Honolulu Personal Injury Lawyer - FDA & Prescription Drugs

Why Doesn't The FDA Follow Untested Drugs?

Wayne Parsons — Mon, 26 Oct 2009 13:51:07 GMT

A report from the General Accounting Office (GAO) questions why the FDA "has allowed drugs for cancer and other diseases to stay on the market even when follow-up studies showed they didn't extend patients' lives".

The FDA has an accelerated approval program that applies to serious illnesses that lets drugs on the market to help desperate patients but requires follow up studies.

But the GAO report names drugs that are still on the market apparently after failing to meet the FDA requirements. The question thus lies both with the FDA and with the drug manufactures. This is reminiscent of the Wall Street crisis where government regulators stood by and watched the entire financial system collapse.

According to the AP, the FDA responds that it has "overhauled [its] tracking system since the GAO completed its report." Principal Deputy Commissioner Dr. Joshua Sharfstein said that the FDA does not have a policy for pulling the drugs off the market because "we don't want to lock ourselves into a specific set of criteria." He "added that the agency has a task force assigned to look at policies like drug withdrawals."

Originally posted at InjuryBoard by Wayne Parsons

FDA commissioner endorses legislation to improve food safety.

Wayne Parsons — Fri, 23 Oct 2009 15:35:47 GMT

The Los Angeles Times (10/23, Zajac) reports, "Food and Drug Administration Commissioner Margaret Hamburg on Thursday strongly endorsed legislation that would give her agency new tools to improve food safety, but she warned that Congress still must find a way to pay for them if consumers are to benefit." The proposed "changes would require significant additional manpower and costly new computer systems, Hamburg told the Senate Health, Education, Labor and Pensions Committee." Committee Chairman Tom Harkin (D-IA) "urged the FDA to come up with cost estimates quickly because, he said, he didn't want to pass a bill that would be undermined by inadequate funding."

The Wall Street Journal (10/23, A2, Zhang) reports that Hamburg said the bill needs to be stronger and give that agency more authority as well as funding, asking that the Senate's bill more closely resemble that one that passed the House in July.

Originally posted at InjuryBoard by Wayne Parsons

ReGen Biologics Inc.'s Menaflex Device Said To Be "unsafe" - FDA Approves For Sale

Wayne Parsons — Fri, 25 Sep 2009 14:16:51 GMT

In a front-page story, the New York Times (9/25, A1, Harris, Halbfinger) reports that the FDA released a report Thursday that said "four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees." FDA reviewers had determined that ReGen Biologics Inc.'s Menaflex device was "unsafe" because it "often failed, forcing patients to get another operation." Still, in response to "'extreme,' 'unusual' and persistent pressure," agency managers "approved the device for sale," the report indicated.

Joshua Sharfstein, the agency's principal deputy commissioner, said the report "shows there were 'definite threats' to the integrity of the FDA's medical-device review process," and as a result, the agency is now "reconsidering its decision on" the device, the Wall Street Journal (9/25, A4, Mundy, Favole) reports. But, he added that "the report isn't a reason for patients...to panic." Sharfstein also said "the ReGen issue was one reason that the agency has begun a complete review of the 510(k) program," the "fast-track process...under which Menaflex was approved."

"The report offered several recommendations to insulate FDA staff from outside pressures, all of which," Sharfstein said "will be adopted," according to the Washington Post (9/25, Layton). Among issues flagged by the report were "problems in the way the FDA regulates the $200 billion-a-year medical-devices market."

In fact, the report said that "after the FDA twice rejected the company's request for fast-track approval, ReGen enlisted the support of New Jersey lawmakers, who called then-FDA Commissioner Andrew von Eschenbach on the company's behalf," the AP (9/25, Perrone) reports. Eschenbach then "became involved in the case and pressed reviewers to issue a decision quickly," Bloomberg News (9/25, Larkin) reports.

FDA to revisit decision on knee device after finding regulators faced pressure for approval.

Originally posted at InjuryBoard by Wayne Parsons

When Will Big Tobacco Stop Going After Kids - FDA Bans Flavored Cigarettes

Wayne Parsons — Wed, 23 Sep 2009 14:34:52 GMT

USA Today (9/23, Rubin) reports that on Tuesday, the FDA "banned the sale of candy-, fruit- and clove-flavored cigarettes. The move was authorized by the Family Smoking Prevention and Tobacco Control Act, which President Obama signed in June."

"These flavored cigarettes are a gateway for many children and young adults to become regular smokers," FDA commissioner Dr. Margaret A. Hamburg said, according to a front-page story in the New York Times (9/23, A1, Harris). The Times reports, however, that there has been confusion among distributors as to what constitutes a cigarette, and if flavored cigars or cigarillos are affected by the ban.

The story started back in the 1950s. Cigarette executives reviewed a report from their marketing department. It said that most of their best customers began smoking between the ages of 9 and 15 years of age. It said that by the time they realize that they are addicted, its too late for them to do anything about it and they were customers for life. The obvious conclusion to these morally bankrupt millionaire tobacco executives was to design slick adds that would appeal to 9-year-olds and start shopping for a bigger yacht and a new corporate airplane.

If you thought that the Billion Dollar tobacco settlement would change these folks, you were wrong. They are back with this new gimmick to hook kids on tobacco.

The Wall Street Journal (9/23, Dooren) reports that although the FDA warned against trying to circumvent the bans by introducing similar products, some flavored cigarette-like cigars are expected to stay on the market while the confusion persists.

The Washington Post (9/23, Layton) explains that FDA officials hope the ban will "cut down on the number of children and young adults who pick up the smoking habit." Lawrence Deyton, director of the FDA's Center for Tobacco, noted that "children are three times as likely as adults to smoke a flavored cigarette."

The White House's Assistant Secretary for Health, Howard Koh, called tobacco addiction a "public health catastrophe," ABC News (9/22, Hartman) reported on its website. Koh "put the cigarette industry on notice that this is just the beginning of a 'new chapter in public health efforts at tobacco control.'" Deyton noted that the FDA "will soon require...cigarette makers to turn over information about the 'constituent components of tobacco products.' The FDA will work with CDC scientists to investigate the safety of those ingredients." This is because the agency "also is considering bans on menthol cigarettes and other flavored tobacco," the Los Angeles Times (9/23, Hirsch) reports.

The AP (9/23, Felberbaum) notes that a law signed in June "allows the FDA to regulate the industry. Its authority includes the ability to ban certain products, reduce nicotine in tobacco products and block labels such 'low tar' and 'light.'" Tobacco companies also will be required to cover their cartons with large, graphic warnings. AFP (9/23) also covers the story.

Originally posted at InjuryBoard by Wayne Parsons

Zonulin Research Key To Cures For Autoimmune Disorders Like MS

Wayne Parsons — Tue, 08 Sep 2009 02:00:56 GMT

Make a note: zonulin _ a mysterious human protein _ is a molecule in the human body called haptoglobin 2 precursor. According to a science news story University of Maryland researchers have found that Zonulin is an immature state (or precursor) to another molecule - haptoglobin 2 - That may lead to cures for a variety of autoimmune diseases including multiple sclerosis.

University of Maryland School of Medicine researchers discovered that zonulin is a key to celiac disease and other autoimmune disorders, such as multiple sclerosis and diabetes in 2000. Alessio Fasano, M.D., and a team of researchers may be on the verge of a huge medical revolution.

Identifying the structure of the zonulin molecule will allow researchers around the world to better analyze how zonulin relates to most inflammatory disorders. Dr. Fasano published the study on September 7, 2009 in the Online version of the Proceedings of the National Academy of Sciences. Dr. Fasano is a professor of pediatrics, medicine and physiology and director of the Mucosal Biology Research Center and the Center for Celiac Research at the University of Maryland School of Medicine.

The haptoglobin molecule has been known for many years as a marker of inflammation in the body. The original form is now called Haptoglobin 1 which evolved 800 million years ago and then through mutation haptoglobin 2 showed up in humans (only humans) in India about 2 million years ago, spreading gradually among increasing numbers of people throughout the world.

Dr. Fasano's study found zonulin to be is the precursor molecule for haptoglobin 2 — that is, it is an immature molecule that matures into haptoglobin 2. Precursor molecules have also been known for some time but were thought to serve no purpose in humans other than to mature into their end molecules. Dr. Fasano found that zonulin opens a pathway in the intestine that allows gluten to enter. Celiac disease involves sensitivity to gluten. The Science Daily quotes Dr. Fasano:

"While apes, monkeys and chimpanzees do not have haptoglobin 2, 80 percent of human beings have it," says Dr. Fasano. "Apes, monkeys and chimpanzees rarely develop autoimmune disorders. Human beings suffer from more than 70 different kinds of such conditions. We believe the presence of this pre-haptoglobin 2 is responsible for this difference between species."

"This molecule could be a critical missing piece of the puzzle to lead to a treatment for celiac disease, other autoimmune disorders and allergies and even cancer, all of which are related to an exaggerated production of zonulin/pre-haptoglobin 2 and to the loss of the protective barrier of cells lining the gut and other areas of the body, like the blood brain barrier," says Dr. Fasano.

"The only current treatment for celiac disease is cutting gluten from the diet, but we have confidence Dr. Fasano's work will someday bring further relief to these patients. Zonulin, with its functions in health and disease as outlined in Dr. Fasano's paper, could be the molecule of the century," says E. Albert Reece, M.D., Ph.D., M.B.A., dean of the School of Medicine, vice president for medical affairs of the University of Maryland and John Z. and Akiko K. Bowers Distinguished Professor. Dr. Fasano, as a physician scientist, fulfills two of the core missions of the University of Maryland School of Medicine: making basic science discoveries that can impact human health, and finding ways to translate those discoveries into treatments and diagnostic tools."

Celiac disease is an over sensitivity to gluten, a protein found in wheat. Gluten causes a large release of zonulin which in turn makes the intestine permeable to large molecules, including gluten. Giving gluten access to the rest of the body turns on an autoimmune response in which the immune system sees gluten as an intruder and attacks the intestine rather than the gluten. Zonulin also seems responsible for the passage through the intestine of other intruders including those related to diabetes, multiple sclerosis and allergies. Zonulin is reported in other studies to implicate the permeability of the blood brain barrier in patients suffering from brain cancer. Senator Ted Kennedy suffered from primary brain cancer.

"We hope pre-haptoglobin 2 will be a door to a better understanding of not just celiac disease, but of several other devastating conditions that continue to affect the quality of life of millions of individuals," says Dr. Fasano. "This is quite a remarkable molecule that was just flying under the radar. We would have never have thought it would be the key. Now that we have identified this molecule, we are able to replicate it in the lab to use for research purposes. We hope to learn much more about it and its potential for treating and diagnosing celiac disease and other autoimmune conditions. This molecule has opened innumerable doors for our research."

Adapted from materials provided by University of Maryland Medical Center.

Originally posted at InjuryBoard by Wayne Parsons

Dialysis Risk: Does Your Doctor Know About Warfarin Causing Strokes?

Wayne Parsons — Sat, 05 Sep 2009 19:44:18 GMT

Warfarin (also marketed as Coumadin, Jantoven, Marevan, Lawarin, and Waran) first hit the market in 1948. Back then, though, it was not an anticoagulant; it was rat poison. It didn’t take long for scientists to uncover its therapeutic effects, and by the 1950’s it was prescribed by doctors to patients at risk for strokes. For the past fifty years, researchers have found undesired side effects. For pregnant women, Warfarin can cause bleeding in the fetus and stillbirths; for everyone else, it can catalyze hemorrhages, osteoporosis, and purple toe syndrome. Recently, another unsettling drug interaction has come to light. It is possible that, for those on dialysis, Warfarin can actually increase the risk of strokes.

If you are on dialysis and taking Warfarin, immediately ask your doctor about this risk.

Scientifically speaking, Warfarin is most often prescribed to patients with atrial fibrillation, a common type of abnormal heart rhythm. To study the effect of Warfarin on atrial fibrillation patients who are also on dialysis, a cohort of medics from Fresenius Medical Care North America and Massachusetts General Hospital followed almost 1,700 patients for more than one and a half years. Their findings suggest that Warfarin increases the risk of stroke for dialysis patients. Interestingly, they found no similar correlation for two other blood thinners, clopidogrel and aspirin). In a story in TheHeart.org:

Boston, MA - A contemporary assessment of the real-world clinical care of patients with atrial fibrillation (AF) has identified those who will gain the most benefit from taking Warfarin therapy [1]. Dr Daniel E Singer (Massachusetts General Hospital, Boston, MA) and colleagues report their findings, taken from the Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) cohort, in the September 1, 2009 issue of the Annals of Internal Medicine.

Existing guidelines for Warfarin therapy are based on "old data—randomized clinical trials completed in the 1990s, for the most part," Singer explained to heartwire, "and they don't completely take into consideration the risk of intracranial hemorrhage [ICH]. We were looking to see, 'What is the net benefit of warfarin?'—the good things, ie, a reduction in clot strokes—vs the bad things, ie, increased bleeding into and around the brain."

They found that the net benefit of Warfarin was highest among patients with the highest untreated risk for stroke, because the absolute increase in risk for ICH due to Warfarin remains fairly stable across thromboembolic risk categories. These included those with a history of ischemic stroke and those in the highest CHADS₂ category (where patients score 1 point each for congestive heart failure, hypertension, age, and diabetes and 2 points for stroke). Those with a CHADS₂ score of 0 or 1 gained no benefit from Warfarin, with net benefit being seen in those with a CHADS₂ score of 2 or greater.
We can't go out and anticoagulate everyone over 85, but if you think they are reasonable candidates, the data suggest they will benefit.
Notably, the benefit was greater the older the patient, Singer said, so one of the important messages of this study is that age should not be a barrier to Warfarin treatment, as long as the patient "is not falling and is not terribly demented. We can't go out and anticoagulate everyone over 85, but if you think they are reasonable candidates, the data suggest they will benefit."

It’s important to remember, though, that these results are only preliminary. Further, randomized investigations are necessary, as well as thorough evaluations of other possible causes for the increased stroke rate. This study is not a reason to panic; it’s a reason to determine more thoroughly the effect Warfarin has on our bodies.

If you are worried about Warfarin, talk to your doctor about it. If it was prescribed to you, then the benefits probably outweigh the risks.

Originally posted at InjuryBoard by Wayne Parsons

The Potential Impact of Human Papillomavirus Vaccination on Hawaii Women

Wayne Parsons — Tue, 18 Aug 2009 03:56:03 GMT

My preference for cancer is to start with what we know. Knowing something is not hearing something or reading something. It is understanding.

Here are the facts about the effect of HPV vaccination on young girls. You should read it if you are serious about cervical cancer, as I am:

The aim of this study was to determine the proportion of invasive cervical cancers attributable to human papillomavirus (HPV) types 16 and 18 in a contemporary, cytologically well-screened UK population. This was achieved in a retrospective observational analysis by HPV typing 453 archival invasive cervical cancers diagnosed between January 1, 2000 and September 1, 2006. Pathological material was collected from 9 hospitals across Wales (UK), and HPV typing and pathology review was conducted at a central laboratory. Genotyping for high-risk HPV DNA was performed by PCR-enzyme immunoassay using the GP5+/6+ primer set. DNA was successfully extracted from 297 cases. Two hundred and eighty cases were included in the final analysis. The proportion of cases which had only HPV 16 and/or 18 was 219 of 280 (78.2%, 95% CI = 73.0-82.7); the proportion of cases which had HPV 16 or 18 and another HPV type was 230 of 280 (82.1%, 95% CI = 77.2-86.2). The proportion of cervical cancers associated with infection with HPV types 16 and 18 has previously been estimated at around 70%. The appropriate figure for a cytologically well-screened UK population appears to be approximately 80%. Hence, the potential impact of the current vaccination programme may be underestimated. © 2009 UICC

That is the science. The evidence says that 80% of the girls vaccinated for HPV will benefit. That means less cervical cancer.

Originally posted at InjuryBoard by Wayne Parsons

FDA finalizes rules allowing patients greater access to experimental drugs.

Wayne Parsons — Sun, 16 Aug 2009 01:47:57 GMT

Bloomberg News (8/13, Randall) reports that new regulations posted on the FDA's website Wednesday will grant seriously ill patients "greater access to experimental drugs." The FDA said the rules "let drugmakers give or sell experimental medicines to patients who have no other options, including in emergencies." The rules, which were proposed in December 2006, also "clarify existing programs for providing novel medicines through clinical trials and expand drug access to additional groups of patients...and may provide experimental drugs to as many as 3,095 more patients each year, the agency said."

The Wall Street Journal (8/13, Dooren) also reports that the regulations will let patients know how they can receive drugs in development and outside of clinical trials. FDA Commissioner Margaret A. Hamburg said, "With these initiatives, patients will have the information they need to help them decide whether to seek investigational products." One of the rules also allows companies and researchers to charge patients for the experimental drugs.

CQ HealthBeat (8/13, Attias) notes that Joseph P. Griffin, "regulatory counsel of the Office of Medical Policy in FDA's Center for Drug Evaluation and Research," explained that "to charge for a drug during a clinical trial, however, the company must show that the drug has potential clinical benefit compared to the current therapy available, that the study is essential to approving the drug and that the cost of the drug is extraordinary." Both of the regulations "will go into effect in 60 days."

Originally posted at InjuryBoard by Wayne Parsons

GIFT15 - Is A Cure For Multiple Sclerosis On The Horizon?

Wayne Parsons — Thu, 13 Aug 2009 21:49:11 GMT

McGill University researchers in Canada have announced that _ in mice _ they may have found a way to treat and cure multiple sclerosis (MS). In animals they can reverse the devastating disease with a new treatment that suppresses the immune system and forces MS into remission.

Will the treatment work equality well in humans? Let's hope so! Our wishes for success go out to researchers at the Jewish General Hospital Lady Davis Institute for Medical Research and McGill University in Montreal.

MS is an autoimmune disease in which the immune system attacks the central nervous system. This attack causes physical and cognitive disability that progresses over time. According to the news out of McGill new combination of two proteins stops this process:

The new treatment, appropriately named GIFT15, puts MS into remission by suppressing the immune response. This means it might also be effective against other autoimmune disorders like Crohn's disease, lupus and arthritis, the researchers said, and could theoretically also control immune responses in organ transplant patients. Moreover, unlike earlier immune-suppressing therapies which rely on chemical pharmaceuticals, this approach is a personalized form of cellular therapy which utilizes the body's own cells to suppress immunity in a much more targeted way.

Dr. Jacques Galipeau of the JGH Lady Davis Institute and McGill's Faculty of Medicine discovered GIFT15. The news shook the world of science and raised the hopes of the patients who suffer from MS when it was published on August 9, 2009 in the journal Nature Medicine.

GIFT15 is 2 proteins, GSM-CSF and interleukin-15, combined in the laboratory. Individually each protein normally stimulates the immune system. Together however they suppress the immune system.

"You know those mythical animals that have the head of an eagle and the body of a lion? They're called chimeras. In a lyrical sense, that's what we've created," said Galipeau, a world-renowned expert in cell regeneration affiliated with the Segal Cancer Centre at the Jewish General and McGill's Centre for Translational Research. "GIFT15 is a new protein hormone composed of two distinct proteins, and when they're stuck together they lead to a completely unexpected biological effect."

Together as GIFT15 they change B-cells -- a common form of white blood cell normally involved in immune response -- into powerful immune-suppressive cells. Unlike their better-known cousins, T-cells, naturally-occurring immune-suppressing B-cells are almost unknown in nature and the notion of using them to control immunity is very new.

"GIFT15 can take your normal, run-of-the-mill B-cells and convert them -- in a Superman or Jekyll -Hyde sort of way -- into these super-powerful B-regulatory cells," Galipeau explained. "We can do that in a petri dish. We took normal B-cells from mice, and sprinkled GIFT15 on them, which led to this Jekyll and Hyde effect.

"And when we gave them back intravenously to mice ill with multiple sclerosis, the disease went away."

To effectively treat multiple sclerosis it must be attacked as early as possible. Of course human trials to study safety and efficacy are needed now. In the current animal studies side effects were non-existent.

Impressively the treatment was fully effective in a single dose of GIFT15.

"It's easy to collect B-cells from a patient," he added. "It's just like donating blood. We purify them in the lab, treat them with GIFT15 in a petri dish, and give them back to the patient. That's what we did in mice, and that's what we believe we could do in people. It would be very easy to take the next step, it's just a question of finding the financial resources and partnerships to make this a reality."

PLEASE NOTE: DR. GALIPEAU IS AVAILABLE FOR MEDIA INTERVIEWS ONLY AS OF WED., AUGUST 12.

Contact: Mark Shainblum
mark.shainblum@mcgill.ca
514-398-2189

Originally posted at InjuryBoard by Wayne Parsons

Merck, Schering agree to $41.5 million settlement of Vytorin, Zetia suits.

Wayne Parsons — Thu, 06 Aug 2009 17:26:55 GMT

The New York Times (8/6, B4, Shih) reports, "Merck and Schering-Plough agreed Wednesday to pay $41.5 million to settle class-action lawsuits that accused them of withholding unfavorable results of a clinical trial of the cholesterol drugs Vytorin [ezetimibe and simvastatin] and Zetia [ezetimibe]." In January 2008, the companies "released a study -- completed nearly two years earlier -- that showed that the medicines, the work of a joint venture, were no more effective in unclogging arteries than a pre-existing and less expensive cholesterol treatment." The agreement "resolves more than 140 claims filed by consumers and insurers who bought, used or paid money toward the purchase of Vytorin and Zetia."

The Wall Street Journal (8/6, Loftus) reports, "Some suits alleged the drugs caused personal injuries, or sought a court order that the companies pay for medical monitoring of users and drugs." For their part, "the companies have said data-quality problems with the study required repeated analyses, and that top company officials didn't know the results until shortly before they were released." Merck and Schering also "agreed to pay $5.4 million and comply with certain rules" last month, settling "a probe by 35 US states and the District of Columbia into whether their handling of the...study violated consumer-protection laws."

But, the companies "did not acknowledge any wrongdoing or liability as part of the settlement," the AP (8/5, Johnson) reported. Bruce N. Kuhlik, executive vice president and general counsel at Merck, noted that "these agreements will allow the companies to avoid continuing defense costs and remain focused on discovering, developing, and delivering novel medicines and vaccines." Currently, "Merck is in the midst of a $41.1 billion buyout of" Schering in a deal that is "set to close in the fourth quarter."

Originally posted at InjuryBoard by Wayne Parsons