By Cathy O’Neil, a data scientist who lives in New York City and writes at
mathbabe.org
Yesterday I caught a lecture at Columbia given by statistics professor
David Madigan, who explained to us the story of
Vioxx and
Merck. It’s fascinating and I was lucky to get permission to retell it here.
Disclosure
Madigan has been a paid consultant to work on litigation against Merck. He doesn’t consider Merck to be an evil company by any means, and says it does lots of good by producing medicines for people. According to him, the following Vioxx story is “a line of work where they went astray”.
Yet Madigan’s own data strongly suggests that Merck was well aware of the fatalities resulting from Vioxx, a blockbuster drug that earned them $2.4b in 2003, the year before it “voluntarily” pulled it from the market in September 2004. What you will read below shows that the company set up standard data protection and analysis plans which they later either revoked or didn’t follow through with, they gave the FDA misleading statistics to trick them into thinking the drug was safe, and set up a biased filter on an Alzheimer’s patient study to make the results look better. They hoodwinked the FDA and the New England Journal of Medicine and took advantage of the public trust which ultimately caused the deaths of thousands of people.
The data for this talk came from published papers, internal Merck documents that he saw through the litigation process, FDA documents, and SAS files with primary data coming from Merck’s clinical trials. So not all of the numbers I will state below can be corroborated, unfortunately, due to the fact that this data is not all publicly available. This is particularly outrageous considering the repercussions that this data represents to the public.
Background
The process for getting a drug approved is lengthy, requires three phases of clinical trials before getting FDA approval, and often takes well over a decade. Before the FDA approved Vioxx, less than 20,000 people tried the drug, versus 20,000,000 people after it was approved. Therefore it’s natural that rare side effects are harder to see beforehand. Also, it should be kept in mind that for the sake of clinical trials, they choose only people who are healthy outside of the one disease which is under treatment by the drug, and moreover they only take that one drug, in carefully monitored doses. Compare this to after the drug is on the market, where people could be unhealthy in various ways and could be taking other drugs or too much of this drug.
Vioxx was supposed to be a new “
NSAID” drug without the bad side effects. NSAID drugs are pain killers like
Aleve and
ibuprofen and
aspirin, but those had the unfortunate side effects of gastro-intestinal problems (but those are only among a subset of long term users, such as people who take painkillers daily to treat chronic pain, such as people with advanced arthritis . The goal was to find a pain-killer without the GI side effects. The underlying scientific goal was to find a
COX-2 inhibitor without the
COX-1 inhibition, since scientists had realized in 1991 that COX-2 suppression corresponded to pain relief whereas COX-1 suppression corresponded to GI problems.
Vioxx Introduced and Withdrawn From the Market
The timeline for Vioxx’s introduction to the market was accelerated: they started work in 1991 and got approval in 1999. They pulled Vioxx from the market in 2004 in the “best interest of the patient”. It turned out that it caused heart attacks and strokes. The stock price of Merck plummeted and $30 billion of its market cap was lost. There was also an avalanche of lawsuits, one of the largest resulting in a $5 billion settlement which was essentially a victory for Merck, considering they made a profit of $10 billion on the drug while it was being sold.
The story Merck will tell you is that they “voluntarily withdrew” the drug on September 30, 2004. In a placebo-controlled study of colon polyps in 2004, it was revealed that over a time period of 1200 days, 4% of the Vioxx users suffered a “cardiac, vascular, or thoracic event” (CVT event , which basically means something like a heart attack or stroke, whereas only 2% of the placebo group suffered such an event. In a group of about 2400 people, this was statistically significant, and Merck had no choice but to pull their drug from the market.
It should be noted that, on the one hand Merck should be applauded for checking for CVT events on a colon polyps study, but on the other hand that in 1997, at the International Consensus Meeting on COX-2 Inhibition, a group of leading scientists issued a warning in their Executive Summary that it was “… important to monitor cardiac side effects with selective COX-2 inhibitors”. Moreover, in an internal Merck email as early as 1996, it was stated there was a “… substantial chance that CVT will be observed.” In other words, Merck knew to look out for such things. Importantly, however, there was no subsequent insert in the medicine’s packaging that warned of possible CVT side-effects.
What the CEO of Merck Said
What did Merck say to the world at that point in 2004? You can look for yourself at
the four and half hour Congressional hearing (seen on C-SPAN which took place on November 18, 2004. Starting at 3:27:10, the then-CEO of Merck,
Raymond Gilmartin, testifies that Merck “puts patients first” and “acted quickly” when there was reason to believe that Vioxx was causing CVT events. Gilmartin also went on the Charlie Rose show and repeated these claims, even go so far as stating that the 2004 study was
the first time
they had a study which showed evidence of such side effects.
How quickly
did
they really act though? Were there warning signs before September 30, 2004?
Arthritis Studies
Let’s go back to the time in 1999 when Vioxx was FDA approved. In spite of the fact that it was approved for a rather narrow use, mainly for arthritis sufferers who needed chronic pain management and were having GI problems on other meds (keeping in mind that Vioxx was way more expensive than ibuprofen or aspirin, so why would you use it unless you needed to , Merck nevertheless launched an
ad campaign with Dorothy Hamill and spent $160m (compare that with Budweiser which spent $146m or Pepsi which spent $125m in the same time period .
As I mentioned, Vioxx was approved faster than usual. At the time of its approval, the completed clinical studies had only been 6- or 12-week studies; no longer term studies had been completed. However, there was one underway at the time of approval, namely a study which compared Aleve with Vioxx for people suffering from
osteoarthritis and
rheumatoid arthritis.
What did the arthritis studies show? These results, which were available in late 2003, showed that the CVT events were more than twice as likely with Vioxx as with Aleve (CVT event rates of 32/1304 = 0.0245 with Vioxx, 6/692 = 0.0086 with Aleve, with a p-value of 0.01 . As we see this is a direct refutation of the fact that CEO Gilmartin stated that they didn’t have evidence until 2004 and acted quickly when they did.
In fact they had evidence even before this, if they bothered to put it together (in fact they stated a plan to do such statistical analyses but it’s not clear if they did them- or in any case there’s so far no evidence that they actually did these promised analyses .
In a previous study (“Table 13? , available in February of 2002, the could have seen that, comparing Vioxx to placebo, we saw a CVT event rate of 27/1087 = 0.0248 with Vioxx versus 5/633 = 0.0079 with placebo, with a p-value of 0.01. So, three times as likely.
In fact, there was an even earlier study (“1999 plan” , results of which were available in July of 2000, where the Vioxx CVT event rate was 10/427 = 0.0234 versus a placebo event rate of 1/252 = 0.0040, with a p-value of 0.05 (so more than 5 times as likely . This p-value can be taken to be the definition of statistically significant. So actually they knew to be very worried as early as 2000, but maybe they… forgot to do the analysis?
The FDA and Pooled Data
Where was the FDA in all of this?
They showed the FDA some of these numbers. But they did something really tricky. Namely, they kept the “osteoarthritis study” results separate from the “rheumatoid arthritis study” results. Each alone were not quite statistically significant, but together were amply statistically significant. Moreover, they introduced a third category of study, namely the “Alzheimer’s study” results, which looked pretty insignificant (more on that below though . When you pooled all three of these study types together, the overall significance was just barely not there.
It should be mentioned that there was no apparent reason to separate the different arthritic studies, and there is evidence that they did pool such study data in other places as a standard method. That they didn’t pool those studies for the sake of their FDA report is incredibly suspicious. That the FDA didn’t pick up on this is probably due to the fact that they are overworked lawyers, and too trusting on top of that. That’s unfortunately not the only mistake the FDA made (more below .
Alzheimer’s Study
So the Alzheimer’s study kind of “saved the day” here. But let’s look into this more. First, note that the average age of the 3,000 patients in the Alzheimer’s study was 75, it was a 48-month study, and that the total number of deaths for those on Vioxx was 41 versus 24 on placebo. So actually on the face of it it sounds pretty bad for Vioxx.
There were a few contributing reasons why the numbers got so mild by the time the study’s result was pooled with the two arthritis studies. First, when really old people die, there isn’t always an autopsy. Second, although there was supposed to be a
DSMB as part of the study, and one was part of the original proposal submitted to the FDA, this was dropped surreptitiously in a later FDA update. This meant there was no third party keeping an eye on the data, which is
not
standard operating procedure for a massive drug study and was a major mistake, possibly the biggest one, by the FDA.
Third, and perhaps most importantly, Merck researchers created an added “filter” to the reported CVT events, which meant they needed the doctors who reported the CVT event to send their info to the Merck-paid people (“investigators” , who looked over the documents to decide whether it was a bonafide CVT event or not. The default was to assume it wasn’t, even though standard operating procedure would have the default assuming that there was such an event. In all, this filter removed about half the initially reported CVT events, and about twice as often the Vioxx patients had their CVT event status revoked as for the placebo patients. Note that the “investigator” in charge of checking the documents from the reporting doctors is paid $10,000 per patient. So presumably they wanted to continue to work for Merck in the future.
The effect of this “filter” was that, instead of it seeming 1.5 times as likely to have a CVT event if you were taking Voixx, it seemed like it was only 1.03 as likely, with a high p-score.
If you remove the ridiculous filter from the Alzheimer’s study, then you see that as of November 2000 there was statistically significant evidence that Vioxx caused CVT events in Alzheimer patients.
By the way, one extra note. Many of the 41 deaths in the Vioxx group were dismissed as “bizarre” and therefore unrelated to Vioxx. Namely, car accidents, falling of ladders, accidentally eating bromide pills. But at this point there’s evidence that Vioxx actually accelerates Alzheimer’s disease itself, which could explain those so-called bizarre deaths. This is not to say that Merck knew that, but rather that one should not immediately dismiss the concept of statistically significant just because it doesn’t make intuitive sense.
VIGOR and the New England Journal of Medicine
One last chapter in this sad story. There was a large-scale study, called the VIGOR study, with 8,000 patients. It was published in the
New England Journal of Medicine on November 23, 2000. See also this
NPR timeline for details. They didn’t show the graphs which would have emphasized this point, but they admitted, in a deceptively round-about way, that Vioxx has 4 times the number of CVT events than Aleve. They hinted that this is either because Aleve is protective against CVT events or that Vioxx is bad for it, but left it open.
But Bayer, which owns Aleve, issued a press release saying something like, “if Aleve is protective for CVT events then it’s news to us.” Bayer, it should be noted, has every reason to want people to think that Aleve is protective against CVT events. This problem, and the dubious reasoning explaining it away, was completely missed by the peer review system; if it had been spotted, Vioxx would have been forced off the market then and there. Instead, Merck purchased 900,000 preprints of this article from the NE Journal of Medicine, which is more than the number of practicing doctors in the U.S.. In other words, the Journal was used as a PR vehicle for Merck.
The paper emphasized that Aleve has twice the rate of ulcers and bleeding, at 4%, whereas Vioxx had a rate of only 2% among chronic users. When you compare that to the elevated rate of heart attack and death (0.4% to 1.2% of Vioxx over Aleve, though, the reduced ulcer rate doesn’t seem all that impressive.
A bit more color on this paper. It was written internally by Merck, after which non-Merck authors were found. One of them is Loren Laine. Loren helped Merck develop a sound-byte interview which was 30 seconds long and was sent to the news media and run like a press interview, even though it actually happened in Merck’s New Jersey office (with a backdrop to look like a library with a Merck employee posing as a neutral interviewer. Some smart lawyer got the outtakes of this video made available as part of the litigation against Merck. Check out this
youtube video, where Laine and the fake interviewer scheme about spin and Laine admits they were being “cagey” about the renal failure issues that were poorly addressed in the article.
The Damage Done
Also on the
Congress testimony I mentioned above is Dr. David Graham, who speaks passionately from minute 41:11 to minute 53:37 about Vioxx and how it is a symptom of a broken regulatory system. Please take 10 minutes to listen if you can.
He claims a conservative estimate is that 100,000 people have had heart attacks as a result of using Vioxx, leading to between 30,000 and 40,000 deaths (again conservatively estimated . He points out that this 100,000 is 5% of Iowa, and in terms people may understand better, this is like 4 aircraft falling out of the sky every week for 5 years.
According to
this blog, the noticeable downwards blip in overall death count nationwide in 2004 is probably due to the fact that Vioxx was taken off the market that year.
Conclusion
Let’s face it, nobody comes out looking good in this story. The peer review system failed, the FDA failed, Merck scientists failed, and the CEO of Merck lied to Congress and to the people who had lost their husbands and wives to this damaging drug. The truth is, we’ve come to expect this kind of behavior from traders and bankers, but here we’re talking about issues of death and quality of life on a massive scale, and we have people playing games with statistics, with academic journals, and with the regulators.
Just as the financial system has to be changed to serve the needs of the people before the needs of the bankers, the drug trial system has to be changed to lower the incentives for cheating (and massive death tolls just for a quick buck. As I mentioned before, it’s still not clear that they would have made less money, even including the penalties, if they had come clean in 2000. They made a bet that the fines they’d need to eventually pay would be smaller than the profits they’d make in the meantime. That sounds familiar to anyone who has been following the fallout from the credit crisis.
One thing that should be changed immediately: the clinical trials for drugs should not be run or reported on by the drug companies themselves. There has to be a third party which is in charge of testing the drugs and has the power to take the drugs off the market immediately if adverse effects (like CVT events are found. Hopefully they will be given more power than risk firms are currently given in finance (which is none - in other words, it needs to be more than reporting, it needs to be an active regulatory power, with smart people who understand statistics and do their own state-of-the-art analyses – although as we’ve seen above even just Stats 101 would sometimes do the trick.
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February 14, 2012
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AMERICA'S Food and Drug Administration (FDA
announced late on February 14th that 19 medical practices had bought counterfeit Avastin, a popular cancer drug. The doctors and hospitals bought the bum drug from a foreign supplier, Quality Specialty Products.
As such scares go, this one could have been worse. Avastin, marketed in America by
Genentech, is an injected drug available only in hospitals and doctors’ offices. Presumably health professionals will spot rogue bottles more quickly than the average consumer would have. So far there have been no reports of dangerous reactions, unlike some past incidents—in 2008 a sham bloodthinner made in China killed several Americans and sickened many more.
But the news is alarming nonetheless. It is another reminder of how vulnerable the drug supply-chain remains. About 80% of ingredients for drugs bought in America are made elsewhere. Imports of drugs have grown by nearly 13% a year. Regulators have
done their best to keep up. The FDA has opened a series of offices abroad; inspections of foreign factories increased by 27% from 2007 to 2009. It is trying to foster
collaboration with foreign regulators—apparently Britain’s Medicines and Healthcare Products Regulatory Agency alerted the FDA to the counterfeit Avastin. More changes are on the way. Generic drug companies have agreed to pay the FDA a fee to increase foreign inspections, a deal that must still be approved by Congress. The FDA is also
asking the government for more money to expand its operations in China. But change, as the recent fiasco proves, is not coming fast enough.
Food industry stakeholders were closely watching for details on the president's request for FDA because the agency, which oversees 80 percent of the food supply, is rolling out the one-year-old Food Safety Modernization Act, an initiative the Congressional Budget Office estimates will cost $1.4 billion over five years to implement.
For FY 2012, the FDA ended up receiving a $50 million boost, in large part to help fund food safety -- a somewhat miraculous feat in a tough budgetary environment. Under the Obama budget plan, FDA's discretionary budget would be essentially frozen at current levels for FY 2013, at $2.5 billion.
The plan calls for a $253 million increase for food safety, $220 million of which would come from industry fees. The request also seeks $10 million to improve FDA's cooperation with and capacity in China.
"The end result is that agencies like the FDA are more and more dependent on user fees raised by some of the same industries they oversee,"
Politico noted Friday. Forty-four percent of Obama's $4.5 billion request for FDA comes from various fees.
It is not clear what types of food facilities would pay fees, or whether the fees would extend to farms. The details have not yet been worked out, according to Patrick McGarey, Assistant Commissioner for Budget at FDA.
"This is a situation where we've characterized this as a food safety registration fee. The law defines who should register...that's a proposal that they're familiar with from years past," said McGarey, referring to the House version of the Food Safety Modernization Act, which did not become law.
"We're open to working with industry to shape a proposal that meets their objectives and our objectives and meets the public health needs of food safety," added McGarey. "We've not defined the registration fee yet as to which facility and at what amount the fee would be assessed."
"We're just open to alternative recommendations. If we're open minded about it, we get some constructive and creative proposals," he said. "We're eager to get comments and feedback from stakeholders."
What is clear is that a broad coalition of food industry groups
are vehemently opposed to food safety fees.
"Imposing new user fees on food makers is the wrong option for supporting food safety programs as businesses can ill afford new cost burdens, which ultimately would represent a new food safety tax on consumers," read an industry letter sent to the so-called supercommittee in October.
The Alliance for a Stronger FDA, a coalition of industry and consumer groups, reacted to the proposal with concern because it relies too heavily on fees.
"The FDA's essential role in protecting public health continues to grow to meet the demands of our time. With no other agency as fallback, we believe that FDA's funding should be increased to reflect the agency's vast responsibilities and increased workload," said Margaret Anderson, president of the Alliance and executive director of FasterCures. "Inadequate funding for the FDA has real and immediate consequences as it jeopardizes the public health."
"In this year of austerity, we appreciate that the President has proposed the same funding for FDA, even while many other agencies have been cut. However, this is not enough when the FDA mission is expanding and the agency is providing services and protections that Americans value," said Diane Dorman, of the National Organization for Rare Disorders, who serves as vice president of the Alliance.
Pharmaceutical giant, Johnson & Johnson, now faces thousands of
transvaginal mesh lawsuits by women who claim that transvaginal mesh causes complications and injuries. Transvaginal mesh is a surgical mesh that is generally used to repair weakened or damaged tissue. In urogynecologic procedures, surgical mesh is permanently implanted to reinforce the weakened vagina wall to repair pelvic organ prolapse (POP or to support the urethra to treat stress urinary incontinence (SUI .
According to the Food and Drug Administration, in 2010 there were at least 100,000 POP repairs that used surgical mesh, 75,000 of these was transvaginal procedures. Many of the women who have had the surgical mesh procedure say that they have experienced side effects such as infection, inflammation, scar tissue, pelvic pain, pelvic floor damage, and more.
On July 13, 2011, the FDA issued an updated safety communication warning health care providers and patients about the increasing concerns about the adverse events associated with transvaginal mesh, stating that surgical placement of mesh through the vagina to repair POP may expose patients to greater risk than other surgical options.
Women injured by surgical mesh make allegations that Johnson & Johnson underrepresented and withheld information about the tendency of the products to fail and cause injury and complications. It is also believed that Johnson & Johnson failed to properly test and research the surgical mesh to evaluate the risks and benefits associated with the surgical mesh.
As a result of the complications and injuries caused by surgical mesh implants, those women affected must now seek medical treatment. The FDA recommends that health care providers realize that
surgical mesh, in most cases, can be successfully treated without the need for a surgical mesh implant. Health care providers are also highly advised to only choose surgical mesh after all benefits and risks have been identified.
According to complaints received by the Food and Drug Administration (FDA ,
transvaginal mesh has been causing adverse effects to occur in thousands of women. Transvaginal Mesh is a surgical mesh that is generally used to repair weakened or damaged tissue. In urogynecologic procedures, surgical mesh is permanently implanted to reinforce the weakened vagina wall to repair pelvic organ prolapse (POP or to support the urethra to treat stress urinary incontinence (SUI .
Though the surgical mesh was designed to be beneficial; women who have had the surgery claim that side effects include infection, inflammation, scar tissue, pelvic pain, pelvic floor damage, and more.
Women who have been injured by the transvaginal mesh implants now require medical treatment to locate and remove the mesh and repair pelvic organs, tissue, and nerve damage caused by the mesh.
The FDA issued an updated safety communication on July 13, 2011, due to the increasing concerns about the adverse events associated with Transvaginal Mesh, warning health care providers and patients that surgical placement of mesh through the vagina to repair POP may expose patients to greater risk than other surgical options. According to the FDA, between 2008 and 2010, approximate 2,874 adverse events were reported.
A study was published in the Journal of the American College of Obstetricians and Gynecologists and concluded that there is a 15.6% vaginal mesh erosion rate with Prolift®, a type of surgical mesh, with no difference in overall objective and subjective cure rates.
Manufacturer Johnson & Johnson now faces
transvaginal mesh lawsuits from thousands of women who claim that the company underrepresented and withheld information about the tendency of the products to fail and cause injury and complications. Furthermore, it is believed that Johnson & Johnson failed to properly test and research the product to evaluate the risks and benefits associated with the surgical mesh.
The health care products giant Johnson & Johnson continued to market an artificial hip in Europe and elsewhere overseas after the Food and Drug Administration rejected its sale in the United States based on a review of company safety studies.During that period, the company also continued to sell in this country a related model, which earlier went on the market using a regulatory loophole that did not require a similar safety review.
It is not known how many people overseas received the replacement hip after the agency decided in 2009 not to approve it, nor the number who received the closely linked implant sold in this country. During some eight years on the market, the two implants were used in about 93,000 patients worldwide, about one-third of them in the United States. Both models were based on the same component, an all-metal hip socket cup that experts say was faulty in design.
The DePuy orthopedic division of Johnson & Johnson, citing declining sales, began phasing out both models of the device — formally known as an articular surface replacement device, which DePuy marketed under the name ASR — in November 2009 and formally recalled them in August 2010 amid reports in databases of orthopedic patients abroad showing they were failing prematurely at high rates.
But in a confidential letter, the F.D.A. told Johnson & Johnson in August 2009 that company studies and clinical data submitted to gain approval in the United States to sell the model available overseas were inadequate to determine the implant’s safety and effectiveness, according to a summary of the letter reviewed by The New York Times.
The agency also told the company it would need added clinical data to pursue the application, a process that would probably have taken a year or more. DePuy’s receipt of the notice came as regulators and surgeons abroad as well as doctors in this country were raising serious questions about growing failures of both models of the implant.
A spokeswoman for DePuy confirmed that the company had received the agency’s so-called nonapproval letter. But the spokeswoman, Mindy Tinsley, declined to release the letter or to respond to questions about when, or if, DePuy disclosed the ruling to doctors, patients, investors or regulators abroad.
A principal researcher on the clinical studies submitted by the company to the F.D.A. said he was not informed of the agency’s decision. Also, a review of publicly available information indicates that the company did not discuss the agency’s nonapproval letter in financial reports or in presentations to analysts while the device remained on the market.
There is no suggestion that Johnson & Johnson broke the law. Regulatory standards in other countries, like those in Europe, for approving the sale of medical devices are typically lower than here. A spokeswoman for a British regulatory agency, the Medicines and Healthcare Products Regulatory Agency, said that companies like Johnson & Johnson were not required to notify it when the F.D.A. refused to approve a product that was used in patients there.
However, the F.D.A.’s rejection may further deepen the company’s legal and financial problems surrounding the ASR. Last month, the company took a special $3 billion charge, much of it related to anticipated legal and medical expenses associated with the recall. An estimated 5,000 lawsuits involving the device are pending, including some from patients crippled by tiny particles of metallic debris shed by the implants.
William Vodra, a lawyer who specializes in F.D.A. regulation, said that, in general, drug and medical device makers typically disclose nonapproval letters if they might have a material impact on a company’s finances. Mr. Vodra added that apart from that financial calculation, there was no hard-and-fast rule about making such rulings public.
Mr. Vodra said that if a company decided to withhold a nonapproval letter that contained important safety information about a device used by doctors, it could face damage to its brand. “They have to think long and hard of the reputational impact,” he said.
The handling of the ASR highlights how the F.D.A., by keeping its approval process confidential, may affect the health and safety of patients. An agency spokesman, Morgan Liscinsky, declined to disclose the letter on the ASR, saying the agency had a policy of not releasing such notices because they might contain confidential business information.
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Former FDA commissioner Andrew von Eschenbach calls on the agency to abandon efficacy testing for new drug and device applications and leave those concerns to post-marketing studies.
MASSDEVICE ON CALL — Former FDA commissioner Andrew von Eschenbach turned heads yesterday by calling on the federal watchdog agency to abandon efficacy testing when considering new drug and device applications.
Eschenbach, who led the agency from 2006 to 2009, called for an overhaul of the FDA's mission statement and urged Congress to leverage user fee negotiations to reassess the agency's performance.
Clinical Trials,
510(k reforms,
Cardiac Rhythm Management,
Medical Device Tax,
Recalls,
Wall Street Beat,
Warning Letter
The Missouri Department of Health and Senior Services received the following recall regarding RegenArouse, Lot Number 130100, because of the presence of Tadalafil making these products unapproved new drugs. Tadalafil is an FDA-approved drug used as treatment for male Erectile Dysfunction. The active drug ingredient is not listed on the label for these products.
RegenArouse, Lot Number 130100, is a pink capsule sold individually in foil packets, with the expiration date of 12/5/2013 and a UPC code of 816860010079.
Use of these products may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin and may lower blood pressure to dangerous levels.
Regeneca, Inc. has distributed RegenArouse via sales made over the internet to consumers in the United States of America and Puerto Rico between November 29, 2011 and February 10, 2012.
The full recall announcement can be found at:
www.fda.gov/Safety/Recalls/ucm291546.htm?source=govdelivery.
recently tested the top 400 lipsticks and found that all of them contain trace amounts of lead. Among the top 10 contaminated brands five are Maybelline and L’Oreal, owned by L’Oreal USA, two Cover Girl, two NARS lipsticks, and one from Stargazer, according to the FDA’s data. The lipstick with the highest concentration of lead was Maybelline’s Color Sensational “Pink Petal” with a concentration of 7.19 parts per million. But the average concentration out of the 400 lipsticks tested was 1.11 parts per million, well below the proposed limit of 10 parts per million. The Campaign for Safe Cosmetics raised concerns to the FDA urging them to set limits to the amount of lead allowable in cosmetic products. In 2007 the campaign tested 33 lipsticks and found two-thirds of them contained lead and one-third surpassed the FDA’s lead limit for candy, according to TheSpec.com. But the FDA finds no comparison to candy and lipstick saying, “It is not scientifically valid to equate the risk to consumers presented by lead levels in candy, a product intended for ingestion, with that associated with lead levels in lipstick, a product intended for topical use and ingested in much smaller quantities than candy.” According to the Halyna Breslawec the chief scientist for the Personal Care Products Council, the trade group representing cosmetics manufacturers, lead is not added to the lipstick but is contained in trace amounts due to the minerals used for the colors. The lead is naturally found in the soil, water and air. Regulation of lead in lipsticks has proven to be difficult. In California, they have laws requiring companies to report chemicals known to cause cancer or cause reproductive harm, But the trace amounts of lead in the products are not high enough to trigger the warnings. The warnings are only triggered when the concentration reaches 5 parts per million. Only two lipsticks exceeded the limit for the warning out of the 400 tested, Maybelline’s “Pink Petal” and L’Oreals’s Colour Riche “Volcanic” lipstick. --- On the Net:
A new study, published in the Journal of the American College of Cardiology, compared the
side effects of Pradaxa use and Warfarin. Both medications are considered anticoagulants, or blood thinners, and are typically prescribed to treat non-valvular atrial fibrillation, a condition in which the heart does not beat properly.
The purpose of the study was to determine if Pradaxa could be used as a blood thinning medication for patients diagnosed with atrial fibrillation. About 290 people were involved in the study, half of whom received Pradaxa while the other half received warfarin.
The researchers from the University of Kansas Hospital and Medical Center state that the group of Pradaxa users faced a higher risk for experiencing adverse side effects including bleeding problems, stroke, and mini strokes than warfarin users. According to the study Pradaxa users had a 16% higher risk
Pradaxa is included in a class of drugs referred to as direct thrombin inhibitors which work by preventing the enzyme which causes blood cells to clot. This formulation of blood cells into clots can be dangerous since these clots travel throughout the body up to the brain leading to stroke or death.
The Food and Drug Administration approved Pradaxa for treatment of atrial fibrillation in October of 2010. Shortly after Pradaxa was approved, the health regulating agency received numerous reports claiming
Pradaxa causes internal bleeding.
Symptoms of internal bleeding often include unexpected bleeding or unusually long lasting bleeding, severe or uncontrollable bleeding, pink or brown urine, red or black stools, bruises with unknown cause, blood clots and coughing up blood, and many more.
Other reported side effects of Pradaxa include heart attack, gastrointestinal bleeding, brain hemorrhaging, internal bleeding, and death.
Pradaxa internal bleeding attorneys are currently in the process of investigating claims of adverse effects associated with Pradaxa. Though no recall has yet been issued the FDA is actively investigating reports of internal bleeding.
Category: Health News
Created: 2/14/2012 4:06:00 PM
Last Editorial Review: 2/15/2012
The Centers for Disease Control and Prevention is collaborating with public health officials in multiple states and the U.S. Food and Drug Administration (FDA to investigate a multistate outbreak of Shiga toxin-producing
Escherichia coli
serogroup O26 (STEC O26 infections likely linked with eating raw clover sprouts. Public health investigators are using DNA "fingerprints" of
E. coli
bacteria obtained through diagnostic testing with pulsed-field gel electrophoresis, or PFGE, to identify cases of illness that may be part of this outbreak. They are using data from
PulseNet, the national subtyping network made up of state and local public health laboratories and federal food regulatory laboratories that performs molecular surveillance of foodborne infections.
The full notice can be found at:
http://www.cdc.gov/ecoli/2012/O26-02-12/index.html
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