Weak Aftermarket Review Effort at FDA

A recent New York Times article that draws attention to the fact that up until 2002, it was a common practice for the pharmaceutical industry to ply physicians with free dinners, tickets or other high priced swag-- and that FDA Officers allegedly have proof that this practice has not stopped, but continues unabated.

That's really bad, but hardly unexpected. Expect corporations to behave poorly. It's not like the government was working in conjunction with drug companies to approve unsafe drugs.

Ahem.

There is a much more interesting factoid further down in the article. It seems the FDA has 1000 staff members working to approve new drugs but only around 100 working on making sure existing drugs are safe.

Dr. Bruce Psaty, a professor of medicine and epidemiology at the University of Washington, told the panel that the agency had become too focused on approving new drugs at the expense of making sure that approved ones were safe. This could make the upcoming Vioxx class action much more interesting.

"In the office of new drugs, more than 1,000 employees work to review a few dozen new drugs per year," Dr. Psaty said. "In the office of drug safety, 109 employees work to evaluate the safety of thousands of drugs currently on the market."

He described the agency's structure as "just what the drug industry desires: a powerful engine to approve new drugs and a weak effort to investigate safety in a postmarketing center."

[Read More]

FDA official says agency acted too slowly on Vioxx

After the Food and Drug Administration insisted for months that it had done nothing wrong in its oversight of the withdrawn pain pill Vioxx, a top agency official acknowledged "lapses" in the agency's actions before a Senate panel Tuesday.

Kweder said the agency had taken too long to get information about Vioxx's heart risks into the prescribing label that is provided to physicians. More than a year passed between an advisory panel's conclusion that those risks should be highlighted and the actual label changes, she said.

Kweder blamed the delay on difficult negotiations with Vioxx's maker, Merck. "We don't have the authority to tell a company, 'This is how your label has to look,' " she said. "We have to negotiate with the company the specific language of how things should be worded."

[Read More]

Folksonomies

fda vioxx senate washington kweder health education stroke graham stavropoulos celebrex bextra pfizer merck heart grassley tysabri sclerosis biogen idec elan

Drug Companies To Dependent on Niche Drug Profit

The Bangor Daily News makes an interesting point. Dr. Erik Steele's opinion is that drug companies pin their hopes to a 'blockbuster' drug and in their one-mindedness to get the drug out the door and the profits rolling in, they may choose to overlook a few 'setbacks the drugs may have during clinical trials.

"...pharmaceutical companies are progressively dependent for their profits on the manufacture and sales of hot drugs such as Vioxx ($2.5 billion in annual sales for Merck) and similar drugs Celebrex and Bextra (combined $4.8 billion in annual sales for Pfizer). The companies are under tremendous pressure, primarily from stockholders, to make big profits, they have fewer drugs likely to make big profits in their research and development pipelines than in the past, and drugs such as Vioxx are corporate lifesavers. Vioxx sales alone accounted for 20 percent of Merck Pharmaceutical's profits in 2003.

This reliance on a few blockbuster drugs means patient safety jockeys with corporate profits as the manufacturers' first priority in decisions about drug marketing. If Merck had highlighted a significant safety issue with Vioxx early on, the drug would have lost the main reason for its success over rivals, that being its lower risk of stomach bleeding as a side effect. Its side effects and its withdrawal from the market in September 2004 will cost Merck an estimated $14 billion in lawsuits and lost sales, and the company lost $28 billion in stock value when investors heard the bad news about Vioxx, according to a recent article in the New England Journal of Medicine (NEJM). Safety problems with a drug such as Vioxx can shake a drug company to its financial core."

[Read More]

Folksonomies

prescription drug pharmaceutical marketing Vioxx blockbuster disaster Merck Celebrex Bextra Pfizer NEJM financial Bayer Cervistatin FDA Steele Bangor Maine

For The Drugs I Need...

Consumers Union, the advocacy group behind Consumer Reports Magazine, has produced an animation that calls attention to the fact that current FDA rules don't require drug companies to release their clinical trial results even if they show that the pill you're about to take could have dire consequences.

The animated short is a tool to help promote the Fair Access to Clinical Trials Act (FACT Act)that will compel drug companies to release their clinical trial results to the public and create an independent office of drug safety in the Food and Drug Administration to ensure quick action is taken when safety concerns are raised.

First we learn that Vioxx increases the risk of heart attacks. Now, we learn that Merck may have had research, as early as 2000, that uncovered these problems, but didn’t make it known to the public. It is time to end this secrecy. Lives depend on it.

[Read More]

Beyond Vioxx

As painkiller scrutiny continues, some patients are turning to drug-free alternatives.

In the wake of a highly publicized investigation into the safety of Cox-2 inhibitors, the class of painkillers that Vioxx belongs to, it appears more patients with arthritis and other forms of chronic pain are turning a curious eye to drug-free remedies, such as acupuncture, chiropractic, dietary supplements and exercise. Backed by a growing body of research, more doctors are too.

"Some people really need to take medication and I certainly don't want them to feel bad about that," stressed Andrea Montoya, a certified physician assistant with Boulder Valley Rheumatology in Longmont. "But I think in general, people have thought more about 'what else can I do in addition to taking medication for my pain.' I think that it's great. I definitely encourage it."

[Read More]

Folksonomies

scandal Vioxx legal government legislation liability medical trial

Merck Issues Statement on Granting of Coordinated Pre-Trial Status For Federal Vioxx Lawsuits

The federal Judicial Panel on Multidistrict Litigation granted motions by several parties, including Merck, to transfer all Vioxx shareholder suits pending in federal courts nationwide into one consolidated Multidistrict Litigation (MDL) for coordinated pre-trial proceedings.

[Read More]

Folksonomies

scandal Vioxx legal government legislation liability medical trial

Vioxx makers 'perplexed' by Dosanjh's remarks

The makers of the popular painkiller Vioxx say they are "perplexed" by harsh allegations from the federal Health Minister that they have withheld safety data from the Canadian government.

In a statement, Ms. Gauthier added: "The Company responded in writing to Health Canada's request for information and has offered to meet with Health Canada officials at their convenience. We had not received any verbal or written feedback to our letter until we saw the Minister's comments in the newspaper."

Mr. Dosanjh had told The Globe that he is considering boosting Health Canada's legal authority to force a drug company to turn over information the department requests.

[Read More]

Folksonomies

scandal Vioxx legal government legislation liability Canada Dosanjh

Was Painkiller FDA Panel Stacked?

Almost a third of the members of a government panel that voted last week to let the pain pills Celebrex, Bextra and Vioxx stay on the market recently consulted for the makers of the drugs. Without the votes of those 10 members, the committee would have voted 12 to 8 for Bextra's withdrawal and 14 to 8 against Vioxx.

According to the report, disclosures in medical journals and other public records show that ten of the 32 panel members have done some work for Merck, the maker of Vioxx; Pfizer, the maker of Celebrex and Bextra; or Novartis, which is applying to sell Prexige, a similar type of medication.

Without the votes of those 10 members, the committee would have voted 12 to 8 that Bextra should be withdrawn and 14 to 8 that Vioxx should not return to the market. The 10 advisers with company ties voted 9 to 1 to keep Bextra on the market and 9 to 1 for Vioxx's return.

Folksonomies

scandal Vote Vioxx legal government legislation liability FDA