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Repeal of helmet laws a proven mistake

September 24th, 2010

U.S. Department of Transportation, National Highway Traffic Safety Administration

Effective July 1, 2000, Florida eliminated the legal requirement that all motorcycle riders wear helmets. State law now requires helmet use only by riders under the age of 21, or older riders who do not carry at least $10,000 of medical insurance. Observational surveys and crash reports indicated that helmet use dropped substantially following the law change. Motorcyclist fatalities increased by 81 percent comparing 2001-2003 to 1997-1999, compared to +48 percent nationally. Non-fatal serious injuries began increasing in the first six months of 2000, increased by 32 percent in the first year following law repeal. There was a 40 percent increase in the number of injured motorcyclists who were admitted to hospitals. Admissions for head injuries increased by 82 percent. The average head injury treatment cost increased by almost $10,000, to $45,602. In 1998 and 1999, the acute care hospital charges for head-brain-skull principal injury cases per 10,000 registered motorcycles were $311,549 and $428,347 respectively. The comparable figures for 2001 and 2002 were $605,854 and $610,386, adjusted for inflation. Time series analysis showed a statistically significant increase in fatalities while controlling for changes in motorcycle registrations. Similar analyses also showed significant increases for Kentucky, Louisiana and Texas. Florida crash reports also indicated that helmet use declined markedly among riders under age 21, who were still covered by the law. Fatalities in this age group nearly tripled in the three years after the law change. Comparing the 30 months before and after the law change, there was an increase of 55 percent in the average annual number of motorcyclists killed (181 to 280, respectively). Registrations increased an average 33.7 percent in this time period. Some of the increases in fatalities and other injuries in Florida were probably due to this increased ridership. The expected number of motorcycle fatalities as a result of the increase in registrations was 242. The actual number who died in 2002 was 301, 56 (+24 percent) more motorcycle fatalities than expected as a result of increased registrations alone. Nationally in 2001 and 2002, motorcycle miles of travel declined compared to earlier years.

Dr. Perlmutter’s comment:

This was obviously the wrong thing to do. The only ones benefiting from this are people waiting for organs for transplantation.

Dietary Supplements’ Safety Amounts to ‘Roulette,’ Doctor Says

October 12th, 2009

Dr. Perlmutter’s comment:
As you read this article, consider the fact that according to the American Medical Association more than 70,000 Americans die each year as a concequence of taking pharmaceutical medications “appropriately.”

From Bloomberg.com:

Consumers who take dietary supplements promising weight loss, increased strength or improved sexual performance may be playing “American roulette” with their health, said a Harvard Medical School doctor who urged stricter regulation of the products.

The U.S. Food and Drug Administration has identified about 140 contaminated products such as weight-loss pills that may cause high blood pressure, seizures, heart attacks or strokes, and body-building products that may cause liver injury and kidney failure from undeclared ingredients, said Pieter Cohen, a professor of medicine at Harvard Medical School in Boston. Current law allows dietary supplements to be sold without clearance from the FDA as long as they aren’t advertised as preventing, treating or curing disease.

About 114 million people, or half the U.S. adult population, take dietary supplements including vitamins, minerals and herbs, and sales of the treatments reached almost $24 billion in 2007, according to a report from the Government Accountability Office in March.

“Instead of pulling the trigger of a revolver at our head, we’re swallowing unknown substances that could have life- threatening effects,” said Cohen, whose article appears online today in the New England Journal of Medicine. “Selecting a dietary supplement is our version of spinning the cylinder of the revolver.”

Consumers should avoid products advertised as body- altering, Cohen said. Doctors should ask patients if they are taking supplements, particularly if they can’t easily diagnose symptoms.

‘What’s Inside’

“We have no idea what’s inside dietary supplements because the regulatory framework is so weak, they are not being approved by any government agency and there’s no proof of safety,” said Cohen, who also is an internist at Cambridge Health Alliance, in Cambridge, Massachusetts, in a telephone interview yesterday. “Without changing the regulatory framework, I don’t think it’s possible to make dietary supplements safer.”

As of next June, all dietary supplement manufacturers must follow new manufacturing practices that establish industry procedures for quality control and ensure that companies produce properly labeled supplements, said Andrew Shao, vice president of scientific and regulatory affairs for the Council for Responsible Nutrition, a trade association for dietary supplement manufacturers and ingredient makers.

‘Outliers’

“The majority of the dietary supplement industry is compliant, however we do feel that for the few outliers in the industry, the minority of the industry, we do very much endorse stepped up enforcement by the FDA,” he said yesterday in a telephone interview. “There is no FDA-regulated product that is immune completely to these kinds of problems. The majority of dietary supplement products are well made, are safe and there are no reasons for consumers who use supplements to change their behavior.”

Since 2007, the manufacturers have been required to notify the FDA of supplement-related deaths, hospitalizations and significant disabilities. Most of the 50,000 adverse events that the FDA estimates occur each year, including those that are mild and moderate, remain unreported, according to the GAO report released in March.

Approval Not Needed

“Consumers and health care providers should be aware that manufacturers and distributors do not need FDA approval to sell their dietary supplements,” Margaret Hamburg, the FDA commissioner, said yesterday in an e-mail. “This means that FDA does not keep a list of manufacturers, distributors or the dietary supplement products they sell.”

Manufacturers have the primary responsibility under the law to make sure their products are safe, Hamburg said. The law places the burden on the agency to demonstrate safety problems exist before acting. Reporting adverse events isn’t mandatory for consumers or health care providers and it’s important for consumers to be informed about the products they’re buying, she said.

The FDA warned yesterday that dietary supplements containing silver may cause permanent discoloration of the skin or mucous membrane. Large amounts of silver may quickly turn the skin, gums or nails or eyes shades of gray or blue, according to the advisory.

Colloidal silver, or metal particles suspended in liquid, is often marketed as an alternative to antibiotics or to treat diseases such as diabetes, HIV and cancer, according to the National Center for Complementary and Alternative Medicine.

Advisory Warning

Under current law, manufacturers of supplements must list all product ingredients on the label.

In July the FDA also issued a consumer advisory warning to avoid body-building products with labels that say the supplements contain steroids or steroid-like substances. That same month the U.S. Department of Justice filed a complaint against three New Jersey companies alleging they manufactured their dietary supplements and protein powders under filthy conditions and didn’t list known food allergens on the product labels.

Robert Saper, director of integrative medicine and an assistant professor at Boston University School of Medicine, said dietary supplement manufacturers should have to demonstrate that their products are safe before they go on the market. One way to do that would be having an independent third party verify those products, he said.

Saper’s study last year in the Journal of the American Medical Association found that one in five herbal products used in Ayurvedic, or traditional Indian, medicines contained harmful levels of toxic metals.

Cohen said Congress must give the FDA more authority and resources to regulate the dietary supplement industry.

As of 2008, about 75,000 dietary supplements were available to consumers, an increase from about 4,000 in 1994, according to the GAO report.

Calcium, Folic Acid

Using supplements such as calcium and folic acid as well as other alternative medicines should be allowed as long as it’s safe, said Cohen of Harvard.

“If people want to take a garlic pill, I see no reason that they shouldn’t be able to take a garlic pill, but if they go and buy a garlic pill, they should make sure garlic is the only thing in there,” he said.

Shao, the supplement industry representative, said consumers should be cautious about products promising a “magic bullet” and should choose supplements made by brands they know and trust.

“These few companies, these outliers, they are undermining consumer confidence,” he said. “We support regulators going after them.”

In public health bill, a contagion of fear

September 20th, 2009

From Boston.com:

The banner, bold and provocative, was tattooed with a syringe, skull and crossbones, and a call to action: “Say no to forced vaccination.’’

The message, delivered last week on Beacon Hill, was aimed at a seemingly prosaic piece of legislation that aims to better define – and, in some respects, restrict – the emergency powers of the state’s public health officials.

Within the bill’s arcane language, a 16-month-old activist coalition sees government authority run amok: mandated vaccinations, quarantines, arrests, fines. Swine flu, they warn, will be the virus that opens the door to the public health police.

“We have a concern that we will be forced to be quarantined if we refuse the vaccine,’’ said Laura Jackson, president of the Liberty Preservation Association of Massachusetts, which mustered 30 to 40 members for the lobbying drive. “What I’d like to see done with this law is have it burned.’’

Those concerns, public health authorities insist, are entirely unfounded. But the association’s multimedia campaign – aired over talk radio and its website – compelled state Public Health Commissioner John Auerbach to send an italicized, bold-faced missive to legislators, stressing that “mandatory vaccination is not and has never been part of the plan or discussion in Massachusetts’ pandemic response.’’

The bill, Auerbach and other top officials said in interviews, would never force anyone to be vaccinated unwillingly, and its extraordinary measures – such as quarantining people who decline inoculations – would be reserved for equally extraordinary times, such as a bioterror attack or the emergence of a highly lethal, rapidly spreading germ. Swine flu, caused by the H1N1 virus, is not such a germ, Auerbach said.

The protest by the group, whose founders supported Republican Ron Paul in the 2008 presidential election, reached its pitch at an especially delicate moment for public health authorities. Auerbach’s letter demonstrates that his agency is worried the dissent could raise doubts about vaccination and imperil an unprecedented campaign to inoculate millions this fall against the seasonal flu and the swine strain.

“Accuracy of information is going to be key in terms of the public understanding what they should do,’’ Auerbach said in an interview.

In the opposition to Massachusetts’ revised public health emergency law, as well as in the combustible health care town hall meetings that greeted some members of Congress this summer, analysts see more than traditional conservative concerns about individual liberty and big government.

They also find signs of deeper worries about a world descending into uncertainty, with panic over economics and the emergence of a novel flu strain.

“It doesn’t surprise me that when you have another epidemic, another threat of a disease, then you get emotions tweaked up, and separately in the health care debate, we’ve seen a rise in emotionalism replacing logic,’’ said Gene W. Matthews, a senior fellow at the University of North Carolina’s Institute for Public Health.

Matthews was among those who presided over efforts to update public health emergency regulations when he was the top attorney at the US Centers for Disease Control and Prevention.

The terrorist attacks of Sept. 11, 2001, and the arrival of anthrax-laced letters at congressional and media offices a month later revealed a largely ignored truth about those laws: In many states, they had not been updated for decades.

A team led by Lawrence O. Gostin, a Georgetown University law professor, drafted the language that has served as a model for Massachusetts’ proposed law and for revised rules adopted in 37 states so far.

“Most of the laws were very antiquated,’’ Matthews said, “and they didn’t recognize concepts of due process and individual rights and legal evolution that had occurred in the last 50 years.’’

In times of emergency, medical authorities had long possessed sweeping powers to do what was necessary to protect the public’s well-being. According to the state Department of Public Health, such emergencies have been declared only three times since the 1970s, with the most recent being a 2006 order for aerial spraying to combat Eastern equine encephalitis in Southeast Massachusetts. In 1993, when West Stockbridge’s water supply ran dry, the agency used its powers to tap water from a private source. And in the 1970s, the state took control of a financially teetering nursing home.

The updated legislation, passed by the Senate in late April and awaiting action in the House, carries penalties for certain violations: People who refuse orders to remain isolated could face up to a month in jail and fines as high as $1,000 a day.

But the proposed law also would, in certain instances, provide a check on the power of health officials. For example, a judge’s approval would now be needed before a government agency could perform tests or a physical examination on someone thought to present a significant medical risk to the community.

Bob Dwyer, an opponent of the law, said the Liberty Preservation Association was “not trying to say don’t take the vaccines’’ against the flu.

Still, he said, he believes the emergency law “violates numerous rights that we have in the Bill of Rights and the Constitution,’’ including the right to freely assemble. The law is unnecessary, he insisted, because most people don’t need the threat of legal action to persuade them to remain home when they’re sick.

It’s understandable that some people might greet talk of quarantines with trepidation, said Valerie Bassett, executive director of the Massachusetts Public Health Association.

But such measures, taken in rare circumstances, are “the same reason you drive within the lane on the highway,’’ Bassett said. “It’s about the protection of health and life.’’

Experimental Drug Access Expanded for Seriously Ill

August 14th, 2009

From Bloomberg.com:

Seriously ill patients will be allowed greater access to experimental drugs under regulations approved by the U.S. Food and Drug Administration.

The rules let drugmakers give or sell experimental medicines to patients who have no other options, including in emergencies, the agency said today on its Web site. Patients and doctors can see a new Web site to learn about the use of experimental treatments as part of a clinical trial or outside of one, the FDA said in a statement.

The FDA has allowed tens of thousands of patients access to unapproved therapies since the 1970s, the agency said in its statement. The regulations clarify existing programs for providing novel medicines through clinical trials and expand drug access to additional groups of patients. The rule changes adopted today were proposed in December 2006 and may provide experimental drugs to as many as 3,095 more patients each year, the agency said.

“The final rules balance access to promising new therapies against the need to protect patient safety,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in the statement. “Clinical trials are the most important part of the drug development process in determining whether new drugs are safe and effective.”

Protecting Trials

Some drugmakers and their trade organizations told the FDA that expanded access outside of clinical trials might impede the development of new drugs, since there would be less reason to participate in those studies, according to comments on the agency’s Web site. Clinical trials are used to test safety, dosing and effectiveness of new drugs and support applications for drug approvals. The trials attract participants by offering access to treatments that otherwise may not be available.

The Standard & Poor’s 500 Pharmaceuticals Index of 13 companies rose less than 1 percent to 268.73 at 4 p.m. New York time.

Under the rules, the company and the FDA must agree to allow pre-approval use of a drug, Woodcock said today during a conference call. Companies will have the option of charging patients for the cost of producing and administering drugs when not given as part of a trial. The regulation is meant to encourage companies that may not be able to afford to provide a drug for free, the FDA said.

“On the surface, it doesn’t look like this is going to have a great impact or be a new revenue boon,” said David Heupel, a portfolio manager at Thrivent Financial for Lutherans in Minneapolis, in an interview. “The intentions here are good. They want to make it easier for somebody who is really out of treatment options to try something that might have some benefit.”

Unintended Consequences

The expanded access could have the unintended consequence of making drug approval more difficult, Heupel said. Whenever a patient gets sick or dies while taking an experimental medicine, that must be reported to the FDA. When the therapies are given to very sick patients outside the close monitoring of a clinical trial, such reports could make regulatory evaluations of a drug’s safety “a little more cloudy,” Heupel said.

“Three thousand patients is just a drop in the bucket,” said Frank Burroughs, a founder of the Abigail Alliance, an advocacy group that supports allowing more patients to use experimental drugs. “These regulations do very little to increase expanded access.”

The FDA should do more to protect drugmakers from lawsuits over experimental drugs and allow patients to receive treatments at early stages of clinical development, Burroughs said.

Choice to Charge

“We support the FDA’s efforts to improve access to investigational drugs for patients with serious or immediately life-threatening diseases,” said Ken Johnson, senior vice president of the industry group, Pharmaceutical Research and Manufacturers of America, or PhRMA. “As to charging for investigational drugs, these are decisions that will have to be made individually by research sponsors.”

If a drugmaker wants to charge for a therapy as part of a clinical trial, the company must provide financial information to the FDA and persuade the agency it couldn’t otherwise offer the drug, Woodcock said. Testing and administration expenses can’t be charged in trials.

About 162 to 3,095 additional patients may gain access to experimental drugs each year because of the rule changes, the FDA estimated in its documents.

Woodcock said it’s too early to know the exact numbers and the agency will track the program, which is scheduled to take effect in two months.

“I don’t think this will radically expand access, but we believe a large number of clinicians, investigators, patients and patient groups who weren’t totally aware of these programs will now become aware of them and will have access,” she said.

To contact the reporter on this story: Tom Randall in New York at trandall6@bloomberg.net.

Red Bull Cola banned for containing cocaine

June 11th, 2009

From thelocal.de/national:

The consumer ministries in the two states confirmed on Friday they had ordered retailers to pull the drink off their shelves after a food safety institute in North-Rhine Westphalia found cocaine in samples of the beverage.

“The institute examined Red Bull Cola in an elaborate chemical process and found traces of cocaine,” Bernhard Kühnle, head of the food safety department at the federal ministry for consumer protection said.

Authorities said the cocaine levels do not pose a health threat but are not permitted in foodstuffs.

The Frankfurter Neuen Presse reported that the investigation was prompted by the use of a de-cocainized extract of coca leaf in the drink. That means the drink cannot be classified as a foodstuff but as a narcotic and needs a special license, authorities said.

The newspaper reported that German retail group Rewe had already issued orders to remove the fizzy drink from its shops. Wilhelm Deitermann, spokesman for the North-Rhine Westphalia consumer ministry said he expected other German states to follow suit and ban the drink.

But Red Bull Cola has protested the action. “De-cocainized extract of coca leaf is used worldwide in foods as a natural flavouring,” the paper quoted the company saying. The company added that Red Bull Cola as well as other food that contains coca leaf extract is considered safe in the EU as well as in the US.

The more popular Red Bull, dubbed the “clubbers’ drink,” is often mixed with vodka. It contains caffeine, vitamins, and sugar which, the company claims, kick-starts the body’s metabolism and keeps people alert.