Showing posts with label drug companies. Show all posts
Showing posts with label drug 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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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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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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Saturday, December 18, 2010

How an antidepressant can hurt your patient, KevinMD.com

Patients still have shame about seeking help from a psychiatrist or other mental health professional. So they ask help for their depression from their primary care physician. The PCP feels an emotional pressure to provide the quick fix in that 15-minute appointment – the same pressure that he responds to when prescribing antibiotics to a adequately squeaky wheel of a patient with a common cold.

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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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Wednesday, November 17, 2010

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