Our dysfunctional FDA

You know things are bad with the Food and Drug Administration when even Europe is better at approving new life-saving drugs than the US FDA. In today's Wall Street Journal, former FDA commisioner Scott Gottlieb provides some details:

Europeans are now approving novel drugs an average of three months more rapidly than we do. Of 82 novel drugs that were submitted for approval in both the U.S. and Europe between 2006 to 2009, 11 were approved only in Europe. One is for relapsed ovarian cancer, another for bone cancer.

The FDA Modernization Act of 1997 gave the FDA discretion to speed up the approval process but the FDA rarely uses that authority, as Mr. Gottlieb reports:

Of 76 cancer drugs approved since 2005, the FDA gave only 13 "accelerated approval"—another process created under the Modernization Act to expedite drug development. From 2001 to 2003, 78% of the novel cancer drugs approved were granted accelerated approval. Since then only 32% got the designation.

Whether you regard that information as just statistics or as a tragedy depends on whether you have a loved one currently dying of cancer.

PREVIOUSLY on the subject of government regulation:
•I'm from the government and I am here to help you (video)
•Regulators use false science
•Regulators with the best of intentions
•Businessmen report government regulations and red tape slowing the economy
•Federal regulations responsible for raising health insurance premiums
•Obama Administration appears to want to use campaign finance regulations to silence opposition
•Regulators pressed banks to issue more and riskier loans
•FTC wants to regulate blogs
•Regulators and the mortgage loan crisis
•Obama Administration proposes politicizing financial regulations
•Democrats blocked financial regulation reform
•Who wants to be the last to die for a regulation
•Obamacare regulations may raise insurance costs by 54%

Obama wants to kill your mother!

President Obama has weighed in on health care for senior citizens:

President Obama suggested at a town hall event Wednesday night that one way to shave medical costs is to stop expensive and ultimately futile procedures performed on people who are about to die and don't stand to gain from the extra care.

In a nationally televised event at the White House, Obama said families need better information so they don't unthinkingly approve "additional tests or additional drugs that the evidence shows is not necessarily going to improve care."

He added: "Maybe you're better off not having the surgery, but taking the painkiller."

RELATED: Michelle Malkin notes that viewers turned away from ABC News' "unbiased" infomercial for ObamaCare and wonders "Who’s funding the Obamacare Astroturf campaign?"

PREVIOUSLY on the subject of government-run health care:
The Canadian health care collapse: 15 years of regress
The Flu and Federal Incoherence
Socialized medicine explained
Health care crisis faces threat. Democrats respond
Socialized medicine watch
Medical care and governmental control
HillaryCare will stop this: Canadian MP flies to US for treatment
In government we trust: Britons fly abroad for health care

The Flu and Federal Incoherence

Vice President Biden advises his family to stay off planes and subways due to the swine flu threat, as The Daily Voice reports:

Vice President Joe Biden said on Thursday that he would advise his own family not to travel on planes or subways during the current swine flu outbreak.

Speaking on NBC's Today Show, Biden said "I would tell members of my family, and I have, I wouldn't go anywhere in confined spaces places now." The vice president specifically mentioned airplanes and subways. if one person sneezes on a confined airplane, "it goes all the way through the aircraft," Biden said.

As for whether he would encourage his family to take public transportation, Biden said "I would not be at this point, if they had another way of transportation, suggesting they ride the subway." But Biden was quick to limit his remarks to his own family. "That's me," he said.

The White House quickly "clarified" Biden's remarks. For perspective, an American is, so far anyway, hundreds of times more likely to die in an Al Qaeda attack than to die after catching the swine flu in a subway.

Joe Biden is a heartbeat away from the presidency.

Contrast Joe Biden's approach with the Department of Homeland Security which is forbidding its employees from wearing protective masks:

The Department of Homeland Security said Thursday it has not told agents at U.S. airports and border checkpoints that they cannot wear masks to protect from exposure to swine flu.

They do allow for an exception:

"Masks should be used in high-risk situations, such as when an employee comes into contact with a person or traveler who appears to be ill," the official said..

"If an employee at (an airport) or (on the border) comes into contact with someone who appears to be ill, it is strongly recommended and encouraged that both of them put on masks and gloves immediately," the official continued, adding that "the safety of employees is of the utmost importance."

Asked why an agent shouldn't be allowed to wear a mask if it makes him or her more comfortable and doesn't affect performance, the official said only that "science indicates" masks are not needed now.

So, as thousands of travelers walk past them at customs, the agents have to wait until they are in contact with a person "who appears to ill." By that time, of course, it is likely too late in the exposure for a mask to matter.

So Biden advises his family not to take the subway but his government prohibits employees with constant exposure from wearing a mask? And, Democrats want the government to be put in charge of our health care decisions.

UPDATE: The federal confusion continues. On the one hand, the Obama administration denies the policy:

Department of Homeland Security spokesman Sean Smith vehemently denied that there is any official restriction on federal employees wearing face masks at points of entry.

On the other hand, the employees working there deny that denial and plead for their own safety:

In a statement issued late this morning, NTEU [National Treasury Employees Union] president Colleen M. Kelley said the [mask] instructions are inadequate and "putting at unnecessary risk the health of these employees, specifically those that are responsible for clearing travelers from Mexico, and those with special conditions such as pregnancy or respiratory ailments."

Unbalanced in Berkeley

Berkeley, California, is famous for its left-liberal politics. It is even a "nuclear free zone." So what is it like shopping in a Berkeley grocery store? The LA Times reports:

As most veteran customers know, it takes a pretty thick skin to successfully navigate the Berkeley Bowl, this strident city's most popular grocery store.

Outside, petitioners seeking signatures for ballot measures have come to blows with opinionated residents. In the tiny parking lot, nicknamed the Berkeley Brawl, frustrated motorists have been known to ram one another's cars. At the checkout, people have thrown punches and unripened avocados at suspected line-cutters.

When one shopper was told she couldn't return a bag of granola, she showily dumped its contents on the floor. Culyon Garrison, who works at the customer-service desk, recently had a loaf of bread thrown at him.

The produce emporium -- one of the nation's most renowned retailers of exotic fruits and vegetables -- creates its own bad behavior. Kamikaze shoppers crash down crowded aisles without eye contact or apology for fender-benders. ....

"There's a sense of entitlement to this town," [Store manager Larry] Evans said. "People think, 'If I want to do it, I'll do it, just try and stop me.' "

A "sense of entitlement"? That certainly explains much that is wrong with liberalism.

Mr. Evans also suggests anger issues, which would be consistent with what is known about Democrat psychology.

For an alternate opinion, see James Taranto who suggests that the cause is dietary.

Health food to die for

Kate Finn, a former gymnast from Rhode Island, developed an obsession with health food. (WARNING: this story does not have a happy ending.) As ABC News reports:

She was so absorbed with cleansing her body of toxins ... that was her lifelong goal," said Erin Finn, Kate's sister.

In the quest for purity, Finn eliminated more and more from her diet. Her appearance deteriorated. "The beautiful, vibrant Kate had really become someone that looked much older. People would stare," Erin Finn said.

Finn wasn't anorexic. Erin Finn said her sister knew she was underweight, but she insisted on eating only foods she considered "pure."

Like Charlotte Anderson, Kate Finn kept a diary documenting her desperate descent. One entry reads, "What do I do to gain weight? I'm afraid, confused."

Finally, Finn agreed to let her family take her to a hospital.

"Our niece went to pick her up," her sister said, "and found her."

But it was too late. She was discovered dead, at age 37.

The story gets stranger: one of her health food gurus, Viktoras Kulvinskas, considers her death to be some kind of new age-type victory:

As Finn's family read through her diary, they learned that she had been listening to several health food gurus. Among the experts: Viktoras Kulvinskas.

Kulvinskas's appearance in Finn's diary doesn't surprise him.

"I'm in the diary of so many people who overcome cancer, asthma and diabetes," he said. "My compassion reaches out to her that she took the path. Well, at least she got detoxified and clean, and moved on into another incarnation."

This story is something to remember the next time that some do-gooder tells you what to do to improve your health or your environment.

PREVIOUSLY, in this series on liberalism gone bad, see herbal medicines to die for, and auto regulations to die for.

Herbal medicines to die for

Dr. Robert Saper, a Boston University professor of family medicine, became interested in ancient Indian herbal medicines after someone showed up at his emergency room with seizures. As the LA Times reports:

Saper got interested in the supplements in 2003 after a man of Indian origin showed up at a Boston-area emergency room with seizures. The culprit turned out to be lead in the man's ayurvedic medicines. In an initial study published in 2004, Saper bought 70 ayurvedic products imported from India and found that toxic metals were common components.

According to the New Scientist, the levels of heavy metals in some Rasa Shastra medicines are far above the levels that the FDA permits in medicines over which it has regulatory control:

One sample of a preparation called Ekangvir Ras had 26,000 parts per million of lead. This compares with a US legal limit of 2 ppm in pharmaceutically produced calcium tablets for the elderly.

Kush Khanna, who manufactures such ayurvedic medicines, counters by citing World Health Organization rules. As the LA Times writes:

The problem is that there are no unified standards for what is considered safe.

Lead levels allowed by the World Health Organization are 500 times the California limits.

"Based on WHO standards, our products are perfect," Khanna said. "They have not exceeded any limits."

Dr. Saper counters that "Many, many studies are showing that even small levels of lead in the blood can increase the risk of high blood pressure, kidney dysfunction and decreased IQ." Mr. Khanna sells his heavy metal rich potions from the company his father started, Bazaar of India, located in Berkeley, CA.

Left wing activists oppose science violently

Two UC Santa Cruz scientists, who had been targeted by animal rights activists, were attacked with firebombs last week. One attack caused a fire at a Professor's house. Damage was limited because of his sprinkler system but, since the professor's family was inside the house at the time, the FBI classifies this attack as an attempted homicide. These attacks come after an attempted home invasion at another UCSC researcher's house last February. The FBI has suspects.

The left has had some success stopping science this way. For example, as the LA Times reports, "[i]n 2006, a UCLA neurobiology professor announced that he was stopping his primate research because of harassment and threats to his family."

PREVIOUS attempts by the left to stop science include (peaceful) opposition to research on the relationship between hormones and homosexual behavior
and attempts to stop research into the effects of affirmative action.

Mobile phones may be death sentence?

Are mobile phones "more dangerous than smoking or asbestos"? So says Dr Vini Khurana in a study currently being hyped. His claim is that there is a brain cancer risk for long-term, 10 years or more, use of cell phones. This would be important, if true. What is the status of this research? The Independent (UK) writes:

[A] paper based on the research is
currently being peer-reviewed for publication in a scientific journal.

In other words, his claims have not yet gotten through even the first stage of scientific validation. His calling of press conferences to scare the general public on something that has not survived peer review is irresponsible.

Statistical studies claiming to link some action to some disease should never be believed until confirmed by other studies. It is the nature of statistics, discussed in detail here, to go wrong occasionally. If there is a genuine link between 10-years of cell phone exposure and certain malignant brain tumors, it will start to show up consistently in future studies. At the moment, one study links cell phones to one awful disease and the next study links them to some other awful disease. This is exactly the statistical pattern that one would expect if there were no link at all.

Cell phone wrecks sleep, maybe

The Independent (UK) has a story running under the title "Mobile phone radiation wrecks your sleep." They write:

A massive study, following 1,656 Belgian teenagers for a year, found most of them used their phones after going to bed. It concluded that those who did this once a week were more than three times – and those who used them more often more than five times – as likely to be "very tired".

If we accept the Independent's description of the study at face value, this only says that frequently carrying on conversations after going to bed leads to being "very tired." To identify the cause as cell phone usage, the researchers needed to compare those who talk too much by wired phone to those who talk too much by wireless (cell) phone.

Full Faith and Credit in the Government

Jonathan Rees, of The Writing on the Wall, is upset that people like RediClinic for minor ailments:

Wal-Mart (or to be more exact, their sub-contractor) hasn’t solved the healthcare crisis. All they’ve done is given reluctant politicians less incentive to tackle the real problem: fixing the entire healthcare system for everyone....

If you believe in miracles, you believe that our politicians are brilliant and have the wisdom to fix the "entire healthcare system for everyone." (Some liberals envision government as the 'ideal parent' that they never had but who can solve all problems miraculously.) In the real world, government-run health-care systems at their best just substitute one set of problems, such as expense, with another, such as death by queue. People who are honestly concerned about affordable health-care should welcome the option of RediClinics and their competitors for fast, convenient, and inexpensive treatment of minor issues. Instead, Democrats such as Mayor Menino want to use force of law to ban them.

Health care crisis faces threat. Democrats respond

Wal Mart and other stores are opening convenient care clinics that allow quick, easy, and inexpensive access to nurse practitioners. Some people like the service. This has scared Democrats such as Boston Mayor Thomas M. Menino who, presumably because of the threat such clinics pose to the "health care crisis" rhetoric, wants to ban the clinics. Some physicians are concerned also:

They apparently are going to do everything I do, and for a cheaper cost, because NPs cost less than MDs. .... Peeved!? Yes, I am. They're infringing on my territory, .... [T]he American Academy of Family Physicians (AAFP) has signed an official agreement with the RediClinic for adhering with its "desired attributes of retail health clinics." Et tu, Brutus?

Change can be painful.

Hat tip: Instapundit.

In government, we trust, II

Over at DailyKos, Kos complains about the difficulty that he has had dealing with the massive bureaucracy at Blue Shield over paying an out-of-network anesthesiologist. As a liberal, he, of course, expects that huge government-run bureaucracies, like HillaryCare, would be friendlier. If the problem is a bureaucratic run-around, the solution would hardly seem to be a larger bureaucracy.

He asks "[h]ow could a government-run service be any worse than these unaccountable, unethical, disgusting creeps?" Well, for one, he didn't have to leave the country to get care. Also, they didn't poison him. Yes, government-run systems can be worse.

In government we trust

HillaryCare update from the UK Telegraph:

Record numbers of Britons are flying abroad for medical treatment to escape NHS waiting lists and the rising threat of hospital superbugs.

Thousands of "health tourists" are going as far as India, Malaysia and South Africa for major operations – such is their despair over the quality of health services.

The first survey of Britons opting for treatment overseas shows that fears of hospital infections and frustration with NHS waiting lists are fuelling the increasing trend.

More than 70,000 Britons will have treatment abroad this year – a figure that is forecast to rise to almost 200,000 by the end of the decade.

Hat tip Bookworm Room.

HillaryCare will stop this

Belinda Stronach, a Canadian MP and a supporter of Canada's socialized medicine, flew to the US for treatment.

Those talking points need to be double-checked

Mark Bellis performed a study on life expectancy of rock stars which found that rock stars do tend to die young. From the Reuters story:

American stars Jerry Garcia of the Grateful Dead, Carl Wilson of the Beach Boys and Johnny Ramone of the Ramones all died in their 50s.

Bellis suggested that the high death rate among older American musicians could be related to the continent's greater appetite for reunion tours, exposing the artists for more years to an unhealthy "rock'n'roll" lifestyle.

It could also be due to the poor medical outlook for impoverished American ex-pop stars who have no health insurance, he said.

(emphasis added.)

The financial assets of most rock stars are private. However, for Jerry Garcia, we know more because his former wives fought publicly over his estate. Whatever the cause of Mr. Garcia's heart attack, it was not lack of money.

Socialized medicine watch

From Great Britain, the Daily Mail reports

A woman aged 108 has been told she must wait 18 months before the Health Service will give her the hearing aid she needs....

The one-time suffragette is one of hundreds of thousands of older people made to wait up to two years and sometimes more for modern digital hearing aids that make a dramatic difference to their ability to hear and communicate.

Single payer health care systems control cost by rationing. In this case, it will likely be successful in controlling costs since the 108-year woman is unlikely to still be alive when she turns 110 and her name comes to the top of the waiting list.

RELATED: While US liberals are advocated socialized ("single-payer") medicine as part of recent leftward trend, Jurgen Reinhoudt notes today in the WSJ that European leftists are moving right toward free enterprise.

Medical care and governmental control

The CDC made quick work tracking down the cause of 21 deaths in Panama, according to an AP report:

U.S. health officials this week cracked the case of what caused the mysterious deaths of 21 people in Panama since midsummer _ an industrial chemical in red cough syrup....

Some of the people who grew ill had been taking a sugarless cough medicine that was made in a pharmaceutical factory operated by Caja de Seguro Social, a government hospital system. That led investigators to test the medicine.

So the deadly medicine was manufactured by the government.

Problems with medical care are often greeted with calls for more government control. This Panama example illustrates that more government control is not always the answer.

UPDATE: China has several thousand coal mines that Chinese regulators say should be shut down for safety and environmental reasons but the mines are controlled by local governments (or local government officials) that won't obey the regulators. In this case also, more government involvement is not answer.