February 15, 2012
By Ethan A. Huff
“Isn’t Johnson & Johnson supposed to be one of the most trusted companies in the world? Apparently not.” –KTRN
For the first time, an individual user of the Johnson & Johnson (J&J) antipsychotic drug Risperdal is suing the pharmaceutical giant for allegedly committing fraud and lying about the safety of the drug. According to reports, Fletch Trammell, lawyer for the individual filing the suit, told a New Jersey jury that J&J knew as early as 1999 that Risperdal caused diabetes, but lied about it to the public in order to protect billions of dollars in sales.
Risperdal has been the subject of numerous lawsuits recently, including several filed by individual U.S. states that say they were defrauded by J&J’s illegal marketing of Risperdal, which includes marketing it for off-label purposes, and pushing doctors and health officials to promote the drug in place of less-expensive, safer alternatives.
But now an individual who says the drug caused him to rapidly gain weight and develop diabetes is making the same claims. Based on much of the same evidence used in the state lawsuits, Trammell says Janssen Pharmaceuticals, the division of J&J that manufactures Risperdal, engaged in an illegal coverup of data showing that Risperdal was more dangerous than one of its main competitors, Eli Lilly & Co.’s Zyprexa drug.
“He went to them for help and they gave him diabetes,” said Trammell of J&J concerning his client. This client, who reportedly did not have diabetes at the time and was not overweight, had begun taking Risperdal in 1996 after attempting to commit suicide. But not long after, the plaintiff reportedly gained a lot of weight very quickly, and by 2002 had developed full-blown diabetes.
October 25, 2011
By John Gever
“Keep taking your pharmaceuticals – they are good for you.” –KTRN
Eli Lilly is withdrawing drotrecogin alfa (Xigris) from all markets worldwide after a major study failed to show a survival benefit for patients taking the drug.
The company said it was “working with regulatory agencies on the withdrawal and is in the process of notifying healthcare professionals and clinical trial investigators.”
Xigris should be discontinued immediately in patients currently receiving it and should not be started in new patients, the company said.
The trial with the bad news on Xigris was called PROWESS-SHOCK, a placebo-controlled study with 28-day mortality as the primary outcome and planned enrollment of nearly 1,700 patients.
The study had been ordered by European regulators in 2008 as a condition of the product’s continued approval there. Data collection ended in September.
Specific outcomes were not reported, but Lilly said the primary endpoint of a statistically significant reduction in 28-day mortality had not been met.
“While there were no new safety findings, the study failed to demonstrate that Xigris improved patient survival and thus calls into question the benefit-risk profile of Xigris and its continued use,” said Timothy Garnett, MD, Lilly’s chief medical officer, in a press release.
“We believe the original Xigris approval [in 2001] was appropriate and these recent results were quite unexpected,” Garnett said. “A contributing factor to these study results could be advances in the standard of care for treating severe sepsis over the past 10 years.”
September 12th, 2011
By: S. D. Wells
Pharmaceutical firms in the United States are shelling out massive funds for doctors travel and entertainment expenses in hopes of boosting sales of new drugs. More than 160,000 doctors have received related payments in 2011 already.
The big push includes free samples, hospital detailing, journal ads, gifting, and the sponsoring of continuing medical education, but patients fear this all leads to doctors prescribing popular, money making drugs instead of following standard of care practices .
Pfizer, Eli Lilly, and AstraZeneca top the list of companies also spending far more on “marketing” than on research, with a total estimated $57,000 billion in overall marketing expenditures in just one year in the United States.
Pharmaceutical giants are claiming they are just trying to be open about how they conduct business, but the statements come at a time of intense scrutiny, and after several prosecutions regarding unlawful marketing practices.
In fact, some of these databases were actually set up as part of settlements of federal criminal investigations into the illegal marketing of drugs to doctors. Many companies have not released any data whatsoever, but Lilly and Pfizer combine to have paid out over 90 million dollars.
United States government agencies are preparing guidelines that will make such information mandatory by 2013. Currently there are over 80,000 pharmaceutical sales reps in the U.S. pursuing about 800,000 pharmaceutical prescribers, so it can be extremely difficult to track the money for one doctor from several sources, or to identify the largest recipients, like an entire hospital, without laborious work by a whole team of computer experts.
By 2013, new federal healthcare laws are expected to make it easier for the public to track a doctor’s payments from multiple companies; however, there may be controversial business opportunities available in the setting up and running of these supposedly transparent websites, such as PharmaShine, which was founded auspiciously by a former attorney for Merck.
Critics are complaining about the extreme conflicts of interest that arise from all the gift giving and promotional items, saying doctor’s can negatively influence the cost of medicine by recommending or prescribing brand name drugs over cheaper generics. In many instances, the reward is substantial for doctors to do exactly that. Over 380 doctors have earned more than $100,000 from drug companies in just the past two years.
But there is also a flip side to these perks. One doctor said he had to follow a slide show presentation word for word in order to receive funding for a speaking engagement promoting certain pharmaceuticals, or there would be changes made to his contract.
On top of all the other problems inherent in proper ethics and disclosure, many prominent doctors at academic medical centers have failed to disclose millions of dollars in drug company payments, and Federal prosecutors say some payments are really kickbacks for illegal or excessive prescribing. Are doctors now moonlighting as drug salesmen in order to keep the perks flowing?
August 22nd, 2011
By: Melly Alazraki
Does the market have you thinking about getting a little pharmacological help to ease your jitters and lift your mood? Getting a prescription for Prozac is easier than you think. In fact, you can skip the appointment with a psychiatrist altogether.
A study released last week in Health Affairs journal found a growing trend of doctors who aren’t psychiatrists offering antidepressants to patients. The meds often get prescribed without any psychiatric diagnosis, simply to boost someone’s mood, relieve mild anxiety, or improve sleep. Worse yet, there’s no evidence these drugs actually help such patients.
All these questionable prescriptions helped make this class of drugs one of the most commonly prescribed in the U.S. In 2010, according to IMS Health data, antidepressants spending grew to $11.6 billion. The class was the second most prescribed after cholesterol regulators and heart meds, with nearly 254 million prescriptions.
It’s No Secret Who’s Really Smiling
The growth in antidepressant use brings a smile to at least one group of people: Big Pharma.
While Eli Lilly’s (LLY) Prozac has long lost its patent protection, U.S. Cymbalta sales for 2010 grew 9% to $2.8 billion, topping the $758 million mark in the most recent second quarter. Bristol-Myers Squibb’s (BMY) Abilify U.S. sales grew by 5% in the recent quarter, to 517 million. AstraZeneca’s (AZN) second-quarter U.S. sales of Seroquel XR grew 14% to $205 million. (Both Seroquel XR and Abilify are atypical antipsychotics approved by the FDA as adjunct treatments for depression that doesn’t respond to a selective serotonin re-uptake inhibitor like Prozac or Zoloft alone.)
The study made no mention of any illegal marketing practices by pharmaceuticals that may have contributed to this trend, although such allegations regarding off-label marketing are certainly not foreign to AstraZeneca or Eli Lilly, among many others.
However, the study said that direct-to-consumer advertising could be causing patients to request the drugs. The U.S. and New Zealand are the only countries that allow advertising for prescription medications.
Do We Have a Drug Problem?
The researchers are concerned that this growing trend of non-psychiatrists prescribing antidepressants could mean that the drugs get prescribed inappropriately. They worry that patients who haven’t been properly diagnosed are not receiving the best care they need. The study suggests starting by educating physicians on mental disorders, the drugs, and their appropriate use.
The researchers also encourage patients to ask questions — lots of them, including questions about the diagnoses, the side effects, possible alternative treatments, and whether antidepressants are the right treatment for their problems in the first place.
November 17th, 2010
By: Catey Hill
1. This is illegal in Canada
An hour after munching on some light potato chips – made with fat substitute olestra — Debra Jaliman, 55, a Manhattan dermatologist, found herself so sick with abdominal cramps that she had to cancel her slate of patients. Reactions like these are why the Center for Science in the Public Interest, a consumer advocacy organization, says no one should eat olestra, and why Canada and the United Kingdom banned it. But it’s legal here – and you’ll find it in foods like low- or non-fat chips, crackers and cookies. Procter & Gamble, which sells olestra under the name Olean, says that nearly 6.5 million servings of foods containing Olean have been consumed since 1996, the year the FDA approved olestra for U.S. use.
Olestra isn’t the only banned substance that Americans are noshing on. Recombinant Bovine Growth Hormone, or rBGH (commonly sold under the name Posilac), a synthetic hormone injected into cows to stimulate milk production, pops up in many dairy-based snacks like ice cream. Not in the European Union or Canada, where it has been banned amid health concerns for both cows and humans, including fears that a hormone associated with cancer might be higher in people who drink milk treated with rBGH. (Eli Lilly, the company that manufacturers Posilac, denies these claims.) Meanwhile, rBGH is a lucrative product in the U.S.: A division of Eli Lilly bought Posilac for more than $300 million in 2008, and studies show Posilac can increase milk production in a cow by 15% or more, meaning more milk to sell.
2. We added pulverized insects to your snack
For Dr. James Baldwin, treating the 27-year-old woman for anaphylactic shock was easy, but figuring out what caused the reaction was a mystery. Several tests later, Baldwin discovered that the patient had a rare allergy to something she’d eaten—the carcasses of ground-up, boiled beetles, which are often used in snack foods to create those lovely shades of red, purple and pink in everything from fruit juice to ice cream to candy. “It’s a common colorant,” Baldwin says.
No, you won’t find the word “beetle” anywhere on food labels; instead, you’ll likely see the less cringe-worthy “carmine,” “carminic acid” or “cochineal extract.” And the beetle’s remains are big business. Peru, the largest exporter of cochineal in the world, produces about 2 million pounds of the dyestuff each year, according to Amy Butler Greenfeld, a Marshall Scholar at Oxford University and the author of “A Perfect Red,” which examines the history of cochineal. Experts say the industry in Peru grew about 15% per year during the past decade – and as the demand for natural color in foods grows, Greenfeld predicts that the cochineal industry will grow along with it.
3. Expiration date? There’s no expiration date
We’ve all chuckled over the urban legend that a Twinkie will stay fresh in its plastic wrap forever. Turns out, it’s not so far-fetched. The expiration date on highly-processed foods can be significantly longer than the date on the package, says Karen Duester, MS, RD, president of the Food Consulting Company, which advises companies on food labels and FDA regulations. In fact, if the product is well-sealed, kept away from light, and has a low fat and dairy content, it could last for years. That’s particularly true for canned snacks like maraschino cherries.
These “best by” dates are provided voluntarily by the manufacturer, but given that experts say these products are safe to eat after their expiration, why do they even bother? It encourages retailers to restock – and reorder – the product more often, says Duester. Plus, an expiration date pegged to 2015 isn’t exactly appealing to a customer.
October 25th, 2010
By: Gene Marical
Fighting depression, a highly prevalent and serious mood disorder that affects about 18.1 million adults in the U.S. is one of the largest markets in the pharmaceutical industry — and it’s still growing. More than 212 million antidepressant prescriptions were written last year, with 2009 antidepressant therapy sales totaling about $12 billion.
The major players in this market are the larger drugmakers, including Pfizer (PFE, through its recent purchase of Wyeth), Eli Lilly (LLY), Forest Laboratories (FRX), GlaxoSmithKline (GSK) and Merck (MRK, through its acquisition of Schering-Plough).
To this impressive list of Big Pharma companies, add the name of a tiny and little-known biotech, Clinical Data (CLDA). Why? The young company has developed a potential blockbuster antidepressant called Vilazodone, which analysts expect will be approved by the Food and Drug Administration for marketing early next year.
Because of Vilazodone, the buzz is Clinical Data has become an attractive takeover target for any one of the major players in the field. Vilazodone, if approved by the FDA, will be the first new entry into the antidepressant market in more than 15 years. Its importance is enhanced by the fact that several of the existing therapies are due to lose their patent protection before long. The three drugmakers likely to be interested — and said to have had some talks with several Clinical Data executives — are Eli Lily, Forest Labs and Pfizer.
No Impact on Sexual Function
What’s so special about Vilazodone when compared with the rest of the crowd? One major difference: Unlike its rivals, Vilazodone doesn’t suppress or affect a patient’s sexual function. That is a very important difference, indeed, according to industry analysts.
“Patients with depression usually experience difficulties with sexual functioning, which tends to be worsened by antidepressant treatments,” notes Chrystyna Bedrij, biotech analyst at Griffin Securities. Vilazodone, she says, is “neutral” on that particular issue, because it doesn’t harm a patient’s sexual ability. It neither enhances nor suppresses sexual functions, she explains.
Dr. Carol Reed, chief medical officer of Clinical Data, confirms that Vilazodone has a dual mechanism of action, which combines “selective serotonin reuptake inhibition” and “partial 5-HT receptor agonist” to reduce the impact on sexual function as measured by validated scales. Study findings corroborate, she says, that “there was no impairment of sexual function.”
The serotonin inhibitors, which enhance the availability of synaptic serotonin — a key brain chemical — are approved as safe and effective treatment for depression, says Reed. And the 5-HT receptor agonists have also been shown to be effective for treating mood disorders, including depression and anxiety, she adds.
Significantly Upbeat Results
Given the potential worth of Vilazodone’s lack of effect on sexual functioning, “it is positively differentiated from other antidepressants in the market,” says Griffin’s Bedrij. So, she rates Clinical Data’s stock a buy based alone on the appeal and potential value of Viladozone. She puts the intrinsic worth of Clinical Data, currently trading at $18 a share, at $33 a share.
Although no one can predict what the FDA will do, the betting is that Vilazodone, in all likelihood, will win approval because it has completed all the required clinical trials with significantly upbeat results on efficacy and safety, argues Bedrij. And Clinical Data’s new-drug application for Viladozone is supported by data from nearly 3,000 patients who “received the drug safely with a low occurrence of side effects,” notes the analyst.
All the other seven Wall Street analysts who track Clinical Data also rate the stock a buy, including those from Piper Jaffray, Roth Capital Partners and BMO capital Markets.
October 18th, 2010
By: David Gutierrez
Drug giant Pfizer has canceled a scheduled clinical trial of its antipsychotic drug Geodon after the FDA accused it of subjecting child participants in a prior study to “widespread overdosing.”
“After careful consideration, the company decided not to proceed with the study,” Pfizer spokesperson Gwendolyn Fisher said.
Fisher said that although the company had taken “preparatory steps” toward the trial, it had decided to abandon the study in order “to meet regulatory timelines.” No patients were enrolled.
Pfizer is seeking FDA approval to market Geodon for the treatment of bipolar disorder in children between the ages of 10 and 17. An FDA panel already rejected this use once in 2009 by a vote of 10-7, expressing concern that large numbers of participants had failed to complete clinical trials of the drug. The FDA asked Pfizer for further information on the drug’s safety in children, and the company responded by launching pediatric trials of the drug.
In April, the FDA warned the company that researchers in charge of the trials were engaging in “significant violations,” including “widespread overdosing” caused by inadequate company oversight.
Five months earlier, Pfizer had agreed to pay $2.3 billion to settle a collection of federal and state criminal and civil charges that it had improperly marketed Geodon and three other drugs.
Geodon, which made Pfizer $1 billion in 2009, is already approved for the treatment of bipolar disorder and schizophrenia in adults. Its competitors AstraZeneca and Eli Lilly have already secured FDA approval to use their respective antipsychotics Seroquel and Zyprexa to treat bipolar disorder in children.
Treatment of children with antipsychotics remains a controversial practice amid growing concern over major side effects such as severe metabolic changes and weight gain.
Although Geodon’s most recent safety trial has been canceled, the company made it clear that it still plans to secure FDA approval for pediatric use of the drug.
March 17, 2010
As much as $75 million in popular Eli Lilly & Co <LLY.N> prescription medicines such as Prozac were stolen during a raging storm from a Connecticut warehouse over the weekend, police said on Tuesday.
Burglars broke into the Lilly warehouse either late Saturday or early Sunday in the town of Enfield, Connecticut, as violent rain and winds lashed the Eastern seaboard, Enfield Lt. Steven Kaselouskas said.
“You certainly don’t see a $50 million to $75 million burglary many times in your career,” he said. “This was a well-planned event.”
The thieves disabled a burglar alarm in the building and carted away dozens of pallets loaded with Lilly antidepressants Prozac and Cymbalta, anti-psychotic Zyprexa and other company medicines, according to published reports.
A warehouse employee saw the hole in the roof on Sunday afternoon and notified police. Police did not receive notice of an alarm going off, said Kaselouskas.
Kaselouskas speculated the drugs could be headed for the black market and possibly overseas, where there is demand for medicines made in the United States because of their deemed safety.
Lilly officials could not immediately be reached for comment and did not issue a release about the theft.
But a Lilly spokesman said in a published report the loss may not have a material financial impact for the company and has not disrupted supply of medicines to the east coast.
January 13, 2010
By Associated Press
The Food and Drug Administration has issued enforcement letters to four drug makers for making inaccurate or incomplete statements in drug promotions.
The letter to Eli Lilly cites an ad for the antidepressant Cymbalta. According to the FDA, the ad did not adequately display information about side effects. The company said it is working to remove the materials from marketing circulation.
Cephalon faces similar complaints about missing risk information in promotional cards for Treanda, a lymphoma treatment. A spokeswoman said the company has instructed sales people to stop using the card.
Regulators took issue with statements made by Amylin Pharmaceuticals about its diabetes drug Byetta.
Amylin and partner Lilly said they “will take action as needed.’’
Also, the FDA said Bayer’s script for a presentation on its birth control implant Mirena “overstates the efficacy.’’
The company has ended the promotion.
August 3, 2009
By Maggie Fox
Use of antidepressant drugs in the United States doubled between 1996 and 2005, probably because of a mix of factors, researchers reported on Monday.
About 6 percent of people were prescribed an antidepressant in 1996 — 13 million people. This rose to more than 10 percent or 27 million people by 2005, the researchers found.
“Significant increases in antidepressant use were evident across all sociodemographic groups examined, except African Americans,” Dr. Mark Olfson of Columbia University in New York and Steven Marcus of the University of Pennsylvania in Philadelphia wrote in the Archives of General Psychiatry.
“Not only are more U.S. residents being treated with antidepressants, but also those who are being treated are receiving more antidepressant prescriptions,” they added.
More than 164 million prescriptions were written in 2008 for antidepressants, totaling $9.6 billion in U.S. sales, according to IMS Health.
Drugs that affect the brain chemical serotonin like GlaxoSmithKline’s <GSK.L> Paxil, known generically as paroxetine, and Eli Lilly and Co’s <LLY.N> Prozac, known generically as fluoxetine, are the most commonly prescribed class of antidepressant. But the study found the effect in all classes of the drugs.
Olfson and Marcus looked at the Medical Expenditure Panel Surveys done by the U.S. Agency for Healthcare Research and Quality, involving more than 50,000 people in 1996 and 2005.
“During this period, individuals treated with antidepressants became more likely to also receive treatment with antipsychotic medications and less likely to undergo psychotherapy,” they wrote.