthDay at the time.
The emergence of the leaked documents on Saturday comes at a time when officials within the FDA seem to be at loggerheads over whether to ban Avandia or not, the Times reported. The newspaper said that some officials believe that safer alternatives exist, while others say the evidence on Avandia’s safety is conflicted and the drug should remain available as a treatment option.
Trying to sort things out, in December of 2009 Woodcock asked officials at the FDA to convene another advisory committee to determine whether Avandia should remain on the market, with a decision expected this summer.
In the meantime, a bipartisan Senate investigation — overseen by Sen. Max Baucus (D-Mont.) and Sen. Charles E. Grassley(R-Iowa) — has pored over 250,00 internal documents from GlaxoSmithKline. The investigation has placed much of the blame for the Avandia debacle on the company, contending that it neglected to warn patients for years of the drug’s dangers.
“G.S.K. executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk,” according to the Senate investigation report, which is slated for release Monday but was obtained early by the Times.
Speaking to the newspaper Friday night, agency commissioner Dr. Margaret Hamburg said that, “I await the recommendations of the advisory committee. Meanwhile, I am reviewing the inquiry made by Senators Baucus and Grassley and I am reaching out to ensure that I have a complete understanding and awareness of all of the data and issues involved.”
In a statement released Saturday, GlaxoSmithKline said it “rejects the conclusions about the safety of Avandia (rosiglitazone)” as reported in that day’s Times story.
“Contrary to the assertions in the story, and consistent with the FDA-approved labeling, the scientific evidence simply does not establish that Avandia increases ischemic cardiovascular risk or causes myocardial ischemic events,” the company said. “In 2007, the FDA considered all the available scientific evidence on Avandia, including Dr. Graham’s assertions of elevated heart attack risk and demands that the product be withdrawn. Based on the scientific evidence and a recommendation by an independent advisory committee of experts convened by the FDA, the agency has ruled that Avandia remain available to patients for the treatment of Type 2 diabetes.”
In the wake of the controversy, GlaxoSmithKline had been directed by the FDA to conduct a trial comparing rates of heart attacks, strokes and heart-linked deaths among users of Avandia, Actos or a placebo. But according to internal documents accessed by the Times, Graham and Gelperin characterized the study, called TIDE, as “unethical and exploitive,” with patients being given Avandia despite the fact that it appears to come with greater risks and no added benefit over Actos.
One of the Graham/Gelperin reports — dated October 2008 — concludes that, “Although the proposed TIDE trial is motivated by a desire for definitive answers regarding the cardiovascular safety of the drug rosiglitazone, the safety of the study itself cannot be assured and is not acceptable.”
However, other FDA officials overruled those concerns and TIDE is still enrolling patients, with preliminary results expected by 2014. Responding to the criticism, GlaxoSmithKline noted Saturday that, “TIDE has been approved by an independent review board and appropriate safety boards that are responsible for assessing the safety of conducting the trial.”
The ongoing controversy has dampened patients’ and physicians’ enthusiasm for Avandia. According to the Times, while sales of the drug topped $3.2 billion in 2006, those numbers plummeted soon after the first studies suggesting risk emerged a year later.
Still, “hundreds of thousands” of people still take Avandia, the Times noted. GlaxoSmithKline’s patent on the drug expires in 2012.
By E.J. Mundell
HealthDay Reporter
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Two new drugs — both oral, rather than injected — may soon be available to combat multiple sclerosis.
Three studies, all being published early online Jan. 20 in the New England Journal of Medicine, find that the new drugs — fingolimod and cladribine — reduce relapse rates in people with relapsing-remitting multiple sclerosis (MS). Both drugs work by altering the immune system response.
However, as is often the case with immune-suppressing medications, there are concerns about side effects, including an increased risk of serious infections and possibly, cancer.
“Oral drugs are what people with MS have been wishing for a long time. This is wonderful news for people with MS,” said Dr. John Richert, executive vice president of research and clinical programs for the National Multiple Sclerosis Society (NMSS). “The drugs appear to be quite effective, and at the moment, appear to have a reasonable risk-benefit ratio. However, it will be very important for people with MS and their physicians to remain vigilant and be on the lookout for side effects.”
All three studies were funded by the drug’s manufacturers — Novartis for fingolimod and Merck Serono for cladribine. Both manufacturers are currently pursuing U.S. Food and Drug Administration approval for their medications.
Multiple sclerosis is a chronic, potentially disabling illness that’s believed to be an autoimmune disorder. In MS, the body’s natural defense system mistakenly attacks the fatty substance that protects the nerves (myelin). About 400,000 Americans have multiple sclerosis, according to the NMSS.
The current treatments for MS are all injectable medications, which Richert said is sometimes a barrier for people to start early treatment. He said that treatments may be more successful if they’re started early in the course of the disease, so he’s hoping that having oral medications will help people start treatment sooner.
Two of the new studies focused on the oral medication called fingolimod. Both were phase 3 studies. One study included more than 1,000 people with relapsing-remitting MS. The study participants were randomly selected to receive a daily dose of 0.5 milligrams (mg), 1.25 mg or a placebo.
Annual relapse rates were less than 1 percent each year, but were 54 percent less for the lower dose of fingolimod and 60 percent for the higher dose. The study also found slower disease activity and progression.
In the second study on fingolimod, 1,153 people with relapsing-remitting MS were randomly assigned to receive a daily dose of 0.5 mg or 1.25 mg of fingolimod or a weekly dose of 30 micrograms of interferon beta-1a (Avonex) for one year. The annual relapse rate on either drug was less than 1 percent in this study as well. However, the people on fingolimod had up to a 52 percent lower relapse rate. This study found no significant differences in disease progression between the two treatments.
Both studies found that the lower dose of the drug was better tolerated. A small number of serious infections occurred, including two deaths from herpes infections in these studies. And, there appeared to be a higher incidence of cancer in people taking fingolimod.
Still, “the fact that fingolimod is given orally is a huge advantage,” said the lead author of the yearlong study, Dr. Jeffrey Cohen, director of experimental therapeutics at the Mellen MS Center at the Cleveland Clinic in Ohio. “It appears to be effective and is generally well-tolerated.”
The third study, also a phase 3 study, looked at the oral medication cladribine in comparison to placebo. In this study, more than 1,300 people with relapsing-remitting MS were randomly assigned to receive a cladribine dose of either 3.5 mg or 5.25 mg per kilogram of body weight or a placebo. During the second year of the study, those on cladribine were all given the lower dose.
As in the fingolimod studies, annual relapse rates were less than 1 percent. However, those on cladribine had relapse rates that were up to 58 percent lower. Disease activity and disability scores were also lower in the treatment groups.
Although the drug appeared to be generally well-tolerated, there were some serious side effects with cladribine as well, including serious herpes zoster infections. Herpes zoster is the virus that causes shingles, and there is a vaccine available for this virus. Whether getting the vaccine prior to treatment would lessen the risk of infection isn’t clear because it hasn’t been studied, said Richert. Cladribine was also associated with a potentially increased risk of cancer.
Another question that remains to be answered for both medications is whether or not they will increase the risk of a very serious brain infection known as progressive multifocal leukoencephalopathy (PML). It wasn’t discovered that the MS medication, natalizumab (Tysabri), caused a slight increase in the rate of these infections until the drug came to market. That’s because it’s such a rare side effect.
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Elderly black Americans use fewer medications than whites and are more likely to skip taking their meds, a new study finds.
It included 100 black and 100 white patients, aged 60 and older, who were interviewed at the start of the study, and again six months and one year later.
Overall, whites used more medications, had more chronic medical conditions and used more physicians. Whites were more likely than blacks to have adequate health literacy skills (58 percent vs. 29 percent) and less likely to be unable to afford medications (12 percent vs. 28 percent).
The most common problems for both whites and blacks were: medication non-adherence (42 percent vs. 68 percent), under treatment (83 percent vs. 87 percent), suboptimal drug use (59 percent vs. 66 percent), and suboptimal dosing (48 percent vs. 56 percent).
The findings support previous research showing that elderly black patients have higher rates of medication non-adherence than whites. But, overall, medication-related problems are prevalent and persist in both races, the researchers said.
“Strategies to better measure the quality of medication use in older adults are needed, and efforts to improve the quality of medication use in older adults must account for potential differences in both the number and types of problems affecting whites and blacks,” concluded Dr. Mary Roth and her colleagues at the University of North Carolina at Chapel Hill.
The study was published online Dec. 11 in the Journal of General Internal Medicine.
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U.S. regulators see benefits to using an AstraZeneca Plc cholesterol drug in a vast new group of patients but will ask outside advisers to probe various safety issues, documents released on Friday said.
AstraZeneca wants permission to promote the Crestor drug, for preventing heart disease in people with normal cholesterol levels but other risk factors based on findings of a large study known as Jupiter.
A Food and Drug Administration reviewer, commenting on a higher number of diabetes cases reported with Crestor patients, said that, at the current time, the benefits seen in the Jupiter trial “outweigh the risk, but further clinical trials are needed to further define this benefit/risk ratio.”
The Jupiter trial “was relatively short in duration” and “therefore the long-term complications are unknown,” the reviewer said.
The reviewer also said the agency felt it was a “chance finding” that gastrointestinal-related deaths were higher in Crestor patients compared with a placebo.
The comments were included in documents the FDA released ahead of a meeting on Tuesday of a panel of outside advisers.
The advisory panel will be asked to comment on the diabetes and gastrointestinal findings before deciding whether to recommend approval for expanded use, according to a November 12 memo. The FDA also will seek input on a higher number of patients who reported a “confusional state” in the Crestor group, the memo said.
Barclays Capital analyst Brian Bourdot said he expects the advisory panel to support wider use of Crestor.
“Overall, the FDA review appears benign, with few safety concerns and little disagreement that Crestor shows a significant benefit” in the expanded group, Bourdot said in a note to clients.
The Jupiter study showed Crestor cut deaths, heart attacks and strokes in middle-aged people with healthy cholesterol, but elevated levels of C-reactive protein, which is associated with heart disease.
The FDA said it would ask the advisory panel to “keep in mind that an estimated 6 million middle-aged and older men and women in the United States” meet the criteria of people in the study.
AstraZeneca said in an analysis also released by the FDA that Crestor’s risks in the Jupiter study were “consistent with the known safety profile.” The company said potential side effects were outweighed by the benefits, including a 44 percent reduction in cardiovascular-related deaths, strokes, heart attacks and other problems.
An expanded label for Crestor would boost sales of the drug in the coming years, but industry analysts say the size of the opportunity is uncertain because of the looming arrival of generic versions of Pfizer Inc’s Lipitor in late 2011.
Gbola Amusa of UBS believes the Jupiter results could expand the overall statin market by 20 percent to 50 percent in volume terms, lifting AstraZeneca’s Crestor sales to some $8 billion in 2012 from $3.6 billion last year.
Others are more cautious, and the consensus forecast for 2012 is $6.75 billion, rising to $6.92 billion in 2013, according to Thomson Pharma.
AstraZeneca’s partner Shionogi & Co Ltd also sells Crestor in Japan and recorded $172 million in revenue from the drug in 2008.
The dramatic reduction in heart attack risk seen in Jupiter already has helped boost prescriptions for Crestor since details were unveiled in November last year.
The FDA will make the final decision on whether to allow AstraZeneca to promote Crestor more widely, but it usually follows panel recommendations.
Crestor is a key driver for AstraZeneca as other drugs go off patent, but its exclusivity through to 2016 is being challenged by generic manufacturers in a case due to go to trial in February 2010. AstraZeneca has requested a summary judgment ahead of the trial to eliminate the most significant issue in the case and is awaiting the judge’s decision.
AstraZeneca shares rose 0.9 percent to $45.77 in afternoon trading on the New York Stock Exchange.
(Reporting by Lisa Richwine and Ben Hirschler; editing by Gerald E. McCormick and Andre Grenon)
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The number of Americans with diabetes will nearly double over the next 25 years, rising from 23.7 million in 2009 to 44.1 million in 2034, according to a study by the University of Chicago.
In the same period, medical costs associated with treating the disease will triple from 113 billion dollars to 336 billion dollars, even without a rise in the incidence of obesity, according to the study published in the December issue of Diabetes Care.
“If we don’t change our diet and exercise habits or find new, more effective and less expensive ways to prevent and treat diabetes, we will find ourselves in a lot of trouble as a population,” said lead author Elbert Huang.
The study said its projections, despite being significantly higher than other recent estimates, may be too conservative because they assume the rate of diabetes and obesity, a risk factor for the disease, will remain stable.
In 1991, scientists projected that the number of Americans with diabetes would reach 11.6 million people in 2030, but some 20 years before that date the figure is already double that.
The study’s authors acknowledge that obesity rates have risen steadily in past years, but predict that they will level out over the next decade and then decline slightly from the current 30 percent level to around 27 percent in 2033.
The US health program Medicare, which provides health care for older Americans, spends some 45 billion dollars a year on diabetes treatment for 8.2 million people.
By 2034, the number of people with diabetes covered by the program is expected to rise to 14.6 million, according to the study, with associated costs rising to 171 billion dollars a year.
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WASHINGTON – Federal health officials said Tuesday a popular variety of heartburn medications can interfere with the blood thinner Plavix, a drug taken by millions of Americans to reduce risks of heart attack and stroke.
The Food and Drug Administration said the stomach-soothing drugs Prilosec and Nexium cut in half the blood-thinning effect of Plavix, known generically as clopidogrel.
Regulators said the key ingredient in the heartburn medications blocks an enzyme the body needs to break down Plavix, muting the drug’s full effect. Procter & Gamble’s Prilosec OTC is available over-the-counter, while AstraZeneca’s Nexium is only available with a prescription.
“Patients at risk for heart attacks or strokes who use clopidogrel to prevent blood clots will not get the full effect of this medicine,” the agency said in a statement.
Plavix is marketed by Sanofi-Aventis and Bristol-Myers Squibb. With global sales of $8.6 billion last year, it’s the world’s second-best selling drug behind Pfizer’s cholesterol drug Lipitor.
Because Plavix can upset the stomach, it is often prescribed with stomach acid-blocking drugs.
The FDA says patients who need to reduce their acid should take drugs from the H-2 blocker family, which include Johnson & Johnson’s Mylanta and Boehringer Ingelheim’s Zantac. FDA scientists say there is no evidence those drugs interfere with Plavix’s anti-blood clotting action.
Nexium and Prilosec are part of a class of drugs known as proton pump inhibitors, but FDA regulators said they don’t have enough information to say whether other drugs in that class shouldn’t be used with Plavix.
“There’s not enough data to tell us how those drugs interact with,” the enzyme that activates Plavix, said Mary Ross Southworth, FDA’s deputy director for safety of cardiovascular products. “There are ongoing studies looking at those other drugs.”
The FDA said the warnings on Plavix have been strengthened based on a 150-patient study submitted by Sanofi over the summer.
But some consumer advocates said the agency’s action fell short, arguing that regulators should have placed the information in a “black box” warning label, the most serious available.
“This information still has not risen to as prominent a level of warning as it should have,” said Dr. Sidney Wolfe, director of health research at the consumer advocacy group Public Citizen.
Information about the drug interaction between Plavix and other medications is not new. Researchers at pharmacy benefit manager Medco Health Solutions reported last year that taking Plavix with Nexium significantly increased patients’ chances of being hospitalized for a heart attack, stroke or chest pain.
In May, Sanofi and Bristol-Myers updated Plavix’s labeling to advise against using it in combination with certain heartburn drugs.
A Sanofi spokeswoman said Tuesday that the company has bolstered that language labeling.
“We’ve strengthened the label to say that these drugs should be avoided altogether, not just discouraged,” said Noelle Boyd, Sanofi’s senior communications director.
WBB Securities analyst Steven Brozak said the news would put pressure on Paris-based Sanofi and New York-based Bristol-Myers to provide more safety data on their best-selling product.
“This is going to create a chain reaction as patients start calling their physicians, and they are forced to make a spot decision on limited information,” said Brozak. “That’s not gonna help either company’s bottom line.”
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ATLANTA – Cigarette smoking rose slightly for the first time in almost 15 years, dashing health officials’ hopes that the U.S. smoking rate had moved permanently below 20 percent.
A little under 21 percent of U.S. adults said they smoked, according to a 2008 national survey by the U.S. Centers for Disease Control and Prevention. That’s up slightly from the year before, when just 19.8 percent said they were smokers. It also is the first increase in adult smoking since 1994, experts noted.
The increase was so small, it could be just a blip, so health officials and experts say smoking prevalence is flat, not rising. But they are unhappy.
“Clearly, we’ve hit a wall in reducing adult smoking,” said Vince Willmore, spokesman for the Campaign for Tobacco-Free Kids, a Washington, D.C.- based research and advocacy organization.
There’s a general perception that smoking is a fading public health danger. Feeding that perception are indoor smoking laws, cigarette taxes and Congress’ recent decision to allow the Food and Drug Administration to regulate tobacco.
But health officials believe gains have been undermined by cuts in state tobacco control campaigns. Some advocates believe tobacco companies are overcoming increasing obstacles.
Cigarette marketing has persisted and is effectively reaching kids and minorities with messages about flavored or menthol products, said Dr. Clyde Yancy, president of the American Heart Association.
The tobacco industry also has been discounting cigarettes to offset tax increases and keep smokes affordable, Willmore said.
Between 1997 and 2004, the average retail price of a pack of cigarettes — adjusted for inflation — jumped 63 percent, and adult smoking declined about 15 percent. Between 2004 and 2008, the price rose just 2 percent, while adult smoking declined by just about 1 percent, he said, citing industry sales data.
“There’s a clear correlation,” Willmore said.
Cigarette smoking is the leading preventable cause of death and illness in the United States, and is a cause of cancers, heart disease and other fatal conditions.
The adult smoking rate has been dropping, in starts and stops, since the mid-1960s when roughly 2 out of 5 U.S. adults smoked. Now it’s 1 in 5. However, federal health goals for the year 2010 had hoped to bring the rate down to close to 1 in 10.
Adult smoking hovered at about 21 percent from 2004 to 2006, then dropped a full percentage point in 2007, said Dr. Matthew McKenna, director of the CDC’s Office on Smoking and Health.
The 2007 drop gave CDC officials hope that U.S. smoking was plummeting again. “Now that appears to be a statistical aberration,” McKenna said.
The new survey’s results come from in-person interviews of nearly 22,000 U.S. adults.
The study was released Thursday, published in the CDC publication, Morbidity and Mortality Weekly Report.
Also on Thursday, the CDC released state-by-state results on smoking from a different survey, conducted by telephone, of more than 400,000 adults. West Virginia and Indiana had the highest smoking rates, at about 26 percent, but four other states — Kentucky, Missouri, Oklahoma and Tennessee — had rates about as high.
Utah had, by far, the lowest smoking rate, with only about 9 percent of Utah residents describing themselves as current smokers.
Many of the states that have the lowest smoking rates are those that have been the most aggressive about indoor smoking laws and about state taxes that drive up the cost of cigarettes, said Dr. Thomas Frieden, the CDC’s director.
Health officials are optimistic that more and more smokers will be discouraged from lighting up by escalating cigarette taxes, including a 62-cent federal tax that took effect in April. That may cause smoking to go down when the 2009 smoking data comes in, some advocates said.
Perhaps the recession will have an impact, too.
“In general, when people have less money, they smoke less,” Frieden said. “Time will tell.”
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WASHINGTON - As federal regulators take their first tentative steps toward policing the wild west of medical information online, pharmaceutical companies are pressing their case to market drugs via Google, Twitter and other Web sites.
The Food and Drug Administration will convene a two-day meeting beginning Thursday to hear the drug industry’s position on Internet marketing. The agency has agreed to consider developing rules for online advertising after companies complained that the current guidelines for traditional media — which require a detailed list of possible side effects — have left them hamstrung on the Web.
An estimated 83 percent of Internet users search for health information online, according to a recent survey from the Pew Research Center.
A few drugmakers have begun trying to reach patients via social networking sites like Facebook and YouTube. But overall the industry’s online presence trails other sectors, including retail, financial services and computer makers.
In the first half of 2009, pharmaceutical companies represented just 4 percent of the $10.9 billion spent on online advertising, according to a report from PricewaterhouseCoopers.
Industry observers say companies have largely steered clear of the Web for fear of running afoul of FDA regulators, who have not defined the rules of operating online.
In a public statement announcing the meeting, the FDA acknowledged that “emerging technologies may require the agency to provide additional guidance.” But some industry experts worry the FDA’s rule development process — which often takes years — cannot keep pace with online innovation.
“What’s happening is these new media are emerging at an increasingly rapid rate, and are being regulated by an agency that moves very slowly,” said attorney Mark Senak, who advises drug companies as a consultant for communications firm Fleishman-Hillard. “In essence, you have a regulatory communication crisis developing.”
The vast majority of the pharmaceutical industry’s roughly $4.5 billion in annual marketing is still spent on traditional TV and magazine advertising, where the rules are clear: all ads that mention a drug must provide a balanced picture of its risks and benefits.
The requirement to disclose risk information demands those long lists of side effects heard during TV and radio spots, as well as the large blocks of small print seen in magazine ads.
When drug companies have tried to adapt such ads to the abbreviated language of Google and Yahoo, they’ve run into trouble. In April, the FDA fired off warning letters to Pfizer Inc., GlaxoSmithKline PLC and a dozen other drugmakers for search engine ads that did not mention drug risks.
The ads — called sponsored links — appear on the screen margins of sites like Google when users search for certain key words. With a maximum of just 25 words, the links did not include information about potential side effects, making them illegal, according to the FDA.
On Thursday, the Pharmaceutical Research and Manufacturers of America group will argue that the FDA should relax its standards to accommodate new online approaches to marketing.
In documents released ahead of the meeting, PhRMA suggests the agency develop a logo that could be used in place of hundreds of words about drug risks. The logo would link viewers to the drug’s full risk information, allowing manufacturers to send messages about their drugs on sites like Twitter, which has a 140-character limit.
But industry observers say the online marketing environment is not as restrictive to drugmakers as some suggest. Pharma Marketing News publisher John Mack says drug companies already are free to post abbreviated ads about diseases and treatments — provided they don’t mention a specific product.
“They are very hell-bent on including brand names in their ads,” said Mack. “If all they wanted to do is direct people to useful health information, there are lots of ways to accomplish that.”
PhRMA will also press the FDA to narrowly define drug companies’ responsibility for policing information about their products.
Pharmaceutical promotions can only discuss drug uses that have been cleared by the FDA. But manufacturers worry they could be held responsible for comments about unapproved uses posted by users of blogs and interactive Web sites like YouTube, where some drug companies offer videos about diseases and medical science.
“Pharmaceutical companies control their own sites, their own agents and their own employees,” PhRMA assistant general counsel Jeffrey Francer said in a media briefing Monday. “But there is no sensible basis to hold manufacturers accountable for third-party statements.”
The FDA also is slated to hear from individual drug companies, medical device makers, attorneys and advertising executives.
Even after the FDA transcribes and reviews hours of testimony, the agency will only be in the preliminary stages of crafting new guidelines. According to Senak, the FDA is unlikely to release its final regulations until 2011 — when they may already be outdated.
“The danger is that the agency takes so long to get this done, and done right, that tremendous opportunities are lost,” said Senak.
A spokeswoman for the FDA declined to comment on the agency’s timeline.
“Next steps after the meeting will be to review all the testimony provided at the hearing and the comments, information and data submitted to the docket,” Shelly Burgess wrote in an e-mail.
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WASHINGTON (Reuters) – Democratic leaders moved on Friday to build support among the elderly for a massive overhaul of the U.S. healthcare system, saying the measure would immediately start closing a gap in Medicare prescription drug coverage.
The coverage gap, the so-called doughnut hole, occurs after a certain amount of money is spent. This year that level is $2,700 of which $896 is out of pocket expenses by the beneficiary. Coverage begins again once drug costs reach $6,154.
Speaker Nancy Pelosi said the healthcare reform bill being considered by the House of Representatives would reduce the that doughnut hole and lower the cost of medicine for as many as 4 million elderly next year.
“As of January 1, 2010, our legislation will give a 50 percent discount for brand-name drugs to recipients in the doughnut hole, and it will reduce the size of the doughnut hole by $500,” Pelosi said.
An earlier version of the bill would have started closing the doughnut hole beginning in January 2011.
House Democratic leaders are working to merge three healthcare reform bills approved by committees into a single bill that can pass the House and give President Barack Obama a major victory on a top domestic priority.
The emerging bill would also gradually eliminate the gap in prescription drug coverage in 10 years. The earlier version of the bill would have eliminated the gap in 15 years.
Skeptical seniors
Medicare is a popular government health program for the elderly and many are worried that the sweeping healthcare overhaul, which includes some spending cuts in Medicare, would hurt benefits. Recent polls show the elderly are more skeptical than others about healthcare reform.
Support from the elderly, who are more likely to vote in elections than other demographic groups, is crucial to enacting healthcare reform. Closing the doughnut hole could go a long way toward winning their support and is a top priority for the AARP, an influential advocacy group for the elderly.
Republicans argue that the proposed spending cuts, mostly to the Medicare Advantage programs run by private companies, would lower benefits in those programs.
Democrats say the proposed cuts may affect some extras in those programs, like paid gym fees, but would not reduce basic benefits.
“Millions and millions of dollars in ads and lobbying are being pumped out to scare and confuse the public about health reform, all designed to stop the legislation,” said House Democratic Whip James Clyburn. “Their top target: seniors and their beloved Medicare program.”
Seniors fall into the doughnut hole once $2,700 is spent on prescription drugs, including $896 out-of-pocket costs. After that, beneficiaries have to pay 100 percent of drug costs until a total $6,154 is spent. Once that level is reached, catastrophic coverage kicks in and almost all of the cost of drugs are covered.
Healthcare reform legislation working its way through the Senate also includes provisions aimed at reducing the Medicare prescription drug coverage gap.
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About 20 percent of U.S. teens exchange prescription drugs such as antibiotics and allergy medications with friends, a practice that can be dangerous and potentially deadly, warns a new study.
For example, a teen who’s taking the acne medication Accutane — which has been linked to birth defects — may give some to a friend who is pregnant but doesn’t yet realize it, the researchers said.
They interviewed 592 adolescents, aged 12 to 17, and asked them if they’d ever “borrowed” or “loaned” a prescription drug. If so, the teens were asked what kind(s) of drugs were exchanged, if they gave or received any warnings or instructions with the medications, and about outcomes.
Besides finding that about a fifth of those surveyed had swapped a prescription medication with a friend, the study also found that almost a third of teens who took a “borrowed” prescription didn’t tell their doctor. That type of situation can lead to unforeseen drug interactions, according to lead author Richard Goldsworthy, director for research and development at Academic Edge, Inc. and colleagues.
“Other researchers have studied people selling prescription drugs, but we looked at people with good intentions, trying, for instance, to help a friend who lacked money or transportation for a doctor’s visit,” co-author Chris Mayhorn, an associate professor of psychology at North Carolina State University, said in a news release from the Center for the Advancement of Health.
The study appears online in the Journal of Adolescent Health.
The findings are important “for physicians, prevention coalitions, school counselors, parents and the youth themselves,” Melissa Haddow, director of the Community Partnership of the Ozarks, said in the news release.
Previous studies found that almost 40 percent of U.S. adults “loan” or “borrow” prescription drugs.
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