Drugs & Medicaments

Further Evidence of CV Harm With Rosiglitazone

2007-12-20T17:57:21Z

More evidence supporting the idea that rosiglitazone (Avandia, GlaxoSmithKline) does increase the risk of cardiovascular events has come from a new population-based study [1].

The retrospective case-control study, published in the December 12, 2007 issue of the Journal of the American Medical Association, was conducted in older patients with diabetes and showed that thiazolidinedione (TZD) treatment, primarily with rosiglitazone, was associated with an increased risk of congestive heart failure (CHF), myocardial infarction (MI), and mortality when compared with other combination oral hypoglycemic agent treatments.

The study has reignited the arguments surrounding the safety of rosiglitazone, with Dr Steven Nissen (Cleveland Clinic) issuing new calls for more forceful action on the drug from the Food and Drug Administration (FDA), while GlaxoSmithKline highlights limitations of the new study and continues to defend the cardiovascular profile of its product.

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Further Evidence of CV Harm With Rosiglitazone CME

News Author: Sue Hughes
CME Author: Hien T. Nghiem, MD
Disclosures

Release Date: December 13, 2007; Valid for credit through December 13, 2008

Credits Available

Physicians - maximum of 0.25 AMA PRA Category 1 Credit(s)™ for physicians;
Family Physicians - up to 0.25 AAFP Prescribed credit(s) for physicians

from Heartwire — a professional news service of WebMD

December 13, 2007 — More evidence supporting the idea that rosiglitazone (Avandia, GlaxoSmithKline) does increase the risk of cardiovascular events has come from a new population-based study [1].

In the paper, the authors, led by Dr Lorraine Lipscombe (Institute for Clinical Evaluative Sciences [ICES], Toronto, ON), note that most studies to date have examined adverse cardiovascular outcomes associated with TZDs among clinical-trial samples, but the extent to which these adverse effects apply to real-world populations is less clear. In addition, the majority of clinical trials were limited to patients younger than 65 years, even though those aged 65 years or older have the highest prevalence of diabetes and represent more than 40% of the population with diabetes.

They therefore investigated the risk of heart failure, MI, or death in diabetic patients over the age of 65 taking a TZD compared with those taking other oral hypoglycemic agents in a nested case-control analysis of a retrospective cohort study using healthcare databases in Ontario. The study population consisted of 159,026 diabetes patients (mean age 74.7 years) being treated with an oral hypoglycemic agent. During the median 3.8-year follow-up, 7.9% of the patients had a hospital visit for CHF, 7.9% had a visit for MI, and 19% died. The risks of these events were compared between persons treated with TZDs (rosiglitazone and pioglitazone [Actos, Takeda Pharmaceuticals]) and other oral hypoglycemic agent combinations, after matching and adjustment for prognostic factors.

Results showed that treatment with TZD monotherapy was associated with a significantly increased risk of congestive heart failure, MI, and death and that this increased risk appeared limited to rosiglitazone.

Adjusted relative risk of CHF, MI or death with TZDs vs other oral hypoglycemic agents

Outcome	Relative Risk With TZDs	95% CI
CHF	1.60	1.21 - 2.10
MI	1.40	1.05 - 1.86
Death	1.29	1.02 - 1.62

Lipscombe et al report that treatment with TZDs was also associated with a higher risk of CHF and death regardless of whether it was used as monotherapy or in combination with other oral agents, which they say further enhances the argument for a causal relationship with these outcomes.

They write: "Our findings argue against the current labeling of TZDs, which warns against use only in persons at high risk of CHF, as we did not identify any subgroup of older diabetes patients who may be protected from the adverse effects of TZDs." They add: "Our results suggest that the numbers needed to harm over four years were approximately 26 for acute myocardial infarction (AMI), 34 for CHF, and 22 for death. The magnitude of harm observed in our study may therefore be sufficient to outweigh any potential benefits associated with TZDs in an older, higher-risk population."

Noting that the US FDA has recently decided that the available data are thus far inconclusive to warrant withdrawing rosiglitazone from the market, they say that this "well-designed population-based study provides more convincing evidence that rosiglitazone is associated with an increased risk of cardiac events and deaths among elderly patients with diabetes."

Nissen: Further action now required

Commenting on the study for heartwire, Nissen said, "These are pretty striking data. It has the weakness of being an observational study, which is not the same as randomized data, but it has the advantages of being very large, with 159,000 patients, and it is not sponsored. The results are quite remarkable in that they show a very similar increase in risk of MI as we did in our meta-analysis. And the numbers needed to harm one patient are very low in this study. It suggests that for every 22 patients treated with rosiglitazone, one will die. I don't remember seeing numbers that low before in terms of benefit or harm. Even if these data are retrospective, it must be considered within the context of what we already know. And we have already had four meta-analyses, all of which have shown increased cardiovascular risk with rosiglitazone. These new data agree completely with what is already out there and have shown again that everything is going in the wrong direction with this drug. These data really increase the pressure on the FDA to take further action on rosiglitazone. The FDA's recent warning was very weak, and now there is even more evidence to support more forceful action."

GlaxoSmithKline response

GlaxoSmithKline issued a statement on the ICES study, saying it believes the retrospective analysis has significant limitations and generates misleading conclusions regarding MI and death. It states: "These conclusions are inconsistent with a more robust body of evidence from large, long-term, prospective, well-designed clinical studies, including A Diabetes Outcome Progression Trial (ADOPT) and the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD). These long-term trials in diabetic patients comparing rosiglitazone with other oral antidiabetic medicines show no increased risk for cardiovascular events compared with other commonly used medications, other than the well-known risk of congestive heart failure with thiazolidinediones."

The company adds that the current study is also inconsistent with the findings of large epidemiological studies presented during the recent FDA advisory committee meeting, the majority of which show that rosiglitazone is not associated with an increased risk of MI compared with other antidiabetic agents.

GlaxoSmithKline suggests that the inconsistency could be due to the fact that the rosiglitazone patients were older and sicker and had more chronic diseases — and therefore higher baseline risk for cardiovascular (CV) events — than patients in other medicine groups. "The problems with the study become obvious with regard to the findings for congestive heart failure — we know members in this drug class (TZDs) have well-documented and similar CHF events, yet this study somehow finds an increase in these events with Avandia vs Actos, a finding that is inconsistent with known science," it says.

The company further notes that the ICES analysis does not correct for the fact that patients prescribed rosiglitazone alone suffered from more chronic diseases compared with those prescribed pioglitazone alone or for the fourfold higher rate of kidney impairment in the TZD patient group. In addition, it notes that the ICES analysis included insulin therapy within the TZD combination group and excluded insulin combinations within the comparison group, which biases the TZD combination group toward increased cardiovascular risk relative to the comparison group.

Nissen described the company's statement as "predictable." He said it was "impossible" to ignore the evidence of increased risk of MI with rosiglitazone, which has been shown in four meta-analyses and now in this independent observational study. "The conclusion that rosiglitazone increases the risk of MI is simply inescapable. The contrary 'evidence' cited by GlaxoSmithKline is not credible. The RECORD trial is an interim report of an ongoing study and the hazard ratio (HR) for MI was 1.23, but with too few events to reach significance. The 'large' GlaxoSmithKline-sponsored observational studies are unpublished and not credible. Finally, the Ontario study is fully consistent with the findings of the meta-analysis of pioglitazone [2] that show no increased risk of MI with pioglitazone," he told heartwire.

Also commenting on the latest results for heartwire, Dr Sanjay Kaul (Cedars Sinai Medical Center, Los Angeles, CA), who coauthored a paper criticizing Nissen's original meta-analysis, said the ICES study was interesting but that the data are not conclusive enough to guide clinical practice. He said: "Case-control observational studies are notorious for introducing biases. Among the methodologic tools that have been developed to minimize bias (confounding) in these studies, propensity-adjusted model with time-varying covariates and adjustment for multiple comparisons is generally considered to be the most robust. I did not see these methods applied to the analysis in this study. The investigators report no statistically significant increase in CHF for pioglitazone, but we know from many other data sources that this agent does increase risk of CHF. The absence of such a finding in their data suggests the likelihood of methodological errors associated with biases that are inherent to analyses of observational data."

The Ontario Ministry of Health and Long-Term Care funded this study. Dr. Lipscombe has received support from the Canadian Diabetes Association, the Canadian Institutes of Health Research, and the New Emerging Team Canadian Institutes of Health Research. Two other study authors have received support from the Canadian Institutes of Health Research and from the Heart and Stroke Foundation of Ontario. One study author has disclosed various financial relationships with INTERxVENT Canada and PrevCan. Another study author has obtained funding.

Sources

Lipscombe LL, Gomes T, Lévesque LE, et al. Thiazolidinediones and cardiovascular outcomes in older patients with diabetes. JAMA. 2007;298:2634-2643.
Lincoff AM, Wolski K, Nicholls SJ, Nissen SE. Pioglitazone and risk of cardiovascular events in patients with type 2 diabetes mellitus: A meta-analysis of randomized trials. JAMA. 2007;298:1180-1188.

The complete contents of Heartwire, a professional news service of WebMD, can be found at www.theheart.org, a Web site for cardiovascular healthcare professionals.

Clinical Context

Cardiovascular disease is an important cause of morbidity and mortality among persons with type 2 diabetes mellitus. Shown to improve glycemic control, the TZDs (rosiglitazone and pioglitazone) are commonly prescribed oral hypoglycemic agents; however, recent concerns have arisen regarding adverse events. TZDs are associated with not only weight gain and edema but also with an excess risk for congestive heart failure and possibly acute myocardial infarction. However, the association between TZD use and cardiovascular events has not been adequately evaluated on a population level.

The aim of this study was to explore the association between TZD therapy and congestive heart failure, acute myocardial infarction, and mortality vs treatment with other oral hypoglycemic agents.

Study Highlights

In this population-based, retrospective cohort study with a nested case-control approach, healthcare databases in Ontario were examined for patients aged 66 years or older with diabetes who were treated with at least 1 oral hypoglycemic agent between 2002 and 2005 (N = 159,026) and observed until March 31, 2006.
The cohort entry date was defined as the date of the first prescription for an oral hypoglycemic agent, including TZDs, metformin, sulfonylureas, and other oral agents.
Patients who received insulin therapy in the year preceding the cohort entry were excluded.
The primary outcome consisted of an emergency department visit or hospitalization for congestive heart failure; secondary outcomes were an emergency department visit or hospitalization for acute myocardial infarction and all-cause mortality.
The risks for these events were compared between persons treated with TZDs (rosiglitazone and pioglitazone) and other oral hypoglycemic agent combinations, after matching and adjusting for prognostic factors.
During a median follow-up of 3.8 years, 12,491 (7.9%) patients had a hospital visit for congestive heart failure, 12,578 (7.9%) had a visit for acute myocardial infarction, and 30,265 (19%) died.
Current treatment with TZD monotherapy was associated with a significantly increased risk for congestive heart failure (78 cases; adjusted rate ratio [RR], 1.60; 95% confidence interval [CI], 1.21 - 2.10; P < .001), acute myocardial infarction (65 cases; RR, 1.40; 95% CI, 1.05 - 1.86; P = .02), and death (102 cases; RR, 1.29; 95% CI, 1.02 - 1.62; P = .03) vs other oral hypoglycemic agent combination therapies (3478 cases of congestive heart failure, 3695 cases of acute myocardial infarction, and 5529 deaths).
The increased risk for congestive heart failure, acute myocardial infarction, and mortality associated with TZD use seemed to be limited to rosiglitazone.
The baseline event rates in the 4-year follow-up were 9.54% for congestive heart failure, 9.67% for acute myocardial infarction, and 19.33% for death.
Overall, the estimated numbers needed to harm for 4 years were 34 (95% CI, 21 - 52) for congestive heart failure, 26 (95% CI, 12 - 105) for acute myocardial infarction, and 22 (95% CI, 13 - 47) for death.
Limitations of this study included potential misclassification of some exposures, covariates, and outcomes; selection bias in the findings; lack of identification of TZD use paid for by patients within the cohort; and the TZD-treated population possibly representing an older and more select population of patients with more advanced diabetes.

Desmopressin Nasal Spray No Longer Indicated for Bed-Wetting

2007-12-12T17:37:12Z

Desmopressin acetate intranasal formulations are no longer indicated for the treatment of primary nocturnal enuresis (PNE) because of the risk for severe hyponatremia that can lead to seizures and death, the US Food and Drug Administration (FDA) warned healthcare professionals yesterday.

These formulations are currently marketed as DDAVP (sanofi-aventis US, LLC), Minirin (Ferring Pharmaceuticals, Inc), and Stimate (CSL Behring, LLC).

]]> The change was based on a review of data from 61 postmarketing cases of hyponatremia-related seizures, 2 of which resulted in death. A large percentage of these cases (41%) occurred in pediatric patients younger than 17 years receiving intranasal desmopressin, most commonly for PNE.

Although desmopressin tablets may still be used for PNE, this therapy should be interrupted during acute illnesses that can lead to fluid and/or electrolyte imbalance, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program. Such events can include fever, recurrent vomiting/diarrhea, vigorous exercise, and other conditions that increase water consumption.

The FDA also emphasized that fluid intake should be restricted from 1 hour before to 8 hours following dose administration and that all desmopressin formulations should be used cautiously in patients at risk for water intoxication with hyponatremia. Risk factors include habitual or psychogenic polydipsia and use of medications such as tricyclic antidepressants and selective serotonin reuptake inhibitors. Of the 61 postmarketing cases, the majority (64%) occurred in patients with at least 1 factor (drug or disease) predisposing them to hyponatremia or seizures.

Desmopressin nasal spray, rhinal tube, injection, and tablets are indicated as antidiuretic replacement therapies for central cranial diabetes insipidus and for the management of temporary polyuria and polydipsia following head trauma/surgery in the pituitary region.

Desmopressin injection also is indicated to prevent or stop excessive bleeding in patients with hemophilia A and for mild to moderate classic von Willebrand's disease in patients with factor VIII coagulant activity levels more than 5%.

Healthcare professionals are encouraged to warn patients and caregivers regarding the need to monitor water intake while receiving desmopressin therapy, particularly when taking concurrent medications that increase dry mouth, during hot weather or following strenuous exercise that increases thirst, and during periods of illness with severe vomiting/diarrhea or fever.

Adverse events related to use of desmopressin should be communicated to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

source

GlaxoSmithKline reportedly threatened diabetes expert over Avandia warnings

2007-11-28T14:58:19Z

by David Gutierrez

(NewsTarget) A diabetes expert has claimed that pharmaceutical company GlaxoSmithKline threatened him with legal action after he raised concerns about the safety of the company's anti-diabetes drug rosiglitazone, marketed as Avandia.

In a written testimony to a congressional subcommittee, John Buse of the University of North Carolina said that he received phone calls from company executives in 1999, just after Avandia's release, warning him that his comments about the drug "were scurrilous enough to attempt to hold me liable for a loss in market capitalization." Buse later signed a statement, drafted by GlaxoSmithKline, attempting to alleviate the concerns that his comments had raised with stockholders.]]> GlaxoSmithKline's CEO J.P. Garnier has denied that the company made any threats, saying instead that Buse made a "correction" to his prior comments.

In March 2000, Buse -- who is expected to become the next president of the American Diabetes Association -- warned the FDA that Avandia might increase users' risk of heart attacks. He also publicly criticized the company's "blatant selective manipulation of data," which he said functioned to make the drug appear more effective and less dangerous.

Buse's recent comments were directed to the House Committee on Oversight and Government Reform, which is investigating the FDA's role in approving Avandia. The committee convened a hearing on the issue after the New England Journal of Medicine announced that it would be publishing a study linking Avandia use to increased cardiovascular problems. The study, published on June 14, found that the drug led to a 43 percent higher risk of heart attack and a 64 percent higher risk of heart death.

As a result, Congress is investigating why the early warnings given by Buse and the World Health Organization were not heeded in the FDA approval process.

The FDA's process for approving new drugs has come under increasing fire recently, spurred on by scandals such as the discovery that Merck's popular anti-inflammatory Vioxx led to increased risk of heart attack and stroke.

source

U.K. drug giant buys vaccine firm

2007-04-24T14:24:53Z

LONDON–AstraZeneca PLC said yesterday it is buying U.S.-based biotech drug maker MedImmune Inc. in a $15.6 billion (U.S.) deal that will allow the British company to enter the vaccines market.

AstraZeneca, looking to strengthen its pipeline of future drugs as it faces patent challenges and escalating generic competition, will pay $58 per share for MedImmune, a 21 per cent premium to the stock's close Friday.

The deal, which AstraZeneca hopes to close in June, will increase the company's proportion of biotechnology drugs in its pipeline to 27 per cent from 7 per cent, and enlarge its total pipeline by 45 projects to 163 projects.

]]> This includes two late-stage products being developed by Maryland-based MedImmune, which has more than 2,500 employees.

One product is the follow-up to MedImmune's flagship childhood respiratory drug Synagis. The second is a refrigerated formulation of its FluMist inhaled influenza vaccine, which may be launched for the winter.

Pharmaceutical companies are turning to vaccines because the market has few producers and a reduced risk of generic competition. Interest was spurred by the emergence of the deadly strain of bird flu in Asia with no vaccine to protect against it.

AstraZeneca released first-quarter results yesterday, two days earlier than expected. Revenue rose 13 per cent to $6.97 billion.

(c) Associated Press

Analysis: Senate committee approves drug safety bill, but FDA still runs on Big Pharma money

2007-04-24T14:08:21Z

by Mike Adams, NewsTarget.com

The U.S. Senate Health, Education, Labor and Pensions Committee voted 15-5 to approve a bill that aims to strengthen FDA oversight of drug company advertising and post-approval follow-up studies. The bill was sponsored by Wyoming Republican Sen. Mike Enzi and Massachusetts Democrat Sen. Edward Kennedy. The primary motive for the bill is to give the FDA more power to stop a future Vioxx disaster from being repeated.

The Bush Administration is against the bill and offered sharp objections to the bill's provisions, saying it would slow down drug approvals. Republicans also argued that the banning of drug advertisements on television was "unconstitutional."

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Allow the FDA to fine drug companies that fail to conduct post-approval safety studies.
Allow the FDA to ban advertising of new drugs for two years after their initial approval.
Allow the FDA to review the safety of newly approved drugs 18 months after approval, and then again at 36 months (three years).
Raise the amount of money paid to the FDA by drug companies for the review and approval of their drugs.

Analysis, commentary and satire by Mike Adams

Okay, let's get to the real story here. The bill has good intentions, but even if it passes, it still leaves the FDA fully in charge of a medical monopoly, paid and influenced by drug companies, and does nothing to outlaw direct-to-consumer drug advertising.

Relevant facts about the FDA and Big Pharma:

The FDA is funded in part by the drug companies themselves. Employees who work at the FDA know that drug companies ultimately help fund their paychecks. This creates a dangerous level of collusion between a regulator and the industry it claims to regulate, turning it into a business / customer relationship. This is one reason why the FDA is so eager to please Big Pharma: That's who's paying (part of) the FDA salaries!

The United States is the only advanced nation in the world that allows drug companies to advertise directly to the public. It is a dubious practice that has no scientific or medical justification whatsoever. It was legalized in 1998 by the FDA and contributed directly to the Vioxx fiasco as well as the mass medication of American children with mind-altering drugs. Drug advertising should be banned outright. A two-year ban is better than nothing, but an outright ban is the only reasonable resolution of this issue.

Just because this new Senate bill would "allow" the FDA to fine drug companies for failing to conduct follow-up safety studies doesn't mean the FDA will actually do so. Much of the language in this bill assumes the FDA actually desires to regulate drug companies and protect the American public. Yet past behavior by the agency has proven the FDA has very little interest in protecting the public. Thus, any "optional" language in the bill may ultimately be useless. A good bill would require the FDA to take specific actions, levy certain fines, and oversee the necessary safety studies.

The fact that the Bush Administration is speaking out strongly against this bill is an indication that it's a step in the right direction. Big Pharma has strong financial ties to the Bush Administration and its top officials. Any proposed law that would tighten safety requirements and dampen the advertising and promotion of medications would suppress the profits of drug companies. Hence, Republicans are arguing against the bill in order to protect their campaign supporters -- the drug companies.

The Republican argument that banning drug advertising on television would be "unconstitutional" tells us all just how quickly and easily some Republicans have forgotten what the Constitution really says. Freedom of Speech does not protect the right to harm (and ultimately kill) American citizens through a mass campaign of false advertising that promotes deadly products to people who are being tricked into thinking they really need them.

Humorous observation: Some lawmakers no doubt think that the Fourth Amendment, which protects us from "unreasonable searches and seizures," must be referring to anti-seizure medications.

Doing a poor job? Just ask for a raise...

Whose idea was it anyway that the FDA is doing such a fine job with regulating the drug companies that it deserves to be paid even MORE money by Big Pharma? It's certainly nothing new in Washington: The worse you do the job, the more money you get.

But the idea is ludicrous. Why should the FDA be even more financially beholden to drug companies than it is already? Shouldn't we be trying to extricate the FDA from drug company influence and let the agency stand on its own, funded with public money, and operating on some sort of sworn oath to protect the consumer?

If things were set right, the FDA should be Big Pharma's worst enemy. The FDA should be hammering drug companies with stringent safety requirements, skeptical thinking about drug benefits claims and huge fines for those companies that get caught conducting fraudulent science or burying the results of drug studies they don't want the public to see. To be really effective, the FDA needs:

Complete independence from Big Pharma. This means the agency must run on public funds only and receive no money from the industry it claims to regulate.
A new set of scary teeth. The FDA needs to be able to take strong action against drug companies by levying fines, banning dangerous drug products and even confiscating pharmaceutical inventory. Don't you find it curious that the FDA has raided lots of vitamin companies and confiscated countless truckloads of nutritional products, but has never (to my knowledge) conducted an armed raid on a major pharmaceutical company and confiscated the brand-name prescription drugs that are actually killing people?

The truth is, the FDA treats Big Pharma with kid gloves. It even "negotiates" with drug companies to decide on how, and when, and at what size safety warning labels should be printed. This is absurd, and it shows who's really in charge when it comes to drug safety (the drug companies themselves!).

Then again, all this assumes the FDA actually wants to protect the public, and I don't believe the agency wants to. I think the FDA just pretends to protect the public in order to meet the minimum regulatory requirements that prevent a real Congressional inquiry. The FDA seems to be merely going through the motions of regulating drug companies, without actually pursuing the task with any genuine sense of purpose.

It's like an empty shell of a government regulator. It might as well be renamed to, "The Big Pharma Administration." Because that's where much of the money comes from, and that's where the interests of the top decision makers seem to be focused.

Kudos to Wyoming Sen. Mike Enzi for having the courage to co-sponsor this bill. I've personally met Sen. Enzi, and he's among the most progressive, energetic Republicans you'll find in the Senate. It must have taken really political courage for him to put his name on such a bill, knowing that the leaders of his own party would line up so strongly against him on this issue.

For Senator Kennedy, the decision was probably a little easier. Democrats are increasingly aligned against Big Pharma, and there's broad support in the Democratic party for some sort of major health care reform that would likely involve major FDA reforms at the same time.

But they both deserve credit for trying to move this bill forward. It's not the bill that I want, but it's a bill that's better than what we have right now. It's a step in the right direction, and sometimes that's all you can realistically hope for in Washington.

In case anybody out there is interested in REAL reform that would rein in the drug companies and protect consumers, here are the top five things that need to be done:

The top five reforms we really need

Ban all direct-to-consumer drug advertising. It never should have been legalized in the first place. There is no logical medical argument that justifies the practice of promoting prescription drugs directly to consumers.
Fund the FDA entirely with public money. It's crucial to disconnect the FDA from the purse strings of Big Pharma. FDA funding should come from those it answers to: the taxpayers.
Make the reporting of drug side effects mandatory. When doctors or drug companies learn about a patient experiencing a side effect, it should be mandatory to report that side effect to the FDA.
Require the open publication of all drug studies. Currently, drug companies hide the studies they don't want you to see, and they only publicize the (fraudulent) studies that produce the results they like. We need to change this and shine some light on the results of ALL clinical trials to let doctors, patients and everyone else examine the science for themselves. (The pharmaceutical industry argues venomously against this. They think drug studies should be kept secret.)
End conflicts of interest at the FDA. Require, by law, that anyone who works for the FDA, advises the FDA or participates in FDA decision processes has no financial ties whatsoever to drug companies or medical device makers. No consulting fees, bribes, stock options or incentives. The people who make decisions about the safety of the drugs approved in this country should have no financial ties to the companies impacted by their decisions. It's common sense.

Pretty simple, huh? Five reforms that would restore some honesty and integrity to the FDA.

Protecting consumers from dangerous drugs is really not that difficult. The necessary reforms are easy to see. It's just that drug companies have their financial tentacles wrapped around so many legislators that real reforms are politically strangled to death before they have a chance to get voted on ("killed in committee"). With some notable exceptions, Congress has been bought out by Big Pharma. Wholesale, meaningful reform is currently not even being debated. The only things being talked about are changes so tiny that it's like pointing a rowboat two degrees to the left as it floats aimlessly in a sea of corruption.

Is it a step in the right direction? Sure it is.

Is it a real solution to FDA corruption and Big Pharma influence over conventional medicine? Not even close.

Safety information about Genentech's Avastin lung cancer drug

2007-04-24T14:04:58Z

Genentech and FDA notified healthcare professionals of important new safety information regarding tracheoesophageal (TE) fistula formation in a recent clinical study in patients with limited-stage small cell lung cancer (SCLC).

This multicenter, non-randomized, single-arm phase II clinical trial study combined chemotherapy and radiation plus Avastin.

There have been two confirmed serious adverse events of TE fistula (one fatal) reported in the first 29 patients enrolled in this study. A third, fatal event (upper aerodigestive tract hemorrhage and de ath of unknown cause), was also reported, in which TE fistula was suspected but not confirmed. All three events occurred during the Avastin maintenance phase of the study in the context of persistent esophagitis. Additionally, six other cases of TE fistula have also been reported in other lung and esophageal cancer studies using Avastin and chemotherapy alone or with concurrent radiation treatment.]]> Avastin is not approved for the treatment of SCLC. The current prescribing information includes a description of gastrointestinal tract fistula formation in patients with colorectal cancer and other types of cancer treated with Avastin. Genentech intends to revise the Avastin package insert to include more detailed information regarding the incidence of all cases of fistula in patients treated with Avastin.

Disclosure Laws Do Not Fully Reveal Drug Company Payments to Physicians

2007-03-28T21:39:24Z

NEW YORK (Reuters Health) Mar 20 - Laws that mandate disclosure of payments to physicians by pharmaceutical companies provide limited public information, according to a new report.

At present, five states and the District of Columbia have legislation requiring payment disclosure. Among these states, Minnesota and Vermont require that the information be made available to the public.

In the current study, reported in the March 21st issue of the Journal of the American Medical Association, Dr. Joseph S. Ross, from Mount Sinai School of Medicine in New York, and colleagues examined the accessibility and quality of information provided by the disclosure laws in Minnesota and Vermont.

]]> The analysis included data from January 2002 to December 2004 in Minnesota and from July 2003 to June 2004 in Vermont.

The researchers found that obtaining the payment information was not easy. In Vermont, extensive negotiation with the Office of the Attorney General was needed, while in Minnesota, manual photocopying of individual disclosure forms at the State Board of Pharmacy was required.

Missing disclosure information was common in both states.

In Vermont, 61% of payments were not released to the public because the drug companies classified them as revealing trade secrets and 75% of disclosed payments lacked information to identify the recipient.

In Minnesota, just 25% of drug companies reported payment information in all three years of the study.

Quite large payments to physicians were commonplace, the report indicates. In Vermont, 2416 of the 12,227 payments studied were each at least $100, amounting to a total of $1.01 million; the range was $100 - $20,000 and the median payment was $177. In Minnesota, such payments were even more common: 6238 of 6946 payments were at least $100 (ranging up to $922,239, with a median payment of $1000), and these amounted to $22.39 million.

In a related editorial, Dr. Troyen A. Brennan, from Aetna Inc. in Hartford, Connecticut, and Michelle A. Mello, from Harvard School of Public Health in Boston, comment that pharmaceutical companies' "primary commitment is to create shareholder value, not maintain an altruistic commitment to patients. But at some point the leadership of the pharmaceutical industry and their board of directors must begin to recognize that growing public and professional mistrust could substantially detract from that value."

source - Medscape

Pfizer Ordered to Withdraw Advertising

2007-03-08T20:57:38Z

LONDON, March 7, 2007-The Medicines and Healthcare products Regulatory Agency (MHRA) has requested Pfizer to withdraw an advertisement making potentially misleading claims about Zyvox (linezolid), an antibiotic used to treat certain types of serious infection.

The MHRA became aware of the advertisement in the British Medical Journal (BMJ) claiming that Zyvox has superior cure rates compared to products containing the active ingredient vancomycin. At the time, Pfizer was in discussion with the MHRA about emerging concerns relating to the efficacy and safety of Zyvox compared to vancomycin in a clinical trial in patients with catheter-related infections.

]]> Pfizer wrote to healthcare professionals this week to inform them about new safety restrictions on the use of Zyvox.

Dr June Raine, Director of Vigilance and Risk Management of Medicines at the MHRA, said:
“Advertising is an important means of communication and for medicines it can provide useful information to the public and healthcare professionals about available treatments and their potential benefits. Companies must take a responsible approach to safety in their advertising in light of the risks and benefits of their product.”

“The MHRA continually monitors the safety of all medicines and takes action to minimise any risks that are identified. The monitoring of advertising is no less important, and the MHRA will not tolerate medicines advertising that creates unrealistic expectations or is misleading.”

Notes to Editor

The MHRA is the government agency that is responsible for ensuring that medicines and medical devices work, and are acceptably safe. We keep watch over medicines and devices, and we take any necessary action to protect the public promptly if there is a problem. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks.

Anyone who has concerns about misleading advertising of medicines should contact the MHRA Advertising Unit, 14-112, Market Towers, Vauxhall, London SW8 5NQ or phone 020 7084 2000. Alternatively, contact the pharmaceutical self-regulatory bodies, the Proprietary Association of Great Britain (PAGB) for advertising for over the counter medicines, or the Prescription Medicines Code of Practice Authority (PMCPA) for advertisements to health professionals for prescription medicines.

More information can be found on our website under http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=165

Senators promise drug importation push

2007-03-08T20:55:12Z

U.S. senators vowed on Wednesday to move forward with legislation to legalize the importation of cheaper prescription drugs from certain countries, despite resistance from regulators and drugmakers.

One Democrat and three Republicans said their plan would provide money and safeguards for the Food and Drug Administration to assure the imports were not dangerous.

"I believe this legislation puts in place an effective regulatory framework to make importation of FDA-approved drugs safe for consumers," Sen. Byron Dorgan (news, bio, voting record), a North Dakota Democrat, said at a hearing.

]]> Dorgan said the goal was to "create a little competition in the marketplace so we can put a real downward pressure on prescription drug prices."

The legislation would allow consumers, pharmacies and wholesalers to purchase FDA-approved medicines sold in Canada and other industrialized countries. Congress would provide money so the FDA could make sure the medicines and manufacturing sites met agency standards, supporters said.

One-third of senators already have backed the bill, said Dorgan, who chairs a subcommittee of the Senate Commerce, Science and Transportation Committee.

Many Americans already have bought medicines from abroad, often through Internet pharmacies, even though the practice is illegal.

The FDA has warned against congressional efforts to legalize importation, arguing the agency cannot vouch for drugs purchased from foreign sources.

Randall Lutter, acting deputy FDA commissioner for policy, said the agency remained "immensely concerned about unapproved, imported pharmaceuticals whose safety and effectiveness cannot be assured."

Importation backers told Lutter they were skeptical the FDA could not find ways to certify imported drugs when the agency allows a wide range of foods into the country.

"I don't understand at all why FDA, given the resources ... cannot do what others in the world can do," Dorgan said.

Republicans echoed Dorgan's view.

"It is doable, it is reasonable and I think, frankly, the time has come," said Maine Sen. Olympia Snowe (news, bio, voting record).

Lutter said the FDA would need to verify drugs bought overseas were safe, effective and equivalent those sold in the United States. That would require "a major expansion" of the agency's duties, he said.

Billy Tauzin, head of the Pharmaceutical Research and Manufacturers and America, said legalizing widespread importation would increase the chances of counterfeit drugs being sold to Americans.

"I just want to warn you ... one day we will rue the day we opened up that door," he said.

Study shows near-tripling of global ADHD drug use

2007-03-07T12:03:11Z

The use of drugs to treat attention-deficit/hyperactivity disorder, or ADHD, has more than tripled worldwide since 1993, U.S. researchers reported on Tuesday.

And spending on such drugs rose nine-fold between 1993 and 2003, the team at the University of California, Berkeley reported.

"ADHD could become the leading childhood disorder treated with medications across the globe," Richard Scheffler, an expert in health economics and public policy who led the study, said in a statement.

]]> "We can expect that the already burgeoning global costs for medication treatment for ADHD will rise even more sharply over the next decade."

Roughly one in 25 U.S. children and adolescents is taking medication for ADHD, the researchers found.

They used an international pharmaceutical database to examine data from nearly 70 countries. In 1993, 31 countries used ADHD drugs, but by 2003 that number had risen to 55, they found.

France, Sweden, Korea and Japan all showed increases in ADHD drug use among 5- to 19-year-olds.

"The usage of ADHD medications increased 274 percent during the study period," Scheffler's team wrote in the journal Health Affairs.

The United States led the pack, accounting for 83 percent of the prescriptions and $2.4 billion in 2003. Canada and Australia also had much heavier use than the researchers predicted.

ADHD is marked by poor concentration, distractibility, hyperactivity, impulsiveness and other symptoms beyond what might be expected for the patient's age.

Amphetamine drugs can control the symptoms, but their use is sometimes controversial.

Methylphenidate, sold under the brand name Ritalin by Novartis, was once the standard. But costly and long-acting medications like Johnson & Johnson's Concerta, Strattera, made by Eli Lilly and Co., and Adderral XR, made by British drugmaker Shire Plc, are now driving up costs, the researchers said.

"Costs are likely to rise globally as long-acting medications, which offer easier use and result in better compliance, become more prevalent outside the U.S.," said Dr. Peter Levine, a pediatrician with Kaiser Permanente in Walnut Creek, California.

Psychologist Stephen Hinshaw of UC Berkeley said "cross-cultural research has shown that ADHD exists in all cultures, with increased access to public education a factor in its detection."

The researchers recommended that countries keep tabs on the use of ADHD drugs and make sure their benefits are worthwhile.

Taking the Wraps Off Drug Safety Data From Clinical Trials

2007-03-07T12:00:47Z

BOSTON, MA -- March 6, 2007 -- For years, pharmaceutical companies have sought to restrict public access to drug safety data collected in clinical trials on the basis that it is proprietary information, arguing that competitors could use that information in the development of their own products. However, a number of recent cases of drugs found to have dangerous side effects after coming to market, such as the anti-inflammatory drug rofecoxib (Vioxx), have raised concerns about safety data being treated as confidential.

A new analysis by researchers at the Harvard School of Public Health and Brigham and Women's Hospital of laws and regulations governing public disclosure of clinical trial data submitted to the FDA suggests changes should be made to the way the FDA implements its policy regarding the confidentiality of those data. Allowing greater access to safety data would enable researchers to independently evaluate risks, resulting in more timely risk detection. The review and commentary appears in the current issue of Health Affairs.]]> The Vioxx case and other drug safety cases have demonstrated the value of making these data available to researchers," said co-author Aaron Kesselheim, MD, Department of Pharmacoepidemiology at Brigham and Women's Hospital and an attorney.

Currently, pharmaceutical manufacturers submit clinical trial data, which establish the safety and efficacy of their products, to the FDA as part of the drug application process. However, after the agency approves a New Drug Application (NDA), it does not release a full report of the safety and efficacy data. Rather, it releases a summary of the clinical data section of the NDA (called the Summary Basis of Approval), and FDA regulations allow the drug manufacturer to draft the Summary. The process reflects an understanding by the FDA that safety and efficacy information should be protected, so that competing manufacturers can't use those data to develop generic alternatives or competing drugs.

Consumer groups have brought lawsuits against the FDA under the Freedom of Information Act to obtain safety data; these have had mixed results. Lawsuits are not an ideal vehicle for consumer groups and researchers to gain access to data, given that litigation is expensive and cases can take years to move through the legal system.

The commentary authors, Kesselheim and Michelle Mello, an associate professor of health policy and law at the Harvard School of Public Health, believe that making drug safety data public rarely presents a risk to a pharmaceutical company's confidential research and development efforts. "The legal question is whether the information will give other drug companies an unfair competitive advantage," said Mello. "But it is strange to argue that evidence that a drug is harmful will enable others to develop similar drugs." The authors suggest that current FDA policies can and should be changed in ways that allow the scientific community access to safety data before and after an NDA is approved. They offer a number of recommendations, including:

Placing a heavier burden of proof on companies to show competitive harm if data are released.
Replacing the current Summary Basis of Approval with a more comprehensive public document that includes all safety data.
Getting Congress to pass legislation requiring public disclosure of safety data if the FDA fails to take action.

"Safety data from drug clinical trials have important ramifications for public health," said Kesselheim. "The government should do as much as it can to ensure full disclosure of the information."

SOURCE: Harvard School of Public Health

European Commission to revamp drug safety monitoring system

2007-03-01T13:35:57Z

"Although the current pharmacovigilance system is good and safe, there are now more countries in the EU, and therefore there is a need for an improved system," Ton Van Lierop, a Commission spokesperson told In-PharmaTechnologist.com.

The move comes hot on the heels of a consultation conducted by the Commission last year which found that that the current system is "contradictory, confusing, unclear and complex."

The feedback from the consultation suggested that there are complex reporting rules implemented differently by different EU member States, a lack of robust safety studies and complex decision-making at EU-level.]]> The vast majority of respondents, which included industry players, regulators, patient groups and other stakeholders, argued that the drug safety monitoring (pharmacovigiliance) system needs to be "strengthened and rationalised".

They called for a change to the legal framework in the EU, highlighting that the fact that the different member states have slightly different rules is detrimental to public health.

"We will improve and strengthen the monitoring of the safety of medicines so that safety issues are rapidly detected, and effectively dealt with based on more robust data," said Günter Verheugen, the Commission vice-president responsible for enterprise and industry policy.

"Rationalisation of the EU medicines safety system will free up resources which can then be directed to better protecting the health of EU citizens."

However, Commission spokesperson Van Lierop couldn't give a figure on how much the improvement of the system would cost.

For drugs evaluated by the European Agency for the Evaluation of Medicinal Products (EMEA) and authorised by the European Commission, the funding is separated and is public – as opposed to the drug review process, where three quarters of the budget come from industry fees.

Before it is approved to be launched on the EU market, a new drug has to undergo extensive studies to demonstrate that it is safe, of high quality and effective.

However, it is impossible to predict a medicine's potential adverse reactions prior to it being authorised because of the limitations of clinical trials, and sometimes safety issues are detected once a drug is on the market.

That is exactly where post-market studies and pharmacovigilance are important.

The Commission's new proposals include more funding of studies into the safety of medicines as well as studies into the methodologies used to conduct pharmacovigilance.

A better collaboration between EU members and a higher utilisation of the EU safety monitoring database "Eudravigilance" is also wished for, as well as the implementation of standards – "Good Vigilance Practices – GVP" – by both the industry and regulators.

The Commission also recommends clarifying the roles and responsibilities of member states and the European regulator.

The change to the legal framework will involve an impact assessment during the course of 2007 with a view to a legal proposal in 2008.

source Outsorcing Pharma

For Merck, A New Worry Amid Success

2007-03-01T13:32:15Z

Worries are emerging about the safety of new diabetes medicines Januvia and Galvus, drugs expected to be big sellers for makers Merck and Novartis. But it is unclear if the concerns are justified or just the result of a hair-trigger tendency concerning drug safety on the part of doctors and regulators.

On Monday, Novartis said the U.S. Food and Drug Administration wants it to run a new safety study of Galvus. Analysts say that could take another year; the pill has already been delayed for three months.

That follows a Feb. 1 article in The New England Journal of Medicine that questioned the safety data available for these drugs. David M. Nathan, a Harvard Medical School endocrinologist, wrote that it is "surprising" that the FDA decided to clear Januvia at all, given the "paucity of published data from long-term clinical trials on its safety and efficacy." Nathan, who is a consultant for Novartis and other drug makers but not Merck , did not return requests for comment.

]]> The concerns represent a delicate situation for Merck, which has undergone a resurgence under Chief Executive Richard Clark. It rushed Januvia to market, pulling past Novartis after a late start. Now it will reap profits from Novartis' delay, booking an additional $130 million this year and $300 million next year, according to Timothy Anderson of Prudential Equity Group. Wednesday morning, Merck boosted its earning forecasts for the year by 4%, based on strong performance of its drugs. It also unveiled promising late-stage data on an AIDS drug that is expected to hit the market this year.

But the withdrawn pain pill Vioxx, for which Merck is still facing thousands of lawsuits, is a reminder that problems with one company's drug can hurt rivals as well. When Merck yanked Vioxx, investors at first thought Pfizer, which made rival drugs Celebrex and Bextra, would profit. Instead, Bextra wound up off the market as well, and Celebrex struggled for years before regaining its footing.

"We continue to actively monitor the safety of Januvia, as we do for all of our products,” Merck said in a statement. “The labeling for Januvia accurately reflects the safety profile of the product."

Januvia and Galvus are the leaders of a new class of medicines called DPP-4 inhibitors, which block an enzyme (dipeptyl peptidase 4). This enzyme normally breaks down a peptide, called GLP-1, that helps the body break down blood sugar. DPP-IV drugs are supposed to help patients control their diabetes with fewer side effects than older medicines. Nobody is pointing to an actual problem with these drugs, but some worry that potential problems have not been ruled out.

Merck's Januvia was approved after studies in 2,700 patients. James Underberg, a cardiologist at the New York University Medical Center who participated in trials of Januvia, says that the concern that the drug has been studied in only a limited number of patients is real, and that doctors should be cautious with new drugs. But he says Januvia is an important option for diabetes patients who cannot tolerate existing medicines because of side effects like diarrhea, weight gain and swelling.

"A lot of the medicines we currently have are difficult for people to take," Underberg says. "No one is saying this should be a first-line drug, but if you're a diabetic who is spiraling downward, you are grasping at straws." Underberg is a paid speaker for Novartis.

There are several potential concerns about DPP-4 drugs, clear evidence of them has not turned up in clinical trials so far. In theory, the medicines could affect the immune system, because a receptor on immune cells is very similar to DPP-4. In studies of monkeys, Galvus and another DPP-4 inhibitor being developed by Bristol-Myers Squibb and AstraZeneca have caused skin lesions. Merck says that its studies have not turned up this side effect, and that Januvia was designed to bind only to the DPP-4 enzyme, reducing the chances of these side effects.

Merck says its tests of DPP-4 inhibitors that also hit related enzymes turned up the side effect in monkeys where its own experiments did not. The company says that this research is continuing and that it is carefully monitoring the results.

It is not entirely clear how these safety worries relate to the clinical trial Novartis must conduct. On a conference call, James Shannon, the drug giant's head of clinical research, said the FDA wants more data studying Galvus in patients with impaired kidneys. It had been thought that Galvus might eke a marketing advantage over the fact that it is not processed by the kidneys, while Januvia is. But another molecule created when the body metabolizes Galvus does build up in the kidney.

Even if the trial is not specifically designed to look at either skin or immune system side effects, it is likely to turn them up if they exist. Patients with impaired kidneys have more of the drug in their bloodstream and would be more likely to experience side effects.

In a conference call with financial analysts, Shannon noted that the FDA division that is handling the Januvia application has been hit by a series of safety scandals.

Seven years ago, Rezulin, a Pfizer diabetes drug, was pulled from the market. In the past several months, studies of Actos and Avandia, from Takeda Pharmaceutical and GlaxoSmithKline, have failed to alleviate safety concerns with those drugs. A letter was recently sent to physicians involving Avandia's tendency to lead to osteoporosis. Then came Nathan's piece in the New England Journal. Two weeks ago, members of this division appeared in front of Congress to defend their handling of a failed diabetes drug developed by Bristol and Merck.

source Forbes

Prescription abuse to pass illicit drugs

2007-03-01T13:28:45Z

Abuse of prescription drugs is about to exceed the use of illicit street narcotics worldwide, and the shift has spawned a lethal new trade in counterfeit painkillers, sedatives and other medicines potent enough to kill, a global watchdog warned Wednesday.

Prescription drug abuse already has outstripped traditional illegal drugs such as heroin, cocaine and Ecstasy in parts of Europe, Africa and South Asia, the U.N.-affiliated International Narcotics Control Board said in its annual report for 2006.

In the United States alone, the abuse of painkillers, stimulants, tranquilizers and other prescription medications has gone beyond "practically all illicit drugs with the exception of cannabis," with users increasingly turning to them first, the Vienna-based group said.

]]> Unregulated markets in many countries make it easy for traffickers to peddle a wide variety of counterfeit drugs using courier services, the mail and the Internet.

"Gains over the past years in international drug control may be seriously undermined by this ominous development if it remains unchecked," Narcotics Control Board President Philip O. Emafo said.

Discount medications that seem to be authentic often turn out to be powerful knockoffs concocted from recipes posted on the Web, he added.

"Instead of healing, they can take lives," Emafo said, characterizing the danger as "real and sizable."

Up to 50 percent of all drugs taken in developing countries are believed to be counterfeit, the board said, citing estimates from the World Health Organization.

Buprenorphine, an analgesic, is now the main injection drug in most of India, and it is also trafficked and abused in tablet form in France, where the Narcotics Control Board estimates 20-25 percent of the drug sold commercially as Subutex is being diverted to the black market.

The number of Americans abusing prescription drugs nearly doubled from 7.8 million in 1992 to 15.1 million in 2003, the Narcotics Control Board said. Among their prescription drugs of choice: the painkillers oxycodone, sold under the trade name OxyContin, and hydrocodone, sold as Vicodin and used by 7.4 percent of college students in 2005.

Although the number of U.S. high school and college students abusing illicit drugs declined in 2006 for a fourth consecutive year, "the high and increasing level of abuse of prescription drugs by both adolescents and adults is a serious cause for concern," it said.

Counterfeiters are exploiting intense demand for prescription drugs that can give a "high" comparable to cocaine, heroin or methamphetamine, the watchdog group said.

It singled out Scandinavia, where demand for flunitrazepam — a sedative sold as Rohypnol and widely known as a "date rape drug" — increasingly is being met by unauthorized production, and North America, where widespread abuse of prescription drugs, including the narcotic fentanyl — 80 times as potent as heroin — has been blamed for a spike in deaths.

"The very high potency of some of the synthetic narcotic drugs available as prescription drugs presents, in fact, a higher overdose risk than the abuse of illicit drugs," Emafo said.

Exact figures were unavailable, he said, because few countries "are aware to what extent drugs are being diverted and abused" and are not tracking the trend. Nations should pay closer attention and share data on counterfeit drug seizures, the group urged.

Other findings in the annual report:

• Cultivation of opium poppy in Afghanistan hit a record high last year, the Narcotics Control Board said, echoing assessments by the U.S. government and the U.N. Office on Drugs and Crime. "The drug control situation in Afghanistan is deteriorating," the report said, criticizing a proposal to legalize cultivation as "simplistic, not feasible and based on the wrong premise."

• Iran has emerged as the world's No. 1 abuser of opiates, and 2.8 percent of the population now uses illicit cocaine and heroin, most of it from Afghanistan. Emafo said the Iranian government "is aware of the problem ... (and) is taking appropriate action to protect the health of its citizens."

• Bolivia plans to introduce a drug control policy that would broaden the marketing and use of coca leaves — a step the Narcotics Control Board warned could violate international drug conventions. The Bolivian mission to the U.N. in Vienna lodged a protest Wednesday, insisting the country has a right to commercially produce coca for legal products such as flavoring.

• The Narcotics Control Board defended its opposition to so-called "safe injection rooms," where addicts are given clean needles. In Germany and other European nations, such centers have been credited with helping curb the spread of AIDS. "We do not believe in injection rooms," Emafo said. "That cannot be treatment ... this is not healthful."

___

On the Net:

International Narcotics Control Board, http://www.incb.org

Former FDA Commissioners Suggest Changes For Agency

2007-02-27T14:51:57Z

Recent problems at FDA can be attributed to the lack of consistent, long-term leadership; insufficient resources; and not enough authority to address safety issues, according to four former FDA commissioners who participated Wednesday in a panel discussion at the George Washington University School of Public Health and Health Services, the Newark Star-Ledger reports.

David Kessler, who served as commissioner from 1990 to 1997, criticized the pharmaceutical industry's use of mass-marketing techniques and direct-to-consumer advertising. "The notion that you can come up with a new drug and millions and millions of people take it safely -- the blockbuster -- that is what got us in trouble," Kessler said.

]]> He believes limits should be placed on DTC advertising for prescription medications. Other former officials participating in the panel discussion were Donald Kennedy, commissioner from 1977 to 1979; Frank Young, commissioner from 1984 to 1989; and Jane Henney, commissioner from 1999 to 2001. Young said that FDA's lack of sufficient funding prevents the agency from properly monitoring post-approval drugs. Henney said FDA needs greater authority to order -- rather than negotiate -- label changes and recalls for drugs that appear less safe than initially thought.

Young said, "FDA needs to be a high priority for the administration and the Congress, and the administration must avoid political meddling." In a separate conference held on Wednesday by the Center for Medicine and the Public Interest, current FDA Commissioner Andrew von Eschenbach said that trust in FDA can be regained through "honesty, openness, transparency and a recognition of vulnerabilities," and he also said that "science" will be the foundation for all agency decisions (Cohen, Newark Star-Ledger, 2/22).

via Medical News Today