The headline above comes from a Knight Ridder newswire story. It depicts the two-year path it took for a cheaper generic version of the allergy drug Flonase to make it on the market.
An excerpt: "The delay was the result of a series of aggressive administrative and legal maneuvers by GlaxoSmithKline that thwarted the speedy entrance of the generic. After a federal judge in Baltimore rebuffed Glaxo's final legal challenge on March 6, the generic version by Roxane Laboratories hit store shelves. The generic sells for $61.99 at Walgreens.com, while Flonase costs $81.99. At CVS.com, the generic is $68.59 vs. $85.29 for Flonase.
For consumers, the case shows that good things eventually come to those who wait. But it also shows that a generic drug's path to the retail market is often long and contentious. The price and market share for a brand-name drug fall dramatically when a generic alternative becomes available, so former patent holders do all they can to stave off the competition.
According to Bain & Co., an international consulting firm, patents are set to expire on 75 brand-name drugs over the next two years and on an unprecedented 252 by 2014. A study by the Pharmaceutical Care Management Association released on April 18 found consumers and health plans could save more than $26.4 billion over the next five years by using cheaper generic versions of just 14 brand-name drugs scheduled to lose their patent protection between now and 2009."
The Washington Post reports that the Federal Trade Commission is frustrated with its inability to stop brand-name drug companies from cutting million dollar deals with generic drug makers to keep the cheaper generics off the market.
Two federal appeals court rulings last year rejected FTC actions that since the late 1990s had prevented brand-name companies from paying their rivals to drop patent challenges.
The Post reports: "An FTC analysis found at least seven such agreements so far in fiscal 2006, with three in 2005. Before that, no generic companies had been paid to drop their patent challenges for years.
Speaking (Monday) in Philadelphia, FTC Commissioner Jon Leibowitz said that if the appeals court decisions remain in force, rival drugmakers will have 'carte blanche to avoid competition and share resulting profits.' He said the commission had agreed to ask the Supreme Court to overturn one of the lower-court decisions.
'Until recently, payments by brand-name companies to generics were the exception, but now they're the rule,' he said in an interview after his speech. 'They appear to be a new way to do business, and that's very troubling. Hopefully the Supreme Court will take our case and reverse.'
Yeah, it's great to be alive in the era of consumer-driven health care in America!
The Center for Science in the Public Interest (CSPI) says the Food and Drug Administration’s (FDA) advisory committee on cardiovascular and renal drugs will be chaired by and dominated by industry-connected scientists when it meets today to evaluate draft labeling guidance for antihypertensive drugs. CSPI has urged the FDA to postpone the meeting to take the time to identify panelists who are free of conflicts of interest, and who could bring balance to the panel.
A balanced panel would at least have some members with expertise on how hypertension can be treated with diet and lifestyle changes, according to CSPI.
“American hospitals and medical school faculties are filled with experts on preventing and treating high blood pressure, and it is simply not the case that all of them have financial relationships with drug makers,” said Merrill Goozner, director of the Integrity in Science Project at CSPI. “If the FDA can’t find any to serve on this particular panel, we stand ready to help them identify some.”
CSPI also told the agency that its draft labeling guidance ignores the government’s own advice on the importance of lifestyle changes on lowering blood pressure, misrepresents the findings of the major government-funded science on hypertension, and would permit drug companies to make claims on drug labels that have not been reviewed by FDA. CSPI says that the labeling guidance would open the door for labeling abuse by letting drug companies tout the advantage of one drug over another without much evidence, and would squander and opportunity to educate Americans about the importance of diet and lifestyle in treating hypertension.
“The FDA acts as if it is much more concerned with pampering the pharmaceutical industry than it is preventing disease through better diets,” said CSPI executive director Michael F. Jacobson. “The best science on blood pressure shows that adoption of healthy lifestyles, including losing weight and reducing sodium, is indispensable to reducing blood pressure. Yet FDA does very little to help Americans make those changes.”
The Star Tribune published two letters to the editor yesterday regarding the awarding of stock options to CEO Dr. Bill McGuire and board members of UnitedHealth.
One came from a former competitor, a rare intra-industry shot in health care. Dr. Donald Woodley, medical director of Blue Cross Blue Shield (MN) from 1973- 1985, wrote: "As a former medical director, I was always embarrassed by the money Dr. Bill McGuire was sucking out of the health care system. However, I always thought the board would watch over this and keep it within reason. Now I understand why no action was taken. The board members were too busy lining their own pockets with millions of dollars in stock options."
Another citizen wrote: "In nearly three decades of working with low-income, uninsured or underinsured persons, I have observed their difficulties in securing affordable health care coverage and, in turn, the health care they desperately need. As such, I read with dismay and disgust April 20 of the excesses characterizing Dr. William McGuire's compensation and UnitedHealth Group's compensation strategies -- excesses that may well have been inflated by the timing of stock options that were exercised.
A commitment to legalistic ethics may meet minimum standards, but we expect more from community leaders. As McGuire and UnitedHealth Group justify compensation practices and the timing of stock options, they must be reminded that just because something is not illegal does not mean it isn't fundamentally wrong.
The compensation practices of UnitedHealth directly affect the affordability of coverage, systematically keep many people from acquiring coverage and, arguably and ultimately, are a violation of Hippocrates's famous admonition that compels health providers 'above all else, to do no harm.' "
Journalist Merrill Goozner, on his blog, calls “attention to some of the complexities that underscore why the FDA’s draft 'Guidance for Industry for Labeling for Outcome Claims for Drugs to Treat Hypertension,' which will be discussed (this) week by the Cardiovascular and Renal Drugs Advisory Committee, is such a curious document. It isn’t so much that it is wrong. It’s what it leaves out and, more importantly, what it puts in that makes one wonder if the agency has sold its soul to the drug industry. …
The medical literature is filled with industry-funded studies that measure the antihypertensive effects of specific agents on patients that have other problems like kidney disease or peripheral arterial disease. These trials, which are sometimes referred to as ‘seeding trials,’ are a way to highlight one drug within this crowded field by getting articles about it published in specialty journals. If the FDA allows these trials to be included on labels, it allows drug detailers to mention that ‘benefit’ to physicians. In essence, it puts the FDA imprimatur on some of the most abusive sales tactics in today’s pharmaceutical marketplace.
Some might argue this is only guidance. Companies don’t have to follow it. Physicians and patients don’t read labels anyway. All true.
But the savvy marketing arms of the major drug companies know what’s at stake. Combine a failure to distinguish between drugs with the right to put the misleading claims of seeding trials on labels and what you’ve given them is a blank check to suggest their pricey patented drugs are superior to generic diuretics, even though the government guidelines say just the opposite. The net effect of this Guidance could be a huge setback for public health and the public purse.”
For a long time there have been questions about how certain new mental disorders become classified in psychiatry's recognized "bible" of definitions - the DSM or Diagnostic & Statistical Manual.
Now a study reported in the New York Times shows that "more than half the psychiatrists who took part in developing a widely used diagnostic manual for mental disorders had financial ties to drug companies before or after the manual was published."
The study's lead author said that although the study could not prove that the psychiatrists' ties influenced the manual's development, "what we're saying is it's outrageous that the manual doesn't have a disclosure policy."
OK, so many news stories today are reporting the new statistics suggesting (with lots of head-scratching and remaining doubts by some observers) that the U.S. had the biggest single-year decline in deaths since 1938.
If true, who or what gets the credit?
The Star Tribune, in its first sentence,says it's "a powerful testament to medical advances." It quotes a state health department official attributing it to "technology" and drugs.
Whoa! Where is any discussion of prevention, of lifestyle changes, of a "powerful testament to public health"?
This journalism-juiced love affair with high tech and emphasis on medicine with minimal or no mention of public health is troubling, sensational, and short-sighted. We need to remember: the U.S. spends more on health care than any other country and has outcomes worse than many other countries. People in countries that spend less on technology and drugs live longer than Americans.
Not only do these statistics demand more scrutiny, as many have already stated, but so do the possible explanations for any possible decline in the death rate. Journalists, don't be cheerleaders for high-tech and drugs if you don't have the evidence to back that up.
On Monday, the National Cancer Institute (NCI) announced early results from a trial comparing raloxifene and tamoxifen in preventing breast cancer in postmenopausal women at high risk.
The NCI announcement, and news coverage of it, left much to be desired. In most accounts, the NCI said both drugs cut the number of new cases of breast cancer in half, but women taking raloxifene experienced fewer serious side effects such as blood clots and cancer of the uterus. But half of what? They used relative risk reduction figures. Most people are better served by being told the absolute risk reduction - half of what starting point?
The National Women's Health Network (NWHN) says on its website:
"The NCI stressed the raloxifene benefit in its announcement, stating 'For many women, raloxifene’s benefits will outweigh its risks in a way that tamoxifen’s benefits do not.' NWHN is more cautious about the results of the trial, and believes that the breast cancer benefit of raloxifene may only be useful to a very small number of women."
The NWHN goes on to post: "NCI’s announcement doesn’t include much of the information that careful women and health care providers need to evaluate the overall risks and benefits of these drugs. We must also remember that the results have not yet been reviewed by experts who weren’t involved in the study (a requirement before the research can be published in a major medical journal), nor has the Food and Drug Administration (FDA) examined the records of the study to determine whether the agency will approve raloxifene for breast cancer risk reduction. ... We don’t know whether or not raloxifene, or tamoxifen for that matter, truly prevents breast cancer, or just delays it. NCI’s earlier trial of tamoxifen compared to a placebo only followed women for two years after they stopped taking their pills, not nearly long enough to know whether tamoxifen’s benefit is lasting. This trial can’t answer that question, either.
Many of the details of other benefits and risks of tamoxifen and raloxifene were not released by NCI. For example, we don’t know the specifics about how many women were able to avoid a bone fracture, how much both drugs increased the risk of stroke, and how many women died while they were part of the study."
This is the kind of analysis lacking in many news stories. Of course, for a look at how some media performed on this story, go to HealthNewsReview.org.
First day traffic to the new HealthNewsReview.org website was strong yesterday, with thousands of journalists and consumers visiting the site.
Public comment has been overwhelmingly positive.
Merrill Goozner of the Center for Science in the Public Interest wrote on his blog: "...I'm hoping a new effort by journalism professor Gary Schwitzer of the University of Minnesota has some impact on the profession. ... He's deployed several graduate students to monitor stories in dozens of newspapers and broadcasts and grade them with one to five stars -- just like the movies! By hacking around his website for a few minutes, I quickly discovered that the grades were based on solid, objective evaluation criteria. Any reporter looking to see why their work earned a poor rating could learn a lot by delving into the details of the critique.
Schwitzer, a former journalist who works closely with the Association of Health Care Journalists, goes to great lengths to explain that he isn't trying to belittle the reporters whose work is highlighted (I saw at least one got five stars). "We hope that U.S. journalists find our reviews helpful and accept the constructive criticism," he writes. "This project is intended to support excellence in health and medical journalism."
I wish him well in his efforts. Health care journalism has to get off the dead end track of reporting the latest study du jour, which is a one-way ticket to flacking for the drug industry. If there are any reporters reading this blog, I encourage you to check out his site. It's got a lot to offer."
I’m proud to unveil a project I’ve been working on for 8 months. Please visit HealthNewsReview.org to see a new attempt to help improve health journalism in the U.S.
A team of more than 20 reviewers from journalism, medicine, public health and health services research will evaluate and grade health news stories that include claims of efficacy or safety about treatments or procedures in health care.
An Associated Press story on the launch today quotes one observer saying she hopes the site doesn’t "end up being another media-bashing exercise." This website is not about media-bashing. It is quite the opposite: it is about supporting excellence in health/medical journalism.
We hope that journalists and consumers will use HealthNewsReview.org each day to help improve critical thinking and scrutiny of new ideas in health care. And we welcome your feedback.
Australian journalist Ray Moynihan and Professor David Henry are the guest editors of the April 2006 theme issue of PLoS Medicine on disease mongering. They also just hosted an international conference on the topic.
They write: "In our view, disease mongering is the selling of sickness that widens the boundaries of illness and grows the markets for those who sell and deliver treatments. It is exemplified most explicitly by many pharmaceutical industry–funded disease-awareness campaigns—more often designed to sell drugs than to illuminate or to inform or educate about the prevention of illness or the maintenance of health. In this theme issue and elsewhere, observers have described different forms of disease mongering: aspects of ordinary life, such as menopause, being medicalised; mild problems portrayed as serious illnesses, as has occurred in the drug-company-sponsored promotion of irritable bowel syndrome and risk factors, such as high cholesterol and osteoporosis, being framed as diseases."
PLoS Medicine is publishing several other articles on disease-mongering in the new special issue. Go to their website to see all of them.
PLEASE NOTE: disease-mongering will be one of the things we look for in a new U.S. website that evaluates and grades U.S. health news coverage. The site will debut next Monday, April 17. It is http://www.HealthNewsReview.org. More details later.
Here's more followup to the Center for Media & Democracy's report on the use of Video News Releases last week.
The LA Daily News picked up the story and reported that one of the culprit TV stations found to use VNRs is in that second biggest TV market in the country - KABC.
They reported: "Last September, Channel 7, the ABC affiliate for Los Angeles, aired a story during the 5 p.m. Tuesday newscast about a blood test to find allergies in kids. It looked like a legit news story, with interviews, graphics, cute kids and a voice-over by a Channel 7 news reporter. It wasn't, though. The report was a canned video news release, or VNR, produced for and paid by Quest Diagnostics, a company that runs labs around the country that do this very sort of testing. There was no disclosure by the station that the piece was an advertorial."
KCBS and KTLA in Los Angeles were also found to run VNRs without disclosing it.
In all, the report found 36 VNRs airing on 77 stations all over the country, and every newspaper in those cities should be telling the story, as the LA Daily News did.
At the same time that the FDA appears headed toward approving the obesity drug Xenical (orlistat) as an over-the-counter drug, the group Public Citizen has petitioned for a ban of even the prescription version of the drug.
Public Citizen today claims the drug has been known to cause a significant increase in a precursor to colon cancer. Last week, the FDA sent an “approvable” letter concerning the over-the-counter (OTC) version of orlistat to GlaxoSmithKline, which has applied to market this version. If the drug company meets certain conditions set by the FDA, the drug would probably be approved for OTC sales
“The failure to ban the prescription version of this drug or, worse, to make it much more widely available by allowing OTC sales, is a decision that is likely to increase cancer incidence,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group.
“The FDA should not allow a drug … to remain on the market for the long-term treatment of a non-lethal condition when it combines so little efficacy coupled with a still unresolved potential to cause breast and colon cancer,” says the 12-page petition. “[The] FDA is now considering increasing the number of people exposed to the drug by allowing OTC use. There is no scientific justification for this decision.”
The Chicago Tribune reports: "Scientists visiting Washington recently for a cancer research conference rode buses featuring slogans such as 'scientists on the road to conquering cancer.' But whether they can make that conquest by 2015--as claimed by President Bush's nominee to head the Food and Drug Administration--is a question roiling researchers and patients."
Acting FDA commissioner Dr. Andrew von Eschenbach was director of the National Cancer Institute in 2003 when he set a public goal of eliminating death and suffering from cancer by 2015.
The Trib states, "Many prominent researchers say the goal is a gimmick that gives patients false hope and distorts scientific reality. Nobel laureate David Baltimore, president of California Institute of Technology, said most of his colleagues are highly skeptical. 'I don't think people took it seriously because it was such an obviously unattainable goal,' Baltimore said. 'I was surprised, and I know lots of other people were surprised, that he chose a time so near, when we see it as a very difficult problem.' "
President Nixon declared war on cancer 35 years ago. Then it may have been a good way to deflect attention from the war in Vietnam. Could there be a parallel today?
The Star Tribune reports that UnitedHealth told the Securities & Exchange Commission it had created a panel to review how stock options are awarded to its top executives.
The paper lists some of the details of the SEC filing:
"William McGuire, Chairman and CEO
Total compensation: $10,697,442 for the year ended Dec. 31.
Salary: $2,200,000
Bonus: $5,808,000
Other compensation: $692,442
Long-term incentive pay: $1,997,000
Exercised stock options: $0
New stock options: 1,700,000
Had he retired on Dec. 31, his supplemental annual retirement benefit would be about $5,092,000 and his lump-sum payout would be $6,442,000.
Also disclosed in the proxy was the compensation of former Northwest Airlines CEO Richard Anderson, who joined UnitedHealth on Nov. 1, 2004. Anderson got a salary and bonus in 2005 of $1.2 million, plus 165,000 new stock options."
The Center for Media and Democracy (CMD) published a new report, "Fake TV News: Widespread and Undisclosed."
It's the result of a ten month investigation by CMD into the use of corporate-funded video news releases or VNRs - or fake TV news -- on TV stations without disclosure. Viewers could believe that these fake reports are the result of independent news reporting by station reporters.
CMD filed a formal complaint with the FCC, calling for the 77 stations they caught airing fake TV news to be held accountable.
Health news is a lucrative market for those who package and peddle these fake news VNRs. Examples in this study included VNRs touting a newly-approved prescription skin cream and one heralding a "major health breakthrough" for arthritis sufferers—a supplement that a widely-reported government study had found to be little better than a placebo.
That's what U.S. Representative Rahm Emanuel of Illinois, chairman of the Democratic Congressional Campaign Committee, said yesterday in response to the President's visit to Connecticut to promote health savings accounts.
Sounds like a new slogan for the upcoming mid-term elections. Or maybe it's an old one I've just missed. But until this recent push for health savings accounts, it's been easy to miss meaningful discussion of health care reform from this Administration. Now the President is riding health savings accounts as far as he can.
The New York Times reports: "The White House has been pushing the plan all week, putting the president on domestic policy ground far from the war in Iraq, though officials said tackling health care costs was a main presidential priority."
Then where was all this priority talk in the 2004 election?
There's a billion dollar battle looming over generic versions of statin drugs.
Newhouse News Service reports that "Merck's Zocor, the No. 2 cholesterol-lowering medicine, loses its patent protection in June, opening the door for inexpensive generic copies that could ultimately save consumers billions of dollars."
"We are sitting on a monumental change that's about to occur," George Paz, chief executive of the pharmacy benefit management company Express Scripts, says in the Newhouse story. "That is going to be a significant opportunity for our members and our patients, our clients, to save money."
The story continues: "A 10-milligram tablet of the most popular brand-name cholesterol fighters, including Lipitor, Crestor and Vytorin, usually costs more than $2, while generic Zocor, or simvastatin, is expected to cost about 35 cents.
To stave off what could be mass defections to generic Zocor, most of the big players in the cholesterol market - Pfizer, Schering-Plough, AstraZeneca and even Merck - have mobilized armies of sales reps to visit cardiologists, attend medical conventions and flood doctors' offices with free samples."
That's one huge advantage the brand names have over the generics. What's the last time a physician opened his/her drawer to give you a sample and handed you a generic?
But Newhouse reports that the future will be even more interesting: "The drama surrounding Zocor may be just a preview of things to come. Nearly 70 branded drugs with annual U.S. sales of $46 billion - including 19 blockbusters with annual sales over $1 billion each - are set to go off patent by 2010. Once a generic version goes on the market, it typically cuts the brand-name's sales by 80 percent within the first year."
Terri Schiavo's struggle brought much attention to living wills. But how did Americans act based on all of that attention?
A column in USA Today suggests that millions of Americans may have sought more information about such advance directives after the Schiavo story. But the story also suggests that many people haven't executed the directives, while others have filled out the paperwork but then didn't let loved ones or caregivers know about it, or didn't talk about it with people who need to know.
That certainly diminishes the chances that one's wishes will be followed in the last days of life. And other research suggests that even people who have done everything correctly in executing directives might not have their wishes followed in a crisis.
Finally, although it's not part of the article, you could raise many questions about what kind of education most people receive about what to put in an advance directive. Do they know the terminology? Do they know the actual scenarios that might arise? Have they addressed those scenarios properly? Do they put meaningless directives in writing?
As the article suggests, the problem of proper living wills and advance directives is far from solved.
The Wall Street Journal profiles Allan Hubbard, the President's college buddy who is also now the President's point man on health care reform.
His big push is for health savings accounts, in an attempt, the Journal says, to "make health care work more like a market, with well-informed consumers shopping for the best deals."
Princeton economist Uwe Reinhardt thinks Hubbard's ideas are overly simplified. Reinhardt told the Journal that he's reminded of President Clinton's health care guru, Ira Magaziner, who also treated complex problems as if they were simple.
So the Journal turned to Magaziner, who said that more price transparency would help, but health care will never be like other markets. "If you try to make it a pure market, the younger and healthy are the ones who benefit," he says. "That's not the way to run a society."
Hubbard is quoted saying, "When you ask the American people what's the biggest problem facing our country, at the top will be terrorism in Iraq, but the number-one domestic issue will be health care."
Too bad it didn't get that kind of attention in the last election.
Some readers were quick to catch the April Fool's prank behind the BMJ story about extreme laziness now being categorized as a disease.
The facts are that Professor David Henry of the University of Newcastle in Australia is hosting a conference on disease-mongering this month. And as the University announced earlier, "Professor Henry outlines a scenario that will form the basis of an educational exercise. He has created a new ‘disease’ – Motivational Deficiency Disorder (MoDeD), a previously unknown, but surprisingly common condition. Professor Henry says Professor Leth Argos will present data on the prevalence, social impact and treatment of this exhausting new disorder. 'Linked with this, a public relations company will demonstrate how a disease is ‘managed’, how it is promoted into the community and will explain all the steps and techniques involved in this process,' he says."