Showing posts with label pharmaceutical companies. Show all posts
Showing posts with label pharmaceutical companies. Show all posts

Thursday, May 5, 2011

Clinical Trial Deaths And Compensation In India // Pharmalot

An investigation by India’s health ministry has found that drugmakers running clinical trials in the country have not compensated survivors of most volunteers who died during their studies. Of 671 deaths that were reported last year, there is evidence that compensation was given in just three cases, The Business Standard writes.

And so, the health ministry has asked 44 drugmakers to explain why they have not provided compensation, which is mandatory under the current law. Among those queried were Eli Lilly, Novartis, Pfizer, Bayer, Merck, Johnson & Johnson and Sanofi-Aventis. For instance, data compiled by the ministry show there were 152 deaths reported during Sanofi trials and 138 took place in Bayer trials.

A Novartis spokesperson tells the paper that its clinical trial investigator insisted any deaths were not caused by a medication, but instead due to the progression of underlying diseases. And compensation is not required in such cases. Other drugmakers offered a similar argument. Ministry officials also say that most deaths, which were attributed to cancer or cardiovascular and cerebrovascular disorders, seemed to have occurred due to the advanced stage of illness among volunteers.

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Tuesday, April 26, 2011

How academic physicians turn into drug company shills, KevinMD.com

by Carl Elliott

These days many thought leaders find themselves on shaky ground. The past few years have not been good for business. Some of the most prominent thought leaders have been exposed and censured by Grassley. Others have seen public opinion turning against them and gone underground. As more states institute Sunshine laws, anyone considering an industry consultancy must weigh the money and status boost against the potential downside of public exposure.

Still, the thought-leader business has proved more resilient than many people predicted. Most of the thought leaders investigated by Grassley have managed to retain their academic positions, even in the face of withering criticism. A resistance movement has even formed. Led by Dr. Thomas Stossel of Harvard University, the Association of Clinical Researchers and Educators (ACRE) has defiantly opposed attempts to cut back industry payments to doctors.

Many former thought leaders simply confess disillusionment. “There is a feeling that you want to be where the action is, and even if it’s not real action, at least industry gives you the feeling that things are happening,” Healy says. “They give you the feeling that you’re up on the wave.” After a while, however, the thrill of consulting begins to wear thin. There are just too many airports, too many hotels, too many fancy dinners. Eventually they all look the same. Healy says, “You’ve got a choice between the boredoms of perpetually surfing—where the first two waves are fun, but eight hours later, Jesus Christ—or do you return to the tedium of the beach?”

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Saturday, April 16, 2011

Big Pharma backs deal to boost flu pandemic readiness | Reuters

Virus samples will be shared globally in exchange for vaccines produced from them under a landmark deal to improve preparedness for a flu pandemic, diplomats at the World Health Organization said on Saturday.

In a statement to Reuters, the International Federation of Pharmaceutical Manufacturers and Associations, which represents 26 research-based drugmakers, welcomed the plan and confirmed the commitments its members had undertaken as part of it.

Negotiators ended an all-night session with a draft agreement accepted by all countries, including the United States, the last to join the consensus, diplomats said.

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Thursday, March 31, 2011

Conflicts Of Interest In Guideline Development: A Dirty Little Secret Gets Aired Again | The Health Care Blog

An Archives of Internal Medicine article (Conflicts of Interest in Cardiovascular Clinical Practice Guidelines) is getting a lot of notice today. In essence, many of the physicians who develop guideline that influence practice patterns and payment decisions have conflicts. The authors recommend only allowing those without conflicts to write the guidelines.

This isn’t a new issue. In 2006 I wrote a piece (Another dirty little secret is out in the open) and am reposting it below because it’s timely:

A year ago in Time to deal with medicine’s dirty little secrets?, I wrote about a variety of practices that are relatively well-known in the health care field but would be shocking to outsiders. Industry often takes the blame for “aggressive marketing tactics,” and no doubt some of that is deserved. But physicians are also culpable.

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Andrew Lopez, RN
Nursefriendly, Inc. A New Jersey Corporation.
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856-415-9617, (fax) 415-9618

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Tuesday, March 29, 2011

Drug Shortages Distress Hospitals - WSJ.com

A shortage of injectable generic drugs for cancer and other serious diseases is putting pressure on hospitals, which are sometimes having to scramble to locate the medicines or search for alternative treatments.

The supply of these drugs has tightened in recent years as the generic-drug industry has consolidated, with many of the drugs now made by just one or two companies. In many cases patents have long expired and the original brand-name drug is no longer being produced.

Federal regulators have also stepped up enforcement of quality standards, limiting the ability of large manufacturers to ramp up production.

The drugs—typically used in hospitals and outpatient clinics—often require complex manufacturing processes with long lead times. Because factories produce many kinds of medicines, companies say they can't easily make more of one without creating a shortage in another.

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Andrew Lopez, RN
Nursefriendly, Inc. A New Jersey Corporation.
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Thursday, March 24, 2011

Branded drug prices soar as generic pressure rises | Reuters

Pharmacists in Jordan-based Hikma Pharmaceuticals package generic versions of Ciprofloxacin hydrochloride 750 mg which will be exported to the U.S. and Western markets in Amman February 8, 2011. REUTERS/Ali Jarekji

LOS ANGELES | Wed Mar 23, 2011 11:46am EDT

LOS ANGELES

(Reuters) - U.S. prices for brand-name drugs are rising faster than ever as patents expire on top-selling medicines and the pharmaceutical industry nervously eyes the future of healthcare reform.

Prices for the 15 best-selling drugs rose by much higher rates in 2010 than they did in each of the last five years, according to exclusive data from Thomson Reuters MarketScan, which measured the average cost of a daily dose as shown in medical claims data.

Two thirds of the drugs saw double-digit price hikes, well above inflation of 1.6 percent in 2010 measured by the consumer price index. The analysis indicates drug makers are scrambling to make as much money as possible from blockbuster drugs before their patents expire, while taking advantage of the fact that last year's healthcare reform bill did not cap drug prices.

According to MarketScan, payments for Pfizer Inc's Lipitor rose 11.4 percent last year, compared with 5 percent annually from 2005 to 2010. That meant the cost of a daily dose of the cholesterol drug rose from $3.17 at the end of 2009 to $3.53 at the end of 2010. Lipitor, which will soon lose patent protection, had 2010 global sales of $10.7 billion.

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Andrew Lopez, RN
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Friday, March 11, 2011

FDA takes over Johnson & Johnson's Tylenol plants - Mar. 10, 2011

The government is taking over three Tylenol plants following a blizzard of drug recalls and a Food and Drug Administration criminal investigation into safety issues at the factories.

The FDA and the Justice Department on Thursday took action against McNeil PPC and two of its executives -- its vice president of quality and its vice president of operations for over-the-counter products -- for failing to comply with federally-mandated manufacturing practice.

McNeil, a division of Johnson & Johnson (JNJ, Fortune 500), said it had agreed to put its plants -- one in Las Piedras, Puerto Rico, one in Fort Washington, Pa. and one in Lancaster, Pa., under FDA supervision.

The agreement, known as a "consent decree," is subject to approval by a federal judge in Pennsylvania.

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Andrew Lopez, RN
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Wednesday, February 23, 2011

Drug maker cited for not reporting side effects - Health - Health care - msnbc.com

U.S. health regulators have warned Sanofi-Aventis SA's U.S. unit for failing to submit reports of possible serious side effects in a timely manner.

In a January 28 letter made public on Tuesday, the Food and Drug Administration said an early response from the drugmaker and its "promised corrective actions are inadequate to address the deficiencies."

"We remain concerned that your .... adverse drug experience reporting system has not been fully validated, and may have resulted in inaccurate assessment and untimely submission of 15-day alerts," FDA said.

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Medical News: Supreme Court Sides With Vaccine Maker - in Washington-Watch, Washington Watch from MedPage Today

The Supreme Court has ruled 6-3 that a federal law shields drug companies from being sued over injuries caused by childhood vaccines.

The case was brought by the parents of Hannah Bruesewitz, now a young adult, and charges that she developed a seizure disorder after receiving her third dose of the diphtheria-tetanus-pertussis (DTP) vaccine when she was 6 months old. She has suffered developmental problems ever since, and will likely require medical attention for the rest of her life, her parents say.

The dose of the vaccine in question, TRI-IMMUNOL, came from a lot that generated 65 reports of adverse reactions, including 39 emergency room visits, six hospitalizations, and two deaths, according to documents from the U.S. appeals court that heard the case in 2009.

The National Childhood Vaccine Injury Act of 1986 created a so-called "vaccine court" to address safety claims in an attempt to ease the threat of lawsuits in state courts against pharmaceutical companies and insure against them pulling out of what they claim is an unprofitable vaccine marketplace completely.

Under the law, people injured by vaccines are eligible for compensation for medical care, rehabilitation, counseling, special education, and vocational training expenses; diminished earning capacity; pain and suffering; and $250,000 for vaccine-related deaths.

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Tuesday, February 15, 2011

Obama budget targets brand name medicines, Health.Yahoo.net

Big pharmaceutical companies could face increased competition from generic drugmakers under two proposals put forth by the Obama administration on Monday despite earlier savings extracted from drugmakers as part of last year's healthcare law.

President Barack Obama, as part of his 2012 budget proposal, called for cutting the number of years drugmakers could exclusively market brand-name biologic drugs to 7 years from 12.

He also set his sights on ending controversial "pay-for-delay" deals that affect traditional, chemical drugs by giving the U.S. Federal Trade Commission power to block them. Under such pacts, brand-name and generic drugmakers settle patent challenges with payoffs that delay lower-cost rivals from reaching the market.

The proposals face a tough challenge of getting through the divided Congress, but could alter the landscape for consumers' access to cheaper medicines.

They quickly drew industry protests.

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Andrew Lopez, RN
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Saturday, January 15, 2011

Oregon sues Johnson & Johnson over "phantom" Motrin - Jan. 13, 2011

Oregon has sued Johnson & Johnson for allegedly selling defective Motrin drugs to consumers in the state for more than a year, and for trying to secretly remove the faulty drugs from stores.

"Companies that break the rules and put consumers at risk will be held accountable," Oregon Attorney General John Kroger said in a statement.

The state filed the lawsuit Wednesday against J&J (JNJ, Fortune 500) and its two subsidiaries, McNeil PPC Inc. and McNeil Healthcare Inc. The company's McNeil division makes over-the-counter cold and pain drugs such as Tylenol, Motrin and Benadryl.

The suit claims that J&J discovered in late 2008 that some supplies of Motrin sold in gas stations and convenience stores nationwide were defective because they were not properly dissolving.

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Monday, January 3, 2011

New Drug Approvals Slipped in 2010 - WSJ.com

The Food and Drug Administration approved about 21 drugs in 2010, a relatively modest figure that shows the pharmaceutical industry hasn't yet escaped its drought in recent years.

A few potential blockbusters won approval during the year, but some of the most highly anticipated new products got delayed into next year or beyond. That partly reflects a tougher environment at the FDA, with regulators stepping up their scrutiny of safety issues in drugs for obesity, diabetes and other conditions.

According to monthly drug-approval reports on the FDA's website, 21 new drugs were approved in 2010, down from 25 in 2009 and 24 in 2008, but higher from a recent low of 18 in 2007.

The final approval figures, as well as the number of applications received by the agency in 2010, won't be available until next month. The approval figures don't include dozens of approvals granted for new formulations or new uses of existing drugs.

Although the 2010 figures are a bit lower than previous years, FDA spokeswoman Sandy Walsh said there's "no systemic change in how the FDA is approaching drug approvals."

The figures include several major biologic drugs, which are created from living cells and represent a growing portion of the pharmaceutical market. Amgen Inc. won approval for Prolia, a drug that is injected twice yearly to treat osteoporosis in postmenopausal women. Roche Holding AG's biotechnology unit, Genentech, won approval for Actemra, a drug that's administered intravenously to treat rheumatoid arthritis.

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Andrew Lopez, RN
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Sunday, January 2, 2011

Drug recalls surge to more than 1,700 in 2009 - Aug. 16, 2010

Recalls of prescription and over the counter drugs are surging, raising questions about the quality of drug manufacturing in the United States.

The Food and Drug Administration reported more than 1,742 recalls last year, skyrocketing from 426 in 2008, according to the Gold Sheet, a trade publication on drug quality that analyzes FDA data.

One company, drug repackager Advantage Dose, accounted for more than 1,000 of those recalls. Even excluding Advantage Dose, which has shut down, recalls jumped 50% last year.

"We've seen a trend where the last four years are among the top five for the most number of drug recalls since we began tallying recalls in 1988," said Bowman Cox, managing editor of the Gold Sheet. "That's a meaningful development."

The fast pace of drug recalls seems to be continuing in 2010. Drug recalls totaled 296 from January through June of this year, said Cox. "If we continue at this same rate, we could get 600 or more recalls by the end of the year," he said. "That's still a very high rate of recalls."

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Andrew Lopez, RN
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856-415-9617, (fax) 415-9618

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Thursday, November 18, 2010

Still on payroll despite fatal mistakes - Health News Florida

Of all the doctors in Florida that GlaxoSmithKline could have chosen as consultants, Steven Brooks and his partner E. “Jake” Jacobo would seem the least likely. They have a criminal record.

In 2001, the Orlando-area urologists pleaded guilty in U.S. District Court in Connecticut to one count of conspiracy to defraud Medicare and the military through a complicated black-market diversion of the pricey prostate cancer drug Lupron.

Despite the blotch on his record, Brooks is Florida’s third-biggest recipient of pharma speaking fees overall and commands by far the largest fees among those who have been disciplined, according to a data-mining  project by the investigative news site ProPublica. Working with the team there, Health News Florida analyzed the data for Florida and wrote a state-based analysis. 

Over the last 18 months, GlaskoSmithKline paid Brooks over $178,000, ProPublica found. The company also paid Jacobo $14,750.

Brooks

In the criminal case, federal prosecutors allowed the doctors to plead to a misdemeanor in return for repaying the government $1.1 million. They were sentenced to five years’ probation and 500 hours of community service.

According to an account in the Orlando Sentinel at the time, the doctors' attorney portrayed them as duples of pharmaceutical sales reps. He said it seemed like a business deal: The doctors bought extra supplies of Lupron in states where it was less expensive and arranged for resale in states where costs were higher, records said. This violated wholesale drug distribution laws.

The Florida Board of Medicine fined each doctor $10,000 and required them to take classes in medical ethics and risk management. Brooks gave up his medical license in New York, rather than fight charges stemming from the case.

Neither Brooks nor Jacobo returned calls from Health News Florida. A call to the drug company seeking information on the urologists’ roles as consultants and on whether the company knew about the federal case also went unanswered.

Who's running trials on new drugs?

Pharmaceutical companies depend on physicians to run clean clinical trials so they can get the data they need for Food and Drug Administration approval. Yet two drug-company consultants in Florida received FDA warning letters the over the way they ran clinical trials.

Last year, the FDA cited Francisco Hernandez of Hialeah for enrolling the wrong patients in a clinical trial of a diabetes injectable drug made by Sanofi-Aventis. Of 15 patients Hernandez enrolled, the letter said, 12 didn’t qualify.

The FDA also said Hernandez didn’t report illnesses in two of the patients that were serious enough to require hospitalization.

A similar letter went to Jeffrey R. Levenson in St. Petersburg for his work on the investigational drug Zyvox for Pharmacia and Upjohn in 2000, records show.

Levenson enrolled some subjects who were too sick to meet the outlines for the trial or even to give informed consent, the letter said. He also failed to report serious adverse events, it said.

Hernandez received $6,000 in the past year and a half from Lilly for consulting, records show. Levenson received $2,000 from GlaxoSmithKline and about $1,800 from Pfizer.

Neither returned calls from Health News Florida.

Experts on prescribing? Not so much

Doctors who are  paid speakers for drug companies are supposed to be experts in prescribing. According to records, though, several in Florida were anything but -- including psychiatrist Joseph John Altieri of Vero Beach.

(He is not to be confused with Dr. John Joseph Altieri, a Sarasota-based cardiologist)

Psychiatrist Altieri came before the Board of Medicine in 2008, charged with inappropriate prescribing to three patients.

In case documents, Department of Health investigators said Altieri provided a “constantly changing cocktail” of addictive drugs -- including potentially lethal narcotics such as oxycodone and morphine – to patients who Altieri knew or should have known were addicts.

The Board of Medicine found Altieri violated a slew of codes on physician conduct. He was fined $30,000 and placed on two years’ probation, with another physician supervising.

The DOH web site says Altieri recently completed his probation, but while it was still in force last year, he received $1,040 in speaking fees from Pfizer.

He did not return calls from Health News Florida.


Still on payroll, despite fatal mistake

Some doctors remain as speakers for drug companies, even after making very public, fatal mistakes.

Case in point: Tampa urologists Tod Fusia and Mark Swierzewski remain in demand as drug-company speakers even though they made a slip-up in surgery, killing a popular high-school teacher in October 2002,

The aim of the operation at St. Joseph’s Hospital was removal of a cancerous kidney. With Swierzewski assisting, Fusia used the then-new robotic arm to snip what he thought were the proper blood vessels. But they turned out to be the aorta and vena cava.

Despite efforts to stitch the vessels back together, the patient died the next day.

Their insurer settled the malpractice case for $1 million. The Florida Board of Medicine and Fusia settled the administrative charges with a $10,000 fine and 100 hours of community service.

Still, during the past 18 months, Fusia has received $6,500 in speaking fees from GlaxoSmithKline, according to ProPublica. Swierzewski got $4,175 from Lilly.

Neither of them returned calls from Health News Florida.

Not fatal, but still...

Another who bounced back from public humiliation is Dr. Charles C. Greene, an ear-nose-throat specialist in Jacksonville. In March 2002, when he set out to repair a patient’s blocked nasal passages by inserting tubes and instruments, he went too far.

An instrument penetrated the brain and removed part of the frontal lobe, according to Department of Health records. When the patient developed symptoms, Greene failed to act swiftly enough, the records said.

Other doctors eventually diagnosed a leak of brain fluid, blood clots in the brain and brain damage.

The family sued Greene and the parties reached a $500,000 settlement in April 2004. Greene also paid a $326,700 settlement in 2004 in a separate case.

In 2009 and 2010, GlaskoSmithKline paid Greene $16,600 in speaking fees, ProPublica found.

He did not return calls from Health News Florida.

--David Gulliver is an independent  journalist and founder of Sarasota Health News. Carol Gentry, Editor of Health News Florida, can be reached by e-mail or at 727-410-3266. 

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