FDA Takes Action Against KV Pharmaceutical Company

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Posted on 20th March 2009 by Gordon Johnson in Uncategorized

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The below story is from the FDA website. It is one more example of the broken American pharmaceutical industry.

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FDA News
FOR IMMEDIATE RELEASE
March 2, 2009

FDA Takes Action Against KV Pharmaceutical Company
Company Making, Marketing and Distributing Adulterated and Unapproved Drugs
The FDA announced a Consent Decree of permanent injunction filed March 2, 2009, enjoining KV Pharmaceutical Company, its subsidiaries ETHEX Corporation and Ther-Rx Corporation, and its principal officers from making and distributing adulterated and unapproved drugs. The injunction against KV and the other defendants, once entered by the court, will prevent them from manufacturing and shipping drugs until the firm obtains FDA approval. It will remain in place until the defendants sustain continuous compliance with FDA’s current Good Manufacturing Practice (cGMP) and new drug approval requirements for six years.

The Consent Decree also enjoins KV’s officers David A. Van Vliet, president and chief executive officer; Rita E. Bleser, president of the pharmaceutical division; Jay S. Sawardeker, vice president of corporate quality, and Marc S. Hermelin, former chief executive officer and a member of KV’s Board of Directors, from manufacturing and distributing any drug at or from KV’s facilities until the company’s procedures and products are brought into compliance with the law.

KV Pharmaceutical manufactures, processes, packages, labels, holds, and distributes drugs from various locations in St. Louis, Mo., and the surrounding area. FDA inspected KV between December 2008 and February 2009, and found that the company had significant cGMP violations and continued to manufacture unapproved drugs. As a result of those inspections, which led to this action, KV recalled all products manufactured and distributed from its facilities.

“The FDA requires companies to manufacture drugs in accordance with the current good manufacturing practice standards and to comply with FDA approval requirements,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research (CDER). “Consumers need to be confident that drugs meet our manufacturing requirements for identity, strength, purity, and quality, and have been evaluated by the FDA for safety and efficacy.”

Under the terms of the Consent Decree, the defendants cannot resume manufacturing and distributing drugs until both an independent expert and FDA officials conduct inspections of their facilities and certify that they are in compliance with the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations, and the decree. The Consent Decree also requires the defendants to destroy all drugs they recalled between May 2008 and Feb. 3, 2009. Those drugs are currently in their possession.

If the defendants fail to comply with any provision of the Consent Decree, the Act, or FDA regulations, FDA may order the firm to again stop manufacturing and distributing drugs, recall the products, or take other corrective actions.

“The FDA will carefully monitor the provisions of this injunction against the KV Pharmaceutical Company to ensure compliance,” said Michael Chappell, the acting associate commissioner of FDA’s Office of Regulatory Affairs. “Companies should know that FDA will investigate and take action against other marketers of unapproved drugs.”

The Consent Decree subjects the defendants to liquidated damages of $15,000 per day if they fail to comply with any of the provisions of the decree, and the payment of an additional $15,000 for each violation, up to $5 million per year.

For more information:

FDA/CDER Web page on Compliance with Current Good Manufacturing Practices
http://www.fda.gov/cder/dmpq/

FDA’s ongoing efforts against marketed unapproved drugs
http://www.fda.gov/cder/drug/unapproved_drugs/

Federal Agents Seize more than $24M in Unapproved New Drugs
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01868.html

Ethex Corporation Initiates Nationwide Recall
http://www.fda.gov/oc/po/firmrecalls/ethex12_08.html

KV Voluntarily Suspends Shipments of all its Approved Tablet Drugs
http://www.fda.gov/oc/po/firmrecalls/kv12_08.html

Link to CPG guidance, http://www.fda.gov/cder/Guidance/6911fnl.htm

INSIDE WASHINGTON: Is the FDA a broken agency?

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Posted on 3rd March 2009 by Gordon Johnson in Uncategorized

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Date: 3/3/2009

EDITOR’S NOTE — An occasional look at how Washington works — or doesn’t.
By RICARDO ALONSO-ZALDIVAR and MIKE BAKER
Associated Press Writers

WASHINGTON (AP) — Tainted peanuts. Unsterilized syringes. Salmonella in Mexican chili peppers. A contaminated blood thinner from China that sent patients into life-threatening shock.

Every few months, the Food and Drug Administration goes into fire-brigade mode, rushing to get control over another safety crisis. The agency that regulates products worth 25 cents of every dollar spent by U.S. consumers seems overwhelmed by its own mission.

Some say the FDA is broken, and others want to break it up — by moving food safety to a new office.

“You’ve got an agency that quite frankly is either non-functional, or dysfunctional, or maybe all of the above,” said Rep. John Dingell, D-Mich., who as the longest serving member of Congress has investigated many agencies, including the FDA.

“Bet yourself a new hat or a fine dinner that you are going to have a scandal a month,” Dingell added. “They are running around like a lot of headless chickens.”

Others, even some critics, see tentative improvements. Many defenders acknowledge the FDA is struggling.

“‘Broken’ is the kind of word that’s sort of a fighting word,” said Dr. Frank Torti, the cancer researcher serving as acting FDA commissioner. “We have recognized for a long time that more is needed. Because of a lack of (legal) authorities and inadequate resources, it’s really hard to do the job.”

Restoring the FDA’s reputation will be a major challenge for an Obama administration that strode into town promising competent government.

The decline didn’t happen overnight. There’s no single, simple cause. In 2007, an independent group of science advisers concluded that the FDA was in danger of failing in its mission. “American lives are at risk,” said their report. It wasn’t the first alarm.

As the pharmaceutical and food industries went global in recent years, the FDA fell behind on inspections. Its legal powers failed to keep up with fast-changing industries. Its own scientists said it grew too cozy with drug companies and tuned out signals of safety problems.

Money for research grew scarce. The agency struggled to answer such seemingly simple questions as how far from a cow pasture a farmer should plant his spinach patch to keep out bad germs. Internal computer systems were allowed to decay, although they are essential to monitoring drug safety trends or blocking shady imports.

The FDA drifted. During the Bush administration, it went long periods without a permanent commissioner who could be an advocate before Congress. Lawmakers piled new responsibilities on the agency, often without the funds to carry them out.

This past year’s safety problems — homegrown and imported — illustrate the FDA’s weakness.

Summer brought a salmonella outbreak blamed first on tomatoes, and later on hot peppers as well.

This winter, it was salmonella again, in peanut products. A small company’s apparent disregard for basic sanitation led to the recall of more than 2,800 foods that used its ingredients.

More than 2,100 people were sickened in these incidents. At least nine deaths have been blamed on tainted peanuts alone.

Last week, another problem surfaced. Federal prosecutors in North Carolina obtained guilty pleas from two employees of AM2PAT, a company that manufactured syringes in unsterile conditions and covered it up with phony paperwork.

Prosecutors say hundreds of patients were sickened and five died. The FBI is looking for the company’s owner, who may have fled the country.

Different products were involved in the incidents, but some of the same FDA shortcomings: inspections, legal authority and technology.

It was unclear how many foreign drug facilities fall under the FDA’s jurisdiction because one government database lists about 7,000 and another, 3,000.

Sending inspectors to China used to involve first waiting for permission from the Chinese government. The situation has improved, under a U.S.-China agreement that led to the opening of FDA offices there.

The tomato outbreak last summer underscored other kinds of gaps. Produce companies are not required to have a food safety plan. And the FDA lacks legal authority to require a system for tracing foods back to the farm. Investigators had to sift through piles of paper records as losses mounted for tomato growers. Dingell said the FDA looked like the Keystone Kops.

In the peanut butter outbreak, the FDA has been slowed because of the length of time it takes to identify positively a strain of salmonella. The agency wants to replace current lab tests that can take a week or more with technology that cuts the wait to a day or two.

FDA inspectors quickly descended on the small Georgia facility at the center of the peanut outbreak. But they didn’t get the whole story immediately. The FDA had to invoke bioterror laws to get lab reports that ultimately showed the company shipped tainted peanuts. Meantime, the agency had no authority to order a food recall.

“The FDA has been trying to do so much with so little for so long that they really have lost the vision of what would make an effective food safety program,” said Caroline Smith DeWaal, food safety director for the Center for Science in the Public Interest, which wants to set up a separate food agency.

Congress has been pumping more money into the FDA the last couple of years. And the Obama administration seems willing to consider big changes, especially on food safety.

The two leading candidates for FDA commissioner are physicians from outside the agency. One is Baltimore health commissioner Joshua Sharfstein, a pediatrician who has taken on the FDA over risks in children’s cough and cold drugs. The other is Margaret Hamburg, a bioterrorism expert who served in the Clinton administration and as New York’s health commissioner.

“One area where we could see bipartisan cooperation might be the strengthening of the FDA,” said Dr. Paul Stolley, a former department head at the University of Maryland medical center who had a stint as a visiting scientist at the FDA. “I don’t think ideological differences should interfere.”

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Baker reported from Raleigh, N.C.

___

On the Net:

FDA Science Board report — http://tinyurl.com/yvnk28

Copyright 2009 The Associated Press.

Inspection reports from peanut plant varied widely

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Posted on 2nd February 2009 by Gordon Johnson in Uncategorized

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Date: 2/2/2009

By KATE BRUMBACK and GREG BLUESTEIN
Associated Press Writers

BLAKELY, Ga. (AP) — A Georgia health inspector who toured the peanut butter plant now at the center of a national salmonella outbreak noted only two minor violations in October. Less than three months later, federal inspectors found roaches, mold, a leaking roof and other sanitation problems.

Food safety experts say the lapse is a major concern and shows state inspectors are spread thin and might need more training on how to spot unsanitary conditions.

“It’s surprising to me that that many major deficiencies were observed at one time, and none of these were picked up previously,” said Michael Doyle, head of the food safety center at the University of Georgia.

In October, state inspector Donna Adams noted only two violations in her report on the Peanut Corp. of America plant: tote containers with butter residue and “black buildup” and “mildew and possibly some static dust on ceiling of butter storage room.”

No samples of the finished product were taken for salmonella testing during the October inspection, despite a push by the state to check for the bacteria after a salmonella outbreak was traced to another Georgia peanut butter plant in 2007.

The October report showing only minor violations seems to conflict with conditions observed by at least one former employee, though others said they saw no problems.

Jonathan Prather, who said he worked in the plant’s peanut butter room until he and most of the plant’s other employees were recently laid off, said he sometimes saw old and soggy peanuts being used and other unsanitary conditions. When he raised concerns about the plant’s cleanliness, Prather said he was ignored by managers.

“The only thing they said is, ‘We’ll handle this, we’ll handle the problem,’” he said. “But I don’t see that they did because if they had, none of this would have happened.”

Another former employee, Jimmy Boozer, said he worked at the plant for six years and never noticed any unsanitary conditions. Co-worker Lewis Smith, who had been working at the plant for about two years, said the plant appeared generally clean. One problem Smith noticed was a roof that leaked for months and continued to leak even after plant managers said it had been repaired.

A leaky roof would likely cause some concern for inspectors: After the 2007 salmonella outbreak was linked to a Georgia peanut butter plant operated by ConAgra Foods Inc., company officials said jars were contaminated when moisture from a roof leak and a malfunctioning sprinkler system mixed with dormant salmonella bacteria in the plant.

Adams, who inspected the plant twice last year, did not come to the door to speak to a reporter who visited her home in southwestern Georgia. A man who identified himself as her husband referred all questions to the state.

Georgia agricultural officials did not return repeated phone calls and messages seeking comment. Earlier in the week, Agricultural Commissioner Tommy Irvin defended his inspectors, saying they did the best they could with limited manpower and funding.

Irvin said the department has about 60 inspectors responsible for examining 15,000 sites — or 250 food sources per inspector — ranging from ice machines to sprawling factories. Some territories are left uncovered, forcing the state to shift employees from one area to another.

Peanut Corp. did not respond to several requests asking for details of plant operations. The company issued a general statement late Friday that emphasized its top concern continues to be ensuring public safety.

“For Peanut Corporation to engage in any discussion of the facts at this point is premature,” the statement said.

The Food and Drug Administration said Friday it had asked the Justice Department to launch a criminal investigation into Peanut Corp., which authorities say shipped products that initially tested positive for salmonella after retesting and getting a negative result.

At least 529 people have been sickened as a result of the outbreak, and at least eight may have died because of it. More than 430 products have been recalled.

The 29-year-old Prather painted a grim picture of the facility, describing managers more concerned with the company’s bottom line than with properly cleaning the plant and equipment.

He said both soggy peanuts and peanuts in packages marked with dates showing they were five or six years old were dumped into the production line. The American Peanut Council, an industry trade association, says peanuts need to be kept dry to prevent mold and other risks.

Prather also said a dry roaster at the plant was halted only one day a month for cleaning. Doyle, the food safety expert, said peanut roasters should be cleaned and sanitized at least once a week.

“What they needed to do and what they didn’t do is clean up right,” said Prather, who noted the plant was sometimes shut down for cleaning on the weekends but said that wasn’t enough.

Doyle, who has been asked by the American Peanut Council to help review the industry’s practices, said the state would likely have to provide inspectors with “more in-depth training in terms of the really critical areas.”

And he said it’s a problem that likely spans far beyond Georgia.

“It’s something the federal government is going to have to take a lead role on, to develop criteria for different producers,” Doyle said. “I think this peanut plant is just an example of the weakness in our system.”

___

Greg Bluestein reported from Atlanta.

Copyright 2009 The Associated Press.

FDA scientists complain to Obama of 'corruption'

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Posted on 12th January 2009 by Gordon Johnson in Uncategorized

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Date: 1/8/2009

By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) — In an unusually blunt letter, a group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the Food and Drug Administration.

“The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk,” said the letter, dated Wednesday and written on the agency’s Center for Devices and Radiological Health letterhead.

The center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery. The concerns of the nine scientists who wrote to the transition team echo some of the complaints from the FDA’s drug review division a few years ago during the safety debacle involving the painkiller Vioxx.

The FDA declined to publicly respond to the letter, but said it is working to address the concerns.

In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.

“Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices…have ignored serious safety and effectiveness concerns of FDA experts,” the letter said. “Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid.”

A copy of the letter, with the names of the scientists redacted, was provided to The Associated Press by a congressional official.

“Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around,” the scientists wrote.

FDA spokeswoman Judy Leon said in response: “We have been working very closely with members of the transition team and any concerns or questions they have on any issue, we will address directly with the team. Separately, the agency is actively engaged in a process to explore the staff members’ concerns and take appropriate action.”

Senior Democratic and Republican lawmakers are urging Obama to appoint a commissioner who will shake up the FDA and restore the confidence of its working-level scientists and medical experts. But industry officials fear that approval of new drugs and devices could be delayed by endless scientific disputes — which is the agency’s reputation.

The FDA dissidents have previously taken their concerns to Congress and found support from lawmakers in the House.

In the letter the group singled out mammography computer-aided detection devices as an example of a technology that should not have gone forward. The devices were supposed to improve breast cancer detection, but instead studies showed they were associated with false alarms that led to unnecessary breast biopsies.

Since 2006, FDA experts have recommended five times against approving the devices without better clinical evidence, the letter said. In March of last year, a panel of outside advisers supported some of the concerns of the FDA’s in-house scientists. Nonetheless, FDA managers overruled the objections and ordered approval.

Top FDA managers “committed the most outrageous misconduct by ordering, coercing and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along,” the letter said.

A spokeswoman said the Obama transition team had no comment.

Copyright 2009 The Associated Press.

FDA: Risks of new asthma drugs vary

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Posted on 5th December 2008 by Gordon Johnson in Uncategorized

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Date: 12/5/2008 2:54 PM

By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) — The blockbuster asthma drug Advair does not appear to have an increased risk of serious complications seen with similar new medicines, federal health officials said Friday.

But a less widely used medication, Serevent, had a significantly higher rate of serious complications, and even deaths, the Food and Drug Administration said. Both medicines are made by the same company, GlaxoSmithKline.

The FDA is concerned about asthma drugs known as LABAs, long-acting medications that relax tight muscles around stressed airways and free patients from the need to take a puff from their inhaler every few hours. For many asthma sufferers, that means they can sleep through the night.

But LABAs, for reasons that are still being debated, can increase risks of death and complications in some patients. The risk is lower when a LABA is used together with a steroid to treat underlying inflammation deep inside the airways.

Advair combines both kinds of medicine in one inhaler. But Serevent is a LABA-only product, although medical treatment guidelines call for patients taking the medication to also use a steroid.

The FDA analyzed reams of clinical data on four drugs: Advair, Foradil, Serevent and Symbicort. All four already carry strong warnings, but the findings could lead to more specific instructions for patients and greater restrictions on some of the medications. The agency has called a special meeting of outside advisers next week to discuss the data and make recommendations.

GlaxoSmithKline said the analysis underscored its confidence in Advair, its best-selling medication, with U.S. sales of $2.9 billion in the first nine months of this year. But a spokeswoman declined to comment on whether the data could lead to a withdrawal of Serevent, which had U.S. sales of $97 million in the same period. About 4 million U.S. patients now use the Glaxo medications.

Asthma is a chronic respiratory illness that leaves patients short of breath, wheezing, and can sometimes send them to the emergency room because of difficulty breathing. Some 22 million people in the United States suffer from asthma, and children account for nearly one out of every three patients. Nearly 3,600 people still die from asthma in this country each year, although symptoms can be controlled with medication to prevent the most serious complications.

Copyright 2008 The Associated Press.

FDA to study phone number to report side effects

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Posted on 25th November 2008 by Gordon Johnson in Uncategorized

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Date: 11/25/2008

By MATTHEW PERRONE
AP Business Writer

WASHINGTON (AP) _ The Food and Drug Administration plans to interview more than 1,500 consumers to decide whether television drug advertisements should urge patients to report side effects.

The regulatory agency is considering requiring TV promotions to carry a toll-free number where patients can report serious problems with their medication. However, some critics argue the toll-free number could distract viewers from other important safety information about the drugs.

Print advertisements already include contact information for the FDA, as required by a law passed last September. The legislation ordered the FDA to report to Congress by late March whether that information should also be mandatory for TV ads.

But the agency requested more time to complete its work and is expected to soon begin a formal study of the question — well over a year after the drug safety legislation was signed into law.

On Tuesday the agency laid out plans for a large-scale study to assess whether adding instructions about reporting side effects would overwhelm viewers who are already being bombarded by medical information.

Pharmaceutical “ads are already quite dense when compared with ads for other products,” the agency states in documents posted online. “The risk information should not be compromised by the addition of the toll-free statement.”

Drug promotions are already required to list a drug’s benefits and risks.

For its study, the FDA will show ads for a fictitious blood-pressure drug to 1,600 consumers, who would then be interviewed to see how much of the information they understood. Specifically, researchers will assess how the placement, time and wording of the statements affects comprehension.

Regulators did not say when they would launch the study, but the FDA said it would accept comments on the proposal for the next two months.

The Pharmaceutical Research and Manufacturers of America has not yet taken a stance on the issue. However, the group — which represents Merck & Co. Inc., Pfizer Inc., Wyeth and other drugmakers — supported adding the language about side effects to print ads.

TV promotions have become a cornerstone of the pharmaceutical business since regulators opened the floodgate a decade ago. Companies spent roughly $3.5 billion on commercials last year.

But some lawmakers and consumer advocates say the advertisements can encourage over-prescribing of medications before all their side effects are known. By encouraging patients to report negative reactions to FDA, they hope regulators will be able to catch drug safety problems sooner.

By the time the FDA completes its study of the toll-free number, policymakers in the now Democrat-dominated Washington may have already moved ahead with even stricter regulations.

Rep. Rosa DeLauro, D-Conn., introduced a bill this spring that would ban consumer-directed advertisements during the three years after a new drug’s launch. The proposal is aimed at limiting the use of new drugs until they have been demonstrated safe.

The legislation would also require drugmakers to mount public awareness campaigns about the risks of certain types of drugs. DeLauro is expected to reintroduce the measure next year.

“The FDA has important drug oversight responsibilities, and the push to promote new drugs and devices should not get in the way,” DeLauro said, upon releasing the bill.

Copyright 2008 The Associated Press.

FDA: Epilepsy drug may be risky for Asians

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Posted on 24th November 2008 by Gordon Johnson in Uncategorized

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Date: 11/24/2008

WASHINGTON (AP) _ Treatment with certain epilepsy drugs may expose some Asian patients to serious skin reactions, federal health officials warned Monday.

The Food and Drug Administration said it is investigating whether medications like Dilantin, Phenytek and Cerebyx, which are used to control epileptic seizures, can lead to severe skin blisters and bleeding for some Asian patients.

Patients who test positive for a gene known as HLA-B1502 appear to be at increased risk of developing the skin problems, preliminary data indicate. About 10 percent to 15 percent of patients from parts of China, Thailand, Malaysia, Indonesia and the Philippines may carry the gene, as do 2 percent to 4 percent of South Asians, including Indians.

The FDA urged doctors to monitor patients closely, but said there is not enough information yet to recommend genetic testing. In most cases, patients who develop the skin problems do so in the first few months after starting to take the medications.

Because of the problem with skin reactions, the FDA last year recommended genetic testing for Asian patients taking another epilepsy drug, carbamazepine, sold under several brand names including Tegretol and Carbatrol. Doctors should also avoid Dilantin and the other medications for patients who have already tested positive for the gene, the FDA said.

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On the Net:

FDA safety alert: http://tinyurl.com/5fcnlf

Copyright 2008 The Associated Press.

FDA panel:Tell consumers about facial filler risks

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Posted on 18th November 2008 by Gordon Johnson in Uncategorized

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Date: 11/18/2008

By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) _ Hundreds of thousands of baby boomer women who think they’ve found an antidote to aging in cosmetic facial fillers must be better informed of possible risks, government health advisers said Tuesday.

A panel of independent advisers urged the Food and Drug Administration to revise the labeling to include the possibility of long lasting reactions such as bumps under the skin, blotches and scars.

“It is almost a no-brainer,” said Dr. Michael Bigby, a Harvard Medical School dermatologist. “The current label is not adequate.” The gel-like fillers, which have become hugely popular in the last few years, are injected into the face to smooth away wrinkles.

Manufacturers and plastic surgeons say fillers have an excellent safety record. But Tuesday’s FDA hearing raised questions about unapproved uses, untrained technicians giving injections, and a lack of long-term safety data. The hearing was a first step as the FDA considers whether to regulate fillers more closely.

Plastic surgeons pledged to help the government track safety, improve training and provide clearer information to consumers.

Women, and even some men, are drawn to skin fillers by the promise of youthful good looks at far less cost and trouble than a face lift. A touchup two or three times a year can boost deflated middle-age egos. Unfortunately, for some patients, the result can be blotchy skin, bumps on the face and worse.

Different from Botox, which is derived from a toxin that acts on facial muscles, wrinkle fillers are like the biological equivalent of a bit of spackle, except they’re injected into the face. They include such products as Juvederm, made by Allergan, Inc., and Restylane, from Medicis Aesthetics Holdings.

FDA officials are concerned that fillers are being used for purposes they were never tested and approved for, such as plumping the lips, which are extremely sensitive.

There are also questions about a lack of clinical evidence on how darker-skinned patients fare with the beauty treatments. More black, Latino and Asian patients are trying plastic surgery, and some information suggests they may be susceptible to unsightly blotches and other complications from fillers.

“The trouble is that once this material is in the hands of physicians, there’s really not much control over how it’s used and where it’s placed,” said Dr. Scott Spear, a Washington plastic surgeon. “That creates the potential for a certain amount of mischief.

“But the good news is that, by and large, these are very safe materials,” Spear added. “They have a very healthy risk profile.”

FDA scientists will present the advisory panel with data on 823 patients who suffered serious reactions after treatment with fillers between 2003 and this September. The overwhelming majority were women, and the most common age group was 50- to 60-year-olds. Plastic surgeons performed some 1.5 million cosmetic surgery procedures with fillers last year alone.

Although no deaths were reported to the FDA, the complications were troublesome enough that 638 of the patients required follow-up medical treatment.

Most reactions involved minor swelling and redness, complications that could be expected. But the FDA said it also received reports of “serious and unexpected” problems, including facial, lip and eye paralysis, disfigurement, vision complications and some severe allergic reactions.

A small number of patients — 19 — went to the emergency room with life-threatening allergic reactions, such as difficulty breathing. Twelve developed infections that required hospitalization.

“The FDA has been rushing these products to market as if they were lifesaving medical products,” said consumer activist Diana Zuckerman, president of the National Research Center for Women & Families. “They should be requiring better studies since these products have only cosmetic benefits but potentially lethal risks.”

Some problems reported to the FDA may be due to unapproved or “off-label” use of fillers. For example, the FDA does not recommend them for plumping the lips, but some doctors see no problem with that.

Another challenge is the sheer variety of fillers. Most are eventually absorbed into the body, but one type contains tiny, round, smooth plastic particles that the body does not absorb. Some are made from natural substances and others are not. That means they may react differently in the body.

___

On the Net:

Food and Drug Administration: http://tinyurl.com/5jtuxv

Copyright 2008 The Associated Press.

Amputee awaits high court, wants musical glow back

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Posted on 30th October 2008 by Gordon Johnson in Uncategorized

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Date: 10/30/2008

By DAVE GRAM
Associated Press Writer

MARSHFIELD, Vt. (AP) _ When Diana Levine turned 63 recently, her daughter made her a birthday card, drawing on Greek mythology with an illustration of Diana the Huntress, her bow string drawn taut, an arrow ready to fly.

But the arm pulling at the bowstring was amputated below the elbow — just like Diana Levine’s — and the target was labeled the “Wyeth monster.”

That’s Wyeth as in Wyeth Pharmaceuticals, the company Levine blames for a botched injection of the Wyeth-made drug Phenergan that led doctors to amputate her right arm in 2000.

Levine, once a professional guitar player and pianist, now plays with one hand and sings. “It’s about getting my glow back,” she said recently as she was awaiting a hearing Monday before the U.S. Supreme Court, where Wyeth is appealing a $6.7 million verdict in her favor.

The outcome of Levine’s case could have major ramifications for drug makers and consumers. The court is expected to decide whether people can sue under state law — or are pre-empted from doing so — for harm caused by a drug approved by the federal Food and Drug Administration.

Levine said the drug makers “are using my case … to get through this doctrine that will say that if it is FDA-approved, then we are not accountable, because FDA said it’s OK. … Mr. Pharmaceutical Company is not responsible and is not liable and doesn’t have to help the person who just lost her arm, or her life.”

Levine, who suffered from migraine headaches, had a particularly bad episode in the spring of 2000. A friend drove her from her dirt road farmhouse-turned-music studio in Marshfield, Vt. to a clinic in neighboring Plainfield.

She was given drugs for the pain and, to combat nausea, an intramuscular injection of Phenergan, a drug that has been around for 50 years.

When Levine complained that she still felt nauseous, the clinic suggested an “IV-push” of Phenergan. This delivered a high volume of the drug very quickly to her right arm, not the slow flow that could have been delivered by an IV drip.

The second injection accidentally punctured an artery, prompting gangrene to set in. After several weeks of deterioration, her arm was amputated.

Levine recalls first seeing what remained of her arm after surgery. “I was horrified and shocked and about as sad as I ever have been in my life,” she said.

She reached an out-of-court settlement with the clinic and sued Wyeth, contending that the label on the Phenergan she was given should have more clearly warned about the danger of giving the drug IV-push.

Combatting an upset stomach with a method that can end up causing limb loss is “an unfathomable benefit-risk ratio,” Levine said. With two other methods for injecting Phenergan, “there’s no earthly reason for this third option (IV-push) to even be made available,” she said.

Wyeth and the FDA say that when a drug like Phenergan has a federally approved label, its manufacturer is immune from lawsuits in state court. Wyeth maintains its label clearly describes the risks of Phenergan, and that it was not only approved but mandated by the FDA. “Wyeth could not change Phenergan’s labeling to comply with Vermont law without violating federal law,” it said in court papers.

Consumer groups are mounting a vigorous campaign against that position, saying federal regulation should represent the floor, not the ceiling, of a drug company’s responsibility.

“What a trial lawyer reasonably could fear in this case is that in one fell swoop, the U.S. Supreme Court would eliminate the right of an injured person to recover from a drug company in the case of a dangerous drug that caused their injury,” said Fordham University law professor Benjamin Zipursky, a product liability expert.

The court could effectively “eliminate all pharmaceutical company liability in this one case,” Zipursky said.

Bert Rein, a lawyer for Wyeth, said that concern was overblown. “Some of the hysteria being whipped up is really unjustified,” he said. “We believe the court will rule on the specific facts of the case,” rather than so broadly as to affect most liability claims.

That was not what Wyeth argued when urging the Supreme Court to take the case.

In its appeal to the court, Wyeth said the justices should act to prevent erroneous rulings in “tens of thousands of individual claims and potentially millions of class action claims” that are pending in state and federal courts.

While the legal war continues, Levine wages a more personal struggle. Sometimes it’s just to roll her left sleeve up or down, file papers, wash dishes or mow the lawn.

“If you were to put your hand in your pocket for a day and not use it, you would pretty much come to the conclusion that there’s nothing that’s a one-handed activity,” she said.

Mostly, the struggle is to continue a life in which songwriting was her gift and the guitar and piano were the tools of her trade.

“My identity was seriously damaged. Not just the musical one, but the physical. I mean, I had lost my glow, the glow was gone,” Levine said, recalling her recent performance with a group of women singers. “That’s what it’s about, it’s about getting my glow back.”

Levine has had more than a little help from her friends.

“She’s determined not to let this setback destroy her music,” said singer-songwriter Jon Gailmor, who had collaborated with Levine and her late husband in performances and on recordings. “It’s probably given her some new material, made her stronger even. She’s an amazing person.”

Quoting a musician friend, Levine calls the right hand the “joyous hand” — the one that gets to strum or pick the guitar, finding the rhythm, while the left searches the neck for the right note or chord. On keyboards, the right hand most often finds the improvisational riffs while the left lays down the underlying rhythm and chord changes.

Levine has no joyous hand now.

A piano and guitar player since childhood, she studied chemistry and psychology at the University of Vermont. Levine, who performed under the name Diana Winn, married a blues guitarist David “Crow” Levine, playing bass alongside of him in the Re-Bops, a band that gained a regional following in the 1980s.

Her husband died in 1993, leaving Levine and the couple’s daughter, Jessamine, now 25.

Now, she’s less concerned with the legal arguments than with making music and sharing it, especially with children.

She pays the bills using her monthly disability check from Social Security, Re-Bob Records sales — though she says she’s unable to keep up the business as well as she used to — and assistance from her family. “I have help from home. Nobody’s going to let me be out in the cold.”

Levine sat one recent afternoon at her
piano, accompanied by Jessamine on guitar, working out a new tune she hoped to send to actor Dennis Quaid, who is waging a drug labeling fight of his own after his infant twins were given a dose of the blood-thinnerHeparin — 1,000 times what was called for.

The twins’ birthday is in November, and Levine was writing a song for them.

Plunking out chords with her left hand, Levine asked Jessamine, “What do we go to there? Do you like G? Or should it be D-minor?”

And then she sang a song fragment:

“It’s the twinses’ birthday, celebrate times two. It’s the twinses’ birthday, if you only knew. There’s been some hard times they’ve both been through …”

Copyright 2008 The Associated Press.

Consumer group asks government to ban Avandia

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Posted on 30th October 2008 by Gordon Johnson in Uncategorized

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Date: 10/30/2008

WASHINGTON (AP) _ The government should ban the diabetes drug Avandia because of a wide variety of life-threatening risks, including heart and liver damage, a consumer group said Thursday.

The consumer group, Public Citizen, filed a petition with the Food and Drug Administration to have Avandia taken off the market.

It was the second setback in as many weeks for the GlaxoSmithKline medication, which at one time had shown great promise in reducing the blood sugar levels of people with Type 2 diabetes. Last week, the American Diabetes Association and a European counterpart jointly released updated treatment guidelines for doctors that pointedly recommended against using Avandia.

“The FDA is in possession of clear, unequivocal evidence that (Avandia) causes a wide variety of toxicities,” Public Citizen said in its petition. “Many of these are life-threatening, such as heart attacks, heart failure (and) liver failure.”

Avandia’s heart risks were brought to light two years ago in a medical journal article that reported a 43 percent higher risk of heart attacks among Avandia patients when compared with those taking other diabetes drugs. Although scientists are still debating a link between the drug and heart attacks, concerns about the medical evidence led to stronger warnings.

As a result, Avandia use dropped sharply but about a million U.S. patients still take it.

Public Citizen said its own research found 14 cases of liver failure associated with Avandia, 12 of which led to death. The petition also said Avandia predisposes some patients to eye problems, anemia and bone fractures.

Glaxo, in a statement, said it does not believe Avandia causes liver failure. The company said its own data shows the drug has a good safety record when it comes to liver problems. The company said the data on heart attacks is inconclusive and that Avandia is safe and effective, when used according to directions.

There was no immediate response from the FDA.

___

On the Net:

Public Citizen Web site: http://www.citizen.org/

Copyright 2008 The Associated Press.

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