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According to an article in today’s edition of The New York Times, psychiatrists say they have been getting panicked phone calls from patients worried by an FDA advisory panel’s recommendation this month that drugs for attention-deficit disorder carry a prominent warning about heart risks.
Can you say “unintended consequences?”
The calls are coming not just from parents of children who take the drugs but from adult users, who the panel warned might be at the highest risk for heart problems.
Can you say, “irresponsible advisory committee causing increased non-compliance?”
“Every single adult patient I saw today, the first thing out of their mouth was, ‘Am I going to drop dead on this?’ Every single one of them,” said Dr. Timothy Wilens, a psychiatrist at Massachusetts General Hospital in Boston.
Can you say “fear replacing caution?”
Can you say “Precautionary Principle?”
Because if you can’t say it, you can’t fight against it.
And fight against it we must.
The just completed WHO meeting on counterfeit prescription medicines is over. And what took place in Rome should have a chilling effect on us all.
Consider these few facts (direct from WHO, so nobody can say they’re “industry” numbers) —
Between 1998 and 2004 there has been a 1000% increase in seizures of counterfeit prescription drugs
That is not a typo. A 1000% increase.
Between 2001 and 2004 there were 170 official cases of counterfeit medicines originating from an illegitimate supply chain
And most frightening …
Between 2001 and 2004 there were 27 official cases of counterfeit medicines that originated from the legitimate supply chain.
Sound frightening? It is.
Action is required.
While some in the US still don’t believe that counterfeit prescription drugs are a real problem (“Show me the dead Canadians!”) Europe is taking it dead serious.
On Wednesday, the Center for Medicines in the Public Interest (home to this blog) and the Brussels-based Centre for the New Europe co-sponsored a conference titled, “A False Sense of Security — The Growing Threat of Counterfeit Prescription Products.”
Shortly I will post all of the presentations from that event. A book will follow.
The next day (last Thursday) the World Health Organisation and the international pharmaceutical industry launched a global taskforce aimed at stemming “the growing epidemic” of counterfeit drugs that has become a magnet for organized crime.
Here’s what the Financial Times wrote on the subject …
On some estimates, fake drugs account for more than 10 per cent of the medicines market worldwide, worth nearly 40bn US dollars (34bn euros, 23bn pounds) a year. But in developing countries that proportion is more like 25 per cent and in some countries it may be as high as 50 per cent.
Howard Zucker, WHO’s top official on pharmaceuticals, said: “People donç©° die from carrying a fake handbag or wearing a fake t-shirt. They can die from taking a counterfeit medicine.”
The taskforce will focus on strengthening national laws and enforcement, raising awareness by consumers and health professionals, improving international co-operation and developing “innovative technology solutions” including electronic tagging to track fakes.
However, WHO is no longer pressing for work to start on an international treaty to tackle counterfeit medicines, which critics feared could simply serve as an excuse for delay and inaction.
“Clearly what’s needed here is action and we don’t need a convention to take some action,” said Harvey Bale, director general of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), which is co-sponsoring the Rome conference.
The Centre for Medicines in the Public Interest has predicted that counterfeit drug sales could nearly double to $75bn by 2010. While the problem is worst in poor countries with weak regulation and enforcement, where counterfeiters fake medicines for life-threatening diseases such as malaria, tuberculosis and Aids, much of the growth is fuelled by internet sales into western markets.Counterfeiters are now focusing not just on “lifestyle” drugs such as hormones and remedies for erectile dysfunction, but also expensive treatments for cancer and drugs in high demand, most recently the anti-viral Tamiflu.
The absence of criminal laws against counterfeiting in many countries has encouraged organised crime rings to enter the business.
“Organised crime is gravitating towards the industry because the risks are a lot less than forging currencies or trafficking heroin,” said Mr Bale. “You can make a fortune, at no risk.”
Dr Zucker said: “International police action against the factories and distribution networks should be as uncompromising as that applied to the pursuit of narcotic smuggling.”
WHO said it planned to extend to more regions a web-based system for tracking the activities of drug counterfeiters it set up last year to link national health authorities and other agencies in the western
Pacific.
As I arrived back in the US my mobile phone rang. It was a radio station in South Korea wanting to interview me on the fact that North Korea is now in the business of counterfeiting prescription drugs for profit. The world is paying attention. So must we.
It’s time for US regulators to join this working group and address the problem from a truly transatlantic perspective.
The lives we save may be our own.
Rep. Gil Gutknecht (R-Minn) and Rep. Rahm Emanuel (D-Ill.), the dumb and dumber of Congressional voices calling for drug importation, demanded an explanation on Wednesday for increased government seizures of drugs mailed to U.S. customers by Canadian pharmacies.
They don’t want an explanation — because they know the answer — uninspected, unregulated foreign drugs are unsafe and illegal. This is a recording.
“We believe this unannounced policy of increased enforcement is irresponsible,” the two said in a letter to the Food and Drug Administration and to U.S. Customs and Border Protection.
“There is a growing chorus of outraged Americans concerned that access to affordable prescription drugs is being denied to them,” reads the letter.
It is a chorus of two backed up by a supportive media echo chamber. But the music is out of tune and increasingly out of touch.
Here’s what these two elected representatives of the people are complaining about — recently the FDA launched an investigation confiscating thousands of drug shipments headed for the U.S. Some of them were headed for Minnesotans who ordered them over the state’s Web site. When opened, nearly half claimed to be of Canadian origin but, according to FDA investigators, 85 percent of them were from 27 other countries such as China, Iran, and Ecuador. And 30 of the drugs were counterfeit.
Why did FDA do what they did? Because it’s their job and it’s the right thing to do.
This is a recording. If you are looking for media attention, please leave your name and congressional district at the sound of the beep.
Bob Goldberg on the price-tag for survival …
It is both remarkable and tragic that at a time when we are finally winning the war against cancer, actually reducing the numbers of deaths due to that dreaded disease, the New York Times is editorializing against the value and use of the very medicines that have made such advances possible. Do we really need enemy combatants against medical progress?
The NYT claimed recently that Avastin at a retail price of $8000 for a month of treatment is too expensive for an average of 6 months of more life, without pain or toxic side effects for cancer patients that have not responded to other forms of cancer care. Here’s how I would have put the question: Is it worth having your insurance company pay about $5000 to keep you alive for 6 months or longer? What’s it worth to have drugs like Avastin around to keep tens of thousands of cancer patients alive longer and longer so they can live free of caregivers, can go to work, parent their kids, etc? The Times never asks that question.
Similarly, medical journals are now abandoning real science and are simply becoming collections of editorials by Monday morning quarterbacks. Most recent is the assault on the right of multiple sclerosis patients to use Tysabri to treat the devastating relapses associated with the disease. The British Medical Journal published “Lessons for Clinical Trials from Natalizumab in Multiple Sclerosis” by Abhlijt Chaudhuri, a physician known for believing that no drug for MS should be used without any rebuttal.
Unfortunately, his “lesson” seems to “grin and bear it.” Not acceptable.
The term ‘relapse’ sounds innocuous. It means losing balance, one’s sense of taste, eyesight, memory, etc. without warning. It can make walking impossible. The attack on Tysabri is simply an old saw applied to a new drug: since the drug doesn’t actually stop MS from progressing the possible long term safety problems aren’t worth the risk of returning to market. The article spews the same accusations made of every drug that is experimental: we don’t know what the optimal dose should be and how long people should take it. The fact that only clinical experience can help answer that question is ignored in favor of a standard of evidence that, if applied to the early release of penicillin, the measles vaccine, HIV drugs, and other breakthroughs, would have cost millions of lives.
That is like saying that since some drugs don’t cure a disease, don’t make them available at all. Again, the value of these medicines to people and their ability to give them back lives of productivity, dignity and independence means nothing.
Read More & Comment...On 2/4, blogging on a report that there was a backlog of generic drug applications at the FDA, I suggested that the agency seriously consider user-fees for this important area of responsibility. And it looks like that’s going to happen.
Scott Gottlieb, the FDA’s feisty and forward-looking deputy commissioner for medical and scientific affairs plans to tell the generic drug industry today that it is time for the government to charge its member companies fees so the agency can hire more staff and exprdite the processing of applications to market new generic medications.
In a speech he is scheduled to deliver to the Generic Pharmaceuticals Association in Florida, Gottlieb plans to say that user fees — like those paid by the makers of brand-name drugs, medical devices and animal drugs — are needed to keep up with generic reviews.
“From our perspective at FDA, we have seen user fee programs applied to our medical device and new drug programs with great success,” a copy of his speech says.
Gottlieb is scheduled to say in his speech that raising funds from generic-drug companies would allow the agency to review applications faster, to have more scientific data analyzing whether proposed new generics are equivalent to established brand-name drugs, and to address potential safety issues once the drugs are on the market.
Per Scott, “It’s not fair to compare our work in our generic drug office to our work in the new drug office, as some have done, without acknowledging that our new drugs program has benefited from funding tools that are not available to us when it comes to generic drugs.”
Use of generic drugs — which must be equivalent to the branded products that they duplicate — has been growing steadily, with more than 53 percent of prescriptions now filled with generics. That percentage could increase
quickly because an unprecedented number of major branded drugs will lose their patent protection in the next few years.
In addition to raising the user-fee issue, Gottlieb is set to outline a number of agency initiatives to speed generic reviews. One is a formal lifting of a ban on direct telephone conversations between FDA reviewers and generic drug makers. Another involves grouping bioequivalence review applications for the same or similar drugs.
You tell em Scott.
Talk about being a Nabob of Negativism! Families USA (the political lobbying group that masquerades as a “citizens advocate”) is downright gleeful in it’s grossly premature burial of Medicare Part D. According to its new report (a love note to the Intelligensia of Interference issued on Valentine’s Day) the Bush Administration has “significantly lowered” its enrollment projections for the new drug benefit.
Really? I don’t recall anyone from the White House saying that? Maybe Ron Pollack, the Families USA “Godfather,” meant White Castle? And I certainly didn’t hear Mark McClellan say anything remotely like that during his recent, highly publicized congressional testimony. And I didn’t read it in a Robert Pear column. So could it really be true?
No. I think that the Godfather must be hearing voices — and that those voices are “interfering” with his cognitive processes.
Giving a new and draconian meaning to “family-friendly,” Godfather Ron also concludes that a vast majority of those enrolled in Part D already had drug coverage before the benefit began and that only “a very small fraction” of beneficiaries eligible for the low-income subsidy have entered the program.
Methinks that the Godfather would like the truth to sleep with the fishes. This new report is just another example of reality non-interference.
I suppose that Families USA expected 100% sign-ups with zero problems after almost a month and a half! Can’t this administration do anything right!
Proving that they are most decidedly living in a Pelosi-induced fantasyland, Godfather Ron commented, “It’s truly disappointing to see such a large number of seniors not get the benefits to which they are entitled.” He further added that the drug benefit has so far “produced rather meager results.”
I guess he thinks that if he keeps saying that enough times people may actually start believing him.
CMS spokesman Gary Karr politely suggested that Families USA spend its time and energies more productively by helping to expand the number of seniors enrolled in Part D instead of taking “ill-informed partisan potshots.”
Good for you Gary.
Karr then said that CMS has not downgraded their enrollment estimates. “The numbers that [Families USA] cite come directly from us. We’ve been open and above board about exactly what those numbers are and where we get our estimate of the 28-to-30 million.” Families USA, citing a January 28, 2005 CMS Federal Register notice, said that the administration had been projecting that 39 million beneficiarieswould enroll.
But it’s the Godfather of Garbage and his “Family” who are doing the projecting. For them it’s all about political spin and vituperative spittle. Anything for the cause.
Read More & Comment...Well, isn’t this wonderful? The Wall Street Journal reports today that “… the G-8 nations [propose] to subsidize the purchase of new vaccines—-for between $800 million and $6 billion—-if pharmaceuticals companies develop ones that meet standards of efficacy and safety. Once the G-8 spends the pledged amount, the drug companies would sell the vaccine at a set discount in the developing world.”
So: Having damaged the vaccine sector seriously with a combination of price controls, regulatory hurdles, and absurd tort liabilities, the bureaucrats and politicians now propose to undo the damage using taxpayer resources, all the while, of course, congratulating themselves for their compassion. Well, how is it that the private sector ever produced vaccines at all? To say the same thing differently, we now are reaping the fruits of decades of destructive policies; now taxpayers will have to assume investment risks that the private sector is in a far better position to evaluate and bear. Moreover, the risk allocation issue is only the beginning; which vaccines will receive favor? The ones that offer the biggest health bang for the buck? Or the ones that are most favored among the politically corrrect? And will “profits,” however defined, be limited while losses are not? Will the various governments attempt to use profits from other investments implicitly to subsidize these favored vaccines? Etc. Just asking.
Read More & Comment...A recent inspection by the U.S. Food and Drug Administration found some of the drugs Minnesotans order from Canada may not be from the country at all.
Wallace Greenfield discovered one of his “Canadian” drugs came from Greece, and another came from Vanuatu, a small island in the South Pacific.
“I never heard of the place,” Greenfield said.
The U.S. government says it happens all the time and is a growing concern.
“We were beginning to see a pattern of products coming that were purporting to be of Canadian origin coming from various countries from throughout the world,” said Steve Niedelman of the FDA. “We wanted to determine how widespread this was.”
The FDA launched an investigation confiscating thousands of drug shipments headed for the U.S. Some of them were headed for Minnesotans who ordered them over the state’s Web site.
When opened, nearly half claimed to be of Canadian origin, but “85 percent of them were from 27 other countries,” Niedelman said.
“We saw product coming through from Germany, from Australia, from China, from Iran, from Ecuador,” Niedelman said.
The FDA said 30 drugs were counterfeit.
The Minnesota Senior Federation says 25 prescription orders from Minnesota were among those that were confiscated in recent months.
According to Tom Sheck of Minnesota Public Radio (a media never accused of slanting to the right), “When Gov. Pawlenty announced the MinnesotaRXConnect program two years ago, he predicted that it could cover 700,000 Minnesotans and save millions of dollars for consumers. The actual numbers are well short of those projections, and demand for the program has been declining sharply in recent months.”
It’s time for Governor Pawlenty to relenty and stop his unlawful, unsafe and (fortunately) seldomly used state-sponsored program.
Because today it’s just folly, but it could very well turn into state-sponsored health care terrorism.
During my tenure at the FDA I was the senior official in charge of advisory committees. I was proud to oversee a transparent, collegial, and scientific program crucial to the agency’s mission of protecting and advancing the public health.
Today I am upset and worried about the future of this process.
In the wake of FDA bashing for political and personal gain, the advisory committee process is spinning out of control. Witness yesterday’s unexpected chest thumping by members of the Drug Safety and Risk Management advisory committee
The panel voted 8 to 7 to propose a ‘black box’ warning for methylphenidate drugs, sold under the brand names Ritalin, Concerta, Methylin and Metadate, and on the amphetamines Adderall and Adderall XR, stimulants used to treat attention deficit hyperactivity disorder. The warnings could be rescinded if future studies fail to definitely establish any risk.
But the harm to physicians (worried about law suits) and parents (worried about their children), and the children (who aren’t being appropriately treated) would have already happened. What makes this so very frustrating is that the committee didn’t make its recommendation for a black box based on the available data, members of the board said the recommendation was driven as much by worries that the drugs are being overused in the United States as by the possible side effects.
The FDA advisory committee process in the Age of Grassley seems to be “Science? We don’t need no stinking science.”
And even more frightening is Precautionary Principle creep.
According to the Associated Press, “The surprise recommendation has caught the Food and Drug Administration off guard.”
To say the least.
“You don’t want to overscare people with data that aren’t very solid,” said Robert Temple, director of the FDA’s office of medical policy. He said the drugs carry real benefit for some patients. Before the committee’s vote, Thomas Laughren, who heads the FDA’s division of psychiatric drugs, told the committee he didn’t “think we are there yet with this cardiovascular risk” in terms of justifying a black box.
Science? We don’t need no stinking science.
Here’s a headline from a story by Marla Cone in today’s Los Angeles Times …
“Mercury readings high in state.”
Here’s the lead paragraph:
“Californians have among the worst mercury contamination in the nation, with nearly one-third of those volunteering in a nationwide study exceeding the concentration of the potent neurotoxin deemed safe, according to a study organized by two national environmental groups.”
Here’s the 10th paragraph (of an 11 paragraph story):
“The new study, which is ongoing, is the largest test of mercury exposure in the nation. But the results are not statistically representative of the United States because participants were self-selected volunteers. They joined the study by visiting the Greenpeace or Sierra Club Web sites and sending $25 with each hair sample.”
Sloppy, slanted, spurious reporting.
Please pass the tuna.
I’m sure that Senator Charles Grassley and others who think the FDA should view the pharmaceutical industry in a strictly one-dimensional adversarial fashion will be upset to learn that collegial two-way communications is — gasp — good for the public health.
According to a new report, new medicines reach the U.S. market sooner when regulators meet with drug makers before the final phase of human testing and made sure they were addressing potential pitfalls. The report, by consulting firm Booz Allen Hamilton (undertaken at the request of the FDA), said fifty-two percent of manufacturers that consulted the Food and Drug Administration at that time won approval after an initial review, according to an analysis of 77 drug applications submitted from 2002 to 2004. Only 29 percent of companies that did not have such meetings received clearance for their products during the original cycle. (Medicines that fail to win FDA clearance after the original review of typically six to 10 months may go through multiple evaluations before reaching the market.)
A top FDA official said the agency agreed the early meetings with drug makers were productive but said more staff would be needed if the number increased substantially. (This is code for “we need more money!”)
“We have seen a pretty dramatic growth in the number of meetings we’re having with sponsors in the past several years. Any additional workload for meetings is going to have to be supported by additional staffing,” said Dr. John Jenkins, director of the FDA’s Office of New Drugs.
“Early and open communication with the sponsors will allow sponsors to address/resolve issues in a timely manner, potentially within the first review cycle,” the report said.
Once more with feeling everybody, let’s do the budget season chant — “Show me the money!”
Read More & Comment...Dr. Bob Goldberg pulls no punches in response to Stephanie Saul’s article (“Record Sales of Sleeping Pills Are Causing Worries”) in today’s edition of the New York Times …
Stephanie Saul fits the mold of NY Times reporting on the drug industry like a glove: Big bad companies market lifestyle meds with horrible side effects when simple changes in how we live could easily take care of the problem. Instead of marketing erectile dysfunction drugs, the drug companies are pushing sleeping pills of all things.
Here’s the crux of her article, “… some experts worry that the drugs are being oversubscribed without enough regard to known, if rare, side effects or the implications of long-term use. And they fear doctors may be ignoring other conditions, like depression, that might be the cause of sleeplessness.”
Rare side effects and implications of long-term use? What are the side effects? Sleepiness? That is fairly standard and well known. How do we know they are being over “subscribed?” Saul gives us no benchmark since there is nothing in the article about the extent of sleeping disorders in the United States. Along those line, her claim that experts fear doctors are ignoring related conditions flies in the face of a campaign to make doctors aware that sleep disorders are a component of other illnesses. If she had done a little research, just five minutes of Googling, she could have found that out.
But she doesn’t give us context because Saul wants us to believe sleeplessness was a problem invented by drug companies to sell a useless product. Has she read anything about the increased risk for stroke and sleep apnea? What about the studies reporting up to 80 percent of people on dialysis suffer from insomnia? The fact that most primary care doctors have failed to treat sleeping disorders among people suffering from mental illness, arthritis and fibromyalgia?
A good article would have provided context, history, risks and benefits. As it stands, it is another example of the rotting standards of medical journalism that dwells on the fear factor.
FDA released its Fiscal Year 2007 budget request to Congress totaling $1.95 billion, a 3.8 percent increase over FY 2006.
Nearly $6,000,000 ($5,940,000 to be precise) is new funding for the Critical Path Initiative. This is the first time Critical Path funding has been included in the Administration’s proposed budget.
It’s money well spent and I certainly hope members of Congress embrace this as an important initial investment in the future of American health care.
An initial investment.
In a notice posted on the FDA’s Web site Friday, the agency said it is seeking comments on a proposed study that would examine whether coupons and rebates that are part of some prescription-drug advertisements might cause consumers to think a drug is safer or more effective than it really is. The agency said the study is part of an effort to get “empirical data about consumers’ perceptions” of coupons and how a particular product might be viewed. The agency said information from the study would be used “to justify future regulatory changes.” “Coupons and price promotions may imply superior drug efficacy,” the FDA said.
Well, here’s a cost-saving tip to my buds at DDMAC — coupons do, in fact, attract people to a product. That’s why they’re used. Whether or not an ethical product should coupon is certainly an interesting philosophical question.
But it is in no way a regulatory one.
Here’s Bob Goldberg’s perspective on another aspect of Marc Kaufman’s article …
So typical of the lazy and unsystematic thinking that plagues health care reporting in general. Worrying about generic drug backlog because it’s one of the few ways to reduce “skyrocketing” health care costs” (Actually, health care costs have been slowing in recent years but whose counting. Increased use of medicines is attributed by many scholars — i.e., not journalists — for the slowdown because use of medicines postpones or offsets utilization of surgery, nursing homes, etc.)
Now, how about the delay in the cervical cancer and rotavirus vaccines? The delay in the Alzheimer’s vaccine? The 10-year lag in figuring out that Herceptin should be used in early stage breast cancer because all the trial designs are geared to show maximum benefit from a frequentist statistical standpoint that has no reference to real world use? Taken together these products and uses alone would make the “savings” of the 800 generic medicines waiting at FDA seem a pittance. Has Kaufman ever done a piece on the need or effort to transform the FDA to accelerate the development of real health care solutions. No. You can look it up.
It’s another example of how the MSM fails to get the connection between health care costs and technology: the price of new technologies that are based on a geniune understanding of disease mechanisms and individual responses to treatment are cheap relative to the cost of managing the same illnesses with halfway or no tech approaches. Put another way: what is cheaper, what is more cost-effective: using generic versions of today’s drugs as part of the effort to treat more cases Alzheimer’s, cancer, stroke, diabetes using our current know-how, or treatments that actually prevent or stop these diseases before they develop?
Why do policymakers, pundits and journalists see the efforts and investments of companies pursuing these high tech solutions are evil but see the accelerated development of knock-offs as holy?
In The Washington Post, Marc Kaufman reports that the FDA has a backlog of more than 800 applications to bring new generic products to the market — an all-time high.
FDA, however, has told Congress that the office that reviews new generics needs no additional money, and the agency has no plans to hire more reviewers. “We are very aware that many, many people are waiting for more generics to be approved and that there is frustration about the backlog,” said Gary Buehler, director of the agency’s Office of Generic Drugs.
That generic response is completely unacceptable. The Office of Generic Drugs needs more reviewers and that means it needs more money.
The days of saying “we can do more with less” are over at the FDA. Today, unfortunately, it’s about doing less with less. That is not acceptable.
The generics office’s budget was about $26 million last year. In response to questions from Congress, the agency said the generics program would have to make cuts in 2006 to offset pay raises. Gary Buehler said he expects a record number of applications this year — and an even larger backlog — because “we don’t believe we’ll be getting any staff increases in 2006.” Buehler said his office received an all-time monthly high of 129 applications in December.
And he says he doesn’t need any more money?
“This huge backlog of generic applications is just unacceptable,” said Rep. Henry A. Waxman, one of the sponsors of the law that made generics more easily available two decades ago. “This is the time for the FDA to be ramping up its generic reviews, not to be falling so badly behind.”
I never thought I’d be saying this, but Mr. Waxman is 100% right. But talk is cheap. The question is, what’s he going to do about it?
Henry — show me the money.
Some at the agency and in the industry say the answer is to have generic-drug makers do what brand-name makers did in the early 1990s — pay user fees to finance new hires by the FDA.
Considering the huge profits enjoyed by the generic drug industry, I think this is certainly something to consider.
Plan “B” for “Bob” (Goldberg) …
Fresh from rolling her eyes at the President at the SOTU, Hillary Clinton took direct aim at CMS director Mark McClellan about the what the media has now deemed “the troubled” Medicare prescription drug plan. In full campaign mode, Mrs. Clinton told Dr. McClellan during a hearing “I, for one, believe we should scrap this and start over.”
With what? Hillary didn’t say. But she’s still proud of her record so we can assume that Plan B is Hillarycare Redux. Indeed, after trashing McClellan she took the opportunity to take credit for drug prices going down when she was running the health care show. “We weren’t successful getting the legislation passed, but we were successful sending a message that people better get their prices down,” she said.
Maybe. But back then the market value of biotech stocks also went down. So too did the amount of venture capital flowing into start-ups. Indeed, the amount of money going into biotech declined more sharply when Hillary was threatening price controls than at any other time since biotech has been around. A survey of biotech firms at the time and found that 75 percent of them had 2 years of cash or left in large part because, as the head of the biotech trade group BIO testified at the time “1993 difficult year because in large part investors were scared by the de facto price controls in the Administration’s health care plan. They feared that some widely discussed points of health care reform would mean that they would not recoup their investment in a company that was close to bringing a product to market. According to many press accounts and three BIO surveys of our companies developing therapies for AIDS, cancer, and other deadly and costly diseases, our companies are cutting back on research.”
And the price controls she DID get passed in the Vaccines for Children Program were cited by the Institute of Medicine in 2001 as one reason the vaccine industry is stagnant and unprofitable. Who wants to invest in products knowing your prices are going to be frozen for a decade?
Then there’s Children’s Health Care Insurance Plan she loves to take credit for. This program provides federal money to set up state run low cost insurance programs for working class kids. It was supposed to insure nearly 9 million children. Guess what? Under her stewardship kids were first dumped from Medicaid and then re-enrolled into SCHIP programs. And then it took 4 years to enroll 3 million children. And at the same time, private companies dumped coverage for kids and many parents simply stopped insuring their kids at all.
This page will be more than happy to help Mrs. Clinton promote her health care ideas. Sunshine is the best disinfectant.
Here’s an e-mail that Michael Moore is sending around. (I’ve only included snippets — but you’ll get the idea.) It’s just another high profile example of the Propaganda of Fear, of finding horror stories and packaging them to look like the everyman status quo. The epitome of the one-sided argument. If this project ever sees the light of day, it will have an impact on some of our political leaders — because it’s precisely the kind of drivel they want to hear. It’s the 21st century version of bread and circuses.
That being said, it’s time that we begin our own crusade of good news, of communicating, through truth and hope, the miracles of modern medicine. We must fight the Propaganda of Fear with the Four Horsemen of Conviction, Confidence, Truth and Hope.
Here’s the less from Moore …
Have you ever found yourself getting ready to file for bankruptcy because you can’t pay your kid’s hospital bill, and then you say to yourself, “Boy, I sure would like to be in Michael Moore’s health care movie!”?
Or, after being turned down for the third time by your HMO for an operation they should be paying for, do you ever think to yourself, “Now THIS travesty should be in that ‘Sicko”movie!”?
Or maybe you’ve just been told that your father is going to have to just, well, die because he can” afford the drugs he needs to get better — and it’s then that you say, “Damn, what did I do with Michael Moore’s home number?”!
Send me a short, factual account of what has happened to you — and what IS happening to you right now if you have been unable to get the health care you need. Send it to michael@michaelmoore.com. I will read every single one of them (even if I can’t respond to or help everyone, I will be able to bring to light a few of your stories).
Thank you in advance for sharing them with me and trusting me to try and do something about a very corrupt system that simply has to go.
It’s time that we, the voices of reason and sanity and hope go on the offensive against people like this who, just to turn a buck, will ravage just about anything — including the miracles of modern medicine. Mr. Moore isn’t interested in making things better — but he’s sure interested in making money — the same charges he’s leveling against those in the crosshairs of his camera lens.
Long-term thinking at long last in European health policy? Maybe.
European governments seem to be swapping a bludgeon for a scalpel when it comes to cutting the cost of medicines. According to Reuters, drug makers should not expect an end to the overall drive to squeeze prices but there are signs of a more discriminating approach that may actually help “big pharma”, according to industry executives and analysts. Andrew Witty, head of European pharmaceuticals at GlaxoSmithKline Plc said a growing number of governments are now realizing that healthcare reforms must include rewards for innovation.
“There are still a few governments that are very focused on short-term, non-discriminatory cost measures, where they simply cut prices and they donç©° really care if it is an innovative product or an old one, but they are getting fewer,” he told Reuters. ‘There are more and more countries where we are seeing governments get much tougher on the prices of old, off-patent medicines and being prepared to reward meaningful innovation more quickly and more fully.” For companies like Glaxo, which relies heavily on sales of newer drugs, that is good news.
European pharmaceuticals growth is hovering around a 10-year low with sales in the top five markets — Germany, France, Britain, Italy and Spain — rising just 3% in the 12 months to November, according to IMS Health. Yet Merrill Lynch believes the worst effects of European pricing reforms may now be over, with Germany in particular showing signs of recovery. Growth in German pharmaceuticals has picked up to 7%, from 1% in 2004, largely as a result of a cut in mandatory manufacturer rebates to the government, the investment bank said in a report this month.
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