Drugmakers Hurry Sales, Delay Safety Studies--Gardasil

This demonstrates how pharmaceutical companies gain the FDA seal of approval to market drugs whose safety has not been proven. In other words, consumers are the unwitting test subjects (i.e., guinea pigs) for
prescription drugs that they assume are proven safe because they carry a government seal of approval. Neither consumers nor prescribing physicians are aware that even widely marketed drugs have not met safety standards.

Last year FDA issued a similar notice (below) acknowledging the same ratio of failed compliance with post-marketing safety test requirements by drug and biologics manufacturers.

An example of FDA premature approval for marketing is Merck's new HPV vaccine, Gardasil.

See FDA's letter of approval, Jun 2006:
http://www.fda.gov/cber/approvltr/hpvmer060806L.htm

Note that each paragraph discusses a different element of needed safety evidence that is lacking at time of approval:

*short term safety* *effects on pregnancy*
*evidence whether the vaccine will prevent cancer*
*duration of protective effect* *potential autoimmunity* and
*whether other HPV strains will emerge and take over from the prevented vaccine strains----as happened with the Prevnar pneumococcal vaccine.

Given the track record of manufacturers' non-compliance--as documented in FDA's own review, it is unconscionable that young girls are being FORCED to expose themselves to risks of harm from an insufficiently tested vaccine whose safety is unproven!

What, in addition to $6,000 does the governor of Texas have to gain by issuing an order REQUIRING all Texas 11 year old girls to be vaccinated?

What were the editors of The New York Times thinking of when they congratulated the Texas governor for his irresponsible order?

See: http://ahrp.blogspot.com/2007/02/more-about-mercks-help-pay-for-viox.html

Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org

http://newstandardnews.net/content/index.cfm/items/4269
Drugmakers Hurry Sales, Delay Safety Studies
by Michelle Chen

Feb. 7 - The federal government has admitted that pharmaceutical companies it is supposed to regulate have not yet made good on hundreds of promises to test the safety of drugs already approved for the market.

According to a notice published Friday by the US Food and Drug Administration (FDA), from October 2005 through September 2006, companies had yet to initiate 71 percent of outstanding "post-market" safety evaluations that companies have promised to undertake for currently approved products they are already selling to consumers.

Under the Federal Food, Drug, and Cosmetic Act, the FDA can approve drugs despite unresolved safety concerns, but it can also require further studies by the manufacturer once a drug is released onto the
market.

The FDA reported that of the 1,259 "open post-marketing commitments" tied to already-approved drugs, 899 were still "pending," meaning the studies had not yet begun. Only 15 percent of the studies were currently underway. Another 3 percent were officially behind schedule.

Within the year, only 160 post-marketing commitments were fully concluded with all study requirements met.

Drugmakers are supposed to set schedules for their study commitments and report regularly on their progress. But according to an audit by the inspector general of the US Department of Health and Human Services, the industry's self-reported data are glaringly incomplete. Out of 2,353 drugs with post-market commitments from fiscal years 1990 to 2004, only 6 percent had listed start dates for studies; 21 percent had projected completion dates.

Investigators tried to analyze 145 commitments designated as "fulfilled" in fiscal year 2004, but lacked sufficient data to assess the timeliness of all but 18. Of those, only three were completed within the planned timeframes.

Not all drugs approved by the FDA go through post-market evaluation. Current law allows the FDA to require post-market studies in certain cases - such as when treatments are approved under expedited procedures. For required post-marketing commitments, the FDA can withdraw a product if the manufacturer does not comply with "due diligence."

The agency negotiates other post-market commitments with companies individually, arranging follow-up safety assessments to be conducted after approval. These agreements, however, are not subject to the same enforcement regulations as legally required commitments.

The FDA does not consider "pending" study commitments to be off schedule, arguing that some studies may take a long time to begin due to their complexity. To consumer advocates, however, the latest figures suggest companies can conveniently put off regulatory commitments while profiting from drugs that have not been proved safe.

Bill Vaughan, senior policy analyst with the Consumers Union, told The NewStandard that once a drug is approved, "things move very slowly to resolve unanswered questions, and the public is at risk during that period."

In a 2005 investigation of open study commitments for fast-tracked drugs, the office of Representative Edward Markey (D-Massachusetts) determined that the time the products spent on the market before companies even initiated promised studies was on average 20 months. One drug, the skin treatment Sulfamylon, had been on the market for nearly seven years without the required assessment.

Legislation introduced by Markey in the last Congress would have enabled the FDA to order post-market studies once it received "evidence of a significant issue regarding the safety or lack of effectiveness of an approved drug." The bill, which never came to a vote, would also have ramped up enforcement by imposing civil penalties on manufacturers that fail to follow through on their study commitments.

Vaughan said the government's current post-market enforcement authority is toothless. Pulling a drug from the market for safety reasons requires concrete proof of danger, he noted, and under existing rules, studies controlled and sponsored by the industry are key sources of such evidence. Ultimately, he said, regulators lack "resources to keep these guys honest as to whether they're giving the public good science on the safety and the effectiveness of these drugs."

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Prescription Drug Makers Have Not Begun Many Pending Post-Market Studies On Newly Approved Drugs, FDA Says
Main Category: Pharma Industry News
Article Date: 06 Feb 2007 - 22:00 PST

Prescription drug companies as of Sept. 30, 2006, have not begun 71% of post-approval studies that were promised as a condition of FDA approval of a drug, according to an annual FDA report released on Thursday, Bloomberg/Long Island Newsday reports.

Drug makers often agree to conduct post-market studies of safety, dosage and other factors of a drug to receive FDA approval. According to the agency, 899 of 1,259 pending post-approval studies have not been started (Bloomberg/Long Island Newsday, 2/2). FDA found that of the post-approval studies that had been initiated, 184 were on or ahead of schedule, 144 had been submitted for FDA review or terminated, and 31 were labeled as "delayed."

The FDA report did not indicate the number of drugs covered by the studies, as some drugs require multiple studies. In addition, the report did not specify over what time period the studies had been requested. Not all of the uninitiated studies were considered late by the agency, because drug companies and FDA can spend months discussing study design (Bloomberg/Los Angeles Times, 2/2).

Post-approval studies usually are voluntary, so FDA cannot impose fines or penalties on drug companies who do not conduct the studies.

Bill Vaughan, senior policy analyst with Consumers Union, asked, "How can the FDA claim it is committed to improving drug safety when it can't even get drug makers to do the studies they promise?

Should consumers really feel safe when two out of three studies aren't being done, and the FDA doesn't even have the authority to get them done?" FDA spokesperson Susan Cruzan said the agency is working to improve its ability to track and monitor post-approval studies and is looking to work with drug makers to complete the studies.

Alan Goldhammer, deputy vice president for regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said that drug companies are committed to finishing post-approval studies but sometimes
have difficulty finding study participants (Bloomberg/Long Island Newsday, 2/2).

http://www.medicalnewstoday.com/medicalnews.php?newsid=38919
Many Post-Market Studies Of New Medications Not Completed, FDA Report States
Main Category: Pharma Industry News
Article Date: 07 Mar 2006 - 14:00 PST

Many post-market studies that pharmaceutical companies have promised to conduct on medications approved by FDA remain uncompleted, according to an annual report released by the agency on Thursday, the Wall Street Journal reports.

According to the report, which appeared on the FDA Web site, 797, or 65%, of 1,231 post-market studies on new medications were listed as "pending" and had not begun as of Sept. 30, and 28 studies were listed as "delayed." The report also states that 231 studies, or 19%, were listed as "ongoing," and that pharmaceutical companies had submitted 172 studies, or 14%, to FDA.

The post-market studies were promised by 54 pharmaceutical companies, and some dated back several years. In most cases, FDA does not have to authority to require pharmaceutical companies to complete post-market studies. Sens. Chuck Grassley (R-Iowa) and Christopher Dodd (D-Conn.) have introduced a bill that would provide FDA with more authority to require pharmaceutical and medical device companies to complete the post-market studies.

Biologics Studies
The FDA report also examined post-market studies that pharmaceutical companies promised to conduct on biologics, or medications made from live materials, rather than chemicals. According to the report, 118 of 321 post-market studies of new biologics were listed as pending, and 53 were listed as delayed. In addition, the report states that 94 studies were listed as ongoing and that pharmaceutical companies had submitted 56 studies to FDA (Corbett Dooren, Wall Street Journal, 3/3).

"Reprinted with permission from http://www.kaisernetwork.org. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . C 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.